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

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. Please be aware we may make forward-looking statements during this call.

Although statements represent our best estimates and expectations, actual results could differ materially from our 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..

Thank you, Tammy and good afternoon to everybody. Thank you all for joining the call today. Before turning it over to our management team, I will highlight some of the events that have taken place in the past months and then will explain seven key initiatives that we expect will create value for our company in the next 12 months and beyond.

In the second quarter, we achieved a major milestone in our shareholder structure, with the elimination of the preferred shares and their associated dilutive quarterly dividend.

The participation of several premium brand investment firms had new shareholders in our recently completed financing, provided RXi with a much broader and more solid shareholder base, eliminating the overhanging price volatility caused by those preferred shares, the conversion and sale of which caused our share price to decline.

This financing provides us with at minimum an additional year of cash, allowing us to focus on rebuilding our share price through data generation and business development activities.

In the past weeks, the Board and the Management of the Company have made a detailed assessment of the opportunities that we have internally to generate data and increase shareholder value in the next 12 months. I will now highlights seven key initiatives that we expect to become building blocks for renewed shareholder value creation.

First of all, RXI-109 as a hypertrophic scar treatment. Our goal is to accumulate in the coming 12 months sufficient learning to design a key Phase 2b dose finding study.

Our study RXI-109-1402, which is a dose finding exploration study has fully enrolled the first two cohorts of ten patients, each who have undergone scar revision surgery and are receiving six dose with our drug over a three-month period compared to a portion of the revised scar area in those same patients that has not received treatment.

At this point, a little more than half of the patients have reached the three-month time point of the study and we hope to have preliminary three-month readout for a subset of subject in October. We plan to follow this initial part of the study with two additional cohorts in which the dosing period will be extended with additional doses.

We expect that the data points from this dose finding exploration as well as from our earlier study 1301 will provide us with sufficient evidence to design a formal Phase 2b study.

Currently with almost 100 patients and volunteers treated with RXI-109, the safety profile of the drug continues to be good and several patients participating in the study have already expressed the desire to also have the controlled side of their scar revised a second time to retreat it with RXI-109. So for the first building block.

The second one, ophthalmology is our second therapeutic area for clinical development of RXI-109. We filed our ophthalmology R&D with RXI-109 for retinal scaring a few weeks ago. Pam will talk more about that. And hope to be able to start recruitment of patients for this Phase 1 / 2 study early in the fourth quarter of this year. Dr.

Peter Campochiaro, a rental surgeon and global key opinion leader in this space, who works at the Wilmer Eye Institute at Johns Hopkins is spearheading this clinical effort.

In addition to this work using RXI-109 for intraocular injections, we are also progressing preclinical work for topical delivery of the drug to the cornea of the eye and are aiming to make solid progress in that space. Brining me to the third building block, Samcyprone to enter a Phase 2 clinical trial for treatment of cutaneous warts by year end.

While we are further expanding our intellectual property position for this topical form of immunotherapy, the key priority with this product for us is to enter as quickly as possible in a Phase 2 study for treatment of warts, a dermatological indication with $500 million market potential in U.S.

and the Company has an open eye -- and it’s currently undertaking the necessary steps to finalize the Phase 2 protocol, update the investigators brochure at cGMP manufacturing and IRB approval online and to enable the start of the study by -- in order -- we would be able to start the study by year end.

That brings us to action item four or building block four. Timeline driven preclinical development of our RNAi compounds against collagenase and tyrosinase. In the past several months, we have demonstrated nice dose dependent [indiscernible] in messenger RNA and protein levels for our compounds targeting these two important enzymes.

In addition, we recently added in vitro studies in cell cultures and in skin equivalents that also demonstrated that these compounds have a phenotypic biological effect on their molecular target.

We have received strong interests from some combined exploration of these compounds from third parties both in the therapeutic and in the consumer skin care space.

We expect to make continued progress with exciting data generation in the months ahead, which should allow us possibly in collaboration with others to put one or more of these compounds on a clearly-defined development track either for use in the consumer cosmetic skin care space, which would grow faster or for therapeutic purposes.

Moving on from that angle to more of the business development side, where there is three building blocks we’re working with number five of the seven points, early partnership that can provide non-diluted funding for identified R&D activities.

