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]).
On May 14, 2015 Heat Biologics reported its financial results for the first quarter ended March 31, 2015.
First Quarter 2015 Highlights & Recent Developments
· Presented positive immunological data on HS-410 (vesigenurtacel-L) in non-muscle-invasive bladder cancer (NMIBC)
o At the 7th Annual Phacilitate Immunotherapy Forum, data were presented showing a strong immune response, that correlated with a clinical response, in a HS-410 treated patient, supporting the mechanism of action of ImPACT therapy
o At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, provided an update on immune responder and non-responder phenotypes from the phase I clinical trial of HS-410 in NMIBC.
· Received US FDA "Fast-Track" designation for HS-410 in combination with BCG for the treatment of non-muscle invasive bladder cancer
· Presented preclinical data on a novel approach to combination immunotherapy at the Keystone Symposia on Tumor Immunology
o Data presented demonstrate strategy for vaccine and co-stimulation in a single-cell based product
· Announced collaboration with OncoSec Medical to evaluate
combination immunotherapy platforms
· Announced initiation of a new Phase 1b trial of Viagenpumatucel-L (HS-110) in non-small cell lung cancer (NSCLC)
oTrial will explore combination of HS-110 with various immune checkpoint agents
· Raised net proceeds of approximately $11.1 million in an underwritten public offering
"We are pleased to report continued positive momentum with our lead clinical programs in NMIBC and NSCLC," said Jeff Wolf, Heat’s CEO. "We look forward to achieving several additional clinical milestones this year, including interim immune response data from the ongoing Phase 2 trial in NSCLC and completion of enrollment in the Phase 2 trial in NMIBC. The successful public financing we completed in March of this year puts us in a stronger financial position to execute on our development activities."
Quarter Ended March 31, 2015 vs. Quarter Ended March 31, 2014
Research and development expenses for the first quarter of 2015 decreased 6% compared to the first quarter of 2014. Clinical and regulatory expenses were $2.2 million compared to $0.8 million for the first quarter of 2014. The increase was attributable to increases in clinical trial execution costs, increased investigator payments, and other costs related to the manufacturing of vaccines for clinical trials.
General and administrative expenses for the quarter were $1.3 million compared to $1.0 million for the first quarter of 2014. The increase from the first quarter of 2014 was attributable to increases related to professional services, personnel costs as well as an increase in non-cash stock compensation.
Net loss attributable to common stockholders was $3.9 million, or ($0.57) per basic and diluted share for the first quarter of 2015. This compares to a net loss of $2.3 million, or ($0.36) per basic and diluted share for the first quarter of 2014.
As of March 31, 2015, the Company had approximately $21.1 million in cash, cash equivalents, and short-term investments. This balance includes the $11.1 million net proceeds from the March 2015 offering and subsequent over-allotment option.
Heat Biologics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Heat Biologics, MAY 14, 2015, View Source [SID1234504324]).
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]).
"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)
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.
TetraLogic Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, TetraLogic Pharmaceuticals, MAY 14, 2015, View Source [SID1234504333]).