Cytodyn (CYDY) Research Report

Cytodyn (CYDY) Research Report 2016

Company Name: Cytodyn, Inc. 

Company Ticker: CYDY

Shares Outstanding:  118 million

Market Cap: 185 million

Current Share Price: $1.36

Most Recent Company Presentation For All Programs: June 2016:

Cytodyn Pro 140 Investor Presentation

Summary: Cytodyn is a biotechnology company working on improving patients lives with HIV. Current treatments out there are burdensome for patients who have to take anywhere from 1 to 7 pills per day for the entire week. The problem with this is that the current standard of care treatment options are toxic for patients. They produce side effects such as nausea, vomiting, liver damage, kidney damage, and a host of many other problems. Cytodyn is working on developing a monoclonal antibody that can be injected once a week for these HIV patients. This means similar or better efficacy to current HIV drugs but with less side effects.  The name of the monoclonal antibody is known as Pro 140 and it can be developed in other areas as well. The company is also pursing its additional target of Graft Versus Host Disease -- GvHD. 

Technology: The company's technology is known as Pro 140 and it is a monoclonal antibody that stops the first process of HIV from being able to replicate in cells in the body. In order for HIV to penetrate an immune cell in the body it has to attach to the CD4 receptor and the CCR5 receptor. Pro 140 acts by blocking the process of the CCR5 receptor, the second and final stage HIV needs to get into the immune cell. In other words the GP120 protein of the HIV must attach to the CCR5 to complete the process of entering the cell or else it can't replicate.The good part about Pro 140 though is that while it blocks HIV cells from the CCR5 receptor it still allows good cells, known as(chemokine) that regulate inflammation that need to get through, to get in okay. Other treatments that exist out there don't allow chemokine to get through. Below is a video that describes the process in better detail: 

Pro 140: How it Combats HIV

Cytodyn bought the Pro 140 drug from Progenics (PGNX) many years ago, back in 2012. Under the terms of the agreement Progenics received a $3.5 million payment from Cytodyn. In addition Cytodyn must pay milestone payments and royalties for the drug.

Pipeline Candidates:

Pro 140 HIV: HIV is a virus that attacks the body's immune system, making it vulnerable to other diseases. When the immune system becomes weak it is unable to fight off other infections making the HIV virus very dangerous. HIV replicates itself in helper T-cells in the body, and once replicated they continue to go after and invade other T-cells. Pro 140 is a monoclonal antibody that binds to the CCR5 co-receptor of a T-Cell. HIV needs to binds first to the CD4 receptor and then the CCR5 receptor to complete the process. Pro 140 stops the binding of the GP120 HIV protein and the CCR5 co-receptor. To put into simpler terms Pro 140 blocks the second step of the HIV entry process thereby stopping it completely.

 The HIV market is huge. Cytodyn is targeting HIV patients with the R5 strain. That accounts for 90% of newly diagnosed patients, and 70% of the overall HIV population. That is a big market, especially considering the two approaches the company is taking.

One approach is doing a combination trial of Pro140 together with HAART therapy (Standard of care for HIV). That is one phase 3 trial the company is running totaling 300 patients.

The second phase 3 trial the company is running is with Pro140 acting as a monotherapy drug. This trial is also enrolling 300 patients, but this time there will be no combo needed. The company wants to see if Pro140 alone can suppress viral load in these HIV patients. Thus far previous studies have shown 2+ years of viral suppression with Pro140 alone. The potential with that could be huge.

Pro140 + HAART therapy can command up to $5 billion market potential

Pro 140 Monotherapy can command up to $11 billion market potential

What must be remembered is that this market potential is only for the U.S. population. That doesn't include other global markets.

Cytoline: Like Pro 140 Cytoline is another monoclonal antibody the company has in its pipeline. For the time being it has pushed this back for a later time. Cytodyn is currently focused on the development of Pro 140 in both adjunct therapy and as a monotherapy. That's not to say that it won't ever be revisited, but if it does it will be at a much later time. 

