RZLT Rezolute Inc.

6.5
0  0%
Previous Close 6.5
Open 6.5
52 Week Low 5.86
52 Week High 23.5
Market Cap $100,231,625
Shares 15,420,250
Float 9,921,556
Enterprise Value $73,604,625
Volume 72,358
Av. Daily Volume 65,616
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Upcoming Catalysts

Drug Stage Catalyst Date
RZ358 (RIZE)
Congenital hyperinsulinism (HI)
Phase 2b
Phase 2b
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RZ402
Diabetic macular edema
Phase 1b
Phase 1b
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Latest News

  1. REDWOOD CITY, Calif., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced the pricing of an underwritten public offering of 6,030,847 shares of its common stock at a public offering price of $6.50 per share and of pre-funded warrants to purchase 1,661,461 shares of its common stock at a public offering price of $6.49 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each pre-funded warrant.

    In addition, Rezolute today announced the pricing of its concurrent…

    REDWOOD CITY, Calif., Oct. 13, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced the pricing of an underwritten public offering of 6,030,847 shares of its common stock at a public offering price of $6.50 per share and of pre-funded warrants to purchase 1,661,461 shares of its common stock at a public offering price of $6.49 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each pre-funded warrant.

    In addition, Rezolute today announced the pricing of its concurrent registered direct offering to certain institutional investors that are current shareholders, of 769,231 shares of its common stock at a public offering price of $6.50 per share.

    The aggregate gross proceeds to Rezolute from the offerings are expected to be approximately $55 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Rezolute. All shares of common stock and pre-funded warrants to be sold in the underwritten public offering and all shares of common stock to be sold in the registered direct offering will be offered by Rezolute. In addition, Rezolute has granted the underwriters a 30-day option to purchase up to an aggregate of 1,153,845 additional shares of its common stock in the underwritten public offering at the public offering price of $6.50 per share, before underwriting discounts and commissions. The offerings are expected to close on or about October 15, 2021, subject to satisfaction of customary closing conditions, but the closing of the underwritten public offering is not contingent upon the closing of the registered direct offering.

    Rezolute intends to use the net proceeds from both offerings to fund clinical research and development and for working capital and general corporate purposes.

    Oppenheimer & Co. Inc. is acting as the sole bookrunning manager with Roth Capital Partners acting as co-manager for the underwritten public offering. The registered direct offering is being made without an underwriter, placement agent, broker, or dealer.

    The offerings are being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-251498) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on June 23, 2021. A preliminary prospectus supplement and accompanying prospectus related to the underwritten public offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. A final prospectus supplement and accompanying prospectus relating to both offerings will be filed with the SEC. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering may be obtained from: Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Rezolute, Inc.

    Rezolute is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company's 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.com or follow us on Twitter.

    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 statements include, but are not limited to, the offerings. 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, but are not limited to, market risks and uncertainties, the satisfaction of customary closing conditions for an offering of securities, and any other factors discussed in Rezolute's 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.

    Media and Investor Contact

    Argot Partners

    rezolute@argotpartners.com

    212-600-1902



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  2. REDWOOD CITY, Calif., Oct. 12, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering, and, in lieu of common stock, Rezolute intends to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock. Concurrently with the public offering and by means of a prospectus supplement and accompanying prospectus, Rezolute is offering to sell shares of its common stock directly to certain institutional investors that are current shareholders…

    REDWOOD CITY, Calif., Oct. 12, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering, and, in lieu of common stock, Rezolute intends to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock. Concurrently with the public offering and by means of a prospectus supplement and accompanying prospectus, Rezolute is offering to sell shares of its common stock directly to certain institutional investors that are current shareholders, in a registered direct offering.

    In connection with the underwritten public offering, Rezolute intends to grant the underwriters a 30-day option to purchase additional shares of its common stock offered at the public offering price, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants to be sold in the underwritten public offering and the concurrent registered direct offering are to be sold by Rezolute. Both offerings are subject to market and other conditions, and there can be no assurance as to whether or when the offerings may be completed, or as to the actual size or terms of the offerings but the closing of the underwritten public offering is not contingent upon the closing of the registered direct offering.

    Rezolute intends to use the net proceeds from both offerings to fund clinical research and development and for working capital and general corporate purposes.

