HyBryte™ Treatment Results to be Presented at US Cutaneous Lymphoma Consortium Annual Workshop 2026

On March 23, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that findings from recent supportive trials with HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) are being presented at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop (March 26, 2026), which precedes the American Academy of Dermatology (AAD) Annual Meeting. Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania, who was the Principal Investigator for the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study as well as the ongoing Phase 3 FLASH2 study, will present at the USCLC. Dr. Kim will detail positive results from the recently completed investigator-initiated study using HyBryte as a long-term treatment of CTCL. A poster also will be presented at the conference sharing the positive results of a study evaluating HyBryte versus Valchlor (mechlorethamine) conducted by Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study. The official conference program can be found here.

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Oral Presentation:

Title: Phase 2 Investigator-Initiated Real-World Study Evaluating Topical Hypericin Ointment Photodynamic Therapy for Early-Stage Mycosis Fungoides/CTCL (RW-HPN-MF-01) presented by Dr. Ellen Kim, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania.

Poster Presentation:

Title: Results from a Pilot Study of HyBryte (topical synthetic hypericin) versus Valchlor (mechlorethamine) in the Treatment of CTCL attended by Dr. Christopher Pullion, Medical Director, Soligenix, Inc.

The poster and presentation review the Company’s findings in recent supportive studies, which have demonstrated the clinical benefits of longer treatment times (Study RW-HPN-MF-01; investigator-initiated study), as well as HyBryte’s relative efficacy and tolerability compared to Valchlor (Study HPN-CTCL-04).

About the USCLC Workshop

The United States Cutaneous Lymphoma Consortium is a multidisciplinary society of physicians which use collaborative research and education to improve the quality of life and prognosis of patients with cutaneous lymphoma. This workshop is held annually to facilitate collaboration. The meeting website is available here.

About the AAD Annual Meeting

The American Academy of Dermatology Association Annual Meeting is one of the largest dermatologic scientific meetings globally and is attended by both researchers and dermatologists. The meeting website is available here.

About HyBryte

HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the modified Composite Assessment of Index Lesion Severity [mCAILS] score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, has successfully achieved its first safety review milestone with a pre-specified, blinded interim analysis expected to be completed in 2Q2026. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte’s increased effect over a more prolonged, "real world" treatment course. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte patients from the FLASH study. Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study was initiated. At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback.

Additional supportive studies have demonstrated the utility of longer treatment times (Study RW-HPN-MF-01), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor (Study HPN-CTCL-04).

In addition, the FDA awarded an Orphan Products Development grant to support the investigator-initiated study evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER [Surveillance, Epidemiology, and End Results] data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS [European Cancer Information System] prevalence estimates, with approximately 3,800 new cases annually).

(Press release, Soligenix, MAR 23, 2026, View Source [SID1234663832])

Sutro Biopharma Reports Full Year 2025 Financial Results and Business Highlights

On March 23, 2026 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the full year 2025 and recent business highlights.

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"2026 is poised to be a pivotal year, propelled by disciplined clinical execution and initial data that we believe will showcase the vast potential of our proprietary ADC platform," said Jane Chung, Sutro’s Chief Executive Officer. "We recently completed dosing the third cohort in the Phase 1 trial of STRO-004, our potential best-in-class Tissue Factor ADC, and look forward to reporting initial data mid-year. In parallel, we are advancing STRO-006, our ITGB6 ADC, and accelerating STRO-227, our wholly owned dual-payload program targeting PTK7, toward IND submission this year. In addition, patient dosing has commenced under our collaboration with Astellas Pharma for our first partnered dual-payload iADC — marking the first dual-payload program from Sutro’s platform to enter the clinic. Supported by our recent financing, continued financial stewardship, and sharpened strategic focus, we believe we are well positioned to execute across all our programs and deliver differentiated ADCs with best-in-class potential that could redefine standards of care in oncology."

Wholly Owned Pipeline

STRO-004: The Company has completed dosing across three cohorts in the first-in-human Phase 1 trial evaluating STRO-004, a DAR8 Topo1 ADC targeting Tissue Factor (TF), with potential as best-in-class TF ADC. Initial clinical data are expected in mid-2026, including safety and tolerability. Sutro also expects to share pharmacokinetic exposure and potentially early signs of activity. In non-human primate studies, STRO-004 demonstrated a favorable preclinical safety profile, with a highest non-severely toxic dose (HNSTD) of 50 mg/kg — supporting a clinical starting dose of 1mg/kg.

STRO-006: A highly selective, DAR 8 Topo1 ADC targeting integrin β6 (ITGB6), STRO-006 is expected to enter clinical development in 2026 for the treatment of multiple solid tumors.

STRO-227: Sutro’s PTK7-targeting dual-payload ADC program, consisting of MMAE (DAR2) and Topo1 (DAR8), remains on track, with an IND submission targeted for 2026.

