On March 18, 2021 SQZ Biotechnologies (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, reported full year 2020 financial results and recent business highlights (Press release, SQZ Biotech, MAR 18, 2021, View Source [SID1234576878]).

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"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 (Free AACR Whitepaper) 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