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Item 9A. Controls and Procedures

2022-11-28 compared with 2021-11-24 · 62 added, 540 removed, 73 unchanged (89% of the section changed)

26 unchanged sentences

concluded that our internal controls over financial reporting were effective as of September 30, 2022.

The effectiveness of our internal control over

financial reporting as of September 30, 2022, has been audited by Grant Thornton LLP, an independent registered public accounting

firm, as stated in their report which appears in this Annual Report on Form 10-K.

Changes in Internal Control over Financial

6 unchanged sentences

EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Directors and Executive Officers

Our directors are to be elected at our

annual meeting and each director elected is to hold office until his or her successor is elected and qualified.

Our Board of Directors

may remove our officers at any time.

Our directors and executive officers,

their ages, positions held, and duration of such, are as follows:

Date first appointed

Christopher Missling, PhD

Director, President, Chief Executive Officer, Secretary

Athanasios Skarpelos

January 9, 2013

Claus van der Velden, PhD

March 2, 2018

Steffen Thomas, PhD

June 15, 2015

Peter Donhauser, D.O.

February 8, 2017

Jiong Ma, PhD

Sandra Boenisch, CPA, CGA

Principal Financial Officer, Treasurer

October 1, 2015

Business Experience

The following is a brief account of

the education and business experience of directors and executive officers during at least the past five years, indicating their

principal occupations during the period, and the names and principal businesses of the organizations by which they were employed.

Christopher Missling, PhD .

Missling has over twenty years of healthcare industry experience in big pharmaceutical, biotech industry and investment banking.

Most recently, from March 2007 until his appointment by our Company, Dr.

Missling served as the head of healthcare investment banking

at Brimberg & Co.

in New York, New York.

Missling served as the Chief Financial Officer of Curis, Inc.

(NASDAQ:CRIS)

and ImmunoGen, Inc.

(NASDAQ:IMGN).

Missling earned his MS and PhD from the University of Munich and an MBA from Northwestern

University Kellogg School of Management and WHU Otto Beisheim School of Management.

Athanasios Skarpelos .

(Tom) Skarpelos is a self-employed investor with 20 years of experience working with private and public companies with a focus

on biotechnology companies involved in drug discovery and drug development projects.

His experience has led to relationships with

researchers at academic institutes in Europe and North America.

Skarpelos is a founder of Anavex.

Claus van der Velden, PhD .

van der Velden, PhD, brings significant expertise in management, accounting, internal controls, information security and risk management.

Since May 2021, he has served as Managing Director (Chief Financial Officer) of NetCologne

GmbH, a regional telecommunication provider in Germany .

From July 2011 to May 2021, he served as corporate head of Management

Accounting, Internal Audit and Risk Management at Stroeer SE & Co KGaA, a publicly listed German digital media company.

van der Velden served as the Director of Corporate Business Controlling for the Nutrition & Health business unit at Cognis,

a worldwide supplier of global nutritional ingredients and specialty chemicals.

In this position, he was also a compliance representative

and a member of the global leadership team.

After the acquisition of Cognis by BASF, he was responsible for the management accounting

processes of the BASF Nutrition & Health division, developing and producing mostly natural-source ingredients for the food

and healthcare industries.

van der Velden started his career as a strategy consultant at an international marketing and strategy

consultancy firm.

He studied in Kiel and Stockholm and received a degree in economics from the University of Kiel and later obtained

his doctorate in business management from the WHU-Otto Beisheim School of Management where he also previously taught economics.

Steffen Thomas, PhD .

Thomas, has over 15 years of experience as a European patent attorney and is currently practicing at Epping Hermann Fischer, a

major intellectual property law firm in Europe.

Previously, he worked for Japan-based Takeda Pharmaceutical Company, the largest

pharmaceutical company in Asia and a top firm worldwide, as an in-house patent attorney.

Prior to that, he worked for Nycomed Pharma,

acquired by Takeda in 2011 for approximately USD $10 billion.

Thomas’ legal practice covers drafting of patent applications,

prosecuting patent applications before national and international patent offices, defending and challenging patents in opposition,

appeal, and nullity proceedings, enforcing patents before the infringement courts, and preparing opinions on patentability and

infringement in the technical field of chemistry.

Thomas has particular expertise in small molecule pharmaceuticals.

MS and PhD degrees in Chemistry from the University of Munich.

Peter Donhauser, D.O.

Peter Donhauser,

had more than 20 years of expertise in clinical research prior to practicing osteopathic medicine with an integrated medical approach

in private practice beginning in 2000.