Pro 140 Graft versus Host Disease -- is a type of complication that can occur after a surgery is performed. Such a surgery is either a stem cell or bone marrow transplant. Patients experience complications when the newly donated cells start to attack the patients own body.

Pro140 in GvHD is almost ready to start a phase 2 trial. It has currently not recruited any patient yet, but this is another shot on goal for the company.

Pro140 in this indication targets a $500 million market opportunity

Partnerships/Buyout:

There are currently no partnerships the company has accomplished, and no talks yet released about a buyout. Despite that investors should look for a good future here if Pro 140 pans out in the two phase 3 trials. There is no guarantee of a buyout or partnership but investors should understand that this biotechnology company is in a unique place compared to its peers. 

If Pro 140 is successful it could replace 1st line monotherapy or higher as a monotherapy and 2nd line therapy or higher as an adjunct therapy. That means that Gilead Sciences which is the leader in the HIV space stands to lose billions of dollars in yearly revenue if a competitor takes its space. With the results seen to date, Pro 140 has the ability to take Gilead's market share away if ultimately approved by the FDA. Why should Gilead want to acquire or partner with Cytodyn? 

1. Gilead stands to lose a lot of yearly HIV revenue if Pro 140 makes it to market

2. Pro 140 has less side effects than all other HIV medicine on the market 

3. Gilead can buy the company on the cheap between $2 billion and $5 billion and save itself from enormous losses

4. Pro 140 is a once a week injectable that accomplishes the same thing other drugs do without toxic side effects. Patients won't have to take a pill/pills everyday for the rest of their lives to achieve the same viral suppression. 

That puts investors with huge upside potential here, because if further results come out better than other HIV medicines it will force a big pharmaceutical to buy Cytodyn. Preferably sooner rather than later. 

If you take a look at a website known as Statista it highlights the market leader in the HIV market in terms of sales from 2009 to 20140 in the space which is clearly Gilead. 

Statista Top Aids drugs 2009-2014

Management:

Nader Z. Pourhassan, Ph.D President & CEO : Dr. Pourhassan became the company's Managing Director of Business Development in June 2011. Prior to that, he was the Chief Operating Officer from May 2008 to June 2011. Born in Tehran, Iran in 1963, Dr. Pourhassan immigrated to the United States in 1977 and became a U.S. citizen in 1991. He received his Bachelor of Science from Utah State University in 1985, his Masters of Science from Brigham Young University in 1990 and his Ph.D. in Mechanical Engineering from the University of Utah in 1998. Prior to joining the Company from 2006 to 2008, Dr. Pourhassan was an instructor of Mechanical Engineering at The Center for Advanced Learning in Oregon, and from 2005 to 2006 was an instructor at Mount Hood Community College. Over the past twenty years, Dr. Pourhassan has also managed a family-owned export/import and manufacturing business.

Denis R. Burger, Ph.D Vice Chairman & Scientific Officer: Dr. Burger was appointed a Director in February 2014, named Vice Chairman in August 2014 and Chief Science Officer in January 2016.  He is a life sciences executive with over 30 years of extensive scientific, operational and financial experience in the biotech industry.  As CEO or chairman of several biotechnology companies, Dr. Burger has led numerous corporate financing transactions and public securities offerings and has experience leading R&D, GMP manufacturing and clinical development functional areas.  Dr. Burger is currently a Director of Aptose Biosciences Inc., a cancer therapeutics, NASDAQ-listed company. Dr. Burger co-founded Trinity Biotech, a NASDAQ-listed diagnostic company, in June 1992, served as its Chairman from June 1992 to May 1995, and is currently lead independent director.  Until March 2007, he was Chairman and Chief Executive Officer of AVI Biopharma Inc. (now Sarepta Therapeutics), a NASDAQ listed RNA therapeutics company.  He was also a co-founder of Epitope Inc. (now Orasure Technologies, NASDAQ listed), serving as its Chairman from 1981 to 1990.  Dr. Burger previously held a professorship in the Department of Microbiology and Immunology and Surgery (Surgical Oncology) at the Oregon Health and Sciences University in Portland.  Dr. Burger received his undergraduate degree in Bacteriology and Immunology from the University of California in Berkeley and his Master of Science and Ph.D. degrees in Microbiology and Immunology from the University of Arizona.

