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])

On March 23, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV)(FSE: 7JO0), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported that two research abstracts have been accepted for presentation at the upcoming 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22 in San Diego, California.

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The AACR (Free AACR Whitepaper) Annual Meeting is a global forum for cancer research, where the world’s leading scientists, clinicians, and biotech innovators gather to unveil next-generation oncology breakthroughs. Rakovina’s acceptance to present highlights growing recognition for its work at the intersection of AI technology and precision cancer therapy.

From AI Design to Delivery: Advancing Novel DDR Therapies for Hard-to-Treat Cancers

Rakovina will present two abstracts at the meeting. The first abstract: A Novel Brain-Penetrant Dual ATR-mTOR Inhibitor for PTEN-Deficient Cancers, presents the use of the Enki generative AI platform to design first-in-class CNS-penetrating molecules that simultaneously inhibit ATR and mTOR, two key drivers of survival in PTEN-deficient cancer cells. PTEN deficiency is found in up to 40% of gliomas and up to 63% of breast cancers, which frequently metastasize to the brain, yet no approved therapy directly addresses this dual vulnerability. Using the Enki latent diffusion model to simultaneously optimize potency, selectivity, CNS penetrance, and ADMET properties in collaboration with Variational AI (Vancouver, BC), the team identified and synthesized promising dual inhibitor candidates, with data on efficacy and pharmacokinetics to be presented at the meeting.

Title: A novel brain-penetrant dual ATR-mTOR inhibitor for PTEN-deficient cancers
Date/Time: April 20, 2026 / 9:00 AM – 12:00 PM
Session Category: Experimental and Molecular Therapeutics
Session: DNA Damage and Repair 2
Abstract Number: 5034

The second abstract: Development of a Lipid Nanoparticle Formulation of the Bifunctional PARP and HDAC Inhibitor Kt-3283, presents preclinical development work on kt-3283, Rakovina’s bifunctional compound that simultaneously inhibits PARP and HDAC enzymes, eliminating the need for combination drug regimens and their associated toxicity risks.

In vitro studies with kt-3283 have demonstrated highly potent anti-tumor activity across multiple tumor types, supporting its potential as a differentiated therapeutic candidate. This abstract presents a novel advancement: encapsulation of kt-3283 into patterned lipid nanoparticles (pLNPs) designed using the EnsaliX AI platform, developed in collaboration with NanoPalm (Riyadh, Saudi Arabia). The pLNP/kt-3283 formulation is designed to enhance encapsulation efficiency, improve cell uptake, and optimize pharmacological performance to support clinical translation.

Title: Development of a lipid nanoparticle formulation of the bifunctional PARP and HDAC inhibitor kt-3283
Date/Time: April 21, 2026 / 2:00 PM – 5:00 PM
Session Category: Chemistry
Session: Drug Delivery
Abstract Number: 4665

"We are thrilled that for the second year in a row, we are presenting two abstracts at the AACR (Free AACR Whitepaper) Annual Meeting, an important stage for cancer research," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "These programs reflect the breadth and ambition of what our team is building. From improving how we deliver our molecules into the body, to designing entirely new inhibitors that can reach tumors in the brain, we are using AI to solve problems that have held back cancer drug development for years. We look forward to sharing our findings with the global oncology community in San Diego."

The company’s integration of AI platforms allows the evaluation of billions of potential compounds at 100x the speed of traditional methods. These innovations are further supported by Rakovina’s access to the University of British Columbia’s state-of-the-art wet lab infrastructure, enabling rapid in-house testing and optimization.

"What makes these two programs particularly exciting is that they address cancer from two distinct but complementary angles, one focused on smarter delivery of a proven bifunctional compound, and one on designing entirely new molecules to reach tumors that current therapies simply cannot access," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics.

