SQZ SQZ Biotechnologies Company
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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SQZ-PBMC-HPV
Solid Tumors
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Phase 1
Phase 1
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Latest News
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SQZ Biotechnologies Company (NYSE:SQZ) ("SQZ"), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced the pricing of its underwritten public offering of 3,000,000 shares of common stock at a public offering price of $20.00 per share. All of the shares of common stock are being offered by SQZ. In addition, SQZ has granted the underwriters a 30-day option to purchase up to an additional 450,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on February 17, 2021, subject to customary closing conditions.
BofA Securities, Evercore ISI and Stifel are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering.
A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission on February 11, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering can be obtained, when available, by contacting: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].
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 the registration or qualification under the securities laws of such state or jurisdiction.
Forward Looking Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to the closing of the offering. These forward-looking statements are based on management's current expectations. The words "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210212005098/en/
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SQZ Biotechnologies Company (NYSE:SQZ) ("SQZ"), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced that it has commenced an underwritten public offering of 3,000,000 shares of common stock. All of the shares of common stock are being offered by SQZ. In addition, SQZ expects to grant the underwriters a 30-day option to purchase up to an additional 450,000 shares of its common stock at the public offering price, less 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, or as to the actual size or terms of the offering.
BofA Securities, Evercore ISI and Stifel are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering.
A registration statement relating to the securities being sold in the offering has been filed with the Securities and Exchange Commission but has not yet become effective. This offering is being made only by means of a prospectus. Copies of the preliminary prospectus relating to this offering can be obtained by contacting: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].
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 the registration or qualification under the securities laws of such state or jurisdiction.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210209006210/en/
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SQZ AACs generated from red blood cells are designed to leverage a patient's professional antigen-presenters to drive T cells to attack tumors
SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced that the company's Investigational New Drug (IND) application for SQZTM Activating Antigen Carriers (SQZ AACs) in HPV+ tumors was cleared by the U.S. Food and Drug Administration (FDA). The clinical trial will investigate SQZ-AAC-HPV, a cell therapy candidate generated from red blood cells (RBCs) engineered with tumor-specific antigen to treat HPV+ tumors. This trial, SQZ-AAC-HPV-101, marks the first clinical program from the company's wholly-owned SQZ AAC platform.
SQZ AACs are a novel cellular immunotherapy candidate designed to transport tumor-specific antigen and TLR agonists to the patient's endogenous, professional, antigen presenting cells in vivo. These antigen presenting cells are capable of potent T cell activation that could potentially drive an anti-tumor effect. In preclinical studies, SQZ AACs in mouse models have demonstrated robust immune responses, CD8 T cell infiltration, and correlated tumor reduction.
"Advancing our SQZ AAC program into the clinic is a significant milestone for our team," said Armon Sharei, PhD, founder and chief executive officer of SQZ Biotechnologies. "This program further illustrates the broad cell engineering capabilities of our core technology and the diversity of our pipeline. SQZ AACs potentially open another dimension of biology where SQZ cell therapy candidates could drive patient impact."
The Phase 1 multi-center trial will enroll multiple cohorts to assess SQZ-AAC-HPV as both monotherapy and in combination with other immunoncology therapies. HLA-A*02+ patients with recurrent, locally advanced or metastatic HPV16+ head & neck, cervical, anal, penile, vulval and vaginal cancers are all eligible for the study.
"We are dedicated to leveraging our unique capabilities and novel cell therapy candidates to try to improve patients' lives by offering them potential outcomes that they need and deserve. SQZ AACs are our next approach for a potential differentiated cell therapy targeting solid tumors that could represent an exciting evolution in the cancer patient experience," said Oliver Rosen, MD, chief medical officer.
