What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2026-02-26 compared with 2025-02-27 · 169 added, 279 removed, 597 unchanged (43% of the section changed)

17 unchanged sentences

Other Information

Entry into At-the-Market Facility

On February 27, 2025, we entered into an Amended and Restated Sales Agreement (the “Amended ATM Agreement”) with Leerink Partners LLC (“Leerink”) and Cantor Fitzgerald & Co.

(“Cantor”) under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million through Leerink and Cantor as sales agents.

The issuance and sale, if any, of common stock under the Amended ATM Agreement will be made pursuant to a registration statement on Form S-3.

The Amended ATM Agreement amends and restates the sales agreement with Leerink and Cantor, dated February 23, 2023, which provided for the offer and sale of up to $200.0 million of our common stock from time to time through Leerink and Cantor as sales agents.

Leerink and Cantor may sell shares of our common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act.

Leerink and Cantor have agreed to use commercially reasonable efforts to sell our common stock from time to time, based on our instructions (including any price, time or size limits or other customary parameters or conditions we may impose).

We will pay Leerink and Cantor a commission equal to three percent (3.0%) of the gross sales proceeds of any common stock sold through Leerink and Cantor under the Amended ATM Agreement.

We provided customary representations, warranties and covenants, and the parties have agreed to customary indemnification rights.

We are not obligated to make any sales of common stock under the Amended ATM Agreement.

The offering of shares of our common stock pursuant to the Amended ATM Agreement will terminate upon the earlier of (i) the sale of the maximum dollar value of common stock permitted to be sold pursuant to the Amended ATM Agreement or (ii) termination of the Amended ATM Agreement in accordance with its terms.

The foregoing description of the Amended ATM Agreement is not complete and is qualified in its entirety by reference to the full text of the Amended ATM Agreement, a copy of which is filed as an exhibit to this Annual Report.

Entry into Employment Agreement with Neal Walker

On February 26, 2025, our board of directors (the “Board”) appointed Neal Walker as our Chief Executive Officer effective immediately.

In connection with such appointment, we have entered into an employment agreement with Dr.

Walker, dated February 26, 2025 (the “Walker Employment Agreement”).

The Walker Employment Agreement has an initial term of two years and thereafter shall be automatically renewed for successive one-year periods unless either party elects not to renew the agreement at least 90 days prior to the expiration of the applicable term.

Walker will receive an annual base salary of $615,000, which may be increased by the Board in its sole discretion.

Walker will be eligible to receive a target annual bonus equal to up to 60% of the annual base salary, subject to the achievement of performance goals to be determined by the Board.

Under the Walker Employment Agreement, if Dr.

Walker’s employment with the Company ends due to his death or “disability”, his resignation for “good reason” or his termination by the Company other than for “cause,” each as defined in the Walker Employment Agreement, in either case that does not occur on or within three months prior to or 12 months after the effective date of a “change of control” (as defined in the Walker Employment Agreement), he will be entitled to receive (i) continuation of his then-current base salary for a period of 12 months;

(ii) any bonuses for the preceding year for which he remains employed through the last day of such year;

and (iii) continued health benefits under COBRA for up to 12 months.

Walker would also receive the foregoing benefits in the event his employment is terminated upon non-renewal of the Walker Employment Agreement by the Company.

In the case Dr.

Walker’s employment with the Company ends due to his death or “disability,” his resignation for “good reason” or his termination by the Company other than for “cause,” in either case that occurs on or within three months prior to or 12 months after the effective date of a “change of control”, then he will be entitled to receive, in addition to the benefits described in the preceding paragraph, (i) continuation of his then-current base salary for an additional six months;

(ii) an additional lump sum payment equal to 150% of his target bonus;

(iii) continued health benefits under COBRA for up to an additional six months;

and (iv) acceleration of all unvested equity awards.

The foregoing benefits are conditioned, among other things, on Dr.

Walker’s compliance with his post-

termination obligations under the Walker Employment Agreement and his execution of a general release of claims in favor of the Company.

Walker has previously entered into our standard form of indemnification agreement.

The foregoing summary of the Walker Employment Agreement is not complete and is qualified in its entirety by reference to the full text of the Walker Employment Agreement, a copy of which is filed as an exhibit to this Annual Report .

Adoption, Modification and Termination of Rule 10b5-1 Plans and Certain Other Trading Arrangements

On December 12, 2024 , Joseph Monahan , our Chief Scientific Officer , adopted a Rule 10b5-1 trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

Sales may commence under the plan on March 13, 2025 and the plan terminates on December 31, 2025 , subject to earlier termination in accordance with its terms.

The aggregate number of securities to be sold under the plan is 60,000 shares of common stock.

No other officers or directors (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408 of Regulation S-K), during the quarter ended December 31, 2024.

During the quarter ended December 31, 2025, n o n e of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408 of Regulation S-K).

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

10 unchanged sentences

Chief Financial Officer

Joseph Monahan, Ph.D.

Roland Kolbeck, Ph.D.

Chief Scientific Officer

Chief Business Officer

Chief Medical Officer

Non-management Directors:

24 unchanged sentences

Davis’s term of office as a director will expire at the 2027 Annual Meeting of Stockholders.

He previously held various roles at Biosion, Inc., a biopharmaceutical company, beginning in March 2020, including as Chief Operating Officer of Biosion Inc., President of Biosion USA, Inc., and, most recently, as Biosion’s Chief Business & Development Officer and President.

Development Officer and President.

Davis has also served as a member of the board of directors of Biosion, Inc.

From 2018 to February 2020, Dr.

since March 2020.

From 2018 to 2020, Dr.

Davis served as Chief Business Officer at Frontage Laboratories, Inc.

1 unchanged sentence

Davis’s previous biopharmaceutical experience includes leadership roles at GlaxoSmithKline and Rhone-Poulenc Rorer.

Davis earned Ph.D.

Davis received Ph.D.

degrees in Biochemistry from Villanova University and a B.S.

11 unchanged sentences

degree from Villanova University.

Joseph Monahan, Ph.D.

Joseph Monahan, Ph.D., has served as our Chief Scientific Officer since January 2021.

From 2017 to January 2021, Dr.

Monahan served as our Executive Vice President, Research and Development.

Monahan founded a biotechnology company, Confluence Life Sciences, Inc., and functioned as its Chief Scientific Officer until our acquisition of Confluence in 2017.

He has also held multiple research leadership positions at Pfizer Inc., including Executive Director, Inflammation Research, global kinase platform leadership team lead;

site head of enzymology and biophysics, and inflammation research and development lead.

He has held adjunct and visiting professor positions at Washington University Medical School, University of Missouri and University of California, Los Angeles School of Medicine.

Monahan received his B.S.

degree in biochemistry from the University of New York at Buffalo and a Ph.D.

degree in biochemistry from the University of South Carolina.

Roland Kolbeck, Ph.D.

Roland Kolbeck, Ph.D., has served as our Chief Scientific Officer since July 2025.

