10-Q
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UNITED STATES

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, 2023

OR

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

 

Commission File Number: 001-33038

 

Alaunos Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

84-1475642

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

8030 El Rio Street

Houston, TX 77054

(346) 355-4099

(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)

 

 

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

 

TCRT

 

The Nasdaq Stock Market LLC

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 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

As of November 9, 2023, the number of outstanding shares of the registrant's common stock, $0.001 par value, was 240,627,055 shares.

 

 

 

 


SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are all statements contained in this Quarterly Report that are not historical fact, and in some cases can be identified by terms such as: “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “target,” “will” and other words and terms of similar meaning.

These statements are based on management’s current beliefs and assumptions and on information currently available to management. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that the expectations reflected in such forward-looking statements are reasonable, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:

our ability to successfully implement our strategic reprioritization or realize any or all of the anticipated benefits once implemented;
our ability to raise substantial additional capital to continue as a going concern and fund our planned operations in the near term and our strategic reprioritization in the longer term;
our ability to successfully consummate any strategic transactions, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions;
estimates regarding our expenses, use of cash, timing of future cash needs and anticipated capital requirements;
our ability to license additional intellectual property to support our strategic reprioritization or out-license our intellectual property and to comply with our existing license agreements;
our ability to enter into partnerships or strategic collaboration agreements and our ability to achieve the results and potential benefits contemplated from relationships with collaborators;
our ability to maintain collaborations and licenses;
our expectation of developments and projections relating to competition from other pharmaceutical and biotechnology companies or our industry;
the anticipated amount, timing and accounting of contract liabilities, milestones and other payments under licensing, collaboration or acquisition agreements, research and development costs and other expenses;
our ability to remain listed on the Nasdaq Capital Market; and
our intellectual property position, including the strength and enforceability of our intellectual property rights.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

Unless the context requires otherwise, references in this Quarterly Report to “Alaunos,” the “Company,” “we,” “us” or “our” refer to Alaunos Therapeutics, Inc.

We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. We own the trademarks Alaunos®, Ziopharm® and hunTR® as well as the graphic trademark found on our website. Other trademarks, service marks and trade names appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to in this Quarterly Report are listed without the ® and ™ symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names.

 

i


SUMMARY OF SELECTED RISKS ASSOCIATED WITH OUR BUSINESS

 

Our business faces significant risks and uncertainties. If any of the following risks are realized, our business, financial condition and results of operations could be materially and adversely affected. You should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report. Some of the more significant risks include the following:

Our strategic reprioritization may not be successful, may not yield the desired results and we may be unsuccessful in identifying and implementing any strategic transaction.
Even if we successfully consummate a transaction from our strategic assessment, we may fail to realize all of the anticipated benefits of the transaction, those benefits may take longer to realize than expected, or we may encounter integration difficulties.
If a strategic transaction is not consummated, our Board of Directors may decide to pursue a dissolution and liquidation. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.
We may require substantial additional financial resources to continue as a going concern, including through the strategic review process, and if we raise additional funds it may affect the value of your investment in our common stock.
Our ability to consummate a strategic transaction depends on our ability to retain our remaining employees.
We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.
We have halted development of our product candidates very early in our development efforts. Our most advanced product candidates were only in an early-stage clinical trial, which is very expensive and time-consuming. We cannot be certain if or when we will be able to submit a Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or the FDA, and the delay, or any failure, in completing clinical trials for our product candidates could harm our business.
If we or our licensors fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish and our ability to successfully commercialize our products may be impaired.
Our stock price has been, and may continue to be, volatile.
We received a Delisting Determination from Nasdaq. Delisting could prevent us from maintaining an active, liquid and orderly trading market for our common stock and may impact our ability to consummate certain strategic transactions.
We may effect a reverse stock split of our common stock, but it may not result in us obtaining the intended benefits.
Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult.

ii


Table of Contents

 

 

 

Page

 

 

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

Item 1.

Condensed Financial Statements (unaudited)

2

 

Condensed Balance Sheets as of September 30, 2023 (unaudited) and December 31, 2022

2

 

Condensed Statements of Operations for the three and nine months ended September 30, 2023 and 2022 (unaudited)

3

 

Condensed Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2023 and 2022 (unaudited)

4

 

Condensed Statements of Cash Flows for the nine months ended September 30, 2023 and 2022 (unaudited)

6

 

Notes to Condensed Financial Statements (unaudited)

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

19

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

27

Item 4.