He worked at the University Hospital of Munich in the fields of geriatrics and neuromusculoskeletal

During this time, he was a clinical trial investigator in multiple Phase 3 studies, including studies sponsored by Merck

Sharp & Dohme, Merck, Boehringer Mannheim, Roche, Servier and Sanofi.

He received his human medicine degree at the University

of Munich and Doctor of Osteopathic Medicine (D.O.) from the German-American Academy for Osteopathy, or DAAO, a member of the European

Jiong Ma, PhD.

Jiong Ma has over 25

years of experience in investing, building and scaling of companies with a focus on innovative product launches in digital health,

technology and the new energy transition.

Jiong Ma serves and served as a Board Director of LinkinVax, Aledia, Voxel8, Lo3

Energy, mc10, acquired by Medidata, Storiant, Fulham, Convey Computer, acquired by Micron Technology, Powervation, acquired by

RHOM Semiconductor, Laser Light Engine and Carbonite, Inc., which went public via IPO in 2011 and was subsequently acquired by

OpenText in 2019 for approximately $1.45 billion.

As a Partner at Braemar Energy Ventures, where she has worked since 2008, Dr.

Ma has focused on investments in digitization of industry, resource efficiency, mobility, renewable energy infrastructure, and

She was on the firm’s investment committee and has led more than 15 investments in growth stage companies with

focus on innovative product launches, as well as fund raising, negotiating and structuring investments, hiring management teams,

and assembling boards.

As a result of her investment experience, Dr.

Ma has significant knowledge and expertise in the technology

industry, including information security.

Prior to Braemar Energy Ventures, she was with the Venture Capital Group at 3i, a global

private equity firm, where she led investments across multiple stages in Digital Health, TMT and Cleantech.

Among them TransMedics

Group and ImpactRx/Symphony Health Solutions, which was later acquired by PRA Health Sciences.

Preceding the Venture Capital Group

Ma held several senior positions at Lucent Technologies and Bell Labs.

Her responsibilities included lead roles in product

portfolio strategy, new product launches for Optical and Data Networking, and research and product development.

a founding team member of Onetta Inc., a fiber networks company.

She has a PhD in Electrical and Computer Engineering from the

University Colorado at Boulder and an MS in Electrical Engineering from Worcester Polytechnic Institute.

Ma is a Kauffman Fellow.

Sandra Boenisch, CPA, CGA.

Boenisch is a Chartered Professional Accountant (CPA, CGA) with over 15 years of accounting, audit, and financial reporting

experience in a variety of industries, both in the United States and Canada.

Boenisch was an independent consultant, providing

financial reporting services to a range of public companies in the United States and Canada since January 2012.

From 2008 until

Boenisch was employed at BDO Canada LLP (Vancouver, BC) where she was hired as a Senior Accountant and was later promoted

to Manager, Audit Assurance.

Boenisch specialized in managing assurance engagements for public companies in the United States

Prior to that, Ms.

Boenisch worked for another public accounting firm from 2001 to 2008.

As an independent consultant,

Boenisch has acquired considerable experience in finance, governance, and regulatory compliance.

She holds a BComm from Laurentian

Family Relationships

There are no family relationships between

any director or executive officer.

Involvement in Certain Legal Proceedings

There are no material proceedings to

which any director or executive officer or any associate of any such director or officer is a party adverse to our Company or has

a material interest adverse to our Company.

Delinquent Section 16(a) Reports

Code of Ethics

We have adopted a code of ethics that

applies to our directors, principal executive officer, principal financial officer, principal accounting officer or controller,

or persons performing similar functions, and to all employees.

We have posted our policy on our website at www.anavex.com .

Audit Committee and Audit Committee Financial

The members of the Audit Committee are

Claus van der Velden (Chairman), Athanasios Skarpelos, Steffen Thomas and Jiong Ma.

Our Board of Directors has determined that

Claus van der Velden is an “audit committee financial expert” as defined by applicable SEC and Nasdaq rules.

The Audit Committee oversees and reports

to our Board of Directors on various auditing and accounting-related matters, including, among other things, the maintenance of

the integrity of our financial statements, reporting process and internal controls;

the selection, evaluation, compensation and

retention of our independent registered public accounting firm;

legal and regulatory compliance, including our disclosure controls

and procedures;

and oversight over our risk management policies and procedures.

The Audit Committee operates under a

charter that was adopted by our Board of Directors.

The Audit Committee met four times during fiscal 2021.

The Audit Committee has reviewed and

discussed the audited consolidated financial statements with management.

The Audit Committee has discussed with BDO USA, LLP the matters required to be discussed by the applicable requirements

of the Public Company Accounting Oversight Board (“PCAOB”) and the Securities and Exchange Commission (the “Commission”).

In addition, the Audit Committee has received the written disclosures and the letter from BDO USA, LLP required by applicable requirements

of the PCAOB regarding the independent accountant’s communications with the Audit Committee concerning independence, and

has discussed with BDO USA, LLP its independence from the Company and management.

Based on the reviews and discussions referred

to above, the Audit Committee recommended that the audited consolidated financial statements for the Company for the fiscal year

ended September 30, 2021 be included in this Annual Report on Form 10-K for the year ended September 30, 2021 for filing with the

MEMBERS OF THE AUDIT COMMITTEE

Claus van der Velden (Chairman)

Athanasios Skarpelos

Steffen Thomas

Nominating and Corporate Governance

The members of our Nominating and Corporate

Governance Committee are Claus van der Velden (Chairman), Steffen Thomas and Peter Donhauser.

The Nominating and Corporate Governance

Committee is appointed by the board to oversee and evaluate the Board’s performance and the Company’s compliance with

corporate governance regulations, guidelines and principles, to identify individuals qualified to become Board members, to recommend

to the Board proposed nominees for board membership, and to recommend to the Board directors to serve on each standing committee.

The Nominating and Corporate Governance Committee operates under a charter that was adopted by our Board of Directors.

The Nominating

and Corporate Governance Committee met one time during fiscal 2021.

Compensation Committee

The members of our Compensation Committee

are Claus van der Velden (Chairman), Steffen Thomas and Peter Donhauser.

The Compensation Committee assists our

Board of Directors in discharging its responsibilities relating to compensation of our directors and executive officers.

Its responsibilities

include, among other things:

reviewing, approving and recommending compensation programs and arrangements applicable to our officers;

determining the objectives of our executive officer compensation programs;

overseeing the evaluation of our senior executives;

administering our incentive compensation plans and equity-based plans, including reviewing and granting equity awards to our executive

and reviewing and approving director compensation and benefits.

The Compensation Committee can delegate to other members

of our Board of Directors, or an officer or officers of the Company, the authority to review and grant stock-based compensation

for employees who are not executive officers.

The Compensation Committee has the responsibilities

and authority designated by Nasdaq rules.

Specifically, the Compensation Committee has the sole discretion to select and receive

advice from a compensation consultant, legal counsel or other adviser and is directly responsible for oversight of their work.

The Compensation Committee must also determine reasonable compensation to be paid to such advisors by us.

The Compensation Committee operates

under a charter that was adopted by our Board of Directors.

The Compensation Committee met two times during fiscal 2021 and also

acted by written consent as required.

The Company’s compensation objectives

are to offer our executive officers’ compensation and benefits that are competitive and meet our goals of attracting, retaining

and motivating highly skilled, talented management, which is necessary for the Company to achieve its financial and strategic objectives

and create long-term value for our stockholders.

A significant portion

of the Company’s executive compensation opportunity is related to factors that directly and indirectly influence shareholder

value, including long-term stock performance and operational performance.

We believe the levels of compensation we provide should

be competitive, reasonable and appropriate for our business needs and circumstances.

Our Executive

Compensation Program and Philosophy

The intent of the Company’s compensation

program is to attract and retain talent, to create incentives for and to reward excellent performance.

We seek to compensate our

executives in a manner that is competitive, rewards performance that creates shareholder value, recognizes individual contributions,

and encourages long-term value creation.

The Compensation

Committee meets at least twice per year to review and evaluate executive compensation and each executive officer’s performance.

The Compensation Committee utilizes quantitative and qualitative factors, including the accomplishment of initiatives, attitude,

and leadership and applies overall judgment to assess performance, taking into account the financial condition of the Company.

Ultimately, the Compensation Committee seeks to evaluate, based on the achievement of financial and nonfinancial objectives,

the variable compensation, including special awards, of executive officers of the Company and decide on the base salary and target

discretionary bonus for such persons taking into account relevant benchmark data .

The Compensation Committee believes

that a significant portion of each executive’s compensation opportunity should be tied to variable compensation and value

creation for shareholders.

The Compensation Committee believes this mix provides an appropriate balance between the financial security

required to attract and retain qualified individuals, and the Compensation Committee’s goal of ensuring that executive compensation

rewards performance that benefits shareholders over the long term.