He most recently served as Chief Scientific Officer for Spirovant Sciences from 2020 to April 2025, where he directed the company’s strategy related to new indications, targets, and investments.

Previously, Dr.

Kolbeck was Vice President, Head of Respiratory, Inflammation and Autoimmune Research (RIA) at MedImmune, AstraZeneca’s global biologics organization.

Prior to Medimmune, he served in senior scientific roles at Peptimmune and Millennium Pharmaceuticals.

Kolbeck received his M.S.

degrees at the University of Regensburg and Max Planck Institute for Neurobiology (now the Max Planck Institute for Biological Intelligence), in Munich, Germany.

James Loerop has served as our Chief Business Officer since January 2022.

From July 2019 to January 2022, Mr.

From 2019 to January 2022, Mr.

Loerop served as Executive Vice President, Business Development and Strategic Planning at Anika Therapeutics, Inc., a publicly held company focused on products for joint preservation, where he was responsible for global business development activities.

From 2017 to July 2019, Mr.

From 2017 to 2019, Mr.

Loerop served as Chief Corporate Development Officer for Lupin Pharmaceuticals, Inc., where he was a member of the company’s Executive Leadership Team and was responsible for global business development and corporate development activities.

5 unchanged sentences

degree in marketing from Western Michigan University.

Jesse Hall, M.D.

has served as our Chief Medical Officer since April 2025.

He most recently served as Chief Medical Officer for AltruBio from September 2021 until April 2025.

Prior to AltruBio, from 2018 to April 2021, Dr.

Hall served as Chief Medical Officer and EVP of Scientific and Clinical Affairs at Sublimity Therapeutics.

Prior to Sublimity, Dr.

Hall served as Chief Medical Officer of Aristea Therapeutics, and prior to that in roles of increasing responsibility at companies including Ardea Biosciences (a wholly owned subsidiary of AstraZeneca), Amgen, and Abbott Laboratories.

Hall received a B.A.

degree from the University of San Diego, an M.D.

degree from the University of Oklahoma College of Medicine and conducted his surgical training at the Medical College of Pennsylvania and Hahnemann University.

Non-Management Directors

8 unchanged sentences

He received a B.A.

degree from the College of the

degree from the College of the Holy Cross.

Our Board believes that Mr.

3 unchanged sentences

Gowen’s term of office as a director will expire at the 2026 Annual Meeting of Stockholders.

Gowen previously served as the part-time Chief Executive Officer of TamuroBio Inc., a biotechnology company, from August 2019 to December 2021.

Gowen previously served as the part-time Chief Executive Officer of TamuroBio Inc., a biotechnology company, from 2019 to December 2021.

Gowen founded Trevena, Inc., a publicly held biopharmaceutical company, and served as its President and Chief Executive Officer from 2007 until 2018.

5 unchanged sentences

Gowen held a tenured academic position in the School of Pharmacology, University of Bath, UK from 1989 to 1992.

Gowen currently serves on the boards of directors of the publicly held companies Merus N.V.

and as chair of Passage Bio, Inc.

Gowen currently serves as the chair of the board of directors of the publicly held company Passage Bio, Inc.

Within the past five years, Dr.

Gowen served as a director of the publicly held companies Trevena, Inc., Aceragen, Inc.

Gowen served as a director of the publicly held companies Merus N.V., Trevena, Inc., Aceragen, Inc.

(formerly known as Idera Pharmaceuticals, Inc.) and Akebia Therapeutics, Inc.

13 unchanged sentences

Humphries served as the Chief Executive Officer of lsosceles Pharmaceuticals Inc, a biotechnology company.

From 2018 to December 2020, Mr.

From 2018 to 2020, Mr.

Humphries served as President of Ortho Dermatologics, the dermatology division of Bausch Health Companies, Inc., and previously served as its Executive Vice President, Company Group Chairman for Dermatology and OraPharma from 2017 to 2018.

20 unchanged sentences

Mehra joined Sofinnova Investments, Inc.

(fka Sofinnova Ventures, Inc.), a biotech investment firm, in 2007 and served as a managing general partner until January 2020.

(fka Sofinnova Ventures, Inc.), a biotech investment firm, in 2007 and served as a managing general partner until 2020.

Prior to joining Sofinnova, Dr.

2 unchanged sentences

Mehra was a consultant in McKinsey & Company’s pharmaceutical practice.

Mehra currently serves as the chair of the board of directors of the publicly held company Merus N.V.

Within the past five years, Dr.

Mehra served as the chair of the board of directors of the publicly held company Merus N.V.

Mehra received a B.A.

1 unchanged sentence

degree from Columbia University’s College of Physicians and Surgeons.

Board believes that Dr.

Our Board believes that Dr.

Mehra’s extensive experience in the life sciences industry, his service on the boards of directors of other public life sciences companies and his extensive leadership experience qualify him to serve as a director of our company.

45 unchanged sentences

The Board made a qualitative assessment of Mr.

Milano’s level of knowledge and experience based

on a number of factors, including his formal education and experience as both a chief executive officer and chief financial officer for public reporting companies.

Milano’s level of knowledge and experience based on a number of factors, including his formal education and experience as both a chief executive officer and chief financial officer for public reporting companies.

Insider Trading Policy and Prohibition on Hedging and Pledging

6 unchanged sentences

For the year ended December 31, 2025, our named executive officers (“NEOs”) were:

Interim Chief Executive Officer (1)

Douglas Manion

Former Chief Executive Officer and President (2)

President and Chief Operating Officer (3)

Chief Executive Officer

Kevin Balthaser

Chief Financial Officer

Walker was appointed as our Interim Chief Executive Officer and President effective January 17, 2024, and served as President until November 18, 2024.

In February 2025, he was appointed as our Chief Executive Officer.

Manion stepped down as Chief Executive Officer and President and ceased employment with us effective January 16, 2024.

Davis joined our Company as President and Chief Operating Officer effective November 18, 2024.

Chief Business Officer

Summary Compensation Table

5 unchanged sentences

Neal Walker (3)

Interim Chief Executive Officer

Douglas Manion (5)

Former Chief Executive Officer and President

Hugh Davis (8)

President and Chief Operating Officer

Chief Executive Officer

Kevin Balthaser

Chief Financial Officer

James Loerop (6)

Chief Business Officer

(1) The amounts reflect the full grant date fair value for RSU and stock option awards granted during the indicated year.

The grant date fair value was computed in accordance with ASC Topic 718, Compensation—Stock Compensation .

The assumptions we used in valuing stock options and restricted stock unit awards are described in “Item 8—Notes to Consolidated Financial Statements—Note 7”.

(2) The amounts reflect the portion of each officer’s target annual bonus paid based on the achievement of our corporate and individual goals, as applicable, which for 2024 are discussed further below under “Narrative to Summary Compensation Table—Annual Bonus (Non-Equity Incentive Plan Compensation).”

Walker’s employment with us commenced in January 2024.

