1. SAN DIEGO, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced today that the company will participate in the 11th annual Partnership Opportunities in Drug Delivery (PODD) Conference, October 28-29, 2021 in Boston.

    Progenity's Vice President of Strategy and Operations, Chris Wahl, MD, MBA, will participate in the panel titled "Orally Ingestible Devices for Biologics Delivery" on Friday, October 29, at 9:35 a.m. ET. The panel discussion will be live-streamed and will be available on demand for three months following the conference to registered attendees.

    The session will explore oral delivery of biologics and the many technological approaches currently under investigation and showing…

    SAN DIEGO, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced today that the company will participate in the 11th annual Partnership Opportunities in Drug Delivery (PODD) Conference, October 28-29, 2021 in Boston.

    Progenity's Vice President of Strategy and Operations, Chris Wahl, MD, MBA, will participate in the panel titled "Orally Ingestible Devices for Biologics Delivery" on Friday, October 29, at 9:35 a.m. ET. The panel discussion will be live-streamed and will be available on demand for three months following the conference to registered attendees.

    The session will explore oral delivery of biologics and the many technological approaches currently under investigation and showing promising results, including Progenity's Oral Biotherapeutic Delivery System (OBDS), which is designed to enable needle-free systemic delivery of large-molecule biologics in a liquid formulation.

    In addition to participating on the panel, the company will also be meeting with potential and existing pharmaceutical partners. Progenity recently signed its third partnership with a major pharmaceutical company to evaluate delivery of large molecules using the OBDS platform.

    About the Oral Biotherapeutic Delivery System (OBDS)

    Progenity's Oral Biotherapeutic Delivery System (OBDS) is an ingestible capsule designed for needle-free, oral delivery of large molecules, including monoclonal antibodies, peptides, and nucleic acids. These substances cannot survive stomach acids and are too large to be absorbed in the intestine and are therefore currently delivered by injection. Once swallowed, the OBDS capsule is designed to transit the intestinal tract and trigger in the small intestine, where it will use liquid jet release to inject drug directly into the small intestine for optimal bioavailability.

    The OBDS platform is designed to enable delivery of liquid drug, eliminating the need for reformulation, and allows for industry-leading dosing of over 50 mg of proteins and over 5 mg of peptides. This makes the technology broadly applicable for large molecule candidates. With more frequent administration, oral delivery has the potential to improve drug efficacy and safety as compared to current injection regimens.

    Progenity is currently conducting preclinical studies to demonstrate the bioavailability of its lead candidates PGN-OB1 (adalimumab) and PGN-OB2 (liraglutide, a GLP-1 agonist). In addition, the company has entered an agreement with Ionis Pharmaceuticals to evaluate the OBDS for delivery of antisense oligonucleotides. Progenity has also entered agreements with two leading pharmaceutical companies to evaluate delivery of their proprietary drugs via the OBDS platform.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including Progenity's ability to successfully develop and commercialize its products under development, the uncertainties inherent in the development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Progenity's Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  2. SAN DIEGO, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,112,403 for assessment of preeclampsia using assays for free and dissociated placental growth factor.

    The patent is directed to methods, compositions, and kits for detecting and measuring free and dissociated placental growth factor (PlGF) levels in biological samples. PlGF is well established as an important biomarker for the assessment of preeclampsia, and recent studies have revealed the importance of distinguishing between the free and bound forms when assessing the complex physiological pathways involved in preeclampsia…

    SAN DIEGO, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,112,403 for assessment of preeclampsia using assays for free and dissociated placental growth factor.

    The patent is directed to methods, compositions, and kits for detecting and measuring free and dissociated placental growth factor (PlGF) levels in biological samples. PlGF is well established as an important biomarker for the assessment of preeclampsia, and recent studies have revealed the importance of distinguishing between the free and bound forms when assessing the complex physiological pathways involved in preeclampsia.

    "We are pleased the USPTO has granted this patent covering unique and novel methods for determining levels of free and dissociated PlGF, since detection and quantification of both biomarkers are critical for assessing preeclampsia. This discovery helped drive the excellent performance we observed in our clinical verification and validation studies," said Matthew Cooper, PhD, chief scientific officer of Progenity. "Patent protection is important as we pursue partnership opportunities for commercialization of the Preecludia™ test for the benefit of physicians and their patients."

    The Preecludia™ test is expected to target an addressable market of up to $3 billion annually in the United States. In addition to the laboratory-developed test (LDT) immunodiagnostic under development, this test has potential as an in vitro diagnostic (IVD) and point-of-care solution globally. Consistent with the company's recent strategic transformation, Progenity is evaluating commercialization opportunities for launch of the LDT within the United States, and IVD embodiments to access the global opportunity for the Preecludia™ test. The company previously announced successful completion of the clinical validation study and achievement of the primary study endpoint, and is pursuing publication of the study results in a peer-reviewed medical journal.

    Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 pregnant women presenting with signs and symptoms of possible preeclampsia each year. Ultimately, if left undiagnosed and improperly managed, preeclampsia can result in impaired organ function, seizures, stroke, and death in the mother, and may require pre-term delivery of the baby. Preeclampsia can result in both poor health outcomes and significant costs. Preeclampsia is often missed or misdiagnosed because the symptoms are common – appearing in up to 30% of pregnant women in the United States – and can easily be attributed to other causes.

    About the Preecludia™ Test

    The Preecludia rule-out test for preeclampsia has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel, multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is designed to be run from a simple blood draw and is intended to address the unmet need for tools to aid in the assessment and management of preeclampsia. To learn more about preeclampsia and the Preecludia test, the company's virtual R&D day webcast from November 2020 can be viewed here. Results from the Preecludia test verification study were presented at the American College of Obstetricians and Gynecologists (ACOG) 2021 Annual Meeting. The company previously shared topline results from pre-validation testing, followed by successful completion of the clinical validation study and achievement of the primary study endpoint.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Forward-looking statements include statements regarding Progenity's evaluation and pursuit of partnership opportunities for the commercialization of the Preecludia™ test, the estimated addressable market size for preeclampsia and the potential uses for the Preecludia™ test in the United States and globally. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including Progenity's ability to successfully develop and commercialize its products under development, the uncertainties inherent in the development process, such as the regulatory approval process, the timing of regulatory filings, the ability to identify potential partners and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Progenity's Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  3. SAN DIEGO, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced that the company will participate in two upcoming virtual investor conferences:

    • A pre-recorded presentation at H.C. Wainwright's 23rd Annual Global Investment Conference will be available on Progenity's website beginning at 7 a.m. ET / 4 a.m. PT on September 13, 2021, and will remain accessible for 90 days; and

    • A presentation at Baird's 2021 Global Healthcare Conference at 7:55 a.m. ET / 4:55 a.m. PT on September 15, 2021.

    The pre-recorded H.C. Wainwright presentation and the live audio webcast and archived replay of the Baird presentation will be available in the Investors section of the company's website at www.progenity.com/presentations

    SAN DIEGO, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced that the company will participate in two upcoming virtual investor conferences:

    • A pre-recorded presentation at H.C. Wainwright's 23rd Annual Global Investment Conference will be available on Progenity's website beginning at 7 a.m. ET / 4 a.m. PT on September 13, 2021, and will remain accessible for 90 days; and



    • A presentation at Baird's 2021 Global Healthcare Conference at 7:55 a.m. ET / 4:55 a.m. PT on September 15, 2021.

    The pre-recorded H.C. Wainwright presentation and the live audio webcast and archived replay of the Baird presentation will be available in the Investors section of the company's website at www.progenity.com/presentations.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  4. SAN DIEGO, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, today announced the closing of its previously announced underwritten public offering of 40,000,000 shares of its common stock and warrants to purchase up to 40,000,000 shares of its common stock, at a public offering price of $1.00 per share and associated warrant.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The warrants have an exercise price of $1.00 per share, are exercisable immediately, and will expire five years following the date of issuance.

    In addition, Progenity has granted the underwriter a 30-day option to purchase up to an additional 6,000,000 shares of its common…

    SAN DIEGO, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, today announced the closing of its previously announced underwritten public offering of 40,000,000 shares of its common stock and warrants to purchase up to 40,000,000 shares of its common stock, at a public offering price of $1.00 per share and associated warrant.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The warrants have an exercise price of $1.00 per share, are exercisable immediately, and will expire five years following the date of issuance.

    In addition, Progenity has granted the underwriter a 30-day option to purchase up to an additional 6,000,000 shares of its common stock and/or accompanying warrants to purchase an aggregate of up to 6,000,000 shares of its common stock, which the underwriter has partially exercised for warrants to purchase an aggregate of 1,932,000 shares of common stock. At closing, Progenity received net proceeds from the offering of approximately $37.1 million, after deducting underwriting discounts and commissions and estimated offering expenses. All of the securities in the offering were sold by Progenity.

    A shelf registration statement relating to the offered securities was filed with the Securities and Exchange Commission ("SEC") on July 30, 2021 and was declared effective on August 6, 2021. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website, located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or by email at placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 742-6294 



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  5. SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, today announced the pricing of its previously announced underwritten public offering of 40,000,000 shares of its common stock and warrants to purchase up to 40,000,000 shares of its common stock. Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined public offering price of $1.00 per share of common stock and accompanying warrant, less underwriting discounts and commissions. The warrants have an exercise price of $1.00 per share, are exercisable immediately, and will expire five years following the date of issuance. Progenity expects to receive gross…

    SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, today announced the pricing of its previously announced underwritten public offering of 40,000,000 shares of its common stock and warrants to purchase up to 40,000,000 shares of its common stock. Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined public offering price of $1.00 per share of common stock and accompanying warrant, less underwriting discounts and commissions. The warrants have an exercise price of $1.00 per share, are exercisable immediately, and will expire five years following the date of issuance. Progenity expects to receive gross proceeds from the underwritten public offering of approximately $40 million, before deducting underwriting discounts and commissions and other offering expenses.

    H.C. Wainwright is acting as the sole book-running manager for the offering.

    In addition, Progenity has granted the underwriter a 30-day option to purchase up to an additional 6,000,000 shares of common stock and/or warrants to purchase up to an additional 6,000,000 shares of common stock at the public offering price, less the underwriting discounts and commissions.

    All of the securities being sold in the offering are being offered by Progenity. The offering is expected to close on or about August 24, 2021, subject to the satisfaction of customary closing conditions.

    A shelf registration statement relating to the offered securities was filed with the Securities and Exchange Commission ("SEC") on July 30, 2021 and was declared effective on August 6, 2021. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website, located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov and may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or by email at placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding Progenity's expectations regarding the completion and intended use of the proceeds of the underwritten public offering. In some cases, you can identify these statements by forward-looking words such as "expect," "may," "will," or the negative or plural of these words or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). These forward-looking statements are based on Progenity's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to market and other conditions and the satisfaction of customary closing conditions related to the underwritten public offering. Additional information concerning these and other risks can be found in Progenity's periodic filings with the SEC, including under the heading "Risk Factors" contained therein, as well as the risks identified in the registration statement and the preliminary prospectus supplement relating to the offering. Any forward-looking statements that Progenity makes in this press release speak only as of the date of this press release. Except as required by law, Progenity assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com 

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com 

    (619) 742-6294



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  6. SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, announced today that it intends to offer and sell, subject to market and other conditions, shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

    With respect to the proposed public offering, Progenity expects to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or warrants to purchase shares of its common stock…

    SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, announced today that it intends to offer and sell, subject to market and other conditions, shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

    With respect to the proposed public offering, Progenity expects to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or warrants to purchase shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by Progenity.

    H.C. Wainwright is acting as the sole book-running manager for the offering.

    Progenity intends to use the net proceeds from this offering to support its operations, invest in research and development with respect to its women's health diagnostic tests and its precision medicine platform, and for working capital and general corporate purposes.

    A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission ("SEC") on July 30, 2021 and was declared effective on August 6, 2021. The offering of the shares of common stock and accompanying warrants is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement and the accompanying prospectus and other documents Progenity has filed with the SEC for more complete information about Progenity and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or by email at placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding Progenity's expectations regarding the size, timing and completion and intended use of the proceeds of the proposed underwritten public offering. In some cases, you can identify these statements by forward-looking words such as "expect," "may," "will," or the negative or plural of these words or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). These forward-looking statements are based on Progenity's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to market and other conditions and the satisfaction of customary closing conditions related to the proposed underwritten public offering. Additional information concerning these and other risks can be found in Progenity's periodic filings with the SEC, including under the heading "Risk Factors" contained therein, as well as the risks identified in the registration statement and the preliminary prospectus supplement relating to the offering. Any forward-looking statements that Progenity makes in this press release speak only as of the date of this press release. Except as required by law, Progenity assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 742-6294



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  7. Announced successful completion of the validation study PRO-104 for the Preecludia™ rule out test for preeclampsia and achievement of the primary endpoint of the study protocol

    Recently achieved promising results with the prototype autonomous Oral Biotherapeutics Delivery System in a single oral dose study in a porcine model for lead candidate PGN-OB1

    Implemented cost-cutting measures expected to result in approximately $97 million of cost savings on an annual run-rate basis

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics, today…

    Announced successful completion of the validation study PRO-104 for the Preecludia™ rule out test for preeclampsia and achievement of the primary endpoint of the study protocol

    Recently achieved promising results with the prototype autonomous Oral Biotherapeutics Delivery System in a single oral dose study in a porcine model for lead candidate PGN-OB1

    Implemented cost-cutting measures expected to result in approximately $97 million of cost savings on an annual run-rate basis

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics, today provided a corporate update and reported financial results for the second quarter ended June 30, 2021.

    In the second quarter Progenity initiated a strategic transformation directed at significantly reducing its cash burn rate whilst accelerating its transition to an innovation-led biotech company focused on its oral delivery of biomolecules and its GI-IBD platforms. The company has implemented cost-cutting measures that are expected to result in cost savings of approximately $97 million on an annual run-rate basis, and it plans to continue to evaluate and implement further cost-saving measures.

    The company also recently announced the successful completion of the validation study, PRO-104, for its Preecludia™ rule out test for preeclampsia. Importantly, Preecludia™ achieved the primary endpoint of the study protocol and demonstrated strong performance consistent with what was achieved in the PRO-129 verification study and pre-validation set.

    Separately, during the second quarter the company initiated preclinical studies of its lead candidates PGN-OB1 (adalimumab a monoclonal) and PGN-OB2 (liraglutide, a GLP 1 agonist) utilizing for the first time its prototype autonomous Oral Biotherapeutics Delivery System (OBDS) in a swine model. Data from a recent study demonstrated that, in animals with significant drug detected, average bioavailability levels were approximately 15% with maximum levels up to 44% of IV for adalimumab following a single dose, highlighting the vast potential for this program.

    "Our GI innovation pipeline is progressing with both the Oral Biotherapeutics Delivery System and the Drug Delivery System now available as fully autonomous prototype devices that will enable key studies to be performed to advance our programs and provide potential partnership opportunities. I'm also excited by the successful outcome for the Preecludia™ PRO-104 validation study results, which we expect the independent PIs to publish soon, and we are making good progress with our single molecule platform. I'm also pleased with the implementation and execution of our company transformation with substantial costs savings already being achieved and with more anticipated in the coming months. We are projecting multiple key catalysts in the next quarter and beyond, and we look forward to sharing those results in the near future," said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity.

    Second Quarter 2021 Results and Other Corporate Highlights

    • Successful completion of the validation study for the Preecludia™ rule-out test for preeclampsia. Achieved the primary endpoint of the study protocol. Demonstrated strong performance and a high NPV consistent with what was achieved in the PRO-129 verification study and pre-validation set.



    • Completed closure of Ann Arbor laboratory and refocus of resources toward innovation pipeline. Operating expenses reduction plan is on track to achieve target.



    • Initiated preclinical studies of PGN-OB1 (adalimumab + OBDS) and PGN-OB2 (GLP 1 agonist + OBDS). Initial data is promising with average bioavailability of approximately 15% in animals where significant drug was detected, and reaching up to 44%. Existing pharma partnerships advancing as expected.



    • Announced the formation of its Inflammatory Bowel Disease Clinical Advisory Board. The advisory board includes respected researchers and clinicians who are thought leaders in the research and treatment of inflammatory bowel disease (IBD).



    • Ongoing clinical study in ulcerative colitis patients using adalimumab delivered by enema as proxy for PGN-001 (adalimumab + Drug Delivery System (DDS)). First four subjects have completed dosage regimen with promising initial results Clinical advisory board to meet next month to review data and help finalize design of the first human feasibility study delivering Humira with the DDS.



    • Announced the appointment of Surbhi Sarna to its board of directors effective July 1, 2021. Ms. Sarna's medical device experience and her focus on development of strategic partnerships will prove valuable as the company advances its innovation pipeline.



    • In June 2021, raised approximately $40.0 million in gross proceeds from a private placement with two leading healthcare-focused investment funds.

    Second Quarter 2021 Financial Results

    Comparison of Three Months Ended June 30, 2021 and March 31, 2021

    Operating expenses were $36.1 million for the three months ended June 30, 2021, compared to $31.6 million for the three months ended March 31, 2021.

    Net loss was $78.5 million for the three months ended June 30, 2021 and net loss per share was $1.23, compared to a net loss of $32.3 million and a net loss per share of $0.56 for the three months ended March 31, 2021.

    Net loss from discontinued operations was $37.1 million for the three months ended June 30, 2021 and net loss per share for discontinued operations was $0.58, compared to a net loss from discontinued operations of $14.8 million and a net loss per share of $0.26 for the three months ended March 31, 2021.

    Comparison of Three Months Ended June 30, 2021 and 2020

    Operating expenses were $36.1 million for the three months ended June 30, 2021, compared to $26.5 million for the three months ended June 30, 2020.

    Net loss was $78.5 million for the three months ended June 30, 2021 and net loss per share was $1.23, compared to a net loss of $53.1 million and a net loss per share of $6.11 for the three months ended June 30, 2020.

    Net loss from discontinued operations was $37.1 million for the three months ended June 30, 2021 and net loss per share for discontinued operations was $0.58, compared to a net loss from discontinued operations of $20.1 million and a net loss per share of $2.31 for the three months ended June 30, 2020.

    Webcast and Conference Call Information

    Progenity will host a webcast and conference call to discuss the second quarter financial results and answer investment community questions today, Thursday, August 12, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 8635609. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to develop and commercialize our testing products, our ability to innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding future test volumes and revenues, our expectations regarding our in network position, anticipated capacity for our tests, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the period ended December 31, 2020 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.

    Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436

    Progenity, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

      Three Months Ended 
      June 30,

    2021
      March 31,

    2021
     
    Revenues $463  $167 
    Cost of sales      
    Gross profit  463   167 
    Operating expenses:      
    Research and development  13,401   11,673 
    Selling and marketing  2,006   1,858 
    General and administrative  20,709   18,100 
    Total operating expenses  36,116   31,631 
    Loss from operations  (35,653)  (31,464)
    Interest expense  (3,502)  (3,520)
    (Loss) gain on warrant liability  (5,146)  2,650 
    Interest and other income, net  2,901   14,873 
    Loss from continuing operations  (41,400)  (17,461)
    Loss from discontinued operations  (37,131)  (14,803)
    Net loss $(78,531) $(32,264)
    Net loss per share from continuing operations, basic and diluted $(0.65) $(0.30)
    Net loss per share from discontinued operations, basic and diluted $(0.58) $(0.26)
    Net loss per share, basic and diluted $(1.23) $(0.56)
    Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted  63,942,298   57,493,800 
             

    Progenity, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

      Three Months Ended

    June 30,
     
      2021  2020 
           
    Revenues $463  $ 
    Cost of Sales      
    Gross profit  463    
    Operating Expenses:      
    Research and development  13,401   12,234 
    Selling and marketing  2,006   1,547 
    General and administrative  20,709   12,702 
    Total operating expenses  36,116   26,483 
    Loss from operations  (35,653)  (26,483)
    Interest expense  (3,502)  (2,489)
    Loss on warrant liability  (5,146)   
    Interest and other income (expense), net  2,901   (3,751)
    Loss from continuing operations  (41,400)  (32,723)
    Loss from discontinued operations  (37,131)  (20,060)
    Net loss  (78,531)  (52,783)
    Dividend paid to preferred shareholders     (268)
    Net loss attributable to common stockholders $(78,531) $(53,051)
    Net loss per share from continuing operations, basic and diluted $(0.65) $(3.77)
    Net loss per share from discontinued operations, basic and diluted $(0.58) $(2.31)
    Net loss per share attributable to common stockholders, basic and diluted $(1.23) $(6.11)
    Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted  63,942,298   8,687,250 
             

    Progenity, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)

      June 30,

    2021
      December 31,

    2020
         (1)
    Assets     
    Current assets:     
    Cash and cash equivalents $65,991  $91,520 
    Accounts receivable, net  5,047   6,634 
    Prepaid expenses and other current assets  13,107   8,107 
    Current assets of disposal group held for sale  30,181   20,077 
    Total current assets  114,326   126,338 
    Property and equipment, net  5,474   8,660 
    Other assets  146   169 
    Long-term assets of disposal group held for sale     19,273 
    Total assets $119,946  $154,440 
    Liabilities and Stockholders' Deficit     
    Current liabilities:     
    Accounts payable $14,560  $12,657 
    Accrued expenses and other current liabilities  58,172   51,206 
    Current portion of mortgages payable and capital lease obligations  202   338 
    Current liabilities of disposal group held for sale  12,703   8,469 
    Total current liabilities  85,637   72,670 
    Mortgages payable and capital lease obligations, net of current portion  1,238   1,317 
    Convertible notes, net  157,533   158,886 
    Embedded derivative liability  388   18,370 
    Other long-term liabilities  14,759   8,239 
    Long-term liabilities of disposal group held for sale     1,952 
    Total liabilities $259,555  $261,434 
    Stockholders' deficit:     
    Common stock  82   59 
    Additional paid-in capital  531,156   452,992 
    Accumulated deficit  (652,069)  (541,274)
    Treasury stock  (18,778)  (18,771)
    Total stockholders' deficit  (139,609)  (106,994)
    Total liabilities and stockholders' deficit $119,946  $154,440 
             

    1. The condensed consolidated balance sheet data at December 31, 2020 has been derived from the audited consolidated financial statements, with adjustments to reflect the assets and liabilities held for sale.



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  8. SAN DIEGO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced that it will report second quarter 2021 financial results on Thursday, August 12, 2021 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers or 914-800-3810 for international callers, and entering the conference code: 8635609. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity…

    SAN DIEGO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced that it will report second quarter 2021 financial results on Thursday, August 12, 2021 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers or 914-800-3810 for international callers, and entering the conference code: 8635609. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  9. SAN DIEGO, July 29, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced today successful completion of the validation study for its Preecludia™ rule-out test for preeclampsia and achievement of the primary endpoint of the study protocol.

    The PRO-104 clinical validation study was a prospective, multi-center, observational study with over 1,300 enrolled subjects. Test specimens were collected from pregnant patients aged 18 to 45 years and 28 0/7 to 36 6/7 weeks' gestational age. Analysis was blinded. Patients in the study cohort presented with potential signs and symptoms of preeclampsia at 20 labor and delivery triage sites across all major regions of the United States. Patient demographics…

    SAN DIEGO, July 29, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced today successful completion of the validation study for its Preecludia™ rule-out test for preeclampsia and achievement of the primary endpoint of the study protocol.

