CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 15, 2024 REZOLUTE, INC. (Exact Name of Registrant as Specified in Charter) Nevada 001-39683 27-3440894 (State or Other Jurisdiction of Incorporation) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K (Commission File Number) (I.R.S. Employer Identification No.) 275 Shoreline Drive, Suite 500, Redwood City, CA 94065 (Address of Principal Exec ...

Table of Contents Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock, par value $0.001 per share | RZLT | Nasdaq Capital Market | Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State or other jurisd ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 REZOLUTE, INC. (Exact Name of Company as Specified in its Charter) | Nevada | | 27-3440894 | | --- | --- | --- | | (State or other jurisdiction of incorporation or organization) | | ( ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State or other jurisdicti ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's financial statements for the period ended December 31, 2022, show a decrease in cash and total assets compared to June 30, 2022, with operating and net losses widening due to increased R&D and G&A expenses, leading to a decrease in shareholders' equity despite stock issuance proceeds, and increased cash usage from operations while financing activities provided less cash than the prior year [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of December 31, 2022, the company had cash and cash equivalents of $146.7 million, a slight decrease from $150.4 million at June 30, 2022, with total assets decreasing to $150.2 million from $152.4 million, total liabilities increasing significantly to $8.9 million from $2.9 million primarily due to new operating lease liabilities, and total shareholders' equity consequently decreasing to $141.3 million from $149.5 million Condensed Consolidated Balance Sheet Data (in thousands) | | December 31, 2022 | June 30, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $146,746 | $150,410 | | Total current assets | $147,606 | $152,104 | | Total assets | $150,208 | $152,420 | | **Liabilities and Shareholders' Equity** | | | | Total current liabilities | $6,313 | $2,462 | | Total liabilities | $8,943 | $2,949 | | Total shareholders' equity | $141,265 | $149,471 | [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended December 31, 2022, the company reported a net loss of $13.6 million, compared to a net loss of $12.6 million for the same period in 2021, while for the six-month period, the net loss was $23.4 million in 2022, up from $20.4 million in 2021, with increased losses primarily driven by higher research and development and general and administrative expenses Operating Results (in thousands, except per share amounts) | | Three Months Ended Dec 31, | Six Months Ended Dec 31, | | :--- | :--- | :--- | | | **2022** | **2021** | **2022** | **2021** | | Research and development | $10,945 | $9,452 | $18,649 | $15,226 | | General and administrative | $3,447 | $2,697 | $5,961 | $4,563 | | Operating loss | $(14,392) | $(12,149) | $(24,610) | $(19,789) | | Net loss | $(13,556) | $(12,593) | $(23,387) | $(20,429) | | Net loss per share (basic and diluted) | $(0.26) | $(0.80) | $(0.46) | $(1.69) | [Unaudited Condensed Consolidated Statements of Shareholders' Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) For the six months ended December 31, 2022, total shareholders' equity decreased from $149.5 million to $141.3 million, primarily due to a net loss of $23.4 million, partially offset by $12.3 million in gross proceeds from common stock issuance in a private placement and $3.6 million in share-based compensation - In the six months ended December 31, 2022, the company raised **$12.3 million** in gross proceeds from a private placement of common stock[17](index=17&type=chunk) - The net loss for the six-month period was **$23.4 million**, which reduced shareholders' equity[17](index=17&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended December 31, 2022, net cash used in operating activities was $15.1 million, an increase from $13.5 million in the prior-year period, while net cash provided by financing activities was $11.6 million, primarily from a private placement, a significant decrease from $54.9 million in the same period of 2021 