8-K
Harvard Apparatus Regenerative Technology, Inc. (HRGN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2020
BIOSTAGE, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35853 | 45-5210462 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 84 October Hill Road, Suite 11, Holliston, MA | 01746 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (774) 233-7300
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act: None
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
| Item 2.02. | Results of Operations and Financial Condition. |
|---|
On November 13, 2020, Biostage, Inc., or the Company, issued a press release announcing financial results for the three and nine months ended September 30, 2020. The press release is furnished as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits. |
| --- | --- |
| Exhibit<br><br> <br>Number | Title |
| --- | --- |
| 99.1 | Press Release issued by Biostage, Inc. on November 13, 2020 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BIOSTAGE, INC. | |
|---|---|
| (Registrant) | |
| November 13, 2020 | /s/ Hong Yu |
| (Date) | Hong Yu |
| President |
EXHIBIT 99.1
BiostageReports Third Quarter 2020 Financial Results
Holliston, MA – November 13, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing bioengineered organ implants based on the Company’s novel Cellspan™ technology for the treatment of esophageal atresia and esophageal disease, today announced its financial results for the three and nine months ended September 30, 2020.
The Company will not hold an earnings conference call at this time. The Company plans to hold a conference call at a future date to discuss its clinical and business plans.
Operating Highlights
Following the approval of Biostage’s Investigational New Drug Application from U.S. Food and Drug Administration (FDA) in March of this year, Biostage continued its efforts during the third quarter for clinical planning, including engaging with clinical research organizations as well as other contract research organizations in advance of the start of the clinical trial for the Company’s CEI product candidate.
Although the Company continues to make progress towards the start of its first clinical trial, the COVID-19 pandemic has and will continue to affect the Company’s operations, including causing delays or difficulties in its ability to finalize plans for the clinical study.
Summaryof Financial Results
For the three months ended September 30, 2020, the Company reported a net loss of $0.7 million, ($0.07) per share, compared to a net loss of $2.4 million, ($0.33) per share, for the three months ended September 30, 2019. The $1.7 million year-over-year net loss decrease was due primarily to a $1.1 million decrease in research and development costs, a $0.4 million decrease in general and administrative expenses, and a $0.2 million increase in grant income from the Company’s Fast-Track Small Business Innovation Research (SBIR) grant.
For the nine months ended September 30, 2020, the Company reported a net loss of $3.8 million, ($0.45) per share, compared to a net loss of $6.7 million, ($1.02) per share, for the nine months ended September 30, 2019. The $2.9 million year-over-year net loss decrease was due primarily to $2.3 million of lower research and development costs, and a $0.7 million decrease in general and administrative expenses. Slightly offsetting the lower operating expense was a decrease of $0.1 million of grant income recorded from the Company’s SBIR grant.
Balance Sheet and Cash
At September 30, 2020, the Company had operating cash on-hand of $2.0 million. The Company also had debt of $0.4 million based on receiving a loan in May 2020 pursuant to the Paycheck Protection Program (PPP), established as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act, although there is no assurance that any portion of the loan will be forgiven.
During the nine-month period ended September 30, 2020, the Company used net cash in operations of $3.0 million and received $4.2 million from financing activities, including approximately $1.1 million of proceeds from private placement transactions that resulted in the issuance of 276,027 shares of the Company’s common stock and warrants to investors in private placement transactions and approximately $2.7 million from the issuance of 930,877 shares of its common stock to a group of investors in connection with the exercise of previously issued warrants. The Company also received proceeds of approximately $0.4 million from the aforementioned PPP loan.
About Biostage, Inc.
Biostage is a clinical-stage biotechnology company developing bioengineered organ implants based on the Company’s novel Cellspan™ technology. 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 tubular organ conditions. The Company’s novel technology harnesses the body’s response and modulates it toward the healing process to regenerate tissue and restore the continuity and integrity of the organ. 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.
Biostage, Inc. Social Media
The Company uses its website (www.biostage.com), corporate Twitter account (https://twitter.com/BiostageInc), and LinkedIn page (https://www.linkedin.com/company/biostage-inc) as channels of distribution of information about the Company and its product candidates. Such information may be deemed material information, and the Company may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Biostage’s website and its social media accounts in addition to following its press releases, SEC filings, public conference calls, and webcasts. The social media channels that Biostage intends to use as a means of disclosing the information described above may be updated from time to time.
Forward-LookingStatements
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 viability of the Company’s technology; success with respect to any clinical trials and other development and commercialization efforts of the Company’s products, which such success may not be achieved on a timely basis or at all; the Company’s financing activities; expectations as to 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 approvals may not be 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 impact of COVID-19 on the Company’s 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, 2019 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 and Operations
774-233-7300
shu@biostage.com
BIOSTAGE,INC.
