UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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Actinium Pharmaceuticals, Inc.
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 28, 2020
ACTINIUM
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36374
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74-2963609
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(State or other
jurisdiction
of incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.)
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275
Madison Avenue, 7th Floor, New York, NY 10016
(Address
of Principal Executive Offices)
Registrant’s
telephone number: (646) 677-3870
(Former
name or former address, if changed since last report)
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Securities
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of each class
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Trading
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Common Stock,
par value $0.001 per share
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ATNM
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NYSE American
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by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
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Item
7.01 Regulation FD Disclosure.
On
October 28, 2020 , Actinium Pharmaceuticals, Inc. (the “Company”) issued a letter to shareholders, which is attached
hereto as Exhibit 99.1. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit
99.1.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set
forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form
8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits
hereto, is material or that the dissemination of such information is required by Regulation FD.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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Actinium Pharmaceuticals,
Inc.
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Date: October 28, 2020
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/s/
Sandesh Seth
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Name: Sandesh Seth
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Title: Chairman and Chief Executive Officer
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Exhibit 99.1
October 2020
Dear Actinium Shareholder:
In 2020 thus far, we have made steady progress
with our Iomab-B SIERRA pivotal trial, which is in its final quartile of enrollment, and our Actimab-A combination trials in the
Relapsed and Refractory Acute Myeloid Leukemia (R/R AML) setting. We are on track and look forward to data updates related to this
progress by year-end; specifically, data from the first 75% of patients from the SIERRA trial, the Ad-Hoc interim analysis, and
POC data from our Actimab-A + CLAG-M combination trial. In addition, we have several other milestones across our platform that
will be reached in 4Q:2020 and 2021, setting the stage for a potentially transformational future for your company. We approach
these milestones with momentum across our clinical pipeline, enhanced R&D capabilities, a strong balance sheet and highly motivated
colleagues. We are excited for Actinium’s future, grateful for your support and look forward to creating value for all stakeholders.
Attractive Multi-Product, Multi-Indication
Opportunity in R/R AML Emerges in 2020
The progress made this year with Iomab-B
and the Actimab-A therapeutic combination trials is exciting and potentially transformational. Taken together these programs can
address the still unmet needs of a large segment of patients with R/R AML and potentially change the way the disease is treated.
Despite 9 approved therapies for AML, a majority of patients relapse or become refractory at which point treatment options are
limited. Bone Marrow Transplant (BMT) remains the only curative treatment option but R/R AML patients typically cannot receive
one as they are unable to withstand the highly toxic chemotherapy conditioning agents currently being used. As depicted in the
graphic below, the ongoing pivotal Phase 3 SIERRA trial with Iomab-B is the backbone for our R/R AML strategy; enabling elderly,
unfit patients to access a BMT with the potential for improved survival. Our Actimab-A combination trials with CLAG-M and venetoclax
could be used either as therapeutics or a bridge to transplant in the fit and unfit patient segments. We eagerly await the data
events for Iomab-B and the proof of concept data for both Actimab-A combination trials by year-end and in 2021, respectively. Together
these results could set the stage for a much larger and attractive opportunity in R/R AML than either drug candidate alone.
Upcoming Data Could Set Stage for
Expanded Market Opportunity in R/R AML
The R/R AML patient population is largely
treated in approximately 75-100 tertiary care hospitals, which also conduct the majority of BMT procedures. Leveraging relationships
established with the leading AML treatment centers in our clinical trials and our supply chain capabilities, we believe that Iomab-B
and Actimab-A could be successfully commercialized into the tertiary care setting and envision building Actinium into a specialty
oncology company focused on addressing the R/R AML patient population with multiple products. Our programs are on the cusp of producing
data that can help us realize this vision.
