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 For the quarterly period ended September 30, 2021

Delaware						85-3863315
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)
130 West 42nd St., 26th Floor, New York, NY						10036
(Address of principal executive offices)						(Zip Code)

Registrant’s telephone number, including area code: (877) 746-4891

Title of each Class

Trading Symbol

Name of each exchange on which registered

Common Stock, par value $0.00001 per share

SIOX

The Nasdaq Stock Market LLC

Large accelerated filer			☐			Accelerated filer			☐

Non-accelerated filer			☒			Smaller reporting company			☒

						Emerging growth company			☐

			Page
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited):
Condensed Consolidated Balance Sheets as of September 30, 2021 and March 31, 2021			5
Condensed Consolidated Statements of Operations for the Three and Six-Months Ended September 30, 2021 and 2020			6
Condensed Consolidated Statements of Comprehensive Loss for the Three and Six-Months Ended September 30, 2021 and 2020			7
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six-Months Ended September 30, 2021 and 2020			8
Condensed Consolidated Statements of Cash Flows for the Six Months Ended September 30, 2021 and 2020			9
Notes to Condensed Consolidated Financial Statements			10
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			18
Item 3. Quantitative and Qualitative Disclosures About Market Risk			29
Item 4. Controls and Procedures			29
PART II. OTHER INFORMATION
Item 1. Legal Proceedings			31
Item 1A. Risk Factors			32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			81
Item 3. Defaults Upon Senior Securities			81
Item 4. Mine Safety Disclosures			81
Item 5. Other Information			81
Item 6. Exhibits			82
SIGNATURES			83

•We have a limited operating history and have never generated any product revenues.

•We are heavily dependent on the success of our gene therapy product candidates, which are still in early stages of clinical development. If we are unable to successfully develop and commercialize any of our product candidates, our business will be harmed.

•We may be required to continue to make significant payments to third parties under the agreements pursuant to which we acquired our gene therapy product candidates.

•Gene therapies are novel, complex, difficult and expensive to manufacture. We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of our product candidates. Delays in manufacturing processes, including recently at Oxford, may result in delays in our planned clinical trials that would otherwise harm our business and prospects.

•Our business plan may lead to the initiation of one or more gene therapy development programs, the discontinuation of one or more development programs, or the execution of one or more transactions that you do not agree with or that you do not perceive as favorable to your investment.

•Clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome.

•If we are not able to obtain required regulatory approvals, we will not be able to commercialize our gene therapy product candidates, and our ability to generate revenue will be materially impaired.

•The intended tax effects of our corporate structure prior to and following the Domestication (as defined below) and our corporate reorganization to align our corporate structure with current and future business activity (the "Reorganization"), and intercompany arrangements prior to the Domestication and Reorganization, depend on the application of the tax laws of various jurisdictions and on how we operate our business.

•We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

•We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.

•Interim "top-line" and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

•Our gene therapy product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.

•Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.

•If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing our product candidates, even if approved.

•If the market opportunities for any product candidates we may develop are smaller than we believe they are, our revenues, if any, may be adversely affected, and our business may suffer. Because the target patient populations for many of the product candidates we may develop are small, we must be able to successfully identify patients and achieve a significant market share to achieve and maintain profitability and growth.

•We face significant competition from other biotechnology and pharmaceutical companies, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours and our operating results will suffer if we fail to compete effectively.

•We may not be able to protect our intellectual property rights throughout the world, which could impair our business.

•Third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights may delay or prevent the development and commercialization of our product candidates.

•The market price of our common stock has been and is likely to continue to be highly volatile, and you may lose some or all of your investment.

PART I.         FINANCIAL INFORMATION

Item 1.         Financial Statements (Unaudited)

			September 30, 2021						March 31, 2021
Assets
Current assets:
Cash and cash equivalents			$	101,695					$	118,986
Restricted cash			1,184						—
Receivable from sale of long-term investment			—						4,343
Prepaid expenses and other current assets			4,321						7,348
Income tax receivable			1,733						1,656
Total current assets			108,933						132,333
Long-term restricted cash			—						1,184
Operating lease right-of-use assets			1,052						1,152
Property and equipment, net			548						478
Total assets			$	110,533					$	135,147
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable			$	2,673					$	1,341
Accrued expenses			7,366						9,196
Current portion of operating lease liabilities			269						311
Total current liabilities			10,308						10,848
Operating lease liabilities, net of current portion			865						932
Total liabilities			11,173						11,780
Commitments and contingencies (Note 9)
Stockholders’ equity:
Common stock, par value $0.00001 per share, 1,000,000,000 shares authorized, 72,941,507 and 69,377,567 issued and outstanding at September 30, 2021 and March 31, 2021, respectively			1						1
Additional paid-in capital			923,198						914,100
Accumulated deficit			(824,176)						(791,069)
Accumulated other comprehensive income			337						335
Total stockholders’ equity			99,360						123,367
Total liabilities and stockholders’ equity			$	110,533					$	135,147

			Three Months Ended September 30,												Six Months Ended September 30,
			2021						2020						2021						2020
Operating expenses:
Research and development expenses
(includes stock-based compensation expense of $489 and $458 for the three months ended September 30, 2021 and 2020 and $921 and $1,021 for the six months ended September 30, 2021 and 2020, respectively)			$	11,448					$	5,058					$	19,506					$	10,252
General and administrative expenses
(includes stock-based compensation expense of $6,809 and $650 for the three months ended September 30, 2021 and 2020 and $7,698 and $1,677 for the six months ended September 30, 2021 and 2020, respectively)			9,748						4,491						13,607						9,131
Total operating expenses			21,196						9,549						33,113						19,383
Other (income) expenses:
Interest expense			11						1						12						797
Other expense (income)			30						580						10						(1,486)
Loss before income tax benefit			(21,237)						(10,130)						(33,135)						(18,694)
Income tax benefit			—						(146)						(28)						(116)
Net loss			$	(21,237)					$	(9,984)					$	(33,107)					$	(18,578)
Net loss per share of common stock — basic and diluted			$	(0.29)					$	(0.21)					$	(0.45)					$	(0.41)
Weighted-average shares of common stock outstanding — basic and diluted			72,941,507						46,731,666						72,901,906						45,018,855

			Three Months Ended September 30,												Six Months Ended September 30,
			2021						2020						2021						2020
Net loss			$	(21,237)					(9,984)						$	(33,107)					(18,578)
Other comprehensive income:
Foreign currency translation adjustment			—						348						2						392
Total other comprehensive income			—						348						2						392
Comprehensive loss			$	(21,237)					$	(9,636)					$	(33,105)					$	(18,186)

			Common Stock												Additional Paid-in Capital						Accumulated Deficit						Accumulated Other Comprehensive Income (Loss)						Total Stockholders’ Equity
			Shares						Amount
Balance at March 31, 2020			39,526,299						$	—					$	820,257					$	(758,644)					$	(55)					$	61,558
Shares issued upon settlement of restricted stock units			53,653						—						—						—						—						—
Shares sold in connection with at-the-market offering, net of brokerage fees and offering expenses of $0.5 million			1,393,428						—						3,930						—						—						3,930
Stock-based compensation expense			—						—						1,590						—						—						1,590
Capital contribution received from affiliate			—						—						53						—						—						53
Foreign currency translation adjustment			—						—						—						—						44						44
Net loss			—						—						—						(8,594)						—						(8,594)
Balance at June 30, 2020			40,973,380						$	—					$	825,830					$	(767,238)					$	(11)					$	58,581
Shares issued for restricted stock units			60,676						—						—						—						—						—
Shares sold in connection with at-the-market offering, net of brokerage fees and offering expenses of $0.7 million			6,215,673						—						19,598						—						—						19,598
Stock-based compensation expense			—						—						1,108						—						—						1,108
Capital contribution received from affiliate			—						—						22						—						—						22
Foreign currency translation adjustment			—						—						—						—						348						348
Net loss			—						—						—						(9,984)						—						(9,984)
Balance at September 30, 2020			47,249,729						$	—					$	846,558					$	(777,222)					$	337					$	69,673

			Common Stock												Additional Paid-in Capital						Accumulated Deficit						Accumulated Other Comprehensive Income (Loss)						Total Stockholders’ Equity
			Shares						Amount
Balance at March 31, 2021			69,377,567						$	1					$	914,100					$	(791,069)					$	335					$	123,367
Shares issued upon settlement of restricted stock units			82,542						—						—						—						—						—
Shares sold in connection with at-the-market offering, net of brokerage fees and offering expenses of $0.0 million			179,400						—						479						—						—						479
Stock-based compensation expense			—						—						1,321						—						—						1,321
Foreign currency translation adjustment			—						—						—						—						2						2
Net loss			—						—						—						(11,870)						—						(11,870)
Balance at June 30, 2021			69,639,509						$	1					$	915,900					$	(802,939)					$	337					$	113,299
Shares issued upon exercise of pre-funded warrants			3,301,998						—						—						—						—						—
Stock-based compensation expense			—						—						7,298						—						—						7,298
Net loss			—						—						—						(21,237)						—						(21,237)
Balance at September 30, 2021			72,941,507						$	1					$	923,198					$	(824,176)					$	337					$	99,360

