SBTX Silverback Therapeutics Inc.

9.11
-0.18  -2%
Previous Close 9.29
Open 9.22
52 Week Low 9.1
52 Week High 63.41
Market Cap $319,185,809
Shares 35,036,477
Float 17,656,237
Enterprise Value $-34,967,777
Volume 245,254
Av. Daily Volume 508,484
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Drug Pipeline

Drug Stage Notes
SBT6050 (monotherapy and pembrolizumab)
HER2 Positive Solid Tumors
Phase 1
Phase 1
Phase 1/1b presented at ESMO September 16, 2021. Among 18 evaluable patients for tumor types of interest, 1 patient had a confirmed partial response (5%). In addition, stable disease was reported in 7 patients (38%).
SBT6290
Hepatitis B
Phase 1
Phase 1
Phase 1/1b trial to be initiated in 2022.

Latest News

  1. 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 the Company will participate in the H.C. Wainwright Hepatitis B Virus (HBV) Conference on Wednesday, October 13, 2021.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, and Valerie Odegard, Ph.D., Silverback's President and Chief Scientific Officer, will participate in a fireside chat on Wednesday, October 13, 2021, at 10:30 a.m. ET (7:30 a.m. PT). The live webcast of the presentation will be available on Silverback's…

    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 the Company will participate in the H.C. Wainwright Hepatitis B Virus (HBV) Conference on Wednesday, October 13, 2021.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, and Valerie Odegard, Ph.D., Silverback's President and Chief Scientific Officer, will participate in a fireside chat on Wednesday, October 13, 2021, at 10:30 a.m. ET (7:30 a.m. PT). The live webcast of the presentation will be available on Silverback's investor relations website.

    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.

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  2. – Proof-of-mechanism established with activation of myeloid and T/NK cells, and evidence of SBT6050 payload localization in the tumor microenvironment –

    – SBT6050 demonstrated a manageable safety profile with adverse events consistent with on-mechanism immune activation, both as a monotherapy or in combination with pembrolizumab –

    – Early signals of anti-tumor activity observed in a heavily pre-treated, heterogeneous population –

    – Management to host conference call today at 6:30 AM ET –

    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…

    – Proof-of-mechanism established with activation of myeloid and T/NK cells, and evidence of SBT6050 payload localization in the tumor microenvironment –

    – SBT6050 demonstrated a manageable safety profile with adverse events consistent with on-mechanism immune activation, both as a monotherapy or in combination with pembrolizumab –

    – Early signals of anti-tumor activity observed in a heavily pre-treated, heterogeneous population –

    – Management to host conference call today at 6:30 AM ET –

    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 presented interim clinical results from a Phase 1/1b clinical study of SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors, at the 2021 European Society for Medical Oncology Congress.

    "Over this past year, we have gathered compelling data with clear signals of SBT6050's pharmacological activity, marked by the activation of both the innate and adaptive immune response in patients," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens."

    As of August 1, 2021, 40 patients with advanced or metastatic HER2-expressing or amplified solid tumors were enrolled into the SBT6050-101 trial. SBT6050 dose levels ranged from 0.3 to 1.2 mg/kg in the monotherapy dose escalation arm (Part 1), and 0.15 and 0.3 mg/kg in the pembrolizumab combination arm (Part 3). Patients received between 1 and 17 doses of SBT6050.

    As a monotherapy and in combination with pembrolizumab, SBT6050 was generally well-tolerated, with an adverse event profile that is consistent with immune system activation and considered on-mechanism. "The adverse event profile thus far has been very manageable and importantly, suggests the potential to combine with other standard of care agents," said Samuel Klempner, MD, Medical Oncologist at the Massachusetts General Hospital. "The signals of anti-tumor activity are encouraging and its complementary mechanism of action with standard-of-care agents makes SBT6050 attractive for combination regimens."

    Initial Safety Data

    • The most frequent treatment-related adverse events were consistent with immune activation, and included injection site reactions, fever and chills, hypotension, nausea, vomiting, and fatigue. These were mostly Grade 1 or 2 in nature, and no Grade 4 or higher related adverse events were reported.
    • At higher dose levels, dose limiting toxicities (DLTs) were observed and included Grade 3 hypotension, injection site reaction, fever, and hypoxia. These DLTs resolved with supportive care.
    • Cytokine release syndrome (CRS) > Grade 2 was not observed at any dose level.

