Source: sec
Source ID: 0001213900-26-086769
URL: https://www.sec.gov/Archives/edgar/data/1388320/000121390026086769/ea0298254-10q_actinium.htm
Symbol: (ATNM)
Published: 2026-08-07 17:00:38 EDT
Time precision: minute
Title: 10-Q QUARTERLY REPORT

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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
June 30,
2026
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from __________ to __________
Commission File Number:
001-36374
ACTINIUM PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
74-2963609
(State or Other Jurisdiction
of
Incorporation or Organization)
(I.R.S. Employer*
Identification No.)
100 Park Ave., 23
rd
Floor
New York
,
NY
10017
(Address of Principal Executive
Offices)
(Zip Code)
(646)
677-3870
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol
Name
of exchange on which registered
Common stock, par value $0.001
ATNM
NYSE American
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Yes
No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Yes
No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards, provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes
☒
No
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of August 6, 2026:
31,441,436
Actinium
Pharmaceuticals, Inc.
Table
of Contents
INDEX
PART
I – FINANCIAL INFORMATION
Item 1.
Financial
Statements
1
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
18
Item 3.
Quantitative
and Qualitative Disclosures About Market Risk
52
Item 4.
Controls
and Procedures
52
PART
II – OTHER INFORMATION
53
Item 1.
Legal
Proceedings
53
Item 1A.
Risk Factors
53
Item 2.
Unregistered
Sales of Equity Securities and Use of Proceeds
89
Item 3.
Defaults
Upon Senior Securities
89
Item 4.
Mine Safety
Disclosures
89
Item 5.
Other
Information
89
Item 6.
Exhibits
90
SIGNATURES
91
i
PART
I - FINANCIAL INFORMATION
ITEM
1. UNAUDITED FINANCIAL STATEMENTS
The
accompanying condensed consolidated financial statements have been prepared by Actinium Pharmaceuticals, Inc., or the Company, and are
unaudited. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly
the financial position at June 30, 2026 and December 31, 2025, and the results of operations and cash flows for the three months and
six months ended June 30, 2026 and 2025, respectively, have been made. Certain information and footnote disclosures normally included
in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been
condensed or omitted. It is suggested that these financial statements be read in conjunction with the financial statements and notes
thereto included in the Company’s audited financial statements for the year ended December 31, 2025 in the Company’s Annual
Report on Form 10-K. The results of operations for the three months and six months ended June 30, 2026 are not necessarily indicative
of the operating results for the full year.
1
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
(amounts
in thousands, except share and per share data)
June
30,
2026
December 31,
2025
(Unaudited)
Assets
Current Assets:
Cash and cash equivalents
$
36,473
$
47,998
Prepaid expenses and other current assets
1,267
1,383
Total Current Assets
37,740
49,381
Property and equipment, net of accumulated depreciation of $
846
and $
1,064
700
295
Restricted cash – long-term
339
335
Operating leases right-of-use assets, net
1,373
1,754
Finance leases right-of-use assets, net
5
10
Total Assets
$
40,157
$
51,775
Liabilities
and Stockholders’ Equity
Current
Liabilities:
Accounts payable and accrued expenses
$
8,514
$
7,247
Operating leases current liability
741
711
Finance leases current liability
5
11
Total Current Liabilities
9,260
7,969
Long-term license revenue deferred
-
35,000
Long-term operating lease obligations
595
972
Total Liabilities
9,855
43,941
Commitments and contingencies
Stockholders’
Equity:
Preferred stock, $
0.001
par value;
50,000,000
shares authorized,
0
shares issued and outstanding
-
-
Common stock, $
0.001
par value;
1,000,000,000
shares authorized;
31,441,436
and
31,195,891
shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
31
31
Additional paid-in capital
417,665
417,536
Accumulated other comprehensive loss
(
60
)
(
20
)
Accumulated deficit
(
387,334
)
(
409,713
)
Total Stockholders’ Equity
30,302
7,834
Total Liabilities and Stockholders’ Equity
$
40,157
$
51,775
See
accompanying notes to the condensed consolidated financial statements.
2
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
(amounts
in thousands, except share and per share data)
For
the
Three Months Ended
June 30,
For
the
Six Months Ended
June 30,
2026
2025
2026
2025
Revenue
Revenue
$
-
$
-
$
-
$
-
Other revenue
35,000
-
35,000
-
Total revenue
35,000
-
35,000
-
Operating
expenses:
Research and development, net of reimbursements
5,377
4,879
9,578
12,579
General and administrative
2,058
2,624
3,760
11,562
Total operating expenses
7,435
7,503
13,338
24,141
Income/(Loss) from operations
27,565
(
7,503
)
21,662
(
24,141
)
Other
income:
Interest income - net
336
625
717
1,325
Total other income
336
625
717
1,325
Income/(loss) before income taxes
27,901
(
6,878
)
22,379
(
22,816
)
Income tax expense
-
-
-
-
Net income/(loss)
$
27,901
$
(
6,878
)
$
22,379
$
(
22,816
)
Net income/(loss) per common share – basic
$
0.89
$
(
0.22
)
$
0.71
$
(
0.73
)
Weighted average common shares outstanding – basic
31,399,086
31,195,891
31,318,830
31,195,891
Net income/(loss) per common share – fully diluted
$
0.89
$
(
0.22
)
$
0.71
$
(
0.73
)
Weighted average common shares outstanding – fully diluted
31,406,740
31,195,891
31,322,144
31,195,891
See
accompanying notes to the condensed consolidated financial statements.
3
Actinium
Pharmaceuticals, Inc.
Consolidated Statements of Comprehensive Income/(Loss)
(amounts
in thousands)
For
the
Three Months Ended
June 30,
For
the
Six Months Ended
June 30,
2026
2025
2026
2025
Net Income/(Loss)
$
27,901
$
(
6,878
)
$
22,379
$
(
22,816
)
Other
comprehensive loss:
Foreign currency translation adjustment
(
21
)
-
(
40
)
-
Comprehensive Income/(Loss)
$
27,880
$
(
6,878
)
$
22,339
$
(
22,816
)
See
accompanying notes to the condensed consolidated financial statements.
4
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statement of Changes in Stockholders’ Equity
For
the Period from January 1, 2026 to June 30, 2026
(Unaudited)
(amounts
in thousands, except share amounts)
Accumulated
Additional
Other
Common
Stock
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balance, January 1, 2026
31,195,891
$
31
$
417,536
$
(
20
)
$
(
409,713
)
$
7,834
Stock-based compensation
179,100
-
11
-
-
11
Net loss
-
-
-
-
(
5,522
)
(
5,522
)
Unrealized loss on foreign currency translation
-
-
-
(
19
)
-
(
19
)
Balance, March 31, 2026
31,374,991
$
31
$
417,547
$
(
39
)
$
(
415,235
)
$
2,304
Stock-based compensation
66,445
-
118
-
-
118
Net income
-
-
-
-
27,901
27,901
Unrealized loss on foreign currency translation
-
-
-
(
21
)
-
(
21
)
Balance, June 30, 2026
31,441,436
$
31
$
417,665
$
(
60
)
$
(
387,334
)
$
30,302
See
accompanying notes to the condensed consolidated financial statements.
5
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statement of Changes in Stockholders’ Equity
For
the Period from January 1, 2025 to June 30, 2025
(Unaudited)
(amounts
in thousands, except share amounts)
Accumulated
Additional
Other
Common
Stock
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balance, January 1, 2025
31,195,891
$
31
$
408,553
$
-
$
(
375,826
)
$
32,758
Stock-based compensation
-
-
8,874
-
-
8,874
Net loss
-
-
-
-
(
15,938
)
(
15,938
)
Balance, March 31, 2025
31,195,891
$
31
417,427
-
(
391,764
)
25,694
Stock-based compensation
-
-
197
-
-
197
Net loss
-
-
-
-
(
6,878
)
(
6,878
)
Balance, June 30, 2025
31,195,891
$
31
$
417,624
$
-
$
(
398,642
)
$
19,013
See
accompanying notes to the condensed consolidated financial statements.
6
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
(amounts
in thousands)
For
the
Six
Months Ended
June
30,
2026
2025
Cash Flows Used in Operating
Activities:
Net income/(loss)
$
22,379
$
(
22,816
)
Adjustments to reconcile
net loss to net cash used in operating activities:
Stock-based compensation expense
129
9,071
Depreciation and amortization expenses
461
409
Changes in operating assets
and liabilities:
Prepaid expenses and other current assets
116
501
Accounts payable and accrued expenses
1,214
147
Operating lease liabilities
(
348
)
(
278
)
Long-term license revenue deferred
(
35,000
)
-
Net Cash Used in Operating Activities
(
11,049
)
(
12,966
)
Cash Flows Used in Investing
Activities:
Purchase of property and equipment
(
480
)
-
Net Cash Used in Investing Activities
(
480
)
-
Cash Flows Used in Financing
Activities:
Payments on finance leases
(
5
)
(
5
)
Net Cash Used in Financing Activities
(
5
)
(
5
)
Effect of foreign currency rates on cash
13
-
Net Change in Cash, Cash Equivalents and Restricted Cash
(
11,521
)
(
12,971
)
Cash, cash equivalents and restricted cash at beginning of year
48,333
73,228
Cash, Cash Equivalents and Restricted Cash at End of Period
$
36,812
$
60,257
See
accompanying notes to the condensed consolidated financial statements.
7
Actinium
Pharmaceuticals, Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note 1 - Description of Business and Summary of Significant Accounting Policies
Nature of Business
- Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company pioneering the development of targeted radiotherapies to address significant unmet medical needs in oncology.
Basis of Presentation - Unaudited Interim Financial Information -
The accompanying unaudited interim condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information, and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”) with respect to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim condensed consolidated financial statements furnished reflect all adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Principles of Consolidation -
The basis of consolidation is unchanged from the disclosure in the Company’s Notes to the Consolidated Financial Statements section in its Annual Report on Form 10-K for the year ended December 31, 2025. The unaudited condensed consolidated financial statements include the Company’s accounts and those of the Company’s wholly owned subsidiaries.
Use of Estimates
- The preparation of these unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the unaudited interim condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Segment Information -
The Company operates as a single operating and reportable segment for the purposes of assessing performance and allocating resources. The Company’s chief operating decision maker is its Chief Executive Officer, who reviews total assets in the consolidated balance sheets and net income/(loss) and its components in the consolidated statements of operations; research and development expenses, general and administrative expenses, and interest income, for the purposes of making operating decisions, assessing financial performance, and allocating resources.
Virtually all of the Company’s assets are located in the United States, with an immaterial amount held by its wholly owned Australian subsidiary, Actinium Pharmaceuticals Australia Pty Ltd, which supports certain international clinical development activities.’
Cash, Cash Equivalents and Restricted Cash -
The Company considers all highly liquid accounts with original maturities of three months or less to be cash equivalents. The Company holds most of its cash equivalents in a money market account comprised of US Treasury notes. Balances held by the Company are typically in excess of Federal Deposit Insurance Corporation insured limits.
The following is a summary of cash, cash equivalents and restricted cash at June 30, 2026 and December 31, 2025:
(in thousands)
June 30,
2026
December 31,
2025
Cash and cash equivalents
$
36,473
$
47,998
Restricted cash – long-term
339
335
Cash, cash equivalents and restricted cash
$
36,812
$
48,333
8
Restricted cash relates to a certificate of deposit held as collateral for a letter of credit issued in connection with the Company’s lease of corporate office space.
Leases
– The Company has an operating lease for corporate office space, an operating lease for manufacturing space and a finance lease for office equipment located at the corporate office space. Leases with an initial term of 12 months or less are not recorded on the balance sheet; lease expense for these leases is recognized on a straight-line basis over the lease term.
Fair Value Measurement -
Fair value is defined as the price that would be received to sell an asset, or paid to transfer a liability, in an orderly transaction between market participants. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.
Revenue Recognition
- The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606,
Revenue From Contracts With Customers
(“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue as the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses whether the promised goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. In determining whether goods or services are distinct, the Company evaluates certain criteria, including whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (capable of being distinct) and (ii) the good or service is separately identifiable from other goods or services in the contract (distinct in the context of the contract).
The Company then determines the transaction price, which is the amount of consideration it expects to be entitled from a customer in exchange for the promised goods or services for each performance obligation and recognizes the associated revenue as each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which it expects to be entitled. Variable consideration includes payments in the form of collaboration milestone payments. If an arrangement includes collaboration milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price.
ASC 606 requires the Company to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in the revenue standard as the price at which an entity would sell a promised good or service separately to a customer. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation as each performance obligation is satisfied, either at a point in time or over time, and if over time, recognition is based on the use of an output or input method.
9
Collaborative Arrangements
- The Company follows the accounting guidance for collaboration agreements with third parties, which requires that certain transactions between the Company and collaborators be recorded in its consolidated statements of operations on either a gross basis or net basis, depending on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships. The Company evaluates its collaboration agreements for proper classification in its consolidated statements of operations based on the nature of the underlying activity. When the Company has concluded that it has a customer relationship with one of its collaborators, the Company follows the guidance of ASC 606
.
There was no revenue from collaborative arrangements for the three months and six months ended June 30, 2026 and June 30, 2025, respectively.
Grant Revenue
–
The Company has a grant from a government-sponsored entity for research and development related activities that provides for payments for reimbursed costs, which included overhead and general and administrative costs as well as an administrative fee. The Company recognizes revenue from grants as it performed services under this arrangement. Associated expenses are recognized when incurred as research and development expense. Revenue and related expenses are presented gross in the consolidated statements of operations.
There was no grant revenue for the three months and six months ended June 30, 2026 and June 30, 2025, respectively.
License Revenue
–
The Company entered into a product licensing agreement whereby the Company allowed a third party to commercialize a certain product in specified territories using the Company’s trademarks. The terms of this arrangement includes payment to the Company for a combination of one or more of the following: upfront license fees; development, regulatory and sales-based milestone payments; and royalties on net sales of licensed products. The Company uses its judgment to determine whether milestones or other variable consideration should be included in the transaction price.
Upfront license fees
: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenue from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time.
Development, regulatory or commercial milestone payments
: At the inception of each arrangement that includes payments based on the achievement of certain development, regulatory and sales-based or commercial events, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until regulatory approval is received. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achieving such development and regulatory milestones and any related constraint, and if necessary, adjust the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis and recorded as part of license revenue during the period of adjustment.
Sales-based milestone payments and royalties
: For arrangements that include sales-based royalties, including milestone payments based on the volume of sales, the Company will determine whether the license is deemed to be the predominant item to which the royalties or sales-based milestones relate and if such is the case, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Upfront payments and fees may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements or when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur or when the uncertainty associated with any variable consideration is subsequently resolved. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. License revenue for the three months and six months ended June 30, 2026 was $
35.0
million, see Note 4. There was no license revenue for the six months ended June 30, 2025.
