clbs-20220930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q


☒			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 001-33650

LISATA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware			22-2343568
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

110 Allen Road, 2nd Floor, Basking Ridge, New Jersey			07920
(Address of principal executive offices)			(zip code)

Registrant’s telephone number, including area code: 908-842-0100

Caladrius Biosciences, Inc.

(Former name or former address, 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 $0.001 per share	LSTA	The 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 and post such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition 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 ☒

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.


Class	Outstanding as of November 10, 2022
Common stock, $0.001 par value per share	7,859,684	shares

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report (this “Quarterly Report”) contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as well as historical information. When used in this Quarterly Report, statements that are not statements of current or historical fact may be deemed to be forward-looking statements, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. Without limiting the foregoing, the words “plan,” “project,” “forecast,” “outlook,” “intend,” “may,” “will,” “expect,” “anticipate,” “likely,” “believe,” “could,” “anticipate,” “estimate,” “continue,” “target” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity or our achievements or industry results, to be materially different from any future results, performance, levels of activity or our achievements or industry results expressed or implied by such forward-looking statements. Factors that could cause our actual results to differ materially from anticipated results expressed or implied by forward-looking statements include, among others:

•our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates, and the commercialization of the relevant technology;

•our ability to build and maintain the management and human resources infrastructure necessary to support the growth of our business;

•whether a relevant market is established for our products and services and our ability to capture a meaningful share of this market;

•scientific, regulatory and medical developments beyond our control;

•our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or to comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business;

•whether any of our current or future patent applications result in issued patents, the scope of those patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business, and our ability to commercialize products without infringing upon the claims of third-party patents;

•whether any potential strategic or financial benefits of various licensing agreements will be realized;

•the long-term success of our recently completed merger with Cend Therapeutics, Inc. (“Cend”), including the ongoing integration of Cend’s operations and the advancement of their development programs;

•the results of our development activities;

•our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population, competition with other clinical trials for similar subjects and the need of patients to meet the inclusion criteria of the trial or otherwise;

•the extent to which the COVID-19 pandemic and/or its long-term effects may impact, directly or indirectly, our business, including our clinical trials and financial condition;

•our ability to maintain the listing of our common stock on The Nasdaq Capital Market; and

•other factors discussed in “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 22, 2022 (our “2021 Form 10-K”), in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2022 and June 30, 2022 and in Exhibit 99.2 to our Amendment No. 1 to Current Report on Form 8-K/A filed on October 4, 2022.

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The factors discussed herein, including those risks described in “Item 1A. Risk Factors” and elsewhere in our 2021 Form 10-K and in our other periodic filings with the SEC, which are available for review at www.sec.gov, could cause actual results and developments to be materially different from those expressed or implied by such statements. All forward-looking statements attributable to us are expressly qualified in their entirety by these and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. Except as required by law, we undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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TABLE OF CONTENTS


	PART I- FINANCIAL INFORMATION	Page No.
Item 1.	Financial Statements:	5
	Consolidated Balance Sheets at September 30, 2022 (unaudited) and December 31, 2021	5
	Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021 (unaudited)	6
	Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2022 and 2021 (unaudited)	7
	Consolidated Statements of Equity for the three and nine months ended September 30, 2022 and 2021 (unaudited)	8
	Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021 (unaudited)	10
	Notes to Unaudited Consolidated Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	26
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	35
Item 4.	Controls and Procedures	35
	PART II- OTHER INFORMATION
Item 1.	Legal Proceedings	37
Item 1A.	Risk Factors	37
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	37
Item 3.	Defaults Upon Senior Securities	37
Item 4.	Mine Safety Disclosures	37
Item 5.	Other Information	37
Item 6.	Exhibits	37
	Signatures	38

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PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

LISATA THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)


	September 30, 2022		December 31, 2021
ASSETS	(Unaudited)
Cash and cash equivalents	$	31,478	$	24,647
Marketable securities	44,052		70,323
Prepaid and other current assets	1,760		1,212
Total current assets	77,290		96,182
Property and equipment, net	299		62
Acquired license - intangible	352		—
Other assets	588		764
Total assets	$	78,529	$	97,008

LIABILITIES AND STOCKHOLDERS' EQUITY
Liabilities
Accounts payable	$	974	$	1,934
Accrued liabilities	5,417		2,589
Total current liabilities	6,391		4,523
Other long-term liabilities	367		485
Total liabilities	6,758		5,008
Commitments and Contingencies (Note 13)

Stockholders' Equity
Preferred stock, authorized, 20,000,000 shares Series B convertible redeemable preferred stock liquidation value, 0.000067 share of common stock, $0.01 par value; 825,000 shares designated; issued and outstanding, 10,000 shares at September 30, 2022 and December 31, 2021, respectively	—		—
Common stock, $0.001 par value, authorized 33,333,333 shares; issued 7,863,340 and 3,986,719 shares at September 30, 2022 and December 31, 2021, respectively; and outstanding, 7,862,602 and 3,985,981 shares at September 30, 2022 and December 31, 2021, respectively	8		4
Additional paid-in capital	574,066		546,044
Treasury stock, at cost; 738 shares at September 30, 2022 and December 31, 2021	(708)		(708)
Accumulated deficit	(501,251)		(453,016)
Accumulated other comprehensive loss	(90)		(70)
Total Lisata Therapeutics, Inc. stockholders' equity	72,025		92,254
Non-controlling interests	(254)		(254)
Total stockholders' equity	71,771		92,000
Total liabilities, non-controlling interests and stockholders' equity	$	78,529	$	97,008

See accompanying notes to consolidated financial statements.

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LISATA THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Operating Expenses:
Research and development	$	3,380	$	4,125	$	9,898	$	13,530
In-process research and development	30,393		—		30,393		—
General and administrative	3,947		2,843		10,770		8,671
Total operating expenses	37,720		6,968		51,061		22,201

Operating loss	(37,720)		(6,968)		(51,061)		(22,201)

Other income (expense):
Investment income, net	337		41		496		111
Other expense, net	—		—		(149)		(90)
Total other income (expense)	337		41		347		21

Net loss before benefit from income taxes and noncontrolling interests	(37,383)		(6,927)		(50,714)		(22,180)
Benefit from income taxes	—		—		(2,479)		(1,508)


Net loss attributable to Lisata Therapeutics, Inc. common stockholders	$	(37,383)	$	(6,927)	$	(48,235)	$	(20,672)


Basic and diluted loss per share
Lisata Therapeutics, Inc. common stockholders	$	(7.88)	$	(1.74)	$	(11.28)	$	(5.76)

Weighted average common shares outstanding
Basic and diluted shares	4,747		3,974		4,276		3,587

See accompanying notes to consolidated financial statements.

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LISATA THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(In thousands)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net loss	$	(37,383)	$	(6,927)	$	(48,235)	$	(20,672)

Other comprehensive loss:
Available for sale securities - net unrealized gain (loss)	5		(47)		5		(51)
Cumulative translation adjustment arising during the period	(25)		—		(25)		—
Total other comprehensive loss	(20)		(47)		(20)		(51)





Comprehensive loss attributable to Lisata Therapeutics, Inc. common stockholders	$	(37,403)	$	(6,974)	$	(48,255)	$	(20,723)

See accompanying notes to consolidated financial statements.

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LISATA THERAPEUTICS, INC. AND SUBSIDIARIES

SEC Form 10-Q filed by Caladrius Biosciences Inc.