Core Viewpoint - Cocrystal Pharma, Inc. has announced that its novel influenza PB2 inhibitor CC-42344 demonstrates strong antiviral activity against the highly pathogenic H5N1 avian influenza strain, indicating potential for treating both pandemic and seasonal influenza infections [1][3][4] Company Summary - Cocrystal Pharma is a clinical-stage biotechnology company focused on discovering and developing antiviral therapeutics targeting the replication processes of various viruses, including influenza and coronaviruses [7] - The company employs structure-based technologies and expertise to create first- and best-in-class antiviral drugs [7] Product Development - CC-42344 is an investigational drug candidate that binds to a conserved active site of the PB2 protein, inhibiting viral replication [2][3] - The virology study showed that CC-42344 has an EC50 of 0.003 µM against the H5N1 strain, making it approximately 1,000-fold more potent than Tamiflu, which has an EC50 of 2.69 µM [3][8] - Initial data from the development of CC-42344 indicates a favorable safety and tolerability profile [3][4] Market Potential - The influenza market is valued in the multibillion-dollar range, with influenza responsible for an estimated $11.2 billion in direct and indirect costs annually in the U.S. [4] - On average, about 8% of the U.S. population contracts influenza each season, highlighting the significant public health concern [4] Industry Context - The emergence of highly pathogenic avian influenza strains poses a risk of adaptation for human-to-human transmission, raising concerns about potential influenza pandemics [2][5] - Recent studies indicate extremely low population immunity to H5N1 viruses in the U.S., suggesting a vulnerability to outbreaks [6]

Core Insights - Cocrystal Pharma, Inc. will participate in a fireside chat at the Noble Capital Markets' 2025 Emerging Growth Virtual Equity Conference on June 5, 2025 [1] - The company is a clinical-stage biotechnology firm focused on developing antiviral therapeutics targeting various viruses [3] Company Overview - Cocrystal Pharma specializes in discovering and developing novel antiviral drugs aimed at noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses [3] - The company utilizes unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral therapeutics [3] Event Details - Registered investors can request one-on-one meetings with Cocrystal management through the conference registration platform [2] - A video webcast of the presentation will be available approximately 48 hours after the event and archived for 90 days on the company's website and Channelchek [2]

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Core Viewpoint - Traws Pharma is advancing the development of tivoxavir marboxil (TXM) as a treatment for bird flu and seasonal influenza, with recent FDA feedback guiding their regulatory strategy and clinical study plans [1][2][3]. Group 1: FDA Interaction and Development Plans - The FDA provided written responses regarding the development paths for TXM, including the potential use of the Animal Rule for approval [1][2]. - Traws Pharma is requesting a Type D meeting with the FDA to clarify next steps in the development process for TXM [2]. - The company aims to conduct a combined clinical study involving subjects infected with seasonal and bird flu [2]. Group 2: Therapeutic Efficacy and Urgency - Positive therapeutic effects of TXM have been observed in three animal models of bird flu, reinforcing the need for rapid progression towards stockpiling and pandemic readiness [3]. - Traws Pharma has initiated discussions with the Biomedical Advanced Research and Development Authority (BARDA) for stockpiling TXM in preparation for potential pandemics [3]. - The historical context of H5N1 virus outbreaks, which have had death rates up to 50%, underscores the urgency of these actions [3]. Group 3: Product Overview and Market Opportunity - TXM is an investigational oral small molecule designed as a single-dose treatment for bird flu and seasonal influenza, showing potent in vitro activity against various influenza strains [4]. - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health organizations and government tenders, with additional potential from pandemic outbreaks [4]. - The data supporting TXM's development as a treatment for both bird flu and seasonal flu is considered robust [4].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Intellia Therapeutics, Inc. regarding breaches of fiduciary duties by the board of directors following a class action complaint related to the company's Phase 1/2 study and subsequent reorganization [1][2][3] Group 1: Legal Investigation - A class action complaint was filed against Intellia on February 11, 2025, with a class period from July 30, 2024, to January 8, 2025 [1] - The investigation focuses on whether Intellia's board of directors failed to disclose critical information regarding the demand for viral-based editing and the inefficiency of the NTLA-3001 program [2] Group 2: Company Reorganization - On January 9, 2025, Intellia announced a reorganization, halting all NTLA-3001 research and reducing its workforce by 27% in 2025 [3] - The decision to discontinue NTLA-3001 was part of a broader strategy to focus resources on other pharmaceutical developments [3] Group 3: Stock Price Impact - Following the announcement of the reorganization, Intellia's stock price dropped from $12.02 per share on January 8, 2025, to $10.20 per share on January 10, 2025 [4]

