What changed in TALPHERA, INC.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of TALPHERA, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+282 added−302 removedSource: 10-K (2026-03-23) vs 10-K (2025-03-31)
Top changes in TALPHERA, INC.'s 2025 10-K
282 paragraphs added · 302 removed · 221 edited across 1 sections
- Item 6. [Reserved]+282 / −302 · 221 edited
Item 6. [Reserved]
Selected Financial Data — reserved (removed by SEC in 2021)
221 edited+61 added−81 removed211 unchanged
Item 6. [Reserved]
Selected Financial Data — reserved (removed by SEC in 2021)
221 edited+61 added−81 removed211 unchanged
2024 filing
2025 filing
Biggest changeConsolidated Statements of Cash Flows (in thousands) Year Ended December 31, 2024 2023 Cash flows from operating activities: Net loss $ (13,004 ) $ (18,397 ) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash interest expense on liability related to the sale of future payments 394 — Depreciation and amortization — 311 Net amortization of discount on short-term investments (121 ) (24 ) Non-cash interest expense related to debt financing — 53 Revaluation of liability for Lowell holdback shares — (723 ) Stock-based compensation 989 1,729 Gain on change in fair value of warrant liability (717 ) (5,320 ) Impairment of net assets held for sale — 6,853 Impairment of fixed assets — 1,065 Gain on termination of lease liabilities — (1,098 ) Gain on extinguishment of debt liability — (400 ) Changes in operating assets and liabilities: Inventories — 61 Prepaid expenses and other current assets 1,641 281 Accounts payable (671 ) (575 ) Accrued liabilities (1,194 ) (1,132 ) Operating lease liabilities — (147 ) Deferred revenue — (29 ) Net cash used in operating activities (12,683 ) (17,492 ) Cash flows from investing activities: Purchase of property and equipment — (100 ) Sale of the DSUVIA assets — 2,723 Purchase of investments (4,979 ) (3,651 ) Proceeds from maturities of investments 8,760 500 Net cash provided by (used in) investing activities 3,781 (528 ) Cash flows from financing activities: Payment of long-term debt — (5,416 ) Gross proceeds from sale of future payments 6,654 — Issuance costs related to sale of future payments (521 ) — Net proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in July 2023 private placement offering — 8,856 Net proceeds from issuance of common stock in connection with exercise of pre-funded warrants — 3 Net proceeds from issuance of pre-funded warrants in January 2024 private placement offering 5,884 — Net proceeds from issuance of common stock through equity plans 27 23 Net cash provided by financing activities 12,044 3,466 Net change in cash and cash equivalents 3,142 (14,554 ) Cash and cash equivalents—Beginning of period 5,721 20,275 Cash and cash equivalents—End of period $ 8,863 $ 5,721 Supplemental Disclosures of Cash Flow Information: Cash paid for interest $ — $ 119 Income taxes paid $ — $ — Noncash Investing and Financing Activities: Equity issuance costs from warrant modification $ 251 $ — Settlement of held back shares issued in connection with asset acquisition $ — $ (77 ) Offering costs in accounts payable $ — $ 72 Fair value of warrants issued to placement agent $ — $ 263 See notes to consolidated financial statements.
Biggest changeConsolidated Statements of Cash Flows (in thousands) Year Ended December 31, 2025 2024 Cash flows from operating activities: Net loss $ (14,290 ) $ (13,004 ) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash revenue related to the sale of future payments (28 ) — Non-cash interest expense on the liability related to the sale of future payments — 394 Net amortization of discount on short-term investments (142 ) (121 ) Stock-based compensation 699 989 Revaluation of warrant liability 1,315 (717 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets 35 1,641 Accounts payable (208 ) (671 ) Accrued liabilities 1,255 (1,194 ) Net cash used in operating activities (11,364 ) (12,683 ) Cash flows from investing activities: Purchase of investments (17,815 ) (4,979 ) Proceeds from sale of investments 10 — Proceeds from maturities of investments 3,460 8,760 Net cash (used in) provided by investing activities (14,345 ) 3,781 Cash flows from financing activities: Gross proceeds from the sale of future payments — 6,654 Issuance costs related to the sale of future payments — (521 ) Net proceeds from the issuance of common stock and pre-funded warrants in connections with private placement offerings 22,723 5,884 Net proceeds from issuance of common stock through equity plans 17 27 Net cash provided by financing activities 22,740 12,044 Net change in cash and cash equivalents (2,969 ) 3,142 Cash and cash equivalents—Beginning of period 8,863 5,721 Cash and cash equivalents—End of period $ 5,894 $ 8,863 Noncash Investing and Financing Activities: Equity issuance costs from warrant modification $ — $ 251 Offering costs in accounts payable and accrued liabilities $ 116 $ — See notes to consolidated financial statements.
