On March 4, 2026 Niagen Bioscience, Inc. (NASDAQ:NAGE) reported its fourth quarter and fiscal year 2025 financial results.

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Fourth Quarter 2025 Financial Highlights Compared to Prior Year Quarter

Total net sales increased 16% to $33.8 million, with Tru Niagen sales of $27.5 million, up 21% from the prior year quarter.
Gross margin increased 160 basis points to 64.1%.
Net income of $4.1 million compared to $7.2 million in the prior year quarter. Q4 2024 benefited from a $3.5 million reversal of previously accrued royalties and license maintenance fees, and a $1.3 million recovery of credit losses related to the Elysium Health settlement, while the current-year quarter benefited from a $2.0 million gain related to the settlement of royalty obligations.
Basic earnings per share was $0.05, and diluted earnings per share was $0.05, compared to $0.09 earnings per share in the prior year quarter for each.
Adjusted EBITDA, a non-GAAP measure, was $4.1 million, an increase of $0.7 million from the prior year quarter.
Full Year 2025 Financial Highlights Compared to Prior Year

Delivered on latest financial outlook across key metrics, demonstrating strong operational execution and focus on delivering shareholder value.
Total net sales increased 30% to $129.4 million, with Tru Niagen sales of $97.7 million and Niagen ingredient sales of $27.9 million, up 27% and 45%, respectively.
Gross margin increased 250 basis points to 64.3%.
Selling and marketing expense improved 220 basis points as a percentage of net sales to 27.4%, reflecting increased operating leverage.
Net income of $17.4 million, an increase of $8.8 million from $8.6 million in the prior year. The prior year included a $3.5 million reversal of previously accrued royalties and license maintenance fees, while 2025 included a $2.0 million gain related to the settlement of royalty obligations. Both years included a $1.3 million recovery of credit losses related to the Elysium Health settlement.
Basic earnings per share was $0.22, and diluted earnings per share was $0.20, improving from $0.11 earnings per share in the prior year for each.
Adjusted EBITDA, a non-GAAP measure, was $20.4 million, increasing $11.9 million year-over-year.
Generated positive operating cash flow of $13.5 million, ending the year with $64.8 million in cash and no outstanding borrowings.
Recent Operational Highlights

In February 2026, the Company sold substantially all of the assets of its analytical reference standards and services operating segment to a third party in an all-cash transaction for total consideration of approximately $6.0 million, less working capital adjustments of approximately $0.2 million. As of December 31, 2025, the assets of this segment were classified as held for sale and presented as such in the Company’s consolidated balance sheets.
In January 2026, the Company announced a partnership with Truemed enabling qualified U.S. customers to use Health Savings Account (HSA) and Flexible Spending Account (FSA) funds to purchase Tru Niagen on the Company’s direct-to-consumer website with a Truemed Letter of Medical Necessity (LMN). This update expands payment flexibility for eligible customers and reflects continued development of the Company’s consumer sales channels.
In December 2025, the Company acquired the core nicotinamide riboside (NR) patent portfolio from Queen’s University Belfast, resulting in sole ownership of the foundational composition-of-matter intellectual property underlying NR and its salt forms. The acquisition enhances the Company’s control over key IP supporting existing and potential future applications, including pharmaceutical development, and increases strategic and financial flexibility for the development, licensing, and commercialization of its intellectual property portfolio.
In November 2025, the Company launched Tru Niagen Beauty, a dietary supplement formulated with Niagen and other clinically studied ingredients designed to support skin, hair, and nail health. The product represents an expansion of the Company’s consumer portfolio into the beauty and nutricosmetics category and reflects the continued application of NAD+ science across additional consumer health verticals.
In November 2025, the Company announced results from a randomized, double-blind, placebo-controlled clinical trial evaluating Niagen supplementation in individuals with long COVID. The study demonstrated that Niagen supplementation increased NAD+ levels, supporting continued scientific evaluation of NAD+ restoration in populations experiencing prolonged post-viral symptoms.
"Niagen Bioscience delivered net sales of $33.8 million for the fourth quarter of 2025, representing a 16% increase compared to the prior year period, and generated net income of $4.1 million. For the full year, net sales were $129.4 million, an increase of 30% year-over-year, with net income of $17.4 million and operating cash flow of $13.5 million," said Rob Fried, Niagen Bioscience Chief Executive Officer. "We ended the year with $64.8 million in cash, providing a strong financial foundation to support continued investment in our strategic priorities and growth."

