CHMA Chiasma Inc.

4.72
+0.21  (+5%)
Previous Close 4.51
Open 4.65
52 Week Low 2.88
52 Week High 9.25
Market Cap $199,462,824
Shares 42,265,341
Float 36,289,492
Enterprise Value $111,689,687
Volume 911,021
Av. Daily Volume 716,628
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Upcoming Catalysts

Drug Stage Catalyst Date
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Mycapssa - OPTIMAL
Acromegaly
Approved
Approved
FDA approval announced June 26, 2020.
Mycapssa
Acromegaly
CRL
CRL
CRL April 15 2016

Latest News

  1. NEEDHAM, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock and, to certain investors in lieu thereof, pre-funded warrants to purchase up to 5,000,000 shares of its common stock at an exercise price of $0.0001 per share. The public offering price of each share of common stock is $4.00 and the public offering price of each pre-funded warrant…

    NEEDHAM, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock and, to certain investors in lieu thereof, pre-funded warrants to purchase up to 5,000,000 shares of its common stock at an exercise price of $0.0001 per share. The public offering price of each share of common stock is $4.00 and the public offering price of each pre-funded warrant is $3.9999 per underlying share. In addition, Chiasma has granted the underwriters a 30-day option to purchase up to an additional 2,625,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. This offering is expected to close on or about July 6, 2020, subject to satisfaction of customary closing conditions.

    Jefferies, Piper Sandler & Co. and Cantor are acting as book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager for the offering.

    Chiasma expects to receive gross proceeds of $70 million, before deducting underwriting discounts and offering expenses (without giving effect to any exercise of the underwriters' option to purchase additional shares, if any). Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly; activities to support the planned submission of a marketing authorization application to the European Medicines Agency for regulatory approval of MYCAPSSA in the European Union for acromegaly, assuming positive data from the MPOWERED Phase 3 trial; early clinical development of one or more potential pipeline candidates using its TPE platform technology; and working capital and other general corporate purposes.

    The securities are offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233654), including a base prospectus, filed by Chiasma on September 18, 2019 and declared effective by the Securities and Exchange Commission, or the SEC, on September 25, 2019. The offering will be made only by means of a prospectus. A preliminary prospectus supplement related to the offering has been filed with the SEC and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at ; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 such state or jurisdiction.

    About Chiasma

    Chiasma is focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Chiasma's public offering, future expectations, plans and prospects for Chiasma. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law. 

    Corporate Contact:

    Dawn Schottlandt

    Vice President, Investor Relations and Corporate Communications

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  2. NEEDHAM, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced that it has commenced an underwritten public offering of its common stock, and, to certain investors in lieu thereof, pre-funded warrants to purchase shares of its common stock. In addition, Chiasma expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock plus the shares of common stock underlying the pre-funded warrants…

    NEEDHAM, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced that it has commenced an underwritten public offering of its common stock, and, to certain investors in lieu thereof, pre-funded warrants to purchase shares of its common stock. In addition, Chiasma expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock plus the shares of common stock underlying the pre-funded warrants sold in connection with the offering. All of the securities to be sold in the offering are to be sold by Chiasma. This offering is subject to market 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.

    Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly; activities to support the planned submission of a marketing authorization application to the European Medicines Agency for regulatory approval of MYCAPSSA in the European Union for acromegaly, assuming positive data from the MPOWERED Phase 3 trial; early clinical development of one or more potential pipeline candidates using its TPE platform technology; and working capital and other general corporate purposes.

    Jefferies, Piper Sandler, and Cantor Fitzgerald. are acting as book-running managers for the offering.

    The securities are offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233654), including a base prospectus, filed by Chiasma on September 18, 2019 and declared effective by the Securities and Exchange Commission, or the SEC, on September 25, 2019. The offering will be made only by means of a prospectus. A preliminary prospectus supplement related to the offering and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 such state or jurisdiction.

    About Chiasma

    Chiasma is focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Chiasma's anticipated public offering, future expectations, plans and prospects for Chiasma. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law. 