Rakovina is driving innovation in a space projected to reach $18 billion annually by 2030. The company’s preclinical pipeline is focused on therapies that target DNA-repair vulnerabilities present in up to 75% of solid tumors, with an emphasis on hard-to-treat cancers such as breast, ovarian, prostate, and brain cancers. With AACR (Free AACR Whitepaper) presentations underway in Q2, the Company is targeting several near-term milestones across its pipeline, including in vivo testing of its new LNP formulations under the kt-3000 program, advancement of a lead in the kt-5000AI program through iterative AI-driven compound refinement and initiation of pharma partnership discussions as pipeline data matures. Rakovina expects these catalysts to meaningfully de-risk its programs and support its path toward IND-enabling studies.

(Press release, Rakovina Therapeutics, MAR 23, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-present-new-data-at-the-aacr-annual-meeting-2026-worlds-premier-cancer-research-forum [SID1234663831])

On March 23, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported a business update, and announced financial results for the year and quarter ended December 31, 2025.

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"The completion of target enrollment in the Phase 1 monotherapy study of MICVO in patients with recurrent/metastatic head and neck squamous cell carcinoma is an important milestone for the Company and reflects the incredible effort of the Pyxis Oncology team," said Thomas Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "We are laser focused on clinical execution and operations so that we can deliver a robust dataset in mid-2026 that will allow us to further assess the potential of MICVO as monotherapy. Following the preliminary results shared last December, we implemented a modified weight-based dosing approach that is expected to deliver optimal drug exposure for patients across all weight ranges to further improve the benefit-risk profile for MICVO. We look forward to sharing these results mid-year, and plan to provide an assessment of whether the dosing modification achieved these intended goals. We also expect to share updated combination data in 2H26 as we continue to evaluate the potential of MICVO in the front-line setting, building on the encouraging initial combination data shared last December."

Pipeline Updates

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Pyxis Oncology announced positive preliminary data for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in December 2025.
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Monotherapy: 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) observed with MICVO as monotherapy in 2L+ R/M HNSCC (N=13, efficacy evaluable). MICVO as monotherapy was generally well tolerated, with no Grade 4 ADC payload treatment-related adverse events (TRAEs) of interest observed. No Grade 5 events occurred. Preliminary results shared in December 2025 included all Phase 1 patients (N=18) dosed at 5.4 mg/kg IV Q3W total body weight (TBW).
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Combination: 71% confirmed ORR and 100% DCR observed with MICVO in combination with a fixed dose of 200 mg of KEYTRUDA (pembrolizumab) in 1L/2L+ R/M HNSCC at 3.6 mg/kg (N=4) and 4.4 mg/kg (N=3) IV Q3W. MICVO in combination with KEYTRUDA was generally well tolerated, with no Grade 3 or Grade 4 ADC payload TRAEs of interest observed. No Grade 5 events occurred. The combination study is part of a Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).
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During the fourth quarter of 2025, the Company obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC.
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Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC mid-year 2026.
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The ongoing MICVO Phase 1 monotherapy study is a two-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2, a dose expansion study at 5.4 mg/kg IV Q3W in 2L+ R/M HNSCC, is currently ongoing.
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The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum & anti-PD(L)-1 experienced patients (Arm 1) and post EGFRi and/or anti-PD(L)-1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment of n=~40 was completed in 1Q26.
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MICVO Phase 1 monotherapy data in 2L+ R/M HNSCC expected mid-year 2026 will include patients dosed at 5.4 mg/kg IV Q3W with a dose cap for patients with higher body weight, in addition to patients previously treated at 5.4 mg/kg IV Q3W TBW. Results are anticipated to include detailed analyses of the impact of the modified weight-based dosing approach on safety and efficacy. Adjusted Ideal Body weight (AIBW) dosing, which has demonstrated improved tolerability without sacrificing activity in clinical studies of other ADCs[1], is being implemented in ongoing clinical studies as well.
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In the preliminary results shared in December 2025, there were no treatment-related adverse events (TRAEs) leading to discontinuation for patients at or below adjusted ideal body weight. Grade 3 auristatin ADC payload related TRAEs of interest were more frequent for high body weight[2] patients and TRAEs leading to discontinuation occurred exclusively in high body weight patients.
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New PK simulation data presented in the Pyxis Oncology March 2026 corporate presentation and its 2025 Form 10-K show that modified weight-based dosing approaches, dose capping and AIBW, result in a decrease in drug exposure (Cavg) relative to TBW dosing, specifically for higher body weight patients. This reduction in exposure is expected to decrease the incidence and severity of auristatin ADC payload related TRAEs of interest and TRAEs leading to discontinuation, while preserving efficacy. Comparable drug exposure is predicted for dose capping and AIBW across all weight categories, including for higher body weight patients.
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Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and KEYTRUDA for 1L/2L+ R/M HNSCC patients in 2H26.
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The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA is currently in dose escalation across multiple doses for the treatment of 1L/2L+ R/M HNSCC. Preliminary positive results were shared in the December 2025 data update.
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Pyxis Oncology presendted new translational data in October 2025 in two posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 and in six posters at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, as well as three clinical trial posters at ESMO (Free ESMO Whitepaper). The presentation posters at ESMO (Free ESMO Whitepaper) and AACR (Free AACR Whitepaper)-NCI-EORTC provided deeper insights into the pharmacodynamic responses of tumors to MICVO as well as MICVO’s unique mechanism of action and its potential to exert anti-tumor activity through three mechanisms: direct tumor cell killing, bystander killing and immunogenic cell death.
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In April 2026, Pyxis Oncology will present novel preclinical data at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The study abstract highlights the anti-tumor activity of a murine analog of MICVO (maMICVO) in the poorly immunogenic, immunotherapy-refractory mouse oral carcinoma 2 (MOC2) syngeneic HNSCC model. Notably, image analysis suggested modulation of the immune landscape post-maMICVO treatment, providing scientific rationale to test the combination of maMICVO with anti-PD-1 in this refractory model.

