Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 225, an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential to inhibit tumor growth and improve survival in pancreatic cancer models [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [6][7] Product Development - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 studies, demonstrating robust anti-tumor activity and selective biodistribution in preclinical models [1][3] - The studies involved three pancreatic cancer xenograft models (PANC-1, MIA PaCa-2, and BxPC-3), showing meaningful inhibition of tumor growth and potential survival benefits [2][3] Mechanism of Action - CLR 225 targets lipid rafts to deliver treatment directly to tumor cells, addressing the dense extracellular matrix characteristic of pancreatic cancer, which is a significant barrier to effective treatment [2][5] Market Context - Pancreatic ductal adenocarcinoma (PDAC) is a severe disease with less than 10% five-year survival rate, accounting for approximately 90% of pancreatic cancer cases in the U.S. [4]

Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 121225 (CLR 225), an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential for treating pancreatic ductal adenocarcinoma (PDAC) [1][2] - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 clinical trials [1][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [6][7] - The company's product pipeline includes CLR 121225 targeting pancreatic cancer, iopofosine I 131 for hematologic and solid tumors, and other preclinical PDC chemotherapeutic programs [7] Preclinical Data Highlights - CLR 225 demonstrated robust anti-tumor activity and selective biodistribution in three pancreatic cancer xenograft models, showing meaningful tumor growth inhibition and potential survival benefits [2][3] - The compound was well-tolerated across all dosing levels, with no adverse effects noted in body weight or animal health [2] Mechanism of Action - CLR 225 targets lipid rafts to deliver treatment directly to tumor cells, addressing the dense extracellular matrix characteristic of pancreatic cancer, which is a significant barrier to effective treatment [2][5] Market Context - PDAC is a severe disease with less than 10% survival after five years, accounting for approximately 90% of the 67,500 new pancreatic cancer cases in the U.S. annually [4]

[Series II Common Stock Purchase Warrant](index=1&type=section&id=Series%20II%20Common%20Stock%20Purchase%20Warrant) This document outlines the terms and conditions of the Series II Common Stock Purchase Warrant issued by Cellectar Biosciences, Inc. [Warrant Details](index=1&type=section&id=Warrant%20Details) This section introduces the Series II Common Stock Purchase Warrant issued by Cellectar Biosciences, Inc., outlining the initial exercise date, termination date, and the company's common stock purchase terms - The warrant allows the holder to subscribe for and purchase Common Stock from Cellectar Biosciences, Inc. between the **Initial Exercise Date of October 8, 2025**, and the **Termination Date of April 8, 2027**[3](index=3&type=chunk) [Section 1. Definitions](index=1&type=section&id=Section%201.%20Definitions) This section defines key legal and financial terms to ensure consistent interpretation throughout the warrant document [Key Terms Defined](index=1&type=section&id=Key%20Terms%20Defined) This section provides definitions for key terms used throughout the warrant document, ensuring clarity and consistent interpretation of legal and financial concepts - Key definitions include **'Affiliate'**, **'Bid Price'**, **'Business Day'**, **'Common Stock'**, **'Common Stock Equivalents'**, **'Trading Market'** (e.g., NYSE American, Nasdaq, OTCQB/OTCQX), **'Transfer Agent'**, and **'VWAP'** (Volume Weighted Average Price)[4](index=4&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk)[15](index=15&type=chunk)[16](index=16&type=chunk) - The **'Warrants'** refer to this specific Series II Common Stock purchase warrant and other similar warrants issued by the Company[17](index=17&type=chunk) [Section 2. Exercise](index=3&type=section&id=Section%202.