EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe Same data package under review by FDA with a PDUFA date of October 2, 2024 "Today's announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis," sai ...

Same data package under review by FDA with a PDUFA date of October 2, 2024 Following grant of marketing authorization by the EC expected in Q3 2024, ARS Pharma anticipates that EURneffy will be made available to patients in Europe in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe. About ARS Pharmaceuticals, Inc. ARS Investor Contact: Justin Chakma ARS Pharmaceuticals justinc@ars-pharma.com "Today's announcement marks a major milestone in the treatment of sever ...

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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | Trading | Name of each exchange | | --- | --- | --- | | Title of each class | Symbol(s) | on which registered | | Common Stock, par value $0.0001 per | SPRY | The Nasdaq Stock Market LL ...

Exhibit 99.1 Global Regulatory Status of neffy ARS Pharmaceuticals Highlights nef y Regulatory Progress and Reports First Quarter 2024 Financial Results neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA's CHMP; CHMP opinion expected in the second quarter of 2024 Preparing to initiate outpatient study of neffy for urticaria (hive ...

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, 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 jurisdicti ...

SAN DIEGO -- March 21, 2024 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023. "We started the year by turning the page and quickly addressing the two deficiencies identified in the FDA's CRL for neffy late last year and are now working to finaliz ...

PART I FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the nine months ended September 30, 2023, detailing a **$47.2 million net loss**, **$241.9 million in cash and equivalents**, and key operational changes Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,532 | $210,518 | | Short-term investments | $181,370 | $63,863 | | **Total Current Assets** | **$244,466** | **$277,700** | | **Total Assets** | **$248,556** | **$281,435** | | **Liabilities & Equity** | | | | Total Liabilities | $11,272 | $8,549 | | Accumulated Deficit | ($124,135) | ($76,938) | | **Total Stockholders' Equity** | **$237,284** | **$272,886** | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $189 | $30 | $1,316 | | Research and development | $3,002 | $3,893 | $16,862 | $13,666 | | General and administrative | $14,976 | $2,926 | $40,462 | $7,723 | | **Loss from operations** | **($17,978)** | **($6,630)** | **($57,294)** | **($20,073)** | | **Net loss** | **($14,866)** | **($6,583)** | **($47,197)** | **($20,253)** | | Net loss per share | ($0.16) | ($0.21) | ($0.50) | ($0.66) | Condensed Consolidated Statements of Cash Flows (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($41,861) | ($19,581) | | Net cash used in investing activities | ($113,219) | ($73) | | Net cash provided by (used in) financing activities | $5,094 | ($3,087) | | **Net change in cash and cash equivalents** | **($149,986)** | **($22,741)** | - In September 2023, the company initiated a **20% reduction in force** to conserve cash, incurring **$0.6 million** in termination benefits[32](index=32&type=chunk) - As of September 30, 2023, the company's **$241.9 million** in cash, cash equivalents, and short-term investments are deemed sufficient for at least the next 12 months[33](index=33&type=chunk) - In February 2023, the company terminated its Recordati agreement, reacquiring European rights for a **€3.0 million** upfront payment recorded as IPR&D expense[85](index=85&type=chunk)[86](index=86&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's sole product candidate, nefy, the FDA's Complete Response Letter delaying its launch, and significant increases in operating expenses for pre-commercialization, affirming sufficient capital for three years [Overview](index=26&type=section&id=Overview) This overview details the company's focus on nefy, the FDA's Complete Response Letter requesting an additional study, and the revised timeline for NDA resubmission in H1 2024 and potential U.S. launch in H2 2024 - The FDA issued a Complete Response Letter (CRL) for the nefy NDA, requesting a repeat-dose study under allergen-induced allergic rhinitis conditions[135](index=135&type=chunk) - The company plans to complete the requested study and resubmit the NDA in **H1 2024**, targeting a PDUFA action date in **H2 2024**[137](index=137&type=chunk)[147](index=147&type=chunk) - As of September 30, 2023, the company held **$241.9 million** in cash, cash equivalents, and short-term investments, with an accumulated deficit of **$124.1 million**[139](index=139&type=chunk)[140](index=140&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Operating expenses significantly increased for both three and nine-month periods ended September 30, 2023, primarily driven by higher General & Administrative costs for nefy's pre-commercial launch activities Comparison of Three Months Ended September 30, 2023 and 2022 (in thousands) | Expense Category | 2023 | 2022 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $3,002 | $3,893 | ($891) | Decrease in device component purchases | | General & Administrative | $14,976 | $2,926 | $12,050 | $6.0M increase in pre-commercial launch activities, plus higher payroll and stock-based compensation | Comparison of Nine Months Ended September 30, 2023 and 2022 (in thousands) | Expense Category | 2023 | 2022 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $16,862 | $13,666 | $3,196 | Increase in product materials, stock-based compensation, and payroll | | General & Administrative | $40,462 | $7,723 | $32,739 | $14.9M increase in pre-commercial launch activities, plus higher payroll and stock-based compensation | [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company's operations are funded by merger proceeds and stock sales, holding **$241.9 million** in cash and equivalents as of September 30, 2023, deemed sufficient for at least the next three years - Net cash used in operating activities increased to **$41.9 million** for the nine months ended September 30, 2023, from **$19.6 million** in 2022, driven by a higher net loss[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk) - The company believes existing cash and cash equivalents are sufficient to meet anticipated cash requirements for at least the next **three years**, including funding nefy's commercial launch if approved[172](index=172&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," ARS Pharmaceuticals is exempt from providing quantitative and qualitative disclosures about market risk - The company is exempt from this disclosure requirement due to its status as a "smaller reporting company"[184](index=184&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting - As of September 30, 2023, the CEO and CFO concluded the company's disclosure controls and procedures were effective[185](index=185&type=chunk) - No material changes occurred during the quarter affecting the company's internal control over financial reporting[186](index=186&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in patent-related legal proceedings, including an appeal by Amphastar Pharmaceuticals regarding U.S. Patent No. 10,682,414 and an opposition by Aera A/S against European Patent EP 3678649 - Amphastar Pharmaceuticals appealed a USPTO decision upholding claims of the company's '414 patent covering nefy, with a Federal Circuit decision expected in **2024**[98](index=98&type=chunk) - Aera A/S filed an opposition with the European Patent Office against the company's EP '649 patent for a nasal spray epinephrine formulation[99](index=99&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including dependence on nefy, the FDA's Complete Response Letter, future capital needs, reliance on third parties, market acceptance and reimbursement challenges, and ongoing patent litigation [Risks Related to Financial Position and Capital Needs](index=38&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Capital) The company, a clinical-stage entity, faces ongoing losses with a **$124.1 million** accumulated deficit, and while current cash is sufficient for three years, additional capital for commercialization may be needed, risking dilution - The company has incurred significant losses since inception, with a **$47.2 million** net loss for the nine months ended September 30, 2023, and an accumulated deficit of **$124.1 million**[190](index=190&type=chunk) - The company's business depends entirely on the success of its sole product candidate, nefy; failure to gain regulatory approval and commercialize it would materially harm the business[195](index=195&type=chunk)[207](index=207&type=chunk) - While current cash is expected to fund operations for at least **three years**, significant additional capital may be required for nefy's launch and commercialization, potentially on unfavorable terms[197](index=197&type=chunk)[201](index=201&type=chunk) [Risks Related to Product Development](index=42&type=section&id=Risks%20Related%20to%20the%20Development%20of%20nefy%20or%20Any%20Future%20Product%20Candidates) Primary development risks include regulatory approval uncertainty, highlighted by the FDA's CRL for nefy, potential clinical trial delays or failures, non-acceptance of the 505(b)(2) pathway, and the emergence