Item 8. Financial Statements and Supplementary Data
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
TABLE OF CONTENTS
Page
Reports of Independent Public Accounting Firm
29
Financial Statements:
Consolidated balance sheets as of June 30, 2020 and 2019
30
Consolidated statements of operations for the fiscal years ended June 30, 2020 and 2019
31
Consolidated statements of stockholders’ equity for the fiscal years ended June 30, 2020 and 2019
32
Consolidated statements of cash flows for the fiscal years ended June 30, 2020 and 2019
33
Notes to consolidated financial statements
34
28
REPORT
OF INDEPENDENT PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors
Rezolute, Inc.
OPINION ON THE FINANCIAL STATEMENTS
We have audited the accompanying consolidated
balance sheet of Rezolute, Inc. (the “Company”) as of June 30, 2020 and 2019, and the related consolidated
statements of operations, stockholders’ equity and cash flows for the years ended June 30, 2020 and 2019, and the related
notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements
referred to above present fairly, in all material respects, the financial position of the Company as of June 30, 2020 and
2019, and the results of its operations and its cash flows for the years ended June 30, 2020 and 2019, in conformity with
accounting principles generally accepted in the United States of America.
BASIS FOR OPINION
The Company's management is responsible
for these financial statements. Our responsibility is to express an opinion on the Company’s financial statements based
on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance
with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about
whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required
to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are
required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures
to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide
a reasonable basis for our opinion.
/s/ Plante & Moran, PLLC
We have served as the Company’s
auditors since 2013.
Denver, Colorado
October 13, 2020
29
REZOLUTE, INC.
Consolidated
Balance Sheets
June 30,
2020 and 2019
(In
Thousands, Except Per Share Amounts)
2020
2019
Assets
Current assets:
Cash and cash equivalents
$ 9,955
$ 11,573
Prepaid expenses and other
563
571
Total current assets
10,518
12,144
Right-of-use assets, net
383
-
Property and equipment, net
33
44
Intangible assets, net
-
29
Lease security deposits
31
35
Total assets
$ 10,965
$ 12,252
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$ 893
$ 563
Accrued liabilities:
Insurance premiums
188
-
Compensation and benefits
120
790
Other
180
526
Current portion of license fees payable to Xoma
1,600
6,500
Current portion of operating lease liabilities
245
-
Total current liabilities
3,226
8,379
License fees payable to Xoma, net of current portion
209
2,000
Operating lease liabilities, net of current portion
165
-
Other non-current liabilities
-
121
Total liabilities
3,600
10,500
Commitments and contingencies (Notes 4 and 9)
Stockholders' equity:
Preferred Stock, $0.001 par value; 20,000 shares authorized, no shares issued
-
-
Common Stock, $0.001 par value, 500,000 shares authorized;
5,867 and 4,208 shares issued and outstanding as of June 30, 2020 and 2019, respectively
6
4
Additional paid-in capital
154,595
128,651
Accumulated deficit
(147,236 )
(126,903 )
Total stockholders' equity
7,365
1,752
Total liabilities and stockholders' equity
$ 10,965
$ 12,252
The
accompanying notes are an integral part of these consolidated financial statements.
30
REZOLUTE, INC.
Consolidated
Statements of Operations
For
the Years Ended June 30, 2020 and 2019
(In
Thousands, Except Per Share Amounts)
2020
2019
Operating expenses:
Research and development:
Compensation and benefits
$ 5,883
$ 2,578
Clinical trial costs
3,955
35
Consultants and outside services
3,209
674
Material manufacturing costs
882
1,232
Facilities and other
521
534
Licensing costs
-
14,026
Total research and development
14,450
19,079
General and administrative:
Compensation and benefits
3,782
4,286
Professional fees
1,169
1,341
Facilities and other
1,120
1,238
Total general and administrative
6,071
6,865
Total operating expenses
20,521
25,944
Operating loss
(20,521 )
(25,944 )
Non-operating income (expense):
Interest and other income
188
456
Interest expense
-
(4,958 )
Total non-operating income (expense)
188
(4,502 )
Net loss
$ (20,333 )
$ (30,446 )
Net loss attributable to common stockholders
$ (20,333 )
$ (32,719 )
Net loss per common share - basic and diluted
$ (3.54 )
$ (18.41 )
Weighted average number of common shares outstanding - basic and diluted
5,751
1,777
The
accompanying notes are an integral part of these consolidated financial statements.
31
REZOLUTE, INC.
Consolidated
Statements of Stockholders’ Equity
For
the Years Ended June 30, 2020 and 2019
(In Thousands, Except Per Share Amounts)
Series AA
Additional
Total
Preferred
Stock
Common
Stock
Paid-in
Accumulated
Stockholders'
Shares
Amount
Shares
Amount
Capital
Deficit
Equity (Deficit)
Balances, June 30,
2018
-
$ -
1,243
$ 1
$ 90,222
$ (94,184 )
$ (3,961 )
Stock-based
compensation
-
-
-
-
2,636
-
2,636
Fair value of warrants:
Issued
to consultants for services
-
-
-
-
12
-
12
Modification
for debt discount to former member of Board of Directors
-
-
-
-
138
-
138
Shareholder
surrender of shares for no consideration
-
-
(6 )
-
-
-
-
Beneficial
conversion feature related to:
Fiscal
2018 Notes
-
-
-
-
2,233
-
2,233
Series AA
Preferred Stock
-
-
-
-
2,273
(2,273 )
-
Issuance
of Series AA Preferred Stock for:
Cash,
including Exclusivity Payment
2,500
25,000
-
-
-
-
25,000
Principal
under Fiscal 2018 Notes
668
5,340
-
-
-
-
5,340
Accrued
interest under Fiscal 2018 Notes
100
800
-
-
-
-
800
Conversion
of Series AA Preferred Stock to Common Stock
(3,268 )
(31,140 )
2,971
3
31,137
-
-
Net
loss
-
-
-
-
-
(30,446 )
(30,446 )
Balances,
June 30, 2019
-
-
4,208
4
128,651
(126,903 )
1,752
Stock-based
compensation
-
-
-
-
3,317
-
3,317
Fair
value of warrants issued to consultants for services
-
-
-
-
79
-
79
Issuance
of common stock for cash:
Related
parties at $14.50 per share
-
-
1,380
2
19,998
-
20,000
Other
investors at $14.50 per share
-
-
279
-
4,050
-
4,050
Advisory
fees and other offering costs
-
-
-
-
(1,500 )
-
(1,500 )
Net
loss
-
-
-
-
-
(20,333 )
(20,333 )
Balances,
June 30, 2020
-
$ -
5,867
$ 6
$ 154,595
$ (147,236 )
$ 7,365
The
accompanying notes are an integral part of these consolidated financial statements.
32
REZOLUTE, INC.
Consolidated Statements of Cash Flows
For the Years Ended June 30, 2020 and
2019
(In Thousands)
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ (20,333 )
$ (30,446 )
Stock-based compensation expense
3,317
2,636
Fair value of warrants issued for services
79
12
Impairment of long-lived assets and other
23
45
Depreciation and amortization expense
18
49
Non-cash lease expense
222
-
Beneficial conversion feature attributable to Fiscal 2018 Notes
-
2,233
Accretion of debt discount and issuance costs
-
2,053
Gain on lease termination
-
(168 )
Derivative gains
-
(74 )
Changes in operating assets and liabilities:
Decrease (increase) in prepaid expenses and other assets
12
(251 )
Increase (decrease) in accounts payable
330
(931 )
Increase (decrease) in other accrued liabilities
(1,145 )
383
Increase (decrease) in license fees payable to Xoma
(6,691 )
8,500
Increase in interest payable
-
655
Net Cash Used In Operating Activities
(24,168 )
(15,304 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of equipment
-
278
Purchase of office furniture and equipment
-
(47 )
Net Cash Provided By Investing Activities
-
231
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from investors in Series AA Financing:
Exclusivity Payment
-
1,500
Closing payment
-
23,500
Proceeds from issuance of Common Stock
24,050
-
Payment of offering costs
(1,500 )
-
Net Cash Provided by Financing Activities
22,550
25,000
Net increase (decrease) in cash, cash equivalents and restricted cash
(1,618 )
9,927
Cash, cash equivalents and restricted cash at beginning of fiscal year
11,573
1,646
Cash, cash equivalents and restricted cash at end of fiscal year
$ 9,955
$ 11,573
SUPPLEMENTARY CASH FLOW INFORMATION:
Cash paid for interest
$ -
$ -
Cash paid for income taxes
-
-
NON-CASH INVESTING AND FINANCING ACTIVITIES:
Issuance of Series AA Preferred Stock for conversion of:
Principal balance of Fiscal 2018 Notes
$ -
$ 5,340
Accrued interest under Fiscal 2018 Notes
-
800
Exclusivity Payment liability
-
1,500
Conversion of Series AA Preferred Stock to Common Stock
-
31,140
Fair value of warrant modification issued for debt discount
-
138
The
accompanying notes are an integral part of these consolidated financial statements.