10
Research and Development Costs -
Research and development costs are expensed as incurred.
Research and development costs include clinical site operations, contract research organizations, manufacturing, isotope supply, investigational product logistics, regulatory support, pharmacovigilance and other development activities conducted in the United States and internationally. To the extent the Company becomes eligible for research and development tax incentives, including incentives available in Australia, such amounts will be recognized in accordance with applicable accounting guidance when realization is probable and the amount can be reasonably estimated.
Share-Based Payments -
The Company estimates the fair value of each stock option award at the grant date by using the Black-Scholes option pricing model. The fair value determined represents the cost for the award and is recognized over the vesting period during which an employee is required to provide service in exchange for the award. The Company accounts for forfeitures of stock options as they occur.
Net Income/(Loss) Per Common Share
- Basic net income and net loss per common share are computed by dividing the net income or net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the reporting period. For periods with net income, diluted net income per common share is computed using the treasury stock method for stock options and warrants that are dilutive (i.e., where the exercise price is below the average market price of the Company’s common stock for the period). For periods with net loss, diluted net loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive. For the three months and six months ended June 30, 2026, the Company included
284
thousand and
279
thousand stock options, respectively, in the computation of diluted net income per share using the treasury stock method.
For the three months and six months ended June 30, 2025, all potentially dilutive shares, including outstanding common stock options, restricted stock units, and warrants, were excluded from the computation of diluted net loss per share as the result would have been anti-dilutive.
Three months ended
Six months ended
(in thousands)
June 30,
2026
June 30,
2025
June 30,
2026
June 30,
2025
Stock Options included in calculation of Fully diluted net income per share
284
-
279
-
Securities excluded as anti-dilutive (exercise price exceeds average market price):
Stock Options
95
240
100
240
Restricted Stock Units
-
300
-
300
Warrants
7
7
7
7
Total
102
547
107
547
Recently Issued Accounting Pronouncements
In September 2025, the FASB issued ASU 2025-07,
Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract
, which excludes from derivative accounting non-exchange-traded contracts with underlying terms that are based on operations or activities specific to one of the parties to the contract. However, this scope exception does not apply to (1) variables based on a market rate, market price, or market index, (2) variables based on the price or performance of a financial asset or financial liability of one of the parties to the contract, (3) contracts (or features) involving the issuer’s own equity that are evaluated under the guidance in Subtopic 815-40,
Derivatives and Hedging—Contracts in Entity’s Own Equity,
and (4) call options and put options on debt instruments. The Company can apply the amendments in ASU 2025-07 either (1) prospectively to new contracts entered into on or after the date of adoption or (2) on a modified retrospective basis through a cumulative-effect adjustment to the opening balance of retained earnings as of the beginning of the annual reporting period of adoption for contracts existing as of the beginning of the annual reporting period of adoption. The amendments in ASU 2025-07 are effective January 1, 2027, for annual reporting periods, including interim periods within annual reporting periods. Early adoption is permitted. The Company is evaluating the impact of ASU 2025-07 on its financial statements.
11
In May 2025, FASB issued ASU 2025-04,
Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Clarifications to Share-Based Consideration Payable to a Customer
, which revises the Master Glossary definition of the term “performance condition” for share-based consideration payable to a customer to include conditions, such as vesting conditions, that are based on the volume or monetary amount of a customer’s purchases or potential purchases of goods or services from the grantor, including over a specified period of time. The revised definition also incorporates performance targets based on purchases made by other parties that purchase the grantor’s goods or services from the grantor’s customers. The revised definition of the term performance condition cannot be applied by analogy to awards granted to employees and non-employees in exchange for goods or services to be used or consumed in the grantor’s own operations. ASU 2025-04 eliminates the policy election permitting a grantor to account for forfeitures as they occur for share-based awards granted to a customer. Separate policy elections for forfeitures remain available for share-based payment awards with service conditions granted to employees and non-employees in exchange for goods or services to be used or consumed in the grantor’s own operations. ASU 2025-04 further clarifies that a grantor should not apply the guidance in Topic 606 on constraining estimates of variable consideration to share-based consideration payable to a customer. ASU 2025-04 permits a grantor to apply the new guidance on either a modified retrospective or a retrospective basis. The amendments in ASU 2025-04 are effective January 1, 2027 for annual reporting periods, including interim periods within annual reporting periods. The Company is evaluating the impact of ASU 2025-04 on its financial statements.
In November 2024, FASB issued ASU 2024-03,
Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures
(Subtopic 220-40), to improve the disaggregation of expenses within the consolidated statement of operations. The amendments in ASU 2024-03 require disclosures in the notes to the consolidated financial statements and specified information about certain costs and expenses. The amendments require that at each interim and annual reporting period an entity disclose (a) employee compensation, (b) depreciation, and (c) intangible asset amortization included in each relevant expense caption; include certain amounts that are already required to be disclosed under current GAAP in the same disclosure as the other disaggregation requirements; and disclose a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively. The amendments in ASU 2024-03 are effective January 1, 2027 and effective for interim periods beginning January 1, 2028, either on a prospective or retrospective basis. The Company is evaluating the impact of ASU 2024-03 on its financial statements.
In December 2025, the FASB issued ASU 2025-11,
Interim Reporting
(Topic 270): Narrow-Scope Improvements. This update clarifies interim disclosure requirements and centralizes such requirements within Topic 270. Among other changes, ASU 2025-11 introduces a disclosure principle requiring entities to provide information about significant events or changes since the end of the last annual reporting period that have a material impact, clarifies when duplicative annual disclosures may be omitted from interim reports, and aligns interim reporting requirements with applicable SEC guidance for registrants. This guidance is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments in ASU 2025-11 should be applied prospectively. The Company is currently assessing the impact on its condensed consolidated financial statements and disclosures.
Note 2 - Commitments and Contingencies
On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (“FHCRC”) to build upon previous and ongoing clinical trials with apamistamab (licensed antibody). FHCRC has completed both a Phase 1 and Phase 2 clinical trial with apamistamab. The Company has been granted exclusive rights to the antibody and related master cell bank developed by FHCRC. A milestone payment of $
1
million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed antibody. Upon commercial sale of the drug, royalty payments of
2
% of net sales will be due to FHCRC.
On June 25, 2024, the Company entered into an exclusive, worldwide license agreement with a third party for rights to develop and commercialize radiopharmaceutical products incorporating a licensed monoclonal antibody. Under the agreement, the Company made an upfront payment, which was recorded as research and development expense, and may be required to make future milestone and royalty payments upon the achievement of specified development, regulatory and commercial events and upon commercial sales.
12
On March 27, 2025, a putative class action complaint (the “Securities Complaint”) was filed by alleged stockholder Nitin Kohil against the Company and executives Sandesh Seth, Avinash Desai, Madhuri Vusirikala, and Sergio Giralt (the “Defendants”), styled
Kohil v. Actinium Pharmaceuticals, Inc., et al
., Case No. 1:25-cv-02553 in the United States District Court for the Southern District of New York, (“the Court”). The Securities Complaint alleges that the Defendants made material misrepresentations and omissions concerning the Iomab-B Phase 3 Sierra Trial during a proposed class period of October 31, 2022 to August 2, 2024 and asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. Plaintiff sought unspecified damages. On June 24, 2025, the court in the securities action appointed lead plaintiffs pursuant to the Private Securities Litigation Reform Act of 1995 and re-captioned the case as
In re Actinium Pharmaceuticals, Inc. Securities Litigation
. Lead Plaintiffs filed an amended complaint on August 25, 2025. On October 27, 2025, Defendants moved to dismiss the amended complaint; on December 19, 2025, Lead Plaintiffs filed their opposition; and on February 2, 2026, Defendants filed their reply in support. The parties are currently awaiting the Court’s decision on Defendants’ motion.
On May 5, 2025, a shareholder complaint captioned
Georges v. Seth et al.
, Case No. 1:25-cv-03738-JPO was filed against certain of the Company’s directors and officers, alleging derivative liability based on the same factual allegations made in the securities class action. On May 13, 2025, a second substantially identical derivative complaint captioned
Robinson v. Seth et al
., Case No. 1:25-cv-04012-JPO was filed. On June 24, 2025, the Court consolidated the derivative cases and, on July 29, 2025, the parties to the derivative cases filed a stipulation with the Court to stay those matters pending resolution of the motion that defendants will file in the securities class action. The Court so-ordered that stipulation on July 30, 2025, and re-captioned the case as
In re Actinium Pharmaceuticals, Inc. Derivative Litigation.
On June 17, 2025, a purported shareholder served Actinium with a demand for books and records pursuant to Section 220 of the Delaware General Corporation Law. In general, the demand seeks documents relating to the facts at issue in the above-described securities class action and derivative cases. The Company rejected the shareholder demand by letter dated July 8, 2025. The parties continue to discuss the demand. The shareholder has not followed up on his demand since October 2025.
The Company and other Defendants intend to defend vigorously against such claims, however, there can be no assurances as to the outcome.
As of June 30, 2026, the Company had contractual commitments of approximately $
1.5
million related to the equipment purchase and construction of its newly leased manufacturing facility. Of this amount, approximately $
0.6
million had been incurred through June 30, 2026, with the remaining $
0.9
million anticipated to be incurred during the second half of 2026.
Note 3 - Leases
The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of a fixed asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company has lease agreements which include lease and non-lease components, which the Company has elected to account for as a single lease component for all classes of underlying assets. Lease expense for variable lease components are recognized when the obligation is probable. The Company made an accounting policy election to exclude from its balance sheet reporting those leases with initial terms of 12 months or less.
Right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s leases, the incremental borrowing rate was used based on the information available at commencement date in determining the present value of lease payments.
The lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option to extend (or not to terminate) the lease controlled by the lessor. Options for lease renewals have been excluded from the lease term (and lease liability) for the Company’s leases as the reasonably certain threshold is not met.
As of June 30, 2026, the Company has three leases which have been capitalized in accordance with ASC 842, one for corporate office space, one for manufacturing space and one for office equipment. The Company entered into a lease for corporate office space effective June 1, 2022. The lease has a term of
five years and two months
, with an expiration date of
July 30, 2027
and current annual rent of $
0.6
million. The Company is also responsible for certain other costs, such as insurance, utilities and maintenance. The Company entered into a lease for manufacturing space effective as of December 1, 2025. The lease has a term of
five years
and
one month
, with an expiration date of
December 31, 2030
and current annual rent of $
0.2
million. The Company is also responsible for certain other costs, such as insurance, utilities and maintenance.
13
The components of lease expense are as follows:
Three months ended
Six months ended
(in thousands)
June 30,
2026
June 30,
2025
June 30,
2026
June 30,
2025
Operating lease expense
$
218
$
173
$
437
$
346
Finance lease cost
Amortization of right-to-use assets
$
2
$
2
$
5
$
5
Interest on lease liabilities
$
-
$
-
$
1
$
1
Total finance lease cost
$
2
$
2
$
6
$
6
Supplemental cash flow information related to leases are as follows:
Cash flow information:
Six months ended
(in thousands)
June 30,
2026
June 30,
2025
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$
404
$
313
Operating cash flow use from finance leases
$
5
$
5
Financing cash flow use from finance leases
$
5
$
5
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$
-
$
-
Finance Leases
$
-
$
-
Weighted average remaining lease terms are as follows at June 30, 2026:
Weighted average remaining lease term:
Operating leases
2.7
years
Finance Leases
0.5
year
As the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s incremental borrowing rate was based on the term of the lease, the economic environment of the lease and reflects the rate the Company would have had to pay to borrow on a secured basis.
Below is information on the weighted average discount rates used at the time that the leases were evaluated:
Weighted average discount rates:
Operating leases
6.0
%
Finance Leases
6.2
%
14
Maturities of lease liabilities are as follows:
(in thousands)
Year ending December 31,
Operating
Leases
Finance
Leases
2026 (excluding six months ended June 30, 2026)
410
5
2027
557
-
2028
182
2029
187
2030
193
-
Total lease payments
$
1,529
$
5
Less imputed interest
(
193
)
-
Present value of lease liabilities
$
1,336
$
5
Note 4 - Other revenue
The Company has a grant from a government-sponsored entity for research and development related activities that provides payments for reimbursed costs, which included overhead and general and administrative costs, as well as an administrative fee. The Company recognizes revenue from grants as it performs services under this arrangement. Associated expenses are recognized when incurred as research and development expense. There was no grant revenue recognized for the three months and six months ended June 30, 2026 and 2025, respectively.
On April 7, 2022, the Company entered into a license and supply agreement (the “License Agreement”) with Immedica Pharma AB (“Immedica”), pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B (I-131 apamistamab) in the European Economic Area, Middle East and North Africa (“EUMENA”), including Algeria, Andorra, Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen. Upon signing, the Company was entitled to an upfront, non-refundable payment of $
35
million from Immedica, which was received in May 2022. Under the terms of the License Agreement, the Company was eligible to receive certain regulatory and commercial milestone payments and royalties on net sales of the product in the licensed territories. The Company continues to retain commercialization rights in the United States and the rest of the world. The $
35
million upfront payment was initially recorded as Long-term license revenue - deferred due to uncertainty regarding Immedica’s ability to obtain regulatory approval of the product by the European Medicines Agency. Subsequently, Immedica notified the Company that it would not pursue regulatory approval of Iomab-B in the licensed territories. In the current period, based on the facts and circumstances, the Company concluded that Immedica’s right to asserting a claim related to the $35 million had expired. Accordingly, the condition previously constraining recognition of the $
35
million upfront payment no longer existed and that the non-refundable payment was no longer subject to a significant reversal. Therefore, the Company recognized the previously deferred $
35
million upfront payment as revenue in June 2026.
Note 5 - Equity
In August 2020, the Company entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, “JonesTrading”, pursuant to which the Company may sell, from time to time, through or to JonesTrading, up to an aggregate of $
200
million of its common stock. On June 28, 2022, the Company entered into an Amended and Restated Capital on Demand™ Sales Agreement (the “A&R Sales Agreement”) with JonesTrading and B. Riley Securities, Inc. (“B. Riley”). The A&R Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B. Riley Securities as an additional sales agent thereunder. Shares of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-242322) filed with the SEC on August 7, 2020 (the “Prior Shelf Registration Statement”). On August 11, 2023, the Company filed a registration statement on Form S-3 (File No. 333-273911), which registration statement was amended on February 2, 2024, and declared effective on February 5, 2024, to replace the Prior Shelf Registration Statement, including a base prospectus which covers the offering, issuance and sale of up to $
500
million of common stock, preferred stock, warrants, units and/or subscription rights; and a sales agreement prospectus covering the offering, issuance and sale of up to a maximum aggregate offering price of $
200
million of common stock that may be issued and sold under the A&R Sales Agreement.