In the last months, we have approached several pharmaceutical and biotech companies with the proposal to provide them with an option to in-license our sd-rxRNA platform for a specific therapeutic area and/or against a well-defined protein target of their choice.

As demonstrated with our collagenase and tyrosinase development, RXi Pharmaceuticals is capable of arriving at therapeutic candidates against such targets in a relatively short form and period.

We would aim that partner would provide funding to RXi to identify active sd-rxRNA compounds against the target of their choice and in parallel, a term sheet would be developed to support a development arrangement once those compounds have been synthesized and tested in cell cultures.

The third business -- the second business development building block is the potential of the selective spin-out and/or licensing approach. Over the course of the past several years, we have generated a good data base both chemistry and pharmacologically with our cell delivery on RNAi [ph] platform for the potential treatment of a variety of diseases.

As a result, our platform can form the basis of the spin-out in the form of new separate companies or for mergers with already existing companies.

The spin-out approach has been a substantial -- has seen a substantial uptick in activity in the last few years in general in our industry as was recorded in a recent article published in the July edition of the M&A leadership council.

As we have demonstrated with our license of the sd-rxRNA technology for ex-vivo use in cell therapy for cancers to MirImmune, such licensing deals or spin-out transaction can provide future upside value for our shareholders because of the equity position RXi may obtain under those deal terms.

In a sense, RXi with this approach is using its intellectual property capital, the same way venture capital uses its financial capital to gain a partial ownership and create value for its investors. We expect more of the MirImmune type deals to materialize in the coming 12 months.

Finally, in the seven building blocks, the third in the business development section, larger deals with equity investments by strategic partners. There are many strong regional players who are eyeing expansion outside their own geographic business territory.

Because of the broad nature of our IP portfolio, our Company is well placed to start negotiating such broader deals.

This has been a fairly constant approach for us in the back half year and although the signing of such deal is not easy to predict, we feel based on our past discussions with some of these players, that this approach could also materialize in the next 12 months.

In summary, I’ve tried to provide you with a picture of where we are taking our Company in the next 12 months. Working on these seven building blocks may sound ambitious at first sight and yes, indeed it is not the small task.

However, in view of the data that we are produced over the past three years, the valuable IP portfolio that has been generated and hard work and investment that has already gone into several of those seven building blocks that I mentioned, we feel that there is a realistic possibility to achieve sufficient progress in each of them to justify the significant appreciation of our Company value in the 12 months ahead of us.

I look forward to working with each and all of you our shareholders to arrive through constructive feedback and interaction that are our ultimate goals. That is to give RXi the leadership position it deserves based on its unparalleled technology platform in the RNAi space. And I am now happy to hand it over to Ms. Kontulis for the financial discussion.

Caitlin?.

Thank you, Geert. As we reported today, the company's net loss attributable to common stockholders for the three months ended June 30, 2015 was $2.2 million or $0.05 per share compared with $3.2 million for the three months ended June 30, 2014 or $0.23 per share.

The decline was driven by a decrease in the fair value of dividend paid on both periods of the company's preferred stock.

This was due in part by a decrease in the company's share price on the dividend payment date which is used to calculate the fair value of the dividend as well as by a decrease in the shares accruing dividend this quarter as compared with the same period in the prior quarter.

Total operating expenses for the quarter ended June 30, 2015 were $2.2 million compared with $2 million for the quarter ended June 30, 2014.

The increase in expense was primarily driven by subject and trial-related fees for the company's current clinical trials primarily for program costs for a second hypertrophic scar Phase 2a trial Study 1402 as the first Phase 2a trials in hypertrophic scars and keloids are coming to a close.

Net cash used in operating activities was $1.8 million for the second of 2015 as compared with $2 million for the second quarter of 2014. While the company has seen an overall increase in expenses as compared to the prior year, we have been able to keep our cash burn at a consistent rate of approximately $2 million per quarter.

Our net cash used in operating activities was primarily driven by research and development costs in our dermatology franchise for our three ongoing clinical trials in hypertrophic scars and keloids, namely Study 1402.

