Tuesday, December 1, 2015

Actinium Submits Iomab-B IND Application to the U.S. FDA

SOURCE: Actinium Pharmaceuticals

Company Gearing Up for Pivotal, Phase 3 Clinical Trial  

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), is a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Iomab-B, a radioimmunotherapeutic that conditions Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant (HSCT), commonly referred to as a Bone Marrow Transplant (BMT). Pending the FDA's acceptance of the IND filing, Actinium will initiate a single, pivotal Phase 3 clinical study in refractory and relapsed AML patients over the age 55.

"We are excited to have submitted the Iomab-B IND application to the FDA," said Kaushik J. Dave, Ph.D., MBA, CEO of Actinium. "We focused heavily on Iomab-B in 2015 and overcame our previous manufacturing hurdles, which gave us great confidence when we met with the FDA for our pre-IND meeting. Our filing, well ahead of our year end guidance, is a great milestone for Actinium."

Sandesh Seth, Actinium's Executive Chairman commented, "This much anticipated regulatory filing is an important one that marks the first step in Actinium's transition to a later development stage biopharmaceutical company. As we prepare for the pivotal Phase 3 clinical trial for Iomab-B in 2016, we have added key members to our executive, regulatory and clinical operations teams and will continue to add selectively. This strengthening of the company will enable us to meet our goals of efficient execution of not only the Iomab-B program but also of the Actimab-A Phase 2 trial planned for early 2016, as well as other pre-clinical and clinical programs expected for next year."

About the Iomab-B Pivotal, Clinical Trial
Iomab-B will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), the fastest growing hospital procedure in the U.S. The Company established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include a single, pivotal Phase 3 clinical study, if it is successful. The population in this two arm, randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year. There are currently no effective treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers, including the Phase 1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.

About Iomab-B
Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Key Executive With Significant Hematology Drug Development Expertise Joins Actinium Pharmaceuticals as Head of Clinical Development

SOURCE: Actinium Pharmaceuticals

Felix Garzon MD, PH.D.: Record of Success Strengthens Team as Company Prepares for the Iomab-B Pivotal Trial

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today the appointment of Felix Garzon, MD, Ph.D. to the position of Senior Vice President, Head of Clinical Development effective August 17, 2015. Dr. Garzon brings with him 28 years of pertinent pharmaceutical and biotechnology experience in increasingly senior roles, most recently at Eisai and Bristol-Myers Squibb, having worked on both later and earlier stages of drug development.

"Felix's deep expertise in hematology and oncology drug development will strengthen the Actinium team in an important way. He brings to Actinium a rigorous track record of successful clinical development in diverse settings including leadership roles with international product teams in large and small companies and in different therapeutic indications," said Kaushik J. Dave, Ph.D., Chief Executive Officer of Actinium Pharmaceuticals. "In addition, Felix has significant clinical trial management and regulatory experience. All of these are key skills as we ramp up our preparations for the upcoming trials for Iomab-B and Actimab-A."

Dragan Cicic, MD, Chief Medical Officer of Actinium added, "Felix is a great addition to our team, whose vast experience in and focus on hematologic oncology will enable us to execute our ambitious programs in a timely and precise manner."

"I am very excited to join the Actinium organization," said Dr. Garzon. "Actinium is pursuing breakthroughs in the field in which I have more than a quarter of a century of professional experience. With two very promising products poised to enter Phase 3 and Phase 2 trials, I am thrilled to have an opportunity to maximize the development prospects for Iomab-B and Actimab-A. As we build and strengthen the clinical team to meet milestones, I look forward to adding value by generating high quality clinical data to help achieve timeline objectives."

Dr. Garzon has more than 28 years of robust international experience working in positions of increasing responsibility in the development of new oncology and hematology drugs in several successful companies in the United States and Europe. He has successfully led and managed the late development and approval of several anticancer drugs, including Halaven®, Trisenox® and Xyotax®. Other roles included Clinical Lead at a Product Creation Unit, Head of Medical Affairs and strategic development plan creation and implementation. Prior to his extensive work in oncology drug development for the pharmaceutical industry, he worked as a scientist in the research of new anti-cancer drugs for several years at the Institute of Toxicology & Chemotherapy of the German Cancer Research Centre, Heidelberg, Germany. Dr. Garzon is the author and co-author of over 80 relevant scientific publications, abstracts and presentations given at international scientific meetings.
Dr. Garzon was previously Senior Director, Oncology Product Creation Unit at Eisai, and Director, Oncology Global Clinical Research at Bristol-Myers Squibb. He also had roles at Chiron, Cell Therapeutics, Rhône-Poulenc Rorer, Pharmacia & Upjohn and Ipsen, following academic appointments and education in Germany, France and Argentina.

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
 

Actinium Files a Provisional Patent Application for Infusion Administration of Iomab-B

SOURCE: Actinium Pharmaceuticals

Filing Enhances Company's Extensive Patent Portfolio

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that it filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for infusion administration of Iomab-B.

A provisional patent application is a legal document that establishes an early priority date for the benefit of claiming "first to file" status against other companies or individuals that may want to file a subsequent patent with similar claims.

"This latest application is a valuable addition to our intellectual property portfolio," said Kaushik J. Dave, President and CEO of Actinium Pharmaceuticals. "It allows us to further secure our leadership position in this highly specialized field."

The Company has a broad intellectual property portfolio that includes 39 issued and pending patents.

About Iomab-B
Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
 

Actinium Announces Closing of $5 Million Registered Direct Offering of Common Stock

SOURCE: Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. ("Actinium" or the "Company") (NYSE MKT: ATNM), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today the closing of its previously announced registered direct offering of $5.0 million of its common stock. Under the terms of the subscription agreements, the Company issued an aggregate of 1,923,078 shares of the Company's common stock at a purchase price of $2.60 per share. This financing was led by investor Dr. Phillip Frost.

