Corporate Presentation May 2017 - Zosano Pharma

Copyright © 2019 Zosano Pharma Inc. | Confidential

Corporate Presentation

November 2019


Forward-Looking Statements

2

This presentation contains forward-looking statements regarding Zosano’s technology and product candidates,

including ADAM, QtryptaTM and C213, and other future events and expectations. Readers are urged to consider

statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects,"

"potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "approximately" or the

negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject

to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include, without

limitation, risks and uncertainties associated with the process of discovering, developing and commercializing products

that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such

products and other risks and uncertainties described under the heading "Risk Factors" in the Company's most recent

quarterly report on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking

statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or

events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking

statements are based on information currently available to Zosano and Zosano assumes no obligation to update any

such forward-looking statements.


Zosano – Company Overview

3

Intracutaneous

Drug Delivery Platform

• Innovative application for delivery of Biologics

• Proteins

• Peptides

• Vaccines

Therapeutics

Opportunities

• Co-development

• Licensing

• Lead Program : Qtrypta™

• Acute migraine therapy

• Differentiated clinical data

• NDA filing expected in Q4 2019

• 2nd potential indication: clinical trial

enrollment underway for cluster headache

Opportunities

• Commercialization by Zosano

• Partnering

Proprietary Microneedle Patch Technology


Transforming How Drugs Get Delivered

4

Stratum corneum

Cellular epidermis

Coated patch in skin

Coated patch in skin

Novel

Novel transdermal patch containing drug-coated microneedles

Large & Small Molecules

Microneedles can be coated with both large and small molecules

Rapid & Consistent

Allows for rapid and consistent dissolution of drugs into capillary bed

Minimizes stimulation

Shallow depth of penetration of proprietary microneedles into superficial

skin layers designed to minimize stimulation of nerve endings

Convenient & Discreet

Quarter size patch designed to be convenient and discreet

Easy to Use

Patient experiences in trials have generally been positive and provide

evidence that the system is easy to use


Patch Application

5

Snap patch ring

assembly onto

applicator.

Twist applicator

cap from position

#1, to position #2 to

unlock for patch

application.

Press applicator

downward on skin

to apply.Patch is applied.

Remove spent patch ring to

apply subsequent patches.

1

2

3

4&5

Handheld, reusable applicator designed to ensure that the same force is applied across multiple

applications and is user independent.



6

Intracutaneous



• Proteins

• Peptides

• Vaccines

Therapeutics

Opportunities

• Co-development

• Licensing







Opportunities


• Partnering



▪Lead Program: Qtrypta™ (M207)

▪ Acute migraine therapy

▪ Novel

▪ Clinical studies completed

▪ Addresses unmet patient needs

▪ Expected NDA filing in 4th Quarter of 2019

7


Qtrypta – Completed Planned Clinical Development

Preclinical studies

▪ Published in Journal of Pharmaceutics – May 2018

▪ Published in Journal of Pharmaceutical Sciences – June 2018

Phase 1 – PK study

▪ Published in Pain Management – August 2017

Pivotal efficacy study

▪ Published in Cephalalgia – November 2017

Phase 3 – 12 month safety study

▪ Data presented at IHC – September 2019

NDA filing – On track for Q4 2019

▪ PK bridging study – completed

▪ Human factors study – completed

▪ Registration batch stability testing - completed

▪ Pre-NDA clinical meeting – completed

▪ Pre-NDA CMC written response from FDA expected in November 8


39 Million People in the US Suffer From Migraines

9

▪ 3rd Most Prevalent Disorder in the World▪ Impacts ~25% of U.S. Households ▪ Occurs in 12% of U.S. Population▪ 85% of Chronic Migraine patients are women

▪ $36B in Lost Productivity▪ $5.4B in Treatment Costs

Source: Migraine Research Foundation

PREVALENT

DEBILITATING

COSTLY

▪ 90% Unable to Function Normally▪ 1.2 MM ER Visits per Year▪ 25% of women experience 4+ Migraines/month▪ Attacks Last 4-72 Hours


10

MANY PATIENTS ARE DISSATISFIED AND WILLING TO TRY SOMETHING NEW

42%37%

50% 48%

39%

79%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Inadequatepain relief

Slow onsetof action

Recurrence/worsening of pain

Inability to function/work quickly aftertaking medication

Undesireableadverse events

Would be willing totry another acute

medication to treatthe headache

Source: Bigal ME et al. Headache. 2007;47:475-479.


41.5%

68.3%

14.3%

42.9%

0%

20%

40%

60%

80%

Pain Freedom MBS

% S

ub

ject

s A

chie

vin

g P

ain

Fre

edo

m o

r Fr

eed

om

fro

mM

BS

at 2

Ho

urs

Qtrypta 3.8mg Placebo

Need: Freedom from pain Statistically Significant Impact on Pain Freedom and MBS

11

p=<0.0001TG = 27.2

p=<0.0009TG = 25.4

ACHIEVEMENT OF CO-PRIMARY ENDPOINTS

Spierings ELH et al. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia 2018 Feb;38(2):215-224.TG = Therapeutic Gain (difference between Qtrypta and Placebo)


Need: Freedom from pain Need: Fast onset of action Pain Freedom: Over 48 Hours

12

7.3%

17.1%

26.8%

41.5%

51.2%54.9%

62.2%

69.5% 64.6%

0%

20%

40%

60%

30 minutes 45 minutes 1 hour 2 hour 3 hour 4 hour 12 hours 24 hours 48 hours% S

ub

ject

s A

chie

vin

g Pa

in F

reed

om

Pain Freedom 30 Minutes to 48 Hours

Qtrypta Placebo

*

**

**

****

**

****

Spierings ELH et al. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia 2018 Feb;38(2):215-224.

*p=<0.05 **p=0.01


13

23.2%

46.3%

56.1%

68.3%

80.5% 81.7% 82.9% 80.5%78.0% 78.0%

0%

20%

40%

60%

80%

15 minutes 30 minutes 45 minutes 1 hour 2 hour 3 hour 4 hour 12 hours 24 hours 48 hours

% S

ub

ject

s A

chie

vin

g P

ain

Re

lief

Pain Relief 15 Minutes to 48 Hours

Qtrypta Placebo

*

** ** ** ******

Spierings ELH et al. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine.

Cephalalgia 2018 Feb;38(2):215-224. *p=<0.05 **p=0.01

Need: Substantial pain relief Need: Fast onset of action~ 80% Of Patients Had Pain Relief Through 48 Hours


Need: No recurrence/absence of pain Qtrypta: Sustained Pain Freedom

14

31.7%26.8%

10.4% 9.1%

0%

10%

20%

30%

40%

2-24 Hours 2-48 Hours

Po

st-H

oc

An

alys

is %

of

Sub

ject

s w

ith

Su

stai

ne

d P

ain

Fre

ed

om

at 2

4 a

nd

48

ho

urs

Qtrypta 3.8mg Placebo

p=0.001 p=0.0035

Spierings ELH et al. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia 2018 Feb;38(2):215-224.

P-values are nominal

76% of patients who were pain free at 2 hours showed sustained pain freedom through 24 hours65% showed sustained pain freedom though 48 hours


Need: Ability to function/work quickly and consistentlyNeed: Eliminate hangover effectMigraine-ACT (Assessment of Current Therapy) Scores for Qtrypta

Proportion of participants who answered “Yes” at 48 weeks:

15

Question %

Does your migraine medication work consistently, in the majority of your

attacks?95%

Does the headache pain disappear within 2 hours?83%

Are you able to function normally within 2 hours?86%

Are you comfortable enough with your medication to be able to plan your

daily activities?93%

A total of 342 subjects received study drug, 335 treated at least 1 migraine, 257 completed 6 months of the study and 127 completed 1 year.

86% of subjects

were able to

function normally

at 2 hours

Migraine-ACT questionnaire: a standardized evaluation completed by patients to assess the effectiveness of a patient’s acute treatment of migraine therapy (Highest score 4.0)


Long Term Safety Results – Presented at IHC

Well Tolerated

• Most common AE was redness/swelling.

• 95% were mild and 80% resolved within 48 hours.

• Less triptan-like side effects than typically found with the class.

• Less than 2% of patients reported effects like dizziness and

paresthesia.

