On June 15, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for mKRAS-driven cancers, reported results from its randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma ("PDAC") following completion of standard locoregional therapy.

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The AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population. However, landmark analyses during active ELI-002 7P treatment indicated early treatment benefit. Post-hoc landmark analyses showed a consistent ~14% absolute DFS benefit during active treatment at both 3 and 6 months, suggesting early clinical activity, with treatment-arm separation persisting through 9 months.

While nodal status, the prespecified stratification factor, was balanced between treatment arms, a higher proportion of patients with the adverse prognostic factor, R1 resection status, were included in the ELI-002 7P arm (19% vs. 10%). Post-hoc analyses showed significant DFS improvement (R0: HR 0.65, p=0.048, n=121) in lower residual disease patients. Importantly, this subgroup represented approximately 84% of enrolled patients. Currently, there are no approved therapies following locoregional treatment.

The study informed a refined Phase 3 development strategy focused on a defined, lower residual disease, R0 resected population with additional dosing. The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes (HR 0.22, p<0.0001, n=90), supporting the biological activity of ELI-002 7P.

"While AMPLIFY-7P did not meet its primary endpoint in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward," said Robert Connelly, President and Chief Executive Officer of Elicio. "We identified the patients who benefit most, validated the biology, and demonstrated a favorable safety profile that supports extended dosing in Phase 3. In a disease where no approved options exist after surgery, we believe AMPLIFY-7P demonstrates that ELI-002 7P, an mKRAS-targeted immunotherapy, can generate robust immune responses associated with improved clinical outcomes."

Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, added, "The AMPLIFY-7P trial generated important clinical and biological insights that have sharpened our development strategy and strengthened our conviction in ELI-002 7P. The stronger treatment effect observed in completely resected R0 patients, combined with the robust relationship between KRAS-specific T-cell responses and clinical outcomes, supports a clear Phase 3 path focused on patients most likely to benefit from treatment. We look forward to discussing these findings with regulators and believe the results provide important support for the broader application of AMP-enabled immunotherapies across multiple oncogenic drivers."

Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology Memorial Sloan Kettering Cancer Center, said, "Future progress in pancreatic cancer will increasingly depend on precision medicine approaches that identify patients most likely to benefit from targeted and immune-based therapies. These findings show the promise of immunological targeting of mKRAS in patients previously considered to be refractory to immunotherapy."

The AMPLIFY-7P study enrolled 144 patients across 24 U.S. sites and evaluated ELI-002 7P versus observation in patients with resected Stage I-III mKRAS-driven PDAC who had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment.

Key Findings from AMPLIFY-7P

Post-hoc landmark analyses demonstrated a ~14% absolute improvement in DFS rates during active treatment at both 3 months (90.3% vs. 76.6%, p=0.022) and 6 months (75.7% vs. 61.7%, p=0.056).
Randomization was stratified by nodal status; however, there was an imbalance in baseline R1 resection status, a known adverse prognostic factor, which disproportionately favored the observation arm (ELI-002 7P 19% vs. observation 10%).
Multivariable analyses identified R1 resection as an adverse prognostic factor for recurrence (HR 1.56, p=0.181).
Post-hoc analyses demonstrated stronger treatment effect in the R0 resected patient population (HR 0.65, p=0.048, n=121).
mKRAS-specific T cell responses strongly correlated with improved DFS, with patients demonstrating the strongest immune responses experiencing the most favorable outcomes (T cell fold change from baseline, >9.17x vs <9.17x: HR 0.22, p<0.0001, n=90 evaluable).
ELI-002 7P demonstrated a favorable safety profile with no treatment-related discontinuations or treatment-related deaths. ELI-002 7P treatment was associated with proportionally fewer adverse events than SOC observation.
Phase 3 Development Strategy

Insights from AMPLIFY-7P have enabled Elicio to refine its Phase 3 development strategy, focusing on patients with the greatest potential to benefit from treatment and extending treatment duration to enhance the durability of anti-tumor immunity. Subject to financing, the Company plans to initiate a Phase 3 study with the following key elements:

Enrollment of R0 resected patients following completion of standard locoregional therapy
Additional dosing beyond the initial ELI-002 7P immunization and booster regimen
A registrational study with a primary endpoint of DFS
Cash Runway

As previously guided, the Company expects its current cash and cash equivalents to support planned operations into the fourth quarter of 2026. Elicio is currently evaluating multiple strategic financing and partnership opportunities to advance its planned Phase 3 adjuvant PDAC program and broader AMP platform.

