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): October 11, 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 7.01.||Regulation FD Disclosure.|
ImmunoCellular Therapeutics, Ltd. (the Company ) is furnishing the Investor Presentation, dated October 11, 2017, attached as Exhibit 99.1 to this Current Report on Form 8-K, which the Company may use from time to time in presentations to investors and other stakeholders.
The information in Item 7.01 of this Form 8-K (including Exhibit 99.1) shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered filed or incorporated by reference therein.
|Item 9.01.||Financial Statements and Exhibits.|
|99.1||Investor Presentation of ImmunoCellular Therapeutics, Ltd., dated October 11, 2017.|
|99.1||Investor Presentation of ImmunoCellular Therapeutics, Ltd., dated October 11, 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: October 11, 2017||IMMUNOCELLULAR THERAPEUTICS, LTD.|
/s/ David Fractor
|Chief Financial Officer|
NYSE American: IMUC.BC October 2017 Corporate Presentation Exhibit 99.1
Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our plans, timelines, prospects, objectives, expectations and intentions with respect to the potential for success of our potential products, cancer immunotherapy research, development efforts and timelines, regulatory status, business, operations, intellectual property, financial condition and other statements that are not historical in nature, are forward-looking statements. You should consider forward-looking statements carefully because they may include statements regarding our future expectations or projections about future events. These statements involve known and unknown risks, uncertainties, assumptions and other factors, including those described in our filings with the Securities and Exchange Commission (SEC). You are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements included in this presentation are made only as of the date of this presentation, and, except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
ImmunoCellular Therapeutics Developing treatments to stimulate the ability of the immune system to fight cancer Cancer immunotherapy we believe to be the wave of the future – TODAY Development-stage company committed to developing immunotherapeutic solutions for intractable cancers, extending the lives of cancer patients, and providing hope for a potential cure IMUC’s Stem-to-T-Cell program is a novel approach that enables the patient’s immune system to produce targeted killer T cells Multiple value driving milestones next expected in the 12-18 months Need for immunotherapy for cancer: Surgery may not remove every cancer cell Chemotherapy and radiation therapy may damage normal tissue Target all rapidly dividing cells leading to significant toxicity Cancer can recur after apparently successful treatment Cancer stem cells Goal of creating “plug & play” scenario – menu of solutions for patient’s specific tumor
Immunotherapy has several potential advantages over traditional approaches Harnesses the power of each patient’s immune system Tumor-specific Longer-lasting Advantageous safety profile IMUC focus on solid tumors Personalized Cancer Immunotherapy Potential to address severe unmet medical needs
Potential Advantages of Stem-to-T-Cell Approach Unlike CAR-T therapy, T cells will be “produced” by the treated HSCs that are reintroduced to the patient Slower production and subsequent release of targeted CD8+ T cells should be less toxic to the patient More measured killing can be cleaned up by the patient without triggering a cytokine release syndrome Because the treated HSCs will return to the bone marrow, we believe there should be a level of surveillance against recurrence of the tumor Autologous nature of the product we believe will prevent GVHD Careful selection of TCRs will ensure only the tumor is targeted Expect be able to address many tumor types
Three Clinical-Stage Programs ImmunoCellular actively looking to partner, sell or license all three programs Dendritic cell-based research: ICT-107 Phase 3 ready for glioblastoma ICT-121 Phase 1 completed for recurrent glioblastoma (warrants continued testing) ICT-140 Phase 1/2 ready for ovarian cancer ImmunoCellular has the advantage of two personalized immunotherapeutic approaches to drive T cell killing of cancer cells
ImmunoCellular Therapeutics Stem-to-T-Cell Program Early-stage research program, using IP from Dr. David Baltimore’s lab, a Nobel laureate of Caltech, testing effects of transfecting a selected T cell receptor into a patient’s hematopoietic stem cells These transfected HSCs would then be reintroduced to the patient and they would return to the bone marrow Goal is to develop a TCR library to allow a “plug and play” scenario where a patient’s specific tumor can be addressed Improve cancer treatment by stimulating patients’ immune systems to generate a long-term population of cytotoxic T cells directed against the tumor, resulting in a potentially curative therapy for many types of cancers
