Filed Pursuant to Rule 424(b)(5)
Registration No. 333-216748
Prospectus Supplement
(To Prospectus Dated October 24, 2017)
Up to $32,500,000 of Common Stock and
4,229,091 Shares of Common Stock
This prospectus supplement relates to the issuance and sale of up to $32,500,000 of shares of our common
stock that we may issue to Lincoln Park Capital Fund, LLC (“Lincoln Park”) from time to time under a Purchase Agreement
that we entered into with Lincoln Park on October 18, 2018 (the “Purchase Agreement”), and an additional 852,537
shares of common stock that are being issued to Lincoln Park as a commitment fee for entering into the Purchase Agreement.
The shares offered include:
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3,376,554
shares of common stock that Lincoln Park is purchasing as an initial purchase under
the Purchase Agreement on the date of this prospectus supplement, at a purchase price
of $0.74 per share and a total gross purchase price of $2,500,000;
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up to $30,000,000 of shares of common stock we may sell to Lincoln Park after the initial purchase from
time to time, at our sole discretion, in accordance with the Purchase Agreement; and
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852,537 shares of common stock being issued to Lincoln Park as commitment shares in consideration for entering into the Purchase
Agreement, valued at $0.76 per share. We will not receive any cash proceeds from the issuance of these commitment shares.
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This prospectus supplement and the accompanying
prospectus also cover the resale of these shares by Lincoln Park to the public.
Our common stock trades on the NYSE American under the symbol “ATNM.” On October 17, 2018,
the last reported sales price of our common stock on the NYSE American was $0.74 per share.
Investing in the common stock involves
risks. See “Risk Factors” beginning on page S-6 of this prospectus supplement.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of
this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is
October 18, 2018
Table of Contents
About this Prospectus Supplement
This document is in two parts. The first
part is this prospectus supplement, which describes the specific terms of this offering. The second part, the accompanying prospectus,
provides more general information, some of which may not apply to this offering. This prospectus supplement and the information
incorporated by reference in this prospectus supplement also adds to, updates and changes information contained or incorporated
by reference in the accompanying prospectus. If information in this prospectus supplement or the information incorporated by reference
in this prospectus supplement is inconsistent with the accompanying prospectus or the information incorporated by reference therein,
then this prospectus supplement or the information incorporated by reference in this prospectus supplement will apply and will
supersede the information in the accompanying prospectus and the documents incorporated by reference therein.
This prospectus supplement is part of a
registration statement that we filed with the Securities and Exchange Commission (the “SEC”), using a “shelf”
registration process. Under the shelf registration process, we may from time to time offer and sell any combination of the securities
described in the accompanying prospectus up to a total dollar amount of $200,000,000 of which this offering is a part.
You should rely only on the information
contained or incorporated by reference in this prospectus supplement or the accompanying prospectus. We have not authorized anyone
to provide you with different or additional information. If anyone provides you with different or additional information, you should
not rely on it. We are not making an offer of these securities under any circumstance or in any jurisdiction where the offer is
not permitted or unlawful. You should assume that the information contained in this prospectus supplement and the accompanying
prospectus is accurate only as of their respective dates, and that any information in documents that we have incorporated by reference
is accurate only as of the date of the document incorporated by reference.
This prospectus supplement, the accompanying
prospectus and the information incorporated herein and therein by reference include trademarks, service marks and trade names owned
by us or other companies. All trademarks, service marks and trade names included or incorporated by reference into this prospectus
supplement or the accompanying prospectus are the property of their respective owners.
Unless the context otherwise requires,
references in this prospectus supplement to “we”, “us” and “our” refer to Actinium Pharmaceuticals,
Inc.
Prospectus
Supplement Summary
This summary highlights selected information
about our company, this offering and information appearing elsewhere in this prospectus supplement, in the accompanying prospectus,
in the documents we incorporate by reference and in any free writing prospectus that we have authorized for use in connection with
this offering. This summary is not complete and does not contain all the information that you should consider before investing
in our securities. You should read this entire prospectus supplement and the accompanying prospectus carefully, including the “Risk
Factors” contained in this prospectus supplement, the accompanying prospectus and the financial statements and the notes
thereto incorporated by reference in this prospectus supplement and the accompanying prospectus and any free writing prospectus
that we have authorized for use in connection with this offering, before making an investment decision. This prospectus supplement
may add to, update or change information in the accompanying prospectus.
Description of Business
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, targeted conditioning technology that can be used either without
chemotherapy or reduced amounts or chemotherapy. 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.
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
unhindered pre-commercial and early commercial development.
Corporate and Other Information
We were organized in the State of Nevada in October 1997 and
reorganized in the State of Delaware in March 2013. Our principal executive offices are located at 275 Madison Avenue, 7th
Floor, New York, New York 10016. Our telephone number is (646) 677-3870. Our website address is www.actiniumpharma.com. Information
accessed through our website is not incorporated into this prospectus supplement and is not a part of this prospectus supplement
or the accompanying prospectus.
The Offering
Issuer
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Actinium Pharmaceuticals, Inc.
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Securities being Offered
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3,376,554 shares
of common stock that Lincoln Park is purchasing as an initial purchase under the Purchase Agreement on the date of this prospectus
supplement, at a purchase price of $0.74 per share and a total gross purchase price of $2,500,000;
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up
to $30,000,000 of shares of common stock we may sell to Lincoln Park after the initial purchase from time to time, at our
sole discretion, in accordance with the Purchase Agreement; and
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852,527 shares of common stock being issued to Lincoln Park as commitment shares in consideration for entering into the
Purchase Agreement, valued at $0.76 per share. We will not receive any cash proceeds from the issuance of these commitment shares.
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Shares of common stock to be outstanding immediately after this offering
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Up to 132,551,726 shares common stock, assuming an average sales price of $0.74 per share (the last reported sales price of our common stock on the NYSE American on October 17, 2018) for the remaining $30,000,000 of shares of common stock we may sell to Lincoln Park after the initial purchase from time to time, including 3,376,554 shares of common stock that Lincoln Park is purchasing as an initial purchase and 852,527 shares of common stock being issued to Lincoln Park as commitment shares in consideration for entering into the Purchase Agreement. The actual number of shares issued and outstanding will vary depending on the sale prices of shares sold to Lincoln Park in this offering.
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Use of Proceeds
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We currently intend to use the net proceeds from the sale of securities offered by this prospectus
supplement to complete our ongoing pivotal, Phase 3 SIERRA trial for our lead product candidate Iomab-B and progress Phase 1
trials from our refocused CD33 program to the proof of concept stage. We will also use the proceeds to support our AWE
Technology Platform including our Iomab-ACT program, research and development and general working capital needs. See
“Use of Proceeds” in the prospectus supplement.
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Risk Factors
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Investing in our common shares and involves a high degree of risk. For a discussion of factors that you should consider before buying our securities, see the information under “Risk Factors” in this prospectus supplement and under similar headings in the documents incorporated by reference into this prospectus supplement.
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NYSE American symbol
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“ATNM.”
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(1)
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The
Purchase Agreement prohibits us from issuing or selling to Lincoln Park under the Purchase Agreement (i) in excess of 22,082,743
shares of our common stock (the “Exchange Cap”), unless we obtain stockholder approval to issue shares in excess of
the Exchange Cap or the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement
equal or exceed the greater of book or market value of the common stock as calculated in accordance with the applicable rules
of the NYSE American, and (ii) any shares of our common stock if those shares, when aggregated with all other shares of our common
stock then beneficially owned by Lincoln Park and its affiliates would result in Lincoln Park and its affiliates having beneficial
ownership of more than 9.99% of the then total outstanding shares of our common stock (the “Beneficial Ownership Cap”).
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Agreement with Lincoln Park Capital Fund, LLC
On October 18, 2018, we entered into a Purchase
Agreement with Lincoln Park, pursuant to which, upon the terms and subject to the conditions and limitations set forth therein,
we have the right to sell to Lincoln Park up to $32,500,000 of shares of our common stock (including the initial purchase of $2,500,000
of our common stock at our discretion as described below.
Pursuant to the Purchase Agreement, in an
initial purchase on October 18, 2018, Lincoln Park purchased 3,376,554 shares (the “Initial Purchase Shares”) of our
common stock, at a price of $0.74 per share, for a total gross purchase price of $2,500,000 (the “Initial Purchase”).
As consideration for entering into the Purchase Agreement, we issued 852,537 shares of our common stock to Lincoln Park as a commitment
fee (the “Commitment Shares”). We will not receive any cash proceeds from the issuance of the Commitment Shares.
We are filing this prospectus supplement to cover the offer and sale of (i) up to $32,500,000 of shares
of our common stock, which consists of (a) 3,376,554 Initial Purchase Shares that Lincoln Park purchased in the Initial Purchase
for a total gross purchase price of $2,500,000, and (b) additional shares of common stock with an aggregate offering price
of up to $30,000,000, which we may sell from time to time in our sole discretion to Lincoln Park, subject to the conditions and
limitations in the Purchase Agreement, and (ii) the 852,537 Commitment Shares.
In addition to the Initial Purchase, as
often as every business day from and after one business day following the date of the Initial Purchase and over the 30-month term
of the Purchase Agreement on which the closing price of our common stock is at least $0.15 (the “Floor Price”), and
up to an aggregate amount of an additional $30,000,000 (subject to certain limitations) of shares of Common Stock, we have the
right, from time to time, in our sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 400,000
shares (the “Regular Purchase Share Limit”) of our common stock (each such purchase, a “Regular Purchase”).
The Regular Purchase Share Limit will increase to (a) 500,000 shares, if the closing price of our common stock on the purchase
date is not below $0.50, and (b) 600,000 shares, if the closing price of our common stock on the purchase date is not below $0.75.
In any case, Lincoln Park’s maximum obligation under any single Regular Purchase will not exceed $1,500,000, unless we mutually
agree to increase the maximum amount of such Regular Purchase. The purchase price for shares of common stock to be purchased
by Lincoln Park under a Regular Purchase will be the equal to lesser of:
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the
closing sale price for our common stock on the purchase date; and
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the
arithmetic average of the three lowest closing sale prices for our common stock during the ten trading days prior to the purchase
date.
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If we direct Lincoln Park to purchase
the maximum number of shares of common stock we then may sell in a Regular Purchase, then in addition to such Regular Purchase,
and subject to subject to certain conditions and limitations in the Purchase Agreement, we may direct Lincoln Park to make an “accelerated
purchase” of an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased
pursuant to the corresponding Regular Purchase and (ii) 30% of the total number of shares of our common stock traded during a specified
period on the applicable purchase date as set forth in the Purchase Agreement. The purchase price for such shares will be the lesser
of:
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the
closing sale price for the common stock on the date of sale; and
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97%
of the volume weighted average price of the common stock over a certain portion of the date of sale as set forth in the Purchase
Agreement.
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Under certain circumstances and in accordance
with the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same
trading day.
We will control the timing and amount of any sales of our common stock to Lincoln Park. There is no upper
limit on the price per share that Lincoln Park must pay for our common stock under the Purchase Agreement, but in no event will
shares be sold to Lincoln Park on a day closing price of our common stock is less than the Floor Price.
The Purchase Agreement also prohibits us
from directing Lincoln Park to purchase any shares of common stock if those shares, when aggregated with all other shares of our
common stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having
beneficial ownership, at any single point in time, of more than 9.99% of the then total outstanding shares of our common stock.
The Purchase Agreement does not limit our
ability to raise capital from other sources at our sole discretion, except that (subject to certain exceptions) we may not enter
into any variable rate transaction (as defined in the Purchase Agreement, including the issuance of any floating conversion rate
or variable priced equity-like securities) during the 30 months after the date of the Purchase Agreement.
Events of default under the Purchase Agreement
include the following:
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the
effectiveness of the registration statement, of which this prospectus supplement and accompanying prospectus are a part, lapses
for any reason (including, without limitation, the issuance of a stop order), or this prospectus supplement and accompanying prospectus
are unavailable for sale by us or the resale by Lincoln Park of our common stock offered hereby, and such lapse or unavailability
continues for a period of ten consecutive business days or for more than an aggregate of thirty business days in any 365-day period;
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the
suspension of our common stock from trading or the failure of our common stock to be listed on the NYSE American for a period
of one business day;
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the
delisting of our common stock from NYSE American; provided, however, that our common
stock is not immediately thereafter trading on the New York Stock Exchange, the NASDAQ
Capital Market, the NASDAQ Global Market, the NASDAQ Global Select Market, the
NYSE Arca, the OTC Bulletin Board or OTC Markets (or nationally recognized successor
to any of the foregoing);
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the
failure for any reason by the transfer agent to issue the securities offered hereby to
Lincoln Park within three business days after the applicable purchase date which Lincoln
Park is entitled to receive such securities;
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any
breach of the representations and warranties or covenants contained in the Purchase Agreement or any related agreements with Lincoln
Park if such breach would reasonably be expected to have a material adverse effect and such breach is not cured within five trading
days;
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our
participation in insolvency or bankruptcy proceedings by or against us, as more fully described in the Purchase Agreement; or
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if
at any time we are not eligible to transfer our common stock electronically via DWAC.
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Lincoln Park does not have the right to
terminate the Purchase Agreement upon any of the events of default set forth above. During an event of default, all of which are
outside the control of Lincoln Park, shares of our common stock cannot be sold by us or purchased by Lincoln Park under the terms
of the Purchase Agreement.
We may at any time, in our sole discretion,
terminate the Purchase Agreement without fee, penalty or cost, upon one trading day written notice. In the event of bankruptcy
proceedings by or against us, the Purchase Agreement will automatically terminate without action of any party.
The above description of the Purchase
Agreement is qualified in its entirety by reference to the Purchase Agreement, which will be filed with the SEC and incorporated
by reference into this prospectus supplement.
Amount of Additional Potential Proceeds to be Received under
the Purchase Agreement
Under the Purchase
Agreement, we may sell shares of common stock having an aggregate offering price of up to an additional $30.0 million to Lincoln
Park from time to time following the Initial Purchase. The number of shares ultimately offered for sale to Lincoln Park in this
offering is dependent upon the number of shares we elect to sell to Lincoln Park under the Purchase Agreement. The following table
sets forth the amount of proceeds we would receive from Lincoln Park from the sale of shares at varying purchase prices:
Assumed Average
Purchase Price
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Additional Proceeds from
the Sale of
Shares Under
the Purchase
Agreement
Registered in
this Offering
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Number of Shares
to be Issued in this
Offering at the
Assumed Average
Purchase Price (1)
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Percentage of
Outstanding Shares
After Giving Effect
to the Additional Purchased
Shares Issued to
Lincoln Park (2)
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$
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0.50
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$
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8,926,846.00
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17,853,692
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(3)
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16.7
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%
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$
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1.00
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$
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17,853,692
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17,853,692
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(3)
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16.7
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%
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$
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2.00
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$
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30,000,000.00
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15,000,000
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14.8
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%
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$
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3.00
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$
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30,000,000.00
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10,000,000
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11.4
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%
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(1)
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Includes
the total number of Purchase Shares (but not Commitment Shares or Initial Purchase Shares) which we would have sold under the
Purchase Agreement at the corresponding assumed purchase price set forth in the adjacent column, up to the additional aggregate
purchase price of $30,000,000.
