Investor Presentation

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1 Investor Presentation 2016

2 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 Cellframe tm 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. 2

3 A New Beginning 3

4 Financial Snapshot NASDAQ capital market listed: BSTG ticker symbol Market cap approximately $23m as of $7.5m cash on-hand as of 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: $ m range per quarter last 4 quarters ended

5 Leadership Team Jim McGorry, MBA CEO Tom McNaughton, CPA CFO Saverio La Francesca, MD CMO Laura Mondano VP, 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: DeBakey Heart & 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 postapproval life-cycle management. Prior: Histogenics Corporation, Genzyme, Anika Therapeutics, Boston Scientific Regulatory Affairs Certified 5

6 Highlights Proprietary Cellframe technology generating first-in-class Cellspan implants. Addressing life-threatening conditions of the esophagus, bronchus and trachea. 2016: value Inflection year. Plan to file IND to conduct clinical trials. 6

7 2016 Highlights Positive preclinical data Progress on the ongoing preclinical study collaboration with Mayo IND submission to conduct clinical trials Q Q Q Q Q BIOSTAGE A new beginning Orphan drug submission and Pre-IND meeting with FDA 7

8 Cellframe Technology PROPRIETARY PERSONALIZED VERSATILE 8

9 Unmet Medical Needs Esophageal Cancer Non Small Cell Lung Cancer (NSCLC) Tracheal Cancer, Stenosis and Trauma 17,000 new cases a year and 15,000 US deaths One of the worst cancers. Limited alternatives. 40,000 new cases a year in US similar to colorectal and breast Complication rates as high as 50%. Sub-Optimal Existing Standards of Care ~8,000 patients in US & EU High complication rates requiring multiple interventions. 9

10 Cellspan Esophageal Implant Opportunity 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. 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. Cellspan Esophageal Implants 10

11 Cellspan Bronchial Implant Opportunity The Cellspan implant aims to repair the bronchus without sacrificing the lung, and without debilitating outcomes and complications. 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. Cellspan Bronchial Implants 11

12 Cellspan Tracheal Implant Opportunity The Cellspan implant aims to restore tracheal integrity and function with the hope of improved mortality and reduced long term complications. 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. Cellspan Tracheal Implants 12

13 Cellspan Implants may radically improve treatment options Esophageal Cancer Non Small Cell Lung Cancer (NSCLC) Tracheal Cancer, Stenosis and Trauma Stage I & II diagnosed ~15,000 Patients in US & EU Restore native esophagus function with the Cellspan Esophageal Implant Affecting bronchus ~5,000 Patients in US & EU Restore airway function, sparing a lung with the Cellspan Bronchial Implant ~8,000 patients in US & EU Reconstruct any portion of the trachea, to restore function with the Cellspan Tracheal Implant Total Revenue opportunity exceeds $1.5 Billion 13

14 Cellspan Implants Pipeline 14

15 Highlights Proprietary Cellframe technology generating first-in-class Cellspan implants. Addressing life-threatening conditions of the esophagus, bronchus and trachea. 2016: value Inflection year. File IND to conduct clinical trials. 15

16 A New Beginning NASDAQ: BSTG 16

17 2016 Biostage, Inc.. All rights reserved. B Rev 1