The Company did not sell any shares of common stock during the six months ended June 30, 2026 and 2025, respectively.
15
Stock Options
The following is a summary of stock option activity for the six months ended June 30, 2026:
(in thousands, except for per-share amounts)
Number of
Shares
Weighted
Average
Exercise
Price ($)
Weighted
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value
Outstanding, January 1, 2026
99
$
5.89
7.66
$
-
Granted
284
1.15
Exercised
-
-
Cancelled
(
4
)
43.05
Outstanding, June 30, 2026
379
1.99
9.25
-
Exercisable, June 30, 2026
50
6.57
5.95
-
During the six months ended June 30, 2026, the Company granted newly hired employees options to purchase
284
thousand shares of common stock with an exercise price ranging from $
1.00
to $
1.28
per share, a term of
10
years, and a vesting period of
4
years. The stock options had an aggregate fair value of $
242
thousand that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate range from
3.7
% to
4.2
%, (2) expected life of
6
years, (3) expected volatility range from
85.8
% to
87.3
%, and (4)
zero
expected dividends. During the six months ended June 30, 2025, the Company granted options to purchase
26
thousand shares.
On March 31, 2025, the Board of Directors approved of the cancellation of stock options to purchase an aggregate of
4.9
million shares of common stock held by certain current employees and directors that were initially granted under the Amended and Restated 2013 Stock Plan and the 2019 Stock Plan. Such cancellations were subject to the consent of the applicable holders of the stock options, which the Company received. The cancellation of these stock options resulted in the recording of $
8.7
million in stock compensation expense for the six months ended June 30, 2025.
The fair values of all options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at June 30, 2026 was $
0.3
million related to unvested stock options, which is expected to be expensed over a weighted average of
3.6
years.
Warrants
Following is a summary of warrant activity for the six months ended June 30, 2026:
(in thousands, except for per-share amounts)
Number of
Shares
Weighted
Average
Exercise
Price ($)
Weighted
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value
Outstanding, January 1, 2026
7
$
17.33
3.45
$
-
Granted
-
-
Expired
-
-
Outstanding, June 30, 2026
7
$
17.33
3.00
$
-
Exercisable, June 30, 2026
7
$
17.33
3.00
$
-
16
Note 6 – Income Taxes
The Company accounts for income taxes under ASC 740,
Income Taxes
. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, as well as for net operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will not be realized.
For interim periods, the Company estimates its annual effective income tax rate and applies that rate to year-to-date ordinary income or loss in determining the income tax provision or benefit for the period.
The Company’s estimated annual effective income tax rate for the year ending December 31, 2026 is
0
%. Although the Company recorded income before income taxes of $
27.9
million and $
22.4
million for the three and six months ended June 30, 2026, respectively, driven by the recognition of $
35.0
million of revenue previously deferred in connection with the commercialization agreement with Immedica, no income tax expense was recorded as the Company has sufficient net operating losses that are available to offset net taxable income. The effective tax rate differs from the U.S. federal statutory rate of
21
% primarily because the Company maintains a full valuation allowance against its net deferred tax assets. As a result, no income tax benefit or expense is recognized on pre-tax income or loss for financial reporting purposes.
Since its inception, the Company has generated net operating losses in substantially all periods and has accumulated significant federal and state net operating loss carryforwards. Based on the weight of all available evidence, including the Company’s history of cumulative losses and the uncertainty of future taxable income sufficient to realize its deferred tax assets, management has determined that it is more likely than not that the net deferred tax assets will not be realized. Accordingly, a full valuation allowance has been maintained against all net deferred tax assets. The recognition of the $
35.0
million of deferred revenue as income for the three months and six months ended June 30, 2026 does not, in isolation, constitute sufficient positive evidence to conclude that realization of the Company’s deferred tax assets is more likely than not, and therefore the full valuation allowance has been maintained as of June 30, 2026.
17
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENT NOTICE
This
Quarterly Report on Form 10-Q and other reports filed by the Company from time to time with the Securities and Exchange Commission contains
or may contain certain forward-looking statements and information that are based upon beliefs of, and information currently available
to the Company’s management as well as estimates and assumptions made by the Company’s management. Readers are cautioned
not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. For
this purpose, any statements contained in this Quarterly Report on Form 10-Q that are not statements of historical fact may be deemed
to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,”
“believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended
to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual
results may differ materially depending on a variety of factors, many of which are not within our control. These factors include
but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen
industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results,
levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States,
we do not intend to update any of the forward-looking statements to conform these statements to actual results.
Description
of Business
We
are a clinical-stage biopharmaceutical company pioneering the development of targeted radiotherapies to address significant unmet medical
needs in oncology. We are focused on employing a biology-driven approach to develop differentiated, first-in-class radiopharmaceutical
therapeutics for patients with solid tumors and hematologic malignancies. Our mission is to transform cancer treatment by delivering
innovative, high-value, radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining our
deep understanding of tumor biology and translational medicine with our expertise in radiochemistry.
Since
our inception, we have focused on developing innovative and differentiated radiotherapies. Our pipeline of both early and later stage
development programs is a testimony to our approach in three areas with: (1) two novel solid tumor product candidates, ATNM-400 and Actimab-A,
with pan-tumor potential, (2) Actimab-A, which is also being developed as a therapeutic backbone for acute myeloid leukemia (AML) and
myelodysplastic syndrome (MDS) in partnership with the National Cancer Institute (NCI), and (3) two targeted conditioning agents, Iomab-B
for bone marrow transplant and Iomab-ACT for cell & gene therapies. Our solid tumor asset, ATNM-400, targets a novel antigen distinct
from PSMA, with demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung
cancer (NSCLC), and breast cancer. Actimab-A targets myeloid derived suppressor cells (MDSCs) and is being studied in multiple solid
tumors in combination with immune checkpoint inhibitors where MDSCs are known to act as an efficacy deterrent for these agents. Our hematology
franchise includes: Actimab-A, a CD33-targeted therapy; as well as, Iomab-B and Iomab-ACT which are CD45-targeting conditioning agents.
Both Actimab-A and Iomab-B are Phase 2/3 ready assets and are supported by extensive validation in over 15 clinical trials in which more
than 500 patients were treated. We have several ongoing clinical studies across our pipeline. We expect to report data from ongoing company-
and investigator-sponsored clinical studies for ATNM-400, Actimab-A for MDSC’s and Iomab-ACT in 4Q:2026 and over the course of
2027.
18
ATNM-400:
First-in-Class Pan-Tumor Radiotherapy
ATNM-400
is our lead solid tumor program, representing a first-in-class Ac-225 antibody radioconjugate targeting a novel, undisclosed antigen
with expression across multiple solid tumor types. The ATNM-400 target is implicated in disease biology during tumor progression and
is also overexpressed when tumors become resistant to many approved therapies in multiple solid tumors. We are developing ATNM-400 as
a potential pan-cancer, biology-driven therapy - alone or in combination with standard-of-care agents - for large, treatment
resistant-solid tumor populations across prostate, NSCLC, breast cancer and potentially other sizable cancer indications.
Our
translational data demonstrated that ATNM-400 is superior to the active ingredients in the many of the most commonly prescribed approved
therapies in prostate cancer, NSCLC and breast cancer when tested in a wide variety of preclinical models:
●
Prostate Cancer:
PSMA-targeted agents (177Lu-PSMA-617 (the active ingredient in Pluvicto
®
) and 225Ac-PSMA-617) and ARPIs (enzalutamide,
apalutamide, darolutamide) in the mCRPC setting of prostate cancer;
●
NSCLC:
EGFR inhibitors (osimertinib),
osimertinib with chemotherapy, TROP-2 ADC (Dato-DXd), EGFR-cMET bispecific (amivantamab), HER3-EGFR bispecific antibody drug conjugate
(ADC) (izalontamab brengitecan, in development) in EGFR-mutant NSCLC, and KRAS-G12C inhibitors (sotorasib and adagrasib) in KRAS-G12C
mutant NSCLC; and
●
Breast
Cancer:
HER2 therapies (trastuzumab and T-DXd) in HER2 resistant breast cancer and endocrine therapy (tamoxifen) in tamoxifen-resistant
breast cancer.
These
preclinical translational data show that ATNM-400 works well as monotherapy but is even better in combination in resistant settings where
the target is overexpressed as part of the resistance mechanism of several of the approved standard-of-care drugs. Evidence of ATNM-400
target expression has been observed ranging from 60%-80% of mCRPC, >90% of NSCLC, and 50-70% of breast cancer patient tumors, representing
a significant addressable population of well over a hundred thousand patients in the United States based on existing datasets. We believe
this number may expand as we continue our work to demonstrate the potential of ATNM-400 in various additional disease and treatment settings.
In
addition, we have developed a theranostic strategy utilizing Zr-89 as a companion imaging agent to enable patient selection and tumor
visualization. We believe this approach allows for non-invasive assessment of target expression and drug biodistribution prior to therapeutic
administration, potentially enhancing the therapeutic index by selecting patients most likely to respond.
Market
Opportunity
ATNM-400
Is Designed to Address Large, Treatment Resistant Patient Populations Across Prostate, Lung and Breast Cancer - Indications in Which
Approved Targeted Therapies Generated More Than $30 Billion in Worldwide Sales in 2025
We
are developing ATNM-400 as a mutation- and pathway-agnostic radiotherapeutic - as a monotherapy or in combination with standard of
care - for large, treatment resistant solid tumor populations, with initial focus on prostate cancer, non-small cell lung
cancer (NSCLC) and breast cancer. These diseases have been selected for initial clinical development driven by a common scientific
and commercial rationale. Each disease represents a large, well-established market due to targeted agents and yet a major
underserved opportunity once their resistance to these therapies develops. The antigen targeted by ATNM-400 is expressed in all
these disease areas and its expression further increases in many cases as the existing therapies fail. Several of these therapies
have blockbuster sales generated by treating a large number of patients. ATNM-400 target expression is reported in a majority of
prostate cancer, NSCLC and breast cancer tumors based on immunohistochemistry datasets, which we estimate corresponds to an
addressable population of well over 350,000 patients per year in the United States across these three indications and considerably
more worldwide. We believe this addressable population may expand as we evaluate ATNM-400 in additional indications and treatment
settings.
19
Prostate
Cancer
Prostate
cancer is the most frequently diagnosed cancer in men in the United States. According to the American Cancer Society, approximately 333,830
men in the United States were estimated to be diagnosed with prostate cancer in 2026, representing approximately 30% of all cancer diagnoses
in men. While localized prostate cancer is frequently curable, metastatic disease is not: approximately 5% to 7% of patients present
with metastatic disease at initial diagnosis, and approximately 20% to 30% of patients initially diagnosed with localized disease subsequently
progress to metastatic disease, for which available therapies slow, but do not cure, disease progression.
Because
prostate cancer cells rely on androgens for growth, most patients receive androgen receptor pathway inhibitor (ARPI) therapy, including
enzalutamide (Xtandi
®
), apalutamide (Erleada
®
) and darolutamide (Nubeqa
®
), which generated
more than $6.3 billion, $3.6 billion and $2.7 billion in worldwide sales, respectively, in 2025. We estimate that up to approximately
50,000 to 60,000 men in the United States progress following ARPI therapy each year. Collectively, ARPIs generated more than $12 billion
in worldwide sales in 2025.
Since
the March 2022 approval of the PSMA-directed radioligand therapy Pluvicto
®
(with active ingredient Lu177-PSMA-617),
targeted radiotherapy has become a prominent component of the metastatic castration-resistant prostate cancer (mCRPC) treatment
paradigm. Pluvicto
®
, marketed by Novartis, generated approximately $2.0 billion in worldwide sales in 2025, and its
addressable population has expanded from approximately 44,000 patients toward approximately 86,500 patients with successive label
expansions into earlier lines of therapy. More than 30 PSMA-targeted radiotherapies are currently in various stages of development.
Notwithstanding this activity, we believe a significant unmet need remains: we estimate that approximately 30% of patients with
mCRPC have low or no PSMA expression and are therefore poorly served by PSMA-directed radioligand therapies, and re-treatment with
PSMA-directed agents may be limited by reduced PSMA surface expression and increased tumor heterogeneity following initial
PSMA-targeted therapy. In addition, because PSMA is expressed in the salivary glands, PSMA-directed radiotherapies are associated
with xerostomia, a quality-of-life limitation that is particularly relevant for Ac-225-based PSMA agents.
Because
ATNM-400 is directed against a novel, non-PSMA antigen and acts independently of both androgen receptor (AR) signaling and PSMA expression,
we believe it is positioned to address the full metastatic castration-resistant prostate cancer (mCRPC) treatment continuum. This includes
patients whose disease has progressed on androgen receptor pathway inhibitors (ARPIs), as well as patients with PSMA-low or PSMA-negative
tumors, for whom there are very limited commercially available targeted radiotherapy options. Together, these patient populations represent
a combined opportunity that we estimate exceeds 100,000 patients annually in the United States and may be addressable with ATNM-400 as
either a monotherapy or in combination with existing standards of care.
20
Non-Small
Cell Lung Cancer
Lung
cancer is the leading cause of cancer death worldwide. Approximately 229,410 new cases of lung cancer were estimated to be diagnosed
in the United States in 2026, and NSCLC accounts for approximately 85% of the more than two million lung cancer cases diagnosed globally
each year. Approximately 70% are either diagnosed with advanced/metastatic disease or progress to advanced metastatic disease. NSCLC
is a large and heterogeneous market in which no single mutation dominates. EGFR and KRAS mutations together account for approximately
50% to 60% of NSCLC cases, and existing therapies are segmented by mutation subtype and ultimately limited by acquired resistance.
Beyond
EGFR and KRAS Driver Mutations the NSCLC Market is Fragmented
Source:
Adapted from Fregni M, et al. Int J Mol Sci. 2022;23:7213, based on Skoulidis F and Heymach JV. Nat Rev Cancer. 2019;19:495–509
Current
targeted therapies illustrate both the scale of the market and the treatment resistant- unmet need. In EGFR-mutant NSCLC, nearly all
patients receive osimertinib (Tagrisso
®
) as first-line therapy; osimertinib generated approximately $7.3 billion in worldwide
sales in 2025. Disease progression on osimertinib is common and the resistance mechanisms are highly heterogeneous; in the second-line
setting, amivantamab (Rybrevant
®
) plus chemotherapy became a National Comprehensive Cancer Network (NCCN)- preferred regimen
following its September 2024 approval, and datopotamab deruxtecan (Datroway
®
, a TROP-2 antibody-drug conjugate) received
accelerated approval in patients with prior platinum chemotherapy in June 2025, yet a significant unmet need remains for durable
options beyond chemotherapy. Separately, the KRAS-inhibitor class in NSCLC, led by sotorasib (Lumakras
®
) and adagrasib
(Krazati
®
), is conservatively projected to exceed $3 billion in peak sales by 2032.
