bstg biostage, inc. investor presentation
TRANSCRIPT
Investor Presentation2016
Forward Looking Statements
This presentation contains forward-looking statements within the meaning of the federal securities laws. You can identify these statements by our use of such words as “may,” “will,” “should,” “could,” “would,” “guidance,” “objectives,” “optimistic, “
“future,” “expects,” “plans,” “aim,” “anticipates,” “estimates,” “continue,” “drive,” “strategy,” “think,” “potential,” “potentially,” “growth,” “long-term,” “projects,” “projected,” “predicts,” “intends,” “believes,” “goals,” “sees,” “seek,” “develop,” “possible,” “is
likely,” “permit,” “new,” “emerging,” “opportunity,” “continue,” “pursue” and similar expressions that do not relate to historical matters. Forward-looking statements in this presentation may include, but are not limited to, statements or inferences about the
Company’s or management’s beliefs or expectations, the Company’s current products or products in development, the Company’s anticipated regulatory approvals, the Company’s business strategy, the outlook for the life sciences industry and the
fields of biotechnology and regenerative medicine, future revenues and earnings, the strength of the Company’s market position, business model and intellectual property rights, opportunities or potential opportunities in the fields of biotechnology and
regenerative medicine and related markets, the success of treatments utilizing the Company’s products, the market demand and opportunity for the Company’s current products, or the products it is developing or intends to develop and the Company’s
plans, objectives and intentions that are not historical facts.
These statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed
or implied by the forward-looking statements. Factors that may cause the Company’s actual results to differ materially from those in the forward-looking statements include the success of the Company’s pre-clinical development efforts, clinical trials and
other product development programs and the number of patients who can be treated with its products; the Company’s ability to access debt and equity markets to raise or obtain needed funding; the Company’s ability to obtain regulatory approvals,
including in the U.S. and the EU, for the Company’s products, including those utilizing its Cellframetm implant technology; the amount and timing of costs associated with the Company’s development of its products; the Company’s failure to comply with
regulations and any changes in regulations; the Company’s failure to effectively commercialize or market our products on a timely basis or at all; lack of demand or decreased demand for the Company’s products; the Company’s liability exposure
relating to our products; the current size or anticipated size of the regenerative medicine or biotechnology markets; the existence and size of opportunities in the regenerative medicine or biotechnology markets; the Company’s financial position and
ability generate revenues and profits; unpredictable difficulties or delays in the development of new technology; the performance of the Company’s collaborators and the Company’s collaborators not devoting sufficient time and resources to
successfully carry out their duties or meet expected deadlines; the Company’s ability to attract and retain qualified personnel and key employees and retain senior management; the availability and price of acceptable raw materials and components
from third-party suppliers; difficulties in obtaining or retaining the management and other human resource competencies that the Company needs to achieve its business objectives; increased competition in the fields of regenerative medicine and
biotechnology and the financial resources of the Company’s competitors; the Company’s ability to obtain and maintain intellectual property protection for its device and product candidates; the Company’s inability to implement its growth strategy; public
perception and ethical issues surrounding the use of cell technologies; the Company’s ability to operate without infringing on others’ intellectual property; potential costs of any lawsuits to protect or enforce its intellectual property; economic, political
and other risks associated with international revenues and operations and additional costs of complying with changes in regulatory rules applicable to public companies; plus factors described under the heading “Item 1A. Risk Factors”, in the
Company’s Annual Report on Form 10-K filed with the SEC in March 2016 or described in the Company’s other public filings. The Company’s results may also be affected by factors of which the Company is not currently aware. The Company may not
update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information. Except as
otherwise noted herein, any forward looking statements represent our estimates as of March 31, 2016 and should not be relied upon as representing our estimates as of any other date.
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A NewBeginning
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Financial Snapshot
• NASDAQ capital market listed: BSTG ticker symbol
• Market cap approximately $23m as of 3.30.16
• $7.5m cash on-hand as of 12.31.15 Approximately 14m shares outstanding; no debt or warrants
• Share purchase facility with Aspire Capital
• Top institutional holders as of 09.15: Prosight, State of NJ Pension, Blackrock, Vanguard, Dimensional
• Cash burn: $1.7-2.4m range per quarter last 4 quarters ended 12.31.15
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Leadership Team
Jim McGorry, MBACEO
Tom McNaughton, CPACFO
Saverio La Francesca, MDCMO
Laura MondanoVP, Regulatory Affairs
Seasoned life science executive with more than 30
years of leadership experience in medical
technology and biotechnology businesses.
Prior: Genzyme, Champions Oncology,
Baxter Healthcare
Experienced financial executive with a background that spans
start-ups, large enterprises and investment groups.
Prior: Harvard Bioscience, Cabot Corporation, Tivoli, Deloitte
Cardiothoracic surgeon: performed over 200 organ transplants.
