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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 or email Dawn Halkuff, head of Investor Relations at [email protected]. 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 or email Dawn Halkuff, head of Investor Relations at [email protected]. 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Company also provides updates on its Phase 2 RECONNOITER Study in Raynaud's Phenomenon and Systemic Sclerosis and other corporate activities BOSTON, Sept. 9, 2024 /PRNewswire/ -- Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AISA-021(cilnidipine), a fourth-generation calcium channel antagonist. Aisa is developing AISA-021 for the treatment of Systemic Sclerosis (SSc), a rare disease, which impacts approximately 175,000 Americans and has the highest mortality rate of any autoimmune disease. Continue Reading "To our knowledge, this is the first time the FDA has granted orphan drug designation to a calcium channel antagonist for an autoimmune illness," said Andrew Sternlicht, MD, CEO and Founder of Aisa Pharma. "We hope this designation will accelerate our development program for AISA-021, which is designed to provide a once-daily, well-tolerated, and economical treatment that we hope can improve the lives of patients with SSc. We are actively seeking a development partner and investors to support bringing this much-needed treatment to patients." AISA Pharma receives FDA orphan drug designation for their new drug treatment for Systemic Sclerosis Post this Under the FDA's Orphan Drug Act, orphan drug status provides incentives, including tax credits, grants and waiver of certain administrative fees for clinical trials, and seven years of market exclusivity following drug approval. To be granted the orphan drug designation, FDA concludes that it is medically plausible that the treatment may improve the disease. Aisa submitted information from the ongoing Phase 2 study demonstrating improvement on several endpoints versus placebo, including SSc symptoms of overall disease severity, disease-related pain, gastrointestinal dysfunction, skin ulcers, disability, and breathing symptoms, as well as Raynaud's symptoms. In a preliminary review by an independent data safety committee, the ongoing study of 60 patients demonstrated a much lower incidence and severity of side effects as well as improved efficacy for preventing Raynaud's attacks, when compared to published reviews of current therapies. Aisa also provided the following corporate updates: A Pre-IND meeting with the FDA for AISA-021 in the treatment of Systemic Sclerosis and Secondary Raynaud's Phenomenon is scheduled for September 2024. The initial drug screening performed by the NIH as part of the Preclinical Pain Screening Platform to evaluate the suitability of AISA-021 as a non-opioid analgesic, demonstrated no abuse liability or addictive potential for the drug. Additional results are pending. Two abstracts on AISA-021 will be presented at the ACR Convergence Scientific Meeting in Washington DC on 11/16/2024: AISA 021, a Novel Calcium Channel Antagonist in Development for Raynaud's & Systemic Sclerosis, Has Activity at Sodium Channel Targets for Pain Relief and Treats Scleroderma Pain Better Than Current Calcium Channel Blockers in a Phase 2A StudyPreliminary Results from the RECONNOITER Trial, a Phase 2 Study of AISA 021 in the Treatment of Secondary Raynaud's, Primarily Due to Systemic Sclerosis About AISA-021: AISA-021 is a form of cilnidipine, a fourth-generation calcium channel blocker (CCB), distinguished from other dihydropyridine CCBs by its increased selectivity for the N-type calcium channel. Cilnidipine is approved in certain Asian countries and widely used to treat hypertension there, but was never approved in the US, Canada, EU and UK. Cilnidipine causes vasodilation and further improves function in the heart, kidney and vasculature. In robust studies of hypertension treatment, cilnidipine is better tolerated with a wider therapeutic window than other approved CCBs, which are used off-label for Raynaud's. Unlike other approved CCBs, AISA-021 may also have a role in treating pain. About Systemic Sclerosis and Raynaud's Phenomenon in Systemic Sclerosis: Systemic Sclerosis (SSc) is the most fatal of autoimmune illnesses and affects approximately 175,000 patients in the United States. Approximately half of patients die of the disease within 12 years from initial diagnosis and 95% of SSc patients experience Raynaud's symptoms, which they describe as their most debilitating symptom. Raynaud's Phenomenon is characterized by decreased blood flow which can cause severe pain and tingling in the hands and fingers. Cardiac, renal and vascular disease, which have been shown to improve in patients treated for hypertension, contribute to morbidity and mortality in patients with SSc. No drug has been approved anywhere in the world for the treatment of Raynaud's. About Aisa Pharma Inc. Aisa is a private biopharmaceutical company in Boston, MA, founded in 2019. For additional information: [email protected]; SOURCE Aisa Pharma