SBTX Silverback Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
SBT6050
HER2 Positive Solid Tumors
|
Phase 1
Phase 1
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
SBT6290
Hepatitis B
|
Phase 1
Phase 1
|
Phase 1/1b trial to be initiated in 1Q 2022.
|
Latest News
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SBT6290 Shown to Activate Myeloid Cells and Drive Anti-tumor Effects in Nectin4-expressing Solid Tumors
Silverback Therapeutics, Inc. (NASDAQ:SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue-targeted therapeutics for the treatment of cancer, chronic viral infections and other serious diseases, will present preclinical data on its second product candidate, SBT6290, at the American Association of Cancer Research (AACR) 2021 Annual Conference, taking place virtually April 10-15. The data highlight the ability of SBT6290, a systemically administered Nectin4-directed TLR8 ImmunoTAC product candidate, to selectively activate myeloid cells in the tumor microenvironment, a promising approach to overcome resistance mechanisms associated with most current immunotherapies.
"SBT6290 showcases the versatility of our ImmunoTAC platform and along with our lead program SBT6050, exemplifies our goal to target difficult-to-treat solid tumors subset by subset. We are building on learnings from SBT6050, leveraging the same TLR8 linker-payload, which is highly transferrable across different targeting antibodies," said Valerie Odegard, Ph.D., president & chief scientific officer of Silverback Therapeutics. "These preclinical data show that SBT6290 activates human myeloid cells in a Nectin4-dependent manner and that a SBT6290 mouse surrogate confers single agent anti-tumor activity in preclinical studies. We will continue to evaluate SBT6290 in GLP toxicology studies and anticipate submitting an IND for this program in the fourth quarter of 2021."
SBT6290 comprises a selective TLR8 agonist conjugated to a Nectin4-specific monoclonal antibody. Nectin4 is a cell surface adhesion molecule that is overexpressed in multiple solid tumor types including urothelial, triple negative breast, squamous cell head and neck, and non-small cell lung cancers, with limited expression in normal tissues.
The abstract is now available on the AACR Annual Meeting website. Details of the poster presentation are as follows:
Title: SBT6290, a Systemically Administered Nectin4-Directed TLR8 ImmunoTAC® Product Candidate, is Designed for Tumor-localized Activation of Myeloid Cells
Abstract Number: 1858
Session Category: Immunology
Session Title: Therapeutic Antibodies, Including Engineered Antibodies
Virtual Poster Session Date and Time: The poster will be made available on the AACR website and Silverback website on April 10, 2021 at 8:30 a.m. ET
About Silverback Therapeutics
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback's platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com or follow us on LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback's ability to bring new treatments to patients in need, and the progress and expected timing of Silverback's drug development programs and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Initiated SBT6050 clinical development, with pharmacological activity demonstrated in the first dose cohort
Advanced preclinical development of SBT6290 and declared SBT8230 as the development candidate for chronic hepatitis B virus program
Raised $441.2 million including $277.7 million in gross proceeds from our IPO
$386.6 million in cash and cash equivalents at end of 2020
Silverback Therapeutics, Inc. (NASDAQ:SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today reported financial results and provided a corporate update for the fourth quarter and full year ended December 31, 2020.
"2020 was an extraordinary year for Silverback, with the initiation of our first clinical study for SBT6050, in which pharmacological activity was observed in the first dose cohort, the advancement of each of our preclinical programs, expansion of our strong team, and the successful closing of our IPO in December," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are well-positioned to execute on our mission to develop a new class of tissue-localized therapies that are designed to modulate fundamental biological pathways in cancer and beyond."
2020 Corporate Highlights and 2021 Anticipated Milestones
- SBT6050 (HER2-TLR8 ImmunoTAC) Phase 1/1b clinical study initiated, with pharmacological activity demonstrated in the first dose cohort. SBT6050 is being studied as a monotherapy and in combination with pembrolizumab, in patients with advanced or metastatic HER2-expressing solid tumors. Changes in pharmacodynamic markers consistent with the potential mechanism of action have been observed in patients treated in the first monotherapy dose cohort. Enrollment is ongoing in Part 1 of the study (SBT6050 monotherapy dose escalation) and treatment has been initiated in Part 3 of the study (SBT6050 plus pembrolizumab dose-escalation). Silverback is on track to deliver interim clinical data from Part 1 of the study in the second half of 2021.
- SBT6290 (Nectin4-TLR8 ImmunoTAC) continues to advance through preclinical development. SBT6290 includes the same TLR8 agonist linker-payload used in SBT6050, conjugated to a proprietary Nectin4-directed monoclonal antibody. Pre-Investigational New Drug (IND) alignment with the FDA was achieved in February 2021 and an IND application is expected in the fourth quarter of 2021. The initiation of a Phase 1/1b clinical study is anticipated in the first quarter of 2022.