Now turning to the balance sheet, the company had cash, cash equivalents and short-term investments of $14 million at June 30, 2015 compared with cash and cash equivalents of $8.5 million at December 31, 2014. The company strength its cash position with a close of a public offering of common stock and warrants in June of this year.

As part of the offering, the company sold 26 million shares of common stock for gross proceeds of $10.4 million. The shares were sold as part of the unit and as such investors also received a 30-month warrant and an exercise price of about $0.46 and a five-year warrant with an exercise price of $0.52.

If all warrants were to be exercised, the company would receive an additional $12.7 million in proceeds. With this financing the company was also able to expand its shareholder base with the participation of well-known institutional investors and a number of retailer investors.

Additionally some members of our management team and board of directors also participated. We believe that our existing cash should be sufficient to fund our operations for at least one year.

So if we can continue to keep our burn rate aligned with the $2 million per quarter we’ve done so far this year, we expect to have cash to fund operations through Q1 2017 and to end the current year with approximately $10 million.

Our common shares outstanding at June 30, 2015 was 65 million which increased from 31 million outstanding on March 31, 2015. This increase was driven primarily by the shares issued at our offering in June as discussed previously and as a result of conversions from the Series A and Series A-1 preferred stocks.

These preferred shares were fully converted during the quarter resulting in a simplification of our capital structure with only common shares remaining outstanding at the end of the quarter. The quarterly dividend on June 30 was accelerated to the end of May at which time the dividend payable were immediately converted into common stock.

Note preferred shares remain outstanding, nor will there be any future preferred dividend payments. As a result, we expect to see a stabilization of our share price without the pressure from these preferred share conversions in subsequent sales.

As disclosed in our public filings, the company has received a notice from NASDAQ that we are not currently in compliance with the listing requirements as our share price is trading below the $1 minimum debt price. Currently, this fare [ph] has no effect on our trading nor have we been on move from the NASDAQ Exchange.

In order to regain compliance, the company’s share price needs to trade over $1 for ten consecutive days with a deadline of November 3 in order to do so. There is a risk of delisting and that we do not regain compliance by this time, however, we may also be eligible for an additional extension to reach compliance.

The first thought that may come to many of our shareholders’ minds is that the company will complete a reverse split in order to regain this compliance. While we cannot completely rule out this option, we plan to appreciate our share price organically.

How does the company expects to do this? We have a number of expected milestones coming in the remainder of this year and in to next year that we are hopeful will send a positive signal to the market and to our shareholders.

These milestones include the filing of an IND with RXI-109 for the scarring component of retinal diseases which we just recently completely, beginning a Phase 1/2 clinical trial in this indication and reporting three and six month results from the ongoing study 1402 and initiation of the second half of this study with an optimized dosing regimen.

In addition, the company also plans to initiate a Phase 2 study with Samcyprone for cutaneous warts before the end of the year. These key milestones have the potential to provide significant value to the company and to our shareholders. More detailed information can be found on the Form 10-Q filed with the SEC today.

With that, I will turn the call over to Dr. Pavco who will discuss the company’s research and development activities..

Thank you, Caitlin. Hello, everyone. For the next few minutes, I will give you an overview of our research and development programs at RXi. I will start with an update on RXI-109 for both our dermal and ophthalmology programs, and then we’ll view our ongoing work with Samcyprone.

First and foremost, at the end of July, we filed an IND for the use of RXI-109 for the treatment of the retinal scarring component of wet age-related macular degeneration or wet AMD. We are currently in the 30-day wait period with the FDA before we can initiate this trial.

During this wait period, we are in the process of obtaining approval from the Institutional Review Board at Johns Hopkins’ Wilmer Eye Institute and working closely with Dr. Campochiaro and his team to be able to initiate the trial as soon as possible thereafter.

Because we shared the proposal for the clinical protocol previously with the FDA and had a positive interaction at that time as part of the pre-IND documentation, we believe that the FDA will not have any further comment or questions at this time.

Based on this, we are on track to initiate the clinical trial as it has been submitted to the FDA by early in the fourth quarter. The trial itself will be known as RXI-109 1501.