Michael D. Mulholland Chief Financial Officer, Treasurer, and Corporate Secretary: Mr. Mulholland brings to CytoDyn more than 25 years of senior level financial leadership for public companies in the business services, retail and manufacturing industries. His broad experience includes strategic planning, corporate finance, including raising debt and equity capital, acquisitions, corporate restructurings, SEC reporting, risk management, investor relations and corporate governance matters. In addition to his financial management experience, Mr. Mulholland has also managed IP-asset development for the chemical inventions of a leading European scientific inventor for improving human health, working with IP counsel to evaluate and prosecute domestic and foreign patent applications. Most recently, from 2011-2012, he served as Chief Financial Officer of Nautilus, Inc., a NYSE-listed developer and marketer of fitness equipment. He previously was Co-Chief Financial Officer of Corporate Management Advisors, Inc., a private holding company of various businesses and investments, including a majority interest in a publicly held manufacturing company, from 2010 to 2011; Vice President of Finance of Gevity HR, Inc., a former Nasdaq-listed professional employer organization, from 2008 to 2009; Chief Financial Officer and Secretary of Barrett Business Services, Inc., a Nasdaq-listed business services firm, from 1994 to 2008; and Executive Vice President, Chief Financial Officer and Secretary of Sprouse-Reitz Stores Inc., a former publicly held retail company, from 1988 to 1994. He began his career with Deloitte & Touche LLP. Mr. Mulholland received a B.S. in accounting and a M.B.A. in finance from the University of Oregon. He is a certified public accountant.

Nitya, G. Ray, Ph.D : Nitya G. Ray, Ph.D. joined CytoDyn in November, 2015 and is responsible for Process Development, Manufacturing, Supply Chain and Quality. Dr. Ray is an accomplished leader with 30 years of progressive, hands-on experience in diverse manufacturing platforms and product development, including biologics, antibody drug conjugates, engineered tissue therapeutics, small molecule and radiopharmaceutical drugs. Prior to joining CytoDyn, Dr. Ray served as Senior Vice President of Manufacturing at Progenics Pharmaceuticals, Inc. where he was responsible for Process Sciences, Manufacturing and Quality control. Prior to that, he served as Director of Bioprocess Development at Ortec International and held positions of increasing responsibility at Hoffmann-La Roche in the areas of GMP manufacturing and process development for engineered tissue therapeutics and biopharmaceuticals, and at Verax Corporation where he developed process technology for biopharmaceutical manufacturing. Dr. Ray received a Ph.D. and M.S. in Chemical & Biochemical Engineering from Rutgers University and a B.S. in Chemical Engineering from Jadavpur University, India.

Potential Upcoming Catalysts: 

The company doesn't have much in terms of catalysts this year other than the phase 2b monotherapy results which were read out On 6/20/16 at the ASM Microbiome Conference. Both of the phase 3 trials in HIV are expected to be finished sometime in 2017. This means the company will file rolling BLA submissions to the FDA for potential approval. There will also be some results to be displayed at that time. Other than that there is possibly one for 2016: 

1. The trial with Pro 140 in GvHD starting sometime in 2016

Cash On Hand:

As with any biotechnology company it is important to note the cash on hand the company has in order to gauge how much money it has left. There are times where these companies can seek dilution, private placement money, partnerships with upfront payments, and other means. 

As of the most recent June 2016 investors presentation, the slides make mention that the company currently has adequate financing to run its business. This is because in January of 2016 the company raised $20 million from a private placement deal. 

Risks:

There is a lot of risk involved investing in such pharmaceutical companies. Even though Cytodyn has obtained positive preliminary results there is no guarantee that any of the drugs will reach the FDA, let alone for approval. Investors should be aware the risk of loss in investment in such companies and should contact a financial adviser if needed. Everything mentioned here is what the company has put out to date, therefore investors should do full due diligence and only invest in what they can afford to lose. The company trades on the OTC which makes it less liquid than other stocks, therefore there is more risk involved. 

