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RXi Pharmaceuticals Corp.


RXi Pharmaceuticals Corp. is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, next-generation RNAi platform. Therapeutics that use RNA interference, or "RNAi," have great promise because of their ability to "silence," or down-regulate, the expression of a specific gene that may be overexpressed in a disease condition. RXi's first RNAi product candidate, RXI-109, is currently in clinical trials. It targets connective tissue growth factor, a key regulatory of fibrosis and scar formation, and is initially being developed to reduce or inhibit scar formation in the skin following surgery.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Reni Benjamin, H.C. Wainwright & Co. (11/18/14) "We are reiterating our Buy rating of RXi Pharmaceuticals Corp. and a target price of $9. . .with a strong proprietary RNAi platform focused on dermal and ophthalmologic applications, a derisked lead asset with the potential to enter multiple therapeutic areas and a cash position of $10.1M, we believe the company represents an undervalued player with significant upside for the long-term investor."

Edward White, Laidlaw & Company (10/8/14) "The Phase 2a photos of hypertrophic scar patients treated with RXi Pharmaceuticals Corp.'s RXI-109 following scar revision surgery presented yesterday showed significant improvement compared to placebo at three months, in our opinion. . .we are maintaining our Buy rating and price target. Our price target for the company is $8."

The Life Sciences Report Interview with Keith Markey (10/8/14) "RXi Pharmaceuticals Corp. has done extensive clinical trials and/or extensive research both at preclinical and clinical levels with its lead molecule, which targets a growth factor called connective tissue growth factor that plays a central role in the formation of scars. . .the company is developing products that are relatively easy to administer to the specific areas that need to be treated. By that I mean dermatological indications, which are very easily accessible, and also the eye, for ophthalmic diseases. That's RXi's way of mitigating some of the risk from the delivery point of view. Its molecules also are designed specifically to facilitate the uptake of their therapeutic payload, so that's not an issue that has to be considered separately. . .the [Phase 2] trial was designed to optimize the treatment regimen, and the one-month data did just that—the first interim analysis showed that a delayed administration of RXI-109 yielded better results than injection near the time of the surgery. . . More >

Reni Benjamin, H.C. Wainwright & Co. (9/11/14) "Yesterday, RXi Pharmaceuticals Corp.'s preliminary, one-month data from the first trial, focusing on lower abdominal hypertrophic scar revision, included statistically significant (p<0.001) improvement in one of two patient cohorts relative to a placebo control. . .because the study protocol includes an adaptive design, we believe these early clinical observations are critical for provide a clear path forward to optimize treatment schedules in additional cohorts, thereby boosting the chances of success for the entire program."

Edward White, Laidlaw & Company (9/11/14) "Yesterday, RXi Pharmaceuticals Corp. announced one-month interim data from two cohorts of its Phase 2a RXI-109-1301 study in patients with lower abdominal hypertrophic scars. . .given the physiology of wound healing and the significant data for the second cohort, we have increased confidence in the ultimate success of the 1301 study as the remainder of the trial will administer new patients delayed dose of the drug (first dose at t+14 days) following surgery. We view this early decision to restructure the cohorts as a strong positive."

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Edward White, Laidlaw & Company (9/3/14) "RXi Pharmaceuticals Corp. is expected to have preliminary data from the first of three Phase 2a trials (RXI-109-1301) by the end of September. . .we continue to forecast preliminary data for the second program (RXI-109-1401), with expected enrollment of 16 patients undergoing keloidectomy (keloid scar removal), by the end of December 2014. The third study (RXI-109-1402), which the company announced was initiated on July 30, 2014, is projected to have preliminary data by mid-2015."

Reni Benjamin, H.C. Wainwright & Co. (8/15/14) "We are reiterating our Buy rating of RXi Pharmaceuticals Corp. and a target price of $9. . .the company has three Phase 2 clinical studies ongoing with the potential to report preliminary data in hypertrophic scarring and earlobe keloids over the next four to six months."

Reni Benjamin, H.C. Wainwright & Co. (7/31/14) "Importantly, RXi Pharmaceuticals Corp. has initiated a third Phase 2a clinical trial for the reduction of recurrence of hypertrophic scars that can occur after surgery, which we view as good news for investors as the company continues to execute on its multipronged clinical development strategy. With a strong proprietary platform technology focused on anti-scarring and ophthalmic applications, a derisked lead asset with the potential to enter multiple therapeutic areas and a cash position of $11.5M (pro forma), we believe RXi represents an undervalued player in the RNA interference space with significant upside for the long-term investor."

Edward White, Laidlaw & Company (7/30/14) "This morning, RXi Pharmaceuticals announced the initiation of the third of three planned Phase 2a studies of RXI-109 for the treatment of hypertrophic scars following scar revision surgery. We are maintaining our Buy rating. . .our price target for the company is $8, which is based on the NPV of our probability-adjusted forecasts for RXI-109 and a small value for RXi's preclinical pipeline."

