Earnings Labs

Phio Pharmaceuticals Corp. (PHIO)

Q2 2016 Earnings Call· Fri, Aug 12, 2016

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Transcript

Operator

Operator

Good afternoon ladies and gentlemen, and welcome to the RXi Pharmaceuticals’ Second Quarter 2016 Earnings Conference Call. Today’s call is being recorded. At this time, I would like to turn the floor over to Ms. Tamara McGrillen, Head of Investor Relations for RXi. Ma’am, the floor is yours.

Tamara McGrillen

Management

Thank you, Operator. Good afternoon ladies and gentlemen and thank you for participating on our call today. We are joined today by our President and CEO, Dr. Geert Cauwenbergh; our Chief Development Officer, Dr. Pamela Pavco; and our Principal Accounting Officer, Ms. Caitlin Kontulis. I would like to remind listeners that this call will contain certain statements concerning RXi’s future expectations, plans, and processes which constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements and as a result of various important factors including those discussed in our most recent Form 10-Q filed today with the SEC. In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. Now, I would like to turn the call over to our President and CEO, Dr. Cauwenbergh.

Geert Cauwenbergh

Management

Thank you, Tammie, and thank you all for being on the call this afternoon. To put this update call in perspective, I want to remind you of the key milestones we outlined in our presentation to you on Monday, January 11 of this year, during the Biotech Showcase Meeting in San Francisco. For those who want to look at it, I’m referring to the slide number 32 of our corporate presentation from that date. We wanted this quarterly update to serve as a mid-year status check for what we have achieved against those goals to-date. And I will follow in discussion to the sequence of the slide. First, to begin with our dermal program, we remain on track to meet all of our stated goals as outlined in January. We committed to be fully enrolled with our topical immunotherapy compound Samcyprone by the end of the year. We have worked hard to uphold that promise. To-date we have improved our formulation to the point that we will be able to move for the next studies of the compounding pharmacies to a CGMP facility that can produce large quantities of medication. I’m proud to say that this has allowed us to further strengthen our patent position proud [indiscernible] and that we have now four clinical sites online that has significantly ramped up recruitment for this Samcyprone 1502 Study in cutaneous warts. Bottom line we are on track to fulfill our promise to have this Study fully enrolled by the end of 2016 and have a first readout on the efficacy of Samcyprone in cutaneous warts for a relevant subset of the patient population. In addition, some dermatology companies have expressed an interest in talking to us about the potential license once the Phase II data would be comparable and would indicate…

Caitlin Kontulis

Management

Thank you, Geert, and good afternoon everyone. As reported today the Company had net revenue of $900,000 for the three months ended June 30, 2016 as compared to no revenue for the same period of the prior year. The net revenues during the quarter was due to common stock and warrants issued to RXI by Thera Neuropharma as per the terms of the exclusive licensing agreement between the two companies executed in May of this year. Research and development expenses were $1.34 million for the quarter ended June 30, 2016 compared with $1.36 million for the quarter ended June 30, 2015. This increase of approximately $20,000 was primarily related to a decrease in stock based compensation expense due to the full vesting of stock options that were granted in 2012 offset by an increase in research and development expenses related to manufacturing cost for Samcyprone and clinical trial fees for Study 1502 the Company’s warts trial that commenced in December 2015. General and administrative expenses were $0.88 million for the quarter ended June 30, 2016 as compared with $0.8 million for the quarter ended June 30, 2015. The increase of $80,000 was due to an increase in general and administrative expenses primarily related to legal and proxy related fees for the Company’s special meeting in reverse stock split in April. And from the use of professional service providers due to the Company’s focus on business development activities offset by a decrease in stock based compensation expense as a result of the full vesting of stock options that were granted in 2012. Net loss of $2.2 million for the quarter ended June 30, 2016 compared to $2.2 million for the same period of the prior year. Overall, net loss was consistent year-over-year with fluctuations in operating expenses as just discussed. Net…

