On March 28, 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 a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting on March 27 – 29, 2025 in Tampa, FL: ePoster P379 (Press release, Renovorx, MAR 28, 2025, View Source [SID1234651595]).

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The abstract provides new human PK data relevant to RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform. TAMP is key to the Company’s Phase III investigational drug-device combination oncology product candidate (intra-arterial gemcitabine, with RenovoCath, known as IAG) and is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapies. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

The abstract, titled "Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial," was authored by Emmanuel E. Zervos, M.D. of East Carolina University, and co-authored by Ramtin Agah, M.D., founder and Chief Medical Officer of RenovoRx and others.

"The data presented in this abstract support the potential for the TAMP therapy platform to provide a meaningful advancement in the standard of care for oncology therapy in difficult-to-treat tumors," said Dr. Zervos. "This study shows additional support for TAMP as a potential treatment option in locally advanced pancreatic cancer (LAPC). Specifically, in this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels of gemcitabine compared to intravenous gemcitabine. IAG may prove beneficial in decreasing chemotherapy-related systemic side effects. We are awaiting final outcomes in the ongoing Phase III TIGeR-PaC clinical trial for IAG to validate this benefit."

PK analyses were performed on 19 patients with locally advanced pancreatic cancer receiving IAG from six sites as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens.

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.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study 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 enabled with the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine (IAG).

On March 28, 2025 Lomond Therapeutics Holdings, Inc. ("Lomond Therapeutics"), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, reported the addition of two new investors, Yosemite Capital and QIA Investments, coincident with a second and third closing, respectively, and the raising of an additional $20 million private placement financing (Press release, Lomond Therapeutics, MAR 28, 2025, View Source [SID1234651594]).

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"We are delighted to expand the funding syndicate with the addition of these top tier investors," said Iain Dukes M.A. D.Phil., co-founder and chief executive officer at Lomond Therapeutics."

This transaction provides the additional resources necessary to advance our potentially best-in-class or first-in-class programs, lomonitinib, lonitoclax and our menin inhibitor, through clinical development. Lomonitinib is currently being evaluated in a Phase 1b clinical trial in patients with mutated FLT3 relapsed refractory AML – an area of important unmet need. Lomond enrolls CLL and selected lymphoma patients in a Phase 1b clinical trial to evaluate lonitoclax, a potentially first in class oral targeted selective B-cell lymphoma-2 ("BCL-2-2") inhibitor.

The offering was exempt from registration under Section 4(a)(2) of the United States Securities Act of 1933, as amended, and Rule 506 of Regulation D promulgated by the U.S. Securities and Exchange Commission ("SEC") thereunder. The Common Stock in the offering was sold to "accredited investors," as defined in Regulation D, and was conducted on a "reasonable best efforts" basis.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Raymond James and Wedbush & Co. acted as the placement agents.

On March 28, 2025 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported two poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper)’s European Lung Cancer Congress 2025 (ELCC 2025) (Press release, VolitionRX, MAR 28, 2025, View Source [SID1234651593]). The studies demonstrate how Volition’s Nu.Q H3K27Me3 biomarker, when combined with circulating tumor DNA, may improve the prognostic value for overall survival and could help inform treatment decisions in Non Small Cell Lung Cancer (NSCLC); and how Volition’s Nu.Q H3.1, low-cost immunoassay may be utilized for the early identification of subjects at high risk of cancer.

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ELCC 2025 is taking place in Paris, France, from March 26-29, 2025.

ELCC 2025 Poster Session Details
Poster Session and Table: #282P
Title: "Early detection of stage I/II NSCLC by immunoassay of crosslinked plasma cell fee nucleosomes"
Presenter: Jake Micallef, PhD, MBA, Volition Chief Scientific Officer
Date and Time: Friday, March 28, 2025, 1:00PM – 1:45PM (CET)

Poster Session and Table: #395P
Title: "H3K27Me3-nucleosome is a strong prognostic biomarker in non-small cell lung cancer (NSCLC): Interim results from the analysis of up to 832 patients at baseline"
Presenter: Marie Piecyk, PhD, Researcher, Center for Innovation in Cancerology of Lyon (CICLY), Hospices Civils de Lyon, Faculty of Medicine and Maieutic Lyon Sud, Claude Bernard University Lyon
Date and Time: Friday, March 28, 2025, 1:00PM – 1:45PM (CET)

The poster presentations can be viewed at
#282P
#395P

On March 28, 2025 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology , inflammatory and infectious diseases, proudly reported Dr. Tina Hieken, a surgical oncologist at Mayo Clinic and one of the principal investigators of the groundbreaking MERLIN_001 study, will present new data at the 2025 Society of Surgical Oncology (SSO) Annual Meeting (Press release, SkylineDx, MAR 28, 2025, View Source [SID1234651592]). Dr. Hieken’s presentation, titled Prospective Multicenter Evaluation (MERLIN_001 Trial) of a Clinicopathologic and Gene Expression Profile Test to Predict Sentinel Node Status in T1-T3 cN0 Melanoma, will showcase the final results of this pivotal study, which demonstrates the accuracy of the Merlin CP-GEP test in predicting sentinel lymph node (SLN) metastases in melanoma patients.

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The MERLIN_001 trial is the largest prospective, blinded study, to evaluate the Merlin CP-GEP test, which is the only commercially avialable GEP test that combines clinical, pathological, and gene expression data into a single algorithm to predict SLN positivity. The study was conducted at 9 renowned US hospitals, which are also top-ranking oncology academic centers. The study’s findings validate the test’s superior predictive accuracy compared to traditional clinical and pathological factors, which currently guide sentinel lymph node biopsy (SLNB) decisions in melanoma.

A total of 1,802 patients were included for whom SLN biopsy material was available. CP-GEP achieved an assay success rate of 97.7%, thus a total of 1,761 patients could be enrolled. The National Comprehensive Cancer Network (NCCN) clinical guidelines recommend SLNB surgery for patients with >10% risk of nodal metastases. This cohort had a 17.6% overall SLNB positivity rate, suggesting effective referral of patients based on current factors. However, 82.4% of patients had a negative sentinel node suggesting no therapeutic benefit from the sentinel node operation.

How did Merlin CP-GEP test provide more precise risk stratification, allowing physicians to further optimize SLNB referral decisions and personalize treatment plans? Key findings from the MERLIN_001 study:

In this cohort a total of 31 T1a patients with adverse features were referred for SLNB surgery. Merlin identified 80.6% as Low Risk for nodal metastases at a negative predictive value (NPV) of 100%. These patients could consider forgoing SLNB surgery as their risk of nodal metastases is close to 0%. Six patients were identified as Merlin High Risk. Their risk of metastases was with 16.7% well above the >10% guideline threshold, therefore these patients should be referred for surgery.
Among the 479 T1b patients, Merlin test identified 67.6% as Low Risk for nodal metastases with a 94.8% NPV. These patients could consider forgoing SLNB surgery as their risk of metastases is close to 5%. Additionally, T1b patients with a Merlin High Risk label had a 16.1% SLNB positivity rate and should be referred for surgery.
The study’s findings are particularly significant for T2a melanoma patients. This patient subgroup had an SLN positivity rate of 15.5%. Merlin test identified 36.6% as Low Risk at an NPV of 91.9%, reducing their metastatic risk below the 10% threshold for SLNB surgery recommendation. Reclassification of these T2a patients gives them access to more personalized treatment options.
The Merlin CP-GEP test also demonstrated exceptional performance in other subgroups, particularly in head and neck melanoma patients. SLNB surgery in this group poses unique challenges due to complex lymphatic drainage and vital anatomical structures. Merlin test identified 43.3% as Low Risk for nodal metastases with an NPV of 95.1%. These patients could consider forgoing SLNB surgery as their risk of metastases is below 5%.
"The MERLIN_001 study provides a transformative approach to melanoma risk assessment, ensuring that we can better personalize care for our patients. The test not only refines risk stratification but also addresses critical subgroups, such as head and neck melanoma patients and elderly individuals, who often face complex treatment decisions. By leveraging this groundbreaking tool, we can confidently guide SLNB recommendations and optimizing patient outcomes," said Dr. Tina Hieken.

"The MERLIN_001 study results are a breakthrough in melanoma care," said Dharminder Chahal, CEO of SkylineDx. "As the only company to have conducted this large, prospective, blinded trial of the Merlin CP-GEP test in collaboration with esteemed academic institutions in the U.S., we are committed to empowering clinicians with a rigorously validated test backed by high-quality evidence, ensuring patients receive the most informed care possible ."

The MERLIN_001 study represents a major milestone in melanoma research, with the potential to enhance clinical decision-making and improve patient outcomes. By offering more accurate risk assessments, the Merlin CP-GEP test empowers healthcare providers to tailor treatment plans to the specific needs of melanoma patients.

About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test)
CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced generation CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access.

On March 28, 2025 4SC AG (4SC, FSE Prime Standard: VSC) reported its financial results for the financial year ended 31 December 2024, presenting all material reporting period developments and providing an outlook for 2025 (Press release, 4SC, MAR 28, 2025, View Source [SID1234651591]). The full report is available at 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC continues to be one hundred percent focused on the development of resminostat and as such has now responded to the EMA’s180 Day Assessment Report within the required deadline. 4SC is now awaiting further feedback from the Committee for Medicinal Products for Human Use, which is still expected around the end of April 2025. Depending on the decision of the CHMP we will then consider what could be the future direction of the Company."

Key highlights of 2024
4SC had a very busy year in 2024, with key achievements summarized below, and further detail provided in respective press releases.

In February 2024, at an Extraordinary General Meeting the Management and Supervisory Boards fulfilled their duty to inform the shareholders of a loss amounting to half of the share capital in accordance with the rules pursuant to Section 92 (1) German Stock Corporation Act (AktG).
Also in February 2024, 4SC AG submitted its Marketing Authorisation Application (MAA) for resminostat in advanced CTCL to the European Medicines Agency (EMA) and this was accepted – by the EMA – as sufficient for examination by the beginning of March 2024.
In March 2024, 4SC entered into a second loan agreement with Santo Holding (Deutschland) GmbH (Santo Holding) giving the Company access to a further €3.5 million in available funding.
In April 2024, the company announced that the renowned dermato-oncology expert and principal investigator of the RESMAIN study, Professor Dr. Rudolf Stadler (University Hospital Johannes Wesling, Minden, Germany) presented landmark data from the pivotal RESMAN study of resminostat (Kinselby) at the 5th World Congress of Cutaneous Lymphomas (5WCCL), in Pasadena, California, USA.
Also in April 2024, 4SC received a Pediatric Investigation Plan (PIP) product-specific waiver from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for resminostat (Kinselby).
In May 2024, 4SC entered into a partnership with Vuja De Sciences, Inc., New Jersey, USA (Vuja De) – a US based biotech company focused on evaluating domatinostat in combination with Rapamycin in cancers such as recurrent metastatic osteosarcoma and refractory sarcomas.
In July 2024, 4SC announced that it had been granted Orphan Drug Status for resminostat (Kinselby) in CTCL in Switzerland.
In September 2024, 4SC completed a capital increase from authorized capital by issuing a total of 792,080 of new no-par value bearer shares, each with a notional par value of €1.00. At a subscription price of €5.05 per offered share, 4SC secured gross proceeds of circa €4.0 As a result of the transaction, 4SC’s share capital increased from €10,114,009 to €10,906,089. The new shares were subscribed for by the Company’s main shareholder, Santo Holding. Statu­tory subscription rights were excluded pursuant to Section 186 Para. 3 sentence 4 of the German Stock Corporation Act (Aktiengesetz).
Business outlook for 2025
4SC is fully focused on the registration of resminostat (Kinselby) in the key geographies of the European Union, UK and Switzerland. Subject to a final decision from the EMA, the opportunity for value creation through the commercialization of resminostat (Kinselby) in the EU remains possible, but subject to very significant risk given EMA’s 180 Day Assessment Report issued in March 2025. 4SC AG has recently responded to the EMA’s Day-180 Assessment Report within the required deadline and expects to receive feedback from the Committee for Medicinal Products for Human Use (CHMP) around the end of April 2025. Depending on the decision of the CHMP the Management Board will then consider all options for the future direction of the Company.

In the meantime, it is likely that the Company will continue to report annual net losses in the short to medium term future.

4SC continued to hold discussions with potential partners in the pharmaceutical industry regarding resminostat (Kinselby) in 2024 and early 2025, but these are currently on hold until it is clear the MAA is approvable.

For Japan, 4SC has an ongoing Collaboration Agreement with Yakult Honsha for the commercialization of resminostat (Kinselby).

Cash balance development in full year 2024 and financial forecast
4SC’s cash balance/funds were at €8,311 thousand on 31 December 2024. The average monthly operating cash burn in 2024 was €626 thousand, which was between the forecast range of €600 thousand and €900 thousand for 2024. Taking into account the current financial planning and the intended operating activities, the Management Board estimates that currently available funds should be sufficient to finance 4SC for at least the next 12 months of operations and in particular, to receive a final decision from the EMA with respect to the company’s MAA for resminostat (Kinselby).

Whilst 4SC’s funds of €8,311 thousand (at the end of 2024) represent a solid cash position, management remains cautious as to 4SC’s ability to raise additional funds through further capital measurements and or to generate income from business partners.

For 2025, 4SC is expecting an average monthly use of cash from operations of between €400 thousand and €700 thousand. 4SC estimates that the net loss will decrease significantly in 2025 as compared to 2024, due mainly to the completion of the open label component of the RESMAIN study and the filling of responses to the EMA in relation to 4SC’s MAA in late 2024.