Highest-materiality recent filing
Rezolute reports positive interim Phase 3 upLIFT data: 6 of 8 patients met primary endpoint
8 patients enrolled (50% of planned 16); 6 responders with ≥50% reduction in IV glucose, all 6 achieved complete discontinuation.
Rezolute Q3 FY2026 net loss $16.2M, cash $120.3M; Phase 3 sunRIZE shows >50% hypoglycemia reduction
Net loss $16.2M vs $18.9M YoY; R&D expense $11.4M, down from $15.3M.
Rezolute sunRIZE Phase 3 misses primary endpoint; CGM analyses show nominal hypoglycemia reduction
Primary endpoint (hypoglycemia events by SMBG) not met; secondary CGM endpoint not statistically significant at Week 24/EOT.
Rezolute provides FDA meeting update after Phase 3 HI trial missed primary endpoint
sunRIZE Phase 3 ersodetug trial missed primary endpoint (SMBG hypoglycemia reduction); FDA acknowledged behavioral confounders.
Rezolute Q2 net loss $22.8M; Phase 3 congenital HI study misses primary endpoint
Net loss $22.8M vs $15.7M YoY; R&D $14.3M, G&A $9.9M; cash $132.9M down from $167.9M.
Phase 3 sunRIZE in congenital HI missed primary (hypoglycemia events) and key secondary endpoints; company cites strong placebo response and monitoring effect.
Rezolute annual meeting: directors elected, equity plan approved, say-on-pay passes with 32% against
All 7 director nominees elected: Kim 52.98M for, Kreher 45.49M for (13.88M withheld), Hogenhuis 45.75M for.
Rezolute hosts investor event on Ersodetug program; no specific data disclosed in filing
Company held investor event on November 10, 2025, to update Ersodetug development program.
Rezolute reports Q1 FY2026 net loss $18.2M; Phase 3 sunRIZE topline due Dec 2025
Cash & marketable securities $152.2M as of Sep 30, 2025, down from $167.9M on Jun 30.
Rezolute amends exec employment agreements for 280G gross-up; terminates unused Jefferies ATM
CEO Nevan Elam, CMO Brian Roberts, CFO Daron Evans, CCO Sunil Karnawat get full gross-up for 280G excise tax on change-of-control payments.
Rezolute reports FY2025 net loss $74.4M; sunRIZE topline Dec 2025, FDA streamlines tumor HI trial
Net loss of $24.4M for Q4 FY2025, $74.4M full year; cash $167.9M as of June 30, 2025 (up from $127.1M).
Rezolute gains FDA alignment on streamlined Phase 3 trial design for ersodetug in tumor HI
FDA agreed to remove double-blind placebo-controlled requirement; study now open-label, single-arm.
Rezolute appoints Sunil Karnawat as CCO; grants 275K inducement options
Sunil Karnawat appointed Chief Commercial Officer effective Aug 18, 2025; brings 25+ years experience including four ultra-rare disease launches at Ultragenyx.
Rezolute fully enrolls Phase 3 sunRIZE study of ersodetug; topline data expected by end of 2025
63 participants enrolled (8 open-label infants, 55 double-blind); DMC recommended continuing with original sample size after interim analysis.
Rezolute appoints Erik Harris to Compensation Committee, effective July 1, 2025
Erik Harris, appointed to Board on March 25, 2025, added to Compensation Committee effective July 1, 2025.
Rezolute closes $4.2M private placement with insiders at $3.25/share
Issued 1,295,383 shares for aggregate proceeds of $4,209,994.75 to insiders on June 13, 2025.
Rezolute Q3 net loss $18.9M; sunRIZE enrollment on track, BTD for ersodetug
Cash $88.4M at March 31, 2025, down from $127.1M at June 30, 2024.
Rezolute closes $96.9M equity offering at $3.25/share
Aggregate of 24,940,769 common shares at $3.25 plus 6,905,385 pre-funded warrants at $3.2490 each.
Independent DMC recommends continuation of sunRIZE study as planned; no need to increase sample size.
Priced underwritten offering of 20.8M shares and 6.9M pre-funded warrants for gross proceeds of ~$90M; net proceeds ~$84.2M.
Rezolute appoints Erik Harris to board of directors effective March 25, 2025
Erik Harris elected to board effective March 25, 2025; determined independent under Nasdaq rules.
Rezolute reports Q2 net loss $15.7M; ersodetug gets Breakthrough Therapy, Orphan Drug status
Cash & equivalents $105.3M at Dec 31, 2024 vs $127.1M at June 30, 2024.
Rezolute DMC clears ersodetug open-label arm in infants; interim analysis expected Q1 2025
DMC reviewed 8 infants (3mo-1yr) on 5/10 mg/kg bi-weekly/monthly: safe, target concentrations reached.
Rezolute shares patient testimonial with favorable results for ersodetug in Phase 2 study
Company released a pre-recorded video detailing a patient's experience in the Phase 2 trial of investigational drug ersodetug.
FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for hypoglycemia due to congenital hyperinsulinism.
Authorized common stock increased from 100M to 165M shares via Certificate of Amendment filed Dec 6, 2024.
