Proof‐of‐concept trial of PP‐01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder

NIH/NIDA funding will support a pivotal clinical program for an investigational treatment for adults with cannabis use disorder PHOENIXVILLE, Pa., Aug. 20, 2026 /PRNewswire/ -- PleoPharma, Inc., a clinical-stage development company focused on cannabis-related health issues, today announced the award of a $6.5 million, three-year grant from the National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH). The funding will support the advancement of the company's pivotal Phase 3 CAN-004 clinical trial of PP-01, an investigational treatment for cannabis withdrawal symptoms (CWS) in adults with cannabis use disorder (CUD). More than 19 million people in the United States were reported by SAMHSA to have CUD. Symptoms of withdrawal, including sleep problems, anxiety, irritability, restlessness, cravings, physical symptoms, and more, complicate efforts to quit and serve as a driver of relapse. Despite the scale of the problem, there are currently no FDA-approved pharmacologic treatments for cannabis withdrawal syndrome or cannabis use disorder. "Receiving this NIDA award is an important validation of the substantial unmet need for a treatment for cannabis use disorder and the potential of PP-01 to alleviate the withdrawal symptoms that can stand in the way of recovery," said Shelli Grahm, Ph.D., senior vice president - medical/clinical research. "This funding will help advance our pivotal Phase 3 program and build the clinical evidence needed to potentially bring a needed pharmacologic treatment option to adults living with CUD." PleoPharma has completed Phase 1 and Phase 2b studies of PP-01, and in the Phase 2b CAN-002 trial, the primary endpoint of mitigating cannabis withdrawal symptoms in participants with cannabis use disorder was achieved, demonstrating a dose response with no serious adverse events reported. Importantly, PP-01 received Fast Track designation from the U.S. Food and Drug Administration, underscoring the unmet need and seriousness of the condition. These successful results have paved the way for CAN-004, the ongoing pivotal Phase 3 trial, with the first patient dosed in June 2026. The study is evaluating the safety and efficacy of PP-01 in adults with moderate to severe CUD. "People with cannabis use disorder are in need of the same scientific rigor, medical attention and treatment innovation afforded to people living with other substance use disorders," said Ginger Constantine, co-founder, CEO and chairperson of the board at PleoPharma. "We are very grateful for NIDA's support as we work to advance a potential medication assisted treatment option that may help patients with cannabis dependence remain engaged in treatment and facilitate recovery." Research noted in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number 1U01DA0660079-1. About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is in Phase 3 and has the potential to be the first-in-class treatment to mitigate the withdrawal symptoms experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended as a once daily oral product with a rapid onset of action and excellent safety and tolerability. About PleoPharma PleoPharma, Inc. is a privately held clinical stage development company in addiction medicine focused on finding solutions for people suffering from cannabis addiction and other cannabis-related health problems. The PleoPharma team includes a world class team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma Inc., please visit www.PleoPharma.com or for media inquiries, please contact Brendi Bluitt at bbluitt@jpa.com. SOURCE PleoPharma, Inc See this Press Release on PR Newswire

