On May 12, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported financial results for the first quarter ended March 31, 2026, and highlighted recent clinical progress.

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"This quarter, we built momentum with achievement of key milestones advancing azenosertib in our registration-intended Phase 2 and Phase 3 trials for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC)," said Julie Eastland, Chief Executive Officer of Zentalis. "Our core focus is on bringing a convenient, oral, non-chemotherapy treatment option to approximately 50% of PROC patients who are Cyclin E1-positive and may experience poorer prognosis and limited benefit from standard-of-care therapies. Pivotal dose selection supports our regulatory strategy, positioning us to pursue accelerated approval through the DENALI Part 2 trial while simultaneously advancing ASPENOVA as our confirmatory trial—together charting a pathway to bring a potential first-in-class therapy to market for this underserved patient population. Following dose selection, we initiated pre-commercial launch preparedness activities to add commercial capabilities to the organization, scale manufacturing capacity and advance Cyclin E1 companion diagnostic market development. Beyond the lead indication, we see substantial opportunity for strategic expansion of azenosertib into platinum-sensitive or first-line maintenance settings of ovarian cancer, additional tumor types, and combination approaches."

"With a cash position of $211.8 million as of March 31, 2026, we have runway into late 2027 and the resources to support execution of key milestones, most importantly the DENALI Part 2 topline readout, and ongoing trials," Ms. Eastland continued.

Clinical Development Progress
•Pivotal Dose Selected for Registration-Intended Azenosertib Monotherapy Program in Cyclin E1-Positive PROC: In April 2026, selected 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2) as the pivotal study dose for azenosertib monotherapy in patients with Cyclin E1-positive PROC based on a pre-specified interim analysis from DENALI Part 2a that showed a meaningful, clearly differentiated response rate at 400mg QD 5:2 and comparable safety profiles across both dose groups. The analysis revealed observed improvements in several key measures, including a discontinuation rate due to adverse events at approximately half the rate reported in DENALI Part 1b and no treatment-related deaths. Concurrently, the Company expanded DENALI Part 2 to include Part 2c, a new cohort broadening inclusion to approximately 40 patients previously treated with a taxane-containing regimen for PROC, to maintain alignment between the study population and the evolving treatment landscape. DENALI Parts 2b and 2c are currently enrolling. DENALI Part 2 is designed to support a potential accelerated approval pathway in the Cyclin E1 biomarker-selected patient population, subject to regulatory review. The Company expects to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout by year-end 2026.
•ASPENOVA Phase 3 First Patient Dosed: In May 2026, announced the first patient was dosed in the Phase 3 ASPENOVA confirmatory trial designed to satisfy FDA requirements for potential conversion to full approval and to support approval in major ex-US markets. ASPENOVA is a randomized, controlled Phase 3 trial that is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan) in patients with Cyclin E1-positive PROC. The trial is currently enrolling.
•MUIR Part 2 dose expansion evaluating azenosertib in combination with bevacizumab as maintenance therapy in ovarian cancer. MUIR is a multi-part, open-label Phase 1b clinical trial evaluating the safety, efficacy and preliminary clinical activity of azenosertib as a combination therapy in patients with ovarian cancer. The dose expansion cohort of Part 2 is currently open for enrollment of azenosertib in combination with bevacizumab in second-line platinum-sensitive ovarian cancer (PSOC) patients for maintenance treatment, whose disease progressed while on a PARP inhibitor.

Medical Meeting Presentations Supporting Pipeline Strategy
•AACR 2026: Presented two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting featuring: (1) compelling preclinical data showing azenosertib combinations can induce complete tumor responses in a model resistant to emerging antibody-drug conjugate (ADC) therapies in triple-negative breast cancer (TNBC), supporting the potential for pipeline expansion beyond ovarian cancer; and (2) real-world data from two independent cohorts demonstrating that Cyclin E1-positive ovarian cancer patients experience significantly worse clinical outcomes, independent of CCNE1 gene amplification status, reinforcing the potential for azenosertib to address the unmet need for these patients.
•ASCO 2026 Abstract Acceptance: Announced that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has accepted an abstract for presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting featuring results from Part 1 of the Phase 1b MUIR trial, focusing on an evaluation of azenosertib in combination with paclitaxel in platinum-resistant ovarian cancer (PROC). The data will showcase combinability and activity in an all-comer setting, demonstrating the broad potential for azenosertib in multiple lines of ovarian cancer and other tumor types.

First Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities were $211.8 million as of March 31, 2026, compared to $245.9 million as of December 31, 2025. The Company believes that its existing cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operating expenses and capital expenditure requirements into late 2027.
•Research and Development Expenses: Research and development (R&D) expenses for the three months ended March 31, 2026 were $28.7 million, compared to $27.2 million for the three months ended March 31, 2025. The increase of $1.5 million was primarily due to an increase of $6.8 million related to clinical expenses and drug manufacturing, including costs associated with advancing the DENALI and ASPENOVA trials. This increase was partially offset by decreases of $3.9 million for personnel expense, of which $1.2 million was non-cash stock-based compensation, a decrease of $1.2 million related to a one-time impairment charge recorded in Q1 2025, and a decrease of $0.2 million for allocated overhead.
•General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2026 were $9.1 million, compared to $10.6 million during the three months ended March 31, 2025. This decrease of $1.5 million was attributable to a decrease of $2.0 million in personnel expense, of which $1.2 million was non-cash stock-based compensation. The decrease was partially offset by an increase of $0.5 million related to consulting, outside services and other allocated costs.
•Total Operating Expenses: Total operating expenses were $37.9 million for the three months ended March 31, 2026, compared to $45.6 million for the three months ended March 31, 2025. Total operating expenses for the first quarter of 2025 included a non-recurring $7.8 million expense associated with the strategic restructuring announced in January 2025.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.

Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff.

Part 2, in total, is designed to support accelerated approval, pending positive study outcomes and further discussions with the FDA. The study design consists of the following parts:
•Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
•Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort is currently enrolling.
•Part 2c: Broadening study population, which is expected to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling.

Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 (2a, 2b, 2c) and provide a topline readout by year-end 2026.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About ASPENOVA Clinical Trial
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was based on feedback from the U.S. FDA regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval.

About MUIR Clinical Trial
MUIR (NCT04516447) is a multi-part, open-label Phase 1b clinical trial evaluating the safety, efficacy and preliminary clinical activity of azenosertib combinations in patients with ovarian cancer.
Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.

Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion. The dose expansion portion is currently open for enrollment.

(Press release, Zentalis Pharmaceuticals, MAY 12, 2026, View Source [SID1234665563])

On May 12, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines for the treatment of cancer, reported that initial dose escalation data from its Phase 1/1b trial of BH-30236, a macrocyclic CDC-link kinase (CLK) inhibitor, in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndrome (HR-MDS) will be presented during a poster session on June 12, 2026, at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden. Additionally, BH-30236 has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of AML.

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"We are highly encouraged by the initial safety data and early signs of anti-leukemic activity observed with BH-30236, both as a monotherapy and in combination with venetoclax," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "By modulating aberrant alternative mRNA splicing, our potential first-in-class CLK inhibitor, BH-30236, represents a novel approach for patients with relapsed or refractory AML and higher-risk MDS, who face a significant unmet medical need. We look forward to presenting additional data from more patients with longer follow-up at the meeting and to advancing BH-30236 in both monotherapy and combination settings."

BH-30236 was designed to target the CLK kinase family, leading to the modulation of aberrant alternative mRNA splicing, a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors. Our Phase 1/1b trial evaluating BH-30236 was initiated following encouraging preclinical data, including evidence of synergistic activity between BH-30236 and venetoclax, a BCL-2 inhibitor and an established standard of care therapy for patients with AML. The trial is currently enrolling patients in dose escalation, evaluating BH-30236 as both a monotherapy and in combination with venetoclax.