Conference Call and Webcast Details
Elicio will host a conference call and webcast beginning at 8:30 AM ET today, June 15, 2026. The live webcast may be accessed HERE. The conference call can be accessed by dialing toll-free 1-877-407-9208 or 1-201-493-6784 (international). The conference call ID is 13761190.

A replay of the webcast will be available on the "EVENTS" tab in the Investors section of the Company’s website.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Based on topline results and post-hoc analyses, Elicio has refined its Phase 3 development strategy to focus on patients with lower residual disease burden and extended treatment duration. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

About the AMP Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapy directly to the "brain center" of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In pre-clinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.

Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapy directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.

(Press release, Elicio Therapeutics, JUN 15, 2026, View Source [SID1234668748])

On June 15, 2026 enGene Therapeutics Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company reported its financial results for the second quarter ended April 30, 2026, and provided clinical and corporate updates.

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"Feedback from the urology community on the emerging detalimogene without surfactant profile, presented at the AUA meeting in May, supports our plan to await mature durability data in the second half of 2026 and meet with the FDA about initiating a BLA submission for detalimogene before year end," said Ron Cooper, President and Chief Executive Officer, enGene.

Mr. Cooper continued, "We are also encouraged by the interest in the detalimogene surfactant bladder rinse study from the medical community. With patients already enrolled, we are optimistic about the potential to further enhance efficacy while maintaining the ease of use and tolerability profile that has resonated with urologists."

"To preserve shareholder capital as we await additional durability data and meetings with the FDA, we made the very difficult decision to downsize the organization to streamline operations. We are sincerely grateful to the enGeneers who have created a high-performance culture and helped advance detalimogene and our mission to provide people living with NMIBC a new treatment option," added Mr. Cooper.

Recent Clinical Updates

LEGEND Pivotal Cohort 1: During a plenary presentation at the recent American Urological Association (AUA) meeting, interim data were shared from LEGEND’s pivotal Cohort 1 studying detalimogene without surfactant in high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS).

Efficacy overview:

54% (95% CI: 45%, 63%) complete response (CR) at any time (67/124)
Low rate of progression to muscle invasive or more advanced disease (3.2%)
Safety overview:

Low percentage of patients experienced treatment-related adverse events (TRAEs) leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)
Twenty-one patients were pending disease assessments at either six-, nine-, or 12-months as of the data cutoff date of April 21, 2026. enGene is awaiting 12-month CR data from Cohort 1, as well as the majority of 12-month durability data, and expects to engage with the FDA in 2H 2026 to discuss a BLA filing.

Detalimogene plus Surfactant Cohort: In tandem with its pivotal update in May, the Company announced the initiation of an additional LEGEND cohort, which incorporates a short surfactant bladder rinse using diluted polidocanol solution. Polidocanol is an FDA-approved product used for the treatment of spider and reticular veins. Surfactants have been shown to boost efficacy with other gene therapies in preclinical models and were subsequently incorporated into clinical development of those gene therapies. In murine models tested by the Company, pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression and was able to boost efficacy of a subtherapeutic dose of detalimogene. Findings were validated in a large mammal model tested by the Company where a surfactant rinse increased the distribution of detalimogene nanoparticles throughout the bladder by approximately 50% and IL-12 expression by nine-fold. The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort. The Company believes this approach has the potential to further enhance efficacy and durability while preserving the simplicity, tolerability, and office-based administration profile that may make detalimogene a preferred option for community urology practices, where approximately 80% of NMIBC patients receive treatment.

LEGEND Cohorts 2a, 2b and 3: As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026.

Recent Corporate Updates

Reduction in Force and Executive Departures: In June 2026, enGene implemented a plan to reduce its workforce by approximately 50% to streamline operations and preserve cash. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including completion of LEGEND Cohort 1; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for BLA initiation in 2H 2026; and completing necessary pre-commercial activities required to support the planned commercial launch of detalimogene in 2027.

In conjunction with its reduction in force, the following executive officers will depart from the Company, effective July 15, 2026: Ryan Daws, Chief Financial Officer, Lee Giguere, Chief Legal Officer and Alex Nichols, Chief Strategy and Operations Officer.

