Rezolute, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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Sep 30, 2026 · Filed Nov 5, 2026
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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 developing therapies that treat refractory and debilitating hypoglycemia associated with various forms of hyperinsulinism (“HI”). The Company believes that its primary clinical asset, ersodetug, is a potential treatment for refractory hypoglycemia caused by multiple forms of hyperinsulinism, including congenital HI and tumor HI. The Company is fully enrolled in a Phase 3 clinical trial for a tumor HI indication (“upLIFT”) and topline data is expected in mid-December 2026. As announced on October 5, 2026, following a preliminary review of detailed data from the Phase 3 clinical trial of ersodetug for the treatment of hypoglycemia due to congenital HI (“sunRIZE”), the FDA recommended a pre-biologics license application meeting with the Company as a precursor to submitting a biologics license application (“BLA”). The Company expects to request a pre-BLA meeting with the Agency to take place during the first half of calendar year 2027.
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”), and the rules and regulations of the SEC for interim financial information, including the instructions to Form 10-Q and Article 8 of Regulation S-X.
The condensed consolidated balance sheet as of June 30, 2026, has been derived from the Company’s audited consolidated financial statements. The unaudited interim financial statements should be read in conjunction with the 2026 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, 2026.
The Company’s Chief Executive Officer also serves as the Company’s chief operating decision maker (“CODM”) for purposes of allocating resources and assessing performance based on financial information of the Company. Since its inception, the Company has determined that its activities as a clinical stage biopharmaceutical company are classified as a single reportable operating segment.
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, the interim financial statements 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, 2026, 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, 2027.
Consolidation
The Company hastwo wholly owned subsidiaries consisting of Rezolute (Bio) Ireland Limited, and Rezolute Bio UK, Ltd. The accompanying unaudited condensed 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 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 2026 Form 10-K.
Recently Adopted Accounting Standard
In September 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-07,Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606)(“ASU 2025-07”). This update provides a derivative scope refinement and scope clarification for share-based noncash consideration from a customer in a revenue contract. Entities may apply the amendments prospectively to new contracts or retrospectively with a cumulative-effect adjustment. ASU 2025-07 is effective for annual periods beginning after December 15, 2026, with early adoption permitted. The Company early adopted the guidance in ASU 2025-07 effective July 1, 2026, and applied the guidance on a prospective basis. The adoption of ASU 2025-07 did not have a material impact on the unaudited condensed consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03,Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 is intended to enhance disclosures by requiring public entities to disclose specified information about certain costs and expenses. The Company is required to adopt ASU 2024-03 in its annual financial statements for the fiscal year ending June 30, 2028, and for interim periods thereafter. The Company does not expect the adoption of ASU 2024-03 will have a material impact on its consolidated financial statements as the ASU only requires more detailed disclosures in the footnotes to the Company’s consolidated financial statements.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not currently expected to have a material impact on the Company’s consolidated financial statements upon adoption.
Note 2 — Liquidity
The Company is in the clinical stage and has not yet generated any revenues. For the three months ended September 30, 2026, the Company incurred a net loss of $18.5 million and net cash used in operating activities amounted to $18.8 million. For the fiscal year ended June 30, 2026, the Company incurred a net loss of $77.6 million and net cash used in operating activities amounted to $64.6 million. As of September 30, 2026, the Company had an accumulated deficit of $499.9 million, and the Company’s capital resources consist of cash and cash equivalents of $8.2 million and short-term investments in marketable debt securities of $81.8 million.
As of September 30, 2026, the Company has total liabilities of $10.1 million, including current liabilities of $9.5 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 Ersodetug License Agreement (as defined below), a $25.0 million milestone payment will be due upon regulatory approval of ersodetug by any regulatory authority. Due to uncertainties in the timing associated with regulatory approvals, the timing of the commitment to pay the $25.0 million for regulatory approval of ersodetug remains unknown.
Management believes the Company’s cash and cash equivalents and investments in marketable debt securities will be adequate to meet the Company’s contractual obligations and fund operations for at least 12 months from the issuance date of the unaudited condensed consolidated financial statements as of September 30, 2026.
Note 3 — Investments in Marketable Debt Securities
Investments in marketable debt securities are accounted for as available-for-sale investments at fair value. 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, 2026, investments in marketable debt securities with an aggregate fair value of $81.8 million are scheduled to mature during the 12-month period ending September 30, 2027. As of September 30, 2026, the Company didnot hold any long-term investments in marketable debt securities.
During the three months ended September 30, 2026, marketable debt securities for $35.9 million matured and approximately $20.1 million was invested in additional marketable debt securities. The Company did not sell any marketable debt securities prior to the scheduled maturity dates for the three months ended September 30, 2026.
