What changed in this filing

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Item 1A. Risk Factors

2021-05-13 compared with 2021-02-16 · 76 added, 79 removed, 0 unchanged (100% of the section changed)

Risk Factors.

have been no material changes to the risk factors discussed in “Risk Factors” in Part I, Item 1A of our Annual Report

on Form 10-K for the fiscal year ended September 30, 2020 filed with the SEC on December 28, 2020 except for the following new

stock price has recently been volatile and may be volatile in the future.

For example, on February 1, 2021, the price of our common

stock closed at $6.53 per share while on February 9, 2021, the price of our common stock closed at $14.99 per share without disclosure

of news or other developments by us.

On February 4, 2021, the opening price of our common stock was $19.94 and the intra-day sales

price of our common stock fluctuated between a reported low sale price of $13.80 and a reported high sales price of $28.70, closing

Our volume on this day was 116,590,800, which was a substantial increase from the volume of 18,086,230 and 3,161,525

on the two days immediately preceding February 4, 2021.

We may incur rapid and substantial increases or decreases in our stock

price in the foreseeable future that are do not coincide in timing with the disclosure of news or developments by us.

market in general, and the market for biotechnology and pharmaceutical companies in particular, has experienced extreme volatility

that has often been unrelated to the operating performance of particular companies.

The market price for our common stock may

be influenced by many factors, including the following:

● announcements

of new data, clinical trial results or those of companies that are perceived to be similar

● announcements

related to any delays in any preclinical or clinical trials related to our products;

● announcements

related to our products’ ability to demonstrate efficacy or an acceptable safety

profile of our product candidates or similar announcements by companies that are perceived

to be similar to us;

ability to meet or exceed expectations of analysts or investors;

that the number of patients required for clinical trials for our drug candidates may

be larger than we anticipate, enrollment in these clinical trials may be slower than

we anticipate, participants may drop out of these clinical trials at a higher rate than

we anticipate or the duration of these clinical trials may be longer than we anticipate;

taken by regulatory agencies with respect to our product candidates or the progress of

our clinical studies, including with respect to any fast track or orphan drug designations;

● announcements

of significant acquisitions, strategic partnerships, joint ventures or capital commitments

by us, our strategic collaboration partners or our competitors;

awarded to us or companies that are perceived to be similar to us from outside entities;

in our financial results or those of companies that are perceived to be similar to us;

volume of our common stock;

● developments

concerning our collaborations or partners;

impact of the COVID-19 outbreak and its effect on us;

perception of the biotechnology or pharmaceutical industries by the public, legislatures,

regulators and the investment community;

● developments

or disputes concerning intellectual property rights;

● significant

lawsuits, including patent or stockholder litigation;

ability or inability to raise additional capital and the terms on which we raise it;

of our common stock by us or our stockholders;

in the market prices of stocks generally or of companies that are perceived to be similar

economic, industry and market conditions.

addition, companies trading in the stock market in general, and The Nasdaq Capital Market in particular, have experienced extreme

price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance.

In the past, following periods of volatility in the market, securities class-action litigation has often been instituted against

Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention

and resources, which could materially and adversely affect our business, financial condition, results of operations and growth

There can be no guarantee that our stock price will remain at current prices.

common stock may become the target of a “short squeeze.”

the past several weeks prior to the filing of this Quarterly Report on Form 10-Q, securities of certain companies have

increasingly experienced significant and extreme volatility in stock price due to short sellers of shares of common stock,

known as a “short squeeze.” These short squeezes have caused extreme volatility in those companies and in the

market and have led to the price per share of those companies to trade at a significantly inflated rate that is disconnected

from the underlying value of the company.

Many investors who have purchased shares in those companies at an inflated rate

face the risk of losing a significant portion of their original investment as the price per share has declined steadily as

interest in those stocks have abated.

There can be no assurance that we will not, in the future be, a target of a short

squeeze, and you may lose a significant portion or all of your investment if you purchase our shares at a rate that is

significantly disconnected from our underlying value.

addition to the information set forth in this Form 10-Q, you should carefully review and consider the risk factors discussed in

“Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2020 filed

with the SEC on December 28, 2020.

These risks could materially and adversely affect our business, financial condition and results

of operations.

The risks described in herein and in our Form 10-K are not the only risks we face.

