On May 10, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported first quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, MAY 10, 2022, View Source [SID1234614125]).

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"Our year is off to an exciting start with the FDA IND clearance to initiate clinical trials of our eAPCs – our multifunctional mRNA-based investigational cell therapy that targets solid tumors by engineering multiple T cell signals simultaneously," said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies. "We were also delighted by the recent FDA Fast Track Designation for our lead APC clinical candidate, which had promising clinical results in 2021, providing the potential to accelerate its registrational path. We look forward to continued progress on the evolution of our technology platform and unique therapeutic pipeline with anticipated clinical data across our APC, eAPC, and AAC trials in the second half of this year."

First Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for lead cell therapy candidate SQZ-PBMC-HPV; the designation is designed to accelerate the development and review of treatments for serious or life-threatening diseases
Published peer reviewed preclinical research supporting the development of SQZ APC cancer vaccine therapeutic programs in the Journal of Immunology
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 trial of SQZ-PBMC-HPV
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Received FDA IND clearance to initiate a Phase 1/2 clinical trial (COMMANDER-001) of the first eAPC therapeutic candidate in patients who have HPV16+ solid tumors
Initiated enrollment of monotherapy stage of the COMMANDER-001 trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Continued enrolling and opening additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published peer reviewed preclinical research in Frontiers in Immunology supporting potential SQZ TAC platform therapeutic development across a variety of complex autoimmune diseases
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s point-of-care manufacturing system intended to produce clinical batches
SQZ Potential Pipeline Expansion Research

Awarded $2 million grant from the National Institutes of Health that will support the development of cell engineering methods to reprogram immune cells directly into dopamine-producing neurons as a potential novel therapeutic approach for the treatment of Parkinson’s disease
First Quarter 2022 Financial Highlights

Revenue for the quarter ended March 31, 2022, was $2.9 million compared to $5.5 million for the same period in 2021
Research and development expenses for the quarter ended March 31, 2022, were $17.0 million compared to $14.7 million for the same period in 2021; the increase was primarily due to higher development and manufacturing costs associated with our clinical-stage product candidates, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
General and administrative expenses for the quarter ended March 31, 2022, were $6.9 million compared to $6.1 million for the same period in 2021; 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 quarter ended March 31, 2022, was $21.0 million, compared to $15.4 million for the same period in 2021
As of March 31, 2022, the Company had cash and cash equivalents of $122.9 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023