On March 6, 2025 Merck, a leading science and technology company, reported profitable growth in 2024 and delivered on its guidance for the year (Press release, Merck KGaA, MAR 6, 2025, View Source [SID1234654166]). A strong performance of Healthcare, a rebound in Life Science and profitable growth in Electronics contributed to this. During the year, Merck also strategically sharpened its portfolio’s focus on future growth areas. After a strong fourth quarter 2024, the company is looking toward 2025 with confidence and expects continued profitable growth.

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"Merck is back on a growth path with all three businesses. The challenges of recent years have been taken as an opportunity to strengthen our supply chains and invest in Europe, the United States and Asia. In 2025, we will continue to deliver profitable growth across our company. With our innovation-driven portfolio, we are ideally positioned to benefit from global macro trends such as complex biologics, novel modalities, and semiconductors for the AI era," said Belén Garijo, Chair of the Executive Board and CEO of Merck.

On March 6, 2025, Bio-Path Holdings, Inc. (the "Company") reported to have entered into a securities purchase agreement (the "Purchase Agreement") with 1800 Diagonal Lending LLC, a Virginia limited liability company (the "Lender"), an accredited investor, for the issuance and sale of a promissory note in the aggregate principal amount of $161,000 (the "Note") for a purchase price of $140,000 after deducting the original issue discount of $21,000 (Filing, Bio-Path Holdings, MAR 6, 2025, View Source [SID1234651019]). The Note bears a one-time interest charge of twelve percent that is applied on the date of issuance, March 6, 2025. The Note shall be paid in five payments with the first payment of $90,160 due on August 30, 2025 and each subsequent payment shall be equal to $22,540 which are due on September 30, 2025, October 30, 2025, November 30, 2025 and December 30, 2025.

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Upon the occurrence and during any continuation of any Event of Default (as defined in the Note), the Note shall become immediately due and payable and the Company shall pay to the Lender, in full satisfaction, an amount equal to 150% times the sum of (i) the then outstanding principal amount of the Note plus (ii) accrued and unpaid interest on the unpaid principal amount of the Note to the date of payment plus (iii) default interest, if any, at a rate of 22% per annum on the amounts referred to in clauses (i) and/or (ii) plus (iv) any amounts owed to the Lender pursuant to the Conversion Right (as defined below). In addition, only upon an Event of Default and during any continuation thereof, the Lender may elect to convert all or any part of the outstanding principal and interest on the Note in fully paid and non-assessable shares of the Company’s common stock, par value $0.001 per share ("Common Stock") at a conversion price per share equal to 65% of the lowest closing bid price of the Common Stock for the ten trading days prior to the date of conversion (the "Conversion Right"). The Lender, together with its affiliates, may not convert any portion of such Note to the extent that the Lender would own more than 4.99% of the Company’s outstanding Common Stock immediately after the conversion

The issuance of the Note and the issuance of the shares of Common Stock issuable upon any Event of Default will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws. The Note and the shares of Common Stock, if issued, will be issued in reliance on the exemptions from registration provided by Section 4(a)(2) under the Securities Act and/or Regulation D promulgated thereunder.

The Note and the Purchase Agreement contain standard and customary representations and warranties, agreements and obligations, and events of default. The foregoing descriptions of terms and conditions of the Purchase Agreement and the Note do not purport to be complete and are qualified in their entirety by the full text of the form of the Purchase Agreement and the Note, which are attached hereto as Exhibits 10.1 and 4.1, respectively.

This Current Report on Form 8-K does not constitute an offer to sell the securities or a solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.

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 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.