What changed in this filing

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Item 1A. Risk Factors

2024-08-08 compared with 2024-05-09 · 37 added, 60 removed, 68 unchanged (59% 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, 2023, filed with the SEC on March 7, 2024 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, 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

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:

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 to 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.

Related to Ownership of Our Common Stock

11 unchanged sentences

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

March 31, 2024, there were 64,362 warrants from the November 2019 offering outstanding.

June 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 March 31, 2024, the aggregate fair value

On June 30, 2024, the aggregate fair value

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

8 unchanged sentences

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

of March 31, 2024, our executive officers and directors beneficially owned approximately 6.1% of our common stock.

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

These stockholders,

33 unchanged sentences

We have incurred losses in most years since our inception.

As of March 31, 2024, we had an accumulated deficit of $196.3

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

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

1 unchanged sentence

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 to continue to incur significant

research and development expenses in connection with clinical trials associated with LPCN 1154, and potentially with LPCN 2101, LPCN

2203, LPCN 2401.

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 2101, LPCN

2203, LPCN 2401 and possibly LPCN 1148, LPCN 1144, and LPCN 1107, in addition to 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.

Incorporation

Amended and Restated Bylaws

Amendment to the Amended and Restated Bylaws of Lipocine Inc.

Amended and Restated Certificate of Incorporation

Certificate of Designation of Series A Junior Participating Preferred Stock.

Certificate of Increase of Series A Junior Participating Preferred Stock

Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Lipocine Inc.

Certificate of Designation of Series B Preferred Stock

Certificate of Amendment to the Amended and Restated Certificated of Incorporation of Lipocine Inc.

Certification

of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

Certification

of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

Certification

of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C.

Certification

of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C.

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Filed herewith

contract or compensation plan or arrangement

Confidential treatment has been granted with respect to certain

portions of this exhibit.

Omitted portions have been submitted separately with the Securities and Exchange Commission

This certification accompanies the Form 10-Q to which it relates,

is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant

under the Securities Act, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation

language contained in such filing.

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned thereunto duly authorized.

Patel, President and Chief

Executive Officer and Principal Financial Officer)

Krista Fogarty

Fogarty, Corporate Controller

Accounting Officer)

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