Immune Design Corp. (IMDZ - Free Report) reported loss of 29 cents per share in second-quarter 2018, narrower than the Zacks Consensus Estimate of a loss of 30 cents and the year-ago loss of 54 cents.
Immune Design’s shares have lost 8.9% year to date compared with the industry’s decline of 1.2%.
Quarter in Detail
Total revenues were $0.76 million, up from $0.73 million in the year-ago quarter. Revenues were mainly received from the collaboration with Sanofi (SNY - Free Report) for G103 (HSV2 therapeutic cancer), along with product sales to collaboration partners. Quarterly revenues beat the Zacks Consensus Estimate of $0.64 million.
Research and development (R&D) expenses increased 1.3% to $11 million in the quarter. The surge was due to an increase in personnel-related expenses and a rise in research and development headcount to support the company’s advancing research and clinical pipeline activities.
General and administrative expenses rose 3% to $4 million.
Immune Design is developing multiple candidates using its discovery platforms — ZVex and GLAAS — in the field of immuno-oncology. Its key pipeline candidates include G100 and CMB305.
Following the end of its phase I Type B meeting with the FDA, regarding a development path for G100, the FDA provided guidance in relapsed refractory follicular lymphoma patients. The FDA stated that a single-arm open label study, using overall response rate and duration of responses as endpoints, is appropriate to assess the efficacy of G100 in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab), in a population with relapsed refractory follicular lymphoma.
The FDA also agreed on an adaptive design study for those patients who have failed three or more lines of systemic therapy that allows for an interim analysis. This will determine the final study design including line-of-therapy and study size. The company intends to use this open label study approach to generate data for a potential biological license application. It is working with the FDA to finalize the details of the protocol.
The company has started enrollment in the phase III SYNOVATE study, evaluating CMB305 monotherapy versus placebo in synovial sarcoma patients in a post first-line therapy maintenance setting.
The phase II study, evaluating the combination of CMB305 with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) in relapsed refractory soft-tissue sarcoma patients, continues follow-up to determine overall survival after achieving an estimated 72 events. Top-line results from the study are expected in the first quarter of 2019.
Immune Design expects cash to fund operations into the second half of 2020.
Immune Design currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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