Rezolute, Inc.
For the period ended Jun 30, 2026. Filed Sep 24, 2026.
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FY2026 · Filed Sep 24, 2026
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Notes to consolidated financial statements
NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of Operations
Rezolute, Inc. (the “Company”) is a 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 currently enrolling in a Phase 3 clinical trial for a tumor HI indication (“upLIFT”). In December 2025, the Company reported that its Phase 3 clinical trial in congenital HI (“sunRIZE”) did not meet its primary endpoint or key secondary endpoint. The Company met with the Food and Drug Administration (“FDA” or the “Agency”) in March 2026 to discuss the summary results from sunRIZE. As a next step for the program, FDA encouraged the Company to submit comprehensive analysis datasets and summary outcomes for the Agency’s independent evaluation. Following that review, the Company believes that a determination may be made whether there is sufficient evidence to support the submission of a marketing application for sunRIZE or if additional information and/or clinical studies are required, which could have an impact on the Company’s operating plans and cash resources. In September 2026, the FDA informed the Company that it is still reviewing the submission for purposes of evaluating a potential regulatory path forward for ersodetug in congenital HI. The Company expects to provide an update on the program in the second half of calendar year 2026.
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.
Basis of Presentation
The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Comprehensive income (loss) is defined as net income (loss) plus other comprehensive income (loss). Other comprehensive income (loss) is comprised of revenues, expenses, gains, and losses that under GAAP are reported as separate components of shareholders’ equity instead of net income (loss). For the fiscal years ended June 30, 2026 and 2025, the components of comprehensive loss consisted of the Company’s net loss and unrealized gains (losses) on investments in marketable debt securities.
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.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts in the consolidated financial statements and the accompanying notes. The Company bases its estimates and assumptions on current facts, historical experience, and various other factors that it believes are reasonable under the circumstances, to determine the carrying values of assets and liabilities that are not readily apparent from other sources. The Company’s significant accounting estimates include, but are not necessarily limited to, fair value of share-based compensation, management’s assessment of going concern, and estimates related to clinical trial accrued liabilities. Actual results could differ from those estimates.
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Risks and Uncertainties
The Company's operations may be subject to significant risks and uncertainties including financial, operational, regulatory and other risks associated with a clinical stage company, including the potential risk of business failure discussed in Note 2.
Cash and Cash Equivalents
All highly liquid investments purchased with an original maturity of three months or less that are freely available for the Company’s immediate and general business use are classified as cash and cash equivalents. Cash and cash equivalents consist primarily of demand deposits with financial institutions, money market funds, U.S. treasuries and corporate commercial paper purchased with a maturity of three months or less.
Investments in Marketable Debt Securities
Under the investment policy approved by the Company’s Board of Directors, eligible investments in fixed income debt securities must be denominated and payable in U.S. dollars, including eligible corporate bonds, corporate commercial paper, U.S. government obligations, and money market funds. This investment policy only permits investments in the debt securities of issuers that meet stringent credit quality ratings on the date of the investment. The investment policy also places restrictions on the length of maturities and concentrations by type and issuer. The Company only invests in issuers that management believes are of high credit quality. However, all issuers are exposed to credit risk that could ultimately result in a default. The Company classifies investments in marketable debt securities that mature in less than one year as short-term assets. For investments that mature in more than one year, the investments are classified as long-term assets unless management intends to liquidate the investments to fund current operations before the scheduled maturity dates.
The Company accounts for all of its investments in marketable debt securities as available-for-sale securities whereby they are recorded in the consolidated balance sheet at fair value. Interest income is recognized in the consolidated statement of operations, consisting of accrued interest earned based on the coupon rate of the security, plus the impact of accreting discounts and amortizing premiums to maturity using the straight-line method which approximates the interest method. Unrealized gains and losses due to subsequent changes in fair value of the investments are reported in shareholders’ equity as a component of accumulated other comprehensive income (loss). The Company reviews the components of its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below amortized cost have resulted from a credit-related loss or other factors. If declines in fair value below amortized costs are due to the deterioration of an issuer’s credit quality, the Company is required to record an allowance for credit losses related to such investments with a corresponding loss recognized in the consolidated statements of operations. Allowances for credit losses may be reversed in subsequent periods if conditions improve and credit-related losses are no longer expected. For declines in fair value that are solely due to changes in interest rates, impairment is not recognized if the Company has the ability and intent to hold the investment until maturity.
Prepaid Expenses and Other
Prepaid expenses and other includes nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities. These advance payments are deferred and recognized as expenses in the period that the related goods are delivered, or services are performed.
Leases
The Company determines if an arrangement includes a lease as of the date an agreement is entered into. Operating leases are included in right-of-use (“ROU”) assets and operating lease liabilities in the Company's consolidated balance sheets. ROU assets and operating lease liabilities are initially recognized based on the present value of the future minimum lease payments at the commencement date of the lease. The Company generally uses its incremental borrowing rate based on the information available at the lease commencement date to determine the discount rate used to compute the present value
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of future payments. The Company's leases may include options to extend or terminate the lease; these options are included in the calculation of ROU assets and operating lease liabilities when it is reasonably certain that the Company will exercise the options. Lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to apply the recognition requirements for short-term leases. For lease agreements with lease and non-lease components, the Company generally accounts for them separately.
Property and Equipment
Property and equipment consist solely of office furniture and equipment that is recorded at cost. Depreciation expense is calculated using the straight-line method over the estimated useful lives of the assets which range from 3 to 5 years. Maintenance and repairs are expensed as incurred.
Research and Development Costs
Research and development costs are expensed as incurred. Intangible assets for in-licensing costs incurred under license agreements with third parties are charged to expense, unless the licensing rights have separate economic value in alternative future research and development projects or otherwise.
