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| 8-K - FORM 8-K - Zosano Pharma Corp | d939689d8k.htm |
 Corporate Presentation
June 2015 Exhibit 99.1 |
 Forward-Looking Statements
1 This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding our commercialization, our research and other development programs, our ability to undertake certain activities and accomplish certain goals, projected timelines for our research and development activities (including any clinical trials), our ability to secure and further possible regulatory approvals, the enforceability of our intellectual property rights, our capital requirements, the prospects for third-party reimbursement for our products, the expected pricing of our products, our expectations regarding the relative benefits of our product candidates versus competitive therapies, our expectations regarding the possibility of licensing or collaborating with third parties regarding our product candidates or research, our business strategy, our expectations regarding potential markets or market sizes, and our expectations regarding the therapeutic and commercial potential of our product candidates, research, technologies and intellectual property, are forward-looking statements. In some cases, you can identify these statements by forward-looking words, such as the words “believe,” “may,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “potential” and similar expressions, as well as the negative version of these words and similar expressions. The forward-looking statements in this presentation do not constitute guarantees of future performance. Statements in this presentation that are not strictly historical statements are subject to a number of known and unknown risks and uncertainties that could cause actual results to differ materially and adversely from those anticipated or implied in the forward-looking statements, including, without limitation, those described under the heading “Risk Factors” in our Form 10-K filed with the SEC on March 26 , 2015, and new risks emerge from time to time. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties which include, without limitation, risks associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics and risks inherent in the effort to build a business around such products. Although we believe 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. Any forward-looking statement made by us in this presentation speaks only as of the date this presentation is actually delivered by us in person. We assume no obligation or undertaking to update or revise any forward-looking statements contained herein to reflect any changes in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, except as required by law. |
 Zosano Pharma Drug Delivery System
Convenient and Easy-to-Use
2 : |
 Zosano approach provides rapid onset
Hydrophilic drug formulation coated on tips of microneedles
Microneedles
are 200-350 microns long – close proximity to capillary bed Formulation quickly dissolved by interstitial fluid for short Tmax 3 Rapid Onset and High Bioavailability Zosano Pharma Drug Delivery System |
 Zosano Pharma Drug Delivery System
Formulations Stable at Room Temperature
4 Higher product stability, longer shelf life vs. injectables requiring refrigeration
Dry, hydrophilic formulation of ZP-PTH more stable than Forteo liquid
injectables Packaging purged with nitrogen –
no moisture or oxygen ensures product stability
Demonstrated 36 month shelf life at room temperature for
ZP-PTH 80
85 90 95 100 0 5 10 15 20 25 30 35 40 Storage Time (months) Phase 2 Zosano PTH 40 mcg vs. Forteo ZP-PTH 3 yr RT Stable Forteo (2-8 o C) Forteo RT |
 Broad ZP-Patch Compatibility Across Molecule Types
Rapid Onset Significant Criterion for Molecule Prioritization
