Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data.
TABLE OF CONTENTS
Page
Report of Independent Registered Public Accounting Firm ( Plante & Moran, PLLC ; Cleveland, Ohio ; PCAOB ID: 166 )
33
Financial Statements:
Consolidated balance sheets as of June 30, 2023 and 2022
34
Consolidated statements of operations and comprehensive loss for the fiscal years ended June 30, 2023 and 2022
35
Consolidated statements of shareholders’ equity for the fiscal years ended June 30, 2023 and 2022
36
Consolidated statements of cash flows for the fiscal years ended June 30, 2023 and 2022
37
Notes to consolidated financial statements
39
32
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors of Rezolute, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Rezolute, Inc. (the “Company”) as of June 30, 2023 and 2022, the related consolidated statements of operations, shareholders' equity, and cash flows for each of the years in the two-year period ended June 30, 2023, 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, 2023 and 2022, and the results of its operations and its cash flows for the years then ended, 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 audits, 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.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ Plante & Moran, PLLC
We have served as the Company’s auditor since 2013.
Cleveland, Ohio
September 14, 2023
33
Table of Contents
REZOLUTE, INC.
Consolidated Balance Sheets
June 30, 2023 and 2022
(In Thousands, Except Per Share Amounts)
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
16,036
$
150,410
Investments in marketable debt securities
85,860
—
Prepaid expenses and other
3,014
1,694
Total current assets
104,910
152,104
Long-term assets:
Investments in marketable debt securities
16,470
—
Right-of-use assets
2,054
152
Property and equipment, net
139
16
Deposits and other
148
148
Total assets
$
123,721
$
152,420
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable
$
3,269
$
1,132
Accrued liabilities:
Compensation and benefits
883
—
Accrued clinical and other
507
1,222
Current portion of operating lease liabilities
541
108
Total current liabilities
5,200
2,462
Long term liabilities:
Operating lease liabilities, net of current portion
1,937
80
Embedded derivative liabilities
412
407
Total liabilities
7,549
2,949
Commitments and contingencies (Notes 5 and 11)
Shareholders' equity:
Preferred stock, $ 0.001 par value; 400 shares authorized; no shares issued and outstanding
—
—
Common stock, $ 0.001 par value; 100,000 shares authorized; issued and outstanding 36,827 and 33,582 shares as of June 30, 2023 and 2022 , respectively
37
34
Additional paid-in capital
377,471
358,635
Accumulated other comprehensive loss
( 351 )
—
Accumulated deficit
( 260,985 )
( 209,198 )
Total shareholders’ equity
116,172
149,471
Total liabilities and shareholders’ equity
$
123,721
$
152,420
The accompanying notes are an integral part of these consolidated financial statements.
34
Table of Contents
REZOLUTE, INC.
Consolidated Statements of Operations and Comprehensive Loss
For the Fiscal Years Ended June 30, 2023 and 2022
(In Thousands, Except Per Share Amounts)
2023
2022
Operating expenses:
Research and development
$
43,813
$
32,486
General and administrative
12,177
9,357
Total operating expenses
55,990
41,843
Operating loss
( 55,990 )
( 41,843 )
Non-operating income (expense):
Interest and other income, net
4,208
80
Gain (loss) from change in fair value of derivative liabilities
( 5 )
6,545
Employee retention credit
—
231
Underwriting discount on issuance of derivative
—
( 2,495 )
Interest expense
—
( 1,807 )
Loss on extinguishment of loan agreement
—
( 1,771 )
Total non-operating income (expense), net
4,203
783
Net loss
( 51,787 )
( 41,060 )
Other comprehensive loss:
Net unrealized loss on available-for-sale marketable debt securities
( 351 )
—
Comprehensive loss
$
( 52,138 )
$
( 41,060 )
Net loss per common share:
Basic
$
( 1.01 )
$
( 2.26 )
Diluted
$
( 1.01 )
$
( 2.32 )
Weighted average number of common shares outstanding:
Basic
51,187
18,197
Diluted
51,187
19,487
The accompanying notes are an integral part of these consolidated financial statements.
35
Table of Contents
REZOLUTE, INC.
Consolidated Statements of Shareholders’ Equity
For the Fiscal Years Ended June 30, 2023 and 2022
(In Thousands)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Shareholders'
Shares
Amount
Capital
Loss
Deficit
Equity
Balances, June 30, 2021
8,352
$
8
$
194,229
$
—
$
( 168,138 )
$
26,099
Proceeds from issuance of equity securities for cash in 2022 Registered Direct Offering, net of discounts:
Common stock
18,026
18
64,372
—
—
64,390
Class A pre-funded warrants
—
—
7,048
—
—
7,048
Gross proceeds from issuance of equity securities for cash in Underwritten Public Offering:
Common stock
6,147
6
39,950
—
—
39,956
2021 pre-funded warrants
—
—
10,783
—
—
10,783
Gross proceeds from issuance of common stock for cash:
In 2021 Registered Direct Offering
769
1
4,999
—
—
5,000
Under Equity Distribution Agreement
138
1
1,518
—
—
1,519
Under LPC Purchase Agreement
116
—
1,172
—
—
1,172
Underwriting commissions and other equity offering costs
—
—
( 4,596 )
—
—
( 4,596 )
Share-based compensation
—
—
3,685
—
—
3,685
Reclassification of Class B pre-funded warrant derivative liability to equity upon cure of authorized share deficiency
—
—
35,025
—
—
35,025
Commitment shares issued under LPC Purchase Agreement
34
—
450
—
—
450
Net loss
—
—
—
—
( 41,060 )
( 41,060 )
Balances, June 30, 2022
33,582
$
34
$
358,635
$
—
$
( 209,198 )
$
149,471
Gross proceeds from issuance of equity securities for cash in 2022 Private Placement
3,245
3
12,327
—
—
12,330
Underwriting discounts and other equity offering costs
—
—
( 759 )
—
—
( 759 )
Share-based compensation
—
—
7,268
—
—
7,268
Net change in other accumulated comprehensive loss
—
—
—
( 351 )
—
( 351 )
Net loss
—
—
—
—
( 51,787 )
( 51,787 )
Balances, June 30, 2023
36,827
$
37
$
377,471
$
( 351 )
$
( 260,985 )
$
116,172
The accompanying notes are an integral part of these consolidated financial statements.
36
Table of Contents
REZOLUTE, INC.
