On January 13, 2025 ADC Therapeutics presented its corporate presentation (Presentation, ADC Therapeutics, JAN 13, 2025, View Source [SID1234649632]).

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On January 13, 2025 Aclaris therapeutics presented its corporate presentation (Presentation, Aclaris Therapeutics, JAN 13, 2025, View Source [SID1234649631]).

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On January 13, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases, reported key objectives and anticipated milestones for 2025, which will be the subject of Nurix’s corporate update at the 43rd Annual J.P. Morgan Healthcare Conference today at 3:00 p.m. PT, in San Francisco (Press release, Nurix Therapeutics, JAN 13, 2025, View Source [SID1234649629]).

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"Nurix had an exciting year of successful execution of our clinical trials and significant progress in several key business areas," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We recently presented impressive clinical responses from our NX-5948 Phase 1a/1b clinical trial both in patients with relapsed or refractory chronic lymphocytic leukemia and in patients with Waldenstrom’s macroglobulinemia. We received Fast Track Designation from the U.S. Food and Drug Administration for both of these indications as well as PRIME designation for CLL from the European Medicines Agency. Nurix is positioned to initiate a suite of late-stage clinical studies of NX-5948 in 2025, including pivotal studies in CLL. We also anticipate significant advances in our portfolio of wholly owned and partnered programs in the area of inflammation and immunology, including degraders of IRAK4 and STAT6."

"2024 was a year of significant advancement in our research and discovery organization," said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. "We not only advanced several preclinical programs that are approaching key development milestones within our wholly owned and partnered portfolios, but we also expanded our discovery platform to include AI-powered drug discovery that leverages our early investments in E3 ligase research, DEL discovery, chemistry automation and machine learning. Nurix has developed a suite of AI tools applicable across the breadth of our technical workflows, but with a specific focus on prospective ligand discovery informed by our years of accumulated DEL know-how and screening data, which we are calling DEL-AI."

2024 Accomplishments and Business Highlights

Clinical Development Pipeline

Advanced NX-5948 and presented positive clinical data at oncology-focused medical meetings throughout 2024. New positive clinical data were presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH2024) in December 2024 and at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) in October 2024, from patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL) and patients with Waldenstrom’s macroglobulinemia (WM) treated in the Phase 1a/1b clinical trial of NX-5948. NX-5948 is an orally bioavailable, brain penetrant degrader of Bruton’s tyrosine kinase (BTK). At ASH (Free ASH Whitepaper)2024, Nurix reported a robust objective response rate (ORR) of 75.5% among the 49 efficacy-evaluable r/r CLL patients across all doses tested, with the majority of responses occurring at the first assessment (Week 8). With longer time on treatment, the ORR increased to 84.2% based on an exploratory efficacy analysis of patients who had at least two response assessments (Week 16). Responses and robust BTK degradation were observed across all populations regardless of prior treatment, baseline mutations including those with BTK mutations associated with treatment resistance to both covalent and non-covalent BTK inhibitors, high-risk molecular features, or central nervous system (CNS) involvement. NX-5948 was well-tolerated in all patient populations and across all doses tested from 50 to 600 mg daily. In the nine efficacy-evaluable WM patients treated with NX-5948 an ORR of 77.8% was observed with increasing depth of response over time, supporting continued development of NX-5948 for this indication. Additional information on the ongoing clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022). A webcast of Nurix’s ASH (Free ASH Whitepaper)2024 presentation and additional discussion on the company’s programs and plans is available in the Investors section of the Nurix website.
Successfully executed on regulatory strategy for global development of NX-5948 with U.S. FDA Fast Track and European Medicines Agency PRIME designations: In 2024, NX-5948 received two separate Fast Track designations from the U.S. Food and Drug Administration (FDA): the first for the treatment of adult patients with r/r CLL/SLL after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, and the second for the treatment of adult patients with r/r WM after at least two lines of therapy, including a BTK inhibitor. In Europe, NX-5948 received PRIME designation for the treatment patients with r/r CLL/SLL after treatment with at least a BTK inhibitor and a BCL2 inhibitor. Regulatory clearance for clinical site initiations was received in several countries and clinical trial expansion is ongoing in France, Poland, Italy and Spain. Additional countries are anticipated to come online in 2025.
Re-initiated enrollment in NX-2127 Phase 1a/b trial: Following a decision in March 2024 in which the FDA lifted a manufacturing-related, partial clinical hold on the NX-2127 clinical trial, Nurix reinitiated enrollment in a dose escalation study within the current Phase 1a/1b trial, using its new chirally controlled drug product of NX-2127, a novel orally bioavailable bifunctional molecule that degrades BTK and the cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). Nurix is focusing development on aggressive lymphomas where the combination of BTK degradation and IKZF1/3 degradation have the potential for synergy and significant therapeutic benefit. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
Advanced Phase 1a dose escalation trial of NX-1607 in monotherapy and in a combination cohort with paclitaxel in adults in a range of oncology indications. Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B) for immuno-oncology indications, including a range of solid tumor types. The company has evaluated dosing and scheduling regimens to optimize tolerability and maximize pharmacodynamic effects. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
Research and Discovery

