Silverback Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Updates
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
“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
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.
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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 inDecember 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). InSeptember 2020 , the Company completed a Series C financing, raising$85.0 million in gross proceeds, and in March, July andSeptember 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
Research and development expenses for the fourth quarter ended
General and administrative expenses for the fourth quarter ended
As of
About
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
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Balance Sheets |
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(in thousands, except share and per share data) |
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(unaudited) |
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2020 |
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2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
386,569 |
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$ |
9,976 |
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Prepaid expenses and other current assets |
4,087 |
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552 |
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Total current assets |
390,656 |
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10,528 |
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Property and equipment, net |
1,618 |
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1,316 |
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Restricted cash |
350 |
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550 |
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Right-of-use asset |
2,180 |
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3,253 |
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Total assets |
$ |
394,804 |
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$ |
15,647 |
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Liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) |
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Current liabilities: |
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Accounts payable |
$ |
2,583 |
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$ |
3,518 |
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Accrued expenses |
5,278 |
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2,112 |
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Term loan payable, net |
844 |
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1,522 |
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Convertible notes, net |
— |
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9,991 |
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Current portion of lease liability |
896 |
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783 |
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Total current liabilities |
9,601 |
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17,926 |
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Lease liability, net of current portion |
2,326 |
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3,324 |
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Total liabilities |
11,927 |
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21,250 |
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Commitments and contingencies |
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Redeemable convertible preferred stock, |
— |
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53,174 |
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Stockholders' equity (deficit): |
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Preferred Stock, |
— |
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— |
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Common stock, |
3 |
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— |
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Additional paid-in capital |
479,608 |
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5,010 |
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Accumulated deficit |
(96,734 |
) |
(63,787 |
) |
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Total stockholders' equity (deficit) |
382,877 |
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(58,777 |
) |
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Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) |
$ |
394,804 |
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$ |
15,647 |
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Statements of Operations and Comprehensive Loss |
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(in thousands, except share and per share data) |
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(unaudited) |
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Three Months Ended |
Year Ended |
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2020 |
2019 |
2020 |
2019 |
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Operating expenses: |
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Research and development |
$ |
8,837 |
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$ |
6,273 |
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$ |
24,577 |
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$ |
21,505 |
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General and administrative |
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4,264 |
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658 |
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8,341 |
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2,562 |
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Total operating expenses |
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13,101 |
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6,931 |
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32,918 |
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24,067 |
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Loss from operations |
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(13,101 |
) |
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(6,931 |
) |
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(32,918 |
) |
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(24,067 |
) |
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Interest income (expense), net |
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16 |
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(39 |
) |
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(29 |
) |
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100 |
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Net loss and comprehensive loss |
$ |
(13,085 |
) |
$ |
(6,970 |
) |
$ |
(32,947 |
) |
$ |
(23,967 |
) |
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Net loss per share applicable to common stockholders, basic and diluted |
$ |
(1.37 |
) |
$ |
(10.51 |
) |
$ |
(11.33 |
) |
$ |
(36.27 |
) |
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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9,563,986 |
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663,406 |
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2,907,542 |
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660,893 |
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Investor Contact:
(206) 736-7946
ir@silverbacktx.com
Media Contact:
(619) 849-6005
jason.spark@canalecomm.com
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