CARLSBAD, Calif., May 17, 2019 (GLOBE NEWSWIRE) -- International Stem Cell Corporation (OTCQB:ISCO) (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 announcing operating results for the three months ended March 31, 2019.
"In Q1 2019 we recently achieved a major milestone in the world's first approved human pluripotent stem cell-based clinical trial for the treatment of Parkinson's disease. We completed enrollment and treatment of all patients with our lead therapeutic product ISC-hpNSC® cells. Based on the available data, we believe that the therapy is safe and well tolerated, meeting the primary endpoint of the phase 1 clinical trial. In connection with the conclusion of the treatment phase of the study, we anticipate the clinical trial-related expenses to significantly decrease," commented Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.
Q1 2019 Financial Highlights
- Consolidated revenue for the first quarter of 2019 was $2.2 million, a decrease of 15% compared to the consolidated revenue of $2.6 million for the first quarter of 2018.
- Combined operating income for the quarter ended March 31, 2019 from our two wholly owned revenue generating subsidiaries was $169,000, a decrease of 73% compared to $631,000 in the first quarter of 2018.
- Net loss for ISCO was $906,000 for the first quarter of 2019 compared to a net loss of $830,000 million for the first quarter in 2018, an increase of 9 %.
Recent Clinical Trial Highlights
- ISCO completed subject enrollment in its phase 1 clinical trial of ISC-hpNSC® for the treatment of Parkinson's disease. The fourth subject of the third cohort, who was the twelfth and final subject of the phase 1 clinical study, was successfully transplanted with the highest dose of ISC-hpNSC® cells.
- Presented interim clinical results at the American Academy of Neurology annual meeting in Philadelphia, PA.
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).
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Safe harbor statement
Statements pertaining to anticipated developments and company achievements, expected clinical studies (including timing and results), anticipated protection from patents, and trends in clinical trial related expenses, 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
Condensed Consolidated Balance Sheets
(in thousands, except share data and par value)
| | | March 31, | | | December 31, | |
| | | 2019 | | | 2018 | |
| Assets | | (Unaudited) | | | | | |
| Cash | | $ | 615 | | | $ | 1,075 | |
| Accounts receivable, net of allowance for doubtful accounts of $12 | | | 957 | | | | 651 | |
| Inventory, net | | | 1,460 | | | | 1,501 | |
| Prepaid expenses and other current assets | | | 480 | | | | 543 | |
| Total current assets | | | 3,512 | | | | 3,770 | |
| Non-current inventory | | | 792 | | | | 805 | |
| Property and equipment, net | | | 652 | | | | 469 | |
| Intangible assets, net | | | 2,700 | | | | 2,674 | |
| Right-of-use asset | | | 933 | | | | — | |
| Deposits and other assets | | | 74 | | | | 78 | |
| Total assets | | $ | 8,663 | | | $ | 7,796 | |
| Liabilities and Stockholders' Equity | | | | | | | | |
| Accounts payable | | $ | 806 | | | $ | 458 | |
| Accrued liabilities | | | 959 | | | | 579 | |
| Operating lease liability, current | | | 294 | | | | — | |
| Related party payable | | | 1,009 | | | | 2,045 | |
| Advances | | | 250 | | | | 250 | |
| Fair value of warrant liability | | | 1,148 | | | | 1,745 | |
| Total current liabilities | | | 4,466 | | | | 5,077 | |
| Long-term deferred rent | | | — | | | | 182 | |
| Operating lease liability, net of current portion | | | 1,011 | | | | — | |
| Total liabilities | | | 5,477 | | | | 5,259 | |
| Commitments and Contingencies | | | | | | | | |
| 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 $415 and $411 at March 31, 2019
and December 31, 2018, respectively | | | — | | | | — | |
Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 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, 814 issued and
outstanding, with liquidation preferences of $814 | | | — | | | | — | |
Series I-2 Convertible Preferred stock, $0.001 par value, 4,310 shares authorized,
issued and outstanding with liquidation preference of $4,310 | | | — | | | | — | |
Common stock, $0.001 par value, 120,000,000 shares authorized, 7,533,083 and 6,933,861 shares
issued and outstanding at March 31, 2019 and December 31, 2018, respectively | | | 8 | | | | 7 | |
| Additional paid-in capital | | | 110,742 | | | | 109,188 | |
| Accumulated deficit | | | (107,569 | ) | | | (106,663 | ) |
| Total stockholders' equity | | | 3,186 | | | | 2,537 | |
| Total liabilities and stockholders' equity | | $ | 8,663 | | | $ | 7,796 | |
| | | | | | | | | |
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
| | Three Months Ended | | |
| | March 31, | | |
| | 2019 | | | 2018 | | |
| Revenues | | | | | | | | |
| Product sales | $ | 2,218 | | | $ | 2,633 | | |
| Total revenues | | 2,218 | | | | 2,633 | | |
| Expenses | | | | | | | | |
| Cost of sales | | 841 | | | | 825 | | |
| Research and development | | 653 | | | | 811 | | |
| Selling and marketing | | 692 | | | | 708 | | |
| General and administrative | | 1,521 | | | | 1,474 | | |
| Total expenses | | 3,707 | | | | 3,818 | | |
| Loss from operations | | (1,489 | ) | | | (1,185 | ) | |
| Other income (expense) | | | | | | | | |
| Change in fair value of warrant liability | | 597 | | | | 355 | | |
| Interest expense | | (14 | ) | | | (2 | ) | |
| Miscellaneous income | | — | | | | 2 | | |
| Total other income (expense), net | | 583 | | | | 355 | | |
| Loss before provision for income taxes | | (906 | ) | | | (830 | ) | |
| Provision for income taxes | | — | | | — | | |
| Net loss | $ | (906 | ) | | $ | (830 | ) | |
Net loss applicable to common
stockholders | $ | (906 | ) | | $ | (830 | ) | |
| Net loss per common share-basic | $ | (0.12 | ) | | $ | (0.14 | ) | |
| Net (loss) per common share-diluted | $ | (0.12 | ) | | $ | (0.14 | ) | |
| Weighted average shares-basic | | 7,400 | | | | 6,136 | | |
| Weighted average shares-diluted | | 7,400 | | | | 6,136 | | |
| | | | | | | | | |
Contacts:
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com
Joe Green
Investor Relations
Edison Inc.
jgreen@edisongroup.com
+1 (646) 653-7030
