Thursday, August 22, 2013

International Stem Cell Corporation Enters into Clinical Research Agreement for Parkinson’s Disease Program

CARLSBAD, CA – (Marketwired) – 08/21/13 – International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell-based therapies, announced today that it has entered into a master clinical research agreement with Duke University to conduct clinical trials research in Parkinson’s disease using ISCO’s innovative neural stem cell product.

Mark Stacy, M.D., Vice Dean for Clinical Research, Neurology at Duke University School of Medicine and an internationally recognized leader in the field of Movement Disorders, including Parkinson’s disease, will be the study’s principal investigator. The research will be coordinated by the Duke Clinical Research Institute (DCRI), the world's largest academic clinical research organization, which is internationally recognized for conducting groundbreaking clinical trials.
 “We are pleased to have the opportunity to conduct the clinical trials related to ISCO’s investigation stem cell therapy in Parkinson’s disease patients,” said Stacy. “Duke has an exceptional clinical trials team and we look forward to characterizing and understanding the safety and efficacy profile of this agent in the clinical trials setting.” 

“We’re tremendously excited to be working with such a world-class clinical research organization as Duke University,” commented Dr. Ruslan Semechkin, Vice President of Research and Development at International Stem Cell Corporation. “Dr. Stacy and his team have made numerous significant contributions in the field of Parkinson’s disease research which together with Duke’s extensive clinical expertise in cell therapy clinical trials and the extensive patient population, gives us an outstanding opportunity to evaluate our revolutionary stem cell therapy.”

Stacy has extensive clinical trials experience, primarily involving neuro-protective and neuro-regenerative therapies and developing biomarkers for early diagnosis in Parkinson’s disease. He has published more than 100 peer-reviewed scientific papers in the field and has served as an advisor to a number of companies. He has participated in more than 100 clinical trials.

ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company’s proprietary histocompatible human pluripotent stem cells. The hPNSC are self-renewing mulitpotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (1) differentiate into dopaminergic neurons and (2) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new and revolutionary opportunity for the treatment of Parkinson’s disease, especially in cases where current dopamine-replacement approaches fail to adequately control the symptoms.

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) hence avoiding 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.

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and products, 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.

To receive ongoing corporate communications via email, visit:  http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell
Contacts:
International Stem Cell Corporation
Dr. Simon Craw, Executive Vice President
Phone: 760-940-6383 
Email: ir@intlstemcell.com

Dr. Ruslan Semechkin, Vice President, R&D
Phone: 760-940-6383
Email: ras@intlstemcell.com

Investor Relations:
MZ Group
Mark McPartland
Senior Vice President
Phone: 212-301-7130
Email: markmcp@mzgroup.us


Monday, August 12, 2013

Transcript for the 2Q 2013 Earning Conforence call posted on Seeking Alpha

Transcript can be found here

http://seekingalpha.com/article/1624342-international-stem-cell-management-discusses-q2-2013-results-earnings-call-transcript

Crystal Research Associates, LLC Issues Executive Informational Overview (EIO) on International Stem Cell Corporation



NEW YORK, NY, Aug 06, 2013 (Marketwired via COMTEX) -- Crystal Research Associates, LLC announced today that it has issued an Executive Informational Overview(R) (EIO) on International Stem Cell Corporation (OTCQB: ISCO).

The full 72-page report is available on Crystal Research Associates' website at http://www.crystalra.com/research-library/international-stem-cell-corporation-isco/


International Stem Cell Corporation Announces Second Quarter 2013 Financial Results

Will host conference call at 11 am ET on August 9, 2013

CARLSBAD, CA - (Marketwired) - August 8, 2013, International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today announced financial results for the three and six months ended June 30, 2013.

Q2 2013 Highlights:

 

·       Revenues increased 38% to $1.46 million over the second quarter of 2012, with Lifeline Cell Technologies sales up 40% and Lifeline Skin Care sales up 36%.  Gross margin improved by 600 basis points to 77%

·    Cash burn, excluding capital expenditures and patent costs, for the first six months of 2013 reduced by 16% compared to the same period of 2012

·       In preparation for the IND-enabling studies and after discussion with the FDA office of Cellular, Tissue and Gene Therapies, ISCO’s R&D team commenced large scale manufacturing of its neural stem cell product using the previously disclosed methodology

·      Results demonstrating the safety of its novel cellular replacement and neuroprotective therapy in a primate model of Parkinson’s disease (PD) were presented at the American Society of Gene & Cell Therapy meeting in Salt Lake City, UT and the International Society of Stem Cell Research in Boston, MA

·       Lifeline Skin Care further expanded into the Asian skin care market by signing distribution agreements to sell its branded anti-aging skin care products in Thailand and Vietnam.


“We continue to focus our research and development efforts on our Parkinson’s disease program. We made further progress in demonstrating the safety of our novel approach of using neural stem cells derived from our histocompatible stem cells to provide neuroprotective benefits and replace dying neurons, moving the program closer to the clinic,” stated Dr. Andrey Semechkin, ISCO’s CEO and Co-chairman.

