$SPRY
ARS Pharmaceuticals, Inc.

2024 Q2 Form 10-Q Financial Statement

#000095017024056967 Filed on May 09, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2024 Q1
Revenue $500.0K $0.00
YoY Change 4900.0% -100.0%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $114.0K $93.00K
YoY Change -99.14% -99.24%
% of Gross Profit
Research & Development $6.896M $5.234M
YoY Change -5.64% -20.12%
% of Gross Profit
Depreciation & Amortization $18.00K $11.00K
YoY Change -10.0% -45.0%
% of Gross Profit
Operating Expenses $15.84M $13.19M
YoY Change -23.16% -29.58%
Operating Profit -$15.34M -$13.19M
YoY Change -25.54% -29.5%
Interest Expense
YoY Change
% of Operating Profit
Other Income/Expense, Net $2.824M $2.900M
YoY Change -12.65% -22.71%
Pretax Income -$12.52M -$10.29M
YoY Change -27.94% -31.2%
Income Tax
% Of Pretax Income
Net Earnings -$12.52M -$10.29M
YoY Change -27.94% -31.21%
Net Earnings / Revenue -2503.2%
Basic Earnings Per Share -$0.13 -$0.11
Diluted Earnings Per Share -$0.13 -$0.11
COMMON SHARES
Basic Shares Outstanding 96.90M 96.50M
Diluted Shares Outstanding 96.83M 96.49M

Balance Sheet

Concept 2024 Q2 2024 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $218.7M $223.6M
YoY Change -13.27% -15.45%
Cash & Equivalents $36.63M $56.01M
Short-Term Investments $182.1M $167.6M
Other Short-Term Assets $1.994M $2.609M
YoY Change -28.79% -6.82%
Inventory
Prepaid Expenses
Receivables
Other Receivables $122.0K $280.0K
Total Short-Term Assets $220.7M $226.2M
YoY Change -13.45% -15.38%
LONG-TERM ASSETS
Property, Plant & Equipment $636.0K $616.0K
YoY Change 7.07% 5.48%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $446.0K $528.0K
YoY Change 223.19% -81.79%
Total Long-Term Assets $1.228M $1.342M
YoY Change -66.97% -65.07%
TOTAL ASSETS
Total Short-Term Assets $220.7M $226.2M
Total Long-Term Assets $1.228M $1.342M
Total Assets $222.0M $227.6M
YoY Change -14.22% -16.08%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.272M $839.0K
YoY Change 117.99% -67.48%
Accrued Expenses $2.441M $2.004M
YoY Change -38.98% -49.9%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $6.725M $3.715M
YoY Change -33.11% -62.24%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $0.00
YoY Change -100.0% -100.0%
Total Long-Term Liabilities $0.00 $0.00
YoY Change -100.0% -100.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $6.725M $3.715M
Total Long-Term Liabilities $0.00 $0.00
Total Liabilities $6.725M $3.715M
YoY Change -34.07% -62.99%
SHAREHOLDERS EQUITY
Retained Earnings -$154.1M -$141.6M
YoY Change 41.04% 54.08%
Common Stock $10.00K $10.00K
YoY Change 11.11% 11.11%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $215.2M $223.9M
YoY Change
Total Liabilities & Shareholders Equity $222.0M $227.6M
YoY Change -14.22% -16.08%

Cashflow Statement

Concept 2024 Q2 2024 Q1
OPERATING ACTIVITIES
Net Income -$12.52M -$10.29M
YoY Change -27.94% -31.21%
Depreciation, Depletion And Amortization $18.00K $11.00K
YoY Change -10.0% -45.0%
Cash From Operating Activities -$7.279M -$6.710M
YoY Change -56.33% -46.01%
INVESTING ACTIVITIES
Capital Expenditures $38.00K $83.00K
YoY Change 26.67% -56.99%
Acquisitions
YoY Change
Other Investing Activities -$12.61M -$8.430M
YoY Change -128.02% -92.43%
Cash From Investing Activities -$12.65M -$8.513M
YoY Change -128.12% -92.37%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 545.0K 258.0K
YoY Change -80.88% -80.44%
NET CHANGE
Cash From Operating Activities -7.279M -6.710M
Cash From Investing Activities -12.65M -8.513M
Cash From Financing Activities 545.0K 258.0K
Net Change In Cash -19.38M -14.97M
YoY Change -162.22% -87.8%
FREE CASH FLOW
Cash From Operating Activities -$7.279M -$6.710M
Capital Expenditures $38.00K $83.00K
Free Cash Flow -$7.317M -$6.793M
YoY Change -56.19% -46.18%

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<p id="note1" style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1. Nature of Business</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Description of Business</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">ARS Pharmaceuticals, Inc. (“ARS”, “ARS Pharma” or the “Company”) is focused on the development of ARS-1 (brand name </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">®</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">), a proprietary product candidate for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions including anaphylaxis. The Company incorporated in Delaware in January 2016 and is located in San Diego, California. The Company has a wholly owned subsidiary, ARS Pharmaceuticals Operations, Inc., incorporated in Delaware in August 2015, through which it conducts substantially all its operations. ARS Pharmaceuticals Operations, Inc. has a wholly owned subsidiary in Ireland, ARS Pharmaceuticals IRL, Limited, to facilitate the filing of regulatory approval for </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in European countries.</span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Liquidity and Capital Resources</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net operating losses since its inception and had an accumulated deficit of $</span><span style="font-size:10pt;font-family:Times New Roman;white-space:pre-wrap;min-width:fit-content;color:#000000;">141.6</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million as of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">March 31, 2024. The Company had cash, cash equivalents, and short-term investments of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">223.6</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million as of March 31, 2024 and has not generated positive cash flows from operations. To date, the Company has funded its operations primarily with proceeds from the merger with Silverback in November 2022 (the “Merger”), the issuance of convertible preferred stock, payments earned under collaboration agreements and bank debt. The Company’s currently available cash, cash equivalents, and short-term investments as of March 31, 2024 are sufficient to meet its anticipated cash requirements for at least the 12 months following the date these financial statements are issued.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">From August 5, 2015 (inception) through March 31, 2024, the Company has devoted substantially all of its efforts to developing intellectual property, conducting product development and clinical trials, raising capital, and building infrastructure. The Company has a limited operating history, and the sales and income potential of the Company’s business and market are unproven. If the Company does not successfully commercialize any product candidates for which it receives regulatory approval, it will be unable to generate recurring product revenue or achieve profitability. Management expects operating expenses to increase for the foreseeable future and there can be no assurance that the Company will ever achieve profitability, or if achieved, that it will be sustained on a continuing basis.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company’s ability to raise additional capital may be adversely impacted should the global economic conditions worsen or as a result of further disruptions to, and volatility in, the credit and financial markets in the United States, including bank failures, future health epidemics or pandemics, geopolitical actions or other macroeconomic factors. If such further disruption occurs, the Company could experience an inability to access additional capital. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects.</span></p>
CY2024Q1 us-gaap Use Of Estimates
UseOfEstimates
<p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Use of Estimates</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The preparation of the Company’s condensed consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s condensed consolidated financial statements relate to revenue recognized for its collaboration agreements, accruals for research and development expenses and valuation of equity awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.</span></p>
CY2024Q1 us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Concentrations of Credit Risk</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to cash risk by placing its cash with high credit quality financial institutions.</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company reviews its financial instruments </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">portfolio on a quarterly basis to determine if any unrealized losses have resulted from a credit loss or other factors. As part of the review, management considers factors such as historical experience, market data, issuer-specific factors, and current economic conditions. This review is subjective, as it requires management to evaluate whether an event or change in circumstances has occurred in that period that may be related to credit issues.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
CY2024Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
14473576
CY2023Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
15646849
CY2024Q1 us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodTax
200000
CY2023Q1 us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
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100000
CY2024Q1 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2023Q4 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2024Q1 us-gaap Debt Securities Available For Sale Accrued Interest After Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAccruedInterestAfterAllowanceForCreditLoss
600000
CY2024Q1 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2023Q4 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2024Q1 us-gaap Prepaid Insurance
PrepaidInsurance
688000
CY2023Q4 us-gaap Prepaid Insurance
PrepaidInsurance
904000
CY2024Q1 us-gaap Interest Receivable
InterestReceivable
618000
CY2023Q4 us-gaap Interest Receivable
InterestReceivable
686000
CY2024Q1 spry Prepaid Development Costs
PrepaidDevelopmentCosts
538000
CY2023Q4 spry Prepaid Development Costs
