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Cellectar Biosciences Announces Tranche A Warrants Fully Exercised, Providing Proceeds of $44.1 Million

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Cellectar Biosciences, Inc. (NASDAQ: CLRB) announced the full exercise of Tranche A warrants from a previous private placement, resulting in gross proceeds of approximately $44.1 million. Additionally, the company issued Tranche B warrants for potential aggregate proceeds of approximately $34.3 million. The Tranche B warrants contain a trigger for investors to exercise following the Company's public announcement of its receipt of written approval from the U.S. FDA of its New Drug Application (NDA) for iopofosine I 131, or September 8, 2028. The president and CEO, James Caruso, expressed confidence in the company's lead asset, iopofosine I 131, and highlighted the strengthened balance sheet and investor support for achieving near-term milestones, including NDA submission and potential accelerated FDA approval.
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The full exercise of Tranche A warrants by investors, generating gross proceeds of approximately $44.1 million for Cellectar Biosciences, indicates a robust vote of confidence from the market in the company's potential, particularly in its lead asset, iopofosine I 131. This capital infusion is significant as it strengthens the company's balance sheet, providing the necessary funds to continue its clinical development programs and prepare for a potential market launch. The financial support also underlines the company's capability to meet near-term milestones, which is a critical factor for investors assessing the risk and growth prospects of a biopharmaceutical firm.

From a financial perspective, the exercise of warrants is a non-dilutive financing option that can be favorable for existing shareholders as it avoids the immediate issuance of new shares, which could otherwise lead to share price dilution. However, it is essential to monitor the company's burn rate and the potential exercise of Tranche B warrants, which could result in additional capital but also further dilution down the line.

The successful development and potential FDA approval of iopofosine I 131 for Waldenstrom’s macroglobulinemia and other cancers with significant unmet clinical needs could represent a substantial advancement in oncology therapeutics. The focus on rare and hard-to-treat cancers positions Cellectar to potentially capture a niche market with limited competition. However, the clinical and commercial success of such drugs hinges on efficacy and safety profiles that must meet or exceed current treatment standards.

It is also crucial to consider the regulatory environment, as an accelerated FDA approval can significantly reduce the time to market, providing patients with earlier access to new therapies and allowing the company to generate revenue sooner. However, this process often requires ongoing post-marketing studies to confirm the drug's clinical benefits, which entails further investment and risk.

Understanding the market dynamics for rare cancer treatments is essential. The potential approval of iopofosine I 131 could disrupt the current treatment landscape for Waldenstrom’s macroglobulinemia and other targeted indications. Market analysts would evaluate the size of the patient population, the competitive landscape, pricing strategy and reimbursement factors that are all pivotal for the successful commercialization of a new drug.

Investor sentiment, as reflected in the full exercise of the Tranche A warrants, can be indicative of market expectations for the drug's success. However, the actual market uptake post-launch will be the true test of the drug's commercial viability. It is important to assess how Cellectar plans to navigate market access challenges, including payer negotiations and patient outreach, to secure a successful product launch.

FLORHAM PARK, N.J., Jan. 25, 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 Tranche A warrants issued as part of the private placement announced in September 2023 have been exercised in full. All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.

In connection with the September 2023 private placement, Cellectar also issued to investors five-year Tranche B warrants for potential aggregate proceeds of approximately $34.3 million. The Tranche B warrants contain a 10-trading-day trigger for investors to exercise following the earlier of the Company’s public announcement of its receipt of written approval from the U.S. FDA of its New Drug Application (NDA) for iopofosine I 131, or September 8, 2028.

“We believe that the exercise of 100 percent of the available Tranche A warrants is a testament to the confidence our investors have in our company and lead asset, iopofosine I 131,” said James Caruso, president and CEO of Cellectar. “The strengthened balance sheet and investor financial support allows us to remain focused on the required execution to achieve the planned near-term milestones, including the NDA submission, potential accelerated FDA approval and thoughtful preparations for the launch of iopofosine in Waldenstrom’s macroglobulinemia. In parallel, we continue our clinical development of iopofosine in cancers with significant unmet clinical needs, such as multiple myeloma, pediatric high-grade gliomas, CNS lymphoma and others.”

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.

The company’s product pipeline includes lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

For more information, please visit and www.wmclinicaltrial.com or join the conversation by liking and following us on the company’s social media channels: TwitterLinkedIn, and Facebook.

Forward-Looking Statement Disclaimer

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes, including our expectations regarding the WM CLOVER WaM pivotal trial and NDA approval. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2022, and our Form 10-Q for the quarter ended September 30, 2023. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

Contacts

MEDIA:
Claire LaCagnina
Bliss Bio Health
315-765-1462
clacagnina@blissbiohealth.com

INVESTORS:
Chad Kolean
Chief Financial Officer
investors@cellectar.com


FAQ

What is the ticker symbol for Cellectar Biosciences, Inc.?

The ticker symbol for Cellectar Biosciences, Inc. is CLRB.

What was the gross proceeds from the exercise of Tranche A warrants?

The exercise of Tranche A warrants resulted in gross proceeds of approximately $44.1 million.

What are the potential aggregate proceeds from the Tranche B warrants?

The Tranche B warrants have potential aggregate proceeds of approximately $34.3 million.

What is the trigger for investors to exercise the Tranche B warrants?

The trigger for investors to exercise the Tranche B warrants is the Company's public announcement of its receipt of written approval from the U.S. FDA of its New Drug Application (NDA) for iopofosine I 131, or September 8, 2028.

What are the near-term milestones mentioned by the CEO?

The near-term milestones include NDA submission, potential accelerated FDA approval, and preparations for the launch of iopofosine in Waldenstrom’s macroglobulinemia, as well as clinical development in other cancers with unmet clinical needs.

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About CLRB

cellectar biosciences is developing phospholipid drug conjugates (pdcs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. cellectar's pdc platform is based on the company's proprietary phospholipid ether analogs. these novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. cellectar's pdc pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. the company's lead therapeutic pdc, clr 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. clr 131 has been designated as an orphan drug by the us fda and is currently being evaluated in a phase 1 clinical study in patients with relapsed or refractory multiple myeloma and a phase 2 clinical study to assess efficacy in a range of b-cell malignancies. the company is also developing proprietary pdcs for targeted delivery of chemotherapeutics and has several preclinical stage p