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News Article | May 8, 2017
Site: www.chromatographytechniques.com

Kidney research at the University of Virginia School of Medicine has unexpectedly led to a discovery about the formation of the heart, including the identification of a gene responsible for a deadly cardiac condition. UVA scientists were surprised to discover that the heart's inner lining forms from the same stem cells, known as "precursor cells," that turn into blood. That means a single type of stem cell turns into both our blood and a portion of the organ that will pump it. The researchers determined that a particular gene, S1P1, is vital for the proper formation of the heart. Without it, the heart tissue produced by the precursor cells develops a sponginess that compromises the heart's ability to contract tightly and pump blood efficiently. In people, that is known as ventricular non-compaction cardiomyopathy, a dangerous condition that often leads to early death. "Many patients who suffer from untreatable chronic diseases, including heart and kidney diseases, are in waiting lists for limited organ transplantation. Therefore, there is an urgent need to understand what happens to the cells during disease and how can they be repaired," said researcher Yan Hu, PhD. "Every organ is a complex machine built by many different cell types. Knowing the origin of each cell and which genes control their normal function are the foundations for scientists to decipher the disease process and eventually to find out how to guide the cells to self-repair or even to build up a brand new organ using amended cells from the patients." The researchers, led by Maria Luisa S. Sequeira-Lopez, MD, of UVA's Child Health Research Center, were investigating how the kidney forms when they noted that the deletion of the S1P1 gene in research mice had deadly consequences elsewhere in the body . "We were studying the role of these genes in the development of the vasculature of the kidney," she recalled. "The heart is the first organ that develops, and so when we deleted this gene in these precursor cells, we found that it resulted in abnormalities of the heart, severe edema, hemorrhage and low heart rate." That led them to look more closely at the heart. It was then that they discovered the gene deletion had caused thin heart walls and other cardiac problems in developing mice embryos. "So then we had to study the heart when the kidneys were still not even formed," she said. "We had to go far outside our comfort zone." Their findings would prove unexpected even for scientists who specialize in the development of the heart. "For a long time, scientists believed that each organ developed independently of other organs, and the heart developed from certain stem cells and blood developed from blood stem cells," explained researcher Brian C. Belyea, MD, of the UVA Children's Hospital. "A number of studies done in this lab and others, including this work, shows that there's much more plasticity in these precursor cells. What we found is that cardiac precursor cells that are present in the embryonic heart do indeed give rise to components of the heart in adults but also give rise to the blood cells." The researchers were so surprised by their discovery that they went back and validated their findings repeatedly, using multiple techniques, including new techniques that they developed. Belyea said that the discovery about the important role of the S1P1 gene may one day lead to better treatments for that condition. "We hope," he said, "that this is a stepping stone for our clinical colleagues."


News Article | May 9, 2017
Site: www.prweb.com

Bruce Lerner, inventor of Flip’N Shades, recently released the company’s innovative 2017 Eclipse Shades in time for the Monday, August 21, total solar eclipse. “Anyone within the path of totality will be able to see one of nature’s most awe-inspiring sights - a total solar eclipse - and will need Eclipse Shades to view it safely,” said Lerner. On August 21, the moon’s umbral shadow will fly across the United States, from Oregon to South Carolina, in a little over 90 minutes. The path of this shadow, the path of totality, is where observers will see the moon completely cover the sun for approximately 2.5 minutes. Flip’N Shades 2017 Eclipse Shades, which come with a commemorative hat, are ISO rated and approved for viewing the eclipse. Furthermore, a portion of the proceeds from the glasses will go to the Bleeding Disorders Alliance Illinois(BDAI) for research. “My main goal with Flip’N Shades is to help fund continued research and assist BDAI in its mission to support those families coping with bleeding disorders,” said Lerner, who developed the concept for Flip’N Shades during his tenure as a member of the Board of Directors of BDAI and whose son suffers from hemophilia. BDAI provides its members with the unbiased medical information and resources that allow them to live a healthy and active lifestyle. Lerner has been donating a percentage of his profits from Flip’N Shades, which attach to the visor of any cap or hard hat, to BDAI for the past ten years. To purchase Flip’N Shades 2017 Eclipse Shades, please visit http://flipnshades.com/2017-Eclipse-Shades-EC2017.htm. With the purchase of the limited edition 2017 Eclipse Hat and Flip’N Shade, Flip’N Shades is offering a complimentary Smoked Flip’N Shade (Pay only a special $3.00 shipping rate). About Flip’N Shades Flip’N Shades conveniently attaches to the visor of any cap or hard hat. Their design allows them to work whether or not one wears prescription glasses. They are infinitely adjustable for a perfect fit every time. Flip’N Shades is designed and made in the USA. They are UVA/UVB rated, impact resistant and have an ANSI rating for commercial use. Flip’N Shades come in a variety of colors and have the option for custom printing on the lenses which allows any organization to get its message out or create an identity in a novel and fun way. For more information, call 800-394-7151 or visit http://www.flipnshades.com. About the NALA™ The NALA offers small and medium-sized businesses effective ways to reach customers through new media. As a single-agency source, the NALA helps businesses flourish in their local community. The NALA’s mission is to promote a business’ relevant and newsworthy events and achievements, both online and through traditional media. For media inquiries, please call 805.650.6121, ext. 361.


News Article | May 13, 2017
Site: news.yahoo.com

Mother’s Day is almost upon us and that means it’s time to show mom you care. While any mother would undoubtedly be thrilled just to spend time with her children, gifts are another nice way to show some extra love. For those looking to purchase their mother (or wife!) something special for the 2017 holiday, we’ve got your covered with some unique, last-minute gift ideas. A healthy mom is a happy mom! Care/of allows you to curate daily vitamin packages. After answering a few questions about goals, lifestyles and values, the retailer can help recommend which supplements will best be suited. From there, a personalized box of daily vitamin packs will be delivered each month. Subscriptions, which vary in price, can be canceled or adjusted at anytime and orders over $20 ship for free. Check out all available products here. Mom’s skin deserve the best. Why not pamper her with a luxury toner from Baszicare this Mother’s Day? The company’s Roseus Floral Hydrating Toner ($110) works with the help of a collection of botanical extracts and essential oils to moisturize the skin and rose hydrosol to sooth and revitalize. Don’t mind the name. Man Crates also has amazing gifts perfect for women! Help mom get ready for the summer ahead with the On The Water Pack ($129.99). This awesome gift includes a roll-top Kawartha dry bag complete with cooler insert, a micro towel, floating 100% UVA and UVB protective sunglasses, a clip on/suction waterproof and floatable Bluetooth speaker and a waterproof phone sleeve from Kikkerland. Please note this package does not come in a crate. Orders placed before noon PST will ship out the same day. Help mom look good even if the heat of the summer. While most makeup can’t withstand the power of the sun’s rays, BrowGal’s Highlighter Pencil ($20) does the trick, all the while giving a luxurious dewy glow around the brow bones, cheeks and lips. This dual ended pencil is easily bendable, can also be used as a concealer and its Vitamin K and Alfalfa Extracts helps reduce puffiness. Buying jewelry for mom is affordable with Serenity. The costume jewelry line’s Bubble Boo Bracelet ($155) is sure to thrill her. It’s made in 925 Sterling Silver and comes with white gold or Rose Gold plating, both with Swarovski Pearl. It’s hard to keep hair healthy, but not when you’re getting some expert help. Arya Essential’s Hair Oil makes hair strong and healthy and prevents again breakage with its combination of coconut-oil, Amla, Bhringaraj, Fenugreek extract. A 100 ml bottle retails for $68. If mom is the cook of the family, give her a helping hand in the kitchen by gifting her Gobble, the only one-pan, ready-to-cook meal service. Ingredients for healthy meals that take 15 minutes or less to make are delivered to your door so no food shopping is required. Gobble meals start at $13.95 per meal for 4 meals and $11.95 per meal for 6 or more meals. Tax and shipping are included.


