Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Dec. 31, 2022 | Feb. 06, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Dec. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-39683 | |
Entity Registrant Name | REZOLUTE, INC. | |
Entity Incorporation, State or Country Code | NV | |
Entity Tax Identification Number | 27-3440894 | |
Entity Address, Address Line One | 275 Shoreline Drive, Suite 500 | |
Entity Address, City or Town | Redwood City | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94065 | |
City Area Code | 650 | |
Local Phone Number | 206-4507 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | RZLT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 36,827,567 | |
Entity Central Index Key | 0001509261 | |
Current Fiscal Year End Date | --06-30 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Jun. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 146,746 | $ 150,410 |
Prepaid expenses and other | 860 | 1,694 |
Total current assets | 147,606 | 152,104 |
Right-of-use assets | 2,294 | 152 |
Property and equipment, net | 160 | 16 |
Deposits and other | 148 | 148 |
Total assets | 150,208 | 152,420 |
Current liabilities: | ||
Accounts payable | 2,841 | 1,132 |
Accrued liabilities: | ||
Compensation and benefits | 2,234 | |
Accrued clinical and other | 1,071 | 979 |
Insurance premiums | 243 | |
Current portion of operating lease liabilities | 167 | 108 |
Total current liabilities | 6,313 | 2,462 |
Long term liabilities: | ||
Operating lease liabilities, net of current portion | 2,196 | 80 |
Embedded derivative liabilities | 434 | 407 |
Total liabilities | 8,943 | 2,949 |
Commitments and contingencies (Notes 3, 4, 8 and 9) | ||
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 December 31, 2022 and June 30, 2022, respectively | 37 | 34 |
Additional paid-in capital | 373,813 | 358,635 |
Accumulated deficit | (232,585) | (209,198) |
Total shareholders' equity | 141,265 | 149,471 |
Total liabilities and shareholders' equity | $ 150,208 | $ 152,420 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Dec. 31, 2022 | Jun. 30, 2022 |
Unaudited Condensed Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 400 | 400 |
Preferred stock, shares, issued | 0 | 0 |
Preferred stock, shares, outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000 | 100,000 |
Common stock, shares issued | 36,827 | 33,582 |
Common stock, shares outstanding | 36,827 | 33,582 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||||
Research and development | $ 10,945 | $ 9,452 | $ 18,649 | $ 15,226 |
General and administrative | 3,447 | 2,697 | 5,961 | 4,563 |
Total operating expenses | 14,392 | 12,149 | 24,610 | 19,789 |
Operating loss | (14,392) | (12,149) | (24,610) | (19,789) |
Non-operating income (expense): | ||||
Interest and other income | 849 | 13 | 1,249 | 13 |
Gain (loss) from change in fair value of derivative liabilities | (13) | (12) | (26) | 4 |
Employee retention credit | 231 | |||
Interest expense | (445) | (888) | ||
Total non-operating income (expense), net | 836 | (444) | 1,223 | (640) |
Net loss | $ (13,556) | $ (12,593) | $ (23,387) | $ (20,429) |
Net loss per common share - basic (in dollars per share) | $ (0.26) | $ (0.80) | $ (0.46) | $ (1.69) |
Net loss per common share - diluted (in dollars per share) | $ (0.26) | $ (0.80) | $ (0.46) | $ (1.69) |
Weighted average number of common shares outstanding - basic (in shares) | 51,410 | 15,680 | 50,969 | 12,097 |
Weighted average number of common shares outstanding - diluted (in shares) | 51,410 | 15,680 | 50,969 | 12,097 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Common Stock 2022 Private Placement | Common Stock Registered Direct Offering 2021 [Member] | Common Stock Equity Distribution Agreement | Common Stock LPC Purchase Agreement | Common Stock 2021 Underwritten Public Offering | Common Stock | Additional Paid-in Capital 2022 Private Placement | Additional Paid-in Capital Registered Direct Offering 2021 [Member] | Additional Paid-in Capital Equity Distribution Agreement | Additional Paid-in Capital LPC Purchase Agreement | Additional Paid-in Capital 2021 Underwritten Public Offering 2021 Pre-Funded Warrants | Additional Paid-in Capital 2021 Underwritten Public Offering | Additional Paid-in Capital 2021 Pre-Funded Warrants | Additional Paid-in Capital | Accumulated Deficit | 2022 Private Placement | Registered Direct Offering 2021 [Member] | Equity Distribution Agreement | LPC Purchase Agreement | 2021 Underwritten Public Offering 2021 Pre-Funded Warrants | 2021 Underwritten Public Offering | 2021 Pre-Funded Warrants | Total |
Balance at Jun. 30, 2021 | $ 8 | $ 194,229 | $ (168,138) | $ 26,099 | |||||||||||||||||||
Balance (in shares) at Jun. 30, 2021 | 8,352,000 | ||||||||||||||||||||||
Gross proceeds from issuance of common stock for cash | $ 1 | $ 1 | $ 6 | $ 4,999 | $ 1,518 | $ 1,172 | $ 10,783 | $ 39,950 | $ 5,000 | $ 1,519 | $ 1,172 | $ 10,783 | $ 39,956 | ||||||||||
Gross proceeds from issuance of common stock for cash (in shares) | 769,000 | 138,000 | 116,000 | 6,147,000 | 138,388 | ||||||||||||||||||
Underwriting commissions, discounts and other equity offering costs | (4,136) | (4,136) | |||||||||||||||||||||
Share-based compensation | 1,851 | 1,851 | |||||||||||||||||||||
Issuance of commitment shares | 450 | 450 | |||||||||||||||||||||
Issuance of commitment shares (in shares) | 34,000 | ||||||||||||||||||||||
Net loss | (20,429) | (20,429) | |||||||||||||||||||||
Balance at Dec. 31, 2021 | $ 16 | 250,816 | (188,567) | 62,265 | |||||||||||||||||||
Balance (in shares) at Dec. 31, 2021 | 15,556,000 | ||||||||||||||||||||||
Balance at Jun. 30, 2021 | $ 8 | 194,229 | (168,138) | 26,099 | |||||||||||||||||||
Balance (in shares) at Jun. 30, 2021 | 8,352,000 | ||||||||||||||||||||||
Net loss | (41,100) | ||||||||||||||||||||||
Balance at Jun. 30, 2022 | $ 34 | 358,635 | (209,198) | 149,471 | |||||||||||||||||||
Balance (in shares) at Jun. 30, 2022 | 33,582,000 | ||||||||||||||||||||||
Balance at Sep. 30, 2021 | $ 9 | 197,524 | (175,974) | 21,559 | |||||||||||||||||||
Balance (in shares) at Sep. 30, 2021 | 8,640,000 | ||||||||||||||||||||||
Gross proceeds from issuance of common stock for cash | $ 1 | $ 6 | $ 4,999 | $ 39,950 | $ 10,783 | $ 5,000 | $ 39,956 | $ 10,783 | |||||||||||||||
Gross proceeds from issuance of common stock for cash (in shares) | 769,000 | 6,147,000 | |||||||||||||||||||||
Underwriting commissions, discounts and other equity offering costs | (3,449) | (3,449) | |||||||||||||||||||||
Share-based compensation | 1,009 | 1,009 | |||||||||||||||||||||
Net loss | (12,593) | (12,593) | |||||||||||||||||||||
Balance at Dec. 31, 2021 | $ 16 | 250,816 | (188,567) | 62,265 | |||||||||||||||||||
Balance (in shares) at Dec. 31, 2021 | 15,556,000 | ||||||||||||||||||||||
Balance at Jun. 30, 2022 | $ 34 | 358,635 | (209,198) | 149,471 | |||||||||||||||||||
Balance (in shares) at Jun. 30, 2022 | 33,582,000 | ||||||||||||||||||||||
Gross proceeds from issuance of common stock for cash | $ 3 | $ 12,327 | $ 12,330 | ||||||||||||||||||||
Gross proceeds from issuance of common stock for cash (in shares) | 3,245,000 | ||||||||||||||||||||||
Underwriting commissions, discounts and other equity offering costs | (759) | (759) | |||||||||||||||||||||
Share-based compensation | 3,610 | 3,610 | |||||||||||||||||||||
Net loss | (23,387) | (23,387) | |||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 37 | 373,813 | (232,585) | 141,265 | |||||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 36,827,000 | ||||||||||||||||||||||
Balance at Sep. 30, 2022 | $ 37 | 372,082 | (219,029) | 153,090 | |||||||||||||||||||
Balance (in shares) at Sep. 30, 2022 | 36,827,000 | ||||||||||||||||||||||
Share-based compensation | 1,731 | 1,731 | |||||||||||||||||||||
Net loss | (13,556) | (13,556) | |||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 37 | $ 373,813 | $ (232,585) | $ 141,265 | |||||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 36,827,000 |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||
Net loss | $ (23,387) | $ (20,429) | |||
Share-based compensation expense | 3,610 | 1,851 | |||
Non-cash lease expense | 112 | 159 | |||
Loss (gain) from change in fair value of derivative liabilities | $ 13 | $ 12 | 26 | (4) | |
Depreciation and amortization expense | 10 | 7 | |||
Accretion of debt discount and issuance costs | 211 | ||||
Changes in operating assets and liabilities: | |||||
Decrease in prepaid expenses and other assets | 783 | 238 | |||
Increase in accounts payable | 1,708 | 3,320 | |||
Increase in other accrued liabilities | 2,056 | 1,109 | |||
Net Cash Used in Operating Activities | (15,082) | (13,538) | $ (39,600) | ||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Purchase of property and equipment | (153) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Payment of commissions and other offering costs | (759) | (3,430) | |||
