What changed in this filing

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Item 1A. Risk Factors

2024-11-07 compared with 2024-08-08 · 47 added, 25 removed, 80 unchanged (47% of the section changed)

addition to the other information set forth in this Report, consider the risk factors discussed in Part 1, “Item 1A.

Risk Factors”

in the Company’s Annual Report filed on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, risk

factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 9, 2024, and the risk factors

discussed in Item 1A of this Form 10-Q, which could materially affect our business, financial condition or future results.

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

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

Risk Factors” in the Company’s 2023 Form 10-K, risk factors discussed in Item 1A of the 2024 March Form

10-Q, risk factors discussed in Item 1A of the 2024 June Form 10-Q, 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 Form 10-K for the year ended December

31, 2023, filed with the SEC on March 7, 2024:

following are the risk factors that have materially changed from our risk factors included in our 2023 Form 10-K:

Relating to Our Business and Industry

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may not be indicative of ultimate success in a larger Phase 2 or Phase 3 clinical study and, although we are exploring the possibility

of partnering LPCN 2401 to a third party for further development and commercialization, we may not be able to identify potential partners

of partnering LPCN 2401 with a third party for further development and commercialization, we may not be able to identify potential partners

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

We may not be able to further test in-clinic

in a timely manner or at all due to other regulatory hurdles.

In addition, LPCN 2401 in combination with incretin mimetics may not be

effective in achieving weight loss and improving body composition or may not have differentiation from competitive products on the market

or in development.

Pending resource availability, we may expend significant resources before determining that these programs are not

viable candidates for regulatory approval and commercialization.

not be able to further test in-clinic in a timely manner or at all due to other regulatory hurdles.

In addition, LPCN 2401 in combination

with incretin mimetics may not be effective in achieving weight loss and improving body composition or may not have differentiation from

competitive products on the market or in development.

Pending resource availability, we may expend significant resources before determining

that these programs are not viable candidates for regulatory approval and commercialization.

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

1154 is currently in development, and we plan to file NDA in 2024.

There can be no assurance as to whether the results of the

clinical trials or whether the planned NDA submission will be accepted for review or approved by the FDA for postpartum depression,

including, the oral route related brexanolone or its metabolites exposure profile relative to the reference injectable

Although we have an agreement with the FDA on a 505(b)(2) pathway to NDA submission, we may be required to undertake

additional clinical studie(s) including studies in the patient population since our pivotal study was conducted in post-menopausal

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

Commercialization

of LPCN 1154 is likely highly 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 effect the commercialization of the LPCN 1154, if approved.

If we are unable to successfully partner or otherwise

develop and get a regulatory approval for LPCN 1154, LPCN 1154 may never be commercialized.

current LPCN 1154 505 (b)(2) filing strategy includes referencing injectable brexanolone (Zulresso) as a listed drug.

There can be no

assurance there will not be any third party patent infringement proceedings against us.

rely on third party vendors for our supply of brexanolone, the active pharmaceutical ingredient of LPCN 1154, and on a third-party manufacturer

for the development and supply of commercial drug product of LPCN 1154.

The loss of these third-party vendors could harm the commercialization

of LPCN 1154.

Related to Ownership of Our Common Stock

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the common stock warrants were immediately exercisable at an exercise price of $8.50 per share and expire on November 17, 2024.

June 30, 2024, there were 64,362 warrants from the November 2019 offering outstanding.

September 30, 2024, there were 64,362 warrants from the November 2019 offering outstanding.

account for the common stock warrants as a derivative instrument, and changes in the fair value of the warrants are included under other

income (expense) in the Company’s statements of operations for each reporting period.

On June 30, 2024, the aggregate fair value

of the warrant liability included in the Company’s consolidated balance sheet was approximately $142,000.

On September 30, 2024, the aggregate fair

value of the warrant liability included in the Company’s consolidated balance sheet was approximately $4,000.

We use the Black-Scholes

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

of June 30, 2024, our executive officers and directors beneficially owned approximately 6.1% of our common stock.

of September 30, 2024, our executive officers and directors beneficially owned approximately 6.2% of our common stock.

These stockholders,

18 unchanged sentences

regulatory action affecting our business;

and the impact of other “Risk Factors” discussed herein and in our Annual

Report on Form 10-K filed with the SEC on March 7, 2024.

and the impact of other “Risk Factors” discussed herein and in our 2023 Form 10-K.

In addition, changes in the trading price of our common stock may be inconsistent

11 unchanged sentences

We have incurred losses in most years since our inception.

As of June 30, 2024, we had an accumulated deficit of $199.3

As of September 30, 2024, we had an accumulated deficit of $201.6

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

12 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