Rezolute Q1 FY2025 net loss $15.4M; cash $117.8M; Phase 3 on track
Net loss $15.4M vs $14.5M YoY; R&D $12.8M, G&A $4.2M.
Rezolute reports Q4 FY2024 net loss of $23M; FDA lifts partial clinical hold on ersodetug
Q4 net loss $23.0M vs $12.7M prior year; full year net loss $68.5M vs $51.8M.
FDA lifts partial clinical holds on Rezolute's RZ358 for congenital hyperinsulinism
FDA removed partial clinical holds on RZ358 (ersodetug) for hypoglycemia in congenital HI; U.S. enrollment in global Phase 3 sunRIZE study now permitted.
Rezolute receives FDA IND clearance for Phase 3 study of RZ358 in tumor hyperinsulinism
FDA cleared IND for RZ358 (ersodetug) Phase 3 registrational trial treating hypoglycemia due to tumor HI.
Rezolute releases Phase 2 topline results for RZ402 in DME; no specifics in filing
Topline results from Phase 2 study of RZ402 in diabetic macular edema (DME) disclosed via website and SEC filing on June 28, 2024.
Rezolute raises ~$67M through public offering and concurrent private placement
Underwriters exercised over-allotment option for 1,786,589 shares at $4.00 each.
Rezolute prices $60M public offering of 11.25M shares and pre-funded warrants at $4.00/share
Offering includes 11,250,000 shares of common stock at $4.00/share and pre-funded warrants for 3,750,000 shares at $3.999 each.
Rezolute reports positive Phase 2 results for RZ402 in DME; CST reduced up to ~50 microns
Phase 2 study of 94 DME patients met primary endpoints: CST reduction (p=0.02) and good safety profile.
Rezolute stockholders approve all proposals at 2024 annual meeting
All six director nominees elected with >26.8M votes each: Kim, Elam, Fauchet, Labrucherie, Hogenhuis, Kreher.
Net loss $17.1M for Q3 FY2024 vs $15.7M YoY; cash and equivalents $81.6M (down from $118.4M in June 2023).
Rezolute to present Phase 2 RIZE overnight hypoglycemia data at PES Annual Meeting
Dr. Paul Thornton will present poster analyzing overnight hypoglycemia in congenital HI patients on May 4, 2024 at PES meeting.
Rezolute exchanges 3M common shares for pre-funded warrants; reduces outstanding by 3M shares
Exchanged 3,000,000 shares with certain stockholders for pre-funded warrants exercisable at $0.001/share.
Rezolute validates RZ358 for NICTH, doubling addressable tumor HI patient population
Preclinical study shows RZ358 blunts IGF-2 and insulin-mediated signaling at clinically relevant levels.
Rezolute regains Nasdaq minimum bid price compliance
On Feb 21, 2024, Rezolute received Nasdaq notice of regained compliance with $1.00 Minimum Bid Price requirement.
Rezolute reports Q2 FY2024 net loss $13.9M; initiates Phase 3 for RZ358 in cHI
Net loss of $13.9M for Q2 FY2024, compared to $13.6M same period prior year.
Rezolute appoints Daron Evans as CFO; receives UK Innovation Passport for RZ358
Daron Evans appointed CFO, effective Jan 23, 2024; base salary $275,000, target bonus 50%.
Rezolute completes Phase 2 DME enrollment, initiates Phase 3 for congenital hyperinsulinism
Phase 2 study of oral RZ402 for diabetic macular edema enrolled ~95 participants; topline data expected mid-Q2 2024.
Rezolute receives Nasdaq delisting notice for bid price below $1.00; has until May 20, 2024 to cure
Nasdaq notice on Nov 21, 2023: closing bid below $1.00 for 30 consecutive trading days.
Rezolute Q1 FY2024 net loss $14.5M; RZ358 Phase 3 start planned before year-end
Net loss of $14.5M for Q1 FY2024 vs $9.8M in same period last year.
Rezolute receives EMA PRIME eligibility for RZ358 in congenital hyperinsulinism
EMA grants PRIME eligibility to RZ358 for congenital HI, citing unmet medical need and positive Phase 2b data.
Rezolute reports RZ358 resolves hypoglycemia in tumor-mediated hyperinsulinism patient
RZ358 administered on compassionate-use basis to patient with refractory hypoglycemia due to metastatic insulin-secreting cervical cancer.
Rezolute reports FY2023 net loss of $51.8M; Phase 3 for RZ358 to start Q4 2023
Cash and equivalents $16.0M, marketable securities $102.3M as of June 30, 2023.
Phase 3 sunRIZE study of RZ358 planned in Europe/ex-US starting Q4 2023; topline results expected 1H 2025.
Patient with metastatic insulinoma and intractable hypoglycemia received RZ358 under compassionate use IND.
On March 25, 2025, the Board of Directors (the “Board”) of Rezolute, Inc. (the “Company”) upon the recommendation of the Company’s nominating and corporate governance committee elected Erik Harris to the Board, effective March 25, 2025
On January 23, 2024, the Company’s Board of Directors approved the appointment of Mr. Evans, 50 years of age, to serve as the Company’s Chief Financial Officer.
Max materiality 0.85 · Median 0.68 · Most common event other_material