On May 28, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported sale of an aggregate of 7,222,223 shares of its common stock (or pre-funded warrants in lieu therof) and short-term warrants to purchase up to an aggregate of 14,444,446 shares of common stock at a purchase price of $0.45 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrants in a private placement priced at-the-market under Nasdaq rules (Press release, IMUNON, MAY 28, 2025, View Source [SID1234653441]). The warrants are exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants at an exercise price of $0.45 per share and will expire three years from the date of stockholder approval.

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H.C. Wainwright & Co. acted as the exclusive lead placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agent.

The aggregate gross proceeds to the Company from the private placement was approximately $3.25 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $6.5 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The shares of common stock, pre-funded warrants and short-term warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and short-term warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the short-term warrants and the shares of common stock underlying the pre-funded warrants and short-term warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the shares of common stock and the shares issuable upon exercise of the pre-funded warrants and short-term warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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.

On May 28, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported presentations on RYTELO (imetelstat) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (Press release, Geron, MAY 28, 2025, View Source [SID1234653440]). Together, the presentations reinforce the potential benefits of the first-in-class oligonucleotide telomerase inhibitor RYTELO for a range of patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia and showcase the progress Geron is making with the ongoing IMpactMF and IMproveMF trials of imetelstat in myelofibrosis (MF).

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"Transfusion independence is an important goal for LR-MDS patients, but one that historically has not been achievable for many," said Rami S. Komrokji, M.D., Vice Chair, Malignant Hematology Department, Moffitt Cancer Center. "While imetelstat is already playing a vital role in LR-MDS, these new analyses being presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) reinforce its potential to give a broad range of patients more time without transfusions and should also give clinicians confidence to add it to their toolkit as a second-line option for eligible patients."

Presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include:

New pooled, post-hoc analyses expand on the pivotal IMerge results across challenging LR-MDS subpopulations

Analysis of patients with ring sideroblast negative (RS-) disease, showing that these difficult-to-treat patients appeared to experience clinical benefit with RYTELO, including ≥8-week, ≥24-week and ≥1-year red blood cell transfusion independence (RBC-TI), duration of RBC-TI, and hemoglobin rise in patients who achieved RBC-TI, consistent with prior findings from the overall Phase 3 IMerge population.
Analysis showing clinical benefit with RYTELO regardless of baseline serum erythropoietin (sEPO) level, supporting the use of RYTELO in the frontline setting for LR-MDS patients ineligible for erythropoiesis-stimulating agents (ESAs), and in the second-line setting after ESAs regardless of sEPO.
Analysis showing clinical benefit with RYTELO in ESA-ineligible or relapsed/refractory patients regardless of prior treatment with luspatercept or lenalidomide. Patients who had prior treatment with a hypomethylating agent (HMA) showed modest clinical activity with RYTELO.
Patient-centric outcome measures offering deeper insight on RYTELO impact in new post-hoc analyses from Phase 3 IMerge trial

Analysis showing that certain RYTELO-treated patients experienced sustained improvements in health-related quality-of-life (QOL) compared with placebo, as measured by certain categories in the patient-reported QOL in Myelodysplasia Scale (QUALMS) instrument.
Exploratory analysis suggesting that certain patients treated with RYTELO experienced a longer mean duration of time without transfusion reliance or relapse (TWiTR), compared with placebo.
New updates on ongoing trials in MF

Recently updated preliminary data from the dose escalation portion of the Phase 1/1b IMproveMF trial showing the combination of imetelstat and ruxolitinib was generally well-tolerated, with no dose-limiting toxicities observed as of the data cutoff date, and encouraging early dose-dependent efficacy data suggesting the potential of the combination for patients with intermediate-1 (INT-1), intermediate-2 (INT-2) or high-risk (HR) MF.
Trial-in-progress (TiP) update on the Phase 3 IMpactMF trial investigating imetelstat in relapsed/refractory MF, reporting that the trial has met approximately 80% of its enrollment target as of February 2025.
"At ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), we’re excited to present new analyses on how RYTELO can deliver meaningful benefit across a range of LR-MDS patients who otherwise may have had limited options, whether due to their ring sideroblast status, baseline EPO level, or their treatment history," said Faye Feller, M.D., Executive Vice President and Chief Medical Officer of Geron. "We believe the depth and breadth of our data reinforce the potential of RYTELO to address critical unmet needs in LR-MDS and, combined with the advances we are making with our myelofibrosis program, underscore our confidence in telomerase inhibition as a potentially transformative clinical strategy and our commitment to exploring its full potential."

