Latest news with #RenovaHealth
Associated Press
08-05-2025
- Business
- Associated Press
TNF Pharmaceuticals and Renova Health Report Positive Results in Identifying Targets for Treating TNF-Driven Inflammation in Patients Receiving GLP-1 Agonists
BALTIMORE--(BUSINESS WIRE)--May 8, 2025-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) ('TNF' or the 'Company'), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health, a company committed to focusing on outpatient care to minimize costs, impact and the need for hospitalization, today announced positive results from the first stage of a general practice population study focusing on patients receiving GLP-1 agonists. The study series is expected to evaluate the impact of the Company's novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management in patients who are a) on GLP-1 agonists, b) candidates for treatment with GLP-1 agonists, or c) probably not suitable for treatment with weight loss therapy. In coordination with Renova Health, the purpose of this first stage was to analyze 30,000 patients already under the care of primary care physicians and identify convergences between the use of GLP-1 agonists and chronic disorders linked with increased risk of inflammation. The data were parsed into three cohorts depending on prespecified criteria. TNF plans to use these data to optimize appropriate patient recruitment and accelerate isomyosamine drug development. TNF's President and Chief Medical Officer, Mitchell Glass, M.D., commented, 'Our goal for our GLP-1 study series is to identify patients who are taking GLP-1 agonists to test whether isomyosamine can decrease inflammation and prevent or ameliorate the risk of adverse outcomes such as muscle wasting in patients who have baseline TNF-derived inflammatory signals. In our initial review of the data, we have already noted that sarcopenia and frailty are both underreported, which we believe provides evidence that at-risk populations could suffer adverse events from GLP-1 treatment without adequate surveillance to detect and treat drug-induced muscle wasting.' 'The prevalence of certain disorders such as sarcopenia were well below the Centers for Disease Control and Prevention's estimates in community dwelling adults,' said Dave Jacobs, Chief Executive Officer of Renova Health. 'Identifying patients in the community who are at increased risk of fall may enable us to use non-invasive monitoring to identify these patients earlier and more accurately and to provide support. We believe early and ongoing evaluation of sarcopenic and frail patients could enable us to impact quality of life in thousands of patients once identified and followed with straightforward and validated tests of balance and cognition.' About Renova Health Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health's success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit About Isomyosamine Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company's second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'may,' 'plan,' 'will,' 'would'' and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company's goals and expectations related to the Company's partnership with Renova Health. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company's ability to maintain compliance with the Nasdaq Stock Market's listing standards; the timing of, and the Company's ability to, obtain and maintain regulatory approvals for clinical trials of the Company's pharmaceutical candidates; the timing and results of the Company's planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company's ability to retain and attract senior management and other key employees; the Company's ability to quickly and effectively respond to new technological developments; and the Company's ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company's proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on CONTACT: Investor Contact: Robert Schatz (646) 421-9523 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MARYLAND INDUSTRY KEYWORD: RESEARCH TECHNOLOGY CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ARTIFICIAL INTELLIGENCE OTHER SCIENCE SOURCE: TNF Pharmaceuticals, Inc. Copyright Business Wire 2025. PUB: 05/08/2025 09:20 AM/DISC: 05/08/2025 09:19 AM
Business Wire
08-05-2025
- Business
- Business Wire
TNF Pharmaceuticals and Renova Health Report Positive Results in Identifying Targets for Treating TNF-Driven Inflammation in Patients Receiving GLP-1 Agonists
BALTIMORE--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) ('TNF' or the 'Company'), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health, a company committed to focusing on outpatient care to minimize costs, impact and the need for hospitalization, today announced positive results from the first stage of a general practice population study focusing on patients receiving GLP-1 agonists. The study series is expected to evaluate the impact of the Company's novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management in patients who are a) on GLP-1 agonists, b) candidates for treatment with GLP-1 agonists, or c) probably not suitable for treatment with weight loss therapy. In coordination with Renova Health, the purpose of this first stage was to analyze 30,000 patients already under the care of primary care physicians and identify convergences between the use of GLP-1 agonists and chronic disorders linked with increased risk of inflammation. The data were parsed into three cohorts depending on prespecified criteria. TNF plans to use these data to optimize appropriate patient recruitment and accelerate isomyosamine drug development. TNF's President and Chief Medical Officer, Mitchell Glass, M.D., commented, 'Our goal for our GLP-1 study series is to identify patients who are taking GLP-1 agonists to test whether isomyosamine can decrease inflammation and prevent or ameliorate the risk of adverse outcomes such as muscle wasting in patients who have baseline TNF-derived inflammatory signals. In our initial review of the data, we have already noted that sarcopenia and frailty are both underreported, which we believe provides evidence that at-risk populations could suffer adverse events from GLP-1 treatment without adequate surveillance to detect and treat drug-induced muscle wasting.' 'The prevalence of certain disorders such as sarcopenia were well below the Centers for Disease Control and Prevention's estimates in community dwelling adults,' said Dave Jacobs, Chief Executive Officer of Renova Health. 