    Corporate Contact:

    Dawn Schottlandt

    Vice President, Investor Relations and Corporate Communications

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

    View Full Article Hide Full Article
  3. MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide

    Conference call and webcast scheduled today at 2 pm ET

    NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved MYCAPSSA®(octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA and the first product approved by the FDA utilizing Chiasma's Transient Permeability…

    MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide

    Conference call and webcast scheduled today at 2 pm ET

    NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved MYCAPSSA®(octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA and the first product approved by the FDA utilizing Chiasma's Transient Permeability Enhancer (TPE®) technology. Acromegaly is a rare chronic disease often caused by a benign pituitary tumor and characterized by excess production of growth hormone and insulin-like growth factor-1 hormone that is frequently treated with chronic burdensome injections. If left untreated, acromegaly can lead to serious, and sometimes life-threatening medical conditions. The company estimates that approximately 8,000 patients are on injectable SSAs in the U.S. 

    "The FDA approval of MYCAPSSA represents a major therapeutic advancement for people with acromegaly and validation of our TPE delivery platform," said Raj Kannan, chief executive officer of Chiasma. "We are grateful to patients, healthcare providers, advocates and clinical trial investigators, as well as our employees who have worked diligently to bring MYCAPSSA to people with acromegaly. As we move into this next exciting phase as a commercial company, we are prepared to execute on a successful U.S. launch by working with healthcare providers to bring MYCAPSSA to as many patients who could benefit from it."

    "People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options," said Jill Sisco, president of the Acromegaly Community, Inc. "The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral SSA therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers."

    "For patients living with acromegaly and for their physicians and nurses, the FDA approval of oral octreotide capsules ushers in a new era of treatment," said Shlomo Melmed, MB, ChB, MACP, executive vice president of Academic Affairs and dean of the Medical Faculty at Cedars-Sinai. "Over the last 30 years treating physicians have come to trust octreotide in the treatment of acromegaly, and an oral alternative allows patients to avoid many of the documented treatment burdens associated with injections."

    "Results from the pivotal Phase 3 CHIASMA OPTIMAL clinical trial are encouraging for patients with acromegaly," said Susan Samson, M.D., Ph.D., FRCPC, FACE, principal investigator of the CHIASMA OPTIMAL clinical trial. "Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need."

    The company expects MYCAPSSA to be commercially available in the fourth quarter of 2020 subject to FDA's timely approval of a planned manufacturing supplement to the approved NDA. Chiasma plans to scale-up its customer facing team in sales, patient services and market access to approximately 45 employees. To help patients switch to MYCAPSSA, Chiasma plans to offer an array of patient support services ranging from assistance with insurance providers and specialty pharmacies to giving patients support to help incorporate MYCAPSSA seamlessly into their daily living. The company believes that patients, physicians, nurses, and payers will appreciate the significant benefits provided by MYCAPSSA. To ensure patients have broad access to this innovation, Chiasma plans to price MYCAPSSA competitively with the fastest growing SSA in the U.S. acromegaly market reflecting the value provided by MYCAPSSA to the health care system.

    The FDA approval of MYCAPSSA was based on the positive results of the randomized, double-blind, placebo-controlled, nine-month Phase 3 CHIASMA OPTIMAL clinical trial of octreotide capsules, which met the primary endpoint and all four secondary endpoints, as well as safety data from all of Chiasma's Phase 3 clinical trials of MYCAPSSA. The following important adverse reactions are described in the MYCAPSSA prescribing information: cholelithiasis and complications of cholelithiasis; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; and decreased vitamin B12 levels and abnormal Schilling's tests.

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the FDA approval of MYCAPSSA and provide a business update today, June 26, 2020, at 2:00 pm ET. The dial-in number in the U.S. / Canada is 1-877-407-4018; for international participants, the dial-in number is 1-201-689-8471. For all callers, please refer to Conference ID 13705297. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=140270

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    CHIASMA OPTIMAL Global Phase 3 Trial

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (octreotide or lanreotide) based upon levels of IGF-1, a byproduct of increased growth hormone (GH), levels caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening). Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring reversion to prior treatment. As previously announced, CHIASMA OPTIMAL met the primary endpoint and all secondary endpoints.

    About MYCAPSSA

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. MYCAPSSA can cause a serious allergic reaction including anaphylactic shock. 

