Tamara McGrillen - Investor Relations Geert Cauwenbergh - President and Chief Executive Officer Pamela Pavco - Chief Development Officer Caitlin Kontulis - Principal Accounting Officer.
Keith Markey - Griffin Securities, Inc. Reni Benjamin - H.C. Wainwright & Co..
Hello and welcome to the RXi Pharmaceuticals 2014 Fourth Quarter and Year End earning conference call. Today's call is being recorded. At this time, I'd like to turn the call to Tamara McGrillen of investor relations. Please go ahead..
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 material 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 also thank you to everybody who is on the call today. Having seen some intense activity in trading of our shares in the past several weeks, I thought that before reviewing the highlights for the past year, it might be helpful to everybody to provide a brief overview of how this company was formed.
In Q3 of 2011, the former parent company of RXi, Galena Biopharma completed a formal agreement with two hedge funds to spin out its proprietary RNAi platform into a newly created public company to be called RXi Pharmaceuticals Corporation.
These two investments funds contributed about $10 million in cash and in return received about 83% of the company in the form of preferred shares which were to receive an annual rate of 7% to be paid dividend rate of 7% to be paid quarterly in preferred shares.
The transaction between Galena and the two hedge funds was completed in April 2012 and RXi Pharmaceuticals became a newly formed independent company with a new management team and a new Board of Directors.
Shortly thereafter, in mid 2012 the company filed an IND for its first clinical development candidate, RXI-109 for prevention of return of hypertrophic scars and keloids after scar revision surgery. In March of 2013, the company completed a capital raise which achieved three things. Number one, we raised $16 million in new funding.
Number two, we acquired substantially all of OPKO's RNAi assets and number three, we broadened our shareholder base with OPKO and Dr. Phillip Frost as well as several other high quality biotech investment funds. This allowed the company to move into Phase 2 testing with RXI-109 based on our Phase 1 studies.
We had chosen significant volunteer studies at RXI-109 reduced messenger RNA for connective tissue growth factor and closed the dose dependent reduction of connective tissue growth factor protein in the scar area even up to three months after a single intradermal injection.
In addition to being able to start Phase 2 testing the new cash also allowed RXi to start looking into a potential build-out of an ophthalmology development pipeline in 2013. And this brings us to 2014. In the year 2014 it was a good year for RXi Pharmaceuticals as a company in spite of our share price being challenged continuously in the market.
At the beginning of 2014, we were a platform technology company with a proprietary transformational technology applied to RNAi therapy and one product from that platform, RXI-109 in early clinical testing.
At the end of this past year, 2014, RXi Pharmaceuticals had grown into a mid-stage clinical development company with a powerful self delivering as the rxRNA platform, an active preclinical product pipeline in both dermatology and ophthalmology and with the addition of Samcyprone which is a newly acquired Phase 2 clinical compound in the field of topical immunotherapy.
In terms of RXi share ownership, 2014 marked the beginning of a major shift in the share ownership structure. At the beginning of 2014, still 70% of the company was owned by the two original hedge funds that had financed the spin-out from Galena.
As mentioned before, the funds received preferred shares and also in dividends at an annual rate of 7% and those dividends are paid quarterly in additional shares of preferred stock. The number of RXi common shares outstanding in January 2014 was about $12 million. We ended the year 2014 with 22 million common shares outstanding.
The vast majority of these new common shares were the result of conversions of preferred shares into common shares by th is one hedge fund that was left.
As we have said in our Form 10-K filed today, and I'm sure you have been able to read it, this conversion of preferred shares into common shares has continued in the first quarter of 2015 with an additional 9 million common shares entering the public market.
This brings our total number of common shares outstanding at the end of March to about 31 million reducing the number of preferred shares held today to an ownership level of about 19% down from 70% 15 months ago. The increase in common shares by about 160% has played a closer role in the pressure on our share price during the past several months.
The silver lining in this evolution is that RXi and just with a much more diversified shareholder base and that the amount of new preferred share is being issued quarterly as a dividend to the original investor in the spin-out has dramatically diminished.
These also mean that RXi is well on the way to becoming a much more broadly run corporation with a diverse shareholder base which gives us hopes that our share price will make a turn.