    The PRO-104 clinical validation study was a prospective, multi-center, observational study with over 1,300 enrolled subjects. Test specimens were collected from pregnant patients aged 18 to 45 years and 28 0/7 to 36 6/7 weeks' gestational age. Analysis was blinded. Patients in the study cohort presented with potential signs and symptoms of preeclampsia at 20 labor and delivery triage sites across all major regions of the United States. Patient demographics were consistent with the at-risk U.S. population.

    "We are proud to have achieved the primary endpoint of the PRO-104 study protocol, demonstrating that the Preecludia test can significantly distinguish between the presence and absence of preeclampsia, with the initial unblinding and analysis performed by an independent third party," said Matthew Cooper, PhD, Chief Scientific Officer, Progenity. "The test's high negative predictive value, which achieved the targeted range determined from our market research and clinician feedback, validates its utility in ruling out preeclampsia, and positions the laboratory-developed test for launch in the United States. We intend to soon publish our results in a peer-reviewed medical journal. Because of embargo considerations, we are limited in what we can share today."

    Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 pregnant women presenting with signs and symptoms of possible preeclampsia each year. Ultimately, if left undiagnosed and improperly managed, preeclampsia can result in impaired organ function, seizures, stroke, and death in the mother, and may require pre-term delivery of the baby. Preeclampsia can result in both poor health outcomes and significant costs. Preeclampsia is often missed or misdiagnosed because the symptoms are common – appearing in up to 30% of pregnant women in the United States – and can easily be attributed to other causes.

    "Despite increasing rates of preeclampsia, there have been no significant advancements in diagnostic assessment tools in the United States in decades," stated Martin Chavez, MD, FACOG, Maternal-Fetal Medicine Specialist. "The Preecludia test will be an invaluable tool to support physicians in the differential diagnosis of patients with signs and symptoms of preeclampsia," continued Dr. Chavez, who has an active practice in high-risk obstetrics as part of a leading NYC academic medical center.

    The Preecludia test is expected to target an addressable market of up to $3 billion in the United States. In addition to the laboratory-developed test (LDT) immunodiagnostic under development, this test has potential as an in vitro diagnostic (IVD) and point-of-care solution globally. Consistent with the company's recent strategic transformation, Progenity is evaluating commercialization opportunities for launch of the LDT within the United States, and IVD embodiments to access the global opportunity for the Preecludia™ test.

    "We are excited to announce the successful completion of the validation study for the Preecludia test and achievement of the primary endpoint, which supports our intended use in the target patient population," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "Successful completion of the PRO-104 study is another significant step toward equipping physicians with a valuable new tool that will transform the clinical management of patients at risk of preeclampsia and support a compelling health economic benefit for society."

    About the Preecludia™ Test

    The Preecludia rule-out test for preeclampsia has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel, multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is designed to be run from a simple blood draw and is intended to address the unmet need for tools to aid in the assessment and management of preeclampsia. To learn more about preeclampsia and the Preecludia test, the company's virtual R&D day webcast from November 2020 can be viewed here. Results from the Preecludia test verification study were presented at the American College of Obstetricians and Gynecologists (ACOG) 2021 Annual Meeting, and the company previously shared topline results from pre-validation testing.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of women's health, gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this press release are forward-looking statements, including statements regarding the efficacy and potential utility of the Preecludia test, the timing for launch of the Preecludia test, the potential addressable market for the Preecludia test; the potential for IVD embodiments of the Preecludia test; and any potential future commercialization opportunities. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including Progenity's ability to successfully develop and commercialize its products under development, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Progenity's Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  10. SAN DIEGO, June 30, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced the appointment of Surbhi Sarna to its board of directors effective July 1, 2021. Ms. Surbhi's medical device experience and her focus on development of strategic partnerships will prove valuable as the company advances its innovation pipeline.

    "As part of our strategic transformation, we are sharpening our focus on efforts to develop the drug discovery and delivery systems of the future. We are delighted that Surbhi Sarna has agreed to join the Progenity Board of Directors to support these efforts," said Harry Stylli, Ph.D., CEO, Chairman of the Board, and co-founder of Progenity. "Surbhi's expertise with the development…

    SAN DIEGO, June 30, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, announced the appointment of Surbhi Sarna to its board of directors effective July 1, 2021. Ms. Surbhi's medical device experience and her focus on development of strategic partnerships will prove valuable as the company advances its innovation pipeline.

    "As part of our strategic transformation, we are sharpening our focus on efforts to develop the drug discovery and delivery systems of the future. We are delighted that Surbhi Sarna has agreed to join the Progenity Board of Directors to support these efforts," said Harry Stylli, Ph.D., CEO, Chairman of the Board, and co-founder of Progenity. "Surbhi's expertise with the development of FDA-approved medical technologies and her strategic insight will be advantageous as we advance our diagnostic and therapeutic platforms towards the clinic and on to commercialization."

    Surbhi Sarna founded nVision Medical in 2011, where as CEO, she led the company to develop a first-of-its-kind microcatheter for the detection of ovarian cancer. Following acquisition by Boston Scientific in 2018, Surbhi led the commercial effort of the nVision technology at Boston Scientific until 2020. Prior to the founding of nVision, Ms. Sarna held roles in healthcare engineering at BioCardia and Abbott Vascular.

    "Progenity's innovative therapeutics and diagnostics programs show substantial promise to change the existing paradigms for diagnosis and treatment of gastrointestinal diseases and the systemic delivery of biologics," said Ms. Sarna. "I am excited to contribute strategic insight in support of the clinical and regulatory development of Progenity's novel drug-device combinations."

    Ms. Sarna is currently a Visiting Partner at Y Combinator, and is a board member of Penumbra, Inc., serving on its audit committee and nominating and corporate governance committee. She is also on the board of trustees at Astia, an organization committed to leveling the playing field by providing access to capital and networks to women entrepreneurs. She is an inventor of numerous patented technologies and has received many awards and recognitions, including the Forbes 30 Under 30 list (2014), the Inc. Magazine Female Founders 100 list (2019), the MD+DI MedTech 30 Under 30 list (2016), MedTech Women's Ferolyn Powell Leadership Award (2018), and the Fogarty Institute's Company of the Year Award (2018). She received a Bachelor of Science in Molecular and Cell Biology from the University of California, Berkeley.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including Progenity's ability to successfully develop and commercialize its products under development, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Progenity's Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  11. SAN DIEGO, June 17, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced the formation of its Inflammatory Bowel Disease Clinical Advisory Board. The advisory board includes respected researchers and clinicians who are thought leaders in the research and treatment of inflammatory bowel disease (IBD).

    Progenity is developing a pipeline of therapeutics and diagnostics that are designed to act at the site of disease in the gastrointestinal tract with a focus on IBD. Progenity's Targeted Therapeutics program consists of drug-device combination products under development that have the potential to deliver high concentrations of proprietary drug formulations via a novel, orally ingestible…

    SAN DIEGO, June 17, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced the formation of its Inflammatory Bowel Disease Clinical Advisory Board. The advisory board includes respected researchers and clinicians who are thought leaders in the research and treatment of inflammatory bowel disease (IBD).

    Progenity is developing a pipeline of therapeutics and diagnostics that are designed to act at the site of disease in the gastrointestinal tract with a focus on IBD. Progenity's Targeted Therapeutics program consists of drug-device combination products under development that have the potential to deliver high concentrations of proprietary drug formulations via a novel, orally ingestible capsule to the precise site of disease along the gastrointestinal (GI) tract. The Drug Delivery System (DDS) capsule is designed to maximize the available dose at the site of disease to potentially improve efficacy and reduce systemic toxicity.

    Progenity's lead Targeted Therapeutics product candidates, PGN-001 (liquid adalimumab delivered by DDS) and PGN-600 (liquid tofacitinib delivered by DDS), are being developed with an initial priority for ulcerative colitis, part of the estimated $15 billion IBD market.

    The advisory board will provide clinical and strategic guidance on Progenity's ingestible therapeutics and diagnostics pipeline, as the company transitions from preclinical to clinical studies. Dr. William Sandborn will chair the board, which includes Dr. Geert D'Haens, Dr. Bruce Sands, and Dr. Séverine Vermeire.

    "I am excited to chair the Progenity IBD clinical advisory board. The data generated by Progenity to date is compelling for the potential of therapeutics delivered locally with the DDS technology to improve efficacy and safety and enable combination therapy. I look forward to further working with Progenity on the clinical development plan for PGN-001 and PGN-600," said William Sandborn, MD, Professor of Medicine at the University of California San Diego.

    The first official advisory board meeting will be held this summer to review data recently announced around the clinical performance of Progenity's drug delivery system (DDS), preclinical data for PGN-600, and initial data from an ongoing clinical study in which adalimumab is being delivered by enema as a proxy for delivery with the DDS in moderate to severe colitis patients. This data will enable the clinical advisory board to refine Progenity's clinical development plan for its lead candidates with clinical trials expected to begin in 2022.

    "I am honored to join the Progenity IBD clinical advisory board. Their novel approach to the treatment of IBD has great potential and I look forward to helping guide their clinical programs. Not only do they have two promising lead candidates in PGN-001 and PGN-600, but their development platform can support not only these programs but other IBD therapeutics. Their Recoverable Sampling System allows for collection and preservation of analytes in the gastrointestinal tract which can then potentially be used to identify signatures of disease severity, predict response to therapeutic intervention and optimize dosing," said Bruce Sands MD, MS, Professor of Medicine at Icahn School of Medicine at Mount Sinai and Chief of the Division of Gastroenterology, Mount Sinai Health System.

    In addition to participating in the IBD clinical advisory board, each board member will also continue in consulting roles where they help guide the strategy and development of Progenity's gastrointestinal health programs.

    "We are honored to have leading minds in IBD clinical research contributing to our efforts to further study and develop our innovative pipeline," said Harry Stylli, PhD, CEO, Chairman of the Board, and co-founder of Progenity. "We believe these product candidates have the potential to improve diagnosis and treatment for the millions of patients suffering from inflammatory bowel diseases."

    Short biographies for the clinical advisory board members are below, with headshots available upon request.

    William Sandborn, MD

    Dr. William Sandborn is Professor of Medicine at the University of California San Diego (UCSD) and is the Chief Medical Officer of Shoreline Biosciences. He completed medical school and an internal medicine residency at Loma Linda University, followed by completion of a gastroenterology fellowship at the Mayo Clinic. From 1993-2010, he was on the faculty of the Mayo Clinic, rising to Professor of Medicine, Vice Chairman of the Division of Gastroenterology and Hepatology, and Associate Dean of Research for Intellectual Property and Industry Relations. From 2011-2021 he was Professor of Medicine and Chief of the Division of Gastroenterology at the University of California San Diego (UCSD), where he continues as Professor of Medicine. Dr. Sandborn co-founded Shoreline Biosciences in 2020, co-founded Santarus in 1998 (acquired by Salix Pharmaceuticals in 2013), and was a member of the board of directors for Prometheus Biosciences from 2017-2021. Dr. Sandborn has published 849 peer-reviewed articles to date, and he was awarded the Sherman Prize for his work in inflammatory bowel disease in 2019.

    Geert D'Haens, MD, PhD

    Dr. Geert D'Haens is Professor of Gastroenterology at the Academic Medical Center at the University of Amsterdam, where he leads the IBD Unit. Currently, Dr. D'Haens leads a group of more than 35 IBD researchers in the AMC. He is also Medical Director of Robarts Clinical Trials in Europe and former chairman of IOIBD, the international organization for study of IBD. After graduation at the University of Leuven, Belgium, he was trained in gastroenterology, gastrointestinal endoscopy and inflammatory bowel diseases at the University Hospitals in Leuven and at the University of Chicago Hospitals under the mentorship of Paul Rutgeerts and Steven Hanauer, respectively. He completed his PhD thesis in 1996 on mechanisms causing postoperative recurrence of Crohn's disease. After that, most of his research efforts went into the mechanism of action of new IBD drugs, the development of endoscopic endpoints and surrogate markers for IBD and the effect of early intervention with anti-TNF. In 1999, he co-founded ECCO, the European Crohn's and Colitis Organization. He has authored more than 400 peer-reviewed articles so far and participates in many drug development programs and clinical trials for IBD.

    Bruce Sands, MD, MS

    Dr. Bruce Sands is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. Dr. Sands was awarded his BA and MD from Boston University, and trained in internal medicine at the Hospital of the University of Pennsylvania. After completing GI fellowship at the Massachusetts General Hospital, he joined the faculty of Harvard Medical School and served as the Acting Chief of the Gastrointestinal Unit at MGH before moving to Mount Sinai in 2010 as Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Sands is widely recognized for his clinical investigations of new therapeutics for the inflammatory bowel diseases and has published over 250 original manuscripts. He was the lead investigator of the landmark studies ACCENT 2, UNIFI, and VARSITY, published in the New England Journal of Medicine.

    Séverine Vermeire, MD, PhD

    Dr. Séverine Vermeire is Head of the Department of Chronic Diseases & Metabolism (CHROMETA) at the KU Leuven. Since 2003, Dr. Vermeire has been a staff member at the Gastroenterology Department of the University Hospitals Leuven and was appointed Full Professor of Medicine at the KU Leuven. Dr. Vermeire obtained her MD degree and then her PhD at the KU Leuven. She further trained at the Universidad Nacional de Asuncion, Paraguay, at the Wellcome Trust Centre for Human Genetics, University of Oxford, UK, and at the Montreal General Hospital (McGill University) in Canada. She is actively involved as principal investigator in randomized clinical trials with new therapeutic compounds and has been lead investigator on several of these programs. Her scientific work resulted in more than 500 peer-reviewed articles and focuses on the role of the microbiome and genetic susceptibility in IBD and on identifying predictive signatures of treatment response. Dr. Vermeire participated in the International iCHOM consortium on development of Patient-Centered Outcomes for Inflammatory Bowel Disease. She was awarded several grants including an Advanced H2020-European Research Council (ERC) Grant (2016-2021). She served as president of the European Crohn's and Colitis Organization (ECCO) from 2014-2016 and as president of the Belgian IBD Research & Development (BIRD) Group from 2011-2013.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including Progenity's ability to successfully develop and commercialize its products under development, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Progenity's Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  12. SAN DIEGO, June 15, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced that Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity, will participate in a fireside chat at the virtual Raymond James 2021 Human Health Innovation Conference at 10:40 a.m. ET / 7:40 a.m. PT on Tuesday, June 22, 2021.

    A live webcast and archive of the fireside chat will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics…

    SAN DIEGO, June 15, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced that Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity, will participate in a fireside chat at the virtual Raymond James 2021 Human Health Innovation Conference at 10:40 a.m. ET / 7:40 a.m. PT on Tuesday, June 22, 2021.

    A live webcast and archive of the fireside chat will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  13. SAN DIEGO, June 10, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, today announced that it has entered into a definitive securities purchase agreement with two leading healthcare-focused investment funds for the sale of units consisting of shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to Progenity of approximately $40 million, before deducting placement agent commissions and other offering expenses.

    Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Progenity will issue units…

    SAN DIEGO, June 10, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), an innovative biotechnology company, today announced that it has entered into a definitive securities purchase agreement with two leading healthcare-focused investment funds for the sale of units consisting of shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to Progenity of approximately $40 million, before deducting placement agent commissions and other offering expenses.

    Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Progenity will issue units representing an aggregate of 16,194,332 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 16,194,332 shares of common stock. The aggregate purchase price of each unit, which consists of one share of common stock (or pre-funded warrants in lieu thereof) plus a warrant to purchase one share of common stock, is $2.47. The warrants will have a per share exercise price of $2.84 and may be exercised at any time on or after the closing date and through the fifth anniversary of the closing date. The price per unit was based in part upon the average of the last five closing prices of the common stock on the Nasdaq Global Market. If exercised for cash, the warrants would result in additional gross proceeds to Progenity of up to approximately $46 million.

    The private placement is expected to close on June 14, 2021, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Progenity with the Securities and Exchange Commission ("SEC").

    Progenity intends to use the net proceeds to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform, and for working capital and general corporate purposes.

    Piper Sandler & Co. served as lead placement agent on the offering with Raymond James & Associates, Inc. acting as co-placement agent.

    The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Progenity has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's expectations regarding the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the expected receipt of proceeds from the private placement, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties related to market conditions and the completion of the offerings on the anticipated terms or at all, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619-743-6294)



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  14. Closure of genetics lab and other operational improvements expected to result in approximately 70% reduction of annual capital required for operations – from more than $180 million currently to targeted operating expenses of ~$50 million in 2022

    Continuing to seek opportunities to generate non-dilutive capital through partnerships and strategic alternatives for non-core assets, including Avero Diagnostics, which may help fund the company

    Focused on delivering on exciting 2021 and 2022 R&D pipeline with the PreecludiaTMtest, gastrointestinal (GI) health, and oral biopharmaceutical program milestones
      
    Management to host webcast and conference call today at 8:30 a.m. ET / 5:30 a.m. PT

    SAN DIEGO, June 02, 2021 (GLOBE NEWSWIRE) -- Progenity

    Closure of genetics lab and other operational improvements expected to result in approximately 70% reduction of annual capital required for operations – from more than $180 million currently to targeted operating expenses of ~$50 million in 2022

    Continuing to seek opportunities to generate non-dilutive capital through partnerships and strategic alternatives for non-core assets, including Avero Diagnostics, which may help fund the company

    Focused on delivering on exciting 2021 and 2022 R&D pipeline with the PreecludiaTM test, gastrointestinal (GI) health, and oral biopharmaceutical program milestones

      

    Management to host webcast and conference call today at 8:30 a.m. ET / 5:30 a.m. PT

    SAN DIEGO, June 02, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced a transformation strategy that will focus the company primarily on its robust R&D pipeline and better position the business for future growth. To achieve this vision, simplify its business model, and unlock shareholder value, the company will seek to reallocate resources to R&D and materially reduce operating expenditures by approximately 70%.

    • Cost Realignment. Progenity will discontinue providing genetic laboratory-developed test services through its Ann Arbor, Michigan CLIA-certified laboratory and cease offering its Preparent® Carrier Test, Innatal® Prenatal Screen, Riscover® Hereditary Cancer Test, and Resura® Prenatal Test. This strategic transformation is expected to be completed over the next approximately 60 days and will include a reduction in force of approximately 374 employees across Progenity and Avero, or approximately 56% of its total workforce. The transformation is also expected to result in annualized cost savings of approximately $130 million in SG&A. The company's capital requirements after accounting for the costs of the transformation are expected to be approximately $4-5 million per month before any non-dilutive inflows.



    • Opportunities for Non-Dilutive Capital Infusion. Progenity's in-network affiliate lab, Avero Diagnostics, is approaching operating profitability, with growing revenues projected to be $35-40 million for 2021 derived from anatomic pathology, genetic testing and infectious diseases. Progenity is evaluating strategic opportunities for Avero to generate non-dilutive capital that may help fund the company.



    • Focus on Innovation. Progenity's continuous pursuit of innovative solutions seeks to provide near-term commercial applications while also developing the drug delivery systems of the future, with critical near-term milestones across its PreecludiaTM pre-eclampsia rule-out test, Drug Delivery System (DDS) platform, and Oral Biopharmaceutical Delivery System (OBDS).

    Drug Pipeline

    • Continued development of GI-targeted therapeutics differentiated by its DDS platform for localized, topical delivery and proprietary liquid formulations designed to optimize local issue uptake. These candidates have the potential to improve efficacy, tolerability, and patient outcomes for inflammatory bowel disease – a $15 billion market. The two lead drug DDS combinations are PGN-600 (Tofacitinib + DDS) and PGN-001 (Adalimumab + DDS), with other candidates under consideration. In the first half of 2022, the company anticipates the initiation of the first clinical study evaluating a therapeutic delivered with DDS.
    • Continued development of oral biopharmaceuticals delivery system (OBDS) programs designed for optimized systemic uptake focusing on monoclonal biotherapeutics based on promising preclinical data. The lead drug-OBDS combinations, each with the potential to address markets in excess of $1 billion, are PGN-OB1 (oral Adalimumab) for the treatment of autoimmune disorders and PGN-OB2 (oral Liraglutide) for the treatment of type 2 diabetes and cardiovascular outcomes, with other monoclonal-based biotherapeutics under consideration.

    PreecludiaTM

    • Advancement of its PreecludiaTM preeclampsia rule-out test through validation and progressing physician education programs, clinical utility, health economics, and reimbursement. With topline validation anticipated in the June/July 2021 timeframe, the PreecludiaTM test is expected to target an addressable market of up to $3 billion in the U.S. alone. The PreecludiaTM test, in addition to the laboratory-developed test (LDT) immunodiagnostic, has potential as an in vitro diagnostic and point-of-care solution globally. The company is exploring partnerships for these options.

    Ongoing Development

    • Continued development of its ingestible lab-in-a-capsule technology (PIL Dx), initially focused on small intestinal bacterial overgrowth (SIBO), an estimated $36 billion U.S. market, and Recoverable Sample System (RSS) technologies. The RSS, when used in conjunction with targeted therapeutics, has the potential to enable the development of complementary and companion diagnostics. Key clinical milestones are expected in the next 2-3 quarters.
    • Continued development of its single-molecule detection platform, the first application of which is for noninvasive prenatal testing (NIPT), with future potential applications in oncology and GI disease in support of the RSS and PIL Dx technologies. The company is progressing towards achieving initial development milestones in the next two quarters.
    • The Path Forward. By focusing its business model, the company intends to more effectively allocate capital, reduce expenditures, and unlock the value of its highly differentiated R&D pipeline. Progenity's innovation pipeline has the potential to address markets collectively valued at greater than $200 billion. By progressively concentrating resources on the PreecludiaTM test, GI health, and oral biopharmaceuticals opportunities, Progenity hopes to unlock significant value for shareholders and improve patient outcomes.

    "The strategic transformation presented today seeks to significantly reduce our burn rate by eliminating major costs and reducing our cash needs considerably to a normalized rate of $4-5 million per month (before taking into account non-dilutive sources of capital). Our innovative R&D pipeline has always been core to our future growth plan and has the potential to transform and address significant markets by improving patient outcomes," said Harry Stylli, PhD, CEO, Chairman of the Board of Directors, and co-founder of Progenity. "Leading with innovation also enables Progenity to exercise greater control over our costs, as a significant proportion of the company's spend is discretionary and milestone driven. We believe that we can deploy capital more efficiently by focusing on the differentiated innovation assets in our portfolio that have the greatest potential to drive shareholder value and generate non-dilutive dollars through scalable partnerships."

    Stylli continued, "It is especially difficult to say goodbye to valued team members. We are grateful for their dedication and support over these past years. We also appreciate the healthcare providers, patients, and other stakeholders that have placed trust in us at critical life moments for more than a decade."

    As part of the strategic transformation, Progenity will continue to evaluate its operations to better position the business for future growth and continued innovation. In light of the impact of this strategic transformation, the company is withdrawing previously announced financial guidance for 2021.

    Webcast and Conference Call Information

    Progenity will host a webcast and conference call to discuss the strategic transformation and answer investment community questions today, Wednesday, June 2, 2021 at 8:30 a.m. ET / 5:30 a.m. PT. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 1285219. A live webcast and archive of the call will be available online on the investor relations section of the company website at www.progenity.com.