16


Target Market: Difficult to treat migrainesPublished in Headache – January 2019

17

Pain-Free 2 Hr MBS-Free 2 Hr

n(%)Placebo ADAM

Zolmitriptan 3.8 mg

P -Value* Placebo ADAM

Zolmitriptan 3.8 mg

P- Value*

Nausea/Vomiting (51) 14% (59) 44% 0.0005 (51) 45% (59) 68% 0.009

On Awakening (44) 16% (36) 44% 0.0056 (44) 39% (36) 72% 0.0031

Severe Pain (33) 15% (39) 26% 0.2489 (33) 42% (39) 64% 0.0376

Time To Treat ≥ 2hrs (40) 10% (36) 33% 0.0169 (40) 41% (36) 69% 0.0137

MBS: Most Bothersome Symptom *Nominal

▪ The rapid absorption observed in clinical studies of ADAM zolmitriptan may contribute to its potential to provide

pain- and MBS-freedom in many patients even when treatment is delayed.

▪ Intracutaneous administration may provide an additional advantage in patients with nausea by bypassing the

need for swallowing or inhaling medication.

▪ The efficacy results seen in this trial suggest that ADAM zolmitriptan may be more effective than other routes

of administration of triptans, particularly oral.

EFFICACY OF ADAM ZOLMITRIPTAN (INTRACUTANEOUS ZOLMITRIPTAN) FOR THE ACUTE TREATMENT

OF DIFFICULT-TO-TREAT MIGRAINES

Results

Conclusions


Qtrypta is Differentiated And Addresses Unmet Needs

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81% Pain Relief in 2 Hours

EFFECTIVEFAST

Peak Plasma Concentration in 15 Mins

COMPLETE SUSTAINED

41.5% Pain

Freedom in 2 Hours63% Sustained Pain

Relief From 2-48 Hours

Kellerman DJ, Ameri M, Tepper SJ. Rapid systemic delivery of zolmitriptan using an adhesive dermally applied microarray. Pain Management doi: 10.2217/pmt-2017-0036 (2017). Spierings ELH et al. Randomized,

double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia 2018 Feb;38(2):215-224.

41.5%

14.3%

Qtrypta 3.8 mg Placebo


0

20

40

60

80

100

0 0.5 1 1.5 2

Time, hZomig 5mg Oral Zomig 5mg Nasal Imitrex 6mg Inj Imitrex 100mg Tab M207

Qtrypta™ (M207)

Qtrypta Is Well Positioned Against Current Triptans

19

PAIN RELIEF OVER TIME1 (REFERENCE COMPOUNDS)

1. Comparisons are not based on data resulting from head-to-head trials and are not direct comparisons of safety or efficacy. Different protocol designs, trial designs, patient selection and population number of patients, trial endpoints, trial

objectives and other parameters that are not the same between the relevant trials may cause any comparisons of results from different trials to be unreliable.


Positioning Against New Entrants

20

41.5%

32.2%

38.8%

19.2% 19.6% 20.7% 21.8% 21.2%

34.3%

51.0%

68.3%

40.7%

48.7%

36.6% 37.6%

34.1%

38.9% 37.7%

64.1%

0%

20%

40%

60%

Qtrypta Lasmiditan 200mgSamurai study

Lasmiditan 200mgSpartan study

Rimegepant 75 mg301 study

Rimegepant 75 mg302 study

Ubrogepant 25mg Ubrogepant 50mg Ubrogepant 100mg Onzetra Xsail - nasal Zembrace 3 mg -injectable

% o

f Su

bje

cts

ach

ievi

ng

Pai

n F

ree

do

m a

nd

MB

S Fr

ee

do

m a

t 2

Ho

urs

Comparison of Pain Freedom and MBS Freedom at 2 Hours1

Pain Freedom MBS

2

1. Comparisons are not based on data resulting from head-to-head trials and are not direct comparisons of safety or efficacy. Different protocol designs, trial designs, patient selection and population number of patients, trial

endpoints, trial objectives and other parameters that are not the same between the relevant trials may cause any comparisons of results from different trials to be unreliable.

2. Onzetra Xsail was not tested for MBS Freedom


Qtrypta Well Positioned Against New Entrants

21

81.0%

59.0% 56.0% 58.1%61.0% 67.6% 60.0%

0%

20%

40%

60%

80%

Qtrypta Lasmiditan 200mg Rimegepant 75 Samurai study mg 301 study

Rimegepant 75mg 302 study

Ubrogepant 100mg

Onzetra Xsail -nasal

Zembrace 3 mg -injectable

% S

ub

ject

s A

chie

vin

g P

ain

Rel

ief

at 2

Ho

urs

Comparison of Pain Relief at 2 Hours1

1. Comparisons are not based on data resulting from head-to-head trials and are not direct comparisons of safety or efficacy. Different protocol designs, trial

designs, patient selection and population number of patients, trial endpoints, trial objectives and other parameters that are not the same between the relevant trials may cause any comparisons of results from different trials to be unreliable.

