What changed in PALVELLA THERAPEUTICS, INC.'s 2025 10-K compared to 2024?

Across the narrative sections we track, PALVELLA THERAPEUTICS, INC. (PVLA) added 277 paragraphs, removed 277, and edited 196 between the 2024 and 2025 10-K filings. The biggest movers are Item 6. [Reserved] (+270/−271), Item 1C. Cybersecurity (+7/−6).

Did PALVELLA THERAPEUTICS, INC. update its Cybersecurity disclosure (Item 1C) in 2025?

Item 1C Cybersecurity has 7 paragraph-level changes between the 2024 and 2025 filings.

Where does this PVLA 10-K diff come from?

The source filings are PALVELLA THERAPEUTICS, INC.'s official 2024 and 2025 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

What changed in PALVELLA THERAPEUTICS, INC.'s 10-K — 2024 vs 2025

Paragraph-level year-over-year comparison of PALVELLA THERAPEUTICS, 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.

+277 added−277 removedSource: 10-K (2026-03-31) vs 10-K (2025-03-31)

Top changes in PALVELLA THERAPEUTICS, INC.'s 2025 10-K

277 paragraphs added · 277 removed · 196 edited across 2 sections

Item 6. [Reserved]+270 / −271 · 190 edited
Item 1C. Cybersecurity+7 / −6 · 6 edited

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

6 edited+1 added−0 removed8 unchanged

2024 filing

2025 filing

Biggest changeMarket Information Our common stock is currently listed on the Nasdaq Capital Market under the symbol “PVLA.” Prior to the consummation of the Merger, our common stock was listed on the Nasdaq Capital Market under the symbol “PIRS.” As of March 25, 2025, we had 11,018,747 shares of common stock issued and outstanding held of record by 103 registered holders.

Biggest changeMarket Information Our common stock is currently listed on the Nasdaq Capital Market under the symbol “PVLA.” Prior to the consummation of the Merger, our common stock was listed on the Nasdaq Capital Market under the symbol “PIRS.” As of March 25, 2026, there were approximately 52 stockholders of record of our common stock.

On a quarterly basis, the Audit Committee discusses with senior management, and internal audit, if applicable, the Company’s processes for assessing, identifying, and managing material risks from cybersecurity threats and the state of the Company’s cybersecurity processes. The Audit Committee also receives updates on, and monitors, the Company’s prevention, detection, mitigation and remediation of cybersecurity incidents. 97 It em 2.

Recent Sales of Unregistered Securities We did not issue any equity securities during the year ended December 31, 2024 that were not registered under the Securities Act and that have not otherwise been described in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K.

Recent Sales of Unregistered Securities We did not issue any equity securities during the year ended December 31, 2025 that were not registered under the Securities Act and that have not otherwise been described in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K.

It em 4. Mine Safety Disclosures. Not applicable. 98 PART II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

It em 4. Mine Safety Disclosures. Not applicable. 105 PART II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the fiscal year ended December 31, 2024.

Issuer Purchases of Equity Securities We did not repurchase any of our equity securities during the fiscal year ended December 31, 2025.

Properties. Our principal executive office is located in Wayne, Pennsylvania, where we lease 3,379 square feet of space that we use for our administrative, research and development and other activities. We believe that our existing facilities are adequate for our near-term needs but expect to need additional space as we grow.

Our principal executive office is located in Wayne, Pennsylvania, where we lease 6,853 square feet of space that we use for our administrative, research and development and other activities. We believe that our existing facilities are 104 adequate for our near-term needs but expect to need additional space as we grow.

Added

This number does not include beneficial owners whose shares are held by brokers or other nominees in street name. Because many of our shares are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these record holders.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

190 edited+80 added−81 removed179 unchanged

2024 filing

2025 filing

Biggest changeCONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (in thousands, except share amounts) Convertible Additional Accumulated Other Total Preferred Stock Preferred Stock Common Stock Paid-in Comprehensive Accumulated Stockholders' Shares Amount Shares Amount Shares Amount Capital Income Deficit Equity (Deficit) Balance at December 31, 2022 15,360,787 $ 70,603 — $ — 1,770,167 $ 2 $ 1,213 $ — $ ( 94,992 ) $ ( 93,777 ) Stock-based compensation — — — — — — 603 — — 603 Net income — — — — — — — — 18,691 18,691 Balance at December 31, 2023 15,360,787 70,603 — $ — 1,770,167 $ 2 $ 1,816 $ — $ ( 76,301 ) $ ( 74,483 ) Conversion of convertible preferred stock into common stock in connection with Reverse Merger ( 15,360,787 ) ( 70,603 ) — — 4,753,650 5 70,598 — — 70,603 Conversion of convertible notes into common stock and prefunded warrants in connection with Reverse Merger — — — — 1,179,163 1 17,761 — — 17,762 Issuance of common stock and prefunded warrants in connection with PIPE — — — — 1,988,885 2 56,187 — — 56,189 Issuance of preferred stock and common stock to former stockholders of Pieris in connection with Reverse Merger — — 15,617 — 1,320,240 1 11,610 — — 11,611 Transactions costs associated with the Reverse Merger — — — — — — ( 2,474 ) — — ( 2,474 ) Stock-based compensation — — — — — — 830 — 830 Foreign currency translation gain — — — — — — — 3 — 3 Net loss — — — — — — — — ( 17,434 ) ( 17,434 ) Balance at December 31, 2024 — $ — 15,617 $ — 11,012,105 $ 11 $ 156,328 $ 3 $ ( 93,735 ) $ 62,607 The accompanying notes are an integral part of these consolidated financial statements.