Presentations will highlight the patient experience of cannabis withdrawal/cannabis use disorder and Phase 2 CAN-002 data for investigational PP-01 in adults with cannabis use disorder PHOENIXVILLE, Pa., June 15, 2026 /PRNewswire/ -- PleoPharma, a clinical-stage clinical development company focused on cannabis-related health issues, announced today that it will present two posters at the College on Problems of Drug Dependence (CPDD) 88th Annual Scientific Meeting, taking place June 13-17, 2026, in Portland, Oregon. Both posters will be presented on Monday, June 15, from 5-6:30 p.m. PT. The presentations will feature data on cannabis withdrawal in adults with cannabis use disorder (CUD), including findings from a qualitative patient-reported outcomes study and results from the Phase 2 CAN-002 clinical trial of PP-01, an investigational, once-daily oral PP-01 being evaluated for cannabis withdrawal in patients with CUD. There are currently no FDA-approved therapies for cannabis withdrawal or cannabis use disorder, representing a significant unmet medical need. Poster Presentations Poster 1: Results of a Qualitative Study of Patient Reported Outcomes of Cannabis Withdrawal Severity in Participants with Cannabis Use Disorder (Slagle et al.) This qualitative patient-reported outcomes study of 15 adults characterized the severity, onset, and impact of cannabis withdrawal in adults with CUD. The findings underscore the meaningful burden withdrawal symptoms can place on patients attempting to stop or reduce cannabis use. Ashley Slagle M.S., Ph.D., chief clinical outcome officer, consultant, said, "These findings provide important qualitative insight into the severity and speed of onset of cannabis withdrawal symptoms in individuals with cannabis use disorder. These data capture the patient voice directly, advancing a clearer understanding of the burden of cannabis withdrawal and the need for effective treatment options." Poster 2: PP-01 Mitigated Cannabis Withdrawal Symptoms of Irritability and Angry Outbursts in a Phase 2 Clinical Trial (McRae-Clark et al.) This poster presents results from the Phase 2 CAN-002 trial (NCT05494437), in which PP-01 HD produced a statistically significant 43% reduction in the Irritability Domain versus placebo (P = 0.01) during Days 2-5, with a dose response observed. Ginger Constantine, M.D., chief executive officer, co-founder and chairperson of the board of PleoPharma, said, "The CAN-002 findings add to the growing body of evidence supporting PP-01 and its potential role in addressing cannabis withdrawal symptoms in patients with cannabis use disorder. We are pleased to share these data at CPDD and remain focused on advancing a potential new treatment option in an area of substantial unmet medical need." PP-01 is currently being advanced as a potential first-in-class treatment for cannabis withdrawal symptoms associated with cannabis use disorder. About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is in Phase 3 and has the potential to be the first-in-class treatment to mitigate the withdrawal symptoms experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended as a once daily oral product with a rapid onset of action and excellent safety and tolerability. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in addiction medicine focused on finding solutions for people suffering from cannabis addiction and other cannabis-related health problems. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma Inc., please visit www.PleoPharma.com or for media inquiries, please contact Brendi Bluitt at bbluitt@jpa.com. SOURCE PleoPharma, Inc. See this Press Release on PR Newswire

Phase 3 trial initiation advances PP-01, an investigational, once-daily therapy for cannabis withdrawal symptoms in patients with cannabis use disorder Cannabis use disorder affects an estimated 20.6 million people in the U.S., underscoring the scale of this unmet medical need PHOENIXVILLE, Pa., June 18, 2026 /PRNewswire/ -- PleoPharma, Inc., a clinical-stage development company focused on cannabis-related health issues, today announced that the first patient has been dosed in CAN-004, a Phase 3 clinical trial evaluating PP-01, an investigational medication intended for the mitigation of cannabis withdrawal symptoms in adults with cannabis use disorder (CUD). This milestone marks the initiation of PleoPharma's pivotal Phase 3 program and represents a significant step toward addressing a critical unmet need for the millions of individuals affected by CUD. PP-01 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and has the potential to become the first approved treatment specifically designed to mitigate cannabis withdrawal symptoms. "Dosing the first patient in our Phase 3 trial is a significant milestone for PleoPharma and an important step forward to help those patients with cannabis use disorder who are seeking to quit or reduce cannabis," said Ginger Constantine, M.D., chief executive officer, co-founder and chairperson of the board of PleoPharma. "Despite the growing prevalence of cannabis use disorder, there are currently no FDA-approved treatments for cannabis withdrawal syndrome or cannabis use disorder." CAN-004 is a Phase 3, multicenter, randomized, double-blind, placebo and active-controlled study evaluating the efficacy and safety of PP-01 in adults with moderate to severe CUD who are seeking to discontinue cannabis use. The CAN-004 study build upon positive Phase 2b clinical data and is intended to support an FDA submission of a new drug application for PP-01. Additional information about CAN-004 (NCT07644052) is available at www.clinicaltrials.gov. About Cannabis Use Disorder Cannabis use disorder (CUD) is a chronic and increasingly prevalent condition that affects an estimated 20.6 million people in the United States1. More than 1.4 million people received treatment for CUD in 2024 despite the absence of an approved medication assisted treatment, underscoring the scale of the disease and the need for an effective treatment.1. Many people with CUD experience a rapid onset of withdrawal symptoms when they attempt to stop or reduce cannabis, leading to relapse. Typical symptoms include anxiety, irritability, cravings, sleep disturbance, decreased appetite, restlessness, depression, mood, and physical symptoms. About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is in Phase 3 and has the potential to be the first-in-class treatment to mitigate the withdrawal symptoms experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended as a once daily oral product with a rapid onset of action and excellent safety and tolerability. About PleoPharma, Inc. PleoPharma, Inc. is a privately held clinical stage development company in addiction medicine focused on finding solutions for people suffering from cannabis addiction and other cannabis-related health problems. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma Inc., please visit www.PleoPharma.com or for media inquiries, please contact Brendi Bluitt at bbluitt@jpa.com. Reference Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2024 National Survey on Drug Use and Health. HHS Publication No. PEP25-07-007. Rockville, MD: SAMHSA; 2025. SOURCE PleoPharma, Inc See this Press Release on PR Newswire

