On May 14, 2015 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis technology platform, reported financial results for the first quarter ended March 31, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 14, 2015, View Source [SID:1234504337]).

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"We continue to make strong progress in our clinical programs," said Jeff Abbey, president and chief executive officer. "Data from the previously conducted phase 2 clinical trial of AGS-003 in metastatic renal cell carcinoma (mRCC) were recently published in the Journal for ImmunoTherapy of Cancer and showed that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival. In addition, patients with intermediate risk mRCC experienced a median survival in excess of 5 years. Expected median survival for these patients treated with sunitinib as their first line targeted therapy is approximately 20.5 months. These and the other findings of the trial are being further evaluated in the ongoing phase 3 ADAPT trial. We look forward to an interim data analysis for this trial by the Independent Data Monitoring Committee, or IDMC, at approximately 25% of events which we expect will occur during the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting."

Mr. Abbey continued, "We are also pleased to have recently entered into an agreement with Lummy HK, under which they licensed from us the rights to manufacture, develop and commercialize AGS-003 for the treatment of cancer in China, Hong Kong, Taiwan and Macau. We believe this agreement provides further validation of AGS-003 to treat not only mRCC, but potentially others cancers as well, and look forward to the development of this promising product candidate to treat a new population of patients with high unmet medical needs."

Recent Highlights and Anticipated Milestones

Data from the previously conducted phase 2 clinical trial of AGS-003 published in the Journal for ImmunoTherapy of Cancer
The data from the trial show that treatment with AGS-003 in combination with sunitinib was safe, well tolerated and associated with immunologic responses and extended survival
Median overall survival for all patients was 30.2 months and median overall survival for intermediate risk patients was over 5 years
Observations from the trial indicate that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival

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

NIH Division of Aids (DAIDS) approved $6.6 million in funding for the investigator-initiated phase 2 adult eradication study of AGS-004, the company’s investigational fully personalized immunotherapy for HIV
Allows stage two of the adult eradication trial to move forward; the trial has already been cleared for initiation by the FDA

Received the Economic Development Award at the 17th annual Triangle Commercial Real Estate Women (Triangle CREW)
Champion Awards

Argos recognized for its plans to expand into a new 100,000 square foot manufacturing facility currently under construction and create nearly 250 jobs in Durham, NC

Initiation of an investigator-initiated phase 2 pediatric trial of AGS-004 planned for second half of 2015

Continue the build-out and equipping of Argos’ automated commercial manufacturing facility

Full enrollment of the phase 3 ADAPT trial for AGS-003 in mRCC expected by the end of second quarter 2015

Interim data analysis from the ADAPT trial by the IDMC at approximately 25% of events expected during the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Dr. Robert Figlin, Principal Investigator, will present an update from the ADAPT trial at ASCO (Free ASCO Whitepaper) during the Genitourinary (Nonprostate) Cancer poster session on Monday, June 1st from 1:15-4:45pm CT
Poster titled "Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience" (abstract TPS4582)

Selected First Quarter 2015 Financial Results

Revenue for the three months ended March 31, 2015 totaled $0.2 million compared to $0.8 million for the same period in 2014. Net loss attributable to common stockholders for the three months ended March 31, 2015 was $17.5 million, or $0.89 per share, compared to a net loss attributable to common stockholders of $10.9 million, or $1.05 per share, for the same period in 2014. Research and development expense for the three months ended March 31, 2015 totaled $14.8 million compared to $8.5 million for the same period in 2014. General and administrative expense for the three months ended March 31, 2015 totaled $2.4 million compared to $1.9 million for the same period in 2014.

As of March 31, 2015, Argos’ cash, cash equivalents and short-term investments totaled $39.2 million compared to $56.2 million as of December 31, 2014.

Five Prime Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Five Prime Therapeutics, MAY 14, 2015, View Source [SID1234504283]).

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Soligenix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Soligenix, MAY 14, 2015, View Source [SID1234504323]).

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On May 14, 2015 Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) reported that updated data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine under development at the Company’s wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Generex, MAY 14, 2015, http://www.prnewswire.com/news-releases/generex-provides-data-update-from-ae37-phase-ii-breast-cancer-trial-one-year-post-completion-of-enrollment-300082832.html [SID:1234506564]). The current analysis was performed on data that was examined one year after the last patient was enrolled into the trial. The ASCO (Free ASCO Whitepaper) meeting will be held from May 29 to June 2, 2015 in Chicago, IL.

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The abstract, entitled ‘Final Pre-specified Analysis of the Phase II Trial of the AE37+GM-CSF Vaccine in High Risk Breast Cancer Patients to Prevent Recurrence", by Julia Greene, et al will be presented on May 30 during the Breast Cancer – HER2/ER session. The study reports on the anticipated five year disease free survival in patients enrolled in a controlled, randomized, and single-blinded Phase II trial that completed enrollment in January of 2014. A prior interim analysis conducted in 2011, as well as a primary efficacy analysis conducted in 2013, pointed to a benefit of the AE37 vaccine in patients not receiving Herceptin and, in particular, patients with triple negative breast cancer. This latter group represents a patient population of high unmet need. The present study continues to show a trend in this population, with a 35% reduction in the relative risk of recurrence in patients receiving the AE37 vaccine.

The AE37 cancer vaccine is distinguished among other cancer vaccines by its ability to specifically activate CD4+ T helper cells, which are critical in generating an effective immune response. The improved immunological potency, together with an excellent safety profile, offer particular advantages for combination with other targeted or immunological therapies. In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. In that study it was shown that, even three years after receiving the last dose of AE37, patients consistently displayed a vigorous reaction, demonstrating a long-lasting, specific, and robust response to AE37.

