Fleming et al. J Allergy Clin Immunol Pract (2014), 4 E. Andrew et al. Prehospital Emergency Care (2018), 5 Data on file from ARS market research NO TREATMENT AVAILABLE ~25% - 50%1, 3, 5 do not administer ~40 - 60%2 of patients delay 1 2 3 4 • Same shelf-life as EpiPen, but also stable at high temperatures • ~10% of cases require multiple doses of epinephrine1 • No risk of needle-related injuries; lacerations2 or cardiotoxic blood vessel injections • 0% critical dosing errors in registration self-administra ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 500 Fairview Ave N, Suite 600 Seattle, Washington 98109 (Address of principal executive offices) (Zip ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 Silverback Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other ju ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 Silverback Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other j ...

Intellectual Property Risks - The company relies on a combination of patents, know-how, and confidentiality agreements to protect its intellectual property [314]. - The success of the company is largely dependent on obtaining and maintaining patent protection for its technologies and product candidates [315]. - The patent application process is expensive and time-consuming, with uncertainties regarding the issuance and enforcement of patents [316]. - The company may face challenges in protecting its intellectual property rights globally, particularly in jurisdictions with weaker enforcement [326]. - Competitors may independently develop technologies that the company protects as trade secrets, potentially undermining its competitive advantage [321]. - The patent position of biopharmaceutical companies is highly uncertain and subject to complex legal challenges [319]. - The company may not be able to prevent unauthorized disclosure of its intellectual property, which could adversely affect its market position [321]. - The company faces uncertainties regarding the protection of its intellectual property rights, which may not adequately safeguard its competitive advantage [327]. - There is a risk that pending patent applications may not lead to issued patents, potentially impacting the company's ability to commercialize its product candidates [332]. - The company relies on licensing agreements, and failure to comply with these agreements could result in significant delays and costs in product development [331]. - The company may need to obtain additional licenses for third-party technology, which may not be available on commercially reasonable terms, potentially hindering product development [338]. - The company is exposed to potential litigation regarding intellectual property rights, which could be costly and time-consuming, affecting its ability to commercialize products [342]. - The company may face challenges in enforcing its patent rights, which could lead to competitors marketing similar products [341]. - The company has identified third-party patents that may be asserted against its product candidate SBT8230, which could impact its commercialization efforts [343]. - The company may incur significant royalty obligations on future product sales, which could affect its profitability [336]. - The company may not be aware of all relevant third-party patents, which could lead to unintentional infringement and associated legal challenges [345]. - The company may choose to challenge the validity of third-party patents, but such proceedings are expensive and may divert resources from core business activities [346]. - The company may face significant legal challenges if found to infringe third-party intellectual property rights, potentially leading to substantial monetary damages and operational disruptions [347]. - The company could incur high costs and time delays in enforcing its patents against competitors, which may divert management and scientific personnel's attention [349]. - Changes in U.S. patent law, such as the Leahy-Smith Act, could increase uncertainties and costs related to patent prosecution and enforcement, adversely affecting the company's financial condition [356]. - The company may struggle to maintain patent protection due to procedural non-compliance, which could result in the loss of patent rights [360]. - Reliance on trade secrets and proprietary know-how poses risks, as any disclosure or misappropriation could enable competitors to replicate the company's technological advancements [361]. - The company may face challenges in protecting trade secrets and proprietary information, which could lead to competitors gaining access to critical technology [362]. - There is a risk of claims challenging the inventorship or ownership of patents, which could result in the loss