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    • Gallbladder abnormalities may occur. Monitor periodically. Discontinue if complications of cholelithiasis are suspected.
    • Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and antidiabetic treatment may need adjustment.
    • Hypothyroidism may occur. Monitor thyroid levels periodically.
    • Bradycardia, arrhythmia or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need adjustment.
    • Decreased vitamin B12 levels and abnormal Schilling's tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10 %) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, oral hypoglycemic agents, beta‑blockers, bromocriptine.

    Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA will be made available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. The company estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding the commercial plans for and the commercialization of MYCAPSSA, including its pricing, reimbursement and market adoption, statements concerning the commercial or therapeutic potential of MYCAPSSA and the anticipated market acceptance of MYCAPSSA, statements regarding the company's plan to submit manufacturing supplements and the company's expectations regarding the availability of product supply, statements concerning the timing and success of a potential commercial launch of MYCAPSSA in the United States, and statements concerning the number of customer-facing employees and the timing of their hiring. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect any manufacturing supplements to the NDA the company plans to submit to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture API and commercial octreotide capsules, the company's ability to retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 crisis may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Corporate Contact:

    Dawn Schottlandt

    Vice President, Investor Relations and Corporate Communications

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

    View Full Article Hide Full Article
  4. NEEDHAM, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today reported financial results for the first quarter of 2020 and provided a business update.

    "Chiasma continues to execute on our mission to develop and commercialize alternative options to injectable therapies," said Raj Kannan, Chief Executive Officer of Chiasma. "The COVID-19 global pandemic has changed the way we currently conduct business; however, we remain on track with our organizational readiness to execute a successful launch with MYCAPSSA in the fourth quarter…

    NEEDHAM, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today reported financial results for the first quarter of 2020 and provided a business update.

    "Chiasma continues to execute on our mission to develop and commercialize alternative options to injectable therapies," said Raj Kannan, Chief Executive Officer of Chiasma. "The COVID-19 global pandemic has changed the way we currently conduct business; however, we remain on track with our organizational readiness to execute a successful launch with MYCAPSSA in the fourth quarter of this year. If MYCAPSSA is approved, we believe that as the first oral somatostatin analog for acromegaly, it also has the potential to address a growing preference for non-medically administered products in the current environment."

    COVID-19 Business Impact – Projected 2020 Milestones Unchanged

    Chiasma is closely monitoring the impact of COVID-19 on its business and has implemented steps to ensure the well-being of its employees as well as patients and health care professionals involved in the MPOWERED study and the MACRO Registry. 

    • MYCAPSSA PDUFA Target Action Date: The U.S. Food and Drug Administration (FDA) has not notified Chiasma of any expected delays to its June 26, 2020 Prescription Drug User-Fee Act (PDUFA) target action date for our investigational oral octreotide capsules product candidate, conditionally trade-named MYCAPSSA.
       
    • MYCAPSSA Supply and Manufacturing: Chiasma has not observed any significant disruptions to the MYCAPSSA manufacturing supply chain. The company believes it will have sufficient commercial supply of MYCAPSSA to support its planned U.S. commercial launch in the fourth quarter of 2020, pending the FDA's timely approval of the NDA and a planned prior approval manufacturing supplement to the NDA.
       
    • MPOWERED Phase 3 Clinical Trial: Chiasma has been working with patients and health care professionals at MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared With injections – Evaluation of REsponse Durability) clinical trial sites to implement safety protocols for the remaining patients in the randomized controlled (RCT) phase of the trial. Of the 92 patients randomized into the nine-month RCT phase, 83 have completed the trial and six remain active in RCT. Additionally, the trial has met the European Medicines Agency (EMA) requirement of a minimum of 80 patients being randomized into the nine-month, randomized, controlled phase of the trial. The primary endpoint will be calculated with time weighted average (TWA) analysis, therefore missing monthly IGF-1 values are not anticipated to affect the completion of the primary endpoint analysis. The MPOWERED trial is designed to support an application for marketing approval of MYCAPSSA in the European Union. Chiasma remains on track to report top-line results in the fourth quarter of 2020.

