Item 8. Financial Statements and Supplementary Data
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and Board of Directors of
Actinium Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying
consolidated balance sheets of Actinium Pharmaceuticals, Inc. (the “Company”) as of December 31, 2023 and 2022, and the
related consolidated statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the
period ended December 31, 2023 and the related notes (collectively referred to as the “financial statements”). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31,
2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023,
in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from
the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Marcum llp
Marcum llp
We have served as the Company’s auditor since 2012 .
Houston, Texas
March 29, 2024
F- 1
Actinium Pharmaceuticals, Inc.
Consolidated Balance Sheets
(amounts in thousands, except share and per share
data)
December 31,
2023
December 31,
2022
Assets
Current Assets:
Cash and cash equivalents
$ 76,677
$ 108,910
Restricted cash – current
-
396
Prepaid expenses and other current assets
1,586
1,636
Total Current Assets
78,263
110,942
Property and equipment, net of accumulated depreciation of $ 694 and $ 487
550
604
Restricted cash – long term
313
302
Operating lease right-of-use assets
2,289
2,341
Finance leases right-of-use assets
30
3
Total Assets
$ 81,445
$ 114,192
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 7,953
$ 10,130
Operating leases current liability
530
494
Finance leases current liability
11
4
Total Current Liabilities
8,494
10,628
Long-term license revenue deferred
35,000
35,000
Long-term operating lease obligations
1,553
2,083
Long-term finance lease obligations
19
-
Total Liabilities
45,066
47,711
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; 27,634,213 and 25,674,823 shares issued and outstanding at December 31, 2023 and 2022, respectively
28
26
Additional paid-in capital
373,934
355,220
Accumulated deficit
( 337,583 )
( 288,765 )
Total Stockholders’ Equity
36,379
66,481
Total Liabilities and Stockholders’ Equity
$ 81,445
$ 114,192
See accompanying notes to the consolidated financial
statements.
F- 2
Actinium Pharmaceuticals, Inc.
Consolidated Statements of Operations
(amounts in thousands, except share and per share
data)
For the Year ended
December 31,
2023
2022
Revenue
Revenue
$ -
$ -
Other Revenue
81
1,030
Total revenue
81
1,030
Operating expenses:
Research and development, net of reimbursements
38,670
23,135
General and administrative
13,331
11,999
Total operating expenses
52,001
35,134
Loss from operations
( 51,920 )
( 34,104 )
Other income:
Interest income – net
3,102
1,087
Total other income
3,102
1,087
Net loss
$ ( 48,818 )
$ ( 33,017 )
Net loss per common share – basic and diluted
$ ( 1.83 )
$ ( 1.37 )
Weighted average common shares outstanding – basic and diluted
26,604,045
24,141,545
See accompanying notes to the consolidated financial
statements.
F- 3
Actinium Pharmaceuticals, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
For the Years Ended December 31, 2023 and 2022
(amounts in thousands, except share amounts)
Additional
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance, January 1, 2022
22,143,974
$ 22
$ 329,271
$ ( 255,748 )
$ 73,545
Stock-based compensation
19,639
-
2,795
-
2,795
Sale of common stock, net of offering costs
3,511,210
4
23,154
-
23,158
Net loss
-
-
-
( 33,017 )
( 33,017 )
Balance, December 31, 2022
25,674,823
$ 26
$ 355,220
$ ( 288,765 )
$ 66,481
Stock-based compensation
13,144
-
3,842
-
3,842
Sale of common stock, net of offering costs
1,902,005
2
14,610
-
14,612
Issuance of common stock from exercise of stock options
44,241
-
262
262
Net loss
-
-
-
( 48,818 )
( 48,818 )
Balance, December 31, 2023
27,634,213
$ 28
$ 373,934
$ ( 337,583 )
$ 36,379
See accompanying notes to the consolidated financial
statements.
F- 4
Actinium Pharmaceuticals, Inc.
