U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

[mark one]

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: September 30, 2022

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______________ to ______________

Commission File Number 1-36598

CELLECTAR BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)


DELAWARE	04-3321804
(State or other jurisdiction of	(IRS Employer
incorporation or organization)	Identification No.)

100 Campus Drive

Florham Park, New Jersey 07932

(Address of principal executive offices, including zip code)

(608) 441-8120

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

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		CLRB		NASDAQ Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐	Non-accelerated filer	☒	Smaller reporting company	☒	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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Number of shares outstanding of the issuer’s common stock as of the latest practicable date: 9,385,272 shares of common stock, $0.00001 par value per share, as of October 31, 2022.

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CELLECTAR BIOSCIENCES, INC.

FORM 10-Q INDEX


	Forward-Looking Statements	3

PART I. FINANCIAL INFORMATION		5

Item 1.	Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 4.	Controls and Procedures	27

PART II. OTHER INFORMATION		28

Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 6.	Exhibits	29

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FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q of Cellectar Biosciences, Inc. (the “Company”, “Cellectar”, “we”, “us”, “our”) contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act. Examples of our forward-looking statements include:

●

our current views with respect to our business strategy, business plan and research and development activities;

●

the future impacts of the COVID-19 pandemic on our business, employees, operating results, ability to recruit patients for clinical studies, ability to obtain additional funding, product development programs, research and development programs, suppliers and third-party manufacturers;

●

the progress of our product development programs, including clinical testing and the timing of commencement and results thereof;

●

our projected operating results, including research and development expenses;

●

our ability to continue development plans for iopofosine I 131 (also known as CLR 131), CLR 1900 series, CLR 2000 series and CLR 12120;

●

our ability to continue development plans for our Phospholipid Drug Conjugates (PDC)™;

●

our ability to maintain orphan drug designation in the U.S. for iopofosine as a therapeutic for the treatment of multiple myeloma, neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing’s sarcoma and lymphoplasmacytic lymphoma, and the expected benefits of orphan drug status;

●

any disruptions at our sole supplier of iopofosine;

●

our ability to pursue strategic alternatives;

●

our ability to advance our technologies into product candidates;

●

our enhancement and consumption of current resources along with ability to obtain additional funding;

●

our current view regarding general economic and market conditions, including our competitive strengths;

●

uncertainty and economic instability resulting from conflicts, military actions, terrorist attacks, natural disasters, public health crises, including the occurrence of a contagious disease or illness such as the COVID-19 pandemic, cyber-attacks and general instability;

●

the future impacts of legislative and regulatory developments in the United States on the pricing and reimbursement of our product candidates;

●

our ability to meet the continued listing standards of Nasdaq;

●

assumptions underlying any of the foregoing; and

●

any other statements that address events or developments that we intend or believe will or may occur in the future.

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In some cases, you can identify forward-looking statements by terminology, such as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “believes,” “seeks,” “may,” “should,” “could”, “would” or the negative of such terms or other similar expressions. Accordingly, these statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Forward-looking statements also involve risks and uncertainties, many of which are beyond our control. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this quarterly report.

You should read this report completely and with the understanding that our actual future results may be materially different from what we expect. You should assume that the information appearing in this report is accurate as of the date hereof only. Because the risk factors referred to herein could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

This quarterly report on Form 10-Q contains trademarks and service marks of Cellectar Biosciences, Inc. Unless otherwise provided in this quarterly report on Form 10-Q, trademarks identified by ™ are trademarks of Cellectar Biosciences, Inc. All other trademarks are the property of their respective owners.

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)


	September 30,		December 31,
	2022		2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	17,785,322	$	35,703,975
Prepaid expenses and other current assets		975,936		867,485
Total current assets		18,761,258		36,571,460
Fixed assets, net		338,944		344,491
Right-of-use asset, net		138,097		204,644
Long-term and other assets		81,214		81,214
TOTAL ASSETS	$	19,319,513	$	37,201,809

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	$	6,367,035	$	3,854,914
Lease liability		148,200		135,449
Total current liabilities		6,515,235		3,990,363
Long-term lease liability, net of current portion		53,769		166,292
TOTAL LIABILITIES		6,569,004		4,156,655
COMMITMENTS AND CONTINGENCIES (Note 7)
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.00001 par value; 7,000 shares authorized; Series D preferred stock: 111 shares issued and outstanding		1,382,023		1,382,023
Common stock, $0.00001 par value; 160,000,000 shares authorized; 6,110,119 and 6,110,125 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively		61		61
Additional paid-in capital		183,652,376		182,560,859
Accumulated deficit		(172,283,951)		(150,897,789)
Total stockholders’ equity		12,750,509		33,045,154
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	19,319,513	$	37,201,809

