Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
The accompanying consolidated
financial statements have been prepared by 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 March 31, 2024 and December 31, 2023, and the
results of operations and cash flows for the three months ended March 31, 2024 and 2023, 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, 2023 in the Company’s Annual Report on Form 10-K. The results of operations for the three months ended March 31, 2024 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)
March 31,
2024
December 31,
2023
(Unaudited)
Assets
Current Assets:
Cash and cash equivalents
$ 84,057
$ 76,677
Prepaid expenses and other current assets
1,316
1,586
Total Current Assets
85,373
78,263
Property and equipment, net of accumulated depreciation of $ 760 and $ 694
496
550
Restricted cash – long term
316
313
Operating leases right-of-use assets
2,140
2,289
Finance leases right-of-use assets
27
30
Total Assets
$ 88,352
$ 81,445
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 7,513
$ 7,953
Operating leases current liability
540
530
Finance leases current liability
11
11
Total Current Liabilities
8,064
8,494
Long-term license revenue deferred
35,000
35,000
Long-term operating lease obligations
1,414
1,553
Long-term finance lease obligations
17
19
Total Liabilities
44,495
45,066
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; 29,396,411 and 27,634,213 shares issued and outstanding, respectively
29
28
Additional paid-in capital
390,081
373,934
Accumulated deficit
( 346,253 )
( 337,583 )
Total Stockholders’ Equity
43,857
36,379
Total Liabilities and Stockholders’ Equity
$ 88,352
$ 81,445
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
March 31
2024
2023
Revenue:
Revenue
$ -
$ -
Other revenue
-
-
Total revenue
-
-
Operating expenses:
Research and development, net of reimbursements
6,635
7,849
General and administrative
2,962
3,735
Total operating expenses
9,597
11,584
Loss from operations
( 9,597 )
( 11,584 )
Other income:
Interest income - net
927
547
Total other income
927
547
Net loss
$ ( 8,670 )
$ ( 11,037 )
Net loss per share of common stock – basic and diluted
$ ( 0.31 )
$ ( 0.43 )
Weighted average shares of common stock outstanding – basic and diluted
27,886,486
25,696,623
See accompanying notes to the condensed consolidated
financial statements.
3
Actinium Pharmaceuticals, Inc.
Condensed Consolidated Statement of Changes
in Stockholders’ Equity
For the Period from January 1, 2024 to March
31, 2024
(Unaudited)
(amounts in thousands, except share amounts)
Common Stock
Additional
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance, January 1, 2024
27,634,213
$ 28
$ 373,934
$ ( 337,583 )
$ 36,379
Stock-based compensation
-
-
1,378
-
1,378
Sale of common stock, net of offering costs
1,752,050
1
14,694
-
14,695
Issuance of common stock from exercise of stock options
10,148
-
75
-
75
Net loss
-
-
-
( 8,670 )
( 8,670 )
Balance, March 31, 2024
29,396,411
$ 29
$ 390,081
$ ( 346,253 )
$ 43,857
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, 2023 to March
31, 2023
(Unaudited)
(amounts in thousands, except share amounts)
Common Stock
Additional
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance, January 1, 2023
25,674,823
$ 26
$ 355,220
$ ( 288,765 )
$ 66,481
Stock-based compensation
-
-
993
-
993
Sale of common stock, net of offering costs
54,414
-
770
-
770
Issuance of common stock from exercise of stock options
133
-
1
-
1
Net loss
-
-
-
( 11,037 )
( 11,037 )
Balance, March 31, 2023
25,729,370
$ 26
$ 356,984
$ ( 299,802 )
$ 57,208
See accompanying notes to
the condensed consolidated financial statements.
5
Actinium Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(amounts in thousands)
For the
Three Months Ended
March 31,
2024
2023
Cash Flows Used In Operating Activities:
Net loss
$ ( 8,670 )
$ ( 11,037 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
1,378
993
Depreciation & amortization expenses
216
182
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
271
( 1,989 )
Accounts payable and accrued expenses
( 440 )
( 2,770 )
Operating lease right-of-use assets
-
( 336 )
Operating lease liabilities
( 129 )
( 120 )
Net Cash Used In Operating Activities
( 7,374 )
( 15,077 )
Cash Flows Used In Investing Activities:
Purchase of property and equipment
( 11 )
( 76 )
Net Cash Used In Investing Activities
( 11 )
( 76 )
Cash Flows Provided By Financing Activities:
Payments on finance leases
( 2 )
( 1 )
Sales of shares of common stock, net of costs
14,695
770
Proceeds from the exercise of stock options
75
1
Net Cash Provided By Financing Activities
14,768
770
Net change in cash, cash equivalents, and restricted cash
7,383
( 14,383 )
Cash, cash equivalents, and restricted cash at beginning of period
76,990
109,608
Cash, cash equivalents, and restricted cash at end of period
$ 84,373
$ 95,225
Supplemental disclosure of cash flow information:
Cash paid for interest
$ -
$ -
Cash paid for income taxes
$ -
$ -
See accompanying notes to the condensed consolidated
financial statements.