    Recent Business Highlights and Anticipated 2020 Milestones

    • Anand Varadan Appointed Chief Commercial Officer (CCO): Mr.  Varadan was appointed Executive Vice President, Chief Commercial Officer in April 2020. Mr. Varadan leads Chiasma's commercial strategy and operations. He brings more than 20 years of relevant U.S. and international experience in leading both successful launches and in building commercial organizations.
       
    • Commenced Enrollment of the Management of Acromegaly (MACRO) Registry: Chiasma began enrollment, during the first quarter of 2020, in the MACRO registry which is targeting to enroll patients from over 40 clinical sites in the U.S. and collect real-world data on treatment burden and effectiveness of various acromegaly treatments.
       
    • Presentation and Publication of CHIASMA OPTIMAL Phase 3 Clinical Trial Results: Chiasma plans to present the positive results of the CHIASMA OPTIMAL trial through virtual platforms hosted by the Endocrine Society (ENDO) and American Association of Clinical Endocrinologists (AACE), in the second quarter of 2020. The company also plans to submit these positive results to a peer-reviewed journal for expected publication in mid-2020.
       
    • MYCAPSSA Planned U.S. Commercial Launch: Chiasma plans to launch MYCAPSSA in the United States in the fourth quarter of 2020, pending the FDA's timely approval of the NDA and a planned prior approval manufacturing supplement.
       
    • Top-line MPOWERED Phase 3 Clinical Trial Results: Chiasma expects to report top-line results from the MPOWERED Phase 3 open-label clinical trial of octreotide capsules in the fourth quarter of 2020.
       
    • HealthCare Royalty Partners (HCR) $75 Million Revenue Interest Financing Agreement: Chiasma entered into a revenue interest financing agreement with HCR, in April 2020, for up to $75 million to strengthen our current cash position, extend our cash runway if funding conditions are met, and to support our ongoing MYCAPSSA launch efforts.

    First Quarter 2020 Financial Results and Outlook

    • G&A Expenses: General and administrative expenses were $7.6 million for the first quarter ended March 31, 2020, compared with $2.5 million for the same period of 2019. The current period results include our continuing pre-commercial activities, an increase in compensation-related expenses, and increased other administrative costs as we prepare for the potential commercialization of octreotide capsules.
       
    • R&D Expenses: Research and development expenses were $8.1 million for the first quarter ended March 31, 2020, compared with $6.5 million for the same period of 2019. The increase was primarily driven by the manufacturing of octreotide capsules to support our commercial launch, if approved, costs associated with our disease state registry, scientific literature publications and increased regulatory costs which were offset by a decrease in clinical trial costs.
       
    • Net Loss: For the quarter ended March 31, 2020, net loss was ($15.4) million, or ($0.36) per basic share, compared with a net loss of ($8.8) million, or ($0.36) per basic share, for the same period of 2019.
       
    • Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2020, were $79.3 million, compared with $92.4 million as of December 31, 2019. In April 2020, the company received the initial $25.0 million payment, less certain transaction expenses, from HCR under the previously announced revenue interest financing agreement. Under this agreement, Chiasma is entitled to an additional $25.0 million upon FDA approval of MYCAPSSA, $15.0 million upon the availability of commercial drug supply and first commercial sale of MYCAPSSA and $10 million in early 2022 subject to the achievement of a commercial milestone. 

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the first quarter results in more detail today, May 7, 2020, at 5:00 pm ET. The dial-in number in the U.S. / Canada is 1-800-949-2175; for international participants, the dial-in number is 1-856-344-9283. For all callers, please refer to Conference ID 3434236. To access the live webcast, please use the following link: https://edge.media-server.com/mmc/p/whqk8h8r

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    CHIASMA OPTIMAL Global Phase 3 Trial

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs based upon levels of IGF-1, a byproduct of increased growth hormone, or GH, levels caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening). Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment effect include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring rescue treatment. As previously announced, CHIASMA OPTIMAL met the primary endpoint and all secondary endpoints.