Consolidated Statements of Cash Flows
(amounts in thousands)
For the Year ended
December 31,
2023
2022
Cash Flows from Operating Activities:
Net loss
$ ( 48,818 )
$ ( 33,017 )
Adjustments to reconcile net loss to net cash used in/provided by operating activities:
Stock-based compensation expense
3,842
2,795
Depreciation and amortization expense
790
699
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
49
( 158 )
Accounts payable and accrued expenses
( 2,177 )
4,595
Other revenue deferred – current liability
-
( 998 )
Long-term license revenue deferred
-
35,000
Operating lease right-of-use assets
( 527 )
-
Operating lease liabilities
( 494 )
( 272 )
Net Cash Used In/Provided By Operating Activities
( 47,335 )
8,644
Cash Flows Used in Investing Activities:
Purchase of property and equipment
( 153 )
( 366 )
Net Cash Used In Investing Activities
( 153 )
( 366 )
Cash Flows from Financing Activities:
Payments on finance leases
( 4 )
( 49 )
Proceeds from sales of shares of common stock, net of offering costs
14,612
23,158
Proceeds from the exercise of stock options
262
-
Net Cash Provided By Financing Activities
14,870
23,109
Net change in cash, cash equivalents and restricted cash
( 32,618 )
31,387
Cash, cash equivalents and restricted cash at beginning of year
109,608
78,221
Cash, cash equivalents and restricted cash at end of year
$ 76,990
$ 109,608
Supplemental disclosures of cash flow information:
Cash paid for interest
$ -
$ -
Cash paid for taxes
$ -
$ -
Supplemental disclosure of non-cash investing and financing activities:
Right-of-use assets obtained in exchange for lease liabilities
$ 30
$ 2,605
Equipment obtained in exchange for security deposit
$ -
$ 50
See accompanying notes to the consolidated financial
statements.
F- 5
Actinium Pharmaceuticals, Inc.
Notes to Consolidated Financial Statements
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.
Principles of Consolidation
- The consolidated financial statements include the Company’s accounts and those of the Company’s wholly owned subsidiaries.
All significant intercompany accounts and transactions have been eliminated.
Use of Estimates in Financial
Statement Presentation - The preparation of these consolidated financial statements in conformity with accounting principles generally
accepted in the United States of America 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 and 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.
Following is a summary of
cash, cash equivalents and restricted cash at December 31, 2023 and December 31, 2022:
(in thousands)
December 31,
2023
December 31,
2022
Cash and cash equivalents
$ 76,677
$ 108,910
Restricted cash – current
-
396
Restricted cash – long-term
313
302
Cash, cash equivalents and restricted cash
$ 76,990
$ 109,608
Restricted cash relates to
certificates of deposit held as collateral for letters of credit issued in connection with the Company’s leases of corporate office
spaces.
Property and
Equipment - Machinery and equipment are recorded at cost and depreciated on a straight-line basis over estimated useful lives of
three to five years. Furniture and fixtures are recorded at cost and depreciated on a straight-line basis over estimated useful
lives of seven years. When assets are retired, the cost and related accumulated depreciation are removed from the accounts, and any
related gain or loss is reflected in operations. Repairs and maintenance expenditures are charged to operations when incurred. Capitalized lease
assets are recorded at the lesser of the present value of minimum lease payments or fair value and amortized over the estimated
useful life of the related property or term of the lease.
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.
F- 6
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.
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 .
F- 7
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.
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.
F- 8
Income Taxes - The
Company accounts for income taxes in accordance with ASC 740 Income Taxes , which requires the asset and liability method to calculate
deferred taxes. Deferred taxes are recognized based on the differences between the financial reporting and income tax bases of assets
and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company
reviews deferred tax assets for a valuation allowance based upon whether it is more likely than not that the deferred tax asset will be
fully realized.
ASC 740 prescribes guidance
for the financial statement recognition, measurement and disclosure of uncertain tax positions. Tax positions must meet a “more-likely-than-not”
recognition threshold to be recognized. There were no tax positions for which it is considered reasonably possible that the total amounts
of unrecognized tax benefits will significantly increase or decrease within the next year. The Company recognizes interest related to
unrecognized tax benefits in interest expense and penalties in operating expenses.
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
common shares 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 years ended December
31, 2023 and 2022, 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.
(in thousands)
December 31,
2023
December 31,
2022
Stock Options
5,445
3,396
Restricted Stock Units
305
325
Warrants
1,442
1,443
Total
7,192
5,164
Subsequent Events -
The Company’s management reviewed all material events through the date the consolidated financial statements were issued for subsequent
event disclosure consideration.
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.
F- 9
Note 2 - Prepaid Expenses and Other Current
Assets
Prepaid expenses and other
current assets consisted of the following at December 31, 2023 and 2022:
December 31,
December 31,
2023
2022
Prepaid insurance
$ 614
$ 684
Prepaid clinical trial expenses
746
887
Other prepaid expenses and other current assets
226
65
Total prepaid expenses and other current assets
$ 1,586
$ 1,636
Note 3 - Property and Equipment
Property and equipment consisted
of the following at December 31, 2023 and 2022:
December 31,
December 31,
(in thousands)
Lives
2023
2022
Lab equipment
5 years
$ 806
$ 776
Office equipment and furniture
3 - 7 years
438
315
Less: accumulated depreciation
( 694 )
( 487 )
Property and equipment, net
$ 550
$ 604
Depreciation expense consisted
of the following for the years ended December 31, 2023 and 2022, respectively:
December 31,
December 31,
(in thousands)
2023
2022
Research and development
$ 175
$ 141
General and administrative
32
11
Total depreciation expense
$ 207
$ 152
Note 4 - 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 Company’s
leases as the reasonably certain threshold is not met.
At December 31,
2023, 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 the year ended December 31, 2023, the Company spent
$ 0.5 million on improvements at its corporate office space, which has been included in the value of the operating right-to-use
asset.
F- 10
The components of lease expense are as follows:
(in thousands)
Year ended
December 31,
2023
Year ended
December 31,
2022
Operating lease expense
$ 691
$ 584
Finance lease cost
Amortization of right-to-use assets
$ 3
$ 55
Interest on lease liabilities
$ -
$ 2
Total finance lease cost
3
$ 57
Supplemental cash flow information related to leases
are as follows:
Year ended
(in thousands)
December 31,
2023
December 31,
2022
Cash flow information:
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 606
$ 352
Operating cash flow use from finance leases
$ -
$ 2
Financing cash flow use from finance leases
$ 4
$ 49
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ 2,605
Finance leases
$ 30
$ -
Weighted average remaining lease terms are as follows
at December 31, 2023:
Weighted average remaining lease term:
Operating leases
3.6 years
Finance leases
3.0 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 reflect 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 %
F- 11
Maturities of lease liabilities are as follows:
Year ending December 31,
Operating
Leases
Finance
Leases
2024
618
11
2025
630
11
2026
643
11
2027
380
-
Total lease payments
$ 2,271
$ 33
Less imputed interest
( 188 )
( 3 )
Present value of lease liabilities
$ 2,083
$ 30
Note 5 - Other Revenue
The Company determined that
certain collaborations with a third party were within the scope of ASC 606. The collaboration agreement was made up of multiple modules
related to various research activities. The Company identified a single performance obligation to provide research services within each
module for which the Company receives monetary consideration. The third party can choose to proceed with each module or can terminate
the agreement at any time. The Company recognizes revenue for each module on a straight-line basis over the expected module period. Revenue
for succeeding modules is not recognized until all contingencies are resolved, inclusive of the third party’s ability to terminate
the module. The consideration is recognized to revenue over each module. There was no corresponding revenue recognized from a collaboration
during the year ended December 31, 2023 and revenue of $ 0.9 million was recognized during the year ended December 31, 2022.
The Company has a grant from
a government-sponsored entity for research and development related activities that provides for payments for reimbursed costs, which includes
overhead and general and administrative costs as well as an administrative fee. The Company recognized revenue from grants as it performed
services under this arrangement. Associated expenses are recognized when incurred as research and development expense. Other revenue recognized
from this grant during the years ended December 31, 2023 and December 31, 2022 was $ 0.1 million in each year.
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.
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 December 31,
2023 and December 31, 2022; this deferred revenue will be recognized upon European Union regulatory approval of Iomab B.
Note 6 - 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.
F- 12
Note 7 - 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), and amended on February 2, 2024,
which was 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.
