Earnings Labs

Phio Pharmaceuticals Corp. (PHIO)

Q4 2015 Earnings Call· Wed, Mar 30, 2016

$1.21

-0.02%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+1.12%

1 Week

+1.12%

1 Month

-16.85%

vs S&P

-17.00%

Transcript

Operator

Operator

Good afternoon, ladies and gentlemen, and welcome to RXi Pharmaceuticals Fourth Quarter and Year-End 2015 Earnings Conference Call. Today’s call is being recorded. At this time, I’d 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. 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 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-K 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 good morning and good afternoon to everybody. Our team continued to work diligently in 2015 and once again successfully executed against its projected corporate goals. In the first half of 2015 our share price was continuously challenged with a conversion of preferred shares and selling of those converted equities in the open market. Despite the positive data generation that was produced by our R&D engine to work throughout the year. The final thing that we completed in June of 2015 has provided our company with the necessary cash to continue our executional success for R&D into 2016. As a result of this in the second half of 2015 we successfully initiated two clinical studies and continued further treatment length testing in study, first of all a two cohort extension to study 1402. After defining the right timing to start treatment with our anti-scaring compound RXI-109, that is two weeks after scar revision surgery, we have been able to confirm efficacy versus placebo in prevention of the returns of hypertrophic scars. And we have been able to identify our best dose moving forward, 5 milligrams per centimeter of incision length. And the two new cohorts that we added to the 1402 study, we are building them on the direction [ph] are exploring six month treatment regimens to evaluate if we are able to maintain a clinically significant difference between the treated portion of the revised scar and the controlled side of the scar in the same patient for a period of nine months after the scar surgery. The study is enrolling well and we expect to provide updates on this study in the latter part of 2016. The second and third clinical study, the Phase 1/2 study has been initiated with RXI-109 in the eye for treatment…

Caitlin Kontulis

Management

Thank you, Geert and good afternoon everyone. The company's annual report on Form 10-K was filed with the SEC and includes detailed information on the company's financial performance in 2015. During the call today I will focus on selected financial highlights. Total operating expenses increased during the fourth quarter of 2015 and for the year-ended 2015 as compared with the same periods in the prior year mainly due to increases in research and development expense. Research and development expense for the quarter-ended December 31, 2015 was $1.7 million as compared with $1.6 million for the quarter-ended December 31, 2014. Research and development expense for the year-ended December 31, 2015 was $6.9 million as compared with $5.7 million for the year ended December 31, 2014. The increase in research and development expense quarter-over-quarter and year-over-year was primarily due to manufacturing expense for RXI-109 and Samcyprone drug product for use in the company's clinical trials. Additionally research and development expense increased due to a modest increase in headcount and for lab supplies and materials used as the company moves forward in the development of our cosmetic targets and topical delivery applications. General and administrative expense for the quarter ended December 31, 2015 was $0.9 million as compared with $0.8 million for the quarter ended December 31, 2014. General and administrative expense for the year-ended December 31, 2015 was $3.3 million as compared with $3.2 million for the year-ended December 31, 2014. The increase in general and administrative expense quarter-over-quarter and year-over-year was primarily due to an increase in compensation expense as well as an increase in professional services expense due to the company's continued and increased focus on business development activities as one of our key corporate initiatives that we announced last year. These increases led to both an increase in the…

Pamela Pavco

Management

Thank you Caitlin and hello everyone. As Geert has already mentioned, our research and development groups have been quite busy. Today I’ll summarize this work for you starting with a little information about each of the trials that we initiated in the fourth quarter of 2015 and end with a discussion of our research efforts, cosmetic product development, and the directions that we are taking there. As you know our lead sd-rxRNA program is evaluating RXI-101 to prevent post surgical dermal scaring by reducing connected tissue growth factor or CTGF. In this series of trials we have been continually building our knowledge of the therapeutic action of RXI-109 as we successively and systematically alter the dose and dosing regimen to optimize therapy. In the previous study studies 1301 we have learnt that initiating treatment at two weeks after scar revision surgery seemed more effective than beginning the dosing regimen on the day of surgery. In the first two cohorts of the current study, study 1402, we compared two dose levels 5 milligrams and 10 milligrams per centimetre of incision length using a dosing regimen starting at two weeks after the scar revision surgery and continuing with a total six doses over the course of three months. In this study, one or two hypertrophic scars are revised and part of the resulting incision is treated with RXI-109 and another part is left untreated. As reported in our November 2015 earnings call, based on the three month photographic and scar assessment data we learned that regardless of dose level of RXI-109, the treated scar was selected as the better appearing scar approximately 65% of the time and an additional 19% of the time there was no difference between treated and untreated. In addition safety assessments for the 5 milligram and the 10…

Geert Cauwenbergh

Management

Okay, thank you Pam. At this time I would like to thank you for your interest in and continued support of RXi Pharmaceuticals. Our team remains dedicated to continuing the positive momentum we have generated in our clinical and research development programs and we look forward to building up on those successes during 2016 working towards the development of novel therapeutics to improve patient’s lives and now back to Ms. McGrillen

Tamara McGrillen

Management

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

Operator

Operator

[Operator Instructions]. And the first question comes from Keith Markey. Keith, please state your question.

Zachary Ajzenman

Analyst

Hi, thanks good evening this is Zack Ajzenman in for Keith, can you maybe provide us with the status of your business development efforts?

