On March 6, 2025 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, reported that the first patient has been dosed with the Company’s internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01 (Press release, Everest Medicines, MAR 6, 2025, View Source [SID1234650992]). EVM16CX01 is the first-in-human (FIH) trial for EVM16, conducted jointly at Peking University Cancer Hospital and Fudan University Shanghai Cancer center, to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 as a monotherapy and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors.

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EVM16 is a novel personalized therapeutic mRNA cancer vaccine internally developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest’s proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. The vaccine uses a lipid nanoparticle (LNP) delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth.

In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies.

Preclinical data also demonstrated that the combination of EVM16 and a PD-1 antibody has synergistic effects, which supports the combination of EVM16 with checkpoint inhibitors in clinical settings. In preclinical toxicity studies, repeated dosing with EVM16 was well tolerated and safe. Taken together, the preclinical studies show that EVM16 is safe and efficacious and has potential to bring benefits to cancer patients.

"The first patient dosed with the personalized mRNA cancer vaccine EVM16 represents a notable milestone in its clinical development. EVM16 is a customized vaccine based on each patient’s tumor-specific mutations, and using the cutting-edge mRNA technology, to activate the patient’s tumor-specific immune response to recognize and attack tumor cells." said Professor Shen Lin, Director of the Gastrointestinal Oncology Department at Beijing Cancer Hospital and Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology. " In preclinical studies, we are excited to discover that EVM16, when combined with PD-1 antibodies, demonstrated synergistic anti-tumor effects, further highlighting its broader potential for clinical application. We are confident in achieving positive outcomes in the upcoming clinical trials, bringing hope to cancer patients."

"In recent years, AI has become a major force in drug development, especially in the area of mRNA vaccines. AI is increasingly seen as a crucial tool for boosting research efficiency and accuracy, attracting substantial attention from both the biopharmaceutical industry and governments worldwide. Everest has demonstrated the clinical validation capabilities of its mRNA platform since 2021, with an emphasis on employing AI to identify tumor neoantigens. By continually optimizing its algorithms, the company has enhanced the precision of neoantigen recognition and validation, giving it a strong foundation and a competitive edge in developing mRNA-based cancer vaccines." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "EVM16 is the first personalized mRNA cancer vaccine internally developed by Everest. The first patient dosing marks a significant milestone in its clinical development of EVM16, indicating our proprietary tumor neoantigen AI-based algorithm system and mRNA technology platform have advanced to human trials. As a cancer vaccine candidate developed using our proprietary mRNA platform, we look forward to demonstrating EVM16’s therapeutic potential in upcoming clinical trials, with the goal of offering innovative treatment options to cancer patients worldwide and expand choices for those facing life-threatening diseases."

According to the Globocan’s data in 2022, there were 19.976 million new cancer cases globally, with 9.744 million cancer-related deaths1. Immunotherapy including checkpoint inhibitors has become an important part of treating some cancer types. However, they are only effective for some patients, and there is an urgent need to develop new generations of immunotherapies, such as personalized mRNA cancer vaccines, that have demonstrated early promise in clinical setting.

Everest Medicines is currently developing a range of mRNA cancer therapeutics, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) vaccines, immunomodulatory cancer vaccines, etc. Additionally, the company is working on next-generation lipid nanoparticle (LNP) delivery systems to enhance cell-mediated immune responses. Everest Medicines will submit an investigational new drug application for its TAA vaccines in China and the United States in 2025.

About EVM16

EVM16 is a novel personalized mRNA cancer vaccine independently developed by Everest Medicines. EVM16 contains neoantigens with high immunogenicity potential and predicted by Everest-proprietary algorithm EVER-NEO-1 and uses an LNP delivery system to efficiently deliver neoantigen-expressing mRNAs into the human body. After vaccination with EVM16, neoantigens-encoding mRNAs are delivered into human body to produce neoantigen peptides, which activate neoantigen-specific T cell immune responses to kill tumor cells, thereby inhibiting tumor growth.