which included a large underwritten public offering, resulting in a net decrease in cash of $3.7 million for the period Cash Flow Summary (in thousands) | | Six Months Ended December 31, | | :--- | :--- | :--- | | | **2022** | **2021** | | Net Cash Used in Operating Activities | $(15,082) | $(13,538) | | Net Cash Used in Investing Activities | $(153) | $— | | Net Cash Provided by Financing Activities | $11,571 | $54,894 | | Net decrease/increase in cash | $(3,664) | $41,356 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's operations as a clinical-stage biopharmaceutical firm focused on metabolic diseases, highlighting its liquidity status with sufficient cash to operate through February 2024, significant commitments including milestone payments for its RZ358 and RZ402 programs, recent financing activities including a private placement in July 2022, and a subsequent event note on a $3.0 million milestone payment triggered in February 2023 - The company is a clinical-stage biopharmaceutical company developing therapies for metabolic diseases, with primary clinical assets being RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema[23](index=23&type=chunk) - Management believes its cash balance of **$146.7 million** as of December 31, 2022, is adequate to fund operations at least through February 2024[40](index=40&type=chunk) - A **$3.0 million** milestone payment to ActiveSite became due in February 2023 upon dosing the first patient in the RZ402 Phase 2 study[100](index=100&type=chunk) - A **$5.0 million** milestone payment to XOMA for the RZ358 program is expected to be due within the next 12 months upon dosing the first patient in a Phase 3 trial[37](index=37&type=chunk)[46](index=46&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the progress of its lead clinical assets, RZ358 and RZ402, with RZ358 anticipated to start a Phase 3 trial in Summer 2023 and RZ402 having initiated a Phase 2 study in December 2022, while the analysis of financial results shows increased operating expenses due to higher R&D and G&A headcount and clinical trial activities, and the company's liquidity is strong with $146.7 million in cash, deemed sufficient to fund operations and key clinical milestones into early 2024, supported by recent financing activities [Status of Clinical Assets](index=26&type=section&id=Special%20Note%20Regarding%20Status%20of%20Clinical%20Assets) The company is advancing its two main clinical assets, with RZ358 engaging with the FDA and European regulators to finalize Phase 3 study design following positive Phase 2b results, anticipating trial commencement in Summer 2023 and top-line results in Q1 2025, while a Phase 2 study for RZ402 in patients with Diabetic Macular Edema (DME) was initiated in December 2022, with results expected in Q1 2024 - **RZ358:** The company anticipates commencing a Phase 3 study in the Summer of 2023, with top-line results planned for the first quarter of 2025[103](index=103&type=chunk) - **RZ402:** A Phase 2 study for DME was initiated in December 2022. The company expects to complete dosing in the fourth quarter of 2023 and announce results in the first quarter of 2024[105](index=105&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Comparing the periods ended December 31, 2022, and 2021, operating expenses increased for both the three-month and six-month periods, primarily due to higher compensation and benefits from an increased number of employees in both R&D and G&A functions, as well as increased spending on Phase 3 readiness for RZ358 and the Phase 2 trial for RZ402, while interest income also increased significantly due to higher cash balances from recent financings R&D Expense Comparison (in thousands) | Period | 2022 | 2021 | Increase | % Change | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended Dec 31 | $10,945 | $9,452 | $1,493 | 16% | | Six Months Ended Dec 31 | $18,649 | $15,226 | $3,423 | 22% | G&A Expense Comparison (in thousands) | Period | 2022 | 2021 | Increase | % Change | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended Dec 31 | $3,447 | $2,697 | $750 | 28% | | Six Months Ended Dec 31 | $5,961 | $4,563 | $1,398 | 31% | - The increase in R&D and G&A expenses was primarily driven by higher cash-based and share-based compensation due to an increase in the