Everest Medicines Enters into Comprehensive Agreements with Providence Therapeutics to Advance mRNA Vaccines and Therapies, including COVID-19 Vaccines, in Asia Emerging Markets

SHANGHAI, Sept. 13, 2021 /PRNewswire/ -- Everest Medicines Limited (HKEX 1952.HK, "Everest" or the "Company") announced today two separate definitive agreements ("Agreements") with Providence Therapeutics Holdings Inc. ("Providence"), a clinical stage biotechnology company developing messenger RNA ("mRNA") therapeutics and vaccines, to (i) license rights to Providence's mRNA COVID-19 vaccine candidates in Asia emerging markets, including Greater China, Southeast Asia and Pakistan, and (ii) establish a broad, strategic partnership to develop mRNA products globally leveraging Providence's cutting-edge mRNA technology platform ("mRNA Platform").

Under the terms of the Agreements, Everest gains rights to Providence's mRNA COVID-19 vaccines in Greater China, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Pakistan, Philippines, Singapore, Thailand, Timor-Leste and Vietnam (collectively, "Everest Territories"). Providence's lead mRNA COVID-19 vaccine candidate, PTX-COVID19-B, currently in Phase 2 clinical trials, has demonstrated that it is generally safe and well tolerated and that the PTX-COVID19-B dosed subjects have high neutralization titers against the original strain of SARS-CoV-2 (G614) in an S protein-typed pseudovirus assay. All subjects produced neutralizing antibodies after the first dose and the levels increased more than 10-fold after the second dose. The sera from PTX-COVID19-B vaccinated subjects also had high neutralization titers against current variants of concern ("VOC") Alpha, Beta and Delta, that compare favorably to currently approved mRNA vaccines. Everest will also gain rights to Providence's next generation mRNA COVID-19 vaccine candidates against specific VOC which are in pre-clinical development.

Everest and Providence will also enter into a 50/50 global collaboration under which the parties will develop two additional prophylactic or therapeutic products ("Collaboration Products"). Global rights to Collaboration Products will be jointly owned by Everest and Providence. Everest also will be enabled to create and develop products ("Additional Products") using Providence's mRNA Platform for product discovery across a broad range of other prophylactic and therapeutic areas. The collaboration includes full technology transfer of Providence's current and future manufacturing processes to Everest. This transfer will allow the Company to, pending regional product approval, produce and distribute these important medicines locally, enabling people in Greater China and other Asia territories access to differentiated and clinically validated mRNA vaccines for COVID-19, mRNA vaccines for other infectious diseases, as well as mRNA therapies for a range of devastating diseases.

"We're thrilled to enter into this agreement with a strong partner such as Everest as we work together to bring novel mRNA vaccines, like PTX-COVID19-B, to patients in need around the world and help combat COVID-19 as well as other diseases," commented Mr. Brad Sorenson, CEO of Providence Therapeutics. "In addition, this transaction structure with equity consideration and profit-sharing helps to align ongoing corporate interests between Everest and Providence, fostering future collaboration for innovative mRNA vaccine development across a range of disease areas."

"I am excited to work with Providence and we share in their passion to make affordable, innovative, high quality medicines available to patients in need. We believe that mRNA vaccines for COVID19 can provide another option in the armamentarium for fighting this pandemic. Gaining exclusive access to a unique and clinically-validated mRNA technology platform through this strategic collaboration redoubles our commitment to accelerate global pharmaceutical innovation and deliver best-in-class medicines to people in China and other parts of Asia. The platform will enhance our discovery efforts and will allow us to explore the promise of mRNA therapies for patients across a variety of key disease areas," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "The rapid development and commercialization of PTX-COVID19-B and PTX-COVID19-Variant, two leading mRNA COVID-19 vaccine pipeline products, provide significant opportunity to Everest and Providence, as well as to patients in Asia and we look forward to progressing development of these potentially best-in-class vaccines."

Transaction Terms

Under the terms of the transaction Agreements, Providence will receive the following considerations

(i) for COVID-19 vaccines:
- US$50 million in initial upfront payment to be paid in cash
- Greater China and Singapore, up to US$100 million in profit-sharing on COVID-19 vaccines, and once profit share has reached an aggregate amount of US$100 million, mid to high single-digit royalties, and in Everest Territories outside of Greater China and Singapore, mid-teens royalties on COVID-19 vaccine sales

(ii) for Collaboration Products, Additional Products, and the mRNA technology platform:
- US$50 million in initial upfront payment to be paid in cash
- Up to US$300 million in future milestone payments to be paid in newly-issued Everest stock, based on the achievement of certain technology transfer, manufacturing, preclinical, development and commercial milestones

Conference Call Information

Everest Medicines will host a conference call on Tuesday 14 September 2021 at 8:00 AM Hong Kong Time (Monday 13 September 2021 at 8:00 PM US Eastern Time) to discuss the partnership with Providence.

The live webcast can be accessed through the following link:

https://edge.media-server.com/mmc/p/i6xnmah5

Alternatively, participants may dial in to the conference call using the below dial-in information:
US/Canada dial-in: +1 (855) 493-3549
International dial-in: +1 (929) 517-0951
Conference ID: 7686517

A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com.

About PTX-COVID19-B

PTX-COVID19-B is an mRNA vaccine in Phase 2 development for the treatment of COVID-19, which is designed to encode the S protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (LNP). Interim data from Providence's Phase 1 study showed that PTX-COVID19-B demonstrated strong virus neutralization capability and produced a level of antibodies in participants in the treatment arm that compare favorably to those produced by other mRNA vaccines that have been approved for use against COVID-19. The treatment was generally safe and well tolerated.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia emerging markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.  

About Providence Therapeutics

Providence is a leading Canadian clinical stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, Alberta and Toronto, Ontario. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs. For more information, please visit providencetherapeutics.com.

SOURCE Everest Medicines