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, 2021
and December 31, 2020, and the results of operations and cash flows for the three and nine months ended September 30, 2021 and 2020,
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, 2020 in the Company’s Annual Report on Form 10-K. The results of operations for the
three and nine months ended September 30, 2021 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,
2021
December 31,
2020
(Unaudited)
Assets
Current Assets:
Cash and cash equivalents
$ 82,032
$ 63,560
Restricted cash – current
48
48
Prepaid expenses and other current assets
1,181
1,317
Total Current Assets
83,261
64,925
Property and equipment, net of accumulated depreciation of $ 367 and $ 291
369
312
Operating leases right-of-use assets
328
579
Finance leases right-of-use assets
79
140
Security deposit
50
50
Restricted cash
392
391
Total Assets
$ 84,479
$ 66,397
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 3,773
$ 4,340
Operating leases current liability
333
342
Finance leases current liability
84
85
Total Current Liabilities
4,190
4,767
Long-term operating leases obligations
-
245
Long-term finance leases obligations
4
66
Total Liabilities
4,194
5,078
Commitments and contingencies (Note 2)
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; 22,030,838 and 17,532,893 shares issued and outstanding, respectively
22
18
Additional paid-in capital
328,001
292,275
Accumulated deficit
( 247,738 )
( 230,974 )
Total Stockholders’ Equity
80,285
61,319
Total Liabilities and Stockholders’ Equity
$ 84,479
$ 66,397
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,
2021
2020
2021
2020
Revenue
Revenue
$ -
$ -
$ -
$ -
Other revenue
233
-
1,121
-
Total revenue
233
-
1,121
-
Operating expenses:
Research and development, net of reimbursements
4,708
3,788
12,615
11,446
General and administrative
1,994
1,825
5,422
4,512
Total operating expenses
6,702
5,613
18,037
15,958
Loss from operations
( 6,469 )
( 5,613 )
( 16,916 )
( 15,958 )
Other income:
Interest income - net
46
73
152
123
Total other income
46
73
152
123
Net loss
$ ( 6,423 )
$ ( 5,540 )
$ ( 16,764 )
$ ( 15,835 )
Deemed dividend for warrant down-round protection
provision
-
-
-
( 1 )
Net loss applicable to common stockholders
$ ( 6,423 )
$ ( 5,540 )
$ ( 16,764 )
$ ( 15,836 )
Net loss per share of common stock – basic and diluted
$ ( 0.30 )
$ ( 0.36 )
$ ( 0.84 )
$ ( 1.46 )
Weighted average shares of common stock outstanding,
including outstanding pre-funded warrants– basic and
diluted
21,539,455
15,432,857
20,060,315
10,875,712
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, 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 costs
1,835,688
2
14,317
-
14,319
Issuance of shares from 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 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.
4
Actinium
Pharmaceuticals, Inc.