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(2)
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The denominator is based on
110,468,953 shares outstanding as of October 17, 2018, the 852,537 shares previously issued to Lincoln Park, the 3,376,554
shares of common stock that Lincoln Park is purchasing as an initial purchase, and the number of shares set forth in the
adjacent column which we would have sold to Lincoln Park. The numerator is based on the additional number of shares which we
may issue to Lincoln Park under the Purchase Agreement (that are the subject of this offering) at the corresponding assumed
purchase price set forth in the adjacent column, the 852,537 shares previously issued to Lincoln Park, and the 3,376,554 shares of common stock
that Lincoln Park is purchasing as an initial purchase.
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(3)
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The Purchase Agreement prohibits us from issuing or selling
to Lincoln Park under the Purchase Agreement (i) shares of our common stock in excess of the Exchange Cap, unless we obtain
stockholder approval to issue shares in excess of the Exchange Cap or the average price of all applicable sales of our common
stock to Lincoln Park under the Purchase Agreement equal or exceed the greater of book or market value of the Common Stock as
calculated in accordance with the applicable rules of the NYSE American, and (ii) any shares of our common stock if those shares,
when aggregated with all other shares of our common stock then beneficially owned by Lincoln Park and its affiliates, would exceed
the Beneficial Ownership Cap.
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Risk Factors
An investment in our securities involves
a high degree of risk. Prior to making a decision about investing in our securities, you should carefully consider the specific
factors discussed below, together with all of the other information contained or incorporated by reference in this prospectus supplement
and the accompanying prospectus, including in our Annual Report on Form 10-K and any updates described in our Quarterly Reports
on Form 10-Q or other documents filed by us with the SEC. It is not possible to predict or identify all such risks. Consequently,
we could also be affected by additional factors that are not presently known to us or that we currently consider to be immaterial
to our operations.
We will have broad discretion in the use of the net proceeds
from this offering and may not use them effectively.
Our management will have broad discretion
in the application of the proceeds from this offering and could spend the proceeds in ways that do not necessarily improve our
results of operations or enhance the value of our common stock. Our failure to apply these funds effectively could have a material
adverse effect on our business, financial condition, operating results and cash flow, and could cause the price of our common stock
to decline.
If we sell shares of our common stock under the Purchase
Agreement, our existing stockholders will experience immediate dilution and, as a result, our stock price may go down.
Pursuant to the Purchase Agreement, we have agreed to sell $2,500,000 of shares of common stock to Lincoln
Park as the Initial Purchase, up to an additional $30,000,000 shares of common stock over a 30-month period at our option and subject
to certain limitations, and 852,537 shares of common stock as consideration for Lincoln Park’s commitment to enter into Purchase
Agreement. For additional details on this financing arrangement, please refer to “Plan of Distribution” located elsewhere
in this prospectus supplement. The sale of shares of our common stock pursuant to the Purchase Agreement will have a dilutive impact
on our existing stockholders. Lincoln Park may resell some or all of the shares we issue to it under the Purchase Agreement and
such sales could cause the market price of our common stock to decline, which decline could be significant.
We do not currently intend to pay dividends on our common
stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.
At the present time, we intend to use available
funds to finance our operations. Accordingly, while payments of dividends rests within the discretion of our board of directors,
we have not paid any cash dividends on our common shares and we have no intention of paying any such dividends in the foreseeable
future. Any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.
Special Note Regarding Forward-Looking
Statements
This prospectus supplement and accompanying
prospectus and the information incorporated by reference in this prospectus supplement and accompanying prospectus contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), which include information relating to future events, future
financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,”
“could,” “would,” “predicts,” “potential,” “continue,” “expects,”
“anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,”
and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements
should not be read as a guarantee of future performance or results and will probably not be accurate indications of when such performance
or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our
management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties
that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements. Important factors that could cause such differences include, but are not limited to:
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our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
regarding the adequacy of our liquidity to pursue our complete business objectives;
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our ability to complete clinical trials as anticipated and obtain and maintain regulatory approvals for our products;
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our ability to adequately protect our intellectual property;
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disputes over ownership of intellectual property;
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our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary;
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the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our
products are an attractive alternative to other procedures and products;
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intense competition in our industry, with competitors having substantially greater financial, technological, research and development,
regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
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entry of new competitors and products and potential technological obsolescence of our products;
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loss of a key customer or supplier;
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adverse economic conditions;
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adverse federal, state and local government regulation, in the United States;
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price increases for supplies and components;
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inability to carry out research, development and commercialization plans; and
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loss or retirement of key executives and research scientists.
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Although we believe that the forward-looking
statements contained herein are reasonable, we can give no assurance that our expectations will be met. All forward-looking statements
contained herein are expressly qualified in their entirety by this cautionary statement and the risk factors beginning on page
S-6 of this prospectus supplement.
You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of this prospectus supplement. Except to the extent required
by applicable laws and regulations, we undertake no obligation to update these forward-looking statements to reflect events or
circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.
Dilution
The purchaser of common stock in this offering
will experience an immediate dilution of the net tangible book value per share of our common stock. Our net tangible book value
as of June 30, 2018 was approximately $17.3 million, or $0.23 per share of our common stock based upon 110,458,121 shares of
our common stock outstanding. Net tangible book value per share is equal to our total tangible assets less our total liabilities,
divided by the number of shares of our outstanding common stock.
Dilution per share of common stock equals
the difference between the amount per share of common stock paid by the purchaser of common stock in this offering and the net
tangible book value per share of our common stock immediately after the offering.
After giving effect to the sale by us
of 22,082,773 shares of common stock at the offering price of approximately $0.74 per share of common stock, and after
deducting estimated offering expenses, our pro forma net tangible book value as of June 30, 2018 would have been
approximately $33.6 million, or $0.25 per share. This represents an immediate increase in pro forma net tangible book
value to existing stockholders of $0.09 per share and an immediate dilution to the purchaser of $(0.49) per share. The
following table illustrates this per-share dilution:
Offering price per share of common stock
|
|
|
|
|
|
$
|
0.74
|
|
Net tangible book value per share as of June 30, 2018
|
|
$
|
0.16
|
|
|
|
|
|
Increase in net tangible book value per share attributable to offering
|
|
$
|
0.09
|
|
|
|
|
|
Pro forma net tangible book value per share as of June 30, 2018, after giving effect to offering
|
|
|
|
|
|
$
|
0.25
|
|
Dilution in net tangible book value
per share to the purchaser in the offering
|
|
|
|
|
|
$
|
(0.49
|
)
|
The number of shares of our common stock that will be outstanding
immediately after the offering is based on 110,458,121 shares outstanding as of June 30, 2018, and excludes:
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●
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5,800,742 shares of common stock issuable upon the
exercise of stock options outstanding as of June 30, 2018 under our equity incentive plans, with a weighted average exercise price
of $2.06 per share;
|
|
●
|
11,347,594 shares of common stock available for future
grants under our equity incentive plans as of June 30, 2018;
|
|
●
|
238,908 shares of restricted stock reserved for
issuance as of June 30, 2018; and
|
|
●
|
56,015,610 shares of common stock issuable upon
the exercise of warrants outstanding as of June 30, 2018, with a weighted average exercise price of $1.23 per share.
|
Use of Proceeds
We estimate the net proceeds from this offering
will be approximately $16.3 million after deducting our estimated offering expenses.
We currently intend to use the net proceeds from the sale of securities offered by this prospectus supplement
to complete our ongoing pivotal, Phase 3 SIERRA trial for our lead product candidate Iomab-B and progress Phase 1 trials from our
refocused CD33 program to the proof of concept stage. We will also use the proceeds to support our AWE Technology Platform including
our Iomab-ACT program, research and development efforts and general working capital needs.
Investors are cautioned,
however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of our management,
who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing of our actual
expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount of competition
and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this offering for other
purposes.
From time to time, we evaluate these and
other factors and we anticipate continuing to make such evaluations to determine if the existing allocation of resources, including
the proceeds of this offering, is being optimized. Circumstances that may give rise to a change in the use of proceeds include:
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●
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a change in development plan or strategy;
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|
●
|
the addition of new products or applications;
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|
●
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delays or difficulties with our clinical trials;
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|
●
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negative results from our clinical trials;
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|
●
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difficulty obtaining U.S. Food and Drug Administration
approval;
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|
●
|
failure to achieve sales as anticipated; and
|
|
●
|
the availability of other sources of cash including
cash flow from operations and new bank debt financing arrangements, if any.
|
Pending other uses, we intend to invest
the proceeds to us in investment-grade, interest-bearing securities such as money market funds, certificates of deposit, or direct
or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether the proceeds invested will yield a
favorable, or any, return.
Plan of Distribution
This prospectus supplement and the accompanying prospectus relate to the issuance and sale of up to $32,500,000
of shares of our common stock that we may issue to Lincoln Park from time to time under a Purchase Agreement that we entered into
with Lincoln Park on October 18, 2018, and an additional 852,537 shares of common stock that are being issued to Lincoln Park as
Commitment Shares for entering into the Purchase Agreement. This prospectus supplement and the accompanying prospectus also cover
the resale of these shares by Lincoln Park to the public.
Pursuant to the Purchase Agreement, in the Initial Purchase, Lincoln Park is purchasing 3,376,554 shares
of our common stock, at a price of $0.74 per share, for a total gross purchase price of $2,500,000. As often as every business
day from and after one business day following the date of the Initial Purchase and over the 30-month term of the Purchase Agreement
on which the closing price of our common stock is at least the Floor Price, and up to an aggregate amount of an additional $30,000,0000
(subject to certain limitations) of shares of our common stock, we have the right, from time to time, in our sole discretion and
subject to certain conditions, to direct Lincoln Park to purchase up to 400,000 shares of Common Stock in a Regular Purchase, with
such amount increasing as the closing sale price of the Common Stock increases; provided Lincoln Park’s obligation under
any single Regular Purchase will not exceed $1,500,000, unless we and Lincoln Park mutually agree to increase the maximum amount
in such Regular Purchase.
If we direct Lincoln Park to purchase the
maximum number of shares of common stock we then may sell in a Regular Purchase, then in addition to such Regular Purchase, and
subject to certain conditions and limitations in the Purchase Agreement, we may direct Lincoln Park to make an “accelerated
purchase” of an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased
pursuant to the corresponding Regular Purchase and (ii) 30% of the total number of shares of our common stock traded during a specified
period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with
the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same trading
day.
We will control the timing and amount of
any sales of our common stock to Lincoln Park. There is no upper limit on the price per share that Lincoln Park must pay for our
common stock under the Purchase Agreement, but in no event will shares be sold to Lincoln Park on a day our closing price is less
than the Floor Price.
As consideration for entering into the
Purchase Agreement, the Company issued to Lincoln Park 852,537 shares of Common Stock. The Company will not receive any cash proceeds
from the issuance of these shares.
We may at any time, in our sole discretion
terminate the Purchase Agreement without fee, penalty or cost, upon one trading day written notice. In the event of bankruptcy
proceedings by or against us, the Purchase Agreement will automatically terminate without action of any party.
We
may suspend the sale of shares to Lincoln Park pursuant to this prospectus supplement for certain periods of time for certain reasons,
including if this prospectus supplement is required to be supplemented or amended to include additional material information.
Lincoln Park is an “underwriter”
within the meaning of Section 2(a)(11) of the Securities Act. Lincoln Park has informed us that it will use an unaffiliated broker-dealer
to effectuate all sales, if any, of the common stock that it may purchase from us pursuant to the Purchase Agreement. Such sales
will be made on the NYSE American at prices and at terms then prevailing or at prices related to the then current market price.
Each such unaffiliated broker-dealer will be an underwriter within the meaning of Section 2(a)(11) of the Securities Act. Lincoln
Park has informed us that each such broker-dealer will receive commissions from Lincoln Park that will not exceed customary brokerage
commissions.
We know of no existing arrangements between
Lincoln Park and any other stockholder, broker, dealer, underwriter, or agent relating to the sale or distribution of the shares
offered by this Prospectus. At the time a particular offer of shares is made, a prospectus supplement, if required, will be distributed
that will set forth the names of any agents, underwriters, or dealers and any compensation from the selling stockholder, and any
other required information.
We will pay all of the expenses incident
to the registration, offering, and sale of the shares to Lincoln Park.
We have agreed to indemnify Lincoln Park
and certain other persons against certain liabilities in connection with the offering of shares of common stock offered hereby,
including liabilities arising under the Securities Act or, if such indemnity is unavailable, to contribute amounts required to
be paid in respect of such liabilities.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling
persons, we have been advised that in the opinion of the SEC this indemnification is against public policy as expressed in the
Securities Act and is therefore, unenforceable.
Lincoln Park represented to us that at
no time prior to the date of the Purchase Agreement has Lincoln Park or its agents, representatives or affiliates engaged in or
effected, in any manner whatsoever, directly or indirectly, any short sale (as such term is defined in Rule 200 of Regulation SHO
of the Exchange Act) of our common stock or any hedging transaction. Lincoln Park agreed that during the term of the Purchase Agreement,
it, its agents, representatives or affiliates will not enter into or effect, directly or indirectly, any of the foregoing transactions.
We have advised Lincoln Park that it is
required to comply with Regulation M promulgated under the Exchange Act. With certain exceptions, Regulation M precludes the selling
stockholder, any affiliated purchasers, and any broker-dealer or other person who participates in the distribution from bidding
for or purchasing, or attempting to induce any person to bid for or purchase any security which is the subject of the distribution
until the entire distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price
of a security in connection with the distribution of that security. All of the foregoing may affect the marketability of the shares
offered by this prospectus supplement.
The transfer agent and registrar for our
common stock is Action Stock Transfer Corporation.
Legal Matters
The validity of the securities offered by this prospectus will
be passed upon for us by The Matt Law Firm, PLLC, Utica, New York.
Experts
The financial statements incorporated in this prospectus supplement
by reference to the Annual Report on Form 10-K for the fiscal years ended December 31, 2017 and 2016 have been so incorporated
in reliance on the report of GBH CPAs, PC an independent registered public accounting firm, given on the authority of said firm
as experts in auditing and accounting.