See below for a full schedule of presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

ASCO 2025 Presentations

Presentation Title

Author

Abstract Number

Presentation Details

IMproveMF update: phase 1/1B trial of imetelstat (IME)+ruxolitinib (RUX) in patients (pts) with intermediate (INT)-1, INT-2, or high-risk (HR) myelofibrosis (MF)

John O. Mascarenhas, M.D.

#6515

Rapid Oral, Fri. May 30, 1:00-2:30 PM CDT

Effect of prior treatment (tx) on the clinical activity of imetelstat (IME) in transfusion-

dependent (TD) patients (pts) with erythropoiesis-stimulating agent (ESA), relapsed or

refractory (R/R)/ineligible lower-risk myelodysplastic syndromes (LR-MDS)

Rami S. Komrokji, M.D.

#6569

Poster, Sun. June 1, 9:00 AM-12:00 PM CDT

IMpactMF, randomized, open-label, phase 3 trial of imetelstat (IME) versus best available therapy (BAT) in patients (pts) with intermediate-2 (INT-2) or high-risk (HR) myelofibrosis (MF) relapsed or refractory (R/R) to Janus kinase inhibitors (JAKi)

John O. Mascarenhas, M.D.

#TPS6588

Poster, Sun. June 1, 9:00 AM-12:00 PM CDT

EHA 2025 Presentations

Presentation Title

Author

Abstract Number

Presentation Details

Increased Duration of Time Without Transfusion Reliance (TWiTR) For Patients with LR-MDS Treated with Imetelstat Versus Placebo in the IMerge Trial

Mikkael A. Sekeres, M.D.

#PF646

Poster, Fri. June 13, 18:30-19:30 CEST

IMproveMF Update: Phase 1/1B Trial of Imetelstat + Ruxolitinib in Patients with INT-1, INT-2, or High-Risk MF

John O. Mascarenhas, M.D.

#PF830

Poster, Fri. June 13, 18:30-19:30 CEST

IMpactMF: Randomized, Open-Label, Phase 3 Trial of Imetelstat vs Best Available Therapy in Patients with INT-2 or High-Risk MF Relapsed/Refractory to JAK Inhibitors

John O. Mascarenhas, M.D.

#PF841

Poster, Fri. June 13, 18:30-19:30 CEST

Health-related Quality of Life Outcomes in Patients with Lower-Risk Myelodysplastic Syndromes Treated with Imetelstat in the IMerge Trial

María Díez-Campelo, M.D., Ph.D.

#PS1639

Poster, Sat. June 14, 18:30-19:30 CEST

Outcomes of Imetelstat Therapy in RS-Negative LR-MDS from the Pooled IMerge Study Populations

Valeria Santini, M.D.

#PS1622

Poster, Sat. June 14, 18:30-19:30 CEST

Outcomes with Imetelstat by Serum Erythropoietin Levels in Patients with LR-MDS Who Were Treatment Naïve or Who Had Prior Treatment with Erythropoiesis-Stimulating Agents

Rami S. Komrokji, M.D.

#PS1640

Poster, Sat. June 14, 18:30-19:30 CEST

Characterization and Management of Transient Cytopenias Associated with Imetelstat in LR-MDS from the IMerge Trial

Amer M. Zeidan, M.D.

#PB2760

Publication-only

Please see the full presentations for important qualifications and limitations on these post-hoc analyses.

About RYTELO (imetelstat)

RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

On May 28, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators presented positive preclinical data and research from studies of GPX-002, the Company’s diabetes gene therapy drug candidate, in an oral presentation at the American Society of Gene and Cell Therapy’s (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting which took place May 13-17, 2025 in New Orleans, Louisiana (Press release, Genprex, MAY 28, 2025, View Source [SID1234653439]).

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"We are pleased with the preclinical studies evaluating our novel gene therapy in diabetes, and we are proud to have been selected to present this data before an audience of innovators in cell and gene therapy," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe GPX-002 offers a promising opportunity for curative therapy in diabetes, which could impact the millions of patients suffering from this debilitating disease."