Clinical Trial Accruals
Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with clinical research organizations and clinical trial sites. The Company determines the estimates through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
Share-Based Compensation
The Company measures the fair value of employee and director services received in exchange for grants of stock options and other equity awards, based on the fair value of the award as of the grant date. The Company computes the fair value of stock options using the Black-Scholes-Merton (“BSM”) option pricing model and recognizes the value of the equity awards over the period that services are provided to earn the award, usually the vesting period. For awards granted which contain a graded vesting schedule, and the only condition for vesting is a service condition, compensation cost is recognized as an expense on a straight-line basis over the requisite service period as if the award was, in substance, a single award. Fair value of restricted stock units (“RSUs”) is based on the closing market price on the date of grant whereby compensation cost is recognized on a straight-line basis over the vesting period of the RSUs. The Company recognizes the impact of forfeitures in the period that the forfeiture occurs, rather than estimating the number of awards that are not expected to vest in accounting for share-based compensation.
Embedded Derivatives
When the Company enters into a financial instrument such as a debt or equity agreement (the “Host Contract”), the Company assesses whether the economic characteristics of any embedded features would meet the definition of a derivative instrument, and whether such features are considered clearly and closely related to the primary economic characteristics of the Host Contract. When it is determined that (i) an embedded feature possesses economic characteristics that are not clearly and closely related to the primary economic characteristics of the Host Contract, and (ii) a separate, stand-alone instrument with the same terms would meet the definition of a financial derivative instrument and cannot be classified in shareholders’ equity, then the embedded feature is bifurcated from the Host Contract and accounted for as a derivative liability. The estimated fair value of the derivative feature is recorded separately from the carrying value of the Host Contract, with subsequent changes in the estimated fair value recorded as a non-operating gain or loss in the Company’s consolidated statements of operations.
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Income Taxes
The Company accounts for income taxes using the asset and liability method. Under this method, deferred income tax assets and liabilities that are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are in effect when the differences are expected to be recovered or settled. Realization of deferred income tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred income tax asset will not be realized based on the weight of available evidence, including expected future earnings.
The Company recognizes uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is computed as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This calculation is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. Interest and penalties related to income taxes will be recognized as a component of income tax expense.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of outstanding shares of common stock and pre-funded warrants that are accounted for as equity instruments. Common shares associated with pre-funded warrants are included in the computation of both basic and diluted net loss per share since the exercise price is negligible and all of the pre-funded warrants are fully vested and exercisable.
Diluted net loss per share is computed using the treasury stock method by further giving effect to all potential shares of common stock, including stock options, unvested RSUs, and Legacy Warrants (defined in Note 8), to the extent dilutive.
For participating warrants that are entitled to participate in dividends declared to holders of shares of common stock, the Company applies the two-class method of allocating earnings if the impact of including the participating warrants is dilutive for the calculation of both basic and diluted net loss per share.
Recent Accounting Pronouncements
*Recently Adopted Accounting Standard.*The following accounting standard was adopted for the fiscal year ended June 30, 2026:
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”). The implementation of this standard establishes a requirement to disclose differences between the statutory tax rate and the effective tax rate by jurisdiction and disaggregated information about income taxes paid, income (loss) from continuing operations before income tax expense (or benefit) and income tax expense (or benefit) from continuing operations. The Company implemented the guidance in ASU 2023-09 for the fiscal year ended June 30, 2026 and retrospectively for the fiscal year ended June 30, 2025 (see Note 9). The adoption of ASU 2023-09 did not have any material impact on the accompanying consolidated financial statements.
*Standard Required to be Adopted in Future Periods.*The following accounting standard has not yet been adopted by the Company:
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. ASU 2024-03 is effective for annual periods beginning after December 15, 2026. The Company is required
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to adopt ASU 2024-03 in its annual financial statements for the fiscal year ending June 30, 2028, and for interim periods thereafter.
The adoption of ASU 2024-03 and other accounting standards that have been issued or proposed by the FASB 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 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 June 30, 2026, the Company had an accumulated deficit of $481.4 million, and the Company’s capital resources consisted of cash and cash equivalents of $10.6 million and marketable debt securities totaling $97.2 million.
As of June 30, 2026, the Company had total liabilities of $12.2 million, including total current liabilities of $11.4 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 discussed in Note 5, a $25.0 million milestone payment will be due upon regulatory approval of ersodetug by any regulatory authority. The commitment to pay the $25.0 million for regulatory approval of ersodetug is not expected to be recognized as a liability within the next 12 months.
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 carry out ongoing clinical trials and other planned activities for at least 12 months from the issuance date of the consolidated financial statements for the year ended June 30, 2026.
NOTE 3 — INVESTMENTS IN MARKETABLE DEBT SECURITIES
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 the 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 June 30, 2026, all investments in marketable debt securities with an aggregate fair value of $97.2 million are scheduled to mature during the 12-month period ending June 30, 2027.
During the fiscal year ended June 30, 2026, marketable debt securities for $157.1 million matured and approximately $178.2 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 fiscal years ended June 30, 2026 and 2025.
Accrued interest receivable on all marketable debt securities amounted to $0.5 million and $0.7 million as of June 30, 2026 and 2025, respectively. Accrued interest is included in other current assets in the accompanying consolidated balance sheets.
For the fiscal years ended June 30, 2026 and 2025, the Company didnot recognize any allowance for credit losses or impairment related to investments in marketable debt securities.