Controls and Procedures

27

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

28

Item 1A.

Risk Factors

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

55

Item 3.

Defaults Upon Senior Securities

55

Item 4.

Mine Safety Disclosures

55

Item 5.

Other Information

55

Item 6.

Exhibits

57

 

1


PART I—FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

Alaunos Therapeutics, Inc.

CONDENSED BALANCE SHEETS

(unaudited)

(in thousands, except share and per share data)

 

 

September 30,

 

 

December 31,

 

 

2023

 

 

2022

 

ASSETS:

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

11,944

 

 

$

39,058

 

Restricted cash

 

 

 

 

 

13,938

 

Receivables

 

 

 

 

 

4

 

Prepaid expenses and other current assets

 

 

925

 

 

 

799

 

Total current assets

 

 

12,869

 

 

 

53,799

 

Property and equipment, net

 

 

5,532

 

 

 

8,460

 

Right-of-use assets

 

 

1,039

 

 

 

2,136

 

Deposits

 

 

 

 

 

42

 

Other non-current assets

 

 

 

 

 

500

 

Total assets

 

$

19,440

 

 

$

64,937

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,298

 

 

$

1,389

 

Current portion of long-term debt

 

 

 

 

 

16,765

 

Accrued expenses

 

 

3,071

 

 

 

5,454

 

Lease liabilities, current

 

 

307

 

 

 

558

 

Total current liabilities

 

 

4,676

 

 

 

24,166

 

Lease liabilities, non-current

 

 

864

 

 

 

2,188

 

Other non-current liabilities

 

 

 

 

 

28

 

Total liabilities

 

$

5,540

 

 

$

26,382

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

Common stock $0.001 par value; 520,000,000 shares authorized, 240,627,055 shares issued and outstanding at September 30, 2023 and 420,000,000 shares authorized, 240,410,761 shares issued and outstanding at December 31, 2022

 

 

241

 

 

 

240

 

Additional paid-in capital

 

 

921,583

 

 

 

918,942

 

Accumulated deficit

 

 

(907,924

)

 

 

(880,627

)

Total stockholders' equity

 

 

13,900

 

 

 

38,555

 

Total liabilities and stockholders' equity

 

$

19,440

 

 

$

64,937

 

 

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

2


Alaunos Therapeutics, Inc.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share data)

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration Revenue

 

$

 

 

$

2,911

 

 

$

4

 

 

$

2,911

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,656

 

 

 

7,893

 

 

 

15,346

 

 

 

19,411

 

General and administrative

 

 

3,578

 

 

 

3,282

 

 

 

9,791

 

 

 

10,217

 

Gain on lease modification

 

 

 

 

 

 

 

 

(245

)

 

 

(133

)

Restructuring costs

 

 

419

 

 

 

 

 

 

419

 

 

 

 

Property and equipment and right-of-use asset impairment

 

 

1,011

 

 

 

 

 

 

1,011

 

 

 

 

Total operating expenses

 

 

8,664

 

 

 

11,175

 

 

 

26,322

 

 

 

29,495

 

Loss from operations

 

 

(8,664

)

 

 

(8,264

)

 

 

(26,318

)

 

 

(26,584

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 

 

 

(841

)

 

 

(1,921

)

 

 

(2,266

)

Other income, net

 

 

188

 

 

 

254

 

 

 

942

 

 

 

279

 

Other income (expense), net

 

 

188

 

 

 

(587

)

 

 

(979

)

 

 

(1,987

)

Net loss

 

$

(8,476

)

 

$

(8,851

)

 

$

(27,297

)

 

$

(28,571

)

Basic and diluted net loss per share

 

$

(0.04

)

 

$

(0.04

)

 

$

(0.11

)

 

$

(0.13

)

Weighted average common shares outstanding, basic and diluted

 

 

240,046,026

 

 

 

215,098,995

 

 

 

239,842,327

 

 

 

215,015,377

 

 

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

 

 

3


Alaunos Therapeutics, Inc.