Prior: DeBakeyHeart & Vascular Center,
Texas Heart Institute
Currently a collaborator with U. Texas Medical Branch Lung Regeneration Research Team
Regulatory affairs expert with more than 20 years experience
supporting development, commercialization and post-
approval life-cycle management.
Prior: Histogenics Corporation, Genzyme, Anika Therapeutics,
Boston Scientific
Regulatory Affairs Certified
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Highlights
2016: value Inflection year.Plan to file IND to conduct clinical
trials.
1 2 3
Addressing life-threatening conditions of the esophagus,
bronchus and trachea.
Proprietary Cellframe™ technology generating
first-in-classCellspan™ implants.
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2016 Highlights
Q42015
Q12016
Q42016
Q32015
Q22016
INDsubmission to
conduct clinical trials
Orphan drug submissionand Pre-IND meeting with
FDA
Progress on the ongoing preclinical study
collaboration with Mayo
BIOSTAGE™A new beginning
Positive preclinical data
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Cellframe Technology
PROPRIETARY
PERSONALIZED
VERSATILE
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Unmet Medical Needs
~8,000 patientsin US & EU
High complication ratesrequiring multiple interventions.
Tracheal Cancer, Stenosis and Trauma
40,000 new cases a year in USsimilar to colorectal and breast
Complication rates as high as 50%.
Non Small Cell Lung Cancer (NSCLC)
17,000 new cases a year and 15,000 US deaths
One of the worst cancers.Limited alternatives.
Esophageal Cancer
Sub-Optimal Existing Standards of Care
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Cellspan Esophageal Implants
Current Treatment • Complex surgical resection requiring
stomach and /or intestinal “pull up” to create replacement esophagus.
Unmet Need • High rate of complications, low
quality of life and impact on mortality.
Number of Patients • ~15,000.
Call Point • Thoracic, oncology and ENT
surgeons.
Potential Benefits
• Eliminates reliance on stomach and/or intestine to create mock esophagus.
• Reduces surgical complications and improves post surgical morbidity and mortality.
• May expand population to patients who are not fit for surgery and provide improved quality of life outcomes.
• Lowers costs through reduced hospitalization and in-hospital morbidity rates.
The Cellspan implant aims to improve outcomes for patients by simplifying surgical technique to reduce post- op complications, improve quality of life and restore function of the patient’s own esophagus.
Cellspan Esophageal Implant Opportunity
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Cellspan Bronchial Implants
Current Treatment • Pneumonectomy involves
removal of lung and 50% reduction of lung capacity.
Unmet Need • Highly complex procedure,
high rate of complications and loss of lung.
Number of Patients • ~5,000.
Call Point • Cardiothoracic surgeons.
Potential Benefits
• Preserves the lung.
• Improves morbidity and mortality rates.
• Allows for the safe reattachment/ reconnection of the main airways.
• Restores use of lung and improves patient quality of life.
• Lowers costs through reduced hospitalization and in-hospital morbidity rates.
The Cellspan implant aims to repair the bronchus without sacrificing the lung, and without debilitating outcomes and complications.
Cellspan Bronchial Implant Opportunity
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Cellspan Tracheal Implant Opportunity
Cellspan Tracheal Implants
Current Treatment
• Tracheal resection with no ability to preserve tracheal length and function.
Unmet Need • High rate of complications
and mortality.
Number of Patients • ~8,000 in US and Europe.
Call Point • Thoracic and ENT surgeons.
Potential Benefits
• Safer surgical intervention.
• Allows for reconstruction of any portion of the trachea affording improved survival and fewer complications.
• May expand population to patients who are not fit for surgery and provide improved quality of life outcomes.
• Lowers costs through reduced hospitalization and in-hospital morbidity rates.
The Cellspan implant aims to restore tracheal integrity and function with the hope of improved mortality and reduced long term complications.
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Cellspan Implants may radically improve treatment options
Total Revenue opportunity exceeds $1.5 Billion
~8,000 patientsin US & EU
Reconstruct any portion of the trachea, to restore function with the Cellspan Tracheal Implant
Tracheal Cancer, Stenosis and Trauma
Affecting bronchus~5,000 Patients in US & EU
Restore airway function, sparing a lung with the Cellspan Bronchial
Implant
Non Small Cell Lung Cancer (NSCLC)
Stage I & II diagnosed~15,000 Patients in US & EU
Restore nativeesophagus function with the
Cellspan Esophageal Implant
Esophageal Cancer
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Cellspan Implants Pipeline
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Highlights
2016: value Inflection year.File IND to conduct clinical trials.
1 2 3
Addressing life-threatening conditions of the esophagus,
bronchus and trachea.
Proprietary Cellframe technology generating
first-in-classCellspan implants.
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NASDAQ:BSTG
A New Beginning
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©2016 Biostage, Inc.. All rights reserved. B003.03.16 Rev 1