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)

Registrant’s 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.

 

(d) 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

 

LOGO

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 Company’s 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, ImmunoCellular’s 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 Company’s 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 Company’s 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 ImmunoCellular’s 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. ImmunoCellular’s 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 patient’s 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 ImmunoCellular’s current expectations and involve significant risks and uncertainties, including those described under the heading “Risk Factors” in ImmunoCellular’s 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 Click Here for more EOM Pharmaceutical (PK) Charts.
EOM Pharmaceutical (PK) (USOTC:IMUC)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more EOM Pharmaceutical (PK) Charts.