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, 2021

☐ 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: 61,101,264 shares of common stock, $0.00001 par value per share, as of November 5, 2021.

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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	25

PART II. OTHER INFORMATION		26

Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 6.	Exhibits	27

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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 (iopofosine, 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, including 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;

●

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.

In some cases, you can identify forward-looking statements by terminology, such as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “believes,” “seeks,” “may,” “should,” “could” 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.

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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. We qualify all of the information presented in this report, and particularly our forward-looking statements, by these cautionary statements.

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	September 30,
	2021		December 31,
	(Unaudited)		2020
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	40,344,727	$	57,165,377
Prepaid expenses and other current assets		1,048,082		774,432
Total current assets		41,392,809		57,939,809
Fixed assets, net		254,041		355,982
Right-of-use asset, net		225,205		282,365
Long-term assets		75,000		75,000
Other assets		6,214		6,214
TOTAL ASSETS	$	41,953,269	$	58,659,370

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued liabilities	$	3,034,489	$	3,443,197
Lease liability		131,406		119,904
Total current liabilities		3,165,895		3,563,101
Long-term lease liability		201,970		301,740
TOTAL LIABILITIES		3,367,865		3,864,841
COMMITMENTS AND CONTINGENCIES (Note 7)
STOCKHOLDERS’ EQUITY:
Preferred stock, $0.00001 par value; 7,000 shares authorized; Series C preferred stock: 0 and 215 issued and outstanding as of September 30, 2021 and December 31, 2020, respectively		—		1,148,204
Series D preferred stock: 111 and 1,519 issued and outstanding as of September 30, 2021 and December 31, 2020, respectively		1,382,023		18,887,645
Common stock, $0.00001 par value; 160,000,000 and 80,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 61,101,264 and 45,442,729 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively		611		454
Additional paid-in capital		182,182,461		161,533,653
Accumulated deficit		(144,979,691)		(126,775,427)
Total stockholders’ equity		38,585,404		54,794,529
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	41,953,269	$	58,659,370

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,
	2021		2020		2021		2020

COSTS AND EXPENSES:
Research and development	$	3,937,464	$	2,683,944	$	13,198,294	$	7,765,673
General and administrative		1,882,190		1,225,993		5,009,581		3,725,153
Total costs and expenses		5,819,654		3,909,937		18,207,875		11,490,826

LOSS FROM OPERATIONS		(5,819,654)		(3,909,937)		(18,207,875)		(11,490,826)

OTHER INCOME:
Interest income, net		590		374		3,611		11,730
Total other income		590		374		3,611		11,730
NET LOSS	$	(5,819,064)	$	(3,909,563)	$	(18,204,264)	$	(11,479,096)
BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE	$	(0.10)	$	(0.15)	$	(0.34)	$	(0.69)
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE		59,868,374		26,326,782		53,633,421		16,539,183

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, 2019	215	$	1,148,204	9,386,689	$	94	$	119,592,366	$	(111,681,255)	$	9,059,409
Stock-based compensation	—		—	—		—		144,146		—		144,146
Vested restricted stock	—		—	9,334		—		—		—		—
Retired shares	—		—	(8)		—		—		—		—
Net loss	—		—	—		—		—		(3,957,608)		(3,957,608)
BALANCE AT MARCH 31, 2020	215	$	1,148,204	9,396,015	$	94	$

SEC Form 10-Q filed by Cellectar Biosciences, Inc.