On November 10, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported third quarter 2021 financial results and recent portfolio updates (Press release, SQZ Biotech, NOV 10, 2021, View Source [SID1234595296]).

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"This was another period of strong execution where we have continued to meaningfully advance our cell therapy platforms and clinical programs. We were pleased with the recent DSMB recommendation to advance our highest APC dose into combination with checkpoint inhibitors for patients with HPV16 positive cancers," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "We were also excited to announce that celiac disease will be the first autoimmune disease target for our TAC platform, with an IND submission projected for next year. These activities highlight our deep commitment to driving patient impact across disease areas through the implementation of innovative cell therapies."

Third Quarter 2021 and Recent Business and Portfolio Updates

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

Independent Data and Safety Monitoring Board (DSMB) recommends that the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 advance into the combination stage with checkpoint inhibitors
DSMB recommendation and initiation of the combination cohorts trigger Roche collaboration agreement milestone payment
Oral presentation on highest-dose cohort of SQZ-PBMC-HPV-101 trial announced for the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress, December 9, 2021 in Geneva, Switzerland
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

New eAPC preclinical data to be presented on November 12, 2021 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Congress demonstrates delivery of multiple mRNA to engineer APC function
Anticipate IND submission for the first clinical candidate by year-end 2021
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

New AAC preclinical data to be presented at SITC (Free SITC Whitepaper) highlights the potential combination therapy impact of SQZ AACs with a chemotherapy agent often used in early-line treatment of HPV16+ cancers
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Announced Q3 2022 IND submission target for celiac disease as the first clinical translation of the company’s TAC platform in autoimmune diseases
SQZ Potential Pipeline Expansion Research

Presenting first enhanced tumor infiltrating lymphocyte (TIL) preclinical data at SITC (Free SITC Whitepaper) showing the development of mRNA modified TILs with enhanced functionality in the absence of exogenous IL-2 cytokine support
Third Quarter 2021 Financial Highlights

Revenue for the third quarter 2021 was $4.8 million, compared to $6.1 million for the same period last year
Net loss for the third quarter 2021 was $22.5 million, compared to $12.4 million for the same period last year
Research and development expenses for the third quarter 2021 were $20.5 million, compared to $13.9 million for the same period last year. The increase was primarily attributable to planned development and manufacturing costs related to the eAPC platform
General and administrative expenses for the third quarter 2021 were $6.7 million, compared to $4.6 million for the same period last year. 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
As of September 30, 2021, the company had cash and cash equivalents of $164.3 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023. This projected cash runway is inclusive of the anticipated Roche milestone payment associated with the advancement of the SQZ-PBMC-HPV-101 Phase 1/2 study