Press Releases
BioTime Reports Third Quarter Results and Recent Corporate Accomplishments
- Over
$40M in recent funding - Renevia advancing toward anticipated regulatory approval in
Europe - OpRegen advancing in clinical trials
- AgeX distribution expected to be completed by early second quarter 2018
“BioTime achieved several significant milestones during the third quarter, both in its clinical programs and in the execution of its corporate strategy,” said
“BioTime successfully secured over
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 theIsrael Innovation Authority and one from theNational 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 inEurope 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 theIsrael 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, theFDA 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 theCenters for Medicare and Medicaid Services . In addition, OncoCyte’s laboratory has passed inspection by theCalifornia 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
- 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
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
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
Our operating expenses for the nine months ended
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
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./
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./
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™.
About
BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on Twitter, LinkedIn,
To receive ongoing
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 product technology, clinical development, regulatory approval timelines, the success of potential cosmetic applications and potential opportunities for
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BIOTIME, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
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| September 30, | ||||||||
| 2017 | December 31, | |||||||
| (Unaudited) | 2016 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 16,662 | $ | 22,088 | ||||
| Available for sale securities | 1,511 | 627 | ||||||
| Grants and other accounts receivable | 1,420 | 646 | ||||||
| Receivable from affiliates, net | 2,278 | 511 | ||||||
| Prepaid expenses and other current assets | 1,354 | 1,777 | ||||||
| Total current assets | 23,225 | 25,649 | ||||||
| Property, plant and equipment, net | 5,423 | 5,529 | ||||||
|
Deposits and other long-term assets |
1,005 | 1,149 | ||||||
| Equity method investment in OncoCyte, at fair value | 110,790 | - | ||||||
| Equity method investment in Asterias, at fair value | 73,942 | 100,039 | ||||||
| Intangible assets, net | 7,482 | 10,206 | ||||||
| TOTAL ASSETS | $ | 221,867 | $ | 142,572 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 5,360 | $ | 7,144 | ||||
| Capital lease liability, current portion | - | 202 | ||||||
| Promissory notes, current portion | 126 | 99 | ||||||
| Related party convertible debt, net of discount | 13 | 833 | ||||||
| Deferred revenues, current portion | 513 | 572 | ||||||
| Total current liabilities | 6,012 | 8,850 | ||||||
|
LONG-TERM LIABILITIES |
||||||||
| Deferred revenues, net of current portion | 77 | 308 | ||||||
| Deferred rent liabilities, net of current portion | 91 | 50 | ||||||
| Lease liability | 1,257 | 1,386 | ||||||
| Capital lease liability, net of current and other liabilities | - | 310 | ||||||
| Related party convertible debt, net of discount | - | 1,032 | ||||||
| Promissory notes, net of current portion | 44 | 120 | ||||||
| Deferred tax liability | 4,845 | - | ||||||
|
Other long-term liabilities |
554 | 8 | ||||||
| TOTAL LIABILITIES | 12,880 | 12,064 | ||||||
| Commitments and contingencies | ||||||||
| SHAREHOLDERS’ EQUITY | ||||||||
| Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of September 30, 2017 and December 31, 2016 | - | - | ||||||
| Common shares, no par value, 150,000 shares authorized; 115,804 shares issued and outstanding as of September 30, 2017, and 103,396 shares issued and 102,776 shares outstanding as of December 31, 2016 | 342,508 | 317,878 | ||||||
| Accumulated other comprehensive income (loss) | 141 | (738 | ) | |||||
| Accumulated deficit | (144,363 | ) | (196,321 | ) | ||||
| Treasury stock at cost: no shares as of September 30, 2017; 620 shares as of December 31, 2016 | - | (2,891 | ) | |||||
| BioTime, Inc. shareholders’ equity | 198,286 | 117,928 | ||||||
|
Noncontrolling interest |
10,701 | 12,580 | ||||||
| Total shareholders’ equity | 208,987 | 130,508 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 221,867 | $ | 142,572 | ||||
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BIOTIME, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) |
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Three Months Ended |
Nine Months Ended |
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| REVENUES: | ||||||||||||||||
| Grant income | $ | 1,225 | $ | 1,109 | $ | 1,236 | $ | 3,346 | ||||||||