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The following table summarizes the unrealized gains and losses that result in differences between the amortized cost basis and fair value of the Company’s marketable debt securities held as of June 30, 2026 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Gross Unrealized · · · | ||||||||||||
| · · Amortized Cost · · Gains · · Losses · · Fair Value | ||||||||||||
| Corporate commercial paper | | $41,935 | | $— | | $(57) | | $41,878 | ||||
| U.S. Treasury obligations | | | 4,008 | | | — | | | (2) | | | 4,006 |
| Corporate notes and bonds | | | 51,362 | | | — | | | (60) | | | 51,302 |
| Total | | $97,305 | | $— | | $(119) | | $97,186 | ||||
The following table summarizes the unrealized gains and losses that result in differences between the amortized cost basis and fair value of the Company’s marketable debt securities held as of June 30, 2025 (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Gross Unrealized · · · | ||||||||||||
| · · Amortized Cost · · Gains · · Losses · · Fair Value | ||||||||||||
| Corporate commercial paper | | $16,595 | | $1 | | $(8) | | $16,588 | ||||
| Obligations of U.S. government agencies | | | 5,447 | | | — | | | (2) | | | 5,445 |
| U.S. Treasury obligations | | | 1,485 | | | — | | | (1) | | | 1,484 |
| Corporate notes and bonds | | | 50,231 | | | 18 | | | (15) | | | 50,234 |
| Total | | $73,758 | | $19 | | $(26) | | $73,751 | ||||
NOTE 4 — LEASES
In October 2023, the Company entered into an addendum to the lease agreement for its office in Bend, Oregon. The addendum provided for a 36-month extension, resulting in a new expiration date in February 2027. The average base rent payable over the remaining lease term is approximately $9,000 per month. Upon execution of the addendum, the Company re-measured the Bend, Oregon operating lease liability at approximately $352,000 using a discount rate of 10.0%, and the related right-of-use asset was recognized for approximately $346,000.
In April 2022, the Company entered into a lease agreement for its corporate headquarters facility in Redwood City, California. The space consists of approximately 9,300 square feet and provided for total base rent payments of approximately $2.9 million through the expected expiration of the lease in October 2027. Prior to occupancy, the landlord was required to make improvements to the facility that were completed in October 2022, triggering the commencement of the lease. The lease provided for asix-month rent abatement period beginning upon commencement of the lease term. In addition, the lease provided an allowance of approximately $0.1 million that was utilized by the Company for the purchase of furniture and equipment. The average base rent payable in cash over the 60-month lease term is approximately $48,000 per month. Upon commencement of the lease, the Company recognized a right-of-use asset for approximately $2.3 million, and a related operating lease liability for approximately $2.2 million.
As of June 30, 2026 and 2025, the carrying values of all of the Company’s right-of-use assets and the related operating lease liabilities were as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||
| Right-of-use assets | | $769 | | $1,348 | ||
| | | | | | | |
| Operating lease liabilities: | | | | | ||
| Current | | $658 | | $632 | ||
| Long-term | | 276 | | 983 | ||
| Total | | $934 | | $1,615 | ||
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For the fiscal years ended June 30, 2026 and 2025, operating lease expense is included under the following captions in the accompanying consolidated statements of operations (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Research and development | | $491 | | $489 |
| General and administrative | | 231 | | 178 |
| Total | | $722 | | $667 |
In addition to base rent expense, the Company’s facility leases require variable payments, including the proportionate share of the real estate taxes, building insurance and common area maintenance costs related to the facilities. These variable payments are excluded from the determination of operating lease liabilities and amounted to an aggregate of $0.1 million for each of the fiscal years ended June 30, 2026 and 2025.
As of June 30, 2026, the weighted-average remaining lease term under operating leases was 1.3 years, and the weighted-average discount rate used to determine the operating lease liabilities was 7.0%. As of June 30, 2025, the weighted-average remaining lease term under operating leases was 2.3 years, and the weighted-average discount rate used to determine the operating lease liabilities was 7.1%.
Future Lease Payments
Future payments under all operating lease agreements as of June 30, 2026 are as follows (in thousands):
| | | | |
|---|---|---|---|
| Fiscal year ending June 30, | | | |
| 2027 | | $750 | |
| 2028 | | | 224 |
| Total lease payments | | | 974 |
| Less imputed interest | | (40) | |
| Present value of operating lease liabilities | | $934 |
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.
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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 additional milestone payments to ActiveSite up to $42.5 million. 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. (“SLR”) and certain other lenders (collectively, the “Lenders”). The Lenders agreed to loan up to $30.0 million, but the actual amount borrowed by the Company amounted to $15.0 million. The maturity date of the outstanding borrowings was April 1, 2026 (the “Maturity Date”), but the Company elected to repay the entire amount and terminated the Loan Agreement on June 30, 2022.
Concurrently with the execution of the Loan Agreement, the Company entered into an exit fee agreement (the “Exit Fee Agreement”) that provides for a fee of 4.00% of the funded principal balance for a total of $0.6 million in the event certain transactions (defined as “Exit Events”) occur prior to April 13, 2031. The Exit Fee was not eliminated by termination of the Loan Agreement discussed above. The Company is accounting for the Exit Fee Agreement as an embedded derivative liability with an estimated fair value of $0.5 million as of June 30, 2026 and 2025. Exit Events include, but are not limited to, sales of substantially all assets, certain mergers, change of control transactions, and issuances of common stock that result in new investors owning more than 35% of the Company’s shares. Fair value of embedded derivatives is assessed at the end of each reporting period with changes in fair value recognized as a 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”) exercisable to purchase an aggregate of 28,237,901 shares of common stock. As of June 30, 2026 and 2025, 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. Exercise prices of 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
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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.