%20Exercise) This section details the procedures, pricing, and limitations for exercising the Series II Common Stock Purchase Warrant [a) Exercise of Warrant](index=3&type=section&id=a)%20Exercise%20of%20Warrant) This subsection details the procedure for exercising the warrant, allowing for whole or partial exercise at any time between the Initial Exercise Date and the Termination Date via email submission of a Notice of Exercise - Exercise can be made in whole or in part by delivering a duly executed **PDF copy of the Notice of Exercise via email**[18](index=18&type=chunk) - The aggregate Exercise Price must be delivered within **one Trading Day** or the **Standard Settlement Period**, unless a cashless exercise is specified[18](index=18&type=chunk) [b) Exercise Price](index=4&type=section&id=b)%20Exercise%20Price) This section specifies the initial exercise price per share of Common Stock, subject to future adjustments as outlined in the warrant Exercise Price | Item | Value | | :------------ | :------ | | Exercise Price | $6.00 | [c) Cashless Exercise](index=4&type=section&id=c)%20Cashless%20Exercise) This subsection describes the cashless exercise mechanism, which allows the holder to receive Warrant Shares without a cash payment if no effective registration statement is available for resale, using a specific formula based on VWAP and the Exercise Price - Cashless exercise is available if there is **no effective registration statement** for the resale of Warrant Shares[21](index=21&type=chunk) - The number of Warrant Shares received is calculated by dividing **[(VWAP - Exercise Price) \* Number of Cash Exercise Shares] by VWAP**[21](index=21&type=chunk)[23](index=23&type=chunk) [d) Mechanics of Exercise](index=5&type=section&id=d)%20Mechanics%20of%20Exercise) This section outlines the practical aspects of exercising the warrant, including the delivery of shares, handling of partial exercises, rescission rights, compensation for delivery failures, and treatment of fractional shares and expenses - Warrant Shares are to be transmitted by the Transfer Agent via **DWAC or physical certificate** within **one Trading Day** or the **Standard Settlement Period** after Notice of Exercise[24](index=24&type=chunk) - Failure to deliver shares by the Warrant Share Delivery Date incurs liquidated damages of **$10 per Trading Day** for each **$1,000 of Warrant Shares**[24](index=24&type=chunk) - Holders have **rescission rights** and **compensation for 'Buy-In' costs** if the Company fails to timely deliver Warrant Shares[27](index=27&type=chunk)[28](index=28&type=chunk) - No fractional shares are issued; the Company will either pay a **cash adjustment** or **round up to the next whole share**[30](index=30&type=chunk) - The Company is responsible for all **issue or transfer taxes** and **Transfer Agent fees** related to the issuance of Warrant Shares[31](index=31&type=chunk) [e) Holder's Exercise Limitations](index=8&type=section&id=e)%20Holder's%20Exercise%20Limitations) This subsection imposes a beneficial ownership limitation on the holder, restricting the exercise of the warrant if it would result in the holder (and affiliates) owning more than a specified percentage of the Company's outstanding Common Stock - The Beneficial Ownership Limitation is **4.99%** (or **9.99% upon election**) of the outstanding Common Stock immediately after exercise[34](index=34&type=chunk) - The Holder is responsible for determining compliance with this limitation and for any required **Section 13(d) filings**[34](index=34&type=chunk) [Section 3. Certain Adjustments](index=9&type=section&id=Section%203.%20Certain%20Adjustments) This section describes various adjustments to the warrant's terms, including those related to stock events and corporate transactions [a) Stock Dividends and Splits](index=9&type=section&id=a)%20Stock%20Dividends%20and%20Splits) This subsection details how the Exercise Price and the number of Warrant Shares will be adjusted in response to stock dividends, subdivisions, combinations (splits), or reclassifications of the Company's Common Stock - The Exercise Price and number of Warrant Shares will be **proportionately adjusted** for stock dividends, splits, combinations, or reclassifications to keep the aggregate Exercise Price unchanged[36](index=36&type=chunk) [b) Subsequent Rights Offerings](index=9&type=section&id=b)%20Subsequent%20Rights%20Offerings) This section grants the Holder the right to acquire Purchase Rights offered pro rata to Common Stock holders, as if the warrant had been fully exercised prior to such offering, subject to the Beneficial Ownership Limitation - Holder is entitled to acquire **Purchase Rights** offered pro rata to Common Stock holders, as if the warrant was fully exercised, subject to the Beneficial Ownership Limitation[37](index=37&type=chunk) [c) Dividends and Distributions](index=9&type=section&id=c)%20Dividends%20and%20Distributions) This subsection restricts the Company from paying cash dividends or making other asset distributions to capital stock holders prior to the Termination Date, with an exception for bankruptcy or dissolution, and requires prior notice for cash dividends - The Company must provide **90 days' prior written notice** for any cash dividend to capital stock holders[38](index=38&type=chunk) - No other asset distributions are permitted prior to the Termination Date, except in cases of **bankruptcy or