Most recently we announced that we entered into an exclusive license agreement with MirImmune where they delay [ph] license or they license RXi as the RXRNA technology for use in developing innovative cell-based cancer immunotherapy.
This collaboration has the potential to result in novel, more effective and patient friendly cancer treatments that could be a significant step towards personalized medicines. We also announced the closing of the exclusive global licensing agreement to Samcyprone with Hapten Pharmaceuticals.
Under the terms of the license agreement, Hapten received a small one-time upfront cash payment of $100,000 and 200,000 shares of RXi common stock. Samcyprone is a proprietary immunomodulator directly in Phase 2a clinical trials for the treatment of alopecia areata, warts and cutaneous metastasis or malignant melanoma.
Both of these collaborations marked the latest milestones for the company to partner and collaborate with industry to provide new and innovative therapeutics while also providing the potential for long terms financial returns for our shareholders.
The company's robust pipeline coupled with an extensive patent portfolio that is growing every year provides for broadest and business development opportunities across a broad spectrum and we look forward to advancing our further developing strategic areas of interest with other companies in the industry.
We realize that some of our investors have uncertainties about the status of our primary clinical development program with RXI-109. Now Dr. Pavco will be providing an overview of our research and development efforts during 2010.
She will also discuss the status of our clinical trials findings today and more importantly how these results have shaped continuation of our clinical development strategy. But first of all, I would like to turn it over to Ms. Kontulis for the discussion of our 2014 financials.
Caitlin?.
Thank you, Geert. The company's Form 10-K was filed with the SEC today and includes detailed information on the company's financial performance in 2014. In the call today, we'll focus on the highlights.
Research and development expenses for the fourth quarter of 2014 were $1.6 million and $5.7 million for the full year as compared with $1.4 million for the fourth quarter of 2013 and $17.7 million for the full year of 2013. Fourth quarter R&D expenses were consistent with those in the fourth quarter of the prior year.
The decrease in R&D expenses year-over-year was due to the one-time charge of approximately $12.3 million in the first quarter of 2013 related to the acquisition of RNAi assets from OPKO Health in exchange for shares of common stock of the company.
General and administrative expenses for the fourth quarter of 2014 were $0.8 million and $3.2 million for the full year of 2014 as compared with $1.1 million for the fourth quarter of 2013 and $3.7 million for the full year of 2013.
The company's G&A expenses decreased in both periods due to a reduction in the number of transactions that required outside professional services in 2014 as compared to 2013, such as the company's completion of our reverse stock split and our announced adverse payment [ph] obligations as well as a decrease in the company's Delaware franchise tax as a result of the reduction of the company's authorized common shares which was approved by shareholders at the company's most recent annual meeting.
Net loss attributable to common stockholders for the fourth quarter of 2014 was $2.8 million and $12.9 million for the full year as compared to $3.7 million for the fourth quarter of 2013 and $29.5 million for the full year of 2013.
The decrease in net loss attributable to common stockholders quarter-over-quarter and year-over-year was driven by the decreases discussed in our R&D and G&A expenses most notably a year-over-year decrease primarily related to the one-time charge of $12.3 million in 2013 related to the acquisition of RNAi assets from OPKO.
Additionally, there have been decreases in the fair value of our preferred share dividend due to changes in the company's closing common stock price on the dividend payment date and the number of preferred shares earning dividends both of which are calculated on a quarterly basis.
At December 31, 2014 we had available cash of $8.5 million compared with $14.4 million at December 31, 2013. During December of last year, the company executed a purchase agreement with Lincoln Park Capital which provided the company with excess of up to $10.8 million in funding.
With our current cash and the funds available under the LPC purchase agreement we expect that we will have sufficient funding to support our operations including our current and planned clinical trials for at least 12 months. More detailed information can be found on the Form 10-K filed with the SEC today. With that, I will turn the call over to Dr.
Pavco, who will discuss the company’s dermatology and Ocular programs..
Thank you, Caitlin. For the next few minutes I will give you an overview of our research and development programs at RXi. As you may know, the focus of the Phase 2a trial is the determined dose treatment and duration.