Corporate Updates

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Pyxis Oncology continues to build out its senior leadership team and internal capabilities:
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Pyxis Oncology announced the appointment of Thomas Civik as Interim Chief Executive Officer in February 2026. Mr. Civik has been a member of Pyxis Oncology’s Board of Directors since October 2021 and is a highly experienced biotechnology executive with a proven track record in advancing cancer therapeutics. He most recently served as President and Chief Executive Officer of Five Prime Therapeutics, where he led the company through its acquisition by Amgen for $1.9 billion in April 2021. Mr. Civik previously served as Chairperson of the Board of ImCheck Therapeutics and Repare Therapeutics through their respective acquisitions by Ipsen and XOMA.
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Pyxis Oncology appointed Heather Knowles as Senior Vice President, Head of Global Clinical Operations in January 2026. Ms. Knowles is a highly accomplished clinical development operations leader with more than 20 years of experience guiding global oncology programs across the full development continuum from first-in-human studies through registration. She has worked across solid tumors and hematologic malignancies and brings deep expertise spanning multiple modalities, including mRNA therapeutics, immune modulators, cell therapies, and small molecules. Ms. Knowles most recently served as Vice President, Clinical Operations, Therapeutics & Oncology at Moderna, where she built and scaled Moderna’s global clinical operations organization.
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The Company announced the appointment of Alex Kane as Senior Vice President, Investor Relations and Capital Markets in October 2025. Mr. Kane brings 20 years of experience and a proven track record in investor relations, strategic communications, and equity capital markets across the life sciences sector. Mr. Kane most recently served as Vice President of Equity CapitalMarkets at Guggenheim Securities, advising biotechnology clients on financing strategies and equity transactions. Previously, Mr. Kane held senior investor relations and communications roles at Praxis Precision Medicines and PTC Therapeutics, successfully managing IPOs, secondary offerings, and long-term investor engagement.
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Pyxis Oncology appointed Brian Freeman as Senior Vice President, Global Program Leader for MICVO in May 2025. Mr. Freeman brings deep expertise in program leadership and commercialization across a broad range of modalities, including ADCs, degraders, DACs, monoclonal antibodies, and small molecules, with a focus in Oncology and Immunology. His portfolio experience includes notable therapies such as pivekimab sunirine, Kadcyla, Xolair, Avastin, Herceptin, and Tarceva. Before joining Pyxis Oncology, Mr. Freeman led the pivekimab sunirine (IMGN-632) program at ImmunoGen/AbbVie and served as Head of Commercial Strategy at Foghorn Therapeutics.
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In December 2025, Pyxis Oncology completed sale of its rights to royalties from the commercialization of Enzeshu (Suvemcitug for Injection) for a one-time cash payment of $11 million and four semi-annual installments of $175,000 each. This non-dilutive funding will support the development of MICVO. As part of Pyxis Oncology’s acquisition of Apexigen, Inc. in August 2023, the Company acquired rights to royalties on Enzeshu and another asset discovered using APXiMAB, Apexigen’s proprietary antibody discovery platform.
Full Year 2025 Financial Results