Where You Can Find More Information
We are subject to the informational requirements
of the Securities Exchange Act of 1934, as amended, and in accordance therewith file annual, quarterly and current reports, proxy
statements and other information with the Securities and Exchange Commission. Such reports, proxy statements and other information
can be read and copied at the Securities and Exchange Commission’s public reference facilities at 100 F Street, N.E., Washington,
D.C. 20549, at prescribed rates. Please call the Securities and Exchange Commission at 1-800-732-0330 for further information on
the operation of the public reference facilities. In addition, the Securities and Exchange Commission maintains a website that
contains reports, proxy and information statements and other information regarding registrants that file electronically with the
Securities and Exchange Commission. The address of the Securities and Exchange Commission’s website is www.sec.gov.
We make available free of charge on or through
our website at www.actiniumpharmceuticals.com, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934, as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it
to the Securities and Exchange Commission.
We have filed with the Securities and Exchange
Commission a registration statement under the Securities Act of 1933, as amended, relating to the offering of these securities.
The registration statement, including the attached exhibits, contains additional relevant information about us and the securities.
This prospectus supplement does not contain all of the information set forth in the registration statement. You can obtain a copy
of the registration statement, at prescribed rates, from the Securities and Exchange Commission at the address listed above, or
for free at www.sec.gov. The registration statement and the documents referred to below under “Incorporation of Certain Information
By Reference” are also available on our website, www.actiniumpharmaceuticals.com.
We have not incorporated by reference into
this prospectus supplement the information on our website, and you should not consider it to be a part of this prospectus supplement.
Incorporation of Certain Information
by Reference
The Securities and Exchange Commission allows
us to “incorporate by reference” the information we have filed with it, which means that we can disclose important
information to you by referring you to those documents. The information we incorporate by reference is an important part of this
prospectus supplement, and later information that we file with the Securities and Exchange Commission will automatically update
and supersede this information. We incorporate by reference the documents listed below and any future documents (excluding information
furnished pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the Securities and Exchange Commission pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, subsequent to the date of this prospectus supplement
and prior to the termination of the offering:
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Our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission
on March 16, 2018;
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Our Quarterly Report on Form 10-Q for the three months ended March 31, 2018, filed with the Securities and Exchange Commission
on May 10, 2018 and our Quarterly Report on Form 10-Q for the three months ended June 30, 2018, filed with the Securities and Exchange
Commission on August 9, 2018;
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Our Current Reports on Form 8-K filed with the Securities and Exchange Commission on May 1, 2018 and August 15, 2018; and
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●
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The description of our common stock, which is contained in our Form 8-K/A, filed with the Securities and Exchange Commission
on January 28, 2013.
|
All filings filed by us pursuant to the
Securities Exchange Act of 1934, as amended, after the date of the initial filing of this registration statement and prior to the
effectiveness of such registration statement (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) shall
also be deemed to be incorporated by reference into the prospectus supplement.
You should rely only on the information
incorporated by reference or provided in this prospectus supplement. We have not authorized anyone else to provide you with different
information. You should not assume that the information in this prospectus supplement is accurate as of any date other than the
date of this prospectus supplement or the date of the documents incorporated by reference in this prospectus supplement.
We will provide without charge to each person
to whom a copy of this prospectus supplement is delivered, upon written or oral request, a copy of any or all of the information
that has been incorporated by reference in this prospectus supplement but not delivered with this prospectus supplement (other
than an exhibit to these filings, unless we have specifically incorporated that exhibit by reference in this prospectus supplement).
Any such request should be addressed to us at: 275 Madison Avenue, 7th Floor, New York, New York 10016, Attention: Steve O’Loughlin,
Principal Financial Officer, or made by phone at (646) 677-3875. You may also access the documents incorporated by reference in
this prospectus supplement through our website at www.actinium pharmaceuticals.com. Except for the specific incorporated documents
listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus supplement
or the accompanying prospectus.
PROSPECTUS
ACTINIUM
PHARMACEUTICALS, INC.
$200,000,000
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Rights
Purchase
Contracts
Units
We
may offer and sell from time to time, in one or more series or issuances and on terms that we will determine at the time of the
offering, any combination of the securities described in this prospectus, up to an aggregate amount of $200,000,000.
We
will provide specific terms of any offering in a supplement to this prospectus. Any prospectus supplement may also add, update,
or change information contained in this prospectus. You should carefully read this prospectus and the applicable prospectus supplement
as well as the documents incorporated or deemed to be incorporated by reference in this prospectus before you purchase any of
the securities offered hereby.
These
securities may be offered and sold in the same offering or in separate offerings; to or through underwriters, dealers, and agents;
or directly to purchasers. The names of any underwriters, dealers, or agents involved in the sale of our securities, their compensation
and any over-allotment options held by them will be described in the applicable prospectus supplement. See “Plan of Distribution.”
Our
common stock is presently traded on the NYSE American under the symbol “ATNM.” On October 23, 2017, the last reported
sale price of our common stock was $0.72 per share. We recommend that you obtain current market quotations for our common stock
prior to making an investment decision. We will provide information in any applicable prospectus supplement regarding any listing
of securities other than shares of our common stock on any securities exchange.
You
should carefully read this prospectus, any prospectus supplement relating to any specific offering of securities, and all information
incorporated by reference herein and therein.
Investing in our securities involves a high degree of risk. These risks are discussed in this prospectus
under “Risk Factors” beginning on page 8 and in the documents incorporated by reference into this prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is October 24, 2017
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission using a “shelf”
registration process. Under this shelf process, we may, from time to time, sell any combination of the securities described in
this prospectus in one or more offerings up to a total amount of $200,000,000.
This
prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide
a prospectus supplement that will contain specific information about the terms of that offering. The prospectus supplement may
also add to, update or change information contained in the prospectus and, accordingly, to the extent inconsistent, information
in this prospectus is superseded by the information in the prospectus supplement.
The
prospectus supplement to be attached to the front of this prospectus may describe, as applicable: the terms of the securities
offered; the public offering price; the price paid for the securities; net proceeds; and the other specific terms related to the
offering of the securities.
You
should only rely on the information contained or incorporated by reference in this prospectus and any prospectus supplement or
issuer free writing prospectus relating to a particular offering. No person has been authorized to give any information or make
any representations in connection with this offering other than those contained or incorporated by reference in this prospectus,
any accompanying prospectus supplement and any related issuer free writing prospectus in connection with the offering described
herein and therein, and, if given or made, such information or representations must not be relied upon as having been authorized
by us. Neither this prospectus nor any prospectus supplement nor any related issuer free writing prospectus shall constitute an
offer to sell or a solicitation of an offer to buy offered securities in any jurisdiction in which it is unlawful for such person
to make such an offering or solicitation. This prospectus does not contain all of the information included in the registration
statement. For a more complete understanding of the offering of the securities, you should refer to the registration statement,
including its exhibits.
You
should read the entire prospectus and any prospectus supplement and any related issuer free writing prospectus, as well as the
documents incorporated by reference into this prospectus or any prospectus supplement or any related issuer free writing prospectus,
before making an investment decision. Neither the delivery of this prospectus or any prospectus supplement or any issuer free
writing prospectus nor any sale made hereunder shall under any circumstances imply that the information contained or incorporated
by reference herein or in any prospectus supplement or issuer free writing prospectus is correct as of any date subsequent to
the date hereof or of such prospectus supplement or issuer free writing prospectus, as applicable. You should assume that the
information appearing in this prospectus, any prospectus supplement or any document incorporated by reference is accurate only
as of the date of the applicable documents, regardless of the time of delivery of this prospectus or any sale of securities. Our
business, financial condition, results of operations and prospects may have changed since that date.
PROSPECTUS
SUMMARY
This
summary provides an overview of selected information contained elsewhere or incorporated by reference in this prospectus and does
not contain all of the information you should consider before investing in our securities. You should carefully read the prospectus,
the information incorporated by reference and the registration statement of which this prospectus is a part in their entirety
before investing in our securities, including the information discussed under “Risk Factors” in this prospectus and
the documents incorporated by reference and our financial statements and notes thereto that are incorporated by reference in this
prospectus. As used in this prospectus, unless the context otherwise indicates, the terms “we,” “our,”
“us,” or “the Company” refer to Actinium Pharmaceuticals, Inc., a Delaware corporation, and its subsidiaries
taken as a whole.
The
Company
Business
Overview
We are a clinical-stage biopharmaceutical
company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant (BMT) and for the targeting and killing of cancer cells. We are currently conducting clinical
trials for our three product candidates, Iomab-B, Actimab-A and Actimab-M, as well as performing research on other potential drug
candidates utilizing our proprietary alpha-particle technology platform. Our most advanced product candidate, Iomab-B, is
comprised of an anti-CD45 monoclonal antibody labeled with iodine-131 (I-131). We are currently conducting a pivotal Phase 3 trial
of Iomab-B for myeloablation and conditioning of the bone marrow prior to a bone marrow transplant for patients with relapsed or
refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow transplant is a potentially curative treatment option for
patients with AML and other blood cancers including leukemias, lymphomas and multiple myeloma as well as certain blood disorders.
Upon successful completion of our Phase 3 clinical trial for Iomab-B we intend to submit for marketing approval in the U.S. and
European Union. Our most advanced alpha-particle based therapy, Actimab-A, is an anti-CD33 monoclonal antibody conjugated with
the alpha-particle actinium-225 (Ac-225). Actimab-A is currently in a Phase 2 clinical trial for patients over the age of
60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy. Actimab-M, our third product candidate,
is the same anti-CD33 monoclonal antibody conjugated to Ac-225 but a different dose and dosing regimen. Actimab-M, is being
studied in a Phase 1 trial for patients with refractory multiple myeloma. We expect our alpha-particle technology platform will
generate additional drug candidates that we will progress in clinical trials ourselves and or out-license. We intend to develop
a number of products for numerous types of cancer and derive revenue from partnering relationships worldwide and/or direct sales
of our products primarily in the United States.
In December 2015, we announced that the U.S.
Food and Drug Administration, or FDA, cleared our IND filing for Iomab-B. In June 2016, we announced the pivotal Phase 3 clinical
trial for Iomab-B was initiated, and assuming that the trial meets its end points, it will form the basis for a Biologics Licensing
Application (BLA). We established an agreement with the FDA that the path to a BLA submission would include a single, pivotal Phase
3 clinical study if it is successful. The population in this two arm, randomized, controlled, multicenter trial will be patients
with relapsed or refractory AML over the age of 55. The trial size was set at 150 patients with 75 patients per arm. The primary
endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least six months
and the secondary endpoint will be overall survival at one year. We believe there are currently no effective treatments approved
by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed several physicians-sponsored
clinical trials examining its potential as a myeloconditioning regimen prior to BMT in various blood cancers, including the Phase
1/2 study in relapsed and/or refractory AML patients. The results of these studies in over 300 patients have demonstrated the potential
of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do
not have any viable treatment options currently; enabling a shorter and safer preparatory interval for BMT; reducing post-transplant
complications; and showing a clear survival benefit including curative potential.
In September 2016, we initiated a Phase 2
clinical trial for Actimab-A. This Phase 2 clinical trial is a multicenter, open-label study that will enroll 53 patients. Patients
will receive 2.0 µCi/kg/fractionated dose of Actimab-A via two injections given at day 1 and day 7. The Phase 2 trial is
designed to evaluate complete response rates at up to day 42 after Actimab-A administration, including complete remission (CR),
complete remission with incomplete platelet recovery (CRp) or complete remission with incomplete blood count recovery (CRi) A formal
interim analysis is scheduled for 31 patients, which is expected by the end of 2017. The Phase 2 clinical trial includes peripheral
blast burden as an inclusion criteria and in patients with high peripheral blast (PB) burden, the use of Hydroxyurea will be mandated
with the goal of bringing peripheral blasts below 200/µL, which we identified from two previously complete Phase 1 clinical
trials totaling 38 patients. In addition, the use of granulocyte colony-stimulating factors (GCSF) will be mandated. Low dose cytarabine
has been eliminated from the protocol and the Phase 2 clinical trial will evaluate Actimab-A as a monotherapy. The secondary endpoint
of the Phase 2 clinical trial will be overall survival.
In February 2017, we initiated a Phase 1
investigator initiated clinical trial to study Actimab-M in multiple myeloma. Multiple myeloma is a cancer of plasma cells that
is currently incurable. The Phase 1 trial will enroll up to 12 patients with relapsed or refractory multiple myeloma who have positive
CD33 expression. This Phase 1 study is designed as a dose escalation study intended to assess safety, establish maximum tolerable
dose (MTD) and assess efficacy. Patients will be administered Actimab-M on day 1 at an initial dose of 0.5 µCi/kg and then
assessed at day 42 for safety and efficacy. The dose can be increased to 1.0 µCi/kg or reduced to 0.25 µCi/kg based
on safety assessment that will evaluate dose limiting toxicities (DLTs). Patients may receive up to 8 cycles of therapy but in
no event will cumulative administration exceed 4.0 µCi/kg of Actimab-M.
Business Strategy
We intend to develop our most advanced clinical
stage candidate, Iomab-B, through approval and if these efforts are successful, we may elect to commercialize Iomab-B on our own
or with a partner in the United States and/or outside of the United States to out-license the rights to develop and commercialize
the product to a strategic partner. We intend to develop Actimab-A and Actimab-M through Phase 2 proof of concept human clinical
trial (a trial designed to provide data on the drug’s efficacy) and we will most likely seek to enter into strategic partnerships
whereby the strategic partner(s) co-fund(s) further human clinical trials of the drug that are needed to obtain regulatory approvals
for commercial sale within and outside of the United States. In parallel, we intend to identify and begin initial human trials
with additional actinium-225 based product candidates in other cancer indications. We intend to retain marketing rights for our
products in the United States whenever possible and out-license marketing rights to our partners for the rest of the world. We
may also seek to in-license other applicable opportunities should such technology become available.
Market Opportunity
We compete in the marketplace for cancer
treatments estimated to reach over $83 billion in 2016 sales, according to “The Global Use of Medicines: Outlook Through
2016 Report by the IMS Institute for Healthcare Informatics, July 2012.” While surgery, radiation and chemotherapy remain
staple treatments for cancer, their use is limited by the fact that they often cause substantial damage to normal cells. On the
other hand, targeted monoclonal antibody therapies exert most or all of their effect directly on cancer cells, but often lack sufficient
killing power to eradicate all cancer cells with just the antibody. A new approach for treating cancer is to combine the precision
of antibody-based targeting agents with the killing power of radiation or chemotherapy by attaching powerful killing agents to
precise molecular carriers called monoclonal antibodies (mAb). We use mAbs labeled with radioisotopes to deliver potent doses of
radiation directly to cancer cells while sparing healthy tissues. The radioisotopes we use are the alpha emitter Ac-225 and the
beta emitter I-131. I-131 is among the best known and well characterized radioisotopes. It is used very successfully in treatment
of papillary and follicular thyroid cancer as well as other thyroid conditions. It is also attached to a monoclonal antibody in
treatment of Non-Hodgkin’s Lymphoma (“NHL”) and is also used experimentally with different carriers in other
cancers. Ac-225 has many unique properties and we believe we are a leader in developing this alpha emitter for clinical applications
using our proprietary alpha particle technology.
