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 September 30, 2022 and December 31, 2021, and
the results of operations and cash flows for the three and nine months ended September 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 nine months
ended September 30, 2022 are not necessarily indicative of the operating results for the full year.
1
Actinium Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(amounts in thousands, except share and per share
data)
September 30,
2022
December 31,
2021
(Unaudited)
(Audited)
Assets
Current Assets:
Cash and cash equivalents
$ 111,815
$ 77,829
Restricted cash - current
394
392
Security deposit
-
50
Prepaid expenses and other current assets
1,214
1,478
Total Current Assets
113,423
79,749
Property and equipment, net of accumulated depreciation of $ 440 and $ 335
635
340
Restricted cash – long term
300
-
Operating leases right-of-use assets
2,454
241
Finance leases right-of-use assets
4
58
Total Assets
$ 116,816
$ 80,388
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 7,869
$ 5,535
Other revenue deferred– current liability
91
998
Operating leases current liability
386
245
Finance leases current liability
4
62
Total Current Liabilities
8,350
6,840
Long-term license revenue deferred
35,000
-
Long-term operating leases obligations
2,210
-
Long-term finance leases obligations
1
3
Total Liabilities
$ 45,561
$ 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; 25,212,072 and 22,143,974 shares issued and outstanding, respectively
25
22
Additional paid-in capital
349,348
329,271
Accumulated deficit
( 278,118 )
( 255,748 )
Total Stockholders’ Equity
71,255
73,545
Total Liabilities and Stockholders’ Equity
$ 116,816
$ 80,388
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
September 30,
For the
Nine Months Ended
September 30,
2022
2021
2022
2021
Revenue
Revenue
$ -
$ -
$ -
$ -
Other revenue
45
233
1,030
1,121
Total revenue
45
233
1,030
1,121
Operating expenses:
Research and development, net of reimbursements
6,771
4,708
15,802
12,615
General and administrative
3,073
1,994
8,041
5,422
Total operating expenses
9,844
6,702
23,843
18,037
Loss from operations
( 9,799 )
( 6,469 )
( 22,813 )
( 16,916 )
Other income:
Interest income - net
325
46
443
152
Total other income
325
46
443
152
Net loss
$ ( 9,474 )
$ ( 6,423 )
$ ( 22,370 )
$ ( 16,764 )
Net loss per common share – basic and diluted
$ ( 0.38 )
$ ( 0.30 )
$ ( 0.94 )
$ ( 0.84 )
Weighted average common shares outstanding – basic and diluted
25,164,599
21,539,455
23,691,218
20,060,315
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 Nine Months Ended September
30, 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
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
Stock-based compensation
19,639
-
970
-
970
Sale of common stock, net of issuance costs
321,810
-
1,578
-
1,578
Net loss
-
-
-
( 9,474 )
( 9,474 )
Balance, September 30, 2022
25,212,072
$ 25
$ 349,348
$ ( 278,118 )
$ 71,255
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 Nine Months Ended September
30, 2021
(Unaudited)
(amounts 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
Stock-based compensation
12,601
-
412
-
412
Sale of common stock, net of issuance costs
927,306
1
5,796
-
5,797
Net loss
-
-
-
( 6,423 )
( 6,423 )
Balance, September 30, 2021
22,030,838
$ 22
$ 328,001
$ ( 247,738 )
$ 80,285
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
Nine Months Ended
September 30,
2022
2021
Cash Flows From Operating Activities:
Net loss
$ ( 22,370 )
$ ( 16,764 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
1,816
1,246
Depreciation and amortization expense
538
387
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
264
137
Accounts payable and accrued expenses
2,334
( 566 )
Other revenue deferred– current liability
( 907 )
-
Long-term license revenue deferred
35,000
-
Operating lease liabilities
( 253 )
( 254 )
Net Cash Provided By/Used In Operating Activities
16,422
( 15,814 )
Cash Flows Used In Investing Activities:
Purchase of property and equipment
( 350 )
( 133 )
Net Cash Used In Investing Activities
( 350 )
( 133 )
Cash Flows From Financing Activities:
Payments on finance leases
( 48 )
( 63 )
Sales of shares of common stock, net of costs
18,264
34,477
Proceeds from exercise of stock options
-
6
Net Cash Provided By Financing Activities
18,216
34,420
Net change in cash, cash equivalents, and restricted cash
34,288
18,473
Cash, cash equivalents, and restricted cash at beginning of period
78,221
63,999
Cash, cash equivalents, and restricted cash at end of period
$ 112,509
$ 82,472
Supplemental disclosure of cash flow information:
Cash paid for interest
$ -
$ -
Cash paid for income taxes
$ -
$ -
Supplemental disclosure of non-cash investing and financing activity:
Acquisition of equipment financed by security deposit
$ 50
$ -
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, 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. Its lead drug candidate, Iomab-B, has met the primary endpoint of the pivotal Phase 3 SIERRA Trial
with a high degree of statistical significance (p<0.0001) and the Company will report additional data from the SIERRA trial by the
end of 2022. Its second most advanced drug candidate, Actimab-A, is being studied in a Phase 1 combination trial with the chemotherapy
regimen CLAG-M and has reported median overall survival of 12 months, 53 % 1-year overall survival and 32 % 2-year overall survival in patients
with relapsed or refractory AML who have adverse cytogenetics such as a TP53 mutation or have failed targeted therapies. Data from this
trial will be presented in an oral presentation at the American Society of Hematology Annual Meeting & Symposium in December 2022.