Payment of debt discount and issuance costs | (104) | ||||
Net Cash Provided by Financing Activities | 11,571 | 54,894 | |||
Net increase (decrease) in cash, cash equivalents and restricted cash | (3,664) | 41,356 | |||
Cash, cash equivalents and restricted cash at beginning of period | 150,410 | 41,047 | 41,047 | ||
Cash, cash equivalents and restricted cash at end of period | $ 146,746 | $ 82,403 | 146,746 | 82,403 | $ 150,410 |
SUPPLEMENTARY CASH FLOW INFORMATION: | |||||
Cash paid for interest | 680 | ||||
Cash paid for amounts included in the measurement of operating lease liabilities | 58 | 184 | |||
Operating lease liabilities incurred in exchange for right-of-use-assets | 2,204 | ||||
NON-CASH INVESTING AND FINANCING ACTIVITIES: | |||||
Issuance of commitment shares for deferred offering costs subsequently charged to additional paid-in capital | 450 | ||||
2022 Private Placement | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceeds from issuances of common stock | $ 12,330 | ||||
2021 Underwritten Public Offering | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceeds from issuances of common stock | 50,738 | ||||
2021 Registered Direct Offering | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceeds from issuances of common stock | 5,000 | ||||
EDA with Oppco | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceeds from issuances of common stock | 1,519 | ||||
LPC Purchase Agreement | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceeds from issuances of common stock | $ 1,171 |
NATURE OF OPERATIONS AND SUMMAR
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Dec. 31, 2022 | |
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 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. The Company’s primary clinical assets consist of (i) RZ358, which is a potential treatment for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas, and (ii) RZ402, which is an oral plasma kallikrein inhibitor (“PKI”) being developed as a potential therapy for the chronic treatment of diabetic macular edema. Basis of Presentation The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), the rules and regulations of the SEC for interim financial information, and the instructions to Form 10-Q and Article 8 of Regulation S-X. The condensed consolidated balance sheet as of June 30, 2022, has been derived from the Company’s audited consolidated financial statements. The unaudited interim financial statements should be read in conjunction with the Company’s 2022 Form 10-K, which contains the Company’s audited financial statements and notes thereto, together with the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal year ended June 30, 2022. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all information and footnote disclosures necessary for a comprehensive presentation of financial position, results of operations, and cash flows. It is management’s opinion, however, that all material adjustments (consisting of normal recurring adjustments) that are necessary for a fair financial statement presentation have been made. The interim results for the three and six months ended December 31, 2022 are not necessarily indicative of the financial condition and results of operations that may be expected for any future interim period or for the fiscal year ending June 30, 2023. 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. 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 unaudited condensed 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, the fair value of derivative liabilities, fair value of share-based payments, 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, and the future impact of COVID-19. Significant Accounting Policies The Company’s significant accounting policies are described in Note 1 to the financial statements in Item 8 of the 2022 Form 10-K. Recent Accounting Pronouncements Recently Adopted Standard. In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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). Standard Required to be Adopted in Future Periods. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Financial Instruments- Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) 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. |
LIQUIDITY
LIQUIDITY | 6 Months Ended |
Dec. 31, 2022 | |
LIQUIDITY | |
LIQUIDITY | NOTE 2 — LIQUIDITY The Company is in the clinical stage and has not yet generated any revenues. For the six months ended December 31, 2022, the Company incurred a net loss of $23.4 million and net cash used in operating activities amounted to $15.1 million. For the fiscal year ended June 30, 2022, the Company incurred a net loss of $41.1 million and net cash used in operating activities amounted to $39.6 million. As of December 31, 2022, the Company had an accumulated deficit of $232.6 million, cash and cash equivalents of $146.7 million, and total current liabilities of $6.3 million. As discussed in Note 4, the Company is subject to license agreements that provide for future contractual payments upon achievement of various milestone events. Pursuant to the ActiveSite License Agreement (as defined below), a $3.0 million milestone payment will be due upon dosing of the first patient in a Phase 2 clinical trial for RZ402. Additionally, 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 RZ402 Phase 2 clinical trial was triggered in February 2023. First patient dosing milestone RZ358 Phase 3 clinical trial is expected to occur within the next 12 months. Management believes the Company’s cash and cash equivalents balance of $146.7 million as of December 31, 2022, will be adequate to meet the Company’s contractual obligations and carry out ongoing clinical trials and other planned activities at least through February 2024. |
OPERATING LEASES
OPERATING LEASES | 6 Months Ended |
Dec. 31, 2022 | |
OPERATING LEASES | |
OPERATING LEASES | NOTE 3 — OPERATING 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. The landlord was required to make improvements to the facility before the Company could occupy the space. These improvements were completed in October 2022, triggering the commencement of the lease. The lease provides for a six-month rent abatement period beginning upon commencement of the lease term. In addition, the lease provides an allowance of approximately $0.1 million that may be 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. 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. The carrying value of all right-of-use assets and operating lease liabilities are as follows (in thousands): December 31, June 30, 2022 2022 Right-of-use assets $ 2,294 $ 152 Operating lease liabilities: Current $ 167 $ 108 Long-term 2,196 80 Total $ 2,363 $ 188 For the three and six months ended December 31, 2022 and 2021, operating lease expense is included under the following captions in the accompanying condensed consolidated statements of operations (in thousands): Three Months Ended Six Months Ended December 31, December 31, 2022 2021 2022 2021 Research and development $ 115 $ 71 $ 192 $ 150 General and administrative 48 20 71 43 Total $ 163 $ 91 $ 263 $ 193 As of December 31, 2022, the weighted average remaining lease term under operating leases was 4.6 years, and the weighted average discount rate for operating lease liabilities was 6.8%. Future payments under all operating lease agreements as of December 31, 2022 are as follows (in thousands): Fiscal year ending June 30, Remainder of fiscal year 2023 $ 109 2024 689 2025 627 2026 646 2027 666 Thereafter 224 Total lease payments 2,961 Less imputed interest (598) Present value of operating lease liabilities $ 2,363 |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 6 Months Ended |
Dec. 31, 2022 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | NOTE 4 — LICENSE AGREEMENTS XOMA License Agreement In December 2017, the Company entered into a license agreement (the “XOMA 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. In January 2019, the XOMA License Agreement was amended with an updated payment schedule, as well as revising the amount the Company was 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 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. 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 On August 4, 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 License Agreement requires various milestone payments up to $46.5 million, if all milestones 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 next milestone payment of $3.0 million will be due upon dosing of the first patient in a Phase 2 clinical trial for RZ402. 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. |
EMBEDDED DERIVATIVE LIABILITY
