What changed in this filing

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Item 1A. Risk Factors

2022-11-09 compared with 2022-08-08 · 68 added, 64 removed, 73 unchanged (64% of the section changed)

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in the Company’s Annual Report filed on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 9, 2022, risk

factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 9, 2022 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 report 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.

factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 9, 2022, risk factors discussed

in Item 1A of the Form 10-Q for the quarter ended June 30, 2022 filed with the SEC on August 8, 2022, and the risk factors discussed

in Item 1A of this 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, 2021 filed with the SEC on March 9, 2022 and from our risk factors included in our Form 10-Q for the quarter ended March 31, 2022

filed with the SEC on May 9, 2022:

filed with the SEC on May 9, 2022 and from our risk factors included in our Form 10-Q for the quarter ended June 30, 2022 filed with

the SEC on August 8, 2022:

Relating to Our Business and Industry

will need to grow our Company, and we may encounter difficulties in managing this growth, which could disrupt our operations.

of June 30, 2022, we had 15 employees.

To manage our anticipated future growth, we must continue to implement and improve our managerial,

operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel.

management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial

amount of time to managing these growth activities.

Due to our limited resources, we may not be able to effectively manage the expansion

of our operations or recruit and train additional qualified personnel.

This may result in weaknesses in our infrastructure, give rise

to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees.

expansion of our operations may lead to significant costs and may divert financial resources from other projects.

If our management is

unable to effectively manage our future growth, our expenses may increase more than expected, our ability to generate revenue could be

reduced and we may not be able to implement our business strategy.

Our future financial performance and our ability to commercialize

our product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth.

of September 30, 2022, we had 17 employees.

To manage our anticipated future growth, we must continue to implement and improve our

managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified

Also, our management may need to divert a disproportionate amount of its attention away from our day-to-day activities

and devote a substantial amount of time to managing these growth activities.

Due to our limited resources, we may not be able to

effectively manage the expansion of our operations or recruit and train additional qualified personnel.

This may result in

weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced

productivity among remaining employees.

The physical expansion of our operations may lead to significant costs and may divert

financial resources from other projects.

If our management is unable to effectively manage our future growth, our expenses may

increase more than expected, our potential ability to generate revenue could be reduced and we may not be able to implement our

business strategy.

Our future financial performance and our ability to commercialize our product candidates and compete effectively

will depend, in part, on our ability to effectively manage any future growth.

Related to Ownership of Our Common Stock

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Additionally, the common stock warrants were immediately exercisable at an exercise price of $0.50 per share and expire on November 17,

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.

As of June 30, 2022, the aggregate fair value

of the warrant liability included in the Company’s consolidated balance sheet was $590,000.

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

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.

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.

As of September 30, 2022, the

aggregate fair value of the warrant liability included in the Company’s consolidated balance sheet was approximately $264,000.

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.

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 June 30, 2022, our executive officers and directors beneficially owned approximately 4.9% of our common stock.

of September 30, 2022, our executive officers and directors beneficially owned approximately 5.1% of our common stock.

These stockholders,

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

the past year, our common stock has traded as low as $0.73 and as high as $1.85 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;

past year, our common stock has traded as low as $0.39 and as high as $1.85 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;

developments generally affecting our industry;

general economic,

industry and market conditions;

general economic, industry

and market conditions;

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 customers;

regulatory action affecting our business;

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

our Annual Report.

In addition, changes in the trading price of our common stock may be inconsistent with our operating results and

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

shares of our common stock.

reports by industry

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

action affecting our business;

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

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 adversely affect investors’ ability to purchase or sell shares of our common stock.

may delist our securities from its exchange, which could harm our business and limit our stockholders ’ liquidity.

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liquidity for our securities;

determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere

to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

determination that our common stock is a “penny stock” which will require brokers

trading in our common stock to adhere to more stringent rules and possibly result in a reduced

level of trading activity in the secondary trading market for our securities;

limited amount of news and analyst coverage;

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

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

arrangements.

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 June 30, 2022, we had an accumulated deficit of $178.8

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 and working capital.

We expect our research and development

expenses to significantly increase in connection with clinical trials associated with LPCN 1148, LPCM 1111, LPCM 1144, LPCN 1107 and

NAS, if initiated.

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.

As of September 30, 2022, we had an

accumulated deficit of $181.2 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 and working

We expect our research and development expenses to significantly increase in connection with clinical trials associated

with LPCN 1154, LPCN 2101, LPCN 1148, LPCN 1111, LPCN 1144, and LPCN 1107 if and when trials are initiated.

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.

SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

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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