UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): September 26, 2017
SOLENO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36593 | 77-0523891 | ||
(State or other jurisdiction of incorporation) | (Commission File No.) | (IRS Employer Identification Number) | ||
1235 Radio Rd #110
Redwood City, CA 94065
(Address of principal executive offices)
(650) 213-8444
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[_] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[_] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. Regulation FD Disclosure
Attached as Exhibit 99.1 to this Current Report on Form 8-K is an investor presentation that Soleno Therapeutics, Inc. (the “Company”) may use in presentations to investors from time to time.
The investor presentation attached as Exhibit 99.1 to this Report includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained in the slide presentation are “forward looking” rather than historical.
The information included in this Item 7.01 and in Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly
1
set forth by specific reference in such a filing. The Company undertakes no duty or obligation to update or revise information included in this Report or any of the Exhibits.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
The following exhibit is being filed as part of this Report.
Exhibit
Number Description
_____________________________________________________________________________________________________________________________________________________________________________________
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SOLENO THERAPEUTICS, INC. | ||||||
Date: September 26, 2017 | ||||||
By: /s/ Anish Bhatnagar | ||||||
Anish Bhatnagar | ||||||
President and Chief Executive Officer | ||||||
3
Corporate Presentation
September 2017 | 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” section and other parts of our Quarterly Report 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.
| © 2017 Soleno Therapeutics 2
Investment Highlights
| © 2017 Soleno Therapeutics 3
Capnia and
Essentialis
Merger
Compelling
product profile
Addresses
hallmark
symptoms of PWS,
including
hyperphagia
Phase III ready
Established,
decades-long
safety profile
Strong IP
Financing
concurrent
with
completed
merger
Adequate to
advance DCCR
into Phase III
program
Multiple
downstream
orphan
indications
Hypothalamic
obesity, Smith-
Magenis
syndrome
New Lead
Asset DCCR
Financed
Through Key
Milestones
Longer-Term
Pipeline
Opportunities
Strong
Leadership
Highly
experienced
management
team
Expertise in drug
development for
rare and orphan
diseases
Creating a rare
disease
therapeutics
company
Initial focus on PWS,
a high unmet need
indication with no
approved
treatments
Merger completed
Leadership Team
• Anish Bhatnagar, M.D.
Chief Executive Officer
• Jonathan Wolter
Interim Chief Financial Officer
• Neil M. Cowen, Ph.D.
Senior VP, Drug Development
• Kristen Yen, M.S.
VP of Clinical Operations
• Patricia C. Hirano, M.P.H.
Head of Regulatory Affairs & Quality
| © 2017 Soleno Therapeutics 4
Essentialis
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
• Afflicts about 1:15,000-1:25,000 individuals
• Elevated mortality rates
• Highest unmet needs
– Hyperphagia
– Aggressive behaviors
– Body composition
• PWS families have low QOL
– Normal siblings show high rates of PTSD
| © 2017 Soleno Therapeutics 5
Diazoxide – Long History of Safe Use
DCCR – Extensive Pre-Clinical and Clinical Data
• Diazoxide I.V., Oral suspension and Capsule
– KATP channel agonist approved in 1976
– Previously used as IV treatment for malignant hypertension
– BID/TID oral suspension for the treatment of hypoglycemia due
to hyperinsulinism in infants, children and adults - remains
global standard of care
• Diazoxide Choline Controlled-Release (DCCR)
Tablet
– QD tablet formulation of choline salt of diazoxide
– Characterized in 5 Phase I and 3 Phase II studies in obese,
dyslipidemic and PWS subjects
– More than 210 treated subjects
– Protected by multiple issued patents, including composition of
matter
| © 2017 Soleno Therapeutics 6
