What changed in this filing

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Item 1A. Risk Factors

2026-05-07 compared with 2025-11-06 · 20 added, 53 removed, 36 unchanged (67% of the section changed)

addition to the other information set forth in this Quarterly Report on Form 10-Q, consider the risk factors discussed in Part 1, “Item

Risk Factors” in the Company’s 2024 Form 10-K, filed with the SEC on March 13, 2025, the risk factors discussed in Item

1A of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, the risk factors discussed

in Item 1A of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 5, 2025 and in this

Quarterly Report on Form 10-Q, which could materially affect our business, financial condition or future results.

The risks described

in the aforementioned reports are not the only risks facing the Company.

Additional risks and uncertainties not currently known to the

Company or that it currently deems to be not material also may materially adversely affect the Company’s business, financial condition,

and/or operating results.

Risk Factors” in the Company’s 2025 Form 10-K and the risk factors discussed in Item 1A of this Quarterly Report on Form

10-Q, which could materially affect our business, financial condition or future results.

The risks described in the aforementioned reports

are not the only risks facing the Company.

Additional risks and uncertainties not currently known to the Company or that it currently

deems to be not material also may materially adversely affect the Company’s business, financial condition, and/or operating results.

following are the risk factors that have materially changed from our risk factors included in our 2025 Form 10-K:

Related to Our Business and Industry

1154 is in development and an NDA submission may not be filed, or if filed, may not be accepted by the FDA.

1154 is currently in development.

There can be no assurance as to whether the results of the clinical trials in LPCN 1154 for postpartum

depression will support an NDA submission or whether an NDA submission will be accepted for review or approved by the FDA, including

the oral route related brexanolone or its metabolites exposure profile relative to injectable brexanolone.

A safety and efficacy study

in the patient population is ongoing, however there can be no assurance that the safety and efficacy study will be completed, or that

the results from the study will meet the primary endpoint.

Further, there can be no assurance that additional studies will not be required,

and if they are required that we will have sufficient resources to conduct such additional studies to enable an NDA submission.

1154 may not achieve planned commercialization or commercialization objectives for a variety of reasons.

Commercialization

of LPCN 1154 is likely dependent on us finding a partner to market and sell LPCN 1154, if approved.

We are exploring the possibility

of partnering LPCN 1154 to a third party for commercialization, however we may not be able to identify potential partners or successfully

enter into partnership arrangements on terms favorable to us, if at all.

We cannot be certain as to whether label language required by

the FDA will require warnings, blackbox or otherwise, as to the safety or efficacy of LPCN 1154 which could negatively affect the commercialization

of LPCN 1154, if approved.

If we are unable to successfully partner or otherwise develop and get regulatory approval for LPCN 1154, LPCN

1154 may never be commercialized.

can be no assurance there will not be any third-party patent infringement proceedings against us.

Such proceedings could delay or prevent

further development of LPCN 1154.

addition, we rely on third party vendors for our supply of brexanolone, the active pharmaceutical in LPCN 1154.

If our third-party suppliers

are not able to supply brexanolone on a timely basis, or if the cost of obtaining brexanolone increases, our ability to successfully

develop and commercialize LPCN 1154 will be adversely affected.

Related to Ownership of Our Common Stock

management and directors will be able to exert influence over our affairs.

of September 30, 2025, our executive officers and directors beneficially owned approximately 6.5% of our common stock.

of March 31, 2026, our executive officers and directors beneficially owned approximately 4.7% of our common stock.

These stockholders,

30 unchanged sentences

We have incurred losses in most years since our inception.

As of September 30, 2025, we had an accumulated deficit of approximately

$207.0 million.

Substantially all of our operating losses resulted from costs incurred in connection with our research and development

programs and from general and administrative costs associated with our operations.

These losses, combined with expected future losses,

have had and will continue to have an adverse effect on our stockholders’ equity.

We expect to continue to incur significant research

and development expenses in connection with clinical trials associated with LPCN 1154, and potentially with LPCN 2101, LPCN 2401, LPCN

2203, LPCN 1148, and LPCN 1107, if further clinical trials are initiated.

As a result, we expect to continue to incur significant operating

losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2101, LPCN 2401, LPCN 2203, and possibly

LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts.

Because of the numerous risks and uncertainties

associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable,

As of March 31, 2026, we had an accumulated deficit of $213.1

Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs

and from general and administrative costs associated with our operations.

These losses, combined with expected future losses, have had

and will continue to have an adverse effect on our stockholders’ equity.

It is possible that we will continue to incur significant

research and development expenses in connection with clinical trials associated with LPCN 1154, and potentially with LPCN 2201, LPCN

2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107, if further clinical trials are initiated.

As a result, we expect to continue to

incur significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2201, LPCN

2101, LPCN 2203, LPCN 2401, and possibly LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts.

of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any

future losses or when we will become profitable, if ever.

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