of valuable intellectual property rights [364]. - The company’s licensors may not be the sole owners of in-licensed patents, potentially allowing competitors to market similar products [365]. - Patent terms may be inadequate to protect the company’s competitive position, as patents generally expire 20 years after the first effective filing date [368]. Financial and Market Risks - Future changes in financial accounting standards may lead to unexpected revenue fluctuations and affect reported financial results [311]. - Changes in tax laws could materially impact the company's business operations, cash flow, and financial performance [312]. - The potential for significant one-time charges and increased future tax expenses exists due to changes in tax legislation [312]. - The stock price of the company could be volatile due to various factors, including clinical trial results and regulatory developments [373]. - As of December 31, 2021, the company had 35,133,934 outstanding shares of common stock, which could impact stock price if substantial sales occur [378]. - Economic instability and market conditions, exacerbated by the COVID-19 pandemic, may adversely affect the company’s financial performance and stock price [379]. - The lack of coverage or unfavorable research from analysts could negatively impact the trading price and volume of the company’s common stock [380]. - Future capital raises may lead to substantial dilution for existing stockholders, potentially causing stock price declines [382]. - The 2020 Plan allows for automatic annual increases in the number of shares reserved for issuance, which could further dilute stockholder ownership [383]. - Additional capital may be sought through equity offerings or debt financings, which could adversely affect stockholder rights and operational flexibility [384]. - The company does not intend to pay dividends, limiting returns to stock appreciation [385]. - The company is subject to securities class action litigation, which could result in significant costs and management distraction [386]. - As an "emerging growth company," the company benefits from reduced reporting requirements, which may affect stock attractiveness [387]. - The company has not opted out of Delaware's anti-takeover provisions, which could hinder potential mergers or acquisitions [393]. - Exclusive forum provisions may limit stockholders' ability to bring claims in favorable jurisdictions, potentially discouraging litigation [397]. Cybersecurity and Operational Risks - The company relies on third-party contractors for sensitive data management, which poses risks of data breaches and operational disruptions [399]. - The company faces significant cybersecurity threats, including ransomware attacks and supply-chain vulnerabilities, which could disrupt operations and lead to data loss [400]. - Increased risks to information technology systems are attributed to a remote workforce and potential vulnerabilities from past business transactions [403]. - Security incidents could result in unauthorized access to sensitive information, leading to liability and reputational damage [401]. - The company may incur substantial costs related to data privacy and security obligations, including notifications of security incidents [404]. - Natural disasters pose a risk to the company's headquarters and research facilities, potentially impacting business continuity [406]. - The absence of a comprehensive disaster recovery plan may lead to significant expenses and operational disruptions [406]. - The company does not have earthquake insurance, increasing vulnerability to natural disasters [406]. - The frequency and severity of supply-chain attacks have increased, raising concerns about third-party vulnerabilities [400]. - The company may need to modify business activities to protect against security incidents, which could delay product development [403]. - There are no assurances that contractual limitations of liability will sufficiently protect the company from data privacy and security claims [405].

Corporate Presentation February 2022 Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes 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 regarding Silverback Therapeutics, ...

SILVERBA Corporate Presentation November 2021 Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes 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 regarding Silverback Thera ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 Silverback Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or oth ...

SBT6050-101: Phase 1/1B Interim Clinical Study Update Investor Presentation at the European Society of Medical Oncology 2021 September 16, 2021 Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any ...

