SAN DIEGO, CA / ACCESSWIRE / March 30, 2022 / International Stem Cell Corporation (OTCQX: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 fourth quarter and year-end financial results for the period ending on December 31, 2021.
"We are pleased with the outcome of our phase 1 clinical trial as we were able to show not only safety and tolerability, but also preliminary efficacy for ISC-hpNSC®. As an example, on average the quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 Summary Index, improved 43% for the second cohort at twelve months post-transplantation. This improved to a 45% better score in the same at 48 months" stated Andrey Semechkin, Ph.D., CEO and Co-Chairman of ISCO.
FY 2021 Financial Highlights:
- Revenues slightly increased to $7.18 million in 2021 compared to $7.13 million in 2020.
- Combined operating income for the year ended December 31, 2021, from our two wholly owned revenue generating subsidiaries, Lifeline Cell Technology and Lifeline Skin Care, increased to $1.35 million, an increase of 127%, compared to $592,000 in 2020.
- Net loss decreased to $899,000 for the year ended December 31, 2021, a decrease of 67%, compared to $2.72 million in 2020.
Top-line Parkinson's Disease Clinical Trial Results
ISCO successfully completed the treatment phase of its dose escalating phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT02452723) evaluating the safety, tolerability, and preliminary efficacy of its lead candidate, ISC-hpNSC® for the treatment of Parkinson's disease (PD). Patients treated with the mid dose (cohort 2) have been observed for at least 36 months and patients in the low dose group (Cohort 1) have been followed for 48 months post transplantation. In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose. The % OFF-Time, which is the time during the day when levodopa medication is not performing optimally and PD symptoms return, decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the %OFF time in the second cohort dropped by 55% from the initial reading. The same was true for % ON-Time without dyskinesia, which is the time during the day when levodopa medication is performing optimally without dyskinesia. The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort. The %ON result improved in the second cohort to 65% above the baseline in month 24. The quality of life of the patients as measured by the Parkinson's Disease Quality of Life Score-39 (PDQ-39) Summary Index, improved 43% for the second cohort at twelve months post-transplantation. This improved to a 45% better score in cohort 2 at 48 months.
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 results and ongoing evaluation of the phase 1 clinical trial), 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 and par value data)
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 171 | $ | 689 | ||||
Accounts receivable, net | 844 | 403 | ||||||
Inventory, net | 1,184 | 917 | ||||||
Prepaid expenses and other current assets | 135 | 174 | ||||||
Total current assets | 2,334 | 2,183 | ||||||
Non-current inventory, net | 372 | 371 | ||||||
Property and equipment, net | 384 | 534 | ||||||
Intangible assets, net | 949 | 1,262 | ||||||
Right-of-use assets | 868 | 874 | ||||||
Deposits and other assets | 39 | 63 | ||||||
Total assets | $ | 4,946 | $ | 5,287 | ||||
Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 508 | $ | 360 | ||||
Accrued liabilities | 404 | 386 | ||||||
Operating lease liabilities, current | 179 | 346 | ||||||
Advances | 250 | 250 | ||||||
Related party note payable | 2,943 | - | ||||||
Paycheck Protection Program loan, current | - | 141 | ||||||
Total current liabilities | 4,284 | 1,483 | ||||||
Related party note payable | - | 2,475 | ||||||
Paycheck Protection Program loan, net of current portion | - | 517 | ||||||
Operating lease liabilities, net of current portion | 950 | 845 | ||||||
Total liabilities | 5,234 | 5,320 | ||||||
Commitments and contingencies (Note 11) | ||||||||
Series D redeemable convertible preferred stock, $0.001 par value; 50 shares authorized; 43 shares issued and outstanding; liquidation preference of $4,300 at December 31, 2021 and 2020 | 4,300 | 4,300 | ||||||
Stockholders' Deficit: | ||||||||
Non-redeemable convertible preferred stock, $0.001 par value; 10,004,310 and 10,006,310 shares authorized, 5,254,310 and 5,255,124 shares issued and outstanding, liquidation preference of $9,766 and $10,565 at December 31, 2021 and December 31, 2020, respectively | 5 | 5 | ||||||
Common stock, $0.001 par value; 120,000,000 shares authorized; 8,004,389 and 7,539,089 shares issued and outstanding at December 30, 2021 and 2020, respectively | 8 | 8 | ||||||
Additional paid-in capital | 105,413 | 104,769 | ||||||
Accumulated deficit | (110,014 | ) | (109,115 | ) | ||||
Total stockholders' deficit | (4,588 | ) | (4,333 | ) | ||||
Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $ | 4,946 | $ | 5,287 | ||||
International Stem Cell Corporation and Subsidiaries
Consolidated Statements of Operations
(In thousands, except per share data)
| Years Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
Product sales | $ | 7,176 | $ | 7,128 | ||||
Operating expenses: | ||||||||
Cost of sales | 2,935 | 2,781 | ||||||
General and administrative | 4,084 | 4,422 | ||||||
Selling and marketing | 1,383 | 1,755 | ||||||
Research and development | 695 | 988 | ||||||
Total operating expenses | 9,097 | 9,946 | ||||||
Loss from operations | (1,921 | ) | (2,818 | ) | ||||
Other income (expense): | ||||||||
Gain on forgiveness of debt | 1,137 | - | ||||||
Change in fair value of warrant liability | - | 207 | ||||||
Interest expense | (128 | ) | (113 | ) | ||||
Other income, net | 13 | - | ||||||
Total other income, net | 1,022 | 94 | ||||||
Net loss | $ | (899 | ) | $ | (2,724 | ) | ||
Net loss per common share, basic and diluted | $ | (0.11 | ) | $ | (0.36 | ) | ||
Weighted-average common shares used to compute net loss per share, basic and diluted | 7,833 | 7,539 | ||||||
Contacts:
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com
SOURCE: International Stem Cell CORP
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