About EVM16CX01 study

The study is a FIH, dose escalation and expansion study to evaluate the safety, tolerability, immunogenicity, and initial efficacy of EVM16 injection as a single and in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors. The primary objectives are to evaluate the safety and tolerability of EVM16 monotherapy and EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors, and to determine the recommended phase 2 dose (RP2D) of EVM16. The secondary objectives are to evaluate the immunogenicity of EVM16, and the initial efficacy of EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors.

On March 6, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter and full-year ended December 31, 2024, and highlighted recent business achievements (Press release, Elevation Oncology, MAR 6, 2025, View Source [SID1234650960]).

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"We continue to advance our Claudin 18.2 ADC program, EO-3021, for the treatment of advanced gastric/GEJ cancer in the earlier lines settings," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on the competitive anti-tumor activity and differentiated safety profile observed to date, we believe EO-3021 has the potential to benefit a broad patient population. Currently, we are evaluating EO-3021 in combinations with approved therapies in the first- and second-line settings, where we have a first-mover advantage and the opportunity to address significant markets, while also progressing our monotherapy cohort toward an additional data readout in the second quarter of 2025."

Mr. Ferra continued, "In the first quarter, we introduced prospective Claudin 18.2 testing to the monotherapy dose expansion cohort of our ongoing Phase 1 trial. This will further enhance our understanding of the patients most likely to benefit from treatment with our ADC and ultimately inform the design of future registrational studies. In addition, we continue to develop our HER3 ADC EO-1022 for the treatment of a wide range of HER3-expressing solid tumors and look forward to sharing preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting next month. We believe both EO-3021 and EO-1022 have the potential to elevate cancer care and are eager to share updates on both programs as we move through 2025."

Recent Business Achievements

Claudin 18.2 ADC EO-3021:

● In January 2025, Elevation Oncology implemented prospective Claudin 18.2 expression testing as part of the patient screening process in its ongoing Phase 1 clinical trial of monotherapy EO-3021. The dose expansion portion of the trial is now enrolling patients with ≥ 25% of tumor cells at IHC 1+/2+/3+, representing a moderately broader population compared to the exploratory efficacy analysis, which will continue to include patients with ≥ 20% of tumor cells at IHC 2+/3+.

● In January 2025, Elevation Oncology initiated dosing in the combination cohorts of its Phase 1 clinical trial of EO-3021. The combination cohorts are evaluating EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first-line setting and with ramucirumab, a VEGFR2 inhibitor, in the second-line setting for the treatment of advanced gastric/GEJ cancer.

● In December 2024, Elevation Oncology presented preclinical proof-of-concept data supporting the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Annual Congress 2024 (ESMO-IO). The in vivo data showed:

o Treatment with EO-3021 and DC101, a surrogate of VEGFR2 inhibitor ramucirumab, exhibited statistically superior tumor growth inhibition (TGI) compared to treatment with either EO-3021 or DC101 alone (TGI: 88.2% for EO-3021 in combination with DC101, compared to 20.1% for EO-3021 and 59.2% for DC101 alone).
o Treatment with EO-3021 and a PD-1 inhibitor exhibited statistically superior TGI compared to treatment with either EO-3021 or a PD-1 inhibitor alone (TGI: 79.9% for EO-3021 in combination with a PD-1 inhibitor, compared to 33.8% for EO-3021 and 25.0% for a PD-1 inhibitor alone). 92% (11/12) of mice treated with the combination of EO-3021 and a PD-1 inhibitor achieved a complete response (CR), compared to 50% (6/12) mice treated with EO-3021 monotherapy and 17% (2/12) mice treated with a PD-1 inhibitor alone.

HER3 ADC EO-1022:

● In December 2024, Elevation Oncology nominated EO-1022 as its HER3 ADC development candidate for the treatment of HER3-expressing solid tumors including breast cancer and non-small cell lung cancer. EO-1022 is designed to be a differentiated HER3 ADC, leveraging seribantumab’s desirable internalization properties, the latest site-specific ADC technology and the MMAE payload.

Expected Upcoming Milestones

EO-3021:

● Report additional safety and efficacy data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose escalation and expansion cohorts, in the second quarter of 2025.
● Report initial data from the combination cohorts of the Phase 1 clinical trial of EO-3021 in the fourth quarter of 2025 or the first quarter of 2026.

