What changed in this filing

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Item 1A. Risk Factors

2022-11-09 compared with 2022-08-11 · 57 added, 61 removed, 94 unchanged (56% of the section changed)

ITEM 1A – RISK

There have been no material changes to the risk

factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 22, 2022,

as amended on April 28, 2022 other than as set forth below.

Risks Related to Our Financial Condition and

Capital Requirements

ITEM 1A – RISK FACTORS

There have been no material changes to the risk factors

previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 22, 2022, as amended

on April 28, 2022 other than as set forth below.

Risks Related to Our Financial Condition and Capital

We have never been profitable and may never

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With the licensing of the DNase oncology platform from

CLS in April 2022, our primary focus will be on advancing that technology through regulatory approval and commercialization, and we will

continue to incur significant research and development and other expenses related to our ongoing operations.

As a result, we have never

been profitable and we may not achieve profitability in the foreseeable future, if at all.

Our ability to generate profits in the future

will depend on a number of factors, including:

CLS in April 2022, our primary focus will be on advancing that technology via partnering opportunities or through regulatory approval

and commercialization, and we will continue to incur significant research and development and other expenses related to our ongoing operations.

As a result, we have never been profitable and we may not achieve profitability in the foreseeable future, if at all.

Our ability to generate

profits in the future will depend on a number of factors, including:

Funding the costs relating to the research and development, regulatory approval, commercialization and sale and marketing of our drug candidates and technologies;

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Our ability to raise additional capital.

As of June 30, 2022, we had an accumulated deficit

As of September 30, 2022, we had an accumulated deficit

of approximately $187.6 million.

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of our Pharmaceutical Products

Our business is substantially dependent

on the success of the DNase oncology platform.

Our business will substantially depend on the

successful clinical development, regulatory approval and commercialization of the DNase oncology platform.

It will require substantial

clinical development and regulatory approval efforts before we are permitted to commence its commercialization, if ever.

plan to continue to pursue our clinical development strategy through academic and strategic collaborations.

If we have difficulty maintaining,

obtaining, or are unable to obtain these collaborations and additional academic collaborations as planned, we may need to delay, limit

or terminate any ongoing or planned clinical development, which would have an adverse effect on our business.

The clinical trials and

manufacturing and marketing of DNase and any other product candidates will be subject to extensive and rigorous review and regulation

by numerous government authorities in the U.S., the European Union and other jurisdictions where we intend to test and, if approved, market

our product candidates.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through

preclinical testing and clinical trials that the product candidate is safe and effective for use in each target indication and potentially

in specific patient populations.

This process can take many years and may include post-marketing studies and surveillance, which would

require the expenditure of substantial resources beyond the proceeds we have currently raised.

Of the large number of drugs in development

for approval in the U.S.

and the European Union, only a small percentage successfully complete the FDA or European Medicines Agency regulatory-approval

processes, as applicable, and are commercialized.

Accordingly, even if we are able to obtain the requisite financing or identify an academic

or strategic collaboration partner to continue to fund our research, development and clinical programs, we cannot assure you that DNase

or any of our other product candidates will be successfully developed or commercialized.

Our business is substantially dependent on the

success of the DNase oncology platform.

Our business will substantially depend on the successful

clinical development, regulatory approval and commercialization of the DNase oncology platform.

It will require substantial clinical development

and regulatory approval efforts before we are permitted to commence its commercialization, if ever.

We have, and plan to continue to pursue

our clinical development strategy through academic and strategic collaborations.

If we have difficulty maintaining, obtaining, or are

unable to obtain these collaborations and additional academic collaborations as planned, we may need to delay, limit or terminate any

ongoing or planned clinical development, which would have an adverse effect on our business.

The clinical trials and manufacturing and

marketing of DNase and any other product candidates will be subject to extensive and rigorous review and regulation by numerous government

authorities in the U.S., the European Union and other jurisdictions where we intend to test and, if approved, market our product candidates.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through preclinical testing

and clinical trials that the product candidate is safe and effective for use in each target indication and potentially in specific patient

This process can take many years and may include post-marketing studies and surveillance, which would require the expenditure

of substantial resources beyond the proceeds we have currently raised.

Of the large number of drugs in development for approval in the

and the European Union, only a small percentage successfully complete the FDA or European Medicines Agency regulatory-approval processes,

as applicable, and are commercialized.

Accordingly, even if we are able to obtain the requisite financing or identify an academic or strategic

collaboration partner to continue to fund our research, development and clinical programs, we cannot assure you that DNase or any of our

other product candidates will be successfully developed or commercialized.

Risks Related to Our Reliance on Third-Parties

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and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization

Our drug candidate development programs and the

potential commercialization of our drug candidates will require substantial additional cash to fund expenses.

For some of our drug candidates,

we may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization

Our drug candidate development programs and the potential

commercialization of our drug candidates will require substantial additional cash to fund expenses.

For some of our drug candidates, we

may decide to collaborate with additional pharmaceutical and biotechnology companies for the development and potential commercialization

of those drug candidates.

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Risks Related to Our Common Stock

Our failure to meet the continued listing

requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.

Failure to regain compliance with Nasdaq listing

rules could affect the market price of our Common Stock and liquidity and reduce our ability to raise capital.

Currently, our Common Stock trades on the Nasdaq

Capital Market.

On June 3, 2022, the Company received a written notification (the “Notice”) from the Listing Qualifications

Department of the NASDAQ Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price for its common stock

had been below $1.00 for 30 consecutive business days and that the Company therefore is not in compliance with the minimum bid price requirement

for continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”).

Notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

Under the Nasdaq Listing Rules, the Company has

a period of 180 calendar days from the date of the Notice to regain compliance with the Bid Price Requirement.

Our failure to meet the continued listing requirements

of The Nasdaq Capital Market could result in a de-listing of our common stock.

Failure to regain compliance with Nasdaq listing rules

could affect the market price of our Common Stock and liquidity and reduce our ability to raise capital.

Currently, our Common Stock trades on the Nasdaq Capital

On June 3, 2022, the Company received a written notification (the “Notice”) from the Listing Qualifications Department

of the NASDAQ Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price for its common stock had been below

$1.00 for 30 consecutive business days and that the Company therefore is not in compliance with the minimum bid price requirement for

continued inclusion on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”).

has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

Under the Nasdaq Listing Rules, the Company has a

period of 180 calendar days from the date of the Notice to regain compliance with the Bid Price Requirement.

Accordingly, the Company

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period, by effecting a reverse stock split, if necessary.

The Company intends to monitor the closing bid

price of its common stock and may, if appropriate, consider available options to regain compliance with the Bid Price Requirement.

The Company intends to monitor the closing bid price

of its common stock and may, if appropriate, consider available options to regain compliance with the Bid Price Requirement.

there can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement, or will otherwise be in compliance

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may be difficult for us to raise additional capital if we are not listed on a major exchange.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

ITEM 3 – DEFAULTS UPON SENIOR

ITEM 4 – MINE SAFETY

ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES

AND USE OF PROCEEDS

ITEM 3 – DEFAULTS UPON SENIOR SECURITIES

ITEM 4 – MINE SAFETY DISCLOSURES

Not applicable.

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