Consolidated Statements of Cash Flows
For the Fiscal Years Ended June 30, 2023 and 2022
(In Thousands)
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 51,787 )
$
( 41,060 )
Share-based compensation expense
7,268
3,685
Non-cash lease expense
352
243
Loss from change in fair value of derivative liabilities
5
—
Accretion of discounts and amortization of premiums on marketable debt securities, net
( 1,370 )
—
Depreciation and amortization expense
30
13
Gain from change in fair value of derivative liabilities, net
—
( 6,545 )
Underwriting discount on issuance of derivative
—
2,495
Loss on extinguishment of Loan Agreement:
Prepayment premium paid
—
300
Other
—
1,471
Accretion of debt discount and issuance costs
—
424
Changes in operating assets and liabilities:
Increase in prepaid expenses and other assets
( 1,320 )
( 860 )
Increase (decrease) in accounts payable
2,136
( 11 )
Increase in accrued liabilities
205
229
Net Cash Used in Operating Activities
( 44,481 )
( 39,616 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of marketable debt securities
( 107,311 )
—
Proceeds from maturities of marketable debt securities
6,000
—
Purchase of property and equipment
( 153 )
—
Total Cash Used in Investing Activities
( 101,464 )
—
CASH FLOWS FROM FINANCING ACTIVITIES:
Gross proceeds from issuance of common stock for cash:
2022 Private Placement
12,330
—
2021 Registered direct offering
—
5,000
Under Equity Distribution Agreement
—
1,519
Under LPC Purchase Agreement
—
1,172
Gross proceeds from 2022 Registered Direct Offering, net of underwriting discounts:
Issuance of common stock
—
64,390
Issuance of Class A pre-funded warrants
—
7,048
Issuance of Class B pre-funded warrants
—
39,094
Gross proceeds from 2021 Underwritten Offering:
Common stock
—
39,956
2021 pre-funded warrants
—
10,783
Payment of commissions and other offering costs
( 759 )
( 3,716 )
Payment of debt discount and issuance costs
—
( 254 )
Prepayment of contractual obligations under Loan Agreement, including prepayment fee
—
( 16,013 )
Net Cash Provided by Financing Activities
11,571
148,979
Net (decrease) increase in cash, cash equivalents and restricted cash
( 134,374 )
109,363
Cash, cash equivalents and restricted cash at beginning of period
150,410
41,047
Cash, cash equivalents and restricted cash at end of period
$
16,036
$
150,410
37
Table of Contents
The accompanying notes are an integral part of these consolidated financial statements.
REZOLUTE, INC.
Consolidated Statements of Cash Flows, Continued
For the Fiscal Years Ended June 30, 2023 and 2022
(In Thousands)
2023
2022
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:
Cash and cash equivalents, end of year
$
16,036
$
150,410
Restricted cash, end of year
—
—
Total cash, cash equivalents and restricted cash, end of year
$
16,036
$
150,410
SUPPLEMENTARY CASH FLOW INFORMATION:
Cash paid for interest
$
—
$
1,487
Cash paid for income taxes
—
—
Cash paid for amounts included in the measurement of operating lease liabilities
215
254
Operating lease liabilities incurred in exchange for right-of-use assets
2,204
—
NON-CASH INVESTING AND FINANCING ACTIVITIES:
Reclassification of derivative liabilities to equity upon cure of authorized share deficiency
$
—
$
35,025
Issuance of commitment shares for deferred offering costs subsequently charged to additional paid-in capital
—
450
Payables for deferred offering costs subsequently charged to additional paid-in capital
—
61
The accompanying notes are an integral part of these consolidated financial statements.
38
Table of Contents
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 developing transformative therapies for metabolic diseases related to chronic glucose imbalance.
Consolidation
The Company has two wholly owned subsidiaries consisting of Rezolute (Bio) Ireland Limited, and Rezolute Bio UK, Ltd. The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
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”).
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 shareholders’ equity instead of net income (loss). For the fiscal year ended June 30, 2023, components of comprehensive loss included the Company’s net loss and unrealized gains (losses) on investments in marketable debt securities. For the fiscal year ended June 30, 2022, the only component of comprehensive loss was the Company’s net loss as the Company had no items constituting any other comprehensive income (loss).
The Company’s Chief Executive Officer also serves as the Company’s chief operating decision maker 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, determination if other than temporary impairment exists for marketable debt securities, the fair value of derivative liabilities, fair value of share-based payments and warrants, management’s assessment of going concern, and clinical trial accrued liabilities. Actual results could differ from those estimates.
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 discussed in Note 2.
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
39
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
consist primarily of demand deposits with financial institutions, money market funds and corporate commercial paper purchased with a maturity of three months or less.
Investments in Marketable Debt Securities
Under the investment policy approved by the Company’s Board of Directors, eligible investments in fixed income debt securities must be denominated and payable in U.S. dollars, including eligible corporate bonds, corporate commercial paper, U.S. government obligations, and money market funds. This investment policy only permits investments in the debt securities of issuers that meet stringent credit quality ratings on the date of the investment. The investment policy also places restrictions on the length of maturities and concentrations by type and issuer. The Company’s investments are issued by financial institutions that management believes are of high credit quality. However, they are exposed to credit risk in the event of default by the issuers. The Company classifies investments in marketable debt securities that mature in less than one year as short-term assets. For investments that mature in more than one year, the investments are classified as long-term assets unless management intends to liquidate the investments to fund current operations before the scheduled maturity dates.
The Company accounts for its investments in marketable debt securities as available-for-sale securities whereby they are recorded in the consolidated balance sheet at fair value. Interest income is recognized in the consolidated statement of operations, consisting of accrued interest earned based on the coupon rate of the security, plus the impact of accreting discounts and amortizing premiums to maturity using the straight-line method which approximates the interest method. Unrealized gains and losses due to subsequent changes in fair value of the investments are reported in shareholders’ equity as a component of accumulated other comprehensive income (loss). The Company reviews the components of its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below amortized cost have resulted from a credit-related loss or other factors. If declines in fair value are due to a deterioration of credit quality of the issuer, the Company recognizes (i) a loss in other comprehensive income (loss) if the reduction in fair value is considered temporary, or (ii) a loss in the consolidated statement of operations if the reduction in fair value is considered other than temporary. For a decline in fair value that is solely due to changes in interest rates, impairment is not recognized if the Company has the ability and intent to hold the investment until maturity. The cost basis of any securities sold prior to maturity will be determined using the specific identification method.
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 to determine 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 consist solely of office furniture and equipment that is recorded at cost. Depreciation expense is calculated using the straight-line method over the estimated useful lives of the assets which range from 3 to 5 years . Maintenance and repairs are expensed as incurred.
40
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Debt Discounts and Issuance Costs
Debt discounts and issuance costs (“DDIC”) incurred to obtain new debt financings or modify existing debt financings consist of incremental direct costs incurred for fees paid to the lender, professional fees and due diligence services. DDIC is presented as a reduction in the carrying value of the debt and is accreted to interest expense using the effective interest method.
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.
Share-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 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 share-based compensation. For stock options that are voluntarily surrendered by employees, all unrecognized compensation is immediately recognized in the period the options are cancelled.
For stock options with vesting that is dependent on achieving certain market, performance and service conditions (“Hybrid Options”), the Company recognizes compensation expense over the requisite service period beginning on the date when the performance condition is considered probable of occurrence. 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. If the Hybrid Options do not ultimately become exercisable due to the failure of the option holder to achieve the requisite service period, any previously recognized compensation cost is reversed. However, if the Hybrid Options do not ultimately become exercisable due to the failure to achieve the market condition, previously recognized compensation cost will not be reversed.
Embedded 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 would meet the definition of a derivative instrument, and if so whether the features are considered clearly and closely related to the primary economic
41
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
characteristics 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 shareholders’ equity, then the embedded feature is bifurcated from the Host Contract and accounted for as a derivative liability. 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.
Governmental Assistance
In response to the COVID-19 pandemic, the United States government designed programs to assist businesses in dealing with the financial hardships caused by the pandemic. The Company recognizes the right to receive governmental assistance payments in the period in which all necessary legal requirements have been met and other related conditions on which they depend are substantially met.
