What changed in this filing

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Item 1A. Risk Factors

2025-05-08 compared with 2024-11-07 · 60 added, 123 removed, 4 unchanged (98% 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,

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 2023 Form 10-K:

Relating to Our Business and Industry

2401 is in a very early stage of development and may not be further developed for a variety of reasons.

2401 is in a very early stage of development and consequently the risk that we may fail to develop, commercialize, or partner LPCN 2401

and related products is high.

This development program is susceptible to technical failures in future clinical studies and regulatory

hurdles for further testing and/or meeting the FDA’s needs for NDA filing or approval.

The result of a possible POC Phase 2 study

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 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.

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

value of our warrants outstanding from the November 2019 Offering is subject to potential material increases and decreases based on fluctuations

in the price of our common stock, among other factors.

November 2019, we completed a public offering of common stock and warrants to purchase common stock (the “November 2019 Offering”).

Gross proceeds from the November 2019 Offering were approximately $6.0 million.

In the November 2019 Offering, the Company sold (i) 614,706

Class A Units, with each Class A Unit consisting of one share of common stock and a common stock warrant to purchase one share of common

stock, and (ii) 91,177 Class B Units, with each Class B Unit consisting of one pre-funded warrant to purchase one share of common stock

and one common stock warrant to purchase one share of common stock at a price of $8.50 per Class A Unit and $8.4998 per Class B Unit.

The pre-funded warrants were issued in lieu of common stock in order to ensure the purchaser did not exceed certain beneficial ownership

The pre-funded warrants were immediately exercisable at an exercise price of $0.0017 per share, subject to adjustment.

Additionally,

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

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 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

option pricing model to determine the fair value of the warrants.

As a result, the option-pricing model requires the input of several

assumptions, including the stock price volatility, share price and risk-free interest rate.

Changes in these assumptions can materially

affect the fair value estimate.

While the liability may only result from a change of control at that point in time, we ultimately may

incur amounts significantly different than the carrying value.

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

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

These stockholders,

if they act together, may be able to influence our management and affairs and all matters requiring stockholder approval, including significant

corporate transactions.

This concentration of ownership may have the effect of delaying or preventing a change in control and might affect

the market price of our common stock.

market price of our common stock has been volatile over the past year and may continue to be volatile.

market price and trading volume of our common stock has been volatile over the past year and it may continue to be volatile.

past year, our common stock has traded as low as $2.36 and as high as $10.69 per share.

We cannot predict the price at which our common

stock will trade in the future and it may decline.

The price at which our common stock trades may fluctuate significantly and may be

influenced by many factors, including our financial results;

In addition to the other information set forth in

this Quarterly Report on Form 10-Q, consider the risk factors discussed in Part 1, “Item 1A.

Risk Factors” in the Company’s

2024 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.

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.

The following are the risk factors that have materially

changed from our risk factors included in our 2024 Form 10-K:

Risks Related to Ownership of Our Common Stock

Our management and directors will be able to exert influence over

As of March 31, 2025, our executive officers and directors

beneficially owned approximately 4.2% of our common stock.

These stockholders, if they act together, may be able to influence our management

and affairs and all matters requiring stockholder approval, including significant corporate transactions.

This concentration of ownership

may have the effect of delaying or preventing a change in control and might affect the market price of our common stock.

The market price of our common stock has been volatile over the past

year and may continue to be volatile.

The market price and trading volume of our common stock

has been volatile over the past year and it may continue to be volatile.

Over the past year, our common stock has traded as low as $3.01

and as high as $10.69 per share.

We cannot predict the price at which our common stock will trade in the future and it may decline.

price at which our common stock trades may fluctuate significantly and may be influenced by many factors, including our financial results;

developments generally affecting our industry;

general economic, industry

and market conditions, and our customers;

the depth and liquidity of the market for our common stock;

general economic, industry and market conditions, and our customers;

the depth and liquidity

of the market for our common stock;

investor perceptions of our business;

reports by industry analysts;

announcements by other market participants, including, among others, investors, our competitors, and our

announcements by other market

participants, including, among others, investors, our competitors, and our customers;

regulatory action affecting our business;

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

with our operating results and outlook.

The volatility of the market price of our common stock may be inconsistent with our operating

results and outlook.

The volatility of the market price of our common stock may adversely affect investors’ ability to purchase

or sell shares of our common stock.

Relating to Our Financial Position and Capital Requirements

have incurred significant operating losses in most years since our inception and anticipate that we will incur continued losses for the

foreseeable future.

have focused a significant portion of our efforts on developing TLANDO and more recently on LPCN 1154, LPCN 1148, and LPCN 1144.

funded our operations to date through sales of our equity securities, debt and payments received under our license and collaboration

arrangements.

We have incurred losses in most years since our inception.

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

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 2401, LPCN 2101, LPCN 2203,

LPCN 1148, LPCN 1144 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 2401, LPCN 2101, LPCN 2203,

and possibly LPCN 1148, LPCN 1144, 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, if at all.

impact of other “Risk Factors” discussed herein and in our 2024 Form 10-K.

In addition, changes in the trading price of our

common stock may be inconsistent with our operating results and outlook.

The volatility of the market price of our common stock may be

inconsistent with our operating results and outlook.

The volatility of the market price of our common stock may adversely affect investors’

ability to purchase or sell shares of our common stock.

Risks Relating to Our Financial Position

and Capital Requirements

We have incurred significant operating losses in most years since

our inception and anticipate that we will incur continued losses for the foreseeable future.

We have focused a significant portion of our efforts

on developing TLANDO and more recently on LPCN 1154, LPCN 1148, and LPCN 1144.

We have funded our operations to date through sales of

our equity securities, debt and payments received under our license and collaboration arrangements.

We have incurred losses in most years

since our inception.

As of March 31, 2025, we had an accumulated deficit of $201.6 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’

We expect to continue to incur significant research and development expenses in connection with clinical trials associated with

LPCN 1154, and potentially with LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144 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 2401, LPCN 2101, LPCN 2203, and possibly LPCN 1148, LPCN 1144, 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, if at all.

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