Net Income (Loss) per Share of Common Stock Basic and diluted net income (loss) per common share, or EPS, are calculated in accordance with the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 260 , Earnings per Share .
Net Loss per Share of Common Stock Basic and diluted net income (loss) per common share, or EPS, are calculated in accordance with the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 260, Earnings per Share .
Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values.
Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values.
Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values.
Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values.
When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project.
When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project.
Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
In-Process Research and Development In accordance with ASC Topic 350, Intangibles - Goodwill and Other , the acquired IPR&D has initially been accounted for as an indefinite-lived intangible asset and, therefore, not amortized.
In-Process Research and Development In accordance with ASC Topic 350, Intangibles - Goodwill and Other , the acquired IPR&D has initially been accounted for as an indefinite-lived intangible asset and, therefore, not amortized.
If the IPR&D asset achieves regulatory approval and the asset life is determined to be finite, the asset’s useful life will be estimated, and the asset will be amortized over its remaining useful life.
If the IPR&D asset achieves regulatory approval and the asset life is determined to be finite, the asset’s useful life will be estimated, and the asset will be amortized over its remaining useful life.
The IPR&D asset is reviewed for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.
The IPR&D asset is reviewed for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.
Discontinued Operations In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations , a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results.
Discontinued Operations In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations , a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results.
In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations.
In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations.
Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability classified warrants are measured at fair value on the issuance date and at the end of each reporting period.
Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability classified warrants are measured at fair value on the issuance date and at the end of each reporting period.
Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations.
Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations.
Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration and are exercisable after the original issuance date.
Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration and are exercisable after the original issuance date.
District Court for the Northern District of California. The complaint names ten of the Company’s officers and directors and asserts state and federal claims based on the same alleged misstatements as the securities class action complaint. On September 30, 2021, October 26, 2021, and November 17, 2021, three additional purported shareholder derivative complaints were filed in the U.S.
The complaint names ten of the Company’s officers and directors and asserts state and federal claims based on the same alleged misstatements as the securities class action complaint. On September 30, 2021, October 26, 2021, and November 17, 2021, three additional purported shareholder derivative complaints were filed in the U.S. District Court for the Northern District of California.
In-License Agreement On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe for injection, and (ii) a phenylephrine pre-filled syringe for injection.
In-License Agreement On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe for injection (Fedsyra), and (ii) a phenylephrine pre-filled syringe for injection.
Our participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the Series A and Series B common stock warrants, the placement agent Series A and Series B common stock warrants (see Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information).
Our participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the Series A and Series B common stock warrants, the placement agent Series A and Series B common stock warrants (see Note 8, “Stockholders’ Equity” and Note 9, “Warrants” to our consolidated financial statements in this Annual Report on Form 10-K for additional information).
Recently Issued Accounting Pronouncements In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses , which is intended to enhance transparency into the nature and function of expenses, primarily through additional disclosures on certain cost and expenses.
Recently Issued Accounting Pronouncements In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses , or ASU 2024-03, which is intended to enhance transparency into the nature and function of expenses, primarily through additional disclosures on certain cost and expenses.
Financial Statements: See Index to Financial Statements in Item 8 of this Form 10-K. 61 2. Financial Statement Schedules: Reference is made to the financial statement schedules included under Item 8 of Part II hereof. All other schedules are omitted because they are not applicable, not required or the information is shown in the financial statements or the notes thereto.
Financial Statements: See Index to Financial Statements in Item 8 of this Form 10-K. 2. Financial Statement Schedules: Reference is made to the financial statement schedules included under Item 8 of Part II hereof. All other schedules are omitted because they are not applicable, not required or the information is shown in the financial statements or the notes thereto.
Sale of Future Payments On January 12, 2024, the Company entered into the Purchase Agreement with XOMA to monetize a portion of its future payments for commercial sales of DSUVIA and services performed by the Company to support sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement, and sales milestones under the DSUVIA Agreement.
F-12 Sale of Future Payments On January 12, 2024, the Company entered into the Purchase Agreement with XOMA to monetize a portion of its future payments for commercial sales of DSUVIA and services performed by the Company to support sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement, and sales milestones under the DSUVIA Agreement.
