Rezolute Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of Operations
Rezolute, Inc. (the “Company”) is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism. The Company’s primary clinical assets consist of (i) ersodetug (formerly known as RZ358), which is a potential treatment for all forms of hyperinsulinism, including 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, 2024, 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 2024 Form 10-K, which contains the Company’s audited financial statements and notes thereto, together with Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal year ended June 30, 2024.
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 months ended September 30, 2024, 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, 2025.
Consolidation
The Company hastwo 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, determination if an allowance for credit losses is required for marketable debt securities, the fair value of an embedded derivative liability, fair value of share-based compensation, management’s assessment of going concern, and estimates related to 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.
Significant Accounting Policies
The Company’s significant accounting policies are described in Note 1 to the financial statements in Item 8 of the 2024 Form 10-K.
Recent Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which improves reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. ASU 2023-07 expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items and interim disclosures of a reportable segment’s profit or loss and assets. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments should be applied on a retrospective basis to all periods presented. The Company is evaluating the effect of adopting ASU 2023-07 and does not expect the amendments to have a material impact on its consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):Improvements to Income Tax Disclosures (“ASU 2023-09”), which expands income tax disclosures including changes in the rate reconciliation and income taxes paid information. This ASU is intended to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 is effective for annual periods beginning after December 15, 2024, and early adoption is permitted. The Company has not determined the timing for adoption of this standard.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not currently expected to have a material impact on the Company’s financial statements upon adoption.
NOTE 2 — LIQUIDITY
As a clinical stage business, the Company has not yet generated any revenues and had an accumulated deficit of $344.8 million as of September 30, 2024. For the three months ended September 30, 2024, the Company incurred a net loss of $15.4 million and net cash used in operating activities amounted to $16.0 million. For the fiscal year ended June 30, 2024, the Company incurred a net loss of $68.5 million and net cash used in operating activities amounted to $57.4 million. As of September 30, 2024, the Company’s capital resources consist of cash and cash equivalents of $10.5 million, short-term investments in marketable debt securities of $97.8 million and long-term investments in marketable debt securities of $9.6 million.
As discussed in Note 7, the Company completed the 2024 Private Placement in July 2024 that resulted in the sale of 1.5 million shares of common stock for net cash proceeds of $6.0 million.
As of September 30, 2024, the Company has total liabilities of $10.0 million, including current liabilities of $8.0 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 last patient in a Phase 3 clinical trial for ersodetug. The commitment to pay the last patient dosing milestone of $5.0 million for the ersodetug Phase 3 clinical trial is expected to be recognized as a liability and corresponding expense within 12 months.
Management believes the Company’s existing cash and cash equivalents and investments in marketable debt securities will be adequate to meet the Company’s contractual obligations and carry out ongoing clinical trials and other planned activities through November 2025, at a minimum.
NOTE 3 —INVESTMENTS IN MARKETABLE DEBT SECURITIES
Investments in marketable debt securities are accounted for as available-for-sale investments at fair value and consist of the following (in thousands):
| | | | | | |
|---|---|---|---|---|---|
| · September 30, · · June 30, | |||||
| · 2024 · 2024 | |||||
| Short-term investments | $97,801 | | $56,478 | ||
| Long-term investments | | 9,552 | | | 263 |
| Total investments | $107,353 | | $56,741 | ||
The Company only invests in liquid, high quality debt securities. Nonetheless, 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 exposure due to an adverse shift in interest rates, the Company generally invests in securities with expected maturities oftwo years or less while maintaining a weighted average maturity ofone year or less. As of September 30, 2024, investments in marketable debt securities with an aggregate fair value of $97.8 million are scheduled to mature during the 12-month period ending September 30, 2025. All remaining investments, with an aggregate fair value of $9.6 million, are scheduled to mature during the 12-month period ending September 30, 2026.
During the three months ended September 30, 2024, marketable debt securities for $23.8 million matured and were reinvested in additional marketable debt securities. The Company used $73.2 million of cash and cash equivalents to purchase investments in marketable debt securities of the proceeds during the three months ended September 30, 2024. The Company did not sell any marketable debt securities prior to the scheduled maturity dates for the three months ended September 30, 2024.
