On March 29, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the fourth quarter and full-year ended December 31, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAR 29, 2016, View Source [SID:1234510104]).
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"In the past year we have achieved a number of important milestones, both from a clinical and a corporate perspective," said Jeff Abbey, president and chief executive officer. "In July, we successfully completed enrollment of our Phase 3 ADAPT trial of AGS-003 in metastatic renal cell carcinoma. The ADAPT trial also successfully navigated two data analyses, in June and December, by the Independent Data Monitoring Committee (IDMC). The next review of data by the IDMC is scheduled to take place in June of 2016. We expect a subsequent IDMC meeting and review of data to occur in late 2016 and anticipate having a sufficient number of events from the ADAPT trial to permit the primary analysis and assessment of overall survival to occur in the first half of 2017."
"We also successfully formed our Scientific Advisory Board in 2015. These highly-regarded individuals are a significant resource as we continue to advance our clinical development programs," said Mr. Abbey. "Additionally, we also saw the initiation of an early stage investigator-sponsored RCC trial of AGS-003 at Roswell Park Cancer Institute in Buffalo, NY. With this study, for the first time we will assess the effects of AGS-003 in patients with kidney cancer that has not spread to nearby lymph nodes or other parts of the body. As we have emphasized, this is an important opportunity to manufacture AGS-003 using a needle biopsy procedure for tumor collection prior to surgery, while directly studying immune changes within the primary tumor before and after administration of AGS-003."
Mr. Abbey continued, "With the accomplishments of 2015 and those we have already announced in 2016, including the hiring of Dr. Lee Allen as our chief medical officer, the initiation of an investigator-sponsored trial of AGS-003 in non-small cell lung cancer, and our recently announced financing of up to $60 million, which, if it is funded in full, should fund our operations into the second quarter of 2017 when we anticipate final data of the ADAPT trial, we believe we have taken many of the necessary steps to be successful."
2015 Operational Highlights:
In June and December 2015, following data reviews, the IDMC recommended continuation of the pivotal Phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of mRCC
In July 2015, the ADAPT clinical trial reached its enrollment goal of at least 450 randomized patients
462 patients enrolled
The breakdown of patients enrolled in the ADAPT study is approximately 73% intermediate risk patients, meaning they present with 1 or 2 risk factors at diagnosis, and approximately 27% poor risk patients, meaning they present with either 3 or 4 risk factors at diagnosis
In July 2015, the Company established a Scientific Advisory Board (SAB)
Inaugural members include distinguished oncologists and immunologists to provide perspectives in further research and development of AGS-003
In July 2015, an investigator-initiated early stage RCC trial of AGS-003 commenced at Roswell Park Cancer Institute in Buffalo, NY
Preliminary data expected in the fourth quarter of 2015
Selected Third Quarter 2015 Financial Results
Net loss attributable to common stockholders for the three months ended December 31, 2015 was $17.6 million, or $0.84 per share, compared to a net loss attributable to common stockholders of $16.2 million, or $0.83 per share, for the same period in 2014. Net loss attributable to common stockholders for the full-year ended December 31, 2015 was $74.8 million, or $3.66 per share, compared to a net loss attributable to common stockholders of $54.2 million, or $3.12 per share, for the same period in 2014.
Revenue for the three months ended December 31, 2015 totaled $0.1 million compared to $0.3 million for the same period in 2014. Revenue for the full-year ended December 31, 2015 totaled $0.5 million compared to $2.0 million for the same period in 2014.
Research and development expense for the three months ended December 31, 2015 totaled $14.0 million compared to $13.5 million for the same period in 2014. Research and development expense for the full-year ended December 31, 2015 totaled $62.1 million compared to $45.5 million for the same period in 2014.
General and administrative expense for the three months ended December 31, 2015 totaled $3.0 million compared to $2.5 million for the same period in 2014. General and administrative expense for the full-year ended December 31, 2015 totaled $11.0 million compared to $8.6 million for the same period in 2014.
As of December 31, 2015, Argos’ cash, cash equivalents and short-term investments totaled $7.2 million compared to $56.2 million as of December 31, 2014.
About the Arcelis Technology Platform
Arcelis is a truly personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.