EO-1022:

● Present preclinical data for EO-1022 at AACR (Free AACR Whitepaper) Annual Meeting in the second quarter of 2025.
● File an IND application for EO-1022 in 2026.

Fourth Quarter and Full Year 2024 Financial Results

As of December 31, 2024, Elevation Oncology had cash, cash equivalents and marketable securities totaling $93.2 million, compared to $83.1 million as of December 31, 2023. The increase in cash reflects net proceeds of $44.2 million, which Elevation Oncology raised through its at-the-market (ATM) facility in the first half of 2024, partially offset by cash used to fund operating activities.

Research and development (R&D) expenses for the fourth quarter of 2024 were $6.6 million, compared to $4.7 million for the fourth quarter of 2023. The increase in R&D expenses in the fourth quarter of 2024 was primarily due to increased clinical trial expenses for the lead program EO-3021. For the year ended December 31, 2024, R&D expenses were $28.6 million, compared to $25.4 million for the year ended December 31, 2023. The increase was primarily driven by continuous investment in the lead and pipeline programs.

General and administrative (G&A) expenses for the fourth quarter of 2024 were $4.0 million, compared to $3.3 million for the fourth quarter of 2023. The increase in G&A expenses in the fourth quarter of 2024 was primarily due to increased personnel costs, including stock compensation expenses. For the year ended December 31, 2024, G&A expenses were $16.1 million, compared to $14.9 million for the year ended December 31, 2023. The increase was primarily due to increased professional fees and personnel expenses, partially offset by a decrease in premiums paid on directors’ and officers’ insurance.

Net loss for the fourth quarter of 2024 was $10.4 million, compared to $7.9 million for the fourth quarter of 2023.

On March 6, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Nuvation Bio, MAR 6, 2025, View Source [SID1234650993]).

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"Nuvation Bio had a transformative year in 2024, marked by significant milestones. We acquired AnHeart Therapeutics, reported positive pivotal data for taletrectinib, and submitted the NDA for taletrectinib, which was accepted by the U.S. FDA for Priority Review. This sets the stage for a potential U.S. commercial launch following our PDUFA goal date of June 23. We are also proud to now offer an Expanded Access Program in the U.S. for taletrectinib, addressing the urgent needs of patients with advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Beyond taletrectinib, we anticipate further updates in 2025 from our additional pipeline programs, including safusidenib and NUV-1511. With an exceptionally talented team and the closing of our recent non-dilutive financings of up to $250 million, we are well-positioned to continue toward our goal of improving the lives of people with cancer."

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

In December 2024, the U.S FDA accepted and granted Priority Review to the Company’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval). The PDUFA goal date of June 23, 2025, positions Nuvation Bio to commercialize taletrectinib in the U.S., if approved, in mid-2025.
In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for adult patients with locally advanced or metastatic ROS1+ NSCLC. As part of an exclusive license agreement, Innovent Biologics is commercializing taletrectinib in Greater China.
In February 2025, Nuvation Bio launched an EAP in the U.S., enabling eligible patients with advanced ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal TRUST-II study.
In March 2025, Nippon Kayaku completed submission of a MAA for taletrectinib for advanced ROS1+ NSCLC to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). As part of an exclusive license agreement, Nippon Kayaku will commercialize taletrectinib in Japan.
Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

Safusidenib is a potentially best-in-class, novel, oral, brain penetrant inhibitor of mutant IDH1.
Phase 2 study in patients with diffuse IDH1-mutant glioma is ongoing.
NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

NUV-1511, the Company’s first clinical-stage DDC, fuses a targeting agent to a widely used chemotherapy agent.
Phase 1/2 dose escalation study in patients with advanced solid tumors is ongoing.
NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

As previously announced, the Company is evaluating next steps for the NUV-868 program, including external partnership opportunities or further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.
Corporate Update:

In March 2025, Nuvation Bio secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners. The Company will receive $150 million in royalty interest financing and $50 million in debt upon U.S. FDA approval of taletrectinib by September 30, 2025, with access to an additional $50 million in debt at the Company’s option after first commercial sale. The royalty interest financing is expected to fully fund the U.S. commercial launch of taletrectinib. The Company’s pro forma cash balance is expected to fully fund development of the Company’s clinical-stage pipeline and create a path to potential profitability without a need for additional fundraising.
Fourth Quarter and Full Year 2024 Financial Results

As of December 31, 2024, Nuvation Bio had cash, cash equivalents, and marketable securities of $502.7 million.

