SQZ Biotechnologies Reports 2020 Financial Results and Recent Advancements

SQZ Biotechnologies SQZ, a cell therapy company developing novel treatments for multiple therapeutic areas, today reported full year 2020 financial results and recent business highlights.

"In 2020, we experienced the most important moment in SQZ's journey so far: dosing our first patient. This accomplishment was coupled with exciting progress across our pipeline and the transition to being a public company. Despite the many challenges of COVID-19, our team continued to maintain focus on our mission to create transformative cell therapies for patients, for which I am proud and thankful," commented Armon Sharei, chief executive officer. "We have many exciting milestones ahead and are committed to delivering on SQZ's potential for patients across diseases."

2020 and Recent Pipeline Developments

SQZ™ Antigen Presenting Cell ("APC") Platform

Oncology

• Announced initial safety data from the first 12 patients in SQZ-PBMC-HPV-101, the first clinical trial of the SQZ APC platform, demonstrated no dose limiting toxicities or grade 3 or higher treatment-related adverse events through year end 2020
• Presenting biomarker data from SQZ-PBMC-HPV-101 monotherapy cohorts in mid-2021

Infectious Diseases

• Generated preclinical data across multiple infectious disease antigens showing specific and robust CD8 T cell responses and selected HBV as initial disease target

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

• Advanced eAPC platform leveraging multiplexed delivery of mRNA cargos to incorporate additional functionality and potentially broaden addressable patient population
• Presenting preclinical data at AACR 2021 and anticipate filing an investigational new drug application ("IND") in 2021

SQZ™ Activating Antigen Carriers ("AAC") Platform in Oncology

• Announced SQZ AAC IND in HPV+ tumors was cleared by the FDA in January 2021 for a Phase 1 study to evaluate SQZ-AAC-HPV as a monotherapy and in combination with immune-oncology agents
• Continuing preclinical work for SQZ-AAC-KRAS for potential application across KRAS tumors

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

• Presented preclinical data at ASIT showing how SQZ TACs drive multiple antigen specific tolerance mechanisms, including deletion, anergy, and Treg expansion

Manufacturing and Patient Experience

• Produced doses for each patient in SQZ-PBMC-HPV-101 trial in under 24 hours
• Developing a point-of-care manufacturing prototype that could potentially enable further efficiencies in our process and improve patient accessibility to novel cell therapies

2020 and Recent Corporate Highlights

• Raised over $200 million in gross proceeds from equity financings, including a private round closed in the first half of 2020, an initial public offering in October 2020, and a follow-on public offering in February 2021
• The Company believes that the cash, cash equivalents and marketable securities as of December 31, 2020 along with the subsequent follow-on offering in February 2021 will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023
• Added key board members and advisors, including Sapna Srivastava, PhD, Paul Bolno, MD, and Marc Schegerin, MD to the Board of Directors and Kai Wucherpfenning, MD, PhD to our Scientific Advisory Board
• Added key members of senior management, including Micah Zajic as chief business officer and David First as chief people officer

2020 Full Year Financial Highlights

• Closed 2020 with $170.4 million in cash, cash equivalents and marketable securities compared to $98.3 million as of December 31, 2019
• Revenue was $21.0 million for the year ended December 31, 2020, compared to $20.1 million for the year ended December 31, 2019
• Research and development expenses were $51.5 million for the year ended December 31, 2020, as compared to $36.1 million for the year ended December 31, 2019. The increase was primarily attributable to higher development and manufacturing costs associated with translating our lead product candidate, SQZ-PBMC-HPV, into the clinic, as well as increased personnel-related costs to support continued progress with the company's pipeline
• General and administrative ("G&A") expenses were $20.5 million for the year ended December 31, 2020, compared to $18.3 million for the year ended December 31, 2019. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs, including costs to operate as a public company
• Net loss for the year ended December 31, 2020 was $50.6 million compared to $32.2 million for the year ended December 31, 2019

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 financial and cash position, upcoming events and presentations, our product candidates, preclinical and clinical activities, clinical efficacy and therapeutic impact. 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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