On August 12, 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 second quarter ended June 30, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, AUG 12, 2015, View Source [SID:1234507224]).

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"We have made important progress this quarter in our ongoing pivotal phase 3 ADAPT trial with AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC)," said Jeff Abbey, president and chief executive officer. "We are pleased with the independent data monitoring committee’s (IDMC) recommendation to continue the trial following the first of three planned interim data analyses. We look forward to further IDMC reviews and interim data analyses as the trial advances. In parallel, we have continued the build-out of our centralized manufacturing facility to support anticipated commercialization efforts and we recently drew down the second and final tranche of $12.5 million under our debt facility with Horizon Technology Finance Corporation and Fortress Credit Co LLC which provides us with additional capital as we continue to progress our plan to becoming a fully-integrated commercial company."

Mr. Abbey continued, "Since the close of the second quarter, we also announced two significant and exciting accomplishments, including the completion of patient enrollment in the ADAPT trial and the formation of our first ever Scientific Advisory Board, which includes world renowned physicians and scientists. We look forward to the insight and guidance these experts will provide us on the many aspects of our development programs, most importantly the continued development of AGS-003. We believe that their input will be critical as we seek to initiate additional phase 2 trials with AGS-003 in other RCC settings and additional tumor types."

Recent Operational Highlights:

In April 2015, the Company entered into a license agreement with Lummy HK for the development of personalized immunotherapies to treat cancer in China.

Lummy HK licensed the rights to manufacture, develop and commercialize AGS-003 for the treatment of cancer in China, Hong Kong, Taiwan and Macau.

Lummy HK has agreed to pay Argos a royalty on net sales of AGS-003 at a rate in the teens and up to an aggregate of $20 million for regulatory and commercial milestones.

Argos sold $10 million of its common stock to an affiliate of Lummy and the China BioPharma Capital I Fund.
In June 2015, the IDMC recommended the continuation of the company’s pivotal phase 3 ADAPT clinical trial following the first of three planned interim data analyses. This data analysis took place at the point that the Company reached approximately 25% of events.

The Second interim data analysis by the IDMC at approximately 50% of events is expected during the first half of 2016.
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 75% intermediate risk patients, meaning they present with 1 or 2 risk factors at diagnosis, and approximately 25% 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 the Company initiated an early stage RCC trial of AGS-003 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 Second Quarter 2015 Financial Results

Net loss attributable to common stockholders for the three months ended June 30, 2015 was $19.6 million, or $0.95 per share, compared to a net loss attributable to common stockholders of $12.0 million, or $0.61 per share, for the same period in 2014. Net loss attributable to common stockholders for the six months ended June 30, 2015 was $37.2 million, or $1.84 per share, compared to a net loss attributable to common stockholders of $22.8 million, or $1.52 per share, for the same period in 2014.

Revenue for the three months ended June 30, 2015 totaled $0.1 million compared to $0.5 million for the same period in 2014. Revenue for the six months ended June 30, 2015 totaled $0.3 million compared to $1.3 million for the same period in 2014.

Research and development expense for the three months ended June 30, 2015 totaled $16.1 million compared to $10.6 million for the same period in 2014. Research and development expense for the six months ended June 30, 2015 totaled $30.9 million compared to $19.0 million for the same period in 2014.

General and administrative expense for the three months ended June 30, 2015 totaled $2.9 million compared to $1.9 million for the same period in 2014. General and administrative expense for the six months ended June 30, 2015 totaled $5.3 million compared to $3.8 million for the same period in 2014.

As of June 30, 2015, Argos’ cash, cash equivalents and short-term investments totaled $30.6 million compared to $56.2 million as of December 31, 2014.