On February 26, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported key scientific contributions in 2024-2025 that are shaping the future of cancer immunotherapy (Press release, Agenus, FEB 26, 2025, View Source [SID1234650647]).

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Agenus is advancing a robust clinical pipeline targeting complementary mechanisms to fight cancer, including checkpoint inhibitors, immune activators, tumor microenvironment conditioning agents and cell therapies (via MiNK Therapeutics). Our most advanced antibody candidates, botensilimab (BOT) an Fc-enhanced CTLA-4 blocking antibody, and balstilimab (BAL), a novel, PD-1 inhibitor, are central to our efforts.

Driving Innovation of Cancer Immunotherapy

BOT has demonstrated differentiated mechanisms to enhance T cell priming, activation, and memory to drive a more effective immune response and was intentionally designed to mitigate toxicities associated with first-generation anti-CTLA-4 therapies.
BOT is currently being investigated as a monotherapy and in combination with widely used standard of care anti-PD-1, chemotherapy, and allogeneic cell therapy across multiple indications:
MSS colorectal cancer (CRC), pancreatic cancer (in combination with chemotherapy), and gastroesophageal (in combination with BAL and agent-797).
To date, BOT, either alone or in combination with BAL, has been evaluated in approximately 1,100 patients across more than 60 centers worldwide.
The combination targets complementary pathways and has demonstrated clinical responses across nine tumor types, including those historically considered immuno-oncology (IO) "cold" tumors or resistant to prior IO treatments.
Recent data presented at leading international conferences (ASCO, ESMO (Free ESMO Whitepaper), ASCO (Free ASCO Whitepaper) GI, AACR (Free AACR Whitepaper) IO) and featured in prestigious journals (Nature Medicine, Journal of Clinical Oncology, Cancer Discovery), showcase Agenus’ pivotal role in advancing IO research and expanding the reach of IO therapies to new patient populations.

Agenus’ Commitment to Advancing Immuno-Oncology Therapies

"The breadth and consistency of data we have presented over the past year reinforce the transformative potential of botensilimab and balstilimab in redefining treatment paradigms for patients battling historically treatment-resistance cancers. Decades of immuno-oncology research have set the stage for next-generation breakthroughs, and these latest findings with botensilimab and balstilimab represent a major advancement," said Dr. Steven O’Day, Chief Medical Officer, Agenus.

Dr. O’Day continues, "By leveraging our deep expertise in immune activation, we are unlocking responses in tumors previously resistant to immunotherapy. The results are even more promising as we move from treatment refractory metastatic disease to the neoadjuvant setting where we have the potential to reduce the need for adjuvant chemotherapy, preserve organs, and improve long-term survival. These results highlight an opportunity to reshape treatment paradigms and address the greatest unmet needs in oncology."

Breakthrough Findings Across Multiple Cancers

1. Colorectal Cancer:

Neoadjuvant Botensilimab Plus Balstilimab in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC) – NEST Study1 link

Conference: ASCO (Free ASCO Whitepaper) GI 2025
Lead Author: Dr. Erika Hissong, Weill Cornell Medicine
Key Findings: This investigator-initiated Phase 2 trial assessed BOT/BAL as neoadjuvant therapy in localized pMMR/MSS and dMMR/MSI-H CRC patients. The combination achieved high major pathological response (MPR) rates, and after median follow-up of 18 months (NEST-1) and 9 months (NEST-2) no recurrences were observed. Extended time to surgery correlated with improved pathological response. The study underscores the potential of dual checkpoint inhibition in neoadjuvant settings for CRC and the potential for non-surgical approaches for some patients​.

Neoadjuvant Botensilimab Plus Balstilimab in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (NEST-1 Trial)2 link

Conference: ESMO (Free ESMO Whitepaper) GI 2024
Lead Author: Dr. Pashtoon Kasi (presented by Dr. Mehraneh Jafari), Weill Cornell Medicine
Key Findings: This investigator-initiated Phase 2 trial assessed BOT/BAL as neoadjuvant therapy in resectable pMMR and dMMR colorectal cancer (CRC). A major pathological response (MPR) rate was observed across both cohorts, with no recurrences reported to date. Notably, extended time to surgery was associated with improved responses. Updated data was presented in 2025.

