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 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 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2025, and provided a corporate update.

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"2025 was a productive year for Cellectar, marked by disciplined execution across our pipeline and meaningful clinical, regulatory, and operational achievements," said James Caruso, president and CEO of Cellectar. "We advanced iopofosine I-131 toward its planned mid-2026 Conditional Marketing Authorization (CMA) submission in Europe, supported by a strong clinical dataset and productive dialogue with both the European and U.S. regulatory agencies. In parallel, we continued to shape the future of our radiotherapeutic platform with the initiation of our Phase 1b CLR 125 study in triple negative breast cancer and strengthened our supply chain and intellectual property estate."

"As we look ahead to 2026, our momentum is building. We expect important clinical readouts, continued regulatory progress, and expansion of our next-generation Phospholipid Drug Conjugate (PDC) programs. We remain focused on executing with excellence, communicating transparently, and delivering meaningful therapeutic advances for patients with difficult-to-treat cancers," added Mr. Caruso.

2025 and Recent Corporate Highlights

Iopofosine I 131, the Company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Following advice from the European Medicines Agency’s (EMA) Scientific Advice Working Party (SAWP), the Company plans to submit a CMA for iopofosine I 131 as a treatment for in Waldenström Macroglobulinemia (WM). The CMA submission will be supported by data from the CLOVER WaM study, including 12-month follow-up on all patients, updated overall and major response rates, progression-free survival, duration of response, and compelling subset analyses on post-BTKi patients.
Received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for iopofosine I 131 in relapsed/refractory WM.
Received recommendation from the FDA to investigate iopofosine I 131 as a treatment option in post-BTKi indications as early as the second line, substantially expanding the available patients in the U.S. market.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors
Initiated a Phase 1b study of CLR 125 in Triple Negative Breast Cancer (TNBC).
CLR 125 has been well tolerated in vivo with no signs of end-organ toxicity, including hematologic toxicity, and has also demonstrated reduction or inhibition of solid tumors in preclinical studies.
Enrollment is ongoing in the Phase 1b dose finding study of CLR 125, which will evaluate three doses of 32.75 mCi/m2/dose for up to 4 cycles, 62.5 mCi/m2/dose for up to 3 cycles and 95 mCi/m2/dose for up to 2 cycles in patients with relapsed TNBC.
The study’s primary endpoint is to determine a recommended Phase 2 dose and to evaluate safety, tolerability and initial response assessment (RECIST v1.1 and PFS).
Secured a supply agreement with Ionetix to provide commercial-scale supply of cGMP-grade Actinium-225 (Ac-225) and Astatine-211 (At-211) to support ongoing CLR 225 clinical development programs.
Corporate
Strengthened and expanded the Company’s global intellectual property estate with newly issued patents across Europe, Asia-Pacific, the Middle East and the Americas. The expanded IP coverage protects both iopofosine I 131 as well as the broader radiotherapeutic pipeline, including CLR 125.

2025 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2025, the company had cash and cash equivalents of $13.2 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of December 31, 2025, is adequate to fund its basic budgeted operations into the third quarter of 2026.
Research and Development Expenses: R&D expenses for the year ended December 31, 2025, were approximately $11.5 million, compared to approximately $26.1 million for the year ended December 31, 2024. The decrease was primarily a result of reduced activity in our CLOVER WaM clinical study, as we were exclusively in patient follow-up during 2025. Additionally, manufacturing costs declined as we completed development of a fully redundant production and logistics pipeline.
General and Administrative Expenses: G&A expenses for the year ended December 31, 2025, were approximately $11.5 million, compared to approximately $25.6 million for the same period in 2024. The decrease was primarily a result of reduced pre-commercialization efforts and related personnel.
Other income and expense: Other income and expense, net, was approximately $1.2 million of income in 2025, as compared to approximately $7.3 million of income in the prior year. These amounts are almost exclusively a result of non-cash impacts from the cost to issue and in the valuation of certain warrants that are considered liabilities.
Net Loss: Net loss for the full year ending December 31, 2025, was $21.8 million or $8.35 per basic and diluted share, compared with $44.6 million or $36.52 per basic share and $41.89 per diluted share during 2024.

