aktive
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
What's wrong? I don't understand! Down 5$ in two days! Why? Results are out and not so bad?
Is a quiet board the last few weeks!
Why, why, why
Why does the share price only know one direction?
Downward direction!
I'm in ATNM since Mai 2018. Never sold one share and i'm down 49%. That's a good investment! NOTLOL
That's a good question.
Markets up big and ATM down big.
Ma average is 12.83 on this. Deeeeep reeed
I hate this silence.
I've longer and bigger invested into this company. Holding shares since June 2018.
Down about 35% and hope that one day this company will have a real and selling Product or licenses.
I hate the silance on this board. LOL
Happy New Year everyone!May all your resolutions come true and the earth be a little more peaceful. Of course, especially the climate, ....
I need an average of 0.5145 to break even. In since March 2018 and I've averaged up . My position is not so small NOTLOL. Thats the reason I'm waiting this out.
Thanks for clarifying. GLTA
$4.00?? or higher?
Devil May Cry?
Can you please explain "DMC"? Don't understand,.... TIA
Yes, crazy cheap is also my investing in ATNM, NOTLOL
Deep red and I don't think this will change soon.
I just donn't believe that the price is going up this year. And then the next massive share increase to stay in business. I'm lost or not?
Only one direction -> down. WHY?
The needed increase in shares is not the only reason for this slowdown?
Hope that not pennylans is in sight?
I'm a shareholder more than one year right now and the invested value is only 50% worth. NOTLOL
calm before the storm
absolute silence on this board
My investment needs a lot of patience and trust in this company, ... LOL
In the red Area for now. Need 0.61 to get even after green area middle october last jear
Actinium Pharmaceuticals Inc (ATNM-US): Hot property mis-priced
Dec. 17, 2018 at 8:41 a.m. ET on EQS Group AG
Hot property mis-priced
I've no clue why the stock price is dropping so fast.`Peak .85 to .50 is a big big drop. Nothing has realy changed. 10Q looks not so bad to me. Any toughts
Never thought that we will see the 50s again. NOTLOL
10-Q: ACTINIUM PHARMACEUTICALS, INC.
Published: Nov 9, 2018 5:07 p.m. ET
(EDGAR Online via COMTEX) -- ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
FORWARD-LOOKING STATEMENT NOTICE
This Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "estimate" or "continue" or comparable terminology are intended to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control.
Description of Business
Actinium Pharmaceuticals, Inc. (the "Company", "Actinium", or "We") is focused on improving patient access and outcomes to cellular therapies such as bone marrow transplant (BMT) and CAR-T with its proprietary, chemotherapy free or sparing, targeted conditioning technology. CAR-T is a type of cellular therapy that genetically alters a patient's own T cells to target and kill their cancer cells. Currently, there are 2 approved CAR-T therapies for patients with certain B-cell cancers and over 200 CAR-T candidates in preclinical and clinical development for a wide range of hematologic and solid tumor indications. Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning. Its targeted conditioning technology is enabled by ARC's or Antibody Radio-Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium's pipeline of clinical-stage targeted conditioning ARCs target the antigens CD45 and CD33 for patients with a broad range of hematologic malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM), acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma and Non-Hodgkin's lymphoma. Actinium's Iomab-ACT program is designed to be a universal lymphodepletion technology intended to eliminate the need for chemotherapy-based conditioning prior to CAR-T or other adoptive cellular therapies.
Iomab-B, Actinium's lead targeted conditioning product candidate, is currently enrolling patients in the pivotal Phase 3 SIERRA trial in patients age 55 or older, with active, relapsed or refractory AML. Iodine-131-apamistamab (Iomab-B), combines the anti-CD45 monoclonal antibody labeled with iodine-131 for myeloablation prior to a bone marrow transplant. CD45 is expressed on leukemia, lymphoma and normal immune cells. Iomab-B has been studied in over 500 patients in 10 clinical trials in numerous hematologic diseases. Actinium's Iomab-ACT program is an expansion of its CD45 program that is intended to be a universal, chemotherapy-free solution for targeted lymphodepletion prior to CAR-T therapy. CAR-T is a type of cellular therapy that genetically alters a patient's own T cells to target and kill their cancer cells. Currently, there are 2 approved CAR-T therapies for patients with certain B-cell cancers and over 200 CAR-T candidates in preclinical and clinical development for a wide range of hematologic and solid tumor indications. Through targeted lymphodepletion, the Iomab-ACT program is expected to improve CAR-T cell expansion, reduce CAR-T related toxicities and expand patient access to CAR-T treatment and potentially other adoptive cell therapies. Due to its lower payload dose, lymphodepletion with the Iomab-ACT program can be accomplished through a single outpatient infusion. Actinium intends to advance its Iomab-ACT program with CAR-T focused collaborators from academia and industry.
Actinium's pipeline also includes a potentially best-in-class CD33 program with its ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in multiple clinical trials for targeting conditioning and as a therapeutic as a single agent or in combination in multiple diseases and indications including AML, MDS and MM. Actinium applies its CD33 program at high doses to target CD33+ cells of the myeloid lineage in combination with reduced intensity conditioning (RIC), which together are intended to result in myeloablative outcomes with a more benign and well tolerated profile than high intensity chemotherapy myeloablation. Actinium is focused on applying its CD33 program at low doses in combination with other therapeutic modalities including chemotherapy, targeted agents and immunotherapies.
Actinium is also developing its proprietary AWE or Antibody Warhead Enabling technology platform which utilizes radioisotopes including iodine-131 and the highly differentiated actinium-225 coupled with antibodies to target a variety of antigens that are expressed in hematological and solid tumor cancers. The AWE technology enables Actinium's internal pipeline and with the radioisotope Actinium-225 is being utilized in a collaborative research partnership with Astellas Pharma, Inc. Actinium's clinical programs and AWE technology platform are covered by a portfolio of 75 patents covering composition of matter, formulations, methods of use and also methods of manufacturing the radioisotope Actinium-225 in a cyclotron.
We have also developed proprietary know-how related to the development, manufacturing and supply chain required for our product candidates. We supply our product candidates to clinical trial sites on a just in time basis through the management of the manufacturing our drug product components, final drug product and the distribution of our final drug product to medical centers where our trials are conducted. In the case of Iomab-B, we calculate, produce and supply personalized doses of drug for our clinical trial. We have secured access to I-131 produced by two premier commercial global suppliers that provide reliable and redundant supplies of I-131 and we have the additional security of an ensured supply as this radioisotope has been commoditized. We continually evaluate additional I-131 suppliers on a global basis and may add additional suppliers if we determine it would be beneficial to our clinical or commercial needs. The current supply of I-131 is able to meet our commercial needs for the Iomab-B program. We have a secure and reliable supply of Ac-225 with sufficient quantities of the radioisotope produced to address multiples of our current Ac-225 needs, facilitating pre-commercial and early commercial development. Our current source of Ac-225 is derived from the natural decay of thorium-229 (Th-229), so-called 'thorium cows' and supplied by the United States Department of Energy, or DOE with whom we have had a long-standing relationship. To further support the expansion of the thorium cows the DOE is engaged in a project to generate new thorium cows from its stockpile of uranium-233. An alternative accelerator-produced source of Ac-225 is currently being evaluated by Actinium. The Department of Energy, has indicated that the capacity of Ac-225 from this route is expected to be sufficient to supply all of Actinium's pipeline and commercial Ac-225 needs and support out potential program expansion. Actinium has intellectual property and developed know-how for Ac-225 production in a cyclotron which represents an additional and captive route towards high-quality and proprietary Ac-225 supply
Plan of Operation
Our current operations are primarily focused on furthering the development of our clinical drug candidates including Iomab-B and our CD33 program candidates for targeted conditioning and therapeutic indications, supporting investigator-initiated clinical trials that use our product candidates and leveraging our AWE platform to create new clinical programs and to enable collaborations.
