On March 18, 2025 Enzo Biochem, Inc. (NYSE: ENZ) ("Enzo" or the "Company") reported financial results for the fiscal second quarter ended January 31, 2025, with sequential quarter improvement in revenue, gross margin and operating profit / loss (Press release, Enzo Biochem, MAR 18, 2025, View Source [SID1234651217]).

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Financial Highlights

● The Company’s second-quarter gross margin percentage of 52% increased sequentially from 37% during Q1 2025 and increased from 49% during the second quarter of the prior year. These improvements were driven by change in revenues, cost efficiency actions completed, and mix of products sold.

● The Enzo Life Sciences Products segment, which excludes discontinued operations and Corporate overhead, achieved a $0.5 million operating profit during Q2 FY25, a $2M sequential improvement compared to a $1.5 operating loss during Q1 FY25, and a $0.2 million improvement compared to the second quarter of the prior year. These improvements were driven by change in revenues, cost efficiency actions completed, and mix of products sold.

● The operating loss results for the first half of FY25 for the Company’s continuing operations improved by $2.4 million. Through cost containment, the company reduced cost of revenues by 14%. In addition, spend in SG&A and R&D decreased by 22% and 27%, respectively. Product launches continue, despite the reduction in R&D.

● The Company’s second-quarter revenue of $7.3 million increased sequentially by $1.1 million from $6.2 million. This is an improvement of 18%. Year-over-year quarterly period revenue declined by 14% primarily from the timing of large order fulfillment and the market slowdown in the US.

● Enzo ended the second quarter with aggregate cash and cash equivalents of $40.3 million. The Board of Directors and management continue to be focused on conserving cash.

● Product Life Cycle maintenance continues with an increasing number of SKU launches. Enzo increased product launches to bolster the base business within the first half of the fiscal year, doubling the count of new products compared to the prior full year.

Recent Events

● As previously disclosed, the Company and plaintiffs have reached a class-wide settlement agreement pertaining to the April 2023 cyber incident and filed an unopposed motion for preliminary approval with the Court. The Court granted the motion and set a final fairness hearing on June 10, 2025. The settlement value of $7.5 million had been accrued for in our prior year financial statements and an initial payment was made subsequent to January 31, 2025 in an amount of $0.8 million.

● We continue to explore all strategic alternatives to maximize value for the Company’s stockholders, including without limitation, improving the market position and profitability of our services in the marketplace, and enhancing our valuation. We may pursue our goals through organic growth and strategic initiatives. Additionally, we will continue to review information regarding potential acquisitions or joint ventures, and provide information to third parties regarding potential dispositions of assets or business lines, including a potential sale of the Company, from time to time.

● The Company submitted a plan on February 21, 2025 to cure the market capitalization, stockholder’s equity and average closing stock price deficiencies and to return to compliance with the NYSE’s continued listing standards. The plan considers all available alternatives to cure the deficiencies identified by the NYSE, which plan is being reviewed by the NYSE. The Common Stock continues to be listed and trade on the NYSE, subject to the Company’s ongoing compliance with the NYSE’s other continued listing standards and the acceptance by the NYSE of this plan.

On March 18, 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 it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson (Press release, Can-Fite BioPharma, MAR 18, 2025, View Source [SID1234651216]).

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Compassionate use is the term used when a physician is requesting for a single patient to gain access to an investigational drug for a serious disease. Such investigational drug has not yet been approved by the FDA.

Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: "We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase 2a clinical trial, as we remain committed to advancing the availability of our drug."

Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the FDA and the European Medicines Agency (EMA). The drug is currently being tested in Israel in a Phase IIa pancreatic cancer clinical study.

Namodenoson, has been also granted Orphan Drug Designation by the FDA for pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages.

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.

On March 17, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of a best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) (Press release, Cel-Sci, MAR 17, 2025, View Source [SID1234651204]). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $2,560,000. The offering is expected to close on March 18, 2025, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these 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 17, 2025 CEL-SCI Corporation (NYSE American: CVM) reported it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study’s Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer (Press release, Cel-Sci, MAR 17, 2025, https://www.businesswire.com/news/home/20250316883464/en/CEL-SCIs-Head-and-Neck-Cancer-Registration-Study-Protocol-Clears-FDA-Reviewin-Talks-with-Potential-Partners-Interested-in-Commercialization-of-Multikine [SID1234651203]). The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024.

