- Granted FDA Fast Track Designation for APC Clinical Candidate
- Published Comprehensive Preclinical Research on SQZ® TAC Platform in Frontiers in Immunology
- Presented First SQZ® Point-of-Care (POC) Manufacturing System Performance Data; Initial Clinical Use Planned for SQZ® TAC Celiac Disease Program with IND Submission Expected in First Half 2023
- Strengthened Leadership with Experienced CMO and CFO Appointments
- Anticipate Clinical Data for HPV16+ Solid Tumors across programs in Second Half 2022
WATERTOWN, Mass.–(BUSINESS WIRE)–SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today reported second quarter 2022 financial results and recent portfolio updates.
“We are excited by meaningful progress in our clinical trials and also the receipt of FDA Fast Track Designation for our APC clinical candidate across HPV16+ tumors,” said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. “We also highlighted the progress in developing our Point-of-Care manufacturing system which supports our long-term vision to enable broad accessibility of cell therapies. Finally, I am delighted by the addition of our newest senior team member, Dr. Marshelle Smith Warren as our Chief Medical Officer, and the elevation of Micah Zajic to Chief Financial Officer.”
Second Quarter 2022 and Recent Portfolio Updates
SQZ® Antigen Presenting Cell (“APC”) Platform in Oncology
- Granted FDA Fast Track Designation for SQZ-PBMC-HPV, our APC clinical candidate, for HPV16+ advanced or metastatic tumors
- Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV) trial
SQZ® Enhanced Antigen Presenting Cell (“eAPC”) Platform in Oncology
- Presented SQZ® eAPC preclinical data at the American Association for Cancer Research (AACR) annual meeting demonstrating that delivery of multiple mRNAs encoding for disease-specific antigens and immune stimulators had a synergistic effect that substantially increased killer T cell activity in humanized mouse models
- Initiated enrollment and opened additional sites for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
SQZ® Activating Antigen Carriers (“AAC”) Platform in Oncology
- Published trial in progress poster at the AACR annual meeting highlighting the SQZ® AAC platforms potential to drive robust CD8 T cell activation and tumor killing
- Continued enrollment and opened additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ® Tolerizing Antigen Carriers (“TAC”) Platform in Immune Tolerance
- Published comprehensive preclinical research in Frontiers in Immunology
- Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s POC manufacturing system intended to produce clinical batches
SQZ® Point-of-Care Manufacturing
- Presented non-clinical POC manufacturing performance data at the American Society for Gene and Cell Therapy (ASGCT) annual meeting demonstrating reduced manufacturing time and comparable or improved product specifications relative to current cleanroom-based processes
Recent Corporate Highlights
- Appointed two experienced executives to leadership roles: Marshelle Smith Warren, M.D. joined as Chief Medical Officer, and Micah Zajic was elevated to Chief Financial Officer
Second Quarter 2022 Financial Highlights
- Revenue for the quarter ended June 30, 2022, was $3.2 million compared to $4.5 million for the same period in 2021
- Research and development expenses for the quarter ended June 30, 2022, were $18.8 million compared to $17.7 million for the same period in 2021; the increase was primarily due to higher personnel-related costs including stock-based compensation expense, to support continued progress with the company’s pipeline
- General and administrative expenses for the quarter ended June 30, 2022, were $7.0 million compared to $5.9 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs
- Net loss for the quarter ended June 30, 2022, was $22.2 million, compared to $19.1 million for the same period in 2021
- As of June 30, 2022, the Company had cash and cash equivalents of $105.6 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023
About SQZ Biotechnologies
SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients around the world. The company has active programs in oncology, autoimmune and infectious diseases, as well as additional exploratory initiatives to support future pipeline growth. SQZ’s proprietary Cell Squeeze® technology can deliver multiple biological materials into many cell types, offering the ability to engineer a broad range of potential therapeutics. With clinical production timelines already under 24 hours, the company has the potential to enable broader patient accessibility through point-of-care manufacturing implementation across multiple therapeutic programs. Our approach could also improve a patient’s treatment journey with no planned hospitalization or preconditioning treatment. The company’s first therapeutic efforts seek to generate target-specific immune responses, both through activation for the treatment of solid tumors and infectious diseases, and by immune tolerance for the treatment of autoimmune diseases. 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 executive management, regulatory submissions, platform and clinical development, product candidates, preclinical and clinical activities, progress and outcomes, business development and strategic collaborations, financial and cash position, clinical safety and efficacy results, and therapeutic potential. 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 strategic collaborators; 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 most recent 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 we undertake 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 |
|
|
SIX MONTHS ENDED |
|
||||||||||
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Collaboration and grant revenue |
|
$ |
3,215 |
|
|
$ |
4,539 |
|
|
$ |
6,084 |
|
|
$ |
9,993 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Research and development |
|
|
18,760 |
|
|
|
17,682 |
|
|
|
35,771 |
|
|
|
32,422 |
|
|
General and administrative |
|
|
6,958 |
|
|
|
5,933 |
|
|
|
13,870 |
|
|
|
12,054 |
|
|
Total operating expenses |
|
|
25,718 |
|
|
|
23,615 |
|
|
|
49,641 |
|
|
|
44,476 |
|
|
Loss from operations |
|
|
(22,503 |
) |
|
|
(19,076 |
) |
|
|
(43,557 |
) |
|
|
(34,483 |
) |
|
Other income, net |
|
|
267 |
|
|
|
6 |
|
|
|
283 |
|
|
|
14 |
|
|
Net loss |
|
|
(22,236 |
) |
|
|
(19,070 |
) |
|
|
(43,274 |
) |
|
|
(34,469 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.68 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.27 |
) |
|
Weighted-average common shares outstanding, basic and diluted |
|
|
28,367,355 |
|
|
|
27,919,647 |
|
|
|
28,256,810 |
|
|
|
27,100,817 |
|
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SQZ BIOTECHNOLOGIES COMPANY Condensed Consolidated Balance Sheets (In thousands) (unaudited) |
|||||||
|
|
JUNE 30, |
|
|
DECEMBER 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
|
Assets |
|
|
|
|
|
||
|
Cash and cash equivalents |
$ |
105,561 |
|
|
$ |
143,513 |
|
|
Other current assets |
|
4,491 |
|
|
|
7,122 |
|
|
Total current assets |
|
110,052 |
|
|
|
150,635 |
|
|
Other assets |
|
70,259 |
|
|
|
75,517 |
|
|
Total assets |
$ |
180,311 |
|
|
$ |
226,152 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
||
|
Current liabilities |
$ |
28,443 |
|
|
$ |
33,224 |
|
|
Long term liabilities |
|
63,680 |
|
|
|
68,952 |
|
|
Total liabilities |
|
92,123 |
|
|
|
102,176 |
|
|
Total stockholders’ equity |
|
88,188 |
|
|
|
123,976 |
|
|
Total liabilities and stockholders’ equity |
$ |
180,311 |
|
|
$ |
226,152 |
|
Contacts
Investor Relations
Mike Kaiser
857-760-0398
michael.kaiser@sqzbiotech.com
Media Contact
Erin Phelps
860-729-0807
erin.phelps@sqzbiotech.com