Public Company Information:
SAN DIEGO & RICHMOND, Va. & LJUBLJANA, Slovenia & SYDNEY--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (OTCQB: APHBD), a global leader in the development of bacteriophage-based antibacterial therapies to treat antibiotic-resistant infections, today reported financial results for the second quarter ended June 30, 2015 and highlighted operational achievements.
“In the second quarter, AmpliPhi made significant progress towards achieving our near and longer-term clinical and commercial objectives. We received cGMP manufacturing clearance, a key objective on our path to initiating our first clinical trial program and applied to uplist the Company on the NYSE MKT, following our successful reverse split,” said M. Scott Salka, CEO of AmpliPhi Biosciences.
Highlights Reflect Continued Corporate Advancements
- Received formal written clearance from JAZMP, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices, to manufacture bacteriophages under current Good Manufacturing Practices (cGMP) standards in our dedicated bacteriophage production facility
- Presented to EMA Workshop in London on the therapeutic use of bacteriophages in June
- Presented data at the 38th European Cystic Fibrosis Conference in June demonstrating anti-pseudomonal bacteriophages retained biological activity following nebulization
- Presented on the medical priorities and commercial development of phage therapies at the National Institute of Allergy and Infectious Disease (NIAID) bacteriophage workshop on drug resistance in July
- Accepted to present data at the joint Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 meeting, in September, showing efficacy of bacteriophage evaluated against vancomycin in a Staphylococcus aureus lung infection mouse model. These data further underscore the applicability of phage-based approaches to treat lung infections
- Completed a one-for-fifty reverse split of the Company’s common stock, reducing the number of common shares outstanding from approximately 289 million to approximately 5.8 million effective at market open on August 7, 2015
- Submitted application for AmpliPhi Biosciences to be listed on the NYSE MKT exchange
Second Quarter 2015 Financial Results:
Following a $13 million financing in March, the Company has significantly improved overall liquidity and balance sheet strength in preparation for an anticipated listing on a major national stock exchange.
- Second quarter 2015 R&D expenses totaled $1.1 million from $1.9 million for the same period of 2014. The reduced R&D expenses were due primarily to the timing of non-clinical research project fees in 2015 and one-time start-up costs in 2014 related to our Slovenia cGMP manufacturing facility
- Second quarter 2015 G&A expenses totaled $1.6 million compared to $2.0 million in the second quarter of 2014. The reduced G&A expenses were due primarily attributable to lower cash and stock compensation expenses related to the departure of our prior Chief Executive Officer in the third quarter of 2014, which were partially offset by expenses related to the appointment of our new Chief Executive Officer on May 18, 2015
- Loss from operations for the quarter ended June 30, 2015 was $2.6 million compared to $3.7 million in the same period of 2014
- Net income for the second quarter 2015 was $10.8 million compared to $13.9 million in the same period of 2014
- Cash and cash equivalents as of June 30, 2015 totaled $14.4 million, reflecting the net proceeds of $12.4 million from our March 2015 private placement financing
- The Company anticipates its current financial resources will provide sufficient cash to fund operations through Q3 2016
“AmpliPhi remains in a solid position, operationally and financially, to advance our pre-clinical pipeline and achieve our overarching goal of bringing bacteriophage-based products to market to provide clinicians with a new class of therapies to combat the rising threat of antibiotic-resistant bacterial infections,” concluded Salka.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (OTCQB: APHBD) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE: XON), the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies.
For more information, visit www.ampliphibio.com.
Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defence for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to produce strong local therapeutic effects.
Forward Looking Statements
Statements in this press release about the potential listing of the Company’s common stock on the NYSE MKT, potential improvements in the marketability of the Company’s securities, the Company’s projection of financial resources, the ability of the Company to execute on its near term objectives, the potential use of bacteriophages to treat bacterial infections, including Staphylococcus aureus lung infections, infections in biofilms and infections that do not respond to antibiotics, and the development of bacteriophage-based therapies are forward looking statements subject to risks and uncertainties, including without limitation the risk that the Company will not satisfy the listing criteria of the NYSE MKT, that the trading price of the Company’s common stock may decline following the reverse split, that the Company will not be able to successfully manufacture sufficient quantities of products to conduct clinical trials or commercialize products in a timely manner or at all, that AmpliPhi may not commence clinical trials or complete IND-enabling studies as expected, that the clinical trials will not be successful, that further development of the Company's products will require extensive and expensive nonclinical and clinical testing, may not be safe or efficacious, and may not be approved for marketing by the United States Food and Drug Administration or any foreign regulatory agency. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to AmpliPhi's business in general, see AmpliPhi's Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, filed with the Securities and Exchange Commission (SEC) on April 15, 2015.
Company and Investor relations:
AmpliPhi Biosciences Corporation
Baxter Phillips III
Chief Business Officer
Media relations (USA)
Danielle Lewis/Rob Sawyer
Media Relations (Europe and ROW)
Gemma Howe/Sue Charles
+44 (0)20 7457 2020