Critical Audit Matters Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
F-2 Critical Audit Matters Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
The rights, preferences and privileges of the holders of Common Stock are subject to and may be adversely affected by the rights of the holders of shares of any series of Preferred Stock that we may designate in the future. As of December 31, 2024, there are no shares of Preferred Stock issued and outstanding.
The rights, preferences and privileges of the holders of Common Stock are subject to and may be adversely affected by the rights of the holders of shares of any series of Preferred Stock that we may designate in the future. As of December 31, 2025 and 2024, there are no shares of Preferred Stock issued and outstanding.
F-29 Upon the closing of the December 2022 Financing, 750,000 of the 875,000 November 2021 Financing Warrants were modified, to reduce the exercise price of the warrants from $20.00 per share to $2.07 per share and to extend the expiration date to December 29, 2028.
Upon the closing of the December 2022 Financing, 750,000 of the 875,000 November 2021 Financing Warrants were modified, to reduce the exercise price of the warrants from $20.00 per share to $2.07 per share and to extend the expiration date to December 29, 2028.
The terms of the January 2024 Private Placement include: (i) the first tranche of the January 2024 Private Placement, which closed on January 22, 2024, resulted in the aggregate gross proceeds to the Company of approximately $6.0 million for pre-funded warrants to purchase up to 7,792,208 shares of Common Stock, excluding the proceeds, if any, from the exercise of the pre-funded warrants issued in such tranche, or the January 2024 Pre-Funded Warrants (see Note 10, “Warrants”).
The terms of the January 2024 Private Placement include: (i) the first tranche of the January 2024 Private Placement, which closed on January 22, 2024, resulted in the aggregate gross proceeds to the Company of approximately $6.0 million for pre-funded warrants to purchase up to 7,792,208 shares of Common Stock, excluding the proceeds, if any, from the exercise of the pre-funded warrants issued in such tranche, or the January 2024 Pre-Funded Warrants (see Note 9, “Warrants”).
The remaining warrants issued in the November 17, 2021, registered direct offering for 125,000 shares of the Company’s common stock are currently exercisable at a price of $20.00 per share and expire on November 15, 2026. As of December 31, 2024, none the November 2021 Financing Warrants had been exercised and all remained outstanding.
The remaining warrants issued in the November 17, 2021, registered direct offering for 125,000 shares of the Company’s common stock are currently exercisable at a price of $20.00 per share and expire on November 15, 2026. As of December 31, 2025, none of the November 2021 Financing Warrants had been exercised and all remained outstanding.
F-6 Talphera, Inc. Notes to Consolidated Financial Statements (In thousands, except where otherwise noted) 1. Organization and Summary of Significant Accounting Policies The Company Talphera, Inc., or the Company, or Talphera, was incorporated in Delaware on July 13, 2005, as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. and, on January 9, 2024, to Talphera, Inc.
F-7 Talphera, Inc. Notes to Consolidated Financial Statements (In thousands, except where otherwise noted) 1. Organization and Summary of Significant Accounting Policies The Company Talphera, Inc., or the Company, or Talphera, was incorporated in Delaware on July 13, 2005, as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. and, on January 9, 2024, to Talphera, Inc.
The placement agent July 2023 Series A and Series B Common Stock Warrants (see Note 9, “Stockholders’ Equity”) have the same terms as the July 2023 Series A and Series B Common Stock Warrants, except such warrants do not have a Black Scholes provision in the event of a fundamental transaction and the exercise price of such warrants is $1.70 per share, which is 125% of the combined offering price per share.
The placement agent July 2023 Series A and Series B Common Stock Warrants (see Note 8, “Stockholders’ Equity”) have the same terms as the July 2023 Series A and Series B Common Stock Warrants, except such warrants do not have a Black Scholes provision in the event of a fundamental transaction and the exercise price of such warrants is $1.70 per share, which is 125% of the combined offering price per share.
On April 25, 2023, the December 2022 Common Stock Warrants were amended to remove these full ratchet anti-dilutive adjustment rights. F-28 In the event of certain fundamental transactions involving the Company, the holder of the December 2022 Common Stock Warrants may require the Company to make a payment based on a Black-Scholes valuation, using specified inputs.
On April 25, 2023, the December 2022 Common Stock Warrants were amended to remove these full ratchet anti-dilutive adjustment rights. In the event of certain fundamental transactions involving the Company, the holder of the December 2022 Common Stock Warrants may require the Company to make a payment based on a Black-Scholes valuation, using specified inputs.
