WARREN, N.J., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today highlights emerging scientific evidence linking persistent viral reservoirs to Long COVID, and emphasizes the potential of its investigational precision T cell therapy, TVGN 489, for the treatment of this debilitating condition which affects an estimated 20 million Americans and represents an area of unmet need. Peer-reviewed studies such as the ones published in Sci Trans Med, Clin Mic ...

Core Insights - Tevogen Bio Holdings Inc. expresses gratitude to the U.S. Department of Health and Human Services for addressing Long COVID through roundtables focused on patient experiences and research [1] - Approximately 20 million adults in the U.S. are affected by Long COVID, leading to significant economic consequences due to workforce absenteeism and productivity losses [2] - Tevogen's investigational drug, TVGN 489, shows promising results in clinical trials and may play a crucial role in addressing the Long COVID public health crisis [3] Company Developments - The CEO of Tevogen emphasizes the importance of addressing the lasting consequences of SARS-CoV-2, highlighting the potential of TVGN 489 to restore health for those affected by Long COVID [4] - Tevogen is committed to developing accessible and affordable personalized therapeutics through its ExacTcell™ platform, which focuses on precision T cell therapies [4]

Core Insights - Traws Pharma is advancing its antiviral programs targeting respiratory viruses, particularly focusing on ratutrelvir for COVID-19 and Tivoxavir marboxil (TXM) for influenza, in response to ongoing health threats and the need for effective treatments [1][20] - The company has submitted a Phase 2 study for ratutrelvir to evaluate its efficacy against PAXLOVID in newly diagnosed COVID patients, with results expected by the end of 2025 [3][5] - TXM is being positioned for stockpiling readiness, with ongoing discussions with BARDA for inclusion in pandemic preparedness initiatives [2][5] Product Development - Ratutrelvir is a ritonavir-free oral protease inhibitor designed for once-daily dosing over 10 days, showing promising Phase 1 results with plasma drug levels maintained significantly above the effective concentration [5][15] - TXM is an investigational single-dose treatment for bird flu and seasonal influenza, demonstrating strong preclinical efficacy against H5N1 and good tolerability in animal models [5][16] - The U.S. market opportunity for both products is estimated to be multi-billion dollars, driven by the ongoing need for effective antiviral treatments [5][15][16] Financial Performance - For Q2 2025, Traws reported revenue of $2.7 million, a significant increase from $57,000 in the same period in 2024, primarily due to deferred revenue recognition from a terminated licensing agreement [11][27] - Research and development expenses decreased to $2.3 million from $4.0 million year-over-year, reflecting a strategic shift in focus towards virology programs [12][13] - The net loss for Q2 2025 was $0.9 million, a substantial improvement compared to a net loss of $123.1 million in Q2 2024, which included a one-time charge related to an acquisition [13][29] Management and Corporate Updates - Traws will host a business update call on August 14, 2025, to discuss its Q2 results and pipeline progress [8] - Recent management changes include the appointment of Jack Stover as Chairman of the Board and Charles Parker as Interim CFO [13][21] - The company is actively seeking partnerships for its legacy oncology programs, including rigosertib and narazaciclib, to support further development [21]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had a cash balance of approximately $3.8 million [20] - For the three months ended June 30, 2025, consolidated operating expenses were approximately $1.8 million, down roughly $800,000 or 32% from $2.6 million a year ago [20][21] - The operating loss decreased to $1.8 million compared to $2.6 million from the previous year, reflecting progress in aligning resources with strategic priorities [21] Business Line Data and Key Metrics Changes - The company advanced its lead oncology indication clinical program and delivered preclinical results supporting broader applications, including long COVID, while significantly reducing operating expenses [7] - The first cohort of the Australian oncology trial completed Hemopurifier treatments without any device deficiencies or immediate complications [10] - An independent data safety monitoring board recommended advancing to the second treatment cohort after reviewing safety data from the first cohort [11] Market Data and Key Metrics Changes - The Australian oncology trial is designed to include patients on either monotherapy or combination therapy, increasing the potential pool of patients for the study [12] - The global economic burden of long COVID is approximately $1 trillion per year, indicating a large unmet medical need [15] Company Strategy and Development Direction - The company decided not to proceed with the India study to focus resources on the Australian trial, which is seen as the fastest track toward regulatory approval [7][8] - The focus remains on moving the Hemopurifier towards regulatory approval and expanding its use across multiple diseases [7] Management Comments on Operating Environment and Future Outlook - Management acknowledged the need to continue raising funds for clinical research, ideally through strategic partnerships rather than financial investors [31] - The decision to halt the Indian trial was primarily strategic, aimed at avoiding potential delays in moving forward to the PMA phase [31][34] Other Important Information - The company presented preclinical data on long COVID at a symposium, indicating the potential for the Hemopurifier to remove extracellular vesicles associated with long COVID [15][16] - The company is actively recruiting additional sites in Australia to speed up patient enrollment for the clinical trial [42] Q&A Session Summary Question: Is the primary endpoint of the Australian study safety, and is the company on track to meet it? - Management confirmed that the first cohort has been treated without adverse events, indicating progress towards meeting the primary endpoint [25][26] Question: How does the preclinical data translate to actual patient treatment? - Management acknowledged that lab results may not directly reflect patient outcomes, emphasizing the importance of data from actual patients [27][28] Question: What are the implications of not moving forward with the Indian trial? - Management stated that the decision was strategic to avoid delays in regulatory approval, although cost savings were also a factor [30][31][34] Question: Will the company be able to speed up enrollment in the Australian trial? - Management confirmed efforts to speed up enrollment, including recruiting additional sites and using clinical trial liaisons and social media campaigns [41][42]