Our most advanced products are Iomab-B, I-131
labeled anti-CD45 mAb for myeloablation of relapsed or refractory AML patients pripr to a BMT and Actimab-A, Ac-225 conjugated
to an anti-CD33 mAb for treatment of newly diagnosed AML, in patients ineligible for currently approved therapies. We recently
began clinical development of Actimab-M, Ac-225 conjugated to an anti-CD33 mAb for the treatment of patients with refractory multiple
myeloma.Iomab-B offers a potentially curative treatment for these patients, most of whom do not survive beyond one year after being
diagnosed with this condition. Iomab-B has also demonstrated efficacy in BMT preparation for other blood cancer indications, including
myelodysplastic syndrome (“MDS”), acute lymphoblastic leukemia (“ALL”), Hodgkin’s Lymphoma, multiple
myeloma and NHL. These are all follow-on indications for which Iomab-B can be developed and it is our intention to explore these
opportunities at a future date. We believe the aggregate worldwide market potential for the treatment of AML, MDS, ALL, Hodgkin’s
Lymphoma, multiple myeloma and NHL is approximately $4.1 billion.
In December 2015, we announced that the FDA
cleared our IND filing for Iomab-B, and that we proceeded with a pivotal, Phase 3 clinical trial. We anticipate the Phase 3, controlled,
randomized, pivotal trial will complete enrollment of patients by 2018 and assuming that the trial meets its endpoints, it will
form the basis for a BLA. We, in our recently approved IND filing, established an agreement with the FDA that the path to a BLA
submission would include a single, pivotal Phase 3 clinical study if it is successful. The population in this two arm, randomized,
controlled, multicenter trial will be refractory and relapsed AML patients over the age of 55. The trial size was set at 150 patients
with 75 patients per arm. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete
remission lasting at least six months and the secondary endpoint will be overall survival at one year. There are currently no effective
treatments approved by the FDA for AML in this patient population and there is no defined standard of care. Iomab-B has completed
several physicians sponsored clinical trials examining its potential as a conditioning regimen prior to BMT in various blood cancers,
including the Phase 1/2 clinical trial in relapsed and/or refractory AML patients. The results of these clinical trials in over
300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding
the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory
interval for BMT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.
Other potential product opportunities in
which significant preclinical work is being undertaken include metastatic colorectal cancer, metastatic prostate cancer and antiangiogenesis
which reduces the blood supply to solid tumors. We believe the worldwide market potential for the treatment of metastatic colorectal
cancer is approximately $4.8 billion, and we believe the worldwide market potential for the treatment of metastatic prostate cancer
is approximately $6.0 billion. We also believe the worldwide market potential for the treatment of Glioblastoma Multiforme, a potential
indication based on an antiangiogenesis approach, is approximately $1.1 billion. We estimate the market potential for these indications
based on company research, published rates of disease incidence and company calculations based on costs of currently used therapies.
We believe that our biggest market opportunity
lies in the applicability of our alpha particle technology platform to a wide variety of cancer indications. A broad range of solid
and blood borne cancers can be potentially targeted by mAbs to enable treatment with the alpha-particle technology. We believe
that our alpha-particle technology could potentially be applied to mAbs that are already approved by the FDA to create more efficacious
and/or safer drugs (“biobetters”).
In March 2016, the FDA granted orphan drug
designation for Iomab-B and in October 2016 the European Medicines Agency (EMA) granted orphan designation in the European Union
(EU) for Iomab-B. In November 2014, the FDA granted orphan-drug designation for Actimab-A and in May 2017 the EMA granted orphan
designation in the EU for Actimab-A. The FDA, through its Office of Orphan Products Development, grants orphan status to drugs
and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders
that affect fewer than 200,000 people in the United States. Orphan drug designation provides a drug developer with certain benefits
and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication;
potential tax credits on United States clinical trials; eligibility for orphan drug grants; and waiver of certain administrative
fees. The EMA, through its Committee for Orphan Medicinal Products (COMP), examines applications for orphan designation. To qualify
for orphan designation, the prevalence of the condition must be less than 5 in 10,000, it must be life-threatening or chronically
debilitating and there must be no satisfactory method of treating the condition. Sponsors who obtain orphan designation receive
numerous incentives including protocol assistance, a reduction or waving of fees and 10 years of market exclusivity should the
therapy be approved.
Clinical Trials
Iomab-B
Iomab-B is our lead product candidate currently
in a pivotal Phase 3 multicenter clinical trial. It consists of the anti-CD45 monoclonal antibody BC8 and beta emitting radioisotope
iodine 131 (I-131). The indication for that trial is bone marrow conditioning for BMT in patients with relapsed and refractory
AML over the age of 55.
Previous Iomab-B clinical trials leading
to the Phase 3 trial included:
Indications
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N
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Key Findings
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AML, MDS, ALL (adult)
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34
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–7/34 patients with median disease free state (DFS) of 17 years.
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–18/34 patients in remission at day 80
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AML >1st remission (adult)
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23
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–15/23 in remission at day 28
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AML 1st remission (age 16-50)
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43
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–23/43 DFS from 5-16 years
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–30/43 in remission at day 28
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–33/43 in remission at day 80
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High-risk MDS, advanced AML
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68 in dose escalation study
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–CR (complete remission) in all patients
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(age 50+)
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31 treated at MTD
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–1 yr survival ~40% for all patients
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–1 yr survival ~45% for pts treated at MTD maximum tolerated dose)
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High-risk MDS, AML
(age 18–50)
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14 in dose escalation
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All patients achieved full donor chimerism by day 28 post-transplant
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High-risk MDS, AML
–haploidentical donors (adult)
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8 in dose escalation
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–6/8 treated patients achieved CR by day 28
–8/8 patients 100% donor chimerism by day 28
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Ongoing Iomab-B clinical trials include:
Indications
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Phase
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Relapsed and refractory Hodgkin Lymphoma and NHL (adult)
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Phase 1
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Advanced AML, ALL and MDS (adult)
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Phase 2
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AML 1st remission (age 16-50)
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Phase 2
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High-risk MDS, advanced AML (age 16-50)
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Phase 2
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There are additional ongoing clinical trials
with BC8 antibody labeled with yttrium 90 (Y-90).
Phase 3 Iomab-B clinical trial:
We obtained FDA’s comment and guidance
on the Iomab-B Phase 3 clinical trial design, and the FDA identified the following design features as generally acceptable, dependent
on the results of the trial:
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Single pivotal study, pending trial results;
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Patient population: refractory AML patients age of 55 and older, where refractory is defined as either primary failure to achieve a complete remission after 2 cycles of induction therapy; relapsed after 6 months in complete remission; second or higher relapse; or relapsed disease not responding to intensive salvage therapy;
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Trial arms: study arm and control arm with physician’s choice of conventional care with curative intent; and
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Trial size: 150 patients total (75 patients per arm).
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Actimab-A
Actimab-A is currently in the Phase 2 portion
of a multicenter Phase 1/2 clinical trial in AML. It consists of the anti-CD33 monoclonal antibody Lintuzumab and alpha emitting
radioisotope actinium 225 (Ac-225). The indication in the ongoing trial is patients newly diagnosed with AML over the age of 60
that are ineligible for standard induction chemotherapy.
Previous clinical trials leading to this
trial included:
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Phase 1 clinical trial with Bismab-A, the first generation product consisting of the same anti-CD33 monoclonal antibody Lintuzumab and Bi-213 alpha emitter, a daughter of Ac-225;
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Phase 1/2 clinical trial with Bismab-A, the first generation product consisting of the same monoclonal antibody Lintuzumab and Bi-213 alpha emitter, a daughter of Ac-225; and
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Dose escalating pilot Phase 1 clinical trial with Actimab-A, the current product consisting of the Lintuzumab monoclonal antibody and Ac-225 alpha emitter.
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Completed Actimab-A related clinical trials
outcomes:
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The Phase 2 arm of the Bismab-A drug study has shown signs of the drug’s efficacy and safety, including reduction in peripheral blast counts and complete responses in some patients. Bi-213 is a daughter, i.e., product of the degradation of Ac-225, with cancer cell killing properties similar to Ac-225 but is less potent. The Phase 1 Actimab-A trial at MSKCC with a single-dose administration of Actimab-A showed elimination of leukemia cells from blood in 67% of all evaluable patients who received a full dose and in 83% of those treated at dose levels above 0.5 microcuries per kilogram (µCi/kg), and eradication of leukemia cells in both blood and bone marrow in 20% of all evaluable patients and 25% of those treated at dose levels above 0.5 µCi/kg. Maximum tolerated single dose in this trial was established at 3 µCi/kg.
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High potency means that a relatively low
amount of drug is needed to produce a given effect. In preclinical and Phase 1 clinical studies, Actimab-A (
225
Ac-lintuzumab)
has demonstrated at least 500-1000 times higher potency than the first-generation predecessor (
213
Bi-lintuzumab) upon
which it is based. This difference is due to intrinsic physicochemical properties of Actimab-A that were first established
in
vitro
, in which Actimab-A killed multiple cell lines at doses at least 1000 times lower (based on LD50 values) than Bismab-A
analogs. Key factors in Actimab-A’s higher potency are the yield of 4 alpha-emitting isotopes per
225
Ac (compared
to 1 alpha decay for bismuth 213) and much longer half-life (10 day for
225
Ac vs 46 minutes for
213
Bi).
In preclinical animal models, doses in the
nanocurie range prolonged survival. In humans, Actimab-A was previously studied in a Phase I monotherapy trial of relapsed or refractory
AML patients at MSKCC. Dose levels in that study re-confirmed the substantially higher potency of Actimab-A, as compared to equivalent
dosing of the first-generation Bismab-A (
213
Bi-lintuzumab) construct, which had nevertheless established safety and
efficacy in a Phase 1/2 trial in high-risk AML with cytoreduction.
Sources: Jurcic JG. Targeted Alpha-Particle
Immunotherapy with Bismuth-213 and Actinium-225 for Acute Myeloid Leukemia. J. Postgrad Med Edu Res 2013, 47(1):14-17; ; JG Jurcic
et al, Phase 1 Trial of the Targeted Alpha- Particle Nano-Generator Actinium-225 (225Ac)-Lintuzumab in Acute Myeloid Leukemia (AML)
J Clin Oncol 29:2011 (suppl, abstr 6516); McDevitt MR et al, “Tumor Therapy with Targeted Atomic Nanogenerators” Science
2001, 294:1537—1540; Rosenblat TL et al, “Sequential cytarabine and alpha-particle immunotherapy with bismuth- 213-lintuzumab
(HuM195) for acute myeloid leukemia” Clin Cancer Res. 2010, 16(21):5303-5311; Jurcic JG et al. “Phase I Trial of the
Targeted Alpha-Particle Nano-Generator Actinium-225 (225Ac)-Lintuzumab in Acute Myeloid Leukemia (AML)” Blood (ASH Meeting
Abstracts) 2012.
Ongoing Actimab-A trial:
We have completed the Phase 1 portion of
our first company sponsored Phase 1/2 multi-center trial with fractionated (two) doses of Actimab-A, for the treatment of patients
newly diagnosed with AML over the age of 60. Actimab-A consists of an anti-CD33 monoclonal antibody (HuM195, also known as Lintuzumab)
and the actinium 225 radioactive isotope attached to it. Results from the Phase 1 portion of the trial showed that 28% (5 of 18)
of patients had objective responses (2CR, 1CRp and 2 CRi (complete remission with incomplete blood count recovery)) with median
response duration of 9.1 months. Mean bone marrow blast reduction amongst evaluable patients (14 of 18) was 67% with 57% of patients
having bone marrow blast reduction of 50% or greater and 79% (11 of 14) of patients having bone marrow blast reductions after Cycle
1 of therapy. Maximum tolerated dose (MTD) was not reached in this trial. We have elected to progress to the Phase 2 portion of
the trial at 2.0 μCi/kg/fraction, the highest dose level from the Phase 1 portion of the clinical trial.
The Phase 2 portion of the trial will enroll
53 patients and will study Actimab-A as a monotherapy. We received agreement from the FDA for multiple revisions to the protocol
for the Phase 2 portion of the clinical trial that include:
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Removing the use of low dose cytarabine from the Phase 2 protocol;
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Stipulating Peripheral blast burden as an inclusion criteria with blasts of 200/ML being the threshold;
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Mandating the use of hydroxyurea in patients with peripheral blast count above 200/ML to lower their peripheral blasts below 200ML/ prior to Actimab-A administration; and
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Mandating the use of granulocyte colony-stimulating factor (GCSF) support.
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Bismab-A trials and the Phase 1 Actimab-A trial were focused on relapsed, refractory and other difficult
to treat acute myeloid leukemia patients. The current Actimab-A multicenter Phase 1/2 trial is focused on patients newly diagnosed
AML who have historically had better outcomes.
Intellectual
Property
We have developed or in-licensed numerous patents
and patent applications and possess substantial know-how and trade secrets relating to the development and manufacturing of our
products. As of October 12, 2017, our patent portfolio includes: 68 issued and pending patent applications, of which 10 are issued
in the United States, 15 are pending in the United States, and 53 are issued internationally and pending internationally. Additionally,
several non-provisional patent applications are expected to be filed in 2018 based on provisional patent applications filed in
2017. This is part of an ongoing strategy to continue to strengthen our intellectual property position. About one quarter of our
patents are in-licensed from third parties and the remainder are Actinium owned. These patents cover key areas of our business,
including use of the actinium-225 and other alpha emitting isotopes attached to cancer specific carriers like monoclonal antibodies,
methods for manufacturing key components of our product candidates including actinium-225, the alpha emitting radioisotope and
carrier antibodies, and methods for manufacturing finished product candidates for use in cancer treatment.
