SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): June 21, 2017
IMMUNOCELLULAR THERAPEUTICS, LTD.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
of incorporation or organization)
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))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|Item 8.01.||Other Events.|
On June 21, 2017, ImmunoCellular Therapeutics, Ltd. issued a press release entitled ImmunoCellular Therapeutics Provides Update on Strategic Review and Decision to Suspend Further Patient Randomization for ICT-107 Phase 3 Trial, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Press Release, dated June 21, 2017.|
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: June 21, 2017||IMMUNOCELLULAR THERAPEUTICS, LTD.|
|By:||/s/ David Fractor|
|Chief Financial Officer|
|99.1||Press Release, dated June 21, 2017.|
ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics Provides Update on Strategic Review and Decision to
Suspend Further Patient Randomization for ICT-107 Phase 3 Trial
Los Angeles, CA June 21, 2017 ImmunoCellular Therapeutics, Ltd. (ImmunoCellular) (NYSE MKT: IMUC) today provided an update on the strategic review of its financing and development strategies for ICT-107, its patient-specific, dendritic cell-based immunotherapy for patients with newly diagnosed glioblastoma.
ImmunoCellular has determined that the Company is unable at this time to secure sufficient additional financial resources to complete the phase 3 registration trial of ICT-107. As a result, the Company intends to suspend further patient randomization in the ICT-107 trial while it continues to seek a collaborative arrangement or acquisition of its ICT-107 program. The Company plans to actively work with current collaborators to ensure that patients already randomized and receiving treatment in the phase 3 trial can be appropriately supported and followed. The suspension of the phase 3 registration trial of ICT-107 is expected to reduce the amount of cash used in the Companys operations.
While maintaining the focus on its Stem-to-T-Cell research programs, ImmunoCellular continues its evaluation of financing and strategic alternatives for its immuno-oncology research and development pipeline and technology platform, which may include a potential merger, consolidation, reorganization or other business combination, as well as the sale of the Company or the Companys assets.
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. ImmunoCellulars pipeline includes: a Stem-to-T-cell research program, which engineers hematopoietic stem cells to generate cytotoxic T cells; ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting CD133 found in recurrent glioblastoma; and ICT-140, a patient-specific, dendritic cell-based immunotherapy targeting ovarian cancer. ImmunoCellular recently suspended further patient randomization in its phase 3 trial of ICT-107 in HLA-A2 patients while it pursues a collaborative arrangement or acquisition of its ICT-107 program. To learn more about ImmunoCellular, please visit www.imuc.com .
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements, including statements regarding ImmunoCellulars intentions and current expectations concerning, among other things, whether ImmunoCellular will be able to enter into an agreement with a strategic partner, collaborator or acquirer of its ICT-107 program; ImmunoCellulars expectations regarding its ability to reduce the amount of cash used in the Companys operations; ImmunoCellulars ability to ensure that patients already randomized and receiving treatment in the phase 3 trial can be appropriately supported and followed; the likelihood, timing and outcome of ImmunoCellulars evaluation of financing and strategic alternatives; and ImmunoCellulars ability to achieve its other clinical, operational, strategic and financial goals. Forward-looking statements are not guarantees of future performance and are subject to a number of risks and uncertainties, including the availability of resources to continue to develop ImmunoCellulars product candidates, the uncertain timing of completion and success of clinical trials, and the risk that ICT-107 can be further successfully developed or commercialized. Additional risks and uncertainties are described under the heading Risk Factors in ImmunoCellulars most recently filed quarterly report on Form 10-Q for the period ended March 31, 2017. 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.