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Sio Gene Therapies Inc. (SIOX) SEC Filing 10-Q Quarterly Report for the period ending Friday, December 31, 2021

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SIOX Quarterly Reports

Sio Gene Therapies Inc.

CIK: 1636050 Ticker: SIOX


Exhibit 99.1
sioxa.jpg

Sio Gene Therapies Announces Corporate Updates and Fiscal Third Quarter 2021 Financial Results

Company prioritizing industry-leading clinical-stage programs, AXO-AAV-GM1 and AXO-AAV-GM2, the first potential disease-modifying therapies for GM1 gangliosidosis and Tay-Sachs/Sandhoff disease

$81.9 million of cash and cash equivalents as of December 31, 2021, providing expected cash runway into calendar H2 2023 beyond the expected dates of major upcoming milestones for the AXO-AAV-GM1 and AXO-AAV-GM2 gene therapy programs

NEW YORK, N.Y., AND DURHAM, N.C., February 11, 2022 (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 corporate updates and financial results for its fiscal third quarter ended December 31, 2021.

"As we recently announced, I’m excited to lead Sio as we enhance our focus on rare genetic diseases and implement measures to extend our expected cash runway into the second half of 2023," said David Nassif, J.D., interim Chief Executive Officer of Sio. "While the relentless nature of GM1 and GM2 gangliosidosis drives us to move with urgency every day in order to potentially transform the lives of these patients and their families, we believe our GM1 and GM2 programs also bring meaningful value for our shareholders. These programs represent a critical opportunity, where the life-changing value for families desperately in need and the market value for our shareholders perfectly overlap and provide the motivation to keep our team moving with a sense of purpose for all stakeholders. I look forward to sharing continued updates across each of these programs as they reach meaningful clinical milestones."

Key Developments and Priorities

AXO-AAV-GM1
Presented updated safety data from the most advanced GM1 gene therapy program in the industry, at the 18th Annual WORLDSymposium™ 2022, held from February 7-11, 2022
Ten patients across all pediatric subtypes (early infantile, late infantile, and juvenile) of GM1 gangliosidosis have received AXO-AAV-GM1 gene therapy to date
AXO-AAV-GM1 remains generally well tolerated in all ten patients at both low and high doses to date
There have been no reported drug-related serious adverse events
The majority of adverse events were considered mild to moderate, and no safety signals have been identified
The totality of the data to date have demonstrated a favorable risk: benefit profile and a dose-dependent improvement in key biomarkers of disease activity (β-galactosidase enzyme activity in the serum and GM1 ganglioside activity in the CSF) across the low- and high-dose cohorts
Based on developmental and mobility assessments, there was no clinical evidence of disease progression in 4 out of 5 low-dose subjects at 12 months or in the high-dose cohort at 6 months
Strategic Priorities:
Calendar 1H 2022: Present a data update from Stage 1 of the Phase 1/2 study, including a first look at Type I (early infantile) patients treated in the low-dose cohort and longer-term data from the Type II (late infantile to juvenile) patient cohort at future scientific conferences
Calendar 2022: Intend to engage with the FDA to review Stage 1 data and discuss next steps for clinical development

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The following information was filed by Sio Gene Therapies Inc. (SIOX) on Friday, February 11, 2022 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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Sio Gene Therapies Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

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Inside Sio Gene Therapies Inc.'s 10-Q Quarterly Report:

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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: 0001636050-22-000024
Submitted to the SEC: Fri Feb 11 2022 7:00:45 AM EST
Accepted by the SEC: Fri Feb 11 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations

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