Conclusion:

Cytodyn is a biotechnology company focused on changing the landscape for the HIV market. The fact that patients will only need to take a once a week injection over having to take pills everyday for the rest of their lives is impressive enough. Add on to the fact that HIV patients won't have to go through toxic side effects such as nausea, vomiting, liver damage, etc. to achieve viral suppression using Pro 140 is a game changer in the HIV space. Cytodyn is looking to improve these patients' lives, and if Pro 140 if successful it will do just that. Cytodyn isn't a one trick pony though, Pro 140 can also be modified to target other diseases such as cancer. Thus the reason why the company is doing a phase 2 in GvHD.  The potential for this company with a market cap of only $185 million is enormous. 

Disclosure: The Author of this report is Long Cytodyn (OTC:CYDY). The author has not received any compensation, nor intends to receive such compensation for the production for such a report. The author also has no business relationship with any of the companies mentioned in this report. 

The point of views, opinions, and recommendations represent those of the author. By viewing this material and acting upon any such investment decision based on this report you agree to release Helios Biotech Research and its owner operators for all liability in damages including any monetary loss and loss of principle investment. Those who choose to act upon an investment based off of this report will be fully responsible for all losses of capital.

None of this information is to be construed as financial or investment advice. This is no offer to recommend the buying or selling of a security. Everything written in this report is believed to be accurate at the time of publication. Every investor who reads this should do their own due diligence and determine if it is prudent and wise to make an investment. It is encouraged to contact a financial adviser before deciding to invest upon any security and determine if it meets your circumstances. 

This report has been developed as a free research report for all investors. 2016

Rxi Pharmaceuticals (RXII) Research Report

Rxi Pharmaceuticals (RXII) Research Report 2016

Company Name: Rxi Pharmaceuticals

Company Ticker: RXII

Float: 6 mil shares outstanding as of 5/28/16

Market Cap: $14 million 

Current Share price: $2.17

Most Recent Company Presentation For All Programs: May 3, 2016:

Bionetwork Partnering Summit

Most Recent Company Presentation for Cosmecueitcals program and RXI-109: 

IBC's 18th Annual Oligonucleotide and Peptide Therapeutics Conference: May 12, 2016

Summary: Rxi Pharmaceuticals is a dermatology and ophthalmology biotechnology company that uses RNAi science for unmet medical needs. The company has its main focus in hypertrophic scarring, and has since branched out to scarring due to wet-age related macular degeneration. Other programs include two candidates for cosmeceutical products, and samcyprone for: Warts, melanoma, and alopecia aerata. 

Technology: Rxi Pharmaceuticals uses a science known as RNAi or RNA interference which was discovered by Andrew Fire and Dr. Craig Mello. Interesting fact is that Dr. Craig Mello is on the scientific advisory board of Rxi Pharmaceuticals. Rxi uses a mixture of RNAi together with another oligonucleotide technology known as RNA. The combined molecule becomes the company's technology known as sd-rxRNA. What makes this technology so great is that it is a drug molecule that requires no delivery vehicle to penetrate target cells for particular diseases. This is important because RNAi science in the past has failed because there were not appropriate delivery vehicles. Rxi has solved this by just creating a hybrid RNAi + RNA molecule that could solve the delivery issue.

Pipeline Candidates:

Hypertrophic scarring: Hypertrophic scars are scars that are raised with excessive amounts of collagen. Wounds typically heal up normally, but there are times where too much collagen is rushed to the site of injury which sometimes gets out of control. Why is itimportant for Rxi as a biotechnology company to target hypertrophic scars? That's because there are "zero" I repeat zero drugs approved by the FDA to treat scars. This is a huge unmet medical need, one which Rxi has a chance to approach, and if it ultimately receives approval it will create history. The company also initiated keloid studies but because of money issues it put it off for now. The good news is that once a partner is established or new funds come in the company can probably reboot the keloid scar program. There is currently a phase 2a trial in both cohorts 1 and 2 , along with cohorts 3 and 4 ongoing. 