6
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 biopharmaceutical company developing ARCs and other targeted radiotherapies to deliver cancer-killing
radiation with cellular level precision to treat patients with high unmet medical needs.
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 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, 2023.
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 Report on Form 10-K for the year ended December 31, 2023. 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 consolidated financial
statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
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 March 31, 2024 and December 31, 2023:
(in thousands)
March 31,
2024
December 31,
2023
Cash and cash equivalents
$ 84,057
$ 76,677
Restricted cash – long-term
316
313
Cash, cash equivalents and restricted cash
$ 84,373
$ 76,990
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 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.
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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.
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 .
Grant Revenue –
The Company has a grant from a government-sponsored entity for research and development related activities that provided 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.
8
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.
Research and Development
Costs - Research and development costs are expensed as incurred. These costs include the costs of manufacturing drug product, the
costs of clinical trials, costs of employees and associated overhead, and depreciation and amortization costs related to facilities and
equipment. Research and development reimbursements are recorded by the Company as a reduction of research and development costs.
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 Loss Per Common Share
- Basic loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of
shares of common stock outstanding during the reporting period. For periods of net loss, diluted 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 ended March
31, 2024 and 2023, the Company’s potentially dilutive shares, which include outstanding common stock options, restricted stock units
and warrants, have not been included in the computation of diluted net loss per share as the result would have been anti-dilutive.
9
(in thousands)
March 31,
2024
March 31,
2023
Stock Options
5,421
3,324
Restricted Stock Units
305
325
Warrants
1,439
1,443
Total
7,165
5,092
Recently Issued Accounting
Pronouncements – In December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ,
to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide improvements primarily
related to the rate reconciliation and income taxes paid information included in income tax disclosures. The Company would be required
to disclose additional information regarding reconciling items equal to or greater than five percent of the amount computed by multiplying
pretax income (loss) by the applicable statutory tax rate. Similarly, the Company would be required to disclose income taxes paid (net
of refunds received) equal to or greater than five percent of total income taxes paid (net of refunds received). The amendments in ASU
2023-09 are effective January 1, 2025, including interim periods. Early adoption is permitted for annual financial statements that have
not yet been issued or made available for issuance. The Company will evaluate the impact of ASU 2023-09 on its financial statements.
In November 2023, FASB issued
ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures , which provides improvements
to reportable segment disclosure requirements, primarily through enhanced disclosures around segment expenses. ASU 2023-07 requires the
Company to disclose significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”)
and included within each reported measure of segment profit or loss. ASU 2023-07 also requires that the Company disclose an amount for
other segment items by reportable segment, a description of their composition and provide all annual disclosures about a reportable segment’s
profit or loss and assets pursuant to Topic 280 during interim periods. The Company must also disclose the CODM’s title and position,
as well as certain information around the measures used by the CODM and an explanation of how the CODM uses the reported measures in assessing
segment performance and deciding how to allocate resources. For public entities with a single reportable segment, the entity must provide
all the disclosures required pursuant to ASU 2023-07 and all existing segment disclosures under Topic 280. The amendments of ASU 2023-07
are effective for the Company for annual periods beginning January 1, 2024, and effective for interim periods beginning January 1, 2025.
Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company
will evaluate the impact of ASU 2023-07 on its financial statements.
In October 2021, FASB issued
ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers ,
which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance with
ASC 606. To achieve this, an acquirer may assess how the acquiree applied ASC 606 to determine what to record for the acquired revenue
contracts. Generally, this should result in an acquirer recognizing and measuring the acquired contract assets and contract liabilities
consistent with how they were recognized and measured in the acquiree’s financial statements. The amendments of ASU 2021-08 are
effective January 1, 2023, including interim periods. The Company will evaluate the impact of ASU 2021-08 on any future business combinations
the Company may enter in the future.
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 U.S. Food and Drug Administration (“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.
10
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 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 majority
of the Company’s leases as the reasonably certain threshold is not met.
At March 31, 2024, the Company
has two leases which have been capitalized in accordance with ASC 842, one for corporate office 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 5 years 2 months , with an expiration
date on 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. During 2023, the Company spent $ 0.5 million in improvements at its corporate office space, which has been included
in the value of the operating right-to-use asset.