News Article | May 10, 2017
Site: www.prnewswire.com

According to SkinCancer.org, one in five Americans will develop skin cancer in the course of a lifetime, and each year over 5.4 million cases of nonmelanoma skin cancer are treated in more than 3.3 million people in the U.S. While these numbers are startling, there is hope. Skin cancer can be drastically reduced by the use of window film. "Many people don't think about the sun damage that can be coming through their windows when sitting by a window at home, at work, or while driving," says Darrell Smith, Executive Director of the IWFA. "Professionally installed window film offers a high-tech and cost-effective way to help protect both skin and eyes." Sunlight streaming through your home, work and car windows can be beautiful, but it can also be dangerous. Deep-penetrating Ultraviolet A (UVA) rays from the sun pass through ordinary glass and account for 90 percent of the sun's most damaging rays. In fact, a recent study published by JAMA Ophthalmology found that the average side-window of a vehicle may only block about 70% of dangerous UV rays. By blocking up to 99 percent of UV rays from passing through your unprotected windows, professionally installed window film can help keep your skin and eyes healthier and more protected than window glass alone. "Limiting sun exposure is one of the most important measures in preventing skin cancer," says American Society for Dermatologic Surgery President Thomas E. Rohrer, MD. "Indirect UV rays can also cause skin damage. Window film provides protection by limiting harmful UV rays whether at home, work or on the road." To learn more about how to better protect yourself from the sun in your home, at work, or while driving, be sure to read the IWFA's Beauty Inside & Out e-Booklet and Consumer Guide to Automotive Window Film e-Booklet. To find professionally accredited window film installers near you, visit the IWFA's ; for more information on NWFD, visit . About the International Window Film Association ) is a unified industry body of window film dealers, distributors, and manufacturers that facilitates the growth of the window film industry though the use of education, research, advocacy and consumer awareness.  The organization builds alliances with trade associations, utilities and government agencies to advance dealers' and distributors' businesses and provide value to their customers. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/skin-cancer-awareness-month-tips-from-the-international-window-film-association-300455021.html


News Article | May 11, 2017
Site: www.techtimes.com

The warmer months have arrived, and children and adults alike are ready to bask in the sun. But while the sun’s rays feel good, they can be your skin’s worst enemy, potentially causing wrinkles, age spots, and even skin cancer. Skin cancer rates are on the rise at more than 76,000 new invasive melanoma cases poised to be diagnosed in the United States last year. More than 90 percent of melanoma skin cancers are actually caused by sun exposure. How sun-safe and protected are you and your family? Here are some tips from the experts so you can safely play under the sun this season. Over time, according to WebMD, the sun’s UV light harms skin fibers called elastin, which prompts skin to sag and stretch as they break down. Too much time in the sun, too, can also lead to skin freckles, white spots, rough texture, and yellow of skin, to name a few issues. First on one’s sun-safe list should be wearing sunscreen every day, no matter what weather or season you are in. The sun protection factor or SPF should be 30 and declared “broad-spectrum” on the label, meaning it protects against both UVA and UVB rays. Slather the sunscreen on your skin at least 15 minutes before going outside, with 1 ounce (about the size of a shot glass) as the recommended amount. Reapply at least every 80 minutes, or more frequently as you sweat or swim. Even babies and young kids need sunscreen, so check out the findings from nonprofit organization Environmental Working Group on which sunscreen products are most child-friendly. Generally, the best-rated products contain zinc oxide and titanium dioxide for ultraviolet filters, which are deemed stable in sunlight and offer balanced protection from UVA and UVB rays. Taking a skin supplement will boost your protection, advised dermatologist Dr. Leslie Baumann. One key ingredient is Polypodium leucotomos, a fern extract shown to help shield the skin from UV damage and even reduce redness after sun exposure. Take the recommended dose in the morning, particularly if you know you will stay out in the sun for long periods of time. But don’t forget to wear that sunscreen, Baumann reminded. Sunglasses and wide-brimmed hats are not just fashionable, but also helpful in the fight against harmful sun exposure. While you’re at it, don long-sleeved shirts and pants as well. Cosmetics like makeup as well as contact lenses that advertise UV protection are near useless, as you still need to use sunscreen and wear those glasses with broad-spectrum protection. As for makeup proclaiming the letters “SPF” on the label, Baumann thinks you should forget it. "You would need to apply 14 times the amount [of powder] people normally use," she said, adding that the same goes for foundation and similar cosmetics for covering skin. Stay indoors from 10 a.m. to 2 p.m. as much as you can, as this is the time of the day when the sun is at its most merciless. Check your skin regularly to determine what’s normal, along with any new growth or change that emerges. Instead of using tanning beds, settle for tanning lotions, gels, and sprays that temporarily tint your skin (but not before you check the label and the ingredient list and composition). © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


News Article | May 8, 2017
Site: www.chromatographytechniques.com

Kidney research at the University of Virginia School of Medicine has unexpectedly led to a discovery about the formation of the heart, including the identification of a gene responsible for a deadly cardiac condition. UVA scientists were surprised to discover that the heart's inner lining forms from the same stem cells, known as "precursor cells," that turn into blood. That means a single type of stem cell turns into both our blood and a portion of the organ that will pump it. The researchers determined that a particular gene, S1P1, is vital for the proper formation of the heart. Without it, the heart tissue produced by the precursor cells develops a sponginess that compromises the heart's ability to contract tightly and pump blood efficiently. In people, that is known as ventricular non-compaction cardiomyopathy, a dangerous condition that often leads to early death. "Many patients who suffer from untreatable chronic diseases, including heart and kidney diseases, are in waiting lists for limited organ transplantation. Therefore, there is an urgent need to understand what happens to the cells during disease and how can they be repaired," said researcher Yan Hu, PhD. "Every organ is a complex machine built by many different cell types. Knowing the origin of each cell and which genes control their normal function are the foundations for scientists to decipher the disease process and eventually to find out how to guide the cells to self-repair or even to build up a brand new organ using amended cells from the patients." The researchers, led by Maria Luisa S. Sequeira-Lopez, MD, of UVA's Child Health Research Center, were investigating how the kidney forms when they noted that the deletion of the S1P1 gene in research mice had deadly consequences elsewhere in the body . "We were studying the role of these genes in the development of the vasculature of the kidney," she recalled. "The heart is the first organ that develops, and so when we deleted this gene in these precursor cells, we found that it resulted in abnormalities of the heart, severe edema, hemorrhage and low heart rate." That led them to look more closely at the heart. It was then that they discovered the gene deletion had caused thin heart walls and other cardiac problems in developing mice embryos. "So then we had to study the heart when the kidneys were still not even formed," she said. "We had to go far outside our comfort zone." Their findings would prove unexpected even for scientists who specialize in the development of the heart. "For a long time, scientists believed that each organ developed independently of other organs, and the heart developed from certain stem cells and blood developed from blood stem cells," explained researcher Brian C. Belyea, MD, of the UVA Children's Hospital. "A number of studies done in this lab and others, including this work, shows that there's much more plasticity in these precursor cells. What we found is that cardiac precursor cells that are present in the embryonic heart do indeed give rise to components of the heart in adults but also give rise to the blood cells." The researchers were so surprised by their discovery that they went back and validated their findings repeatedly, using multiple techniques, including new techniques that they developed. Belyea said that the discovery about the important role of the S1P1 gene may one day lead to better treatments for that condition. "We hope," he said, "that this is a stepping stone for our clinical colleagues."