The following table summarizes PFW activity for the fiscal years ended June 30, 2026 and 2025:
| | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| | 2021 | | 2022 | | Exchange | | 2024 | | 2025 | | |
| | PFWs | | 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 |
| Issuance of 2025 PFWs in April 2025 | — | | — | | — | | — | | 6,905,385 | (5) | 6,905,385 |
| Cashless exercise of PFWs: | | | | | | | | | | | |
| Shares surrendered for exercise price | — | | (435) | (6) | (616) | (6) | — | | — | | (1,051) |
| Shares of common stock issued | — | | (2,525,883) | (7) | (2,999,384) | (7) | — | | — | | (5,525,267) |
| Outstanding, June 30, 2025 | 123,000 | | 5,621,053 | | — | | 3,750,000 | | 6,905,385 | | 16,399,438 |
| Cashless exercise of PFWs: | | | | | | | | | | | |
| Shares surrendered for exercise price | — | | (377) | (6) | — | | (248) | (6) | (496) | (6) | (1,121) |
| Shares of common stock issued | — | | (2,199,623) | (7) | — | | (1,874,752) | (7) | (4,149,504) | (7) | (8,223,879) |
| Outstanding, June 30, 2026 | 123,000 | | 3,421,053 | | — | | 1,875,000 | | 2,755,385 | | 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 a securities exchange agreement in March 2024 (the “Exchange PFWs”). The exercise price of the Exchange PFWs was $0.001 per share. |
| (4) | Issued in connection with an underwritten offering in June 2024 at an issuance price of $3.999 per share (the “2024 PFWs”). The exercise price of the 2024 PFWs is $0.001 per share. |
| (5) | As discussed below under the caption 2025 Underwritten Offering, the Company issued 2025 PFWs for the purchase of 6,905,385 shares of common stock on April 24, 2025. The exercise price of the 2025 PFWs is $0.001 per share. |
| (6) | Holder of PFWs provided notice of cashless exercise that resulted in cancellation of shares in lieu of paying the exercise price in cash. |
| (7) | Represents the number of shares issued after giving effect to shares surrendered due to the cashless exercise notification by the holder. |
2025 Private Placement
In May 2025, the Company entered into a securities purchase agreement (the “2025 SPA”) with Handok, Inc. and two other investors relating to a private placement (the “2025 Private Placement”), pursuant to which 1,295,383 shares of common stock were issued at a purchase price of $3.25 per share. Closing of the 2025 Private Placement occurred in June 2025, resulting in net proceeds of $4.2 million.
2025 Underwritten Offering
On April 23, 2025, the Company entered into an underwriting agreement with Guggenheim Securities, LLC (the “2025 Underwriter”) for the planned issuance and sale of equity securities in an underwritten public offering (the “2025 Underwritten Offering”). The 2025 Underwritten Offering resulted in the issuance of (i)20,786,923 shares of common stock at a price of $3.25 per share for gross proceeds of approximately $67.6 million, (ii)4,153,846 shares of common stock pursuant to a 30-day option, which was fully exercised during closing, at a public offering price of $3.25 per share (the “2025 Underwriters’ Option”) for gross proceeds of $13.5 million, and (iii) pre-funded warrants to purchase 6,905,385 shares of common stock at a public offering price of $3.249 per pre-funded warrant (the “2025 PFWs”) for gross proceeds of approximately $22.4 million. Closing occurred on April 24, 2025, whereby the aggregate gross
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proceeds from the 2025 Underwritten Offering amounted to approximately $103.5 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 approximately $6.7 million, the net proceeds of the 2025 Underwritten Offering amounted to approximately $96.8 million.
Subject to certain exceptions, as a condition of the 2025 Underwritten Offering, the Company’s executive officers and directors and certain of the Company’s stockholders agreed not to sell or otherwise dispose of any of the shares of Common Stock held by them for a period beginning on the date of execution of the applicable lock-up agreements by each such executive officer, director and stockholder and ending on July 22, 2025 without first obtaining the written consent of the 2025 Underwriter.
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.
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 provided 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 Sales Agreement 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 October 2025, the Company provided the Agent with notice of termination of the Sales Agreement. Accordingly, the Company had the maximum amount remaining for sale under the Sales Agreement of $50.0 million at the date of termination sinceno shares were ever issued under this agreement.
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 June 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 | | 20,193,552 | | 13,664,566 | | 6,528,986 |
| Inducement Awards | | 1,500,000 | | 705,000 | | 795,000 |
| Total | 22,022,752 | 14,698,766 | (1) | 7,323,986 | ||
| (1) | Consists of approximately 12.5 million shares outstanding under stock option agreements and 2.2 million shares under restricted stock units. |
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The Company currently hasone active equity incentive plan approved by shareholders which is the 2021 Plan. On November 19, 2025, the Company’s shareholders approved an amendment to the 2021 Plan, increasing the authorized number of shares of common stock to 21,950,000 shares of common stock, before accounting for reductions due to exercises. The 2021 Plan terminates on March 31, 2030. Pursuant to the 2021 Plan, no awards may be granted under the three legacy equity incentive 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. Awards outstanding under these plans 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 equity incentive plans. As of June 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 June 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 shares of the Company’s common stock through accumulated payroll deductions.
The 2022 ESPP permits 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 June 30, 2026.
Stock Options Outstanding
The following table summarizes the combined stock option activity under the Company’s equity incentive plans and inducement awards, for the fiscal years ended June 30, 2026 and 2025:
| | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||||||||||
| · · Shares · · Price (1) · · Term (2) · · Shares · · Price (1) · · Term (2) | ||||||||||||||
| Outstanding, beginning of fiscal year | 13,027,994 | | $4.03 | 7.7 | | 10,890,540 | | $3.82 | | 8.1 | ||||
| Granted | | 2,506,000 | | | 8.64 | | | | 3,246,300 | | | 4.57 | | |
| Exercised | | (825,953) | (3) | | 2.18 | | | | (488,742) | (3) | | 2.85 | | |
| Expired | | (346,745) | | | 4.86 | | | | (69,666) | | | 12.17 | | |
| Forfeited | | (1,892,865) | | | 6.22 | | | | (550,438) | | | 3.08 | | |
| Outstanding, end of fiscal year | 12,468,431 | (4) | 4.73 | 6.9 | | 13,027,994 | (4) | 4.03 | 7.7 | |||||
| Vested, end of fiscal year | 9,145,633 | (5) | 4.37 | 6.2 | | 7,127,835 | (5) | 4.48 | 6.9 | |||||
| (1) | Represents the weighted average exercise price. |
| (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 year ended June 30, 2026 and 2025, was $2.5 million and $0.9 million, respectively. |
| (4) | As of June 30, 2026 and 2025, the intrinsic value of outstanding stock options was approximately $19.4 million and $14.9 million, respectively. |
| (5) | As of June 30, 2026 and 2025, the aggregate intrinsic value of vested stock options was approximately $16.1 million and $8.5 million, respectively. |
For the fiscal year ended June 30, 2026, the aggregate fair value of stock options granted for approximately 2.5 million shares of common stock amounted to $15.7 million or approximately $6.26 per share as of the grant dates. For the fiscal
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year ended June 30, 2025, the aggregate fair value of stock options granted for approximately 3.2 million shares of common stock amounted to $10.8 million or approximately $3.32 per share as of the grant dates. Unrecognized share-based compensation expense related to outstanding options was approximately$12.6 million as of June 30, 2026. This amount is expected to be recognized over a weighted average period of 2.2 years.
