Form 8-K
8-K — Quince Therapeutics, Inc.
Accession: 0001193125-26-350568
Filed: 2026-08-14
Period: 2026-08-14
CIK: 0001662774
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — d163839d8k.htm (Primary)
EX-99.1 (d163839dex991.htm)
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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): August 14, 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 240.13d-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 August 14, 2026, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2026 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
Number
Description
99.1
Press Release issued by Quince Therapeutics, Inc. dated August 14, 2026
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.
By:
/s/ Dirk Thye
Date: August 14, 2026
Name:
Dirk Thye
Title:
Chief Executive Officer
EX-99.1
EX-99.1
Filename: d163839dex991.htm · Sequence: 2
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 to $6.6 million for the three months ended June 30, 2025. The decrease in R&D expense is primarily due to
the decrease in the eDSP program costs due to the wind down of the program. LAM-001 costs increased $0.8 million as a result of study start-up costs.
General and administrative (G&A) expense: G&A expense for the three months ended June 30, 2026 was $16.6 million, compared to
$3.3 million for the three months ended June 30, 2025. The increase in G&A expense is due to $9.1 million in non-cash stock based compensation due to a
one-time charge due to the assumption of historical options upon the closing of the acquisition and an increase of $4.4 million in professional fees due to the Quince restructuring prior to the completion
of the acquisition.
Net loss: Quince reported a net loss of $75.5 million, or net loss per share of $12.31 per basic and diluted share, for
the three months ended June 30, 2026, compared to a net loss of $16.0 million, or net loss per share of $68.75 per basic and diluted share for the three months ended June 30, 2025.
Shares outstanding: 978,022 shares of common stock were outstanding as of June 30, 2026.
On April 10, 2026, Quince effected a reverse stock split of all shares of its issued and outstanding
common stock at a ratio of 1-for-10. On June 29, 2026, Quince effected a reverse stock split of all shares of its issued and outstanding common stock at a ratio of 1-for-20. All issued and outstanding shares of common stock and share-based awards’ exercise prices and per share data herein have been adjusted, on a retrospective
basis, to reflect the reverse stock splits. The number of authorized shares and par value of the common stock were not adjusted because of the reverse stock splits.
About LAM-001
LAM-001 is a proprietary, investigational, once-daily inhaled formulation of rapamycin, also known as sirolimus. LAM-001’s potential as a disease-modifying agent in PH stems from its ability to inhibit mTOR-mediated pulmonary arterial smooth muscle cell proliferation, to limit endothelial cell dysfunction, and to
suppress inflammatory signaling, leading to improvement in pulmonary vascular remodeling. The mTOR pathway has been shown to be activated in pulmonary arteries of patients with PH, and mTOR inhibition with rapamycin has been shown to reverse smooth
muscle cell hyperproliferation and to attenuate pulmonary vascular remodeling and cardiopulmonary dysfunction in multiple published nonclinical models. Additionally, in published non-clinical studies,
hyperactive mTOR signaling has been shown to promote fibroblast activation, myofibroblast differentiation, and extracellular matrix deposition in injured or inflamed lung tissue, and mTOR inhibition has been shown to exert direct antifibrotic
activity, suppressing profibrotic cytokine signaling, reducing collagen accumulation, and attenuating parenchymal fibrosis. These effects are particularly relevant in PH-ILD, where vascular remodeling and
progressive fibrosis evolve in parallel and amplify pulmonary vascular load. LAM-001 is designed to enhance pulmonary delivery and to reduce systemic exposure of rapamycin, offering a promising, potentially
disease-modifying, therapy for multiple pulmonary diseases.
LAM-001 is currently being studied in multiple
indications including PH-ILD, a serious and progressive condition affecting an estimated 200,000 patients between the U.S. and Europe. Based on compelling Phase 2a data presented at the American Thoracic
Society (ATS) in May 2026, the company has advanced LAM-001 into a Phase 2b PH-ILD trial and data is anticipated in the first quarter of 2028. LAM-001 is also being evaluated in a Phase 2 study in bronchiolitis obliterans syndrome post lung transplant (BOS), a serious complication with an estimated prevalence of ~30K patients between the U.S. and Europe by
2032. The trial is fully enrolled, and data is anticipated in the first quarter of 2027. In late 2026, the company also plans to initiate a Phase 2 study of LAM-001 in sarcoidosis-associated pulmonary
hypertension (SAPH), a severe complication of pulmonary sarcoidosis with no approved therapy, that affects an estimated ~60K patients in the U.S. and Europe.
About Quince Therapeutics, Inc.
Quince 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 PH-ILD, BOS, and SAPH. A Phase 2a study in PH patients has been completed, a
Phase 2 clinical study in BOS patients is ongoing, a Phase 2b study in PH-ILD is ongoing, and a Phase 2 study in SAPH is anticipated to begin in late 2026. 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, 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 Phase 2a data of
LAM-001 in PAH and PH-ILD supporting continued development of LAM-001 in PH-ILD and the
potential benefit across exercise capacity, pulmonary hemodynamics, cardiac stress and lung function; observed improvements in 6MWD and PVR in the Phase 2a trial potentially suggesting broader effects on cardiopulmonary physiology; 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; and the company’s
anticipated cash runway. 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 Amendment No. 2 to its Current Report on Form 8-K filed with the Securities and Exchange
Commission (SEC) on July 30, 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.
Three Months Ended March 31,
Six Months Ended June 30,
2026
2025
2026
2025
Operating expenses:
Research and development
5,461
6,553
12,306
14,698
Acquired in-process research and development
59,000
—
59,000
—
General and administrative
16,626
3,342
20,893
8,131
Gain on Orphai Acquisition
(1,305
)
—
(1,305
)
—
Intangible asset impairment charge
—
—
67,808
—
Fair value adjustment for contingent consideration
—
532
(64,330
)
2,456
Total operating expenses
79,782
10,427
94,372
25,285
Loss from operations
(79,782
)
(10,427
)
(94,372
)
(25,285
)
Fair value adjustment for debt
—
(501
)
12,168
(945
)
Fair value adjustment for warrants
4,507
(4,464
)
35,623
(4,464
)
Warrant issuance costs
(874
)
(872
)
(874
)
(872
)
Interest income
584
311
744
717
Other income (expense), net
152
(29
)
1,871
(116
)
Net income (loss) before income tax expense
(75,413
)
(15,982
)
(44,840
)
(30,965
)
Income tax benefit (expense)
(75
)
(67
)
5,264
(114
)
Net loss
$
(75,488
)
$
(16,049
)
$
(39,576
)
$
(31,079
)
Net loss per share - basic and diluted (1)
$
(12.31
)
$
(68.75
)
$
(12.01
)
$
(137.17
)
Weighted-average common shares outstanding - basic and diluted (1)
6,132,845
233,431
3,295,727
226,571
June 30, 2026
December 31, 2025
Cash, cash equivalents, and investments
$
115,981
$
17,752
Total assets
123,995
93,523
Total liabilities
15,508
129,237
Series C Redeemable Convertible Preferred Stock
143,811
—
Total stockholders’ equity (deficit)
(35,324
)
(35,714
)
(1)
Adjusted prior period net loss per share and weighted average of common shares outstanding to reflect the 1-for-10 reverse stock split effected on April 10, 2026 and the 1-for-20 reverse stock
split effected on June 29, 2026
Contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
212-915-2577
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QUINCE THERAPEUTICS, INC.
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dei:tradingSymbolItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration