HOLLISTON, Mass., Nov. 12, 2019 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG), a bioengineering company developing next-generation esophageal implants, today announced its financial results for the three and nine months ended September 30, 2019.
View full release with investor resources, link to webcast, downloadable financial tables, images and more.
Key Takeaways
- Submitted Investigational New Drug (IND) application in October for lead product candidate Cellspan™ Esophageal Implant for treatment of esophageal conditions.
- Received approximately $1.2 million from the exercise of warrants, extending the Company's finances and demonstrating investor confidence in the Company's technology.
- Biostage, subject to FDA approval, will begin clinical trials.
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 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 Contact
Peter Chakoutis
Vice President of Finance
774-233-7300
Biostage, Inc.
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share data)
|
September 30, |
December 31, |
|||||
|
2019 |
2018 |
|||||
|
Assets |
(Unaudited) | |||||
| Current assets: | ||||||
|
Cash |
$ |
1,098 |
$ |
1,305 |
||
|
Restricted cash |
50 |
50 |
||||
|
Grant receivable |
136 |
176 |
||||
|
Prepaid expenses and other current assets |
248 |
623 |
||||
|
Total current assets |
1,532 |
2,154 |
||||
|
Property, plant and equipment, net |
432 |
479 |
||||
|
Right-of-use assets |
95 |
- |
||||
|
Total non-current assets |
|
527 |
|
479 |
||
|
Total assets |
$ |
2,059 |
$ |
2,633 |
||
|
Liabilities and stockholders' equity |
||||||
| Current liabilities | ||||||
|
Accounts payable |
$ |
270 |
$ |
160 |
||
|
Accrued and other current liabilities |
473 |
404 |
||||
|
Warrant liability |
|
103 |
|
98 |
||
|
Current portion of operating lease liability |
72 |
- |
||||
|
Total current liabilities |
|
918 |
|
662 |
||
|
Operating lease liability, net of current portion |
|
23 |
|
- |
||
| Total liabilities |
$ |
941 |
$ |
662 |
||
| Commitments and contingencies | ||||||
| Stockholders' equity: | ||||||
|
Undesignated preferred stock, $0.01 par value; 984,000 shares authorized and none issued and outstanding at September 30, 2019 and December 31, 2018 |
$ |
- |
$ |
- |
||
|
Common stock, $0.01 par value; 120,000,000 shares authorized at September 30, 2019 and December 31, 2018; 7,643,325 and 5,669,645 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively |
76 |
57 |
||||
|
Additional paid-in capital |
63,538 |
57,677 |
||||
|
Accumulated deficit |
(62,496) |
(55,763) |
||||
| Total stockholders' equity |
|
1,118 |
|
1,971 |
||
| Total liabilities and stockholders' equity |
$ |
2,059 |
$ |
2,633 |
||
|
Three Months Ended |
Nine Months ended |
|||||||||||
|
2019 |
2018 |
2019 |
2018 |
|||||||||
|
Revenues |
$ |
- |
$ |
- |
$ |
- |
$ |
- |
||||
|
Operating expenses |
||||||||||||
|
Research and development |
|
1,597 |
$ |
1,288 |
|
4,007 |
|
2,768 |
||||
|
Selling, general and administrative |
902 |
940 |
3,194 |
2,973 |
||||||||
|
Total operating expenses |
2,499 |
2,228 |
7,201 |
5,741 |
||||||||
|
Operating loss |
(2,499) |
(2,228) |
(7,201) |
(5,741) |
||||||||
|
Other income (expense) |
||||||||||||
|
Grant income |
136 |
90 |
473 |
225 |
||||||||
|
Change in fair value of warrant liability |
(14) |
49 |
(5) |
(171) |
||||||||
|
Other expense |
- |
- |
- |
(7) |
||||||||
|
Total other income (expense), net |
122 |
139 |
468 |
47 |
||||||||
|
Net loss |
$ |
(2,377) |
$ |
(2,089) |
$ |
(6,733) |
$ |
(5,694) |
||||
|
Basic and diluted net loss per share |
$ |
(0.33) |
$ |
(0.37) |
$ |
(1.02) |
$ |
(1.40) |
||||
|
Weighted-average common shares, basic and diluted |
|
7,224 |
|
5,666 |
|
6,611 |
|
4,056 |
||||
|
Nine Months Ended September 30, |
||||||
|
2019 |
2018 |
|||||
|
CASH FLOWS FROM OPERATING ACTIVITIES |
||||||
|
Net loss |
$ |
(6,733) |
$ |
(5,694) |
||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
|
Share-based compensation expense |
1,353 |
461 |
||||
|
Depreciation |
165 |
194 |
||||
|
Amortization of right-of-use assets |
71 |
- |
||||
|
Change in fair value of warrant liability |
5 |
171 |
||||
|
Loss on disposal of property, plant and equipment |
- |
8 |
||||
| Changes in operating assets and liabilities: | ||||||
|
Grant receivable |
40 |
(90) |
||||
|
Prepaid expenses and other current assets |
375 |
53 |
||||
|
Accounts payable |
110 |
(721) |
||||
|
Accrued and other current liabilities |
69 |
164 |
||||
|
Lease liabilities |
(71) |
- |
||||
|
Net cash used in operating activities |
(4,616) |
(5,454) |
||||
|
CASH FLOWS FROM INVESTING ACTIVITIES |
||||||
|
Purchases of property and equipment |
(118) |
(127) |
||||
|
Cash received from sale of property, plant and equipment |
- |
64 |
||||
|
Net cash used in investing activities |
(118) |
(63) |
||||
|
CASH FLOWS FROM FINANCING ACTIVITIES |
||||||
|
Repayment of related party advance |
- |
(300) |
||||
|
Proceeds from issuance of common stock and warrants, net of offering costs |
1,277 |
5,322 |
||||
|
Proceeds from exercise of warrants |
3,250 |
- |
||||
|
Net cash provided by financing activities |
4,527 |
5,022 |
||||
|
Net decrease in cash and restricted cash |
(207) |
(795) |
||||
|
Cash and restricted cash at beginning of period |
1,355 |
4,038 |
||||
|
Cash and restricted cash at end of period |
$ |
1,148 |
$ |
3,543 |
||
SOURCE Biostage, Inc.