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As of December 31, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $68.3 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the fourth quarter of 2026.
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Revenues were $13.9 million for the year ended December 31, 2025, compared to $16.1 million for the year ended December 31, 2024. Revenues for 2025 consist of the regulatory milestone related to approval of suvemcitug in China and the sale of royalty rights for Enzeshu to Simcere. Revenues for 2024 consist of the settlement and sale of royalty rights for Beovu to Novartis.
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Research and development expenses were $73.7 million for the year ended December 31, 2025, compared to $58.7 million for the year ended December 31, 2024. The increase was primarily due to a $6.1 million increase in contract manufacturing costs and a $7.5 million increase in clinical trial related expenses related to monotherapy and combination therapy of MICVO.
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General and administrative expenses were $22.2 million for the year ended December 31, 2025, compared to $25.4 million for the year ended December 31, 2024. The decrease was primarily due to lower employee-related costs including stock-based compensation, lower corporate insurance costs and a decrease in legal, professional and consulting fees.
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Net loss was $79.6 million, or ($1.28) per common share, for the year ended December 31, 2025, compared to $77.3 million, or ($1.32) per common share, for the year ended December 31, 2024. Excluding non-cash stock-based compensation expense and impairment loss, the net loss for the year ended December 31, 2025 was $67.8 million, compared to a net loss of $43.4 million for the year ended December 31, 2024.
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As of March 20, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 62,831,246.

(Press release, Pyxis Oncology, MAR 23, 2026, View Source [SID1234663828])

On March 23, 2026 PharmaMar (MSE:PHM) a Spanish biopharmaceutical company with 40 years of experience, reported that its treatment Zepzelca (lurbinectedin), in combination with atezolizumab (Tecentriq), has been approved by the Taiwan Food and Drug Administration (TFDA) as a first-line maintenance treatment for adult patients with advanced small cell lung cancer (SCLC).

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This approval as a first-line maintenance therapy means that the drug is administered after the initial induction treatment for those patients who achieve stable disease or better, in order to maintain the response achieved. In addition to Taiwan, this first-line maintenance combination has recently been approved for the same indication in the United Arab Emirates, Oman, Israel, Uruguay, Ecuador, Paraguay and Peru joining the United States and Switzerland, the first countries to have approved it for this indication. The Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA), as well as in other countries worldwide.

PharmaMar commercializes its products outside Europe through agreements with strategic partners, with the aim of facilitating patient access worldwide to its innovative oncology therapies. Specifically, the Company collaborates with Lotus Pharmaceutical in Taiwan; Immedica in Oman and the United Arab Emirates; in Israel with Megapharm and Adium Pharma in Uruguay, Paraguay, Peru and Ecuador.

Furthermore, lurbinectedin as a monotherapy is approved as a second-line treatment, that is, after disease progression during or following platinum-based chemotherapy, in 22 countries.

Small cell lung cancer accounts for about 15% of lung cancer cases and is characterized by its aggressive behavior, and an early tendency to spread.

(Press release, PharmaMar, MAR 23, 2026, View Source [SID1234663827])

On March 23, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that it has commenced a best-efforts public offering of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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

Outlook Therapeutics intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.

The securities described above are being offered by Outlook Therapeutics pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278340) that was originally filed with the Securities and Exchange Commission (the "SEC") on March 28, 2024, and became effective on April 5, 2024. This proposed public offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the effective registration statement. A preliminary prospectus supplement and an accompanying prospectus related to the proposed public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed public offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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, Outlook Therapeutics, MAR 23, 2026, View Source [SID1234663826])