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands, except share and per share data)

 

For the Three Months Ended September 30, 2023

 

Common Stock

 

 

Additional Paid in Capital

 

 

Accumulated Deficit

 

 

Total Stockholders' Equity

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2023

 

 

240,627,055

 

 

$

241

 

 

$

920,857

 

 

$

(899,448

)

 

 

21,650

 

Stock-based compensation

 

 

 

 

 

 

 

 

726

 

 

 

 

 

 

726

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,476

)

 

 

(8,476

)

Balance at September 30, 2023

 

 

240,627,055

 

 

$

241

 

 

$

921,583

 

 

$

(907,924

)

 

$

13,900

 

 

 

 

For the Nine Months Ended September 30, 2023

 

 

Common Stock

 

 

Additional Paid in Capital

 

 

Accumulated Deficit

 

 

Total Stockholders' Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2022

 

 

240,410,761

 

 

$

240

 

 

$

918,942

 

 

$

(880,627

)

 

$

38,555

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,550

 

 

 

 

 

 

2,550

 

Issuance of common stock, net of expenses

 

 

216,294

 

 

 

1

 

 

 

91

 

 

 

 

 

 

92

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(27,297

)

 

 

(27,297

)

Balance at September 30, 2023

 

 

240,627,055

 

 

$

241

 

 

$

921,583

 

 

$

(907,924

)

 

$

13,900

 

 

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

 

4


 

For the Three Months Ended September 30, 2022

 

 

Common Stock

 

 

Additional Paid in Capital

 

 

Accumulated Deficit

 

 

Total Stockholders' Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2022

 

 

216,174,542

 

 

$

216

 

 

$

902,536

 

 

$

(862,572

)

 

$

40,180

 

Stock-based compensation

 

 

 

 

 

 

 

 

808

 

 

 

 

 

 

808

 

Exercise of employee stock options

 

 

26,250

 

 

 

 

 

 

21

 

 

 

 

 

 

21

 

Repurchase of common stock

 

 

(18,750

)

 

 

 

 

 

 

 

 

(45

)

 

 

(45

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,851

)

 

 

(8,851

)

Balance at September 30, 2022

 

 

216,182,042

 

 

$

216

 

 

$

903,365

 

 

$

(871,468

)

 

$

32,113

 

 

 

 

For the Nine Months Ended September 30, 2022

 

 

Common Stock

 

 

Additional Paid in Capital

 

 

Accumulated Deficit

 

 

Total Stockholders' Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2021

 

 

216,127,443

 

 

$

216

 

 

$

900,693

 

 

$

(842,852

)

 

$

58,057

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,651

 

 

 

 

 

 

2,651

 

Restricted stock awards

 

 

280,000

 

 

 

 

 

 

 

 

 

 

 

 

 

Cancelled restricted common stock

 

 

(232,901

)

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of employee stock options

 

 

26,250

 

 

 

 

 

 

21

 

 

 

 

 

 

21

 

Repurchase of common stock

 

 

(18,750

)

 

 

 

 

 

 

 

 

(45

)

 

 

(45

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(28,571

)

 

 

(28,571

)

Balance at September 30, 2022

 

 

216,182,042

 

 

$

216

 

 

$

903,365

 

 

$

(871,468

)

 

$

32,113

 

 

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

5


Alaunos Therapeutics, Inc.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

For the Nine Months Ended September 30,

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(27,297

)

 

$

(28,571

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

2,074

 

 

 

2,065

 

Property and equipment right-of-use asset impairment

 

 

1,011

 

 

 

 

Amortization of financing costs

 

 

1,339

 

 

 

634

 

Stock-based compensation

 

 

2,550

 

 

 

2,651

 

Decrease in the carrying amount of right-of-use assets

 

 

1,332

 

 

 

2,306

 

Gain on lease modification

 

 

(245

)

 

 

(133

)

Loss on disposal of equipment

 

 

12

 

 

 

 

(Increase) decrease in:

 

 

 

 

 

 

Receivables

 

 

4

 

 

 

(1,800

)

Prepaid expenses and other current assets

 

 

(126

)

 

 

817

 

Deposits

 

 

42

 

 

 

 

Other non-current assets

 

 

500

 

 

 

131

 

Increase (decrease) in:

 

 

 

 

 

 

Accounts payable

 

 

(92

)

 

 

616

 

Accrued expenses

 

 

(2,258

)

 

 

1,525

 

Lease liabilities

 

 

(1,575

)

 

 

(2,371

)

Other non-current liabilities

 

 

(28

)

 

 

28

 

Net cash used in operating activities

 

 

(22,757

)

 

 

