Quince Therapeutics becomes IRulya, names new CEO

The company reported a $116 million cash balance as of June 30, 2026, which it expects to fund operations through the end of 2028.

Rhea-AI Filing Summary

Quince Therapeutics, Inc. changed its name to IRulya Therapeutics Inc. effective October 9, 2026. Its common stock is expected to begin trading as IRLA on the Nasdaq Capital Market on October 12, moving from the Nasdaq Global Select Market.

Effective October 8, 2026, Brigette Roberts, M.D., became CEO, John Militello, CPA, CFO, and Keith Fandrick COO. Dirk Thye resigned as CEO, Chief Medical Officer and director, and Brendan Hannah resigned as COO, Chief Business Officer and Chief Compliance Officer. Catherine M. Bonuccelli, Leone Patterson, James Valentine and Drayton Wise joined the board; June Bray, David Lamond and Christopher Senner also resigned from the board.

IRulya is focused on LAM-001, an inhaled rapamycin formulation for BOS, PH-ILD and SAPH. Phase 2 studies in BOS and PH-ILD are ongoing; a Phase 2 study in SAPH is anticipated in the fourth quarter of 2026. The company reported a cash balance of $116 million as of June 30, 2026, and expects it to fund operations through the end of 2028. Series C preferred stock will automatically convert effective October 9, 2026, at 5:00 p.m. ET, subject to holder-specific beneficial ownership limitations; the company expects approximately 10,841,470 common shares outstanding following conversion.

Filing Explained

Stockholders approved issuance of common shares upon Series C preferred conversion and exercise of transaction warrants and assumed legacy Orphai options; approval is not issuance, but any resulting additional shares would reduce existing holders’ percentage ownership.

8-K Event Classification

5 items: 5.02, 5.03, 7.01, 8.01, 9.01

5 items

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers Governance

Key personnel changes including departures, elections, or appointments of directors and executive officers.

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year Governance

The company amended its charter documents, bylaws, or changed its fiscal year.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Cash balance: $116 million Expected common shares outstanding after conversion: Approximately 10,841,470 shares CEO annual base salary: $600,000 +4 more

7 metrics

Cash balance $116 million As of June 30, 2026

Expected common shares outstanding after conversion Approximately 10,841,470 shares Following conversion of Series C preferred stock

CEO annual base salary $600,000 Brigette Roberts

CEO target annual bonus 50% of base salary Brigette Roberts

CFO annual base salary $440,000 John Militello

Restricted stock unit award 80,000 shares John Militello; subject to Board approval

COO annual base salary $450,000 Keith Fandrick

Key Terms

LAM-001, mTOR inhibitor, BOS, PH-ILD, +2 more

6 terms

LAM-001 medical

"LAM-001, an investigational formulation of inhaled rapamycin"

mTOR inhibitor medical

"inhaled rapamycin (mTOR inhibitor)"

mTOR inhibitors are drugs that block the mTOR protein, a cell-signaling “traffic light” that tells cells when to grow, divide or produce energy. They matter to investors because these drugs can treat cancers, immune disorders and other conditions, so clinical results, safety and regulatory approvals can dramatically affect a biotech’s future revenue and valuation much like a new product changing a company’s market prospects.

BOS medical

"bronchiolitis obliterans syndrome post lung transplant (BOS)"

PH-ILD medical

"pulmonary hypertension associated with interstitial lung disease (PH-ILD)"

PH-ILD stands for pulmonary hypertension associated with interstitial lung disease, a condition where stiff or scarred lung tissue makes it harder to move oxygen into the blood and causes dangerously high blood pressure in the lung arteries. Investors care because it signals a serious, progressive illness with limited treatment options, shaping demand for therapies, clinical trial design, regulatory review and long-term revenue potential in respiratory and cardiovascular drug markets.

SAPH medical

"sarcoidosis associated pulmonary hypertension (SAPH)"

beneficial ownership limitations financial

"subject to certain beneficial ownership limitations set by each holder"

Beneficial ownership limitations are rules or contractual caps that restrict how much of a company’s stock an individual or entity can be treated as owning or controlling for legal, regulatory or corporate-governance purposes. They matter to investors because such limits affect voting power, reporting obligations, takeover risk and the ability to increase a stake — like an elevator weight limit or a lane divider that prevents any one car from taking over the whole road.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is QNCX CEO Brigette Roberts' compensation?

Brigette Roberts, M.D., will receive an annual base salary of $600,000 and a target annual bonus of 50% of her base salary.

What stock award is QNCX CFO John Militello eligible to receive?

