Lipocine Inc (LPCN)

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2026May 7, 2026 4:05 PM
PR Newswire (US) SALT LAKE CITY, May 7, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the first quarter ended March 31, 2026 and provided a corporate update. Neuroactive Steroids (NAS)LPCN 1154 for Postpartum Depression ("PPD")In April 2026, Lipocine announced topline results from its Phase 3 placebo-controlled trial (N=90) evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D (Hamilton Depression Rating Scale) total score compared to placebo at hour 60 in the full analysis set and the primary endpoint was not met.The Phase 3 results showed LPCN 1154 to be well tolerated, demonstrating a differentiated safety profile supportive of outpatient, at-home use, with no treatment-related serious adverse events, no cases of excessive sedation or loss of consciousness, and no treatment-related discontinuations.In a post hoc analysis of participants with a history of psychiatric conditions (n=54), LPCN 1154 showed statistically significant and clinically meaningful reductions in HAM-D scores versus placebo, observed as early as hour 12 and sustained through day 30.Based on these findings, Lipocine has applied for breakthrough therapy and fast track designations for LPCN 1154 in PPD and is awaiting FDA feedback.The Company intends to complete its full analysis of the Phase 3 trial data and plans to present results at upcoming medical conferences. For more information on the Phase 3 trial, refer to clinicaltrials.gov: NCT06979544.The Company is evaluating all options regarding the potential path forward for LPCN 1154. Such options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol in patients with a history of psychiatric conditions, development of other product candidates, strategic transactions, partnerships, and other opportunities.TLANDO®Lipocine has an exclusive License Agreement with Verity Pharma, entered into in 2024, under which Verity Pharma has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada, if approved.Lipocine has entered into additional license, supply and distribution agreements covering development and commercialization of TLANDO in other counties/ territories including Aché (Brazil), Pharmalink (GCC countries) and SPC (South Korea). Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries, and Brazil.First Quarter Ended March 31, 2026, Financial ResultsAs of March 31, 2026, Lipocine had $24.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.9 million at December 31, 2025.Lipocine reported a net loss of $3.7 million, or ($0.52) per diluted share, for the quarter ended March 31, 2026, compared with a net loss of $1.9 million, or ($0.35) per diluted share, for the quarter ended March 31, 2025.The company recognized royalty revenue from TLANDO sales of $119,000 during the quarter ended March 31, 2026, compared to royalty revenue of $94,000 during the quarter ended March 31, 2025.Research and development expenses were $2.8 million and $1.1 million, respectively, for the quarters ended March 31, 2026 and 2025. The increase in research and development expenses was mainly the result of an increase in costs related to our LPCN 1154 clinical study in 2026.General and administrative expenses were $1.2 million and $1.1 million, respectively, for the quarters ended March 31, 2026 and 2025. The increase in general and administrative expenses was primarily a result of an increase in various professional and consulting fees.For further details on Lipocine's financial results for the quarter ended March 31, 2026, refer to Form 10-Q filed with the SEC.About LipocineLipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.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 StatementsThis 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 the potential uses and benefits of products and product candidates, the commercial potential for product candidates, the timing of regulatory reviews and approvals and related procedures, and potential strategic 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 a 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, 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.LIPOCINE INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets(Unaudited)














March 31,
December 31,





2026
2025
Assets



Current assets:




     Cash and cash equivalents
$              5,015,608
$         5,205,842
     Marketable investment securities
19,713,463
9,724,545
     Accrued interest income
111,411
14,189
     License fee and royalties receivable
119,397
1,145,390
     Prepaid and other current assets
285,055
787,600
           Total current assets
25,244,934
16,877,566








Property and equipment, net of accumulated depreciation



 of $1,298,893 and $1,284,079 respectively
89,479
104,293Other assets
23,753
23,753
          Total assets
$            25,358,166
$       17,005,612









Liabilities and Stockholders' Equity






Current liabilities:




     Accounts payable
$              1,562,728
$           971,822
     Accrued expenses
645,115
1,236,374
     Deferred revenue
320,000
320,000
          Total current liabilities
2,527,843
2,528,196