The assumptions we used in valuing stock options and RSUs are described in “Item 8—Notes to Consolidated Financial Statements—Note 6”.

(2) The amounts reflect the portion of each officer’s target annual bonus paid based on the achievement of our corporate and individual goals, as applicable, which for 2025 are discussed below under “Narrative to Summary Compensation Table—Annual Bonus (Non-Equity Incentive Plan Compensation).”

Walker’s employment with us commenced in January 2024 as Interim Chief Executive Officer and he was appointed as Chief Executive Officer in February 2025.

(4) The amount consists of fees paid under our director compensation policy for his service as our Chair of the Board prior to Dr.

Walker being appointed as our Interim Chief Executive Officer in January 2024.

Manion’s employment with us ended in January 2024.

(6) The amount consists of (i) $3,115 in company matching contributions to Dr.

Manion’s 401(k) plan account, (ii) the following accrued payments in connection with his separation agreement entered into in February 2024:

(a) $600,000, representing 12 months’ base salary and (b) $198,000, representing 100% of his 2023 target bonus, and (iii) $27,883, representing accrued but unused vacation time paid out upon termination of his employment.

(5) The amount consists of company matching contributions to the executive’s 401(k) plan account.

Davis’s employment with us commenced in November 2024.

Loerop was not one of our named executive officers during the year ended December 31, 2024 and, accordingly, only his compensation for the year ended December 31, 2025 is included in the Summary Compensation Table in accordance with SEC rules.

Narrative to Summary Compensation Table

17 unchanged sentences

In 2025, the Compensation Committee retained Pearl Meyer, a compensation consulting firm, to evaluate and make recommendations with respect to our executive compensation program.

Pearl Meyer’s role included assisting the Compensation Committee with the selection of a peer group of companies for comparison purposes, an analysis of our existing executive compensation, the design of our long-term incentive program, an analysis of our director compensation policy, sharing new developments in areas that fall within the Compensation Committee’s jurisdiction, and otherwise advising the Compensation Committee as appropriate.

The consultant serves at the pleasure of the Compensation Committee, and the consultant’s fees are approved by the

Compensation Committee.

The consultant serves at the pleasure of the Compensation Committee, and the consultant’s fees are approved by the Compensation Committee.

Annual Base Salary

1 unchanged sentence

Annual Base Salary

Douglas Manion

Kevin Balthaser

(1) The increase was related to Dr.

Walker’s appointment as Chief Executive Officer in 2025 from Interim Chief Executive Officer in 2024.

Annual Bonus (Non-Equity Incentive Plan Compensation)

1 unchanged sentence

For 2025, the target bonus for Dr.

Walker was 60% of his base salary and the target bonus for Dr.

Davis and Mr.

Balthaser was 40% of their respective base salaries.

Walker was 60% of his base salary and the target bonus for Mr.

Balthaser and Mr.

Loerop was 40% of their respective base salaries.

The actual annual bonus paid is calculated by multiplying the NEO’s annual base salary, target bonus percentage, the percentage attainment of the corporate goals established by the Board for such year, and for our NEOs other than the Chief Executive Officer, the percentage attainment of the individual goals established by our Chief Executive Officer.

Given his interim role, the Compensation Committee established individual objectives for Dr.

Walker in 2024.

The Compensation Committee is not required to determine bonuses based on this exact formula and reserves the right to consider other factors and adjust bonus amounts accordingly.

For 2024, the bonus funding factor was weighted 75% for corporate goals and 25% for individual goals for all NEOs other than our Chief Executive Officer, whose bonus funding was 100% dependent on the achievement of individual goals.

For 2025, the bonus funding factor was weighted 75% for corporate goals and 25% for individual goals for all NEOs other than our Chief Executive Officer, whose bonus funding was 100% dependent on the achievement of corporate goals.

The Compensation Committee reviews our performance against our goals and approves the extent to which we achieved each of our corporate goals and, with the input of our Chief Executive Officer, individual performance, as applicable, and, for each NEO, the amount of the bonus awarded.

1 unchanged sentence

These goals were divided into two primary categories:

(a) research and development, including advancement of our key assets, cost rationalization, and business development, including financing objectives and strategic planning (90%), and (b) other corporate activities, including legal, finance and compliance objectives (10%).

(a) research and development (75%) and (b) other corporate activities, including business development, financing, and legal, finance and compliance objectives (25%).

The Compensation Committee also approved stretch performance goals in both the research and development and other corporate categories that, if earned, could increase the overall funding of the bonus plan up to a maximum of 140% of the corporate performance target score.

In addition to the corporate performance goals described above, Dr.

Walker evaluated the individual performance of each of Dr.

Davis and Mr.

Balthaser, and recommended a level of achievement to the Compensation Committee, and the Compensation Committee evaluated the individual performance of Dr.

The individual goals for Dr.

Davis and Mr.

Balthaser focused on contributions toward our corporate objectives as well as the personal qualities necessary to effectively manage a team, solve problems and drive our business forward.

Walker evaluated the individual performance of each of Mr.

Balthaser and Mr.

Loerop, and recommended a level of achievement to the Compensation Committee.

The individual goals for Mr.

Balthaser and Mr.

Loerop focused on contributions toward our corporate objectives, personal qualities necessary to effectively manage a team, solve problems and drive our business forward, cross-functional execution to improve processes and productivity, and the promotion of a culture of ethics and compliance.

Walker recommended full credit for these individual objectives, which the Compensation Committee approved.

The individual goals for Dr.

Walker focused on establishing and executing the strategic direction of the Company, as well as securing a permanent Chief Executive Officer.

In early 2026, the Compensation Committee considered each of the 2025 corporate performance goals, as well as individual goals where applicable, and awarded Dr.

Davis and Mr.

Balthaser 130%, 122.5% and 122.5% of their target bonuses, respectively, for the year ended December 31, 2024.

Balthaser and Mr.

Loerop 95%, 96% and 96% of their target bonuses, respectively, for the year ended December 31, 2025.

The actual bonus amounts paid are reflected in the “Non-Equity Incentive Plan Compensation” column of the Summary Compensation Table above.

7 unchanged sentences

The market data that the Compensation Committee reviewed for the purpose of sizing equity grants included long-term incentive awards expressed as a percentage of shares of common stock outstanding, as well as grant date fair values.

As part of his employment as the Interim Chief Executive Officer, in February 2024 the Compensation Committee awarded Dr.

Walker options to purchase 497,000 shares of common stock with an exercise price of $1.20, and 142,000 RSUs, in each case which vest monthly over 15 months commencing March 1, 2024 subject to his continuous service as the Interim Chief Executive Officer to the Company as of each such vesting date, provided that in the event he ceases to be Interim Chief Executive Officer but continues to provide continuous service in any capacity, such awards will continue to vest in the event that the Board determines in its sole discretion that he achieved the individual performance goals as defined in his letter agreement of employment as Interim Chief Executive Officer prior to the cessation of his employment as Interim Chief Executive Officer.

In February 2024, for his annual long-term incentive award, the Compensation Committee awarded Mr.

