1. – 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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  2. – 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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  3. 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
  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 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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  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 announced that the Company will participate in the 2021 Wedbush PacGrow Healthcare Conference from August 10-11, 2021.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, will participate in the "Heavenly (anti)Bodies" panel on Tuesday, August 10, 2021 at 1:10 p.m. ET (10:10 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 2021 Wedbush PacGrow Healthcare Conference from August 10-11, 2021.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, will participate in the "Heavenly (anti)Bodies" panel on Tuesday, August 10, 2021 at 1:10 p.m. ET (10:10 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.

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  6. 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 a clinical supply agreement with Regeneron for Libtayo® (cemiplimab). The supply agreement supports the evaluation of Libtayo®, a PD-1 inhibitor, in combination with SBT6050, 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.

    "SBT6050's unique ability to activate both innate and adaptive…

    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 a clinical supply agreement with Regeneron for Libtayo® (cemiplimab). The supply agreement supports the evaluation of Libtayo®, a PD-1 inhibitor, in combination with SBT6050, 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.

    "SBT6050's unique ability to activate both innate and adaptive immune responses has the potential to enhance and expand the effectiveness of a PD-1 inhibitor in HER2-expressing solid tumors," said Naomi Hunder, M.D., Chief Medical Officer of Silverback. "We are eager to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor, and look forward to working with Regeneron as we begin tumor-specific expansion cohorts."

    In the first quarter of 2021, Silverback initiated treatment in Part 3 of the Phase 1/1b study to evaluate the activity of SBT6050 in combination with a PD-1 inhibitor in dose escalation. 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 cancer ("NSCLC") and gastric cancer.

    Libtayo® is a PD-1 blocking antibody being jointly developed and commercialized by Regeneron and Sanofi. Libtayo® is approved for the first-line treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, for adults with metastatic cutaneous squamous cell carcinoma ("CSCC") or locally advanced CSCC who are not candidates for curative surgery or curative radiation, and for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor ("HHI") or for whom an HHI is not appropriate that is either locally advanced (full approval) or metastatic (accelerated approval).

    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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  7. 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 Raymond James Human Health Innovation Conference.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, will provide a corporate overview on Wednesday, June 23rd, 2021, at 3:20 PM ET / 12:20 PM PT. The live webcast of the presentation will be available on Silverback's investor relations website and a replay will be available for 30 days following the event. Members of the 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 Raymond James Human Health Innovation Conference.

    Laura Shawver, Ph.D., Silverback's Chief Executive Officer, will provide a corporate overview on Wednesday, June 23rd, 2021, at 3:20 PM ET / 12:20 PM PT. The live webcast of the presentation will be available on Silverback's investor relations website and a replay will be available for 30 days following the event. 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.

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  8. 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 Goldman Sachs 42nd Annual Global Healthcare Conference.

    Laura Shawver, Ph.D., Chief Executive Officer, and Valerie Odegard, Ph.D., President and Chief Scientific Officer, will represent Silverback at a fireside chat on Tuesday, June 8th, 2021 at 3:50 p.m. ET / 12:50 p.m. PT. The live webcast of the fireside chat will be available on Silverback's investor relations website and a replay…

    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 Goldman Sachs 42nd Annual Global Healthcare Conference.

    Laura Shawver, Ph.D., Chief Executive Officer, and Valerie Odegard, Ph.D., President and Chief Scientific Officer, will represent Silverback at a fireside chat on Tuesday, June 8th, 2021 at 3:50 p.m. ET / 12:50 p.m. PT. The live webcast of the fireside chat will be available on Silverback's investor relations website and a replay will be available for 30 days following the event. 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.

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  9. 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 first quarter ended March 31, 2021 and provided a business update.

    "In our first quarter as a public company, our team continues to execute on Silverback's mission to bring tissue-targeted therapies to patients in need," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are on track to report interim clinical data for SBT6050 in the second half of this year, and we are equally excited…

    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 first quarter ended March 31, 2021 and provided a business update.

    "In our first quarter as a public company, our team continues to execute on Silverback's mission to bring tissue-targeted therapies to patients in need," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are on track to report interim clinical data for SBT6050 in the second half of this year, and we are equally excited about the progress and preclinical data emerging from SBT6290 and SBT8230, highlighting the broad applicability of our ImmunoTAC platform."

