What changed in this filing

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Item 1A. Risk Factors

2026-05-11 compared with 2026-02-06 · 7 added, 75 removed, 23 unchanged (78% of the section changed)

5 unchanged sentences

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

Risks Relating to Our Business and Industry

We rely and will continue to rely on third

parties to conduct our clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected

deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of

or commercialize 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.

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.

Our reliance on third parties to conduct clinical trials also results in

less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if we

were relying entirely upon our own employees.

Communicating with third parties can also be challenging, potentially leading to mistakes

as well as difficulties in coordinating activities.

Our business may be impacted if any of these third parties violates applicable federal,

state, or foreign laws and/or regulations, including 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.

Risks Relating To Our Common Stock

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securities in the future could have rights superior to existing stockholders.

The sale of additional shares of our Common Stock or other

securities convertible into or exchangeable for our Common Stock would dilute all of our stockholders, and if such sales of convertible

securities into or exchangeable into our Common Stock occur at a deemed issuance price that is lower than the current exercise price of

our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022 (the “Acuitas Warrants”),

the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained

within those warrants.

As of December 31, 2025, there were warrants outstanding

to purchase an aggregate of 8,282,037 shares of our Common Stock at exercise prices ranging from $0.0001 to $582.00 per share, 80,593

shares issuable upon exercise of outstanding options at exercise prices ranging from $19.00 to $4,209.00 per share and restricted stock

units totaling 2,202.

As of March 31, 2026, there were warrants outstanding

to purchase an aggregate of 8,282,037 shares (including 380,000 prefunded warrants) of our Common Stock at exercise prices ranging from

$2.50 to $582.00 per share, 2,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.31 to $774.00

per share and restricted stock units totaling 1,099.

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

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Unregistered sales of equity securities

no unregistered sales of equity securities during the three months period ended December 31, 2025.

no unregistered sales of equity securities during the three-month period ended March 31, 2026.

Defaults Upon Senior Securities

1 unchanged sentence

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