Pamela Pavco

Management

Thank you, Caitlin, and hello everyone. In the three months since our last earnings call. We have made quite a bit of progress and continue to stay in line with all of our year-end research and development goals. From the clinical development side, we are on track or head of all of our initial internal enrollment goals. This was all four cohort in our dermal scarring trial with RXI-109 Study 1402 will be completely enrolled and dates for scar revision surgery set. Our goal is to enroll by the end of this year, so we are about four months ahead of schedule. Knowing the timing for the last person enter in this trail and receive their scar revision surgery and that the last data point is that nine months allows us to better predict the availability of data for interim and final reviews. Assuming all revision surgeries will be scheduled and completed by mid September, the last 1402 subjects nine months as it will occur in mid-June 2017. Our plan however is to do preliminary internal review of a subset of data from cohorts three and four before the end of the year. As of today, we have 11 subjects that have already reached three months and these subjects will reach seven months in December of 2016. So at the end of this year, we will be able to provide an interim review of the safety data and the preliminary clinical activity for these initial subjects and cohort three and four. In addition, all subject cohort one and two will have reached their nine months visit before the end of the year. Our goal is to complete data entry into our data based for these subjects and provide a summary overview of the first two cohorts at the same time.…

Tamara McGrillen

Management

Thank you, Pam. This now concludes the formal presentation for today and operator we would like to pull for questions please.

Operator

Operator

One moment. Okay. Thank you. The call is now open for questions. [Operator Instructions]. And our first question comes from [Keith Markey] (Ph). Please state question.

Unidentified Analyst

Analyst

Good afternoon. One question I had is when do you think or how long do you think the consumer application or trial of the tyrosinase product will take? And how long will due process takes sort of overall how long will it take for you to actually potentially get into the market with this product?

Geert Cauwenbergh

Management

Right. So the test that Pam described is standard test that is also being used for sunscreens, so it's how you test the SPF of sunscreens and in this case of course we are not interested in protection against sun rays, we are interested in the effects of rays of the melanocytes and melanin production. That’s a standard test, so you basically recruit volunteers, you can take surgeons or whoever you want to take as volunteer for this. It is much more streamlined than a clinical trials, so it will be relatively quickly. I think that we can have this done in something like I would guess six months from the moment that we started until the readout.

Unidentified Analyst

Analyst

Great and is the review process inside the FDA for it to be very long, do you think after you get the task completed?

Geert Cauwenbergh

Management

There is no review process by the FDA, that’s the nice thing with the functional skin care. In functional skin care consumer products you don’t need FDA approval you just cannot make therapeutic claims. Of course, what does happen is when we show with our functional skin care product RXI-231 that it works in the hyperpigmentation then the lead into taking an analog for drug development for proper term drug development is an easy one. We will have our proof-of-concept for the drug by doing the consumer testing.

Unidentified Analyst

Analyst

Right. So do you anticipate being able to get a partner based upon the sunscreen test itself and possibly see get it into the market fairly soon?

Geert Cauwenbergh

Management

The number of the companies that are into that space including some of the larger multinationals that are into the consumer space and are interested in pigmentation and management of pigmentation in people have expressed an interest in talking to us when we have those data available.

Unidentified Analyst

Analyst

Terrific. And then another question on the 1502 clinical trials, I was just wondering when is that readout going to take place?

Pamela Pavco

Management

So we will enroll everyone by the end of this year for sure. And if everyone sensitizes properly and gets 10 weeks of treatment, the last treatment is 12 weeks from the end of the year. So, we are hoping that maybe we will be able to reduce the number of doses et cetera, but it will be sometime in the probably by the second quarter that we have the full set of data compiled into database and that kind of thing.

Unidentified Analyst

Analyst

Similar question for…

Pamela Pavco

Management

The ophthalmology trial?

Unidentified Analyst

Analyst

Yes, the ophthalmology, thank you.

Pamela Pavco

Management

So kind of the same thing. That one we are assured of having five subjects, we have five now, we need to enter four more subjects. Given that we are kind of ahead of schedule we are hoping that we will be able to do that by December or January. But that is not given. And then the endpoint is seven months from them. So presumably, we will be into the later part of 2017 August or September by the time we are finishing up the trial and then of course we need some time to complete the data basin and lock it, before we can have the full side of data. But obviously along the way, we will be reporting on safety and any preliminary efficacy endpoints that concern to the gap.