As of the January 23, 2026 cutoff date for the EHA (Free EHA Whitepaper) abstract submission, 28 patients received BH-30236 monotherapy at 5-120 mg on a continuous daily administration schedule (QD) and 11 patients received BH-30236 at 20-60mg QD in combination with venetoclax. Initial findings demonstrated:

BH-30236 was generally well tolerated as both a monotherapy and in combination with venetoclax, with most treatment-related adverse events being low-grade and manageable, as well as one grade 3 DLT (diarrhea)
Dose escalation showed predictable pharmacokinetics without drug accumulation or reduction, and no significant drug-drug interactions were observed with venetoclax
Early signs of clinical activity were observed:
In the monotherapy cohort, 29% (n=5) of evaluable patients achieved at least a 50% reduction in bone marrow blast counts, including one HR-MDS patient treated at 60 mg with ongoing blast count reduction with duration of treatment 7.6 months.
In the combination cohort, 55% (n=5) of evaluable patients experienced at least a 50% blast reduction, including one patient refractory to all prior therapy including venetoclax, who achieved a minimal residual disease (MRD)-negative complete remission.
"In March of this year, the U.S. Food and Drug Administration granted Orphan Drug Designation to BH-30236 for the treatment of acute myeloid leukemia, underscoring the need for new therapies in this rare malignancy," said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. "This designation is an important milestone that reflects the potential of BH-30236 to address a significant unmet need and provides benefits that may support our ongoing clinical development, as well as potential market exclusivity upon approval."

Poster Session Details

Title: A First-in-Human Study of the Oral CLK Inhibitor BH-30236 in Adults with Relapsed/Refractory Acute Myeloid Leukemia or Higer-Rish Myelodysplastic Syndrome: Monotherapy and Venetoclax Combination
Presenting Author: Eytan M. Stein, MD, Chief of the Leukemia Service, Associate Attending Physician, Clinical Investigator and Director of the Program for Drug Development in Leukemia on the Leukemia Service at Memorial Sloan Kettering Cancer Center
Date & Time: Friday, June 12 from 12:45 to 1:45 ET / 18:45 – 19:45 CEST
Abstract Code: PF494
About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 is designed to modulate aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine. BH-30236 is currently in clinical development for the treatment of relapsed or refractory AML (R/R AML) and HR-MDS.

BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration has granted orphan drug designation to BH-30236 for the treatment of AML.

(Press release, BlossomHill Therapeutics, MAY 12, 2026, View Source [SID1234665580])

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported first quarter 2026 financial results and provided a corporate update.

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"In its first full quarter of commercial availability, KOMZIFTI generated $5.8 million in net revenue, with early launch dynamics indicating growing physician adoption and utilization patterns based on product profile. We believe these early signals support KOMZIFTI’s potential to become the leading therapy in relapsed/refractory NPM1-mutant AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Supported by a robust clinical development program designed to establish it as a broadly combinable backbone across the AML treatment continuum, and with multiple data readouts expected this year across frontline and combination settings, we are well positioned for the next phase of growth."

Recent Developments

KOMZIFTI Launch Performance (First Quarter 2026)

KOMZIFTI delivered a strong first full quarter of commercial performance, with early indicators supporting adoption and continued momentum:

$5.8 million in net product revenue in the first full quarter of commercial sales

85 new patient starts and 157 total prescriptions, reflective of both uptake and repeat use

> 93% payer coverage achieved, with favorable positioning across plans covering more than 12 million lives
Early market dynamics, including repeat prescribing, expanding use across treatment settings, initial combination use and instances of switching from other menin inhibitors, indicate growing physician adoption based on product profile.

Advancing Ziftomenib Across the Acute Myeloid Leukemia (AML) Treatment Continuum

Kura continues to execute on its strategy to establish ziftomenib as a broadly combinable backbone therapy across AML:

KOMET-017 (Phase 3 Frontline Program): Ongoing site activation and patient enrollment for both studies across global sites with strong early progress

KOMET-008 (FLT3 Relapsed/Refractory [R/R] Population): Ongoing enrollment evaluating ziftomenib combined with gilteritinib in patients with R/R AML harboring FLT3-ITD/NPM1 co-mutations

KOMET-007 (FLT3 Frontline Population): Ongoing enrollment evaluating ziftomenib combined with quizartinib plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1 co-mutations

Japanese Registrational Trial: First patient dosed in Phase 2 trial (jRCT2031250550) for treatment of R/R NPM1-m AML, representing a significant step toward bringing a potential new treatment option to patients in Japan
Multiple clinical data readouts expected in 2026 across combination regimens and treatment settings, supporting ziftomenib’s potential use broadly across the AML landscape.