dissolution**[38](index=38&type=chunk) [d) Fundamental Transaction](index=10&type=section&id=d)%20Fundamental%20Transaction) This section defines various corporate actions as 'Fundamental Transactions' and outlines the Holder's rights upon such an event, including receiving alternate consideration or having the Company/Successor Entity purchase the warrant at its Black Scholes Value - A **'Fundamental Transaction'** includes mergers, asset sales, tender offers, reclassifications, or business combinations where **over 50% of Common Stock or voting power is acquired**[40](index=40&type=chunk) - Upon a Fundamental Transaction, the Holder can choose to receive **Alternate Consideration** or have the Company/Successor Entity purchase the warrant at its **Black Scholes Value**[40](index=40&type=chunk)[41](index=41&type=chunk) - The Black Scholes Value is determined using the **Black-Scholes Option Pricing Model**, considering factors like risk-free interest rate, volatility, underlying price, and remaining option time[40](index=40&type=chunk) [e) Calculations](index=12&type=section&id=e)%20Calculations) This subsection specifies the precision for all calculations under Section 3 and defines how the number of outstanding Common Stock shares is determined - All calculations under Section 3 are to be made to the **nearest cent or 1/100th of a share**[42](index=42&type=chunk) [f) Notice to Holder](index=12&type=section&id=f)%20Notice%20to%20Holder) This section mandates the Company to provide timely email notices to the Holder regarding adjustments to the Exercise Price and significant corporate events that may affect the Common Stock or the warrant's exercise - The Company must promptly notify the Holder by email of any **Exercise Price adjustments** and the facts requiring such adjustment[43](index=43&type=chunk) - The Company must provide at least **20 calendar days' notice** for events like dividends, redemptions, rights offerings, reclassifications, mergers, or dissolution[44](index=44&type=chunk) - Any notice containing material, non-public information must be filed with the SEC via **Form 8-K**[44](index=44&type=chunk) [g) Voluntary Adjustment By Company](index=13&type=section&id=g)%20Voluntary%20Adjustment%20By%20Company) This subsection grants the Company's board of directors the discretion to voluntarily reduce the Exercise Price for any period, subject to Trading Market rules and regulations - The Company's board of directors may **voluntarily reduce the Exercise Price** at any time during the warrant's term, subject to Trading Market rules[46](index=46&type=chunk) [Section 4. Transfer of Warrant](index=13&type=section&id=Section%204.%20Transfer%20of%20Warrant) This section specifies the conditions and procedures for transferring the warrant, including registration and holder representations [a) Transferability](index=13&type=section&id=a)%20Transferability) This subsection outlines the conditions and procedures for transferring the warrant, in whole or in part, including the requirement for a written assignment and payment of transfer taxes - The warrant is transferable, in whole or in part, upon surrender of the warrant with a **duly executed written assignment** and payment of any transfer taxes[47](index=47&type=chunk) [b) New Warrants](index=14&type=section&id=b)%20New%20Warrants) This subsection describes the process for dividing or combining warrants, allowing for the issuance of new warrants with specified denominations upon presentation and notice - Warrants may be divided or combined, resulting in **new warrants dated the Initial Exercise Date** and identical except for the number of Warrant Shares[49](index=49&type=chunk) [c) Warrant Register](index=14&type=section&id=c)%20Warrant%20Register) This subsection states that the Company will maintain a Warrant Register to record the holder of the warrant and will treat the registered holder as the absolute owner for all purposes - The Company will maintain a **'Warrant Register'** and treat the registered Holder as the absolute owner for exercise and distribution purposes[50](index=50&type=chunk) [d) Representation by the Holder](index=14&type=section&id=d)%20Representation%20by%20the%20Holder) This subsection includes a representation by the Holder that the warrant and any acquired Warrant Shares are for their own account and not for distribution or resale in violation of securities laws - By accepting the warrant, the Holder represents that they are acquiring it and the Warrant Shares for their **own account**, not for distribution or resale in violation of securities laws[51](index=51&type=chunk) [Section 5. Miscellaneous](index=14&type=section&id=Section%205.%20Miscellaneous) This section addresses general legal provisions, including stockholder rights, loss procedures, governing law, and remedies [a) No Rights as Stockholder Until Exercise; No Settlement in Cash](index=14&type=section&id=a)%20No%20Rights%20as%20Stockholder%20Until%20Exercise%3B%20No%20Settlement%20in%20Cash) This subsection clarifies that the Holder does not have stockholder rights (e.g., voting, dividends) until the warrant is exercised, and the Company is not required to net cash settle an exercise - The Holder does not have **voting rights, dividends, or other stockholder rights** prior to the exercise of the warrant, except as expressly set forth in Section 3[52](index=52&type=chunk) - The Company is not required to **net cash settle** an exercise of this Warrant[52](index=52&type=chunk) [b) Loss, Theft, Destruction or Mutilation of Warrant](index=14&type=section&id=b)%20Loss%2C%20Theft%2C%20Destruction%20or%20Mutilation%20of%20Warrant) This subsection outlines the Company's covenant to issue a new warrant or stock certificate if the original is lost, stolen, destroyed, or mutilated, upon satisfactory evidence and indemnity - The Company will issue a **new warrant or stock certificate** upon satisfactory evidence of loss, theft, destruction, or mutilation, and appropriate indemnity[53](index=53&type=chunk) [c) Saturdays, Sundays, Holidays, etc.](index=15&type=section&id=c)%20Saturdays%2C%20Sundays%2C%20Holidays%2C%20etc.) This subsection specifies that if any required action or right expiration falls on a non-Business Day, it may be taken or exercised on the next succeeding Business Day - If an action or right expiration falls on a **non-Business Day**, it may be taken or exercised on the **next Business Day**[55](index=55&type=chunk) [d) Authorized Shares](index=15&type=section&id=d)%20Authorized%20Shares) This subsection details the Company's covenants regarding authorized shares, including reserving sufficient shares for warrant exercise, ensuring valid and fully paid issuance, and taking actions to protect the Holder's rights against impairment - The Company covenants to **reserve sufficient authorized and unissued Common Stock** for the issuance of Warrant Shares upon exercise[56](index=56&type=chunk) - The Company will ensure Warrant Shares are **duly authorized, validly issued, fully paid, nonassessable, and free from Company-created taxes, liens, and charges**[56](index=56&type=chunk) - The Company agrees not to take actions that would **avoid or impair the terms of the Warrant** and will assist in protecting the Holder's rights[57](index=57&type=chunk) [e) Governing Law](index=16&type=section&id=e)%20Governing%20Law) This subsection establishes that the warrant will be governed by New York law and that all legal proceedings will be exclusively commenced in New York City courts - The warrant is governed by the **internal laws of the State of New York**[60](index=60&type=chunk) - All legal proceedings related to the warrant will be exclusively commenced in **state and federal courts in New York City**[60](index=60&type=chunk) [f) Restrictions](index=16&type=section&id=f)%20Restrictions) This subsection informs the Holder that Warrant Shares acquired upon exercise, if not registered and cashless exercise is not utilized, will be subject to resale restrictions under state and federal securities laws - Warrant Shares acquired upon exercise, if not registered and cashless exercise is not used, will have **resale restrictions under state and federal securities laws**[61](index=61&type=chunk) [g) Nonwaiver and Expenses](index=16&type=section&id=g)%20Nonwaiver%20and%20Expenses) This subsection states that no delay or failure to exercise rights by the Holder constitutes a waiver, and the Company will reimburse the Holder for costs and expenses, including attorney's fees, if it willfully fails to comply with the warrant's provisions - No delay or failure by the Holder to exercise any right constitutes a **waiver**[62](index=62&type=chunk) - If the Company willfully and knowingly fails to comply, resulting in material damages, it must pay the Holder's **costs and expenses, including reasonable attorneys' fees**[62](index=62&type=chunk) [h) Notices](index=17&type=section&id=h)%20Notices) This subsection specifies the methods for delivering notices between the Company and the Holder, including personal delivery, email, or overnight courier, and defines when such notices are deemed effective - Notices can be delivered **personally, by e-mail, or via nationally recognized overnight courier service**[64](index=64&type=chunk) - Notices are deemed effective at the **time of transmission** (for e-mail during business hours), the **next Trading Day** (for e-mail outside business hours), the **second Trading Day after mailing**, or upon **actual receipt**[64](index=64&type=chunk) - Any notice containing material, non-public information must be simultaneously filed with the Commission via a **Current Report on Form 8-K**[64](index=64&type=chunk) [i) Limitation of Liability](index=17&type=section&id=i)%20Limitation%20of%20Liability) This subsection clarifies that the Holder incurs no liability for the purchase price of Common Stock or as a stockholder of the Company merely by holding the warrant, prior to its exercise - Holding the warrant does not create liability for the Holder for the **purchase price of Common Stock** or as a **stockholder of the Company** prior to exercise[65](index=65&type=chunk) [j) Remedies](index=17&type=section&id=j)%20Remedies) This subsection grants the Holder the right to specific performance for breaches of the warrant's provisions, with the Company waiving the defense that monetary damages would be adequate - The Holder is entitled to **specific performance** of its rights under the Warrant[66](index=66&type=chunk) - The Company waives the defense that a **remedy at law (monetary damages)** would be adequate[66](index=66&type=chunk) [k) Successors and Assigns](index=17&type=section&id=k)%20Successors%20and%20Assigns) This subsection states that the warrant's rights and obligations benefit and bind the successors and permitted assigns of both the Company and the Holder, and are enforceable by any Holder - The warrant's rights and obligations benefit and bind the **successors and permitted assigns** of both the Company and the Holder[67](index=67&type=chunk) [l) Amendment](index=17&type=section&id=l)%20Amendment) This subsection specifies that the warrant can only be modified, amended, or its provisions waived with the written consent of both the Company and the Holder - The Warrant can only be **modified, amended, or its provisions waived** with the **written consent of the Company and the Holder**[68](index=68&type=chunk) [m) Severability](index=18&type=section&id=m)%20Severability) This subsection ensures that if any provision of the warrant is found to be prohibited or invalid under applicable law, it will be ineffective only to that extent, without invalidating the remaining provisions - If any provision is prohibited or invalid under applicable law, it is **ineffective only to that extent**, without invalidating the rest of the warrant[70](index=70&type=chunk) [n) Headings](index=18&type=section&id=n)%20Headings) This subsection clarifies that the headings used in the warrant are for convenience of reference only and do not constitute a part of the warrant's substantive terms - Headings are for **convenience of reference only** and are not considered part of the Warrant[71](index=71&type=chunk) [Signature Page](index=19&type=section&id=Signature%20Page) This page serves as the formal execution section where Cellectar Biosciences, Inc. officially signs the warrant through an authorized officer [Company Execution](index=19&type=section&id=Company%20Execution) This page serves as the formal execution section where Cellectar Biosciences, Inc. officially signs the warrant through an authorized officer - The Company, Cellectar Biosciences, Inc., executes the Warrant through an **authorized officer**[73](index=73&type=chunk)[74](index=74&type=chunk) [NOTICE OF EXERCISE Form](index=20&type=section&id=NOTICE%20OF%20EXERCISE%20Form) This section provides the template for the 'Notice of Exercise' form, used by the Holder to formally elect to purchase Warrant Shares [Exercise Form Details](index=20&type=section&id=Exercise%20Form%20Details) This section provides the template for the 'Notice of Exercise' form, which the Holder uses to formally elect to purchase Warrant Shares, specifying payment method and delivery instructions - The form allows the undersigned to elect to purchase Warrant Shares, specifying the **number of shares**[76](index=76&type=chunk) - Payment can be made in **lawful money** or through a **cashless exercise**, if permitted[77](index=77&type=chunk) - The form requires delivery instructions for the Warrant Shares, including a **DWAC Account Number**, and a representation that the undersigned is an **'accredited investor'**[78](index=78&type=chunk) [ASSIGNMENT FORM](index=21&type=section&id=ASSIGNMENT%20FORM) This section presents the 'Assignment Form' template, used by a Holder to assign the warrant and all associated rights to another party [Warrant Assignment Form](index=21&type=section&id=Warrant%20Assignment%20Form) This section presents the 'Assignment Form' template, used by a Holder to assign the warrant and all associated rights to another party, requiring the assignee's details and the Holder's signature - The form is used to **assign the warrant and all rights to a new party**[82](index=82&type=chunk) - It requires the **name, address, phone number, and email address of the assignee**, along with the **Holder's signature and address**[82](index=82&type=chunk)