SHANGHAI, May 11, 2017 /PRNewswire/ -- JinkoSolar Holding Co., Ltd. ("JinkoSolar" or the "Company") (NYSE: JKS), a global leader in the PV industry, today announced that its modules have received IEC61345 certification from TUV Rheinland. IEC61345 certification employs stricter testing criteria compared to IEC61215 certification, which currently serves as the industry standard UV test. It is mainly used to test modules' UV resistance under ultraviolet b ("UVB", 280nm~320nm), which requires exposure to exceed 7.5KWh/m2 on the top side and 0.75KWh/m2 on the reverse side. To meet these stringent standards, exposed modules on the top side should be over 137.8KWh/m2 under UVA+UVB (280nm~400nm). "I'm proud that JinkoSolar is the first Chinese PV manufacturer to receive IEC61345 certification, which further demonstrates our technology strength and leading position in the industry," commented Mr. Kangping Chen, Chief Executive Officer of JinkoSolar. "We have always been committed to providing our clients with the highest quality and most reliable products while being at the forefront of solar technology." About JinkoSolar Holding Co., Ltd. JinkoSolar (NYSE: JKS) is a global leader in the solar industry. JinkoSolar distributes its solar products and sells its solutions and services to a diversified international utility, commercial and residential customer base in China, the United States, Japan, Germany, the United Kingdom, Chile, South Africa, India, Mexico, Brazil, the United Arab Emirates, Italy, Spain, France, Belgium, and other countries and regions. JinkoSolar has built a vertically integrated solar product value chain, with an integrated annual capacity of 5.0GW for silicon ingots and wafers, 4.0GW for solar cells, and 6.5 GW for solar modules, as of December 31, 2016. JinkoSolar has over 15,000 employees across its 6 productions facilities in Jiangxi, Zhejiang and Xinjiang Provinces, China, Malaysia, Portugal and South Africa, and 15 overseas subsidiaries across Japan (2),  Singapore, India, Turkey, Germany, Italy, Switzerland, United States, Canada, Mexico, Brazil, Chile, Australia and South Africa. JinkoSolar has 18 global sales offices across China (2), United Kingdom, Bulgaria, Greece, Romania, United Arab Emirates, Jordan, Saudi Arabia, Kuwait, Egypt, Morocco, Ghana, Kenya, Costa Rica, Colombia, Brazil and Mexico. To find out more, please see: www.jinkosolar.com This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends, "plans," "believes," "estimates" and similar statements. Among other things, the quotations from management in this press release and the Company's operations and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in JinkoSolar's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. For investor and media inquiries, please contact: In the U.S.: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/jinkosolar-becomes-first-chinese-pv-manufacturer-to-receive-iec61345-certification-from-tuv-rheinland-300455843.html