To this end we have initiated three Phase 2a trials in which we are evaluating the effect of RXI-109 treatment on scar formation or keloid recurrence following revision surgery.
The number of doses and dose levels that you can use in your initial clinical trials are based on the safety parameters determined for your drug gathered in your IND supporting toxicity studies. For the first two Phase 2 studies we limited the number of doses to the number tested in our original GLP toxicology studies.
As we have now gained more safety experience with RXI-109 in human by the intradermal route, we have been able to increase number of doses given. As I will explain later, this allows us to dose for a longer duration during which scar or keloid formation is known to occur and may result in a more lasting or robust effect.
We have completed enrollment in our first Phase 2a study 1301 and have already reported on the early learnings from these preliminary data.
Study 1301 was designed such that each subject had revision surgery to remove a hypertrophic scar and following the surgery one side of the revised area was treated with RXI-109, one side was treated with placebo and the central region was left untreated.
Three treatments with RXI-109 were given over two weeks either starting on the day of the revision surgery or two weeks later. Opinions from a panel of reviewers comparing photographs of the revised areas were collected and then summarized as to whether one side or the other looks better or if there was no difference.
These data were clear in that the reviewer selected the RXI-109 treated side as being significantly more often better if the treatment was initiated two weeks after the surgery rather and then immediately on the day of surgery.
The 109 treated sites showed a sustained benefit of RXI-109 after the three-month time point even though treatment was complete by month one. These results did exactly with what is known about the time course of wound healing and hypertrophic scar formation.
The proliferation phase of normal wound healing, which is the phase in which collagenase synthesized and laid down is extended significantly for hypertrophic scars versus during normal wound healing.
So it makes sense to treating further into this space of wound healing would have a more profound effect at reducing the formation of a scar which is primarily made up of collagen. Thus the consensus from the panel was that continuing treatment further into the proliferation phase would be of even more benefit.
Dosing is complete in study 1301 and the subjects will be followed until the last subject reaches a nine-month visit which occurs near the end of 2015.
Because we took a preliminary look at the early data in this study we were able to fine-tune the study design of the subsequent Phase 2a trial and to implement these improvements in November of 2014 long before study 1301 is complete.
So, based on the learnings from study 1301 we made a number of changes to optimize the dosing regimen for the next study in hypertrophic scars which is called study 1402. First of all we are initiating the dosing period two weeks after the revision surgery and the timing that was found to be best in study 1301.
Secondly, because RXI-109 treatment is so well tolerated we were also able to increase a number of dosing occasions from three to six in order to dose further into the extended proliferation phase of hypertrophic scaring.
The dosing schedule in study 1402 is weekly for four weeks so that the initial timing is similar to that in study 1301, but with four weekly doses instead of three and additional doses are also given at month two and month three. This effectively extends the dosing period from one month in study 1301 to three months in study 1402.
The second study in hypertrophic scars is a bit easier to enroll because we are allowing smaller hypertrophic scars on various parts of the body rather than requiring one long hypertrophic scar on the abdomen. The study is approximately 50% enrolled with subjects continuing to be added on a rolling basis.
We expect the study to be fully enrolled this year and we also expect to be able to report on early readouts from the study by year end. As we have announced RXi has also initiated a pilot study of using RXI-109 to reduce the recurrence of keloids after their removal. This Phase 2a study is study 1401.
Keloids are even more aggressive scars in hypertrophic scars and can continue to grow or spread for months to years. As with hypertrophic scars there are no FDA approved therapies for keloid disorder. Enrollment in study 1401 was complete in early March 2015 and we are continuing to follow the subjects through six months.
In this study, two similarly sized and placed keloids were excised and one excision site was treated with RXI-109, the other with placebo. Four weekly doses were given initiating either on the day of surgery or two weeks later.
Study 1401 provided an opportunity to look at early time points following revision and treatment much like our original hypertrophic scar study did. We took advantage of this and held a clinical advisory board meeting to discuss preliminary results from a sub-set of our subjects who had completed treatment and who are still being followed.
