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): September
26, 2017
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
|
California |
1-12830 |
94-3127919 |
|
(State or other jurisdiction |
(Commission File Number) |
(IRS Employer Identification No.) |
1010 Atlantic Avenue
Suite 102
Alameda,
California 94501
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area code)
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))
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 ⃞
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. ⃞
Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in BioTime’s periodic reports filed with the SEC under the heading “Risk Factors” and other filings that BioTime may make with the Securities and Exchange Commission. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, BioTime disclaims any intent or obligation to update these forward-looking statements.
References in this Report to “BioTime,” “we” or “us” refer to BioTime, Inc.
This Report and the accompanying Exhibit 99.1 shall be deemed “furnished” and not “filed” under Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by BioTime under the Securities Act of 1933, as amended, or the Exchange Act except as may be expressly set forth by specific reference in such filing.
Section 7 - Regulation FD
Item 7.01 - Regulation FD Disclosure
On September 26, 2017, BioTime, Inc. issued the press release furnished as Exhibit 99.1, which, in its entirety, is incorporated herein by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01 - Financial Statements and Exhibits.
|
Exhibit Number |
Description |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
BIOTIME, INC. |
||||
|
Date: |
September 26, 2017 |
By: |
/s/Russell Skibsted |
|
|
|
Chief Financial Officer |
|||
Exhibit 99.1
BioTime Announces Positive Secondary and Additional Positive Long-Term Data from the Renevia® Pivotal Trial
ALAMEDA, Calif.--(BUSINESS WIRE)--September 26, 2017--BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, today announced that treated patients from the Renevia® pivotal trial in Europe retained an average of 70% of the transplanted volume at 12 months. Additionally, preliminary data for five patients indicates an average retention of 64% of the transplanted volume at 18 months. These data exceed management expectations for long-term performance of the Renevia® transplant. BioTime remains on track to file Renevia® for CE mark approval by the end of the year.
The Renevia® trial data will be further discussed at the BioTime presentation at the Ladenburg Thalmann 2017 Healthcare Conference in New York. The presentation is scheduled for 2:00 pm ET/11:00 am PT today, September 26, 2017. A live webcast and subsequent archived replay of the BioTime’s presentation may be accessed via the investor relations section of the BioTime’s website at www.investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-EventDetails&EventId=5263572.
“These additional positive data further support our confidence that Renevia® may soon become an important, stable long-term solution, not only for people with HIV-associated lipoatrophy, but for people with any facial fat loss, whether caused by pharmaceuticals, trauma or aging,” said BioTime’s Co-Chief Executive Officer, Adi Mohanty. “We are moving quickly to submit an application for a CE mark to the European regulatory agency, with a possible approval and commercial launch in 2018.”
BioTime previously reported meeting the primary endpoint of this pivotal trial and now has the remaining required data, secondary endpoints and safety report to complete the clinical data package necessary to file for a CE mark in Europe. The secondary endpoints, such as qualitative improvements, trended positive and support the statistically significant primary endpoint. Secondary data points were not powered for statistical significance, but positive trends were seen in both the Mid-Face Volume Deficit Scale and Body Image Quality of Life Inventory. BioTime remains on track for filing the CE mark application by the end of this year with possible approval and launch next year.
In this pivotal trial, BioTime studied patients with HIV-associated lipoatrophy, which is a severe form of lipoatrophy characterized by the pathological loss of body fat from under the skin. All Renevia® transplants were well tolerated and there were no device-related serious adverse events noted in this pivotal trial. The primary endpoint was the change in hemifacial volume at six months in the treated patients compared to patients in the delayed treatment arm as measured by 3-D photographic volumetric assessment. The 3-D volumetric endpoint directly measures retained volume over time.
The additional data were encouraging as further supporting the commercial prospects of Renevia®, and its potential for label expansion into other indications, such as cosmetic facial aesthetics. The facial aesthetics market is estimated to be over 5 billion dollars and growing at or near double digits.
Treated patients received approximately 5cc of Renevia® in each side of the face (hemifacial) and the following table details the average (mean) volume measured through 18 months.
| 6 Months | 9 Months | 12 Months | 18 Months | |||||||||
| Patients | 28 | 21 | 15 | 5 | ||||||||
| Mean volume measured (cc) | 5.1 | 4.1 | 3.5 | 3.2 | ||||||||
| Percent of retention | 100% | 82% | 70% | 64% | ||||||||
While only a small number of patients have been observed through 18 months, the results thus far are encouraging.
This positive data, along with the secondary endpoints and full safety report, will be presented at the upcoming International Federation for Adipose Therapeutics and Science (IFATS) conference. The IFATS conference will be held in Miami, FL. from November 30th through December 3rd of this year.
About Renevia®
Renevia® is an investigational medical device that is being developed as an alternative for whole adipose tissue transfer (fat grafting) procedures. Renevia’s® hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia® is part of the HyStem® hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells.
About BioTime, Inc.
BioTime is a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company’s current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell/drug delivery. Its clinical programs are based on two platform technologies: pluripotent cells, which can become any type of cell in the human body, and cell/drug delivery. Renevia®, a cell delivery product, met its primary endpoint in an EU pivotal trial for the treatment of facial lipoatrophy in HIV patients earlier this year. Submission for approval of Renevia® is expected later this year, with an anticipated commercial launch in 2018. OpRegen®, a retinal pigment epithelium transplant therapy, is in a Phase I/IIa multicenter trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and one private company, AgeX Therapeutics, Inc.
BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
To receive ongoing BioTime corporate communications, please click on the following link to join the Company’s email alert list: http://news.biotimeinc.com.
Forward-Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
CONTACT:
Investor Contact:
BioTime
David Nakasone, 510-871-4188
DNakasone@biotimeinc.com
or
Media
Contact:
JQA Partners, Inc.
Jules Abraham, 917-885-7378
jabraham@jqapartners.com