CARLSBAD, Calif., May 22, 2018 (GLOBE NEWSWIRE) -- 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 announcing operating results for the three months ended March 31, 2018.
“This was a successful quarter for us both operationally and financially. We were able to decrease net loss by more than 70% compared to the prior year quarter, as well as successfully move forward with our research and development activities. As a result, we have significantly decreased our cash burn while moving forward with our clinical trial. These outcomes give us confidence in the Company's future,” said Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.
Q1 2018 Financial Highlights
- Consolidated revenue for the first quarter of 2018 was $2.6 million, an increase of 30% compared to the consolidated revenue of $2.0 million for the first quarter of 2017.
- Combined operating income for the quarter ended March 31, 2018 from our two wholly owned revenue generating subsidiaries was $631,000, an increase of 10% compared to $572,000 in the first quarter of 2017.
- Average net cash used in operating activities, excluding capital expenditures and patent costs, was approximately $16,000 per month during the three months ended March 31, 2018, a decrease of 92%, compared to $190,000 per month for the same period in 2017.
- Net loss for ISCO was $830,000 for the first quarter of 2018 compared to a net loss of $3.1 million for the first quarter in 2017, a decrease of 73%.
Recent Clinical Trial Highlights
- The 2nd cohort of patients in the clinical trial for Parkinson's disease was successfully transplanted with 50,000,000 ISC-hpNSC® cells.
- Data Safety Monitoring Board (DSMB), a group of experts monitoring the clinical trial of ISC-hpNSC®, has reviewed the safety data from the 2nd cohort in the clinical trial. The DSMB has authorized the clinical trial to move forward with accelerated enrollment and dose escalation to the 3rd cohort. Recruitment for the 3rd cohort will begin immediately, with patients receiving a higher dose of 70,000,000 ISC-hpNSC®.
- United States Patent and Trademark Office (USPTO) has granted the Company a key patent on the method used to manufacture ISC-hpNSC, which are administered in ISCO's ongoing Parkinson's disease clinical trial, and which can potentially be utilized in therapies to treat traumatic brain injury and stroke.
- Presented Interim Clinical Results at the American Academy of Neurology in Los Angeles, CA.
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, expected clinical studies, 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 future 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)
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | (Unaudited) | |||||||
| Cash | $ | 447 | $ | 304 | ||||
| Accounts receivable, net of allowance for doubtful accounts of $12 | 939 | 465 | ||||||
| Inventory, net | 1,385 | 1,307 | ||||||
| Prepaid expenses and other current assets | 639 | 779 | ||||||
| Total current assets | 3,410 | 2,855 | ||||||
| Non-current inventory | 719 | 692 | ||||||
| Property and equipment, net | 336 | 321 | ||||||
| Intangible assets, net | 2,928 | 2,922 | ||||||
| Deposits and other assets | 75 | 74 | ||||||
| Total assets | $ | 7,468 | $ | 6,864 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Accounts payable | $ | 1,612 | $ | 830 | ||||
| Accrued liabilities | 858 | 607 | ||||||
| Related party payable | 351 | — | ||||||
| Advances | 250 | 250 | ||||||
| Fair value of warrant liability | 2,758 | 3,113 | ||||||
| Total current liabilities | 5,829 | 4,800 | ||||||
| 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 $399 and $396 at March 31, 2018 and December 31, 2017, 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, 1,217 and 1,304 issued and outstanding, with liquidation preferences of $1,217 and $1,304 at March 31, 2018 and December 31, 2017, respectively | — | — | ||||||
| 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, 6,195,160 and 6,057,132 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 6 | 6 | ||||||
| Additional paid-in capital | 106,990 | 106,585 | ||||||
| Accumulated deficit | (105,362 | ) | (104,532 | ) | ||||
| Total stockholders' equity | 1,639 | 2,064 | ||||||
| Total liabilities and stockholders' equity | $ | 7,468 | $ | 6,864 | ||||
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
| Three Months Ended | |||||||
| March 31, | |||||||
| 2018 | 2017 | ||||||
| Revenues | |||||||
| Product sales | $ | 2,633 | $ | 2,005 | |||
| Total revenues | 2,633 | 2,005 | |||||
| Expenses | |||||||
| Cost of sales | 825 | 553 | |||||
| Research and development | 811 | 645 | |||||
| Selling and marketing | 708 | 576 | |||||
| General and administrative | 1,474 | 1,277 | |||||
| Total expenses | 3,818 | 3,051 | |||||
| Loss from operations | (1,185 | ) | (1,046 | ) | |||
| Other income (expense) | |||||||
| Change in fair value of warrant liability | 355 | (2,032 | ) | ||||
| Interest expense | (2 | ) | (6 | ) | |||
| Miscellaneous income | 2 | — | |||||
| Total other income (expense) | 355 | (2,038 | ) | ||||
| Loss before income taxes | (830 | ) | (3,084 | ) | |||
| Provision for income taxes | — | — | |||||
| Net loss | $ | (830 | ) | $ | (3,084 | ) | |
| Net loss applicable to common stockholders | $ | (830 | ) | $ | (3,084 | ) | |
| Net loss per common share-basic and diluted | $ | (0.14 | ) | $ | (0.78 | ) | |
| Weighted average shares-basic and diluted | 6,136 | 3,952 | |||||
Contacts:
International Stem Cell Corporation
Russell Kern, PhD
Executive Vice President, CSO
Phone: 760-940-6383
Email: [email protected]
