Suven Life Sciences : Annual Report FY 2022-23 (Book)

SUVEN

LIFE SCIENCES

LIMITED

MASUPIRIDINE

SUVN-502

SAMELISANT

SUVN-G3031

USMARAPRIDE

SUVN-D4010

ROPANICANT

SUVN-911

M O V I N G

CLOSER

34TH ANNUAL REPORT 2022-23

CONTENTS

IT'S TIME YOU KNOW

WHO WE ARE NOT.

TO APPRECIATE WHO WE TRULY ARE!

We are not like any other company you know.

We do not generate profits every quarter. On the contrary, we have reported losses for years together.

Because our product generation batch time is not a few hours, or days or weeks. It is years. About 13-15 years.

And even after that, we are not certain that we will generate any returns at all.

THIS IS SUVEN LIFE SCIENCES.

We are innovators.

Mavericks who delve into the darkness of the unknown. Undertake unfamiliar journeys with the hope of creating something that never existed on the Earth. And leave our mark on the world for generations.

We focus on 'Return on Life' as opposed to 'Return on Investment' for when our efforts see the light of day, millions across the world will live better lives.

We patiently persevere every day, every month, every year, with the passion of Moving Closer to End point.

FOR THAT IS WHEN OUR EFFORTS WILL SEE THE

FIRST RAY OF THE SUN'S LIGHT.

Established in 2003,	13	that address neuro-
we are an NCE		degenerative disorders
developer based in		such as cognitive
India who is patiently	molecules...	impairment associated
developing...		with Alzheimer's disease,
		Attention Deficient
		Hyperactivity Disorder
		(ADHD), Huntington's
		disease, Parkinson,
		Bipolar disorder and
		Schizophrenia and Major
		Depressive Disorders
		(MDD), pain and sleep
		disorders etc.

Out of the...	48
	inventions...

H

We have 1,000 invested more

than... crore...

that we ideated, evaluated and brainstormed on over our two-decadal journey.

in our R&D efforts in the ardent hope of moving closer to the end point.

And this investment is yet to generate any return yet.

002	CLOSER
	MOVING

We are the only Indian NCE-focused player with this large basket of molecules addressing CNS Disorders.

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ANNUAL REPORT 2022-23	OVERVIEW	REPORTS	STATEMENTS

BETWEEN 2012 & 2023, WE CREATED MANY MILESTONES.

BUT THEY HAVE GONE LARGELY UNNOTICED!

BECAUSE THEY DID NOT GENERATE THE RETURNS WHICH THE COMMON INVESTORS ASPIRES FOR.

FOR US, WE MADE CONSIDERABLE PROGRESS IN PROGRESSING OUR MOLECULES HIGHER IN THE DEVELOPMENT PIPELINE.

THE LAST FIVE YEARS

HAVE BEEN SEMINAL.

Despite a challenging global macro environment including COVID-19, last five years progressed very well both in terms of research and clinical projects with scientific results, scientific milestones, clinical milestones and molecules progressing to the next stages of development.

OUR CLINICAL PIPELINE

MASUPIRDINE

(SUVN-502)

		pure 5-HT6 receptor	After a detailed analysis of the clinical
	ASUPIRDINE, a
	Mantagonist is our lead clinical	data and discussion with experts
	candidate. It underwent a Phase 2	and the FDA, we planned a Phase
	clinical study for Alzheimer's disease	3 clinical trial for the treatment of
	(AD) but unfortunately did not	agitation in Alzheimer's type dementia
	meet the primary endpoint. But we	(NCT05397639).
	continued to look for a way to move
	forward this molecule for other
	indications.

