$SPRY
ARS Pharmaceuticals, Inc.

2023 Q4 Form 10-Q Financial Statement

#000095017023061996 Filed on November 09, 2023

View on sec.gov

Income Statement

Concept 2023 Q4 2023 Q3 2022 Q4
Revenue $0.00 $0.00 $1.320M
YoY Change -100.0%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $6.822M $14.98M -$3.110M
YoY Change -319.36% 46.06% -140.73%
% of Gross Profit
Research & Development $3.404M $3.002M -$6.170M
YoY Change -155.17% -64.1% -138.88%
% of Gross Profit
Depreciation & Amortization $13.00K $20.00K -$210.0K
YoY Change -106.19% -80.39% -212.3%
% of Gross Profit
Operating Expenses $10.23M $17.98M -$24.58M
YoY Change -141.6% -5.07% -204.56%
Operating Profit -$17.98M
YoY Change -5.07%
Interest Expense -$1.510M
YoY Change -3312.77%
% of Operating Profit
Other Income/Expense, Net $3.058M $3.112M $830.0K
YoY Change 268.43% 6521.28%
Pretax Income -$7.168M -$14.87M $27.24M
YoY Change -126.31% -16.76% -216.11%
Income Tax
% Of Pretax Income
Net Earnings -$7.168M -$14.87M $27.24M
YoY Change -126.31% -16.78% -216.11%
Net Earnings / Revenue 2063.64%
Basic Earnings Per Share -$0.16
Diluted Earnings Per Share -$0.07 -$0.16 $0.50
COMMON SHARES
Basic Shares Outstanding 96.00M 95.57M 36.06M
Diluted Shares Outstanding 95.58M

Balance Sheet

Concept 2023 Q4 2023 Q3 2022 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $228.4M $241.9M $274.4M
YoY Change -16.78% -9.27% 8.01%
Cash & Equivalents $70.97M $60.53M $210.5M
Short-Term Investments $157.4M $181.4M $63.90M
Other Short-Term Assets $3.366M $2.600M $3.300M
YoY Change 2.0% -37.72% -55.69%
Inventory $0.00 $0.00
Prepaid Expenses
Receivables $0.00
Other Receivables $178.0K $208.0K $16.00K
Total Short-Term Assets $231.7M $244.5M $277.7M
YoY Change -16.56% -9.72% 6.2%
LONG-TERM ASSETS
Property, Plant & Equipment $574.0K $617.0K $329.0K
YoY Change 74.47% 4013.33% -85.13%
Goodwill
YoY Change
Intangibles $0.00
YoY Change
Long-Term Investments
YoY Change
Other Assets $638.0K $690.0K
YoY Change 176.0%
Total Long-Term Assets $1.462M $4.090M $3.735M
YoY Change -60.86% 1443.4% -94.81%
TOTAL ASSETS
Total Short-Term Assets $231.7M $244.5M $277.7M
Total Long-Term Assets $1.462M $4.090M $3.735M
Total Assets $233.2M $248.6M $281.4M
YoY Change -17.14% -8.3% -15.6%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $759.0K $2.966M $1.659M
YoY Change -54.25% 2253.97% -20.16%
Accrued Expenses $916.0K $3.500M $1.700M
YoY Change -46.12% -4.08% -85.5%
Deferred Revenue $0.00 $0.00 $283.0K
YoY Change -100.0% -80.58%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00
YoY Change
Total Short-Term Liabilities $2.391M $11.18M $5.444M
YoY Change -56.08% 180.2% -63.44%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $37.00K $100.0K $3.100M
YoY Change -98.81% -34.87%
Total Long-Term Liabilities $37.00K $100.0K $3.100M
YoY Change -98.81% -34.87%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.391M $11.18M $5.444M
Total Long-Term Liabilities $37.00K $100.0K $3.100M
Total Liabilities $2.428M $11.27M $8.549M
YoY Change -71.6% 182.51% -56.5%
SHAREHOLDERS EQUITY
Retained Earnings -$131.3M -$124.1M -$76.94M
YoY Change 70.66% -49.97% -58.68%
Common Stock $10.00K $9.000K $9.000K
YoY Change 11.11% 125.0% 125.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $230.8M $237.3M $272.9M
YoY Change
Total Liabilities & Shareholders Equity $233.2M $248.6M $281.4M
YoY Change -17.14% -8.3% -15.6%

