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): May 11, 2015
IMMUNOCELLULAR THERAPEUTICS, LTD.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Delaware |
|
001-35560 |
|
93-1301885 |
(State or other jurisdiction
of incorporation or organization) |
|
(Commission
File Number) |
|
(I.R.S. Employer Identification No.) |
23622 Calabasas Road
Suite 300
Calabasas,
California 91302
(Address of Principal Executive Offices) (Zip Code)
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):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
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 May 11, 2015, ImmunoCellular
Therapeutics, Ltd. (the Company) issued a press release announcing financial results for the quarter ended March 31, 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. |
|
|
|
Exhibit |
|
Description |
|
|
99.1 |
|
Press Release, dated May 11, 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.
|
|
|
|
|
Date: May 11, 2015 |
|
IMMUNOCELLULAR THERAPEUTICS, LTD. |
|
|
|
|
|
By: |
|
/s/ Andrew Gengos |
|
|
|
|
Andrew Gengos |
|
|
|
|
President and Chief Executive Officer |
EXHIBIT INDEX
|
|
|
Exhibit |
|
Description |
|
|
99.1 |
|
Press Release, dated May 11, 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 First Quarter 2015 Financial Results
Phase 3 Registration Trial for ICT-107 to Initiate in Second Half of
2015;
Financial Results Conference Call to be Held on May 12, 2015
Los Angeles, CA May 11, 2015 ImmunoCellular Therapeutics, Ltd. (ImmunoCellular) (NYSE MKT: IMUC) today announced financial
results for the first quarter 2015.
During the first quarter, we strengthened our Companys financial standing, advanced
ICT-107 toward our goal of initiating the phase 3 registration trial in newly diagnosed glioblastoma, continued to enroll patients in our ICT-121 phase 1 trial in recurrent glioblastoma, and moved forward with our novel Stem-to-T-cell program,
said Andrew Gengos, ImmunoCellulars Chief Executive Officer. We believe that we are on track to initiate the ICT-107 phase 3 trial in the late third quarter or fourth quarter of this year, following completion of the special protocol
assessment process with the FDA and finalization of agreements with cancer cooperative groups and our contract research organization, which will manage the trial. Our ICT-121 phase 1 program is actively enrolling patients, and we are making good
progress in starting our Stem-cell immunotherapy program which has potential advantages compared to engineered T-cell approaches to targeting and killing tumors. We believe that there is significant value in ImmunoCellular, given the breadth of our
platforms and our preclinical and clinical assets, led by ICT-107. We are committed to advancing our programs with the goal of unlocking that value, and building a leading cancer immunotherapy company.
For the quarter ended March 31, 2015, the Company reported a net loss of $1.4 million, or $0.02 per basic and diluted share, compared to
a net loss of $3.2 million, or $0.05 per basic and diluted share for the quarter ended March 31, 2014. During the quarter ended March 31, 2015, the Company incurred $2.0 million in research and development expenses compared to $1.7 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 ICT-121 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. Additionally, for the quarter ended March 31, 2015, the Company recognized a credit of $1.8 million related to the change in fair value of its warrant derivatives compared to a
charge of approximately $400,000 during the same period in 2014.
The Company reported that cash used in operations during the first
quarter of 2015 was $3.0 million compared to $2.6 million during the first quarter of 2014. The increase in cash used in operations primarily reflects additional research and development expenses. 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.
During the quarter ended March 31, 2015, the Company raised $14.5 million from the issuance of 26,650,000 shares of common stock and
warrants to purchase 18,655,000 shares. The warrants have a term of five years and an exercise price of $0.66. As of March 31, 2015, the Company had $34.8 million in cash.
Conference Call and Webcast to be Held May 12, 2015
ImmunoCellular plans to hold a conference call and webcast on Tuesday, March 12 at 5:00 pm ET to discuss the first quarter 2015 financial results and
business update. The call will be hosted by Andrew Gengos, President and CEO.
|
|
|
|
|
LIVE CALL: |
|
|
|
(877) 853-5636 (toll-free); international dial-in: (631) 291-4544; conference code 30452546. |
|
|
|
WEBCAST: |
|
|
|
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 in ICT-107, the advancement of the ICT-121 phase 1 trial and the development of our preclinical Stem-to-T-cell program. 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.
Condensed Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
3/31/2015 |
|
|
12/31/2014 * |
|
|
|
(unaudited) |
|
|
|
|
Cash |
|
$ |
34,771,179 |
|
|
$ |
23,222,296 |
|
Other current assets |
|
|
1,610,391 |
|
|
|
1,219,873 |
|
Non current assets |
|
|
596,235 |
|
|
|
736,392 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
36,977,805 |
|
|
$ |
25,178,561 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
1,486,413 |
|
|
$ |
1,289,199 |
|
Warrant liabilities |
|
|
3,122,077 |
|
|
|
597,719 |
|
Shareholders equity |
|
|
32,369,315 |
|
|
|
23,291,643 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
36,977,805 |
|
|
$ |
25,178,561 |
|
|
|
|
|
|
|
|
|
|
* |
Derived from audited financial statements |
Condensed Consolidated Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Three months ended |
|
|
|
3/31/2015 |
|
|
3/31/2014 |
|
Revenue |
|
$ |
|
|
|
$ |
|
|
Research and development |
|
|
1,998,619 |
|
|
|
1,699,760 |
|
Stock based compensation |
|
|
205,829 |
|
|
|
184,102 |
|
General and administrative |
|
|
896,672 |
|
|
|
865,402 |
|
|
|
|
|
|
|
|
|
|
Loss before other expenses |
|
|
(3,101,120 |
) |
|
|
(2,749,264 |
) |
Interest income |
|
|
3,257 |
|
|
|
3,354 |
|
Financing expense |
|
|
(88,939 |
) |
|
|
|
|
Change in fair value of warrant liabilities |
|
|
1,761,956 |
|
|
|
(416,067 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,424,846 |
) |
|
$ |
(3,161,977 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted: |
|
$ |
(0.02 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
EOM Pharmaceutical (PK) (USOTC:IMUC)
Historical Stock Chart
From Mar 2024 to Apr 2024
EOM Pharmaceutical (PK) (USOTC:IMUC)
Historical Stock Chart
From Apr 2023 to Apr 2024