SQZ Biotechnologies Reports Second Quarter 2023 Financial Results and Recent Portfolio Updates

08/10/2023
  • Phase 1 SQZ-AAC-HPV-101 Clinical Trial Observed a Confirmed Complete Response in the First Patient and a Best Overall Response of Stable Disease in Two Additional Patients in the Lowest-Dose Cohort; Anticipate Interim Data in the Fourth Quarter of 2023
  • SQZ® eAPC Phase 1/2 Trial Monotherapy Enrollment Complete; Anticipate Interim Data for the Highest-Dose Monotherapy Cohort in the Third Quarter of 2023
  • Company Actively Exploring Strategic Partnerships

SQZ Biotechnologies Company (OTC: SQZB), focused on unlocking the full potential of cell therapies, today reported second quarter 2023 financial results and recent portfolio updates.

“We made steady progress in the enrollment of our two clinical trials and anticipate monotherapy data readouts for each program later this year,” said Howard Bernstein, M.D., Ph.D., Interim Chief Executive Officer and Member of the Board of Directors. “We recently announced our intent to explore the Company’s potential financing options and strategic alternatives. The Management Team and the Board are committed to exploring all potential paths that could advance our programs and our technology.”

Second Quarter 2023 and Recent Portfolio Updates

Clinical Programs:

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

  • A confirmed complete response (CR), by RECIST 1.1 criteria, was observed in the first patient in the lowest-dose cohort of the SQZ-AAC-HPV-101 Phase 1 clinical trial for HPV16+ solid tumors
  • Best overall response of stable disease for two additional patients in lowest-dose cohort
  • Currently enrolling patients for the highest-dose cohort
  • Interim clinical data is anticipated in the fourth quarter of 2023

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

  • Completed enrollment for highest-dose cohort of monotherapy dose escalation trial
  • On track to report interim clinical data for the middle- and highest-dose monotherapy cohorts in the third quarter of 2023

Programs for Partnership and Collaboration:

  • The Company is actively seeking potential partnerships, collaborations or strategic alternatives to advance its oncology programs and platforms
    • The Company has full clinical development and future commercialization rights for programs targeting HPV 16 positive tumors including both the eAPC and AAC clinical programs
  • The Company has also developed and is testing a Point of Care manufacturing system that could significantly reduce the time and cost of cell manufacturing

Second Quarter 2023 Financial Highlights

  • Revenue for the quarter ended June 30, 2023, was $0.2 compared to $3.0 million for the same period in 2022
  • Research and development expenses for the quarter ended June 30, 2023, were $12.7 million compared to $18.8 million for the same period in 2022
  • General and administrative expenses for the quarter ended June 30, 2023, were $4.6 million compared to $7.0 million for the same period in 2022
  • Net loss for the quarter ended June 30, 2023, was $16.8 million, compared to $22.2 million for the same period in 2022
  • As of June 30, 2023, the Company had cash and cash equivalents of $24.7 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements through the end of 2023

About SQZ Biotechnologies

SQZ Biotechnologies is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies. The Company’s proprietary Cell Squeeze® technology offers the unique ability to deliver multiple biological materials into many patient cell types to engineer what the Company believes can be a broad range of potential therapeutics. The Company’s 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 production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, the Company believes its approach could change the way people think about cell therapies. 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. Such statements are based upon current plans, estimates and expectations of management that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as “anticipate,” “expect,” “project,” “intend,” “believe,” “may,” “will,” “should,” “plan,” “could,” “may,” “continue,” “target,” “contemplate,” “estimate,” “forecast,” “guidance,” “predict,” “possible,” “potential,” “pursue,” “likely,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. All statements, other than historical facts, including statements regarding the Company’s potential partnerships and collaborations, clinical execution and timing of data releases, the potential of the Point of Care Manufacturing system to significantly reduce the time and cost of cell therapy manufacturing and the Company’s exploration of strategic alternatives are forward-looking statements. 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, including but not limited to the important factors discussed under the caption "Risk Factors" in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and its other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements represent management's estimates as of this date and the Company 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
JUNE 30,

 

 

SIX MONTHS ENDED

JUNE 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Collaboration and grant revenue:

 

$

178

 

 

$

3,215

 

 

$

178

 

 

$

6,084

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

12,729

 

 

 

18,760

 

 

 

25,705

 

 

 

35,771

 

General and administrative

 

 

4,557

 

 

 

6,958

 

 

 

9,836

 

 

 

13,870

 

Total operating expenses

 

 

17,286

 

 

 

25,718

 

 

 

35,541

 

 

 

49,641

 

Loss from operations

 

 

(17,108

)

 

 

(22,503

)

 

 

(35,363

)

 

 

(43,557

)

Other income, net

 

 

338

 

 

 

267

 

 

 

906

 

 

 

283

 

Net loss and comprehensive loss

 

 

(16,770

)

 

 

(22,236

)

 

 

(34,457

)

 

 

(43,274

)

Net loss per share, basic and diluted

 

$

(0.57

)

 

$

(0.78

)

 

$

(1.17

)

 

$

(1.53

)

Weighted-average common shares outstanding,
basic and diluted

 

 

29,491,125

 

 

 

28,367,355

 

 

 

29,491,125

 

 

 

28,256,810

 

SQZ BIOTECHNOLOGIES COMPANY

Condensed Consolidated Balance Sheets

(In thousands)

(unaudited)

 

 

 

 

 

 

JUNE 30,
2023

 

 

DECEMBER 31,

2022

Assets

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

24,710

 

 

$

63,709

Other current assets

 

 

2,975

 

 

 

4,495

Total current assets

 

 

27,685

 

 

 

68,204

Other assets

 

 

26,463

 

 

 

31,696

Total assets

 

$

54,148

 

 

$

99,900

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities

 

 

9,911

 

 

 

21,843

Long term liabilities

 

 

19,700

 

 

 

20,909

Total liabilities

 

 

29,611

 

 

 

42,752

Total stockholders’ equity

 

 

24,537

 

 

 

57,148

Total liabilities and stockholders’ equity

 

$

54,148

 

 

$

99,900

 

SQZ Biotechnologies Investor and Media Relations:
Mike Kaiser
michael.kaiser@sqzbiotech.com
857-760-0398

Source: SQZ Biotechnologies Company