Faeth Therapeutics Q3 loss widens to $20.4M

The company anticipates topline Phase 2 endometrial-cancer data by year-end 2026 and initial breast-cancer trial data in 2027.

Available on EDGAR 11/03/2026 - 08:14 AM EST Accepted by SEC EDGAR 11/03/2026 - 08:14 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Faeth Therapeutics, Inc. reported a net loss of $20.398 million for the quarter ended September 30, 2026, compared with $4.569 million a year earlier. Research and development expense was $11.736 million, versus $2.536 million. As of September 30, 2026, cash and cash equivalents were $14.180 million and marketable securities were $160.615 million.

The company said PK/PD analysis informed the PIKTOR dose in its Phase 2 PIK-201 trial, and PIKTOR plus paclitaxel received Fast Track designation for biomarker-selected advanced endometrial cancer. Topline PIK-201 data are anticipated by year-end 2026; initial safety and efficacy data from the PIK-101 breast cancer trial are anticipated in 2027.

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Negative

• Moderate pointNet loss was $20.398 million in Q3 2026 versus $4.569 million in Q3 2025.

Filing Explained

The release reports weighted-average common shares outstanding of 25,840,555 for the September 2026 quarter, versus 1,261,290 in the same quarter a year earlier—a higher average share count in the more recent period.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

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

Key Figures

Net loss: $20.398 million Research and development expense: $11.736 million General and administrative expense: $10.350 million +4 more

7 metrics

Net loss $20.398 million Quarter ended September 30, 2026; $4.569 million for the quarter ended September 30, 2025

Research and development expense $11.736 million Quarter ended September 30, 2026; $2.536 million for the quarter ended September 30, 2025

General and administrative expense $10.350 million Quarter ended September 30, 2026; $2.315 million for the quarter ended September 30, 2025

Net loss per share, basic and diluted ($0.79) per share Quarter ended September 30, 2026; ($3.62) per share for the quarter ended September 30, 2025

Cash and cash equivalents $14.180 million As of September 30, 2026; $8.668 million as of December 31, 2025

Marketable securities $160.615 million As of September 30, 2026; $12.516 million as of December 31, 2025

Total assets $178.949 million As of September 30, 2026; $22.902 million as of December 31, 2025

Key Terms

PK/PD analysis, Fast Track designation, PI3K-alpha inhibitor, mTORC1/mTORC2 inhibitor

4 terms

PK/PD analysis medical

"presented PK/PD analysis that informed the PIKTOR dose"

Fast Track designation regulatory

"received Fast Track designation for PIKTOR plus paclitaxel"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

PI3K-alpha inhibitor medical

"a selective PI3K-alpha inhibitor"

mTORC1/mTORC2 inhibitor medical

"an mTORC1/mTORC2 inhibitor"

Earnings Snapshot

Research and development: $11.736 million

Quarter ended September 30, 2026

Research and development $11.736 million Compared with $2.536 million for the quarter ended September 30, 2025

General and administrative $10.350 million Compared with $2.315 million for the quarter ended September 30, 2025

Loss from operations $22.086 million loss Compared with $4.851 million loss for the quarter ended September 30, 2025

Net loss $20.398 million loss Compared with $4.569 million loss for the quarter ended September 30, 2025

Net loss per share, basic and diluted ($0.79) per share Compared with ($3.62) per share for the quarter ended September 30, 2025

FAQ

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

What was Faeth Therapeutics' FTH net loss in Q3 2026?

Faeth reported a net loss of $20.398 million for the quarter ended September 30, 2026, compared with $4.569 million for the quarter ended September 30, 2025.

How much cash and marketable securities did Faeth Therapeutics have?

As of September 30, 2026, Faeth reported $14.180 million in cash and cash equivalents and $160.615 million in marketable securities.

What cancers are Faeth's PIKTOR studies evaluating?

PIK-201 is a Phase 2 trial in second-line advanced endometrial cancer. PIK-101 is a Phase 1b/2 trial in HR+/HER2- advanced breast cancer; the first patient was dosed in April 2026.