(22,102

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(197

)

 

 

(100

)

Proceeds from the disposal of property and equipment

 

 

40

 

 

 

 

Net cash used in investing activities

 

 

(157

)

 

 

(100

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from the issuance of common stock

 

 

92

 

 

 

 

Proceeds from the exercise of stock options

 

 

 

 

 

21

 

Repurchase of common stock

 

 

 

 

 

(45

)

Repayment of long-term debt

 

 

(18,105

)

 

 

(2,083

)

Debt extinguishment costs

 

 

(125

)

 

 

 

Net cash used in financing activities

 

 

(18,138

)

 

 

(2,107

)

Net decrease in cash, cash equivalents and restricted cash

 

 

(41,052

)

 

 

(24,309

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

52,996

 

 

 

76,054

 

Cash and cash equivalents, end of period

 

$

11,944

 

 

$

51,745

 

Supplementary disclosure of cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

2,063

 

 

$

1,603

 

Amounts included in accounts payable and accrued expenses related to property and equipment

 

$

1

 

 

$

348

 

 

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

 

 

6


Alaunos Therapeutics, Inc.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

1.
Organization

Overview

Alaunos Therapeutics, Inc., which is referred to herein as “Alaunos,” or the “Company,” is a clinical-stage oncology-focused cell therapy company that was historically involved in the development of adoptive TCR therapies, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. On January 25, 2022, the Company changed its corporate name from ZIOPHARM Oncology, Inc. to Alaunos Therapeutics, Inc. The Company is leveraging its proprietary, non-viral Sleeping Beauty gene transfer platform and its novel cancer mutation hotspot TCR library to design and manufacture personalized cell therapies that target neoantigens arising from common tumor-related mutations in key oncogenic genes, including KRAS, TP53 and EGFR.

The Company’s operations to date have consisted primarily of conducting research and development and raising capital to fund those efforts.

On August 14, 2023, the Company announced a strategic reprioritization of its business and wind down of its TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, the Company has reduced its workforce by approximately 80% to date and continues working to reduce costs in order to extend its cash runway. The Company continues to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. The Company has engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process.

As of September 30, 2023, there were 240,627,055 shares of common stock outstanding and an additional 35,339,371 shares of common stock reserved for issuance pursuant to outstanding stock options and warrants.

The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company follows the guidance of Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements - Going Concern, in order to determine whether there is substantial doubt about its ability to continue as a going concern for one year after the date its condensed financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the condensed financial statements are issued. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the condensed financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the condensed financial statements are issued.

The Company has operated at a loss since its inception in 2003 and has no recurring revenue from operations. The Company anticipates that losses will continue for the foreseeable future. As of September 30, 2023, the Company had approximately $11.9 million of cash and cash equivalents. The Company’s accumulated deficit at September 30, 2023 was approximately $907.9 million. Given its current development plans and cash management efforts, the Company anticipates cash resources will be sufficient to fund operations into the second quarter of 2024. The Company’s ability to continue operations after its current cash resources are exhausted depends on future events outside of the Company's control, including its ability to obtain additional financing or to achieve profitable results, as to which no assurances can be given. If adequate additional funds are not available when required, or if the Company is unsuccessful in entering into partnership agreements for further development of its product candidates, management may need to curtail its development efforts and planned operations to conserve cash until sufficient additional capital is raised. There can be no assurances that such a plan would be successful.

Based on the current cash forecast and the Company's dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, management has determined that the Company's present capital resources will not be sufficient to fund its planned operations for at least one year from the issuance date of the condensed financial statements, and substantial doubt as to the Company's ability to continue as a going concern exists. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of expenses could vary materially and adversely as a result of a number of factors.

Basis of Presentation

The accompanying unaudited interim condensed financial statements have been prepared in accordance with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. Certain information and note

7


Alaunos Therapeutics, Inc.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

disclosures required by generally accepted accounting principles in the United States, or GAAP, have been condensed or omitted pursuant to such rules and regulations.

It is management’s opinion that the accompanying unaudited interim condensed financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. The unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the SEC on March 7, 2023, or the Annual Report.

The results disclosed in the statements of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the full fiscal year 2023.

Use of Estimates

The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period. Although the Company regularly assesses these estimates, actual results could differ from those estimates. Changes in estimates are recorded in the period in which they become known.