We believe the following policies to be the most critical to an understanding of our financial condition and results of operations because they require us to make estimates, assumptions and judgments about matters that are inherently uncertain. Management has discussed the development, selection and disclosure of the following estimates with the Audit Committee.
We believe the following policies to be the most critical to an understanding of our financial condition and results of operations because they require us to make estimates, assumptions and judgments about matters that are inherently uncertain. Management has discussed the development, selection and disclosure of the following significant accounting estimates with the Audit Committee.
On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Laboratoire Aguettant, or Aguettant, pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States an ephedrine pre-filled syringe for injection, and (ii) a phenylephrine PFS for injection.
On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Laboratoire Aguettant, or Aguettant, pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe for injection (Fedsyra), and (ii) a phenylephrine PFS for injection.
F-7 Management may seek to raise such additional capital through public or private equity offerings, debt securities, a new debt facility, monetizing or securitizing certain assets, entering into product development, license or distribution agreements with third parties, or divesting any of the Company’s remaining product candidates.
F-8 Management may seek to raise such additional capital through public or private equity offerings, debt securities, a new debt facility, monetizing or securitizing certain assets, entering into product development, license or distribution agreements with third parties, or divesting any of the Company’s remaining product candidates.
In connection with the January 2024 Private Placement, the Company and the January 2024 Purchasers agreed to amend and restate a portion of the July 2023 Series A common stock warrants and July 2023 Series B common stock warrants outstanding by reducing the exercise price thereunder from $1.11 to $0.77 per share (see Note 10, “Warrants”).
In connection with the January 2024 Private Placement, the Company and the January 2024 Purchasers agreed to amend and restate a portion of the July 2023 Series A common stock warrants and July 2023 Series B common stock warrants outstanding by reducing the exercise price thereunder from $1.11 to $0.77 per share (see Note 9, “Warrants”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
F-11 Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company ’ s Own Stock .
Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company ’ s Own Stock .
Our future capital requirements may vary materially from our expectations based on numerous factors, including, but not limited to, the following: • the ability to timely and successfully complete our clinical trial for the Niyad product candidate; • the outcome, timing and cost of the development of our other nafamostat product candidates; • expenditures related to drafting and submission of new drug or device regulatory applications with the FDA for our developmental product candidates and payment of statutory filing fees and related application prosecution costs arising from such submissions; • costs associated with business development activities and licensing transactions; • the outcome and timing of the regulatory submissions for our product candidates and any approvals for our product candidates; 58 • expenditures related to the potential commercialization of our product candidates, if approved; • the initiation, progress, timing and completion of any post-approval clinical trials for our product candidates, if approved; • the ability to retain the listing of our common stock on Nasdaq; • changes in the focus and direction of our business strategy and/or research and development programs; • delays that may be caused by changing regulatory requirements; • the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; • the timing and terms of future in-licensing and out-licensing transactions; • the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities; • the potential impact of trade laws and regulations of the United States associated with the use of our contract development and manufacturing organization, or CDMO, for nafamostat-based finished goods located in China; • the cost of procuring clinical supplies of our product candidates, and commercial supplies, if approved; • the cost of establishing new supply chains and related third party logistics to support our developmental product candidates; • the extent to which we acquire or invest in businesses, products and product candidates or technologies; and • the expenses associated with litigation.
Our future capital requirements may vary materially from our expectations based on numerous factors, including, but not limited to, the following: • the ability to timely and successfully complete our clinical trial for the Niyad product candidate; 54 • the outcome, timing and cost of the development of our other nafamostat product candidates; • expenditures related to drafting and submission of new drug or device regulatory applications with the FDA for our developmental product candidates and payment of statutory filing fees and related application prosecution costs arising from such submissions; • costs associated with business development activities and licensing transactions; • the outcome and timing of the regulatory submissions for our product candidates and any approvals for our product candidates; • expenditures related to the potential commercialization of our product candidates, if approved; • the initiation, progress, timing and completion of any post-approval clinical trials for our product candidates, if approved; • changes in the focus and direction of our business strategy and/or research and development programs; • delays that may be caused by changing regulatory requirements; • the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; • the timing and terms of future in-licensing and out-licensing transactions; • the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities; • the potential impact of trade laws and regulations of the United States associated with the use of our contract development and manufacturing organization, or CDMO, for nafamostat-based finished goods located in China; • the cost of procuring clinical supplies of our product candidates, and commercial supplies, if approved; • the cost of establishing new supply chains and related third party logistics to support our developmental product candidates; • the extent to which we acquire or invest in businesses, products and product candidates or technologies; and • the expenses associated with litigation.
