CLRB Cellectar Biosciences Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): May 14, 2024

 

 

Cellectar Biosciences, Inc.

(Exact name of Registrant as Specified in its Charter)

 

 

Delaware		1-36598		04-3321804
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

100 Campus Drive, Florham Park, NJ, 07932

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (608) 441-8120

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.00001 per share		CLRB		The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

Item 2.02.

Results of Operations and Financial Condition.

 

On May 14, 2024, we issued a press release announcing our financial results for the quarter ended March 31, 2024 and provided a corporate update. A copy of the press release is furnished as Exhibit 99.1 and is incorporated by reference herein.

 

Item 9.01.

Financial Statements and Exhibits

 

(d) Exhibits

 

Number		Title
99.1		Press release dated May 14, 2024, titled “Cellectar Biosciences Reports Financial Results for Q1 2024 and Provides a Corporate Update”
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	CELLECTAR BIOSCIENCES, INC.
Date: May 14, 2024	By:	/s/ Chad J. Kolean
	Name:	Chad J. Kolean
	Title:	Chief Financial Officer

 

 

Exhibit 99.1

 

Cellectar Biosciences Reports Financial Results for Q1 2024 and Provides a Corporate Update

 

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 – 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 evaluating iopofosine I 131 in Waldenstrom’s macroglobulinemia in June and are on track to submit our NDA in the second half of 2024. We remain pleased with patient enrollment in the phase 1b pediatric high-grade glioma study and expect to announce data in the second half of 2024,” said James Caruso, president, and CEO of Cellectar. “Either alone or in collaboration, we continue to assess the versatility of our delivery platform with a wide range of cancer targeting compounds including peptides, oligos and our alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225, which is planned to enter a phase 1 study in either triple negative breast or pancreatic cancer no later than first quarter 2025.”

 

First Quarter and Recent Corporate Highlights

 

·

Announced positive topline data achieving its primary endpoint in its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potentially first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients with a median of four prior lines of therapy. The CLOVER WaM study met its primary endpoint with a major response rate of 61%. The overall response rate was 75.6%. The Company plans to announce data for all evaluable patients in June 2024.

 

·

Reported a complete remission rate of 64% and overall response rate of 73% in highly refractory patients in an investigator-initiated Phase I study of iopofosine in combination with External Beam Radiotherapy in recurrent head and neck cancer. In addition to the high rate of complete remission, durability of clinical activity achieved a 67% overall survival and 42% progression free survival at one year.

 

·

Reported the complete central nervous system clearance in a relapsed/refractory Waldenstrom’s macroglobulinemia patient, providing further validation for iopofosine I 131 to treat solid and hematologic tumors, including those located across the blood-brain barrier.

 

 

·

Enrolled the first patient in the company’s Phase 1b clinical study of iopofosine I 131 in pediatric high-grade gliomas (pHGG). The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data.

 

·

Announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225 (225Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound expands the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs).

 

·

Announced strategic partnerships with leading community-based oncology networks Florida Cancer Specialists and American Oncology Network (AON) to advance the treatment of WM in the community setting.

 

First Quarter 2024 Financial Highlights

 

·

Cash and Cash Equivalents: As of March 31, 2024, the company had cash and cash equivalents of $40.0 million, compared to $9.6 million as of December 31, 2023. Net cash used in operating activities during the three months ended March 31, 2024, was approximately $13 million. The company believes its cash balance as of March 31, 2024, is adequate to fund its basic budgeted operations into the fourth quarter of 2024.

 

·

Research and Development Expense: R&D expense for the three months ended March 31, 2024, was approximately $7.4 million, compared to approximately $6.7 million for the three months ended March 31, 2023. The overall increase in R&D expense was primarily a result of increased manufacturing and related costs related to the development of supply chain and production sourcing enhancements, partially offset by a decrease in general research and development costs.

 

·

General and Administrative Expense: G&A expense for the three months ended March 31, 2024, was $4.6 million, compared to $2.1 million for the same period in 2023. The increase in G&A costs was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel costs.

 

·

Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2024, was ($21.6) million, or $(0.74) per share, compared to $(8.6) million, or ($0.76) per share in the three months ended March 31, 2023.

 

Conference Call & Webcast Details

 

Cellectar management will host a conference call for investors today, May 14, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. The call will be available via webcast by clicking HERE or on the Events page of the company’s website after the conclusion of the call.

 

 

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 www.cellectar.com and www.wmclinicaltrial.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, 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 CLOVER WaM pivotal trial. 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, 2023, and our Form 10-Q for the quarter ended March 31, 2024. 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

 

 

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

		March 31,				December 31,
		2024				2023
ASSETS
CURRENT ASSETS:
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
CURRENT LIABILITIES:
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
COMMITMENTS AND CONTINGENCIES (Note 7)
STOCKHOLDERS’ EQUITY:
Series D preferred stock, 111.11 shares authorized, issued and outstanding as of March 31, 2024 and December 31, 2023			1,382,023				1,382,023
Series E-2 preferred stock, 1,225.00 shares authorized; 237.50 and 319.76 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively			3,474,286				4,677,632
Series E-3 preferred stock, 2,205.00 shares authorized; 630.00 and 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively			12,222,000				—
Common stock, $0.00001 par value; 170,000,000 shares authorized; 33,164,466 and 20,744,110 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively			332				207
Additional paid-in capital			248,151,681				210,066,630
Accumulated deficit			(239,064,176	)			(217,482,539	)
Total stockholders’ equity			26,166,146				(1,356,047	)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	42,908,439			$	12,075,580

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

		Three Months Ended March 31,
		2024				2023
COSTS AND EXPENSES:
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	)
OTHER (LOSS) INCOME:
Loss on valuation of warrants			(9,900,000	)			—
Interest income, net			319,849				124,034
Total other (loss) income, net			(9,580,151	)			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 ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE			29,346,679				11,261,217

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

v3.24.1.1.u2

Cover	May 14, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	May 14, 2024
Entity File Number	1-36598
Entity Registrant Name	Cellectar Biosciences, Inc.
Entity Central Index Key	0001279704
Entity Tax Identification Number	04-3321804
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	100 Campus Drive
Entity Address, City or Town	Florham Park
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07932
City Area Code	608
Local Phone Number	441-8120
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.00001 per share
Trading Symbol	CLRB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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