On March 5, 2026 Liberate Bio, Inc., a biotechnology company developing genetic medicines that deliver RNA therapies directly to immune cells, reported that it has secured exclusive and non-exclusive licenses to key patents covering chimeric antigen receptor (CAR) designs optimized for myeloid cells, including monocytes and macrophages.

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The licensed intellectual property, originating from Carisma Therapeutics and the University of Pennsylvania, includes methods and designs for CAR constructs specifically engineered for function within myeloid cell populations. These designs complement Liberate’s proprietary lipid nanoparticle (LNP) delivery platform, which selectively programs monocytes and macrophages in vivo.

With both optimized CAR-sequence IP and cell-selective delivery technology, Liberate Bio now integrates the critical components needed to advance in vivo CAR-M therapies toward clinical evaluation.

"This licensing agreement meaningfully strengthens our clinical programs," said Walter R. Strapps, Ph.D., Chief Scientific Officer of Liberate Bio. "Myeloid cells have unique biology distinct from T cells, and CAR constructs optimized for their activation and persistence are essential. By combining validated methods for CAR designs with our myeloid-selective LNP platform, we are building a differentiated and highly integrated approach to in vivo cell therapy."

Liberate’s proprietary RAPTOR platform directly screens lipid nanoparticles (LNPs) in non-human primates to identify delivery vehicles that target extrahepatic immune cells. As previously reported, Liberate’s lead LNP achieved greater than 99% depletion of circulating B cells in non-human primates through selective programming of monocytes and macrophages

"In vivo CAR-M represents a new chapter in immune reprogramming," said Shawn P. Davis, Ph.D., Chief Executive Officer of Liberate Bio. "By uniting best-in-class delivery with optimized myeloid CAR designs, we are establishing a durable foundation for a scalable and potentially safer alternative to CAR-T — one capable of reaching broader patient populations across autoimmune and oncology indications."

Liberate Bio plans to advance its first in vivo CAR-M candidate toward IND-enabling studies, with the goal of supporting the first clinical evaluation in the second half of 2026 through an investigator-initiated trial.

(Press release, Liberate Bio, MAR 5, 2026, View Source [SID1234663313])

On March 5, 2026 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on its business.

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Recent Corporate Highlights:

CorMedix announces $128.6 million of net revenue for the fourth quarter of 2025, largely driven by continued utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $91.2 million of net revenue in the quarter.
For the full-year 2025, CorMedix achieved total revenue of $311.7 million and pro forma total revenue of $401.3 million.(1)
In the fourth quarter of 2025, the Company recognized Net Income of $14.0 million and adjusted EBITDA of $77.2 million.(2) Basic and Fully Diluted EPS were $0.18 and $0.16 per share, respectively.
CorMedix reiterates previously established guidance for 2026, including net revenue of between $300 and $320 million and adjusted EBITDA of between $100 and $125 million.
CorMedix announced in early February that its Board of Directors approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock.
As highlighted during the Company’s recent Analyst Day, CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO (rezafungin for injection) in the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in the first half of 2027.
Cash and short-term investments, excluding restricted cash, at December 31, 2025 amounted to $148.5 million.
Joe Todisco, CorMedix Chairman and CEO, commented, "I am proud of the Company’s progress over the past year as we have accelerated the expansion of patient access for DefenCath, completed our acquisition and integration of Melinta, and saw progress in our two ongoing Phase 3 clinical programs for Rezzayo prophylaxis and DefenCath in TPN. With the announcement of our share repurchase program and multiple near-term milestones on the horizon, most notably the Rezzayo ReSPECT phase III data, CorMedix is focused on driving business growth and shareholder value over the year ahead."

Fourth Quarter and Full Year 2025 Financial Highlights

For the fourth quarter of 2025, CorMedix recorded $128.6 million in net revenue, comprised of $91.2 million in sales of DefenCath and $37.4 million in revenue associated with the Melinta portfolio, an increase from $31.2 million in net revenue in the comparable period of 2024. The fourth quarter of 2025 was the first full quarter of Melinta portfolio revenue after the closing of the acquisition in August 2025.

Total operating expenses in the fourth quarter of 2025 were $48.2 million, compared with $17.1 million in the fourth quarter of 2024, an increase of approximately 182%. The increase of $31.1 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter. Fourth quarter 2025 operating expenses also included $4.1 million of non-recurring costs, including severance and other integration-related costs associated with the Melinta acquisition. Other drivers of increases year-over-year include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN.