Management has assessed the effectiveness of Talphera’s internal control over financial reporting as of December 31, 2024, and has concluded that such internal control over financial reporting was effective. This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Management has assessed the effectiveness of Talphera’s internal control over financial reporting as of December 31, 2025, and has concluded that such internal control over financial reporting was effective. This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Common Stock January 2024 Private Placement On January 17, 2024, the Company entered into a private placement with certain institutional investors, or the January 2024 Purchasers, for aggregate gross proceeds of $6.0 million upfront, an additional $10.0 million committed upon the announcement of positive clinical trial results for the Company’s NEPHRO CRRT study of Niyad, and an additional $2.0 million if Talphera stock trades above a specified price following the NEPHRO CRRT registration trial announcement, before deducting offering expenses payable by the Company, or the January 2024 Private Placement.
F-23 January 2024 Private Placement On January 17, 2024, the Company entered into a private placement with certain institutional investors, or the January 2024 Purchasers, for aggregate gross proceeds of $6.0 million upfront, an additional $10.0 million committed upon the announcement of positive clinical trial results for the Company’s NEPHRO CRRT study of Niyad, and an additional $2.0 million if Talphera stock trades above a specified price following the NEPHRO CRRT registration trial announcement, before deducting offering expenses payable by the Company, or the January 2024 Private Placement.
Item 6. Reserved 48 Item 7. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis should be read in conjunction with our audited financial statements and the related notes that appear elsewhere in this Annual Report on Form 10-K.
Item 6. Reserved 46 Item 7. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis should be read in conjunction with our audited financial statements and the related notes that appear elsewhere in this Annual Report on Form 10-K.
Changes in Internal Control over Financial Reporting There has been no change in our internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) that occurred during the quarter ended December 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Changes in Internal Control over Financial Reporting There has been no change in our internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) that occurred during the quarter ended December 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition.
In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. F-10 For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition.
F-23 On September 30, 2024, the Company amended the securities purchase agreements of the January 2024 Private Placement, dated January 17, 2024, with entities affiliated with Nantahala Management, LLC, or the Nantahala Agreements, to extend to June 30, 2025 the date by which the Company must achieve the precedent conditions to the second closing thereunder, or the Nantahala Amendments.
On September 30, 2024, the Company amended the securities purchase agreements of the January 2024 Private Placement, dated January 17, 2024, with entities affiliated with Nantahala Management, LLC, or the Nantahala Agreements, to extend to June 30, 2025 the date by which the Company must achieve the precedent conditions to the second closing thereunder, or the Nantahala Amendments.
F-25 Inducement Grant In May 2024, the Company granted stock-based awards outside of the existing stock plans to one new employee, or the Inducement Grant. These awards were granted as a material inducement for accepting employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4).
Inducement Grant In May 2024, the Company granted stock-based awards outside of the existing stock plans to one new employee, or the Inducement Grant. These awards were granted as a material inducement for accepting employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4).
F-27 The July 2023 Series A and Series B common stock warrants were exercisable immediately following the closing date of July 20, 2023, and have a five -year term, unless certain milestone events are met which accelerate the expiration date to 45 days following such announcement.
The July 2023 Series A and Series B common stock warrants were exercisable immediately following the closing date of July 20, 2023, and have a five -year term, unless certain milestone events are met which accelerate the expiration date to 45 days following such announcement.
There were no accrued interest or penalties related to unrecognized tax benefits in the years ended December 31, 2024 or 2023. The Company files income tax returns in the United States, California, and other states. The tax years 2005 through 2014, and 2016 through 2024, remain open in all jurisdictions.
There were no accrued interest or penalties related to unrecognized tax benefits in the years ended December 31, 2025 or 2024. The Company files income tax returns in the United States, California, and other states. The tax years 2005 through 2014, and 2016 through 2025, remain open in all jurisdictions.
Liquidity and Going Concern The consolidated financial statements for the year ended December 31, 2024, were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business.
Liquidity and Going Concern The consolidated financial statements for the year ended December 31, 2025, were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business.
Critical Accounting Estimates The accompanying discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements and the related disclosures, which have been prepared in accordance with accounting principles generally accepted in the United States.
Critical Accounting Policies and Significant Accounting Estimates The accompanying discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements and the related disclosures, which have been prepared in accordance with accounting principles generally accepted in the United States.
At the same time, the results of all discontinued operations, less applicable income taxes, shall be reported as components of net loss separate from the net income (loss) of continuing operations. The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023.
