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Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

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The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHA (Free EHA Whitepaper)web.org website.

EHA 2026 Presentation Details

Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial
Session: s446 Novel treatments in AML
Date and Time: Sunday, June 14; 11:00-12:15 CEST
Location: Nobel Hall
Publication Number: S130

Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia
Session: Poster Session 1
Date and Time: Friday, June 12; 18:45-19:45 CEST
Location: Poster Hall
Publication Number: PF537

Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial
Location: Online Publication
Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST
Publication Number: PB2766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and a clinical investigator from the KOMET-007 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665543])

Karyopharm to Participate at Upcoming Investor Conferences

On May 12, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in the following investor conferences in May:

H.C. Wainwright 4th Annual BioConnect Investor Conference
Format: Fireside chat
Date: Tuesday, May 19, 2026
Time: 9:00 a.m. ET

RBC 2026 Global Healthcare Conference
Format: Fireside chat
Date: Tuesday, May 19, 2026
Time: 3:35 p.m. ET

A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

(Press release, Karyopharm, MAY 12, 2026, View Source [SID1234665542])

Inhibikase Therapeutics Announces First Quarter 2026 Financial Results and Highlights Recent Activity

On May 12, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended March 31, 2026, and highlighted recent developments.

"We were excited to enroll the first patient in our registrational IMPROVE-PAH study last month, and are very pleased with our early progress obtaining country regulatory approvals to support initiation of clinical sites, including being one of the first companies to successfully take advantage of the new European Medicines Agency FAST-EU (Facilitating and Accelerating Strategic Trials in the European Union) initiative to accelerate multinational clinical trials," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With the recent approvals obtained in the first 16 countries worldwide, Inhibikase is well-positioned to initiate clinical site activations and seek to advance enrollment of IMPROVE-PAH. Later this week, we also look forward to the first of two new presentations of Phase 1 and pre-clinical studies of IKT-001 at the American Thoracic Society International Conference, to be held in Orlando, Florida."

Recent Developments

In late April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted to initiate our Phase 3 study in PAH, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), in 12 countries in the European Union. This approval brings the total country approvals for IMPROVE-PAH to 16, including the United States, Canada, New Zealand and Argentina, and further enables the Company to leverage this approval to seek the approval of an additional 3 countries in the European Union over the coming months to supplement our ongoing broader global country regulatory approval efforts.
The global IMPROVE-PAH study is a two-part adaptive Phase 3 study incorporating an initial 12-week dose titration phase designed to enable patients to get to the highest tolerable dose of IKT-001.
Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance ("PVR") at Week 24.
Part B of IMPROVE-PAH seamlessly begins following the last patient in Part A being enrolled and adopts an identical format to Part A, except the primary endpoint will be change in 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.
In addition to the titration benefits mentioned above, IMPROVE-PAH has the advantage of uninterrupted enrollment between Part A and Part B, together with the opportunity to undertake a sample size re-estimation for Part B based on Part A findings, if necessary.
In April 2026, Inhibikase announced that IMPROVE-PAH has been initiated with the recent activation of our first clinical sites in the United States, together with the enrollment of the first patient in the United States. Following the recent country approvals mentioned above, efforts to initiate clinical sites outside of the United States are now advancing.
In April 2026, Inhibikase submitted an Orphan Drug Designation ("ODD") application to the U.S. Food and Drug Administration for IKT-001 for treatment of PAH recognizing that PAH is a high unmet medical need impacting approximately 50,000 Americans.
Upcoming Presentations

IKT-001 pre-clinical and Phase 1 data will be featured into two presentations at the American Thoracic Society (ATS) International Conference in Orlando, Florida on May 17 and 20, 2026:
Safety, Tolerability, and Pharmacokinetics of IKT-001, a Novel Prodrug of Imatinib, in Healthy Volunteers, on May 17, 2026
In Vitro Pharmacology and Preclinical Efficacy of IKT-001 in Pulmonary Arterial Hypertension, on May 20, 2026.
Financial Results

Cash Position: As of March 31, 2026, cash, cash equivalents and marketable securities were $170.4 million.

Net Loss: Net loss for the quarter ended March 31, 2026, was $16.4 million, or $0.10 per share, compared to a net loss of $13.7 million, or $0.15 per share in the quarter ended March 31, 2025.

R&D Expenses: Research and development expenses were $10.8 million for the quarter ended March 31, 2026, compared to $10.5 million for the quarter ended March 31, 2025, which included a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the CorHepta acquisition.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2026 were $7.4 million, compared to $5.2 million for the quarter ended March 31, 2025.

(Press release, Inhibikase Therapeutics, MAY 12, 2026, View Source [SID1234665541])

IMUNON Reports First Quarter 2026 Financial Results and Provides Business Update

On May 12, 2026 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported financial results for the three months ended March 31, 2026, and highlighted recent business updates including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer.

