FTH

Faeth Therapeutics, Inc.

NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS

18.69

−0.06 −0.32%

USD · close Oct 30

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MKT CAP $483MP/E —DIV YIELD —FCF YIELD -7.01%REV TTM —NET INCOME −$195.5MNET CASH $26.3M52W 7.89 – 40.05SEC XBRL · TTM TO Invalid Date

How FTH rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Risk Factors in this Annual Report on Form 10-K, including the risk entitled “If our information systems or data, or those of our collaborators, contractors, consultants or other third parties with whom we work, are or were compromised, we could experience adverse consequences, including but not limited to regulatory investigations or actions; litigation; fines and penalties; significant disruption of our product development programs and our ability to operate our business effectively; reputational harm; and other adverse consequences.” Governance Our board of directors addresses our cybersecurity risk management as part of its general oversight function.
Our Vice President of Engineering, Vice President of Product, and General Counsel integrate cybersecurity risk considerations into the Company’s overall risk management strategy, communicate key priorities to relevant personnel, help prepare for cybersecurity incidents, approve cybersecurity processes, and review security assessments and other security-related reports.
Our Vice President of Engineering has approximately 15 years of experience in healthcare technology, including prior roles at Flatiron Health and Epic Systems involving systems that process sensitive patient data.
He has expertise in designing and operating systems subject to HIPAA and SOC 2 compliance requirements, including security architecture review, access control and authentication design, and participation in SOC 2 and HIPAA audit and incident response processes.
Our Vice President of Product has over 20 years of experience delivering products across the healthcare ecosystem, including digital health products used in clinical trial management and pharmaceutical ordering.
He has experience managing products subject to HIPAA and 21 CFR Part 11 regulatory requirements and maintains training related to HIPAA, data privacy, and security practices in regulated healthcare environments.
Our General Counsel oversees the Company's cybersecurity incident response processes and evaluates cybersecurity risks in the context of SEC disclosure obligations.
He has prior experience advising public and private companies on regulatory compliance and risk management, including matters involving data privacy and information security.
Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our General Counsel.
The General Counsel works with the Company’s incident responders in an effort to help mitigate and remediate cybersecurity incidents of which he is notified.
In addition, our incident response processes include reporting to our disclosure committee and audit committee of the board of directors for certain cybersecurity incidents.
Our audit committee receives periodic reports from management concerning the Company’s significant cybersecurity threats and risks and the processes designed to address them.
We also lease office and laboratory space in Rockville, Maryland at 1405 Research Blvd, Suite 125, which serves as our principal executive office.
The Rockville research operations were wound down in connection with the 2024 Restructuring, and the space is currently used on a limited basis for administrative purposes.
As of March 23, 2026, we had 1,340,281 shares of common stock outstanding held by 193 holders of record.
Recent Sales of Unregistered Securities On February 17, 2026, we completed the Acquisition pursuant to the Merger Agreement.
In connection with the closing of the Acquisition, we issued to the stockholders of Faeth HoldCo an aggregate of 10,497.0980 shares of our Series B Non-Voting Convertible Preferred Stock.
Each share of Series B Preferred Stock is convertible into 1,000 shares of our common stock, representing 10,497,098 shares on an as-converted-to-common-stock basis (without giving effect to any beneficial ownership limitations), subject to stockholder approval of the Company Stockholder Matters and certain beneficial ownership limitations established by each holder.
The shares of Series B Preferred Stock issued as Acquisition consideration were offered and sold in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.