			Six Months Ended September 30,
			2021						2020
Cash flows from operating activities:
Net loss			$	(33,107)					$	(18,578)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of operating lease right-of-use assets			100						869
Stock-based compensation expense			8,619						2,698
Depreciation and non-cash amortization			122						672
Gain on long-term investment			—						(2,184)
Change in operating lease liabilities			(109)						(879)
Other			4						399
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			3,027						(2,435)
Income tax receivable			(77)						(40)
Other non-current assets			—						(123)
Accounts payable			1,332						(2,240)
Accrued expenses			(1,830)						(3,482)
Net cash used in operating activities			(21,919)						(25,323)
Cash flows from investing activities:
Cash proceeds from sale of long-term investment			4,343						—
Purchases of property and equipment			(194)						(130)
Net cash provided by (used in) investing activities			4,149						(130)
Cash flows from financing activities:
Payments on long-term debt			—						(15,731)
Capital contributions received from affiliate			—						75
Cash proceeds from issuance of shares of common stock, net of issuance costs			479						23,528
Net cash provided by financing activities			479						7,872
Net change in cash and cash equivalents, restricted cash and long-term restricted cash			(17,291)						(17,581)
Total cash and cash equivalents, restricted cash and long-term restricted cash—beginning of period			120,170						80,752
Total cash and cash equivalents, restricted cash and long-term restricted cash—end of period			$	102,879					$	63,171
Cash and cash equivalents—beginning of period			118,986						80,752
Restricted cash included in long-term assets—beginning of period			1,184						—
Total cash and cash equivalents, restricted cash and long-term restricted cash—beginning of period			$	120,170					$	80,752
Cash and cash equivalents—end of period			101,695						63,171
Restricted cash included in current assets—end of period			1,184						—
Total cash and cash equivalents, restricted cash and long-term restricted cash—end of period			$	102,879					$	63,171

Basic net loss per share of common stock is computed by dividing the net loss applicable to holders of common stock by the weighted-average number of shares of common stock and 3,301,998 pre-funded warrants (see Note 7(B)) outstanding during the period, without further consideration for potentially dilutive securities. The pre-funded warrants were fully exercised in July 2021 (see Note 7(B)). In accordance with ASC Topic 260, Earnings Per Share, the pre-funded warrants were included in the computation of basic net loss per share because the exercise price was negligible and they were fully vested and exercisable at any time after the original issuance date. Diluted net loss per share of common stock is computed by dividing the net loss applicable to holders of common stock by the diluted weighted-average number of shares of common stock outstanding during the period calculated in accordance with the treasury stock method. In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per share of common stock and diluted net loss per share of common stock are equivalent. Potentially dilutive shares of common stock have been excluded from the diluted net loss per share of common stock computations in all periods presented because such securities have an anti-dilutive effect on net loss per share of common stock due to the Company’s net loss. Restricted Stock Units ("RSUs") and stock options outstanding for totals of 5.5 million and 3.1 million shares of common stock were not included in the calculation of diluted weighted-average shares of common stock outstanding for the three and six- months ended September 30, 2021 and September 30, 2020, respectively, because they were anti-dilutive given the net loss of the Company.

•Level 1-Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.

•Level 2-Valuations are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.

•Level 3-Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.

						As of September 30, 2021																								As of March 31, 2021
						Fair Value						Price Quotations (Level 1)						Significant Other Observable Inputs (Level 2)						Significant Unobservable Inputs (Level 3)						Fair Value						Price Quotations (Level 1)						Significant Other Observable Inputs (Level 2)						Significant Unobservable Inputs (Level 3)
Money market fund						$	100,000					$	100,000					$	—					$	—					$	114,000					$	114,000					$	—					$	—

In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments" ("ASU No. 2016-13"). ASU 2016-13 requires that financial assets measured at amortized cost, such as loans, accounts and trade receivables and investments, be represented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions, and future expectation for each pool of similar financial asset. ASU No. 2016-13 requires enhanced disclosures related to trade receivables and associated credit losses. In May 2019, the FASB issued ASU No. 2019-05, “Financial Instruments — Credit Losses (Topic 326): Targeted Transition Relief", which allows for a transition election on certain instruments and is effective for Small Reporting Companies for fiscal years beginning after December 15, 2022 and interim periods in those fiscal years. In November 2019, the FASB issued ASU No. 2019-11, "Codification Improvements to Topic 326, Financial Instruments — Credit Losses", which amends certain aspects of ASU NO. 2016-13, including transition relief for trouble debt restructuring, among other topics. While the Company does not expect the adoption of this guidance to materially impact the Company's consolidated financial statements and accompanying notes because it does not currently have any investments or trade receivables outstanding, the impact on the Company's consolidated financial statements and accompanying notes will depend on the facts and circumstances of any specific future transactions.