Next-Generation ADC Collaborations

Astellas: Two research and development programs are progressing under Sutro’s collaboration with Astellas focused on dual-payload immunostimulatory ADCs (iADCs).


The first program, targeting TROP2, has entered the clinic and is actively dosing patients, triggering a $10 million milestone payment with receipt expected in the second quarter of 2026.

The second program entered an IND-enabling toxicology study in the fourth quarter of 2025, triggering a $7.5 million milestone payment to Sutro.

Upcoming and Recent Industry/Medical Conferences

American Association for Cancer Research (AACR) (Free AACR Whitepaper), April 17-22, 2026, San Diego California


Sutro’s strategic partner, Astellas Pharma, will present preclinical results from its TROP2-targeted iADC program in an oral presentation on Sunday, April 19, 2026 at 4:35-4:50 PM PT. The presentation, titled "ASP2998, a TROP2-targeted immunostimulatory antibody-drug conjugate (iADC) with dual payloads, demonstrates potent efficacy and a favorable safety profile in nonclinical models," highlights progress in the development of next-generation iADCs leveraging Sutro’s cell-free protein synthesis platform.

Additionally, Sutro will present an oral presentation and multiple posters highlighting advances across its ADC pipeline and discovery platforms at AACR (Free AACR Whitepaper). The presentation details are as follows:
o
Presentation: "STRO-004, an exatecan-based next-generation tissue factor (TF)-targeted ADC, demonstrates superior efficacy across TF-expressing solid tumors in a comprehensive single-mouse PDX trial"

Presentation Date and Time: Sunday, April 19, 2026; 4:35-4:50 PM PT
o
Poster: "Phase 1 open-label study to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in adults with refractory/recurrent metastatic solid tumors"

Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
o
Poster: "STRO-006: An Integrin beta-6–targeting ADC demonstrates favorable safety profile and potent antitumor activity in preclinical solid tumors"

Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
o
Poster: "Preclinical characterization of STRO-227: A PTK7-targeting dual-payload ADC with topoisomerase 1 and tubulin inhibitors"

Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
o
Poster: "The HER2-targeting dual-payload antibody-drug conjugate combining a topoisomerase I inhibitor and a microtubule inhibitor demonstrates superior efficacy and overcomes resistance to single-payload ADCs in xenograft models"

Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
o
Poster: "Sutro’s Site-Specific Dual-Payload ADCs Combining TOPO1i and DNA Damage Response Inhibitors to Enhance Efficacy, Overcome Resistance, and Improve Safety"

Session Date and Time: Tuesday, April 21, 2026; 9:00 AM-12:00 PM PT

16th World ADC London Summit, February 23-26, 2026, London, UK


Sutro participated in a plenary and two panel discussions at the conference, covering topics including dual-payload innovation, key drivers of ADC differentiation, and ADC collaborations. For more details, read the full press release here.

Corporate Updates


Sutro strengthened its cash position with an underwritten offering of 7,868,383 shares of its common stock at a price of $13.98 per share, resulting in gross proceeds of $110.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. The Company’s cash runway is now expected into at least the second quarter of 2028, excluding additional anticipated milestones from Sutro’s existing collaboration.

Sutro management, joined by KOL Anthony Tolcher, M.D., FRCPC, FACP, hosted a virtual R&D Day on Wednesday, November 12, highlighting the Company’s platform innovations and next-generation ADC pipeline. Key updates included the initiation of the Phase 1 study with STRO-004 and the selection of PTK7 as the target for its initial dual-payload candidate, STRO-227.

Full Year 2025 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2025, Sutro had cash, cash equivalents and marketable securities of $141.4 million, as compared to $167.6 million as of September 30, 2025. With gross proceeds from the recent financing totaling $110.0 million, the Company’s cash runway is expected into at least the second quarter of 2028, excluding anticipated milestones from Sutro’s existing collaborations.

Revenue

Revenue was $102.5 million for the year ended December 31, 2025, as compared to $62.0 million for the year ended December 31, 2024, with the 2025 amount related principally to the Astellas and Ipsen collaborations. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Research & Development (R&D) and General & Administrative (G&A) Expenses

Total R&D and G&A expenses for the year ended December 31, 2025 were $207.4 million, as compared to $300.5 million for the year ended December 31, 2024. The 2025 year includes non-cash expenses for stock-based compensation of $14.0 million and depreciation and amortization of $7.3 million, as compared to $24.7 million and $7.2 million, respectively, in the comparable 2024 period.

Restructuring Costs

The total cash payments and costs related to the further operational restructuring announced on September 29, 2025 are estimated to be approximately $4.1 million to $4.3 million, with a majority of these amounts paid in the fourth quarter of 2025. These estimates are subject to a number of assumptions and actual results may differ. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the corporate restructuring.