We
believe ATNM-400 is well suited to this fragmented market. Based on prior immunohistochemistry studies, the antigen targeted by ATNM-400
is expressed in approximately 98% of NSCLC tumors, is highly expressed in approximately 70%, is conserved across EGFR-, KRAS- and other
driver-defined subgroups, and is further increased in tumors that have become resistant to EGFR, KRAS and immune-checkpoint therapies.
Because ATNM-400 addresses NSCLC as a broad, target-defined population rather than as another mutation-specific therapy for a single
molecular subset, we believe its mutation-agnostic profile positions it to participate in these large, established markets as a backbone
therapy - enhancing the standard of care in combination while also reaching the broader NSCLC population beyond any single mutation.
21
Breast
Cancer
Breast
cancer is the most frequently diagnosed cancer among women in the United States. The National Cancer Institute’s Surveillance,
Epidemiology, and End Results (SEER) Program estimates that approximately 321,910 women will be diagnosed with invasive breast cancer
in 2026. Approximately 200,000 women were living with metastatic breast cancer in the United States in 2025, a figure expected to grow
to approximately 250,000 by 2030.
Hormone
receptor-positive, HER2 negative (HR+/HER2−) breast cancer is the largest molecular subtype, accounting for approximately 70% of
newly diagnosed cases. Endocrine therapy is the backbone of treatment, with endocrine therapy plus a CDK4/6 inhibitor preferred for most
patients in the first-line metastatic setting. Approximately half of patients experience disease progression or death within two years,
and the substantial majority progress within five years. Following progression, treatment is guided by prior therapy and biomarkers such
as ESR1, PIK3CA, AKT1, PTEN, and germline BRCA1/2 alterations. Patients with ESR1-mutated disease may receive elacestrant, imlunestrant,
or vepdegestrant, which was approved in May 2026 as the first proteolysis-targeting chimera in oncology. Gedatolisib-based therapy provides
another pathway-targeted option for patients with PIK3CA-wild-type disease, while trastuzumab deruxtecan is approved following endocrine
therapy for HR+, HER2 low or HER2 ultralow disease. Although post-endocrine options have expanded, these approvals were based on progression-free
survival benefits generally measured in months. Median PFS across approved second-line regimens ranges from approximately four to thirteen
months, and substantially all patients ultimately progress. In later lines, datopotamab deruxtecan is approved following endocrine-based
therapy and chemotherapy, while sacituzumab govitecan is approved following endocrine therapy and at least two additional metastatic
systemic regimens. Despite these advances, substantial need remains for therapies that overcome resistance and provide more durable disease
control across successive lines of treatment.
HER2
positive (HER2+) breast cancer accounts for approximately 15% of breast cancers. Although HER2 directed therapies have substantially
improved outcomes, metastatic disease generally remains incurable, and resistance develops across successive regimens. Central
nervous system progression is a major unmet need, with up to 50% of patients developing brain metastases during the course of
disease. Trastuzumab deruxtecan plus pertuzumab was approved in December 2025 as a first-line treatment for unresectable or
metastatic HER2+ breast cancer. Taxane chemotherapy with trastuzumab and pertuzumab remains an option for selected patients.
Trastuzumab deruxtecan plus pertuzumab achieved a median PFS of 40.7 months, compared with 26.9 months for the taxane-based regimen.
Nevertheless, approximately 30% of patients experienced progression or death within two years, and half were expected to do so
within approximately three and a half years. For patients with HR+, HER2+ disease controlled after induction therapy, palbociclib
with trastuzumab, endocrine therapy, and optional pertuzumab was approved in June 2026 as maintenance treatment. Following
progression, treatment depends on prior HER2 directed therapy and the presence or risk of central nervous system disease.
Trastuzumab deruxtecan remains an established second-line option after first-line taxane, trastuzumab, and pertuzumab. However, the
optimal sequence after progression on a first-line trastuzumab deruxtecan-containing regimen has not been established. Later-line
options include tucatinib with trastuzumab and capecitabine, particularly for patients with brain metastases, and other HER2
directed regimens. New agents are needed that remain active following resistance to HER2 directed antibody-drug conjugates and
across successive lines of treatment.
Triple-negative
breast cancer (TNBC), defined by the absence of estrogen receptor, progesterone receptor, and HER2 overexpression or amplification,
accounts for approximately 10% to 15% of breast cancers. TNBC is more aggressive than HR+ breast cancer, carries a higher risk of
early distal recurrence, and lacks endocrine and HER2 directed treatment options. First-line treatment is informed by PD-L1
expression and germline BRCA1/2 mutation status. For patients with PD-L1-positive disease, immune-checkpoint inhibition combined
with systemic therapy is a common strategy. In June 2026, sacituzumab govitecan was approved with pembrolizumab for PD-L1-positive
unresectable locally advanced or metastatic TNBC and as monotherapy for patients who are not candidates for PD-1- or PD-L1-directed
therapy. Datopotamab deruxtecan was also approved in May 2026 for patients who are not candidates for checkpoint inhibition. Despite
these advances, more than half of patients are expected to experience progression or death within one year of starting first-line
treatment. With TROP-2-directed antibody-drug conjugates now used in the first-line setting, no prospectively validated preferred
sequence has been established after progression. Subsequent treatment may include chemotherapy, PARP inhibition for eligible
patients with germline BRCA1/2 mutations, or clinical trials. This sequencing gap and the biological heterogeneity of TNBC support
the need for therapies with mechanisms distinct from TROP-2-directed cytotoxic delivery.
The
antigen targeted by ATNM-400 is expressed across multiple breast cancer subtypes, including HR+/HER2−, HER2+ (including HR+ and
HR-), and triple-negative disease. Based on our preclinical findings, target expression is also retained or increased in tumor models
that have developed resistance to selected standard therapies. We believe ATNM-400’s target-driven, subtype-agnostic profile could
position it to address treatment-resistant breast cancer populations as either a monotherapy or in combination with established standards
of care.
ATNM-400
Positioned to Address HR+/HER2-, HER2+ and TNBC Breast Cancer Subtypes After Resistance to Standard of Care
Source:
American Cancer Society, Cancer Facts & Figures 2026 (Atlanta: American Cancer Society, 2026), estimated new cases of invasive breast
cancer in U.S. women, 2026. Subtype distribution derived from age-adjusted incidence rates for 2019–2023, National Cancer Institute,
SEER Cancer Stat Facts: Female Breast Cancer Subtypes.
22
ATNM-400
Preclinical Data in Large Solid Tumor Indications
Our
preclinical development program has generated encouraging efficacy and mechanism-of-action data across multiple indication-specific animal
models of solid tumors including prostate cancer, NSCLC and breast cancer:
ATNM-400
in Prostate Cancer
ATNM-400
is a first-in-class Ac-225 antibody radioconjugate directed against a novel, non-PSMA antigen implicated in aggressive prostate cancer
biology and overexpressed as tumors progress and develop resistance to standard-of-care therapies. Because ATNM-400 acts independently
of both androgen-receptor signaling and PSMA expression, we believe it has the potential to address patients across the metastatic castration-resistant
prostate cancer, or mCRPC, treatment continuum.
Key
Findings and Therapeutic Positioning in Metastatic Castration-Resistant Prostate Cancer
●
Broad
monotherapy activity across PSMA expression levels.
ATNM-400 demonstrated anti-tumor
activity in PSMA-high, PSMA-low and PSMA-negative mCRPC models. It showed greater efficacy
than 177Lu-PSMA-617 across these models, including in PSMA-low and PSMA-negative disease
where PSMA-directed therapies may have limited activity, and greater efficacy than 225Ac-PSMA-617
in the PSMA-low model.
●
Strong
activity in PSMA-high disease with no xerostomia limitation expected.
In the PSMA-high
model, ATNM-400 demonstrated activity comparable to 225Ac-PSMA-617 and achieved comparable
tumor control to 177Lu-PSMA-617 at approximately one-thousandth of the administered radioactivity.
However, since the ATNM-400 target is not expressed in the salivary glands, we do not expect
ATNM-400 to cause the xerostomia associated with PSMA-directed therapies.
●
Activity
following PSMA-directed therapy.
ATNM-400 retained anti-tumor activity after progression
on 177Lu-PSMA-617 and produced more durable tumor control and prolonged survival relative
to 177Lu-PSMA-617, supporting its potential use in patients who have exhausted PSMA-directed
radioligand therapy.
●
Activity
in ARPI-resistant disease.
ATNM-400 demonstrated greater tumor growth inhibition than
the approved ARPIs enzalutamide, apalutamide and darolutamide in ARPI-resistant models and
retained activity following progression on enzalutamide.
●
Enhanced
activity in combination with ARPIs.
Combinations of ATNM-400 with enzalutamide, apalutamide
or darolutamide produced enhanced tumor growth inhibition, tumor regression and durable complete
responses. These findings are supported by evidence that ARPI resistance increases ATNM-400
target expression, providing a mechanistic rationale for the observed combination activity.
We
believe these findings support the potential development of ATNM-400 as a monotherapy or in combination with ARPIs across a broad mCRPC
population, including patients with ARPI-resistant, PSMA-low or PSMA-negative disease, as well as patients with PSMA-high disease who
may benefit from a differentiated safety profile.
23
Supporting
Data in Metastatic Resistant Prostate Cancer Models
ATNM-400
Is Directed Against a Non-PSMA Target With the Potential to Treat More Patients Across Lines of Prostate Cancer Therapy
ATNM-400
Demonstrated Robust Tumor Growth Inhibition and was Superior to PSMA-Targeted Agents Across PSMA-High (C4-2), PSMA-Low (22Rv1) and PSMA-Negative
(DU145) Prostate Cancer Models
ATNM-400
had robust efficacy in prostate cancer xenograft mouse models with high, low and no PSMA and was superior to 177-Lu-PSMA-617 in all the
models and to 225Ac-PSMA-617 in the Low-PSMA model. ATNM-400 had comparable efficacy to 225Ac-PSMA-617 in the High-PSMA model. Given
that 30% mCRPC patients have low or no PSMA expression and up to 70% of patients do not respond to Pluvicto
®
and nearly
all patients progress on Pluvicto
®
in <12 months, our data in 177-Lu-PSMA-617, the active ingredient in Pluvicto
®
,
suggests that ATNM-400 has the potential to treat a broader population of mCRPC patients.
ATNM-400
retained anti-tumor activity in prostate cancer models after tumors had progressed on 177Lu-PSMA-617. Following tumor progression on
177Lu-PSMA-617, ATNM-400 produced continued tumor growth inhibition, supporting its potential to treat patients who have exhausted PSMA-directed
radioligand therapy.
24
ATNM-400
Demonstrated Robust Efficacy After 177Lu-PSMA-617 Failure in Prostate Cancer Model
Beyond
tumor growth inhibition, ATNM-400 conferred a survival benefit relative to PSMA-directed radioligand therapy. In preclinical prostate
cancer models, animals treated with ATNM-400 survived longer than those treated with 177Lu-PSMA-617, consistent with the greater and
more durable tumor control described above and achieved it at approximately one-thousandth of the administered radioactivity.
ATNM-400
Improved Survival vs 177Lu-PSMA-617 in Prostate Cancer Model
ATNM-400
demonstrated activity in prostate cancer cells and tumors resistant to all three approved
androgen-receptor pathway inhibitors (ARPIs) - enzalutamide, apalutamide, and darolutamide.
Across these studies, ATNM-400 delivered tumor control as either a single-bolus or repeat-dose
regimen with a consistent safety profile and minimal off-target toxicity, which we believe
indicates dosing flexibility and a wide therapeutic window.
25
In
an ARPI-resistant model, ATNM-400 as a monotherapy and in combination with enzalutamide produced greater tumor growth inhibition and
prolonged survival than enzalutamide alone that correlated well with overall survival. In the combination arm, 40% of the mice had complete
cures that were durable up to 100 days post- treatment. The latter can be explained by mechanistic synergy since it has been published
that enzalutamide resistance increases ATNM-400 target expression in prostate cancer models and in tumor biopsies from mCRPC patients.
ATNM-400
Monotherapy Demonstrated Superiority to Enzalutamide in ARPI-resistant Prostate Cancer Model and Had Complete Cures with Combination
Activity
ATNM-400
Showed Survival Benefit vs Enzalutamide
Monotherapy and Combination
26
Following
disease progression on enzalutamide, ATNM-400 produced continued tumor growth inhibition, supporting its potential to treat patients
who have exhausted ARPIs.
ATNM-400
Displayed Strong Efficacy After Enzalutamide Failure
In
data presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in June 2026, as a monotherapy in
the ARPI-resistant 22Rv1 model, ATNM-400 achieved 94% tumor growth inhibition, compared with 32% for apalutamide and 5% for darolutamide,
and in combination with either apalutamide or darolutamide achieved 107% tumor growth inhibition (representing tumor regression), with
durable complete responses in a majority of treated animals.
ATNM-400
Monotherapy Had Strong Tumor Growth Inhibition in the ARPI-Resistant 22Rv1 Prostate Cancer Model Resistant to Darolutamide and Apalutamide
ATNM-400
Combination with Darolutamide or Apalutamide Demonstrated Strong Tumor Growth Inhibition and Achieved Complete Responses (CRs) in the
ARPI-Resistant 22Rv1 Prostate Cancer Model
27
ATNM-400
in Non-Small Cell Lung Cancer (NSCLC)
ATNM-400
is being developed as a potential mutation-agnostic targeted radiotherapy for non-small cell
lung cancer (NSCLC). Its target is broadly expressed across NSCLC, including EGFR- and KRAS-mutant
disease, and is further increased following resistance to targeted therapies. Because ATNM-400
acts independently of a tumor’s driver mutation or signaling pathway, we believe it
has the potential to address a broad, target-defined NSCLC population.
Key
Findings and Therapeutic Positioning in Non-Small Cell Lung Cancer
●
Target-specific
activity across major NSCLC driver mutations.
ATNM-400 demonstrated target-specific binding,
internalization and tumor uptake across EGFR-mutant and multiple KRAS-mutant models, supporting
activity driven by target expression rather than by a particular driver mutation.
●
Greater
activity than therapies used across EGFR-mutant treatment settings.
In an EGFR-mutant
model, ATNM-400 demonstrated greater tumor growth inhibition than the active ingredient in
the key approved therapies used across first-, second- and third-line settings, including
osimertinib, amivantamab and datopotamab deruxtecan.
●
Enhanced
activity in combination with osimertinib.
Combining ATNM-400 with osimertinib produced
tumor regression and complete responses exceeding either agent alone. Osimertinib increased
ATNM-400 target expression, providing a mechanistic rationale for the observed combination
activity.
●
Monotherapy
and combination activity across KRAS-mutant disease.
ATNM-400 demonstrated activity in
both KRAS G12C- and KRAS G13D-mutant models, including greater activity than approved KRAS
G12C inhibitors and tumor regression in combination with sotorasib and adagrasib. Sotorasib
and adagrasib also increased ATNM-400 target expression, supporting the potential for combination
use.
We
believe these findings support the potential development of ATNM-400 as a monotherapy or combination backbone across EGFR- and KRAS-mutant
NSCLC and potentially the broader target-positive NSCLC population.
ATNM-400
vs Standard of Care Therapies Across EGFR- and KRAS-Mutant NSCLC Models
28
Supporting
Data in NSCLC
In
an EGFR-mutant model (NCI-H1975, harboring L858R and T790M mutations), ATNM-400 monotherapy achieved 75% tumor growth inhibition, compared
with 40% for osimertinib, and the combination of ATNM-400 plus osimertinib achieved 107% tumor growth inhibition (representing tumor
regression) with complete cures in 100% of treated animals.
ATNM-400
Monotherapy Showed Strong Tumor Growth Inhibition and Combination with Osimertinib Achieved Complete Responses in the EGFR-Mutant NSCLC
Model
Osimertinib
treatment increased ATNM-400 target expression both in vitro and in vivo, which we believe provides a mechanistic rationale for why the
combination of osimertinib with ATNM-400 works even better than ATNM-400 monotherapy alone. Furthermore, in vitro studies also demonstrated
that Osimertinib upregulated the ATNM-400 target in NCI-H1975 cells, enhancing ATNM-400 cytotoxicity when dosed in combination.
Increased
Target Expression
Post-Osimertinib Treatment
ATNM-400
Post-Osimertinib
29
In
the same EGFR-mutant model, ATNM-400 monotherapy also demonstrated greater anti-tumor activity than the approved agents datopotamab deruxtecan
(a TROP-2 antibody drug conjugate), amivantamab (an EGFR-cMET bispecific antibody), and izalontamab brengitecan (a HER3-EGFR bispecific
antibody-drug conjugate that is currently in development).
ATNM-400
Demonstrated 3-5x Greater Tumor Growth Inhibition vs Osimertinib or Dato-DXd or Amivantamab in EGFR-mutant NSCLC Model
ATNM-400
Demonstrated Superior Tumor Growth Inhibition Compared to Dato-DXd or Izalontamab Brengitecan in EGFR-mutant NSCLC Model
30
In
data presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in June 2026, ATNM-400 demonstrated
activity across KRAS-mutant NSCLC models spanning distinct KRAS alleles. In a KRAS G12C model (NCI-H358), ATNM-400 monotherapy achieved
92% tumor growth inhibition, compared with 0% for the approved KRAS G12C inhibitor sotorasib, and the combination of ATNM-400 plus sotorasib
achieved 90% tumor growth inhibition. In the same G12C model, the combination of ATNM-400 with adagrasib achieved 110% tumor growth inhibition
(indicating regression) compared to 71% for adagrasib alone.
ATNM-400
Showed Superior Efficacy versus Approved KRAS G12C Inhibitors in KRAS G12C-Mutant NSCLC Model
Treatment
with the approved KRAS G12C inhibitors sotorasib and adagrasib increased ATNM-400 target expression by up to approximately 3.5- and 3.8-fold,
respectively (p<0.0001). The addition of ATNM-400 reduced cancer-cell viability beyond KRAS G12C inhibitors alone - demonstrating
the same target-expression-increasing, synergy-enabling biology previously observed with the EGFR inhibitor osimertinib.
Sotorasib
and Adagrasib Increase ATNM-400 Target Expression in a Dose-Dependent Manner in the KRAS G12C-Mutant NCI-H358 NSCLC Model
31
Positron-emission-tomography
imaging of Zr-89-labeled ATNM-400 confirmed target-specific tumor uptake in a KRAS G12C model with low uptake in healthy normal tissues.
Zr-89-ATNM-400
PET Imaging Showed Tumor-specific Uptake that is Blocked by Unlabeled Cold Antibody Demonstrating Specificity in the KRAS G12C-Mutant
NSCLC Model
In
a target-positive KRAS G13D-mutant NSCLC model (Calu-3), single doses of 20 uCi/kg or 40
uCi/kg of ATNM-400 reduced tumor volume below baseline, corresponding to 124% and 135% tumor
growth inhibition which translates to tumor regression. The unlabeled antibody produced minimal
tumor growth inhibition relative to vehicle - indicating that anti-tumor activity is driven
by the Ac-225 payload rather than by antibody-mediated target engagement alone.
ATNM-400
Had Dose-Dependent Tumor Growth Inhibition in the KRAS G13D-Mutant NSCLC Model
32
ATNM-400
in Breast Cancer
ATNM-400’s
target antigen is overexpressed across breast cancer subtypes, including HR+/HER2-, HER2+ (including HR+ and HR-), and triple-negative
breast cancer, and is retained or increased following resistance to endocrine and HER2+-directed therapies. Because ATNM-400 acts through
a pathway-independent mechanism, we believe it has the potential to address multiple treatment-resistant breast cancer populations as
a monotherapy or in combination with existing standards of care. In addition, we do not believe ATNM-400 carries the risks of interstitial
lung disease (ILD) associated with ADCs carrying the deruxtecan payload.
Key
Findings and Therapeutic Positioning in Breast Cancer
●
Activity
in treatment-resistant HER2+ disease.
In a trastuzumab-resistant HER2+ model, ATNM-400 demonstrated strong monotherapy activity
and enhanced activity in combination with trastuzumab, with efficacy comparable to trastuzumab deruxtecan in the evaluated model.
Increased ATNM-400 target expression in HER2 resistant disease provides a mechanistic rationale for this activity.
●
Activity
in triple-negative breast cancer.
ATNM-400 monotherapy produced tumor regression in a
TNBC model, supporting its potential in a disease subtype with limited targeted treatment
options.
●
Activity
following HER2 directed therapy failure.
ATNM-400 retained durable anti-tumor activity after trastuzumab progression and demonstrated
greater activity than trastuzumab deruxtecan in the post-trastuzumab-failure setting without the risks of ILD associated with ADCs
addressing the indication.
●
Activity
in endocrine-resistant HR+ disease.
ATNM-400 demonstrated dose-dependent activity in
an endocrine-resistant HR+ model, supporting activity independent of HER2 status and endocrine
sensitivity.
●
Combination
activity in endocrine treatment-resistant disease.
Following
tamoxifen failure, sequential treatment with ATNM-400 drove a dose-dependent, near-complete
loss of cancer-cell viability, supporting ATNM-400's potential to deepen response after endocrine
therapy failure.
We
believe these findings support the potential development of ATNM-400 across breast cancer subtypes, with particularly differentiated
opportunities in TNBC and treatment-resistant HER2+ disease, as well as additional potential in endocrine-resistant HR+ disease.
Supporting
Data in Breast Cancer Models
In
a trastuzumab-resistant HER2+ model (BT474-Clone5), ATNM-400 monotherapy achieved 97% tumor growth inhibition and, in combination with
trastuzumab, achieved 100% tumor growth inhibition (representing tumor regression) - comparable to the approved HER2 antibody-drug conjugate
trastuzumab deruxtecan, without the higher risks of interstitial lung disease associated with ADC with the deruxtecan payload. ATNM-400
monotherapy drove tumor regression (103% tumor growth inhibition) in a triple-negative model (MDA-MB-468). Similar to referenced KRAS
G13D studies in NSCLC, unlabeled antibody produced minimal tumor growth inhibition relative to vehicle – again indicating that
anti-tumor activity is driven by ATNM-400’s Ac-225 payload versus antibody-mediated target engagement.
ATNM-400
Monotherapy and Combinations Eradicate Trastuzumab-Resistant Tumors and Triple-Negative Breast Cancer (TNBC)
Trastuzumab-Resistant
HER2+ Model BT474-Clone5
MDA-MB-468
(TNBC) Breast Cancer Model
In
the post-trastuzumab-failure setting, ATNM-400 retained durable anti-tumor activity (93%
tumor growth inhibition), exceeding trastuzumab deruxtecan (64%), further demonstrating utility
after resistance to approved drugs.
33
ATNM-400
Demonstrated Efficacy After Trastuzumab and HER2-DXd Failures in Trastuzumab-resistant Breast Cancer Model
ATNM-400
demonstrated dose-dependent activity in an endocrine-resistant HR+ model (MCF7), consistent with activity that is independent of HER2
status and endocrine sensitivity.
ATNM-400
Showed Dose-Dependent Tumor Growth Inhibition in MCF7 (HR+) Breast Cancer
In
an endocrine-resistant (HR+) setting modeling patients who have failed prior tamoxifen, ATNM-400, when given sequentially after tamoxifen
exposure, drove a tamoxifen dose-dependent, near-complete loss of cancer-cell viability - reducing viability to as low as approximately
3%.
ATNM-400
Significantly Decreased Cancer Cell Viability Post-Tamoxifen Failures
34
Actimab-A
for MDSCs: Novel Immunomodulatory Approach in Solid Tumors
Actimab-A
(lintuzumab-Ac-225) is a CD33-targeted actinium-225 radioconjugate that we are developing to enhance checkpoint inhibitor efficacy by
depleting immunosuppressive CD33+ myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment. MDSCs are a heterogeneous population
of immature myeloid cells that accumulate in solid tumors and suppress anti-tumor T-cell responses, representing a well-validated mechanism
of resistance to PD-1/PD-L1 checkpoint inhibitors. By selectively eliminating these suppressive cells with targeted alpha-particle therapy,
Actimab-A is designed to dismantle this barrier and restore an environment in which checkpoint blockade can drive meaningful Tcell–mediated
tumor killing. This positions Actimab-A as a differentiated immunomodulatory approach intended to expand the population of patients who
benefit from checkpoint inhibitors, including those with tumors historically considered immunologically “cold.”
Actimab-A
Depletion of MDSCs: Resensitizing PD-1 Inhibitors for T Cell Activation
35
Clinical
studies have demonstrated that patients with high circulating MDSC levels have significantly reduced progression-free and overall survival
on PD-1 therapy compared to patients with low MDSC levels.
Low
MDSCs Associated With Statistically Significant Improvement in PFS and OS
(Bronte
et al., Frontiers in Immunology 2022)
Our
preclinical studies have suggested that Actimab-A: (1) selectively homes to tumor-resident CD33+ MDSCs in vivo; (2) are cytotoxic to
patient-derived MDSCs ex vivo; and (3) rescue T-cell proliferation and anti-tumor immune responses ex vivo following MDSC depletion.
We believe these data provide mechanistic support for combining Actimab-A with PD-1 inhibitors to overcome MDSC-mediated resistance.
Actimab-A
(Lintuzumab-Ac225) was shown to deplete MDSCs in our studies. Actimab-A was also shown to restore T-cell proliferation in a dose dependent
manner
.
Actimab-A Depletes Human
MDSCs In Vivo
Actimab-A
Facilitates T cell Proliferation
36
We
intend to conduct a Phase 1b basket trial evaluating Actimab-A in combination with pembrolizumab (Keytruda
®
) or nivolumab
(Opdivo
®
) in patients with R/R locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC), NSCLC, glioblastoma
(GBM), and microsatellite instability (MSI)-high colorectal cancer. These tumor types were selected based on high MDSC infiltration and
limited response rates to PD-1 monotherapy. The trial design incorporates comprehensive correlative biomarker assessments to evaluate
MDSC depletion in both tumor microenvironment and peripheral blood, as well as T-cell activity restoration.
Patients
eligible to be enrolled in the trial must have MDSC-rich tumor types, be checkpoint inhibitor-naïve, be at least 18 years of age,
and demonstrate PD-1/PD-L1 expression. Primary endpoints include safety and tolerability of the combination, with secondary endpoints
including ORR, PFS, and OS. Biomarker endpoints will evaluate the pattern of CD33+ MDSC depletion and T-cell activity in both tumor tissue
and peripheral blood samples. Clinical outcomes will be compared against real-world data from similar patient populations treated with
PD-1 monotherapy. We expect to report initial data from this trial in 2H:2026 or 1H:2027. In addition, we are also evaluating clinical
opportunities with other immune checkpoint inhibitors in GBM and NSCLC.
Hematology
Programs
Actimab-A:
Backbone Therapy for AML and MDS
In
hematologic malignancies, we are developing Actimab-A as a mutation-agnostic backbone therapy for AML and high-risk MDS. CD33 is expressed
on leukemic blasts in the majority of AML patients and represents an established therapeutic target validated by the approval of gemtuzumab
ozogamicin (Mylotarg
®
). However, antibody-drug conjugates like Mylotarg
®
can have limitations, including
hepatotoxicity and limited efficacy in certain patient populations. Actimab-A, delivering the highly potent alpha-emitter Ac-225 to CD33+
cells, represents a differentiated approach designed to provide superior efficacy while maintaining a favorable safety profile. Supporting
this backbone positioning, preclinical and translational studies have demonstrated that Actimab-A is cytotoxic in primary AML patient
samples irrespective of FLT3, KMT2A, NPM1, IDH1, or TP53 mutation status. The combinations of Actimab-A with agents from each of the
three major classes of AML standard-of-care therapies, including the menin inhibitor revumenib, the FLT3 inhibitor gilteritinib, and
the hypomethylating agent azacitidine, potentiate AML cell death, supporting a backbone strategy. Actimab-A was shown to produce consistent
transcriptional reprogramming, including activation of p53-associated stress response and apoptosis pathways and downregulation of proliferative
programs such as MYC targets and G2/M checkpoint signatures.
We
have completed a Phase 1b clinical trial evaluating Actimab-A in combination with CLAG-M chemotherapy in R/R AML patients, results of
which were published in a peer-reviewed journal Leukemia in February 2025. The trial enrolled high-risk patients including those with
TP53 mutations, prior venetoclax treatment failure, and patients who had prior allogeneic transplant. Results demonstrated high rates
of measurable residual disease (MRD)-negative complete remissions and improved survival outcomes compared to historical controls.