"Enrollment in our pivotal Phase 3 OVATION 3 trial continues ahead of plan, reflecting patient interest and strong conviction among principal investigators and the broader medical community in IMNN-001’s therapeutic potential," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "Coupled with the unprecedented overall survival benefit observed in our Phase 2 (OVATION 2) study and an aligned path to BLA filing, IMNN-001 is well positioned to potentially transform the standard of care in advanced ovarian cancer."

RECENT DEVELOPMENTS

Final Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer – On March 25, 2026, the Company announced final data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT) in 112 women with newly diagnosed advanced ovarian cancer. IMUNON previously reported a median 11.1-month increase in overall survival (40.5 vs. 29.4 months) in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent and final data assessment, the Company reported a median 14.7-month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in overall survival (3.6 months delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone. Importantly, with these new efficacy results, IMNN-001 continues to show a highly favorable safety and tolerability profile across all clinical trials, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment of this disease.

IMUNON Sharpens Focus on its Promising Pivotal Phase 3 Ovarian Cancer Study – On February 5, 2026, the Company announced a strategic reorganization, the goal of which was to reduce operating expenses while supporting the Company’s focused strategy to rapidly advance the pivotal Phase 3 OVATION 3 clinical trial.

FIRST QUARTER 2026 FINANCIAL RESULTS

Net loss for the first quarter of 2026 was $4.3 million, or $0.84 per share, compared with a net loss of $4.1 million, or $3.15 per share, for the first quarter of 2025. Operating expenses were $4.3 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025.

Research and development expenses increased to $2.3 million in the first quarter of 2026 from $2.2 million in the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study.

General and administrative expenses remained unchanged at $2.0 million in each of the first quarters of 2026 and 2025.

Net cash used for operating activities was $4.0 million for the first quarter of 2026, compared with $2.8 million for the same period last year. This increase was primarily due to trial-related expenses associated with the OVATION 3 trial.

As of March 31, 2026, cash and cash equivalents were $4.8 million.

Conference Call and Webcast

The Company will be hosting a conference call to review first quarter 2026 financial results and provide a business update today, May 12, 2026, at 11:00 a.m. EDT. To participate in the call, please dial 800-715-9871 (U.S. and Canada/Toll Free) or 646-307-1963 (U.S./Toll) and ask for the IMUNON First Quarter 2026 Financial Results Call (Conference ID 8083343). A live webcast of the call will also be available.

(Press release, IMUNON, MAY 12, 2026, View Source [SID1234665540])

Immunome Reports First Quarter 2026 Financial Results and Provides Business Update

On May 12, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the quarter ended March 31, 2026, and provided a business update.

"This quarter reflects the progress we are making in building Immunome into a multi-program targeted oncology company," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "The NDA submission for varegacestat is an important milestone that reflects our commitment to improving the lives of patients with desmoid tumors, for whom new treatment options are still needed. We are also pleased that detailed Phase 3 RINGSIDE data were selected for oral presentation at ASCO (Free ASCO Whitepaper). In parallel, we continue to advance our ADC pipeline, with IM-1021 progressing in Phase 1 and IM-1617 recently receiving IND clearance."

Pipeline Highlights

Varegacestat:

•
In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors.
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Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.
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Data from RINGSIDE, the global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, have been selected for presentation in an oral abstract session at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
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In December 2025, Immunome announced positive topline results from RINGSIDE:
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The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001).
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The trial also met all key secondary endpoints, including achieving an objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review.
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In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review.
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Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in participants with B-cell lymphoma at multiple dose levels. Immunome expects to present initial lymphoma data for IM-1021 in 2026.

IM-3050: In March 2026, Immunome initiated the first clinical trial site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors.

IM-1617: In April 2026, Immunome received IND clearance for IM-1617 and plans to initiate a Phase 1 trial in the second quarter of 2026. IM-1617 is a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload.

Preclinical ADC Pipeline: Immunome expects to submit INDs for IM-1340 and IM-1335 in mid- and late 2026, respectively. The programs are each directed at undisclosed solid tumor targets and incorporate HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

First Quarter 2026 Financial Results

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As of March 31, 2026, cash and cash equivalents totaled $582.7 million. Immunome expects its current cash position to fund operations into 2028.
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Research and development expenses for the quarter ended March 31, 2026, were $46.4 million, including stock-based compensation costs of $3.7 million.
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General and administrative expenses for the quarter ended March 31, 2026, were $13.0 million, including stock-based compensation expense of $4.2 million.
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Immunome reported a net loss of $53.8 million for the quarter ended March 31, 2026.

(Press release, Immunome, MAY 12, 2026, View Source [SID1234665539])