2020 – Accomplishments Across
All Major Pipeline Initiatives
As we hear of COVID-19 ad nauseum,
I am proud to report that Actinium was able to accomplish many of its clinical goals despite clinical sites being severely hampered
for several months. Our SIERRA trial was able to maintain enrollment because the trial investigators needed to keep treating very
sick R/R AML patients and recognized the demonstrated benefit of Iomab-B from the 50 percent interim analysis. Throughout this
period, dedicated teams at Actinium and our clinical sites were able to ensure that our supply chain capabilities were fully operational.
Highlighted below are some of the achievements we have made in 2020 and outlook into our major programs.
Targeted Conditioning Pipeline –
Value Creating Data Events Within Reach
Iomab-B Program for BMT - Pivotal Phase
3 SIERRA Trial
We note that, despite the late trial stage,
investigator interest driven by data updates published at the 50 percent mark has led to several additional sites joining or expected
to join the study. This data reported at the Transplantation & Cellular Therapy Conference showed that 100% of patients receiving
Iomab-B underwent a BMT and engrafted, the first sign of a successful BMT outcome. Only 18% of control arm patients successfully
received a BMT. Additionally, the difference in number of patients potentially evaluable for the primary endpoint, measured by
100-day non-relapse transplant related mortality, has remained consistent at roughly 6x greater for the study arm at the 25% and
50% enrollment updates. With the trial in its final quartile of enrollment, we look forward to data updates from the 75 percent
enrollment mark and the interim ad-hoc analysis by year-end. The strong investigator interest in Iomab-B is a barometer for the
unmet need and we are hopeful that Iomab-B will be able to provide these patients improved access to a BMT and better outcomes.
Iomab-ACT Program for CAR-T –
Proof of Concept Trial with MSK
We are collaborating with Memorial Sloan
Kettering Cancer Center (MSK) via an approach validating NIH STTR fast track grant to explore the benefit of using Iomab-ACT, a
low dose version of the ARC used in the Iomab-B program, to condition patients before they receive CAR-T therapy. MSK is a leader
in the field of cellular therapy and this trial is unique as it will be the first time an ARC has been used for conditioning for
any cellular therapy. The CAR-T construct, 19-28z, used in this trial, has proven efficacy in various blood cancers but is not
truly viable due to relatively high rates of cytokine release syndrome and neurotoxicity. Iomab-ACT can potentially address these
issues by selectively targeting and depleting immune cells implicated in these CAR-T toxicities and creating a better environment
for the CAR-T cells to expand and persist in order to attack the patient’s cancer and potentially have lower side effects
and higher and more durable responses. We look forward to proof of concept data from this trial in 2021. There is an attractive
and potentially large opportunity for the Iomab-ACT program to become the universal conditioning regimen for CAR-T based therapies.
Other Conditioning Programs –
Actimab-MDS and Iomab-ACT for Gene Therapy
We have completed our interactions with
FDA and have a clear pathway to a pivotal trial after a short dose confirming Phase 1 study (which we believe will likely be 4uCi/kg
body weight) for the Actimab-MDS targeted conditioning study in high-risk patients with MDS or myelodysplastic syndrome. The start
of the gene therapy trial in HIV related lymphoma has been delayed as the University of California Davis was severely impacted
due to COVID-19 and cohort expansion in the trial which uses chemotherapy conditioning, highlighting the need improved conditioning
regimens. We will update on these programs as they move ahead in 2021.
CD33 Program Revitalization Via Therapeutic
Combination Trials Data
Our CD33 program is showing compelling
promise and could become an important driver of value. Recall, through the Phase 2 trial, we demonstrated that single-agent Actimab-A
was extremely potent (ORR of 69%) and had no extramedullary toxicity outside of myelosuppression. We are parlaying this profile
via a therapeutic combination strategy with established agents in R/R AML. As very few patients are cured with the 9 approved drugs,
R/R AML patients account for almost 70% of the AML population. Each of our Actimab-A combination trials adds low, sometimes sub-therapeutic
doses of Actimab-A, to established doses of drugs or drug cocktails and delivers internalized radiation to a highly radiation sensitive
liquid cancer. There is also a mechanistic synergy or potentiating effect possible from adding Actimab-A in the two combination
trials with CLAG-M and venetoclax. Actimab-A, in addition to its single agent activity can damage certain proteins like Mcl-1 and
act in concert with DNA damage response inhibitor drugs and yield extremely high patient response rates without compromising their
safety.
