Suven Life Sciences : June 03, 2023Suven announces two poster presentations from the phase-2 (PoC) study on samelisant (SUVN-G3031)

Suven Life Sciences announces two poster presentations including patient baseline characteristics and demographics from the phase-2 Proof of Concept (PoC) study on samelisant (SUVN-G3031) at the SLEEP-2023 annual meeting

HYDERABAD, INDIA (June 3, 2023) Suven Life Sciences presenting two posters at SLEEP-2023, the 37th annual meeting of the Associated Professional Sleep Societies, LLC (APSS) being held at Indianapolis, USA during June 3-7, 2023.

The poster presentations include patient baseline characteristics and demographics from the phase-2 PoC study on Samelisant in patients with Narcolepsy with and without Cataplexy and preclinical efficacy data indicating potential utility of samelisant in treatment of excessive daytime sleepiness in Parkinson's disease.

Details of the poster presentations are as below:

• Samelisant (SUVN-G3031), a Histamine 3 Receptor Inverse Agonist for the Potential Treatment of Excessive Daytime Sleepiness in Parkinson's Disease (Monday, June 5; Poster Board Number: 61)
• Samelisant, Histamine 3 Receptor Agonist for the Potential Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy (Tuesday, June 6; Poster Board Number:

302)

Suven has the exhibit booth at the SLEEP-2023. Please visit us at booth # 1009.

About samelisant Phase-2PoC study: Samelisant phase-2 PoC clinical study is a double-blind,placebo-controlled,parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of 2 mg and 4 mg samelisant compared with placebo in narcolepsy patients with and without cataplexy. Approximately 190 adult patients were randomized at a ratio of 1:1:1 to 2 mg samelisant, 4 mg samelisant, or placebo at 58 clinical trial sites across the USA and Canada. The primary efficacy endpoint is change from baseline in the mean Maintenance of Wakefulness Test (MWT) score at Day 14. Key secondary endpoint is change from baseline in the mean total Epworth Sleepiness Scale (ESS) score at Day 14.

The study has completed the enrollment. Data readout for the study is anticipated in August 2023.

About Samelisant (SUVN-G3031): Samelisant is a novel, potent, selective, brain penetrant and orally active Histamine H3 receptor inverse agonist. H3 receptor blockade elevates histamine, norepinephrine and dopamine in brain, a potential for treatment of sleep related disorders. Samelisant exhibited wake promoting activity in orexin knockout mice (an animal model of narcolepsy) and also showed similar trend in healthy human subjects (phase-1 study observations). Pre‐clinical in vitro and in vivo efficacy studies, supporting neurochemical studies, pharmacokinetic studies, safety studies and phase‐1 clinical studies under US IND has been successfully completed for samelisant.

Suven Life Sciences Limited

Registered Office: 8-2-334I SDE Serene Chambers I 6th Floor Road No.5 I Avenue 7 Banjara Hills I Hyderabad - 500 034 I Telangana I India I CIN: L24110TG1989PLC009713

Tel: 91 40 2354 1142/ 3311/ 3315 Fax: 91 40 2354 1152 Email: info@suven.com website: www.suven.com

About Sleep 2023 annual meeting: SLEEP 2023 is the 37th annual meeting of the Associated Professional Sleep Societies (APSS), a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). As the premier clinical and scientific meeting in the sleep field, SLEEP 2023 meeting brings together sleep medicine physicians, sleep and circadian scientists, and other health care professionals to discuss the latest advances in sleep science and new developments in the diagnosis and treatment of sleep disorders. The SLEEP meeting provides evidence-based education to advance the science and clinical practice of sleep medicine, disseminates cutting-edge sleep and circadian research, and promotes the translation of basic science into clinical practice.

About Narcolepsy: Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness (EDS) and intermittent, uncontrollable episodes of falling asleep during the daytime. These sudden sleep attacks may occur during any type of activity at any time of the day. Narcolepsy is segmented into 2 categories: narcolepsy type 1 (with cataplexy, a sudden loss of muscle tone) and narcolepsy type 2 (without cataplexy). About one in 2,000 people have some form of narcolepsy. Symptoms present in the teens or early twenties, but occasionally occur as early as 5 years of age or after 40 years old.

About Suven Life Sciences ("Suven"): Suven is a clinical stage biopharmaceutical company, focused on discovering and developing novel pharmaceutical products, for central nervous system ("CNS") disorders. Our focus has been on discovery and development of innovative molecules targeting diseases and areas, which has undiscovered medical treatment opportunities. Our Company singularly focuses on development of "New Chemical Entities" ("NCEs") molecules for CNS diseases such as Alzheimer's, various forms of Dementia, Narcolepsy, Major Depressive Disorder ("MDD"), Attention Deficient Hyperactivity Disorder ("ADHD"), Huntington's disease, Parkinson, Bipolar disorder and different forms of neuropsychiatry disorders, gastrointestinal disorders and pain disorders. Suven has 7 clinical stage compounds, Masupirdine (SUVN-502) for treatment of agitation in patients with dementia of the Alzheimer's type (phase-3 ongoing), Samelisant (SUVN-G3031) for sleep disorders (phase-2 ongoing), Ropanicant (SUVN-911) for Major Depressive Disorder (phase-2 ready) and Usmarapride (SUVN- D4010) for cognitive disorders (phase-2 ready) and 3 other compounds in early stages of clinical development. In addition to clinical candidates, Suven has 8 molecules in development pipeline.

For more information please visit our website at http://www.suven.com

Risk Statement: Except for historical information, all the statements, expectations, and assumptions, including expectations and assumptions, contained in this news release may be forward-looking statements that involve several risks and uncertainties. Although Suven attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Other important factors which could cause results to differ materially including outsourcing trends, economic conditions, dependence on collaborative partnership programs, retention of key personnel, technological advances, and continued success in growth of sales that may make our products/services offerings less competitive; Suven may not undertake to update any forward-looking statements that may be made from time to time.

Suven Life Sciences Limited

Registered Office: 8-2-334I SDE Serene Chambers I 6th Floor Road No.5 I Avenue 7 Banjara Hills I Hyderabad - 500 034 I Telangana I India I CIN: L24110TG1989PLC009713

Tel: 91 40 2354 1142/ 3311/ 3315 Fax: 91 40 2354 1152 Email: info@suven.com website: www.suven.com