AiPharma Enters into Strategic Alliance and Stock Swap Agreement with Appili Therapeutics

Rhea-AI Summary

AiPharma Global Holdings and Appili Therapeutics have announced a strategic alliance to advance the global development of Avigan®/Reeqonus™ (favipiravir), an oral antiviral under evaluation for COVID-19. Under this agreement, AiPharma will acquire approximately 19.4% of Appili's shares, while Appili will receive around 6% of AiPharma. With Avigan® authorized in nine countries and over 1.5 million patients treated in 2021, the partnership aims to enhance pandemic preparedness and expedite clinical advancements. Both companies will form a joint steering committee to oversee development and regulatory activities.

Positive

• Strategic alliance formed to develop Avigan®/Reeqonus™ for COVID-19 expansion.
• AiPharma will hold approximately 19.4% of Appili shares post-agreement.
• Avigan® has been authorized in 9 countries, with over $190 million in sales in 2021.

Negative

• The completion of the equity swap is contingent on Toronto Stock Exchange approval.
• Potential market uncertainties regarding further equity issuances.

DUBLIN, Sept. 29, 2021 /PRNewswire/ -- AiPharma Global Holdings LLC ("AiPharma"), a private biopharmaceutical research, development, and commercialization company, and Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) ("Appili"), a biopharmaceutical company focused on drug development for infectious diseases, announced today a strategic alliance to advance the global development of Avigan®/Reeqonus™ (favipiravir), a broad-spectrum oral antiviral currently being evaluated by Appili for the potential treatment and prevention of COVID-19. AiPharma and Appili entered into a strategic alliance agreement (the "Definitive Agreement") to establish minority positions in each other's businesses, further align their goals, and participate in each other's respective economic interests. 

Avigan®/Reeqonus™ (favipiravir) is a broad-spectrum anti-viral in oral tablet form developed by Fujifilm. Avigan® has since been authorized in 9 countries as a treatment for COVID-19. Countries purchasing Avigan®/Reeqonus™ based on a national-level approval of the therapy for the treatment of COVID-19 include Indonesia, Malaysia, Thailand, UAE and India. In a separate deal with Fujifilm, the Japanese government has contracted to purchase a stockpile of over 65 million tablets. Today only Avigan® is approved for outpatient (at home) treatment of mild to moderate COVID-19. Worldwide sales of Avigan® have reached $190,000,000 in 2021, with at least 1.5M COVID-19 patients treated with favipiravir to date.

Dr. Alessandro Gadotti, Chief Executive Officer at AiPharma said: "This is an exciting and important partnership for us. Our work with Appili will have real impact for people and communities around the world. The strength of oral antiviral treatments, such as Avigan®/Reeqonus™, in real terms is that they fight COVID-19 in the community and not in hospitals - which can majorly reduce pressures on healthcare systems. Our joint product portfolio puts us on the front line in the fight against COVID-19 and future pandemic preparedness. Our company was established by a team of drug development, infectious disease, data scientists and commercialization experts. We believe that this expertise, paired with Appili's promising pipeline of specialty therapeutics, will allow us to evolve into a global integrated infectious disease healthcare company."

Under the equity share swap agreement, AiPharma will receive that number of Class A common shares of Appili equal to 24% of the issued and outstanding Appili shares immediately prior to the agreement (calculated on a non-diluted basis). AiPharma has also been granted certain investor rights, including pre-emptive rights, consent rights and registration rights. Assuming no further equity issuances, it is expected that AiPharma will hold approximately 19.4% of the issued and outstanding Appili Shares immediately following closing.

In exchange, Appili will receive approximately 6% of the issued and outstanding AiPharma shares (calculated on a non-diluted basis).

The Toronto Stock Exchange has conditionally approved the transactions, and the companies expect the transaction to be completed in Q4 2021.

"COVID-19 continues to be an immense health threat with little relief in sight. The world needs safe and efficient antivirals that can help alleviate the threat of COVID-19, and I believe Avigan®/Reeqonus™ has the potential to change the trajectory of this pandemic," said Dr Armand Balboni, M.D., Ph.D., Chief Executive Officer of Appili Therapeutics. "This partnership will help us further streamline activities and move quickly following PRESECO readout to key clinical, regulatory, and commercial milestones."

