Soligenix Reports First Quarter 2012 Financial Results and Highlights Recent Accomplishments (SNGX)

Soligenix, Inc. (SNGX.OB) is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing oral BDP for the prevention/treatment of other gastrointestinal disorders characterized by severe inflammation, including acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial and pediatric Crohn's disease (SGX203).

The Company has announced its financial results for the quarter ending March 31, 2012. 

For the quarter ending March 31, 2012, Soligenix's revenues were $647,418, as compared to $808,005 for the first quarter of 2011. The decrease in revenues was "related to a reduction in reimbursable costs from the Company's Orphan Drug Grant covering a portion of its confirmatory Phase 3 clinical trial of orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD)."

For the quarter ending March 31, 2012, Soligenix's net loss was $1,438,755, or $(0.13) per share, as compared to $1,720,411, or $(0.16) per share for the quarter ending March 31, 2011. This represents a decreased loss of $281,656, which is primarily attributable to reduced spending due to "the stoppage of the Phase 3 clinical trial of orBec® in acute GI GVHD.  This study was stopped in September 2011 and the Company has continued to incur minor costs associated with the close out of the clinical sites, data collection and analysis."

Research and development expenses for the quarter ending March 31, 2012 were $876,794 as compared to $1,372,804 for the quarter ending March 31, 2011. This decrease is primarily attributable to reduced spending in connection with the Phase 3 clinical trial of orBec®. General and administrative expenses for the quarter ending March 31, 2012 were $655,043, compared to $604,010 for the quarter ending March 31, 2011.

As of March 31, 2012, the Company's cash position was approximately $5,320,000 with working capital of approximately $4,440,000.   

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated,

"In the first quarter of 2012 we saw meaningful progress in our Vaccine/BioDefense business segment particularly with our novel vaccine thermostabilization technology, ThermoVax™. We also continue to progress with development efforts of our oral BDP program for pediatric Crohn's disease and plan to initiate a Phase 2A clinical trial this year. We remain committed to enhancing our product development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress this year regarding our Vaccine/BioDefense programs."

Read more at Yahoo Finance. 

Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability ($SNGX)

Soligenix, Inc. (OTCBB: SNGX) is a development stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestional diseases, and vaccines for certain bioterrorism agents.  Soligenix has two areas of focus: 1) a therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as pediatric Crohn’s disease, acute radiation enteritis, and Graft-versus-Host disease (GVHD), and 2) a vaccine/biodefense segment to develop vaccines and therapeutics for military and civilian applications.

Soligenix announced further progress in the development of ThermoVax™.  ThermoVax™is a vaccine thermostabilization technology that could prove effective in keeping vaccines viable during extreme temperatures.  Prototype vaccines kept at elevated temperatures for more than three months have demonstrated stability and effectiveness after exposure to environmental stress conditions.

Robert N. Brey, PhD, Chief Scientific Officer of Soligenix, commented,

"We continue to be pleased with the data generated thus far with ThermoVax™.  The ability of vaccines to withstand extreme temperatures is a significant step forward in vaccine technology. ThermoVax™ may also enable preparation of otherwise difficult multivalent (protective against multiple pathogens) formulations. We plan to apply ThermoVax™ to other conventional vaccines that require refrigeration."

Read the full article here.  

Soligenix ($SNGX): Announces further progress with ThermoVax

Soligenix announced that progress has been based on additional characterization of the stability of prototype vaccines that have been kept at elevated temperatures in excess of three months.

• Prior results have indicated that the company's aluminum-adjuvanted ricin toxin vaccine, known as RiVax, retained effectiveness and potency while stored at 40 degrees Celsius for one month when combined with the ThermoVax technology.
• Confirmatory results have now extended these initial observations to more than three months when the vaccine is kept at 40 degrees Celsius. In contrast, liquid RiVax vaccine when stored at 40 degrees Celsius rapidly degraded and no longer maintained its effectiveness.

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Soligenix Inc. releases corporate presentation ($SNGX)

Soligenix Inc. (SNGX) is a development stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestional diseases, and vaccines for certain bioterrorism agents.  Soligenix has two areas of focus:

1. Therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as pediatric Crohn’s disease, acute radiation enteritis, and Graft-versus-Host disease (GVHD), and
2. A vaccine/biodefense segment to develop vaccines and therapeutics for military and civilian applications.

The Company has released an updated corporate presentation, current as of April 2012. The presentation includes information about the company’s value proposition, senior management team, indepedent board directors, pipeline, market potential, past and future milestones, and more.

Below is the value proposition: 

Corporate

• Diversified portfolio: BioTherapeutics and Vaccines/BioDefense
• Multiple programs in rare disease and areas of unmet medical need
• Significant NIH/FDA grant support for most programs
• Experienced management and board of directors
• End of first quarter 2012 cash approximately $6 million
• Clean capital structure with no debt or preferred stock outstanding
• Largest shareholder Sigma-Tau; approximately 26% ownership

BioTherapeutics 

• Oral BDP application for inflammatory gastrointestinal (GI) indications – acute radiation enteritis and pediatric Crohn’s Disease; markets in excess of $500 million worldwide 
• 35% royalty generating partnership with Sigma-Tau on orBec®/oral BDP for North America and Europe

Vaccines/BioDefense

• ThermoVaxTM heat stabilization technology capable of eliminating cold chain distribution and storage concerns
• Grant funded and revenue generating – $9.4 million NIH grant award
• 3 novel BioDefense development candidates
• RiVaxTM – a world leader in ricin toxin vaccine research 
• SGX202 (oral BDP) – compelling pre-clinical results in GI acute radiation syndrome (ARS)
• SGX204 – novel hyperimmunogenic anthrax vaccine from Harvard

View the full presentation below.  

Soligenix Porporate Presentation_April, 1 2012

View more presentations from DailyDoseEquities

Soligenix Announces Positive Survival Results of SGX202 in Radiation Injury; $SNGXD

Soligenix, Inc. (OTCBB: SNGXD) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of allogeneic hematopoietic cell transplantation.

The company announced additional promising preliminary results from "its continuing preclinical study of SGX202 (oral beclomethasone dipropionate or BDP) in a canine gastrointestinal acute radiation syndrome (GI ARS) model." These new study results indicate that dogs treated with SGX202 beginning "24 hours after exposure to lethal doses of total body irradiation (TBI) demonstrated statistically significant (p=0.04) improvement in survival when compared to control dogs. This study builds upon the previous results which showed statistically significant survival in dogs when dosing of SGX202 was initiated two hours after lethal doses of TBI."

George Georges, MD, Associate Member of the Clinical Research Division at Fred Hutchinson Cancer Research Center and Principal Investigator for the study, commented,

"These 24 hour post-exposure results confirm earlier findings and suggest that SGX202 may significantly improve survival from GI ARS. SGX202 may potentially inhibit the cellular and innate immune mechanisms within the gut mucosa that exaggerate mucosal damage, and improve GI recovery after radiation. In the challenging area of radiation injury, the second study also met its primary objective in protecting dogs from GI ARS and extending their survival. We are completing our analysis of the data so that we may extend our investigations of SGX202 in GI recovery after radiation exposure and build upon these promising results."

Christopher J. Schaber, PhD, Chief Executive Officer of Soligenix, added,

"We are very pleased with the results to date with SGX202 in GI ARS. Based on these data and our positive preliminary interactions with both the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), it is our intent to continue to seek additional funding for the continued development of SGX202."

The study was supported by a $1 million grant from the NIAID.

Read the full article at Drugs.com. 

Osiris (OSIR): Look's Like Sanofi (acquired Genzyme) is saying No to Prochymal

News is swirling on Osiris Therapeutics (NASDAQ: OSIR) that Sanofi (SNA) in the post Genzyme (GENZ) acquisition will discontinue Prochymal for GvHD. Prochymal is a mesenchymal cell (MSC) that is allogeneic. Similar to what Athersys (ATHX) is developing with multi-stem. Osiris has struggled with GvHD and even Biodefense company Soligenix (SNGX), just reverse split 20:1, saw Orbec, a locally acting steroid that had every indication of success fail when the pivotal trial was halted for futility. In Biotech land we often say that the "graveyard is full of companies who tried to develop xxx for yyy indication", in this case its GvHD.

We would advise investors to try to understand the following when evaluating a new cell therapy:

What is it? What we mean is "what is the active ingredient". An allogeneic MSC means a lot of things, it’s a heterogeneous cell population, and as such, just not that well defined, so from a starting point, other than saying there is a paracrine effect where the cells act like cellular Advil, it’s a tough climb to say, what is it ?

Next - What does it do exactly ? or What is the Biological Mechanism of Action (MOA) and as such, what is the clinical effect that will be measured in the trial ? How closely related are they ? Again, these are critical elements that the FDA will look for beyond, I squirt it in, and it works. Don't forget dose, homing, and integration.

Thus far developers of cell therapy seem to be struggling with these questions with a few exceptions. Baxter (BAX) and NeoStem (NBS) stand out, with a highly defined cell product (CD34+/CXCR4) cells for Preservation of Heart function. Islet BioSciences stands out with their porcine islet cells (pig) for diabetes.

Daily Dose Conclusion: OSIR has approx. $50 mln in cash as of Sept. 2011 against a $160 mln market cap. Prochymal is still being developed for a number of other indications from Crohn's disease, Type 1 diabetes and Cardiovascular indications. With that said, we need to do more analysis to understand the probabilities of success in these areas given the questions (what is it, MOA, clinical effect) that we raise above.