What changed in this filing

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Item 1A. Risk Factors

2022-05-09 compared with 2021-11-10 · 54 added, 140 removed, 74 unchanged (72% of the section changed)

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Risk Factors”

in the Company’s Annual Report filed on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 11, 2021, risk

factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2021 filed with the SEC on May 6, 2021, risk factors discussed

in Item 1A of the Form 10-Q for the quarter ended June 30, 2021 filed with the SEC on August 5, 2021 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.

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, 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, 2020 filed with the SEC on March 11, 2021, from our risk factors included in our Form 10-Q for the quarter ended March 31, 2021 filed

with the SEC on May 6, 2021, and from our risk factors included in our Form 10-Q for the quarter ended June 30, 2021 filed with the SEC

on August 4, 2021.

31, 2021, filed with the SEC on March 9, 2022:

Relating to Our Business and Industry

will not be able to successfully commercialize our product candidates without establishing sales, marketing and market access capabilities

internally or through collaborators.

currently do not have a sales, marketing and market access staff.

If and when any of our product candidates are commercialized, we may

not be able to find suitable sales and marketing staff and collaborators for our product candidates.

The outside collaborators we work

with, including Antares under the Antares License Agreement with respect to TLANDO, may not be adequate or successful and any collaborators

could terminate or materially reduce the effort they direct to our products.

The development of collaborations or an internal sales force

and marketing, market access and sales capability will require significant capital, management resources and time.

The cost of establishing

such a sales force may exceed any potential product revenues and our marketing, market access and sales efforts may be unsuccessful.

If we are unable to develop an internal marketing, market access and sales capability or if we are unable to enter into a marketing and

sales arrangement with a third party on acceptable terms, we may be unable to successfully commercialize our product candidates.

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

of September 30, 2021, we had 13 employees.

of March 31, 2022, we had 13 employees.

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

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

Related to Our Dependence on Third Parties

may enter into collaborations with third parties for the development and commercialization of our drug candidates.

If those collaborations,

including, without limitation, our license arrangement with Antares for the development and commercialization of TLANDO, are not successful,

we may not be able to capitalize on the market potential of these drug candidates and may have to alter our development and commercialization

plans for our products.

drug development programs for our product candidates will require substantial additional cash to fund expenses.

We have not yet established

any collaborative arrangements relating to the development or commercialization of LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, or LPCN

We have entered into the Antares License Agreement for TLANDO with respect to TRT in the U.S.

We intend to continue to develop

our product candidates in the United States without a partner although our ability to advance these product candidates will depend on

our capital resources.

However, in order to commercialize our product candidates in the United States, we have partnered with Antares

with respect to TLANDO and we will likely look to establish a partnership or co-promotion arrangement with an established pharmaceutical

company that has a sales force, collaborate on the establishment of an internal sales force or build an internal sales force on our own

with respect to other product candidates.

We may also seek to enter into collaborative arrangements to develop and commercialize our

product candidates outside the United States.

We will face significant competition in seeking appropriate collaborators and these collaborations

are complex and time-consuming to negotiate and document.

We may not be able to negotiate collaborations on acceptable terms or in a

timely manner, or at all.

If that were to occur, we may have to curtail the development or delay commercialization of our product candidates

in certain geographies, reduce the scope of our sales or marketing activities, reduce the scope of our commercialization plans, or increase

our expenditures and undertake development or commercialization activities at our own expense.

If we elect to increase our expenditures

to fund development or commercialization activities either inside or outside of the United States on our own, we may need to obtain additional

capital, which may not be available to us on acceptable terms, or at all.

the extent we have, and if we do enter into any further such arrangements with any third parties, we will likely have limited control

over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our drug candidates.

On October 14, 2021, we entered into the Antares License Agreement with Antares, pursuant to which we granted to Antares an exclusive,

royalty-bearing, sublicensable right and license to develop and commercialize, upon final approval of TLANDO from the FDA, our TLANDO

product with respect to TRT in the U.S.

The Antares License Agreement also provides Antares with an option, exercisable on or before

March 31, 2022, to license TLANDO XR.

Consequently, our ability to generate any revenues from TLANDO with respect to TRT in the U.S.

depends on our ability to maintain our collaborations with Antares, as well as the efforts of Antares to commercialize TLANDO, once final

FDA approval is obtained.

We have limited control over the amount and timing of resources that Antares will dedicate to these efforts.

ability to generate revenues from this and other collaborative arrangements will depend on our collaborators’ abilities and efforts

to successfully perform the functions assigned to them in these arrangements.

Collaborations involving our drug candidates, such as our

collaborations with Antares, pose numerous risks to us, including the following:

collaborators

have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform

their obligations as expected;

collaborators

may de-emphasize or not pursue development and commercialization of our drug candidates or may elect not to continue or renew development

or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as

a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an

acquisition that diverts resources or creates competing priorities;

collaborators

may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate,

repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;

collaborators

could independently develop, or develop with third parties, products that compete directly or indirectly with our products or drug

candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized

under terms that are more economically attractive than ours;

collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and

distribution of our product relative to other products;

collaborators

may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and

intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize

or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property

related proceedings;

may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization

of our products or drug candidates or that result in costly litigation or arbitration that diverts management attention and resources;

collaborations

may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization

of the applicable drug candidates;

collaboration

agreements may not lead to development or commercialization of drug candidates in the most efficient manner or at all;

a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development

or commercialization program could be delayed, diminished or terminated.

our license arrangements with Antares, or any future license or collaboration we may enter into, if any, is not successful, our business,

financial condition, results of operations, prospects and development and commercialization efforts may be adversely affected.

Any termination

or expiration of the Antares License Agreement, or any future license or collaboration we may enter into, if any, could adversely affect

us financially or harm our business reputation, development and commercialization efforts.

Related to Ownership of Our Common Stock

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

At September 30, 2021, the aggregate fair

value of the warrant liability included in the Company’s consolidated balance sheet was $645,000.

On March 31, 2022, the aggregate fair value

of the warrant liability included in the Company’s consolidated balance sheet was $1.2 million.

We use the Black-Scholes option

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

of September 30, 2021, our executive officers and directors beneficially owned approximately 5.0% of our common stock.

of March 31, 2022, our executive officers and directors beneficially owned approximately 4.7% of our common stock.

These stockholders,

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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.

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

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

Relating to Our Financial Position and Capital Requirements

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foreseeable future.

have focused a significant portion of our efforts on developing TLANDO and more recently on 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.

incurred losses in most years since our inception.

As of September 30, 2021, we had an accumulated deficit of $185.3 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 significantly

increase in connection with clinical trials associated with LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154and LPCN 1107, if initiated.

a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate further clinical development

of LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, LPCN 1107 and 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.

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.

We have incurred losses in most years since our inception.

As of March 31, 2022, we had an accumulated deficit of $176.2

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, LPCN 1111, LPCN 1144, LPCN 1107, and

NAS if 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 1148, LPCN 1111, LPCN 1144, LPCN 1107, NAS and 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.

have limited shares available for issuance to raise capital to fund our operations and grant stock-based incentive awards to employees,

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we have 100,000,000 authorized shares of common stock.

As of September 30, 2021, we had 88,290,650 shares of common stock outstanding.

After taking into account the 3,915,790 shares reserved for issuance upon the exercise of outstanding options and 1,934,366 reserved

for issuance upon the exercise of outstanding warrants, as of September 30, 2021, we have a limited number of shares available for issuance.

If we are not able to increase the number of shares of common stock available for issuance, including, for example, through an amendment

to our certificate of incorporation or a reverse stock split, we will have limited shares available for issuance to raise capital to

fund our operations, make grants of stock-based incentive awards, or take such other actions requiring available capital stock needed

to operate our business.

Further delays in securing, or the failure to secure, shareholder approval of such actions, if needed, may prevent

us from executing a capital raising transaction, which may have a material adverse effect on our business and financial condition.

As of March 31, 2022, we had 88,498,924 shares of common stock outstanding.

taking into account the 6,164,105 shares reserved for issuance upon the exercise of outstanding options and shares reserved for exercise

of outstanding warrants as of March 31, 2022, we have a limited number of shares available for issuance.

We expect, from time to time,

to raise capital to fund the development of our pipeline and advance product candidates to stages that allow for approval and commercialization,

including out licensing.

Without sufficient shares available for issuance, our ability to raise capital through sales of equity is limited.

If we are not able to increase the number of shares of common stock available for issuance, we will have limited shares available for

issuance to raise capital to fund our operations, make grants of stock-based incentive awards, or take such other actions requiring available

capital stock needed to operate our business.

While we are seeking shareholder approval of an amendment to our Amended and Restated Certificate

of Incorporation of the Company to increase the number of authorized shares of common stock, there is no guarantee that we will obtain

such approval.

An increase in the number of authorized shares is key to execute our long-term strategy as we expect, from time to time,

to raise capital to fund the advancement of our product candidates to stages that allow for out licensing, allow us to remain independent

and maintain business flexibility, and create value for our shareholders If we are unable to obtain shareholder approval of the proposed

amendment, our ability to raise capital will be adversely affected.

Further delays in securing, or the failure to secure, shareholder

approval of an increase in authorized shares will prevent us from executing a capital raising transaction, which may have a material

adverse effect on our liquidity and ability to operate our business.

If we are unable to effectively raise capital, including the sale

of capital stock or other equity securities, our business and financial condition will be adversely affected.

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