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 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 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.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of outstanding shares of common stock and pre-funded warrants that are accounted for as equity instruments. Common shares associated with pre-funded warrants are included in the computation of both basic and diluted net loss per share since the exercise price is negligible and all of the pre-funded warrants are fully vested and exercisable. To the extent dilutive, during periods in which pre-funded warrants are accounted for as derivative liabilities, the calculation of diluted net loss per share is further adjusted to eliminate gains on changes in the fair value of such pre-funded warrants, net of related discounts upon issuance, and the related pre-funded warrant shares are included in the weighted average number of shares outstanding
Diluted net loss per share is computed using the treasury stock method by further giving effect to all potential shares of common stock, including stock options and warrants, to the extent dilutive.
For participating warrants that are entitled to participate in dividend to holders of shares of common stock, the Company applies the two-class method of allocating earnings if the impact is dilutive for the calculation of both basic and diluted net loss per share.
42
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Recent Accounting Pronouncements
Recently Adopted Accounting Standard. The following accounting standard was adopted in the fiscal year ended June 30, 2023:
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). ASU 2020-06 reduces the number of accounting models for convertible debt instruments and convertible preferred stock, which results in fewer embedded conversion features being separately recognized from the host contract as compared with current GAAP. Additionally, ASU 2020-06 affects the diluted earnings per share calculation for instruments that may be settled in cash or shares and for convertible instruments and requires enhanced disclosures about the terms of convertible instruments and contracts in an entity’s own equity. ASU 2020-06 allows entities to use a modified or full retrospective transition method and is effective for smaller reporting companies for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company adopted this standard using the full retrospective transition method effective July 1, 2022. The adoption did not have any impact on the Company’s consolidated financial statements.
Standards Required to be Adopted in Future Years. The following accounting standard is not yet effective but will be adopted effective on July 1, 2023:
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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. ASU 2016-13 will be implemented during the fiscal quarter ending September 30, 2023 and will impact the Company’s evaluation of impairment of investments in marketable debt securities. 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 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, 2023, the Company incurred a net loss of $ 51.8 million and net cash used in operating activities amounted to $ 44.5 million. As of June 30, 2023, the Company had an accumulated deficit of $ 261.0 million, and the Company’s capital resources consisted of cash and cash equivalents of $ 16.0 million, short-term investments in marketable debt securities of $ 85.9 million and long-term investments in marketable debt securities of $ 16.5 million.
As of June 30, 2023, the Company had total liabilities of $ 7.5 million, including total current liabilities of $ 5.2 million. As discussed in Note 5, the Company is subject to license agreements that provide for future contractual payments upon achievement of various milestone events. Pursuant to the XOMA License Agreement (as defined below), a $ 5.0 million milestone payment will be due upon dosing of the first patient in a Phase 3 clinical trial for RZ358. First patient dosing milestone for the RZ358 Phase 3 clinical trial is expected to occur within the next 12 months.
43
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Management believes the Company’s cash and cash equivalents and investments in marketable securities will be adequate to meet the Company’s contractual obligations and carry out ongoing clinical trials and other planned activities through September 2024, at a minimum.
NOTE 3 — INVESTMENTS IN MARKETABLE DEBT SECURITIES
The estimated fair value of investments in marketable debt securities are classified as follows in the consolidated balance sheet as of June 30, 2023 (in thousands):
2023
Short-term investments
$
85,860
Long-term investments
16,470
Total investments
$
102,330
The Company only invests in liquid, high quality debt securities. However, all of these investments are subject to interest rate and credit risk that may result in fluctuations in the fair value of the investments. To minimize the exposure due to an adverse shift in interest rates, the Company generally invests in securities with expected maturities of two years or less and maintains a weighted average maturity of one year or less. As of June 30, 2023 investments in marketable debt securities with a fair value of $ 85.9 million are scheduled to mature during the 12-month period ending June 30, 2024 and substantially all of the remaining investments with a fair value of $ 16.5 million, are scheduled to mature during the 12-month period ending June 30, 2025.
During the fiscal year ended June 30, 2023, no securities classified as available-for-sale were sold and the only redemptions occurred were as a result of the maturity of the respective investments. During the fiscal year ended June 30, 2022, the Company did not have any investments in marketable debt securities.
Accrued interest receivable on all marketable debt securities amounted to $ 0.3 million which is included in other current assets in the accompanying consolidated balance sheet as of June 30, 2023.
The following table summarizes the unrealized gains and losses that result in differences between the amortized cost basis and fair value of the Company’s marketable debt securities held as of June 30, 2023 (in thousands):
Gross Unrealized
Amortized Cost
Gains
Losses
Fair Value
Corporate commercial paper
$
41,670
$
—
$
( 73 )
$
41,597
Obligations of U.S. government agencies
26,565
—
( 170 )
26,395
U.S. Treasury obligations
10,416
2
( 14 )
10,404
Corporate notes and bonds
19,253
1
( 14 )
19,240
Asset-backed securities
4,777
—
( 83 )
4,694
Available-for-sale investments
$
102,681
$
3
$
( 354 )
$
102,330
NOTE 4 — LEASES
In April 2022, the Company entered into a lease agreement for a new corporate headquarters in Redwood City, California. The space consists of approximately 9,300 square feet and provides for total base rent payments of approximately $ 2.9 million through the expected expiration of the lease in November 2027. Prior to occupancy, the landlord was required to make improvements to the facility that were completed in October 2022, triggering the commencement of the lease. The lease provided for a six-month rent abatement period beginning upon commencement of the lease term. In addition, the lease provided an allowance of approximately $ 0.1 million that was utilized by the Company for the purchase of furniture and equipment. The average base rent payable in cash over the 60-month lease term is approximately $ 48,000 per month.
44
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Upon commencement of the lease, the Company recognized a right-of-use asset for approximately $ 2.3 million, and a related operating lease liability for approximately $ 2.2 million.
As of June 30, 2023 and 2022, the carrying values of all of the Company’s right-of-use assets and operating lease liabilities were as follows (in thousands):
2023
2022
Right-of-use assets
$
2,054
$
152
Operating lease liabilities:
Current
$
541
$
108
Long-term
1,937
80
Total
$
2,478
$
188
For the fiscal years ended June 30, 2023 and 2022, operating lease expense was as follows (in thousands):
2023
2022
Research and development
$
453
$
289
General and administrative
154
103
Total
$
607
$
392
As of June 30, 2023, the weighted-average remaining lease term under operating leases was 4.3 years, and the weighted-average discount rate used to determine the operating lease liabilities was 6.8 %.
Future Lease Payments
Future payments under operating lease agreements as of June 30, 2023 are as follows (in thousands):
Fiscal year ending June 30,
2024
$
689
2025
627
2026
646
2027
666
Thereafter
224
Total lease payments
2,852
Less imputed interest
( 374 )
Present value of operating lease liabilities
$
2,478
NOTE 5 —LICENSE AGREEMENTS
XOMA License Agreement
In December 2017, the Company entered into a license agreement (“XOMA License Agreement”) with XOMA Corporation (“XOMA”), through its wholly-owned subsidiary, XOMA (U.S.) 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.