Results of operations for the three months ended December 31, 2025 compared to the prior year quarter

Net Sales for Niagen Bioscience increased 16%, or $4.7 million, to $33.8 million. Net sales growth was driven by a $4.8 million increase in Tru Niagen sales, largely attributed to e-commerce growth, partially offset by lower ingredient sales.

Gross Margin improved 160 basis points to 64.1% driven by the sale of lower-cost inventory and improved labor and overhead utilization on higher sales volume.

Operating Expense, net increased 59%, or $6.5 million, to $17.6 million.

General and administrative (G&A) expense increased by $6.4 million compared to the prior year quarter, primarily reflecting the absence of a $3.5 million reversal of previously accrued royalties and license maintenance fees, and a $1.3 million recovery of credit losses related to the Elysium Health legal settlement in the prior year quarter, as well as higher employee-related and share-based compensation expenses.
Selling and marketing (S&M) expense and research and development (R&D) expense increased by $1.7 million and $0.4 million, respectively, reflecting higher investments to support brand growth, product development initiatives, and clinical activities.
Higher operating expenses were partially offset by a $2.0 million gain recognized during the fourth quarter of 2025 related to the settlement of royalty obligations under a settlement agreement with Queen’s University Belfast.
Net Income was $4.1 million compared to $7.2 million for the fourth quarter of 2024, primarily driven by elevated operating expenses in the current year quarter, as the prior year quarter included benefits that exceeded the $2.0 million gain recognized in the current quarter.

Basic and Diluted Earnings Per Share were $0.05 and $0.05, respectively, compared to $0.09 for both basic and diluted earnings per share in the prior year quarter.

Adjusted EBITDA, a non-GAAP measure, was $4.1 million, an increase of $0.7 million from $3.4 million for the fourth quarter of 2024. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net income, the most directly comparable GAAP measure.

Results of operations for the year ended December 31, 2025 compared to the prior year

Net Sales for Niagen Bioscience increased 30%, or $29.8 million, to $129.4 million. Net sales growth was driven by $20.9 million increase in Tru Niagen sales and $8.9 million increase in ingredient sales, largely from food-grade Niagen.

Gross Margin improved 250 basis points to 64.3%, driven by favorable product mix, the sale of lower-cost inventory, and improved labor and overhead utilization on higher sales volume.

Operating Expense, net increased 24%, or $13.1 million, to $66.9 million.

G&A expense increased by $8.7 million, year-over-year, reflecting the absence of a $3.5 million reversal of previously accrued royalties and license maintenance fees recorded in 2024, as well as higher employee-related expenses, share-based compensation, and professional and consulting fees.
S&M expense increased by $6.0 million and R&D expense of $0.3 million, reflecting increased investments to support brand growth, product development initiatives, and clinical activities.
Higher operating expenses were partially offset by a $2.0 million gain recognized during 2025 related to the settlement of royalty obligations under an agreement with Queen’s University Belfast.
Net Income was $17.4 million compared to $8.6 million for fiscal year 2024.

Basic and Diluted Earnings Per Share were $0.22 and $0.20, respectively, compared to a $0.11 for both basic and diluted earnings per share in the prior year.

Adjusted EBITDA, a non-GAAP measure, was $20.4 million, an increase of $11.9 million compared to $8.5 million for fiscal year 2024. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net income, the most directly comparable GAAP measure.

Cash Flow from Operating Activities had a net cash inflow of $13.5 million, compared to $12.1 million for fiscal year 2024 driven by improvements in net income, largely offset by increased investment in working capital, including higher inventory levels to support business growth.

Cash and cash equivalents totaled $64.8 million at December 31, 2025, compared to $44.7 million at December 31, 2024.

