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The pivotal OnWARD™ Phase 3 trial of AD04 for the remedy of alcohol-related disorders is nearing completion; on track to report the effects of Phase 3 in the current quarter
Ended the first quarter with money and money equivalents of $12. 7 million
CHARLOTTESVILLE, Va. , May 16, 2022 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company targeting the progression of treatments for the remedy and prevention of substance abuse and similar disorders, today provided an update on its business and reported its monetary effects for the first quarter of 2022.
William Stilley, Chief Executive Officer of Adial, said: “As previously reported, we completed the last patient stop in the pivotal OnWARD™ Phase 3 trial for AD04 for the treatment of alcohol use disorder (AUD) in the first quarter of 2022. , exceeding our pre-registration goals. We have now also completed the mandatory monitoring of the protection protocol, and are actively addressing other trial closure procedures similar to our clinical sites and statistical analysis. We are still on track to release the first effects this quarter, assuming there are no unforeseen delays with the remaining activities or the compilation of statistical knowledge. Overall, we are very encouraged by the trial perspective based on previous Phase 2b knowledge, as well as existing blind protection knowledge and trial retention rates. who recommend a well-tolerated therapy.
Mr. Stilley continued: “We ended the first quarter of 2022 with over $12 million in cash and cash equivalents. As a result, we are well-funded to advance partnership discussions, as well as mandatory regulatory and other steps as we prepare for AD04’s potential commercialization. AUD is the leading cause of death among other people aged 15-49 and has a potential market of $36 billion in the United States alone, with an estimated 35 million other people suffering from AUD. We believe that the prospective number of patients is even higher in Europe, where we are concluding the existing phase 3 trial. In particular, Europe has the highest per capita alcohol consumption in the world with around 55 million people with AUD. Unfortunately, there are limited features for AUD patients due to the significant effects of traditional remedies and the fact that those remedies have been largely ineffective. In contrast, AD04 appears to be well tolerated and is designed for simple handling as an oral tablet. Additionally, our other significant genetic screening will be a vital tool in helping to de-stigmatize this devastating disease and inspire patients to try treatment and continue treatment once started. We also see massive prospects for AD04 in other similar indications, such as opioid use disorders.
“Along with the ONWARD trial, we are also advancing the systems that evolved on our adenosine platform, through our wholly owned subsidiary, Purnovate, Inc. Preclinical knowledge has been encouraging for a variety of prospective indications such as pain, asthma, diabetes, womb and cancer, and we announced collaborations to expand treatments with global adenosine experts at the University of Virginia for burn/wound healing, and the University of California, San Diego for inflammatory bowel diseases and infectious diseases. We look forward to advancing Purnovate compounds in clinical trials next year and plans to actively pursue new potential partnerships to successfully and cost-effectively advance clinical trials and maximize prospective publicity for those assets.
Monetary results for the first quarter of 2022
Cash Position: As of March 31, 2022, money and money equivalents were $12. 7 million, to $6. 1 million as of December 31, 2021.
Research and progression expenses decreased from $1. 5 million to $0. 6 million in the first quarter of 2022, to $2. 1 million in the first quarter of 2021. This reduction is due to reduced costs similar to our trial from Phase 3 ONWARDS as it neared completion.
General and administrative expenses decreased by $0. 3 million to $2. 4 million in the first quarter of 2022, to $2. 8 million in the first quarter of 2021.
Net loss of $2. 9 million for the first quarter of 2022, compared to a net loss of $4. 8 million in the first quarter of 2021. Net loss consistent with a consistent percentage for the first quarter of 2022 $0. 13, compared to a net loss of $0. 30 consistent with a consistent percentage in the first quarter of 2021.
Other highlights
Adial has won acceptance of its U. S. patent. In the U. S. for the treatment of opioid use disorder, using AD04. This patent application covers the treatment of patients with an express genetic biomarker for the serotonin-3 receptor.
Purnovate announced positive in vivo knowledge for PNV-5032, as a possible remedy for asthma. PNV-5032 demonstrated significant inhibition of pulmonary flow resistance, which is a measure of asthmatic response, in an in vivo model.
Purnovate has signed a study collaboration agreement with the University of California, San Diego, to make a further comparison of the company’s proprietary adenosine analogues as a potential remedy for inflammatory diseases, in addition to inflammatory bowel disease and infectious diseases.
Adial held an assembly and was in communication with the Finnish Medicines Agency (FIMEA) regarding the finalization of the statistical research plan and protocol for the ONWARD trial. FIMEA was selected by the company as the main regulatory company of ONWARD due to its AUD table. As stated above, endpoint number one is relief in the number of days of binge drinking in the last two months of the trial compared to baseline. Secondary endpoints come with relief in total alcohol intake and course of depression measured through the Patient Health Questionnaire-9, a widely accepted tool for measuring depression. The Company has submitted an amendment to the protocol to comply with FIMEA guidelines.
In 2021, Adial won its first patent for genetic verification of patient identity for the AD04 remedy. This verification is expected to be a “supplemental diagnostic verification,” meaning it would get approval at the same time as AD04, assuming it is approved, and would also be a means of benefit to the Company. As stated above, the global prospective check market in the U. S. The U. S. exceeds $80 billion.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on emerging addiction remedies. The company’s lead investigational new drug, AD04, is a genetically targeted serotonin-3 receptor antagonist, a curative agent for the remedy of alcohol use disorder (AUD) and is recently under investigation. a study in the company’s pivotal Phase 3 ONWARD™ clinical trial for the prospective treatment of AUD in subjects with certain target genotypes, who deserve to be known by the company’s other uniquely significant diagnostic genetic test. A Phase 2b clinical trial of AD04 for the AUD remedy showed promising effects in reducing frequency of drinking, amount of drinking, and binge drinking (all statistically significant), and no problems with overt protection (no statistically significant serious adverse effects). occasions were reported). AD04 is also believed to have the potential to treat other addictive disorders, such as opioid use disorder, gambling, and obesity. The Company also develops adenosine analogs for the treatment of pain and other disorders through its wholly owned subsidiary, Purnovate, Inc. Additional information is available at www. adial. com.
About Purnovate, Inc.
Purnovate, Inc. , a wholly owned subsidiary of Adial Pharmaceuticals, Inc. , is a chemical and pharmaceutical development company focused on the invention and development of selective, potent, solid and soluble adenosine receptors to treat diseases and disorders such as the pain. . , asthma, cancer, diabetes, non-alcoholic steatohepatitis (NASH), and inflammatory diseases and disorders such as burns/wound healing, inflammatory bowel disorders, and infectious diseases.
Forward-Looking Statements
This release includes certain “forward-looking statements” within the meaning of United States federal securities laws. These statements are based on various facts and are derived using a large number of vital assumptions and are subject to known and unknown risks, uncertainties and other things that could cause actual effects, functionality or achievements to differ materially from the effects, functionality or expressed. or implicit in the long term in the achievements. through such forward-thinking companies. Sentences preceded, followed or otherwise come with the words “believes”, “expects”, “anticipates”, “intends”, “projects”, “estimates”, “plans” and similar expressions or long-term or conditional verbs like “will”, “deserve to”, “would”, “might” and “might” sometimes have a prospective nature and not an ancient fact, although not all prospective verbs come with the former. s come with s related to staying on track to report most sensitive effects of pivotal Phase 3 ONWARD™ trial for AD04 this quarter, trial outlook suggests well-tolerated therapy, AUD represents $36 billion market in US alone United States with 35 million other people suffering from AUD, with a potential number of patients even higher in Europe, with Europe having 55 million other people with AUD, AD04 appears to be well tolerated, and the company’s additional genetic screening is a tool vital to help de-stigmatize AUD and inspire patients back to check and continue treatment once started, prospect of AD04 in other similar indications, advancement of Purnovate compounds into clinical trials next year, look for new prospective partnerships to advance clinical trials in an efficient and cost-effective manner and maximize prospective advertising of Purno’s assets vate, the company’s patent for the verification of the genetic identity of patients for the AD04 remedy that received approval at the same time as AD04 and was a means of benefit for the company, being the potential global market for the test in the United States more than $80 billion and the prospect of AD04 to treat other addictive disorders such as opioid use disorder, gambling and obesity. All future visions contained in this document reflect our existing ideals and involve certain dangers and uncertainties, including, among other things, our ability to complete clinical trials on time and to achieve desired effects and benefits as expected, our ability to achieve regulatory approvals for the advertising of product applicants or to comply with ongoing regulatory requirements, regulatory limitations on our ability to advertise or advertise our product applicants for express indications, market acceptance of the applicants for our products and the successful progression, advertising or sale of our products, our ability to maintain our license agreements, the continued maintenance and expansion of our patent assets, our ability to identify and maintain collaborations, our ability to d charging or maintaining capital or mandatory subsidies to finance our studies and progression activities, and our ability to maintain our worker codes or maintain our listing on Nasdaq. These dangers should not be construed as exhaustive and are worth reading in conjunction with the other warnings included in our Annual Report on Form 10-K for the year ended December 31, 2021, upcoming Quarterly Reports on Form 10-Q, and existing reports. on Form 8-K filed with the Securities and Exchange Commission. Any prospect speaks only from the date it was first made. We undertake no legal responsibility to publicly update or revise any Prospective Array, whether as a result of new information, long-term events, superseded cases, or otherwise, unless required by law.
Contact: Crescendo Communications, LLC David Waldman / Natalya Rudman Tel. : 212-671-1021 Email: adil@crescendo-ir. com