Fair value of stock options was computed using the BSM option-pricing model and will result in the recognition of compensation expense on a straight-line basis over the expected vesting period of the stock options. The determination of the fair value of share-based awards utilizing the BSM model is affected by the share price and a number of assumptions as of the grant date, including expected volatility, expected term, risk-free interest rate and expected dividends. The Company determined the expected volatility by using share price information of similar sized biotechnology entities who are in similar stages of clinical development and whose share prices are publicly available. Due to the lack of a meaningful history of exercise behavior of stock options, the expected term of the awards is determined by the simplified method that uses the midpoint between the vesting date and the end of the contractual term for each grant of stock options. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected terms of the awards. The dividend yield assumption is based on past practices and the expectation that no dividends will be paid in the future.
The fair value of stock options was estimated on the dates of grant using the BSM option-pricing model, with the following weighted-average assumptions for the fiscal years ended June 30, 2026 and 2025:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | |||||||
| Market price of common stock on grant date | | $8.64 | | $4.57 | | ||
| Expected volatility | | | 84% | | 84% | ||
| Risk free interest rate | | 3.8% | | 4.2% | |||
| Expected term (years) | | 5.9 | | | 5.9 | | |
| Dividend yield | | 0% | | 0% | |||
Restricted Stock Units (“RSUs”)
The following table summarizes the RSU activity under the Company’s 2021 Plan, for the fiscal years ended June 30, 2026 and 2025:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||||||
| · · Shares · · Price (1) · · Shares · · Price (1) | ||||||||||
| Unvested, beginning of fiscal year | 1,056,500 | | $4.55 | | — | | $— | |||
| Granted | | 1,915,000 | | | 10.11 | | 1,056,500 | | | 4.55 |
| Vested | | (360,165) | (2) | | 4.61 | | — | | | — |
| Forfeited | | (381,000) | | | 9.56 | | — | | | — |
| Unvested, end of fiscal year | 2,230,335 | | 8.46 | | 1,056,500 | | 4.55 | |||
| (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 fiscal year ended June 30, 2026, amount to $1.2 million or approximately $3.24 per share. |
For the fiscal year ended June 30, 2026, the aggregate fair value of RSUs granted for approximately 1.9 million shares of common stock amounted to$19.4 million. Grants of RSUs vest over a period ofone tofour years after the grant dates. Fair value is based on the closing market price on the date of grant and will result in the recognition of compensation coston a straight-line basis over the vesting period of the RSUs. Unrecognized share-based compensation expense related to
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RSUs is approximately$14.5 million as of June 30, 2026. This amount is expected to be recognized over a weighted average period of 2.1 years.
Share-Based Compensation Expense
Share-based compensation expense is included under the following captions in the consolidated statements of operations for the fiscal years ended June 30, 2026 and 2025 (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Research and development | | $6,473 | | $3,502 |
| General and administrative | | 7,987 | | 3,619 |
| Total | | $14,460 | | $7,121 |
The aggregate unrecognized share-based compensation expense for stock options and RSUs as of June 30, 2026 was approximately $27.1 million. This amount is expected to be recognized over a remaining weighted average period of 2.1 years.
Inducement Grants
In connection with the appointment of the Company’s Chief Commercial Officer in August 2025 the Board of Directors approved the grant of stock options exercisable for the purchase of 275,000 shares of the Company’s common stock at an exercise price of$6.55 per share. These stock options qualify as inducement grants pursuant to Nasdaq Listing Rule 5635(c)(4) whereby the underlying shares were not authorized under any of the Company’s stock option plans (“Inducement Awards”). The stock options are exercisable until August 2035 and vest for (i)one-fourth of the option shares on the one-year anniversary of the employee start date, and (ii)one thirty-sixth of the remaining option shares vest on the same day of each month thereafter until the stock options are 100% vested. The fair value of this Inducement Award of$1.3 million was computed using the Black-Scholes-Merton (“BSM”) option-pricing model.
Additionally, in connection with the hiring offour employees during the fiscal year ended June 30, 2026, the Company issued additional Inducement Awards, consisting of stock options exercisable for the purchase of an aggregate of 370,000 shares of the Company’s common stock. These stock options are exercisable for aten-year term and vest for (i)one-fourth of the option shares on the one-year anniversary of each employee’s start date, and (ii)one thirty-sixth of the remaining option shares vest on the same day of each month thereafter until the stock options are 100% vested.
Pre-Funded Warrants
PFWs are outstanding for a total of 8.2 million and 16.4 million shares as of June 30, 2026 and 2025, respectively. Please refer to Note 7 for additional information about outstanding PFWs and Note 13 for treatment of PFWs in the calculation of earnings per share.
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. 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 to purchase shares of common stock in conjunction with other debt and equity financings and for services. As of June 30, 2026 and 2025, all of the warrants were vested. The Participating Warrants and other warrants are collectively referred to as the “Legacy Warrants.”