Accrued interest receivable on all marketable debt securities amounted to $0.3 million and $0.5 million as of September 30, 2026 and June 30, 2026, respectively. Accrued interest receivable is included in other current assets in the accompanying unaudited condensed consolidated balance sheets.
For the three months ended September 30, 2026, the Company didnot recognize any allowance for credit losses or 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, 2026 and June 30, 2026 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · September 30, 2026 | ||||||||||||
| · · · · · Gross Unrealized · · · | ||||||||||||
| · · Amortized Cost · · Gains · · Losses · · Fair Value | ||||||||||||
| Corporate commercial paper | | $43,077 | | $— | | $(94) | | $42,983 | ||||
| Corporate notes and bonds | | | 36,691 | | | — | | | (76) | | | 36,615 |
| U.S. Treasury obligations | | | 2,253 | | | — | | | (2) | | | 2,251 |
| Total | | $82,021 | | $— | | $(172) | | $81,849 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · June 30, 2026 | ||||||||||||
| · · · · · Gross Unrealized · · · | ||||||||||||
| · · Amortized Cost · · Gains · · Losses · · Fair Value | ||||||||||||
| Corporate commercial paper | | $41,935 | | $— | | $(57) | | $41,878 | ||||
| Corporate notes and bonds | | | 51,362 | | | — | | | (60) | | | 51,302 |
| U.S. Treasury obligations | | | 4,008 | | | — | | | (2) | | | 4,006 |
| Total | | $97,305 | | $— | | $(119) | | $97,186 | ||||
Note 4 — Operating Leases
The carrying value of all right-of-use assets and operating lease liabilities is as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · June 30, | ||||||
| · · 2026 · · 2026 | ||||||
| Right-of-use assets | | $616 | | $769 | ||
| | | | | | | |
| Operating lease liabilities: | | | | | ||
| Current | | $643 | | $658 | ||
| Long-term | | 111 | | 276 | ||
| Total | | $754 | | $934 | ||
For the three months ended September 30, 2026 and 2025, operating lease expense is included under the following captions in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Research and development | | $118 | | $120 |
| General and administrative | | 49 | | 47 |
| Total | | $167 | | $167 |
As of September 30, 2026, the weighted average remaining lease term under operating leases was 1.0 years, and the weighted average discount rate used to determine the operating lease liabilities was 7.0%. Future cash payments under all operating lease agreements as of September 30, 2026 are as follows (in thousands):
| | | | |
|---|---|---|---|
| Fiscal year ending June 30, | | | |
| 2027 | | $555 | |
| 2028 | | | 224 |
| Total lease payments | | | 779 |
| Less imputed interest | | (25) | |
| Present value of operating lease liabilities | | $754 |
Note 5 — License Agreements
Ersodetug License Agreement
In December 2017, the Company entered into a license agreement that has been subsequently amended (“Ersodetug License Agreement”) with a wholly-owned subsidiary of XOMA Corporation (“XOMA”), pursuant to which XOMA granted an exclusive global license to the Company to develop and commercialize ersodetug for all indications. On July 14, 2026, XOMA was acquired by Ligand Pharmaceuticals Incorporated (“Ligand”).
To date the Company has paid a total of $12.0 million in milestone payments pursuant to the Ersodetug License Agreement. The most recent milestone payment of $5.0 million became due in May 2025 upon dosing of the last patient in the Company’s Phase 3 clinical trial for ersodetug and was paid in June 2025. The next milestone payment of $25.0 million will be due upon regulatory approval for ersodetug by any regulatory authority. After the final regulatory milestone, the Company will be required, upon the future commercialization of ersodetug, to pay royalties to Ligand based on the net sales of the related products and additional milestone payments 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 Ersodetug License Agreement to date. The Company records a liability for milestone payments under license agreements in the period that the milestone event is achieved.
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 initially focused on the development of RZ402 as a therapy for diabetic macular edema (“DME”). Following the completion of a Phase 2 clinical study for RZ402, the Company decided to pause the program to focus its resources on ersodetug. The Company is currently exploring the use of the PKI Portfolio to develop therapies for different indications. To date the Company has paid a total of $4.0 million in milestone payments to ActiveSite. The most recent milestone payment of $3.0 million was 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. Upon the achievement of certain clinical and regulatory events and various sales-based milestones and alternative indication regulatory approvals under the ActiveSite License Agreement the Company will be required to make up to $42.5 million in additional milestone payments to ActiveSite. The Company is also required to pay royalties equal to 2.0% of any net 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, but the Company elected to repay the entire amount and the Loan Agreement was terminated 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, 2026 and June 30, 2026. Exit Events include, but are not limited to, sales of substantially all assets, certain mergers, change of control transactions, and certain issuances of common stock whereby more than 35% of the Company’s shares are issued to parties other than its existing investors in a single transaction or series of related transactions. 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 April 2025, the Company issued fully vested pre-funded warrants (“PFWs”). As of September 30, 2026, 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 (“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.