Anthony Cheung, Chief Scientific Officer, will continue in his role through September 30, 2026, after which, he will transition into a consulting arrangement.

Hussein Sweiti, M.D., Chief Medical Officer, stepped down from his position to pursue a new professional opportunity, effective June 14, 2026. Effective immediately, William Grossman, M.D., Ph.D., a member of enGene’s Board of Directors, will act as interim Chief Medical Officer. He is the former Senior Vice President and Therapeutic Area Head of Oncology Clinical Development at Gilead Sciences Inc. where he oversaw the oncology portfolio (early and late-stage clinical development) and collaboration programs. Prior to that, he held several Chief Medical Officer roles including at Arcus Biosciences and Bellicum Pharmaceuticals. He has held additional leadership roles at Genentech/Roche, Merck, AbbVie, and Biothera. Dr. Grossman received his M.D. and Ph.D. in Immunology from Washington University School of Medicine’s Medical Scientist Training Program and completed his medical and post-doctoral training in both the Divisions of Pediatrics and Medicine at Washington University School of Medicine. He also currently serves on several advisory boards and will continue to serve on enGene’s Board of Directors as a non-independent Director during his interim CMO role.

Constantine Chinoporos, who joined the Company in May as a business development consultant, is expected to act as enGene’s interim Chief Business Officer. Mr. Chinoporos brings deep experience across business development, licensing, and M&A in the biopharma sector. He is a member of the Board of Directors at Geron Corporation, and most recently served as Chief Operating Officer and Chief Business Officer of Applied Therapeutics. Prior to his role at Applied Therapeutics, Mr. Chinoporos served as Chief Business Officer at Albireo Pharmaceuticals, Inc. from 2021 until its acquisition by Ipsen S.A. in 2023. From 2015 to 2021, he served as Chief Business Officer at Boston Pharmaceuticals, Inc. Previously, he held senior positions in worldwide licensing, business development, corporate development, corporate finance and alliance management at Sanofi S.A., Genzyme Corporation, and Eli Lilly and Company. Mr. Chinoporos holds an M.B.A. from the Johnson Graduate School of Management at Cornell University and a B.A. in History from Cornell University.

Anticipated Milestones

12-month complete response data for all of Cohort 1 and pre-BLA meeting in 2H 2026
Initiation of BLA filing for detalimogene in 2H 2026
Potential detalimogene FDA approval decision and platform designation in 2027
Second Quarter 2026 Financial Results

As of April 30, 2026, cash, cash equivalents and marketable securities were $285.2 million providing significant operational flexibility.

Total operating expenses were $32.0 million for the three months ended April 30, 2026, compared to $27.1 million for the three months ended April 30, 2025. Research and development expenses increased by $2.0 million, primarily driven by increased personnel and clinical costs related to our LEGEND trial, completion of PPQ batch manufacturing and preparation to initiate the submission of a planned Biologics License Application with the FDA in the second half of 2026. General and administrative expenses increased by $2.9 million, primarily driven by annualization of personnel-related costs and increased facility costs.

For the three months ended April 30, 2026, net loss attributable to common shareholders was approximately $30.2 million, or $0.43 per share, compared to approximately $25.8 million, or $0.51 per share, for the three months ended April 30, 2025. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes four additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3); and BCG-unresponsive high-risk NMIBC patients with CIS who receive polidocanol plus detalimogene.

(Press release, enGene Therapeutics, JUN 15, 2026, View Source [SID1234668747])

On June 15, 2026 Sumitomo Pharma America, Inc. (SMPA) reported the presentation of new clinical and translational research at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, held from June 11-14, 2026, in Stockholm, Sweden.

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Among the data is the first-ever disclosure of preliminary clinical data for the investigational PIM1 inhibitor nuvisertib in combination with momelotinib (MMB) for patients with myelofibrosis (MF), and new translational research into the mechanistic basis for hemoglobin improvement observed in patients with MF in an ongoing Phase 1/2 study with nuvisertib. Alongside these findings, SMPA is also sharing new data gathered around acquired resistance patterns observed with enzomenib in acute leukemia.