Compensation Consultants

The Compensation Committee makes recommendations

to the Board for all compensation for executives, including the structure and design of the compensation programs.

The Compensation

Committee is responsible for retaining and terminating compensation consultants and determining the terms and conditions of their

During fiscal 2021, the Compensation Committee did not engage any compensation consultants.

Annual Discretionary

The Company has an annual discretionary

cash bonus program.

The Compensation Committee, or Board of Directors works with the Chief Executive Officer to evaluate the Company’s

financial performance and overall financial condition to determine if discretionary bonuses are to be paid.

The Company’s executives are entitled

to participate in employee benefit plans, programs and arrangements implemented by the Company and generally available to all salaried

employees, such as medical, dental and insurance programs.

Executives are also allowed to participate in the Company’s tax-qualified

401(k) Plan offered to all similarly situated full-time employees.

Summary Compensation

The particulars of compensation paid

to our named executive officers for the last two completed fiscal years:

Name and Principal Position

Option Awards ($)

All other Compensation ($)

Christopher Missling, PhD

President, Chief Executive Officer, and

Sandra Boenisch (1)

Principal Financial Officer and Treasurer

(1) Compensation to Ms.

Boenisch denominated in Canadian

Dollars and has been translated to US dollars at an exchange rate of 0.7915 during the year ended September 30, 2021 (2020:

Employment Agreements

Christopher Missling

Missling entered into an

employment agreement dated July 5, 2013, as amended and extended (the “CEO Employment Agreement”), whereby we currently

Missling an annual base salary of $550,000.

In addition, Dr.

Missling is eligible to earn an annual cash bonus for each

whole or partial calendar year of up to twenty percent of his base salary, and to participate in our employee benefit plans.

have agreed to indemnify Dr.

Missling in connection with his provision of services to us.

Sandra Boenisch

Boenisch entered into an

amended and restated employment agreement dated October 4, 2017, as amended and extended, whereby we currently pay Ms.

an annual base salary of $200,000 Canadian dollars.

Boenisch is eligible for discretionary salary increases.

Outstanding Equity Awards at Fiscal Year-End

The following table sets forth for each

named executive officer and director certain information concerning the outstanding equity awards as of September 30, 2021.

Option Awards

Equity Incentive

Unexercisable

Christopher Missling

April 2, 2025

Sept 18, 2025

July 18, 2026

Sept 22, 2026

January 6, 2030

December 30, 2030

August 2, 2031

Sandra Boenisch

January 6, 2030

December 30, 2030

August 2, 2031

Compensation of Directors

The table below shows the compensation

of our directors who were not our named executive officers for the fiscal year ended September 30, 2021:

Fees Earned or Paid in Cash

Non-Equity Incentive Plan Compensation ($)

Nonqualified Deferred Compensation Earnings ($)

All Other Compensation ($)

Athanasios Skarpelos

Claus van der Velden

Steffen Thomas

Peter Donhauser

(1) At September 30, 2021, the aggregate

number of outstanding vested and unvested stock option awards held by each director was:

Skarpelos options to purchase 305,500

van der Velden options to purchase 205,500 shares, Dr.

Thomas options to purchase 305,500 shares, Dr.

Donhauser options

to purchase 205,500 shares and Dr.

Ma options to purchase 60,000 shares.

We currently compensate non-employee

directors $25,000 per year, paid quarterly, effective January 1, 2021.

We compensate Claus van der Velden an additional $4,000

per quarter for performing the functions of Chairman of our Audit Committee, Compensation Committee and Nominating and Corporate

Governance Committee.

In addition, directors are entitled

to participate in our long term incentive plans adopted by our Board of Directors and are entitled to reimbursement for reasonable

travel and other out-of-pocket expenses incurred in connection with attendance at meetings of our Board of Directors.

of Directors may award further special remuneration to any director undertaking any special services on our behalf other than services

ordinarily required of a director.

Retirement or Similar Benefit Plans

There are no arrangements or plans in

which we provide retirement or similar benefits for our directors or executive officers.

Resignation, Retirement, Other Termination,

or Change in Control Arrangements

Our Employment Agreement with Dr.

contains provisions regarding our obligations upon his termination and upon a change of control.

In the event of a change of control,

as such term is defined in the employment agreement, all previously granted but unvested stock options held by Dr.

Missling shall

Depending on the nature of the termination of Dr.

Missling’s services, certain of his salary, bonus and granted securities

shall vest in the amounts at such time as set forth in the Employment Agreement.

