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

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NeoStem Closes Public Offering for $6,800,000 in Gross Proceeds ($NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.  The acquisition of PCT gives NeoStem not only access to a world class contract manufacturing cell therapy company but provides a platform and expertise around the evaluation, development and regulatory requirements to develop autologous, allogeneic, immunomodulatory and vaccine-based therapeutics. NeoStem also holds the worldwide exclusive license to VSEL(TM) Technology, which uses very small embryonic-like stem cells, shown to have several physical characteristics that are generally found in embryonic stem cells, and is pursuing the licensing of other technologies for therapeutic use.

The Company has announced "the closing of its previously announced underwritten public offering of 15,000,000 units and the exercise of the over-allotment option by the underwriter for an additional 2,000,000 units, bringing the total units offered to 17,000,000. The offering was priced at $0.40 per unit. Each unit consists of one share of common stock and a warrant to purchase one share of common stock with a per share exercise price of $0.51. Maxim Group LLC acted as sole book-running manager."

Dr. Robin Smith, NeoStem's Chairman & CEO, commented, 

"NeoStem's management remains focused on our key objectives of expanding our stem cell therapeutic contract manufacturing business, enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack and monetizing our China pharmaceutical subsidiary through divestiture."

The offering resulted in gross proceeds of $6,800,000, "prior to deducting underwriting discounts and commissions and offering expenses payable by the Company. These funds will be used for working capital purposes, including research and development of cell therapeutic product candidates, expansion of business units, strategic transactions and other general corporate purposes."

Read the full release at Neostem.com. 

Brean Murray, Carret & Co. on Indenix: "INFORM-SVR Data Has Negative Implications for IDX184 – All-Oral Regimen" ($IDIX)

Idenix Pharmaceuticals, Inc. (IDIX) is engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Building on its expertise in nucleoside chemistry and other small molecule chemistry and biology, the company is well positioned to become a leader in antiviral pharmaceuticals. Idenix's current focus is on the treatment of hepatitis C virus (HCV) infections. The company has previously discovered and developed antivirals for the treatment of hepatitis B virus (HBV) and HIV/AIDS.

Brean Murray, Carret & Co. has released a report on Idenix, classifying it as "Sell" with a price target of $3. 

The report states, 

"Roche posted an unacceptable relapse rate for patients taking mericitabine + danoprevir + ritonavir + ribavirin  for 12 weeks. Even at 24 weeks, the SVR rate was only 41%. We view this as a very good surrogate for any oral combination that includes IDX184, as we view the clinical antiviral activity of 100 mg IDX184 and 1000 mg of merictabine as equivalent. We believe Idenix (IDIX, $9.85, Sell) will need to explore regimens with durations of greater than 12 weeks to be effective. Given that the company has yet to initiate preclinical tox work in excess of 12 weeks, we believe this could significantly delay clinical development and makes IDX184 substantially less attractive as a potential backbone therapy."

Read the full report here.  

Rodman & Renshaw on Synta Pharmaceuticals: "Ganetespib Demonstrates Preclinical Activity in Therapy Resistant Cancer at AACR" ($SNTA)

Synta Pharmaceuticals (SNTA) is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of internally-developed drug candidates targeting large therapeutic markets in clinical and preclinical development. 

Rodman & Renshaw has issued a report on Synta, giving it a "Market Outperform" rating and an $8 price target. 

The report states,

"Although the data presented by the company at AACRprovide compelling potential development paths for ganetespib down theline, in our view these data will have minimal impact on SNTA sharesover the coming months. Rather, SNTA’s valuation is derived primarilyfrom ongoing clinical trials of ganetespib in lung cancer. In our view, asresults from the Phase IIb portion of the GALAXY trial and the separateALK+ study become available, SNTA shares will migrate higher fromtheir current levels of ~$230MM to a market cap 2-3 fold higher."

See the full report here.

Aastrom ($ASTM): Molecular Therapy Publishes Data for RESTORE-CLI

Aastrom Biosciences (NASDAQ: ASTM) announced that final results from the company's RESTORE-CLI Phase IIb clinical trial for ixmyelocel-T were published in the peer-reviewed journal MolecularTherapy. The Phase IIb clinical results demonstrated that treatment with ixmyelocel-T improved time to treatment failure in patients with critical limb ischemia (CLI) compared to the control group, and in the subgroup of patients with wounds at baseline demonstrated an improvement in amputation free survival. A total of 48 patients were treated with ixmyelocel-T and 24 received a placebo. Adverse event rates in both groups were similar. Patients in the treatment arm showed a 62% reduction in risk relative to placebo in the primary efficacy endpoint of time to first occurrence of treatment failure. A post hoc analysis of the subgroup of 45 patients with wounds at baseline resulted in a 77% risk reduction in time to first occurrence of treatment failure and a positive trend in the Phase III endpoint of amputation-free survival.

Daily Dose Take-Away: This data clearly suggests that ixmyelocel-T (expanded bone marrow) is active and impact the course of the disease. The Phase 3 trial is now funded and well powered. While its been a long road, Aastrom fundamentals are moving in the right direction.

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Conference Call 4/4/12: Cleveland Biolabs ($CBLI): Update on BARDA development funding process

Cleveland BioLabs ($CBLI) announces that the company received a response from the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (BARDA) indicating that BARDA has declined to invite the company to submit a full proposal at this time for continued development funding of CBLB502 as a radiation countermeasure.

Notwithstanding this notification, the company plans to continue the development of CBLI502 as a radiation countermeasure without interruption. Management states..." We will keep pursuing additional funding from various governmental agencies, including BARDA and our existing Department of Defense funding partners at the Chemical Biological Medical Systems and Defense Threat Reduction Agency."

There will be a conference call tomorrow Wednesday April 4, 2012 at 9:00 am 877-643-7158 (US) or 914-495-8565 (International).

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Rodman and Renshaw update on $KERX

Perifosine Strikes Out – Zerenex at Bat – A Potential Home Run Opportunity

Rodman and Renshaw update on KERX (PDF)
 
Summary: X-PECT Trial Fails to Meet Primary Endpoint – Removing All Perifosine Revenues from Model Today, Keryx announced that the Phase 3 X-PECT trial for the treatment of metastatic colorectal cancer failed to meet its primary endpoint of overall survival (OS). During the conference call, management elaborated that the median OS observed in the control arm of capecitabine + placebo was significantly higher than any other historical control treatment investigated in other randomized trials for the similar patient population. Additionally, further analysis revealed no benefit of perifosine + capecitabine treatment in the KRAS wild type or mutant population, or any other subgroup of patients. No further details regarding the difference in the survival between the treatment and the control arm, or the toxicities related to the treatment were provided. The management further indicated that given the failure of the X-PECT trial, the recruitment in the Phase 3 multiple myeloma trial may be affected, and the company is contemplating whether to continue the Phase 3 trial of perifosine with Velcade and dexamethasone in relapsed / refractory multiple myeloma patients. In our opinion, the company will likely shut down all clinical programs involving perifosine in an effort to conserve cash.
 
Phase 3 Zerenex Trial for Hyperphosphatemia to Report in 4Q12 During the call, the management also reminded investors about the ongoing Phase 3 trial evaluating Zerenex for the treatment of hyperphosphatemia in end-stage renal disease (ESRD) patients. Keryx is conducting a 58-week long-term, multicenter, randomized, open-label, safety and efficacy Phase 3 trial evaluating Zerenex, a phosphate binder, in 440 patients with ESRD on dialysis. During the call today, management reiterated that the data from the Phase 3 trial is expected to be available in 4Q12, with potential filing of the NDA and MAA in 1H13. In our opinion, the long-term study of Zerenex has a higher than average likelihood to succeed given that the short-term Phase 3 trial of Zerenex in ESRD patients met its primary endpoint of demonstrating a dose response in the change of serum phosphorous from baseline to day 28 (p-value < 0.0001). Of additional significance, Zerenex may reveal additional benefits in combating anemia if the Phase 3 data demonstrate a reduced need for intravenous and/or EPO blood cell stimulating drugs such as Procrit, Epogen and Aranesp.
 
Zerenex Market Potential We would like to remind investors that the US market for phosphate binders in the dialysis setting is approximately $700 MM and worldwide the market is approximately $1.2 BN. The 25% year-over-year growth in the phosphate binding market over the past 5 years has been driven by an increased incidence of dialysis with a growing diabetic population, as well price increases from market leader Genzyme for Renagel and Renvela. We believe that Zerenex has the potential to address the deficiencies among marketed phosphate binders, and capture 14% of the hyperphosphatemia market, corresponding to peak US revenues of approximately $250 MM by 2018, if successful.
 
Quick Take We are reiterating our Market Outperform / Speculative Risk rating but lowering our target price of $8 to $3 based on a discounted 2015 revenues and earnings multiples analysis. In our opinion, the failure of perifosine is a temporary setback, and provides an opportunity to a value-oriented investor to invest in the potential of the Zerenex franchise. The potential cost-savings benefit, combined with previous efficacy data, makes Zerenex an attractive treatment option in the approximately $700 MM U.S. market for agents that lower phosphate in ESRD patients on dialysis. We believe that Keryx represents a significantly undervalued and underappreciated company and is potentially suitable for the risk-oriented investor.

Derma Sciences ($DSCI) Raises $19.7 million

Derma Sciences (NASDAQ: DSCI) raised $19.7 million through the sale of 2.1 million shares at $9.25 in a follow-on underwritten by Piper Jaffray. Derma plans to begin Phase III testing next half of DSC127 for diabetic foot ulcers. The compound is an angiotensin analog. Derma also markets dressings for wounds and burns.  

DSC127 is an analog of a naturally occurring peptide, Angiotensin. It has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization. Additionally, histological examination has shown that DSC127 accelerated collagen deposition six-fold. All these help to accelerate dermal tissue repair. One potential method of action is the up-regulation of mesenchymal stem cells (MSCs) at the site of injury. MSCs originate in the human embryo and are considered to be multipotent — a type of stem cell that has not yet adopted a specific cellular phenotype. Such cells have the ability to differentiate into various types of cells found within the human body, including fibroblasts, adipose cells, muscle cells, bone cells, and skin cells.

The patented amino acid peptide DSC127 optimizes the well published wound healing capabilities of Angiotensin while removing all blood pressure effects of the compound.

Extensive pre-clinical studies have demonstrated the efficacy of the compound in accelerating healing and reducing scar formation. Pre-clinical studies thus far have shown:

• Improved in-growth of host tissue into artificial skins
• Accelerated healing in full thickness skin excision wounds in rats and diabetic mice
• Accelerated healing in partial thickness thermal injuries in guinea pigs
• Accelerated healing in a random flap skin model in rats Improved scar reduction in rats

Phase 1 is completed and top line Phase 2 data appears to have been presented last fall. The next step will be pivotal (phase III) studies.

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