The partnership between Appili and AiPharma will include the formation of a joint scientific steering committee to further coordinate global clinical and regulatory activities for Avigan®/Reeqonus™ around the world. The steering committee will include the following members:

• Dr. Armand Balboni; Chief Executive Officer, Appili
• Dr. Yoav Golan; Chief Medical Officer, Appili
• Dr. Alessandro Gadotti; Chief Executive Officer, AiPharma
• Dr. Richard Kaszynski; Chief Medical Officer, AiPharma

Additional Early Warning Disclosures of AiPharma^[1][2]

Pursuant to the terms of the Definitive Agreement, AiPharma has agreed to subscribe for and purchase (the "Investment") 15,079,709 common shares of the Appili ("Appili Shares"), in consideration for the issuance of shares of AiPharma, representing approximately 6% interest in AiPharma as at September 28, 2021, with a value, based on the closing price of Appili's shares on the Toronto Stock Exchange on September 28, 2021, of approximately C$15.3 million.

Immediately prior to the Investment, AiPharma, its affiliates and joint actors owned no voting or equity securities in the capital of Appili. Upon closing of the Investment, AiPharma and its affiliates will own 15,079,709 Appili Shares, representing approximately 19.4% of the currently outstanding Appili Shares, on a non-diluted basis. When acquired, the Appili Shares will be held by AiPharma for investment purposes and in furtherance of the strategic alliance of Appili and AiPharma on the potential joint development and commercialization of favipiravir and all other molecules of Appili's portfolio, as is further provided for in the Definitive Agreement. Depending on market conditions and other factors, including AiPharma's business and financial condition, AiPharma or its affiliates may acquire additional securities of Appili or dispose of some or all of the securities of Appili that it owns at such time.

This news release is issued under the early warning provisions of Canadian securities legislation. An early warning report with additional information in respect of the foregoing matters will be filed and made available on the System for Electronic Document Analysis and Review (SEDAR) at www.sedar.com under Appili's profile. AiPharma is a limited liability company organized under the laws of the State of Delaware. AiPharma's address is One JLT (14th Floor), Jumeriah Lakes Towers, Dubai, United Arab Emirates, PO Box 103805. To obtain a copy of this report, you may also contact Mr. John White (General Counsel, AiPharma) at +971 58 554 8666.

For further information please contact:
Aoife Van Wolvelaere, Edelman
Aipharmaglobal@edelman.com 

Mary O'Brien, AiPharma
mary@aipharmalab.com

About AiPharma 
AiPharma is a biopharmaceutical company focused on discovering, developing, and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleotide chemistry, biology, biochemistry, and virology, AiPharma has built a nucleotide prodrug platform to develop novel product candidates to treat single-stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, AiPharma is focused on the clinical and commercial development of orally available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). AiPharma also holds exclusive commercial rights for Avigan in Russia and China. For more information, please visit www.aipharmalab.com.

About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan/Reeqonus for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.

About Avigan® / Reeqonus™ (favipiravir)
Avigan® / Reeqonus™ (favipiravir) is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Following promising clinical studies, Russia, Thailand, Indonesia, India and Malaysia approved favipiravir-based antiviral medications for the emergency treatment of COVID-19. In a separate deal with Fujifilm, the Japanese government has contracted to purchase a stockpile of over 65 million tablets.

Additional clinical trials for favipiravir in COVID-19 are ongoing in the United States, China, India, and the United Kingdom. Unlike most other interventions that researchers are evaluating in the COVID-19 indication, favipiravir has already been thoroughly studied in human trials outside of North America and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug in controlled clinical trials, and more than 30,000 people having received Avigan in Observational Studies. The safety profile has been further confirmed by the hundreds of thousands of patients that have received Favipiravir during the COVID-19 pandemics in the authorized countries. Favipiravir's oral tablet form may also provide advantages in the community setting over other COVID-19 interventions, which often require injection or intravenous administration.

 

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SOURCE AiPharma Global Holdings LLC

FAQ

What is the significance of the strategic alliance between AiPharma and Appili Therapeutics?

The strategic alliance aims to enhance the global development of Avigan®/Reeqonus™ for COVID-19 and streamline clinical operations.

What percentage of Appili shares will AiPharma acquire?

AiPharma will acquire approximately 19.4% of Appili's shares following the agreement.

How much revenue did Avigan® generate in 2021?

Avigan® generated approximately $190 million in sales in 2021.

What countries have authorized Avigan® for COVID-19 treatment?

Avigan® has been authorized in Indonesia, Malaysia, Thailand, UAE, and India as a treatment for COVID-19.

What are the terms of the stock swap agreement between AiPharma and Appili?

AiPharma will acquire approximately 6% of AiPharma shares while receiving Class A common shares of Appili equal to 24% of their outstanding shares.