A copy of Dr.

Missling’s Employment Agreement

and all amendments thereto are set forth as exhibits hereto.

Our employment agreement with Sandra

Boenisch contains provisions regarding our obligations to Ms.

Boenisch upon a change of control.

In the event of a change of control,

as such term is defined in the employment agreement, all of the remaining unvested option shares granted to Ms.

Boenisch will immediately

vest with no restrictions on purchase or sales.

A copy of Ms.

Boenisch’s employment agreement is set forth in its entirety

as an exhibit hereto.

information required by this Item will be set forth in the section headed “ —Election

of Directors ” and “ Information

Regarding the Board of Directors and Corporate Governance ” in our

definitive Proxy Statement for our 2023 Annual Meeting of Stockholders to be filed with the SEC within 120 days after our year ended

September 30, 2022 (our “ Proxy Statement ” )

and is incorporated in this report by reference.

information required by this Item will be set forth in the section headed “ Executive

Compensation ” in our Proxy Statement and is incorporated in this

report by reference.

OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

The following table sets forth, as of

November 19, 2021, certain information with respect to the beneficial ownership of our common stock by each stockholder known by

us to be the beneficial owner of more than 5% of our common stock and by each of our current directors and our named executive

officers and by our current directors and executive officers as a group.

We have determined the number and percentage of shares

beneficially owned by such person in accordance with Rule 13d-3 under the Securities Exchange Act of 1934.

This information does

not necessarily indicate beneficial ownership for any other purpose.

Title of class

Name and address of

beneficial owner

Amount and nature of

beneficial ownership

Christopher Missling (CEO/Director)

6,229,644 (2)

Athanasios Skarpelos (Director)

1,586,958 (3)

Claus van der Velden (Director)

Steffen Thomas (Director)

Peter Donhauser (Director)

Jiong Ma (Director)

Sandra Boenisch (Principal Financial Officer)

Directors & Executive Officers as a group (7 persons)

*Less than 1%

(1) Percentage of ownership is based on 76,018,053 of our common stock

issued and outstanding as of November 19, 2021.

Except as otherwise indicated, we believe that the beneficial owners of the common

stock listed above, based on information furnished by such owners, have sole investment and voting power with respect to such shares,

subject to community property laws where applicable.

Beneficial ownership is determined in accordance with the rules of the Commission

and generally includes voting or investment power with respect to securities.

Shares of common stock subject to options or warrants

currently exercisable or exercisable within 60 days, are deemed outstanding for purposes of computing the percentage ownership

of the person holding such option or warrants but are not deemed outstanding for purposes of computing the percentage ownership

of any other person.

(2) Includes options to purchase 500,000 shares of our

common stock at $1.60 per share, options to purchase 73,380 shares of our common stock at $1.32 per share, options to purchase

500,000 shares of our common stock at $0.92 per share, options to purchase 187,500 shares of our common stock at $5.04 per share,

options to purchase 379,625 shares of our common stock at $6.26 per share, options to purchase 861,429 shares of our common stock

at $7.06 per share, options to purchase 500,000 shares of our common stock at $3.28 per share, options to purchase 450,000 shares

of our common stock at $5.92 per share, options to purchase 400,000 shares of our common stock at $3.30 per share, options to purchase

450,000 shares of our common stock at $2.30 per share, options to purchase 409,500 shares of our common stock at $2.58 per share,

and options to purchase 500,000 shares of our common stock at $3.15 per share that are vested or are vesting within 60 days.

options to purchase 250,000 shares of our common stock at $3.15 per share, options to purchase 550,000 shares of our common stock

at $2.96 per share, options to purchase 550,000 shares of our common stock at $5.49 per share, and options to purchase 500,000

shares of our common stock at $18.11 that do not vest within 60 days.

(3) Includes options to purchase 50,000 shares of our common stock at

$0.92 per share and options to purchase 100,000 shares of our common stock at $3.28 per share, options

to purchase 45,500 shares of our common stock at $2.58 per share , options to purchase 50,000 shares of our common stock

at $2.96 per share, and options to purchase 35,000 shares of our common stock at $5.49 per share that have vested or are vesting

within 60 days.

Excludes options to purchase 25,000 shares of our common stock at $18.11 that do not

vest within 60 days.

(4) Includes options to purchase 50,000 shares of our common

stock at $2.60 per share, options to purchase 45,500 shares of our common stock at $2.58 per share,

options to purchase 50,000 shares of our common stock at $2.96 per share, and options to purchase 35,000 shares of our common stock

at $5.49 that have vested or are vesting within 60 days .

Excludes options to purchase 25,000 shares

of our common stock at $18.11 per share that are not vesting within 60 days.

Includes options to purchase 50,000 shares of our common stock at $1.76 per share and options to purchase 100,000 shares of our common stock at $3.28 per share, options to purchase 45,500 shares of our common stock at $2.58 per share, options to purchase 50,000 shares of our common stock at $2.96 per share, and options to purchase 35,000 shares of our common stock at $5.49 per share that have vested or are vesting within 60 days.

Excludes options to purchase 25,000 shares of our common stock at $18.11 per share that are not vesting within 60 days.

Includes options to purchase 50,000 shares of our common stock at $5.39 per share, options to purchase 45,500 shares of our common stock at $2.58 per share, options to purchase 50,000 shares of our common stock at $2.96 per share, and options to purchase 35,000 shares of our common stock at $5.49 per share that have vested or are vesting within 60 days .

Excludes options to purchase 25,000 shares of our common stock at $18.11 per share that are not vesting within 60 days.

Excludes options to purchase 35,000 shares of common stock at $13.01 per share and options to purchase 25,000 shares of our

common stock at $18.11 per share that do not vest within 60 days.

Includes options to purchase 30,000 shares of our common stock at $3.30 per share, and options to purchase 30,000 shares of our common stock at $2.30 per share, options to purchase 27,300 shares of our common stock at $2.58 per share, options to purchase 35,000 shares of our common stock at $2.93 that have vested or are vesting within 60 days.

Excludes options to purchase 70,000 shares of our common stock at $2.96 per share, options to purchase 50,000 shares of our common stock at $5.49 and options to purchase 40,000 shares of our common stock at $18.11 that do not vest within 60 days.

Change in Control

We are unaware of any contract or other

arrangement, the operation of which may at a subsequent date result in a change of control of our Company.

Securities Authorized for Issuance under

Equity Compensation Plans or Individual Compensation Arrangements

The following table summarizes certain

information regarding our equity compensation plan or individual compensation arrangements at September 30, 2021:

Equity Compensation Plan Information

Plan Category

Number of securities to be issued upon exercise of outstanding options, warrants and rights

Weighted-average exercise price of outstanding options, warrants and rights

Number of securities remaining available for future issuances under equity compensation plans (excluding securities reflected in column (a))

Equity compensation plans approved by security holders

Equity compensation plans not approved by security holders

2019 Stock Option Plan

On January 15, 2019, the Board approved

the 2019 Omnibus Incentive Plan (the “2019 Plan”), which provides for the grant of stock options and restricted stock

awards to directors, officers, employees, consultants and advisors of the Company.

The 2019 Plan was approved by our stockholders

on April 5, 2019.

Under the terms of the 2019 Plan, 6,000,000

shares of Common Stock were made available for issuance[, in addition to the shares available under the 2015 Plan].

outstanding under the Company’s 2015 Omnibus Incentive Plan (the “2015 Plan”) or the Company’s 2007 Stock

Option Plan (the “2007 Plan”) will remain subject to and be paid under the 2015 Plan or the 2007 Plan, respectively,

and any shares subject to outstanding awards under the 2015 Plan or the 2007 Plan that subsequently cease to be subject to such

awards (other than by reason of settlement of the awards in shares) will automatically become available for issuance under the

The 2019 Plan provides that it may be

administered by the Board, or the Board may delegate such responsibility to a committee.

The exercise price will be determined

by the Board of Directors at the time of grant shall be at least equal to the fair market value on such date.

If the grantee is

a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s

shares of common stock on the grant date.

Stock options may be granted under the 2019 Plan for an exercise period of up to ten

years from the date of grant of the option or such lesser periods as may be determined by the board, subject to earlier termination

in accordance with the terms of the 2019 Plan.

The purpose of the 2019 Plan is to retain

the services of valued key employees and consultants of our Company and such other persons, and to encourage such persons to acquire

a greater proprietary interest in our Company, thereby strengthening their incentive to achieve the objectives of the shareholders

of our Company.

The purpose is also to serve as an aid and inducement in the hiring of new employees and to provide an equity incentive

to consultants.

information required by this Item will be set forth in the section headed “ Security

Ownership of Certain Beneficial Owners and Management ” in our Proxy

Statement and is incorporated in this report by reference.

regarding our equity compensation plans will be set forth in the section headed “ Executive

Compensation ” in our Proxy Statement and is incorporated in this

report by reference.

RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Transactions with related persons

been no transactions , since October 1, 2020, or currently proposed transactions, in which we were or are to be a participant

and the amount involved exceeds the lesser of $120,000 or one percent of the average of the smaller reporting company’s total

assets at year end for the last two completed fiscal years, and in which any of the following persons had or will have a direct

or indirect material interest.

director or executive officer of our Company;

any beneficial owner of shares carrying more than 5% of the voting

rights attached to our outstanding shares of common stock;

any member of the immediate family (including spouse, parents, children,

siblings and in-laws) of any of the foregoing persons.

Compensation of Named Executive Officers

and Directors

For information regarding compensation

of named executive officers and directors, please see “Item 11.

Executive Compensation.”

Director Independence

Under the NASDAQ Stock Market Rules, the Board

has a responsibility to make an affirmative determination that those members of its Board that serve as independent directors do

not have any relationships with the Company and its businesses that would impair their independence.

The Board has determined that

that Christopher Missling, PhD is not independent as that term is defined by NASDAQ 5605(a)(2) because Mr.

Missling serves as our

President, Chief Executive Officer, and Secretary.

The Board has determined

that that Claus van der Velden, Athanasios Skarpelos, Steffen Thomas, Peter Donhauser and Jiong

Ma are independent as that term is defined by NASDAQ 5605(a)(2) and the applicable rules of the Commission .

information required by this Item will be set forth in the section headed “ Transactions

With Related Persons ” in our Proxy Statement and is incorporated

in this report by reference.

ACCOUNTING FEES AND SERVICES

Fees Paid to Our Independent Registered

Public Accounting Firm

The following table sets forth the aggregate

fees billed or expected to be billed to our Company for professional services rendered by our independent registered public accounting

firm, for the fiscal years ended September 30, 2021 and 2020:

Audit Related Fees

All Other Fees

Consist of fees

billed for professional services rendered for the audits of our financial statements, reviews of our interim financial statements

included in quarterly reports, services performed in connection with regular filings with the Commission for the fiscal years

ended September 30, 2021 and 2020 in connection with statutory and regulatory filings or engagements.

Policy on Pre-Approval by Audit Committee

of Services Performed by Independent Registered Public Accounting Firm

Our Audit Committee pre-approves all

services provided by our independent registered public accounting firm.

All of the above services and fees were reviewed and approved

by our Audit Committee before the respective services were rendered.

Our Audit Committee has considered the

nature and amount of fees billed or expected to be billed by BDO USA, LLP and believes that the provision of services for activities

unrelated to the audit was compatible with maintaining BDO USA, LLP’s independence.

information required by this Item will be set forth in the section headed “ —Ratification

of Selection of Independent Registered Public Accounting Firm ” in

our Proxy Statement and is incorporated in this report by reference.

FINANCIAL STATEMENT SCHEDULES

of Incorporation and Bylaws

Articles of Incorporation, as amended*

Articles of Incorporation and Bylaws

Articles of Incorporation, as amended (incorporated by reference to our Annual Report on Form 10-K filed on November 24, 2021)

Bylaws (incorporated by reference to our Current Report on Form 8-K filed on September 28, 2007)

Instruments Defining the Rights of Security Holders

Description of Registrant’s Securities*

Material Contracts

2015 Omnibus Incentive Plan (incorporated by reference to our Annual Report on Form 10-K filed on December 29, 2015)

2019 Omnibus Incentive Plan (incorporated by reference to our Proxy Statement, dated February 11, 2019, as filed on February 11, 2019)

2022 Omnibus Incentive Plan (incorporated by reference to our Registration Statement on Form S-8, as filed on June 10, 2022)

Employment Agreement, dated as of July 5, 2013, by and between the Company and Christopher Missling, PhD (incorporated by reference to our Quarterly Report on Form 10-Q filed on August 13, 2014)

First Amendment to Employment Agreement, dated as of July 5, 2016, by and between the Company and Christopher Missling, PhD (incorporated by reference to our Current Report on Form 8-K filed on July 7, 2016)

Amendment to Employment Agreement, dated as of July 5, 2016, by and between the Company and Christopher Missling, PhD

(incorporated by reference to our Current Reporton Form 8-K filed on July 7, 2016)

Amended and Restated First Amendment to Employment Agreement, dated as of July 18, 2016, by and between the Company and Christopher Missling, PhD (incorporated by reference to our Current Report on Form 8-K filed on July 22, 2016)

Second Amendment to Employment Agreement, dated as of May 3, 2019 by and between the Company and Christopher Missling, PhD (incorporated by reference to our Quarterly Report on Form 10-Q filed on May 9, 2019)

Amended and Restated Employment Agreement by and between the Company and with Sandra Boenisch (incorporated by reference to our Annual Report on Form 10-K filed on December 11, 2017)

Third Amendment to Employment Agreement, dated April 7, 2022 by and between the Company and Christopher Missling, PhD (incorporated by reference to our Current Report on Form 8-K filed on April 8, 2022)

Amended and Restated Employment Agreement by and between the Company and withSandra Boenisch (incorporated by reference to our Annual Report on Form 10-K filed on December 11, 2017)

Amendment No.

1 to Amended and Restated Employment Agreement between the Company and Sandra Boenisch, dated February 4, 2020 (incorporated by reference to our Quarterly Report on Form 10-Q filed on February 6, 2020)

Amendment No.

2 to Amended and Restated Employment Agreement between the Company and Sandra Boenisch, dated February 28, 2022 (incorporated by reference to our Current Report on Form 8-K filed on March 4, 2022)

Amended and Restated Sales Agreement, dated May 1, 2020, by and among the Company, Cantor Fitzgerald & Co.

and SVB Leerink LLC (incorporated by reference to our Current Report on Form 8-K filed on May 1, 2020)

Letter Agreement, dated June 22, 2021 between the Company and H.C.

Wainwright & Co., LLC (incorporated by reference to our Current Report on Form 8-K filed on June 24, 2021)

Form of Securities Purchase Agreement, dated June 22, 2021 between the Company and the investor named therein (incorporated by reference to our Current Report on Form 8-K filed on June 24, 2021)

Exhibit Number Description

Code of Ethics

Code of Ethics Adopted on September 13, 2016 (incorporated by reference to our Annual Report on Form 10-K filed on December 14, 2016)

Subsidiaries of the Registrant

Consent of Independent Registered Public Accounting Firm

302 Certifications

Consent of Grant Thornton LLP Independent Registered Public Accounting Firm

Consent of BDO USA LLP Independent Registered Public Accounting Firm

Section 302 Certifications

Section 302 Certification of Christopher Missling, PhD.

Section 302 Certification of Sandra Boenisch

906 Certifications

Section 906 Certifications

Section 906 Certification of Christopher Missling, PhD and Sandra Boenisch

INSTANCE DOCUMENT

TAXONOMY EXTENSION SCHEMA

TAXONOMY EXTENSION CALCULATION LINKBASE

TAXONOMY EXTENSION DEFINITION LINKBASE

TAXONOMY EXTENSION LABEL LINKBASE

TAXONOMY EXTENSION PRESENTATION LINKBASE

Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

XBRL INSTANCE DOCUMENT

XBRL TAXONOMY EXTENSION SCHEMA

XBRL TAXONOMY EXTENSION CALCULATION LINKBASE

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE

XBRL TAXONOMY EXTENSION LABEL LINKBASE

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

* Filed herewith.

^ Denotes a management contract or compensatory plan

or arrangement.

^ Denotes a management contract or compensatory plan or arrangement.

Not Applicable.

6 unchanged sentences

Chief Executive Officer (Principal Executive

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf

of the registrant and in the capacities and on the dates indicated.

/s/ Christopher Missling, PhD

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the

registrant and in the capacities and on the dates indicated.

November 28, 2022

Christopher Missling,

Chief Executive Officer

(Principal Executive Officer)

/s/ Sandra Boenisch

Sandra Boenisch, CPA,

Principal Financial

Officer and Treasurer (Principal Accounting Officer)

/s/ Athanasios Skarpelos

Christopher Missling, PhD

Chief Executive Officer (Principal Executive Officer)

November 28, 2022

Sandra Boenisch, CPA, CGA

Principal Financial Officer and Treasurer (Principal

Accounting Officer)

/s/ Athanasios

November 28, 2022

Athanasios Skarpelos

/s/ Claus van der Velden, PhD

van der Velden, PhD

November 28, 2022

Claus van der Velden,

/s/ Steffen Thomas, PhD

Claus van der Velden, PhD

November 28, 2022

Steffen Thomas, PhD

/s/ Peter Donhauser, D.O.

Donhauser, D.O.

November 28, 2022

Peter Donhauser, D.O.

/s/ Jiong Ma, PhD

November 28, 2022

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures