We will work diligently to embed our revised operational strategies into the
organisational framework, which will assist us in advancing a larger number of our
molecular assets into the clinical stages of their development cycle
DEAR
SHAREHOLDERS,
FY24 was a satisfying year as we crossed important milestones in progressing our
research assets.
FOR Samalisant, our lead research asset, completing the phase-2a study in June 2023
was a significant milestone. We plan to meet with FDA authorities to seek their guidance
for a pivotal phase-3 study. This study will target EDS in patients with narcolepsy with
or without cataplexy. We also have plans to initiate studies of other indications for this
molecule, which will unfold as we progress. Masupirdine, our other lead molecule, is
currently undergoing phase-3 clinical trials. It is indeed very rewarding to have made it
to this point after 16 years of relentless pursuit by our team. While this is a
challenging study owing to the difficulty in enrolling patients, we hope to complete the
study in the next 24 months and await the results. During the fiscal, we initiated the
phase-2a open-label study for Ropanicant in January 2024 and completed patient enrolment
by May 2024. We should get the results by August/September 2024.
Looking at the bigger picture, it is very heartening to see our relentless pursuit has
brought us to an enviable stage where we have more than 50% of our research assets at the
clinical study stage. This places us in a unique position in the NCE development.
The other important milestone of FY24 was that we set into motion our much-improved
operational strategy that promises to optimise the cost and time for molecule
development.The results have been quite encouraging. The enrolment for the phase-2a study
to assess the safety and efficacy of Ropanicant in the MDD patient population was
completed ahead of schedule, indicating reduced clinical development cost and time.
Also, for SUVN-16107, a phase-1 ready clinical candidate, the phase-1 study synopsis is
designed to evaluate the role of potential translational efficacy biomarker early in the
trial at different doses.This early evaluation may provide key information for the future
phase-2 proof of concept trial design. The initial successes have buoyed the confidence of
our team in the altered strategies, and we will work diligently to embed them into the
organisational framework, which will assist us in advancing a larger number of our
molecular assets into the clinical stages of their development cycle.
Since we are in a high-risk business space where years of effort and huge resource
investment could be reduced to nought in a minute, shareholders would be concerned about
the financial runway ahead of us to fund our research endeavours. We have a corpus of T240
crore, much of which is from the proceeds of the recently concluded rights issue. This
repository should fund business operations for the next 24 months.
On a personal note, I am very happy to be where I truly belong. In research, which is
my undying passion. I am free from the pressure of quarterly updates on performance,
margins, projects, et al. My unwavering focus is on the research and progress of our
research assets.
I am an incurable optimist. I remain steadfast in reaching that one molecule to its
endpoint.
That would be our entire team's happiest moment. We would have left our indelible mark
on the world for generations.
Before I close, I thank our esteemed shareholders, partners and other stakeholders for
believing in our story, expressing their confidence in our capability, and extending their
support for our long journey of endurance.
Warm regards, VENKATESWARLU JASTI
CHAIRMAN & MD