SQZ Biotechnologies Reports Full Year 2021 Financial Results and Recent Portfolio Updates

• SQZ-PBMC-HPV-101 Induced Radiographic, Symptomatic and Immune Response as Monotherapy in Post-Checkpoint HPV+ Solid Tumor Patient as Demonstrated in December 2021 ESMO-IO Oral Presentation
• DSMB Recommended SQZ-PBMC-HPV-101 Advance Into Combination Stage with Checkpoint Inhibitors in November 2021
• IND Submission of Next Generation Enhanced APC Therapeutic Candidate for HPV+ Solid Tumors in December 2021 and FDA Clearance in January 2022
• SQZ® APC, eAPC, and AAC Clinical Data for HPV+ Solid Tumors Anticipated Second Half 2022

WATERTOWN, Mass.–(BUSINESS WIRE)–SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today reported full year 2021 financial results and recent portfolio updates.

“We have much to be proud of as 2021 was a year of significant milestones for SQZ—a major highlight was that our lead APC candidate demonstrated monotherapy clinical benefit in an advanced patient as well as favorable safety data and tolerability across all patients in the highest dose cohort,” said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. “In addition, we received clearance of our enhanced APC IND, a multi-functional mRNA-engineered treatment, which is now our third cell therapy candidate to advance into the clinic. We continue to expand our technical and therapeutic capabilities across disease areas. In all, the continued evolution of our portfolio of Cell Squeeze® powered cell therapy candidates give us confidence that we are on the right track to potentially drive broad patient impact through a new generation of cell therapies.”

2021 Full Year and Recent Portfolio Updates

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

• Highest dose cohort of SQZ-PBMC-HPV-101 shown to induce radiographic, symptomatic, and immune response as a monotherapy in a post-checkpoint HPV+ solid tumor patient. The December 2021 EMSO-IO oral presentation of interim-data also showed:
  • Tumor conversion from desert to inflamed phenotype with 8-fold increase in CD8 T Cell tumor infiltration and 50-fold increase in tumor PD-L1 expression
  • Favorable safety data and that the investigational therapy was generally well tolerated with no dose-limiting toxicities observed
• Independent Data and Safety Monitoring Board (“DSMB”) recommended that the Phase 1/2 clinical trial of SQZ-PBMC-HPV-101 advance into the combination stage with immune checkpoint inhibitors
• The combination stage of SQZ-PBMC-HPV-101 trial is enrolling, and the highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
• Comprehensive preclinical research on SQZ® APC’s ability to overcome fundamental biological barrier to effective and efficient killer T Cell activation published by the Journal of Immunology

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

• FDA IND clearance of the first eAPC clinical candidate, engineered with E6, E7, CD86, membrane bound IL-2 & IL-12, was received January 2022
• New eAPC preclinical data demonstrating efficient delivery of multiple mRNA to engineer APC function was presented at the Society for Immunotherapy of Cancer (SITC) Congress in November 2021

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

• New AAC preclinical data presented at SITC demonstrated a synergistic benefit with SQZ® AACs used in combination with cisplatin, an early-line chemotherapy agent for the treatment of multiple cancers

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

• New TAC preclinical data presented at the 2021 Federation of Clinical Immunology Societies meeting showed the ability to induce antigen-specific immune tolerance, including Treg induction, demonstrating potential for broad applicability across autoimmune diseases
• TAC celiac disease program IND-enabling studies underway to support IND FDA submission planned for the first half of 2023 with our point-of-care system targeted to manufacture clinical batches

2021 Full Year and Recent Corporate Highlights

• Raised $60 million in gross proceeds from a follow-on public equity offering in February 2021
• Added key board members and advisors, including Bernard Coulie, M.D., Ph.D. and Patrick Vink, M.D. to the Board of Directors, and John Maraganore, Ph.D. as a strategic advisor
• Accepted for membership in the Roche China Accelerator to support certain early activities in China

2021 Full Year Financial Highlights

• Revenue for the year ended December 31, 2021, was $27.1 million compared to $21.0 million for the year ended December 31, 2020
• Research and development expenses for the year ended December 31, 2021, were $70.1 million compared to $51.5 million for the year ended December 31, 2020; the increase was primarily due to higher development and manufacturing costs associated with translating our product candidates into the clinic, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
• General and administrative expenses for the year ended December 31, 2021, were $25.7 million compared to $20.5 million for the year ended December 31, 2020; 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 year ended December 31, 2021, was $68.7 million, compared to $50.5 million for the year ended December 31, 2020
• As of December 31, 2021, the Company had cash and cash equivalents of $143.5 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 Biotechnologies Company 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, platform development, manufacturing capabilities, product candidates, preclinical and clinical activities, outcomes and progress, development plans and execution, clinical efficacy, regulatory submissions, therapeutic impact, anticipated data readouts, 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 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 Annual Report on Form 10-K for the year ended December 31, 2021, 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 SQZ undertakes 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.

Contacts

SQZ Biotechnologies Investor Relations:
Mike Kaiser

[email protected]
857-760-0398

SQZ Biotechnologies Media Contact:
John Lacey

[email protected]
781-392-5514