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X @Bloomberg
Bloomberg· 2025-08-12 20:42
As the US government ends contracts to make vaccines using new technology, at least a dozen countries are interested in developing their own vaccines to prepare for the next pandemic https://t.co/ym4QJQ4adX ...
Valneva(VALN) - 2025 Q2 - Earnings Call Presentation
2025-08-12 13:00
Financial Performance - H1 2025 - Total revenues reached €97.6 million, representing a 38% year-over-year growth[10] - Product sales amounted to €91 million, driven by IXIARO®/JESPECT®, DUKORAL®, and IXCHIQ®[62] - IXCHIQ® sales showed significant growth, increasing by 688% to €7.5 million[62] - The company experienced a significant reduction in operating cash burn, targeting a 50% reduction compared to 2024[10] - Adjusted EBITDA was a loss of €6.0 million[64] Product Performance - H1 2025 - IXIARO®/JESPECT® sales increased by 30.6% to €54.7 million[62] - DUKORAL® sales increased by 16.4% to €17.4 million, including €1.1 million from doses supplied to Mayotte[62, 63] - Third-party product sales increased by 8.8% to €11.4 million[62] Financial Outlook - 2025 - The company projects product sales between €170 million and €180 million[70] - Total revenues are expected to be in the range of €180 million to €190 million[70] - R&D expenses are projected to be between €90 million and €100 million, partially offset by grant funding and R&D tax credits[70]
Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates
GlobeNewswire News Room· 2025-08-12 05:00
Core Viewpoint - Valneva SE reported strong financial results for the first half of 2025, with total revenues of €97.6 million, a 37.8% increase compared to the same period in 2024, while confirming its financial guidance for the year [5][6][28]. Financial Performance - Total revenues reached €97.6 million in H1 2025, up from €70.8 million in H1 2024, marking a 37.8% increase [6][28]. - Product sales amounted to €91.0 million, a 33.3% increase from €68.3 million in H1 2024 [6][10]. - The company reported a net loss of €20.8 million in H1 2025, compared to a net profit of €34.0 million in H1 2024, which included a one-time gain from the sale of a Priority Review Voucher [6][38]. - Cash and cash equivalents stood at €161.3 million as of June 30, 2025, slightly down from €168.3 million at the end of 2024 [43]. R&D and Regulatory Updates - Valneva is focused on the Phase 3 data readout for its Lyme disease vaccine candidate, VLA15, which is in collaboration with Pfizer [3][19]. - The company has made significant progress in clinical and regulatory areas, including the launch of IXCHIQ® in response to a chikungunya outbreak [7][15]. - IXCHIQ® sales increased to €7.5 million in H1 2025, compared to €1.0 million in H1 2024, benefiting from supply to La Réunion [16][17]. Commercial Developments - Valneva finalized a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][13]. - An exclusive agreement was signed with CSL Seqirus for the marketing and distribution of Valneva's vaccines in Germany [11]. - The company expects product sales to grow to €170-180 million in 2025, contributing to positive cash flow [6][40]. Cost Management - Operating cash burn was significantly reduced to €10.9 million in H1 2025 from €66.3 million in H1 2024, reflecting improved sales and cost management [6][40]. - Research and development expenses increased to €32.4 million in H1 2025, driven by costs related to the Shigella vaccine candidate [32].
Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights
Globenewswire· 2025-08-11 20:15
Core Insights - Tonix Pharmaceuticals is anticipating FDA approval for TNX-102SL for fibromyalgia by August 15, 2025, which would mark the first new drug for this condition in over 16 years [1][2] - The company reported a cash position of $125.3 million as of June 30, 2025, which is expected to fund operations into the third quarter of 2026 [1][8][9] - Recent Phase 3 trial results for TNX-102SL demonstrated statistically significant pain reduction in fibromyalgia patients, supporting the ongoing New Drug Application (NDA) review [5][10] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company focused on developing therapies for pain management and vaccines for public health challenges, with a strong emphasis on central nervous system disorders [15] - The company has a diverse pipeline, including TNX-102SL for fibromyalgia and acute stress reactions, TNX-1500 for organ transplant rejection, and TNX-801 as a vaccine candidate [15][6] Financial Performance - For the second quarter of 2025, Tonix reported net product revenue of approximately $2.0 million, a slight decrease from $2.2 million in the same period of 2024 [10] - Research and development expenses increased to $10.8 million in Q2 2025 from $9.7 million in Q2 2024, primarily due to heightened clinical and manufacturing costs [11] - Selling, general, and administrative expenses rose significantly to $16.2 million in Q2 2025, compared to $7.5 million in Q2 2024, reflecting increased spending on pre-launch activities for TNX-102SL [12] Pipeline Developments - The company is advancing TNX-102SL for acute stress reaction and acute stress disorder, with the first patient dosed in the OASIS trial funded by the U.S. Department of Defense [4][15] - TNX-1500 has shown positive Phase 1 results and is being prepared for a Phase 2 study targeting kidney transplant rejection [6] - TNX-801 has demonstrated durable protection in animal models against mpox and rabbitpox, supporting its potential as a vaccine candidate [6] Market Position - In June 2025, Tonix was added to the Russell 3000® and Russell 2000® Indexes, enhancing its visibility among institutional investors as it approaches key regulatory milestones [1][13]
Dynavax (DVAX) Q2 Revenue Jumps 29%
The Motley Fool· 2025-08-07 21:25