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

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false 0001829802 0001829802 2026-11-03 2026-11-03

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 3, 2026

Faeth Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-39980		83-1863385
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

701 Tillery Street, #12, #1010 Austin, TX		78702
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (512) 200-2982

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 Securities Exchange Act of 1934:

Title of each class		Trading symbol		Name of each exchange on which registered
Common Stock		FTH		The Nasdaq Stock Market LLC

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 3, 2026, Faeth Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item 2.02 and the exhibit attached hereto are being furnished and shall not be deemed “filed” for the 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 they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Exhibit Description
99.1		Press Release of Faeth Therapeutics, Inc., dated November 3, 2026
104		The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

2

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.

						Faeth Therapeutics, Inc.
Date: November 3, 2026						/s/ Christopher W. Gerry
						Christopher W. Gerry
						General Counsel and Secretary

3

Exhibit 99.1

Faeth Therapeutics Reports Third Quarter 2026 Financial Results and Operational Updates

• Topline results from the Phase 2 PIK-201 trial in endometrial cancer expected by year-end

• FDA granted Fast Track designation to PIKTOR plus paclitaxel in biomarker-selected advanced endometrial cancer

• Presented preclinical data on PIKTOR in HR+/HER2- breast cancer models at ESMO 2026

AUSTIN, Texas—(BUSINESS WIRE)—November 3, 2026— Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced financial results for the quarter ended September 30, 2026, and highlighted recent corporate accomplishments and 2026 milestones.

“Since our last quarterly update, we presented PK/PD analysis that informed the PIKTOR dose in our Phase 2 PIK-201 trial and received Fast Track designation for PIKTOR plus paclitaxel in biomarker-selected advanced endometrial cancer,” said Anand Parikh, Chief Executive Officer. “The PAM pathway is dysregulated in up to 50% of solid tumors, and feedback reactivation and resistance mutations may limit single-node inhibitors. We designed PIKTOR, an all-oral, multi-node inhibitor, to address those limitations, and we believe it has the potential to give patients a differentiated treatment option. We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer by year-end, and to reporting initial safety and efficacy data from our PIK-101 trial in HR+/HER2- breast cancer in 2027.”

Recent Corporate Updates:

• Presented preclinical data on PIKTOR in HR+/HER2- breast cancer models at the European Society for Medical Oncology (ESMO) Congress 2026 (Abstract 431P). PIKTOR was tested as monotherapy and in combination with SERDs and CDK inhibitors. In these preclinical models, PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding those observed with tested single-node inhibitors

• Presented PK/PD analysis at the 2026 Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer) that informed selection of 3 mg sapanisertib and 200 mg serabelisib three days a week as the recommended Phase 2 dose for PIKTOR in the PIK-201 trial

• FDA granted Fast Track designation to PIKTOR in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR (PAM) pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor

• Hosted a virtual key opinion leader event on multi-nodal inhibition for the treatment of endometrial cancer featuring Marcus Goncalves, M.D., Ph.D., of NYU Langone Health and a scientific co-founder of Faeth. A replay is available here

• Appointed Deepak Tiwari as Senior Vice President, Technical Operations, and Matt Biegler as Senior Vice President, Investor Relations, and added Karen Vousden, Ph.D., and Adam Schayowitz, Ph.D., MBA, to the Board of Directors

Third Quarter 2026 Financial Results

• Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $174.8 million as of September 30, 2026, as compared to $21.2 million as of December 31, 2025.

• Research and Development Expenses (R&D): R&D expenses for the quarter ended September 30, 2026 were $11.7 million, compared to $2.5 million for the quarter ended September 30, 2025. The increase in R&D expenses was primarily driven by development costs for PIKTOR and other Faeth programs, including clinical trial, chemistry, manufacturing and controls (CMC) and preclinical expenses, together with higher personnel costs, partially offset by lower clinical trial costs for legacy Sensei programs.

• General and Administrative Expenses (G&A): G&A expenses for the quarter ended September 30, 2026, were $10.4 million, compared to $2.3 million for the quarter ended September 30, 2025. The increase in G&A expenses was primarily attributable to higher personnel costs and increased external administrative fees, primarily legal fees.

• Net Loss: Net loss was $20.4 million, or $0.79 per basic and diluted share, for the quarter ended September 30, 2026, compared with a net loss of $4.6 million, or $3.62 per basic and diluted share, for the quarter ended September 30, 2025.