As of 2015, a research report shows that Global scar treatment market is estimated to be at $16 billion, and it is estimated that it will rise to $31.9 billion by 2022 

http://www.businesswire.com/news/home/20150918005204/en/Global-Scar-Treatment-Market-Stand-31.9-Billion

Keloid scarring: Keloid scars are like hypertrophic scars, except they grow out from their original wound site. They grow smooth and rough, and far more excessively than hypertrophic scars. As noted above in the link scarring is a huge market and it is a big unmet medical need as there are no approved therapies. Keloid trial has been put on hold for now until further funding is received.

Retinal Scarring Macular Degeneration: With the success of the preliminary phase 2a scar results, the company embarked on retinal scarring for eye indications. The first of which is a phase 1/2 trial in treating patients with age-related macular degeneration. Patients will be treated with RXI-109 to determine if it can reduce scars in patients with Wet-AMD. The phase 1/2 trial will assess safety and Best corrected visual acuity -- BCVA -- improved eyesight. Rxi lists market potential of this drug candidate with greater than $1 billion in the U.S. alone, and a potential of $5 billion globally. Current treatment options include: Lucentis, Avastin, or Eylea. The problem is that those drugs cover the anti-VEGF portion of macular degeneration, but don't do anything for the sub-retinal scarring that occurs thereafter. This means that the company has another candidate that has no FDA approved therapies for, and another unmet medical need. This is great again as there is no competition for this.

Corneal Scarring: The company is taking it one step further in eye scarring. It is targeting corneal scarring which is another huge unmet medical need. Current treatment options include eye surgery, and laser surgery. Those treatment options are painful, and can be quite risky. With Rxi's approach of using a topical gel it can be easier to treat. Think of only having to apply a gel to the eye, and then take effect of the scar/wound. Thus far in pre-clinical research the company has been able to successfully delivery eye drops or gel throughout the entire cornea. There are around 30,000 to 40,000 corneal transplants performed each year, which means another lucrative market for the company.

Cosmecueitcals: The company has chosen to branch off into the cosmecueitcal market. Using its RNAi technology it is developing products for consumer health. This is good because it will be able to take these products to market at a quicker rate compared to the therapeutics pipeline. That's because there is no need for FDA approval of cosmetic products. In addition, there are fewer steps to take to bring such products to market. The company has developed two different product candidates for such development.

1. RXI-231: this is an sd-rxRNA that targets Tyrosinase. With this compound the company can fix uneven skin, and skin pigmentation. 
2. RXI-185: this is also and sd-rxRNA but it targets collagenase. With this compound the company can go after skin wrinkles

This program is especially important because of the fact that it targets a large market. The market potential of both products can reach up to $200 billion. It is a large market but think of it this way even if the company only achieves 10% of the total market that would still be a $20 billion market opportunity. In addition, to the two products mentioned above being turned into cosmetic products, they are flexible because they can also be used to target other therapeutic diseases as well. Such therapeutic candidates could potentially be: melanoma, lung cancer, Neuroblastoma etc.

Partnerships:

Thus far, Rxi has engaged in small partnerships that have long-term value in mind. The two partnerships that Rxi has gotten into are the MirImmune Partnership and Thera Neuropharma. Rxi's sd-rxRNA transfects cells easily and these small cap players are licensing Rxi's tech in order to achieve this objective. These deals are small, but they offer Rxi some future milestone payments for using sd-rxRNA, along with 10% ownership of these companies with non-dilutive effect. 

1. MirImmune Partnershisp: With the MirImmune partnership Rxi has been able to enter the arena of cancer immunotherapy. MirImmune is still in the early stages but the pre-clinical results have been pretty good. 