Core Insights - The article discusses the importance of enabling Javascript and cookies in browsers to ensure proper functionality and access to content [1] Group 1 - The article highlights that users may face access issues if ad-blockers are enabled, suggesting the need to disable them for a better experience [1]

Core Viewpoint - Cellectar Biosciences, Inc. has entered into an agreement with institutional investors to exercise existing warrants, generating approximately $5.8 million in gross proceeds for the company [1][2]. Group 1: Financial Details - The company will receive gross proceeds of approximately $5.8 million from the exercise of 1,048,094 existing warrants at an exercise price of $5.25 each [1][2]. - The new warrants issued will include 1,048,094 Series I and 1,048,094 Series II warrants, with an exercise price of $6.00 per share [3]. - The Series I warrants have a five-year term, while the Series II warrants have an 18-month term from the date of initial exercise [3]. Group 2: Use of Proceeds - The net proceeds from this offering will be utilized for working capital, general corporate purposes, and specifically for the Phase 1b clinical study of CLR 121125 in triple-negative breast cancer [4]. Group 3: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform [7]. - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors and designed to improve efficacy and safety [8].

Core Viewpoint - Cellectar Biosciences is preparing to submit a Conditional Marketing Authorization (CMA) application for iopofosine I 131 as a treatment for refractory Waldenstrom macroglobulinemia (WM), with potential European approval and commercial launch expected in 2027 [1][4]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [14][15]. Product Details - Iopofosine I 131 is a novel cancer-targeting agent designed for post-BTKi refractory WM patients, having received PRIME designation from the EMA for patients who have undergone at least two prior lines of therapy [2][11]. - The drug has demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER WaM Phase 2 study [4][6]. Regulatory Pathway - The decision to file for CMA follows advice from the Scientific Advice Working Party (SAWP) of the EMA, which indicated that the data supports the eligibility for CMA submission for the specified patient population [3][8]. - CMA allows for earlier access to medicines addressing unmet medical needs, permitting approval based on less comprehensive clinical data [8]. Market Opportunity - There is a significant unmet medical need for WM treatment in Europe, affecting an estimated 35,000 to 45,000 patients [3][12]. - The company believes that iopofosine I 131 presents a substantial market opportunity due to its compelling patient outcomes and regulatory designations [5][12]. Future Plans - The company plans to pursue worldwide approval, including a New Drug Application (NDA) with the U.S. FDA under an accelerated approval pathway, contingent upon obtaining additional funding for a confirmatory study [4][6]. - The U.S. NDA will be supported by data from the Phase 2b CLOVER WaM clinical trial, which includes FDA-requested follow-up results [6][7].

Core Insights - Cellectar Biosciences announced promising interim results from the CLOVER-2 Phase 1b clinical study of iopofosine I 131, showing extended progression-free survival (PFS) and overall survival (OS) in pediatric patients with relapsed or refractory high-grade gliomas [1][3][4] Study Details - The CLOVER-2 trial involves children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas, focusing on safety, tolerability, and therapeutic activity of iopofosine I 131 [10] - Patients in the study experienced an average PFS of 5.4 months and OS of 8.6 months, with those receiving additional dosing cycles showing even better outcomes [4][7] Patient Outcomes - Two case studies highlighted significant tumor volume reduction and extended survival in patients treated with iopofosine I 131, with one patient achieving a PFS of 10.9 months and ongoing survival exceeding 18 months [5][6] - The safety profile of iopofosine I 131 was consistent with previous data, showing no severe toxicities and manageable hematologic adverse events [7] Regulatory Designations - The FDA has granted iopofosine I 131 several designations, including Rare Pediatric Drug and Orphan Drug status, indicating its potential as a significant treatment option for pediatric high-grade gliomas [2][13] Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate delivery platform to enhance efficacy and safety [11][12]

