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Soligenix Receives $750,000 in Non-Dilutive Financing from New Jersey's Technology Business Tax Certificate Transfer Program
Receipt of Proceeds increases January Cash Position to Approximately $6.6 million
PR Newswire
Soligenix, Inc. 2 hours ago
PRINCETON, N.J., Jan. 16, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well a developing several biodefense vaccines and therapeutics, announced today that it has recently received approximately $750,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program (the Program).
This Program enables approved, unprofitable biotechnology businesses to sell their unused Net Operating Loss Carryovers (NOLs) and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. This allows biotechnology businesses with NOLs to turn their tax losses and credits into cash proceeds to fund more R&D, buy equipment and/or facilities, or cover other allowable expenditures. The New Jersey Economic Development Authority (NJEDA) determines eligibility for the Program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The state of New Jersey was the originator of this Program and the first state to implement and fund it.
"As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA's decision to approve our application in this year's program," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "This NOL funding is a nice addition to other non-dilutive funding we have recently been awarded from BARDA and NIAID. We are very thankful for New Jersey's continued support of its biotechnology industry."
About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.
Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
CONTACT: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200, www.soligenix.com, Soligenix, Inc.
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Vista Partners Initiates Coverage on Soligenix, Inc. (Ticker: SNGX); $5.50 Price Target
Marketwired
Vista Partners LLC March 18, 2014 9:00 AM
SAN FRANCISCO, CA--(Marketwired - Mar 18, 2014) - Vista Partners announced today that it has initiated coverage on Soligenix, Inc. (OTCBB: SNGX) with a twelve-month price target of $5.50. Soligenix, Inc. is a New Jersey based clinical stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases. Ross Silver, Principal Analyst at Vista Partners, stated, "Soligenix has signed an exclusive worldwide collaboration deal with Intrexon Corporation ($2.9B mkt cap) (NYSE: XON) to develop a novel passive immunotherapy for Melioidosis. Melioidosis, also known as Bp, is an often deadly infectious disease caused by the bacterium, Burkholderia pseudomallei, with some symptoms similar to those of the flu and pneumonia. Melioidosis occurs in many different places around the globe, currently however it is of greatest concern in southeast-Asia and northern Australia, where public officials see it as a major threat to the health of the population." Mr. Silver continues, "The Company also has an exclusive commercial collaboration with SciClone Pharmaceuticals ($250M mkt cap) (NASDAQ: SCLN) in China for SGX942 in the treatment of oral mucositis." Mr. Silver concludes, "The Company boasts a diverse pipeline with nine prospective drug candidates. The science behind the Company's prospective therapies has been and continues to be validated by a number of significant, important and influential entities such as government organizations and major pharmaceutical companies. To date the Company has been awarded approximately $40M mainly through BARDA, NIH and FDA grants/contracts. The Company has up to approximately $34 million in active government contract and grant funding still available to support its associated research programs through 2018."
To download a FREE copy of the Soligenix, Inc. research report, please visit http://www.vistapglobal.com and click the "download research" icon to gain access to the report.
About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.
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Soligenix Awarded NIAID Contract Valued up to $24.7 Million for the Development of Heat Stable RiVax™ Vaccine
PR Newswire
Soligenix, Inc. September 19, 2014 7:00 AM
PRINCETON, N.J., Sept. 19, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it has been awarded a contract valued at up to $24.7 million inclusive of options by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID). The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax™, combined with the company's ricin toxin vaccine, Rivax™, as a medical countermeasure (MCM) to prevent the effects of ricin exposure.
The contract contains a 16 month base period providing financial support of approximately $5.8 million, followed by several contract options that would extend the contract award for up to six years. If all contract options are exercised, the total award will support the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax™ with the US Food and Drug Administration (FDA).
"Securing this highly competitive NIAID contract provides further recognition as to the innovative quality and potential impact of both our vaccine and thermostabilization technologies," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With this new contract award, the Company now has up to $57 million in NIAID and BARDA funding to advance the biodefense business segment. We thank NIAID for their past and present support and look forward to collaborating closely with them as we advance RiVax™ development towards potential FDA licensure and procurement for the national stockpile."
This is Soligenix's third awarded federal contract. Soligenix's gastrointestinal acute radiation syndrome (GI ARS) program is supported by contract awards from both the Biomedical Advanced Research Development Authority (BARDA) and NIAID, totaling up to approximately $32 million to support the development of OrbeShield™ as a MCM for GI ARS.
About Ricin Toxin
Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, or pellet. Ricin can also be dissolved in water and other liquids. It is so powerful of a poison that the US Centers for Disease Control (CDC) estimate the lethal dose in humans is about the size of a grain of salt. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure and is especially toxic when inhaled. Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins. Ricin inactivates the ribosomes in cells making them unable to produce proteins needed to survive and reproduce. When ribosomes are inactivated, cells die.