"We are excited to present the preliminary data for our investigational combination of nuvisertib and momelotinib at EHA (Free EHA Whitepaper) 2026, while also sharing learnings from our ongoing translational research of nuvisertib and enzomenib," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "We appreciate this opportunity to share the latest data for these two programs with the oncology community, and these results reinforce our commitment to developing multi-faceted therapeutic approaches that address the most persistent challenges in treating hematologic malignancies."

Promising clinical response with nuvisertib and momelotinib in myelofibrosis
James McCloskey, M.D., Interim Chief of the Division of Leukemia, John Theurer Cancer Center, Hackensack, USA, presented preliminary clinical data from the ongoing global Phase 1/2 study (NCT04176198). As of December 6, 2025, a total of 26 patients with relapsed/refractory (R/R) MF and anemia were enrolled across four dose levels of nuvisertib (240, 360, 480, and 720 mg twice daily under fed condition) in combination with the approved dose of momelotinib in MF (200 mg once daily). This study population was particularly challenging to treat as every patient had previously received at least one approved Janus Kinase (JAK) inhibitor and 41% of patients carried high molecular risk (HMR) mutations. Despite these complexities, the combination appeared well tolerated with no dose-limiting toxicities (DLTs) observed. The most common treatment-related adverse events occurring in ≥20% patients were diarrhea, nausea, and thrombocytopenia. The most frequent treatment-related Grade 3 adverse event was thrombocytopenia without bleeding, which occurred in three patients. Of note, mean hemoglobin and platelet count levels remained stable throughout the 24-week treatment period.

Among the efficacy evaluable patients who completed at least 12 weeks of treatment (n=15), the combination of nuvisertib and momelotinib demonstrated evidence of clinical activity. Spleen volume reduction of at least 25% (SVR25) was achieved by 73% of patients at Week 12 and reached 100% at Week 24 (n=5). Similarly, 53% of patients achieved a total symptom score reduction of at least 50% percent (TSS50) at Week 12 that further improved to 60% of patients at Week 24 (n=5). Anemia response by IWG ELN2024 criteria was observed in 50% of patients at any time. Most significantly, 60% of patients achieved a triple response at the Week 24 mark, meeting concurrent criteria for symptom reduction, spleen volume reduction, and anemia improvement.

The development of nuvisertib and momelotinib combination therapy was driven by the need to address the pathways that drive MF progression more comprehensively. While standard treatments focus on inhibiting the JAK signaling pathway, research has shown that PIM1 expression is often upregulated in MF and can be driven by JAK-independent compensatory pathways, such as Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-kB) and Ets Related Gene (ERG). These secondary pathways can allow the disease to survive and progress even during JAK inhibitor therapy. By combining nuvisertib with the JAK/Activin A Receptor Type 1 (ACVR1) inhibitor momelotinib, researchers aim to shut down these escape routes, potentially leading to deeper and more durable clinical responses for patients.

New Nuvisertib translational research presented in MF
Joseph M Scandura, M.D., Ph.D., Division of Hematology and Medical Oncology, Weill/Cornell Leukemia Program, New York, USA, presented translational research further elucidating the proposed mechanism of action of nuvisertib. In addition to its primary activity as a PIM1 inhibitor, in vitro and biochemical data demonstrated that nuvisertib also binds to and inhibits ACVR1, resulting in reduced hepcidin mRNA expression, a central regulator of iron homeostasis. Consistent with these findings, preliminary clinical data from a Phase 1/2 study of nuvisertib monotherapy showed reduced hepcidin levels in patients with R/R MF, providing a potential mechanistic explanation for the hemoglobin stability and improvement observed in patients with MF treated with nuvisertib.

"Preliminary clinical data suggests that the combination of nuvisertib and momelotinib may provide a more comprehensive suppression of the disease pathways driving myelofibrosis," said Raajit Rampal, M.D. Ph.D., Director of the Myeloproliferative Neoplasms Program at the Memorial Sloan Kettering Cancer Centre, New York, USA. "The promising symptom, spleen and anemia responses, coupled with the new nonclinical data on potential dual PIM1 and ACVR1 inhibitory activity by nuvisertib, suggest that this combination therapy may potentially offer meaningful clinical benefits for patients with myelofibrosis."