During the year ended December
31, 2023, the Company sold 1.9 million shares of common stock, resulting in gross proceeds of $ 15.1 million and net proceeds of $ 14.6
million. During the year ended December 31, 2022, the Company sold 3.5 million shares of common stock, resulting in gross proceeds of
$ 23.9 million and net proceeds of $ 23.2 million.
The Company presently has one equity compensation
plan, the 2019 Amended and Restated Stock Plan, (the “2019 Plan”). The 2019 Plan has an expiration date of October 18,
2029 and the number of shares of our common stock authorized under the plan for grant to employees, directors and consultants is 9,333,333
shares.
The Company had two equity compensation plans that
expired on September 9, 2023; the Company’s Amended and Restated 2013 Stock Plan and the Company’s 2013 Equity Incentive Plan.
Stock Options
Following is a summary of
stock option activity for the years ended December 31, 2023 and 2022:
(in thousands, except for per-share amount)
Number of
Options
Weighted
Average
Exercise
Price ($)
Weighted
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value ($)
Outstanding, January 1, 2022
1,362
12.45
8.69
-
Granted
2,094
5.25
Exercised
-
-
Cancelled
( 60 )
12.90
Outstanding, December 31, 2022
3,396
8.00
8.85
15,204
Granted
2,402
5.28
Exercised
( 44 )
5.92
Cancelled
( 309 )
8.30
Outstanding, December 31, 2023
5,445
6.80
8.70
373
Exercisable, December 31, 2023
1,519
10.63
7.18
69
During 2023, the Company
granted its employees and members of the Board of Directors options to purchase 2.4 million shares of common stock with an exercise
price ranging from $ 5.00 to $ 11.60 per share, a term of 10 years, and a vesting period from 4 to 4.2 years. The options have an
aggregated fair value of $ 9.0 million 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 3.5 % to 4.82 % (2) expected life of 6 years, (3) expected
volatility range from 79.0 % to 81.6 %, and (4) zero expected dividends.
F- 13
During 2022, the Company granted
its employees and members of the Board of Directors options to purchase 2.1 million shares of common stock with an exercise price ranging
from $ 4.96 to $ 13.54 per share, a term of 10 years, and a vesting period from 4 to 4.2 years. The options have an aggregated fair
value of $ 7.7 million 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 1.5 % to 4.3 % (2) expected life of 6 years, (3) expected volatility range from 78.8 % to 81.1 %,
and (4) zero expected dividends.
During the years ended December
31, 2023 and 2022, options to purchase 309 thousand and 60 thousand common shares were cancelled, respectively, upon the termination of
employment. During 2023, 44 thousand options were exercised for shares of common stock. There were no exercises of options during 2022.
The fair values of all options
issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at December 31,
2023 was $ 14.4 million related to unvested options, which is expected to be expensed over a weighted average of 3.4 years. During 2023
and 2022, the Company recorded total option expense of $ 3.2 million and $ 2.5 million, respectively.
Restricted Stock Units
Following is a summary of
restricted stock unit (“RSUs”) activity for the years ended December 31, 2023 and 2022:
(in thousands, except for per-share amount)
RSUs
Weighted
Average
Grant Date Fair Value Per Share ($)
Outstanding, January 1, 2022
-
-
Granted
325
5.96
Vested
-
-
Outstanding, December 31, 2022
325
5.96
Granted
5
8.31
Vested
-
-
Cancelled
( 25 )
7.31
Outstanding, December 31, 2023
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 each RSU grant is being recognized over its respective three-year period. The unrecognized compensation
expense at December 31, 2023 of $ 1.0 million is expected to be expensed over a weighted average of 1.7 years. During 2023 and 2022, the
Company recorded compensation expense related to RSUs of $ 0.6 million and $ 0.2 million, respectively.
F- 14
Warrants
Following is a summary of
warrant activities for the years ended December 31, 2023 and 2022:
(in thousands, except for per-share amounts)
Number of
Warrants
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic
Value
Outstanding, January 1, 2022
2,112
20.52
1.76
276
Granted
-
-
Exercised
-
-
Cancelled
( 669 )
29.01
Outstanding, December 31, 2022
1,443
16.58
1.33
5
Granted
2
8.77
10.00
Exercised
-
-
Cancelled
( 3 )
106.80
Outstanding, December 31, 2023
1,442
16.42
0.34
-
Exercisable, December 31, 2023
1,438
15.79
0.33
-
On August 2, 2022, warrants
to purchase an aggregate of 0.6 million shares of common stock expired. These warrants were issued on August 2, 2017, when the Company
completed an underwritten offering of 0.7 million shares of common stock and warrants to purchase 0.6 million shares of common stock at
a price of $ 22.50 per share and related warrant. The warrants were exercisable for a period of 5 years at an exercise price of $ 31.50
per share.
During the years ended December
31, 2023 and 2022, the Company recorded stock-based compensation expense related to warrants of $ 6 thousand and $ 6 thousand, respectively.
Note 8 - Income Taxes
Deferred income taxes reflect
the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities at December
31, 2023 and 2022 are as follows:
(in thousands)
2023
2022
Deferred tax assets:
Net operating losses carry forward
$ 41,698
$ 44,233
Deferred revenue
8,219
-
Share-based compensation
1,512
1,334
Research and development/orphan drug credits
20,509
17,247
Capitalized research and development expenses
18,684
13,210
Others
( 57 )
69
Less: valuation allowance
( 90,566 )
( 76,093 )
Deferred tax assets, net
$ -
$ -
The Company has recorded a
valuation allowance of $ 90.6 million and $ 76.1 million against its deferred tax assets at December 31, 2023 and 2022 respectively, because
management determined that it is not more-likely-than not that those assets will be realized.
For federal income tax purposes,
the Company has $ 165.1 million of unused net operating losses (“NOLs”) at December 31, 2023 available for carry forward to
future years. NOLs of $ 104.8 million generated prior to 2018 will begin to expire if unused beginning in 2024 when approximately $ 3.9
million in NOLs are due to expire. Our largest NOLs will begin to expire in 2034 - 2037, with each year in excess of $ 15 million. NOLs
generated in 2018 and later years of $ 60.3 million have an indefinite life, but will be limited to 80% of their value if used in a tax
year ending after January 1, 2023.
For state income tax purposes,
the Company has $ 283.0 million of unused NOLs at December 31, 2023 available for carry forward to future years. These NOLs will begin
to expire in 2034 if unused.
F- 15
The Company has federal research
and development tax credits of $ 5.1 million at December 31, 2023 which will begin to expire in 2033 if unused and orphan drug credits
of $ 15.4 million which will begin to expire in 2037 if unused.
Federal and state tax laws
impose limitations on the utilization of net operating losses and credit carryforwards in the event of an ownership change for tax purposes,
as defined in Section 382 of the Internal Revenue Code. Accordingly, the Company’s ability to utilize these carryforwards may be
limited as a result of an ownership change which may have already happened or may happen in the future. Such an ownership change could
result in a limitation in the use of the net operating losses in future years and possibly a reduction of the net operating losses available.
The Tax Cuts and Jobs Act
of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021.
Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize them over
five years for U.S. activities and 15 years for non-U.S. activities. Since this has been the Company's policy since 2018, the current
year capitalization of research and development costs in accordance with IRC 174 was $ 36.9 million for a total accumulated gross amount
of $ 79.6 million as of December 31, 2023.
The
difference between the income tax provision and the amount that would result if the U.S. Federal statutory rates were applied to pre-tax
losses for the year ended December 31, 2023 and 2022 are as follows:
(in thousands)
December 31,
2023
December 31,
2022
Federal statutory income taxes
$ ( 10,252 )
( 21.0 )%
$ ( 6,943 )
( 21.0 )%
State income taxes
( 1,743 )
( 3.6 )%
( 4,863 )
( 14.7 )%
Deferred true-up
176
0.4 %
89
0.3 %
Research and development/orphan drug tax credit
( 3,263 )
( 6.7 )%
( 2,711 )
( 8.2 )%
Other
608
1.2 %
934
2.8 %
Change in valuation allowance
14,474
29.7 %
13,494
40.8 %
Provision for income tax
$ -
-
$ -
-
Note 9 - Subsequent Event
Since
December 31, 2023, the Company has sold 1.8 million shares of common stock under its A&R Sales Agreement, resulting in net proceeds
of $ 14.7 million.
F- 16
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.