Investors presentation February 2017 Disclaimer 2 The information - - PowerPoint PPT Presentation
Investors presentation February 2017 Disclaimer 2 The information - - PowerPoint PPT Presentation
Investors presentation February 2017 Disclaimer 2 The information included in this presentation is a summary only and performance, or achievements to be materially different from those does not exhaust all of the information on the Company and
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Disclaimer
The information included in this presentation is a summary only and does not exhaust all of the information on the Company and its business, nor is it a substitute for inspection of the Periodic Report for 2015, the quarterly reports for 2016, the Company’s current reports and the presentations released thereby, as reported to the ISA via the Magna distribution site. The presentation does not constitute an
- ffering or an invitation to purchase securities of the Company, and
the provisions thereof do not constitute a recommendation or opinion
- r substitute for the discretion of the investor. The Company is not
responsible for the integrity or accuracy of the information. This presentation includes forecasts, estimates, assessments and other information pertaining to future events and/or matters, whose materialization is uncertain and is beyond the Company’s control, and which constitute forward-looking information, as defined in the Securities Law, 5728-1968. Such information may not materialize, in whole or in part, or may materialize in a manner significantly different to that forecast. Such information includes, inter alia, statements relating to our objectives, plans, and strategies; statements that contain projections of results of operations or of financial condition; statements relating to the research, development, and use of our technologies, products and product candidates; and all statements (other than statements of historical facts) that address activities, events, or developments that we intend, expect, project, believe, or anticipate will or may occur in the future. Forward-looking statements are not guarantees of future performance and are subject to risks and
- uncertainties. We have based these forward-looking statements on
assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. Important factors that could cause actual results, developments, and business decisions to differ materially from those anticipated in these forward-looking statements include, among
- ther things: the overall global economic environment; the impact of
competition and new technologies; general market, political, and economic conditions in the countries in which we operate; projected capital expenditures and liquidity; changes in our strategy; government regulations and approvals; litigation and regulatory proceedings. These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in the “Risk Factors” section and elsewhere in the Registration Statement on Form F-1 filed with the U.S. Securities and Exchange Commission and in the Periodical reports (in Hebrew) with the Israeli Security Authority and the Tel Aviv Stock Exchange. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this
- prospectus. These forward-looking statements speak only as of the
date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. The information presented was prepared according to the past experience and professional knowledge accumulated by the Company and in good faith. Such information is presented below for the sake of convenience only, but is not a substitute for the information provided by the Company in its financial statements or its immediate reports or in connection therewith, and therefore should not be relied on solely in itself. The information included in this presentation is similar to the information included in the reports and/or immediate reports of the Company and does not include new material information. However, some of the data included in the presentation are presented in a different manner and/or breakdown and/or are differently edited. In any event of inconsistency between the reports and/or immediate reports of the Company released to the public and the information contained in this presentation, the information released to the public as aforesaid shall prevail. All figures are approximate.
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Overview
- We are a regenerative medicine company focused on developing and
commercializing products for the orthobiologics and wound care markets
- Our technology allows the cost-efficient production of high quality
recombinant human collagen (rhCollagen)
- Our two lead products have received CE marking, and product launches
across Europe have been initiated
- We entered into an agreement with Arthrex, a leading orthopedic company,
for European distribution of VergenixSTR for the treatment of tendonitis
- We are co-developing a surgical matrix with Bioventus, a global leader in
active orthopedic healing, to address a $1.8 billion opportunity in spinal surgery and trauma
Yehiel Tal CEO
- Regentis
Biomaterials
- ProChon Biotech
- Kulicke & Soffa
Industries Oded Shoseyov Prof./Founder/CSO
- Pauli Clean Tech
- CBD Tech.
- Fulcrum-SPD
- Melodea
- Hebrew University
Eran Rotem CFO
- Tefron, CFO
(NYSE,TASE)
- Healthcare Tech.,
CFO (NASDAQ) &Gamida, CFO
- E&Y
Experienced management team
Philippe Bensimon VP RA/QA/CA
- Maquet-Getinge
- 3M Medical
Shomrat Shurtz
VP Commercialization
- Protalix
- BBDO Proximity
- Clal holdings
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Nadav Orr, PhD VP R&D
- Ethicon
Biosurgery, Johnson & Johnson Ilan Belzer COO
- BioHarvest
- Procognia Ltd.