The Life Sciences Report Interview with Reni Benjamin (7/10/14) "RXi Pharmaceuticals Corp. is one of several companies using RNA interference (RNAi) as a platform, and trying to develop therapies for indications not being addressed by competitors. . .RXi is relatively new in this space. It is targeting the processes involved in scarring and fibrosis. We feel the company has largely been ignored by investors, but has potential. . .RXi has Phase 2a data coming out in Q3/14 that would validate its platform, its agent RXI-109, and its gene target CTGF (which expresses the protein connective tissue growth factor [CTGF]).

Scarring is a multibillion-dollar market, primarily in the hypertrophic scarring and keloid areas. . .The initial RXi data should give us enough information to ascertain whether the product can move forward, and whether or not RXi could be a potential acquisition target. These data, if positive, should lead to some significant valuation increase. . ." More >

Edward White, Laidlaw & Company (6/2/14) "We are initiating coverage on RXi Pharmaceuticals Corp. with a Buy rating and a price target of $8. We believe that the company's innovative RNAi-targeted technologies can address large markets that can potentially generate substantial revenues."

Reni Benjamin, H.C. Wainwright & Co. (5/16/14) "We are reiterating our Buy rating of RXi Pharmaceuticals Corp. and a target price of $9. . .with a strong proprietary platform technology focused on anti-scarring and ophthalmologic applications, a derisked lead asset with the potential to enter multiple therapeutic areas and a cash position of $14M (pro forma), we believe the company represents an undervalued player with significant upside for the long-term investor."

Reni Benjamin, H.C. Wainwright & Co. (5/5/14) "We are initiating coverage of RXi Pharmaceuticals Corp. with a Buy rating and a target price of $9. . .with a strong proprietary platform technology focused on areas of unmet medical need, a derisked lead asset with the potential to enter multiple therapeutic areas and a cash position of $14M (pro forma), we believe the company represents an undervalued player with significant upside for the long-term investor."

The Life Sciences Report Interview with Keith Markey (4/10/14) "RXi Pharmaceuticals Corp. has some very important valuation-driving events in progress, including a couple of clinical trials currently underway. One is for use of its connective tissue growth factor (CTGF) gene-targeting agent, RXI-109. . .a small-interfering RNA (siRNA) molecule being tested as an adjunct to plastic surgery of the lower abdomen for scar revision. . .[the] patients are women who have had a hysterectomy or Cesarean section or abdominoplasty surgery that left a transverse scar of 11 cm in length or more. The other application [involves] surgical revision of keloids, another type of hypertrophic scar. . .

TLSR: These trials are designed so that each patient acts as her own control, with half the hypertrophic scar injected in the abdominal scar revision field, or just one ear injected in the case of a keloid excision. It's a sure way of eliminating age and genetic factors in a patient population and getting a true read on the efficacy of the drug. Was this design a top-management decision?

KM: Yes, it was. . .another smart decision will eliminate a drug-delivery problem we normally see with siRNA molecules when they are used systemically. . .RXI-109 is injected locally and visibly into the scar revision field exactly where you want it to act. . .this particular approach eliminates that delivery issue entirely. . . More >

The Life Sciences Report Interview with Reni Benjamin (12/12/13) "Other companies in the RNAi space include RXi Pharmaceuticals Corp. . . RXi is different, in that its compound's structure seems to attribute unique characteristics that facilitate delivery. It doesn't seem to have the need for a delivery molecule, and based on the preclinical work that the company has shown, its platform demonstrates robust entrance into the cell. . .RXi [is one of the] key players in the RNAi space that I think show significant promise. RXi is relatively new in the field, with a strong intellectual property position and a compound, RXI-109, currently being evaluated in a phase 2 trial as a post-surgical antiscarring agent. Data are expected in H1/14. We are agnostic, if you will, to the company's therapeutic focus, dermal scarring. What we do like about this indication is that it's topical. This oligo does not have to be injected systemically, with the hope that it gets to the scar area. From a clinical trial design point of view, this is a very intriguing indication.

"From a target perspective, RXi is going after connective tissue growth factor, which appears to be overexpressed in scarring and fibrotic diseases. The inhibition of that mRNA works very well with the mechanism of action of RNAi. From a clinical trial perspective and a science perspective, we think RXi has a lot going for it, and the company is not well known in the marketplace. It is a company that investors should definitely take a look at. . .the company is taking out one potential hurdle. Typical RNAi therapeutics are intended to be given systemically. They have the potential for degradation before ever getting into the target tissue, or there may be trouble getting enough drug to the target tissue. That is not the case with RXi's therapeutic." More >

The Life Sciences Report Interview with Craig C. Mello (11/21/13) "When we founded RXi Pharmaceuticals Corp., much of our thinking was directed at the problem of delivery. . .what we've done at RXi is modify the RNA itself to make it more druglike, which improves its ability to penetrate cell membranes. The result is spontaneous cellular uptake of sd-rxRNA without having to complex it into a large particle to get it into a cell. . .the platform basically allows the RNA to enter cells much more readily than would a typical siRNA. In fact, the uptake is really striking. Within minutes, you can see cells exhibiting substantial uptake of a fluorescently labeled sd-rxRNA, whereas a control RNA, without sd-rxRNA properties, would basically just not get into the cell at all. . .when you put sd-rxRNA on cells, it gets into them very rapidly. A good percentage of the self-delivering molecules will then enter the cellular machinery and begin searching for targets and silencing them. In my opinion, it's probably one of the best, if not the best, self-delivering RNAi platform that's out there." More >

Biotech Pick List, Seeking Alpha (10/14/13) "Rxi Pharmaceuticals Corp. presents a huge opportunity for investors, because in my opinion it is severely undervalued. . .the low share price along with the low float presents a huge opportunity for long term investors to get on board. There are still plenty of catalysts to cause a huge upside move in the stock price."