33
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Note
1 — Nature of Operations and Summary of Significant Accounting Policies
Nature of Operations
Rezolute, Inc. (the “Company”) is a clinical
stage biopharmaceutical company incorporated in Delaware in 2010.
Consolidation
The
Company has three wholly owned subsidiaries consisting of AntriaBio Delaware, Inc. (“Antria Delaware”), Rezolute
(Bio) Ireland Limited, and Rezolute Bio UK, Ltd. The accompanying consolidated financial statements include the accounts of
the Company and its three wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated
in consolidation.
Reverse Stock Split
In
August 2019, the Company’s Board of Directors approved a reverse stock split that was subject to stockholder approval
at a special meeting that was concluded on October 28, 2019. Stockholders approved the proposal whereby the Board of Directors
had the ability at any time on or before October 23, 2020 to execute a reverse stock split and set an exchange ratio between
20 and 100 shares of the Company’s outstanding Common Stock, $0.001 par value per share, into one issued and outstanding
share of Common Stock, without any change in the par value per share or the number of shares of Common Stock authorized. On October 7,
2020, the Board of Directors approved a one share for 50 shares reverse stock split of
the Company’s $0.001 par value Common Stock (the “Reverse Stock Split”), resulting in the filing with the Delaware
Secretary of State of a Certificate of Amendment (the “Amendment”) to the Company’s Articles of Incorporation.
The Amendment was effective on October 9, 2020.
In connection with the Reverse Stock Split,
proportionate adjustments were made to increase the per share exercise prices and decrease the number of shares of Common Stock
issuable upon exercise of stock options and warrants whereby approximately the same aggregate price is required to be paid for
such securities upon exercise as had been payable immediately preceding the Reverse Stock Split. In addition, any fractional shares
that would otherwise be issued as a result of the Reverse Stock Split were rounded up to the nearest whole share. All references
in the accompanying consolidated financial statements to the number of shares of Common Stock and per share amounts have been retroactively
adjusted to give effect to the Reverse Stock Split.
Basis of Presentation
The Company’s consolidated financial
statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Certain amounts in the previously issued comparative financial statements for fiscal 2019 have been reclassified to conform to
the current fiscal 2020 financial statement presentation. These reclassifications had no effect on the previously reported net
loss, working capital, cash flows and stockholders’ equity.
Comprehensive income (loss) is defined
as net income (loss) plus other comprehensive income (loss). Other comprehensive income (loss) is comprised of revenues, expenses,
gains, and losses that under GAAP are reported as separate components of stockholders’ equity instead of net income (loss).
For the fiscal years ended June 30, 2020 and 2019, the only component of comprehensive loss was the Company’s net loss.
The Company’s Chief Executive Officer
also serves as the Company’s chief operating decision maker (the “CODM”) for purposes of allocating resources
and assessing performance based on financial information of the Company. Since its inception, the Company has determined that its
activities as a clinical stage biopharmaceutical company are classified as a single reportable operating segment.
Use of Estimates
The preparation of financial statements
in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the
consolidated financial statements and the accompanying notes. The Company bases its estimates and assumptions on current facts,
historical experience, and various other factors that it believes are reasonable under the circumstances, to determine the carrying
values of assets and liabilities that are not readily apparent from other sources. The Company’s significant accounting estimates
include, but are not necessarily limited to, fair value of share-based payments and warrants, management’s assessment of
going concern, clinical trial accrued liabilities, estimates of the probability and potential magnitude of contingent liabilities,
and the valuation allowance for deferred tax assets due to continuing and expected future operating losses. Actual results could
differ from those estimates.
34
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Risks and Uncertainties
The Company's operations may be subject
to significant risks and uncertainties including financial, operational, regulatory and other risks associated with a clinical
stage company, including the potential risk of business failure as discussed further in Note 2, and the future impact of COVID-19
as discussed in Note 9.
Cash and Cash Equivalents
All highly liquid investments purchased
with an original maturity of three months or less that are freely available for the Company’s immediate and general business
use are classified as cash and cash equivalents. Cash and cash equivalents consist primarily of demand deposits with financial
institutions.
Leases
The Company determines if an arrangement
includes a lease as of the date an agreement is entered into. Operating leases are included in right-of-use (“ROU”)
assets and operating lease liabilities in the Company's Consolidated Balance Sheets. ROU assets and operating lease liabilities
are initially recognized based on the present value of the future minimum lease payments at the commencement date of the lease.
The Company generally uses its incremental borrowing rate based on the information available at the lease commencement date in
determining the present value of future payments. The Company's leases may include options to extend or terminate the lease; these
options are included in the calculation of ROU assets and operating lease liabilities when it is reasonably certain that the Company
will exercise the options. Lease expense is recognized on a straight-line basis over the lease term. The Company has elected not
to apply the recognition requirements for short-term leases. For lease agreements with lease and non-lease components, the Company
generally accounts for them separately.
Property and Equipment
Property and equipment is recorded at cost less accumulated
depreciation of approximately $14,000 as of June 30, 2020 and $3,000 as of June 30, 2019. Maintenance and repairs are
expensed as incurred.
Depreciation
expense is calculated using the straight-line method over the estimated useful lives of the assets which range from 3 to 5 years.
Depreciation expense commences when assets are initially placed into service for their intended use. Depreciation expense
related to property and equipment amounted to approximately $11,000 and $41,000 for the fiscal years ended June 30, 2020 and
2019, respectively.
Intangible Assets
Intangible assets consist of patents that
were recorded at the estimated acquisition date fair value. Such costs were being amortized over 11 years which was the life of
the patents at the time they were acquired. Amortization expense related to intangible assets amounted to approximately $7,000
for each of the fiscal years ended June 30, 2020 and 2019.
Impairment of Long-lived Assets
Long-lived assets are reviewed for impairment
whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Impairment exists
for office furniture and equipment and patents if the carrying amounts of such assets exceed the estimates of future net undiscounted
cash flows expected to be generated by such assets. An impairment charge is recognized for the amount by which the carrying amount
of the asset, or asset group, exceeds its fair value. In June 2020, the Company determine that indicators of impairment existed
for the patents and recognized a charge of approximately $23,000 for the remaining net carrying value of the patents.
Debt Discounts and Issuance Costs
Debt
discounts and issuance costs (“DDIC”) incurred to obtain new debt financing or modify existing debt financing consist
of incremental direct costs incurred for professional fees and due diligence services. If convertible notes are issued in
conjunction with warrants, the Company allocates the proceeds to each component using a relative fair value. DDIC are presented
in the accompanying consolidated balance sheets as a reduction in the carrying value of the debt and are accreted to interest expense
using the effective interest method.
35
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
When debt arrangements are amended, the
revised terms are evaluated to determine if the amendment should be accounted for as a troubled debt restructuring, a modification
or an extinguishment. If the Company determines that the lender has provided a concession and the Company is experiencing financial
difficulties, treatment as a troubled debt restructuring would be required where a gain would generally be recognized. If the Company
concludes that accounting as a modification is required, then any costs incurred on behalf of the lenders are accounted for as
additional DDIC. If the Company concludes that accounting as an extinguishment is required, an extinguishment charge is measured
on the date of the amendment based on the amount by which the fair value of the new debt instrument exceeds the net carrying value
of the original debt instrument.
Beneficial Conversion Features
A beneficial conversion feature (“BCF”)
is a non-detachable conversion feature that is “in the money” at the commitment date, which requires recognition of
interest expense for underlying debt instruments and a deemed dividend for underlying equity instruments. A conversion option is
in the money if the effective conversion price is lower than the commitment date fair value of a share into which it is convertible.
A contingent BCF feature is measured using the commitment date security price but is not recognized in earnings until the contingency
is resolved.
Research and Development Costs
Research
and development costs are expensed as incurred. Intangible assets for in-licensing costs incurred under license agreements
with third parties are charged to expense, unless the licensing rights have separate economic value in alternative future research
and development projects or otherwise.
Clinical Trial Accruals
Clinical trial costs are a component of
research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based
upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established
with clinical research organizations and clinical trial sites. The Company determines the estimates through discussions with internal
clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon
fee to be paid for such services.
Nonrefundable advance payments for goods
and services that will be used or rendered in future research and development activities, are deferred and recognized as expense
in the period that the related goods are delivered, or services are performed.
