SQZ Biotechnologies Reports First Quarter 2021 Financial Results and Recent Business Highlights

WATERTOWN, Mass.--(BUSINESS WIRE)-- SQZ Biotechnologies Company (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today reported financial results for the period ended March 31, 2021 and reviewed recent business highlights.

“We continue to execute across our broad and differentiated cell therapy pipeline and are excited by the potential patient impact of these programs to treat cancer, autoimmune, and infectious diseases,” said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. “We have made progress this quarter, including continued advancement of our SQZ APC Phase 1 trial for patients with advanced or metastatic HPV+ tumors; IND clearance of our SQZ AAC program using engineered red blood cells; and presentation of preclinical data from our SQZ TACs in Type 1 diabetes models. We look forward to future milestones as we continue to advance our platforms.”

First Quarter 2021 and Recent Business Highlights

SQZ™ Antigen Presenting Cell (“APC”) Platform

• Continued dosing of patients with HPV16+ advanced or metastatic tumors in the Phase 1 clinical trial of SQZ-PBMC-HPV-101
• Presenting patient safety, biomarker, and manufacturing data from SQZ-PBMC-HPV-101 monotherapy cohorts at ASCO in June 2021

Next-Gen SQZ™ Enhanced Antigen Presenting Cell (“eAPC”) Platform

• Advancing eAPC platform with data presented at the American Association for Cancer Research 2021 annual meeting
• Anticipate filing an investigational new drug application (“IND”) for eAPC in 2021

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

• Announced SQZ AAC IND in HPV+ tumors cleared by the U.S. Food and Drug Administration

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

• Presented preclinical data at Antigen-Specific Immune Tolerance Digital Summit showing how SQZ TACs were observed to drive multiple antigen specific tolerance mechanisms, including deletion, anergy, and regulatory T cell expansion

First Quarter 2021 Financial Highlights

• Completed follow-on public offering, which allowed for the acceleration of the SQZ eAPC program towards the clinic, and pre-clinical advancement of SQZ TACs
• Cash and cash equivalents as of March 31, 2021 was $204.9 million compared to $170.4 million as of December 31, 2020
• The Company believes that the cash and cash equivalents as of March 31, 2021 will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023
• Revenue was $5.5 million for the quarter ended March 31, 2021, compared to $6.4 million for the same period in 2020
• Research and development expenses were $14.7 million for the quarter ended March 31, 2021, compared to $11.9 million for the same period in 2020. The increase was primarily attributable to planned development and manufacturing costs associated with our SQZ-AAC-HPV program’s IND as well as expanded preclinical work on SQZ eAPCs, infectious diseases, and SQZ TACs
• General and administrative (“G&A”) expenses were $6.1 million for the quarter ended March 31, 2021, compared to $5.5 million for the same period in 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
• Net loss was $15.4 million for the quarter ended March 31, 2021, compared to $10.6 million for the same period in 2020

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 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 upcoming events and presentations, our product candidates, preclinical and clinical activities, development plans, clinical efficacy, regulatory submissions, therapeutic impact and cash positions. 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 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.

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.

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