What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2023-05-11 compared with 2022-11-09 · 80 added, 90 removed, 51 unchanged (77% of the section changed)

1 unchanged sentence

Risk Factors”

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, 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.

in the Company’s Annual Report filed on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 10, 2023, 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 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.

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 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 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.

31, 2022, filed with the SEC on March 10, 2023:

Related to Ownership of Our Common Stock

11 unchanged sentences

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 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.

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 March 31, 2023, the aggregate fair value

of the warrant liability included in the Company’s consolidated balance sheet was approximately $132,000.

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

of March 31, 2023, our executive officers and directors beneficially owned approximately 5.3% of our common stock.

These stockholders,

22 unchanged sentences

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.

common stock is currently listed on the Nasdaq Capital Market (“Nasdaq”), which has qualitative and quantitative listing

However, we cannot assure you that our common stock will continue to be listed on Nasdaq in the future.

In order to continue

listing our common stock on Nasdaq, we must maintain certain financial, distribution and stock price levels.

Generally, we must maintain

a minimum amount in stockholders’ equity, a minimum number of holders of our common stock and a minimum bid price.

June 7, 2022, we received a letter from Nasdaq’s Listing Qualifications Department notifying us that we were not in compliance

with Nasdaq Listing Rule 5550(a)(2), as the minimum bid price for our listed securities was less than $1 for the previous 30 consecutive

business days.

We have a period of 180 calendar days, or until December 5, 2022, to regain compliance with the rule referred to in this

To regain compliance, the bid price of our common stock must close at $1 or more for a minimum of ten consecutive business

The notice has no present impact on the listing of our securities on Nasdaq.

the event that we do not regain compliance with the Nasdaq Listing Rules prior to the expiration of the compliance period, we will receive

written notification that our securities are subject to delisting.

At that time, we may appeal the delisting determination to a hearings

panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.

We intend to actively monitor our bid price and will

consider available options to resolve the deficiency and regain compliance with the Nasdaq Listing Rules, including considering whether

to conduct a reverse stock split.

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 2101, LPCN 1148 and LPCN

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, 2023, we had an accumulated deficit

of $187.3 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 capital.

We expect our research and

development expenses to continue to be significant in connection with clinical trials associated with LPCN 1154, LPCN 2101, LPCN 1148,

LPCN 1111, LPCN 1144, and LPCN 1107, and possibly increased research and development costs 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 1148, LPCN 1111, LPCN 1144, and LPCN 1107, and 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 at all.

may not be able to maintain our listing on the NASDAQ Capital Market, which would adversely affect the price and liquidity of our common

a small capitalization pharmaceutical company, the price of our common shares has been, and is likely to continue to be, highly volatile.

Any announcements concerning us or our competitors, clinical trial results, quarterly variations in operating results, introduction of

new products, delays in the introduction of new products or changes in product pricing policies by us or our competitors, acquisition

or loss of significant customers, partners and suppliers, changes in earnings estimates or our ratings by analysts, regulatory developments,

or fluctuations in the economy or general market conditions, among other factors, could cause the market price of our common shares to

fluctuate substantially.

There can be no assurance that the market price of our common shares will not decline below its current price

or that it will not experience significant fluctuations in the future, including fluctuations that are unrelated to our performance.

our common stock is quoted on the NASDAQ Capital Market under the symbol “LPCN”.

We must satisfy certain minimum listing

maintenance requirements to maintain the NASDAQ Capital Market quotation, including certain governance requirements and a series of financial

tests relating to stockholders’ equity or net income or market value, public float, number of market makers and stockholders, market

capitalization, and maintaining a minimum bid price of $1.00 per share.

June 7, 2022, we received a notice from the Listing Qualifications Department of The NASDAQ Stock Market stating that the bid price of

our common stock for the previous 30 consecutive trading days had closed below the minimum $1.00 per share required for continued listing

on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(a)(2).

We had a period of 180 calendar days, or until December 5, 2022, to

regain compliance with the rule.

In accordance with NASDAQ Listing Rule 5810(c)(3)(A), we provided written notice to NASDAQ of our intent

to cure the deficiency, including, if necessary, by effecting a reverse stock split and, on December 6, 2022, we received notification

from NASDAQ providing an additional 180-day grace period, until June 5, 2023, to regain compliance with the NASDAQ Marketplace Rule’s

$1.00 minimum bid price requirement.

the event that we do not regain compliance with the Nasdaq Listing Rules prior to the expiration of the compliance period, including

as a result of the reverse stock split, we will receive written notification that our securities are subject to delisting.

At that time,

we may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules.

Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities

2 unchanged sentences

adverse consequences, including:

limited availability of market quotations for our securities;

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;

limited amount of news and analyst coverage;

decreased ability to issue additional securities or obtain additional financing in the future.

a limited availability

of market quotations for our securities;

reduced liquidity for our

a 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;

a limited amount of news

and analyst coverage;

a decreased ability to

issue additional securities or obtain additional financing in the future.

National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the

4 unchanged sentences

activity, then the states can regulate or bar the sale of covered securities in a particular case.

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 1144, LPCN 1148 and LPCN 1154.

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 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

UPON SENIOR SECURITIES

SAFETY DISCLOSURES

UNREGISTERED SALES OF EQUITY SECURITIES AND USE

DEFAULTS UPON SENIOR SECURITIES

MINE SAFETY DISCLOSURES

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