Actinium anticipates using the net proceeds for general corporate purposes, including capital expenditures, the advancement of our product candidates in clinical trials, such as Iomab™-B and Actimab-A, preclinical trials, to support licensing activities, and to meet working capital needs.
Laidlaw & Company (UK) Ltd. acted as the sole placement agent with respect to the offering.
The securities were offered pursuant to the Company's effective shelf registration statement previously filed with the Securities and Exchange Commission on Form S-3. A prospectus supplement relating to the offering is filed with the SEC and will be available free of charge on the SEC's website at www.sec.gov. Copies of the final prospectus relating to the offering may be obtained from Laidlaw & Company (UK) Ltd. 546 Fifth Avenue, New York, NY 10036, Attn: Syndicate Department, telephone: 212-953-4900, email: syndicate@laidlawltd.com, or from the above-mentioned SEC website.

This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical Iomab-B will be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is preparing a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Key Opinion Leaders Highlighted Iomab-B's Future in Bone Marrow Transplant; Event Video Posted

SOURCE: Actinium Pharmaceuticals

Hillard Lazarus, MD, Pioneer Transplanter and Roland Turck, MD, Radiopharmaceutical Commercialization Veteran Detailed Unmet Medical Need and Development Path for Iomab-B

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, recently hosted a Key Opinion Leader (KOL) Breakfast for healthcare investors and industry professionals at the NY Palace Hotel. A complete video of this event, as well as brief highlights from the presentations are available and posted for viewing at http://www.actiniumpharma.com/investors/media-content/.

The panelists discussed the dire need for new therapies for older patients with hematologic malignancies including acute myeloid leukemia (AML), and the curative role of bone marrow transplant. Iomab-B was described as having efficacy and safety superior to that of traditional myeloablative regimens, and likely to markedly increase the number of patients eligible for transplant. An update on the upcoming Phase 3 clinical trial of Iomab-B, plus clinical positioning and positive commercial prospects were also provided, and can be viewed online.

The meeting featured bone marrow transplant and hematology specialist Hillard M. Lazarus, MD, a Professor of Medicine at Case Western Reserve University (CWRU) School of Medicine, as well as Disease Team Leader and Director of Novel Cell Therapy at University Hospitals, Case Medical Center, and Company Scientific Advisory Board Member. Also featured was radiopharmaceutical industry veteran Roland U. Turck, MD, Managing Partner at TurckBio and recently-appointed Senior Advisor to the Actinium Board of Directors. Dr. Turck has extensive, unparalleled experience in the launch and commercialization of radiopharmaceuticals.

Dr. Lazarus performed the first bone marrow transplant in Ohio in 1976, and has had a seminal impact on multiple aspects of transplantation He now heads several clinical trials at the National Center for Regenerative Medicine (CWRU). He has over 500 publications and has won a variety of lifetime achievement, distinguished alumnus, and cancer research awards, in addition to fellowships sponsored by the Leukemia Society of America and the American Cancer Society.

Dr. Turck was formerly the head of Bayer's Global Specialty Medicine business, where he helped lead the commercialization of Xofigo, the first alpha particle-emitting radioactive agent, whose launch has been the most commercially successful of any radiopharmaceutical product to date. He is an expert in biopharmaceutical specialty medicine with more than 20 years of pharmaceutical industry experience at Bayer, Berlex, and Schering, having developed and commercialized several major oncology products on a global scale, including Xofigo, Stivarga, Nexavar, and Campath.
Those interested in learning more about Iomab-B or bone marrow transplantation are encouraged to view filmed highlights, or the full-length video of the presentations, which are available in the media section of the Company's website, at http://www.actiniumpharma.com/investors/media-content/.

About Bone Marrow Transplant:Bone marrow transplants (BMT) are most commonly used to treat leukemia and lymphoma, conditions incurred when a blood or immune cell, respectively, becomes cancerous and proliferates. Together, these diseases account for some 50,000 to 75,000 new cases annually in the United States. BMT involves first clearing a patient's body of his or her own immune cells and then transplanting bone marrow, the source of all blood- and immune-forming cells, from a tissue-matched donor. The new cells, which are free of cancer, repopulate the patient's bone marrow and eventually give rise to a functioning set of blood and immune cells, providing a lifelong cure. BMT offers the chance of a "curative" outcome (2+ year survival), and therefore can play a central role in the treatment of AML. The impact of BMT on AML continues to increase with AML being the most common and fastest growing indication for allogeneic BMT, comprising 25% to 30% of all BMT recipients. There are currently over 100,000 BMT survivors across all indications and this number is expected to increase to 250,000 by 2020 and 500,000 by 2030, with 25% of them over age 60.

About Iomab-BIomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

About Actinium PharmaceuticalsActinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
 

Actinium to Host Key Opinion Leader Event Focused on Bone Marrow Transplant, Potential Role of Iomab-B on May 12

Source:  Actinium Pharmaceuticals

Hillard Lazarus MD, Professor of Medicine at Case Western Reserve University and Roland Turck MD, Radiopharmaceutical Veteran With Extensive Drug Commercialization Experience to Be Featured Speakers

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that it will host a Key Opinion Leader (KOL) Breakfast on Tuesday, May 12th, 2015 from 8:00 to 9:30 am Eastern Time at the NY Palace Hotel (455 Madison Ave, Kennedy 1 Room, 4th Floor). This event will be webcast during that time at http://lifesci.rampard.com/20150512.

The meeting will feature bone marrow transplant and hematology specialist Hillard M. Lazarus, MD, a Professor of Medicine at Case Western Reserve University (CWRU) School of Medicine, as well as Disease Team Leader and Director of Novel Cell Therapy at University Hospitals, Case Medical Center, and Company Scientific Advisory Board Member. Also featured is radiopharmaceutical industry veteran Roland U. Turck, MD, Managing Partner at TurckBio and recently-appointed Senior Advisor to the Actinium Board of Directors. Dr. Turck has extensive, unparalleled experience in the launch and commercialization of radiopharmaceuticals.

Dr. Lazarus performed the first bone marrow transplant in Ohio in 1976. His seminal impact in multiple aspects of transplantation was recognized in 1986 with an invitation to develop and chair the Blood and Marrow Transplant Committee of the National Cancer Institute, a position he held until 2003. He now heads several clinical trials at the National Center for Regenerative Medicine (CWRU). He has over 500 publications and has won a variety of lifetime achievement, distinguished alumnus, and cancer research awards, in addition to fellowships sponsored by the Leukemia Society of America and the American Cancer Society.

Dr. Turck was formerly the head of Bayer's Global Specialty Medicine business, where he helped lead the commercialization of Xofigo, the first alpha particle-emitting radioactive agent, whose launch has been the most commercially successful of any radiopharmaceutical product to date. He is an expert in biopharmaceutical specialty medicine with more than 20 years of pharmaceutical industry experience at Bayer, Berlex, and Schering. He boasts an extensive track record of developing and commercializing several major oncology products on a global scale, including Xofigo, Stivarga, Nexavar, and Campath.

Attendance at the event is intended for institutional investors, sell-side analysts, and investment bankers. If you wish to attend in person, please RSVP in advance as space is limited, by contacting LifeSci Advisors at mac@lifesciadvisors.com. A live webcast and subsequent replay of the event will be available at http://lifesci.rampard.com/20150512 for all interested parties. If you would like to ask a question during the live Q&A, please email your request to questions@lifesciadvisors.com.
About Bone Marrow Transplant:

Bone marrow transplants (BMT) are most commonly used to treat leukemia and lymphoma, conditions incurred when a blood or immune cell, respectively, becomes cancerous and proliferates. Together, these diseases account for some 50,000 to 75,000 new cases annually in the United States. BMT involves first clearing a patient's body of his or her own immune cells and then transplanting bone marrow, the source of all blood- and immune-forming cells, from a tissue-matched donor. The new cells, which are free of cancer, repopulate the patient's bone marrow and eventually give rise to a functioning set of blood and immune cells, providing a lifelong cure. BMT offers the chance of a "curative" outcome (2+ year survival), and therefore can play a central role in the treatment of AML. The impact of BMT on AML continues to increase with AML being the most common and fastest growing indication for allogeneic BMT, comprising 25% to 30% of all BMT recipients. There are currently over 100,000 BMT survivors across all indications and this number is expected to increase to 250,000 by 2020 and 500,000 by 2030, with 25% of them over age 60.

About Iomab-B
Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

About Actimab-A
Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. Based on Actinium's alpha-particle immunotherapy (APIT) platform, Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload. Actimab-A has attracted support from leading experts at the prestigious and high-volume cancer treatment hospitals due to the potential of its safety and efficacy profile, as well as its potential potency, specificity and ease of use. Clinical trials are being conducted at world-class cancer institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins Medicine, Columbia University Medical Center, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, and the Texas Oncology-Baylor Charles A. Sammons Cancer Center. Actimab candidates are in early development for other cancers.

About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium's targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company's lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company's second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Thursday, October 22, 2015

Amedica Launches Innovative Articulating Inserter for Minimally Invasive TLIF Procedures

http://www.amedica.com

Source:  Amedica Corporation

Scorpion(TM) Articulating Inserter Improves Visibility and Access While Reducing Impact on Patient


Amedica Corporation (AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce the release of its Scorpion™ articulating inserter to accompany the Valeo II™ TL interbody fusion device system. The Scorpion inserter will be commercially available mid-November 2015, and will aide in minimally-invasive transforaminal lumbar interbody fusion surgeries.

Scorpion™ articulating inserter

“The TLIF approach can be particularly complex, requiring superior surgeon expertise and precision," said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. "This articulating inserter, used with our Valeo II TL and Valeo II TL Round systems, offers greater control and placement accuracy for our silicon nitride interbody fusion device while performing this minimally-invasive technique. The release of Scorpion demonstrates our determination to enhance patient care through our proprietary material and innovative surgical solutions."

The Valeo II TL and Valeo II TL Round are made of micro composite silicon nitride biomaterial, which offers a favorable environment for bone growth and osteointegration, when compared to competitive PEEK and titanium offerings. Valeo II silicon nitride interbody fusion devices are also semi-radiolucent with clearly visible boundaries in x-rays and produce no artifacts under MRI or CT scans. The combination of these properties is found only in Amedica's silicon nitride biomaterial technology.
                                            
The Valeo II TL is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autograft to facilitate fusion. Additional information about Amedica's complete line of products can be found at www.amedica.com.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing private label and OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Amedica Breaks Into the Dental Market With Recent Joint Development Agreement

http://www.amedica.com
Source:  Amedica Corporation

Marks First Step for Silicon Nitride to be Used in a Variety of Medical Applications


Amedica Corporation (AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce that it has entered into a joint development agreement with Worthington dental technology to provide access to the Company’s silicon nitride technology platform to develop, prototype and manufacture the patented Worthington dental implant system.

Pursuant to the terms of the agreement, Amedica will assist Worthington in the development and commercialization of the Worthington dental implant system and devices.  Additionally, Amedica has engaged Worthington as a dental expert to support Amedica in its efforts to expand the use of silicon nitride to additional original equipment manufacturer dental partners.

“The agreement underscores Amedica’s continued focus to provide superior and innovative solutions to the market," said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. "This newest alliance validates the advantages of our proprietary silicon nitride material across a variety of biomedical applications. We look forward to leveraging Worthington’s unique intellectual property to develop and commercialize dental devices that may incorporate the benefits of silicon nitride. We remain committed to offering our customers a biomaterial platform that contains distinct anti-infective and osteopromotive properties to improve the efficacy of clinical outcomes, resulting in enhanced patient care."

Amedica's micro-composite silicon nitride biomaterial is a breakthrough ceramic containing potential anti-bacterial and favorable bone growth properties. Its surface texture and hydrophilic nature attract both osteoblasts and physiologic proteins to ensure reliable osteointegration, while its surface biochemistry inhibits bacterial biofilm adhesion. This combination of optimal material properties is unique to Amedica's silicon nitride material platform.

“We’re excited for the prospect to develop and commercialize this uniquely differentiated biomaterial for our partners and customers,” said Dr. William B. Worthington, inventor of Worthington dental technology. “We believe this novel biomaterial will not only improve patient outcomes, but also provides us with additional innovative device opportunities as we seek to commercialize our dental technology portfolio.”

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing private label and OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.


Amedica Corporation Adds Giuseppe Pezzotti, PhD to Its Scientific Advisory Board

http://www.amedica.com
Source:  Amedica Corporation

Dr. Pezzotti to Present Webcast on September 15, 2015 Highlighting Silicon Nitride Technology


Amedica Corporation (AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced the appointment of internationally renowned scientist Giuseppe Pezzotti, Ph.D. to its Scientific Advisory Board. Dr. Pezzotti will advise the Company on the scientific properties and clinical applications of silicon nitride, and assist Amedica in further developing its technology.

“As a highly-differentiated biomaterials company focused on silicon nitride, Amedica is delighted to welcome Dr. Pezzotti and share his passion and expertise in biomaterials science,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “The addition of Dr. Pezzotti to our Scientific Advisory Board will consolidate our niche in silicon nitride technology, and promote innovation, differentiation, and further development of a unique biomaterial platform. Professor Pezzotti’s previous work on silicon nitride has recently led to new insights into the surface nanostructure of silicon nitride, and why the material is so conducive toward bone cell proliferation, hydroxyapatite growth, possesses superior fracture toughness, and other attractive properties, when compared to other biomaterials used in skeletal reconstruction today. As the limitations of currently available biomaterials used in skeletal reconstruction are increasingly recognized, Amedica is positioned to offer the next generation of practical solutions to surgeons worldwide.”

“I look forward to working with Amedica to provide further validation of the uniqueness of silicon nitride as a biomaterial,” said Dr. Pezzotti, Director of the Ceramic Physics Laboratory and Professor in the Department of Chemistry and Materials Engineering at the Kyoto Institute of Technology. “The webcast next week will be the first of a series of public communications which will explain the foundations of Amedica’s scientific and commercial efforts. These activities will foster a worldwide network of collaborating universities, research centers, and private laboratories, to disseminate knowledge of silicon nitride bioceramics as the successor biomaterial to the legacy plastics, metals, and oxide ceramics used today.”

About Dr. Pezzotti
Giuseppe Pezzotti graduated summa cum laude from Rome University La Sapienza, Italy, and holds three doctoral degrees in Materials Engineering (Osaka University), Solid State Physics (Kyoto University), and Medical Sciences (Tokyo Medical University), all obtained in Japan, the country where he has lived for the past 28 years. From 2002 to 2012, Professor Pezzotti served as the director of the Research Institute for Nanoscience at the Kyoto Institute of Technology. Since 2005, he has been an adjunct professor at the Department of Orthopaedic Research at Loma Linda University, Loma Linda, CA. In 2009, he was honored with an invited professorship from the Department of Medical Engineering at Osaka University, and since 2010 has been a visiting professor in the Department of Molecular Cell Physiology at the Kyoto Prefectural University of Medicine. Professor Pezzotti has published about 570 scientific papers, 1 book as a single author, 13 book chapters, and holds 8 patents, including a world patent regarding nanoscale stress microscopy in the scanning electron microscope. He has licensed his intellectual properties to more than 20 major industrial firms around the world and has served as their consultant. His book entitled “Advanced Materials for Joint Implants” (published in 2013) has quickly become a landmark for scientists and medical doctors working in the field of joint arthroplasty. Among several international awards in 2013, Professor Pezzotti became a Fellow of the Academy of Science of the Bologna Institute in appreciation of his advanced Raman spectroscopic studies linking quantum mechanics to medical sciences. His research interests include micro- and nano-mechanics of biomaterials, with particular interest in the development of new spectroscopic techniques for quantitatively assessing wear degradation of artificial joints, stress distributions in bones, and synthetic hydroxyapatites.

Conference Call
The Company will hold a conference call and webcast to discuss the scientific and technical support on the physics, chemistry, and mechanical behavior of silicon nitride as a biomaterial in comparison with other biomaterials on September 15, 2015 at 6:30 p.m. Eastern Time. The Company invites all interested parties to join the call by dialing (855) 455-6055, any time after 6:20 p.m. Eastern Time on September 15th. The Conference ID number is 22966141. International callers should dial (484) 756-4308. A live audio webcast and replay of the call will be available through a link on the Company's web site, at http://investors.amedica.com/events.cfm

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Amedica Enters Into Definitive Agreements to Raise $15.0 Million in Equity Financing

http://www.amedica.com


Source:  Amedica Corporation

Amedica Corporation (AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has entered into definitive agreements with institutional investors to raise up to $15.0 million in a concurrent registered direct offering of common stock and Series B Warrants and private placement of Series A Warrants and Series C Warrants.

As part of this transaction, the Company has entered into a settlement agreement with MG Partners II, Ltd. (“Magna”) as well as amended its loan agreements with Hercules Technology Growth Capital, Inc. (“Hercules”). The settlement agreement with Magna provides for the withdrawal of a previously issued default notice and permanent waivers of any contractual rights, including but not limited to any convertible features associated with Magna’s convertible debentures.  As part of the Hercules amended loan agreement, Hercules has also withdrawn its previously issued default notice and agreed to reduce the Company’s financial cash covenant as the loan is paid, which should provide for additional financial flexibility in the future.

This transaction is expected to execute in three equal tranches. The first tranche is a registered direct offering of 13,123,360 shares of common stock and Series B Warrants to purchase 13,123,360 shares of common stock for a price of $0.381 per share of Common Stock and Series B Warrant. The Series B Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The first tranche also includes a concurrent private placement of Series A Warrants and Series C Warrants, each to purchase 13,123,360 shares of common stock.  The Series A Warrants have an exercise price of $0.47 and shall be exercisable for a period of 5.5 years.  The Series C Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The Company expects to receive proceeds of approximately $5.0 Million from this first tranche, which is expected to close on September 11, 2015.  The exercise of both the Series B Warrants and the Series C Warrants may occur automatically under certain conditions and is subject to shareholder approval.  The number of shares issuable upon the exercise of the Series A Warrants, Series B Warrants and Series C Warrants may increase under certain circumstances. The second and third tranches of the transaction is the exercise of the Series B Warrants and Series C Warrants for an additional $10.0 million. For further information on the transaction, please review the transaction documents filed today with the Company’s Current Report on Form 8-K.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (LTS), is acting as exclusive placement agent in connection with the transaction.

The shares of common stock and Series B Warrants are being offered by Amedica pursuant to a shelf registration statement on Form S-3 (file no. 333-205545) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.

About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has entered into definitive agreements with institutional investors to raise up to $15.0 million in a concurrent registered direct offering of common stock and Series B Warrants and private placement of Series A Warrants and Series C Warrants.
As part of this transaction, the Company has entered into a settlement agreement with MG Partners II, Ltd. (“Magna”) as well as amended its loan agreements with Hercules Technology Growth Capital, Inc. (“Hercules”). The settlement agreement with Magna provides for the withdrawal of a previously issued default notice and permanent waivers of any contractual rights, including but not limited to any convertible features associated with Magna’s convertible debentures.  As part of the Hercules amended loan agreement, Hercules has also withdrawn its previously issued default notice and agreed to reduce the Company’s financial cash covenant as the loan is paid, which should provide for additional financial flexibility in the future.
This transaction is expected to execute in three equal tranches. The first tranche is a registered direct offering of 13,123,360 shares of common stock and Series B Warrants to purchase 13,123,360 shares of common stock for a price of $0.381 per share of Common Stock and Series B Warrant. The Series B Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The first tranche also includes a concurrent private placement of Series A Warrants and Series C Warrants, each to purchase 13,123,360 shares of common stock.  The Series A Warrants have an exercise price of $0.47 and shall be exercisable for a period of 5.5 years.  The Series C Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The Company expects to receive proceeds of approximately $5.0 Million from this first tranche, which is expected to close on September 11, 2015.  The exercise of both the Series B Warrants and the Series C Warrants may occur automatically under certain conditions and is subject to shareholder approval.  The number of shares issuable upon the exercise of the Series A Warrants, Series B Warrants and Series C Warrants may increase under certain circumstances. The second and third tranches of the transaction is the exercise of the Series B Warrants and Series C Warrants for an additional $10.0 million. For further information on the transaction, please review the transaction documents filed today with the Company’s Current Report on Form 8-K.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSEMKT:LTS), is acting as exclusive placement agent in connection with the transaction.
The shares of common stock and Series B Warrants are being offered by Amedica pursuant to a shelf registration statement on Form S-3 (file no. 333-205545) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.
- See more at: http://globenewswire.com/news-release/2015/09/08/766672/0/en/Amedica-Enters-Into-Definitive-Agreements-to-Raise-15-0-Million-in-Equity-Financing.html#sthash.w0954zP1.dpuf
Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has entered into definitive agreements with institutional investors to raise up to $15.0 million in a concurrent registered direct offering of common stock and Series B Warrants and private placement of Series A Warrants and Series C Warrants.
As part of this transaction, the Company has entered into a settlement agreement with MG Partners II, Ltd. (“Magna”) as well as amended its loan agreements with Hercules Technology Growth Capital, Inc. (“Hercules”). The settlement agreement with Magna provides for the withdrawal of a previously issued default notice and permanent waivers of any contractual rights, including but not limited to any convertible features associated with Magna’s convertible debentures.  As part of the Hercules amended loan agreement, Hercules has also withdrawn its previously issued default notice and agreed to reduce the Company’s financial cash covenant as the loan is paid, which should provide for additional financial flexibility in the future.
This transaction is expected to execute in three equal tranches. The first tranche is a registered direct offering of 13,123,360 shares of common stock and Series B Warrants to purchase 13,123,360 shares of common stock for a price of $0.381 per share of Common Stock and Series B Warrant. The Series B Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The first tranche also includes a concurrent private placement of Series A Warrants and Series C Warrants, each to purchase 13,123,360 shares of common stock.  The Series A Warrants have an exercise price of $0.47 and shall be exercisable for a period of 5.5 years.  The Series C Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The Company expects to receive proceeds of approximately $5.0 Million from this first tranche, which is expected to close on September 11, 2015.  The exercise of both the Series B Warrants and the Series C Warrants may occur automatically under certain conditions and is subject to shareholder approval.  The number of shares issuable upon the exercise of the Series A Warrants, Series B Warrants and Series C Warrants may increase under certain circumstances. The second and third tranches of the transaction is the exercise of the Series B Warrants and Series C Warrants for an additional $10.0 million. For further information on the transaction, please review the transaction documents filed today with the Company’s Current Report on Form 8-K.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSEMKT:LTS), is acting as exclusive placement agent in connection with the transaction.
The shares of common stock and Series B Warrants are being offered by Amedica pursuant to a shelf registration statement on Form S-3 (file no. 333-205545) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.
- See more at: http://globenewswire.com/news-release/2015/09/08/766672/0/en/Amedica-Enters-Into-Definitive-Agreements-to-Raise-15-0-Million-in-Equity-Financing.html#sthash.w0954zP1.dpuf
Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has entered into definitive agreements with institutional investors to raise up to $15.0 million in a concurrent registered direct offering of common stock and Series B Warrants and private placement of Series A Warrants and Series C Warrants.
As part of this transaction, the Company has entered into a settlement agreement with MG Partners II, Ltd. (“Magna”) as well as amended its loan agreements with Hercules Technology Growth Capital, Inc. (“Hercules”). The settlement agreement with Magna provides for the withdrawal of a previously issued default notice and permanent waivers of any contractual rights, including but not limited to any convertible features associated with Magna’s convertible debentures.  As part of the Hercules amended loan agreement, Hercules has also withdrawn its previously issued default notice and agreed to reduce the Company’s financial cash covenant as the loan is paid, which should provide for additional financial flexibility in the future.
This transaction is expected to execute in three equal tranches. The first tranche is a registered direct offering of 13,123,360 shares of common stock and Series B Warrants to purchase 13,123,360 shares of common stock for a price of $0.381 per share of Common Stock and Series B Warrant. The Series B Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The first tranche also includes a concurrent private placement of Series A Warrants and Series C Warrants, each to purchase 13,123,360 shares of common stock.  The Series A Warrants have an exercise price of $0.47 and shall be exercisable for a period of 5.5 years.  The Series C Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The Company expects to receive proceeds of approximately $5.0 Million from this first tranche, which is expected to close on September 11, 2015.  The exercise of both the Series B Warrants and the Series C Warrants may occur automatically under certain conditions and is subject to shareholder approval.  The number of shares issuable upon the exercise of the Series A Warrants, Series B Warrants and Series C Warrants may increase under certain circumstances. The second and third tranches of the transaction is the exercise of the Series B Warrants and Series C Warrants for an additional $10.0 million. For further information on the transaction, please review the transaction documents filed today with the Company’s Current Report on Form 8-K.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSEMKT:LTS), is acting as exclusive placement agent in connection with the transaction.
The shares of common stock and Series B Warrants are being offered by Amedica pursuant to a shelf registration statement on Form S-3 (file no. 333-205545) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.
- See more at: http://globenewswire.com/news-release/2015/09/08/766672/0/en/Amedica-Enters-Into-Definitive-Agreements-to-Raise-15-0-Million-in-Equity-Financing.html#sthash.w0954zP1.dpuf
Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has entered into definitive agreements with institutional investors to raise up to $15.0 million in a concurrent registered direct offering of common stock and Series B Warrants and private placement of Series A Warrants and Series C Warrants.
As part of this transaction, the Company has entered into a settlement agreement with MG Partners II, Ltd. (“Magna”) as well as amended its loan agreements with Hercules Technology Growth Capital, Inc. (“Hercules”). The settlement agreement with Magna provides for the withdrawal of a previously issued default notice and permanent waivers of any contractual rights, including but not limited to any convertible features associated with Magna’s convertible debentures.  As part of the Hercules amended loan agreement, Hercules has also withdrawn its previously issued default notice and agreed to reduce the Company’s financial cash covenant as the loan is paid, which should provide for additional financial flexibility in the future.
This transaction is expected to execute in three equal tranches. The first tranche is a registered direct offering of 13,123,360 shares of common stock and Series B Warrants to purchase 13,123,360 shares of common stock for a price of $0.381 per share of Common Stock and Series B Warrant. The Series B Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The first tranche also includes a concurrent private placement of Series A Warrants and Series C Warrants, each to purchase 13,123,360 shares of common stock.  The Series A Warrants have an exercise price of $0.47 and shall be exercisable for a period of 5.5 years.  The Series C Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The Company expects to receive proceeds of approximately $5.0 Million from this first tranche, which is expected to close on September 11, 2015.  The exercise of both the Series B Warrants and the Series C Warrants may occur automatically under certain conditions and is subject to shareholder approval.  The number of shares issuable upon the exercise of the Series A Warrants, Series B Warrants and Series C Warrants may increase under certain circumstances. The second and third tranches of the transaction is the exercise of the Series B Warrants and Series C Warrants for an additional $10.0 million. For further information on the transaction, please review the transaction documents filed today with the Company’s Current Report on Form 8-K.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSEMKT:LTS), is acting as exclusive placement agent in connection with the transaction.
The shares of common stock and Series B Warrants are being offered by Amedica pursuant to a shelf registration statement on Form S-3 (file no. 333-205545) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.
- See more at: http://globenewswire.com/news-release/2015/09/08/766672/0/en/Amedica-Enters-Into-Definitive-Agreements-to-Raise-15-0-Million-in-Equity-Financing.html#sthash.w0954zP1.dpuf
Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that it has entered into definitive agreements with institutional investors to raise up to $15.0 million in a concurrent registered direct offering of common stock and Series B Warrants and private placement of Series A Warrants and Series C Warrants.
As part of this transaction, the Company has entered into a settlement agreement with MG Partners II, Ltd. (“Magna”) as well as amended its loan agreements with Hercules Technology Growth Capital, Inc. (“Hercules”). The settlement agreement with Magna provides for the withdrawal of a previously issued default notice and permanent waivers of any contractual rights, including but not limited to any convertible features associated with Magna’s convertible debentures.  As part of the Hercules amended loan agreement, Hercules has also withdrawn its previously issued default notice and agreed to reduce the Company’s financial cash covenant as the loan is paid, which should provide for additional financial flexibility in the future.
This transaction is expected to execute in three equal tranches. The first tranche is a registered direct offering of 13,123,360 shares of common stock and Series B Warrants to purchase 13,123,360 shares of common stock for a price of $0.381 per share of Common Stock and Series B Warrant. The Series B Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The first tranche also includes a concurrent private placement of Series A Warrants and Series C Warrants, each to purchase 13,123,360 shares of common stock.  The Series A Warrants have an exercise price of $0.47 and shall be exercisable for a period of 5.5 years.  The Series C Warrants have an exercise price of $0.47 and shall be exercisable up to December 30, 2015. The Company expects to receive proceeds of approximately $5.0 Million from this first tranche, which is expected to close on September 11, 2015.  The exercise of both the Series B Warrants and the Series C Warrants may occur automatically under certain conditions and is subject to shareholder approval.  The number of shares issuable upon the exercise of the Series A Warrants, Series B Warrants and Series C Warrants may increase under certain circumstances. The second and third tranches of the transaction is the exercise of the Series B Warrants and Series C Warrants for an additional $10.0 million. For further information on the transaction, please review the transaction documents filed today with the Company’s Current Report on Form 8-K.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSEMKT:LTS), is acting as exclusive placement agent in connection with the transaction.
The shares of common stock and Series B Warrants are being offered by Amedica pursuant to a shelf registration statement on Form S-3 (file no. 333-205545) filed pursuant to the Securities Act of 1933, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and, through its partnership with Kyocera, the world's largest ceramic manufacturer. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.
- See more at: http://globenewswire.com/news-release/2015/09/08/766672/0/en/Amedica-Enters-Into-Definitive-Agreements-to-Raise-15-0-Million-in-Equity-Financing.html#sthash.w0954zP1.dpuf

Saturday, July 11, 2015

Phase II Clinical Trial Featuring 22nd Century’s Very Low Nicotine Tobacco Accepted for Publication

Source:  22nd Century Group, Inc.

Very Low Nicotine Cigarettes Reduce Frequency and Urges to Smoke, Help Smokers Quit

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today that an independent Phase II clinical trial conducted at Queen Mary University of London that explored the efficacy of the Company’s proprietary very low nicotine tobacco as a smoking cessation aid when combined with pharmacotherapy has been accepted for publication in Nicotine & Tobacco Research. The study was supported by a grant from the Global Research Awards for Nicotine Dependence (GRAND) funded by Pfizer, Inc.

The results of this study once again confirm the effectiveness of 22nd Century’s very low nicotine tobacco cigarettes as a smoking cessation aid. The Company’s very low nicotine cigarettes satisfy the behavioral aspect of smoking while delivering only trace amounts of nicotine. Indeed, it is 22nd Century’s fundamental assertion that very low nicotine cigarettes uncouple the behavioral/sensory aspects of smoking from the rapid delivery of nicotine.

The Queen Mary researchers noted: “[Very low nicotine cigarettes] have been shown to be satisfying... [and] were also shown to reduce tobacco withdrawal symptoms, including urges to smoke and low mood.” The clinical trial compared the combination of very low nicotine cigarettes together with two other treatments: 1) varenicline (Pfizer’s Chantix), and 2) nicotine replacement therapies (patches, lozenges, etc.). In each case, 22nd Century’s proprietary tobacco cigarettes provided smokers with a substantial boost in their efforts to stop smoking. Despite providing patients with only a 2-week supply of 22nd Century’s very low nicotine cigarettes (a separately published Phase II clinical trial used a 6 week treatment period) researchers found that participants who received very low nicotine cigarettes had higher quit rates at 1-week, 4-weeks, 6-weeks, and at the study’s maximum 12-weeks. However, due to the size of the study, researchers were unable to achieve statistically significant results at 6 and 12 weeks.

Although the study refers to 22nd Century’s cigarettes as “de-nicotinised cigarettes,” or DNCs, 22nd Century does not “de-nicotinise” or chemically strip tobacco to remove the nicotine. Instead, the Company’s proprietary very low nicotine tobacco, when grown and processed in the same manner as conventional tobacco, contains 95% less nicotine.

As the Queen Mary clinical trial was initiated in 2011, researchers used 22nd Century’s first generation very low nicotine tobacco. Accordingly, it is not surprising that these first generation cigarettes were not well suited to British consumer tastes. More recently, 22nd Century has developed very low nicotine tobacco blends designed according to consumer tastes in each of Europe, Asia, and the Americas that the Company believes will be very satisfying to smokers.