PrepaidDevelopmentCosts
380000
CY2024Q1 us-gaap Prepaid Expense Current And Noncurrent
PrepaidExpenseCurrentAndNoncurrent
465000
CY2023Q4 us-gaap Prepaid Expense Current And Noncurrent
PrepaidExpenseCurrentAndNoncurrent
1124000
CY2024Q1 spry Capitalized Software Implementation Costs
CapitalizedSoftwareImplementationCosts
233000
CY2023Q4 spry Capitalized Software Implementation Costs
CapitalizedSoftwareImplementationCosts
163000
CY2024Q1 us-gaap Other Receivables
OtherReceivables
67000
CY2023Q4 us-gaap Other Receivables
OtherReceivables
109000
CY2024Q1 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
2609000
CY2023Q4 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
3366000
CY2024Q1 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
748000
CY2023Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
695000
CY2024Q1 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
132000
CY2023Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
121000
CY2024Q1 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
616000
CY2023Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
574000
CY2024Q1 us-gaap Capitalized Computer Software Net
CapitalizedComputerSoftwareNet
528000
CY2023Q4 us-gaap Capitalized Computer Software Net
CapitalizedComputerSoftwareNet
617000
CY2024Q1 us-gaap Security Deposit
SecurityDeposit
0
CY2023Q4 us-gaap Security Deposit
SecurityDeposit
21000
CY2024Q1 us-gaap Other Assets
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528000
CY2023Q4 us-gaap Other Assets
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638000
CY2024Q1 spry Accrued Compensation
AccruedCompensation
1066000
CY2023Q4 spry Accrued Compensation
AccruedCompensation
315000
CY2024Q1 us-gaap Accounts Payable Current
AccountsPayableCurrent
839000
CY2023Q4 us-gaap Accounts Payable Current
AccountsPayableCurrent
759000
CY2024Q1 spry Accrued Clinical Expenses
AccruedClinicalExpenses
578000
CY2023Q4 spry Accrued Clinical Expenses
AccruedClinicalExpenses
515000
CY2024Q1 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
509000
CY2023Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
174000
CY2024Q1 spry Accrued Development Expenses
AccruedDevelopmentExpenses
212000
CY2023Q4 spry Accrued Development Expenses
AccruedDevelopmentExpenses
190000
CY2024Q1 spry Accrued Pre Commercialization Marketing Related Expenses Current
AccruedPreCommercializationMarketingRelatedExpensesCurrent
79000
CY2023Q4 spry Accrued Pre Commercialization Marketing Related Expenses Current
AccruedPreCommercializationMarketingRelatedExpensesCurrent
42000
CY2024Q1 us-gaap Taxes Payable Current
TaxesPayableCurrent
47000
CY2023Q4 us-gaap Taxes Payable Current
TaxesPayableCurrent
4000
CY2024Q1 us-gaap Other Accounts Payable And Accrued Liabilities
OtherAccountsPayableAndAccruedLiabilities
168000
CY2023Q4 us-gaap Other Accounts Payable And Accrued Liabilities
OtherAccountsPayableAndAccruedLiabilities
155000
CY2024Q1 us-gaap Accounts Payable And Accrued Liabilities Current And Noncurrent
AccountsPayableAndAccruedLiabilitiesCurrentAndNoncurrent
3498000
CY2023Q4 us-gaap Accounts Payable And Accrued Liabilities Current And Noncurrent
AccountsPayableAndAccruedLiabilitiesCurrentAndNoncurrent
2154000
CY2024Q1 us-gaap Lessee Operating Lease Description
LesseeOperatingLeaseDescription
In October 2021, the Company entered into a 38-month noncancelable lease for its current headquarters location consisting of 4,047 rentable square feet of office space in San Diego, California. Under the terms of the agreement, there is no option to extend the lease, and the Company is subject to additional charges for common area maintenance and other costs
CY2024Q1 us-gaap Lessee Operating Sublease Option To Extend
LesseeOperatingSubleaseOptionToExtend
there is no option to extend the lease
CY2024Q1 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P11M
CY2024Q1 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.08
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
245000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
42000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
287000
CY2024Q1 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
70000
CY2024Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
217000
CY2024Q1 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
217000
CY2024Q1 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
0
CY2024Q1 spry In Licensingandsupply Textblock
InLicensingandsupplyTextblock
<p style="font-size:10pt;margin-top:2pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">7. In-Licensing and Supply</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">License Agreement with Aegis</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In June 2018, the Company entered into a License Agreement (the “Aegis Agreement”) with Aegis Therapeutics, LLC (“Aegis”). Under the Aegis Agreement, the Company licensed the exclusive, worldwide, royalty-bearing, sublicensable, rights to certain proprietary Aegis technology, patent rights and know-how to develop and commercialize epinephrine products. The Company utilizes this technology for the development of its lead product candidate, </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">. As consideration for the license, the Company paid an upfront license fee of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">50,000</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, which was recorded in research and development expenses in the condensed consolidated statement of operations.</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is required to make aggregate milestone payments of up to $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">20.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million upon achievement of certain regulatory and commercial milestones. The regulatory milestone payments under the Aegis Agreement will be recognized as research and development expense upon completion of the required events, as the triggering events are not considered to be probable until they are achieved. The Company made a $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">0.5</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million milestone payment to Aegis upon the achievement of a regulatory milestone during 2019, and a $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">1.