On November 16, 2015 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the third quarter ended September 30, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, NOV 16, 2015, View Source [SID:1234508242]).

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"We continue to advance toward our goal of becoming a fully-integrated commercial biotechnology company," said Jeff Abbey, president and chief executive officer. "We successfully completed enrollment in our phase 3 ADAPT trial of AGS-003 in metastatic renal cell carcinoma. The ADAPT trial continues to progress in line with our expectations and we anticipate the next interim data analysis, at approximately fifty percent of events, to occur in the first half of 2016. Additionally, an early stage investigator-initiated RCC trial of AGS-003 was begun at Roswell Park Cancer Institute in Buffalo, NY. With this study, for the first time we will be able to 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. 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."

"Also during the quarter, Argos formed its first Scientific Advisory Board to assist us with the continued advancement of our clinical development programs. We look forward to working closely with these renowned scientists and physicians as we design new trials of AGS-003 over the coming quarters in a variety of tumor types." Mr. Abbey went on, "We continue to take the steps and make the necessary investments in our centralized commercial manufacturing facility here in Durham. Lastly, as part of our debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC, we drew down the second and final tranche of $12.5 million, which has helped provide us with additional capital to conduct critical operational activities."

Recent Operational Highlights:

In July 2015, the pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with standard targeted therapy for the treatment of mRCC reached its enrollment goal of at least 450 randomized patients.

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.
In August 2015, the Company received the second and final tranche of $12.5 million under its debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC.

Selected Third Quarter 2015 Financial Results

Net loss attributable to common stockholders for the three months ended September 30, 2015 was $20.1 million, or $0.97 per share, compared to a net loss attributable to common stockholders of $15.1 million, or $0.77 per share, for the same period in 2014. Net loss attributable to common stockholders for the nine months ended September 30, 2015 was $57.2 million, or $2.81 per share, compared to a net loss attributable to common stockholders of $37.9 million, or $2.29 per share, for the same period in 2014.

Revenue for the three months ended September 30, 2015 totaled $0.2 million compared to $0.4 million for the same period in 2014. Revenue for the nine months ended September 30, 2015 totaled $0.4 million compared to $1.7 million for the same period in 2014.

Research and development expense for the three months ended September 30, 2015 totaled $17.2 million compared to $13.0 million for the same period in 2014. Research and development expense for the nine months ended September 30, 2015 totaled $48.1 million compared to $32.0 million for the same period in 2014.

General and administrative expense for the three months ended September 30, 2015 totaled $2.7 million compared to $2.3 million for the same period in 2014. General and administrative expense for the nine months ended September 30, 2015 totaled $8.0 million compared to $6.1 million for the same period in 2014.

As of September 30, 2015, Argos’ cash, cash equivalents and short-term investments totaled $23.1 million compared to $56.2 million as of December 31, 2014.