December 1, 2022

ATNM Profile

Actinium Pharmaceuticals, Inc.

OUR NEW PROFILE IS:   (NASDAQ: ATNM)

Can a Flagship Phase III Trial  and Cutting-Edge Phase 1 Trial  Help This Innovator Cure Active, Relapsed, or Refractory Acute Myeloid Leukemia?

Actinium Pharmaceuticals had $116.3 million in cash as of June 30, 2022; that is enough to fund its operations through mid-2025.(28)

Prior study shows that 100% of patients who received Iomab-B were able to go on to receive BMT and engraftment without any type of delay. (28)

Results from phase 1 study using Actimab-A in combination with CLAG-M for the treatment of acute myeloid leukemia patients expected Q4 of 2022.(28)

Actinium Pharmaceuticals had $116.3 million in cash and equivalents as of June 30, 2022; that is enough to fund its operations through mid-2025.(28)

 

Read the INVESTOR PRESENTATION HERE

*****BREAKING NEWS RELEASED THIS MORNING HAVING A MAJOR IMPACT*****

Actinium Announces Positive Top-line Results from Pivotal Phase 3 SIERRA Trial of Iomab-B in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia

–  Iomab-B met the primary endpoint of durable complete remission of 6-months following initial complete remission after HCT with a p-value of <0.0001

NEW YORK, Oct. 31, 2022 /PRNewswire/ — Actinium Pharmaceuticals, Inc.(NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced positive top-line results from the pivotal Phase 3 trial for its lead product candidate Iomab-B. The SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial was conducted in patients 55 years of age or older who had active disease (relapsed or refractory AML). The SIERRA trial is a randomized, multi-center, controlled study which compared Iomab-B as a conditioning regimen prior to a Bone Marrow Transplant (BMT) versus a control arm which allowed all current means of conventional care with the intent to transplant these patients. The SIERRA trial met its primary endpoint of durable complete remission or dCR of 6 months post initial remission after a BMT in Iomab-B arm compared to conventional care arm demonstrating statistical significance p<0.0001.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, added, “We are excited that the randomized, controlled, multi-center, pivotal SIERRA trial has delivered these results for patients that need new treatment options. Our goal is to increase access to BMT and improve patient outcomes with Iomab-B, and these topline results move us in this direction given their statistical significance. We will continue to work on our Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for approval of Iomab-B. On behalf of Actinium, I’d like to thank the patients who took the leap of faith and enrolled in the SIERRA trial, their families and caregivers who supported them and the investigators who contributed their efforts and advice who made this trial possible. Without them it would not have been possible to yield these results that will enable us to continue to develop Iomab-B.”

Sandesh Seth, Actinium’s Chairman and CEO, said, “This is a significant milestone in Actinium’s lifecycle and a testimony to the quality of our team who undertook a pioneering study in a patient population that is considered largely futile to treat. Despite being perennially under-staffed and under resourced, their passion and perseverance has yielded a clinically meaningful dividend. Our recently strengthened team is executing to enable our mission to disrupt the field of bone marrow conditioning with Iomab-B, first in r/r AML and then by building upon its robust prior clinical results in several hematological diseases. We look forward to sharing additional clinical data from the SIERRA trial by year end.”

About Iomab-B and the Pivotal Phase 3 SIERRA Trial 

Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial produced positive topline results, meeting its primary endpoint of durable Complete Remission (dCR) of 6 months with statistical significance (p<0.0001). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037.

The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician’s choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 single agents or combination of agents as no standard of care exists for this patient population. Data from full patient enrollment presented at the Transplantation & Cellular Therapy Tandem Meetings in April 2022 showed that 100% of patients receiving Iomab-B accessed BMT and engrafted without delay. Iomab-B was also shown to be well tolerated given its targeted nature, consistent with its previous clinical data. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs.

Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europerepresents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.

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Hello Everyone,

Biotech stocks can start as little known afterthoughts and turn into explosive disruptors on the cusp of revolutionizing medicine in months, weeks, or even days.

Actinium Pharmaceuticals, Inc. (ATNM) could be a great speculative biotech play to look into. That’s because it is gearing up to report topline results from the phase 3 SIERRA study, which is using Iomab-B as a preconditioning agent in patients over the age of 55 with active relapsed/refractory Acute Myeloid Leukemia (AML) prior to receiving a hematopoietic stem cell transplant (HSCT). The potential for this therapy is huge, because it could provide the capability for more patients to benefit from being able to receive HSCT. (28)

Actinium Pharmaceuticals, Inc. (ATNM) is on track to report results from the phase 3 SIERRA study in Q4 of 2022. In addition to this catalyst, there is another opportunity for market participants to look forward to before the end of this year.

Overall survival data, from the ongoing phase 1 study using Actimab-A in combination with CLAG-M for AML patients, are expected in Q4 of 2022.

The reason why Actimab-A might be an important program to move forward is because it allows the treatment of AML patients to receive radiation at the cellular level, which is not possible with traditional external beam radiation.

Positive results have been obtained with Actimab-A plus CLAG-M and the hope is that this ARC CD33 drug can be used with other agents to improve patient outcomes in hematological malignancies. With proof of concept established with Iomab-B as a conditioning agent for AML, plus a few catalysts expected before the end of 2022, these are the reasons some believe it is a great speculative biotech play to look into. (28)

Meet Actinium Pharmaceuticals (NYSE: ATNM). This clinical-stage biopharmaceutical company could completely revolutionize medicine. All by developing targeted radiotherapies that deliver cancer-killing radiation with cellular-level precision.

Based on recent history, when biotech companies find a solution, the results can be life-changing. Keep a very close eye on this company as its Iomab-B treatment progresses through Phase III SIERRA trials.

That’s why we put together this comprehensive research report on Actinium Pharmaceuticals (NYSE: ATNM), which we’re thrilled to send your way. We’re about to reveal the top 5 reasons to strongly consider this company ASAP.

We have a long track record of finding diamonds in the rough. Actinium Pharmaceuticals (NYSE: ATNM) could be our latest and greatest find.

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There is Demand For a Leukemia Cure…and the Market Looks Lucrative

The leukemia therapeutics market could reach $17.1 billion by 2024 from $12.3 billion in 2019, at a CAGR of 6.8%. (Source 5)

Do you know what’s driving this market? A rising prevalence of acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), and chronic myeloid leukemia (CML). The increasing number of approvals of novel & innovative dr-ugs and immunotherapies is evidence of an increasing need for leukemia therapies. (Source 5)

Say hello to a wide-open opportunity for Actinium Pharmaceuticals (NYSE: ATNM).

Treatment options for AML, or acute myeloid leukemia, is precisely an unmet need- especially for those under 45. According to Eunice Wang, MD, Chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center, as quoted by Check Rare, (Source 6) it is rarely diagnosed in patients under the age of 45.

At the moment, the five-year survival rate for those 20 and older is also putrid 26%. (Source 7)

Some must also contend with relapsed, or recurrent, acute myelogenous leukemia(AML), which means leukemia came back after treatment and after reaching remission. Refractory AML means leukemia did not respond to treatment. Complete remission can’t be achieved because chemotherapy wasn’t able to kill off enough leukemia cells. (Source 8)

Actinium’s Iomab-B Could Be Nearing a Treatment With SIERRA trials

When you want to find a biotech play, you have to think this way- “don’t talk about it, be about it.”

Well, Actinium isn’t just talking the talk, they’re walking the walk.

On September 15, Actinium announced enrollment for its pivotal Phase III SIERRA trial of Iomab-B was complete. (Source 1)

SIERRA is a 150-patient, multicenter, randomized trial studying Iomab-B, an antibody-radiation conjugate comprising an anti-CD45 antibody and radioactive iodine-131 (I-131), compared with salvage chemotherapy inactive, relapsed, or refractory acute myeloid leukemia (AML).

“Iomab-B was developed to address the significant unmet need of patients who could benefit and possibly be cured of their blood cancer with a bone marrow transplant but could not receive a transplant because non-targeted conditioning regimens could not produce a remission or are too toxic in this patient population. We are confident that Iomab-B will squarely address this unmet need given its targeted nature and ability to deliver high amounts of radiation directly to the bone marrow resulting in myeloablation while sparing healthy organs,” said Dr. Avinash Desai, Actinium Pharmaceuticals’ Executive VP, Clinical Development. (Source 9)

The company’s Chief Medical Officer, Avinash Desai said: (Source 17)

“The remarkably consistent and high rates of BMT engraftment together with the low rates of non-relapse transplant-related mortality at day 100 with Iomab-B through 100% enrollment give us great confidence in SIERRA.”

And the company’s press release added more:

– Consistent 5-times greater difference between Iomab-B vs Control arm at each 100-day NR-TRM (non-relapse transplant-related mortality) interim analysis of the SIERRA trial

– Control arm therapies failed to achieve remission in 83% of patients with just 14% of patients being potentially evaluable at 100-day NR-TRM for the primary endpoint compared to 100% BMT engraftment with Iomab-B and 70% of patients potentially evaluable for the primary endpoint

– Unmet need in relapsed and refractory AML demonstrated by 66% of patients enrolled in SIERRA having received and failed targeted therapies prior to enrollment

– Significantly lower rate of sepsis (p=0.002) and lower rates of febrile neutropenia in patients receiving Iomab-B compared to salvage therapy in the control arm

With this info coming out at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH), could it help spark additional interest in Actinium?

In short, if things continue progressing the way they are, Actinium Pharmaceuticals (NYSE:ATNM) could be a game-changer.

The SIERRA Trial is the ONLY Randomized Phase 3 Trial to Offer Bone Marrow Transplants (BMT) (Source 9)

The company’s SIERRA trial for Iomab-B is a 150-patient, randomized 1:1 pivotal Phase 3 trial studying Iomab-B compared to physician’s choice of salvage chemotherapy in patients age 55 and above with active, relapsed, or refractory AML or acute myeloid leukemia. (Source 9)

Cool right?

Here’s the kicker, though. This trial is believed to be the ONLY randomized Phase 3 trial to offer BMT, the only potentially curative treatment option, to this patient population. (Source 9)

Plus, Iomab-B is a radiotherapy that targets cells expressing CD45. This protein is found only on blood cancer cells and immune cells, including bone marrow stem cells, with the radioisotope iodine-131. It is intended to be a targeted conditioning agent to enable potentially curative BMTs. (Source 9)

This could completely revolutionize the medical community…especially when you consider how impressive trial data already looks: (Source 12)

Wake up and smell the Iomab-B. If all goes according to plan Actinium Pharmaceuticals (NYSE:ATNM) could completely transform cancer treatment.

The Strengthening Its Patent Portfolio with International IP

Why limit yourself to one domestic market if you have such a potentially strong treatment candidate that could change the entire world?

Actinium recently announced that its intellectual property portfolio around Iomab-B has been further strengthened internationally. (Source 13)

“We are excited to expand our already robust patent portfolio with these key patents in the EU and Japan. As the only CD45 ARC for targeting conditioning in clinical development, these international patents, together with our U.S. patents lay the foundation for aggressive development of Iomab-B for BMT conditioning and Iomab-ACT for conditioning prior to cell and gene therapies. Iomab-B is well characterized and supported by extensive clinical data across multiple clinical trials and indications.”

“Our ARC approach has significant advantages over other approaches such as monoclonal antibodies or antibody-drug conjugates that require payload internalization, making them impractical for targeting CD45. We look forward to continuing to build our leadership position in targeted conditioning led by Iomab-B and remaining at the forefront of innovation in targeted radiotherapy.”

Analysts Are Going Crazy Over ATNM’s Potential Upside

While the ATNM stock did pull back in recent months, it may have caught strong double  bottom support around $4.41.

With new, potentially exciting developments within the company, the stock may have the potential to retest prior highs around $20 a share.

Many analysts are also not just going long on this stock. They’re going all in.

William Blair, for one, gives the stock an “Outperform” rating with a risk-adjusted fair value of $11.12 per share value. (Source 10)

Blair also stated that the “company finished the second quarter with a cash level of $81.9 million, which according to our estimates will likely sustain company operations into the first half of 2023, potentially beyond the Phase III SIERRA trial top-line readout.” (Source 10)

Most importantly, “Pending positive results from the Phase III SIERRA study and successful regulatory interactions with the FDA, [​​Iomab-B] is poised to disrupt the $600 million preconditioning market in the United States and Europe.” (Source 10)

Other analysts are even more bullish on the stock.

After ATNM announced full enrollment for its Phase III SIERRA Trial, Jones Trading immediately gave the company a $40 price target. (Source 16) Moreover, Jones Trading forecasted Actinium to see approximately $500 million in peak sales by 2032. (Source 16)

But what if I told you that this isn’t even the most bullish analyst call?! H.C. Wainwright gave the stock a $45 price target! (Source 4) That would give it potentially 773% upside (from close 4/7/22) of room to run!

773%!

Based on this rating, H.C. Wainwright says that “the common stock of the company is expected to outperform a passive index composed of all the common stock of companies within the same sector.” (Source 4)

But wait, there’s more…

Along with AVEO Technology, ATNM just entered into a research collaboration to develop and study a first-in-class antibody radio-conjugate (ARC) targeting ErbB3, also known as HER3, which is overexpressed in several solid tumor indications with high unmet needs, including colorectal, gastric, head and neck, breast, ovarian, melanoma, prostate and bladder cancers. (Source 25)

That could be substantial.

Even more impressive, Actinium just announced it entered into a research collaboration to study Actinium’s Actimab-A targeted radiotherapy in combination with RR-001, EpicentRx’s novel small molecule immunotherapy targeting AML. (Source 26)

It is no secret that biotech stocks are either hit or miss. But when they hit, the potential upside can be massive. Actinium Pharmaceuticals (NYSE: ATNM) could be our latest and most significant find in the biotech sector. It has a potentially revolutionary treatment rapidly progressing and the possibility to change the face of medicine as we know it.

And analysts see it.

If you don’t watch this one closely, you may regret it.

Management Team

Sandesh Seth

Chief Executive Officer and Chairman of the Board

Mr. Seth has 25+ years of experience in investment banking (Laidlaw& Co (UK) Ltd., Cowen & Co.), equity research (Bear Stearns, Commonwealth Associates) and in the pharma industry (Pfizer, Warner-Lambert, SmithKline in strategic planning, business development and R&D project management). Mr. Seth was chairman of Relmada Therapeutics Inc., a specialty pharma company focused on CNS therapeutics, which he helped co-found. Mr. Seth has an MBA in Finance from New York University; an M.S. in the Pharmaceutical Sciences from the University of Oklahoma Health Center and a B.Sc. in Chemistry from Bombay University. He has published several scientific articles and was awarded the University Regents Award for Research Excellence at the University of Oklahoma. Mr. Seth was designated as Regulatory Affairs Certified by the Regulatory Affairs Professionals Society which signifies proficiency with U.S. FDA regulations. He has several patents related to use of radiopharmaceuticals as conditioning agents for adoptive cell therapies and as therapeutic combinations.

Avinash Desai, MD

Chief Medical Officer

Dr. Desai is an industry veteran in the hematology and oncology field, most recently serving as Vice President, Head of U.S. Medical Affairs – Oncology at Glaxo Smith Kline (GSK). Over the course of his twenty-five-year career, Dr. Desai has successfully designed and implemented clinical development, U.S. and global medical affairs, and life cycle management plans for a variety of pharmaceutical products. This has included participation in multiple INDs, NDAs, and sNDA submissions and efficiently managing the product Scientific Advisory Boards (SAB) and Data and Safety Monitoring Boards (DSMB) for hematology, oncology and therapeutic candidates. At GSK, he established the U.S. medical affairs oncology team that oversaw the launch readiness plans for three novel oncology products—Blenrep® in multiple myeloma, Zejula® in ovarian cancer, and dostarlimab in endometrial cancer. In addition to GSK, Dr. Desai has overseen the clinical development, implementation and delivery of oncology life cycle management plans for various oncology therapies at several leading global pharmaceutical companies, including Eli Lilly & Company (Lilly), Janssen Pharmaceuticals, Inc. and Takeda, Inc. Prior to GSK, he was the VP of Global Medical Affairs at Lilly, during which time he oversaw the global medical affairs team for Lilly’s GI Oncology portfolio. Earlier in his career, Dr. Desai contributed to the approval of Janssen’s myeloma drug Darzalex® (daratumumab) and leading and strategically executing medical affairs activities globally for Velcade® (bortezomib). Prior to Janssen, Dr. Desai was responsible for the international development of oncology products in solid tumors and hematological malignancies at Sanofi, where he successfully executed pivotal trials that led to NDA submission for Jevtana® (cabazitaxel).

Arun Swaminathan, Ph.D.

Chief Business and Commercial Officer

Dr. Swaminathan is a highly accomplished executive with over 20 years of experience in the global biopharmaceutical industry, which has included increasing positions of responsibility across commercial, business development, and clinical roles. He has a proven track record of converting great science into successful business opportunities. Prior to joining Actinium, Dr. Swaminathan was the Chief Business Officer and Senior Vice President at Alteogen Inc. a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics. In this role, his negotiations with partners led to deals totaling over $6 billion in potential value, including agreements with two of the top ten global pharmaceutical companies. During his tenure at Alteogen, the Company’s market value increased from approximately $400 million to over $4 billion. Dr. Swaminathan joined Alteogen after they entered into an agreement with Lynkogen Inc. and gained full rights to develop the assets. As CEO and co-founder of Lynkogen, he raised capital, in-licensed potentially transformative drug candidates to address complex metabolic diseases and advanced Lynkogen from concept to a pre-clinical stage company with a lead drug candidate ready for IND enabling studies that he successfully negotiated for out-licensing.  Previously, Dr. Swaminathan held commercial and business development roles at Bristol Myers Squibb over 12 years during two tenures, most recently as Worldwide Brand Director, where he managed products with over $2 billion in annual sales across the top 10 global markets. Earlier at BMS, Dr. Swaminathan advanced from principal scientist to associate director, working on approved products including Nulojix®, Orencia® and Eliquis®. Between his tenures at BMS, he spent nearly four years at Covance (now Labcorp Drug Development), where he rose to Marketing Head, in charge of a $1 billion clinical business. Dr. Swaminathan received his Ph.D., Pharmaceutical Sciences at the University of Pittsburgh, and is a graduate of the Marketing Management Program at Wharton, University of Pennsylvania.

Steve O’Loughlin

Chief Financial Officer

Mr. O’Loughlin joined Actinium in October 2015 as Vice President, Finance and Corporate Development and was named Principal Financial Officer in May 2017 and Chief Financial Officer in July 2020. Steve possesses nearly fifteen years of life sciences industry experience gained from previous positions in investment banking and publicly traded life sciences companies. Prior to Actinium, from June 2015 to October 2015, Mr. O’Loughlin worked at J. Streicher LLC as an investment banker, from August 2012 to June 2015 Mr. O’Loughlin held the position of Vice President, Corporate Finance and Development and was a corporate officer at Protea Biosciences, Inc., a publicly traded life sciences company developing and commercializing mass spectrometry imaging and bioanalytic technologies and services. Previously, From June 2010 to June 2012, Mr. O’Loughlin held corporate development positions with Caliber I.D., (formerly Lucid, Inc.) a publicly traded company developing and commercializing VivaScope ®, an FDA cleared diagnostic device for the non-invasive assessment of the skin for skin cancer and other dermatologic conditions. Mr. O’Loughlin previously worked in investment banking at Jesup & Lamont where he focused on the biotechnology and life sciences industries. Mr. O’Loughlin has a B.S. in Business Administration with a concentration in finance from Ramapo College of New Jersey.

Helen Kotanides, Ph.D.

Vice President, Translational Research and Preclinical Development

Dr. Kotanides joins Actinium from Eli Lilly after a distinguished  career with continued succession through multiple positions culminating as Senior Research Advisor, Cancer Immunobiology. Dr. Kotanides brings nearly 25 years of R&D experience from  ImClone Systems and then Eli Lilly with a focus on the preclinical discovery and development of oncology biologic drugs. She has extensive first-hand knowledge and experience in cancer biology and immunotherapy, including target discovery and the testing, development, and advancement of biologics, immune checkpoint therapies, and targeted therapies. As a result, Dr. Kotanides has led several preclinical programs to successful IND filings. Dr. Kotanides received her Ph.D. in Molecular Biology and Biochemistry from the State University of New York at Stony Brook, her master’s degree in Biology from New York University and her bachelor’s degree in Biology from Clark University.

Monideepa Roy, Ph.D.

Vice President, Corporate Development – R&D

Dr. Roy is a scientist-entrepreneur  whose experience includes tenure as CEO of an early-stage oncology drug development company and nearly a decade in academic experience that includes training and work experience at Harvard Medical School/Brigham and Women’s Hospital. Dr. Roy joins Actinium from Akamara Therapeutics, where she most recently served as Vice President, Corporate Development and Operations. As a founding member and interim CEO at Akamara, she played a critical role in recruiting an executive team, establishing the Company’s corporate and R&D strategy, operational execution and growing the global team from 4 to 40. During her tenure at Akamara, she contributed to partnership/collaboration efforts, developed portfolio strategies, evaluated technology platforms, oversaw research activities to support IND filings, led regulatory preparation and submissions, and worked to generate and secure intellectual property. Prior to Akamara, she was Director, Research and Development at Invictus Oncology Pvt. Ltd., a drug discovery company developing novel I/O and conjugated antibody therapies. Here she co-led the licensing of technology from Brigham and Women’s Hospital, raised Series A financing, established the Company’s strategy around a B-cell immunotherapy platform and established an international research capability to advance the Company’s technologies. Additionally, she established a network of KOLs and identified and evaluated supramolecular platform technologies. Prior to industry, Dr. Roy was a Lecturer at Harvard University, was a Leukemia and Lymphoma Society Special Fellow and Research Fellow, Dept. Of Pathology at Brigham and Women’s Hospital/Harvard Medical School. Dr. Roy received her Ph.D. in Molecular Biology from Jawaharlal Nehru University, her master’s degree in Biophysics and Molecular Biology from the University College of Science, Calcutta and her bachelor’s degree in Human Physiology from Presidency College, Calcutta.

Dr. Mary Mei Chen, M.D., Ph.D.

Vice President, Clinical Development

Dr. Chen received training in both hematology (M.D.) and immunology (Ph.D.) followed by over twenty years of clinical research and development experience, including over ten years of biopharmaceutical industry experience and five years as a practicing hematologist. During her time in industry, she has led global, cross-functional teams in the design and execution of first-in-human clinical trials as well as trials in Phase 1 through Phase 3 in patients with AML, multiple myeloma, and breast cancer. She has contributed to the preparation and submission of regulatory documents and attended regulatory meetings to support Investigational New Drug (IND) and NDA applications in the US, EU, and other regions. Over the course of her career, she has authored over 50 peer reviewed publications in high impact journals.  Dr. Chen joins Actinium from GlycoMimetics, Inc., where she led multiple clinical trials including the global pivotal Phase 3 study of uproleselan (GMI-1271-301), which is enrolling 380 patients with R/R AML at approximately 50 centers across nine countries.  In this effort, Dr. Chen managed relationships with study investigators, created necessary protocols, Investigational Brochures, and target product profiles. Previously, Dr. Chen held the position of Medical Director, Global Clinical Lead–Clinical Science at Takeda Pharmaceuticals International where she developed clinical trials and protocols for T-cell and B-cell targeting therapies for oncology and inflammatory diseases. In this role, she successfully led multidisciplinary teams in the submission of an IND and Clinical Trial Application. Prior to Takeda, Dr. Chen worked at Pfizer (Wyeth), as Translational Medicine Team Lead-Translational Immunology. In this role, Dr. Chen supported biomarker development to support clinical development in hematology, oncology and inflammatory diseases for biologic and small molecules. At Pfizer, she contributed to the scientific, clinical and commercial development of the R&D pipeline and coordinated clinical development plans and protocols.

Prior to the biopharmaceutical industry, Dr. Chen was a researcher at the Harvard Medical School, Brigham and Women’s Hospital in the Department of Immunology, Rheumatology and Allergy, initially as a Postdoctoral Fellow before becoming Faculty Member, Instructor in Medicine. Mary received her Ph.D. in Immunology from Chiba University, Graduate School of Medicine in Tokyo, Japan. She completed her postdoctoral fellowship in the department of infection and host disease at Chiba University. Dr. Chen received her Doctor of Medicine degree from Shanghai Jiao Tong University, School of Medicine.

Paul Diamond, Ph.D., J.D.

Vice President, Patent and Legal Counsel

Dr. Diamond joins Actinium with over 20 years of experience in patent law, developing and executing IP strategy within the biotechnology industry. He joins Actinium from Enzo Biochem, Inc., where he was Senior Counsel, Patents and Business Development. As Enzo’s sole patent attorney and senior-most counsel, he reported to the CEO and led all IP related and essential in-house legal functions. During his time at Enzo, Dr. Diamond obtained critical, high-value patent coverage for key products and technologies and managed high-profile litigations and settlement negotiations that resulted in a number of sizeable settlements. Prior to Enzo, Dr. Diamond first practiced IP law at global law firm White & Case LLP before opening his own practice, Diamond Law Office, LLC, where he was of counsel to the firms Lucas & Mercanti, LLP and Zuber, Lawler & Del Duca, LLP. Paul received his law degree from Fordham University School of Law. He also has a strong scientific background, receiving a B.A. in Biology from The Johns Hopkins University and a Ph.D. in Molecular and Cellular Biology from Harvard University.

News

Source 1: https://ir.actiniumpharma.com/press-releases/detail/401

Source 2: https://finance.yahoo.com/quote/MRNA/history?p=MRNA

Source 3: https://fknol.com/list/best-performing/biotech-stocks.php

Source 4: Client Provided Analyst Material HC Wainwright

Source 5: https://www.marketsandmarkets.com/Market-Reports/chronic-lymphocytic-leukemia-223.html

Source 6: https://checkrare.com/targeted-therapy-for-acute-myeloid-leukemia/

Source 7: https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics

Source 8: https://cancer.ca/en/cancer-information/cancer-types/acute-myelogenous-leukemia-aml/treatment/relapsed-or-refractory

Source 9: https://www.prnewswire.com/news-releases/actinium-completes-enrollment-in-the-pivotal-phase-3-sierra-trial-of-iomab-b-301377219.html

Source 10: Client Provided Analyst Material William Blair

Source 11: https://d1io3yog0oux5.cloudfront.net/_7a9aad056eac4863c502660ef790af6d/actiniumpharma/db/206/944/pdf/Actinium_InvestorPresentation_September+2021.pdf

Source 12: https://ir.actiniumpharma.com/press-releases/detail/398/pivotal-phase-3-sierra-trial-data-showing-100-bone-marrow

Source 13: https://www.prnewswire.com/news-releases/actinium-further-strengthens-patent-portfolio-with-international-ip-covering-the-composition-and-methods-of-administration-of-iomab-b-antibody-radiation-conjugate-in-the-eu-and-japan-301314557.html

Source 14: https://stockcharts.com/h-sc/ui?s=atnm

Source 15: https://stockcharts.com/h-sc/ui

Source 16: Client Provided Analyst Material Jones Trading

Source 17: https://ir.actiniumpharma.com/press-releases/detail/412/actinium-pharmaceuticals-inc-announces-greater-difference

Source 18: https://www.tipranks.com/news/blurbs/maxim-group-sticks-to-its-buy-rating-for-actinium-pharmaceuticals-atnm/

Source 19: https://www.prnewswire.com/news-releases/actinium-announces-multiple-abstracts-highlighting-iomab-b-and-actimab-a-accepted-for-presentation-at-the-63rd-annual-american-society-of-hematology-annual-meeting-301416516.html

Source 20: https://www.actiniumpharma.com/product-pipeline/iomab-b

Source 21: https://www.barchart.com/stocks/quotes/ATNM/opinion

Source 22: https://invezz.com/news/2021/11/09/market-highlights-stocks-react-to-earnings-rele[…]nvests-250-billion-in-autolus-elon-musk-to-sell-10-tesla-stake/

Source 23: https://finance.yahoo.com/news/actinium-pharmaceuticals-inc-announces-greater-123000631.html

Source 24: https://d1io3yog0oux5.cloudfront.net/_6ce8013bee626e168ac4cd2f3de00f02/actiniumpharma/db/206/944/pdf/Actinium_Investor+Presentation_April+2022+%281%29.pdf

Source 25: https://investor.aveooncology.com/news-releases/news-release-details/actinium-pharmaceuticals-inc-and-aveo-oncology-enter-research

Source 26: https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-inc-and-epicentrx-announce-strategic-research-collaboration-to-combine-targeted-radiotherapies-with-next-generation-cd47sirp-immunotherapy-301454275.html

Sincerely,

Sincerely,

The Viral Stocks Team

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