Condensed
Consolidated Statement of Changes in Stockholders’ Equity
For
the Three and Nine months Ended September 30, 2020
(Unaudited)
(amounts
in thousands, except share amounts)
Common Stock
Additional
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance, January 1, 2020
5,490,038
$
5
$
214,397
$
( 208,758
)
$
5,644
Stock-based compensation
-
-
372
-
372
Sale of common stock, net of costs
337,944
1
2,673
-
2,674
Net loss
-
-
-
( 5,670
)
( 5,670
)
Balance, March 31, 2020
5,827,982
$
6
$
217,442
$
( 214,428
)
$
3,020
Stock-based compensation
5,240
-
210
-
210
Issuance of common stock from exercise of pre-funded warrants
1,200,000
1
3
-
4
Sale of common stock and pre-funded
warrants, net of costs
6,138,602
6
52,159
-
52,165
Deemed dividend for warrant down-round protection provision
-
-
1
( 1
)
-
Net loss
-
-
-
( 4,625
)
( 4,625
)
Balance, June 30, 2020
13,171,824
$
13
$
269,815
$
( 219,054
)
$
50,774
Stock-based compensation
1,023
-
288
-
288
Issuance of common stock from exercise of warrants and stock options
2,609
-
37
-
37
Issuance of common stock from exercise of pre-funded warrants
411,069
1
1
-
2
Costs related to prospectus filed on Form S-3
-
-
( 134
)
-
( 134
)
Net loss
-
-
-
( 5,540
)
( 5,540
)
Balance, September 30, 2020
13,586,525
$
14
$
270,007
$
( 224,594
)
$
45,427
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,
2021
2020
Cash Flows From Operating Activities:
Net loss
$ ( 16,764 )
$ ( 15,835 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense
1,246
870
Depreciation & amortization expenses
387
327
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
137
( 112 )
Accounts payable and accrued expenses
( 566 )
( 375 )
Operating lease liabilities
( 254 )
( 234 )
Net Cash Used In Operating Activities
( 15,814 )
( 15,359 )
Cash Flows Used In Investing Activities:
Purchase of property and equipment
( 133 )
( 8 )
Net Cash Used In Investing Activities
( 133 )
( 8 )
Cash Flows From Financing Activities:
Payments on note payable
-
( 343 )
Payments on finance leases
( 63 )
( 58 )
Sales of shares of common stock and pre-funded warrants, net of costs
-
54,705
Sales of shares of common stock, net of costs
34,477
-
Proceeds from exercise of stock options
6
6
Proceeds from exercise of pre-funded warrants
-
37
Net Cash Provided By Financing Activities
34,420
54,347
Net change in cash, cash equivalents, and restricted cash
18,473
38,980
Cash, cash equivalents, and restricted cash at beginning of period
63,999
9,693
Cash, cash equivalents, and restricted cash at end of period
$ 82,472
$ 48,673
Supplemental disclosure of cash flow information:
Cash paid for interest on note payable
$ -
$ 7
Cash paid for taxes
$ -
$ -
Supplemental disclosure of non-cash flow information:
Deemed dividend for warrant down-round protection provision
$ -
$ 1
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”, “Actinium”, or “We”) is a clinical-stage,
biopharmaceutical company applying its proprietary platform technology and deep understanding of radiobiology to the development of
novel targeted therapies known as ARCs or Antibody Radiation-Conjugates. Radiation is an effective therapeutic modality that is used
in the treatment of over fifty percent of all cancer patients and often combined with chemotherapy and immunotherapy for greater
therapeutic effect. ARCs combine the cell-killing ability of a radioisotope payload with a targeting agent, such as a monoclonal
antibody, or mAb, to deliver radiation inside the body to specific cells, to potentially generate greater efficacy and less
toxicity. ARCs usage is broader than externally delivered radiation as they can be used for both solid tumors and blood cancers.
Blood or hematologic cancers are highly sensitive to radiation and our clinical pipeline is focused on ARCs targeting the antigens
CD45 and CD33, both of which are expressed in multiple hematologic cancers. The Company’s clinical programs are focused on two
primary areas: targeted conditioning prior to bone marrow transplant, adoptive cell or gene therapies and therapeutics, in
combination with other therapeutic modalities. The Company’s product development strategy is actively informed by clinical
data with its ARCs in approximately 600 patients, including the pivotal Phase 3 SIERRA trial for the Company’s lead asset
Iomab-B, which completed enrollment of 150 patients in September 2021. The clinical pipeline has emanated from its Antibody Warhead
Enabling (“AWE”) technology platform, which is protected by over 160 issued patents and pending patent applications,
trade secrets and know-how and is being utilized in a collaborative research partnership with Astellas Pharma, Inc.,
(“Astellas”). The AWE technology platform is also being used to advance Actinium’s research objectives focused on
developing next-generation targeted radiotherapies.
Basis
of Presentation - Unaudited Interim Financial Information - The accompanying unaudited interim 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 consolidated 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 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, 2020.