For the three months ended September 30, 2026, no PFWs were issued or exercised. As of September 30, 2026 and June 30, 2026, the Company had an aggregate of 8,174,438 PFWs that were outstanding as follows:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| | 2021 | | 2022 | | 2024 | | 2025 | | |
| | PFWs | | PFWs | | PFWs | | PFWs | | Total |
| PFWs outstanding | 123,000 | (1) | 3,421,053 | (2) | 1,875,000 | (3) | 2,755,385 | (4) | 8,174,438 |
| (1) | Issued in connection with an underwritten offering in October 2021 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) | Issued in connection with a registered direct offering in May 2022 at an issuance price of $3.799 per warrant (the “2022 PFWs”). The exercise price of the 2022 PFWs is $0.001 per share. |
| (3) | Issued in connection with an underwritten offering in June 2024 at an issuance price of $3.999 a share (the “2024 PFWs”). The exercise price of the 2024 PFWs is $0.001 per share. |
| (4) | Issued in connection with an underwritten offering in April 2025 at an issuance price of $3.249 a share (the “2025 PFWs”). The exercise price of the 2025 PFWs is $0.001 per share. |
Note 8 — Share-Based Compensation and Warrants
Equity Incentive Plans
Presented below is a summary of the number of shares authorized, outstanding, and available for future grants under the Company’s equity incentive plans as of September 30, 2026:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Number of Shares | ||||||
| Description | | Authorized | | Outstanding | | Available |
| 2015 Plan | 14,000 | | 14,000 | — | ||
| 2016 Plan | 115,200 | | 115,200 | — | ||
| 2019 Plan | 200,000 | 200,000 | — | |||
| 2021 Plan | | 19,877,201 | | 13,454,574 | | 6,422,627 |
| Inducement Awards | | 1,500,000 | | 705,000 | | 795,000 |
| Total | 21,706,401 | 14,488,774 | (1) | 7,217,627 | ||
| (1) | Consists of approximately 12.5 million shares outstanding under stock option agreements and 2.0 million shares under restricted stock units. |
The Company currently hasone active stock option plan approved by shareholders which is the 2021 Plan. The 2021 Plan terminates on March 31, 2030. Pursuant to the 2021 Plan, no awards may be granted under the three legacy stock option plans shown in the table above, but all outstanding awards previously granted under those plans shall remain outstanding and subject to the terms of the respective plans. Stock options outstanding under the plans presented above expire pursuant to their contractual provisions on various dates through 2036.
In addition, inducement awards are allowed for grants of options pursuant to Nasdaq Listing Rule 5635(c)(4) whereby the underlying shares are not authorized under any of the Company’s stock option plans. Through September 30, 2026, the Board of Directors has authorized a total of 1,500,000 shares for inducement awards. The Board of Directors has discretion to issue 795,000 shares for future inducement awards as of September 30, 2026.
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 500,000 shares for purchases. There have beenno offering periods under the 2022 ESPP through September 30, 2026.
Stock Options Outstanding
For the three months ended September 30, 2026, the following table summarizes the combined stock option activity under the Company’s equity incentive plans and Inducement Awards:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Shares · · Price (1) · · Term (2) | |||||||
| Outstanding, beginning of period | 12,468,431 | | $4.73 | 6.9 | |||
| Granted | | 210,000 | | | 4.59 | | |
| Exercised | | (174,846) | (3) | | 3.01 | | |
| Expired | | (2,055) | | | 10.16 | | |
| Forfeited | | (39,336) | | | 5.69 | | |
| Outstanding, end of period | 12,462,194 | (4) | 4.74 | 6.7 | |||
| Vested, end of period | 9,484,599 | (5) | 4.42 | 6.1 | |||
| (1) | Represents the weighted average exercise price per share. |
| (2) | Represents the weighted average remaining contractual term 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, 2026, was $0.3 million. |
| (4) | As of September 30, 2026, the intrinsic value of outstanding stock options was approximately $9.6 million. |
| (5) | As of September 30, 2026, the intrinsic value of vested stock options was approximately $8.3 million. |
For the three months ended September 30, 2026, the aggregate fair value of stock options granted for approximately 0.2 million shares of common stock amounted to $0.7 million or approximately $3.52 per share as of the grant dates. Fair value of stock options was computed using the BSM option-pricing model and will result in the recognition of compensation expense ratably over the expected vesting period of the stock options. Unrecognized share-based compensation expense related to outstanding stock options is approximately $11.6 million as of September 30, 2026. This amount is expected to be recognized over a weighted average period of 2.1 years.