    Pharmacokinetic and Pharmacodynamic Data

    • SBT6050 exposures increased with dose and exhibited a linear PK profile at 0.6 mg/kg and higher. Linear exposure is evidence of saturation of receptor mediated clearance.
    • Conjugate stability was assessed using a highly sensitive assay, and no active levels of SBT6050's free payload were detected in the blood and any amount of free payload was absent in 98% of all blood samples tested.
    • SBT6050 induces pharmacologic activity indicative of myeloid and NK/T cell activation at all dose levels, with effects plateauing at 0.6 mg/kg.
    • Pharmacodynamic activity is maintained with repeat dosing of SBT6050.

    Anti-Tumor Activity

    • Early signals of anti-tumor activity were observed in a heavily pre-treated, heterogeneous population.
    • Among 18 evaluable patients for tumor types of interest, one patient with HER2 IHC 2+ NSCLC had a confirmed partial response (-55% per RECIST 1.1 criteria), maintained at the most recently available scan obtained at 36 weeks post-enrollment, and 8 weeks after discontinuing study treatment. In addition, stable disease was reported in seven patients.

    SBT6050 targets the pertuzumab binding domain of HER2 and is designed to be used in combination with standard of care agents, including trastuzumab-containing regimens. Silverback will be discussing details of its expanded clinical development strategy on the scheduled investor webcast today.

    Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

    Silverback's management team will host a conference call today at 6:30 AM ET. A live webcast, including slides, can be accessed through the Events section of the Company's website at https://ir.silverbacktx.com/news-events/events. An archived replay will be available shortly after the conclusion of the event.

    About SBT6050

    SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-containing therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

    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, including potential combination efforts, 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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  3. – Interim monotherapy and initial pembrolizumab combination data from the dose-escalation arm of the SBT6050-101 trial will be reported –

    – Conference call to be held on Thursday, September 16, 2021, at 6:30 AM ET –

    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 interim data from the dose-escalation portion of its Phase 1/1b clinical trial evaluating SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing…

    – Interim monotherapy and initial pembrolizumab combination data from the dose-escalation arm of the SBT6050-101 trial will be reported –

    – Conference call to be held on Thursday, September 16, 2021, at 6:30 AM ET –

    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 interim data from the dose-escalation portion of its Phase 1/1b clinical trial evaluating SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors will be presented at the upcoming European Society for Medical Oncology (ESMO) 2021 Congress from September 16-21, 2021.

    The accepted abstract, with a data cut-off date of April 4, 2021, is now available on the ESMO website. The upcoming poster will include additional data with a cut-off date of August 1, 2021. Details of the poster 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"

    Poster Number: 209P

    Presenter: Samuel J. Klempner, MD

    Session Date and Time: The poster will be released virtually on Thursday, September 16th at 8:30 AM Central European Summer Time / 2:30 AM Eastern Time

    Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

    Silverback's management team will host a conference call on Thursday, September 16, 2021, at 6:30 AM ET following the release of the poster at the ESMO 2021 Virtual Congress. A live webcast, including slides, can be accessed through the Events section of the Company's website at https://ir.silverbacktx.com/news-events/events. An archived replay will be available shortly after the conclusion of the event.

    About SBT6050

    SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-based therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

    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, applications and other interactions with regulatory bodies, the risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with the COVID-19 global pandemic, 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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  4. 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 the Company will participate in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, will provide a corporate overview on Monday, September 13, 2021, at 11:00 a.m. ET (8:00 a.m. PT). Members of the Silverback management team will also host investor meetings during the conference.

    About Silverback Therapeutics

    Silverback…

    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 the Company will participate in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, will provide a corporate overview on Monday, September 13, 2021, at 11:00 a.m. ET (8:00 a.m. PT). Members of the Silverback management team will also host investor meetings during the conference.

    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 Full Article Hide Full Article
  5. 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 for the second quarter ended June 30, 2021 and provided a 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 Laura Shawver, Ph.D., chief executive officer of Silverback. "We are deeply appreciative of…

    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 for the second quarter ended June 30, 2021 and provided a 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 Laura Shawver, Ph.D., chief executive officer of Silverback. "We are deeply appreciative of the patients, their families, and our clinical investigators who continue to contribute to the SBT6050-101 clinical trial, and we look forward to providing the first update of the clinical data at the ESMO conference in September."

    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 on Thursday, September 16th at 8:30 AM Central European Summer 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 June 30, 2021, Silverback reported a net loss of $24.5 million, compared to a net loss of $6.5 million for the comparable period in 2020. For the six months ended June 30, 2021, Silverback reported a net loss of $43.4 million, compared to a net loss of $11.7 million for the comparable period in 2020. Included in the net losses for the three and six months ended June 30, 2021 were $4.7 million and $9.0 million of non-cash stock-based compensation compared to $128,000 and $175,000 for the same periods in 2020.