Operations related to Iomab-B include progressing the ongoing multi-center Phase 3 pivotal trial (a trial that could lead to registration trial marketing approved by the FDA), that includes investigator engagement, site activation and supporting patient enrollment. In addition, we are focused on commercial-scale manufacturing of apamistamab suitable for a registration trial and preparation of appropriate regulatory submissions. We are also focused on producing final Iomab-B drug product material that consists of apamistamab labelled with the isotope I-131. Operations related to our planned Actimab-MDS trial include preparation for appropriate regulatory submissions, protocol development and investigator engagement.
In the case of our CD33 program, key ongoing activities include progressing the Actimab-A combination trials with Venetoclax and Venetoclax with hypomethylating agents, the Phase 1 Actimab-M trial, the Phase 1 Actimab-A CLAG-M combination trial and the Phase 1 Actimab-A MRD trial, managing isotope and other materials, supply chain and managing the manufacturing of the finished drug candidate product.
We have primarily management position employees and consultants who direct, organize and monitor the activities described above through contractors. We also make clinical trial arrangements with other well-known cancer centers. Our Iomab-B and CD33 ARCs and their components are contract-manufactured and maintained under our supervision by specialized contract manufacturers and suppliers in the United States.
We have never generated revenue. Currently we do not have a recurring source of revenue to cover our operating costs. For the nine months ended September 30, 2018 and 2017, we incurred a net loss of $17.3 million and $21.4 million, respectively.
Opportunities, Challenges and Risks
The market for drugs for cancer treatment is a large market in need of novel products, in which successful products can command multibillion dollars in annual sales. A number of large pharmaceutical and biotechnology companies regularly acquire products in development, with preference given to products in Phase 2 or later clinical trials. These transactions are typically structured to include an upfront payment that ranges from several million dollars to tens of million dollars or more and additional milestone payments tied to regulatory submissions and approvals and sales milestones. Our goal is to develop our product candidates through Phase 2 clinical trials and enter into partnership agreements with one or more large pharmaceutical and/or biotechnology companies.
We believe our future success will be heavily dependent upon our ability to successfully conduct clinical trials and preclinical development of our drug candidates. In addition, we plan to continue and expand other research and clinical trial collaborations. Moreover, we will have to maintain sufficient supply of Ac-225 and successfully maintain and if and when needed replenish or obtain our reserves of monoclonal antibodies. We will have to maintain and improve manufacturing procedures we have developed for production of our drug candidates from the components that include the I-131 and Ac-225 isotopes, monoclonal antibodies and other materials. It is possible that despite our best efforts our clinical trials results may not meet regulatory requirements for approval. If our efforts are successful, we may be able to partner our development stage products on commercially favorable terms if they enjoy appropriate patent coverage and/or considerable know-how and other protection that ensures market exclusivity. For these reasons, we intend to continue our efforts to maintain existing and generate new intellectual property. Intellectual property is a key factor in the success of our business as well as market exclusivity.
To achieve our goal, we intend to continue to invest in research and development at high rates, thus incurring further losses until one or more of our products are sufficiently developed to partner them with a large pharmaceutical and/or biotechnology company.
Results of Operations - Three Months Ended September 30, 2018 Compared to Three Months Ended September 30, 2017 The following table sets forth, for the periods indicated, data derived from our statements of operations: For the Three Months Ended September 30, 2018 2017 Revenue $ - $ - Operating expenses: Research and development, net of reimbursements 4,221,320 5,026,615 General and administrative 1,962,662 1,657,376 Depreciation expense 13,284 11,048 Total operating expenses 6,197,266 6,695,039 Other income: Interest income 49,177 49 Gain on change in fair value of derivative liabilities - 372,117 Total other income 49,177 372,166 Net loss $ (6,148,089 ) $ (6,322,873 )
Revenue
We recorded no commercial revenue for the three months ended September 30, 2018 and 2017.
Research and Development Expense
In March 2018, we entered into a research and option agreement with Astellas to develop Actinium-225 Radio-Conjugates, or ARCs, using our Actinium Warhead Enabling, or AWE, Platform Technology. Under this collaboration, we will utilize our AWE Platform to conjugate and label selected Astellas targeting agents with an Actinium-225 payload. We will also be responsible for conducting preclinical validation studies on any ARCs generated.
Research and development expenses declined approximately $0.8 million to $4.2 million for the three months ended September 30, 2018 compared to $5.0 million for the three months ended September 30, 2017. The decrease was primarily attributable to lower expenses related to Iomab-B, as well as the recognition of payments received from Astellas. Such payments are accounted for as a reduction in research and development expenses.
General and Administrative Expenses
General and administrative expenses of $2.0 million for the three months ended September 30, 2018 increased $0.3 million compared to $1.7 million for the three months ended September 30, 2017. The increase was primarily attributable to compensation expense relating to the timing of the payment of bonuses to employees and stock option compensation.
Other Income
Other income of $49 thousand for the three months ended September 30, 2018 was attributable to interest income.
Historically, we accounted for certain instruments which do not have fixed settlement provisions as derivative instruments in accordance with FASB ASC 815-40, Derivative and Hedging - Contracts in Entity's Own Equity. This was due to an anti-dilution provision for certain warrants that provide for a reduction to the exercise price if we issued equity or equity-linked instruments at an effective price per share less than the exercise price then in effect for the warrant, or a "down round provision". As such, the warrants were re-measured at each balance sheet date based on estimated fair value. Changes in estimated fair value were recorded as non-cash adjustments within other income in our accompanying Consolidated Statements of Operations. We recorded a gain on the change in the estimated fair value of warrants of $372 thousand for the three months ended September 30, 2017.
As of April 1, 2018, we early adopted ASU 2017-11, which revised the guidance for instruments with down-round provisions. As such, we treat outstanding warrants as free-standing equity-linked instruments that are recorded to equity in the Consolidated Balance Sheet as of January 1, 2018. As a result, there was no gain or loss from the valuation of the derivative liability recorded for the three months ended September 30, 2018.
Results of Operations - Nine Months Ended September 30, 2018 Compared to Nine Months Ended September 30, 2017 The following table sets forth, for the periods indicated, data derived from our statements of operations: For the Nine Months Ended September 30, 2018 2017 Revenues $ - $ - Operating expenses: Research and development, net of reimbursements 12,009,517 14,048,315 General and administrative 5,416,184 7,609,309 Depreciation expense 38,064 46,303 Total operating expenses 17,463,765 21,703,927 Other income: Interest income 129,549 49 Gain on change in fair value of derivative liabilities - 265,714 Total other income 129,549 265,763 Net loss $ (17,334,216 ) $ (21,438,164 )
Revenues
We recorded no commercial revenues for the nine months ended September 30, 2018 and 2017.
Research and Development Expense
Research and development expenses declined $2.0 million to $12.0 million for the nine months ended September 30, 2018 compared to $14.0 million for the nine months ended September 30, 2017. The decrease was primarily attributable to lower expenses related to Iomab-B, as well as the recognition of payments received from Astellas. Such payments are accounted for as a reduction in research and development expenses.
General and Administrative Expenses
General and administrative expenses declined approximately $2.2 million to $5.4 million for the nine months ended September 30, 2018 compared to $7.6 million for the nine months ended September 30, 2017, primarily attributable to lower compensation expense, resulting from lower stock option expense and lower payroll.