At the same time, the results of all discontinued operations, less applicable income taxes, shall be reported as components of net loss separate from the net income (loss) of continuing operations. F-11 The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information contained in the sections captioned “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” of the 2025 Proxy Statement is incorporated herein by reference. Item 13.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information contained in the sections captioned “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” of the 2026 Proxy Statement is incorporated herein by reference. Item 13.
Angotti Chief Executive Officer and Director (Principal Executive Officer) /s/ Raffi Asadorian Raffi Asadorian Chief Financial Officer (Principal Financial and Accounting Officer) 66 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Vincent J.
Angotti Chief Executive Officer and Director (Principal Executive Officer) /s/ Raffi Asadorian Raffi Asadorian Chief Financial Officer (Principal Financial and Accounting Officer) 61 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Vincent J.
As of June 16, 2020, no more awards may be granted under the 2011 Equity Incentive Plan, or the 2011 EIP, although all outstanding stock options and other stock awards previously granted under the 2011 EIP will continue to remain subject to the terms of the 2011 EIP.
As of June 16, 2020, no additional awards may be granted under the 2011 Equity Incentive Plan, or the 2011 EIP, although all outstanding stock options and other stock awards previously granted under the 2011 EIP will continue to remain subject to the terms of the 2011 EIP.
The following discussion and analysis covers our financial condition and results of operations for the year ended December 31, 2024, including year-over-year comparisons versus the year ended December 31, 2023, as reported in our Annual Report on Form 10-K for the year ended December 31, 2023.
The following discussion and analysis covers our financial condition and results of operations for the year ended December 31, 2025, including year-over-year comparisons versus the year ended December 31, 2024, as reported in our Annual Report on Form 10-K for the year ended December 31, 2024.
Information regarding the procedures by which our shareholders may recommend nominees to our Board of Directors set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Nominating and Corporate Governance Committee” of the 2025 Proxy Statement is incorporated herein by reference.
Information regarding the procedures by which our shareholders may recommend nominees to our Board of Directors set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Nominating and Corporate Governance Committee” of the 2026 Proxy Statement is incorporated herein by reference.
(the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).
(the “Company”) as of December 31, 2025 and 2024, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
December 2022 Registered Direct Offering Warrants On December 29, 2022, the Company issued pre-funded warrants to purchase 2,632,898 shares of Common Stock, or the December 2022 Pre-Funded Warrants, and common warrants to purchase an aggregate of 4,227,052 shares of Common Stock, or the December 2022 Common Stock Warrants.
F-28 December 2022 Registered Direct Offering Warrants On December 29, 2022, the Company issued pre-funded warrants to purchase 2,632,898 shares of Common Stock, or the December 2022 Pre-Funded Warrants, and common warrants to purchase an aggregate of 4,227,052 shares of Common Stock, or the December 2022 Common Stock Warrants.
Specifically, critical accounting estimates have the following attributes: (i) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and (ii) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Significant accounting estimates have the following attributes: (i) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and (ii) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
F-8 Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks.
Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks.
Information regarding our Audit Committee, including the members of our Audit Committee, set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Audit Committee” of the 2025 Proxy Statement is incorporated herein by reference.
Information regarding our Audit Committee, including the members of our Audit Committee, set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Audit Committee” of the 2026 Proxy Statement is incorporated herein by reference.
Information regarding our Code of Business Conduct and Ethics set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Code of Business Conduct and Ethics” of the 2025 Proxy Statement is incorporated herein by reference.
Information regarding our Code of Business Conduct and Ethics set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Code of Business Conduct and Ethics” of the 2026 Proxy Statement is incorporated herein by reference.
The Company’s participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the July 2023 Series A and Series B common stock warrants, and the placement agent July 2023 Series A and Series B common stock warrants (see Note 9, “Stockholders’ Equity” and Note 10, “Warrants”).
The Company’s participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the July 2023 Series A and Series B common stock warrants, and the placement agent July 2023 Series A and Series B common stock warrants (see Note 8, “Stockholders’ Equity” and Note 9, “Warrants”).
In order to determine the amortization of the liability related to the sale of future payments, we are required to estimate the total amount of future payments to XOMA over the life of the Purchase Agreement. As mentioned above, in October 2024, Alora notified us that they are discontinuing their DSUVIA sales efforts to non-DoD customers.
In order to determine the amortization of the liability related to the sale of future payments, we are required to estimate the total amount of future payments to XOMA over the life of the Purchase Agreement. As mentioned above, in October 2024, Alora notified us that they had discontinued their DSUVIA sales efforts to non-DoD customers.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2024.
Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2025.
Gain on sale of future payments for 2024 consisted of $1.2 million in other income related to the XOMA Purchase Agreement (see Note 7, “Sale of Future Payments” to the consolidated financial statements in this Annual Report on Form 10-K for additional information).
Gain on sale of future payments for 2024 consisted of $1.2 million in other income related to the XOMA Purchase Agreement (see Note 6, “Sale of Future Payments” to our consolidated financial statements in this Annual Report on Form 10-K for additional information).
F-17 The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023. Accordingly, the liabilities associated with these operations have been classified as liabilities of discontinued operations in the consolidated balance sheets at December 31, 2024 and 2023. There were no assets of discontinued operations at December 31, 2024 or 2023.
The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023. Accordingly, the liabilities associated with these operations have been classified as liabilities of discontinued operations in the consolidated balance sheets at December 31, 2025 and 2024. There were no assets of discontinued operations at December 31, 2025 or 2024.
Principal Accounting Fees and Services Information regarding our independent auditor fees and services in the section captioned “Proposal No. 2—Ratification of Selection of Independent Registered Public Accounting Firm” of the 2025 Proxy Statement is incorporated herein by reference. PART IV Item 15. Exhibits and Financial Statement Schedules (a) The following documents are filed as part of this Form 10-K: 1.
Principal Accounting Fees and Services Information regarding our independent auditor fees and services in the section captioned “Proposal No. 2—Ratification of Appointment of Independent Registered Public Accounting Firm” of the 2026 Proxy Statement is incorporated herein by reference. PART IV Item 15. Exhibits and Financial Statement Schedules (a) The following documents are filed as part of this Form 10-K: 1.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID Number 207) F-2 Consolidated Balance Sheets at December 31, 2024 and 2023 F-3 Consolidated Statements of Operations for the years ended December 31, 2024 and 2023 F-4 Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024 and 2023 F-5 Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023 F-6 Notes to Consolidated Financial Statements F-7 F-1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Shareholders and Board of Directors of Talphera, Inc.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID Number 207) F-2 Consolidated Balance Sheets at December 31, 2025 and 2024 F-4 Consolidated Statements of Operations for the years ended December 31, 2025 and 2024 F-5 Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2025 and 2024 F-6 Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024 F-7 Notes to Consolidated Financial Statements F-8 F-1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Shareholders and Board of Directors of Talphera, Inc.
Financial Statements and Supplementary Data The financial statements required by this item are attached to this Form 10-K beginning with page F-1. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. Item 9A.
Financial Statements and Supplementary Data The financial statements required by this item are attached to this Annual Report on Form 10-K beginning with page F-1. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. 55 Item 9A.
There were no material realized or unrealized gains or losses on marketable securities for the years ended December 31, 2024 or 2023. As such, we did not record a credit allowance for the year ended December 31, 2024 or 2023. Fair Value Measurement The Company’s financial instruments consist of Level I and II assets.
There were no material realized or unrealized gains or losses on marketable securities for the years ended December 31, 2025 or 2024. As such, the Company did not record a credit allowance for the year ended December 31, 2025 or 2024. Fair Value Measurement The Company’s financial instruments consist of Level I and II assets.
Sale of Future Payments In January 2024, the Company and XOMA entered into the Purchase Agreement for the sale by the Company to XOMA, in exchange for $8.0 million, of the Company’s right, title and interest in and to certain amounts payable to the Company, or collectively, the Purchased Receivables, pursuant to the DSUVIA Agreement in respect of net sales of the Product, excluding sales of the Product by Aguettant.
Sale of Future Payments In January 2024, the Company and XOMA entered into the Purchase Agreement for the sale by the Company to XOMA, in exchange for $8.0 million, of the Company’s right, title and interest in and to certain amounts payable to the Company, or collectively, the Purchased Receivables, pursuant to the DSUVIA Agreement in respect of net sales of the Product, excluding sales of the Product outside the United States by Laboratoire Aguettant, or Aguettant.
The difference in fair value of the effect of the Down Round Feature was immaterial in both instances and had no impact on net loss per share in the periods presented. This down round feature expired on August 3, 2023. As of December 31, 2024, the August 2022 LPC Warrant had not been exercised and was still outstanding.
The difference in fair value of the effect of the Down Round Feature was immaterial in both instances and had no impact on net loss per share in the periods presented. This down round feature expired on August 3, 2023. F-29 As of December 31, 2025, the August 2022 LPC Warrant had not been exercised and was still outstanding.