EMBEDDED DERIVATIVE LIABILITY | 6 Months Ended |
Dec. 31, 2022 | |
EMBEDDED DERIVATIVE LIABILITY | |
EMBEDDED DERIVATIVE LIABILITY | NOTE 5 — EMBEDDED DERIVATIVE LIABILTY On April 14, 2021, the Company entered into a $30.0 million Loan and Security Agreement (the “Loan Agreement”) with SLR Investment Corp. and certain other lenders (the “Lenders”). The Lenders agreed to loan up to $30.0 million in three tranches consisting of (i) a $15.0 million term A loan that was funded on April 14, 2021, (ii) term B and term C loans for an aggregate of $15.0 million, which were subject to the Company’s ability to obtain prescribed amounts of financing and the achievement of certain clinical milestones. The Company did not achieve the initial clinical milestones by January 2022 and, accordingly, the term B and term C loans were no longer a source of liquidity. The term A loan had a maturity date of April 1, 2026 (the “Maturity Date”), but was repaid in full on June 30, 2022. 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 of each term loan in the event certain transactions (defined as “Exit Events”) occur prior to April 13, 2031. 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. As of April 14, 2021, the Company allocated a portion of the proceeds from the term A loan to recognize a liability for the fair value of embedded derivatives. Fair value was determined primarily based on the Company’s strategic corporate development plans and management has performed a detailed evaluation of the different types of Exit Events that could occur and using a discounted rate equivalent to the effective rate for the term A loan. 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. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 6 Months Ended |
Dec. 31, 2022 | |
SHAREHOLDERS' EQUITY | |
SHAREHOLDERS' EQUITY | NOTE 6 — SHAREHOLDERS’ EQUITY Changes in Shareholders’ Equity for the Three Months Ended December 31, 2022 and 2021 The following table presents changes in shareholders’ equity for the three months ended December 31, 2022 and 2021: Additional Total Common Stock Paid-in Accumulated Shareholders' Shares Amount Capital Deficit Equity Three Months Ended December 31, 2022: Balances, September 30, 2022 36,827 $ 37 $ 372,082 $ (219,029) $ 153,090 Share-based compensation — — 1,731 — 1,731 Net loss — — — (13,556) (13,556) Balances, December 31, 2022 36,827 $ 37 $ 373,813 $ (232,585) $ 141,265 Three Months Ended December 31, 2021: Balances, September 30, 2021 8,640 $ 9 $ 197,524 $ (175,974) $ 21,559 Gross proceeds from issuance of equity securities for cash in Underwritten Offering: Common stock 6,147 6 39,950 — 39,956 Pre-Funded Warrants — — 10,783 — 10,783 Gross proceeds from issuance of common stock for cash in Registered Direct Offering 769 1 4,999 — 5,000 Underwriting discounts and other equity offering costs — — (3,449) — (3,449) Share-based compensation — — 1,009 — 1,009 Net loss — — — (12,593) (12,593) Balances, December 31, 2021 15,556 $ 16 $ 250,816 $ (188,567) $ 62,265 July 2022 Financing In May 2022, the Company entered into securities purchase agreements (“SPAs”) with Handok, Inc. (“Handok”) and certain of its affiliates. Handok is an affiliate of a member of the Company’s Board of Directors. In July 2022, the Company entered into amended SPAs for a private placement of common stock (the “2022 Private Placement”). The 2022 Private Placement resulted in gross proceeds of $12.3 million in exchange for the issuance of approximately 3.2 million shares of common stock. The Company incurred approximately $0.8 million for underwriting commissions and other offering costs, resulting in net proceeds of $11.5 million. Underwritten Public Offering On October 12, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Oppenheimer & Co., Inc., as representative of the underwriters listed therein (the “Underwriters”) for the planned issuance and sale of equity securities in an underwritten public offering (the “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 “Pre-Funded Warrants”) for gross proceeds of $10.8 million. The aggregate gross proceeds from the Underwritten Offering amounted to $50.0 million, excluding the exercise of the Underwriters’ Option discussed below, and before deductions for underwriting discounts and 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. In connection with the Underwritten Offering, the Company granted the Underwriters a 30-day Pre-Funded Warrants The Pre-Funded Warrants issued in the Underwritten Offering 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 Pre-Funded Warrant 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 Pre-Funded Warrants will be entitled to receive, upon exercise of the Pre-Funded Warrants, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such transaction. The Pre-Funded Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of the Company’s common stock are entitled. The gross proceeds of $10.8 million received from issuance of the Pre-Funded Warrants 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 Pre-Funded Warrant 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%. As of December 31, 2022, no shares underlying the Pre-Funded Warrants have been exercised. Registered Direct Offering Concurrently with the Underwritten Offering, a major shareholder (the “Purchaser”) that is affiliated with a member of our Board of Directors entered into a subscription agreement for a registered direct offering, pursuant to which the Company agreed to sell to the Purchaser an aggregate of 769,231 shares of the Company’s common stock at a purchase price of $6.50 per share. The closing for the registered direct offering occurred on October 27, 2021, whereby the Company received gross proceeds of $5.0 million. Equity Distribution Agreement In December 2020, the Company and Oppenheimer & Co. Inc. (the “Agent”) entered into an Equity Distribution Agreement (the “EDA”) that provides for an “at the market offering” for the sale of up to $50.0 million in shares of the Company’s common stock (the “Placement Shares”) through the Agent. The Agent was acting as sales agent and was required to use commercially reasonable efforts to sell all of the Placement Shares requested to be sold by the Company, consistent with the Agent’s normal trading and sales practices, on mutually agreed terms between the Agent and the Company. The EDA was scheduled to terminate when all of the Placement Shares had been sold, or earlier upon the election of either the Company or the Agent. In May 2022, the Company provided the Agent with notice of termination of the EDA and no further shares will be issued under this agreement. Under the terms of the EDA, the Company agreed to pay the Agent a commission equal to 3.0% of the gross sales price of the Placement Shares plus certain expenses incurred by the Agent in connection with the offering. For the six months ended December 31, 2021, the Company sold 138,388 shares of its common stock pursuant to the EDA for net proceeds of approximately $1.5 million. LPC Purchase Agreement In August 2021, the Company entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “RRA”) with Lincoln Park Capital Fund, LLC (“LPC”), which provides that the Company may sell to LPC up to an aggregate of $20.0 million shares (the “Purchase Shares”) of its common stock. The Company concurrently filed a prospectus supplement with the SEC to register the shares issuable under the Purchase Agreement. The aggregate number of shares that the Company could sell to LPC under the Purchase Agreement was 1,669,620 shares of common stock, subject to certain exceptions set forth in the Purchase Agreement. LPC’s initial purchase consisted of 95,708 Purchase Shares at a purchase price of approximately $10.45 per share for a total purchase price of $1.0 million. Concurrently, the Company issued 33,799 shares of common stock to LPC as an initial fee for its commitment to purchase shares of common stock under the Purchase Agreement. Subject to the terms of the Purchase Agreement, the Company had the right, in its sole discretion, to present LPC with a purchase notice (a “Regular Purchase Notice”), directing LPC to purchase up to 25,000 Purchase Shares (a “Regular Purchase”). LPC’s committed obligation under any single Regular Purchase generally could not exceed $2.0 million. The Purchase Agreement provided for a purchase price per share for each Regular Purchase (the “Purchase Price”) equal to the lesser of (i) the lowest sale price of the common stock on the Nasdaq Capital Market (“NCM”) on the purchase date of such shares; and (ii) the average of the three lowest closing sale prices for the common stock traded on the NCM during the ten On September 17, 2021, the Company submitted a Regular Purchase Notice, resulting in the sale of 20,000 Purchase Shares to LPC for net proceeds of approximately $0.2 million. In May 2022, the Company provided LPC with notice of termination of the Purchase Agreement whereby no further shares are issuable under this agreement. |
