Appili Celebrates a Notable 2019 and Looks Ahead to Significant Milestones in 2020  

January 7, 2020  

Dear Appili Stakeholder:

 

I want to take the opportunity to thank you for your support after an incredibly active and important year at Appili Therapeutics. Since accepting the position of CEO in December, I have spoken with many stakeholders and have thoroughly enjoyed the opportunity to hear your thoughts and to continue to tell the Appili story.

 

The need for anti-infective innovations has never been clearer. With signals for more favorable market conditions for companies like Appili, we remain poised to deliver on our mission: identify and advance programs for urgent needs in the infectious disease space.

 

Appili is purposefully unique in its approach to addressing those needs and our success as a company will continue to be tied to the work we do as a team. We will continue to build a distinguishable company with great employees and a corporate culture that continually strives to solve serious problems in infectious diseases. We had a notable 2019 and look forward to continuing that success in 2020!

Key 2019 Operational Highlights

·       In July, we successfully completed the transition to a public company when Appili began trading on the TSX Venture Exchange under the ticker symbol ‘APLI’

·       In December, I was honored to accept the CEO title for Appili. I look forward to using my experience coordinating regulatory, government, and clinical development to spur value creation and address unmet patient needs in the anti-infective space

 

2019 Pipeline and Clinical Advancements

·       ATI-2307: We successfully acquired a new anti-infective asset with exclusive worldwide rights (ex-Japan). With a highly differentiated mechanism of action that is not currently susceptible to existing resistance mechanisms, ATI-2307 is being developed to address drug-resistant fungal infections that pose a significant health threat and have limited treatment options

·       ATI-1501: In December, we entered into a commercialization agreement with Saptalis Pharmaceuticals LLC for our taste-masked liquid oral suspension of the antibiotic metronidazole. Through this agreement, Appili is eligible to receive multiple milestone and royalty payments; Saptalis will be responsible for overseeing the regulatory review, manufacturing and preparation for the anticipated commercialization of ATI-1501 in the U.S.

·       ATI-1701: Our research partners presented positive interim data on Appili’s ATI-1701 program at the Chemical and Biological Defense Science & Technology Conference (CBD S&T), which showed in preclinical models complete (100%) protection 90 days after vaccination from lethal exposure to Francisca tularensis. This promising positive incremental data are supportive of continued work towards completing the pivotal studies needed for FDA submission and approval of the first vaccine for the prevention of weaponized tularemia.

·       ATI-1503: We received a $3M US grant from the US Department of Defense to continue advancing our ATI-1503 antibiotic program, which targets drug-resistant, Gram-negative bacteria also known as ‘superbugs.’ The ATI-1503 program has the ability to target 4 out of 6 “ESKAPE” pathogens, which are the leading cause of hospital acquired infections worldwide

2020: Continuing to Differentiate

At Appili, we have made a conscious choice to maintain a diversified anti-infectives portfolio to address fungal infections, protect against bioweapons, and develop novel antibiotics. We will seek to build real value by virtue of our diversified portfolio that addresses true unmet needs while also leveraging market incentives like the Priority Review Voucher program, biodefense stockpiling, and niche indications with lower barriers to entry. We will continue to seek out opportunities to further build a distinguishable product portfolio that leverages market incentives that differentiates Appili from other companies in our space. 

Thank you for your ongoing support and interest. We look forward to executing on additional opportunities to tackle serious public health challenges and generate shareholder value as we strive to do well by doing good.

Armand Balboni, MD, PhD

Chief Executive Officer, Appili Therapeutics