Cellectar Biosciences(CLRB) - 2024 Q1 - Quarterly Results

Q1 2024 Earnings Release Overview Cellectar Biosciences announced its Q1 2024 financial results and provided updates on its clinical programs, including positive data from the CLOVER WaM study Announcement and Key Updates Cellectar Biosciences announced its financial results for the first quarter ended March 31, 2024, along with a corporate update, highlighting progress in its clinical programs and financial position - Cellectar Biosciences (NASDAQ: CLRB) is a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer[2] - The company plans to announce data from its CLOVER WaM pivotal study in Waldenstrom's macroglobulinemia in June and is on track to submit its NDA in the second half of 2024[15] - Positive topline data from the CLOVER WaM pivotal study achieved its primary endpoint with a major response rate of 61% and an overall response rate of 75.6% in relapsed/refractory Waldenstrom's macroglobulinemia patients[15] Corporate and Clinical Highlights The company reported significant clinical trial advancements and expanded its pipeline through strategic partnerships and novel therapeutic development Clinical Trial Progress The company reported significant advancements in its clinical pipeline, including positive data from the CLOVER WaM pivotal study for Waldenstrom's macroglobulinemia, progress in head and neck cancer and pediatric high-grade gliomas studies - Investigator-initiated Phase I study of iopofosine in combination with External Beam Radiotherapy in recurrent head and neck cancer reported a complete remission rate of 64% and overall response rate of 73% in highly refractory patients[3] - Durability of clinical activity in head and neck cancer achieved a 67% overall survival and 42% progression-free survival at one year[3] - The first patient was enrolled in the Phase 1b clinical study of iopofosine I 131 in pediatric high-grade gliomas (pHGG), supported by a $2 million Fast Track SBIR grant from the NCI[4] - Reported complete central nervous system clearance in a relapsed/refractory Waldenstrom's macroglobulinemia patient, validating iopofosine I 131 for tumors across the blood-brain barrier[16] Strategic Partnerships & Pipeline Expansion Cellectar Biosciences announced strategic collaborations to advance WM treatment and expanded its pipeline with promising preclinical data for a novel alpha-emitting phospholipid radiotherapeutic conjugate - Strategic partnerships were announced with Florida Cancer Specialists and American Oncology Network (AON) to advance the treatment of WM in the community setting[5] - Promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225, was announced in pancreatic cancer models, expanding the company's clinical pipeline to include targeted alpha therapies (TATs)[17] - CLR 121225 is planned to enter a Phase 1 study in either triple negative breast or pancreatic cancer no later than the first quarter of 2025[15] First Quarter 2024 Financial Performance Cellectar Biosciences reported its Q1 2024 financial results, highlighting increased cash, higher R&D and G&A expenses, and a larger net loss Key Financial Highlights Cellectar Biosciences reported its financial results for Q1 2024, showing a significant increase in cash and cash equivalents, alongside increased R&D and G&A expenses, leading to a higher net loss compared to the prior year period Q1 2024 Financial Highlights | Metric | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | | :------------------------------------------- | :------------------------------------ | :------------------------------------ | | Cash and Cash Equivalents | $40.0 million | $9.6 million (as of Dec 31, 2023) | | Net cash used in operating activities | ~$13 million | N/A | | Research and Development Expense | $7.4 million | $6.7 million | | General and Administrative Expense | $4.6 million | $2.1 million | | Net Loss attributable to common stockholders | ($21.6) million | ($8.6) million | | Basic and Diluted Net Loss Per Share | ($0.74) | ($0.76) | - The company believes its cash balance of $40.0 million as of March 31, 2024, is adequate to fund its basic budgeted operations into the fourth quarter of 2024[6] - The increase in R&D expense was primarily due to increased manufacturing and related costs for supply chain and production sourcing enhancements, partially offset by a decrease in general R&D costs[18] - The increase in G&A costs was primarily driven by expenses associated with developing infrastructure for commercialization upon anticipated NDA approval, including marketing and personnel costs[7] About Cellectar Biosciences This section provides an overview of Cellectar Biosciences, a late-stage clinical biopharmaceutical company focused on developing targeted cancer treatments Company Overview and Mission Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing targeted cancer treatments using its proprietary Phospholipid Drug Conjugate (PDC) delivery platform - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, both independently and through collaborations[21] - The company's core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop next-generation cancer cell-targeting treatments, aiming for improved efficacy and better safety due to fewer off-target effects[21] - The product pipeline includes lead asset iopofosine I 131, proprietary preclinical PDC chemotherapeutic programs, and multiple partnered PDC assets[9] Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated balance sheets and statements of operations for the specified periods Condensed Consolidated Balance Sheets The unaudited condensed consolidated balance sheets provide a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity as of March 31, 2024, and December 31, 2023 Condensed Consolidated Balance Sheets (Unaudited) | ASSETS | March 31, 2024 ($) | December 31, 2023 ($) | | :---------------------------------------- | :----------------- | :-------------------- | | Cash and cash equivalents | $40,031,181 | $9,564,988 | | Prepaid expenses and other current assets | $1,337,184 | $888,225 | | Total current assets | $41,368,365 | $10,453,213 | | Fixed assets, net | $1,023,447 | $1,090,304 | | Right-of-use asset, net | $486,847 | $502,283 | | Long-term assets | $23,566 | $23,566 | | Other assets | $6,214 | $6,214 | | TOTAL ASSETS | $42,908,439 | $12,075,580 | | LIABILITIES AND STOCKHOLDERS' EQUITY | March 31, 2024 ($) | December 31, 2023 ($) | | :---------------------------------------- | :----------------- | :-------------------- | | Accounts payable and accrued liabilities | $7,393,950 | $9,178,645 | | Warrant liability | $8,800,000 | $3,700,000 | | Lease liability | $73,994 | $58,979 | | Total current liabilities | $16,267,944 | $12,937,624 | | Long-term lease liability, net of current portion | $474,349 | $494,003 | | TOTAL LIABILITIES | $16,742,293 | $13,431,627 | | Total Stockholders' Equity | $26,166,146 | ($1,356,047) | Condensed Consolidated Statements of Operations The unaudited condensed consolidated statements of operations detail the company's revenues, expenses, and net loss for the three months ended March 31, 2024, compared to the same period in 2023 Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2024 ($) | Three Months Ended March 31, 2023 ($) | | :------------------------------------------------------------------ | :------------------------------------ | :------------------------------------ | | Research and development | $7,377,940 | $6,654,094 | | General and administrative | $4,623,546 | $2,051,207 | | Total costs and expenses | $12,001,486 | $8,705,301 | | LOSS FROM OPERATIONS | ($12,001,486) | ($8,705,301) | | Loss on valuation of warrants | ($9,900,000) | — | | Interest income, net | $319,849 | $124,034 | | NET LOSS | ($21,581,637) | ($8,581,267) | | BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | ($0.74) | ($0.76) | | SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS | 29,346,679 | 11,261,217 | Additional Information This section provides details on the Q1 2024 conference call, forward-looking statement disclaimers, and contact information Conference Call & Webcast Details This section provides information regarding the investor conference call held on May 14, 2024, to discuss the Q1 2024 financial results and corporate updates - Management hosted a conference call on May 14, 2024, at 8:30 am ET to discuss financial results and provide a corporate update[2][20] - The call was available via webcast on the company's website[20] Forward-Looking Statements This section contains a disclaimer regarding forward-looking statements, emphasizing that such statements are estimates and predictions subject to various known and unknown risks and uncertainties - The news release contains forward-looking statements, identifiable by words such as 'may,' 'expect,' 'believe,' 'anticipate,' 'intend,' 'could,' 'estimate,' 'continue,' and 'plans'[23] - These statements are estimates and predictions subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially[23] - Factors that might cause material differences include uncertainties related to capital raising, supply chain disruptions, partnerships, clinical study completion, FDA review, government regulation, competition, and product pricing[23] Contacts Contact information for investor relations and media inquiries is provided for interested parties - For investor inquiries, contact Chad Kolean, Chief Financial Officer, at investors@cellectar.com[11] - For media inquiries, contact Claire LaCagnina of Bliss Bio Health at 315-765-1462 or clacagnina@blissbiohealth.com[24]