What changed in this filing

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Item 1A. Risk Factors

2021-08-12 compared with 2021-05-13 · 47 added, 29 removed, 47 unchanged (62% of the section changed)

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

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:

16 unchanged sentences

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.

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

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

6 unchanged sentences

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.

2 unchanged sentences

Our common stock may become the target

of a “short squeeze.”

In the past several weeks prior to the filing

of a “short squeeze.”

In the past several months 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

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

7 unchanged sentences

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

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.

5 unchanged sentences

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