Form 8-K

8-K — Lipocine Inc.

Accession: 0001493152-26-046060

Filed: 2026-10-07

Period: 2026-10-07

CIK: 0001535955

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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0001535955

2026-10-07

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of

The

Securities Exchange Act of 1934

Date

of Report (Date of Earliest Event Reported):

October

7, 2026

LIPOCINE

INC.

(Exact

name of registrant as specified in its charter)

Commission

File No. 001-36357

Delaware

99-0370688

(State

or other jurisdiction

incorporation)

(IRS

Employer

Identification

Number)

675

Arapeen Drive, Suite 202

Salt

Lake City, Utah 84108

(Address

of principal executive offices) (Zip Code)

Registrant’s

telephone number, including area code: (801) 994-7383

Former

name or former address, if changed since last report: Not Applicable

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions:

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, par value $0.0001 per share

LPCN

The

NASDAQ Stock Market LLC

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §

230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).

Emerging

growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

8.01

Other

Events

October 7, 2026, the Company announced that Health Canada had approved TLANDO® for testosterone replacement therapy in

adult males. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated by reference herein.

Item

9.01

Financial

Statements and Exhibits.

(d)

Exhibits

The

following exhibits are filed with this report:

Exhibit

No.

Description

99.1

Press Release Lipocine Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant

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 hereunto duly authorized.

LIPOCINE

INC.

Date:

October 7, 2026

By:

/s/

Mahesh V. Patel

Mahesh

V. Patel

President

and Chief Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Lipocine

Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy

SALT

LAKE CITY, October 7, 2026 -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of

novel oral therapeutics, today announced that, through Lipocine’s licensing partner Verity Pharmaceuticals Inc (Verity Pharma),

Health Canada has approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for the

conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). Verity Pharma holds exclusive commercial

rights to TLANDO in North America and is planning for launch and commercialization in the Canadian market by the end of 2026.

“Men

with low testosterone in Canada have been served largely by injections and topical gels, and Health Canada’s approval of TLANDO

means they will have access to a convenient oral option without needing dose titration,” said Dr. Mahesh Patel, President and Chief

Executive Officer of Lipocine. “This approval represents an important step in expanding the geographic reach of TLANDO and further

validates the value of Lipocine’s partnered commercial strategy. We look forward to supporting Verity as it prepares for launch

in Canada.”

“Health

Canada’s approval of TLANDO gives Canadian men with hypogonadism and their physicians a new oral treatment option with a simple,

fixed dosing regimen that does not require dose titration,” said Dr. Neil Flesher, Chief Medical Officer of Verity Pharma. “Starting

and managing testosterone therapy can be complicated for both patients and prescribers, and a fixed dose can make treatment easier to

start. We value our partnership with Lipocine and look forward to making TLANDO available to patients across Canada.”

Lipocine

and Verity Pharma entered into an exclusive license agreement in January 2024 under which Verity Pharma gained commercial rights to TLANDO

in the United States and Canada. Verity Pharma is responsible for regulatory and commercialization obligations in both markets and for

further development of the TLANDO franchise in North America.

The

Canadian TRT Market

than 700,000 prescriptions are written annually in Canada for TRT, and approximately 50% of this patient population is covered through

private insurance. Promotional activity surrounding currently available TRT products in Canada is limited, which Lipocine believes creates

an opportunity for TLANDO to capture a meaningful share of this large and growing market.

Intramuscular

injections hold the largest share of TRT prescriptions. Topical gels are also widely used but carry a risk of transference to others

and are messy to apply. Both injections and topical gels require titration and have been associated with compliance issues and high rates

of discontinuation. Lipocine believes a safe and effective oral therapy without a titration requirement can improve patient convenience

and compliance while eliminating the transference risk of gels and the injection site reactions associated with injectables.

About

TLANDO Canada

TLANDO

is approved by Health Canada as a testosterone replacement therapy in adult males indicated for conditions associated with a deficiency

or absence of endogenous testosterone (male hypogonadism).

IMPORTANT

SAFETY INFORMATION

TLANDO

Testosterone Undecanoate Capsules, 112.5mg, For oral use

TLANDO

should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and

if other etiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical

features and confirmed by two separate validated biochemical assays (morning testosterone) before initiating therapy with any testosterone

replacement, including TLANDO treatment.