Our accrued expenses represent estimates of activity and costs incurred with vendors and counterparties. During the three and nine months ended September 30, 2023, the Company revised estimated accrued expenses related to de-prioritized clinical programs based on new information received from vendors. As a result, a $0.3 million credit has been recorded in research and development expense within the condensed statement of operations for the three months ended September 30, 2023, and a $1.0 million credit has been recorded for the nine months ended September 30, 2023.

2.
Financings

2021 Loan and Security Agreement

On August 6, 2021, the Company entered into a Loan and Security Agreement, or the Loan and Security Agreement, with Silicon Valley Bank and affiliates of Silicon Valley Bank, or collectively, SVB. The Loan and Security Agreement provided for an initial term loan of $25.0 million funded at the closing, or the Term A Tranche, with an additional tranche of $25.0 million available if certain funding and clinical milestones were met by August 31, 2022, or the Term B Tranche.

Effective December 28, 2021, the Company, entered into an amendment to the Loan and Security Agreement, or the First Amendment. The First Amendment extended the interest-only period through August 31, 2022. The First Amendment also eliminated the Term B Tranche, which remained unfunded, leaving only the Term A Tranche, or the SVB Facility. Under the amended Loan and Security Agreement, the SVB Facility was to mature on August 1, 2023. On May 1, 2023, the Company repaid its outstanding debt obligations under the amended Loan and Security Agreement in their entirety.

Refer to Note 4, Debt, for further discussion of the Loan and Security Agreement and the First Amendment.

2022 Equity Distribution Agreement

On August 12, 2022, the Company entered into an Equity Distribution Agreement, or the Equity Distribution Agreement, with Piper Sandler & Co., or Piper Sandler, pursuant to which the Company can offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through Piper Sandler as its sales agent in an "at the market offering." Piper Sandler will receive a commission of 3.0% of the gross proceeds of any common stock sold under the Equity

8


Alaunos Therapeutics, Inc.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Distribution Agreement. During the three and nine months ended September 30, 2023, there have been no sales of the Company's common stock under the Equity Distribution Agreement.

2022 Public Offering

On November 29, 2022, the Company entered into an underwriting agreement, or the Underwriting Agreement, with Cantor as the sole underwriter, relating to the issuance and sale in an underwritten offering, or the Offering, of 24,228,719 shares, or the Firm Shares, of the Company’s common stock to Cantor at a price of $0.6191 per share.

The net proceeds to the Company from the Offering were $14.7 million (before accounting for the partial exercise of Cantor's option as described below) after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Under the terms of the Underwriting Agreement, the Company granted Cantor an option, exercisable for 30 days, to purchase up to an additional 3,634,307 shares of common stock, which we refer to, together with the Firm Shares, as the Shares, at the same price per share as the Firm Shares. On January 5, 2023, Cantor partially exercised its option to purchase an additional 216,294 shares of common stock.

3.
Summary of Significant Accounting Policies

 

The Company’s significant accounting policies were identified in the Company’s Annual Report. There have been no material changes in those policies since the filing of its Annual Report.

4.
Debt

The carrying values of the Company's debt obligation were as follows:

 

 

September 30,

 

 

December 31,

 

($ in thousands)

 

2023

 

 

2022

 

Loan and Security Agreement

 

$

 

 

$

17,395

 

Unamortized discount on Loan and Security Agreement

 

 

 

 

 

(630

)

Total debt

 

$

 

 

$

16,765

 

 

On August 6, 2021, the Company entered into the Loan and Security Agreement with SVB. The Loan and Security Agreement provided for the funding of the Term A Tranche at the closing, with the Term B Tranche available if certain funding and clinical milestones were met by August 31, 2022. The SVB Facility and related obligations under the Loan and Security Agreement were secured by substantially all of the Company's properties, rights and assets, except for its intellectual property (which was subject to a negative pledge under the Loan and Security Agreement). In addition, the Loan and Security Agreement contained customary representations, warranties, events of default and covenants.

On December 28, 2021, the Company entered into the First Amendment to the Loan and Security Agreement. The First Amendment eliminated the unfunded Term B Tranche, among other things. The SVB Facility bore interest at a floating rate per annum on outstanding loans, payable monthly, at the greater of (a) 7.75% and (b) the current published U.S. prime rate, plus a margin of 4.5%.