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

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CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
COSTS AND EXPENSES:
Research and development	$	5,380,190	$	3,937,464	$	13,765,846	$	13,198,294
General and administrative		2,435,296		1,882,190		7,625,391		5,009,581
Total costs and expenses		7,815,486		5,819,654		21,391,237		18,207,875

LOSS FROM OPERATIONS		(7,815,486)		(5,819,654)		(21,391,237)		(18,207,875)

OTHER INCOME:
Interest income, net		4,164		590		5,075		3,611
Total other income		4,164		590		5,075		3,611
NET LOSS	$	(7,811,322)	$	(5,819,064)	$	(21,386,162)	$	(18,204,264)
BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE	$	(1.28)	$	(0.97)	$	(3.50)	$	(3.39)
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE		6,110,119		5,986,837		6,110,123		5,363,342

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

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CELLECTAR BIOSCIENCES, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)


											Total
	Preferred Stock			Common Stock			Additional		Accumulated		Stockholders’
	Shares	Amount		Shares	Par Amount		Paid‑In Capital		Deficit		Equity
BALANCE AT DECEMBER 31, 2020	1,734	$	20,035,849	4,544,272	$	45	$	161,534,062	$	(126,775,427)	$	54,794,529
Stock-based compensation	—		—	—		—		124,564		—		124,564
Conversion of preferred shares for common shares	(789)		(8,288,652)	627,823		6		8,288,646		—		—
Exercise of warrants for common shares	—		—	100,532		1		1,213,923		—		1,213,924
Net loss	—		—	—		—		—		(6,357,170)		(6,357,170)
BALANCE AT MARCH 31, 2021	945	$	11,747,197	5,272,627	$	52	$	171,161,195	$	(133,132,597)	$	49,775,847
Stock-based compensation	—		—	—		—		200,617		—		200,617
Conversion of preferred shares for common shares	(250)		(3,109,552)	250,000		3		3,109,549		—		—
Issuance of common stock, net of issuance costs	—		—	4,169		—		34,873		—		34,873
Retired shares	—		—	(3)		—		—		—		—
Net loss	—		—	—		—		—		(6,028,030)		(6,028,030)
BALANCE AT JUNE 30, 2021	695	$	8,637,645	5,526,793	$	55	$	174,506,234	$	(139,160,627)	$	43,983,307
Stock-based compensation	—		—	—		—		421,161		—		421,161
Conversion of preferred shares for common shares	(584)		(7,255,622)	583,333		6		7,255,616		—		—
Net loss	—		—	—		—		—		(5,819,064)		(5,819,064)
BALANCE AT SEPTEMBER 30, 2021	111	$	1,382,023	6,110,126	$	61	$	182,183,011	$	(144,979,691)	$	38,585,404
BALANCE AT DECEMBER 31, 2021	111	$	1,382,023	6,110,126	$	61	$	182,560,859	$	(150,897,789)	$	33,045,154
Stock-based compensation	—		—	—		—		303,805		—		303,805
Retired shares	—		—	(1)		—		—		—		—
Net loss	—		—	—		—		—		(6,139,797)		(6,139,797)
BALANCE AT MARCH 31, 2022	111	$	1,382,023	6,110,125	$	61	$	182,864,664	$	(157,037,586)	$	27,209,162
Stock-based compensation	—		—	—		—		419,953		—		419,953
Retired shares	—		—	(2)		—		—		—		—
Net loss	—		—	—		—		—		(7,435,043)		(7,435,043)
BALANCE AT JUNE 30, 2022	111	$	1,382,023	6,110,123	$	61	$	183,284,617	$	(164,472,629)	$	20,194,072
Stock-based compensation	—		—	—		—		367,759		—		367,759
Retired shares	—		—	(4)		—		—		—		—
Net loss	—		—	—		—		—		(7,811,322)		(7,811,322)
BALANCE AT SEPTEMBER 30, 2022	111	$	1,382,023	6,110,119	$

SEC Form 10-Q filed by Cellectar Biosciences Inc.