Biggest changeC ONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (in thousands, except share amounts) Convertible Additional Accumulated Other Total Preferred Stock Preferred Stock Common Stock Paid-in Comprehensive Accumulated Stockholders' Shares Amount Shares Amount Shares Amount Capital Income (Loss) Deficit Equity Balance at December 31, 2023 15,360,787 70,603 — — 1,770,167 2 1,816 — ( 76,301 ) ( 74,483 ) Conversion of convertible preferred stock into common stock in connection with Reverse Merger ( 15,360,787 ) ( 70,603 ) — — 4,753,650 5 70,598 — — 70,603 Conversion of convertible notes into common stock and prefunded warrants in connection with Reverse Merger — — — — 1,179,163 1 17,761 — — 17,762 Issuance of common stock and prefunded warrants in connection with PIPE — — — — 1,988,885 2 56,187 — — 56,189 Issuance of preferred stock and common stock to former stockholders of Pieris in connection with Reverse Merger — — 15,617 — 1,320,240 1 11,610 — — 11,611 Transactions costs associated with the Reverse Merger — — — — — — ( 2,474 ) — — ( 2,474 ) Stock-based compensation — — — — — — 830 — 830 Foreign currency translation gain — — — — — — — 3 — 3 Net loss — — — — — — — — ( 17,434 ) ( 17,434 ) Balance at December 31, 2024 — $ — 15,617 $ — 11,012,105 $ 11 $ 156,328 $ 3 $ ( 93,735 ) $ 62,607 Exercise of common stock options for cash, net of expense — — — — 88,828 — 763 — — 763 Conversion of preferred stock into common stock — — ( 15,617 ) — 208,324 — — — — — Conversion of prefunded warrants into common stock — — — — 1,071,676 1 — — — 1 Equity issuance costs — — — — — — ( 154 ) — — ( 154 ) Stock-based compensation — — — — — — 6,401 — — 6,401 Foreign currency translation gain — — — — — — — 80 — 80 Net loss — — — — — — — — ( 41,715 ) ( 41,715 ) Balance at December 31, 2025 — $ — — $ — 12,380,933 $ 12 $ 163,338 $ 83 $ ( 135,450 ) $ 27,983 The accompanying notes are an integral part of these consolidated financial statements.

Management estimates the fair value of the stock option awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the fair value of the Company’s common stock, (b) the expected stock price volatility, (c) the calculation of expected term of the award, (d) the risk-free interest rate and (e) expected dividends.

Management estimates the fair value of the restricted stock awards using the fair value of the Company’s common stock. Forfeitures are recognized as they are incurred.

The expected life of the stock options in years is estimated using the “simplified method,” as prescribed in SEC’s Staff Accounting Bulletin (SAB) No. 107, as the Company has no historical information from which to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock option grants.

In the event of the Company’s liquidation, dissolution or winding up, subject to the rights of holders of, holders are entitled to receive a payment equal to $ 0.001 per share of Preferred Stock pursuant to the rights and preferences discussed above, plus an additional amount equal to any dividends declared but unpaid on such shares.

In the event of the Company’s liquidation, dissolution or winding up, subject to the rights of holders of Preferred Stock, holders are entitled to receive a payment equal to $ 0.001 per share of Preferred Stock pursuant to the rights and preferences discussed above, plus an additional amount equal to any dividends declared but unpaid on such shares.

Under current German laws, tax loss carryforwards may only be used to offset any relevant later assessment period (calendar year) of $ 1.2 million plus 60 % of the exceeding taxable income and trade profit of such period and do not expire.

The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including: • timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and may depend substantially upon the performance of certain third-party contractors; • delays in validating, or inability to validate, any endpoints utilized in a clinical trial; • the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if any, or experienced by competitors who are developing topical rapamycin products or who are targeting the same indications in the rare genetic skin diseases space; • the ability of CMOs upon which we rely to manufacture clinical supplies of our product candidates or any future product candidates to remain in good standing with relevant regulatory authorities and to develop, validate and maintain commercially viable manufacturing processes that are compliant with cGMP; • our ability to retain patients who have enrolled in a clinical study but may be prone to withdraw due to the rigors of the clinical trial, lack of efficacy, side effects, personal issues or loss of interest; • our ability to establish and enforce intellectual property rights in and to our current product candidates or any future product candidates; and • minimizing and managing any delay or disruption to our ongoing or planned clinical trials.

The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including: • timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and may depend substantially upon the performance of certain third-party contractors; • delays in validating, or inability to validate, any endpoints utilized in a clinical trial; • the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if any, or experienced by competitors who are developing topical rapamycin products or who are targeting the same indications in the rare skin diseases space; • the ability of CMOs upon which we rely to manufacture clinical supplies of our product candidates or any future product candidates to remain in good standing with relevant regulatory authorities and to develop, validate and maintain commercially viable manufacturing processes that are compliant with cGMP; • our ability to retain patients who have enrolled in a clinical study but may be prone to withdraw due to the rigors of the clinical trial, lack of efficacy, side effects, personal issues or loss of interest; 112 • our ability to establish and enforce intellectual property rights in and to our current product candidates or any future product candidates; and • minimizing and managing any delay or disruption to our ongoing or planned clinical trials.

The following table summarizes the fair value of identifiable assets acquired and liabilities assumed as part of the recapitalization (in thousands): As of December 13, 2024 Assets Current assets: Cash $ 13,781 Accounts receivable 377 Prepaid expenses and other current assets 595 Total current assets 14,753 Total assets $ 14,753 Liabilities Current liabilities: Accounts payable $ 142 Accrued expenses and other current liabilities 3,000 Total current liabilities 3,142 Total liabilities $ 3,142 Net assets acquired $ 11,611 In connection with the Reverse Merger, the Company incurred transaction costs of $ 2.5 million.