(Press release, Sutro Biopharma, MAR 23, 2026, View Source [SID1234663834])

Senti Biosciences to Present Clinical and Translational Data on SENTI-202 at the 11th Annual Innate Killer Conference

On March 23, 2026 Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported upcoming presentations featuring clinical and translational data from its SENTI-202 program at the 11th Annual Innate Killer Conference, taking place March 24–25, 2026 in San Diego, California.

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The presentations will include data from the ongoing Phase I clinical trial of SENTI-202, a first-in-class, off-the-shelf, logic-gated CAR NK cell therapy designed to selectively target CD33 and/or FLT3 while sparing EMCN-expressing healthy cells in adults with relapsed/refractory acute myeloid leukemia (AML).

The presentations details are as follows:

Clinical Data Presentation
Rochelle Emery, MD, Medical Director at Senti Bio, will present:
"Promising Phase I Clinical Trial Results from SENTI-202-101, a First-in-Class, CD33 and/or FLT3 & not EMCN, Selective Off-the-Shelf Logic Gated CAR NK Cell Therapy in Adults with R/R AML"

The presentation will highlight clinical data from the ongoing study evaluating the safety and preliminary anti-leukemic activity of SENTI-202.

Translational and Correlative Data Presentation
Enping Hong, PhD, Associate Director of Preclinical and Translational Science, will present:
"Promising Phase I Correlative SENTI-202 Data is Consistent with Clinical Activity & Unique Logic Gated Mechanism of Action"

The presentation will provide correlative analyses supporting observed clinical activity and the therapy’s logic-gated mechanism of action.

Workshop Participation
Brian Garrison, PhD, Vice President of Research and Translational Science, will lead a workshop titled:
"Harnessing Biomarker Discovery & Translational Tools to Accelerate NK Therapy Clinical Success"

The workshop will focus on strategies to advance NK cell therapy development through biomarker discovery and translational approaches.

(Press release, Senti Biosciences, MAR 23, 2026, View Source [SID1234663851])

Tempest Therapeutics Announces Up To $6 Million Private Placement

On March 23, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) (the "Company"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 925,927 shares of common stock (or pre-funded warrant in lieu thereof), series A warrants to purchase up to 925,927 shares of common stock and short-term series B warrants to purchase up to 925,927 shares of common stock, at a combined purchase price of $2.16 per share of common stock (or $2.159 per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement. The series A warrants and the short-term series B warrants will have an exercise price of $2.16 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants (the "Stockholder Approval Date"). The series A warrants will expire five years from the later of the Stockholder Approval Date and the Effectiveness Date (as defined below) and the short-term series B warrants will expire twenty-four months from the later of the Stockholder Approval Date and the Effectiveness Date. The private placement is expected to close on or about March 23, 2026, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $2 million, prior to deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A warrants and the short-term series B warrants, if fully exercised on a cash basis, will be approximately $4 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the securities issued in the private placement and shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date").

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Tempest Therapeutics, MAR 23, 2026, View Source [SID1234663835])

ORYZON Announces U.S. Patent Grant Covering Iadademstat Combinations with Venetoclax

On March 23, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, reported that the United States Patent and Trademark Office (USPTO) has granted U.S. patent US12,564,559 B2, relating to therapeutic combinations of iadademstat, Oryzon’s potent and selective LSD1 inhibitor currently in clinical development in oncology and hematology.

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The granted patent includes claims covering methods of treating neoplastic diseases, including acute myeloid leukemia (AML), using combinations comprising iadademstat and other therapeutic agents, notably including venetoclax, a backbone therapy in the current standard of care for first-line acute myeloid leukemia.

The patent is expected to expire in January 2039, including 681 days of patent term adjustment (PTA) granted by the USPTO to compensate for delays during patent prosecution. This does not include any potential patent term extension related to regulatory review, which could further extend the patent term.

Iadademstat is currently being evaluated in seven ongoing oncology clinical trials, including the Phase Ib ALICE-2 study in first-line AML in combination with venetoclax and azacitidine. Highly encouraging preliminary data from this trial were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting, showing a 100% overall response rate (ORR) and a 90% strict complete remission (CR) rate. The trial continues to enroll rapidly, and updated data from approximately 15-16 patients (around 75% of the planned enrollment), are expected to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (EHA) (Free EHA Whitepaper) in June 2026.

"This U.S. patent grant represents a significant addition to our growing IP portfolio for iadademstat," said Neus Virgili, Oryzon’s Chief IP Officer. "This patent covers combinations with venetoclax, the current standard of care in first-line AML, and provides protection extending into 2039, strengthening the long-term value of our clinical programs."

In addition to this U.S. patent, Oryzon has obtained patent protection for combinations of iadademstat with venetoclax, or their use in the treatment of cancer, in Australia, Brazil, Canada, Europe, India, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, and Russia. Additional patent applications are pending in other jurisdictions. Oryzon also holds granted patents covering combinations of iadademstat with other AML therapies, including azacitidine and decitabine, in the United States and other countries.

(Press release, Oryzon, MAR 23, 2026, View Source [SID1234663852])