On March 7, 2017 (GLOBE NEWSWIRE) — Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the fourth quarter and full year ended December 31, 2016 (Press release, Immune Design, MAR 7, 2017, View Source [SID1234518036]). Schedule your 30 min Free 1stOncology Demo! "Throughout 2016, we continued enrollment of our key clinical programs, recruited senior leadership with late-stage oncology drug development expertise, and further evolved our ZVex platform to potentially enable a wider range of differentiated products. In addition, we successfully closed a follow-on offering that brought in new investors, as well as additional support from some key existing investors," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "We look forward to a year in which clinical data begin to validate Immune Design’s approaches to treating patients."
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2016 Highlights and Corporate Update
Product Development: Progress on all programs and targeting data releases throughout 2017
Antigen Specific: CMB305 Program and ZVexMulti Next-Generation Product Candidates
CMB305 is the prime-boost approach targeting NY-ESO-1-expressing tumors to generate anti-NY-ESO-1 T cells in vivo via a mechanism of action Immune Design believes differs from traditional cancer vaccines. CMB305 is being evaluated in soft tissue sarcoma (STS) patients in ongoing Phase 1 and 2 monotherapy and combination studies with the anti-PD-L1 antibody, atezolizumab.
CMB305 monotherapy
Follow-up of 48 STS patients from two fully enrolled monotherapy Phase 1 trials continues (CMB305; n=25 patients, and its vector-only component, LV305; n=23 patients). As of December 31, 2016:
The safety profile remains favorable, with a consistent rate of NY-ESO-1-triggered T cell responses that appear stronger with CMB305.
The median overall survival (OS) has still not been reached in either the CMB305 or LV305 study.
Given that chemotherapeutic agents approved to treat second line metastatic STS have shown a median OS of 12.4-13.5 months, Immune Design believes this survival trend and favorable safety profile seen to date warrants evaluating further development of CMB305 as a monotherapy in recurrent STS patients.
CMB305 in combination with TECENTRIQ (atezolizumab)
Enrollment continues in this randomized 80 patient, Phase 2 study in which patients receive CMB305 plus atezolizumab vs. atezolizumab alone, pursuant to a collaboration with Genentech.
In addition to the potential of CMB305 as a monotherapy, the combination of CMB305 with a checkpoint inhibitor offers an additional potential approval path.
2017 Presentation Planning
Immune Design submitted data for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2017 (ASCO 2017) from the CMB305 monotherapy trial in STS patients.
Immune Design intends to submit data from the first 36 patients in the study combining CMB305 with atezolizumab for presentation at the European Society for Medical Oncology 2017 Congress in September 2017.
ZVexMulti, the evolution of the ZVex platform designed to deliver multiple, full length antigens and immunomodulatory molecules, continues to progress in preclinical development.
ZVexMulti is engineered to avoid potential antigenic competition and enable the delivery of multiple RNA genes selectively to dendritic cells to induce a simultaneous and balanced T cell response against all antigens.
Immune Design believes this is a potentially significant advancement in its product development capabilities, enabling the development of therapies with the potential to target a wide range of conserved antigens and large number of neo-epitopes. ZVexMulti should allow for the expression of a much larger number of epitopes than achievable with other platforms, obviating the need for a proprietary predictive algorithm to derive a limited set of epitopes.
Antigen Agnostic: G100 Program
G100, consisting of a synthetic, formulated TLR4 agonist injected intratumorally, continues to be evaluated in an ongoing randomized Phase 1/2 trial in patients with follicular non-Hodgkin lymphoma (fNHL) as both a monotherapy and combination therapy.
In the monotherapy portion, patients receive either G100 and low-dose radiation (RadRx) or G100 and low-dose RadRx with the systemic administration of the anti-PD-1 antibody, Keytruda (pembrolizumab), pursuant to a collaboration with Merck.
In contrast with CMB305’s focus on OS, the initial endpoint focus for this study is on response rates in both treated and distal, non-treated lesions (abscopal effect).
Immune Design submitted data from the G100 monotherapy portion of the study for presentation at ASCO (Free ASCO Whitepaper) 2017 and intends to submit data from the first 24 patients in the randomized part of the study of G100 with or without pembrolizumab for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting to be held in December.
Expansion of Board of Directors and Senior Leadership Team
Dr. Susan L. Kelley joined the Immune Design Board in June 2016, and brings more than 25 years’ experience in oncology and immunology drug development to the company.
Dr. Sergey Yurasov joined the Immune Design team as Senior Vice President of Clinical Development and Chief Medical Officer in October 2016. Dr. Yurasov brings more than 20 years’ experience in immunology and late-stage oncology drug development to the company.
Acquisition of Intellectual Property Rights and Settlement of Litigation and Patent Challenge
In October 2016, Immune Design announced the acquisition of intellectual property rights from, and settlement of outstanding legal proceedings with, Theravectys SA (TVS). Immune Design obtained a license to certain present and future intellectual property of TVS related to the company’s ZVex platform and resolved all outstanding proceedings in Delaware and Belgium and a patent opposition proceeding brought by TVS against one of the company’s patents related to ZVex. Please refer to Immune Design’s Current Report on Form 8-K filed on October 21, 2016 for a more complete description of the terms.
Completion of Follow-On Financing
In September 2016, Immune Design completed an underwritten follow-on public offering, which resulted in the sale of 5,226,369 shares of common stock, at a price of $6.25 per share. Net proceeds from the offering were $30.3 million after deducting underwriting discounts, commissions and estimated expenses. Both new and existing investors participated in the offering.
Financial Results
Full Year 2016
Immune Design ended the fourth quarter of 2016 with $110.4 million in cash and cash equivalents, short-term investments, and other receivables compared to $112.9 million as of December 31, 2015. Net cash used in operations for the year ended December 31, 2016 was $35.7 million.
Net loss and net loss per share for the year ended December 31, 2016 were $53.5 million and $2.47, respectively, compared to $39.4 million and $2.06, respectively, for the same period in 2015.
Revenue for the year ended December 31, 2016 was $13.3 million and was primarily attributable to $7.0 million in license revenue associated with Immune Design’s collaboration with Sanofi, $1.7 million in product sales to collaboration partner Sanofi and other third parties, and $4.6 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration. Revenue for the same period in 2015 was $9.5 million and was primarily attributable to $4.2 million in collaboration revenue associated with the Sanofi G103 collaboration, $3.5 million in license revenue associated with the company’s collaborations with Medimmune and Sanofi, and $1.9 million in product sales to collaboration partners Sanofi and Medimmune and other third parties.
Research and development expenses for the year ended December 31, 2016 were $45.1 million, compared to $33.1 million for the same period in 2015. The $12.0 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials.
General and administrative expenses for the year ended December 31, 2016 were $21.9 million, compared to $15.1 million for the same period in 2015. The $6.8 million increase was primarily attributable to the settlement and license agreements with TVS involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the Company, as well as related claims and counterclaims.
Fourth Quarter
Net loss and net loss per share for the fourth quarter of 2016 were $14.4 million and $0.57, respectively, compared to $12.1 million and $0.60, respectively, for the fourth quarter of 2015.
Revenue for the fourth quarter of 2016 was $2.1 million and was primarily attributable to $0.5 million in product sales to collaboration partner Sanofi and other third parties, and $1.6 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration. Revenue for the fourth quarter of 2015 was $1.1 million and was primarily attributable to $0.9 million in product sales to collaboration partners Sanofi and Medimmune and other third parties, and $0.2 million in collaboration revenue associated with the Sanofi G103 collaboration.
Research and development expenses for the fourth quarter of 2016 were $12.0 million compared to $8.9 million for the same period in 2015. The $3.1 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.
General and administrative expenses for the fourth quarter of 2016 were $4.4 million, relatively consistent with general and administrative expenses of $4.0 million recorded in the fourth quarter of 2015.
Cash Guidance
Based on current expectations, Immune Design expects to have cash to fund operations into the second half of 2018.
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 the fourth quarter and full year 2016 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 70907410.
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.