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Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

Lipocine公佈截至2024年3月31日的第一季度財務業績
Lipocine ·  05/09 12:00

SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update.

鹽湖城,2024 年 5 月 9 日/PRNewswire/--生物製藥公司Lipocine Inc.(納斯達克股票代碼:LPCN)今天公佈了截至2024年3月31日的第一季度財務業績,並提供了公司最新情況。

LPCN 1154 for Postpartum Depression

LPCN 1154 用於產後抑鬱症

  • In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression
  • The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through the pivotal PK bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA filing
  • Topline results from the pivotal PK study are expected late in 2Q 2024. Positive results would support an NDA filing at the end of Q4 2024
  • 2024年5月,關鍵藥代動力學(PK)研究完成了受試者的給藥,該研究旨在支持LPCN 1154的新藥申請(NDA)。LPCN 1154,口服佈雷沙諾酮,正在開發用於產後抑鬱症的治療方法
  • 美國食品藥品管理局已同意Lipocine的提議,即通過505(b)(2)NDA申請通過關鍵的PK橋樑確定LPCN 1154的功效,從而獲得批准的佈雷沙諾酮靜脈輸注
  • 這項關鍵性PK研究的主要結果預計將在2024年第二季度末公佈。積極的結果將支持在2024年第四季度末提交保密協議

LPCN 1148 for Management of Cirrhosis

用於肝硬化管理的 LPCN 1148

  • In March 2024, Lipocine announced positive Week 52 results from the LPCN 1148 Phase 2 study in patients with cirrhosis. The study met primary and hepatic encephalopathy endpoints
    • Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks
    • Participants on placebo increased SMI when switched to LPCN 1148
  • Patients on LPCN 1148 therapy had fewer overt hepatic encephalopathy (OHE) events and longer time to first recurrent OHE event, with no OHE background therapy restrictions
  • LPCN 1148 was well-tolerated, with adverse events (AE) rates and severities similar to placebo. Participants on LPCN 1148 were hospitalized for fewer days
  • 2024年3月,Lipocine宣佈了針對肝硬化患者的LPCN 1148 2期研究的第52周陽性結果。該研究符合原發性和肝性腦病終點
    • 在第24周觀察到的骨骼肌指數(SMI)的上升持續了52周
    • 當改用 LPCN 1148 時,服用安慰劑的參與者增加了 SMI
  • 接受 LPCN 1148 療法的患者出現的明顯肝性腦病 (OHE) 事件較少,首次複發性肝性腦病 (OHE) 事件的時間更長,沒有 OHE 背景療法限制
  • LPCN 1148耐受性良好,不良事件(AE)發生率和嚴重程度與安慰劑相似。LPCN 1148 的參與者住院天數較少

LPCN 2401 for Obesity Management

用於肥胖管理的 LPCN 2401

  • In April 2024, Lipocine announced positive clinical results from a multi-center prospective, blinded Phase 2 study evaluating LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity
  • Results showed treatment with LPCN 2401 resulted in statistically significant body composition improvements
    • Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7%
    • Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8%
  • LPCN 2401 was well-tolerated; AEs were similar to placebo. A replay of the webcast discussing the LPCN 2401 Phase 2 results can be accessed on Lipocine's website here
  • Potential for LPCN 2401 to be used in combination with incretin mimetics (GLP-1 agonists and GLP/GIP dual agonists) for improved body composition (ameliorate muscle loss with android fat loss) or as a monotherapy post discontinuation
  • 2024年4月,Lipocine宣佈了一項多中心前瞻性、盲目的2期研究的陽性臨床結果,該研究評估了肥胖(BMI ≥30)的參與者和體重指數≥27且至少有一種體重相關合並症的參與者的LPCN 2401
  • 結果顯示,使用LPCN 2401治療可顯著改善身體成分
    • 瘦肉質量(LM)增加4.4%,脂肪量(FM)減少6.7%
    • 將安卓脂肪(AF)減少了4.1%,骨礦物質含量(BMC)增加了2.8%
  • LPCN 2401 耐受性良好;AE 與安慰劑相似。討論LPCN 2401第二階段結果的網絡直播的重播可在Lipocine的網站上觀看 這裏
  • LPCN 2401 有可能與腸促胰島素模擬劑(GLP-1 激動劑和 GLP/GIP 雙重激動劑)聯合使用,以改善身體成分(通過減少安卓脂肪改善肌肉流失),或作爲停藥後的單一療法