All outstanding obligations under the amended Loan and Security Agreement were due and payable on August 1, 2023. In connection with the payment of all of the Company's outstanding obligations, the Company also owed SVB 5.75% of the original principal amounts borrowed as a final payment, or the Final Payment. Effective March 30, 2023, the Company entered into a Third Amendment to the Loan and Security Agreement, or the Third Amendment. Under the terms of the Third Amendment, the Company was no longer required to maintain all of its operating accounts, depository accounts and excess cash with SVB or one of its affiliates, and was instead only required to maintain a single operating or depository account at Silicon Valley Bank. The Third Amendment also modified the cash collateralization requirement, such that the Company was required to cash collateralize the entire sum of the outstanding principal amount of the SVB Facility, plus an amount equal to the Final Payment, which amount was to be reduced commensurate with each regularly scheduled monthly payment of principal and interest on the SVB Facility.

On May 1, 2023, the Company paid SVB an amount equal to the entire outstanding principal amount under the SVB Facility, all accrued and unpaid interest and the Final Payment. In accordance with the First Amendment, the payment was subject to a prepayment premium of 2.00%. During the second quarter of 2023, the Company recorded the remaining amounts associated with the Final Payment of $0.5 million and the prepayment premium of $0.1 million as interest expense within the condensed statement of operations.

9


Alaunos Therapeutics, Inc.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

In connection with its entry into the Loan and Security Agreement in August 2021, the Company issued to SVB warrants to purchase (i) up to 432,844 shares of the Company’s common stock, in the aggregate, and (ii) up to an additional 432,842 shares of common stock, in the aggregate, in the event the Company achieved certain clinical milestones, in each case at an exercise price per share of $2.22.

In connection with its entry into the First Amendment in December 2021, the Company amended and restated the warrants issued to SVB. As amended and restated, the warrants are for up to 649,615 shares of the Company's common stock, in the aggregate, with an exercise price of $1.16 per share, or the SVB Warrants. The SVB Warrants expire on August 6, 2031.

The issuance costs for the Loan and Security Agreement, including the First Amendment, were approximately $1.2 million and primarily related to the issuance of the SVB Warrants, which were amortized into interest expense over the term of the loan. Interest expense, including the amortization of issuance costs, was $0 for the three months ended September 30, 2023 and was $1.9 million for the nine months ended September 30, 2023, compared to $0.8 million for the three months ended September 30, 2022 and $2.3 million for the nine months ended September 30, 2022.

5.
Fair Value Measurements

Fair Value of Financial Instruments

The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements.

Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Assets and liabilities measured at fair value on a recurring and nonrecurring basis as of September 30, 2023 and December 31, 2022 are as follows:

 

($ in thousands)

 

 

 

 

Fair Value Measurements at Reporting Date Using

 

Description

 

Balance as of
September 30,
2023

 

 

Quoted Prices in
Active Markets
for Identical
Assets/Liabilities
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Cash equivalents

 

$

11,681

 

 

$

11,681

 

 

$

 

 

$

 

 

($ in thousands)

 

 

 

 

Fair Value Measurements at Reporting Date Using

 

Description

 

Balance as of
December 31,
2022

 

 

Quoted Prices in
Active Markets
for Identical
Assets/Liabilities
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Cash equivalents

 

$

38,058

 

 

$

38,058

 

 

$

 

 

$

 

 

The cash equivalents represent demand deposit accounts and deposits in a short-term United States treasury money market mutual fund quoted in an active market and classified as a Level 1 asset.

 

There have been no changes to the valuation methods during the three or nine months ended September 30, 2023. We had no financial assets or liabilities that were classified as Level 2 or Level 3 during the three or nine months ended September 30, 2023.

Fair Value of Non-Financial Instruments

The Company evaluates assets for impairment whenever events or changes in circumstances indicate that indicators of impairment exist. In those evaluations, the Company compares estimated future undiscounted cash flows generated by each asset (or asset group) to the carrying value of the asset (or asset group) to determine if an impairment charge is required. If the undiscounted cash flows test fails, the Company estimates the fair value of the asset (or asset group) to determine the impairment.

10


Alaunos Therapeutics, Inc.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Following the Company’s announced strategic reprioritization on August 14, 2023, the Company determined that changes in the intended use of certain property and equipment represented an indicator of impairment, resulting in an impairment charge of $1.0 million, which was primarily related to lab equipment of $0.9 million and leasehold improvements of $0.1 million.