F- 14 The following table summarizes the fair value of identifiable assets acquired and liabilities assumed as part of the recapitalization (in thousands): As of December 13, 2024 Assets Current assets: Cash $ 13,781 Accounts receivable 377 Prepaid expenses and other current assets 595 Total current assets 14,753 Total assets $ 14,753 Liabilities Current liabilities: Accounts payable $ 142 Accrued expenses and other current liabilities 3,000 Total current liabilities 3,142 Total liabilities $ 3,142 Net assets acquired $ 11,611 In connection with the Reverse Merger, the Company incurred transaction costs of $ 2.5 million.

The registrant hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules upon request by the SEC. + Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(a)(6). # Certain confidential information contained in this exhibit, marked by brackets, has been omitted pursuant to Item 601(b)(10)(iv) because the information (i) is not material and (ii) is the type of information that the Registrant both customarily and actually treats as private and confidential. * Indicates management contract or compensatory plan 123 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .

The registrant hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules upon request by the SEC. + Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(a)(6). # Certain confidential information contained in this exhibit, marked by brackets, has been omitted pursuant to Item 601(b)(10)(iv) because the information (i) is not material and (ii) is the type of information that the Registrant both customarily and actually treats as private and confidential. * Indicates management contract or compensatory plan 130 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .

The estimated future net sales are based on subjective assumptions that include the estimated size of the addressable patient population and the anticipated pricing of the Company’s products. These assumptions are subject to significant variability, and are thus subject to significant uncertainty. Royalty payments will be recorded as debt service payments on the royalty agreement liability.

The estimated future net sales are based on subjective 120 assumptions that include the estimated size of the addressable patient population and the anticipated pricing of the Company’s products. These assumptions are subject to significant variability, and are thus subject to significant uncertainty. Royalty payments will be recorded as debt service payments on the royalty agreement liability.

Our payment obligations under these contracts generally provide for termination upon notice and, therefore, we believe that our non-cancelable obligations under these agreements are not material and we cannot reasonably estimate the timing of any such payments or if and when they will occur.

Our payment obligations under these contracts generally provide for termination upon notice and, therefore, we believe that our 119 non-cancelable obligations under these agreements are not material and we cannot reasonably estimate the timing of any such payments or if and when they will occur.

Series A, Series B, Series C, Series D and Series E Preferred Stock rank senior to the Company’s common stock; senior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as junior to the five series of Preferred Stock; in parity with each other and with any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as in parity with the existing five series of Preferred Stock; and junior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as senior to the existing five series of Preferred Stock.

Series A, Series B, Series C, Series D and Series E Preferred Stock rank senior to Common Stock; senior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as junior to the five series of Preferred Stock; in parity with each other and with any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as in parity with the existing five series of Preferred Stock; and junior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as senior to the existing five series of Preferred Stock.

Product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages, 103 primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development.

Product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development.

Subsequent to the Closing Date and as of December 31, 2024, a $2.0 million German research and development tax 107 credit receivable was recorded by Pieris Pharmaceuticals GmbH resulting in a corresponding increase to the contingent value rights liability.

Subsequent to the Closing Date and as of December 31, 2024, a $2.0 million German research and development tax credit receivable was recorded by Pieris Pharmaceuticals GmbH resulting in a corresponding increase to the contingent value rights liability.

Following the completion of the Merger, we also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well 104 as investor and public relations expenses associated with our operations as a public company.

Following the completion of the Merger, we also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with our operations as a public company.

Research and Development Expenses Our research and development expenses consist primarily of costs incurred for the development of its product candidates, which include: • costs related to production of preclinical and clinical materials, including CMC fees paid to CMOs; • personnel costs, including salaries, related benefits and stock-based compensation expense for employees engaged in research and development functions; • vendor expenses related to the execution of preclinical studies and clinical trials; • expenses incurred under agreements with consultants that conduct research and development activities on our behalf; • costs related to compliance with regulatory requirements; and • allocated overhead, including rent, equipment and information technology costs.

Research and Development Expenses Our research and development expenses consist primarily of costs incurred for the development of our product candidates, which include: • costs related to production of preclinical and clinical materials, including CMC fees paid to CMOs; • personnel costs, including salaries, related benefits and stock-based compensation expense for employees engaged in research and development functions; 111 • vendor expenses related to the execution of preclinical studies and clinical trials; • expenses incurred under agreements with consultants that conduct research and development activities on our behalf; • costs related to compliance with regulatory requirements; and • allocated overhead, including rent, equipment and information technology costs.

In addition, we agreed to pay to Ligand tiered royalties from 8.0% to 9.8% based on any aggregate annual worldwide net product sales of any products based on QTORIN rapamycin.

In addition, we agreed to pay to Ligand tiered royalties ranging from 8.0% to 9.8% of any aggregate annual worldwide net product sales of any products based on QTORIN rapamycin.

The CODM views the Company’s operations as a single operating segment which is the business of discovering and developing products for individuals with serious and rare genetic skin diseases.

The CODM views the Company’s operations as a single operating segment which is the business of discovering and developing products for individuals with serious and rare skin diseases.

We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and therefore we are permitted to provide a scaled Item 8 disclosure. There have been no retrospective changes to our consolidated statements of operations for any of the quarters within the two years ended December 31, 2024. It em 9.

Page number in this Report Report of Independent Registered Public Accounting Firm F- 2 Consolidated Balance Sheets at December 31, 2024 and 2023 F- 4 Consolidated Statements of Operations and Comprehensive (Loss) Income for the years ended December 31, 2024 and 2023 F- 5 Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2024 and 2023 F- 6 Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023 F- 7 Notes to Consolidated Financial Statements F- 8 (2) We are not filing any financial statement schedules as part of this Annual Report on Form 10-K because they are not applicable or the required information is included in the financial statements or notes thereto.

