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, 2023 and December 31, 2022, and the
results of operations and cash flows for the three months ended March 31, 2023 and 2022, 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, 2022 in the Company’s Annual Report on Form 10-K. The results of operations for the three months ended March 31, 2023 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,
2023
December 31,
2022
(Unaudited)
Assets
Current Assets:
Cash and cash equivalents
$ 94,522
$ 108,910
Restricted cash - current
399
396
Prepaid expenses and other current assets
3,625
1,636
Total Current Assets
98,546
110,942
Property and equipment, net of accumulated depreciation of $ 536 and $ 487
630
604
Restricted cash – long term
304
302
Operating leases right-of-use assets
2,544
2,341
Finance leases right-of-use assets
2
3
Total Assets
$ 102,026
$ 114,192
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 7,358
$ 10,130
Operating leases current liability
503
494
Finance leases current liability
3
4
Total Current Liabilities
7,864
10,628
Long-term license revenue deferred
35,000
35,000
Long-term operating lease obligations
1,954
2,083
Total Liabilities
44,818
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; 25,729,370 and 25,674,823 shares issued and outstanding, respectively
26
26
Additional paid-in capital
356,984
355,220
Accumulated deficit
( 299,802 )
( 288,765 )
Total Stockholders’ Equity
57,208
66,481
Total Liabilities and Stockholders’ Equity
$ 102,026
$ 114,192
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
2023
2022
Revenue:
Revenue
$ -
$ -
Other revenue
-
940
Total revenue
-
940
Operating expenses:
Research and development, net of reimbursements
7,849
4,369
General and administrative
3,735
1,735
Total operating expenses
11,584
6,104
Loss from operations
( 11,584 )
( 5,164 )
Other income:
Interest income - net
547
35
Total other income
547
35
Net loss
$ ( 11,037 )
$ ( 5,129 )
Net loss per share of common stock – basic and diluted
$ ( 0.43 )
$ ( 0.23 )
Weighted average shares of common stock outstanding – basic and diluted
25,696,623
22,143,974
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, 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.
4
Actinium Pharmaceuticals, Inc.
Condensed Consolidated Statement of Changes
in Stockholders’ Equity
For the Period from January 1, 2022 to March
31, 2022
(Unaudited)
(amounts in thousands, except share amounts)
Common Stock
Additional
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
-
-
421
-
421
Net loss
-
-
-
( 5,129 )
( 5,129 )
Balance, March 31, 2022
22,143,974
$ 22
$ 329,692
$ ( 260,877 )
$ 68,837
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,
2023
2022
Cash Flows Used In Operating Activities:
Net loss
$ ( 11,037 )
$ ( 5,129 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
993
421
Depreciation & amortization expenses
182
137
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 1,989 )
( 114 )
Accounts payable and accrued expenses
( 2,770 )
( 275 )
Other liability
-
( 731 )
Operating lease right-of-use assets
( 336 )
-
Operating lease liabilities
( 120 )
( 90 )
Net Cash Used In Operating Activities
( 15,077 )
( 5,781 )
Cash Flows Used In Investing Activities:
Purchase of property and equipment
( 76 )
( 7 )
Net Cash Used In Investing Activities
( 76 )
( 7 )
Cash Flows Provided By / Used In Financing Activities:
Payments on finance leases
( 1 )
( 22 )
Sales of shares of common stock, net of costs
770
-
Proceeds from the exercise of stock options
1
-
Net Cash Provided By / Used In Financing Activities
770
( 22 )
Net change in cash, cash equivalents, and restricted cash
( 14,383 )
( 5,810 )
Cash, cash equivalents, and restricted cash at beginning of period
109,608
78,221
Cash, cash equivalents, and restricted cash at end of period
$ 95,225
$ 72,411
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 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, 2022.
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, 2022. 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. 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, 2023 and December 31, 2022:
(in thousands)
March 31,
2023
December 31,
2022
Cash and cash equivalents
$ 94,522
$ 108,910
Restricted cash - current
399
396
Restricted cash – long-term
304
302
Cash, cash equivalents and restricted cash
$ 95,225
$ 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.
Leases – The
Company has operating and finance leases for corporate office space and 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.
7
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 had 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 recognized
revenue from grants as it performed services under this arrangement. Associated expenses were 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.
9
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 and nine months ended
March 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)
March 31,
2023
March 31,
2022
Options
3,324
1,333
Restricted Stock Units
325
-
Warrants
1,443
2,052
Total
5,092
3,385
Recently Adopted Accounting
Pronouncements – In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business
Entities about Government Assistance , which provides guidance on disclosure requirements to entities other than not-for-profit entities
about transaction with a government that are accounted for by applying a grant or contribution accounting model by analogy. ASU 2021-10
requires an entity to make annual disclosures related to (1) the nature of the transactions and the related accounting policy used to
account for the government transactions, (2) quantification and disclosure of amounts related to the government transactions included
in balance sheet and income statement financial statement line items, and (3) significant terms and conditions of the government transactions,
including commitments and contingencies. The amendments of ASU 2021-10 are effective January 1, 2022, including interim periods. The Company
adopted this standard effective January 1, 2022, and the standard did not have a material impact on the Company’s 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.
In May 2021, FASB issued ASU
2021-04, Earnings Per Share (topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock
Compensation (Topic 718) and Derivatives and Hedging – Contracts in an Entity’s Own Equity (Subtopic 815-40) – Issuer’s
Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options , which provides guidance
of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification
or exchange as (1) an adjustment to equity and, if so, the related earnings per share (EPS) effects, if any, or (2) an expense and, if
so, the manner and pattern of recognition. The amendments in this ASU are effective January 1, 2022, including interim periods. The Company
adopted this standard effective January 1, 2022 and the standard did not have a material effect on the Company’s financial statements.
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.
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. At March 31, 2023, for capitalization purposes under ASC842, the Company has this operating lease and a finance lease for
office equipment. During the three months ended March 31, 2023, the Company spent $ 0.3 million in improvements at its corporate office
space, which has been included in the value of the operating right-to-use asset as of March 31, 2023.
The components of lease expense are as follows:
Three months ended
(in thousands)
March 31,
2023
March 31,
2022
Operating lease expense
$ 162
$ 93
Finance lease cost
Amortization of right-to-use assets
$ 1
$ 20
Interest on lease liabilities
$ 1
$ 1
Total finance lease cost
$ 2
$ 21
Supplemental cash flow information related to leases
are as follows:
Cash flow information:
Three months ended
(in thousands)
March 31,
2023
March 31,
2022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 150
$ 94
Operating cash flow use from finance leases
$ 1
$ 1
Financing cash flow use from finance leases
$ 1
$ 22
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ -
Finance Leases
$ -
$ -
11
Weighted average remaining lease terms are as follows
at March 31, 2023:
Weighted average remaining lease term:
Operating leases
4.3 years
Finance Leases
0.8 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
4.8 %
Finance Leases
8 %
Maturities of lease liabilities
are as follows:
(in thousands)
Year ending December 31,
Operating
Leases
Finance
Leases
2023 (excluding three months ended March 31, 2023)
$ 456
$ 3
2024
618
-
2025
631
-
2026
643
-
2027
380
-
Total lease payments
$ 2,728
$ 3
Less imputed interest
( 271 )
-
Present value of lease liabilities
$ 2,457
$ 3
Note 4 – Other revenue
The Company determined that
certain collaborations with a third party are within the scope of ASC 606. The collaboration agreement is 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 as revenue over each module and revenue of $ 0.8 million was recognized during the three months
ended March 31, 2022. There was no other revenue recognized from a collaboration during the three months ended March 31, 2023.
The Company had 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 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 for the three months ended March 31, 2022 was $ 0.1 million. There was no
corresponding revenue for the three months ended March 31,
2023.
12
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. There was no Other revenue deferred – current liability at March
31, 2023 and December 31, 2022. Long-term license revenue deferred was $ 35.0 million at March 31, 2023 and December 31, 2022; 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, or 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. Shares of
common stock are offered pursuant to a shelf registration statement on Form S-3 filed with the SEC on August 7, 2020. 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 Securities”). The A&R Sales Agreement modifies the original
Capital on Demand™ Sales Agreement to include B. Riley Securities as an additional sales agent thereunder.
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. For
the three months ended March 31, 2022, there were no sales of common stock.
13
Stock Options
The following is a summary
of stock option activity for the three months ended March 31, 2023:
(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, 2023
3,396
$ 8.00
8.85
$ 15,204
Granted
11
10.89
Exercised
( 1 )
7.00
Cancelled
( 82 )
5.76
Outstanding, March 31, 2023
3,324
8.07
8.50
11,114
Exercisable, March 31, 2023
975
13.66
7.21
2,304
During the three months ended
March 31, 2023, the Company granted new employees options to purchase 11 thousand shares of common stock with an exercise price ranging
from $10.20 to $11.60 per share, a term of 10 years, and a vesting period of 4 years. The options have an aggregated fair value of
$ 82 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 3.59% to 4.21% (2) expected life of 6 years, (3) expected volatility range from 81.3% to 81.4%,
and (4) zero expected dividends.
The fair values of all options
issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at March 31, 2023
was $ 9.0 million related to unvested options, which is expected to be expensed over a weighted average of 3.1 years. During the three
months ended March 31, 2023 and 2022, the Company recorded compensation expense related to stock options of $ 0.8 million and $ 0.4 million,
respectively.
Restricted Stock Units
The following is a summary
of restricted stock unit activity for the three months ended March 31, 2023:
(in thousands, except for per-share amount)
RSUs
Weighted
Average
Grant date Fair Value
Per Share ($)
Outstanding, January 1, 2023
325
5.96
Granted
-
-
Vested
-
-
Outstanding, March 31, 2023
325
5.96
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, $ 1.9 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 December 31, 2022
of $ 1.6 million is expected to be expensed over 2.4 years. During the three months ended March 31, 2023, the Company recorded compensation
expense related to RSUs of $ 0.2 million. There was no compensation expense related to RSUs for the three months ended March 31, 2022.
14
Warrants
Following is a summary of
warrant activity for the three months ended March 31, 2023:
(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, 2023
1,443
$ 16.58
1.33
$ 5
Granted
-
-
Expired
-
-
Outstanding, March 31, 2023
1,443
$ 16.58
1.08
$ 2
Exercisable, March 31, 2023
1,440
$ 15.94
1.08
$ 2
Note 6 - Subsequent Event
Since March 31, 2023, the
Company has sold 0.6 million shares of common stock under its A&R Capital on Demand Sales Agreement, resulting in net proceeds of
$ 5.6 million.
15
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.