I serve as the CEO of Sylva International, and my firm and I are shareholders of Soligenix. I recently had the opportunity to converse with Dr. Chris Schaber, CEO of Soligenix (NASDAQ: SNGX), regarding the current status and future of Soligenix. I came away from our conversation very excited for a number of reasons, which I will get to shortly. I also asked Dr. Schaber if Dr. Straube (CMO) and Dr. Donini (CSO) would be willing to respond to some questions I had regarding their clinical pipeline. Before getting to the Q&A with Drs. Straube and Donini, I wanted to highlight a subject that came up in my conversation with Dr. Schaber. The subject was the $25M mixed prospectus/shelf that was filed on May 5 th. It seems to me that many investors perceived this prospectus as the company seeking to raise capital immediately and, as such, the share price has been under pressure. For those of you who do not know me, I have been investing in and advising public companies for nearly 20 years. I am a Registered Investment Advisor in my home state of Oregon, as is my firm, Sylva International. In this day and age, any development stage small/microcap public company should have a shelf on file with the SEC, in my opinion, as it may provide the company with considerable optionality and negotiating leverage. Let's address negotiating leverage. Assume a company wishes to acquire Soligenix as a whole, rather than acquire one of the many assets Soligenix owns and is developing. Without an effective shelf registration in place, Soligenix will likely be valued based solely on the cash on their balance sheet (approximately $9M at year end 2016), plus the negotiated value of their assets under development. However, with a $25 million shelf in place, and personally I wish it was a $250 million shelf, Soligenix now has negotiating power and considerable optionality because their stock can be used as an asset to raise capital. When negotiating with a potential acquirer, the financing alternative is leverage that can be used to either strike a better deal for shareholders, or walk away from the transaction altogether. Given Soligenix's new found liquidity, the company could raise $25M tomorrow, should it choose, which means Sologenix will be able to negotiate from a position of strength. Soligenix did not have this optionality just two months ago. To those of you worried about any dilution at the current valuation, per my recent discussion with Dr. Schaber, CEO of Soligenix, there is no plan to raise money as it is not needed. Not to sound like a broken record (remember those?), Dr. Schaber stated to me that the company has zero intention of raising any money at the current valuation and that Soligenix raised money in December 2016 and, as such, has no pressing need for cash. With that stated, Dr. Schaber also understands what the significant increase in average dollar volume means to Soligenix and that is what has me smiling, as a shareholder! Two months ago, March 9th 2017, the company could not raise $25M money, given the average daily trading volume was a meager 101,355 shares a day over the past 30 calendar days from March 9th to February 9th. The average daily volume in that 30 calendar day period multiplied by the share price on March 9th equated to $236,157 of average daily dollar volume, given the closing price on March 9, 2017 of Soligenix was $2.33. Now, let's fast forward to May 9th, 2017 and the stock closed at $2.55 and average daily trading volume over the past 30 calendar days has been 1,609,836, which equates to , a MASSIVE difference. This increase in daily dollar trading volume over the past 30 calendar days is of major value for shareholders of Soligenix - allow me to explain why. Let's go back to my hypothetical acquirer looking to buy Soligenix, before the substantial increase of Soligenix average daily dollar trading volume; the hypothetical acquirer would calculate their acquisition price by utilizing a risk adjusted net present value calculation ("NPV"), which essentially takes the estimated value of a stream of future cash flows that result from sales of developed drugs, then discounts that value to a present day figure, and adds cash and cash equivalents that are currently on the company's balance sheet. With a shelf in place, however, a prospective acquirer or partner must take into consideration that Soligenix has the ability to raise $25M, literally overnight, given the increase in average daily dollar trading volume. As a result, the NPV calculation will be adjusted considerably, because the company has viable financing options. In turn, the optionality provides Sologenix with negotiating leverage, making the company A LOT more valuable. For fun, let's assume Soligenix gains FDA approval for SGX942 in Oral Mucositis and launches SGX942 by itself. Many experts have stated that the market for Oral Mucositis is $500M, or greater, annually worldwide. SGX942 has a number of potential benefits that may help those afflicted with Oral Mucositis and, as such, Soligenix may garner a majority, if not all, of the market share for this $500M+ market. So, given that assumption, what is Soligenix worth today? The answer has to be something in excess of the meager $13.95M market cap at which the company now trades. This massive increase in average daily dollar trading volume should be met with cheers versus jeers by shareholders. The reason why it should be cheers versus jeers is because the value of partnering or purchasing Soligenix just went up substantially because of the optionality and leverage Soligenix now has given this increase in average daily dollar volume. Many of you have called or emailed me asking me why the stock price is under pressure, why the company filed a $25M shelf, and what do I think? Well, now you know why I answer the phone downright giddy as it relates to Soligenix, as it sure looks like they are shining! As I mentioned earlier in this article, I conducted a Q&A with Dr. Richard Straube, MD, Chief Medical Officer, Soligenix and Dr. Oreola Donini, PhD, Chief Scientific Officer, Soligenix. As promised, our Q&A is below: 1. : When evaluating the compounds used to manage Oral Mucositis ("OM"), what options currently exist, what do they cost annually, and how do they improve or neutralize OM, if at all? : As you know, oral mucositis (OM) is an extremely debilitating side effect of many cancer treatments. Although there are ways to prevent OM, for some treatments, this may come with the risk of also protecting the tumor. Because the tumor treatment is the primary treatment objective, tumor protection is a major safety issue. There is no approved drug for the treatment of oral mucositis in head and neck cancer (or indeed any "solid" tumor - that is, a tumor affecting an organ rather than the blood). There is only one approved drug for treatment of any type of oral mucositis in hematological cancers. It is called palifermin and it is contraindicated in solid tumors. This is because the treatment (which is actually used prophylactically) is actually a tissue growth factor that could encourage solid tumors to grow. Other "treatments" for OM are not approved drugs, but rather 510k devices - this means that they did not have to show efficacy data to get approved by the FDA. The use of these approaches is considered palliative only and they do not treat the underlying disease. Thus, there are no true treatment options for OM in any solid tumor setting at the current time. Severe OM not only has major impacts on the patient's quality of life and their ability to tolerate a complete course of chemoradiation therapy, it also has a major financial impact. In 2007, it was estimated that head and neck cancer patients that developed severe OM required extra hospitalizations and care that total to about $17,000, and these costs are probably higher today. 2. : SGX942 is what Soligenix is developing to treat OM, and the compound is now in a Phase 3 trial. Can you tell us how SGX942 may improve or neutralize OM? : Over years of study, we have come to understand that OM is driven by a dysregulated inflammatory response of the innate immune system. The innate immune system responds to the damage caused by the chemoradiation therapy by triggering an inflammatory signaling cascade, which makes the damage done by the initial chemoradiation even worse. SGX942 is an Innate Defense Regulator. It modulates the innate immune system, enhancing the tissue healing and anti-infective pathways while modulating the inflammatory pathways. Thus, SGX942 deals with the downstream consequences of triggering the innate immune system and thereby prevents the damage from getting worse. Importantly though, it doesn't protect the initial damage to the mucosa that is directly caused by the radiation and chemotherapy, because this would also protect the tumor. The drug is specifically targeted to reduce the amplification of the musical damage caused by the over-exuberant inflammation triggered by this initial insult. It's other actions, bacterial destruction and enhanced tissue healing decrease the duration of the damage that does occur. In the Phase 2 study, we saw a 50% decrease in the duration of severe OM. Severe OM means that the damage to the oral mucosa is so severe the patient has visible ulcers in their mouth and cannot eat and/or drink. We also identified a high risk patient population in the Phase 2 trial, those receiving the highest doses of concomitant chemotherapy, who had a median duration of 30 days of severe OM in the Placebo group - and in this subgroup, treatment with SGX942 (1.5 mg/kg) reduced the duration by 67% (to 10 days). Actually, the Innate Defense Regulators may have some anti-tumor action, as well, but this is not the primary aim of our treatment. Rather, we take this as an encouraging sign that SGX942 will not negatively impact tumor control. In fact, in our Phase 2 study, we saw indications that the SGX942 treatment group (1.5 mg/kg) had a higher rate of complete tumor resolution at the 1-month follow-up visit than the placebo group. We also saw a reduced rate of infection, particularly bacterial (or "non-fungal") infection, also consistent with the mechanism of action. Finally, in the long-term (12 month) follow-up results, which we announced in on December 8, 2016, we also saw a reduced mortality rate in the 1.5 mg/kg SGX942 treated group. I would encourage those reading this interview today to go back and check out the press release. 3. : Is there a possibility SGX942 may eliminate OM? : As I noted above, the initial damage to the mouth is done by the chemoradiation therapy that is targeting the tumor, but also causes damage to rapidly dividing cells, such as those found in the mucosa of the mouth. Clearly, this initial damage cannot be "undone" without also protecting the tumor. However, the more severe OM, which is also driven by the innate immune system, certainly can be "undone," and this is the aim of SGX942 treatment. 4. : Switching gears a bit, you have another Phase 3 clinical candidate meant to treat CTCL named SGX301. Can you tell us how SGX301 works and, if approved, what sort of impact the compound may have? : SGX301 is a combination product - a topically applied ointment (synthetic hypericin) which is activated by safe, cost-effective fluorescent light. The ointment is applied to the cutaneous T-cell lymphoma lesions (CTCL) for up to 24 hours to allow it to be taken up by the cancerous T-cells in the skin. The following day, the lesion is exposed to fluorescent light for a short period of time (e.g., about 5-10 minutes). The light activates the synthetic hypericin, causing it to release free radicals which induce apoptosis (programmed cell death of the lesion cells only). This is called photodynamic therapy. There is no approved first line treatment for CTCL. There are other photodynamic therapies, which are used off-label, in CTCL - such as PUVA. The distinction here is that this photoactivating agent known as Psoralen is mutagenic and the UVA light used to activate it is carcinogenic; as a result, the product has a BLACK BOX warning for causing other (potentially more fatal) skin cancers, such as melanoma. SGX301 is neither carcinogenic nor mutagenic and is, therefore, potentially much safer to use. This is particularly important because CTCL can be a very slowly progressing disease when appropriately treated, with the need for multiple treatments over years and decades. We expect SGX301 to have a significant impact, if approved, since it will be a very safe therapy for a disease which currently has no available front-line therapy and all secondary therapies come with significant safety concerns. 5. : Soligenix has a robust vaccine program under development that has received nearly $60M in government funding. The Vaccines/BioDefense segment is involved in the development of RiVax, a ricin toxin vaccine candidate, which has completed Phase IB clinical trial for the treatment of vaccine against ricin toxin poisoning; OrbeShield, a GI acute radiation syndrome (GI ARS) therapeutic candidate, which is in pre-clinical stage to treat therapeutics against GI ARS; and SGX943, a melioidosis therapeutic candidate that is in pre-clinical stage for the treatment of melioidosis. Its vaccines are supported by its ThermoVax, a heat stabilization technology. Can you tell us how this heat stabilization technology works? : Heat stabilization works by "freezing" the protein in a glass-like state with minimal water. This is important because of a lot of protein degradation reactions occur due to water. By minimizing the water, and providing a stable solid state, the protein is protected and remains in its active conformation. While this has long been understood, the presence of aluminum, a common adjuvant in vaccines, causes significant problems with this process. With our proprietary technology, we can even stabilize aluminum-adjuvanted vaccines, and believe there may be even broader applications. The initial use of this technology has been applied to our RiVax® vaccine that, although very effective, was extremely unstable in classic formulations and lost substantial activity over several weeks even in refrigerated conditions. When the vaccine was stabilized using this process, the vaccine was 100% potent after being stored for more than a year at 104°F. 6. : In your most recent press release, you focused on correlates of immune protection. Can you explain what these are and why these are important, particularly in the context of the Animal Rule? : As you know, our most advanced thermostabilized vaccine is RiVax®, a vaccine to protect individuals from exposure to ricin. We have tested the antigen (without the thermostablized formulation) in healthy human volunteers and shown it to be safe. We have tested the fully thermostabilized vaccine in animals and shown it to be 100% protective to subsequent ricin exposure, even when the exposure is by aerosol, the most lethal route of exposure. The FDA "Animal Rule" is a way of getting a drug approved for the treatment of diseases or exposures that one cannot ethically generate efficacy data in humans. For example, the RiVax vaccine is designed protect people exposed to ricin, most likely as the result of terrorist or military use of the extremely deadly poison, from dying from the poison. Obviously, it is unethical to conduct a typical clinical trial in which some subjects get the drug and a separate group gets an inactive placebo and then exposed both group to ricin exposure and see how many die in each group. Because the need to prove efficacy in situations in which human trials are ethically impossible but critically needed to protect high-risk groups of people, a common situation with biodefense products, the FDA established a route for Marketing Approval usually referred to as the Animal Rule. Under the Animal Rule you need to demonstrate the following key things: 1. That your treatment is safe in humans; 2. That your treatment is effective in animals; and 3. That you can predict efficacy and dosing in humans based on your animal studies. This means that the disease in animals must mimic the disease in humans and that the response of the animals to your treatment is the same as would be expected in humans and that there is some metric you can use to assess the needed dose in humans. In terms of ricin intoxication - the animal models are very reproducible of the human disease (the toxin kills all cells the same way). We have already demonstrated in a pilot study that non-human primates respond to our vaccine in a similar manner as humans. The last step was to predict the appropriate dose levels to use in humans. In the vaccine world, this means being able to determine a level of immunogenicity in animals that correlates to survival in animals and then show that humans (say in a Phase 1 trial) can achieve the same level of immunogenicity. This last step is the one we have begun to make progress on. With our colleagues at HRI/NYSDOH in the laboratory of Dr. Nicholas Mantis, we have identified a panel of assays which shows a very promising ability to predict protection in animals. That is, if we draw blood before the animal that is challenged with ricin, testing the blood alone will allow us to predict whether the animal may survive the challenge. Once we have finished testing these methods, we'll be able to use these same methods to test vaccinated humans and demonstrate they can obtain similar levels of immunogenicity. 7. : Lastly and, not to sound like a broken record, but as it relates to the vaccine candidates, how are they better than other options available now? : Our ricin toxin vaccine is the most advanced product. The only other product in this area has been stalled in testing for some years now. Moreover, our product (RiVax) is also the only thermostable option, suggesting that it can be efficiently stockpiled and shipped as needed without concerns about cold chain integrity. For a full list of disclaimers and disclosures, please visit: https://sylvacap.com/disclaimer.