John Militello is entitled to receive, subject to Board approval, a restricted stock unit award covering 80,000 shares. It will vest over four years, with 25% vesting on July 6, 2027, and 6.25% vesting at the end of each calendar quarter thereafter.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 7, 2026

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38890		90-1024039
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

611 Gateway Boulevard, Suite 273
South San Francisco, California		94080
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (415) 910-5717

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		QNCX		Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Resignation of Officers

As previously announced, effective as of October 8, 2026, Dirk Thye, M.D., resigned as Chief Executive Officer and Chief Medical Officer, as well as a director, of Quince Therapeutics, Inc., which will be renamed IRulya Therapeutics Inc. effective at 4:01 p.m., Eastern Time, on October 9, 2026 (the “Company”), and Brendan Hannah resigned as Chief Operating Officer, Chief Business Officer and Chief Compliance Officer of the Company.

Appointment of Chief Executive Officer

Effective October 8, 2026 (the “Effective Date”), the Board of Directors (the “Board”) of the Company appointed Brigette Roberts, M.D., as Chief Executive Officer of the Company.

Brigette Roberts, M.D., age 50

Dr. Roberts has served as the Company’s Chief Corporate Affairs Officer and member of the Board since May 2026. Prior to that, she served as the Chief Executive Officer and member of the Board of Directors of Orphai Therapeutics, Inc. (“Orphai”) from May 2021 until May 2026, and prior to that she served as the Chief Medical Officer of Orphai from February 2021 until May 2021. During her time at Orphai, Dr. Roberts built a differentiated pulmonary franchise centered on LAM-001, an inhaled formulation of rapamycin for pulmonary vascular and fibrotic lung diseases, initiated two Phase 2 studies of LAM-001, secured United States and European Union orphan drug designations for LAM-001 across multiple indications and raised more than $45 million in new private investment. Prior to Orphai, Dr. Roberts served as an Entrepreneur in Residence at Fortress Biotech from 2017 to January 2021 where she identified new assets to spin into new biotechnology companies. Prior to that, Dr. Roberts spent over 15 years as a healthcare investor and portfolio manager including at CDP Capital, Angel Lane Principal Strategies, YYC Capital (which she founded), Third Point, LLC and DKR Capital. Dr. Roberts also served as a director of Ligand Pharmaceuticals from December 2005 to February 2007. Dr. Roberts holds a B.A. in Physics and Chemistry from Harvard University and an M.D. from New York University.

Pursuant to the terms of that certain employment letter, dated as of May 18, 2026, between the Company and Dr. Roberts (the “Roberts Employment Agreement”), which provides that the terms of her employment letter, dated as of May 12, 2026, by and between Orphai and Dr. Roberts (the “Roberts Orphai Employment Agreement”) would remain generally unchanged, Dr. Roberts will receive an annual base salary of $600,000 and a target annual bonus of 50% of her base salary.

Pursuant to the terms of that certain severance agreement, dated as of March 3, 2025, between Orphai and Dr. Roberts (the “Roberts Orphai Severance Agreement”), upon a termination by the Company without Cause (as defined in the Roberts Orphai Severance Agreement), Dr. Roberts will be entitled to (i) continued payments equal to her then-current base salary for a period of twelve months following termination, (ii) a lump-sum payment in an amount equal to twelve months of COBRA premiums, and (iii) acceleration of vesting of all outstanding time-based equity awards by twelve months. In addition, as of the termination date, all vested incentive-stock options shall convert to non-qualified stock options, exercisable up to the one-year anniversary date of termination; provided that no option shall have its term extended beyond the original expiration date set forth in the applicable option grant notice. Receipt of the foregoing severance benefits is conditioned on Dr. Robert’s execution of a general release of claims in favor of the Company.

In connection with Dr. Roberts’ appointment as Chief Executive Officer, the Board determined that Dr. Roberts will succeed Mr. Thye as the Company’s principal executive officer, effective as of the Effective Date.

The foregoing descriptions of the Roberts Employment Agreement, Roberts Orphai Employment Agreement and Roberts Orphai Severance Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Roberts Employment Agreement, Roberts Orphai Employment Agreement and Roberts Orphai Severance Agreement. Copies of the Roberts Employment Agreement and the Roberts Orphai Employment Agreement were previously filed as Exhibit 10.3 and 10.4 to the Company’s Current Report on Form 8-K filed the Securities and Exchange Commission on May 18, 2026 and incorporated herein by reference. A copy of the Roberts Orphai Severance Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

Appointment of Chief Financial Officer

Effective as of the Effective Date, John Militello, CPA, was appointed as Chief Financial Officer of the Company.