Accrued interest receivable on all marketable debt securities amounted to $0.5 million and $0.4 million as of September 30, 2024 and June 30, 2024, respectively. Accrued interest receivable is included in other current assets in the accompanying condensed consolidated balance sheets.
For the three months ended September 30, 2024, the Company didnot recognize any allowance for credit losses or other than temporary impairment related to investments in marketable debt securities. The following table summarizes the cumulative 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 September 30, 2024 (in thousands):
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Gross Unrealized · · · · | |||||||||||||
| · · Amortized Cost · Gains · Losses · Fair Value · | |||||||||||||
| Corporate commercial paper | | $31,485 | | $37 | | $— | | $31,522 | | ||||
| Obligations of U.S. government agencies | | | 5,253 | | | 24 | | | — | | | 5,277 | |
| U.S. Treasury obligations | | | 13,651 | | | 14 | | | (1) | | | 13,664 | |
| Corporate notes and bonds | | | 56,675 | | | 217 | | | (2) | | | 56,890 | |
| Total | | $107,064 | | $292 | | $(3) | | $107,353 | | ||||
NOTE 4 — OPERATING LEASES
The carrying values of all right-of-use assets and operating lease liabilities is as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · June 30, | ||||||
| · 2024 · 2024 | ||||||
| Right-of-use assets | | $1,751 | | $1,880 | ||
| | | | | | | |
| Operating lease liabilities: | | | ||||
| Current | | $584 | | $568 | ||
| Long-term | | 1,499 | | 1,660 | ||
| Total | | $2,083 | | $2,228 | ||
For the three months ended September 30, 2024 and 2023, operating lease expense is included under the following captions in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| · · 2024 · 2023 | ||||
| Research and development | | $119 | | $131 |
| General and administrative | | 48 | | 42 |
| Total | | $167 | | $173 |
As of September 30, 2024, the weighted average remaining lease term under operating leases was 3.0 years, and the weighted average discount rate for operating lease liabilities was 7.1%. Future cash payments under all operating lease agreements as of September 30, 2024 are as follows (in thousands):
| | | | |
|---|---|---|---|
| Fiscal year ending June 30, · | |||
| Remainder of fiscal year 2025 | | $564 | |
| 2026 | | | 770 |
| 2027 | | | 750 |
| Thereafter | | | 224 |
| Total lease payments | | | 2,308 |
| Less imputed interest | | (225) | |
| Present value of operating lease liabilities | | $2,083 | |
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 or RZ358, now ersodetug) for all indications.
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 Phase 2b Clinical Trial for ersodetug. In April 2024, the Company was required to make a milestone payment under the XOMA License Agreement of $5.0 million that became due upon dosing of the first patient in the Company’s Phase 3 Clinical Trial for ersodetug. 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 $30.0 million. After the clinical and regulatory milestones, the Company will be required, upon the future commercialization of ersodetug, 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 Company records a liability and corresponding expense for milestone payments under license agreements in the period that the milestone event is achieved. The next milestone payment of $5.0 million will be due upon dosing of the last patient in either of the Phase 3 clinical trials for ersodetug.
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 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 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 dosing of the first 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. 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.
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 Agreement was not impacted by the 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 $0.5 million as of September 30, 2024 and June 30, 2024. 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 this embedded derivative liability is reassessed at the end of each reporting period with changes in fair value recognized as a non-operating gain or loss.
NOTE 7 — SHAREHOLDERS’ EQUITY
Pre-Funded Warrants
Between October 2021 and June 2024, the Company issued fully vested pre-funded warrants (“PFWs”) exercisable to purchase an aggregate of 21.3 million shares of common stock. As of September 30, 2024, all outstanding PFWs meet the requirements to be classified in shareholders’ equity under the captionadditional paid-in capital. The 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 exercise prices of the PFWs are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting holders of common stock. In the event of certain fundamental corporate transactions, the holders of the PFWs are entitled to receive the kind and amount of securities, cash or other property that the holders would have received had they exercised the PFWs immediately prior to such transaction.