Core Insights - Cellectar Biosciences intends to initiate a Phase 1b clinical trial for CLR 125, targeting triple-negative breast cancer (TNBC), at the Mayo Clinic in the fourth quarter of 2025 [1][3] - Evestia Clinical will provide comprehensive CRO services for this trial, leveraging its expanded capabilities following a merger with Atlantic Research Group [2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [7][8] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [8][9] Clinical Trial Details - The Phase 1b trial will evaluate CLR 125, an iodine-125 Auger-emitting drug candidate, specifically for TNBC, which is known for its aggressive nature and limited treatment options [1][4] - The trial will be led by Pooja Advani, MBBS, MD, at a Mayo Clinic Network site, ensuring high-quality clinical oversight [3] Industry Context - TNBC accounts for approximately 12% of breast cancer diagnoses in the U.S., with a high recurrence rate of about 25% (40,540 cases) after standard treatments [4] - There is a critical need for innovative therapies in TNBC due to its poor prognosis and rapid progression [4] Evestia Clinical Overview - Evestia Clinical is a global specialist CRO that partners with biotech companies to accelerate the development of life-saving therapies, offering a full suite of customized clinical development services [5][6] - The merger with Atlantic Research Group has enhanced Evestia's oncology expertise and expanded its U.S. presence [2][3]

Core Viewpoint - Cellectar Biosciences and ITM Isotope Technologies Munich have entered a supply agreement for Actinium-225 to support the clinical development of Cellectar's CLR 121225, a novel radiopharmaceutical for treating solid tumors, including pancreatic cancer [1][2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate delivery platform [5] - ITM Isotope Technologies Munich SE specializes in radiopharmaceuticals and aims to provide innovative therapeutics and diagnostics for hard-to-treat tumors, leveraging over two decades of expertise in medical isotope manufacturing [9] Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and CLR 121225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [6][7] - CLR 121225 is designed to selectively target and eradicate cancer cells using a proprietary PLE delivery platform [2][6] Strategic Partnership - The agreement between Cellectar and ITM ensures a continuous, high-quality supply of Actinium-225, which is crucial for advancing Cellectar's pipeline candidates and exploring the benefits of targeted alpha therapy for cancer patients [3][4] - ITM's joint venture, Actineer, is dedicated to advancing Ac-225 technologies and aims to meet the growing global demand for this critical isotope [10] Market Context - The scarcity of high-quality Ac-225 has hindered the development of Ac-225 based programs, prompting Cellectar to establish a network of suppliers to ensure sufficient access [3][4] - The partnership reflects a strategic commitment to enhancing global access to radiopharmaceuticals and improving patient outcomes through innovative therapies [4]

Core Insights - Cellectar Biosciences is making progress with the European Medicines Agency (EMA) regarding a potential Conditional Marketing Authorization (CMA) submission for Iopofosine I 131 to treat Waldenstrom Macroglobulinemia (WM), with a decision expected in late Q3 or early Q4 2025 [1][3] - The company intends to pursue an accelerated approval with the U.S. Food and Drug Administration (FDA) for Iopofosine I 131 as a treatment for WM, contingent on raising sufficient funding and the initiation of a confirmatory trial [2][3] - Cellectar is advancing its Auger-emitting radiopharmaceutical candidate, CLR 125, into a Phase 1b clinical trial for the treatment of triple-negative breast cancer (TNBC) planned for Q4 2025 [1][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate (PDC) delivery platform [3][4] - The company's product pipeline includes Iopofosine I 131, CLR 121225 (an actinium-225 based program), and CLR 121125 (an iodine-125 Auger-emitting program) targeting various solid tumors [5] Clinical Trials and Regulatory Progress - Data from the Phase 2b CLOVER WaM clinical trial for Iopofosine I 131 showed a statistically significant major response rate and meaningful duration of response, supporting the CMA submission to the EMA [3][6] - The FDA has granted Iopofosine I 131 multiple designations, including six Orphan Drug and four Rare Pediatric Drug designations, indicating its potential in treating various cancer indications [6] Future Plans - The company plans to share new data from the Phase 2b trial at an upcoming medical or scientific conference, which includes 12-month follow-up results and subset analyses [3] - Cellectar is executing long-term supply agreements for iodine-125 and actinium-225 to support its clinical studies and future commercial needs [3]