Phoenix PharmaLabs, Inc.

Studies Conducted at University of Oklahoma Health Sciences Center and Florida Atlantic University Under Grant from U.S. Department of Defense Showed Drug Reduced Stress and Alcohol Consumption in in Vivo Studies WOODS CROSS, Utah--(BUSINESS WIRE)--Phoenix PharmaLabs, Inc. ( ), a private company developing potent, non-addictive treatments for pain and substance abuse disorders, today announced that in vivo studies demonstrated that the company’s lead compound, PPL-138, reduced symptoms of PTSD and decreased alcohol consumption in a rat model of PTSD/AUD (alcohol abuse disorder). The work conducted at University of Oklahoma Health Sciences Center and Florida Atlantic University under a grant from the US Department of Defense (DoD), funded through the Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (PASA)*, demonstrates that PPL-138 may have potential to be an effective treatment for these common comorbid disorders. Dr. Andrea Cippitelli in the Department of Biomedical Science, Charles E. Schmidt College of Medicine, is the principal investigator of the grant. Dr. Cippitelli has been examining the ability of the drug to reduce alcohol consumption in anxiety-susceptible or anxiety-resistant PTSD subjects. “When modeling PTSD in animals, it is important to take into consideration that trauma induces PTSD in only a portion of individuals and anxiety can be a trigger for increased alcohol consumption,” noted Dr. Cippitelli. Dr. Kelly Standifer, Professor and Chair of the Department of Pharmaceutical Sciences, College of Pharmacy and Richard T. Anderson Chair in Neuroscience is the principal investigator for the OUHSC arm of the study that exams the ability of this novel compound to alleviate pain and anxiety-like symptoms associated with PTSD over time. “We chose this model of PTSD because it produces a wide range of comorbidities experienced by those diagnosed with PTSD. It’s exciting that something non-addictive appears to reduce pain, anxiety-like behaviors and alcohol consumption so effectively,” Dr. Standifer said. A patent application for the Use of PPL-138 for treatment of PTSD/AUD has just been This new indication for PPL-138 is in addition to patents already granted or currently filed for the compound’s use in treatment of acute/chronic pain and substance abuse disorders. Dr. Lawrence Toll, Professor, Biomedical Science at Schmidt College of Medicine at Florida Atlantic University and FAU Stiles-Nicholson Brain Institute Investigator, who also serves as Phoenix’s Chief Neuropharmacologist, coordinated the studies and serves as a co-investigator for the project. “We continue to be impressed with the ability of PPL-138 to provide potential therapeutic benefits in the areas of pain, substance abuse, as well as this new indication for PTSD,” Dr. Toll said. “We are moving forward in our development of PPL-138 for safe, potent, non-addictive treatment for moderate to severe acute and chronic pain,” said William Crossman, president and CEO of Phoenix PharmaLabs. “The additional research and development of PPL-138 for other indications provides the company with new avenues for potential licensing and revenue streams. More immediately, it enables us to utilize grants that can further develop the compound for these additional indications.” Crossman added that the company is in the midst of its final pre-clinical studies to enable it to seek IND approval from the FDA to initiate human clinical trials. Phoenix has been the recipient of more than $12 million in grants from governmental entities such as NIDA and the US Army to develop treatments to address critical unmet needs: Safe, potent, non-addictive relief of moderate to severe pain Treatment for various types of addiction Treatment for PTSD/AUD Phoenix PharmaLabs is a preclinical drug discovery company. In addition to the company’s lead compound, PPL-138, Phoenix has a portfolio of 25 other compounds that have the potential to treat pain, substance abuse and addiction. The company has funded its efforts through grants as well as more than $6 million of private funding. The company currently has a $3 million convertible note offering of which $1 million has already been raised. *The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Alcohol and Substance Abuse Research Program under Award No. W81XWH-18-2-0044. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. In conducting research using animals, the investigator(s) adhered to the laws of the United States and regulations of the Department of Agriculture.

WOODS CROSS, Utah--(BUSINESS WIRE)-- Phoenix PharmaLabs, Inc., ( ), a private company developing potent, non-addictive treatments for pain and addiction, today announced the receipt of an $8.7 million grant from the National Institute on Drug Abuse (NIDA). The primary focus of the grant is to study the company’s lead compound, PPL-138, for the treatment of cocaine use disorder (CUD). The grant has been awarded as part of NIH’s HEAL – The Helping to End Addiction Long-Term® Initiative. This trans-agency effort is working to speed scientific solutions to stem the national public health crisis. Funding from the grant will support the cost of advancing PPL-138 through its remaining preclinical studies and through Phase 1 human clinical trials. PPL-138 is one of a portfolio of compounds licensed by Phoenix that have the potential to treat severe acute and chronic pain without the threat of addiction. In addition, PPL-138 has demonstrated in preclinical studies that it can reduce self-administration and relapse of cocaine in rats. Cocaine is a Schedule II drug, indicating high potential for abuse, but a doctor may administer the drug for legitimate medical needs. Unfortunately, it has gained a reputation as an illicit recreational drug. Currently there are no medications approved by the FDA to treat cocaine use disorder. The problem is significant: In 2020, approximately 1.3 million individuals aged 12 or older had a cocaine use disorder in the previous 12 months. (Source: 2020 National Survey on Drug Use and Health. ). Also, in 2020, 19,447 individuals died from an overdose that involved cocaine. “This marks a milestone for Phoenix in that it is the largest grant ever awarded to the company,” said William Crossman, company president. “It is a tremendous recognition of our work in this area, and we look forward to furthering our research toward this additional indication for PPL-138.” PPL-138 is one of a portfolio of 20-plus novel compounds licensed to Phoenix initially developed in a collaboration between the company’s Chief Neuropharmacologist, Dr. Larry Toll, with Dr. Stephen Husbands, a colleague at the University of Bath. PPL-138 has NOP/mu partial agonist activity and has been demonstrated to have efficacy for treatment of both pain and cocaine use disorder in preclinical models. In the spirit of a public/private partnership, Phoenix is currently raising an additional $3 million in investment funding to supplement the grant monies to cover expenses (e.g., overhead) not specifically covered by the NIDA grant. The grant funding is not dependent upon this private investment; Phoenix has already received the first tranche of funding from NIDA. Phoenix PharmaLabs is a preclinical drug discovery company. In addition to the company’s PPL-138, the company also has a portfolio of other compounds that have the potential to treat pain and abuse and addiction. The company has funded its efforts through grants that have totaled more than $3 million plus more than $5 million of private funding, including two over-subscribed Reg CF offerings that raised more than $2 million dollars.