Cidara Therapeutics (CDTX) Update / Briefing May 22, 2025 10:00 AM ET Speaker0 Good morning, and welcome to the Sadara Therapeutics Investor Day. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Sadara website following the conclusion of the event. I'd now like to turn the call over to Doctor. Jeff Stein, President and Chief Executive Officer of Sada ...

Core Insights - IMUNON, Inc. announced promising results from its Phase 1 clinical trial of IMNN-101, a DNA plasmid vaccine utilizing the PlaCCine technology platform, demonstrating better durability and safety compared to mRNA vaccines [1][2][4] Group 1: Clinical Trial Results - The Phase 1 trial involved 24 healthy volunteers and showed that IMNN-101 provided a durable immune response, with a median increase of up to 3-fold in serum neutralizing antibody titers at six months post-vaccination [1][6] - The highest observed increase in neutralizing antibody titers among participants was 8-fold from baseline, indicating a strong immune response [1][4] - IMNN-101 was well tolerated with no serious adverse effects reported, reinforcing its safety profile [1][2] Group 2: Technology and Competitive Advantages - The PlaCCine technology platform offers several advantages, including stability at workable temperatures and ease of manufacturing compared to existing mRNA vaccines [2][5] - IMNN-101 is designed to accommodate single or multiple antigens, providing flexibility in vaccine development [5] - The vaccine demonstrated cross-reactivity against the Omicron XBB1.5 variant and other newer variants, indicating its potential effectiveness against emerging pathogens [4][6] Group 3: Future Development and Strategic Goals - The company is in discussions for further development of the PlaCCine platform for prophylactic vaccines, aiming for long-term strategic partnerships to advance these technologies [2][3] - IMUNON's broader goal is to expand its vaccine toolkit to address unaddressed infectious diseases and reduce hospitalizations [3][8] - The company is also advancing its other clinical programs, including IMNN-001 for advanced ovarian cancer, showcasing its commitment to innovative treatments [7][8]

Core Viewpoint - Cocrystal Pharma is advancing its antiviral product pipeline, particularly focusing on CDI-988, a novel oral pan-viral protease inhibitor targeting norovirus and coronaviruses, with promising in vitro results and plans for human challenge studies [2][9][10]. Antiviral Product Pipeline Overview - The company utilizes a structure-based drug discovery platform to develop broad-spectrum antivirals that target conserved regions of viral enzymes, enhancing efficacy against mutations and reducing side effects [3]. - CDI-988 has shown superior antiviral activity against major norovirus strains, including GII.17 and GII.4, and is positioned as a first-in-class treatment [2][9]. Influenza Programs - Influenza poses a significant global health threat, with approximately 1 billion cases and up to 650,000 deaths annually [4]. - Cocrystal's CC-42344, a PB2 inhibitor, has demonstrated excellent in vitro activity against various influenza A strains, including those resistant to existing antivirals [4][8]. Norovirus Program - Norovirus is responsible for an estimated 21 million cases in the U.S. annually, leading to significant healthcare costs and hospitalizations [6]. - There is currently no effective treatment or vaccine for norovirus, highlighting the potential market opportunity for CDI-988 [5][6]. SARS-CoV-2 and Other Coronavirus Program - CDI-988 has shown potent in vitro activity against SARS-CoV-2 and other coronaviruses, with the global COVID-19 therapeutics market projected to exceed $16 billion annually by 2031 [7]. Financial Results - For Q1 2025, research and development expenses were $1.4 million, down from $3.0 million in Q1 2024, primarily due to reduced personnel costs [11]. - The net loss for Q1 2025 was $2.3 million, or $0.23 per share, compared to a net loss of $4.0 million, or $0.39 per share, in Q1 2024 [12]. - As of March 31, 2025, the company reported unrestricted cash of $6.9 million, down from $9.9 million at the end of 2024 [13].