2026 Outlook

Net sales: Increasing between 10-15% year-over-year excluding 2025 revenue attributable to the Analytical Reference Standards and Services segment, driven primarily by e-commerce business and new strategic partnerships.
Gross margin: Slight improvement year-over-year, driven by improvements in inventory cost and product mix.
Sales & marketing: Increase in absolute dollars, but stable as a percentage of sales, driven by optimized investments to drive customer acquisition and support the launch of new verticals.
Research & development: Increase in absolute dollars, driven by investment into pharmaceutical development and continued external research initiatives.
General & administrative: $4.0 million to $5.0 million increase driven by infrastructure investments and legal expenses to support the growth of existing business and new market launches, as well as increased share-based compensation expense with the absence of credit loss recovery.
Investor Conference Call

A live webcast will be held Wednesday, March 4, 2026 at 4:30 p.m. Eastern Standard Time (1:30 p.m. Pacific Standard Time) to discuss Niagen Bioscience’s fourth quarter and fiscal year 2025 financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investor Relations section of Niagen Bioscience’s website at View Source The toll-free dial-in information for this call is 1-800-715-9871 with Conference ID: 8584242.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern Standard Time on March 4, 2026 to 11:59 p.m. Eastern Daylight Time on March 11, 2026. The replay of the call can also be accessed by dialing 1-800-770-2030, using the Replay ID: 8584242 followed by the # key.

(Press release, ChromaDex, MAR 4, 2026, View Source [SID1234663243])

On March 4, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the latest long-term survival analysis data from the China pivotal registrational Phase II study (COMPASSION-03/AK104-201) of cadonilimab as a monotherapy for patients with recurrent or metastatic cervical cancer (R/M CC) who have failed prior platinum-containing chemotherapy, were presented in a late-breaking oral presentation by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, the Principal Investigator, at the 27th European Congress on Gynaecological Oncology (ESGO 2026).

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The long-term survival data of cadonilimab monotherapy in this patient population confirms cadonilimab’s ability to convert deep tumor remission into long-term disease control and survival benefits. This study provides clinically meaningful evidence to support its use in the treatment of advanced cervical cancer, offering patients a new therapeutic option that significantly improves survival outcomes.

Best Overall Response (BOR) Analysis Demonstrates Remarkable Survival Benefit

In the updated data presented at the ESGO Congress, with a median follow-up duration of 26.5 months, a BOR-stratified analysis was conducted in all 99 efficacy-evaluable patients. This analysis further quantified the strong correlation between the depth of tumor response and long-term survival benefit associated with cadonilimab treatment.

Among all subjects who achieved a complete response (CR), the median overall survival (OS) was not reached (NR), with a 24-month OS rate of up to 100.0% (nominal p = 0.0002). The median progression-free survival (PFS) was also not reached, with a 12-month PFS rate of 84.6% (nominal p < 0.0001).

In patients achieving partial response (PR), the median OS remained unreached (NR), with a 24-month OS rate of 63% (nominal p = 0.0002). The median PFS was 11.17 months, and the 12-month PFS rate was 47.3% (nominal p < 0.0001).

The median time to response (mTTR) in the CR patients was 1.84 months, comparable to that observed in the PR patients (1.87 months). The median duration of response (mDoR) in the CR patients was not reached and was significantly longer than that in the PR patients (nominal p = 0.035).

Cadonilimab Provides Sustained Long-Term Survival Benefit Irrespective of PD-L1 Expression Status

The COMPASSION-03 study enrolled more than 18% of patients with PD-L1 CPS < 1, and 36% of participants had received ≥2 prior lines of systemic therapy. Study findings demonstrated that cadonilimab monotherapy achieved a median OS of 17.5 months (11.4, NE).

Updated long-term follow-up data showed durable survival benefit across the overall population, including both PD-L1 positive and PD-L1 negative patients, with 18-month and 24-month OS rates of 47.8% and 40.9%, respectively.

