Core Viewpoint - Calidi Biotherapeutics, Inc. has successfully closed a public offering, raising approximately $6.0 million in gross proceeds, which will support its ongoing development of targeted genetic medicines [1][2]. Group 1: Offering Details - The company sold a total of 12,094,631 shares of common stock and associated warrants, including the full exercise of the underwriters' option for an additional 1,575,000 shares [2]. - The Series J, K, and L warrants each have an initial exercise price of $0.50 per share, with varying terms of five years, one year, and six months from issuance respectively [5]. Group 2: Company Overview - Calidi Biotherapeutics is focused on developing targeted therapies that deliver genetic medicines to specific disease sites, utilizing its proprietary Redtail platform [7]. - The lead candidate, CLD-401, is currently in IND-enabling studies and targets non-small cell lung cancer and other high unmet medical need tumor types [8].

Vertex shares rose as much as 11% in late trading Monday after the biotech company said its drug to treat a kidney disorder met its goal in a late-stage trial https://t.co/w06hGEgZJS ...

Financial Data and Key Metrics Changes - In Q4 2025, total net revenue was $34.1 million, including $26.4 million from MIPLYFFA sales, $400,000 from OLPRUVA, and $5.6 million from net reimbursements under the global EAP [22][23] - For the full year 2025, net revenue reached $106.5 million, with $87.4 million from MIPLYFFA sales, compared to a net loss of $105.5 million in 2024 [25] - Operating expenses for Q4 2025 were $23 million, a decrease of $1.5 million year-over-year, while R&D expenses decreased by $5.8 million to $2.6 million [22][24] Business Line Data and Key Metrics Changes - MIPLYFFA generated $87.4 million in revenue for the full year 2025, with a total of 161 enrollments since launch, including 52 in the first full year of commercialization [5][6][15] - The global expanded access program (EAP) had 113 patients enrolled by the end of 2025, with ongoing efforts to expand access beyond the U.S. [8][9] Market Data and Key Metrics Changes - In the U.S., the estimated prevalence of Niemann-Pick disease type C (NPC) is approximately 900 individuals, with 300-350 currently diagnosed [7][10] - In Europe, the estimated prevalence of NPC is around 1,100 individuals, with the current EAP supporting nearly 10% of this population [9] Company Strategy and Development Direction - The company aims to redefine therapies for rare diseases, focusing on patient-centricity and innovation [4] - A strategic move to Boston is intended to enhance collaboration and access to specialized talent within the biotech ecosystem [12] - The company is pursuing a patent term extension for MIPLYFFA, which could provide additional exclusivity [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of MIPLYFFA, driven by strong clinical data and increased awareness among healthcare providers [15][16] - The company is optimistic about the continued identification of newly diagnosed patients and the overall market potential for MIPLYFFA [16][20] Other Important Information - The company has engaged the FDA regarding regulatory options to accelerate the development of celiprolol for vascular Ehlers-Danlos syndrome [12][70] - The company has a strong balance sheet with $238.9 million in cash and equivalents, allowing for independent operation and investment in growth opportunities [90] Q&A Session Summary Question: Can you provide details on the split of new diagnoses versus previously identified patients? - Management noted that there has been meaningful growth in newly diagnosed patients, attributed to clinical data strength and disease awareness campaigns [32][33] Question: What is the expected timeline for diagnosis confirmation? - The average time for test results is estimated to be about three weeks, facilitating quicker clinical decision-making [41] Question: Can you discuss persistency rates for patients on therapy? - Management indicated that it is too early to provide meaningful data on persistency but noted encouraging refill rates [46][47] Question: How is the initial experience with the Uniphar collaboration? - The company is pleased with the collaboration and expects continued growth in patient access through this partnership [48][49] Question: What is the total addressable market for diagnosed NPC patients? - Management believes they have engaged approximately 40%-50% of the diagnosed patients currently enrolled to receive MIPLYFFA [80]

As filed with the U.S. Securities and Exchange Commission on March 9, 2026. Registration No. 333-291575 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Breeze Acquisition Corp. II (Exact name of registrant as specified in its charter) | Cayman Islands | 6770 | N/A | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization ...