45
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
In January 2022, the Company was required to make a milestone payment under the XOMA License Agreement of $ 2.0 million that became due upon the dosing of the last patient in the Company’s ongoing Phase 2b Clinical Trial for RZ358. Upon the achievement of certain clinical and regulatory events under the XOMA License Agreement, the Company will be required to make additional milestone payments to XOMA up to $ 35.0 million. After the clinical and regulatory milestones, the Company will be required, upon the future commercialization of RZ358, to pay royalties to XOMA based on the net sales of the related products and additional milestone payments to XOMA up to $ 185.0 million related to annual net sales amounts. There have been no events that would result in any royalty payments owed under the XOMA License Agreement to date. The next milestone payment of $ 5.0 million will be due upon dosing of the first patient in a Phase 3 clinical trial for RZ358.
ActiveSite License Agreement
In August 2017, the Company entered into a Development and License Agreement (the “ActiveSite 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 Development and License Agreement requires various milestone payments up to $ 46.5 million if all milestone events are achieved. The first milestone payment for $ 1.0 million was paid in December 2020 after clearance was received for an Initial Drug Application, or IND, filed with the U.S. Food and Drug Administration (“FDA”). The second milestone payment of $ 3.0 million was paid in February 2023 after dosing of the first patient in a Phase 2 clinical trial for RZ402. The next milestone payment of $ 5.0 million will be due upon the first dosing of a patient in a Phase 3 clinical trial. The Company is also required to pay royalties equal to 2.0 % of any sales of products that use the PKI Portfolio. There have been no events that would result in any royalty payments owed under the ActiveSite License Agreement to date.
NOTE 6 — EMBEDDED DERIVATIVE LIABILITY
On April 14, 2021, the Company entered into a $ 30.0 million Loan and Security Agreement (the “Loan Agreement”) with SLR Investment Corp. (“SLR”) and certain other lenders (collectively, the “Lenders”). The Lenders agreed to loan up to $ 30.0 million but the actual amount borrowed by the Company amounted to $ 15.0 million. The maturity date of the outstanding borrowings was April 1, 2026 (the “Maturity Date”), but the Company elected to repay the entire amount and terminated the Loan Agreement on June 30, 2022. Accordingly, the Company paid a total of $ 16.0 million consisting of the outstanding principal of $ 15.0 million, the Final Fee of $ 0.7 million and the prepayment fee of $ 0.3 million. As of June 30, 2022, a loss on extinguishment of the Loan Agreement of $ 1.8 million was recognized for the unaccreted discount of $ 1.5 million and the 2.00 % prepayment penalty of $ 0.3 million.
Concurrently with the execution of the Loan Agreement, the Company entered into an exit fee agreement (the “Exit Fee Agreement”) that provides for a fee of 4.00 % of the funded principal balance for a total of $ 0.6 million in the event certain transactions (defined as “Exit Events”) occur prior to April 13, 2031. The Exit Fee was not impacted by termination of the Loan Agreement discussed above. The Company is accounting for the Exit Fee Agreement as an embedded derivative liability with an estimated fair value of $ 0.4 million as of June 30, 2023 and 2022. Exit Events include, but are not limited to, sales of substantially all assets, certain mergers, change of control transactions, and issuances of common stock that result in new investors owning more than 35 % of the Company’s shares. Fair value of embedded derivatives is assessed at the end of each reporting period with changes in fair value recognized as a nonoperating gain or loss.
NOTE 7 — DERIVATIVE LIABILITY FOR AUTHORIZED SHARE DEFICIENCIES
As discussed in Note 8, the Company completed an underwritten offering in May 2022 that resulted in the issuance of 10,947,371 Class B pre-funded warrants (“Class B PFWs”) for gross proceeds of approximately $ 41.6 million or $ 3.80 per share. Exercisability of the Class B PFWs was subject to the Company’s ability to obtain shareholder approval for an
46
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
increase in authorized shares. Since the ability to obtain shareholder approval was outside the Company’s control, liability classification was required beginning on the date of issuance of the Class B PFWs on May 4, 2022.
The fair value of approximately $ 41.6 million related to the Class B PFWs on the date of issuance was accounted for as a derivative liability beginning on May 4, 2022. As discussed in Note 8, the Company’s shareholders approved an increase in authorized shares from 40.0 million shares to 100.0 million shares on June 16, 2022. Upon receipt of shareholder approval for the authorized share increase, fair value of the derivative liability had decreased to $ 35.0 million or $ 3.20 per share, which resulted in a gain of $ 6.6 million. This gain is included in non-operating income and the derivative liability of $ 35.0 million was reclassified into shareholders’ equity on June 16, 2022. Underwriter discounts of approximately $ 2.5 million related to the Class B PFWs were expensed on the date of issuance since the fair value of the Class B PFWs exceeded the net proceeds received by the Company. Fair value of the Class B PFWs was determined using the BSM option-pricing model with the following assumptions as of June 16, 2022:
Market price of common stock
$
3.20
Exercise price
$
0.001
Risk-free interest rate
3.3
%
Dividend rate
0.0
%
Remaining expected term (years)
9.9
Historical volatility
95.0
%
NOTE 8 — SHAREHOLDERS’ EQUITY
Changes in Authorized Capital Stock
On June 16, 2022, the Company’s shareholders approved an increase of authorized shares from 40.0 million shares to 100.0 million shares of common stock. Accordingly, as of June 30, 2023 and 2022, the Company was authorized to issue 100.0 million shares of common stock and 0.4 million shares of preferred stock.
May 2022 Registered Direct Offering
On May 1, 2022, the Company entered into (i) an underwriting agreement with Jefferies LLC, as representative of the underwriters listed therein, relating to the issuance and sale of equity securities in an underwritten registered direct offering (the “2022 RDO”), and (ii) a placement agency agreement with Jefferies LLC, that provided for a private placement of equity securities (the “2022 Private Placement”). The 2022 RDO resulted in the issuance of (i) approximately 18.0 million shares of the Company’s common stock, at a public offering price of $ 3.80 per share, (ii) Class A pre-funded warrants (the “Class A PFWs”) to purchase up to approximately 2.0 million shares of common stock at a public offering price of $ 3.799 per Class A PFW and (iii) Class B PFWs to purchase up to 10.9 million shares of common stock at a public offering price of $ 3.799 per Class B PFW. The gross amount of the 2022 RDO was $ 117.6 million, before deducting an aggregate of $ 7.1 million incurred for underwriting discounts and approximately $ 0.4 million for professional fees and other offering expenses payable by the Company. The 2022 RDO closed on May 4, 2022 and the Company received net proceeds of approximately $ 110.5 million. In connection with the 2022 RDO, certain of the Company’s officers and directors agreed not to sell or otherwise dispose of any common stock held by them through July 30, 2022.
2022 Private Placement
Pursuant to the 2022 Private Placement, the Company entered into a securities purchase agreement (“SPA”) on May 4, 2022 with Handok, Inc. (“Handok”), an entity affiliated with a member of the Board of Directors, and certain of Handok’s affiliates (collectively, the “Purchasers”). Contingent upon satisfaction of certain closing conditions set forth in the SPA, the Company agreed to sell to the Purchasers 3.2 million shares of common stock at a price of $ 3.80 per share. In July 2022 the Company entered into amended SPAs for the 2022 Private Placement resulting in gross proceeds of approximately $ 12.3 million in exchange for approximately 3.2 million shares of common stock. The Company incurred
47
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
approximately $ 0.8 million for underwriting commissions and other offering costs resulting in net proceeds of $ 11.6 million.