John Militello, CPA, age 53

John Militello, CPA, has served as Head of Finance of Orphai Therapeutics, LLC since July 2026. Before joining the Company, Mr. Militello served as VP of Finance, Sr. Controller, Treasurer and Principal Accounting Officer of Rocket Pharmaceuticals, Inc., a publicly traded gene therapy company, from January 2018 to July 2026. Mr. Militello was also the Interim Principal Financial Officer of Rocket Pharmaceuticals from January 2018 to December 2020 and March 2022 to March 2024. Previously, Mr. Militello served as the Vice President of Finance and Principal Financial and Accounting Officer at Immune Pharmaceuticals Inc. from April 2015 to November 2017. Prior to that, Mr. Militello was an Assistant Controller at Travere Therapeutics, formerly Retrophin, Inc., a publicly traded biotechnology company, and a Senior Manager in the biotech practice of BDO USA, LLP serving multi-national SEC registrants. Mr. Militello is a Certified Public Accountant and earned his Bachelor of Science degree in Accounting from St. Joseph’s College.

Pursuant to the terms of that certain employment letter, dated as of June 15, 2026, between Orphai Therapeutics, LLC and Mr. Militello (collectively, the “Militello Orphai Employment Agreement”), Mr. Militello will receive an annual base salary of $440,000 and a target annual bonus of 45% of his base salary. In addition, as a material inducement to his employment, Mr. Militello is entitled to receive, subject to approval by the Board, a restricted stock unit award with respect to 80,000 shares of the Company’s common stock, par value $0.001 per share (“Common Stock”), which will vest over a four year period, with 25% of the shares underlying the award vesting on July 6, 2027 and 6.25% of the shares underlying the award vesting at the end of each calendar quarter thereafter.

Pursuant to the terms of that certain change in control and severance agreement, dated as of September 16, 2026, between the Company and Mr. Militello (the “Militello Severance Agreement”), upon a termination by the Company without Cause outside of a Change in Control Period (as defined in the Militello Severance Agreement), Mr. Militello will be entitled to (i) cash severance in an amount equal to nine months of his base salary, and (ii) a lump-sum payment in an amount equal to the monthly premiums for COBRA continuation coverage, if he were to elect coverage for himself and his eligible dependents (based on the coverage levels in effect immediately prior to his termination and based on the premium amount that would be due for the first month of COBRA coverage if he were to elect such coverage). Additionally, upon a termination by the Company without Cause or if Mr. Militello resigned for Good Reason (as defined in the Militello Severance Agreement) during a Change in Control Period, Mr. Militello will be entitled to (i) cash severance in an amount equal to twelve months of his base salary, (ii) a cash payment in an amount equal to 100% of his target annual bonus for the year in which termination occurs, (iii) a lump sum payment equal to twelve months of COBRA continuation coverage, if he were to elect coverage for himself and his eligible dependents (based on the coverage levels in effect immediately prior to his termination and based on the premium amount that would be due for the first month of COBRA coverage if he were to elect such coverage), and (iv) 100% vesting of all outstanding time-based equity awards as of the later of the date of termination or a Change in Control (as defined in the Militello Severance Agreement). Receipt of the foregoing severance benefits is conditioned on Mr. Militello’s execution of a general release of claims in favor of the Company.

In connection with Mr. Militello’s appointment as Chief Financial Officer, the Board determined that Mr. Militello will succeed Mr. Hannah as the Company’s principal financial officer and principal accounting officer, effective as of the Effective Date.

The foregoing descriptions of the Militello Orphai Employment Agreement and Militello Severance Agreement do not purport to be complete and are qualified in its entirety by reference to the full text of the Militello Orphai Employment Agreement and Militello Severance Agreement, copies of which are attached hereto as Exhibits 10.2 and 10.3 and incorporated herein by reference.

Appointment of Chief Operating Officer

Effective as of the Effective Date, Keith Fandrick was appointed as Chief Operating Officer of the Company.

Keith Fandrick, age 47

Keith R. Fandrick, Ph.D., has served as the Company’s Head of Technical Operations since May 2026. Prior to that time, Dr. Fandrick served as Chief Operating Officer of Orphai, where he led operations, chemistry, manufacturing and controls, program management, regulatory strategy, external manufacturing and intellectual property activities for clinical-stage therapeutic programs since 2017, and he previously served in various other roles at Orphai, including as Chief Development Officer and Head of CMC. Previously, Dr. Fandrick served as a member of the Scientific Advisory Board of Drug Farm, Inc., where he advised on pharmaceutical development and CMC strategy. From 2007 to 2017, Dr. Fandrick held positions of increasing responsibility at Boehringer-Ingelheim. Dr. Fandrick is an author or co-author of 78 publications and patents. He holds Ph.D. and A.M. degrees in chemistry from Harvard University, an M.B.A. from the University of North Carolina at Chapel Hill’s Kenan-Flagler Business School, B.S. in chemistry from the University of California, San Diego, and a Regulatory Affairs Certification.