(A) The University of Massachusetts Medical School Exclusive License Agreement:

(B) Oxford Biomedica License Agreement:

						September 30, 2021						March 31, 2021
Research and development expenses						$	4,625					$	6,091
Bonuses and other compensation expenses						1,893						2,331
Other expenses						848						774
Total accrued expenses						$	7,366					$	9,196

•the success and timing of our ongoing development and potential commercialization of our product candidates;

•our relationships under our license agreements;

•the success of our interactions with the U.S. Food and Drug Administration ("FDA") and international regulatory authorities;

•the anticipated start dates, durations and completion dates of our ongoing and future nonclinical studies and clinical trials, as well as subsequent portions or cohorts of our ongoing clinical trials;

•the receipt of approvals or endorsements by data monitoring or other committees necessary for commencement or continuation of clinical trials; 

•the anticipated designs of our future clinical studies;

•anticipated future regulatory submissions and the timing of and our ability to obtain and maintain regulatory approval for our product candidates;

•the rate and degree of market acceptance and clinical utility of any approved product candidate;

•our ability to identify and in-license or acquire additional product candidates;

•our commercialization, marketing and manufacturing capabilities and strategy;

•continued service of our executive officers or other key scientific or management personnel;

•our ability to obtain, maintain and enforce intellectual property rights for our product candidates;

•our anticipated future cash position;

•our estimates regarding our results of operations, financial condition, liquidity, capital requirements, prospects, growth and strategies;

•our ability to maintain and operate our business in light of the COVID-19 pandemic;

•the success of competing therapies that are or may become available; and

•our stated objective of building the world's leading gene therapy company for the treatment of neurological diseases.

We believe the favorable tolerability in the low-dose cohort supports continued enrollment of patients in the high-dose cohort (4.5×1013 vg/kg), in which three Type II patients have now been dosed without complications.

The current Phase 1/2 study (NCT04669535) is an open-label, two-stage clinical trial designed to evaluate safety and dose escalation (Stage 1) and safety and efficacy (Stage 2) of surgical delivery of AXO-AAV-GM2 directly to the brain and spinal cord of pediatric participants with both infantile and juvenile GM2 gangliosidosis (also known as Tay-Sachs or Sandhoff diseases). In November 2021, we announced that the FDA granted Fast Track Designation to AXO-AAV-GM2. We have dosed the first three patients in the clinical trial under this IND in January 2021, May 2021 and September 2021, and we expect continued patient identification, screening, and enrollment in Stage 1 of the dose-ranging trial throughout 2021. The vector dose administration is divided into an intra-thecal and bilateral intra-thalamic administrations. The first patient received a total dose of 1.42×1014 vg and the subsequent two patients received a total dose of 1.95×1014 vg.

The target dose being tested in Cohort 2 is 9.0×106 transducing units, which is three times higher than the dose used in Cohort 1. AXO-Lenti-PD was observed to be generally well-tolerated in this cohort also, with no SAEs attributable to the gene therapy. In October 2020, we reported that all four patients in the cohort were able to complete the six-month evaluations that do not require an inpatient visit (Hauser diary, Levodopa Equivalent Daily Dose), and only two of the four were able to complete the UPDRS Part II and III evaluations – one patient refused this evaluation and the other was not able to be seen in the clinic since it was closed due to COVID-19 response measures. For the same reasons, only two of the four patients were able to complete the UPDRS Part II and III evaluations at month 12. At both the six- and 12-month evaluations, UPDRS Part II (activities of daily living) and UPDRS Part III (motor) scores, in the state "OFF" levodopa therapy, were stable or improved compared to baseline in all patients with available data. At month 12, the patients experienced an average improvement from baseline in UPDRS Part III (motor) OFF score of 14 points, representing an average improvement of 29% from baseline. Individual patient improvements from baseline at 12 months of 23 and 5 points were observed. Similarly, at 12 months, the patients experienced an improvement in the UPDRS Part II (quality of life) OFF score of 4 points, which represents a 27% improvement. Individual patients’ improvement from baseline were 8 and 0 points. The Hauser diary was completed by all four patients and demonstrated an improvement from baseline of 2.1 hours in OFF time and 1.8 hours in good ON time.

•direct third-party costs, which include expenses incurred under agreements with CROs and contract manufacturing organizations, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, and any other third-party expenses directly attributable to the development of our product candidates; and

•upfront payments for the purchase of in-process research and development and milestone payments, which include costs incurred under our agreements with the University of Massachusetts Medical School ("UMMS") and Oxford Biomedica (UK) Ltd. ("Oxford").

•stock-based compensation expense for research and development personnel;

•personnel-related expenses, which include employee-related expenses, such as salaries, benefits and travel expenses, for research and development personnel; and

•other expenses, which include laboratory facility rental costs and research and development equipment depreciation expenses, as well as the cost of consultants who assist with our research and development but are not allocated to a specific program.

•the number of trials required for approval;

•the per patient trial costs;

•the number of patients who participate in the trials;

•the number of sites included in the trials;

•the countries in which the trials are conducted;

•the length of time required to enroll eligible patients;

•the dose that patients receive;

•the drop-out or discontinuation rates of patients;

•the potential additional safety monitoring or other studies requested by regulatory agencies;

•the duration of patient follow-up;

•any delays in key trial activities and patient enrollment or diversion of healthcare resources as a result of the COVID-19 pandemic;

•production shortages or other supply interruptions in clinical trial materials resulting from the COVID-19 pandemic;

•the timing and receipt of regulatory approvals; and

•the efficacy and safety profile of the product candidates.

