Adial Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update
- Positive feedback from US and EU regulatory meetings
- Strategic decision to focus on obtaining FDA approval
- Confirmation of primary endpoint based on PNHDD
- Planning to conduct two Phase 3 trials with AD04
- Confident in AD04's ability to address a $40 billion market
- Sale of Purnovate business reduces cash burn rate
- None.
Reported Positive Feedback from US and EU Regulatory Meetings
Sale of Purnovate Significantly Reduces Cash Burn Rate
Charlottesville, Va., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the second quarter of 2023.
Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We continue to advance AD04 to meaningful inflection points and recently received favorable feedback from our US and EU regulatory meetings. Following the feedback, we made a strategic decision to focus our efforts on obtaining FDA approval, as the US standard should translate to acceptance in other international markets. In addition, the FDA confirmed the primary endpoint based on Percentage of No Heavy Drinking Days (PNHDD)-patients who reduced their alcohol consumption to zero heavy drinking days in the last two months of a six-month study. Furthermore, the FDA acknowledged that our post hoc analysis showing a statistically and clinical meaningful effect in specific genetic subtypes was positive and promising but requested additional data to support an NDA submission. As a result, we are currently planning to conduct two Phase 3 trials with AD04 in parallel to support potential approval in the shortest timeframe possible. Toward this end, and now having received regulatory feedback, we are progressing our partnering discussions and intend to provide further updates as appropriate. Overall, we remain confident in AD04’s ability to address a significant unmet need for patients suffering from alcohol use disorder, representing an addressable market of approximately
Other Recent Developments
Purnovate
On May 16, 2023, Adovate, LLC, exercised its option for the purchase of the assets and business of the Company’s wholly owned subsidiary, Purnovate, Inc. The Option Agreement provides that the parties will enter into a final acquisition agreement for the sale of the Purnovate assets under previously agreed financial terms. Adovate was recently formed by William Stilley, co-founder and former CEO of Adial, for the sole purpose of acquiring, funding and advancing the Purnovate assets.
Adial received an upfront payment of
The transaction was independently evaluated and unanimously approved, first by the Adial Audit Committee of the Board of Directors, and then by its full Board of Directors, with Mr. Stilley, a current board member, abstaining from the vote.
Second Quarter 2023 Financial Results
- Cash Position: As of June 30, 2023, cash and cash equivalents were
$1.2 million compared to$4.0 million as of December 31, 2022. The Company believes that its existing cash and cash equivalents, as well as the impact of the agreement to sell its Purnovate’s Assets and Business, will fund its operating expenses into the first quarter of 2024. Under the agreement, the Company received non-dilutive funding and the sale has significantly reduced its current cash burn rate. - Research and Development expenses decreased by
$250 thousand (37% ) in the three months ended June 30, 2023 compared to the three months ended June 30, 2022. This decrease was driven partly by a reduction of approximately$96 thousand in direct development costs of AD04 as trial activities, which were winding down in the second quarter of 2022, were no longer taking place in the second quarter of 2023, replaced by less expensive regulatory consultations and data analysis. In addition, a one-time accrual of$155 thousand for a royalty due the University of Virginia Patent Foundation took place in the second quarter of 2022. - General and Administration expenses decreased by
$1.5 million (59% ) in the three months ended June 30, 2023 compared to the three months ended June 30, 2022. This decrease was primarily due to expense reductions of approximately$0.9 million and lower equity compensation expense of approximately$0.4 million , which were due to reduced bonus payments and headcount. - Net Income was
$1.1 million for the three months ended June 30, 2023, compared to a net loss of$3.8 million for the three months ended June 30, 2022. Net Income for the second quarter of 2023 included a gain of$2.66 million as a result of the Purnovate Sale.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. The Company is also developing adenosine analogs for the treatment of pain and other disorders. Additional information is available at www.adial.com.
Forward Looking Statements
This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding FDA approval translating to acceptance in other international markets, plans to conduct two Phase 3 trials with AD04 in parallel to support potential approval in the shortest timeframe possible, progressing with partnering discussions and providing further updates as appropriate, AD04’s ability to address a significant unmet need for patients suffering from alcohol use disorder, representing an addressable market of approximately
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