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

• Published Comprehensive Preclinical Research on SQZ® AAC Platform in Frontiers in Immunology
• Continued Investigational New Drug-Enabling Activities for SQZ® TAC Platform; Submission Expected in First Half of 2023 with Clinical Batches Intended to be Manufactured on the Company’s Point-of-Care System
• Anticipate Interim Clinical Data for HPV16+ Solid Tumors by the End of 2022

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

“I am proud of the SQZ team's accomplishments this quarter, including our publication showcasing the AAC platform, advancing our autoimmune preclinical work, and progress made developing our integrated point-of-care manufacturing system,” said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. “As we head into the final stretches of the year, we look forward to sharing the latest available clinical data from our three oncology trials.”

Third Quarter 2022 and Recent Portfolio Updates

SQZ® Antigen Presenting Cell (“APC”) Platform in Oncology

• Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV-101) trial
• Anticipate additional monotherapy data in the highest-dose cohort and initial, interim data for patients in combination with checkpoint inhibitors

SQZ® Enhanced Antigen Presenting Cell (“eAPC”) Platform in Oncology

• Continued enrollment for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
• Anticipate initial cohort 1 data by the end of 2022

SQZ® Activating Antigen Carriers (“AAC”) Platform in Oncology

• Published comprehensive preclinical research in Frontiers in Immunology
• Continued enrollment 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

• Progressed studies supporting anticipated TAC Investigational New Drug (IND) submission for celiac disease in the first half of 2023
• Company’s Point-of-Care (POC) manufacturing system intended to produce clinical batches and be operated outside of an ISO 7 cleanroom

SQZ® Point-of-Care Manufacturing

• Continued development and testing for utilization in anticipated SQZ® TAC IND submission in the first half of 2023
• Commenced evaluation of POC to produce additional therapeutic candidates to reduce future manufacturing-related costs; assessing the possibility of allowing access to the Cell Squeeze® technology, associated methods and clinical-scale systems for manufacturing uses together with third parties

Recent Corporate Highlights

• Elevated Micah Zajic to Chief Financial Officer from Chief Business Officer
• Transitioned Chief Scientific Officer (CSO), Howard Bernstein, M.D., Ph.D., to the company’s Board of Directors; announced the division of CSO responsibilities among three experienced internal leaders: Ipsita Roymoulik, Ph.D., SVP, Chemistry Manufacturing and Controls; Scott Loughhead, Ph.D., VP, Translational Research; and Maisam Dadgar, Head of Engineering

Third Quarter 2022 Financial Highlights

• Revenue for the quarter ended September 30, 2022, was $3.5 million compared to $4.8 million for the same period in 2021
• Research and development expenses for the quarter ended September 30, 2022, were $19.6 million compared to $20.5 million for the same period in 2021; the decrease was primarily due to lower upfront manufacturing, materials and setup costs associated with the SQZ-eAPC-HPV trial
• General and administrative expenses for the quarter ended September 30, 2022, were $6.9 million compared to $6.7 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
• Net loss for the quarter ended September 30, 2022, was $22.6 million, compared to $22.5 million for the same period in 2021
• As of September 30, 2022, the Company had cash and cash equivalents of $84.2 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023

About SQZ Biotechnologies

SQZ Biotechnologies is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies to benefit patients with cancer, autoimmune and infectious diseases. The company’s proprietary Cell Squeeze® technology offers the unique ability to deliver multiple biological materials into many patient cell types to engineer what we believe can be a broad range of potential therapeutics. Our goal is to create well-tolerated cell therapies that can provide therapeutic benefit for patients and improve the patient experience over existing cell therapy approaches. With accelerated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could change the way people think about cell therapies. The company’s first therapeutic applications seek to generate target-specific immune responses, both in immune activation for the treatment of solid tumors and in immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. For more information, please visit www.sqzbiotech.com.

Forward Looking Statement

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 events and presentations, platform and clinical development, product candidates, preclinical and clinical activities, progress and outcomes, development and manufacturing plans, financial and cash position, executive management, regulatory submissions, clinical safety and efficacy results, and therapeutic potential. 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; our ability to continue as a going concern; 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 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 Quarterly Report on Form 10-Q, our 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 SQZ undertakes 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

SEPTEMBER 30,

 

NINE MONTHS ENDED

SEPTEMBER 30,

 

2022

 

2021

 

2022

 

2021

 

 

 

 

 

 

Collaboration and grant revenue

$

3,452

 

$

4,755

 

$

9,535

 

$

14,748

 

Operating expenses:

 

 

 

 

Research and development

 

19,631

 

 

20,520

 

 

55,401

 

 

52,942

 

General and administrative

 

6,919

 

 

6,691

 

 

20,789

 

 

18,744

 

Total operating expenses

 

26,550

 

 

27,211

 

 

76,190

 

 

71,686

 

Loss from operations

 

(23,098

)

 

(22,456

)

 

(66,655

)

 

(56,938

)

Other income, net

 

455

 

 

6

 

 

738

 

 

19

 

Net loss

 

(22,643

)

 

(22,450

)

 

(65,917

)

 

(56,919

)

Net loss per share, basic and diluted

$

(0.77

)

$

(0.80

)

$

(2.30

)

$

(2.08

)

Weighted-average common shares outstanding, basic and diluted

 

29,284,151

 

 

28,050,130

 

 

28,603,020

 

 

27,421,839

 

SQZ BIOTECHNOLOGIES COMPANY

Condensed Consolidated Balance Sheets

(In thousands)

(unaudited)

 

SEPTEMBER 30,

DECEMBER 31,

 

2022

2021

Assets

 

 

Cash and cash equivalents

$

84,239

$

143,513

Other current assets

 

3,098

 

7,122

Total current assets

 

87,337

 

150,635

Other assets

 

67,517

 

75,517

Total assets

$

154,854

$

226,152

Liabilities and Stockholders’ Equity

 

 

Current liabilities

$

25,261

$

33,224

Long term liabilities

 

61,019

 

68,952

Total liabilities

 

86,280

 

102,176

Total stockholders’ equity

 

68,574

 

123,976

Total liabilities and stockholders’ equity

$

154,854

$

226,152

 

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Investor Relations Mike Kaiser 857-760-0398 [e-mail]

Media Erin Phelps 860-729-0807 [e-mail]