The PFWs are exercisable at any time, subject to the then effective ownership blocker percentage (the “OBP”) as elected by each of the holders of PFWs. The OBP is a percentage designated by the holders whereby the PFWs cannot be exercised if, after giving effect thereto, the holder would beneficially own more than the designated OBP. However, upon at least 61 days’ prior notice to the Company, any holder of PFWs may elect to increase or decrease the OBP to any other percentage not to exceed 19.99%. Assuming the holders
comply with the respective OBP terms, all of the PFWs may be exercised at any time by paying the respective exercise price or electing to exercise on a cashless basis.
As of June 30, 2024, the Company had an aggregate of 15,020,371 PFWs that were outstanding. The following table summarizes PFW activity for the three months ended September 30, 2024:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| | 2021 | | 2022 | | Exchange | | 2024 | | |
| | PFWs | | PFWs | | PFWs | | PFWs | | Total |
| Outstanding, June 30, 2024 | 123,000 | (1) | 8,147,371 | (2) | 3,000,000 | (3) | 3,750,000 | (4) | 15,020,371 |
| Cashless exercise of PFWs: | | | | | | | | | |
| Shares surrendered for exercise price | — | | — | | (131) | | — | | (131) |
| Shares of common stock issued | — | | — | | (610,273) | | — | | (610,273) |
| Outstanding, September 30, 2024 | 123,000 | | 8,147,371 | | 2,389,596 | | 3,750,000 | | 14,409,967 |
| (1) | In connection with an underwritten offering in October 2021, PFWs were issued to purchase 1,661,461 shares of common stock at an issuance price of $6.49 per share (the “2021 PFWs”). The exercise price of the 2021 PFWs is $0.01 per share. |
| (2) | 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 (the “2022 PFWs”). The exercise price of the 2022 PFWs is $0.001 per share. For the fiscal year ended June 30, 2024, the holders elected cashless exercises for a total of 4,773,684 of the 2022 PFWs resulting in 8,147,371 shares that remained outstanding as of June 30, 2024. The 2022 PFWs were classified within shareholders’ equity for the entirety of the fiscal quarter ended September 30, 2024 and the fiscal year ended June 30, 2024. |
| (3) | As discussed below under the caption Exchange Agreement, the Company issued 3,000,000 Exchange PFWs on March 8, 2024. The exercise price of the Exchange PFWs is $0.001 per share. The Exchange PFWs were initially classified as a derivative liability until May 13, 2024 when the terms were amended to permit reclassification within shareholders’ equity. |
| (4) | As discussed below under the caption 2024 Underwritten Offering, the Company issued 2024 PFWs for the purchase of 3,750,000 shares of common stock on June 17, 2024. The exercise price of the 2024 PFWs is $0.001 per share. |
2024 Private Placement
In June 2024, the Company entered into a securities purchase agreement (the “2024 SPA”) with Handok, Inc. and one other investor relating to a private placement (the “2024 Private Placement”), pursuant to which 1,500,000 shares of common stock were issued at a purchase price of $4.00 per share. Closing of the 2024 Private Placement occurred in July 2024, resulting in net proceeds of $6.0 million after deduction of offering costs.
2024 Underwritten Offering
On June 13, 2024, the Company entered into an underwriting agreement with Jefferies LLC and Cantor Fitzgerald & Co. (the “Underwriters”) for the planned issuance and sale of equity securities in an underwritten public offering (the “2024 Underwritten Offering”). The 2024 Underwritten Offering provided for the issuance of (i)11,250,000 shares of common stock at a price of $4.00 per share for gross proceeds of $45.0 million, and (ii) pre-funded warrants to purchase 3,750,000 shares of common stock at a public offering price of $3.999 per pre-funded warrant (the “2024 PFWs”) for gross proceeds of $15.0 million. The Company granted the 2024 Underwriters a 30-day option to purchase up to an additional 2,250,000 shares of its common stock in the 2024 Underwritten Offering at a public offering price of $4.00 per share, less underwriting commissions (the “2024 Underwriters’ Option”). The Underwriters’ Option was partially exercised for 1,786,589 shares of common stock for gross proceeds of $7.1 million. Closing occurred on June 24, 2024, whereby the aggregate gross proceeds from the 2024 Underwritten Offering amounted to $67.1 million before deductions for underwriting commissions of 6.0% of the gross proceeds and other offering costs of approximately $0.5 million. After deducting total offering costs of $4.5 million, the net proceeds of the 2024 Underwritten Offering amounted to approximately $62.6 million.
