Nuvectis Pharma, Inc. Reports 2024 Financial Results and Business Highlights

On February 25, 2025 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the year ended December 31, 2024 and provided an update on recent business progress (Press release, Nuvectis Pharma, FEB 25, 2025, View Source [SID1234650543]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "In 2024, Nuvectis made important progress in the development of our two clinical-stage drug candidates, NXP800 and NXP900. NXP800 was granted Orphan Drug Designation by the U.S. FDA for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers. Enrollment is ongoing in the Phase 1b clinical trial, in which patients with platinum resistant, ARID1a-mutated ovarian cancer are currently being treated with a dose of 75mg/day, on an intermittent dosing schedule. We intend to provide an update from this study in the second quarter and plan to provide the first data from the investigator-initiated study in cholangiocarcinoma later this year."

Mr. Bentsur continued, "For NXP900, enrollment continues in the Phase 1a dose escalation clinical trial and we are pleased with the emerging clinical profile of NXP900, based on safety, pharmacokinetics and pharmacodynamics information to date. In parallel, preparations are underway to begin the Phase 1b program in mid-year. This program is designed to evaluate NXP900 as monotherapy in YES1/SRC-driven solid tumors, and in combination with EGFR and ALK inhibitors, in patients with non-small cell lung cancer. Positive results could showcase NXP900’s potential broad applicability in these large oncology markets.

Mr. Bentsur concluded, "Our successful follow-on offering, completed this month, provided Nuvectis with $15.5M in gross proceeds, which extend our cash runway into 2027. Based on the continued progress with the NXP800 and NXP900 programs, the strength and drug development expertise of our team, and expanded cash resources, I believe Nuvectis is well-positioned to generate meaningful results in our clinical portfolio in 2025 and beyond."

Full Year 2024 Financial Results

Cash and cash equivalents were $18.5 million as of December 31, 2024, compared to $19.1 million as of December 31, 2023. The decrease of $0.6 million was a result of the Company’s continued operations, offset by access to our at-the-market offering facility.

The Company’s net loss was $19.0 million for the year ended December 31, 2024, compared to $22.3 million for the year ended December 31, 2023, a decrease in net loss of $3.3 million. Net loss for the 2024 fiscal year included $4.9 million in non-cash stock-based compensation.

Research and development expenses, including non-cash stock-based compensation were $12.9 million for the year ended December 31, 2024, compared to $15.4 million for the year ended December 31, 2023, a decrease of $2.5 million.

General and administrative expenses, including non-cash stock-based compensation were $6.9 million for the year ended December 31, 2024, compared to $7.5 million for the year ended December 31, 2023, a decrease of $0.6 million.

Interest income was $0.8 million for the year ended December 31, 2024, compared to $0.6 million for the year ended December 31, 2023, an increase of $0.2 million.

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

On February 25, 2025 Kangpu Biopharmaceuticals, Ltd. ("Kangpu") reported that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM) (Press release, Kangpu Biopharmaceuticals, FEB 25, 2025, View Source [SID1234650561]).

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KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects.

The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects.

C4 Therapeutics to Participate in Upcoming March Investor Conferences

On February 24, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that C4T management will participate in two upcoming March investor conferences (Press release, C4 Therapeutics, FEB 24, 2025, View Source [SID1234650465]).

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TD Cowen 45th Annual Healthcare Conference:
Management will present on March 3rd at 9:10 am ET in Boston, MA. The live webcast will be available on the Events & Presentations page of the company’s website. The archived replay of the webcast will be available for approximately 30 days following the live event.
Leerink Partners Global Healthcare Conference:
Management will participate in the conference on March 9th in Miami, FL.

UroGen Pharma to Present at TD Cowen 45th Annual Health Care Conference

On February 24, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference to take place on March 3-5, 2025 (Press release, UroGen Pharma, FEB 24, 2025, View Source [SID1234650482]).

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TD Cowen 45th Annual Health Care Conference

Date / Time:

March 3, 2025 at 1:50 PM ET

Format:

Presentation and 1×1 investor meetings

Location:

Boston, MA

Webcast Link:

here

Webcasts from the conferences will also be available on UroGen’s Investor Relations website. A replay will be available on the site for approximately 90 days.

LTZ Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of First-in-Class Myeloid Engager Immunotherapy, LTZ-301

On February 24, 2025 LTZ Therapeutics, an immunotherapy-focused biotech company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma (r/r NHL) (Press release, LTZ Therapeutics, FEB 24, 2025, View Source [SID1234650498]).

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LTZ-301 is the first asset in the company’s platform to enter clinical trials to determine an initial proof of concept for their myeloid engager approach, to foster immunotherapy. LTZ expects to initiate its Phase 1, open-label, multicenter study in Q2 2025.

"The FDA’s clearance, signaling the initiation of our Phase I study for LTZ-301, represents a significant milestone for the company," said Robert Li, Ph.D., Founder and CEO of LTZ. "We look forward to advancing our lead asset into the clinic to evaluate our myeloid engager approach and its potential as an effective therapy for cancer and other indications, such as autoimmune diseases. Additionally, the recent appointment in October 2024 of Dr. Wayne Godfrey, as LTZ’s Chief Medical Officer, strengthens our company’s scientific and clinical leadership – providing us with great optimism as we move forward in our next phase of clinical development. We’re also delighted to welcome Dr. Alan J. Korman, a globally recognized pioneer in cancer immunology, to LTZ’s scientific advisory board."

LTZ’s approach focuses on the fusion of reverse translational science, with a deep understanding of tumor microenvironment (TME) biology – especially myeloid biology. Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells offers significant therapeutic potential for patients. LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages of different polarization states to foster anti-tumor immunity.

"The company’s preclinical results have demonstrated promising activity and safety, suggesting applicability of LTZ’s platform to treat a variety of cancer indications and autoimmune diseases – where the unmet need is incredibly high," said Dr. Godfrey. "Through our first in-human trial, we aim to advance our understanding of the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LTZ-301, targeting CD79b-expressing B-cell lymphoma. I’m excited about the potential of LTZ’s innovative scientific approach and the opportunity to work with LTZ’s accomplished scientific team, with the end goal of improving patient outcomes."

About LTZ-301

LTZ-301 is a novel myeloid engager bi-specific antibody that depletes CD79b+ B-cells via enhancing Fc-gamma receptor (FcγR)-independent antibody dependent cellular phagocytosis (ADCP). CD79b is a unique tumor antigen receptor that is highly expressed in B-cell malignancies, including the ones of relapse/resistance to the existing CD19 or CD20-based therapies. LTZ-301 works by redirecting monocytes and macrophages toward CD79b+ B-cells, leading to enhanced phagocytosis and depletion of cancer cells. The initial study of LTZ-301 will be conducted in patients with r/r NHL for whom no standard therapy is available or where standard treatment has failed. Preclinical studies of LTZ-301 demonstrated potent pharmacology in both in vitro and in vivo studies with a favorable safety profile.