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, March 4, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, MAR 4, 2026, View Source [SID1234663242])

On March 4, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) – AIM ImmunoTech Inc. ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of its lead product, Ampligen (rintatolimod), for the treatment of late-stage pancreatic cancer – a lethal and unmet global health problem – reported the preliminary results of its previously announced rights offering (the "Rights Offering") which expired at 5:00 p.m., Eastern Time, on March 3, 2026. The Company estimates that the Rights Offering will result in total subscriptions of approximately $1.8 million. The results of the Rights Offering are preliminary and subject to change pending finalization and verification by the Company and its subscription agent, Broadridge Corporate Issuer Solutions, LLC.

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Each right entitled the holder to purchase one unit ("Unit"), at a subscription price of $1,000 per Unit, consisting of one share of the Company’s Series G Convertible Preferred Stock (the "Preferred Stock"), and 2,000 Class G Common Stock Purchase Warrants to purchase the Company’s Common Stock (the "Warrants").

The Company anticipates the closing of the Rights Offering will occur on or about March 6, 2026, subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book-entry form or through the facilities of DTC, as applicable, shares of the Preferred Stock and Warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders.

Maxim Group LLC acted as dealer-manager for the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

The Company’s registration statement on Form S-1 (Registration No. 333-292085) was declared effective by the Securities and Exchange Commission ("SEC") on February 10, 2026. The prospectus relating to and describing the terms of the Rights Offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, AIM ImmunoTech, MAR 4, 2026, View Source [SID1234663241])

On March 4, 2026 Denovicon Therapeutics, Inc. reported the discovery of DNT-1569, a small molecule inhibitor of poly(ADP-ribose) polymerase 7 (PARP7) designed as a potential oral immunomodulatory therapy for solid tumors. To the best of our knowledge, no small molecule immuno-oncology drug has reached the market — the entire immunotherapy revolution to date relies on biologics. DNT-1569 is designed to change that. The compound demonstrates potent PARP7 inhibition with approximately 2,000-fold selectivity over PARP1 and 2,500-fold selectivity over PARP2 — a selectivity profile that distinguishes it from all known PARP7 inhibitors, including the clinical compound RBN-2397 (atamparib).

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Why PARP7 — and Why Selectivity Matters
After nearly 25 years in drug discovery — including 17 years at Johnson & Johnson, where I co-led seven clinical candidates — one pattern stands out: good mechanisms fail when the molecules carrying them aren’t clean enough to dose properly.

PARP7 is a compelling immuno-oncology target. Inhibiting PARP7 restores type I interferon signaling in tumor cells, activating the innate immune system and potentially converting immunologically "cold" tumors — the ones that don’t respond to checkpoint inhibitors like Keytruda — into "hot" tumors that the immune system can recognize and attack. PARP7 is dysregulated across multiple solid tumor types, including lung, breast, ovarian, head and neck, pancreatic, and colorectal cancers.

The clinical precedent exists. Ribon Therapeutics’ RBN-2397 entered Phase 1 trials and demonstrated preliminary antitumor activity, establishing proof of concept that PARP7 inhibition produces clinical benefit. But RBN-2397 is not a selective PARP7 inhibitor — it potently inhibits PARP1 and PARP2 as well, which creates the same hematological toxicities seen with traditional PARP inhibitors. This likely resulted in tox-limited dosing and, consequently, the achievable efficacy.

The mechanism is validated. The selectivity problem was not.

DNT-1569: Solving the Selectivity Problem
DNT-1569 was designed to be the PARP7 inhibitor that RBN-2397 was not — one that inhibits the intended target without carrying off-target PARP1/2 liabilities.