| Royalties from product sales and license fees | 86 | 177 | 277 | 463 | ||||||||||||
| Subscription and advertisement revenues | 376 | 69 | 940 | 700 | ||||||||||||
| Sale of research products | 1 | 144 | 6 | 331 | ||||||||||||
| Total revenues | 1,688 | 1,499 | 2,459 | 4,840 | ||||||||||||
| Cost of sales | (52 | ) | (58 | ) | (114 | ) | (378 | ) | ||||||||
| Gross Profit | 1,636 | 1,441 | 2,345 | 4,462 | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | (6,562 | ) | (6,422 | ) | (19,327 | ) | (29,093 | ) | ||||||||
| General and administrative | (4,587 | ) | (4,574 | ) | (14,111 | ) | (23,083 | ) | ||||||||
| Total operating expenses | (11,149 | ) | (10,996 | ) | (33,438 | ) | (52,176 | ) | ||||||||
| Gain on sale of assets | - | - | 1,754 | - | ||||||||||||
| Loss from operations | (9,513 | ) | (9,555 | ) | (29,339 | ) | (47,714 | ) | ||||||||
| OTHER INCOME/(EXPENSES): | ||||||||||||||||
| Interest expense, net | (10 | ) | (167 | ) | (729 | ) | (513 | ) | ||||||||
| Gain on equity method investment in OncoCyte at fair value | 34,485 | - | 39,620 | - | ||||||||||||
| Gain (loss) on equity method investment in Asterias at fair value | (3,262 | ) | 40,015 | (26,097 | ) | 26,532 | ||||||||||
| Gain on deconsolidation of OncoCyte | - | - | 71,697 | - | ||||||||||||
| Gain on deconsolidation of Asterias | - | - | - | 49,048 | ||||||||||||
| Loss on extinguishment of related party convertible debt | (2,799 | ) | - | (2,799 | ) | - | ||||||||||
| BioTime's share of losses in equity method investment in Ascendance Biotechnology, Inc. | - | (855 | ) | - | (1,189 | ) | ||||||||||
| Other income (expenses), net | (143 | ) | (173 | ) | 1,202 | 197 | ||||||||||
| Total other income, net | 28,271 | 38,820 | 82,894 | 74,075 | ||||||||||||
| INCOME BEFORE INCOME TAXES | 18,758 | 29,265 | 53,555 | 26,361 | ||||||||||||
| Deferred income tax expense | (4,772 | ) | - | (4,772 | ) | - | ||||||||||
| NET INCOME | 13,986 | 29,265 | 48,783 | 26,361 | ||||||||||||
| Net loss attributable to noncontrolling interests | 335 | 1,934 | 3,175 | 12,286 | ||||||||||||
| NET INCOME ATTRIBUTABLE TO BIOTIME, INC. | $ | 14,321 | $ | 31,199 | $ | 51,958 | $ | 38,647 | ||||||||
| NET INCOME PER COMMON SHARE ATTRIBUTABLE TO BIOTIME, INC.: | ||||||||||||||||
| BASIC | $ | 0.12 | $ | 0.30 | $ | 0.47 | $ | 0.40 | ||||||||
| DILUTED | $ | 0.12 | $ | 0.30 | $ | 0.47 | $ | 0.39 | ||||||||
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING: | ||||||||||||||||
| BASIC | 115,288 | 102,711 | 110,989 | 95,484 | ||||||||||||
| DILUTED | 115,298 | 103,613 | 111,124 | 99,073 | ||||||||||||
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BIOTIME, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) (UNAUDITED) |
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| Nine Months Ended | |||||||||
| September 30, | |||||||||
| 2017 | 2016 | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||||
| Net income attributable to BioTime, Inc. | $ | 51,958 | $ | 38,647 | |||||
| Net loss allocable to noncontrolling interests | (3,175 | ) | (12,286 | ) | |||||
| Adjustments to reconcile net income attributable to BioTime, Inc. to net cash used in operating activities: | |||||||||
| Gain on deconsolidation of Asterias | - | (49,048 | ) | ||||||
| Gain on deconsolidation of OncoCyte | (71,697 | ) | - | ||||||
| Unrealized (gain) loss on equity method investment in Asterias at fair value | 26,097 | (26,532 | ) | ||||||
| Unrealized gain on equity method investment in OncoCyte at fair value | (39,620 | ) | - | ||||||
| Deferred income tax expense | 4,772 | - | |||||||
| Depreciation expense, including amortization of leasehold improvements | 670 | 996 | |||||||
| Amortization of intangible assets | 1,766 | 2,935 | |||||||
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Amortization of deferred license fees |
(166 |
) |
1,191 |
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| Stock-based compensation | 2,903 | 6,303 | |||||||
| Subsidiary shareholder expense for subsidiary warrants | 531 | 3,125 | |||||||
| Amortization of discount on related party convertible debt | 640 | 264 | |||||||
| BioTime's share of losses in equity method investment in Ascendance | - | 1,189 | |||||||
| Foreign currency remeasurement (gain) or loss and other | (1,511 | ) | 802 | ||||||
| Gain on sale of assets | (1,754 | ) | - | ||||||
| Loss on extinguishment of related party convertible debt | 2,799 | - | |||||||
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| Changes in operating assets and liabilities: | |||||||||
| Accounts and grants receivable, net | (905 | ) | (955 | ) | |||||
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Deferred revenue and other liabilities |
(279 | ) |
509 |
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|||||
| Receivables from affiliates, net of payables | 760 | - | |||||||
| Prepaid expenses and other current assets | 93 | (1,013 | ) | ||||||