Diazoxide Choline
Proglycem
Challenges in the Treatment of PWS
• Proglycem has not been approved for use in PWS
– Use in PWS blocked by allowed DCCR patent claims
• Proglycem product is a TID/BID oral suspension with a long bitter
aftertaste
– There are challenges with the uniformity of dosing with the oral suspension
– Rapid absorption leads to high Cmax
• Several of the most common adverse events
are Cmax-associated
| © 2017 Soleno Therapeutics 7
0
2
4
6
8
10
12
14
16
0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 114 120
Time (hr)
Di
az
ox
id
e
(µ
g/
m
L)
Diazoxide Choline Tablet Diazoxide Oral Suspension
• Soleno conceived of and patented
the use in PWS
• DCCR will be more convenient, and
potentially safer than Proglycem
– In order to facilitate independence of PWS
patients, QD dosing is critical
Orexigenic Signals:
Ghrelin
Anorexigenic Signals:
Leptin, Insulin
KATP Channels
Snord116 Deletion
• Increased activation of
orexigenic pathways
• Reduced activation of
anorexic pathways
Mechanism of Action
8
• Appetite controlled by 2 sets of neurons
in the hypothalamus that express KATP
channels
– NPY/AgRP – secrete NPY and AgRP,
appetite stimulatory neuropeptides
– POMC – secretes POMC, an appetite
suppressive neuropeptide
• NPY expression is elevated in PWS
– Loss of SNORD116 in the PWS critical
region on chromosome 15 results in
hyperphagia
• DCCR agonizes KATP channels in
NPY/AgRP neurons
– Reduces secretion of NPY and AgRP,
thereby reducing hyperphagia
HYPERPHAGIA
PC025 Pilot Study in PWS
• Randomized, Withdrawal, Single-Center Study of DCCR in overweight
or obese, genetically-confirmed PWS patients ages 10 to 22 years
– Included subjects with mild hyperphagia (Baseline hyperphagia score < 13) and with
moderate-to-severe hyperphagia (Baseline hyperphagia score ≥ 13)
| © 2017 Soleno Therapeutics 9
Screening
Open Label Treatment Phase
(Baseline to Visit 7)
N=13
Double-Blind, Placebo-Controlled,
Randomized Withdrawal Phase
(Visit 7 to Visit 8)
N=11
4 weeks
10 weeks
4 weeks
Patients escalated from
1.5 mg/kg to 4.2 mg/kg
Continue on last DCCR dose or
placebo equivalent
5 subjects who completed the double-blind randomized withdrawal phase
elected to enroll in a subsequent 6-month open-label extension study
Hyperphagia Response During Open-Label Treatment
Greater at Highest Dose and Moderate-Severe Hyperphagia
| © 2017 Soleno Therapeutics 10
Presented by Soleno 10th International Meeting of Pediatric Endocrinology 14 Sep 2017
-10
-8
-6
-4
-2
0
Overall
(n=11)
Moderate - Severe
Hyperphagia
(n=6)
Dose ≥ 4.2 mg/kg
(n=4)
Moderate - Severe
Hyperphagia,
Dose ≥ 4.2 mg/kg
(n=3)
M
e
a
n
Ch
a
n
g
e
f
ro
m
B
a
s
e
lin
e
p=0.0055
Placebo Reverses DCCR Treatment Effect
Patients with Moderate-Severe Hyperphagia
| © 2017 Soleno Therapeutics 11
-40%
-30%
-20%
-10%
0%
0 14 28 42 56 70 84 98
DCCR (n = 3) Placebo (n = 3)
Study Day
M
e
d
ia
n
P
e
rce
n
t
Ch
a
n
g
e
f
ro
m
B
a
s
e
lin
e
Visit 8
Visit 7
Hyperphagia Questionnaires
Comparison of HQ-CT to Modified Dykens Used in PC025
| © 2017 Soleno Therapeutics 12
Question
How upset did the person generally become when denied a desired food?
How often did the person try to bargain or manipulate to get more food at meals?
How often did the person forage through trash for food?
How often did the person get up at night to food seek?
How persistent was the person in asking or looking for food after being told “no” or “no more”?
How often did the person try to sneak or steal food (that you are aware of)?
Outside of normal meal times, how much time did the person generally spend asking or talking about food?
When others tried to stop the person from asking about food, how distressed did he or she generally appear?
How often did food-related behavior interfere with the person’s normal daily activities, such as self-care, recreation, school, or
work?
Once your child has food on their mind, how easy is it for you or others to re-direct your child away from food to other things?
How clever or fast is your child in obtaining food?
How variable is you child’s preoccupations or interests in food?