Other Income
Other income of $129 thousand for the nine months ended September 30, 2018 was attributable to interest income. Other income of $266 thousand in the prior-year period is due to the change in valuation of our warrant derivative liability. Upon the adoption of ASC 2017-11 as of April 1, 2018, the warrants previously accounted for as derivative liability were reclassified to equity. As a result, there was no gain or loss from the valuation of the derivative liability recorded for the nine months ended September 30, 2018.
Liquidity and Capital Resources We have financed our operations primarily through sales of our stock and warrants. The following tables sets forth selected cash flow information for the periods indicated: For the Nine Months Ended September 30, 2018 2017 Cash used in operating activities $ (16,284,173 ) $ (18,384,823 ) Cash used in investing activities (85,522 ) (23,480 ) Cash provided by financing activities 13,815,586 18,787,105 Net change in cash, cash equivalents and restricted cash $ (2,554,109 ) $ 378,802
Net cash used in operating activities was $16.2 million and $18.3 million for the nine months ended September 30, 2018 and 2017, respectively. Net cash used in operating activities for the nine months ended September 30, 2018 primarily reflects our net loss for the period of $17.3 million adjusted for various non-cash charges and income, including $1.4 million of stock-based compensation. Net cash used in operating activities for the nine months ended September 30, 2017 primarily reflects our net loss for the period of $21.4 million adjusted for various non-cash charges and income, including $2.9 million of non-cash stock-based compensation.
Net cash provided by financing activities was $13.8 million for the nine months ended September 31, 2018, reflecting our March 2018 sale of units, see below. During the nine months ended September 31, 2017, we received net proceeds of $18.8 million from the sale of our common stock and warrants.
As of September 30, 2018, our cash and cash equivalent balance was $14.8 million. We believe that we have sufficient cash to fund our operations through the next 12 months.
On October 18, 2018, we entered into a purchase agreement, or Purchase Agreement and a registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park pursuant to which the Company has the right to sell to Lincoln Park shares of our common stock having an aggregate value of up to $32,500,000, subject to certain limitations and conditions set forth in the Purchase Agreement. As consideration for entering into the Purchase Agreement, the Company issued to Lincoln Park 852,537 shares of common stock, (see Footnote 6 to the Consolidated Financial Statements).
Pursuant to the Purchase Agreement, Lincoln Park purchased 3,376,554 shares of common stock, at a price of $0.74 per share, for a total gross purchase price of $2,500,000. Through November 8, 2018, we elected to sell to Lincoln Park 1,000,000 shares and received $705,000.
Recent Equity Offerings
In March 2018, we sold 30,237,894 units consisting of 30,237,894 shares of common stock, 7,559,445 series A warrants and 22,678,393 series B warrants, with each series A warrant exercisable for one share of Common Stock at an exercise price of $0.60 per share and each series B warrant exercisable for one share of Common Stock at an exercise price of $0.70 per share.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have, or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Critical Accounting Policies and Use of Estimates
Our management's discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.
Our significant accounting policies are described in detail in the notes to our consolidated financial statements appearing in our Annual Report filed on Form 10-K for the year ended December 31, 2017.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
Research and Development Costs
Research and development costs are expensed as incurred.
Share-Based Payments
The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model. The fair value determined represents the cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for the award. The Company accounts for forfeitures of stock options as they occur.
Accounting Pronouncements Recently Adopted
In November 2016, the Financial Accounting Standards Board ("FASB") issued an Accounting Standards Update ("ASU") amending the presentation of restricted cash within the consolidated statements of cash flows. The new guidance requires that restricted cash be added to cash and cash equivalents on the consolidated statements of cash flows. The Company adopted this ASU on January 1, 2018 on a retrospective basis with the following impacts to our consolidated statements of cash flows for the nine months ended September 30, 2017:
Previously Reported Adjustment As Revised Net cash provided by (used in) investing activities $ (379,621 ) $ 356,141 $ (23,480 )
As of September 30, 2018 and December 31, 2017, the Company had a certified deposit of $390,940 as collateral for a letter of credit issued in connection with a lease agreement and as of September 30, 2018, the Company had restricted cash of $40,055 related to credit card accounts.
In May 2014, the Financial Accounting Standard Board ("FASB") issued ASU No. 2014-09, Revenue from Contracts with Customers. Under the new standard, revenue is recognized at the time a good or service is transferred to a customer for the amount of consideration for which the entity expects to be entitled for that specific good or service. Entities may use a full retrospective approach or report the cumulative effect as of the date of adoption. We adopted this ASU on January 1, 2018 and the adoption did not have a significant impact to the Company's financial statements.
In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity(Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features. These amendments simplify the accounting for certain financial instruments with down round features. The amendments require companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock, for purposes of determining liability or equity classification. The guidance was adopted as of April 1, 2018. See Note 2 to the consolidated financial statements for more details.
Recent Accounting Pronouncements
In February 2016, FASB issued ASU No. 2016-02 Leases (Topic 842), which creates new accounting and reporting guidelines for leasing arrangements. The new guidance requires organizations that lease assets to recognize assets and liabilities on the balance sheet related to the rights and obligations created by those leases, regardless of whether they are classified as finance or operating leases. Consistent with current guidance, the recognition, measurement, and presentation of expenses and cash flows arising from a lease . . .
Nov 09, 2018
(c) 1995-2018 Cybernet Data Systems, Inc. All Rights Reserved
Tomorrow we'l see some new highs i think or believe
NEWS - Actinium Pharmaceuticals CD33 Program to Focus on Actimab-MDS Pivotal Trial Enabling Study for Targeted Conditioning and Novel Combination Trials with Actimab-A and Venetoclax
Published: Oct 30, 2018 5:05 p.m. ET
- Positive FDA discussions for Actimab-MDS program enable accelerated pivotal trial pathway and broaden target patient population- Actimab-A development strategy in combinations with Venetoclax for AML informed by company research indicating potential synergy and support from leading physicians
NEW YORK, Oct. 30, 2018 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (nyse american:ATNM) announced today that the next stage of development for its CD33 ARC (Antibody Radiation Conjugate) Ac-225-Lintuzumab program, after successful completion of the Actimab-A phase 2 trial in Acute Myeloid Leukemia (AML), will incorporate two key initiatives; a pivotal trial pathway for its Actimab-MDS program for Myelodysplastic Syndromes (MDS), and also in two combination trials with Venetoclax for AML. Actinium's development strategy for its CD33 program is being informed by: clinical data from 4 trials totaling over 100 patients including the recent Actimab-A Phase 2 trial in AML; positive interactions with the FDA regarding its Actimab-MDS trial; company research findings regarding potential synergy with Venetoclax; support from leading physicians; and attractiveness of the targeted indications given the unmet medical need and potential of its differentiated ARC modality in combination with chemotherapy.
Actinium highlighted the outcome of its successful discussions with the FDA for the Actimab-MDS program, which resulted in guidance for an accelerated pathway to a pivotal trial after a short dose finding Phase 1 portion. Actinium's initial proposal to the FDA was to conduct a larger Phase 2 trial prior to a pivotal trial in patients with a TP53 mutation, however, the company was encouraged by the FDA to expand the trial to include all high-risk patients with poor or very poor and complex cytogenetics. The program will use the ARC Ac-225-lintuzumab for targeted conditioning in combination with a reduced intensity dose of fludarabine and melphalan prior to a BMT or Bone Marrow Transplant in patients with high-risk Myelodysplastic Syndrome (MDS).