Supporting our approach are data from the
Actimab-A + CLAG-M trial which showed a very high remission rate of 86%, 60% higher than CLAG-M alone. This second dose cohort
combined a sub-therapeutic dose of Actimab-A with a standard CLAG-M regimen. Further, the minimal residual disease or MRD negative
rate was an impressive 71%, which bodes well for durability of response. Venetoclax combinations are arguably the most widely prescribed
regimen but most patients ultimately fail, and our trial is attracting significant investigator interest which has led to site
expansion. We are excited as we believe these data events can demonstrate the immense value creating potential of our CD33 program,
which has been largely overshadowed by Iomab-B and is deserving of further attention. We look forward to presenting updated POC
data from our CLAG-M combination and first human data from the venetoclax combination Phase 1 trial by year-end.
Why Bolster R&D Capabilities at
Actinium?
Actinium the company, was formed two decades
ago to harness the power of radioisotopes, in particular Actinium-225 or Ac-225, to treat and potentially even cure cancer. The
idea was far ahead of its time and the company certainly had its share of vicissitudes…we are the sixth management team.
We restarted R&D three years ago, within a few months of our tenure, and have revitalized the aging patent portfolio, informed
CD45 and CD33 program expansion via our research and entered into a research partnership with a global biopharma company. We now
execute in a highly collaborative manner navigating complex scientific considerations, informed by commercial sensitivities, our
clinical know-how and supply chain expertise.
While no one has cured cancer, not even
with a radiotherapeutic since Actinium was formed, there have been certain high-profile successes with radiopharmaceuticals that
have created tremendous value for shareholders. This success has attracted new entrants and significant investments. Given a fortified
balance sheet and potential for significant value creating clinical milestones by year-end that could enable us to build a specialty
oncology company, we have begun stage 2 of our R&D plan. We have elected to develop internal laboratory capabilities to be
able to execute our plans more efficiently than using outside vendors. We believe that this internal R&D capability is essential
to attract collaborators, accelerate planned clinical programs and strengthen our competitive position as a leader in developing
Ac-225 based therapeutics.
We are proud of the progress we have made
in 2020 in the face of tough operating conditions and are excited for year-end clinical milestones that can set the stage for a
potentially transformative 2021. Our strong balance sheet, enhanced team and capabilities, position your company well for value
creation.
On behalf of our entire company and the
Board of Directors, I thank you for your commitment to Actinium Pharmaceuticals and supporting our mission to develop medicines
in areas where our product candidates can materially improve patient lives.
Sincerely,
/s/ Sandesh Seth
Sandesh Seth
Chairman and Chief Executive Officer
Key Achievements in 2020
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Key Upcoming Milestones
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Iomab-B mid-point analysis of SIERRA
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●Iomab-B SIERRA 75% patient data
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4Q:2020
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Exercised ad hoc analysis for SIERRA
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●Iomab-B SIERRA Ad Hoc Analysis
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4Q:2020
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Raised ~$60M in 1H:2020
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●Actimab-A CLAG-M POC
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4Q:2020
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Completed Phase 1 Actimab-A CLAG-M
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●Actimab-A Venetoclax 1st human data
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4Q:2020
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Initiated Actimab-A Venetoclax combo
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●Actimab-A Venetoclax POC
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2021
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Launched research facility
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●Iomab-ACT CD19 CAR-T POC
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2021
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Iomab-ACT CAR-T Collaboration
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●Actimab-A Gene Therapy update
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2021
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4
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