Translational research in leukemia and menin inhibition identifies E368K mutation as key resistance signature at relapse
Also, during the conference, translational research in leukemia and menin inhibition was shared by Jevon Cutler, PhD, Assistant Professor of Cell, Developmental and Cancer Biology at the Oregon Health Sciences University School of Medicine, that identified distinct MEN1 mutational signatures associated with acquired resistance to the menin inhibitor (MI) enzomenib in patients with acute leukemia. Serial molecular profiling revealed that the E368K mutation was the predominant resistance signature identified at relapse, appearing in 53% of patients who relapsed after an initial response. Preclinical work predicted the E368K mutation to be the primary resistance mutation and that this mutation may not affect the other menin inhibitors; these findings support the further exploration of rational, sequential MI therapy to improve clinical outcomes for patients with acute leukemia.

Presentation Details

Abstract title

Lead Author

Investigational PIM1 Inhibitor Nuvisertib in Combination with Momelotinib Showed Promising Clinical Activity in Patients with Myelofibrosis and Anemia: Data from an Ongoing Global Phase 1/2 Study

James McCloskey, MD

Preclinical Evidence of Targeting ACVR1/Hepcidin by Nuvisertib, an Oral Investigational PIM1 Kinase Inhibitor, Suggests Potential Mechanistic Basis for Hemoglobin Benefit in Myelofibrosis

Joseph M Scandura, MD, PhD

Distinct MEN1 Mutational Signatures Are Associated with Acquired Resistance During MENIN-KMT2A Inhibition in a Phase 1 Enzomenib Trial

Jevon Cutler, PhD

(Press release, Sumitomo Dainippon Pharma, JUN 15, 2026, View Source [SID1234668746])

On June 15, 2026 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported that it has commenced a private offering of $275 million aggregate principal amount of convertible senior notes due 2032 (the "notes") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). In connection with this offering, NeoGenomics expects to grant the initial purchasers of the notes an option to purchase, for settlement within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $41.25 million aggregate principal amount of the notes. The offering of the notes 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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The notes will be senior, unsecured obligations of NeoGenomics, will accrue interest payable semi-annually in arrears and will mature on July 1, 2032, unless earlier converted, redeemed or repurchased. Noteholders will have the right to convert their notes in certain circumstances and during specified periods. NeoGenomics will settle conversions by paying or delivering, as applicable, cash, shares of its common stock, par value $0.001 per share ("common stock"), or a combination of cash and shares of its common stock, at NeoGenomics’ election. The notes will be redeemable, in whole or in part (subject to certain limitations), for cash at NeoGenomics’ option at any time, and from time to time, on or after July 6, 2029 and on or before the 51st scheduled trading day immediately preceding the maturity date, if the last reported sale price per share of NeoGenomics’ common stock equals or exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. In addition, the notes will be redeemable at any time if the aggregate principal amount of the notes that remains outstanding is less than 15% of the aggregate principal amount of the notes initially issued in the offering and certain other conditions are satisfied. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

In connection with the pricing of the notes, NeoGenomics expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers or their respective affiliates or other financial institutions (the "option counterparties"). The capped call transactions are expected generally to reduce potential dilution to NeoGenomics’ common stock upon conversion of any notes and/or offset any potential cash payments NeoGenomics is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction and/or offset subject to a cap.

NeoGenomics has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to purchase shares of NeoGenomics’ common stock and/or enter into various derivative transactions with respect to NeoGenomics’ common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of NeoGenomics’ common stock or the notes at that time. In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to NeoGenomics’ common stock and/or purchasing or selling NeoGenomics’ common stock or other securities of NeoGenomics in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or following certain repurchases or redemptions of the notes). This activity could cause or avoid an increase or a decrease in the market price of NeoGenomics’ common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs following conversion or during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that holders will receive upon conversion of such notes.

NeoGenomics intends to use a portion of the net proceeds from the offering to pay the cost of the capped call transactions. If the initial purchasers exercise their option to purchase additional notes, NeoGenomics expects to use a portion of the net proceeds from the sale of the additional notes to enter into additional capped call transactions. In addition, NeoGenomics intends to use a portion of the remaining net proceeds from the offering, together with cash on hand, to repurchase a portion of NeoGenomics’ 0.25% convertible senior notes due 2028 (the "existing notes") through privately negotiated transactions entered into concurrently with the pricing of the notes effected through one or more of the initial purchasers or their affiliates as our agents, and a portion of the remaining net proceeds from the offering, if any, together with cash on hand, to repurchase up to $25 million of shares of our outstanding common stock from certain purchasers of the notes in privately negotiated transactions, effected through one or more of the initial purchasers or their respective affiliates as our agent, entered into concurrently with the pricing of this offering, and the remainder of the net proceeds, if any, for general corporate purposes.