Principles
of Consolidation - The consolidated financial statements include the Company’s accounts and those of the Company’s wholly
owned subsidiaries.
Use
of Estimates in Financial Statement Presentation - The preparation of these 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 Delta variant
of COVID-19, which appears to be the most transmissible variant to date, has spread globally. The full impact of the Delta variant
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 Delta variant and the response by governmental bodies and regulators.
7
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 remote
working and thus far, has not experienced a significant disruption or delay in its operations as it relates to the clinical development
or drug production of our 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.
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 September 30, 2021 and December 31, 2020:
(in thousands)
September 30,
2021
December 31,
2020
Cash and cash equivalents
$ 82,032
$ 63,560
Restricted cash – current
48
48
Restricted cash – long-term
392
391
Cash, cash equivalents and restricted cash
$ 82,472
$ 63,999
Current
restricted cash relates to credit card accounts, while long-term 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. See Note 3 for additional information.
Fair
Value of Financial Instruments - Fair value is defined as the price that would be received to sell an asset, or paid to transfer
a liability, in an orderly transaction between market participants. A fair value hierarchy has been established for valuation inputs
that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable
inputs.
Revenue
Recognition - The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue From
Contracts With Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when its customer obtains control of
promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods
or services. To determine revenue recognition for arrangements within the scope of ASC 606, the entity performs the following five steps:
(i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction
price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract;
and (v) recognize revenue as the entity satisfies a performance obligation. The Company only applies the five-step model to contracts
when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers
to the customer.
8
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 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 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. Revenue and related expenses are presented gross in the consolidated statements of operations.
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 income, and when the effects
are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common stockholders by the weighted-average
number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common shares underlying
common stock options and warrants using the treasury stock method. The Company issued pre-funded warrants in April 2020 and June 2020
that were considered outstanding shares for the purposes of calculating net loss per common share for the three months and nine months
ended September 30, 2020, see Note 5 for additional information. As of December 31, 2020, all of the pre-funded warrants were exercised
and there were no pre-funded warrants outstanding during the nine months ended September 30, 2021.
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 and nine months ended September 30, 2021 and 2020, 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. As of September 30, 2021 and 2020, outstanding options and warrants are as
follows:
(in thousands)
September 30,
2021
September 30,
2020
Options
1,426
750
Warrants
2,114
2,113
Total
3,540
2,863
Accounting
Standards Recently Adopted - In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic
470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity , which, among other things, provides guidance on how to account for contracts on an
entity’s own equity. This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and
equity. Specifically, the ASU eliminated the need for the Company to assess whether a contract on the entity’s own equity (1) permits
settlement in unregistered shares, (2) whether counterparty rights rank higher than shareholder’s rights, and (3) whether collateral
is required. In addition, the ASU requires incremental disclosure related to contracts on the entity’s own equity and clarifies
the treatment of certain financial instruments accounted for under this ASU on earnings per share. This ASU may be applied on a full
retrospective of modified retrospective basis. This ASU is effective January 1, 2022 and interim periods presented, although early adoption
of this ASU was permitted effective January 1, 2021. The Company early adopted this standard effective January 1, 2021 and the standard
did not have a significant impact on the Company’s financial statements.
Accounting
Standards Recently Issued - 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. Early adoption is permitted. The Company will apply the amendments prospectively
to modifications or exchanges occurring on or after January 1, 2022. The Company will evaluate the impact of ASU 2017-09 on any future
changes to the terms and conditions of its warrants.
10
Note
2 - Commitments and Contingencies
Agreements
The
Company has entered into agreements with third parties for the rights to certain intellectual property, manufacturing and clinical trial
services under which the Company may incur obligations to make payments including upfront payments as well as milestone and royalty payments.