Core Insights - Traws Pharma is advancing two investigational antiviral therapies: tivoxavir marboxil (TXM) for bird flu and seasonal flu, and ratutrelvir for COVID-19, including Long COVID [2][3][4] - The company aims to accelerate the approval process for these therapies through regulatory interactions, including a briefing submitted to the FDA for TXM [3][4] - Financial results indicate a net income of $21.5 million for Q1 2025, primarily due to a change in fair value of warrant liability, contrasting with a net loss of $5.0 million in Q1 2024 [6][9] Product Development - **Tivoxavir Marboxil (TXM)**: - A single-dose investigational CAP-dependent endonuclease inhibitor targeting H5N1 bird flu and seasonal flu, with a multi-billion dollar market opportunity [4][12] - Recent studies show significant antiviral activity, including reduced viral burden in animal models [4][10] - Preparations for FDA discussions regarding accelerated approval are ongoing [10] - **Ratutrelvir**: - An investigational oral Main protease inhibitor for acute COVID treatment, with potential to prevent COVID rebound and Long COVID [5][10] - Preclinical studies indicate potent suppression of resistant virus and favorable pharmacokinetic profiles [10][13] Financial Overview - As of March 31, 2025, Traws Pharma had approximately $15.9 million in cash and equivalents, down from $21.3 million at the end of 2024, sufficient to support operations into Q1 2026 [6][21] - Revenue for Q1 2025 was $57,000, slightly up from $56,000 in Q1 2024 [6][24] - R&D expenses increased to $2.5 million in Q1 2025 from $1.9 million in Q1 2024, reflecting heightened investment in virology programs [7][24] - General and administrative expenses decreased to $2.8 million in Q1 2025 from $3.4 million in Q1 2024 [8][24] Management Updates - Iain D. Dukes was appointed Interim CEO following the retirement of Werner Cautreels [5] - Jack Stover was named Chairman of the Board on April 15, 2025 [5]

Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics (CADL) is a clinical-stage biotech company focused on developing viral immunotherapy for difficult-to-treat cancers, utilizing two main platforms: HSV and adenoviral [1] Key Assets and Development Pipeline - The most advanced asset is CAN2409, an adenoviral platform targeting prostate cancer, with positive Phase 3 data recently unveiled and a BLA submission expected by the end of 2026 [2] - CAN2409 is also in development for non-small cell lung cancer (NSCLC) and pancreatic cancer, with fast track designation for all indications [3] - Another asset, CAN310, is a classical oncolytic virus in development for recurrent high-grade glioma [3] Clinical Data and Efficacy - CAN2409 has been administered to over 1,000 patients and shows synergy with radiation therapy, particularly in prostate cancer [4][5] - In NSCLC, a significant reduction of nearly 50% in tumor volume was observed in treated patients [6] - In recurrent high-grade glioma, median overall survival of at least 12 months was achieved with a single injection, compared to a median survival of 6-9 months in untreated patients [7] Discovery Platform - The Enlighten platform utilizes AI for data mining to design viral immunotherapies, aiming to combine with checkpoint inhibitors or cellular therapies for challenging cancers [7] Prostate Cancer Opportunity - Prostate cancer represents a multi-billion dollar opportunity due to the high prevalence and unmet medical need, especially in localized cases [11] - The trial included 745 patients, showing a 30% reduction in disease recurrence or death compared to placebo [14] - Significant effects on PSA levels, a key biomarker for recurrence, were noted, with a higher percentage of patients achieving pathological complete response [15] Safety and Tolerability - CAN2409 demonstrated a favorable safety profile, comparable to a prostate biopsy, with good tolerability among patients [15] Future Plans and Financials - Candel is ramping up CMC activities in preparation for commercial launch and is engaging with KOLs and medical affairs [16] - The company reported cash and cash equivalents of $92 million as of December, sufficient to support BLA submission in 2026 [22] Additional Insights - The pancreatic cancer trial indicated a significant improvement in median overall survival, with ongoing plans for a larger Phase 2 trial [17] - In lung cancer, adding CAN2409 to treatment for patients not responding to checkpoint inhibitors resulted in a median overall survival of 21 months, doubling expectations [20] Leadership and Achievements - The leadership team has extensive experience in drug development, and the company has exceeded its previous clinical milestones [21] Regulatory Engagement - Continuous discussions with the FDA regarding the BLA submission process are ongoing, focusing on CMC manufacturing and clinical package preparation [23][24]