Rezolute Reports Second Quarter Fiscal 2024 Results and Provides Business Update
- RZ358 Phase 3 clinical study underway for congenital hyperinsulinism, with topline results expected in mid-2025.
- RZ358 shows benefit in individual patient cases for tumor-associated hyperinsulinism under Expanded Access Program (EAP).
- Company's financial results for the second quarter of fiscal 2024 indicate $96.0 million in cash, cash equivalents, and investments in marketable debt securities.
- RZ402 Phase 2 study completion for diabetic macular edema, with topline results expected in the second quarter of 2024.
- Appointment of Daron Evans, M.S., M.B.A, as Chief Financial Officer to lead financial operations.
- Innovation and Licensing Application Passport (ILAP) designation awarded to RZ358 for congenital hyperinsulinism treatment by U.K. MHRA.
- Positive outcomes from Expanded Access Program drive alignment with FDA for potential late-stage clinical development of RZ358 in tumor-associated hyperinsulinism.
- Company continues engagement with FDA to resolve partial clinical holds on clinical studies in congenital hyperinsulinism indication.
- Net loss of $13.9 million for the second quarter of fiscal 2024, compared to $13.6 million for the same period in fiscal 2023.
- Decrease in cash, cash equivalents, and investments in marketable debt securities from $118.4 million as of June 30, 2023, to $96.0 million as of December 31, 2023.
- Increase in research and development expenses from $10.9 million for the same period in fiscal 2023 to $12.0 million for the second quarter of fiscal 2024.
The announcement of Rezolute's financial results for the second quarter of fiscal 2024, combined with the update on clinical trial progress, represents a significant event for stakeholders. The company's cash position, with a decrease from $118.4 million to $96.0 million over six months, may raise concerns about the burn rate and the need for future capital. The increased R&D expenses, primarily due to clinical activities and manufacturing costs, indicate an investment in their product pipeline, particularly in RZ358 and RZ402. However, the continued net loss highlights the inherent risks and long runway before potential product commercialization. Investors will be closely monitoring the topline data release for RZ402 in the second quarter of 2024 as a near-term catalyst. The company's ability to manage cash reserves until revenue generation will be critical for investor confidence.
The progression of RZ358 into Phase 3 clinical trials for congenital hyperinsulinism (cHI) and the discussion with the FDA regarding its use in tumor-associated hyperinsulinism (taHI) underlines the therapy's potential impact on these rare diseases. The ILAP designation by the UK's MHRA and the analogous PRIME status by the EMA underscore the treatment's promise and could expedite the review process, potentially leading to a faster market entry in these regions. The unique mechanism of action of RZ358, targeting the insulin receptor on target organs, positions it as a universal treatment candidate for hyperinsulinism-related hypoglycemia. This broad therapeutic potential could expand the addressable market. However, the resolution of partial clinical holds will be crucial for the continuation of clinical studies and future regulatory approval.
The development of treatments for rare diseases like cHI and taHI represents a niche market with high barriers to entry but also significant opportunities due to lack of competition. Rezolute's strategic focus on these areas could capitalize on orphan drug designations, which often come with benefits such as market exclusivity and tax credits. The market's response to the initiation of Phase 3 trials for RZ358 and the potential expansion into taHI will depend on the perceived efficacy and safety profile of the treatment, as well as the company's ability to navigate the regulatory landscape. The market will also be interested in the Phase 2 study results for RZ402 in DME, a condition with a larger patient population and a more competitive market. Positive results could significantly impact Rezolute's market valuation and partnership opportunities.
Phase 3 clinical study of RZ358 underway in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025
Benefit shown in individual patient cases with RZ358 for tumor-associated hyperinsulinism (taHI) under Expanded Access Program (EAP); drives alignment with FDA on unmet need and potential to move into late-stage clinical development to further evaluate RZ358 in this population
REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the second quarter of fiscal 2024 ended December 31, 2023, and provided an update on recent business developments and outlook.
“2024 is an exciting year of execution and milestones across our pipeline, with RZ358 continuing to demonstrate benefit to patients with hypoglycemia resulting from varying causes of hyperinsulinism, and in different indications,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. “We recently initiated sunRIZE, a global, pivotal, Phase 3 clinical study in patients with congenital hyperinsulinism, and we also continue to see favorable outcomes from our Expanded Access Program with RZ358, in patients with tumor-associated hyperinsulinism caused by insulinomas, for which we are evaluating a potential development program. Additionally, we completed enrollment in the Phase 2 study of RZ402 in patients with diabetic macular edema and look forward to reporting topline data from that program in the second quarter of 2024.”
Clinical and Regulatory Highlights
RZ358 is a monoclonal antibody for the treatment of hyperinsulinism.
- cHI
- Rezolute initiated sunRIZE, a global, pivotal, Phase 3 clinical study in participants with cHI, in Europe and other geographies outside of the U.S.
- Topline results expected mid-2025.
- Innovation and Licensing Application Passport (ILAP) designation awarded to RZ358 for the treatment of cHI by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
- Designation was granted based on the recognition of substantial unmet medical need in this condition and the potential benefit to patients as evidenced by the Phase 2b RIZE study results in cHI, which safely demonstrated significant improvements in hypoglycemia.
- Supplements analogous PRIME designation status already granted by the European Medicines Agency (EMA) in E.U.
- Rezolute initiated sunRIZE, a global, pivotal, Phase 3 clinical study in participants with cHI, in Europe and other geographies outside of the U.S.
