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 June 30, 2022 and
December 31, 2021, and the results of operations and cash flows for the three and six months ended June 30, 2022 and 2021, 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, 2021 in the Company’s Annual Report on Form 10-K. The results of operations for the three and six months
ended June 30, 2022 are not necessarily indicative of the operating results for the full year.
1
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(In
thousands, except share and per share data)
June 30,
2022
December 31,
2021
(Unaudited)
(Audited)
Assets
Current Assets:
Cash and cash equivalents
$ 116,330
$ 77,829
Restricted cash
392
392
Security deposit
50
50
Prepaid expenses and other current assets
1,525
1,478
Total Current Assets
118,297
79,749
Property and equipment, net of accumulated depreciation of $ 395 and $ 335
557
340
Security deposit – long term
299
-
Operating leases right-of-use assets
2,629
241
Finance leases right-of-use assets
18
58
Total Assets
$ 121,800
$ 80,388
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 5,767
$ 5,535
Other revenue deferred– current liability
204
998
Operating leases current liability
292
245
Finance leases current liability
19
62
Total Current Liabilities
6,282
6,840
Long-term license revenue deferred
35,000
-
Long-term operating leases obligations
2,335
-
Long-term finance leases obligations
2
3
Total Liabilities
$ 43,619
$ 6,843
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; 24,870,623 and 22,143,974 shares issued and outstanding, respectively
25
22
Additional paid-in capital
346,800
329,271
Accumulated deficit
( 268,644 )
( 255,748 )
Total Stockholders’ Equity
78,181
73,545
Total Liabilities and Stockholders’ Equity
$ 121,800
$ 80,388
See
accompanying notes to the condensed consolidated financial statements.
2
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
(In
thousands, except share and per share data)
For the
Three Months Ended
June 30,
For the
Six Months Ended
June 30,
2022
2021
2022
2021
Revenue
Revenue
$ -
$ -
$ -
$ -
Other revenue
45
266
985
888
Total revenue
45
266
985
888
Operating expenses:
Research and development, net of reimbursements
4,662
3,631
9,031
7,907
General and administrative
3,233
1,710
4,968
3,428
Total operating expenses
7,895
5,341
13,999
11,335
Loss from operations
( 7,850 )
( 5,075 )
( 13,014 )
( 10,447 )
Other income:
Interest income - net
83
54
118
106
Total other income
83
54
118
106
Net loss
$ ( 7,767 )
$ ( 5,021 )
$ ( 12,896 )
$ ( 10,341 )
Net loss per common share – basic and diluted
$ ( 0.33 )
$ ( 0.25 )
$ ( 0.56 )
$ ( 0.54 )
Weighted average common shares outstanding – basic and diluted
23,731,886
20,231,278
22,942,317
19,308,487
See
accompanying notes to the condensed consolidated financial statements.
3
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statement of Changes in Stockholders’ Equity
For
the Three and Six Months Ended June 30, 2022
(Unaudited)
(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
Stock-based compensation
-
-
425
-
425
Sale of common stock, net of issuance costs
2,726,649
3
16,683
-
16,686
Net loss
-
-
-
( 7,767 )
( 7,767 )
Balance, June 30, 2022
24,870,623
$ 25
$ 346,800
$ ( 268,644 )
$ 78,181
See
accompanying notes to the condensed consolidated financial statements.
4
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statement of Changes in Stockholders’ Equity
For
the Three and Six Months Ended June 30, 2021
(Unaudited)
(In
thousands, except share amounts)
Common Stock
Additional
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance, January 1, 2021
17,532,893
$ 18
$ 292,275
$ ( 230,974 )
$ 61,319
Stock-based compensation
-
-
376
-
376
Sale of common stock, net of costs
1,712,745
1
14,360
-
14,361
Net loss
-
-
-
( 5,320 )
( 5,320 )
Balance, March 31, 2021
19,245,638
$ 19
$ 307,011
$ ( 236,294 )
$ 70,736
Stock-based compensation
8,705
-
459
-
459
Sale of common stock, net of issuance costs
1,835,688
2
14,317
-
14,319
Exercise of stock options
900
-
6
-
6
Net loss
-
-
-
( 5,021 )
( 5,021 )
Balance, June 30, 2021
21,090,931
$ 21
$ 321,793
$ ( 241,315 )
$ 80,499
See
accompanying notes to the condensed consolidated financial statements.
5
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
(In
thousands)
For the
Six Months Ended
June 30,
2022
2021
Cash Flows From Operating Activities:
Net loss
$ ( 12,896 )
$ ( 10,341 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
846
835
Depreciation
317
254
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 47 )
106
Payment of security deposit
( 299 )
-
Accounts payable and accrued expenses
232
( 913 )
Other revenue deferred– current liability
( 794 )
-
Long-term license revenue deferred
35,000
-
Operating lease liabilities
( 222 )
( 167 )
Net Cash Provided By/Used In Operating Activities
22,137
( 10,226 )
Cash Flows Used In Investing Activities:
Purchase of property and equipment
( 277 )
( 65 )
Net Cash Used In Investing Activities
( 277 )
( 65 )
Cash Flows From Financing Activities:
Payments on finance leases
( 45 )
( 42 )
Sales of shares of common stock, net of costs
16,686
28,680
Proceeds from exercise of stock options
-
6
Net Cash Provided By Financing Activities
16,641
28,644
Net change in cash, cash equivalents, and restricted cash
38,501
18,353
Cash, cash equivalents, and restricted cash at beginning of period
78,221
63,999
Cash, cash equivalents, and restricted cash at end of period
$ 116,722
$ 82,352
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. (the “Company” or “Actinium”) is a clinical-stage, biopharmaceutical company focused on
developing and potentially commercializing targeted radiotherapies for patients with unmet needs. The Company applies its proprietary
technology platform consisting of over 195 patents and patent applications, know-how and clinical experience in approximately 600 patients
to develop novel therapies for blood cancer and solid tumor indications. Its clinical and preclinical development programs utilize multiple
isotopes including Actinium-225, Iodine-131 and Lutetium-177 directed at multiple validated cancer targets including CD45, CD33, CD38,
CD47, HER2 and HER3 for targeted conditioning prior to cell and gene therapies including bone marrow transplant and cancer therapeutics
as single agents or in combination with other therapeutic modalities.
Basis
of Presentation - The accompanying unaudited 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 condensed financial
information, and pursuant to 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 condensed consolidated financial statements 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 condensed
periods presented. Condensed results are not necessarily indicative of the results for the full year. These unaudited 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, 2021.
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, 2021. 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 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.
Impact
of COVID–19 Pandemic on Financial Statements - The global health crisis caused by the novel coronavirus (“COVID-19”)
pandemic and its resurgences has and may continue to negatively impact global economic activity, which, despite progress in vaccination
efforts, remains uncertain and cannot be predicted with confidence. In addition, the Omicron variants of COVID-19, including subvariants
BA.4 and BA.5, which appear to be the most transmissible variants to date, have spread globally. The full impact of the Omicron variants,
or any subsequent variants, cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among
the population, the effectiveness of COVID-19 vaccines against the Omicron variants and subsequent variants and the response by governmental
bodies and regulators.
Many
countries around the world have continued to impose quarantines and restrictions on travel and mass gatherings to slow the spread of
the virus. Accordingly, the Company’s ability to continue to operate its business may also be limited. Such events may result in
a period of business, supply and drug product manufacturing disruption, and in reduced operations, any of which could materially affect
the Company’s business, financial condition and results of operations. In response to COVID-19, the Company implemented hybrid
working for its office-based staff, while its research staff has been actively working in its laboratory throughout the pandemic and
thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development, preclinical
research or drug production of its drug candidates. A continuation or worsening of the levels of market disruption and volatility
seen in the recent past could have an adverse effect on the Company’s ability to access capital, which could in the future negatively
affect the Company’s liquidity. In addition, a recession or market correction resulting from the spread of COVID-19 could materially
affect the Company’s business and the value of the Company’s common stock.
7
Additionally,
COVID-19 may result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions
with IRB’s or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors
due to limitations in employee resources or forced furlough of government employees.
To
date, COVID-19 has not had a financial impact on the Company. The Company continues to monitor the impacts of COVID-19 on the global
economy and on its business operations. However, at this time, it is difficult to predict how long the potential operational impacts
of COVID-19 will last or to what degree further disruption might impact the Company’s operations and financial results.
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 June 30, 2022 and December 31, 2021:
(in thousands)
June 30,
2022
December 31,
2021
Cash and cash equivalents
$ 116,330
$ 77,829
Restricted cash
392
392
Cash, cash equivalents and restricted cash
$ 116,772
$ 78,221
Restricted
cash relates to a certificate of deposit held as collateral for a letter of credit issued in connection with the Company’s lease
for corporate office space.
Leases
– The Company has operating and finance leases for corporate office space, office equipment and furniture 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. The Company entered into a lease for corporate office space effective June
1, 2022 and paid a security deposit to the landlord. A certificate of deposit will be provided as collateral for a letter of credit to
be issued with this new office space during 2022 and at that time, the security deposit will be returned to the Company.
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).
8
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 and comprehensive loss 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 and comprehensive loss 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 provides for payments for
reimbursed costs, which includes overhead and general and administrative costs as well as an administrative fee. The Company recognizes
revenue from grants as it performs services and all conditions are met 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.
9
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 June 30, 2022 and 2021, the Company’s potentially dilutive shares, which include outstanding common stock
options 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)
June 30,
2022
June 30,
2021
Options
1,431
859
Warrants
2,053
2,114
Total
3,484
2,973
Recently
Adopted Accounting Pronouncements – 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.
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.
10
Recently
Issued Accounting Pronouncements – 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.
Early adoption is permitted, including adoption in an interim period. 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.
Note
3 - Leases
The Company entered into a
lease for corporate office space, effective June 1, 2022. As of June 30, 2022, the Company has two operating leases for corporate office
space and two finance leases for office equipment and furniture located in one of the corporate office spaces. In addition, the Company
has auxiliary corporate office space that it rents on a month-to-month basis; this rental is accounted for as an operating lease with
the same term as the Company’s main office.
The
components of lease expense are as follows:
Three months ended
Six months ended
(in thousands)
June 30,
2022
June 30,
2021
June 30,
2022
June 30,
2021
Operating lease expense
$ 141
$ 93
$ 234
$ 186
Finance lease cost
Amortization of right-to-use assets
$ 20
$ 21
$ 41
$ 41
Interest on lease liabilities
$ 1
$ 2
$ 2
$ 5
Total finance lease cost
$ 21
$ 23
$ 43
$ 46
Supplemental
cash flow information related to leases are as follows:
Cash
flow information:
Six months ended
(in thousands)
June 30,
2022
June 30,
2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 239
$ 188
Operating cash flow use from finance leases
$ 2
$ 5
Financing cash flow use from finance leases
$ 45
$ 42
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 2,605
$ -
Finance Leases
$ -
$ -
11
Weighted
average remaining lease terms are as follows at June 30, 2022:
Weighted average remaining lease term:
Operating leases
5.0 years
Finance Leases
0.5 year
As
the interest rate implicit in the leases was not readily determinable at the time that the leases were evaluated, the Company used its
incremental borrowing rate based on the information available in determining the present value of lease payments. The Company’s
incremental borrowing rate was based on the term of the lease, the economic environment of the lease and 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
8.0 %
Maturities
of lease liabilities are as follows:
(in thousands)
Year ending December 31,
Operating
Leases
Finance
Leases
2022 (excluding six months ended June 30, 2022)
$ 113
$ 17
2023
606
5
2024
618
-
2025
630
-
2026
643
-
2027
380
-
Total lease payments
$ 2,990
$ 22
Less imputed interest
( 363 )
( 1 )
Present value of lease liabilities
$ 2,627
$ 21
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. Other revenue recognized during the three months and six months ended June 30, 2022 was $ 0.0 million
and $ 0.9 million, respectively, and for the three months and six months ended June 30, 2021 was $ 0.3 million and $ 0.9 million, respectively.
The
Company has a grant from a government-sponsored entity for research and development related activities that provide for payments for
reimbursed costs, which includes overhead and general and administrative costs as well as an administrative fee. The Company recognizes
revenue from grants as it performs services under this arrangement. Associated expenses are recognized when incurred as research and
development expense. Other revenue recognized during the three months and six months ended June 30, 2022 was $ 0.0 million and $ 0.1 million,
respectively. There was no other revenue recognized from a grant from a government-sponsored entity during the six months ended June
30, 2021.
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. Other revenue deferred – current liability was $ 0.2 million at June 30, 2022
and $ 0.9 million at December 31, 2021. Long-term license revenue deferred was $ 35.0 million at June 30, 2022; there was no long-term license
revenue deferred at December 31, 2021. This deferred revenue will be recognized upon EU 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.
As of December 31, 2021, the Company had sold 6.7 million shares of common stock, resulting in gross proceeds of $ 59.1 million and net
proceeds of $ 57.0 million. For the six months ended June 30, 2022, the Company sold 2.7 million shares of common stock, resulting in
gross proceeds of $ 17.2 million and net proceeds of $ 16.7 million. For the six months ended June 30, 2021, the Company sold 3.5 million
shares of common stock, resulting in gross proceeds of $ 29.6 million and net proceeds of $ 28.7 million.
On
June 28, 2022, the Company entered into an Amendment 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.
13
Stock
Options
The
following is a summary of stock option activity for the six months ended June 30, 2022:
(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, 2022
1,362
$ 12.45
8.69
$ -
Granted
120
5.23
Cancelled
( 51 )
8.89
Outstanding, June 30, 2022
1,431
11.97
8.36
-
Exercisable, June 30, 2022
473
22.19
7.07
-
During
the six months ended June 30, 2022, the Company granted new employees options to purchase 120 thousand shares of common stock with an
exercise price ranging from $ 5.20 to $ 5.93 per share, a term of 10 years, and a vesting period of 4 years. The options have an aggregated
fair value of $ 442 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 1.52% to 3.03% (2) expected life of 6 years, (3) expected volatility range from 78.8% to
79.9%, 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 June 30, 2022 was $ 4.4 million related to unvested options, which is expected to be expensed over a weighted average of 3.0
years. During the six months ended June 30, 2022 and 2021, the Company recorded compensation expense related to stock options of $ 0.8
million and $ 0.7 million, respectively.
Warrants
Following
is a summary of warrant activity for the six months ended June 30, 2022:
(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, 2022
2,112
$ 20.52
1.76
$ 276
Granted
-
-
Exercised
-
-
Cancelled/Expired
( 59 )
3.62
Outstanding, June 30, 2022
2,053
$ 21.01
1.32
$ -
Exercisable, June 30, 2022
2,049
$ 20.57
1.31
$ -
Note
6 – Subsequent Event
Since
June 30, 2022, the Company has sold 0.3 million shares of common stock under its A&R Sales Agreement, resulting in net proceeds of
$ 1.4 million.
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 its common stock and warrants to purchase an aggregate
of 0.6 million shares of its 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. As of August 12, 2022, the Company has 1.4 million 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.