12
B
o
th
v
ersi
o
n
s
H
Q
-C
T
P
C
0
2
5
Response to 6 Common Hyperphagia Questions
2 Doses of Beloranib (ZAF-311) and DCCR (PC025)
| © 2017 Soleno Therapeutics 13
-2.0 -1.5 -1.0 -0.5 0.0
Upset when denied food
Bargain for food
Forage in trash
Up at night
Persistent asking for food
Steal food
Response by HQ-CT question
DCCR ≥ 4.2 mg BL ≥ 13 DCCR Overall B 2.4 B 1.8
Approximate comparison based on Figure 2a (Diabetes Obes Metab. 2017 May 29. doi: 10.1111/ dom.13021)
for beloranib and actual DCCR data (PC025 mean change from baseline-Visit 7)
mg mg
DCCR Impacts Body Fat and Lean Body Mass
| © 2017 Soleno Therapeutics 14
Presented by Soleno 10th International Meeting of Pediatric Endocrinology 14 Sep 2017
-2500
-1250
0
1250
2500
3750
M
e
a
n
Ch
a
n
g
e
f
ro
m
B
a
s
e
lin
e
(
g
)
Overall (n=11) Dose ≥ 4.2 mg/kg (n=4)
p=0.02
p=0.003
p=0.059
p=0.02
Body Fat
Lean Body Mass
0%
5%
10%
15%
20%
Overall Dose ≥ 4.2
mg/kg
M
e
a
n
P
e
rce
n
t
Ch
a
n
g
e
f
ro
m
B
a
s
e
lin
e
Lean Body Mass / Body Fat
Ratio
p=0.004
p=0.059
Waist Circumference
Significant Reduction from Baseline-V7
| © 2017 Soleno Therapeutics 15
• Reduction consistent with a loss of visceral fat.
106 108 110 112 114
Baseline (n = 11) Visit 7 (n = 11)
Waist Circumference (cm)
- 3.45 cm (p=0.006)
Presented by Soleno 10th International Meeting of Pediatric Endocrinology 14 Sep 2017
DCCR Reduces Aggressive Behaviors
| © 2017 Soleno Therapeutics 16
Presented by Soleno 10th International Meeting of Pediatric Endocrinology 14 Sep 2017
0 2 4 6 8
Screaming/Yelling
Throwing Objects
Aggressive/Violent Actions
Foul Language
Destructive
Threatens to Hurt Others
OVERALL
Baseline
Visit 7
Number of Subjects (n = 10)
p = 0.011
DCCR Impacts CV Risk Factors
| © 2017 Soleno Therapeutics 17
-0.6 -0.4 -0.2 0 0.2
Triglycerides
Total-C
LDL-C
HDL-C
Non-HDL-C
Mean Change from Baseline to V7 (mmol/L)
p=0.039
p=0.244
p=0.030
p=0.088
p=0.169
Presented by Soleno 10th International Meeting of Pediatric Endocrinology 14 Sep 2017
DCCR Safety
Consistent with Long History of Safe Use of Diazoxide
• Safety profile of Proglycem in chronic use is well-known
• In the development of DCCR, there have been no new
safety findings
– Most common adverse events include hyperglycemia and
peripheral edema
• Doses of DCCR that will continue in development are at
the low end or below the labeled range for Proglycem
• More than 120,000 patient-years of chronic use
| © 2017 Soleno Therapeutics 18
FDA Guidance Meeting (May 2017)
• FDA supported change in hyperphagia score (without a change in
weight) compared to placebo as the primary endpoint for the planned
Phase III study.
• Dosing paradigm proposed for the Phase III study was acceptable.
• FDA proposed and Soleno agreed that the duration of the randomized
double-blind placebo controlled study should be shorter
(3-4 months).
• Safety information about DCCR could be obtained in a long-term, safety
extension study.
• There was agreement on several other aspects of the study and the
overall development program, and additional regulatory input is being
sought on others.