Exchange Agreement
On March 8, 2024, the Company entered into a securities exchange agreement (the “Exchange Agreement”) with certain of its stockholders (the “Exchanging Shareholders”), whereby the Company purchased 3,000,000 shares of common stock representing approximately 7% of outstanding shares with an aggregate fair value of $5,700,000 (the “Retired Shares”) from the Exchanging Shareholders. The Retired Shares were immediately cancelled whereby they will remain as authorized shares for future issuance in accordance with Nevada law. Consideration for the acquisition of the Retired Shares consisted of (i) a cash payment to the Exchanging Shareholders of $3,000, and (ii) the issuance of pre-funded warrants (the “Exchange PFWs”) to the Exchanging Shareholders with an estimated fair value of $5,697,000. The Exchange PFWs do not expire and are exercisable to purchase an aggregate of 3,000,000 shares of the Company’s outstanding common stock at an exercise price of $0.001 per share. As required pursuant to the Exchange Agreement, the Company filed a registration statement in August 2024 to register the shares issuable upon the exercise of the Exchange PFWs.
The Exchange PFWs originally required approval by the Company’s shareholders if the exercise of the Exchange PFWs resulted in aggregate beneficial ownership by the holders in excess of 19.99%. Even though the Exchange PFWs only entitled the holders to purchase 7% of the Company’s outstanding shares of common stock, the requirement to obtain shareholder approval for ownership in excess of 19.99% resulted in the treatment of the exchange PFWs as a warrant derivative liability of $5.7 million as of the issuance date. The fair value of this warrant derivative liability increased by approximately $2.9 million, for a total of approximately $8.5 million as of May 13, 2024 when the Exchange PFWs were amended to permit equity classification. Accordingly, the derivative liability was reclassified to shareholders’ equity on May 13, 2024.
Jefferies Open Market Sales Agreement
On November 14, 2023, the Company and Jefferies LLC (the “Agent”) entered into an open market sales agreement (the “Sales Agreement”) 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 is acting as sales agent and is 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 Sales Agreement will terminate when all of the Placement Shares have been sold, or earlier upon the election of either the Company or the Agent.
The Company has no obligation to sell any of the Placement Shares under the Sales Agreement. The Company intends to use the net proceeds, if any, from amounts sold under the Sales Agreement for general corporate purposes, including working capital. Under the terms of the Sales Agreement, 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 three months ended September 30, 2024, the Company didnot elect to sell any shares of its common stock pursuant to the Sales Agreement. Accordingly, the maximum amount remaining for sale under the Sales Agreement amounts to $50.0 million as of September 30, 2024.
NOTE 8 — SHARE-BASED COMPENSATION AND WARRANTS
Stock Option Plans
Presented below is a summary of the number of shares outstanding, authorized, and available for future grants under the Company’s stock option plans and an inducement grant not associated with a stock option plan as of September 30, 2024 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | Number of Shares as of September 30, 2024 | |||||
| Description · Authorized · Outstanding · Available | ||||||
| 2015 Plan | 17 | 17 | — | |||
| 2016 Plan | 123 | 123 | — | |||
| 2019 Plan | 200 | 200 | — | |||
| 2021 Plan | | 10,580 | | 10,160 | | 420 |
| Inducement Grant | | 275 | | 275 | | — |
| Total | 11,195 | 10,775 | 420 | |||
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. There have beenno offering periods under the 2022 ESPP through September 30, 2024.
