Rezolute, Inc.
Business
Rezolute, Inc. is a late-stage rare disease company focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism. It develops ersodetug, an intravenously administered human monoclonal antibody that allosterically binds the insulin receptor to down-modulate insulin binding, signaling and action, and operates an expanded access program for severely affected patients. The company’s operations center on clinical development programs, regulatory interactions and intellectual property management, including pivotal Phase 3 studies for congenital and tumor hyperinsulinism. Rezolute conducts global clinical trials and makes investigational therapy available through clinical sites, expanded access requests and regulatory channels across the U.S., EU, UK and other countries.
Summary from filing dated 2025-09-17
Financials
Consolidated Statement of Income
| Concept | Trend | FY 2025 2025-06-30 | FY 2024 2024-06-30 | FY 2023 2023-06-30 | FY 2022 2022-06-30 | FY 2021 2021-06-30 |
|---|---|---|---|---|---|---|
| Research and development | 62 | 56 | 44 | 32 | 15 | |
| General and administrative | 18 | 15 | 12 | 9 | 8 | |
| Total operating expenses | 80 | 70 | 56 | 42 | 23 | |
| Operating loss | −80 | −70 | −56 | −42 | −23 | |
| Interest and other income, net | 5 | 5 | 4 | 80,000 | 63,000 | |
| Total non-operating income (expense), net | 5 | 2 | 4 | 783,000 | 2 | |
| Net loss | −74 | −68 | −52 | −41 | −21 | |
| Net unrealized gain on marketable debt securities | 72,000 | 272,000 | −351,000 | — | — | |
| Comprehensive loss | −74 | −68 | −52 | −41 | — | |
| Net loss per common share - basic (in dollars per share) | −0.98 | −1.33 | −1.01 | −2.26 | −2.72 | |
| Net loss per common share - diluted (in dollars per share) | −0.98 | −1.33 | −1.01 | −2.32 | −2.72 | |
| Weighted average number of common shares outstanding - basic (in shares) | 76 | 51 | 51 | 18 | 8 | |
| Weighted average number of common shares outstanding - diluted (in shares) | 76 | 51 | 51 | 19 | 8 |
Consolidated Balance Sheet
| Concept | Trend | FY 2025 2025-06-30 | FY 2024 2024-06-30 | FY 2023 2023-06-30 | FY 2022 2022-06-30 | FY 2021 2021-06-30 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents | 94 | 70 | 16 | 150 | 41 | |
| Investments in marketable debt securities | 74 | 56 | 86 | — | — | |
| Prepaid expenses and other | 3 | 2 | 3 | 2 | 946,000 | |
| Total current assets | 171 | 129 | 105 | 152 | 42 | |
| Deposits and other | 3 | 2 | 148,000 | 148,000 | 191,000 | |
| Right-of-use assets | 1 | 2 | 2 | 152,000 | 396,000 | |
| Property and equipment, net | 72,000 | 103,000 | 139,000 | 16,000 | 29,000 | |
| Investments in marketable debt securities | — | 263,000 | 16 | — | — | |
| Total assets | 175 | 133 | 124 | 152 | 43 | |
| Accounts payable | 6 | 5 | 3 | 1 | 1 | |
| Accrued clinical and other | 3 | 2 | 507,000 | 1 | — | |
| Compensation and benefits | 2 | 2 | 883,000 | — | 77,000 | |
| Current portion of operating lease liabilities | 632,000 | 568,000 | 541,000 | 108,000 | 265,000 | |
| Total current liabilities | 12 | 10 | 5 | 2 | 2 | |
| Operating lease liabilities, net of current portion | 983,000 | 2 | 2 | 80,000 | 187,000 | |
| Embedded derivative liability | 468,000 | 468,000 | 412,000 | 407,000 | 387,000 | |
| Total liabilities | 13 | 12 | 8 | 3 | 17 | |
| Commitments and contingencies (Notes 5, 10 and 11) | — | — | — | — | — | |
| Preferred stock, $0.001 par value; 400,000 shares authorized; no shares issued | — | — | — | — | — | |
| Common stock, $0.001 par value; 165,000,000 and 100,000,000 shares authorized; issued and outstanding 86,995,985 and 53,245,824 shares as of June 30, 2025 and 2024, respectively | 87,000 | 53,000 | 37,000 | 34,000 | 8,000 | |
| Additional paid-in capital | 566 | 450 | 377 | 359 | 194 | |
| Accumulated other comprehensive loss | −7,000 | −79,000 | −351,000 | — | — | |
| Accumulated deficit | −404 | −329 | −261 | −209 | −168 | |
| Total shareholders' equity | 162 | 121 | 116 | 149 | 26 | |
| Total liabilities and shareholders' equity | 175 | 133 | 124 | 152 | 43 |
Consolidated Statement of Cash Flows
| Concept | Trend | FY 2025 2025-06-30 | FY 2024 2024-06-30 | FY 2023 2023-06-30 | FY 2022 2022-06-30 | FY 2021 2021-06-30 |
|---|---|---|---|---|---|---|
| Net loss | −74 | −68 | −52 | −41 | −21 | |
| Share-based compensation expense | 7 | 7 | 7 | 4 | 4 | |
| Non-cash lease expense | 532,000 | 526,000 | 352,000 | 243,000 | 290,000 | |
| Accretion of discounts and amortization of premiums on marketable debt securities, net | −2 | −3 | −1 | — | — | |
| Depreciation expense | 31,000 | 36,000 | 30,000 | 13,000 | 13,000 | |
| Increase in prepaid expenses, deposits, and other assets | −2 | −129,000 | −1 | −860,000 | −387,000 | |
| Increase in accounts payable | 1 | 1 | 2 | −11,000 | 142,000 | |
| Increase in accrued liabilities | 721,000 | 2 | 205,000 | 229,000 | — | |
| Net Cash Used in Operating Activities | −69 | −57 | −44 | −40 | −20 | |
| Purchase of marketable debt securities | −128 | −66 | −107 | — | — | |
| Proceeds from maturities of marketable debt securities | 114 | 115 | 6 | — | — | |
| Net Cash Provided by (Used in) Investing Activities | −15 | 49 | −101 | — | 0 | |
| Proceeds from exercise of stock options | 893,000 | 234,000 | — | — | — | |
| Net cash payment pursuant to Exchange Agreement | — | −3,000 | — | — | — | |
| Payment of offering costs | −1 | −315,000 | — | — | −4 | |
| Net Cash Provided by Financing Activities | 107 | 63 | 12 | 149 | 52 | |
| Net increase in cash and cash equivalents | 24 | 54 | −134 | 109 | 31 | |
| Cash paid for amounts included in the measurement of operating lease liabilities | 748,000 | 728,000 | 215,000 | 254,000 | 299,000 | |
| Operating lease liabilities incurred in exchange for right-of-use-assets | — | 352,000 | 2 | — | 302,000 | |
| Acquisition of treasury shares in exchange for issuing pre-funded warrant liability | — | 6 | — | — | — | |
| Receivable from exercise of stock options | 503,000 | 12,000 | — | — | — | |
| Payable for offering costs charged to additional paid-in capital | 35,000 | 548,000 | — | — | — |