of undesirable side effects - The FDA issued a Complete Response Letter (CRL) for the nefy NDA, requesting an additional study, which will delay potential commercialization and offers no guarantee of approval upon resubmission[206](index=206&type=chunk) - Reliance on the Section 505(b)(2) regulatory pathway is a risk; a different FDA-required pathway would significantly increase approval time and cost[221](index=221&type=chunk)[223](index=223&type=chunk) - Potential competitors, including Bryn Pharma, Nasus Pharma, and Amphastar, are developing intranasal epinephrine products, which could reduce nefy's commercial opportunity[246](index=246&type=chunk) [Risks Related to Dependence on Third Parties](index=57&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company relies entirely on third parties for manufacturing (e.g., Renaissance), clinical trials (CROs), and international commercialization (e.g., Alfresa Pharma, Pediatrix), creating risks of supply shortages, development delays, and limited control over partner performance - The company relies on third parties, primarily Renaissance Lakewood LLC, for nefy's manufacturing and supply, creating dependence on a single source due to its lack of internal capabilities[267](index=267&type=chunk)[268](index=268&type=chunk) - The company depends on Contract Research Organizations (CROs) for clinical trials; their failure to perform could delay or jeopardize development programs[270](index=270&type=chunk) - International commercialization outside the U.S. relies on partners like Alfresa Pharma (Japan) and Pediatrix Therapeutics (China), whose non-performance could adversely affect the business[273](index=273&type=chunk) [Risks Related to Commercialization](index=61&type=section&id=Risks%20Related%20to%20Commercialization%20of%20nefy%20or%20Any%20Future%20Product%20Candidates) Commercialization risks include the company's lack of experience, the uncertainty of market acceptance for nefy, challenges in securing adequate reimbursement from payors, and compliance with complex healthcare laws - The company has limited marketing, sales, and distribution infrastructure, requiring expensive and time-consuming development to commercialize nefy successfully if approved[279](index=279&type=chunk) - Even if approved, nefy may fail to gain market acceptance from physicians, patients, and payors, who might prefer established injectable products[293](index=293&type=chunk) - Commercial success depends heavily on obtaining favorable coverage and adequate reimbursement from third-party payors, which is uncertain and subject to pricing pressures[305](index=305&type=chunk) [Risks Related to Intellectual Property](index=72&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Commercial success depends on defending intellectual property, as nefy's patents face ongoing legal challenges in the U.S. and Europe, potentially inadequate patent terms, and risks of costly third-party infringement lawsuits - The company's patents face ongoing legal challenges, including a U.S. Inter Partes Review appeal and a European opposition proceeding, risking loss of patent protection[345](index=345&type=chunk)[373](index=373&type=chunk) - Nefy's co-owned or licensed patents are expected to expire as early as **2038**, and if approved via the 505(b)(2) pathway, they will not be eligible for patent term restoration, risking earlier generic competition[360](index=360&type=chunk) - The company may face costly litigation for infringing third-party intellectual property rights, potentially preventing or delaying nefy's commercialization[368](index=368&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the use of **$255.3 million** net proceeds from the December 2020 IPO, with **$143.3 million** utilized by September 30, 2023, for product development, merger costs, and general corporate purposes - The December 2020 IPO generated **$255.3 million** in net proceeds[432](index=432&type=chunk) - As of September 30, 2023, approximately **$143.3 million** of IPO proceeds have been used, including an estimated **$34.8 million** for nefy's development and pre-commercial launch activities[434](index=434&type=chunk) [Other Information](index=93&type=section&id=Item%205.%20Other%20Information) No information is reported under this item for the period - None [Exhibits](index=94&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, officer certifications, and Inline XBRL data files - Exhibits include key corporate governance documents and certifications from the Principal Executive Officer and Principal Financial Officer as required by Sarbanes-Oxley Act Sections 302 and 906[441](index=441&type=chunk)

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].