Solid Tumor Pipeline Progress

Kura continues to advance darlifarnib as a novel approach to overcoming resistance in targeted therapy:

Proof-of-mechanism data for darlifarnib in combination with cabozantinib: At the 2026 International Kidney Cancer Symposium: Europe (IKCS) conference, Kura presented proof-of-mechanism data for darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma previously treated with cabozantinib

The data support darlifarnib’s potential to overcome resistance and resensitize tumors to VEGF TKI therapy, with
44% objective response rate (ORR)
94% disease control rate (DCR)
Tumor shrinkage in 75% of patients
FIT-001 Phase 1b dose expansion: Enrollment is ongoing
2026 Commercial Priorities and Anticipated Development Milestones

Kura expects multiple value-driving catalysts in 2026 across commercial development and clinical development:

KOMZIFTI Commercial Execution

Drive clear differentiation within the menin inhibitor class
Deliver sustained quarter-over-quarter growth in revenue and adoption
Establish leading class share in R/R NPM1-m AML
Ziftomenib – Frontline AML

Present updated results for ziftomenib / 7+3 combination in frontline NPM1-m/KMT2A-r AML (KOMET-007) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in June 2026
Ziftomenib – Relapsed/Refractory AML

Publish data for ziftomenib plus venetoclax + azacitidine in R/R NPM1-m AML (1H 2026)
Present preliminary KOMET-008 data for ziftomenib and gilteritinib combination in R/R NPM1-m/FLT3-m AML (2H 2026)
Ziftomenib and Menin Inhibition – Expansion Beyond AML

Continue enrollment of KOMET-015 evaluating ziftomenib + imatinib in gastrointestinal stromal tumors (GIST)
Progress preclinical development of next-generation menin inhibitor for use in other solid tumors
Darlifarnib

Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in May 2026
Present updated Phase 1a data with the first report of long-term follow-up for darlifarnib plus cabozantinib in advanced RCC (2H 2026)
KO-7246 (Next-Generation Menin Inhibitor)

Advance KO-7246 into IND-enabling studies for diabetes and cardiometabolic disease
Present additional preclinical data for menin inhibitors in diabetes
First Quarter 2026 Financial Results

Net product revenue: $5.8 million, compared to none for Q1 2025
Collaboration revenue: $12.5 million, compared to $14.1 million for Q1 2025
R&D expenses: $65.3 million, compared to $56.0 million for Q1 2025, primarily driven by advancement of ziftomenib combination trials, including KOMET-017
SG&A expenses: $31.6 million, compared to $22.8 million for Q1 2025, reflecting commercialization-related investments
Net loss: $73.3 million, compared to $57.4 million for Q1 2025. Net loss includes $8.4 million in non-cash, share-based compensation expense compared to $7.8 million for the same period in 2025.
As of March 31, 2026, Kura had $580.8 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.

The Company believes its cash, cash equivalents and short-term investments as of March 31, 2026, when combined with $180 million in anticipated payments under the collaboration agreement with Kyowa Kirin, will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234669309])

On May 12, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company"), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that the Company’s management is scheduled to participate in three upcoming investor conferences.

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· B. Riley Commercial/Late-Stage Oncology Best Ideas Summit: One-on-one meetings on May 18th

· Stifel 2026 Virtual Targeted Oncology Forum: One-on-one meetings and fireside chat at 10:30 am EDT on May 19th

· Jefferies Global Healthcare Conference in New York: One-on-one meetings and presentation at 8:10 am EDT on June 3rd

The webcasts for the fireside chat and presentation can be accessed by visiting the Events page in the Investor Relations section of Ascentage Pharma’s website.

(Press release, Ascentage Pharma, MAY 12, 2026, View Source [SID1234665524])

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.

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"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.
•
Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.
•
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.
•
In December 2025, Immunome announced positive topline results from RINGSIDE:
o
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).
o
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.
o
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.
o
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

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