Subjects in this trial will have advanced AMD, meaning that they have already had AMD for a while and likely have already been treated with the standard of care anti-VEGF medications. These drugs like Lucentis work to block vascular endothelial growth factor, VEGF, which is a cytokine that stimulates the neovascular component of AMD.

Elevated VEGF levels cause aggressive blood vessel growth, leakage and disruption of the retina at the back of the eye, leading to vision loss and blindness. The anti-VEGF treatments are quite effective at reducing this blood vessel growth and leakage and allowing the retina to maintain normal activity.

Eventually though, many of these patients continue to lose vision. What you may not know is that after two years of anti-VEGF treatment, over half of the patients have scarring on their retina. This scarring is permanent. It cannot be reversed and it is a major component of continued vision loss. This is where RXI-109 comes in.

As you know, our drug targets and reduces connective tissue growth factor or CTGF, but plays a role in scar formation. Just like for scarring at the skin, CTGF is involved in ocular scarring as well.

Our ultimate goal is to block the scarring that is secondary to the neovascular disease of wet AMD and in doing so, preserve vision for a longer period of time. As I mentioned, the subjects in the clinical trial will have advanced AMD and they already have some sub retinal fibrosis or scarring and vision loss.

This trial is intended to be a dose escalation trial and that it will evaluate the safety of RXI-109 at several dose levels. Under Dr. Campochiaro’s guidance, the proposed trial is a multi-dose trial that bypasses conducting a separate Phase 1 study with a single dose as is often done to establish safety.

As you can imagine, this strategy saves a significant amount of time and money by allowing us to get a glimpse of efficacy at the earliest possible time. Because we will be evaluating early evidence of clinical activity along with safety study 1501 is considered Phase 1-2 trial.

A compound that could block ocular scarring would not only be advantageous for patients with advanced AMD. Retinal scarring leads to a loss of vision regardless of the underlying indication and an agent that could block retinal damage could also be useful in patients with diabetic retinopathy.

Another indication is proliferative diabetic [ph] retinopathy or PDR, which is a complication following a retinal detachment. 5% to 12% of people who have a retinal detachment may end up with PDR. After the initial retinal detachment, scar like membranes can grow and result in traction of pulling on the retina and it can become detached again.

If a person is prone to PDR, this may continue to happen many times. You can see that a drug that could prevent or slow these scar membranes from forming could be a great clinical benefit.

Once safety is established in study 1501 in advanced AMD patients, and we have some preliminary evidence with activity, we might be able to expand into these other areas. Moving RXI-109 into a second disease area was cost effective for us. CTGF is, as you know is a key component of scarring in the skin and the eye and thus it’s a good target for both.

We had generated a solid safety base for RXI-109 in the skin and already have an indication in this clinical activity there, because the same drug product issues for both types of trial there is no duplication of drug manufacturing or preparation of vials for clinical supply.

Also we have IND supporting toxicology already completed for the dermal studies, so we only had to supplement these scar free [ph] studies with specific ocular toxicity studies. Taken together, these are huge cost and time savings.

Currently, there are three ongoing Phase 2a trial in which the effective RXI-109 on scar formation in the skin at surgical revision sites are being evaluated to either scars or keloids. Subject participation in two of the three studies is complete, meaning that the last subject in these two trials has had his or her last visit.

We are in the process of completing collection of all the safety and observational data for studies 1301 and 1401 and working towards completion of a clean and large database for each of them.

As these two initial studies were being conducted, we took advantage of early looks at preliminary data to refine the dose and dosing regimen for a third trial known as RXI-109-1402. Study 1402 is designed to further evaluate the clinical effect and tolerability of RXI-109 and reducing the recurrence of hypertrophic scar formation.

Study 1402 is created with an adaptive protocol, meaning that as we learn more about how the drug is working, we can adapt the protocol to reflect these learnings, and I’d like to explain how we did that.

In the first two cohorts of study 1402, subject receives scar revision surgery on one or two scars and receive either 5 or 10 milligrams of RXI-109 per centimeter of insulation length.

In this trial, we had initiated dosing at two weeks rather than immediately after surgery, a finding that we established from study 1301 where we learned it may be better to wait until after that initial information base when the wound is first closing and netting together.