1.1.

Pediatrics

(males < 18 years old): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric

use.

1.2.

Geriatrics

(males ≥ 65 years): There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine

whether use in the geriatric population is associated with differences in safety or effectiveness. Therefore, safety and efficacy of

TLANDO in men with age-related hypogonadism has not been established.

Contraindications

TLANDO

(testosterone undecanoate capsules) is contraindicated in:

● Patients

with known hypersensitivity to this drug or to any of its ingredients. For a complete listing

of ingredients see 6 Dosage Forms, Composition and Packaging.

● Men

with known or suspected carcinoma of the breast or prostate r (See 7 Warnings and Precautions).

● Women

and women who are pregnant. Testosterone is teratogenic and may cause fetal harm (see 16

Non-clinical Toxicology). Testosterone can cause virilization of the female fetus when administered

to a pregnant woman (see 7.1.1. Warnings and precautions, Special Populations, Pregnancy).

Warnings and Precautions

General

testosterone deficiency has not been established, testosterone replacement therapy should not be used for the treatment of sexual dysfunction.

With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary

follicle-stimulating hormone (FSH) possible leading to adverse effects on semen parameters including sperm count.

TLANDO

should not be used to attempt to improve body composition, bone and muscle mass, increase lean body mass and decrease total fat mass.

Efficacy and safety have not been established. Serious long-term deleterious health issues may arise. TLANDO has not been shown to be

safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this

drug should not be used for such purpose.

Clinical

studies have not established testosterone replacement therapy as a treatment for male infertility.

Carcinogenesis

and Genotoxicity

Prostate

Androgens

may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia (BPH). Patients receiving testosterone

replacement therapy should undergo careful and regular monitoring of the prostate gland consistent with current practices for eugonadal

men. Prior to testosterone initiation, at risk patients (those with clinical and familial factors) should be identified and all patients

must undergo a detailed examination, including the monitoring of the prostate specific antigen (PSA), in order to detect preexisting

prostatic cancer (see Monitoring and Laboratory Tests).

Geriatric

patients treated with testosterone products may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.

Breast

Patients

using long-term parenteral testosterone replacement therapy may be at an increased risk for the development of breast cancer. In men

receiving testosterone replacement therapy, careful and regular monitoring of the breast should be conducted.

Skeletal

Patients

with skeletal metastases are at risk of exacerbating hypercalcemia/ hypercalciuria with concomitant testosterone replacement therapy.

Regular monitoring of serum calcium concentrations is recommended in these patients.

Cardiovascular

Before

starting testosterone therapy, patients should be assessed for any cardiovascular risk factors (e.g., existing ischemic heart disease)

or prior history of cardiovascular events (e.g., myocardial infarction, stroke, or heart failure); ensure that blood pressure is adequately

controlled. Check blood pressure approximately 6 weeks after initiating TLANDO and periodically thereafter. Treat new-onset hypertension

or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks

in patients who develop cardiovascular risk factors or cardiovascular disease.

Cardiovascular

risk

The

results of TRAVERSE, a randomized, double-blind, placebo-controlled phase 4 clinical trial study, indicated that testosterone-replacement

therapy did not influence the incidence of major adverse cardiac events in middle-aged and older patients with hypogonadism and with

pre-existing or an increased risk of cardiovascular diseases (topical testosterone gel 7.0% vs. placebo 7.3%). However, additional adverse

reactions reported in TRAVERSE at an incidence rate >2% in either treatment group and greater in topical testosterone gel versus placebo

included: nonfatal arrythmias warranting intervention (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs

1.5%) and bone fracture (3.5% vs 2.5%). For the adverse reaction of bone fracture, each event was adjudicated by clinical review. In

the TRAVERSE Study, topical testosterone gel was associated with a higher risk of VTE (1.7% vs 1.2%) which included deep vein thrombosis

(0.6% vs 0.5%) and pulmonary embolism (0.9% vs 0.5%)

Edema

Androgens,

including TLANDO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication

in patients with pre-existing cardiac, renal, or hepatic disease. Diuretic therapy may be required, in addition to discontinuation of

the drug.

