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February 12, 2009
Dear Shareholder,
As we head into the new year, let me start by offering you my sincere wishes for personal and professional good health in 2009 and beyond.
The topic of financial good health is one that has been front and center for many us lately, given the negativity surrounding the nation’s economy and capital markets that bombards us at every turn. The daily news reports suggest conditions may even worsen before they get better.
Though these current economic conditions certainly make financing much more challenging for companies seeking capital, we begin the year with cautious optimism. In the third quarter of 2008, we were fortunate to have closed on the latest round of funding with Brencourt Advisors, LLC, a well-respected institutional investor that continues to support us in many fruitful strategic discussions. Additionally, we continue to develop relationships with potential funding partners while utilizing our industry connections to pioneer new alliances.
Our simple goal remains to continue fueling the development and collection of scientific data to advance our programs and initiatives. We achieved significant progress in 2008, with key activities including, but not limited to: adjuvant mechanism studies initiated in human skin models; wound healing demonstrated in pig model of human surgical wounds; efficacy studies in neutropenia models completed in animals; human embryonic stem cell activity demonstrated in preliminary studies; human adult hematopoietic stem cell stimulation of differentiation (especially precursors to the disease-fighting granulocyte/macrophages); and reduced severity and lethality of pandemic influenza (H5N1) demonstrated in secondary animal model (ferrets).
The company is aggressively moving forward this year on advancing neutropenia model data, demonstrating wound healing mechanisms at University of Texas Southwestern Medical School, and initiating sponsored, as well as third party-funded, idiopathic pulmonary fibrosis studies. We are progressing with our IND submission initiatives and expect to out-license various indications for our compounds.
The increased visibility of stem cell companies such as Geron and Osiris, academic programs such as the California Stem Cell Initiative, and the anticipated removal of restrictions on Federal funding for certain stem cell research (as supported by the new administration in Washington) provide further justification for our development efforts in human adult and human embryonic stem cells.
Since my last letter, we also have secured new relationships that can assist us in furthering the objectives outlined above. The Trout Group LLC, a leading international life sciences investor relations and strategic advisory firm based in New York, is one such relationship.
With extensive institutional investor contacts in the United States and abroad, and a client roster featuring approximately 40 life sciences companies worldwide, The Trout Group will facilitate our exposure to the capital markets by developing relationships with portfolio managers, investment bankers and industry analysts. It also will be responsible for disseminating our news and updates to shareholders and other interested groups, informing them of our latest developments.
We move forward fully aware that the institutional investment community’s taste for risk-taking has softened, compared to even a few years ago. However, a recent BioCentury report suggested that this could be an active year for long-term and venture investors with free cash to invest, as many public company assets have been depressed to highly attractive prices. One fund manager quoted felt this was an ideal time to be building a portfolio: “I would not be surprised in if in 2012 or 2013 we look back at this time and say what a fabulous year to have been investing—2009 is going to be a great year for those who have patient capital and can hold on to their investments.”
For our part, we have implemented strategic reductions of administrative staff positions and office space square footage to help extend our financial resources. We remain wholeheartedly and passionately committed to success. And, we consider it a privilege to maintain your confidence and support of our mission.
As 2009 unfolds, I look forward to updating you regularly with positive news of our progress. Please do not hesitate to contact Chief Financial Officer John Fermanis at (480) 922-3926 with your questions.
Best regards,
Michael K. Wilhelm
Chief Executive Officer
October 30, 2008
Dear Investment Community,
I hope you find value in my messages to you. I'd like for you to know how often I have planned to write this letter. Many times it was on my daily schedule, only to find that it eventually moved to the following day or week. This was not a result of disinterest with keeping you informed, but rather an attempt to bring you pertinent information while hoping for some positive movement in the equities markets, banking industry and overall morale of the investing community. This strategy was partially effective. Obviously, we have not seen our markets rebound or even stabilize for that matter; quite frankly, it cannot matter to us at ImmuneRegen Biosciences, Inc. at this time. What is critical to our company and the company's value is scientific progress and great data that advance programs and initiatives. This we can discuss and I am happy to highlight.
Since raising the most recent round of capital through Brencourt Advisors, LLC, a well-respected institutional investor, we have made significant progress with our two core scientific research programs. Moving them both in a parallel manner was a decision made based on the synergistic mechanisms by which our compound Homspera™ demonstrates activity and efficacy in the indications of radiation – and possibly chemotherapy-induced neutropenia and wound healing acceleration. Of course, the underlying mechanism of stem cell activity and differentiation is suggested to play a significant role in all of our areas of development, from infectious disease, adjuvant and wound care to differentiating and possibly mobilizing hematopoietic stem cell (HSCs).
The company is moving aggressively toward the clinical and human studies in wound healing and blood cell depletion, and we expect to be on target with our IND submissions on or before June 2009. We continue to employ some of the more impressive and effective people in their respective fields, enabling us to make the most informed decisions and providing our team with the tools necessary to execute as effectively as possible. These individuals have been learning about our compound and their prospective indications, as well as various applications - and have provided ImmuneRegen with the guidance and comfort of knowing that we are on the right course. They have also informed us that the actions that are being implemented are instrumental for successful submissions, timely, and just plain, "spot on".
These current economic conditions certainly make financings much more difficult for those seeking capital. Long-term we have additional capital needs, yet we are fortunate to have just closed the last round of funding with Brencourt Advisors, LLC. We are committing our best efforts to be as effective at building shareholder value by developing relationships that will potentially and expectedly lead to a significant partnership for our drug candidate. Our objective is to continue to build value for our shareholders. As ImmuneRegen has evolved from an early preclinical-stage company to a later-stage scientific development company that is heading into the clinic, we feel grateful for the people and resources that we have in place, as well as for the plans that have been executed. We are also very thankful to our shareholders and our outside partners who have assisted in financings and business relationships.
As we approach the holidays, I hope to bring you another update prior to the end of the year. Either way, please be on the lookout for upcoming press releases. Meanwhile, I will continue to forward all public communications to you.
Happy holidays and best regards,
Michael K. Wilhelm
Chief Executive Officer
June 12, 2008
As I announced in my earlier update letter, dated March 28th, 2008, our new strategic direction includes a primary focus on building upon the scientific data that originally demonstrated the effects of our compound, Homspera®, on adult stem cells and simultaneously developing relationships that will allow us to license the compound for therapeutic development. Since that time, several research studies have been completed by leading stem cell scientists that examined the effects of Homspera on human, adult stem cells. After removal from human bone marrow, these cells were exposed to Homspera and evaluated for changes in their growth and maturation. The basis of these experiments was to deepen our understanding of how Homspera stimulates the immune system and thus support more aggressive licensing efforts. These studies also enabled us to fulfill the second of three financial milestones ahead of the schedule specified in our funding agreement with Yorkville Financial Advisors. We are pleased to share with you that with these results we expect to be better positioned to attract more advantageous pre-clinical licensing opportunities
Collectively, our findings demonstrate Homspera’s effectiveness in activating adult stem cells – specifically blood-forming (hematopoietic) stem cells. Homspera has been shown to stimulate differentiation of hematopoietic stem cells and increase the number of red blood cell, platelet and white blood cell precursors, the latter of which ultimately become the functional cells of the immune system. The effects of Homspera are greatest in enhancing granulocyte/macrophage precursors, which together comprise over 70% of the white blood cells in the body. Mature granulocytes and macrophages fight infection partly by engulfing and destroying invading microorganisms, a vital function of the immune system. We have seen results, using bone marrow from several human donors, where the addition of Homspera to stem cell cultures increases the formation of granulocyte/macrophage precursors to more than 200% of control values as indicated on the research reports we have received.
This data suggests Homspera may be of potential benefit in situations where regenerating and strengthening the immune system is imperative, as with individuals recovering from influenza or undergoing chemotherapy. More importantly, it also suggests an underlying mechanism of action for Homspera in cases of radiation poisoning. Upon exposure to ionizing radiation (X-rays or gamma rays), the dividing blood cell precursors of the bone marrow are the most easily damaged. We have demonstrated in multiple studies performed at various academic, commercial and governmental laboratories that Homspera increases circulating white blood cell counts in irradiated animals, negating this damage and ultimately contributing to an increased survival. These results can be explained, in part, by Homspera’s ability to increase white blood cell precursors.
While direct effects of Homspera on cells of the immune system, as well as cells of the skin, may underlie the effects seen in our infectious disease and wound healing studies, it is also possible that Homspera’s action on adult stem cells underlies these effects as well. The enhanced immune response seen in Viprovex-treated animals exposed to influenza virus or in animals exposed to virus particles in vaccines, where Viprovex has shown adjuvant activity, might follow directly from elevations in immune cells from bone marrow. Similarly the acceleration in wound healing we’ve reported in animals exposed to topically applied Homspera might reflect an enlistment of adult stem cells to replace injured skin cells. Additional research and studies will be needed to confirm any such conclusions.
This stem cell data from these studies helps to bridge our diverse portfolio of research studies using Homspera and provides the company with confirmation of our scientific focus and anticipated long term success. Homspera’s ability to enhance stem cell activity follows the myriad of animal studies and the results we’ve reported previously for Homspera use in a wide variety of therapeutic areas such as radiation exposure, vaccine adjuvancy, infectious disease and wound healing. Furthermore, with this understanding reached from these studies, we anticipate that the blood disorder indications (noted in attached slide) will create additional licensing opportunities for the company.
We remain excited about our direction and confident that follow-on studies will confirm and extend the benefits that we have seen to date.
Michael K. Wilhelm
Chief Executive Officer
April 7, 2008
Dear Shareholder,
We are pleased to report that ImmuneRegen has successfully completed one of the three triggering milestones defined in Section 17 of the Form of Debenture between IR BioSciences Holdings, Inc. and YA Global Investments, L.P.
Results of a preclinical study on our synthetic peptide, Viprovex®, by the United Kingdom’s Health Protection Agency, Centre for Emergency Preparedness and Response, indicate efficacy in reducing the severity of H5N1 (avian flu). The findings suggest the possibility that Viprovex® enhances the immune system’s response to the influenza virus.
The Health Protection Agency’s “H5N1 Avian Influenza Virus: Ferret Study” found that all Viprovex-treated animals were more active than their corresponding controls throughout the nine-day study period, and exhibited less weight loss and hypothermia. None of the animals treated with Viprovex® showed the degenerative neurological symptoms of neck stiffness, hind-limb paralysis, diarrhea or labored breathing typical of the disease as seen in the untreated animals.
Previous animal and cell culture studies have shown Viprovex®, a derivative of ImmuneRegen’s adult stem cell-active compound Homspera™, to have an impact on the activation of components of the innate immune system. A major cause of flu-related deaths is the exaggerated response of the immune system to the rapidly multiplying virus, and this influenza study suggests Viprovex® has potential in dampening the pathology associated with the resulting immune response. While no significant difference was found in the virus levels in nose, lung and brain between test and control animals, extracts from the spleen of test animals that received the antiviral drug Viprovex® intranasally exhibited a lower concentration of the virus than extracts from the corresponding controls.
The results from this study strengthen our confidence that Viprovex® may provide treatment applications against a potential influenza pandemic. I’m sure you share my enthusiasm about these study results that are important steps in ImmuneRegen’s goal to become a key player in this high-opportunity arena.
Michael K. Wilhelm
Chief Executive Officer
March 28, 2008
Dear Shareholder,
I am proud to inform you that ImmuneRegen BioSciences has realized a major milestone in its journey. With the release of exciting new stem cell results from our development partner HemoGenix®, the company has now reached the point of maturation where we believe it can make the transition from a research and development company to a pre-clinical compound licensing company. Simultaneously with this letter, and reflecting the strategic evolution of the company, ImmuneRegen is releasing a new PowerPoint and website redesign to reintroduce the company to investors and industry partners.
During the past year, we have continued to fund studies and develop partnerships that have contributed greatly to our understanding of both the clinical indications of Homspera™ and the potential therapeutic benefit it promises. In the past year, we have signed additional partnering agreements that add industry validation to our work and bring the total number of our study partners to more than twenty. Our co-development relationships reflect enhanced interest by industry innovators in potential uses for Homspera in conjunction with other compounds currently in preclinical development. Most importantly, we have determined that our most efficient path to profitability can be achieved through the licensing of one or more of Homspera’s many potential applications by major pharmaceutical companies.
Licensing has become a more feasible strategy now that we are armed with a unified understanding of Homspera’s mechanisms of action (see Management Analysis section below). This determination is fueled by our belief that Homspera has multiple potential indications for use as an adult stem cell activation product. Since each potential licensee brings unique product development needs and capabilities, we will work to identify potential partners interested in our pre-clinical status and willing to invest early to capture the maximum value of a high-potential drug candidate. We believe that continuing product development may enable additional potential indications to be licensed at increasingly higher valuations.
These plans rely upon funding already in place. This year, Management has secured $2 million in funding from Yorkville Advisors, with an additional $1 million becoming available, at our option, in July. This funding guarantees the continued operation of the company and is expected to take us to the point where licensing revenues could bolster the support for continued growth of the company. Current growth is evident in the broad range of ongoing activities. Our scientific team is managing multiple studies with prominent laboratories and partners across the country. We have begun the required safety studies necessary to receive IND (Investigational New Drug) clearance from the U.S. FDA (Food & Drug Administration) enabling human clinical studies. We will continue to collect the necessary data to meet both internal milestones and those set forth in our most recent funding agreement.
Management Analysis of Unified Mechanism of Action
The new stem cell data supports our belief that Homspera can trigger resting hematopoietic stem cells (HSCs) to multiply, become mature blood cells and migrate from the bone marrow to the peripheral circulation. These newly differentiated HSCs replenish damaged white and red blood cells and platelets, enabling reconstitution of the immune system, oxygen carrying capacity and primary blood-clotting mechanism, respectively.
We believe that our previous findings regarding Homspera can, in part, be explained by Homspera’s stimulation of HSCs. More specifically, studies indicate that a lethally irradiated animal suffering from massive immune cell loss can be protected by Homspera’s stimulation of HSCs to replenish those lost cells, thus by increasing the numbers of white blood cells, the body becomes more capable of fighting off the infections that are partially responsible for post-radiation lethality. Additionally, the augmented immune system is better able to identify and target invading micro-organisms or foreign proteins by mounting antibody and/or cell-mediated responses to the intruders. Therefore, we believe that the diminished amount of virus detected in the lungs and nasal passages of infected animals treated with Homspera, is partly an effect of Homspera’s stem cell activity.
We believe that there are likely to be other direct effects of Homspera on cells of the immune system as well as other cell types. For example, Homspera-treated animals demonstrate activation of receptors on cells of the immune system and an impact on molecules which regulate the immune system, either of which could lead to an increased immune response, an effect likely independent of stem cell activity, but we believe dependent on binding of Homspera to its specific receptor molecule on the surface of immune cells. This receptor/Homspera interaction triggers many biochemical pathways that can result in changes in cell activity and trigger a positive response to antigens or other chemicals.
Thus, we believe that the radio-protective, anti-microbial and vaccine adjuvant responses can all be attributed, at least in part, to the ability of Homspera to stimulate hematopoietic stem cells, and, in part, to the interaction of Homspera with its receptor on cells of the immune system.
Based on the aforementioned findings and theories we will be executing our new strategic plan focusing the resources of the company on licensing our compound for development in the adult stem cell marketplace with a top-tier partner. During this time, we will pursue the development of stem cell studies and clinical indications, but will continue to fund, at a lesser level, studies in radiation, infectious diseases, wound care and cosmetic applications. It is my belief that this strategy will represent the fastest path to profitability and the greatest hope of increasing and sustaining shareholder value.
I look forward to sharing this journey with all of you.
Michael K. Wilhelm
Chief Executive Officer
August 16, 2007
Dear Shareholder,
The previous year has been a noteworthy one for ImmuneRegen BioSciences. Our scientific and business activities have accelerated, and the company has recently announced several noteworthy achievements and events such as acquisition of study results, formation of collaborative and co-development relationships as well as presentations at conferences and to the FDA and NIH. The response by these agencies of the Department of Health and Human Services remains quite positive as we continue to deliver additional data in multiple areas of both scientific and product development interest and having potential commercial appeal.
Current research programs include microbiological infection such as anthrax bacillus, and influenza (including avian influenza vaccine adjuvancy), in addition to radiation exposure (to both lethal and sub-lethal/therapeutic doses). Results of our influenza studies indicate that Viprovex® lowers viral load 90-99% in nose and lungs of treated animals, as well as lowers the magnitude of the virus-induced decreases in body weight and temperature. These studies also indicate that Viprovex® decreases the inflammatory reaction in the lungs of infected animals, even in the presence of Roche's influenza treatment and preventative, Tamiflu(R). The company is continuing Tamiflu/Viprovex® studies and they are underway. Our radiation exposure studies, originally for biodefense applications and terrorist attacks have been extended to include potential cancer therapy applications. The radiation results have indicated recovery of circulating white blood cells, and potential stimulatory effects on stem cell proliferation and/or maturation. Wound healing is also a market in which we anticipate forthcoming success. Results from recently concluded studies indicate positive effects in the area and we expect our drug candidate to continue to demonstrate positive results as a potential growth factor. We also believe that our recently announced relationships with companies such as Uluru Inc. will expedite our efforts in wound healing.
In the opinion of management the current stock valuation does not reflect the newly acquired data and relationships. We continue to successfully develop business relationships with potential partners and advance our product development activities in multiple, sizeable markets. For example, the biodefense and pandemic influenza market has been estimated at a combined total of $6.1 billion with seasonal influenza opportunities, as a therapeutic or adjuvant to vaccination representing $2 billion total market revenues in 2006. Cancer therapies for mitigating side effects to toxic therapy and/or potentially playing a therapeutic role in the stem cell area of medical treatments has a combined commercial market worldwide estimated at $16.1 billion in revenue. Additionally, we hope to achieve continual successful results in the wound healing studies that we have currently partnered with Uluru, Inc. We are collectively working toward adding additional pharmaceutical company partnerships so we can develop effective wound healing treatments that can theoretically address a broad range of applications: diabetic ulcers, trauma, surgical wounds, day to day cuts and scrapes. For 2006, the global wound care market represented $7 billion in sales. A recent report by Global Industry Analysts, Inc. dated July 9, 2007 stated that the wound care products market is to reach $15.3 billion by 2010, driven by sealants, growth factors, and skin replacements. Also, the US market alone should be over $6 billion by 2010. We are very excited about this work and are pleased as well as honored to be working with our current partners in these areas. As our company continues to hit milestones, it is our belief that we will have more visibility to Wall Street, industry peers, potential partners and the scientific community.
The outside laboratories that have been conducting research for us have been performing excellent work and we appreciate the relationships that we have developed, maintain, and may expand as we seek new and experienced partners in our development efforts (most recently VaxGen and Uluru).
I am looking forward to announcing our next updates, results, conferences, etc. The relationships we are forging today based on our current data as well as anticipation of future data are very exciting and we hope to be able to discuss formalizing them over the next few months. Keep in touch with our updates by viewing our website www.immuneregen.com. We are available to answer your queries and hope that you will send an email to me at mwilhelm@immuneregen.com or to Dr. Siegel, Senior Director of Product Development and Regulatory Affairs hsiegel@immuneregen.com. We are happy to answer your corporate and scientific questions. Keep in mind that our responses can only reflect that information that is already publicly available.
Best regards,
Michael K. Wilhelm
Chief Executive Officer
ImmuneRegen BioSciences, Inc.
IR BioSciences Holdings, Inc.
About IR BioSciences Holdings, Inc.
IR BioSciences Holdings, Inc. is a development-stage biotechnology company. Through its wholly-owned subsidiary ImmuneRegen BioSciences, Inc., is focused on the research, development and licensing of Homspera®, an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. For more information, please visit www.immuneregen.com.
Statements about ImmuneRegen’s future expectations, including statements about the potential use and scientific results for ImmuneRegen’s drug candidates, science and technology, and all other statements in this press release other than historical facts, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen’s business, are subject to various risks and uncertainties. ImmuneRegen’s actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen’s periodic report on Form 10-Q for the three months ended June 30, 2008 as filed on August 14, 2008 and as amended on Form 10-Q/A, Amendment No. 1 filed on October 17, 2008, and, on Form 10-KSB for the year ended December 31, 2007 as filed on March 31, 2008 and as amended on Form 10-KSB/A, Amendment No. 1 filed on September 25, 2008 with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen’s proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements.
John N. Fermanis, Chief Financial Officer
ImmuneRegen BioSciences, Inc.
480-922-3926
jfermanis@immuneregen.com