- 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
WATERTOWN, Mass.–(BUSINESS WIRE)–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.
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SQZ BIOTECHNOLOGIES COMPANY Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (unaudited) |
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|
|
THREE MONTHS ENDED |
|
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SIX MONTHS ENDED JUNE 30, |
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||||||||||
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|
|
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, |
|
|
29,491,125 |
|
|
|
28,367,355 |
|
|
|
29,491,125 |
|
|
|
28,256,810 |
|
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SQZ BIOTECHNOLOGIES COMPANY Condensed Consolidated Balance Sheets (In thousands) (unaudited) |
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|
|
|
|||||
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|
|
JUNE 30, |
|
|
DECEMBER 31, 2022 |
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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 |
Contacts
SQZ Biotechnologies Investor and Media Relations:
Mike Kaiser
michael.kaiser@sqzbiotech.com
857-760-0398