In addition, the Company determined certain prepaid expense balances to be impaired given the Company’s strategic reprioritization, and therefore, has recorded an impairment charge of $0.1 million related to prepaid expenses and other current assets, which is recorded in research and development expenses within the condensed statement of operations.

On November 9, 2023, the Company executed an agreement to sell laboratory equipment for gross proceeds of $1.5 million. As of September 30, 2023, the laboratory equipment had a carrying value of $1.5 million recorded within Property and Equipment, net in the condensed balance sheet.

6.
Net loss per share

Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per share is computed using the weighted-average number of shares of common stock outstanding during the period, plus the dilutive effect of outstanding options and warrants, using the treasury stock method and the average market price of the Company's common stock during the applicable period, unless their effect on net loss per share is antidilutive. The effect of computing diluted net loss per common share was antidilutive for any potentially issuable shares of common stock from the conversion of stock options, unvested restricted stock and warrants and, as such, have been excluded from the calculation. Such potentially dilutive shares of common stock consisted of the following as of September 30, 2023 and 2022:

 

 

September 30,

 

 

2023

 

 

2022

 

Common stock options

 

 

12,417,029

 

 

 

10,623,215

 

Unvested restricted stock

 

 

437,500

 

 

 

940,000

 

Warrants

 

 

22,922,342

 

 

 

22,922,342

 

 

 

35,776,871

 

 

 

34,485,557

 

 

7.
Related Party Transactions

Joint Venture with TriArm Therapeutics/Eden BioCell

On December 18, 2018, the Company and TriArm Therapeutics, Ltd., or TriArm, launched Eden BioCell, Ltd., or Eden BioCell, as a joint venture to lead commercialization of the Company’s Sleeping Beauty-generated CAR-T therapies in the People’s Republic of China (including Macau and Hong Kong), Taiwan and Korea. The Company licensed to Eden BioCell the rights in Greater China for its third-generation Sleeping Beauty-generated CAR-T therapies targeting the CD19 antigen. Eden BioCell is owned equally by the Company and TriArm and the parties share decision-making authority. TriArm contributed $10.0 million to Eden BioCell and has committed up to an additional $25.0 million to this joint venture. TriArm also managed all clinical development in the territory pursuant to a master services agreement between TriArm and Eden BioCell. James Huang was the founder and serves as managing partner of Panacea Venture, which is an investor in TriArm. Mr. Huang was the Chair of the Company's board of directors until September 22, 2023 and had been a director since July 2020. He also serves as a member of Eden BioCell’s board of directors.

In September 2021, TriArm and Alaunos mutually agreed to dissolve the Eden BioCell joint venture. The joint venture agreement has been terminated and the Eden BioCell entity has been dissolved as of July 2023. Refer to Note 13, Joint Venture, for further details.

8.
Leases

In April 2022, the Company modified its real estate lease agreement executed on December 15, 2020 with MD Anderson for office space in Houston, Texas, which reduced the Company's leased space from 18,111 square feet to 3,228 square feet. As a result, the associated lease liability and right-of-use asset were remeasured to $0.4 million based on revised lease payments. A gain of $0.1 million was recorded on the lease modification during the second quarter of 2022.

On April 19, 2023, the Company terminated its office lease in Boston, Massachusetts, which was set to expire on August 31, 2026. In connection with the termination, the Company also assigned to the landlord its sub-sublease of the Boston office space, which had a term expiring on June 30, 2025 with an option to extend through July 31, 2026. Termination costs for the Boston office lease were $0.2 million. A gain of $0.2 million was recorded on the lease termination during the second quarter of 2023.

11


Alaunos Therapeutics, Inc.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

In August 2023, in accordance with the lease agreement executed on December 15, 2020, the Company notified MD Anderson, as landlord, of its intention to terminate office space of 3,228 square feet in Houston, Texas. As a result, the associated lease liability and right-of-use asset were remeasured to $19 thousand, reflecting the revised lease payments and term end date of November 2023.

On November 1, 2023, the Company and MD Anderson, as landlord, agreed to mutually terminate the leases dated October 15, 2019 and April 7, 2020, which represent office space totaling 14,037 square feet. The termination will be effective November 15, 2023 and the Company has agreed to make a final payment of $0.1 million to the landlord.

9.
Commitments and Contingencies

License Agreements