    Recent Highlights

    • SBT6050 (HER2-TLR8 ImmunoTAC) continues to advance through monotherapy and pembrolizumab combination dose escalation arms of the Phase 1/1b clinical study. Silverback is on track to deliver interim clinical data from the monotherapy dose escalation arm of the study in the second half of 2021.
    • GLP toxicology studies have commenced for SBT6290 (Nectin4-TLR8 ImmunoTAC), with an IND submission anticipated in the fourth quarter of 2021. Dosing has been initiated in the GLP toxicology study and GMP manufacturing of the Phase 1 clinical supply is underway. In April 2021, Silverback presented data at the American Association of Cancer Research Annual Meeting 2021. These preclinical data showed 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.
    • SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with CMC activities underway. GLP toxicology studies are expected to commence in the first quarter of 2022.
    • Appointed Maria Koehler, M.D., Ph.D. to Board of Directors. In March 2021, Silverback appointed Dr. Koehler, M.D., Ph.D. to its board of directors, bringing more than 20 years of clinical development leadership experience.

    First Quarter Financial Results

    For the first quarter ended March 31, 2021, Silverback reported a net loss of $18.9 million, compared to a net loss of $5.3 million for the comparable period in 2020. Net loss for the first quarter of 2021 included non-cash stock-based compensation expense of $4.3 million compared to $47,000 for the same period in 2020.

    Research and development expenses for the first quarter ended March 31, 2021 were $12.2 million, compared to $4.4 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, into preclinical development and the continued development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advances.

    General and administrative expenses for the first quarter ended March 31, 2021 were $6.6 million, compared to $0.8 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 2020, 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 March 31, 2021, Silverback reported cash and cash equivalents of $374.2 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)

     

     

    March 31,

     

     

    December 31,

     

     

    2021

     

     

    2020

     

     

    (unaudited)

     

     

     

     

    Assets

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

    Cash and cash equivalents

    $

    374,205

     

     

     

    $

    386,569

     

    Prepaid expenses and other current assets

     

    4,141

     

     

     

     

    4,087

     

    Total current assets

     

    378,346

     

     

     

     

    390,656

     

    Property and equipment, net

     

    1,603

     

     

     

     

    1,618

     

    Restricted cash

     

    350

     

     

     

     

    350

     

    Right-of-use asset

     

    1,900

     

     

     

     

    2,180

     

    Total assets

    $

    382,199

     

     

     

    $

    394,804

     

    Liabilities, and stockholders' equity

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

    Accounts payable

    $

    4,374

     

     

     

    $

    2,583

     

    Accrued expenses

     

    5,799

     

     

     

     

    5,278

     

    Term loan payable, net

     

    495

     

     

     

     

    844

     

    Current portion of lease liability

     

    927

     

     

     

     

    896

     

    Total current liabilities

     

    11,595

     

     

     

     

    9,601

     

    Lease liability, net of current portion

     

    2,055

     

     

     

     

    2,326

     

    Total liabilities

     

    13,650

     

     

     

     

    11,927

     

    Commitments and contingencies

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

     

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

     

     

     

     

     

     

    Common stock, $0.0001 par value per share; 200,000,000 shares authorized at March 31, 2021 and December 31, 2020, 34,903,497 and 34,801,537 shares issued, and 34,827,204 and 34,701,274 shares outstanding at March 31, 2021 and December 31, 2020, respectively

     

    3

     

     

     

     

    3

     

    Additional paid-in capital

     

    484,147

     

     

     

     

    479,608

     

    Accumulated deficit

     

    (115,601

    )

     

     

     

    (96,734

    )

    Total stockholders' equity

     

    368,549

     

     

     

     

    382,877

     

    Total liabilities, and stockholders' equity

    $

    382,199

     

     

     

    $

    394,804

     

     

    Silverback Therapeutics, Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share data)

    (unaudited)

     

     

    Three Months Ended March 31,

     

     

    2021

     

     

    2020

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    $

    12,239

     

     

     

    $

    4,414

     

     

    General and administrative

     

    6,646

     

     

     

     

    828

     

     

    Total operating expenses

     

    18,885

     

     

     

     

    5,242

     

     

    Loss from operations

     

    (18,885

    )

     

     

     

    (5,242

    )

     

    Interest income (expense), net

     

    18

     

     

     

     

    (37

    )

     

    Net loss and comprehensive loss

    $

    (18,867

    )

     

     

    $

    (5,279

    )

     

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

    $

    (0.54

    )

     

     

    $

    (7.89

    )

     

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

     

    34,773,950

     

     

     

     

    669,033

     

     

     

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  10. 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…

    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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  11. 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…

    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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  12. 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…

    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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  13. 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:

    • 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

    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:

    • 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.

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  14. 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…

    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 prospectus-ny@ny.email.gs.com; 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 syndicate@svbleerink.com; 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 syndprospectus@stifel.com.

    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.

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