    About Progenity



    Progenity, Inc. is a biotechnology company innovating in the fields of gastrointestinal health and oral biotherapeutics. Progenity applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the Company's transformation activities and expected benefits and costs savings; potential benefits from a strategic and cost realignment, including potential future growth; potential future strategic transactions; potential addressable market sizes; our ability to deliver value for shareholders; the timing for future milestones, including the commencement of clinical trials and validation of Preecludia; the potential for our innovation pipeline; the development of our DDS and OBDS platforms; the potential benefits of the DDS and OBDS platforms; the development pipeline of therapeutic candidates that use the DDS and OBDS platforms; and the development of drug-device combination products, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including: whether we will realize anticipated benefits of our strategic transformation; whether we are able to develop any products that meet our desired target product profile and address the relevant clinical need or commercial opportunity; whether any products that we develop will prove to be effective in preclinical and/or clinical trials or otherwise; whether we will obtain necessary regulatory authorizations, in a timely manner or at all; competition from existing products or new products; the timing of regulatory review and our ability to obtain regulatory marketing authorizations of our product candidates; preclinical and/or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; the ongoing COVID-19 pandemic and associated shelter-in-place orders; the loss or retirement of key scientific or management personnel; and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294

     



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  15. SAN DIEGO, May 26, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced results from a further study for the company's Targeted Therapeutics program. The study evaluated delivery of Progenity's PGN-001 (adalimumab) drug substance directly to the colon in a preclinical model of colitis.

    Progenity's Targeted Therapeutics program consists of drug-device combination products under development that have the potential to deliver high concentrations of proprietary drug formulations via a novel, orally ingestible capsule to the precise site of disease along the gastrointestinal (GI) tract. The Drug Delivery System (DDS) capsule is designed to maximize the available dose at the site of disease…

    SAN DIEGO, May 26, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced results from a further study for the company's Targeted Therapeutics program. The study evaluated delivery of Progenity's PGN-001 (adalimumab) drug substance directly to the colon in a preclinical model of colitis.

    Progenity's Targeted Therapeutics program consists of drug-device combination products under development that have the potential to deliver high concentrations of proprietary drug formulations via a novel, orally ingestible capsule to the precise site of disease along the gastrointestinal (GI) tract. The Drug Delivery System (DDS) capsule is designed to maximize the available dose at the site of disease to potentially improve efficacy and reduce systemic toxicity.

    Progenity's lead Targeted Therapeutics product candidates, PGN-001 (liquid adalimumab delivered by DDS) and PGN-600 (liquid tofacitinib delivered by DDS), are being developed with an initial priority for ulcerative colitis, part of the estimated $15 billion inflammatory bowel disease market.

    The company completed a preclinical study evaluating the tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of adalimumab liquid formulation (PGN-001 drug substance) delivered directly to the colon through local administration to the cecum in a swine model of induced colitis. PGN-001 drug substance was delivered in either single administration or daily repeat administration for three days by a surgically implanted intracecal (IC) catheter as a surrogate for direct delivery to the colon by the DDS. The study included healthy and induced colitis vehicle control groups.

    The study found that adalimumab was detected in tissue along the length of the colon after IC administration. There was also a significant reduction in TNF-α, the proinflammatory cytokine target of adalimumab, at each of 24 and 48 hours following repeat IC doses when compared with the induced colitis control group that did not receive treatment. No treatment-related adverse events were observed and no measurable adalimumab was detected in the blood, in each case, for animals administered adalimumab by IC catheter.

    "These results suggest targeted topical delivery of adalimumab may provide an advantage over systemic delivery by substantially reducing the TNF-α burden within the colonic tissue with little to no systemic breakthrough. These results are made even more impressive as adalimumab has significantly lower affinity for pig TNF-α compared to human. Not only does this support the potential use of PGN-001 as monotherapy but also as combination therapy given the minimal systemic levels and associated safety margin," said William Sandborn, MD, Professor of Medicine at the University of California San Diego.

    This study builds upon data Progenity previously presented at Digestive Disease Week 2019 from a mouse model of colitis that used a species-appropriate TNF-α monoclonal antibody delivered by IC catheter. The 2019 study found that targeted IC delivery significantly reduced weight loss, decreased Disease Activity Index, improved histological score and reduced tissue inflammatory cytokines in mice when compared with vehicle controls. The 2021 study in swine models more closely represents human anatomy, allows for use of PGN-001 drug substance, and therefore provides more robust data for the potential effect in humans.

    "These preclinical results provide further evidence that therapies delivered locally in the GI tract have the potential to transform the treatment of ulcerative colitis by maximizing the available dose at the site of disease while reducing systemic exposure to improve safety. We now have evidence that this is not just the case for small molecules but also for monoclonal antibodies. This opens the potential for additional candidates for our Targeted Therapeutics program, as well as pharmaceutical and biotech partnerships," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity.

    The company is currently performing a clinical study to obtain further supporting data for the local delivery of adalimumab, using administration by enema as a surrogate for delivery with the DDS. Preliminary results are expected this year and should further guide dosing as Progenity advances towards clinical evaluation of adalimumab delivered by the DDS in ulcerative colitis patients.

    The Targeted Therapeutics program is further supported by additional data previously announced by Progenity:

    • Preclinical data presented at DDW 2021 demonstrating the functionality of the Drug Delivery System capsule, in which the DDS capsule successfully identified the colonic entry and delivered drugs to the colon after oral administration in fasted animal models.



    • Preclinical data presented at DDW 2021 indicating that targeted delivery of proprietary, soluble tofacitinib (PGN-600) to the site of inflammation has the potential to increase tissue absorption and coverage and reduce systemic toxicity.



    • Preclinical results showing that the DDS in combination with proprietary, soluble tofacitinib (PGN-600) achieved a greater than 25-fold increase in drug delivery to colon tissue vs. equivalent orally administered dose. PGN-600 also demonstrated reduced systemic breakthrough.



    • Clinical study results demonstrating that the DDS was able to target the colon and successfully release a liquid payload with pan-colonic distribution as observed by imaging, in normal healthy volunteers.  

    Progenity also recently announced funding from the Crohn's and Colitis Foundation to support the development and further clinical evaluation of the DDS.

    About Progenity



    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development our DDS platform, the potential benefits of the DDS platform, the development pipeline of therapeutic candidates that use the DDS, and the development of drug device combination products, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including: whether we are able to develop any products that meet our desired target product profile and address the relevant clinical need or commercial opportunity; whether any products that we develop will prove to be effective in preclinical and/or clinical trials or otherwise; whether we will obtain necessary regulatory authorizations, in a timely manner or at all; competition from existing products or new products; the timing of regulatory review and our ability to obtain regulatory marketing authorizations of our product candidates; preclinical and/or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; the ongoing COVID-19 pandemic and associated shelter-in-place orders; the loss or retirement of key scientific or management personnel; and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  16. SAN DIEGO, May 25, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced the appointment of Sean Lavin, M.D. as Vice President, Business Development, Strategy, and Investor Relations. In this advisory role, Dr. Lavin will work with Progenity's senior management in the areas of strategy, business development, investor outreach, and shareholder value creation as the company transitions its focus towards biotechnology innovation. Dr. Lavin previously served as a Managing Director in equity research at BTIG and Lazard Capital Markets where he covered medical devices and diagnostics, and he currently runs his own firm, Alpha Lavin Advisors, which focuses on value creation within these sectors…

    SAN DIEGO, May 25, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced the appointment of Sean Lavin, M.D. as Vice President, Business Development, Strategy, and Investor Relations. In this advisory role, Dr. Lavin will work with Progenity's senior management in the areas of strategy, business development, investor outreach, and shareholder value creation as the company transitions its focus towards biotechnology innovation. Dr. Lavin previously served as a Managing Director in equity research at BTIG and Lazard Capital Markets where he covered medical devices and diagnostics, and he currently runs his own firm, Alpha Lavin Advisors, which focuses on value creation within these sectors.

    "We are excited to welcome Sean," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "He is very well respected within the industry and by institutional investors, and he brings with him significant knowledge of our innovative products, growth strategies, and future technologies. I look forward to his contributions to Progenity, including the introduction of our new biotech offerings and strategy to the institutional investor community."

    Dr. Lavin joined Lazard Capital Markets in 2008 as the firm's senior medical technology and diagnostics analyst and then became the first senior healthcare analyst at BTIG in 2013. There, he supported the build-out of the healthcare team and helped BTIG become one of the most active banks involved in IPOs and secondary offerings between medical technology, diagnostic companies and institutional investor funds. Before coming to Wall Street, Dr. Lavin earned an M.D. degree from the Ohio State University College of Medicine and a B.S. degree from the Massachusetts Institute of Technology.

    "I believe Progenity is an innovative company with the potential to transition from a laboratory business to high growth biotech and molecular areas and greatly enhance shareholder value. The company's Preecludia™ rule-out test for preeclampsia has the potential to change prenatal care for many expectant mothers. Currently, many preeclamptic patients either must deliver early or be hospitalized, as there is no definitive test to help an obstetrician determine the risk that a woman and her baby will be impacted by preterm preeclampsia or whether it is safe to wait to deliver the child. The data recently presented at the ACOG Annual Meeting looked quite compelling, and I look forward to the launch of Preecludia," said Dr. Sean Lavin, Vice President, Business Development, Strategy, and Investor Relations at Progenity. "Progenity's targeted therapeutics program has the potential to change the treatment paradigm for inflammatory bowel and other diseases. The ability to precisely deliver very high dose anti-inflammatories, immunoglobins, or other drugs to a specific portion of the bowel and minimize systemic toxicities has the potential to change the practice of gastroenterology and other areas of medicine. It seems to be a very exciting time at Progenity, and I am pleased to be able to work with the senior team to help them increase investor awareness and build shareholder value."



    "Sean brings many relationships and deep insights to Progenity that have been developed over 15 years spent working with both large public healthcare companies and institutional funds from around the world," said Eric d'Esparbes, Progenity senior vice president and chief financial officer. "We are thrilled to welcome him to our team."

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the development of our DDS platform, the potential benefits of the DDS platform, the development pipeline of therapeutic candidates that use the DDS, and the development of drug device combination products, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including: whether we are able to develop any products that meet our desired target product profile and address the relevant clinical need or commercial opportunity; whether any products that we develop will prove to be effective in preclinical and/or clinical trials or otherwise; whether we will obtain necessary regulatory authorizations, in a timely manner or at all; competition from existing products or new products; the timing of regulatory review and our ability to obtain regulatory marketing authorizations of our product candidates; preclinical and/or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; the ongoing COVID-19 pandemic and associated shelter-in-place orders; the loss or retirement of key scientific or management personnel; and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  17. SAN DIEGO, May 24, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced the presentation of two posters related to the company's Targeted Therapeutics program presented at the 2021 Digestive Disease Week® (DDW) Virtual Event. The posters include a preclinical study evaluating treatment of intestinal inflammation with the Company's PGN-600 (liquid tofacitinib) product candidate and a second preclinical study of its investigational ingestible Drug Delivery System (DDS). DDW is the world's premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.

    "There remains a significant medical need for safe and…

    SAN DIEGO, May 24, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced the presentation of two posters related to the company's Targeted Therapeutics program presented at the 2021 Digestive Disease Week® (DDW) Virtual Event. The posters include a preclinical study evaluating treatment of intestinal inflammation with the Company's PGN-600 (liquid tofacitinib) product candidate and a second preclinical study of its investigational ingestible Drug Delivery System (DDS). DDW is the world's premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.

    "There remains a significant medical need for safe and effective targeted therapeutics to treat disorders such as ulcerative colitis and Crohn's disease. Targeted drug delivery directly to the colon has the potential to improve drug absorption at the site of inflammation, improving the efficacy of treatment," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "These preclinical studies together suggest how, by leveraging an investigational, proprietary soluble formulation of an approved compound, such as tofacitinib, our Drug Delivery System has the potential to address the unmet need of mucosal targeted therapy for inflammatory bowel disease."

    The presentation titled Targeted Delivery of Soluble Tofacitinib Citrate to the Site of Inflammation to Improve Efficacy and Safety studied the pharmacokinetic (PK), pharmacodynamic (PD), and biodistribution of tofacitinib liquid formulation (PGN-600) through local administration to the cecum in animal models. Tofacitinib was the first oral JAK inhibitor approved to treat moderate to severe ulcerative colitis.

    Targeted local delivery of drugs directly to the colon may increase local tissue concentration to improve efficacy and lower systemic absorption. To test this, animal models were implanted with a cecal cannula to study the direct delivery of drug compared to the oral delivery of tofacitinib citrate. The study found that:

    • Approximately 10- to 15-fold smaller doses of tofacitinib administered via intra-cecal delivery achieved equivalent drug concentrations with lower systemic drug exposure compared to oral delivery.
    • Intra-cecal delivery of tofacitinib to the inflamed mucosa potentiated PD activity at a lower dose.
    • Soluble tofacitinib formulation increased tissue absorption and coverage via intra-cecal administration.

    These results indicate that targeted delivery of soluble tofacitinib to the site of inflammation increased tissue absorption and coverage, suggesting the potential to achieve greater activity with a lower risk of systemic toxicity compared to oral delivery.

    In a poster presentation titled Development of a Novel Drug Delivery System for Targeted Treatment of Ulcerative Colitis, a preclinical proof-of-concept study was conducted to evaluate the functionality of the DDS after oral administration (PO) in fasted animal models. The DDS is an investigational ingestible electronic capsule that is designed to deliver therapeutic compounds to a defined location in the gastrointestinal tract. It is comprised of a drug reservoir containing a liquid formulation of the therapeutic compound, a removable cap, and an electronic module. In this preclinical study, two marker drugs, acetaminophen and sulfasalazine, were loaded into the capsule's drug reservoir. Acetaminophen absorption was utilized to evaluate drug release and sulfasalazine absorption was utilized to identify colon arrival.

    In this study, the PK results from both drugs showed that the DDS capsule autonomously identified the colonic entry and delivered the drugs to the colon successfully. The Company believes these results support the potential of the DDS to deliver mucosal targeted therapy for GI disorders such as inflammatory bowel disease (IBD).

    The study posters and findings are part of DDW's virtual sessions which can be accessed on demand until August 23, 2021. Details of the presentations are as follows:

    Presentation Title: Targeted Delivery of Soluble Tofacitinib Citrate to the Site of Inflammation to Improve Efficacy and Safety

    Authors: Shaoying Nikki Lee, PhD; Cheryl Stork, PhD; Chris Wahl, MD; Sharat Singh, PhD; Emil Chuang, MD

    Poster Number: #Fr488

    Presentation Title: Development of a Novel Drug Delivery System 2 (DDS2) for Colon Targeted Delivery Treatment of Ulcerative Colitis (UC)

    Authors: Shaoying Nikki Lee, PhD; Jeff Shimizu; Cheryl Stork, PhD; Nelson Quintana; Chris Wahl, MD; Sharat Singh, PhD; Emil Chuang, MD

    Poster Number: #Su599

    The poster presentations can also be reviewed now on the Progenity website.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development our DDS platform, the potential benefits of the DDS platform, the potential for targeted drug delivery directly to the colon to improve drug absorption at the site of inflammation and improve the efficacy of treatment, the potential of the DDS to address the unmet need of mucosal targeted therapy for IBD, the potential for targeted delivery of soluble tofacitinib to the site of inflammation to achieve greater activity with a lower risk of systemic toxicity compared to oral delivery, the development pipeline of therapeutic candidates that use the DDS, and the development of drug device combination products, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including: whether we are able to develop any products that meet our desired target product profile and address the relevant clinical need or commercial opportunity; whether any products that we develop will prove to be effective in preclinical and/or clinical trials or otherwise; whether we will obtain necessary regulatory authorizations, in a timely manner or at all; competition from existing products or new products; the timing of regulatory review and our ability to obtain regulatory marketing authorizations of our product candidates; preclinical and/or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; the ongoing COVID-19 pandemic and associated shelter-in-place orders; the loss or retirement of key scientific or management personnel; and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619)743-6294



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  18. SAN DIEGO, May 21, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products in women's health, joins the global call to raise awareness of preeclampsia in pregnancy on World Preeclampsia Day, on Saturday, May 22. Preeclampsia is a hypertensive disorder that strikes during pregnancy and is the number two cause of maternal mortality. However, data from a recent survey of women of childbearing age showed less than half know that high blood pressure is the most common sign of preeclampsia. This points to the urgent need for further patient awareness and education around the symptoms of preeclampsia.

    In honor of World Preeclampsia…

    SAN DIEGO, May 21, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products in women's health, joins the global call to raise awareness of preeclampsia in pregnancy on World Preeclampsia Day, on Saturday, May 22. Preeclampsia is a hypertensive disorder that strikes during pregnancy and is the number two cause of maternal mortality. However, data from a recent survey of women of childbearing age showed less than half know that high blood pressure is the most common sign of preeclampsia. This points to the urgent need for further patient awareness and education around the symptoms of preeclampsia.

    In honor of World Preeclampsia Day, Progenity has created two free resources to help support the important conversations between patients and physicians about the symptoms of preeclampsia. "Talking with Patients about Preeclampsia" is a fact sheet for healthcare providers that gives suggestions on how to start a conversation with patients about preeclampsia, while also addressing potential anxiety. The fact sheet for patients, "Understanding Preeclampsia: Questions to Ask Your OB/GYN," is designed to empower patients to recognize symptoms and engage in a conversation with their doctor as their own best advocate.

    Preeclampsia is often missed or misdiagnosed because the symptoms are very common – appearing in nearly 30% of all pregnant women in the United States – and can easily be attributed to other causes. This makes it difficult for doctors to differentiate which patients may be developing preeclampsia.

    Despite the increasing rates of preeclampsia, there have been no significant advancements in diagnostic assessment tools in the United States in decades. However, doctors may soon have a new tool—a simple blood test to rule out the risk of preeclampsia for up to 14 days, modernizing the way they evaluate patients. The Preecludia™ test, in late stage development by Progenity, is designed to help physicians differentiate symptomatic patients who are at reduced risk for preeclampsia from those who are at risk.

    "We are pleased to play a role in educating both physicians and patients about how to best discuss the signs and symptoms of preeclampsia. We feel this is part of our responsibility as an innovator in the area of preeclampsia diagnostics," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "The Preecludia test would be the first of its kind in the United States and is designed to help improve the assessment and management of preeclampsia. We look forward to continuing our commitment to preeclampsia education as we move toward our targeted launch later this year."

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Preecludia

    Progenity's preeclampsia rule-out test, Preecludia, has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is run from a simple blood draw and is designed to address the unmet need for tools to aid in the assessment and management of preeclampsia. Positive performance data from the Preecludia verification study were presented April 30th at the American College of Obstetricians and Gynecologists (ACOG) Annual Meeting. The test is now in the final clinical validation testing phase, with a targeted launch expected in the second half of 2021.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the development progress of our preeclampsia rule-out test, and its future use by providers to rule out preeclampsia, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including acceptance and clinical utility of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC, including but not limited to Quarterly Reports on Form 10-Q. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    IR@progenity.com

    (619) 228-5886

    Media Contact:

    Angela Salerno-Robin

    dna Communications

    ASalerno-Robin@dna-comms.com   

    (212) 445-8219



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  19. Reports revenues of $24.5 million in the first quarter of 2021, up 72% from prior quarter

    Announced pre-validation data for its Preecludia™ test showed strong performance consistent with verification study and demonstrated commercial laboratory systems readiness

    Announced funding from the Crohn's and Colitis Foundation's IBD Ventures program to further develop Progenity's first-in-class oral DDS for delivery of targeted therapeutics for IBD

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, May 13, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products…

    Reports revenues of $24.5 million in the first quarter of 2021, up 72% from prior quarter

    Announced pre-validation data for its Preecludia™ test showed strong performance consistent with verification study and demonstrated commercial laboratory systems readiness

    Announced funding from the Crohn's and Colitis Foundation's IBD Ventures program to further develop Progenity's first-in-class oral DDS for delivery of targeted therapeutics for IBD

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, May 13, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided a corporate update and reported financial results for the first quarter ended March 31, 2021.

    Progenity made significant progress during the first quarter, both with its core molecular testing business and notably with its innovation pipeline programs. The Company recently announced another key update regarding its Preecludia™ preeclampsia rule-out test, reporting that new data from a pre-validation cohort of samples tested to demonstrate commercial laboratory readiness showed test performance in the intended use population consistent with its verification study results that were presented on April 30th at the 2021 ACOG Annual Meeting. This new data showed sensitivity greater than 87% and a negative predictive value (NPV) greater than 97%. The Company continued to transition its core molecular testing business towards growth, increased its in-network position by adding regional contracts, and saw additional commercial and government payors covering average risk NIPT.

    "We continue to make strong progress in our innovation pipeline as we establish a strong foundation and stabilize our core molecular testing business. We anticipate these efforts will translate into improved operating performance and revenue growth for the rest of 2021. We are on track to meet our Preecludia™ test's validation milestone by mid-year and continue to target commercial launch in the second half of 2021 for the $2-3 billion US market, the Innatal 4 platform is advancing; and we are especially excited by the accelerating progress of our GI Precision Medicine programs," said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity.

    First Quarter 2021 Results and Other Corporate Highlights

    • Announced and presented new data from its Preecludia™ preeclampsia rule-out test verification study which was presented on April 30th at the 2021 ACOG Annual Meeting, with the test demonstrating sensitivity of 87.8% and a negative predictive value (NPV) of 97.0%.



    • Announced pre-validation data for its Preecludia™ test showed strong performance consistent with verification study data and demonstrated commercial laboratory systems readiness.



    • Announced completion of assay testing and initiation of data analysis of clinical validation study samples for its Preecludia™ preeclampsia test.



    • Entered into an agreement with Ionis Pharmaceuticals, a leader in RNA-targeted therapeutics, to evaluate the safety, tolerability and performance of Progenity's Oral Biotherapeutics Delivery System (OBDS) for oral systemic delivery of antisense oligonucleotides, developed and manufactured by Ionis.



    • Announced Crohn's & Colitis Foundation IBD Ventures grant funding for DDS combination drug/device product development for IBD diseases.



    • Announced that two abstracts related to Progenity's ingestible drug delivery technologies for the treatment of gastrointestinal disorders have been accepted for presentation at Digestive Disease Week® (DDW) taking place May 21-23, 2021.



    • Announced first clinical study of the Company's oral drug delivery system (DDS) demonstrating a proprietary autonomous localization technology designed to auto-locate and deliver a payload in a key region of the GI tract for drug delivery. Also announced a preclinical safety and tolerability study of PGN-600, a combination product of tofacitinib delivered by DDS.



    • In February 2021, raised approximately $25.0 million in gross proceeds from a private placement with two leading healthcare-focused investment funds.



    • Increased in-network covered lives by 3.3 million with the addition of several regional plans.

    First Quarter 2020 Financial Results

    Comparison of Three Months Ended March 31, 2021 and December 31, 2020

    Revenue was $24.5 million in the three months ended March 31, 2021, a 72% increase compared to $14.3 million in the three months ended December 31, 2020.

    Total accessioned tests volume, which includes the company's core molecular testing and COVID-19 testing, was 78,915 in the first quarter of 2021, a decrease of 3.3% compared to accessioned tests volume in the fourth quarter of 2020, which was 81,640 tests.

    Gross margin was positive 9.4% for the three months ended March 31, 2021, compared to negative 50.1% for the three months ended December 31, 2020.

    Operating expenses were $48.5 million for the three months ended March 31, 2021, compared to $44.2 million for the three months ended December 31, 2020.

    Net loss was $32.3 million for the three months ended March 31, 2021 and basic and diluted net loss per share was $0.56, compared to a net loss of $75.5 million and a net loss per share of $1.53 for the three months ended December 31, 2020.