A notable inclusion in this category is:
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 BC8 (licensed antibody), currently known as apamistamab. FHCRC has completed both a Phase 1 and Phase
2 clinical trial with apamistamab. The Company has been granted exclusive rights to the apamistamab antibody and related master cell bank developed by
FHCRC. A milestone payment of $ 1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed apamistamab
antibody. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.
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.
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 is not readily determinable in the Company’s leases, the
incremental borrowing rate is used based on the information available at commencement date in determining the present value of lease
payments.
The
lease term for all of the Company’s leases includes the non-cancellable period of the lease plus any additional periods covered
by either a Company option to extend (or not to terminate) the lease that the Company is reasonably certain to exercise, or an option
to extend (or not to terminate) the lease controlled by the lessor. Options for lease renewals have been excluded from the lease term
(and lease liability) for the majority of the Company’s leases as the reasonably certain threshold is not met.
At
September 30, 2021, the Company has an operating lease for corporate office space and two finance leases for office equipment and furniture
located in the corporate office space. 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 in the same building.
The
components of lease expense are as follows:
Three months ended
Nine months ended
(in thousands)
September 30,
2021
September 30,
2020
September 30,
2021
September 30,
2020
Operating lease expense
$ 93
$ 93
$ 279
$ 279
Finance lease cost
Amortization of right-to-use assets
$ 20
$ 20
$ 61
$ 61
Interest on lease liabilities
$ 2
$ 4
$ 7
$ 12
Total finance lease cost
$ 22
$ 24
$ 68
$ 73
11
Supplemental
cash flow information related to leases are as follows:
Cash
flow information:
Nine months ended
(in thousands)
September 30,
2021
September 30,
2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases
$ 282
$ 281
Operating cash flow use from finance leases
$ 7
$ 12
Financing cash flow use from finance leases
$ 63
$ 58
Non-cash activity:
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ 83
Finance Leases
$ -
$ -
Weighted
average remaining lease terms are as follows at September 30, 2021:
Weighted average remaining lease term:
Operating leases
1.0 year
Finance Leases
0.9 year
As
the rate implicit in the leases was not readily determinable, 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
8 %
Finance Leases
8 %
Maturities
of lease liabilities are as follows:
(in thousands)
Year ending December 31,
Operating
Leases
Finance
Leases
2021 (excluding nine months ended September 30, 2021)
$ 94
$ 24
2022
252
64
2023
-
4
Total lease payments
$ 346
$ 92
Less imputed interest
( 13 )
( 4 )
Present value of lease liabilities
$ 333
$ 88
Note
4 - Other revenue
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. Revenue of $ 0.2 million was recognized during the three and nine months ended September 30, 2021.
12
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 to revenue over each module and revenue recognized during the nine months
ended September 30, 2021 was $ 0.9 million.
Note
5 - Equity
In August 2020, the Company entered
into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”), pursuant
to which the Company may sell, from time to time, through or to JonesTrading, up to an aggregate of $ 200 million of its common stock.
Shares of common stock are offered pursuant to the Company’s shelf registration statement on Form S-3 filed with the SEC on August
7, 2020. As of December 31, 2020, the Company had sold 2.1 million shares of common stock, resulting in gross proceeds of $ 22.6 million
and net proceeds of $ 21.7 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
April 24, 2020, the Company issued and sold 4.3 million shares of common stock and 2.8 million pre-funded warrants to purchase shares
of common stock. The price to the public in this offering for each share of common stock was $ 4.50 and for each pre-funded warrant was
$ 4.497 . Each pre-funded warrant had an exercise price of $ 0.003 per share and was exercisable immediately upon issuance. Gross proceeds
from this offering were $ 31.6 million, before deducting underwriting discounts and commissions and other offering expenses payable by
the Company. Net proceeds from this offering were $ 29.1 million.
During
the nine months ended September 30, 2020, holders of 1.4 million pre-funded April 2020 warrants exercised their warrants at $ 0.003 per
share and received 1.4 million shares of common stock.