The concurrent repurchases of the existing notes and shares of Company’s common stock described above may result in the Company’s common stock trading at prices that are higher than would be the case in the absence of these repurchases, which may result in a higher initial conversion price for the notes to be offered.

NeoGenomics expects to repurchase for cash a portion of the existing notes through privately negotiated transactions (the "note repurchase transactions") entered into concurrently with the pricing of the notes. The terms of each note repurchase transaction will depend on a variety of factors, including the market price of NeoGenomics’ common stock and the trading price of the existing notes at the time of the note repurchase transactions. No assurance can be given as to how much, if any, of the existing notes will be repurchased or the terms on which they will be repurchased. This press release is not an offer to repurchase the existing notes, and the offering of the notes is not contingent upon the repurchase of the existing notes.

In connection with the note repurchase transactions, NeoGenomics expects that holders of the existing notes who agree to have their existing notes repurchased and who have hedged their equity price risk with respect to such existing notes (the "hedged holders") will unwind all or part of their hedge positions by buying NeoGenomics’ common stock and/or entering into or unwinding various derivative transactions with respect to NeoGenomics’ common stock. The amount of NeoGenomics’ common stock to be purchased by the hedged holders or the notional number of shares of NeoGenomics’ common stock underlying such derivative transactions may be substantial in relation to the historic average daily trading volume of NeoGenomics’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of NeoGenomics’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. NeoGenomics cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or NeoGenomics’ common stock and the corresponding effect on the initial conversion price of the notes.

The notes will be offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold absent registration or except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

(Press release, NeoGenomics Laboratories, JUN 15, 2026, View Source [SID1234668745])

On June 15, 2026 Rznomics Inc., a biopharmaceutical company specializing in the development of RNA-based gene therapies, reported that the Phase 1/2a interim clinical results for ‘RZ-001 (Taspitimagene advec)’, its RNA editing-based anticancer gene therapy for recurrent glioblastoma (rGBM), were presented on June 13th at the Asian Society for Neuro-Oncology Annual Meeting (ASNO 2026) held in Kanazawa, Japan.

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The presentation was delivered by Dr. Chae-Yong Kim, a professor of the Department of Neurosurgery at Seoul National University Bundang Hospital, highlighting the safety and preliminary efficacy data from the ongoing clinical trial.

RZ-001 is an innovative anticancer gene therapy utilizing Rznomics’ proprietary RNA trans-splicing ribozyme platform, engineered to express a therapeutic gene specifically inside tumor cells to induce cancer cell death. According to the presentation, 20 patients have completed screening to date, with 10 patients officially enrolled and treated in the trial.

The interim analysis revealed that no new or unexpected treatment-related safety concerns have been identified. No dose-limiting toxicity (DLT) was reported, and no treatment-related Grade 4 or higher adverse events were observed. Most reported adverse events were deemed to be disease-related or associated with underlying conditions typical of glioblastoma patients. Furthermore, several patients demonstrated prolonged tumor recurrence inhibition and disease control exceeding six months.

Recurrent glioblastoma is one of the most aggressive and intractable malignant brain tumors, notorious for high recurrence rates and an extremely poor prognosis even after standard-of-care treatments. With currently approved treatment options showing limited efficacy and conventional immuno-oncology therapies repeatedly facing clinical failures, rGBM represents an area with immense unmet medical needs for novel therapeutic mechanisms.

"The secured data demonstrate a manageable safety profile for RZ-001 alongside encouraging preliminary signs of clinical activity," explained Dr. Chae-Yong Kim. "Given that recurrent glioblastoma typically recurs within two to four months, the data from patients showing long-term recurrence inhibition—particularly that of extending past nine months—is highly encouraging. We look forward to further clarifying its full clinical value through additional patient enrollment and long-term follow-up observations."

Meanwhile, RZ-001 is currently undergoing clinical development for both recurrent glioblastoma and hepatocellular carcinoma (HCC). The HCC program recently achieved a significant milestone by receiving Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA this past May.

(Press release, Rznomics, JUN 15, 2026, View Source [SID1234668744])