On May 14, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, reported first quarter 2015 financial results and recent business highlights.

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"In the first quarter of 2015 we demonstrated strong progress in our pipeline, including the presentation of initial clinical data for LOXO-101 at AACR (Free AACR Whitepaper) and the unveiling of three additional preclinical programs. Our focus on targeted cancer therapies with best-in-class potential reflects our belief that selective, rationally designed drugs can demonstrate clinical benefit and differentiation when tested in patients with the relevant oncogene addicted tumors," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We are pleased that initial data from our Phase 1a trial of LOXO-101 show that the drug is achieving biologically relevant exposures, while revealing no clear drug-related safety signals. We look forward to moving into exclusively TRK-altered patients in the second half of the year and continuing to advance our pipeline."

Recent Business Highlights

Presented Initial Phase 1a Data for LOXO-101 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting

In April, the Company presented initial Phase 1a safety and pharmacokinetic data for LOXO-101 in a poster session at the AACR (Free AACR Whitepaper) 2015 Annual Meeting in Philadelphia. Key findings from the poster presentation included:

As of the data cut-off for the poster, March 26, 2015, 15 patients had been enrolled across three dose cohorts: 50mg QD (n=4), 100mg QD (n=5), and 100mg BID (n=6), including one soft tissue sarcoma patient with an NTRK1 fusion enrolled on March 10, 2015

Pharmacokinetics showed good systemic exposure of LOXO-101 after oral dosing, with higher exposures observed than those predicted in nonclinical studies

LOXO-101 was generally well tolerated, with the most common adverse events being Grade 1 and 2 fatigue, dizziness and anemia; no study drug related serious adverse events (SAEs) were reported; the maximum tolerated dose (MTD) had not yet been reached.

Updated Program Guidance for 2015

On March 2, 2015, the Company updated its 2015 program guidance, unveiling molecular targets for three of its seven active preclinical programs. The three targets disclosed were Rearranged during Transfection (RET), Fibroblast Growth Factor Receptor (FGFR), and FMS-Like Tyrosine kinase 3 (FLT3). In addition to these three programs, Loxo possesses well-vetted candidates for two other programs, not yet disclosed by target name, which are ready for IND-enabling work. All of the Company’s current preclinical pipeline programs are being pursued as part of Loxo’s collaboration with Array BioPharma. The Company will provide periodic data updates for its discovery pipeline at medical meetings, beginning in the second half of 2015.

Appointed New Vice President of Finance, Jennifer Burstein, CPA

In early May, Loxo appointed Ms. Jennifer Burstein, CPA, as vice president of finance. Jennifer will be the Company’s principal financial officer and principal accounting officer. Prior to Loxo, Ms. Burstein served as vice president of finance at Acorda Therapeutics, Inc., a public biotechnology company, from July 2010 until April 2015, where she held several positions of increasing responsibility in finance from 2006 until being appointed vice president of finance. Prior to joining Acorda, from 2002 to 2006, she was with Eyetech Pharmaceuticals, Inc., a public biotechnology company, which is currently a subsidiary of Valeant Pharmaceuticals International, Inc., where she held several positions of increasing responsibility in finance until being promoted to senior director, accounting. Before Eyetech, Ms. Burstein worked in the finance departments at several companies and in public accounting. Ms. Burstein received her B.S. in business administration and M.B.A. in accounting from the State University of New York at Buffalo and has a CPA license in New York.

Upcoming Poster Presentations at ASCO (Free ASCO Whitepaper) Annual Meeting

Loxo reported it will present two posters at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, Illinois on May 29-June 2, 2015. Loxo will not be presenting new clinical data at this meeting.

The details of the poster sessions are as follows:

Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date: Saturday, May 30
Poster Viewing Session: 8:00 – 11:30a.m. CDT
Location: S Hall A
Poster Number: 328b
Title: A first-in-human study of LOXO-101, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family. (Abstract # TPS2624, Trials in Progress)
Lead Author: Howard A. Burris, M.D.

Poster Session: Cancer Prevention, Genetics, and Epidemiology
Date: Monday, June 1
Poster Viewing Session: 1:15-4:45p.m. CDT
Location: S Hall A
Poster Number: 377
Title: Identification of tropomyosin kinase receptor (TRK) mutations in cancer. (Abstract # 1553)
Lead Author: Nisha Nanda, Ph.D.
First Quarter 2015 Financial Results

As of March 31, 2015 Loxo had aggregate cash, cash equivalents and investments of $107.6 million, compared to $112.9 million as of December 31, 2014.

The Company continues to expect cash burn of $30-$33 million in 2015, and based on the current operating plan, the Company believes existing capital resources will be sufficient to fund anticipated operations into 2017.

Research and development expenses were $3.8 million for the first quarter of 2015 compared to $2.0 million in the first quarter of 2014. This increase of $1.8 million was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The Company also recognized stock-based compensation expense of $0.5 million during the first quarter of 2015 compared to $40,000 for the first quarter of 2014.

General and administrative expenses were $2.4 million for the first quarter of 2015 compared to $0.9 million in the first quarter of 2014. The increase of $1.5 million was primarily due to increased costs associated with operating as a public company. The Company also recognized stock-based compensation expense of $0.6 million during the first quarter 2015 compared to $20,000 for the first quarter 2014.

Net loss attributable to common shareholders was $6.2 million and $2.9 million for the first quarters 2015 and 2014, respectively.

The Company will not be conducting a conference call in conjunction with this earnings release. Loxo plans to continue its tradition of conducting an earnings conference call in conjunction with its fourth quarter earnings releases.