SHARE-BASED COMPENSATION AND WA
SHARE-BASED COMPENSATION AND WARRANTS | 6 Months Ended |
Dec. 31, 2022 | |
SHARE-BASED COMPENSATION AND WARRANTS | |
SHARE-BASED COMPENSATION AND WARRANTS | NOTE 7 — 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 December 31, 2022 (in thousands): Plan Termination Number of Shares Description Date Authorized Outstanding Available 2015 Plan February 2020 30 30 — 2016 Plan October 2021 227 227 — 2019 Plan July 2029 200 200 — 2021 Plan March 2031 10,700 8,043 2,657 Total 11,157 8,500 2,657 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 the Company’s common stock through accumulated payroll deductions. 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. The first offering period concluded on December 31, 2022, and no purchases were made under the 2022 ESPP. Stock Options Outstanding The following table sets forth a summary of the activity under all of the Company’s stock option plans for the six months ended December 31, 2022 (shares in thousands): Shares Price (1) Term (2) Outstanding, June 30, 2022 8,506 $ 5.24 9.7 Grants to employees 288 2.12 Forfeited (294) 4.26 Outstanding, December 31, 2022 8,500 5.17 9.2 Vested, December 31, 2022 893 16.31 6.9 (1) Represents the weighted average exercise price. (2) Represents the weighted average remaining contractual term for the number of years until the stock options expire. For the six months ended December 31, 2022, the aggregate fair value of stock options granted for approximately 0.3 million shares of common stock amounted to $0.5 million or approximately $1.62 per share as of the grant dates. Fair value was computed using the Black-Scholes-Merton (“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 six months ended December 31, 2022, the fair value of stock options was estimated on the date of grant, with the following weighted-average assumptions: Market price of common stock on grant date $ 2.12 Expected volatility 91 % Risk free interest rate 3.9 % Expected term (years) 6.0 Dividend yield 0 % Share-based compensation expense for the three and six months ended December 31, 2022 and 2021 is included under the following captions in the unaudited condensed consolidated statements of operations (in thousands): Three Months Ended Six Months Ended December 31, December 31, 2022 2021 2022 2021 Research and development $ 730 $ 378 $ 1,600 $ 687 General and administrative 1,001 631 2,010 1,164 Total $ 1,731 $ 1,009 $ 3,610 $ 1,851 Unrecognized share-based compensation expense is approximately $20.2 million as of December 31, 2022. This amount is expected to be recognized over a weighted average period of 3.3 years. Warrants In connection with an underwritten offering in October 2021, the Company issued 1,661,461 pre-funded warrants (“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”). The 2021 PFWs may be exercised at any time by paying the exercise price of $0.01 per share, subject to certain ownership restrictions. In connection with a registered direct offering in May 2022, 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 (collectively, the “2022 PFWs”). As of December 31, 2022, all of the 2022 PFWs may be exercised at any time by paying the exercise price of $0.001 per share, subject to certain ownership restrictions. In addition, the Company has issued warrants in conjunction with various debt and equity financings and for services. As of December 30, 2022, all of the warrants were vested. For the six months ended December 31, 2022, no warrants were granted or exercised. Excluding the 2021 PFWs and the 2022 PFWs discussed above, the following table sets forth a summary of all other warrants for the six months ended December 31, 2022 (shares in thousands): Shares Price (1) Term (2) Outstanding, June 30, 2022 1,150 $ 22.83 4.2 Warrants granted — — Warrant expirations (5) 77.85 Outstanding, December 31, 2022 1,145 22.60 3.7 (1) Represents the weighted average exercise price. (2) Represents the weighted average remaining contractual term for the number of years until the warrants expire. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | NOTE 8 — COMMITMENTS AND CONTINGENCIES Licensing Commitments Please refer to Note 4 for further discussion of commitments to make milestone payments and to pay royalties under license agreements with XOMA and ActiveSite. 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 December 31, 2022, 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 known claims to determine whether a potential loss amount or a potential range of loss is probable and reasonably estimable under ASC 450, Contingencies |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 6 Months Ended |
Dec. 31, 2022 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 9 — RELATED PARTY TRANSACTIONS Related Party Licensing Agreement On September 15, 2020, the Company and Handok entered into an exclusive license agreement (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 to the Company 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 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 6. |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
INCOME TAXES | NOTE 10 — INCOME TAXES Income tax expense during interim periods is based on applying an estimated annualized effective income tax rate applied to the respective quarterly periods, adjusted for discrete tax items in the period in which they occur. The computation of the annualized estimated effective tax rate for each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating results for the year, projections of the proportion of income earned and taxed in various jurisdictions, permanent and temporary differences, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, more experience is obtained, additional information becomes known or as the tax environment changes. For the three and six months ended December 31, 2022 and 2021, the Company did not record any income tax benefit due to a full valuation allowance on its deferred tax assets. The Company did not have any material changes to its conclusions regarding valuation allowances for deferred income tax assets or uncertain tax positions for the three and six months ended December 31, 2022 and 2021. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Dec. 31, 2022 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | NOTE 11 — NET LOSS PER SHARE Basic net loss per share is computed by dividing net loss by the weighted average number of common shares, 2021 PFWs and 2022 PFWs outstanding during the period, without consideration for potentially dilutive securities. PFWs are included in the computation of basic and diluted net loss per share since the exercise price is negligible and all of the PFWs are fully vested and exercisable. Accordingly, the weighted average number of shares outstanding is computed as follows for the three and six months ended December 31, 2022 and 2021 (in thousands): Three Months Ended Six Months Ended December 31, December 31, 2022 2021 2022 2021 Common Stock 36,828 14,289 36,387 11,402 2021 PFWs 1,661 1,391 1,661 695 2022 PFWs: Class A PFWs 1,974 — 1,974 — Class B PFWs 10,947 — 10,947 — Total 51,410 15,680 50,969 12,097 For the three and six ended December 31, 2022 and 2021, basic and diluted net loss per share were the same since all other common stock equivalents were anti-dilutive. As of December 31, 2022 and 2021, the following outstanding 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): 2022 2021 Stock options 8,500 1,307 Warrants 1,145 1,187 Total 9,645 2,494 |
FINANCIAL INSTRUMENTS AND SIGNI
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS | 6 Months Ended |
Dec. 31, 2022 | |
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS | |
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS | NOTE 12 — 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 value 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 Company’s embedded derivative liabilities are classified under Level 3 of the hierarchy and are required to be measured and recorded at fair value on a recurring basis. Fair value is determined based on management’s assessment of the probability and timing of occurrence for the Exit Events discussed in Note 5 using a discount rate equal to the effective interest rate for the term A loan. The following table sets forth changes in the fair value of embedded derivative liabilities for the six months ended December 31, 2022 and 2021 (in thousands): 2022 2021 Fair value, beginning of period $ 407 $ 387 Loss (gain) from change in fair value 26 (4) Fair value, end of period $ 433 $ 383 Except for embedded derivative liabilities, the Company did not have any other assets or liabilities measured at fair value on a recurring basis as of December 31, 2022 and June 30, 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 December 31, 2022 and June 30, 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 six months ended December 31, 2022 and 2021, 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. The Company maintains its cash and cash equivalents at high-quality financial institutions. For the six months ended December 31, 2022, cash deposits have exceeded the amount of federal insurance provided on such deposits. As of December 31, 2022, the Company had cash and cash equivalents consisting of $115.1 million in a highly-liquid money market mutual fund and $31.6 million in checking and savings accounts at a financial institution. As of June 30, 2022 the Company had cash and cash $150.4 million in checking and savings accounts with the same financial institution. The Company has never experienced any losses related to its investments in cash and cash equivalents. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Dec. 31, 2022 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 13 — SUBSEQUENT EVENTS Employment Agreement Amendments On January 8, 2023, the Board of Directors approved certain amendments to the employment agreements of the Company’s chief executive officer and chief medical officer (the “Executive Officers”). The amendments provide that if either of the Executive Officers are 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 of the Executive Officers are terminated solely due to a change of control event, all of their 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. ActiveSite Milestone Payment Pursuant to the ActiveSite License Agreement discussed in Note 4, the next scheduled milestone payment for $3.0 million is due upon dosing of the first patient in a Phase 2 clinical study. On February 6, 2023, the Company dosed the first patient in its Phase 2 study, triggering the obligation to pay this milestone payment in February 2023. The Company will recognize the related licensing expense in the fiscal quarter ending March 31, 2023. |
NATURE OF OPERATIONS AND SUMM_2
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Dec. 31, 2022 | |
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Nature of Operations | Nature of Operations Rezolute, Inc. (the “Company”) is a clinical stage biopharmaceutical company developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company’s primary clinical assets consist of (i) RZ358, which is a potential treatment for congenital hyperinsulinism, an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas, and (ii) RZ402, which is an oral plasma kallikrein inhibitor (“PKI”) being developed as a potential therapy for the chronic treatment of diabetic macular edema. |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), the rules and regulations of the SEC for interim financial information, and the instructions to Form 10-Q and Article 8 of Regulation S-X. The condensed consolidated balance sheet as of June 30, 2022, has been derived from the Company’s audited consolidated financial statements. The unaudited interim financial statements should be read in conjunction with the Company’s 2022 Form 10-K, which contains the Company’s audited financial statements and notes thereto, together with the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal year ended June 30, 2022. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all information and footnote disclosures necessary for a comprehensive presentation of financial position, results of operations, and cash flows. It is management’s opinion, however, that all material adjustments (consisting of normal recurring adjustments) that are necessary for a fair financial statement presentation have been made. The interim results for the three and six months ended December 31, 2022 are not necessarily indicative of the financial condition and results of operations that may be expected for any future interim period or for the fiscal year ending June 30, 2023. |
Consolidation | 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. |
Use of Estimates | 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 unaudited condensed 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, the fair value of derivative liabilities, fair value of share-based payments, management’s assessment of going concern, and clinical trial accrued liabilities. Actual results could differ from those estimates. |
Risks and Uncertainties | 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, and the future impact of COVID-19. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are described in Note 1 to the financial statements in Item 8 of the 2022 Form 10-K. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Standard. In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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). Standard Required to be Adopted in Future Periods. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. Financial Instruments- Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) 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. |
OPERATING LEASES (Tables)
OPERATING LEASES (Tables) | 6 Months Ended |
Dec. 31, 2022 | |
OPERATING LEASES | |
Schedule of carrying value of ROU assets and operating lease liabilities | The carrying value of all right-of-use assets and operating lease liabilities are as follows (in thousands): December 31, June 30, 2022 2022 Right-of-use assets $ 2,294 $ 152 Operating lease liabilities: Current $ 167 $ 108 Long-term 2,196 80 Total $ 2,363 $ 188 |
Schedule of operating lease expense | For the three and six months ended December 31, 2022 and 2021, operating lease expense is included under the following captions in the accompanying condensed consolidated statements of operations (in thousands): Three Months Ended Six Months Ended December 31, December 31, 2022 2021 2022 2021 Research and development $ 115 $ 71 $ 192 $ 150 General and administrative 48 20 71 43 Total $ 163 $ 91 $ 263 $ 193 |
Schedule of Lessee operating lease liability maturity | Future payments under all operating lease agreements as of December 31, 2022 are as follows (in thousands): Fiscal year ending June 30, Remainder of fiscal year 2023 $ 109 2024 689 2025 627 2026 646 2027 666 Thereafter 224 Total lease payments 2,961 Less imputed interest (598) Present value of operating lease liabilities $ 2,363 |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 6 Months Ended |
Dec. 31, 2022 | |
SHAREHOLDERS' EQUITY | |
Summary of changes in stockholders' equity | The following table presents changes in shareholders’ equity for the three months ended December 31, 2022 and 2021: Additional Total Common Stock Paid-in Accumulated Shareholders' Shares Amount Capital Deficit Equity Three Months Ended December 31, 2022: Balances, September 30, 2022 36,827 $ 37 $ 372,082 $ (219,029) $ 153,090 Share-based compensation — — 1,731 — 1,731 Net loss — — — (13,556) (13,556) Balances, December 31, 2022 36,827 $ 37 $ 373,813 $ (232,585) $ 141,265 Three Months Ended December 31, 2021: Balances, September 30, 2021 8,640 $ 9 $ 197,524 $ (175,974) $ 21,559 Gross proceeds from issuance of equity securities for cash in Underwritten Offering: Common stock 6,147 6 39,950 — 39,956 Pre-Funded Warrants — — 10,783 — 10,783 Gross proceeds from issuance of common stock for cash in Registered Direct Offering 769 1 4,999 — 5,000 Underwriting discounts and other equity offering costs — — (3,449) — (3,449) Share-based compensation — — 1,009 — 1,009 Net loss — — — (12,593) (12,593) Balances, December 31, 2021 15,556 $ 16 $ 250,816 $ (188,567) $ 62,265 |
SHARE-BASED COMPENSATION AND _2
SHARE-BASED COMPENSATION AND WARRANTS (Tables) | 6 Months Ended |
Dec. 31, 2022 | |
SHARE-BASED COMPENSATION AND WARRANTS | |
Schedule of the Number of Shares Authorized, Outstanding, and Available for Future Grants Under Stock Option | 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 December 31, 2022 (in thousands): Plan Termination Number of Shares Description Date Authorized Outstanding Available 2015 Plan February 2020 30 30 — 2016 Plan October 2021 227 227 — 2019 Plan July 2029 200 200 — 2021 Plan March 2031 10,700 8,043 2,657 Total 11,157 8,500 2,657 |
Summary of the Stock Option Activity | The following table sets forth a summary of the activity under all of the Company’s stock option plans for the six months ended December 31, 2022 (shares in thousands): Shares Price (1) Term (2) Outstanding, June 30, 2022 8,506 $ 5.24 9.7 Grants to employees 288 2.12 Forfeited (294) 4.26 Outstanding, December 31, 2022 8,500 5.17 9.2 Vested, December 31, 2022 893 16.31 6.9 (1) Represents the weighted average exercise price. (2) Represents the weighted average remaining contractual term for the number of years until the stock options expire. |
