On August 9, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported financial results for the second quarter ended June 30, 2017 and provided an update on the Company’s recent corporate and operational highlights (Press release, Argos Therapeutics, AUG 9, 2017, View Source [SID1234520113]). Schedule your 30 min Free 1stOncology Demo! "Despite what has clearly been a challenging period, Argos made substantial progress during the most recent quarter," stated Jeff Abbey, CEO of Argos Therapeutics. "First, we were pleased to have a constructive meeting with the FDA, which agreed with our decision to continue the Phase 3 ADAPT trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma until we reach 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. We are grateful to our investigators and patients for their continued support of our efforts, and we look forward to our next planned analysis at 290 events, which we expect to occur during the first half of 2018."
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"In addition, we are preparing a protocol amendment and a revised statistical analysis plan seeking to extend the final data analysis beyond 290 events, which the FDA has agreed to review. We believe that this extension would enable us to better account for the potential delayed treatment effect of Rocapuldencel-T. Also of note, Robert Figlin, MD, Professor and Chairman, Division of Hematology and Oncology at Cedars Sinai Medical Center, co-principal investigator of the ADAPT trial, will provide an overview of interim data from the ADAPT trial in an oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting to be held September 8 — 12 in Madrid."
"Second, we were pleased to report positive immunogenicity data in our development program for AGS-004 for the treatment of HIV, which is funded by the NIH and the NIAID. We look forward to results from the current trial, which is being conducted at the University of North Carolina, to assess the potential ability of AGS-004, in combination with vorinostat, a latency-reversing agent, to eradicate the HIV virus in adult patients. Despite several effective therapies for HIV, there is currently no agent capable of eradicating the virus."
"Finally, we were pleased to complete a $6.0 million secured convertible note financing with our collaborator and largest shareholder, Pharmstandard. In addition, we took significant steps during the quarter to reduce our expense structure, including a substantial reduction of our workforce. These measures, coupled with proceeds we have recently raised through our at-the-market issuance facility, have enabled us to extend our operational runway. "
Second Quarter 2017 and Recent Operational Highlights:
In May 2017, the Company reported that the FDA agreed with the Company’s plan to continue the ADAPT trial until the Company reaches 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted, and that the FDA agreed to review a protocol amendment and revised statistical analysis plan that would extend the trial beyond the originally planned 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect
In June 2017, the Company announced the closing of a $6.0 million secured convertible note financing with Pharmstandard
In July 2017, the Company reported positive immunogenicity data in its AGS-004 dendritic cell therapy program for the treatment of adult patients with acute HIV infection
Selected Second Quarter 2017 Financial Results
Revenue for the three months ended June 30, 2017 was $70,000 compared to $489,000 for the same period in 2016. The decrease in revenue for the second quarter of 2017 compared with the second quarter of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.
Research and development expense for the three months ended June 30, 2017 was $5.1 million compared to $9.2 million for the same period in 2016. The decrease in research and development expense for the second quarter of 2017 compared with the second quarter of 2016 was primarily due to the Company’s decision to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial.
General and administrative expense for the three months ended June 30, 2017 was $2.7 million compared to $3.4 million for the same period in 2016. The decrease in general and administrative expense for the second quarter of 2017 compared with the second quarter of 2016 was primarily due to reduced consulting and personnel costs.
Reflecting the factors noted above, net loss for the three months ended June 30, 2017 was $8.5 million compared to a net loss of $12.6 million for the same period in 2016.
Revenue for the six months ended June 30, 2017 was $175,000 compared to $635,000 for the same period in 2016. The decrease in revenue for the first half of 2017 compared with the first half of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.
Research and development expense for the six months ended June 30, 2017 was $13.0 million compared to $18.7 million for the same period in 2016. The decrease in research and development expense for the first half of 2017 compared with the first half of 2016 was primarily due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial.
General and administrative expense for the six months ended June 30, 2017 was $6.6 million compared to $6.4 million for the same period in 2016. The increase in general and administrative expense for the first half of 2017 compared with the first half of 2016 was primarily due to increased personnel costs.
Additionally, the Company incurred impairment charges of $27.2 million and restructuring charges of $5.4 million during the six months ended June 30, 2017 related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.2 million.
Reflecting the factors noted above, net loss for the six months ended June 30, 2017 was $32.6 million compared to a net loss of $25.4 million for the same period in 2016.
As of June 30, 2017, cash and cash equivalents totaled $9.3 million.