Core Insights - Rezolute, Inc. announced positive topline results from the Phase 2 clinical study of RZ402 for diabetic macular edema (DME), demonstrating a good safety profile and significant reduction in central subfield thickness (CST) [1][5][9] - The study indicates the potential for RZ402 to serve as a first-line, non-invasive oral therapy for DME, which could alter long-term patient outcomes [2][3] Study Results - The Phase 2 study enrolled 94 participants in a randomized, double-masked, placebo-controlled design, evaluating RZ402 as a monotherapy over a 12-week period [2][6] - RZ402 showed a significant improvement in CST across all dosage levels compared to placebo, with a maximum reduction of approximately 50 microns (p=0.02) [6][9] - The 200 mg dose of RZ402 yielded the most substantial response, with over 20% of participants experiencing clinically significant improvements [6][11] Safety Profile - RZ402 was reported to be safe and well-tolerated, with adverse events generally mild and comparable to placebo [11] - No ocular adverse effects typically associated with intravitreal injections were observed, and safety assessments including ECGs and vital signs were unremarkable [11] Future Plans - The company plans to present further findings and data at an upcoming medical conference [7] - A virtual investor event is scheduled to discuss these topline results, indicating ongoing engagement with stakeholders [8] About DME and RZ402 - DME is a severe complication of diabetic retinopathy characterized by retinal swelling, and current treatments involve invasive anti-VEGF injections [8][9] - RZ402 is an oral, small molecule plasma kallikrein inhibitor designed to block bradykinin production, potentially reducing vascular leakage and inflammation associated with DME [9]

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, 2024 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 ...

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 ...

Part I [Business](index=6&type=section&id=Item%201.%20Business) Rezolute, Inc. is a clinical-stage biopharmaceutical company developing therapies for metabolic diseases, with lead assets RZ358 and RZ402 in clinical trials [Summary of Clinical Assets](index=6&type=section&id=Summary%20of%20Clinical%20Assets) The company's pipeline is led by RZ358 for congenital hyperinsulinism, with a pivotal Phase 3 study planned, and RZ402 for diabetic macular edema, currently in Phase 2 - **RZ358**, for congenital hyperinsulinism (HI), is preparing to initiate a pivotal **Phase 3 study** (sunRIZE) outside the U.S. in **Q4 2023**, with topline results expected in the **first half of 2025**[17](index=17&type=chunk)[19](index=19&type=chunk) - The **FDA** has imposed an **age restriction (12 years and older)** and **dose level restrictions** on RZ358 clinical studies in the U.S., making it **infeasible** to include the U.S. in the upcoming Phase 3 study[20](index=20&type=chunk) - **RZ402**, an oral therapy for diabetic macular edema (DME), is in a **Phase 2 study**. Enrollment is expected to complete in **2023**, with topline results anticipated in **Q1 2024**[24](index=24&type=chunk)[26](index=26&type=chunk) [Intellectual Property](index=9&type=section&id=Intellectual%20Property) The company relies on its intellectual property, holding exclusive worldwide licenses for RZ358 and RZ402 with patents extending to 2043 - The company holds a worldwide, exclusive license from XOMA for patents covering the **RZ358** molecule, which expire between **2030 and 2036**[29](index=29&type=chunk) - Rezolute holds a worldwide, exclusive license from ActiveSite for patents covering the **RZ402** molecule, with these patents expected to expire between **2040 and 2043**[30](index=30&type=chunk) [Competition](index=11&type=section&id=Competition) Rezolute faces competition from other pharmaceutical and biotechnology companies developing therapies for both HI and DME - Competitors developing therapies for HI include **Eiger Biopharmaceuticals**, **Hanmi Pharmaceuticals**, and **Zealand Pharma**[31](index=31&type=chunk) - Competitors developing therapies for DME include **Curacle**, **KalVista**, **Ocuphire Pharma**, **Oxurion**, and **Verseon**[32](index=32&type=chunk) [Research and Development](index=11&type=section&id=Research%20and%20Development) Research and development expenses significantly increased in fiscal year 2023 compared to 2022 Research and Development