'Identifying patients in the community who are at increased risk of fall may enable us to use non-invasive monitoring to identify these patients earlier and more accurately and to provide support. We believe early and ongoing evaluation of sarcopenic and frail patients could enable us to impact quality of life in thousands of patients once identified and followed with straightforward and validated tests of balance and cognition.' About Renova Health Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health's success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit About Isomyosamine Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company's second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'may,' 'plan,' 'will,' 'would'' and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company's goals and expectations related to the Company's partnership with Renova Health. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company's ability to maintain compliance with the Nasdaq Stock Market's listing standards; the timing of, and the Company's ability to, obtain and maintain regulatory approvals for clinical trials of the Company's pharmaceutical candidates; the timing and results of the Company's planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company's ability to retain and attract senior management and other key employees; the Company's ability to quickly and effectively respond to new technological developments; and the Company's ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company's proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Business Wire
22-04-2025
- Business
- Business Wire
TNF Pharmaceuticals and Renova Health Utilize AI to Accelerate Drug Development
BALTIMORE--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) ('TNF' or the 'Company'), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health announce the application of AI and machine learning technologies to identify high-risk patient groups that may benefit the most from interventions that preserve lean muscle mass during GLP-1 treatment for diabetes, weight loss, and chronic weight management. In keeping with FDA's recent draft Guidance on using Artificial Intelligence, the TNF-Renova partnership is analyzing data from 30,000 patients to identify high-risk patients. TNF plans to use these data to optimize appropriate patient recruitment, accelerating isomyosamine drug development. 'Our collaboration partner, Renova Health has used its AI and machine learning technology platform to analyze and identify optimal patient pools and study sites, enabling a swift and efficient progression of our study series over the coming months,' said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. 'This technology has allowed us to look at the constellation of underlying conditions, symptoms, acute events, and medications being taken across thousands of patients to identify specific patient subsets for which isomyosamine treatment may be most beneficial.' Renova Health's proprietary AI and machine learning technology—including a cutting-edge natural language processing (NLP) and large language model (LLM) platform—offers key benefits to TNF Pharmaceuticals including the ability to quickly review thousands of patient records to identify a target population that may benefit from isomyosamine. This target population consists of patients who have underlying chronic diseases, such as diabetes, COPD, chronic kidney disease, or sarcopenia/frailty, have suffered an acute medical event associated with inflammation (such as a fall or bone fracture), and are taking GLP-1 medications. 'We are thrilled to collaborate with TNF Pharmaceuticals to advance precision medicine through our cutting-edge NLP, LLM, and AI platform,' said David Jacobs, CEO of Renova Health. 'Our technology transcends traditional big data analytics by creating highly specific patient personas, identifying optimal cohorts for isomyosamine based on underlying conditions, acute events, and medication profiles. Furthermore, our platform uncovers the nuanced impact of individual physician practices—such as varying diagnosis codes for GLP-1 prescriptions, like BMI versus diabetes—which can significantly influence cohort selection and study outcomes. This unparalleled precision enables TNF Pharmaceuticals to target patients who stand to benefit most, accelerating study timelines and enhancing therapeutic impact.' About Renova Health Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health's success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit About Isomyosamine Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company's second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'may,' 'plan,' 'will,' 'would'' and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company's goals and expectations related to TNF-Renova partnership. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company's ability to maintain compliance with the Nasdaq Stock Market's listing standards; the timing of, and the Company's ability to, obtain and maintain regulatory approvals for clinical trials of the Company's pharmaceutical candidates; the timing and results of the Company's planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company's ability to retain and attract senior management and other key employees; the Company's ability to quickly and effectively respond to new technological developments; and the Company's ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company's proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Yahoo
22-04-2025
- Business
- Yahoo
TNF Pharmaceuticals and Renova Health Utilize AI to Accelerate Drug Development
Machine learning technology used to identify patients for studies of muscle mass preservation during GLP-1 treatment BALTIMORE, April 22, 2025--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) ("TNF" or the "Company"), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health announce the application of AI and machine learning technologies to identify high-risk patient groups that may benefit the most from interventions that preserve lean muscle mass during GLP-1 treatment for diabetes, weight loss, and chronic weight management. In keeping with FDA's recent draft Guidance on using Artificial Intelligence, the TNF-Renova partnership is analyzing data from 30,000 patients to identify high-risk patients. TNF plans to use these data to optimize appropriate patient recruitment, accelerating isomyosamine drug development. "Our collaboration partner, Renova Health has used its AI and machine learning technology platform to analyze and identify optimal patient pools and study sites, enabling a swift and efficient progression of our study series over the coming months," said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. "This technology has allowed us to look at the constellation of underlying conditions, symptoms, acute events, and medications being taken across thousands