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International Stem Cell Corporation Announces Operating Results for the Three and Nine-Months ended September 30, 2017

CARLSBAD, Calif., Nov. 17, 2017 (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 and announced operating results for the three and nine months ending on September 30, 2017.

“Our business indicators have undergone significant improvement, while cash burn has significantly declined,” said Andrey Semechkin, PhD, Co-Chairman and CEO of ISCO. “At the recent Society of Neuroscience annual meeting held in Washington DC, we presented positive six-month interim results of the first cohort of Parkinson's disease patients and were pleased to announce that all patients in the first cohort are currently meeting the primary endpoint,” he continued.

Year-to-Date Financial Highlights

  • Combined operating income for the nine months ended September 30, 2017 from our two wholly owned revenue-generating subsidiaries was $1.3 million, an increase of 30% compared to $1.0 million in the same period in 2016.
  • Consolidated revenue for the nine months ended September 30, 2017 was $5.6 million, compared to the consolidated revenue of $5.5 million for the nine months ended September 30, 2016.
  • Gross profit margin for the Company’s revenue-generating subsidiaries for the nine months ended September 30, 2017 was $4.1 million, or 73%, compared to gross profit margin of $4.0 million, or 73%, for the nine months ended September 30, 2016.
  • Consolidated loss from operations, including phase I Parkinson’s disease clinical trial expenses, for the nine months ended September 30, 2017 was $3.0 million, compared to consolidated loss from operations of $3.7 million for the same period in 2016.
  • Average net cash used in operating activities was approximately $183,000 per month during the nine months ended September 30, 2017, a decrease of 49%, compared to $362,000 per month for the same period in 2016.

Recent R&D Highlights

  • The fifth and sixth patients (the first and second patients of the second cohort) in the clinical trial for Parkinson's Disease were successfully transplanted with ISC-hpNSC® cells.
  • Presented positive six-month interim results of the first cohort of Parkinson's disease (PD) patients at the Society for Neuroscience annual meeting. All patients in the first cohort are currently meeting the primary endpoint, which is safety.
  • Developed a 3D bioprinting technology that utilizes proprietary liver progenitor cells, which can be differentiated into cholangiocytes, hepatocytes and stellate cells in vitro.

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, 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)
September 30, December 31,
2017 2016
Assets(Unaudited)
Cash and cash equivalents$510 $110
Accounts receivable, net of allowance for doubtful accounts of $12 684 574
Inventory, net 1,352 1,390
Prepaid expenses and other current assets 587 418
Total current assets 3,133 2,492
Non-current inventory 701 615
Property and equipment, net 339 396
Intangible assets, net 3,706 3,484
Deposits and other assets 74 58
Total assets$7,953 $7,045
Liabilities and Stockholders' Equity (Deficit)
Accounts payable$848 $841
Accrued liabilities 624 465
Related party payable 2,750
Advances 250 250
Fair value of warrant liability 3,667 2,045
Total current liabilities 8,139 3,601
Commitments and contingencies
Stockholders' Equity (Deficit)
Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 250,000
issued and outstanding, with liquidation preferences of $393 and $381 at September 30, 2017
and December 31, 2016, 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, 1,450 and 1,680
issued and outstanding at September 30, 2017 and December 31, 2016, respectively, with
liquidation preferences of $1,450 and $1,680 at September 30, 2017 and December 31, 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
Common stock, $0.001 par value, 120,000,000 shares authorized, 4,108,047 and 3,950,979 shares
issued and outstanding at September 30, 2017 and December 31, 2016, respectively
4 4
Additional paid-in capital 102,948 101,898
Accumulated deficit (103,143) (98,463)
Total stockholders' equity (deficit) (186) 3,444
Total liabilities and stockholders' equity (deficit)$7,953 $7,045


International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Revenues
Product sales$1,847 $1,943 $5,614 $5,475
Total revenue 1,847 1,943 5,614 5,475
Expenses
Cost of sales 474 606 1,498 1,489
Research and development 670 679 2,054 2,110
Selling and marketing 657 605 1,790 1,904
General and administrative 1,016 1,315 3,290 3,650
Total expenses 2,817 3,205 8,632 9,153
Loss from operations (970) (1,262) (3,018) (3,678)
Other income (expense)
Change in fair value of warrant liability (1,174) 1,676 (1,622) 11,273
Fair value of warrant liability in excess of proceeds (9,902)
Financing transaction costs (928)
Interest expense (20) (40) (6)
Miscellaneous income 1
Total other income (expense), net (1,194) 1,676 (1,662) 438
Income (loss) before income taxes (2,164) 414 (4,680) (3,240)
Provision for income taxes
Net income (loss)$(2,164) $414 $(4,680) $(3,240)
Net income (loss) applicable to common stockholders$(2,164) $414 $(4,680) $(3,240)
Net income (loss) per common share-basic$(0.54) $0.12 $(1.17) $(1.07)
Net income (loss) per common share-diluted$(0.54) $(0.30) $(1.17) $(1.37)
Weighted average shares-basic 4,020 3,330 3,989 3,015
Weighted average shares-diluted 4,020 3,663 3,989 4,210

Contacts:

International Stem Cell Corporation
Russell Kern, PhD
Executive Vice President, CSO

Phone: 760-940-6383
Email: ir@intlstemcell.com

Source:International Stem Cell Corporation