For the three months ended December 31, 2024, research and development expenses were $29.3 million, compared to $15.4 million for the three months ended December 31, 2023. The increase was due to a $11.7 million increase in personnel-related costs driven by the acquisition of AnHeart Therapeutics, stock-based compensation and other benefits, a $2.1 million increase in third-party costs related to research services and drug manufacturing as a result of clinical trial expense for taletrectinib, and a $0.1 million increase in amortization of assembled workforce.

For the three months ended December 31, 2024, selling, general, and administrative expenses were $26.1 million, compared to $5.5 million for the three months ended December 31, 2023. The increase was due to a $9.5 million increase in personnel-related costs as a result of the acquisition of AnHeart Therapeutics, a $7.8 million increase in sales and marketing expenses, a $1.3 million increase in professional fees, a $1.2 million increase in other expenses as a result of the integration of AnHeart Therapeutics, a $0.7 million increase in foreign currency impact, and a $0.2 million increase in legal fees, offset by a $0.1 million decrease in insurance expense.

For the three months ended December 31, 2024, Nuvation Bio reported a net loss of $49.4 million, or $(0.15) per share. This compares to a net loss of $13.8 million, or $(0.06) per share, for the comparable period in 2023.

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

On March 6, 2025 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), a leading computational biology company aiming to revolutionize the development of life-science-based products, reported its financial results for the fourth quarter and full year period ended December 31, 2024 (Press release, Evogene, MAR 6, 2025, View Source [SID1234650961]).

Mr. Ofer Haviv, Evogene’s President and CEO, stated: "Today Evogene announced a change in the Chair position of its Board. I am pleased to welcome Mr. Nir Nimrodi as the new Chairperson of the Board and would like to express my gratitude to Ms. Sarit Firon for her invaluable contributions as Chairperson, I am pleased that she will continue to support Evogene in her role as a board member."

"2024 was a year of topline growth, reduction in cash use and value creation. We expect this trend to continue. I would like to share with you Evogene’s prospects for the near future", Mr. Haviv continued. "Evogene intends to direct its efforts by focusing further on the use of our ChemPass AI tech-engine in the field of AI powered drug discovery. We plan to enhance ChemPass AI tech-engine’s competitive advantage for the pharma market segment and expect these efforts to manifest in collaborations for small-molecule drug discovery, with bio-tech companies and academic institutions. I hope we’ll be able to announce such collaborations later this year. ​With respect to MicroBoost AI and GeneRator AI we intend to continue the support and development of these tech-engines based on the needs of our subsidiaries, with their funding."

"With regard to Evogene’s subsidiaries our intention is to focus on creating exit events for part of our subsidiaries. An exit event is expected to inject funds to further support Evogene’s activities. In addition, we plan to strengthen Casterra’s position as a profitable world leader in the castor oil market. Since Evogene holds 100% of Casterra we intend to use its profits to support Evogene’s activities, as well. Last, Evogene will also support subsidiaries’ efforts in their strategic fundraising activities. Part of the funds will be used by the subsidiaries to finance the development of Evogene’s tech-engines according to their needs."

"These strategic guidelines are expected to strengthen Evogene’s financial position. Through focus on a single engine and implementation of our expense reduction plan, we expect to substantially lower expenses, and through exit events, dividends, and technology license payments, we anticipate enhancing Evogene’s financials", Mr. Haviv concluded.

​Subsidiaries’ 2025 Targets:

Casterra Ag Ltd. – focuses on developing integrated solutions for large-scale castor bean farming, utilizing GeneRator AI tech-engine​.