For the fourth quarter of 2025, the Company recorded $14.0 million in net income, or $0.16 per diluted share, compared with net income of $13.5 million, or $0.20 per diluted share, in the fourth quarter of 2024. Net income for the fourth quarter of 2025 included tax expense, primarily associated with the utilization of the Company’s deferred tax assets, of $42.4 million. These deferred tax assets were established in the third quarter of 2025 and are associated with the anticipated future use of CorMedix Net Operating Loss (NOL) carryforwards due to projected future sustained profitability of the Company. Also for the fourth quarter of 2025, CorMedix reported Adjusted EBITDA of $77.2 million, compared to adjusted EBITDA of $15.3 million in the fourth quarter of 2024.

For the year ended December 31, 2025, CorMedix recorded $311.7 million in total revenue, including $258.8 million in net sales of DefenCath and $52.9 million in net revenue from the legacy Melinta portfolio. Pro forma 2025 revenue, which reflects full-year revenue from the Melinta portfolio in addition to full-year net sales of DefenCath, was $401.3 million. The Company reported net income of $163.0 million, or $2.04 per diluted share, compared with a net loss of $17.9 million, or ($0.30) per share, in 2024. Net income was driven primarily by an increase in sales of DefenCath, and, to a lesser extent, net revenue from the acquisition of Melinta, partially offset by higher operating expenses.

Operating expenses during the year ended December 31, 2025 totaled $125.6 million compared with $62.6 million for 2024, an increase of $63.0 million, or 101%. The increase over the prior year was driven primarily by the acquisition of Melinta, including the contribution of operating expenses from Melinta’s business for the period from August 29, 2025 through the end of the year as well as transaction, integration and severance costs. Other drivers of the year-over-year increase include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN.

The Company reported cash, cash equivalents and short-term investments of $148.5 million at December 31, 2025, excluding restricted cash.

(1) Pro Forma Total Revenue was prepared by combining the financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025.

(2) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See "Non-GAAP Financial Measures" on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 5, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

March 5, 2026 @ 8:30am ET

Domestic: 1-844-676-2922
International: 1-412-634-6840
Webcast: Webcast Link

(Press release, CorMedix, MAR 5, 2026, View Source [SID1234663295])

On March 5, 2026 Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer using its Helicon peptide platform to drug historically undruggable targets, reported preliminary clinical and preclinical data at the 11th Biennial Meeting of the International Society for Gastrointestinal Hereditary Tumours (InSiGHT) supporting the therapeutic potential of its lead investigational candidate, zolucatetide — the first and only direct inhibitor of the β-catenin:TCF interaction — in patients with familial adenomatous polyposis (FAP).

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In the company’s ongoing Phase 1/2 trial, a patient with FAP and an associated desmoid tumor treated with zolucatetide demonstrated significant improvement in duodenal polyposis at 60 weeks following initiation of treatment. Substantial reductions in polyp number and size compared with a pre-treatment evaluation nearly two years prior were observed, consistent with downstaging from Spigelman stage II to stage I. The patient also sustained a 52.2% reduction in desmoid tumor diameter. No treatment-related serious adverse events or discontinuations have been reported.

Complementary preclinical findings confirmed dose dependent inhibition of β-catenin transcriptional activity in APC mutant tumor cells leading to reduced polyp formation in a mouse model of FAP at exposures relevant to the ongoing clinical trial. Together with the observed clinical activity, these findings support direct β-catenin inhibition as a disease-modifying approach in FAP.

"Patients with FAP face a lifetime of intensive surveillance and often prophylactic colectomy, yet there are no approved therapies," said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "These early findings suggest that directly inhibiting β-catenin, the key driver of tumor formation in FAP, may offer a new way to intervene at the source of disease. Our goal is to move beyond managing polyp burden and toward altering the course of disease for patients suffering from FAP."

FAP is a rare inherited disorder, impacting an estimated 34,000 people in the U.S., caused by germline loss-of-function mutations in the APC gene, leading to persistent activation of Wnt/β-catenin signaling and the development of hundreds to thousands of pre-cancerous colorectal adenomas with near-inevitable progression to colorectal cancer if left untreated. Management often requires prophylactic colectomy at a young age — a life-altering surgery — yet it does not prevent continued Wnt-driven manifestations, such as duodenal polyposis, rectal polyposis and occasionally desmoid tumors. These realities underscore the need for systemic therapies that directly target the underlying molecular driver of disease.