On
June 19, 2020, the Company issued and sold 1.9 million shares of common stock and 0.7 million pre-funded warrants to purchase shares
of common stock. The price to the public in this offering for each share of common stock was $ 9.75 and for each pre-funded warrant was
$ 9.747 . Each pre-funded warrant had an exercise price of $ 0.003 per share and was exercisable immediately upon issuance. Gross proceeds
from this offering were $ 25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by
the Company. Net proceeds from this offering were $ 23.0 million.
During
the nine months ended September 30, 2020, holders of 0.2 million pre-funded June 2020 warrants exercised their warrants at $ 0.003 per
share and received 0.2 million shares of common stock.
13
Stock
Options
The
following is a summary of stock option activity for the nine months ended September 30, 2021:
(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, 2021
815
$ 21.53
8.51
$ 120
Granted
880
6.43
Exercised
( 1 )
6.69
Cancelled
( 268 )
19.65
Outstanding, September 30, 2021
1,426
12.57
8.55
2,207
Exercisable, September 30, 2021
337
29.19
5.38
134
During
the nine months ended September 30, 2021, the Company granted employees options to purchase 880 thousand shares of the Company’s
common stock with an exercise price ranging from $ 6.02 to $ 9.25 per share, a term of 10 years, and a vesting period of 4 years. The options
have an aggregated fair value of $ 3.9 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 0.65% to 1.07% (2) expected life of 6 years, (3) expected volatility
range from 79.8% to 85.1%, and (4) no expected dividends. During the nine months ended September 30, 2021, options to purchase 1 thousand
shares were exercised and options to purchase 268 thousand shares were cancelled upon the termination of employment for several employees.
The
fair values of all options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation
expense at September 30, 2021 was $ 5.4 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, 2021 and 2020, the Company recorded compensation expense related to stock options
of $ 1.0 million and $ 0.8 million, respectively.
Pre-funded
Warrants
As
part of the April 2020 offering and the June 2020 offering, the Company issued pre-funded warrants. Each pre-funded warrant had an exercise
price of $ 0.003 per share and was exercisable immediately upon issuance. Management determined that the pre-funded warrants were freestanding
instruments and that the pre-funded warrants should be classified as permanent equity. As of December 31, 2020, all of the pre-funded
warrants were exercised and there were no pre-funded warrants outstanding during the nine months ended September 30, 2021. As of September
30, 2020, there were 1.8 million pre-funded warrants outstanding.
14
Warrants
Following
is a summary of warrant activity for the nine months ended September 30, 2021:
(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, 2021
2,113
$ 20.55
2.76
$ 362
Granted
1
8.30
Exercised
-
-
Cancelled/Expired
-
-
Outstanding, September 30, 2021
2,114
$ 20.54
2.01
$ 414
Exercisable, September 30, 2021
2,112
$ 20.55
2.01
$ 414
The
Company has an outstanding warrant to purchase 1,907 shares of common stock, issued on March 14, 2017 to Sandesh Seth, the Company’s
Chairman and Chief Executive Officer. The warrant included down-round protection up until it was amended on August 11, 2020. For warrants
with down-round protection, a deemed dividend is recorded for the change in fair value of the warrants when the down-round provision
is triggered. As a result of the April 2020 offering and June 2020 offering, the exercise price of the warrant was reset from $ 26.40
per share to $ 15.62 per share. The down-round protection provision in the above warrants created a deemed dividend to common stockholders
of $ 1 thousand in the nine months ended September 30, 2020 which is reflected in the accompanying consolidated statement of operations
and consolidated statement of changes in stockholders’ equity. On August 11, 2020, the Company and Mr. Seth agreed to amend the
warrant to remove the anti-dilution provision that had been in the warrant. Accordingly, pursuant to the amendment, as of August 11,
2020, the exercise price of the warrant will no longer be subject to a proportional adjustment if and when the Company issues any shares
of its common stock for a consideration less than the exercise price of the warrant. All other terms of the warrant remained the same.
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.