Schedule of the Fair Value of Stock Options | For the six months ended December 31, 2022, the fair value of stock options was estimated on the date of grant, with the following weighted-average assumptions: Market price of common stock on grant date $ 2.12 Expected volatility 91 % Risk free interest rate 3.9 % Expected term (years) 6.0 Dividend yield 0 % |
Schedule of Share-Based Compensation Expense | Share-based compensation expense for the three and six months ended December 31, 2022 and 2021 is included under the following captions in the unaudited condensed consolidated statements of operations (in thousands): Three Months Ended Six Months Ended December 31, December 31, 2022 2021 2022 2021 Research and development $ 730 $ 378 $ 1,600 $ 687 General and administrative 1,001 631 2,010 1,164 Total $ 1,731 $ 1,009 $ 3,610 $ 1,851 |
Schedule of Warrant Activity | For the six months ended December 31, 2022, no warrants were granted or exercised. Excluding the 2021 PFWs and the 2022 PFWs discussed above, the following table sets forth a summary of all other warrants for the six months ended December 31, 2022 (shares in thousands): Shares Price (1) Term (2) Outstanding, June 30, 2022 1,150 $ 22.83 4.2 Warrants granted — — Warrant expirations (5) 77.85 Outstanding, December 31, 2022 1,145 22.60 3.7 (1) Represents the weighted average exercise price. (2) Represents the weighted average remaining contractual term for the number of years until the warrants expire. |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 6 Months Ended |
Dec. 31, 2022 | |
NET LOSS PER SHARE | |
Schedule of Weighted Average Shares Outstanding | Accordingly, the weighted average number of shares outstanding is computed as follows for the three and six months ended December 31, 2022 and 2021 (in thousands): Three Months Ended Six Months Ended December 31, December 31, 2022 2021 2022 2021 Common Stock 36,828 14,289 36,387 11,402 2021 PFWs 1,661 1,391 1,661 695 2022 PFWs: Class A PFWs 1,974 — 1,974 — Class B PFWs 10,947 — 10,947 — Total 51,410 15,680 50,969 12,097 |
Summary of Potential Common Stock Equivalents were Excluded from the Computation of Diluted Net Loss Per Share | As of December 31, 2022 and 2021, the following outstanding 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): 2022 2021 Stock options 8,500 1,307 Warrants 1,145 1,187 Total 9,645 2,494 |
FINANCIAL INSTRUMENTS AND SIG_2
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS (Tables) | 6 Months Ended |
Dec. 31, 2022 | |
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS | |
Summary of Changes in the Fair Value of the Company's Derivative Liabilities, Fair Value, Level 3 Inputs | The following table sets forth changes in the fair value of embedded derivative liabilities for the six months ended December 31, 2022 and 2021 (in thousands): 2022 2021 Fair value, beginning of period $ 407 $ 387 Loss (gain) from change in fair value 26 (4) Fair value, end of period $ 433 $ 383 |
NATURE OF OPERATIONS AND SUMM_3
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) | 6 Months Ended |
Dec. 31, 2022 subsidiary | |
NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Number of Wholly Owned Subsidiaries | 2 |
LIQUIDITY (Details)
LIQUIDITY (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jan. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2022 | |
Net loss | $ (13,556) | $ (12,593) | $ (23,387) | $ (20,429) | $ (41,100) | ||
Net cash used in operating activities | (15,082) | $ (13,538) | (39,600) | ||||
Accumulated deficit | (232,585) | (232,585) | (209,198) | ||||
Cash and cash equivalents | 146,746 | 146,746 | 150,410 | ||||
Current liabilities | $ 6,313 | 6,313 | $ 2,462 | ||||
XOMA (US) LLC [Member] | Phase 2 Clinical Trial RZ358 | Xoma License Agreement [Member] | |||||||
Milestone closing payment | $ 2,000 | ||||||
XOMA (US) LLC [Member] | Phase 3 Clinical Trial Rz 358 | Xoma License Agreement [Member] | Plan | |||||||
Milestone closing payment | $ 5,000 | 5,000 | |||||
ActiveSite Pharmaceuticals, Inc | Development And License Agreement [Member] | |||||||
Milestone closing payment | $ 1,000 | ||||||
ActiveSite Pharmaceuticals, Inc | Phase 2 Clinical Trial RZ402 | Development And License Agreement [Member] | Plan | |||||||
Milestone closing payment | $ 3,000 |
OPERATING LEASES (Details)
OPERATING LEASES (Details) $ in Thousands | 1 Months Ended | ||
Apr. 30, 2022 USD ($) ft² | Dec. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Lessee, Operating Lease, Liability, Payments, Due | $ 2,961 | ||
Right-of-use assets | 2,294 | $ 152 | |
Operating lease liabilities, net of current portion | $ 2,196 | $ 80 | |
Weighted average remaining lease term under operating leases | 4 years 7 months 6 days | ||
Weighted average discount rate for operating lease liabilities | 6.80% | ||
Corporate Headquarters | |||
Property, Plant and Equipment [Line Items] | |||
Lessee, Operating Lease, Operating Lease Space | ft² | 9,300 | ||
Lessee, Operating Lease, Liability, Payments, Due | $ 2,900 | ||
Lessee, Operating Lease, Abatement Period | 6 months | ||
Lessee, Operating Lease, Furniture And Equipment Allowance | $ 100 | ||
Lessee, Operating Lease, Term of Contract | 60 months | ||
Lessee, Operating Lease, Base Rent Expense | $ 48,000 | ||
Right-of-use assets | 2,300 | ||
Operating lease liabilities, net of current portion | $ 2,200 |
OPERATING LEASES - Assets and o
OPERATING LEASES - Assets and operating lease liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jun. 30, 2022 |
Carrying value of right-of-use assets and operating lease liabilities | ||
Right-of-use assets, net | $ 2,294 | $ 152 |
Operating lease liabilities: | ||
Current | 167 | 108 |
Long-term | 2,196 | 80 |
Total | $ 2,363 | $ 188 |
OPERATING LEASES - Operating le
OPERATING LEASES - Operating lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | ||||
Operating lease expense | $ 163 | $ 91 | $ 263 | $ 193 |
Research and development | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease expense | 115 | 71 | 192 | 150 |
General and administrative | ||||
Lessee, Lease, Description [Line Items] | ||||
Operating lease expense | $ 48 | $ 20 | $ 71 | $ 43 |
OPERATING LEASES - Future Opera
OPERATING LEASES - Future Operating Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jun. 30, 2022 |
Future lease payments related to operating lease agreements | ||
Remainder of fiscal year 2023 | $ 109 | |
2024 | 689 | |
2025 | 627 | |
2026 | 646 | |
2027 | 666 | |
Thereafter | 224 | |
Total lease payments | 2,961 | |
Less imputed interest | (598) | |
Present value of operating lease liabilities | $ 2,363 | $ 188 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | ||
Aug. 04, 2017 | Jan. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2022 | |
XOMA (US) LLC [Member] | Xoma License Agreement [Member] | Upon Clinical and Regulatory Milestones | Maximum | ||||
License Agreements | ||||
Milestone closing payment | $ 35 | |||
XOMA (US) LLC [Member] | Xoma License Agreement [Member] | After Clinical and Regulatory Milestones | Maximum | ||||
License Agreements | ||||
Milestone closing payment | $ 185 | |||
XOMA (US) LLC [Member] | Phase 2 Clinical Trial RZ358 | Xoma License Agreement [Member] | ||||
License Agreements | ||||
Milestone closing payment | 2 | |||
XOMA (US) LLC [Member] | Phase 3 Clinical Trial Rz 358 | Xoma License Agreement [Member] | Plan | ||||
License Agreements | ||||
Milestone closing payment | $ 5 | 5 | ||
ActiveSite Pharmaceuticals, Inc | ||||
License Agreements | ||||
Royalties percentage | 2% | |||
ActiveSite Pharmaceuticals, Inc | Development And License Agreement [Member] | ||||
License Agreements | ||||
Milestone closing payment | $ 1 | |||
ActiveSite Pharmaceuticals, Inc | Development And License Agreement [Member] | Plan | Maximum | ||||
License Agreements | ||||
Maximum Amount of Milestone Events | $ 46.5 | |||
ActiveSite Pharmaceuticals, Inc | Phase 2 Clinical Trial RZ402 | Development And License Agreement [Member] | Plan | ||||
License Agreements | ||||
Milestone closing payment | $ 3 |
EMBEDDED DERIVATIVE LIABILITY (
EMBEDDED DERIVATIVE LIABILITY (Details) $ in Millions | Apr. 14, 2021 USD ($) tranche |
Debt Instrument [Line Items] | |
Number of Tranches | tranche | 3 |
Loan and security agreement | |
Debt Instrument [Line Items] | |
Maximum borrowing capacity | $ 30 |
Exit fee on the funded principal balance | 4% |
Percentage Of Entity's Shares Held By Investors | 35% |
Term A loan | Loan and security agreement | |
Debt Instrument [Line Items] | |
Gross proceeds from issuance of debt | $ 15 |
Term B and C Loan | Loan and security agreement | |
