On March 16, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported full year 2021 financial results and recent portfolio updates (Press release, SQZ Biotech, MAR 16, 2022, View Source [SID1234610191]).
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"We have much to be proud of as 2021 was a year of significant milestones for SQZ—a major highlight was that our lead APC candidate demonstrated monotherapy clinical benefit in an advanced patient as well as favorable safety data and tolerability across all patients in the highest dose cohort," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "In addition, we received clearance of our enhanced APC IND, a multi-functional mRNA-engineered treatment, which is now our third cell therapy candidate to advance into the clinic. We continue to expand our technical and therapeutic capabilities across disease areas. In all, the continued evolution of our portfolio of Cell Squeeze powered cell therapy candidates give us confidence that we are on the right track to potentially drive broad patient impact through a new generation of cell therapies."
2021 Full Year and Recent Portfolio Updates
SQZ Antigen Presenting Cell ("APC") Platform in Oncology
Highest dose cohort of SQZ-PBMC-HPV-101 shown to induce radiographic, symptomatic, and immune response as a monotherapy in a post-checkpoint HPV+ solid tumor patient. The December 2021 EMSO-IO oral presentation of interim-data also showed:
Tumor conversion from desert to inflamed phenotype with 8-fold increase in CD8 T Cell tumor infiltration and 50-fold increase in tumor PD-L1 expression
Favorable safety data and that the investigational therapy was generally well tolerated with no dose-limiting toxicities observed
Independent Data and Safety Monitoring Board ("DSMB") recommended that the Phase 1/2 clinical trial of SQZ-PBMC-HPV-101 advance into the combination stage with immune checkpoint inhibitors
The combination stage of SQZ-PBMC-HPV-101 trial is enrolling, and the highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
Comprehensive preclinical research on SQZ APC’s ability to overcome fundamental biological barrier to effective and efficient killer T Cell activation published by the Journal of Immunology
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology
FDA IND clearance of the first eAPC clinical candidate, engineered with E6, E7, CD86, membrane bound IL-2 & IL-12, was received January 2022
New eAPC preclinical data demonstrating efficient delivery of multiple mRNA to engineer APC function was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Congress in November 2021
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology
New AAC preclinical data presented at SITC (Free SITC Whitepaper) demonstrated a synergistic benefit with SQZ AACs used in combination with cisplatin, an early-line chemotherapy agent for the treatment of multiple cancers
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance
New TAC preclinical data presented at the 2021 Federation of Clinical Immunology Societies meeting showed the ability to induce antigen-specific immune tolerance, including Treg induction, demonstrating potential for broad applicability across autoimmune diseases
TAC celiac disease program IND-enabling studies underway to support IND FDA submission planned for the first half of 2023 with our point-of-care system targeted to manufacture clinical batches
2021 Full Year and Recent Corporate Highlights
Raised $60 million in gross proceeds from a follow-on public equity offering in February 2021
Added key board members and advisors, including Bernard Coulie, M.D., Ph.D. and Patrick Vink, M.D. to the Board of Directors, and John Maraganore, Ph.D. as a strategic advisor
Accepted for membership in the Roche China Accelerator to support certain early activities in China
2021 Full Year Financial Highlights
Revenue for the year ended December 31, 2021, was $27.1 million compared to $21.0 million for the year ended December 31, 2020
Research and development expenses for the year ended December 31, 2021, were $70.1 million compared to $51.5 million for the year ended December 31, 2020; the increase was primarily due to higher development and manufacturing costs associated with translating our product candidates into the clinic, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
General and administrative expenses for the year ended December 31, 2021, were $25.7 million compared to $20.5 million for the year ended December 31, 2020; 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 year ended December 31, 2021, was $68.7 million, compared to $50.5 million for the year ended December 31, 2020
As of December 31, 2021, the Company had cash and cash equivalents of $143.5 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023