See Also
How the Desire for Change Might Not Be Just an American Experience
×
Dr. Mark Berger, Actinium's Chief Medical Officer said, "In our studies to date, we've seen that Ac-225 – Lintuzumab can achieve remissions with minimal extramedullary toxicities even in patients progressing to AML from MDS. Typically, high-risk MDS patients undergoing a BMT do poorly with standard conditioning resulting in poor outcomes. The goal of the Actimab-MDS program is to use our ARC AC-225 – Lintuzumab to target cells of the myeloid lineage including progenitor cells in combination with reduced intensity conditioning with the goal of achieving improved conditioning and BMT outcomes, as successful BMT is the only potentially curative treatment option for these patients. We are building on the data we already have from our CD33 program and we are excited to have a quicker pathway to a pivotal trial that targets a larger patient population than originally envisaged."
Actinium's two combination trials with Venetoclax, a BCL-2 inhibitor that was jointly developed by AbbVie and Genentech, will leverage Actimab-A's unique and differentiated mechanism of action to explore synergies between the two agents for patients with relapsed or refractory AML. Venetoclax is an approved drug for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) and a supplemental New Drug Application (NDA) has been submitted to the FDA for patients newly diagnosed with AML. The first proposed study will evaluate Actimab-A in combination with Venetoclax and will be led by Dr. Gary Schiller, Director, Hematology/Stem Cell Transplantation at UCLA Medical center. The second study will evaluate Actimab-A in combination with Venetoclax and hypomethylating agents and will be conducted in collaboration with Dr. Hagop Kantarjian and Dr. Tapan Kadia of the MD Anderson Cancer Center. The company is pursuing these combination trials with Actimab-A and Venetoclax on the basis of internal preclinical studies which have demonstrated a synergistic effect between these two agents that is supported by a mechanistic rational. Specifically, patients with AML have high levels of MCL-1, a protein that mediates resistance to Venetoclax, which is known to be depleted by DNA damage caused by external radiation treatment. Preclinical studies have demonstrated that MCL-1 is effectively depleted by DNA damage caused by external radiation and Actinium believes that Actimab-A's targeted radiation mechanism will therefore lead to a greater effect of Actimab-A plus Venetoclax, as demonstrated in the Company's preclinical work.
Dr. Berger added, "Many therapeutic advances in oncology, and also in AML, have been the result of combination therapies. We are excited to be advancing our Actimab-A program in combination with Venetoclax, which has the potential to lead the next evolution of AML therapy, in collaboration with top thought leaders from leading medical institutions. As indicated by our collaborators during the CD33 Update webinar, while results with Venetoclax in patients with AML are encouraging, there remains a high unmet need for durable responses and curative outcomes. We believe Actimab-A can be used in combination with Venetoclax to improve patient outcomes, which is based on a strong scientific rationale supporting the combination as well as preclinical and clinical data. Our proposed trials with these combinations demonstrate the strong investigator interest we have seen for working with Ac-225 – Lintuzumab as an Antibody Radiation Conjugate is a new therapeutic modality for patients with radiation sensitive cancers such as AML, MDS and Multiple Myeloma that has the potential to improve their outcomes."
Sandesh Seth, Actinium's Chairman and Chief Executive Officer said, "Having a clear and relatively quick pathway to a pivotal trial for Actimab-MDS materially strengthens our targeted conditioning pipeline. It also enhances our outlook for building a business focused on developing and launching multiple products for targeted conditioning prior to BMT or CAR-T that can improve both patient access and outcomes due to their superior safety and efficacy balance compared to non-targeted chemotherapy that is current standard of care. With the solid progress of the Iomab-B Phase 3 trial for BMT, the recent launch of the Iomab-ACT program for CAR-T and the solid impetus for a near-term Actimab-MDS pivotal trial, our pipeline prospects for targeted conditioning have never been better."
Mr. Seth added, "The Actimab-A trial which was recently closed has been a big success as it has provided the foundation for the near-pivotal Actimab-MDS program in an area where there is high unmet need, no competing development programs by other companies and a larger patient population than originally envisaged. Additionally, our combination trials with Venetoclax and Actimab-A are very exciting as we have the opportunity to validate our preclinical research showing superiority of the combination in two highly relevant clinical settings where the unmet medical need continues to be high. Based on these recent developments, our CD33 Program has evolved much beyond the narrow AML focused CD33 programs in the industry due to the versatility of our ARC technology. The ARC approach has allowed us to expand into other radiation sensitive diseases such as multiple myeloma and MDS, and into targeted conditioning using high doses of the ARC as well as therapeutic combinations at lower ARC doses which allow incorporation of targeted radiation as another modality to treat highly radiation sensitive cancers."
"In addition," said Mr. Seth, "from a strategic perspective, the Actimab-MDS targeted conditioning trial strengthens our go-it-alone outlook. However, the other CD33 program developments including combination trials increase its attractiveness to potential collaborators and are expected to provide our company with attractive optionality going forward, as the period between now and 2019 are expected to yield several valuable clinical milestones and data readouts. We look forward to providing updates as value in this program continues to build."
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is focused on improving patient access and outcomes to cellular therapies such as bone marrow transplant (BMT) and CAR-T with its proprietary, chemotherapy free or sparing, targeted conditioning technology. Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning. Its targeted conditioning technology is enabled by ARC's or Antibody Radio-Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium's pipeline of clinical-stage targeted conditioning ARCs target the antigens CD45 and CD33 for patients with a broad range of hematologic malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM), acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma and Non-Hodgkin's lymphoma. Actinium's Iomab-ACT program is designed to be a universal lymphodepletion technology intended to eliminate the need for chemotherapy-based conditioning prior to CAR-T or other adoptive cellular therapies.
Iomab-B, Actinium's lead targeted conditioning product candidate, is currently enrolling patients in the pivotal Phase 3 SIERRA trial in patients age 55 or older, with active, relapsed or refractory AML. Iodine-131-apamistamab (Iomab-B), combines the anti-CD45 monoclonal antibody labeled with iodine-131 for myeloablation prior to a bone marrow transplant. CD45 is expressed on leukemia, lymphoma and normal immune cells. Iomab-B has been studied in over 500 patients in 10 clinical trials in numerous hematologic diseases. Actinium's Iomab-ACT program is an expansion of its CD45 program that is intended to be a universal, chemotherapy-free solution for targeted lymphodepletion prior to CAR-T. Through targeted lymphodepletion, the Iomab-ACT program is expected to improve CAR-T cell expansion, reduce CAR-T related toxicities and expand patient access to CAR-T treatment and potentially other adoptive cell therapies. Due to its lower payload dose, lymphodepletion with the Iomab-ACT program can be accomplished through a single outpatient infusion. Actinium intends to advance its Iomab-ACT program with CAR-T focused collaborators from academia and industry.
Actinium's pipeline also includes a potentially best-in-class CD33 program with its ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in multiple clinical trials for targeting conditioning and as a therapeutic as a single agent or in combination in multiple diseases and indications including AML, MDS and MM. Actinium applies its CD33 program at high doses to target CD33+ cells of the myeloid lineage in combination with reduced intensity conditioning (RIC), which together are intended to result in myeloablative outcomes with a more benign and well tolerated profile than high intensity chemotherapy myeloablation. Actinium is focused on applying its CD33 program at low doses in combination with other therapeutic modalities including chemotherapy, targeted agents and immunotherapies.
Actinium is also developing its proprietary AWE or Antibody Warhead Enabling technology platform which utilizes radioisotopes including iodine-131 and the highly differentiated actinium-225 coupled with antibodies to target a variety of antigens that are expressed in hematological and solid tumor cancers. The AWE technology enables Actinium's internal pipeline and with the radioisotope Actinium-225 is being utilized in a collaborative research partnership with Astellas Pharma, Inc. Actinium's clinical programs and AWE technology platform are covered by a portfolio of 75 patents covering composition of matter, formulations, methods of use and also methods of manufacturing the radioisotope Actinium-225 in a cyclotron.
More information is available at www.actiniumpharma.com and our Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contact:
Actinium Pharmaceuticals, Inc. Steve O'Loughlin
Principal Financial Officer
soloughlin@actiniumpharma.com
Investor Relations Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/actinium-pharmaceuticals-cd33-program-to-focus-on-actimab-mds-pivotal-trial-enabling-study-for-targeted-conditioning-and-novel-combination-trials-with-actimab-a-and-venetoclax-300740769.html
SOURCE Actinium Pharmaceuticals, Inc.
Copyright (C) 2018 PR Newswire. All rights reserved
Sounds realy bullisch
NEWS - Actinium Pharmaceuticals Announces Webinar Showcasing Actimab-A Post Phase 2 Trial Plans and Actimab-MDS Regulatory Update
Published: Oct 22, 2018 8:04 a.m. ET
- Dr. Gary Schiller, Professor of Medicine, Hematology-Oncology at UCLA Medical Center and Dr. Tapan Kadia, Associate Professor of Medicine, at MD Anderson Cancer Center to highlight post Phase 2 development plans for Actimab-A- Actimab-MDS Targeted Conditioning Trial Pathway to be Highlighted Following Positive Interactions with the FDA- Conference call and webcast to be held Friday, October 26th at 11:00 AM ET
NEW YORK, Oct. 22, 2018 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (nyse american:ATNM) announced today that it will host a conference call and webinar to provide key updates on the advancement of its CD33 program on Friday, October 26, 2018 at 11:00 AM ET. Actinium's CD33 program utilizes the Antibody Radio-Conjugate (ARC), lintuzumab-Ac-225 for hematologic indications including Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM). Actinium recently completed its Phase 2 Actimab-A trial in patients newly diagnosed with AML who are over the age of 60 and unfit for intensive chemotherapy. Dr. Gary Schiller Professor Medicine, Hematology-Oncology at UCLA Medical Center and Dr. Tapan Kadia, Assistant Professor of Medicine, Department of Leukemia at the MD Anderson Cancer Center will highlight Actinium's post Phase 2 trial development plans for Actimab-A in AML.
Actinium is also developing Actimab-MDS, which is intended to be a single dose, chemotherapy-sparing targeted conditioning agent for patients with high-risk MDS. Currently, this patient population either cannot undergo a bone marrow transplant or have poor outcomes. Management will provide an update on the regulatory pathway for Actimab-MDS following positive interactions with the U.S. Food and Drug Administration (FDA).
Dr. Mark Berger, Actinium's Chief Medical Officer said, "Our CD33 program has progressed significantly in 2018 resulting in a highly valuable body of data that we are using to inform our ongoing development strategy. Our Antibody Radio-Conjugate approach, given its differentiated mechanism of action, has allowed us to expand this program beyond a traditional AML directed approach which is where other CD33 programs in the industry are focused. The unique ability of our ARC's enable cell killing to occur not just via internalization of the antigen but also from the cell surface and by crossfire. In addition, our ARCs labeled with radioactive actinium are characterized by the high linear energy transfer of alpha radiation which is able to cause double stranded DNA breaks via a single alpha particle hit. This potent cell killing power of alpha radiation when used in an efficiently targeted manner as in our Actimab program enables us to expand into other radio-sensitive CD33 expressing malignancies such as multiple myeloma and now for targeted conditioning for MDS, both of which are indications where Actinium is developing the only CD33 targeting agent. In addition, we have moved into a novel combination trial for patients with significant unmet need with our Actimab-A CLAG-M study. We are pleased to have made this progress, but we believe the next evolution of our CD33 program will be even more exciting. As such, we look forward to highlighting our post Phase 2 trial development plans for Actimab-A with Dr. Schiller and Dr. Kadia."
Sandesh Seth, Actinium's Chairman and Chief Executive Officer said, "We are excited to introduce these latest initiatives as they clearly establish Actinium's Antibody Radio-Conjugate based CD33 program as the industry leader. Further, we are about to enter a period that will showcase data from several of the CD33 program initiatives that this team has advanced. Given the inherent nature of our technology, the expertise of our team and strong relationships with thought leaders, we have been able to craft a development strategy that leverages the strengths of our drug candidates and Antibody Warhead Enabling technology platform into indications with high unmet medical needs. The webinar will showcase the attractiveness of using our Antibody Radiation-Conjugate approach in meeting these needs. In addition, it will establish the strategic importance of Actimab-MDS in enabling our company to develop a multi-asset pipeline of targeted conditioning agents which have the potential to improve access and outcomes for patients undergoing bone marrow transplant and cellular therapy in a chemotherapy-free or chemotherapy-sparing manner."
Conference call and webcast Participation Information Date:Friday, October 26, 2018
Time:11:00 AM ET
Webcast Registration: https://onecast.thinkpragmatic.com/ses/9DnzzB5lR-DnSV3zQJ1LDQ~~
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is focused on improving patient access and outcomes to cellular therapies such as bone marrow transplant (BMT) and CAR-T with its proprietary, chemotherapy free or sparing, targeted conditioning technology. Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning. Its targeted conditioning technology is enabled by ARC's or Antibody Radio-Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium's pipeline of clinical-stage targeted conditioning ARCs target the antigens CD45 and CD33 for patients with a broad range of hematologic malignancies including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM), acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma and Non-Hodgkin's lymphoma. Actinium's Iomab-ACT program is designed to be a universal lymphodepletion technology intended to eliminate the need for chemotherapy-based conditioning prior to CAR-T or other adoptive cellular therapies.
Iomab-B, Actinium's lead targeted conditioning product candidate, is currently enrolling patients in the pivotal Phase 3 SIERRA trial in patients age 55 or older, with active, relapsed or refractory AML. Iodine-131-apamistamab (Iomab-B), combines the anti-CD45 monoclonal antibody labeled with iodine-131 for myeloablation prior to a bone marrow transplant. CD45 is expressed on leukemia, lymphoma and normal immune cells. Iomab-B has been studied in over 500 patients in 10 clinical trials in numerous hematologic diseases. Actinium's Iomab-ACT program is an expansion of its CD45 program that is intended to be a universal, chemotherapy-free solution for targeted lymphodepletion prior to CAR-T. Through targeted lymphodepletion, the Iomab-ACT program is expected to improve CAR-T cell expansion, reduce CAR-T related toxicities and expand patient access to CAR-T treatment and potentially other adoptive cell therapies. Due to its lower payload dose, lymphodepletion with the Iomab-ACT program can be accomplished through a single outpatient infusion. Actinium intends to advance its Iomab-ACT program with CAR-T focused collaborators from academia and industry.
Actinium's pipeline also includes a potentially best-in-class CD33 program with its ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in multiple Phase 2 and Phase 1 clinical trials for targeting conditioning and as a therapeutic in multiple diseases and indications including AML, MDS and MM. Actinium applies its CD33 program at high doses to target CD33+ cells of the myeloid lineage in combination with reduced intensity conditioning (RIC), which together are intended to result in myeloablative outcomes with a more benign and well tolerated profile than high intensity chemotherapy myeloablation. Actinium is focused on applying its CD33 program at low doses in combination with other therapeutic modalities including chemotherapy, targeted agents and immunotherapies.
Actinium is also developing its proprietary AWE or Antibody Warhead Enabling technology platform which utilizes radioisotopes including iodine-131 and the highly differentiated actinium-225 coupled with antibodies to target a variety of antigens that are expressed in hematological and solid tumor cancers. The AWE technology enables Actinium's internal pipeline and with the radioisotope Actinium-225 is being utilized in a collaborative research partnership with Astellas Pharma, Inc. Actinium's clinical programs and AWE technology platform are covered by a portfolio of 77 patents covering composition of matter, formulations, methods of use and also methods of manufacturing the radioisotope Actinium-225 in a cyclotron.
More information is available at www.actiniumpharma.com and our Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contact:
Actinium Pharmaceuticals, Inc. Steve O'Loughlin
Principal Financial Officer
soloughlin@actiniumpharma.com
Investor Relations Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/actinium-pharmaceuticals-announces-webinar-showcasing-actimab-a-post-phase-2-trial-plans-and-actimab-mds-regulatory-update-300734989.html
SOURCE Actinium Pharmaceuticals, Inc.
Copyright (C) 2018 PR Newswire. All rights reserved
FORM 8-K: ACTINIUM PHARMACEUTICALS FILES CURRENT REPORT [U.S. Fed News]
Fri Oct 19 23:20:27 2018 EDT
WASHINGTON, Oct. 20 -- Actinium Pharmaceuticals Inc., New York, files Form 8-K (current report) with Securities and Exchange Commission on Oct. 18.
State of Incorporation/State or other jurisdiction of incorporation: Delaware
Item 1.01 Entry into a Material Definitive Agreement.
On October 18, 2018, Actinium Pharmaceuticals, Inc. (the "Company") and Lincoln Park Capital Fund, LLC ("Lincoln Park") entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company's common stock having an aggregate value of up to $32,500,000, subject to certain limitations and conditions set forth in the Purchase Agreement (the "Offering").
More information can be viewed at: http://www.sec.gov/Archives/edgar/data/1388320/000121390018014103/f8k101918_actiniumpharma.htm For any query with respect to this article or any other content requirement, please contact Editor at contentservices@htlive.com
SID(HINDf7e795d6263628ed5f8)
ATNM
IC/hlth IC/hlth.phrm IS/biz.corpcomm IS/biz.filings IS/biz.form8k IS/biz.matevent IS/biz.spec IS/spec LC/us LR/am LR/nam
NEWS - Actinium Pharmaceuticals announces dosing of 38th patient and 25% enrolment in Iomab-B pivotal SIERRA trial.
Wed Oct 10 02:32:24 2018 EDT
On 26 Jun 2018, Actinium Pharmaceuticals Inc, announced that it has dosed the 38th patient in the pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly Relapse Refractory Acute Myeloid Leukaemia) study of Iomab-B, reaching 25% of patient enrolment. As a result, the trial's independent Data Monitoring Committee (DMC) will review the trial data at its next meeting, which has been scheduled for Aug 2018. The SIERRA trial is a 150 patient, randomized, and controlled multi-centre trial that is currently open at 16 leading transplant centres in the US. The company highlighted the recent initiatives taken to strengthen the outlook for the trial. Based on the higher than anticipated crossover rate previously announced after the first DMC meeting, the company deemed it appropriate to increase the number of additional treatment options acceptable for utilization in the control arm. This was done to accommodate requests from the principal investigators at various sites. The amended protocol now allows additional treatment options in the control arm including Mylotarg, Venetoclax, and the FLT3 inhibitors Midostaurin and Sorafenib. Importantly, the company notes that these treatments may be used based on the preference and discretion of the treating physician in keeping with the design of the study's control arm and are not approved treatments for this patient population. The recent protocol changes have been implemented following review by the FDA and IRB approvals. The company has also made valuable additions to its clinical organization. The company also materially strengthened its clinical operations group with the addition of two directors, two clinical trial associates and a clinical education and support specialist nurse. These initiatives taken since the first DMC update have enabled the recent milestone and are expected to ensure the continued strong progress of the SIERRA trial including both site expansion and enrolment. Following successful enrolment of 25% of patients in the SIERRA trial, the company expects to activate additional clinical trial sites in the US and Canada with a continued emphasis on leading high-volume BMT centres. In addition, Actinium intends to open clinical trial sites in Europe where Iomab-B has been granted Orphan designation by the European Medicines Agency (EMA) and received Scientific Advice establishing a clear pathway to submit for EU marketing authorization upon successful completion of the SIERRA trial. Based on current forecasts, Actinium expects to complete patient enrolment in 2019. In anticipation of trial completion, Actinium is taking necessary steps to prepare for a Biologics License Application (BLA) submission and is undertaking pre-commercialization activities. The SIERRA trial will have multiple data readouts including scheduled DMC safety analyses after twenty-five, fifty and seventy-five percent of patients have been enrolled. In addition, Actinium, at its discretion, may request efficacy analyses by the DMC after 70 and 110 patients have reached the primary endpoint of durable complete remission (dCR) of at least 180 days. Original Source: Actinium Pharmaceuticals, 2018. Found on website: http://www.globenewswire.com.
SID(ELSEVIER78adf77ab2367bb)
Nobody out there?
thanks apollo. Let's see what ATNM has in store for all of us and the human beings. TIA and GLTA
NEWS - Actinium Pharmaceuticals Inc (ATNM-US): Improving access to CAR-T
Published: Sept 28, 2018 2:40 a.m. ET
goetzpartners securities Limited
Actinium Pharmaceuticals Inc (ATNM-US): Improving access to CAR-T
28-Sep-2018 / 07:39 GMT/BST
Free to access research and investor meetings in a post-MiFID2 world.This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients.Published to the market and investors on 28th September 2018 @ 7.17am (London time).Actinium Pharmaceuticals Inc (ATNM-US): Improving access to CAR-TRecommendation: OUTPERFORMTarget Price: USD$4.00 Current Price: USD$0.76 (COB on 27th September 2018) KEY TAKEAWAYWith its molecular-targeted radio-therapy Iomab-B showing promise and in a pivotal Phase III for bone marrow transplant, Actinium has initiated a programme to use lower dose (Iomab-ACT) to boost safety and efficacy of the much-vaunted CAR-T therapy in blood cancers. While the tens of billions USD spent on CAR-T assets highlight the potential, the extreme cost and safety concerns surrounding CAR-T have so far held back uptake of the two marketed products Kymriah (Novartis) and Yescarta (Kite Pharma / Gilead). Based on previous data, Actinium believes that replacing the current toxic pre-CAR-T conditioning regimen with targeted radiotherapy could improve patient outcomes, potentially reducing barriers to reimbursement and expanding patient access. Although the true scale of the CAR-T Iomab-ACT opportunity is unclear at this early stage, Actinium's new initiative further highlights the potential of its molecular-targeted radiotherapy in blood and immune diseases. We maintain and reiterate both our OUTPERFORM recommendation and TP of $4.00 / share as detailed in our initiation report of April 2018.Benefits of Iomab-ACT over chemo - Successful CAR-T therapy requires depletion of patient lymphocytes prior to treatment. Iomab-ACT therapy promises to provide specific targeting of lymphocytes, including cancer cells, provided by one dose in an out-patient setting. Current fludaribine / cyclophosphamide ("Flu-Cy") leads to non-specific blood cell depletion as well as other toxicity and requires multiple infusions over a number of days. Iomab-ACT has the potential for better efficacy, safety and convenience.CAR-T benefits come at a cost - The benefits of the already marketed products Kymriah and Yescarta in helping otherwise hopeless patients beat treatment refractory blood cancers including acute lymphoblastic leukaemia ("ALL"), diffuse large cell lymphoma ("DLCL") are well known. However, the enormous cost of manufacturing and supplying these personalised therapies (treatment costs approaching $500k) presents a significant barrier to reimbursement.Improved outcomes could facilitate reimbursement - Given the sky-high cost, payers increasing looking towards outcome-based reimbursement schemes for CAR-T based therapies. The improved safety and efficacy promised by Iomab-ACT compared to existing chemotherapeutic Flu-Cy regimens could facilitate such an outcome-based approach.Documented safety and efficacy of Iomab - Low dose Iomab has already been shown to deplete lymphocytes and is safe at much greater doses as documented in over 500 patients undergoing pre-bone marrow transplant conditioning. While Actinium has yet to disclose details, a relatively simple dosing trial of Iomab-ACT in combination with CAR-T is in planning by its clinical collaborators.Providing CAR-T players with freedom to operate - Flu-Cy lymphocyte depletion regimens for CAR-T is covered by a patent filed by Kite Pharma (owned by Gilead). An effective alternative conditioning pathway patented by Actinium could provide other CAR-T players freedom to operate.Significant upside - The prospect of significant clinical news flow from Actimab in H2/2018E and pivotal readout on Iomab-B suggests significant upside from current levels. As detailed in our initiation report of April 2018, our valuation suggests that Actinium still remains fundamentally undervalued at current levels. Our analysis indicates a current fair value of $2.60 per share rising to $5.00 per share on the back of positive phase 2 data in H2/2018E. We maintain and reiterate both our OUTPERFORM recommendation and target price of $4.00 per share.Kind regards, Chris Redhead | Analystgoetzpartners Healthcare Research Team | Research Teamgoetzpartners securities LimitedThe Stanley Building, 7 Pancras Square, London, N1C 4AG, England, UK.T +44 (0) 203 859 7725 | chris.redhead@goetzpartners.com / healthcareresearch@goetzpartners.comwww.goetzpartnerssecurities.comRegistered in England No. 04684144.Managing Directors: Dr Stephan Goetz, Martin Brunninger and Ulrich Kinzel.Click here to see our privacy policy.GPSL has a formal client relationship with Actinium Pharmaceuticals Inc.GPSL publishes and distributes "Investment" Research and "Corporate Sponsored" Research. Our Corporate Sponsored Research and investor meetings (e.g. NDRs, 1 to 1 meetings) are free to access and attend and is not classified as an inducement in a post-MiFID2 world, this is because the issuer is paying GPSL. GPSL does not offer any execution or market making services. This is a marketing communication as defined by the Financial Conduct Authority ("FCA"). The information herein is considered to be an acceptable minor non-monetary benefit as defined under FCA COBS 2.3A19(5).In accordance with the General Data Protection Regulation ("GDPR") - if you would like to be removed / unsubscribed from our CRM (also please note that you are free to contact GPSL at any time in the future to have your e-mail subscription amended), please e-mail:researchproduction@goetzpartners.comAbout GPSL: goetzpartners securities Limited is a member of the goetzpartners group, and a leading pan European investment bank and research company. We bring together a wide range of expertise, insights and innovations to advance the interests of our clients around the world. The fast-changing environment brings challenges for businesses and investors. Research innovation, digital transformation and disruptive business ideas reshuffle the corporate world at a relentless pace. Our sector knowledge and our global footprint bring together corporate intelligence and a deep understanding of the industry with a wide network of top decision makers. These collective insights help our clients to stay at the leading edge of change.This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients.This e-mail (including any attachments) from goetzpartners securities Limited ("GPSL") is confidential and may contain information which is proprietary, privileged or otherwise legally protected against unauthorised use or disclosure. If you receive this e-mail in error or are not the intended recipient of this e-mail, please delete and destroy all copies in your possession, notify the sender that you have received this e-mail, and note that any review or dissemination of, or the taking of any action in reliance on this e-mail is expressly prohibited. GPSL shall not be liable for the improper or incomplete transmission of the information contained in this e-mail nor for any delay in its receipt or damage to your system. GPSL does not guarantee that the integrity of this e-mail has been maintained nor that this e-mail is free of viruses, interceptions or interference and makes no warranties in relation to these matters. This is not an offer or a solicitation to buy or sell securities or investment products, or an official confirmation. GPSL record electronic and phone communications in accordance with FCA and MiFID2 regulations, they will be monitored for regulatory and training purposes. GPSL is authorised and regulated by the Financial Conduct Authority of the United Kingdom (firm reference number:225563).Click on the following link for the GPSL MiFID2 Investor Guidance NoticeGPSL Equity Research publications are available on the following aggregators and via news distribution circuits (For Institutional Use Only): AlphaSense, Bloomberg (GOET), Capital IQ, EQS, FACTSET, Research Tree, RNS Reach and Thomson Reuters.Please copy the below link and paste it into your browser for the full pdf version of the equity research report:https://gp.bluematrix.com/sellside/EmailDocViewer?encrypt=26b46358-9d60-4488-8ee3-4d544570c416&mime=pdf&co=gp&id=paul.dunne@goetzpartners.com&source=libraryViewFree to access research and investor meetings in a post-MiFID2 world.This research report is intended for use only by persons who qualify as professional investors or eligible counterparties (institutional investors) in the applicable jurisdiction, and not by any private individuals or other persons who qualify as retail clients.
Dissemination of a CORPORATE NEWS, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
728461 28-Sep-2018
Yep, I just checked the website. Sounds very promising. Many Thanks and hope they unveil all the best for us.
Never seen a board so quied and silent like this. Nothing to share? Anybody?
NEWS - Actinium Pharmaceuticals announces treatment of first patient in novel combination trial of actimab-A plus CLAG-M.
Fri Sep 21 01:11:16 2018 EDT
On 13 Jun 2018 , Actinium Pharmaceuticals Inc announced that the Medical College of Wisconsin has treated its first patient in a Phase 1 trial studying Actinium's Actimab-A in combination with CLAG-M for patients with relapsed or refractory (r/r) acute myeloid leukaemia (AML). This Phase 1 dose-escalation trial will study a single administration of Actimab-A following treatment of CLAG-M and will evaluate safety and tolerability, response rates, rates of bone marrow transplant (BMT), progression-free survival (PFS), and overall survival (OS). Actimab-A is an ARC or Antibody Radio-Conjugate comprised of the anti-CD33 monoclonal antibody lintuzumab labelled with the radioisotope actinium-225. CD33 is a marker expressed on AML cells of virtually all AML patients. Actinium's CD33 ARC has been studied in over 100 patients to date and is the only CD33 targeting agent being studied in a broad range of diseases in which the CD33 antigen is expressed including AML, myelodysplastic syndrome (MDS) and multiple myeloma. CLAG-M is a salvage chemotherapy regimen commonly used to treat patients with AML that consists of cladribine, cytarabine, filgrastim, and mitoxantrone. Original Source: Actinium Pharmaceuticals , 2018. Found on website: http://www.globenewswire.com.
SID(ELSEVIERdcc963b2901b9ae)
ATNM
CT/ebf CT/ebf.bus CT/ebf.bus.new CT/ebf.bus.new.pdt IC/hlth IC/hlth.phrm IC/svcs IC/svcs.educ II/biotech.immunoth II/hcare.biopharm II/hcare.biotech II/hcare.pharma IS/haw IS/haw.approval IS/haw.cancer IS/haw.disease IS/haw.drugapp IS/haw.drugs IS/haw.healthsc IS/haw.pharmdev IS/haw.reg IS/haw.treat
**CS-B-10
NEWS - Actinium Pharmaceuticals to Participate in the Oppenheimer & Co. Fall Summit Focused on Specialty Pharma and Rare Disease
Published: Sept 20, 2018 8:00 a.m. ET
NEW YORK, Sept. 20, 2018 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (nyse american:ATNM) today announced that the Company will participate in the Oppenheimer & Co. Fall Summit Focused on Specialty Pharma and Rare Disease, to be held September 26-27, 2018 in New York City. Management will be hosting one-on-one meetings at the conference as follows:
Date:
Thursday, September 27, 2018
Time:
8:00 am to 5:00 pm (ET)
Location:
The Langham Hotel, New York City
To schedule a meeting with Actinium, please contact Steve O'Loughlin, Principal Financial Officer via email soloughlin@actiniumpharma.com or through the Oppenheimer conference website https://www.opco.com/conferences/nypharma18/index.aspx.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for potentially superior targeted conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. The Company's targeted Antibody Radio-Conjugates (ARCs), combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium is developing a pipeline of clinical-stage ARCs targeting CD45 and CD33 for patients with a broad range of hematologic malignancies.