Stock Options Outstanding
For the three months ended September 30, 2024, the following table sets forth a summary of the combined activity under the Company’s stock option plans and an inducement grant not associated with a stock option plan (shares in thousands):
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · Shares · Price (1) · Term (2) | |||||||
| Outstanding, June 30, 2024 | 10,891 | | $3.82 | | 8.1 | ||
| Grants to employees | | 240 | | | 4.73 | | |
| Exercises | | (38) | (3) | | 2.44 | | |
| Forfeited | | (318) | | | 2.61 | | |
| Outstanding, September 30, 2024 | 10,775 | (4) | 3.88 | 7.7 | |||
| Vested, September 30, 2024 | 5,525 | (5) | 5.07 | 7.2 | |||
| (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. |
| (3) | The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised during the three months ended September 30, 2024, was $0.1 million. |
| (4) | As of September 30, 2024, the intrinsic value of outstanding options was approximately $19.2 million. |
| (5) | As of September 30, 2024, the aggregate intrinsic value of vested stock options was approximately $7.5 million. |
For the three months ended September 30, 2024, the aggregate fair value of stock options granted for approximately 0.2 million shares of common stock amounted to $0.8 million or approximately $3.45 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 three months ended September 30, 2024, the fair value of stock options was estimated on the respective dates of grant, with the following weighted-average assumptions:
| | | | | |
|---|---|---|---|---|
| Market price of common stock on grant date | | $4.73 | | |
| Expected volatility | | 84% | ||
| Risk free interest rate | | 3.7% | ||
| Expected term (years) | | 6.1 | | |
| Dividend yield | | 0% |
Share-based compensation expense for the three months ended September 30, 2024 and 2023 is included under the following captions in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · 2024 · 2023 · | |||||
| Research and development | | $712 | | $840 | |
| General and administrative | | 688 | | 1,009 | |
| Total | | $1,400 | | $1,849 | |
Unrecognized share-based compensation expense is approximately $10.4 million as of September 30, 2024. This amount is expected to be recognized over a weighted average period of 1.8 years.
Pre-Funded Warrants
PFWs are outstanding for a total of 14.4 million shares as of September 30, 2024. Please refer to Note 7 for additional information about outstanding PFWs.
Legacy 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 ofseven years, may be exercised on a cash or cashless basis at the election of the holders, and the 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 in conjunction with various debt and equity financings and for services. As of September 30, 2024, all of the warrants were vested. The Participating Warrants and other warrants are collectively referred to as the “Legacy Warrants.”
For the three months ended September 30, 2024, no Legacy Warrants were granted or exercised. The following table sets forth a summary of all Legacy Warrants for the three months ended September 30, 2024 (shares in thousands):
| · · · · · · · | |||
|---|---|---|---|
| | Shares | Price (1) | Term (2) |
| Outstanding, June 30, 2024 | 861 | $20.28 | 3.2 |
| Expirations | (10) | 52.00 | |
| Outstanding, September 30, 2024 | 851 | 19.90 | 3.0 |
| (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 9 — 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.
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. 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. As of September 30, 2024, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the Company’s results of operations. Legal fees are expensed as incurred.
NOTE 10 — 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 ersodetug 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 2024 Private Placement
Handok was an investor in the 2024 Private Placement discussed in Note 7 for which the Company issued 1,250,000 shares of common stock at a purchase price of $4.00 resulting in gross proceeds of $5.0 million.
NOTE 11 — 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 income 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 months ended September 30, 2024 and 2023, the Company did not recognize any income tax benefit due to a full valuation allowance on its deferred income 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 months ended September 30, 2024 and 2023.
NOTE 12 — 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 PFWs during periods when the PFWs are accounted for as equity instruments. Common shares associated with PFWs that are accounted for as equity instruments 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 for basic and diluted net loss per share is computed as follows for the three months ended September 30, 2024 and 2023 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2024 · 2023 | ||||||
| Common Stock | | | 55,167 | | | 36,827 |
| 2021 PFWs | | | 123 | | | 1,661 |
| 2022 PFWs | | | 8,147 | | | 12,921 |
| Exchange PFWs | | | 2,549 | | | — |
| 2024 PFWs | | | 3,750 | | | — |
| Total | | | 69,736 | | | 51,409 |
For the three months ended September 30, 2024 and 2023, basic and diluted net loss per share were the same since all other common stock equivalents were anti-dilutive.