Balthaser options to purchase 206,500 shares of common stock with an exercise price of $1.20, and 59,000 RSUs, in each case which vest or have vested in four equal installments on February 1, 2025, February 1, 2026, February 1, 2027 and February 1, 2028, subject to his continuous service as of the applicable vesting date.

In addition, also in February 2024, Mr.

Balthaser received a special one-time retention equity grant of 147,500 RSUs, which vests or has vested in two equal installments on December 31, 2024 and December 31, 2025, subject to his continuous service as of the applicable vesting date.

The retention program was designed to retain employees needed to support the Company following the Company’s reduction in force and announcement of the strategic review of its business.

As part of his employment as the President and Chief Operating Officer, in December 2024 the Compensation Committee awarded Dr.

Davis options to purchase 375,000 shares of common stock with an exercise price of $3.96, and 107,000 RSUs, in each case which vest in four equal installments on December 2, 2025, December 2, 2026, December 2, 2027 and December 2, 2028, subject to his continuous service as of the applicable vesting date.

Severance Benefits

In February 2024, in connection with Dr.

Manion’s departure from the Company, we entered into a separation agreement, waiver and release with Dr.

Manion pursuant to which we agreed to provide him the same severance benefits as if he were terminated without cause under his employment agreement as described below under “ Additional Narrative Disclosure—Potential Payments upon Termination of Employment or upon Change in Control—Employment Agreements .”

In accordance with historical practices and the methodology described above, in February 2025 Dr.

Balthaser and Mr.

Loerop were granted an annual equity grant consisting of 253,900, 88,100 and 83,500 restricted stock units, respectively, and stock options to purchase 888,800 shares, 308,200 shares and 292,300 shares, respectively, in each case which vest in four equal installments on the first, second, third and fourth anniversaries of February 3, 2025, subject to the officer’s continuous service as of the applicable vesting date.

In addition, during 2024 certain executives expended considerable effort undertaking a strategic review of our business, the result of which included the licensing of bosakitug and ATI-052 creating a more diversified pipeline of strategic opportunities for the Company across various immunologic and respiratory indications, as well as an extended cash runway achieved through cost rationalization and the closing of a private placement for aggregate gross proceeds of $80.0 million.

To reward such executives for their efforts, in January 2025 Dr.

Balthaser and Mr.

Loerop were granted an equity grant consisting of 88,333, 40,000 and 55,000 restricted stock units, respectively, in each case which 33% of the award vests on January 2, 2025, 33% of the award vests on January 2, 2026 and 34% of the award vests on January 2, 2027, subject to the officer’s continuous service as of the applicable vesting date.

Clawback Policy

In October 2023, in order to comply with SEC rules promulgated under Section 10D-1 of the Exchange Act and Nasdaq listing standards, the Compensation Committee adopted and recommended to the Board the Company’s Incentive Compensation Recoupment Policy, which the Board adopted in November 2023.

Under the Incentive Compensation Recoupment Policy, in the event of an accounting restatement, the Compensation Committee, as the committee of the Board responsible for administering the policy, is authorized to recover certain incentive-based compensation paid to an executive officer of the Company on or after October 2, 2023 to the extent such incentive-based compensation was erroneously paid on the basis of financial results in respect of any of our three most recently completed fiscal years preceding the restatement.

Under our Incentive Compensation Recoupment Policy, in the event of an accounting restatement, the Compensation Committee, as the committee of the Board responsible for administering the policy, is authorized to recover certain incentive-based compensation paid to an executive officer of the Company on or after October 2, 2023 to the extent such incentive-based compensation was erroneously paid on the basis of financial results in respect of any of our three most recently completed fiscal years preceding the restatement.

Additionally, as a public company, if we are required to restate our financial results due to our material noncompliance with any financial reporting requirements under the federal securities laws as a result of misconduct, the Chief Executive Officer and Chief Financial Officer may be legally required to reimburse our Company for any bonus or other incentive-based or equity-based compensation they receive in accordance with the provisions of section 304 of the Sarbanes-Oxley Act of 2002.

1 unchanged sentence

The following table provides information about outstanding equity awards held by each of our NEOs as of December 31, 2025.

Manion did not have any outstanding equity awards as of December 31, 2024.

Option Awards

3 unchanged sentences

Kevin Balthaser

(1) Of the unvested stock options and RSUs, 33,133 and 33,134 stock options vested on January 1, 2025 and February 1, 2025, respectively, and 9,467 RSUs vested on each of January 1, 2025 and February 1, 2025.

The remainder will vest in monthly installments through May 1, 2025, subject to the officer’s continued service through each applicable vesting date.

(2) These unvested stock options and RSUs will vest in four equal installments on December 2, 2025, December 2, 2026, December 2, 2027 and December 2, 2028, subject to the officer’s continued service through each applicable vesting date.

(3) These unvested stock options and RSUs will vest on March 1, 2025, subject to the officer’s continued service through the vesting date.

(4) These unvested stock options and RSUs will vest in two equal installments on March 1, 2025 and March 1, 2026, subject to the officer’s continued service through each appliable vesting date.

(5) Of the unvested stock options and RSUs, one-fourth vested on February 1, 2025 and the remainder will vest in two equal installments on February 1, 2026 and February 1, 2027, subject to the officer’s continued service through each applicable vesting date.

(1) Of the unvested stock options and RSUs, one-fourth vested on February 3, 2026 and the remainder will vest in three equal installments on February 3, 2027, February 3, 2028 and February 3, 2029, subject to the officer’s continued service through each applicable vesting date.

(7) The remainder of the unvested RSUs will vest on December 31, 2025.

(2) Of the total shares underlying this RSU award, 33% vested on January 2, 2025, 33% vested on January 2, 2026 and the remainder will vest on January 2, 2027, subject to the officer’s continued service through the vesting date.

(3) These unvested stock options and RSUs will vest on March 1, 2026, subject to the officer’s continued service through the vesting date.

(4) Of the unvested stock options and RSUs, 50% vested on January 1, 2026 and the remainder will vest on January 1, 2027, subject to the officer’s continued service through the vesting date.

(5) Of the total shares underlying this stock option award and RSU award, one-fourth vested on February 1, 2025, one-fourth vested on February 1, 2026 and the remainder will vest in two equal installments on February 1, 2027 and February 1, 2028, subject to the officer’s continued service through each applicable vesting date.

(6) These unvested stock options and RSUs vested on February 1, 2026.

(7) Of the unvested stock options and RSUs, 50% vested on February 1, 2026 and the remainder will vest on February 1, 2027, subject to the officer’s continued service through the vesting date.

(8) Based on the closing price of our common stock of $3.01 per share on December 31, 2025.

3 unchanged sentences

We have entered into employment agreements with each of Dr.

Davis and Mr.

Balthaser, and had entered into an employment agreement with Dr.

Manion prior to his departure in January 2024.

We entered into a letter agreement with Dr.

Walker in connection with his appointment as our Interim Chief Executive Officer in January 2024 (which is described below).

