As these clinical and commercial opportunities in VivaGel® and drug delivery advance towards important inflection points, the solid cash balance positions Starpharma well for creating significant additional value. The above activities are further supported by Starpharma’s strategy in agrochemicals, which provides broader application of Starpharma’s dendrimer technology.
Operating and investing cash outflows were A$4.9 million for the quarter. This expenditure relates to all Starpharma programs, including the two phase 3 clinical trials for VivaGel® R-BV, the phase 1 clinical trial of DEP™ docetaxel, and regulatory activities.
“This quarter has been another period of substantial progress for Starpharma. With two exciting clinical programs underway, a high level of activity with our partnered drug delivery programs, the VivaGel® condom in market and other applications underway, and a strong cash position the company is very well placed to capitalise on,” said Starpharma Chief Executive Officer Dr Jackie Fairley.
SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2015.
DEPTM docetaxel dosage levels exceeds the most commonly used Taxotere® dose
Majority of sites in phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (R-BV) recruiting participants
Regulatory submissions for VivaGel® Symptomatic Relief of bacterial vaginosis
Continued Australian rollout of VivaGel® condom
Increased activity in partnered drug delivery and agrochemical programs
Solid cash balance of A$34.7 million
During the quarter, activities have progressed across all of Starpharma’s programs for VivaGel®, drug delivery and agrochemicals. These include the two active clinical programs – the two phase 3 clinical trials for VivaGel® to prevent recurrent bacterial vaginosis (R-BV) and the phase 1 clinical trial of DEP™ docetaxel. The reported cash balance at 31 March 2015 of A$34.7 million supports these activities.
In drug delivery, the phase 1 clinical trial of DEP™ docetaxel continues to show very encouraging clinical data, with the drug remaining very well-tolerated and no neutropenia or hair loss observed to date with a number of patients having received multiple (up to 6) cycles of DEP™ docetaxel. Approximately 50% of the anticipated number of patients have now been recruited across four Australian sites with dose levels now above the most commonly used dose for Taxotere®, a dose at which a vast majority of patients typically experience neutropenia and hair loss. A number of patients being treated with DEP™ docetaxel have exhibited potential anti-cancer activity, across a range of tumor types. This has been achieved despite the absence of dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP™ docetaxel not yet being reached.
Starpharma Holdings Ltd today released an update to the progress of its phase 1 clinical trial of DEP™ docetaxel for advanced solid cancers. The DEP™ docetaxel dose level now exceeds the most commonly used dose for Taxotere® of 75mg/m2, with no dose limiting toxicities (DLT), including neutropenia, having been observed to date.
Approximately 50% of the anticipated number of patients have been recruited into the study and dosed with DEP™ docetaxel. Several patients have received multiple (up to 6) cycles of DEP™ docetaxel.
Available data show that DEP™ docetaxel has been very well-tolerated, with no observations of neutropenia to date. According to the available product information for Taxotere® (currently marketed docetaxel formulation), neutropenia occurs in virtually all patients given 60mg/m2 to 100mg/m2 of Taxotere®, and the most severe (grade 4) neutropenia occurs in 75% of patients given 60mg/m2 of the product. The clinical data for DEP™ docetaxel are in line with preclinical studies in animals that showed that DEP™ docetaxel eliminated the neutropenia seen with equivalent doses of docetaxel alone whilst enhancing anticancer efficacy.
There have also been no reports in the trial of vomiting or hair loss related to the DEP™ docetaxel treatment. By comparison these events occur in a significant proportion of patients receiving Taxotere® as monotherapy.
In contrast to therapy with Taxotere®, which is formulated in polysorbate-80, a detergent that can cause significant hypersensitivity reactions, patients receiving DEP™ docetaxel therapy do not need to receive pre-treatment with corticosteroids (cortisone) because DEP™ docetaxel is detergent free. Additionally, patients receiving DEP™ docetaxel therapy have not required prophylactic treatment with anti-emetics (to stop nausea/vomiting).
GPDB) announced today that its Board of Directors has approved a plan to purchase back as many as one million shares of its common stock, representing up to 60% of its shares in the public float.
Commenting on the decision, GPDB CEO, Rod Smith stated, "The current price is ridiculously low in light of our recent achievements and expectations for significant growth this year. Given the underlying strength of GPDB business and the recent turbulence in the equity markets, we think our current stock price is undervalued. Therefore, we believe the stock buy-back program is in the best interests of our stockholders."
"Look at it this way," says Smith, "2,000 Health Merchants x 1,000 customers shopping monthly, spending their grocery budget on CLEAN foods...do the math. It doesn't take long to understand why we are going to start buying back our common stock in the public float!"
The Board's decision came at the same time GPDB announces the launch of its national Health Merchant Enrollment Tour to establish 2,000 Health Merchants across the country. Rod Smith and "the Company plans to promote enrollment in 23 cities beginning on May 13th in the greater Salt Lake City area of Utah and continuing through Florida, New York, Massachusetts, South Carolina, Illinois, Texas, Minnesota, Colorado, Arizona, Washington and California. "And back again," Smith adds, "until we achieve our goal before the end of the 2nd quarter."
Smith will be on the road meeting with audiences in each city. Audiences will be comprised of 200-300 alternative health care practitioners, chiropractors, health store owners, farmers market administrators, pharmacists, health and lifestyle bloggers, nutritionists, health coaches, dieticians, personal fitness trainers, social media moms, association directors and non-profit administrators-all of who are potential Health Merchants.
After a fantastic 2014, we are tremendously excited about the opportunities this year and beyond. We are deeply grateful for the continued faith and effort of our extended CytoSorbents family: our patients and their families, the physicians and nurses on the front lines using our therapy, our shareholders, advisors, Board of Directors, distributors, strategic partners, research collaborators, and importantly, our more than 50 dedicated employees and consultants both here and in Berlin, Germany. Together, we can help revolutionize the treatment of deadly inflammation, and help give patients a fighting chance.
Finally, we fondly remember Joseph Rubin (1938-2014), our co-founder and Board Director, whose unwavering faith in the potential of our CytoSorb® technology to help people remains an inspiration to us all.
Dr. Phillip Chan, MD, PhD
Chief Executive Officer
Before I conclude, I should comment on the potential use of CytoSorb® as a rescue therapy for "cytokine release syndrome", or CRS, that can lead to cytokine storm in activated T-cell immunotherapy cancer treatments. This is one of the most promising and exciting areas of cancer research where a patient's own white blood cells (T-cells) are engineered to recognize and kill cancer cells. This is a strategy being pursued by major corporate and university alliances such as Novartis/University of Pennsylvania, Juno Therapeutics/Memorial Sloan Kettering/Fred Hutchinson Cancer Center/Seattle Children's Research Institute, Celgene/Bluebird Bio, Kite Pharma/National Cancer Institute, GlaxoSmithKline/Adaptimmune, Merck KGaA/Intrexon/MD Anderson, and Pfizer/Cellectis. In a number of studies, the use of activated T-cells has led to the "cure" or remission of many refractory leukemias and other cancers. Common to all of these activated T-cell therapies is the potent stimulation of the inflammatory response, leading to an expected extended "flu-like" syndrome in patients, characterized by high levels of cytokines. However, CRS can spiral out of control, despite the use of tocilizumab and other prophylactic measures, leading rapidly to multiple organ failure and often death. CRS is exactly what CytoSorb®was designed to control and we believe that CytoSorb® represents a potentially unique rescue therapy to treat immune overstimulation in T-cell immunotherapy. While we are still in the beginning phases of exploring this new opportunity, CytoSorbents already has several initiatives underway.
Meanwhile, the FDA and Device Sponsor would work together to specify the clinical trial design and "least burdensome" efficacy and safety data needed for early marketing approval, leaving the proof of more stringent efficacy to the post-market period. The end result is that devices that are safe and achieve EAP Designation have an opportunity to get to U.S. approval and commercialization much faster, and with less regulatory risk. We believe this new program could benefit CytoSorbents as CytoSorb® currently targets the treatment of many life-threatening conditions such as sepsis, acute respiratory distress syndrome, severe acute pancreatitis, trauma, and many others that do not have effective treatments. As we move forward with our REFRESH cardiac surgery trial in the U.S., we plan to aggressively pursue this EAP opportunity for critical care applications in parallel, and foster open collaboration with the FDA.
We have started 2015 in the strongest financial and commercial position in our history, well-capitalized with a healthy cash position, no debt, and the highest international awareness and interest in our CytoSorb® therapy that we have ever seen. Although we face some potential challenges such as the weakness in the Euro, the need to strengthen our direct sales force, and the unpredictability of timely country-specific product registrations, we continue to believe that the many potential opportunities for significant future growth greatly outweigh these near-term concerns. As detailed in our April 7, 2015 press release responding to Frequently Asked Questions, we have a clear strategy and plan on how to drive long-term, sustainable growth of our business.
To be clear, the diseases we treat are some of the most complex life-threatening conditions in medicine for which no effective therapies exist, and where the risk of death is still one in every three patients despite the best medical treatment. We have no expectation that CytoSorb® will work every time. But with the collaboration and experience of a growing number of physicians who have collectively performed more than 5,500 human treatments to date, we have made significant progress toward identifying which diseases and patients best respond to CytoSorb® therapy. Centralized data from our recently launched International CytoSorb® Registry and from the more than 50 planned investigator-initiated and company-sponsored studies (a dozen of which are already enrolling patients), will also be invaluable to understanding the full potential of CytoSorb®. We now have the funding and clinical development team to advance our trial agenda more aggressively, particularly in the areas of sepsis and cardiac surgery - our two largest markets.
A significant new opportunity has emerged that may accelerate U.S. approval of CytoSorb® for critical illnesses such as sepsis. The FDA has recently issued new guidance on two related topics: the Expedited Access Pathway (EAP) program and the Balancing of Pre-market and Post-market Data Collection for Devices Subject to Premarket Approval. Together, the EAP and Data Collection programs are designed to facilitate and expedite the U.S. approval of medical devices that treat life-threatening or irreversibly debilitating conditions that have no approved alternative treatments. Similar to "Breakthrough Therapy Designation" for drugs and biologics, devices that achieve EAP Designation would be eligible for more intensive FDA guidance and collaboration with senior managers, and priority review.
Dear Fellow Shareholders and Friends,
By all measures, 2014 was an outstanding year for CytoSorbents, highlighted by many significant achievements. We exceeded our internal forecasts for CytoSorb® sales growth, fueled by broadening physician interest and usage in a growing number of countries. We established or strengthened key strategic partnerships with Fresenius Medical Care, Biocon, and a major global cardiac surgery company, and expanded distribution of CytoSorb® to 29 countries worldwide. These initiatives have the potential to catalyze significant future growth. We also began the clinical trial process needed to bring CytoSorb® home to the U.S., initially for the application of cardiac surgery, and possibly later for other applications. Finally, with the support of our shareholders, we became a NASDAQ-listed company, giving CytoSorbents much broader visibility in the investment community and significantly increasing liquidity for shareholders.
With that said, the most exciting part of this journey has been the growing number of stories of how CytoSorb® has helped, in some way, save the lives of ordinary people like you and me. These patients find themselves in the intensive care unit because of common life-threatening conditions such as sepsis and infection, lung injury, trauma, burn injury, pancreatitis, liver failure, and many others where inflammation plays a potentially deadly role. Left untreated, severe uncontrolled inflammation can lead to multiple organ failure, where patients spiral out of control and become unresponsive to therapy, leaving families and physicians with the difficult prospect of having to potentially withdraw life-support. The fact that CytoSorb® therapy has been used to reduce the "fuel to the fire" of this inflammation and help bring many of these people back from the brink of death is, to me as a physician, nothing short of remarkable.
a whole bunch of 'investors' jumped on the bandwagon and have little or no interest in the big story, just trying to make a few bucks. If I bought in at 14, i would have sold too, but I've been in for a few years now and have no intention of selling till this becomes the google of blood filtration or the apple of the diagnostic/cure future.
Neovacs will manage and fund all product development and regulatory submissions for its immunotherapy products and act as the sponsor company for the future clinical trials. Stellar will supply GMP grade KLH to Neovacs according to agreed specifications, quantities, and pricing, as well as maintain a master file with the U.S. FDA for the KLH product. Stellar will also provide professional, technical, and regulatory support to Neovacs. The agreement has an initial five-year term, which may be renewed by Neovacs in one-year increments.
Neovacs' lead product candidate, IFNa-Kinoid, has successfully completed a Phase I/IIa clinical trial for lupus. The Company's Scientific Advisory Board (SAB) members have announced their full support for the planned Phase IIb trial of IFNα-Kinoid in approximately 160 patients in Europe, Latin America and Asia. This Phase IIb study is expected to begin mid-2015. A U.S. Phase IIa trial of IFNα-Kinoid for the treatment of lupus in the U.S. is expected to commence by early 2016.
"We have enjoyed a long-standing and successful relationship with Stellar Biotechnologies as our key KLH supplier," said Miguel Sieler, Chief Executive Officer of Neovacs. "This new agreement with Stellar comes at a pivotal point for Neovacs, as we are preparing to launch multicenter clinical trials with IFNα-Kinoid and are strengthening our U.S. operations through the recent formation of a wholly-owned subsidiary, Neovacs, Inc. The new supply agreement will ensure that Neovacs has access to a scalable, stable supply of GMP grade KLH as our Kinoid products advance through clinical development and we prepare for the expected commercial launch."
"Expanding our supply commitment to Neovacs to include late-stage clinical trials and expected initial commercialization is an excellent demonstration of the growing commercial prospects for our core KLH business," said Frank Oakes, President and CEO of Stellar Biotechnologies. "We also see this is as positive validation for the use of Stellar KLH™ in the development of new immunotherapy treatments."
Under the terms of the agreement, Neovacs will purchase Stellar KLH™ for use in its proprietary KLH-based Kinoid immunotherapies in the European Union, Latin America, Asia, the U.S. and Canada. Neovacs will use Stellar KLH™ for its planned Phase II and Phase III clinical trials and for expected commercial manufacturing of its products for up to one year following market approval.
Companies Sign KLH Supply Agreement for Neovacs' Kinoid Clinical Trials and Initial Commercialization
PORT HUENEME, CA and PARIS, FRANCE -- (Marketwired) -- 04/01/15 -- Stellar Biotechnologies, Inc. and Neovacs S.A. today announced that the Companies have entered into an expanded supply agreement to meet Neovacs' requirements for Keyhole Limpet Hemocyanin (KLH), a primary component of Neovacs' proprietary Kinoid immunotherapy technology.
The new agreement extends and expands the supply contracts previously in place between the Companies, in order to ensure the continued supply of Stellar KLH™ to Neovacs during its Kinoid clinical trials and to support the expected commercial roll-out of Neovacs' lead product candidate IFNα-Kinoid, an immunotherapy being developed for the treatment of systemic lupus erythematosus ("lupus").
Stellar is a leader in the sustainable manufacture of KLH, an immune-stimulating protein widely used as a carrier molecule in immunotherapies under development for a variety of disease indications. Immunotherapy uses a patient's own immune system to target and treat diseases. KLH can only be produced from a scarce marine source. Stellar believes it is the only company with the proprietary technology to manage sustainable, scalable production of GMP quality KLH to meet future pharmaceutical industry demands.
Neovacs is a leader in the development of active immunotherapies for the treatment of chronic autoimmune diseases. Neovacs' patented Kinoid technology combines a select cytokine of interest attached to KLH as the immune-stimulating carrier protein. The resulting immunotherapy uses the patient's immune system to generate antibodies against the targeted disease.
University of Cologne study over 1/3 enrolled at this time.
Output increased from existing facility. 20 sites screened in NJ and Pa. Narrowed to 6 places. Detailed site reviews under way.
Fresenius? Worlds leading dialysis company. Cytosorb to be a focal point in their strategy. Multi Country. Overall, things going well.
Recently trained first French cardiac surgical team. To be used in high risk procedures and will report back. Looking for expanded partnership.
Chan closing: Thanks... feel free to forward questions to amy vogel.
Level of interest? Past year record. Strong growth in use of our therapy in Europe and internationally. Interest in targeted communities are increasing dramatically. Efforts starting to pay off. Expect initial results of studies in coming months, should be catalyst.
What is purpose of registry? Effort for future development and therapy. First of its kind. To obtain medical evidence. Encouraging doctors to try using cytosorb.
When will sales force be back on line? Confident full strength by next quarter. We are hot topic in the medical community.
Status of IRB sites and approvals and when will enrollment begin? We will enroll 20 patients and all will get cytosorb. Looking for best center and sites. Contingent on IRB approval.
? Feedback from FDA was for separate pilot study, the current study.
Reception of registry? 30 centers engaged in accordance to FDA to provide robot data on Cytosorb usage. At ISICM earlier this month, presentation very well received.
Questions coming too fast for me to keep up....
Outlook for 2015
Demand and interest continues to remain strong for product.
$20 Billion opportunity in critical care. Unique product.
Removes the Fuel to the Fire. Approved for use in any situation where cytokines are elevated.
Used in 5500 cases to date.
Goal: To prevent or treat organ failure. Improve patient outcome and survival, decrease costs of ICU and Patient Care.
Based on competitive landscape, we have an opportunity to revolutionilze critical care medicine.
Massive unmet $20 billion unmet medical need in critical care
Sales are generating significant growth with 65% gross margins
Continueed geographic expansion.
Near Term Challenges -
Sales infrastructure expanded quickly, restructuring sales force. After much effort 4 let go in first quarter. German sales director promoted. Remaining team outstanding. Gap in direct sales territories resulting in lower sales. Should be better in 2015. Euro drop vs dollar, sales should show 45% year over year growth. Product sales are too dependent on the timing and size of orders and cannot yet be accurately predicted.
Expect that Q1 2015 CytoSorb product revenue will be in the range of $700,000 to $725,000. Adjusting for Euro equvalent of 800,000 to $850,000
Operating and Financial highlights
Product revenue 2014 $3,135,387 vs $821,787 for 2013
Gross margin 63%
'scratching the surface with distributors'
4th quarter sales 871K
Sales may fluctuate from quarter to quarter.
12 Trailing months product sales shows sales will remain strong
28,347,339 fully diluted common shares. Clean capital structure.
2014 was a great year for the company. Well Positioned. Strong year of growth. Sales of $3.1 Million Dollars in 29 countries. Tremendous interest from industry leaders. ISICEM 2015 was standing room only. More published case reports and studies. International CytoSorb Registry. New Website. Partnerships with global leaders. Biocon- hundreds of patients have benefited, agreement expanded. Biocon funding studies and publishing results. Fresenius Medical Care 6 country partnership. France, Seden, Norway, Finland, Denmark and Poland. Cardiac Surgery Initial Partnership. Top firms involved (Medtronic, Sorin, Maquet and Terumo)
Focusing on Generating Clinical Data. FDA approval of IDE for REFRESH Study. Expected to be completed this year, begins the clinical trial process to seek US FDA approval for CytoSorb. Built strong infrastructure to drive Clinical Data. Pivotal Trial Cardiac Surgery. US Air Force funded Trauma Pilot. 50 plus investigator intiated studies, many to be completed this year. European Registry. Finishing Germany dosing study.
Increased Investor Awareness. Beacon of Light award. Uplisting to NASDAQ. Avg daily trading value prior to uplisting 30000 now 200k. 6 investment analysts following company. Working actively with PR group for increased media coverage.
Waiting to hear about sales now.....
Pearsby, all companies don't make money until they do. Whats the point? A few more 'digs' like that and your fans may rethink your 'beloved' status.
I find it somewhat ironic and amusing that if what you say is true, they're trying to stop the bleeding in more ways than one.