UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT
REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 10, 2015
IMMUNOCELLULAR THERAPEUTICS, LTD.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-35560 |
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93-1301885 |
(State or other jurisdiction of
incorporation or organization) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
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23622 Calabasas Road
Suite 300
Calabasas, California 91302 |
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(Address of Principal Executive
Offices) (Zip Code) |
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Registrants telephone number, including area code: (818) 264-2300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On November 10, 2015, ImmunoCellular Therapeutics, Ltd. (the Company) issued a press release announcing financial results for
the quarter ended September 30, 2015. A copy of this press release is attached as Exhibit 99.1.
This information, including exhibits
attached hereto and the information under item 9.01 below, shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the
liabilities of that section. This information shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01. Financial Statements and Exhibits.
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(d) |
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Exhibits. |
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Exhibit |
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Description |
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99.1 |
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Press Release, dated November 10, 2015 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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Date: November 10, 2015 |
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IMMUNOCELLULAR THERAPEUTICS, LTD. |
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By: |
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/s/ Andrew Gengos |
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Andrew Gengos |
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President and Chief Executive Officer |
EXHIBIT INDEX
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Exhibit |
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Description |
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99.1 |
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Press Release, dated November 10, 2015 |
Exhibit 99.1
Contact:
ImmunoCellular
Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
ImmunoCellular
Therapeutics Announces Third Quarter 2015 Financial Results
ICT-107 Phase 3 Registration Trial Expected to be Initiated in
November
Los Angeles, CA November 10, 2015 ImmunoCellular Therapeutics, Ltd. (ImmunoCellular) (NYSE MKT: IMUC)
today announced financial results for the third quarter 2015.
Andrew Gengos, ImmunoCellular Chief Executive Officer, commented:
With the many milestones we achieved in the third quarter, and throughout this year, we believe that we have changed the trajectory and reshaped the future of ImmunoCellular, and made significant advances toward our goal of becoming a leading
cancer immunotherapy company. The highlights of the quarter include reaching agreement with the FDA on the Special Protocol Assessment for the ICT-107 registrational trial in patients with newly diagnosed glioblastoma, and receiving the almost $20
million award from the California Institute for Regenerative Medicine (CIRM) to support the program. We are on the cusp of achieving a major milestone with the start of our Companys first registrational phase 3 program, anticipated to be
initiated this month. We also look forward to presenting updated ICT-107 phase 2 trial results at the Society for Neuro-Oncology (SNO) meeting on November 20th. We remain on track to achieve
our goals this year, underscoring our confidence that 2015 is a year of meaningful growth, transition and value creation for our company.
For the
quarter ended September 30, 2015, the Company reported a net loss of $3.4 million, or $0.04 per basic and diluted share, compared to a net loss of $1.9 million, or $0.03 per basic and diluted share for the quarter ended September 30, 2014.
During the quarter ended September 30, 2015, the Company incurred $2.6 million in research and development expenses compared to $1.5 million in the same quarter of 2014. The increase reflects costs related to the ramp-up of the phase 3 trial of
ICT-107, patient enrollment in the ICT-121 phase 1 trial and ramp-up of expenses related to the Companys Stem-to-T-cell program. These expenses were partially offset by reductions in the ICT-107 phase 2 trial, which continued to wind down, and
suspension of the Companys ICT-140 ovarian cancer program.
For the nine months ended September 30, 2015, the Company reported a net loss of $8.0 million, or $0.09 per
basic and diluted share, compared to $7.3 million, or $0.12 per basic and diluted share during the same period in 2014. During the nine months ended September 30, 2015, the Company incurred additional research and development expenses. Also,
during the nine months ended September 30, 2015, the Company recorded a gain of $2.3 million related to a reduction in the valuation of its derivative warrants compared to a gain of $400,000 in the same period of 2014.
The Company reported that cash used in operations during the nine months ended September 30, 2015 was $13.2 million compared to $7.8 million during the
same period of 2014. The increase in cash used in operations primarily reflects additional research and development expenses and also reflects $4.0 million of vendor deposits related to the ICT-107 Phase 3 trial. These deposits will be offset
against future amounts owed to these vendors. Other expenses were consistent between periods. The Company expects that research and development expenses will continue to increase in future periods as it prepares for the phase 3 trial of ICT-107 and
as it expands its Stem-to-T-cell program.
On September 18, 2015 the Company received an award in the amount of $19.9 million from CIRM to partially
fund the Companys phase 3 trial of ICT-107. Under the terms of the CIRM award, the Company is obligated to share future ICT-107 related revenue with CIRM. Alternatively, the Company may convert the award to a loan. Since the Company may be
required to repay some or all of the amounts awarded by CIRM, the Company plans to account for this award as a liability rather than as revenue.
As of
September 30, 2015, the Company had $24.4 million in cash and cash equivalents.
Conference Call and Webcast Today
ImmunoCellular plans to hold a conference call and webcast today at 5:00 pm ET to discuss the third quarter 2015 financial results and business update. The
call will be hosted by Andrew Gengos, President and CEO.
