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"There is a sense of connection with the music when one's listening to vinyl that is not replicable with any other format. It's not just hipster nostalgia – there is a real, visceral thing that happens," says Matt Watts, director of music and marketing for Hard Rock Hotels & Casinos. "With WAX, Hard Rock wants guest to experience that magic right there in their hotel rooms. Whether they grew up listening to vinyl or are just now getting turned on to its unique vibes for the first time, the WAX program is a perfect vehicle for one's vinyl journey." To celebrate the Sound of Your Stay® and its latest offering, Hard Rock has also partnered with five buzzed-about, emerging artists to help amplify the launch by featuring exclusive pictures, video content, live performances and integration of each artists' latest records into the WAX collection for guests to enjoy at leisure. Artists include New Politics, who have been lighting up the airwaves with new hit single, "One of Us," showcasing their blend of punk, pop and electronically induced dance rock on tour with 311 this summer; The Aces, comprised of four girls taking the musical realm by storm with their newly released video for "Physical"; Evan Rachel Wood and Zach Villa's Rebel and a Basketcase, fusing an anthemic electronic pop sound with androgynous glam to bring a larger-than-life aesthetic with new single "Today" –  influenced by both 80's pop and rock, as well as today's alternative music; Run River North, a Korean-American indie folk-rock band from Los Angeles who have truly made a name for themselves with their breakout single "Run or Hide;" in addition to Grammy award-winning, veteran singer and songwriter Michelle Branch who recently released her most fully realized artistic statement yet with album "Hopeless Romantic." "Rebel and a Basketcase and Hard Rock share an affinity for inspired choices. With our new record coming out this summer, the Sound of Your Stay program provides an unparalleled opportunity for us to personally connect with our fans," said Rebel and a Basketcase's Evan Rachel Wood and Zach Villa. Appealing to the modern business or leisure traveler, the elements of The Sound of Your Stay® create an unparalleled, authentic, hands-on experience, allowing guests to channel their inner rock star – whether setting the mood with complimentary vinyl record or nailing power chords on a Fender guitar during an in-room jam session. For more information or to book a stay at any of the Hard Rock Hotels & Casinos, please visit www.hardrockhotels.com. With venues in 75 countries, including 175 cafes, 24 hotels and 11 casinos, Hard Rock International (HRI) is one of the most globally recognized companies. Beginning with an Eric Clapton guitar, Hard Rock owns the world's greatest collection of music memorabilia, which is displayed at its locations around the globe. Hard Rock is also known for its collectible fashion and music-related merchandise, Hard Rock Live performance venues and an award-winning website. HRI owns the global trademark for all Hard Rock brands. The company owns, operates and franchises Cafes in iconic cities including London, New York, San Francisco, Sydney and Dubai. HRI also owns, licenses and/or manages hotel/casino properties worldwide. Destinations include the company's two most successful Hotel and Casino properties in Tampa and Hollywood, Fl., both owned and operated by HRI parent company The Seminole Tribe of Florida, as well as other exciting locations including Bali, Chicago, Cancun, Ibiza, Las Vegas, Macau and San Diego. Upcoming new Hard Rock Cafe locations include Valencia, Innsbruck, Andorra la Vella and Chengdu. New Hard Rock Hotel projects include Abu Dhabi, Atlanta, Berlin, Dubai, London, Los Cabos, New York City, and Shenzhen, Dalian and Haikou in China. For more information on Hard Rock International, visit www.hardrock.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/hard-rock-international-amplifies-the-sound-of-your-stay-with-launch-of-wax-music-amenity-program-300456819.html


