On November 9, 2017 BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology company developing and commercializing products addressing degenerative diseases, reported financial results for the third quarter ended September 30, 2017 (Press release, BioTime, NOV 9, 2017, View Source;p=RssLanding&cat=news&id=2316015 [SID1234521856]).
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"BioTime achieved several significant milestones during the third quarter, both in its clinical programs and in the execution of its corporate strategy," said Adi Mohanty, Co-Chief Executive Officer. "With the additional positive long-term data from our EU Renevia trial, and the expansion of the OpRegen trial into the U.S., physicians and patients that may benefit from these products are one step closer to approved therapies."
"BioTime successfully secured over $40 million in funding including a public equity offering, which will enable the advancement of our clinical programs into the middle of 2019," continued Mr. Mohanty.
Corporate Highlights
AgeX completed a $10 million financing, which is expected to fund its operations well into 2019.
BioTime Board of Directors approved a distribution of some or all of the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime’s shareholders. The Board also authorized management to work with investment banks and other financial institutions to finalize and implement the strategy for taking AgeX public, which may include a tax-free distribution.
BioTime successfully completed a public equity offering raising net proceeds of approximately $26.7 million. The raise was completed on attractive terms and included both new and existing investors.
BioTime was awarded two grants, one from the Israel Innovation Authority and one from the National Institutes of Health, totaling approximately $3.6 million.
Clinical Progress
Renevia
BioTime announced positive secondary and additional positive long-term data from the Renevia pivotal trial. Treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. The results thus far are encouraging and the long-term performance exceeded management expectations. All Renevia transplants were shown to be well tolerated and there were no device-related serious adverse events noted during this trial.
BioTime announced that an investigator-led clinical trial successfully treated its first patient in a study of Premvia, in combination with stromal vascular fraction cells, for the treatment of volume loss in the face, as was done in the Renevia pivotal trial. This clinical trial is studying Premvia in a cosmetic application. Premvia has 510(k) clearance in the U.S. for wound management. BioTime expects to file for CE Mark in Europe under the name Renevia for the treatment of facial lipoatrophy in HIV patients early next year.
OpRegen (dry-AMD)
Awarded a $2 million grant from the Israel Innovation Authority (IIA) for further development of OpRegen for Dry age-related macular degeneration. To date the IIA has provided grants totaling approximately $12 million.
Successful defense of two key patents providing protection to OpRegen. The patents were upheld during an opposition proceeding in March. In September, we announced the successful conclusion of the appeals. The two European patents (EP2554661 and EP2147094), cover the proprietary directed differentiation methods to produce pluripotent stem cell-derived cell replacement therapies being developed to treat retinal degenerative diseases, such as age-related macular degeneration.
Vision Restoration Program
Awarded a grant of up to $1.6 million from the Small Business Innovation Research program of the National Institutes of Health. The grant provides funding to further develop BioTime’s innovative, next generation vision restoration program for more advanced retinal diseases and injuries, which severely impact the quality of life for millions of people with no treatment option. This initiative aims at improving vision in people affected by blindness, whether caused by retinal injuries, age-related macular degeneration, retinitis pigmentosa or other causes.
AST-OPC1 (oligodendrocyte progenitor cells)
Asterias Biotherapeutics announced new 12-month data from the first efficacy cohort in the company’s ongoing Phase 1/2a SCiStar study designated to evaluate safety and efficacy of AST-OPC1 in spinal cord injury. The 12-month data showed 67% of Cohort 2 subjects have recovered 2 or more motor levels on at least one side through 12 months, which is more than double the rates of recovery seen in both matched historical controls and published data in a similar population. Also, the FDA granted the company’s request for AST-OPC1 to be designated a Regenerative Medicine Advanced Therapy under the 21st Century Cures Act.
AST-VAC2 (patient specific cancer vaccine)
Asterias Biotherapeutics announced that the Medicines and Healthcare Products Regulatory Agency and the NHS Research Ethics Committee have provided the necessary approvals to initiate the first-in-human clinical trial of AST-VAC2 in the United Kingdom. The trial, which is being sponsored and managed by Cancer Research UK, will examine the safety, tolerability, immunogenicity and activity of AST-VAC2 in non-small cell lung cancer patients and is expected to be initiated later this year.
Liquid Biopsy (lung cancer confirmatory blood test)
OncoCyte received Clinical Laboratory Improvements Amendments (CLIA) certification of registration from the Centers for Medicare and Medicaid Services. In addition, OncoCyte’s laboratory has passed inspection by the California Department of Public Health and is now fully licensed and operational. Clinical validation study initiated.