The clinicians on our advisory board were either practicing dermatologists or plastic surgeons. We happened to a blinded review of photograph of the keloid revision sites and asked them to respond as to which side seemed to recover faster. In line with the aggressive nature of keloid growth, keloids were recurring at both revision sites.
However, there was a tendency for the panel to select sites treated with RXI-109 as those recurring at a slower rate. Even with only a short treatment phase and regardless of the timing of the four doses.
Overall, the advisors were unanimous in their endorsement to continue evaluation of RXI-109 as the treatment to reduce keloid growth and they gave guidance on their next steps and the design of a follow-on trial.
Based on these discussions our next keloid trial is being planned to include more doses so that the treatment will continue from months longer into the proliferation phase of keloid growth.
The timing we are planning is similar to the standard of care currently done for keloid treatment, which is an initial course of steroid injections followed by maintenance injections as needed.
Now, steroid injection softens the keloid tissue and may shrink the keloid short term, but the aggressive keloids often grow back, so there has been limited therapeutic success.
Based on our early observations in our keloid study, we and our advisors believe keloid excision followed by RXI-109 treatment to block the keloid from re-growing will be more effective.
In addition to evaluating RXI-109 for the prevention of dermal scars and keloids, we are also moving toward a clinical trial in which RXI-109 is dosed by an intraocular injection to determine if direct delivery to the eye could prevent scaring of the retina.
To support this, a GLP toxicity study has been conducted with RXI-109 using intraocular injection as the route of administration. This study is a multi-dose study and it is our intent to go directly to a multi-dose clinical study rather than starting with the single dose study in the clinic.
Our general clinical plan was provided to the FDA at the time of our pre IND meeting and the agency communicated that they were in agreement with our plan. The samples from GLP ocular tox study are available now and the data are currently being collected and analyzed.
If you remember, similar samples from a pilot ocular tox study clearly showed that RXI-109 could reduce CTGF protein in the monkey retina. These data provided us with the demonstration of efficacy in an eye much more similar in size to human than our original studies in rodent eye.
We are on track to file an IND for the use of RXI-109 via the intraocular route by mid 2015. If allowed by the FDA, our first trial in ophthalmology will be in patients with severe neovascular age-related macular degeneration.
This disease is currently treated with anti-VEGF therapies to block the vascular endothelial growth factor from causing blood vessel leakiness and the subsequent damage to the retina. However, as the disease progresses, patients can also experience retinal scaring which leads to further vision loss.
It is our goal to block the scaring that is secondary to the vascular disease and in doing so preserve vision for a longer time. As I mentioned we are on track to file the IND to support this in the middle of the year and plan to start a trial as soon as possible thereafter.
I also want to mention two of the discovery targets that we are currently evaluating. For both targets, which are Collagenase and Tyrosinase compound optimization work has resulted in sd-rxRNA compounds with substantial improvement in potency over the compounds selected from the original screening work.
For Collagenase, experiments in culture cells have shown a very nice correlation between the dose response curves of silencing the miRNA for collagenase and the corresponding reduction in enzyme activity. This work confirms that the reduction in collagenase activity is the result of RNA interference, the expected mechanism of action.
Because collagenase is involved in breakdown of extracellular matrix specifically by degrading collagen a compound that reduces it has the potential this should be therapeutically beneficial for the treatment of ageing and blistering skin disorders, acne scaring, corneal erosions and even osteo and rheumatoid arthritis.
For our second discovery target Tyrosinase, optimized compounds are being evaluated in a three dimensional tissue system based on melena sites and their ability to reduce melanin is being measured. In this tissue system the sd-rxRNAs are able to inhibit melanin production by silencing tyrosinase resulted in visibly lighter 3D tissues.
An anti-Tyrosinase compound could play a therapeutic role in several hyperpigmentation skin disorders as well as in retinitis pigmentosa and a number of neurologic diseases.
To support the potential clinical use of the skin disorder related sd-rxRNAs several research collaborations are being pursued to evaluate the possibility of topical delivery that would eliminate the need for intradermal injections currently used in our dermal clinical trials with RXI-109.
Topical delivery for these types of skin disorders are to treat following hypertrophic scar of keloid revision would be a great advancement for the use of sd-rxRNAs for the skin. Topical delivery for the disorders of the cornea are also being evaluated.
These collaborations are in the very early stages to determine feasibility and proof-of-concept, but we will be able to report on update as we move further along. Lastly, I would like to mention our new Phase 2 compound Samcyprone. Samcyprone is the propietary topical formulation of diphenylcyclopropenone or more simply DPCP.
DPCP is an immunomodulating agent that works by eliciting a T-cell response. It has been used for over 20 years to treat warts and alopecia areata and has shown efficacy against cutaneous metastases of melanoma as well.
In December of last year we licensed a topical formulation of DPCP which is known as Samcyprone from Hapten Pharmaceuticals and in doing so we obtained patents and additional IND and the rights to conduct clinical trials with this topical formulation.
While the drug DPCP has been used for decades it is expected that this new formulation will result in a better safety profile in more consistent drug product and equivalent efficacy at lower doses.
We are very excited to bring this compound into the company and to support the ongoing investigator sponsored clinical trials in cutaneous metastases of melanoma as well as a new investigator sponsored clinical trial in alopecia areata. In addition, we plan to initiate a Phase 2a clinical trial in warts for Samcyprone by the end of this year.
I will now turn the call over back to Geert..
Thank you, Pam. I would like to take a few moments to recap a few highlights about our clinical trials program with RXI-109. In phase one in 2013 we gathered safety data and learned about efficacy based on biomarkers improving the RNAi mechanism of action of our RXI-109 in humans.
In our initial Phase 2 trials it is important to note that the dosing regimen was limited to three or four doses over a very short period of time two to four weeks.
Those significant side effects or toxicity have been observed in the clinic providing us with the information to prolong dosing in those two indications and the duration in an adequately justified manner.
In Phase 2 we learned that it is better to initiate dosing two weeks post surgery for hypertrophic scar revisions and we also learned that we need to treat longer into the proliferation phase of wound healing in order to block the continued production of collagen.
In the keloid study, longer dosing is required to achieve long-term clinical benefits as well. In summary, we believe we are well positioned for a successful 2015. The overhang from the preferred shares have been substantial reduced and as a result obtained a broadening and diversification of our shareholder base.
We have shown that our lead drug RXI-109 works in the target population and we are on track for continued clinical development in dermatology and ophthalmology with this compound.
We expanded our clinical pipeline with an additional Phase 2 agent [ph] Samcyprone, which is today not a drug, although it has been used a lot, but which would become a first time approval with the associated exclusivity.
And we have out licensed our sd technology for development for cell-base cancer immunotherapy a potential step towards personalized medicine. Thank you all for your time and I would like to return the call now to Ms. McGrillen..
Thank you, Geert. This concludes the formal presentation. Operator, may we please poll for questions..
Certainly. The floor is now open for questions. [Operator Instructions] Okay, and our first question comes from Keith Markey of Griffin Securities..
Hi, thank you for taking my question.
I was wondering if you maybe could tell us whether you expect further selling by the major investor that you have remaining this year?.
So what we expect the major investor to do?.
Yes..
Well, of course, we are part of this run, so it’s sort of difficult to say, but I would basically today the major investor has about 6 to 7.3 million shares left.
And so what we expect them to do is possibly stay with this amount, yes, and not to give any indications what you would, so would do, it could be that he continues to sell which is in reality not a major issue.
It seems it would only probably would continue to put pressure on our share price, but it would further reduce his position and in the medium term I mean in a few months I would expect that our share price is going to react to the fact that there is a major overhang that has been and that is gone.
We are actually coming to the point that we are really a publically traded company..
I would imagine that his current holding would be something that he would want to stay with. Thank you.
And I was just wondering, Pam mentioned that there was topical delivery system being investigated for the tyrosinase and collagenase drugs and possibly for the ophthalmic indication, but I was wondering is it possible to develop one for the RXI-109 for dermatological scaring, not necessarily obviously well not to be applied during the surgical procedure, but afterwards by the patient even?.
Hi, Keith. Yes, it is likely that whatever formulation will be developed for either tyrosinase or collagenase could be adapted to use for the RXI-109 for scaring.
You are right in that we may want to do intradermal injections as the initial part of the treatment and then potentially to some sort of delivery later that would be more patient friendly and maybe even allow the patient to do their own treatments at home, but that’s obviously a long-term goal..
Right, right, okay.
And then I was just wondering if you might elaborate a little bit on the MirImmune deal, I understand that it involves checkpoint inhibitors and I just wondered if you could give us a little bit more information about them and also what sort of timing here you are thinking of in terms of the collaboration moving forward to pre-clinical development anyway?.
Well, first of all let me clarify that we ourselves are not going to be involved in cell based treatment, so we stick to the conventional way of administering drugs. It is totally different set-up. It would be a totally different approach.
It is some approach we are absolutely endorsed because our sd-rxRNA platform and that’s also been mentioned by the MirImmune team after they looked at a number of platforms clearly comes up as the most desirable for cell-therapy because you can pretty much harvest the cells from the patients.
So with all the cells you can put them in a culture medium and you just add sd-rxRNA saline not in fancy vehicles that may actually cause some damage and cell loss. Our saline just gets sucked up by the cells and we would love to see that progress. They are eager to get started as quickly as possible.
I know that they work on a contract basis with a lab. We also know we are enough to do some of the work, I have been told that they have prepared some of their work to get started and I am sure that we will be stay updated on what they are doing. But we think it is an exciting development for our technology platform.
We think that it is possibly going to result in major value appreciation of the company because over time we are allowed to get double-digit equity per position that is perfect against solution into that company as they become successful and that is for basically a normal fee of $1, so that’s definitely a good deal..
Yes, it sounds like a great one, especially in the field of house, of immunotherapies, thank you very much. I will step out for now..
Thank you, Keith..
Thank you, Keith. Operator, we may, the next call, is there is another one in the queue..
Yes, we do have a question from Reni Benjamin of H.C. Wainwright & Co..
Hi, good afternoon guys, thanks for taking the questions.
I guess just a couple may be starting off with RXI-109, can you talk a little bit about how we should be looking at this product as compared to Pfizer’s Excaliard product, you know is the dosing that you have now learned from 109 is that comparable to Excaliard’s dosing as well, or is there you know some sort of difference there? And I guess related to that, from the data that we do know both in Excaliard’s and Pfizer's product as well as 109 is there any differentiating aspects between the two molecules that we should be aware off?.
Yeah, okay. Of course, we don’t know what Pfizer is doing or has been doing with the Excaliard product. What we do know is that the protocols that they were using was a very strict rigid protocol looking at primary endpoint one year after the surgery for each patient that is why the study took about three years I think to readout.
We have tried to avoid that by basically going into Phase 2 with doses and the treatments legs that we could afford with the toxicology data that we have and hence we have seen these doses were well tolerated we have been able to then gradually develop protocols that will take us as longer.
They have treated up to three months and up to three months from the pictures we have seen because I have already seen what most of the public has seen that product works fine at three months.
The fact that they didn’t reach their primary endpoint at one year makes me think that the significance there at three months may not have held up properly, but that is pure speculation of course on our side, but that is when we have decided and talking to our investigators some of them who have been working with the Excaliard product as well that we should treat longer into the proliferation phase to get much more sustainable clinical effect even at later stages by treating longer.
And I can maybe hand it over to Pam to explain or mention what we are doing in the current protocols to achieve that..
So, I would just add that we built into our protocols the ability to look at the early readouts so that we could learn very early information about how to optimize dosing and dose level, timing and dose level for a next study.
So because of that that is really helped us learn from our first study 1301 to be able to design our second study in hypertrophic scars with additional dosing and in particular also waiting until two weeks after the initial surgery. So, we were able to learn very quickly how to move forward rather than waiting to the end of the study.
So, I think by being doing smaller adapted studies we have been able to address some of the issues that might have come up and we will obviously continue to do that as we move forward.
The information we learned in hypertrophic scar studies so that we could move into the second one we are combining that also with what we are learning in the keloid study to design better and more optimal dosing regimen for keloids and that’s another study that will be moving forward with as well.
So, I think that’s primarily why we did the smaller more adaptive studies to start..