LPCN 2203 for Essential Tremor

針對特發性震顫的 LPCN 2203

  • Oral GABA Positive Allosteric Modulator, targeting improved efficacy with fewer side effects e.g. somnolence, dizziness
  • Daytime efficacy and improved tolerability remains an unmet need
  • Achieved relevant target blood levels with good tolerability in multiple Phase 1 studies with no incidence of somnolence, sedation or dizziness
  • 口服 GABA 陽性變構調節劑,目標是提高療效,減少副作用,例如嗜睡、頭暈
  • 日間療效和提高耐受性的需求仍未得到滿足
  • 在多項1期研究中達到了相關的目標血液水平,耐受性良好,沒有出現嗜睡、鎮靜或頭暈

TRT Franchise - TLANDO and LPCN 1111 (TLANDO XR)

TRT 特許經營權-TLANDO 和 LPCN 1111 (TLANDO XR)

  • In January 2024, Lipocine and Verity Pharma entered into an exclusive License Agreement under which Verity Pharma will market TLANDO in the United States and, if approved, in Canada. The terms of the license agreement call for a license fee of $11 million and development and sales milestones of up to $259 million in aggregate, dependent on achievement of certain milestones. In addition, the Company is eligible to receive tiered royalty payments ranging from 12% up to 18% on net sales in the U.S. and Canada.
  • 2024年1月,Lipocine和Verity Pharma簽訂了獨家許可協議,根據該協議,Verity Pharma將在美國銷售TLANDO,如果獲得批准,還將在加拿大銷售。許可協議的條款要求支付1100萬美元的許可費,開發和銷售里程碑總額高達2.59億美元,具體取決於某些里程碑的實現情況。此外,公司有資格獲得分級特許權使用費,金額從美國和加拿大淨銷售額的12%到18%不等。

First Quarter Ended March 31, 2024 Financial Results

截至2024年3月31日的第一季度財務業績

Lipocine reported net income of $3.5 million, or $0.66 per diluted share, for the first quarter ended March 31, 2024, compared with a net loss of $3.9 million, or ($0.76) per diluted share, for the quarter ended March 31, 2023.

Lipocine報告稱,截至2024年3月31日的第一季度淨收益爲350萬美元,攤薄每股收益爲0.66美元,而截至2023年3月31日的季度淨虧損爲390萬美元,攤薄每股虧損0.76美元。

Revenue in the first quarter of 2024 was $7.6 million, primarily consisting of licensing revenue received from the Verity License Agreement. This compares with revenue of $0.06 million in the comparable period in 2023.

2024年第一季度的收入爲760萬美元,主要包括從Verity許可協議中獲得的許可收入。相比之下,2023年同期的收入爲06萬美元。

Research and development expenses were $2.8 million and $3.1 million, respectively, for the quarters ended March 31, 2024 and 2023. The decrease in research and development expenses was a result of a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1148 study late in 2023, a decrease in personnel related costs, and a decrease in LPCN 1111 costs, offset by an increase in costs related to our LPCN 1154 clinical studies, and an increase in other R&D related costs.

截至2024年3月31日和2023年3月31日的季度,研發費用分別爲280萬美元和310萬美元。研發費用的減少是由於與2023年底完成LPCN 1148研究相關的合同研究組織費用和外部諮詢成本的減少、人員相關成本的減少以及LPCN 1111成本的減少,但與我們的LPCN 1154臨床研究相關的成本增加以及其他研發相關成本的增加所抵消。

General and administrative expenses were $1.6 million and $1.3 million, respectively for the quarters ended March 31, 2024 and 2023. The increase in general and administrative expenses was a result of an increase in business development expenses and in other various general and administrative expenses. These increases were offset by a decrease in various administrative consulting fees, a decrease in corporate insurance expense, a decrease in personnel salaries and benefits, and a decrease in legal fees.

截至2024年3月31日和2023年3月31日的季度,一般和管理費用分別爲160萬美元和130萬美元。一般和管理費用的增加是業務發展支出和其他各種一般和管理費用增加的結果。這些增長被各種行政諮詢費的減少、公司保險費用的減少、人員工資和福利的減少以及律師費的減少所抵消。

As of March 31, 2024, Lipocine had $24.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023.

截至2024年3月31日,Lipocine擁有2,460萬美元的非限制性現金、現金等價物和有價投資證券,而截至2023年12月31日爲2,200萬美元。

About Lipocine

關於 Liocine

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. 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是一家生物製藥公司,利用其專有技術平台,通過有效的口服給藥來增強治療效果,開發針對中樞神經系統疾病的差異化產品。Lipocine有候選藥物正在開發中,還有我們正在探索合作夥伴關係的候選藥物。我們的候選藥物代表了差異化的、對患者友好的口服給藥選擇的支持,這些方案針對的是醫療需求未得到滿足的大型潛在市場,從而爲風險狀況帶來了有利的益處。

Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis including prevention of the recurrence of overt hepatic encephalopathy. Lipocine is exploring partnership opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, LPCN 2401 for obesity management and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. 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.

Lipocine的臨床開發候選藥物包括:LPCN 1154,口服佈雷沙諾酮,用於潛在的產後抑鬱症治療,LPCN 2101,用於治療特發性震顫的口服候選藥物,LPCN 2401,一種合成代謝雄激素受體激動劑和α-生育酚(一種抗氧化劑)作爲輔助劑的口服專有組合治療腸促胰島素模擬劑作爲改善慢性體重管理中的身體成分的輔助手段和LPCN 1148,一種用於口服給藥的新型雄激素受體激動劑前藥旨在治療與肝硬化相關的症狀,包括預防明顯的肝性腦病復發。Lipocine正在爲LPCN 1107、我們的早產預防候選藥LPCN 1154、用於快速緩解產後抑鬱症的LPCN 1148、用於管理失代償性肝硬化的LPCN 2401、用於肥胖管理的LPCN 2401和我們的非肝硬化NASH治療候選藥物LPCN 1144探索合作機會。TLANDO是由Lipocine開發的一種含有十一酸****激素的新型口服前藥,已獲得美國食品藥品管理局的批准,用於與成年男性內源性****激素缺乏相關的疾病,也稱爲性腺機能減退。欲了解更多信息,請訪問 www.lipocine.com

Forward-Looking Statements

前瞻性陳述

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 product development efforts, our strategic plans for developing products to treat CNS disorders, our ability to monetize product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates. 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 to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will 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.

本新聞稿包含根據1995年《私人證券訴訟改革法》的安全港條款作出的 “前瞻性陳述”,其中包括有關我們的產品開發工作、我們開發治療中樞神經系統疾病產品的戰略計劃、我們通過候選產品獲利的能力(包括簽訂合作安排)、應用我們的專有平台開發中樞神經系統疾病新療法、我們的候選產品和相關臨床試驗的歷史事實的陳述,臨床試驗中里程碑的實現和完成情況、監管審查的時間和完成情況、候選產品的臨床試驗結果以及候選產品的潛在用途和益處。投資者請注意,所有這些前瞻性陳述都涉及風險和不確定性,包括但不限於我們可能無法成功開發治療中樞神經系統疾病的候選產品的風險,我們可能沒有足夠的資金來完成候選產品的開發流程,我們可能無法建立合作伙伴關係或其他戰略關係來通過我們的非核心資產獲利,美國食品和藥物管理局不會批准我們的任何產品,與我們的產品相關的風險,預期的產品收益不是正在實現,臨床以及監管預期和計劃尚未實現、新的監管發展和要求、與美國食品藥品管理局批准程序相關的風險,包括獲得監管部門的批准,以及我們利用簡化的LPCN 1154批准途徑的能力、臨床試驗的結果和時間、患者對Lipocine產品的接受程度、Lipocine產品的製造和商業化以及Lipocine向美國證券交易委員會提交的文件中詳述的其他風險,包括但不限於其 10-K 表和其他關於 8-K 和 10-Q 表格的報告,全部是可以在美國證券交易委員會的網站www.sec.gov上獲得。除非法律要求,否則Lipocine沒有義務公開更新或修改本新聞稿中包含的任何前瞻性陳述。

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets








March 31,


December 31,



2024


2023

Assets





Current assets:






Cash and cash equivalents


$ 3,081,337


$ 4,771,758


Marketable investment securities


21,550,661


17,263,788


Accrued interest income


100,134


52,254


Prepaid and other current assets


583,087


773,424



Total current assets


25,315,219


22,861,224








Property and equipment, net of accumulated depreciation of $1,190,703 and $1,182,191 respectively


107,583


116,095

Other assets


23,753


23,753



Total assets


$ 25,446,555


$ 23,001,072













Liabilities and Stockholders' Equity





Current liabilities:






Accounts payable


$ 671,445


$ 1,395,977


Accrued expenses


761,465


1,218,486


Warrant liability - current portion


57,238


17,166



Total current liabilities


1,490,148


2,631,629










Total liabilities


1,490,148


2,631,629







Stockholders' equity:






Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,316,166 issued and

5,315,830 outstanding


8,860


8,860


Additional paid-in capital


220,262,456


220,171,250


Treasury stock at cost, 336 shares


(40,712)


(40,712)


Accumulated other comprehensive gain (loss)


(10,604)


7,259


Accumulated deficit


(196,263,593)


(199,777,214)



Total stockholders' equity


23,956,407


20,369,443









Total liabilities and stockholders' equity


$ 25,446,555


$ 23,001,072

LOPICINE INC和子公司

簡明合併資產負債表








3月31日


十二月三十一日



2024


2023

資產





流動資產:






現金和現金等價物


3,081,337 美元


4,771,758 美元


有價投資證券


21,550,661


17,263,788


應計利息收入


100,134


52,254


預付資產和其他流動資產


583,087


773,424



流動資產總額


25,315,219


22,861,224








財產和設備,分別扣除1,190,703美元和1,182,191美元的累計折舊


107,583


116,095

其他資產


23,753


23,753



總資產


25,446,555 美元


23,001,072 美元













負債和股東權益





流動負債:






應付賬款


671,445 美元


1,395,977 美元


應計費用


761,465


1,218,486


認股權證負債——流動部分


57,238


17,166



流動負債總額


1,490,148


2,631,629










負債總額


1,490,148


2,631,629







股東權益:






普通股,面值每股0.0001美元,已授權2億股;已發行5,316,166股和

5,315,830 未繳款項


8,860


8,860


額外的實收資本


220,262,456


220,171,250


按成本計算的庫存股,336 股


(40,712)


(40,712)


累計其他綜合收益(虧損)


(10,604)


7,259


累計赤字


(196,263,593)


(199,777,214)



股東權益總額


23,956,407


20,369,443









負債和股東權益總額


25,446,555 美元


23,001,072 美元

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)














Three Months Ended March 31,







2024


2023












Revenues:








License revenue


$ 7,500,000


$ 54,990




Royalty revenue


117,174


-





Total revenues


7,617,174


54,990












Operating expenses:








Research and development


2,818,926


3,106,310




General and administrative


1,575,719


1,287,313





Total operating expenses


4,394,645


4,393,623














Operating income (loss)


3,222,529


(4,338,633)












Other income (expense):








Interest and investment income


331,364


370,469




Unrealized gain (loss) on warrant liability


(40,072)


98,134





Total other income, net


291,292


468,603














Income (loss) before income tax expense


3,513,821


(3,870,030)












Income tax expense


(200)


(200)





Net income (loss)


3,513,621


(3,870,230)





Issuance of Series B preferred stock dividend


-


(89)





Net income (loss) attributable to common shareholders


$ 3,513,621


$ (3,870,319)












Basic income (loss) per share attributable to common stock


$ 0.66


$ (0.74)



Weighted average common shares outstanding, basic


5,315,830


5,234,830












Diluted income (loss) per share attributable to common stock


$ 0.66


$ (0.76)



Weighted average common shares outstanding, diluted


5,357,530


5,234,830












Comprehensive loss:









Net income (loss)


$ 3,513,621


$ (3,870,319)





Net unrealized gain (loss) on available-for-sale securities


(17,863)


23,562














Comprehensive income (loss)


$ 3,495,758


$ (3,846,757)



LOPICINE INC和子公司

簡明合併運營報表和綜合收益(虧損)














截至3月31日的三個月







2024


2023












收入:








許可證收入


7,500,000 美元


54,990 美元




特許權使用費收入


117,174


-





總收入


7,617,174


54,990












運營費用:








研究和開發


2,818,926


3,106,310




一般和行政


1,575,719


1,287,313





運營費用總額


4,394,645


4,393,623














營業收入(虧損)


3,222,529


(4,338,633)












其他收入(支出):








利息和投資收益


331,364


370,469




認股權證負債的未實現收益(虧損)


(40,072)


98,134





其他收入總額,淨額


291,292


468,603














所得稅支出前的收入(虧損)


3,513,821


(3,870,030)












所得稅支出


(200)


(200)





淨收益(虧損)


3,513,621


(3,870,230)





發行B系列優先股股息


-


(89)





歸屬於普通股股東的淨收益(虧損)


3,513,621 美元


$ (3,870,319)












歸屬於普通股的每股基本收益(虧損)


0.66 美元


美元 (0.74)



已發行普通股的加權平均值,基本


5,315,830


5,234,830












歸屬於普通股的每股攤薄收益(虧損)


0.66 美元


美元 (0.76)



已發行普通股的加權平均值,攤薄


5,357,530


5,234,830












綜合損失:









淨收益(虧損)


3,513,621 美元


$ (3,870,319)





可供出售證券的未實現淨收益(虧損)


(17,863)


23,562














綜合收益(虧損)


3,495,758 美元


$ (3,846,757)



SOURCE Lipocine Inc.

來源 Lipocine Inc.

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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