    Comparison of Three Months Ended March 31, 2021 and 2020

    Revenue was $24.5 million in the three months ended March 31, 2021, a 46% increase compared to $16.8 million in the three months ended March 31, 2020.

    Gross margin was positive 9.4% for the three months ended March 31, 2021, compared to negative 57.9% for the three months ended March 31, 2020.

    Operating expenses were $48.5 million for the three months ended March 31, 2021, compared to $42.8 million in the three months ended March 31, 2020.

    Net loss was $32.3 million for the three months ended March 31, 2021 and basic and diluted net loss per share was $0.56, compared to a net loss of $17.2 million and a net loss per share of $3.43 for the three months ended March 31, 2020.

    COVID-19 Update

    Public health measures related to the novel coronavirus are greatly impacting healthcare practices. We have responded to the COVID-19 pandemic by implementing and maintaining robust response plans, seamlessly continuing laboratory operations and maintaining pre-pandemic turnaround times. We enhanced our digital sales and support capabilities, increased proactive test reporting and remote genetic counseling capabilities, and expanded our mobile phlebotomy services, assisting our customers to continue serving their patients with the same quality care.

    Webcast and Conference Call Information

    Progenity will host a webcast and conference call to discuss the first quarter financial results and answer investment community questions today, Thursday, May 13, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 6146238. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the impact of the COVID-19 pandemic on our business, operations, financial results, and future performance, and the progress of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to develop and commercialize our testing products, our ability to innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding future test volumes and revenues, our expectations regarding our in network position, anticipated capacity for our tests, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the period ended December 31, 2020 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.

    Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436



    Progenity, Inc. 

    Condensed Consolidated Statements of Operations 

    (Unaudited) 

    (In thousands, except share and per share amounts)

      Three Months Ended 
      March 31,

    2021
      December 31,

    2020
     
    Revenues (1) $24,526  $14,276 
    Cost of sales  22,234   21,427 
    Gross profit (loss)  2,292   (7,151)
    Operating expenses:        
    Research and development  11,673   11,226 
    Selling and marketing  14,648   12,471 
    General and administrative  22,219   20,523 
    Total operating expenses  48,540   44,220 
    Loss from operations  (46,248)  (51,371)
    Interest and other expense, net  (3,520)  (2,699)
    Gain on warrant liability  2,650    
    Interest and other income (expense), net  14,854   (21,294)
    Loss before income taxes  (32,264)  (75,364)
    Income tax expense     164 
    Net loss $(32,264) $(75,528)
    Net loss per share, basic and diluted $(0.56) $(1.53)
    Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted  57,493,800   49,288,579 

    ________________

    (1) Revenues for the three months ended March 31, 2021 and December 31, 2020 reflect an accrual of $188 thousand and $10.7 million, respectively, recorded as a reserve for potential payor settlements.





    Progenity, Inc. 

    Condensed Consolidated Statements of Operations 

    (Unaudited) 

    (In thousands, except share and per share amounts)

      Three Months Ended

    March 31,
     
      2021  2020 
             
    Revenues (1) $24,526  $16,828 
    Cost of Sales  22,234   26,570 
    Gross profit (loss)  2,292   (9,742)
    Operating Expenses:        
    Research and development  11,673   11,240 
    Selling and marketing  14,648   14,436 
    General and administrative  22,219   17,108 
    Total operating expenses  48,540   42,784 
    Loss from operations  (46,248)  (52,526)
    Interest expense  (3,520)  (2,302)
    Gain on warrant liability  2,650    
    Interest and other income (expense), net  14,854   (20)
    Loss before income taxes  (32,264)  (54,848)
    Income tax expense (benefit)     (37,696)
    Net loss $(32,264) $(17,152)
    Net loss per share, basic and diluted $(0.56) $(3.43)
    Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted  57,493,800   4,993,393 

    _____________

    (1) Revenues for the three months ended March 31, 2021 reflect an accrual of $188 thousand recorded as a reserve for potential payor settlements. Revenues for the three months ended March 31, 2020 reflect an accrual of $13.2 million related to the settlement with the DOJ and the participating State AGs.





    Progenity, Inc. 

    Condensed Consolidated Balance Sheets 

    (Unaudited) 

    (In thousands)

      March 31,

    2021
      December 31,

    2020
     
          (1) 
    Assets        
    Current assets:        
    Cash and cash equivalents $65,276  $92,076 
    Accounts receivable, net  13,206   12,682 
    Inventory  12,377   12,219 
    Prepaid expenses and other current assets  10,312   9,361 
    Total current assets  101,171   126,338 
    Property and equipment, net  17,377   17,842 
    Goodwill and other intangible assets  9,830   10,062 
    Other assets  199   198 
    Total assets $128,577  $154,440 
    Liabilities and Stockholders' Deficit        
    Current liabilities:        
    Accounts payable $15,625  $17,410 
    Accrued expenses and other current liabilities  53,783   54,677 
    Warrant liability  10,154    
    Current portion of mortgages payable and capital lease obligations  500   583 
    Total current liabilities  80,062   72,670 
    Mortgages payable and capital lease obligations, net of current portion  2,741   2,841 
    Convertible notes, net  159,204   158,886 
    Embedded derivative liability  3,542   18,370 
    Other long-term liabilities  8,535   8,667 
    Total liabilities $254,084  $261,434 
    Stockholders' deficit:        
    Common stock  63   59 
    Additional paid-in capital  466,740   452,992 
    Accumulated deficit  (573,538)  (541,274)
    Treasury stock  (18,772)  (18,771)
    Total stockholders' deficit  (125,507)  (106,994)
         Total liabilities and stockholders' deficit $128,577  $154,440 

    ______________

    (1) The condensed consolidated balance sheet data at December 31, 2020 has been derived from the audited consolidated financial statements





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  20. SAN DIEGO, May 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced preliminary results, subject to final audited study reports by its contract research organization (CRO), from two key studies for the Company's Targeted Therapeutics program. The studies involved both the first functional clinical study of the Drug Delivery System (DDS), and the first preclinical study of PGN-600 (liquid tofacitinib delivered by DDS), one of the Company's drug/DDS combination products.

    Progenity's Targeted Therapeutics program consists of drug device combination products that allow the delivery of high concentrations of proprietary drug formulations by a novel, orally ingestible capsule to the precise…

    SAN DIEGO, May 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), an innovative biotechnology company, today announced preliminary results, subject to final audited study reports by its contract research organization (CRO), from two key studies for the Company's Targeted Therapeutics program. The studies involved both the first functional clinical study of the Drug Delivery System (DDS), and the first preclinical study of PGN-600 (liquid tofacitinib delivered by DDS), one of the Company's drug/DDS combination products.

    Progenity's Targeted Therapeutics program consists of drug device combination products that allow the delivery of high concentrations of proprietary drug formulations by a novel, orally ingestible capsule to the precise site of disease along the GI tract. The DDS capsule is designed to maximize the available dose at the site of disease and reduce systemic toxicity. The Company's two lead combination product candidates, PGN-001 (liquid adalimumab delivered by DDS) and PGN-600, are being developed with an initial priority for ulcerative colitis, part of the estimated $15 billion inflammatory bowel disease (IBD) market.

    The company has completed its first clinical study of the fully autonomous DDS device in twelve healthy adults. This study evaluated the capsule's targeting, safety and tolerability within the gastrointestinal tract and collected the first clinical data on the ability of the DDS to auto-locate and accurately deliver a payload to the proximal colon, a key delivery site for the treatment of ulcerative colitis and Crohn's disease. The single administration study used the well-established method of scintigraphic characterization to validate the DDS localization and the drug delivery mechanism by using a saline solution payload that included radioisotopes. Initial analysis of the study results suggests the DDS was well tolerated and the majority of DDS devices functioned as intended and could accurately identify entry into the colon, trigger release of a liquid payload, and achieve pan-colon distribution.

    "These results support the use of the DDS for the company's lead ulcerative colitis combination product candidate, and potentially for uses of the DDS with other therapeutics to create combination products targeting other GI diseases. By delivering solubilized therapeutics directly to the site of disease in the GI tract, the DDS can potentially improve efficacy through increased localized drug concentration while minimizing harmful side effects associated with systemic drug delivery," said William Sandborn MD, Professor of Medicine at the University of California San Diego.

    Progenity also completed a preclinical study evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic effects of a seven-day administration of PGN-600 (liquid tofacitinib delivered by DDS) at doses of 10mg or 25mg per day, with direct comparison to a standard orally administered tofacitinib tablet at 10mg per day in 12 canines. This was the first study evaluating PGN-600 as a combination product of the company's proprietary solubilized formulation of tofacitinib delivered with the DDS. Initial analysis of the study results suggests PGN-600 was well tolerated, the DDS functioned as intended in the majority of doses, and resulted in significantly higher tofacitinib concentrations in colon tissue, while also showing much lower systemic blood concentrations than the equivalent 10mg dose delivered by standard oral tablet. Tissue levels and tissue to plasma ratios of tofacitinib levels along the length of the colon were at least 25x and 50x higher respectively with PGN-600 at 10mg and 25mg daily compared to the standard oral tablet formulation of 10mg. These results demonstrate that the proprietary liquid formulation of PGN-600 can achieve pan-colonic distribution and facilitate mucosal penetration. In addition, no evidence of tissue damage was observed by histology at either 10mg or 25mg of PGN-600. The results of this study should help inform the clinical dosing of PGN-600, with data suggesting that a dose lower than currently commercially available tofacitinib formulations may lead to significantly greater tissue drug concentrations and materially reduced systemic exposure, potentially resulting in enhanced efficacy and lower systemic side effects.

    "The data from these two studies when considered together provide further evidence that local delivery of solubilized therapeutics using Progenity's proprietary liquid formulations to the site of disease is enabled by the DDS and may lead to improved pharmacokinetic and pharmacodynamic effects as compared to systemic administration," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "This approach has the potential to enhance any compatible drug and holds promise for monoclonal biotherapeutics such as adalimumab. Given these results, we are proceeding with activities to enable clinical evaluation of both tofacitinib and adalimumab drug candidates (PGN-001 and PGN-600) with the ultimate goal of significantly improving treatment outcomes for patients suffering from ulcerative colitis and Crohn's disease."   

    About Progenity



    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development our DDS platform, the potential benefits of the DDS platform, and the development pipeline of therapeutic candidates that use the DDS, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including: whether we are able to develop any products that meet our desired target product profile and address the relevant clinical need or commercial opportunity; whether any products that we develop will prove to be effective in clinical trials or otherwise; whether we will obtain necessary regulatory authorizations, in a timely manner or at all; competition from existing products or new products; the timing of regulatory review and our ability to obtain regulatory marketing authorizations of our product candidates; clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; the ongoing COVID-19 pandemic and associated shelter-in-place orders; the loss or retirement of key scientific or management personnel; and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  21. SAN DIEGO, May 11, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products, announced today that it has received funding from the Crohn's & Colitis Foundation's IBD Ventures program to further develop Progenity's first-in-class oral Drug Delivery System (DDS) for delivery of targeted therapeutics for inflammatory bowel disease (IBD).

    The DDS capsule is an orally ingestible and self-guided drug delivery device under development, which is designed to deliver doses of therapeutic compounds formulated in proprietary solutions to a defined location within the gastrointestinal (GI) tract.

    Current drug treatments for IBD…

    SAN DIEGO, May 11, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products, announced today that it has received funding from the Crohn's & Colitis Foundation's IBD Ventures program to further develop Progenity's first-in-class oral Drug Delivery System (DDS) for delivery of targeted therapeutics for inflammatory bowel disease (IBD).

    The DDS capsule is an orally ingestible and self-guided drug delivery device under development, which is designed to deliver doses of therapeutic compounds formulated in proprietary solutions to a defined location within the gastrointestinal (GI) tract.

    Current drug treatments for IBD suffer from less than optimal efficacies at safe doses, leading to a loss of response in many patients within the first few years of treatment. The DDS could improve efficacy of treatment through increased localized drug concentration, while potentially minimizing harmful side effects associated with systemic drug delivery. The promise of an improved therapeutic-safety index also creates the potential for targeted delivery of combination therapies.

    Funding from IBD Ventures will support further development and clinical studies of the DDS technology. Progenity is also developing a pipeline of therapeutic candidates that use the DDS to deliver proprietary soluble liquid formulations, designed to improve tissue uptake, directly to the colon to treat ulcerative colitis. Progenity's lead candidates include PGN-001, a high-concentration formulation of adalimumab, and PGN-600, a high concentration, solubilized formulation of tofacitinib. Progenity also plans to use the platform to develop solutions for Crohn's disease and other GI diseases in the future.

    IBD Ventures was developed by the Crohn's & Colitis Foundation to accelerate research and development of products that aim to improve the quality of life for patients with IBD. During 2020, less than 5% of applicants received funding, demonstrating the selectivity of the program.

    "We are proud to have been chosen by the Crohn's & Colitis Foundation to receive funding through their IBD Ventures program. This partnership will help support the development of our innovative DDS platform for IBD," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "We believe our therapeutic pipeline candidates, coupled with the DDS technology, could improve patient outcomes by delivering higher drug concentrations at the site of disease to improve efficacy, while limiting systemic uptake to ensure safety."

    "This type of innovative technology is well aligned with the Crohn's & Colitis Foundation's mission to improve the quality of life for the millions of Americans living with IBD, and we are pleased to support Progenity's work through our IBD Ventures program," said Dr. Caren Heller, Chief Scientific Officer for the Crohn's & Colitis Foundation.

    About the Crohn's & Colitis Foundation

    The Crohn's & Colitis Foundation is the leading non-profit organization focused on both research and patient support for inflammatory bowel disease (IBD). The Foundation's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life for the millions of Americans living with IBD. Our work is dramatically accelerating the research process through our investment initiatives; we also provide extensive educational resources for patients and their families, medical professionals, and the public. For more information, visit www.crohnscolitisfoundation.org, call 888-694-8872, or email info@crohnscolitisfoundation.org.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development our DDS platform, the potential benefits of the DDS platform, the use of proceeds of the IBD Ventures program funding and the development pipeline of therapeutic candidates that use the DDS. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the loss or retirement of key scientific or management personnel, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contacts:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294

    Rebecca Kaplan

    Crohn's & Colitis Foundation

    rkaplan@crohnscolitisfoundation.org

    201-707-6633



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  22. SAN DIEGO, May 06, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report first quarter 2021 financial results on Thursday, May 13, 2021 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers or 914-800-3810 for international callers, and entering the conference code: 6146238. A live webcast and archive of the call will be available online from the investor…

    SAN DIEGO, May 06, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report first quarter 2021 financial results on Thursday, May 13, 2021 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers or 914-800-3810 for international callers, and entering the conference code: 6146238. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  23. SAN DIEGO, May 05, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced another key update regarding its Preecludia preeclampsia rule-out test. The company reported that its systems and processes necessary for commercial launch, including information systems, laboratory equipment, SOP finalization, and laboratory personnel training, all demonstrated commercial readiness as part of a pre-validation test. Additionally, data from this new, independent, prospective, naïve cohort examined as part of the pre-validation process showed test performance in the intended use population that was consistent…

    SAN DIEGO, May 05, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced another key update regarding its Preecludia preeclampsia rule-out test. The company reported that its systems and processes necessary for commercial launch, including information systems, laboratory equipment, SOP finalization, and laboratory personnel training, all demonstrated commercial readiness as part of a pre-validation test. Additionally, data from this new, independent, prospective, naïve cohort examined as part of the pre-validation process showed test performance in the intended use population that was consistent with the verification study results presented April 30th at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting. The company recently announced it is in the clinical validation testing phase for the Preecludia test, with a targeted commercial launch expected in the second half of 2021.

    Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 women presenting each year with signs and symptoms of possible preeclampsia. It is characterized as a hypertensive disorder, but it is often difficult to clinically differentiate from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Ultimately, left undiagnosed and improperly managed, preeclampsia can result in impaired organ function, seizures, stroke, and death in the mother, and may require pre-term delivery of the baby. Preeclampsia can result in both poor health outcomes and significant costs.

    The new data, generated with the original locked algorithm from the verification study, came from a cohort of more than 300 blinded samples equally distributed across gestational ages collected during the PRO-104 protocol, and examined as part of the pre-validation process. Analysis of these samples from the intended use population showed test performance consistent with the Preecludia verification study, indicating further de-risking of the program. The pre-validation test performance showed sensitivity greater than 87% and a negative predictive value (NPV) greater than 97% at a prevalence of 11%, and a rule out window of up to 14 days from sample collection. A similar level of performance, if observed in the larger PRO-104 validation study, would provide clinicians, especially OB/GYNs, with a new tool for their assessment of women at risk for preeclampsia. Preecludia is expected to result in a materially superior approach to the existing standard of care which offers an NPV of 83%, at best.

    "We are very encouraged by the performance of the Preecludia test as evidenced in these data and prior studies. This portends well for the future performance of Preecludia in our validation study and for when we reach the commercial market," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "We have completed analytical testing and are initiating data analysis of the full set of patient samples from our validation study with over 1,300 patients. We plan to share the performance data from this validation study within the June/July timeframe. With these data in hand, we plan to begin a targeted launch of Preecludia in the second half of 2021 by leveraging our existing OBGYN/MFM channel."

    Progenity's Preecludia is a preeclampsia rule-out test, not a diagnostic predictive test for preeclampsia. It has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is run from a simple blood draw and is designed to address the unmet need for tools to aid in the assessment and management of preeclampsia. The US market opportunity for Preecludia is estimated at up to $3 billion, with additional global market opportunities.

    The ACOG poster presentation of the verification study results is available on the Progenity website.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the development progress of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the performance of the rule-out test in an upcoming validation study, the completion of our upcoming validation study, and our efforts and intent to commercialize the Preecludia test and address an unmet medical need, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including our ability to develop and commercialize our testing products, the size and growth potential of the markets for our products and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, the development, regulatory approval, efficacy, and commercialization of competing products, the loss or retirement of key scientific or management personnel, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others, the ongoing COVID-19 pandemic and associated impact on our business, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Angela Salerno-Robin

    dna Communications

    ASalerno-Robin@dna-comms.com

    (212) 445-8219



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  24. Progenity survey shows more women know their baby's "fruit size" than the key indicator of a common pregnancy complication

    Preeclampsia Awareness Month aims to educate women about the potentially deadly condition and recent advancements in diagnostic risk assessment

    SAN DIEGO, May 04, 2021 (GLOBE NEWSWIRE) -- May is Preeclampsia Awareness Month, and a recent survey is underscoring a stark need for more education around the second-most common cause of maternal mortality in the United States. The survey of nearly 800 women, including expectant mothers, new mothers within the last year, and those who are considering pregnancy, was conducted by Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success…

    Progenity survey shows more women know their baby's "fruit size" than the key indicator of a common pregnancy complication

    Preeclampsia Awareness Month aims to educate women about the potentially deadly condition and recent advancements in diagnostic risk assessment

    SAN DIEGO, May 04, 2021 (GLOBE NEWSWIRE) -- May is Preeclampsia Awareness Month, and a recent survey is underscoring a stark need for more education around the second-most common cause of maternal mortality in the United States. The survey of nearly 800 women, including expectant mothers, new mothers within the last year, and those who are considering pregnancy, was conducted by Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products in women's health. The results showed less than half of respondents know that high blood pressure, the main sign of preeclampsia, is a key indicator of the condition. In contrast, more than 50 percent of respondents know the "fruit size" of a baby at 12 weeks, a popular milestone marker for moms-to-be. This survey points to the need for further patient awareness and education around the symptoms of preeclampsia, a potentially dangerous complication of pregnancy.

    Nearly 30% of pregnant women in the United States experience signs and symptoms of possible preeclampsia, a condition that can occur during pregnancy or up to six weeks after. The condition is often missed or misdiagnosed because the symptoms are common and non-specific, making it difficult for doctors to clinically distinguish between those most at risk and those at a reduced risk. If undiagnosed or poorly managed, the condition can result in impaired organ function, seizures, stroke, and even death in the infant or mother, and may require pre-term delivery. In fact, approximately 5-8% of all pregnancies are complicated by preeclampsia.

    "Early recognition of preeclampsia can save lives," said Eleni Tsigas, CEO of the Preeclampsia Foundation. "This survey shows us how much work still needs to be done to educate pregnant women about the signs and symptoms of this devastating condition. All women need to know their risk for preeclampsia because timely diagnosis and management is critical."

    It can be difficult to evaluate suspected preeclampsia because there are more than a dozen signs and symptoms that can differ from woman to woman. The two main signs—high blood pressure and protein in the urine—typically aren't noticed without a visit to the doctor. Additionally, risk factors vary, and include common features such as first pregnancy, obesity, diabetes, maternal age younger than 18 or older than 35, and family history of preeclampsia. Black women are also at higher risk, and new research points to an increase in preeclampsia and preterm birth in women diagnosed with COVID-19.

    "I wish I would have known what preeclampsia is, what the symptoms are, and the impact that it could have on my son's life and mine. Instead, I found out about preeclampsia through surviving it and delivering my son early at 28 weeks," said preeclampsia survivor, Jasmine Mago. "Now I live to raise awareness, provide education, and support research in hope that mortality rates will decrease and that there will be more progress in treatment and diagnosis."

    Despite the increasing rates of preeclampsia, there have been no significant advancements in diagnostic assessment tools in the United States in decades. However, doctors may soon have a reliable way to rule out the risk of preeclampsia for up to 14 days, modernizing the way they evaluate patients. Developed by Progenity, a proprietary lab test—called Preecludia—could potentially be a tool to help providers differentiate patients with symptoms who are not at risk for preeclampsia from those who may be at increased risk. The test is designed to be run from a simple blood draw.

    "There's a clear unmet need for additional tools to help rule out possible preeclampsia in expectant mothers, and I know this first-hand after almost losing my wife to preeclampsia after a missed diagnosis," said Matthew Cooper, Ph.D., Chief Scientific Officer, Progenity. "The Preecludia test would be the first of its kind in the United States and would help to fill a gap in the assessment and management of preeclampsia. We look forward to offering the test to physicians and patients to make a real difference in the lives of mothers and babies."

    For more information about preeclampsia and how to recognize its signs and symptoms, visit the Preeclampsia Foundation.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Preecludia

    Progenity's preeclampsia rule-out test, Preecludia, has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is run from a simple blood draw and is designed to address the unmet need for tools to aid in the assessment and management of preeclampsia. Positive performance data from the Preecludia verification study were presented April 30th at the American College of Obstetricians and Gynecologists (ACOG) Annual Meeting. The test is now in the final clinical validation testing phase, with a targeted launch expected in the second half of 2021   

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit progenity.com.

    About the Preeclampsia Foundation

    The Preeclampsia Foundation is a U.S.-based 501(c)(3) not-for-profit organization established in 2000. Its purpose is to improve the outcomes of hypertensive disorders of pregnancy by educating, supporting and engaging the community, improving healthcare practices, and finding a cure. The Preeclampsia Foundation envisions a world where hypertensive disorders of pregnancy no longer threaten the lives of mothers and their babies. For more information, visit www.preeclampsia.org.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the development progress of our preeclampsia rule-out test, and its future use by providers to rule out preeclampsia, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including acceptance and clinical utility of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    IR@progenity.com

    (619) 228-5886

    Media Contact:

    Angela Salerno-Robin

    dna Communications

    ASalerno-Robin@dna-comms.com

    (212) 445-8219



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  25. SAN DIEGO, April 30, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced new data from its Preecludia preeclampsia rule-out test verification study are being presented today at the 2021 ACOG Annual Meeting, with the test demonstrating sensitivity of 87.8% and a negative predictive value (NPV) of 97.0%. The company recently announced it is in the clinical validation testing phase of Preecludia, with a targeted launch expected in the second half of 2021.

    Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 women presenting each year with signs and symptoms…

    SAN DIEGO, April 30, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced new data from its Preecludia preeclampsia rule-out test verification study are being presented today at the 2021 ACOG Annual Meeting, with the test demonstrating sensitivity of 87.8% and a negative predictive value (NPV) of 97.0%. The company recently announced it is in the clinical validation testing phase of Preecludia, with a targeted launch expected in the second half of 2021.

    Preeclampsia is the second most common cause of maternal mortality, with more than 700,000 women presenting each year with signs and symptoms of possible preeclampsia. It is characterized as a hypertensive disorder, but it is often difficult to clinically differentiate it from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Ultimately, if left undiagnosed and improperly managed, preeclampsia can result in impaired organ function, seizures, stroke, and death in the mother, and may require pre-term delivery of the baby. Preeclampsia can result in both poor health outcomes and significant costs.

    In the verification study being presented at ACOG today, blinded, naïve samples from twenty-four U.S. sites were tested to determine the performance of Preecludia to assess the risk of preeclampsia within fourteen days of sample collection. The samples were representative of a diverse U.S. population. Preecludia test performance, based on 303 subjects, showed 87.8% sensitivity and 97.0% NPV. These data point to the value of the test in assisting physicians to rule out patients at risk for preterm preeclampsia. By so doing, the test may provide reassurance to physicians and patients, and assist physicians in making better informed management and treatment decisions, potentially reducing overuse of interventions and resultant complications.

    "These data and prior studies are strong indicators of the future performance of the Preecludia test, and we are honored to present them at ACOG," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "They are also particularly timely as we mark Preeclampsia Awareness Month in May. We have initiated analysis of our PRO-104 validation study patient samples and plan to share the performance data, established with samples from over 1,300 patients, in the June/July timeframe. We expect to bring our Preecludia test to market soon thereafter, to finally provide doctors and expectant women with a unique, modern solution for improving preeclampsia risk assessment."

    Preecludia has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is run from a simple blood draw and is designed to address the unmet need for tools to aid in the assessment and management of preeclampsia. The U.S. market opportunity is for Preecludia is estimated at up to $3 billion, with additional global market opportunities.

    The data presented at ACOG are part of the virtual meeting's interactive ePosters. Details of the presentation are as follows:

    Title – Performance of a novel multi-biomarker rule out preeclampsia test: a prospective verification study

    Authors – Matthew Cooper, PhD, DABT, MBA; Amin Mazloom, PhD; Chelsea Obrochta, PhD(c); Ronald Wapner, MD; Todd Rosen, MD; Allan Bombard, MD

    Poster number 999251

    The poster presentation will also be made available on the Progenity website following the conference.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the development progress of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the performance of the rule-out test in an upcoming validation study, the completion of our upcoming validation study, and our efforts and intent to commercialize the Preecludia test and address an unmet medical need, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including our ability to develop and commercialize our testing products, the size and growth potential of the markets for our products, and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, the fact that the data presented relates to the verification stage and may not be predicative of future results, including those from the validation stage, the development, regulatory approval, efficacy, and commercialization of competing products, the loss or retirement of key scientific or management personnel, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others, the ongoing COVID-19 pandemic and associated impact on our business, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Angela Salerno-Robin

    dna Communications

    ASalerno-Robin@dna-comms.com

    (212) 445-8219



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  26. SAN DIEGO, April 26, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that two abstracts related to Progenity's ingestible drug delivery technologies for the treatment of gastrointestinal disorders have been accepted for presentation at Digestive Disease Week® (DDW). The DDW Virtual Meeting, taking place May 21-23, 2021, is the world's premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.

    Details of the presentations are as follows:

    Session Title: Animal Models: Pre-Clinical Treatment of Intestinal…

    SAN DIEGO, April 26, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that two abstracts related to Progenity's ingestible drug delivery technologies for the treatment of gastrointestinal disorders have been accepted for presentation at Digestive Disease Week® (DDW). The DDW Virtual Meeting, taking place May 21-23, 2021, is the world's premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery.

    Details of the presentations are as follows:

    Session Title: Animal Models: Pre-Clinical Treatment of Intestinal Inflammation

    Session Date & Time: May 21, 2021 from 12:15 PM to 1:00 PM Eastern

    Presentation Title: Targeted Delivery of Soluble Tofacitinib Citrate to the Site of Inflammation to Improve Efficacy and Safety

    Session Title: Imaging Techniques and Technologies in GI

    Session Date & Time: May 23, 2021 from 12:15 PM to 1:00 PM Eastern

    Presentation Title: Development of a Novel Drug Delivery System 2 (DDS2) for Colon Targeted Delivery Treatment of Ulcerative Colitis (UC)

    The study findings will be a part of on-demand sessions which are embargoed until 12:15 p.m. Eastern the day the ePoster is presented. More information about these abstracts will be made available on the Progenity website following the conference.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619)743-6294



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  27. SAN DIEGO, April 08, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products in women's health, will be presenting verification study data for its Preecludia™ rule-out test for preeclampsia at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting set to take place April 30 – May 2, 2021.

    The data presented will be a part of the virtual meeting's interactive ePosters. Details of the presentation are as follows:

    Title Performance of a novel multi-biomarker rule out preeclampsia test: a prospective verification study
    Authors – Matthew Cooper, PhD, DABT, MBA; Amin Mazloom…

    SAN DIEGO, April 08, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products in women's health, will be presenting verification study data for its Preecludia™ rule-out test for preeclampsia at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting set to take place April 30 – May 2, 2021.

    The data presented will be a part of the virtual meeting's interactive ePosters. Details of the presentation are as follows:

    Title Performance of a novel multi-biomarker rule out preeclampsia test: a prospective verification study

    Authors – Matthew Cooper, PhD, DABT, MBA; Amin Mazloom, PhD; Chelsea Obrochta, PhD(c); Ronald Wapner, MD; Todd Rosen, MD; Allan Bombard, MD

    Poster number 999251

    ACOG anticipates publishing abstracts and posters the week of April 26th. The poster presentation will also be made available on the Progenity website following the conference.

    ABOUT PROGENITY, INC.

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Progenity Media Contact:

    Angela Salerno-Robin

    dna Communications

    ASalerno-Robin@dna-comms.com  

    (212) 445-8219 



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  28. SAN DIEGO, April 06, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products, today announced an agreement with Ionis Pharmaceuticals, the leader in RNA-targeted therapeutics, to evaluate the safety, tolerability and performance of Progenity's Oral Biotherapeutics Delivery System (OBDS) for oral systemic delivery of antisense oligonucleotides, developed and manufactured by Ionis.

    Ionis' novel antisense therapies are designed to target mRNA in a highly specific manner, so that the amount of disease-causing protein is dramatically decreased. Antisense therapies can also treat diseases caused by too little protein by…

    SAN DIEGO, April 06, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products, today announced an agreement with Ionis Pharmaceuticals, the leader in RNA-targeted therapeutics, to evaluate the safety, tolerability and performance of Progenity's Oral Biotherapeutics Delivery System (OBDS) for oral systemic delivery of antisense oligonucleotides, developed and manufactured by Ionis.

    Ionis' novel antisense therapies are designed to target mRNA in a highly specific manner, so that the amount of disease-causing protein is dramatically decreased. Antisense therapies can also treat diseases caused by too little protein by increasing the production of the protein, thereby restoring the protein to normal levels.

    The OBDS is an ingestible capsule based on a needle-free technology designed by Progenity to enable delivery of a drug formulated in a solution directly into the tissues of the small intestine, where it can be absorbed systemically.

    "We're excited to work with Ionis, a leader in nucleic-acid-based biotherapeutics, to collectively evaluate the ODBS platform for the oral delivery of antisense therapies," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "We believe the OBDS platform shows promise to transform the systemic delivery of diverse biotherapeutics via oral administration. Our primary focus has been the oral delivery of monoclonals, proteins, and peptides, and now we are potentially able to expand into nucleic-acid-based therapeutics."

    During the first phase of the study, Progenity and Ionis will evaluate the OBDS in conjunction with Ionis' drug for in vitro compatibility and performance as well as in vivo safety, tolerability and performance in a preclinical canine model.

    Progenity is developing an internal pipeline including PGN-OB1, an oral version of adalimumab and PGN-OB2, an oral version of a GLP-1 analog. The company expects that this collaboration could further demonstrate the versatility of the OBDS in delivering a range of different molecules.

    ABOUT PROGENITY, INC.

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    FORWARD LOOKING STATEMENTS

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development progress of our Oral Biotherapeutics Delivery System (OBDS), its future use with antisense therapies, and the performance of OBDS in an upcoming preclinical study. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the loss or retirement of key scientific or management personnel, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 18, 2021, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Progenity Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  29. Reports approximately 82,000 tests in the fourth quarter of 2020

    Raised $118M gross proceeds in December 2020 from a concurrent secondary equity offering and issuance of convertible notes, and $25M in gross proceeds from a recent private placement with two leading healthcare-focused investment funds

    Maintains 2021 revenue guidance range

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, March 18, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided corporate updates and reported financial results for the fourth quarter and full-year ended December…

    Reports approximately 82,000 tests in the fourth quarter of 2020

    Raised $118M gross proceeds in December 2020 from a concurrent secondary equity offering and issuance of convertible notes, and $25M in gross proceeds from a recent private placement with two leading healthcare-focused investment funds

    Maintains 2021 revenue guidance range

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, March 18, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided corporate updates and reported financial results for the fourth quarter and full-year ended December 31, 2020.

    Progenity made significant progress during the fourth quarter, both with its revenue generating business and notably with its innovation pipeline programs. The company continued to transition its core molecular testing business towards growth, increased its in-network position by adding national and regional contracts, and saw additional commercial and government payors covering average risk NIPT.

    Regarding its innovation pipeline programs, the company announced it successfully achieved the analytical and clinical verification milestone during the fourth quarter for its Preecludia™ preeclampsia rule-out test and has since initiated validation phase sample testing.

    "We continue to make progress in establishing a strong foundation and stabilizing our core molecular testing business. We anticipate these efforts will translate into improved operating performance and near-term growth, consistent with our 2021 guidance. We also recently secured funding from leading healthcare-focused investment funds, allowing us to expand our investor base. We are particularly excited with the progress and potential of our R&D pipeline which includes completing our Preecludia™ test's verification milestone and initiating the validation phase, advancing the Innatal 4 platform, and accelerating progress of our GI Precision Medicine programs," said Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity.

    Fourth Quarter 2020 Results and Other Corporate Highlights

    • Reported approximately 82,000 tests in the fourth quarter, including 56,000 core molecular tests and 26,000 COVID-19 tests.



    • Issued $168.5 million principal amount of 7.25% convertible senior notes due 2025 for gross proceeds of approximately $90.0 million and an additional $78.5 million principal amount of notes issued in exchange for the discharge of amounts outstanding under an existing credit and security agreement with entities affiliated with Athyrium Capital Management, LP.



    • Completed a concurrent underwritten secondary offering of common stock and issued approximately 8.8 million shares for gross proceeds of approximately $28.8 million.



    • In February 2021, raised approximately $25.0 million in gross proceeds from a private placement of approximately of 4.4 million shares of common stock and warrants to purchase an additional 4.4 million shares of common stock with two leading healthcare-focused investment funds.



    • Completed reduction in force, which resulted in the termination of approximately 9.5% of the Company's employees, to enable the Company to control its costs and more effectively align resources to business priorities. 



    • Increased in-network covered lives by up to 60 million with the addition of the MultiPlan national contract and added 1 million lives from additional regional payors.



    • Initiated validation phase for its Preecludia™ preeclampsia test, after successfully completing analytical and clinical verification.



    • Announced encouraging preclinical data supporting the potential of the Company's oral drug delivery system (DDS) using a proprietary autonomous localization technology designed to identify a key region of the GI tract for drug delivery.



    • Presented data from an award-winning abstract on a novel ingestible lab-in-a-capsule, PIL Dx, at the American College of Gastroenterology (ACG) 2020 Virtual Annual Meeting. The data in the presentation demonstrated the achievement of critical de-risking steps and Progenity's progress toward novel approaches for the assessment, diagnosis, and future treatment of gastrointestinal diseases through ingestible capsule devices.

    Fourth Quarter and Full-Year 2020 Financial Results

    Comparison of Three Months Ended December 31, 2020 and September 30, 2020

    Revenue was $14.3 million in the three months ended December 31, 2020, compared to $25.9 million in the three months ended September 30, 2020. The fourth quarter revenue includes a $10.7 million accrual as a reserve for potential payor settlements, as previously announced.

    Total accessioned tests volume, which includes the company's core molecular testing and COVID-19 testing, was 81,640 in the fourth quarter of 2020, a decrease of 3% compared to accessioned tests volume in the third quarter of 2020, which was 84,067 tests.

    Gross margin was negative 50.1% for the three months ended December 31, 2020, as a result of accruals against revenue, compared to 9.0% for the three months ended September 30, 2020.

    Operating expenses were $44.2 million for the three months ended December 31, 2020, compared to $46.9 million for the three months ended September 30, 2020.

    Net loss attributable to common stockholders was $75.5 million for the three months ended December 31, 2020 and basic and diluted net loss per share was $1.53, compared to a net loss attributable to common stockholders of $47.1 million and a net loss per share of $1.01 for the three months ended September 30, 2020.

    Comparison of Three Months Ended December 31, 2020 and 2019

    Revenue was $14.3 million in the three months ended December 31, 2020, compared to $20.5 million in the three months ended December 31, 2019. The decrease in revenue was primarily attributable to a decrease in test volumes in 2020 as a result of the COVID-19 pandemic, partially offset by a decrease, as compared to the prior period, of $9.2 million in payor settlement reserves and accruals.

    Gross margin was negative 50.1% for the three months ended December 31, 2020, as a result of accruals against revenue, compared to negative 21.9% for the three months ended December 31, 2019.

    Operating expenses were $44.2 million for the three months ended December 31, 2020, compared to $44.5 million in the three months ended December 31, 2019.

    Net loss attributable to common stockholders was $75.5 million for the three months ended December 31, 2020 and basic and diluted net loss per share was $1.53, compared to a net loss attributable to common stockholders of $86.8 million and a net loss per share of $17.46 for the three months ended December 31, 2019.

    Comparison of Full-Year Ended December 31, 2020 and 2019

    Revenue was $74.3 million in the year ended December 31, 2020, compared to $144.0 million in the year ended December 31, 2019. The decrease in revenues was largely attributable to a decrease in test volumes as a result of the COVID-19 pandemic during the second, third and fourth quarters of 2020, partially offset by a decrease, as compared to the prior period, of $6.2 million in payor settlement reserves and accruals.

    Gross margin was negative 25.7% for the year ended December 31, 2020, compared to 30.2% for the year ended December 31, 2019.

    Operating expenses were $176.1 million for the year ended December 31, 2020, compared to $183.6 million in the year ended December 31, 2019.

    Net loss attributable to common stockholders was $192.8 million for the year ended December 31, 2020 and basic and diluted net loss per share was $7.01, compared to a net loss attributable to common stockholders of $228.8 million and a net loss per share of $46.87 for the year ended December 31, 2019.

    Cash and cash equivalents were $92.1 million as of December 31, 2020. As of December 31, 2020, Progenity had 55.8 million shares outstanding, excluding shares issued in our recent private placement.

    COVID-19 Update

    Public health measures related to the novel coronavirus are greatly impacting healthcare practices. We have responded to the COVID-19 pandemic by implementing and maintaining robust response plans, seamlessly continuing laboratory operations and maintaining pre-pandemic turnaround times. We enhanced our digital sales and support capabilities, increased proactive test reporting and remote genetic counseling capabilities, and expanded our mobile phlebotomy services, assisting our customers to continue serving their patients with the same quality care.

    Webcast and Conference Call Information

    Progenity will host a webcast and conference call to discuss the second quarter financial results and answer investment community questions today, Thursday, March 18, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 9677695. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the impact of the COVID-19 pandemic on our business, operations, financial results, and future performance, and the progress of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, the ongoing COVID-19 pandemic, our ability to develop and commercialize our testing products as well as innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding future test volumes and revenues, our expectations regarding our in network position, anticipated capacity for our tests, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Annual Report on Form 10-K for the year ended December 31, 2020 to be filed with the SEC and other subsequent documents we file with the SEC.

    Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436



    Progenity, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

      Three Months Ended 
      December 31,

    2020
      September 30,

    2020
     
    Revenues (1) $14,276  $25,943 
    Cost of sales  21,427   23,601 
    Gross profit (loss)  (7,151)  2,342 
    Operating expenses:        
    Research and development  11,226   13,043 
    Selling and marketing  12,471   13,244 
    General and administrative  20,523   20,626 
    Total operating expenses  44,220   46,913 
    Loss from operations  (51,371)  (44,571)
    Interest expense  (2,699)  (2,476)
    Interest and other income (expense), net  (21,294)  (18)
    Loss before income taxes  (75,364)  (47,065)
    Income tax expense  164    
    Net loss  (75,528)  (47,065)
    Dividend paid to preferred stockholders      
    Net loss attributable to common stockholders $(75,528) $(47,065)
    Net loss per share attributable to common stockholders, basic and diluted $(1.53) $(1.01)
    Weighted average number of shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted  49,288,579   46,632,043 

    __________________

    (1)Revenues for the three months ended December 31, 2020 reflect an accrual of $10.7 million recorded as a reserve for potential payor settlements.



    Progenity, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

      Three Months Ended

    December 31,
      Year Ended

    December 31,
     
      2020  2019  2020  2019 
              (1)  (1) 
    Revenues (2) $14,276  $20,476  $74,313  $143,985 
    Cost of Sales  21,427   24,961   93,433   100,492 
    Gross profit (loss)  (7,151)  (4,485)  (19,120)  43,493 
    Operating Expenses:                
    Research and development  11,226   14,609   47,743   63,400 
    Selling and marketing  12,471   13,378   52,887   58,888 
    General and administrative  20,523   16,501   75,438   61,324 
    Total operating expenses  44,220   44,488   176,068   183,612 
    Loss from operations  (51,371)  (48,973)  (195,188)  (140,119)
    Interest expense  (2,699)  (2,327)  (9,984)  (9,199)
    Interest and other income (expense), net  (21,294)  118   (24,888)  575 
    Loss before income taxes  (75,364)  (51,182)  (230,060)  (148,743)
    Income tax expense (benefit)  164   (706)  (37,532)  (706)
    Net loss  (75,528)  (50,476)  (192,528)  (148,037)
    Dividend paid to preferred shareholders        (268)  (3,652)
    Stock dividend on exchange of Series A-1 to Series B Preferred Stock           (27,637)
    Stock dividend on Series B Preferred Stock     (36,364)     (49,501)
    Net loss attributable to common shareholders $(75,528) $(86,840) $(192,796) $(228,827)
    Net loss per share attributable to common shareholders, basic and diluted $(1.53) $(17.46) $(7.01) $(46.87)
    Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted  49,288,579  4,974,825   27,512,876   4,882,662 

    __________________

    (1)The condensed consolidated statement of operations data for the year ended December 31, 2020 and 2019 has been derived from the audited consolidated financial statements.
      
    (2)Revenues for the three months ended December 31, 2020 reflect a revenue reserve accrual of $10.7 million recorded for payor settlements. Revenues for the three months ended December 31, 2019 reflect an accrual of $19.9 million related to the settlements with the Department of Justice (DOJ) and the participating State Attorneys General (AGs).
      
     Revenues for the year ended December 31, 2020 reflect an aggregate revenue reserve accrual of $33.5 million related to the settlement with the DOJ and the participating State AGs and other payors settlements. Revenues for the year ended December 31, 2019 reflect a $39.7 million aggregate revenue reserve accrual related to the settlements with the DOJ and the participating State AGs and reimbursement claims and settlements with other payors.



    Progenity, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)

      December 31,

    2020
      December 31,

    2019
     
      (1)  (1) 
    Assets        
    Current assets:        
    Cash and cash equivalents $92,076  $33,042 
    Accounts receivable, net  12,682   22,189 
    Inventory  12,219   10,937 
    Income tax receivable     634 
    Prepaid expenses and other current assets  9,361   7,846 
    Total current assets  126,338   74,648 
    Property and equipment, net  17,842   15,891 
    Goodwill and other intangible assets  10,062   10,990 
    Other assets  198   198 
    Total assets $154,440  $101,727 
    Liabilities and Stockholders' Deficit        
    Current liabilities:        
    Accounts payable $17,410  $15,754 
    Accrued expenses and other current liabilities  54,677   83,615 
    Current portion of mortgages payable and capital lease obligations  583   968 
    Total current liabilities  72,670   100,337 
    Mortgages payable and capital lease obligations, net of current portion  2,841   3,439 
    Convertible notes, net  158,886    
    Note payable to related party, net     68,966 
    Embedded derivative liability  18,370    
    Other long-term liabilities  8,667   12,859 
    Total liabilities $261,434  $185,601 
    Stockholders' deficit:        
    Common stock  59   9 
    Series A Preferred Stock     4 
    Series B Preferred Stock     102 
    Additional paid-in capital  452,992   283,260 
    Accumulated deficit  (541,274)  (348,478)
    Treasury stock  (18,771)  (18,771)
    Total stockholders' deficit  (106,994)  (83,874)
    Total liabilities and stockholders' deficit $154,440  $101,727 

    ____________

    (1)The condensed consolidated balance sheet data at December 31, 2020 and 2019 has been derived from the audited consolidated financial statements.


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  30. SAN DIEGO, March 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report fourth quarter and full year 2020 financial results on Thursday, March 18, 2021 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 9677695. A live webcast and archive of the call will be available online…

    SAN DIEGO, March 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report fourth quarter and full year 2020 financial results on Thursday, March 18, 2021 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 9677695. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  31. SAN DIEGO, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it has entered into a definitive securities purchase agreement with two leading healthcare-focused investment funds for the sale of units consisting of shares of common stock and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to Progenity of approximately $25 million, before deducting placement agent commissions and other offering expenses.

    Pursuant to the terms of the securities purchase agreement, at the closing of the private placement…

    SAN DIEGO, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it has entered into a definitive securities purchase agreement with two leading healthcare-focused investment funds for the sale of units consisting of shares of common stock and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to Progenity of approximately $25 million, before deducting placement agent commissions and other offering expenses.

    Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Progenity will issue units representing an aggregate of 4,370,629 million shares of common stock and warrants to purchase an aggregate of 4,370,629 million shares of common stock. The aggregate purchase price of each unit, which consists of one share of common stock plus a warrant to purchase one share of common stock, is $5.72. The warrants will have a per share exercise price of $6.86 and will be exercisable for cash at any time on or after the closing date and through the fifth anniversary of the closing date. The price per unit was based in part upon the average of the last five closing prices of the common stock on the Nasdaq Global Market. If exercised for cash, the warrants would result in additional gross proceeds to Progenity of approximately $30 million.

    The private placement is expected to close on February 25, 2021, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Progenity with the Securities and Exchange Commission ("SEC").