In connection with his appointment as our Chief Executive Officer, we entered into an employment agreement with Dr.

Walker in February 2025.

Under the employment agreements, each of them is (or, in the case of Dr.

Manion, was) eligible to receive severance benefits in the specified circumstances, as applicable.

Balthaser and Mr.

Under the employment agreements, each of them is eligible to receive severance benefits in the specified circumstances, as applicable.

Severance Upon Qualifying Termination Unrelated to a Change of Control

2 unchanged sentences

● continued payment of then-current base salary for a period of 12 months following termination, in each case payable in accordance with our normal payroll practices;

● a lump-sum payment of any approved but unpaid bonuses or portion thereof for the preceding year or the year of termination for Dr.

Balthaser and Dr.

Manion, and payment of any bonuses for the preceding year for which he remains employed through the last day of such year for Dr.

● a direct payment by the Company to the applicable healthcare provider of the Company’s portion of the medical, vision and dental coverage premiums to maintain any COBRA coverage for which he or she is eligible and has appropriately elected for a period of 12 months following termination.

● a lump-sum payment of any approved but unpaid bonuses or portion thereof for the preceding year or the year of termination for Mr.

Balthaser and Mr.

Loerop, and payment of any bonuses for the preceding year for which he remains employed through the last day of such year for Dr.

● a direct payment by the Company to the applicable healthcare provider of the Company’s portion of the medical, vision and dental coverage premiums to maintain any COBRA coverage for which he is eligible and has appropriately elected for a period of 12 months following termination.

Severance Upon Qualifying Termination Related to a Change of Control

In the event of a Qualifying Termination (other than if the executive’s employment is terminated upon non-renewal by the Company) on or within three months prior to, or within 12 months following, a “Change of Control” (as defined below), each executive would receive the following severance benefits:

● continued payment of then-current base salary for a period of 18 months following termination for Dr.

Manion and Dr.

● continued payment of the then-current base salary for a period of 18 months following termination for Dr.

Walker and for a period of 12 months following termination for each of the other NEOs, payable in accordance with our normal payroll practices;

● a lump-sum payment of any approved but unpaid bonuses or portion thereof for the preceding year or the year of termination for Dr.

Balthaser and Dr.

Manion, and payment of any bonuses for the preceding year for which he remains employed through the last day of such year for Dr.

● a lump-sum payment of any approved but unpaid bonuses or portion thereof for the preceding year or the year of termination for Mr.

Balthaser and Mr.

Loerop, and payment of any bonuses for the preceding year for which he remains employed through the last day of such year for Dr.

● an additional lump sum payment equal to 150% of the target bonus for Dr.

Manion and Dr.

Walker and 100% of the target bonus for each of the other NEOs;

1 unchanged sentence

and has appropriately elected for a period of 18 months following termination for Dr.

Manion and Dr.

Walker and for a period of 12 months following termination for each of the other NEOs;

3 unchanged sentences

(i) his conviction of, or guilty plea to, a felony, other than traffic violations;

(ii) any act or omission by him or her which constitutes gross negligence or a material breach of his duty of loyalty;

(iii) any material breach by him or her of our personnel policies;

(ii) any act or omission by him which constitutes gross negligence or a material breach of his duty of loyalty;

(iii) any material breach by him of our personnel policies;

(iv) refusal to follow or implement a clear and reasonable directive;

(v) breach of fiduciary duty;

or (vi) a material violation or breach by him or her of his employment agreement, other than an event described in the foregoing clauses, or any other agreement with us;

or (vi) a material violation or breach by him of his employment agreement, other than an event described in the foregoing clauses, or any other agreement with us;

● “Good Reason” means, in the absence of events that would support a termination for cause:

1 unchanged sentence

(ii) his annual base salary is materially decreased without his prior written consent;

(iii) he or she is assigned duties materially inconsistent with his title and the responsibilities set forth in his job description without his prior written consent;

(iii) he is assigned duties materially inconsistent with his title and the responsibilities set forth in his job description without his prior written consent;

(iv) his place of employment is changed to a location that is greater than 50 miles from his current place of employment (disregarding for this purpose any remote work arrangements);

or (v) any other material violation or breach by us of his employment agreement;

provided, however, none of the above events will constitute good reason absent him or her providing us with proper notice and our failure to cure such event within 30 days of such notice;

provided, however, none of the above events will constitute good reason absent him providing us with proper notice and our failure to cure such event within 30 days of such notice;

● “Change of Control” means:

5 unchanged sentences

and, provided further, that such “Change of Control” qualifies as either a change in ownership of the Company as defined in Section 409A of the Code (“Section 409A”) or a change in the ownership of a substantial portion of our assets as defined in Section 409A, as the case may be.

Letter Agreement with Dr.

In January 2024, in connection with his appointment as Interim Chief Executive Officer, we entered into a letter agreement with Dr.

Walker setting forth the terms of his employment.

As described above under “Narrative to Summary Compensation Table—Long-Term Incentives”, Dr.

Walker was granted equity awards in connection with his appointment.

The equity awards will accelerate vesting and exercisability in full upon a Change in Control (as defined in the Company’s 2015 Equity Incentive Plan (“2015 Plan”)).

Separation Agreement with Dr.

As described above, in January 2024, Dr.

Manion departed the Company following which we entered into a separation agreement, waiver and release with Dr.

Manion pursuant to which we agreed to provide him the same severance benefits as if he were terminated without cause unrelated to a Change of Control under his employment agreement.

We maintain a tax-qualified retirement plan (our 401(k) plan) that provides eligible U.S.

8 unchanged sentences

The policy applies to each of our directors who is not an employee of our company.

During 2024, Dr.

Manion and Dr.

Davis, as employees of our Company, did not receive any additional compensation for service as a director.

Effective January 17, 2024, Dr.

Walker was appointed as our Interim Chief Executive Officer and stopped receiving additional compensation for service as a director.

Pursuant to the policy in effect for 2025, each non-employee director received an annual cash retainer of $40,000 for serving on our Board.

The Chair of the Board received an additional annual cash retainer of $30,000 and the Lead Independent Director received an additional annual cash retainer of $25,000.

The members of each of the Audit, Compensation, Nominating and Corporate Governance and Research and Development Committees received additional retainers for such service, as did the Chair of each such committee (in addition to the member retainers), as follows:

The Lead Independent Director received an additional annual cash retainer of $25,000.

The members of each of the Audit, Compensation and Nominating and Corporate Governance Committees received additional retainers for such service, as did the Chair of each such committee (in addition to the member retainers), as follows:

Annual Service

3 unchanged sentences

Nominating and Corporate Governance Committee

Research and Development Committee (1)

(1) Effective December 31, 2024, the Research and Development Committee was dissolved.

All annual cash compensation amounts were payable in equal quarterly installments in arrears, on the last day of each fiscal quarter for which the service occurred, prorated based on the days served in the applicable fiscal quarter.