Among
patients treated with Actimab-A plus CLAG-M, 70% of those deemed eligible for transplant proceeded to bone marrow transplant, and this
population achieved a 24-month median overall survival. These results compare favorably to published data showing less than 2-4 month
median overall survival in TP53-mutated or prior venetoclax-treated R/R AML patient populations. The combination was well-tolerated with
a safety profile consistent with CLAG-M chemotherapy alone and no dose-limiting toxicities observed.
We
have discussed with the Food and Drug Administration (FDA) and believe we are aligned on a Phase 2/3 trial design to evaluate Actimab-A
plus CLAG-M in R/R AML patients eligible for first or second salvage therapy. We are actively seeking a strategic partner to execute
this trial. We believe the trial design allows for enrollment of a broad R/R AML population while enriching for patients most likely
to benefit based on Phase 1b results.
37
Actimab-A
+ CLAG-M Phase 2/3 Trial Design
Actimab-A
Development Programs: Beyond R/R AML, we are developing Actimab-A in conjunction with the National Cancer Institute, or NCI across multiple
AML and MDS treatment settings and exploring its potential in additional areas:
●
Frontline
AML Triplet Combination: Evaluating Actimab-A as a backbone therapy in combination with standard induction regimen of venetoclax
and a hypomethylating agent in newly diagnosed AML patients. This mutation-agnostic approach could provide benefit across the broad
frontline AML population.
●
Combination
with Targeted Therapies: Developing Actimab-A combinations with FLT3 inhibitors, IDH1/2 inhibitors, and menin inhibitors in genomically-defined
AML patient subsets. These combinations leverage Actimab-A’s mutation-agnostic mechanism while potentially enhancing efficacy
through complementary mechanisms of action.
●
High-Risk
MDS Monotherapy: Evaluating Actimab-A as monotherapy in high-risk MDS patients who have failed hypomethylating agent therapy, representing
a patient population with very limited treatment options and poor outcomes.
●
Maintenance
Therapy: The potential exists for Actimab-A as maintenance therapy following achievement of remission to prevent relapse in AML and
MDS patients.
The
programs are supported by our Cooperative Research and Development Agreement (CRADA) with the NCI, which enables cost-effective clinical
development while retaining commercial rights to Actimab-A.
On
April 21, 2026, preclinical translational data with Actimab-A were presented at the AACR Annual Meeting in San Diego, California. The
presentation highlighted the following:
Transcriptional
Reprogramming as a Key Mechanism for Actimab-A Combination Activity
●
Combination
treatment produced consistent pathway-level changes compared with monotherapy, with gene set enrichment analysis (GSEA) showing enhanced
myeloid differentiation signatures when Actimab-A was added to revumenib, gilteritinib, and azacitidine, agents from each of the
three major classes of AML standard-of-care therapies.
●
Across
models, combinations were associated with downregulation of proliferative programs, including MYC target genes, E2F targets, and
G2/M checkpoint signatures, together with enrichment of p53-associated stress response and apoptosis pathways.
●
We believe
these findings indicate that Actimab-A combinations reprogram AML cells from proliferation toward differentiation and apoptosis,
potentially providing a mechanistic basis for deeper and more durable MRD-negative responses and supporting Actimab-A’s role
as a universal combination backbone across AML treatment settings.
38
Gene
Set Enrichment Analysis Demonstrated Broad Activity of Actimab-A Combinations Versus AML Standard of Care Therapies Alone
Combinations
with Revumenib and Azacitidine Sensitize AML Cells to Actimab-A and Support Frontline Triplet Rationale
39
●
Actimab-A
demonstrated robust cytotoxicity in primary AML patient samples independent of FLT3, KMT2A, NPM1, IDH1, IDH2, or TP53 mutation status,
supporting its potential applicability across the full AML patient population, including TP53-mutant patients who lack effective
targeted options.
●
Combining
Actimab-A with standard-of-care therapies, including revumenib (menin inhibitor), gilteritinib (FLT3 inhibitor), and azacitidine
(hypomethylating agent), enhanced anti-leukemic efficacy across models, demonstrating synergy with agents representing each of the
three pillars of modern AML care and, we believe, further support Actimab-A’s positioning as a combination partner across frontline,
relapsed/refractory, and unfit AML populations.
Actimab-A
Combination with SOC Enhance Cytotoxicity in Primary AML Patient Samples
40
Iomab-ACT:
Universal Conditioning for Cell and Gene Therapies
Iomab-ACT
is our CD45-targeted conditioning platform being developed as a universal conditioning agent to improve access and outcomes for cell
and gene therapies, including CAR-T, allogeneic hematopoietic stem cell transplant, and gene therapy. The cell and gene therapy field
has been limited by the need for lymphodepleting chemotherapy conditioning, which is associated with significant toxicities and can limit
the patient populations eligible for these potentially curative treatments.
Iomab-ACT
is designed to provide targeted lymphodepletion and myeloablation when necessary while avoiding the off-target toxicities associated
with chemotherapy conditioning. By delivering targeted radiation specifically to CD45+ hematopoietic cells, Iomab-ACT aims to create
an optimal environment for therapeutic cell engraftment while minimizing treatment-related morbidity and mortality.
We
currently have three active clinical trials evaluating Iomab-ACT:
●
Phase
1/2 Trial in Commercial CAR-T: Evaluating Iomab-ACT as conditioning prior to commercial CAR-T therapy in patients with relapsed/refractory
non-Hodgkin’s lymphoma. The primary endpoint is engraftment and key secondary endpoints are incidence of Cytokine Release Syndrome
(CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which are two potentially fatal adverse events associated
with CAR-T cell therapy.
●
Phase
1 Trial in experimental CAR-T: Evaluating Iomab-ACT as conditioning prior to CD19 CAR-T cell therapy in patients with relapsed /refractory
B-cell malignancies.
●
Phase
1 Trial in Sickle Cell Disease BMT: Evaluating Iomab-ACT as conditioning for allogeneic bone marrow transplant in patients with sickle
cell disease.
Iomab-B:
Targeted Conditioning for Bone Marrow Transplant in R/R AML
Iomab-B
(apamistamab-I-131) is a CD45-targeted radioimmunotherapy designed to enable bone marrow transplant in R/R AML patients who are ineligible
for conventional myeloablative conditioning due to age, comorbidities, or prior treatment-related toxicities. CD45 is expressed on all
hematopoietic cells, enabling Iomab-B to deliver targeted radiation to bone marrow while sparing non-hematopoietic organs from radiation
exposure.
Conventional
stem cell transplant conditioning regimens utilize high-dose chemotherapy, with or without total body irradiation, to ablate the patient’s
hematopoietic system and create space for donor cell engraftment. These regimens are associated with significant toxicities including
mucositis, hepatotoxicity, pulmonary toxicity, and treatment-related mortality. Many elderly patients and those with comorbidities are
deemed ineligible for these intensive conditioning regimens, limiting access to potentially curative transplant therapy.
Iomab-B
has been evaluated in over 500 patients across multiple clinical trials, including the Phase 3 SIERRA trial in R/R AML patients. The
SIERRA trial demonstrated that Iomab-B enabled successful donor cell engraftment in elderly R/R AML patients who would otherwise be ineligible
for conventional conditioning. The study met the primary endpoint of durable complete remission (dCR). While the study did not meet the
secondary endpoint of OS due to the cross-over of two-thirds of the patients from the control arm to the Iomab-B arm, it provided important
insights into optimal patient selection and trial design for future development.
We
have discussed our Phase 2/3 trial design with FDA and, based on the feedback, we believe we are aligned on a Phase 2/3 trial design
in an expanded R/R AML patient population that includes all patients age 18 and older with R/R AML. This expanded population reflects
learnings from SIERRA regarding optimal patient selection. We believe the trial design allows us to leverage both the Phase 2 results
and the SIERRA database to support regulatory submissions.
Iomab-B
benefits from composition of matter patents extending to 2038, a well-established network of 24 clinical sites from the SIERRA trial
that maintains strong interest in the program, and potential for market expansion beyond R/R AML. Preclinical and clinical data support
potential development in five additional disease indications including acute lymphoblastic leukemia, myelodysplastic syndromes, chronic
myeloid leukemia, multiple myeloma, and lymphoma, representing a total addressable market of approximately 150,000 patients who could
benefit from improved bone marrow transplant conditioning.
We
are actively seeking a strategic partner to advance Iomab-B through pivotal development and commercialization.
41
Our
Platform and Capabilities
Radiochemistry
and Translational Science Capabilities
We
have assembled a team with expertise in radiopharmaceutical discovery and development, spanning target selection, radioconjugate design,
preclinical evaluation, and clinical development. Our capabilities include:
●
Target
Selection and Validation: Comprehensive target assessment including expression profiling in tumor versus normal, binding and internalization
kinetics, and competitive landscape analysis to identify optimal targets for radiopharmaceutical development.
●
Radioconjugate
Design and Optimization: Medicinal chemistry expertise in chelator selection, linker design, and conjugation chemistry to optimize
tumor uptake, retention, and biodistribution while minimizing normal organ exposure.
●
Preclinical
Pharmacology: In vitro and in vivo models to assess binding affinity, internalization, tumor penetration, radiation dosimetry, and
anti-tumor efficacy across diverse tumor types.
●
Translational
Biomarkers: Development of imaging companion diagnostics, circulating biomarkers, and tissue-based assessments to enable patient
selection and monitor treatment response.
We
believe these capabilities enable us to efficiently advance programs from target selection through clinical development while maintaining
high quality standards and generating comprehensive translational data packages to guide clinical development and support regulatory
submissions and partnership discussions.
Clinical
Development Operations
We
conduct company-sponsored clinical development activities through a combination of internal personnel and third-party service providers
in the United States and selected international jurisdictions where we operate through subsidiaries and/or contract research organizations.
Our clinical development capabilities include clinical trial planning and execution, regulatory affairs, clinical monitoring, pharmacovigilance,
medical oversight, data management, biostatistics and investigational product logistics. We work with contract research organizations,
clinical investigators, central laboratories and other specialized vendors to support patient enrollment, study execution and regulatory
compliance across our development programs.
We
believe this operating model provides flexibility to efficiently advance multiple clinical programs while maintaining quality oversight,
operational scalability and regulatory compliance. We expect to report data from ongoing company- and investigator-sponsored clinical
studies for ATNM-400, Actimab-A for MDSC’s and Iomab-ACT in 4Q:2026 and over the course of 2027.
Ac-225
Production and Radiopharmaceutical Manufacturing
We
have developed proprietary cyclotron-based technology for commercial-scale production of Ac-225, one of the most critical bottlenecks
in radiopharmaceutical development. Our production method generates high-purity Ac-225 with radiochemical purity equivalent to the gold-standard
thorium-229 decay method, while avoiding the generation of long-lived radioactive contaminants such as Ac-227. This production technology
is protected by patents and if operationalized may represent a significant competitive and cost advantage.
We
are currently completing construction of a radiopharmaceutical manufacturing facility designed to manufacture Ac-225-based final drug
products for clinical supply. The facility, expected to be operational in 2H:2026, incorporates purpose-built infrastructure for alpha-emitter
handling and a flexible manufacturing suite capable of supporting multiple trials.
We
have also established an end-to-end supply chain spanning isotope production through patient administration. Our clinical development
infrastructure supports company-sponsored clinical development activities conducted in the United States and selected international jurisdictions
through relationships with isotope suppliers, contract development and manufacturing organizations and specialized radiopharmaceutical
logistics providers. We maintain supply agreements with multiple redundant isotope suppliers, relationships with multiple contract manufacturing
organizations, and a distribution network to approximately 50 leading cancer centers amassed via the execution of several Phase 1 –
3 clinical trials. This supply chain infrastructure provides geographic coverage across major metropolitan areas, minimizes risk of supply
disruption, and positions us to reliably serve patient demand at clinical scale.
42
Intellectual
Property
We
strive to protect and enhance the proprietary technologies that we believe are important to our business, including seeking, maintaining
and defending patent rights, whether developed internally or licensed from third parties. Our policy is to seek to protect our proprietary
position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements
that are important for the development and implementation of our business. We also rely on trade secrets, know-how, continuing technological
innovation and in-licensing opportunities to develop, strengthen and maintain our proprietary position. Our intellectual property portfolio
comprises approximately 250 patents and patent applications across multiple jurisdictions. Our patent estate includes:
●
Composition
of Matter Patents: Covering our key product candidates including Iomab-B, Iomab-ACT, and ATNM-400.
●
Method
of Use Patents: Covering specific therapeutic applications, combination therapies, and treatment protocols for our product candidates
Actimab-A, Iomab-B, Iomab-ACT, and ATNM-400, as well as preclinical pipeline candidates.
●
Manufacturing
and Process Patents: Protecting our cyclotron-based Ac-225 production technology, radiopharmaceutical manufacturing processes, and
formulation technologies.
●
Platform
Technology Patents: Protecting core technologies applicable across multiple programs including chelator chemistry, targeting approaches,
and bioconjugation methods.
Our
patents provide market exclusivity in major territories including the United States, Europe, Canada, Japan, and key emerging markets.
We actively monitor and enforce our intellectual property rights and investigate potential infringement of our proprietary technologies.
In addition to patents, we maintain proprietary know-how and trade secrets relating to our radiopharmaceutical development platform,
manufacturing processes, and clinical development strategies. We seek to protect this information through confidentiality agreements
with employees, consultants, advisors, and collaborative partners. We also rely on regulatory exclusivity to protect our products from
competition. In the United States, biologics such as our antibody radioconjugates may be eligible for 12 years of market exclusivity
under the Biologics Price Competition and Innovation Act. If any of our product candidates are approved for orphan indications, we may
be eligible for seven years of market exclusivity in the United States, and similar exclusivity periods in other territories.
Manufacturing
and Supply Chain
Our
manufacturing strategy combines internal capabilities with external partnerships to create a flexible, redundant, and cost-effective
supply chain capable of supporting both clinical development and commercial supply. This hybrid approach provides us with strategic flexibility,
supply reliability, and the ability to scale production to meet patient demand.
Internal
Manufacturing Capabilities
We
are completing construction of a state-of-the-art cGMP radiopharmaceutical manufacturing facility located in New York, expected to be
operational in 2H:2026. This facility has been purpose-built for alpha-emitter handling and radiopharmaceutical production with the following
capabilities:
●
Therapeutic
Drug Product Manufacturing: production suites for radioconjugate synthesis, formulation, fill-finish, and quality control testing,
designed to support multiple simultaneous programs.
●
Quality
Control and Analytics: Comprehensive analytical capabilities including radiochemical purity testing, stability assessment, sterility
testing, and release testing in accordance with regulatory requirements.
●
Radiation
Safety Infrastructure: Shielded manufacturing suites and a comprehensive radiation safety program to protect personnel and environment.