Stock-Based Compensation
The Company measures the fair value of
employee and director services received in exchange for all equity awards granted, including stock options, based on the fair market
value of the award as of the grant date. The Company computes the fair value of stock options using the Black-Scholes-Merton (“BSM”)
option pricing model and recognizes the cost of the equity awards over the period that services are provided to earn the award,
usually the vesting period. For awards granted which contain a graded vesting schedule, and the only condition for vesting is a
service condition, compensation cost is recognized as an expense on a straight-line basis over the requisite service period as
if the award was, in substance, a single award. The Company recognizes the impact of forfeitures in the period that the forfeiture
occurs, rather than estimating the number of awards that are not expected to vest in accounting for stock-based compensation.
The Company has granted stock options with
vesting that is dependent on achieving certain market, performance and service conditions (“Hybrid Options”). For purposes
of recognizing compensation cost, the Company determines the requisite service period as the longest of the derived, implicit and
explicit vesting periods for each of the market, performance and service conditions, respectively. Compensation cost will be recognized
beginning on such date that achievement of the performance condition is considered probable and continuing through the end of the
requisite service period. Determination of the requisite service period of the Hybrid Options will be based on the date that the
performance condition is considered probable. Unrecognized compensation cost for the Hybrid Options, calculated using the Black-Scholes-Merton
(“BSM”) pricing model, will be recognized beginning on the date that the performance condition is considered probable
using the grant date fair value. If the Hybrid Options do not ultimately become exercisable as a result of failure to achieve the
requisite service period, any previously recognized compensation cost will be reversed.
36
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Derivatives
When the Company enters into a financial
instrument such as a debt or equity agreement (the “host contract”), the Company assesses whether the economic characteristics
of any embedded features are clearly and closely related to the primary economic characteristics of the remainder of the host contract.
When it is determined that (i) an embedded feature possesses economic characteristics that are not clearly and closely related
to the primary economic characteristics of the host contract, and (ii) a separate, stand-alone instrument with the same terms
would meet the definition of a financial derivative instrument and cannot be classified in stockholders’ equity, then the
embedded feature is bifurcated from the host contract and accounted for as a derivative instrument. The estimated fair value of
the derivative feature is recorded separately from the carrying value of the host contract, with subsequent changes in the estimated
fair value recorded as a non-operating gain or loss in the Company’s consolidated statements of operations.
Income Taxes
The Company accounts for income taxes under
the asset and liability method. Under this method, deferred income tax assets and liabilities are determined based on differences
between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are
expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred income tax assets
is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or
all of a deferred income tax asset will not be realized based on the weight of available evidence, including expected future earnings.
The Company recognizes an uncertain tax
position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination
based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required.
Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized
upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or
measurement is reflected in the period in which such change occurs. Interest and penalties related to income taxes are recognized
in the provision for income taxes.
Loss Per Common Share
Basic net loss per common share is computed
by dividing the net loss applicable to common stockholders by the weighted average number of common shares outstanding for each
period presented. Net loss applicable to common stockholders is further adjusted to deduct BCFs that arise from deemed dividends
as discussed above. Diluted net loss per common share is computed by giving effect to all potential shares of Common Stock, including
stock options and warrants, to the extent dilutive.
Recent Accounting Pronouncements
Recently
Adopted Standards. The following accounting standards were adopted during the fiscal year ended June 30, 2020:
In February 2016, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842).
This ASU requires the Company to recognize right-of-use assets and operating lease liabilities on the balance sheet, and also disclose
key information about leasing arrangements. On July 1, 2019, the Company adopted this new standard using the modified retrospective
approach in accordance with ASU No. 2018-11, Leases - Targeted Improvements . The Company elected the package of practical
expedients permitted under the transition guidance within ASU No. 2018-11, which among other things, allowed the Company to
carry forward the historical lease classification of those leases in place as of July 1, 2019. The impact of adoption resulted
in the recognition of right-of-use assets and operating lease liabilities for the discounted present value of the future lease
payments on leases that were in effect on July 1, 2019, as follows (in thousands):
37
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Right-of-use assets recorded under new standard
$ 605
Operating lease liabilities recorded under new standard:
Current
$ 227
Long-term
406
Total
633
Eliminate previously existing deferred rent liability
(28 )
Net increase in liabilities due to adoption of new standard
$ 605
Please refer to Note 3 for further information
about the right-of-use assets and operating lease liabilities recognized under this standard. Due to the Company’s election
to adopt this standard effective July 1, 2019, rent expense was recognized under the accounting standard that was previously
in effect for all periods prior to July 1, 2019.
In June 2018, the FASB issued
ASU 2018-07, Compensation — Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment
Accounting , which expands the scope of ASC 718 to include share-based payment transactions for acquiring goods and
services from non-employees. The new standard does not apply to warrants issued to a lender or investor in a financing
transaction. The Company adopted ASU 2018-07 effective July 1, 2019. Prior to the adoption of ASU 2018-07, the Company
accounted for stock options and warrants granted to non-employees based on the fair value of the goods and services, or the
equity instrument, whichever could be measured more reliably. If fair value of the equity instrument was more reliably
determined, fair value of the equity instrument was required to be re-measured until the performance commitment date was
achieved, which resulted in the recognition of subsequent changes in fair value. Under the new standard, the fair value of
the goods and services acquired from non-employees is solely determined using the fair value of the equity instruments issued
and measurement of fair value is fixed on the grant date. The Company also made an accounting policy election to recognize
the impact of forfeitures of non-employee awards in the period that the forfeiture occurs. The impact of adopting this
standard was immaterial to the Company’s consolidated financial statements.
Standard
Required to be Adopted in Future Years. The following accounting standard is not yet effective; management has
not completed its evaluation to determine the impact that adoption of this standard will have on the Company’s consolidated
financial statements.
In June 2016, the FASB issued
ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. ASU 2016-13 amends the guidance on the impairment of financial instruments. This update adds an impairment
model (known as the current expected credit losses model) that is based on expected losses rather than incurred losses. Under
the new guidance, an entity recognizes, as an allowance, its estimate of expected credit losses. In November 2019,
ASU 2016-13 was amended by ASU 2019-10, Financial Instruments- Credit Losses (Topic 326), Derivatives and Hedging
(Topic 815), and Leases (Topic 842) whereby the effective date for ASU 2016-13 for smaller reporting companies is now
required for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The
Company does not expect the adoption of this accounting guidance will have a material impact on its consolidated financial
statements.
Other accounting standards that have been
issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not currently
expected to have a material impact on the Company’s financial statements upon adoption.
Note
2 — Liquidity
The Company is in the clinical stage and
has not yet generated any revenues. For the fiscal year ended June 30, 2020, the Company incurred a net loss of $20.3 million
and net cash used in operating activities amounted to $24.2 million. As of June 30, 2020, the Company had an accumulated deficit
of $147.2 million, cash and cash equivalents of $10.0 million and total liabilities of $3.6 million.
38
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
As discussed in Note 14, on
October 9, 2020 the Company received aggregate gross proceeds from investors in a private placement of approximately
$41.0 million from the issuance of units that consisted of approximately 2.5 million shares of Common Stock and warrants for
the purchase of approximately 0.8 million shares of Common Stock. Management believes the Company’s existing cash and
cash equivalents balance plus the net proceeds from the private placement of $37.6 million will be adequate to carry out
currently planned activities into the second half of fiscal year ending June 30, 2022.
As discussed in Note 9, COVID-19 has resulted
in an economic environment that is unfavorable for many businesses to conduct operations and pursue new debt and equity financings.
The U.S. economy has been largely shut down by mass quarantines and government mandated stay-in-place orders to halt the spread
of the virus. While these orders are being lifted gradually, there is considerable uncertainty surrounding the recovery period
for the U.S. economy. The long-term effects on the Company are expected to result in higher costs in order to comply with safeguards
to protect patients and staff engaged in clinical activities, and extended periods of time may be required to complete clinical
trials. The current economic environment and financial market volatility is expected to make it more challenging for the Company
to obtain funding for its clinical programs in the future. Even if an economic recovery occurs faster and more robustly than currently
expected, there are no assurances that the Company will be able to obtain equity and debt financings that will be necessary to
fund ongoing operations after the fiscal year ending June 30, 2022. In addition, even if these financing sources are available,
they may be on terms that are not acceptable to the Company’s Board of Directors and stockholders.