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LIVE CALL: |
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(877) 853-5636 (toll-free); international dial-in: (631) 291-4544; conference code 65076933. |
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WEBCAST: |
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Interested parties who wish to listen to the webcast should visit the Investor Relations section of ImmunoCellulars website at www.imuc.com, under the Events and Presentations tab. A replay of the webcast will be
available one hour after the conclusion of the event. |
The conference call will contain forward-looking statements. The information provided on the teleconference is accurate only
at the time of the conference call, and ImmunoCellular will take no responsibility for providing updated information except as required by law.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other
cancers. ImmunoCellular has concluded a phase 2 trial of its lead product candidate, ICT-107, a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. ImmunoCellulars pipeline also includes:
ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen on stem cells in recurrent glioblastoma; ICT-140, a dendritic cell immunotherapy targeting antigens on ovarian cancer stem cells; and the Stem-to-T-cell research program which
engineers the patients hematopoietic stem cells to generate antigen-specific cancer-killing T-cells.
Forward-Looking Statements for
ImmunoCellular Therapeutics
This press release contains certain forward-looking statements, including statements regarding the development and
commercialization of ICT-107, initiation of a phase 3 study of ICT-107, the advancement of the ICT-121 phase 1 trial, the development of our preclinical Stem-to-T-cell program and our ability to achieve our other clinical, operational and financial
goals. These statements are based on ImmunoCellulars current expectations and involve significant risks and uncertainties, including those described under the heading Risk Factors in ImmunoCellulars most recently filed
quarterly report on Form 10-Q and annual report on Form 10-K. Except as required by law, ImmunoCellular undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Consolidated Condensed Balance Sheets |
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9/30/2015 |
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12/31/2014 |
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(Unaudited) |
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Cash |
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$ |
24,435,152 |
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$ |
23,222,296 |
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Other current assets |
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1,328,955 |
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1,219,873 |
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Non current assets |
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5,086,334 |
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736,392 |
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Total assets |
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$ |
30,850,441 |
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$ |
25,178,561 |
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Current liabilities |
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$ |
2,004,932 |
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$ |
1,289,199 |
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Warrant liability |
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2,555,735 |
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597,719 |
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Shareholders equity |
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26,289,774 |
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23,291,643 |
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$ |
30,850,441 |
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$ |
25,178,561 |
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Consolidated Condensed Statements of Operations (Unaudited) |
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3 months
ended 9/30/2015 |
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3 months ended 9/30/2014 |
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9 months
ended 9/30/2015 |
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9 months ended 9/30/2014 |
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Revenue |
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$0 |
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$0 |
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$0 |
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$0 |
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Research and development |
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2,592,255 |
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1,486,352 |
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6,827,691 |
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4,646,156 |
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Stock based compensation |
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245,559 |
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170,805 |
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675,523 |
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483,455 |
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General and administrative |
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908,075 |
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786,688 |
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2,731,384 |
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2,490,322 |
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Loss before other expenses |
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(3,745,889) |
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(2,443,845) |
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(10,234,598) |
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(7,619,933) |
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Interest income |
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5,498 |
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4,207 |
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14,408 |
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10,711 |
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Financing expense |
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0 |
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(9,478) |
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(88,939) |
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(34,078) |
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Change in fair value of warrant liability |
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339,136 |
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559,873 |
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2,328,298 |
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392,940 |
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Net loss |
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($3,401,255) |
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($1,889,243) |
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($7,980,831) |
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($7,250,360) |
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Net loss per share, basic and diluted: |
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$ |
(0.04) |
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$ |
(0.03) |
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$ |
(0.09) |
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$ |
(0.12) |
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Consolidated Condensed Balance Sheets |
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9/30/2015 |
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12/31/2014 |
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(Unaudited) |
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Cash |
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$ |
24,435,152 |
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$ |
23,222,296 |
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Other current assets |
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1,328,955 |
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1,219,873 |
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Non current assets |
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5,086,334 |
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736,392 |
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Total assets |
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$ |
30,850,441 |
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$ |
25,178,561 |
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Current liabilities |
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$ |
2,004,932 |
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$ |
1,289,199 |
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Warrant liability |
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2,555,735 |
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597,719 |
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Shareholders equity |
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26,289,774 |
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23,291,643 |
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$ |
30,850,441 |
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$ |
25,178,561 |
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Consolidated Condensed Statement of Operations (Unaudited) |
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3 months
ended 9/30/2015 |
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3 months ended 9/30/2014 |
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9 months
ended 9/30/2015 |
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9 months ended 9/30/2014 |
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Revenue |
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$0 |
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$0 |
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$0 |
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$0 |
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Research and development |
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2,592,255 |
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1,486,352 |
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6,827,691 |
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4,646,156 |
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Stock based compensation |
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245,559 |
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170,805 |
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675,523 |
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483,455 |
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General and administrative |
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|
908,075 |
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786,688 |
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2,731,384 |
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2,490,322 |
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Loss before other expenses |
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(3,745,889) |
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(2,443,845) |
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(10,234,598) |
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(7,619,933) |
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Interest income |
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5,498 |
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4,207 |
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14,408 |
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10,711 |
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Financing expense |
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0 |
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(9,478) |
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(88,939) |
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(34,078) |
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Change in fair value of warrant liability |
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339,136 |
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559,873 |
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2,328,298 |
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392,940 |
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Net loss |
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($3,401,255) |
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($1,889,243) |
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($7,980,831) |
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($7,250,360) |
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Net loss per share, basic and diluted: |
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$ |
(0.04) |
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$ |
(0.03) |
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$ |
(0.09) |
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$ |
(0.12) |
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