The Queen Mary trial highlights one of the important applications of 22nd Century’s proprietary very low nicotine tobacco. Another application of the novel technology is demonstrated by 22nd Century’s MAGIC 0 brand (0.04 mg nicotine yield; a 95% reduction in nicotine) which is the world’s only tobacco cigarette brand to provide smokers with the choice of a product which separates the rapid delivery of nicotine from the act of smoking. Sales of MAGIC 0 brand and MAGIC 2 brand have recently commenced in Europe and will be available in several additional countries by the end of 2015. 22nd Century does not represent that any of its current commercial brands are intended to be used as smoking cessation aids.

The Queen Mary study concludes: “The most pragmatic approach may be to offer an ongoing supply of [very low nicotine cigarettes] to those who want to continue using them.” This conclusion echoes Former US FDA Commissioner Dr. David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.” Indeed, 22nd Century is deeply committed to commercializing this approach and remains the only company in the world capable of producing virtually nicotine-free tobacco.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents and 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Group Obtains Cigarette Distribution Licenses in New York State

Source:  22nd Century Group, Inc.

RED SUN Approval Secured in All 50 States

22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, LLC, has been granted both a New York State Cigarette Stamping Agent license and a New York State Wholesale Cigarette Dealer license. With these licenses, the Company gains the ability to distribute its RED SUN cigarettes across New York State without the need to use a middle-man distributor.

In addition, 22nd Century has secured approval for RED SUN to be sold in all 50 states plus the District of Columbia. Few of the nation’s small, independent cigarette makers – commonly referred to as “microsmokes” – can claim to have such complete coverage. Gaining nationwide approval is especially impressive given that it has been only 10 months since 22nd Century became the first company in more than six years to be approved as a new signatory to the Master Settlement Agreement between the tobacco industry and the 46 Settling States (as a result of the Company’s strategic acquisition of NASCO Products, LLC).

“The New York State Stamping Agent and Wholesale Dealer licenses give us the flexibility to supply New York retail stores directly,” said Karen Delaney, 22nd Century Group’s Tax Compliance Manager. “Though we consider our relationships with other New York distributors very important, by securing our own licenses in New York, we gain control over distribution of our products in a key strategic region for our Company.”

The acquisition of licenses and state directory listings highlights the rapid expansion of RED SUN availability across the United States. After launching RED SUN in January 2015, 22nd Century has grown its retail store count to well over 300, including hundreds of stores specifically listed on its www.redsuncigarettes.com website. Retail stores in the Portland, Oregon region – a part of the Rich & Rhine distribution network – are also coming online quickly and should increase the store count to more than 500. Other distributors, currently ramping up stock and training their sales representatives, could double the RED SUN store count to more than 1,000 retail locations by the end of the third quarter.

“Securing approval for RED SUN in all 50 states is an important milestone for the Company,” remarked Henry Sicignano III, President and Chief Executive Officer. “I am extremely pleased with the rapid growth of our retail network and look forward to achieving 1,000 RED SUN retail stores very soon.”

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents and 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Group Announces Closing of $6 Million Registered Direct Offering

Source:  22nd Century Group, Inc.

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company whose mission is to reduce the harm caused by smoking, announced today that it has closed the previously announced registered direct offering of common stock and warrants consisting of 6,000,000 shares of the Company’s common stock and 66-month warrants to purchase 3,000,000 shares of common stock at an exercise price of $1.25 per share (not exercisable for six months from issuance). The stock and warrants were sold for $1.00 per unit. The net proceeds of the offering, excluding any proceeds that may be received from the exercise of warrants, are approximately $5.6 million and will be used for general corporate purposes, including working capital. Chardan Capital Markets, LLC acted as the sole placement agent for this transaction.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents plus an additional 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

22nd Century Group Announces $6 Million Registered Direct Offering

Source:  22nd Century Group, Inc.

22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company whose mission is to reduce the harm caused by smoking, announced today that it has entered into an agreement with a single institutional investor to receive $6 million in gross proceeds in a registered direct offering through the sale of common stock and warrants consisting of 6,000,000 shares of the Company’s common stock and 66-month warrants to purchase 3,000,000 shares of common stock at an exercise price of $1.25 per share (not exercisable for six months from issuance). If the warrants are exercised for cash in full, the Company would receive additional gross proceeds of approximately $3.75 million.

The offering is expected to close on or about June 2, 2015, subject to customary closing conditions. The net proceeds of the financing will be used for general corporate purposes, including working capital. 

Henry Sicignano III, President and Chief Executive Officer of 22nd Century, commented, "We are preparing for an exciting second half of 2015 on multiple fronts. Our key priorities remain the successful launch of RED SUN in the U.S. and MAGIC in Europe; signing agreements with leading distributors in the U.S. and abroad; potential strategic partnerships for X-22, the Company’s novel smoking cessation aid in development; submission of a modified risk tobacco product application with the FDA for very low nicotine Brand A cigarettes; joint venture partnerships in Asia; and the continuation of our world renowned research in tobacco technology." Mr. Sicignano continued, "We believe this capital raise – with a single institutional investor – is a strong vote of confidence in 22nd Century and an important step forward in executing our strategy."

Chardan Capital Markets, LLC acted as the sole placement agent for this transaction.

The securities described above are being offered by 22nd Century through a prospectus supplement pursuant to 22nd Century’s shelf registration statement on Form S-3 as previously filed and declared effective by the Securities and Exchange Commission and the base prospectus contained therein (Registration No. 333-195386). A prospectus supplement related to the offering will be filed with the Securities and Exchange Commission. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities are being be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, by contacting Chardan Capital Markets, LLC, 150 East 58th Street, 28th Floor, New York, NY 10155, at (646) 465-9028, or the Securities and Exchange Commission's website at http://www.sec.gov.

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century owns or exclusively controls 128 issued patents plus an additional 52 pending patent applications in 96 countries. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.