Page number in this Report Report of Independent Registered Public Accounting Firm F- 2 Consolidated Balance Sheets at December 31, 2025 and 2024 F- 4 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025 and 2024 F- 5 Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) 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 (2) We are not filing any financial statement schedules as part of this Annual Report on Form 10-K because they are not applicable or the required information is included in the financial statements or notes thereto.

The Company expects to primarily generate revenue in North America, with its long-lived assets also concentrated in this region, and manages its business activities on a consolidated basis. Decisions concerning the allocation of the Company’s resources are made by the Company’s Chief Operating Decision Maker (CODM), which is the Company’s Chief Executive Officer (CEO).

Reverse Merger and PIPE Financing On December 13, 2024 (the “Closing Date”), the Company consummated the previously announced merger pursuant to the terms of that certain Agreement and Plan of Merger, dated as of July 23, 2024 (the “Merger Agreement”), by and among the Company, Polo Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Pieris (the “Merger Sub”), and Palvella Therapeutics, Inc., a Delaware corporation (“Legacy Palvella”).

Reverse Merger On December 13, 2024 (the “Closing Date”), the Company consummated the previously announced merger pursuant to the terms of that certain Agreement and Plan of Merger, dated as of July 23, 2024 (the “Merger Agreement”), by and among the Company, Polo Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Pieris (the “Merger Sub”), and Palvella Therapeutics, Inc., a Delaware corporation (“Legacy Palvella”).

Our obligation to make milestone payments under 112 the Amended Ligand Agreement was determined to be a derivative liability, and our obligation to make future royalty payments was determined to be a debt instrument.

Our obligation to make milestone payments under the Amended Ligand Agreement was determined to be a derivative liability, and our obligation to make future royalty payments was determined to be a debt instrument.

The information required by this item is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024. It em 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2025. It em 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

We tested that the revenue projections were updated based on the most recent clinical trial data received in 2024 and recalculated the current year interest expense. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2018. Philadelphia, Pennsylvania March 31, 2025 F- 3 PALVELLA THERAPEUTICS, INC.

We tested that the revenue projections were updated based on the most recent clinical trial data received in 2025 and recalculated the current year interest expense. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2018. Philadelphia, Pennsylvania March 31, 2026 F- 3 PALVELLA THERAPEUTICS, INC.

The Company recorded its obligation to pay tiered royalties under the Ligand Agreement as a debt instrument (royalty agreement liability) on the balance sheet at a carrying value of $11.9M as of December 31, 2024 and has recognized imputed interest expense of $3.9M for the year ended December 31, 2024 using the effective interest rate method.

The Company recorded its obligation to pay tiered royalties under the Ligand Agreement as a debt instrument (royalty agreement liability) on the balance sheet at a carrying value of $11.9M as of December 31, 2025 and has recognized imputed interest expense of $3.9M for the year ended December 31, 2025 using the effective interest rate method.

While our management is closely monitoring the impact of the current macroeconomic conditions on all aspects of our business, including the impacts on its participants in its Phase 3 clinical trials, employees, suppliers, vendors and business partners, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve.

While our management is closely monitoring the impact of the current macroeconomic conditions on all aspects of our business, including the impacts on its participants in its clinical trials, employees, suppliers, vendors and business partners, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve.

Palvella Therapeutics, Inc. By: Date: March 31, 2025 /s/ Wesley H. Kaupinen Wesley H. Kaupinen President and Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.

Palvella Therapeutics, Inc. By: Date: March 31, 2026 /s/ Wesley H. Kaupinen Wesley H. Kaupinen President and Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.

The information required by this item is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024. It em 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2025. It em 13. Certain Relationships and Related Transactions, and Director Independence.

In each case, each share Preferred Stock is convertible into 13.34 shares of the Company's common stock (subject to adjustment as provided in the Certificate of Designation for each series) at any time at the option of the holder, provided that the holder is prohibited from converting the Preferred Stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 % of the total number of shares of Common Stock then issued and outstanding, or the Beneficial F- 24 Ownership Limitation.

In each case, each share Preferred Stock is convertible into 13.34 shares of the Common Stock (subject to adjustment as provided in the Certificate of Designation for each series) at any time at the option of the holder, provided that the holder is prohibited from converting the Preferred Stock into shares of Common Stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 F- 20 % of the total number of shares of Common Stock then issued and outstanding, or the Beneficial Ownership Limitation.

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at 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 U.S. generally accepted accounting principles.

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at 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 U.S. generally accepted accounting principles.

The Company’s Series A-1, Series A-2 and Series B, Series C, and Series D preferred stock (collectively, “convertible preferred stock”) was subject to certain pre-existing anti-dilution provisions that were triggered upon the closing of the PIPE Financing. The private placement in the Company closed immediately before the Closing.

F- 19 The Company’s Series A-1, Series A-2 and Series B, Series C, and Series D preferred stock (collectively, “convertible preferred stock”) was subject to certain pre-existing anti-dilution provisions that were triggered upon the closing of the PIPE Financing. The private placement in the Company closed immediately before the Closing.

As of December 31, 2024, the Company operations segment has not generated any product revenue since inception, as it does not yet have approved products for sale. However, the Company operations segment anticipates future revenue generation upon the successful development and commercialization of product candidates either independently or through partnerships.

As of December 31, 2025, the Company operations segment has not generated any product revenue since inception, as it does not yet have approved products for sale. However, the Company operations segment anticipates future revenue generation upon the successful development and commercialization of product candidates either independently or through partnerships.

The Company’s effective interest rate calculation includes probability-adjusted revenue projections for which future royalties will be paid, which are sensitive to significant assumptions including the size of the addressable patient population, the anticipated pricing of the Company’s products, and the probability of successful development and commercialization., among others.

Item 6. [ Reserved] 99 It em 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated audited financial statements and accompanying notes appearing elsewhere in this Form 10-K.

