SQZ Biotechnologies Reports 2020 Financial Results and Recent Advancements
18 3월 2021 - 7:45PM
Business Wire
SQZ Biotechnologies (NYSE: SQZ), a cell therapy company
developing novel treatments for multiple therapeutic areas, today
reported full year 2020 financial results and recent business
highlights.
“In 2020, we experienced the most important moment in SQZ’s
journey so far: dosing our first patient. This accomplishment was
coupled with exciting progress across our pipeline and the
transition to being a public company. Despite the many challenges
of COVID-19, our team continued to maintain focus on our mission to
create transformative cell therapies for patients, for which I am
proud and thankful,” commented Armon Sharei, chief executive
officer. “We have many exciting milestones ahead and are committed
to delivering on SQZ’s potential for patients across diseases.”
2020 and Recent Pipeline Developments
SQZ™ Antigen Presenting Cell (“APC”)
Platform
Oncology
- Announced initial safety data from the first 12 patients in
SQZ-PBMC-HPV-101, the first clinical trial of the SQZ APC platform,
demonstrated no dose limiting toxicities or grade 3 or higher
treatment-related adverse events through year end 2020
- Presenting biomarker data from SQZ-PBMC-HPV-101 monotherapy
cohorts in mid-2021
Infectious Diseases
- Generated preclinical data across multiple infectious disease
antigens showing specific and robust CD8 T cell responses and
selected HBV as initial disease target
Next-Gen SQZ™ Enhanced Antigen Presenting
Cell (“eAPC”) Platform
- Advanced eAPC platform leveraging multiplexed delivery of mRNA
cargos to incorporate additional functionality and potentially
broaden addressable patient population
- Presenting preclinical data at AACR 2021 and anticipate filing
an investigational new drug application (“IND”) in 2021
SQZ™ Activating Antigen Carriers (“AAC”)
Platform in Oncology
- Announced SQZ AAC IND in HPV+ tumors was cleared by the FDA in
January 2021 for a Phase 1 study to evaluate SQZ-AAC-HPV as a
monotherapy and in combination with immune-oncology agents
- Continuing preclinical work for SQZ-AAC-KRAS for potential
application across KRAS tumors
SQZ™ Tolerizing Antigen Carriers (“TAC”)
Platform in Immune Tolerance
- Presented preclinical data at ASIT showing how SQZ TACs drive
multiple antigen specific tolerance mechanisms, including deletion,
anergy, and Treg expansion
Manufacturing and Patient
Experience
- Produced doses for each patient in SQZ-PBMC-HPV-101 trial in
under 24 hours
- Developing a point-of-care manufacturing prototype that could
potentially enable further efficiencies in our process and improve
patient accessibility to novel cell therapies
2020 and Recent Corporate Highlights
- Raised over $200 million in gross proceeds from equity
financings, including a private round closed in the first half of
2020, an initial public offering in October 2020, and a follow-on
public offering in February 2021
- The Company believes that the cash, cash equivalents and
marketable securities as of December 31, 2020 along with the
subsequent follow-on offering in February 2021 will be sufficient
to fund operating expenses and capital expenditure requirements
through the first half of 2023
- Added key board members and advisors, including Sapna
Srivastava, PhD, Paul Bolno, MD, and Marc Schegerin, MD to the
Board of Directors and Kai Wucherpfenning, MD, PhD to our
Scientific Advisory Board
- Added key members of senior management, including Micah Zajic
as chief business officer and David First as chief people
officer
2020 Full Year Financial Highlights
- Closed 2020 with $170.4 million in cash, cash equivalents and
marketable securities compared to $98.3 million as of December 31,
2019
- Revenue was $21.0 million for the year ended December 31, 2020,
compared to $20.1 million for the year ended December 31, 2019
- Research and development expenses were $51.5 million for the
year ended December 31, 2020, as compared to $36.1 million for the
year ended December 31, 2019. The increase was primarily
attributable to higher development and manufacturing costs
associated with translating our lead product candidate,
SQZ-PBMC-HPV, into the clinic, as well as increased
personnel-related costs to support continued progress with the
company’s pipeline
- General and administrative (“G&A”) expenses were $20.5
million for the year ended December 31, 2020, compared to $18.3
million for the year ended December 31, 2019. The increase in
G&A expenses was primarily due to an increase in personnel and
other corporate-related costs, including costs to operate as a
public company
- Net loss for the year ended December 31, 2020 was $50.6 million
compared to $32.2 million for the year ended December 31, 2019
About SQZ Biotechnologies
SQZ Biotechnologies is a clinical-stage biotechnology company
developing transformative cell therapies for patients with cancer,
infectious diseases, and other serious conditions. Using its
proprietary technology, SQZ Biotechnologies offers the unique
ability to deliver multiple materials into many patient cell types
to engineer what we believe can be an unprecedented range of
potential therapeutics for a variety of diseases. SQZ
Biotechnologies has the potential to create well-tolerated cell
therapies that can provide therapeutic benefit for patients and to
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 goal is to use the SQZ approach to establish a
new paradigm for cell therapies. Our first therapeutic applications
aim to leverage the potential to generate target-specific immune
responses, both in activation for the treatment of solid tumors and
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 financial and
cash position, upcoming events and presentations, our product
candidates, preclinical and clinical activities, clinical efficacy
and therapeutic impact. 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 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 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.
Certain information contained in this press release relates to
or is based on studies, publications, surveys and other data
obtained from third-party sources and our own internal estimates
and research. While we believe these third-party sources to be
reliable as of the date of this press release, we have not
independently verified, and we make no representation as to the
adequacy, fairness, accuracy or completeness of any information
obtained from third-party sources.
SQZ BIOTECHNOLOGIES
COMPANY
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except share and
per share amounts)
(unaudited)
YEAR ENDED DECEMBER
31,
2020
2019
Revenue
20,998
20,109
Operating expenses:
Research and development
51,545
36,102
General and administrative
20,511
18,272
Total operating expenses
72,056
54,374
Loss from operations
(51,058
)
(34,265
)
Other income (expense), net
537
2,063
Net loss
(50,521
)
(32,202
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(9.35
)
$
(18.89
)
Weighted-average common shares
outstanding, basic and diluted
5,401,895
1,704,509
SQZ BIOTECHNOLOGIES
COMPANY
Condensed Consolidated Balance
Sheets
(In thousands)
(unaudited)
DECEMBER 31,
2020
2019
Assets
Cash, cash equivalents and marketable
securities
$
170,357
$
98,282
Other current assets
6,474
3,536
Total current assets
176,831
101,818
Other assets
54,310
50,532
Total assets
$
231,141
$
152,350
Liabilities, Convertible Preferred
Stock and Stockholders’ Equity (Deficit)
Current liabilities
45,193
38,283
Long term liabilities
58,749
55,473
Total liabilities
103,942
93,756
Convertible preferred stock
—
132,109
Total stockholders’ equity (deficit)
127,199
(73,515
)
Total liabilities, convertible preferred
stock and stockholders’ equity (deficit)
$
231,141
$
152,350
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210318005189/en/
SQZ Biotechnologies IR Contact: Rebecca Cohen Corporate
and Investor Relations rebecca.cohen@sqzbiotech.com 617-758-8672
ext. 728 Media Contact: Kate Contreras
kcontreras@w2ogroup.com 617-229-5960
SQZ Biotechnologies (NYSE:SQZ)
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