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Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update

Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update

cellectar biosciences 發佈2024年第三季度財務業績並提供公司更新
GlobeNewswire ·  11/18 20:05

Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66th Annual American Society of Hematology Meeting and Exposition

第二階段CLOVER-Wam關鍵研究數據被選爲在第66屆美國血液學會年會和博覽會上的口頭報告

Raised approximately $19.4 million with potential to raise up to an additional $73.3 million

籌集了大約1940萬美元,有潛力再籌集7330萬美元

Company to hold webcast and conference call at 8:30 AM ET today

公司將在今天東部時間上午8:30舉行網絡廣播和電話會議

FLORHAM PARK, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the quarter ended September 30, 2024, and provided a corporate update.

新澤西州佛羅哈姆公園,2024年11月18日(全球新聞社) -- Cellectar biosciences公司(納斯達克:CLRB),一家專注於癌症治療藥物的發現、開發和商業化的晚期臨床生物製藥公司,今天公佈了截至2024年9月30日的季度財務結果,並提供了公司更新信息。

"We achieved important clinical, operational and commercial corporate objectives during the quarter. We reported topline results from the CLOVER-WaM pivotal study in WM and look forward to filing our NDA submission with a request for accelerated regulatory approval in the coming months," said James Caruso, president and CEO of Cellectar Biosciences. "In addition to our lead iopofosine I 131 program, we plan to further advance the value of our phospholipid radioconjugate pipeline and are preparing alpha and Auger PRCs for initiation of solid tumor clinical studies as business conditions allow."

"我們在本季度達成了重要的臨床、運營和商業公司目標。我們報告了CLOVER-Wam關鍵研究的頂線結果,並期待在接下來的幾個月內提交我們的NDA申請,以請求加速監管審批,"Cellectar Biosciences的總裁兼首席執行官James Caruso說。"除了我們主要的iopofosine I 131項目外,我們計劃進一步提升我們磷脂輻射結合管線的價值,並準備啓動實體腫瘤臨床研究的alpha和Auger PRCs,以便在商業條件允許的情況下進行。"

Third Quarter and Recent Corporate Highlights

第三季度和近期公司亮點

  • Reported positive results from the Phase 2 CLOVER-WaM pivotal study evaluating iopofosine I 131, the company's potentially first-in-class, targeted radiotherapeutic candidate, for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia (WM). These results support the company's planned filing of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the near term.
  • Selected to present data from the CLOVER-WaM study evaluating iopofosine I 131 in patients with WM at the upcoming 66th Annual American Society of Hematology Meeting and Exposition (ASH), in an oral presentation session. Details of the oral presentation are as follows:
    • Abstract Title: Iopofosine I 131 in Previously Treated Patients with Waldenström Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM)
    • Session Name: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Clinical Trials for Marginal Zone Lymphoma, Waldenstrom's Macroglobulinemia and Hairy Cell Leukemia
    • Session Date: Monday, December 9, 2024
    • Presentation Time: 3:15 PM PST
  • Delivered oral and poster presentations at the 12th International Workshop on Waldenstrom's Macroglobulinemia (IWWM) in October 2024 that highlighted the activity of iopofosine I 131 in WM.
    • Oral presentation: Session XXII Clinical Trials in Progress for WM: Multi-center trial of iopofosine I-131 in relapsed/refractory WM
    • Poster presentation: Treatment With iopofosine I 131 in a Patient With Bing-Neel Syndrome, A Rare Manifestation of Waldenström Macroglobulinemia: A Case Report
  • Advanced sales, marketing and medical planning activities to support iopofosine I 131 commercialization
  • Partnered with key national and regional community cancer networks to better understand the WM disease landscape, to advance iopofosine I 131 for WM patients in the community setting
  • Established collaboration with the City of Hope Cancer Center to evaluate iopofosine I 131 in mycosis fungoides, a cutaneous T-cell lymphoma
  • Executed supply and manufacturing agreements, further strengthening our multi-sourced supply network:
    • Commercial finished product supply of iopofosine I 131 with SpectronRx
    • Pre-clinical and clinical supply of alpha-emitting actinium 225 isotope with Northstar Medical Radioisotopes
  • Raised $19.4 million through warrant exercises and issued new milestone-based warrants with the potential to raise up to an additional $73.3 million. Funds generated from the execution of these new warrants will further advance the company's commercialization plans for iopofosine I 131 in the treatment of WM and support future clinical development.
  • 報告了關於iopofosine I 131的第二階段CLOVER-Wam關鍵研究的積極結果,該候選藥物是公司潛在的首個靶向放射治療候選者,用於治療復發/難治性Waldenstrom的巨球蛋白血癥(WM)。這些結果支持公司計劃在近期向美國食品藥品監督管理局(FDA)提交新藥申請(NDA)。
  • 被選中在即將召開的第66屆美國血液學會年會及博覽會(ASH)上口頭報告CLOVER-Wam研究中評估iopofosine I 131對WM患者的數據顯示。口頭報告的詳細信息如下:
    • 摘要標題: iopofosine I 131在曾接受治療的Waldenström巨球蛋白血癥(WM)患者中的應用:國際多中心開放標籤第二階段研究(CLOVER-WaM)的療效和安全性結果
    • 會議名稱: 623. 殼細胞、濾泡細胞、沃爾登斯特羅姆病及其他惰性B細胞淋巴瘤:臨床和流行病學:邊緣區淋巴瘤、沃爾登斯特羅姆巨球蛋白血癥及毛細胞白血病的臨床試驗
    • 會議日期: 2024年12月9日,星期一
    • 演講時間: 太平洋標準時間下午3:15
  • 在2024年10月舉行的第十二屆沃爾登斯特羅姆巨球蛋白血癥國際研討會上進行了口頭和海報報告,突出了iopofosine I 131在沃爾登斯特羅姆疾病中的活性。
    • 口頭報告:第XXII節 沃爾登斯特羅姆病正在進行的臨床試驗:iopofosine I-131在復發/難治性沃爾登斯特羅姆病中的多中心試驗
    • 海報展示:使用iopofosine I 131治療Bing-Neel綜合症,這是一種Waldenström巨球蛋白血癥的罕見表現:病例報告
  • 支持iopofosine I 131商業化的高級銷售、市場和醫療規劃活動
  • 與關鍵的國家和區域型社區癌症網絡合作,以更好地了解Wm疾病的全景圖,推動iopofosine I 131在社區環境中爲Wm患者提供支持
  • 與希望之城癌症中心建立合作,評估iopofosine I 131在真菌性肉芽腫(皮膚T細胞淋巴瘤)中的應用
  • 執行供應和製造協議,進一步加強我們的多元化供應網絡:
    • iopofosine I 131商業成品的供應與SpectronRx
    • 與Northstar Medical Radioisotopes合作,提供放射性鈾-225同位素的臨床前和臨床供給
  • 通過warrants行使籌集了1940萬美元,併發行了新的基於里程碑的warrants,可能額外籌集高達7330萬美元。這些新warrants的執行生成的資金將進一步推動公司在Wm治療中iopofosine I 131的商業化計劃,並支持未來的臨床開發。

Third Quarter 2024 Financial Highlights

2024年第三季度財務亮點

  • Cash and Cash Equivalents: As of September 30, 2024, the company had cash and cash equivalents of $34.3 million, including 19.4 million ($17.5 million, net) raised through investor exercises of Tranche B warrants and the purchase of new warrants in July 2024, compared to $9.6 million as of December 31, 2023. The company believes its cash balance as of September 30, 2024, is adequate to fund its basic budgeted operations into the second quarter of 2025.
  • Research and Development Expenses: R&D expenses for the three months ended September 30, 2024, were approximately $5.5 million, compared to approximately $7.0 million for the three months ended September 30, 2023. The overall decrease was primarily a result of the conclusion of patient enrollment in our WM pivotal study having occurred earlier in the year, partially offset by increased activity in our ongoing pediatric trial and an increase in personnel.
  • General and Administrative Expenses: G&A expenses for the three months ended September 30, 2024, were approximately $7.8 million, compared to approximately $2.4 million for the same period in 2023. The increase was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel cost.
  • 現金及現金等價物:截至2024年9月30日,公司擁有現金及現金等價物3430萬美元,包括通過投資者行使Tranche b warrants和2024年7月購買新warrants籌集的1940萬美元(1750萬美元,淨額),而截至2023年12月31日爲960萬美元。公司認爲,截至2024年9月30日的現金餘額足以支持其基本預算運作到2025年第二季度。
  • 研發費用:截至2024年9月30日的三個月研發費用約爲550萬美元,而截至2023年9月30日的三個月研發費用約爲700萬美元。整體下降主要是由於我們Wm關鍵研究的患者入組在年初就結束了,部分被我們正在進行的兒童試驗的活動增加和人員的增加抵消。
  • 一般和管理費用:截至2024年9月30日的三個月G&A費用約爲780萬美元,而2023年同期約爲240萬美元。增加主要是由於與開發支持商業化所需的基礎設施相關的費用,包括相關的營銷和人員成本。

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, November 18, 2024, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar's website at . A recording of the webcast will be available and archived on the Company's website for approximately 90 days.

電話會議和網絡研討會詳情
cellectar biosciences管理層將於2024年11月18日東部時間上午8:30舉辦一場電話會議和網絡直播,討論這些結果並回答問題。股東和其他感興趣的方可以撥打1-800-717-1738參與電話會議。電話會議的現場直播可以在cellectar biosciences網站的「活動與演示」部分訪問。會議錄音將在公司網站上保存約90天。

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company's core objective is to leverage its proprietary Phospholipid Drug Conjugate (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.

關於Cellectar Biosciences,Inc。
cellectar biosciences是一家處於後期臨床階段的生物製藥公司,專注於癌症治療的專有藥物的發現、開發和商業化,獨立進行以及通過研究和開發合作。公司的核心目標是利用其專有的磷脂藥物結合物(PDC)遞送平台開發下一代針對癌細胞的治療,提供更高的療效和更好的安全性,從而減少偏離靶點的副作用。

The company's product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

公司的產品管線包括主要資產Iopofosine I 131,這是一種小分子PDC,旨在爲碘-131(放射性同位素)提供靶向輸送,專有的臨床前PDC化學療法項目和多種合作PDC資產。

For more information, please visit or join the conversation by liking and following us on the company's social media channels: X, LinkedIn, and Facebook.

有關更多信息,請訪問或通過在公司的社交媒體渠道上點贊和關注我們來加入討論:X,LinkedIn和Facebook。

Forward Looking Statements Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations regarding the CLOVER-WaM pivotal trial. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

前瞻性聲明免責聲明
本新聞稿包含前瞻性聲明。你可以通過我們使用的諸如「可能」、「期望」、「相信」、「預期」、「打算」、「可以」、「估計」、「繼續」、「計劃」或其否定形式和同源詞等詞彙來識別這些聲明。這些聲明僅僅是估計和預測,並且受到已知和未知風險與不確定性的影響,這些不確定性可能導致實際的未來經驗和結果與所作聲明存在重大差異。這些聲明基於我們對未來結果的當前信念和期望,包括我們對CLOVER-Wam關鍵試驗的期望。藥物發現和開發涉及高度的風險。可能導致重大差異的因素包括,但不限於,籌集額外資本的能力的不確定性,iopofosine唯一供應商的干擾的不確定性,吸引和留住技術合作夥伴的能力,領先化合物的識別,成功的臨床前開發,患者招募和臨床研究的完成,FDA審查過程和其他政府監管,保持iopofosine在美國的孤兒藥資格的能力,優先審查券的波動市場,我們藥品合作伙伴成功開發和商業化藥物候選人能力,來自其他製藥公司的競爭,產品定價和第三方報銷。關於我們業務相關的風險和不確定性的完整描述包含在我們向證券交易委員會提交的定期報告中,包括截至2023年12月31日的10-K/A表格和截至2024年9月30日的10-Q表格。這些前瞻性聲明僅在本日期作出,我們不承擔更新任何此類前瞻性聲明的義務。

MEDIA:
Claire LaCagnina
Bliss Bio Health
315-765-1462
clacagnina@blissbiohealth.com

媒體:
Claire LaCagnina
Bliss Bio Health
315-765-1462
clacagnina@blissbiohealth.com

INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com

投資者:
Anne Marie Fields
Josh.Rappaport@precisionaq.com
212-362-1200
annemarie.fields@precisionaq.com

+++ TABLES TO FOLLOW +++

+++ 表格即將跟進 +++

CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2024 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 34,263,371 $ 9,564,988
Prepaid expenses and other current assets 1,635,818 888,225
Total current assets 35,899,189 10,453,213
Property, plant & equipment, net 910,131 1,090,304
Operating lease right-of-use asset 454,166 502,283
Other long-term assets 29,780 29,780
TOTAL ASSETS $ 37,293,266 $ 12,075,580
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable and accrued liabilities $ 8,304,311 $ 9,178,645
Warrant liability 11,929,242 16,120,898
Lease liability, current 80,821 58,979
Total current liabilities 20,314,374 25,358,522
Long-term lease liability, net of current portion 431,929 494,003
TOTAL LIABILITIES 20,746,303 25,852,525
COMMITMENTS AND CONTINGENCIES
MEZZANINE EQUITY:
Series D preferred stock, 111.11 shares authorized, issued and outstanding as of September 30, 2024 and December 31, 2023 1,382,023 1,382,023
STOCKHOLDERS' EQUITY (DEFICIT):
Series E-2 preferred stock, 1,225.00 shares authorized; 149.60 and 319.76 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 2,188,434 4,677,632
Series E-3 preferred stock, 2,205.00 shares authorized; 202.50 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 4,369,317
Series E-4 preferred stock, 1,610.00 shares authorized; 714.00 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 7,057,793
Common stock, $0.00001 par value; 170,000,000 shares authorized; 40,566,534 and 20,744,110 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 406 207
Additional paid-in capital 246,536,080 182,924,210
Accumulated deficit (244,987,090) (202,761,017)
Total stockholders' equity (deficit) 15,164,940 (15,158,968)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $ 37,293,266 $ 12,075,580
CELLECTAR BIOSCIENCES,INC.
簡明合併資產負債表
(未經審計)
九月三十日, 12月31日,
2024 2023
資產
流動資產:
現金及現金等價物 $ 34,263,371 $ 9,564,988
預付費用及其他流動資產 1,635,818 888,225
總流動資產 35,899,189 10,453,213
固定資產、廠房和設備,淨額 910,131 1,090,304
經營租賃資產使用權 454,166 502,283
其他長期資產 29,780 29,780
資產總計 $ 37,293,266 $ 12,075,580
負債和股東權益(赤字)
流動負債:
應付賬款及應計負債 $ 8,304,311 $ 9,178,645
認股權責任 11,929,242 16,120,898
租賃負債,流動 80,821 58,979
總流動負債 20,314,374 25,358,522
長期租賃負債,扣除應付本金 431,929 494,003
負債合計 20,746,303 25,852,525
承諾和 contingencies
中間資本:
D系列優先股,截至2024年9月30日和2023年12月31日,授權、發行和流通的股份數爲111.11股 1,382,023 1,382,023
股東權益(赤字):
系列E-2優先股,授權發行1,225.00股;截至2024年9月30日和2023年12月31日,已發行並流通149.60股和319.76股。 2,188,434 4,677,632
系列E-3優先股,授權發行2,205.00股;截至2024年9月30日和2023年12月31日,已發行並流通202.50股和0股。 4,369,317
E-4系列優先股,授權發行1,610.00股;截至2024年9月30日和2023年12月31日,分別已發行並流通714.00股和0股 7,057,793
普通股,面值$0.00001;授權股份170,000,000股;截至2024年9月30日和2023年12月31日,已發行和流通的股份分別爲40,566,534股和20,744,110股 406 207
追加實收資本 246,536,080 182,924,210
累積赤字 (244,987,090) (202,761,017)
股東權益合計(赤字) 15,164,940 (15,158,968)
總負債和股東權益(赤字) $ 37,293,266 $ 12,075,580
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2024 2023 2024 2023
OPERATING EXPENSES:
Research and development $ 5,493,496 $ 7,034,656 $ 19,927,019 $ 19,528,898
General and administrative 7,834,181 2,378,804 19,105,853 6,883,866
Total operating expenses 13,327,677 9,413,460 39,032,872 26,412,764
LOSS FROM OPERATIONS (13,327,677) (9,413,460) (39,032,872) (26,412,764)
OTHER INCOME (EXPENSE):
Warrant issuance expense (7,743,284) (470,000) (7,743,284) (470,000)
Gain (loss) on valuation of warrants 6,088,355 (7,688,028) 3,583,440 (8,254,649)
Interest income 317,887 51,110 966,643 247,925
Total other income (expense) (1,337,042) (8,106,918) (3,193,201) (8,476,724)
NET LOSS $ (14,664,719) $ (17,520,378) (42,226,073) $ (34,889,488)
NET LOSS PER SHARE — BASIC $ (0.37) $ (1.55) (1.21) $ (3.09)
NET LOSS PER SHARE — DILUTED $ (0.40) $ (1.55) (1.39) $ (3.09)
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC 39,335,924 11,308,738 34,850,441 11,277,231
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED 39,794,220 11,308,738 35,545,500 11,277,231
CELLECTAR BIOSCIENCES,INC.
簡明綜合經營表
(未經審計)
截至9月30日的三個月 截至9月30日的九個月
2024 2023 2024 2023
營業費用:
研發 $ 5,493,496 $ 7,034,656 $ 19,927,019 $ 19,528,898
一般和行政 7,834,181 2,378,804 19,105,853 6,883,866
總營業費用 13,327,677 9,413,460 39,032,872 26,412,764
營業虧損 (13,327,677) (9,413,460) (39,032,872) (26,412,764)
其他收益(費用):
(7,743,284) (470,000) (7,743,284) (470,000)
認股權證估值收益(損失) 6,088,355 (7,688,028) 3,583,440 (8,254,649)
利息收入 317,887 51,110 966,643 247,925
其他收入(支出)總額 (1,337,042) (8,106,918) (3,193,201) (8,476,724)
淨損失 $ (14,664,719) $ (17,520,378) (42,226,073) $ (34,889,488)
每股虧損 - 基本 $ (0.37) $ (1.55) 某些非公認會計原則措施不反映我們的稅務費用或支付所需的現金; $ (3.09)
每股稀釋淨損失 $ (0.40) $ (1.55) (1.39) $ (3.09)
基本加權平均普通股流通量 39,335,924 11,308,738 34,850,441 11,277,231
稀釋後加權平均每股優先股實際已發行數量 39,794,220 11,308,738 35,545,500 11,277,231

譯文內容由第三人軟體翻譯。


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