GlobeNewswire Inc | Sep 15, 2021 04:56PM EDT

September 15, 2021

REDWOOD CITY, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced its financial results for the fourth quarter and fiscal full year ended June 30, 2021.

We are very pleased with our overall progress, notably advancement of our clinical programs including RZ358 for congenital hyperinsulinism and RZ402 for diabetic macular edema, said Nevan Elam, Chief Executive Officer and Founder of Rezolute. We have continued to execute on the milestones we laid out prior to the COVID-19 pandemic, including the initiation of patient dosing in the second cohort of the Phase 2b trial of RZ358, and start of the Phase 1b multiple-ascending dose study of RZ402. In addition to these clinical accomplishments, we have further strengthened our leadership team and Scientific Advisory Board with key opinion leaders who will help us advance our programs.

Recent Business Highlights

-- RZ358, monoclonal antibody for the treatment of congenital hyperinsulinism (HI) We are continuing to enroll patients into the second cohort of the Phase 2b RIZE study of RZ358 for the treatment of HI, with topline data expected in Q1 of 2022. RZ358 is designed to increase glucose in the bloodstream of HI patients by reducing insulin activity at its receptor. -- RZ402, oral PKI for the treatment of diabetic macular edema (DME) In May 2021, we announced topline results from our first-in-human Phase 1a clinical study of RZ402, our investigational oral plasma kallikrein inhibitor (PKI), for the treatment of DME. Study results demonstrated the potential for once daily oral dosing. RZ402 is now in a Phase 1b multiple ascending dose study, with topline data expected in Q1 of 2022. -- Key leadership appointments We announced the appointment of Davelyn Hood, MD, an expert in HI, as the Companys Director, Scientific and Patient Affairs; and the appointment of Rajat Agrawal, MD, MS, a key opinion leader in ophthalmology, as Vice President, Clinical Development. -- Scientific Advisory Board (SAB) expansion We announced the addition of two subject matter experts to our SAB: Quan Dong Nguyen, MD, MSc, FAAO, FARVO, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine and Dr. Adrian Vella, MD, Professor of Medicine in the Endocrinology Division at the Mayo Clinic College of Medicine.

Fourth Quarter and Full Year Fiscal 2021 Financial Results

-- Cash and cash equivalents totaled $41.0 million as of June 30, 2021. -- Research and development (R&D) expenses were $4.4 million for the fourth quarter of fiscal 2021, compared to $2.4 million for the same period in fiscal 2020. Full fiscal year 2021 R&D expenses were $15.0 million, compared to $14.5 million in fiscal year 2020. The increases from fiscal year 2020 to fiscal year 2021 were primarily due to increased spending in compensation and benefits, licensing costs and clinical trial costs, partially offset by decreased spending in consulting, outside services and material manufacturing costs. -- General and administrative (G&A) expenses were $2.2 million for the fourth quarter of fiscal 2021, compared to $1.1 million for the same period in fiscal 2020. Full fiscal year 2021 G&A expenses were $7.9 million, compared to $6.1 million in fiscal year 2020. The increases from fiscal year 2020 to fiscal year 2021 were primarily due to compensation and benefits for our administrative and executive workforce along with increased spending in professional services. -- Net loss was $6.5 million, or $0.78 per share for the fourth quarter of fiscal 2021, compared to $3.5 million, or $0.60 per share for the same period in fiscal 2020. Full year fiscal 2021 net loss was $20.9 million, or $2.72 per share, compared to net loss of $20.3 million, or $3.54 per share, for the fiscal year 2020.

About Rezolute, Inc.Rezolute is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Companys lead clinical asset, RZ358, is in Phase 2b development for treatment of congenital hyperinsulinism (HI), a rare pediatric endocrine disorder. The Company is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema. For more information, visit www.rezolutebio.comor follow us on Twitter.

Forward-Looking StatementsThis release, like many written and oral communications presented by Rezolute, Inc. 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 the Company, 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. 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.

Media and Investor ContactArgot Partnersrezolute@argotpartners.com212-600-1902

Rezolute, Inc. Condensed ConsolidatedFinancial Statements Data(in thousands, except per share data) Three Months Ended Twelve Months Ended June 30, June 30, 2021 2020 2021 2020 (unaudited) CondensedConsolidated Statements ofOperations Data: Operating expenses: Research and 4,389 2,445 14,987 14,450 developmentGeneral and 2,247 1,107 7,907 6,071 administrativeTotal operating 6,636 3,552 22,894 20,521 expensesLoss from operations (6,636 ) (3,552 ) (22,894 ) (20,521 ) Non-operating income 146 5 1,992 188 (expense), netNet loss $ (6,490 ) $ (3,547 ) $ (20,902 ) $ (20,333 ) Basic and dilutednet loss per common $ (0.78 ) $ (0.60 ) $ (2.72 ) $ (3.54 ) share Shares used to computebasic and diluted net 8,352 5,866 7,671 5,751 loss per common share June 30, June 30, 2021 2020 CondensedConsolidated Balance Sheets Data:Cash and cash $ 41,047 $ 9,955 equivalentsWorking capital 40,025 7,292 Total assets 42,609 10,965 Long term debt, net 13,968 - of discount ^(1)License fees payable - 1,809 to Xoma ^(2)Accumulated (168,138 ) (147,236 ) deficitTotal stockholders? 26,099 7,365 equity (1) In April 2021, we entered into a $30.0 million Loan Agreement with SLR and certain other Lenders. $15.0 million term A loan was funded on April 14, 2021. (2) In October 2020, we completed a private placement of equity securities for gross proceeds of $41.0 million, resulting in acceleration of the entire $1.4 million outstanding obligation shown above and we paid it on October 23, 2020.