PHOENIXVILLE, Pa., March 30, 2026 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that management will present at the Centri Capital Conference in New York City on April 14, 2026 at 8:30 a.m. Eastern Time (ET). About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space focused on finding solutions for people suffering from cannabis addiction and other cannabis related health problems. PleoPharma's lead asset, PP-01, is entering Phase 3 clinical trials and is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The US Government reported that in 2024 ( samhsa.gov ) , ~20 million Americans had Cannabis Use Disorder. The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. The PleoPharma team includes a world class management team and board of directors who collectively have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. PleoPharma closed on a Series B financing round of $36M in the fall of 2025 and has raised over $60M since it was founded in 2019. For more information on PleoPharma Inc., please visit  www.PleoPharma.com  or email Jason Goodson, Chief Business Officer at  jgoodson@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. SOURCE PleoPharma, Inc See this Press Release on PR Newswire

Financing led by Biotech Specialist Funds and a Generalist with significant participation from Series A investors Proceeds will support the Phase 3 Program for patients with Cannabis Use Disorder Phoenixville, pa, October 21, 2025 – PleoPharma, Inc., a privately held company focused on finding treatments for cannabis-related health issues, announced today the closing of a $36MM Series B financing round. PleoPharma will use the proceeds to advance its lead asset, PP-01. This investigational product is currently the first, and only Fast Track-designated treatment for the mitigation of Cannabis Withdrawal in patients with Cannabis Use Disorder, which is now entering Phase 3. “Recent government data from SAMHSA reported that cannabis addiction continues to accelerate with over 20 million people reported to have Cannabis Use Disorder in the US, an underserved population with no effective or FDA approved solution. We are grateful to have the partnership of this incredible group of new and existing investors who share our commitment to deliver first in class treatments for those with cannabis addiction and withdrawal,” said Ginger Constantine MD, co-founder and CEO of PleoPharma, Inc.“ SuperVision Partners LLC served as the lead placement agent for the offering along with Castle Hill Capital Partners, Inc. About cannabis withdrawal/cannabis use disorder The US Government (SAMHSA) reported that in 2024, ~20.6 million Americans had cannabis use disorder. Between 2018 and 2023, the reported number of individuals who received treatment for cannabis-related health problems grew an average of 27% annually (samhsa.gov). People with cannabis use disorder commonly experience significant withdrawal symptoms for which there are currently no FDA approved medications. “We recognize that many people do use cannabis without becoming dependent”, said Ginger Constantine”, but as with alcohol, some may develop a dependence or use disorder that is worsened by withdrawal symptoms. Our mission is to provide a treatment option for those who want help discontinuing cannabis.” About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is entering Phase 3 and has the potential to be the first-in-class treatment to mitigate the withdrawal symptoms experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended as a once daily oral product with a rapid onset of action and excellent safety and tolerability. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space focused on finding solutions for people suffering from cannabis addiction and other cannabis-related health problems. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma Inc., please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. See this Press Release on PR Newswire