```markdown PART I FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Silverback Therapeutics, Inc.'s unaudited condensed financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, for periods ending June 30, 2021 [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) The company's balance sheet reflects a decrease in **total assets** and **stockholders' equity**, alongside an increase in **total liabilities** Condensed Balance Sheet Data (in thousands) | Financial Metric | June 30, **2021** (in thousands) | December 31, **2020** (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | **$359,689** | **$386,569** | | Total current assets | **$363,027** | **$390,656** | | **Total assets** | **$366,976** | **$394,804** | | **Liabilities & Equity** | | | | Total current liabilities | **$15,548** | **$9,601** | | **Total liabilities** | **$17,326** | **$11,927** | | **Total stockholders' equity** | **$349,650** | **$382,877** | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported **significantly increased net losses** for both the three and six-month periods ending June 30, **2021**, driven by substantial growth in **operating expenses** Quarterly Operating Expense and Net Loss Comparison (in thousands) | Metric (in thousands) | Q2 **2021** | Q2 **2020** | % Change | | :--- | :--- | :--- | :--- | | Research and development | **$17,749** | **$5,126** | **246%** | | General and administrative | **$6,762** | **$1,337** | **406%** | | **Total operating expenses** | **$24,511** | **$6,463** | **279%** | | **Net loss** | **($24,496)** | **($6,467)** | | | Net loss per share | **($0.70)** | **($9.65)** | | Six-Month Operating Expense and Net Loss Comparison (in thousands) | Metric (in thousands) | Six Months **2021** | Six Months **2020** | % Change | | :--- | :--- | :--- | :--- | | Research and development | **$29,988** | **$9,540** | **214%** | | General and administrative | **$13,408** | **$2,165** | **519%** | | **Total operating expenses** | **$43,396** | **$11,705** | **271%** | | **Net loss** | **($43,363)** | **($11,746)** | | | Net loss per share | **($1.25)** | **($17.54)** | | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) **Net cash used in operating activities increased significantly** for the six months ended June 30, **2021**, leading to a net decrease in cash, contrasting with the prior year's financing-boosted cash inflow Condensed Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, **2021** | Six Months Ended June 30, **2020** | | :--- | :--- | :--- | | **Net cash used in operating activities** | **($26,336)** | **($13,071)** | | Net cash used in investing activities | **($735)** | **($38)** | | **Net cash provided by financing activities** | **$191** | **$33,248** | | **Change in cash, cash equivalents, and restricted cash** | **($26,880)** | **$20,139** | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes provide detailed explanations of accounting policies, business nature, **IPO** completion, and management's assessment of cash **sufficiency** for future operations - **Silverback** is a **clinical-stage biopharmaceutical company** focused on its proprietary **ImmunoTAC technology platform** to develop therapeutics for cancer, chronic viral infections, and other serious diseases[23](index=23&type=chunk) - The company completed its **IPO** on December **8**, **2020**, raising **net proceeds** of **$255.3 million**[24](index=24&type=chunk) - As of June **30**, **2021**, the company had an **accumulated deficit** of **$140.1 million** but held **$360.0 million** in **cash, cash equivalents, and restricted cash**, which is considered **sufficient** to fund operations for at least the next **12 months**[27](index=27&type=chunk) - **Accrued research and development expenses increased significantly** from **$2.1 million** at year-end **2020** to **$9.7 million** as of June **30**, **2021**[50](index=50&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results of operations, detailing **increased operating expenses** and confirming strong liquidity post-**IPO** [Overview](index=19&type=section&id=Overview) **Silverback** is a **clinical-stage biopharmaceutical company** developing tissue-targeted therapeutics, with its lead candidate **SBT6050** in **Phase 1/1b trials** and a history of **significant operating losses** - Lead product candidate **SBT6050** is in a **Phase 1/1b clinical trial** for HER2-expressing solid tumors, with an interim update anticipated at the ESMO **2021** Annual Meeting[80](index=80&type=chunk) - The company plans to submit an **investigational new drug (IND) application** for its second product candidate, **SBT6290**, in the fourth quarter of **2021**[80](index=80&type=chunk) - The company has incurred **significant operating losses** since inception, with an **accumulated deficit** of **$140.1 million** as of June **30**, **2021**[82](index=82&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) **Operating expenses increased significantly** in **2021** compared to **2020**, driven by advancing **clinical** and preclinical programs (**SBT6050**, **SBT6290**, **SBT8230**), increased headcount, and public company costs Quarterly Operating Expense and Net Loss Comparison (in thousands) | Expense Comparison (in thousands) | Q2 **2021** | Q2 **2020** | % Change | | :--- | :--- | :--- | :--- | | Research and development | **$17,749** | **$5,126** | **246%** | | General and administrative | **$6,762** | **$1,337** | **406%** | | **Total operating expenses** | **$24,511** | **$6,463** | **279%** | Six-Month Operating Expense and Net Loss Comparison (in thousands) | Expense Comparison (in thousands) | Six Months **2021** | Six Months **2020** | % Change | | :--- | :--- | :--- | :--- | | Research and development | **$29,988** | **$9,540** | **214%** | | General and administrative | **$13,408** | **$2,165** | **519%** | | **Total operating expenses** | **$43,396** | **$11,705** | **271%** | [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position is strong, with current cash reserves deemed **sufficient** to fund operations for at least the next **24 months**, though future funding will be required - The company had **$360.0 million** in **cash, cash equivalents, and restricted cash** as of June **30**, **2021**[103](index=103&type=chunk) - Management believes current cash reserves will be **sufficient** to fund operations and capital expenditures through at least the next **24 months**[109](index=109&type=chunk) - **Net cash used in operating activities** for the first six months of **2021** was **$26.3 million**, primarily due to a **net loss** of **$43.4 million**, offset by non-cash charges like stock-based compensation[103](index=103&type=chunk)[104](index=104&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is **not applicable** as the company qualifies as a "**smaller reporting company**" under SEC regulations - The company is a "**smaller reporting company**" as defined under Item **10(f)(1)** of Regulation S-K, and therefore this disclosure is **not applicable**[120](index=120&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's **disclosure controls and procedures** were effective as of June **30**, **2021**, with **no material changes** to **internal control over financial reporting** - Based on an evaluation as of June **30**, **2021**, the CEO and CFO concluded that the company's **disclosure controls and procedures** were effective[121](index=121&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter ended June **30**, **2021**, that materially affected, or are reasonably likely to materially affect, **internal controls**[122](index=122&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is **not currently a party to any material legal proceedings**, though it may become involved in claims arising in the ordinary course of business - The company is **not currently a party to any material legal proceedings**[124](index=124&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous risks related to the company's business, product development, manufacturing, intellectual property, and common stock ownership [Risks Related to Business and Industry](index=28&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The company faces **significant business risks** including a **limited operating history**, expected continued **net losses**, **substantial capital** requirements, and potential impacts from the **COVID-19 pandemic** - The company has a **limited operating history**, has incurred **net losses** since inception, and expects to incur **significant losses** for the foreseeable future[126](index=126&type=chunk) - The company will need to raise **substantial additional capital** to complete the development and commercialization of its product candidates, as current cash is **not sufficient** to fund any product through regulatory approval[131](index=131&type=chunk)[132](index=132&type=chunk) - The **COVID-19 pandemic** could continue to **adversely impact** business, including delays in **clinical trials**, **supply chain disruptions**, and limitations on employee resources[137](index=137&type=chunk)[138](index=138&type=chunk) [Risks Related to Discovery, Development and Regulatory Approval](index=32&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) The company's early-stage development efforts involve lengthy, expensive, and uncertain processes with **high failure rates**, compounded by novel technology and potential **adverse events** - The company is in early-stage development with only one product candidate, **SBT6050**, in **clinical trials**, and a **limited history** of conducting human trials[143](index=143&type=chunk) - Product candidates are based on **novel technologies** (**ImmunoTAC**), making it difficult to predict the timing, results, and cost of development and the likelihood of regulatory approval[152](index=152&type=chunk) - **Serious adverse events** or **undesirable side effects** could lead to the **discontinuation** of **clinical programs** or **refusal** by regulators to approve product candidates[160](index=160&type=chunk) - The company may be required to develop and obtain approval for