- Omrix
Biopharmaceuticals
- Interpharm
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Surgical Matrix
Spine fusion & trauma
Soft Tissue Repair Matrix
Tendinopathy
Wound Filler
Chronic & surgical wounds
Wound care Orthopedics
$1.8B $2.0B $3.0B
Annual market potential
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Our products
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Field Product candidate Indications Annual market potential Stage of development
Commercialization
Upcoming milestones Discovery Preclinical Clinical Regulatory
Wound care
Chronic & surgical wounds $3.0B
Pre-IDE submission for Surgical Wounds indication
Orthobiologics
Tendonitis $2.0B
Commercialization in EU with Arthrex Pre-IDE submission
Orthobiologics
CollPlant Surgical Matrix Spine fusion & trauma $1.8B
IND submission (FDA) by Bioventus
3D Bioprinting
BioInk Cornea & cardiac patch Partnered Wholly-Owned
Europe US Europe US US
Pipeline with multiple value drivers
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Recent accomplishments and planned upcoming milestones
Recent accomplishments:
- Initial distributors established for VergenixFG and sales commenced
- Positive clinical results of VergenixSTR
- VergenixSTR CE mark received
- VergenixSTR distribution agreement with Arthrex for pan-European sales
- Commenced sales of VergenixSTR
Planned upcoming milestones:
- Sign Definitive agreement with Bioventus *
- Successful EU market launch of VergenixSTR (with Arthrex)
- Expansion of VergenixFG distribution network from 2 to 6 territories in EU
- Completion of EU Post Marketing Surveillance study with VergenixFG (50 subjects)
- Initiate FDA process (e.g. pre-IDE meeting) with VergenixSTR
- Signing new co-development agreement with a partner (e.g. BioInk, Orthopedics)
* While the co-development activity is ongoing, no license and supply agreement has been entered into and there can be no assurance that we
will enter into any definitive agreement with Bioventus. In anticipation of filing an IND, Bioventus is undertaking preclinical animal studies comparing the Collplant Surgical Matrix to other active comparators, and could decide to move forward with a competing product
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CollPlant’s technology: cost effective and scalable production
GROWING EXTRACTION PURIFICATION & FILLING END PRODUCT FABRICATION
Clean room facility Low cost space
Leaves Protein Concentrate Collagen PLANTLETS IN NURSERY Plant
Low cost scalable seed propagation
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kit
PRP collection tube from any commercial PRP Kit
Plasma Platelet-Rich Plasma Red Blood Cells
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Study results
Study Design
- Significant potential advantages over SoC
Clinical trial results
Study Results
- Single arm study
- 40 patients with tennis elbow (tendinopathy)
- One single treatment
- 3- and 6-month follow up
- End points – Safety; recovery in pain and motion as
measured through PRTEE, Quality of Life questionnaire and grip strength test
- f patients show clinical success at 3M
- f patients show clinical success at 6M
74% 86%
48% 36%
6M 3M
74% 86%
6M 3M
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Tendon repair - injectable rhCollagen/PRP matrix intended for treatment of partial or full
tendon tears
- Based on VergenixSTR technology
- Annual US incidents: ~400K
- RCR1, ACL2, Achilles3
rhCollagen-PRP clot
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Future opportunity for VergenixSTR
- 1. http://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-15-4
- 2. http://orthosurg.ucsf.edu/patient-care/divisions/sports-medicine/conditions/knee/anterior-cruciate-ligament-injury-acl/
- 3. http://www.uptodate.com/contents/achilles-tendinopathy-and-tendon-rupture
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kit
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Study results
Study Design
Clinical trial results
- 1. “The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of
a multicenter, controlled, randomized, blinded clinical trial,” Lavery et al, International Wound Journal, 2014.
Study Results
- Single arm study
- 20 patients with lower limb ulcer
- One single treatment
- 4 week follow up
- End points – Safety; wound reduction
- Average wound closure rate of 80%
- Full wound closure was observed in nine of the 20
patients (45%)
- Versus 24% of patients after 12 weeks with SoC1
- Full wound closure at 4 weeks after a single treatment
30% 62% 67% 80%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Week 1 Week 2 Week 3 Week 4
Mean Wound Closure Rate (%) over time (N=20 patients)
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Sales & marketing strategy: Europe first
- Due to rapid marketing clearance, Europe offers an opportunity to accelerate
revenue realization and develop a physician base of experience
- Utilize established distributors selling orthobiologics and wound care products
across Europe in key markets
- Undertake Post Marketing Surveillance (PMS) studies with KOLs generate
additional clinical data to support product sales and reimbursement
- Post Marketing Surveillance: 50+ cases to support conference presentations and peer-
reviewed journal submissions
- EMEA partnership with Arthrex extends potential for VergenixSTR beyond Europe
into Middle East & African markets
- FDA regulatory strategy informed by European regulatory and clinical experience
- Establish KOL network to support EU market penetration
- Strategic collaborations provide pipeline and market expansion opportunities,
leveraging partner infrastructure to drive adoption of rhCollagen
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CollPlant Surgical Matrix for bone repair Collaboration with Bioventus Inc.
* http://www.boneandjointburden.org/2014-report/iie1/spinal-fusion http://www.startribune.com/medtronic-s-infuse-widely-used-despite-cost-risks/49557847/
- We are party to a non-binding term sheet
entered into on July 2015 with Bioventus for the license and supply of the CollPlant Surgical Matrix
- The surgical matrix enables targeted and
controlled release of BMP-2 for accelerated bone formation
- Applications: spinal fusion and trauma
- Addressable market opportunity is projected to
be at least $1.8 billion (450,000 procedures*)
- The surgical matrix is co-developed by the
companies, with our aim to sign a Definitive Agreement in FY 2017
While the co-development activity is ongoing, no license and supply agreement has been entered into and there can be no assurance that we will enter into any definitive agreement with Bioventus. In anticipation of filing an IND, Bioventus is undertaking preclinical animal studies comparing the Collplant Surgical Matrix to other active comparators, and could decide to move forward with a competing product
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Future opportunity: BioInk
1 https://www.grandviewresearch.com/press-release/global-3d-bioprinting-market
rhCollagen-based BioInk for 3D bioprinting of tissues & organs
Market potential: $1B+ by 20221 CollPlant’s rhCollagen-based BioInk offers ideal characteristics for 3D bioprinting
Biocompatible – supports cell viability Controlled degradation profile Optimized viscosity and gelation kinetics Printed construct maintains physical properties compatible with natural tissue
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CollPlant IP portfolio
Patent Name Application # Priority Date Patent Status Collagen Producing Plants and Methods
- f Generating and Using Same
WO2006/035442 9/2004 Granted: USA(CIP), Europe, Europe(DIV-1), Europe(DIV-2allowed), Hong Kong ,Hong Kong(DIV) ,Canada, Japan Japan(DIV), Australia (DIV-1), Australia (DIV-2), Mexico, China, South Africa, , Singapore, India, Israel, New Zealand. Pending: USA (DIV), Brazil, Europe(DIV), India(DIV) Compositions Comprising Fibrous Polypeptides and Polysaccharides WO2009069123 11/2007 Granted: USA,USA(DIV-1), USA(DIV-2), USA(DIV- 3), Australia, Israel, Israel(DIV-Published), Europe Pending: USA(CON) Methods of Generating Collagen Fibers WO2011/064773 11/2009 Pending: Europe, USA, Hong Kong Methods of Generating and Using Procollagen WO2009/128076 4/2008 Granted: USA,Europe, Israel Pending:Canada, China(DIV), India, USA(CON) Methods of Processing Recombinant Procollagen WO2009/053985 10/2007 Granted: USA, Israel, Europe Compositions comprising collagen and PRP for tissue regeneration WO2014/147622 3/2013 Pending: USA, Europe, Canada, China, India, Israel Cross-linked Resilin-containing materials W2015/068160 1/2013 Pending: USA, Europe, Canada, China, India, Israel Adhesive biopolymers and uses thereof WO2013/030840 9/2011 Pending: USA, Europe, Israel
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