Item 6. [ Reserved] 106 It em 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated audited financial statements and accompanying notes appearing elsewhere in this Form 10-K.

For those income tax positions for which it is not more likely than not that a tax benefit will be sustained, no tax benefit is recognized in the consolidated financial statements. We had no provision for income taxes for the years ended December 31, 2024 and 2023.

At the effective time of the Reverse Merger, each issued and outstanding share of the Company convertible preferred stock converted automatically into 0.309469242 shares of the Company’s common stock, at the option of the preferred shareholder. At the Closing, the Company issued an aggregate of 4,753,650 shares of its common stock to the Company’s preferred shareholders.

GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements and notes as of December 31, 2024 and December 31, 2023 include the accounts of the Company and its subsidiaries. All intercompany balances and transactions are eliminated in consolidation.

GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements and notes as of December 31, 2025 and 2024 include the accounts of the Company and its subsidiaries. All intercompany balances and transactions are eliminated in consolidation.

F- 10 Comprehensive (Loss) Income and Accumulated Other Comprehensive (Loss) Income Other comprehensive (loss) income is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.

F- 9 Comprehensive Loss and Accumulated Other Comprehensive (Loss) Income Other comprehensive (loss) income is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.

F- 11 The derivative liabilities – royalty agreement was initially recorded at fair value, with gains and losses arising for changes in fair value of the derivative liabilities – royalty agreement recognized within the consolidated statements of operations as fair value adjustments on the derivative liabilities at each financial reporting period.

F- 10 The derivative liabilities – royalty agreement was initially recorded at fair value, with gains and losses arising for changes in fair value of the derivative liabilities – royalty agreement recognized within the consolidated statements of operations as fair value adjustments on the derivative liabilities at each financial reporting period.

Upon the closing of the PIPE Financing, the entire outstanding principal amount and unpaid accrued interest on the convertible notes automatically converted into an aggregate of 1,179,163 shares of common stock and 168,503 prefunded warrants.

Upon the closing of the PIPE Financing (defined above), the entire outstanding principal amount and unpaid accrued interest on the convertible notes automatically converted into an aggregate of 1,179,163 shares of Common Stock and 168,503 prefunded warrants.

Cash and Cash Equivalents Cash and cash equivalents are held in accounts at two independent financial institutions. Cash equivalents are defined as money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

Cash and Cash Equivalents Cash and cash equivalents are held in accounts at multiple independent financial institutions. Cash equivalents are defined as money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

The Series D Preferred also contains a Milestone Closing option for additional shares to be issued following the Company’s receipt of clinical data for the top line Phase 3 data results for QTORIN rapamycin for pachyonychia congenita.

The Series D Preferred also contained a Milestone Closing option for additional shares to be issued following the Company’s receipt of clinical data for the top line Phase 3 data results for QTORIN rapamycin for pachyonychia congenita.

In addition, certain transactions, including transfers of shares or interest in the loss holding entity, may result in the partial or total forfeiture of tax losses existing at that date. Partial or total forfeiture of tax losses may further occur in corporate reorganizations of the loss holding entity Note 12.

In connection with the issuance of the Series D Preferred, the Company amended and restated its certificate of incorporation (as amended, the “Amended Certificate”) such that it is authorized to issue 29,000,000 shares of common stock ( 25,500,000 voting and 3,500,000 non-voting) and 20,655,895 shares of preferred stock, with 2,241,903 shares designated as Series A-1 Convertible Preferred stock (Series A-1 Preferred”), 1,240,134 shares designated as Series A-2 Convertible Preferred stock (“Series A-2 Preferred”), 1,533,528 shares designated as Series F- 21 B Convertible Preferred stock (“Series B Preferred”), 8,509,995 shares designated as Series C Convertible Preferred stock (“Series C Preferred”) and 7,130,335 shares designated as Series D Preferred.

In connection with the issuance of the Series D Preferred, the Company amended and restated its certificate of incorporation (as amended, the “Amended Certificate”) such that it was authorized to issue 29,000,000 shares of common stock ( 25,500,000 voting and 3,500,000 non-voting) and 20,655,895 shares of preferred stock, with 2,241,903 shares designated as Series A-1 Convertible Preferred stock (“Series A-1 Preferred”), 1,240,134 shares designated as Series A-2 Convertible Preferred stock (“Series A-2 Preferred”), 1,533,528 shares designated as Series B Convertible Preferred stock (“Series B Preferred”), 8,509,995 shares designated as Series C Convertible Preferred stock (“Series C Preferred”) and 7,130,335 shares designated as Series D Preferred.

At December 31, 2024 and 2023, the carrying amounts of financial instruments, which include cash and cash equivalents, accounts payable, and accrued expenses and other liabilities, approximate their fair value due to their short maturities.

At December 31, 2025 and 2024, the carrying amounts of financial instruments, which include cash and cash equivalents, accounts payable, and accrued expenses and other liabilities, approximate their fair value due to their short maturities.

Since inception, the Company has devoted substantially all of its time to identifying, researching and conducting preclinical and clinical activities for its product candidates, acquiring and developing its platform technology, organizing and staffing the Company, business planning, raising capital and establishing its intellectual property portfolio. The Company’s principal executive offices are located in Wayne, Pennsylvania.

Since inception, the Company has devoted substantially all of its resources to identifying, researching and conducting preclinical and clinical activities for its product candidates, and developing its platform technology, organizing and staffing the Company, business planning, raising capital and establishing its intellectual property portfolio. The Company’s principal executive offices are located in Wayne, Pennsylvania.

Interest expense - convertible notes payable During the year ended December 31, 2024, we recorded interest expense of approximately $0.4 million related to the Convertible Notes, which were issued during the year ended December 31, 2024. No such expense was incurred during 2023.

