SQZ Biotechnologies Reports Full Year 2021 Financial Results and Recent Portfolio Updates
SQZ Biotechnologies (NYSE: SQZ) reported its full year 2021 financial results, highlighting significant advancements in its clinical programs. The company achieved a revenue increase to $27.1 million from $21.0 million in 2020. Notable clinical milestones included the advancement of its SQZ-PBMC-HPV-101 candidate into combination therapy following positive early trial results and FDA clearance for its Enhanced APC candidate. However, the net loss widened to $68.7 million compared to $50.5 million in the previous year. Cash reserves are reported at $143.5 million.
- Revenue increased to $27.1 million, up from $21.0 million in 2020.
- Successful advancement of SQZ-PBMC-HPV-101 into combination therapy stage.
- FDA clearance obtained for Enhanced APC candidate.
- Net loss increased to $68.7 million from $50.5 million in 2020.
- Research and development expenses rose to $70.1 million, up from $51.5 million.
-
SQZ-PBMC-HPV-101 Induced Radiographic, Symptomatic and Immune Response as Monotherapy in Post-Checkpoint HPV+ Solid Tumor Patient as Demonstrated in
December 2021 ESMO-IO Oral Presentation -
DSMB Recommended SQZ-PBMC-HPV-101 Advance Into Combination Stage with Checkpoint Inhibitors in
November 2021 -
IND Submission of Next Generation Enhanced APC Therapeutic Candidate for HPV+ Solid Tumors in
December 2021 and FDA Clearance inJanuary 2022 - SQZ® APC, eAPC, and AAC Clinical Data for HPV+ Solid Tumors Anticipated Second Half 2022
“We have much to be proud of as 2021 was a year of significant milestones for SQZ—a major highlight was that our lead APC candidate demonstrated monotherapy clinical benefit in an advanced patient as well as favorable safety data and tolerability across all patients in the highest dose cohort,” said
2021 Full Year and Recent Portfolio Updates
SQZ® Antigen Presenting Cell (“APC”) Platform in Oncology
-
Highest dose cohort of SQZ-PBMC-HPV-101 shown to induce radiographic, symptomatic, and immune response as a monotherapy in a post-checkpoint HPV+ solid tumor patient. The
December 2021 EMSO-IO oral presentation of interim-data also showed:- Tumor conversion from desert to inflamed phenotype with 8-fold increase in CD8 T Cell tumor infiltration and 50-fold increase in tumor PD-L1 expression
- Favorable safety data and that the investigational therapy was generally well tolerated with no dose-limiting toxicities observed
- Independent Data and Safety Monitoring Board (“DSMB”) recommended that the Phase 1/2 clinical trial of SQZ-PBMC-HPV-101 advance into the combination stage with immune checkpoint inhibitors
- The combination stage of SQZ-PBMC-HPV-101 trial is enrolling, and the highest-dose monotherapy stage of the trial continues enrollment to further evaluate the investigational candidate in single agent settings
-
Comprehensive preclinical research on SQZ® APC’s ability to overcome fundamental biological barrier to effective and efficient killer T Cell activation published by the
Journal of Immunology
SQZ® Enhanced Antigen Presenting Cell (“eAPC”) Platform in Oncology
-
FDA IND clearance of the first eAPC clinical candidate, engineered with E6, E7, CD86, membrane bound IL-2 & IL-12, was received
January 2022 -
New eAPC preclinical data demonstrating efficient delivery of multiple mRNA to engineer APC function was presented at the
Society for Immunotherapy of Cancer (SITC) Congress inNovember 2021
SQZ® Activating Antigen Carriers (“AAC”) Platform in Oncology
- New AAC preclinical data presented at SITC demonstrated a synergistic benefit with SQZ® AACs used in combination with cisplatin, an early-line chemotherapy agent for the treatment of multiple cancers
SQZ® Tolerizing Antigen Carriers (“TAC”) Platform in Immune Tolerance
-
New TAC preclinical data presented at the 2021