•excluding stock-based compensation expense, our general and administrative expenses will at least approximate those incurred during the six months ended September 30, 2021; and

•our quarterly general and administrative stock-based compensation expense will decline significantly on a quarterly basis relative to that incurred during the three months ended September 30, 2021, which included $5.9 million of stock-based compensation expense associated with certain RSL equity instruments held by our Chief Executive Officer for which expensing commenced upon the liquidity event vesting condition being met upon the closing of RSL's business combination with Montes Archimedes Acquisition Corp. ("MAAC") on September 30, 2021.

			Three Months Ended September 30,																		Six Months Ended September 30,
			2021						2020						Change						2021						2020						Change
Operating expenses:
Research and development expenses
(includes stock-based compensation expense of $489 and $458 for the three months ended September 30, 2021 and 2020 and $921 and $1,021 for the six months ended September 30, 2021 and 2020, respectively)			$	11,448					$	5,058					$	6,390					$	19,506					$	10,252					$	9,254
General and administrative expenses
(includes stock-based compensation expense of $6,809 and $650 for the three months ended September 30, 2021 and 2020 and $7,698 and $1,677 for the six months ended September 30, 2021 and 2020, respectively)			9,748						4,491						5,257						13,607						9,131						4,476
Total operating expenses			21,196						9,549						11,647						33,113						19,383						13,730
Interest expense			11						1						10						12						797						(785)
Other expense (income)			30						580						(550)						10						(1,486)						1,496
Loss before income tax benefit			(21,237)						(10,130)						(11,107)						(33,135)						(18,694)						(14,441)
Income tax benefit			—						(146)						146						(28)						(116)						88
Net loss			$	(21,237)					$	(9,984)					$	(11,253)					$	(33,107)					$	(18,578)					$	(14,529)

			Three Months Ended September 30,																		Six Months Ended September 30,
			2021						2020						Change						2021						2020						Change
Program-specific costs:
AXO-AAV-GM1 and AXO-AAV-GM2			$	6,906					$	415					$	6,491					$	10,324					$	800					$	9,524
AXO-Lenti-PD			475						1,729						(1,254)						1,033						3,387						(2,354)
Unallocated internal costs:
Personnel-related			2,163						1,680						483						4,663						3,640						1,023
Stock-based compensation expense			489						458						31						921						1,021						(100)
Other			1,415						776						639						2,565						1,404						1,161
Total research and development expenses			$	11,448					$	5,058					$	6,390					$	19,506					$	10,252					$	9,254

•the progress, timing, costs and results of our clinical trials of our product candidates;

•the outcome, timing and cost of meeting regulatory requirements established by the FDA, the European Medicines Agency, or Japan’s Pharmaceutical and Medical Devices Agency, and other comparable foreign regulatory authorities;

•the achievement of certain development, regulatory and commercialization milestones that give rise to milestone and royalty payments to licensors;

•the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

•the cost of obtaining necessary intellectual property and defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates or any future product candidates;

•the effect of competing technological and market developments;

•the cost and timing of completion of clinical-stage and commercial-scale manufacturing activities, including costs that may result from delays in the development of a suspension-based manufacturing process by our partner, Oxford;

•the cost of establishing sales, marketing and distribution capabilities for our product candidates in regions where we choose to commercialize our products on our own; and

•the initiation, progress, timing and results of our commercialization of our product candidates, if approved for commercial sale.

			Six Months Ended September 30,
			2021						2020
Net cash used in operating activities			$	(21,919)					$	(25,323)
Net cash provided by (used in) investing activities			4,149						(130)
Net cash provided by financing activities			479						7,872

Item 1.         Legal Proceedings

Item 1A.         Risk Factors

•successfully commence and complete clinical trials and obtain regulatory approval for the marketing of our gene therapy product candidates;

•establish effective sales, marketing and distribution systems for our gene therapy product candidates;

•add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future commercialization efforts and operations as a public company;

•initiate and continue relationships with third-party suppliers and manufacturers, including Oxford Biomedica (UK) Ltd. ("Oxford"), Viralgen Vector Core, S.L. and other third-party cGMP manufacturers, and have clinical and commercial quantities of our gene therapy product candidates manufactured at acceptable cost and quality levels;

•attract and retain an experienced management and advisory team;

•raise additional funds when needed and on terms acceptable to us;

•achieve broad market acceptance of our products in the medical community and with third-party payors and consumers;

•launch commercial sales of our products, whether alone or in collaboration with others;

•compete effectively with other biotechnology and gene therapy companies targeting neurological diseases; and

•obtain, maintain, expand and protect necessary intellectual property rights.

