CARLSBAD, Calif., April 10, 2018 (GLOBE NEWSWIRE) -- via NetworkWire -- International Stem Cell Corporation (ISCO, Financial) (www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, today provided a business update and announced fourth quarter and year-end financial results for the period ending on December 31, 2017.
"In 2017 we made significant progress towards our business unit optimization and have managed to decrease operating cash burn by nearly fifty percent, all while conducting the world’s first clinical trial of neural stem cells in Parkinson’s disease patients. We recently completed stem cell transplantation in the second cohort of our patients and expect to initiate phase II before year’s end" stated Andrey Semechkin, Ph.D., CEO and Co-Chairman of ISCO. "We still face challenges, but I believe that our cutting-edge therapy and innovative commercial products, as well as seasoned executive team, will lead us to future success,” he continued.
FY 2017 Financial highlights:
- Revenues increased to $7.5 million in 2017 compared to $7.2 million in 2016 ;
- Combined operating income for the year ended December 31, 2017 from our two wholly owned revenue generating subsidiaries, Lifeline Cell Technology and Lifeline Skin Care, was $1.4 million, compared to $1.3 million in 2016
- Average net cash used in operating activities was approximately $179,000 per month for the year ended December 31, 2017, a decrease of 49%, compared to $350,000 in 2016;
- Gross margins declined 1% year over year to 72% in 2017, compared to 73% in 2016
Recent Corporate Highlights
- The second cohort of patients in the clinical trial for Parkinson's disease was successfully transplanted with 50,000,000 ISC-hpNSC® cells
- 13 pending patent applications covering internally-generated and in-licensed technologies were issued as patents
2018 Anticipated Events
- Complete dosing patients in phase I Parkinson's disease clinical trial
- Announce full safety results from the first cohort of patients currently in phase I of the Parkinson's disease clinical trial
- Commence phase II clinical study of ISC-hpNSC® for the treatment of Parkinson’s disease
- Initiate phase II clinical study of ISC-hpNSC® for the treatment of traumatic brain injury
- Publish pre-clinical data for traumatic brain injury program
- Receipt of US patent for manufacturing ISC-hpNSC®
Presentations
In 2017, the Company presented positive interim results of its clinical trial in Parkinson's disease at the following events:
- The American Society for Neural Therapy and Repair Annual Meeting;
- The American Society of Gene and Cell Therapy 20th Annual Meeting;
- The Society for Neuroscience Annual Meeting (Neuroscience 2017).
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments and company achievements, expected clinical studies (including timing and results), progress of research and development, and other opportunities for the company 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 to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain capital, application of capital resources among competing uses, 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 Company's business, particularly those mentioned in the cautionary statements found in the Company's Securities and Exchange Commission filings. The Company disclaims any intent or obligation to update forward-looking statements.
International Stem Cell Corporation and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share data)
| December 31, | December 31, | |||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 304 | $ | 110 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $12 | 465 | 574 | ||||||
| Inventory, net | 1,307 | 1,390 | ||||||
| Prepaid expenses and other current assets | 779 | 418 | ||||||
| Total current assets | 2,855 | 2,492 | ||||||
| Non-current inventory | 692 | 615 | ||||||
| Property and equipment, net | 321 | 396 | ||||||
| Intangible assets, net | 2,922 | 3,484 | ||||||
| Deposits and other assets | 74 | 58 | ||||||
| Total assets | $ | 6,864 | $ | 7,045 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Accounts payable | $ | 830 | $ | 841 | ||||
| Accrued liabilities | 607 | 465 | ||||||
| Advances | 250 | 250 | ||||||
| Fair value of warrant liability | 3,113 | 2,045 | ||||||
| Total current liabilities | 4,800 | 3,601 | ||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders' Equity | ||||||||
| Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 250,000 issued and outstanding, with liquidation preferences of $396 and $381 at December 31, 2017 and 2016, respectively | — | — | ||||||
| Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 shares issued and outstanding, with liquidation preference of $4,320 | — | — | ||||||
| Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and outstanding, with liquidation preference of $5,000 | 5 | 5 | ||||||
| Series I-1 Convertible Preferred stock, $0.001 par value, 2,000 shares authorized, 1,304 and 1,680 issued and outstanding with liquidation preferences of $1,304 and $1,680 at December 31, 2017 and 2016, respectively | — | — | ||||||
| Series I-2 Convertible Preferred stock, $0.001 par value, 4,310 shares authorized, issued and outstanding with liquidation preferences of $4,310 at December 31, 2017 and 2016 | — | — | ||||||
| Common stock, $0.001 par value, 120,000,000 shares authorized, 6,057,132 and 3,950,979 shares issued and outstanding at December 31, 2017 and 2016, respectively | 6 | 4 | ||||||
| Additional paid-in capital | 106,585 | 101,898 | ||||||
| Accumulated deficit | (104,532 | ) | (98,463 | ) | ||||
| Total stockholders' equity | 2,064 | 3,444 | ||||||
| Total liabilities and stockholders' equity | $ | 6,864 | $ | 7,045 | ||||
International Stem Cell Corporation and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
| Years Ended | ||||||||
| December 31, | ||||||||
| 2017 | 2016 | |||||||
| Revenues | ||||||||
| Product sales | $ | 7,456 | $ | 7,165 | ||||
| Total revenues | 7,456 | 7,165 | ||||||
| Expenses | ||||||||
| Cost of sales | 2,122 | 1,944 | ||||||
| Research and development | 2,658 | 2,856 | ||||||
| Selling and marketing | 2,405 | 2,527 | ||||||
| General and administrative | 5,213 | 4,689 | ||||||
| Total expenses | 12,398 | 12,016 | ||||||
| Loss from operations | (4,942 | ) | (4,851 | ) | ||||
| Other income (expense) | ||||||||
| Change in fair value of warrant liability | (1,068 | ) | 14,607 | |||||
| Fair value of warrant liability in excess of proceeds | — | (9,902 | ) | |||||
| Financing transaction costs | — | (928 | ) | |||||
| Interest expense | (59 | ) | (6 | ) | ||||
| Miscellaneous income | — | 1 | ||||||
| Total other income (expense), net | (1,127 | ) | 3,772 | |||||
| Loss before provision for income taxes | (6,069 | ) | (1,079 | ) | ||||
| Provision for income taxes | — | — | ||||||
| Net loss | $ | (6,069 | ) | $ | (1,079 | ) | ||
| Net loss applicable to common stockholders | $ | (6,069 | ) | $ | (1,079 | ) | ||
| Net loss per common share-basic | $ | (1.46 | ) | $ | (0.34 | ) | ||
| Net loss per common share-diluted | $ | (1.46 | ) | $ | (0.34 | ) | ||
| Weighted average shares outstanding-basic | 4,158 | 3,190 | ||||||
| Weighted average shares outstanding-diluted | 4,158 | 3,190 | ||||||
International Stem Cell Corporation
Russell Kern, PhD
Executive Vice President, CSO
(760) 940-6383
[email protected]