The oral presentation details for the Genprex-supported abstract:

Abstract Title: Immune Modulation Sustains Alpha Cell Reprogramming and Mitigates Immune Responses to AAV in a Diabetic Non-Human Primate Model

Session Title: Challenges in Immunological Responses to Therapeutic Interventions

Presenter: Hannah Rinehardt, MD, University of Pittsburgh Medical Center

Presentation Date: May 16, 2025

Presentation Time: 4:15 – 4:30 p.m. CT

Location: Room 278-282

In the oral presentation, Dr. Rinehardt discussed GPX-002, the diabetes gene therapy, which uses intraductal infusion of recombinant adeno-associated virus (rAAV) to deliver the Pdx1 and MafA genes. The gene therapy converts alpha cells into beta-like cells that secrete insulin physiologically, reversing diabetes in mouse models, where immunosuppression was not necessary. Researchers evaluated the immune response to direct infusion of rAAV into the pancreatic duct of Non-Human Primates (NHPs) with streptozotocin-induced diabetes and evaluated how to best manage immune responses.

Diabetes was induced with streptozotocin (STZ) in cynomolgus macaques, a type of NHP. NHPs received retrograde intraductal infusion of rAAV via laparotomy for precise delivery to the pancreas. rAAV capsids were chosen based on tropism for endocrine cells, and pre-existing neutralizing antibody titers (NAbs) were negative. Blood work, including serum C peptide and IV glucose tolerance tests, were serially obtained to monitor therapeutic efficacy. Immune response monitoring was performed for up to 4 months post-infusion and included serial NAbs, ELISpot assays, and immunophenotyping. Pancreatic tissues were analyzed using IHC and RNA-scope for beta cell markers, as well as single-cell RNA transcriptomics.

Expression of viral proteins occurs for a limited period of time after rAAV infection, since the infection doesn’t produce new AAV virus. One-month post-infusion, NHPs showed improved glucose tolerance and reduced insulin requirements. In the following months, using steroid-sparing regimens, increases in pancreatic B and T lymphocyte populations were noted on scRNA sequencing. Temporary immunosuppression (IS), using a combination of rituximab, rapamycin, and steroids for a 3-month course is largely effective at preventing anti-viral immunity. However, discontinuation of IS at 3 months post-infusion led to an immune response afterwards, indicating that IS in NHPs may need to be continued longer.

In conclusion, the novel rAAV gene therapy demonstrated that infusion of rAAV directly into the pancreatic duct of NHPs improves glucose tolerance but induces an anti-viral immune response which can degrade the improvement in glucose tolerance. The anti-viral immune response in NHPs can be largely prevented by administration of a multi-agent IS that leads to sustained therapeutic effects.

Researchers are continuing preclinical studies of GPX-002 therapy in NHP models of both Type 1 and Type 2 diabetes to generate additional data, and present studies are evaluating viral efficacy after six months of immunosuppression.

For more in-depth preclinical data supporting GPX-002, please review Genprex’s Corporate Presentation.

About GPX-002

GPX-002, which has been exclusively licensed from the University of Pittsburgh, is currently being developed using the same construct for the treatment of both Type 1 diabetes (T1D) and Type 2 diabetes (T2D). The same general novel approach is used in each of T1D and T2D whereby an adeno-associated virus (AAV) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In vivo, preclinical studies show that GPX-002 restored normal blood glucose levels for an extended period of time in T1D mouse models. In T2D, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

On May 28, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Exact Sciences, MAY 28, 2025, View Source [SID1234653438]). Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect, in predicting recurrence in stage II–IV colorectal cancer. These data confirm the test’s role in supporting treatment and surveillance decisions.

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Building on this momentum and its commitment to innovation, Exact Sciences will introduce a next-generation version of the test leveraging the Broad Institute’s MAESTRO technology. Early data show the test will track up 5,0002 patient specific variants and detect ctDNA* levels below 1 part per million.1 The test will be available to both new and existing customers in 2026.

"We launched the Oncodetect test to give clinicians and patients a powerful tool for detecting cancer recurrence earlier and with greater precision—progress that’s already being realized," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "We continue to innovate and look forward to introducing the next iteration of the Oncodetect test, which leverages whole-genome sequencing and proprietary technology developed in collaboration with the Broad Institute to enhance sensitivity and expand clinical utility."

