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, 2023 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 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other jurisd ...

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, 2023 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 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other juris ...

Product Overview - nef y is a novel, potentially first-in-class product candidate for emergency treatment of Type I allergic reactions, including anaphylaxis, utilizing a nasal spray delivery method[18]. - nef y demonstrated comparable pharmacokinetics and pharmacodynamics to approved epinephrine injectables in clinical trials, with zero critical dosing errors reported[29]. - nef y is designed to provide injection-like absorption of epinephrine at doses of 1.0 or 2.0 mg, comparable to the 0.3 mg injection, in a user-friendly nasal spray format[58]. - The 2.0 mg nef y dose is designed to be comparable to the approved 0.3 mg epinephrine products, representing approximately 80% of prescriptions in the U.S.[63]. - Clinical studies showed that 2.0 mg nef y provided comparable pharmacokinetic parameters to approved injection products, with no serious treatment-related adverse events reported[64][66]. - Over 600 subjects have been exposed to nef y across clinical trials, with no significant pain or irritation observed during administration[66]. - nef y has a shelf-life comparable to EpiPen, with stability data showing it remains effective even at high temperatures for extended periods[69]. Market Opportunity - Approximately 25 to 40 million people in the U.S. experience Type I allergic reactions, with only 3.3 million having an active epinephrine autoinjector prescription[20]. - Estimated net sales of intra-muscular injectable products in the U.S. was approximately $1 billion in 2021 among the 3.3 million patients who filled a prescription[25]. - If approved, nef y aims to target at least 45% of healthcare professionals currently prescribing epinephrine, reaching approximately 3.3 million patients who filled a prescription for epinephrine in 2021[40]. - The company plans to expand the market opportunity for nef y to include an additional 2.5 million patients who have refused or discontinued treatment, and 11 million patients diagnosed but not prescribed epinephrine[40]. - The potential for nef y to capture the market includes targeting the 22 million eligible Type I allergy patients who do not currently fill their epinephrine prescriptions[80]. - The epinephrine intra-muscular injectables market presents a significant opportunity, with approximately 11 million diagnosed patients not currently prescribed an epinephrine device, in addition to 9 million patients not under physician care[86]. - In Europe and Japan, sales of epinephrine injectable devices are approximately $160 million, with an estimated additional 15 million patients in Europe and over 30 million in Asia experiencing Type I allergic reactions suitable for nef y[89]. Regulatory and Development Status - The NDA for nef y was accepted for review by the FDA in Q4 2022, with an anticipated mid-2023 PDUFA target action date[22]. - The company plans to submit a supplemental NDA for nef y for children weighing 15 to 30 kilograms in 2023[38]. - The company has filed a MAA for nef y in Europe and plans to submit regulatory filings in Japan and China in collaboration with local partners[40]. - Clinical studies are being conducted to support the expansion of nef y's labeling for outpatient epinephrine use in other Type I allergy conditions[40]. - The FDA accepted the company's NDA for nef y in Q4 2022, with a PDUFA target action date anticipated in mid-2023[40]. Financial Overview - The company has raised over $360 million since inception, including equity financing and licensing agreements[35]. - The company has incurred net losses of approximately $34.7 million and $20.2 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $76.9 million as of December 31, 2022[203]. - The company has never generated revenue from product sales and does not expect to do so until regulatory approval and successful commercialization of its product candidate, nef y[206]. - The company anticipates significant increases in expenses related to regulatory approvals and commercialization efforts for nef y, which is currently in clinical development[210]. - Future capital requirements are uncertain and depend on various factors, including the costs of clinical trials and commercialization activities for nef y[211]. - The company believes its existing cash and cash equivalents will fund operations for at least three years, but this estimate may prove incorrect[212]. - The company may need to seek additional funding, which could lead to dilution of stockholder interests and restrict operations[214]. Partnerships and Collaborations - The company has partnerships for nef y's development and commercialization in Japan and China, with plans for further expansion in pediatric labeling[37]. - The company has entered into licensing agreements for nef y in Japan and China, and plans to pursue additional strategic partnerships for commercialization in other regions[101]. - Aegis received an upfront license fee of $50,000 and is entitled to development milestone payments of up to $3.95 million and commercialization milestone payments up to $16.0 million for each Aegis Licensed Product[121]. - The collaboration with Alfresa includes a one-time upfront payment of $2.0 million and potential regulatory milestones of up to $8.0 million, with a negotiable transfer price expected to be in the low double-digit percentage on net sales[125]. - The agreement with Pediatrix includes a one-time upfront payment of $3.0 million and potential net sales milestone payments of up to $80.0 million, with tiered royalties on net sales increasing to low-to-mid double-digit percentages[128]. Manufacturing and Supply Chain - The company relies on third-party contract manufacturing organizations for the production of nef y and plans to secure a second source of active pharmaceutical ingredient (API) for commercial supply[107][110]. - Renaissance Pharmaceuticals is the primary source for drug product manufacturing and has sufficient capacity to meet long-term requirements[113]. - The manufacturing agreement with Renaissance includes a commitment to purchase a mid double-digit percentage of annual aggregate product requirements in the EU and a high double-digit percentage in the U.S.[130]. Compliance and Regulatory Challenges - The FDA requires extensive regulation for drug development, including research, testing, manufacturing, and marketing, which can significantly impact time and financial resources[132]. - The NDA process requires substantial data to establish safety and effectiveness, with a typical review goal of ten months from the filing date for new molecular entities[145]. - The FDA may request additional information before accepting an NDA for filing, which can delay the review process[145]. - Compliance with cGMP requirements is essential for the manufacturing process to ensure the product's identity, strength, quality, and purity[146]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained, leading to potential market withdrawal or recalls[155]. Market and Pricing Regulations - The company must navigate varying reimbursement policies among third-party payors, which can significantly impact coverage and reimbursement for its pharmaceutical products[172]. - Legislative changes, such as the ACA, have increased Medicaid rebates and imposed new pricing methodologies that affect the pharmaceutical industry[176]. - The Inflation Reduction Act of 2022 introduces provisions for negotiating drug prices under Medicare, which may significantly impact the company's pricing strategies[180]. - The company is required to report price metrics to the government, including Medicaid Average Manufacturer Price and Best Price, affecting its financial reporting[174]. - The company may face heightened scrutiny regarding its pricing practices due to recent executive orders and proposed legislation aimed at increasing transparency in drug pricing[180]. Company Structure and Employment - The company completed a reverse merger with ARS Pharmaceuticals, Inc. on November 8, 2022, changing its name to ARS Pharmaceuticals, Inc. following the merger[200]. - As of December 31, 2022, the company had 17 full-time employees and 3 part-time employees, with 2 holding Ph.D. or M.D. degrees[201].

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 ...

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 Silverback Therapeutics, Inc. For the fiscal year ended December 31, 2021 (Exact name of Registrant as specified in its Charter) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or organization) For the transition period from to Commission F ...

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 ...