Biochemical Profile:

DNT-1569 (Denovicon) RBN-2397 (Ribon)
PARP7 4 nM 3 nM
PARP1 8,000 nM 37 nM
PARP2 10,000 nM 17 nM
PARP1 Selectivity ~2,000× ~12×
PARP2 Selectivity ~2,500× ~6×
Scaffold Novelty Tanimoto = 0.14 vs. RBN-2397 —
Virtual Design Time < 2 days Years (traditional)
DNT-1569 matches RBN-2397’s PARP7 potency while pushing PARP1 and PARP2 activity into the micromolar range. This selectivity profile is designed to enable full therapeutic dosing of PARP7 without the PARP1/2-driven toxicities that likely constrained RBN-2397’s clinical performance.

Importantly, DNT-1569 sits on a novel chemical scaffold — a Tanimoto similarity of 0.14 relative to RBN-2397 confirms that this is not an analogue or derivative of existing PARP7 chemistry. The compound emerged from an entirely different design process, not from iterating on a known scaffold.

How We Got Here
DNT-1569 was designed using Denovicon’s computational drug discovery platform, which uses physics-based machine learning to design molecules with druglike properties built in from the start — not optimized after the fact.

Rather than starting with target affinity and then spending years trying to engineer in druglike properties — the traditional break-fix cycle that accounts for the majority of preclinical program failures — our approach optimizes across ADMET, pharmacokinetic, toxicity, and affinity properties from the outset. Every design decision maps to real chemical features that medicinal chemists can interrogate — no black boxes.

The entire virtual design phase for DNT-1569 was completed in under two days. The program from inception to the selectivity data reported here took under one year.

Since the DNT-1569 program, Denovicon’s platform has evolved into a quantum physics-driven generative AI architecture that extends these capabilities to trillion-molecule chemical spaces, enabling simultaneous multi-objective optimization in a single computational step. The core principle remains the same: build druglikeness in by design. The scale and speed at which we can now do it has fundamentally changed.

Clinical Implications
The immuno-oncology landscape is dominated by biologics — checkpoint inhibitors, CAR-T therapies, bispecific antibodies — all of which require infusion, cold chain logistics, specialized administration, and carry substantial cost. To the best of our knowledge, there is no marketed small molecule immuno-oncology drug. DNT-1569 is designed to address that gap: an oral small molecule that modulates the immune system’s ability to recognize and attack tumors.

A truly selective small molecule PARP7 inhibitor opens two therapeutic paths.

Monotherapy: If PARP7 inhibition alone is sufficient to drive antitumor immunity in selected patient populations — as early evidence in squamous cell lung cancer and head and neck cancers suggests — a selective oral PARP7 inhibitor could offer meaningful clinical benefit without the toxicity burden of pan-PARP inhibition. As a small molecule, it reaches compartments that antibodies cannot — including the central nervous system — and can be manufactured and distributed at a fraction of the cost of biologics.

Combination therapy: The greater opportunity may lie in combining a selective PARP7 inhibitor with existing immune checkpoint inhibitors. Approximately 70% of cancer patients do not respond to checkpoint inhibitors alone, largely because their tumors are immunologically cold. A selective PARP7 inhibitor that activates the type I interferon pathway — turning cold tumors hot — could serve as an oral immunomodulatory backbone for checkpoint inhibitor combinations. Critically, this combination is viable only if the PARP7 inhibitor does not add significant toxicity to the regimen. DNT-1569’s selectivity profile is designed to make that combination feasible.

An oral, well-tolerated small molecule immunomodulator would represent a new therapeutic modality — one with implications not just for efficacy, but for global patient access.

What Comes Next
Immune biomarker assays for DNT-1569 are underway. These data will provide the first readout on whether the selectivity advantage observed in biochemical assays translates to the expected immunomodulatory activity in cellular systems. Denovicon is actively engaging pharmaceutical partners for proof-of-concept collaborations around the PARP7 program and the broader quantum physics-driven generative AI platform.

(Press release, Denovicon Therapeutics, MAR 4, 2026, View Source [SID1234663214])