We have licensed the rights to two issued patents in the area of drug preparation for methods of making
humanized antibodies for our product Actimab-A that will expire in 2018 and 2019, respectively. We own three issued patents and
one pending patent in the United States and thirty-two patents outside of the United States related to the manufacturing of actinium
in a cyclotron that will expire in 2027. We own or have licensed the rights to four issued patents and 1 pending patent in the
United States and twenty-one patents outside of the United States related to the generation of radioimmunoconjugates that will
expire in 2021, 2030 and 2032. We own or have licensed the rights to use one issued patent, one pending patent and two provisional
patents for methods of treatment with our product Actimab-A that will expire in 2019. For Iomab-B we own one pending patent
for anti-CD45 immunoglobulin composition and one pending patent the administration of a conjugated antibody.
A patent whose claims address methods of treating hematopoietic malignancies with Iomab-B is pending;
still, we have developed a proprietary strategy based on trade secret protection and the potential for orphan drug and data exclusivities.
The BC8 antibody, cell line and related know-how has been exclusively licensed by us from the Fred Hutchinson Cancer Research Center
(FHCRC) in exchange for milestone payments, royalties and research support.
Patents related to the antibody component of Actimab-A have been exclusively licensed by us from AbbVie
Biotherapeutics Corp. for use with alpha-emitting radioisotopes in exchange for future development and commercialization milestones,
a royalty on net sales for a period of 12.5 years from first commercial sale, a negotiation right to be our clinical and/or commercial
antibody supplier, a negotiation right to co-promote Actimab-A in the United States on terms to be negotiated, and the grant-back
of intellectual property (IP) rights covering improvements to the antibody for use other than with an alpha-emitting isotope. Patents
covering actinium-225 conjugated to antibodies have been exclusively licensed by us from MSKCC in exchange for license fees, research
support payments, development milestone payments, 2% royalties on net sales for the term of the licensed patents or, if later,
10 years from first commercial sale, and 15% of any sublicense income we may receive. We source actinium-225 under an agreement
with the Oak Ridge National Laboratory (ORNL) that expires at the end of 2017. We believe, but cannot guarantee, that we will be
able to renew this contract for additional annual periods.
Corporate
and Other Information
We
were organized in the State of Nevada on October 6, 1997 and reorganized in the State of Delaware on March 20, 2013. Our principal
executive offices are located at 275 Madison, 7
th
Floor, New York, New York 10016. Our telephone number is (646) 677-3870.
Our website address is www.actiniumpharma.com. Information accessed through our website is not incorporated into this
prospectus and is not a part of this prospectus.
The
Securities We May Offer
The
descriptions of the securities contained in this prospectus, together with the applicable prospectus supplements, summarize the
material terms and provisions of the various types of securities that we may offer. We will describe in the applicable prospectus
supplement relating to any securities the particular terms of the securities offered by that prospectus supplement. If we so indicate
in the applicable prospectus supplement, the terms of the securities may differ from the terms we have summarized below. We will
also include information in the prospectus supplement, where applicable, about material U.S. federal income tax considerations
relating to the securities, and the securities exchange, if any, on which the securities will be listed.
We
may sell from time to time, in one or more primary offerings, our common stock, preferred stock, debt securities, warrants, rights,
purchase contracts or units, or any combination of the foregoing.
In
this prospectus, we refer to the common stock, preferred stock, debt securities, warrants, rights, purchase contracts or units,
or any combination of the foregoing securities to be sold by us in a primary offering collectively as “securities.”
The total dollar amount of all securities that we may issue under this prospectus will not exceed $200,000,000.
This
prospectus may not be used to consummate a sale of securities unless it is accompanied by a prospectus supplement.
RISK
FACTORS
An
investment in our securities involves a high degree of risk. The prospectus supplement applicable to each offering of our securities
will contain a discussion of the risks applicable to an investment in our securities. Before deciding whether to invest in our
securities, you should carefully consider the specific factors discussed under the heading “Risk Factors” in the applicable
prospectus supplement, together with all of the other information contained or incorporated by reference in the prospectus supplement
or appearing or incorporated by reference in this prospectus. You should also consider the risks, uncertainties and assumptions
discussed under Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the fiscal year ended December 31,
2016, all of which are incorporated herein by reference, as updated or superseded by the risks and uncertainties described under
similar headings in the other documents that are filed after the date hereof and incorporated by reference into this prospectus
and any prospectus supplement related to a particular offering. The risks and uncertainties we have described are not the only
ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect
our operations. Past financial performance may not be a reliable indicator of future performance, and historical trends should
not be used to anticipate results or trends in future periods. If any of these risks actually occurs, our business, business prospects,
financial condition or results of operations could be seriously harmed. This could cause the trading price of our common stock
to decline, resulting in a loss of all or part of your investment. Please also read carefully the section below entitled “Special
Note Regarding Forward-Looking Statements.”
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus, each prospectus supplement and the information incorporated by reference in this prospectus and each prospectus supplement
contain “forward-looking statements,” which include information relating to future events, future financial performance,
strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,”
“would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,”
“future,” “intends,” “plans,” “believes,” “estimates,” and similar
expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not
be read as a guarantee of future performance or results and will probably not be accurate indications of when such performance
or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our
management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties
that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements. Important factors that could cause such differences include, but are not limited to:
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our history of recurring losses and negative
cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity
to pursue our complete business objectives;
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our ability to complete clinical trials as anticipated
and obtain and maintain regulatory approvals for our products;
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our ability to adequately protect our intellectual
property;
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disputes over ownership of intellectual property;
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the risk that the data collected from our current
and planned clinical trials may not be sufficient to demonstrate that our products is an attractive alternative to other products;
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intense competition in our industry, with competitors
having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing
and sales, distribution and personnel resources than we do;
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entry of new competitors and products and potential
technological obsolescence of our products;
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loss of a key customer or supplier;
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technical problems with our research and products
and potential product liability claims;
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adverse economic conditions;
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adverse federal, state and local government
regulation, in the United States;
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price increases for supplies;
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inability to carry out research, development
and commercialization plans; and
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loss or retirement of key executives and research
scientists.
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You
should review carefully the section entitled “Risk Factors” beginning on page 8 of this prospectus for a
discussion of these and other risks that relate to our business and investing in our securities. The forward-looking
statements contained or incorporated by reference in this prospectus or any prospectus supplement are expressly qualified in
their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking
statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence
of unanticipated events.
USE
OF PROCEEDS
Unless otherwise indicated in the prospectus supplement, we currently intend to use the net proceeds from
the sale of securities offered by this prospectus for general corporate purposes, including the advancement of our drug candidates
in clinical trials, such as Iomab-B, Actimab-A and Actimab-M, research and development of our alpha particle technology
platform, preclinical trials, and to meet working capital needs.
Investors
are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of
our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing
of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount
of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this
offering for other purposes.
From
time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing
allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change
in the use of proceeds include:
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a change in development plan or strategy;
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the addition of new products or applications;
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technical delays;
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delays or difficulties with our clinical trials;
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negative results from our clinical trials;
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difficulty obtaining U.S. Food and Drug Administration
approval; and
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the availability of other sources of cash including
additional offerings, if any.
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DESCRIPTION
OF CAPITAL STOCK
The
following description of common stock and preferred stock summarizes the material terms and provisions of the common stock and
preferred stock that we may offer under this prospectus, but is not complete. For the complete terms of our common stock and preferred
stock, please refer to our certificate of incorporation, as amended and our bylaws, as may be amended from time to time. While
the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer, we will
describe the specific terms of any series of preferred stock in more detail in the applicable prospectus supplement. If we so
indicate in a prospectus supplement, the terms of any preferred stock we offer under that prospectus supplement may differ from
the terms we describe below.
We
have authorized 250,000,000 shares of capital stock, par value $0.001 per share, of which 200,000,000 are shares of common stock
and 50,000,000 are shares of preferred stock. On October 11, 2017, there were 79,380,158 shares of common stock issued and outstanding
and no shares of preferred stock issued and outstanding. The authorized and unissued shares of common stock and the authorized
and undesignated shares of preferred stock are available for issuance without further action by our stockholders, unless such
action is required by applicable law or the rules of any stock exchange on which our securities may be listed. Unless approval
of our stockholders is so required, our board of directors does not intend to seek stockholder approval for the issuance and sale
of our common stock or preferred stock.
We
also have warrants that are outstanding, which are described below.
Common
Stock
The
holders of our common stock are entitled to one vote per share. Our certificate of incorporation does not provide for cumulative
voting. Our directors are divided into three classes. At each annual meeting of stockholders, directors elected to succeed those
directors whose terms expire are elected for a term of office to expire at the third succeeding annual meeting of stockholders
after their election. The holders of our common stock are entitled to receive ratably such dividends, if any, as may be declared
by our board of directors out of legally available funds; however, the current policy of our board of directors is to retain earnings,
if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of our common stock are entitled to
share ratably in all assets that are legally available for distribution. The holders of our common stock have no preemptive, subscription,
redemption or conversion rights. The rights, preferences and privileges of holders of our common stock are subject to, and may
be adversely affected by, the rights of the holders of any series of preferred stock, which may be designated solely by action
of our board of directors and issued in the future.
Our
common stock is listed on the NYSE American under the symbol “ATNM.”
Preferred
Stock
The
board of directors is authorized, subject to any limitations prescribed by law, without further vote or action by the stockholders,
to issue from time to time shares of preferred stock in one or more series. Each such series of preferred stock shall have such
number of shares, designations, preferences, voting powers, qualifications, and special or relative rights or privileges as shall
be determined by the board of directors, which may include, among others, dividend rights, voting rights, liquidation preferences,
conversion rights and preemptive rights. Issuance of preferred stock by our board of directors may result in such shares having
dividend and/or liquidation preferences senior to the rights of the holders of our common stock and could dilute the voting rights
of the holders of our common stock.
Prior
to the issuance of shares of each series of preferred stock, the board of directors is required by the Delaware General Corporation
Law and our certificate of incorporation to adopt resolutions and file a certificate of designation with the Secretary of State
of the State of Delaware. The certificate of designation fixes for each class or series the designations, powers, preferences,
rights, qualifications, limitations and restrictions, including, but not limited to, some or all of the following:
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the number of shares constituting that series
and the distinctive designation of that series, which number may be increased or decreased (but not below the number of shares
then outstanding) from time to time by action of the board of directors;
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the dividend rate and the manner and frequency
of payment of dividends on the shares of that series, whether dividends will be cumulative, and, if so, from which date;
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whether that series will have voting rights,
in addition to any voting rights provided by law, and, if so, the terms of such voting rights;
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whether that series will have conversion privileges,
and, if so, the terms and conditions of such conversion, including provision for adjustment of the conversion rate in such
events as the board of directors may determine;
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whether or not the shares of that series will
be redeemable, and, if so, the terms and conditions of such redemption;
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whether that series will have a sinking fund
for the redemption or purchase of shares of that series, and, if so, the terms and amount of such sinking fund;
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whether or not the shares of the series will
have priority over or be on a parity with or be junior to the shares of any other series or class in any respect;
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the rights of the shares of that series in the
event of voluntary or involuntary liquidation, dissolution or winding up of the corporation, and the relative rights or priority,
if any, of payment of shares of that series; and
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any other relative rights, preferences and limitations
of that series.
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Once
designated by our board of directors, each series of preferred stock may have specific financial and other terms that will be
described in a prospectus supplement. The description of the preferred stock that is set forth in any prospectus supplement is
not complete without reference to the documents that govern the preferred stock. These include our certificate of incorporation
and any certificates of designation that our board of directors may adopt.
All
shares of preferred stock offered hereby will, when issued, be fully paid and non-assessable, including shares of preferred stock
issued upon the exercise of preferred stock warrants or subscription rights, if any.
Although
our board of directors has no intention at the present time of doing so, it could authorize the issuance of a series of preferred
stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt.
Warrants
Common
Stock Warrants
On December 27, 2013 and January 10, 2014, we issued common stock warrants to certain investors in a private
placement of common stock and warrants (the “Common Stock Warrants”). The Common Stock Warrants have a five
year term from each closing that occurred on December 27, 2013 and January 10, 2014, and are exercisable for an aggregate of up
to 276,529 shares of our common stock at an initial per share exercise price of $9.00, subject to adjustments as set forth below.
As of October 11, 2017 we have 193,197 shares of Common Stock Warrants outstanding. We may also call this warrant for redemption
upon written notice to all warrant holders at any time the closing price of the common stock exceeds $15.00 (as may be adjusted
pursuant to warrant agreement) for 20 consecutive trading days, as reported by Bloomberg, provided at such time there is an effective
registration statement covering the resale of the shares underlying the warrants. In the 60 business days following
the date the redemption notice is deemed given in accordance with the agreement, investors may choose to exercise this warrant
or a portion of the warrant by paying the then applicable exercise price per share for every share exercised. Any shares
not exercised on the last day of the exercise period will be redeemed by us at $0.001 per share.
The exercise prices of the Common Stock
Warrants are subject to adjustment upon certain events. If we at any time while the warrants remain outstanding and unexpired
shall declare a dividend or make a distribution on the outstanding Common Stock payable in shares of its capital stock, or split,
subdivide or combine the securities as to which purchase rights under this warrant exist into a different number of securities
of the same class, the exercise price for such securities shall be proportionately decreased in the case of a dividend, split
or subdivision or proportionately increased in the case of a combination.
Series
B Warrants
The Series B Warrants have a five year term
from December 19, 2012 and are exercisable for an aggregate of up to 1,559,505 shares of our common stock at an initial per share
exercise price of $2.48, subject to adjustment as set forth below. As of October 11, 2017, there were 1,317,195 warrants
outstanding. These warrants have a cashless exercise provision. We also have a right of first refusal on the holder’s
sale of the warrant shares. We may also call this warrant for redemption upon written notice to all warrant holders
at any time the closing price of the common stock exceeds $1.50 (as may be adjusted pursuant to warrant agreement) for 20 consecutive
trading days, as reported by Bloomberg, provided at such time there is an effective registration statement covering the resale
of the shares underlying the warrants. In the 60 business days following the date the redemption notice is deemed given
in accordance with the agreement, investors may choose to exercise this warrant or a portion of the warrant by paying the then
applicable exercise price per share for every share exercised. Any shares not exercised on the last day of the exercise
period will be redeemed by us at $0.001 per share.
The exercise price of the Series B Warrants
is subject to adjustment upon certain events. If we at any time while the warrants remain outstanding and unexpired shall declare
a dividend or make a distribution on the outstanding Common Stock payable in shares of its capital stock, or split, subdivide
or combine the securities as to which purchase rights under this warrant exist into a different number of securities of the same
class, the exercise price for such securities shall be proportionately decreased in the case of a dividend, split or subdivision
or proportionately increased in the case of a combination.