From the February 6, 2016 conference on slide # 27 below in the link Rxi posted some preliminary data of MirImmune using Rxi's sdRNA platform together with anti-PD1 therapy: 

18th Bio CEO Conference

1. Thera Neuropharma Partnershp: Just recently on May 3, 2016 Rxi entered into a partnership with Thera Neuropharma to develop a product candidate for ALS or Lou Gherig's disease. This is another clear unmet medical need in the medicine field and another good opportunity for Rxi:

Rxi Pharma and Thera Neuropharma Partnership news release 

This is all good for Rxi, but despite advanced in clinical research with positive phase 2 results, and many good partnership deals the stock has tanked. One part of the reason is that Tang Capital converted preferred shares in the year prior dragging down the share price. The other part of the reason is lack of market acknowledgement. That is why I believe this company trading only with a $14 mil market cap is extremely attractive. So much so that even the company itself has decided to build shareholder value. 

A recent Press Release released by the company states that it had engaged Griffin Securities to either assist in a possible merger with another pharmaceutical company, or a potential partnership deal: 

Rxi Pharmaceuticals Press Release on Strategic Update

Management: 

President and CEO: Geert Cauwenbergh, Dr. Med. sc: Dr. Cauwenbergh was appointed President and Chief Executive Officer of RXi Pharmaceuticals Corporation in April of 2012. Prior to joining RXi, Dr. Cauwenbergh served as Chairman and Chief Executive Officer of Barrier Therapeutics, Inc., a publicly-traded biopharmaceutical company he founded in 2001 that focused on dermatology drug development. Barrier was acquired by Stiefel Laboratories, Inc. in 2008. Prior to founding Barrier, Dr. Cauwenbergh held a number of ascending senior management positions at Johnson & Johnson, where he was employed for 23 years. As Vice President, Research and Development for Johnson & Johnson’s Skin Research Center, he was responsible for the worldwide research and development of all skin care products for the Johnson & Johnson consumer companies. He is a member of the board of directors of Phosphagenics and Moberg Pharmaceuticals. In 2005, Dr. Cauwenbergh was inducted into the New Jersey High-Tech Hall of Fame, and, from 2009 to 2010, he served as Chairman of the Board of Trustees of BioNJ. He has authored more than 100 publications and has been a guest editor for a number of books in mycology and infectious diseases. Dr. Cauwenbergh received his Doctorate in Medical Sciences from the Catholic University of Leuven, Faculty of Medicine (Belgium), where he also completed his masters and undergraduate work.

Chief Development Officer: Pamela Pavco: Dr. Pavco currently serves as Chief Development Officer for RXi Pharmaceuticals, Corporation. She joined Galena Biopharma, Inc. in March of 2007 and most recently served as the Senior Vice President of Pharmaceutical Development until April 2012. Dr. Pavco has over 20 years of research and development experience in oligonucleotides. Dr. Pavco was Senior Director, Research and Development Project Management at Sirna Therapeutics, Inc., from 2002 until 2006, when it was acquired by Merck & Co., Inc. for $1.1 billion. While at Sirna, she was responsible for the discovery research and development of Sirna-027, the first chemically modified siRNA to enter clinical trials. Dr. Pavco also managed Sirna’s alliance with Allergan, Inc. that was initiated to continue discovery research in the area of ophthalmology and take Sirna-027 forward into Phase 2 clinical studies. While at Sirna, Dr. Pavco served in various additional capacities, including Director of Biology Research and Director of Pharmacology and she also managed numerous corporate collaborations and internal programs focusing on the development of therapeutic oligonucleotides in the fields of oncology, anti- angiogenesis, hepatitis, respiratory disease and Huntington’s disease. Dr. Pavco has authored numerous scientific articles and contributed to approximately 58 patents and patent applications in the oligonucleotide therapeutics field. Dr. Pavco received a Ph.D. in Biochemistry from Virginia Commonwealth University in 1983 and did her post-doctoral work at Duke University. She is a member of the American Association of Cancer Research and the Association for Research and Vision in Ophthalmology.