Cashflow Statement

Concept 2023 Q4 2023 Q3 2022 Q4
OPERATING ACTIVITIES
Net Income -$7.168M -$14.87M $27.24M
YoY Change -126.31% -16.78% -216.11%
Depreciation, Depletion And Amortization $13.00K $20.00K -$210.0K
YoY Change -106.19% -80.39% -212.3%
Cash From Operating Activities -$17.41M -$12.76M $11.40M
YoY Change -252.68% -23.04% -153.51%
INVESTING ACTIVITIES
Capital Expenditures -$95.00K $50.00K -$480.0K
YoY Change -80.21% -175.76% -12.73%
Acquisitions
YoY Change
Other Investing Activities $25.95M -$46.60M
YoY Change
Cash From Investing Activities $26.04M -$46.64M $480.0K
YoY Change 5325.0% 70566.67% -101.87%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 1.809M 920.0K 189.4M
YoY Change -99.04% -22.03% 68769.09%
NET CHANGE
Cash From Operating Activities -17.41M -12.76M 11.40M
Cash From Investing Activities 26.04M -46.64M 480.0K
Cash From Financing Activities 1.809M 920.0K 189.4M
Net Change In Cash 10.44M -58.48M 201.3M
YoY Change -94.81% 278.12% -530.85%
FREE CASH FLOW
Cash From Operating Activities -$17.41M -$12.76M $11.40M
Capital Expenditures -$95.00K $50.00K -$480.0K
Free Cash Flow -$17.31M -$12.81M $11.88M
YoY Change -245.72% -22.43% -157.24%

