What changed in this filing

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Item 1A. Risk Factors

2023-11-08 compared with 2023-08-10 · 279 added, 45 removed, 81 unchanged (80% of the section changed)

2 unchanged sentences

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, risk

factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2023 filed with the SEC on May 11, 2023, and the risk factors

factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2023 filed with the SEC on May 11, 2023, and risk factors

discussed in Item 1A of the Form 10-Q for the quarter ended June 30, 2023 filed with the SEC on August 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.

5 unchanged sentences

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

Related to Our Business and Industry

to Antares’ termination of our License Agreement, we are seeking a new commercial partner for our FDA approved product TLANDO,

however there can be no guarantee that we will be able to enter into such a transaction on terms favorable to us or at all

is currently our only product that has completed Phase 3 clinical trials.

None of our other products have been approved for sale.

Therefore, at this stage, our ability to realize revenue depends substantially on TLANDO’s successful commercialization.

October 2, 2023, we received notice from Antares of Antares’ termination of the License Agreement which stated that the

License Agreement will terminate effective January 31, 2024.

As a result of the termination of the License Agreement, we do not

anticipate recognizing any future material revenue from Antares.

While we plan to seek a commercialization partner for TLANDO, there

can be no guarantee that we will be able to enter into such a transaction on terms favorable to us or at all.

March 29, 2022, the FDA granted approval to TLANDO for testosterone replacement therapy in adult males indicated for conditions associated

with a deficiency or absence of endogenous testosterone:

primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism

(congenital or acquired).

Our ability to realize royalty revenue, will depend on the commercialization efforts of Antares.

unable to find a new commercialization partner to successfully commercialize TLANDO, we may not realize any future revenue under the

Antares License Agreement and our business could be adversely affected.

Additionally, regulatory approval of TLANDO may be withdrawn

and the failure to maintain regulatory approvals would prevent TLANDO from being marketed.

the Pediatric Research Equity Act (“PREA”), the PREA requirement to assess the safety and effectiveness of TLANDO in pediatric

patients will need to be addressed.

The FDA required certain post-marketing studies including:

(i) conduct an appropriately designed

label comprehension and knowledge study that assesses patient understanding of key risk messages in the Medication Guide for TLANDO and

(ii) conduct an appropriately designed one-year trial to evaluate development of adrenal insufficiency with chronic TLANDO therapy.

studies have not yet been completed.

If we or a future licensing partner do not complete these studies, or if the results of such studies

are negative, our business, including our ability to successfully commercialize TLANDO, could be adversely affected.

the event that we seek regulatory approval of TLANDO outside the United States, such markets have requirements for approval of drug candidates

with which we must comply prior to marketing.

Obtaining regulatory approval for marketing of TLANDO in one country does not ensure we

will be able to obtain regulatory approval in other countries but a failure or delay in obtaining regulatory approval in one country

may have a negative effect on the regulatory process in other countries.

T-replacement therapies are found, or are perceived, to create health risks, our ability to realize any revenue from TLANDO and LPCN

1111 could be materially adversely affected, and our business could be harmed.

For TLANDO and LPCN 1111, if approved, physicians and

patients may be deterred from prescribing and using T-replacement therapies, which could depress demand for TLANDO and compromise the

successful commercialization of TLANDO and LPCN 1111, if approved.

publications have suggested potential health risks associated with T-replacement therapy, such as increased cardiovascular disease risk,

including increased risk of heart attack or stroke, fluid retention, sleep apnea, breast tenderness or enlargement, increased red blood

cells, development of clinical prostate disease, including prostate cancer, and the suppression of sperm production.

These potential

health risks are described in various articles, including the following publications:

2014 publication in PLOS ONE, which found that, compared to the one year prior to beginning T-replacement therapy, the risk of heart

attack doubled 90 days after the start of T deficiency treatment in older men regardless of their history of heart disease and was

two to three times higher in men younger than 65 with a history of heart disease;

2013 publication in the Journal of the American Medical Association , which reported that hypogonadal men receiving T-replacement

therapy developed a 30% increase in the risk of stroke, heart attack and death;

2013 publication in BMC Medicine, which concluded that exogenous T increased the risk of cardiovascular-related events, particularly

in trials not funded by the pharmaceutical industry.

by these events, the FDA announced on January 31, 2014, that it will investigate the risk of stroke, heart attack, and death in men taking

FDA-approved testosterone products and that the FDA would hold a T-class Advisory Committee meeting on September 17, 2014, to discuss

this topic further.