Preoperative Botensilimab (BOT) with or without Balstilimab (BAL) in Resectable, Locally Advanced pMMR or dMMR Colon Cancer – UNICORN Trial3 link

Conference: ASCO (Free ASCO Whitepaper) GI 2025
Lead Author: Dr. Filippo Ghelardi, Fondazione IRCCS Istituto Nazionale dei Tumori Milan
Key Findings: The Investigator-initiated Phase 2 UNICORN trial, explored short-course neoadjuvant BOT ± BAL in non-metastatic CRC patients. Results showed that the addition of BAL significantly enhanced response rates compared to BOT monotherapy, particularly in pMMR tumors. The pCR rate for the combination was 29% and 93% for pMMR and dMMR status, respectively, supporting the potential for non-operative management strategies in CRC​.

Phase 2 Botensilimab Plus Balstilimab in Refractory Microsatellite Stable (MSS) Metastatic Colorectal Cancer with No Liver Metastases4 link

Conference: ASCO (Free ASCO Whitepaper) GI 2025
Lead Author: Dr. Marwan G. Fakih, City of Hope Comprehensive Cancer Center
Key Findings: A Phase 2 study demonstrated deep and durable responses in MSS mCRC patients, demonstrating reproducible response rates (19%) and disease control rate (DCR) of 55% in this refractory metastatic CRC patient population; the standard of care arm had no responses. Notably, some patients treated with BOT/BAL exhibited no active disease over two years after starting the trial.

Phase 1 Study of Botensilimab Plus Balstilimab in Relapsed/Refractory Microsatellite Stable (MSS) Metastatic Colorectal Cancer5 link

Publication: Nature Medicine (September 2024)
Lead Author: Dr. Andrea J. Bullock, Beth Israel Deaconess Medical Center
Key Findings: This study evaluated BOT/BAL in heavily pretreated MSS mCRC patients, a historically checkpoint inhibitor-resistant tumor type. The ORR was 17%, and DCR reached 61%. The combination demonstrated durable responses with a manageable safety profile. In patients with non-active liver metastases (NLM) (n = 77), the ORR was 22% and the DCR was 73% with a 12-month OS rate of 69%. Conversely, in patients with active LM (n=24), ORR was 0% and the DCR was 25% with a 12-month OS rate of 30%. Learnings from this study helped define the P2 study population in MSS mCRC NLM.

A Phase I Trial of FOLFOX-3B: A Combination of Chemotherapy, VEGF(R) Inhibitors, and Checkpoint Blockade in MSS Metastatic Colorectal Cancer6 link

Conference: ASCO (Free ASCO Whitepaper) GI 2025
Lead Author: Dr. Marwan G. Fakih, City of Hope Comprehensive Cancer Center
Key Findings: This Phase I study evaluated the combination of BOT, BAL, FOLFOX chemotherapy, and bevacizumab in MSS metastatic CRC. Preliminary findings showed activity of the combination independent of liver metastases. The regimen demonstrated a 71% objective response rate (ORR) overall. 12/14 patients were pre-treated (FOLFOX "rechallenge"). The combination was well tolerated with only 1/14 patients having immune mediated diarrhea/colitis. Findings suggest that checkpoint blockade plus chemotherapy may enhance immunogenicity in MSS CRC and extend benefit to patients with liver metastases, warranting further investigation in the first line metastatic setting.

2. Gastroesophageal Cancer:

Biomarker Analysis from Phase 2 Study of agenT-797, Botensilimab Plus Balstilimab in PD-1 Refractory Gastroesophageal Cancer link

Conference: AACR (Free AACR Whitepaper) IO 2025
Lead Author: Dr. Samuel L. Cytryn, Memorial Sloan Kettering Cancer Center
Key Findings: This investigator-initiated Phase 2 trial demonstrated significant immune modulation, including robust tumor T-cell infiltration and increased activation of effector-memory T cells, suggesting the potential for overcoming PD-1 resistance.7

3. Sarcoma:

Botensilimab Plus Balstilimab in Relapsed/Refractory (R/R) Metastatic Sarcomas8 link

Publication: Journal of Clinical Oncology (January 2025)
Lead Author: Dr. Breelyn A. Wilky, University of Colorado Cancer Center
Key Findings: This Phase 1 study demonstrated promising efficacy of BOT in combination with BAL, in heavily pretreated sarcoma patients, including soft tissue sarcoma subtypes considered immunologically "cold". Notably, the overall response rate (ORR) was 19.2%, with a 27.8% ORR among angiosarcoma patients. The disease control rate (DCR) reached 65.4%, with a median progression-free survival (PFS) of 4.4 months and a 12-month overall survival (OS) rate of 69%.