          Total liabilities
2,527,843
2,528,196








Stockholders' equity:






     Common stock, par value $0.0001 per share, 75,000,000 




          shares authorized; 7,475,451 and 6,158,779 issued and




          7,475,115 and 6,158,443 outstanding, respectively
9,076
8,944
     Additional paid-in capital
235,937,414
223,901,106
     Treasury stock at cost, 336 shares
(40,712)
(40,712)
     Accumulated other comprehensive income
(7,194)
4,445
     Accumulated deficit
(213,068,261)
(209,396,367)
          Total stockholders' equity
22,830,323
14,477,416









         Total liabilities and stockholders' equity
$            25,358,166
$       17,005,612 LIPOCINE INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited)





Three Months Ended March 31,





2026
2025








Revenues:




Royalty revenue
119,397
93,864
     Total revenues 
119,397
93,864








Operating expenses:




Research and development
2,764,394
1,061,571
General and administrative
1,204,467
1,122,477
     Total operating expenses
3,968,861
2,184,048









     Operating loss
(3,849,464)
(2,090,184)








Other income:




Interest and investment income
177,570
225,511
     Total other income
177,570
225,511
     Loss before income tax expense
(3,671,894)
(1,864,673)








Income tax expense
-
(200)                     Net loss attributable to common shareholders
$          (3,671,894)
$         (1,864,873)








Basic loss per share attributable to common stock
$                  (0.54)
$                 (0.35)








Weighted average common shares outstanding, basic
6,795,002
5,348,557








Diluted loss per share attributable to common stock 
$                  (0.54)
$                 (0.35)








Weighted average common shares outstanding, diluted
6,795,002
5,348,557








Comprehensive loss:




Net loss
$          (3,671,894)
$         (1,864,873)
Net unrealized loss on marketable investment securities
(11,639)
(3,617)
Comprehensive loss
$          (3,683,533)
$         (1,868,490)  View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-first-quarter-ended-march-31-2026-302766140.htmlSOURCE Lipocine Inc. Original: Lipocine Announces Financial Results for the First Quarter Ended March 31, 2026

78% smackdown on "no significance" result from trial- Time for a lil lotto

LPCN under $10

Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity

LPCN under $10

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

Early Barchart Top 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

Bottom was in on the eighth

Added

Clueless

Forward split then, lol. Shelf offering! Dilution!

Yes but that is the exact opposite of a reverse split which is what you said. Reverse splits lower share count….

Increasing authorized shares can have the same end result as a split, meaning each share can be worth less, due to more shares.

Increasing authorized shares is not a reverse split ….

There is no reverse split vote!

Yes, I'm voting to reverse split.

There is no reverse split vote ….

Dilution, reverse split, recession and bankruptcy.

DRSRB!

Well, with the upcoming reverse split vote, if approved, leads to dilution, thereby pushing the stock price down.

I am amazed that LPCN is now 0.92. Testosterone replacement therapy is a large market. Will sales disappoint for a reason?

"I" am always amazed when a small cap BIO gets approval for their testosterone pill over a Big Pharma that stole it and gets nailed to cross makes their stock sink?, "I" guess girls with Testosterone and Males with LPCN so no MALES in this market/world? On Watch for some males...

This LPCN message board ROCKS!!!

In my last summary (Jan2022) the stock was under a dollar and now its looking strong, I am very bullish going forward with it. Not alot of downside ATM

28 of march TLANDO pdufa, 10th march financials, this stock may grow until the approval date and over.

28 march pdufa for TLANDO and 10th sec filling am I wrong? I think this stock is going to grow constantly until 28th of march and over.

Something, nothing, anything, everything!

You said ever thing and nothing. Perfect job done.

Yes, you are correct, in March 2022, Tlando can be marketed to the public.

I remember that March 2022 is when the exclusivity for Clarus was going to end and that we could then sell our oral testosterone pills called Tlando. That was a provisional FDA decision. Is this still the case?
Thanks

Shart!!!

If the news was good with the NASH data why is the stock flat to down?

Well the NASH news is out and the results are good.

Any time this month

When are we expecting NASH data? Thanks.

Someday this stock price will either go up or go down. I'm so glad I could help.

It's going to be a win win.

Do'h!

Actually things look pretty darn good! Lawsuit aside, our pipeline is intact & progressing. TLando will still gain full approval next March, partnership news imminent (possibly soon after A/S increase),
1144 results due in a couple months with no bad expectations... yeah I'd say things are looking pretty good!

Yes, things don't look good for Lipocine or its' investors.

https://ih.advfn.com/stock-market/NASDAQ/lipocine-LPCN/stock-news/85206412/clarus-therapeutics-defeats-lipocines-patent-infri

Quite the range today, 1.25 to 1.56.

Correction, huge volume today.

Wow, big volume today.

Not yet

Is there a date for the Clarus court case?

Do'h @ 1.38 now...
How low can she go?
She be going down~!

Are you still long on LPCN?
I Am Long.

How long have you been in LPCN?
I Came Across Lipocine in August of last year.

Do you care to share your average pps or number of shares?
I have bought and sold my holdings several times to place other trades, ultimately resulting in an increase in current shares held.

It appears that Lipocine has not interest in suing in court. What's the court status?
Court status is apparent, awaiting trial scheduling. Lipocine brought the suit against Clarus to sue in court.

I don't think Lipocine is going to get a favorable deal for marketing Tlando. Am I being too negative? When will we hear about a partnership?
It is my opinion the litigation against Clarus and/or Phase 2 1144 results would need to wrap up before a partnering announcement. However, talks are obviously ongoing per an overly excited birdy named Patel. TLando is a money maker, any partner will know that!



It is anybodys guess as to when a good catalyst will hit; analyst upgrade, pipeline news, partnership, trial, nash results, etc.. so my mention of selling to run trades is risky. But, I've been lucky with timing and I Only jump ship on damn good prospects of a daytrade or overnight hold. Long and short alike. You might try paper trading your position (no risk) to see how you do with that, then jump in sometime if you feel confident. No risk, no reward!

As for Long term vs under 12 month holds, taxes are not my concern. Profit is, and if I turn a buck into two and have to pay forty cents, I'm still sixty cents up!

G'luk

I wonder what the results of the court case are and when it will reported? Meanwhile the share price is going down, down, down, to the burning ring of fire...

It's a pretty substantial drop from 1.47 to 1.37 today. We'll see what the future holds for this.

Thanks Vance, thus far I think it's been proven that an r/s is not up for a vote, it's the dilution that's up for a vote.

Are you still long on LPCN?
How long have you been in LPCN?
Do you care to share your average pps or number of shares?

I'm not trying to be negative here, but here are some of my thoughts...

It's a shame that Tlando only got tentative approval, for marketing in March 2022, due to the fraudulent exclusivity of Jatenzo.

It appears that Lipocine has not interest in suing in court. What's the court status?

It appears that no one would want a 2 or 3 times per day Tlando pill, when Xtlando, with a once per day dose would be preferred.

It appears that no one, the FDA, patients, or big pharma has much if any interest in a T-booster pill.

I don't think Lipocine is going to get a favorable deal for marketing Tlando. Am I being too negative? When will we hear about a partnership?

Positive Nash results will be a bigger deal than Tlando, or at least a good catalyst. Unfortunately, I guess it wasn't tested on alcoholics livers, but if it treats fatty livers good, maybe it could be prescribed off label to alcoholics...

As of writing this, I'm not under water. I'm considering to bale out in full now and if I do that, I'm considering getting back in, in early 2023.

Also, the Biden Admin wants price controls/socialized medicine, which might even happen with another executive order, so lower profits for big pharma, hedge funds and us retail investors. As well as lower research capital for new drugs...

Drug costs can't just be fixed with price controls, they also need to lower NDA and SNDA costs with the FDA as well as somehow reduce the cost of drug trials.

I was under water for a,ong time on, LPCN after the FDA first reject Tlando, so I bought more and up above water now, but I mostly just see cash burning and delays here.

In the extremely long run LPCN could be a win, but if I stay in I think I'll go undwer water as the stock price tanks for the next year or so...

Am I'm being too negative and paranoid or am I being realistic. What are your thoughts?

Thank you.