SQZ SQZ Biotechnologies Company
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Solid Tumors
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Phase 1
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SQZ Biotechnologies Company (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today reported financial results for the period ended March 31, 2021 and reviewed recent business highlights.
"We continue to execute across our broad and differentiated cell therapy pipeline and are excited by the potential patient impact of these programs to treat cancer, autoimmune, and infectious diseases," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "We have made progress this quarter, including continued advancement of our SQZ APC Phase 1 trial for patients with advanced or metastatic HPV+ tumors; IND clearance of our SQZ AAC program using engineered red blood cells; and presentation of preclinical data from our SQZ TACs in Type 1 diabetes models. We look forward to future milestones as we continue to advance our platforms."
First Quarter 2021 and Recent Business Highlights
SQZ™ Antigen Presenting Cell ("APC") Platform
- Continued dosing of patients with HPV16+ advanced or metastatic tumors in the Phase 1 clinical trial of SQZ-PBMC-HPV-101
- Presenting patient safety, biomarker, and manufacturing data from SQZ-PBMC-HPV-101 monotherapy cohorts at ASCO in June 2021
Next-Gen SQZ™ Enhanced Antigen Presenting Cell ("eAPC") Platform
- Advancing eAPC platform with data presented at the American Association for Cancer Research 2021 annual meeting
- Anticipate filing an investigational new drug application ("IND") for eAPC in 2021
SQZ™ Activating Antigen Carriers ("AAC") Platform in Oncology
- Announced SQZ AAC IND in HPV+ tumors cleared by the U.S. Food and Drug Administration
SQZ™ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance
- Presented preclinical data at Antigen-Specific Immune Tolerance Digital Summit showing how SQZ TACs were observed to drive multiple antigen specific tolerance mechanisms, including deletion, anergy, and regulatory T cell expansion
First Quarter 2021 Financial Highlights
- Completed follow-on public offering, which allowed for the acceleration of the SQZ eAPC program towards the clinic, and pre-clinical advancement of SQZ TACs
- Cash and cash equivalents as of March 31, 2021 was $204.9 million compared to $170.4 million as of December 31, 2020
- The Company believes that the cash and cash equivalents as of March 31, 2021 will be sufficient to fund operating expenses and capital expenditure requirements through the first half of 2023
- Revenue was $5.5 million for the quarter ended March 31, 2021, compared to $6.4 million for the same period in 2020
- Research and development expenses were $14.7 million for the quarter ended March 31, 2021, compared to $11.9 million for the same period in 2020. The increase was primarily attributable to planned development and manufacturing costs associated with our SQZ-AAC-HPV program's IND as well as expanded preclinical work on SQZ eAPCs, infectious diseases, and SQZ TACs
- General and administrative ("G&A") expenses were $6.1 million for the quarter ended March 31, 2021, compared to $5.5 million for the same period in 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
- Net loss was $15.4 million for the quarter ended March 31, 2021, compared to $10.6 million for the same period in 2020
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 upcoming events and presentations, our product candidates, preclinical and clinical activities, development plans, clinical efficacy, regulatory submissions, therapeutic impact and cash positions. 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)
THREE MONTHS ENDED MARCH 31,
2021
2020
Collaboration revenue
5,454
6,410
Operating expenses:
Research and development
14,740
11,868
General and administrative
6,120
5,498
Total operating expenses
20,860
17,366
Loss from operations
(15,406
)
(10,956
)
Other income, net
7
373
Net loss
(15,399
)
(10,583
)
Net loss per share attributable to common stockholders, basic and diluted
$
(0.59
)
$
(6.09
)
Weighted-average common shares outstanding, basic and diluted
26,264,019
1,737,596
SQZ BIOTECHNOLOGIES COMPANY
Condensed Consolidated Balance Sheets
(In thousands)
(unaudited)
MARCH 31,
2021
DECEMBER 31,
2020
Assets
Cash and cash equivalents
$
204,929
$
170,357
Other current assets
6,185
6,474
Total current assets
211,114
176,831
Other assets
51,757
54,310
Total assets
$
262,871
$
231,141
Liabilities and Stockholders' Equity
Current liabilities
42,379
45,193
Long term liabilities
51,207
58,749
Total liabilities
93,586
103,942
Total stockholders' equity
169,285
127,199
Total liabilities and stockholders' equity
$
262,871
$
231,141
View source version on businesswire.com: https://www.businesswire.com/news/home/20210511006192/en/
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SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced that management will be participating in the BofA (Bank of America) Securities 2021 Virtual Health Care Conference taking place May 11-13, 2021. Armon Sharei, PhD, chief executive officer, will present a corporate overview on May 12 at 8:00am EDT with a virtual webcast and the company will be hosting one on one meetings.