Iomab-B, Actinium's lead product candidate, is currently enrolling patients in a pivotal Phase 3 trial. Iomab-B combines the anti-CD45 monoclonal antibody BC8 labeled with iodine-131 and is designed to condition the bone marrow prior to a bone marrow transplant without the need for intense chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) of age 55 or older. Actinium's pipeline also includes a potentially best-in-class CD33 program with our ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in Phase 2 and Phase 1 clinical trials for patients with AML, myelodysplastic syndrome (MDS) and multiple myeloma.
Actinium is also developing its proprietary Actinium Warhead Enabling (AWE) technology platform to utilize the highly differentiated radioisotope actinium-225 with a wide range of targets. AWE is being utilized in a collaborative research partnership with Astellas Pharma, Inc.
More information is available at www.actiniumpharma.com and our Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contact:
Actinium Pharmaceuticals, Inc. Steve O'Loughlin
Principal Financial Officer
soloughlin@actiniumpharma.com
Investor Relations Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com
Susan A. Noonan
212-966-3650
investorrelations@actiniumpharma.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/actinium-pharmaceuticals-to-participate-in-the-oppenheimer--co-fall-summit-focused-on-specialty-pharma-and-rare-disease-300715908.html
SOURCE Actinium Pharmaceuticals, Inc.
Copyright (C) 2018 PR Newswire. All rights reserved
NEWS - PRESS RELEASE
Actinium Pharmaceuticals to Host Webinar Showcasing New Pipeline Initiative Focused on the CAR-T Space
Published: Sept 18, 2018 8:00 a.m. ET
- Conference call and webcast to be hosted by Management on Wednesday, September 26, 2018 at 4:15 PM ET- Dr. Nirav Shah, Assistant Professor of Medicine, Division of Hematology and Oncology at Froedtert & the Medical College of Wisconsin to discuss clinical relevance and strategy related to latest pipeline initiative
NEW YORK, Sept. 18, 2018 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (nyse american:ATNM) ("Actinium" or "the Company"), announced today that it will unveil a new clinical initiative that expands the Company's pipeline into the CAR-T space. CAR-T is a type of cellular therapy that genetically alters a patient's own T cells to target and kill their cancer cells. Currently, there are 2 approved CAR-T therapies for patients with certain B-cell cancers and over 200 CAR-T candidates in preclinical and clinical development for a wide range of hematologic and solid tumor indications. Actinium's management team along with Dr. Nirav Shah, Assistant Professor of Medicine, Division or Hematology and Oncology at Froedtert & the Medical College of Wisconsin will discuss the Companies latest pipeline initiative, its value proposition as applicable to CAR-T and the expected development pathway.
Dr. Shah said, "CAR-T is an exciting medical advancement that has demonstrated incredible promise in patients that need better treatment options and outcomes. The Froedtert & the Medical College of Wisconsin was an early adopter of CAR-T becoming one of the first FACT certified medical centers in the nation and commercial CAR-T sites, consistent with its pioneering of other techniques such as stem cell transplantation and immunotherapy. My colleagues and I, at the Froedtert & the Medical College of Wisconsin, are committed to continuing to advance the exciting field of CAR-T to further improve patient outcomes. I am excited by the potential of Actinium's next generation technology to further advance the field of CAR-T and look forward to providing more details on this potentially disruptive clinical initiative."
In addition to Dr. Shah, Sandesh Seth, Actinium's Chairman and CEO and Dr. Dale Ludwig, Actinium's Chief Scientific Officer will be on the call to discuss this new pipeline initiative. Participation details for the conference call and webcast are as follows:
Date:Wednesday, September 26, 2018
Time:4:15 PM ET
Webcast Registration:https://onecast.thinkpragmatic.com/ses/8JeRIX31t6pPlM3Dm85kJA~~
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831
"We are excited to be forging a path into CAR-T and are thrilled to be working with Dr. Shah and his colleagues at the Froedtert & Medical College of Wisconsin who have been pioneers in this field. We look forward to the contributions they will make to our next generation technology that we believe has great potential to advance access to CAR-T and patient outcomes'" said, Sandesh Seth, Actinium's Chairman and CEO. "I am incredibly motivated by this important pipeline expansion which has been enabled by the efforts of our new team and the potential growth opportunities it can provide for Actinium."
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for potentially superior targeted conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. The Company's targeted Antibody Radio-Conjugates (ARCs), combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium is developing a pipeline of clinical-stage ARCs targeting CD45 and CD33 for patients with a broad range of hematologic malignancies.
Iomab-B, Actinium's lead product candidate, is currently enrolling patients in a pivotal Phase 3 trial. Iomab-B combines the anti-CD45 monoclonal antibody BC8 labeled with iodine-131 and is designed to condition the bone marrow prior to a bone marrow transplant without the need for intense chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) of age 55 or older. Actinium's pipeline also includes a potentially best-in-class CD33 program with our ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in Phase 2 and Phase 1 clinical trials for patients with AML, myelodysplastic syndrome (MDS) and multiple myeloma.
Actinium is also developing its proprietary Actinium Warhead Enabling (AWE) technology platform to utilize the highly differentiated radioisotope actinium-225 with a wide range of targets. AWE is being utilized in a collaborative research partnership with Astellas Pharma, Inc.
More information is available at www.actiniumpharma.com and our Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contact:
Actinium Pharmaceuticals, Inc. Steve O'Loughlin
Vice President, Finance and Corporate Development
soloughlin@actiniumpharma.com
Investor Relations Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com
Susan A. Noonan
212-966-3650
investorrelations@actiniumpharma.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/actinium-pharmaceuticals-to-host-webinar-showcasing-new-pipeline-initiative-focused-on-the-car-t-space-300714317.html
SOURCE Actinium Pharmaceuticals, Inc.
Copyright (C) 2018 PR Newswire. All rights reserved
Good things take time. Continuously to success. I thought it was faster. Will take some time but I'm with ATNM.
Does anyone know when the next news will be announced? TIA
B.Riley FBR Maintains Their Buy Rating on Actinium Pharmaceuticals (ATNM)
Christine Brown-August 16, 2018, 11:50 AM EDT
https://www.smarteranalyst.com/brief/b-riley-fbr-maintains-their-buy-rating-on-actinium-pharmaceuticals-atnm/
Oppenheimer Maintains Their Buy Rating on Actinium Pharmaceuticals (ATNM)
Austin Angelo-August 16, 2018, 7:51 AM EDTSHARE ON:
In a report released today, Hartaj Singh from Oppenheimer maintained a Buy rating on Actinium Pharmaceuticals (NYSE: ATNM), with a price target of $5. The company’s shares closed yesterday at $0.62.
Singh wrote:
“Actinium Pharmaceuticals (ATNM) held a conference call this morning to update investors on the ongoing pivotal Phase 3 SIERRA study of Iomab-B in r/r AML. Management disclosed a positive DMC analysis following the 25% enrollment mark, and additional protocol amendments as a result of feedback from the clinical investigators. We believe these ongoing collaborative efforts with investigators will optimize SIERRA and reflect the underlying support of the physician/KOL community. This trial readout is expected by YE19, but could occur sooner. Changes to the protocol have strengthened the potential product profile and site operational dynamics. We update our model for 2Q18 financials and remain bullish.”