Topline Summary and Update Financial Overview As of their Q1 filing, CLRB held $41.4 million in current assets, made up mostly of $40.0 million in cash and equivalents. Their operating expenses, or cash burn, for the quarter reached $12.0 million. After recognizing an addition $9.9 million in losses due to valuation of their warrants, the net loss for the quarter was $21.6 million. Cellectar Biosciences, Inc. (NASDAQ:CLRB) is a radiopharmaceutical-focused developmental biotech training their sites on a firs ...

Iopofosine I 131: U.S. WM Shares By Line of Therapy No Established Standard of Care Across All Lines of Therapy8 | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Financial Data and Key Metrics Changes - The cash and cash equivalent balance as of March 31, 2024, was $40.0 million, compared to $9.6 million as of December 31, 2023, indicating a significant increase in liquidity [28] - The net loss attributable to common stockholders for Q1 2024 was $21.4 million or $0.74 per share, compared to $8.6 million or $0.76 per share in the same period last year [30] - General and administrative (G&A) expenses for Q1 2024 were $4.6 million, up from $2.1 million in the previous year, driven by preparations for a product launch in 2025 [29] Business Line Data and Key Metrics Changes - The company reported a high rate of complete remission in a Phase 1 study of iopofosine in combination with external beam radiotherapy for recurrent head and neck cancer, with a complete remission rate of 64% and overall response rate of 73% [27] - Iopofosine has been positioned to capture share in the existing relapsed refractory market, with approximately 4700 patients currently in the third line or greater setting, which could expand to 5700 patients [69] Market Data and Key Metrics Changes - The total U.S. Waldenstrom's macroglobulinemia (WM) market is approximately $2.1 billion, with the current relapse refractory market valued at $1 billion [4] - Claims data indicates that over 60% of therapies used in the WM market are not FDA approved, highlighting a significant unmet need [34] Company Strategy and Development Direction - The company announced a strategic partnership with the American Oncology Network to advance the treatment of WM and ensure patient access to iopofosine I 131 [12] - The focus is on establishing iopofosine as a market share leader in WM, with ongoing preparations for a potential commercial launch upon FDA approval [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data announcement for the fully enrolled study patient population in June, which is expected to provide insights into treatment durability [2][17] - The company is optimistic about the potential of iopofosine I 131 in pediatric high-grade gliomas and plans to provide updates on its Phase 1b study in the second half of 2024 [76] Other Important Information - The company has implemented a modular manufacturing strategy to enhance scalability and reduce costs, allowing for rapid increases in supply to meet market demands [5][51] - The company is evaluating pricing strategies based on market research and analogs, with expectations for premium pricing due to the high unmet need in the WM market [35][102] Q&A Session Summary Question: What is the FDA filing timeline and have any sales members been hired? - The company expects to submit its NDA in the second half of the year, anticipating a six-month review period [78] - A highly talented sales team is being assembled to drive awareness and adoption of iopofosine [79] Question: Can you provide more details on pricing? - The company is confident in its ability to set a premium price based on market research and the high value of the treatment [102] Question: What are the company's plans for ex-U.S. negotiations? - The company is engaged in discussions with various parties for regional partnerships while also considering broader global strategies [90]

Exhibit 99.1 Management to host a conference call today at 8:30 am ET FLORHAM PARK, N.J., May 14, 2024 – 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 March 31, 2024, and provided a corporate update. First Quarter and Recent Corporate Highlights · Reported a complete remission rate of 64% and overall response ...

Management to host a conference call today at 8:30 am ET WM pivotal study data to be announced in June FLORHAM PARK, N.J., May 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 financial results for the quarter ended March 31, 2024, and provided a corporate update. "We plan to announce data from our CLOVER WaM pivotal study e ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Q1 2024 financials reflect increased cash and assets from financing, a $21.6 million net loss, and going concern doubts without additional funding [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, cash and total assets significantly increased to $40.0 million and $42.9 million respectively, driven by financing activities, shifting to positive stockholders' equity Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $40,031,181 | $9,564,988 | | Total current assets | $41,368,365 | $10,453,213 | | TOTAL ASSETS | $42,908,439 | $12,075,580 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $16,267,944 | $12,937,624 | | TOTAL LIABILITIES | $16,742,293 | $13,431,627 | | Total stockholders' equity (deficit) | $26,166,146 | $(1,356,047) | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2024 net loss increased to $21.6 million, driven by higher operating expenses and a $9.9 million non-cash warrant revaluation loss, with basic and diluted net loss per share at $0.74 Condensed Consolidated Statements of Operations (Unaudited, Three Months Ended March 31) | Account | 2024 | 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) | — | | NET LOSS | $(21,581,637) | $(8,581,267) | | BASIC AND DILUTED NET LOSS PER SHARE | $(0.74) | $(0.76) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2024 saw $13.4 million cash used in operations, offset by $43.8 million from financing, resulting in a net cash increase of $30.5 million and a quarter-end balance of $40.0 million Condensed Consolidated Statements of Cash Flows (Unaudited, Three Months Ended March 31) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Cash used in operating activities | $(13,361,641) | $(7,183,670) | | Cash used in investing activities | $(21,633) | — | | Cash provided by financing activities | $43,849,467 | $3 | | NET INCREASE (DECREASE) IN CASH | $30,466,193 | $(7,183,667) | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's biopharmaceutical business, an accumulated deficit of $239.1 million, and substantial doubt about its going concern ability beyond Q4 2024 without additional funding - The company is a late-stage clinical biopharmaceutical company focused on its proprietary phospholipid drug conjugate (PDC™) delivery platform for cancer treatment[23](index=23&type=chunk) - As of March 31, 2024, the company had an accumulated deficit of approximately **$239.1 million** and expects to continue generating operating losses[24](index=24&type=chunk) - Management believes its cash balance is adequate to fund operations into the fourth quarter of 2024, but this raises "substantial doubt about the Company's ability to continue as a going concern" without obtaining additional funding[24](index=24&type=chunk)[25](index=25&type=chunk) - In January 2024, the company received net proceeds of **$42.8 million** from the exercise of Tranche A warrants, which were triggered by the release of positive topline data from the CLOVER WaM trial[51](index=51&type=chunk) - The fair value of outstanding warrant liabilities increased from **$3.7 million** at year-end 2023 to **$8.8 million** at March 31, 2024, resulting in a non-cash loss of **$9.9 million** for the quarter[60](index=60&type=chunk)[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's late-stage biopharmaceutical focus, positive CLOVER-WaM study results, increased R&D and G&A expenses, and the need for additional capital beyond Q4 2024 [Overview and Clinical Pipeline](index=19&type=section&id=Overview%20and%20Clinical%20Pipeline) The company's lead drug, iopofosine I 131, showed positive pivotal CLOVER-WaM study results with a 61% MRR, exceeding the 20% hurdle, and holds multiple FDA and European designations for various cancers - The CLOVER-WaM pivotal study in r/r Waldenstrom's macroglobulinemia met its primary endpoint with a major response rate (MRR) of **61%**, surpassing the FDA-agreed statistical hurdle of **20%**[88](index=88&type=chunk) - In the CLOVER-WaM study, the overall response rate (ORR) was **75.6%**, and **100%** of patients experienced disease control. Responses were durable, with median duration of response not yet reached[88](index=88&type=chunk) - Iopofosine has received multiple regulatory designations, including FDA Fast Track for WM and MM, and Orphan Drug Designation for WM, MM, and several pediatric sarcomas[91](index=91&type=chunk) - A Phase 1 investigator-initiated study combining iopofosine with external beam radiation in recurrent head and neck cancer showed a **64%** complete remission rate and a **73%** ORR[127](index=127&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Q1 2024 R&D expenses increased by 11% to $7.4 million due to manufacturing costs, while G&A expenses surged 125% to $4.6 million for commercialization infrastructure Research and Development Costs Comparison (Three Months Ended March 31) | Category | 2024 | 2023 | Variance | | :--- | :--- | :--- | :--- | | Clinical project costs | $2,693,000 | $2,625,000 | $68,000 | | Manufacturing and related costs | $3,313,000 | $1,914,000 | $1,399,000 | | Pre-clinical project costs | $21,000 | $183,000 | $(162,000) | | General R&D costs | $1,351,000 | $1,932,000 | $(581,000) | | **Total R&D Expense** | **$7,378,000** | **$6,654,000** | **$724,000** | - General and administrative expense increased by **$2.6 million** (**125%**) year-over-year, primarily due to costs associated with developing commercialization infrastructure[131](index=131&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q1 2024 with $40.0 million cash, sufficient to fund operations into Q4 2024, but requires additional funding for continued operations beyond that period - As of March 31, 2024, the company's consolidated cash balance was approximately **$40.0 million**[132](index=132&type=chunk) - The current cash balance is believed to be adequate to fund budgeted operations into the fourth quarter of 2024, but the company must raise additional capital to continue beyond that point[132](index=132&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2024, disclosure controls and procedures were deemed ineffective due to material weaknesses in fair value accounting, segregation of duties, and stock-based compensation controls, with remediation ongoing - Management concluded that disclosure controls and procedures were not effective as of March 31, 2024[135](index=135&type=chunk) - A material weakness was identified related to the failure to design and maintain effective controls for applying fair value methodologies to Level 3 instruments[136](index=136&type=chunk) - A material weakness exists due to a limited number of finance and accounting staff, making it difficult to maintain appropriate segregation of duties[137](index=137&type=chunk) - A material weakness was identified in the recording of stock-based compensation due to inadequately designed internal controls[138](index=138&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any legal proceedings anticipated to materially affect its financial statements - The company does not anticipate that the outcome of ordinary course legal matters and disputes will materially affect its financial statements[146](index=146&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) No new risk factors are disclosed; investors are directed to those previously outlined in the Annual Report on Form 10-K - The report refers to the Risk Factors previously disclosed in the Form 10-K filed with the SEC on March 27, 2024[147](index=147&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) The report includes required CEO and CFO certifications under Sarbanes-Oxley Sections 302 and 906, along with Interactive Data Files (XBRL) - Exhibits filed with the Form 10-Q include CEO and CFO certifications (Exhibits 31.1, 31.2, 32.1) and Interactive Data Files (Exhibits 101, 104)[153](index=153&type=chunk)

FLORHAM PARK, N.J., May 08, 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 Jarrod Longcor, chief operating officer of Cellectar, will present an overview of the company in a fireside chat at the upcoming Guggenheim Healthcare Talks Radiopharmaceuticals Day being held on May 13, 2024 in New York City. Details of the firesi ...

FLORHAM PARK, N.J., May 08, 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 Jarrod Longcor, chief operating officer of Cellectar, will present an overview of the company in a fireside chat at the upcoming Guggenheim Healthcare Talks Radiopharmaceuticals Day being held on May 13, 2024 in New York City. Details of the fires ...

FLORHAM PARK, N.J., May 07, 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 its financial results for the three months ended March 31, 2024, on Tuesday, May 14, 2024. Management will also host a conference call with investors to discuss financial results and provide an overview at 8:30 am Eastern Ti ...

FLORHAM PARK, N.J., May 07, 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 its financial results for the three months ended March 31, 2024, on Tuesday, May 14, 2024. Management will also host a conference call with investors to discuss financial results and provide an overview at 8:30 am Eastern T ...