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us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-19581000
us-gaap Payments To Acquire Short Term Investments
PaymentsToAcquireShortTermInvestments
237953000
us-gaap Payments To Acquire Short Term Investments
PaymentsToAcquireShortTermInvestments
0
us-gaap Proceeds From Sale Of Short Term Investments
ProceedsFromSaleOfShortTermInvestments
125000000
us-gaap Proceeds From Sale Of Short Term Investments
ProceedsFromSaleOfShortTermInvestments
0
us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
266000
us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
73000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
-113219000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
-73000
us-gaap Proceeds From Issuance Of Shares Under Incentive And Share Based Compensation Plans Including Stock Options
ProceedsFromIssuanceOfSharesUnderIncentiveAndShareBasedCompensationPlansIncludingStockOptions
5094000
us-gaap Proceeds From Issuance Of Shares Under Incentive And Share Based Compensation Plans Including Stock Options
ProceedsFromIssuanceOfSharesUnderIncentiveAndShareBasedCompensationPlansIncludingStockOptions
287000
spry Financing Activities Cash Paid For Transaction Costs
FinancingActivitiesCashPaidForTransactionCosts
0
spry Financing Activities Cash Paid For Transaction Costs
FinancingActivitiesCashPaidForTransactionCosts
-647000
us-gaap Repayments Of Notes Payable
RepaymentsOfNotesPayable
0
us-gaap Repayments Of Notes Payable
RepaymentsOfNotesPayable
2727000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
5094000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
-3087000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-149986000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-22741000
CY2022Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
210518000
CY2021Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
60063000
CY2023Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
60532000
CY2022Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
37322000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
91000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
0
spry Capital Expenditures Reclassed From Prepaid Expenses And Other Current Assets
CapitalExpendituresReclassedFromPrepaidExpensesAndOtherCurrentAssets
174000
spry Capital Expenditures Reclassed From Prepaid Expenses And Other Current Assets
CapitalExpendituresReclassedFromPrepaidExpensesAndOtherCurrentAssets
0
spry Unpaid Transaction Costs Included In Accounts Payable And Accrued Expenses
UnpaidTransactionCostsIncludedInAccountsPayableAndAccruedExpenses
0
spry Unpaid Transaction Costs Included In Accounts Payable And Accrued Expenses
UnpaidTransactionCostsIncludedInAccountsPayableAndAccruedExpenses
137000
us-gaap Nature Of Operations
NatureOfOperations
<p id="note1" style="text-indent:0;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="text-indent:0;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:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">ARS Pharmaceuticals, Inc. (“ARS” or the “Company”) is focused on the development of ARS-1 (brand name </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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-weight:normal;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-weight:normal;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">in European countries.</span></p><p style="text-indent:0;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;">Merger Transaction</span></p><p style="text-indent:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On November 8, 2022 (the “Closing Date”), Silverback Therapeutics, Inc., a Delaware corporation (“Silverback”), now known as ARS Pharmaceuticals, Inc., completed its reverse merger (the “Merger”) with privately-held ARS Pharmaceuticals, Inc. (“ARS Pharma”), in accordance with the terms of the agreement and plan of merger and reorganization, dated July 21, 2022, as amended on August 11, 2022 and October 25, 2022 (the “Merger Agreement”), whereby Sabre Merger Sub, Inc. (“Merger Sub”), a Delaware corporation and wholly-owned subsidiary of Silverback, merged into ARS Pharma, with ARS Pharma surviving as Silverback’s wholly-owned subsidiary. ARS Pharma was renamed ARS Subsidiary, Inc., and then subsequently renamed ARS Pharmaceuticals Operations, Inc.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">At the effective time of the Merger (the “Effective Time”), each share of ARS Pharma common stock outstanding immediately prior to the Effective Time, after giving effect to the automatic conversion of all shares of preferred stock of ARS Pharma into shares of ARS Pharma common stock immediately prior to the Effective Time (excluding shares held as treasury stock by ARS Pharma or held or owned by Silverback, Merger Sub or any subsidiary of Silverback or ARS Pharma and dissenting shares), was automatically converted into the right to receive shares of Silverback common stock equal to the exchange ratio of </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1.1819</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">. At the completion of the Merger, the prior ARS Pharma equityholders owned </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">62</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">% and the prior Silverback equityholders owned </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">38</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">% of the combined company, in each case on a fully diluted basis using the treasury stock method and excluding out-of-money options of Silverback.</span></p><p style="text-indent:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Merger was accounted for as a reverse recapitalization, with ARS Pharma being treated as the acquirer for accounting purposes. Pursuant to the Merger Agreement, Silverback changed its name to ARS Pharmaceuticals, Inc., and changed its corporate ticker symbol on the Nasdaq Global Market to “SPRY”. See discussions of the transactions in connection with the Merger at </span><a href="#note3"><span style="color:#0000ff;white-space:pre-wrap;font-weight:normal;text-decoration:underline;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Note 3 - Merger and Related Transactions</span></a><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0;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;">Reduction in Force</span></p><p style="text-indent:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On September 19, 2023, the FDA issued a CRL regarding our NDA for </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">. On September 29, 2023, we initiated a </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">20</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">% reduction in force (“RIF”) in order to conserve our cash resources and manage operating expenses until the anticipated PDUFA target action date in the second half of 2024. We provided severance payments, continuation of group health insurance coverage, and other benefits for a specified period to the affected employees. We will incur costs of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">0.6</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million for termination benefits resulting from the RIF.</span></p><p style="text-indent:0;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:4.533%;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:normal;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 $</span><span style="font-size:10pt;font-family:Times New Roman;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">124.1</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million as of </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">September 30, 2023. The Company had cash, cash equivalents, and short-term investments of </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">241.9</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">September 30, 2023 and has not generated positive cash flows from operations. To date, the Company has funded its operations primarily with proceeds from 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 September 30, 2023 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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">From August 5, 2015 (inception) through September 30, 2023, 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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;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:normal;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>