Geert Cauwenbergh

Management

Yes, well we have seen I think recently an increased trend towards actually away from IPOs and reach out to public companies by private companies to reacquire it become public. Because of the deplorable state of the IPO market for biotech companies the Wall Street Journal of November 30, 2015 mentioned something like forget IPOs if you want to get – and that seems to become a reality and that can open the door to interesting deal making for public companies like RXi that have exciting pipeline in technology platform with an excellent IP protection. So we are exploring a number of opportunities there. We are hopeful that we can communicate additional information on these in the coming months but it was currently not in the interest of the company or the potential partners we are talking to who will provide additional information. But trust me that we are actively working very hard to achieve the best possible solution for our shareholders.

Zachary Ajzenman

Analyst

Thanks that’s all for us.

Operator

Operator

And our next question comes from Mark Breidenbach. Please state your comment.

Mark Breidenbach

Analyst

It was pretty close, Breidenbach is the last name. Hi guys, congrats on the fourth clinical progress on multiple fronts and just a couple of questions this afternoon. With respect to RXI-109 in dermal scarring, if I heard correctly we have two new cohorts that should be fully enrolled by the end of this year, maybe perhaps even a little sooner than that and we might see a readout on those cohorts in early 2017. How confident are you that the six month extended dose schedule will kind of achieve, is really going to be fully optimized. I guess the question is, are there any specific signals you are looking on the data to declare the dosing schedule fully optimized?

Pamela Pavco

Management

That’s a really good question because the course of scar formation can be so long. What I think we believe now is that six months will give a great basis for tamping down the scar formation over the primary part of that proliferation phase when the collagen is being laid down. And it is possible that the whole course of treatment may also include maintenance doses where a person comes back to the doctor over the course of a longer period of time after the six months even. If the scar begins to show or their wound area begins to show signs of continuing their scar formation. And if you’ve ever had a scar, when it’s forming it is sort of itchy and there could be some signs that bring the person back to the doctor to continue treatment. But since the hypertrophic scar nine months is kind of -- by then it is starting to wind down. It can go on longer but that is sort of typical. We do think that six months ought to be a really good basis for this trial to determine if we can just hold off the scar formation. We’ll look at nine months after the six months of treatment and we may be able to determine if it has held steady or if it is beginning to come back and that could help gauge whether we need to continue treatment as well.

Mark Breidenbach

Analyst

Okay, understood and my final question really goes back to some interesting data you presented in the fourth quarter using sd-rxRNA to modulate link RNAs and I don’t think we heard much about it on the call today. But can you offer me thoughts on which indications or indication areas that you see as most amenable to address by targeting link RNAs?

Geert Cauwenbergh

Management

Well, the alumnus [ph] quoting RNAs are a totally different observation that was done last quarter I think of last year. It was done in collaboration with a group in Belgium and we are exploring or they are exploring further what can be done with them. Many of those long known coding RNAs are more responsible for phenotypic changes that can occur during diseases processes. So it provides for potential opportunities going forward to explore their role and how we can affect phenotypic expressions in certain diseases. But it is still early day today in terms of making any projections even going into clinical studies or something like that. It is just a fascinating space that has actually quadrupled whenever staff gets that weekend addressed with our typical and proprietary sales delivering rxRNAs.

Mark Breidenbach

Analyst

Okay, fair enough. Thanks for taking the questions and good luck.

Geert Cauwenbergh

Management

Thank you.

Operator

Operator

And our next question comes from Catherine Janice [ph]. Please state your question.

Unidentified Analyst

Analyst

Yes, good afternoon everybody and thanks so much [Technical Difficulty] RXI-231 and RXI-185, I am wondering if you could just walk us through the accelerated development plan hitting on a couple of the key milestones as you work towards your potential launch at the end of the decade and also when you speak of a market potential of 200 billion, it is a very large number. I am just wondering if it is possible to narrow that market down a little bit from there for us? Thanks.

Geert Cauwenbergh

Management

Right, so maybe I’ll start with the market potential because if you hear a number of $200 billion as a cosmetic potential. You are really talking about the global potential of the use of cosmetic product. It is a huge market just go to department stores, etc. and then you’ll find out. However if you drill it down to the level where we are with the anti-collagenase, anti-tyrosinase that is only a fraction of the $200 billion market. So the $200 billion gives you an idea of what you could do in the cosmetic space if you were really focused on all the different targets that could be potentially targeted. For two pharmaceuticals we have currently preclinical development, actually pre-consumer testing that is probably more -- it’s a smaller market than the 200 billion. It is probably closer to a few billion dollars only and again that it will be competing with retinals and he NTE pigmentation products that currently are on the market. But it in terms of the faster path to markets, well, once you have established and there is a set of test that needs to be done in vitro you are not allowed to do animal testing with cosmetic ingredients. Actually you are not getting access to certain key markets like the European market or the Californian market when you have done animal testing with cosmetic. You brought its all ingredients. So the regulatory agencies have identified the number of vitro test that can be so that you can make decent projections that topical application of certain compounds based on those individual test are not going to add negative toxicity effects on patients or on consumers. Meaning that you can make the jump from preclinical to consumer testing which is more acceptability testing irritation testing on consumers. But also testing against the claims that could be made like for instance improves the appearance of wrinkles or improves the appearance of multi hyper pigmentation. And that allows us to move faster into human testing and once you have human testing on those compounds it is a lot easier to move them down into the business development arena where a number of large companies would be significant takers of those new products. Of course an interesting side effect of this is that when we do -- because many projects for development therefore cosmetic use improved over the periods. We automatically also get a glimpse of what other molecules, other compounds to get to safe target could do when we put them on a drug development track which would be longer, more expensive but would likely also command higher presence. Is this the answer to your question Catherine.

Unidentified Analyst

Analyst

Yes, it does. Thank you very much.

Operator

Operator

And that is all the questions we have in the queue at this time.

Tamara McGrillen

Management

Ladies and gentlemen once again thank you for participating in our call today. At this time I will turn the call back to the operator to close up the session.