5 Technical Feasibility With 30+ Compounds Screening Criteria Prioritized for Development Daily ZP-PTH ZP-Glucagon ZP-Triptan GLP-1 Analog Rapid onset provides therapeutic advantage High price per unit and substantial market size Preferably short clinical development Partnership opportunities on a case-by-case basis Preclinical Phase 1 Phase 2 Daily PTH Weekly PTH BNP Desmopressin Insulin LHRH Glucagon Cyclosporin A EPO Exenatide G-CSF GLP-1 Analog GRF Analog hGH Octreotide Oligonucleotide (antisense ICAM) Pentosan Polysulfate (Elmiron) Undisclosed Monoclonal Antibody VEGF Epinephrine Fentanyl Granisetron Naratriptan RWJ-445167 (JNJ NCE) Sumatriptan Zolmitriptan Influenza Diphtheria Lyme Disease Plasmid DNA Vaccine (Hep B) Plasmid DNA Vaccine (Muc1) Tetanus |
 Zosano Pharma (ZSAN)
Differentiated transdermal microneedle ZP-Patch delivery
platform Capable of delivering small molecules, peptides/proteins
and vaccines Fast onset with short Tmax: injection-comparable
or better Convenient and easy-to-use: room temperature
stable, portable Well validated pipeline with multiple near term
catalysts ZP-PTH entering Phase 3 for osteoporosis – Phase 3 start Q1 2016 – partnered ZP-Glucagon for severe hypoglycemia emergency rescue – Phase 2 data Q3 2015 ZP-Triptan (zolmitriptan) for migraine – Phase 1 data Q4 2015 GLP-1 analogues
for type 2 diabetes – partnered Robust IP and life cycle management options across entire portfolio Cash and cash equivalents (as of 3/31/15) of $55.9 million Sufficient to fund operations through mid-2016 6 Investment Highlights |
 ZP-Glucagon Severe hypoglycemia Development Pipeline Multiple Upcoming Milestones 7 Preclinical Phase 1 Phase 2 Phase 3 Daily ZP-PTH Osteoporosis ZP-Triptan Migraine Weekly GLP-1 Type 2 diabetes Undisclosed Multiple P2 Started Q1 2015 Ph3 Start Q1 16 Ph2 Data Q3 15 Ph1 Data Q4 15 Completed Upcoming Milestone LEGEND: |
 Overview of ZP-PTH Collaboration with Eli Lilly
Exclusive worldwide ZP-PTH license to Lilly
Zosano responsible for Phase 3 clinical development, regulatory approvals
and commercial readiness
Lilly responsible for commercialization activities
Attractive deal terms with $300 million on product approval
$15 million equity investment in private placement concurrent with
IPO $300 million at regulatory approvals
$125 million upon sales milestones
Double-digit royalty
Zosano to be exclusive supplier of commercial material
Confidential
8 Attractive Partnership with PTH Market Leader |
 6 month, five arm, multi-national BMD trial
165 post-menopausal women with low bone density
20 µg, 30 µg, 40 µg patches with Forteo
and placebo as comparators
Daily dosing self-administered by patients
Primary endpoint: Increase in spine BMD
Secondary endpoint: Increase in hip BMD
9 Clinical Trial Design for Completed Phase 2 Study N = 165 0 Month 1 Month 3 Month 6 ZP-Patch Placebo Month 4 ZP-PTH 30mcg qd ZP-PTH 20mcg qd Forteo 20mcg qd Screening Primary/Secondary Endpoint ZP-PTH 40mcg qd Month 5 Month 2 Daily ZP-PTH Patch Program for Osteoporosis |
 Daily ZP-PTH Patch Program –
Phase 2 PK Profile
Achieved dose proportionate and pulsatile pharmacokinetics
Variability in patch doses comparable to Forteo injectable
10 Pulsatile Delivery Critical for Building Bone PK OVER TIME MEAN AUC BY DOSE HOURS |
 Daily ZP-PTH Patch Program –
Phase 2 BMD Data Higher Hip BMD Gains vs. Forteo 11 HIP BMD SPINE BMD (0.634%) 0.138% 0.553% 1.331% 0.094% Increase in BMD (%) (0.330%) 2.960% 3.470% 4.970% 3.550% Increase in BMD (%) ZP-PTH 20µg ZP-PTH 30µg ZP-PTH 40µg FORTEO 20µg Placebo Placebo ZP-PTH 20µg ZP-PTH 30µg ZP-PTH 40µg FORTEO 20µg Ref: Cosman et al JCEM, 2010 All active treatments vs Placebo p=<0.001 vs. ZP- Placebo 95% CI = 0.595 – 2.755 vs. Forteo 95% CI = 0.077 – 2.386 |
 Daily ZP-PTH for Osteoporosis
Single, non-inferiority Phase 3 trial comparing Daily ZP-PTH to
Forteo
with 505(b)(2) regulatory pathway
Phase 3 is a larger and longer version of successful Phase 2
study Primary endpoint: Non-inferior change in spine BMD at 12
months 400 postmenopausal women per arm
Secondary endpoint: change in hip BMD at 12 months
Six month safety extension
Long-term fracture study not required
Past discussions with FDA and European authorities
Regulatory confirmation of protocol details expected in Q3 2015 Manufacturing scale-up
and commercial readiness ongoing Significant clinical study
inventory expected Q4 2015
12 Planned Phase 3 Trial Design |
 ZP-Glucagon for Severe Hypoglycemia
Severe hypoglycemia is life-threatening, requiring emergency
rescue Ease-of-use critical for third-party
caregivers who may lack medical training Rapid onset important
for fast recovery Underpenetrated market generates ~$160 million in
US sales Only two glucagon products currently marketed in
U.S. High current unit selling price in U.S. (>$150 per
injection) Concentrated prescriber base
Current glucagon injections are cumbersome with poor stability
Dry powder needs to be reconstituted at time of injection
Route of administration limited to injection/infusion
Efficient clinical development pathway
Clinical development expected to be complete by
2016 with estimated remaining spend of $7 million 13 Potential to Expand Highly Underserved Market |
 Complex, multi-step reconstitution,
third party administered
Significant prep time
Press-and-Apply pre-loaded
disposable system
Fast, simple, no prep needed
Unstable formulation
Stable, dry patch formulation
Short shelf life after reconstitution
No reconstitution required
Treatment Time Critical for Emergency Rescue
Current Products Not User-Friendly
14 Zosano Solution Currently Marketed Product |
 Formulation Stability a Significant Competitive Advantage
Stability Demonstrated at 40°
C over Six Months
15 95 96 97 98 99 100 0 1 2 3 4 5 6 7 Months ZP-Glucagon Patch Stability Formulation C 25C Formulation C 40C Formulation D 25C Formulation D 40C |
 ZP-Glucagon –
Phase 1 PK Data vs. Injection
20 subjects tested in five-way crossover study
16 Short Tmax, High Bioavailability, and Low Variability Across Doses |
 ZP-Glucagon –
Phase 1 Glucose Data vs. Injection
PD for All Patch Doses Comparable to Injection
17 Patch C, upper arm Patch C, forearm Patch C, abdomen Patch D, abdomen IM glucagon injection |
 ZP-Glucagon for Severe Hypoglycemia
Launch Gen 1 product using reusable applicator
Phase 1 completed Q1 2014; received FDA feedback regarding development
plan H2 2014
Phase 2 trial to compare patch vs. injection in diabetic patients with
induction of hypoglycemia (16 patient crossover) commenced in Q1
2015 Phase 3 trial to compare patch vs. injection in diabetic
patients with induction of hypoglycemia (~100 patients) after
the completion of the Phase 2 trial Develop Gen 2 product using
single-use applicator and integrated patch by leveraging
ZP-Triptan development work 18
Next Steps |
 ZP-Triptan for Migraine
Potential best-in-class rapid onset: Tmax = 9 minutes
Comparable or better onset of action than existing
triptans/injectables Self-administration provides significant
advantage vs. injectables Large, growing market with attractive unit
pricing for injectables US $1.9 billion total migraine market
($1.1 billion for triptans) Multiple products in a large and
growing market but no clear, effective solution
Phase 1 PK data vs. injection expected Q4 2015
19 Highly Suited for Acute Condition Requiring Immediate Relief |
 ZP-Triptan for Migraine
Demonstrated High Bioavailability with Rapid Onset
20 Route Dose (mg/kg) Tmax (min) AUC (ng*h/mL) Cmax (ng/mL) Abs BA % (dose norm) ZP-Triptan 1 1.81 9 296 ± 106 587 ± 256 100 IV 1.26 1 203 ± 27 1,103 ± 92 N/A 1. 3cm² patches coated with 800mcg / patch 0 200 400 600 800 1,000 1,200 1,400 0 30 60 90 120 150 180 Time, min IV Patch |
 Rapid Onset Associated with Pain Relief
ZP-Triptan With Potential Best-in-Class Onset of Action
21 Products Included: (1) Nasal:
Imitrex (sumatriptan), Zomig (zolmitriptan) Oral—Melt:
Zomig-ZMT (zolmitriptan) Maxalt-MLT (rizatriptan)
(2) Oral—
Tablets: Imitrex (sumatriptan), Treximet (sumatriptan/naproxen sodium), Zomig (zolmitriptan) Maxalt (rizatriptan), Amerge
(naratriptan), Axert (almotriptan), Frova (frovatriptan), Relpax (eletriptan) (3) Subcutaneous:
Sumavel DosePro (sumatriptan injection), Imitrex (sumatriptan injection) (4) T max achieved in preclinical testing (5) Average T max represents overall average of the midpoint of the range for all products.
(6) Average relief at 2 hours represents overall average of the midpoint of the
range for all products. Range reflects headache relief data obtained in placebo controlled clinical studies, which include different doses of the same triptan. Nasal / Oral Melt (1) Oral Tablets (2) Patch Zecuity Subcutaneous Injection (3) ZP-Triptan (4) T max (Ave) (5) (H:MM) Pain Relief 2 hours (6) (Ave) To be evaluated 75% 63% 57% 53% |
 ZP-Triptan for Migraine
Launch product using current applicator and patch
Phase 1 data expected in Q4 2015
Single/multi dose crossover study versus SC/IM injection
Multiple patch doses with zolmitriptan compared to one subcutaneous
injection of sumatriptan in healthy volunteers
Phase 2 trial with 200 patients planned
Expected to compare three ZP-Triptan doses vs. placebo
Primary endpoint: reduction in headache severity in 2 hours or
less Subcutaneous sumatriptan injection as reference
arm 22
Next Steps |
 Zosano grants Novo Nordisk exclusive rights to develop patch formulations of Novo GLP-1 analogs Large, growing market: 2014 U.S. GLP-1 sales 1 > $3 billion USD Novo/Victoza 2014 TRx market share >60% 2 Worldwide collaboration on multiple Novo GLP-1 analogs Novo Nordisk responsible for all development and commercialization Reimbursement of all Zosano development and manufacturing costs Preclinical, clinical, regulatory and sales milestones to Zosano Up to $60 million total for first product and $55 million for each additional
Zosano eligible to receive royalties on sales
23 Exclusive Partnership with Novo Nordisk in Blockbuster Market Once-Weekly GLP-1 Patch for Type 2 Diabetes * GLP-1 market includes Victoza (liraglutide), Byetta/Bydureon (exenatide), Tanzeum (albiglutide), and Trulicity (dulaglutide)
** Source: IMD NPA MAT, as reported by Novo Nordisk |
 ZP-Patch Intellectual Property
Issued Patents (owned & licensed) = 22 US, 12 EU, 13 JP
24 Patent Protection Until 2027 ZP Technology Platform ZP Technology Platform Transdermal & PTH Formulation/ Coating/PK/PD 7 US, 3 EU, 5 JP Transdermal & PTH Formulation/ Coating/PK/PD 7 US, 3 EU, 5 JP Micro Projection Design & Anchoring to Skin 4 US, 2 EU, 2 JP Micro Projection Design & Anchoring to Skin 4 US, 2 EU, 2 JP Patch Applicator 5 US, 4 EU, 3 JP Retainer Ring & Delivery Control 3 US, 3 EU, 2 JP Patch Applicator 5 US, 4 EU, 3 JP Retainer Ring & Delivery Control 3 US, 3 EU, 2 JP Mfg & Packaging 3 US, 1 JP Mfg & Packaging 3 US, 1 JP |
 Zosano Pharma (ZSAN)
Differentiated transdermal microneedle ZP-Patch delivery
platform Capable of delivering small molecules, peptides/proteins
and vaccines Fast onset with short Tmax: injection-comparable
or better Convenient and easy-to-use: room temperature
stable, portable Well validated pipeline with multiple near term
catalysts ZP-PTH entering Phase 3 for osteoporosis – Phase 3 start Q1 2016 – partnered ZP-Glucagon for severe hypoglycemia emergency rescue – Phase 2 data Q3 2015 ZP-Triptan (zolmitriptan) for migraine – Phase 1 data Q4 2015 GLP-1 analogues
for type 2 diabetes – partnered Robust IP and life cycle management options across entire portfolio Cash and cash equivalents (as of 3/31/15) of $55.9 million Sufficient to fund operations through mid-2016 25 Investment Highlights |
 Corporate Presentation
June 2015 |