On February 20, 2026, we completed a private placement of 14,440.395 shares of our Series B Preferred Stock at a purchase price of approximately $13,850 per share (or approximately $13.85 per share on an as-converted-to-common-stock basis) for aggregate gross proceeds of approximately $200 million.
The investors in the 2026 Private Placement included B Group Capital, Balyasny Asset Management, Columbia Threadneedle Investments, Cormorant Asset Management, Fairmount, Logos Capital, RA Capital Management, Vivo Capital and other institutional investors.
The Series B Preferred Stock issued in the 2026 Private Placement was offered and sold in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder, as a transaction by an issuer not involving a public offering.
Each of the investors represented that it was an "accredited investor" as defined in Regulation D and acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof.
Subject to stockholder approval of the Company Stockholder Matters, each share of Series B Preferred Stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations established by each holder; provided that such beneficial ownership limitations may be waived by each holder of Series B Preferred Stock at any time following the approval by Nasdaq of the Nasdaq Listing Application and approval of the Company Stockholder Matters upon notice to the Company.
We have agreed to file a registration statement on Form S-3 to register the resale of shares of common stock issuable upon conversion of the Series B Preferred Stock within 75 calendar days following the closing of the 2026 Private Placement.
For additional information regarding the Acquisition and the 2026 Private Placement, see the Current Report on Form 8-K filed with the SEC on February 18, 2026 and Note 15 to the consolidated financial statements included elsewhere in this Annual Report.
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2025, compared to the year ended December 31, 2024.
For a discussion and analysis comparing our results for the year ended December 31, 2024, to the year ended December 31, 2023, see our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 28, 2025, under Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Unless otherwise indicated, all information in this Annual Report on Form 10-K gives effect to a 1-for-20 reverse stock split of our common stock that became effective on June 16, 2025 (the “Reverse Stock Split”), and all references to historical share and per share amounts give effect to the Reverse Stock Split.
Overview We are a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways.
On February 17, 2026, we completed the Acquisition of Faeth Therapeutics, a clinical-stage biotechnology company developing multi-node therapies targeting tumor metabolism and signaling, and received $200 million in gross proceeds from the 2026 Private Placement from a broad syndicate of institutional investors.
The acquisition brought Faeth's lead asset, PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway, into our pipeline.
Because the Acquisition and 2026 Private Placement closed subsequent to the balance sheet date, the consolidated financial statements included in this Report reflect only the pre-acquisition operations of Sensei Biotherapeutics.
For additional information regarding the terms of the acquisition and the concurrent financing, see Note 15 to the consolidated financial statements.
Following the acquisition, our lead program is PIKTOR, an oral multi-node inhibitor of the PI3K/AKT/mTOR pathway in development for endometrial and breast cancer.
The PI3K/AKT/mTOR pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology.
Our core thesis is that simultaneously suppressing multiple pathway nodes can produce deeper, more durable tumor suppression than approved therapies that target only a single node.
PIKTOR is currently being evaluated in an ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026, and we intend to initiate a Phase 1b trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101) by the first half of 2026.
We believe the $200 million in financing proceeds, together with our existing cash and cash equivalents, will be sufficient to fund operations through these key clinical milestones.
Prior to the Acquisition, we were primarily focused on the development of solnerstotug (formerly SNS-101), our conditionally active monoclonal antibody targeting the immune checkpoint VISTA.
In November 2025, our Board of Directors approved a reduction in force of approximately 65% of our pre-acquisition workforce, referred to herein as the 2025 Restructuring, to preserve capital while we evaluated strategic alternatives, including the Acquisition.