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million payment to Aegis upon the FDA’s acceptance of the Company’s NDA submission for </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, which occurred in the third quarter of 2022. The Company may be required to pay royalties based on annual net product sales in the low to mid-single digits on its or its sublicensees’ net sales of the Licensed Products (as defined in the Aegis Agreement) on a country-by-country and product-by-product basis.</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company is responsible for reimbursing Aegis for patent costs incurred in connection with prosecuting and maintaining patent rights that are specific to epinephrine or </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">epinephrine products. There were </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">no</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> expenses recognized in connection with legal patent fees for each of the </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">three months ended March 31, 2024 and 2023.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company may terminate the Aegis Agreement with 30 days writt</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">en notice or either party may terminate the Aegis Agreement for certain breaches of the Aegis Agreement. Unless terminated earlier by either or both parties, the term of the Aegis Agreement will continue until the final expiration of all royalty obligations under the Aegis Agreement.</span></span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In conjunction with the Aegis Agreement, the Company also entered into a Supply Agreement (the “Supply Agreement”) with Aegis that allows the Company to purchase materials for preclinical, development and commercial use at predetermined prices. The Company may elect to have Aegis supply minimum quantities but there are no minimum or maximum purchase obligations under the Supply Agreement unless this election is made. The parties may terminate the Supply Agreement at any time by mutual agreement. In addition, the parties may terminate the Supply Agreement in the event of certain breaches of the Supply Agreement or upon the earlier of the expiration or termination of the Aegis Agreement or June 2028. The Supply Agreement term may be extended by mutual written agreeme</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">nt. Under the Supply Agreement, </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">no</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> expense and $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">0.1</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million in expense was recognized in the </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">three months ended March 31, 2024 and 2023, respectively.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Manufacturing Agreement with Renaissance</span></p><p style="text-indent:24.5pt;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In September 2020, the Company entered into a manufacturing agreement with Renaissance Lakewood, LLC (“Renaissance”), which was subsequently amended in July 2023 (the “Renaissance Agreement”). Pursuant to the Renaissance Agreement, Renaissance agreed to manufacture for, and provide to the Company, </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">neffy </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">nasal unit dose sprays (“Renaissance Products”). The Company is obligated to provide Renaissance with certain supplies to manufacture the Renaissance Products and to purchase from Renaissance a mid double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the E.U., and a high double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the U.S. The Renaissance Agreement contains conventional commercial pharmaceutical manufacturing provisions including certain minimum purchase amounts to be determined in the future based on forecast needs and minimum batch size projections. The Company may also request Renaissance to perform certain services related to the Renaissance Product, for which the Company will pay reasonable compensation to Renaissance.</span></p><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The initial term of the Renaissance Agreement commenced on September 9, 2020 and continues (a) for Renaissance Product designated for commercial sale in the U.S. until the earlier of the fifth anniversary of the (i) target U.S. launch date and (ii) the initial U.S. launch date (“U.S. Initial Term”), and (b) for Renaissance Product designated for commercial sale in the E.U. and other countries, the earlier of the fifth anniversary of (i) the target E.U. launch date and (ii) the initial E.U. launch date (“E.U. Initial Term”), in each case unless earlier terminated by one of the parties. The U.S. Initial Term and E.U. Initial Term automatically renew for successive two-year terms (“Renewal Term”). Either party may elect not to renew the U.S. Renewal Term and/or the E.U. Renewal Term by providing the requisite prior notice to the other party. </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Either party may terminate the Renaissance Agreement (1) for uncured material breach of the other party, (2) upon notice for insolvency-related events of the other party that are not discharged within a defined time period, (3) on a product-by-product basis if the manufacture, distribution or sale would materially contravene any applicable law, (4) by providing the requisite notice if (a) the Company has not submitted a regulatory filing for any Renaissance Product in the U.S. on or before June 30, 2022, (b) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before the target U.S. launch date, (c) the authorization and approval representing more than a targeted number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (d) the Company decided in its sole discretion</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> to cease commercializing the Renaissance Product in the U.S., (5) in the case of a force majeure event that continues for six months or more, or (6) a violation by the other party of trade control or anti-corruption laws.</span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span>
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