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])

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 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 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter and year ended December 31, 2025, and provides an operational update.

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"During our fourth quarter and throughout 2025, we continued to deliver strong commercial performance, supported by the growing clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and CEO of TriSalus. "We are pleased to have exceeded our 2025 revenue guidance of 50%, delivering 53%, reflecting strong commercial execution and sustained progress on our strategic initiatives, including expansion of the TriNav platform across multiple indications beyond the liver."

"Looking ahead to 2026, we intend to deepen our engagement within the interventional radiology community by expanding our sales and commercial organizations, invest in foundational registry and clinical studies to further demonstrate the value of PEDD in the liver and our new applications, and continue to advance innovative PEDD product launches that enhance and differentiate our embolization toolkit. The $46 million in growth capital raised through our recent public offering, will substantially broaden and accelerate these strategic initiatives and drive support broader adoption of the PEDD platform. Based on our performance and positive outlook for 2026, we are reaffirming our revenue guidance of $60 million to $62 million. We look forward to 2026 confident in the commercial opportunities before us and energized by our long-term vision of bringing our PEDD technology to a wider range of patients and improving clinical outcomes."

Highlights for Fourth Quarter 2025 and Recent Weeks

Generated $13.2 million in net sales, a 60% increase year-over-year, and sequential growth of 14% over the third quarter 2025.
Gross margin increased to 86.7% for the quarter ended December 31, 2025, as compared to 85.3% for the quarter ended December 31, 2024.
Improved Adjusted EBITDA to a loss of $0.9 million for the quarter ended December 31, 2025, compared to a loss of $5.7 million for the quarter ended December 31, 2024.
Delivered another strong commercial performance, with expanding use of TriNav in liver embolization, and continued further development of new applications for new clinical settings focused on the interventional radiology call point.
Subsequent to the fourth quarter, the Company raised $46 million in gross proceeds via a public offering to support continued growth.
As of December 31, 2025, cash and cash equivalents totaled $20.4 million.
Announced the appointment of veteran healthcare investor Michael Stansky to our Board of Directors in February 2026.
Hosted Virtual KOL Event to Discuss the TriNav Infusion System for the Treatment of Uterine Fibroids November 12, 2025.
Hosted Virtual KOL Event to Discuss the TriNav Infusion System for the Treatment of Symptomatic Thyroid Disease December 15, 2025.
Launched the TriNav XP Infusion System. TriNav XP is engineered specifically for compatibility with larger embolic particles (beads up to and including 700 μm), is designed with a more flexible distal tip for improved trackability, is available in both 130 cm and 150 cm lengths, and is recommended for use in 1.5 mm to 3.5 mm vessels.
Full Year 2025 Financial Results

Revenue, all from sales of the TriNav system, was $45.2 million for the year ended December 31, 2025, an increase of 53% compared to the same period in 2024. Revenue growth was driven primarily by increased TriNav unit sales within liver directed applications.
Gross profit increased by $12.9 million for the year ended December 31, 2025, as compared to the year ended December 31, 2024, while gross margin decreased from 86.1% to 84.6% year over year. The increase in gross profit was due primarily to the increase in TriNav units sold, while the year-over-year decline in gross margin was primarily driven by lower manufacturing efficiency associated with newly launched products, which is a dynamic we expect to improve as production scales and processes mature.
Research and Development (R&D) expenses decreased by $2.7 million for the year ended December 31, 2025, as compared to the year ended December 31, 2024. The decrease was primarily due to the close-out of clinical trial expenses related to nelitolimod.
Sales and Marketing (S&M) expenses increased by $2.9 million for the year ended December 31, 2025, as compared to the year ended December 31, 2024. The increase was primarily due to an increase in performance related compensation driven by the increase in sales during the year ended December 31, 2025 compared to prior year.
General & Administrative (G&A) expenses increased by $3.5 million for the year ended December 31, 2025, as compared to the year ended December 31, 2024. The increase was primarily due to the acceleration of a non-cash stock-based compensation award of approximately $1.8 million, the revision of certain patent-related expenses from research and development to general and administrative expenses of approximately $0.7 million, and professional services as a result of the timing of various filing and audit related expenses.
Operating losses were $26.9 million, compared to operating losses of $36.2 million for the same period in the prior year. The decrease was primarily driven by the increase in revenue, highlighting strong operating leverage.
Net loss attributable to common stockholders was $69.7 million in the year ended December 31, 2025, compared to $33.2 million for the same period in the prior year, primarily driven by the conversion of our preferred stock to common stock during the third quarter of 2025, resulting in approximately $30.5 million net loss attributable to common stockholders.
Improved Adjusted EBITDA to a loss of $17.2 million for the year ended December 31, 2025, compared to a loss of $30.0 million for the year ended December 31, 2024.
The basic and diluted loss per share was $1.84, compared to $1.31 for the same period in 2024. This increase was primarily due to the conversion of preferred stock to common stock.
2026 Guidance

The Company anticipates 2026 revenues in the range of $60 million to $62 million.

Conference Call

The Company will host a conference call and webcast today, March 5, 2026 at 4:30 PM eastern time to discuss its financial results for the quarter and year ended December 31, 2025. Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.

(Press release, TriSalus Life Sciences, MAR 5, 2026, View Source [SID1234663312])

On March 5, 2026 SimBioSys, an AI-driven precision medicine company revolutionizing how cancer is understood and treated, reported that compelling clinical data from its multi-institutional study has been selected for presentation at the Miami Breast Cancer Conference (MBCC), being held March 5–8, 2026 in Miami, FL.

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The abstract, titled "An AI Digital Twin Compares Favorably to Radiologists for Landmark Identification and Measurement in Early-Stage Breast Cancer: A Retrospective, Multi-Institution Clinical Study," will be presented as Poster #040 on Thursday, March 5, 2026. The study evaluates the accuracy of TumorSight Viz (v1.3), an AI-driven digital twin platform that generates patient-specific 3D representations from standard breast MRI to support anatomical assessment and surgical strategy.

"This body of clinical evidence represents an important milestone in validating how AI-generated digital twins can deliver reproducible and radiologist-comparable insight into tumor anatomy," said Stacey Stevens, President and CEO of SimBioSys. "These findings underscore our commitment to advancing tools that support greater precision, consistency, and confidence in preoperative assessment — ultimately helping multidisciplinary teams make more informed decisions in breast cancer care."

Key outcomes from the retrospective multi-institution analysis include:

AI performance comparable to expert radiologists — TumorSight Viz’s disease measurements fell within inter-reader variability for US-board certified, fellowship-trained breast radiologists.
High spatial concordance — TumorSight Viz achieved a 0.92 surface Dice score, indicating strong agreement between the AI’s tumor delineation and measurements confirmed by expert radiologists.
Consistent results across imaging environments — Performance remained stable regardless of MRI system manufacturer, field strength, tumor subtype, or clinical site.
Rapid quantitative output — TumorSight Viz produced landmark features and measurements in minutes per case following MRI upload.
These results highlight the potential for AI-enabled digital twin technology to provide objective, anatomy-specific insights that complement expert clinical interpretation — a critical need in surgical planning for early-stage breast cancer.

"Accurate visualization and quantitation of tumor extent are fundamental to surgical decision-making. Technologies that can reliably mirror radiologist assessments have the potential to improve clarity, reproducibility, and communication across care teams," added Barry Rosen, MD, FACS, Breast Surgical Oncologist and Chief Medical Officer of SimBioSys.

This study adds to a growing portfolio of clinical evidence supporting the utility of AI-driven quantitative imaging tools — reinforcing SimBioSys’ mission to accelerate adoption of data-driven decision support across breast cancer care.

(Press release, SimBioSys, MAR 5, 2026, View Source [SID1234663311])