The Beta-CORRECT study demonstrates that the Oncodetect test significantly improves prognosis prediction compared to traditional standard of care methods †,3,4,5

Data presented at ASCO (Free ASCO Whitepaper) from the Beta-CORRECT clinical validation study confirm that the Oncodetect test accurately predicts recurrence in stage III colorectal cancer3—consistent with findings from the Alpha-CORRECT study—and extends this association to stages II and IV.4

Exact Sciences’ largest MRD clinical study to date, with more than 400 patients, demonstrates those with ctDNA-positive results after therapy and during surveillance showed a 24- and 37-fold increased risk of recurrence, respectively.4 By quantifying ctDNA levels across multiple timepoints, the Oncodetect test enables physicians to more effectively guide treatment decisions and surveillance strategies in clinical practice.3,4

Advancing the Oncodetect test with next generation innovation

The next-generation MRD test, currently in validation across multiple solid tumor types, will track up to 5,000 patient-specific variants2 with a limit of detection below 1 part per million,1 enabling scalable monitoring and broad clinical utility. Exact Sciences holds exclusive rights to the Broad Institute’s MAESTRO technology, a whole-genome sequencing method able to detect low-frequency ctDNA mutations with high accuracy. This technology advances the ability to look broadly across thousands of mutations while reducing the sequencing depth required to achieve an ultra-low limit of detection at a highly attractive cost point. Through continued innovation in MRD, Exact Sciences is advancing solutions with the potential to change clinical practice.

"The precision and sensitivity seen in the next generation test reflect deep scientific collaboration and a shared commitment to advancing MRD technology," said Viktor Adalsteinsson, Ph.D., Director, Gerstner Center for Cancer Diagnostics at the Broad Institute. "This approach to innovation will continue to raise the bar for recurrence monitoring, treatment response assessment, and, ultimately, patient outcomes."

On May 28, 2025 EORTC, reported to be participating in the ASCO (Free ASCO Whitepaper) 2025 Annual Meeting, taking place from 30 May to 3 June in Chicago (Press release, EORTC, MAY 28, 2025, View Source [SID1234653437]). During the event, it will present eight significant abstracts, comprising three oral presentations and five posters. These will highlight our latest findings in brain tumours, melanomas, breast cancer, head and neck cancers, lung cancer, and genitourinary cancers.

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Please refer to the table below for further details.

EORTC Abstracts Practical information
Final clinical and molecular analysis of the EORTC randomized phase III intergroup CATNON trial on concurrent and adjuvant temozolomide in anaplastic glioma without 1p/19q codeletion: NCT00626990.
Martin Van Den Bent Date: Friday, 30 May 2025
Time: 15:09-15:21 CDT
Type: Oral Abstract Session
Room: S100bc | Live stream
Abstract: 2002
Primary analysis of the EORTC-2139-MG/Columbus-AD trial: A randomized trial of adjuvant encorafenib and binimetinib versus placebo in high-risk stage II melanoma with a BRAF-V600E/K mutation.
Alexander van Akkooi Date: Tuesday, 3 June 2025
Time: 09:57-10:09 CDT
Type: Oral Abstract Session
Room: S100a | Live Stream
Abstract: LBA9501
EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA).
Michail Ignatiadis Date: Monday, 2 June 2025
Type: Poster Session
Room: Hall A – Posters and Exhibits
Abstract: TPS620
Personalized biomarker-based treatment strategy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Results of the biomarker-driven cohorts of the EORTC-HNCG-1559 trial (UPSTREAM).
Jean-Pascal H. Machiels Date: Monday, 2 June 2025
Type: Poster Session
Room: Hall A – Posters and Exhibits
Abstract: 6028
Efficacy and safety of nivolumab plus ipilimumab for patients with pre-treated type B3 thymoma and thymic carcinoma: Results from the EORTC-ETOP NIVOTHYM phase II trial.
Nicolas Girard Date: Sunday, 1 June 2025
Time: 17:36-17:42 CDT
Type: Rapid Oral Abstract Session
Room: Hall D1 | Live Stream
Abstract: 8016
PSA and alkaline phosphatase changes in the EORTC-1333 PEACE-3 study evaluating the addition of six cycles of radium 223 in metastatic castration-resistant prostate cancer (mCRPC) starting enzalutamide.
Andrey Soares Date: Monday, 2 June 2025
Type: Poster Session
Room: Hall A – Posters and Exhibits
Abstract: 5062
Mechanisms of resistance to anti-PD1 treatment in recurrent and/or metastatic squamous cell carcinoma of the head and neck: A multi-omics IMMUCAN/EORTC analysis.
Athénaïs van der Elst Date: Monday, 2 June 2025
Type: Poster Session
Room: Hall A – Posters and Exhibits
Abstract: 6050
The tumoral molecular landscape of long-term survivors with isocitrate dehydrogenase wildtype glioblastoma: Lessons from ETERNITY (EORTC 1419).
Michael Weller Date: Saturday, 31 May 2025
Type: Poster Session
Room: Hall A – Posters and Exhibits
Abstract: 2059