Bioengineered Organ Implant Developer HART Reviews Progress and Q4 2015 Results
Hosts Management Update Call Today at 5:00pm EDT
Hosts Management Update Call Today at 5:00pm EDT
HOLLISTON, Mass., March 17, 2016 /PRNewswire/ -- Harvard Apparatus Regenerative Technology, Inc. (NASDAQ: HART), announced its financial results for the fourth quarter and year ended December 31, 2015 and reviewed its corporate and research progress and plans.
HART is a biotechnology company developing bioengineered organ implants based on the Company's new Cellframe™ technology. HART's new Cellframe implant technology is comprised of a biocompatible scaffold that is seeded with the recipient's own stem cells. It is being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the hope of dramatically improving the treatment paradigm for these patients. HART continues to build on the positive animal data it released in November.
"HART has made significant progress over the past twelve months," said Jim McGorry, CEO of HART. "We have fundamentally reshaped our research and development and our entire company in improving and optimizing our new bioengineered organ implant technology. Our new Cellframe technology aims to optimize the interaction and signaling of the scaffold and the patient's own cells to improve regeneration and remodeling. Initial results from large-animal studies have been encouraging and in many ways suggest that our technology is an entirely new and innovative approach to restoring organ function."
"We are now advancing the development of our platform in collaborative large-animal studies with Mayo Clinic," continued Mr. McGorry. "We expect to provide an update on our progress in mid-second quarter 2016. During this past year, we have also enhanced our management team and our Board of Directors, and formed a Scientific Advisory Board to guide our progress. We have added experienced industry team members to execute on our new vision and I believe we are on a solid footing to the future."
HART is working to refine its new platform and to develop compelling data in support of its goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2016, seeking to initiate clinical trials. Based on its existing preclinical data, HART has selected life-threatening conditions of the esophagus as the initial clinical application for advancing its Cellframe technology through the IND process.
Key large-animal data for HART's Cellframe technology was first announced in November 2015, and HART currently anticipates providing an update on its ongoing large-animal research collaboration with Mayo Clinic mid-second quarter 2016.
Q4 2015 Highlights:
Early 2016 Highlights:
Q4 2015 Financial Highlights:
Fiscal Year 2015 Financial Highlights:
Conference Call Details:
Management: |
CEO Jim McGorry, CMO Saverio La Francesca, M.D. and CFO |
Tom McNaughton |
|
Date and Time: |
Thursday, March 17, 2016 at 5:00 p.m. (Eastern Time) |
Telephone access: |
877-407-8293 or 201-689-8349 (Int'l.) |
Live webcast/replay: |
|
Telephone replay: |
877-660-6853 or 201-612-7415 (Int'l.), access code 13632439 |
Available post-call through 11:59PM EDT, March 26, 2016 |
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 HART products, including its Cellframe ™ implant technology, by the FDA, EMA, MHRA 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 HART products, including its Cellframe implant 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 the our Cellframe implant technology, bioreactors, scaffolds and other devices and product candidates we pursue; 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, 2014 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. Harvard Apparatus Regenerative Technology 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.
About HART: (www.hartregen.com)
Harvard Apparatus Regenerative Technology (HART) is a biotechnology company developing bioengineered organ implants based on the Company's new Cellframe ™ technology. HART's new Cellframe implant technology is comprised of a biocompatible scaffold that is seeded with the recipient's own stem cells. It is being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the hope of dramatically improving the treatment paradigm for these patients
HART's new Cellframe technology continues to be developed and is currently being tested in a large-animal collaborative study with Mayo Clinic. HART is working to refine its new platform and to develop compelling data in support of its goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in late 2016 to initiate clinical trials. Based on its existing preclinical data, the company has selected life-threatening conditions of the esophagus as the initial clinical application for advancing its Cellframe technology.
Investor Relations Contact:
Tom McNaughton
Chief Financial Officer
774-233-7321
[email protected]
or
David Collins, Bill Jones, Helen Sun
Catalyst Global LLC
212-924-9800
[email protected]
Exhibit 1 |
||||||||||
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. |
||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||
(unaudited, in thousands, except per share data) |
||||||||||
Three Months ended |
Years ended |
|||||||||
2015 |
2014 |
2015 |
2014 |
|||||||
Revenues |
$ 8 |
$ 45 |
$ 118 |
$ 93 |
||||||
Cost of revenues |
84 |
23 |
139 |
48 |
||||||
Gross (loss) profit |
(76) |
22 |
(21) |
45 |
||||||
Operating expenses: |
||||||||||
Research and development |
1,166 |
1,286 |
4,786 |
5,119 |
||||||
Sales and marketing |
13 |
88 |
289 |
329 |
||||||
General and administrative |
1,035 |
1,490 |
6,605 |
5,654 |
||||||
Total operating expenses |
2,214 |
2,864 |
11,680 |
11,102 |
||||||
Operating loss |
(2,290) |
(2,842) |
(11,701) |
(11,057) |
||||||
Other income (expense), net |
- |
- |
(3) |
(4) |
||||||
Loss before income taxes |
(2,290) |
(2,842) |
(11,704) |
(11,061) |
||||||
Income taxes |
- |
- |
- |
- |
||||||
Net loss |
$ (2,290) |
$ (2,842) |
$ (11,704) |
$ (11,061) |
||||||
Basic and diluted net loss per share |
$ (0.17) |
$ (0.36) |
$ (1.05) |
$ (1.41) |
||||||
Weighted average common shares, basic and diluted |
13,409 |
7,851 |
11,154 |
7,821 |
||||||
Exhibit 2 |
|||||
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. |
|||||
CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION |
|||||
(unaudited, in thousands) |
|||||
December 31, |
December 31, |
||||
2015 |
2014 |
||||
ASSETS |
|||||
Cash |
$ 7,456 |
$ 5,272 |
|||
Other current assets |
513 |
556 |
|||
Property, plant and equipment, net |
1,074 |
1,376 |
|||
Total assets |
$ 9,043 |
$ 7,204 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Total liabilities |
$ 654 |
$ 710 |
|||
Total stockholders' equity |
8,389 |
6,494 |
|||
Total liabilities and stockholders' equity |
$ 9,043 |
$ 7,204 |
Exhibit 3 |
||||
HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. |
||||
CONSOLIDATED CONDENSED CASH FLOW INFORMATION |
||||
(unaudited, in thousands) |
||||
Years ended |
||||
2015 |
2014 |
|||
Cash flows used in operating activities: |
||||
Net loss: |
$ (11,704) |
$ (11,061) |
||
Non-cash items included in net loss |
4,444 |
2,928 |
||
Changes in assets and liabilities |
74 |
140 |
||
Net cash used in operating activities |
(7,186) |
(7,993) |
||
Cash flows used in investing activities: |
||||
Net cash used in investing activities |
(175) |
(1,164) |
||
Cash flows from financing activities: |
||||
Proceeds from issuance of common and convertible preferred stock, net |
9,554 |
420 |
||
Net cash provided by financing activities |
9,554 |
420 |
||
Effect of exchange rate changes on cash |
(9) |
1 |
||
Net increase (decrease) in cash |
2,184 |
(8,736) |
||
Cash at the beginning of the period |
5,272 |
14,008 |
||
Cash at the end of the period |
$ 7,456 |
$ 5,272 |
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SOURCE Harvard Apparatus Regenerative Technology, Inc.
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