Here is how we progressed over the last five years:

FY2018

FY2019

FY2020

FY2021

FY2022

FY2023

FY2026

Completion of

Announced

Preparation

Phase 3 study

Initiation of

Patient

We expect to

Phase 2 study

Phase 2 study

of synopsis

protocol

the Phase 3

enrollment

complete the

enrollment

results

for agitation

finalization

study

is in progress

study by the

for cognitive

Identification

in AD in

and

Enrollment of

across USA &

end of 2025

deficits in AD

consultation

submission to

Europe

of potential

First patient

with experts

FDA

utility of

Masupirdine

Completion

Initiation

in the

of FDA

of clinical

treatment of

interaction

study related

agitation (Post

(pIND

activities

hoc analyses

meeting) for

results)

guidance on

study design

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CLOSER	ANNUAL REPORT 2022-23	OVERVIEW	REPORTS	STATEMENTS

OUR CLINICAL PIPELINE

SAMELISANT

(SUVN-G3031)

					to evaluate its safety, tolerability,	The study was initially planned to
	AMELISANT is an innovatively
	Sdesigned, best-in-class clinical	pharmacokinetics and efficacy in	be completed in 2022 but that got
	candidate. This is Suven's front-	Narcolepsy (NCT04072380). Suven is	delayed as patient enrollment was hit
	running molecule targeted against	also planning a second Phase 2 PoC	owing to COVID-19 pandemic.
	Narcolepsy (excessive daytime sleep	study for the potential treatment of
	disorder).	cognitive disorders.
	The product is undergoing a	The ongoing Phase 2 study on
	Phase 2, Double-blind, Placebo-	Narcolepsy in North America is
	controlled, Parallel-group, multi-	expected to be completed during
	centre proof-of-concept (PoC) study	2023.

Here is how we progressed over the last five years:

OUR CLINICAL PIPELINE

ROPANICANT

(SUVN-911)

ROPANICANT is a potent and selective a4b2nAChRs antagonist with

excellent ADME and safety properties and robust efficacy in various animal models of depression.

It addresses major limitations of current depressive disorder therapeutics by offering rapid onset of action, no sexual dysfunction and pro- cognitive effects. Ropanicant has been evaluated for its safety, tolerability, and pharmacokinetics under US-IND

(NCT03155503) following single and multiple oral administration in healthy subjects. It is safe and well tolerated in healthy adult male subjects with dose-dependent pharmacokinetics. The projected human efficacy concentrations were achieved in

the Phase 1 study. Food and age have no effect on pharmacokinetics (NCT03551288). Ropanicant Phase 2

enabling rodent and non-rodent safety studies has been completed without any concern for further development.

Suven is planning to initiate a Phase 2 PoC study for the treatment of depressive disorders in the near future.

FY2018

FY2019

FY2020

FY2021

FY2022

FY2023

FY2024

Preparation

IND

Completion

Completion

Study

Completion

Completion of

of synopsis

submission to

of Interim

of mitigation

crossed 50%

of about 95%

study

for Phase

FDA

Analysis (IA)

strategies like

enrollment

enrollment

Data readout

2 study in

for sample

additional

(Positive effect

Initiation of

(Positive effect

expected in

narcolepsy in

size re-

sites in USA

of mitigation

the Phase 2

of mitigation

September/

consultation

estimation

and new

strategies)

study in USA

strategies)

October 2023

with experts

Sample size

country

Enrollment of

We expect to

(Canada)

increase from

First patient

get the result

to boost

114 subjects

of our efforts

enrollment

to 157

subjects

Here is how we progressed over the last six years:

FY2018

FY2019

FY2020

FY2021

FY2022

FY2023

Completion of

Completion

Completion of

Completion of

Initiation

Completion

additional Phase 1

of large scale

Phase 2 enabling

FDA interaction

of Protocol

of Ropanicant

study

process

non-clinical

(EOP1 meeting)

development

Drug Product

Initiation of Phase 2

optimization

safety studies

for guidance on

for Phase 2

manufacturing

for Ropanicant

study synopsis

study based

under GMP for

enabling non-clinical

Completion

Drug Substance

on FDA

Phase 2 study

safety studies

of Ropanicant

Completion

manufacturing

feedback

Drug Substance

of Ropanicant

Planning protocol

manufacturing

formulation

submission to FDA

under GMP

optimization for

and Phase 2 PoC

Phase 2

study initiation

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CLOSER	ANNUAL REPORT 2022-23	OVERVIEW	REPORTS	STATEMENTS