CARLSBAD, Calif., Aug. 15, 2018 (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 six months ended June 30, 2018.
“I’m pleased with our progress as ISCO continues to move forward actively in several areas. Recently we achieved another
important milestone: transplanting the highest number of neural stem cells to the first Parkinson’s disease patient in the third
cohort of patients in our phase 1 clinical trial. We plan to announce the 6 month results from the second cohort of patients before
the end of Q3. Our financial results also show stable growth, and we were able to achieve record sales and to significantly
decrease our loss from operations,” said Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.
Year-to-Date Financial Highlights
- Consolidated revenue for the six months ended June 30, 2018 was $5.7 million, an increase of 50% compared to the consolidated
revenue of $3.8 million for the six months ended June 30, 2017.
- Gross profit margin for the Company's revenue-generating subsidiaries for the six months ended June 30, 2018 was $3.8
million, compared to gross profit margin of $2.7 million for the six months ended June 30, 2017.
- Combined operating income for the six months ended June 30, 2018 from our two wholly owned revenue generating subsidiaries
was $1.5 million, an increase of 53% compared to $974,000 in the same period in 2017.
- Consolidated loss before income taxes, including from Parkinson's disease clinical trial expenses, for the six months ended
June 30, 2018 was $1.2 million, compared to consolidated loss before income taxes of $2.5 million for the same period in
2017
- Average net cash used in operating activities, excluding capital expenditures and patent costs, was approximately $93,000 per
month during the six months ended June 30, 2018, a decrease of 58%, compared to $222,000 per month for the same period in
2017.
Recent Corporate and Clinical Trial Highlights
- Successfully transplanted the first patient in the third cohort of patients in the clinical trial for Parkinson's disease.
The patient received 70,000,000 ISC-hpNSC® cells.
- Published two papers in scientific peer-reviewed journals. One paper, entitled "Novel Approach to Stem Cell Therapy in
Parkinson's Disease," was published in Stem Cells and Development, a premier peer-reviewed journal of
clinical, basic, and translational research on stem cells and their potential therapeutic applications. Another paper, entitled
"Supplementation of Specific Carbohydrates Results in Enhanced Deposition of Chondrogenic-Specific Matrix during Mesenchymal Stem
Cell Differentiation," was published in the Journal of Tissue Engineering and Regenerative Medicine, a prestigious
peer-reviewed scientific journal. Due to its scientific relevance, the article was featured on the cover of the journal's May
2018 issue.
- Developed a novel method that efficiently generates human 3D liver-like tissue. The 3D liver structures are produced from
human pluripotent stem cell derived-liver progenitor cells. As these cells differentiate in 3D culture, they form liver-like
tissue that consists of hepatocytes, choangiocytes, and hepatic stellate cells.
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 results of 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) |
| |
| |
|
June 30, |
|
|
December 31, |
|
| |
|
2018 |
|
|
2017 |
|
| Assets |
|
(Unaudited) |
|
|
|
|
|
| Cash |
|
$ |
477 |
|
|
$ |
304 |
|
| Accounts receivable, net of allowance for doubtful accounts of
$12 |
|
|
1,614 |
|
|
|
465 |
|
| Inventory, net |
|
|
1,682 |
|
|
|
1,307 |
|
| Prepaid expenses and other current assets |
|
|
567 |
|
|
|
779 |
|
| Total current assets |
|
|
4,340 |
