Cyclacel Pharmaceuticals Reports FIRST quarter financial results and provides business update

On May 14, 2025 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, reported its first quarter financial results and provided a business update (Press release, Cyclacel, MAY 14, 2025, View Source [SID1234653165]).

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"As part of the Company’s efforts to reduce operating costs it has determined to focus on the development of the plogosertib ("plogo") clinical program only. Accordingly, on March 10, 2025, the Company repurchased certain assets related to plogo from Cyclacel Limited for approximately $0.3 million in cash, to allow us to continue our efforts on developing an alternative salt, oral formulation of plogosertib with improved bioavailability," said Datuk Dr. Doris Wong, Chief Executive Officer. "Cyclacel Limited’s other drug development program, fadraciclib, is being marketed for sale by that entity’s liquidator in the U.K. pursuant to creditors voluntary liquidation of Cyclacel Limited announced in the London Gazette on January 31, 2025."

"Upon the commencement of the liquidation of Cyclacel Limited, the Company lost operational and strategic control over Cyclacel Limited and thus its financial results have been deconsolidated from the Company effective January 31, 2025; as a result, the Company anticipates a significant decrease to research and development expenses for the year ended December 31, 2025 as we focus on plogo and have no further expenditures related to fadraciclib," said Kiu Cu Seng, Chief Financial Officer. "The deconsolidated of our former subsidiary, Cyclacel Limited, resulted in a gain on deconsolidation, and thus an increase in stockholders’ equity of approximately $5.0 million, which we have reported in the Company’s Form 10-Q for the three months ended March 31, 2025."

Due to the current difficult economic environment and our lack of funding to implement our business plan, we have begun to analyze strategic alternatives available to the Company to continue as a going concern. Such alternatives include raising additional debt or equity financing or consummating a merger or acquisition with a partner that may involve a change in our business plan. As a result, the Company entered into an Exchange Agreement with FITTERS Diversified Berhad on April 6, 2205, to exchange all of the ordinary shares owned by FITTERS in exchange for approximately 19.99% of the Company’s common stock to acquire FITTERS’ wholly-owned subsidiary, Fitters Sdn. Bhd., a Malaysia-based private limited company specializing in supplying, and trading various protective and fire safety equipment.

Financial Highlights

As of March 31, 2025, cash and cash equivalents totaled $3.5 million, compared to $3.2 million as of December 31, 2024.

Net cash used in operating activities was $3.3 million for the three months ended March 31, 2025,. The Company estimates that its current cash resources will fund planned programs into the second quarter of 2025.

Research and development expenses were $0.8 million for the three months ended March 31, 2025, as compared to $2.8 million for the same period in 2024. Expenditure for the transcriptional regulation program ceased as a result of the Company’s UK subsidiary, Cyclacel Limited, being liquidated on January 24, 2025. Research and development expenses relating to plogosertib decreased by $0.6 million relative to the respective comparative period whilst we continue to explore and develop an alternative salt, oral formulation with improved bioavailability.

General and administrative expenses increased by approximately $2.6 million from $1.6 million for the three months ended March 31, 2024 to $4.2 million for the three months ended March 31, 2025, due to several one-time costs associated with the change of control of the Company; primarily stock compensation expense of $1.4 million, D&O insurance costs of $0.7 million, compensation expense of $0.3 million and legal costs of $0.1 million.

Total other (expense) income, net, for the three months and year ended March 31, 2025, were $5.0 million, compared to $0.1 million for the same period of the previous year, primarily due to a $5.0 million gain on deconsolidation of the UK subsidiary.

United Kingdom research & development tax credits for the three months ended March 31, 2024, were $1.4 million. There were no research and development tax credits for the three months ended March 31, 2025, following the liquidation of the UK subsidiary and the subsequent loss of eligibility for recoverable tax credits as a result thereof.

Net loss for the three months ended March 31, 2025, was $0.1 million (including stock-based compensation expense of $1.6 million), compared to $2.9 million (including stock-based compensation expense of $0.2 million) for the same period in 2024.

RenovoRx to Participate in Fireside Chat at A.G.P. Virtual Healthcare Company Showcase on May 21st

On May 14, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath©, a novel, FDA-cleared drug-delivery device, reported that Chief Executive Officer, Shaun Bagai, will participate in a fireside chat at the Alliance Global Partners (A.G.P.) Virtual Healthcare Company Showcase hosted by Scott Henry, Managing Director and Healthcare Analyst at A.G.P., on May 21, 2025 (Press release, Renovorx, MAY 14, 2025, View Source [SID1234653103]).

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Mr. Bagai will share recent business developments, highlighting continuing momentum with the Company’s RenovoCath commercialization, as well as progress in the ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG) for treatment in locally advanced pancreatic cancer (LAPC), which is currently under investigation, and has not yet been approved for commercial sale.

Fireside Chat Details:
Date: Wednesday, May 21, 2025
Time: 12:40 p.m. ET
Speaker: Shaun Bagai, CEO
Moderator: Scott Henry, AGP Managing Director and Healthcare Analyst
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact your A.G.P. representative or KCSA Strategic Communications at [email protected].

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform is enabled with the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy (intra-arterial gemcitabine, known as IAG).

