On March 9, 2026 Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ over-allotment option for gross proceeds of approximately $6.0 million, prior to deducting underwriting commissions and offering expenses.

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In connection with the offering, the Company sold 12,094,631 shares of common stock (or pre-funded warrants in lieu thereof) Series J warrants to purchase 12,094,631 shares of common stock, Series K warrants to purchase 12,094,631 shares of common stock, and Series L warrants to purchase 12,094,631 shares of common stock, including the full exercise of the underwriter’s option to purchase 1,575,000 shares of common stock and accompanying warrants..

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

The securities described above were 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 and the related registration statement filed under Rule 462(b) of the Securities Act of 1933, as amended, which became automatically effective upon filing. A final prospectus supplement was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus 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].

The Series J warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring five years from issuance. The Series K warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring one year from issuance. The Series L warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring six months from issuance. The warrants issued in this offering each include a reset of the exercise price on two separate occasions: (i) on the forty-fifth (45th) calendar day following the date of issuance and (ii) the sixth (6th) trading day immediately following the date on which a reverse stock split is approved and deemed effective during the fiscal year ended December 31, 2026.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will 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 9, 2026, View Source [SID1234663488])

On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported that Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer, will participate in the Leerink Partners Global Healthcare Conference being held in Miami, Florida, from March 8-11, 2026.

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Leerink Partners Global Healthcare Conference Details
Format: Fireside Chat
Date Tuesday, March 10, 2026
Time: 8:40 AM ET
Webcast: Click Here

Management will also be available for one-one-one investor meetings during the conference. Please contact your Leerink Partners representative to schedule a meeting.

The webcast can also be accessed on the Events page the Investors section of the Relmada website at View Source An archived replay will be available for 90 days following the conclusion of the event.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663370])

On March 9, 2026 Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, reported a strategic expansion of its partnership with The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients. Through this partnership, Medidata AI Study Build technology will power Stemline’s oncology portfolio to initiate clinical trials faster to meet the urgent needs of people living with cancer. The announcement follows the milestone of Stemline launching its first oncology study entirely in-house, using the Medidata Data Experience.

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AI for Impact
By transitioning to unified, AI-driven workflows, Stemline is further modernizing the trial lifecycle from protocol to patient. AI Study Build allows Stemline to leverage a vast clinical data set of more than 38,000 trials to automate configurations — reducing the time between protocol finalization and trial startup from months to weeks with:

Rapid study startups: Accelerating the study builds at an unprecedented pace
Internal agility: Empowering Stemline to build and launch future oncology studies independently, powered by the Medidata Data Experience
Stronger oncology research at speed: Delivering high-quality data faster to meet the urgent requirements of research into different cancers

"Stemline is deepening its commitment to advancing oncology research by embracing our established AI foundation and latest AI Study Build capabilities," said Wayne Walker, senior vice president, Data Experience, Medidata. "Stemline’s commitment to adopting Medidata AI-powered technologies sets a high bar for how sponsors can independently harness a unified platform to accelerate the delivery of new therapies for patients. Together, we are setting a new standard for how oncology trials are built and executed."

"Innovation is at the core of our mission to bring transformational treatments to patients, and we recognize the impact of Medidata AI to further streamline our workflows," said Elcin Barker Ergun, CEO of the Menarini Group. "Our expanded partnership with Medidata supports our internal expertise, enabling us to advance crucial research and reflecting the urgency of our team in bringing new options to patients as quickly and safely as possible."

A Foundation of Trusted Collaboration
This expansion builds upon a 14-year relationship between the Menarini Group and Medidata. While the Menarini Group has long utilized the Medidata platform — including Medidata Rave EDC and Medidata eCOA — to manage the end-to-end cycle of its clinical studies, the move to Medidata AI Study Build marks a significant transition. By combining the Menarini Group’s clinical expertise with Medidata’s established AI and Data Experience leadership, Stemline is positioned to advance its oncology portfolio with unprecedented speed and independence.

(Press release, Medidata, MAR 9, 2026, View Source [SID1234663389])

On March 9, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, reported that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $40 million, before deducting placement agent fees and other expenses. The private placement includes participation from Coastlands Capital, Commodore Capital, Vivo Capital and other new and existing institutional investors.

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In the private placement, AN2 Therapeutics is selling 8,245,611 shares of common stock at a price of $2.85 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 5,789,493 shares of common stock at a price of $2.84999 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.00001 per share of common stock, will be exercisable immediately and will be exercisable until exercised in full, subject to ownership limitations. The private placement is expected to close on March 10, 2026, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules).

Leerink Partners is acting as exclusive placement agent for the private placement.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. AN2 Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock to be issued in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants to be issued in the private placement.

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

(Press release, AN2 Therapeutics, MAR 9, 2026, View Source [SID1234663349])

On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

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The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC.

"These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile," said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. "Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026."

"I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies," said Max Kates, MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.

Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:

Clinical Results (Response Data)
Complete Response
Anytime 95% (36/38)
3 month 87% (33/38)
6 month 86% (25/29)
9 month 85% (22/26)
12 month 76% (19/25)
12-month KM analysis 83%
N=48 patients dosed in overall population; KM: Kaplan-Meier analysis

Efficacy in BCG-Unresponsive Subpopulation**:

Clinical Results (Response Data)
Complete Response
Anytime 94% (16/17)
3 month 82% (14/17)
6 month 86% (12/14)
9 month 91% (10/11)
12 month 80% (8/10)
12-month KM analysis 84%
N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis
No patient had progression to muscle-invasive disease
No patient underwent a radical cystectomy
No patients had a ≥ Grade 3 treatment related adverse event (TRAE)
No patients discontinued treatment due to AEs
Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE).
Among treatment-related AEs,
54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1)
8% had an asymptomatic positive urine culture
8% had hematuria
Phase 3 RESCUE Registrational Pathways:

Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects ~75,000 patients/year in the US.

Primary endpoint: Disease Free Survival (DFS)
Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS), quality of life (QOL) metrics
Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy.

Primary endpoint: Complete response (CR) rate at any time
Key secondary endpoint: Duration of response (DOR), progression free survival (PFS), recurrence free survival (RFS) amongst responders
Expected Upcoming NDV-01 Milestones:

NDV-01 United States IND clearance – Mid-2026
Phase 3 RESCUE Program Initiation – Mid-2026
Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026
About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in approximately 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663371])