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Phio Pharmaceuticals Corp. (PHIO)

Q3 2016 Earnings Call· Thu, Nov 10, 2016

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Transcript

Operator

Operator

Good afternoon ladies and gentlemen, and welcome to the RXi Pharmaceuticals’ Third 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 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.

Dr. Geert Cauwenbergh

Management

Thank you very much, Tammie. I want to thank you all for being on the call this afternoon. As you've been able to read from our press release and in our 10-Q for the third quarter of 2016, our company has been able to maintain a significant level of austerity while progressing our projects according to plan. Our Chief Development Officer, Pam Pavco will give an overview of what we've achieved in the third quarter and in the first weeks of the fourth quarter. But first, I'd like to spend the first part of our Q3 company review on the topic that I consider potentially transformational for our company and for the management of hematological malignancies as well as solid tumors. We've negotiated an exclusive option to acquire MirImmune Inc., a biotech company from the Boston area with the focus on the use of our sd-rxRNA technology to harnessing themselves through transfection for cell therapy. A little over 18 months ago, MirImmune obtained a license from RXi for the use of our proprietary sd-rxRNA technology for using cell-based immunotherapy in cancer. With this license, they received seed funding from Tim Barberich, founder and former CEO of Sepracor. Since that time, the MirImmune team has achieved many important milestones with this technology. First, they identified sd-rxRNA compounds against six different checkpoint targets, and demonstrated dose dependant markdown of these checkpoints with those lead compounds. There were no noted toxic effects from the cultured tumor immune cells and approximately 100% viability was maintained. Those results compared very favorably with the cell viability data with other transfection methods that do not use our cell delivering technology. MirImmune also demonstrated that transfection of immune cells with sd-rxRNA compounds occurred rapidly in more than 98% of the cells in cultures and that culture section of…

Caitlin Kontulis

Management

Thank you, Geert, and good afternoon everyone. The Company ended September 30, 2016, with approximately $4.4 million in cash in cash in short term investments as compared with $5.8 million and $10.6 million in cash, cash equivalents and short-term investments at June 30, 2016 and December 31, 2015 respectively. The Company's net cash used in operating expenses during the third quarter of 2016 was $1.6 million, as compared with $1.9 million during the third quarter of 201. The Company has continued to maintain an average quarterly cash balance burn of $2 million in line with our projections and expectations. Additionally, during the nine months ended September 30, 2016 the Company had received growth proceeds of $152,000 due to the sale of its common stock to Lincoln Park Capital under the Company's outstanding equity line with the fund. The Company plans to continue to conservatively modernize its cash out flows and to use the available equity line to help fund operations. Turning next to the Company's income statement, research and development expenses were $1.5 million for the quarter ended September 30, 2016, compared with $1.7 million for the quarter ended September 30, 2015. The decrease in research and development expenses was primarily due to drug manufacturing expenses for the RXI-109 drug product that was completed in the second half of 2015, offset by an increase in manufacturing and clinical trial-related expenses for Samcyprone incurred during the current quarter. Research and development expenses further decreased from the prior year quarter due to a decrease in non-cash stock-based compensation expense related to the full vesting of stock options that were granted in 2012. General and administrative expenses were $750,000 for the quarter ended September 30, 2016, were compared with $770,000 for the quarter ended September 30, 2015. The decrease in general and administrative…

Dr. Pamela Pavco

Management

Thank you, Caitlin, and hello everyone. As Geert said, I will be providing a brief update on our ongoing clinical trials and on our ongoing research activity. Our first clinical sd-rxRNA, RXI-109 is currently being evaluated in two different clinical studies. Our Phase 2 trial Study 1402 for the management of hypertrophic scars after scar revision is fully enrolled. Based on a preliminary evaluation of the three month data, we have added an additional two cohorts to evaluate an extended dosing regimen to better cover the length of time that scar can continue to form on a person that has permanent hypertrophic scar. For these two new cohorts, additional doses are given at four, five and six months followed by a three month observation period up to nine months. The subjects in one and two and cohorts one and two received only three months of treatment and were followed up to nine months as well. The subjects in the first two cohorts have completed the nine month study and we plan to provide a summary overview of these two cohorts by the end of the year. We also expect to provide an interim review of the safety data and preliminary clinical activity for the subjects in cohorts three and four will reach seven month before the end of this year. As before, our evaluation will be a blinded comparison of the photograph of the treated versus untreated in incisions and scars. The last enrolled subject in Study 1402 is projected to complete the nine month study in mid-2017, so our final complete readout and formal reporting of this study will happen in Q3 2017. The second ongoing study with RXI-109 Study 1501 is evaluating the safety and tolerability of intraocular injections of RXI-109 in patients with advanced wet AMD and…