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CEL-SCI’s 73,000 square foot Multikine manufacturing facility presently has the capacity to produce over 12,000 Multikine treatments per year. Over $200 million has been invested in the facility and the development and validation of its proprietary biologic manufacturing processes.

"Given Multikine’s excellent survival data, strong statistics and the recent focus on PD-L1 as a diagnostic biomarker for predicting the most effective treatment strategy for head and neck cancer, we are pursuing discussions with key parties to help CEL-SCI complete the last study needed in order to pursue marketing approval for Multikine," stated CEL-SCI CEO Geert Kersten.

"These discussions may lead to potential partnerships involving non-dilutive funding for the 212-patient confirmatory Registration Study designed to bring Multikine to market. We are seeing new interest from highly placed individuals and commercial entities that recognize that Multikine, based on its different mechanism of action, is uniquely positioned to treat about 70% of head and neck cancer patients who have low PD-L1 tumor expression, an area where commercially available PD-L1 inhibitors such as nivolumab and pembrolizumab cannot help. These data, combined with our dedicated Multikine manufacturing facility, position Multikine as a very attractive oncology asset," Kersten concluded.

CEL-SCI completed a randomized controlled Phase 3 study conducted in 928 locally advanced, resectable head and neck cancer stage 3 and 4a patients in 23 countries on 3 continents. The Phase 3 study demonstrated strong statistical results and improved survival with Multikine neoadjuvant treatment over control. The 5-year survival rate of the target patient population that will be treated in the confirmatory Registration Study increased to 73% when patients were treated with Multikine before standard of care vs 45% for control patients who received only the standard of care treatments. The survival advantage over control was accentuated in patients who had low to zero expression of PD-L1 on their tumors and had lower disease burden by having N0 (no nodal involvement).

On March 17, 2025 Egle Therapeutics, a clinical-stage biotechnology company developing therapies targeting regulatory T cells (Tregs) for immuno-oncology and autoimmune diseases, reported that it has secured €9.3 million in state funding under the "Innovations in Biotherapies and Bioproduction" call for projects from the France 2030 plan, managed on behalf of the French government by Bpifrance (Press release, Egle Therapeutics, MAR 17, 2025, View Source [SID1234651202]).

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Founded in 2020 as a spin-off from Institut Curie, Egle Therapeutics is a clinical-stage biotechnology company specializing in immunomodulation, with the ambition to develop novel approaches to the modulation of Treg activity for the treatment of cancer and autoimmune diseases.

Egle Therapeutics has developed a proprietary translational platform to identify novel tumor-infiltrating Treg targets, with the aim of developing antibody-based candidate drugs to disable Treg function and restore an effective antitumor immune response.

In June 2020, Egle Therapeutics entered a strategic partnership with Takeda Pharmaceuticals, establishing a three-year research collaboration with an option agreement. Since its inception, the company has successfully raised nearly €56 million through equity financing and non-dilutive public funding, including the i-Lab Innovation Competition and DeepTech Development Grant.

During its Series A financing round in October 2021, the company raised €47 million, attracting renowned investors, including EQT Life Sciences, Bpifrance (INNOBIO 2 and Innovation 1), Fund Plus, Bioqube Factory Fund, T1D Fund, and Takeda Ventures.

In 2024, Egle Therapeutics achieved key milestones, including the launch of its Phase I/II clinical trial for EGL-001, the appointment of Michel Detheux as Chairman, and the appointment of Christophe Quéva as Chief Executive Officer.

"We are honored to receive this funding from the French government through France 2030. This recognition and immense support will help Egle Therapeutics advance its research and development programs in regulatory T cell modulation. The funding granted under the ‘Innovations in Biotherapies and Bioproduction’ call for projects will enable us to accelerate the development of EGL-001, our lead immuno-oncology therapeutic candidate. EGL-001 is currently being evaluated in a Phase I/II clinical trial in France and Spain."