In addition, for so long as there are any
warrants outstanding, if and whenever at any time and from time to time after the warrant issue date, as applicable, we shall
issue any shares of common stock for no consideration or a consideration per share less than the exercise price, as applicable,
then, forthwith upon such issue or sale, the warrants shall be subject to a proportional adjustment determined by multiplying
such warrant exercise price by the following fraction:
Where:
N(0)
= the number of shares of common stock outstanding (calculated on a Fully Diluted Basis) immediately prior to the issuance of
such additional shares of common stock or common stock Equivalents;
N(1) = the number of shares of common stock
which the aggregate consideration, if any (including the aggregate Net Consideration Per Share with respect to the issuance of
common stock equivalents), received or receivable by us for the total number of such additional shares of common stock so issued
or deemed to be issued would purchase at the warrant exercise price, as applicable, in effect immediately prior to such issuance;
and
N(2)
= the number of such additional shares of common stock so issued or deemed to be issued.
Stock
Offering Warrants
The Stock Offering Warrants have a term ending on January 31, 2019 and are exercisable for an aggregate
of up to 2,682,155 shares of our common stock at an initial per share exercise price of $0.78, subject to adjustment as set forth
below (anti-dilution). As of October 11, 2017, there were 1,239,997 warrants outstanding. These warrants have a cashless
exercise provision. We also have a right of first refusal on the holder’s sale of the warrant shares.
These warrants have a cashless exercise provision. We also have a right of first refusal on
the holder’s sale of the warrant shares. The exercise prices of the Stock Offering Warrants are subject
to adjustment upon certain events. If we at any time while the warrants remain outstanding and unexpired shall declare a dividend
or make a distribution on the outstanding Common Stock payable in shares of its capital stock, or split, subdivide or combine the
securities as to which purchase rights under this warrant exist into a different number of securities of the same class, the exercise
price for such securities shall be proportionately decreased in the case of a dividend, split or subdivision or proportionately
increased in the case of a combination.
Consulting
Firm Warrants
The Consulting Firm Warrants have a term ending on December 17, 2019 and are exercisable for an aggregate
of up to 3,755,560 shares of the Company’s common stock. As of October 11, 2017, there were 1,502,223 warrants
outstanding. These warrants may not be exercised by the Holder upon less than 90 days prior written notice of such exercise and
provided further that that the Holder may elect, in its sole discretion, to waive the Prior Notice Requirement, in whole or in
part, upon 65 days prior written notice of such waiver. These warrants have a cashless exercise provision
and were issued at an initial per share exercise price of $0.001, subject to adjustment as if the Company at any time while the
warrants remain outstanding and unexpired shall declare a dividend or make a distribution on the outstanding Common Stock payable
in shares of its capital stock, or split, subdivide or combine the securities as to which purchase rights under this warrant exist
into a different number of securities of the same class, the exercise price for such securities shall be proportionately decreased
in the case of a dividend, split or subdivision or proportionately increased in the case of a combination. The warrants
are also subject to piggy-back registration rights.
2015
Offering Warrants
The 2015 Offering Warrants have a term ending
February 11, 2019 and are exercisable for an aggregate of up to 3,333,333 shares of our common stock at $6.50 per share. As of
October 11, 2017, there were 3,333,333 warrants outstanding. The exercise price and the number of warrant shares shall be adjusted
from time to time if we at any time on or after the issuance date subdivides (by any stock split, stock dividend, recapitalization
or otherwise) one or more classes of its outstanding shares of common stock into a greater number of shares, the exercise price
in effect immediately prior to such subdivision will be proportionately reduced and the number of warrant shares will be proportionately
increased. If we at any time on or after the issuance date combines (by combination, reverse stock split or otherwise)
one or more classes of its outstanding shares of Common Stock into a smaller number of shares, the exercise price in effect immediately
prior to such combination will be proportionately increased and the number of warrant shares will be proportionately decreased.
If at any time prior to
the expiration date we grant, issue or sell any Options, Convertible Securities or rights to purchase stock, warrants, securities
or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then
the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which
the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of
this warrant (without regard to any limitations on the exercise of this warrant) immediately before the date on which a record
is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record
holders of shares of common stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however,
that to the extent that the Holder’s right to participate in any such Purchase Right would result in the holder exceeding
the Maximum Percentage, then the holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial
ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right to such extent
shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding
the Maximum Percentage (as defined in the warrant), at which time the Holder shall be granted such right to the same extent as
if there had been no such limitation).
Placement
Agent Warrants
We
have issued three types of warrants to the Placement Agent, Placement Agent Stock Offering Warrants, Placement Agent Common Stock
Warrants, and Placement Agent December 2013 Offering Warrants.
Placement
Agent Stock Offering Warrants
The Placement Agent Stock Offering Warrants
have a term ending on January 31, 2019 and are exercisable for an aggregate of up to 1,251,022 shares of our common stock at an
initial per share exercise price of $0.78, subject to adjustment as set forth below (anti dilution). As of October 11, 2017,
there were 355,293 warrants outstanding. These warrants have a cashless exercise provision. The exercise prices
of the warrants are subject to adjustment upon certain events. If we at any time while the warrants remain outstanding and unexpired
shall declare a dividend or make a distribution on the outstanding Common Stock payable in shares of its capital stock, or split,
subdivide or combine the securities as to which purchase rights under this warrant exist into a different number of securities
of the same class, the exercise price for such securities shall be proportionately decreased in the case of a dividend, split
or subdivision or proportionately increased in the case of a combination.
Placement
Agent Common Stock Warrants
The Placement Agent Common Stock Warrants
have a five year term from January 28, 2013 and are exercisable for an aggregate of up to 467,845 shares of our common stock at
an initial per share exercise price of $2.48, subject to adjustment as set forth below. As of October 11, 2017, there
were 298,065 warrants outstanding. These warrants have a cashless exercise provision. We may also call this warrant for redemption
upon written notice to all warrant holders at any time the closing price of the common stock exceeds $1.50 (as may be adjusted
pursuant to warrant agreement) for 20 consecutive trading days, as reported by Bloomberg, provided at such time there is an effective
registration statement covering the resale of the shares underlying the warrants. In the 60 business days following
the date the redemption notice is deemed given in accordance with the agreement, investors may choose to exercise this warrant
or a portion of the warrant by paying the then applicable exercise price per share for every share exercised. Any shares
not exercised on the last day of the exercise period will be redeemed by us at $0.001 per share.
The exercise prices of the warrants are
subject to adjustment upon certain events. If we at any time while the warrants remain outstanding and unexpired shall declare
a dividend or make a distribution on the outstanding Common Stock payable in shares of its capital stock, or split, subdivide
or combine the securities as to which purchase rights under this warrant exist into a different number of securities of the same
class, the exercise price for such securities shall be proportionately decreased in the case of a dividend, split or subdivision
or proportionately increased in the case of a combination.
In addition, for so long as there are any warrants outstanding, if and whenever at any time and from time
to time after the warrant issue date, as applicable, we shall issue any shares of common stock for no consideration or a consideration
per share less than the exercise price, as applicable, then, forthwith upon such issue or sale, the warrants shall be subject to
a proportional adjustment determined by multiplying such warrant exercise price by the following fraction:
Where:
N(0)
= the number of shares of common stock outstanding (calculated on a Fully Diluted Basis) immediately prior to the issuance of
such additional shares of common stock or common stock Equivalents;
N(1)
= the number of shares of common stock which the aggregate consideration, if any (including the aggregate Net Consideration Per
Share with respect to the issuance of common stock equivalents), received or receivable by the Company for the total number of
such additional shares of common stock so issued or deemed to be issued would purchase at the warrant exercise price, as applicable,
in effect immediately prior to such issuance; and
N(2)
= the number of such additional shares of common stock so issued or deemed to be issued.
Placement
Agent December 2013 Offering Warrants
The Placement Agent December 2013 Offering Warrants have a five year term from January 10, 2014 and are
exercisable for an aggregate of up to 138,265 shares of our common stock at an initial per share exercise price of $9.00, subject
to adjustment as set forth below. As of October 11, 2017, there were 124,997 warrants outstanding. These warrants have
a cashless exercise provision. We may also call this warrant for redemption upon written notice to all warrant holders
at any time the closing price of the common stock exceeds $15.00 (as may be adjusted pursuant to warrant agreement) for 20 consecutive
trading days, as reported by Bloomberg, provided at such time there is an effective registration statement covering the resale
of the shares underlying the warrants. In the 60 business days following the date the redemption notice is deemed given
in accordance with the agreement, investors may choose to exercise this warrant or a portion of the warrant by paying the then
applicable exercise price per share for every share exercised. Any shares not exercised on the last day of the exercise
period will be redeemed by us at $0.001 per share.
The exercise prices of the warrants are
subject to adjustment upon certain events. If we at any time while the warrants remain outstanding and unexpired shall declare
a dividend or make a distribution on the outstanding Common Stock payable in shares of its capital stock, or split, subdivide
or combine the securities as to which purchase rights under this warrant exist into a different number of securities of the same
class, the exercise price for such securities shall be proportionately decreased in the case of a dividend, split or subdivision
or proportionately increased in the case of a combination.
Consultant
Warrants.
As of October 11, 2017, we had outstanding
warrants exercisable for 507,833 shares of common stock issued to various consultants in consideration for services. The exercise
prices range from $0.98 to $11.66 per share. These warrants do not have a cashless exercise provision.
2017
Warrants
In July 2017 in connection with an offering, we issued warrants to purchase 18,275,000 shares of Common
Stock (the “Warrants”). The Warrants are exercisable commencing on the issuance date at an exercise price equal to
$1.05 per whole share of common stock, subject to adjustments as provided under the terms of the Warrants. The Warrants are exercisable
for five years from the date of issuance. These warrants do have a cashless exercise provision.
Registration
Rights
On December 21, 2015,
we entered into an Investor Rights Agreement (the “Investor Rights Agreement”) with Memorial Sloan Cancer Center (“MSKCC”).
Under the terms of the Investor Rights Agreement, Actinium has granted MSKCC piggyback registration rights that would be triggered
in the event Actinium were to engage in a public registered offering of its shares for its own account where other shareholders
are participating as selling shareholders or where such public registered offering is for the account of other selling shareholders.
In addition, Actinium has granted MSKCC unlimited Form S-3 registration rights with respect to its shares.
Delaware
Anti-Takeover Law, Provisions of our Certificate of Incorporation and Bylaws
Delaware
Anti-Takeover Law
We
are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years
after the date of the transaction in which the person became an interested stockholder, unless:
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prior to the date of the transaction, the board
of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder
becoming an interested stockholder;
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the interested stockholder owned at least 85%
of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining
the number of shares outstanding (i) shares owned by persons who are directors and also officers and (ii) shares owned by
employee stock plans in which employee participants do not have the right to determine confidentially whether shares held
subject to the plan will be tendered in a tender or exchange offer; or
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on or subsequent to the date of the transaction,
the business combination is approved by the board and authorized at an annual or special meeting of stockholders, and not
by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the
interested stockholder.
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Section
203 defines a business combination to include:
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any merger or consolidation involving the corporation
and the interested stockholder;
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any sale, transfer, pledge or other disposition
involving the interested stockholder of 10% or more of the assets of the corporation;
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subject to exceptions, any transaction that
results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder; or
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the receipt by the interested stockholder of
the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.
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In
general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding
voting stock of the corporation and any entity or person affiliated with, or controlling, or controlled by, the entity or person.
The term “owner” is broadly defined to include any person that, individually, with or through that person’s
affiliates or associates, among other things, beneficially owns the stock, or has the right to acquire the stock, whether or not
the right is immediately exercisable, under any agreement or understanding or upon the exercise of warrants or options or otherwise
or has the right to vote the stock under any agreement or understanding, or has an agreement or understanding with the beneficial
owner of the stock for the purpose of acquiring, holding, voting or disposing of the stock.
The
restrictions in Section 203 do not apply to corporations that have elected, in the manner provided in Section 203, not to be subject
to Section 203 of the Delaware General Corporation Law or, with certain exceptions, which do not have a class of voting stock
that is listed on a national securities exchange or authorized for quotation on the Nasdaq Stock Market or held of record by more
than 2,000 stockholders. Our certificate of incorporation and bylaws do not opt out of Section 203.
Section
203 could delay or prohibit mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage
attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price
above the prevailing market price.
Certificate
of Incorporation and Bylaws
Provisions
of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in
our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their
shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions
could adversely affect the price of our common stock. Among other things, our certificate of incorporation and bylaws:
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permit our board of directors to issue up to
50,000,000 shares of preferred stock, without further action by the stockholders, with any rights, preferences and privileges
as they may designate, including the right to approve an acquisition or other change in control;
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provide that all vacancies, including newly
created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors
then in office;
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divide our board of directors into three classes,
with each class serving staggered three-year terms, with such three year term commencing on the election of a director on
and after the 2014 annual meeting;
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do not provide for cumulative voting rights
(therefore allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors
to elect all of the directors standing for election, if they should so choose);
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provide that special meetings of our stockholders
may be called only by our Chairman of the Board, board of directors, chief executive officer ,or the holders of not less than
one-tenth of all the shares entitled to vote at the meeting; and
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set forth an advance notice procedure with regard
to business to be brought before a meeting of stockholders.
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DESCRIPTION
OF DEBT SECURITIES
We
may issue debt securities from time to time, in one or more series, as either senior or subordinated debt or as senior or subordinated
convertible debt. While the terms we have summarized below will apply generally to any debt securities that we may offer
under this prospectus, we will describe the particular terms of any debt securities that we may offer in more detail in the applicable
prospectus supplement. The terms of any debt securities offered under a prospectus supplement may differ from the terms
described below. Unless the context requires otherwise, whenever we refer to the indenture, we are also referring to any
supplemental indentures that specify the terms of a particular series of debt securities.
We will issue the debt securities under
the indenture that we will enter into with the trustee named in the indenture. The indenture will be qualified under the
Trust Indenture Act of 1939, as amended ("Trust Indenture Act"). We have filed the form of indenture as an exhibit
to the registration statement of which this prospectus is a part, and supplemental indentures and forms of debt securities containing
the terms of the debt securities being offered will be filed as exhibits to the registration statement of which this prospectus
is a part or will be incorporated by reference from reports that we file with the SEC.
The
following summary of material provisions of the debt securities and the indenture is subject to, and qualified in its entirety
by reference to, all of the provisions of the indenture applicable to a particular series of debt securities. We urge you
to read the applicable prospectus supplements and any related free writing prospectuses related to the debt securities that we
may offer under this prospectus, as well as the complete indenture that contains the terms of the debt securities.
General
Terms of the Indenture
The
indenture does not limit the amount of debt securities that we may issue. It provides that we may issue debt securities
up to the principal amount that we may authorize and may be in any currency or currency unit designated by us. Except for
the limitations on consolidation, merger and sale of all or substantially all of our assets contained in the indenture, the terms
of the indenture do not contain any covenants or other provisions designed to afford holders of any debt securities protection
with respect to our operations, financial condition or transactions involving us.