Early in study 1402, we further adapt the protocol based on additional information from study 1301l, finding that it may be better to lengthen the dosing period to better extend through the proliferation phase of wound healing to continue to keep the scar at bay.

Because of this, subjects in the first two cohort are receiving six doses of RXI-109 rather than the four that we originally planned. These two cohorts are completely enrolled with approximately 10 subjects each. In study 1402, the three-month visit of the last subject does not occur until December of this year.

Instead of waiting that long, we will conduct a photo review of the subjects or a subset of the subjects that have reached the three-month time point at the end of September. This partial data set will be available. This partial data set will be available in mid-October.

These subjects were only have received five of their six doses since they’ve received their sixth dose on their three-month visit. For reference, the six and nine month phases will occur late in the first and second quarter of next year.

These latter two time points will be indicative of a lasting effectiveness because the scar will have had more time to mature. In the meantime, we are also planning to add two additional cohorts to this study to gather enough information to develop a strong Phase 2b protocol.

While the study is not -- study design is not complete, we intend to evaluate two extended dosing schedules that will include additional doses out through their six months visit.

The preliminary three months photo review that I just described will help -- the data from that will be used to helping from the study design for these two additional cohorts. The current plan is to submit a protocol amendment to add these two cohorts and to initiate them before the second half of this year -- in the second half of this year.

Since we are expanding our hypertrophic study that I just described and because we still need to manage our financial resources, we are reprioritizing the keloid study and will revisit it in 2016.

This will allow additional safety data to be collected on subjects in the scar study who have received six or even more doses and they provide useful information on a more optimal dosing regimen itself. Before moving on, let me briefly recap our plans for the programs with RXI-109.

First, in October, we will provide preliminary results from a subset of the subjects in study 1402 who have reached three months after their surgery and who have received five of their six doses.

Also, in the fourth quarter, we intent to initiate a third and fourth cohort in study 1402 to evaluate a more extended dosing regimen for hypertrophic scarring that includes dosing out to six months. In the ophthalmology program, our IND is filed and we plan to initiate our first ocular study in the fourth quarter of this year.

During the same time frame, we are also working towards initiating a trial with our immunotherapy Samcyprone for the treatment of cutaneous warts, which I will tell you about next. Now, as Geert mentioned, we’re on track to enter into Phase 2 clinical trial with Samcyprone for the treatment of warts by the end of this year.

Samcyprone is a topical formulation of diphenylcyclopropenone or DPCP that RXi acquired in February 2015. DPCP is a total topical context synthesizer that works by eliciting a subject’s own T-cell response. DPCP is already known to be an effective treatment but it is not an FDA-approved drug and there is no standardized use.

As I’ll explain in a minute, we think that Samcyprone formulation will allow this potent drug to be used more safely and more effectively. The study design for this trial is in progress. The primary study endpoint will be clearance of Samcyprone-treated warts versus untreated warts.

After sensitizing the subjects with the full strength Samcyprone formulation. One set of warts will be treated with the lower concentration of Samcyprone on a weekly basis and with the comparison overtime to untreated warts.

While clearance of the treated warts will be a primary endpoint of the planned study, important information will also be obtained about the formulation itself.

In current use, DPCP is not an approved drug as I said and because there is no standard way to use DPCP, it must be formulated generally in acetone by a pharmacist based on directions from individual dermatologist. This liquid solution must then be applied to the skin or wart area.

We believe that our Samcyprone formulation, which is more like a gel, will be easier to use and because it may facilitate the uptake of DPCP, it will allow a reduced level of DPCP to elicit the same immune response thus reducing the unpleasant side effects while maintaining efficacy.

RXi holds the IND and the patent for the Samcyprone formulation and if the trial is successful, we believe that it will be relatively easy to convince dermatologists that it’s better to use the formulation that is regulated by the FDA rather than chemical that the local pharmacists must compound.

Samcyprone may also be effective in other disease areas as well as evidenced by literature that DPCP in a liquid acetone formulation is found to be effective.

Conducting the wart -- conducting a trial in warts where the patient population should be very easy to recruit will allow us to very quickly build the safety database that will support investigator-sponsored trials in other areas.