Tamara McGrillen

Management

Thank you, Pam. This now concludes the formal presentation for today and at this time operator we would like to poll for calls please.

Operator

Operator

Thank you. The floor is now open for questions. [Operator Instructions] And our first question comes from Keith Markey [ph]. Please state your question.

Unidentified Analyst

Analyst

Couple of questions about the RXI-231 program, I was wondering with the manufacturing ongoing and such just when we might anticipate starting the study of that therapy and also I guess it's cosmetic I should say and how long -- how many individuals you might enroll in that type of study; not just the safety but also the effectiveness study?

Dr. Geert Cauwenbergh

Management

Pam, I think that's exactly something for you.

Pam Pavco

Analyst

We are expecting to have the compound manufactured and released by early in the beginning of the quarter first quarter and we can formulate and go into the safety studies right away after that. The studies, the first studies are a couple of well like we repeated irritation studies where you do, apply the patch to the same spot over a period of time, and we believe we're going to treat about 25 people into each of those studies but those can go rather quickly because they volunteer and you can have them pretty much come in all in a few days and start the series of patch testing and work through that in several weeks. I forgot if there was more to that question?

Unidentified Analyst

Analyst

Well, actually a broader another question and that is -- is there two different formulations and that's the reasons you're having two studies? And then the part that I was asking before about was simply, how larger the trial or study would you do for the actual efficacy portion of assessing the therapy?

Pam Pavco

Analyst

So, for the safety studies, there's two studies because one is determined if there's irritation and one is a longer study where you do a repeated application of the compounded CFU sort of increased sensitivity and get more irritation or not. For the actual study with the UV, we're going to be looking at whether we can alter the hyperpigmentation that occurs after UV exposure; we haven't determined our final protocol for that; so I can't say how many subjects we'll have in that. But again you can do multiple spots on the same person so we may be able to keep it at to a very limited and short-term study to be able to get an answer.

Operator

Operator

Thank you. And our next question comes from Justin Foster [ph]. Please state your question.

Unidentified Analyst

Analyst

Congratulations on the MirImmune deal that sounds fantastic. Can you give a little more color to the share offering that's you've announced. Is there a possibility of a private placement or can you give us an idea of the status of that at this moment?

Dr. Geert Cauwenbergh

Management

Caitlin, I hand it over to you.

Caitlin Kontulis

Management

Sure. Right now because we are in the period from our original filings as to be going effective will eliminate to what we can discuss in relation to the filing so at this time will just tell our investors and our shareholders to the EDGAR, website which has our original filing and for any future updates in filings will be posted on that website at that time and just due to the filing period that we are in where as SEC rules and regulations that limit us and to speaking towards this.

Unidentified Analyst

Analyst

Can you mention anything regards to timing at all or you also not talk in that respect?

Caitlin Kontulis

Management

Yes, we are limited here while we are in the filing period, so will refer everybody to the SEC website when there is update that's where that will get posted.

Unidentified Analyst

Analyst

Understood. Finally, are you still working with Griffin in terms of finding partnerships and transactional questions like that?

Dr. Geert Cauwenbergh

Management

We are still interacting with the Griffin on certain project, yes.

Unidentified Analyst

Analyst

And were they instrumental in this arrangement with MirImmune or is that not a question you can answer?

Dr. Geert Cauwenbergh

Management

Please not to answer that.

Unidentified Analyst

Analyst

Okay, thanks very much.

Operator

Operator

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

Tamara McGrillen

Management

Well, operator. Then I'd like to thanks everybody for participating on our call today. And we may end the call.