SQZ Biotechnologies Reports First Quarter 2022 Financial Results and Recent Portfolio Updates

Rhea-AI Summary

SQZ Biotechnologies (SQZ) has announced its first quarter 2022 financial results, highlighting significant developments. The FDA granted Fast Track Designation for the lead APC clinical candidate SQZ-PBMC-HPV and IND clearance to initiate a Phase 1/2 trial for the eAPC candidate targeting HPV16+ solid tumors. Total revenue for the quarter was $2.9 million, a decrease from $5.5 million in Q1 2021. R&D expenses rose to $17 million, and net loss increased to $21 million from $15.4 million in 2021. As of March 31, 2022, the company had $122.9 million in cash, sufficient to fund operations through mid-2023.

Positive

• FDA Fast Track Designation for SQZ-PBMC-HPV could accelerate development.
• IND clearance for eAPC trial enables progress in solid tumor treatment.
• Strong cash position of $122.9 million to support ongoing projects.

Negative

• Revenue declined to $2.9 million from $5.5 million year-over-year.
• R&D expenses increased to $17 million, indicating rising operational costs.
• Net loss grew to $21 million compared to $15.4 million in the same period last year.

•  Granted FDA Fast Track Designation for Lead APC Clinical Candidate
• Received FDA IND Clearance to Initiate Phase 1/2 Clinical Trial of Next Generation eAPC Therapeutic Candidate for HPV16+ Solid Tumors
• Published Peer Reviewed, Comprehensive Preclinical Research Supporting SQZ^® APC and TAC Therapeutic Programs
• Anticipated SQZ^® APC, eAPC, and AAC Clinical Data for HPV16+ Solid Tumors in Second Half 2022

WATERTOWN, Mass.--(BUSINESS WIRE)-- SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today reported first quarter 2022 financial results and recent portfolio updates.

“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

About SQZ Biotechnologies
SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients around the world and has active programs in oncology, autoimmune and infectious diseases, as well as additional exploratory initiatives to support future pipeline growth. The company’s proprietary Cell Squeeze^® technology offers the unique ability to deliver multiple biological materials into many cell types to engineer what we believe can be a broad range of potential therapeutics. With demonstrated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could significantly broaden the therapeutic range and accessibility of cell therapies. The company’s first therapeutic applications seek to generate target-specific immune responses, both in activation for the treatment of solid tumors and infectious diseases, and in immune tolerance for the treatment of autoimmune diseases. For more information, please visit www.sqzbiotech.com.

Forward Looking Statements
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 our financial condition and cash position, events and presentations, regulatory submissions, platform development, product candidates, project funding, preclinical and clinical activities, progress and outcomes, development plans, manufacturing, clinical safety and efficacy results, therapeutic potential, and market opportunities. 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 strategic collaborators; 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 most recent 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 we undertake 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.

SQZ BIOTECHNOLOGIES COMPANY Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (unaudited)
		THREE MONTHS ENDED MARCH 31,
		2022				2021
Collaboration revenue		$	2,869			$	5,454
Operating expenses:
Research and development			17,010				14,740
General and administrative			6,912				6,120
Total operating expenses			23,922				20,860
Loss from operations			(21,053	)			(15,406	)
Other income, net			15				7
Net loss			(21,038	)			(15,399	)
Net loss per share, basic and diluted		$	(0.75	)		$	(0.59	)
Weighted-average common shares outstanding, basic and diluted			28,145,036				26,264,019
SQZ BIOTECHNOLOGIES COMPANY Condensed Consolidated Balance Sheets (In thousands) (unaudited)
		MARCH 31,				DECEMBER 31,
		2022				2021
Assets
Cash and cash equivalents		$	122,914			$	143,513
Other current assets			5,003				7,122
Total current assets			127,917				150,635
Other assets			72,880				75,717
Total assets		$	200,797			$	226,152
Liabilities and Stockholders’ Equity
Current liabilities			29,499				33,224
Long term liabilities			66,384				68,952
Total liabilities			95,883				102,176
Total stockholders’ equity			104,914				123,976
Total liabilities and stockholders’ equity		$	200,797			$	226,152

 

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Investor Relations

Mike Kaiser

857-760-0398

michael.kaiser@sqzbiotech.com

Media Contact

Erin Phelps

860-729-0807

erin.phelps@sqzbiotech.com

Source: SQZ Biotechnologies

FAQ

What were the financial results for SQZ Biotechnologies in Q1 2022?

SQZ reported a revenue of $2.9 million and a net loss of $21 million for the first quarter of 2022.

What FDA designations did SQZ Biotechnologies receive recently?

SQZ received FDA Fast Track Designation for SQZ-PBMC-HPV and IND clearance for its eAPC candidate.

What is the current cash position of SQZ Biotechnologies?

As of March 31, 2022, SQZ had cash and cash equivalents of $122.9 million.

How did SQZ Biotechnologies' expenses change in Q1 2022?

R&D expenses increased to $17 million, while general administrative expenses rose to $6.9 million.