And I guess just relating to the new dosing protocol that’s been selected you know how do you guys come up with let’s say the four weekly doses and then switching to monthly, was that more decided for patients comfort and compliance or did you somehow have some insight that you after four weeks you no longer have to maintain a weekly injection?.
That’s a really good question. We do know that RXI-109 is maintained in the skin in animals anyway for at least a week or so. And so we wanted to make sure that we initially got enough drug onboard in order to stop that first, I don’t want to call it ex-financial but that first burst to CTGF.
And then because and then move to more maintenance dose that would be more palatable to the patient. Because we are able to look at small groups of patients with this type of dosing we may been learned that we can either spread the dosing out more or you know there is a variety of different ways we can go.
We haven’t settled on what we are going to do for the keloid trial and one option we are considering there, because that’s an more aggressive the scar is to do weekly dosing at first and then switch to bi-weekly, or every other week or something like that.
So, obviously we are still in the planning stages for that trial based on what we learned with our advisors and by having them review some pictures, but those types of options are being discussed..
Okay, and just relating to the advisors and sort of the qualitative data you guys have been able to provide with the physician remarks, is there any way to make that those qualitative remarks more quantitative going forward as data comes to us?.
Yes, yes, as a matter of fact there is, so we’ve look only at very initial subjects that are in the trial and obviously they are moving through the trial and we need to get to it to the total of 20 before we have all of the data collected.
However, because we are taking photographs along the way we will be able to do some measurements from those photographs. We in particular are using 3D imaging so that we should be able to not just get a length and width, but also a volume of the keloid.
And that will be very important to be able to tell the difference between for example a keloid that is growing very slow versus one that is growing very fast.
And I think that that data are going to be very telling, but obviously we can’t do that until we really get further into the study and get to the end of the study, but that we put a number on it, not just an objective, yeah, I think this is doing better than that one..
Got it.
And just, I guess related to that, upcoming data presentations, do you have any coming up at, I'll say some dermatology conferences or anything in the next six to 12 months?.
We are presenting at the World Congress of Dermatology in June and that will just be an update on all of the three trials that we have going on right now..
Okay, do you think we might have some of that volume measurements by that time?.
I do not think we will have them by June, because we want to make sure we get enough, actually I prefer to go and have all the subjects reach a particular point before we do a round of measurements, so that we are not just looking at part of the data for that..
Got it, okay..
We also have a couple of presentations at the Society for Investigative Dermatology which is coming up in, when is that?.
May..
May, in May..
And these are all 109, correct?.
Yes, that’s all 109..
And for Samcyprone..
And Samcyprone, okay, great.
And just related to just switching gears to the MirImmune partnership, can you just tells us these cell therapies, I guess what exactly, how we should be thinking about this platform? Is it cell therapies to induce an immunological response, is it more, you know kind of T-cell engineered cell therapies, you know where you will be using the sRNA to knockout genes within those cells, how should we be thinking about the programs?.
So, again first, and again they are doing the work we have been asking them what they were going to do. They are interested in checkpoint inhibitors in the sense that checkpoint inhibitors boundary are approaching that are regulated and grows resistance to chemotherapy.
And they would be looking for self-delivering RNAs at to actually lower dose resistance levels true cellular therapy, so basically treat the immune cells but not the natural grow the cells, inject them back into the patient and see if they can beneficially affect chemotherapy..
And do you know when they might be entering the clinic?.
Entering the clinic, I understand that entering the clinic is lot faster in cell therapy than in conventional therapy. But they have not laid out their plans yet. I am sure that we will learn more about it that actually progress. I may not be able to talk about it, actually I know I will observe to see them.
They may not be prepared to just have me talk about it without them for us being able to talk about it themselves..
Fair enough, fair enough, just one last question from me.
The burn rate for 2015, how should we be thinking about it as these clinical trials begin and new ones are initiated?.
So, in the past year our burn rate was consistently in the $2 million to the $2.5 million range per quarter. And as we move forward with our current trials and our planned trials we expect this to move closer to the $2.5 million to $3 million range per quarter..
Thanks, very much. Good luck in 2015..
Thank you..
Thanks, Reni..