Updated Efficacy and Safety of Botensilimab Plus Balstilimab in Metastatic Sarcoma9 link

Conference: ESMO (Free ESMO Whitepaper) 2024
Lead Author: Dr. Breelyn A. Wilky, University of Colorado Cancer Center
Key Findings: Data from an expanded Phase 1 study reaffirmed the activity of BOT/BAL across refractory metastatic sarcomas, including angiosarcoma and leiomyosarcoma. ORR reached 19.2%, with durable responses beyond 21 months in some patients.

4. Mechanistic Insights

Botensilimab, an Fc-Enhanced Anti–CTLA-4 Antibody, Is Effective against Tumors Poorly Responsive to Conventional Immunotherapy10 link

Publication: Cancer Discovery (December 2024)
Lead Author: Dr. Dhan Chand, Agenus Inc.
Key Findings: This landmark study highlighted how botensilimab’s unique design and Fc-enhancement overcomes the limitations of conventional checkpoint inhibitors through multiple immune-activating mechanisms. The research demonstrates that botensilimab potentiates T-cell responsiveness, reduces regulatory T cells, and enhances antigen-presenting cell activation across both preclinical models and patient samples. Clinical data showed significant efficacy in multiple treatment-refractory cancers, including those that progressed on prior immunotherapies. The findings establish a new mechanistic paradigm for expanding immunotherapy benefits to patients with traditionally immunotherapy-resistant cancers.

AGEN1721 – a first-in-class Fc-enhanced Bifunctional Antibody Targeting FAP and TGFβ, Remodels the Tumor Microenvironment to Overcome Cancer-associated Fibroblast-mediated Immune Suppression11 link

Conference: SITC (Free SITC Whitepaper) 2024
Lead Author: Dr. Priya Iyer, Agenus Inc.
Key Findings: AGEN1721, a novel dual-targeting agent, demonstrated the ability to modulate the tumor stroma, enhancing T-cell infiltration and antitumor responses in preclinical models. These findings provide a strong rationale for clinical development.

Additional updates in mCRC, NSCLC, melanoma, ovarian and pancreatic cancer are anticipated in the second half of 2025.

For further details on these studies, please visit www.agenusbio.com, www.minktherapeutics.com or access the respective publications and conference presentations.

On February 26, 2025 Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Interim Report and Half-Year Financial Results for the period ended 31 December 2024 (H1 FY25) (Press release, Starpharma, FEB 26, 2025, View Source;mc_eid=bf52dd3418 [SID1234650550]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"In the first half of FY25, Starpharma has made good progress in executing our strategy, aimed at maximising the value of our DEP assets, accelerating early asset development, and building long-term sustainability. I know our internal progress may not always be evident externally, but I can vouch for the dedication and hard work of everyone at Starpharma as we work towards achieving our strategic objectives.

"We have made important progress in advancing our DEP clinical assets, particularly DEP SN38, which has shown promising clinical outcomes in patients with high unmet need. A key regulatory milestone during the period was the recent meeting with the US Food and Drug Administration (FDA) regarding DEP SN38. The FDA provided feedback on the path to market for DEP SN38, confirming that the 505(b)(2) regulatory approval pathway is appropriate for DEP SN38 and the potential for Fast Track designation and accelerated approval. The positive response from the US regulator increases our confidence in the potential of DEP SN38 for treating platinum-resistant ovarian cancer. During the six months to December, our partner engagement through ongoing meetings and conference participation highlighted the importance of FDA feedback to potential partners for the commercialisation of DEP SN38.