Core Insights - Dynavax Technologies reported strong Q2 2025 results, with GAAP revenue of $95.4 million, exceeding analyst expectations of $86.7 million, and GAAP diluted EPS of $0.14, surpassing the consensus estimate of $0.10, indicating significant year-over-year growth [1][2][5] Financial Performance - GAAP revenue increased by 29.3% year-over-year from $73.8 million in Q2 2024 to $95.4 million in Q2 2025 [2] - Diluted EPS rose by 75% from $0.08 in Q2 2024 to $0.14 in Q2 2025 [2] - Adjusted EBITDA improved to $37.3 million in Q2 2025, up 81.9% from $20.5 million in Q2 2024 [2] - HEPLISAV-B net product revenue reached $91.9 million, a 30.8% increase from $70.2 million in Q2 2024 [2] Market Position and Strategy - Dynavax's HEPLISAV-B vaccine captured approximately 45% of the U.S. market share, up from 42% a year earlier, with a long-term goal of achieving at least 60% market share by 2030 [5][6] - The company focuses on expanding HEPLISAV-B's market share, advancing its vaccine pipeline, and forming partnerships for commercialization and research [4][11] Clinical Pipeline Progress - Significant advancements were reported in the clinical pipeline, including the shingles vaccine candidate Z-1018, which completed enrollment for a Phase 1/2 trial [7] - The plague vaccine program, in collaboration with the U.S. Department of Defense, is set to advance to Phase 2 trials in the second half of 2025, supported by a $30 million collaboration [7] Financial Guidance - For fiscal 2025, Dynavax raised its HEPLISAV-B net product revenue guidance to a range of $315–$325 million, with a target of at least $75 million in adjusted EBITDA [12] Cash Position and Expenses - As of June 30, 2025, the company had $613.7 million in cash and marketable securities, down from $713.8 million at the end of 2024, primarily due to a $200 million share repurchase program [9][13] - R&D expenses increased by 10.7% to $16.6 million, while SG&A expenses rose by 20.9% to $50.4 million in Q2 2025 compared to the same period in 2024 [9][13]
‘Sad day for science’: Doctor calls vaccine funding cut a ‘tragic mistake’
MSNBC· 2025-08-06 15:24
A major change in US health policy this morning. Health and Human Services Secretary Robert F. Kennedy Jr.. announcing he will shift nearly $500 million of federal funding away from the development of MN mRNA technology based vaccines. Now Kennedy is a longtime vaccine skeptic. He's already gutted a vaccine advisory committee.He's cut billions to state health agencies and canceled an ad campaign for the flu shot. Here's what he says about this latest decision. After reviewing the science and consulting top ...
X @The Wall Street Journal
The Department of Health and Human Services is winding down its mRNA vaccine development activities. The move includes terminating 22 vaccine investments and canceling and shrinking various contracts and solicitations. https://t.co/GxGGXCF08K ...
Tonix Pharmaceuticals Announces Presentation of New Data on Mpox and Smallpox Vaccine Candidate TNX-801 at the Vaccine Congress 2025
Globenewswire· 2025-07-10 11:00
Core Insights - Tonix Pharmaceuticals Holding Corp. presented new findings on TNX-801, a recombinant horsepox live virus vaccine, demonstrating its potential for durable immunity against mpox and smallpox with significantly reduced virulence compared to traditional vaccines [1][2][3] Group 1: TNX-801 Vaccine Development - TNX-801 is shown to be up to 100,000-fold less virulent than live smallpox vaccine strains, providing robust immunogenicity and protection for over one year in animal studies [1][2] - Subcutaneous administration of TNX-801 offers equivalent protection to traditional percutaneous methods, potentially reducing risks of administration-site infections and scarring [2][3] - Preclinical studies indicate that a single dose of TNX-801 generates strong antibody responses across various animal models, including immunocompromised subjects, with all vaccinated macaques surviving lethal mpox challenges [2][3] Group 2: Strategic Importance and Future Directions - The vaccine's unique risk-benefit profile may make it a critical tool for public health, particularly in response to mpox outbreaks and potential smallpox threats [2][3] - Tonix Pharmaceuticals aims to advance TNX-801 into clinical evaluation, focusing on subcutaneous delivery to streamline vaccination processes [2][3] - The ongoing classification of mpox as a public health concern by organizations like the WHO and CDC underscores the importance of developing effective vaccines like TNX-801 [3] Group 3: Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, for marketing authorization [4] - Tonix's infectious disease portfolio includes TNX-801 and TNX-4200, the latter being a broad-spectrum antiviral agent with a contract worth up to $34 million from the U.S. Department of Defense [4]
X @Bloomberg
Bloomberg· 2025-07-01 17:50
Ghana plans to ask India for support to develop a vaccine hub when Prime Minister Narendra Modi visits the West African nation this week https://t.co/c392lZq4ty ...
Tonix Pharmaceuticals Announces Oral Presentation and Panel Participation at the World Vaccine Congress Washington 2025
Newsfilter· 2025-04-16 11:00
Core Insights - Tonix Pharmaceuticals will present at the World Vaccine Congress Washington 2025, focusing on a novel mpox vaccine and leading a panel discussion on vaccine development and biosecurity policy [1][2][3] Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, and has received Fast Track designation from the FDA [4] - Tonix's CNS portfolio includes TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [4] - The infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. DoD [4] Upcoming Events - The oral presentation will be led by Dr. Farooq Nasar on April 23, 2025, at 10:10 a.m., discussing a single-dose mpox vaccine [2] - A panel discussion moderated by Dr. Zeil Rosenberg will take place on the same day at 3:25 p.m., addressing mpox and smallpox threats [3]