“I am also pleased to report significant growth in sales from both subsidiaries, demonstrating that our sales and marketing strategies are working.  This growth resulted in a considerable reduction in our net cash burn rate,” Dr. Semechkin concluded.

Three Months Ended June 30, 2013

 

Revenue for the three months ended June 30, 2013 was $1.46 million, an increase of approximately 38% compared to $1.06 million for the same period in 2012.  Sales for Lifeline Skin Care (LSC) and Lifeline Cell Technology (LCT) increased by 36% and 40%, respectively. LSC and LCT accounted for 49% and 51% of total revenue, respectively, in the three months ended June 30, 2013.

 

Cost of sales was $0.33 million, or 23% of revenue, compared to $0.31 million or 29% of revenue in the same period a year ago.  Gross margins improved as a result of efficiencies in the manufacturing and supply chain management and increased sales contribution from higher margin products.

 

General and administrative expenses declined 5% to $1.67 million, driven primarily by lower personnel-related expenses resulting from lower headcount, lower stock-based compensation expenses and lower professional and corporate expenses. Marketing expenses increased 24% compared to the second quarter of 2012 to $0.68 million, reflecting higher spending on advertising and promotions for its skin care business.

 

Six Months Ended June 30, 2013

 

Revenue for the six months ended June 30, 2013 and 2012 was $2.74 million and $2.13 million, respectively. LCT contributed $1.38 million, up 30% from the same period in 2012 and LSC contributed $1.36 million, up 27% from the same period in 2012.

 

Cost of sales for the six months ended June 30, 2013 was $0.66 million or 24% of revenue, compared to $0.64 million or 30% of revenue for the same period in 2012 as a result of continued improvements in efficiency and effectiveness in manufacturing and the management of supply chain in Lifeline Skin Care as well as a shift in sales mix from lower to higher margin products in Lifeline Cell Technology.  Gross profit and gross margin for the first six months of 2013 were $2.08 million and 76% compared to $1.50 million and 70%, respectively, in 2012.

 

Cash and cash equivalents totaled $0.65 million at June 30, 2013, essentially unchanged from $0.65 million as of December 31, 2012. Cash outflows from operations for the first six months of 2013 were $2.89 million, down from $3.46 million in the corresponding period in 2012. The Company received approximately $3.27 million, net of stock issuance costs, from the issuance of 16,325,000 shares of common stock in the first six months of 2013. The Company invested approximately $0.37 million in capital and patent expenditures in the first six months of 2013 compared to $0.45 million in the same period in 2012.

 

As previously announced, subsequent to the end of the second quarter of 2013, the Company completed a financing transaction under an effective Form S-1 Registration Statement filed with the U.S. Securities and Exchange Commission raising approximately $2.50 million in net proceeds.

 

Conference Call and Webcast Details:

 

Date:                                                                      Friday, August 9, 2013

Time:                                                                      11:00 a.m. Eastern Time

 

Conference Call Dial-in Numbers                    

Participants from US Domestic:                       1 877 317-6776

Participants from International:                        1 412 317-6776

Conference ID:                                                     10032411

Webcast link:                                                        http://webcast.mzvaluemonitor.com/Cover.aspx?PlatformId=1545

 

Replay of the conference call will be available for one week following 1 hour after the end of the conference call through August 16, 2013 at 11:00 am ET.

 

Teleconference Replay Details:

 

US Domestic:                                                       1-877-344-7529

International:                                                        1-412-317-0088

Conference ID:                                                     10032411

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.

To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Safe harbor statement

Statements pertaining to anticipated developments, expected changes in R&D expenses, progress of research and development, potential sales growth, new products and distribution channels 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 and the management of collaborations, 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

(A Development Stage Company)

Condensed Consolidated Balance Sheets

(in thousands, except share data)

(Unaudited)

 

 

 

 

 

June 30,
2013

 

December 31,
2012

 

Assets

 

 

Cash and cash equivalents.............................................................................................................................

$           654

$                654

Accounts receivable, net of allowance for doubtful accounts of $26 and $4 at June 30, 2013 and December 31, 2012, respectively.............................................................................................................

             454

                  273

Inventory, net....................................................................................................................................................

          1,370

               1,199

Prepaid expenses and other current assets...................................................................................................

             663

                  456

Restricted cash..................................................................................................................................................

               50

                   —  

 

 

 

Total current assets................................................................................................................................

          3,191

               2,582

Property and equipment, net..........................................................................................................................

             928

               1,134

Intangible assets, net........................................................................................................................................

          1,947

               1,634

Deposits and other assets................................................................................................................................

               32

                    20

 

 

 

Total assets.............................................................................................................................................

$       6,098

$            5,370

 

 

 

Liabilities, Redeemable Preferred Stock and Stockholders’ Equity (Deficit)

 

 

Accounts payable.............................................................................................................................................

$           743

$                969

Accrued liabilities..............................................................................................................................................

          1,389

                  730

Deferred revenue..............................................................................................................................................

             172

                  233

Related party payable.....................................................................................................................................

               22

                       5

Advances...........................................................................................................................................................

             250

                  250

 

 

 

Total current liabilities...........................................................................................................................