"We are advancing our early-stage DEP programs, particularly in the area of radiopharmaceuticals, with the aim of initiating a first-in-patient clinical trial this calendar year. We are also expanding our research pipeline, positioning us well for future collaborations and long-term growth. Commercially, we anticipate the launch of VivaGel BV in key markets in the Middle East and continue to support sales of Viraleze online through digital marketing initiatives, which have resulted in a ~30% increase in revenue from the e-commerce channels compared to the prior corresponding period.

"We have focused on building a sustainable organisation and have sufficient capital to support our medium-term objectives, with a cash balance of $20.3 million as at 31 December 2024. The completion of multiple clinical programs in FY24 has led to a reduction in our research and development expenses, extending our cash runway. Over the past 12 to 18 months, we have implemented a number of cost-saving initiatives that are positively impacting our cash balance. Notably, our Corporate and Administration costs in this half-year period have decreased by $0.5 million compared to the prior corresponding period.

"Starpharma is committed to driving revenue growth, advancing our pipeline, and managing costs effectively to deliver improved and long-term value for our shareholders. We are focused on prioritising resources for our high-impact DEP programs, pursuing partnerships to advance our assets toward commercialisation, and increasing revenue through collaborations, licensing and product sales."

On February 26, 2025 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported a business update and announced financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Keros Therapeutics, FEB 26, 2025, View Source [SID1234650632]).

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"The efforts over the past year by the team at Keros have positioned us to continue to advance our promising pipeline of novel therapeutics," said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. "We are excited to report initial data from the ongoing Phase 1 clinical trial of KER-065 in healthy volunteers in the first quarter of 2025, which we believe can inform our advancement into a Phase 2 clinical trial in neuromuscular disease, with our initial focus on Duchenne muscular dystrophy. We continue to expect to report data from the Phase 2 TROPOS trial evaluating cibotercept (KER-012) in patients with pulmonary arterial hypertension, and we plan to evaluate the appropriate development strategy for cibotercept following that data readout."

Recent Corporate Highlights:

•Cash position strengthened: In February 2025, Keros received a $200.0 million upfront payment pursuant to the exclusive license agreement it entered into with Takeda Pharmaceuticals U.S.A., Inc. (the "Takeda Agreement") to further develop, manufacture and commercialize elritercept (KER-050) worldwide outside of mainland China, Hong Kong and Macau, which became effective on January 16, 2025. Based on current operating assumptions, the Company expects that its cash and cash equivalents as of December 31, 2024, together with the upfront payment received from the Takeda Agreement, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2029.

2024 Financial Results

Keros reported a net loss of $46.0 million for the fourth quarter and $187.4 million for the year ended December 31, 2024, as compared to a net loss of $40.2 million for the fourth quarter and $153.0 million for the year ended December 31, 2023. The increase in net loss for the fourth quarter and the year was largely due to increased research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals.

Keros generated revenue of $3.0 million for the fourth quarter and $3.6 million for the year ended December 31, 2024 compared to $0.1 million for the fourth quarter and $0.2 million for the year ended December 31, 2023. Revenue in 2024 was largely related to a milestone achieved under Keros’ license agreement with Hansoh (Shanghai) Healthtech Co., Ltd. ("Hansoh").

Research and development expenses were $45.6 million for the fourth quarter and $173.6 million for the year ended December 31, 2024, as compared to $37.5 million for the fourth quarter and $135.3 million for the year ended December 31, 2023. The increase in research and development expenses for the fourth quarter and the year was driven by the continued advancement of the Company’s pipeline, notably the TROPOS trial, the ongoing Phase 1 clinical trial of KER-065 and the progression of two Phase 2 clinical trials and the Phase 3 clinical trial of elritercept, as well as an increase in personnel costs and infrastructure to support operations and expansion of the Company’s pipeline.
General and administrative expenses were $10.7 million for the fourth quarter and $40.8 million for the year ended December 31, 2024, as compared to $9.1 million and $34.8 million for the fourth quarter and year ended December 31, 2023, respectively. The increase was primarily due to an increase in personnel expenses to support the Company’s organizational growth and achievement of its corporate goals, an increase in facilities, supplies and other office expenses due to the growth of the Company’s organization and an increase in professional fees.

Keros’ cash and cash equivalents as of December 31, 2024 was $559.9 million compared to $331.1 million as of December 31, 2023. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of December 31, 2024, together with the $200 million upfront payment from the Takeda Agreement, which the Company received in February 2025, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2029.

