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Silverback Therapeutics (SBTX) Investor Presentation - Slideshow
2021-11-19 17:58
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 ...
ARS Pharmaceuticals(SPRY) - 2021 Q3 - Quarterly Report
2021-11-10 21:23
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 ...
Silverback Therapeutics (SBTX) presents at ESMO Congress 2021
2021-09-27 20:59
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 ...
ARS Pharmaceuticals(SPRY) - 2021 Q2 - Quarterly Report
2021-08-12 20:37
```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) ```
Silverback Therapeutics (SBTX) Investor Presentation - Slideshow
2021-07-16 20:46
| --- | --- | --- | |----------|-------|-------| | | | | | SILVERB/ | | | 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 statement ...
ARS Pharmaceuticals(SPRY) - 2021 Q1 - Quarterly Report
2021-05-13 20:21
Table of Contents 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, 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 ...
Silverback Therapeutics (SBTX) Investor Presentation - Slideshow
2021-04-12 20:48
| --- | --- | --- | |---------|-------|-------| | | | | | SILVERI | | | 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 ...
ARS Pharmaceuticals(SPRY) - 2020 Q4 - Annual Report
2021-03-29 20:13
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 (Sta ...
Silverback Therapeutics (SBTX) Investor Presentation - Slideshow
2021-03-08 12:23
| --- | --- | --- | |---------|-------|-------| | | | | | SILVERI | | | 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 projections and forward-looking statements as of the date of this presentation provided by Silverback Therapeutics, Inc. (the "Company"). The information in this presentation is current only as of its date and may have changed sin ...