For the three months ended September 30, 2026, 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 | | $4.59 | | |
| Expected volatility | | | 90% | |
| Risk free interest rate | | 4.6% | ||
| Expected term (years) | | 6.1 | | |
| Dividend yield | | 0% |
Restricted Stock Units (“RSUs”)
For the three months ended September 30, 2026, the following table summarizes the combined RSU activity under the Company’s 2021 Plan:
| | | | | | |
|---|---|---|---|---|---|
| · · Shares · · Price (1) | |||||
| Unvested, beginning of period | 2,230,335 | | $8.46 | ||
| Granted | | — | | | — |
| Vested | | (141,505) | (2) | | 4.52 |
| Forfeited | | (62,250) | | | 7.16 |
| Unvested, end of period | 2,026,580 | | | 8.78 | |
| (1) | Represents the weighted average fair value per share based on the closing market price of the Company’s common stock on the grant date of the respective RSUs. |
| (2) | Based on the closing market price of the Company’s common stock on the respective vesting dates, the aggregate fair value for the RSUs that vested during the three months ended September 30, 2026, amounts to $0.7 million or approximately $4.87 per share. |
There wereno grants of RSUs during the three months ended September 30, 2026. RSUs vest over a period ofone tofour years. Fair value is based on the closing market price on the date of grant and will result in the recognition of compensation cost on a straight-line basis over the vesting period of the RSUs. Unrecognized share-based compensation expense related to RSUs is approximately $12.3 million as of September 30, 2026. This amount is expected to be recognized over a weighted average period of 1.9 years.
Share-Based Compensation Expense
Share-based compensation expense for the three months ended September 30, 2026 and 2025 is included under the following captions in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Research and development | | $1,468 | | $1,167 |
| General and administrative | | 1,806 | | 1,364 |
| Total | | $3,274 | | $2,531 |
The aggregate unrecognized share-based compensation expense related to stock options and RSUs was approximately $23.9 million as of September 30, 2026. This amount is expected to be recognized over a weighted average period of 2.0 years.
Pre-Funded Warrants
PFWs are outstanding for a total of approximately 8.2 million shares as of September 30, 2026. 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 820,001 shares of common stock. These 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, 2026, 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, 2026, no Legacy Warrants were granted, expired orexercised. As of September 30, 2026, Legacy Warrants were outstanding for an aggregate of 849,782 shares with a weighted average exercise price of $19.86 per share. The weighted average remaining contractual term for the Legacy Warrants was 1.0 year as of September 30, 2026.
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 Ligand 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 or a potential range of loss is probable and reasonably estimable under ASC 450,Contingencies. As of September 30, 2026, there have been no pending or threatened lawsuits against the Company 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, Inc. (“Handok”), whose CEO serves on the Company’s board of directors, 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 the PKI Portfolio. 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 regulatory approval 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.
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, 2026 and 2025, 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, 2026 and 2025.
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. 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 because 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 for the three months ended September 30, 2026 and 2025 consists of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||
| Common Stock | | | 96,603,073 | | | 89,625,732 |
| 2021 PFWs | | | 123,000 | | | 123,000 |
| 2022 PFWs | | | 3,421,053 | | | 4,113,943 |
| 2024 PFWs | | | 1,875,000 | | | 3,198,883 |
| 2025 PFWs | | | 2,755,385 | | | 6,361,089 |
| Total | | | 104,777,511 | | | 103,422,647 |
For the three months ended September 30, 2026 and 2025, basic and diluted net loss per share are the same since all other common stock equivalents were anti-dilutive. As of September 30, 2026 and 2025, the following potential common stock equivalents were excluded from the computation of diluted net loss per share since the impact of inclusion was anti-dilutive:
| | | | | |
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Stock options | | 12,462,194 | | 13,395,587 |
| RSUs | | 2,026,580 | | 1,081,500 |
| Legacy Warrants | | 849,782 | | 850,262 |
| Total | | 15,338,556 | | 15,327,349 |
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 tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the fair value hierarchy classification as of September 30, 2026 and June 30, 2026 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · | ||||||||||||
| · · Fair Value Measurement of Assets as of September 30, 2026 | ||||||||||||
| · · Total · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $4,413 | | $4,413 | | $— | | $— | ||||
| Marketable debt securities: | | | | | | | | | | | | |
| Corporate commercial paper | | | 42,983 | | | — | | | 42,983 | | | — |
| Corporate notes and bonds | | | 36,615 | | | — | | | 36,615 | | | — |
| U.S. Treasury securities | | | 2,251 | | | — | | | 2,251 | | | — |
| Total | | $86,262 | | $4,413 | | $81,849 | | $— | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurement of Assets as of June 30, 2026 | ||||||||||||
| · · Total · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $6,102 | | $6,102 | | $— | | $— | ||||
| Marketable debt securities: | | | | | | | | | | | | |
| Corporate commercial paper | | | 41,878 | | | — | | | 41,878 | | | — |
| Corporate notes and bonds | | | 51,302 | | | — | | | 51,302 | | | — |
| U.S. Treasury securities | | | 4,006 | | | — | | | 4,006 | | | — |
| Total | | $103,288 | | $6,102 | | $97,186 | | $— | ||||
Marketable debt securities classified as Level 2 within the valuation hierarchy generally consist of corporate bonds, commercial paper, and U.S. government agency securities. 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 tables above, the Company did not have any other assets measured at fair value on a recurring basis as of September 30, 2026 and June 30, 2026.
