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Cellectar Biosciences(CLRB) - 2024 Q3 - Earnings Call Transcript
2024-11-18 15:59
Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash and cash equivalents of $34.3 million, a significant increase from $9.6 million as of December 31, 2023, due to funds raised from investor exercises of Tranche B warrants [21] - Net loss for the period was $14.7 million or $0.37 per basic share, compared to a net loss of $17.5 million or $1.55 per basic share during the same period in 2023, indicating a reduction in losses [26] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $5.5 million in Q3 2024 from approximately $7.0 million in Q3 2023, primarily due to reduced clinical study costs [24] - General and administrative expenses increased to $7.8 million in Q3 2024 from $2.4 million in Q3 2023, driven by costs associated with commercialization infrastructure development [25] Market Data and Key Metrics Changes - The U.S. market for Waldenstrom's macroglobulinemia (WM) includes approximately 26,000 patients, with 1,500 to 1,900 new diagnoses annually, and about 11,500 patients requiring treatment in the relapsed/refractory setting [44] - There are approximately 5,700 patients in the total addressable market for third-line or greater therapy, highlighting a significant unmet need for new FDA-approved treatments [45][47] Company Strategy and Development Direction - The company is focused on the NDA submission for iopofosine I 131 in WM, with a planned product launch in the second half of 2025, despite a delay in NDA submission to potentially Q2 2025 [10][14] - Expansion of iopofosine I 131 to other indolent lymphomas is viewed as a smart investment to increase overall revenue opportunities [15] - The company is also exploring collaborations for clinical development in other indications, such as mycosis fungoides, and has plans for ongoing development in pediatric high-grade gliomas [37][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of iopofosine I 131 to become a first-in-class treatment for relapsed/refractory WM patients, supported by strong clinical data [31][77] - The company remains engaged with the FDA regarding the regulatory pathway and is committed to expediting the NDA submission process [58] Other Important Information - The company has secured a second manufacturing source for iopofosine I 131, enhancing production capacity and supply redundancy [15] - A strategic master supply agreement has been signed with Northstar Medical Radioisotopes for the procurement of Actinium-225, ensuring a reliable source for future development [74] Q&A Session Summary Question: Concerns about FDA's interest in confirmatory studies - Management clarified that the FDA has indicated that a confirmatory study is not required to be ongoing prior to NDA submission [82][83] Question: Financial guidance regarding cash runway and warrant exercises - Management noted that an interim raise may be required before the first tranche of warrants is exercised, but the overall $73 million from warrant exercises should satisfy commercial launch needs [86][88]
Cellectar Biosciences(CLRB) - 2024 Q3 - Quarterly Results
2024-11-18 12:15
Exhibit 99.1 Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66 Annual American Society of Hematology Meeting and Exposition Raised approximately $19.4 million with potential to raise up to an additional $73.3 million Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., November 18, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a latestage ...
Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update
GlobeNewswire News Room· 2024-11-18 12:05
Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66th Annual American Society of Hematology Meeting and Exposition Raised approximately $19.4 million with potential to raise up to an additional $73.3 million Company to hold webcast and conference call at 8:30 AM ET today 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 ...
Cellectar Biosciences(CLRB) - 2024 Q3 - Quarterly Report
2024-11-18 11:46
Table of Contents U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [mark one] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 1-36598 CELLECTAR BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) ...
Cellectar Biosciences and NorthStar Medical Radioisotopes Announce Partnership for Supply of Actinium-225
GlobeNewswire News Room· 2024-11-14 13:05
NorthStar to provide Cellectar with non-carrier-added Ac-225 for its expanded portfolio of clinical programs FLORHAM PARK, N.J., Nov. 14, 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 the signing of a strategic supply agreement with NorthStar Medical Radioisotopes, LLC, for the procurement of NorthStar’s non-carrier added (n.c ...
Cellectar Biosciences and SpectronRx Partner to Manufacture Novel Phospholipid Radioconjugate for the Treatment of Cancer
GlobeNewswire News Room· 2024-11-12 13:05
INDIANAPOLIS and FLORHAM PARK, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- SpectronRx, a leading radiopharmaceutical contract developer and manufacturer, and 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, have signed a commercial supply agreement for the manufacture of Cellectar’s first-in-class cancer therapy, iopofosine I 131. "We continue strengthening our supply netw ...
Cellectar Biosciences to Report Third Quarter Financial Results and Host a Conference Call on Monday, November 18, 2024
GlobeNewswire News Room· 2024-11-11 21:05
FLORHAM PARK, N.J., Nov. 11, 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 that the company will report financial results for the three months ended September 30, 2024, and provide a corporate update on November 18, 2024, at 8:30 a.m. Eastern Time. Conference Call & Webcast Details:Date:Monday, November 18, 2024Time:8:30 am E ...
Cellectar Biosciences Announces Compliance Regarding Filing of Form 10-Q
GlobeNewswire News Room· 2024-11-01 21:00
FLORHAM PARK, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company, announced today it received a letter dated October 31, 2024, from Nasdaq, Inc. informing the Company that it had regained compliance with Nasdaq Listing Rule 5250(c)(1). The Company filed the following on October 29, 2024, with the Securities and Exchange Commission: (i) restated audited consolidated financial statements for the fiscal years ended December 31, 20 ...
Cellectar Biosciences(CLRB) - 2024 Q2 - Quarterly Report
2024-10-29 21:09
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.00001 CLRB NASDAQ Capital Market U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [mark one] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ ...
Cellectar Biosciences to Present at IWWM Featuring Iopofosine I 131
ZACKS· 2024-08-30 18:42
Cellectar Biosciences, Inc. (CLRB) announced two presentations. The first presentation is regarding the treatment of Bing-Neel Syndrome ("BNS") with iopofosine I 131 and the second is the review of the company's CLOVER WaM pivotal study of iopofosine I 131. The company will present these data at the 12thInternational Workshop on Waldenstrom's Macroglobulinemia (IWWM) on Oct. 17, 2024, in Prague, Czech Republic. About Cellectar Biosciences' Iopofosine I 131 Iopofosine I 131 is a potential first-in-class, nov ...