- SBT8230 (ASGR1-TLR8 ImmunoTAC) development candidate selected in the fourth quarter of 2020. SBT8230 includes the same TLR8 agonist linker-payload used in SBT6050, conjugated to a proprietary ASGR1-directed monoclonal antibody, and is designed to activate human myeloid cells in the liver for treatment of chronic hepatitis B viral infection. CMC scale up and preclinical work continues with IND-enabling toxicology studies expected to commence in the first quarter of 2022.
- Completed initial public offering resulting in $277.7 million in gross proceeds. Silverback completed an IPO in December 2020, selling 13,225,000 shares at a public offering price of $21.00 per share, raising gross proceeds of $277.7 million (before deducting underwriting discounts and commissions and offering costs). In September 2020, the Company completed a Series C financing, raising $85.0 million in gross proceeds, and in March, July and September 2020, completed a Series B financing, raising $78.5 million in gross proceeds (including $10.1 million upon the conversion of then outstanding convertible notes and accrued interest thereon).
Financial Results
For the fourth quarter ended December 31, 2020, Silverback reported a net loss of $13.1 million, compared to a net loss of $7.0 million for the comparable period in 2019. For the year ended December 31, 2020, the Company reported a net loss of $32.9 million, compared to a net loss of $24.0 million for 2019. Net loss for the fourth quarter and full year of 2020 included non-cash stock-based compensation expense of $2.3 million and $2.6 million, respectively, compared to $42,000 and $148,000 for the same periods in 2019, respectively.
Research and development expenses for the fourth quarter ended December 31, 2020 were $8.8 million, compared to $6.3 million for the same period in 2019. For the year ended December 31, 2020, research and development expenses were $24.6 million, compared to $21.5 million for 2019. The increases in the Company's research and development expenses for the 2020 periods, as compared to the same periods in 2019, were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, into preclinical development. Silverback also incurred additional personnel-related expenses in 2020 as compared to 2019 as operations grew in support of program advances. These increases were partially offset by a decrease in expenses related to the development of SBT6050 as the program completed manufacturing activities and initiated a Phase 1/1b clinical trial in the second half of 2020.
General and administrative expenses for the fourth quarter ended December 31, 2020 were $4.3 million, compared to $0.7 million for the same period in 2019. For the year ended December 31, 2020, general and administrative expenses were $8.3 million, compared to $2.6 million for the same period in 2019. The increases in general and administrative expenses for the 2020 periods, as compared to the same periods in 2019, were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2020, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increase in general and administrative expenses was also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we prepared to become a public company.
As of December 31, 2020, Silverback reported cash and cash equivalents of $386.6 million, compared to $10.0 million at December 31, 2019, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months. The Company's cash and cash equivalents balance at December 31, 2020 included $255.3 million of proceeds, net of offering costs, from the Company's initial public offering in December 2020, and $153.3 million of proceeds, net of offering costs, from the Company's Series B and Series C financings in 2020. As of December 31, 2020, the Company had 34,801,537 common shares outstanding.
About Silverback Therapeutics
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback's platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback's plans and ability to bring new treatments to patients in need, the progress and expected timing of Silverback's drug development programs and clinical trials, the strength of Silverback's balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Silverback Therapeutics, Inc.
Balance Sheets
(in thousands, except share and per share data)
(unaudited)
December 31,
December 31,
2020
2019
Assets
Current assets:
Cash and cash equivalents
$
386,569
$
9,976
Prepaid expenses and other current assets
4,087
552
Total current assets
390,656
10,528
Property and equipment, net
1,618
1,316
Restricted cash
350
550
Right-of-use asset
2,180
3,253
Total assets
$
394,804
$
15,647
Liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit)
Current liabilities:
Accounts payable
$
2,583
$
3,518
Accrued expenses
5,278
2,112
Term loan payable, net
844
1,522
Convertible notes, net
—
9,991
Current portion of lease liability
896
783
Total current liabilities
9,601
17,926
Lease liability, net of current portion
2,326
3,324
Total liabilities
11,927
21,250
Commitments and contingencies
Redeemable convertible preferred stock, $0.0001 par value per share; no shares and 17,142,854 shares authorized, no shares and 15,714,283 shares issued and outstanding with aggregate liquidation preference of $0 and $55,000 at December 31, 2020 and 2019, respectively
—
53,174
Stockholders' equity (deficit):
Preferred Stock, $0.0001 par value per share; 10,000,000 and no shares authorized at December 31, 2020 and 2019, respectively; no shares issued and outstanding at December 31, 2020 and 2019
—
—
Common stock, $0.0001 par value per share; 200,000,000 and 23,500,000 shares authorized, 34,801,537 and 670,477 shares issued, and 34,701,274 and 664,431 shares outstanding at December 31, 2020 and 2019, respectively
3
—
Additional paid-in capital
479,608
5,010
Accumulated deficit
(96,734
)
(63,787
)
Total stockholders' equity (deficit)
382,877
(58,777
)
Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit)
$
394,804
$
15,647
Silverback Therapeutics, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
Year Ended
December 31,
December 31,
2020
2019
2020
2019
Operating expenses:
Research and development
$
8,837
$
6,273
$
24,577
$
21,505
General and administrative
4,264
658
8,341
2,562
Total operating expenses
13,101
6,931
32,918
24,067
Loss from operations
(13,101
)
(6,931
)
(32,918
)
(24,067
)
Interest income (expense), net
16
(39
)
(29
)
100
Net loss and comprehensive loss
$
(13,085
)
$
(6,970
)
$
(32,947
)
$
(23,967
)
Net loss per share applicable to common stockholders, basic and diluted
$
(1.37
)
$
(10.51
)
$
(11.33
)
$
(36.27
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
9,563,986
663,406
2,907,542
660,893
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Silverback Therapeutics, Inc. (NASDAQ:SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today announced the appointment of Maria Koehler, M.D., Ph.D. to Silverback's Board of Directors.