Name Title Date /s/ Wesley H. Kaupinen President, Chief Executive Officer and Director March 31, 2025 Wesley H. Kaupinen (principal executive officer) /s/ Matthew E. Korenberg Chief Financial Officer and Treasurer March 31, 2025 Matthew E. Korenberg (principal financial officer and principal accounting officer) /s/ George M. Jenkins Chairman March 31, 2025 George M. Jenkins /s/ Todd C.

Name Title Date /s/ Wesley H. Kaupinen President, Chief Executive Officer and Director March 31, 2026 Wesley H. Kaupinen (principal executive officer) /s/ Matthew E. Korenberg Chief Financial Officer and Treasurer March 31, 2026 Matthew E. Korenberg (principal financial officer and principal accounting officer) /s/ George M. Jenkins Chairman March 31, 2026 George M. Jenkins /s/ Todd C.

F- 13 The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position.

The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position.

(3) The list of Exhibits filed as part of this Annual Report on Form 10-K is set forth on the Exhibit Index below. (b) The list of Exhibits filed as part of this Annual Report on Form 10-K is set forth on the Exhibit Index below. (c) None. 118 It em 16.

The effective interest rate is estimated at each balance sheet date based on the F- 2 rate that would enable the liability to be repaid in full over the anticipated life of the arrangement.

The effective interest rate is estimated at each balance sheet date based on the rate that would enable the liability to be repaid in full over the anticipated life of the arrangement.

The effective interest rate may vary during the term of the Ligand Agreement based on changes in the probability-adjusted cash flow estimates of the Company’s potential future royalty payments under the Ligand Agreement.

The effective interest rate may vary during the term of the Ligand Agreement F- 2 based on changes in the probability-adjusted cash flow estimates of the Company’s potential future royalty payments under the Ligand Agreement.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. 116 PART III It em 10. Directors, Executive Officers and Corporate Governance. The information required by this item is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. 123 PART III It em 10. Directors, Executive Officers and Corporate Governance. The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2025.

F- 7 PALVELLA THERAPEUTICS, INC. N OTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1. Description of Business, Organization and Liquidity Business Palvella Therapeutics, Inc. (the “Company,” or “Palvella”) (previously named Pieris Pharmaceuticals, Inc. and predecessor company (“Pieris”)), a Nevada corporation, is a late clinical-stage biopharmaceutical company committed to serving individuals suffering from serious, rare genetic skin diseases without approved therapies.

F- 7 PALVELLA THERAPEUTICS, INC. N OTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1. Description of Business, Organization and Liquidity Business Palvella Therapeutics, Inc. (the “Company,” or “Palvella”) (previously named Pieris Pharmaceuticals, Inc. (“Pieris”)), a Nevada corporation, is a late clinical-stage biopharmaceutical company committed to serving individuals suffering from serious, rare skin diseases and vascular malformations without approved therapies.

(the Company) as of December 31, 2024 and 2023, and the related consolidated statements of operations and comprehensive (loss) income, changes in convertible preferred stock and stockholders' equity (deficit) 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, the related consolidated statements of operations and comprehensive loss, changes in convertible preferred stock and stockholders' equity (deficit), 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”).

Based on the following factors, the Company determined under the Accounting Standards Codification (“ASC”) 805, Business Combinations , that the Reverse Merger should be accounted for as a reverse recapitalization: • The Company stockholders owned approximately 60 % of the voting rights in the Company, and thus had sufficient voting rights to exert influence over the Company. • The Company designated a majority of the Company’s board of directors and maintained a majority of the composition of management. • At the time of Closing, Pieris did not meet the definition of a business and had nominal assets, meeting the definition of a public shell company.

Based on the following factors, the Company determined under the ASC 805, Business Combinations , that the Reverse Merger should be accounted for as a reverse recapitalization: • The Company stockholders owned approximately 60 % of the voting rights in the Company and thus had sufficient voting rights to exert influence over the Company. • The Company designated a majority of the Company’s board of directors and maintained a majority of the composition of management. • At the time of Closing, Pieris did not meet the definition of a business and had nominal assets, meeting the definition of a public shell company.

The Reverse Merger was contemplated and consummated, along with the PIPE Financing, to generate capital resources to support the advancement of the Company’s pipeline and future operations.

The Reverse Merger was contemplated and consummated, along with the PIPE Financing (defined below), to generate capital resources to support the advancement of the Company’s pipeline and future operations.

The information required by this item is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2024. 117 PART IV It em 15. Exhibits, Financial Statement Schedules. (a) (1) Financial Statements.

The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2025. 124 PART IV It em 15. Exhibits, Financial Statement Schedules. (a) (1) Financial Statements.

F- 8 On December 13, 2024, immediately prior to Closing, Pieris entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent, pursuant to which holders of Pieris common stock prior to Closing received one non-transferable contingent value right (each, a “CVR”) for each outstanding share of Pieris common stock held by such stockholder immediately prior to Closing.

Contingent Value Rights Agreement On December 13, 2024, immediately prior to the Effective Time, Pieris entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent, pursuant to which holders of Pieris common stock prior to Closing received one non-transferable contingent value right (each, a “CVR”) for each outstanding share of Pieris common stock held by such stockholder immediately prior to Closing.

The Company determined that certain contingent payments that may become payable under the CVR Agreement related to the asset sales prior to the Reverse Merger qualified as derivatives under ASC 815. Upon such time that these payments are assessed a fair value, they would be recorded as a liability on the balance sheet.

The Company determined that certain contingent payments that may become payable under the CVR Agreement related to the asset sales prior to the Reverse Merger qualified as derivatives under ASC 815. Upon such time that these payments were assessed a fair value, they were recorded as a liability on the balance sheet.

Interest expense with respect to the royalty agreement liability is determined using the effective interest method based upon probability-adjusted cash flow estimates of the Company’s potential future royalty payments under the Ligand Agreement, yielding an effective interest rate of 39.9 % and 38.9 % as of December 31, 2024 and 2023, respectively.

