EXHIBIT 99.1

 

 

 

Biostage Reports 2019 Financial Results

 

·FDA Removes clinical hold on Cellspan™ Esophageal Implant (CEI) study

 

Holliston, MA – March 27, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a biotechnology company developing next-generation esophageal implants, today announced its financial results for the three and twelve months ended December 31, 2019.

 

Conference Call

 

Due to the impact of COVID-19, the Company will not hold a conference call at this time. The Company anticipates that it will hold a future conference call to discuss its clinical and business plans based on the U.S. Food and Drug Administration (FDA) removing the clinical hold on its Cellspan™ Esophageal Implant (CEI) study.

 

Operating Highlights

 

On October 30, 2019 Biostage announced the submission of its Investigational New Drug (IND) application to the FDA for the Company’s lead product candidate, the CEI, to treat patients with end-stage esophageal disease, absent of cancer, in adults that require a segmental surgical resection to repair the diseased tissue.

 

On March 24, 2020 the Company received a notification from the FDA which notified the Company that the clinical hold on its CEI study was removed and the Company may proceed with its study for its CEI. This FDA approval enables us to start our transition to a clinical-stage biotechnology company, and start clinical planning, including engaging with a clinical research organization and site readiness in advance of starting the clinical trial for our CEI product candidate.

 

Summary of Financial Results

 

For the three months ended December 31, 2019, the Company reported a net loss of $1.6 million, ($0.21 per share), compared to a net loss of $1.8 million, ($0.32 per share), for the three months ended December 31, 2018. The $0.2 million year-over-year decrease in net loss was due primarily to a $0.3 million decrease in research and development costs and a $0.1 decrease in general and administrative expenses, offset in part by a $0.2 million decrease in grant income for qualified expenditures from our SBIR grant.

 

For the year ended December 31, 2019, the Company reported a net loss of $8.3 million, ($1.21 per share), compared to a net loss of $7.5 million, ($1.69 per share), for the year ended December 31, 2018. The $0.8 million year-over-year increase in net loss was due primarily to a $0.9 million increase in research and development costs and a $0.1 million increase in general and administrative expenses, offset in part by a $0.1 million net decrease in expense from change in the fair value of warrants. In addition, the Company recognized grant income for qualified expenditures from the SBIR grant of $473,000 for the year ended December 31, 2019 compared to $401,000 for the year ended December 31, 2018.

 

 

 

 

Balance Sheet and Cash

 

At December 31, 2019, the Company had operating cash on-hand of $0.9 million and no debt. The Company used net cash in operations of $6.1 million during the year ended December 31, 2019.

 

During the year ended December 31, 2019, the Company received $5.8 million from financing activities, including approximately $1.8 million from the issuance of approximately 488,000 shares of common stock and warrants to investors in private placement transactions, and approximately $4.0 million from the issuance of 1,994,000 shares of its common stock to a group of investors in connection with the exercise of previously issued warrants.

 

Subsequent to the end of the year, the Company received approximately $0.6 million from the issuance of 151,027 shares of common stock and warrants to investors in private placement transactions. The Company also received approximately $0.4 million from the issuance of 214,000 shares of common stock to a group of investors in exchange for the exercise of previously issued warrants.

  

About Biostage, Inc.

 

Biostage is a bioengineering company that is developing next-generation esophageal implants. The Company’s Cellspan technology combines a proprietary, biocompatible scaffold with a patient’s own cells to create an esophageal implant that could potentially be used to treat pediatric esophageal atresia and other conditions that affect the esophagus. The Company’s esophageal implant leverages the body’s inherent capacity to heal itself as it is a “living tube” that facilitates regeneration of esophageal tissue and triggers a positive host response resulting in a tissue-engineered neo-conduit that restores continuity of the esophagus. These implants have the potential to dramatically improve the quality of life for children and adults. At Biostage, we believe the future of medicine has been inside us all along.

 

For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.