Expenses (Fiscal Years 2023 vs. 2022) | Fiscal Year Ended June 30 | R&D Expenses (in millions) | | :--- | :--- | | 2023 | $43.8 | | 2022 | $32.5 | [Human Capital Management](index=11&type=section&id=Human%20Capital%20Management) As of June 30, 2023, Rezolute had 51 employees, with a focus on R&D, diversity, talent retention, and ethical conduct - As of **June 30, 2023**, the company had **51 full-time employees**, with **38** engaged in research and development activities[36](index=36&type=chunk) - The company adopted an **equity and inclusion policy** on **May 30, 2023**, to further its commitment to diversity[37](index=37&type=chunk) - An amended and restated **Code of Business Conduct and Ethics** was adopted on **May 30, 2023**, to improve readability and clarify areas such as compliance, conflicts of interest, and insider trading[39](index=39&type=chunk) [Risk Factors](index=13&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks related to product development, business operations, intellectual property, and its common stock, including FDA holds and financial losses - The company's lead product candidate, **RZ358**, is under a **clinical hold in the U.S.** due to FDA-imposed restrictions, which may delay or prevent its development and commercialization in this key market[48](index=48&type=chunk)[49](index=49&type=chunk) - The company has a history of **net losses**, with an accumulated deficit of **$261.0 million** as of **June 30, 2023**, and will require substantial additional capital to fund operations[86](index=86&type=chunk) - The company's ability to use a significant portion of its federal **net operating loss (NOL) carryforwards** of approximately **$153.2 million** is restricted due to past ownership changes under IRC Section 382[92](index=92&type=chunk) - The company's common stock may be **delisted from the Nasdaq Capital Market** if it fails to maintain the minimum **$1.00 closing bid price** or other continued listing standards[123](index=123&type=chunk)[124](index=124&type=chunk) [Properties](index=41&type=section&id=Item%202.%20Properties) The company leases its headquarters in Redwood City, CA, and office space in Bend, OR, which are deemed sufficient for current needs Leased Properties | Location | Size (sq. ft.) | Monthly Rent (approx.) | Lease Expiration | | :--- | :--- | :--- | :--- | | Redwood City, CA (HQ) | 9,300 | $53,000 (avg. remaining) | October 2027 | | Bend, OR | 5,000 | $8,400 | February 2024 | [Legal Proceedings](index=41&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to materially affect its financial condition or operations - As of **June 30, 2023**, there were no pending or threatened lawsuits that could reasonably be expected to have a material effect on the Company's results of operations[351](index=351&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=41&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Rezolute's common stock trades on Nasdaq, with 274 holders of record as of September 8, 2023, and no plans for future cash dividends - The company's common stock trades on Nasdaq under the symbol "**RZLT**"[139](index=139&type=chunk) - As of **September 8, 2023**, there were **274 holders of record** of the company's common stock[140](index=140&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[141](index=141&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Result%20of%20Operations) This section details the company's financial performance, including key objectives, FDA restrictions, increased net loss in FY2023, and a cash runway through Q3 2025 [Executive Summary](index=43&type=section&id=Executive%20Summary) Key objectives include initiating the RZ358 Phase 3 study and announcing RZ402 Phase 2 results, despite FDA restrictions on RZ358 in the U.S., while diversifying cash investments - Key objectives are initiating the **RZ358 Phase 3 study** and announcing **RZ402 Phase 2 topline results in Q1 2024**[148](index=148&type=chunk) - The **FDA** affirmed its decision to impose "**New Restrictions**" on RZ358 in the U.S., including an **age restriction of 12 years and above** and re-imposing a previous exposure cap, making U.S. inclusion in the Phase 3 study infeasible[154](index=154&type=chunk)[155](index=155&type=chunk) - In **January 2023**, the company invested **$115.0 million** of its cash into a portfolio of marketable debt securities to achieve higher returns[158](index=158&type=chunk) [Results of