The Life Sciences Report Interview with Keith Markey (9/12/13) "I am quite pleased with the performance of RXi Pharmaceuticals Corp. . .RXi Pharmaceuticals has a presence in the small interfering RNA (siRNA) space for tissue scarring. . .the goal is to develop an antiscarring drug for multiple applications. More recently, RXi expanded its product portfolio by acquiring siRNA intellectual property (IP) around vascular endothelial growth factor (VEGF), which could be used in combination with the CTGF siRNA therapy for ophthalmic purposes. The company has also begun working with an academic scientist on a project that addresses retinoblastoma. RXi is doing very well. It has enough cash to carry it forward for at least another 12 months. Data from phase 2 clinical trials for its dermatology product should take the company comfortably to the next inflection point. We could see a nice rise in the stock over the next 12 months as the data arrives in stages." More >

Keith Markey, Griffin Securities (8/7/13) "RXi Pharmaceuticals Corp. has a well-defined road to the future. . .strong scientific evidence underpins the use of RXI-109 for dermal scarring. . .the company's creativity shines in the ophthalmology franchise. . .and it has sufficient capital to reach the next valuation inflection point. . .we reiterate our Buy recommendation."

Andrew McDonald, LifeSci Advisors (7/15/13) "RXi Pharmaceuticals Corp.'s second phase 1 trial confirmed the mechanism of action and a strong safety profile for RXI-109. . .and on June 19, RXi announced that its shares would begin trading on the most well regarded OTC Marketplace, OTCQX; the new listing gives an assurance to investors that RXi will meet certain financial standards, undergo management reviews and maintain transparent reporting standards. . .if RXi is able to continue executing on its development milestones and the compounds under development fulfill their promise, RXi investors will certainly reap the rewards many times over."

Andrew McDonald, LifeSci Advisors (6/11/13) "On June 6, RXi Pharmaceuticals Inc. announced the successful completion of its first phase 1 clinical trial for RXI-109, a proprietary anti-scarring, sd-rxRNA compound, providing initial validation for its technology platform. . .the results are very encouraging for this program and all potential uses of RXi's self-delivering technology platform."

Keith Markey, Griffin Securities (4/25/13) "RXi Pharmaceuticals Inc. management has crafted a well-conceived corporate strategy. . .the lead compound shows promise in an early clinical trial for disfiguring dermal scars. . .and investor support has provided a comfortable financial runway. The company recently completed an equity offering that resulted in about $20M cash on the balance sheet. We believe that will be sufficient to support operations into early 2015. . .we give RXi a Buy recommendation."

The Life Sciences Report Interview with Keith Markey (3/28/13) "RXi Pharmaceuticals Inc. has a unique pedigree. It was founded by Nobel laureate Craig Mello to commercialize small inhibitory RNA or siRNA. He was co-recipient of the 2006 Nobel Prize in Medicine for RNA interference (RNAi).

The company, over the years, has developed a self-delivery attachment to the RNA portion of a molecule that enables the RNA to get into the cell. That is a very important hurdle to overcome because, as most companies in the siRNA space will attest, getting an siRNA molecule into a cell is not the easiest thing to do. The other problem is getting it to the appropriate cell. I like the strategy RXi is pursuing at this point, which is to treat conditions that require only a local administration of its drug.

The company's lead siRNA is called RXI-109, which targets the expression of a cellular signal called connective tissue growth factor, which plays a crucial role in fibrosis. It is being tested to prevent scar formation dermatologically, and also for an ophthalmic condition called proliferative vitrealretinopathy (PVR), scar tissue formed in the eye when a patient has a retinal detachment. PVR occurs in 8–10% of patients who get a detached retina, so this would be an orphan indication and something the company would be happy to partner out. I think it would prefer to continue with dermatological applications internally for a while." More >

Andrew McDonald, LifeSci Advisors (3/7/13) "Under the terms of the agreement announced today, RXi Pharmaceuticals Corp. gains rights to OPKO Health Inc.'s portfolio of patents for RNAi therapeutics targeting a variety of biological targets. . .this transaction is a clear win for both RXi and OPKO, as RXi has greatly strengthened its intellectual property position while bringing promising targets for pharmaceutical development into its portfolio. . .the investment in RXi Pharmaceuticals by OPKO Health and Frost Gamma Investments Trust provides important validation for the development of RXI-109 in dermal scarring."

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