    Oppenheimer & Co. Inc. is acting as the sole bookrunning manager for the underwritten public offering. The registered direct offering is being made without an underwriter, placement agent, broker, or dealer.

    The offerings are being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-251498) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on June 23, 2021. The offerings may be made only by means of a prospectus supplement and accompanying prospectus which will be available on the SEC's website located at http://www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the underwritten public offering may be obtained from: Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.

    Before investing in the underwritten public offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such underwritten public offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Rezolute, Inc.

    Rezolute is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company's 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.com or follow us on Twitter.

    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 statements include, but are not limited to, the proposed offerings of shares of common stock. 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, but are not limited to, market risks and uncertainties, the satisfaction of customary closing conditions for an offering of securities, and any other factors discussed in Rezolute's 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.

    Media and Investor Contact

    Argot Partners

    rezolute@argotpartners.com

    212-600-1902



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  3. Continuous glucose monitoring reveals undertreated hypoglycemia in patients with congenital hyperinsulinism

    RZ358, a monoclonal antibody in Phase 2b development, has normalized blood glucose levels in prior studies

    REDWOOD CITY, Calif., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today presented results from a natural history study designed to quantify the extent of hypoglycemia in congenital hyperinsulinism (HI) patients on standard of care therapies. The results (E-Poster #P2-234) were presented at the European Society for Paediatric Endocrinology 2021, held virtually September…

    Continuous glucose monitoring reveals undertreated hypoglycemia in patients with congenital hyperinsulinism

    RZ358, a monoclonal antibody in Phase 2b development, has normalized blood glucose levels in prior studies

    REDWOOD CITY, Calif., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today presented results from a natural history study designed to quantify the extent of hypoglycemia in congenital hyperinsulinism (HI) patients on standard of care therapies. The results (E-Poster #P2-234) were presented at the European Society for Paediatric Endocrinology 2021, held virtually September 22-26.

    The two-week observational study was conducted in 22 patients ages two years old and older with HI of various genetic causes, 15 of whom were on at least one standard of care therapy, including diazoxide (50% of the patients) and octreotide (18% of the patients). The remaining patients were managed by other means (tube feeds and/or diet). Glucose control was evaluated by continuous glucose monitors (CGM) for at least two weeks.

    Study Results

    • The mean time in hypoglycemia (±SD, % of monitored time) as measured by CGM (< 70mg/dL) for all participants was 1165 (±164, 11.6%) and 1101 (±152, 10.9%) minutes in weeks 1 and 2, respectively. This included 115 (±36, 0.9%) and 91 (±26, 1.1%) minutes of severe hypoglycemia (<50 mg/dL).
    • A 2 to 6 year-old subgroup (n=9) experienced a mean hypoglycemia duration of 1445 (±161,14.3%) and 1376 (±147, 13.7%) minutes in weeks 1 and 2, respectively with 131 (±36, 1.3%) and 146 (±36, 1.5%) minutes of severe hypoglycemia.
    • The results equate to an average of over 2.5 hours per day spent in hypoglycemia for all participants, and nearly 3.5 hours per day for those between 2 and 6 years old.
    • Notably, patients currently on standard of care therapies experienced a similar magnitude of hypoglycemia.

    Current Pediatric Endocrine Society management guidelines recommend maintenance of blood glucose > 70 mg/dL, and consensus guidelines for diabetes hypoglycemia management recommend targeting less than 4% time in the hypoglycemic range (< 70 mg/dL) by CGM. As measured by CGM in this observational study, patients with congenital HI on available standard of care therapies experienced substantial periods of hypoglycemia, leaving them outside of the recommended blood glucose management guidelines.

    "Cumulative hypoglycemia places patients with congenital HI at risk for adverse clinical outcomes, including developmental delays and permanent neurologic damage," said Davelyn Hood, M.D., Director, Scientific and Patient Affairs at Rezolute. "This natural history study highlighted the extended periods of hypoglycemia regularly experienced by vulnerable pediatric and adult congenital HI patients on currently available therapies, at levels more than three times the magnitude than is recommended for the management of hypoglycemia in diabetes. These results further validate the urgent need to develop innovative new treatments for congenital HI to more effectively treat hypoglycemia and minimize time outside of the recommended blood glucose range, and also highlight the potential role of continuous glucose monitoring to assess glycemic status and responsiveness to therapies."