|
|
|
2,855 |
|
| Non-current inventory |
|
|
718 |
|
|
|
692 |
|
| Property and equipment, net |
|
|
384 |
|
|
|
321 |
|
| Intangible assets, net |
|
|
2,910 |
|
|
|
2,922 |
|
| Deposits and other assets |
|
|
64 |
|
|
|
74 |
|
| Total assets |
|
$ |
8,416 |
|
|
$ |
6,864 |
|
| Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
| Accounts payable |
|
$ |
1,817 |
|
|
$ |
830 |
|
| Accrued liabilities |
|
|
819 |
|
|
|
607 |
|
| Related party payable |
|
|
1,108 |
|
|
|
— |
|
| Advances |
|
|
250 |
|
|
|
250 |
|
| Fair value of warrant liability |
|
|
2,779 |
|
|
|
3,113 |
|
| Total current liabilities |
|
|
6,773 |
|
|
|
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 $402 and $396 at June 30, 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,
1,094 and
1,304 issued and outstanding, with liquidation preferences of $1,094 and $1,304 at
June 30, 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, 6,295,888 and
6,057,132
shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively |
|
|
6 |
|
|
|
6 |
|
| Additional paid-in capital |
|
|
107,388 |
|
|
|
106,585 |
|
| Accumulated deficit |
|
|
(105,756 |
) |
|
|
(104,532 |
) |
| Total stockholders' equity |
|
|
1,643 |
|
|
|
2,064 |
|
| Total liabilities and stockholders' equity |
|
$ |
8,416 |
|
|
$ |
6,864 |
|
| International Stem Cell Corporation and
Subsidiaries |
| Condensed Consolidated Statements of
Operations |
| (in thousands, except per share
data) |
| (Unaudited) |
| |
| |
Three Months Ended |
|
|
Six Months Ended |
|
| |
June 30, |
|
|
June 30, |
|
| |
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
| Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Product sales |
$ |
3,038 |
|
|
$ |
1,762 |
|
|
$ |
5,671 |
|
|
$ |
3,767 |
|
| Total revenues |
|
3,038 |
|
|
|
1,762 |
|
|
|
5,671 |
|
|
|
3,767 |
|
| Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Cost of sales |
|
1,095 |
|
|
|
471 |
|
|
|
1,920 |
|
|
|
1,024 |
|
| Research and development |
|
452 |
|
|
|
739 |
|
|
|
1,263 |
|
|
|
1,384 |
|
| Selling and marketing |
|
624 |
|
|
|
557 |
|
|
|
1,332 |
|
|
|
1,133 |
|
| General and administrative |
|
1,233 |
|
|
|
997 |
|
|
|
2,707 |
|
|
|
2,274 |
|
| Total expenses |
|
3,404 |
|
|
|
2,764 |
|
|
|
7,222 |
|
|
|
5,815 |
|
| Loss from operations |
|
(366 |
) |
|
|
(1,002 |
) |
|
|
(1,551 |
) |
|
|
(2,048 |
) |
| Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Change in fair value of warrant liability |
|
(21 |
) |
|
|
1,584 |
|
|
|
334 |
|
|
|
(448 |
) |
| Interest expense |
|
(7 |
) |
|
|
(14 |
) |
|
|
(9 |
) |
|
|
(20 |
) |
| Miscellaneous income |
|
1 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
| Total other income (expense) |
|
(27 |
) |
|
|
1,570 |
|
|
|
327 |
|
|
|
(468 |
) |
| Income (loss) before income taxes |
|
(393 |
) |
|
|
568 |
|
|
|
(1,224 |
) |
|
|
(2,516 |
) |
| Provision for income taxes |
|
— |
|
|
— |
|
|
|
— |
|
|
— |
|
| Net income (loss) |
$ |
(393 |
) |
|
$ |
568 |
|
|
$ |
(1,224 |
) |
|
$ |
(2,516 |
) |
| Net income (loss) applicable to common stockholders |
$ |
(393 |
) |
|
$ |
568 |
|
|
$ |
(1,224 |
) |
|
$ |
(2,516 |
) |
| Net income (loss) per common share-basic |
$ |
(0.06 |
) |
|
$ |
0.14 |
|
|
$ |
(0.20 |
) |
|
$ |
(0.63 |
) |
| Net loss per common share-diluted |
$ |
(0.06 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.63 |
) |
| Weighted average shares-basic |
|
6,225 |
|
|
|
3,996 |
|
|
|
6,181 |
|
|
|
3,974 |
|
| Weighted average shares-diluted |
|
6,225 |
|
|
|
4,017 |
|
|
|
6,181 |
|
|
|
3,974 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
International Stem Cell Corporation
Russell Kern, PhD
Executive Vice President, CSO
Phone: 760-940-6383
Email: ir@intlstemcell.com