About SQZ-AAC-HPV
SQZ AACs are generated by squeezing red blood cells (RBCs) with an antigen and activating adjuvant. The process is tuned to make the engineered RBCs appear aged. Once administered to patients, SQZ AACs aim to be rapidly taken up by professional antigen presenting cells through a natural process to destroy aged RBCs in the body known as eryptosis. To take advantage of this process, SQZ AACs are designed to act as a "Trojan horse" to deliver significant quantities of antigen and activation factors to the professional, endogenous antigen presenting cells in the lymphoid organs and drive subsequent activation of T cells specific to HPV+-tumors. SQZ-AAC-HPV is the first product candidate from the SQZ AAC platform.
About SQZ Biotechnologies
SQZ Biotechnologies is a clinical-stage biotechnology company developing transformative cell therapies for patients with cancer, infectious diseases, and other serious conditions. Using its proprietary technology, SQZ Biotechnologies offers the unique ability to deliver multiple materials into many patient cell types to engineer what we believe can be an unprecedented range of potential therapeutics for a variety of diseases. SQZ Biotechnologies has the potential to create well-tolerated cell therapies that can provide therapeutic benefit for patients and to improve the patient experience over existing cell therapy approaches. With accelerated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our goal is to use the SQZ approach to establish a new paradigm for cell therapies. Our first therapeutic applications aim to leverage the potential to generate target-specific immune responses, both in activation for the treatment of solid tumors and immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. For more information please visit www.sqzbiotech.com.
Forward Looking Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to upcoming events and presentations, our product candidates, preclinical and clinical activities, regulatory requirements, clinical efficacy and therapeutic impact. These forward-looking statements are based on management's current expectations. The words "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
These and other important factors discussed under the caption "Risk Factors" in our Form 10Q filed with the U.S. Securities and Exchange Commission (SEC) on December 10, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update forward-looking statements in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct.
Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210201005211/en/
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SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel potential treatments for multiple therapeutic areas, announced today that the Immune Tolerance group leader, Shinu John, PhD, will present new preclinical data from the company's Tolerizing Antigen Carriers (SQZ™ TACs) platform in an invited talk at the Antigen-Specific Immune Tolerance (ASIT) Digital Summit taking place January 26, 2021 through January 28, 2021.
SQZ TACs are a red blood cell (RBC)-derived cell therapy candidate being developed as an antigen-specific immune tolerance platform. This platform is designed to leverage the inherently tolerogenic physiological process of RBC clearance to generate immune tolerance against target antigens. Given the flexibility in cargo that the Cell Squeeze® technology is designed to deliver, this approach is potentially applicable to many autoimmune diseases, such as type 1 diabetes and celiac disease, as well as other applications with unwanted immune responses, such as antibody responses against biologics or gene therapy vectors.
Talk Details
Antigen Specific Immune Tolerance Digital Summit
Cell Squeezing RBCs to Create Therapy for Inducing Antigen-Specific Tolerance
Shinu John, PhD
January 27, 2021 at 4:10pm EST
Slide deck available via SQZ Biotechnologies website publications pageThe presentation includes novel preclinical data highlighting SQZ TACs and the reduction of antigen-specific CD4 and CD8 T cell activity and increase antigen specific regulatory T cells (Tregs) seen with such candidates to date.
The data demonstrate that SQZ TACs were observed to:
- Trigger deletion, or apoptosis, of antigen-specific CD4 and CD8 T cells
- Functionally inactivate, or anergize, the remaining antigen-specific CD4 and CD8 T cells
- Induce or expand antigen-specific Tregs
- Protect mice in a model for type 1 diabetes with evidence of reduced infiltration of pathogenic T cells, increase in antigen-specific Tregs and preservation of insulin producing pancreatic islets.
Also included in the presentation are preclinical mouse data that show:
- The rapid uptake of SQZ TACs
- The engulfment of SQZ TACs in lymphoid organs where endogenous antigen presentation is most efficient
- Specificity of SQZ TAC immune-tolerance against target antigens without broad immune suppression.
"Our goal for the SQZ TAC platform is to create therapies that can selectively suppress the disease driving immune reaction, while allowing the balance of the immune system to function unencumbered," commented Howard Bernstein, MD, PhD, chief scientific officer of SQZ Biotechnologies. "Current approaches rely on broad, chronic immune-suppression which can compromise a patient and put them at long-term risk for infection and even some cancers. Our preclinical data show how SQZ TACs have specifically induced multiple cellular mechanisms of tolerance, which we believe indicate their potential to be developed into impactful therapeutics for many patients."
About SQZ TACs
SQZ TACs are a red blood cell-derived cell therapy candidate being developed as an antigen-specific immune tolerance platform. The platform is designed to leverage the natural process of RBC clearance by professional antigen presenting cells (APCs) in the lymphoid organs, where they engulf aged RBCs and present their components to helper (CD4) and killer (CD8) T cells. This physiological system is tolerogenic by default, instructing the immune system not to mount an attack on red blood cells. SQZ TACs are generated by squeezing RBCs with disease-specific antigen and are made to appear aged. SQZ TACs are designed to be rapidly engulfed in vivo by patient's professional APCs and to act as a "Trojan horse" to drive high quantities of antigen through the tolerogenic RBC clearance process, inducing tolerization of the patient's T cell and antibody responses against the specific target. Potential applications include autoimmune diseases, such as type 1 diabetes and celiac disease, and other applications with unwanted immune responses, such as antibody responses against biologics or gene therapy vectors.
About SQZ Biotechnologies
SQZ Biotechnologies is a clinical-stage biotechnology company developing transformative cell therapies for patients with cancer, infectious diseases, and other serious conditions. Using its proprietary technology, SQZ Biotechnologies offers the unique ability to deliver multiple materials into many patient cell types to engineer what we believe can be an unprecedented range of potential therapeutics for a variety of diseases. SQZ Biotechnologies has the potential to create well-tolerated cell therapies that can provide therapeutic benefit for patients and to improve the patient experience over existing cell therapy approaches. With accelerated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our goal is to use the SQZ™ approach to establish a new paradigm for cell therapies. Our first therapeutic applications aim to leverage the potential to generate target-specific immune responses, both in activation for the treatment of solid tumors and immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. For more information please visit www.sqzbiotech.com.
Forward Looking Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to upcoming events and presentations, our product candidates, preclinical activities and data, clinical efficacy and therapeutic impact. These forward-looking statements are based on management's current expectations. The words "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
These and other important factors discussed under the caption "Risk Factors" in our Form 10Q filed with the U.S. Securities and Exchange Commission (SEC) on December 10, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update forward-looking statements in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct.
Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210127005172/en/
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SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced that Armon Sharei, PhD, chief executive officer of SQZ, will be participating in a fireside chat at the Evercore ISI Virtual HealthCONx Conference on Wednesday, December 2, 2020 at 10:55 am EST.
To access the live webcast, please visit the "Events & Presentations" page within the Investors & Media section of the SQZ website. Replays of the webcast will be available on the SQZ website for 90 days following the event.
About SQZ Biotech
SQZ Biotech is a clinical-stage biotechnology company developing transformative cell therapies for patients with cancer, infectious diseases, and other serious conditions. Using its proprietary technology, SQZ has the unique ability to deliver multiple materials into many patient cell types to engineer what we believe to be an unprecedented range of potential therapeutics for a range of diseases. SQZ has the potential to create well-tolerated cell therapies that can provide therapeutic benefit for patients and potentially improve the patient experience over existing cell therapy approaches, with accelerated production timelines under 24 hours and the elimination of preconditioning and lengthy hospital stays. Our goal is to use the SQZ approach to establish a new paradigm for cell therapies. The first therapeutic applications leverage SQZ's ability to generate target-specific immune responses, both in activation for the treatment of solid tumors and immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. For more information please visit www.sqzbiotech.com.Forward Looking Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to upcoming events and presentations, our product candidates, preclinical or clinical trial timing, and preclinical or clinical data or results. These forward-looking statements are based on management's current expectations. The words "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
These and other important factors discussed under the caption "Risk Factors" in our Form S-1 filed with the U.S. Securities and Exchange Commission (SEC) on October 26, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update forward-looking statements in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct.
Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201123005410/en/