Debt Instrument [Line Items] | |
Remaining borrowing capacity | $ 15 |
SHAREHOLDERS' EQUITY - Changes
SHAREHOLDERS' EQUITY - Changes in Shareholders' Equity (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Oct. 15, 2021 | Nov. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 30, 2022 | |
Balance | $ 153,090 | $ 21,559 | $ 149,471 | $ 26,099 | $ 26,099 | ||
Underwriting commissions, discounts and other equity offering costs | (3,449) | (759) | (4,136) | ||||
Share-based compensation | 1,731 | 1,009 | 3,610 | 1,851 | |||
Net loss | (13,556) | (12,593) | (23,387) | (20,429) | (41,100) | ||
Balance | 141,265 | 62,265 | 141,265 | 62,265 | 149,471 | ||
2021 Pre-Funded Warrants. | |||||||
Gross proceeds from issuance of common stock for cash | 10,783 | ||||||
2021 Underwritten Public Offering | |||||||
Gross proceeds from issuance of common stock for cash | 39,956 | 39,956 | |||||
Gross proceeds from issuance of common stock for cash (in shares) | 6,030,847 | 116,266 | |||||
2021 Underwritten Public Offering | 2021 Pre-Funded Warrants. | |||||||
Gross proceeds from issuance of common stock for cash | 10,783 | ||||||
Registered Direct Offering 2021 [Member] | |||||||
Gross proceeds from issuance of common stock for cash | 5,000 | 5,000 | |||||
Gross proceeds from issuance of common stock for cash (in shares) | 769,231 | ||||||
Common Stock | |||||||
Balance | $ 37 | $ 9 | $ 34 | $ 8 | $ 8 | ||
Balance (in shares) | 36,827,000 | 8,640,000 | 33,582,000 | 8,352,000 | 8,352,000 | ||
Balance | $ 37 | $ 16 | $ 37 | $ 16 | $ 34 | ||
Balance (in shares) | 36,827,000 | 15,556,000 | 36,827,000 | 15,556,000 | 33,582,000 | ||
Common Stock | 2021 Underwritten Public Offering | |||||||
Gross proceeds from issuance of common stock for cash | $ 6 | $ 6 | |||||
Gross proceeds from issuance of common stock for cash (in shares) | 6,147,000 | 6,147,000 | |||||
Common Stock | Registered Direct Offering 2021 [Member] | |||||||
Gross proceeds from issuance of common stock for cash | $ 1 | $ 1 | |||||
Gross proceeds from issuance of common stock for cash (in shares) | 769,000 | 769,000 | |||||
Additional Paid-in Capital | |||||||
Balance | $ 372,082 | $ 197,524 | $ 358,635 | $ 194,229 | $ 194,229 | ||
Underwriting commissions, discounts and other equity offering costs | (3,449) | (759) | (4,136) | ||||
Share-based compensation | 1,731 | 1,009 | 3,610 | 1,851 | |||
Balance | 373,813 | 250,816 | 373,813 | 250,816 | 358,635 | ||
Additional Paid-in Capital | 2021 Pre-Funded Warrants. | |||||||
Gross proceeds from issuance of common stock for cash | 10,783 | ||||||
Additional Paid-in Capital | 2021 Underwritten Public Offering | |||||||
Gross proceeds from issuance of common stock for cash | 39,950 | 39,950 | |||||
Additional Paid-in Capital | 2021 Underwritten Public Offering | 2021 Pre-Funded Warrants. | |||||||
Gross proceeds from issuance of common stock for cash | 10,783 | ||||||
Additional Paid-in Capital | Registered Direct Offering 2021 [Member] | |||||||
Gross proceeds from issuance of common stock for cash | 4,999 | 4,999 | |||||
Accumulated Deficit | |||||||
Balance | (219,029) | (175,974) | (209,198) | (168,138) | (168,138) | ||
Net loss | (13,556) | (12,593) | (23,387) | (20,429) | |||
Balance | $ (232,585) | $ (188,567) | $ (232,585) | $ (188,567) | $ (209,198) |
SHAREHOLDERS' EQUITY - July 202
SHAREHOLDERS' EQUITY - July 2022 Financing (Details) - July 2022 Financing shares in Millions, $ in Millions | 1 Months Ended |
Jul. 31, 2022 USD ($) shares | |
Class of Stock [Line Items] | |
Proceeds from Issuance of Common Stock | $ 12.3 |
Gross proceeds from issuance of common stock for cash (in shares) | shares | 3.2 |
Underwriting discounts and commissions expense | $ 0.8 |
Proceeds From Issuance Of Common Stock, Net Of Underwriting Discounts And Commissions | $ 11.5 |
SHAREHOLDERS' EQUITY - Underwri
SHAREHOLDERS' EQUITY - Underwritten Public Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | ||||
Oct. 15, 2021 | Nov. 30, 2021 | Oct. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2022 | Jun. 30, 2022 | |
Class of Stock [Line Items] | ||||||
Warrant price (per share) | $ 22.60 | $ 22.83 | ||||
2021 Pre-Funded Warrants. | ||||||
Class of Stock [Line Items] | ||||||
Warrants granted (In shares) | 1,661,461 | |||||
Number of shares of common stock called by warrants issued | 1,661,461 | |||||
Warrant price (per share) | $ 0.01 | $ 0.01 | ||||
Proceeds from warrants issued | $ 10,800 | $ 10,800 | ||||
Underwritten Public Offering [Member] | ||||||
Class of Stock [Line Items] | ||||||
Gross proceeds from issuance of common stock for cash (in shares) | 6,030,847 | 116,266 | ||||
Sale of stock, price per share | $ 6.50 | |||||
Gross proceeds from sale of equity | $ 50,000 | |||||
Proceeds from issuances of common stock | $ 39,200 | $ 800 | $ 50,738 | |||
Underwriting discounts and commissions ( In percentage) | 6% | |||||
Other offering costs | $ 300 | |||||
Underwriting Discounts And Commissions Expense | $ 3,300 | |||||
Underwriters option period | 30 days | |||||
Maximum number of additional shares issued | 1,153,845 | |||||
Net cash proceeds | $ 46,700 | |||||
Underwritten Public Offering [Member] | 2021 Pre-Funded Warrants. | ||||||
Class of Stock [Line Items] | ||||||
Warrants granted (In shares) | 1,661,461 | |||||
Number of shares of common stock called by warrants issued | 1,661,461 | |||||
Warrant price (per share) | $ 6.49 | |||||
Proceeds from warrants issued | $ 10,800 |
SHAREHOLDERS' EQUITY - Pre-Fund
SHAREHOLDERS' EQUITY - Pre-Funded Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | ||
Oct. 15, 2021 | Oct. 31, 2021 | Dec. 31, 2022 | Jun. 30, 2022 | |
Class of Stock [Line Items] | ||||
Warrant price (per share) | $ 22.60 | $ 22.83 | ||
2021 Pre-Funded Warrants. | ||||
Class of Stock [Line Items] | ||||
Warrant price (per share) | $ 0.01 | $ 0.01 | ||
Proceeds from warrants issued | $ 10.8 | $ 10.8 | ||
Minimum Period For Increase Or Decrease In Ownership Percentage | 61 days | |||
Warrants exercised | 0 | |||
2021 Pre-Funded Warrants. | Maximum | ||||
Class of Stock [Line Items] | ||||
Warrants Designated Percentage Elected By Holder | 19.99% | |||
2021 Pre-Funded Warrants. | Minimum | ||||
Class of Stock [Line Items] | ||||
Warrants Designated Percentage Elected By Holder | 4.99% |
SHAREHOLDERS' EQUITY - Register
SHAREHOLDERS' EQUITY - Registered Direct Offering (Details) - 2021 Registered Direct Offering - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Oct. 27, 2021 | Oct. 15, 2021 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||
Number of shares issued | 769,231 | ||
Sale of stock, price per share | $ 6.50 | ||
Proceeds from issuance of common stock | $ 5,000 | $ 5,000 |
SHAREHOLDERS' EQUITY - Equity D
SHAREHOLDERS' EQUITY - Equity Distribution Agreement (Details) - Equity Distribution Agreement - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended |
Dec. 31, 2020 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||
Issuance of common stock for cash | $ 50,000 | $ 1,519 |
Underwriting discounts and commissions ( In percentage) | 3% | |
Number of shares issued | 138,388 | |
Proceeds from issuance of common stock | $ 1,519 |
SHAREHOLDERS' EQUITY - LPC Purc
SHAREHOLDERS' EQUITY - LPC Purchase Agreement (Details) - LPC Purchase Agreement $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |
Sep. 17, 2021 USD ($) shares | Aug. 31, 2021 USD ($) item $ / shares shares | Dec. 31, 2021 USD ($) | |
Class of Stock [Line Items] | |||
Gross proceeds from issuance of common stock for cash | $ | $ 1,172 | ||
Gross proceeds from issuance of common stock for cash (in shares) | shares | 20,000 | 95,708 | |
Proceeds from issuance of common stock | $ | $ 200 | $ 1,000 | $ 1,171 |
Shares issue price | $ / shares | $ 10.45 | ||
Commitment shares issued | shares | 33,799 | ||
Number of lowest closing sale prices for determining regular purchase share price | item | 3 | ||
Number of consecutive business days for selecting three lowest closing sale prices | 10 days | ||
Common Stock | |||
Class of Stock [Line Items] | |||
Maximum number of shares purchased | shares | 25,000 | ||
Maximum purchase price committed obligation | $ | $ 2,000 | ||
Common Stock | Maximum | |||
Class of Stock [Line Items] | |||
Gross proceeds from issuance of common stock for cash | $ | $ 20,000 | ||
Gross proceeds from issuance of common stock for cash (in shares) | shares | 1,669,620 |
SHARE-BASED COMPENSATION AND _3
SHARE-BASED COMPENSATION AND WARRANTS - Stock Option Plans (Details) - shares shares in Thousands | Dec. 31, 2022 | Jun. 30, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized | 11,157 | |
Number of shares outstanding | 8,500 | 8,506 |
Number of shares available | 2,657 | |
2015 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized | 30 | |
