On August 22, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the second quarter of 2016 (Filing, Q2, ImmunoCellular Therapeutics, 2016, AUG 22, 2016, View Source [SID:1234514672]).
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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We are pleased with the progress we made in the first half of this year, and believe that 2016 will be a year of accomplishment for our company. The first patient in the ICT-107 phase 3 trial was treated in June – a major achievement for our company. Today, more than 140 patients have been screened and clinical site activation is accelerating. We currently have activated 60 clinical sites in the US, two in Canada, and one in the UK, with more expected to come in the third quarter. With ICT-107, ImmunoCellular is one of a small number of companies in the cancer immunotherapy arena that we believe to be in the final stage of clinical development. In light of these achievements, our confidence remains high for the value and quality of our phase 3 program, and the therapeutic and commercial potential of ICT-107. The phase 1 open-label trial of ICT-121 in patients with recurrent glioblastoma has completed enrollment, reaching the target of 20 patients. The trial is being conducted at six sites in the US and preliminary results are expected in about 9 months. We are grateful for the continued support of the medical and scientific cancer community, and the confidence placed in our company by our collaborators."
Upcoming Goals and Milestones:
• ICT-107:
• Continue to bring US, Canadian and European clinical sites online, with the goal of having all sites in all 10 countries activated by the end of 2016.
• Anticipate randomization of all patients by the end of 2017, and an additional 2-3 years from then to achieve the at least 274 required events.
• Plan to conduct a futility interim analysis at 30% of events, or at about the 2-year mark, and an efficacy interim analysis at 67% of events, or at about the 2 1⁄2 -year mark.
• Present updated immune monitoring data from the ICT-107 phase 2 trial and updated long-term survival data from the phase 1 trial at the Society for NeuroOncology annual scientific meeting in November 2016 in two oral presentations.
• ICT-121:
• Continuing to monitor patients, with data expected in about 9 months.
• Research:
• Anticipate having one or more T cell receptors identified for a Stem-to-T-cell clinical candidate or candidates by year-end 2016.
• Initial attempt to package a T cell receptor DNA sequence in the lentivirus/gene therapy construct by year-end 2016.
• Continued progress in collaboration with University of Maryland on projects that have application to existing dendritic cell immunotherapy and Stem-to-T-cell technology platforms.
Second Quarter 2016 Financial Results
For the quarter ended June 30, 2016, ImmunoCellular incurred a net loss of $5.3 million, or $0.06 per basic and diluted share, compared to a net loss of $3.2 million, or $0.03 per basic and diluted share, for the quarter ended June 30, 2015.
During the second quarter 2016, ImmunoCellular incurred $4.4 million of research and development expenses compared to $2.3 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.1 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107.
For the six months ended June 30, 2016, ImmunoCellular incurred a net loss of $11.0 million, or $0.12 per basic and diluted share, compared to a net loss of $4.6 million, or $0.05 per basic and diluted share, During the six months ended June 30, 2016, ImmunoCellular incurred $9.2 million in research and development expenses compared to $4.4 million in the prior year.
ImmunoCellular also reported that cash used in operations during the six months ended June 30, 2016 was $11.2 million compared to $6.9 million in the prior year. The increase primarily reflects that additional research and development expenditures in the current year. As of June 30, 2016, ImmunoCellular had $11.9 million in cash.
Subsequent to June 30, 2016, ImmunoCellular entered into an underwriting agreement with Maxim Group LLC, pursuant to which it sold 34,550,000 shares of common stock, pre-funded warrants to purchase 12,450,000 shares of ImmunoCellular’s common stock and base warrants to purchase 35,250,000 shares of its common stock. The common stock and base warrants were sold at a combined public offering price of $0.16, and the base warrants were approved for listing on the NYSE MKT under the symbol "IMUC.WS." The pre-funded warrants were sold to certain investors in lieu of common stock less the $0.01 per share exercise price for each pre-funded
warrant. The base warrants have an exercise price of $0.1921 per share. Additionally, ImmunoCellular granted the underwriters a 45 day option to purchase up to an additional 7,050,000 shares of common stock and/or base warrants to purchase 5,287,000 shares of its common stock. On August 12, 2016, the underwriters exercised the option to purchase 4,478,625 of additional base warrants at a price of $0.01266 per base warrant. The gross proceeds from the offering are approximately $7.5 million.
Additionally, the terms of the California Institute of Regenerative Medicine (CIRM) award were modified such that ImmunoCellular received an additional $1.5 million in July 2016 as part of the initial award received from CIRM. The total amount of the award and other award conditions remain unchanged.