- taHI
- RZ358 has been shown to counteract excessive insulin action downstream, at the insulin-receptor on target organs. The unique mechanism of action of RZ358 makes the therapy a potential universal treatment for hypoglycemia resulting from any cause of hyperinsulinism, including neuroendocrine tumors (insulinomas).
- Given the unmet need in taHI and the potential therapeutic benefit of RZ358 as demonstrated in the individual case reports from the EAP, the Company met with FDA in January 2024 (January Meeting) and received a favorable opinion from the Agency on the feasibility of RZ358 being studied in a late-stage clinical trial as a new development program and second rare disease indication for RZ358.
- In the January Meeting, FDA indicated that current dose caps on cHI studies would not be applicable to taHI studies. Therefore, considering the indication is primarily adult, current partial clinical holds pertaining to cHI studies would be largely irrelevant in taHI.
- The Company remains engaged with FDA in the attempt to resolve ongoing partial clinical holds on clinical studies in the cHI indication.
RZ402 is a selective and potent oral plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME).
- Completed enrollment in Phase 2 U.S., multi-center, randomized, double-masked, placebo-controlled, parallel-arm study evaluating the safety, efficacy, and pharmacokinetics of RZ402 administered as an oral monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections.
- Topline results expected in the second quarter of 2024.
Corporate Highlights
- Expanded leadership team with appointment of Daron Evans, M.S., M.B.A, as Chief Financial Officer.
- Mr. Evans has substantial experience leading public and private life science companies, with expertise in corporate finance, capital markets, and strategic transactions. He will help shepherd Rezolute through its next chapter in late-stage development.
Second Quarter Fiscal 2024 Financial Results
- Cash, cash equivalents and investments in marketable debt securities totaled
$96.0 million as of December 31, 2023, compared to$118.4 million as of June 30, 2023 - Research and development expenses were
$12.0 million for the second quarter of fiscal 2024, compared to$10.9 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities and manufacturing costs - General and administrative expenses were
$3.2 million for the second quarter of fiscal 2024, compared to$3.4 million for the same period in fiscal 2023, with the decrease primarily attributable to lower personnel-related expenses - Net loss was
$13.9 million for the second quarter of fiscal 2024, compared to$13.6 million for the same period in fiscal 2023
About Rezolute, Inc.
Rezolute strives to disrupt current treatment paradigms by developing transformative therapies for devastating rare and chronic metabolic diseases. Its novel therapies hold the potential to both significantly improve outcomes and reduce the treatment burden for patients, treating physicians, and the healthcare system. Rezolute is steadfast in its mission to create profound, positive, and lasting impacts on patients’ lives. Patient, clinician, and advocate voices are integrated in the Company’s drug development process. Rezolute places an emphasis on understanding the patient’s lived experiences, enabling the Company to boldly address a range of severe conditions. 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 statements regarding the appointment of Daron Evans as Chief Financial Officer, the sunRIZE Phase 3 clinical study, Phase 2 study of RZ402, the Expanded Access Program with RZ358, the ability of RZ358 to become an effective treatment for congenital hyperinsulinism, the effectiveness or future effectiveness of RZ358 for the treatment of congenital hyperinsulinism, and statements regarding clinical trial timelines for RZ358. 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 the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’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.
Investors & Media:
Christen Baglaneas
Rezolute, Inc.
cbaglaneas@rezolutebio.com
(508)272-6717
Investors:
Stephanie Carrington
ICR Westwicke
RezoluteIR@westwicke.com
(646)277-1282
| Rezolute, Inc. | ||||||||||||||||
| Condensed Consolidated Financial Statements Data | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 12,039 | $ | 10,945 | $ | 24,253 | $ | 18,649 | ||||||||
| General and administrative | 3,155 | 3,447 | 6,855 | 5,961 | ||||||||||||
| Total operating expenses | 15,194 | 14,392 | 31,108 | 24,610 | ||||||||||||
| Loss from operations | (15,194 | ) | (14,392 | ) | (31,108 | ) | (24,610 | ) | ||||||||
| Non-operating income, net | 1,285 | 836 | 2,675 | 1,223 | ||||||||||||
| Net loss | $ | (13,909 | ) | $ | (13,556 | ) | $ | (28,433 | ) | $ | (23,387 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.27 | ) | $ | (0.26 | ) | $ | (0.55 | ) | $ | (0.46 | ) | ||||
| Shares used to compute basic and diluted net loss per common share | 51,408 | 51,410 | 51,409 | 50,969 | ||||||||||||
| December 31, | June 30, | |||||||||||||||
| 2023 | 2023 | |||||||||||||||
| Condensed Consolidated Balance Sheets Data: | ||||||||||||||||
| Cash and cash equivalents | $ | 12,504 | $ | 16,036 | ||||||||||||
| Investments in marketable debt securities | 83,446 | 102,330 | ||||||||||||||
| Working capital | 88,077 | 99,710 | ||||||||||||||
| Total assets | 102,150 | 123,721 | ||||||||||||||
| Accumulated deficit | (289,418 | ) | (260,985 | ) | ||||||||||||
| Total stockholders’ equity | 91,728 | 116,172 | ||||||||||||||
FAQ
What is the status of the Phase 3 clinical study of RZ358?
What benefit has been shown with RZ358 in individual patient cases?
What are the financial results for the second quarter of fiscal 2024?
Who was appointed as the Chief Financial Officer of Rezolute?
What designation was awarded to RZ358 for the treatment of congenital hyperinsulinism?
What progress has been made with the Expanded Access Program for RZ358?