– Increase castor seeds revenue in Africa with initial sales in Brazil and additional territories. ​

– Initiate PoC trials for grain farming for oil production, with a tier 1 partner in Kenya or Brazil. ​

– Develop new varieties addressing market needs; advance at least 2 new lines to the pre-commercial phase.​

– Develop a solution for reducing ricin quantity in meal, to be used as organic fertilizer.​

– Strengthen and improve seed production facilities in Kenya and Brazil.​

Lavie Bio Ltd. – a leading ag-biologicals company that develops microbiome-based, novel bio-stimulant and bio-pesticide products, utilizing Evogene’s MicroBoost AI tech-engine.

– Engage in a new collaboration agreement for fungicides (LAV311, LAV321).​

– Increase Yalos revenue with initial sales in soybean. ​

– Achieve R&D milestones in ICL collaboration toward commercial agreement. ​

– Achieve R&D milestones in Corteva collaboration toward licensing agreement. ​

AgPlenus Ltd. – specializes in developing novel and sustainable crop protection products, utilizing Evogene’s ChemPass AI tech-engine.

– Achieve second milestone in Corteva collaboration agreement.​

– Execute Bayer herbicide collaboration according to workplan.​

– Discover and advance 2-3 small molecules (hits) with new MoAs in Zymoseptoria program.​

– Engage in a new collaboration agreement for fungicide (Zymoseptoria).

Biomica Ltd. – a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics, utilizing Evogene’s MicroBoost AI tech-engine.

– Complete Phase 1 study in oncology program; obtain full results and additional supporting clinical data.​

– Submit an IND application to the US FDA and obtain FDA approval for the Phase 2 study.​

– Obesity and Longevity programs: complete discovery and in-vitro validations; seek partners for both programs. ​

Financial Highlights:

Cash Position: As of December 31, 2024, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $15.3 million. The consolidated cash usage during the fourth quarter of 2024 was approximately $4.6 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $1.5 million in cash during the fourth quarter of 2024. Cash usage for 2024, excluding Lavie Bio and Biomica, was approximately $10.4 million, marking a notable 17% decrease from approximately $12.5 million in 2023.

Revenue: Revenues for the 12 months of 2024 were approximately $8.5 million, an increase from approximately $5.6 million in the same period the previous year. This growth was primarily driven by revenues recognized from AgPlenus’s new collaboration with Bayer and increased Casterra’s revenues from the supply of castor seeds during the period. Revenues for the fourth quarter of 2024 were approximately $1.6 million, compared to approximately $0.6 million in the same period the previous year. The increase was mainly attributable to the increase in Casterra’s seed sales and the collaboration with Bayer, as mentioned above.

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R&D Expenses: Research and development expenses, net of non-refundable grants, for the 12 months of 2024 were approximately $16.6 million, a significant decrease from approximately $20.8 million in the 12 months of 2023. The decrease in expenses is mainly due to the cease of Canonic’s activities and a decrease in certain development expenses in Biomica, Evogene and Lavie Bio as compared to the same period the previous year. Research and development expenses, net of non-refundable grants, for the fourth quarter of 2024 were approximately $3.4 million, and decreased as compared to approximately $5.5 million in the same period in the previous year. The decrease is mainly attributable to decreased expenses in Lavie Bio, Biomica, Evogene and the cease of Canonic’s operations as mentioned above.

Sales and Marketing Expenses: Sales and Marketing expenses for the 12 months of 2024 were approximately $3.4 million, a slight decrease from approximately $3.6 million in the same period in the previous year. Sales and Marketing expenses for the fourth quarter of 2024 were approximately $0.7 million, a slight decrease from approximately $1.0 million in the same period in the previous year. The decrease is mainly due to the cease of Canonic’s activities.

General and Administrative Expenses: General and administrative expenses for the 12 months of 2024 increased to approximately $7.4 million from approximately $6.1 million in the same period of the previous year. The increase is mainly attributable to expenses recorded in Casterra due to a provision on a doubtful debt of a seed supplier and transaction costs related to Evogene’s fundraising that occurred in August 2024, totaling approximately $1.5 million. General and administrative expenses for the fourth quarter of 2024 increased slightly to approximately $1.4 million compared to approximately $1.2 million in the same period of the previous year.