    Rezolute is currently enrolling patients into the second cohort of the Phase 2b RIZE study of RZ358, the Company's monoclonal antibody for the treatment of HI, with topline data expected in Q1 of 2022.

    About RZ358

    RZ358 is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor throughout the body, such as in the liver, fat, and muscle. The antibody modifies insulin's binding and signaling to maintain glucose levels in a normal range which counteracts the effects of elevated insulin in the body. Rezolute believes that RZ358 is ideally suited as a potential therapy for conditions characterized by excessive insulin levels and is developing it to treat the hyperinsulinism and low blood sugar characteristic of diseases such as congenital hyperinsulinism (HI). As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating HI caused by any of the underlying genetic defects.

    Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical study in patients with congenital hyperinsulinism. RZ358 received Orphan Drug Designation in the United States and European Union as well as Pediatric Rare Disease Designation in the US.

    About Congenital Hyperinsulinism (HI)

    Congenital HI is the most common cause of recurrent hypoglycemia in neonates and infants. It presents in neonates and infants as hypoglycemic episodes, with about 60% of infants with congenital HI experiencing a hypoglycemic episode within the first month of life. These episodes can result in significant brain injury and death if not recognized and managed appropriately. Recurrent hypoglycemic episodes and / or dangerously low blood sugars lead to progressive and irreversible damage over time, including serious and devastating brain and developmental problems. Although most patients with congenital HI can survive into adulthood, the damage from hypoglycemia can affect day-to-day functioning, with lasting symptoms such as seizures, developmental delay, and persistent feeding problems. To date, 14 genes have been found to be the cause of congenital HI. However, one-third or more of patients with congenital HI have an unknown genetic cause. The two most-commonly used long-term medications, diazoxide and octreotide, are not Food and Drug Administration (FDA) approved for all forms of this condition and often are ineffective or have intolerable side effects. In cases of congenital HI that are unresponsive to medical management, surgical removal of a portion or the entire pancreas is required. In those with focal congenital HI where a small portion of the pancreas is affected, surgical removal of the specific affected area often results in a cure. In those with diffuse congenital HI where the whole pancreas is affected, a near-total pancreatectomy is undertaken, but still about half of these children will continue to have hypoglycemia and require medical treatment for congenital HI.

    About Rezolute, Inc.

    Rezolute is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company's 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.com or follow us on Twitter.

    Forward-Looking Statements

    This 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 Contact

    Argot Partners

    rezolute@argotpartners.com

    212-600-1902



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  4. 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…

    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 Company's 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 Company's 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.com or follow us on Twitter.

    Forward-Looking Statements

    This 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 Contact

    Argot Partners

    rezolute@argotpartners.com

    212-600-1902





    Rezolute, Inc.          
    Condensed Consolidated Financial Statements Data          
    (in thousands, except per share data)        
         Three Months Ended Twelve Months Ended 
         June 30,  June 30,  
         2021 2020 2021 2020 
         (unaudited)     
    Condensed Consolidated Statements of Operations Data:           
                 
    Operating expenses:           
    Research and development    4,389   2,445   14,987   14,450  
    General and administrative    2,247   1,107   7,907   6,071  
    Total operating expenses    6,636   3,552   22,894   20,521  
    Loss from operations    (6,636)  (3,552)  (22,894)  (20,521) 
                 
    Non-operating income (expense), net    146   5   1,992   188  
    Net loss    $(6,490) $(3,547) $(20,902) $(20,333) 
                 
    Basic and diluted net loss per common share   $(0.78) $(0.60) $(2.72) $(3.54) 
                 
    Shares used to compute basic and diluted net loss per common share   8,352   5,866   7,671   5,751  
                 
                 
             June 30,  June 30, 
              2021   2020  
                 
    Condensed Consolidated Balance Sheets Data:           
    Cash and cash equivalents       $41,047  $9,955  
    Working capital         40,025   7,292  
    Total assets         42,609   10,965  
    Long term debt, net of discount (1)        13,968   -  
    License fees payable to Xoma (2)        -   1,809  
    Accumulated deficit         (168,138)  (147,236) 
    Total stockholders' equity        26,099   7,365  
                 
    (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. 
     