•we may not be able to demonstrate that a product candidate is safe and effective as a treatment for our targeted indications to the satisfaction of the applicable regulatory authorities;

•our BLA or other key regulatory filings may be delayed or rejected due to issues, including those related to product quality and manufacturing, timing of results from supporting studies, database lock and data transfer;

•the regulatory authorities may require additional nonclinical studies or clinical studies of the product candidate in Parkinson’s disease or other indications, which would increase our costs and prolong our development;

•the results of our clinical trials may not meet the level of statistical or clinical significance required for marketing approval;

•the regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials;

•the contract research organizations ("CROs") that we retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or breaches of protocols, that adversely impact our clinical trials;

•the regulatory authorities may not find the data from nonclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of the product candidate outweigh its safety risks;

•the regulatory authorities may disagree with our interpretation of data from our nonclinical studies and clinical trials or may require that we conduct additional studies;

•the regulatory authorities may not accept data generated at our clinical trial sites;

•the regulatory authorities may require, as a condition of approval, limitations on approved labeling or distribution and use restrictions;

•the FDA may require development of a risk evaluation and mitigation strategy ("REMS") as a condition of approval;

•the regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers; or

•the regulatory authorities may change their approval policies or adopt new regulations.

•the progress, timing, costs and results of our clinical trials of our product candidates;

•the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA, or the PMDA, and other comparable foreign regulatory authorities;

•the achievement of certain development, regulatory and commercialization milestones that give rise to milestone and royalty payments to licensors;

•the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

•the cost of obtaining necessary intellectual property and defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates or any future product candidates;

•the effect of competing technological and market developments;

•the cost and timing of completion of clinical-stage and commercial-scale manufacturing activities, including costs that may result from delays in the development of a suspension-based manufacturing process by our partner, Oxford;

•the cost of establishing sales, marketing and distribution capabilities for our product candidates in regions where we choose to commercialize our products on our own; and

•the initiation, progress, timing and results of our commercialization of our product candidates, if approved for commercial sale.

•multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti-corruption laws, regulatory requirements and other governmental approvals, permits and licenses;

•failure by us or our distributors to obtain appropriate licenses or regulatory approvals for the sale or use of our product candidates, if approved, in various countries;

•difficulties in managing foreign operations;

•unexpected changes in tariffs or trade barriers;

•complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;

•financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

•reduced protection for intellectual property rights;

•reduced protection of contractual rights in the event of bankruptcy or insolvency of the other contracting party;

•natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, including the recent COVID-19 pandemic and related shelter-in-place orders, travel, social distancing and quarantine policies, boycotts, curtailment of trade and other business restrictions;

•failure to comply with foreign laws, regulations, standards and regulatory guidance governing the collection, use, disclosure, retention, security and transfer of personal data, including the European Union General Data Privacy Regulation (EU) 2016 /679 ("GDPR"); and

•failure to comply with the United Kingdom Bribery Act 2010 ("U.K. Bribery Act") and similar anti-bribery and anti-corruption laws in other jurisdictions, and the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, including by failing to maintain accurate information and control over sales and distributors’ activities.

•impairment of our business reputation and significant negative media attention;

•withdrawal of participants from our clinical trials;

•significant costs to defend related litigation;

•distraction of management’s attention from our primary business;

•substantial monetary awards to patients or other claimants;

•inability to commercialize our product candidates or any future product candidate;

•product recalls, withdrawals or labeling, marketing or promotional restrictions;

•decreased demand for our product candidates or any future product candidate, if approved for commercial sale; and

•loss of revenue.

•pre-clinical and early clinical results of any product candidates we acquire may not be predictive of future clinical results;

•potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance; or

•potential product candidates may not be effective in treating their targeted diseases.

•failure to obtain regulatory approval to commence a trial;

•unforeseen safety issues;

•determination of dosing issues;

•lack of effectiveness during clinical trials;

•inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites;

•slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial;

•changes in or modifications to clinical trial design;

•failure to manufacture or obtain supply of sufficient quantities of a gene therapy product candidate or placebo or failure to obtain sufficient quantities of concomitant medication for use in clinical trials;

•inability to monitor patients adequately during or after treatment;

•inability or unwillingness of medical investigators to follow our clinical and other applicable protocols;

•failure to establish sufficient number of clinical trial sites; or

•clinical sites or others deviating from trial protocol, inappropriately unblinding results, or dropping out of a trial.

•develop and commercialize products that are superior to other products in the market;

•demonstrate through our clinical trials that our gene therapy product candidates are differentiated from existing and future therapies;

•attract qualified scientific, product development and commercial personnel;

•obtain patent or other proprietary protection for our medicines;

•obtain required regulatory approvals;

•obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-party payors; and

•successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.