Other Expenses: The decision to cease Canonic’s operations in the first half of 2024 resulted in other expenses of approximately $0.5 million, mainly due to impairment of fixed assets in the first quarter of 2024.

Operating Loss: The operating loss for the 12 months of 2024 was approximately $22.2 million, a decrease from approximately $26.5 million in the same period of the previous year, mainly due to increased revenues and decreased research and development expenses, offset by increased general and administrative expenses and other expenses, as mentioned above. The operating loss for the fourth quarter of 2024 was approximately $4.6 million, a decrease from approximately $7.6 million in the same period of the previous year, mainly due to increased revenues and decreased research and development expenses as mentioned above.

Financing Income / Expenses: Financing income, net for the 12 months of 2024 was approximately $4.2 million, compared to approximately $0.5 million in the same period of the previous year. Financing income, net for the fourth quarter of 2024 was approximately $4.6 million, compared to approximately $0.3 million in the same period of the previous year. The increase in financial income, net, during the 12-month period and the fourth quarter of 2024 as compared to the respective periods of 2023 was mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising. Pre-funded warrants and warrants were classified as a liability on the consolidated statements of financial position, were initially recorded at fair value and subsequently remeasured at each reporting period using the Black – Scholes option pricing model. As a result, during 2024 the Company recorded net financial income, related to pre-funded warrants and warrants of approximately $3.4 million.

Net Loss: The net loss for the 12 months of 2024 was approximately $18.1 million, compared to approximately $26.0 million in the same period of the previous year. The net loss for the fourth quarter of 2024 was approximately $5 thousand, compared to approximately $7.3 million in the same period of the previous year. The $7.9 million decrease in net loss for the 12 months of 2024 as compared to the 12 months of 2023 was primarily due to increased revenues, decreased research and development expenses and increased financial income, net related to warrants, offset by increased general and administrative expenses as mentioned above. The $7.3 million decrease in net loss for the fourth quarter of 2024 as compared to the fourth quarter of 2023 was primarily due to increased revenues, decreased research and development expenses and increased financial income, net related to warrants as mentioned above.

On March 6, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2024 (Press release, Adicet Bio, MAR 6, 2025, View Source [SID1234650994]).

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"In 2025 we plan to continue advancing our gamma delta 1 CAR T cell therapy programs, achieving key milestones and reporting preliminary data in autoimmune and oncology indications," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "The recent FDA Fast Track Designation for ADI-001 in refractory SLE with extrarenal involvement and in SSc highlights the significant unmet need for innovative, off-the-shelf therapies to treat autoimmune diseases. We are continuing to enroll LN patients in our ongoing Phase 1 trial in autoimmune diseases and look forward to sharing preliminary clinical data in the first half of 2025 and additional data in the second half of 2025. We expect to initiate enrollment for SLE, SSc, IIM and SPS patients in the second quarter and for AAV in the second half of the year, and to report clinical data from these additional cohorts in the second half as well."

Mr. Schor continued: "In addition, we are continuing to enroll patients in our Phase 1 trial of ADI-270 in relapsed or refractory metastatic/advanced ccRCC patients and remain on track to announce preliminary clinical data in the first half of 2025. With a strong clinical foundation and growing momentum, Adicet is well-positioned to transform treatment paradigms for patients battling autoimmune diseases and solid tumors."

Fourth Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

Continuing to advance phase 1 trial of ADI-001 in autoimmune diseases. In November 2024, Adicet announced the dosing of the first patient in the Phase 1 trial evaluating ADI-001 in LN. Enrollment for SLE, SSc, IIM, and SPS patients is expected to commence in the second quarter of 2025, with the initiation of AAV patient enrollment anticipated in the second half of 2025. The Company remains on track to share preliminary clinical data from the trial’s LN cohort in the first half of 2025. Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts are anticipated in the second half of 2025, subject to study site initiation and patient enrollment.
Fast Track Designation for ADI-001. In February 2025, Adicet received Fast Track Designation for ADI-001 for the treatment of refractory SLE with extrarenal involvement and SSc.
ADI-001 clinical biomarker data presented at the American College of Rheumatology (ACR) Convergence 2024. In November 2024, Adicet showcased an oral abstract at the ACR Convergence 2024 detailing ADI-001 clinical biomarker data. The findings demonstrated significant chimeric antigen receptor (CAR) T cell activation, robust tissue trafficking and complete CD19+ B cell depletion in secondary lymphoid tissue, underscoring ADI-001’s potential as a best-in-class off-the-shelf cell therapy for autoimmune diseases.
Solid tumor indications

First patient dosed in phase 1 trial of ADI-270 in metastatic/advanced ccRCC. In December 2024, Adicet announced the dosing of the first patient in the Phase 1 clinical trial evaluating the safety and efficacy of ADI-270 in adults with relapsed or refractory metastatic/advanced ccRCC. Preliminary clinical data from the trial are anticipated in the first half of 2025.
Presentation of ADI-270 data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Spring Scientific Meeting. In March 2025, Adicet will present two posters highlighting ADI-270 preclinical data at the SITC (Free SITC Whitepaper) 2025 Spring Scientific Meeting taking place March 12-14 in San Diego, CA.
Corporate updates

Appointed Julie Maltzman, M.D., as Chief Medical Officer. In December 2024, Adicet appointed Julie Maltzman, M.D., as Chief Medical Officer, who brings over two decades of experience in clinical development and regulatory affairs to the Company’s leadership team. Dr. Maltzman’s expertise spans across oncology and autoimmune diseases, encompassing all phases of drug development from early-stage research to global regulatory approvals and commercialization. Dr. Maltzman is leading Adicet’s clinical development functions to advance the company’s pipeline of allogeneic gamma delta CAR T cell therapies.
Financial Results for Fourth Quarter and Full Year 2024:

Three months ended December 31, 2024

Research and Development (R&D) Expenses: R&D expenses were $23.3 million for the three months ended December 31, 2024, compared to $24.8 million during the same period in 2023. The decrease in R&D expenses was primarily due to a $1.3 million decrease in expenses related to contract development and manufacturing organizations (CDMOs).
General and Administrative (G&A) Expenses: G&A expenses were $7.5 million for the three months ended December 31, 2024, compared to $6.8 million during the same period in 2023. The increase in general and administrative expenses was primarily due to a $0.5 million increase in professional fees.
Net Loss: Net loss for the three months ended December 31, 2024 was $28.7 million, or a net loss of $0.32 per basic and diluted share, including non-cash stock-based compensation expense of $3.8 million, as compared to a net loss of $29.5 million, or a net loss of $0.69 per basic and diluted share, including non-cash stock-based compensation expense of $4.9 million during the same period in 2023.
Twelve Months Ended December 31, 2024

Research and Development (R&D) Expenses: R&D expenses were $99.3 million for the year ended December 31, 2024, compared to $106.0 million for the year ended December 31, 2023. The $6.7 million decrease was primarily driven by a $7.7 million decrease in expenses related to CDMOs. This decrease was partially offset by a $0.6 million increase in lab expenses as well as a $0.5 million increase in professional fees.
General and Administrative (G&A) Expenses: G&A expenses were $28.3 million for the year ended December 31, 2024, compared to $26.5 million for the year ended December 31, 2023. The $1.8 million increase was primarily driven by a $0.9 million increase in professional fees for the period. There was also a net $0.4 million increase in payroll and personnel expenses and a $0.3 million increase in depreciation expense for the period.
Net Loss: Net loss for the year ended December 31, 2024 was $117.1 million, or a net loss of $1.33 per basic and diluted share, including non-cash stock-based compensation expense of $22.2 million, as compared to a net loss of $142.7 million, or a net loss of $3.31 per basic and diluted share, including non-cash stock-based compensation expense of $20.3 million during the same period in 2023.
Cash Position: Cash, cash equivalents and short-term investments were $176.3 million as of December 31, 2024, compared to $159.7 million as of December 31, 2023. The Company expects that current cash, cash equivalents and short-term investments as of December 31, 2024, will be sufficient to fund its operating expenses into the second half of 2026.