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4 4  
5 5  = Overview =
6 6  
7 -Biostage (BSTG) is a biotechnology company developing bioengineered organ implants based on its novel CellframeTM technology. The company's Cellframe technology is comprised of a biocompatible scaffold that is seeded with the recipient’s own stem cells. This technology is being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the objective of dramatically improving the treatment paradigm for those patients.
7 +Biostage is a biotechnology company developing bioengineered organ implants based on its novel CellframeTM technology. The company's Cellframe technology is comprised of a biocompatible scaffold that is seeded with the recipient’s own stem cells. This technology is being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the objective of dramatically improving the treatment paradigm for those patients.
8 8  
9 9  The company believe that its Cellframe technology will provide surgeons with new ways to address damage to the esophagus, bronchus, and trachea due to congenital abnormalities, cancer, infection or trauma. Products being developed based on its Cellframe technology for those indications are called CellspanTM products.
10 10  
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20 20  
21 21  Following the failure to receive the funding with respect to a securities purchase agreement in August 2017, and in an effort to conserve cash, the company completed a reduction in headcount of 20 persons during October and November 2017. In addition, its officers agreed to a temporary reduction in their cash salaries by 50% effective November 2017. During Q1 2018, the salaries of its officers were increased to approximately 80% of their contracted rate. Biostage has accrued the difference between the officers contracted rate and amount paid for November 2017 through March 2018. Following the capital raises in December 2017 and January 2018 described below the company re-hired five of its former employees into key positions in January 2018. The company believe that its new staffing level after those hires is sufficient to pursue both of its esophageal programs and the company anticipate its 2018 cash burn needs to be significantly less than its 2017 burn.
22 22  
23 -= Restoring Organ Function =
23 +==== Restoring Organ Function ====
24 24  
25 25  Following extensive research and development, Biostage has evolved its technology to optimize the interaction of mesenchymal stem cells seeded on a biocompatible scaffold. Preclinical studies suggest that, once implanted, the scaffold seeded with the patient’s own cells signals the stem cell niche to guide the regeneration of a biological structure.
26 26  
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36 36  
37 37  Biostage is investigating its Cellframe technology to replace diseased sections of the esophagus, trachea and bronchus, possible life-threatening conditions that are underserved by current therapies
38 38  
39 -= December 2017 Private Placements and Reverse Stock Split =
39 +==== December 2017 Private Placements and Reverse Stock Split ====
40 40  
41 41  Between December 27 and December 29, 2017, the company entered into Securities Purchase Agreements with new investors for the sale of its capital stock. Theses agreement and related transactions resulted in the following:
42 42  
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48 48  
49 49  Additionally, on February 20, 2018, the company completed a private placement of 302,115 shares of common stock at a purchase price of $3.31 per share for net proceeds of $1.0 million.
50 50  
51 -= Small Business Innovation Research Grant =
51 +==== Small Business Innovation Research Grant ====
52 52  
53 53  On March 28, 2018, the company were awarded a Fast-Track Small Business Innovation Research (SBIR) grant by the Eunice Kennedy National Institute of Child Health and Human Development. The award for Phase I, which is expected to be earned through the third quarter of 2018, provides for the reimbursement of up to $225,000 of qualified research and development costs or expenditures. The SBIR grant has the potential to provide a total award of $1.7 million. If Phase I is successful, and funding is available, a Phase II award of up to approximately $1.5 million would support pre-clinical testing of pediatric Cellspan Esophageal Implants planned to begin later in 2018. The Phase II funds, if awarded, would be spent over an estimated two years.
54 54  
55 -= Operating Losses and Cash Requirements =
55 +==== Operating Losses and Cash Requirements ====
56 56  
57 57  Biostage has incurred substantial operating losses since its inception, and as of March 31, 2018 had an accumulated deficit of approximately $49.8 million, which will require it to seek additional financing to fund future operations. The company expect that its cash on hand at March 31, 2018 of $2.8 million will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2018.
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60 60  
61 61  On May 1, 2018, the company entered into Securities Purchase Agreements (the “Purchase Agreements”) with Chu Bogang and Zhou Heping (each an “Investor” and together “Investors”) pursuant to which the Investors agreed to purchase in private placements (the “Private Placements”), and the company agreed to issue, 500,000 shares of its common stock, par value $0.01 per share (the “Common Stock”) at a purchase price of $3.60 per share to each of the Investors for a total combined issuance of 1,000,000 shares of its Common Stock. The Private Placements are expected to close later in May.
62 62  
63 -= Financial Condition, Liquidity and Capital Resources =
63 +==== Financial Condition, Liquidity and Capital Resources ====
64 64  
65 65  Sources of liquidity. Biostage has incurred operating losses since inception, and as of March 31, 2018 the company had an accumulated deficit of approximately $49.8 million. Biostage is currently investing significant resources in the development and commercialization of its products for use by clinicians and researchers in the field of regenerative medicine. As a result, the company expect to incur operating losses and negative operating cash flow for the foreseeable future.
66 66  
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