Operations](index=51&type=section&id=Results%20of%20Operations) Net loss increased to $51.8 million in FY2023, driven by higher R&D and G&A expenses, partially offset by increased interest income from investments Consolidated Statements of Operations (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $ 43,813 | $ 32,486 | | General and administrative | 12,177 | 9,357 | | **Total operating expenses** | **55,990** | **41,843** | | **Operating loss** | **(55,990)** | **(41,843)** | | Interest and other income | 4,208 | 80 | | **Net loss** | **$ (51,787)** | **$ (41,060)** | - **R&D expenses increased by $11.3 million (35%)**, primarily due to a **$5.3 million increase in R&D compensation and benefits**, and a **$4.3 million increase in spending on clinical programs** (RZ358 and RZ402)[183](index=183&type=chunk)[184](index=184&type=chunk) - The **RZ402 program costs increased by $3.2 million**, mainly due to a **$3.0 million milestone payment** triggered by the first patient dosing in the Phase 2 study in February 2023[188](index=188&type=chunk) - **Interest and other income increased to $4.2 million from $0.1 million**, primarily due to the investment of **$115.0 million** in marketable debt securities starting in January 2023[190](index=190&type=chunk) [Liquidity and Capital Resources](index=54&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had $118.3 million in cash and investments, providing a runway through Q3 2025, with significant future milestone payment obligations Liquidity Position as of June 30, 2023 | Metric | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents | $16.0 | | Investments in marketable debt securities | $102.3 | | **Total Cash & Investments** | **$118.3** | | Working Capital | $99.7 | | Accumulated Deficit | $261.0 | - The company believes it has adequate capital to fund planned activities at least through the **third quarter of calendar year 2025**[200](index=200&type=chunk) - Significant long-term obligations include potential clinical and regulatory milestone payments of up to **$35.0 million to XOMA** and **$25.0 million to ActiveSite**[201](index=201&type=chunk) - A milestone payment of **$5.0 million to XOMA** is expected to be due within the next twelve months upon the first patient dosing in the **RZ358 Phase 3 study**[199](index=199&type=chunk)[206](index=206&type=chunk) [Financial Statements and Supplementary Data](index=61&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for FY2023 and FY2022, with an unqualified auditor's opinion, detailing key financial positions and performance Consolidated Balance Sheet Highlights (in thousands) | | June 30, 2023 | June 30, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 16,036 | $ 150,410 | | Investments in marketable debt securities | 102,330 | — | | **Total Assets** | **$ 123,721** | **$ 152,420** | | Total Liabilities | 7,549 | 2,949 | | **Total Shareholders' Equity** | **116,172** | **149,471** | Consolidated Statements of Operations Highlights (in thousands) | | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Total operating expenses | $ 55,990 | $ 41,843 | | Operating loss | (55,990) | (41,843) | | **Net loss** | **$ (51,787)** | **$ (41,060)** | | **Comprehensive loss** | **$ (52,138)** | **$ (41,060)** | [Controls and Procedures](index=101&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2023, with a previously identified material weakness successfully remediated - The CEO concluded that the company's **disclosure controls and procedures were effective** as of **June 30, 2023**[383](index=383&type=chunk) - Management determined that the company's **internal control over financial reporting was effective** as of **June 30, 2023**[387](index=387&type=chunk) - A previously identified **material weakness** related to inadequate segregation of duties was **successfully remediated** as of **June 30, 2023**[388](index=388&type=chunk)[391](index=391&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=103&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section provides biographical information for directors and executive officers, details Board committee composition, and highlights the adoption of an amended Code of Business Conduct and Ethics - The Board of Directors has three standing committees: **Audit**, **Compensation**, and **Nominating and Corporate Governance**[413](index=413&type=chunk) - The **Audit Committee** is composed of independent directors **Gil Labrucherie (chair)**, Philippe Fauchet, and Dr. Wladimir Hogenhuis, with Mr. Labrucherie and Dr. Hogenhuis qualified as "audit committee financial experts"[415](index=415&type=chunk) - The company adopted an amended and restated **Code of Business Conduct and Ethics** on **May 30, 2023**[412](index=412&type=chunk) [Executive Compensation](index=113&type=section&id=Item%2011.%20Executive%20Compensation) This section details compensation for Named Executive Officers and directors for FY2023 and FY2022, including salaries, bonuses, stock options, and employment agreement terms Summary Compensation for Named Executive Officers (FY 2023) | Name and Position | Salary | Bonus | All Other Compensation | Total | | :--- | :--- | :--- | :--- | :--- | | Nevan Charles Elam (CEO) | $534,112 | $416,068 | $23,466 | $973,646 | | Brian Roberts, M.D. (CMO) | $457,809 | $237,753 | $43,296 | $738,858 | - Employment agreements for NEOs include **severance benefits** for termination without cause or resignation for good reason, with **enhanced benefits in the event of a change of control**[431](index=431&type=chunk)[432](index=432&type=chunk)[434](index=434&type=chunk) - Non-employee director compensation consists of annual cash retainers for board service (**$45,000**) and additional fees for committee membership and chair roles[440](index=440&type=chunk)[450](index=450&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=120&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details significant beneficial ownership, including major institutional holders and management's collective stake, along with shares available under equity compensation plans Beneficial Ownership Greater Than 5% (as of Sept 8, 2023) | Name of Beneficial Owner | Percent of Class | | :--- | :--- | | Entities associated with Federated Hermes, Inc. | 19.9 % | | Handok, Inc. | 16.1 % | | First Manhattan Co. LLC | 9.8 % | | Stonepine Capital, L.P. | 8.2 % | - Directors and executive officers as a group beneficially owned **8,052,086 shares**, representing **20.8% of the class**[454](index=454&type=chunk)[458](index=458&type=chunk) - As of **June 30, 2023**, a total of **2,812 thousand shares** were available for future issuance under the company's equity compensation plans[457](index=457&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=126&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The Audit Committee reviews related party transactions, the Board determined four directors are independent, and significant related party transactions include an exclusive license with Handok, Inc - The **Audit Committee reviews and approves all related party transactions** to prevent conflicts of interest[460](index=460&type=chunk) - Four directors were determined to be **independent**: Mr. Labrucherie, Mr. Fauchet, Dr. Hogenhuis, and Dr. Kreher[461](index=461&type=chunk) - The company has an **exclusive license agreement with Handok, Inc.**, an entity affiliated with director Young-Jin Kim, for the commercialization of RZ358 and RZ402 in South Korea[463](index=463&type=chunk) - **Handok, Inc. and its affiliates purchased an aggregate of $17.3 million in company stock** through a registered direct offering and a private placement in FY2022 and July 2022[464](index=464&type=chunk)[465](index=465&type=chunk) [Principal Accounting Fees and Services](index=127&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section discloses fees billed by the independent auditor, Plante & Moran, PLLC, for fiscal years 2023 and 2022, all pre-approved by the Audit Committee Principal Accountant Fees (in thousands) | Fee Category | 2023 | 2022 | | :--- | :--- | :--- | | Audit fees | $190.0 | $259.0 | | Tax fees | $36.6 | $47.2 | | **Total** | **$226.6** | **$306.2** | Part IV [Exhibits and Financial Statement Schedules](index=129&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including material contracts and certifications, with financial statement schedules omitted as not applicable - The report includes a list of all exhibits filed, such as material contracts and corporate governance documents[474](index=474&type=chunk)[475](index=475&type=chunk) - All financial statement schedules are omitted because they are not applicable, immaterial, or the required information is already presented in the financial statements[472](index=472&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 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]