More information about and access to the webcast for the presentation are available on the Investors & Media section of the company website. The webcast will be available for 90 days following the presentation.
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.View source version on businesswire.com: https://www.businesswire.com/news/home/20210505005005/en/
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SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, announced today that it will present new data on the company's scaled cGMP cell therapy manufacturing program at the 2021 American Society for Gene and Cell Therapy Virtual Annual Meeting (ASGCT) from May 11-14. The company will also present findings on the performance advantages of cells engineered through its proprietary Cell Squeeze® Technology.
"There is tremendous therapeutic need for faster and more efficient delivery of impactful cell therapies to patients around the world," said Armon Sharei, PhD, Chief Executive Officer at SQZ Biotechnologies. "Through our manufacturing and therapeutic development programs, we strive to transform the current cell therapy paradigm and are excited to share our progress at ASGCT."
Rapid, Scaled cGMP and Aseptic Manufacturing Program Data
Company scientists will present new data on its proprietary Cell Squeeze® manufacturing technology demonstrating its ability to rapidly and reproducibly deliver cell therapy doses at scale. The presentation will show that the company's cGMP and aseptic manufacturing program can process 10 billion cells per minute with greater than 90 percent cell viability. The company is delivering its first investigational drug (SQZ-PBMC-HPV) utilizing this core technology for its Phase 1 clinical trial in patients with Human Papillomavirus positive (HPV+) tumors.
"The company's cell therapy manufacturing program has proven in our Phase 1 trial its ability to deliver reproducible investigational drug batches rapidly and at scale," said Howard Bernstein, MD, PhD, Chief Scientific Officer at SQZ Biotechnologies. "Our advances in cell therapy manufacturing will potentially enable multiple therapeutics across oncology, infectious disease, and immune disorders to be developed and delivered to a broad patient population."
Cell Performance Advantages
Additionally, in a poster presentation, company scientists assessed the use of Cell Squeeze® technology to deliver pre-complexed CRISPR/Cas9 RNPs to achieve multiplex-edited primary human T cells. When comparing the functional effects of the Cell Squeeze® technology to the commonly used electroporation approach, the authors found significant differences in transcriptional changes between the two treatments. Cells treated with electroporation corresponded with aberrant cytokine production, potentially resulting in premature T cell exhaustion. SQZ™ treated T cells, however, did not have disrupted transcriptional profiles or cytokine production and readily expanded post treatment with robustness similar to untreated cells.
"This work highlights the advantages of using the Cell Squeeze® technology for cell engineering," said Jonathan Gilbert, PhD, Vice President of Exploratory Research at SQZ Biotechnologies. "We demonstrate preclinically a clear distinction in cell performance with the ability to achieve multiple, distinct gene edits with more viable and functional cells."
ASGCT Presentation Titles and Timing
SQZ cGMP Manufacturing Presentation
Title: Effective and Efficient Intracellular Delivery Achieved with the Cell Squeeze® Technology Enables Rapid, Scaled, and Reproducible Production of Cell Therapies
Presenter: David Chirgwin
Session Title: Advances in Ex Vivo Modified Cell Therapies
Abstract Number: 4
Date & Time: Tuesday, May 11 from 6:15 - 6:30 PM ESTSQZ Multiplexed Gene Editing Poster
Title: Advantages of the Cell Squeeze® Technology for Multiplex Gene Editing
Presenter: Jacquelyn Hanson, PhD
Session Title: Cell Therapies
Abstract Number: 769
Date & Time: Tuesday, May 11 from 8:00 - 10:00 AM ESTAbout 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 scientific events and presentations, our product candidates, preclinical and clinical activities, development plans, application across indications, clinical efficacy, manufacturing capability 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210427005249/en/
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SQZ enhanced APCs (eAPCs) demonstrated ability to meaningfully increase CD8 T cell response through incorporation of costimulatory molecules and cytokine signaling
mRNA cargo in eAPCs enabled presentation of broader antigen repertoire, potentially expanding addressable patient populations
SQZ-APC-KRAS showed preclinical proof-of-concept for potential applicability to multiple KRAS mutations, highlighting the opportunity for expansion into additional tumor types
SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today shared preclinical data from its next generation SQZ™ APCs, enhanced APCs or eAPCs, and the potentially broader applicability of the platform at the American Association for Cancer Research (AACR) 2021 Annual Meeting.