We
may issue the debt securities issued under the indenture as "discount securities," which means they may be sold at a
discount below their stated principal amount. These debt securities, as well as other debt securities that are not issued
at a discount, may, for U.S. federal income tax purposes, be treated as if they were issued with "original issue discount,"
or "OID," because of interest payment and other characteristics. Special U.S. federal income tax considerations
applicable to debt securities issued with original issue discount will be described in more detail in any applicable prospectus
supplement.
We
will describe in the applicable prospectus supplement the terms of the series of debt securities being offered, including:
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the title of the series of debt securities;
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any limit upon the aggregate principal amount
that may be issued;
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the maturity date or dates;
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the form of the debt securities of the series;
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the applicability of any guarantees;
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whether or not the debt securities will be secured
or unsecured, and the terms of any secured debt;
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whether the debt securities rank as senior debt,
senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination;
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if the price (expressed as a percentage of the
aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount
thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or
if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the
method by which any such portion shall be determined;
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the interest rate or rates, which may be fixed
or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be
payable and the regular record dates for interest payment dates or the method for determining such dates;
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our right, if any, to defer payment of interest
and the maximum length of any such deferral period;
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if applicable, the date or dates after which,
or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt
securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions;
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the date or dates, if any, on which, and the
price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise,
to redeem, or at the holder's option to purchase, the series of debt securities and the currency or currency unit in which
the debt securities are payable;
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the denominations in which we will issue the
series of debt securities, if other than denominations of $1,000, and any integral multiple thereof;
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any and all terms, if applicable, relating to
any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such
debt securities and any other terms which may be advisable in connection with the marketing of debt securities of that series;
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whether the debt securities of the series shall
be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which
such global security or securities may be exchanged in whole or in part for other individual securities; and the depositary
for such global security or securities;
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if applicable, the provisions relating to conversion
or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible
or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted,
any mandatory or optional (at our option or the holders' option) conversion or exchange features, the applicable conversion
or exchange period and the manner of settlement for any conversion or exchange;
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if other than the full principal amount thereof,
the portion of the principal amount of debt securities of the series which shall be payable upon declaration of acceleration
of the maturity thereof;
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additions to or changes in the covenants applicable
to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant;
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additions to or changes in the events of default
with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium,
if any, and interest, if any, with respect to such securities to be due and payable;
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additions to or changes in or deletions of the
provisions relating to covenant defeasance and legal defeasance;
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additions to or changes in the provisions relating
to satisfaction and discharge of the indenture;
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additions to or changes in the provisions relating
to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture;
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the currency of payment of debt securities if
other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars;
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whether interest will be payable in cash or
additional debt securities at our or the holders' option and the terms and conditions upon which the election may be made;
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the terms and conditions, if any, upon which
we will pay amounts in addition to the stated interest, premium, if any, and principal amounts of the debt securities of the
series to any holder that is not a "United States person" for federal tax purposes;
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any restrictions on transfer, sale or assignment
of the debt securities of the series; and
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any other specific terms, preferences, rights
or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture,
and any terms that may be required by us or advisable under applicable laws or regulations.
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Conversion
or Exchange Rights
We
will set forth in the prospectus supplement the terms on which a series of debt securities may be convertible into or exchangeable
for our common stock or our other securities. We will include provisions as to settlement upon conversion or exchange and
whether conversion or exchange is mandatory, at the option of the holder or at our option. We may include provisions pursuant
to which the number of shares of our common stock or our other securities that the holders of the series of debt securities receive
would be subject to adjustment.
Consolidation,
Merger or Sale
Unless
we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the indenture will not
contain any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of our
assets as an entirety or substantially as an entirety. However, any successor to or acquirer of such assets (other than
a subsidiary of ours) must assume all of our obligations under the indenture or the debt securities, as appropriate.
Events
of Default Under the Indenture
Unless
we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the following are events
of default under the indenture with respect to any series of debt securities that we may issue:
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if we fail to pay any installment of interest
on any debt securities of that series, as and when the same shall become due and payable, and such default continues for a
period of 90 days; provided, however, that a valid extension of an interest payment period by us in accordance with the terms
of any indenture supplemental thereto shall not constitute a default in the payment of interest for this purpose;
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if we fail to pay the principal of (or premium,
if any) on any debt securities of that series as and when the same shall become due and payable whether at maturity, upon
redemption, by declaration or otherwise, or in any payment required by any sinking or analogous fund established with respect
to that series; provided, however, that a valid extension of the maturity of such debt securities in accordance with the terms
of any indenture supplemental thereto shall not constitute a default in the payment of principal or premium, if any;
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if we fail to observe or perform any other covenant
or agreement with respect to that series contained in the indenture or otherwise established with respect to that series pursuant
to the indenture, other than a covenant or agreement specifically included solely for the benefit of one or more debt securities
other than that series, and our failure continues for 90 days after we receive written notice of such failure, requiring the
same to be remedied and stating that such is a notice of default thereunder, from the trustee or holders of at least 25% in
aggregate principal amount of the outstanding debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency
or reorganization occur.
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If
an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default described
in the last bullet point above, the trustee or the holders of at least 25% in aggregate principal amount of the outstanding debt
securities of that series, by notice to us in writing, and to the trustee if notice is given by such holders, may declare the
unpaid principal of (premium, if any) and accrued and unpaid interest, if any, due and payable immediately. If an event
of default specified in the last bullet point above occurs with respect to us, the principal amount of and accrued interest, if
any, of that series shall be automatically due and payable without any declaration or other action on the part of the trustee
or any holder.
The
holders of a majority in principal amount of the outstanding debt securities of an affected series may waive any default or event
of default with respect to the series and its consequences, except defaults or events of default regarding payment of principal,
premium, if any, or interest, unless we have cured the default or event of default in accordance with the indenture. Any
waiver shall cure the default or event of default.
Subject
to the terms of the indenture, if an event of default under an indenture shall occur and be continuing, the trustee will be under
no obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of
the applicable series of debt securities, unless such holders have offered the trustee reasonable indemnity. The holders
of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method
and place of conducting any proceeding for any remedy available to the trustee, or exercising any trust or power conferred on
the trustee, with respect to the debt securities of that series, provided that:
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the direction so given by the holder is not
in conflict with any law or the applicable indenture; and
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subject to its duties under the Trust Indenture
Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the
holders not involved in the proceeding.
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A
holder of the debt securities of any series will have the right to institute a proceeding under the indenture or to appoint a
receiver or trustee, or to seek other remedies only if:
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the holder has given written notice to the trustee
of a continuing event of default with respect to that series;
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the holders of at least 25% in aggregate principal
amount of the outstanding debt securities of that series have made written request;
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such holders have offered to the trustee indemnity
satisfactory to it against the costs, expenses and liabilities to be incurred by the trustee in compliance with the request;
and
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the trustee does not institute the proceeding,
and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that
series other inconsistent directions within 90 days after the notice, request and offer.
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These
limitations do not apply to a suit instituted by a holder of debt securities if we default in the payment of the principal, premium,
if any, or interest on, the debt securities.
We
will periodically file statements with the trustee regarding our compliance with specified covenants in the indenture.
Modification
of Indenture; Waiver
We
and the trustee may change an indenture without the consent of any holders with respect to specific matters:
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to cure any ambiguity, defect or inconsistency
in the indenture or in the debt securities of any series;
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to comply with the provisions described above
under "Description of Debt Securities—Consolidation, Merger or Sale;"
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to provide for uncertificated debt securities
in addition to or in place of certificated debt securities;
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to add to our covenants, restrictions, conditions
or provisions such new covenants, restrictions, conditions or provisions for the benefit of the holders of all or any series
of debt securities, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants,
restrictions, conditions or provisions an event of default or to surrender any right or power conferred upon us in the indenture;
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to add to, delete from or revise the conditions,
limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication and delivery of debt securities,
as set forth in the indenture;
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to make any change that does not adversely affect
the interests of any holder of debt securities of any series in any material respect;
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to provide for the issuance of and establish
the form and terms and conditions of the debt securities of any series as provided above under "Description of Debt Securities—General"
to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series
of debt securities, or to add to the rights of the holders of any series of debt securities;
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to evidence and provide for the acceptance of
appointment under any indenture by a successor trustee; or
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to comply with any requirements of the SEC in
connection with the qualification of any indenture under the Trust Indenture Act.
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In
addition, under the indenture, the rights of holders of a series of debt securities may be changed by us and the trustee with
the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of
each series that is affected. However, unless we provide otherwise in the prospectus supplement applicable to a particular
series of debt securities, we and the trustee may make the following changes only with the consent of each holder of any outstanding
debt securities affected:
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extending the fixed maturity of any debt securities
of any series;
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reducing the principal amount, reducing the
rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any series of
any debt securities; or
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reducing the percentage of debt securities,
the holders of which are required to consent to any amendment, supplement, modification or waiver.
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Discharge
Each
indenture provides that we can elect to be discharged from our obligations with respect to one or more series of debt securities,
except for specified obligations, including obligations to:
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provide for payment;
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register the transfer or exchange of debt securities
of the series;
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replace stolen, lost or mutilated debt securities
of the series;
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pay principal of and premium and interest on
any debt securities of the series;
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maintain paying agencies;
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hold monies for payment in trust;
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recover excess money held by the trustee;
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compensate and indemnify the trustee; and
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appoint any successor trustee.
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In
order to exercise our rights to be discharged, we must deposit with the trustee money or government obligations sufficient to
pay all the principal of, any premium, if any, and interest on, the debt securities of the series on the dates payments are due.
Form,
Exchange and Transfer
We
will issue the debt securities of each series only in fully registered form without coupons and, unless we provide otherwise in
the applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indenture provides
that we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be
deposited with, or on behalf of, The Depository Trust Company, or DTC, or another depositary named by us and identified in a prospectus
supplement with respect to that series. To the extent the debt securities of a series are issued in global form and as book-entry,
a description of terms relating will be set forth in the applicable prospectus supplement.
At
the option of the holder, subject to the terms of the indenture and the limitations applicable to global securities described
in the applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for
other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject
to the terms of the indenture and the limitations applicable to global securities set forth in the applicable prospectus supplement,
holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly endorsed or
with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the
security registrar or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in
the debt securities that the holder presents for transfer or exchange, we will impose no service charge for any registration of
transfer or exchange, but we may require payment of any taxes or other governmental charges.
We
will name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar,
that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind
the designation of any transfer agent or approve a change in the office through which any transfer agent acts, except that we
will be required to maintain a transfer agent in each place of payment for the debt securities of each series.
If
we elect to redeem the debt securities of any series, we will not be required to:
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issue, register the transfer of, or exchange
any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing
of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on
the day of the mailing; or
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register the transfer of or exchange any debt
securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming
in part.
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Information
Concerning the Trustee
The
trustee, other than during the occurrence and continuance of an event of default under an indenture, undertakes to perform only
those duties as are specifically set forth in the applicable indenture. Upon an event of default under an indenture, the
trustee must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs.
Subject to this provision, the trustee is under no obligation to exercise any of the powers given it by the indenture at the request
of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities
that it might incur.
Payment
and Paying Agents
Unless
we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any debt securities on
any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered
at the close of business on the regular record date for the interest.
We
will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents
designated by us, except that unless we otherwise indicate in the applicable prospectus supplement, we will make interest payments
by check that we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the applicable
prospectus supplement, we will designate the corporate trust office of the trustee as our sole paying agent for payments with
respect to debt securities of each series. We will name in the applicable prospectus supplement any other paying agents
that we initially designate for the debt securities of a particular series. We will maintain a paying agent in each place
of payment for the debt securities of a particular series.
All
money we pay to a paying agent or the trustee for the payment of the principal of or any premium or interest on any debt securities
that remains unclaimed at the end of two years after such principal, premium or interest has become due and payable (or such shorter
period set forth in applicable escheat, abandoned or unclaimed property law) will be repaid to us, and the holder of the debt
security thereafter may look only to us for payment thereof.
Governing
Law
The
indenture and the debt securities will be governed by and construed in accordance with the laws of the State of New York, except
to the extent that the Trust Indenture Act is applicable.
DESCRIPTION
OF WARRANTS
As
of October 11, 2017, there were 27,147,183 shares of common stock that may be issued upon exercise of outstanding warrants.
We
may issue warrants for the purchase of debt securities, common stock or preferred stock in one or more series. We may issue warrants
independently or together with debt securities, common stock or preferred stock, and the warrants may be attached to or separate
from these securities.
We
will evidence each series of warrants by warrant certificates that we may issue under a separate agreement. We may enter into
a warrant agreement with a warrant agent. Each warrant agent may be a bank that we select which has its principal office in the
United States. We may also choose to act as our own warrant agent. We will indicate the name and address of any such warrant agent
in the applicable prospectus supplement relating to a particular series of warrants.
We
will describe in the applicable prospectus supplement the terms of the series of warrants, including:
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the offering price and aggregate number of warrants
offered;
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if applicable, the designation and terms of
the securities with which the warrants are issued and the number of warrants issued with each such security or each principal
amount of such security;
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if applicable, the date on and after which the
warrants and the related securities will be separately transferable;
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in the case of warrants to debt securities,
purchase common stock or preferred stock, the number or amount of shares of common stock or preferred stock, as the case may
be, purchasable upon the exercise of one warrant and the price at which and currency in which these shares may be purchased
upon such exercise;
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the manner of exercise of the warrants, including
any cashless exercise rights;
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the warrant agreement under which the warrants
will be issued;
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the effect of any merger, consolidation, sale
or other disposition of our business on the warrant agreement and the warrants;
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anti-dilution provisions of the warrants, if
any;
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the terms of any rights to redeem or call the
warrants;
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any provisions for changes to or adjustments
in the exercise price or number of securities issuable upon exercise of the warrants;
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the dates on which the right to exercise the
warrants will commence and expire or, if the warrants are not continuously exercisable during that period, the specific date
or dates on which the warrants will be exercisable;
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the manner in which the warrant agreement and
warrants may be modified;
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the identities of the warrant agent and any
calculation or other agent for the warrants;
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federal income tax consequences of holding or
exercising the warrants;
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the terms of the securities issuable upon exercise
of the warrants;
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any securities exchange or quotation system
on which the warrants or any securities deliverable upon exercise of the warrants may be listed or quoted; and
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any other specific terms, preferences, rights
or limitations of or restrictions on the warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including, in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any,
or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement,
holders of the warrants may exercise the warrants at any time up to 5:00 P.M. eastern time, the close of business, on the expiration
date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together
with specified information, and paying the required exercise price by the methods provided in the applicable prospectus supplement.