The Rising Value of a Foundational IO 2.0 Backbone

Cadonilimab, the world’s first approved cancer immunotherapy bispecific antibody that was commercially launched in 2022, has demonstrated its breakthrough clinical value across a large number of approved indications and Phase III trials. Cadonilimab addresses critical clinical gaps by benefiting cancer patients across all levels of PD-L1 expressions, earning strong recognition from clinicians and patients. Importantly, cadonilimab shows superior efficacy versus current standard of care in challenging settings like immunotherapy-resistant tumors and cold tumors that had limited response to PD-1/L1 agents.

This differentiated profile stems from its dual targeting of PD-1 and CTLA-4 with synergistic anti-tumor activity. This novel mechanism preserves the therapeutic benefits of both targets while overcoming their individual limitations. Specifically, the toxicity that restricts the clinical utility of current CTLA-4 monotherapy agents, and the poor response to PD-1/L1 agents in PD-L1 low/negative populations.

Cadonilimab is now approved for three indications in China: first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer. It is under evaluation in 11 registrational/Phase III studies across major first-line tumor indications, various cold tumors, and IO-resistant settings, including a global Phase III trial in first-line gastric cancer and a global registrational trial in IO-resistant hepatocellular carcinoma.

While advancing cadonilimab’s global clinical development independently, Akeso remains committed to open collaboration, integrating premier worldwide resources to accelerate international market access and benefit cancer patients worldwide.

(Press release, Akeso Biopharma, MAR 4, 2026, View Source [SID1234663259])

On March 4, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that Dan Schmitt, President & CEO of the Company, will present at the Citizens Life Sciences Conference in Miami Beach, FL on Tuesday, March 10, 2026, at 8:25 a.m. ET.

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The webcast of Mr. Schmitt’s presentation will be available at:

https://event.summitcast.com/view/BuMiPNPtyHKimMF6k4AFMd/guest_book?session_id=PW9gAwrMfrWWSf34Hno6ah

The Actuate management team will be available for one-on-one meetings with registered conference attendees.

A live link to the presentation will be located under "Events" in the Investors section of the Company’s website at www.actuatetherapeutics.com. A replay of the webcast will be available on Actuate’s website for 30 days following the presentation.

(Press release, Actuate Therapeutics, MAR 4, 2026, View Source [SID1234663275])

On March 4, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR (E7777, denileukin diftitox-cxdl) administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial was conducted by lead investigator, Dr. Veronika Bachanova, at the University of Minnesota and City of Hope. Full results were presented at the 2026 ASTCT & CIBMTR Tandem Meetings1.

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The Phase 1 trial was designed to augment the lymphodepletion regimen prior to CAR-T infusion through the administration of LYMPHIR to potentially improve the anti-tumor activity of CAR-T therapies. LYMPHIR, an engineered fusion toxin that preferentially binds to the IL-2 receptor expressed on regulatory T-cells (Tregs), is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after one prior systemic therapy.

"Enhancing Treg depletion prior to CAR-T infusion with LYMPHIR represents a promising immunomodulatory strategy in patients with high-risk DLBCL, and these Phase 1 data provide an encouraging signal of the potential to enhance current CAR-T regimens," said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. "These positive data support our broader strategy of exploring LYMPHIR’s modulatory effect on Tregs in combination with other approved therapies to potentially enhance the body’s own immune system to fight cancerous tumors," he added.

Topline Results & Study Design

● All patients (n=14) completed treatment and proceeded to CAR-T infusion;

● LYMPHIR was well tolerated, with no dose-limiting toxicities observed;

● No Grade ≥3 LYMPHIR-related immune adverse events or infusion reactions were reported; and,

● Data demonstrated effective Treg depletion, and promising efficacy signals of enhanced standard lymphodepletion with the use of Treg-targeting LYMPHIR.

The Phase 1, open-label, dose-escalation study (NCT04855253), enrolled 14 patients with relapsed or refractory DLBCL exhibiting poor prognostic features, including double/triple hit genetics, primary refractory disease, and extranodal involvement. Participants received one dose of LYMPHIR (E7777) at 5, 7, or 9 µg/kg followed by low dose chemotherapy prior to standard commercial CD19-directed CAR-T cell therapy. All patients received an infusion of one of the following FDA-approved, commercially manufactured CAR-T products: axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead Sciences), lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb), or tisagenlecleucel (Kymriah; Novartis).