News Article | May 10, 2017
Site: www.eurekalert.org

Washington, DC (May 10, 2017) Most human interactions with robots come from behind a screen. Whether it's fiction or a real-life interaction, rarely are we put face to face with a robot. This poses a significant barrier when we look towards a future where robots will be part of our everyday lives. How do we break down this barrier? A recent study by researchers at the University of Koblenz-Landau, University of Wurzburg, and Arts Electronica Futurelab, found that people who watched live interactions with a robot were more likely to consider the robot to have more human-like qualities. Constanze Schreiner (University of Koblenz-Landau), Martina Mara (Ars Electronica Futuerlab), and Markus Appel (University of Wurzburg) will present their findings at the 67th Annual Conference of the International Communication Association in San Diego, CA. Using a Roboy robot, participants observed one of three experimental human robot interactons (HRI); either in real life, in virtual reality (VR) on a 3D screen, or on a 2D screen. The scripted HRI between Roboy and the human technician was 4:25 minutes long. During that time, participants saw Roboy assisting the human in organizing appointments, conducting web searches and finding a birthday present for his mom. The data analyzed revealed that observing a live interaction or alternatively encountering the robot in a VR lead to more perceived realness. Furthermore, the kind of presentation influenced perceived human-likeness. Participants who observed a real HRI reported the highest perceived human-likeness. Particularly interesting is that participants who were introduced to Roboy in VR perceived the robot as less human-like than participants who watched a live HRI, whereas these two groups did not differentiate in regard of perceived realness. Usually, experimental studies interested in HRI and participants' evaluations of humanoid service robots - due to limited resources - need to fall back on video stimuli. This is the first study using participants' evaluations of a humanoid service robot when observed either on a 2D video, in 3D virtual reality, or in real life. "Many people will have their first encounter with a service robot over the next decade. Service robots are designed to communicate with humans in humanlike ways and assist them in various aspects of their daily routine. Potential areas of application range from hospitals and nursing homes to hotels and the users' households," said Schreiner. "To date, however, most people still only know such robots from the Internet or TV and are still skeptical about the idea of sharing their personal lives with robots, especially when it comes to machines of highly human-like appearance." "When R2-D2 Hops off the Screen: A Service Robot Encountered in Real Life Appears More Real and Humanlike Than on Video or in VR," by Constanze Schreiner, Martina Mara, and Markus Appel; to be presented at the 67th Annual International Communication Association Conference, San Diego, CA, 25-29 May 2017. Contact: To schedule an interview with the author or request a copy of the research, please contact John Paul Gutierrez, jpgutierrez@icahdq.org. The International Communication Association is an academic association for scholars interested in the study, teaching, and application of all aspects of human and mediated communication. With more than 4,300 members in 80 countries, ICA includes 31 Divisions and Interest Groups and publishes the Annals of the International Communication Association and five major, peer-reviewed journals: Journal of Communication, Communication Theory, Human Communication Research, Communication, Culture & Critique, and the Journal of Computer-Mediated Communication. For more information, visit http://www. .


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

BONITA SPRINGS, Fla.--(BUSINESS WIRE)--Herc Holdings Inc. (NYSE: HRI) ("Herc Holdings" or the "Company") today reported financial results for the quarter ended March 31, 2017. Equipment rental revenues were $320.6 million and total revenues were $389.4 million in the first quarter of 2017, up from $307.8 million and $365.6 million, respectively, for the same period last year. The Company reported a net loss of $39.2 million, or $1.39 per diluted share, in the first quarter of 2017, compared to a net loss of $1.5 million, or $0.05 per diluted share, for the same period last year. Equipment rental revenues increased 4.2% and pricing improved 1.1% in the first quarter of 2017 compared to the prior year period. Rental revenues in key markets, excluding currency, increased 8.5% and pricing improved 1.7%, compared to the first quarter 2016. The first quarter net loss reflected an increase of $31.3 million in interest expense related to debt issued in June 2016, stand-alone public company and other costs, and continued weakness in upstream oil and gas markets. "Our revenues and pricing were strong in the first quarter despite the industry's normal seasonality and continuing headwinds in upstream oil and gas," said Larry Silber, president and chief executive officer. "Rental revenue growth in key markets was particularly robust, and we remain confident in our strategy. The continuing progress we are making in expanding our customer base and increasing revenue in key markets was offset by the impact of stand-alone public company costs, certain business transformation and other costs, and investments in our sales organization and branch operations. "Our strategy is on track as we continue to shift our fleet mix to include a greater variety of higher dollar utilization fleet. In addition, net fleet capital expenditures reflect our disciplined approach to capital management through well-managed fleet rotation. We expect to deliver improved EBITDA margins over time as our expansion in high-growth, urban markets offers opportunities to outperform overall equipment rental industry growth rates." "We are affirming our 2017 adjusted EBITDA and net fleet capital expenditures guidance, which, as we indicated previously, is based on a 3.5% growth rate in the North American equipment market," said Silber. The Company does not provide forward-looking guidance for certain financial measures on a GAAP basis or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures on a forward-looking basis because it is unable to predict certain items contained in the GAAP measures without unreasonable efforts. Certain items that impact net income (loss) cannot be predicted with reasonable certainty, such as restructuring and restructuring related charges, special tax items, borrowing levels (which affect interest expense), gains and losses from asset sales, the ultimate outcome of pending litigation and spin-related costs. Herc Holdings' first quarter 2017 earnings webcast will be held today at 8:30 a.m. U.S. Eastern Time. Interested U.S. parties may call +1-877-883-0383 and international participants should call +1-412-902-6506, using the access code: 7526477. Please dial in at least 10 minutes before the call start time to ensure that you are connected to the call and to register your name and company. Those who wish to listen to the live conference call and view the accompanying presentation slides should visit the Events and Presentations tab of the Investor Relations section of the Company's website at IR.HercRentals.com. The press release and presentation slides for the call will be posted to this section of the website prior to the call. A replay of the conference call will be available via webcast on the company website at IR.HercRentals.com, where it will be archived for 90 days after the call. A telephonic replay will be available for one week. To listen to the archived call by telephone, U.S. participants should dial +1-877-344-7529 and international participants +1-412-317-0088 and enter conference ID number 10105408. Herc Holdings Inc., which operates through its Herc Rentals Inc. subsidiary, is one of the leading equipment rental suppliers with approximately 275 company-operated locations, principally in North America. With more than 50 years of experience, Herc Holdings is a full-line equipment rental supplier in key markets, including commercial and residential construction, industrial and manufacturing, civil infrastructure, automotive, government and municipalities, energy, remediation, emergency response, facilities, entertainment and agriculture, as well as refineries and petrochemicals. The equipment rental business is supported by ProSolutionsTM (our industry-specific solutions-based services), and our professional grade tools, commercial vehicles, and pump, power and climate control product offerings, all of which are aimed at helping customers work more efficiently, effectively and safely. The Company has approximately 4,800 employees. Herc Holdings’ 2016 total revenues were approximately $1.6 billion. All references to “Herc Holdings” or the “Company” in this press release refer to Herc Holdings Inc. and its subsidiaries, unless otherwise indicated. For more information on Herc Holdings and its products and services, visit: www.HercRentals.com. In this release we refer to the following operating measures: The financial information included in this press release is based upon the condensed consolidated financial statements of the Company which are presented on a basis of accounting that reflects a change in reporting entity and have been adjusted for the effects of the spin-off, which effected our separation from Hertz Rental Car Holding Company, Inc. (“New Hertz”). These financial statements and financial information represent only those operations, assets, liabilities and equity that form Herc Holdings on a stand-alone basis. Since the spin-off occurred on June 30, 2016, prior period amounts represent carve-out financial results. This release contains statements, including those under "2017 Guidance," that are not statements of historical fact, but instead are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We caution readers not to place undue reliance on these statements, which speak only as of the date hereof. There are a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from those suggested by our forward-looking statements, including: All forward-looking statements are expressly qualified in their entirety by such cautionary statements. We do not undertake any obligation to release publicly any update or revision to any of the forward-looking statements. In addition to results calculated according to accounting principles generally accepted in the United States (“GAAP”), the Company has provided certain information in this release which is not calculated according to GAAP (“non-GAAP”), such as adjusted EBITDA. Management uses these non-GAAP measures to evaluate operating performance and period-over-period performance of our core business without regard to potential distortions, and believes that investors will likewise find these non-GAAP measures useful in evaluating the Company’s performance. These measures are frequently used by security analysts, institutional investors and other interested parties in the evaluation of companies in our industry. Non-GAAP measures should not be considered in isolation or as a substitute for our reported results prepared in accordance with GAAP and, as calculated, may not be comparable to similarly titled measures of other companies. For the definitions of these terms, further information about management’s use of these measures as well as a reconciliation of these non-GAAP measures to the most comparable GAAP financial measures, please see the supplemental schedules that accompany this release. EBITDA and Adjusted EBITDA are not recognized terms under GAAP and should not be considered in isolation or as a substitute for our reported results prepared in accordance with GAAP. Further, since all companies do not use identical calculations, our definition and presentation of these measures may not be comparable to similarly titled measures reported by other companies. EBITDA and Adjusted EBITDA - EBITDA represents the sum of net income (loss), provision for income taxes, interest expense, net, depreciation of revenue earning equipment and non-rental depreciation and amortization. Adjusted EBITDA represents EBITDA plus the sum of merger and acquisition related costs, restructuring and restructuring related charges, spin-off costs, non-cash stock based compensation charges, loss on extinguishment of debt (which is included in interest expense, net), impairment charges, gain on the disposal of a business and certain other items. Management uses EBITDA and adjusted EBITDA to evaluate operating performance and period-over-period performance of our core business without regard to potential distortions, and believes that investors will likewise find these non-GAAP measures useful in evaluating the Company's performance. These measures are frequently used by security analysts, institutional investors and other interested parties in the evaluation of companies in our industry. However, EBITDA and Adjusted EBITDA do not purport to be alternatives to net earnings as an indicator of operating performance. Additionally, neither measure purports to be an alternative to cash flows from operating activities as a measure of liquidity, as they do not consider certain cash requirements such as interest payments and tax payments. The reconciliation of EBITDA and Adjusted EBITDA to net income (loss) is presented below:


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.


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.


"The days of searching endlessly online for the lowest price are no longer necessary, when booking direct saves time, money, and allows our fans to focus on the anticipated excitement of their upcoming stay," said Amy Ceriani-Nelson, director of loyalty marketing, Hard Rock International. "We want to thank our loyal Hard Rock Rewards members and ensure they are receiving the best possible rate when choosing to stay with us," said Nora Swire, senior director of marketing, Hard Rock Hotels & Casinos. "From the moment our guests begin the booking process, to the second they step foot onto the property, our team is dedicated to creating an experience that rocks." To become a member of Hard Rock Rewards®, fans simply sign up at hardrockrewards.com. Along with guaranteed low prices, members can enjoy the benefit of dedicated check in-lines, late check-outs, ability to earn hotel points towards free night stays, complimentary welcome amenities at participating hotels, and are able to manage account details on hardrockrewards.com. For more information on Hard Rock International or Hard Rock Rewards, please visit www.hardrock.com. With venues in 74 countries, including 174 cafes, 24 hotels and 11 casinos, Hard Rock International (HRI) is one of the most globally recognized companies. Beginning with an Eric Clapton guitar, Hard Rock owns the world's greatest collection of music memorabilia, which is displayed at its locations around the globe. Hard Rock is also known for its collectible fashion and music-related merchandise, Hard Rock Live performance venues and an award-winning website. HRI owns the global trademark for all Hard Rock brands. The company owns, operates and franchises Cafes in iconic cities including London, New York, San Francisco, Sydney and Dubai. HRI also owns, licenses and/or manages hotel/casino properties worldwide. Destinations include the company's two most successful Hotel and Casino properties in Tampa and Hollywood, Fl., both owned and operated by HRI parent company The Seminole Tribe of Florida, as well as other exciting locations including Bali, Chicago, Cancun, Ibiza, Las Vegas, Macau and San Diego. Upcoming new Hard Rock Cafe locations include Valencia, Innsbruck, Yangon and Chengdu. New Hard Rock Hotel projects include Abu Dhabi, Atlanta, Berlin, Dubai, London, Los Cabos, New York City, and Shenzhen, Dalian and Haikou in China. For more information on Hard Rock International, visit www.hardrock.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/hard-rock-hotels--casinos-puts-guests-first-with-new-hard-rock-rewards-member-only-rate-300454194.html


Most human interactions with robots come from behind a screen. Whether it's fiction or a real-life interaction, rarely are we put face to face with a robot. This poses a significant barrier when we look towards a future where robots will be part of our everyday lives. How do we break down this barrier? A recent study by researchers at the University of Koblenz-Landau, University of Wurzburg, and Arts Electronica Futurelab, found that people who watched live interactions with a robot were more likely to consider the robot to have more human-like qualities. Constanze Schreiner (University of Koblenz-Landau), Martina Mara (Ars Electronica Futuerlab), and Markus Appel (University of Wurzburg) will present their findings at the 67th Annual Conference of the International Communication Association in San Diego, CA. Using a Roboy robot, participants observed one of three experimental human robot interactons (HRI); either in real life, in virtual reality (VR) on a 3D screen, or on a 2D screen. The scripted HRI between Roboy and the human technician was 4:25 minutes long. During that time, participants saw Roboy assisting the human in organizing appointments, conducting web searches and finding a birthday present for his mom. The data analyzed revealed that observing a live interaction or alternatively encountering the robot in a VR lead to more perceived realness. Furthermore, the kind of presentation influenced perceived human-likeness. Participants who observed a real HRI reported the highest perceived human-likeness. Particularly interesting is that participants who were introduced to Roboy in VR perceived the robot as less human-like than participants who watched a live HRI, whereas these two groups did not differentiate in regard of perceived realness. Usually, experimental studies interested in HRI and participants' evaluations of humanoid service robots - due to limited resources - need to fall back on video stimuli. This is the first study using participants' evaluations of a humanoid service robot when observed either on a 2D video, in 3D virtual reality, or in real life. "Many people will have their first encounter with a service robot over the next decade. Service robots are designed to communicate with humans in humanlike ways and assist them in various aspects of their daily routine. Potential areas of application range from hospitals and nursing homes to hotels and the users' households," said Schreiner. "To date, however, most people still only know such robots from the Internet or TV and are still skeptical about the idea of sharing their personal lives with robots, especially when it comes to machines of highly human-like appearance." "When R2-D2 Hops off the Screen: A Service Robot Encountered in Real Life Appears More Real and Humanlike Than on Video or in VR," by Constanze Schreiner, Martina Mara, and Markus Appel; to be presented at the 67th Annual International Communication Association Conference, San Diego, CA, 25-29 May 2017. Explore further: Image: Controlling robots at the Human Robot Interaction Laboratory


News Article | February 28, 2017
Site: www.prnewswire.co.uk

THE 370-ROOM HARD ROCK HOTEL MALTA IS SLATED TO OPEN IN 2020 ORLANDO, Florida, Feb. 28, 2017 /PRNewswire/ -- Hard Rock International announces plans to open its third European resort, following debuts in Ibiza and Tenerife. Projected to open in 2020, the seafront Hard Rock Hotel Malta will feature 370 rooms, including 110 suites offering balcony views. The upcoming project will be part of a new mix-used development called db City Centre, which includes a shopping mall, luxury residences and modern office spaces, in the highly sought after area of St. George's Bay, St. Julian's. Hard Rock Hotel Malta is being developed in collaboration with the Malta-based Seabank Group, a partner of Hard Rock for more than 15 years. "Seabank is recognized as one of the most established hospitality companies on the island with more than 30 years of experience, which includes the ongoing management of Malta's existing Hard Rock Cafes," says Marco Roca, executive vice president of global hotel development at Hard Rock International. "Malta draws in travelers from around the world given its central Mediterranean location, idyllic charm, rich cultural history and vast array of activities – from scuba diving to exploring prehistoric temples – and we are thrilled to be part of a project that will provide travelers and locals with the country's first true entertainment destination." The upcoming Hard Rock Hotel Malta will pay homage to the 19th century British military accommodation quarters building which will be a key feature of the project's design and layout. Prior to opening, the historic site will be restored to its original glory. "In the past few years we've seen Malta's tourism sector on a steady rise, with the destination reporting nearly two million visitors in 2016," says Arthur Gauci, chief executive officer of Seabank Group. "As the world takes notice and Maltese tourism booms, we're thrilled to work with Hard Rock to bring an upscale and never-before-seen experience to the island." Catering to the unique needs of international business and leisure travelers, Hard Rock Hotel Malta will have no shortage of amenities to offer. The hotel will host various high-end food and beverage establishments, including a multi-course signature restaurant and a rooftop lounge complete with Skybar. Guests seeking to relax and retune will enjoy numerous pools and the 16,000 square feet full-service Rock Spa, as well as the state-of-the-art Body Rock fitness center. The upcoming project is set to also host a broad range of events and groups with more than 37,000 square feet of planned function space, including the largest convention center on the island. From conception to completion, the project is expected to generate 1,500 new direct jobs, and an even higher number of indirect employment opportunities. Through music appreciation and an imaginative environment, Hard Rock Hotels & Casinos delivers products for the varied aspects of life – work, play and personal sanctuary. For more information or to book a stay at any of the Hard Rock Hotels & Casinos, please visit www.hardrockhotels.com. With venues in 74 countries, including 174 cafes, 24 hotels and 11 casinos, Hard Rock International (HRI) is one of the most globally recognized companies. Beginning with an Eric Clapton guitar, Hard Rock owns the world's greatest collection of music memorabilia, which is displayed at its locations around the globe. Hard Rock is also known for its collectible fashion and music-related merchandise, Hard Rock Live performance venues and an award-winning website. HRI owns the global trademark for all Hard Rock brands. The company owns, operates and franchises Cafes in iconic cities including London, New York, San Francisco, Sydney and Dubai. HRI also owns, licenses and/or manages hotel/casino properties worldwide. Destinations include the company's two most successful Hotel and Casino properties in Tampa and Hollywood, Fl., both owned and operated by HRI parent company The Seminole Tribe of Florida, as well as other exciting locations including Bali, Chicago, Cancun, Ibiza, Las Vegas, Macau and San Diego. Upcoming new Hard Rock Cafe locations include Valencia, Innsbruck, Yangon and Chengdu. New Hard Rock Hotel projects include Abu Dhabi, Atlanta, Berlin, Dubai, London, Los Cabos, New York City, and Shenzhen, Dalian and Haikou in China. For more information on Hard Rock International, visit www.hardrock.com. The db Group (formerly known as the Seabank Group) is now Malta's leading driver in the tourism, hospitality and leisure market. Started off by Silvio Debono, a waiter, the Group now operates its own chain of db Hotels, has been successfully running the Hard Rock Cafe franchise from three outlets for the last fifteen years and has widened its portfolio to include contract catering, healthcare services, and construction amongst others.


Minneapolis, MN, Feb. 21, 2017 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing the PURE EP(TM) System, a proprietary platform designed to address an unmet technology need for the $4 billion electrophysiology (EP) marketplace, announced that the manuscript entitled, “Novel Electrophysiology Signal Recording System Enables Specific Visualization of Purkinje Network and Other High-Frequency Signals” published in the Journal of the American College of Cardiology (JACC): Clinical Electrophysiology is in the top 5 most read, discussed and shared articles in 2016. BioSig Executive Chairman, Kenneth Londoner stated, “BioSig is very honored to have this article recognized by the Clinical Electrophysiology community. We have paid special focus on EP signals which are difficult to detect in today’s practice; and we are committed to continuing efforts toward our goal of improving upon diagnoses and ablation treatments for patients with complex arrhythmias.” Please visit link to Top Read Articles in JACC 2016 BioSig Technologies is a medical device company developing a proprietary technology platform designed to improve the $4 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to ommercialize its PURE EP(TM) System. BioSig’s technology has been developed to address an unmet need in a large and growing market. The PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. Data from the 2016 HRI Global Opportunities in Medical Devices & Diagnostics report shows the global Electrophysiology (EP) market revenues will grow nearly 10% annually, from currently $4 billion to approximately $6 billion by 2020 with accompanying procedure growth close to 10% annually, from 865,000 patients in 2015 to 1,350,000 in 2020. Procedure growth in the United States alone is projected at an 11.0% annual rate, from 250,000 in 2015 to 422,000 in 2020; accompanied by an 11.7% growth in revenues, from $1.85 billion in 2015 to $3.220 billion in 2020. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance and CE Mark for the PURE EP System. The Company has achieved proof of concept validation and tested its prototype at the University of California at Los Angeles (UCLA) Cardiac Arrhythmia Center, and has performed pre-clinical studies at Mayo Clinic in Minnesota and Mount Sinai Hospital in NY. The company continues to perform research and development studies in the form of an Advanced Research Program at Mayo Clinic which began in June 2016. Other prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute and UH Case Medical Center in Cleveland also play an important role in the PURE EP technology.


News Article | February 15, 2017
Site: www.businesswire.com

NASHVILLE, Tenn.--(BUSINESS WIRE)--Harris Research, Inc. (HRI), parent company of home service franchise brands Chem-Dry Carpet and Upholstery Cleaning and N-Hance Wood Refinishing reported that new franchise agreements signed in 2016 was the highest in the past ten years. Increased consumer spending on home services, growing popularity of healthier and more environmentally friendly services, stronger brand differentiation and smart investments in key areas of the business were significant contributors to the increased consumer demand and franchise sales. The company expects these factors to continue to drive strong results in 2017, projecting over 230 in combined franchise sales again for this year. Chem-Dry and N-Hance sold more than 230 franchise units combined in 2016 across the U.S. and Canada. N-Hance ended the year with 97 new agreements while Chem-Dry finished the year with 135 new franchise sales — marking the fifth straight year Chem-Dry sold over 100 units and helping N-Hance more than double its system size over the last four years. “Consumer spending on home improvement and repair continues to experience annual growth as home owners are seeing increased equity value in their homes and are viewing them as great investments, many times choosing to modify existing properties rather than move or build new homes,” said HRI President and CEO Dan Tarantin. “As a result, our franchisees are having success in their markets, with both N-Hance and Chem-Dry franchisees having realized substantial revenue growth, and our system is growing, having achieved record combined franchise unit sales for the past decade. The future of the home services and remodeling industry remains strong and vibrant and our goal is to continue to be the industry leader in innovation, quality of work, customer service and healthfulness.” Over the last several years, HRI has invested in additional support and key personnel for both brands to strengthen its offerings and provide new resources for franchisees, including enhanced start-up training for new owners and advanced national marketing tools to help them drive more business. HRI also continues to make significant investments in the area of research and development that has resulted in the launch of more than 20 proprietary new and improved products to its line of superior-performing solutions and leading edge equipment – the foundation for what allows franchise owners to deliver a superior customer experience. Across the two franchise brands, there are more than 4,000 technicians and customer service representatives employed by its network of independently owned and operated units. The 2016 unit sales growth for both Chem-Dry and N-Hance created an estimated 500 new jobs. Similar job growth is projected for 2017 as the HRI brands are looking to add more operators and locations in prime markets across the country, with the greatest focus being on unserved areas. “We’re recognizing and celebrating a number of important milestones in our business. In addition to achieving the record growth we saw in 2016 and welcoming large numbers of outstanding new operators to our system, Chem-Dry is celebrating its 40th anniversary this year,” said Tarantin. “This year, we also expect N-Hance to surpass the 500-unit threshold, which is very exciting for a relatively young and fast-growing brand. I think our growth and success is tied to the fact that both N-Hance and Chem-Dry offer unique, high quality products and services that fit the discerning, healthier mindset and lifestyle of today’s customers — and we see that trend continuing in 2017 and beyond, which should continue to fuel strong growth for both of our brands.” Chem-Dry uses a green-certified solution and proprietary deeper-cleaning Hot Carbonating Extraction (HCE) process to create healthier homes and workplaces. In a study by an independent lab, Chem-Dry’s HCE cleaning method was found to remove 98 percent of common household allergens from carpets and upholstery and 89 percent of airborne bacteria when a sanitizer was added. As part of the brand’s Healthy Home initiative, it now has 42 Green Certified products. N-Hance uses proprietary solutions and refinishing techniques to restore the natural beauty of your hardwood floors, cabinets, doors and trims – at a more affordable cost than traditional remodels such as re-facing or replacing cabinets. N-Hance can also change the color of your wood surfaces to provide a whole new look with a factory-quality finish that reduces bacteria growth by 99 percent. For more information on N-Hance and Chem-Dry franchise opportunities, please visit www.nhancefranchise.com and www.chemdryfranchise.com. Harris Research is a portfolio company of Baird Capital Partners. HRI is the owner of the Chem-Dry and N-Hance franchise businesses. Chem-Dry is the world’s leading carpet and upholstery cleaning service with a network of 3,000 units in over 50 countries serving over 11,000 homes and businesses a day worldwide. Its green-certified solution and proprietary Hot Carbonating Extraction cleaning process provide a deeper clean, allow surfaces to dry faster, and leave homes healthier. N-Hance Wood Refinishing is the #1 wood refinishing company in the United States, with more than 400 locations across the U.S., Canada, Australia and New Zealand. N-Hance can restore the natural beauty of your hardwood floors, cabinets, doors and trims or can change the color of your wood surfaces to provide a whole new look with a factory-quality finish. The company’s proprietary products and refinishing techniques shorten the process and decrease the mess, offering a more convenient way to refinish your wood surfaces. Founded in 2001, N-Hance Wood Refinishing is a trusted partner of the Home Depot, with a presence in more than 1,400 locations.

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