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For the fiscal years ended June 30, 2026 and 2025, no Legacy Warrants were granted or exercised. The following table summarizes the activity related to the Legacy Warrants for the fiscal years ended June 30, 2026 and 2025:
| · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||||||
| · · Shares · · Price (1) · · Term (2) · · Shares · · Price (1) · · Term (2) | ||||||||||
| Outstanding, beginning of fiscal year | 850,442 | | $19.90 | 2.3 | 860,562 | | $20.28 | 3.2 | ||
| Expirations | (660) | | | 67.55 | | (10,120) | | | 52.20 | |
| Outstanding, end of fiscal year | 849,782 | | 19.86 | 1.3 | 850,442 | | 19.90 | 2.3 | ||
| (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 — INCOME TAXES
Net Operating Loss Carryforwards
The Company files income tax returns in the U.S. federal jurisdiction and in several states including, but not limited to, California, Colorado, and Oregon. The Company’s federal and state tax returns for the 2023 fiscal year and forward are subject to examination by taxing authorities. Federal and state laws impose substantial restrictions on the utilization of federal net operating loss (“NOL”) carryforwards in the event of an ownership change for income tax purposes, as defined in Section 382 of the Internal Revenue Code (“IRC”). Pursuant to IRC Section 382, annual use of the Company’s NOL carryforwards is limited whenever a cumulative change in ownership of more than 50% occurs within any rolling three-year period. During the fiscal year ended June 30, 2026, the Company completed an IRC Section 382 analysis and concluded that while the Company did not experience an IRC Section 382 ownership change for the year, the Company’s NOL carryforwards are still subject to limitations as a result of prior ownership changes. The Company had $248.9 million of U.S. federal NOL carryforwards as of June 30, 2026, of which $33.4 million will expire without any opportunity for utilization due to the limitations set forth in IRC Section 382. Our ability to use the remaining $215.5 million of U.S. federal NOL carryforwards is subject to strict limitations as a result of prior ownership changes.
As of June 30, 2026, the Company had the following NOL carryforwards, which if not utilized, will expire as follows (in thousands):
| | | | | | |
|---|---|---|---|---|---|
| · · Amount · · Expiration Years | |||||
| Federal net operating loss carryforwards | | $194,235 | | Indefinite | |
| Federal net operating loss carryforwards | | | 21,305 | | 2031 - 2038 |
| California net operating loss carryforwards | | | 213,709 | | 2039 - 2045 |
| Colorado net operating loss carryforwards | | | 26,499 | | Indefinite |
| Colorado net operating loss carryforwards | | | 39,690 | | 2031 - 2037 |
It should be noted that with respect to $72.4 million of the $194.2 million of NOL carryforwards in the table above that do not expire, these NOLs are subject to more restrictive IRC Section 382 limitations, and as such will become available in varying annual amounts for an aggregate of approximately $6.6 million through fiscal year 2038, and $1.2 million annually thereafter. In addition, with respect to the $21.3 million of NOL carryforwards in the table above that expire beginning in 2031 through 2038 if not utilized, $11.3 million is currently available to offset taxable income and the remaining $10.0 million will become available through 2038. The Company’s state NOLs carryforwards are also expected to be subject to similar limitations as those imposed under IRC Section 382.
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Income Tax Expense
For the fiscal years ended June 30, 2026 and 2025, the reconciliation between the income tax benefit computed by applying the statutory U.S. federal income tax rate to the pre-tax loss before income taxes, and total income tax expense recognized in the consolidated financial statements is as follows (in thousands):
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||||||
| Income tax benefit at statutory U.S. federal rate | | $16,293 | | 21% | | $15,626 | | 21% | ||
| Income tax benefit attributable to U.S. states (1) | | 5,543 | | 7% | | 5,042 | | 7% | ||
| Non-deductible expenses | | (400) | | (1)% | | (464) | | (1)% | ||
| Other | | | 604 | | 1% | | | (32) | | 0% |
| Change in valuation allowance | | (22,040) | | (28)% | | (20,172) | | (27)% | ||
| Total income tax expense | | $— | | 0% | | $— | | 0% | ||
| (1) | State taxes in California comprise the majority (greater than 50%) of the tax effect in this category. |
For the fiscal years ended June 30, 2026 and 2025, the Company did not recognize any current income tax expense or benefit due to a full valuation allowance on its net deferred income tax assets.
Deferred Income Tax Assets and Liabilities
As of June 30, 2026 and 2025, the income tax effects of temporary differences that give rise to significant deferred income tax assets and liabilities are as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||
| Deferred income tax assets: · · · · | ||||||
| Federal net operating loss carryforwards | | $45,263 | | $35,291 | ||
| State net operating loss carryforwards | | | 17,225 | | | 15,758 |
| Research and experimental costs | | | 33,864 | | | 25,074 |
| Share-based compensation | | 8,192 | | 5,650 | ||
| Intangible assets | | | 6,607 | | | 7,285 |
| Accrued expenses and other | | 778 | | 802 | ||
| Operating lease liabilities | | | 261 | | | 452 |
| | | | | | | |
| Total deferred income tax assets | | 112,190 | | 90,312 | ||
| Valuation allowance for deferred income tax assets | | (111,975) | | (89,935) | ||
| | | | | | | |
| Deferred income tax assets, net of valuation allowance | | | 215 | | | 377 |
| | | | | | | |
| Deferred income tax liability right-of-use assets | | | (215) | | | (377) |
| | | | | | | |
| Net deferred income tax assets | | $— | | $— | ||
For the fiscal years ended June 30, 2026 and 2025, the valuation allowance increased by $22.0 million and $20.2 million, respectively, primarily as a result of an increase in net operating loss carryforwardsand capitalization of research and experimental costs for income tax purposes. In assessing the realizability of deferred income tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized.