43
External
Manufacturing Partnerships
We
have established partnerships with multiple contract manufacturing organizations providing geographic redundancy and production flexibility
to support company-sponsored clinical development activities in the United States and selected international jurisdictions. These partnerships,
together with relationships with specialized isotope suppliers and radiopharmaceutical logistics providers, support investigational product
manufacturing, distribution and clinical supply while providing operational redundancy and continuity of supply as the Company expands
its internal manufacturing capabilities:
●
Isotope
Supply: We maintain supply agreements with multiple domestic and international suppliers of Ac-225 and other radioisotopes, providing
priority access and redundancy to ensure reliable supply.
●
Contract
Manufacturing: We have qualified multiple contract manufacturers capable of producing our drug products under cGMP conditions. These
partnerships provide backup capacity, geographic diversity, and specialized capabilities complementing our internal manufacturing.
●
Distribution
Partners: We have established relationships with specialized radiopharmaceutical logistics providers capable of cold-chain distribution,
real-time tracking, and just-in-time delivery to clinical sites and commercial administration centers.
Supply
Chain Management
Our
supply chain team has established systems and processes to coordinate the complex logistics of radiopharmaceutical production and distribution:
●
Demand
Forecasting: Predictive models incorporating clinical trial enrollment, commercial demand projections, and inventory optimization
to ensure adequate supply while minimizing waste.
●
Production
Scheduling: Coordinated scheduling across isotope production, drug product manufacturing, quality testing, and distribution to optimize
efficiency and minimize decay losses.
●
Real-Time
Tracking: Systems to monitor location, temperature, and radiation levels throughout the supply chain from production through patient
administration.
●
Regulatory
Compliance: Procedures ensuring compliance with FDA, NRC, Department of Transportation, and international regulations governing radioactive
material handling, transportation, and administration.
Our
manufacturing and supply chain capabilities position us to support ongoing clinical development activities conducted in multiple jurisdictions
and future commercial operations while maintaining flexibility to respond to changing demand.
44
Human
Capital
As
of August 6, 2026, we had 27 full-time employees, 13 of whom have Ph.D. or M.D. degrees and 23 of whom are engaged in research and development
and clinical development activities. We believe that we have been successful to date in attracting skilled and experienced personnel
despite the competitive hiring environment in the industry. Our employees are not covered by a collective bargaining agreement, and we
believe that our relationship with our employees is excellent. We continue to engage external consultants on an as-needed basis to supplement
existing staff.
Results
of Operations - Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025
The
following table sets forth, for the periods indicated, data derived from our statements of operations:
For the
Three Months Ended
June 30
(in thousands)
2026
2025
Revenue:
Revenue
$
-
$
-
Other
revenue
35,000
-
Total
revenue
35,000
-
Operating expenses:
Research and development,
net of reimbursements
5,377
4,879
General
and administrative
2,058
2,624
Total
operating expenses
7,435
7,503
Other income:
Interest
income – net
336
625
Total
other income
336
625
Income/(loss) before income taxes
27,901
(6,878
)
Income tax expense
-
-
Net income/(loss)
$
27,901
$
(6,878
)
45
Revenue
We
recorded no commercial revenue for the three months ended June 30, 2026 and June 30, 2025, respectively.
Other
revenue
On
April 7, 2022, we entered into a License Agreement with Immedica, pursuant to which Immedica licensed the exclusive product rights for
commercialization of Iomab-B in certain countries in the EUMENA region. Upon signing, we were entitled to an upfront, non-refundable
payment of $35 million from Immedica, which was received in May 2022. Under the terms of the License Agreement, we are eligible to receive
certain regulatory and commercial milestone payments and royalties on net sales of the product in certain countries that may result from
the License Agreement. We continue to retain commercialization rights in the U.S. and the rest of the world. The $35 million upfront
payment was initially recorded as Long-term license revenue - deferred due to uncertainty regarding Immedica’s ability to obtain
regulatory approval of the product by the European Medicines Agency. Subsequently, Immedica notified us that it would not pursue regulatory
approval of Iomab-B in the licensed territories. In the current period, based on the facts and circumstances, we concluded that Immedica’s
right to asserting a claim related to the $35 million had expired. Accordingly, the condition previously constraining recognition of
the $35 million upfront payment no longer existed and that the non-refundable payment was no longer subject to a significant reversal.
Therefore, we recognized the previously deferred $35 million upfront payment as revenue in June 2026.
Research
and development expense, net of reimbursements
Research
and development expenses include costs associated with preclinical and clinical development activities conducted in the United States
and selected international jurisdictions, including clinical site costs, contract research organizations, manufacturing, isotope supply,
investigational product logistics, regulatory support and pharmacovigilance. Certain international clinical development activities are
conducted through the Company’s wholly owned Australian subsidiary, Actinium Pharmaceuticals Australia Pty Ltd. The Company has
applied for available Australian research and development tax incentives associated with qualifying research activities.
Research
and development expenses, net of reimbursements, of $5.4 million for the three months ended June 30, 2026 increased by $0.5 million from
$4.9 million for the three months ended June 30, 2025, primarily due to increased preclinical expenses of $0.3 million, increased Chemistry,
manufacturing and controls, or CMC, expenses and clinical expenses of $0.6 million, partially offset by lower compensation expense of
$0.4 million due to lower headcount. In the second quarter of 2025, we conducted a workforce optimization that reduced our headcount
by approximately fourteen percent and announced a strategic pipeline prioritization which resulted in additional departures in 2025.
General
and administrative expense
General
and administrative expense of $2.1 million for the three months ended June 30, 2026 decreased by $0.5 million from $2.6 million for the
three months ended June 30, 2025 primarily due to a decrease in compensation expense of $0.4 million due to lower headcount and a decrease
in non-cash stock-based compensation expense of $0.1 million.
Other
income
Other
income is comprised of net interest income in both reporting periods. The amount for the three months ended June 30, 2026 of $0.3 million
decreased from $0.6 million for the three months ended June 30, 2025 primarily due to a lower average cash balance during the three months
ended June 30, 2026 compared to the prior-year period.
Income
tax expense
Income
tax expense was $0 for the three months ended June 30, 2026 and 2025. Despite reporting profit before income taxes of $27.9 million for
the three months ended June 30, 2026, no income tax expense was recorded as we have sufficient net operating losses that are available
to offset net taxable income. The Company’s estimated annual effective income tax rate is 0%, compared to the U.S. federal statutory
rate of 21%. The difference is attributable to the full valuation allowance maintained against the Company’s net deferred tax assets.
Based on the Company’s history of cumulative losses and the uncertainty of generating sufficient future taxable income to utilize
its deferred tax assets, management has determined that it is more likely than not that the net deferred tax assets will not be realized.
46
Net income
/ (loss)
Net
income of $27.9 million for the three months ended June 30, 2026 increased by $34.8 million from a net loss of $6.9 million for the three
months ended June 30, 2025 driven by the recognition of $35.0 million of revenue previously deferred in connection with the commercialization
agreement with Immedica.
Results
of Operations – Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
The
following table sets forth, for the periods indicated, data derived from our statements of operations:
For the
Six Months Ended
June 30,
(in thousands)
2026
2025
Revenue:
Revenue
$
-
$
-
Other
revenue
35,000
-
Total
revenue
35,000
-
Operating expenses:
Research and development,
net of reimbursements
9,578
12,579
General
and administrative
3,760
11,562
Total
operating expenses
13,338
24,141
Other income:
Interest
income – net
717
1,325
Total
other income
717
1,325
Income/(loss) before income taxes
22,379
(22,816
)
Income tax expense
-
-
Net income/(loss)
$
22,379
$
(22,816
)
Revenue
We
recorded no commercial revenue for the six months ended June 30, 2026 and June 30, 2025, respectively.
Other
revenue
As
noted above, we recognized $35 million as revenue in the six months ended June 30, 2026 related to the Immedica collaboration.
Stock-based
compensation expense
On
March 31, 2025, our Board of Directors approved the cancellation of certain stock options to purchase an aggregate of 4.9 million shares
of common stock held by certain current employees and directors that were initially granted under our Amended and Restated 2013 Stock
Plan and our 2019 Stock Plan. The cancellation of these stock options resulted in the recording of $8.7 million in non-cash stock compensation
expense for the six months ended June 30, 2025, $2.1 million in Research and development expense and $6.6 million in General and administrative
expense.
47
Research
and development expense, net of reimbursements
Research
and development expenses, net of reimbursements, of $9.6 million for the six months ended June 30, 2026 decreased by $3.0 million from
$12.6 million for the six months ended June 30, 2025. The cancellation of stock options in March 2025 described above resulted in lower
non-cash stock-based compensation expense of $2.1 million for the six months ended June 30, 2026 compared with the six months ended June
30, 2025. In addition, there was lower compensation cost of $0.9 million due to lower headcount.
General
and administrative expense
General
and administrative expense of $3.8 million for the six months ended June 30, 2026 decreased by $7.8 million from $11.6 million for the
six months ended June 30, 2025. Lower non-cash stock-based compensation expense of $6.9 million for the six months ended June 30, 2026
compared with the same period in 2025 was primarily driven by the cancellation of stock options in March 2025, discussed above. In addition,
in comparison to the prior-year period, compensation expense decreased $0.9 million due to lower headcount.
Other
income
Other
income is comprised of net interest income in both reporting periods. The amount for the six months ended June 30, 2026 of $0.7 million
decreased from $1.3 million for the six months ended June 30, 2025 primarily due to a lower average cash balance during the six months
ended June 30, 2026 compared to the prior-year period.
Income
tax expense
Income
tax expense was $0 for the six months ended June 30, 2026 and 2025. Despite reporting income before income taxes of $22.4 million for
the six months ended June 30, 2026, no income tax expense was recorded. The Company’s estimated annual effective income tax rate
is 0%, compared to the U.S. federal statutory rate of 21%.
Net income/(loss)
Net
income of $22.4 million for the six months ended June 30, 2026 increased by $45.2 million from a net loss of $22.8 million for the six
months ended June 30, 2025, driven by the recognition of $35.0 million of revenue previously deferred in connection with the commercialization
agreement with Immedica, lower stock-based compensation of $9.0 million discussed above and lower compensation expense of $1.8 million
due to lower headcount, slightly offset by lower other income of $0.6 million.
Liquidity
and Capital Resources
The
following table sets forth selected cash flow information for the periods indicated:
For the
Six Months Ended
June 30,
(in thousands)
2026
2025
Cash used in operating activities
$
(11,049
)
$
(12,966
)
Cash used in investing activities
(480
)
-
Cash used in financing activities
(5
)
(5
)
Effect of foreign currency
rates on cash
13
-
Net change in cash,
cash equivalents and restricted cash
$
(11,521
)
$
(12,971
)
48
Net
cash used in operating activities for the six months ended June 30, 2026 was $11.0 million, a decrease of $2.0 million from $13.0 million
in the prior-year period, primarily resulting from lower compensation expense as a result of lower headcount for the six months ended
June 30, 2026 compared to the prior-year period.
Cash
used in investing activities for the six months ended June 30, 2026 was $0.5 million related to the construction of modular removable
manufacturing improvements within our leased manufacturing facility. There was no cash used in investing activities for the six months
ended June 30, 2025.
Cash
used in financing activities for the six months ended June 30, 2026 and June 30, 2025 was $5 thousand and $5 thousand, respectively.
In
August 2020, we entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading,
pursuant to which we are able to sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common
stock. On June 28, 2022, we entered into an Amended and Restated Capital on Demand™ Sales Agreement, or the A&R Sales Agreement,
with JonesTrading and B. Riley Securities, Inc. (“B. Riley”). The A&R Sales Agreement modifies the original Capital on
Demand™ Sales Agreement to include B. Riley as an additional sales agent thereunder. Shares of common stock were offered pursuant
to a shelf registration statement on Form S-3 (File No. 333-242322) filed with the SEC on August 7, 2020 (the “Prior Shelf Registration
Statement”). On August 11, 2023, we filed a registration statement on Form S-3 (File No. 333-273911), which was amended on February
2, 2024, and declared effective on February 5, 2024, to replace the Prior Shelf Registration Statement, including a base prospectus which
covers the offering, issuance and sale of up to $500 million of common stock, preferred stock, warrants, units and/or subscription rights;
and a sales agreement prospectus covering the offering, issuance and sale of up to a maximum aggregate offering price of $200 million
of common stock that may be issued and sold under the A&R Sales Agreement. There was no sale of shares of common stock during the
six months ended June 30, 2026 and 2025, respectively.
As
of the date of filing this report, we expect that our existing resources will be sufficient to fund our planned operations for more than
12 months following the date of this report.
Notice
of Delisting or Failure to Satisfy a Continued Listing Rule or Standard
On
May 27, 2026, the Company received a notice from NYSE American LLC indicating that we are not in compliance with the continued listing
standards set forth in Section 1003(a)(ii) of the NYSE American Company Guide, which requires a listed company to maintain stockholders’
equity of $4.0 million or more if it has reported losses from continuing operations and/or net losses in three of its four most recent
fiscal years. As of March 31, 2026, the Company reported stockholders’ equity of $2.3 million and had net losses in its last five
fiscal years ended December 31, 2025. As of June 30, 2026, the Company reported stockholders’ equity of $30.3 million.
In
connection with its non-compliance with Sections 1003(a)(ii) and (iii) of the Company Guide, the Company was required to submit a plan
by June 26, 2026, advising of actions it has taken or will take to regain compliance with the continued listing standards by November
27, 2027, or the Plan Period Deadline. If NYSE Regulation determines to accept the plan, we will be notified in writing and will be subject
to periodic reviews including quarterly monitoring for compliance with the plan. Note that typically, NYSE considers a company compliant
if it meets the listing requirements for two consecutive quarters. Subsequent to filing of this current Form 10-Q, we expect to be in
technical compliance based on our stockholder equity and expect to remain so thereafter.
On
June 18, 2026, we submitted our compliance plan to NYSE American, outlining certain actions management intends to take in effort to restore
compliance with applicable listing standards. If the plan is not accepted, delisting proceedings will commence. Furthermore, if the plan
is accepted but the Company is not in compliance with the continued listing standards by the Plan Period Deadline, or if the Company
does not make progress consistent with the plan during the plan period, NYSE American staff will initiate delisting proceedings as appropriate.
The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide.
The
Notice has no immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on NYSE American
under the symbol “ATNM,” subject to the Company’s compliance with the other continued listing requirements of NYSE
American, and will continue to trade with a “.BC” indicator to denote that the Company is below compliance.
49
There
can be no assurance that the Company will be able to regain or maintain compliance with the applicable continued listing standards, that
NYSE American will accept the Company’s Plan, that the Company will be able to comply with the terms of any accepted Plan, or that
the Company will be able to maintain the listing of its common stock on NYSE American.