Core Insights - Invivyd, Inc. has announced the addition of Dr. Akiko Iwasaki to the SPEAR Study Group, which focuses on the biology and clinical implications of persistent SARS-CoV-2 spike antigen [1][2] - The SPEAR Study Group aims to assess the safety and exploratory efficacy of monoclonal antibodies in individuals suffering from Long COVID and COVID-19 Post-Vaccination Syndrome (PVS) [3][4] Company Developments - Dr. Iwasaki is recognized for her research on viral pathogenesis and post-viral chronic conditions, including Long COVID, and leads several studies related to these areas [2] - The SPEAR Study Group was established in response to reports suggesting symptom improvement in Long COVID patients following administration of PEMGARDA, a monoclonal antibody authorized for emergency use [3][4] - Invivyd is utilizing monoclonal antibody technology to provide therapeutic options for individuals affected by Long COVID and PVS [3][4] Product Information - PEMGARDA (pemivibart) is an investigational monoclonal antibody with demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants [5][6] - VYD2311 is a novel monoclonal antibody candidate being developed to address the urgent need for new COVID-19 prophylactic and therapeutic options [11][12] - Both PEMGARDA and VYD2311 are engineered to target the SARS-CoV-2 spike protein, aiming to inhibit virus attachment to human cells [5][12]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had a cash balance of approximately $5.5 million [16] - Operating expenses for the year were approximately $9.3 million, a reduction of about $3.3 million or 26% compared to the prior year [17] - A noncash charge of $4.6 million was recognized related to a warrant inducement offer made in March 2025 [17] - The company recorded approximately $324,000 in other income related to the employee retention tax credit under the CARES Act [18] Business Line Data and Key Metrics Changes - The company treated the first three patients in its oncology trial using the Hemopurifier at clinical sites in Australia [6] - Regulatory approval was received in India to initiate a similar oncology study [12] - The trial protocol was expanded to align with evolving standards of care in immunotherapy [6] Market Data and Key Metrics Changes - The collaboration with UCSF on long COVID research is ongoing, with findings to be presented at the upcoming Keystone Symposium [14] - The economic burden of long COVID is estimated to impact 44 to 48 million people in the US [15] Company Strategy and Development Direction - The primary focus remains on oncology, with ongoing trials in Australia and India [22] - The company aims to streamline operations and reduce costs while focusing resources on areas with the greatest clinical and regulatory impact [15] - Future exploration of the Hemopurifier in addressing long COVID is being considered, but oncology remains the main priority [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in clinical and laboratory settings, noting it as the most significant advancement since joining the company [16] - The company is preparing for potential partnerships and government grants to support ongoing research and development [57] Other Important Information - The company plans to file its annual report on Form 10-K following the call and will hold its next earnings call in August 2025 [19] Q&A Session Summary Question: What are the focus areas for the company? - The focus remains primarily on oncology, with the upcoming trial in India being parallel to the Australian trial [22][24] Question: What is the expected timeline for delivering more robust data from the Australian trial? - Preliminary data from the first cohort is expected in about three months, with a data safety monitoring board meeting set for July [28][29] Question: Are there any nonrecurring costs expected in the future? - Management does not anticipate additional nonrecurring expenses following the termination of senior executives [32][33] Question: How quickly can patient recruitment be expected in India? - Recruitment in India may proceed faster than one patient per month, depending on oncologists' comfort levels [66][68] Question: What is the landscape for grant approvals currently? - The company is familiar with the grant process and is open to pursuing grants that align with its goals, though the current environment may present challenges [72][74] Question: What is the current expense run rate? - The company is operating at a level that is necessary to continue operations, with potential increases in expenses as clinical activities ramp up [76][78]