As of September 30, 2024 and 2023, 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):
| | | | | |
|---|---|---|---|---|
| | | 2024 | | 2023 |
| Stock options | | 10,775 | | 9,109 |
| Legacy warrants | | 851 | | 888 |
| Total | | 11,626 | | 9,997 |
NOTE 13 — 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 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 as of September 30, 2024 and June 30, 2024 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · | ||||||||||||
| · · Fair Value Measurement of Assets as of September 30, 2024 | ||||||||||||
| · · Total · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $5,894 | | $5,894 | | $— | | $— | ||||
| Marketable debt securities: | | | | | | | | | | | | |
| Corporate commercial paper | | | 31,522 | | | — | | | 31,522 | | | — |
| U.S. Government agencies | | | 5,277 | | | — | | | 5,277 | | | — |
| U.S. Government treasuries | | | 13,664 | | | — | | | 13,664 | | | — |
| Corporate notes and bonds | | | 56,890 | | | — | | | 56,890 | | | — |
| Total | | $113,247 | | $5,894 | | $107,353 | | $— | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurement of Assets as of June 30, 2024 | ||||||||||||
| · · Total · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $61,249 | | $61,249 | | $— | | $— | ||||
| Marketable debt securities: | | | | | | | | | | | | |
| Corporate commercial paper | | | 20,929 | | | — | | | 20,929 | | | — |
| U.S. Government agencies | | | 1,997 | | | — | | | 1,997 | | | — |
| U.S. Government treasuries | | | 2,720 | | | — | | | 2,720 | | | — |
| Corporate notes and bonds | | | 30,832 | | | — | | | 30,832 | | | — |
| Asset-backed securities | | | 263 | | | — | | | 263 | | | — |
| Total | | $117,990 | | $61,249 | | $56,741 | | $— | ||||
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 September 30, 2024 and June 30, 2024.
The Company’s embedded derivative liability discussed in Note 6 is classified under Level 3 of the fair value hierarchy and is 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 6 using a discount rate equal to the effective interest rate under the Loan Agreement.
The following table sets forth changes in the fair value of the Company’s embedded derivative liability measured at fair value liability for the three months ended September 30, 2024 and 2023 (in thousands):
| | | | | | |
|---|---|---|---|---|---|
| · 2024 · · 2023 | |||||
| Fair value, beginning of period | $468 | | $412 | ||
| Changes in fair value | | 15 | | | 14 |
| Fair value, end of period | $483 | | $426 | ||
Except for the embedded derivative liability, the Company did not have any other liabilities measured at fair value on a recurring basis as of September 30, 2024 and June 30, 2024.
Due to the relatively short maturity of the respective instruments, the fair value of cash, accounts payable, and accrued liabilities approximated their carrying values as of September 30, 2024 and June 30, 2024.
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 three months ended September 30, 2024 and 2023, 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, cash equivalents and investments in marketable debt securities. The Company maintains cash in demand deposit accounts at a high-quality financial institution. As of and for the three months ended September 30, 2024 and 2023, cash deposits have exceeded the amount of insurance provided on such deposits by the Federal Deposit Insurance Corporation.
As of September 30, 2024, the Company has an aggregate of $41.3 million invested in the debt securities of issuers in the banking and financial services industries. 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. To date, the Company has not experienced any credit losses or impairments of marketable debt securities due to credit rating agency downgrades.
NOTE 14 — SUBSEQUENT EVENTS
Exchange PFW Warrant Exercises
In October 2024, holders of Exchange PFWs provided notice of cashless exercises of the remaining 2,389,596 Exchange PFWs outstanding, which resulted in the issuance of 2,389,111 shares of common stock.
2022 PFW Warrant Exercise
On November 7, 2024, a holder of certain 2022 PFWs provided notice of cashless exercises of 2,526,318 Class B PFWs, which will result in the issuance of 2,525,883 shares of common stock in November 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.