    Progenity intends to use the net proceeds to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform, and for working capital and general corporate purposes.

    Piper Sandler & Co. served as lead placement agent on the offering with Raymond James & Associates, Inc. acting as co-placement agent.

    The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Progenity has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's expectations regarding the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the expected receipt of proceeds from the private placement, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties related to market conditions and the completion of the offerings on the anticipated terms or at all, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents filed with the SEC. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619-743-6294) 



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  32. SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products, today announced the initiation of a clinical study for their Drug Delivery System (DDS) capsule, an ingestible and self-guided drug delivery device. The study will evaluate the capsule's safety and tolerability in the gastrointestinal (GI) tract of Normal Healthy Volunteers (NHV). The study will also collect the first clinical data on the ability of the DDS to auto-locate and accurately deliver a payload to the colon, a key delivery site for the treatment of ulcerative colitis.

    This study will investigate the in vivo behavior of the DDS using…

    SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success developing and commercializing molecular testing products, today announced the initiation of a clinical study for their Drug Delivery System (DDS) capsule, an ingestible and self-guided drug delivery device. The study will evaluate the capsule's safety and tolerability in the gastrointestinal (GI) tract of Normal Healthy Volunteers (NHV). The study will also collect the first clinical data on the ability of the DDS to auto-locate and accurately deliver a payload to the colon, a key delivery site for the treatment of ulcerative colitis.

    This study will investigate the in vivo behavior of the DDS using the well-established method of scintigraphic characterization. Gamma scintigraphy will be used to validate the DDS GI localization as well as the drug delivery accuracy using a saline solution payload that includes radioisotopes. The DDS capsule will be evaluated in a single-dose application to approximately 12 subjects in three separate dosing cohorts. Results of the study are expected in the second quarter of this year.

    "This research is a significant step in our efforts toward improving the management of ulcerative colitis, where therapy is often challenged by the inability to achieve sufficient drug concentrations at the site of disease without incurring dose-limiting side effects," said William Sandborn MD, Chief of the Division of Gastroenterology and Director of the Inflammatory Bowel Disease Center at the University of California San Diego. "Verifying the safety and tolerability of this drug delivery system will allow us to advance this technology to potentially provide a noninvasive, oral solution for safe and effective treatment of this and other GI diseases."

    Progenity designed the DDS capsule with the aim of ultimately using it to deliver bolus doses of therapeutic compounds formulated in proprietary solutions at a defined location within the GI tract. If successful, the DDS could be used to transport previously approved therapeutics directly to their intended disease target in the GI tract, thereby improving efficacy through increased localized drug concentration while potentially minimizing harmful side effects associated with systemic drug delivery. This technology offers the potential to improve treatment for patients suffering from conditions such as ulcerative colitis (UC) and inflammatory bowel disease (IBD). Current drug treatments for these conditions suffer from less than optimal efficacies at safe doses, leading to a loss of response in the majority of patients within the first few years of treatment.

    Progenity has two lead drug-device candidates utilizing the DDS technology: PGN-001, a high-concentration, liquid formulation of adalimumab, and PGN-600 a liquid formulation of tofacitinib. Both are under development for the treatment of ulcerative colitis. Using intracecal catheter preclinical colitis models, the company previously observed significant efficacy, as well as both high local tissue drug levels with localized drug delivery and reduced systemic drug exposure, compared to systemic injection.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements regarding the development progress of our Drug Delivery System (DDS) capsule, its future use in managing ulcerative colitis, and the performance of the Drug Delivery System (DDS) capsule in an upcoming clinical study. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the loss or retirement of key scientific or management personnel, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com 

    (619) 743-6294

     



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  33. SAN DIEGO, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, applauds the continuing focus of the Society for Maternal-Fetal Medicine (SMFM) on the challenges of diagnosing and managing preeclampsia. Preeclampsia was the focus of this year's President's Workshop at the SMFM 2021 Virtual Annual Meeting, co-hosted by the Preeclampsia Foundation.

    The SMFM President's Workshop highlighted the latest research in diagnosing and managing patients with preeclampsia. The session titled Gray Zone Preeclampsia confirmed and highlighted the challenges of diagnosing preeclampsia due to non-specific symptoms…

    SAN DIEGO, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, applauds the continuing focus of the Society for Maternal-Fetal Medicine (SMFM) on the challenges of diagnosing and managing preeclampsia. Preeclampsia was the focus of this year's President's Workshop at the SMFM 2021 Virtual Annual Meeting, co-hosted by the Preeclampsia Foundation.

    The SMFM President's Workshop highlighted the latest research in diagnosing and managing patients with preeclampsia. The session titled Gray Zone Preeclampsia confirmed and highlighted the challenges of diagnosing preeclampsia due to non-specific symptoms, overlap with other hypertensive disorders of pregnancy, and limited diagnostic tools. Other sessions focused on the promise of biomarkers and multi-omics as part of the ongoing research on preeclampsia.

    The SMFM publication, American Journal of Obstetrics & Gynecology (AJOG) also recently published an article by Redman, et.al., highlighting the complexity of preeclampsia, which is a syndrome involving multiple pathophysiological pathways. The authors stress there is an urgent need to understand the complex, multi-factorial pathways of preeclampsia at the cellular level, including biomarkers, to better characterize and manage patients.

    The Preeclampsia Foundation, co-hosts of the SMFM President's Workshop, issued a national call to action in October for the development of biomarker tests specific to the pathophysiology of preeclampsia due to this unmet need.

    "We have heard very clearly from the SMFM, the Preeclampsia Foundation, and healthcare providers across the country, that new technology to evaluate risk for preeclampsia is urgently needed. We believe that biomarker testing is important, because complex syndromes require sophisticated solutions," said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity. "We are responding to these needs by preparing for launch of the Preecludia™ test, our novel preeclampsia biomarker assay. We look forward to announcing additional milestones throughout 2021 as we usher in a new era of risk assessment for preeclampsia."

    The Preecludia rule-out test for preeclampsia could be the first of its kind in the United States to help healthcare providers evaluate patients with signs and symptoms of possible preeclampsia. This novel, multi-analyte, protein biomarker assay is designed to look at markers across multiple pathophysiological pathways to assess risk for preeclampsia. The laboratory developed test requires a simple blood draw, and is designed to aid in the triage and management of preeclampsia. Last November, the company released strong clinical and analytical verification data, and it plans to enter the validation phase later in Q1, followed by a targeted launch in the second half of 2021.

    Preeclampsia is the second most common cause of maternal mortality, and more than 700,000 women present each year with signs and symptoms of possible preeclampsia. Preeclampsia is characterized as a hypertensive disorder, but it is difficult to differentiate from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Preeclampsia can result in impaired organ function, seizures, stroke, and death, and often requires pre-term delivery of the baby. This can result not only in poor health outcomes, but also significant healthcare costs.

    For further information about preeclampsia and the Preecludia test, access the slides presented at the company's Preeclampsia R&D Day at: progenity.com/presentations.

    For more information about Progenity's products and pipeline visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements the development progress of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the performance of the rule-out test in an upcoming validation study, the completion of our upcoming validation study, and our efforts and intent to commercialize the Preecludia test and address an unmet medical need. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the size and growth potential of the markets for our products, and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the outcome of pending and future investigations and legal proceedings, the loss or retirement of key scientific or management personnel, our ability to develop and maintain our corporate infrastructure, including maintaining effective internal controls, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  34. SAN DIEGO, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, is scheduled to participate in two upcoming virtual investor conferences:

    • A fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference at 2 p.m. ET / 11 a.m. PT on February 17, 2021; and

    • A fireside chat at the Raymond James 42nd Annual Institutional Investors Conference at 3 p.m. ET / 12 p.m. PT on March 3, 2021.

    A live audio webcast of the fireside chats will be available in the Investors section of…

    SAN DIEGO, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, is scheduled to participate in two upcoming virtual investor conferences:

    • A fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference at 2 p.m. ET / 11 a.m. PT on February 17, 2021; and



    • A fireside chat at the Raymond James 42nd Annual Institutional Investors Conference at 3 p.m. ET / 12 p.m. PT on March 3, 2021.

    A live audio webcast of the fireside chats will be available in the Investors section of the company's website at progenity.com/presentations, with an archived replay available following each event.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  35. SALT LAKE CITY, Feb. 8, 2021 /PRNewswire/ -- PROG Holdings, Inc. (NYSE-PRG), a leading provider of lease-purchase solutions, will host a conference call and webcast on Thursday, February 25, 2021, at 8:30 a.m. Eastern Time to discuss its fourth quarter 2020 financial results scheduled for release before the market opens on that day.

    The public is invited to listen to the call by dialing 877-270-2148 a few minutes before the scheduled start time and requesting to join the PROG Holdings, Inc. call. For international participants the number is 412-902-6510. The call will also be accessible by visiting the company's investor relations website at investor.progleasing.com. The webcast will be archived for playback at that same site.

    About PROG Holdings, Inc.

    Headquartered in SALT LAKE CITY, PROG Holdings, Inc. (NYSE-PRG) is the holding company of Progressive Leasing, a leading provider of lease-purchase solutions for consumers at the point of sale at many national, regional and local retailers and e-commerce websites. Progressive Leasing offers a lease-to-own payment solution for consumers to acquire furniture, appliances, jewelry, electronics, bedding, cell phones, wheel and tire and other large ticket consumer durables through over 20,000 locations in 46 states as well as with e-commerce POS sites. Vive Financial provides a variety of second-look credit products that are originated through federally insured banks. For more information, visit ProgLeasing.com and Vivecard.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/prog-holdings-inc-announces-fourth-quarter-2020-earnings-call-and-webcast-301223564.html

    SOURCE PROG Holdings, Inc.

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  36. SAN DIEGO, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, has reported the completion of two million diagnostic tests by its CLIA-certified and CAP-accredited laboratory in Ann Arbor, Michigan. This notable milestone comes as Progenity celebrates the ten-year anniversary of the company's founding.

    Progenity was established in 2011 as a women's health molecular diagnostics company offering a genetic carrier test for the detection of cystic fibrosis. Today, the company has commercialized a portfolio of diagnostic products, including the Preparent® Carrier Test for hereditary genetic diseases; the…

    SAN DIEGO, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, has reported the completion of two million diagnostic tests by its CLIA-certified and CAP-accredited laboratory in Ann Arbor, Michigan. This notable milestone comes as Progenity celebrates the ten-year anniversary of the company's founding.

    Progenity was established in 2011 as a women's health molecular diagnostics company offering a genetic carrier test for the detection of cystic fibrosis. Today, the company has commercialized a portfolio of diagnostic products, including the Preparent® Carrier Test for hereditary genetic diseases; the Innatal® Prenatal Screen for chromosomal disorders; the Riscover® Hereditary Cancer test, and the Resura® Prenatal Test, which provides noninvasive prenatal screening for monogenic diseases.

    "Achieving the milestone of two million tests performed in the Progenity laboratory demonstrates our strong commercial capabilities in bringing to market and sustaining leading-edge diagnostic products," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity. "This is an incredibly exciting time for Progenity. We look forward to additional milestones to come during 2021 as we leverage our capabilities toward the development of our innovative product pipeline, including the first-of-its-kind Preecludia™ test for preeclampsia, our single-molecule detection platform for NIPT, and our novel ingestible technologies for diagnosis and treatment of gastrointestinal disorders."

    Progenity's preeclampsia rule-out test, Preecludia™, has the potential to be the first test in the United States to help healthcare providers evaluate patients who have symptoms of possible preeclampsia, a potentially deadly condition for both pregnant mothers and their babies. This novel protein biomarker assay is designed to address the unmet need for tools to aid in the triage and management of preeclampsia. The Preeclampsia Foundation recently issued a national call to action for the development of biomarker tests specific to the pathophysiology of preeclampsia due to this unmet need. Last November, the company released strong verification performance data for Preecludia and plan to enter validation later in Q1, followed by a targeted launch in the second half of 2021.

    Progenity is also building upon its core competencies in molecular testing by developing and commercializing a disruptive platform of gastrointestinal (GI) health diagnostics and targeted therapeutics. Leveraging a proprietary autonomous localization technology, Progenity is developing a noninvasive, ingestible capsule technology platform, with investigational devices and drug/device combinations designed for both diagnostic and therapeutic purposes. Progenity believes product candidates, if successfully developed and approved or cleared, could become the first precision medicine products to diagnose and treat at the site of disease within the GI tract.

    For more information about Progenity's products and pipeline, visit www.progenity.com, or follow the company on LinkedIn or Twitter.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements the development progress of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the performance of the rule-out test in an upcoming validation study, the completion of our upcoming validation study, our efforts and intent to commercialize the Preecludia test and address an unmet medical need and the development progress of our novel ingestible technologies for diagnosis and treatment of gastrointestinal disorders. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the loss or retirement of key scientific or management personnel, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  37. Total 2021 revenue expected to grow by up to 30%1, reaching a range of $130 to $145 million

    Core molecular testing2 volume expected to grow by up to 16%

    SAN DIEGO, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided 2021 full-year financial guidance.

    "The year 2020 proved to be a transitional period for Progenity, especially in light of the adverse impact to revenue and volume due to transient revenue cycle changes in the second half of the year. We expect that we will return to strong, sustained revenue and volume growth in 2021 led by expansion of our core product lines and additional…

    Total 2021 revenue expected to grow by up to 30%1, reaching a range of $130 to $145 million

    Core molecular testing2 volume expected to grow by up to 16%

    SAN DIEGO, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided 2021 full-year financial guidance.

    "The year 2020 proved to be a transitional period for Progenity, especially in light of the adverse impact to revenue and volume due to transient revenue cycle changes in the second half of the year. We expect that we will return to strong, sustained revenue and volume growth in 2021 led by expansion of our core product lines and additional testing capacity for SARS CoV-2 test services. We also remain on track to complete the clinical validation of our preeclampsia rule out test, Preecludia™, by mid-year and to prepare for launch in the second half of the year. We've also made significant progress with our potentially transformative Innatal 4 technology and continued advances and partnerships negotiations relating to our GI portfolio," said Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity. "In addition, we are committed to actively managing our SG&A costs and will maintain disciplined R&D spend throughout the year."

    Financial Guidance for 2021

    Core molecular testing revenue:$115 to $125 million3
    SARS CoV-2 revenue:$15 to $20 million
    Total revenue:$130 to $145 million

    (estimated annual growth of up to 30%1)
      
    SG&A expense:$150 to $160 million
    R&D expense:$50 to $55 million
      
    Core molecular testing volume2:290,000 to 310,000
    SARS CoV-2 volume:275,000 to 300,000

    1 Growth of annual 2021 revenue guidance over estimated 2020 revenues ex-accruals (a reconciliation of 2020 revenue ex-accruals to its comparable GAAP figure (revenue) is not available due to the unpredictability of accruals, if any. In addition, the magnitude of any such accruals may be significant, as discussed in our periodic reports previously filed with the SEC.)

    2 Volume for Innatal, Preparent, Riscover tests

    3 Includes revenues from Avero affiliate

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit www.progenity.com.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the impact of the COVID-19 pandemic on our business, operations, financial results, and future performance, and the progress of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release, including revenue, expense and volume guidance for the fiscal year 2021. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, the ongoing COVID-19 pandemic, our ability to develop and commercialize our testing products as well as innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, disputes with third party payors with respect to reimbursement and recoupment, our expectations regarding future revenue, costs and test volumes, our expectations regarding our in network position, anticipated capacity for our tests, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC and other subsequent documents we file with the SEC.

    We expressly disclaim any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436 



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  38. SAN DIEGO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced its participation in the 2021 ICR Conference. Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, will present a company overview on Thursday, January 14, 2021 at 4 p.m. ET (1 p.m. PT).

    A live audio webcast of the presentation will be available in the Investors section of the company's website at progenity.com/presentations, with an archived replay available following the event.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing…

    SAN DIEGO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced its participation in the 2021 ICR Conference. Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, will present a company overview on Thursday, January 14, 2021 at 4 p.m. ET (1 p.m. PT).

    A live audio webcast of the presentation will be available in the Investors section of the company's website at progenity.com/presentations, with an archived replay available following the event.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  39. SAN DIEGO, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products in women's health, today announced that it is expanding the availability of COVID-19 RT-PCR testing across the United States to support the rising demand for testing.

    "Meeting the current need for COVID-19 testing requires support from every organization in a position to contribute to the national effort," said Harry Stylli, PhD, CEO, chairman and co-founder of Progenity. "We are able to leverage our molecular testing experience initially to support our women's health providers who need testing for patients and staff members, as well as…

    SAN DIEGO, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products in women's health, today announced that it is expanding the availability of COVID-19 RT-PCR testing across the United States to support the rising demand for testing.

    "Meeting the current need for COVID-19 testing requires support from every organization in a position to contribute to the national effort," said Harry Stylli, PhD, CEO, chairman and co-founder of Progenity. "We are able to leverage our molecular testing experience initially to support our women's health providers who need testing for patients and staff members, as well as offering our expanded COVID-19 testing services nationally."

    Progenity is now offering "gold-standard" RT-PCR testing for COVID-19 through the CLIA-certified and CAP-accredited laboratory of its affiliate, Avero Diagnostics, in all states except New York. Testing is performed using the Thermo Fisher Applied Biosystems TaqPath COVID-19 Combo Kit, under Emergency Use Authorization by the FDA. All testing is provider directed. The current turnaround time for testing is 24-48 hours, with 97% of tests performed to date reported within 24 hours of receipt. For more information, please visit www.progenity.com/COVID19.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    IR@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  40. SAN DIEGO, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the closing of its offering of $85,525,000 aggregate principal amount of 7.25% convertible senior notes due 2025 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The notes issued today include $10,525,000 principal amount of notes issued pursuant to the partial exercise by the initial purchaser of an option to purchase additional notes.

    Certain entities affiliated with Athyrium Capital Management, LP ("Athyrium…

    SAN DIEGO, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the closing of its offering of $85,525,000 aggregate principal amount of 7.25% convertible senior notes due 2025 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The notes issued today include $10,525,000 principal amount of notes issued pursuant to the partial exercise by the initial purchaser of an option to purchase additional notes.

    Certain entities affiliated with Athyrium Capital Management, LP ("Athyrium"), an affiliate of Progenity, have acquired $103.5 million in aggregate principal amount of notes, consisting of $25.0 million principal amount of notes to be purchased for cash in the offering and, pursuant to a separate exchange agreement, an additional $78.5 million principal amount of notes issued in exchange for the discharge of amounts outstanding under Progenity's credit and security agreement with an affiliate of Athyrium.

    In a separate press release, Progenity also announced today the closing of its previously announced underwritten public offering of 7,645,259 shares of common stock, at a public offering price of $3.27 per share. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any common stock in the public offering.

    The notes offering and the underwritten public offering of common stock together generated aggregate gross proceeds of $110.5 million. Progenity intends to use the net proceeds from the offering, together with the net proceeds from the underwritten public offering of common stock referred to above, to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform, and for working capital and general corporate purposes.

    The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward-Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's expectations regarding intended use of the net proceeds are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents filed with the SEC. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Contact Information

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436



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  41. SAN DIEGO, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the closing of its previously announced underwritten public offering of 7,645,259 shares of its common stock at a public offering price of $3.27 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Progenity, are approximately $25.0 million. All of the shares are being offered by Progenity. Piper Sandler & Co. and Wells Fargo Securities, LLC acted as joint book-running managers for the offering of common stock. BTIG, LLC…

    SAN DIEGO, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the closing of its previously announced underwritten public offering of 7,645,259 shares of its common stock at a public offering price of $3.27 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Progenity, are approximately $25.0 million. All of the shares are being offered by Progenity. Piper Sandler & Co. and Wells Fargo Securities, LLC acted as joint book-running managers for the offering of common stock. BTIG, LLC acted as the lead manager for the offering of common stock.

    The shares of common stock described above were offered by Progenity pursuant to a registration statement filed with the Securities and Exchange Commission (the "SEC") that became effective on December 2, 2020. The offering was made solely by means of a prospectus. A final prospectus was filed with the SEC and is available for free on the SEC's website at http://www.sec.gov, copies of which may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at (800) 326-5897 or email a request to cmclientsupport@wellsfargo.com.

    In a separate press release, Progenity also announced today the closing of its previously announced private offering and issuance of $85,525,000 aggregate principal amount of 7.25% convertible senior notes due 2025 (the "notes"). Progenity also granted the initial purchaser of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $15.0 million principal amount of notes, and the notes issued today include $10,525,000 principal amount of notes issued pursuant to the partial exercise of such option by the initial purchaser.

    The notes offering and the underwritten public offering of common stock together generated aggregate gross proceeds of $110.5 million. Progenity intends to use the net proceeds from the offering, together with the net proceeds from the private offering of the notes, to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform, and for working capital and general corporate purposes.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's intended use of the net proceeds are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents filed with the SEC. Progenity claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  42. SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG) today announced the pricing of its offering of $75.0 million aggregate principal amount of 7.25% convertible senior notes due 2025 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. Progenity also granted the initial purchaser of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $15.0 million principal amount of notes.

    The notes will be senior…

    SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG) today announced the pricing of its offering of $75.0 million aggregate principal amount of 7.25% convertible senior notes due 2025 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. Progenity also granted the initial purchaser of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $15.0 million principal amount of notes.

    The notes will be senior, unsecured obligations of Progenity and will accrue interest at a rate of 7.25% per annum, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on June 1, 2021. The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted. At any time from, and including, the date that is 30 calendar days after the initial closing date of this offering and before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into shares of Progenity's common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. In addition, noteholders that convert their notes before December 1, 2022 will, in certain circumstances, be entitled to an additional cash payment representing the present value of any remaining interest payments on the notes through December 1, 2022. The initial conversion rate is 278.0094 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $3.60 per share of common stock. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.

    The notes will be redeemable, in whole and not in part, for cash at Progenity's option at any time on or after December 1, 2023, but only if the last reported sale price per share of Progenity's common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.

    If a "fundamental change" (as defined in the indenture for the notes) occurs, then noteholders may require Progenity to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

    Progenity estimates that the net proceeds from the offering will be approximately $70.8 million (or approximately $85.0 million if the initial purchaser fully exercise its option to purchase additional notes), after deducting the initial purchaser's discounts and commissions and estimated offering expenses. Progenity intends to use the net proceeds from the offering, together with the net proceeds from the underwritten public offering of common stock referred to below, to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform, and for working capital and general corporate purposes.

    Certain entities affiliated with Athyrium Capital Management, LP ("Athyrium"), one of Progenity's affiliates, have agreed to acquire up to $103.5 million in aggregate principal amount of notes, consisting of $25.0 million principal amount of notes to be purchased for cash in the offering and, pursuant to a separate exchange agreement, an additional $78.5 million principal amount of notes to be issued in exchange for the discharge of amounts outstanding under Progenity's credit and security agreement with a fund managed by Athyrium.

    In a separate press release, Progenity also announced today the pricing of its previously announced underwritten public offering of 7,645,259 shares of common stock, at a public offering price of $3.27 per share. The issuance and sale of the common stock are scheduled to settle on December 7, 2020, subject to customary closing conditions. Progenity also granted the underwriters of the common stock offering a 30-day option to purchase up to an additional 1,146,788 shares of common stock. The completion of the offering of the notes is not contingent on the completion of the offering of common stock, and the completion of the offering of common stock is not contingent on the completion of offering of the notes. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any common stock in the public offering.