"On behalf of the board of directors and senior management team at Silverback, I am pleased to welcome Maria to the board," said Peter Thompson, M.D., Co-founder and Chair of the Silverback Board of Directors. "Maria is an accomplished biopharmaceutical veteran who has led world-class clinical development teams that have delivered transformative therapies to cancer patients. Her leadership and clinical experience will be invaluable at this stage of Silverback's growth, as we advance our lead program SBT6050 through clinical development and drive additional assets into the clinic."
Dr. Koehler joins the Silverback Board of Directors with more than 20 years of experience in the biopharmaceutical industry as a leader in clinical development. Board certified in hematology/oncology, she has experience in both early drug development and bringing new drugs to global markets, having developed strategies for all stages of cancer drug development and medical affairs. Dr. Koehler currently serves as the Chief Medical Officer at Repare Therapeutics, leading clinical strategy and overseeing all operations. Prior to joining Repare, Dr. Koehler was Chief Medical Officer at Bicycle Therapeutics. Prior to Bicycle, she was Vice President of Strategy and Innovation for Pfizer Oncology, where she led the development of palbociclib (IBRANCE) and contributed to the strategic direction of the oncology portfolio. Dr. Koehler received her M.D. and Ph.D. from the Silesian Medical School in Poland and has co-authored over 150 publications, book chapters, and patents.
"Silverback's pipeline of tissue-targeted immuno-oncology agents, which harnesses both innate and adaptive immune responses, is an elegant approach to treating solid tumors," said Dr. Koehler. "It is an important time for our industry as we bring forward more drugs with curative intent, and I am thrilled to join a passionate board of directors united by this vision."
About Silverback Therapeutics
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback's platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback's ability to bring new treatments to patients in need, and the progress and expected timing of Silverback's drug development programs and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Silverback Therapeutics, Inc. (NASDAQ:SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today announced that Laura Shawver, Ph.D., Silverback's chief executive officer, will present at the following upcoming investor conferences:
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Event: Goldman Sachs West Coast Biotech Bus Tour
Location: Virtual
Date: Tuesday, February 23, 2021
Time: 2:00 PM ET / 11:00 AM PT
-
Event: SVB Leerink 10th Annual Global Healthcare Conference
Location: Virtual
Date: Wednesday, February 24, 2021
Time: 4:20 PM ET / 1:20 PM PT
-
Event: Cowen 41st Annual Healthcare Conference
Location: Virtual
Date: Wednesday, March 3, 2021
Time: 3:20 PM ET / 12:20 PM PT
-
Event: H.C. Wainwright Global Life Sciences Conference
Location: Virtual
Date: Tuesday, March 9, 2021
Time: 7:00 AM ET / 4:00 AM PT
The webcast and archived replay of the SVB Leerink, Cowen, and H.C. Wainwright presentations will be available on the Silverback website, www.silverbacktx.com, for 30 days.
About Silverback Therapeutics
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback's platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210216005502/en/
-
Event: Goldman Sachs West Coast Biotech Bus Tour
-
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Silverback Therapeutics, Inc. (NASDAQ:SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today announced the closing of its previously announced initial public offering of 13,225,000 shares of its common stock, which includes 1,725,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $21.00 per share. Including the option exercise, the aggregate gross proceeds to Silverback from the offering were approximately $277.7 million, before deducting the underwriting discounts and commissions and offering expenses. The shares began trading on the Nasdaq Global Market on December 4, 2020, under the ticker symbol "SBTX."
Goldman Sachs & Co. LLC, SVB Leerink and Stifel acted as joint book-running managers for the offering. H.C. Wainwright & Co. acted as the lead manager for the offering.
Registration statements relating to these securities have been filed with the Securities and Exchange Commission (SEC) and became effective on December 3, 2020. Copies of the registration statements can be accessed through the SEC's website at www.sec.gov. This offering was made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201208006141/en/