Hematopoietic Stem Cells Can produce all blood cell types and other stem cells Reside in bone marrow Can be mobilized into circulation with G-CSF Can be isolated and purified Can be genetically modified to produce target-specific killer T cells
Stem-to-T-Cell Program: Novel Technology In-Licensed from David Baltimore’s Lab at Caltech HSC CD8+ T Cell Tumor TCR Lentivirus Collect Blood from Patient Isolate Hematopoietic Stem Cells Package TCR DNA into Lentivirus Transfect Lentivirus w/TCR Gene into HSC Transfected HSC Isolate TCR Sequence TCR Expand Administer to Patient Packaged Lentivirus Cytotoxic T Cells
Collaborations University of Maryland, Baltimore (“UMB”) Sponsored research partner Conducting three preclinical research programs California Institute of Technology (“Caltech”) Stem-to-T-Cell preclinical technology licensed in 2014 MD Anderson Cancer Center For the discovery of novel T cell receptors
Milestones PROGRAM PARTNER TIMING Small molecule combinations with immunotherapy University of Maryland Q1-2018 Engineered T cell combinations with immunotherapy University of Maryland Q2-2018* Modified antigens for enhanced DC immunotherapy University of Maryland Q2-2018* Initiate preclinical in vivo experiments TBD Q2-2018* * Expected
Recent Financing July 2017 – Initially raised $5.0 million from sale of 5,000 shares of convertible preferred stock Issued warrants to purchase 9,000 shares of convertible preferred stock Potential additional gross proceeds of $9.0 million Warrants mature October 2017 January 2018 July 2018 Underwriter: Maxim Group, LLC Use of proceeds (i) reduce outstanding accounts payable and (ii) restructuring costs to transition to immune-oncology research program Warrants exercise will allow Company to execute its research and development projects
Financial Overview Stock price: $0.40 (as of 10/6/17) Shares outstanding: 15.8 million shares (as of 8/9/17) Market capitalization: $6.35 million (as of 10/6/17) Cash and cash equivalents: $1.8 million (as of 6/30/17) Excludes $5.0 million initial proceeds from July 2017 financing Average daily trading volume (3-months): 2.3 million shares Fiscal year-end: December 31 Financial Recap – six month period, as of June 30, 2017 Research and development expenses: $15.0 million Expect reduced R&D going forward General and administrative expense: $1.8 million Expect reduced G&A going forward “Out of the money” warrants outstanding: 1.6 million “Out of the money” stock options outstanding: 153,000
Management Anthony J. Gringeri, Ph.D. - President and Chief Executive Officer Appointed Chief Executive Officer in December 2016 25+ years of executive experience in the pharmaceutical and biotechnology industry Chief Operating Officer for Amsterdam Molecular Therapeutics Amgen for 15 years in a series of executive leadership roles Ph.D. in Pharmacology from the University of Rochester Steven J. Swanson, Ph.D. - Senior Vice President, Research 15 years at Amgen as Department Head for Clinical Immunology Led the immunoassay laboratory in the Biotechnology department at Schering Plough Research Institute Actively involved in the American Association of Pharmaceutical Scientists (AAPS), Ph.D. Microbiology from the University of Iowa David Fractor, CPA - Chief Financial Officer Appointed Chief Financial Officer April 2017; Previously, Treasurer and Vice President, Finance since April 2011; Since 2003 provided financial consulting and strategic planning services Chief Financial Officer of HemaCare Corporation from 1999 through 2003 Previously served as an audit manager at Deloitte and at a regional accounting firm B.S. in Accounting from the University of Southern California in 1982 Member of AICPA and the California Society of CPAs
Developing immunotherapeutic solutions for intractable cancers, extend the lives of cancer patients, and provide hope for a potential cure IMUC’s Stem-to-T-Cell approach is potentially “game changing” treatment for cancer Harnesses the patient’s immune system in manufacturing specific cytotoxic T cells to destroy cancer cells Provide long-term immuno-surveillance Immuno-oncology is fast evolving field Multiple approaches using immunotherapy being evaluated in clinical trials Potential for combination therapies Immunotherapy has the potential to change cancer treatment Specificity in targeting tumor cells Enhanced patient safety compared to current standard of care Opportunities for partnering with pharma and big biotech seeking novel cancer immunotherapy assets IMUC represents opportunity for value creation for investors today. Summary
NYSE American: IMUC.BC October 2017 Corporate Presentation