Interest expense with respect to the royalty agreement liability is determined using the effective interest method based upon probability-adjusted cash flow estimates of the Company’s potential future royalty payments under the Ligand Agreement, yielding an effective interest rate of 44.9 % and 39.9 % as of December 31, 2025 and 2024, respectively.

For the year ended December 31, 2024, cash flows from financing activities was primarily attributable to $13.8 million of cash acquired in connection with the Business Combination, $60.0 million in gross proceeds from the PIPE Financing, and $18.4 million in gross proceeds from the issuance of the Convertible Notes, partially offset by payment of transaction costs in connection with Business Combination of $2.5 million, payments of transaction costs associated with PIPE Financing of $2.5 million, and payments of transaction costs to issue the Convertible Notes of $0.1 million.

For the year ended December 31, 2024, net cash provided by financing activities was $87.1 million, which was primarily attributable to $13.8 million of cash acquired in connection with the Business Combination, $60.0 million in gross proceeds from the PIPE Financing, and $18.4 million in gross proceeds from the issuance of the Convertible Notes, partially offset by payment of transaction costs in connection with Business Combination of $2.5 million, payments of transaction costs associated with PIPE Financing of $2.5 million, and payments of transaction costs to issue the Convertible Notes of $0.1 million.

S-4 333-281459 10.24 August 9, 2024 10.18* Offer Letter, dated July 27, 2020, by and between Jeffrey Martini and Palvella Therapeutics, Inc. S-4 333-281459 10.25 August 9, 2024 10.19* Offer Letter, dated August 19, 2019, by and between Kathleen Goin and Palvella Therapeutics, Inc.

S-4 333-281459 10.24 August 9, 2024 10.16* Offer Letter, dated July 27, 2020, by and between Jeffrey Martini and Palvella Therapeutics, Inc. S-4 333-281459 10.25 August 9, 2024 10.17* Offer Letter, dated August 19, 2019, by and between Kathleen Goin and Palvella Therapeutics, Inc.

S-4/A 333-281459 10.18 November 5, 2024 10.14 First Amendment to Development Funding and Royalties Agreement, dated May 22, 2020, by and between Ligand Pharmaceuticals, Inc. and Palvella Therapeutics, Inc. S-4 333-281459 10.19 August 9, 2024 10.15# Second Amendment to Development Funding and Royalties Agreement, dated November 28, 2023, by and between Ligand Pharmaceuticals, Inc. and Palvella Therapeutics, Inc.

S-4/A 333-281459 10.18 November 5, 2024 10.12 First Amendment to Development Funding and Royalties Agreement, dated May 22, 2020, by and between Ligand Pharmaceuticals, Inc. and Palvella Therapeutics, Inc. S-4 333-281459 10.19 August 9, 2024 10.13# Second Amendment to Development Funding and Royalties Agreement, dated November 28, 2023, by and between Ligand Pharmaceuticals, Inc. and Palvella Therapeutics, Inc.

Assuming no additional fund raising, the Company’s forecasted cash required to fund operations indicates that the Company has sufficient funds to support operations through the one-year period from the issuance date of these consolidated financial statements. F- 9 Note 2.

Assuming no additional fund raising, the Company’s forecasted cash required to fund operations indicates that the Company has sufficient funds to support operations through at least the one-year period from the issuance date of these consolidated financial statements. F- 8 Note 2.

Other (Expense) Income Our other (expense) income for the years ended December 31, 2024 and 2023 primarily consists of: (i) non-cash interest (expense) income related to our obligation to make future royalty payments pursuant to the Ligand Agreements, which was determined to be a debt instrument; (ii) interest expense related to the Convertible Notes; (iii) fair value adjustments related to our obligation to make future milestone payments under the Amended Ligand Agreement, which was determined to be a derivative liability; (iv) fair value adjustments related to the Convertible Notes, which were accounted for at fair value; (v) fair value adjustments related to the CVRs, which met the definition of a derivative, (vi) a non-cash gain on the extinguishment of the Original Ligand Agreement, and (vii) income related to a German R&D tax credit receivable.

Other (Expense) Income Our other (expense) income for the years ended December 31, 2025 and 2024 primarily consists of: (i) non-cash interest expense related to our obligation to make future royalty payments pursuant to the Amended Ligand Agreement, which was determined to be a debt instrument; (ii) interest expense related to the Convertible Notes; (iii) fair value adjustments related to our obligation to make future milestone payments under the Amended Ligand Agreement, which was determined to be a derivative liability; (iv) fair value adjustments related to the Convertible Notes, which were accounted for at fair value; (v) fair value adjustments related to the CVRs, which met the definition of a derivative, (vi) income related to a German R&D tax credit receivable, and (vii) interest income, net.

Interest expense is determined using the effective interest method based upon risk adjusted cash flow estimates of our expected future royalty payments, yielding an effective interest rate of 39.9% and 38.9% as of December 31, 2024 and 2023, respectively.

Interest expense is determined using the effective interest method based upon risk adjusted cash flow estimates of our expected future royalty payments, yielding an effective interest rate of 44.9% and 39.9% as of December 31, 2025 and 2024, respectively.

Form 10-K Summary Not applicable. 119 Exhibit Index Incorporated by Reference (if applicable) Exhibit Number Exhibit Description Form File No.

Form 10-K Summary Not applicable. 126 Exhibit Index Incorporated by Reference (if applicable) Exhibit Number Exhibit Description Form File No.

The Company records its derivative liabilities and convertible notes payable at fair value. Derivative Instruments The Company evaluates its contracts to determine if those contracts qualify as derivatives under ASC 815, Derivatives and Hedging.