    MPOWERED™ Phase 3 Trial

    Chiasma is also conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the company's oral octreotide capsules for the maintenance treatment of adult patients with acromegaly. The trial, referred to as MPOWERED, is a randomized, open-label and active-controlled, 15-month trial intended to support regulatory approval in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019. In January 2020, the randomization of patients was completed. Of the 146 patients that entered the six-month run-in phase of the trial, 92 of these patients (or 63%) completed the run-in phase and were deemed to be responders to octreotide capsules per protocol (IGF-1 <1.3 x ULN and GH<2.5 ng/mL). Responders to octreotide capsules were randomized (2:3) per protocol to either go back to their original long-acting injectable somatostatin analog or remain on octreotide capsules at the dose identified during the run-in phase and then followed for an additional nine months.   The trial has met the EMA's requirement of a minimum of 80 patients being randomized into the nine-month, randomized, controlled phase of the trial. The trial is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with standard of care injectable somatostatin receptor ligands. Chiasma expects to release top-line data from the MPOWERED Phase 3 clinical trial during the fourth quarter of 2020.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory filings and reviews and potential approvals, statements concerning the nature of the FDA's review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, statements regarding the company's plan to submit prior approval manufacturing supplements following a potential NDA approval and the company's expectations regarding the availability of product supply, statements concerning the timing and success of a potential commercial launch of MYCAPSSA in the United States, and statements regarding the release of top-line results from the MPOWERED Phase 3 trial. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations.  Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the NDA and any prior approval manufacturing supplements to the NDA the company may submit to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture API and commercial octreotide capsules, the company's ability to obtain and retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 crisis may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

    Media Relations:
    Patrick Bursey
    LifeSci Communications
    646-876-4932

     
    Chiasma, Inc.
    Condensed Consolidated Statements of Operations
    (amounts in thousands except share and per share data)
    (unaudited)
           
      For the three months ended
      March 31, 2020   March 31, 2019
    Operating expenses:      
    General and administrative $ 7,582     $ 2,450  
    Research and development   8,125       6,471  
    Total operating expenses   15,707       8,921  
    Loss from operations   (15,707 )     (8,921 )
    Other income, net   (398 )     (184 )
    Loss before income taxes   (15,309 )     (8,737 )
    Provision for income taxes   77       13  
    Net loss $ (15,386 )   $ (8,750 )
           
    Earnings per share of common stock:      
    Basic $ (0.36 )   $ (0.36 )
    Diluted $ (0.36 )   $ (0.36 )
           
    Weighted-average shares outstanding:      
    Basic   42,187,694       24,466,617  
    Diluted   42,187,694       24,466,617  
           


     
    Chiasma, Inc.
    Condensed Consolidated Balance Sheets Information
    (amounts in thousands)
    (unaudited)
           
      March 31, 2020   December 31, 2019
           
    Cash and cash equivalents $ 42,555   $ 27,855
    Marketable securities   36,707     64,520
    Prepaid expenses and other current assets   4,877     3,881
    Property and equipment, net   590     334
    Other assets   1,993     2,236
    Total assets $ 86,722   $ 98,826
           
    Accounts payable $ 5,450   $ 3,253
    Accrued expenses   7,238     7,576
    Other current liabilities   716     546
    Long-term liabilities   1,575     1,682
    Total liabilities   14,979     13,057
    Total stockholders' equity   71,743     85,769
    Total liabilities and stockholders' equity $ 86,722   $ 98,826
           

     

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  5. NEEDHAM, Mass., April 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it will host a conference call and live audio webcast on Thursday, May 7, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter ended March 31, 2020 and to provide a business update.

    Conference Call Details

    Thursday, May 7th @ 5pm Eastern Time

    Domestic:800-949-2175
    International: 856-344-9283
    Conference ID: 3434236
    Webcast:https://edge.media-server.com/mmc/p/whqk8h8r
      

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of…

    NEEDHAM, Mass., April 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it will host a conference call and live audio webcast on Thursday, May 7, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter ended March 31, 2020 and to provide a business update.

    Conference Call Details

    Thursday, May 7th @ 5pm Eastern Time

    Domestic:800-949-2175
    International: 856-344-9283
    Conference ID: 3434236
    Webcast:https://edge.media-server.com/mmc/p/whqk8h8r
      

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    About Chiasma

    Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Dawn Schottlandt

    Chiasma

    617-928-5208

     

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

     

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