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Phio Pharmaceuticals Corp. (PHIO)

Q3 2015 Earnings Call· Thu, Nov 12, 2015

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen and welcome to RXi Pharmaceuticals’ third quarter 2015 earnings conference call. Today's call is being recorded. At this time, I'd like to turn the call 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 and thank you for joining us today. We are joined today by our President and CEO, Dr. Geert Cauwenbergh; our Chief Development Officer, Dr. Pamela Pavco and by 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 prospects which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Litigation Reform Act of 1995. Actual may differ materially from those indicated by these forward-looking statements and as a results of various important factors including those discussed in our most recent Form 10Q filed today with the SEC. In addition any forward-looking statements represent our views only as of today 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 estimates and expectations. For a detailed list of risk factors that may impact the company's estimates, please refer to the news releases and RXi Pharmaceuticals' SEC filings. Now, I'd like to turn the call over to Dr. Cauwenbergh.

Geert Cauwenbergh

Management

Thank you, Tammy. Good afternoon to everybody. I appreciate you all for joining the call today. Before turning it over to our management team. I want to highlight what word key defining events were exciting in the third quarter and since the end of the quarter. On the product development from we have provided three month medical results with RXI-109 versus control for our first two cohorts in the RXI-109 1402 study to reduce the recurrence of hypertrophic scars at the scar revision surgery. Dr. Pavco will provide a more detailed information but the bottom line is that direct clinical assessments of the patients by the treating physicians as well as blinded panel and investigator reviews of all treatment pictures of the incision areas of these patients have shown statistically significant differences in favor of our RX-109 treatment as compared to control. We announced that we initiated our first trial in pomology with RXI-109 to prevent the progression of retinal scaring, a harmful component of numerous retinal diseases. This phase 1/2 study is in patients with advanced macular degeneration who show a scarring component as a result of the disease progression. We have also made good progress on the intellectual property front with several patents being issued relating to our RNA platform both in the U.S. and abroad. We are also working on new submissions focusing on strengthening our IP position for Samcyprone, our collaboration with Biogazelle in Belgium has led to an exciting discovery for our RXi RNA As it was generally believed RNAs were only capable of affecting RNA [indiscernible] this collaborative research as demonstrated that surprisingly our as the RX RNA compounds are also capable of significantly that means more than 60% reducing long non-coding RNA in the cell nucleus. Apart from that being a remarkable biological…

Caitlin Kontulis

Management

Thank you, Geert and good afternoon everyone. As we reported today total operating expenses for the third quarter of was 2.5 million compared to 2.2 million for the third quarter of 2014. The increase of about $300,000 or 13% from the prior year period was primarily driven by research and development expenses. Research and development expenses for the three months ended September 30, 2015 were $1.7 million compared with $1.5 million for the three months ended September 30, 2014. The increase in R&D expenses was primarily driven by a new drug manufacture of our RXI-109 that commenced earlier in the third quarter of this year offset by a reduction in expenses related to the 1301 and 1401 clinical trials as these come to completion. General and administrative expenses the other component of operating expenses for the three months ended September 30, 2015 were 770,000 compared with $766,000 for the three months ended September 30, 2014. G&A expenses for the third quarter of 2015 were consistent with the G&A expense as for the third quarter of 2014. Net loss applicable to comment stockholders was $2.5 million for the quarter ended September 30, 2015 compared with $2.9 million for the quarter ended September 30, 2014. The decrease of about $400,000 or 14% from the prior year period was primarily driven by the reduction in the preferred chair dividend offset by the increase in research and development expenses as previously discussed. There were no dividends paid on the Series A and Series A1 preferred stock during the three months ended September 30 2015 as compared with the same period in the prior year as all outstanding shares of both series were converted into common stock on May 27, 2015 as a result there are no shares of the Series A and Series A1…