CONSOLIDATEDBALANCE SHEETS
(In thousands,except par value and share data)
| December 31,<br> <br>2019 | |||||
|---|---|---|---|---|---|
| ASSETS | (Unaudited) | ||||
| Current assets: | |||||
| Cash | 2,048 | $ | 913 | ||
| Restricted cash | 50 | 50 | |||
| Grant receivable | 370 | - | |||
| Prepaid<br> expenses and other current assets | 174 | 444 | |||
| Total current assets | 2,642 | 1,407 | |||
| Property, plant and equipment,<br> net | 262 | 394 | |||
| Operating<br> lease assets | 115 | 191 | |||
| Total non-current assets | 377 | 585 | |||
| Total assets | 3,019 | $ | 1,992 | ||
| LIABILITIES AND STOCKHOLDERS’<br> EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable | 71 | $ | 241 | ||
| Accrued and other current liabilities | 393 | 438 | |||
| Current portion of notes payable | 224 | - | |||
| Warrant liability | 27 | 33 | |||
| Current<br> portion of operating lease liability | 78 | 102 | |||
| Total current liabilities | 793 | 814 | |||
| Notes payable, net of current<br> portion | 180 | - | |||
| Operating<br> lease liability, net of current portion | 37 | 89 | |||
| Total liabilities | 1,010 | $ | 903 | ||
| Commitments and contingencies | |||||
| Stockholders’ equity: | |||||
| Undesignated<br> preferred stock, 0.01 par value; 984,000 shares authorized and none issued and outstanding at September 30, 2020 and December<br> 31, 2019 | - | $ | - | ||
| Common stock, par value 0.01<br> per share, 60,000,000 shares authorized at September 30, 2020 and December 31, 2019; 9,388,407 and 8,155,555 issued and outstanding<br> at September 30, 2020 and December 31, 2019, respectively | 94 | 82 | |||
| Additional paid-in capital | 69,851 | 65,102 | |||
| Accumulated<br> deficit | (67,936 | ) | (64,095 | ) | |
| Total stockholders’ equity | 2,009 | 1,089 | |||
| Total liabilities and stockholders’<br> equity | 3,019 | $ | 1,992 |
All values are in US Dollars.
BIOSTAGE,INC.
CONSOLIDATEDSTATEMENTS OF OPERATIONS
(Unaudited)
(In thousands,except per share amounts)
| Three Months ended<br> <br>September 30, | Nine Months ended<br> <br>September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||
| Operating<br> expenses: | ||||||||||||
| Research<br> and development | 548 | 1,597 | 1,727 | 4,007 | ||||||||
| Selling,<br> general and administrative | 510 | 902 | 2,488 | 3,194 | ||||||||
| Total<br> operating expenses | 1,058 | 2,499 | 4,215 | 7,201 | ||||||||
| Operating<br> loss | (1,058 | ) | (2,499 | ) | (4,215 | ) | (7,201 | ) | ||||
| Other income (expense): | ||||||||||||
| Grant<br> income | 370 | 136 | 370 | 473 | ||||||||
| Change<br> in fair value of warrant liability | 28 | (14 | ) | 6 | (5 | ) | ||||||
| Interest<br> expense | - | - | (2 | ) | - | |||||||
| Total other income (expense),<br> net | 398 | 122 | 374 | 468 | ||||||||
| Net<br> loss | $ | (660 | ) | $ | (2,377 | ) | $ | (3,841 | ) | $ | (6,733 | ) |
| Basic<br> and diluted net loss per share | $ | (0.07 | ) | $ | (0.33 | ) | $ | (0.45 | ) | $ | (1.02 | ) |
| Weighted-average<br> common shares, basic and diluted | 8,855 | 7,224 | 8,594 | 6,611 |
BIOSTAGE,INC.
CONSOLIDATEDSTATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| Nine Months Ended<br> <br>September 30, | ||||||
|---|---|---|---|---|---|---|
| 2020 | 2019 | |||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
| Net loss | $ | (3,841 | ) | $ | (6,733 | ) |
| Adjustments to reconcile net loss to net cash used<br> in operating activities: | ||||||
| Share-based compensation expense | 1,004 | 1,353 | ||||
| Depreciation | 139 | 165 | ||||
| Change in fair value of warrant<br> liability | (6 | ) | 5 | |||
| Changes in operating assets<br> and liabilities: | ||||||
| Grant receivable | (370 | ) | 40 | |||
| Prepaid expenses and other<br> current assets | 270 | 375 | ||||
| Accounts payable | (170 | ) | 110 | |||
| Accrued<br> and other current liabilities | (45 | ) | 69 | |||
| Net cash used in operating activities | (3,019 | ) | (4,616 | ) | ||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||
| Purchases of property, plant<br> and equipment | (7 | ) | (118 | ) | ||
| Net cash used in investing activities | (7 | ) | (118 | ) | ||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
| Proceeds from issuance of common stock and warrants | 1,058 | 1,277 | ||||
| Proceeds from exercise of warrants | 2,741 | 3,250 | ||||
| Proceeds from notes payable | 404 | - | ||||
| Payments of tax withholdings<br> of shares repurchased for vested stock awards | (42 | ) | - | |||
| Net cash provided by financing<br> activities | 4,161 | 4,527 | ||||
| Net decrease in cash and restricted cash | 1,135 | (207 | ) | |||
| Cash and restricted cash at<br> beginning of period | 963 | 1,355 | ||||
| Cash and<br> restricted cash at end of period | $ | 2,098 | $ | 1,148 | ||
| Supplemental disclosure of non-cash investing<br> and financing activities: | ||||||
| Equipment<br> purchases included in accounts payable | $ | - | $ | - | ||
| Issuance of vested stock | $ | 42 | $ | - |