Registrational study in patients with tumor hyperinsulinism (HI) expected to commence mid-year Designation underscores need for therapies to treat severe hypoglycemia in the oncology setting REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by HI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its i ...

Core Insights - Rezolute, Inc. is a late-stage rare disease company focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism [2] Group 1: Company Overview - Rezolute's antibody therapy, ersodetug, is designed to treat all forms of hyperinsulinism and has demonstrated substantial benefits in clinical trials and real-world applications for congenital and tumor-related hyperinsulinism [2] Group 2: Upcoming Events - Management will participate in several investor conferences, including: - The Citizens JMP Life Sciences Conference on May 7-8, 2025 - H.C. Wainwright BioConnect Investor Conference on May 20, 2025 - Craig-Hallum Institutional Investor Conference on May 28, 2025 - Jefferies Global Healthcare Conference on June 3-5, 2025 - One-on-one investor meetings will be held throughout these conferences [1]

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Core Viewpoint - Rezolute, Inc. has successfully closed an underwritten offering of 24,940,769 shares of common stock at a price of $3.25 per share, raising approximately $96.9 million for research and development, corporate expenses, and working capital needs [1][2]. Group 1: Offering Details - The offering included 4,153,846 shares from the underwriters' option and pre-funded warrants for up to 6,905,385 shares at an offering price of $3.2490 per warrant [1]. - The offering attracted participation from both new and existing investors, including notable firms such as Federated Hermes Kaufmann Funds and Blackstone Multi-Asset Investing [2]. - Guggenheim Securities served as the sole book-running manager, with BTIG, H.C. Wainwright & Co., and Jones as lead managers [3]. Group 2: Private Placement - In addition to the offering, existing investors have committed to purchase up to $4.2 million in shares in a private placement at the same offering price, expected to close around May 7, 2025 [4]. Group 3: Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing therapies for rare diseases, particularly targeting hypoglycemia caused by hyperinsulinism [7]. - The company's antibody therapy, ersodetug, has demonstrated significant benefits in clinical trials for treating congenital and tumor-related hypoglycemia [7].

Core Viewpoint - Rezolute, Inc. has announced an underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $90 million for research and development, general corporate expenses, and working capital needs [1][4]. Group 1: Offering Details - The offering consists of 20,786,923 shares of common stock priced at $3.25 per share and pre-funded warrants to purchase up to 6,905,385 shares at $3.2490 each [1]. - Gross proceeds from the offering are expected to be around $90 million before deducting underwriting discounts and commissions [1]. - The underwriters have a 30-day option to purchase an additional 4,153,846 shares at the offering price [1]. Group 2: Investor Participation - The offering includes participation from both new and existing investors, such as Federated Hermes Kaufmann Funds, Blackstone Multi-Asset Investing, and others [3]. Group 3: Management and Advisors - Guggenheim Securities is the sole book-running manager for the offering, with BTIG, H.C. Wainwright & Co., and Jones acting as lead managers [4]. - Craig-Hallum and Maxim Group LLC are co-managers, while WG Partners LLP serves as the financial advisor [4]. Group 4: Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing therapies for serious rare diseases, particularly targeting hypoglycemia caused by hyperinsulinism [7]. - The company's antibody therapy, ersodetug, has shown significant benefits in clinical trials for treating congenital and tumor-related hyperinsulinism [7].

REDWOOD CITY, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (the "Company or "Rezolute"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced the DMC's recommendation to continue the Phase 3 sunRIZE study as planned in patients with congenital HI, without an increase in the study sample size. "We are thrilled with the DMC's favorable recommendation, which appears to validate our initial ...

Independent Data Monitoring Committee (the "DMC") recommends continuation of sunRIZE trial as planned with no need to increase sample size Enrollment on track and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. sites activated and enrolling patients About Ersodetug Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of HI, the ...

Core Viewpoint - Rezolute, Inc. (RZLT) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, driven by institutional investors adjusting their valuations based on these estimates [4][6]. - Rezolute is projected to earn -$0.93 per share for the fiscal year ending June 2025, reflecting a year-over-year change of 30.1% [8]. Analyst Sentiment and Market Position - Analysts have raised their earnings estimates for Rezolute, with the Zacks Consensus Estimate increasing by 6.1% over the past three months [8]. - The upgrade to Zacks Rank 2 places Rezolute in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Company Overview - Rezolute, Inc. is a late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases with significant unmet needs [1] - The company is particularly dedicated to improving outcomes for individuals suffering from hypoglycemia caused by hyperinsulinism (HI) [3] Leadership Appointment - Erik Harris has been appointed to the Board of Directors of Rezolute, effective immediately [1] - Mr. Harris is currently the Chief Commercial Officer and Executive Vice President at Ultragenyx, bringing over 20 years of biopharmaceutical expertise [1][2] - The CEO of Rezolute, Nevan Charles Elam, expressed enthusiasm about Mr. Harris's appointment, highlighting his experience in rare disease commercialization and strategic vision [2] Product Development - Rezolute's lead product, ersodetug, is an antibody therapy designed to treat all forms of hyperinsulinism and has shown substantial benefits in clinical trials [3] - The company aims to advance ersodetug through clinical development and prepare for potential commercialization [2][3]

