On March 6, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has received a Notice of Intent to Grant for the European patent application titled, "Method of Reconstituting Liposomal Annamycin" (Press release, Moleculin, MAR 6, 2025, View Source [SID1234650970]). The grant is subject to payment of fees and completion of final amendments and formalities. Such grant will enhance the global exclusivity of Annamycin with the potential to be a next generation, non-cardiotoxic treatment for certain cancers.

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When issued, the patent claims will cover methods of making liposomal Annamycin suspension as well as the resulting compositions for use in the treatment of cancers, with a base patent term currently extending until June 2040, subject to extension to account for time required to fulfill requirements for regulatory approval. Moleculin’s novel drug candidate is being positioned to become the first ever non-cardiotoxic anthracycline to be approved and is currently being developed for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). Additional preclinical studies performed at a world-renowned cancer center indicate Annamycin may be a potential treatment for many more other types of cancers. The new chemical entity uses a unique lipid-based delivery technology and has shown the potential to be used in a wide range of cancers. In addition to the expected European patent and previously issued U.S. patents, Moleculin has additional patent applications related to Annamycin pending in the U.S., Europe and in major jurisdictions worldwide.

Wally Klemp, Chairman and CEO of Moleculin, said "Acknowledgment by the European Patent Office of the innovation underlying Annamycin is an important milestone for Moleculin, underscoring the importance and proprietary nature of the innovation that makes this next generation anthracycline possible. We expect Europe to be an important market for Annamycin and look forward to making an important new treatment available to patients in this region. This enhancing of our exclusivity for Annamycin is exciting when coupled with our continued expectation for an initial data readout for the MIRACLE trial in the second half of 2025."

The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

On March 6, 2025 Integral Molecular, a leader in antibody discovery against membrane proteins, reported that its out-licensed anti-Claudin 6 (CLDN6) bispecific antibody, CTIM-76, has been dosed in the first patient in a Phase 1 clinical trial by its licensing partner, Context Therapeutics Inc (Press release, Integral Molecular, MAR 6, 2025, View Source [SID1234650968]). This milestone is part of a Phase 1 dose escalation and expansion trial enrolling patients with advanced or metastatic ovarian, endometrial, and testicular cancers.

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CLDN6 is a structurally complex protein that is expressed in multiple cancers but absent from healthy tissue, making it an attractive drug target. However, targeting CLDN6 is challenging because numerous related proteins are present in healthy tissues.

Using their MPS Antibody Discovery platform, Integral Molecular isolated a lead molecule targeting a unique CLDN6 epitope to deliver potential best-in-class specificity compared with other molecules undergoing clinical development. Under a licensing agreement, Context Therapeutics Inc. is leading clinical development of CTIM-76, following the successful completion of IND-enabling studies.

CTIM-76 was generated using Integral Molecular’s proprietary technologies for discovering therapeutics against challenging targets:

MPS Antibody Discovery platform tailored to produce robust immune responses even against the most complex proteins and rare epitopes
Bispecific antibody engineering strategies that assess numerous bispecific antibody stoichiometries and formats in vitro and in vivo
Selection for exquisite specificity using Integral Molecular’s Membrane Proteome Array that screens biologics for reactivity against 6,000 native membrane proteins
"Our antibody discovery platform continues to advance untapped targets across oncology, autoimmune diseases, and other therapeutic areas to discover breakthrough treatments for patients," said Joseph Rucker, PhD, Vice President of R&D at Integral Molecular. "We are proud to work with partners like Context Therapeutics who are bringing novel therapeutics to the clinic."

On March 6, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma ("IHCC") patients with fibroblast growth factor receptor ("FGFR")2 fusion/rearrangement (Press release, Hutchison China MediTech, MAR 6, 2025, View Source [SID1234650967]).

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The study is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced IHCC patients with FGFR2 fusion/rearrangement. Primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS). A total of 87 patients were enrolled into the registration phase of the study. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.

The first patient received the first dose in March 2023 and HUTCHMED expects to announce topline results from the study around the end of 2025. If favorable, the results could enable a New Drug Application submission to China’s National Medical Products Administration (NMPA).

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings.

HUTCHMED currently retain all rights to fanregratinib worldwide.

About IHCC with FGFR2 Fusion/Rearrangement

IHCC is one of the subtypes of primary bile duct cancer. In China, an estimated 61,900 newly diagnosed IHCC occurred in 2015 and the overall IHCC incidence increased by 9.2% per year between 2006 and 2015.1 FGFR2 fusion has been reported to have a prevalence of 10-15% in IHCC patients.

On March 6, 2025 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial update and corporate outlook in conjunction with the Company’s 10-K filing for the year ending December 31, 2024 (Press release, Foghorn Therapeutics, MAR 6, 2025, View Source [SID1234650962]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"In 2024, we continued our strong execution across our pipeline, which has set us up for an exciting 2025. The Phase 1 trial of FHD-909, a first-in-class oral selective SMARCA2 inhibitor for SMARCA4 mutated cancers with NSCLC as the primary target population, is enrolling well. Preclinical combination data of FHD-909 with pembrolizumab and novel KRAS inhibitors will be presented at AACR (Free AACR Whitepaper)," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "We are continuing to progress our Selective CBP degrader and Selective EP300 degrader towards IND and will present additional preclinical data at AACR (Free AACR Whitepaper). Our Selective ARID1B degrader program, which addresses a synthetic lethal target implicated in up to 5% of all solid tumors, continues to make exciting advancements, and we expect to provide a program update later in 2025. Our balance sheet remains strong, and we look forward to sharing progress for programs throughout the year."

Recent Corporate Updates

Dosed first patient with FHD-909 in October 2024. The first patient was dosed with FHD-909 in the Phase 1 open-label, multicenter trial for SMARCA4 mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target patient population, in October 2024.

Selective degradation of ARID1B achieved. Earlier this year, Foghorn announced that the company has achieved selective degradation of ARID1B and will provide a program update during 2025.

Presented at the 7th Annual Targeted Protein Degradation (TPD) Summit. In October 2024, Foghorn participated in multiple sessions at the 7th Annual TPD Summit, including a CEO Think Tank keynote session entitled "A Strategic Look at Targeted Protein Degradation & Induced Proximity Field" featuring Foghorn’s CEO Adrian Gottschalk, and a presentation by Steve Bellon, Foghorn’s Chief Scientific Officer on the recent developments from Foghorn’s degrader pipeline.

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral selective SMARCA2 inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors. Patients diagnosed with NSCLC with a SMARCA4 mutation tend to have a worse prognosis.
•Advancing Phase 1 trial. First patient dosed in October 2024 in the Phase 1 trial for FHD-909 in SMARCA4 mutated cancers, with NSCLC as the primary target population.
◦Ongoing first-in-human Phase 1a/b open-label, multicenter trial design for FHD-909 will be presented at the AACR (Free AACR Whitepaper) Annual Meeting (April 25-30, 2025).
•Preclinical combination data to be presented. In 2025, preclinical data for FHD-909 in combination with pembrolizumab and KRAS inhibitors will be presented at the AACR (Free AACR Whitepaper) Annual Meeting (April 25-30, 2025).

Ongoing strategic collaboration with Lilly. Collaborating with Lilly to create novel oncology medicines that includes a U.S. 50/50 co-development and co-commercialization agreement for Foghorn’s selective SMARCA2 oncology program, agreements for a selective inhibitor and a selective degrader, and an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control platform.

Selective CBP degrader program. Selectively targets EP300 mutated cancers, including bladder, gastric, and endometrial cancers. CBP and EP300 are highly similar acetyltransferases that create a synthetic lethal relationship when EP300 is mutated. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been limited by hematopoietic toxicity.

•Identified potent and selective CBP protein degraders. Pharmacodynamic and pharmacokinetic preclinical data demonstrate:
•Deep and sustained CBP degradation significantly inhibited tumor growth in mouse xenograft solid tumor models.
•Robust monotherapy preclinical anti-tumor activity that was not associated with significant body weight loss, thrombocytopenia, or anemia.

•Long-acting injection formulation that resulted in tumor regression from a single dose in a mouse xenograft efficacy study.

•Preclinical combination data to be presented. In 2025, preclinical data for the Selective CBP degrader program, in combination with approved chemotherapeutics and targeted agents, will be presented at the AACR (Free AACR Whitepaper) Annual Meeting (April 25-30, 2025).

Selective EP300 degrader program. Selective degradation of EP300 for the treatment of hematopoietic malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been limited by hematopoietic toxicity. EP300 lineage dependencies are established in multiple myeloma and diffuse large B cell lymphoma.

•Identified potent and selective EP300 degraders and advancing oral degrader efforts. Pharmacodynamic and pharmacokinetic preclinical data demonstrate candidates:
•Are well tolerated in vivo with no observed decrease in platelet levels, and no effects on megakaryocyte viability at pharmacologically relevant concentrations in ex vivo studies.
•Have robust anti-tumor activity in solid tumors and hematological malignancies, including prostate cancer, multiple myeloma, and diffuse large B cell lymphoma.

•Preclinical data in hematological malignancies to be presented. In 2025, preclinical data for the Selective EP300 degrader program demonstrating biological activity in hematological malignancies will be presented at the AACR (Free AACR Whitepaper) Annual Meeting (April 25-30, 2025).

Selective ARID1B degrader program. Selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including ovarian, endometrial, colorectal, and bladder. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target.

•ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.
•Developed highly potent and selective binders. Preclinical data demonstrated potent and selective small molecule binders to ARID1B.
•Selective degradation of ARID1B achieved. Foghorn has successfully selectively degraded ARID1B.
•Selective ARID1B degrader program update expected in 2025.
Chromatin biology and degrader platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in novel ligases, long-acting injectables, oral delivery and induced proximity.

Full Year 2024 Financial Highlights
•Collaboration revenues. Collaboration revenues were $22.6 million for the year ended December 31, 2024, compared to $34.2 million for the year ended December 31, 2023. The decrease year-over-year was primarily driven by revenue recognized under the Merck collaboration due to the termination of the agreement in 2023 and subsequent recognition of the remaining deferred revenue.

•Research and development expenses. Research and development expenses were $94.5 million for the year ended December 31, 2024, compared to $109.7 million for the year ended December 31, 2023. This decrease was primarily due to costs associated with decreased headcount, partially offset by an increase in spend in our Lilly collaboration programs.

•General and administrative expenses. General and administrative expenses were $28.4 million for the year ended December 31, 2024, compared to $32.4 million for the year ended December 31, 2023. This decrease was primarily due to costs associated with decreased headcount.

•Net loss. Net loss was $86.6 million for the year ended December 31, 2024, compared to a net loss of $98.4 million for the year ended December 31, 2023.

•Cash, cash equivalents and marketable securities. As of December 31, 2024, the Company had $243.7 million in cash, cash equivalents and marketable securities, providing cash runway into 2027.

About FHD-909
FHD-909 (a.k.a. LY4050784) is a highly potent, allosteric and orally available small molecule that selectively inhibits the ATPase activity of BRM (SMARCA2) over its closely related paralog BRG1 (SMARCA4), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in BRG1 rely on BRM for BAF function. FHD-909 has shown significant anti-tumor activity across multiple BRG1-mutant lung tumors.

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.