 

 

 

 

Forward-Looking Statements

 

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to our financing activities; development expectations and regulatory approval of any of the Company’s products, including those utilizing its Cellspan and Cellframe™ technology, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company’s products, including those utilizing its Cellspan and Cellframe technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain needed funds in the immediate future; the potential impact of COVID-19 on our business and operations; the Company’s ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading "Item 1A. Risk Factors" in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 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 forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

 

Investor Relations Contacts

 

Shunfu Hu

Vice President of Business Development

774-233-7300

shu@biostage.com

 

Peter Chakoutis

Vice President of Finance

774-233-7300

pchakoutis@biostage.com

 

 

 

 

BIOSTAGE, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share data)

 

  

December 31,

2019

  

December 31,

2018

 
ASSETS  (Unaudited)     
Current assets:          
Cash  $913   $1,305 
Restricted cash   50    50 
Grant receivable   -    176 
Prepaid expenses and other current assets   444    623 
Total current assets   1,407    2,154 
Property, plant and equipment, net   394    479 
Right-of-use assets   191    - 
Total non-current assets   585    479 
Total assets  $1,992   $2,633 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $241   $160 
Accrued and other current liabilities   438    404 
Warrant liability   33    98 
Current portion of operating lease liability   102    - 
Total current liabilities   814    662 
Operating lease liability, net of current portion   89    - 
Total liabilities  $903   $662 
           
Stockholders’ equity:          
Undesignated preferred stock, $0.01 par value; 984,000 shares authorized at December 31, 2019 and 2018, none issued and outstanding  $-   $- 
Common stock, par value $0.01 per share, 60,000,000 and 120,000,000 shares authorized at December 31, 2019 and 2018, respectively; 8,155,555 and 5,669,645 issued and outstanding at December 31, 2019 and 2018, respectively   82    57 
Additional paid-in capital   65,102    57,677 
Accumulated deficit   (64,095)   (55,763)
Total stockholders’ equity   1,089    1,971 
Total liabilities and stockholders’ equity  $1,992   $2,633 

 

 

 

 

BIOSTAGE, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share amounts)

 

  

Three Months ended

December 31,

  

Twelve Months ended

December 31,

 
   2019   2018   2019   2018 
Revenues  $-   $-   $-   $- 
                     
Operating expenses:                    
Research and development   845    1,148    4,852    3,916 
Selling, general and administrative   824    952    4,018    3,925 
Total operating expenses   1,669    2,100    8,870    7,841 
                     
Operating loss   (1,669)   (2,100)   (8,870)   (7,841)
                     
Other income (expense):                    
Grant income   -    176    473    401 
Change in fair value of warrant liability   70    89    65    (82)
Other expense   -    -    -    (7)
 Total other income (expense), net   70    265    538    312 
                     
Net loss  $(1,599)  $(1,835)  $(8,332)  $(7,529)
                     
Basic and diluted net loss per share  $(0.21)  $(0.32)  $(1.21)  $(1.69)
Weighted average common shares, basic and diluted   7,748    5,669    6,898    4,463 

 

 

 

 

BIOSTAGE, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

  

Twelve Months Ended

December 31,

 
   2019   2018 
CASH FLOWS FROM OPERATING ACTIVITIES          
Net loss  $(8,332)  $(7,529)
Adjustments to reconcile net loss to net cash used in operating activities:          
Share-based compensation expense   1,654    755 
Depreciation   214    261 
Amortization of right-of-use assets   97    - 
Change in fair value of warrant liability   (65)   82 
Loss on disposal of property, plant and equipment   -    7 
Changes in operating assets and liabilities:          
Grant receivable   176    (176)
Prepaid expenses and other current assets   179    (297)
Accounts payable   81    (763)
Accrued and other current liabilities   34    22 
Lease liabilities   (97)   - 
Net cash used in operating activities   (6,059)   (7,638)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchases of property, plant and equipment   (129)   (131)
Cash received from sale of property, plant and equipment   -    64 
Net cash used in investing activities   (129)   (67)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Repayment of related party advance   -    (300)
Proceeds from issuance of common stock and warrants, net of offering costs   1,807    5,322 
Proceeds from exercise of warrants   3,989    - 
Net cash provided by financing activities   5,796    5,022 
Net decrease in cash and restricted cash   (392)   (2,683)
Cash and restricted cash at the beginning of the year   1,355    4,038 
Cash and restricted cash at the end of the year  $963   $1,355 

 

 

View differences made from one to another to evaluate Biostage, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Biostage, Inc..

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Log in with your credentials

or    

Forgot your details?

Create Account