Weighted-average common shares outstanding, basic and diluted, were 25,840,555 for the quarter ended September 30, 2026, compared with 1,261,290 for the quarter ended September 30, 2025.

Condensed Statements of Operations

(Unaudited, in thousands except share and per share data)

		For the Three Months Ended September 30,
		2026				2025
Operating expenses:
Research and development		$	11,736			$	2,536
General and administrative			10,350				2,315
Total operating expenses			22,086				4,851
Loss from operations			(22,086	)			(4,851	)
Total other income			1,688				282
Net loss			(20,398	)			(4,569	)
Net loss per share, basic and diluted		$	(0.79	)		$	(3.62	)
Weighted-average common shares outstanding, basic and diluted			25,840,555				1,261,290

Selected Condensed Balance Sheet Data

(Unaudited, in thousands)

		September 30, 2026				December 31, 2025
Cash and cash equivalents		$	14,180			$	8,668
Marketable securities			160,615				12,516
Total assets			178,949				22,902
Total liabilities			11,085				4,310
Series B redeemable convertible preferred stock			6,767				—
Total stockholders’ equity			161,097				18,592

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. This multi-node approach is designed to address the signaling feedback reactivation and treatment-emergent resistance mutations that may limit the efficacy of single-node PI3K/AKT/mTOR pathway inhibitors. According to published literature, the PAM pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology.

PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

About Faeth Therapeutics

Faeth Therapeutics, Inc. (Nasdaq: FTH) is a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. The Company’s lead program is PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib in development for endometrial and breast cancer. Faeth was co-founded in 2019 by Anand Parikh and Oliver Maddocks, Ph.D., together with scientific founders Lewis Cantley, Ph.D., the discoverer of the PI3K pathway; Siddhartha Mukherjee, M.D., D.Phil.; Karen Vousden, Ph.D.; Scott Lowe, Ph.D.; and Greg Hannon, Ph.D. The Company intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, please visit www.faeththerapeutics.com and follow the Company on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “plan,” “may,” “will,” “would,” “could,” “should,” “estimate,” “potential,” “target,” “on track” and similar expressions, although not all forward-looking statements contain these words. These statements include, but are not limited to, statements regarding: the Company’s interpretation of preclinical, pharmacokinetic and pharmacodynamic data and the conclusions the Company draws from that data, including with respect to dose and schedule selection for PIKTOR and comparisons of PIKTOR’s preclinical profile to that of other tested inhibitors; the anticipated benefits of Fast Track Designation; the Company’s expectations regarding its pipeline and development plans, including the Phase 2 trial of PIKTOR in advanced endometrial cancer and the anticipated timing of topline data, and the Phase 1b/2 trial of PIKTOR in HR+/HER2- advanced breast cancer and the anticipated timing of interim data; the potential therapeutic benefits, tolerability profile and differentiation of PIKTOR; and the Company’s expectations regarding its cash runway.

Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, risks related to clinical development and the conduct, timing and results of clinical trials; the risk that results from preclinical studies, including comparisons with other product candidates or approved products, earlier clinical trials, modeling or other exploratory analyses may not be predictive of results in ongoing or future clinical trials; risks related to reliance on third parties for the supply of investigational agents used in combination studies; the Company’s cash position and anticipated cash runway; the Company’s need for additional financing; its limited operating history and history of operating losses; risks related to the integration of Faeth; the Company’s ability to satisfy applicable Nasdaq listing requirements and to maintain the listing of its common stock; and the other risks and uncertainties described under the headings “Risk Factors” and “Summary of Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2026, its Quarterly Report on Form 10-Q filed with the SEC on November 3, 2026, and its definitive proxy statement filed with the SEC on April 27, 2026, as well as in the Company’s subsequent filings. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required by law.

View source version on businesswire.com: [Insert Link]

Investor Contact:

Matthew Biegler, SVP, Investor Relations

matt@faeththerapeutics.com

Media Contact:

Patrick Schmidt, Consort Partners

faeththerapeutics@consortpartners.com

Source: Faeth Therapeutics, Inc.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 36.0 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 19.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.9 KB