There are currently no effective means to prevent the effects of ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.
About RiVax™
RiVax™ is Soligenix's proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.
RiVax™ contains a genetically altered version of RTA chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals. To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.
The development of RiVax™ has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were granted to Soligenix and to University of Texas Southwestern (UTSW) where the vaccine originated. To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $25 million in grant funding from NIAID for development of RiVax™ and related vaccine technologies. RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.
About ThermoVax™
ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain. Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities. Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges. NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency situations.
The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit). By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.
Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has demonstrated statistically significant preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Vista Partners Updates Coverage on Soligenix, Inc. (Ticker: SNGX); Revises Price Target Higher From $5.50 to $7.00
Marketwired
Vista Partners LLC September 24, 2014 9:00 AM
SAN FRANCISCO, CA--(Marketwired - Sep 24, 2014) - Vista Partners announced today that it has updated coverage on Soligenix, Inc. (OTCBB: SNGX), based in Princeton, New Jersey, and revised its twelve-month price target higher from $5.50 to $7.00. Ross Silver, Principal Analyst at Vista Partners, stated, "The Company boasts a diverse pipeline with ten prospective drug candidates, including a Phase 3 ready asset slated to enter the clinic in early 2015. The science behind the Company's prospective therapies has been and continues to be validated by a number of significant, important and influential entities such as government organizations and major pharmaceutical companies. The Company has been awarded numerous government grants and entered into strategic agreements with two companies, Intrexon (~$1.9B mkt cap.) and SciClone (~$360M mkt cap). The main financial contributor has been the U.S. government. To date, the Company has been awarded approximately $40M mainly through BARDA, NIH and FDA grants/contracts. On top of the $7.1M financing completed in 2013, the Company has up to approximately $57 million in active government contracts and grant funding still available to support its associated research programs through 2018. The Company is in the process of petitioning and filling applications for a number of additional grants for further support of its programs with various funding agencies."
To download a FREE copy of the Soligenix, Inc. research report, please visit http://www.vistapglobal.com and click the "download research" icon to gain access to the report.
About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.
Please follow us on Twitter @VistaPResearch & Facebook at Vista-Partners to receive updates, thoughts and ideas about and our coverage universe of companies and more.
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For a full list of disclaimers and disclosures, please visit our website www.vistapglobal.com or click here.
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Soligenix: A Low Risk, High Return Biotech Stock
Oct. 20, 2014 5:58 PM ET | 6 comments | About: Soligenix, Inc. (SNGX)
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.
Summary
Soligenix received FDA clearance to start a Phase III trial in Cutaneous T-Cell Lymphoma in 2015.
Its ricin vaccine recently demonstrated 100% survival after lethal exposure to ricin.
The company received $24.7 million in financing to develop its heat stable ricin vaccine.
Initiating clinical trials in Acute Radiation Enteritis (Phase II) and Pediatric Crohn's disease (Phase II/III) in early 2015.
Shares are significantly undervalued and we reiterate an outperform rating with a 12-month price target of $4.50 per share.
Soligenix (OTCQB:SNGX) is a late stage biopharmaceutical company focused on the development of therapeutics for the treatment of inflammatory diseases, cancer and biodefense applications. Their pipeline includes novel therapeutics for orphan diseases and vaccines/drugs for civilian and military biodefense purposes. The company's orphan disease program focuses on cutaneous T-cell lymphoma, pediatric Crohn's disease, oral mucositis, and acute radiation enteritis (Figure 1). Their biodefense pipeline includes vaccines for ricin and anthrax as well as drugs for gastrointestinal acute radiation syndrome and melioidosis (Figure 1).
Figure : Soligenix's clinical pipeline (www.soligenix.com/prod.shtml)
The company has recently announced several positive developments, including the acquisition of new technology, positive trial results and government contract funding exceeding $55 million. In this report, we highlight recent corporate events as we believe Soligenix is a low-risk investment with significant upside potential.
Therapeutics for Orphan and Rare Diseases
Acquisition of a Phase III Program for Cutaneous T-Cell Lymphoma (CTCL)
Soligenix acquired a novel orphan drug candidate, SGX301 (synthetic hypericin) on September 3, 2014 for the treatment of CTCL. SGX301, a Phase III drug candidate, was purchased from Hy Biopharma for up to $14 million dependent on successful achievement of certain development milestones. This purchase is predominantly (98%) in the form of restricted stock payments. CTCL is a type of non-Hodgkin's lymphoma (NHL) caused by a T-cell mutation in which there are no currently approved front-line treatments. It is estimated that CTCL affects over 20,000 individuals in the US with median survival of only 2.5 years in advanced disease.
SGX301, when combined with a safe light (fluorescent) source, can treat early-stage CTCL skin lesions. The photodynamic therapy allows for targeted application to skin lesions leaving adjacent normal tissues unaffected. Phase I and Phase II studies using SGX301 found the drug to be safe and well tolerated. In a Phase II, placebo-controlled study in patients with CTCL, the therapy yielded a response rate of 58.3% in CTCL patients compared to 8.3% in patients receiving placebo (p < 0.04, Figure 2). SGX301 has received orphan drug designation from the FDA for the treatment of CTCL.
Figure : www.soligenix.com/prod_reference_literat...
Based on these data, the company announced on September 17, 2014 that the FDA had agreed on a trial design to begin its pivotal Phase III clinical trial in the first half of 2015. The study will be a double-blind, randomized and placebo-controlled with the primary endpoint of evaluating CAILS (Composite Assessment of Index Lesion Severity) on the three worst CTCL lesions. The company expects top line data will be available in the second half of 2016. We estimate SGX301 could be approved by the FDA in 2017 if data from the Phase III trial are positive.
In addition to CTCL, SGX301 may also be used for other indications such as psoriasis. Psoriasis afflicts over 7 million people a year in the United States alone, thus this indication could further expand the company's pipeline. Other forms of photodynamic therapy are frequently used for the initial treatment of psoriasis; however, these therapies pose an increased risk of melanoma and non-melanoma skin cancers. SGX301 could provide a safe and more effective treatment for these patients. We believe that the acquisition of this late-stage candidate is a de-risking event for the company.
Grant Award to Support a Phase II Clinical Trial for Oral Mucositis
In December 2013, Soligenix initiated a Phase II clinical trial using its drug candidate, SGX942, for the treatment of oral mucositis in patients with cancer of the mouth and oropharynx. SGX942 is a novel synthetic peptide that has been shown to reduce tissue damage as a result of chemotherapy and/or radiotherapy in vivo. Patients often experience debilitating oral mucositis as a result of the adverse side effects of treatment with radiation and chemotherapy. In April 2014, the National Institute of Dental and Craniofacial Research awarded Soligenix a Small Business Innovation Research (SBIR) grant to further support the trial evaluating SGX942.
The primary endpoint of this trial will be assessed on the basis of incidence and duration of oral mucositis throughout the course of radiation treatment. Secondary endpoints will assess patient reported outcomes and pharmacoeconomic parameters such as hospitalization and radiation-associated side effects, including mouth stiffness (trismus) and dryness (xerostomia). The company conducted a Phase I clinical trial of SGX942 which showed the drug to be safe and well tolerated in 84 healthy volunteers. Results from the Phase II trial are expected in the first half of 2015.
Vaccines for Biodefense Applications
$24.7 Million Award for Heat Stable Ricin Vaccine from the National Institute of Allergy and Infectious Diseases (NIAID)
Soligenix's ricin vaccine development program has received two positive developments in the recent months. Currently, no approved vaccines exist to combat the detrimental effects of ricin poisoning. The company is developing a heat stable version of its ricin vaccine called RiVax, which enables stock piling of the vaccine to be deployed in the event of a terrorist act. In September, positive results of a preclinical study in non-human primates resulted in complete protection from exposure of 3-5 times the known lethal dose of ricin. The study yielded statistically significant survival data (p < 0.002) with treated primates exhibiting neutralizing antibodies in the blood. Typically, animals succumb to the ricin toxin within 36 hours of exposure and develop severe lung damage. These data represent a significant leap forward in establishing efficacy under the FDA's "animal rule". Under this rule, vaccines cannot be tested in humans unless safety and efficacy are first established in non-human primates.
Subsequently, the company received a government contract for up to $24.7 million from the NIAID to develop the product for counter terrorism measures. If subsequent studies are successful, RiVax could be added to the US Strategic National Stockpile and potentially dispensed if ricin is used as a biological weapon in a terrorist attack. The positive primate data and the large financial award from the NIAID help validate the technology. The company plans to execute human safety and immunogenicity trials along with advancing the manufacturing and scale up of RiVax.
Rapidly Acting Heat Stable Anthrax Vaccine
In addition to ricin, Soligenix is also developing a heat stable anthrax vaccine. The vaccine called VeloThrax combines a toll-like receptor 4 (TLR4) agonist as a secondary adjuvant in order to activate the immune system to help the body recognize foreign pathogens. Using a TLR4 agonist, the company believes that the body will be able to more quickly become protected after vaccine administration. In August, the company showed that animal models using the vaccine suggest complete immunity against anthrax can be achieved after only two administrations of the vaccine. This observation is quite compelling, as current vaccines without the TLR4 adjuvant require up to five vaccinations over 18 months in order to become protected against the pathogen. The vaccine is also stable at high temperatures for a least three months meaning that it was capable of inducing antibodies against anthrax for extended durations of time. We believe VeloThrax provides a distinct advantage over other anthrax vaccines by requiring fewer vaccinations as well as being stable at high temperatures for long periods. The company plans to develop VeloThrax under the support of government grants and contracts. If development is successful, there is the potential for the company to be awarded significant procurement contracts from the government, which could exceed $500 million.
Combination of RiVax and VeloThrax for Protection against Ricin and Anthrax
Soligenix is also testing the combination of both RiVax and VeloThrax to be administered as a single vaccine. Preclinical data thus far has shown that both vaccines administered in a single dose can induce antibodies against both pathogens. Furthermore, these antibodies were present 200 days after immunization after only two vaccinations. These studies were sponsored under a $9.4 million cooperative grant from the NIAID. Results suggest that long-term immunity upon simultaneous vaccination can be achieved. This is important because both vaccines are developed for military usage and emergency first responders.
Soligenix is Expanding its Clinical Pipeline
Pediatric Children's Crohn's Disease
The company is currently developing SGX203, an anti-inflammatory agent, for the treatment of pediatric Crohn's disease. Currently, there is no viable first-line treatment for pediatric Crohn's disease and current therapies such as Remicade carry a black box warning about its potential to induce malignancies. SGX203 is designed to block resultant inflammation caused by Crohn's disease in the GI tract. In a Phase I study completed in May 2013, pharmacokinetic (PK) profiling established a safe and well tolerated dosing regimen. Soligenix plans to initiate a Phase II/III trial of SGX203 for the treatment of pediatric Crohn's disease in the first half of 2015 with primary endpoint data expected in the second half of 2016. The drug has received both Fast Track and Orphan Drug designations from the FDA and we believe SGX203 has the potential to meet an important medical need in children with this serious illness.
Prevention of Acute Radiation Enteritis
In the US, more than 100,000 patients per year are subject to radiation for the treatment of cancer and many of these patients develop acute radiation enteritis. The disease results in inflammation of the lining of the bowels and patients are burdened by vomiting, abdominal pain, bleeding and can require additional hospitalization. Soligenix is developing SGX201, an orally formulated anti-inflammatory drug, designed to block inflammation in the GI tract in patients receiving radiotherapy for the treatment of lower GI cancers. The company has completed a Phase I/II trial and determined the drug was safe and well tolerated. This Fast Track designated drug is poised to enter a Phase II trial in 2015, contingent upon continued government funding, with primary endpoint data expected in the second half of 2016. There are no approved therapies for this indication, thus a positive trial using SGX201 will open up yet another market for Soligenix.
Strategic Cash Management Combined with Non-dilutive Financing
The company is well funded as it signed a stock purchase agreement with Lincoln Park Capital Fund in November 2013 allowing for the availability of periodic investments of up to $10 million over 36 months through the sale of its common stock. As of the end of June 2014, the company had approximately $5.0 million in cash on hand and management has remained aggressive in the pursuit of government grants and contracts across its pipeline. It has already secured more than $55 million in grants and contracts, as these are great non-dilutive financing to support its pipeline. Thus, Soligenix can focus on advancing its clinical programs and its robust pipeline (Figure 3) without the fear of any near term dilution.
(click to enlarge)
Figure : www.soligenix.com/prod_reference_literat...
In addition to the funding already previously mentioned, Soligenix was recently awarded an additional $2.1 million in August to advance the preclinical development of OrbeShield. OrbeShield is a drug that is designed to protect against the exposure to ionizing radiation after a natural disaster. The total contract award is valued at up to $6.4 million over three years. This program is being supported by awards from the Biomedical Advanced Research Development Authority and NIAID for up to $32 million.
Soligenix Shares Are Significantly Undervalued
Soligenix has developed a diversified drug pipeline in therapeutics, biodefense vaccines and vaccine heat stabilization technology. Results for SGX942 in Oral Mucositis should be available in the first half of 2015. Positive data from this Phase II study will validate the company's platform and significantly de-risk its technology as the market for this disease is quite large. This drug also has many other potential targets in infectious diseases and GI disorders thus further expanding the company's potential market share.
Additionally, Soligenix's vaccines and biodefense program have the potential to provide significant value to the company. If approved by the FDA, the company will most likely establish contracts to stockpile its vaccines with US and foreign governments. Traditionally, stockpile or procurement contracts have been very lucrative from the government. Since their vaccines fill a major unmet need for protection against potential bioterrorism events, they should provide significant cash flow to the company.
Currently, shares of Soligenix are trading at around $1.75 per share, which values the company at a $38 million market cap. At current levels, we believe shares are significantly undervalued. Thus, we maintain an outperform rating and a 12-month price target of $4.50 per share. Similar biotechnology companies at this development stage are valued between $50 million to $1 billion. Soligenix is a late stage company with multiple Phase II and III programs and two more programs moving into Phase II/III in 2015. There will be multiple catalysts (Figure 3) in the next 6 to 18 months with the vaccine program unprecedented compared to its peers; therefore, this company may be a low risk, high reward opportunity.
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Soligenix Reports Third Quarter 2014 Financial Results, Highlighted with the Acquisition of SGX301, Synthetic Hypericin, for the Treatment of Cutaneous T-Cell Lymphoma
PR Newswire
Soligenix, Inc. November 10, 2014 7:00 AM
PRINCETON, N.J., Nov. 10, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today its financial results for the third quarter and nine months ended September 30, 2014.
Soligenix's revenues for the quarter and nine months ended September 30, 2014 were $2.8 million as compared to $0.3 million for the quarter and $5.1 million as compared to $1.8 million for the nine months ended September 30, 2014 and 2013, respectively. For the nine months ended September 30, 2014 as compared to September 30, 2013, revenues increased $3.3 million primarily related to contracts with the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) in support of OrbeShield™ (oral beclomethasone 17,21-dipropionate or BDP) development in the treatment of gastrointestinal acute radiation syndrome (GI ARS).
Soligenix's net (loss) for the quarter ended September 30, 2014 was $4.3 million, or $(0.21) per share, as compared to $6.6 million, or $(0.34) per share and $8.6 million, or $(0.43) per share as compared to $11.1 million, or $(0.78) for the nine months ended September 30, 2014.
Research and development expenses were $5.1 million as compared to $1.2 million and $7.3 million as compared to $4.1 million for the quarter and nine months ended September 30, 2014 and 2013, respectively. For the quarter ended September 30, 2014, the increase of $3.9 million is attributable to the acquisition of SGX301, synthetic hypericin, from Hy BioPharma paid in the form of $0.25 million in cash and $3.75 million in restricted common stock. For the nine months ended September 30, 2014, the increase of $3.2 million is attributable to the acquisition of SGX301 offset by a $1.5 million non-cash charge which was included in the 2013 nine months expenses relating to our collaboration with Intrexon Corporation (Intrexon).
General and administrative expenses were $0.7 million as compared to $0.7 million and $2.4 million as compared to $1.9 million for the quarter and nine months ended September 30, 2014 and 2013, respectively.
Operating expenses increased by $3.9 million and $3.7 million for the quarter and nine months ended September 30, 2014, respectively. The increase in operating expenses for the quarter ended September 30, 2014 is primarily related to the acquisition of SGX301, synthetic hypericin, and for nine months ended September 30, 2014 primarily related to the acquisition of SGX301, synthetic hypericin, offset by a $1.5 million non-cash charge in 2013 nine months expenses related to our collaboration with Intrexon.
For the three and nine months ended September 30, 2014, other net income/(expense) included a $0.8 million and $(0.2) million change in fair value of the warrant liability related to warrants issued in connection with the Company's June 2013 registered public offering.
As of September 30, 2014, the Company's cash position was $4.2 million.
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During this quarter we made significant progress in both our business segments. In our BioTherapeutics segment we expanded our pipeline with the acquisition of SGX301, synthetic hypericin, with plans to initiate a pivotal Phase 3 clinical trial in the first half of 2015. We are also continuing to actively enroll patients in our Phase 2 study with SGX942 in the treatment of oral mucositis in head and neck cancer. In our Vaccine/BioDefense segment, our RiVax™ program utilizing our ThermoVax™ platform was further validated with the award of a multi-year NIAID contract valued up to $24.7 million. This contract award coupled with our contracts awarded for OrbeShield™ in GI ARS of up to $32.7 provides up to $57 million in non dilutive program funding. As we further expanded our development pipeline, while continuing to advance our current clinical programs, we continue to effectively manage cash burn ending the quarter with $4.2 million in cash. I look forward to providing updates for the balance of 2014 and throughout 2015."
Soligenix Recent Highlights:
On September 23, 2014, the Company announced that it had appointed Rasappa Arumugham, PhD, as its Vice President of Biopharmaceutical Development. Dr. Arumugham has over 25 years of diverse experience in biopharmaceutical research and development (R&D) in the areas of formulation research, analytical method development, quality control (QC), and manufacturing. He has a proven track record in development, scale-up, and technology transfer supporting commercialization of vaccines and biologics, including Prevnar®, Tetramune™, HibTITER®, Meningitec® Conjugate and meningitis B (bivalent rLP2086) Lipoprotein Subunit Vaccines.
On September 19, 2014, the Company announced that it was awarded a contract valued at up to $24.7 million inclusive of options by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID). The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax™, combined with the company's ricin toxin vaccine, Rivax™, as a medical countermeasure to prevent the effects of ricin exposure.
On September 17, 2014, the Company announced that an agreement had been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).
On September 9, 2014, the Company announced that the US Patent and Trademark Office (US PTO) granted patent 8,808,710 entitled "Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition." The newly issued patent claims cover compositions and methods for manufacturing vaccines utilizing ThermoVax™, the Company's proprietary vaccine thermostabilization technology. The new patent complements US patent 8,444,991, granted on May 21, 2013, that primarily included claims for methods of making stabilized vaccines.
On September 5, 2014, the Company announced the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin). SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of CTCL and is highly synergistic with the company's existing development pipeline. As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data. SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light.
On September 2, 2014, the Company announced promising preliminary results from a preclinical study with its ricin toxin vaccine RiVax™, in a non-human primate (NHP) lethal aerosol exposure model. The study demonstrated that NHPs vaccinated with RiVax™ were completely protected against a lethal aerosol of ricin toxin with a highly significant survival benefit (p
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.
Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has demonstrated statistically significant preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™. Recently, Soligenix was awarded a NIAID contract valued up to $24.7 million to further advance the development of its heat stable RiVax™ as a medical countermeasure to prevent the effects of ricin exposure. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Soligenix Announces Formation of Cutaneous T-Cell Lymphoma Medical Advisory Board
PR Newswire
Soligenix, Inc. November 17, 2014 7:15 AM
PRINCETON, N.J., Nov. 17, 2014 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare class of non-Hodgkin's lymphoma (NHL).
Comprised of dermatologic oncology thought leaders with extensive experience in CTCL, the MAB will play an important advisory role in the conduct of the upcoming Phase 3, pivotal clinical study as well as in the design of subsequent clinical studies (in other indications, e.g., psoriasis) and associated regulatory interactions with health authorities. The MAB will provide feedback, input and guidance on clinical strategies and their implementation as well as on other critical issues, such as health economics and reimbursement to assist Soligenix in meeting the needs of the CTCL patient population.
"I enthusiastically support Soligenix in their efforts to improve outcomes for patients with CTCL, affecting up to 50,000 patients in the US," stated Alain Rook, MD, Director, Cutaneous Lymphoma Program, Perelman School of Medicine of the University of Pennsylvania. "I have had a lengthy scientific and clinical interest in hypericin and am pleased that the Soligenix team is advancing this product. I believe that SGX301 has the potential to be a major step forward in the treatment of CTCL by providing a safer alternative therapy in comparison to other forms of phototherapy over the course of the patients' disease than is currently available. I look forward to working with my esteemed colleagues to support Soligenix in advancing this important development program forward."
"We are pleased to be able to attract such esteemed and enthusiastic professionals to participate as members of our Medical Advisory Board," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The initiation of a CTCL program marks the first step in the development of our newly acquired SGX301 program. We look forward to working with the MAB and initiating the pivotal clinical trial in 2015."
The MAB Members
Alain Rook, MD
Dr. Rook is a Professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania and is the Director of the CTCL and Extracorporeal Photopheresis Program. He has conducted seminal studies on the photodynamic therapeutic efficacy of synthetic hypericin in CTCL and psoriasis patients and on its apoptotic activity in malignant cancer cells. Dr. Rook's research has been supported by the Leukemia and Lymphoma Society, the National Institutes of Health and National Cancer Institute. He graduated from the University of Michigan with an MD degree. Dr. Rook is Board Certified in Dermatology, Internal Medicine, and Nephrology.
Youn Kim, MD
Dr. Kim is the Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma at Stanford University. She is an international renowned expert in cutaneous lymphomas and is the director of the Multi-disciplinary Cutaneous Lymphoma Program and Medical Director of the photopheresis Unit at Stanford Medical Center and is Co-Director of the Lymphoma Research Program at the Stanford Cancer Institute. She graduated from Stanford University School of Medicine with an MD degree. Dr. Kim is Board Certified in Dermatology.
Gary Wood, MD
Dr. Wood is the Chair and Professor of Dermatology at the University of Wisconsin. He is an internationally recognized expert in cutaneous lymphomas. Dr. Wood has served as President of the International Society for Cutaneous Lymphomas. He has authored more than 350 articles, chapters and abstracts, mostly focused on cutaneous oncology. He also directs the Immunodiagnosis Lab that offers comprehensive diagnostic testing for skin diseases. Dr Wood graduated from the University of Illinois at Chicago with an MD degree. Dr. Wood is triple board certified in dermatology, dermatopathology and anatomic pathology.
Madeleine Duvic, MD
Dr. Duvic is a Professor of Internal Medicine and Dermatology, and serves as the Deputy Chairman of the Department of Dermatology at The University of Texas, MD Anderson Cancer Center. She is a founding member of the US Cutaneous Lymphoma Consortium, former board member of the American Academy of Dermatology and recent vice president of the Society for Investigative Dermatology. She has been Principal Investigator of numerous clinical trials and translational research studies of T-cell mediated diseases and malignancies, especially CTCL. With over 400 scientific publications, her work is focused on developing and improving therapy for CTCL. Dr. Duvic graduated from Duke University Medical School with a MD degree and completed an internship and residencies in internal medicine and dermatology, served as chief resident, and completed fellowships in molecular biology and geriatrics. Dr. Duvic is Board Certified in Internal Medicine and Dermatology and heads the CTCL multi-disciplinary clinic at MD Anderson Cancer Center.
About CTCL
Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug designation from the US Food and Drug Administration.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs is supported by our heat stabilization technology, known as ThermoVax™, under existing and on-going government contract funding.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Soligenix Announces Presentation and Poster at the 2015 ASM Biodefense and Emerging Diseases Research Meeting in Washington, DC
Published: Feb 2, 2015 7:00 a.m. ET
PRINCETON, N.J., Feb. 2, 2015 /PRNewswire/ -- Soligenix, Inc. (otcqb:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it will be presenting preclinical data from two biodefense programs at the upcoming American Society of Microbiology (ASM) Biodefense and Emerging Diseases Research Meeting on February 9-11, 2015 to be held at the Washington Marriott Wardman Park, 2660 Woodley Rd. NW.
The presented results will address recent preclinical efficacy findings with SGX943 in the treatment of melioidosis and with RiVaxÔ, a proprietary thermostable ricin toxin vaccine, in an inhalational model of ricin intoxication. SGX943 is based on Soligenix's SGX94 technology, an Innate Defense Regulator which enhances the anti-infective activity of the innate immune system while modulating inflammation. Since SGX943 does not directly target the bacteria, it is unlikely to engender resistance and is complementary with current antibiotic regimens. RiVax™ is the Company's candidate vaccine for the prevention of exposure to ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin. When formulated with Soligenix's proprietary ThermoVax™ technology, RiVax™ has demonstrated significantly enhanced thermostability, enabling storage without cold chain requirements.
Preclinical studies for both SGX943 and RiVax™ were supported by grant awards from the National Institute of Allergy and Infectious Diseases (NIAID).
Oral Presentation:
Innate Defense Regulators as a Treatment for Melioidosis presented by Dr. Oreola Donini, Chief Scientific Officer, Soligenix, Inc., on February 10, 2015 from 5:45-6:00 PM EST. The abstract is available at:
http://www.abstractsonline.com/Plan/...f-5fd3-4ea2-bbe7-ca4cd9aa0577.
Poster Presentation:
Thermostable Subunit Vaccine Results in Protective Immunity in Rhesus Macaques in an Inhalational Ricin Model attended by Dr. Oreola Donini, Chief Scientific Officer, Soligenix, Inc., on February 11, 2015 from 3:45-5:15 PM EST. The abstract is available at: http://www.abstractsonline.com/Plan/...6f-5fd3-4ea2-bbe7-ca4cd9aa0577
About ASM Biodefense and Emerging Diseases Research Meeting
The ASM Biodefense and Emerging Diseases Research Meeting is a forum for discussion between individuals conducting research to defend against bioterrorism and decision makers funding and shaping the future research agenda. Emerging infectious diseases serve as a framework for understanding the public threat of bioterrorism.
For more information about the 2015 ASM Biodefense and Emerging Diseases Research meeting, please refer to the conference website at http://asmbiodefense.org/index.php/meeting/2015-biodefense-meeting.
About Melioidosis
Melioidosis is a potentially fatal infection caused by the Gram-negative bacillus, Burkholderia pseudomallei (Bps). Highly resistant to many antibiotics, Bps can cause an acute disease characterized by a fulminant pneumonia and a chronic condition that can recrudesce. There is no preventive vaccine or effective immunotherapy for melioidosis. Therefore, there is a significant medical need for improved prevention and therapy.
Bps and the closely-related Burkholderia mallei (Bm) are considered possible biological warfare agents by the Department of Health and Human Services (DHHS) because of the potential for widespread dissemination through aerosol. Bps is classified as a Tier 1 biothreat and a category B priority pathogen by the NIAID and is a top 5 priority in the most recent Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategy document.
Bps infection (melioidosis) is a major public health concern in the endemic regions of Southeast Asia and Northern Australia. Moreover, the organism has a worldwide distribution and the full extent of global spread is likely underestimated. Bps activity is seen in Southeast Asia, South America, Africa, the Middle East, India, and Northern Australia. The highest pockets of disease activity occur in Northern Australia and Northeast Thailand, Burma and Vietnam, and is likely under-reported in China. In Northeast Thailand, the mortality rate associated with Bps infection is over 40%, making it the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.
About SGX943
SGX943 is the drug product designation for the active ingredient SGX94 in the treatment of melioidosis. SGX94 is an IDR, a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation-therapy. SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX94 and related analogs have a strong intellectual property position, including composition of matter. SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development to date, inclusive of government grants. SGX94, the active ingredient in SGX942, is also in clinical development for the treatment of oral mucositis.
The testing of SGX943 in melioidosis is currently being supported by a NIAID Small Business Innovation Research (SBIR) grant valued at approximately $300,000 over one year.
About Ricin Toxin
Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, pill, or pellet. Ricin can also be dissolved in water and other liquids. As a poison, ricin is so potent that the US Centers for Disease Control (CDC) estimates the lethal dose in humans is about the size of a grain of salt. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure, and is especially toxic when inhaled. Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins. The enzymatic ricin toxin A subunit (RTA) is an RNA-N-glycosidase which cleaves a specific adenine residue with eukaryotic 28S ribosomal RNA, leading to protein synthesis arrest and cell death.
There are currently no effective means to prevent the effects of ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.
About RiVax™
RiVax™ is Soligenix's proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.
RiVax™ contains a genetically altered version of RTA chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals. To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.
The development of RiVax™ has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were awarded to Soligenix and to University of Texas Southwestern (UTSW) where the vaccine originated. To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $25 million in grant funding from the US government for development of RiVax™ and related vaccine technologies. RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack. RiVax™ is currently the subject of a contract valued at up to $24.7 million inclusive of options over a period of 6 years and awarded by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by NIAID).
About ThermoVax™
ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain. Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities. Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges. NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.
The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit). By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +2.68% focused on the joint development of SGX101 for the treatment for melioidosis.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/...shington-dc-300028851.html
SOURCE Soligenix, Inc.
Copyright (C) 2015 PR Newswire. All rights reserved
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Vista Partners Updates Coverage on Soligenix, Inc. (Ticker: SNGX); Price Target $7.00
Marketwired
Vista Partners LLC 3 hours ago
Vista Partners Updates Coverage on Soligenix, Inc. (Ticker: SNGX); Price Target $7.00
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SAN FRANCISCO, CA--(Marketwired - Feb 12, 2015) - Vista Partners announced today that it has updated coverage on Soligenix, Inc. ("The Company" or "SNGX") (OTCQB: SNGX), a clinical stage biopharmaceutical company based in Princeton, New Jersey, and maintains its twelve-month price target of $7.00. Ross Silver, Principal Analyst at Vista Partners, stated, "The Company boasts a diverse pipeline with ten prospective drug candidates, including a Phase 3 ready asset slated to enter the clinic in early 2015 and Phase 2 data due on SGX942, the Company's clinical candidate for the treatment of Oral Mucositis, due by the end of June 2015. Mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy." Mr. Silver goes on to state, "The science behind the Company's prospective therapies has been and continues to be validated by a number of significant, important and influential entities such as government organizations and major pharmaceutical companies. The Company has been awarded numerous government grants and entered into strategic agreements with two companies Intrexon (~$3.5B mkt cap.) and SciClone (~$390M mkt cap)." Mr. Silver concludes, "The Company has up to approximately $57 million in active government contracts and grant funding still available to support its associated research programs through 2018."
To download a FREE copy of the Soligenix, Inc. research report, please visit http://www.vistapglobal.com and click the "download research" icon to gain access to the report.
About Vista Partners:
Vista Partners LLC, founded in 2005, is a Registered Investment Advisor in the States of California and Oregon. The firm's professional staff has backgrounds in finance, corporate communications and investment banking. Vista focuses on investing globally across all market sectors. Vista also provides investment considerations on publicly traded companies through a platform of stock research reports, newsletters, company specific webpages and daily commentary. The platform of products is meant to serve as potential tools for investors to learn about investment considerations. It is Vista's mission to provide investors with tools that may enable them to make profitable investment decisions with the goal to deliver investment considerations that outperform small, mid and large cap equity indexes.
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