The FDA has also asked health care professionals and patients to report side effects involving prescription testosterone

products to the agency.

the FDA’s announcement, the Endocrine Society, a professional medical organization, released a statement in February 2014 in support

of further studies regarding the risks and benefits of FDA-approved T-replacement products for men with age-related T deficiency.

Specifically,

the Endocrine Society noted that large-scale randomized controlled trials are needed to determine the risks and benefits of T-replacement

therapy in older men.

In addition, the Endocrine Society recommended that patients should be informed of the potential cardiovascular

risks in middle-aged and older men associated with T-replacement therapies.

Also following the FDA’s announcement, Public Citizen,

a consumer advocacy organization, petitioned the FDA to add a “black box” warning about the increased risks of heart attacks

and other cardiovascular dangers to the product labels of all T-replacement therapies.

In addition, this petition urged the FDA to delay

its decision date on approving Aveed, a long-acting T-injectable developed by Endo, which was subsequently approved by the FDA in March

In July 2014, the FDA responded to the Public Citizen petition and denied the petition.

Additionally, in June 2014 the FDA announced

that it would require the manufacturers of testosterone drugs to update the warning label to include blood clots including deep vein

thrombosis and pulmonary embolism.

the T-class Advisory Committee meeting held on September 17, 2014, the Advisory Committee discussed (i) the identification of the

appropriate patient population for whom T-replacement therapy should be indicated and (ii) the potential risk of major adverse

cardiovascular events, defined as non-fatal stroke, non-fatal myocardial infarction and cardiovascular death associated with

T-replacement therapy.

At the meeting, 16 of the 21 members of the Advisory Committee voted that the FDA should require sponsors of

testosterone products to conduct a post marketing study (e.g.

observational study or controlled clinical trial) to further assess

the potential cardiovascular risk.

Further, 12 of these members voted that such post marketing study be required only if the

T-replacement therapy is also approved for age-related hypogonadism.

Advisory Committee also held a meeting on September 18, 2014, to evaluate the safety and efficacy of JATENZO® (previously Rextoro),

an oral TU submitted to the FDA by Clarus for the proposed indication of T-replacement therapy.

18 of the 21 members of the Advisory

Committee voted that the overall benefit/risk profile of JATENZO® was not acceptable to support approval for T-replacement therapy.

The Advisory Committee agreed that an oral TU as a T-replacement therapy is promising and that it would be of great value to patients

to have an oral treatment option, but they did not believe the current JATENZO® data supported approval.

March 3, 2015, the FDA issued a safety announcement addressing the Advisory Committee’s recommendations and communicated its expectations

related to label revisions and additional clinical requirements.

FDA’s safety assessment recommended the following label modifications/restrictions in the indicated population for T-replacement

use of T-replacement products to men who have low testosterone caused by certain medical conditions;

to initiating use of T-replacement products, confirm diagnosis of hypogonadism by ensuring that serum testosterone has been measured

in the morning on at least two separate days and that these concentrations are below the normal range;

cautionary language stating that the safety and efficacy of TRT products with age-related hypogonadism have not been established;

cautionary language stating that some studies have shown an increased risk of myocardial infarction and stroke associated with use

of T-replacement products.

March 29, 2022, the FDA approved TLANDO.

As part of their approval, the FDA required the inclusion of certain warnings and precautions

in our labeling for TLANDO, including a “black box warning,” including warnings relating to blood pressure increases and

an indication that the safety and efficacy of TLANDO in males less than 18 years has not been established.

These warnings may deter physicians

and patients from using TLANDO, which could adversely affect our business.

FDA has also required that certain post-marketing studies be conducted to (i) assess patient understanding of key risks relating to TLANDO

and (ii) evaluate development of adrenal insufficiency with chronic TLANDO therapy.

Negative outcomes from such studies could adversely

affect the successful commercialization of TLANDO, which would adversely affect our ability to realize future revenue from TLANDO.

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 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.

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

We received notice from Antares

on October 2, 2023 of Antares’ termination of the License Agreement which stated that the License Agreement will terminate

effective January 31, 2024.

As a result of the termination of the License Agreement, we do not anticipate recognizing any future

material revenue from Antares.

While we plan to seek a commercialization partner for TLANDO, there can be no guarantee that we will

be able to enter into such a transaction on terms favorable to us or at all.

Related to Our Dependence on Third Parties

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

If those collaborations, including 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 1154, LPCN 2101, LPCN 1111, LPCN 1144, LPCN 1148,

or LPCN 1107.

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

We received notice

from Antares on October 2, 2023 of Antares’ termination of the License Agreement which stated that the License Agreement will terminate

effective January 31, 2024.

As a result of the termination of the License Agreement, we do not anticipate recognizing any future material

revenue from Antares.

While we plan to seek a commercialization partner for TLANDO, there can be no guarantee that we will be able to

enter into such a transaction on terms favorable to us or at all.

intend to continue to develop our product candidates in the United States with or without a partner although our ability to advance these

product candidates will depend on our capital resources and/or our ability to find a suitable partner to further develop our product

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.

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 development 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 partners dedicate to the development or commercialization of our product candidates.

As a result, our ability to generate revenue from such arrangements will depend on the efforts of such third parties.

Our ability to generate revenues

from this and other collaborative arrangements will depend on our collaborators’ abilities and efforts to successfully perform

the functions agreed to with them in these arrangements.

License agreements and/or collaborations involving our drug candidates pose

numerous risks to us, including the following:

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

obligations as expected;

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 partners’ 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;

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;

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

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

under terms that are more economically attractive than ours;

may not be able to acquire and maintain supplier and manufacturer relationships necessary to successfully commercialize our products;

partner 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;

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 our partners 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;

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;

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

a partner 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 future licenses or collaborations we may enter into, if any, are not successful, our business, financial condition, results of

operations, prospects and development and commercialization efforts may be adversely affected.

As a result of the termination of the

License Agreement with Antares, we do not anticipate recognizing any future material revenue from Antares.

While we plan to seek a commercialization

partner for TLANDO, there can be no guarantee that we will be able to enter into such a transaction on terms favorable to us or at all.

Related to Ownership of Our Common Stock

value of our warrants outstanding from the November 2019 Offering is subject to potentially 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

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 limitations.

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.

As of June 30,

2023, there were 64,362 common stock warrants outstanding.

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 $.00017 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, 2023, there were 64,362 common stock warrants 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 June 30, 2023, the aggregate fair value

of the warrant liability included in the Company’s consolidated balance sheet was approximately $104,000.

On September 30, 2023, the aggregate fair

value of the warrant liability included in the Company’s consolidated balance sheet was approximately $29,000.

We use the Black-Scholes

7 unchanged sentences

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

of June 30, 2023, our executive officers and directors beneficially owned approximately 5.6% of our common stock.

of September 30, 2023, our executive officers and directors beneficially owned approximately 5.6% of our common stock.

These stockholders,

30 unchanged sentences

We have incurred losses in most years since our inception.

As of June 30, 2023, we had an accumulated deficit

of $190.8 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.

As of September 30, 2023, we had an accumulated

deficit of $197.5 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 and LPCN 1148, and,

subject to resource availability, for LPCN 2101, 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.

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.

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

18 unchanged sentences

adverse consequences, including:

a limited availability of market

quotations for our securities;

reduced liquidity for our securities;

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.

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.

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.

SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

UPON SENIOR SECURITIES

SAFETY DISCLOSURES

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.

Incorporation

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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contract or compensation plan or arrangement

treatment has been granted with respect to certain portions of this exhibit.

Omitted portions have been submitted separately with

the Securities and Exchange Commission

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.

November 8, 2023

Patel, President and

Executive Officer

Executive Officer and Principal Financial Officer)

November 8, 2023

Krista Fogarty

Fogarty, Corporate Controller

Accounting Officer)

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