Tempero Bio Secures $70 Million Series B Financing to Advance TMP-301 into Phase 2 Trials for Substance Use Disorders

• Funding will support two Phase 2 clinical trials in alcohol and cocaine use disorders
• Company has initiated Phase 2 study in alcohol use disorder and plans to initiate cocaine studies over the next year
• John Wagner M.D., Ph.D. to join as Chief Medical Officer

OAKLAND, Calif., March 24, 2025 /PRNewswire/ -- Tempero Bio, Inc., a clinical-stage biopharmaceutical company developing transformative treatments for substance use disorders, today announced the closing of a $70 million Series B financing. The financing was led by 8VC with participation from Aditum Bio, Khosla Ventures, and other investors. The proceeds will be used to advance TMP-301 through two Phase 2 clinical trials for alcohol use disorder and cocaine use disorder, as well as Phase 3-enabling activities and preclinical studies for additional indications and formulations.

"Substance use disorders affect 48 million Americans and contribute to more than 100,000 deaths per year. We urgently need more effective treatments to help patients and families with these diseases," said Ricardo Dolmetsch, Ph.D., President and Chief Scientific Officer of Tempero Bio. "TMP-301 is a novel therapy that helps prevent relapse by targeting the underlying biology of addiction. This financing will allow us to advance TMP-301 through key proof of concept phase 2 studies in humans."

TMP-301 for Substance Use Disorders

TMP-301 is a next-generation metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM) designed to address neurobiological basis of addiction. It has shown promising results in preclinical models of alcohol, cocaine and opiate use disorders. TMP-301 has been evaluated in over 80 healthy volunteers in the Phase 1 setting with an acceptable safety and tolerability profile and has demonstrated robust receptor occupancy via positron emission tomography (PET) imaging.

Advancing Clinical Development

Tempero Bio has initiated two clinical studies to support TMP-301's development:

• A Phase 2 trial evaluating TMP-301's efficacy and safety in patients with alcohol use disorder.
  
  
• A drug-drug interaction (DDI) study assessing TMP-301 in individuals using cocaine. Research was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number U01DA057118.
  
  
• A Phase 2 study in cocaine use disorder is planned following the completion of the DDI study.

Addressing the Growing Addiction Crisis

The addiction crisis remains a significant public health challenge. The 2023 National Survey on Drug Use and Health reported that:

• 28 million Americans suffer from alcohol use disorder.
  
  
• 29 million Americans have a drug use disorder, with 7 million meeting criteria for both.
  
  
• 1.3 million Americans have cocaine use disorder, with no FDA-approved medications available.

Despite these staggering numbers, nearly 13 million people sought treatment in 2023, reflecting the strong demand for better therapeutic options. Our mission is to provide better treatments for these patients.

John Wagner M.D., Ph.D. to join as Chief Medical Officer 

Dr. John Wagner will be joining Tempero Bio as Chief Medical Officer. Dr. Wagner brings more than 20 years of drug development experience to his role, having successfully led over 150 first-in-human clinical trials and playing a pivotal role in bringing multiple blockbuster therapies to the market. Before joining Tempero Bio, Dr. Wagner served as Chief Medical Officer at Koneksa Health and Cygnal Therapeutics, held senior leadership positions at Takeda and Merck, and was a venture partner at Foresite Capital. Additionally, he currently serves as Editor-in-Chief of Clinical and Translational Science and holds an executive committee position with the Foundation for the National Institutes of Health Biomarkers Consortium.

About Tempero Bio

Tempero Bio is a clinical-stage biopharmaceutical company committed to developing innovative treatments for substance use disorders—chronic, relapsing brain diseases with limited pharmacologic solutions. The company is dedicated to advancing science-driven therapies that redefine treatment paradigms. Tempero Bio is an Aditum Bio portfolio company. For more information, visit www.temperobio.com.

About Aditum Bio

Aditum Bio accelerates the development of high-impact therapies by in-licensing promising drug candidates, forming dedicated companies, and advancing them through clinical trials. Aditum Bio focuses on disease mechanisms where innovation can significantly improve public health. For more information, visit www.aditumbio.com.

SOURCE Tempero Bio