Thank you, Ren. Operator, we are ready to take one final question..
[Operator Instructions] Okay, we do have a question, it’s from Andrew (ph) [indiscernible]..
Hi, everyone, how are you today..
Fine, thank you..
How are you?.
Good.
Just the question I would have is, is there an expectation for a date for six months photos as well as just more consistent communication overtime given the fact that over the past 13 months we have obviously been punished as stockholders and just trying to counteract may be some of the social media impact which you've addressed before?.
So, I can answer that a bit, in most cases you wait to the end of the study for companies to report out at all, that happens quite often. Because we do the adaptive protocols we were able to show one and three months data after such as short dosing period.
And in essence we saw what we, we sort of reached our goal and that was to determine whether we have the optimal dosing regimen or whether we needed to make some changes.
So by seeing that early on, we did see that we needed to dose longer and we don't expect to see a big difference between treated and placebo as time goes on because we only treated for a very short period of time.
So we're still for 1301 we're completing that trial and the final trial results will include six and nine months photos and any comparisons that we do.
The last subject in that trial will reach nine months in the late Q3 and then we want to do a full comparison of data and final report and the all parts will go into a data base before we report out on that. However, if we do have key findings before then, we would plan on presenting those..
May be I can add a little bit to that in the sense that when we look at some of the six months for those already, there is actually in the number of patients we can still notice a difference between the treated and the placebo treated side.
But it is clear that the difference is becoming smaller and smaller and that is actually one of the things that we're going to try to work on with those volumetric the 3 dimensional measurements because it might give us an indication of how long we will have to treat in order to be able to add one year after the revision surgery, still a significant difference between active and placebo which is the primary endpoint one year after revision surgery from a regulatory point of view at this stage..
It is more of the disaster recovery over the past 13 months that I was looking for more information on just if we see the slip more and more, is there going to be a time where there could be some sort of reassurance go out to the masses that are there on site or at least going on the right track?.
Oh, it is a fair question, but I assume you talk about the disaster recovery in terms of the share price because there is no need for disaster recovery with RXI-109.
Contrary to what some people seem to believe, we are very much convinced that and our investigators tell us, that this drug works, that is just a matter of declassifying it as a miracle drug that would do it with injections and use it as a normal drug.
And as far as the share price is concerned, I can only imagine that selling by all that we purchased which many people have not put into the equation although it was from the get-go in all the documents that have been filed with the SEC.
When the dividend, level of dividend that we have to give in preferred shares goes down with the overhang of the preferred shares disappearing and those shares being picked up by other funds as common shares so that they can participate and you've seen the effect on the volume of the training volume everyday that we will come back to normal.
There is fundamentally nothing wrong with company. On the contrary, we have been doing pretty well moving along and I am not talking about share price. I am talking about our evolution it is a matter of time for the hangover to the end of the, the overhang not a hangover, the overhand to disappear and the share prices have to recover.
If I compare our market value on a fully diluted basis with our peers, others and our company that are in the similar stages that we are or actually one of them is still earlier than we are and I look at our market GAAP pricing there is substantial potential for upside value here..
And doctor, we agree it is more for the masses that do agree with you that fundamentally the business is strong. It is the share price like what you had said that's really taken a beating over the past 13 months.
When is time going to be done selling off what they are going to sell off and when can we feel comfortable that they are done doing what they are doing and we can really see the light at the end of the tunnel?.
Well, I can only say that I have no control over [indiscernible] capital I could spend at least I take linearly what he has done in the first three months them as he continues them three from now we will be out of preferred shares because he sold $9 million in the first quarter and he only had $7.3 left as far as I can count.
But if the past is any indication in terms of how management states they usually tend to keep some portion of their investment on for a long term basis. I just don’t know how much that portion is and still I cannot speculate.
I think I've seen the end of the tunnel already and by the way I continue buying because guarantee of course in a blackout, but I continue buying and look, I know the ins and the outs of the company and we are doing perfectly okay today except for the share price..
Okay, thank you..
Thank you for being a shareholder..
And at this time we have no further questions..
Thank you, Andrew. That concludes our call for today. Thank you everybody for joining the call..