"One of the advantages of the Cell Squeeze® technology is the ability to simultaneously engineer multiple functions in cells, the underpinning of our SQZ eAPC program. With this next generation program, we are aiming to achieve the benefits of combination therapies that can drive powerful immune responses within a single multiplexed cell therapy," said Howard Bernstein, MD, PhD, chief scientific officer of SQZ. "Our vision is to incorporate additional functionality and new antigens to the foundation we are establishing with our lead SQZ APC program. The eAPC and KRAS data presented at AACR provide preclinical examples of how we could potentially extend our impact across indications and help more patients."
SQZ eAPCs build on the power of the SQZ APC platform, which is focused on producing robust and specific CD8 T cell activation through efficient MHC-I antigen presentation. By delivering multiple mRNA into cells in a single squeeze, SQZ eAPCs are designed to further enhance T cell stimulation and boost immune-signaling that would otherwise require combinations with additional immune-oncology agents. In addition, the mRNA-based cargo facilitates presentation of a broader range of tumor epitopes, which could expand the addressable HPV+ patient population. The eAPC platform offers the opportunity for application across oncology and infectious diseases.
Highlights from the SQZ eAPC preclinical data shared at AACR (Posters 1525 and 2626) include:
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Enhancement of the quality and quantity of CD8 T cell activation by SQZ eAPCs through incorporation of CD86, membrane bound IL-2 (mbIL-2), and membrane bound IL-12 (mbIL-12), leveraging multiplexed delivery of mRNAs encoding each component
- mbIL-2 and mbIL-12 mRNA delivery via Cell Squeeze® led to surface expression of the cytokines in all measured human PBMC subsets (B cells, T cells, NK cells, and monocytes) and resulted in functional IL-2 and IL-12 signaling
- CD86, mbIL-2, and mbIL-12 mRNA delivered alone or in combination increased antigen-specific CD8 T cell responses as much as ten-fold
- Multiplexing CMVpp65 and influenza M1 mRNA antigens with signal 2/3 mRNAs enhanced the potency of SQZ APCs - inducing stronger antigen-specific CD8 T cell responses for infectious disease
- Co-squeezing E6 and E7 mRNAs drove antigen-specific CD8 T cell activation regardless of HLA haplotype, which could significantly broaden the addressable HPV+ patient population and potentially eliminate the need for HLA screening
- Cell Squeeze® mRNA delivery stimulated memory CD8 T cells across various antigens and HLA haplotypes
SQZ is leveraging the cargo flexibility of its Cell Squeeze® technology to pursue additional tumor targets. SQZ APCs have demonstrated the ability to elicit specific KRAS G12D and G12V CD8+ T cell responses in both animal models and in human cells.
Highlights from the SQZ-APC-KRAS preclinical data shared at AACR (Poster 1524) include:
- SQZ APCs engineered with KRas G12D and G12V peptides, both alone and multiplexed, generated specific and robust CD8 T cell responses against the target mutations
- KRAS G12D and G12V make up over half of all KRAS mutations, with approximately 100,000 patients per year having KRAS G12D or G12V mutated cancers in the United States
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 scientific events and presentations, our product candidates, preclinical activities, development plans, application across indications, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210410005002/en/
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Enhancement of the quality and quantity of CD8 T cell activation by SQZ eAPCs through incorporation of CD86, membrane bound IL-2 (mbIL-2), and membrane bound IL-12 (mbIL-12), leveraging multiplexed delivery of mRNAs encoding each component
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SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, today announced that management will be participating in multiple investor conferences in April 2021. Armon Sharei, PhD, chief executive officer, will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference taking place April 12-15, 2021 and will participate in a cell therapy focused panel at the Canaccord Horizons in Oncology Virtual Conference on April 15, 2021. The company will also be hosting one on one meetings at both conferences.
Needham Virtual Healthcare Conference
Presentation: Tuesday, April 13, 2021, 3:45pm EDTCanaccord Horizons in Oncology Virtual Conference
Panel: Thursday, April 15, 2021, 1:00pm EDTMore information and the webcast for the presentation at Needham will be available on the Investors & Media section of the SQZ website. The webcast will be available for 90 days following the presentation.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210406005049/en/