What changed in this filing

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Item 1A. Risk Factors

2023-11-09 compared with 2023-08-11 · 41 added, 2 removed, 11 unchanged (80% of the section changed)

7 unchanged sentences

and results of operations.

The risks set forth in the following additional risk factors have the potential to materially affect our financial

condition and results of operations.

The risks set forth in the following additional risk factors have the potential to materially affect

our financial condition and results of operations.

need to raise additional capital to repay Investor Notes issued under a Securities Purchase Agreement dated October 23, 2023 and support

our operations.

If we are unable to raise capital in subsequent offerings, the assets we pledged to secure the lending may be taken.

believe that current cash on hand is insufficient to repay the Investor Notes and to fund operations through the end of the first quarter

If we are unable to repay the Investor Notes issued under a Securities Purchase Agreement dated October 23, 2023, the lenders

have various recourse against us, including the ability to take control of the collateral pledged to them, which constitutes substantially

all of our tangible and intangible assets, including our intellectual property.

The report of our independent registered public accounting

firm on our financial statements for the years ended December 31, 2022 and 2021 contains explanatory language that substantial doubt

exists about our ability to continue as a going concern.

We have reduced expenses because we do not have access to sufficient cash and

liquidity to finance our business operations as currently contemplated and may be compelled to reduce further general and administrative

expenses and delay clinical trials until we are able to obtain sufficient financing.

We may find it difficult to raise money on terms

favorable to us or at all.

The failure to obtain sufficient capital to support our operations would have a material adverse effect on

our business, financial condition and results of operations.

If sufficient financing is not received timely, we would then need to pursue

a plan to license or sell assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection.

we are unable to maintain compliance with the listing standards of Nasdaq, our common stock may become delisted, which could have a material

adverse effect on our ability to raise funding, which could negatively impact our business, capital and financial condition.

were not in compliance with Nasdaq listing standards and requirements for our common stock for approximately a one-year period ending

in June 2023 and had been granted an exception through June 12, 2023 to meet a number of obligations before June 12, 2023 that had been

imposed by Nasdaq.

By letter dated June 13, 2023, Nasdaq advised us that we had regained compliance.

Nasdaq requires that our common

stock have a minimum bid price of at least $1 per share (the “Minimum Bid Price”).

At the end of October 2023 and the beginning

of November 2023, the bid price for our common stock was below the Minimum Bid Price.

There can be no assurance that we will be able

to maintain compliance with all of Nasdaq’s listing requirements and standards in the future.

If we do not continue to meet all

of those obligations, our common stock could be delisted by Nasdaq.

If delisting occurs, it could be more difficult to buy or sell our

securities and to obtain accurate quotations, and the price of our common stock could suffer a material decline.

In addition, a delisting

would impair our ability to raise capital through the public markets, could deter broker-dealers from making a market in or otherwise

seeking or generating interest in our securities and might deter certain institutions and persons from investing in our securities.

of these could negatively impact our financial condition or our ability to operate our business and maintain adequate capital.

Unregistered Sales of Equity Securities and Use of Proceeds.

2 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