Earnings Labs

Armata Pharmaceuticals, Inc. (ARMP)

Q4 2015 Earnings Call· Wed, Mar 30, 2016

$9.56

-13.14%

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Transcript

Operator

Operator

Good afternoon and welcome to the AmpliPhi Biosciences Full-Year 2015 Financial Results Conference Call. Today’s call is being recorded. For opening remarks and introductions, I’d like to turn the call over to Matt Dansey, Business Development Manager. Please go ahead, sir.

Matt Dansey

Management

Thanks. During the call, we will make statements related to our business that may be considered forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties including the risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2015 as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You were cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time they were made. All forward-looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update any forward-looking statements. Now, I’ll turn the call over to Scott Salka, CEO of AmpliPhi Biosciences.

Scott Salka

Management

Thank you, Matt. With me on the call is Steve Martin, our CFO. We will begin the call by providing an overview of 2015 and recent highlights, followed by our fiscal year 2015 financial results. We will then take your questions. 2015 was a very productive year for AmpliPhi. And in the first quarter of 2016 we continued building on that success. So I’d like to start by highlighting key 2015 accomplishments. We completed a $13 million private placement of common stock in March of 2015 that was a key step on the path to advancing our product candidates. Following the fundraising, we received a European patent for a bacteriophage therapy designed to fight biofilm related bacterial infections. The patent claims protect certain aspects of the company’s AB-PA01 program, proprietary mixture of bacteriophage targeting Pseudomonas infections in the lungs of patients with cystic fibrosis. In the second quarter, AmpliPhi made significant progress towards achieving our near and longer term clinical and commercial objectives when we receive cGMP manufacturing clearance for a facility in Slovenia. In August, following our successful reverse stock split, we listed the company on the New York Stock Exchange market and started trading under our current ticker APHB. This was a key milestone that both strengthen our ability to fund development of our programs, as well as position us as the publically-traded late leader in bacteriophage therapy. In September, we presented positive data, demonstrating that the efficacy of our prototype bacteriophage cocktail is comparable to Vancomycin, a standard-of-care antibiotic for treating Staph aureus lung infections. Staph has demonstrated widespread resistance to traditional antibacterial agents and there is an urgent and growing need for novel treatments. In November, we signed a clinical trial agreement with the University of Adelaide and the Queen Elizabeth Hospital in Adelaide to conduct…

Operator

Operator

[Operator Instructions] And we’ll take our first question from Keith Markey with Griffin Securities. Please go ahead. Your line is open.

Keith Markey

Analyst

Hi, Scott. Hi, Steve. A couple of questions, I was just wondering if you might elaborate a little bit on the relationship that you have with the Westmead Institute Center for Infectious Diseases and Microbiology.

Scott Salka

Management

Sure, Keith. Thank you. So the Westmead is a research institute in Australia and you’re referring to the government grant that we got in conjunction with Westmead from the Australian government. That grant totals just under US$900,000. That work will be spearheaded by the Westmead. We’ll provide certain phage expertise and phage capabilities. And it’s targeting the development of phage that can target infections, E. coli and Klebsiella infections.

Keith Markey

Analyst

Okay. Thanks. And then, what is the status enrollment in your Staph trial with the University of Adelaide?

Scott Salka

Management

Again, Keith, thanks for the question. So we - as we stated, we initiated enrollment in that study in January of this year. And we expect to complete the enrollment around the middle part of the year. So I can say that we are on target for doing so. We’re excited about the fact that we’re screening patients, we’re finding - there is no shortage of patients that are eligible for the study. And so it’s just a matter of getting those patients do the study and dosed. And so, we expect to complete that study middle part of the year.

Keith Markey

Analyst

Great. And then, can you just give us a brief update on the collaboration with the U.S. Army?

Scott Salka

Management

Absolutely, Keith, so as you know, we had this collaboration with the U.S. Army for a while. It’s a wonderful relationship that we’ve developed with them. We expect - as we’ve already stated this year, we expect to initiate our second clinical study with the U.S. Army that will happen shortly. And we expect to fully enroll that Phase I clinical study in the first-half of 2016. That is a study initially focused on applying Staph aureus phage to the skin of healthy volunteers to assess the safety of that phage preparation.

Keith Markey

Analyst

Great. I’ll go back in the queue. Thank you.

Scott Salka

Management

Thanks, Keith.

Operator

Operator

Thank you. [Operator Instructions] We’ll go ahead and take our next question from David Bautz with Zacks Investment Research. Please go ahead. Your line is open.

David Bautz

Analyst · Zacks Investment Research. Please go ahead. Your line is open.

Hey, guys, how are you doing today?

Scott Salka

Management

Hi, how are you doing? Thanks for participating in the call, appreciate it.

David Bautz

Analyst · Zacks Investment Research. Please go ahead. Your line is open.

Sure thing, I just have a couple questions. The first one is could you elaborate a little bit more on what was acquired in the Novolytics acquisition? I mean was there products that could eventually end up in the pipeline or maybe if you could expand upon that a little bit more?

Scott Salka

Management

A great question and I don’t anticipate that there is a product that will come from that acquisition. What we did get was a library of phages. So those phages will certainly be added to the libraries of phage that we screen against important pathogens. We also got certain know-how from that Novolytics acquisition. And that know-how includes experiences with the regulatory agencies in the UK. There is really important formulation know-how. Novolytics had been working on a topical application of phage, so it is a gel type of an application. So we got that type of information as well form Novolytics.

David Bautz

Analyst · Zacks Investment Research. Please go ahead. Your line is open.

Okay. Thanks for that. And my last one is, so I know the sinusitis study that’s currently ongoing is primarily a safety study, but I was wondering if you could talk a little bit about what you might consider a success when you’re looking at some of the secondary endpoints.

Scott Salka

Management

Great question. So, yes, as you pointed out, this is primarily a safety study. It’s an open-label study, so both the patients and physicians know that everybody is getting treated with the phage. But what we are looking at is, from a qualitative standpoint we’re looking at the infection and assessing the infection prior to dosing and post-dosing, so that includes pictures taken of the infected area and assessment made by the surgeon who is looking via an endoscope into the - deep into the sinuses of the patient to characterize the extent of the infection. We’re also swabbing that active side of infection; culturing, making sure that the infection is Staph and then we can somewhat quantify that infection prior to and post dosing because, again, we take the culture prior to the patient being dosed by the phage, after the patient being dosed by the phage. So it is a safety study. We primarily want to ensure that we can safely deliver the phage operation to the patients without any adverse events. But certainly we would like to see some directional improvement in the infection.

David Bautz

Analyst · Zacks Investment Research. Please go ahead. Your line is open.

Okay. Thanks for taking my questions.

Scott Salka

Management

Thank you very much, David.

Operator

Operator

Thank you. [Operator Instructions] And it does appear we have no further questions at this time. I will now hand the program back over to Scott Salka for any additional or closing remarks.

Scott Salka

Management

Thank you very much, Tanisha. So in summary we have a busy and very exciting year ahead as we continue our Phase I clinical trial and advance our product development efforts. Thank you so much for joining us today and have a pleasant day.

Operator

Operator

And that does conclude today’s program. We like to thank you for your participation. Have a wonderful day.