Pursuant to the terms of that certain employment letter, dated as of May 14, 2026, between the Company and Mr. Fandrick (the “Fandrick Employment Agreement”), which provides that the terms of his employment letter, dated as of May 12, 2026, by and between Orphai and Mr. Fandrick (the “Fandrick Orphai Employment Agreement”) would remain generally unchanged, Mr. Fandrick will receive an annual base salary of $450,000 and a target annual bonus of 45% of his base salary.

Pursuant to the terms of that certain severance agreement, dated as of March 3, 2025, between Orphai and Mr. Fandrick (the “Fandrick Orphai Severance Agreement”), upon a termination by the Company without Cause (as defined in the Fandrick Orphai Severance Agreement), Mr. Fandrick will be entitled to continued payments equal to his then-current base salary for a period of six months following termination. In addition, as of the termination date, all vested incentive-stock options shall convert to non-qualified stock options, exercisable up to the one-year anniversary date of termination; provided that no option shall have its term extended beyond the original expiration date set forth in the applicable option grant notice. Receipt of the foregoing severance benefits is conditioned on Mr. Fandrick’s execution of a general release of claims in favor of the Company.

The foregoing descriptions of the Fandrick Employment Agreement, Fandrick Orphai Employment Agreement and Fandrick Orphai Severance Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Fandrick Employment Agreement, Fandrick Orphai Employment Agreement and Fandrick Orphai Severance Agreement, copies of which are attached hereto as Exhibits 10.4, 10.5 and 10.6 and incorporated herein by reference.

Resignation of Directors

As previously announced, effective as of October 8, 2026, June Bray, David Lamond, Christopher Senner, and Mr. Thye resigned from the Board. The resignations were not the result of any disagreements with the Company relating to the Company’s operations, policies or practices.

Appointment of Directors

As previously announced, effective as of October 8, 2026:

• Catherine M. Bonuccelli was appointed to the Board as a Class I director and as a member of the Audit Committee and Compensation Committee of the Board;

• Leone Patterson was appointed to the Board as a Class III director and as chair of the Audit Committee and as chair of the Compensation Committee of the Board;

• James Valentine was appointed to the Board as a Class I director and as a member of the Audit Committee and as chair of the Nominating and Corporate Governance Committee of the Board; and

• Drayton Wise was appointed to the Board as a Class II director and as a member of the Nominating and Corporate Governance Committee of the Board.

Catherine M. Bonuccelli, M.D., age 68

Dr. Bonuccelli has served as principal and owner of CMB Life Sciences Consulting LLC since May 2024. Previously, Dr. Bonuccelli served as Chief Medical Officer of Bellus Health (acquired by GSK plc (NYSE: GSK) in 2023) from August 2019 to April 2024, where she advanced an asset for refractory chronic cough into Phase 3 prior to the company’s acquisition. Prior to Bellus Health, she spent more than 25 years in large pharmaceutical companies in a broad variety of roles of increasing responsibility, including Global Medicines Clinical Vice President for the Inflammation, Neuroscience, & Respiratory Therapeutic Area and Therapy Area Clinical Vice

President, Respiratory and Inflammation, at AstraZeneca plc (NASDAQ: AZN), and US Respiratory Therapeutic Area Head at GlaxoSmithKline (now GSK plc (NYSE: GSK)). Dr. Bonuccelli has over 25 years of pharmaceutical experience and expertise in clinical and product development of both respiratory and non-respiratory products across all phases of drug development. Dr. Bonuccelli holds a B.S. in Chemistry from Georgetown University and an M.D. from the Johns Hopkins University School of Medicine. The Company believes that Dr. Bonuccelli’s extensive clinical and pharmaceutical product development experience qualifies her to serve as a director.

Leone Patterson, age 63

Ms. Patterson served as Executive Vice President, Chief Business Officer and Chief Financial Officer of Zymeworks, Inc. (NASDAQ: ZYME), a biotechnology company focused on developing novel, multifunctional biotherapeutics for difficult-to-treat diseases, from September 2024 to January 2026. Previously, Ms. Patterson served as Chief Financial Officer and Chief Business Officer of Tenaya Therapeutics, Inc. (NASDAQ: TNYA) from June 2021 to July 2024. Earlier in her career, she held several roles at Adverum Biotechnologies, Inc., including SVP, Chief Financial Officer from June 2016 to May 2018, Interim Chief Executive Officer and Chief Financial Officer from May 2018 to October 2018, Chief Executive Officer from October 2018 to June 2020 and President and Chief Financial Officer from July 2020 to June 2021, as well as Chief Financial Officer at Diadexus, Inc. and Transcept Pharmaceuticals, Inc. Earlier in her career, she served in financial leadership roles at NetApp, Inc. (NASDAQ: NTAP), Exelixis, Inc. (NASDAQ: EXEL), Novartis AG (NYSE: NVS) and Chiron Corporation. Ms. Patterson has served as a director and chair of the audit committee of Kalaris Therapeutics, Inc. (NASDAQ: KLRS) since April 2025. Ms. Patterson has served as a director and chair of the audit committee of Nkarta, Inc. (NASDAQ: NKTX) since April 2020. Ms. Patterson also served as a director and member of the audit committee of Oxford Biomedica (UK) Limited from May 2023 to December 2024. Ms. Patterson also served on the board of directors, as chair of the audit committee, and as a member of the nominating and corporate governance committee, of Eliem Therapeutics, Inc. from June 2020 to January 2023 (Eliem Therapeutics subsequently changed its name to Climb Bio, Inc., which now trades on Nasdaq under the symbol CLYM). Ms. Patterson also served on the board of directors of Adverum Biotechnologies, Inc. from October 2018 to June 2020. Ms. Patterson earned a B.S. in Business Administration and Accounting from Chapman University and an Executive MBA from Saint Mary’s College, and is a Certified Public Accountant (inactive status). The Company believes that Ms. Patterson’s extensive public company financial leadership, governance and audit committee experience in the biopharmaceutical industry qualifies her to serve as a director.

James Valentine, age 40

Mr. Valentine has served as a Director of Hyman, Phelps & McNamara, P.C., a law firm specializing in food and drug law, since January 2023, and previously served as an Associate of the firm from May 2014 to December 2022. His practice focuses on regulatory matters relating to the development and approval of drugs and biologics, with particular expertise in rare disease drug development and patient-focused drug development. Prior to joining Hyman, Phelps & McNamara, Mr. Valentine held positions at the U.S. Food and Drug Administration, including in the Office of Special Health Issues and the Center for Drug Evaluation and Research’s Office of Regulatory Policy. Mr. Valentine has served on the Board of Directors of the RARE Foundation, formerly the EveryLife Foundation for Rare Diseases, since January 2026 and as Vice Chair since June 2026. Mr. Valentine holds a J.D. from the University of Maryland Francis King Carey School of Law, an M.H.S. from the Johns Hopkins Bloomberg School of Public Health, and a B.A. from the University of Maryland, Baltimore County. The Company believes that Mr. Valentine’s extensive regulatory and legal experience in rare disease drug development qualifies him to serve as a director.

Drayton Wise, age 51

Mr. Wise served at Insmed Incorporated (NASDAQ: INSM) from February 2014 to April 2025, including as Chief Commercial Officer from May 2022 to April 2025, where he led the global launch of ARIKAYCE across the United States, Europe and Japan, establishing it as one of the top ten non-oncology rare disease launches in the United States, and oversaw commercialization strategy, team buildout, launch readiness and cross-regional execution. Prior to Insmed, Mr. Wise held senior leadership roles at Novartis AG (NYSE: NVS) from 1999 to 2014, including as National Director, Cystic Fibrosis Sales & Account Management from June 2012 to February 2014. During his tenure at Novartis, he contributed to the launch of 14 products across multiple disease areas, including Tobi Podhaler. Mr. Wise has 25 years of leadership experience in global biopharmaceuticals and rare disease commercialization, with a strong focus on rare pulmonary diseases. Mr. Wise holds a B.A. in Business from The Citadel and an M.B.A. from Emory University. The Company believes that Mr. Wise’s extensive commercial leadership experience in the biopharmaceutical and rare disease industries qualifies him to serve as a director.

There are no family relationships between Messrs. Valentine and Wise or Mses. Bonuccelli and Patterson and any of the executive officers or directors of the Company. There are no arrangements or understandings between Messrs. Valentine and Wise or Mses. Bonuccelli and Patterson and any other person pursuant to which either was appointed as a director of the Company. Neither Messrs. Valentine and Wise or Mses. Bonuccelli and Patterson is a party to any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

Indemnification Agreements

In connection with their appointments as officers and directors, each of Messrs. Fandrick, Militello, Valentine and Wise and Mses. Bonuccelli, Patterson and Roberts will enter into the Company’s standard form of indemnification agreement for executive officers and directors.

Item 5.03. Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Years.

On October 8, 2026, the Company filed with the Secretary of State of the State of Delaware an amendment to its Amended and Restated Certificate of Incorporation to change the name of the Company from “Quince Therapeutics, Inc.” to “IRulya Therapeutics Inc.” (the “Name Change Amendment”). The Name Change Amendment will become effective at 4:01 p.m., Eastern Time, on October 9, 2026.

The Board approved the Name Change Amendment pursuant to Section 242 of the General Corporation Law of the State of Delaware. Pursuant to Section 242 of the General Corporation Law of the State of Delaware, stockholder approval was not required to approve or effect the Name Change Amendment. The Name Change Amendment will not in any way affect the voting or other rights that accompany shares of Common Stock, or the validity or transferability of the shares of Common Stock currently outstanding.

The Common Stock will continue to be quoted on The Nasdaq Stock Market, but beginning with the opening of trading on October 12, 2026, trading is expected to be moved from the Nasdaq Global Select Market to the Nasdaq Capital Market and will trade under the new symbol “IRLA” (the “Symbol Change”). There will be no change to the Common Stock CUSIP in connection with the Name Change Amendment.

A copy of the Name Change Amendment is attached hereto as Exhibit 3.1 and incorporated herein by reference.

Item 7.01. Regulation FD Disclosure.

On October 9, 2026, the Company issued a press release announcing the Name Change Amendment and the Symbol Change, a copy of which is furnished herewith as Exhibit 99.1 and is incorporated by reference herein. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On October 7, 2026, the Board approved the termination of the Company’s Outside Director Compensation Policy, effective as of October 7, 2026.

Effective October 10, 2026, the Company relocated its principal executive office from 611 Gateway Boulevard, Suite 273, South San Francisco, CA, to 101 College Street, Suite 210, New Haven, CT 06510. The Company’s telephone number at its new principal executive office is 203-208-8994.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Exhibit Description
3.1		Certificate of Amendment to Amended and Restated Certificate of Incorporation, effective October 9, 2026
10.1		Severance Agreement, dated as of March 3, 2025, by and between Orphai Therapeutics, Inc. and Brigette Roberts
10.2		Employment Letter, dated as of June 15, 2026, by and between Orphai Therapeutics LLC and John Militello
10.3		Executive Change in Control and Severance Agreement, dated as of September 16, 2026, by and between IRulya Therapeutics Inc. (formerly Quince Therapeutics, Inc.) and John Militello
10.4		Employment Letter, dated as of May 14, 2026, by and between IRulya Therapeutics Inc. (formerly Quince Therapeutics, Inc.) and Keith Fandrick
10.5		Employment Letter, dated as of May 12, 2026, by and between Orphai Therapeutics, Inc. and Keith Fandrick
10.6		Severance Agreement, dated as of March 3, 2025, by and between Orphai Therapeutics, Inc. and Keith Fandrick
99.1		Press Release, dated October 9, 2026
104		Cover Page Interactive Data File (embedded with the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				Quince Therapeutics, Inc.
				By:		/s/ John Militello
Date: October 9, 2026				Name:		John Militello
				Title:		Chief Financial Officer

Exhibit 99.1

Quince Therapeutics Relaunches as IRulya Therapeutics with a Focus on the Clinical Development of LAM-001, Targeting a Key Pathway in Pulmonary Disease

Company common stock to trade on Nasdaq under the symbol “IRLA” effective October 12, 2026

Key Management changes include new CEO, Brigette Roberts, M.D.; new CFO, John Militello, CPA; and new COO Keith R. Fandrick, Ph.D.

Board strengthened with the addition of Catherine Bonuccelli, M.D., Leone Patterson, James Valentine, J.D., M.H.S., and Drayton Wise

Cash balance of $116 million as of June 30, 2026 expected to fund operations through the end of 2028, supporting anticipated clinical data readouts from Phase 2 studies of LAM-001 in BOS, PH-ILD, and SAPH

South San Francisco, CA, October 9, 2026 – Quince Therapeutics, Inc. (Nasdaq: QNCX), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious underserved diseases, today announced that it has changed its name to IRulya Therapeutics Inc. effective at 4:01 p.m. Eastern Time. IRulya will be focused on advancing LAM-001, an investigational formulation of inhaled rapamycin (mTOR inhibitor) for multiple pulmonary diseases. The Company’s common stock will begin trading on the Nasdaq Capital Market under the ticker “IRLA” effective October 12, 2026.

The name change follows the completion of Quince’s previously announced merger with privately held Orphai Therapeutics and a concurrent private placement of approximately $115 million in upfront gross proceeds in May 2026.

“Today marks an important milestone as we introduce our newly transformed company as IRulya Therapeutics,” said Brigette Roberts, M.D., Chief Executive Officer of IRulya Therapeutics. “With a focus on the clinical development of LAM-001, a potentially first in class, one puff once daily dry powder inhaled (DPI) formulation of rapamycin, we believe we have an opportunity to change the current treatment paradigm for serious pulmonary diseases. Importantly, our strengthened balance sheet positions us well to advance LAM-001 through data readouts across Phase 2 clinical studies in three pulmonary indications: BOS, PH-ILD, and SAPH.”

IRulya Clinical Pipeline

LAM-001 is a proprietary, once-daily inhaled formulation of rapamycin designed to enhance pulmonary delivery and reduce systemic exposure relative to oral or systemic administration. The mTOR pathway is a central regulator of cell growth, repair and response to stress. Hyperactivated mTOR is implicated in multiple pulmonary diseases, where inhibition of mTOR with rapamycin has been shown in nonclinical models to reduce or reverse the disease process. IRulya is currently focused on developing LAM-001 in the following indications:

• Pulmonary hypertension associated with interstitial lung disease (PH-ILD) — a condition which leads to thickening and narrowing of pulmonary blood vessels and progressive cardiopulmonary failure. PH-ILD affects an estimated ~200,000 patients in the US and Europe. Inhibition of mTOR with rapamycin has been shown in nonclinical models of pulmonary hypertension to reverse smooth muscle cell hyperproliferation, attenuate pulmonary vascular remodeling and reduce fibrotic disease activity. A Phase 2a study of LAM-001 achieved clinically meaningful improvements across functional, hemodynamic and biomarker measures in patients with PH-ILD and pulmonary arterial hypertension. The Company recently initiated a Phase 2b trial in PH-ILD, and data are anticipated in the first quarter of 2028.

• Bronchiolitis obliterans syndrome post lung transplant (BOS) — the most common form of chronic transplant rejection in lung transplant patients, with no approved therapy and a median survival of 2.5 years after diagnosis. BOS prevalence is estimated at ~30,000 patients in the US and Europe by 2032. In nonclinical models, rapamycin was shown to reduce epithelial injury, limit fibrocyte migration, and boost anti-inflammatory cell infiltration, attenuating the dysregulated fibrocyte trafficking in BOS that drives airway obstruction. LAM-001 is currently being evaluated in an ongoing Phase 2 trial in BOS, with data anticipated in the first quarter of 2027.

• Sarcoidosis-associated pulmonary hypertension (SAPH) — a severe complication of pulmonary sarcoidosis with no approved therapy, affecting an estimated ~60,000 patients in the US and Europe. SAPH exhibits the same core mTOR-linked pulmonary vascular remodeling seen in PH-ILD, including smooth muscle hyperproliferation and fibrosis, which drive increased pulmonary pressures and progressive right-heart dysfunction. In addition, hyperactive mTOR in SAPH can promote pulmonary granuloma formation and contribute to vascular distortion, and mTOR inhibition has been demonstrated to reduce granuloma development. The Company plans to initiate a Phase 2 study in SAPH in 4Q26, with data anticipated in the fourth quarter of 2028.

Leadership and Corporate Updates

The following leadership changes were also announced today:

• Brigette Roberts, M.D., appointed Chief Executive Officer of IRulya and continues to serve on the Board. An experienced biotech investor and company builder, Dr. Roberts transformed Orphai Therapeutics into a differentiated pulmonary-focused company centered on LAM-001, leading to its merger with Quince. Dr. Roberts previously served as Board Member and Chief Corporate Affairs Officer of Quince and was Chief Executive Officer of Orphai Therapeutics. Prior to this, Dr. Roberts spent 15 years as a healthcare investor and portfolio manager at Third Point, CDP Capital, Angel Lane Principal Strategies, and DKR Capital, and founded the healthcare investment fund YYC Capital. Dr. Roberts holds a B.A. in Physics and Chemistry from Harvard University and an M.D. from New York University.

• John Militello, CPA., appointed Chief Financial Officer. With more than 25 years of experience in public accounting, including 12 years as a senior financial officer in publicly listed biotech companies, Mr. Militello brings an extensive background in financial oversight and management. Mr. Militello previously served as Head of Finance at Quince. Prior to that, he served as VP of Finance, Sr. Controller, Treasurer and Principal Accounting Officer of Rocket Pharmaceuticals, Inc. and was a Senior Manager in the biotech practice of BDO USA, LLP, serving multi-national publicly listed companies. Mr. Militello is a Certified Public Accountant and earned his Bachelor of Science degree in Accounting from St. Joseph’s College.

• Keith R. Fandrick, Ph.D., appointed Chief Operating Officer. With more than 18 years of experience in the pharmaceutical and biotech industries, Dr. Fandrick brings deep scientific, operational, and developmental expertise to clinical-stage development and commercialization. Dr. Fandrick previously served as Head of Technical Operations at Quince and was Chief Operating Officer of Orphai Therapeutics. Prior to his work at Orphai, Dr. Fandrick held positions of increasing responsibility at Boehringer-Ingelheim in Chemical Development. Dr. Fandrick holds Ph.D. and A.M. degrees in chemistry from Harvard University, an M.B.A. from the University of North Carolina at Chapel Hill’s Kenan-Flagler Business School, a B.S. in chemistry from the University of California, San Diego, and a Regulatory Affairs Certification.

• Dirk Thye, the Chief Executive Officer and Chief Medical Officer of Quince, and a member of the Company’s Board of Directors, and Brendan Hannah, the Company’s Chief Operating Officer, Chief Business Officer and Chief Compliance Officer, have resigned.

IRulya is strengthening its Board of Directors with the following appointments:

• Catherine Bonuccelli, M.D.: Dr. Bonuccelli is a Johns Hopkins trained pediatric pulmonologist with more than 25 years of pharmaceutical experience and deep expertise in clinical and product development of both respiratory and non-respiratory products across all phases of drug development. Dr. Bonuccelli has held clinical leadership positions at Bellus Health, GSK, and AstraZeneca.

• Leone Patterson: Ms. Patterson has more than 20 years of public company experience in the biopharma industry, with significant expertise in strategy, finance, operations, and governance. Most recently, she served as Chief Business and Financial Officer of Zymeworks, Inc., and previously served in financial leadership roles at Exelixis, Novartis AG and Chiron. She currently serves on the Boards of Directors of Nkarta, Inc. and Kalaris Therapeutics, Inc.

• James Valentine, J.D., M.H.S.: Mr. Valentine brings nearly two decades of experience in drug development, FDA regulatory strategy, and related policy, spanning roles in government, private practice, and patient advocacy. He is a Director at Hyman, Phelps & McNamara, P.C., a leading food and drug regulatory law firm, and previously served at the U.S. Food and Drug Administration.

• Drayton Wise: Mr. Wise is the former Chief Commercial Officer at Insmed with more than 25 years of executive leadership in global biopharmaceuticals and rare disease commercialization. At Insmed, he led the global launch of ARIKAYCE across the U.S., Europe, and Japan, and previously held senior leadership roles at Novartis.

Transaction Update

On October 6, 2026, stockholders approved the issuance of shares of common stock upon conversion of the Company’s Series C preferred stock and exercise of warrants issued in connection with the May 2026 acquisition of Orphai Holdings Therapeutics, Inc. and concurrent private placement as well as the shares of common stock issuable upon exercise of legacy Orphai options assumed in the transaction. As a result, outstanding shares of the Company’s Series C preferred stock will automatically convert into common stock effective at 5:00p ET on October 9, 2026, subject to certain beneficial ownership limitations set by each holder. The Company expects that following the conversion, its outstanding common stock will be approximately 10,841,470.

About IRulya Therapeutics, Inc.

IRulya Therapeutics Inc. is committed to transforming the lives of patients facing serious, underserved diseases by developing disease-modifying therapies to treat their conditions. The company is currently developing LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), bronchiolitis obliterans syndrome post lung transplant (BOS), and sarcoidosis associated pulmonary hypertension (SAPH). A Phase 2a study in PH patients has been completed, a Phase 2 clinical study in BOS patients is ongoing, a Phase 2b clinical study in PH-ILD is ongoing, and a Phase 2 clinical study in SAPH is anticipated to begin in 4Q26. By pioneering innovative approaches, the company aims to offer new hope and improved quality of life to patients worldwide.

Forward-Looking Statements

Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the design and potential benefits of LAM-001, including as a disease-modifying therapy for

pulmonary disease; anticipated regulatory and development processes and timelines, including the expected timing to initiate the planned Phase 2 trial of LAM-001 in SAPH and the expected timing for data readouts, the expected timing for data readouts from the ongoing Phase 2 trial of LAM-001 in BOS and the ongoing Phase 2b trial of LAM-001 in PH-ILD; the estimated patient populations in the U.S. and Europe for PH-ILD, BOS and SAPH; the potential advantages of mTOR inhibitors in PH-ILD, BOS and SAPH; the Company’s anticipated cash runway, including to fund operations through the end of 2028; the expected date of the Company’s trading on the Nasdaq Capital Market under its new ticker symbol; and the expected number of shares of common stock that will be outstanding following the conversion. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to LAM-001; the ability to obtain and maintain regulatory approval; competition in the company’s industry; the scope, progress and expansion of developing LAM-001; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the company’s ability to attract or retain key management, members of the board of directors and other personnel; the company’s ability to fund its operations and clinical development plans, including its anticipated cash runway; the impacts of general macroeconomic and geopolitical conditions on the company’s business and financial position; and other risks and uncertainties described in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on August 14, 2026 and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.

Contact

Joyce Allaire

LifeSci Advisors, LLC

jallaire@lifesciadvisors.com

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