On March 6, 2025 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported the first patient has been dosed in the company’s Phase 1/2 clinical trial of its hypoxia reversal agent IMGS-101 (evofosfamide) in combination with Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) at The University of Texas MD Anderson Cancer Center in Houston, Texas (Press release, ImmunoGenesis, MAR 6, 2025, View Source;head–neck-t-302393719.html [SID1234650989]). Tumor hypoxia (low oxygen levels) is an immunosuppressive factor in solid tumors. By reversing hypoxia, IMGS-101 may improve the efficacy of immunotherapies in cancer types that are otherwise resistant to immune-based treatments.

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The Phase 1/2, open-label, multicenter study (NCT06782555) consists of a dose escalation and expansion portion to evaluate the safety, pharmacokinetics, and anti-tumor activity of IMGS-101 in combination with Balstilimab and Zalifrelimab in adult patients with locally advanced or metastatic castration-resistant prostate cancer (CRPC), pancreatic cancer, and human papillomavirus-(HPV) negative squamous cell carcinoma of the head and neck (SCCHN). The study is being conducted in collaboration with Agenus, a clinical-stage immuno-oncology company developing the checkpoint inhibitors Balstilimab and Zalifrelimab.

"Launching this trial represents a significant milestone in our mission to target key mechanisms of immune resistance," said ImmunoGenesis President and CEO James Barlow. "By targeting and reversing hypoxia, we aim to unlock the immune system’s full potential and redefine the therapeutic landscape for these cancers with high unmet medical needs."

"This trial marks an exciting step forward in addressing one of the key challenges in cancer immunotherapy," said Dr. Charles Schweizer, Senior Vice President of Clinical Development at ImmunoGenesis. "Hypoxia limits T-cell infiltration and suppresses immune responses, especially in prostate, pancreatic, and head and neck cancers. By reversing hypoxia, IMGS-101 may restore T-cell access to tumors, enhancing the effectiveness of checkpoint inhibitors and potentially transforming outcomes in these hard-to-treat cancers."

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 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2024 (Press release, Delcath Systems, MAR 6, 2025, View Source [SID1234650953]).

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Fourth Quarter and Full Year 2024 Financial Results

Total fourth quarter and full year revenue of $15.1 million and $37.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue of $13.7 million and $32.3 million, respectively
CHEMOSAT fourth quarter and full year revenue of $1.4 million and $4.9 million, respectively
Gross margins of 86% for the fourth quarter and 83% for the full year
Fourth quarter and full year net loss of $3.4 million and $26.4 million, respectively
Non-GAAP positive adjusted EBITDA for the fourth quarter of $4.6 million and full year adjusted EBITDA loss of $2.5 million
During the year, the exercise of warrants generated approximately $41.3 million in funding, resulting in year-end cash and investment balance of $53.2 million. The company’s fourth quarter operating cash burn was $1.0 million
As of December 31, 2024, there are no outstanding debt obligations
Business Highlights and Updates

Activated 4 U.S. centers in the fourth quarter and 2 more so far in the first quarter of 2025, bringing the current total to 16 active centers, with 8 additional centers currently accepting referrals
Received FDA Clearance of an IND Application for a Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Colorectal Cancer
Appointed Michael Brunner, M.D., as the Senior Vice President of Interventional Oncology to further Delcath’s research and development efforts. Dr. Brunner is the former President of the Society of Interventional Radiology with over 25 years of experience in academia and biotech leadership
The National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for metastatic uveal melanoma (mUM) treatment to include HEPZATO KIT as an option for patients with hepatic-dominant uveal melanoma, expanding from the previous guidance that limited its use to those with liver-confined metastases
"In 2024, the successful launch of HEPZATO drove strong financial and operational results, including positive adjusted EBITDA in the fourth quarter," said Gerard Michel, Delcath’s Chief Executive Officer. "As HEPZATO becomes more established as a leading treatment option for metastatic uveal melanoma, we’re seeing growing adoption across treatment centers and meaningful revenue growth. This momentum enables us to advance R&D programs targeting other liver-dominant cancers, including metastatic colorectal and breast cancer."

Fourth Quarter and Full Year 2024 Results

Total revenue for the quarter ended December 31, 2024 was $15.1 million compared to $0.5 million for the same period in the prior year. Revenue in the quarter includes sales of $13.7 million of HEPZATO in the U.S. and $1.4 million of CHEMOSAT in Europe.

Total revenue for the year-ended December 31, 2024 was $37.2 million compared to $2.1 million for the same period in the prior year. Revenue in 2024 includes sales of $32.3 million of HEPZATO in the U.S. and $4.9 million of CHEMOSAT in Europe.

Research and development expenses for the quarter and year-ended December 31, 2024, were $2.9 million and $13.9 million, respectively compared to $4.7 million and $17.5 million for the same periods in the prior year. The decrease is primarily due to lower costs associated with the NDA submission and expanded access program costs offset by an increase in medical affairs and regulatory costs associated with an approved product.

Selling, general and administrative expenses for the quarter and year-ended December 31, 2024, were $7.0 million and $29.6 million, respectively compared to $7.0 million and $22.1 million for the same periods in the prior year. The increase is primarily due to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

Net loss for the quarter and year-ended December 31, 2024 was $3.4 million and $26.4 million, respectively compared to net loss of $11.1 million and $47.7 million for the same periods in the prior year.

Non-GAAP adjusted EBITDA for the quarter and year-ended December 31, 2024 was $4.6 million and loss of $2.5 million, respectively, compared to adjusted EBITDA loss of $9.3 million and $30.0 million for the same periods in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of December 31, 2024, the Company had $53.2 million in cash and investments, and no debt.

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Event Date: Thursday, March 6, 2025
Time: 8:30 AM Eastern Time

On March 6, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported it is proceeding with a Phase 1 clinical trial evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas, based on a recent Clinical Trial Application (CTA) cleared by Health Canada (Press release, Bantam Pharmaceutical, MAR 6, 2025, View Source [SID1234650990]). This regulatory milestone enables Bantam to expand its ongoing clinical program and to activate multiple clinical trial sites in Canada early in the second quarter of 2025.

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This clearance follows the recent activation of Bantam’s first U.S. clinical trial site at The University of Texas MD Anderson Cancer Center for its BTM-3566 Phase 1 study. BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway to treat aggressive tumors.

"Activating clinical sites in Canada alongside our U.S. study sites is a key step in building a high-quality, efficient, and thoughtful clinical program," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "This complementary approach accelerates the identification of clinically active doses for lymphoma patients while maintaining the scientific rigor needed to ensure a meaningful impact for those in need. We anticipate this expansion to enable us to achieve our clinical objectives sooner than originally projected."

The Phase 1 trial is designed to evaluate the safety, tolerability, and preliminary efficacy of BTM-3566 in patients with relapsed/refractory mature B-cell lymphomas. The Canadian trial will follow a similar overall design to the ongoing U.S. Phase 1 trial, a multicenter, open-label, and dose-escalation study assessing the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of BTM-3566. The dual country strategy was implemented to accelerate the development of BTM-3566 and will support future harmonization between the studies to generate a robust dataset and inform future development. Initial clinical data from the trial are expected in the second half of 2025.

For more information about the ongoing clinical trial, visit ClinicalTrials.gov and search NCT number NCT06792734.

About BTM-3566

BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options.

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.