CY2023Q3 us-gaap Restructuring And Related Cost Number Of Positions Eliminated Period Percent
RestructuringAndRelatedCostNumberOfPositionsEliminatedPeriodPercent
0.20
CY2023Q3 us-gaap Severance Costs1
SeveranceCosts1
600000
spry Stockholdersequitynotestocksplitexchangeratio
Stockholdersequitynotestocksplitexchangeratio
1.1819
us-gaap Use Of Estimates
UseOfEstimates
<p style="text-indent:0;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:4.533%;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:normal;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>
CY2022Q4 us-gaap Other Assets Noncurrent
OtherAssetsNoncurrent
0
us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="text-indent:0;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:4.533%;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:normal;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:4.533%;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:normal;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-weight:normal;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
spry Stockholdersequitynotestocksplitexchangeratio
Stockholdersequitynotestocksplitexchangeratio
1.1819
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
14952341
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
32154255
CY2023Q3 us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodTax
600000
us-gaap Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodTax
600000
CY2023Q3 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2022Q4 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2023Q3 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2022Q4 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
CY2023Q3 us-gaap Other Assets
OtherAssets
3173000
CY2023Q3 us-gaap Prepaid Expense Current And Noncurrent
PrepaidExpenseCurrentAndNoncurrent
1034000
CY2022Q4 us-gaap Prepaid Expense Current And Noncurrent
PrepaidExpenseCurrentAndNoncurrent
771000
CY2023Q3 us-gaap Prepaid Insurance
PrepaidInsurance
716000
CY2022Q4 us-gaap Prepaid Insurance
PrepaidInsurance
1539000
CY2023Q3 us-gaap Interest Receivable
InterestReceivable
691000
CY2022Q4 us-gaap Interest Receivable
InterestReceivable
796000
CY2023Q3 us-gaap Other Receivables
OtherReceivables
123000
CY2022Q4 us-gaap Other Receivables
OtherReceivables
213000
CY2023Q3 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
2564000
CY2022Q4 us-gaap Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
3319000
CY2023Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
726000
CY2022Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
377000
CY2023Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
109000
CY2022Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
48000
CY2023Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
617000
CY2022Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
329000
CY2023Q3 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
CY2023Q3 us-gaap Prepaid Expense Other Noncurrent
PrepaidExpenseOtherNoncurrent
2483000
CY2022Q4 us-gaap Prepaid Expense Other Noncurrent
PrepaidExpenseOtherNoncurrent
2940000
CY2023Q3 us-gaap Security Deposit
SecurityDeposit
0
CY2022Q4 us-gaap Security Deposit
SecurityDeposit
21000
CY2023Q3 us-gaap Other Assets Noncurrent
OtherAssetsNoncurrent
690000
CY2022Q4 us-gaap Other Assets
OtherAssets
2961000
CY2023Q3 us-gaap Accounts Payable Current
AccountsPayableCurrent
2966000
CY2022Q4 us-gaap Accounts Payable Current
AccountsPayableCurrent
1659000
CY2023Q3 spry Accrued Pre Commercialization Marketing Related Expenses Current
AccruedPreCommercializationMarketingRelatedExpensesCurrent
2622000
CY2022Q4 spry Accrued Pre Commercialization Marketing Related Expenses Current
AccruedPreCommercializationMarketingRelatedExpensesCurrent
0
CY2023Q3 spry Accrued Compensation
AccruedCompensation
2151000
CY2022Q4 spry Accrued Compensation
AccruedCompensation
447000
CY2023Q3 spry Accrued Development Expenses
AccruedDevelopmentExpenses
654000
CY2022Q4 spry Accrued Development Expenses
AccruedDevelopmentExpenses
133000
CY2023Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
455000
CY2022Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
908000
CY2023Q3 spry Accrued Clinical Expenses
AccruedClinicalExpenses
944000
CY2022Q4 spry Accrued Clinical Expenses
AccruedClinicalExpenses
609000
CY2023Q3 us-gaap Taxes Payable Current
TaxesPayableCurrent
0
CY2022Q4 us-gaap Taxes Payable Current
TaxesPayableCurrent
174000
CY2023Q3 us-gaap Other Accounts Payable And Accrued Liabilities
OtherAccountsPayableAndAccruedLiabilities
1153000
CY2022Q4 us-gaap Other Accounts Payable And Accrued Liabilities
OtherAccountsPayableAndAccruedLiabilities
1001000
CY2023Q3 us-gaap Accounts Payable And Accrued Liabilities Current And Noncurrent
AccountsPayableAndAccruedLiabilitiesCurrentAndNoncurrent
10945000
CY2022Q4 us-gaap Accounts Payable And Accrued Liabilities Current And Noncurrent
AccountsPayableAndAccruedLiabilitiesCurrentAndNoncurrent
4931000
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us-gaap Lessee Operating Lease Description
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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
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spry In Licensingandsupply Textblock
InLicensingandsupplyTextblock
<p style="text-indent:0;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;">8. 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="text-indent:0;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:4.533%;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:normal;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-weight:normal;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-weight:normal;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;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">50,000</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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:4.533%;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:normal;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;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">20.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">0.5</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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-weight:normal;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-weight:normal;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:4.533%;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:normal;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 epinephrine products. There were </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">no</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> expenses recognized in connection with legal patent fees for the </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">nine months ended September 30, 2023 and 2022.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company may terminate the Aegis Agreement with 30 days written 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:4.533%;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:normal;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 agreement. Under the Supply Agreement, </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">no</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">0.3</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">three and nine months ended September 30, 2023, respectively.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;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;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">No</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> expense was recognized in each of the </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">three and nine months ended September 30, 2022.</span></p><p style="text-indent:0;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:4.533%;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:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In September 2020, the Company entered into a manufacturing agreement (the “Renaissance Agreement”) with Renaissance Lakewood, LLC (“Renaissance”). 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-weight:normal;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-weight:normal;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><p style="text-indent:4.533%;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:normal;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-weight:normal;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-weight:normal;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="font-size:10pt;font-family:Times New Roman;"></span></p>
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