Unidentified Analyst

Analyst

That looks like you are going to have a lot of very interesting data coming out next year. Congratulations and thank you.

Pamela Pavco

Management

Thank you.

Operator

Operator

Our next question comes from [Max Jacobs] (Ph). Please state your question.

Unidentified Analyst

Analyst

Hi, everyone and thanks for taking my question. So I was just wondering, if you can expand on what where the enrollment issues related to the Samcyprone trial. Was it just alternative therapies or was it just the fact that it was only one site?

Pamela Pavco

Management

So there were couple of issues. One was that, while we open the trial, we were still refining the formulation and having it made. So that was one bit of a delay right at the beginning. The initial site was slow to recruit and we are not quite sure why. Because the other three sites almost immediately were able to enroll quite rapidly. So it was somewhat of a some issue start.

Unidentified Analyst

Analyst

Okay, great. It’s in terms of like the new formulation. I mean, if you are still kind of or you are in the process of until recently optimizing it. Does that mean, you haven’t filed the patent application on it yet?

Geert Cauwenbergh

Management

We are filed in provisional, which allows us, within a year to finalize it. So there is a provisional factor has been filed and that includes formulation, as well as additional indications.

Unidentified Analyst

Analyst

Great. And so potentially you could go to like 20, 30 sets in terms of production?

Geert Cauwenbergh

Management

The four dose patents yes. Probably minus three is in the U.S., because usually patent [life] (Ph) in the U.S. is only 17 years depending on what approach you choose.

Unidentified Analyst

Analyst

Okay. And then I was just wondering in terms of the strategic review. From your comments, it sounds like, it’s mostly kind of you are looking at company’s purchase kind of, it’s merge with RXI. Is that the case or you also looking at potential sales of company?

Geert Cauwenbergh

Management

So you never going to exclude the sale for simple reason that somebody wants to purchase has the control over debt they basically said you know whether or something like that. We are not actively pursuing the sale of the company, if that is your question and as well that is my answer. We are focusing on more strategic partnerships, but definitely mergers are at the top of our agenda.

Unidentified Analyst

Analyst

Okay. Great. Yes. That’s all my questions. Thank you very much.

Pamela Pavco

Management

Thank you.

Geert Cauwenbergh

Management

Thank you.

Operator

Operator

And our next question comes from [Carol Werther] (Ph). Please state your question.

Unidentified Analyst

Analyst

So I just wondered if you could just give me a little bit more information about how you plan to do some of the financing going forward. I mean your planning came in less than I expected this quarter. But if you could help me with that I would appreciate it.

Geert Cauwenbergh

Management

Well, there is a number of possibilities, Caitlin already elucidated to the fact that we have an equity line. We have received signals from the [indiscernible] and another firms that they would be rolling to extend that equity line if we want to do it at under pretty much the same circumstances or pretty much to say the same conditions, which is in my opinion good news, because the condition for that equity were good in our opinion. There is the possibility of a financing, so ideally we would like to do that in conjunction with a corporate transaction. So that people see the value from the corporate transactions and that there is not just a reason for we need more money but there is a good reason for the doing to financing. And the nature of the financing could be whatever is available like conventional price, although that’s non [indiscernible] approach. Right sort of offerings can be of interest, because then it shows appreciation and respect for our current shareholders who will be able, all of them not just a few of them, to participate in a financing if that is what they want to do.

Unidentified Analyst

Analyst

And then just about how - you have a lot of data readouts coming up. And should I be looking for press releases or are you targeting some medical meetings where things could be presented?

Geert Cauwenbergh

Management

Well, I could leave that to Tammy, but usually what we do is when there is news and we press release it, if it disclose to a medical meeting and we try to be see that so that the press release and the medical meeting goes sort of hand-in-hand.

Unidentified Analyst

Analyst

Thank you.

Pamela Pavco

Management

Sure.

Geert Cauwenbergh

Management

Thank you very much.

Operator

Operator

And there appears to be no more questions at this time.

Tamara McGrillen

Management

Well, thank you everyone for participating on our call today. And operator, we may end the call.