•regulatory authorities may withdraw their approval of the product or require a REMS to impose restrictions on its distribution or other risk management measures;

•regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

•we may be required to change the way the product is administered or to conduct additional clinical trials;

•we could be sued and held liable for harm caused to patients;

•we could elect to discontinue the sale of our product; and

•our reputation may suffer.

•restrictions on manufacturing such products;

•restrictions on the labeling or marketing of such products;

•restrictions on product marketing, distribution or use;

•requirements to conduct post-marketing studies or clinical trials;

•warning or untitled letters;

•withdrawal of the products from the market;

•recall of products;

•fines, restitution or disgorgement of profits or revenues;

•suspension or withdrawal of marketing approvals;

•refusal to permit the import or export of such products;

•product seizure; or

•injunctions or the imposition of civil or criminal penalties.

•the efficacy and potential advantages compared to alternative treatments;

•the effectiveness of sales and marketing efforts;

•the cost of treatment in relation to alternative treatments, including any similar generic treatments;

•our ability to offer our products for sale at competitive prices;

•the convenience and ease of administration compared to alternative treatments;

•the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•the ethical, social and legal concerns about gene therapy;

•the strength of marketing and distribution support;

•the availability of third-party coverage and adequate reimbursement and patients’ willingness to pay for our products in the absence of such coverage and adequate reimbursement;

•the prevalence and severity of any side effects; and

•any restrictions on the use of our product together with other medications.

•our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

•the inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe any drugs;

•the inability to negotiate with payors regarding reimbursement for our products; and

•unforeseen costs and expenses associated with creating an independent sales and marketing organization.

•If our product candidates are approved for commercialization, we may enter into agreements with third parties to market them in certain jurisdictions outside the United States. We expect that we will be subject to additional risks related to international operations or entering into international business relationships, including:

•different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries;

•reduced protection for intellectual property rights;

•unexpected changes in tariffs, trade barriers and regulatory requirements;

•economic weakness, including inflation, or political instability in particular foreign economies and markets;

•compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

•foreign reimbursement, pricing and insurance regimes;

•foreign taxes;

•foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

•workforce uncertainty in countries where labor unrest is more common than in the United States;

•potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and similar anti-bribery and anti-corruption laws in other jurisdictions;

•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

•business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.

•the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

•the federal false claims laws including the civil False Claims Act, which can be enforced through civil whistleblower or qui tam actions, and civil monetary penalties laws, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented to the federal government, claims for payment that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly making, or causing to be made, a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; in addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;

•HIPAA imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false or fraudulent statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on health plans, health care clearing houses, and certain health care providers, known as covered entities, and their business associates, defined as independent contractors or agents of covered entities that create, receive or obtain protected health information in connection with providing a service for or on behalf of a covered entity as well as their covered subcontractors;

•a number of federal, state and foreign laws, regulations, guidance and standards that impose requirements regarding the protection of health data that are applicable to or affect our operations;

•the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other "transfers of value" made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding their relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year; and

•analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to our business practices, including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing, as well as state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

•an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents;

•an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

•a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

•a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer point-of-sale discounts of 70% off negotiated prices of applicable brand drugs to eligible beneficiaries under their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

•extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;

•expansion of eligibility criteria for Medicaid programs in certain states;

•expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

•a licensure framework for follow on biologic products;

•a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and

•a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

•failure to satisfy their contractual duties or obligations;

•inability to meet our product specifications and quality requirements consistently;

•delay or inability to develop, procure or expand sufficient manufacturing capacity;

•manufacturing and/or product quality issues related to manufacturing development and scale-up;

•costs and validation of new equipment and facilities required for scale-up;

•failure to comply with applicable laws, regulations, and standards, including cGMP and similar foreign standards;

•deficient or improper record-keeping;

•contractual restrictions on our ability to engage additional or alternative manufacturers;

•inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

•termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

•reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates or any future product candidate in a timely fashion, in sufficient quantities or under acceptable terms;

•lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;

•lack of access or licenses to proprietary manufacturing methods used by third-party manufacturers to make our product candidates;

•operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or regulatory sanctions related to the manufacture of our or other company’s products;

•carrier disruptions or increased costs that are beyond our control; and

•failure to deliver our products under specified storage conditions and in a timely manner.