OncoCyte announced positive results from the Analytical Validation Study of its liquid biopsy lung cancer diagnostic test, DetermaVU.
Simplification and Unlocking Value
New Subsidiary AgeX Therapeutics, Inc.
BioTime Board of Directors approved a distribution of some or all of the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime’s shareholders. The Board also authorized management to work with investment banks and other financial institutions to finalize and implement the strategy for taking AgeX public, which may include a tax-free distribution.
Third Quarter Financial Results
Cash Position and Marketable Securities: Cash, cash equivalents and available for sale securities totaled $18.2 million as of September 30, 2017, compared to $15.8 million as of June 30, 2017. On October 17, 2017, we completed a public offering of our common stock in which we issued 11,057,693 shares of our common stock for aggregate net cash proceeds of $26.7 million, after deducting commissions, discounts and estimated offering expenses.
Value of Holdings in Public Affiliates: At September 30, 2017, BioTime held common stock in publicly-traded affiliates valued at $184.7 million. This amount was the market value of BioTime’s 21.7 million shares in Asterias Biotherapeutics (NYSE American: AST) and 14.7 million shares in OncoCyte (NYSE American: OCX).
Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties, and subscription and advertising from the marketing of online database products. Total revenue was $1.7 million for the third quarter of 2017, compared to $1.5 million in the third quarter of 2016.
Operating Expenses: Operating expenses for the third quarter of 2017 were $11.1 million. On an adjusted basis, operating expenses were $8.6 million, of which $6.5 million was mainly attributable to our clinical programs, while $2.1 million in expenses were related to AgeX.
Our operating expenses for the nine months ended September 30, 2017 were $33.4 million. Adjusted operating expenses were $26.8 million for this period, including $18.3 million spent on our clinical and early stage programs.
The reconciliation between GAAP and non-GAAP operating expenses by entity, is provided in the financial tables included with this earnings release.
R&D Expenses: Research and development expenses were $6.6 million for the third quarter of 2017, compared to $6.4 million for the comparable period in 2016, a decrease of $0.2 million.
G&A Expenses: General and administrative expenses were $4.6 million for the third quarter of 2017 compared to $4.6 million for the comparable period in 2016.
Net Income or loss attributable to BioTime: Net income attributable to BioTime was $14.3 million, or $0.12 per basic and diluted common share for the three months ended September 30, 2017, compared to net income of $31.2 million, or $0.30 per basic and diluted common share for the three months ended September 30, 2016. For the nine months ended September 30, 2017, net income attributable to BioTime was $52.0 million, or $0.47 per diluted common share, compared to $38.6 million, or $0.39 per share for the nine months ended September 30, 2016. Results in each period were primarily driven by noncash deconsolidation gains and noncash gains and losses in the changes in share prices of our public affiliate investments in Asterias and OncoCyte common stock.
Conference Call and Webcast Details
BioTime is hosting a conference call and webcast today, Thursday, November 9, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the results and recent corporate developments. The conference call dial-in number in the U.S./Canada is 1-877-407-0784. For international participants outside the U.S./Canada, the dial-in number is 1-201-689-8560. For all callers, please refer to the "BioTime, Inc. Conference Call." The live webcast can be accessed on the "Events & Presentations" page of the "Investors & Media" section on the company’s website at View Source;p=irol-calendar.
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./Canada: 1-844-512-2921; international callers dial 1-412-317-6671. Use the Conference ID 13671848. Additionally, the archived webcast will be available on the "Events & Presentations" page of the "Investors & Media" section on the company’s website at View Source;p=irol-calendar.
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 OpRegen
OpRegen, which is being studied for the treatment of the dry form of AMD, consists of a suspension of Retinal Pigment Epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen RPE cells. OpRegen RPE cells are also "xeno-free," meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen is designed to be an "off-the-shelf" allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen would be administered in a single procedure. OpRegen was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.
About Premvia
Approved Uses
Premvia is indicated for the management of wounds including: partial-thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh’s surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears, and draining wounds.
Contraindications
Premvia is contraindicated for patients with severe allergies, indicated by a history of anaphylaxis or presence of multiple severe allergies.
Premvia is specifically contraindicated for patients with known allergies to products containing either hyaluronan or collagen derivatives.
Premvia is not indicated for use in third degree burns.
Important Safety Information
Complications that may arise from wound management products may include: infection, chronic inflammation, allergic reaction, excessive redness, pain, or swelling. If any of these complications are present, product should be removed from the wound area.
Federal law restricts this device to sale by or on the order of a physician or practitioner.
Only the vial contents are sterile – outside of vials are not sterile.
Do not add additional components or additives to Premvia.