The 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 historical effective interest rate under the Loan Agreement.
The following table sets forth changes in the fair value of the embedded derivative liability for which fair value was determined on a recurring basis for the three months ended September 30, 2026 and 2025 (in thousands):
| | | | | | |
|---|---|---|---|---|---|
| · 2026 · · 2025 | |||||
| Fair value, beginning of period | $468 | | $468 | ||
| Changes in fair value | | 20 | | | 15 |
| Fair value, end of period | $488 | | $483 | ||
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, 2026 and June 30, 2026.
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, 2026 and June 30, 2026.
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, 2026 and 2025, 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, 2026 and 2025, cash deposits have exceeded the amount of insurance provided on such deposits by the Federal Deposit Insurance Corporation.
As of September 30, 2026, the Company had an aggregate of $49.0 million invested in marketable 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 — Segment Disclosures
The Company has determined that it operates as asingle reportable segment which includes all of its activities as a clinical stage biopharmaceutical company. The CODM uses consolidated net loss as reported in the unaudited condensed consolidated statements of operations and comprehensive loss to assess performance, analyze budget to actual results, forecast future operating results and cash requirements, and allocate resources for its single reportable segment. The significant segment expenses regularly reviewed by the CODM consist of clinical and manufacturing costs of ersodetug, personnel expenses, and other segment expenses. The measure of the operating segment assets is reported on the unaudited condensed consolidated balance sheets as total assets and all of the Company's tangible assets are located in the United States.
The following table presents consolidated net loss summarized by the significant segment expenses regularly reviewed by the CODM for the three months ended September 30, 2026, and 2025 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||
| Research and development: · · · · · | ||||||
| Ersodetug | | $5,519 | | $5,610 | ||
| Compensation and benefits | | | 5,573 | | | 5,588 |
| Other research and development segment expenses (1) | | | 1,715 | | | 1,951 |
| Total research and development | | 12,807 | | | 13,149 | |
| General and administrative: | | | | | | |
| Compensation and benefits | | | 3,692 | | | 3,350 |
| Other general and administrative segment expenses (2) | | | 2,886 | | | 3,318 |
| Total general and administrative | | 6,578 | | | 6,668 | |
| Operating loss | | | (19,385) | | | (19,817) |
| Total non-operating income, net | | | 898 | | | 1,667 |
| Net loss | | $(18,487) | | $(18,150) | ||
| (1) | Other research and development segment expenses primarily include quality, regulatory, and other pipeline development costs; employee travel and other employee expenses; and other facility and information technology costs. |
| (2) | Other general and administrative segment expenses primarily include consulting expenses related to business development and market planning activities, insurance expense, public company costs, employee travel and expense, and other facility and information technology costs. |
Note 15 — Subsequent Events
Consulting Agreement
On October 1, 2026, the Company entered into a consulting agreement under which it will receive professional services on an hourly basis and pay a one-time success fee of $1.0 million (the “Success Fee”) upon regulatory approval for ersodetug for either congenital HI or tumor HI, provided that no additional clinical study is required for the approved indication. The Company would also become obligated to pay the Success Fee upon entering into a definitive agreement providing for a merger, acquisition, change of control, sale of all or substantially all of the Company’s assets, or other similar strategic transaction before regulatory approval of ersodetug. Payment of the Success Fee is due upon, and is a condition to, the closing of such transactions. The Company records a liability for contingent payments in the period that the event becomes probable.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.