Portfolio Expansion

Copyright © 2019 Zosano Pharma Inc. | Confidential22


Significant Unmet Need in Cluster Headache

▪ Highly disabling chronic neurological condition1

▪ Recognized as most severe pain known to humans

▪ 15%-22% have suicidal ideations2

▪ Short-lasting headache attacks characterized by3:

▪ Severe unilateral temporal/orbital pain

▪ Ipsilateral autonomic symptoms

▪ Lasting 15–180 minutes (when untreated)

▪ Sense of restlessness or agitation

▪ Prevalence of cluster headache

▪ Approximately 1 in 1000 (0.12%) suffer from the condition

▪ Prevalence similar to Parkinson's and Multiple Sclerosis4,5

▪ Over 300,000 people suffer from cluster headache in the US

23

1. Jürgens T, Gaul C, et al. Impairment in episodic and chronic cluster headache. Cephalalgia 2010; 31:671–682.2. Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache 2012;52:99-113. 3. Headache Classification Committee of the International Headache Society (IHS). The International

Classification of Headache Disorders, 3rd edition. Cephalalgia 2018: 38, 1–211. 4. Fischera M, Marziniak M, Gralow I, Evers S. The incidence and prevalence of cluster headache: a meta-analysis of population-based studies. Cephalalgia 2008;28:614-8. 5.

Ford HL, Gerry Em Johnson M et al. A prospective study of the incidence, prevalence and mortality of multiple sclerosis in Leeds. J Neurol 2002; 249:260-5. 6. Klapper, et all, (2011) Cluster Headache. Headache, Face, Neck Pain Science, Evaluation and Management. Retrieved from https” books.Google.com.


Cluster Headache (C213): Clinical Trial Program

24

Cluster Patients: 120

Population: Chronic or episodic cluster headache sufferers

Design:Each cluster headache sufferer will take a single dose to treat a qualifying

headache

Dosing: 1.9 mg, and 3.8 mg vs placebo (1:1:1)

Co-primary Endpoints:• Proportion of subjects with pain relief at 15 minutes

• Proportion whose pain relief is sustained from 15 minutes to 60 minutes

IND filed in August 2019

Phase 2/3 Clinical Trial Design



25

Intracutaneous



• Proteins

• Peptides

• Vaccines

Therapeutics

Opportunities

• Co-development

• Licensing







Opportunities


• Partnering



Future: Intracutaneous Delivery Biologics

▪ Original focus of Intracutaneous drug delivery

▪ Demonstrated delivery

▪ Proteins

▪ Peptides

▪ Vaccines

26


Opportunity: Vaccines Consistent delivery at target site may ensure optimal immune response

▪ Antigen-coated microneedles delivery

directly to epidermal/dermal skin layers

rich in AP cells

▪ Designed to improve immune response

▪ Designed to be less adjuvant

▪ Microneedle coating designed to

accommodate vaccine proteins,

glycoconjugates, microparticles and DNA

▪ Dry-coated formulation designed to

provide antigen stability and rapid

dissolution in skin interstitial fluid

27


Vaccines: Results from Phase 1 study

▪ Zosano trivalent flu patch vs. commercial IM vaccine

▪ Targeted fold titer increase and seroprotection ▪ Comparable immune response with only a 5-minute patch wear time 28


Experienced Management Team

29

Name Title Experience

Steven Lo Chief Executive Officer

Donald Kellerman, PharmDVP, Clinical Development &

Medical Affairs

Greg Kitchener Chief Financial Officer

Hayley Lewis SVP, Operations

Dushyant Pathak, PhD SVP, Business Development


Board of Directors

30

Name Title Experience

John P. Walker Chairman, Zosano Pharma

Steven Elms Managing Partner, Aisling Capital

Linda Grais, MD, JD Director, Zosano Pharma

Kenneth R. Greathouse Director, Zosano Pharma

Joseph HaganPresident and Chief Executive

Officer, Regulus Therapeutics Inc.

Steven LoChief Executive Officer, Zosano

Pharma

Kleanthis G. Xanthopoulos, PhDPresident and Chief Executive

Officer, IRRAS AB

Documents

Corporate Presentation May 2017 - Zosano Pharma