What changed in this filing

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Item 1A. Risk Factors

2025-02-11 compared with 2024-11-13 · 34 added, 80 removed, 43 unchanged (73% of the section changed)

Except as described below, there have been no material

changes to the Risk Factors previously disclosed in our Form 10-K.

The risks described in our Form 10-K and below are not the only risks

facing our company.

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may

materially adversely affect our business, financial condition, and/or operating results.

There have been no material changes to the Risk Factors

previously disclosed in our 2024 Form 10-K and our quarterly report for the period ended September 30, 2024 (the “Q1 2025 10-Q”).

The risks described in our 2024 Form 10-K, our Q1 2025 10-Q and below are not the only risks facing our company.

Additional risks and

uncertainties not currently known to the Company or that we currently deem to be immaterial also may materially adversely affect our business,

financial condition, and/or operating results.

Risks Relating to Our Business and Industry

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our product candidates.

We depend, and will continue to depend, on third

parties, including, but not limited to, contract research organizations (“CROs”), clinical trial sites and clinical trial

principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials,

including those for our drug candidates bezisterim (NE3107) and BIV201.

We rely heavily on these third parties over the course of our

clinical trials, and we control only certain aspects of their activities.

Nevertheless, we retain ultimate responsibility for ensuring

that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and

regulations, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and these third parties are

required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities

for the conduct of clinical trials on product candidates in clinical development.

Regulatory authorities enforce cGCPs through periodic

inspections and for-cause inspections of clinical trial principal investigators and trial sites.

If, due to the failure of either the

Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory

requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical

trials to support our marketing applications, which would delay the regulatory approval process.

For example, our drug product candidate

bezisterim (NE3107) was cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter

study in subjects who have mild to moderate AD.

Enrollment in that trial began in August 2021, with a planned primary completion in late

2022/early 2023.

On November 29, 2023, the Company announced topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim

(NE3107) in the treatment of mild to moderate AD.

Upon trial completion, as the Company began the process of analyzing the trial data,

the Company found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were from one

geographic area).

This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites.

We subsequently

notified FDA’s OSI of such significant deviations from study protocol, the suspected improprieties, and the study sites involved.

The identification of significant deviations from study protocol and numerous GCP violations at multiple study sites raised questions

regarding the validity and robustness of data from these study sites.

The unplanned exclusion of so many patients left the trial underpowered

for its primary endpoints.

However, based on the remaining dataset from those other sites determined to be in compliance with the protocol

and GCP’s, a preliminary signal of efficacy was detected.

The Company is considering:

(1) employing the adaptive trial feature

of the protocol to continue enrolling patients to achieve statistical significance;

and/or (2) designing a new Phase 3 study of bezisterim

(NE3107) that leverages the most recent scientific literature relating to AD along with the company's understanding regarding the effects

of bezisterim (NE3107) in persons with mild-moderate AD.

We depend, and will continue to depend, on third parties,

including, but not limited to, contract research organizations (“CROs”), clinical trial sites and clinical trial principal

investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials, including

those for our drug candidates bezisterim (NE3107) and BIV201.

We rely heavily on these third parties over the course of our clinical trials,

and we control only certain aspects of their activities.

Nevertheless, we retain ultimate responsibility for ensuring that each of our

studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our

reliance on third parties does not relieve the Company of our regulatory responsibilities.

We and these third parties are required to

comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct

of clinical trials on product candidates in clinical development.

Regulatory authorities enforce cGCPs through periodic inspections and

for-cause inspections of clinical trial principal investigators and trial sites.

If, due to the failure of either the Company or a third

party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory requirements,

or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical trials to

support our marketing applications, which would delay the regulatory approval process.

Although we design the clinical trials for our product

candidates, our CROs are tasked with facilitating and monitoring these trials.

As a result, many aspects of our clinical development

programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control,

either partially or in whole.

As a result, many aspects of our clinical development programs,

including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control, either

partially or in whole.

Our reliance on third parties to conduct clinical trials also results in less direct control over the collection,

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but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws,

or provide us or government agencies with inaccurate, misleading, or incomplete data.

Adverse Developments Affecting the Financial

Services Industry and Concentration of Risk

As of September 30, 2024,

the Company had cash deposited in a certain financial institution in excess of federally insured levels.

The Company regularly monitors

the financial stability of the financial institution and believes that it is not exposed to any significant credit risk in cash and cash

Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse developments that affect financial

institutions, or concerns or rumors about such events, may lead to liquidity constraints.

In 2023, certain U.S.

government banking regulators

took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened

uncertainties in financial markets.

While previous bank failures have not had a material direct impact on the Company’s operations,

if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in

specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have

a material adverse effect on its business, financial condition and results of operations.

or provide the Company or government agencies with inaccurate, misleading, or incomplete data.

Risks Relating To Our Common Stock

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of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

As of September 30, 2024, our Articles of Incorporation,

As of December 31, 2024, our Articles of Incorporation,

as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 18,478,307 shares of Common Stock issued and 18,451,981

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within those warrants.

As of September 30, 2024, there were warrants outstanding

to purchase an aggregate of 4,316,002 shares of our Common Stock at exercise prices ranging from $1.53 to $125.00 per share and 517,996

shares issuable upon exercise of outstanding options at exercise prices ranging from $4.70 to $420.90 per share and restricted stock units

totaling 34,566.

In addition, pursuant to the Loan and Security Agreement and the Supplement to the Loan and Security Agreement, each

entered into on November 30, 2021, with Avenue Venture Opportunities Fund II, L.P.

and Avenue Venture Opportunities Fund, L.P., the lenders

have the option to convert up to $5 million of the outstanding loan amount into shares of our Common Stock at a conversion price of $69.80

As of December 31, 2024, there were warrants outstanding to purchase

an aggregate of 9,600,835 shares of our Common Stock at exercise prices ranging from $1.37 to $125.00 per share and 967,811 shares issuable

upon exercise of outstanding options at exercise prices ranging from $1.90 to $420.90 per share and restricted stock units totaling 97,067.

We may also grant additional options, warrants or equity awards.

To the extent such shares are issued, the interest of holders

of our Common Stock will be diluted.

To the extent such shares are issued, the interest of holders of our

Common Stock will be diluted.

Moreover, we are obligated to issue shares of our

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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