•collaborators have significant discretion in determining the amount and timing of the efforts and resources that they will apply to these collaborations;

•collaborators may not perform their obligations as expected;

•the nonclinical studies and clinical trials conducted as part of these collaborations may not be successful;

•collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on nonclinical study or clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;

•collaborators may delay nonclinical studies and clinical trials, provide insufficient funding for nonclinical studies and clinical trials, stop a nonclinical study or clinical trial or abandon a product candidate, repeat or conduct new nonclinical studies or clinical trials or require a new formulation of a product candidate for nonclinical studies or clinical trials;

•we may not have access to, or may be restricted from disclosing, certain information regarding product candidates being developed or commercialized under a collaboration and, consequently, may have limited ability to inform our stockholders about the status of such product candidates;

•collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

•product candidates developed in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;

•a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of any such product candidate;

•disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development of any product candidates, may cause delays or termination of the research, development or commercialization of such product candidates, may lead to additional responsibilities for us with respect to such product candidates or may result in litigation or arbitration, any of which would be time consuming and expensive;

•collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

•disputes may arise with respect to the ownership or inventorship of intellectual property developed pursuant to our collaborations;

•collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

•the terms of our collaboration agreement may restrict us from entering into certain relationships with other third parties, thereby limiting our options; and

•collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

•the scope of rights granted under the agreement and other interpretation-related issues;

•whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the agreement;

•our right to sublicense patent and other rights to third parties;

•our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;

•the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;

•our right to transfer or assign our license; and

•the effects of termination.

We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.

Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.

Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

We may not be able to protect our intellectual property rights throughout the world, which could impair our business.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.

Any trademarks we have obtained or may obtain may be infringed or successfully challenged, resulting in harm to our business.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

•others may be able to make products that are the same as or similar to our product candidates, but that are not covered by the claims of the patents or other intellectual property rights that we own or that we have exclusively licensed and have the right to enforce;

•we, our licensor or any collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or license;

•we or our licensor might not have been the first to file patent applications covering certain of our inventions;

•others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

•it is possible that our pending patent applications will not lead to issued patents;

•issued patents that we own or license may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;

•our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and

•we may not develop additional proprietary technologies that are patentable.

•any additional delays in the commencement, enrollment and ultimate completion of our clinical trials, including as a result of the clinical hold placed on our AXO-AAV-GM2 program that was lifted in November 2020, and manufacturing delays for our AXO-Lenti-PD program;

•results of clinical trials of our product candidates or those of our competitors;

•any delay in filing applications for marketing approval of our product candidates, and any adverse development or perceived adverse development with respect to applicable regulatory authorities’ review of those applications;

•failure to successfully develop and commercialize our product candidates;

•failure to maintain our relationship with UMMS or Oxford or comply with the terms of the UMMS Agreement or the Oxford Agreement;

•inability to obtain additional funding;

•inability to obtain, protect or maintain necessary intellectual property;

•regulatory or legal developments in the United States and other countries applicable to our product candidates, including gene therapies;

•adverse regulatory decisions or statements;

•changes in the structure of healthcare payment systems;

•inability to obtain adequate product supply for our current product candidates or any future product candidate, or the inability to do so at acceptable prices;

•introduction of new products, services or technologies by our competitors;

•failure to meet or exceed financial projections we provide to the public;

•failure to meet or exceed the estimates and projections of the investment community;

•changes in the market valuations of similar companies;

•market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;

•announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

•significant lawsuits, including patent or stockholder litigation, and disputes or other developments relating to our proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

•additions or departures of key scientific or management personnel;

•short sales of our common stock;

•sales of shares of our common stock by us or our stockholders in the future;

•negative coverage in the media or analyst reports, whether accurate or not;

•issuance of subpoenas or investigative demands, or the public fact of an investigation by a government agency, whether meritorious or not;

•trading volume of our common stock;

•general economic, industry and market conditions; and

•the other factors described in this "Risk Factors" section.

•stockholders will not be entitled to remove directors other than by a 66 2/3% vote and only for cause;

•stockholders cannot call a special meeting of stockholders;

•stockholders cannot act by written consent in lieu of a meeting; and

•stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings.

•any derivative action or proceeding brought on our behalf;

•any action asserting a breach of fiduciary duty;

•any action arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation, or our amended and restated bylaws; and

•any action asserting a claim against us that is governed by the internal-affairs doctrine.

Item 2.         Unregistered Sales of Equity Securities and Use of Proceeds

Item 3.         Defaults Upon Senior Securities.

Item 4.         Mine Safety Disclosures.

Item 5.         Other Information.

Exhibit Number

Description of Document

Form

File No.

Exhibit No.

Filing Date

3.1

Certificate of Incorporation.

8-K12G3

000-56226

3.1

11/13/2020

3.2

Bylaws.

8-K12G3

000-56226

3.2

11/13/2020

10.1*

Amended and Restated 2015 Equity Incentive Plan.

31.1*

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1*#

Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*#

Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS*

XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH*

XBRL Taxonomy Extension Schema Document.

101.CAL*

XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*

XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*

XBRL Taxonomy Extension Label Linkbase Document.

101.PRE*

XBRL Taxonomy Extension Presentation Linkbase Document.

104*

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101).

						SIO GENE THERAPIES INC.
						By:			/s/ David Nassif
Date:			November 12, 2021			Name:			David Nassif
						Title:			Chief Financial Officer and Chief Accounting Officer, General Counsel
									(Principal Financial Officer and Principal Accounting Officer)