average number of employees[129](index=129&type=chunk)[130](index=130&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, the company had $146.7 million in cash and cash equivalents, which management believes are sufficient to meet contractual obligations and advance clinical trials through the end of 2023, with primary liquidity sources being equity offerings including a $12.3 million private placement in July 2022 and a $117.6 million registered direct offering in May 2022, and significant near-term cash outlays including a $3.0 million milestone payment to ActiveSite made in February 2023 and an anticipated $5.0 million milestone payment to XOMA within the next twelve months - The company held cash and cash equivalents of **$146.7 million** and working capital of **$141.3 million** as of December 31, 2022[141](index=141&type=chunk) - Management believes it has adequate capital to fund planned activities through the fiscal quarter ending December 31, 2023[144](index=144&type=chunk) - A **$3.0 million** milestone payment to ActiveSite for the RZ402 program became payable in February 2023[144](index=144&type=chunk)[150](index=150&type=chunk) - A **$5.0 million** milestone payment to XOMA for the RZ358 program is anticipated within the next twelve months[143](index=143&type=chunk)[149](index=149&type=chunk) [Cash Flows Summary](index=40&type=section&id=Cash%20Flows%20Summary) For the six months ended December 31, 2022, net cash used in operating activities increased to $15.1 million from $13.5 million in the prior year, driven by a higher net loss, while cash used in investing activities was minimal at $0.2 million, and net cash from financing activities was $11.6 million from a private placement, a sharp decrease from $54.9 million in the prior year which benefited from larger public offerings Cash Flow Summary (in thousands) | | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | **Net cash used in operating activities** | $(15,082) | $(13,538) | $(1,544) | | **Net cash used in investing activities** | $(153) | — | $(153) | | **Net cash provided by financing activities** | $11,571 | $54,894 | $(43,323) | [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company for this reporting period - Not applicable[168](index=168&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that as of December 31, 2022, the company's disclosure controls and procedures were not effective due to a material weakness in internal control, stemming from inadequate segregation of duties due to a limited number of employees, and the company is taking remedial steps including implementing more robust accounting software and hiring additional personnel in October 2022 to improve duty segregation - Management identified a material weakness in internal control over financial reporting[169](index=169&type=chunk) - The material weakness is due to the limited number of employees, which has not allowed for adequate segregation of duties to prevent employees from overriding the internal control system[170](index=170&type=chunk) - Remediation efforts include implementing new accounting software and hiring additional personnel in October 2022 to better segregate functions[170](index=170&type=chunk) [PART II – OTHER INFORMATION](index=43&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[173](index=173&type=chunk) [Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended June 30, 2022 - As of the date of this Report, there have been no material changes with respect to the risk factor disclosures in the 2022 Form 10-K[173](index=173&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[175](index=175&type=chunk) [Other Information](index=43&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - None[181](index=181&type=chunk) [Exhibits](index=44&type=section&id=Item%206.%20Exhibits) The report includes several exhibits, most notably amended employment agreements for the CEO and CMO, and standard SEC certification filings - Filed exhibits include amended and restated employment agreements for Nevan Elam (CEO) and Brian Roberts (CMO), dated January 8, 2023[183](index=183&type=chunk) - Certifications pursuant to Section 302 and 906 of the Sarbanes-Oxley Act of 2002 were also filed[183](index=183&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State or other jurisd ...

