Adial Pharmaceuticals, Inc. Stock

Greetings. Welcome to Adial Pharmaceuticals Acquisition of Azora Therapeutics Conference Call. [Operator Instructions] Please be advised this conference is being recorded for replay purposes. There will not be a question-and-answer session. I will now turn the conference over to Mike Moyer of LifeSci Advisors. Thank you. You may begin.

Thank you, operator, and good morning, everyone. This morning, Adial Pharmaceuticals issued a press release announcing its acquisition of Azora Therapeutics, a concurrent private placement financing of up to $64 million and updates to the leadership team. This release is available at www.adial.com under the Investors and News Events section.

A recording of this call will also be available on the Investors and News Events tab of Adial's website for 30 days. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements. These include, but are not limited to, statements regarding the expected effects and perceived benefits of the acquisition of Azora Therapeutics, the concurrent financing and use of proceeds, expectations regarding cash runway, further development plans for AT177, ongoing and planned clinical trials and expected data readouts and the potential benefits of the combined company's product candidates.

Such statements represent management's judgment as of today and involve assumptions, risks and uncertainties. Please refer to Adial Pharmaceuticals' most recent filings with the SEC available at sec.gov or on Adial's website for additional risks and uncertainties that could cause actual outcomes to differ materially from those contemplated in these forward-looking statements, including in our press releases issued this morning and on Form 8-K filed with the SEC.

Neither Adial nor Azora is under any obligation to update or revise any forward-looking statements, except as may be required by applicable securities laws. This communication is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities. It is now my pleasure to pass the call over to Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals.

Thank you, Mike, and good afternoon, everyone. Today marks an important milestone for Adial Pharmaceuticals. We are very pleased to announce our acquisition of Azora Therapeutics and a concurrent private placement of up to $64 million. This transformative transaction repositions Adial to pursue a compelling opportunity in ulcerative colitis.

Azora is a biopharmaceutical company developing treatments for serious inflammatory diseases. Spun out of Stanford University's Translational Medicine SPARK program, its lead asset, AT177, is a novel colon-targeted aryl hydrocarbon receptor agonist, or AhR agonist, designed to deliver localized AhR agonism in the colon with limited systemic exposure. We believe this differentiated approach has the potential to address a significant unmet need in ulcerative colitis.

Concurrent with the closing of the acquisition, we entered into a definitive agreement for a private investment in public equity, or PIPE, financing expected to result in gross proceeds of approximately $32 million before placement agent and other offering expenses. In conjunction, upon opening of an IND or first patient dosed, the company will be eligible to receive an additional $32 million.

The financing was led by Coastlands Capital with participation from Stonepine Capital Management, Boxer Capital Management, AuGC BioFund, along with other institutional investors, insiders and management. This level of support from leading health care investors underscores the conviction in Azora's science and the differentiated potential of the AT177 program. After underwriting and private placement fees, we expect that the total cash and the anticipated milestone payment alongside current cash held by Adial will position the combined company to advance AT177 through key preclinical and clinical milestones, including IND-enabling studies, Phase 1a and Phase 1b clinical studies in ulcerative colitis.

I want to thank our Board members, investors and both teams for their commitment throughout this process. It is now my pleasure to introduce Matt Davidson, PhD, who joins Adial as our newly appointed Chief Development Officer and as a member of our Board of Directors. Matt is the Co-Founder and former CEO of Azora Therapeutics and brings expertise in immunology and capital-efficient drug development.

Prior to co-founding Azora, he was the Founder and CEO of Verrica Pharmaceuticals, where he spearheaded the development of the first FDA-approved drug to treat the viral skin disease, molluscum contagiosum. We are excited to have him on board to help lead Adial in this next chapter. Matt?

Thank you, Cary. I'm thrilled to be here and to share the story of Azora with everyone. My drug development career has been inspired by looking for de-risked solutions to unmet medical needs. Azora's story was inspired by my co-founder, Julie Saiki's personal experience as a patient with ulcerative colitis and a motivation to create a desperately needed new therapy.

At Azora, we set out to build a differentiated company focused on the biology of immune regulation at the mucosal barrier, specifically the aryl hydrocarbon receptor or AhR pathway. Our story began with indigo naturalis, a botanical extract with demonstrated clinical benefit in ulcerative colitis, but with potential systemic safety liabilities.

When my co-founder, Julie, experienced that benefit firsthand as a patient, she and her team at Stanford tested it rigorously in the clinic with compelling and validating results. At Azora, we identified indirubin, the most potent AhR agonist within indigo naturalis, as the molecule responsible for efficacy. Localized AhR agonism plays a central role in maintaining the gut epithelium and regulating the colonic inflammation that drives ulcerative colitis.

That insight became the foundation for AT177, an oral, fully synthetic patented AhR agonist designed to liberate indirubin directly in the colon, capturing the benefit of indigo naturalis in a highly controlled oral dosage form with limited systemic exposure. We believe it has the potential to be a best-in-class treatment for ulcerative colitis. Although it has its own challenges as an uncontrolled botanical, long-term use of indigo naturalis has not been associated with an increased cancer risk, a reassuring signal for the biology we're building upon.

Recent clinical experience is a reminder that systemic approaches in ulcerative colitis can carry meaningful safety trade-offs. AT177 was engineered to concentrate activity in the colon where it counts, minimizing systemic exposure. The ulcerative colitis field has repeatedly confronted the same challenge, achieving high durable remission with a safe, effective oral drug. Many approved therapies require intravenous or subcutaneous administration, carry immunosuppressive burdens that can increase rates of infection and cancer and are still associated with low remission rates and loss of response over time.

AT177's oral dosage form and targeted colonic activity are designed to address these limitations. Our near-term development priorities are focused on moving AT177 efficiently through IND-enabling studies into Phase 1 safety and pharmacology studies, followed by a Phase 1b trial in patients with ulcerative colitis. Beyond AT177, we believe that our AhR agonist platform holds promise across a broad range of immune-mediated conditions, including other inflammatory bowel diseases.

We look forward to sharing more about those opportunities as the program advances. With that, I'll turn it back to Cary to walk through the structure of the acquisition and financing. Cary?

Thanks, Matt. As part of the transaction, the company is pleased to announce the appointment of Wendy Young, PhD, to its Board of Directors. Dr. Young brings more than 30 years of drug discovery and biopharma leadership experience, including senior leadership roles at Genentech, where she served as Senior Vice President, Small Molecule Drug Discovery. She currently serves as an adviser to Google Ventures and is an independent Board Director and scientific adviser to multiple life science companies. Dr. Young's deep expertise in small molecule drug discovery, company building and strategic R&D leadership will be highly valuable as we enter our next phase.

Now let me walk through the structure of the transaction. The acquisition of Azora was structured as a stock-for-stock transaction, pursuant to which all of Azora's outstanding equity interests were exchanged based on a fixed exchange ratio for a combination of 437,474 shares of Adial common stock and approximately 12,930 shares of Adial Series A nonvoting convertible preferred stock, which represents 12,930,617 shares on an as-converted-to-common basis.

In each case, this was calculated on a fully diluted basis and without giving effect to any beneficial ownership limitations. Please refer to the, About the Transactions section of the press release and the 8-K filed today with the SEC for a complete description of the terms. Concurrent with the acquisition, Adial entered into a definitive agreement for a concurrent private placement of up to $64 million in gross proceeds to Adial before deducting placement agent and other offering expenses.

The private placement is comprised of an initial upfront financing of approximately $32 million in gross proceeds in exchange for prefunded warrants to purchase 11,780,948 shares of Adial's common stock, representing a purchase price of $2.75 for each prefunded warrant sold at the initial closing and the potential for up to an additional milestone-dependent $32 million in gross proceeds in exchange for prefunded warrants to purchase up to 11,780,948 shares of common stock and common warrants to purchase up to 11,780,948 shares of common stock at a combined purchase price of $2.75 for each prefunded warrant and common warrants sold at the milestone closing.

The private placement is expected to close on June 12, subject to customary closing conditions. As a result of the transactions, following Adial's stockholder approval and without giving effect to the funding of the milestone tranche of the financing, equity holders of Adial immediately prior to the acquisition will own approximately 7.7% of Adial's common stock. Equity holders of Azora immediately prior to the acquisition will own approximately 51% of Adial's common stock and investors in the private placement financing, including the conversion of outstanding notes, will own approximately 41.3% of Adial's common stock.

In each case, this is calculated on a fully diluted as converted to common basis without giving effect to any beneficial ownership limitations using the treasury stock method and based on the implied equity values of Adial and Azora. The acquisition was approved by the Board of Directors of Adial and the Board of Directors and stockholders of Azora. Adial expects to use the proceeds from the private placement primarily to advance AT177 through key clinical milestones, including IND-enabling studies, Phase 1a and Phase 1b clinical studies.

We note that this description of the transactions is not complete. We refer investors and security holders to our filings with the SEC, which incorporate by reference the material agreements in connection with the acquisition and private placement. I will now turn the call back to Matt for closing remarks.

Thank you, Cary. We are genuinely excited about the opportunity to advance Azora's colon-targeted AhR agonist, AT177, to address a significant unmet need in ulcerative colitis. We look forward to sharing updates on our progress in the months ahead.

This will conclude today's conference. You may disconnect at this time, and thank you for your participation.