Number of shares outstanding | 30 | |
2016 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized | 227 | |
Number of shares outstanding | 227 | |
2019 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized | 200 | |
Number of shares outstanding | 200 | |
2021 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized | 10,700 | |
Number of shares outstanding | 8,043 | |
Number of shares available | 2,657 |
SHARE-BASED COMPENSATION AND _4
SHARE-BASED COMPENSATION AND WARRANTS - Stock Options Outstanding (Details) - $ / shares shares in Thousands | 6 Months Ended | 12 Months Ended |
Dec. 31, 2022 | Jun. 30, 2022 | |
Number of Options | ||
Outstanding, beginning of fiscal year | 8,506 | |
Granted | 288 | |
Forfeited | (294) | |
Outstanding, end of fiscal year | 8,500 | 8,506 |
Vested, end of fiscal year | 893 | |
Weighted Average Exercise Price | ||
Outstanding, beginning of fiscal year | $ 5.24 | |
Granted | 2.12 | |
Forfeited | 4.26 | |
Outstanding, end of fiscal year | 5.17 | $ 5.24 |
Vested, end of fiscal year | $ 16.31 | |
Weighted Average Remaining Contractual Life | ||
Remaining contractual term (years) | 9 years 2 months 12 days | 9 years 8 months 12 days |
Vested | 6 years 10 months 24 days |
SHARE-BASED COMPENSATION AND _5
SHARE-BASED COMPENSATION AND WARRANTS - Weighted Average Assumptions (Details) - Time-Based | 6 Months Ended |
Dec. 31, 2022 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Market price of common stock on grant date | $ 2.12 |
Expected volatility | 91% |
Risk free interest rate | 3.90% |
Expected term (years) | 6 years |
Dividend yield | 0% |
SHARE-BASED COMPENSATION AND _6
SHARE-BASED COMPENSATION AND WARRANTS - Share Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Compensation cost | $ 1,731 | $ 1,009 | $ 3,610 | $ 1,851 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Compensation cost | 730 | 378 | 1,600 | 687 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Compensation cost | $ 1,001 | $ 631 | $ 2,010 | $ 1,164 |
SHARE-BASED COMPENSATION AND _7
SHARE-BASED COMPENSATION AND WARRANTS - Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | |||
Oct. 15, 2021 | May 31, 2022 | Oct. 31, 2021 | Dec. 31, 2022 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants outstanding, beginning of fiscal year (In shares) | 1,150,000 | ||||
Warrant expirations (In shares) | (5,000) | ||||
Warrants outstanding, fiscal year (In shares) | 1,145,000 | ||||
Weighted average exercise price( Per share) | $ 22.83 | ||||
Warrant expirations (in dollars per share) | 77.85 | ||||
Weighted average exercise price (Per share) | $ 22.60 | ||||
Weighted average remaining contractual term | 3 years 8 months 12 days | 4 years 2 months 12 days | |||
Warrants granted or exercised | 0 | ||||
2021 Pre-Funded Warrants. | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Pre-funded warrants to purchase shares of common stock | 1,661,461 | ||||
Shares issue price | $ 6.49 | ||||
Proceeds from warrants issued | $ 10.8 | $ 10.8 | |||
Warrants granted (In shares) | 1,661,461 | ||||
Weighted average exercise price (Per share) | $ 0.01 | $ 0.01 | |||
2022 Pre-Funded Warrants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Pre-funded warrants to purchase shares of common stock | 12,921,055 | ||||
Shares issue price | $ 3.799 | ||||
Weighted average exercise price (Per share) | $ 0.001 | ||||
Class A Warrants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants granted (In shares) | 1,973,684 | ||||
Class B Warrants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Warrants granted (In shares) | 10,947,371 |
SHARE-BASED COMPENSATION AND _8
SHARE-BASED COMPENSATION AND WARRANTS - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | |
Dec. 31, 2022 | Jun. 16, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted | 288,000 | |
Weighted average grant date fair value, granted | $ 1.62 | |
Employee service share-based compensation, nonvested awards, total compensation cost not yet recognized, stock options | $ 20.2 | |
Estimated fair value of stock options | $ 0.5 | |
Expected to be recognized over a remaining weighted average period | 3 years 3 months 18 days | |
Employee Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares reserved for purchase | 500,000 | |
Shares purchases | 0 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - Handok, Inc. - Handok License Agreement - USD ($) $ in Thousands | 6 Months Ended | |
Sep. 15, 2020 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | ||
License term (in years) | 20 years | |
Milestone payments | $ 500 | |
Transfer price (in percent) | 70% | |
Milestone payments earned | $ 0 |
NET LOSS PER SHARE - Weighted A
NET LOSS PER SHARE - Weighted Average Number of Shares Outstanding (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average number of shares outstanding | 51,410 | 15,680 | 50,969 | 12,097 |
2021 Pre-Funded Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average number of shares outstanding | 1,661 | 1,391 | 1,661 | 695 |
Class A Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average number of shares outstanding | 1,974 | 1,974 | ||
Class B Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average number of shares outstanding | 10,947 | 10,947 | ||
Common Stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Weighted average number of shares outstanding | 36,828 | 14,289 | 36,387 | 11,402 |
NET LOSS PER SHARE - Anti-dilut
NET LOSS PER SHARE - Anti-dilutive (Details) - shares shares in Thousands | 6 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
NET LOSS PER SHARE | ||
Total | 9,645 | 2,494 |
Stock options | ||
NET LOSS PER SHARE | ||
Total | 8,500 | 1,307 |
Warrants. | ||
NET LOSS PER SHARE | ||
Total | 1,145 | 1,187 |
FINANCIAL INSTRUMENTS AND SIG_3
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS - Summary of Changes in the Fair Value (Details) - Embedded derivative liability - USD ($) $ in Thousands | 6 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at the beginning | $ 407 | $ 387 |
Loss from change in fair value | $ 26 | $ (4) |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Gain (Loss) on Derivative Instruments, Net, Pretax | Gain (Loss) on Derivative Instruments, Net, Pretax |
Balance at the end | $ 433 | $ 383 |
FINANCIAL INSTRUMENTS AND SIG_4
FINANCIAL INSTRUMENTS AND SIGNIFICANT CONCENTRATIONS - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Dec. 31, 2022 | Jun. 30, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Concentration Risk, Credit Risk, Uninsured Deposits | 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. For the six months ended December 31, 2022, cash deposits have exceeded the amount of federal insurance provided on such deposits. | |
Cash and cash equivalents | $ 146,746 | $ 150,410 |
Money Market Mutual Fund | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Cash and cash equivalents | 115,100 | |
Checking and Savings Accounts | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Cash and cash equivalents | $ 31,600 | $ 150,400 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Feb. 06, 2023 | Jan. 08, 2023 | Dec. 31, 2020 | |
ActiveSite Pharmaceuticals, Inc | Development And License Agreement [Member] | |||
Subsequent Event [Line Items] | |||
Milestone closing payment | $ 1 | ||
Subsequent Event | ActiveSite Pharmaceuticals, Inc | Phase 2 Clinical Trial RZ402 | Development And License Agreement [Member] | |||
Subsequent Event [Line Items] | |||
Milestone closing payment | $ 3 | ||
Subsequent Event | Executive Officers | Minimum | Termination Outside of Change in Control Event | |||
Subsequent Event [Line Items] | |||
Vesting period | 12 months | ||
Option exercisable Term | 6 months | ||
Subsequent Event | Executive Officers | Minimum | Termination Due to Change in Control Event | |||
Subsequent Event [Line Items] | |||
Option exercisable Term | 6 months | ||
Subsequent Event | Executive Officers | Maximum | Termination Outside of Change in Control Event | |||
Subsequent Event [Line Items] | |||
Vesting period | 18 months | ||
Option exercisable Term | 12 months | ||
Subsequent Event | Executive Officers | Maximum | Termination Due to Change in Control Event | |||
Subsequent Event [Line Items] | |||
Option exercisable Term | 12 months | ||
Subsequent Event | Chief Medical Officer | Termination Outside of Change in Control Event | |||
Subsequent Event [Line Items] | |||
Vesting period | 12 months | ||
Option exercisable Term | 6 months | ||
Severance benefit equivalent to salary period | 12 months | ||
Insurance coverage period | 12 months | ||
Subsequent Event | Chief Medical Officer | Termination Due to Change in Control Event | |||
Subsequent Event [Line Items] | |||
Severance benefit equivalent to salary period | 18 months | ||
Insurance coverage period | 18 months |