Corporate Presentation

March 2024 | Soleno Therapeutics

Certain Notices and Disclaimers

Forward-Looking Statements

This presentation contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; the degree of clinical utility of our products, particularly in specific patient populations; our ability to develop commercial functions; expectations regarding product launch and revenue; our results of operations, cash needs, and spending of the proceeds from this offering; financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us.

We may, in some cases, use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this presentation, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation.

You should also read carefully the factors described in the "Risk Factors" sections and other parts of our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, available at www.sec.gov, in order to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. Any forward-looking statements that we make in this presentation speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this presentation or to reflect the occurrence of unanticipated events.

Analyses in this presentation are preliminary and may be subject to change

2 | © 2024 Soleno Therapeutics

Soleno Therapeutics (NASDAQ: SLNO)

Strategic Highlights

NDA submission for DCCR1 in PWS2 planned mid-'24

Topline data from

randomized

withdrawal period

reported in Sep 2023

Met primary endpoint with significant improvements in hyperphagia

Decades-long safety

profile of parent molecule

IP protection to

mid-2030s

Protected by

multiple layers of

granted and

pending patents

Provides composition of

matter protection, as well as protection of formulations, and method of use

Potential for substantial patent term extension

Orphan Drug

and

>$2B PWS

Fast Track

market

Designations for

opportunity

PWS

Orphan

Addresses

designation in

the hallmark

US and EU. Fast

symptoms

Track granted in US

of PWS

Significant upside

Significant commercial

potential in other

potential in PWS,

indications

an orphan indication with

Orphan designation

high unmet need.

granted for GSD1a in

No approved treatments

US

for hyperphagia, the

hallmark symptom of PWS

Strong balance

sheet

Cash runway extends

beyond potential launch of DCCR

Oct 2023 ~$170M

financing

1DCCR (Diazoxide Choline) Extended-Release tablets

2Prader-Willi syndrome

3 | © 2024 Soleno Therapeutics

Prader-Willi Syndrome (PWS)

  • Complex genetic neurobehavioral/metabolic disorder due to the loss or lack of expression of a set of genes on chromosome 15
  • Birth incidence ~1:15,000 births
  • Elevated mortality rates with mean age of death ~21 - 30 years
  • Highest unmet needs
    • Hyperphagia
    • Low lean body mass/increased fat mass
    • PWS-relatedbehaviors
  • Families with a child with PWS have low quality of life
    • Caregiver burden higher for caregivers of people with PWS than those with Alzheimer's
    • Burden of care is highest after onset of hyperphagia
    • Require supervised care for life

Butler MG, et al., Genet Med. 2017 Jun;19(6):635-642.

Bellis SA, et al., The Eur J Med Genet. 2022 Jan;65(1):104379. Kayadjanian N et al., PLoS One 2018 Mar 26; 12(3): e0194655.

4 | © 2024 Soleno Therapeutics

DCCR Was Developed to Facilitate Once Daily Dosing and Improve Response

  • Choline salt chosen to improve solubility
  • Formulation developed to extend absorption throughout the GI tract
  • DCCR dosed once daily to achieve stable intraday circulating drug levels
  • Strong relationship between circulating drug levels with DCCR and therapeutic responses in PWS
  • Titration and dosing optimized to safely reach target dose and maintain therapeutic response

of

30

Circulatingconcentration diazoxide(µg/mL)

25

0

20

15

10

5

0

2

4

6

8

10

12

14

16

18

20

22

24

Hours Post-dose at Steady State PK015

5 | © 2024 Soleno Therapeutics

Mechanism of Action in PWS

Genes, 11(4), 450. https://doi.org/10.3390/genes11040450.

6 | © 2024 Soleno Therapeutics

DCCR Phase 3 Clinical Program Design

  • C601 (DESTINY PWS): Multi-center, randomized, double-blind, placebo- controlled, parallel arm study in patients with PWS (Phase 3)
  • C602: Open-label safety extension study

2-week

Run-in

C601

13-WeekDouble-blind

Treatment

C602

Open-label Extension

N = 181

Screened

Enrolled N = 158

2:1 Randomization N = 127

DCCR N = 85

Placebo

N = 42

Completed

n = 120

Early

Termination

n = 7

Enrolled N = 115

As of October 2022

N=83

Mean age = 13.5 years

44.4% M / 55.6% F

20.2% UK / 79.8% US

61.3% Deletion / 37.9% Non-deletion

7 | © 2024 Soleno Therapeutics

C601 Primary and Key Secondary Endpoints

All Data

Observed Data through

March 1, 2020

Primary Endpoint

DCCR

Placebo

DCCR

Placebo

(N = 82)

(N = 42)

(N = 82)

(N = 42)

Mean (SE) Change from Baseline in Hyperphagia at

-5.94

-4.27

-6.64

-3.51

Visit 7

(0.88)

(1.15)

(1.00)

(1.28)

LS Mean Difference [DCCR-Placebo] (SE)

-1.67 (1.29)

-3.13 (1.48)

p-value

0.198

0.037

Key Secondary Endpoints

p-value

p-value

Clinical Global Impression of Improvement at Visit 7

0.03

0.015

(CGI-I)

Mean Change From Baseline in Body Fat Mass (DXA)

0.023

0.003

at Visit 7

Caregiver Global Impression of Change at Visit 7

0.41

0.031

(Caregiver GI-C)

8 | © 2024 Soleno Therapeutics

C601 Behavioral Endpoints

DCCR vs Placebo

PWSP Domain

p-value

Aggressive Behaviors

0.048

Anxiety

0.018

Rigidity, Irritability

0.003

Compulsivity

0.008

Depression

0.185

Disordered Thinking

0.011

DBC-2

Total Score

0.009

Communication Disturbance

0.003

Social Relating

0.008

Observed values through March 1, 2020

9 | © 2024 Soleno Therapeutics

C601 Key Hormonal and Metabolic Markers

DCCR vs Placebo

Change from Baseline at Week 13

p-value

Decreased Acylated Ghrelin (active form)

0.0182

Decreased Leptin

<0.0001

Decreased Insulin

0.0110

Increased Adiponectin

<0.0001

10 | © 2024 Soleno Therapeutics

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Soleno Therapeutics Inc. published this content on 04 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 March 2024 14:15:19 UTC.