We will set forth on the reverse side of the warrant certificate, and in the applicable prospectus supplement, the information
that the holder of the warrant will be required to deliver to the warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities
purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we
will issue a new warrant certificate for the remaining amount of warrants.
Enforceability
of Rights By Holders of Warrants
Any
warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship
of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue
of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement
or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us.
Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate
legal action the holder’s right to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance
with their terms.
Warrant
Agreement Will Not Be Qualified Under Trust Indenture Act
No
warrant agreement will be qualified as an indenture, and no warrant agent will be required to qualify as a trustee, under the
Trust Indenture Act. Therefore, holders of warrants issued under a warrant agreement will not have the protection of the Trust
Indenture Act with respect to their warrants.
Governing
Law
Each
warrant agreement and any warrants issued under the warrant agreements will be governed by New York law.
DESCRIPTION
OF RIGHTS
We
may issue rights to our stockholders to purchase shares of our common stock or preferred stock. We may offer rights separately
or together with one or more additional rights, debt securities, preferred stock, common stock or warrants, or any combination
of those securities in the form of units, as described in the applicable prospectus supplement. Each series of rights will be
issued under a separate rights agreement to be entered into between us and a bank or trust company, as rights agent. The rights
agent will act solely as our agent in connection with the certificates relating to the rights of the series of certificates and
will not assume any obligation or relationship of agency or trust for or with any holders of rights certificates or beneficial
owners of rights. The following description sets forth certain general terms and provisions of the rights to which any prospectus
supplement may relate. The particular terms of the rights to which any prospectus supplement may relate and the extent, if any,
to which the general provisions may apply to the rights so offered will be described in the applicable prospectus supplement.
To the extent that any particular terms of the rights, rights agreement or rights certificates described in a prospectus supplement
differ from any of the terms described below, then the terms described below will be deemed to have been superseded by that prospectus
supplement. We encourage you to read the applicable rights agreement and rights certificate for additional information before
you decide whether to purchase any of our rights.
We
will provide in a prospectus supplement the following terms of the rights being issued:
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the date on which stockholders entitled to the
rights distribution will be determined;
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the aggregate number of shares of common stock
or preferred stock purchasable upon exercise of the rights;
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the exercise price;
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the aggregate number of rights issued;
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the date, if any, on and after which the rights
will be separately transferable;
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the date on which the ability to exercise the
rights will commence, and the date on which such ability will expire;
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the conditions to the completion of the offering,
if any;
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the withdrawal, termination and cancellation
rights, if any;
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any applicable material U.S. federal income
tax considerations; and
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any other terms of the rights, including terms,
procedures and limitations relating to the distribution, exchange and exercise of the rights.
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Each
right will entitle the holder of rights to purchase, for cash, the number of shares of common stock or preferred stock at the
exercise price provided in the applicable prospectus supplement. Rights may be exercised at any time up to the close of business
on the expiration date for the rights provided in the applicable prospectus supplement.
Holders
may exercise rights as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly
completed and duly executed at the corporate trust office of the rights agent or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the shares of common stock or preferred stock, as applicable, purchasable
upon exercise of the rights. If less than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed
securities directly to persons other than stockholders, to or through agents, underwriters or dealers or through a combination
of such methods, including pursuant to standby arrangements, as described in the applicable prospectus supplement.
DESCRIPTION
OF PURCHASE CONTRACTS
We
may issue purchase contracts, including contracts obligating holders to purchase from us, and for us to sell to holders, a specific
or variable number of our debt securities, shares of common stock, preferred stock, warrants or rights, or securities of an entity
unaffiliated with us, or any combination of the above, at a future date or dates. Alternatively, the purchase contracts may obligate
us to purchase from holders, and obligate holders to sell to us, a specific or variable number of our debt securities, shares
of common stock, preferred stock, warrants, rights or other property, or any combination of the above. The price of the securities
or other property subject to the purchase contracts may be fixed at the time the purchase contracts are issued or may be determined
by reference to a specific formula described in the purchase contracts. We may issue purchase contracts separately or as a part
of units each consisting of a purchase contract and one or more of our other securities described in this prospectus or securities
of third parties, including U.S. Treasury securities, securing the holder’s obligations under the purchase contract.
The purchase contracts may require us to make periodic payments to holders or vice versa and the payments may be unsecured or
pre-funded on some basis. The purchase contracts may require holders to secure the holder’s obligations in a manner specified
in the applicable prospectus supplement.
The
applicable prospectus supplement will describe the terms of any purchase contracts in respect of which this prospectus is being
delivered, including, to the extent applicable, the following:
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whether the purchase contracts obligate the
holder or us to purchase or sell, or both purchase and sell, the securities subject to purchase under the purchase contract,
and the nature and amount of each of those securities, or the method of determining those amounts;
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whether the purchase contracts are to be prepaid;
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whether the purchase contracts are to be settled
by delivery, or by reference or linkage to the value, performance or level of the securities subject to purchase under the
purchase contract;
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any acceleration, cancellation, termination
or other provisions relating to the settlement of the purchase contracts;
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any applicable federal income tax considerations; and
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whether the purchase contracts will be issued
in fully registered or global form.
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The
preceding description sets forth certain general terms and provisions of the purchase contracts to which any prospectus supplement
may relate. The particular terms of the purchase contracts to which any prospectus supplement may relate and the extent, if any,
to which the general provisions may apply to the purchase contracts so offered will be described in the applicable prospectus
supplement. To the extent that any particular terms of the purchase contracts described in a prospectus supplement differ from
any of the terms described above, then the terms described above will be deemed to have been superseded by that prospectus supplement.
We encourage you to read the applicable purchase contract for additional information before you decide whether to purchase any
of our purchase contracts.
DESCRIPTION
OF UNITS
We
may issue units comprised of one or more of the other securities described in this prospectus or any prospectus supplement in
any combination. Each unit will be issued so that the holder of the unit is also the holder, with the rights and obligations of
a holder, of each security included in the unit. The unit agreement under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately, at any time or at any times before a specified date or upon the
occurrence of a specified event or occurrence.
The
applicable prospectus supplement will describe:
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the designation and the terms of the units and
of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred
separately;
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any unit agreement under which the units will
be issued;
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any provisions for the issuance, payment, settlement,
transfer or exchange of the units or of the securities comprising the units; and
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whether the units will be issued in fully registered
or global form.
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PLAN
OF DISTRIBUTION
We
may sell the securities being offered pursuant to this prospectus to or through underwriters, through dealers, through agents,
or directly to one or more purchasers or through a combination of these methods. The applicable prospectus supplement will describe
the terms of the offering of the securities, including:
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the name or names of any underwriters, if any,
and if required, any dealers or agents;
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the purchase price of the securities and the
proceeds we will receive from the sale;
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any underwriting discounts and other items constituting
underwriters’ compensation;
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any discounts or concessions allowed or re-allowed
or paid to dealers; and
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any securities exchange or market on which the
securities may be listed or traded.
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We
may distribute the securities from time to time in one or more transactions at:
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a fixed price or prices, which may be changed;
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market prices prevailing at the time of sale,
directly by us or through a designated agent;
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prices related to such prevailing market prices;
or
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negotiated prices.
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Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name
of each underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation
of the underwriters and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting
syndicates represented by managing underwriters or directly by one or more investment banking firms or others, as designated.
If an underwriting syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement.
If underwriters are used in the sale, the offered securities will be acquired by the underwriters for their own accounts and may
be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or
at varying prices determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed
or paid to dealers may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations
of the underwriters to purchase the offered securities will be subject to conditions precedent, and the underwriters will be obligated
to purchase all of the offered securities, if any are purchased.
We
may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering
price, with additional underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms
of any over-allotment option will be set forth in the prospectus supplement for those securities.
If
we use a dealer in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will
sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to
be determined by the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified
in a prospectus supplement.
We
may sell the securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, any agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by institutional investors to purchase securities from us at the public
offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery
on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation
of these contracts in the prospectus supplement.
In
connection with the sale of the securities, underwriters, dealers or agents may receive compensation from us or from purchasers
of the securities for whom they act as agents, in the form of discounts, concessions or commissions. Underwriters may sell the
securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions
from the underwriters or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that
participate in the distribution of the securities, and any institutional investors or others that purchase securities directly
for the purpose of resale or distribution, may be deemed to be underwriters, and any discounts or commissions received by them
from us and any profit on the resale of the common stock by them may be deemed to be underwriting discounts and commissions under
the Securities Act of 1933, as amended.
We
may provide agents, underwriters and other purchasers with indemnification against particular civil liabilities, including liabilities
under the Securities Act of 1933, as amended, or contribution with respect to payments that the agents, underwriters or other
purchasers may make with respect to such liabilities. Agents and underwriters may engage in transactions with, or perform services
for, us in the ordinary course of business.
To
facilitate the public offering of a series of securities, persons participating in the offering may engage in transactions that
stabilize, maintain, or otherwise affect the market price of the securities. This may include over-allotments or short sales of
the securities, which involves the sale by persons participating in the offering of more securities than have been sold to them
by us. In addition, those persons may stabilize or maintain the price of the securities by bidding for or purchasing securities
in the open market or by imposing penalty bids, whereby selling concessions allowed to underwriters or dealers participating in
any such offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The
effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might
otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. We make no representation
or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented, may have on
the price of our securities.
Unless
otherwise specified in the applicable prospectus supplement, any common stock sold pursuant to a prospectus supplement will
be eligible for listing on a national securities exchange, such as the NYSE American or NASDAQ, subject to official notice of
issuance. Any underwriters to whom securities are sold by us for public offering and sale may make a market in the
securities, but such underwriters will not be obligated to do so and may discontinue any market making at any time without
notice.
In
order to comply with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus will
be sold in those states only through registered or licensed brokers or dealers. In addition, in some states securities may not
be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or
qualification requirement is available and complied with.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon by The Matt Law Firm, PLLC Utica, New York.
EXPERTS
The
financial statements incorporated in this prospectus by reference to the Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 have been so incorporated in reliance on the report of GBH CPAs, PC, an independent registered public accounting
firm, given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and in accordance therewith
file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission.
Such reports, proxy statements and other information can be read and copied at the Securities and Exchange Commission’s
public reference facilities at 100 F Street, N.E., Washington, D.C. 20549, at prescribed rates. Please call the Securities
and Exchange Commission at 1-800-732-0330 for further information on the operation of the public reference facilities. In addition,
the Securities and Exchange Commission maintains a website that contains reports, proxy and information statements and other information
regarding registrants that file electronically with the Securities and Exchange Commission. The address of the Securities and
Exchange Commission’s website is www.sec.gov.
We
make available free of charge on or through our website at www.actiniumpharmaceuticals.com, our Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant
to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we
electronically file such material with or otherwise furnish it to the Securities and Exchange Commission.
We
have filed with the Securities and Exchange Commission a registration statement under the Securities Act of 1933, as amended,
relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional
relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration
statement. You can obtain a copy of the registration statement, at prescribed rates, from the Securities and Exchange Commission
at the address listed above, or for free at www.sec.gov. The registration statement and the documents referred to below under
“Incorporation of Certain Information By Reference” are also available on our website, www.actiniumpharmaceuticals.com.
We
have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
Securities and Exchange Commission allows us to “incorporate by reference” the information we have filed with it,
which means that we can disclose important information to you by referring you to those documents. The information we incorporate
by reference is an important part of this prospectus, and later information that we file with the Securities and Exchange Commission
will automatically update and supersede this information. We incorporate by reference the documents listed below and any future
documents (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the Securities and Exchange
Commission pursuant to Sections l3(a), l3(c), 14 or l5(d) of the Securities Exchange Act of 1934, as amended, subsequent to the
date of this prospectus and prior to the termination of the offering:
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Our Annual Report on Form 10-K for the fiscal
year ended December 31, 2016, filed with the Securities and Exchange Commission on March 16, 2017;
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Our Quarterly Report on Form 10-Q for the fiscal
quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 15, 2017;
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Our Quarterly Report on Form 10-Q for the fiscal
quarter ended June 30, 2017, filed with the Securities and Exchange Commission on August 4, 2017;
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Our Current Report
on Form 8-K, filed with the Securities and Exchange Commission on March 28, 2017;
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Our Current Report
on Form 8-K, filed with the Securities and Exchange Commission on May 11, 2017;
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Our Current Report
on Form 8-K, filed with the Securities and Exchange Commission on May 16, 2017;
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Our Current Report
on Form 8-K/A, filed with the Securities and Exchange Commission on May 26, 2017;
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Our Current Report
on Form 8-K, filed with the Securities and Exchange Commission on June 8, 2017;
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Our Current Report on Form 8-K, filed
with the Securities and Exchange Commission on June 9, 2017;
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Our Current Report
on Form 8-K, filed with the Securities and Exchange Commission on June 16, 2017;
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Our Current Report
on Form 8-K, filed with the Securities and Exchange Commission on July 3, 2017;
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Our Current Report on Form 8-K, filed with the
Securities and Exchange Commission on July 28, 2017;
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The description of our common stock, which is
contained in our Form 8-K/A, filed with the Securities and Exchange Commission on January 28, 2013.
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All
filings filed by us pursuant to the Securities Exchange Act of 1934, as amended, after the date of the initial filing of this
registration statement and prior to the effectiveness of such registration statement (excluding information furnished pursuant
to Items 2.02 and 7.01 of Form 8-K) shall also be deemed to be incorporated by reference into the prospectus.
You
should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone else
to provide you with different information. You should not assume that the information in this prospectus is accurate as of any
date other than the date of this prospectus or the date of the documents incorporated by reference in this prospectus.
We will provide without charge to each person
to whom a copy of this prospectus is delivered, upon written or oral request, a copy of any or all of the information that has
been incorporated by reference in this prospectus but not delivered with this prospectus (other than an exhibit to these filings,
unless we have specifically incorporated that exhibit by reference in this prospectus). Any such request should be addressed to
us at: 275 Madison Avenue, 7th Floor, New York, New York 10016, Attention: Steve O’Loughlin, Principal Financial Officer,
or made by phone at (646) 677-3875. You may also access the documents incorporated by reference in this prospectus through our
website at www.actiniumpharmceuticals.com. Except for the specific incorporated documents listed above, no information available
on or through our website shall be deemed to be incorporated in this prospectus or the registration statement of which it forms
a part.
Up to $32,500,000 of Common Stock and
4,229,091 Shares of Common Stock
_______________________________
Prospectus Supplement
_______________________________
October 18, 2018
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