Federation of Clinical Immunology Societies meeting showed the ability to induce antigen-specific immune tolerance, including Treg induction, demonstrating potential for broad applicability across autoimmune diseases - TAC celiac disease program IND-enabling studies underway to support IND FDA submission planned for the first half of 2023 with our point-of-care system targeted to manufacture clinical batches
2021 Full Year and Recent Corporate Highlights
-
Raised
in gross proceeds from a follow-on public equity offering in$60 million February 2021 -
Added key board members and advisors, including
Bernard Coulie , M.D., Ph.D. andPatrick Vink , M.D. to the Board of Directors, andJohn Maraganore , Ph.D. as a strategic advisor -
Accepted for membership in the Roche China Accelerator to support certain early activities in
China
2021 Full Year Financial Highlights
-
Revenue for the year ended
December 31, 2021 , was compared to$27.1 million for the year ended$21.0 million December 31, 2020 -
Research and development expenses for the year ended
December 31, 2021 , were compared to$70.1 million for the year ended$51.5 million December 31, 2020 ; the increase was primarily due to higher development and manufacturing costs associated with translating our product candidates into the clinic, as well as increased personnel-related costs to support continued progress with the Company’s pipeline -
General and administrative expenses for the year ended
December 31, 2021 , were compared to$25.7 million for the year ended$20.5 million December 31, 2020 ; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company -
Net loss for the year ended
December 31, 2021 , was , compared to$68.7 million for the year ended$50.5 million December 31, 2020 -
As of
December 31, 2021 , the Company had cash and cash equivalents of and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023$143.5 million
About
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 our financial condition and cash position, platform development, manufacturing capabilities, product candidates, preclinical and clinical activities, outcomes and progress, development plans and execution, clinical efficacy, regulatory submissions, therapeutic impact, anticipated data readouts, and market opportunities. 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 for the year ended
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (unaudited) |
||||||||
|
YEAR ENDED
|
|||||||
|
2021 |
|
2020 |
|||||
Collaboration revenue |
$ |
27,098 |
|
$ |
20,998 |
|
||
Operating expenses: |
|
|
||||||
Research and development |
|
70,148 |
|
|
51,545 |
|
||
General and administrative |
|
25,719 |
|
|
20,511 |
|
||
Total operating expenses |
|
95,867 |
|
|
72,056 |
|
||
Loss from operations |
|
(68,769 |
) |
|
(51,058 |
) |
||
Other income, net |
|
28 |
|
|
537 |
|
||
Net loss |
|
(68,741 |
) |
|
(50,521 |
) |
||
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(2.49 |
) |
$ |
(9.35 |
) |
||
Weighted-average common shares outstanding, basic and diluted |
|
27,578,844 |
|
|
5,401,895 |
|
Condensed Consolidated Balance Sheets (In thousands) (unaudited) |
||||||||
|
YEAR ENDED
|
|||||||
|
2021 |
|
2020 |
|||||
Assets |
|
|
||||||
Cash and cash equivalents |
$ |
143,513 |
$ |
170,357 |
||||
Other current assets |
|
7,122 |
|
6,474 |
||||
Total current assets |
|
150,635 |
|
176,831 |
||||
Other assets |
|
75,517 |
|
54,310 |
||||
Total assets |
$ |
226,152 |
$ |
231,141 |
||||
Liabilities and Stockholders’ Equity |
|
|
||||||
Current liabilities |
|
33,224 |
|
45,193 |
||||
Long term liabilities |
|
68,952 |
|
58,749 |
||||
Total liabilities |
|
102,176 |
|
103,942 |
||||
Total stockholders’ equity |
|
123,976 |
|
127,199 |
||||
Total liabilities and stockholders’ equity |
$ |
226,152 |
$ |
231,141 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20220316005879/en/
SQZ Biotechnologies Investor Relations:
michael.kaiser@sqzbiotech.com
857-760-0398
SQZ Biotechnologies Media Contact:
john.lacey@sqzbiotech.com
781-392-5514
Source:
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