Advanced a pipeline of wholly owned and partnered programs in inflammation and immunology: At ACR Convergence 2024, the annual meeting of the American College of Rheumatology, Nurix presented preclinical data, including mechanism of action and activity in relevant disease models of inflammation and autoimmune diseases, from NX-5948. Nurix announced plans to initiate clinical testing of NX-5948 in autoimmune cytopenias such as warm autoimmune hemolytic anemia (wAIHA) in 2025, initially as an addition to its ongoing Phase 1b trial in patients with B-cell malignancies. At ACR Convergence 2024, positive preclinical data were also presented from Nurix’s collaboration with Gilead to develop GS-6791/NX-0479, an IRAK4 degrader, that has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. In addition, Nurix’s ongoing research program with Sanofi was extended for the development of a degrader of STAT6 (signal transducer and activator of transcription 6), a key drug target in type 2 inflammation, with the goal of nominating a development candidate in the first half of 2025.
Expanded Nurix’s portfolio of brain penetrant degraders: At the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2024, Nurix presented the first clinical evidence of brain penetration and clinical activity in the CNS for its BTK degrader NX-5948. In addition, data from Nurix’s previously undisclosed program to develop an orally available, brain penetrant pan-mutant B-RAF degrader for the treatment of mutant B-RAF driven solid tumors were presented at the 7th Annual TPD & Induced Proximity Summit. These programs, along with other scientific presentations throughout 2024, clearly demonstrate Nurix’s ability to achieve brain penetrant and CNS active degraders.
Published the first description of BTK’s clinically important scaffolding function: Nurix scientists and clinical collaborators published a manuscript in the journal Science titled "Kinase Impaired BTK Mutations Are Susceptible to Clinical Stage BTK and IKZF1/3 Degrader NX-2127" that elucidates a previously unappreciated oncogenic scaffold function of BTK responsible for clinical resistance to enzymatic inhibitors and shows that NX-2127, a potent targeted protein degrader with differentiated activity against BTK and IKZF1/3, can overcome this resistance across a broad range of acquired mutations. The elimination of BTK’s scaffolding function is a critical attribute of both NX-2127 and NX-5948, with potential clinical relevance in both B-cell malignancies and inflammation.
Demonstrated cellular proof of concept for its degrader antibody conjugate (DAC) platform: Early preclinical data from Nurix’s ongoing collaboration with Pfizer to develop DACs were presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit. The data from two separate DACs demonstrated cell-type selective degradation of targeted proteins by DACs and highlighted the potential advantages of this new drug class and Nurix’s novel approach to DAC optimization.
Achieved significant milestones in collaborations with Gilead, Sanofi and Pfizer: In April 2024, Nurix announced that Gilead elected to extend the research term of the companies’ ongoing collaboration, originally established in 2019, by an additional two years, which resulted in a payment of $15 million to Nurix. In April 2024, Nurix also announced the extension of its research term with Sanofi for its previously undisclosed STAT6 degrader program. In 2024, Nurix also achieved its first milestone in its ongoing Pfizer collaboration and received a $5 million payment. In total, in 2024, Nurix earned milestones and fees in these ongoing strategic collaborations totaling $22 million through the third fiscal quarter of 2024 (August 31, 2024).
Corporate and Leadership

