Rezolute Bio

Rezolute Bio

Develops monoclonal antibodies for rare diseases

Overview

Rezolute Bio develops therapies for rare diseases, aiming to address unmet needs in both pediatric and adult patients. Its lead candidate, RZ358, is a human monoclonal antibody in late-stage trials for congenital hyperinsulinism and works by binding to and inhibiting insulin to reduce hypoglycemic events. The company also pursues RZ402, an oral plasma kallikrein inhibitor for diabetic macular edema. Its goal is to bring approved therapies to patients by advancing late-stage programs toward commercialization and building a portfolio focused on rare diseases.

About Rezolute Bio

Simplify's Rating
Why Rezolute Bio is rated
C+
Rated C on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

IPO

Headquarters

Louisville, Kentucky

Founded

2010

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Simplify's Take

What believers are saying

  • FDA's March 24, 2026 meeting encouraged a full sunRIZE and OLE data submission.
  • upLIFT was 50% enrolled by June 2, 2026, with topline data due H2 2026.
  • Rezolute posted $120.3 million cash and investments on March 31, 2026.

What critics are saying

  • sunRIZE missed primary and key secondary endpoints in December 2025, damaging BLA odds.
  • Rezolute cut 29 jobs in December 2025 and spent $1.5 million severance.
  • If FDA rejects sunRIZE, ersodetug loses congenital HI approval and the company becomes financing-dependent.

What makes Rezolute Bio unique

  • Ersodetug targets the insulin receptor downstream, spanning congenital and tumor hyperinsulinism.
  • FDA streamlined upLIFT in September 2025, shrinking registration risk and trial complexity.
  • Rezolute is building launch infrastructure in 2026, hiring commercial and supply-chain leaders.

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Funding

Total Funding

$469.1M

Above

Industry Average

Funded Over

15 Rounds

Post IPO Equity funding comparison data is currently unavailable. We're working to provide this information soon!
Post IPO Equity Funding Comparison
Coming Soon

Benefits

Health Insurance

Disability Insurance

Life Insurance

Paid Holidays

Paid Vacation

401(k) Plan Match

Gym Membership

Stock Price

Growth & Insights and Company News

Headcount

6 month growth

1%

1 year growth

4%

2 year growth

2%
Africa Business Watch
Jul 21st, 2026
Rezolute to participate in the BTIG Virtual Biotechnology Conference.

Rezolute to participate in the BTIG Virtual Biotechnology Conference. REDWOOD CITY, Calif., July 21, 2026 (GLOBE NEWSWIRE) - Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today announced that management will participate in the BTIG Virtual Biotechnology Conference, taking place July 28-29, 2026. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their BTIG representative. About Rezolute, Inc. Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI). The Company's antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com. Rezolute Contacts: Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

The Manila Times
Apr 21st, 2026
Rezolute to present results from its Phase 3 sunRIZE study in congenital hyperinsulinism at the Pediatric Endocrine Society (PES) Annual Meeting.

Rezolute to present results from its Phase 3 sunRIZE study in congenital hyperinsulinism at the Pediatric Endocrine Society (PES) Annual Meeting. By GlobeNewswire April 21, 2026 Oral presentation will include previously announced topline results as well as pre-specified and post-hoc data updates REDWOOD CITY, Calif., April 21, 2026 (GLOBE NEWSWIRE) - Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced that results from the Phase 3 sunRIZE study of ersodetug in congenital HI were accepted for an oral presentation at the Pediatric Endocrine Society (PES) Annual Meeting being held April 30-May 3, 2026, in San Francisco, CA. In addition to the previously reported topline results, the presentation will also include results from pre-specified and post-hoc sunRIZE analyses, which the Company believes continue to demonstrate target engagement and the therapeutic benefit of ersodetug. Presentation Title: Top-Line Results From a Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (sunRIZE) Format: Oral presentation Presenter: Diva D. De León-Crutchlow, MD, MSCE Session Date and Time: Friday, May 1, 2026, from 8:15 a.m. - 9:15 a.m. PT Session Title: Oral Abstracts #1 About sunRIZE The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive ersodetug. The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment. 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 hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI. About Rezolute, Inc. Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company's antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit www.rezolutebio.com. Forward-Looking Statements This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating hypoglycemia. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in Rezolute's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission's website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. Rezolute Contacts: Christen Baglaneas 508-272-6717 Carrie McKim 336-608-9706

The Manila Times
Mar 4th, 2026
Rezolute to Participate in the Citizens Life Sciences Conference

Rezolute to participate in the Citizens Life Sciences Conference. By GlobeNewswire March 4, 2026 REDWOOD CITY, Calif., March 04, 2026 (GLOBE NEWSWIRE) - Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced that management will participate in the Citizens Life Sciences Conference, taking place March 10-11, 2026, in Miami, FL. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Citizens representative. About Rezolute, Inc. Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company's antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit www.rezolutebio.com. Rezolute Contacts: Christen Baglaneas 508-272-6717 Carrie McKim powered by 336-608-9706

Rezolute, Inc.
Feb 4th, 2026
Rezolute to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

Rezolute to participate in the Guggenheim Emerging Outlook: Biotech Summit 2026. February 04, 2026 7:00 am EST Download as PDF REDWOOD CITY, Calif., Feb. 04, 2026 (GLOBE NEWSWIRE) - Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced that management will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026, taking place February 11-12, 2026 in New York. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim representative. Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company's antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit www.rezolutebio.com. Released February 4, 2026

Fierce Pharma
Aug 21st, 2025
Rezolute resolves commercial question, hiring ex-Ultragenyx exec to ready for rare disease launch

Karnawat joins Rezolute from Cytokinetics, where he spent just over a year as vice president of global value, access and distribution.

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