On March 3, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard) (Press release, Nuvation Bio, MAR 3, 2025, View Source [SID1234650860]). The transaction comprises a royalty interest financing of $150 million and a senior term loan of up to $100 million. These financings strengthen Nuvation Bio’s balance sheet to fully fund commercialization of taletrectinib in the U.S., if approved, and development of the Company’s current clinical-stage pipeline. The transaction also provides Nuvation Bio with a path to potential profitability without the need to raise additional capital.

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"This transaction is a significant milestone for Nuvation Bio as we prepare to bring taletrectinib to the U.S. market, subject to FDA approval, in mid-2025," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "With these financings, we are well positioned to launch taletrectinib and drive continued development of our clinical-stage pipeline—all without the need for additional fundraising. This also improves our flexibility to pursue strategic opportunities to deploy our capital. We are thrilled to have support from Sagard and appreciate their shared confidence in taletrectinib and Nuvation Bio as we continue toward our goal of improving outcomes for patients with cancer."

Subject to the approval of taletrectinib by the U.S. Food and Drug Administration (FDA) on or prior to September 30, 2025, Sagard will provide Nuvation Bio with an upfront cash payment of $150 million. In return, Sagard will receive tiered royalties on U.S. net sales of taletrectinib, including 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. Nuvation Bio will retain all annual U.S. net sales above $1 billion. Payments to Sagard will cease upon the earliest occurrence of total royalties reaching 1.6 times its investment by June 30, 2031, 1.75 times its investment by June 30, 2034, or 2.0 times its investment thereafter.

"We are excited to partner with Nuvation Bio, an organization with deep oncology expertise and a commitment to delivering transformative therapies," said Raja Manchanda, Partner at Sagard Healthcare Partners. "We believe taletrectinib has the potential to redefine the treatment landscape for patients with ROS1-positive non-small cell lung cancer, and we are pleased to provide a structured financing that supports both potential near-term commercialization and long-term growth."

In addition to the royalty financing, Sagard has committed to a 5-year, senior secured term loan of up to $100 million, with $50 million to be funded upon U.S. FDA approval of taletrectinib on or prior to September 30, 2025. The second tranche of $50 million is available at Nuvation Bio’s option until June 30, 2026, as long as Nuvation Bio has achieved first U.S. commercial sale of taletrectinib. The term loan will bear interest at SOFR + 6.00%, subject to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, with all outstanding principal due at maturity.

TD Cowen served as financial advisor and Cooley LLP served as legal advisor to Nuvation Bio. Sidley Austin LLP served as legal advisors to Sagard.

On March 3, 2025 Be Biopharma, Inc. ("Be Bio"), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), reported the appointment of Susan Abu-Absi, Ph.D., as Chief Operating Officer (Press release, Be Biopharma, MAR 3, 2025, View Source [SID1234650825]). With over 20 years of experience in strategic operations, product development and manufacturing in the biotechnology industry, Dr. Abu-Absi brings a wealth of knowledge and expertise to the role, positioning Be Bio for continued growth and operational excellence.

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Dr. Abu-Absi’s career has been marked by her leadership in the development and manufacturing of biologics and cell and gene therapies, contributing to the approval of several key products, including Abecma, Zynteglo, Skysona, Yervoy and Opdivo. Dr. Abu-Absi most recently served as Chief Technology Officer at 2seventy bio, where she built the global manufacturing and supply infrastructure and managed strategic partnerships with academics, partner innovator companies and suppliers to enable the translation of four novel cell therapies into the clinic. Prior to that, she held leadership roles in technical and product development at bluebird bio, Bristol Myers Squibb and Bayer Healthcare. Dr. Abu-Absi holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering from the University of Toledo.

"Susan is an outstanding leader and accomplished executive whose experience will further strengthen our leadership team as we solidify our position as a multi-program, clinical-stage company," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer. "She joins Be Bio at an ideal time, with enrollment now underway in the BeCoMe-9 trial for BE-101 in Hemophilia B, and with our development candidate, BE-102, progressing toward IND as a potential breakthrough for patients with Hypophosphatasia. We look forward to leveraging Susan’s expertise as we pioneer our B Cell Medicines to potentially transform the treatment landscape for a wide range of diseases."

In conjunction with the appointment of Dr. Abu-Absi, Be Bio announced the departure of President & Chief Operating Officer Krishnan Viswanadhan, Pharm.D., who is leaving Be Bio to pursue another leadership position in the biotechnology industry.

"I would like to thank Krishnan for his invaluable contributions to Be Bio, especially his leadership in advancing our lead program, BE-101, to the clinic as a potentially game-changing therapy for people with Hemophilia B," continued Dr. Smith-Farrell. "His dedication and impact have helped shape who we are today, and we are deeply grateful for his time with us. We wish him all the best in his next chapter."

About Engineered B Cell Medicines – A New Class of Cellular Medicines
The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

On March 3, 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 its abstract has been accepted for poster presentation at the Acute Leukemias XIX (ISALXIX) International Symposium being held March 16-19, 2025 in Munich, Germany (Press release, Moleculin, MAR 3, 2025, View Source [SID1234650844]).

