On August 12, 2015 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the second quarter ended June 30, 2015, which included the announcement of three new immuno-oncology clinical collaborations and a cash position of $129.0 million, inclusive of net proceeds from a public offering in April 2015 (Press release, Immune Design, AUG 12, 2015, View Source [SID:1234507218]).
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Corporate Update and Recent Highlights
On August 10, 2015, Immune Design reported it had entered into two clinical trial collaborations with Merck (NYSE:MRK) to evaluate two immuno-oncology investigational agents, G100 and LV305, each separately combined with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1therapy, in Phase 1 trials in patients with non-Hodgkin’s lymphoma (NHL) and melanoma, respectively.
Earlier today, Immune Design announced it had entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of Immune Design’s CMB305 prime-boost immuno-oncology investigational agent combined with the investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1), in a randomized Phase 2 trial in patients with soft tissue sarcoma.
In May 2015, Immune Design announced the presentation of positive clinical data from three immuno-oncology Phase 1 studies at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The three trials provide first-in-human clinical data with the company’s immuno-oncology agents that are designed to generate anti-tumor immunity, LV305 and G305 which target the tumor-associated antigen, NY-ESO-1 and are the two components of CMB305 and G100, which in contrast, is a potent toll-like receptor-4 (TLR4) agonist that is being administered intratumorally to activate local and systemic immunity.
In April 2015, Immune Design closed an underwritten public offering of 3,000,000 shares of common stock at a price of $26.50 per share. In May 2015, the company sold an additional 47,409 shares when the underwriters exercised a portion of their overallotment option. Immune Design received aggregate net proceeds of $75.4 million, after underwriting discounts and commissions and offering expenses totaling $5.4 million.
Financial Results and Guidance
Second Quarter
Immune Design ended the second quarter of 2015 with $129.0 million in cash and cash equivalents, compared to $75.4 million as of December 31, 2014.
Net loss and net loss per share for the second quarter of 2015 were $10.5 million and $0.54, respectively, compared to $6.1 million and $16.57, respectively, for the second quarter of 2014.
Revenue for the second quarter of 2015 was $1.8 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the second quarter of 2014 was $1.1 million and related primarily to license revenue associated with the company’s collaboration with MedImmune.
Research and development expenses for the second quarter of 2015 were $8.5 million, compared to $3.9 million for the second quarter of 2014. The $4.6 million increase was primarily attributable to contract manufacturing and clinical trials for LV305 and CMB305, as well as activities related to the company’s HSV-2 collaboration with Sanofi Pasteur. Expenses incurred under the collaboration are predominantly reimbursed by Sanofi Pasteur and reflected in revenue. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth in research and development headcount to support Immune Design’s advancing research and clinical pipeline. Research and development stock-based compensation (a non-cash expense), was $0.5 million for the current quarter compared to $0.1 million for the same quarter in 2014.
General and administrative expenses for the second quarter of 2015 were $3.8 million, compared to $1.9 million for the second quarter of 2014. The $1.9 million increase was primarily attributable to increases in personnel-related expenses, including stock based compensation, primarily related to an increase in administrative headcount to support the growth and expansion of the business. General and administrative expenses for stock-based compensation (a non-cash expense), was $1.3 million for the current quarter compared to $0.1 million for the same quarter in 2014.
Year-to-Date
Net operating cash used in operations through June 2015 was $21.7 million, which excludes the $75.4 million in net proceeds received from the company’s follow-on offering.
Net loss and net loss per share for the six months ended June 30, 2015 were $19.9 million and $1.10, respectively, compared to $14.3 million and $38.81, respectively, for the same period in 2014.
Revenue for the six months ended June 30, 2015 was $3.7 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the same period in 2014 was $1.1 million related primarily to Immune Design’s collaboration with MedImmune.
Total operating expenses for the six months ended June 30, 2015 were $23.6 million, compared to $11.3 million for the same period in 2014. The increase in the current period relates primarily to contract manufacturing and clinical trials for LV305 and CMB305, as well as activities related to the company’s HSV-2 collaboration with Sanofi Pasteur. Expenses incurred under the collaboration are predominantly reimbursed by Sanofi Pasteur and reflected in revenue. Additionally, there was an increase in personnel-related expenses, including stock based compensation, as a result of growth and expansion of the business following Immune Design’s initial public offering in July 2014, in professional service fees and legal fees to support operations as a public company and to defend ongoing litigation, and in facility and office costs.
Updated Financial Guidance
In consideration of the funds raised through Immune Design’s follow-on equity offering in April 2015 and investment in the company’s clinical development pipeline, revised 2015 financial guidance is as follows:
Anticipate ending fiscal 2015 with a cash and investments balance of at least $110.0 million.
Estimate net cash used in operating activities of $36.0 to $40.0 million for the year-ending December 31, 2015. This is an increase from beginning of the year guidance, which was an estimated range of $33.0 to $37.0 for net cash used in operating activities.