Strengthened leadership team with C-suite appointments and new Board of Directors member with drug commercialization expertise: In 2024, Nurix announced the promotions of Paula G. O’Connor, M.D., as chief medical officer and Pasit Phiasivongsa, Ph.D., as chief technical officer of Nurix. These appointments strengthen leadership in clinical operations and CMC ahead of planned pivotal studies for NX-5948 in 2025. In addition, Anil Kapur, a senior leader in commercial operations in hematology and oncology with over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets joined the Nurix board of directors.
Strengthened balance sheet to support development of pipeline: Nurix ended its fiscal year with an estimated, unaudited $609.6 million in cash and investments as of November 30, 2024.* Based on its operating plan, Nurix anticipates that the company will be able to fund its operating activities into the first half of 2027.
2025 Goals and Catalysts

NX-5948
Initiate pivotal studies for NX-5948: Nurix is evaluating NX-5948 in an ongoing Phase 1b clinical trial in adults with relapsed or refractory B-cell malignancies and expects to initiate a suite of clinical trials in 2025 intended to support global registration of NX-5948 for the treatment of patients with CLL.
Expand the development of NX-5948 in additional cancer indications and inflammatory diseases: Nurix expects to complete the ongoing Phase 1b clinical trial in patients with WM and determine Phase 2 dose(s) as well as to continue to explore regulatory paths for this indication. In inflammation and immunology (I&I), Nurix plans to implement a sequenced, multi-organ system approach to evaluating NX-5948 to generate the greatest opportunity for patients and value creation, seeking first proof of concept through the study of CLL patients with secondary autoimmune-mediated hemolytic anemia with plans to explore non-malignant cytopenias, such as warm autoimmune hemolytic anemia (wAIHA), before potentially moving to dermatologic indications, such as hidradenitis suppurativa (HS), and neurologic indications, such as multiple sclerosis (MS).
NX-2127
Drive NX-2127 to proof-of-concept data: Nurix is focusing development on aggressive lymphomas where the combination of BTK degradation and IKZF1/3 degradation have the potential for synergy and significant therapeutic benefit. The company plans to complete dose escalation with new chirally controlled drug product and select recommended Phase 1b dose for selected indications and expects to share additional clinical data after selection of a Phase 1b expansion dose(s) and indication(s).
NX-1607:
Drive NX-1607 to proof-of-concept data: Nurix is testing both once daily (QD) and twice daily (BID) dosing of NX-1607. With additional patients in the BID dosing arms, Nurix plans to establish a Phase 1b monotherapy dose and expects to share additional clinical data after selection of a Phase 1b expansion dose(s) and indication(s).
Preclinical-development pipeline:
Advance IRAK4 degrader program into Phase 1: GS-6791 (previously NX-0479) is a potent, selective, oral IRAK4 degrader. Nurix’s partner Gilead exercised its option to exclusively license GS-6791 in March 2023 and is responsible for conducting IND-enabling studies and advancing this program to clinical development, which Nurix anticipates in 2025. Nurix retains its option to co-develop and co-promote in the United States, splitting U.S profits and losses evenly and receiving royalties on ex-U.S. sales.
Nominate a STAT6 degrader development candidate: Nurix anticipates nominating a STAT6 degrader development candidate in the first half of 2025. Under its collaboration with Sanofi, delivery of a development candidate data package triggers a licensing option decision for Sanofi. If licensed by Sanofi, Nurix retains its option to co-develop and co-promote in the United States, splitting U.S profits and losses evenly and receiving royalties on ex-U.S. sales.
Nominate a development candidate within Nurix’s wholly owned degrader pipeline: Nurix is advancing several preclinical programs within its wholly owned pipeline. In 2025, Nurix anticipates nominating at least one development candidate to advance to IND-enabling studies.

On January 12, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported an update on its programs, development plans and guidance on key milestones expected in 2025, to be presented at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California (Filing, Molecular Partners, JAN 12, 2025, View Source [SID1234649710]).

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"We are excited to enter 2025 with upcoming key value inflection points, on the Radio-DARPin side as well as Switch-DARPin and clinical T-cell engagers, to build on our achievements through 2024. Our recently expanded strategic partnership with Orano Med ensures us access to 212Pb, to arm our Radio-DARPins for up to 10 products. MP0712, our most advanced Radio-DARPin targeting DLL3, is moving into clinical development in 2025. Further, we have selected Mesothelin as the second target in the Orano Med partnership, with unique DARPin binders that only bind to juxtamembrane Meso while not being inhibited by the shed target," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Molecular Partners has further strengthened and expanded its agreement with Orano Med for co-development of up to ten 212Pb-based Radio-DARPins. Molecular Partners holds commercialization rights to MP0712, which is the most advanced program, as well as the second nominated Radio-DARPin candidate, which targets the membrane-proximal portion of cell surface glycoprotein Mesothelin (MSLN). Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Further details on this second candidate are scheduled to be unveiled at the Annual Meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Q2 2025.