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Details for the poster presentation are as follows:

Abstract: P002
Session: Clinical Studies in AML and ALL
Title: Liposomal Annamycin in Combination with Cytarabine for Treatment of Acute Myeloid Leukemia (AML)
Presenting Author: Cristina Papayannidis, MD, PhD, Adjunct professor, Department of Medical and Surgical Sciences, University of Bologna, Bologna Italy

For more information about the ISALXIX International Symposium, visit the event website.

On March 3, 2025 Laekna (2105.HK) reported that the U.S. Food and Drug Administration (FDA) has approved the IND for LAE120, an internally discovered USP1 inhibitor, for the treatment of advanced solid tumors (Press release, Laekna Therapeutics, MAR 3, 2025, View Source [SID1234650861]).

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LAE120 is a novel, allosteric and highly potent USP1 inhibitor, displaying monotherapy potency and combination activity with PARP inhibitor in HRD (homologous recombination deficiency) cancers. It has a unique chemical structure differentiated from all the other disclosed USP1 inhibitors and is expected to induce a different conformational change in USP1. LAE120 shows robust tumor inhibitory activity across various xenograft models such as MDA-MB-436 and K562 as a single agent and exhibits synergistic effect in combination with PARP inhibitors. It also demonstrates good therapeutic windows in GLP long-term toxicology study. Laekna is actively exploring partnerships to accelerate the clinical development of LAE120.

"Leveraging our deep know-how and extensive expertise in drug discovery, Laekna has developed a distinctive portfolio of innovative drug candidates through the close collaboration of our Med Chem, Biology and AIDD (AI-driven Drug Discovery) teams, continuously advancing preclinical drug candidates into clinical stage. Laekna has also significantly accelerated the progress of drug discovery by utilizing cutting-edge artificial intelligence tools," said Dr. Justin Gu, Chief Scientific Officer of Laekna. "We look forward to bringing novel drugs to patients as swiftly as possible," he added.

Advancing Diversified Pipelines

Laekna is actively advancing preclinical drug candidates. In the fourth quarter of 2024, another internally discovered anti-tumor drug candidate, LAE118, a potentially best-in-class, mutant-selective PI3Kαinhibitor, has advanced to IND-enabling study. PI3Kα mutations are prevalent in patients with breast, colorectal, lung, endometrial, and numerous other cancers. However, the first-generation drugs targeting PI3Kα inhibit the wild-type and mutant PI3Kα with equal potency, which raises concerns of tolerability and therapeutic efficacy.

As a novel allosteric inhibitor, LAE118 demonstrates excellent potency and selectivity towards various PI3Kα mutants. With superior anti-cancer efficacy and tolerability than other current PI3Kα inhibitors, LAE118 is potentially the best-in-class pan-mutant-selective PI3Kα inhibitor. Laekna has presented the preclinical characterization of LAE118 at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. LAE118 is in IND-enabling studies and IND is expected to be filed in the fourth quarter of 2025.

Strategic Partnerships to Accelerate Globalization

"We will continue to advance and expand our product portfolio in the therapeutic areas where we have accumulated tremendous experience and extensive know-how," said Dr. Chris Lu, Chief Executive Officer of Laekna. "In November 2024, the Group has entered into a clinical collaboration agreement with Lilly (NYSE:LLY) to support and accelerate global clinical development of LAE102 for the treatment of obesity. We plan to pursue strategic partnerships with global leading pharmaceutical companies to accelerate clinical development and commercialization of our drug candidate assets. We keep advancing and expanding our pipeline and are committed to bringing life-changing medicines to more people around the world," he added.

On March 3, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that the European Society of Medicine Journal published an innovative article titled: "The Neuro- Cardio- and Hepato- Protective Effects of Namodenoson are Mediated by Adiponectin" (Press release, Can-Fite BioPharma, MAR 3, 2025, View Source [SID1234650826]). The study is the result of a collaboration between Can-Fite scientists and leading hepatologists from the Department of Gastroenterology and Liver Diseases at Soroka University Medical Center, Beer Sheva, Israel.

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The article presents compelling preclinical and clinical data demonstrating Namodenoson’s potent anti-ischemic, anti-inflammatory, anti-fibrotic, and anti-toxicity effects across multiple body tissues including the liver, central nervous system, and cardiovascular system. The study highlights Namodenoson’s ability to increase adiponectin levels, a key cytokine known to drive multi-organ protective effects. Importantly, the manuscript underscores Namodenoson’s dual role as both an anti-cancer therapy and a protective agent for normal tissues, setting it apart from conventional chemotherapy and other oncology treatments with significant toxicity.

Dr. Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: "The data published in this journal further supports Namodenoson’s unique profile as an anti-cancer drug that simultaneously safeguards healthy body systems. This critical distinction positions Namodenoson as a potential breakthrough therapy, unlike traditional chemotherapy, which is often associated with severe toxicity.

Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug has an Orphan Drug status with both FDA and EMA and a Fast Track status with the FDA.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.