On Monday, shares in San Diego, California headquartered Organovo Holdings Inc. recorded a trading volume of 549,433 shares. The stock ended the session 0.37% higher at $2.72. The Company's shares are trading 7.62% below their 50-day moving average. Moreover, shares of Organovo, which focuses on developing and commercializing functional human tissues that could be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs, have a Relative Strength Index (RSI) of 42.98. On May 01st, 2017, Organovo announced a collaboration with the University of Virginia (UVA) to develop 3D bioprinted tissues for volumetric muscle loss injury. The research will take place in the laboratory of George J. Christ, Ph.D., professor of biomedical engineering and orthopaedic surgery at UVA. The free research report on ONVO is available at: San Diego, California headquartered DexCom Inc.'s stock closed the day 3.69% lower at $73.40. A total volume of 2.17 million shares was traded, which was above their three months average volume of 937,590 shares. The Company's shares have advanced 22.95% since the start of this year. The stock is trading 6.56% below its 50-day moving average. Additionally, shares of DexCom, which together with its subsidiaries, focuses on the design, development, and commercialization of continuous glucose monitoring systems in the US and internationally, have an RSI of 41.31. On May 03rd, 2017, research firm Canaccord Genuity reiterated its 'Buy' rating on the Company's stock with a decrease of the target price from $95 a share to $90 a share. On May 04th, 2017, DexCom announced that its G5 Mobile CGM System can now be used with Apple Watches throughout Europe by downloading the latest version of the G5 Mobile App - iOS 1.6. By adding Apple Watch as another display device, Europeans living with diabetes have even more options to view their glucose readings and alerts on Dexcom's G5 Mobile CGM System to help better manage their diabetes. The complimentary report on DXCM can be downloaded at: Shares in Madison, New Jersey headquartered Quest Diagnostics Inc. recorded a trading volume of 703,163 shares. The stock ended yesterday's trading session 0.09% higher at $107.19. The Company's shares have advanced 9.53% in the past month, 16.06% in the previous three months, and 17.75% on an YTD basis. The stock is trading above its 50-day and 200-day moving averages by 7.40% and 19.47%, respectively. Furthermore, shares of Quest Diagnostics, which provides diagnostic testing information and services in the US and internationally, have an RSI of 78.18. On April 26th, 2017, research firm Mizuho reiterated its 'Buy' rating on the Company's stock with an increase of the target price from $110 a share to $115 a share. On May 01st, 2017, Quest Diagnostics announced that its senior Vice President and Chief Information Officer, Lidia L. Fonseca, has received a 2017 Forbes CIO Innovation Award. The award, presented during the Forbes Innovation Summit on April 24th, 2017, recognizes CIOs of multibillion-dollar companies who have demonstrated the ability to generate value through innovation. Visit us today and download our complete research report on DGX for free at: Burlington, North Carolina headquartered Laboratory Corp. of America Holdings' ("LabCorp®") stock finished Monday's session 0.13% lower at $142.19 with a total trading volume of 499,035 shares. The Company's shares have advanced 9.49% over the previous three months and 10.76% since the start of this year. The stock is trading above its 200-day moving average by 4.81%. Additionally, shares of Laboratory Corp., which operates as an independent clinical laboratory company worldwide, have an RSI of 50.73. On May 04th, 2017, LabCorp® has completed the acquisition of Pathology Associates Medical Laboratories (PAML) from former owners Providence Health & Services and Catholic Health Initiatives. With the acquisition, LabCorp assumes PAML's ownership interests in several joint ventures: Colorado Laboratory Services, Kentucky Laboratory Services, MountainStar Clinical Laboratories, PACLAB Network Laboratories, and Tri-Cities Laboratory.  Get free access to your technical report on LH at: Stock Callers (SC) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. SC has two distinct and independent departments. 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I serve as the CEO of Sylva International, and my firm and I are shareholders of Soligenix. I recently had the opportunity to converse with Dr. Chris Schaber, CEO of Soligenix (NASDAQ: SNGX), regarding the current status and future of Soligenix. I came away from our conversation very excited for a number of reasons, which I will get to shortly. I also asked Dr. Schaber if Dr. Straube (CMO) and Dr. Donini (CSO) would be willing to respond to some questions I had regarding their clinical pipeline. Before getting to the Q&A with Drs. Straube and Donini, I wanted to highlight a subject that came up in my conversation with Dr. Schaber. The subject was the $25M mixed prospectus/shelf that was filed on May 5 th. It seems to me that many investors perceived this prospectus as the company seeking to raise capital immediately and, as such, the share price has been under pressure. For those of you who do not know me, I have been investing in and advising public companies for nearly 20 years. I am a Registered Investment Advisor in my home state of Oregon, as is my firm, Sylva International. In this day and age, any development stage small/microcap public company should have a shelf on file with the SEC, in my opinion, as it may provide the company with considerable optionality and negotiating leverage. Let's address negotiating leverage. Assume a company wishes to acquire Soligenix as a whole, rather than acquire one of the many assets Soligenix owns and is developing. Without an effective shelf registration in place, Soligenix will likely be valued based solely on the cash on their balance sheet (approximately $9M at year end 2016), plus the negotiated value of their assets under development. However, with a $25 million shelf in place, and personally I wish it was a $250 million shelf, Soligenix now has negotiating power and considerable optionality because their stock can be used as an asset to raise capital. When negotiating with a potential acquirer, the financing alternative is leverage that can be used to either strike a better deal for shareholders, or walk away from the transaction altogether. Given Soligenix's new found liquidity, the company could raise $25M tomorrow, should it choose, which means Sologenix will be able to negotiate from a position of strength. Soligenix did not have this optionality just two months ago. To those of you worried about any dilution at the current valuation, per my recent discussion with Dr. Schaber, CEO of Soligenix, there is no plan to raise money as it is not needed. Not to sound like a broken record (remember those?), Dr. Schaber stated emphatically to me that the company has zero intention of raising any money at the current valuation and that Soligenix raised money in December 2016 and, as such, has no pressing need for cash. With that stated, Dr. Schaber also understands what the significant increase in average dollar volume means to Soligenix and that is what has me smiling, as a shareholder! Two months ago, March 9th 2017, the company could not raise $25M money, given the average daily trading volume was a meager 101,355 shares a day over the past 30 calendar days from March 9th to February 9th. The average daily volume in that 30 calendar day period multiplied by the share price on March 9th equated to $236,157 of average daily dollar volume, given the closing price on March 9, 2017 of Soligenix was $2.33. Now, let's fast forward to May 9th, 2017 and the stock closed at $2.55 and average daily trading volume over the past 30 calendar days has been 1,609,836, which equates to $4,105,082 of average daily dollar volume, a MASSIVE difference. This increase in daily dollar trading volume over the past 30 calendar days is of major value for shareholders of Soligenix - allow me to explain why. Let's go back to my hypothetical acquirer looking to buy Soligenix, before the substantial increase of Soligenix average daily dollar trading volume; the hypothetical acquirer would calculate their acquisition price by utilizing a risk adjusted net present value calculation ("NPV"), which essentially takes the estimated value of a stream of future cash flows that result from sales of developed drugs, then discounts that value to a present day figure, and adds cash and cash equivalents that are currently on the company's balance sheet. With a shelf in place, however, a prospective acquirer or partner must take into consideration that Soligenix has the ability to raise $25M, literally overnight, given the increase in average daily dollar trading volume. As a result, the NPV calculation will be adjusted considerably, because the company has viable financing options. In turn, the optionality provides Sologenix with negotiating leverage, making the company A LOT more valuable. For fun, let's assume Soligenix gains FDA approval for SGX942 in Oral Mucositis and launches SGX942 by itself. Many experts have stated that the market for Oral Mucositis is $500M, or greater, annually worldwide. SGX942 has a number of potential benefits that may help those afflicted with Oral Mucositis and, as such, Soligenix may garner a majority, if not all, of the market share for this $500M+ market. So, given that assumption, what is Soligenix worth today? The answer has to be something in excess of the meager $13.95M market cap at which the company now trades. This massive increase in average daily dollar trading volume should be met with cheers versus jeers by shareholders. The reason why it should be cheers versus jeers is because the value of partnering or purchasing Soligenix just went up substantially because of the optionality and leverage Soligenix now has given this increase in average daily dollar volume. Many of you have called or emailed me asking me why the stock price is under pressure, why the company filed a $25M shelf, and what do I think? Well, now you know why I answer the phone downright giddy