On November 14, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the third quarter ended September 30, 2016 and reported on the company’s corporate and operational highlights (Press release, Argos Therapeutics, NOV 14, 2016, View Source [SID1234516560]).
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"During the third quarter, we further strengthened our management team and financial position," said Jeff Abbey, president and chief executive officer. "As we previously announced, Dr. Richard Katz joined us as chief financial officer in July. Rich has already played an instrumental role by driving the most recent financing, in which we raised gross proceeds of $50 million. In addition, he has initiated the transformation of our finance structure towards that of a commercial stage company."
"Our Phase 3 ADAPT study of AGS-003 in advanced renal cell carcinoma continues to progress and we look forward to the next Independent Data Monitoring Committee meeting in February, followed by anticipated top-line data in the first half of 2017," Mr. Abbey stated. "In addition, in July the first patient was dosed in Stage 2 of the investigator-initiated adult HIV eradication trial of AGS-004 in combination with the latency reversing drug vorinostat being conducted at the University of North Carolina, Chapel Hill. This is the first clinical trial evaluating the ‘kick and kill’ approach employing an HIV latency-reversing drug combined with an individualized immunotherapy. This is an exciting step, as it represents another promising opportunity to demonstrate the versatility of our Arcelis platform technology."
Third Quarter 2016 and Recent Operational Highlights:
In July 2016, Richard D. Katz, MD, joined the company as chief financial officer
In July 2016, the first patient was dosed in Stage 2 of the investigator-initiated adult HIV eradication trial of AGS-004
In August 2016, the company completed an equity financing with gross proceeds of $50 million
Selected Third Quarter 2016 Financial Results
Net loss for the three months ended September 30, 2016 was $12.2 million, or $0.32 per share, compared to a net loss of $20.1 million, or $0.97 per share, for the same period in 2015. Net loss for the nine months ended September 30, 2016 was $37.7 million, or $1.30 per share, compared to a net loss of $57.2 million, or $2.81 per share, for the same period in 2015.
Revenue for the three months ended September 30, 2016 totaled $0.1 million compared to $0.2 million for the same period in 2015. Revenue for the nine months ended September 30, 2016 totaled $0.8 million compared to $0.4 million for the same period in 2015.
Research and development expense for the three months ended September 30, 2016 totaled $9.3 million compared to $17.2 million for the same period in 2015. Research and development expense for the nine months ended September 30, 2016 totaled $28.0 million compared to $48.1 million for the same period in 2015.
General and administrative expense for the three months ended September 30, 2016 totaled $3.0 million compared to $2.7 million for the same period in 2015. General and administrative expense for the nine months ended September 30, 2016 totaled $9.4 million compared to $8.0 million for the same period in 2015.
As of September 30, 2016, cash and cash equivalents totaled $69.3.
Upcoming Investor Day
As previously announced, the company will host an Investor Day on Wednesday, December 7, 2016 from 8:00-11:00 a.m. Eastern Time at NASDAQ MarketSite in New York City. A live and archived audio webcast of the Investor Day can be accessed through the Investors section of the company’s website at www.argostherapeutics.com.
Argos’ management will review the scientific, clinical and commercial opportunity behind the company’s lead product candidate, AGS-003, which is currently being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of advanced renal cell carcinoma. Gerald Linette, MD, PhD, chief medical officer for cancer immunotherapy at the University of Pennsylvania Abramson Cancer Center, and Christopher Wood, MD, FACS, professor of urology, division of surgery at the University of Texas MD Anderson Cancer Center will join management in discussing AGS-003 and the treatment landscape.
Third Quarter 2016 Financial Results Conference Call and Webcast Details
Argos management will host a conference call beginning at 8:30 a.m. Eastern Time today to discuss these results and to answer questions.
To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 15427740. A live and archived audio webcast can be accessed through the Investors section of the company’s website at www.argostherapeutics.com. The archived webcast will remain available on the company’s website for twelve (12) months following the call.
About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.