On July 4, 2025, the One Big Beautiful Bill Act ("OBBBA") was signed into law. Key elements of the Tax Cuts and Jobs Act of 2017 changed under the OBBBA, including options on how to account for domestic research or experimental
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expenditures. FASB ASC 740, "Income Taxes", requires the effects of changes in tax rates and laws on tax balances to be recognized in the period in which the legislation is enacted. During the fiscal year ended June 30, 2026 the Company elected to capitalize and amortize its domestic research and experimental expenditures on a straight-line basis over no less than 60 months, beginning with the month in which the taxpayer first realizes benefits from those expenditures. The Company does not expect to realize benefits from these capitalized expenditures until it is able to commercialize its product candidates. The changes in the OBBBA did not have a material impact on the Company’s net deferred tax assets or the accompanying consolidated financial statements.
Unrecognized Tax Benefits
The Company did not have any unrecognized tax benefits as of June 30, 2026 and 2025. The Company’s policy is to account for any interest expense and penalties for unrecognized tax benefits as part of the income tax provision. The Company does not anticipate that unrecognized tax benefits will significantly increase or decrease within the next twelve months.
NOTE 10 — 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.
Employment Agreements
Certain members of management are entitled to severance benefits payable upon termination following a change in control. The aggregate change in control payment related to these individual’s salaries amounted to approximately $6.7 million and $3.7 million for the fiscal years ended June 30, 2026 and 2025, respectively. Additionally, the pro-rata bonus amount earned as of the date of a termination event and the acceleration of vesting for certain stock-based compensation would occur following a change in control based on the terms of each employee’s respective employment agreement.
Amended Employment Agreements
On October 17, 2025, the Company entered into amendments to employment agreements with four officers of the Company. The amendments entitle each of the executive officers to a full gross-up payment (the “Gross-Up Payment”) for any excise tax imposed by Section 4999 of the Internal Revenue Code (the “IRC”) and other local, state and federal taxes imposed if an excess parachute payment is paid in connection with a future change of control event, as determined under Section 280G of the IRC. The determination of the amount of any Gross-Up Payment will be made by the Company in its sole discretion. Except for the provisions related to Gross-Up Payments, all other terms of the respective employment agreements were unchanged.
401(k) Plan
The Company has a defined contribution employee benefit plan under section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all eligible employees who are entitled to participate beginning six months after the commencement of employment. The Company matches contributions up to 4% of the participating employee’s compensation with such matching contributions vested immediately. Total contributions by the Company to the 401(k) Plan amounted to approximately $0.5 million for the fiscal years ended June 30, 2026 and 2025.
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Legal Matters
From time to time, the Company may be involved in litigation relating to claims arising out of operations in the normal course of business. As of June 30, 2026, there have been several law firms that have initiated investigations into the Company and have filed press releases seeking stockholders to engage them to file litigation against the Company for alleged securities law violations related to the Company’s Phase 3 sunRIZE trial not meeting its primary endpoint or key secondary endpoint. To date, 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. At each reporting period, the Company evaluates whether or not a potential loss or a potential range of loss is probable and reasonably estimable under ASC 450,Contingencies. Legal fees are expensed as incurred.
NOTE 11 — RELATED PARTY TRANSACTIONS
Related Party Licensing Agreement
On September 15, 2020, the Company entered into an exclusive license agreement with Handok (the “Handok License”) for the territory of the Republic of Korea. The Handok License relates to pharmaceutical products in final dosage form containing the pharmaceutical compounds developed or to be developed by the Company, including those related to 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 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 of the total $6.0 million gross proceeds.
Investors in 2025 Private Placement
Handok was an investor in the 2025 Private Placement discussed in Note 7 for which the Company issued 1,230,769 shares of common stock at a purchase price of $3.25 per share resulting in gross proceeds of $4.0 million. A member of the Company’s Board of Directors was also an investor in the 2025 Private Placement for which the Company issued 3,076 shares at a purchase price of $3.25 per share resulting in gross proceeds of $9,997.
NOTE 12 - SUPPLEMENTAL FINANCIAL INFORMATION
Cash and cash equivalents
Cash and cash equivalents consisted of the following as of June 30, 2026 and 2025 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||
| Money market funds | | $6,102 | | $86,059 | ||
| Demand deposits at a single financial institution | | | 4,513 | | | 5,052 |
| U.S. Government treasuries | | | — | | | 1,996 |
| Corporate commercial paper | | | — | | | 1,000 |
| Total | | $10,615 | | $94,107 | ||
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The money market funds, commercial paper, and U.S government treasuries included in the table above were purchased with an original maturity of three months or less. These investments and the demand deposits are freely available for the Company’s immediate and general business use.
Property and Equipment
Property and equipment consisted of the following as of June 30, 2026 and 2025 (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Office furniture and equipment | | $210 | | $210 |
| Less accumulated depreciation | | (169) | | (138) |
| Total | | $41 | | $72 |
Depreciation expense related to property and equipment amounted to approximately $31,000 for each of the fiscal years ended June 30, 2026 and 2025.
NOTE 13 — 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 since the exercise price is negligible and all of the PFWs are fully vested and exercisable.
Calculation of the weighted average number of shares outstanding for purposes of diluted net loss per share is also required to include the dilutive effect, if any, of stock options, RSUs, Legacy Warrants, and other common stock equivalents computed using the treasury stock method. For the fiscal years ended June 30, 2026 and 2025, all of such common stock equivalents were antidilutive and excluded from the calculations. In addition, the impact of applying the two-class method related to the Participating Warrants, was antidilutive for the calculation of both basic and diluted net loss per share.