| Accounts payable and accrued liabilities | 1,276 |
399 |
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| Net cash used in operating activities | (24,842 | ) | (33,474 | ) | |||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||||
| Deconsolidation of cash and cash equivalents of OncoCyte | (8,898 | ) | - | ||||||
| Deconsolidation of cash and cash equivalents of Asterias | - | (8,376 | ) | ||||||
| Purchase of equipment and other assets | (930 | ) | (1,860 | ) | |||||
| Payments on construction in progress | - | (278 | ) | ||||||
| Proceeds from sale of assets and other | 186 | 34 | |||||||
| Cash used in investing activities | (9,642 | ) | (10,480 | ) | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||||
| Proceeds from issuance of common shares | 20,125 | 20,125 | |||||||
| Fees paid on sale of common shares | (1,623 | ) | (1,515 | ) | |||||
| Proceeds from sale of common shares of subsidiary | 9,968 | - | |||||||
| Proceeds from exercises of stock options | 29 | 2,015 | |||||||
| Reimbursement from landlord on construction in progress | 198 | 451 | |||||||
| Shares retired to pay for employees’ taxes | (38 | ) | - | ||||||
| Repayment of capital lease obligation | (31 | ) | (104 | ) | |||||
| Proceeds from sale of common shares and warrants of subsidiary | - | 10,721 | |||||||
| Fees paid on sale of common shares and warrants of subsidiary | - | (904 | ) | ||||||
| Proceeds from issuance of related party convertible debt | 384 | 1,150 | |||||||
| Net cash provided by financing activities | 29,012 | 31,939 | |||||||
| Effect of exchange rate changes on cash and cash equivalents | 46 | 237 | |||||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (5,426 | ) | (11,778 | ) | |||||
| CASH AND CASH EQUIVALENTS: | |||||||||
| At beginning of the period | 22,088 | 42,229 | |||||||
| At end of the period | $ | 16,662 | $ | 30,451 | |||||
Non-GAAP Financial Measures
This earnings release includes operating expenses prepared in accordance with accounting principles generally accepted in
Furthermore, management uses these non-GAAP financial measures in the aggregate and on an entity basis to establish budgets and operational goals, to manage BioTime’s business and to evaluate its performance and its programs in clinical development.
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BIOTIME, INC. AND SUBSIDIARIES RECONCILIATION OF NON-GAAP FINANCIAL MEASURE ADJUSTED OPERATING EXPENSES |
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Amounts In Thousands | |||||||
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For the Three Months |
For the Nine Months |
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| GAAP Operating Expenses - as reported | $ | 11,149 | $ | 33,438 | ||||
| Stock-based and other noncash compensation expense (1) | (1,711 | ) | (4,179 | ) | ||||
| Depreciation and amortization expense (1) | (831 | ) | (2,436 | ) | ||||
| Non-GAAP Operating Expenses, as adjusted | $ | 8,607 | $ | 26,823 | ||||
| GAAP Operating Expenses - by entity | ||||||||
| BioTime and subsidiaries other than AgeX Therapeutics, Inc. | $ | 8,875 | $ | 24,022 | ||||
| AgeX Therapeutics Inc. and subsidiaries | 2,264 | 6,693 | ||||||
| LifeMap Solutions, Inc. | 10 | 1,335 | ||||||
| OncoCyte results for the period from January 1 through February 16, 2017 | - | 1,388 | ||||||
| GAAP Operating Expenses - by entity | $ | 11,149 | $ | 33,438 | ||||
| Non-GAAP Operating Expenses - as adjusted, by entity | ||||||||
| BioTime and subsidiaries other than AgeX Therapeutics, Inc. (2) | $ | 6,459 | $ | 18,275 | ||||
| AgeX Therapeutics Inc. and subsidiaries (3) | 2,138 | 6,237 | ||||||
| LifeMap Solutions (4) | 10 | 1,126 | ||||||
| OncoCyte results for the period from January 1 through February 16, 2017 (5) | - | 1,185 | ||||||
| Non-GAAP Operating Expenses - as adjusted, by entity | $ | 8,607 | $ | 26,823 | ||||
| (1) | Noncash charges | |
| (2) | BioTime, Inc. includes Cell Cure Neurosciences Ltd., ES Cell International Pte. Ltd. and OrthoCyte Corporation. The GAAP and non-GAAP operating expenses do not include $1.4 million in grants receivable as of September 30, 2017 as grants are revenues for the Company. | |
| (3) | AgeX Therapeutics, Inc. includes LifeMap Sciences Inc., LifeMap Sciences Ltd., and ReCyte Therapeutics, Inc. and certain R&D departments related to AgeX projects that were transferred from BioTime to AgeX effective July 1, 2017 | |
| (4) | Entities whose operating expenses will not recur in the future | |
| (5) | OncoCyte’s results for the period from January 1 through February 16, 2017, the date immediately before the OncoCyte Deconsolidation included in BioTime’s consolidated results, which are not going to recur |
View source version on businesswire.com: http://www.businesswire.com/news/home/20171109006496/en/
Source:
Investor Contact:
BioTime, Inc.
David Nakasone, 510-871-4188
dnakasone@biotimeinc.com
or
Media Contact:
JQA Partners, Inc.
Jules Abraham, 917-885-7378
jabraham@jqapartners.com