Sam Kintz, Enliven CEO
Thank you, Rahul, for the kind introduction, and good afternoon everyone. My hope for this call is to provide you with an overview of the combined company,
which will be called Enliven Therapeutics after the transaction closes.
First, Id like to take the opportunity to tell you more about our team,
displayed on Slide 6. I co-founded Enliven with Joe Lyssikatos and Anish Patel. Joe, our Chief Scientific Officer, is a renowned medicinal chemist, who helped build and scale Array BioPharmas internal
programs and medicinal chemistry efforts. Ive had the pleasure of working with Joe on and off for the past 15 years. Joe is a co-inventor or co-author on over 220
issued patents and peer-reviewed publications, and has been a key scientific contributor to over 30 small molecule programs. Anish, our Chief Operating Officer, brings development, medical affairs, and commercial experience. In 2021, we expanded our
management team to include Dr. Helen Collins and Ben Hohl. Helen, our Chief Medical Officer, recently served as Chief Medical Officer at Five Prime Therapeutics until its acquisition by Amgen, where she led the development of bemarituzumab, a
potential first-in-class investigational targeted antibody for a subset of gastric cancer, which has been granted Breakthrough Therapy Designation by the FDA.
Helens core leadership team from Five Prime have also joined Enliven to help build out our clinical development organization. And Ben, our Chief Financial Officer, brings a depth of business, financial and investment experience to round out
our leadership team. We also benefit from a distinguished board of directors and scientific advisors, whose experience and insights have been and will be invaluable to Enliven as we continue to advance our pipeline. And were very pleased that
Rahul will continue to serve on the board. I will also note that we have been supported by industry leading healthcare investors, who continue to support the company, as demonstrated by our insider participation in the concurrent private financing
that Rahul mentioned. We are also very excited to welcome Fairmount, Venrock, Fidelity, RA Capital, Frazier and Commodore to the Enliven family as new investors.
As we move to Slide 7, you will see that our R&D team has a strong track record of success. In particular, our chemists have been the inventor or co-inventor of four FDA-approved drugs and over 20 product candidates that have advanced into clinical trials. Our research team is now complemented by the amazing clinical
development team that Helen has built, and our team is eager to repeat its success with our parallel lead product candidates, as well as future pipeline programs.
As we take a look at the next slide, Slide 8, we have two parallel lead product candidates and we expect to have two clinical stage programs by the end of the
year. ELVN-001 is our highly selective, active site BCR-ABL kinase inhibitor with activity against key resistance mutations for the treatment of CML. We recently
initiated our Phase 1 study, and depending on enrollment, expect to provide early clinical data by the end of 2023. ELVN-002 is a potent, selective and irreversible HER2 and
pan-HER2 mutant kinase inhibitor for the treatment of HER2 mutant lung cancer and other HER2-driven tumor types. We are expecting to file an IND for 002 with the FDA this quarter.
Additionally, we believe our ongoing discovery efforts will continue to fuel our pipeline, with an emphasis on more novel approaches and targets. In the first
half of 2023, we expect to nominate a product candidate for our third program.
On Slide 9 we will dive in to our first program, ELVN-001. Although the approval of BCR-ABL TKIs has improved the life expectancy of patients with CML significantly, tolerability, safety, resistance and patient convenience
concerns have become more prominent as patients can now expect to live on therapy for up to decades. In fact, since the approval of Gleevec over 20 years ago, median overall survival for newly diagnosed patients with CML in the US has not been
reached. CML is now a chronic condition, and issues associated with the available treatment options drive approximately 20% of patients to switch