Item 1A. Risk Factors
Item 1A. Risk
Factors.
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
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 at $14.91. 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. 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:
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●
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; and
●
general economic, industry
and market conditions.
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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 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
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. 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.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.