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Risk Factors in this Annual Report on Form 10-K, including the risk entitled “ Our computer systems or data, or those of our collaborators or other contractors or consultants, maybe compromised, which could result in adverse consequences, including but not limited to regulatory investigations or actions; litigation; fines and penalties; significant disruption of our product development programs and our ability to operate our business effectively; reputational harm; and other adverse consequences .” Governance Our board of directors addresses our cybersecurity risk management as part of its general oversight function.
Our IT Lead is responsible for engaging and overseeing our IT Firm.
In consultation with our IT Firm, our IT Lead, Principal Financial Officer and General Counsel integrate cybersecurity risk considerations into the Company’s overall risk management strategy, communicate key priorities to relevant personnel, help prepare for cybersecurity incidents, approve cybersecurity processes, and review security assessments and other security-related reports.
Our cybersecurity incident response policy is designed to escalate certain cybersecurity incidents to our Cybersecurity Incident Management Team, which consists of a representative from our IT Firm, IT Lead, Principal Financial Officer and General Counsel.
In addition, our incident response policy includes reporting to our disclosure committee and audit committee of the board of directors for certain cybersecurity incidents.
Our audit committee receives periodic reports from management concerning the Company’s significant cybersecurity threats and risk and the processes the Company has implemented to address them.
As of March 24, 2025, we had 25,208,068 shares of common stock outstanding held by 196 holders of record.
Recent Sales of Unregistered Securities Not applicable.
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the year ended December 31, 2024, compared to the year ended December 31, 2023.
For a discussion and analysis comparing our results for the year ended December 31, 2023, to the year ended December 31, 2022, see our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 29, 2024, under Part II, Item 7 "Management’s Discussion and Analysis of Financial Condition and Results of Operations." Overview We are a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients.
Through our TMAb (Tumor Microenvironment Activated Biologics) platform, we are developing highly selective therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment.
Our strategy is to generate novel product candidates that incorporate next-generation technologies or approaches.
We plan to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into clinical trial designs targeted to well-defined patient populations.
We currently have one investigational product candidate, solnerstotug, in clinical development, and three preclinical product candidates. • Solnerstotug (formerly referred to as SNS-101) is our conditionally active monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T-cell activation). o In May 2023, we initiated a first-in-human Phase 1/2 open-label, multi-center, dose escalation and expansion trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of solnerstotug as monotherapy and/or in combination with cemiplimab in patients with advanced solid tumors. o As of March 17, 2025 an aggregate of 94 patients have been dosed in the Phase 1 portion of the clinical trial, consisting of 34 patients in the dose escalation cohort and 60 patients in the dose expansion cohort. o On March 27, 2025, we disclosed clinical data from the dose expansion portion of the clinical trial. o Subject to our ability to raise sufficient additional capital, we are planning to initiate a Phase 2 trial of solnerstotug in the first quarter of 2026, with the trial design and patient selection strategies to be informed by the ongoing dose expansion results. • SNS-102 is our conditionally active monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), an immune checkpoint often expressed on macrophages. • SNS-103 is our conditionally active monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1), also known as CD39. • SNS-201 is a bispecific antibody that is being designed to conditionally activate Cluster of Differentiation 28 (CD28).
It is a bispecific format with monovalent CD28 engagement and bivalent pH-selective VISTA binding for efficient engagement at low pH.
In November 2024, we announced a plan to decrease operating expenses, streamline operations and focus resources on advancing the clinical development of solnerstotug.
As a result, we closed our research site in Rockville, Maryland, reduced our workforce by approximately 46%, with most headcount reductions affecting our preclinical research and development group, and paused further development of our preclinical product candidates, including SNS-102, SNS-103 and SNS-201.
With this realignment of resources, we expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2026.
We plan to continue reviewing our financial resources with the expectation that work on our preclinical product candidates will resume if we raise sufficient additional capital.
We do not have any product candidates approved for sale, have not generated any revenue from product sales, and do not expect to generate any revenue from product sales for at least the next several years.
We have largely funded our operations with proceeds from the sale of convertible preferred stock, common stock and convertible debt.
Through the date of this Report, we have raised an aggregate of $123.4 million of gross proceeds from private placements of our equity and convertible debt securities and net proceeds of $138.5 million from our initial public offering, or IPO, in February 2021.
We have incurred significant operating losses over the last several years.
Our net loss was $30.2 million and $34.1 million for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, we had an accumulated deficit of $262.1 million.
We expect to continue to incur significant expenses and operating losses for the foreseeable future.
We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we: • conduct clinical trials of product candidates, including solnerstotug; • invest in our TMAb platform; • seek to discover and develop additional product candidates or acquire or in-license drugs, product candidates or technologies; • seek regulatory approvals for any product candidates that successfully complete clinical trials; • ultimately establish a sales, marketing and distribution infrastructure and scale up manufacturing capabilities to commercialize any product candidates for which we may obtain regulatory approval; • manufacture our product candidates or otherwise secure the clinical and commercial supply of our product candidates; • hire additional research and development and selling, general and administrative personnel; • maintain, expand and protect our intellectual property portfolio; and • incur costs associated with operating as a public company.
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses.
We expect to continue to incur net losses and negative cash flows for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase.
In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other increased costs associated with being a public company.
In addition, if we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product.
These expenses include: • expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials; • the cost of manufacturing our product candidates including the cost of contract manufacturing organizations, or CMOs, that manufacture product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities; • the cost of outsourced professional scientific development services; • employee-related expenses, including salaries, benefits and stock-based compensation for employees engaged in the research and development function; • expenses relating to regulatory activities, including filing fees paid to regulatory agencies; • fees for maintaining licenses and other amounts due under our third party licensing agreements; • laboratory materials and supplies used to support our research activities; and • allocated expenses for utilities and other facility-related costs.
Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities.
We use internal resources primarily to conduct research and manage our preclinical development, process development, manufacturing and clinical development activities.
These employees work across multiple development programs and, therefore, we do not track their costs by program and, as such, are not separately classified.
We expect our research and development expenses to increase over the next several years as we conduct our clinical trials, prepare regulatory filings for our product candidates and have increased costs associated with manufacturing.
We anticipate that our general and administrative expenses will decrease slightly due to reduced payroll costs following our November 2024 restructuring.
Infrastructure costs are expected to remain consistent, and other expenditures including consulting, legal, tax-related services, accounting, investor relations, and insurance premiums are expected to align with last year's levels.
Long-Lived Asset Impairment Our long-lived asset impairments consist of charges related to the write-down of certain equipment and finance right-of-use assets due to streamlining operations and focusing resources on advancing the clinical development of solnerstotug.
Other Income (Expense) Our other income (expense) consists of accretion on short-term investments, litigation expense, interest expense and gain or loss on fixed asset disposals.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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