SQZ Biotechnologies Reports First Quarter 2022 Financial Results and Recent Portfolio Updates

•  Granted FDA Fast Track Designation for Lead APC Clinical Candidate
• Received FDA IND Clearance to Initiate Phase 1/2 Clinical Trial of Next Generation eAPC Therapeutic Candidate for HPV16+ Solid Tumors
• Published Peer Reviewed, Comprehensive Preclinical Research Supporting SQZ^® APC and TAC Therapeutic Programs
• Anticipated SQZ^® APC, eAPC, and AAC Clinical Data for HPV16+ Solid Tumors in Second Half 2022

WATERTOWN, Mass.--(BUSINESS WIRE)-- SQZ Biotechnologies (SQZ) , focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today reported first quarter 2022 financial results and recent portfolio updates.

“Our year is off to an exciting start with the FDA IND clearance to initiate clinical trials of our eAPCs – our multifunctional mRNA-based investigational cell therapy that targets solid tumors by engineering multiple T cell signals simultaneously,” said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies (SQZ). “We were also delighted by the recent FDA Fast Track Designation for our lead APC clinical candidate, which had promising clinical results in 2021, providing the potential to accelerate its registrational path. We look forward to continued progress on the evolution of our technology platform and unique therapeutic pipeline with anticipated clinical data across our APC, eAPC, and AAC trials in the second half of this year.”

First Quarter 2022 and Recent Portfolio Updates

SQZ^® Antigen Presenting Cell (“APC”) Platform in Oncology

• Granted FDA Fast Track Designation for lead cell therapy candidate SQZ-PBMC-HPV; the designation is designed to accelerate the development and review of treatments for serious or life-threatening diseases
• Published peer reviewed preclinical research supporting the development of SQZ^® APC cancer vaccine therapeutic programs in the Journal of Immunology
• Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 trial of SQZ-PBMC-HPV

SQZ^® Enhanced Antigen Presenting Cell (“eAPC”) Platform in Oncology

• Received FDA IND clearance to initiate a Phase 1/2 clinical trial (COMMANDER-001) of the first eAPC therapeutic candidate in patients who have HPV16+ solid tumors
• Initiated enrollment of monotherapy stage of the COMMANDER-001 trial

SQZ^® Activating Antigen Carriers (“AAC”) Platform in Oncology

• Continued enrolling and opening additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial

SQZ^® Tolerizing Antigen Carriers (“TAC”) Platform in Immune Tolerance

• Published peer reviewed preclinical research in Frontiers in Immunology supporting potential SQZ^® TAC platform therapeutic development across a variety of complex autoimmune diseases
• Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s point-of-care manufacturing system intended to produce clinical batches

SQZ^® Potential Pipeline Expansion Research

• Awarded $2 million grant from the National Institutes of Health that will support the development of cell engineering methods to reprogram immune cells directly into dopamine-producing neurons as a potential novel therapeutic approach for the treatment of Parkinson’s disease

First Quarter 2022 Financial Highlights

• Revenue for the quarter ended March 31, 2022, was $2.9 million compared to $5.5 million for the same period in 2021
• Research and development expenses for the quarter ended March 31, 2022, were $17.0 million compared to $14.7 million for the same period in 2021; the increase was primarily due to higher development and manufacturing costs associated with our clinical-stage product candidates, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
• General and administrative expenses for the quarter ended March 31, 2022, were $6.9 million compared to $6.1 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
• Net loss for the quarter ended March 31, 2022, was $21.0 million, compared to $15.4 million for the same period in 2021
• As of March 31, 2022, the Company had cash and cash equivalents of $122.9 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023

About SQZ Biotechnologies (SQZ)
SQZ Biotechnologies Company (SQZ) is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients around the world and has active programs in oncology, autoimmune and infectious diseases, as well as additional exploratory initiatives to support future pipeline growth. The company’s proprietary Cell Squeeze^® technology offers the unique ability to deliver multiple biological materials into many cell types to engineer what we believe can be a broad range of potential therapeutics. With demonstrated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could significantly broaden the therapeutic range and accessibility of cell therapies. The company’s first therapeutic applications seek to generate target-specific immune responses, both in activation for the treatment of solid tumors and infectious diseases, and in immune tolerance for the treatment of autoimmune diseases. For more information, please visit www.sqzbiotech.com.

Forward Looking Statements
This press release contains 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 without limitation statements relating to our financial condition and cash position, events and presentations, regulatory submissions, platform development, product candidates, project funding, preclinical and clinical activities, progress and outcomes, development plans, manufacturing, clinical safety and efficacy results, therapeutic potential, and market opportunities. These forward-looking statements are based on management's current expectations. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors and strategic collaborators; and protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets. These and other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission 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 and we undertake no duty to update these forward-looking statements, whether as a result of new information, the occurrence of current events, or otherwise, unless required by law.

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Source: SQZ Biotechnologies (SQZ)