Pamela Pavco

Management

Thank you Caitlin and hello everyone. The R&D group said been extremely productive in the last few months. On the call today I will first update you on the advancements we have made in our [Technical Difficulty] dermal and ocular programs and then fill you in on where we are with our first trial evaluating Samcyprone, our immunotherapy therapy compound. Lastly I will touch on some of our most recent progress in the search area. As you may know we recently announced the three month results of study 1402 in hypertrophic scarring. In this ongoing study we are comparing two dose levels of our RXI109 for the ability to reduce the recurrence of hypertrophic scars after scar revision surgery. We have completed in a moment in the first two cohorts of this study and evaluated the results at three months for 15 subjects, after scar revision surgery each subject has a least two centimeters of their scar treated with your RXI109 either 5 or 10 per centimeter and a any similar length of the revised area is left untreated for comparison. This allows us to directly compare the outcome of treatment with RXI109 versus no treatment on the same person. At the time of the evaluation these subject had received five of their six doses in the planned dosing regimens. We use several methods for this comparison. First the investigator used two standard assessment scales directly score each revised area on the subject in their care. One was called the patient and observer scar assessment scale or POSAS which allows the investigator to assess the characteristics of a scar for example how red it appears and whether or not it's raised above the skin level or flat. The second was a VAS or visual analog scale on which the investigator…

Geert Cauwenbergh

Management

Thank you, Pam. Since RXI began operations in April 2012 the company has delivered against of it's projected milestones on time and even under budget. Moreover RXI has had an excellent third quarter also this year. Based on expected news flow we feel confident that this trend may continue. I would be remiss not to mention the headwinds that in the last several months have a affected healthcare and biotech in general and small biotech in particular. Although there is a broader need and expectation from the public to see new drugs developed and come to market to improve the lives of millions of patients the responsible acts of some companies and individuals as well as a [indiscernible] has affected many companies in our industry including our company. The investment world is understandably focused in the first place on making money for themselves and for their clients and in a client of uncertainty you will get that effect the confidence with which investments are made and sustained. I'm confident that over time common sense will prevail and companies with strong technology platforms and clear capabilities to other people based on potentially transformational innovation will try. I continue to consider RXI Pharmaceuticals as one of those companies and as a result expect our initiatives and their outcome to contribute to announce shareholder value and now back to Tamara McGrillen.

Tamara McGrillen

Management

Thank you, Geert. This now concludes the formal presentation for today. Operator we would like to now pull for questions at this time please.

Operator

Operator

[Operator Instructions]. The next question comes from Mark.

Unidentified Analyst

Analyst

This is actually Matt on for Mark, thanks for taking the question. Maybe if you could get us sense where you think [indiscernible] paradigm are we thinking maybe a second line to the anti-VEGF therapies or maybe at some point would you consider exploring them in combination with each other?

Pamela Pavco

Management

I think the combination idea is a very, very interesting one. At the moment more than half of folks under treatment with anti-VEGF therapy develop scars within two years or at least by the time they reach two years. So one thing we have to sort of try to figure out is it better to wait and start midway through their anti-VEGF treatment or go ahead and start from the very beginning. So one option for us is to do use this is assuming everything goes well in our trials to use our RXI,109 with the current anti-VEGF therapies that are out there. We also have an anti-VEGF [indiscernible] RNA that we might consider taking for together with RXI109.

Unidentified Analyst

Analyst

And my next question is there a means that we can measure retinal scarring that [Technical Difficulty].

Pamela Pavco

Management

There is actually some -- so what we will be doing optical coherent stenography [ph] as well as battery of standard visualizations and taking photographs on things like the photography. You can't measure the back or look at the back of the eye and see and measure how much scar is there and see whether it's progressing during the course of this trial which is what we hope to prevent from happening. Obviously you can't use a placebo -- if the patient also has scars in their other eye we can measure follow that other eye as well and we may see a difference between the progression of the scar and the eye that’s not treated compared to the one that is treated that's one possibility for getting some information on clinical activity out of this first trial.

Unidentified Analyst

Analyst

Last question if we can shift to the pharmaceutical, is this a program that you would intend to developing -- [Technical Difficulty] .

Geert Cauwenbergh

Management

That’s a very good question. The last thing we want to do is to go too broad with our activities. We received a request to being able to do cosmetically work from few players in the space. So our intention is to bring it up to a certain point and while we are doing that negotiating with those potential partners to see if we can come to a collaboration so that those potential partners would take some of the word out of our hands at the same time that would allow us to look other compounds in that area because we have multiple candidates that we could look at for development in drugs but separate from the cosmeceutical ones.

Operator

Operator

Your next question comes from Katherine. Go ahead, Katherine you’re live.