a **companion diagnostic** for its product candidates (e.g., for **Nectin4**), which could **delay or prevent commercialization**[175](index=175&type=chunk) [Risks Related to Manufacturing, Commercialization and Reliance on Third Parties](index=38&type=section&id=Risks%20Related%20to%20Manufacturing%2C%20Commercialization%20and%20Reliance%20on%20Third%20Parties) The company relies heavily on third parties (**CROs** and **CDMOs**) for **clinical trial** conduct and manufacturing, facing risks of delays, quality issues, and challenges in market acceptance or favorable pricing for approved products - The company is **dependent on third-party CROs** to conduct **clinical trials** and **third-party CDMOs** for manufacturing, creating risks related to quality, timing, and regulatory compliance (**GLP**, **GCP**, **cGMP**)[190](index=190&type=chunk)[193](index=193&type=chunk) - Manufacturing antibody drug conjugate products is **complex** and may encounter **difficulties in production**, scale-up, and stability, potentially delaying or preventing supply for trials or commercial sale[196](index=196&type=chunk) - Approved products may **fail to achieve market acceptance** from physicians, patients, and payors, and may face **unfavorable pricing** or **reimbursement policies**, **hindering profitability**[201](index=201&type=chunk)[202](index=202&type=chunk) [Risks Related to Our Intellectual Property](index=44&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on robust **intellectual property protection**, facing risks of patent challenges, **in-license breaches**, infringement litigation, and **trade secret misappropriation** - The company's ability to successfully commercialize its products is at risk if it cannot obtain and maintain **sufficient patent protection** for its platform technologies and product candidates[276](index=276&type=chunk) - The company relies on an **in-license agreement** with **WuXi Biologics** for a cell line used to manufacture components of **SBT6050**. A **breach of this agreement** could result in **loss of rights** and **adversely affect** the program[293](index=293&type=chunk) - The company could be sued for **infringing** the **intellectual property rights** of third parties, which could be **costly**, **time-consuming**, and **prevent or delay** the commercialization of product candidates[303](index=303&type=chunk) - The company also relies on **trade secrets**, which are difficult to protect and could be disclosed or misappropriated, **harming its competitive position**[321](index=321&type=chunk) [Risks Related to the Securities Markets and Ownership of Our Common Stock](index=54&type=section&id=Risks%20Related%20to%20the%20Securities%20Markets%20and%20Ownership%20of%20Our%20Common%20Stock) Ownership of the company's common stock involves risks including **high price volatility**, **significant control** by principal stockholders, potential **dilution** from future sales, and reduced attractiveness as an **emerging growth company** - The price of the company's common stock is subject to **extreme volatility**, which is common for biotechnology and pharmaceutical companies[331](index=331&type=chunk) - Principal stockholders and management own a **significant percentage** of the stock and can exert **significant control** over matters subject to stockholder approval[334](index=334&type=chunk) - Future sales and issuances of common stock, including under equity incentive plans, could result in **additional dilution** to stockholders and cause the **stock price to fall**[339](index=339&type=chunk) - The company is an "**emerging growth company**" and intends to take advantage of **reduced reporting requirements**, which may make its common stock **less attractive** to some investors[344](index=344&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the use of proceeds from the company's December **2020** **Initial Public Offering**, confirming **no material change** in the planned use of funds - The company's **IPO** in December **2020** generated **net proceeds** of **$255.3 million**[360](index=360&type=chunk) - Through June **30**, **2021**, the company has used approximately **$18.0 million** of the **net proceeds** from its **IPO**[361](index=361&type=chunk) [Defaults Upon Senior Securities](index=74&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is **not applicable** to the company - **Not applicable**[362](index=362&type=chunk) [Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is **not applicable** to the company - **Not applicable**[363](index=363&type=chunk) [Other Information](index=74&type=section&id=Item%205.%20Other%20Information) This section is **not applicable** to the company - **Not applicable**[364](index=364&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form **10-Q**, including corporate governance documents and **officer certifications** - The report includes exhibits such as the Amended and Restated Certificate of Incorporation, Bylaws, and **officer certifications** pursuant to the Sarbanes-Oxley Act[366](index=366&type=chunk) ```