2 unchanged sentences

Once the aggregate fair value of the new director award has been determined, the new director will be granted a stock option having a grant date fair value equal to 70% of such amount and RSUs having a grant date fair value equal to 30% of such amount.

The shares subject to each stock option granted will vest in 36 equal monthly installments on the monthly anniversary of the grant date and the RSUs will vest in three equal installments on the first, second and third anniversary of the grant date, subject to continued service through the applicable vesting date.

The exercise price per share of each stock option will be equal to the closing price of our common stock on the date of the option grant.

Each such stock option will have a term of ten years from the date of grant, subject to earlier termination in connection with a termination of the non-employee director’s continuous service with us.

On the date of each annual meeting of our stockholders, each non-employee director who continues to serve as a director of our company following the meeting will be granted awards under our 2025 Plan with an aggregate grant date fair value (as calculated for financial reporting purposes) equal to the lesser of (a) $320,000 or (b) the fair value of 60,500 stock options measured as of the annual meeting date.

Once the aggregate fair value of the continuing director award has been determined, the continuing director will be granted a stock option having a grant date fair value equal to 70% of such amount and RSUs having a grant date fair value equal to 30% of such amount.

In no event, however, shall the fair value of the annual award, together with the fair value of any initial award granted to a new director who joined the Board in the same fiscal year, exceed $320,000 in the aggregate.

The shares subject to each stock option granted will vest in equal monthly installments over 12 months and the RSUs will vest in one installment on the first anniversary of the grant date, subject to continued service through the applicable vesting date.

The exercise price per share of each stock option will be equal to the closing price of our common stock on the date of the option grant.

The exercise price per share

of each stock option will be equal to the closing price of our common stock on the date of the option grant.

On June 6, 2024, the date of our 2024 annual meeting of stockholders, each non-employee director then serving on our Board (other than Dr.

Walker) who continued to serve as a director of our company following the meeting was granted a stock option to purchase 15,750 shares of common stock and 4,793 RSUs under our 2015 Plan.

The sum of any cash or other compensation and the value (based on the grant date fair value) of awards granted to any non-employee director for services as a director during any fiscal year may not exceed $750,000.

On June 5, 2025, the date of our 2025 annual meeting of stockholders, each non-employee director then serving on our Board was granted a stock option to purchase 42,350 shares of common stock and 11,580 RSUs under our 2025 Plan.

These awards are reflected in the table below.

1 unchanged sentence

The following table shows the compensation earned by each of our non-employee directors for 2025.

During 2024, Dr.

Manion and Dr.

Davis, as employees of our Company, did not receive any additional compensation for service as a director.

Effective January 17, 2024, Dr.

Walker was appointed as our Interim Chief Executive Officer and stopped receiving additional compensation for service as a director.

Manion’s, Dr.

Davis’ and Dr.

Walker, our Chief Executive Officer, and Dr.

Davis, our President and Chief Operating Officer, is also a director but did not receive any additional compensation for his service as a director in 2025.

Walker’s compensation as an executive officer is set forth above under “Summary Compensation Table.”

Fees Earned or Paid

Fees Earned or Paid in Cash

Option Awards

4 unchanged sentences

Christopher Molineaux

Andrew Powell (5)

Bryan Reasons (6)

Andrew Schiff, M.D.

6 unchanged sentences

Mehra, 105,175 stock options and 11,580 RSUs;

84,401 stock options and 4,793 RSUs;

Molineaux, 106,066 stock options and 11,580 RSUs;

Schiff, 121,175 stock options and 11,580 RSUs;

3 unchanged sentences

The RSUs will vest on June 5, 2026, subject to continuous service with us through that date.

(4) Consists of an option granted on June 6, 2024 to purchase 15,750 shares a t an exercise price of $1.03 per share.

(4) Consists of an option granted on June 5, 2025 to purchase 42,350 shares at an exercise price of $1.56 per share.

This option vests in 12 equal monthly installments through June 5, 2026, subject to continuous service with us through each vesting date.

Powell resigned effective as of the 2024 annual meeting and therefore did not receive an annual equity award.

Reasons did not stand for re-election at the 2024 annual meeting when his term expired and therefore did not receive an annual equity award.

Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information

2 unchanged sentences

We typically grant annual refresh employee option grants in the first quarter of each fiscal year, which refresh grants are typically approved at a regularly scheduled meeting of the Compensation Committee occurring in such quarter.

In addition, non-employee directors receive automatic grants of initial and annual stock option awards, at the time of a director’s initial appointment or election to the board and at the time of each annual meeting of our stockholders, respectively, pursuant to our non-employee director compensation policy, as further described under the heading, “Non-Employee Director Compensation”.

Compensation”.

We do not otherwise maintain any written policies on the timing of awards of stock options, stock appreciation rights, or similar instruments with option-like features.

1 unchanged sentence

We have not timed the release of MNPI for the purpose of affecting the value of executive compensation.

The following table is being provided pursuant to Item 402(x)(2) of Regulation S-K.

underlying the

Exercise price of the

Grant date fair

Percentage change in the

closing market price of the

securities underlying the

award between the trading

day ending immediately prior

to the disclosure of material

nonpublic information and the

trading day beginning

immediately following the

disclosure of material

nonpublic information

February 1, 2024

Kevin Balthaser

February 1, 2024

(1) The option grants reported in this table were made two business days before the Company filed (i) a Form 8-K under Item 5.02 reporting the departure of our Chief Medical Officer, the entry into an amended and restated employment agreement with our Chief Scientific Officer, and the entry into a separation agreement with our former Chief Executive Officer and President following his previously reported departure and (ii) a Form 8-K amendment under Item 5.02 reporting the entry into a compensatory letter agreement with Dr.

Walker following his previously reported appointment as our Interim Chief Executive Officer.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

9 unchanged sentences

Biosion, Inc.

Adage Capital Management, L.P.

Entities associated with Vivo Capital LLC (4)

Rock Springs Capital Management LP (6)

BlackRock, Inc.

The Vanguard Group (6)

Named Executive Officers and Directors:

Neal Walker (7)

Douglas Manion (8)

Kevin Balthaser (8)

James Loerop (9)

Hugh Davis (10)

William Humphries (11)

15 unchanged sentences

The principal business address of BML is 65 E Cedar, Suite 2, Zionsville, IN 46077.

(3) This information has been obtained from a Schedule 13G filed on November 25, 2024 by Biosion.

The number represents 11,281,985 shares of common stock issuable to Biosion upon exercise of a warrant held by it.

The principal business address of Biosion is 5th Floor, Building D, 3-1 Zhongdan Unit, South Longshan Rd, Jiangbei New District, Nanjing, Jiangsu, China.

(4) This information has been obtained from a Schedule 13G filed on February 12, 2025 by Adage Capital Management, L.P.

(“ACM”), Robert Atchinson, and Phillip Gross, which states that the shares are directly held by Adage Capital Partners, L.P.

(“ACP”), of which ACM is the investment manager.