The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.

Key Findings from the Phase 1 Trial

● Overall response rate (ORR) was 86% at one month, including 57% complete responses (CR) and 29% partial responses (PR);

● One-year progression-free survival (PFS) was 77% (95% CI: 43–92%);

● One-year overall survival (OS) was 84% (95% CI: 49–96%);

● A single LYMPHIR dose resulted in depletion of circulating Tregs in all but one patient;

○ Median reduction of 24 Tregs/µL (range 8–65);

○ Treg nadir was observed 24 hours post-LYMPHIR;

● LYMPHIR was well tolerated with no dose-limiting toxicities (DLTs) observed up to 9 µg/kg; and,

● Reported adverse events included manageable Grade 1–2 capillary leak syndrome, fever, and transient liver enzyme elevations; Grade 3 cytopenias were consistent with expected lymphodepletion. CAR-T related cytokine release syndrome (CRS) occurred in 43% of patients (all Grade 1/2), and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 21% (primarily low grade).

"In this high-risk population, LYMPHIR showed a favorable safety profile and promising pharmacodynamic effects when administered prior to CAR-T therapies. This data sets the stage for a larger study to assess its potential to enhance CAR-T efficacy through longer duration of LYMPHIR use," said Dr. Veronika Bachanova, Principal Investigator and Professor of Medicine at the University of Minnesota.

Dr. Bachanova presented the topline data at the 2026 Tandem Meetings | ASTCT CIBMTR.

Title: E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T for High-Risk LBCL

Presentation ID: 677608

Abstract ID: 296369

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for approximately 30%–40% of newly diagnosed cases in the United States. DLBCL is an aggressive and rapidly growing cancer of B lymphocytes, a type of white blood cell responsible for producing antibodies. While frontline chemoimmunotherapy regimens such as R-CHOP can be curative for many patients, up to 40% experience relapse or refractory disease. High-risk features are associated with poor outcomes and limited responses to standard therapies, including CAR-T cell therapy. Novel strategies that modulate the tumor microenvironment, such as transient regulatory T-cell depletion, are under investigation to improve treatment efficacy and long-term remission rates in this difficult-to-treat population.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Pharmaceuticals, MAR 4, 2026, View Source [SID1234663244])

On March 4, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company advancing breakthrough therapies for diseases, reported the deployment of the OpenAI API to support IND-enabling development of HT-KIT, its orphan-designated therapy targeting rare and aggressive KIT-driven cancers.

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The OpenAI-powered API platform has been integrated into the HT-KIT development workflow to support preclinical data analysis, molecular modeling of KIT-driven pathways, and preparation of regulatory documentation ahead of IND submission.

HT-KIT results below have shown success in rare cancers

Potent gene-level target suppression: HT-KIT achieved >80% reduction of KIT mRNA/protein across in-vitro systems and in vivo models of systemic mastocytosis and GIST.

Favorable tolerability in early studies: No dose-limiting toxicities observed in the reported preclinical work to date.

Rapid anti-tumor activity: In xenograft models, statistically significant tumor-volume reduction by Day 8 was observed, accompanied by apoptotic signaling consistent with KIT pathway knock-down.

Bioanalytical readiness: GLP-validated bioanalytical methods completed to support pharmacokinetic, biodistribution, and exposure-response analyses for IND.

HT-KIT is advancing toward Investigational New Drug (IND) submission and Phase 1 clinical evaluation.

HT-KIT has received Orphan Drug Designation and is designed to address cancers driven by KIT mutations, an area of significant unmet medical need.

"Hoth’s integration of OpenAI’s API supports execution of our IND-enabling strategy for HT-KIT as we advance toward Phase 1," said Robb Knie, Chief Executive Officer.

(Press release, Hoth Therapeutics, MAR 4, 2026, View Source [SID1234663260])