SQZ Biotechnologies Reports First Quarter 2023 Financial Results and Recent Portfolio Updates
May 10 2023 - 4:45PM
Business Wire
- Phase 1 SQZ-AAC-HPV-101 Clinical Trial Resumed Following the
Observation of a Confirmed Complete Response in the First Patient
in the Lowest-Dose Cohort; Anticipate Data for the Highest-Dose
Cohort in the Fourth Quarter of 2023
- SQZ® eAPC Phase 1/2 Trial Enrollment on Track; Anticipate Data
for the Highest-Dose Monotherapy Cohort in Mid-2023
SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking
the full potential of cell therapies, today reported first quarter
2023 financial results and recent portfolio updates.
“The confirmed complete response in our first patient in the AAC
trial has brought enthusiasm to our trial sites, and we are
encouraged by the positive momentum for enrollment in both the AAC
and eAPC clinical trials,” said Howard Bernstein, M.D., Ph.D.,
Interim Chief Executive Officer and Member of the Board of
Directors. “This is a crucial period for SQZ, and I am proud of our
team’s unrelenting commitment to help our patients. We are excited
to gather more data in our trials and look forward to sharing our
findings later this year.”
First Quarter 2023 and Recent Portfolio Updates
Clinical Programs:
SQZ® Enhanced Antigen Presenting Cell (“eAPC”) Platform in
Oncology
- Enrolling highest-dose cohort of monotherapy dose escalation
trial
- On track to report initial clinical data for the middle- and
highest-dose monotherapy cohorts in the middle of 2023
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
- In light of the response, the Company resumed patient
enrollment in the SQZ-AAC-HPV-101 clinical trial
- The Study Safety Committee recommended the Company move
directly to the highest-dose cohort
- Currently enrolling patients for the highest-dose cohort
- Initial clinical data from the highest-dose cohort is
anticipated in the fourth quarter of 2023
Earlier Stage Programs:
- The Company will continue to explore partnerships and
collaborations for its earlier stage assets and programs, including
SQZ® Tolerizing Antigen Carriers (“TAC”) Platform in Immune
Tolerance
First Quarter 2023 Financial Highlights
- Revenue for the quarter ended March 31, 2023, was $0.0 compared
to $2.9 million for the same period in 2022
- Research and development expenses for the quarter ended March
31, 2023, were $13.0 million compared to $17.0 million for the same
period in 2022
- General and administrative expenses for the quarter ended March
31, 2023, were $5.3 million compared to $6.9 million for the same
period in 2022
- Net loss for the quarter ended March 31, 2023, was $17.7
million, compared to $21.0 million for the same period in 2022
- As of March 31, 2023, the Company had cash and cash equivalents
of $39.9 million and anticipates this will be sufficient to fund
operating expenses and capital expenditure requirements into
2024
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. All statements contained that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements relating to the timing and
outcome of the Company’s clinical trials, clinical safety and
efficacy of its therapeutic candidates, the potential addressable
market for the Company’s therapeutic candidates and cash
availability. 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 the Company’s significant losses incurred
since inception and expectation to incur significant additional
losses for the foreseeable future; the Company’s need for
additional funding; our ability to continue as a going concern; our
ability to successfully execute and achieve the anticipated
benefits of our restructuring plan; the development of the
Company’s initial product candidates, upon which its business is
highly dependent; the impact of the COVID-19 pandemic on the
Company’s operations and clinical activities; the lengthy,
expensive, and uncertain process of clinical drug development,
including uncertain outcomes of clinical trials and potential
delays in regulatory approval; and protection of the Company’s
proprietary technology, intellectual property portfolio and the
confidentiality of its trade secrets. These and other important
factors discussed under the caption "Risk Factors" in the Company’s
Quarterly Report on Form 10-Q, the company’s 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 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 MARCH
31,
2023
2022
Collaboration revenue
$
—
$
2,869
Operating expenses:
Research and development
12,976
17,010
General and administrative
5,279
25,719
Total operating expenses
18,255
23,922
Loss from operations
(18,255
)
(21,053
)
Other income, net
568
15
Net loss
(17,687
)
(21,038
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.60
)
$
(0.75
)
Weighted-average common shares
outstanding, basic and diluted
29,491,125
28,145,036
SQZ BIOTECHNOLOGIES
COMPANY
Condensed Consolidated Balance
Sheets
(In thousands)
(unaudited)
MARCH 31,
2023
DECEMBER 31,
2022
Assets
Cash and cash equivalents
$
39,872
$
63,709
Other current assets
4,576
4,495
Total current assets
44,448
68,204
Other assets
28,709
31,696
Total assets
$
73,157
$
99,900
Liabilities and Stockholders’ Equity
Current liabilities
12,690
21,843
Long term liabilities
20,311
20,909
Total liabilities
33,001
42,752
Total stockholders’ equity
40,156
57,148
Total liabilities and stockholders’
equity
$
73,157
$
99,900
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version on businesswire.com: https://www.businesswire.com/news/home/20230510005724/en/
SQZ Biotechnologies Investor and Media Relations: Mike
Kaiser michael.kaiser@sqzbiotech.com 857-760-0398
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