Engage Therapeutics Shareholder Update Letter
Please see below a shareholder update letter sent today by Greg Mayes, CEO of Engage Therapeutics. As many of you know, the company has attracted strong strategic interest, but the management team has remained singularly focused on executing on their clinical trial strategy. We caught up with Greg in person this past Friday and are excited that the open label portion of the Phase 2b trial is off to a strong start. We anxiously await additional data as we believe Staccato Alprazolam represents a true breakthrough for epilepsy patients around the world.
May 7, 2018
Dear Engage Therapeutics Shareholder:
Eighteen months ago I sat down for lunch with Dr. Jackie French in a Lower East Side Manhattan, Turkish-style restaurant called Galata, located across the street from the NYU Comprehensive Epilepsy Center to talk about a Phase 2a trial that she had recently completed and which showed the rapid abortion of epileptic seizure activity in uncontrolled, photosensitive epilepsy patients. She asked, “Greg, what do you do when your son has a seizure?” I said, “we ride the storm out; there’s nothing you can do, no medicine, literally nothing.” To that Jackie replied, “not yet - but I think we may have found a rescue treatment that works fast enough to abort an active seizure.”
With your investment in and support of Engage Therapeutics in September 2017 we have now begun to take the steps necessary to evaluate whether we can bring such an EpiPen®-like treatment option to the epilepsy community. In March, 2018 we opened our first four investigative sites for the Phase 2b study we have named StATES (Staccato Alprazolam Terminates Epileptic Seizures). On May 2, 2018 our first patient was dosed (see press release: http://www.globenewswire.com/news-release/2018/05/03/1495829/0/en/Engage-Therapeutics-Doses-First-Patient-in-Phase-2b-Trial-of-Epilepsy-Seizure-Rescue-Therapy-Staccato-Alprazolam.html).
The clinical operations bell has clearly been rung at Engage Therapeutics and we are now well on our way toward enrolling an additional 107 patients across 40 U.S. sites with topline data expected in the second half of 2019. Robust patient selection criteria is our key to success on the StATES study. To that end, we are relying on Dr. French’s Epilepsy Study Consortium to independently screen patients that sites put forward as potential candidates for the Study to ensure they are a patient that will likely showcase the potential of the investigational product to rapidly terminate epileptic seizure activity and keep the patient seizure free for a period of time post administration.
Our number one focus remains the completion of enrollment for the StATES study in a timely and compliant manner. We are also exploring how the study and/or the outpatient extension portion of the trial can incorporate a seizure detection and/or seizure prediction device technology into the StATES clinical program. If these seizure detection and prediction technologies do come on line in the next several years as most predict they will, patients will have an even greater need for an extremely fast acting product like Staccato Alprazolam when they are alerted to a pending or actual seizure. Bottom line – we have an opportunity to showcase Staccato Alprazolam as the best therapeutic complement to emerging seizure detection and/or prediction technologies.
We also think it’s critical that we expand our evaluable patient population to include children ages 11-17 and ultimately even younger. To that end, we have launched a robust pk modeling strategy and we are already executing Phase 1 pk studies that should allow us to reach many pediatric patients in the StATES study early in 2019.
Financially, we are strong and have limited our cash burn with a small but mighty 4 employee team that relies heavily on our CNS-specific CRO – Peachtree Bioresearch Solutions – and other highly experienced industry consultants. We plan to have sufficient cash on board to get us to topline data in H2 2019 and we plan to have a cash runway beyond that date that would give us time to review the data with potential strategic partners and get the Agency’s insights and reaction to the StATES outcome and proposed next steps for clinical development.
With respect to the future, we can say with great confidence that, if the StATES data ultimately supports our clinical hypothesis, there will be several larger companies interested in working with us on this novel drug-device combination. In fact, shortly after our Series A round closed, we received a formal proposal to be acquired. While the deal never materialized because the purported acquirer was itself acquired during the confirmatory due diligence period, the agreed upon terms were attractive and the outcome of their due diligence certainly validated the technology and the path that we now find ourselves on. Moreover, there remains great interest in a fast acting, epileptic rescue treatment like Staccato Alprazolam. Late last month UCB announced it acquired the rights to Proximagen’s Midazolam Nasal Spray for up to $370m.
Thank you for joining us on this journey. The opportunity to literally change how patients with uncontrolled epilepsy are able to immediately respond to and terminate active and evolving breakthrough seizures is massive. I remain personally and professionally committed to doing all that I can do every day to make this concept a reality. Please do not ever hesitate to pick up the phone or email me if you have any questions or would just like an update.
Without all of you, this would not have been possible.
With sincere thanks,