Qihan Biotech Presented its Breakthrough CAR-T Research at ASGCT 2025

On May 14, 2025 Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, reported new advancements in its universal CAR-T cell therapy research, to be presented at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Qihan Biotech, MAY 14, 2025, View Source [SID1234653102]).

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Through systematic exploration of T cell cytokine pathways, Qihan Biotech identified two novel cytokines that significantly enhance CAR-T cell activity. By engineering the corresponding receptor pathways, the company achieved robust CAR-T expansion in non-human primate models without lymphodepletion preconditioning and observable toxicity. This breakthrough offers a promising strategy to optimize CAR-T therapies and enables safer application in autoimmune diseases, paving the way for broader clinical use of CAR-T therapies.

Dr. Luhan Yang, Founder and CEO of Qihan Biotech, stated: "This research marks a significant step forward in CAR-T therapies. Enhancing CAR-T efficacy without lymphodepletion and toxicity could unlock its full potential in treating autoimmune diseases. We plan to begin clinical studies in 2025."

Poster Presentation Details:

Poster #1761: Enhanced CAR-T cell functions without lymphodepletion via engineering cytokine pathways

Session: Poster Abstract Session

Session Dates: May 13–15, 2025

Tempus Enters Multi-Year Strategic Collaboration With Boehringer Ingelheim to Advance Its Cancer Pipeline

On May 14, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a new strategic collaboration to advance Boehringer Ingelheim’s growing cancer pipeline (Press release, Tempus, MAY 14, 2025, View Source [SID1234653101]). The new, multi-year collaboration builds on foundational work the two companies have conducted in the last few years, leveraging data and AI to further advance therapeutic research and development.

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Despite significant breakthroughs in the understanding, prevention, and treatment of cancer, the disease remains a major challenge, impacting millions of lives and straining healthcare systems. Boehringer Ingelheim is committed to changing this by advancing the discovery and development of new breakthrough treatments for people living with hard-to-treat cancers. With this new collaboration, Boehringer will have access to Tempus’ de-identified database containing molecular, clinical, and imaging data and its analytical platform, Lens. The aim is to explore data derived from patient cohorts to guide biomarker development and patient stratification, develop drug combination hypotheses, support novel target discovery efforts, and educate on patients’ healthcare journey.

"By combining internal, pre-clinical experimental data, with real-world data from Tempus on its AI-powered platform, we can profoundly deepen our understanding of cancer biology and accelerate our drug discovery and development efforts," said Mark Paul Petronczki, Head of Oncology Research at Boehringer Ingelheim.

"Leveraging real-world patient data is crucial for strengthening our data foundation and harnessing advanced AI methodologies, ultimately accelerating drug development. Integrating these comprehensive datasets with our internal data and techniques not only drives innovation but also enhances the precision and efficiency of pharmaceutical research, paving the way for groundbreaking medical advancements. I am very excited to continue our collaboration with Tempus," stated Jan Nygaard Jensen, Head of Computational Innovation at Boehringer Ingelheim.

"We look forward to expanding our work with the Boehringer team and the opportunity to deploy multiple of our solutions to their growing oncology pipeline," said Ryan Fukushima, Chief Operating Officer at Tempus. "We both are firmly committed to applying the power of data and AI to this important research to bring novel treatments to patients faster."

Schrödinger to Present Phase 1 Clinical Data on MALT1 Inhibitor SGR-1505 at EHA Annual Congress and International Conference on Malignant Lymphoma

On May 14, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported that initial Phase 1 clinical data for SGR-1505, its investigational MALT1 inhibitor, will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, taking place June 12 – 15, 2025, in Milan, Italy (Press release, Schrodinger, MAY 14, 2025, View Source [SID1234653100]). Additional data from this trial will be presented at the International Conference on Malignant Lymphoma, taking place June 17 – 21, 2025, in Lugano, Switzerland.

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The Phase 1 study is designed to evaluate the safety, tolerability and anti-tumor activity of SGR-1505 in patients with relapsed/refractory B-cell malignancies. The poster presentations will include initial safety, pharmacokinetic and pharmacodynamic data, as well as preliminary efficacy data across a range of dosing levels, schedules and B cell malignancies. The data support the continued development of SGR-1505 in this patient population.

The abstract for the presentation at EHA (Free EHA Whitepaper) will be available online at www.ehaweb.org. Details of the data presentations are as follows:

European Hematology Association Annual Congress (EHA) (Free EHA Whitepaper)
Abstract Number: #PS1569
Poster Title: A Phase 1 study of SGR-1505, an oral, potent, MALT1 inhibitor for relapsed/refractory (R/R) B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL)
Presentation Date and Time: Saturday, June 14, 2025, 6:30-7:30PM CST (12:30-1:30PM ET)
Location: Poster Session 2

International Conference on Malignant Lymphoma (ICML)
Abstract Number: #444
Poster Title: A Phase 1 study of SGR-1505, an oral, potent MALT1 inhibitor for R/R B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
Presentation Date and Time: Friday, June 20, 2025, 12:30-13:00PM CST (6:30-7:00AM ET)
Location: Marquee Parco Ciani

Webcast and Conference Call Information
Schrödinger will host a conference call to review and discuss the SGR-1505 Phase 1 data presented at EHA (Free EHA Whitepaper) on Thursday, June 12, 2025, at 8:00 a.m. ET. The live webcast can be accessed under "Events & Presentations" in the investors section of Schrödinger’s website, View Source To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.