Critical
Accounting Estimates
Our
management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation
of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and
expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements during the reporting periods.
These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur
in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe
are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and
liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in
which they become known. Actual results may differ materially from these estimates under different assumptions or conditions. The Company
does not have any critical accounting estimates.
Recently
Issued Accounting Pronouncements
In
September 2025, the FASB issued ASU 2025-07,
Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic
606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract
,
which excludes from derivative accounting non-exchange-traded contracts with underlying terms that are based on operations or activities
specific to one of the parties to the contract. However, this scope exception does not apply to (1) variables based on a market rate,
market price, or market index, (2) variables based on the price or performance of a financial asset or financial liability of one of
the parties to the contract, (3) contracts (or features) involving the issuer’s own equity that are evaluated under the guidance
in Subtopic 815-40,
Derivatives and Hedging—Contracts in Entity’s Own Equity,
and (4) call options and put options
on debt instruments. We can apply the amendments in AUS 2025-07 either (1) prospectively to new contracts entered into on or after the
date of adoption or (2) on a modified retrospective basis through a cumulative-effect adjustment to the opening balance of retained earnings
as of the beginning of the annual reporting period of adoption for contracts existing as of the beginning of the annual reporting period
of adoption. The amendments in ASU 2025-07 are effective January 1, 2027, for annual reporting periods, including interim periods within
annual reporting periods. Early adoption is permitted. We are evaluating the impact of ASU 2025-07 on our financial statements.
In
May 2025, FASB issued ASU 2025-04,
Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic
606): Clarifications to Share-Based Consideration Payable to a Customer
, which revises the Master Glossary definition of the term
“performance condition” for share-based consideration payable to a customer to include conditions, such as vesting conditions,
that are based on the volume or monetary amount of a customer’s purchases or potential purchases of goods or services from the
grantor, including over a specified period of time. The revised definition also incorporates performance targets based on purchases made
by other parties that purchase the grantor’s goods or services from the grantor’s customers. The revised definition of the
term performance condition cannot be applied by analogy to awards granted to employees and non-employees in exchange for goods or services
to be used or consumed in the grantor’s own operations. ASU 2025-04 eliminates the policy election permitting a grantor to account
for forfeitures as they occur for share-based awards granted to a customer. Separate policy elections for forfeitures remain available
for share-based payment awards with service conditions granted to employees and non-employees in exchange for goods or services to be
used or consumed in the grantor’s own operations. ASU 2025-04 further clarifies that a grantor should not apply the guidance in
Topic 606 on constraining estimates of variable consideration to share-based consideration payable to a customer. ASU 2025-04 permits
a grantor to apply the new guidance on either a modified retrospective or a retrospective basis. The amendments in ASU 2025-04 are effective
January 1, 2027, for annual reporting periods, including interim periods within annual reporting periods. We are evaluating the impact
of ASU 2025-04 on our financial statements.
50
In
November 2024, FASB issued ASU 2024-03,
Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures
(Subtopic
220-40), to improve the disaggregation of expenses within the consolidated statement of operations. The amendments in ASU 2024-03 require
disclosures in the notes to the consolidated financial statements and specified information about certain costs and expenses. The amendments
require that at each interim and annual reporting period an entity disclose (a) employee compensation, (b) depreciation, and (c) intangible
asset amortization included in each relevant expense caption; include certain amounts that are already required to be disclosed under
current GAAP in the same disclosure as the other disaggregation requirements; and disclose a qualitative description of the amounts remaining
in relevant expense captions that are not separately disaggregated quantitatively. The amendments in ASU 2024-03 are effective January
1, 2027 and effective for interim periods beginning January 1, 2028, either on a prospective or retrospective basis. We are evaluating
the impact of ASU 2024-03 on our financial statements.
In
December 2025, the FASB issued ASU 2025-11,
Interim Reporting
(Topic 270): Narrow-Scope Improvements. This update clarifies interim
disclosure requirements and centralizes such requirements within Topic 270. Among other changes, ASU 2025-11 introduces a disclosure
principle requiring entities to provide information about significant events or changes since the end of the last annual reporting period
that have a material impact, clarifies when duplicative annual disclosures may be omitted from interim reports, and aligns interim reporting
requirements with applicable SEC guidance for registrants. This guidance is effective for interim reporting periods within annual reporting
periods beginning after December 15, 2027. Early adoption is permitted. The amendments in ASU 2025-11 should be applied prospectively.
We are currently assessing the impact on its condensed consolidated financial statements and disclosures.
Known
Trends, Events and Uncertainties
The
Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks
associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development
by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with
government regulations and the ability to secure additional capital to fund operations. In addition, the consequences of the ongoing
geopolitical conflicts, such as the ongoing conflict between Russia and Ukraine and the ongoing conflicts in the Middle East, including
related sanctions and countermeasures, and the effects of rising global inflation, are difficult to predict, and could adversely impact
geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely
affect our business and operations. In the past, U.S. federal government shutdowns, such as the shutdown that began on October 1, 2025
and ended on November 12, 2025, have curtailed operations of key agencies such as the FDA and the NIH, which includes the NCI. Future
shutdowns may result in delays or disrupt our ability to advance clinical development of the current and planned clinical trials under
our CRADA, obtain regulatory interactions/approvals, or secure government-funded grants. Additionally, changes to U.S. policy implemented
by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things,
the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory
environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely
affect our business. For a further discussion of factors that may affect future operating results see the sections entitled “Risk
Factors” and “Cautionary Statement Regarding Forward-Looking Statement Notice.”
Other
than as discussed above and elsewhere in this report, we are not aware of any trends, events or uncertainties that are likely to have
a material effect on our financial condition.
51
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required
under this item.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
. Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we conducted an evaluation of the effectiveness, as of June 30, 2026, of our disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange
Act. Based upon such evaluation, our principal executive officer and principal financial officer have concluded that, as of June 30,
2026, our disclosure controls and procedures were effective to provide reasonable assurance that the information we are required to disclose
in our filings with the Securities and Exchange Commission, or SEC, under the Exchange Act (i) is recorded, processed, summarized and
reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management,
including our principal executive officer and principal financial and accounting officer, as appropriate to allow timely decisions regarding
required disclosure.
Changes
in Internal Control over Financial Reporting
. There were no changes in our internal controls over financial reporting during the
period covered by this Quarterly Report on Form 10-Q that has materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
52
PART
II – OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
From
time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation
is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
On
March 27, 2025, a putative class action complaint (the “Securities Complaint”) was filed by alleged stockholder Nitin Kohil
against the Company and executives Sandesh Seth, Avinash Desai, Madhuri Vusirikala, and Sergio Giralt (the “Defendants”),
styled
Kohil v. Actinium Pharmaceuticals, Inc., et al
., Case No. 1:25-cv-02553 in the United States District Court for the
Southern District of New York, (the “Court”). The Securities Complaint alleges that the Defendants made material misrepresentations
and omissions concerning the Iomab-B Phase 3 SIERRA Trial during a proposed class period of October 31, 2022 to August 2, 2024 and asserts
claims under Sections 10(b) and 20(a) of the Exchange Act. Plaintiff sought unspecified damages. On June 24, 2025, the court in the securities
action appointed lead plaintiffs (the “Lead Plaintiffs”) pursuant to the Private Securities Litigation Reform Act of 1995
and re-captioned the case as
In re Actinium Pharmaceuticals, Inc. Securities Litigation
. Lead Plaintiffs filed an amended complaint
on August 25, 2025. On October 27, 2025, Defendants moved to dismiss the amended complaint; on December 19, 2025, Lead Plaintiffs filed
their opposition; and on February 2, 2026, Defendants filed their reply in support. The parties are currently awaiting the Court’s
decision on Defendants’ motion.
On
May 5, 2025, a shareholder complaint captioned
Georges v. Seth et al.
, Case No. 1:25-cv-03738-JPO was filed against certain of
the Company’s directors and officers, alleging derivative liability based on the same factual allegations made in the securities
class action. On May 13, 2025, a second substantially identical derivative complaint captioned
Robinson v. Seth et al
., Case No.
1:25-cv-04012-JPO was filed. On June 24, 2025, the Court consolidated the derivative cases and, on July 29, 2025, the parties to the
derivative cases filed a stipulation with the Court to stay those matters pending resolution of the motion that defendants will file
in the securities class action. The Court so-ordered that stipulation on July 30, 2025, and re-captioned the case as
In re Actinium
Pharmaceuticals, Inc. Derivative Litigation.
On
June 17, 2025, a purported shareholder served Actinium with a demand for books and records pursuant to Section 220 of the Delaware General
Corporation Law. In general, the demand seeks documents relating to the facts at issue in the above-described securities class action
and derivative cases. The Company rejected the shareholder demand by letter dated July 8, 2025. The parties continue to discuss the demand.
The shareholder has not followed up on his demand since October 2025.
The
Company and other Defendants intend to defend vigorously against such claims, however, there can be no assurances as to the outcome.
ITEM
1A. RISK FACTORS
In
analyzing our company, you should consider carefully the following risk factors, together with all of the other information included
in this Quarterly Report on Form 10-Q. Factors that could cause or contribute to differences in our actual results include those
discussed in the following subsection, as well as those discussed above in “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and in our Annual Report on Form 10-K for the year ended December 31, 2025. Each of the following
risk factors, either alone or taken together, could adversely affect our business, operating results and financial condition, as well
as adversely affect the value of an investment in our company. The risks and uncertainties described below are not the only ones we face.
Additional risks not currently known to us, or other factors not perceived by us to present significant risks to our business at this
time also may impair our business operations.
53
Summary
of Risk Factors
We
are providing the following summary of the risk factors contained in this Quarterly Report on Form 10-Q to enhance the readability and
accessibility of our risk factor disclosures. We encourage you to carefully review the full risk factors contained in this Quarterly
Report on Form 10-Q in their entirety for additional information regarding the material factors that make an investment in our securities
speculative or risky. These risks and uncertainties include, but are not limited to, the following:
●
We are a clinical-stage
company and have generated no revenue from commercial sales to date;
●
We have incurred net losses
every year since our inception and anticipate that we will continue to incur net losses in the future;
●
If we fail to obtain additional
financing, we will be unable to continue or complete our product development or product commercialization and you will likely lose
your entire investment;
●
Limitations
under General Instructions I.B.6 of Form S-3 (the “baby shelf limitation) may restrict
our ability to raise additional capital;
●
We are highly dependent
on the clinical, regulatory and commercial success of ATNM-400, Actimab-A, Iomab-ACT, and other pipeline candidates which we may
never achieve;
●
We are highly dependent
on our key personnel, most importantly our CEO who we consider a key employee, and the demand for talent in the biotechnology industry
is highly competitive; if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully
implement or execute our business strategy;
●
We continuously evaluate
our business strategy and may modify our strategy as necessary to respond to developments in our business and other factors, and
any such modification such as a divestiture, spin-off, spin-out, merger or acquisition, if not successful, could have a material
adverse effect on our business, financial condition, and results of operations;
●
We may expand our business
through the acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may
also dilute current stockholders’ ownership interests in our company;
●
Our business could be adversely
affected by the effects of future health epidemics;
●
Our business is subject
to cybersecurity risk;
●
We have not demonstrated
that any of our products are safe or effective for any indication and will continue to expend substantial time and resources on clinical
development before any of our current or future product candidates will be eligible for FDA approval, if ever;
●
Our clinical trials may
fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay regulatory approval
and commercialization;
●
Preliminary, Interim, and
“top-line” data from our clinical trials that we announce or publish from time to time may change as more data become
available and are subject to audit and verification procedures that could result in material changes in the final data;
●
Healthcare legislative
reform measures intended to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect
the regulation of the U.S. healthcare system could have a material adverse effect on our business, future revenue, if any, and results
of operations;
●
Changes in the healthcare
industry and in healthcare spending could adversely affect our grant-funded clinical programs, business, financial condition and
results of operations;
54
●
We may rely on third parties
to conduct certain aspects of our clinical trials. If these third parties do not successfully carry out their contractual duties
or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize
our product candidates;
●
We currently depend on
single third-party manufacturers to produce our preclinical and clinical trial drug supplies. Any disruption in the operations of
our current third-party manufacturers, or other third-party manufacturers we may engage in the future, could adversely affect our
business and results of operations;
●
Our product candidates
may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory
approval, limit their commercial potential, or result in significant negative consequences;
●
Disruptions at the FDA
and other government agencies caused by leadership changes, changes to regulatory approach, layoffs, funding shortages or global
health concerns could negatively impact our business;
●
Our ability to advance
clinical development of trials under our CRADA, obtain regulatory interactions/approvals, or secure government-funded grants may
be delayed or disrupted by federal government shutdowns such as the shutdown that began October 1, 2025 and ended on November 12,
2025, as it curtailed operations of key agencies such as the FDA and the National Institutes of Health (“NIH”);
●
Our patent position is
highly uncertain and involves complex legal and factual questions;
●
The use of hazardous materials,
including radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and
may subject us to liability for claims arising from the use or misuse of these materials;
●
Certain provisions of our
Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover
more difficult to complete, even if such a transaction were in our stockholders’ interest; and
●
Our ability to utilize
our net operating loss carryforwards and certain other tax attributes may be limited.
Risks
Related to Our Business
We
are a clinical-stage company and have generated no revenue from commercial sales to date.
We
are a clinical-stage biopharmaceutical company with a limited operating history. We have no products approved for commercial sale and
have not generated any revenue from product sales to date. We will encounter risks and difficulties frequently experienced by early-stage
companies in rapidly evolving fields. If we do not address these risks successfully, our business will suffer.
We
have incurred net losses every year since our inception and anticipate that we will continue to incur net losses in the future.
We
are not profitable and have incurred losses in each period since our inception. As of June 30, 2026 and December 31, 2025, we had an
accumulated deficit of $387.3 million and $409.7 million, respectively. We reported net income of $22.4 million for the six months ended
June 30, 2026 and a net loss of $22.8 million for the six months ended June 30, 2025. We expect to continue to operate at a net loss
as we continue our research and development efforts, continue to conduct clinical trials and develop manufacturing, sales, marketing
and distribution capabilities. There can be no assurance that the products under development by us will be approved for sale in the United
States or elsewhere. Furthermore, there can be no assurance that if such products are approved, they will be successfully commercialized,
which would have an adverse effect on our business prospects, financial condition and results of operation.
55
If
we fail to obtain additional financing, we will be unable to continue or complete our product development and you will likely lose your
entire investment.
As
of the date of filing this report, we expect that our existing resources will be sufficient to fund our planned operations for more than
12 months following the date of this report.
Our
business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial additional
funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business
or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environm