          2,576

               2,187

 

 

 

Convertible Redeemable Series G Preferred stock, $0.001 par value, 5,000,000 shares were authorized, issued and outstanding at June 30, 2013 and December 31, 2012, liquidation preferences of $5,000 at June 30, 2013 and December 31, 2012........................................................................................................

          4,941

               4,941

 

 

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ Equity (Deficit)

 

 

Series D Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and outstanding at June 30, 2013 and December 31, 2012, liquidation preferences of $4,320 at June 30, 2013 and December 31, 2012...............................................................................................................................................

              —  

                   —  

Series B Preferred stock, $0.001 par value, 5,000,000 shares authorized, 300,000 issued and outstanding at June 30, 2013 and December 31, 2012, liquidation preferences of $393 and $385 at June 30, 2013 and December 31, 2012, respectively......................................................................................

              —  

                   —  

Series C Preferred stock, $0.001 par value, 3,000,000 shares authorized, 0 and 2,000,000 issued and outstanding at June 30, 2013 and December 31, 2012, respectively, liquidation preferences of $0 and $2,507 at June 30, 2013 and December 31, 2012, respectively...........................................................

              —  

                       2

Common stock, $0.001 par value, 300,000,000 shares authorized, 112,590,815 and 87,388,815 issued and outstanding at June 30, 2013 and December 31, 2012, respectively...................................................

             113

                    87

Additional paid-in capital..........................................................................................................................................

       74,173

            69,945

Deficit accumulated during the development stage...................................................................................

      (75,705 )

           (71,792 )

 

 

 

Total stockholders’ equity (deficit)...............................................................................................................

        (1,419 )

             (1,758 )

 

 

 

Total liabilities, redeemable preferred stock and stockholders’ equity (deficit)....................................

$       6,098

$            5,370

 

 

 

International Stem Cell Corporation and Subsidiaries

(A Development Stage Company)

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

Inception
(August 17,
2001)
through
June 30,

 

2013

 

2012

 

2013

 

2012

 

2013

 

Revenues

 

 

 

 

 

Product sales             

$  1,457

$  1,056

$  2,742

$  2,133

$ 14,940

Royalties and license              

        —  

        —  

        —  

        —  

         135

 

 

 

 

 

 

Total revenue 

    1,457

    1,056

    2,742

    2,133

    15,075

 

 

 

 

 

 

Development expenses

 

 

 

 

 

Cost of sales             

        329

        313

        663

        637

      5,269

Research and development   

        974

        865

    1,695

    1,802

    23,588

Marketing  

        679

        548

    1,191

    1,044

      7,130

General and administrative   

    1,667

    1,755

    3,099

    3,794

    42,227

 

 

 

 

 

 

Total development expenses     

    3,649

    3,481

    6,648

    7,277

    78,214

 

 

 

 

 

 

Loss from development activities 

   (2,192 )

   (2,425 )

   (3,906 )

   (5,144 )

  (63,139 )

 

 

 

 

 

 

Other income (expense)

 

 

 

 

 

Settlement with related company         

        —  

        —  

        —  

        —  

          (93 )

Miscellaneous expense           

         (18 )

         (56 )

         (20 )

         (54 )

        (265 )

Dividend income      

        —  

        —  

        —  

        —  

            94

Interest expense       

        —  

        —  

        —  

        —  

     (2,225 )

Sublease income      

          10

            4

          13

            7

         329

Change in market value of warrants   

        —  

        —  

        —  

          38

     (1,357 )

 

 

 

 

 

 

Total other income (expense), net             

           (8 )

         (52 )

          (7)

           (9 )              

     (3,517 )

 

 

 

 

 

 

Loss before income taxes

   (2,200 )

   (2,477 )

   (3,913 )

   (5,153 )

  (66,656 )

Provision for income taxes               

        —  

        —  

        —  

        —  

              7

 

 

 

 

 

 

Net loss 

$ (2,200 )

$ (2,477 )

$ (3,913 )

$ (5,153 )

$ (66,663 )

 

 

 

 

 

 

Deemed dividend on preferred stock              

        —  

        —  

        —  

   (1,375 )              

     (1,375 )

Dividends on preferred stock           

        —  

      (139 )

        —  

      (222 )

     (8,097 )

 

 

 

 

 

 

Net loss attributable to common stockholders             

$ (2,200 )

$ (2,616 )

$ (3,913 )

$ (6,750 )

$ (76,135 )

 

 

 

 

 

 

Net loss per common share-basic and diluted            

$   (0.02 )

$   (0.03 )

$   (0.04 )

$   (0.08 )

 

 

 

 

 

 

 

Weighted average shares-basic and diluted               

112,410

  87,106

108,013

  84,446

 

 

 

 

 

 

 

 

 

 

 

 

Contacts:

International Stem Cell Corporation

Dr. Simon Craw, Executive Vice President of Business Development

Phone: 760-940-6383

Email: ir@intlstemcell.com

 

Investor Relations:

MZ Group

Mark McPartland

Senior Vice President

Phone: 212-301-7130

Email: markmcp@mzgroup.us

Web: www.mzgroup.us