Note 3 — LEASES
As
discussed in Note 1, the Company adopted ASU 2016-02, Leases (Topic 842) effective July 1, 2019. As of
July 1, 2019, the Company had two leases in effect, consisting of (i) a lease for its headquarters location in
Redwood City, California that was entered into on January 25, 2019, that provides for monthly rent of approximately
$21,000 through the expiration date in March 2022, and (ii) a lease for office space in Bend, Oregon entered into
on February 7, 2019, that provides for monthly rent of approximately $2,700 through the expiration date in
February 2021. The impact of adoption of ASU 2016-02 resulted in the recognition of ROU assets for $0.6 million and
operating lease liabilities for the discounted present value of the future lease payments on these leases of approximately
$0.6 million. For the year ended June 30, 2020, under ASC 842 the Company had operating lease expense of $0.3 million,
of which $0.2 million was included in research and development costs and $0.1 million was included in general and
administrative expenses. For the year ended June 30, 2019 under the previous accounting standard, the Company had
operating lease expense of $0.4 million, of which $0.3 million was included in research and development costs and $0.1
million was included in general and administrative expenses.
The Company determined the operating lease
liability of approximately $633,000 as of July 1, 2019 based upon a discount rate of 10.0% and assuming that the Company will
not exercise its option to extend the headquarters lease for an additional three years. The discount rate represents the Company’s
estimated incremental borrowing rate for debt with similar lender rights as the underlying operating lease terms.
Balance Sheet Presentation
As of June 30, 2020 and on the
adoption date of July 1, 2019, the carrying value of ROU assets and operating lease liabilities were as follows (in
thousands):
June 30,
July 1,
2020
2019
Right-of-Use Assets, net
$ 383
$ 605
Operating Lease Liabilities:
Current
$ 245
$ 227
Long-term
165
406
Total
$ 410
$ 633
39
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
As of June 30, 2020, the weighted
average remaining lease term under operating leases was 1.6 years, and the weighted average discount rate for operating lease
liabilities was 10.0%. For the year ended June 30, 2020, cash paid for amounts included in the measurement of operating lease
liabilities amounted to $0.3 million, which is included in the determination of net cash used in operating activities in the consolidated
statement of cash flows.
Future Lease Payments
Future payments under operating lease
agreements as of June 30, 2020 are as follows (in thousands):
Fiscal year ending June 30,
2021
$ 272
2022
170
Total lease payments
442
Less imputed
interest
(32 )
Present value
of operating lease liabilities
$ 410
Restructuring Activity
In April 2018, the Company implemented
a restructuring plan to discontinue manufacturing activities and attempt to sublease facilities in Louisville, Colorado. In December 2018,
the Company vacated its leased office and laboratory space in Colorado, resulting in an impairment charge of approximately $33,000
and a loss on sale of approximately $12,000 related to leasehold improvements, laboratory equipment, furniture, equipment and
fixtures. The impairment charge and the loss on sale are included in facilities and other general and administrative expenses
in the accompanying statement of operations for the fiscal year ended June 30, 2019.
In December 2018, the Company entered
into surrender agreements with its landlord, sub-landlord and sub-lessees to terminate all lease and sub-lease obligations at
the Company’s former Colorado facilities. Accordingly, the Company was relieved of its remaining obligations under the leases
and relinquished its rights under the lease and sublease agreements whereby no cash was exchanged by the parties and the Company
recognized a net gain on lease termination of approximately $0.2 million. This gain is included in interest and other income in
the accompanying statement of operations for the fiscal year ended June 30, 2019.
Note
4 — License Agreements
Xoma License Agreement
On December 6,
2017, the Company entered into a license agreement (“License Agreement”) with XOMA Corporation (“Xoma”),
through its wholly-owned subsidiary, XOMA (US) LLC, pursuant to which Xoma granted an exclusive global license to the Company
to develop and commercialize Xoma 358 (formerly X358, now RZ358) for all indications. Additionally, upon the future commercialization
of RZ358, the Company will be required to pay royalties to Xoma based on the net sales of the related products. On January 7,
2019, the License Agreement was amended whereby the Company was required to make five cash payments to Xoma totaling $8.5 million
on or before specified staggered future dates (the “Future Cash Payments”). As a result of this amendment to
the License Agreement, the Company recognized a liability in January 2019 for the entire $8.5 million of Future Cash Payments.
40
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
The January 2019
amendment to the License Agreement provided that if future qualified financings occurred before the Future Cash Payments were
fully paid, the Company was required to pay Xoma 15% of the net proceeds from such financings (“Early Payments”) to
be credited against the remaining unpaid Future Cash Payments in the reverse order of their future payment date. Obligations
to make the Future Cash Payments following a qualified financing and the obligations to make Early Payments shall end when the
Future Cash Payments are fully paid for the total of $8.5 million. As discussed in Note 5, the Company completed equity
financings for net proceeds of approximately $22.6 million in July and August 2019, which met the definition of a qualified
financing and resulted in the obligation to make Early Payments of approximately $3.4 million.
On March 31,
2020, the parties entered into Amendment No. 3 to the License Agreement to extend the payment schedule for the remaining
balance of approximately $2.6 million. The revised payment schedule provides for seven quarterly payments to be paid from March 31,
2020 through September 30, 2021. Pursuant to Amendment No. 3, the Company is obligated to repay the remaining outstanding
balance within 15 days following a financing for $20.0 million or more. Presented below is a summary of cash payments under the
amended License Agreement, and the impact of Amendment No. 3 on the remaining payment obligations as of June 30, 2020
(in thousands):
Balance
Balance
June 30,
Cash
Payments
Amendment
June 30,
Scheduled Payment Date
2019
Early
Scheduled
No. 3
2020
September 30, 2019
$ 1,500
$ -
$ (1,500 )
$ -
$ -
December 31, 2019
1,000
-
(1,000 )
-
-
March 31, 2020
2,000
-
(400 )
(1,600 )
-
June 30, 2020
2,000
(1,391 )
(400 )
(209 )
-
September 30, 2020
2,000
(2,000 )
-
400
400
December 31, 2020
-
-
-
400
400
March 31, 2021
-
-
-
400
400
June 30, 2021
-
-
-
400
400
September 30, 2021
-
-
-
209
209
Total
8,500
$ (3,391 )
$ (3,300 )
$ -
1,809
Less long-term portion of payable
(2,000 )
(209 )
Current portion of payable
$ 6,500
$ 1,600
As discussed in Note 14, the Company completed
a private placement of equity securities for gross proceeds of $41.0 million in October 2020, which resulted in acceleration
of the entire obligation shown above which is now payable by October 2020. The January 2019 amendment to the License
Agreement also revised the amount the Company is required to expend on development of RZ358 and related licensed products, and
revised provisions with respect to the Company’s diligence efforts in conducting clinical studies.
In addition to the License Agreement entered
between the Company and Xoma in December 2017, both parties also entered into a stock purchase agreement (“Stock Purchase
Agreement”) whereby Xoma owns approximately 162,000 shares of the Company’s Common Stock as of June 30, 2020.
Until such time that the Company’s shares of Common Stock are traded on a national stock exchange, the Stock Purchase Agreement
provides Xoma with the right and option to require the Company to use its best efforts to facilitate orderly sales of the shares
to a third party or purchase the shares (the “Put Option”). Xoma may exercise the Put Option for up to a total of
50,000 shares of Common Stock for the calendar year ending December 31, 2020, and up to an additional 50,000 shares
thereafter. If Xoma subsequently exercises the Put Option, the Company is required to use its best efforts to assist Xoma in facilitating
the sale of shares to third-party purchasers or purchase the shares for its own account. The price per share under the Put Option
is equal to the average of the closing bid and asked prices of the Common Stock on the date the Put Option is exercised.
ActiveSite License Agreement
On August 4, 2017, the Company entered
into a Development and License Agreement with ActiveSite Pharmaceuticals, Inc. (“ActiveSite”) pursuant
to which the Company acquired the rights to ActiveSite’s Plasma Kallikrein Inhibitor program (“PKI Portfolio”).
The Company is initially using the PKI Portfolio to develop an oral PKI therapeutic for diabetic macular edema (RZ402) and may
use the PKI Portfolio to develop other therapeutics for different indications. The ActiveSite License Agreement requires
various milestone payments ranging from $1.0 million to $10.0 million when milestone events occur, up to $46.5 million of aggregate
milestone payments. The first milestone payment for $1.0 million relates to the Company’s RZ402 drug candidate and is due
after completion of the preclinical work and submission of an Initial Drug Application, or IND, to the U.S. Food and Drug Administration.
The Company is also required to pay royalties equal to 2.0% of any sales of products that use the PKI Portfolio. Through June 30,
2020, no events have occurred that would result in the requirement to make milestone payments and no royalties have been incurred.
41
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Note
5 — Convertible Notes Payable
Between January and April 2018,
the Company entered into convertible notes payable with an aggregate principal balance of $5.3 million (the “Fiscal 2018
Notes”). The Fiscal 2018 Notes provided for interest at the contractual rate of 15.0% for the period from July 1, 2019
through the conversion date. The Fiscal 2018 Notes also provided that the unpaid principal and accrued interest would automatically
convert at a 20% discount to the class of securities issued upon completion of a subsequent equity financing for at least $15
million. This feature that enabled conversion at a discount was a contingent BCF that was not calculated and recorded until the
financing that triggered conversion was completed. The closing of the Series AA Financing resulted in the conversion of the
Fiscal 2018 Notes whereby the contingent BCF was measured and recognized on January 30, 2019 as shown below (in thousands).
