On May 2, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported financial results and a corporate update for the first quarter ended March 31, 2018 (Press release, Immune Design, MAY 2, 2018, View Source [SID1234525968]).

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"The plan to start patient enrollment by mid-year in our pivotal Phase 3 of CMB305 in synovial sarcoma is on track. Moreover, G100 is emerging as an exciting, active immunotherapeutic molecule with great potential," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "The continued progress in our programs increases our confidence in Immune Design’s strategies, differentiation and potential in an underserved immuno-oncology space."

Recent Highlights

CMB305: novel prime-boost targeting NY-ESO-1+ cancers

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The higher dose of CMB305 (4x the vector component compared to earlier clinical studies) was found to be safe by a data monitoring committee and cleared to move forward into the planned pivotal Phase 3 trial in frontline maintenance in synovial sarcoma patients.

G100: novel, synthetic TLR4 agonist for intratumoral therapy

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Updated data in follicular lymphoma patients show that a higher dose of G100 (20ug, 2x the dose studied in the ongoing randomized study with pembrolizumab) has increased activity, as defined by a two-fold increase in tumor infiltrating lymphocytes (TILs) pre- vs. post-G100 treatment.
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Immune Design is planning to interact with the FDA regarding next steps for development of G100.

Financial Results

First Quarter

Immune Design ended the first quarter of 2018 with $131.0 million in cash and cash equivalents, short-term investments, and other receivables compared to $144.2 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $16.4 million.

Net loss and net loss per share for the first quarter of 2018 were $13.3 million and $0.28, respectively, compared to 12.6 million and $0.50, respectively, for the first quarter of 2017.

Revenue for the first quarter of 2018 was $0.5 million and was primarily attributable to the Sanofi G103 HSV2 vaccine collaboration. Revenue for the first quarter of 2017 was $5.5 million and was primarily attributable to $5.2 million in collaboration revenue associated with the Sanofi G103 collaboration and $0.3 million in product sales to other third parties.

Research and development expenses for the first quarter of 2018 were $10.3 million, compared to $14.0 million for the same period in 2017. The $3.7 million decrease was primarily attributable to a decrease of $4.8 million in contract manufacturing costs related both internal and collaboration programs. Offsetting this decrease was an increase of $1.1 million in personnel-related and other research and development expenses.

General and administrative expenses for the first quarter of 2018 were $4.0 million, relatively consistent with general and administrative expenses of $4.1 million recorded in the first quarter of 2017.

Cash Guidance

Based on current expectations, Immune Design expects to have cash to fund operations into the second half of 2020.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss first quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code 1088768.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.