Positive Phase 2b Results from the CAN-002 Study of PP-01, an investigational product intended to mitigate Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder PHOENIXVILLE, Pa., June 19, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 2b multicenter, randomized, double-blind, multi-dose, placebo-controlled clinical trial of titrating doses of PP-01 for the mitigation of Cannabis Withdrawal Syndrome (CWS) in participants with Cannabis Use Disorder (CUD) at the 2025 annual meeting of The College on Problems of Drug Dependence in New Orleans, LA. PleoPharma, Inc. presented both a poster presentation "Predictors of Cannabis Abstinence in a Clinical Trial" on June 17, 2025 and an oral presentation "PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use" on June 18, 2025 from their Phase 2b study data.  This study evaluated the safety and effectiveness of PP-01, a novel once daily, oral, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. Adult treatment-seeking participants in the CAN-002 Study reported average baseline cannabis use of 4.6 grams/day and mean age of first use ~16.5 years (range 7 to 46). By DSM-5 criteria, 84% had severe CUD and 16% had moderate CUD. PP-01 significantly reduced Cannabis Withdrawal Scores compared to placebo (P value < 0.02). A secondary endpoint evaluated cannabis abstinence and PP-01 demonstrated 5-fold greater abstinence two weeks post-treatment compared to placebo.  Data also showed that reduction of cannabis withdrawal symptoms during the first week of treatment was predictive of abstinence. PP-01 was well tolerated. The most common adverse events were mild and included headache, somnolence, fatigue, nausea, and dizziness. There were no serious adverse events. "We are excited to be developing PP-01, which was granted Fast Track designation by the FDA, and has the potential to be the first FDA approved product to help people suffering from CWS with CUD, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023  ( samhsa.gov ) , ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit  www.PleoPharma.com  or email Dawn Halkuff, head of Investor Relations at  dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. SOURCE PleoPharma, Inc See this Press Release on PR Newswire

New Patent Issued on April 8, 2025 Patent Protection to March 2041 PHOENIXVILLE, Pa., April 16, 2025 /PRNewswire/ -- PleoPharma, Inc. ("PleoPharma" or the "Company"), a privately held company focused on Cannabis-related health issues, announced today that the U.S. Patent Office has issued a new patent focusing on the treatment of sleep disturbances, including sleep quality and duration, associated with cannabis withdrawal syndrome ("CWS") in patients with cannabis use disorder ("CUD"). " We are pleased to have received our third issued patent. Improving sleep quality, depth and duration for patients suffering from CWS is an important aspect of PP-01 and a tremendous benefit in quality of life, especially for CUD patients who are suffering from CWS," said PleoPharma's CEO, Ginger Constantine, MD. Recently issued U.S. Patent No. 12,268,659 , entitled "Methods and Compositions for Treating Cannabis Use Disorder and Mitigating Cannabinoid Withdrawal," contains method of use claims for mitigating CWS, and in particular improving sleep quality, depth and duration, and further claiming specific dose ranges and detailed dosing schedules corresponding to what the Company believes will be the dosing for PP-01.  The Company notes that additional patent applications are pending in the US and globally in which it is pursuing further IP development. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with ~ 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with Cannabis Use Disorder commonly experience significant withdrawal symptoms, known as Cannabis Withdrawal Syndrome, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. PleoPharma recognizes that many people do use cannabis responsibly, but as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. See this Press Release on PR Newswire

Pharmacodynamic Results from the CAN-001 Phase 1b Study of PP-01, an Investigational Product, intended to Mitigate Cannabis Withdrawal Syndrome PHOENIXVILLE, Pa., Nov. 18, 2024 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 1b Pharmacokinetic and Pharmacodynamic study of Cannabis Withdrawal Syndrome ("CWS") in participants with Cannabis Use Disorder ("CUD") at the annual meeting of the American Academy of Addiction Psychiatry (AAAP) in Naples, Fla. "We are pleased to present our proof-of-concept study that evaluated the safety and effectiveness of PP-01, a novel, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. We are excited to be developing PP-01 with the goal of being the first FDA approved product to help people suffering from CWS, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. Participants in the CAN-001 Study reported using an average of 3.5 ± 2.2 grams/day of cannabis with a mean age of first use 14 years (range 6 to 22). By DSM-5 criteria, 64% had severe CUD and 36% had moderate CUD. Compared to placebo, PP-01 administered once daily significantly reduced mean CWS ratings beginning 4 hours post first dose of PP-01 (first measured timepoint). This effect was sustained through Day 5 ( P  values < 0.0009; all timepoints). Participants experienced fewer cravings, better sleep and were also less bothered by their withdrawal symptoms when treated with PP-01 than with placebo ( P values < 0.007; all timepoints). PP-01 was well tolerated. There were no serious adverse events, and all adverse events in the PP-01 group were mild in severity. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire Click below to download a copy of the poster presented at the November 18, 2024 AAAP Meeting:

A POTENTIAL FIRST IN TREATMENT Fast Track Designation highlights the potential of PP-01 to address a serious and unmet need for patients with Cannabis Use Disorder Phase 3 Preparations Underway PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder.    "We are pleased that PP-01 has been granted Fast Track designation and are grateful to the FDA for recognizing the significance of cannabis withdrawal for the growing population with cannabis use disorder," said Ginger Constantine MD, CEO of PleoPharma. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier ( FDA.gov ).  In addition, a drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling and priority reviews. About cannabis withdrawal/cannabis use disorder The US Government (SAMHSA) reported that in 2023, ~19.2 million Americans had cannabis use disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The reported number of individuals who received treatment for cannabis related health problems has grown by an average of 27% annually from 2018 to 2023 ( samhsa.gov ) . People with cannabis use disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of either cannabis withdrawal syndrome or cannabis use disorder. "We recognize that many people do use cannabis without becoming dependent", said Ginger Constantine, "but as with alcohol, some may develop a dependence (use disorder) that may be sustained and worsened by withdrawal symptoms. Our mission is to provide a treatment option for those who want help discontinuing cannabis." About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is entering a Phase 3 clinical trial and has the potential to be the first-in-class treatment to mitigate the withdrawal syndrome experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended to be a once daily oral product with a rapid onset of action and an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space focused on finding solutions for people suffering from cannabis addiction and other cannabis related health problems. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma Inc., please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire

2nd Patent issued in September 2024 Patent Protection to March 2041 PHOENIXVILLE, Pa., Oct. 7, 2024 /PRNewswire/ -- PleoPharma, Inc. ("PleoPharma" or the "Company), a privately held company focused on Cannabis-related health issues, announced today that it has been issued two U.S. patents with broad claims relating to methods of treating cannabis withdrawal syndrome ("CWS"). " We are pleased to have received the issuance of our second patent following up on the success of our Phase 2b trial.  These U.S. patent issuances underscore the scientific achievements of PleoPharma and directly support the commercial value of our programs" said Ginger Constantine, CEO of PleoPharma.  "We are excited to be developing PP-01 with the goal of being the first approved product to help people suffering from CWS, a rapidly growing patient population". U.S. Patent 11,197,846  and  U.S. Patent 11,931,334 , both entitled "Methods and Compositions for Treating Cannabis Use Disorder and Mitigating Cannabinoid Withdrawal," contain method of use claims for mitigating CWS drawn to specific dose ranges and detailed dosing schedules corresponding to what the Company believes will be the dosing for PP-01.  The Company notes that additional patent applications are pending in the US and globally in which it is pursuing further IP development. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with Cannabis Use Disorder commonly experience significant withdrawal symptoms, known as Cannabis Withdrawal Syndrome, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. PleoPharma recognizes that many people do use cannabis responsibly, but as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit  www.PleoPharma.com  or email Dawn Halkuff, head of Investor Relations at  dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire

PHOENIXVILLE, Pa., Sept. 19, 2024 -- PleoPharma, Inc., a privately held company focused on cannabis related health issues, announced today that their CEO, Ginger Constantine, MD, presented at the Life Sciences PA's Life Sciences Future Conference. Dr. Constantine presented data from PleoPharma's Phase 1 and Phase 2b studies of PP-01, their lead drug candidate intended for the mitigation of Cannabis Withdrawal Syndrome. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who have received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with regular and dependent cannabis use commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. About PP-01 PP-01 has a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is an investigational product entering Phase 3 that is in development for the mitigation of symptoms related to cannabis withdrawal. PP-01 is intended to be a once daily oral product taken before bedtime providing rapid and sustained efficacy with an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset that is being developed as the first FDA approved treatment for mitigation of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder.The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com  or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire