Actinium Pharmaceuticals is developing targeted alpha therapies for cancer including Iomab-B and Actimab-A. Interim results from the ongoing Phase I/II trial of Actimab-A show it has eliminated peripheral blasts in 67% of patients and decreased bone marrow blasts by at least 50% in 53% of patients, with 20% of patients achieving bone marrow blasts of 5% or less. These results support further development of Actimab-A as a potential low intensity treatment for elderly acute myeloid leukemia patients.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn more.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn more.
Medical Device Post-Market Surveillance RequirementsEMMAIntl
Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring that they continue to monitor the safety/effectiveness of the manufactured devices that are on the market. The requirement for post-market surveillance (PMS) was implemented so that manufacturers understood that their device is still their responsibility even after it has left their manufacturing site and entered the market. PMS is intended to be a reporting system that manufacturers can utilize to continuously monitor device performance and learn from any mistakes such as adverse events...
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Tiziana Life Sciences is a dual-listed clinical stage biotechnology company focused on the discovery and development of novel molecules to treat human disease in oncology and immunology. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn more.
Medical Device Post-Market Surveillance RequirementsEMMAIntl
Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring that they continue to monitor the safety/effectiveness of the manufactured devices that are on the market. The requirement for post-market surveillance (PMS) was implemented so that manufacturers understood that their device is still their responsibility even after it has left their manufacturing site and entered the market. PMS is intended to be a reporting system that manufacturers can utilize to continuously monitor device performance and learn from any mistakes such as adverse events...
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Tiziana Life Sciences is a dual-listed clinical stage biotechnology company focused on the discovery and development of novel molecules to treat human disease in oncology and immunology. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn more.
Prescient Therapeutics (PTX:ASX) is an ASX-listed biotechnology company focused on improving outcomes for cancer patients by developing personal medicines, using CAR-T and targeted therapy approaches.
Universal CAR-T therapies like OmniCAR have the potential to take personalised cancer treatment to the next level, by combining the cancer-killing capabilities of a T-cell with the control and pharmacology of a drug.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical-stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Dócola is a social good organization with the only free care communication platform that consolidates thousands of free and low-cost patient education resources from the leading nonprofit, government, and commercial organizations in one marketplace. Plus, you can easily create and upload your own resources.
INNO HOLDINGS INC. is an innovative building-technology company with a mission to transform the construction industry with our proprietary cold-formed steel- framing technology and other building innovations
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a global innovation company focused on discovering and developing precision medicine innovations and deploying them into high-performing businesses. Aditxt’s diverse innovation portfolio includes: Adimune™, Inc., developing and designing a new class of therapeutics for retraining the immune system to address organ rejection, autoimmunity, and allergies; Adivir™, Inc., focused on identifying, developing and commercializing new ways to treat infectious diseases; and Pearsanta™, Inc., offering convenient, rapid, personalized, and high-quality lab testing —anytime and anywhere at its CLIA certified and CAP accredited clinical laboratory based in Richmond, VA.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Boudoir photography, a genre that captures intimate and sensual images of individuals, has experienced significant transformation over the years, particularly in New York City (NYC). Known for its diversity and vibrant arts scene, NYC has been a hub for the evolution of various art forms, including boudoir photography. This article delves into the historical background, cultural significance, technological advancements, and the contemporary landscape of boudoir photography in NYC.
This tutorial offers a step-by-step guide on how to effectively use Pinterest. It covers the basics such as account creation and navigation, as well as advanced techniques including creating eye-catching pins and optimizing your profile. The tutorial also explores collaboration and networking on the platform. With visual illustrations and clear instructions, this tutorial will equip you with the skills to navigate Pinterest confidently and achieve your goals.
This document announces the winners of the 2024 Youth Poster Contest organized by MATFORCE. It lists the grand prize and age category winners for grades K-6, 7-12, and individual age groups from 5 years old to 18 years old.
Hadj Ounis's most notable work is his sculpture titled "Metamorphosis." This piece showcases Ounis's mastery of form and texture, as he seamlessly combines metal and wood to create a dynamic and visually striking composition. The juxtaposition of the two materials creates a sense of tension and harmony, inviting viewers to contemplate the relationship between nature and industry.
Fashionista Chic Couture Maze & Coloring Adventures is a coloring and activity book filled with many maze games and coloring activities designed to delight and engage young fashion enthusiasts. Each page offers a unique blend of fashion-themed mazes and stylish illustrations to color, inspiring creativity and problem-solving skills in children.
Brushstrokes of Inspiration: Four Major Influences in Victor Gilbert’s Artist...KendraJohnson54
Throughout his career, Victor Gilbert was influenced heavily by various factors, the most notable being his upbringing and the artistic movements of his time. A rich tapestry of inspirations appears in Gilbert’s work, ranging from their own experiences to the art movements of that period.
2. 2
Actinium Pharmaceuticals
Disclaimer
The contents of this presentation and the information which you are given at the time of these slides and the presentation have not been approved
by an authorized person within the meaning of the Financial Services and Markets Act 2000 (the “Act”). Reliance on this presentation and its slides
for the purpose of engaging in investment activity may expose an individual to a significant risk of losing all of the property or other assets invested.
This presentation does not constitute or form part of any offer for sale or subscription or solicitation of any offer to buy or subscribe for any
securities in Actinium Pharmaceuticals, Inc. (“ATNM” or the “Company”) nor shall it or any part of it form the basis of or be relied on in
connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in
these slides or presentation and/or opinions therein. These slides and the presentation are exempt from the general restriction (in section 21 of the
Act) on the communication of invitations or inducements to engage in investment activity on the grounds that it is made to: (a) persons who have
professional experience in matters relating to investments who fall within Article 19(1) of the Financial Services and Markets Act 2000 (Financial
Promotion) Order 2005 (the “Order”); or (b) high net worth entities and other persons to whom it may otherwise lawfully be communicated, falling
within Article 49(1) of the Order (all such persons together being referred to as “relevant persons”). Any person who is not a relevant person should
not rely on this presentation or any of its contents and all persons (whether relevant persons or otherwise) are recommended to seek their own
independent financial advice from a person authorized for the purposes of the Act before engaging in any investment activity involving the
Company’s securities.
Safe Harbor Statement
This presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the private securities litigation
reform act of 1995. Investors and prospective investors are cautioned that any such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties, and that actual results may differ than those projected. Such forward-looking information and
statements are based on the current estimates and projections of the Company or assumptions based on information currently available to the
Company. Such statements involve known and unknown risks, including but not limited to those risks identified in our filings with the Securities
and Exchange Commission, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results
expressed or implied by such statements, including changes from anticipated levels of revenues, future national or regional economic and
competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base,
fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations
reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The
Company has no obligation to update the forward-looking information contained in this presentation. Any forward-looking statements or
information in this presentation speak only as at the date of this presentation.
Disclaimer and Safe Harbor Statement
3. 3
Actinium Pharmaceuticals
Company Description
A public biotechnology company using world
class science to develop and commercialize
antibody directed radioisotopes to target
unmet medical needs in cancer.
4. 4
Actinium Pharmaceuticals
Company Overview
Two development stage targeted antibodies:
Iomab-B expected to enter its single pivotal Phase III study mid-2015 as a
conditioning agent in elderly relapsed/refractory Acute Myeloid Leukemia
(AML) patients prior to bone marrow transplant (BMT)
Actimab-A in ongoing Phase I/II study in elderly, untreated AML patients
We believe as potential breakthrough therapies, Iomab-B and Actimab-A may
achieve successful market penetration given the strong KOL support and
significant unmet medical need
Proprietary Alpha Particle Immunotherapy (APIT) platform poised to deliver
multiple cancer drugs with blockbuster potential
Expert team possessing the vision and desire to enhance shareholder value
Positioned to benefit from increased market recognition of targeted payload
therapies and an initial high-value, niche product model
5. 5
Actinium Pharmaceuticals
Antibody Approaches Targeting Cancer Cells
α
β
Payload Approaches
Company
α - emitters
Actinium Pharmaceuticals
Algeta - Acquired by Bayer
β - emitters
GlaxoSmithKline
Spectrum Pharmaceuticals
Immunomedics
Peregrine Pharmaceuticals
Toxins
Pfizer
Seattle Genetics
Immunogen
Celldex Therapeutics
Progenics
Cancer Treatment Options
Treatment % 50% <10%
Pharmaceutical
Revenue %
<3% ~30%
Always a pharmaceutical
Strong IP protection
Mostly proprietary
Monoclonal Antibodies (mAbs)Radiation
External radiation majority treatment
Internal radiation has mostly no IP
Commoditized
♦
♦
♦
♦
♦
♦
Opportunity
α
Cancer cell
β
Range: .06 mm
Energy: 4-8 MeV
Range: 1-10 mm
Energy: 0.2-2.0 MeV
DNA
6. 6
Actinium Pharmaceuticals
Key Achievements in 2014
Listed on the NYSE Markets - Provides Greater Access to Shareholders and
Liquidity
Addition to the Russell® Indexes and Greater Trading Volume
Attracted Additional Research Analyst Coverage
Strengthened Company Infrastructure with Key Executive Hires
Advancement of Iomab™-B towards Phase 3 Clinical Trial
Progression of Actimab-A Phase 1/2 Program; Announce Interim Results
7. 7
Actinium Pharmaceuticals
Product Pipeline
1. BMT or HSCT (Hematopoietic Stem Cell Transplantation) is a procedure in which cells capable of reconstituting normal bone marrow function are transplanted to
a patient. Iomab-B is expected to enter a Phase III study in mid-2015 for hematopoietic stem cell transplantation in older subjects with active refractory AML.
2. ATNM has decided to discontinue development of Bismab-A at this time due to supply, logistics and cost reasons. Actimab-A is the second generation drug of
Bismab-A.
Development Status
Drug Target Indication R & D Preclin. Phase 1 Phase 2 Phase 3
Iomab-B CD45 BMT1 (Bone Marrow
Transplant)
Bismab-A2 CD33 AML
Actimab-A (s.d.) CD33 AML
Actimab-A (f.d.) CD33 AML
Third Program Undisclosed Undisclosed
Actimab-C Undisclosed Colon Cancer
Actimab-P Undisclosed Prostate Cancer
Actimab-Br Undisclosed Brain Cancer
s.d. – single dose
f.d. – fractionated dose
HuM 195 –
Alpha
Program
8. 8
Actinium Pharmaceuticals
Market Positioning for Iomab-B and Actimab-A
Treatment Response TreatmentsDiagnosis
AML
Age >55
Complete
Response
Relapsed &
Refractory
AML
BMT
Death
High dose
chemotherapy
Actimab-A
Complete
Response
Death
Reduced Intensity
BM Conditioning
Reduced Intensity
BM Conditioning
Iomab-B
Negative Response
ATNM Pipeline Drugs
Positive Response
Current Treatments
ATNM products target both treatment stages for AML patients over 55 years of age
9. 9
Actinium Pharmaceuticals
♦ Blockbuster therapy potential for BMT conditioning especially for elderly, very
sick patients with few curative treatment options
– Initial intended indication is relapsed, refractory AML patients over 55 years old
♦ Compelling clinical data from proof of concept trial in elderly refractory and
relapsed Acute Myeloid Leukemia
– Large safety database: experience with 250+ patients in 5 Phase I and II clinical trials
– Antibody in-licensed from Fred Hutchinson Cancer Research Center
– 7 ongoing physician trials with BC8 mAb, the antibody used in Iomab-B, for other
indications
♦ Safety and efficacy data to date indicate that Iomab-B can potentially disrupt the
field of BMT
♦ Trials results and implied medical benefits have attracted significant interest and
involvement from leading physicians
Iomab-B Overview
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Actinium Pharmaceuticals
Current BMT Conditioning Approach
Iomab-B Regimen
Iomab-B Treatment
Potentially faster pathway to a bone marrow transplant with fewer side effects
Chemotherapy1
RIC BMT
RIC4 BMT
Iomab-B
6 Days 4 Days
28-42 Days 4 Days
1. Chemotherapy include MEC, FLAG-IDA, high-dose cytarabine, among others. Cost is for one or two rounds of inpatient chemotherapy treatment.
2. Transplant procedural costs include 30 day pre-procedure costs (RIC, donor cell procurement, fees, hospital costs, drug costs) and excludes chemotherapy.
3. Includes various associated costs during 180 days post-procedure, including immunosuppressive therapy.
4. RIC, reduced intensity conditioning, is a lower-dose (and therefore less toxic) treatment regimen which helps to facilitate BMT, particularly in older patients.
Sources: Milliman U.S. Organ and Tissue Transplant Cost Estimates and Discussion; Overall Economic Burden of Total Treatment Costs in AML throughout the
Course of the Disease (Mahmoud); Company estimates.
Post
Cost: $50,000-$100,0001 $522,0002 $283,0003
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Actinium Pharmaceuticals
♦ Non-relapse mortality (NRM):
– Day 100: 10%
– Overall: 20% (NRM = 46% in comparable patients
with myeloablative conditioning)
♦ Transplant related mortality: 14% (same as reduced intensity
conditioning)
All relapsed/refractory AML patients over 50 Rel/ref AML patients over 50 w/ poor cytogenetics
♦ Complete response rate: 100%
♦ Engraftment by day 28: 100%
Iomab-B Phase I/II Results
Compelling clinical results enable pivotal Phase III trial
N = Number of patients treated
Iomab-B results from FHCRC clinical trials; Current BMT and Chemotherapy results from MD Anderson outcomes analysis
Sources: Blood 2009 114:5444-5453; unpublished FHCRC data
30%
19%
10%
0%
10%
0%
0%
5%
10%
15%
20%
25%
30%
35%
1 year 2 years
PercentageSurvival
Iomab-B BMT (N=27)
Current BMT (N=10)
Chemotherapy (N=61)
33%
16%
3%
0%
3%
0%
0%
5%
10%
15%
20%
25%
30%
35%
1 year 2 years
PercentageSurvival
Iomab-B BMT (N=18)
Current BMT (N=19)
Chemotherapy (N=95)
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Actinium Pharmaceuticals
Bone Marrow Transplant Market Opportunity
Sources: Healthcare Cost and Utilization Project, AHRQ; US Dept. of HHS; CIBMTR (Preliminary review of information submitted to the CIBMTR)
HSCT Fastest Growing Hospital Procedure
Top 10
Centers =
30% of
procedures
Currently no approved treatments for Iomab-B targeted patients
implies blockbuster potential
Indication* 2014 2015E 2016E 2017E 2018E
Market
Potential
AML $750
MDS $300
ALL $250
NHL/HL $1,500
MM $1,300
Total $4,100
III
Anticipated
Launch
Anticipated Approval
IIIII
II III
III III
III III
Phase I and Phase II represent physician trials at Fred Hutchison Cancer Research Center. Phase III trials represent ATNM sponsorship.
Timelines are projections and the Company makes no representation as to their ability to meet these timelines.
Sources: “Current Uses and Outcomes of Hematopoietic Stem Cell Transplantation 2010”, CIMBTR Summary Slides;
“Trade, foreign policy, diplomacy and health: Pharmaceutical Industry”, WHO website, http://www.who.int/trade/glossry/story073/en/;
“Hematopoietic stem cell transplantation A Global Perspective”, NIH Public Access, JAMA 2010; Company Estimates
13. 13
Actinium Pharmaceuticals
-100%
-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
ChangeinBoneMarrowBlasts
Target: ♦ AML ♦ AML
Effectiveness: ♦ Proof of concept in humans + 500x more potent than Bismab-A
Clinical Stage: ♦ Promising results in Phase II ♦ Currently in a Phase I/II Trial
Supply Chain: ♦ Complex, high COGS + Simple, 10x lower COGS
Ease of Use: ♦ Complex on site preparation + Central manufacturing
HuM 195-Alpha Platform
Bismab-A Profile Actimab-A Advantages
1st Generation 2nd Generation
Second generation Actimab-A 500x more potent than Bismab-A
Bismab-A vs. Actimab-A Monotherapy
Actimab-A efficacy superior to Bismab-A
* Median survival 7.6 mo. vs 1.7 mo. historically for untreated. Each bar equals an individual patient response.
Sources: Clin Cancer Res. 2010, 16(21):5303-5311; Jurcic JG et al. Blood (ASH Meeting Abstracts) 2012, 118:768; Company documents
0.5 mCi/kg
0.75 mCi/kg
1 mCi/kg
1.25 mCi/kg
223%
Bismab-A + Cytoreduction
Median survival 4x greater than historical data*
Parameter Bismab-A Actimab-A
Peripheral blast
elimination
27% 67%
Bone marrow blasts
decrease ≥50%
28% 53%
Bone marrow blasts
≤5% post treatment
0% 20%
High-risk AML: Newly diagnosed, Relapsed/Refractory Patients Relapsed/Refractory Patients only
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Actinium Pharmaceuticals
♦ Phase I/II clinical trial ongoing at world-class treatment centers
– Memorial Sloan Kettering, MD Anderson, Johns Hopkins, Columbia University, University
of Pennsylvania, Fred Hutchinson, Baylor Sammons Cancer Center
♦ New protocol sets lower standard than first Phase I trial
– Treating newly diagnosed patients;
– Introducing cytoreduction which reduces the number of cancer cells
– Fractionated dosing at day one and seven
– New patient population likely to respond better to treatment based on medically accepted
criteria
– No toxicity has been observed to date outside of blood cells at doses expected to be
clinically effective
Actimab-A Multicenter Phase I/II Study
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Actinium Pharmaceuticals
Why Actimab-A Should Play Critical Role in Elderly AML
♦ “Low-Intensity Hypothesis”
─ In patients 65+ intensive chemotherapy is associated with high mortality rate; 2 month mortality ~ 22%1
─ Low intensity treatments are better at extending overall survival in elderly patients even without high CR
rates1
─ Postulates that AML in elderly patients is closer to MDS which informs this line of reasoning2
─ FDA guiding toward overall survival endpoints for frontline treatment of older AML3
♦ Actimab-A is a low intensity product candidate for older AML patients
─ Favorable safety profile in clinical trials to date may allow for use in most patients, unlike high-dose
chemotherapy
─ Results to date are supportive of the “Low-Intensity Hypothesis”
Based on the favorable safety profile in clinical trials to date, Actimab-A
has the potential to be a low intensity therapy for older AML patients
1. Report from 'Great Debates & Updates in Hematology' Conference, Oncology Times 25 January 2009, Volume 31 Issue 2 pp 22-24; Hagop Kantarjian, MD
2. Medscape Oncology CME: Current Treatment of Myelodysplastic Syndrome, 26 June 2008
3. FDA Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, 2007
16. 16
Actinium Pharmaceuticals
Actimab-A Phase I/II Interim Data Highlights
Sources: Phase I Trial of Targeted Alpha-Particle Therapy Using Actinium-225 (225Ac)-Lintuzumab (Anti-CD33) in Combination with Low-Dose Cytarabine (LDAC) for Older
Patients with Untreated Acute Myeloid Leukemia (AML), 56th ASH Annual Meeting and Exposition. Abstract #5293;
Oran B, and Weisdorf DJ, Survival for older patients with acute myeloid leukemia: a population-based study. Haematologica 2012; 97(12):1916-1924.
N Okuyama et al, Prognosis of acute myeloid leukemia transformed from myelodysplastic syndromes: A multicenter retrospective study, Leukemia Research 37 (2013) 862–867.
0
0.2
0.4
0.6
0.8
1
1.2
0 5 10 15 20 25
OverallSurvivalforPrior
MDSPatients
Time in Months
♦ 9.1 month median overall survival in 7 secondary AML patients (range
2.3-24 months)
♦ Compares favorably to 2-5 month expected survival in secondary AML
Improved median survival greatest for secondary AML
-100%
-75%
-50%
-25%
0%
25%
De Novo AML
Secondary AML
ChangeinBoneMarrowBlastCount
Meaningful overall survival benefit, no treatment mortality, lowered blast count
Clear antileukemic effect in most patients
♦ Patients evaluated thus far were high-risk, elderly
─ All nine were greater than 70 years of age (mean: 76, range: 73-81)
─ All but two had secondary AML (antecedent MDS); five had prior treatment with HMA or allogeneic
hematopoietic cell transplantation
─ All had intermediate or poor cytogenetics
♦ No significant drug related safety issues thus far; MTD yet to be established
♦ 5 of 7 (71%) evaluable patients had bone marrow blast reductions
♦ 61% mean reduction in blast count (range 34%-100%)
Each bar represents an individual patient response
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Actinium Pharmaceuticals
Value Drivers
Multiple milestones over the next several years
2014 2015 2016 2017
1H 2H 1H 2H 1H 2H 1H 2H
Iomab-B
–Complete Phase III procotol
–Complete cGMP mAb mfg
–Complete Drug mfg cGMP
–Submit Phase III IND
–Start Phase III, Enrollment Updates
–Topline Phase III Results
–Filing of BLA
–ASCO, ASH updates
Actimab-A
–ASH/Company update
–Complete Phase I trial
–Start Phase II trial
–Enrollment updates/Complete Phase II trial
–Topline Phase II results
–ASH updates
Third Program
–Announce program
–File IND
Strategic
–Licensing
–Collaborations
–Partnering
18. 18
Actinium Pharmaceuticals
Company Overview
Two development stage targeted antibodies:
Iomab-B expected to enter its single pivotal Phase III study mid-2015 as a
conditioning agent in elderly relapsed/refractory Acute Myeloid Leukemia
(AML) patients prior to bone marrow transplant (BMT)
Actimab-A in ongoing Phase I/II study in elderly, untreated AML patients
We believe as potential breakthrough therapies, Iomab-B and Actimab-A may
achieve successful market penetration given the strong KOL support and
significant unmet medical need.
Proprietary Alpha Particle Immunotherapy (APIT) platform poised to deliver
multiple cancer drugs with blockbuster potential
Expert team possessing the vision and desire to enhance shareholder value
Positioned to benefit from increased market recognition of targeted payload
therapies and an initial high-value, niche product model