Vice President Medical Affairs & Safety Assessment: Lyn Libertine, M.D : Dr. Libertine currently serves as Vice President Medical Affairs & Safety Assessment for RXi Pharmaceuticals, Corporation. She joined Galena Biopharma, Inc. in August of 2007 and served as the Director of Pharmacology until April 2012. Prior to Galena, Dr. Libertine spent 5 years at Critical Therapeutics, Inc., which was acquired by Cornerstone Therapeutics Inc., where she was an integral member of the development team responsible for filing the sNDA for Zyflo, an oral medication for the treatment of asthma. Her asthma research resulted in the re-branding of Zyflo as a treatment specifically aimed to patients suffering from severe asthma. Prior to joining Critical Therapeutics, she held various research positions in pharmacology and toxicology at CytoMed, Inc., which was acquired by UCB Pharma in 2000. As part of the research team at UCB Pharma, Dr. Libertine managed a team focused on dystrophia myotonica protein kinase (DMPK) for pre-clinical candidate selection and was project leader for neurological and pain programs. Dr. Libertine did her undergraduate work in Chemistry and Biology at Boston University and received her medical degree at the University of Massachusetts. Throughout her career in research she has managed pharmacology and multi-disciplinary groups and used her medical background to oversee clinical projects through all stages of clinical development through marketing and life-cycle management. Dr. Libertine is a member of the American Medical Association, Massachusetts Medical Society, American Chemical Society, American Thoracic Society and the Association for Research and Vision in Ophthalmology.

Vice President Research: Karen Bulock, Ph.D. : Dr. Bulock currently serves as Vice President Research for RXi Pharmaceuticals, Corporation. She joined Galena Biopharma, Inc. in October of 2007 and served as the Associate Director of Research until April 2012. Dr. Bulock has over twenty years of experience in assay development and discovery project management. Since joining RXi in 2011, and previously while at Galena, Dr. Bulock has managed several key programs, including the discovery and preclinical development of RXI-109, RXi’s first clinical candidate. Prior to joining RXi, Dr. Bulock spent several years leading assay development and screening projects to support small molecule drug discovery programs in the fields of metabolic disease and anti-infectives at CytRx Corporation and Essential Therapeutics, Inc. Dr. Bulock received a Ph.D. in Pharmacology from Yale University. Dr. Bulock has authored numerous scientific articles and is a co-inventor on four patent applications.

The management team is strong and capable of leading charge for these drug candidates as they have years of experience. Each member of management have their own strengths and for that I see a good future for Rxi Pharmaceuticals. It important to also note that one member of the Scientific advisory board, Dr. Craig C. Mello was one of the co-founders of RNAi science. The fact that he is on the scientific advisory board for Rxi is remarkable in itself. All other RNAi companies owe thanks to Dr. Craig Mello and Andrew Fire for discovering RNAi. 

Potential Upcoming Catalysts:

1. Additional Phase 2 data for RXI-109-1402 in hypertrophic scarring is expected to be released by the 2nd half of 2016
2. Preliminary safety and Efficacy data is expected to be released 2nd half 2016 for RXI-109-1501 for retinal scarring of Macular degeneration. Investors will get a small early look at safety and possible efficacy effect of improved vision using Best corrected visual acuity -- BCVA
3. Preliminary phase 2 results read out for Samcyprone in Warts 2nd half 2016
4. Possible merger or collaboration with another biotechnology company -- Possible to happen in 2016 as noted in merger PR mentioned above

Market Cap: The company is sitting with a tiny market cap of $14 million only. Most other biotechnology companies in the same phase 2 stage of clinical trials trade typically between $300 million to $500 million market cap. Therefore there is a potential here for a large increase in returns pending positive clinical catalysts. 

Float: The company just recently enacted a 1 for 10 reverse stock split after the problems it had with Tang capital converting preferred shares into common shares and them dumping them. The good news is that now the company has a small float of only 6 mil shares outstanding and any single catalyst event will move the stock in a wild way. The good news is that there no longer preferred shareholders in place to put upward momentum to the stock. 

Cash On Hand: 

As with any biotechnology company it is important to note the cash on hand the company has in order to gauge how much money it has left. There are times where these companies can seek dilution, private placement money, partnerships with upfront payments, and other means. 

As of the 10-Q SEC Filing on 5/12/2016 Rxi Pharmaceuticals has cash and cash equivalents of $7.7 million as of March 31, 2016. The company believes this cash is enough to last the company at least 12 months. That means that the company should have enough capital until March of 2017 to fund clinical trials. 

As mentioned above the company is now using its technology to seek partners who will either want to merge together to pool resources, or to find a partnership with upfront money. This stems from the press release about the company looking into strategic options. There is no guarantee though that such a transaction will take place. If this happens then the company may have to seek dilution options. 

Risks: 

There is a lot of risk involved investing in such pharmaceutical companies. Even though Rxi has obtained positive preliminary results there is no guarantee that any of the drugs will reach the FDA, let alone for approval. Investors should be aware the risk of loss in investment in such companies and should contact a financial adviser if needed. Everything mentioned here is what the company has put out to date, therefore investors should do full due diligence and only invest in what they can afford to lose. 

Conclusion:

Rxi Pharmaceuticals is a biotechnology company focused on unmet medical needs. The company is in good shape because it is targeting diseases that have limited to no competition. As noted above there are no FDA approved products for skin scarring. In addition there are no FDA approved drug products for the scarring of patients with wet-age related macular degeneration. Rxi succeeding in late-stage clinical trials along approval, would mark it the first biotechnology company to receive FDA approval for skin scarring. Therefore the risk/reward has huge potential. There are two phase 2 clinical trials, and one phase 1 clinical trial. Along with many other pre-clinical candidates. The company's unique tech of the sd-rxRNA technology platform along with patent protection affords the potential to outlicense/inlicense its technology to any other biotech it wants to. The fact that it trades at $14 million while many of its peers trade with a market cap of $300 million to $400 million makes it a very compelling investment. 

Disclosure: The Author of this report is Long Rxi Pharmaceuticals (RXII). The author has not received any compensation, nor intends to receive such compensation for the production for such a report. The author also has no business relationship with any of the companies mentioned in this report. 

The point of views, opinions, and recommendations represent those of the author. By viewing this material and acting upon any such investment decision based on this report you agree to release Helios Biotech Research and its owner operators for all liability in damages including any monetary loss and loss of principle investment. Those who choose to act upon an investment based off of this report will be fully responsible for all losses of capital.

None of this information is to be construed as financial or investment advice. This is no offer to recommend the buying or selling of a security. Everything written in this report is believed to be accurate at the time of publication. Every investor who reads this should do their own due diligence and determine if it is prudent and wise to make an investment. It is encouraged to contact a financial adviser before deciding to invest upon any security and determine if it meets your circumstances. 

This report has been developed as a free research report for all investors. 2016

Introduction To Helios Biotech Research

Helios Biotech Research

Hello all, welcome to Helios Biotech Research. It is my mission with this website post research reports on biotechnology companies that show a lot of promise. I will dive into the company's pipeline, management, cash on hand, and other important aspects of the company that investors should know. This is research based off the many years of knowledge I have gained in the biotechnology industry. These companies that I choose will be ones in which I believe have real value, and may or may not be ignored by the market. It is my mission to give good reports so that investors may be able to find a good speculative play for their portfolio. Understand that everything I post is my opinion, and investors should choose to act up any investment under their own risk. This is merely a platform where investors can read some due diligence on biotech stocks and decide if the risk is worth it for them to invest in the company. The first research report will be on its way real soon, and it will be on a company that I believe has a good future. The first biotech my research report will cover is Rxi Pharmaceuticals (NASDAQ:RXII). I will be posting everything about it so that investors may decide whether or not it is a worthy investment for them. It is important to note that some stocks I post I may or may not have a position in. I will be sure to mark at the end of any research report whether or not I currently own a position in the stock I am writing about. Thank you all and I hope that you find this website fun and informative.