Core Insights - Aethlon Medical, Inc. is presenting research on the Hemopurifier® device's ability to bind extracellular vesicles (EVs) in Long COVID samples at an upcoming symposium [1][6] - Long COVID affects an estimated 44 to 48 million people in the U.S., with a significant economic burden projected at $2 billion for those experiencing symptoms for a year [2] - The Hemopurifier is designed to remove harmful EVs from the blood, which are implicated in the pathogenesis of Long COVID [4][8] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an investigational device aimed at treating cancer and life-threatening infectious diseases [8] - The Hemopurifier has shown efficacy in removing life-threatening viruses and harmful EVs in pre-clinical studies [8] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [10] Research Details - The research presented will evaluate the binding of EVs from Long COVID patients to the Hemopurifier's affinity resin, which targets the sugar mannose [5][6] - The study involves collaboration with the University of California San Francisco Medical Center Long COVID clinic [5] - The poster presentation is scheduled for August 12, 2025, and will be available on Aethlon's corporate website afterward [6][7]

Core Viewpoint - Long COVID is increasingly recognized as a serious condition affecting millions, with no approved treatment options currently available, highlighting the urgent need for effective therapies [1][2][4] Group 1: Long COVID Overview - Long COVID impacts approximately 20 million adults in the U.S. and millions more globally, with 10-30% of COVID-19 patients experiencing lingering symptoms such as fatigue and cognitive impairment [2][5] - The economic impact of long COVID is significant, estimated at $3.7 trillion due to loss in quality of life, earnings, and increased medical costs [5] Group 2: Bezisterim Development - BioVie Inc. has initiated the Phase 2 ADDRESS-LC clinical trial to evaluate bezisterim (NE3107) for treating neurological symptoms associated with long COVID, with topline data expected in the first half of 2026 [1][3] - Bezisterim targets neuroinflammation, which is believed to play a central role in long COVID symptoms, and has shown potential in reducing chronic symptoms in trials for Alzheimer's and Parkinson's diseases [1][3][6] Group 3: Clinical Trial Details - The ADDRESS-LC study is a randomized, placebo-controlled trial involving approximately 200 patients with long COVID experiencing cognitive impairment and fatigue [3][8] - The trial is fully funded by a $13.13 million grant from the U.S. Department of Defense [10] Group 4: Mechanism of Action - Bezisterim is an orally bioavailable, blood-brain barrier-permeable compound that modulates inflammatory pathways implicated in chronic inflammation, potentially improving symptoms in long COVID patients [6][8] - The drug is designed to reduce neuroinflammation and address metabolic dysfunction, which may help restore normal function and improve quality of life for affected individuals [3][4] Group 5: Broader Implications - The persistent presence of SARS-CoV-2 proteins and the resulting inflammatory pathways are linked to prolonged neuroinflammation and symptoms in long COVID patients, indicating a need for targeted interventions [4][8] - BioVie is also conducting trials for bezisterim in Parkinson's and Alzheimer's diseases, demonstrating its broader therapeutic potential [7][9]