2022 Pre-Funded Warrants
The offering price of $ 3.799 per share for the Class A PFWs and the Class B PFWs (collectively, the “2022 PFWs”) is equal to the public offering price for the shares of common stock issued in the 2022 RDO less the $ 0.001 per share price that is required to be paid to the Company upon exercise of the 2022 PFWs. The exercise price of the 2022 PFWs is subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock, and also upon any distributions for no consideration of assets to the Company's shareholders. In the event of certain corporate transactions, the holders of the 2022 PFWs will be entitled to receive, upon exercise of the 2022 PFWs, the kind and amount of securities, cash or other property that the holders would have received had they exercised the 2022 PFWs immediately prior to such transaction. The 2022 PFWs do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of common stock are entitled.
Each Class A PFW is exercisable upon issuance. The Class B PFWs became exercisable for shares of common stock upon receipt of shareholder approval for an increase in the number of authorized shares of common stock as discussed below under the caption Required Shareholder Approval . As of June 30, 2023, none of the 2022 PFWs have been exercised.
Required Shareholder Approval
The closing of the 2022 RDO resulted in the issuance of approximately 18.0 million shares of common stock and Class A PFWs exercisable for approximately 2.0 million shares. After these issuances, the Company had utilized the entire 40.0 million of authorized shares of common stock that were available under its corporate charter, consisting of issued shares and shares of common stock reserved for issuance under stock option plans and outstanding warrants. Accordingly, the Company did not have a sufficient number of shares of common stock available to permit exercise of any of the Class B PFWs. Accordingly, the Class B PFWs were only exercisable for shares of common stock to the extent that shareholders subsequently approved an increase in the number of authorized shares (the “Shareholder Approval”), which the Company was required to use its best efforts to obtain at an annual meeting of shareholders to be held by June 30, 2022. As noted under the caption Changes in Authorized Capital Stock the Company obtained shareholder approval for an increase of authorized shares on June 16, 2022. As of June 30, 2023, the 10.9 million Class B PFWs issued were fully exercisable and no shares underlying the Class B PFWs had been exercised.
Upon closing of the 2022 RDO on May 4, 2022, the Company accounted for the gross proceeds of $ 41.6 million received from the issuance of the Class B PFWs as a derivative liability. As a result of subsequent reductions in the fair value of this derivative liability, the Company recognized a gain of $ 6.6 million through June 16, 2022 when Shareholder Approval was obtained. Upon receipt of Shareholder Approval for the increase in authorized shares to 100.0 million shares, the Company reclassified the related Class B PFW derivative liability of $ 35.0 million to shareholders’ equity.
Registration Rights Agreement
In connection with the offer of the Class B PFWs, the Company entered into registration rights agreements with the purchasers. As required by the registration rights agreements, the Company filed a registration statement in June 2022 that was declared effective on July 1, 2022 to register the shares issuable upon exercise of the Class B PFWs. If the Company fails to comply with the registration rights agreement, it will be obligated to pay 2.0 % of the purchase price of the Class B PFWs for an aggregate of approximately $ 0.8 million as liquidated damages. If liquidated damage payments are required in the future, they will be charged to expense in the period incurred.
2021 Underwritten Public Offering
On October 12, 2021, the Company entered into an underwriting agreement with Oppenheimer & Co., Inc., as representative of the underwriters listed therein (the “2021 Underwriters”) for the planned issuance and sale of equity
48
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
securities in an underwritten public offering (the “2021 Underwritten Offering”). On October 15, 2021, closing occurred for the Underwritten Offering resulting in the issuance of (i) 6,030,847 shares of common stock at $ 6.50 per share for gross proceeds of $ 39.2 million, and (ii) 1,661,461 pre-funded warrants to purchase 1,661,461 shares of common stock at an issuance price of $ 6.49 per warrant (the “2021 PFWs”) for gross proceeds of $ 10.8 million. The aggregate gross proceeds from the Underwritten Offering amounted to $ 50.0 million, excluding the Underwriters’ Option discussed below, and before deductions for underwriting commissions of 6.0 % of the gross proceeds and other offering costs of approximately $ 0.3 million. After deducting total offering costs of $ 3.3 million, the net proceeds of the Underwritten Offering amounted to approximately $ 46.7 million.
The Company granted the 2021 Underwriters a 30-day option to purchase up to an additional 1,153,845 shares of its common stock in the 2021 Underwritten Offering at a public offering price of $ 6.50 per share, less underwriting commissions (the “Underwriters’ Option”). In November 2021, the Underwriters’ Option was partially exercised for 116,266 shares resulting in gross proceeds of approximately $ 0.8 million.
2021 Pre-Funded Warrants
The 2021 PFWs have an exercise price of $ 0.01 per share, which is subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock. Each 2021 PFW is exercisable at any time and from time to time after issuance with no stated expiration date. In the event of certain corporate transactions, the holders of the 2021 PFWs will be entitled to receive, upon exercise of the 2021 PFWs, the kind and amount of securities, cash or other property that the holders would have received had they exercised the 2021 PFWs immediately prior to such transaction. The 2021 PFWs do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of common stock are entitled.
The gross proceeds of $ 10.8 million received from issuance of the 2021 PFWs was recorded as a component of shareholders’ equity within additional paid-in capital. In accordance with the terms of the warrant agreement, holders of the outstanding warrants are not entitled to exercise any portion of the 2021 PFWs if, upon exercise of such portion of the warrant, the holder’s aggregate ownership of the Company’s common stock or the combined voting power beneficially owned by such holder would exceed a designated percentage elected by the holder ranging from 4.99 % to 19.99 %, after giving effect to the exercise (the “Maximum Ownership Percentage”). Upon at least 61 days ’ prior notice to the Company, any warrant holder may elect to increase or decrease the Maximum Ownership Percentage to any other percentage not to exceed 19.99 %. Through June 30, 2023, no shares underlying the 2021 PFWs have been exercised.
2021 Registered Direct Offering
Concurrently with the Underwritten Offering, Handok entered into a subscription agreement for a registered direct offering (the “2021 RDO”) pursuant to which the Company agreed to sell Handok an aggregate of 769,231 shares of its common stock at a purchase price of $ 6.50 per share. The closing for the 2021 RDO occurred on October 27, 2021, whereby the Company received gross proceeds of $ 5.0 million.
Termination of EDA and Purchase Agreement
The Company entered an Equity Distribution Agreement (“EDA”) with Oppenheimer & Co. Inc. (“Oppenheimer”) in December 2020 and a purchase agreement (“Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”) in August 2021. The Company sold 138,388 shares of its common stock pursuant to the EDA for net proceeds of approximately $ 1.5 million. From August 2021 through September 2021, LPC purchased 115,708 shares of common stock for gross proceeds of approximately $ 1.2 million. Concurrently, the Company issued 33,799 shares of common stock to LPC as an initial fee for its commitment to purchase shares under the Purchase Agreement. In May 2022, the Company provided notices to Oppenheimer and LPC whereby the EDA and the Purchase Agreement were terminated. As a result of these termination notices, no further equity securities are issuable under either agreement.
49
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
NOTE 9 — SHARE-BASED COMPENSATION AND WARRANTS
Stock Option Plans
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 as of June 30, 2023 (in thousands):
Plan Termination
Number of Shares
Description
Date
Authorized
Outstanding
Available
2015 Plan
February 2020
17
17
—
2016 Plan
October 2021
140
140
—
2019 Plan
July 2029
200
200
—
2021 Plan
March 2031
10,700
8,388
2,312
Total
11,057
8,745
2,312
The Company currently has one active stock option plan, the 2021 Equity Incentive Plan (the “2021 Equity Plan”). On March 31, 2021, the Company’s Board of Directors adopted the 2021 Equity Plan that will terminate on March 31, 2031. On May 26, 2021, the 2021 Equity plan was approved by the Company’s shareholders with authority to issue up to 1.2 million shares of common stock. Pursuant to the 2021 Equity Plan, no awards may be granted under the three legacy stock option plans shown in the table above, but all outstanding awards previously granted under those plans shall remain outstanding and subject to the terms of the respective plans. On June 16, 2022, the Company’s shareholders approved an amendment to the 2021 Equity Plan, increasing the number of shares of common stock to be issued under the plan up to 10.7 million shares of common stock. Stock options outstanding under these plans expire pursuant to their contractual provisions on various dates through 2033.
2022 Employee Stock Purchase Plan
On June 16, 2022, the Company’s shareholders approved the adoption of the 2022 Employee Stock Purchase Plan (the “2022 ESPP”). The 2022 ESPP provides an opportunity for employees to purchase shares of the Company’s common stock through accumulated payroll deductions.
50
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
The 2022 ESPP has consecutive offering periods that begin approximately every 6 months commencing on the first trading day on or after July 1 and terminating on the last trading day of the offering period ending on December 31 and commencing on the first trading day on or after January 1 and terminating on the last trading day of the offering period ending on June 30. The 2022 ESPP reserves 0.5 million shares for purchases. There have been no offering periods under the 2022 ESPP through June 30, 2023.
Stock Options Outstanding
The following table sets forth a summary of the combined activity under all of the Company’s stock option plans for the fiscal years ended June 30, 2023 and 2022 (shares in thousands):
2023
2022
Shares
Price (1)
Term (2)
Shares
Price (1)
Term (2)
Outstanding, beginning of fiscal year
8,506
$
5.24
9.7
1,285
$
16.35
8.7
Grants to employees
740
2.00
7,373
3.51
Expired
( 116 )
40.73
( 78 )
19.03
Forfeited
( 385 )
3.75
( 74 )
9.72
Outstanding, end of fiscal year
8,745
4.56
8.8
8,506
5.24
9.7
Vested, end of fiscal year
2,676
6.57
8.4
685
18.63
7.5
(1) Represents the weighted average exercise price.
(2) Represents the weighted average remaining contractual term until the stock options expire.
For the fiscal year ended June 30, 2023, the aggregate fair value of stock options granted for approximately 0.7 million shares of common stock amounted to $ 1.1 million or approximately $ 1.53 per share as of the grant dates. For the fiscal year ended June 30, 2022, the aggregate fair value of stock options granted for approximately 7.4 million shares of common stock amounted to $ 20.1 million or approximately $ 2.72 per share as of the grant dates. 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. The fair value of stock options was estimated on the dates of grant using the BSM option-pricing model, with the following weighted-average assumptions for the fiscal years ended June 30, 2023 and 2022:
2023
2022
Market price of common stock on grant date
$
3.73
$
3.51
Expected volatility
91
%
94
%
Risk free interest rate
3.7
%
3.1
%
Expected term (years)
6.0
6.1
Dividend yield
0
%
0
%
Share-based compensation expense is included under the following captions in the consolidated statements of operations for the fiscal years ended June 30, 2023 and 2022 (in thousands):
2023
2022
Research and development
$
3,243
$
1,405
General and administrative
4,025
2,280
Total
$
7,268
$
3,685
51
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Unrecognized share-based compensation expense for stock options that provide solely for time-based vesting as of June 30, 2023 was approximately $ 16.9 million. This amount is expected to be recognized over a remaining weighted average period of 2.8 years. As of June 30, 2023, unrecognized compensation of $ 0.1 million related to the remaining Hybrid Options is being recognized ratably over a weighted average period of 1.1 years.
Pre-Funded Warrants
In connection with the 2021 RDO discussed in Note 8, the Company issued 2021 PFWs to purchase 1,661,461 shares of common stock at an issuance price of $ 6.49 per warrant for gross proceeds of $ 10.8 million. The 2021 PFWs may be exercised at any time by paying the exercise price of $ 0.01 per share, subject to the terms discussed in Note 8.
In connection with the 2022 RDO discussed in Note 8, the Company issued 1,973,684 Class A PFWs and 10,947,371 Class B PFWs to purchase an aggregate of 12,921,055 shares of common stock at an issuance price of $ 3.799 per warrant. As of June 30, 2023 all of the Class A PFWs and Class B PFWs may be exercised at any time by paying the exercise price of $ 0.001 per share, subject to the terms discussed in Note 8.
Other Warrants
In connection with an equity financing in October 2020, the Company issued warrants entitling the holders to purchase approximately 0.8 million shares of common stock. The warrants are exercisable at $ 19.50 per share for a period of seven years , may be exercised on a cash or cashless basis at the election of the holders, and holders are entitled to share in any dividends or distributions payable to holders of common stock on an as-converted basis (the “Participating Warrants”). Additionally, the Company has issued warrants to purchase shares of common stock in conjunction with other debt and equity financings and for services. As of June 30, 2023 and 2022, all of the warrants were vested. For the fiscal years ended June 30, 2023 and 2022, no warrants were granted or exercised. Excluding the pre-funded warrants discussed above, the following table summarizes activity for all other warrants for the fiscal years ended June 30, 2023 and 2022 (shares in thousands):
2023
2022
Shares
Price (1)
Term (2)
Shares
Price (1)
Term (2)
Outstanding, beginning of fiscal year
1,150
$
22.83
4.2
1,252
$
28.91
4.8
Expirations
( 262 )
25.32
( 102 )
97.79
Outstanding, end of fiscal year
888
22.10
3.5
1,150
22.83
4.2
(1) Represents the weighted average exercise price.
(2) Represents the weighted average remaining contractual term for the number of years until the warrants expire.
NOTE 10 — INCOME TAXES
Net Operating Loss Carryforwards
The Company files income tax returns in the U.S. federal jurisdiction and in several states including California, Colorado, and Oregon. The Company’s federal and state tax returns for the 2020 fiscal year and forward are subject to examination by taxing authorities. Federal and state laws impose substantial restrictions on the utilization of federal net operation loss (“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 is limited in the event that a cumulative change in ownership of more than 50% occurs within a three-year period. During the fiscal year ended June 30, 2022, the Company completed an IRC Section 382 analysis and concluded that the Company’s NOL carryforwards are subject to limitations as a result of past ownership changes.
52
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
As of June 30, 2023, the Company has U.S. federal net operating loss (“NOL”) carryforwards of approximately $ 153.2 million, of which approximately $ 33.4 million of NOL carryforwards will never be available for use due to the limitations under IRC section 382 discussed above. The remainder of the Company’s NOL carryforwards of $ 119.8 million consists of (i) $ 17.1 million that never expires and is currently available to offset taxable income, (ii) $ 7.9 million that is currently available to offset taxable income but if not utilized expires in 2031 through 2035, (iii) $ 13.4 million that become available through fiscal year 2038 and that expires by June 30, 2038 if not utilized, and (iv) $ 81.4 million that never expires. With respect to the $ 81.4 million of NOL carryforwards that never expire, this amount will become available in varying annual amounts for an aggregate approximately $ 15.6 million through fiscal year 2038 and $ 1.2 million annually thereafter. If the Company experiences future ownership changes that meet the aforementioned criteria under Section 382, further limitations will be imposed on the use of all NOL carryforwards existing through the date of such change. The Company also has Colorado and California NOL carryforwards that begin to expire in 2031 and are expected to be subject to similar limitations as those imposed under IRC Section 382.
Income Tax Expense
For the fiscal years ended June 30, 2023 and 2022, 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 consolidated financial statements is as follows (in thousands):
2023
2022
Income tax benefit at statutory US federal rate
$
10,875
$
8,622
Income tax benefit attributable to US states
3,468
3,151
Impact of reduction in Colorado tax rate
( 78 )
—
Non-taxable derivative gains
—
1,379
Non-deductible expenses
( 442 )
( 527 )
Stock option expirations
( 921 )
( 332 )
Other
( 399 )
25
Change in valuation allowance
( 12,503 )
( 12,318 )
Total income tax expense
$
—
$
—
For the fiscal years ended June 30, 2023 and 2022, the Company did not recognize any current income tax expense or benefit due to a full valuation allowance on its net deferred income tax assets.
53
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Deferred Income Tax Assets and Liabilities
As of June 30, 2023 and 2022, the income tax effects of temporary differences that give rise to significant deferred income tax assets and liabilities are as follows (in thousands):
2023
2022
Deferred income tax assets:
Net operating loss carryforwards
$
40,537
$
38,361
Research and experimental costs
9,454
—
Intangible assets
5,595
5,215
Share-based compensation
2,884
2,725
Operating lease liabilities
694
—
Accrued expenses and other
603
293
Total deferred income tax assets
59,767
46,594
Valuation allowance for deferred income tax assets
( 59,192 )
( 46,594 )
Deferred income tax assets, net of valuation allowance
575
—
Deferred income tax liability right-of-use assets
( 575 )
—
Net deferred income tax assets
$
—
$
—
For the fiscal year ended June 30, 2023, the valuation allowance increased by $ 12.5 million, primarily as a result of the increase in net operating losses and capitalization of research and experimental costs that was required beginning in the fiscal year ended June 30, 2023. 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.
Unrecognized Tax Benefits
The Company did not have any unrecognized tax benefits as of June 30, 2023 and 2022. 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.
NOTE 11 — COMMITMENTS AND CONTINGENCIES
Licensing Commitments
Please refer to Note 5 for further discussion of commitments to make milestone payments and to pay royalties under license agreements with XOMA and ActiveSite.
Employment Agreements
As of June 30, 2023, the Company was subject to employment agreements with two officers of the Company and one employee of the Company that provide for aggregate annual base salaries of $ 1.4 million.
The agreements with the Chief Executive Officer and Chief Medical Officer provides that if either of individuals is terminated outside of a change in control event and without cause, (i) all of their stock options that are subject to ongoing vesting conditions over subsequent periods ranging from 12 to 18 months will immediately vest, and (ii) such stock options will remain exercisable for periods ranging from 6 to 12 months following the occurrence of the termination event. In addition, if either or both of the executive officers are terminated solely due to a change of control event, all of their
54
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
respective unvested stock options will immediately vest and all outstanding stock options will remain exercisable for periods ranging from 6 to 12 months following the occurrence of the termination event.
The amendment to the Chief Medical Officer’s employment agreement provides that upon the occurrence of a termination event other than a change of control, the Company is required to (i) make severance payments equal to 12 months of salary, a pro-rata bonus, and health insurance coverage for 12 months following the termination date, and (ii) all unvested stock options subject to vest over the subsequent 12 month period after the termination event will become immediately exercisable and all outstanding stock options will remain exercisable for 6 months following the termination event. In addition, upon the occurrence of a termination solely due to a change of control event, the Company is required to (i) make severance payments equal to 18 months of salary, a pro-rata bonus, and health insurance coverage for 18 months following the termination event.
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 the 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 $ 0.3 million and $ 0.2 million for the fiscal years ended June 30, 2023 and 2022, respectively.
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, 2023, 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.
NOTE 12 — RELATED PARTY TRANSACTIONS
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.
Investors in Registered Direct Offerings
In connection with the 2021 Underwritten Offering discussed in Note 8, a group of affiliated investors purchased approximately (i) 1,930,000 shares of common stock at $ 6.50 per share for a total of $ 12.5 million, and (ii) 2021 PFWs exercisable for the purchase of 123,000 shares at $ 6.49 per 2021 PFW for a total issuance price of $ 0.8 million.
In connection with the 2022 RDO discussed in Note 8, certain officers and directors of the Company purchased 111,840 shares of common stock at $ 3.80 per share for a total of $ 0.4 million. In addition, the group of affiliated investors discussed above purchased (i) 3,421,052 shares of common stock at $ 3.80 per share for a total of $ 12.2 million, and (ii) 3,421,053 Class B PFWs at $ 3.799 each for a total of $ 12.2 million.
55
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Investors in 2022 Private Placement
Handok and certain of its affiliates were the sole investors in the 2022 Private Placement and the Registered Direct Offering discussed in Note 7.
NOTE 13 - SUPPLEMENTAL FINANCIAL INFORMATION
Cash and cash equivalents
Cash and cash equivalents consist of the following as of June 30, 2023 and 2022 (in thousands):
2023
2022
Demand deposits at a single financial institution
$
6,091
$
150,410
Money market funds
5,464
—
Commercial paper
4,481
—
Total
$
16,036
$
150,410
The money market funds and commercial paper included in the table above were purchased with an original maturity of three months or less. These investments and the demand deposits are freely available for the Company’s immediate and general business use.
Property and Equipment
Property and equipment consisted of the following as of June 30, 2023 and 2022 (in thousands):
2023
2022
Office furniture and equipment
$
210
$
56
Less accumulated depreciation
( 71 )
( 40 )
Total
$
139
$
16
Depreciation expense related to property and equipment amounted to approximately $ 30,000 and $ 13,000 for the fiscal years ended June 30, 2023 and 2022, respectively.
NOTE 14 — NET LOSS PER SHARE
Basic net loss per share is computed by dividing net loss by the weighted average number of outstanding shares of common stock and pre-funded warrants that are accounted for as equity instruments. For the calculation of diluted net loss per share for the fiscal year ended June 30, 2022, since the impact of accounting for the pre-funded warrants as derivative liabilities was dilutive, the numerator was adjusted to eliminate gains on changes in fair value of such pre-funded warrants, and the denominator was adjusted to include the related pre-funded warrant shares.
