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Last10K.com | 10-Q Quarterly Report Thu Aug 12 2021
Exhibit 99.1
Sio Gene Therapies Announces Corporate Updates and Fiscal First Quarter 2021 Financial Results
–Completed targeted enrollment of Type II patients in ongoing dose-escalation study of AXO-AAV-GM1 in GM1 gangliosidosis
–On track to report 12-month topline safety, biomarker, and clinical outcomes data from low-dose cohort of AXO-AAV-GM1 in late Q3 or early Q4 2021
–Strong cash position with $111 million of cash and cash equivalents as of June 30, 2021, providing cash runway into Q4 2022
NEW YORK, NY AND RESEARCH TRIANGLE PARK, NC, August 12, 2021 (GLOBE NEWSWIRE) – Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives of patients with neurodegenerative diseases, today provided a corporate update and financial results for its fiscal first quarter ended June 30, 2021.
“We are enormously grateful for the support of the patient community and our clinical investigators as we mark a milestone in the GM1 gangliosidosis gene therapy program with the enrollment of the targeted eight Type II children in the dose-escalation stage of our clinical trial of AXO-AAV-GM1,” said Pavan Cheruvu, M.D., Chief Executive Officer of Sio Gene Therapies. “We are focused on continued clinical execution and look forward to presenting 12-month data from the low-dose cohort of this study in the second half of this year. With this additional data in hand, as well as emerging data from the high-dose cohort, we expect to meet with the FDA in the first half of 2022 to discuss the registrational pathway in GM1 gangliosidosis.”
Dr. Cheruvu continued, “The deep expertise and commitment of the Sio team, paired with our strong balance sheet, leaves us well positioned for continued execution to advance our pipeline of transformative gene therapies that address rare pediatric and adult neurodegenerative disease.”
Key Highlights and Development Updates
AXO-AAV-GM1 gene therapy for GM1 gangliosidosis
•Completed enrollment and dosing of eight late infantile and juvenile-onset (Type II) patients across the low-dose (n=5) and high-dose (n=3) cohorts, achieving the targeted enrollment of Type II patients in Stage 1 (dose-escalation) of the trial. The Company continues to collect information from additional Type II patients for potential enrollment in Stage 2 of the trial.
•Enrollment and screening of Type I (infantile-onset) patients for the low- and high-dose cohorts has been initiated.
•Cerebrospinal fluid (CSF) biomarker data presented at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting demonstrated reductions in CSF GM1 ganglioside in 4 out of 5 children treated with the lowest dose of AXO-AAV-GM1 at 6-months follow up, providing the first evidence of a biochemical effect in the CNS following intravenous delivery.
•Upcoming milestones:
▪12-month topline safety, biomarker, and efficacy data from the low-dose cohort in late Q3 or early Q4 2021.
▪Meeting with the U.S. Food and Drug Administration (FDA) to discuss the registrational pathway for AXO-AAV-GM1 in the first half of 2022.
AXO-AAV-GM2 gene therapy for Tay-Sachs and Sandhoff diseases
•Dosed first two patients in the Phase 1/2 trial investigating AXO-AAV-GM2 in Tay-Sachs and Sandhoff diseases, including one patient at the starting dose and one patient at the low dose.
•Expect continued patient identification, screening, and enrollment in Stage 1 of the dose-ranging trial throughout 2021.
AXO-Lenti-PD gene therapy for Parkinson’s disease
•Two GMP batches have been manufactured using an updated suspension-based process and have now completed fill and finish. Sio is awaiting final testing of these batches to support certification of at least one batch for use as clinical trial material by a Qualified Person in Q4 2021.
1
The following information was filed by Sio Gene Therapies Inc. (SIOX) on Thursday, August 12, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Other - Other Highlight
Tay-Sachs and Sandhoff diseases result in approximately 50% mortality by three and a half years of age and 75% mortality by five years of age.
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Financial - Expense Highlight
The decrease in interest expense during the current year period was due to the April 2020 prepayment of the $15.7 million outstanding principal balance on our loan and security agreement with Hercules Capital, Inc. ("Hercules").
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Financial - Shares Highlight
However, certain RSL equity instruments, which will vest only to the extent certain RSL liquidity conditions and vesting requirements are achieved by a specified date in the future, are held by our Chief Executive Officer, which could result in significant stock-based compensation expense allocated to us from RSL in the future, if achieved.
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Other - Other Highlight
Our Product Pipeline The following table summarizes the status of our gene therapy development programs, for which we hold global commercial rights to each: Gene Therapy Program Clinical Indication Clinical Development Stage AXO-AAV-GM1 GM1 gangliosidosis Phase 1/2 AXO-AAV-GM2 GM2 gangliosidosis (including Phase 1/2 Tay-Sachs and Sandhoff diseases) AXO-Lenti-PD Parkinson's disease Phase 2 19 AXO-AAV-GM1 and AXO-AAV-GM2 Programs Overview We are developing AXO-AAV-GM1 and AXO-AAV-GM2 as potential one-time disease-modifying treatments for GM1 and GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), respectively.
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Financial - Expense Highlight
The $2.9 million increase was primarily related to increases in: (i) AXO-AAV-GM1 clinical trial material manufacturing expenses for the planned enrollment of infantile patients in the high dose cohort, as well as clinical trial expenses due to the ongoing enrollment of juvenile patients in the high dose cohort and for the planned enrollment of infantile patients in the low dose cohort; (ii) AXO-AAV-GM2 clinical trial expenses associated with the ongoing enrollment of juvenile patients in the low dose cohort and for the planned enrollment of patients in the low-to-mid dose cohorts, as well as clinical trial material manufacturing expenses for the planned enrollment of patients in the mid-to-high dose cohorts (versus the prior year period, when this program was on clinical hold); and (iii) personnel-related costs primarily due to increased headcount.
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32 For the three months...Read more
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In this study, ProSavin was...Read more
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Dopamine deficiency plays a central...Read more
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Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
Cover
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statement Of Cash Flows
Condensed Consolidated Statements Of Comprehensive Loss
Condensed Consolidated Statements Of Operations
Condensed Consolidated Statements Of Operations (Parenthetical)
Condensed Consolidated Statements Of Stockholders??? Equity
Condensed Consolidated Statements Of Stockholders??? Equity (Parenthetical)
Accrued Expenses
Accrued Expenses (Details)
Accrued Expenses (Tables)
Commitments And Contingencies
Commitments And Contingencies (Details)
Description Of Business
Description Of Business (Details)
Investment In Arvelle Therapeutics B.V.
Investment In Arvelle Therapeutics B.V. (Details)
License And Collaboration Agreements
License And Collaboration Agreements (Details)
Long Term Debt
Long Term Debt (Details)
Stock-Based Compensation
Stock-Based Compensation (Details)
Stockholders' Equity
Stockholders' Equity (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Money Market Fund (Details)
Summary Of Significant Accounting Policies - Narrative (Details)
Material Contracts, Statements, Certifications & more
Sio Gene Therapies Inc. provided additional information to their SEC Filing as exhibits
Ticker: SIOX
CIK: 1636050
Form Type: 10-Q Quarterly Report
Accession Number: 0001636050-21-000072
Submitted to the SEC: Thu Aug 12 2021 7:21:30 AM EST
Accepted by the SEC: Thu Aug 12 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations
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