Financial Performance - Total current assets decreased from $128,653,000 as of June 30, 2024, to $98,694,000 as of December 31, 2024, a decline of approximately 23.3%[14] - Total assets decreased from $132,737,000 as of June 30, 2024, to $112,007,000 as of December 31, 2024, representing a decrease of about 15.6%[14] - Net loss for the six months ended December 31, 2024, was $31,108,000, compared to a net loss of $28,433,000 for the same period in 2023, reflecting an increase in loss of about 9.4%[16] - The company reported a comprehensive loss of $30,965,000 for the six months ended December 31, 2024, compared to a comprehensive loss of $28,130,000 for the same period in 2023, indicating a worsening of approximately 10.2%[16] - As of December 31, 2024, the company reported an accumulated deficit of $360.6 million and incurred a net loss of $31.1 million for the six months ended December 31, 2024[37] - The company incurred cumulative net losses of $360.6 million since inception and has not generated meaningful revenue to date[175] - The net loss for the six months ended December 31, 2024, was $31.1 million, compared to a net loss of $28.4 million in the same period of 2023, reflecting an increase of $2.7 million[193] Cash and Investments - Cash and cash equivalents decreased from $70,396,000 at the beginning of the period to $8,932,000 at the end of the period, a decline of approximately 87.3%[21] - The company had cash and cash equivalents of $8.9 million, short-term investments in marketable debt securities of $87.6 million, and long-term investments of $8.8 million as of December 31, 2024[37] - Cash and cash equivalents as of December 31, 2024, were $8.9 million, with short-term marketable debt securities of $87.6 million, resulting in total working capital of approximately $88.1 million[175] - Net cash used in investing activities for the six months ended December 31, 2024, amounted to $37.9 million, with total purchases of marketable debt securities reaching $98.7 million[195] - For the six months ended December 31, 2023, net cash provided by investing activities was $20.4 million, primarily from the maturity of marketable debt securities totaling $60.5 million[196] Operating Expenses - Total operating expenses for the six months ended December 31, 2024, were $34,021,000, compared to $31,108,000 for the same period in 2023, an increase of approximately 9.2%[16] - G&A expenses for the three months ended December 31, 2024, increased by $1.3 million (41%) to $4.5 million compared to $3.2 million in 2023, primarily due to increased consulting expenses and compensation[163] - Total G&A expenses for the six months ended December 31, 2024, increased by $1.8 million (26%) to $8.6 million compared to $6.9 million in 2023, mainly due to higher consulting and compensation expenses[170] - R&D expenses for the six months ended December 31, 2024, rose by $1.1 million (5%) to $25.4 million from $24.3 million in 2023, driven by increased costs related to ersodetug and other preclinical activities[168] Capital Raising Activities - The company raised $6,000,000 from the issuance of common stock in a private placement during the six months ended December 31, 2024[19] - The company completed a private placement in July 2024, selling 1.5 million shares of common stock for gross cash proceeds of $6.0 million[38] - The 2024 Underwritten Offering raised gross proceeds of $67.1 million from the issuance of 11,250,000 shares at $4.00 per share and pre-funded warrants for 3,750,000 shares[67][71] - The company executed a securities exchange agreement on March 8, 2024, purchasing 3,000,000 shares of common stock for $5.7 million, which were immediately cancelled[72] - The company has a maximum of $50.0 million remaining for sale under an open market sales agreement with Jefferies LLC as of December 31, 2024[76] Research and Development - The company is focused on developing treatments for hyperinsulinism and diabetic macular edema, with key clinical assets including ersodetug and RZ402[24] - Research and development expenses for the three months ended December 31, 2024, were $12,627,000, compared to $12,039,000 for the same period in 2023, an increase of about 4.9%[16] - The increase in R&D expenses was primarily due to a $2.8 million net increase in ersodetug R&D costs, driven by manufacturing and clinical costs related to the tHI phase 3 study expected to start in Q2 2025[161] - The company has received over 25 unsolicited physician inquiries regarding ersodetug for tumor hypoglycemia, leading to the treatment of nine patients[137] - Currently, four patients with chronic hypoglycemia are receiving ersodetug as part of the Expanded Access Program, with treatment durations ranging from 6 months to over 2 years[136] Clinical Trials and Market Potential - The company is focused on executing two Phase 3 clinical trials for ersodetug, aiming for complete enrollment of ex-U.S. participants in the sunRIZE study[116] - The sunRIZE Phase 3 study is evaluating the safety and efficacy of ersodetug in participants with congenital hyperinsulinism, with topline results expected in Q4 2025[120] - An interim analysis of the primary endpoint for the sunRIZE study is planned for the current quarter, with results to be announced early in the second quarter[122] - The U.S. market for congenital hyperinsulinism is estimated to have over 1,500 individuals who could be immediately addressed by the Company's treatments[124] - The Phase 3 registrational study for tumor hyperinsulinism is set to commence patient enrollment in Q2 2025, with topline results anticipated in the second half of 2026[126] Financial Obligations and Risks - The company has long-term contractual obligations for milestone payments up to $30.0 million to XOMA and $25.0 million to ActiveSite, with $5.0 million expected to be payable to XOMA in the next 12 months[180] - Future commercialization of ersodetug and RZ402 may require additional milestone payments and royalties totaling up to $202.5 million[183] - The company faces risks related to unstable market conditions, which may adversely affect its financial performance and stock price[208] Shareholder Equity and Stock Options - As of December 31, 2024, total shareholders' equity was $99.589 million, a decrease from $113.441 million as of September 30, 2024, reflecting a net loss of $15.730 million during the quarter[58] - The company authorized an increase in common shares from 100 million to 165 million shares as of December 31, 2024[59] - The company has a weighted average remaining lease term of 2.8 years and total future cash payments under operating leases amounting to $2.1 million[47][48] - The intrinsic value of outstanding options as of December 31, 2024, was approximately $19.2 million, while the aggregate intrinsic value of vested stock options was approximately $8.6 million[88] Miscellaneous - The company has not generated any revenue since its inception in March 2010 and does not expect to generate revenue from product candidates for several years[159] - The company did not recognize any income tax benefit due to a full valuation allowance on its deferred income tax assets for the three and six months ended December 31, 2024[100] - The company had no off-balance sheet transactions for the periods covered by this report[201] - There were no changes in internal control over financial reporting that materially affected the company's financial reporting during the period[204]