On February 26, 2025 Oncoinvent ASA (OSE: ONCIN) a clinical stage 2 radiopharmaceutical company developing novel radiopharmaceutical therapies against cancer, reported its fourth quarter 2024 results (Press release, Oncoinvent, FEB 26, 2025, https://www.oncoinvent.com/press-release/oncoinvent-asa-fourth-quarter-2024-update-and-results/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234650648]).

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On February 26, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported fourth quarter and full year 2024 financial results and provided a corporate update (Press release, Kura Oncology, FEB 26, 2025, View Source [SID1234650633]).

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"We are very pleased the KOMET-001 registrational trial achieved its primary endpoint. We look forward to sharing topline data at an upcoming medical conference and expect to submit a New Drug Application (NDA) in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML) next quarter," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "In parallel, we are advancing ziftomenib into registrational studies in the frontline (1L) setting. Approximately half of patients with newly diagnosed NPM1-mutated (NPM1-m) AML and 80% of patients with KMT2A-rearranged (KMT2A-r) AML will die from the disease within five years. Given this unmet need, we are pleased to have reached alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on key aspects of our Phase 3 trials, including the use of minimum residual disease (MRD)-negative complete response (CR) as a primary endpoint for potential accelerated approval in the U.S., with topline results anticipated in 2028. Our KOMET-017 trial is breaking new ground, and we and our partners at Kyowa Kirin are working as rapidly as possible to bring ziftomenib to AML patients worldwide."

Recent Highlights

Positive topline results from registration-directed trial of ziftomenib in R/R NPM1-m AML – Kura and Kyowa Kirin announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib in patients with R/R NPM1-m AML. The KOMET-001 trial achieved its primary endpoint, consistent with the targeted 20-30% CR/CR with partial hematological recovery (CRh) rate, and data have been submitted for presentation at ASCO (Free ASCO Whitepaper). The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports. Facilitated by the Breakthrough Therapy Designation status of ziftomenib in R/R NPM1-m AML, the Company completed its pre-NDA meeting with FDA and anticipates submitting an NDA in the second quarter of 2025.

Positive feedback from FDA for 1L combination trial designs – Earlier this month, Kura and Kyowa Kirin announced alignment with FDA on the KOMET-017 global trial protocol evaluating ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and/or KMT2A-r AML. This includes alignment on potential pathways for accelerated approval in the U.S. in both the KOMET-017-IC (intensive chemotherapy) and KOMET-017-NIC (non-intensive chemotherapy) trials by allowing the trials to use MRD-negative CR and CR, as primary endpoints, respectively. The companies also gained alignment with the EMA on the KOMET-017 protocol, and expect to initiate the KOMET-017 Phase 3 trials in the second half of 2025.

Positive clinical data for Phase 1 trial of ziftomenib in combination with standards of care – In December 2024, Kura Oncology and Kyowa Kirin announced encouraging clinical data from KOMET-007, a Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine/daunorubicin (7+3) and venetoclax/azacitidine in patients with NPM1-m and KMT2A-r AML. Among response-evaluable patients enrolled in the 7+3 combination cohort for patients with 1L NPM1-m or KMT2A-r adverse risk AML, 91% achieved a CR (100% for NPM1-m, 83% for KMT2A-r patients). Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the trial. The positive results from KOMET-007 reported at ASH (Free ASH Whitepaper) reinforce the companies’ commitment to evaluating ziftomenib across the continuum of 1L AML treatment options.

Global strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib in acute leukemias – In November 2024, Kura Oncology and Kyowa Kirin announced they entered into a global strategic collaboration to develop and commercialize ziftomenib (Kyowa Agreement), funding the expansive AML development program through U.S. commercialization in 1L combinations. Under the partnership, Kura retains leadership and key strategic rights to ziftomenib in the U.S. and preserves strategic flexibility, while enabling development and commercialization of ziftomenib across the continuum of care in acute leukemias, including both fit and unfit 1L indications, post-transplant maintenance setting and combinations with targeted therapies.