Calculation of the weighted average number of shares outstanding for purposes of diluted net loss per share is also required to include the dilutive effect, if any, of stock options, warrants, and other common stock equivalents computed using the treasury stock method. For the fiscal years ended June 30, 2023 and 2022, all of such common stock equivalents were
56
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
antidilutive and exclude from the calculations. In addition, the impact of applying the two-class method related to the Participating Warrants, was antidilutive for the calculation of both basic and diluted net loss per share.
Presented below are the calculations of the numerators and the denominators for basic and diluted net loss per share for the fiscal years ended June 30, 2023 and 2022 (in thousands except per share amounts):
2023
2022
Calculation of Numerators:
Net loss for calculation of basic net loss per share
$
( 51,787 )
$
( 41,060 )
Dilutive derivative gains, net of losses, related to Class B PFWs:
Gain from change in fair value of derivative liability
—
( 6,565 )
(1)
Underwriting discount on issuance of derivative
—
2,495
(1)
Net loss for the calculation of diluted net loss per share
$
( 51,787 )
$
( 45,130 )
Calculation of Denominators:
Weighted Average number of common shares outstanding
36,605
16,254
Weighted average shares related to pre-funded warrants:
2021 PFWs
1,661
(6)
1,179
(2)
Class A PFWs
1,974
(6)
314
(3)
Class B PFWs
10,947
(6)
450
(4)
Weighted average shares for basic net loss per share
51,187
18,197
Weighted average adjustment for Class B PFWs
—
1,290
(5)
Weighted average shares for diluted net loss per share
51,187
19,487
Net loss per share of common stock:
Basic
$
( 1.01 )
$
( 2.26 )
Diluted
$
( 1.01 )
$
( 2.32 )
__________________
(1) For the calculation of diluted net loss per share, the net impact of the discount expense and the derivative gain related to the Class B PFWs is dilutive and has been eliminated from the denominator for the period from the issuance date on May 4, 2022 through June 16, 2022, when the fair value of the Class B PFWs was reclassified to stockholders’ equity.
(2) Represents the weighted average number of shares related to the 2021 PFWs discussed in Note 8 for the period from the issuance date on October 15, 2021 through June 30, 2022.
(3) Represents the weighted average number of shares related to the Class A PFWs discussed in Note 8 for the period from the issuance date on May 4, 2022 through June 30, 2022.
(4) Represents the weighted average number of shares related to the Class B PFWs discussed in Note 8 for the period when they became equity-classified on June 16, 2022 through June 30, 2022.
(5) Represents the weighted average number of shares related to the Class B PFWs discussed in Note 7 during the period when they were liability-classified from the issuance date on May 4, 2022 through June 15, 2022.
(6) Represents the number of PFWs that were outstanding for the entirety of the fiscal year ended June 30, 2023.
57
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
As of June 30, 2023 and 2022, the following potential common stock equivalents were excluded from the calculation of diluted net loss per share since the impact of inclusion was anti-dilutive (in thousands):
2023
2022
Stock options
8,745
8,506
Other warrants
888
1,150
Total
9,633
9,656
NOTE 15 — FINANCIAL INSTRUMENTS AND SIGNIFICANT 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 corroboration, 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 the measurement date.
The following table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the fair value hierarchy classification of such fair values as of June 30, 2023.
Fair Value Measurement of Assets as of June 30, 2023
Total
Level 1
Level 2
Level 3
Cash and cash equivalents:
Money market funds
$
5,464
$
5,464
$
—
$
—
Corporate commercial paper
4,481
4,481
Marketable debt securities:
Corporate commercial paper
41,597
—
41,597
—
U.S. Government agencies
26,394
—
26,394
—
U.S. Government treasuries
10,404
10,404
—
—
Corporate notes and bonds
19,240
—
19,240
—
Asset-backed securities
4,694
—
4,694
—
Total
$
112,274
$
20,349
$
91,925
$
—
58
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
Marketable debt securities classified as Level 2 within the valuation hierarchy generally consist of U.S. government agency securities, corporate bonds, and commercial paper. The Company determines the fair value of marketable debt securities based upon valuations obtained from third-party pricing sources. Except for the amounts shown in the table above, the Company did not have any other assets measured at fair value on a recurring basis as of June 30, 2023. As of June 30, 2022, the Company did not have any assets required to be measured at fair value on a recurring basis.
The derivative liabilities for the authorized share deficiencies discussed in Note 7 were classified under Level 3. These liabilities were required to be measured at fair value on a recurring basis from May 4, 2022 until June 16, 2022. Key valuation assumptions are summarized in Note 7.
The embedded derivative liabilities discussed in Note 6 were classified under Level 3 and were required to be measured at fair value on a recurring basis beginning on April 14, 2021. Fair value is determined using a discounted rate equal to the effective interest rate under the Loan Agreement and based on management’s assessment of the probability that an Exit Event will occur prior to April 13, 2031.
The following table sets forth a summary of changes in the fair value of embedded derivative liabilities for which fair value was determined by Level 3 inputs for the fiscal years ended June 30, 2023 and 2022 (in thousands):
2023
2022
Fair value, beginning of period
$
407
$
387
Loss from change in fair value, net
5
20
Fair value, end of period
$
412
$
407
Except for embedded derivative liabilities, the Company did not have any other liabilities measured at fair value on a recurring basis as of June 30, 2023 and 2022.
Due to the relatively short maturity of the respective instruments, the fair value of cash and cash equivalents, accounts payable, and accrued liabilities approximated their carrying values as of June 30, 2023 and 2022.
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, 2023 and 2022, the Company did not have any 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 and investments in marketable debt securities. The Company maintains its cash in demand accounts at a high-quality financial institution. As of and for the fiscal years ended June 30, 2023 and 2022, cash deposits have exceeded the amount of insurance provided on such deposits by the Federal Deposit Insurance Corporation (“FDIC”).
As of June 30, 2023, the Company has an aggregate of $ 54.0 million invested in marketable debt securities of issuers in the banking and financial services industries, and an aggregate of $ 26.5 million invested in marketable debt securities of a single agency of the U.S. government. While the Company’s investment policy requires investments in highly rated securities, a wide variety of broad economic factors and issuer-specific factors could result in credit agency downgrades below the Company’s minimum credit rating requirements that could result in losses regardless of whether the Company elects to sell the securities or hold them until maturity.
On March 10, 2023, Silicon Valley Bank (“SVB”) was shut down, followed on March 11, 2023 by Signature Bank and on May 1, 2023 by First Republic Bank whereby the FDIC was appointed as receiver for each of those banks. Starting in January 2023, SVB Asset Management (“SAM”), a nonbank affiliate of SVB and a member of SVB Financial Group,
59
Table of Contents
REZOLUTE, INC.
Notes to Consolidated Financial Statements
provided investment services relating to the Company’s investment in marketable debt securities held in a segregated custodial account maintained by a third-party custodian, U.S. Bank. At the time of the closing of SVB, the Company had approximately $ 20.5 million in cash and certain cash equivalents in an Overnight Money Market Mutual Fund (“MMF”), for which SAM served as the investment advisor until April 13, 2023, when the MMF was liquidated and transferred to a similar investment under the control of a new investment advisor. The Company’s investment portfolio did not and currently does not contain any securities of SVB, and the Company did not have any deposit accounts with SVB. The Company does not believe it was or will be impacted by the closure of SVB and will continue to monitor the banking industry situation as it evolves.
60
Table of Contents
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None
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.