| © 2017 Soleno Therapeutics 19
EMA Scientific Advice (September 2017)
• EMA support change in hyperphagia score compared to
placebo as the primary endpoint for the Phase III program
• Single Phase III study acceptable
• Treatment of children with hyperphagia acceptable
without additional toxicology study(ies)
• Dosing paradigm proposed was acceptable
• There was agreement on several other aspects of the study
and on the overall development program
| © 2017 Soleno Therapeutics 20
Phase III Proposed Study Design
• Patients will be randomized in a 2:1 ratio to DCCR or placebo
– Mod-severe hyperphagia, target dose ~4.2 mg/kg
• Expected study start Q4 2017, 9 - 12 months duration
• Primary endpoint – change in hyperphagia compared to placebo
• All patients completing C601 are eligible to enroll in C602
| © 2017 Soleno Therapeutics 21
3-4 months placebo-
controlled treatment
9-month open-label safety study
C601
~100 patients at
10-12 sites in the US
C602
• C601: Multi-center, randomized, double-blind, placebo-controlled, parallel
arm study in patients with PWS (Phase III)
• C602: Open label safety extension study
DCCR Estimated Development Timeline
| © 2017 Soleno Therapeutics 22
2017 2018 2019
CMC, Pharm/Tox, Clin Pharm
Phase III study
Open label
Extension
FDA guidance
meeting
NDA Submission
Topline data from Phase III
EMA
Scientific Advice
Extensive IP Protection
• Issued/Granted Patents
– US: 5; EU: 3; JP: 1;
– Also in China, India,
Canada and Australia
– Several pending
applications
– Expire in 2026 to 2035
– Covers composition of
matter, formulations,
combinations, method of
use and method of
manufacture
• Protection in PWS
– In addition to the
protection of the product,
our filings cover method of
use of any KATP channel
activator, diazoxide and
DCCR in PWS
– Newly issued patent based
on data from PC025
extends protection to 2035
| © 2017 Soleno Therapeutics 23
Pipeline – Orphan Opportunities
| © 2017 Soleno Therapeutics 24
Product Indication
US Population
Estimate
DCCR Prader-Willi syndrome 12,500 – 21,000a
Potential Upside Opportunities for DCCR
DCCR Hypothalamic Obesity 3,750 – 9,700b
DCCR Smith-Magenis Syndrome 12,500 – 21,000c
a Pediatrics 2011 127:195-204
b Front Endocrin 2011 2:1-8 & Orphanet J Rare Dis 2007 2:18
c Am J Hum Genet 1991 49(6):1207-1218
Orphan drug designation was granted for PWS in the US in May 2014
Hypothalamic Obesity
• Intractable weight gain and endocrine
complications following damage to the
hypothalamus
• Most frequently follows excision of a cranial
tumor, particularly craniopharyngioma
• Often evident within 1-2 months of surgery
• Dramatically reduced resting and
voluntary energy expenditure
• No currently approved treatments
• Prevalence 1:50,000, with more than 50%
being children and adolescents
| © 2017 Soleno Therapeutics 25
Weight change in adolescent
hypothalamic obesity patients treated for
6 months with diazoxide and metformin
Inter J Pediatric Endocrin 2011:417949
0
1
2
3
4
5
6
7
8
9
10
W
e
igh
t
Ch
a
nge
(
k
g
)
6 mo interval
prior to DZ trt
6 mo DZ-Met
treatment
N=9, p=0.004
Smith-Magenis Syndrome (SMS)
• Complex genetic neurobehavioral / metabolic
disorder due to haploinsufficiency of the retinoic
acid-induced 1 (RAI1) gene on chromosome
17p11.2
• Key aspects of the natural history parallels PWS
• Behavioral complications more prominent
• Highest unmet needs: aggressive behaviors,
hyperphagia, body composition and sleep
disturbances
• SMS families have low QOL
• There are no approved treatments
• Prevalence is 1:15,000 - 1:25,000
| © 2017 Soleno Therapeutics 26
2017 Priorities / Milestones
• 1Q17 – Closed merger transaction with Essentialis; completed
concurrent $10M financing
• May 2017 – Name change to Soleno Therapeutics
• May 2017 – Complete FDA guidance meeting for DCCR
• August 2017 – Complete EMA Scientific Advice
• 2H17 – Initiate Phase III clinical study evaluating DCCR for the
treatment of PWS
• 2017 – Explore strategic alternatives for legacy marketed
products and product candidates
– Sale of Neoforce
• 2017 – Secure orphan drug designation for DCCR in additional
indications and geographies
| © 2017 Soleno Therapeutics 27
Financial Highlights
1 Does not include holdback shares of 900 thousand to be issued after 1 year and
milestone shares of 4.6 million to be issued upon start of Phase III clinical trial
Cash runway to value creating milestones
(millions) 6/30/2017
Cash $7.5
Debt $0
Shares
outstanding:
Common 47.51
Fully-Diluted 65.41
| © 2017 Soleno Therapeutics 28
Investment Highlights
| © 2017 Soleno Therapeutics 29
Capnia and
Essentialis
Merger
Compelling
product profile
Addresses
hallmark
symptoms of PWS,
including
hyperphagia
Phase III ready
Established,
decades-long
safety profile
Strong IP
Financing
concurrent
with
completed
merger
Adequate to
advance DCCR
into Phase III
program
Multiple
downstream
orphan
indications
Hypothalamic
obesity, Smith-
Magenis
syndrome
New Lead
Asset DCCR
Financed
Through Key
Milestones
Longer-Term
Pipeline
Opportunities
Strong
Leadership
Highly
experienced
management
team
Expertise in drug
development for
rare and orphan
diseases
Creating a rare
disease
therapeutics
company
Initial focus on PWS,
a high unmet need
indication with no
approved
treatments
Merger completed