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].

NEW YORK, April 23, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the pricing of an underwritten offering, priced at-the-market under Nasdaq rules, of an aggregate of 20,786,923 shares of its common stock at an offering price of $3.25 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to ...

Rezolute, Inc. (RZLT) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual investors often ...

REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, announced the appointment of Erik Harris to its Board of Directors, effective immediately. Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings more than 20 years of biopharmaceutical expertise to Rezolute. “We are thrilled to welcom ...

Group 1 - Rezolute is a microcap biopharma based in Redwood City, California, focusing on therapies for hypoglycemia caused by hyperinsulinism [1] - The company is currently in late-stage trials, with data from earlier stages available, making it an interesting investment opportunity [1] - Avisol Capital Partners, the team behind the analysis, consists of medical experts, finance professionals, and techies who invest their own money in the stocks they recommend [1]

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]

Exhibit 99.1 Rezolute Reports Second Quarter Fiscal 2025 Financial Results and Provides Business Update Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and Orphan Drug Designation Open-label arm (infant participants < 1 year old) of the sunRIZE study has been reviewed by a Data Monitoring Committee (DMC); target drug concentrations were safely reached at tested doses and infants are approved for enrollment into the doub ...

Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and Orphan Drug Designation Open-label arm (infant participants < 1 year old) of the sunRIZE study has been reviewed by a Data Monitoring Committee (DMC); target drug concentrations were safely reached at tested doses and infants are approved for enrollment into the double-blind portion of the study REDWOOD CITY, Calif., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Na ...

Core Viewpoint - Rezolute (RZLT) shares have increased by 30.8% over the past six months, contrasting with a 4.1% decline in the industry, primarily due to positive investor sentiment regarding the development of its lead candidate, ersodetug (RZ358) [1] Group 1: Company Overview - Rezolute is a late-stage clinical biotech company focused on improving outcomes for individuals suffering from hypoglycemia caused by hyperinsulinism (HI) [1] - The company is currently evaluating ersodetug in the phase III sunRIZE study for treating patients with congenital HI, an ultra-rare pediatric genetic disorder [2] Group 2: Study Progress and Results - Recent outcomes from the open label arm (OLA) of the phase III sunRIZE study indicated that treatment with ersodetug was generally safe and well-tolerated among eight infants aged three months to one year [4][5] - The Data Monitoring Committee (DMC) approved the enrollment of additional infants into the double-blind portion of the study [5] - Enrollment in the sunRIZE study is expected to be completed by the second quarter of 2025, with top-line data anticipated in the fourth quarter of 2025 [6] Group 3: Regulatory Designations - The FDA granted Breakthrough Therapy designation to ersodetug for treating hypoglycemia due to congenital HI in January 2025 [6] - The FDA removed the partial clinical hold on the phase III sunRIZE study in September 2024 [6] - Rezolute is also developing ersodetug for treating hypoglycemia caused by tumor HI, with enrollment expected to begin in the first half of 2025 [9] Group 4: Future Expectations - Top-line data from the study evaluating ersodetug in patients with tumor HI is expected in the second half of 2026 [9] - The successful development of ersodetug, along with upcoming clinical milestones, is anticipated to sustain the stock's upward momentum in 2025 [10]

Core Viewpoint - Rezolute, Inc. has announced positive outcomes from the Data Monitoring Committee (DMC) review of the open-label arm of the sunRIZE Phase 3 study for ersodetug, indicating safety and allowing enrollment of infants into the double-blind portion of the study [1][3] Group 1: Study Updates - The open-label arm included 8 infant participants aged 3 months to 1 year, who received doses of 5 or 10 mg/kg of ersodetug [2] - The DMC confirmed the safety and pharmacokinetics of ersodetug, validating the chosen dose regimen and allowing for the continuation of the study [7] - Enrollment completion for the sunRIZE study is expected in Q2 2025, with topline results anticipated in Q4 2025, pending the outcomes of an upcoming interim analysis [1][3] Group 2: Interim Analysis - An interim analysis will assess the adequacy of the sample size for the primary endpoint and may recommend adjustments, including a potential increase in sample size by 33% [4][5] - The DMC will announce the conclusions of the interim analysis early in Q2 2025, with three possible outcomes: stop the study for futility, continue as is, or increase the sample size [4] Group 3: Company Background and Product Information - Rezolute is focused on developing therapies for rare diseases, particularly congenital hyperinsulinism, which causes recurrent hypoglycemia in children [8][11] - Ersodetug is a fully human monoclonal antibody designed to counteract insulin receptor over-activation, potentially effective for various forms of hyperinsulinism [9][11] - The sunRIZE study is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ersodetug in patients aged 3 months to 45 years [10]