Increase

in blood pressure

Testosterone

may increase blood pressure and is not recommended in patients with uncontrolled hypertension. Based on ambulatory blood pressure monitoring

(ABPM) in Study 18-001, TLANDO increased mean systolic/diastolic BP by 4.3/1.4 mm Hg from baseline after 4 months of treatment. In patients

with hypertension on antihypertensive therapy, TLANDO increased the mean systolic/diastolic BP by 4.8/1.6 mm Hg from baseline (see 8

Adverse Reactions). Blood pressure increases can increase cardiovascular (CV) risk over time. There have been post-marketing reports

of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products.

Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute

shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with TLANDO and initiate appropriate

management.

Dependence,

Tolerance and/or Abuse Liability

TLANDO

contains testosterone undecanoate, which is a Schedule G controlled substance as defined by the Food and Drugs Act.

Testosterone

has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic

androgenic steroids. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic

steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients presenting

with serious cardiovascular or psychiatric adverse events.

Abuse

and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic

androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have

been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite

adverse events or against medical advice.

Abuse-Related

Adverse Reactions

Serious

adverse reactions have been reported in individuals who abuse anabolic androgenic steroids (with fatal outcomes in some cases) and include

cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity,

and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility

and aggression.

The

following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias,

testicular atrophy, subfertility, and infertility.

The

following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement,

breast atrophy, male-pattern baldness, and menstrual irregularities.

The

following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of

growth, and precocious puberty.

Because

these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always

possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dependence

Continued

abuse of testosterone and other anabolic steroids leading to addiction is characterized by the following behaviors:

● Taking

greater dosages than prescribed

● Continued

drug use despite medical and social problems due to drug use

● Spending

significant time to obtain the drug when supplies of the drug are interrupted

● Giving

a higher priority to drug use than other obligations

● Having

difficulty in discontinuing the drug despite desires and attempts to do so

● Experiencing

withdrawal symptoms upon abrupt discontinuation of use

Physical

dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals

taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed

mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.

Drug

dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Endocrine

and Metabolism

Androgens,

including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring

of serum calcium concentrations is recommended in these patients.

Testosterone

products have been shown to alter glucose tolerance tests. Diabetics should be followed carefully and the insulin or oral hypoglycemic

dosage adjusted accordingly.

addition, decreases in concentrations of thyroxin-binding globulins may occur, resulting in decreased total T4 serum concentrations and

increased resin uptake of triiodothyronine (T3) and thyroxine (T4). Free thyroid hormone concentrations remain unchanged, however, and

there is no clinical evidence of thyroid dysfunction.

Changes

in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy.

Genitourinary

Patients

with benign prostatic hyperplasia (BPH) may develop acute urethral obstruction. Patients should be monitored for worsening of signs and

symptoms of BPH.

Hematologic

Increases

in hematocrit levels, reflective of increases in red blood cell mass, may require lowering of dose or discontinuation of therapy. Check

hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate hematocrit 3 to 6 months after starting treatment,

and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable level. If TLANDO is restarted

and again causes hematocrit to become elevated, stop TLANDO permanently. An increase in red blood cell mass may increase the risk of

thromboembolic events.

Hepatic/Biliary/Pancreatic

Prolonged

use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse

effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal

complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. TLANDO is not a 17

alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. Nonetheless, patients

should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue TLANDO

while the cause is evaluated.

Monitoring

and Laboratory Tests

The

patient should be monitored (including serum testosterone levels) at baseline and on a regular basis to ensure adequate response to treatment.

The following laboratory tests, performed routinely, are recommended to ensure that adverse experience possibly caused by or related

to testosterone replacement therapy is detected and addressed:

● hemoglobin

and hematocrit levels should be checked periodically (to detect polycythemia);

● liver

function tests;

● prostate

specific antigen (PSA), digital rectal examination (DRE), especially if the patient presents

with progressive difficulty with urination or a change in voiding habits;

● lipid

profile, total cholesterol, LDL, HDL, and triglycerides; serum cholesterol levels may increase

and/or decrease during androgen therapy; serum prolactin levels may increase, monitor prior

and following initiation of treatment;

● diabetics

should be followed carefully and the insulin or oral hypoglycemic dosage adjusted accordingly

(see 9.4 Drug-Drug Interactions).

Reproductive

Health

● Fertility

Oligospermia

may occur after prolonged administration or excessive dosage. With large doses of exogenous androgens, including TLANDO, spermatogenesis

may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on

semen parameters including sperm count. Patients should be informed of this possible risk when deciding whether to use or to continue

to use TLANDO.

Reduced

fertility is observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also

been reported in men who abuse anabolic androgenic steroids. With either type of use, the impact on fertility may be irreversible.

● Function

Gynecomastia

may develop and persist in patients being treated for hypogonadism. Priapism or excessive sexual stimulation may develop.

testosterone deficiency has not been established, testosterone replacement therapy should not be used for the treatment of sexual dysfunction.

Respiratory

The

treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, particularly for those with risk

factors such as obesity or chronic lung diseases.

7.1.

Special Populations

7.1.1.

Pregnancy

TLANDO

is contraindicated in pregnant women and not indicated for use in females. TLANDO may cause fetal harm when administered to a pregnant

woman based on data from animal studies and its mechanism of action (see 2 Contraindications, 10 Clinical Pharmacology and 16 Nonclinical

Toxicology). Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities. Testosterone is known

to cause virilization of the external genitalia of the female fetus when administrated to pregnant women. In animal developmental studies,

exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive

tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. If a

pregnant woman is exposed to testosterone, she should be apprised of the potential hazard to the fetus (see 16 Non-Clinical Toxicology).

7.1.2.

Breastfeeding

TLANDO

should not be used in nursing women. TLANDO may cause serious adverse reactions in nursing infants. It is unknown if testosterone undecanoate

is excreted in human milk.

7.1.3.

Pediatrics

data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4.

Geriatrics

There

have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety

in those over 65 years of age differs from younger subjects. Therefore, safety and efficacy of TLANDO in men with age-related hypogonadism

has not been established.

Adverse Reactions

8.1.

Adverse Reaction Overview

Safety

of TLANDO was evaluated in Phase 1, 2, and 3 trials with treatment duration between 1 day and 52 weeks at doses of 50 to 225 mg (for

single dose studies) and between 75 and 300 mg BID (for multiple dose studies). Among the 654 patients that received TLANDO, the following

Treatment-Related Treatment Emergent Adverse Events were reported in at least 1.0% of the patients: headache (1.5%), increased hematocrit

(1.2%).

addition, testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination

with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse

reactions (see 7 Warnings and Precautions, Dependence, Tolerance and/or Abuse Liability).

8.2.

Clinical Trial Adverse Reactions

Clinical

trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect

the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information

from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

TLANDO

was evaluated in multiple clinical trials conducted in hypogonadal men, a total of 654 subjects were exposed to TLANDO, including 210

subjects who participated in a 52-week pivotal safety study, 95 subjects who participated in a pivotal efficacy study and 138 subjects

who participated in the ambulatory blood pressure monitoring (ABPM) study.

The

52-week pivotal safety study (Study 13-001) was an active controlled randomized study with dose titration in hypogonadal men, including

210 subjects receiving TLANDO and 104 receiving Health Canada approved topical gel product AndroGel 1.62% (active control arm). All subjects

started at the dose of 225 mg BID that could be increased to 300 mg BID or decreased to 150 mg BID (based on testosterone levels) after

approximately 3 and 7 weeks of treatment. Throughout the study (after week 3), between 52% and 58% of the subjects were dosed at 225

mg BID. Subject’s mean age at baseline was 53.1 years. Mean weight and BMI of subjects at baseline were 97.8 kg and 30.9 kg/m2,

respectively. Most of the subjects enrolled were white (83.8%), followed by black or African American (13.3%), while subjects of other

races comprised less than 3%.

8.3.

Less Common Clinical Trial Adverse Reactions

Blood and Lymphatic System: anemia,

blood triglyceride increased, hemoglobin increased, high density lipoprotein decreased, hypercholesterolemia, hyperlipidemia, lipids

Increased, polycythaemia, red blood cell count increased

Cardiovascular Disorders: atrial fibrillation, blood pressure increased, cardiac flutter, electrocardiogram change/abnormal, electrocardiogram

T wave inversion, enzyme level increased, heart rate increased, mitral valve incompetence, palpitations, tachycardia, tricuspid valve

incompetence, ventricular hypertrophy

Endocrine investigations: blood prolactin increased

Gastrointestinal disorders: constipation

General disorders: oedema peripheral

Hepatic System: alanine aminotransferase increased

Nervous System: dizziness, sleep apnea syndrome, tension headache, transient ischemic attack

Psychiatric System:

abnormal dreams, agitation, anxiety, insomnia, irritability, libido decreased, mood altered, panic attack, restlessness

Renal and Reproductive System: prostatic specific antigen increased, prostatitis, prostatomegaly, urinary retention

Other Potential Androgen Effects: gynaecosmastia, hirsutism, oedema

8.5.

Post-Market Adverse Reactions

The

following adverse reactions have been identified during post-approval use of testosterone replacement products. Because these reactions

are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish

a causal relationship to drug exposure.

Cardiovascular

Disorders: myocardial infarction, stroke

Vascular

Disorders: venous thromboembolism

Find

the full product monograph that is prepared for healthcare professionals and includes Patient Medication Information by visiting the

Health Canada Drug Product Database website (http://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugs-product-datebase.html);

the manufacturers website www.veritypharma.com; or by calling 1-800-977-9778

About

Lipocine

is a biopharmaceutical company developing oral therapeutics using its proprietary drug-delivery technology platform. The Company advances

product candidates addressing significant unmet medical needs and explores partnerships to support their development and commercialization.

Lipocine’s

development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder,

LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved

body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107

our candidate for prevention of preterm birth. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed

by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism,

in adult males. For more information, please visit www.lipocine.com.

Forward

Looking Statements

This

release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities

Litigation Reform Act of 1995 and include statements that are not historical facts regarding our development of our products and product

candidates and related efforts with the FDA, including the design, planned enrollment, timing and potential outcomes of the BLOOM study;

the sufficiency of existing financial and operational resources to execute the study; expected average monthly cash use, study expenditures

and cash needs; the timing of clinical trials and regulatory submissions, the potential uses and benefits of our products and product

candidates, the commercial potential for our product candidates, and potential strategic partnerships and other opportunities. Investors

are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that

we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for

our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into

partnerships or other strategic relationships to monetize our assets, safety and efficacy studies, including those relating to LPCN 1154,

may not be successful or may not provide results that would support the submission of an NDA, the FDA may not approve any of our products,

risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being

realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory

approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, variability

in enrollment and site performance, study costs exceeding current estimates, patient acceptance of Lipocine’s products, the manufacturing

and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without

limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov.

Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required

by law.

SOURCE

Lipocine Inc.

For

further information:

Krista

Fogarty

Phone:

(801) 994-7383

kf@lipocine.com

Investors:

Kelleher

Phone:

(617) 430-7579

pkelleher@lifesciadvisors.com

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- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

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dei_DocumentPeriodEndDate

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xbrli:dateItemType

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duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

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dei:submissionTypeItemType

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- Definition

Address Line 1 such as Attn, Building Name, Street Name

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No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

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- Definition

Address Line 2 such as Street or Suite number

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No definition available.

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Name:

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- Definition

Name of the City or Town

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No definition available.

+ Details

Name:

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- Definition

Code for the postal or zip code

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No definition available.

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Name:

dei_EntityAddressPostalZipCode

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dei_

Data Type:

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- Definition

Name of the state or province.

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No definition available.

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Name:

dei_EntityAddressStateOrProvince

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- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

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Data Type:

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- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

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- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

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Data Type:

dei:fileNumberItemType

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- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

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Data Type:

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- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

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- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

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Data Type:

dei:employerIdItemType

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- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

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Balance Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

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Data Type:

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

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Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

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Balance Type:

Period Type:

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

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Data Type:

dei:tradingSymbolItemType

Balance Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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