Silverback Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update
“The second quarter was notable for the significant progress we made across our entire pipeline of tissue-targeted therapies, with SBT6050, our HER2-TLR8 ImmunoTAC leading the way with continued robust enrollment in our Phase 1/1b study,” said
Recent Highlights
-
SBT6050 (HER2-TL8 ImmunoTAC) clinical abstract accepted for poster presentation at the
European Society for Medical Oncology (“ESMO”) 2021 Annual Meeting. The presentation will provide an update on the monotherapy dose-escalation arm (Part 1) and the pembrolizumab combination dose-escalation arm (Part 3) of the SBT6050-101 Phase 1/1b study. Details of the upcoming ESMO poster presentation are as follows:
Title: “Interim results of a Phase 1/1b study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors” Klempner, S., et al.
Poster Number: 209P
Session Date and Time: The ePoster will be released virtually onThursday, September 16 th at8:30 AM Central EuropeanSummer Time /2:30 AM Eastern Standard Time - Announced a clinical supply agreement with Regeneron to evaluate SBT6050 in combination with Libtayo® (cemiplimab), a PD-1 inhibitor. Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo® in tumor-specific dose expansion cohorts, initially in HER2-expressing non-small cell lung and gastric cancers.
- GLP toxicology study for SBT6290 (Nectin4-TLR8 ImmunoTAC) is nearing completion, with IND filing on track for the fourth quarter of 2021. Dosing was initiated in the GLP toxicology study in the second quarter and cGMP manufacturing of the drug product for Phase 1 clinical supply has been completed, with release testing in progress.
- SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with early CMC activities initiated including selection of the clone and creation of a master cell bank. The GLP toxicology study is expected to commence in the first quarter of 2022.
Second Quarter Financial Results
For the second quarter ended
Research and development expenses for the second quarter ended
General and administrative expenses for the second 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 our intentions, beliefs, projections, outlook, analyses or current expectations concerning, 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, risks associated with the impact of the COVID-19 pandemic on our business and the global economy, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with losing key members of management 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
Condensed Balance Sheets (in thousands, except share and par value data) |
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2021 |
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2020 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
359,689 |
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$ |
386,569 |
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Prepaid expenses and other current assets |
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3,338 |
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4,087 |
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Total current assets |
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363,027 |
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390,656 |
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Property and equipment, net |
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1,984 |
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1,618 |
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Restricted cash |
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350 |
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350 |
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Right-of-use asset |
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1,615 |
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2,180 |
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Total assets |
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$ |
366,976 |
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$ |
394,804 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,805 |
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$ |
2,583 |
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Accrued expenses |
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12,785 |
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5,278 |
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Term loan payable, net |
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— |
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844 |
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Current portion of lease liability |
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958 |
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896 |
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Total current liabilities |
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15,548 |
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9,601 |
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Lease liability, net of current portion |
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1,778 |
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2,326 |
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Total liabilities |
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17,326 |
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11,927 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred Stock, |
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— |
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— |
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Common stock, |
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4 |
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3 |
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Additional paid-in capital |
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489,743 |
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479,608 |
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Accumulated deficit |
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(140,097 |
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(96,734 |
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Total stockholders’ equity |
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349,650 |
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382,877 |
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Total liabilities, and stockholders’ equity |
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$ |
366,976 |
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$ |
394,804 |
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Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
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Three Months Ended
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Six Months Ended
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
17,749 |
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$ |
5,126 |
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29,988 |
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$ |
9,540 |
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General and administrative |
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6,762 |
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1,337 |
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13,408 |
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2,165 |
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Total operating expenses |
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24,511 |
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6,463 |
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43,396 |
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11,705 |
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Loss from operations |
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(24,511 |
) |
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(6,463 |
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(43,396 |
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(11,705 |
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Interest income (expense), net |
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15 |
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(4 |
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33 |
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(41 |
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Net loss and comprehensive loss |
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(24,496 |
) |
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(6,467 |
) |
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(43,363 |
) |
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$ |
(11,746 |
) |
Net loss per share applicable to common stockholders, basic and diluted |
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$ |
(0.70 |
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$ |
(9.65 |
) |
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$ |
(1.25 |
) |
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$ |
(17.54 |
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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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34,876,050 |
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670,451 |
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34,825,281 |
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669,742 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20210812005212/en/
Investor Contact:
(206) 736-7946
ir@silverbacktx.com
Media Contact:
(619) 849-6005
jason.spark@canalecomm.com
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