Patrick Amstutz continued, "We are equally excited that our work on the MP0533 candidate in R/R AML is starting to yield encouraging results. As we work to implement our previously discussed protocol amendments, we are already starting to see patients benefit from treatment in our ongoing cohort 8, where we introduced an additional dosing timepoint early on. These preliminary data provide us with reassurance that our strategy to further densify early dosing has merit and could enable more patients to benefit longer from MP0533."

Cash and Cash Equivalents:
As of Dec 31 2024, Molecular Partners reports cash and cash equivalents of CHF 149 M (unaudited) and will provide full YE financial results on March 6, 2025.

Key current program status updates include:

MP0712 & Radio-DARPin pipeline

The Investigational New Drug (IND) application for MP0712, a 212Pb Radio-DARPin candidate against the tumor-associated protein delta-like ligand 3 (DLL3), is in preparation. Dialogue with the U.S. Food and Drug Administration (FDA) is ongoing and Molecular Partners and Orano Med anticipate submitting the IND application for MP0712 in H1 2025, with the first-in-human study to start following regulatory clearance.

The IND submission is being built, in part, on strong MP0712 preclinical results, including new in vivo data presented at the European Association of Nuclear Medicine Congress in October 2024 and the European Targeted Radiopharmaceuticals Summit in December 2024. MP0712 demonstrated high affinity and specificity for DLL3, which is a highly relevant target for radiopharmaceutical therapy. DLL3 has been shown to have homogeneous expression in tumors of patients with small cell lung cancer, and expression in healthy tissues is low.

The second Radio-DARPin program co-developed with Orano Med targets MSLN, which is overexpressed across several cancers with high unmet need, such as ovarian cancer, and largely absent from healthy tissues. The development of therapeutics against MSLN has been hampered by high shedding of MSLN. Leveraging the unique DARPin properties, Molecular Partners has developed Radio-DARPins able to selectively bind to the membrane-proximal portion of MSLN present on cells and are therefore not impacted by shed MSLN.

In addition to the above updates, Molecular Partners continues to progress its Radio-DARPin Therapy (RDT) portfolio of projects in partnership with Novartis and is evaluating additional targets for RDT programs.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (ClinicalTrials.gov: NCT05673057). Dose escalation in cohort 1–7 showed an acceptable safety profile and initial activity yet unsustained responses (four responders reported and encouraging blast reductions across additional patients), as presented in December 2024 at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting.

In the currently ongoing cohort 8, in which an additional early dosing timepoint was introduced to allow steeper and more frequent dosing to reach the MP0533 target dose faster, increased rates and depth of responses are being observed, with three out of the first eight evaluable patients demonstrating responses to-date (data cutoff 16 December 2024). Molecular Partners has submitted an amendment to the study protocol to improve the exposure profile of MP0533 and to further deepen and expand responses being observed in cohort 8. Data on the amended dosing scheme are expected in 2025.

MP0533 is a novel tetraspecific T cell engaging DARPin which simultaneously targets the three tumor-associated antigens (TAAs) CD33, CD123, and CD70, as well as CD3 on T cells. The mechanism of action of MP0533 is designed to preferentially kill AML cells that express at least two of the three TAAs while sparing healthy cells, which express only one or none of these targets. The immune activation against the malignant cells is achieved through CD3-mediated T cell engagement.

Switch-DARPin Platform (next-generation immune cell engagers)

Preclinical proof-of-concept in a solid tumor model for the novel T cell engager Switch-DARPin was presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November. The presented data provide further validation of Switch-DARPins showing that conditional Tcell activation with potent co-stimulation in solid tumors, but not in healthy tissues, is feasible.

