WATERTOWN, Mass.–(BUSINESS THREAD)–SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today reported second quarter 2022 financial results and recent portfolio updates.
“We are excited about the significant progress in our clinical trials and also the receipt of FDA Fast Track designation for our APC clinical candidate in HPV16+ tumors,” said Armon Sharei, Ph.D., CEO and Founder of SQZ Biotechnologies. “We also highlighted progress in the development of our point-of-care manufacturing system that supports our long-term vision to enable broad accessibility of cell therapies. Finally, I am delighted with the addition of our member team’s newest senior, Dr. Marshelle Smith Warren as Chief Medical Officer, and the elevation of Micah Zajic to Chief Financial Officer.”
Q2 2022 and recent portfolio updates
SQZ® Antigen Presenting Cell (“APC”) Platform in Oncology
Granted FDA Fast Track Designation for SQZ-PBMC-HPV, our APC clinical candidate, for advanced or metastatic HPV16+ tumors Continued enrollment of high-dose monotherapy and combination with checkpoint inhibitors in the phase 1/2 trial (SQZ-PBMC-HPV)
SQZ® Enhanced Antigen Presenting Cell (“eAPC”) platform in oncology
Preclinical data from SQZ® eAPCs were presented at the American Association for Cancer Research (AACR) Annual Meeting demonstrating that delivery of multiple mRNAs encoding disease-specific antigens and immune stimulators had a synergistic effect that substantially increased killer T cell activity in humanized mouse models. and opened additional sites for the monotherapy phase of the COMMANDER-001 Phase 1/2 trial (SQZ-eAPC-VPH)
SQZ® Activating Antigen Carriers (“AAC”) platform in oncology
An ongoing trial poster was published at the AACR Annual Meeting highlighting the potential of SQZ® AAC platforms to drive robust CD8 T cell activation and tumor destruction. Continued enrollment and opening of additional sites for the monotherapy phase 1/2 phase ENVOY-001 (SQZ-AAC). -HPV-101 test).
SQZ® Tolerizing Antigen Carriers (“TAC”) platform in immune tolerance
Comprehensive Preclinical Research Published in Frontiers in Immunology Advanced Studies Supporting Early Filing of TAC IND for Celiac Disease in First Semester 2023; company’s POC manufacturing system intended to produce clinical batches
Manufacturing at the SQZ® point of care
Nonclinical POC manufacturing performance data presented at the American Society for Cell and Gene Therapy (ASGCT) Annual Meeting demonstrating reduced manufacturing time and comparable or improved product specifications relative to current processes based on clean rooms.
Latest corporate aspects
Two experienced executives were named to leadership roles: Marshelle Smith Warren, MD, joined as chief medical officer and Micah Zajic was promoted to chief financial officer.
Financial data for the second quarter of 2022
Revenue for the quarter ended June 30, 2022 was $3.2 million compared to $4.5 million for the same period in 2021. Research and development expenses for the quarter ended June 30 2022 were $18.8 million compared to $17.7 million for the same period in 2021; The increase was primarily due to higher personnel-related costs, including stock-based compensation expense, to support continued progress with the Company’s pipeline. General and administrative expenses for the quarter ended June 30, 2022 were $7.0 million compared to $5.9 million for the same period. in 2021; The increase was primarily due to higher personnel and other company-related costs, including stock-based compensation expense and other costs Net loss for the quarter ended June 30, 2022 was 22.2 million of $19.1 million, compared to $19.1 million for the same period in 2021. As of June 30, 2022, the company had cash and cash equivalents of $105.6 million and anticipates that this will be sufficient to finance operating expenses and capital expenditure requirements during the fourth quarter of 2023.
About SQZ Biotechnologies
SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients worldwide. The company has active programs in oncology, autoimmune and infectious diseases, as well as additional exploratory initiatives to support future portfolio growth. SQZ’s proprietary Cell Squeeze® technology can deliver multiple biological materials to many cell types, offering the ability to engineer a wide range of potential therapeutics. With clinical production lead times already under 24 hours, the company has the potential to enable broader patient accessibility by implementing point-of-care manufacturing in various therapeutic programs. Our approach could also improve a patient’s treatment journey without any hospitalization or preconditioning. The company’s early therapeutic efforts seek to generate target-specific immune responses, both through activation for the treatment of solid tumors and infectious diseases, and immune tolerance for the treatment of autoimmune diseases. For more information, 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 herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding with executive management, regulatory submissions, platform and clinical development, product candidates, preclinical and clinical activities, progress and results, business development and strategic partnerships, financial and cash position, safety results and clinical efficacy and therapeutic potential. These forward-looking statements are based on management’s current expectations. Actual results could differ from those projected in any forward-looking statement due to various risk factors. These factors include, but are not limited to, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and the expectation of incurring additional significant losses in the foreseeable future; the development of our initial product candidates, on which our business is highly dependent; the impact of the COVID-19 pandemic on our clinical operations and activities; our need for additional financing and our cash flow; the lengthy, expensive and uncertain process of clinical drug development, including uncertain clinical trial results and potential delays in regulatory approval; our ability to maintain our relationships with our external suppliers 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 heading “Risk Factors” in our most recent Annual Report on Form 10-K and other filings with the US Securities and Exchange Commission could cause actual results to differ materially from those indicate forward-looking statements. . Any forward-looking statements represent management’s estimates as of the date hereof, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, the occurrence of current events or otherwise, unless the law requires it.
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