of patients to identify specific patient subsets for which isomyosamine treatment may be most beneficial." Renova Health's proprietary AI and machine learning technology—including a cutting-edge natural language processing (NLP) and large language model (LLM) platform—offers key benefits to TNF Pharmaceuticals including the ability to quickly review thousands of patient records to identify a target population that may benefit from isomyosamine. This target population consists of patients who have underlying chronic diseases, such as diabetes, COPD, chronic kidney disease, or sarcopenia/frailty, have suffered an acute medical event associated with inflammation (such as a fall or bone fracture), and are taking GLP-1 medications. "We are thrilled to collaborate with TNF Pharmaceuticals to advance precision medicine through our cutting-edge NLP, LLM, and AI platform," said David Jacobs, CEO of Renova Health. "Our technology transcends traditional big data analytics by creating highly specific patient personas, identifying optimal cohorts for isomyosamine based on underlying conditions, acute events, and medication profiles. Furthermore, our platform uncovers the nuanced impact of individual physician practices—such as varying diagnosis codes for GLP-1 prescriptions, like BMI versus diabetes—which can significantly influence cohort selection and study outcomes. This unparalleled precision enables TNF Pharmaceuticals to target patients who stand to benefit most, accelerating study timelines and enhancing therapeutic impact." About Renova Health Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health's success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit About Isomyosamine Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company's second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company's goals and expectations related to TNF-Renova partnership. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company's ability to maintain compliance with the Nasdaq Stock Market's listing standards; the timing of, and the Company's ability to, obtain and maintain regulatory approvals for clinical trials of the Company's pharmaceutical candidates; the timing and results of the Company's planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company's ability to retain and attract senior management and other key employees; the Company's ability to quickly and effectively respond to new technological developments; and the Company's ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company's proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on Contacts Investor Contact: Robert Schatz(646) 421-9523rschatz@ Sign in to access your portfolio
Yahoo
29-01-2025
- Business
- Yahoo
TNF Pharmaceuticals Launches Study Series Aimed at Preserving Lean Muscle Mass During GLP-1 Weight Loss Treatment
Series of studies to observe signals of inflammation and TNF-alpha levels in patients taking GLP-1s including Wegovy® or Ozempic® Lean body mass accounts for up to 40% of weight loss from GLP-1 treatments Potential entry into high growth GLP-1 market of nearly $50 billion in 2024, projected value of $100 billion by 2029 BALTIMORE, January 29, 2025--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) ("TNF" or the "Company"), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced that it has initiated the first in a series of studies to evaluate the impact of its novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management. "The body of evidence for the GLP-1 drug class shows that up to 40% of total weight loss in GLP-1 patients is lean body mass including skeletal muscle mass,1" said Mitchell Glass, M.D., President and Chief Medical Officer of TNF. "The purpose of our clinical study series is to assess isomyosamine's potential to preserve lean muscle mass during and following GLP-1 weight loss in chronic overweight and obese patients of all age groups." The first study examines TNF-α levels in patients receiving the GLP-1 agonist Wegovy® or Ozempic® who show signs of increased inflammation associated with sarcopenia, which is the progressive loss of muscle mass. Isomyosamine targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia. "Findings from the initial observational study will inform our forward move into multiple planned clinical studies designed to evaluate isomyosamine's effects in our target population of GLP-1 patients," Dr. Glass continued. "Our collaboration partner, Renova Health, is using its proprietary AI and machine learning technology to analyze and identify optimal patient pools and study sites, enabling an efficient progression of our study series over the coming months." "We are proud to partner with TNF to tackle the critical challenges faced by patients using GLP-1 medications," said David Jacobs, Chief Executive Officer of Renova Health. "This collaboration is expected to allow us to leverage our advanced AI and machine learning capabilities for precise cohort selection and patient engagement, enabling us to uncover deeper, more meaningful patient insights that will enhance the study's impact." Valued at $49.3 billion in 2024,2 the GLP-1 receptor agonist market is projected to reach $105 billion in 2029, growing at a projected compound annual growth rate (CAGR) of 19.2% from 2023 to 2029.3 According to the Centers for Disease Control and Prevention, obesity costs the U.S. healthcare system nearly $173 billion annually.4 About Isomyosamine Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company's second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company's ability to launch, the success and timing of, the Company's planned trial of isomyosamine (MYMD-1®) as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company's ability to maintain compliance with the Nasdaq Stock Market's listing standards; the timing of, and the Company's ability to, obtain and maintain regulatory approvals for clinical trials of the Company's pharmaceutical candidates; the timing and results of the Company's planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company's ability to retain and attract senior management and other key employees; the Company's ability to quickly and effectively respond to new technological developments; and the Company's ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company's proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise. ____________________________1 Drug Discovery and Development, March 20242 Research and Markets, GLP-1 Market: Industry Trends and Global Forecasts to 2035…., August 20243 Global Data, March 20244 Centers for Disease Control and Prevention (CDC), About Obesity, January 2024 View source version on Contacts Investor Contact: Robert Schatz(646) 421-9523rschatz@