Having said this, an effective treatment for warts, especially for recalcitrant warts continue to come back for those that are hard to treat such as those that affect nail bed would be welcome dermatologists. Overall the market for wart treatment in the US alone is $500 million.

Warts, as you know, are an extremely common childhood problem as up to 10% of you listening to me know, but it is also a long term problem in many adults especially the cluster or plantar warts which are currently not very well treated. With that, I will now turn the call back over to Dr. Cauwenbergh..

Thank you, Pam. As you have heard from our team today, the company has been working diligently towards not only achieving the 2015 corporate goals outlined at the beginning of this year, but also looking at to future and value creation catalysts to increase shareholder value.

These seven key initiatives were explained in the beginning of the call today, and we believe our rebuilding blocks that will rebuild our share price.

As I mentioned this morning in our press release, the cash run rate that we now have due to the recent financing provides us with the ability to work on these initiatives as we aim to, number one, advance our preclinical and clinical pipeline.

Number two, generate partnership deals and number three, deploy our self delivering sd-rxRNA technology platform in a portfolio approach akin to the way venture capital firms deploy their capital through establishing equity positions in young biotechnology companies to create value for our investors.

Once again, thank you for taking the time to participate on the call today and I will now return the call back Mrs. McGrillen..

Thank you, Geert. That concludes the formal portion of our presentation today. Operator, at this time, we would like to poll for questions, if any..

[Operator Instructions] We do have a question in the queue. This one comes from Mark. Go ahead, Mark. You are live..

Hi, guys. Thanks for taking the questions. Congratulations on all the progress. I just want to ask, in previous calls, I think we’ve discussed some ongoing efforts to perform quantitative volume metric analysis of scars to provide firm measurement of treatment efficacy in conjunction with using a blinded panelist estimate.

Are these efforts still ongoing?.

Hi, this is Pam. Because we are taking 3D photographs of the scars along the way, we do intend to try to use a volumetric measurement.

It turns out it’s a lot harder on scars than you may think, because the differences from previous scars that were revised to the scars that we see the SEMs may be easy to differentiate, but it’s a little bit harder to differentiate amongst scars that have been revised and don’t have very much volume, revised and treated and don’t have very much volume.

So we are continuing to try to include that in our assessments. It may be more important than we are doing QAs [ph] which have a much – may have a much bigger volume. So, yes, we are trying to keep those in our assessments..

Okay, got it. And another question on the scarring program.

Given all the flexibility that’s sort of built into the 1402 trial, your ability to add additional cohorts, can you clarify for me what would be different in a formal Phase 2b study? Why couldn’t we essentially get that information by adding additional cohorts to the 1402 trial?.

The major difference is the way we do it now is sequential. And so we learn and we adjust based on what we see that’s a protocol design.

When you want a formal dose finding study, it needs to be randomized, meaning that you cannot do it sequentially, you don’t -- once you lock yourself into a formal dose finding study it’s not an adaptive design anymore and that is the prelude to the annual Phase 3 program, so that’s the difference..

And also in the Phase 2as, we are doing relatively small cohorts because we want to get an idea of what’s going on and apply that to the next you know like to the next set of studies. So in Phase 2a there is fairly small and Phase 2b, we’d likely chose one or two dose regimens and then apply that to a broader patient base..

Okay got it, that makes perfect sense.

Finally, one last question based on your collaboration with MirImmune, are we expecting to see any preclinical data coming out of that later this year or even early next year?.

Since it’s MirImmune that has -- that’s taken the license, we are basically a 10% shareholder. We are not in control; we are not in control of how they work. We know that they have some work ongoing in collaboration with an academics vendor in Europe.

And I certainly would hope that some data become available but we have little control over that, they’re in charge..

Okay, thanks. All right, thanks for taking the questions..

Thank you for those questions Mark. The next question comes from Keith. Go ahead Keith, you’re live..

Hi, thank you for taking my questions. I was wondering if you might be able to elaborate a little about the 1501 trial, for instance, what would be the timeline, secondary endpoints, number of dosages that you’re going to be testing, that sort of thing..

I can say a little bit but since we’ve just submitted that to the FDA and we haven’t actually been confirmed that we can go forward, I hate to say too much.