Financial Performance - The net loss for the fiscal year 2022 was $41,060,000, compared to a net loss of $20,902,000 in 2021, indicating an increase in losses of 96%[231] - The net loss for the fiscal year ended June 30, 2022, was $41,060,000, compared to a net loss of $20,902,000 for the previous year, representing an increase of 96.5%[237] - For the fiscal year ended June 30, 2022, the company reported a net loss of $41.1 million compared to a net loss of $20.9 million for the fiscal year ended June 30, 2021[387] Assets and Liabilities - Total current assets increased to $152,104,000 in 2022 from $41,993,000 in 2021, representing a growth of 262%[230] - Cash and cash equivalents as of June 30, 2022, were $150,410,000, a substantial increase from $41,047,000 in 2021[230] - The company's total liabilities decreased to $2,949,000 in 2022 from $16,510,000 in 2021, a reduction of 82%[230] - The total shareholders' equity increased to $149,471,000 in 2022, compared to $26,099,000 in 2021, reflecting a growth of 472%[230] - As of June 30, 2022, the company had cash and cash equivalents of $150.4 million and total current liabilities of $2.5 million[286] Operating Expenses - Total operating expenses for 2022 were $41,843,000, which is an increase of 83% from $22,894,000 in 2021[231] - Research and development expenses rose significantly to $32,486,000 in 2022, up from $14,987,000 in 2021, marking a 117% increase[231] - Total cash used in operating activities for the fiscal year 2022 was $39,616,000, compared to $20,441,000 in the previous year, indicating a 93.8% increase in cash outflow[237] Financing Activities - The company raised $64,390,000 from the issuance of common stock in the 2022 Registered Direct Offering, net of underwriting discounts[238] - The net cash provided by financing activities in 2022 was $148,979,000, a substantial increase from $51,533,000 in 2021, representing a 188.5% growth[238] - The company received proceeds of approximately $110.5 million from a registered direct offering on May 4, 2022, after underwriting discounts of $7.1 million[288] - In July 2022, the company received gross proceeds of approximately $12.3 million related to a private placement of approximately 3.2 million shares of common stock[289] Shareholder Equity and Stock Options - The weighted average number of common shares outstanding increased to 18,197,000 in 2022 from 7,671,000 in 2021, an increase of 137%[231] - The company issued approximately 18.0 million shares of common stock in the 2022 RDO, utilizing the entire 40.0 million authorized shares available at that time[327] - The company granted stock options for approximately 7.0 million shares at an exercise price of $3.40 per share, with a total fair value of $18.3 million[354] - For the fiscal year ended June 30, 2022, the aggregate fair value of stock options granted was $20.1 million for approximately 7.4 million shares[359] Milestone Payments and Agreements - A $3.0 million milestone payment will be due upon dosing of the first patient in a Phase 2 clinical trial for RZ402[287] - A $5.0 million milestone payment will be due upon dosing of the first patient in a Phase 3 clinical trial for RZ358[287] - The Company made a milestone payment of $2.0 million under the XOMA License Agreement in January 2022, with potential future milestone payments up to $35.0 million[299] Internal Controls and Compliance - The company identified a material weakness in internal control over financial reporting due to inadequate segregation of duties, which had not been remediated as of June 30, 2022[405] - The company has implemented more robust accounting software to strengthen internal controls, although the material weakness related to segregation of duties remains[406] Tax and NOL Carryforwards - The company did not recognize any current income tax expense or benefit due to a full valuation allowance on its deferred income tax assets for the fiscal years ended June 30, 2022 and 2021[369] - The total deferred income tax assets as of June 30, 2022, amounted to $46.6 million, with a valuation allowance of the same amount, resulting in net deferred income tax assets of $0[372] - As of June 30, 2022, the company has U.S. federal net operating loss (NOL) carryforwards of approximately $145.1 million, with $90.4 million not expiring and $54.7 million beginning to expire from 2031 to 2038[367] Lease Agreements - The Company entered into a new lease agreement for a corporate headquarters in Redwood City, California, with total base rent payments of approximately $2.9 million through September 2027[295] - Future lease payments under the new headquarters lease are projected to total $2.828 million, with the first payment of $149,000 due in fiscal year 2023[297] - Total operating lease liabilities as of June 30, 2022, amounted to $188,000, a reduction of 58.4% from $452,000 in 2021[293] Miscellaneous - The company has an accumulated deficit of $209.2 million as of June 30, 2022[286] - The fair value of cash and cash equivalents approximated their carrying values as of June 30, 2022, and 2021, due to the short maturity of the respective instruments[396] - The company reported that its cash deposits exceeded federal insurance limits for both fiscal years ended June 30, 2022, and 2021, indicating a concentration of credit risk[398]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State or other jurisdicti ...

Table of Contents | Page | | --- | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39683 REZOLUTE, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 27-3440894 (State ...