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 and boosters 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 manufacturing of its drug candidates. Although the Company is adhering to health and safety protocols,
an outbreak of COVID-19 at the Company’s facilities could nonetheless cause shutdowns of facilities and a reduction in its
workforce, which could cause a disruption or delay in such operations. 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 direct 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 September 30, 2022 and December 31, 2021:
(amounts in thousands)
September 30,
2022
December 31,
2021
Cash and cash equivalents
$ 111,815
$ 77,829
Restricted cash - current
394
392
Restricted cash – long-term
300
-
Cash, cash equivalents and restricted cash
$ 112,509
$ 78,221
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, 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 was provided as collateral for a letter of credit issued with this office
space during 2022 and at that time, the security deposit was 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 and nine months ended
September 30, 2022 and 2021, 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.
(amounts in thousands)
September 30,
2022
September 30,
2021
Options
3,192
1,426
Restricted Stock Units
300
-
Warrants
1,443
2,114
Total
4,935
3,540
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.
10
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.
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. The lease has a term of 5 years 2 months , with an expiration date of July 30, 2027 , and a current annual rate of $ 0.6 million.
The Company is also responsible for certain other costs, such as insurance, utilities and maintenance. As of September 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
Nine Months ended
(amounts in thousands)
September 30,
2022
September 30,
2021
September 30,
2022
September 30,
2021
Operating lease expense
$ 206
$ 93
$ 440
$ 279
Finance lease cost
Amortization of right-to-use assets
$ 14
$ 20
$ 54
$ 61
Interest on lease liabilities
$ -
$ 2
$ 2
$ 7
Total finance lease cost
$ 14
$ 22
$ 56
$ 68
11
Supplemental cash flow information
related to leases are as follows:
Cash flow information:
Nine Months ended
(amounts in thousands)
September 30,
2022
September 30,
2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 302
$ 282
Operating cash flow use from finance leases
$ 2
$ 7
Financing cash flow use from finance leases
$ 48
$ 63
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ 2,605
$ -
Finance Leases
$ -
$ -
Weighted average remaining lease terms are as follows
at September 30, 2022:
Weighted average remaining lease term:
Operating leases
4.8 years
Finance Leases
1.3 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:
(amounts in thousands)
Year ending December 31,
Operating
Leases
Finance
Leases
2022 (excluding nine months ended September 30, 2022)
$ 50
$ 1
2023
606
4
2024
618
-
2025
630
-
2026
643
-
2027
380
-
Total lease payments
$ 2,927
$ 5
Less imputed interest
( 331 )
-
Present value of lease liabilities
$ 2,596
$ 5
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 nine months ended September 30, 2022 was $ 0.0 million and $ 0.9 million,
respectively, and for the three months and nine months ended September 30, 2021 was $ 0.0 million and $ 0.9 million, respectively.
12
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 nine months ended September 30, 2022 was $ 0.0 million and $ 0.1 million, respectively. Other revenue recognized
during the three and nine months ended September 30, 2021 was $ 0.2 million.
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 $ 0.1 million at
September 30, 2022 and $ 0.9 million at December 31, 2021. Long-term license revenue deferred was $ 35.0 million at September 30, 2022;
there was no long-term license revenue deferred at December 31, 2021. 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. 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 nine months ended September 30, 2022, the Company sold 3.0 million shares of common stock, resulting in gross proceeds
of $ 18.9 million and net proceeds of $ 18.3 million. For the nine months ended September 30, 2021, the Company sold 4.5 million shares
of common stock, resulting in gross proceeds of $ 35.6 million and net proceeds of $ 34.5 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 nine months ended September 30, 2022:
(amounts 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
1,885
4.99
Cancelled
( 55 )
11.06
Outstanding, September 30, 2022
3,192
8.06
9.03
5,377
Exercisable, September 30, 2022
638
17.94
7.43
397
During the nine months ended
September 30, 2022, the Company granted options to purchase 1.9 million shares of common stock with an exercise price ranging from $ 4.96
to $ 8.46 per share, a term of 10 years, and a vesting period of 4 years. The options have an aggregated fair value of $ 6.6 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 1.52% to 3.45% (2) expected life of 6 years, (3) expected volatility range from 78.8% to 80.2%, 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 September 30,
2022 was $ 9.7 million related to unvested options, which is expected to be expensed over a weighted average of 3.5 years. During the nine
months ended September 30, 2022 and 2021, the Company recorded compensation expense related to stock options of $ 1.6 million and $ 1.0
million, respectively.
Restricted Stock Units
The Company issued 300 thousand
restricted stock units (“RSUs”) in August 2022 to an employee. These RSUs were immediately vested on the date of the grant,
however, shares under the RSUs will not be issued until the earlier 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, or the third anniversary of the date of the grant. The fair
value of the RSUs, $ 1.8 million, was determined based on the stock price of $ 5.85 on the date of the grant and is being recognized over
three years . The unrecognized compensation expense at September 30, 2022 of $ 1.7 million is expected to be expensed over 2.9 years. During
the three months and nine months ended September 30, 2022, the Company recorded compensation expense related to RSUs of $ 0.1 million.
Warrants
Following is a summary of
warrant activity for the nine months ended September 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
( 669 )
29.01
Outstanding, September 30, 2022
1,443
$ 16.58
1.58
$ -
Exercisable, September 30, 2022
1,440
$ 15.95
1.58
$ -
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.
Note 6 – Subsequent Event
Since September 30, 2022, the
Company has sold 0.3 million shares of common stock under its A&R Sales Agreement, resulting in net proceeds of $ 2.7 million.
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.