as it relates to Soligenix, as it sure looks like they are shining! As I mentioned earlier in this article, I conducted a Q&A with Dr. Richard Straube, MD, Chief Medical Officer, Soligenix and Dr. Oreola Donini, PhD, Chief Scientific Officer, Soligenix. As promised, our Q&A is below: 1. Ross Silver: When evaluating the compounds used to manage Oral Mucositis ("OM"), what options currently exist, what do they cost annually, and how do they improve or neutralize OM, if at all? Dr. Richard Straube ("RS"): As you know, oral mucositis (OM) is an extremely debilitating side effect of many cancer treatments. Although there are ways to prevent OM, for some treatments, this may come with the risk of also protecting the tumor. Because the tumor treatment is the primary treatment objective, tumor protection is a major safety issue. There is no approved drug for the treatment of oral mucositis in head and neck cancer (or indeed any "solid" tumor - that is, a tumor affecting an organ rather than the blood). There is only one approved drug for treatment of any type of oral mucositis in hematological cancers. It is called palifermin and it is contraindicated in solid tumors. This is because the treatment (which is actually used prophylactically) is actually a tissue growth factor that could encourage solid tumors to grow. Other "treatments" for OM are not approved drugs, but rather 510k devices - this means that they did not have to show efficacy data to get approved by the FDA. The use of these approaches is considered palliative only and they do not treat the underlying disease. Thus, there are no true treatment options for OM in any solid tumor setting at the current time. Severe OM not only has major impacts on the patient's quality of life and their ability to tolerate a complete course of chemoradiation therapy, it also has a major financial impact. In 2007, it was estimated that head and neck cancer patients that developed severe OM required extra hospitalizations and care that total to about $17,000, and these costs are probably higher today. 2. Ross Silver: SGX942 is what Soligenix is developing to treat OM, and the compound is now in a Phase 3 trial. Can you tell us how SGX942 may improve or neutralize OM? RS: Over years of study, we have come to understand that OM is driven by a dysregulated inflammatory response of the innate immune system. The innate immune system responds to the damage caused by the chemoradiation therapy by triggering an inflammatory signaling cascade, which makes the damage done by the initial chemoradiation even worse. SGX942 is an Innate Defense Regulator. It modulates the innate immune system, enhancing the tissue healing and anti-infective pathways while modulating the inflammatory pathways. Thus, SGX942 deals with the downstream consequences of triggering the innate immune system and thereby prevents the damage from getting worse. Importantly though, it doesn't protect the initial damage to the mucosa that is directly caused by the radiation and chemotherapy, because this would also protect the tumor. The drug is specifically targeted to reduce the amplification of the musical damage caused by the over-exuberant inflammation triggered by this initial insult. It's other actions, bacterial destruction and enhanced tissue healing decrease the duration of the damage that does occur. In the Phase 2 study, we saw a 50% decrease in the duration of severe OM. Severe OM means that the damage to the oral mucosa is so severe the patient has visible ulcers in their mouth and cannot eat and/or drink. We also identified a high risk patient population in the Phase 2 trial, those receiving the highest doses of concomitant chemotherapy, who had a median duration of 30 days of severe OM in the Placebo group - and in this subgroup, treatment with SGX942 (1.5 mg/kg) reduced the duration by 67% (to 10 days). Actually, the Innate Defense Regulators may have some anti-tumor action, as well, but this is not the primary aim of our treatment. Rather, we take this as an encouraging sign that SGX942 will not negatively impact tumor control. In fact, in our Phase 2 study, we saw indications that the SGX942 treatment group (1.5 mg/kg) had a higher rate of complete tumor resolution at the 1-month follow-up visit than the placebo group. We also saw a reduced rate of infection, particularly bacterial (or "non-fungal") infection, also consistent with the mechanism of action. Finally, in the long-term (12 month) follow-up results, which we announced in on December 8, 2016, we also saw a reduced mortality rate in the 1.5 mg/kg SGX942 treated group. I would encourage those reading this interview today to go back and check out the press release. 3. Ross Silver: Is there a possibility SGX942 may eliminate OM? RS: As I noted above, the initial damage to the mouth is done by the chemoradiation therapy that is targeting the tumor, but also causes damage to rapidly dividing cells, such as those found in the mucosa of the mouth. Clearly, this initial damage cannot be "undone" without also protecting the tumor. However, the more severe OM, which is also driven by the innate immune system, certainly can be "undone," and this is the aim of SGX942 treatment. 4. Ross Silver: Switching gears a bit, you have another Phase 3 clinical candidate meant to treat CTCL named SGX301. Can you tell us how SGX301 works and, if approved, what sort of impact the compound may have? RS: SGX301 is a combination product - a topically applied ointment (synthetic hypericin) which is activated by safe, cost-effective fluorescent light. The ointment is applied to the cutaneous T-cell lymphoma lesions (CTCL) for up to 24 hours to allow it to be taken up by the cancerous T-cells in the skin. The following day, the lesion is exposed to fluorescent light for a short period of time (e.g., about 5-10 minutes). The light activates the synthetic hypericin, causing it to release free radicals which induce apoptosis (programmed cell death of the lesion cells only). This is called photodynamic therapy. There is no approved first line treatment for CTCL. There are other photodynamic therapies, which are used off-label, in CTCL - such as PUVA. The distinction here is that this photoactivating agent known as Psoralen is mutagenic and the UVA light used to activate it is carcinogenic; as a result, the product has a BLACK BOX warning for causing other (potentially more fatal) skin cancers, such as melanoma. SGX301 is neither carcinogenic nor mutagenic and is, therefore, potentially much safer to use. This is particularly important because CTCL can be a very slowly progressing disease when appropriately treated, with the need for multiple treatments over years and decades. We expect SGX301 to have a significant impact, if approved, since it will be a very safe therapy for a disease which currently has no available front-line therapy and all secondary therapies come with significant safety concerns. 5. Ross Silver: Soligenix has a robust vaccine program under development that has received nearly $60M in government funding. The Vaccines/BioDefense segment is involved in the development of RiVax, a ricin toxin vaccine candidate, which has completed Phase IB clinical trial for the treatment of vaccine against ricin toxin poisoning; OrbeShield, a GI acute radiation syndrome (GI ARS) therapeutic candidate, which is in pre-clinical stage to treat therapeutics against GI ARS; and SGX943, a melioidosis therapeutic candidate that is in pre-clinical stage for the treatment of melioidosis. Its vaccines are supported by its ThermoVax, a heat stabilization technology. Can you tell us how this heat stabilization technology works? Dr. Oreola Donini ("OD"): Heat stabilization works by "freezing" the protein in a glass-like state with minimal water. This is important because of a lot of protein degradation reactions occur due to water. By minimizing the water, and providing a stable solid state, the protein is protected and remains in its active conformation. While this has long been understood, the presence of aluminum, a common adjuvant in vaccines, causes significant problems with this process. With our proprietary technology, we can even stabilize aluminum-adjuvanted vaccines, and believe there may be even broader applications. The initial use of this technology has been applied to our RiVax® vaccine that, although very effective, was extremely unstable in classic formulations and lost substantial activity over several weeks even in refrigerated conditions. When the vaccine was stabilized using this process, the vaccine was 100% potent after being stored for more than a year at 104°F. 6. Ross Silver: In your most recent press release, you focused on correlates of immune protection. Can you explain what these are and why these are important, particularly in the context of the Animal Rule? OD: As you know, our most advanced thermostabilized vaccine is RiVax®, a vaccine to protect individuals from exposure to ricin. We have tested the antigen (without the thermostablized formulation) in healthy human volunteers and shown it to be safe. We have tested the fully thermostabilized vaccine in animals and shown it to be 100% protective to subsequent ricin exposure, even when the exposure is by aerosol, the most lethal route of exposure. The FDA "Animal Rule" is a way of getting a drug approved for the treatment of diseases or exposures that one cannot ethically generate efficacy data in humans. For example, the RiVax vaccine is designed protect people exposed to ricin, most likely as the result of terrorist or military use of the extremely deadly poison, from dying from the poison. Obviously, it is unethical to conduct a typical clinical trial in which some subjects get the drug and a separate group gets an inactive placebo and then exposed both group to ricin exposure and see how many die in each group. Because the need to prove efficacy in situations in which human trials are ethically impossible but critically needed to protect high-risk groups of people, a common situation with biodefense products, the FDA established a route for Marketing Approval usually referred to as the Animal Rule. Under the Animal Rule you need to demonstrate the following key things: 1. That your treatment is safe in humans; 2. That your treatment is effective in animals; and 3. That you can predict efficacy and dosing in humans based on your animal studies. This means that the disease in animals must mimic the disease in humans and that the response of the animals to your treatment is the same as would be expected in humans and that there is some metric you can use to assess the needed dose in humans. In terms of ricin intoxication - the animal models are very reproducible of the human disease (the toxin kills all cells the same way). We have already demonstrated in a pilot study that non-human primates respond to our vaccine in a similar manner as humans. The last step was to predict the appropriate dose levels to use in humans. In the vaccine world, this means being able to determine a level of immunogenicity in animals that correlates to survival in animals and then show that humans (say in a Phase 1 trial) can achieve the same level of immunogenicity. This last step is the one we have begun to make progress on. With our colleagues at HRI/NYSDOH in the laboratory of Dr. Nicholas Mantis, we have identified a panel of assays which shows a very promising ability to predict protection in animals. That is, if we draw blood before the animal that is challenged with ricin, testing the blood alone will allow us to predict whether the animal may survive the challenge. Once we have finished testing these methods, we'll be able to use these same methods to test vaccinated humans and demonstrate they can obtain similar levels of immunogenicity. 7. Ross Silver: Lastly and, not to sound like a broken record, but as it relates to the vaccine candidates, how are they better than other options available now? OD: Our ricin toxin vaccine is the most advanced product. The only other product in this area has been stalled in testing for some years now. Moreover, our product (RiVax) is also the only thermostable option, suggesting that it can be efficiently stockpiled and shipped as needed without concerns about cold chain integrity. For a full list of disclaimers and disclosures, please visit: https://sylvacap.com/disclaimer. I serve as the CEO of Sylva International, and my firm and I are shareholders of Soligenix. I recently had the opportunity to converse with Dr. Chris Schaber, CEO of Soligenix (NASDAQ: SNGX), regarding the current status and future of Soligenix. I came away from our conversation very excited for a number of reasons, which I will get to shortly. I also asked Dr. Schaber if Dr. Straube (CMO) and Dr. Donini (CSO) would be willing to respond to some questions I had regarding their clinical pipeline. Before getting to the Q&A with Drs. Straube and Donini, I wanted to highlight a subject that came up in my conversation with Dr. Schaber. The subject was the $25M mixed prospectus/shelf that was filed on May 5 th. It seems to me that many investors perceived this prospectus as the company seeking to raise capital immediately and, as such, the share price has been under pressure. For those of you who do not know me, I have been investing in and advising public companies for nearly 20 years. I am a Registered Investment Advisor in my home state of Oregon, as is my firm, Sylva International. In this day and age, any development stage small/microcap public company should have a shelf on file with the SEC, in my opinion, as it may provide the company with considerable optionality and negotiating leverage. Let's address negotiating leverage. Assume a company wishes to acquire Soligenix as a whole, rather than acquire one of the many assets Soligenix owns and is developing. Without an effective shelf registration in place, Soligenix will likely be valued based solely on the cash on their balance sheet (approximately $9M at year end 2016), plus the negotiated value of their assets under development. However, with a $25 million shelf in place, and personally I wish it was a $250 million shelf, Soligenix now has negotiating power and considerable optionality because their stock can be used as an asset to raise capital. When negotiating with a potential acquirer, the financing alternative is leverage that can be used to either strike a better deal for shareholders, or walk away from the transaction altogether. Given Soligenix's new found liquidity, the company could raise $25M tomorrow, should it choose, which means Sologenix will be able to negotiate from a position of strength. Soligenix did not have this optionality just two months ago. To those of you worried about any dilution at the current valuation, per my recent discussion with Dr. Schaber, CEO of Soligenix, there is no plan to raise money as it is not needed. Not to sound like a broken record (remember those?), Dr. Schaber stated emphatically to me that the company has zero intention of raising any money at the current valuation and that Soligenix raised money in December 2016 and, as such, has no pressing need for cash. With that stated, Dr. Schaber also understands what the significant increase in average dollar volume means to Soligenix and that is what has me smiling, as a shareholder! Two months ago, March 9th 2017, the company could not raise $25M money, given the average daily trading volume was a meager 101,355 shares a day over the past 30 calendar days from March 9th to February 9th. The average daily volume in that 30 calendar day period multiplied by the share price on March 9th equated to $236,157 of average daily dollar volume, given the closing price on March 9, 2017 of Soligenix was $2.33. Now, let's fast forward to May 9th, 2017 and the stock closed at $2.55 and average daily trading volume over the past 30 calendar days has been 1,609,836, which equates to $4,105,082 of average daily dollar volume, a MASSIVE difference. This increase in daily dollar trading volume over the past 30 calendar days is of major value for shareholders of Soligenix - allow me to explain why. Let's go back to my hypothetical acquirer looking to buy Soligenix, before the substantial increase of Soligenix average daily dollar trading volume; the hypothetical acquirer would calculate their acquisition price by utilizing a risk adjusted net present value calculation ("NPV"), which essentially takes the estimated value of a stream of future cash flows that result from sales of developed drugs, then discounts that value to a present day figure, and adds cash and cash equivalents that are currently on the company's balance sheet. With a shelf in place, however, a prospective acquirer or partner must take into consideration that Soligenix has the ability to raise $25M, literally overnight, given the increase in average daily dollar trading volume. As a result, the NPV calculation will be adjusted considerably, because the company has viable financing options. In turn, the optionality provides Sologenix with negotiating leverage, making the company A LOT more valuable. For fun, let's assume Soligenix gains FDA approval for SGX942 in Oral Mucositis and launches SGX942 by itself. Many experts have stated that the market for Oral Mucositis is $500M, or greater, annually worldwide. SGX942 has a number of potential benefits that may help those afflicted with Oral Mucositis and, as such, Soligenix may garner a majority, if not all, of the market share for this $500M+ market. So, given that assumption, what is Soligenix worth today? The answer has to be something in excess of the meager $13.95M market cap at which the company now trades. This massive increase in average daily dollar trading volume should be met with cheers versus jeers by shareholders. The reason why it should be cheers versus jeers is because the value of partnering or purchasing Soligenix just went up substantially because of the optionality and leverage Soligenix now has given this increase in average daily dollar volume. Many of you have called or emailed me asking me why the stock price is under pressure, why the company filed a $25M shelf, and what do I think? Well, now you know why I answer the phone downright giddy as it relates to Soligenix, as it sure looks like they are shining! As I mentioned earlier in this article, I conducted a Q&A with Dr. Richard Straube, MD, Chief Medical Officer, Soligenix and Dr. Oreola Donini, PhD, Chief Scientific Officer, Soligenix. As promised, our Q&A is below: 1. Ross Silver: When evaluating the compounds used to manage Oral Mucositis ("OM"), what options currently exist, what do they cost annually, and how do they improve or neutralize OM, if at all? Dr. Richard Straube ("RS"): As you know, oral mucositis (OM) is an extremely debilitating side effect of many cancer treatments. Although there are ways to prevent OM, for some treatments, this may come with the risk of also protecting the tumor. Because the tumor treatment is the primary treatment objective, tumor protection is a major safety issue. There is no approved drug for the treatment of oral mucositis in head and neck cancer (or indeed any "solid" tumor - that is, a tumor affecting an organ rather than the blood). There is only one approved drug for treatment of any type of oral mucositis in hematological cancers. It is called palifermin and it is contraindicated in solid tumors. This is because the treatment (which is actually used prophylactically) is actually a tissue growth factor that could encourage solid tumors to grow. Other "treatments" for OM are not approved drugs, but rather 510k devices - this means that they did not have to show efficacy data to get approved by the FDA. The use of these approaches is considered palliative only and they do not treat the underlying disease. Thus, there are no true treatment options for OM in any solid tumor setting at the current time. Severe OM not only has major impacts on the patient's quality of life and their ability to tolerate a complete course of chemoradiation therapy, it also has a major financial impact. In 2007, it was estimated that head and neck cancer patients that developed severe OM required extra hospitalizations and care that total to about $17,000, and these costs are probably higher today. 2. Ross Silver: SGX942 is what Soligenix is developing to treat OM, and the compound is now in a Phase 3 trial. Can you tell us how SGX942 may improve or neutralize OM? RS: Over years of study, we have come to understand that OM is driven by a dysregulated inflammatory response of the innate immune system. The innate immune system responds to the damage caused by the chemoradiation therapy by triggering an inflammatory signaling cascade, which makes the damage done by the initial chemoradiation even worse. SGX942 is an Innate Defense Regulator. It modulates the innate immune system, enhancing the tissue healing and anti-infective pathways while modulating the inflammatory pathways. Thus, SGX942 deals with the downstream consequences of triggering the innate immune system and thereby prevents the damage from getting worse. Importantly though, it doesn't protect the initial damage to the mucosa that is directly caused by the radiation and chemotherapy, because this would also protect the tumor. The drug is specifically targeted to reduce the amplification of the musical damage caused by the over-exuberant inflammation triggered by this initial insult. It's other actions, bacterial destruction and enhanced tissue healing decrease the duration of the damage that does occur. In the Phase 2 study, we saw a 50% decrease in the duration of severe OM. Severe OM means that the damage to the oral mucosa is so severe the patient has visible ulcers in their mouth and cannot eat and/or drink. We also identified a high risk patient population in the Phase 2 trial, those receiving the highest doses of concomitant chemotherapy, who had a median duration of 30 days of severe OM in the Placebo group - and in this subgroup, treatment with SGX942 (1.5 mg/kg) reduced the duration by 67% (to 10 days). Actually, the Innate Defense Regulators may have some anti-tumor action, as well, but this is not the primary aim of our treatment. Rather, we take this as an encouraging sign that SGX942 will not negatively impact tumor control. In fact, in our Phase 2 study, we saw indications that the SGX942 treatment group (1.5 mg/kg) had a higher rate of complete tumor resolution at the 1-month follow-up visit than the placebo group. We also saw a reduced rate of infection, particularly bacterial (or "non-fungal") infection, also consistent with the mechanism of action. Finally, in the long-term (12 month) follow-up results, which we announced in on December 8, 2016, we also saw a reduced mortality rate in the 1.5 mg/kg SGX942 treated group. I would encourage those reading this interview today to go back and check out the press release. 3. Ross Silver: Is there a possibility SGX942 may eliminate OM? RS: As I noted above, the initial damage to the mouth is done by the chemoradiation therapy that is targeting the tumor, but also causes damage to rapidly dividing cells, such as those found in the mucosa of the mouth. Clearly, this initial damage cannot be "undone" without also protecting the tumor. However, the more severe OM, which is also driven by the innate immune system, certainly can be "undone," and this is the aim of SGX942 treatment. 4. Ross Silver: Switching gears a bit, you have another Phase 3 clinical candidate meant to treat CTCL named SGX301. Can you tell us how SGX301 works and, if approved, what sort of impact the compound may have? RS: SGX301 is a combination product - a topically applied ointment (synthetic hypericin) which is activated by safe, cost-effective fluorescent light. The ointment is applied to the cutaneous T-cell lymphoma lesions (CTCL) for up to 24 hours to allow it to be taken up by the cancerous T-cells in the skin. The following day, the lesion is exposed to fluorescent light for a short period of time (e.g., about 5-10 minutes). The light activates the synthetic hypericin, causing it to release free radicals which induce apoptosis (programmed cell death of the lesion cells only). This is called photodynamic therapy. There is no approved first line treatment for CTCL. There are other photodynamic therapies, which are used off-label, in CTCL - such as PUVA. The distinction here is that this photoactivating agent known as Psoralen is mutagenic and the UVA light used to activate it is carcinogenic; as a result, the product has a BLACK BOX warning for causing other (potentially more fatal) skin cancers, such as melanoma. SGX301 is neither carcinogenic nor mutagenic and is, therefore, potentially much safer to use. This is particularly important because CTCL can be a very slowly progressing disease when appropriately treated, with the need for multiple treatments over years and decades. We expect SGX301 to have a significant impact, if approved, since it will be a very safe therapy for a disease which currently has no available front-line therapy and all secondary therapies come with significant safety concerns. 5. Ross Silver: Soligenix has a robust vaccine program under development that has received nearly $60M in government funding. The Vaccines/BioDefense segment is involved in the development of RiVax, a ricin toxin vaccine candidate, which has completed Phase IB clinical trial for the treatment of vaccine against ricin toxin poisoning; OrbeShield, a GI acute radiation syndrome (GI ARS) therapeutic candidate, which is in pre-clinical stage to treat therapeutics against GI ARS; and SGX943, a melioidosis therapeutic candidate that is in pre-clinical stage for the treatment of melioidosis. Its vaccines are supported by its ThermoVax, a heat stabilization technology. Can you tell us how this heat stabilization technology works? Dr. Oreola Donini ("OD"): Heat stabilization works by "freezing" the protein in a glass-like state with minimal water. This is important because of a lot of protein degradation reactions occur due to water. By minimizing the water, and providing a stable solid state, the protein is protected and remains in its active conformation. While this has long been understood, the presence of aluminum, a common adjuvant in vaccines, causes significant problems with this process. With our proprietary technology, we can even stabilize aluminum-adjuvanted vaccines, and believe there may be even broader applications. The initial use of this technology has been applied to our RiVax® vaccine that, although very effective, was extremely unstable in classic formulations and lost substantial activity over several weeks even in refrigerated conditions. When the vaccine was stabilized using this process, the vaccine was 100% potent after being stored for more than a year at 104°F. 6. Ross Silver: In your most recent press release, you focused on correlates of immune protection. Can you explain what these are and why these are important, particularly in the context of the Animal Rule? OD: As you know, our most advanced thermostabilized vaccine is RiVax®, a vaccine to protect individuals from exposure to ricin. We have tested the antigen (without the thermostablized formulation) in healthy human volunteers and shown it to be safe. We have tested the fully thermostabilized vaccine in animals and shown it to be 100% protective to subsequent ricin exposure, even when the exposure is by aerosol, the most lethal route of exposure. The FDA "Animal Rule" is a way of getting a drug approved for the treatment of diseases or exposures that one cannot ethically generate efficacy data in humans. For example, the RiVax vaccine is designed protect people exposed to ricin, most likely as the result of terrorist or military use of the extremely deadly poison, from dying from the poison. Obviously, it is unethical to conduct a typical clinical trial in which some subjects get the drug and a separate group gets an inactive placebo and then exposed both group to ricin exposure and see how many die in each group. Because the need to prove efficacy in situations in which human trials are ethically impossible but critically needed to protect high-risk groups of people, a common situation with biodefense products, the FDA established a route for Marketing Approval usually referred to as the Animal Rule. Under the Animal Rule you need to demonstrate the following key things: 1. That your treatment is safe in humans; 2. That your treatment is effective in animals; and 3. That you can predict efficacy and dosing in humans based on your animal studies. This means that the disease in animals must mimic the disease in humans and that the response of the animals to your treatment is the same as would be expected in humans and that there is some metric you can use to assess the needed dose in humans. In terms of ricin intoxication - the animal models are very reproducible of the human disease (the toxin kills all cells the same way). We have already demonstrated in a pilot study that non-human primates respond to our vaccine in a similar manner as humans. The last step was to predict the appropriate dose levels to use in humans. In the vaccine world, this means being able to determine a level of immunogenicity in animals that correlates to survival in animals and then show that humans (say in a Phase 1 trial) can achieve the same level of immunogenicity. This last step is the one we have begun to make progress on. With our colleagues at HRI/NYSDOH in the laboratory of Dr. Nicholas Mantis, we have identified a panel of assays which shows a very promising ability to predict protection in animals. That is, if we draw blood before the animal that is challenged with ricin, testing the blood alone will allow us to predict whether the animal may survive the challenge. Once we have finished testing these methods, we'll be able to use these same methods to test vaccinated humans and demonstrate they can obtain similar levels of immunogenicity. 7. Ross Silver: Lastly and, not to sound like a broken record, but as it relates to the vaccine candidates, how are they better than other options available now? OD: Our ricin toxin vaccine is the most advanced product. The only other product in this area has been stalled in testing for some years now. Moreover, our product (RiVax) is also the only thermostable option, suggesting that it can be efficiently stockpiled and shipped as needed without concerns about cold chain integrity. For a full list of disclaimers and disclosures, please visit: https://sylvacap.com/disclaimer.

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