Specifically, the CD3 Switch-DARPin molecule was shown to effectively induce potent tumor regression in vivo. Reduced cytokine release was observed in healthy tissues compared to tumor tissue. Cytokine release syndrome (CRS) is a significant toxicity event that has been observed with many T cell engagers in the clinic. As such, masking CD3 may prevent T cell activation in the absence of tumor antigens and allow for "silent" T cell engagers outside of tumors, thereby reducing the risk of CRS and providing a better safety profile to T cell engagers. In addition, co-engagement of CD2 led to sustained T cell activation and cytotoxic capacity, thereby enabling the development of potent T cell engagers with improved therapeutic window. Molecular Partners plans to present further in vivo data on the CD3 Switch-DARPin at the AACR (Free AACR Whitepaper) Annual Meeting in Q2 2025.

MP0317 (localized agonist)

Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 clinical trial of the CD40 agonist MP0317 in solid tumors at SITC (Free SITC Whitepaper) in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts in the stroma of various solid tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated combination trials of MP0317 in 2025, in combination with immune checkpoint inhibitors and additional standard of care.

J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time: January 15, 2025, at 9:00 AM PST (6:00 PM CET)
Location: Westin St. Francis, Elizabethan A Ballroom, San Francisco, CA

A webcast will be accessible on the Molecular Partners website, under the Events tab.

On January 12, 2025 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, reported plans to highlight the Company’s 2025 strategic initiatives at Biotech Showcase, taking place January 13-15, 2025 in San Francisco during the 43rd Annual JP Morgan Healthcare Conference (Press release, Cellectar Biosciences, JAN 12, 2025, View Source [SID1234649702]). James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 11:30 am Pacific Time.

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Iopofosine I 131 (iopofosine) is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The CLOVER-WaM study (NCT02952508) results demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR. These data were presented as a podium presentation during the 66th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic.

"We remain committed to bringing iopofosine to WM patients, who have limited treatment options for this incurable disease," said James Caruso, president and CEO of Cellectar. "We believe our ongoing communications with the U.S. Food and Drug Administration (FDA) indicate there is a path forward for a conditional U.S. market approval as part of the accelerated approval process. This aligns with our understanding of feedback provided by the European Medicines Agency for conditional EU market authorization, and we are harmonizing recommendations from both agencies for a global approval strategy."

The Company expects the confirmatory study to be a comparator, randomized controlled study with 40-60 patients per arm and full patient enrollment projected within 18 months of the first patient admitted to the study. The Company anticipates alignment with the FDA in the first half of 2025. With a current cash runway extending into the fourth quarter of 2025, the Company is assessing a variety of approaches to bring iopofosine to patients.

Mr. Caruso continued, "We believe iopofosine represents a compelling partnership opportunity for many reasons including the results observed from our clinical studies. The commercial work we conducted in WM provides strong evidence that iopofosine possesses a substantial market opportunity based upon patient outcomes, convenient fixed dosing, off-the-shelf global distribution, and orphan pricing. Cellectar’s goal to bring lifesaving radioconjugates, such as iopofosine, CLR 121225, and CLR 121125, to patients remains steadfast and we look forward to advancing our objectives throughout 2025."

Beyond iopofosine, the Company is focused on the development of its radioconjugate Phospholipid Drug ConjugateTM (PDC) programs, also known as phospholipid radioconjugates or PRCs. CLR 121225 is Cellectar’s lead alpha-emitting actinium-225 radioconjugate PRC. It has demonstrated activity and has been well tolerated in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer. It has also shown excellent biodistribution and uptake into tumors. In animal models of pancreatic adenocarcinoma, the single lowest dose tested provided tumor stasis, and the highest dose provided tumor volume reduction. The Company plans to file an Investigational New Drug (IND) application in the first quarter of 2025.

Cellectar’s lead Auger-emitting (iodine-125) PRC, CLR 121125, has demonstrated tolerability and activity in multiple animal models including triple negative breast cancer. Auger- emitters provide the greatest precision in targeted radiotherapy as the emissions only travel a few nanometers, therefore it is necessary for the isotope to be delivered intracellularly. The Company’s novel PDC platform uniquely provides the required targeted delivery. CLR121125 has received IND clearance and a Phase 1b/2a dose finding study in triple-negative breast cancer is planned.

The Company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125.

Biotech Showcase

A live webcast and a replay of Mr. Caruso’s presentation at Biotech Showcase will be available on the Company’s investor relations website.