Preclinical data supporting opportunity for ziftomenib in treatment of gastrointestinal stromal tumors (GIST) – In October 2024, Kura reported preclinical data presented at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, supporting the potential for ziftomenib in combination with KIT inhibitors for GIST patients. The combination of ziftomenib and imatinib demonstrated robust and durable antitumor activity in imatinib-sensitive (1L) and imatinib-resistant (2L/3L) GIST patient-derived xenograft models. Sixty percent of patients develop resistance to imatinib within two years and ziftomenib has the potential to delay the onset of resistance to, or overcome resistance in patients pre-treated with, imatinib. In August 2024, Kura announced clearance by the FDA of an IND application and the Company remains on track to initiate the KOMET-015 trial evaluating ziftomenib plus imatinib in patients with advanced GIST, in the first half of 2025.

Clinical and preclinical data support combinations of farnesyl transferase inhibitors with targeted therapies – Despite multiple advances, innate and adaptive resistance remain a challenge for many classes of targeted therapies in cancer. A growing body of clinical and preclinical data demonstrates the potential of farnesyl transferase inhibitors as companion therapeutic agents to augment the antitumor activities of various targeted therapies and overcome resistance in combination. Enrollment in the FIT-001 trial evaluating our next-generation farnesyl transferase inhibitor KO-2806 continues to progress and the dose-escalation portion of the KURRENT-HN trial with tipifarnib is now complete. Kura expects to present the first clinical data for KO-2806 as a monotherapy and in combination, as well as clinical data from the KURRENT-HN trial, in the second half of 2025.
Financial Results

Collaboration revenue from our Kyowa Kirin partnership for the fourth quarter and full year 2024 was $53.9 million, compared to no revenue in 2023.

Research and development (R&D) expenses for the fourth quarter of 2024 were $52.3 million, compared to $32.5 million for the fourth quarter of 2023. R&D expenses for the full year 2024 were $170.0 million, compared to $115.2 million for the prior year.

General and administrative (G&A) expenses for the fourth quarter of 2024 were $24.1 million, compared to $14.2 million for the fourth quarter of 2023. G&A expenses for the full year 2024 were $77.1 million, compared to $50.6 million for the prior year.

Net loss for the fourth quarter of 2024 was $19.2 million, compared to a net loss of $42.8 million for the fourth quarter of 2023. Net loss for the full year 2024 was $174.0 million, compared to a net loss of $152.6 million for the prior year.

Net loss for the fourth quarter and full year 2024 included non-cash, share-based compensation expense of $8.6 million and $33.9 million, respectively. This compares to $7.2 million and $28.1 million for the same periods in 2023.

As of December 31, 2024, Kura had cash, cash equivalents and short-term investments of $727.4 million, including the upfront payment of $330.0 million from Kyowa Kirin, compared to $424.0 million as of December 31, 2023.

Based on our current plans, we believe our cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient to enable us to fund our current operating expenses into 2027, and combined with anticipated collaboration funding under the Kyowa Agreement, should support our ziftomenib AML program through commercialization in the 1L combination setting.
Forecasted Milestones

Submit an NDA for ziftomenib in R/R NPM1-m AML in the second quarter of 2025.

Present topline data from KOMET-001 Phase 2 registration-directed trial in R/R NPM1-m AML in the second quarter of 2025.

Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with intensive chemotherapy (7+3) at a medical meeting in the second quarter of 2025.

Initiate the KOMET-015 trial evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025.

Initiate two independent Phase 3 registration-enabling trials in 1L intensive (KOMET-017-IC) and non-intensive (KOMET-017-NIC) AML in the second half of 2025.

Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with venetoclax and azacitidine at a medical meeting in the second half of 2025.

Nominate a development candidate for next-generation menin inhibitor program in diabetes in mid-2025.

Initiate one or more expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the first half of 2025.

Present data from the Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS mutations in the second half of 2025.

Present data from the Phase 1 trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma in the second half of 2025.

Present data from the dose escalation portion of KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) in the second half of 2025.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, February 26, 2025, to discuss the financial results for the fourth quarter and full year 2024 and to provide a corporate update. The live call may be accessed by dialing (800) 579-2543 for domestic callers and (785) 424-1789 for international callers and entering the conference ID: KURAQ4. A live webcast and archived replay of the event will be available here or online from the investor relations section of the company website at www.kuraoncology.com.