The Wnt/β-catenin pathway is a central oncogenic driver across a broad spectrum of rare and common solid tumors, implicated in millions of cancer cases annually. Despite its well-established role in tumor biology, direct inhibition of β-catenin — particularly its interaction with TCF transcription factors, the key downstream node within the pathway — has until now been considered "undruggable."

Beyond FAP, zolucatetide is being evaluated across a broad range of rare and common Wnt/β-catenin-driven tumor types, with early clinical data demonstrating single-agent activity in desmoid tumors – an indication that received Fast Track Designation from the FDA late last year, adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC; shared at the JP Morgan Healthcare Conference) and several other tumor types. Data also support further evaluation of rational combination approaches in biologically complex tumors, including for the treatment of microsatellite-stable colorectal cancer.

The company plans to share additional data readouts in 2026 from its ongoing Phase 1/2 trial of zolucatetide, in which more than 150 patients have been dosed to date.

About Zolucatetide (Previously FOG-001)

Zolucatetide is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors and is currently in clinical development. By directly targeting the β-catenin:TCF protein-protein interaction, zolucatetide is intended to block the Wnt signaling pathway irrespective of the various APC and β-catenin mutations that typically drive disease.

Zolucatetide combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: zolucatetide acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and zolucatetide blocks the Wnt pathway at the key downstream node, disrupting the interaction between β-catenin and the TCF transcription factors, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis.

Zolucatetide is currently being evaluated in a Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors. Zolucatetide has received Fast Track Designation for the treatment of desmoid tumors from the U.S. Food and Drug Administration (FDA).

About the Phase 1/2 trial of Zolucatetide

Zolucatetide is being evaluated in a Phase 1/2 multicenter, open-label study (NCT05919264) assessing its safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity. The trial includes dose-escalation and dose-expansion phases and is testing zolucatetide both as a monotherapy and in combination with other anticancer agents in patients with advanced or metastatic solid tumors likely or known to harbor a Wnt pathway–activating mutation (WPAM).

(Press release, Parabilis Medicines, MAR 5, 2026, View Source [SID1234663314])

On March 5, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that it has closed on a financing of $17.5 million in gross proceeds, with Paulson Investment Company acting as placement agent.

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The demand from both new and current investors highlights confidence in CytoDyn’s clinical progress and its versatile development strategy in immuno-oncology, exploring a number of potential roles for leronlimab – the Company’s first-in-class humanized monoclonal antibody that targets the CCR5 receptor.

"The successful completion of this financing in a challenging capital markets environment reflects meaningful investor support for our clinical strategy," said Robert E. Hoffman, CFO of CytoDyn. "The financing strengthens our balance sheet and is expected to fund current operations into 2027, supporting continued advancement of our clinical programs and strategic priorities. We appreciate the support of both new and existing investors, which underscores confidence in the continued development of leronlimab and its potential role in oncology, as we remain focused on disciplined execution and long-term value creation."

Net proceeds from the financing will primarily support the advancement of CytoDyn’s clinical development programs, including ongoing and planned trials, regulatory engagement, and data analysis. Additional funds may be allocated toward manufacturing readiness, regulatory and compliance infrastructure, and general working capital.

For more information on the Company’s recent fundraising activities, including key terms and conditions of some of the agreements, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on March 5, 2026.

(Press release, CytoDyn, MAR 5, 2026, View Source [SID1234663296])

On March 5, 2026 Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it intends to offer and sell, subject to market and other conditions, units consisting of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, in an underwritten public offering. Each share of common stock or pre-funded warrant will be sold with accompanying common warrants to purchase shares of common stock (or a pre-funded warrant in lieu thereof). The shares of common stock, pre-funded warrants and/or common warrants comprising the units will be separated immediately upon issuance. The purchase price of each pre-funded warrant will equal the price per share at which shares of common stock are being sold to the public in the offering, minus $0.001, the per share exercise price of each pre-funded warrant. In addition, the Company expects to grant the underwriters a 45-day option to purchase up to an additional 15% of the number of shares of common stock and/or common warrants to purchase shares of its common stock offered in the public offering at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock, pre-funded warrants and common warrants are being offered by the Company.

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The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager for the offering.

Calidi intends to use the net proceeds from the offering for working capital and for general corporate purposes.

The securities described are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284229), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 7, 2025. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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

(Press release, Calidi Biotherapeutics, MAR 5, 2026, View Source [SID1234663315])