Summary of iBio Conference Call Company Overview - **Company**: iBio (NYSEAM:IBIO) - **Industry**: Biotechnology, specifically focusing on cardiometabolic diseases and obesity treatments Key Points and Arguments Long-term Vision - iBio pivoted into the cardiometabolic space two years ago, focusing on treatments that follow GLP-1s, which are becoming a cornerstone in obesity treatment. The company aims to address unmet needs in patient care within this space [7][8] Value Inflection Points - Upcoming milestones include: - External data from Wave and Arrowhead - Filing for Activin E by the end of the year, with potential interim data by the end of next year - Progress on bispecific myostatin activin A program, expected to enter the clinic in the second half of next year - Myostatin program acceptance in Australia, with first patient dosing anticipated in Q3 [12][12][12] IBIO-610 (Activin E Antibody) - The antibody targets the Activin E pathway at the protein level in blood, differentiating it from competitors focusing on gene-level interventions [25] - Aiming for near-complete inhibition of the pathway, which may lead to better efficacy compared to competitors [26] - Safety profile is expected to be favorable due to the extensive history of antibody use [29] - Designed for long-acting subcutaneous administration, with a half-life of approximately 100 days in humans [33] Competitive Landscape - iBio is learning from competitors' data on visceral fat and liver fat reductions, which may inform their trial designs and patient populations [35][36] - The company is particularly interested in inflammation biomarkers, which could link to cardiovascular disease protection [40][41] Regulatory Considerations - The company is cautious about regulatory pathways, emphasizing the need for endpoints that reflect real patient benefits rather than just weight loss [44][45] Patient Populations - Targeting a broad range of patients, including those with type 2 diabetes, liver fibrosis, and obstructive sleep apnea [51][52] - The potential for the drug to address weight maintenance in obesity is highlighted as a significant unmet need [49] Pipeline and Future Indications - iBio is developing a bispecific antibody targeting myostatin, GDF11, and activin A, which may address multi-organ diseases like heart failure with preserved ejection fraction [58][59] - The company is not focused on rare diseases but is open to partnerships for those indications [62] Financial Overview - iBio has cash reserves extending into Q1 2028, prioritizing the development of Activin E, bispecific, and myostatin programs [71] - Current market cap is approximately $350 million, with a fully diluted cap closer to $500 million [71] Partnership Strategy - iBio is considering partnerships for larger indications like obesity, while smaller indications may be developed independently [73] - The company is selective in partnerships, aiming to maximize shareholder value [74] Underappreciated Aspects - The team, platform, and persistence are highlighted as key strengths that differentiate iBio in the competitive landscape [77] Additional Important Content - The integration of AI in drug discovery is emphasized, allowing for the development of more effective and manufacturable antibodies [66][68] - The company is focused on optimizing both antibodies and antigens, which sets it apart from competitors [67][68]

CORAL GABLES, Fla., March 09, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced 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. Leerink Partners Global Healthcare ...

And right now we are 2 minutes away from the end of the trading day. Romaine Bostick alongside Katie Greifeld, taking you through to that closing bell. It's a global simulcast.We're joined now by Carol Massar normal end to end today. For tim Stanwick, welcome to our audiences across all of our Bloomberg platforms, television, radio, our partnership with YouTube. And I think I said this the last few days, Carol, another wild day on Wall Street.Yeah, well, the VIX has gone up, so it definitely is volatile. I' ...

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston B ...

- Transformative year for tau in AD: VY1706 clinical entry and VY7523 clinical data anticipated H2 2026 -  - Validating brain-targeted capsids in humans: expect two I.V.-delivered neuro gene therapies to enter clinic H2 2026 - - Advancing Voyager NeuroShuttle™: murine study using anti-amyloid antibody supports sustained brain exposure profile - - Ended 2025 with cash position of $202 million, expected to maintain runway into 2028 - LEXINGTON, Mass., March 09, 2026 (GLOBE NEWSWIRE) -- Voyager Therapeutics, I ...

NEW YORK and WALTHAM, Mass., March 09, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH) (“Dianthus” or the “Company”), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced that it has commenced an underwritten public offering of $400 million of shares of its common stock or, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its ...