HOLLISTON, Mass., March 2, 2017 /PRNewswire/ -- Biostage, Inc. (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, announced today that it will report its financial results for the year ended December 31, 2016 in a press release that will be issued pre-market on Thursday, March 9, 2017. Biostage Management also announced that it will host a conference call with live audio webcast that same day at 9:00 a.m. ET to review its operational progre
ss, expected near-term milestones and financial report.
The conference call and live webcast will be accompanied by a slide presentation. To participate in the call, please dial (877) 407-8293 (domestic) or (201) 689-8349 (international). The live webcast and accompanying slides will be accessible on the Events page of the Investors section on the Company's website at www.biostage.com and will be archived for 60 days. An audio webcast will be available for one week following the call can be accessed by dialing (877) 660-6853 (domestic) or (201) 612-7415 (international) with Conference ID #: 13656760.
About Biostage
Biostage is a biotechnology company developing bioengineered organ implants based on the Company's new Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create Cellspan™ organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.
Cellspan implants are currently being advanced and tested in collaborative preclinical studies. Preclinical, large-animal safety studies, conducted in compliance with the FDA Good Laboratory Practice (GLP) regulations, for the Company's Cellspan Esophageal Implant product candidate are ongoing, in support of Biostage's goal of filing an Investigational New Drug (IND) application with the U.S. FDA in the third quarter of 2017. The IND will seek approval to initiate clinical trials for its esophageal implant product candidate in humans.
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 the development expectations and regulatory approval of any of our products, including those utilizing our 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 our products, including those utilizing our 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, our ability to obtain and maintain regulatory approval for our products; plus other factors described under the heading "Item 1A. Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage 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:
Tom McNaughton
Chief Financial Officer
774-233-7321
Jenene Thomas
Jenene Thomas Communications LLC
(908) 938-1475
Media Contacts:
David Schull or Maggie Beller
Russo Partners LLC
212-845-4271 or 646-942-5631
Email:
Biostage, Inc.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|
December 31, |
December 31, |
|||||
|
2016 |
2015 |
|||||
|
Assets |
||||||
| Current assets: | ||||||
|
Cash |
$ |
2,941 |
$ |
7,456 |
||
|
Accounts receivable |
42 |
21 |
||||
|
Inventory |
- |
75 |
||||
|
Prepaid expenses |
291 |
330 |
||||
|
Other current assets |
212 |
- |
||||
|
Total current assets |
3,486 |
7,882 |
||||
|
Property, plant and equipment, net |
1,065 |
1,074 |
||||
|
Total non-current assets |
|
1,065 |
|
1,074 |
||
|
Total assets |
$ |
4,551 |
$ |
8,956 |
||
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||
| Current liabilities | ||||||
|
Accounts payable |
$ |
962 |
$ |
357 |
||
|
Accrued and other current liabilities |
1,210 |
297 |
||||
|
Warrant liability |
605 |
- |
||||
|
Total current liabilities |
|
2,777 |
|
654 |
||
| Total liabilities |
$ |
2,777 |
$ |
654 |
||
| Stockholders' equity: | ||||||
|
Undesignated preferred stock, $0.01 par value; 1,000,000 and 1,000,000 shares |
$ |
- |
$ |
- |
||
|
Series B convertible preferred stock, par value $0.01 per share, 1,000,000 shares authorized; 695,857 shares issued and none outstanding |
$ |
- |
$ |
- |
||
|
Common stock, par value $0.01 per share, 60,000,000 and 30,000,000 shares |
171 |
141 |
||||
|
Additional paid-in capital |
37,921 |
32,908 |
||||
|
Accumulated deficit |
(36,318) |
(24,739) |
||||
|
Accumulated other comprehensive loss |
- |
(8) |
||||
| Total stockholders' equity |
|
1,774 |
|
8,302 |
||
| Total liabilities and stockholders' equity |
$ |
4,551 |
$ |
8,956 |
||
|
Three Months Ended |
Twelve Months ended |
|||||||||||
|
2016 |
2015 |
2016 |
2015 |
|||||||||
|
Revenues |
$ |
28 |
$ |
8 |
$ |
82 |
$ |
118 |
||||
|
Cost of revenues |
|
59 |
|
84 |
|
116 |
|
139 |
||||
|
Gross loss |
|
(31) |
|
(76) |
|
(34) |
|
(21) |
||||
|
Operating expenses |
||||||||||||
|
Research and development |
|
2,324 |
$ |
1,166 |
|
7,603 |
|
4,786 |
||||
|
Selling, general and administrative |
1,228 |
1,048 |
4,489 |
6,894 |
||||||||
|
Total operating expenses |
3,552 |
2,214 |
12,092 |
11,680 |
||||||||
|
Operating loss |
(3,583) |
(2,290) |
(12,126) |
(11,701) |
||||||||
|
Other income (expense) |
||||||||||||
|
Change in fair value of warrant liability, net of issuance cost of $129 |
241 |
- |
547 |
- |
||||||||
|
Other expense |
- |
- |
- |
(3) |
||||||||
|
Other Income (Expense) |
241 |
- |
547 |
(3) |
||||||||
|
Loss before income taxes |
(3,342) |
(2,290) |
(11,579) |
(11,704) |
||||||||
|
Income taxes |
- |
- |
- |
- |
||||||||
|
Net loss |
$ |
(3,342) |
$ |
(2,290) |
$ |
(11,579) |
$ |
(11,704) |
||||
|
Basic and diluted net loss per share |
$ |
(0.20) |
$ |
(0.17) |
$ |
(0.73) |
$ |
(1.05) |
||||
|
Weighted-average common shares, basic and diluted |
|
17,109 |
|
13,409 |
|
15,971 |
|
11,157 |
||||
|
Years ended December 31, |
||||||
|
2017 |
2016 |
|||||
|
Cash flows used in operating activities: |
||||||
|
Net loss |
$ |
(11,579) |
$ |
(11,704) |
||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
|
Stock-based compensation expense |
1,327 |
3,966 |
||||
|
Depreciation |
454 |
478 |
||||
|
Change in fair value of warrant liability, net of issuance cost of $129 |
(547) |
- |
||||
| Changes in operating assets and liabilities: | ||||||
|
Related party receivables, net |
- |
11 |
||||
|
Accounts receivable |
(21) |
(16) |
||||
|
Inventories |
75 |
132 |
||||
|
Prepaid expenses |
39 |
(13) |
||||
|
Other current assets |
(212) |
- |
||||
|
Accounts payable |
472 |
(13) |
||||
|
Accrued and other current liabilities |
934 |
(27) |
||||
|
Net cash used in operating activities |
(9,058) |
(7,186) |
||||
|
Cash flows used in investing activities: |
||||||
|
Additions to property, plant and equipment |
(302) |
(176) |
||||
|
Net cash used in investing activities |
(302) |
(176) |
||||
|
CASH FLOWS FROM FINANCING ACTIVITIES |
||||||
|
Proceeds from issuance of common stock and warrants, net of offering costs |
4,496 |
- |
||||
|
Proceeds from issuance of common stock, net of offering costs |
349 |
4,198 |
||||
|
Proceeds from issuance of Series B convertible preferred stock, net of offering costs |
- |
5,357 |
||||
|
Net cash provided by financing activities |
4,845 |
9,555 |
||||
|
Effect of exchange rate changes on cash |
- |
(9) |
||||
|
Net (decrease) increase in cash |
(4,515) |
2,184 |
||||
|
Cash at the beginning of the year |
7,456 |
5,272 |
||||
|
Cash at the end of the year |
$ |
2,941 |
$ |
7,456 |
||
SOURCE Biostage, Inc.