We will be doing multiple doses; they’ll be on a similar you know if we’re approved for what we have in -- have submitted to the FDA, we’ll do multiple doses on a schedule much like Lucentis or the current anti-VEF drugs are given for monthly.

And the intent there is to do the first dose and follow that by a very comprehensive safety assessment before we would move on in those same patients to dose -- to continue dosing.

So the initial dose will be followed by all the normal exams you get when you go the eye doctor but we’ll also include a number of more detailed assessments like fluorescein angiography, OCT which is a way to look at the back of the eye and non-invasive way to look at the back of the eye and look at the health of the retina and things like that.

So that’s sort of a general overall plan but the study will be under -- each patient’s involvement will be under a year..

Okay, great thank you.

Will the patients till be treated with Avastin during the study or are these patients who have [indiscernible] taking the Avastin?.

If these patients -- if their doctor is prescribing Lucentis or Avastin or whatever anti-VEGF treatments that they’re on, they will be allowed to continue.

Some of these patients, well we don’t know yet, it depends on who becomes enrolled but some of these patients, the VEGF treatment has not -- has stopped working essentially, so they may not be getting a VEGF treatment at this time but either way, they would be allowed to enter into the trial.

The most important part is that they have advanced disease and that gives us a chance to look at -- to potentially see some scars and see that maybe the chances that we could slowdown the grow of the scars that are already there..

Would you expect or do you think it’s possible that some scars would be in -- to certain extent reduced in size?.

Our drug does not reduce scars, it really only reduces the formation of scaring. So just -- I believe that the scars that are already there would just not be -- our goal would be to prevent their progression..

Okay. Thank you..

Part of why this is an important drug is that if it were to be able to prevent progression and you’re able to give this to patients earlier in their course of disease, you would be able to prevent the formation of the scars that naturally comes, even though the stations are on anti-VEGF treatment.

And so that could preserve their vision for a longer time..

Right. And then I was wondering, one of the things you did at least it seems like in evaluating your MMT1 siRNA, was to look from biological activity by monitoring mobility of the cells and I was wondering those were cancer cells.

Is there any interest or has there been any interest expressed from outside parties to take this particular siRNA in to the clinic for development or cancer treatment..

Not specifically for cancer treatment at this moment, but as I alluded to, we have been talking to some players through some companies in this space to work with us – collaborate with us on tyrosinase or the Collagenase program, but I agree with you Keith that the observation on all the cancer cells could be of interest.

I would probably like to see more work done internally, so that we have stronger database to make a bigger splash..

Do you think that you will retain at least some of the rights to these compounds and maybe give your partner a few – working in Tyrosinase or Collagenase initially so that you can, do you think you can give them an option to acquire the drugs, upon further investigation that you would be doing or do you think you’re just moving off to the other parties to development?.

Right now, specifically Collagenase, Tyrosinase, there are several possibilities. As I pointed out, we have a very good candidates about to get Tyrosinase and then other candidates getting Collagenase.

We are selecting, one, to put more on an consumer cosmetic skin care track and the other to put on a therapeutic skin care track and it is certainly possible that we up the marketing rights for this separately.

The intent in general from business development point of view is that for our own market, the US, we would like to keep rights even if it is semi exclusive together with a larger partner, but the rest of the world pretty much is something we are quite willing to basically license out.

That’s also the reason why I mentioned in one of our building blocks for business development that our target is certainly the regional partners or the regional players that are trying to break out of their own geographic territory and become builder..

Thank you very much..

Thank you, Keith. The next question comes from Hobart. Go ahead. You’re live..

Thank you for taking my question. First of all, you filed the IND for macular degeneration.

Can you tell us the exact date that it was filed?.

As we have announced, we filed it a few weeks ago and as I’m sure you know, there is a 30 day waiting period. It is unlikely that we will immediately start with a clinical study on day 31, because that 30 day period is basically by law. The -- still the IRB, well we are interacting with the IRB.

So we are not providing, so what’s the key date is not when you file the IND, the key date is really when you are able to get started with the study..

I understand. And so I am happy to hear that you are concerned about the stock price, because market cap is king. Without it, you are in a very difficult situation. And I worry about 12 months, six months, that in this time period you will be attacked by short sellers who will view you as a target.