Atchinson is (a)

managing member of Adage Capital Advisors, L.L.C.

(“ACA”), the managing member of Adage Capital Partners GP, L.L.C., (“ACPGP”), the general partner of ACP and (b) managing member of Adage Capital Partners LLC, (“ACPLLC”), general partner of ACM.

Gross is (a) managing member of ACA, managing member of ACPGP and (b) managing member of ACPLLC.

The principal business address of this entity and persons is 200 Clarendon Street, 52nd Floor, Boston, Massachusetts 02116.

(3) This information has been obtained from a Schedule 13G/A filed on January 9, 2026 by Biosion, Inc.

and Bonita Biotech (HK) Ltd.

The principal business address of these entities is 5th Floor, Building D, 3-1 Zhongdan Unit, South Longshan Rd, Jiangbei New District, Nanjing, Jiangsu, China.

(4) This information has been obtained from a Schedule 13G filed on November 21, 2024 by Vivo Opportunity Fund Holdings, L.P.

2 unchanged sentences

Consists of (a) 7,955,160 shares of common stock held by Opportunity Fund and (b) 933,728 shares of common stock held by Asia Opportunity Fund.

Vivo Opportunity, LLC is the general partner of Opportunity Fund.

Opportunity, LLC is the general partner of Opportunity Fund.

Vivo Opportunity Cayman, LLC is the general partner of Asia Opportunity Fund.

1 unchanged sentence

The principal business address of these entities and persons is 192 Lytton Avenue, Palo Alto, California 94301.

(6) This information has been obtained from a Schedule 13G filed on November 22, 2024 by Rock Springs Capital Management LP, Rock Springs Capital LLC, its general partner, and Rock Springs Capital Master Fund LP, which states that 5,697,000 shares are held directly by Rock Springs Capital Master Fund LP and 1,064,861 shares are held directly by Four Pines Master Fund LP.

Rock Springs Capital Management LP serves as the investment manager to each of Rock Springs Capital Master Fund LP and Four Pines Master Fund LP.

The principal business address of Rock Springs Capital Management LP and Rock Springs Capital LLC is 650 South Exeter St., Suite 1070, Baltimore, MD 21202.

The principal business address of Rock Springs Capital Master Fund is c/o Walkers Corporate Limited, 190 Elgin Avenue, George Town, Grand Cayman, KY1-9008, Cayman Islands.

(7) Consists of (a) 1,460,718 shares of common stock, (b) 1,724,472 shares of common stock underlying options that are exercisable within 60 days of February 10, 2025 and (c) 18,933 shares of common stock underlying RSUs that will vest within 60 days of February 10, 2025.

(8) Consists of 41,813 shares of common stock.

(5) This information has been obtained from a Schedule 13G/A filed on January 21, 2026 by BlackRock, Inc.

Various persons have the right to receive or the power to direct the receipt of dividends from, or the proceeds from the sale of these shares.

The principal business address of BlackRock, Inc.

is 50 Hudson Yards, New York, NY 10001.

(6) This information has been obtained from a Schedule 13G filed on July 29, 2025 by The Vanguard Group.

The Vanguard Group’s clients, including investment companies registered under the Investment Company Act of 1940 and other managed accounts, have the right to receive or the power to direct the receipt of dividends from, or the proceeds from the sale of, these shares.

The principal business address of The Vanguard Group is 100 Vanguard Blvd., Malvern, PA 19355.

(7) Consists of (a) 1,543,886 shares of common stock and (b) 1,631,452 shares of common stock underlying options that are exercisable within 60 days of February 9, 2026.

(8) Consists of (a) 185,755 shares of common stock, (b) 321,250 shares of common stock underlying options that are exercisable within 60 days of February 9, 2026 and (c) 2,375 shares of common stock underlying RSUs that will vest within 60 days of February 9, 2026.

2 unchanged sentences

(11) Consists of (a) 33,525 shares of common stock and (b) 137,291 shares of common stock underlying options that are exercisable within 60 days of February 9, 2026.

(12) Consists of (a) 57,956 shares of common stock and (b) 117,423 shares of common stock underlying options that are exercisable within 60 days of February 9, 2026.

(13) Consists of (a) 714,823 shares of common stock and (b) 119,291 shares of common stock underlying options that are exercisable within 60 days of February 9, 2026.

(14) Consists of (a) 434,455 shares of common stock owned directly by Aisling Capital IV, LP (“Aisling”), (b) 13,960 shares of common stock owned directly by Dr.

23 unchanged sentences

Equity compensation plans approved by security holders:

2012 Equity Compensation Plan (1)

2015 Equity Incentive Plan (1)

2025 Equity Incentive Plan

Equity compensation plans not approved by security holders:

2 unchanged sentences

(1) No additional further options or awards may be granted under the 2015 Equity Compensation Plan.

(2) Weighted average exercise price for the 2015 Plan gives effect to outstanding restricted stock units, which have no exercise price.

Excluding the restricted stock units, the weighted average exercise price would be $11.15 per share.

(3) On January 1 of each year ended with January 1, 2025, the number of shares reserved under the 2015 Plan automatically increased by 4% of the total number of shares of common stock that were outstanding at that time, or a lesser number of shares as determined by our Board.

Pursuant to the terms of the 2015 Plan, an additional 4,314,004 shares were added to the number of available shares reflected in the table effective January 1, 2025.

(4) Our Board adopted the 2017 Inducement Plan, which is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules.

All shares of common stock that were eligible for issuance under the 2017 Inducement Plan after October 1, 2018, including any shares underlying any awards that expire or are otherwise terminated, reacquired to satisfy tax withholding obligations, settled in cash or repurchased by the Company in the future that would have been eligible for re-issuance under the 2017 Inducement Plan, were retired.

No additional further options or awards may be granted under the 2017 Inducement Plan;

all outstanding stock awards will continue to be governed by their existing terms.

(2) Weighted average exercise price for the 2015 Plan gives effect to outstanding RSUs, which have no exercise price.

Excluding the RSUs, the weighted average exercise price would be $7.18 per share.

(3) Weighted average exercise price for the 2025 Plan gives effect to outstanding RSUs, which have no exercise price.

Excluding the RSUs, the weighted average exercise price would be $1.77 per share.

(4) For a description of the material terms of this plan, see “Item 8—Notes to Consolidated Financial Statements—Note 6—2017 Inducement Plan.”

(5) For a description of the material terms of this plan, see “Item 8—Notes to Consolidated Financial Statements—Note 6—2024 Inducement Plan.”

(6) Weighted average exercise price for the 2024 Inducement Plan gives effect to outstanding RSUs, which have no exercise price.

7 unchanged sentences

Under the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, our management must present information regarding the related person transaction to our Audit Committee, or, if Audit Committee approval would be inappropriate, to another independent body of our Board, for review, consideration and approval or ratification.

The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from as the case may be, an unrelated third party or to or from employees generally.

The presentation must include a

description of, among other things, the material facts, the interests, direct and indirect, of the related persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from as the case may be, an unrelated third party or to or from employees generally.