The components of lease expense are as follows:
Three months ended
(in thousands)
March 31,
2024
March 31,
2023
Operating lease expense
$ 173
$ 162
Finance lease cost
Amortization of right-to-use assets
$ 2
$ 1
Interest on lease liabilities
$ 1
$ 1
Total finance lease cost
$ 3
$ 2
11
Supplemental cash flow information related to leases
are as follows:
Cash flow information:
Three months ended
(in thousands)
March 31,
2024
March 31,
2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 153
$ 150
Operating cash flow use from finance leases
$ 3
$ 1
Financing cash flow use from finance leases
$ 2
$ 1
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 March 31, 2024:
Weighted average remaining lease term:
Operating leases
3.3 years
Finance Leases
2.8 years
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
4.8 %
Finance Leases
6.2 %
Maturities of lease liabilities
are as follows:
(in thousands)
Year ending December 31,
Operating
Leases
Finance
Leases
2024 (excluding three months ended March 31, 2024)
466
8
2025
630
11
2026
643
11
2027
380
-
Total lease payments
$ 2,119
$ 30
Less imputed interest
( 165 )
( 2 )
Present value of lease liabilities
$ 1,954
$ 28
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 performed
services under this arrangement. Associated expenses are recognized when incurred as research and development expense. There was no other
revenue recognized from this grant for the three months ended March 31, 2024 and 2023, 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 payment of $ 35 million from Immedica,
which was received in May 2022. Under the terms of the License Agreement, the Company is eligible to receive regulatory and commercial
milestone payments and is entitled to receive royalties in the mid-20 percent range on net sales of the product in certain countries that
may result from the License Agreement. The Company will continue to be responsible for certain clinical development activities and the
manufacturing of Iomab-B and will retain commercialization rights in the U.S. and rest of the world.
12
The Company’s contract
liabilities are recorded within Other revenue deferred – current liability or Long-term license revenue deferred in its condensed
consolidated balance sheets, depending on the short-term or long-term nature of the payments to be recognized. The Company’s contract
liabilities primarily consist of advanced payments from licensees. Long-term license revenue deferred was $ 35.0 million at March 31, 2024
and March 31, 2023; this deferred revenue will be recognized upon European Union regulatory approval of Iomab B.
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 are 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 new 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 Amended Sales Agreement.
For the three months ended
March 31, 2024, the Company sold 1.8 million shares of common stock, resulting in gross proceeds of $ 15.0 million and net proceeds of
$ 14.7 million. For the three months ended March 31, 2023, the Company sold 0.1 million shares of common stock, resulting in gross proceeds
and net proceeds of $ 0.8 million.
Stock Options
The following is a summary
of stock option activity for the three months ended March 31, 2024:
(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, 2024
5,445
$ 6.80
8.70
$ 373
Granted
-
-
Exercised
( 10 )
7.39
Cancelled
( 14 )
5.76
Outstanding, March 31, 2024
5,421
6.80
8.49
12,545
Exercisable, March 31, 2024
1,797
9.84
7.32
3,144
During the three months ended
March 31, 2024, the Company did not grant any stock options. The fair values of all options issued and outstanding are being amortized
over their respective vesting periods. The unrecognized compensation expense at March 31, 2024 was $ 13.2 million related to unvested options,
which is expected to be expensed over a weighted average of 3.2 years. During the three months ended March 31, 2024 and 2023, the Company
recorded compensation expense related to stock options of $ 1.2 million and $ 0.8 million, respectively.
13
Restricted Stock Units
The following is a summary
of restricted stock unit activity for the three months ended March 31, 2024:
(in thousands, except for per-share amount)
RSUs
Weighted
Average
Grant date Fair Value
Per Share ($)
Outstanding, January 1, 2024
305
5.89
Granted
-
-
Vested
-
-
Outstanding, March 31, 2024
305
5.89
The RSUs vest at the earliest
of a change of control event, the termination of the recipient’s continuous service status for any reason other than by the Company
for cause and the third anniversary of the date of the grant. The fair value of the RSUs, $ 1.8 million, was determined based on the stock
prices on the dates of the grants and is being recognized over three years . The unrecognized compensation expense at March 31, 2024 of
$ 0.8 million is expected to be expensed over 1.4 years. During the three months ended March 31, 2024 and 2023, the Company recorded compensation
expense related to RSUs of $ 0.1 million and $ 0.2 million, respectively.
Warrants
Following is a summary of
warrant activity for the three months ended March 31, 2024:
(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, 2024
1,442
$ 16.42
0.34
$ -
Granted
-
-
Expired
( 3 )
166.50
Outstanding, March 31, 2024
1,439
$ 16.08
0.09
$ -
Exercisable, March 31, 2024
1,436
$ 15.58
0.08
$ -
Note 6 - Subsequent Events
Since March 31, 2024, the Company sold 0.4 million shares of common
stock under its A&R Capital on Demand Sales Agreement, resulting in net proceeds of $ 3.4 million.
On April 23, 2024, outstanding warrants to purchase up to 1.4 million
shares of the Company’s common stock, with an exercise price of $ 15.00 per share, expired, according to their terms. Following the
expiration of such warrants, the Company has less than thirteen thousand warrants outstanding.
14
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.