Presented below are the numerators and the denominators used in the calculation of basic and diluted net loss per share for the fiscal years ended June 30, 2026 and 2025 (in thousands except share and per share amounts):
| | | | | | | |
|---|---|---|---|---|---|---|
| | 2026 | | 2025 | |||
| Numerator: | | | | | | |
| Net loss | | $(77,586) | | $(74,412) | ||
| | | | | | | |
| Denominator: | | | | | | |
| Weighted average number of common shares outstanding | | | 93,772,033 | | | 63,599,003 |
| Weighted average shares related to pre-funded warrants: | | | | | | |
| 2021 PFWs | | | 123,000 | | | 123,000 |
| 2022 PFWs | | | 3,595,699 | | | 6,520,837 |
| Exchange PFWs | | | — | | | 719,967 |
| 2024 PFWs | | | 2,359,982 | | | 3,750,000 |
| 2025 PFWs | | | 4,056,400 | | | 1,286,483 |
| Weighted average shares outstanding | | | 103,907,114 | | | 75,999,290 |
| | | | | | | |
| Net loss per share of common stock: | | | | | | |
| Basic and diluted | | $(0.75) | | $(0.98) | ||
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As of June 30, 2026 and 2025, the following potential common stock equivalents were excluded from the calculation of diluted net loss per share since the impact of inclusion was anti-dilutive:
| | | | | |
|---|---|---|---|---|
| | | 2026 | | 2025 |
| Stock options | | 12,468,431 | | 13,027,994 |
| RSUs | | 2,230,335 | | 1,056,500 |
| Legacy Warrants | | 849,782 | | 850,442 |
| Total | | 15,548,548 | | 14,934,936 |
NOTE 14 — 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.
Assets Measured at Fair Value on a Recurring Basis
The following table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the fair value hierarchy classification of such fair values as of June 30, 2026.
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · | ||||||||||||
| · · 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 | | | — |
| U.S. Government treasuries | | | 4,006 | | | — | | | 4,006 | | | — |
| Corporate notes and bonds | | | 51,302 | | | — | | | 51,302 | | | — |
| Total | | $103,288 | | $6,102 | | $97,186 | | $— | ||||
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The following table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the fair value hierarchy classification of such fair values as of June 30, 2025.
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurement of Assets as of June 30, 2025 | ||||||||||||
| · · Total · · Level 1 · · Level 2 · · Level 3 | ||||||||||||
| Cash and cash equivalents: | | | | | | | | | | | | |
| Money market funds | | $86,059 | | $86,059 | | $— | | $— | ||||
| Corporate commercial paper | | | 1,000 | | | — | | | 1,000 | | | — |
| U.S. Government treasuries | | | 1,996 | | | — | | | 1,996 | | | — |
| Marketable debt securities: | | | | | | | | | | | | |
| Corporate commercial paper | | | 16,588 | | | — | | | 16,588 | | | — |
| U.S. Government agencies | | | 5,445 | | | — | | | 5,445 | | | — |
| U.S. Government treasuries | | | 1,484 | | | — | | | 1,484 | | | — |
| Corporate notes and bonds | | | 50,234 | | | — | | | 50,234 | | | — |
| Total | | $162,806 | | $86,059 | | $76,747 | | $— | ||||
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 tables above, the Company did not have any other assets measured at fair value on a recurring basis as of June 30, 2026 and 2025.
Liabilities Measured at Fair Value on a Recurring Basis
For the fiscal years ended June 30, 2026 and 2025, the Company’s only liability that was required to be measured and recorded at fair value on a recurring basis is the embedded derivative liability discussed in Note 6. Fair value of the embedded derivative liability 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 prior to termination. The fair value of the embedded derivative liability was $0.5 million as of June 30, 2026 and 2025.
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 June 30, 2026 and 2025. The Company’s policy is to recognize asset or liability transfers among Level 1, Level 2 and Level 3 as of the actual date of the events or change in circumstances that caused the transfer. During the fiscal years ended June 30, 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 and cash equivalents and investments in marketable debt securities. The Company maintains its cash in demand accounts at a high-quality financial institution. As of and for the fiscal years ended June 30, 2026 and 2025, cash deposits have exceeded the amount of insurance provided on such deposits by the Federal Deposit Insurance Corporation.
As of June 30, 2026, the Company had an aggregate of $55.4 million invested in marketable debt securities of issuers in the banking and financial services industries. As of June 30, 2025, the Company had an aggregate of $45.2 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.
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NOTE 15 — 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 net loss as reported on the consolidated statement of operations 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 consolidated balance sheet 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 years ended June 30, 2026, and 2025 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · 2026 · · 2025 | ||||||
| Research and development: · · · · · | ||||||
| Ersodetug | | $24,150 | | $31,752 | ||
| Compensation and benefits | | | 23,434 | | | 19,404 |
| Other research and development segment expenses (1) | | | 6,214 | | | 10,371 |
| Total research and development | | 53,798 | | | 61,527 | |
| General and administrative: | | | | | | |
| Compensation and benefits | | | 16,954 | | | 10,756 |
| Other general and administrative segment expenses (2) | | | 12,214 | | | 7,611 |
| Total general and administrative | | 29,168 | | | 18,367 | |
| Operating loss | | | (82,966) | | | (79,894) |
| Total non-operating income, net | | | 5,380 | | | 5,482 |
| Net loss | | $(77,586) | | $(74,412) | ||
| (1) | Other R&D segment expenses primarily include licensing costs, quality regulatory and other pipeline development costs, employee travel and expense, and other facility and information technology costs. |
| (2) | Other G&A 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 16 — REDUCTION IN WORKFORCE
On December 11, 2025, the Company announced that its Phase 3 sunRIZE clinical trial did not meet its primary endpoint or key secondary endpoint. Management approved a reduction in workforce of 29 employees on December 15, 2025 to reduce overall operating expenses and preserve capital to support the Company’s Phase 3 upLIFT clinical trial and plan for future interactions with the FDA to discuss the full sunRIZE dataset and next steps for the program. The Company incurred$1.5 million of severance expenses in December 2025, consisting of$0.9 million of research and development expense and$0.6 million of general and administrative expense. Total severance benefits of$1.5 million were paid in full to the affected employees in January 2026 andno obligations related to the severance benefits remain as of June 30, 2026.
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.