    The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward-Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's expectations regarding the consummation of the offerings, the satisfaction of customary closing conditions with respect to the offerings and the anticipated use of the net proceeds are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties related to market conditions and the completion of the offerings on the anticipated terms or at all, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents filed with the SEC. Progenity claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Contact Information

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436



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  43. SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the pricing of its previously announced underwritten public offering of 7,645,259 shares of its common stock at a public offering price of $3.27 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Progenity, are expected to be approximately $25.0 million. All of the shares are being offered by Progenity. Progenity has granted the underwriters a 30-day option to purchase up to an additional 1,146,788 shares of common stock…

    SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the pricing of its previously announced underwritten public offering of 7,645,259 shares of its common stock at a public offering price of $3.27 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Progenity, are expected to be approximately $25.0 million. All of the shares are being offered by Progenity. Progenity has granted the underwriters a 30-day option to purchase up to an additional 1,146,788 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on December 7, 2020, subject to the satisfaction of customary closing conditions. Progenity expects to use the net proceeds from the offering to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform and for working capital and general corporate purposes.

    In a separate press release, Progenity also announced today the pricing of its previously announced private offering of $75,000,000 aggregate principal amount of 7.25% convertible senior notes due 2025 (the "notes"), plus up to an additional $15,000,000 aggregate principal amount of notes that the initial purchaser of the notes has the option to purchase from Progenity. The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. The completion of the offering of common stock is not contingent on the completion of the offering of the notes, and the completion of the offering of notes is not contingent on the completion of offering of common stock. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any notes or any shares of common stock issuable upon conversion of the notes.

    Piper Sandler & Co. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering of common stock. BTIG, LLC is acting as the lead manager for the offering of common stock.

    A registration statement relating to the offering of common stock became effective on December 2, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at (800) 326-5897 or email a request to cmclientsupport@wellsfargo.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's expectations regarding the consummation of the offerings, the satisfaction of customary closing conditions with respect to the offerings and the anticipated use of the net proceeds are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties related to market conditions and the completion of the offerings on the anticipated terms or at all, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents filed with the SEC. Progenity claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  44. SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG) today announced its intention to offer, subject to market and other conditions, $75 million aggregate principal amount of convertible senior notes due 2025 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Progenity also expects to grant the initial purchaser of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $15 million principal amount of notes.

    The notes will be senior, unsecured obligations of Progenity, will accrue interest payable semi-annually in arrears…

    SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG) today announced its intention to offer, subject to market and other conditions, $75 million aggregate principal amount of convertible senior notes due 2025 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Progenity also expects to grant the initial purchaser of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $15 million principal amount of notes.

    The notes will be senior, unsecured obligations of Progenity, will accrue interest payable semi-annually in arrears and will mature on December 1, 2025, unless earlier repurchased, redeemed or converted. At any time from and including the date that is 30 calendar days after the initial closing date of the offering and before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into shares of Progenity's common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. In addition, noteholders that convert their notes before December 1, 2022 will, in certain circumstances, be entitled to an additional cash payment upon conversion. The notes will be redeemable, in whole and not in part, for cash at Progenity's option at any time on or after December 1, 2023, but only if the last reported sale price per share of Progenity's common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

    Progenity intends to use the net proceeds from the offering, together with the net proceeds from the underwritten public offering of common stock referred to below, to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform, and for working capital and general corporate purposes.

    Certain entities affiliated with Athyrium Capital Management, LP ("Athyrium"), one of Progenity's affiliates, have indicated their intent to acquire up to $103.5 million in aggregate principal amount of notes, consisting of up to $25 million principal amount of affiliate notes to be purchased for cash in the offering and, pursuant to a separate exchange agreement, up to an additional $78.5 million principal amount of affiliate notes to be issued in exchange for the discharge of amounts outstanding under Progenity's credit and security agreement with a fund managed by Athyrium.

    In a separate press release, Progenity also announced today its intention to offer, in a separate, underwritten public offering, subject to market and other conditions, $25 million of shares of its common stock, plus up to an additional $3.75 million of shares of its common stock that the underwriters of the common stock offering have the option to purchase from Progenity. The completion of the offering of the notes is not contingent on the completion of the offering of common stock, and the completion of the offering of common stock is not contingent on the completion of offering of the notes. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any common stock in the public offering.

    The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements regarding the anticipated terms of the notes being offered, the completion, timing and size of the proposed offerings and the intended use of the proceeds. Forward-looking statements represent Progenity's current expectations regarding future events and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those implied by the forward-looking statements. Among those risks and uncertainties are market conditions, including market interest rates, the trading price and volatility of Progenity's common stock and risks relating to Progenity's business, including those described in periodic reports that Progenity files from time to time with the SEC. Progenity may not consummate the proposed offerings described in this press release and, if the proposed offerings are consummated, cannot provide any assurances regarding the final terms of the offer or the notes or its ability to effectively apply the net proceeds as described above. The forward-looking statements included in this press release speak only as of the date of this press release, and Progenity does not undertake to update the statements included in this press release for subsequent developments, except as may be required by law.

    Contact Information

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com 

    (858) 457-2436 



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  45. SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it has commenced an underwritten public offering of $25 million of shares of its common stock. In addition, Progenity is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional $3.75 million of shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    In a separate…

    SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. ("Progenity") (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it has commenced an underwritten public offering of $25 million of shares of its common stock. In addition, Progenity is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional $3.75 million of shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

    In a separate press release, Progenity also announced today its intention to offer, in a separate, private offering to qualified institutional buyers, subject to market and other conditions, $75 million aggregate principal amount of convertible senior notes due 2025 (the "notes"), plus up to an additional $15 million aggregate principal amount of notes that the initial purchaser of the notes has the option to purchase from Progenity. The completion of the offering of common stock is not contingent on the completion of the offering of the notes, and the completion of the offering of notes is not contingent on the completion of offering of common stock. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any notes or any shares of common stock issuable upon conversion of the notes.

    Piper Sandler & Co. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering of common stock. BTIG, LLC is acting as the lead manager for the offering of common stock.

    A registration statement relating to the offering of common stock has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This offering is being made only by means of a prospectus, copies of which may be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at (800) 326-5897 or email a request to cmclientsupport@wellsfargo.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including, but not limited to, Progenity's expectations regarding the proposed offerings are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Progenity's actual results to differ materially from the forward-looking statements expressed or implied in this press release, the uncertainties related to market conditions and the completion of the offerings on the anticipated terms or at all, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of regulatory filings, and other matters, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of Progenity's products, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents filed with the SEC. Progenity claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619-743-6294)



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  46. SAN DIEGO, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products in women's health is pleased to announce the company has reported clinical verification data for its Preecludia™ preeclampsia rule-out laboratory-developed test currently in development. With its performance data, including an observed 98.2% NPV, Progenity believes the Preecludia test has the potential to become the first tool of its kind in the United States to help triage possible preeclampsia, a potentially deadly condition for both pregnant mothers and their babies.

    Preeclampsia is the second most common cause of maternal mortality…

    SAN DIEGO, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products in women's health is pleased to announce the company has reported clinical verification data for its Preecludia™ preeclampsia rule-out laboratory-developed test currently in development. With its performance data, including an observed 98.2% NPV, Progenity believes the Preecludia test has the potential to become the first tool of its kind in the United States to help triage possible preeclampsia, a potentially deadly condition for both pregnant mothers and their babies.

    Preeclampsia is the second most common cause of maternal mortality, and more than 700,000 women present each year with signs and symptoms of possible preeclampsia. It is characterized as a hypertensive disorder, but it is difficult to differentiate from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Ultimately, left undiagnosed and improperly managed, preeclampsia can result in impaired organ function, seizures, stroke, and death in the mother, and may require pre-term delivery of the baby. This can result in both poor health outcomes and significant costs. The total available U.S. market for a high NPV rule-out test for preeclampsia is forecasted at up to $3 billion, and there is also a large potential global opportunity.

    The Preecludia test is being developed to serve as a potential triage and rule-out test to help providers differentiate between patients with symptoms who are at risk for preeclampsia. This proprietary test is a multi-analyte protein biomarker assay which is designed to be run from a simple blood draw. In the prospective, blinded PRO-129 clinical verification study, samples were collected and analyzed from over 400 pregnant women with substantial diversity, gathered from 24 U.S. clinical sites comprised of predominantly OBGYN and Maternal Fetal Medicine (MFM) practices. Subjects presented with possible signs and symptoms of preeclampsia, including new onset hypertension, but no clear diagnosis. Subject data were independently adjudicated by a third party, and subjects, for whom preeclampsia was not diagnosed at the time of enrollment, were followed longitudinally through delivery. In subjects sampled up to 37 weeks' gestational age, the Preecludia test showed an 88.0% sensitivity, 73.3% specificity, and NPV of 98.2% at a 10% prevalence to rule out a patient's risk of developing preeclampsia within the next 14 days from the date of specimen collection. These data were generally consistent with previous results observed in the test's feasibility and optimization studies.

    "The Preecludia test is the first of its kind in the United States designed to help physicians better triage symptomatic patients with suspected preeclampsia," said Harry Stylli, PhD, CEO, chairman, and co-founder of Progenity. "It is tragic that we continue to use 19th century tools to evaluate pregnant women for diseases in the 21st century. We believe there is an obvious unmet need for new and better tools to aid in the triage, diagnosis, and management of preeclampsia. This milestone represents an important step toward our objective to commercialize the Preecludia test in the second half of 2021 and satisfy that unmet need."



    Progenity previously announced the successful completion of analytical verification, which evaluated the accuracy, precision, and stability of the test's biomarker assays. The final planned step in the development program is completion of the clinical validation study. The company has already collected over 3,000 samples from more than 1,700 patients enrolled in the PRO-104 validation study, and this study is expected to begin in Q1 2021.

    Progenity will provide a thorough review of preeclampsia, its cost to the healthcare system, and the Preecludia test development program during a Preeclampsia R&D Day presentation on November 20, 2020, from 8-10 AM Pacific. For further information or to access the slides presented, please visit: progenity.com/presentations.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements," which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements the development progress of our preeclampsia rule-out test, its future use by providers to rule out preeclampsia, the performance of the rule-out test in an upcoming validation study, the completion of our upcoming validation study, and our efforts and intent to commercialize the Preecludia test and address an unmet medical need. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products, the size and growth potential of the markets for our products, and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the outcome of pending and future investigations and legal proceedings, the loss or retirement of key scientific or management personnel, our ability to develop and maintain our corporate infrastructure, including maintaining effective internal controls, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 11, 2020, and other subsequent documents we file with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    IR@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619) 743-6294



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  47. SAN DIEGO, Nov. 17, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, will be presenting at the San Antonio Breast Cancer Virtual Symposium (SABCS) set to take place December 8-11, 2020.

    The data presented will be a part of the event's Spotlight Session Poster Presenters. Details of the presentation are as follows:

    Title - Describing the cancer spectrum in families with CHEK2 pathogenic and likely pathogenic variants by mutation type
    Authors - Julia G Moroney, MS, CGC, and Michele S. Basiliere, MS, CGC
    Poster number - PS8-18
    Date and time - Wednesday, December 9, 2020: 8:00 AM CT

    SABCS anticipates publishing…

    SAN DIEGO, Nov. 17, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, will be presenting at the San Antonio Breast Cancer Virtual Symposium (SABCS) set to take place December 8-11, 2020.

    The data presented will be a part of the event's Spotlight Session Poster Presenters. Details of the presentation are as follows:

    Title - Describing the cancer spectrum in families with CHEK2 pathogenic and likely pathogenic variants by mutation type

    Authors - Julia G Moroney, MS, CGC, and Michele S. Basiliere, MS, CGC

    Poster number - PS8-18

    Date and time - Wednesday, December 9, 2020: 8:00 AM CT

    SABCS anticipates publishing abstracts in late November 2020 and posters on December 9, 2020. The poster presentation will also be made available on the Progenity website following the conference.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (619)743-6294



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  48. SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, will participate in a fireside chat at the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.

    The pre-recorded fireside chat will be accessible beginning November 23, 2020 by visiting progenity.com/presentations. The recording will be available on the Progenity website through December 3, 2020.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and…

    SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, will participate in a fireside chat at the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.

    The pre-recorded fireside chat will be accessible beginning November 23, 2020 by visiting progenity.com/presentations. The recording will be available on the Progenity website through December 3, 2020.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    media@progenity.com

    (858) 457-2436



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  49. SAN DIEGO, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will host a Preeclampsia Virtual R&D Day on November 20, 2020 from 11 a.m. to 1 p.m. ET (8 a.m. to 10 a.m. PT). Members of Progenity's senior management team and select guest speakers will provide an in-depth discussion of the company's ongoing clinical development of the Preecludia™ rule-out test for preeclampsia. Attendees will learn about the pathophysiology of preeclampsia, current clinical management and diagnosis of the condition, its health economic burden, and Progenity's diagnostic approach.

    Interested parties…

    SAN DIEGO, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will host a Preeclampsia Virtual R&D Day on November 20, 2020 from 11 a.m. to 1 p.m. ET (8 a.m. to 10 a.m. PT). Members of Progenity's senior management team and select guest speakers will provide an in-depth discussion of the company's ongoing clinical development of the Preecludia™ rule-out test for preeclampsia. Attendees will learn about the pathophysiology of preeclampsia, current clinical management and diagnosis of the condition, its health economic burden, and Progenity's diagnostic approach.

    Interested parties may access a live audio webcast and slides of the presentations on the investor section of Progenity's website at progenity.com/presentations. Additionally, the live event may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 1190518. A replay of the webcast will be available shortly after the event and can be viewed at the same web link.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436



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  50. Reported 84 thousand tests in the third quarter, up 12% compared to the second quarter

    Achieved a preeclampsia test analytical verification milestone

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided corporate updates and reported financial results for the third quarter ended September 30, 2020.

    Progenity made significant progress during the third quarter, both with its revenue generating business and especially with its innovation pipeline programs. The company continued to grow its overall…

    Reported 84 thousand tests in the third quarter, up 12% compared to the second quarter

    Achieved a preeclampsia test analytical verification milestone

    Management will host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT

    SAN DIEGO, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today provided corporate updates and reported financial results for the third quarter ended September 30, 2020.

    Progenity made significant progress during the third quarter, both with its revenue generating business and especially with its innovation pipeline programs. The company continued to grow its overall volume demand and increased its in-network position by adding national and regional contracts, and saw additional commercial and government payors covering average risk NIPT. The company also announced it had secured additional COVID-19 testing capacity in order to meet anticipated higher demand for the test ahead of the winter season.

    On the innovation front, the company announced it successfully achieved a preeclampsia test analytical verification milestone, with the program now transferred to the operations group which will be responsible for both validation and full commercialization of the test in 2021.

    "We continue to make progress in establishing a strong foundation with our core molecular testing business and anticipate these efforts to translate into stronger and consistent operating performance near term. We are particularly excited with the progress and transformational potential of our R&D pipeline and look forward to our upcoming preeclampsia R&D day for investors on November 20, 2020," said Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity.

    Third Quarter 2020 Results and Other Corporate Highlights

    • Reported approximately 84 thousand tests in the third quarter, up 12% compared to the second quarter including COVID-19 test volume.



    • Increased in-network covered lives with the addition of the Multiplan national contract, providing access to up to 60 million lives and added 1.5 million lives from additional regional payors.



    • Secured a substantial increase in its COVID-19 PCR testing capacity and supply chain access through its existing relationship with ThermoFisher.



    • Successfully achieved a key milestone in the analytical verification phase of the LDT version of the Preecludia™ preeclampsia test. The company also announced an upcoming preeclampsia R&D day for November 20, 2020.



    • Announced encouraging preclinical data supporting the potential of the Company's oral drug delivery system (DDS) using a proprietary autonomous localization technology designed to identify the ileal/ileocecal region of the GI tract in targeting the colon for drug delivery.



    • Received a $15.7 million tax refund related to the 2019 net operating loss (NOL) carryback provisions available under the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) legislation, a majority of which was used to make accelerated payments to the government under our government settlement agreements.

    Third Quarter 2020 Financial Results

    Comparison of Three Months Ended September 30, 2020 and June 30, 2020

    Revenue was $25.9 million in the three months ended September 30, 2020, up from $17.3 million in the three months ended June 30, 2020. The second quarter revenues reflected a $10.3 million accrual for refunds to government payors.

    Total accessioned tests volume, which includes the company's Innatal, Preparent, Riscover and COVID-19 testing, was 84,067 in the third quarter of 2020, up by 12% compared to the accessioned tests volume in the second quarter of 2020, which was 75,017 tests.

    Gross margin was 9.2% for the three months ended September 30, 2020, compared to negative 26.5% for the three months ended June 30, 2020, which primarily reflected the effect of revenue reduction related to refund accrual in the second quarter.

    Operating expenses were $46.9 million for the three months ended September 30, 2020, compared to $42.2 million in the three months ended June 30, 2020.

    Net loss attributable to common stockholders was $47.1 million for the three months ended September 30, 2020 and basic and diluted net loss per share was $1.01, compared to a net loss attributable to common stockholders of $53.1 million and a net loss per share of $6.11 for the three months ended June 30, 2020.

    Comparison of Three Months Ended September 30, 2020 and 2019

    Revenue was $25.9 million in the three months ended September 30, 2020, compared to $18.8 million in the three months ended September 30, 2019.

    Gross margin was 9.2% for the three months ended September 30, 2020, compared to negative 33.2% for the three months ended September 30, 2019.

    Operating expenses were $46.9 million for the three months ended September 30, 2020, compared to $48.6 million in the three months ended September 30, 2019.

    Net loss attributable to common stockholders was $47.1 million for the three months ended September 30, 2020 and basic and diluted net loss per share was $1.01, compared to a net loss of $97.9 million and a net loss per share of $19.85 for the three months ended September 30, 2019.

    Cash and cash equivalents were $60.0 million as of September 30, 2020. As of September 30, 2020, Progenity had 47.0 million shares outstanding.

    COVID-19 Update

    Public health measures related to the novel coronavirus are greatly impacting healthcare practices. We have responded to the COVID-19 pandemic by implementing and maintaining robust response plans, seamlessly continuing laboratory operations and maintaining pre-pandemic turnaround times. We enhanced our digital sales and support capabilities, increased proactive test reporting and remote genetic counseling capabilities, and expanded our mobile phlebotomy services, assisting our customers to continue serving their patients with the same quality care.

    Webcast and Conference Call Information

    Progenity will host a webcast and conference call to discuss the second quarter financial results and answer investment community questions today, Monday, November 9, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 5878610. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the impact of the COVID-19 pandemic on our business, operations, financial results, and future performance, and the progress of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, the ongoing COVID-19 pandemic, our ability to develop and commercialize our testing products as well as innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding future test volumes, our expectations regarding our in network position, anticipated capacity for our tests, and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 to be filed with the SEC and other subsequent documents we file with the SEC.

    Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436

    Progenity, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

     Three Months Ended 
     September 30, 2020  June 30, 2020 
    Revenues$25,943  $17,266 
    Cost of sales 23,601   21,835 
    Gross profit (loss) 2,342   (4,569)
    Operating expenses:       
    Research and development 13,043   12,234 
    Selling and marketing 13,244   12,736 
    General and administrative 20,626   17,181 
    Total operating expenses 46,913   42,151 
    Loss from operations (44,571)  (46,720)
    Interest expense (2,476)  (2,507)
    Interest and other income (expense), net (18)  (3,556)
    Loss before income taxes (47,065)  (52,783)
    Income tax benefit     
    Net loss (47,065)  (52,783)
    Dividend paid to preferred stockholders    (268)
    Net loss attributable to common stockholders$(47,065) $(53,051)
    Net loss per share attributable to common stockholders, basic and diluted$(1.01) $(6.11)
    Weighted average number of shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted 46,632,043   8,687,250 
     



    Progenity, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except share and per share amounts)

     Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
     2020  2019  2020  2019 
    Revenues$25,943  $18,772  $60,037  $123,509 
    Cost of Sales 23,601   24,997   72,006   75,531 
    Gross profit (loss) 2,342   (6,225)  (11,969)  47,978 
    Operating Expenses:               
    Research and development 13,043   17,080   36,517   48,791 
    Selling and marketing 13,244   15,263   40,416   45,510 
    General and administrative 20,626   16,273   54,915   44,823 
    Total operating expenses 46,913   48,616   131,848   139,124 
    Loss from operations (44,571)  (54,841)  (143,817)  (91,146)
    Interest expense (2,476)  (2,321)  (7,285)  (6,872)
    Interest and other income (expense), net (18)  29   (3,594)  457 
    Loss before income taxes (47,065)  (57,133)  (154,696)  (97,561)
    Income tax benefit       (37,696)   
    Net loss (47,065)  (57,133)  (117,000)  (97,561)
    Dividend paid to preferred shareholders       (268)  (3,652)
    Stock dividend on exchange of Series A-1 to Series B Preferred Stock    (27,637)     (27,637)
    Stock dividend on Series B Preferred Stock    (13,137)     (13,137)
    Net loss attributable to common shareholders$(47,065) $(97,907) $(117,268) $(141,987)
    Net loss per share attributable to common shareholders, basic and diluted$(1.01) $(19.85) $(5.80) $(29.27)
    Weighted average number of shares outstanding used in calculating net loss per share, basic and diluted 46,632,043   4,931,204   20,201,325   4,851,603 
     

    Progenity, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)

     September 30,

    2020
      December 31,

    2019
     
         (1) 
    Assets       
    Current assets:       
    Cash and cash equivalents$60,013  $33,042 
    Accounts receivable, net 13,425   22,189 
    Inventory 10,383   10,937 
    Income tax receivable    634 
    Prepaid expenses and other current assets 9,216   7,846 
    Total current assets 93,037   74,648 
    Property and equipment, net 16,088   15,891 
    Goodwill and other intangible assets 10,294   10,990 
    Other assets 198   198 
    Total assets$119,617  $101,727 
    Liabilities and Stockholders' Deficit       
    Current liabilities:       
    Accounts payable$15,666  $15,754 
    Accrued expenses and other current liabilities 71,013   83,615 
    Current portion of mortgages payable and capital lease obligations 667   968 
    Total current liabilities 87,346   100,337 
    Mortgages payable and capital lease obligations, net of current portion 2,961   3,439 
    Note payable to related party, net 69,642   68,966 
    Other long-term liabilities 20,088   12,859 
    Total liabilities$180,037  $185,601 
    Stockholders' deficit:       
    Common stock 50   9 
    Series A Preferred Stock    4 
    Series B Preferred Stock    102 
    Additional paid-in capital 424,047   283,260 
    Accumulated deficit (465,746)  (348,478)
    Treasury stock (18,771)  (18,771)
    Total stockholders' deficit (60,420)  (83,874)
    Total liabilities and stockholders' deficit$119,617  $101,727 

    ____________

          (1)   The condensed, consolidated balance sheet at December 31, 2019 has been derived from the audited consolidated financial statements

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  51. SAN DIEGO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, is pleased to announce positive preliminary preclinical data regarding the performance of its oral drug delivery system (DDS). The DDS capsule uses a proprietary autonomous localization technology designed to identify the ileal/ileocecal region of the GI tract. Because the DDS localization technology is based on anatomy, it is designed to resist variability in physiological conditions like pH, motility and bacteria.