The Company records its derivative liabilities at fair value. Derivative Instruments The Company evaluates its contracts to determine if those contracts qualify as derivatives under ASC 815, Derivatives and Hedging .

S-4/A 333-281459 10.20 November 5, 2024 10.16* Employment Agreement, dated May 20, 2020, by and between Wesley Kaupinen and Palvella Therapeutics, Inc. S-4 333-281459 10.21 August 9, 2024 10.17* Severance Agreement, dated May 22, 2020, by and between Kathleen Goin and Palvella Therapeutics, Inc.

S-4/A 333-281459 10.20 November 5, 2024 10.14* Employment Agreement, dated May 20, 2020, by and between Wesley Kaupinen and Palvella Therapeutics, Inc. S-4 333-281459 10.21 August 9, 2024 10.15* Severance Agreement, dated May 22, 2020, by and between Kathleen Goin and Palvella Therapeutics, Inc.

Davis Director March 31, 2025 Todd C. Davis /s/ Elaine J. Heron, PhD Director March 31, 2025 Elaine J. Heron, PhD /s/ Christopher Kiritsy Director March 31, 2025 Christopher Kiritsy /s/ Tadd S. Wessel Director March 31, 2025 Tadd S.

Davis Director March 31, 2026 Todd C. Davis /s/ Elaine J. Heron, PhD Director March 31, 2026 Elaine J. Heron, PhD /s/ Christopher Kiritsy Director March 31, 2026 Christopher Kiritsy /s/ Tadd S. Wessel Director March 31, 2026 Tadd S.

Commitments and Contingencies Litigation From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated. F- 28 Note 13.

Commitments and Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.

Disclosure Controls and Procedures Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2024.

Evaluation of Disclosure Controls and Procedures. 122 Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2025.

Assumptions Used in Determining Fair Value of Derivative Liabilities The key assumptions used to determine the fair value of the derivative liabilities – royalty agreement at December 31, 2024 and 2023 are as follows: December 31, 2024 2023 Discount rate 20.0 % 25.0 % Probability rate of achieving FDA approval of a product 56.6 % 50.0 % Expected term to FDA regulatory approval of a product 2.5 years 3.5 years F- 17 Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis The following table provides a reconciliation of the liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands): Derivative Liabilities – Royalty Agreement 2024 2023 Derivative liabilities - royalty agreement Balance at January 1 $ 1,014 $ 1,499 Fair value adjustments on derivative liabilities 633 ( 485 ) Balance at December 31 $ 1,647 $ 1,014 The derivative liabilities – royalty agreement is classified as long term on the Company’s consolidated balance sheets according to the estimated timing of the occurrence of the potential payments.

Assumptions Used in Determining Fair Value of Derivative Liabilities The key assumptions used to determine the fair value of the derivative liabilities – royalty agreement at December 31, 2025 and 2024 are as follows: December 31, 2025 December 31, 2024 Discount rate 18.0 % 20.0 % Probability rate of achieving FDA approval of a product 56.6 % 56.6 % Expected term to FDA regulatory approval of a product 1.50 years 2.50 years F- 16 Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis The following table provides a reconciliation of the liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands): Derivative Liabilities – Royalty Agreement 2025 2024 Derivative liabilities - royalty agreement Balance at January 1 $ 1,647 $ 1,014 Fair value adjustments on derivative liabilities 394 633 Balance at December 31, 2025 $ 2,041 $ 1,647 The derivative liabilities – royalty agreement is classified as long term on the Company’s consolidated balance sheets according to the estimated timing of the occurrence of the potential payments.

Derivative Liabilities – Contingent Value Right Liability 2024 2023 Derivative liabilities - contingent value rights Balance at January 1 $ — $ — Fair value adjustments on derivative liabilities 1,978 — Balance at December 31 $ 1,978 $ — The derivative liabilities – contingent value rights is classified as short term on the Company’s consolidated balance sheets according to the estimated timing of the occurrence of the potential payments.

Derivative Liabilities – Contingent Value Right Liability 2025 2024 Derivative liabilities - contingent value right liability Balance at January 1 $ 1,978 $ — Fair value adjustments on derivative liabilities 218 1,978 Balance at December 31, 2025 $ 2,196 $ 1,978 The derivative liabilities – contingent value rights is classified as short term on the Company’s consolidated balance sheets according to the estimated timing of the occurrence of the potential payments.

As partial consideration for the one-time payment, the Company granted Ligand the right to receive up to $ 8.0 million in milestone payments upon the achievement of certain corporate, financing and regulatory milestones by the Company related to QTORIN rapamycin for the treatment of any and all indications.

As partial consideration for the funding received, the Company granted Ligand the right to receive up to $ 8.0 million in milestone payments upon the achievement of certain corporate, financing and regulatory milestones by the Company related to QTORIN rapamycin for the treatment of any and all indications.

For additional information, see Part I, Item 1A “Risk Factors”. 102 Components of Operating Results Operating Expenses Our operating expenses since inception have consisted primarily of research and development expenses and general and administrative costs.

For additional information, see Part I, Item 1A “Risk Factors.” Components of Operating Results Operating Expenses Our operating expenses since inception have consisted primarily of research and development expenses and general and administrative costs.

Fair value adjustments on derivative liabilities – contingent value right liability During the year ended December 31, 2024, we recorded $2.0 million of non-cash expense related to fair value adjustments related to the CVRs which were issued in 2024 in connection with the Business Combination and determined to be derivative liabilities.

Fair value adjustments on derivative liabilities – contingent value right liability During the year ended December 31, 2025, we recorded a non-cash expense of approximately $0.2 million as compared to a non-cash expense of approximately $2.0 million from the year ended December 31, 2024, related to fair value adjustments related to the CVRs which were issued in 2024 in connection with the Business Combination and determined to be derivative liabilities.

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