     





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  5. Tracking to Announce Top line data in Q1 2022

    REDWOOD CITY, Calif., Sept. 09, 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 that it has begun dosing patients in the second cohort of its Phase 2b clinical trial of RZ358 (RIZE). RZ358 is a monoclonal antibody targeting the treatment of hypoglycemia caused by excessive insulin levels and is currently in clinical development for congenital hyperinsulinism (HI), a rare pediatric endocrine disorder.

    Rezolute reported that a dose escalation review committee, comprised of HI expert investigators, voted to approve dose escalation…

    Tracking to Announce Top line data in Q1 2022

    REDWOOD CITY, Calif., Sept. 09, 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 that it has begun dosing patients in the second cohort of its Phase 2b clinical trial of RZ358 (RIZE). RZ358 is a monoclonal antibody targeting the treatment of hypoglycemia caused by excessive insulin levels and is currently in clinical development for congenital hyperinsulinism (HI), a rare pediatric endocrine disorder.

    Rezolute reported that a dose escalation review committee, comprised of HI expert investigators, voted to approve dose escalation and initiation of cohort 2 (6 mg/kg), based on their interim review of safety data from Cohort 1 (3 mg/kg). Following completion of the second cohort, the company plans to initiate a third and likely final cohort at 9 mg/kg.

    "We are making great strides with the RIZE study and based on our recent clinical trial activity, we are tracking toward the original timeline we laid out prior to the COVID-19 pandemic. In that regard, we are expecting to substantially complete enrollment by the end of 2021 and have top-line data in Q1 of 2022," said Brian Roberts, MD, Senior Vice President and Head of Clinical Development at Rezolute. "We will continue to monitor the evolution of the pandemic, including the impact of the Delta variant, which could alter our ability to screen and enroll patients in a timely fashion."

    Rezolute also announced the addition of Adrian Vella, MD, Professor of Medicine in the Endocrinology Division at the Mayo Clinic College of Medicine, to the Company's Scientific Advisory Board. Dr. Vella is a leading expert in hypoglycemic disorders and will provide guidance on the development of RZ358.

    Dr. Roberts noted, "We are pleased to welcome Dr. Vella to our Scientific Advisory Board. Given his background and knowledge of RZ358, he will be extremely valuable to Rezolute as we advance the development of RZ358 for HI and evaluate the possibility of expanding into other related and applicable indications."

    Dr. Vella is a Professor of Medicine in the Mayo Clinic College of Medicine and has published over 160 peer reviewed articles related to endocrinology, metabolic disorders, and diabetes. He is regularly the lead author or editor on evidence-based reviews of hyperinsulinism and hypoglycemia.

    About RIZE (RZ358-606)

    The open-label, repeat-dose Phase 2b study is designed to assess the safety and tolerability of intravenously administered RZ358 in patients with congenital hyperinsulinism inadequately controlled on existing therapies. The Company intends to enroll up to four sequential dosing cohorts, each with up to six to eight patients, starting at a dose of 3 mg/kg and increasing to as high as 9 mg/kg in the final cohort, as needed and tolerated. RZ358 will be administered bi-weekly for a total treatment duration of 8 weeks. The study is being conducted at leading HI centers by Rezolute and its global study partners.

    About RZ358

    RZ358 is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor throughout the body, such as in the liver, fat, and muscle. The antibody modifies insulin's binding and signaling to maintain glucose levels in a normal range which counteracts the effects of elevated insulin in the body. Therefore, the company believes that RZ358 is ideally suited as a potential therapy for conditions characterized by excessive insulin levels, and it is being developed to treat the hyperinsulinism and low blood sugar characteristic of diseases such as congenital HI. As RZ358 acts downstream from the beta cells, it has the potential to be universally effective at treating congenital HI caused by any of the underlying genetic defects.

    RZ358 received Orphan Drug Designation in the United States and European Union as well as Pediatric Rare Disease Designation in the US. Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with congenital hyperinsulinism.

    About Rezolute, Inc.

    Rezolute is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company's 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.com or follow us on Twitter.

    Forward-Looking Statements

    This 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 Contact

    Argot Partners

    rezolute@argotpartners.com

    212-600-1902 



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