Under the policy, we collect information that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant stockholder to enable us to identify any existing or potential related person transactions and to effectuate the terms of the policy.

15 unchanged sentences

As required under the Nasdaq Stock Market (“Nasdaq”) listing standards, a majority of the members of a listed company’s board of directors must qualify as “independent,” as affirmatively determined by the Board.

The Board consults with the Company’s counsel to ensure that the Board’s determinations are consistent with relevant securities and other laws and regulations regarding the definition of “independent,” including those set forth in pertinent listing standards of Nasdaq, as in effect from time to time.

Nasdaq, as in effect from time to time.

Consistent with these considerations, after review of all relevant identified transactions or relationships between each director, or any of his or her family members, and our company, senior management and independent auditors, the Board has affirmatively determined that six of our eight current directors are independent directors within the meaning of the applicable Nasdaq listing standards:

2 unchanged sentences

Gowen and Mr.

In addition, the Board also affirmatively determined that Andrew Powell and Byran Reasons, who served on the Board during a part of 2024, were also independent directors within the meaning of the applicable Nasdaq listing standards.

In making these determinations, the Board found that none of these directors had a material or other disqualifying relationship with our company.

24 unchanged sentences

001-37581), filed with the SEC on October 13, 2015).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37581), filed with the SEC on August 7, 2023).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37581), filed with the SEC on June 5, 2025).

Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

1 unchanged sentence

Description of Securities.

(incorporated by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2024).

Amended and Restated 2012 Equity Compensation Plan (incorporated by reference to Exhibit 10.7 to Amendment No.

1 to the Registrant’s Registration Statement on Form S-1 (File No.

333-206437), filed with the SEC on September 4, 2015).

Form of Stock Option Grant under Amended and Restated 2012 Equity Compensation Plan (incorporated by reference to Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1 (File No.

333-206437), filed with the SEC on August 17, 2015).

2015 Equity Incentive Plan (incorporated by reference to Exhibit 4.6 to the Registrant’s Registration Statement on Form S-8 (File No.

6 unchanged sentences

333-206437), filed with the SEC on September 25, 2015).

Form of Performance Stock Option Grant Notice and Stock Option Agreement used in connection with the 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.11 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on March 18, 2019).

Form of Performance Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement used in connection with the 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.12 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on March 18, 2019).

2017 Inducement Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

8 unchanged sentences

001-37581), filed with the SEC on November 18, 2024).

Ninth Amended and Restated Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q (File No.

2025 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37581), filed with the SEC on June 5, 2025).

Form of Stock Option Grant Notice and Option Agreement used in connection with the Aclaris Therapeutics, Inc.

2025 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37581), filed with the SEC on June 5, 2025).

Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement used in connection with the Aclaris Therapeutics, Inc.

2025 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.

001-37581), filed with the SEC on June 5, 2025).

Tenth Amended and Restated Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37581), filed with the SEC on May 8, 2025).

1 unchanged sentence

333-206437), filed with the SEC on August 17, 2015).

Second Amended and Restated Employment Agreement, effective as of February 1, 2024, by and between the Registrant and Joseph Monahan (incorporated herein by reference to Exhibit 10.15 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2024).

Employment Agreement, dated as of April 28, 2025, by and between the Registrant and Jesse Hall (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37581), filed with the SEC on May 8, 2025).

Employment Agreement, dated as of January 31, 2022, by and between the Registrant and James Loerop (incorporated herein by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 24, 2022).

Separation Agreement, Waiver, and Release, dated as of February 4, 2024, by and between the Registrant and Douglas Manion (incorporated herein by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2024).

Employment Agreement, effective as of July 28, 2025, by and between the Registrant and Roland Kolbeck (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37581), filed with the SEC on November 6, 2025).

Employment Agreement, dated as of January 1, 2023, by and between the Registrant and Kevin Balthaser (incorporated herein by reference to Exhibit 10.24 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 23, 2023).

Amended and Restated Employment Agreement, dated as of January 1, 2023, by and between the Registrant and Douglas Manion (incorporated herein by reference to Exhibit 10.23 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 23, 2023).

Letter Agreement, dated as of January 31, 2024, by and between the Registrant and Neal Walker (incorporated herein by reference to Exhibit 10.22 to the Registrant’s Annual Report on Form 10-K (File No.

Employment Agreement, dated as of February 26, 2025, by and between the Registrant and Neal Walker (incorporated herein by reference to Exhibit 10.21 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2025 ).

Employment Agreement, dated as of February 26, 2025, by and between the Registrant and Neal Walker.

Employment Agreement, dated as of November 18, 2024, by and between the Registrant and Hugh Davis (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.

2 unchanged sentences

001-37581), filed with the SEC on June 1, 2023).

Amended and Restated Sales Agreement, dated February 27, 2025, by and among the Registrant, Leerink Partners LLC and Cantor Fitzgerald & Co.

Royalty Purchase Agreement, effective as of July 16, 2024, by and between the Registrant and OCM IP Healthcare Portfolio LP (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37581), filed with the SEC on August 7, 2024).

Amended and Restated Sales Agreement, dated February 27, 2025, by and among the Registrant, Leerink Partners LLC and Cantor Fitzgerald & Co.

(incorporated herein by reference to Exhibit 10.24 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2025).

Exclusive License Agreement, dated as of November 18, 2024, by and between the Registrant and Biosion, Inc.

(incorporated herein by reference to Exhibit 10.26 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2025).

Collaboration Agreement, dated as of November 18, 2024, by and among the Registrant, Biosion, Inc.

and Chia Tai Tianqing Pharmaceutical Group, Co., Ltd.

Form of Common Stock Purchase Warrant Agreement issued on November 18, 2024.

Form of Securities Purchase Agreement, dated November 18, 2024, by and between the Registrant and the investors named therein (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37581), filed with the SEC on November 18, 2024).

Form of Registration Rights Agreement, dated November 18, 2024, by and between the Registrant and the investors named therein (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37581), filed with the SEC on November 18, 2024).

Insider Trading Policy, effective as of February 26, 2025.

(incorporated herein by reference to Exhibit 10.27 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2025).

Form of Common Stock Purchase Warrant Agreement issued on November 18, 2024 (incorporated herein by reference to Exhibit 10.28 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2025).

Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2025).

Subsidiaries of the Registrant (incorporated herein by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K (File No.

6 unchanged sentences

Section 1350, as adopted pursuant to section 906 of The Sarbanes-Oxley Act of 2002.

Aclaris Therapeutics, Inc.

Incentive Compensation Recoupment Policy, adopted as of October 2, 2023 (incorporated herein by reference to Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K (File No.

Incentive Compensation Recoupment Policy (incorporated herein by reference to Exhibit 97.1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37581), filed with the SEC on February 27, 2024).

8 unchanged sentences

This certification is being furnished solely to accompany this Annual Report pursuant to 18 U.S.C.

Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be

incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Indicates management contract or compensatory plan.

44 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures