QNCX

EX-99.1

2 d163839dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Quince Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Update

Completed acquisition of Orphai Therapeutics, adding LAM-001, an inhaled formulation of rapamycin for the treatment of multiple serious, underserved pulmonary diseases, to pipeline

LAM-001

Phase 2b data in PH-ILD anticipated in the first quarter of 2028; Phase 2 data in BOS anticipated in the first quarter of 2027

Closed private placement financing, receiving $115 million in upfront gross proceeds, with potential for up to an additional $83 million upon exercise of warrants (including warrants issued to former Orphai stockholders)

Cash and cash equivalents of $116 million as of June 30, 2026, expected to fund operations through the end of 2028

South San Francisco, CA, August 14, 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 provided a business update and reported financial results for the second quarter ended June 30, 2026.

“This was a transformational quarter for the company with a renewed focus on a differentiated, late-stage pulmonary pipeline anchored by LAM-001 as well as a strengthened balance sheet to support our development plans,” said Dr. Brigette Roberts, former CEO of Orphai Therapeutics and Chief Corporate Affairs Officer of Quince Therapeutics. “We are pleased to have initiated the Phase 2b trial of LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and look forward to releasing top line bronchiolitis obliterans syndrome post lung transplant (BOS) data in the first quarter of next year. Inhibition of the mTOR pathway via LAM-001 has the potential to offer PH-ILD and BOS patients a new treatment option that is designed to target and potentially reverse key elements of the underlying pathophysiology of these devastating diseases.”

Second Quarter and Recent Business Highlights

•

Completed Orphai acquisition and closed a concurrent $115 million private placement financing. On May 18, 2026, Quince completed a stock-for-stock merger to acquire Orphai, a clinical-stage biotechnology company, bringing Orphai’s lead program, LAM-001, an inhaled formulation of rapamycin (an mTOR inhibitor), into the pipeline. LAM-001 is being developed for the treatment of serious, underserved pulmonary diseases, including PH-ILD, BOS, and sarcoidosis-associated pulmonary hypertension (SAPH).

Concurrent with the acquisition, Quince entered into a definitive agreement for a private placement financing with gross upfront proceeds of $115 million, yielding net proceeds of $103.6 million after deducting placement agent and other offering expenses of $11.4 million, for the purchase of shares of Series C non-voting convertible preferred stock and up to an additional $83 million upon the exercise of warrants (including warrants issued to former Orphai stockholders).

•

Advancing the LAM-001 clinical program. Clinical sites have been

activated and the company is actively screening subjects for its Phase 2b trial of LAM-001 in PH-ILD. Topline data is anticipated in the first quarter of 2028. The company also continues to expect data from the Phase 2 trial of LAM-001 in BOS in the first quarter of 2027. The Phase 2 trial of LAM-001 in SAPH is anticipated to begin in late 2026, with data expected in the fourth quarter of 2028.

•

Presented new LAM-001 Phase 2a data at the American Thoracic Society

(ATS) Conference. Data from the Phase 2a trial of LAM-001 in 10 adult patients with PAH and PH-ILD demonstrated clinically meaningful improvement across functional, hemodynamic, and biomarker measures of disease. A mean improvement in six-minute walk distance (6MWD) of 67.4 meters and a mean reduction in pulmonary vascular resistance (PVR) (supine) of 33.9% at 24 weeks were seen in PH-ILD patients. A mean 6MWD improvement of 81.3 meters and a mean reduction in PVR (supine) of 28.1% were seen in the combined evaluable population of PAH and PH-ILD patients.The drug was generally well tolerated in both populations.

•

Formed Scientific Advisory Board (SAB). Appointed five internationally recognized experts in pulmonary medicine to an SAB – Dr. Paul Yu, Dr. Aaron Waxman, Dr. Steven Nathan, Dr. Steve Hays, and Dr. Robert Baughman – who Quince believes will be instrumental in helping to progress the development of LAM-001 across multiple pulmonary indications.

Second Quarter 2026 Financial Results

Cash position: Cash and cash equivalents were $116 million as of June 30, 2026, which reflects the $103.6 million in net upfront proceeds from the private placement. The Company expects that its cash position will be sufficient to fund operations through the end of 2028.

Research and development (R&D) expense: R&D expense for the three months ended June 30, 2026 was $5.5 million, compared t

8-K

false 0001662774 0001662774 2026-02-12 2026-02-12

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): February 12, 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

(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:

☐ 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 2.02 Results of Operations and Financial Condition.

As of December 31, 2025, Quince Therapeutics, Inc. (the “Company” or “we”) had approximately $5.8 million of cash and cash equivalents and $11.9 million of short-term investments, and $16.4 million outstanding on its unsecured line of credit between Quince Therapeutics, S.p.A and the European Investment Bank (the “EIB Loan”). The foregoing estimates are preliminary and unaudited and reflects the Company’s preliminary estimates with respect to its cash and short-term investments and balance of its EIB Loan at December 31, 2025, based on currently available information and is subject to completion of its year-end financial closing procedures. This estimate should not be viewed as a substitute for the Company’s annual financial statements prepared in accordance with U.S. generally accepted accounting practices. Neither the Company’s independent auditors, nor any other independent accountants, have audited, reviewed, compiled, examined, or performed any procedures with respect to this preliminary financial information. Further, the Company’s preliminary estimated results are not necessarily indicative of the results to be expected for any future period as a result of various factors.

Item. 8.01 Other Events.

The Company is updating certain disclosures about its business and the risk factors applicable to its business contained in its prior public filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Reports on the Form 10-Q for the period ended September 30, 2025 filed with the Securities and Exchange Commission. Preliminary Financial Data as of December 31, 2025 The information contained above in Item 2.02 is hereby incorporated by reference into this Item 8.01.

Strategic Alternatives On February 9, 2026, we engaged LifeSci Capital as our exclusive financial advisor to assist in restructuring activities and an evaluation of strategic alternatives aimed at maximizing shareholder value. Based on our initial evaluation, we plan to focus our efforts with respect to strategic alternatives, including effecting a reverse merger. We do not currently have any agreements or commitments to effect any such transactions and may not be able to execute such transactions on terms favorable to us and our stockholders, or at all. While we may also sell assets relating to our previous product candidates, we do not expect to receive any meaningful consideration from such sale, if any. In order to fund our current efforts to pursue strategic alternatives, including a reverse merger, we intend to obtain additional funding through available financing sources, which may include additional public offerings of common stock, including sales of common stock, under a Controlled Equity OfferingSM Sales Agreement, dated December 18, 2024, with Cantor Fitzgerald & Co. and H.C. Wainw

8-K

0001662774false00016627742025-11-122025-11-12

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): November 12, 2025

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

(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: ☐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 2.02 Results of Operations and Financial Condition. On November 12, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2025 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (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 provided by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press release issued by Quince Therapeutics, Inc. dated November 12, 2025

104

Cover Page Interactive Data File (embedded within 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.

Date:

November 12, 2025

By:

/s/ Dirk Thye

Name: Title:

Dirk Thye Chief Executive Officer and Chief Medical Officer