    Research and development expenses for the second quarter ended June 30, 2021 were $17.7 million, compared to $5.1 million for the same period in 2020. Research and development expenses for the six months ended June 30, 2021 were $30.0 million compared to $9.5 million for the same period in 2020. The increases in the Company's research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, through preclinical development and the continued clinical development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advancements.

    General and administrative expenses for the second quarter ended June 30, 2021 were $6.8 million, compared to $1.3 million for the same period in 2020. General and administrative expenses for the six months ended June 30, 2021 were $13.4 million, compared to $2.2 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

    As of June 30, 2021, Silverback reported cash and cash equivalents of $359.7 million, compared to $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months.

    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 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 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.

    Condensed Balance Sheets

    (in thousands, except share and par value data)

     

     

     

     

    June 30,

     

     

    December 31,

     

     

     

     

    2021

     

     

    2020

     

     

     

     

    (unaudited)

     

     

     

     

    Assets

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

    Cash and cash equivalents

     

     

    $

    359,689

     

     

    $

    386,569

     

    Prepaid expenses and other current assets

     

     

     

    3,338

     

     

     

    4,087

     

    Total current assets

     

     

     

    363,027

     

     

     

    390,656

     

    Property and equipment, net

     

     

     

    1,984

     

     

     

    1,618

     

    Restricted cash

     

     

     

    350

     

     

     

    350

     

    Right-of-use asset

     

     

     

    1,615

     

     

     

    2,180

     

    Total assets

     

     

    $

    366,976

     

     

    $

    394,804

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

    Accounts payable

     

     

    $

    1,805

     

     

    $

    2,583

     

    Accrued expenses

     

     

     

    12,785

     

     

     

    5,278

     

    Term loan payable, net

     

     

     

     

     

     

    844

     

    Current portion of lease liability

     

     

     

    958

     

     

     

    896

     

    Total current liabilities

     

     

     

    15,548

     

     

     

    9,601

     

    Lease liability, net of current portion

     

     

     

    1,778

     

     

     

    2,326

     

    Total liabilities

     

     

     

    17,326

     

     

     

    11,927

     

    Commitments and contingencies

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

     

    Preferred Stock, $0.0001 par value per share; 10,000,000 shares authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding at June 30, 2021 and December 31, 2020

     

     

     

     

     

     

     

    Common stock, $0.0001 par value per share; 200,000,000 shares authorized at June 30, 2021 and December 31, 2020, 34,998,372 and 34,801,537 shares issued, and 34,963,085 and 34,701,274 shares outstanding at June 30, 2021 and December 31, 2020, respectively

     

     

     

    4

     

     

     

    3

     

    Additional paid-in capital

     

     

     

    489,743

     

     

     

    479,608

     

    Accumulated deficit

     

     

     

    (140,097

    )

     

     

    (96,734

    )

    Total stockholders' equity

     

     

     

    349,650

     

     

     

    382,877

     

    Total liabilities, and stockholders' equity

     

     

    $

    366,976

     

     

    $

    394,804

     

    Silverback Therapeutics, Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share data)

    (unaudited)

     

     

     

    Three Months Ended

    June 30,

     

     

    Six Months Ended

    June 30,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    17,749

     

     

    $

    5,126

     

     

     

    29,988

     

     

    $

    9,540

     

    General and administrative

     

     

    6,762

     

     

     

    1,337

     

     

     

    13,408

     

     

     

    2,165

     

    Total operating expenses

     

     

    24,511

     

     

     

    6,463

     

     

     

    43,396

     

     

     

    11,705

     

    Loss from operations

     

     

    (24,511

    )

     

     

    (6,463

    )

     

     

    (43,396

    )

     

     

    (11,705

    )

    Interest income (expense), net

     

     

    15

     

     

     

    (4

    )

     

     

    33

     

     

     

    (41

    )

    Net loss and comprehensive loss

     

     

    (24,496

    )

     

     

    (6,467

    )

     

     

    (43,363

    )

     

    $

    (11,746

    )

    Net loss per share applicable to common stockholders, basic and diluted

     

    $

    (0.70

    )

     

    $

    (9.65

    )

     

    $

    (1.25

    )

     

    $

    (17.54

    )

    Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

     

     

    34,876,050

     

     

     

    670,451

     

     

     

    34,825,281

     

     

     

    669,742

     

     

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