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Inovio Pharmaceuticals Reports 2015 First Quarter Financial Results
Globe Newswire
May 11, 2015: 07:00 AM ET
PLYMOUTH MEETING, Pa., May 11, 2015 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (Nasdaq:INO) today reported financial results for the quarter ended March 31, 2015.
Total revenue was $5.2 million for the three months ended March 31, 2015, compared to $2.4 million for the same period in 2014. Total operating expenses were $13.5 million compared to $12.4 million.
The net loss attributable to common stockholders for the quarter ended March 31, 2015, was $10.6 million, or $0.17 per share, compared to $10.8 million, or $0.20 per share, for the quarter ended March 31, 2014.
Revenue
The increase in revenue was primarily due to payments received from Roche under our partnership agreement established in September 2013.
Operating Expenses
Research and development expenses for Q1 2015 were $9.4 million compared to $8.2 million for Q1 2014. The increase in R&D expenses was generally related to increased investment in all our product development programs. General and administrative expenses were $4.1 million for Q1 2015 versus $4.1 million for Q1 2014.
Capital Resources
As of March 31, 2015 cash and cash equivalents and short-term investments were $81.0 million compared with $93.6 million as of December 31, 2014. At quarter end the company had 60.7 million shares outstanding and 67.8 million fully diluted.
On May 5, 2015, the Company closed an underwritten public offering of 10,925,000 shares of the Company's common stock, including 1,425,000 shares of common stock issued pursuant to the underwriter's exercise of its option, at the public offering price of $8.00 per share. The gross proceeds of this offering were $87.4 million. Net proceeds to the Company, after deducting the underwriter's discounts and commission and other estimated offering expenses payable by the Company, were approximately $82.1 million.
We intend to use the net proceeds received from the sale of our common stock for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses, manufacturing expenses and potential acquisitions of companies and technologies that complement our business.
Based on management's projections and analysis, the Company believes that cash, cash equivalents and short-term investments are sufficient to meet its planned working capital requirements, including the cost of its planned phase III clinical trial of VGX-3100, through the end of 2018.
Inovio's balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2015 first quarter financial report can be found at: http://ir.inovio.com/secfilings.
Corporate Update
Clinical Development
Detailed study findings from our phase II study of VGX-3100 in patients with high-grade cervical dysplasia have been submitted in a manuscript for peer review with the goal of publication in a medical journal. In this study we achieved our primary and secondary endpoints, with statistical significance in regressing high grade cervical dysplasia from CIN2/3 to CIN1 or no disease and clearing HPV. Robust and durable T-cell activity was detected in subjects who received VGX-3100 compared to those who received placebo. There were no serious adverse events.
We are preparing to launch a phase III registration study of VGX-3100 in early 2016. Necessary steps include scaling up commercial-level production of our immunotherapy product and delivery devices, and completing an end-of-phase-II meeting with the FDA.
As part of our expanding franchise targeting all HPV-associated precancers and cancers, we reported preliminary data from our first cancer study, a head & neck cancer trial, showing that INO-3112 (VGX-3100 plus Inovio's IL-12 based immune activator) generated strong CD8+ T cell responses in 3 of 4 patients.
We received regulatory approval to initiate a phase I study of our prostate cancer DNA immunotherapy, INO-5150, targeting prostate-specific membrane antigen and prostate-specific antigen. We intend to begin enrolling patients in 2Q 2015.
We initiated with our partner Roche a phase I trial for our hepatitis B immunotherapy, INO-1800. This randomized, open-label, active-controlled, dose escalation study is evaluating the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy alone or in combination with Inovio's IL-12-based immune activator.
With collaborators under a DARPA-funded project (see Corporate Development below), we expect to start a phase I study of our Ebola immunotherapy, INO-4212, in 2Q 2015. Inovio published data in 2013 showing 100% protection of animals immunized with our Ebola DNA immunotherapy.
We reported that in a 12-patient phase I study our single-clade PENNVAX®-B HIV immunotherapy induced in HIV-infected patients CD8+ T cells with functional characteristics similar to those of long-term non-progressors (rare HIV-infected individuals who, without treatment, do not progress to further stages of the disease): "Synthetic consensus HIV-1 DNA induces potent cellular immune responses and synthesis of granzyme B, perforin in HIV infected individuals," Molecular Therapy. Building on these data, we created our global, multi-clade PENNVAX®-GP preventive and therapeutic HIV DNA immunotherapy candidate with funding via a $25 million NIH contract. We expect the HVTN to initiate a phase I study of PENNVAX®-GP in 2Q 2015.
Our phase I/IIa studies of INO-3112 in head & neck and cervical cancers; INO-1400 (hTERT antigen) in breast, lung or pancreatic cancer patients; and INO-8000, targeting hepatitis C virus genotypes 1a and 1b, in collaboration with GeneOne Life Sciences, Inc., are ongoing.
Corporate Development
The initiation of the phase I trial for Inovio's hepatitis B multi-antigen DNA immunotherapy, INO-1800, triggered a $3 million milestone payment from Roche, which exclusively licensed this product in 2013.
The National Institute of Allergy and Infectious Diseases (NIAID) awarded Inovio and its collaborators (University of Pennsylvania (primary), Emory University, Duke University, University of Massachusetts, VGXi, and Waisman Biomanufacturing) a five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development Program to expand the coverage of Inovio's PENNVAX HIV vaccine to additional HIV strains and advance new technologies to further improve vaccination outcomes.
Under an award worth potentially $45 million from the Defense Advanced Research Projects Agency (DARPA), Inovio (primary) is collaborating with MedImmune as well as GeneOne Life Sciences and its manufacturing subsidiary, VGXI, Inc., University of Pennsylvania, Emory University and Vanderbilt University to advance multiple treatment and prevention approaches against Ebola. These approaches include Inovio's therapeutic DNA-based monoclonal antibody technology, MedImmune's protein-based therapeutic monoclonal antibodies, and Inovio's DNA-based vaccines. This award follows on a $12.2 million DARPA grant awarded last September under which Inovio, MedImmune, and scientists from the University of Pennsylvania (primary) are collaborating to develop and assess DNA-based monoclonal antibodies for influenza and antibiotic resistant bacteria.
For the third consecutive year, Inovio was recognized by industry peers at the World Vaccine Congress for "Best Therapeutic Vaccine" for its DNA-based immunotherapy, VGX-3100. In addition, the laboratory of Dr. David B. Weiner, Chair of Inovio's Scientific Advisory Board and Professor of Pathology and Laboratory Medicine at The Perelman School of Medicine at the University of Pennsylvania, was awarded "Best Academic Research Team." Through Inovio's license agreement with the University of Pennsylvania, Dr. Weiner's laboratory is advancing DNA immunotherapy technology and products that form the foundation of Inovio's product portfolio.
Inovio continues its corporate development efforts to secure grants, collaborations, and partnerships to help advance its SynCon® immunotherapy and vaccine products.
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发表于 2015-5-12 10:07