And when you say generate partnerships where are you in that process? You need team members, who are you – how are you going to bring people, other companies, larger companies into the fold to protect your side of the field?.

So there is various ways we can do it. First of all, certainly trust me, I understand that market cap is a very important piece. I also and I don’t want to dwell on the past. Look, the company got originally financed by Galena and the hedge fund people, the way it was, we had to work through that.

We are highly committed as I hope to be very clear to rebuilding the share price. And I feel confident that we can do that.

One of the items or the aspects and I cannot go into the details of with whom we are talking, but one of the aspects that comes up when we are doing, talking something like that is that there is commitments from a partner, for instance, from a strategic partner with a sign up to work with us on a regional license or what have you.

But they would be buying stock in the open market. And that is basically one of the things that I can definitely put on our wish list, a list of things to -- and we are actually looking this for reference, although reference of course we are asking for it, but the shareholder value to us is very primary in terms of a concern.

So we see that such partners would agree to buy shares in the open market, that is in my opinion a reasonable way to try to increase the shareholder value..

I am glad to hear that. And it’s good to hear that management is paying attention to the market dynamics.

And I would say, I am also happy to see the cosmeceuticals, is this a new focus, because obviously the FDA is difficult to – it has many hurdles to jump through, but is this cosmetic focus now gaining more priority?.

So, first of all, if you would look at my background, I come from Johnson & Johnson where I was in-charge of development of the skin care franchise both beauty and cosmetic consumer. So Retinol, for instance, which is a cosmeceutical. That way I want to make it clear immediately cosmeceuticals are not official legal category in this country.

In this country you have only cosmetics, or skin care, consumer skin care products and drugs, OTC or Rx. In other countries like in Japan and also in China, you have something called quasi drugs, which is the same thing. It’s cosmeceutical, but it’s called quasi drug.

So it’s a new focus for RXi, but it is certainly not that the people that are working within RXi are experienced in this space. This is very important from the doctor, from the moment and that’s why we separate the compounds. We have two candidates for collagenase, anti- collagenase where we have two compounds, anti-Tyrosinase.

One is going to go on a consumer cosmetic development which is totally different. For instance, you are not allowed to do animal studies if you want to get in the European market with cosmetic products. So, it’s a totally different thing and you have to separate it completely but we are very conscious about it, we know how it has to be done.

As I said, I’ve done it before. It is not an unbeaten path, it’s a beaten path..

Great. Thank you for taking the questions..

Thank you..

Thank you..

Up next, we have Jeffrey. Go ahead Jeffrey, you’re live..

Yes. I’m a regular guy, investor in this Company, and I make 500 bucks a week. I’m your regular dude investing in the Company for the long-term and I have a lot of faith in you guys. I’ve heard a lot about you and I own some shares in this thing and what I was going to ask is a forward-looking statement answer.

Do you potentially think that your Company could have a cure for something like baldness?.

That’s an interesting question. Baldness is caused by a number of things. For instance, if I go to [indiscernible], okay, that’s a small molecule but you are attracted by, of course, because it was a Phase 2 asset and also because alopecia areata is a formal baldness.

So, if you consider that type of baldness, we actually already have a cure for that type of baldness. There are other types of baldness that have to do with microcirculation, that have to do with protein BTL2, which is [indiscernible] that is down-regulated in baldness so that apoptosis occurs more quickly and so, your hair cycle gets shortened.

So, cure against baldness, in general, the answer is no. Against substantial baldness, yes, if we get the right target we can do that..

That’s excellent, and I just want to say that my stepmother was born Marlboro, Massachusetts and I’m from Massachusetts as well. Now, I live in Phoenix, Arizona and I appreciate all your information and I appreciate what you guys are doing and I’m going to keep investing. Thank you..

Thank you for being an investor..

Thank you..

Thank you. Operator, I believe unless there are any other questions, we might have time for one more, otherwise --.

There are no further questions..

All right. At this time, we like to thank everybody for participating in the call and have a great day..

A good evening..

Thank you. This does conclude today’s teleconference. We thank you for your participation. You may disconnect your lines at this time and have a great day..