    The study consisted of administration of a fully functional DDS device containing a mixture of acetaminophen and sulfasalazine…

    SAN DIEGO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, is pleased to announce positive preliminary preclinical data regarding the performance of its oral drug delivery system (DDS). The DDS capsule uses a proprietary autonomous localization technology designed to identify the ileal/ileocecal region of the GI tract. Because the DDS localization technology is based on anatomy, it is designed to resist variability in physiological conditions like pH, motility and bacteria.

    The study consisted of administration of a fully functional DDS device containing a mixture of acetaminophen and sulfasalazine in a canine animal model. The study endpoints were device function as determined by evaluation of the data from the recovered capsules and the pharmacokinetic (PK) results of the acetaminophen and 5-aminosalicylate drug products delivered using the DDS. When ingested orally, acetaminophen is typically absorbed rapidly along the entire length of the GI tract, while sulfasalazine is a prodrug that is metabolized by intestinal bacteria, resulting in the release of sulfapyridine and 5-aminosalicylate mainly in the large intestine where bacterial concentration is elevated. Progenity is pleased to report that all devices met the study endpoints, and the PK results suggest that drug was released in the large intestine. In addition, no adverse events were observed.



    "Ulcerative colitis is poorly managed with current therapeutics, in part due to the inability to get sufficient drug concentrations at the site of disease without side effects. We believe the DDS platform and PGN-001 and PGN-600 have the potential to significantly improve patient outcomes by producing high drug concentrations locally at the site of disease to improve efficacy while limiting systemic exposure to ensure safety," said William Sandborn MD, Chief of the Division of Gastroenterology and Director of the Inflammatory Bowel Disease Center at the University of California San Diego.



    Progenity has two lead drug-device candidates utilizing the DDS technology, PGN-001, a high-concentration formulation of adalimumab, and PGN-600 a liquid formulation of tofacitinib, both under development for the treatment of ulcerative colitis. The company has previously observed through intracecal catheter preclinical colitis models, which are designed to mimic the localized delivery of the DDS, both local delivery of drug product and reduction in systemic exposure when compared to injection.

    "These exciting data provide pre-clinical evidence that the DDS platform performed as intended and accurately targeted the colon. The technology is also designed to allow for delivery of different formulations, enabling further evaluation of formulations designed to improve stability, colonic coverage and tissue uptake. We expect to evaluate the function of the DDS in normal healthy human volunteers in the first quarter of 2021," said Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress of our research and development efforts, expectations regarding the timing of future clinical trials, our potential impact on patient outcomes are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to innovate in the field of precision medicine, the size and growth potential of the markets for our products, and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, the performance of third parties in connection with the commercialization and development of our products, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others and those described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the U.S. Securities and Exchange Commission (SEC) and other subsequent documents we file with the SEC. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Until the final settlement agreements are approved and signed by the states, there can be no assurance that the amount we have accrued will be sufficient to cover Progenity's obligations relating to this matter. Progenity's obligations could also increase, potentially materially, depending on a number of factors including whether or not the agreement on the monetary terms with the states is finalized, whether an individual state or states opt out of the settlement prior to approval in order to pursue a separate action or resolution, the terms of the final approved agreements and the parties to the settlement. For additional information, please see Note 9. Commitments and Contingencies to Progenity's audited financial statements for the year ended December 31, 2019, in the Registration Statement, as well as "Risk Factors—Regulatory Risks Related to Our Business—If we or our commercial partners act in a manner that violates healthcare laws or otherwise engage in misconduct, we could face substantial penalties and our business operations, and financial condition could be adversely affected."

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    IR@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (619) 743-6294

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  52. SAN DIEGO, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report third quarter 2020 financial results on Monday, November 9, 2020 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 5878610. A live webcast and archive of the call will be available online from the investor…

    SAN DIEGO, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report third quarter 2020 financial results on Monday, November 9, 2020 after the close of financial markets. Progenity's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 833-519-1237 for domestic callers and 914-800-3810 for international callers and entering the conference code: 5878610. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.progenity.com.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436

    Primary Logo

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  53. Announces Expansion of its COVID-19 Testing Offering

    Provides Preliminary Third Quarter 2020 Financial Update

    SAN DIEGO, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced a key achievement in the verification of its preeclampsia rule-out test, a significant milestone demonstrating the robustness of the underlying assays and the clinical performance of the Laboratory Developed Test in its CLIA laboratory in Ann Arbor.

    Preeclampsia Rule-out Test Analytical Verification Milestone Achieved

    The company confirmed it had validated all its key operational methods, including analytical…

    Announces Expansion of its COVID-19 Testing Offering

    Provides Preliminary Third Quarter 2020 Financial Update

    SAN DIEGO, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced a key achievement in the verification of its preeclampsia rule-out test, a significant milestone demonstrating the robustness of the underlying assays and the clinical performance of the Laboratory Developed Test in its CLIA laboratory in Ann Arbor.

    Preeclampsia Rule-out Test Analytical Verification Milestone Achieved

    The company confirmed it had validated all its key operational methods, including analytical accuracy, analytical precision, analytical sensitivity, analytical specificity, linearity, and stability of the assays. "We're very excited to report the achievement of this key milestone in the development of our preeclampsia rule out test and are confident the underlying assays are robust and will assess the true biological responses associated with preeclampsia. The clinical verification cohort continues to be analyzed but headline performance was consistent with prior observations with our feasibility and optimization clinical cohorts. Moreover, we observed a longevity of the rule-out result we believe should enable effective integration into existing clinical care paths. We are looking forward to the initiation of the key clinical validation phase, for which samples have already been collected," said Matthew Cooper, PhD, MBA, Chief Scientific Officer of Progenity.

    Harry Stylli, PhD, CEO, chairman of the board and co-founder of Progenity added, "We are also continuing to engage with the FDA regarding the IVD version of the test and recently had a productive pre-submission meeting with the Agency on our development path and we are happy with their guidance. We're looking forward to sharing more information, including an FDA update and data from the verification studies, during an upcoming preeclampsia R&D day scheduled for November 20, 2020. At the R&D day, we and our advisors will review and discuss our program and illustrate how we intend to fulfill the current clinical unmet need and help healthcare providers and patients better manage this debilitating syndrome. This significant opportunity represents a potential $3 billion US total market that we intend to access with our innovative test."

    Expansion of COVID-19 PCR Test Offering

    The company announced it has secured a substantial increase in its COVID-19 PCR testing capacity to more than 750,000 tests per annum and supply chain access through its existing relationship with ThermoFisher, in order to meet the high demand for the test ahead of the winter season, and expects to begin a gradual expansion of its commercial testing offering nationally beginning mid-November.

    "Presently, 97% of our COVID-19 tests are resulted within 24 hours from receiving samples, which meets the new government mandate for higher reimbursement rates," Dr. Stylli continued, "While this test offering is complementary to Progenity's core women's health business, it fulfills an important unmet need as demand currently outpaces supply for COVID testing within the turnaround window, and this service is designed to satisfy both our higher risk OBGYN/MFM patients as well as broader national demand for COVID-19, flu and respiratory virus testing."

    Preliminary Third Quarter 2020 Revenue and Test Volume

    Based on preliminary financial information, Progenity expects to report revenue for the third quarter of 2020 in a range of approximately $25 to $26 million, compared to reported revenue of $17.1 million in the second quarter of 2020. Progenity's reported test volume for the third quarter of 2020 was more than 84 thousand tests compared to approximately 75 thousand tests in the second quarter of 2020, representing a 12% quarter over quarter increase.

    "We're still very much in the early phase of benefitting from improvement to our revenue cycle management processes but anticipate these initiatives will begin to contribute more evidently to revenue in the fourth quarter of 2020 and explicitly in 2021," said Dr. Stylli. "We are making significant progress with our innovation pipeline as illustrated by this week's ACG PILDx and preeclampsia rule-out test announcements, and we expect to provide further updates with regard to our Innatal4 program as well as our GI Precision Medicine pipeline in the near future."

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    COVID-19 Update

    Public health measures related to the novel coronavirus are greatly impacting healthcare practices. We have responded to the COVID-19 pandemic by implementing and maintaining robust response plans, seamlessly continuing laboratory operations and maintaining pre-pandemic turnaround times. We enhanced our digital sales and support capabilities, increased proactive test reporting and remote genetic counseling capabilities, and expanded our mobile phlebotomy services, assisting our customers to continue serving their patients with the same quality care.

    Preliminary Financial Information

    The preliminary revenue estimate presented above is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. This preliminary estimate is based solely upon information available to management as of the date of this press release. However, the Company has not completed its financial closing procedures for the three months ended September 30, 2020, and its actual results could vary materially from this preliminary revenue estimate. In addition, the Company's independent registered public accounting firm has not reviewed this information or completed its review procedures for the quarter ended September 30, 2020 and does not express an opinion or any other form of assurance with respect to this preliminary revenue estimate or its achievability. During the course of the preparation of the Company's consolidated financial statements and related notes as of and for the three months ended September 30, 2020, the Company and its auditors may identify items that would require the Company to make material adjustments to the preliminary estimates presented above. As a result, investors should exercise caution in relying on this information and should not draw any inferences from this information regarding financial or operating data not provided. This preliminary revenue estimate should not be viewed as a substitute for full financial statements prepared in accordance with GAAP. In addition, this preliminary revenue estimate is not necessarily indicative of the results to be achieved in any future period. Investors are cautioned not to place undue reliance on such preliminary estimates. Investors should read the Company's unaudited consolidated financial statements and the notes thereto for the three months ended September 30, 2020 once they become available.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the preliminary results for the quarter ended September 30, 2020, the impact of the COVID-19 pandemic on our business, operations, financial results, and future performance, the impact of the improvements in our revenue cycle management process, the progress of our in-network transition, the development progress of our preeclampsia rule-out test, increases in our COVID-19 testing capacity, plans for future test offerings, the sufficiency of our capital, the resiliency of our business, and the progress of our research and development efforts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "preliminary," "expect," "expected," "estimate," or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, the ongoing COVID-19 pandemic and associated shelter-in-place orders, our ability to develop and commercialize our testing products as well as innovate in the field of precision medicine, the size and growth potential of the markets for our products, and our ability to serve those markets, the rate and degree of market acceptance and clinical utility of our products and coverage and rates of reimbursement for our products, the performance of third parties in connection with the commercialization and development of our products, including third-party suppliers for COVID-19 assays, regulatory developments in the United States and foreign countries, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our ability to improve and enhance our products, our plans to research, develop, and commercialize new products, the development, regulatory approval, efficacy, and commercialization of competing products, the outcome of pending and future investigations and legal proceedings, the loss or retirement of key scientific or management personnel, our ability to develop and maintain our corporate infrastructure, including maintaining effective internal controls, our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others, our compliance with the terms and conditions of our corporate integrity agreement, potential overpayment obligations and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Registration Statement on Form S-1 (File No. 333-238738), as amended, filed with the U.S. Securities and Exchange Commission, Progenity's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 14, 2020, and other subsequent documents we file with the SEC.

    Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436

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  54. SAN DIEGO, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products and innovation in the field of gastrointestinal precision medicine, is pleased to announce an oral presentation, which was awarded the Category Award (Small Intestine), and a poster, both related to the Progenity Ingestible Laboratory Diagnostics (PIL Dx) capsule in SIBO, which are presented at the American College of Gastroenterology (ACG) virtual annual meeting taking place October 23-28, 2020. The data in these presentations demonstrate the achievement of critical de-risking steps in Progenity's progress toward novel approaches for the…

    SAN DIEGO, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products and innovation in the field of gastrointestinal precision medicine, is pleased to announce an oral presentation, which was awarded the Category Award (Small Intestine), and a poster, both related to the Progenity Ingestible Laboratory Diagnostics (PIL Dx) capsule in SIBO, which are presented at the American College of Gastroenterology (ACG) virtual annual meeting taking place October 23-28, 2020. The data in these presentations demonstrate the achievement of critical de-risking steps in Progenity's progress toward novel approaches for the assessment, diagnosis, and future treatment of gastrointestinal diseases through ingestible capsule devices.

    Small intestinal bacterial growth (SIBO) is an abnormal overgrowth of bacteria in the small bowel, with signs and symptoms that overlap with other gastrointestinal diseases leading to over 100 million patient visits in the US annually. Current diagnostic methods are invasive or inaccurate, which often leads to empiric use of antibiotics without a clear diagnosis.

    PIL Dx is an ingestible capsule with a built-in assay and a fluorescent spectrophotometer designed to achieve targeted localization, collect and analyze intestinal fluid samples, and transmit data in real time, without a need to recover the capsule. As such, PIL Dx represents a promising alternative for diagnosing SIBO, and eventually, other difficult-to-diagnose GI disorders.

    The oral presentation by renowned gastroenterologist Dr. Satish Rao, MD, PhD, FACG highlights results of a multi-site study of 66 subjects in which a benchtop version of the Progenity SIBO assay showed 94% agreement with the current standard of endoscopic aspiration and total bacterial count. "I am very pleased with the results of our collaborative research. Our data highlight the potential for innovative technologies, such as those being developed by Progenity, to advance the field and provide less invasive, yet accurate tools to diagnose SIBO," said Dr. Rao. "The studies showcased at ACG indicate promising progress towards ingestible, autonomous assays that could one day become a gold standard in GI diagnostics, where today, none exist."

    The poster presentation showcases physician research and expert analysis of the need for a novel SIBO diagnostic and a clear physician preference for the PIL Dx product concept over existing testing options.

    "The enthusiastic reception of these data by the GI community points to the clear unmet need for new tools to better diagnose and differentiate SIBO from other gastrointestinal disorders.  Our PIL Dx technology—a digital laboratory in a capsule—promises to provide a simple, more rapid, and relatively non-invasive solution, with accuracy comparable to current reference standards," said Harry Stylli, PhD, CEO, chairman and co-founder of Progenity. "These studies represent the achievement of a critical milestone as we continue to advance our PIL Dx platform towards preclinical and clinical studies in 2021, and ultimately to commercialization. Our goal is to offer true precision medicine by combining novel diagnostics and therapeutic solutions."

    Presentation details are below:

    Evaluation of Smart Capsule Bacterial Detection System (SCBDS) assay and duodenal culture in subjects suspected of SIBO and undergoing upper endoscopy: Interim analysis

    Presenting Author:Satish Rao, MD, PhD, Professor of Medicine, Medical College of Georgia at Augusta University
    Abstract ID:S1282
      
    SIBO Diagnosis: Clinical Survey of Practice Patterns, Unmet Needs, and Perception of a Novel Ingestible Diagnostic Capsule
    Presenting Author:Baharak Moshiree, MD, MSc, Professor of Medicine, Atrium Health, University of North Carolina
    Poster Number:P1144 (S0507)

    The abstracts and presentations are available to view on demand through the ACG virtual annual meeting website, as well as on the Progenity website following the meeting.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit www.progenity.com.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and timing of our research and development efforts, including clinical trials, and the timing for regulatory approvals are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Company's actual results to differ materially from the forward-looking statements expressed or implied in this press release, including those described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the U.S. Securities and Exchange Commission. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    IR@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

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  55. SAN DIEGO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, is pleased to announce that two abstracts related to Progenity's ingestible technologies for the diagnosis and treatment of gastrointestinal disorders have been accepted for presentation at American College of Gastroenterology (ACG) virtual annual meeting set to take place October 23-28, 2020. Progenity will be presenting one oral presentation and one poster presentation.

    The accepted abstract titles and study findings will be a part of the event's on-demand sessions and virtual e-poster hall, which are embargoed until October 26 at 8:00…

    SAN DIEGO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, is pleased to announce that two abstracts related to Progenity's ingestible technologies for the diagnosis and treatment of gastrointestinal disorders have been accepted for presentation at American College of Gastroenterology (ACG) virtual annual meeting set to take place October 23-28, 2020. Progenity will be presenting one oral presentation and one poster presentation.

    The accepted abstract titles and study findings will be a part of the event's on-demand sessions and virtual e-poster hall, which are embargoed until October 26 at 8:00 a.m., EST, to coincide with the start of the ACG 2020 Virtual Annual Scientific Meeting. More information about these abstracts will be made available on the Progenity website following the conference.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (619)743-7294

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  56. SAN DIEGO, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced support for the Preeclampsia Foundation's recent call to action advocating for accelerating the development and clinical adoption of biomarker tests for the diagnosis of preeclampsia, a life-threatening hypertensive disorder of pregnancy. The foundation issued its call to action urging the life science community and policy makers to accelerate the development and adoption of biomarker-based testing for preeclampsia.

    "We support the Preeclampsia Foundation both in their mission and in their call for accurate testing for preeclampsia…

    SAN DIEGO, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced support for the Preeclampsia Foundation's recent call to action advocating for accelerating the development and clinical adoption of biomarker tests for the diagnosis of preeclampsia, a life-threatening hypertensive disorder of pregnancy. The foundation issued its call to action urging the life science community and policy makers to accelerate the development and adoption of biomarker-based testing for preeclampsia.

    "We support the Preeclampsia Foundation both in their mission and in their call for accurate testing for preeclampsia," said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity. "The need is urgent because, while preeclampsia rates are continuing to rise, healthcare providers today are still evaluating symptoms and risk using technology from the late 1800s. We are demonstrating our commitment to this cause by investing in the development of a biomarker-based test that is currently in an advanced stage of development. This test, which is potentially the first of its kind, could bring more personalized care to aid in the diagnosis and treatment of preeclampsia."

    Preeclampsia occurs in 5 to 8% of pregnancies and is a leading cause of preterm birth and maternal and infant death. A progressive condition that can occur during the third trimester of pregnancy, preeclampsia is typically characterized by elevated blood pressure, edema (swelling in hands or face), and protein in the urine. The cause of preeclampsia is not fully understood and involves multiple pathophysiologic pathways. It is estimated that over 700,000 pregnant women in the United States experience signs or symptoms that could be attributed to preeclampsia each year, but symptoms can be difficult to differentiate from those of other hypertensive disorders of pregnancy. Healthcare providers in the United States are primarily equipped with non-specific tools developed over 100 years ago to diagnose this potentially deadly condition.  

    Progenity is currently developing a novel biomarker blood test designed to rule out preeclampsia in symptomatic women during the third trimester. This objective risk assessment tool is designed to help healthcare providers differentiate between preeclampsia and other, lower-risk hypertensive disorders. By identifying patients who are not at risk for developing preeclampsia, the test could enable healthcare providers to better guide patient care and maintain pregnancies to term when possible. This will potentially lead to fewer unnecessary hospitalizations and preterm deliveries in this patient population, while providing added reassurance for patients.

    To lend support to the Preeclampsia Foundation's call to action, clinicians, researchers and patients are encouraged to sign their petition for change.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Safe Harbor Statement or Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the development of our preeclampsia rule-out test are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to develop and commercialize our preeclampsia rule-out test and those risks described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Progenity's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 14, 2020, and other subsequent documents we file with the SEC.

    Progenity expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (619)743-7294

     

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  57. SAN DIEGO, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will be added to the Russell 2000®  Index, effective when the U.S. market opens on Friday, September 18, 2020.

    The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity market. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider…

    SAN DIEGO, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will be added to the Russell 2000®  Index, effective when the U.S. market opens on Friday, September 18, 2020.

    The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity market. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436

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  58. SAN DIEGO, Sept. 02, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, is scheduled to participate in two upcoming virtual investor conferences:

    • A presentation at Baird's 2020 Global Healthcare Conference at 12:15 p.m. ET / 9:15 a.m. PT on September 9, 2020; and
    • An analyst-led group meeting at the 2020 Wells Fargo Virtual Healthcare Conference at 12:40 p.m. ET / 9:40 a.m. PT on September 10, 2020.

    A live audio webcast of the Baird presentation and the Wells Fargo group meeting will be available in the Investors…

    SAN DIEGO, Sept. 02, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ:PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that Harry Stylli, Ph.D., CEO, chairman of the board, and co-founder of Progenity, is scheduled to participate in two upcoming virtual investor conferences:

    • A presentation at Baird's 2020 Global Healthcare Conference at 12:15 p.m. ET / 9:15 a.m. PT on September 9, 2020; and
    • An analyst-led group meeting at the 2020 Wells Fargo Virtual Healthcare Conference at 12:40 p.m. ET / 9:40 a.m. PT on September 10, 2020.

    A live audio webcast of the Baird presentation and the Wells Fargo group meeting will be available in the Investors section of Progenity's website at https://www.progenity.com, with an archived replay available following the events.

    About Progenity

    Progenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenity's vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For additional information about Progenity, please visit the company's website at www.progenity.com.

    Investor Contact:

    Robert Uhl

    Managing Director, Westwicke ICR

    ir@progenity.com

    (619) 228-5886

    Media Contact:

    Kate Blom-Lowery

    CG Life

    kblomlowery@cglife.com

    (858) 457-2436

    Primary Logo

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  59. Avero Diagnostics, a physician-owned laboratory, is pleased to announce the expansion of its COVID-19 testing portfolio with the addition of the Roche Elecsys® Anti-SARS-CoV-2 antibody test. Serological testing supports the Centers for Disease Control and Prevention (CDC) efforts to more accurately understand how many people have been infected with SARS-CoV-2, the virus that causes COVID-19, and how it is spreading. This offering, available now, will complement Avero's existing COVID-19 molecular testing program, which Avero launched in May 2020 to support the diagnostic needs of area hospitals, health systems, multi-specialty family practices, urgent care centers, and county health departments.

    "As the medical and scientific communities…

    Avero Diagnostics, a physician-owned laboratory, is pleased to announce the expansion of its COVID-19 testing portfolio with the addition of the Roche Elecsys® Anti-SARS-CoV-2 antibody test. Serological testing supports the Centers for Disease Control and Prevention (CDC) efforts to more accurately understand how many people have been infected with SARS-CoV-2, the virus that causes COVID-19, and how it is spreading. This offering, available now, will complement Avero's existing COVID-19 molecular testing program, which Avero launched in May 2020 to support the diagnostic needs of area hospitals, health systems, multi-specialty family practices, urgent care centers, and county health departments.

    "As the medical and scientific communities work to understand and stop the spread of COVID-19, serological testing serves as a piece of the very complex puzzle," said Trae Mattison, MD, Managing Partner, Avero Diagnostics. "By expanding our COVID-19 testing services, we are not only supporting the need for serology testing in our community, we are also contributing to the national effort to understand the spread of the SARS-CoV-2 virus."

    A serological test, often called antibody testing, is used to determine whether a person may have had a past infection with the virus that causes COVID-19. This test uses a blood sample to provide qualitative detection of high-affinity antibodies to SARS-CoV-2, to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. This assay enriches detection of higher affinity antibodies which are more likely to be specific for SARS-CoV-2. While this assay in principle can detect antibodies of all isotypes (i.e., IgG, IgA, IgM), it preferentially detects IgG antibodies. This test is recommended for individuals 14 days post-symptom onset, or five to seven days following exposure to individuals with confirmed COVID-19.

    Avero Diagnostics' CLIA-certified and CAP-accredited laboratory is using the Roche immunoassay for the qualitative detection of antibodies against SARS-CoV-2. The test is an electro-chemiluminescence immunoassay with 99.8% specificity. Avero can initially process approximately 800 tests per day, with the potential to scale up capacity based on demand. Avero expects to provide results to ordering providers within 24 to 48 hours.

    For more information, visit www.averodx.com.

    About Avero Diagnostics

    Avero Diagnostics is a physician-owned laboratory and an affiliate of Progenity, Inc. (NASDAQ:PROG), dedicated to providing high quality anatomic pathology, molecular pathology, and genetic testing services to physicians and their patients. Avero Diagnostics provides sub-specialized pathology services in the areas