SIO GENE THERAPIES INC. : Termination of a Material Definitive Agreement, Results of Operations and Financial Condition, Costs Associated with Exit or Disposal Activities, Settlement FD Disclosure, Financial Statements and Exhibits (Form 8-K)

Section 1.02 Termination of a Material Definitive Agreement.

On April 27, 2022, Sio Gene Therapies Inc. notified on University of Massachusetts School of Medicineor UMMS, to terminate the license agreement, dated
December 7, 2018, to develop and commercialize gene therapy product candidates, including AXO-AAV-GM1 and AXO-AAV-GM2, for the treatment of GM1 gangliosidosis and GM2 gangliosidosis, respectively, or the UMMS License Agreement. Under the terms of the License Agreement, termination will take effect on the 90th calendar day following notice of termination, or earlier if the parties agree. Following such termination, we will no longer have a worldwide, royalty-based, sublicensable license to certain patent applications and all patents derived therefrom, biological materials and know-how controlled by UMMS for develop and commercialize gene therapy product candidates, including AXO-AAV-GM1 and AXO-AAV-GM2. The circumstances surrounding our decision to terminate are described in more detail in point 2.05 of this report, the description of which is incorporated by reference herein.

A summary of the material terms of the UMMS License Agreement has been included in our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2021
filed with the Security and Exchange Commission on February 11, 2022the summary of which is qualified in its entirety by reference to the full text of the UMMS License Agreement, filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2018 filed with the Security and Exchange Commission on February 7, 2019.

Item 2.02 Results of Operations and Financial Condition.

On April 27, 2022we issued a press release announcing, among other things, our estimated cash and cash equivalents of approximately $64 million from March 31, 2022. The estimate is based on currently available information and does not present all of the information necessary for a complete understanding of our financial condition as of March 31, 2022 or our results of operations for the year ended March 31, 2022.

A copy of this press release is provided as Exhibit 99.1 to this report and is incorporated herein by reference. The disclosures set forth in this Section 2.02 and Exhibit 99.1 to this report are provided and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to requirements of this article. The information contained in this Section 2.02 and Exhibit 99.1 of this report shall not be deemed incorporated by reference in any other filing with the Security and Exchange Commission made by us, whether made before or after the date hereof, regardless of the language of general incorporation in such filing.

Item 2.05 Costs associated with removal or disposal activities.

On April 27, 2022, we announced the strategic decision, approved by our Board of Directors, to discontinue clinical development of AXO-AAV-GM1 and AXO-AAV-GM2, to terminate the associated UMMS license agreement and to conduct liquidation activities, and to explore and consider a range of strategic alternatives focused on maximizing shareholder value from our existing cash and cash equivalents, including a possible sale, merger, consolidation of business or similar transaction. As part of these actions, we will implement a significant reduction in the workforce by June 30, 2022. Following a thorough evaluation with our Board of Directors and advisors, we have determined that it is not in the best interests of our shareholders to continue to develop and seek financing for AXO-AAV-GM1 and AXO- AAV-GM2 or other clinical programs given, among other things, the current public funding environment.

As part of these strategic decisions, we expect to incur aggregate costs estimated to be between approximately $0.9 million for $1.5 million related to workforce reductions, all to be incurred during the fiscal quarter
June 30, 2022. The estimate of the costs we expect to incur and their timing are subject to a number of assumptions, and actual results may differ. We may also incur other charges or cash expenses not currently contemplated due to events that may arise as a result of or associated with the decision to terminate the UMMS license agreement and terminate these clinical programs.

Section 7.01 Disclosure of FD Rules.

On April 27, 2022we issued a press release announcing, among other things, the termination of the UMMS license agreement, updates to our operating plan and workforce reductions, and our exploration and review plans of a range of strategic alternatives.

————————————————– ——————————

A copy of this press release is provided as Exhibit 99.1 to this report and is incorporated herein by reference. The disclosures set forth in this Section 7.01 and Exhibit 99.1 to this report are provided and not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the responsibilities of This article. The information contained in this Section 7.01 and Exhibit 99.1 of this report shall not be deemed incorporated by reference in any other filing with the Security and Exchange Commission made by us, whether made before or after the date hereof, regardless of the language of general incorporation in such filing.

Forward-looking statements

This report contains forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “believe”, “would”, “plan”, “explore”, “expect”, “intend”, “estimate”, “may” and other similar expressions are intended to identify forward-looking statements. For example, all statements we make regarding potential strategic alternatives focused on maximizing shareholder value and the related review process, costs associated with our planned operating activities, workforce reductions and capital preservation plans, expectations regarding the ability to obtain financing and expectations regarding licensing and commercial agreements including planned activities, timing and costs associated with the liquidation of clinical programs (including licensing agreements and manufacturing for GM1 and GM2) are looking to the future. All forward-looking statements are based on our management’s estimates and assumptions which, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those we expected. These risks and uncertainties include, among others, the impact of the COVID-19 pandemic on our operations; actual funds required for planned operating activities, including liquidation activities for clinical programs and exploration of strategic alternatives; costs and risks related to workforce reductions and capital conservation plans; the ability to explore and execute strategic alternatives; the ability to effectively scale down clinical programs and conduct required activities during phase-down processes; the outcome of interactions with regulators.

These statements are also subject to a number of important risks and uncertainties which are described in our most recent Quarterly Report on Form 10-Q filed with the Security and Exchange Commission on February 11, 2022as updated by its subsequent filings with the Security and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Item 9.01 Financial statements and supporting documents.

(d) Exhibits.

    Exhibit
    Number                                       Description of Document

     99.1               Press Release of Sio Gene Therapies Inc., dated April 27, 2022, "Sio Gene
                      Therapies Provides Corporate Update"

      104             Cover Page Interactive Data File (embedded within the Inline XBRL document)

————————————————– ——————————

© Edgar Online, source Previews