Our operations could also be

affected by additional factors that are not presently known to us or by factors that we currently consider immaterial to our business.

There have been no material changes to the

risk factors discussed in “Risk Factors”

in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended

September 30, 2020 filed with the SEC on December 28, 2020 except for the following new risks:

Our stock price has recently been volatile

and may be volatile in the future.

Our stock price has recently been volatile

and may be volatile in the future.

For example, on February 1, 2021, the price of our common stock closed at $6.53 per share while

on February 9, 2021, the price of our common stock closed at $14.99 per share without disclosure of news or other developments

On February 4, 2021, the opening price of our common stock was $19.94 and the intra-day sales price of our common stock

fluctuated between a reported low sale price of $13.80 and a reported high sales price of $28.70, closing at $14.91.

on this day was 116,590,800, which was a substantial increase from the volume of 18,086,230 and 3,161,525 on the two days immediately

preceding February 4, 2021.

We may incur rapid and substantial increases or decreases in our stock price in the foreseeable future

that are do not coincide in timing with the disclosure of news or developments by us.

The stock market in general, and the market

for biotechnology and pharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated

to the operating performance of particular companies.

The market price for our common stock may be influenced by many factors,

including the following:

announcements of new data, clinical trial results or those of companies that are perceived to be similar to us;

announcements related to any delays in any preclinical or clinical trials related to our products;

announcements related to our products’

ability to demonstrate efficacy or an acceptable safety profile of our product candidates or similar announcements by companies that are perceived to be similar to us;

our ability to meet or exceed expectations of analysts or investors;

news that the number of patients required for clinical trials for our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or the duration of these clinical trials may be longer than we anticipate;

actions taken by regulatory agencies with respect to our product candidates or the progress of our clinical studies, including with respect to any fast track or orphan drug designations;

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

grants awarded to us or companies that are perceived to be similar to us from outside entities;

variations in our financial results or those of companies that are perceived to be similar to us;

trading volume of our common stock;

developments concerning our collaborations or partners;

the impact of the COVID-19 outbreak and its effect on us;

the perception of the biotechnology or pharmaceutical industries by the public, legislatures, regulators and the investment community;

developments or disputes concerning intellectual property rights;

significant lawsuits, including patent or stockholder litigation;

our ability or inability to raise additional capital and the terms on which we raise it;

sales of our common stock by us or our stockholders;

declines in the market prices of stocks generally or of companies that are perceived to be similar to us;

general economic, industry and market conditions.

In addition, companies trading in the stock

market in general, and The Nasdaq Capital Market in particular, have experienced extreme price and volume fluctuations that have

often been unrelated or disproportionate to the operating performance of these companies.

These broad market and industry factors

may seriously harm the market price of our common stock, regardless of our operating performance.

In the past, following periods

of volatility in the market, securities class-action litigation has often been instituted against companies.

Such litigation, if

instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could

materially and adversely affect our business, financial condition, results of operations and growth prospects.

There can be no

guarantee that our stock price will remain at current prices.

Our common stock may become the target

of a “short squeeze.”

In the past several weeks prior to the filing

of this Quarterly Report on Form 10-Q, securities of certain companies have increasingly experienced significant and extreme volatility

in stock price due to short sellers of shares of common stock, known as a “short squeeze.”

These short squeezes have

caused extreme volatility in those companies and in the market and have led to the price per share of those companies to trade

at a significantly inflated rate that is disconnected from the underlying value of the company.

Many investors who have purchased

shares in those companies at an inflated rate face the risk of losing a significant portion of their original investment as the

price per share has declined steadily as interest in those stocks have abated.

There can be no assurance that we will not, in the

future be, a target of a short squeeze, and you may lose a significant portion or all of your investment if you purchase our shares

at a rate that is significantly disconnected from our underlying value.

In addition to the information set forth in

this Form 10-Q, you should carefully review and consider the risk factors discussed in “Risk Factors”

in Part I, Item

1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2020 filed with the SEC on December 28, 2020.

risks could materially and adversely affect our business, financial condition and results of operations.

The risks described in

herein and in our Form 10-K are not the only risks we face.

Our operations could also be affected by additional factors that are

not presently known to us or by factors that we currently consider immaterial to our business.

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-Q

Item 1A. Risk Factors