Debt as of January 30, 2019
Debt Converted to Series
Series AA Preferred Stock
Beneficial
Original
Accrued
AA Preferred Stock
Converted to Common Stock
Conversion
Date of Borrowing
Principal
Interest
Total
Shares
Fair Value
Shares
Fair Value
Feature
January 2018
$ 500
$ 95
$ 595
74
$ 744 (1)
68
$ 811 (2)
$ 216 (3)
February 2018
700
102
802
100
1,002 (1)
91
1,094 (2)
292 (3)
April 2018
4,140
603
4,743
594
5,929 (1)
539
6,468 (2)
1,725 (3)
Total
$ 5,340
$ 800
$ 6,140
768
$ 7,675 (1)
698
$ 8,373 (2)
$ 2,233 (3)
(1) Fair
value was based on the $10.00 per share issuance price for Series AA Preferred Stock
as discussed in Note 6.
(2) The
shares of Series AA Preferred Stock were immediately convertible to shares of Common
Stock at a price of $11.00 per share. Fair value was based on the closing price of the
Company’s Common Stock of $12.00 per share on January 30, 2019.
(3) The
beneficial conversion feature represents the difference between the fair value of the
share of Common Stock and the total debt balance as of January 30, 2019.
Presented below is a summary of the components of interest
expense related to Fiscal 2018 Notes for the fiscal year ended June 30, 2019 (in thousands):
Interest expense at contractual rate
$ 672
Accretion of discount
2,053
Beneficial conversion feature
for Fiscal 2018 Notes
2,233
Total interest
expense
$ 4,958
Note
6 — Stockholders’ Equity
Changes in Authorized Capital Stock
On April 24, 2019, the Company’s
stockholders approved an amendment to the Certificate of Incorporation to (i) increase the authorized number of shares of
Common Stock from 200 million shares to 500 million shares, and (ii) rescinded the previous designation of 15.0 million shares
of Series A Preferred Stock. As a result of this action, the Company had authority to designate and issue up to 20.0 million
shares of Preferred Stock as of June 30, 2020 and 2019.
Series AA Preferred Stock Financing
In December 2018, two investors expressed
interest in investing in the Company and affirmed their intent to enter into exclusive diligence and negotiations regarding a
potential equity financing (“Transaction”). In exchange for the receipt of a total of $1.5 million ("Exclusivity
Payment"), the Company entered into an exclusivity agreement with Handok, Inc. (“Handok”) and Genexine, Inc.
(“Genexine”). On January 7, 2019, the parties entered into a Purchase Agreement for Shares of Series AA
Preferred Stock (the “Purchase Agreement”) whereby Handok and Genexine (collectively referred to as “H&G”)
agreed to purchase shares of newly designated Series AA Preferred Stock (the “Series AA Financing”) for
aggregate gross proceeds to the Company of $25.0 million (inclusive of the $1.5 million Exclusivity Payment). On January 18,
2019, the board of directors authorized the designation of 5.0 million shares of the Company’s Preferred Stock as Series AA
Preferred Stock. On January 30, 2019, the parties closed the Series AA Financing and the Company issued an aggregate
of 2.5 million Series AA shares to H&G at a purchase price of $10.00 per share.
42
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
The
Series AA Shares held by H&G were convertible into shares of Common Stock at a conversion price of approximately $11.00
per share. The fair value of the Company’s Common Stock on the issuance date of the Series AA Preferred Stock was $12.00
per share which resulted in a BCF of approximately $2.3 million. Since the Series AA Shares were classified as equity instruments,
this BCF has been treated as an adjustment in computing net loss attributable to common stockholders shown in Note 12.
A
condition to closing the Series AA Financing was the resignation of a majority of the Company’s former directors and
the appointment of representatives of H&G as directors whereby H&G collectively controlled the board of directors. On
April 24, 2019, the Company’s stockholders approved an increase in the number of authorized shares of Common Stock
whereby all 2.5 million shares of Series AA Preferred Stock held by H&G automatically converted into approximately
2.3 million shares of the Company’s Common Stock.
Due to closing of the Series AA Financing
for gross proceeds of $25.0 million, the Company’s outstanding Fiscal 2018 Notes in the aggregate principal and accrued
interest balance of $6.1 million automatically converted into approximately 0.8 million shares of Series AA Preferred Stock,
resulting in an effective issuance price of $8.00 per share after giving effect to the 20% discount included in the terms of the
Fiscal 2018 Notes. This 20% discount resulted in the recognition of a BCF for $2.2 million that was charged to interest expense
for the year ended June 30, 2019.
Upon
receipt of stockholder approval for an increase in the number of authorized shares of Common Stock to 500 million shares on
April 24, 2019, all 3.3 million shares of Series AA Preferred Stock held by Handok, Genexine and the former holders
of the Fiscal 2018 Notes converted into an aggregate of approximately 3.0 million shares of the Company’s
Common Stock as set forth below (in thousands, except per share amounts):
Series AA Preferred Stock
Common Stock Conversion
Number
Conversion Value
Price Per
Number of
Holders
of Shares
Per Share
Amount
Share
Shares
H&G
2,500
$ 10.00
$ 25,000
$ 11.00
2,273
Fiscal 2018 Note holders
768
10.00
7,675
11.00
698
Total
3,268
$ 32,675
2,971
Fiscal 2020 Private Placement
In connection with the Series AA
Financing discussed above, the Company granted call options to H&G whereby upon the earlier of (i) December 31,
2020 and (ii) such date that the Company requests H&G to provide additional financing, H&G were entitled to purchase
up to an aggregate of $20.0 million of Common Stock at a purchase price equal to the greater of (i) $14.50 per share or (ii) 75%
of the volume weighted average closing price (“VWAP”) of the Company’s Common Stock during the thirty consecutive
trading days prior to the date of the notice.
On
June 19, 2019, the Company entered into a financial advisory agreement to undertake a private placement (the “Private
Placement”) of (i) the shares of Common Stock issuable under the call options for a total of $20.0 million, plus (ii) up
to $10 million of equity or equity equivalent securities to be issued to other investors. On July 23, 2019, the Company entered
into a purchase agreement whereby H&G exercised their call options to purchase an aggregate of approximately 1.4 million shares
of Common Stock for gross cash proceeds of $20.0 million at a purchase price of $14.50 per share. As of June 30, 2020, H&G
collectively owned approximately 62% of the Company’s Common Stock which resulted in a change of control.
During July and August 2019,
other investors purchased an aggregate of approximately 279,000 shares of Common Stock at a purchase price of $14.50 per share
for gross cash proceeds of $4.1 million. Pursuant to the financial advisory agreement, the Company paid a fee of 6.0% of the gross
proceeds received from these private placements. The total advisory fees and other offering costs related to these issuances in
July and August 2019 amounted to approximately $1.5 million, resulting in net proceeds of $22.6 million for the fiscal
year ended June 30, 2020. As discussed in Note 4, the completion of these financings resulted in the obligation to make Early
Payments of approximately $3.4 million under the License Agreement with Xoma. With the closing of the Private Placement, under
the terms of the financial advisory agreement until August 2020, the financial advisors have a right of first refusal to
serve as Joint Bookrunners or Joint Placement Agents in any offering the Company undertakes.
43
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Restricted Cash
In connection with the private placement
discussed above, one of the investors purchased approximately 262,000 shares of Common Stock for gross proceeds of $3.8 million.
The Company agreed to spend the proceeds for research and development of RZ358 or for the Company’s planned uplisting of
its Common Stock to a national stock exchange. For the year ended June 30, 2020, the Company expended the entire amount of
the restricted cash proceeds on qualified activities whereby there are no restrictions on cash balances as of June 30, 2020.
Lincoln Park Purchase Agreement
In
December 2017, the Company entered into a purchase agreement (the “Purchase Agreement”) and a registration
rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant to which Lincoln Park agreed to purchase
up to an aggregate of $10.0 million of the Company’s Common Stock (subject to certain limitations) over the term of the
agreement that expires in December 2020. Subject to restrictions in the Purchase Agreement and so long as the closing price
of the Company’s Common Stock exceeds $20.00 per share, the Company may elect to require Lincoln Park to purchase up to
$10.0 million of shares of the Company’s Common Stock. The Company’s Common Stock has not exceeded the threshold price
of $20.00 per shares for the period from August 2018 through June 2020. The Company has the right to terminate the Purchase
Agreement at any time, at no cost or penalty.
Note
7 — Stock-Based Compensation and Warrants
Stock Option Plans
The Company currently has two active stock
option plans consisting of the 2016 Non-Qualified Stock Option Plan, as amended (the “2016 Plan”), and the 2019 Non
Qualified Stock Option Plan (the “2019 Plan”). On July 31, 2019, the 2019 Plan was adopted by the Board of Directors
and provides authority to grant non-qualified stock options for up to 300,000 shares of the Company’s Common
Stock. The Company also has stock options outstanding to purchase up to approximately 44,000 shares of Common Stock under the
2014 Stock and Incentive Plan (the “2014 Plan”) that terminated on March 21, 2019 and approximately 95,000 shares
of Common Stock under the 2015 Stock and Incentive Plan (the “2015 Plan”) that terminated on February 23, 2020.
Stock options outstanding under the 2014 Plan and the 2015 Plan expire pursuant to their contractual provisions on various dates
through 2029. Presented below is a summary of the number of shares authorized, outstanding, and available for future grants under
each of the Company’s stock option plans (in thousands):
Termination
Number of Shares
Description
Date
Authorized
Outstanding
Available
2014 Plan
March 2019
44
44
-
2015 Plan
February 2020
95
95
-
2016 Plan
October 2021
560
524
36
2019 Plan
July 2029
300
300
-
Total
999
963
36
44
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
July 2019
Grants
On
July 31, 2019, the Board of Directors granted stock options for an aggregate of approximately 679,000 shares of Common Stock
to certain officers and employees at an exercise price of $14.50 per share (the “July 2019 Grants”). The closing
price of the Company’s Common Stock on the date of grant was approximately $10.50 per share. The July 2019 Grants were
designated for approximately 379,000 shares under the 2016 Plan and 300,000 shares under the 2019 Plan. As of July 31, 2019,
the number of shares subject to stock options, the related fair value and compensation that was immediately recognized for options
that immediately vested are as follows (in thousands):
Time-Based Vesting
Unvested
Number of Shares
Hybrid
Vested
Unvested
Options
Total
Executive officers
72 (1)
231 (1)
151 (2)
454
Other employees
18 (1)
133 (1)
74 (2)
225
Total
90
364
225 (5)
679
Total fair value
$ 817 (3)
$ 3,297 (4)
(1) Stock
options that are subject to time-based vesting become exercisable (i) for employees
who were employed by the Company for more than one year as of the grant date, 25% of
such options were immediately exercisable, and for employees that were employed by the
Company for less than one year as of the grant date, 25% of such options will vest on
the one year anniversary of the employee’s hire date, and (ii) the remaining
75% of the stock options will vest ratably over a period of 36 months beginning on the
vesting date for the initial 25% tranche.
(2) Stock
options that commence vesting upon the achievement of market, performance and service
conditions (‘Hybrid Options”) will vest ratably over a period of 36 months
beginning on the date that all of the following have occurred: (i) the option recipient
has been employed by the Company for at least one year, (ii) the Company’s
shares of Common Stock have been listed for trading on a national stock exchange, and
(iii) such date no later than July 31, 2023, when the Company’s closing
stock price exceeds $29.00 per share for 20 trading days in any consecutive 30 day period.
(3) Represents
the aggregate grant date fair value for stock options that were immediately vested on
the grant date, which is included in stock-based compensation expense for the year ended
June 30, 2020.
(4) Represents
the aggregate grant date fair value for stock options that were not immediately vested
on the grant date and are being charged to expense from the grant date through the respective
vesting dates through July 2023.
(5) The
Company has not recognized any expense related to these stock options for the year ended
June 30, 2020, since it is not yet probable that the performance condition will
be achieved. The Company will begin recognizing compensation expense at such time that
the performance condition is probable and continuing through the end of the requisite
service period. Determination of the requisite service period for the Hybrid Options
will be calculated on the date that the performance condition is considered probable
using grant date fair value.
45
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Stock
Options Outstanding
The
following table sets forth a summary of the combined stock option activity under all of the Company’s stock option plans
for the years ended June 30, 2020 and 2019 (shares in thousands):
2020
2019
Shares
Price
(1)
Term
(2)
Shares
Price
(1)
Term
(2)
Outstanding, beginning
of fiscal year
277
$ 79.88
6.4
388
$ 77.50
7.8
Stock options
granted:
Awards with
time-based vesting
497
14.50
23
26.00
Awards with
performance-based vesting
225
14.50
-
-
Stock options
forfeited:
Awards with
time-based vesting
(25 )
24.39
(134 )
76.50
Awards
with performance-based vesting
(11 )
14.50
-
-
Outstanding,
end of fiscal year
963
33.06
8.1
277
79.88
6.4
Vested,
end of fiscal year
431
53.14
6.9
192
92.50
5.7
(1) Represents
the weighted average exercise price.
(2) Represents
the weighted average remaining contractual term until the stock options expire.
For
the year ended June 30, 2020, the aggregate fair value of stock options granted for
approximately 497,000 shares of Common Stock that provide solely for time-based vesting, amounted to $4.2 million or approximately
$8.38 per share as of the grant date. For the year ended June 30, 2020, the aggregate fair value of stock options granted
for 225,000 shares of Common Stock that provide for hybrid vesting, amounted to $2.1 million or approximately $9.51
per share as of the grant date. For the year ended June 30, 2019, the aggregate fair value of stock options granted for 22,500 shares of Common Stock that provide solely for time-based vesting amounted to $0.4 million or approximately $19.79 per
share as of the grant date. Fair value was computed using the BSM option-pricing model and will result in the recognition of compensation
cost ratably over the expected vesting period of the stock options. For the years ended June 30, 2020 and 2019, the fair
value of stock options that provide for time-based and hybrid vesting was estimated on the date of grant using the BSM option-pricing
model, with the following weighted-average assumptions:
2020
2019
Time-Based
Hybrid
Time-Based
Market price of common stock on grant date
$ 10.23
$ 10.61
$ 26.00
Expected volatility
118 %
118 %
84 %
Risk free interest rate
1.9 %
2.0 %
2.8 %
Expected term (years)
5.7
8.0
7.0
Dividend yield
0 %
0 %
0 %
Stock-based
compensation expense for the fiscal years ended June 30, 2020 and 2019 is included in compensation and benefits under the
following captions in the consolidated statements of operations (in thousands):
2020
2019
Research and development
$ 1,589
$ 538
General and administrative
1,728
2,098
Total
$ 3,317
$ 2,636
Unrecognized
stock-based compensation expense for stock options that provide solely for time-based vesting as of June 30, 2020 was approximately
$3.4 million. This amount is expected to be recognized over a remaining weighted average period of 1.9 years. Unrecognized
compensation cost for the Hybrid Options will be recognized beginning on the date that the performance condition becomes probable
using the grant date fair value. Based on preliminary estimates using the BSM option-pricing model, management believes the aggregate
fair value of the Hybrid Options will be approximately $2.1 million before adjusting for forfeitures. As of June 30, 2020
and 2019, there was no intrinsic value associated with any outstanding stock options.
46
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Warrants
The
Company has issued warrants to purchase shares of Common Stock in conjunction with various debt and equity financings and for
services. As of June 30, 2020 and 2019, all of the warrants are vested. For the fiscal years ended June 30, 2020 and
2019, no warrants were exercised. Presented below is a summary of grants, modifications and expirations for
the fiscal years ended June 30, 2020 and 2019 (shares in thousands):
2020
2019
Shares
Price
(1)
Term
(2)
Shares
Price
(1)
Term
(2)
Outstanding, beginning
of fiscal year
920
$ 66.80
3.4
913
$ 68.29
3.4
Warrants issued
for consulting services
14 (3)
14.50
-
-
Modification
for debt discount to former
member of Board of Directors:
Replacement
warrant
-
-
24 (4)
9.00
Canceled warrant
-
-
(10 ) (4)
25.94
Warrant
expirations
(316 )
82.78
(7 )
120.27
Outstanding,
end of fiscal year
618
57.46
2.3
920
66.80
3.4
(1) Represents
the weighted average exercise price.
(2) Represents
the weighted average remaining contractual term for the number of years until the warrants
expire.
(3) Represents
warrants granted for consulting services in November 2019 with an expiration date
in November 2024. The fair value of the warrants of $67,000 was determined using
the BSM model. Since the warrants were immediately vested, this entire amount is included
in consulting and outside services under research and development expenses for the year
ended June 30, 2020. Key assumptions for the valuation of these warrants included
the closing price of the Company’s shares of Common Stock of $14.50 on the grant
date, the exercise price of $6.50 per share, historical volatility of 119%, and an expected
term of 5.0 years.
(4) In
January 2019, the Company agreed to modify a warrant originally issued in June 2018 for 10,000 shares that was exercisable at
$25.94 per share. This warrant was originally issued in connection with one of the Fiscal 2018 Notes issued to a former member
of the Board of Directors. The difference between the fair value of the modified warrant and the fair value of the canceled warrant
amounted to $138,000, which was accounted for as an additional debt discount that was charged to interest expense upon repayment
of the Fiscal 2018 Notes on January 30, 2019. Key assumptions for valuation of the modified warrant and the canceled warrant included
the fair value of Company's Common Stock on the modification date of $11.50 per share, expected volatility of 100%, a risk-free
interest rate of 2.5%, and an estimated remaining term of 4.0 years.
Note
8 — Income Taxes
Income
Tax Expense
For
the fiscal years ended June 30, 2020 and 2019, the reconciliation
between the income tax benefit computed by applying the statutory U.S. federal income tax rate to the pre-tax loss before income
taxes, and total income tax expense recognized in the financial statements is as follows (in thousands):
2020
2019
Income tax benefit at statutory U.S. federal rate
$ 4,270
$ 6,394
Income tax benefit attributable to U.S. states
1,420
1,876
Non-deductible expenses
(12 )
(1,045 )
Stock option expirations
(52 )
(1,484 )
Other
392
(328 )
Change in valuation allowance
(6,018 )
(5,413 )
Total income tax expense
$ -
$ -
For
the fiscal years ended June 30, 2020 and 2019, the Company did
not recognize any current income tax expense or benefit due to a full valuation allowance on its deferred income tax assets.
47
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Deferred
Income Tax Assets and Liabilities
As
of June 30, 2020 and 2019, the income tax effects of temporary
differences that give rise to significant deferred income tax assets and liabilities are as follows (in thousands):
2020
2019
Deferred income tax assets:
Net operating loss
carryforwards
$ 21,651
(1)
$ 20,016
Intangible assets
5,182
(1)
-
Stock-based compensation
4,592
3,716
Start-up and organizational
expenses
203
338
Accrued expenses and other
47
1,598
Total deferred income tax assets
31,675
25,668
Valuation allowance for deferred
income tax assets
(31,674 )
(25,656 )
Net deferred income tax assets
1
12
Deferred income tax liability- property, equipment
and other
(1 )
(12 )
Net deferred income tax assets
$ -
$ -
(1) Amounts
include the impact of giving effect to the reclassification of approximately $4.1 million
from net operating loss carryforwards to intangible assets due to license fees that were
incorrectly expensed for income tax purposes in previous fiscal years. During the fiscal
year ended June 30, 2020, the Company’s income tax returns were corrected
whereby these license costs were capitalized and are being amortized over 15 years for
income tax purposes. Due to the valuation allowance for deferred income tax assets in
previous years, this reclassification did not have any impact on the Company’s
previously reported net losses or accumulated deficit.
For
the fiscal year ended June 30, 2020, the valuation allowance increased
by $6.0 million, primarily as a result of the increase in net operating losses. In assessing the realizability of deferred income
tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets
will not be realized.
NOL
Carryforwards and Other Matters
The
Company files income tax returns in the U.S. federal jurisdiction and the states of Colorado and California. The Company’s
federal and state tax years for the 2017 fiscal year and forward are subject to examination by taxing authorities. As of June 30,
2020, the Company has U.S. federal NOL carryforwards of approximately $85.2 million, of which approximately $30.6 million does
not expire and $54.6 million will begin to expire in 2031. Additionally, the Company has Colorado and California NOL carryforwards
that begin to expire in 2031.
Federal
and state laws impose substantial restrictions on the utilization of NOL carryforwards in the event of an ownership change
for income tax purposes, as defined in Section 382 of the Internal Revenue Code (“IRC”). Pursuant to IRC
Section 382, annual use of the Company’s NOL carryforwards may be limited in the event a cumulative
change in ownership of more than 50% occurs within a three-year period. The Company has not completed an IRC Section 382
analysis regarding the limitation of NOL carryforwards. However, it is possible that past ownership changes
will result in the inability to utilize a significant portion of the Company’s NOL carryforward that was
generated prior to any change of control. The Company’s ability to use its remaining NOL carryforwards
may be further limited if the Company experiences an IRC 382 ownership change in connection with future changes in
the Company’s stock ownership.
The
Company did not have any unrecognized tax benefits as of June 30,
2020 and 2019. The Company’s policy is to account for any interest expense and penalties for unrecognized tax benefits as
part of the income tax provision. The Company does not anticipate that unrecognized tax benefits will significantly increase or
decrease within the next twelve months.
48
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Note
9 — Commitments
and Contingencies
Milestone
Payments and Royalties
Please
refer to Note 4 for further discussion of commitments to make milestone payments and to pay royalties under license agreements.
COVID-19
In
December 2019, COVID-19 was reported to have surfaced in Wuhan, China, and by March 2020 the spread of the virus had
resulted in a world-wide pandemic. The U.S. economy has been largely
shut down by mass quarantines and government mandated stay-in-place orders to halt the spread of the virus. While these orders
are being lifted gradually, a full recovery of the U.S. economy may not occur until 2021 or later. Federal and state governments
in the U.S. have approved funding for many programs that may provide financial assistance to individuals and businesses. The Company
intends to pursue all material types of government assistance that it may be entitled to. However, no assurance can be provided
that the Company will qualify and realize any material benefits from such assistance.
COVID-19
has resulted in an economic environment that is unfavorable for many businesses to pursue new equity financings. Accordingly,
the current economic environment is expected to present greater challenges for the Company to obtain additional funding for its
clinical programs on terms that are acceptable to the Company’s Board of Directors.
In
February 2020, Rezolute announced the initiation of its Phase 2b trial in Congenital
Hyperinsulinism (“CHI”). New site initiation and enrollment is on hold, similar to many other clinical studies conducted
by other companies throughout the world. There are no mitigation strategies we can employ to help avoid potential timeline delays
should there be an extended enrollment pause due to COVID-19. The long-term effects of COVID-19 are expected to require additional
safeguards to protect patients and staff engaged in clinical activities, and extended periods of time required to complete clinical
trials, both of which are expected to result in higher overall costs. While the current business disruption is expected to be
temporary, the long-term financial impact and the duration cannot be reasonably estimated at this time.
Employment
Agreements
As
of June 30, 2020, the Company was subject to employment agreements with three executive officers that provide for aggregate
annual base salaries of $1.2 million. In the event the Company terminates employment of the executive officers without cause,
severance benefits include (i) between one and three years of base salary, (ii) between 50% and 150% of annual target
bonuses applicable to the terminated executive, and (iii) continuation of certain medical and dental benefits. In addition,
vesting is accelerated for unvested stock options that would have otherwise vested during the period that the severance benefits
are paid out.
401(k) Plan
The
Company has a defined contribution employee benefit plan under section 401(k) of the Internal Revenue Code (the “401(k) Plan”).
The 401(k) Plan covers all eligible employees who are entitled to participate six months after commencement of employment.
The Company matches contributions up to 4% of the participating employee’s compensation with such matching contributions
vested immediately. Total contributions by the Company to the 401(k) Plan amounted to approximately $0.1 million for each
of the fiscal years ended June 30, 2020 and 2019.
Legal
Matters
From
time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business.
As of June 30, 2020, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect
on the Company’s results of operations. At each reporting period,
the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable
under ASC 450, Contingencies . Legal fees are expensed as incurred.
49
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Note
10 — Related Party Transactions
Equity Issuances
As discussed in Note 6, on July 23,
2019 H&G agreed to purchase an aggregate of approximately 1.4 million shares of Common Stock at an issuance price of $14.50
per share for gross proceeds of $20.0 million. This purchase was made pursuant to the terms of the call option that was issued
in connection with an equity offering in January 2019 that resulted in gross proceeds of $25.0 million. As of June 30,
2020, H&G own an aggregate of approximately 62% of the Company’s outstanding shares of Common Stock.
Master Services Agreement
Effective July 1, 2019, the Company
entered into a Master Services Agreement (“MSA”) with H&G whereby the Company agreed to assist H&G in an evaluation
of their long acting growth hormone program referred to as GX-H9. For the years ended June 30, 2020, the Company charged
H&G for employee services of $103,000 and reimbursable expenses incurred with unrelated parties of $144,000, for a total of
approximately $247,000. Amounts charged under the MSA for employee services are reflected as a reduction of research and development
compensation costs in the accompanying consolidated statement of operations for the year ended June 30, 2020.
Note
11 — SUPPLEMENTAL FINANCIAL INFORMATION
Interest and other income consist of the
following for the years ended June 30, 2020 and 2019 (in thousands):
2020
2019
Interest income
$ 188
$ 61
Gain on lease termination
-
168
Gain from change in fair value of embedded derivatives
-
74
Rental income
-
153
Total
$ 188
$ 456
Note
12 — Net Loss Per Share
Basic net loss per share is computed by
dividing net loss attributable to Common Stockholders by the weighted average number of common shares outstanding during the period.
The calculation of net loss attributable to Common Stockholders for the year ended June 30, 2019 reflects the BCF related
to the issuance of Series AA Preferred Stock to H&G discussed in Note 6, as follows (in thousands):
2020
2019
Net loss
$ (20,333 )
$ (30,446 )
Beneficial conversion feature
-
(2,273 )
Net loss attributable to common stockholders
$ (20,333 )
$ (32,719 )
For the years ended June 30, 2020
and 2019, basic and diluted net loss per share were the same since all Common Stock equivalents were anti-dilutive. As of June 30,
2020 and 2019, the following potential Common Stock equivalents were excluded from the computation of diluted net loss per share
since the impact of inclusion was anti-dilutive (in thousands):
50
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
2020
2019
Stock options
963
277
Warrants
618
920
Total
1,581
1,197
NOTE 13 — FINANCIAL INSTRUMENTS AND SIGNFICANT CONCENTRATIONS
Fair Value Measurements
Fair value is defined as the price that
would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants
on the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which
it transacts and considers assumptions that market participants would use when pricing the asset or liability. The Company applies
the following fair value hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization
within the hierarchy upon the lowest level of input that is available and significant to the fair measurement:
Level 1—Quoted prices
in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date.
Level 2—Other than quoted
prices included in Level 1 that are observable for the asset and liability, either directly or indirectly through market collaboration,
for substantially the full term of the asset or liability.
Level 3—Unobservable
inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing
for situations in which there is little, if any market activity for the asset or liability at measurement date.
Due
to the relatively short maturity of the respective instruments, t he fair value of cash and cash equivalents, accounts payable
and accrued liabilities approximated their carrying values as of June 30, 2020 and 2019. The Company did not have any other
assets and liabilities measured at fair value as of June 30, 2020 and 2019. The Company’s policy is to recognize asset
or liability transfers among Level 1, Level 2 and Level 3 as of the actual date of the events or change in circumstances that
caused the transfer. During the fiscal years ended June 30, 2020 and 2019, the Company had no transfers of its assets or
liabilities between levels of the fair value hierarchy.
Significant Concentrations
Financial instruments that subject the
Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains its cash and cash
equivalents at high-quality financial institutions. Cash deposits often exceed the amount of federal insurance provided on such
deposits. As of June 30, 2020 and 2019, the Company had cash and cash equivalents with a single financial institution with
a balance of $10.0 million and $11.6 million, respectively. The Company has never experienced any losses related to its investments
in cash and cash equivalents.
Note
14 — Subsequent Events
Related Party Licensing Agreement
On September 15, 2020, the Company
entered into an exclusive license agreement with Handok (the “Handok License”) for the territory of the Republic of
Korea. The Handok License relates to pharmaceutical products in final dosage form containing the pharmaceutical compounds developed
or to be developed by the Company, including those related to RZ358 and RZ402. The Handok License is in effect for a period of
20 years after the first commercial sale of each product, and requires (i) milestone payments of $0.5 million upon approval
of a New Drug Application (“NDA”) for each product in the territory, and (ii) the Company will sell products
ordered by Handok at a transfer price equal to 70% of the net selling price of the products. To date, no milestone payments have
been earned by the Company.
51
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Fiscal 2021 Financing
On September 15, 2020, the Company
entered into financial advisory agreements to undertake a private placement of equity or equity equivalent securities (the “Fiscal
2021 Financing”). Pursuant to the financial advisory agreements, the Company agreed to pay transaction fees to the financial
advisors for an aggregate of 6.0% of the gross proceeds plus out-of-pocket expenses. In addition, for any financing completed
within 60 days of the closing of the Fiscal 2021 Financing, the financial advisors are entitled to additional transaction fees
equal to 6.0% of the gross proceeds.
On
October 9, 2020, the Company completed the Fiscal 2021 Financing through the sale of units (the “Units”)
consisting of (i) approximately 2.5 million shares of Common stock, and (ii) warrants entitling the holders
to purchase approximately 0.8 million shares of Common Stock (the “Warrants”). The Warrants are exercisable at
$19.50 per share for a period of seven years and may be exercised on a cash or cashless basis at the election of the holders.
The Units were issued for a purchase price of $16.50 per Unit, resulting in gross proceeds of $41.0 million. Pursuant to the
financial advisory agreements, the Company paid transaction fees of $2.5 million, and costs for professional fees and other
offering costs are estimated at approximately $0.9 million. After deducting the financial advisory fees and other offering
costs, the estimated net proceeds amounted to approximately $37.6 million. Pursuant to the terms of the Fiscal 2021
Financing, the Company executed the Reverse Stock Split discussed in Note 1 and agreed to use commercially reasonable efforts
to enable trading of its Common Stock on the Nasdaq Capital Market. The Company effected a one share for 50 shares reverse
stock split on October 9, 2020. In addition, the Company entered into a registration rights agreement (“RRA”),
pursuant to which the Company agreed to use commercially reasonable efforts to register (i) the shares of Common Stock
included in the Units, and (ii) the shares of Common Stock issuable upon exercise of the warrants. If the Company fails
to register the shares pursuant to the terms of the RRA, liquidated damages up to a maximum of 6.0% of the gross proceeds of
the Fiscal 2021 Financing may be assessed.
Early Payments to Xoma
Upon completion of a qualified financing
of $20.0 million or more, the Company is obligated to repay the remaining outstanding balance due to Xoma within 15 days as discussed
in Note 4. The completion of the Fiscal 2021 Financing resulted in acceleration of the remaining balance due to Xoma of $1.8 million
as of June 30, 2020. The Company expects to make this payment to Xoma by October 2020.
Unaudited Pro Forma Disclosure
Presented below is an unaudited pro forma
balance sheet that gives effect to the Fiscal 2021 Financing and the Early Payments to Xoma, as if these events had occurred on
June 30, 2020 (in thousands, except per share amount):
52
REZOLUTE, INC.
Notes
to Consolidated Financial Statements
Equity Financing
Xoma
Gross
Offering
Early
Historical
Proceeds
(1)
Costs
(2)
Payments
(3)
Pro
Forma
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$ 9,955
$ 41,000
$ (3,420 )
$ (1,809 )
$ 45,726
Other current assets
563
-
-
-
563
Total current assets
10,518
41,000
(3,420 )
(1,809 )
46,289
Non-current assets:
Right-of-use assets, net
383
-
-
-
383
Other
64
-
-
-
64
Total assets
$ 10,965
$ 41,000
$ (3,420 )
$ (1,809 )
$ 46,736
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$ 893
$ -
$ -
$ -
$ 893
Accrued liabilities
488
-
-
-
488
Current portion of license fees payable to Xoma
1,600
-
-
(1,600 )
-
Current portion of operating lease liabilities
245
-
-
-
245
Total current liabilities
3,226
-
-
(1,600 )
1,626
Non-current liabilities:
License fees payable to Xoma, net of current portion
209
-
-
(209 )
-
Operating lease liabilities, net of current portion
165
-
-
-
165
Total liabilities
3,600
-
-
(1,809 )
1,791
Stockholders' equity:
Common
stock, $0.001 par value, 500,000 shares authorized; see below for outstanding shares
6
2
-
-
8
Additional paid-in capital
154,595
40,998
(3,420 )
-
192,173
Accumulated deficit
(147,236 )
-
-
-
(147,236 )
Total stockholders' equity
7,365
41,000
(3,420 )
-
44,945
Total liabilities and stockholders' equity
$ 10,965
$ 41,000
$ (3,420 )
$ (1,809 )
$ 46,736
Number of shares of Common Stock outstanding
5,867
2,485
-
-
8,352
(1) Gives
effect to the receipt of gross proceeds of $41.0 million on October 9, 2020, as
a result of the private placement of units at an issuance price of $16.50 per unit. The
units consisted of an aggregate of approximately 2.5 million shares of Common Stock and
warrants for the purchase of an additional 0.8 million shares of Common Stock.
(2) Gives
effect to the financial advisory fees of 6.0% of the gross proceeds and other estimated
offering costs of approximately $0.9 million related to the Fiscal 2021 Financing.
(3) Gives
effect to the requirement discussed in Note 4 to repay the remaining obligations due
to Xoma, since the Fiscal 2021 Financing met the definition of a qualified financing.
Bonuses for Certain Officers and Employees
On October 7, 2020, the Company's Board of Directors approved bonus payments for an aggregate
of $0.5 million to certain officers and employees. The bonuses are expected to be paid in October 2020.
53
ITEM 9. CHANGES IN AND DISAGREEMENTS
WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None
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