Unidentified Analyst

Analyst

I had a couple of questions, the first was on the RXI109, the 1402 study, in regards to the additional cohort. I was just wondering what colors are what caused or what gave you reason to go on to the additional cohort or going for specific 8 or 9 treatments or is there something that you saw in the initial cohorts or just the decision to just elongate and try to get a little bit more efficacy over the six month period?

Pamela Pavco

Management

Well even at the beginning of the study we knew that the time course for hypertrophic scar formation can last over a two year so when we were treating only for the first three months we were really only treating at that very initial time and we are seeing that there is a difference between being treated and the untreated at three months after in this case it was after five doses at that first three month period. However we believe that if we treat for a longer out further from three to six months we will even have a better response and the treated will be even more resemble normal skin rather than having any remnants of hypertrophic scarring. The other reason to continue treating is if we continue treating farther into that hypertrophic or proliferation phase of scarring we may dampen down the potential recurrence between for example three months and six months. So in some cases people that are especially people that are really prone to hypertrophic scarring even if you were to treat for three months. They may begin to get a -- their scar may begin to come back. So our thoughts on this were to treat for a longer period of time for especially for these people that have that that are in these trials with serious hypertrophic scarring issues and that might not only help them keep the scar from coming back during the treatment but prolong the affect so that it doesn't come back after the treatment is stopped.

Unidentified Analyst

Analyst

So you'll presumably have a number of readout the initial six months and then follow up readout maybe--

Pamela Pavco

Management

Absolutely. We’re actually are going to make our first read out at seven months official readout because that's one month after the last treatment that will be received by the subjects in either cohort three or four with either in eight or nine doses and then they're followed up to nine months so we'll have another readout at nine months as well.

Unidentified Analyst

Analyst

And then I just had a question on Samcyprone well. I'm just wondering if you could give us an idea of the age group that you're looking at for your Phase 2 face for cutaneous warts and then it looks like it's a relatively quick trial with just the ten weeks if you'll be evaluating as you go on at the ten week so I'm wondering in terms of data if we can expect data to have 2016 on that?

Pamela Pavco

Management

Sure. So we are starting this trial with in an adult population. While a DPCP in acetone and various formulations have been used in children. We want to establish a nice safety profile in adults before we were before we would move into children. So it's going to be 18 and up. That does slow down the recruitment just a little bit because obviously the children, the pediatric population has more warts than the older population. But we felt that was important just to go through the safety portion of this trial first.\ Having said that we expect to be able to rope in fully enroll this trial next year by the end of the here and so with the a sensitization period of time and a 10 week treatment period if we enroll by the end of the year we should be able to have a database lock and be able to look at all the patients by mid-year in 2017.

Operator

Operator

Our next question comes from Kenneth. Go ahead, Kenneth you’re live.

Unidentified Analyst

Analyst

I'm just interested more about the timeframe on this skin lightening franchise how you expect that to progress and what we could expect to see him terms of a timetable for bringing that product hopefully successfully out to market?

Geert Cauwenbergh

Management

Well. You can imagine cosmetics or being developed or cosmeceutical are being developed totally differently from drugs, since cosmetics and cosmeceuticals are not intended to treat or prevent diseases but are used to manipulate the appearance of the skin, regulations are different, that means more specifically and importantly that that for cosmeceutical you can only do in vitro work, no animal data before you move into humans. And so then you basically go to the groups of individuals who are unhappy with their skin tone, texture or pigmentation. And you evaluate the application of the product on their skin to see affects those features. You can do that objectively by specific methods that have been developed and are widely used in academic centers, you can use chronometers to look at the degree of pigmentation. You can use [indiscernible] measurements on the skin to see how it changes over time and that is something you don’t do immediately on humans. So the development of cosmeceuticals as a result should go a lot faster. At the same time and that is already what we have done in vitro. We have seen over the phenotypic change meaning visual effects in the in vitro testing that make us optimistic that if we can provide the product topically to the point that it reaches the lower layers of the epidermis that we hope to see their effect as well. There is what Dr. Pavco mentioned that one of our key activities today is to see to what extent we can accelerate, improve absorption in the skin, not through the skin in the blood but in the skin in order to optimize the effect.

Operator

Operator

There are no further questions.

Tamara McGrillen

Management

Okay. Ladies and gentlemen thank you very much for participating in our call today. And this concludes our call.