To date, we have incurred losses and generated negative cash flows from operations and we expect to incur significant losses in 2025 and may incur significant losses and negative cash flows from operations in the future.
To date, we have incurred losses and generated negative cash flows from operations and we expect to incur significant losses in 2026 and may incur significant losses and negative cash flows from operations in the future.
Refer to Note 7, “Sale of Future Payments” to the consolidated financial statements in this Annual Report on Form 10-K for further details on the Purchase Agreement and to Note 3, “Discontinued Operations” for further details on the Marketing Agreement.
Refer to Note 6, “Sale of Future Payments” to our consolidated financial statements in this Annual Report on Form 10-K for further details on the Purchase Agreement and to Note 3, “Discontinued Operations” for further details on the Marketing Agreement.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Signature Title Date /s/ Vincent J. Angotti Chief Executive Officer and Director March 31, 2025 Vincent J.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Signature Title Date /s/ Vincent J. Angotti Chief Executive Officer and Director March 23, 2026 Vincent J.
For additional information regarding the net income (loss) per share, see Note 12, “Net Loss per Share of Common Stock” to the consolidated financial statements in this Annual Report on Form 10-K.
For additional information regarding the net income (loss) per share, see Note 11, “Net Loss per Share of Common Stock” to our consolidated financial statements in this Annual Report on Form 10-K.
In order to determine the amortization of the liability related to the sale of future payments, the Company is required to estimate the total amount of future payments to XOMA over the life of the Purchase Agreement. In October 2024, Alora notified the Company that they are discontinuing their DSUVIA sales efforts to non-DoD customers.
In order to determine the amortization of the liability related to the sale of future payments, the Company is required to estimate the total amount of future payments to XOMA over the life of the Purchase Agreement. In October 2024, Alora notified the Company that they had discontinued their DSUVIA sales efforts to non-DoD customers.
The Loan Agreement Warrants have been classified within stockholders’ equity and accounted for as a discount to the loan by allocating the gross proceeds on a relative fair value basis. As of December 31, 2024, none of the Loan Agreement Warrants had been exercised and all remained outstanding. 11.
The Loan Agreement Warrants have been classified within stockholders’ equity and accounted for as a discount to the loan by allocating the gross proceeds on a relative fair value basis. As of December 31, 2025, none of the Loan Agreement Warrants had been exercised and all remained outstanding. 10.
Insider Trading Policy. 23.1 Consent of BPM LLP, Independent Registered Public Accounting Firm. 24.1 Power of Attorney (included in signature page). 31.1 Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended. 31.2 Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended. 32.1 Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Insider Trading Policy. 10-K 001-35068 10.1 03/31/2025 23.1 Consent of BPM LLP, Independent Registered Public Accounting Firm. 24.1 Power of Attorney (included in signature page). 31.1 Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended. 31.2 Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended. 32.1 Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
(b) Other segment income, net includes gain on sale of future payments, fair value adjustments to warrant liability, interest income and expense, and stock-based compensation expense and marketing support. 17.
(b) Other segment loss (income), net includes gain on sale of future payments, fair value adjustments to warrant liability, interest income and expense, and stock-based compensation expense and marketing support. 16.
The aggregate number of shares of the Company’s common stock that may be issued under the Amended 2020 Plan will not exceed the sum of: (i) 3,161,395 shares, and (ii) up to 744,608 shares subject to outstanding awards granted under the 2011 Equity Incentive Plan that may become available for issuance under the Amended 2020 Plan, as such shares become available from time to time.
Accordingly, the aggregate number of shares of the Company’s common stock that may be issued under the Amended 2020 Plan will not exceed the sum of: (i) 4,561,395 shares, and (ii) up to 744,608 shares subject to outstanding awards granted under the 2011 Equity Incentive Plan that may become available for issuance under the Amended 2020 Plan, as such shares become available from time to time.
As of December 31, 2024, total stock-based compensation expense related to unvested options to be recognized in future periods was $1.0 million which is expected to be recognized over a weighted-average period of 2.5 years. The grant date fair value of options vested during the years ended December 31, 2024 and 2023, was $2.0 million and $0.9 million, respectively.
As of December 31, 2025, total stock-based compensation expense related to unvested options to be recognized in future periods was $1.0 million which is expected to be recognized over a weighted-average period of 2.2 years. The grant date fair value of options vested during the years ended December 31, 2025 and 2024, was $0.7 million and $2.0 million, respectively.
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