Cabaletta Bio 第一季業績：現金消耗加劇，研發開支大增，5月融資支撐營運｜10-Q

10-Q
 
 
 
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 

  
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 March 31, 2026
OR
 

 
 
 
 
 

 
 ☐

 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: 001-39103
 
CABALETTA BIO, INC.
(Exact Name of Registrant as Specified in its Charter)
 
 

 
 
 
 
 

 
 Delaware

 82-1685768

 

 
 (State or other jurisdiction of

 (I.R.S. Employer

 

 
 incorporation or organization)

 Identification No.)

 

 
 2929 Arch Street, Suite 600

 19104

 

 
 Philadelphia, PA

  

 

 
 (Address of principal executive offices)

 (Zip Code)

 

 Registrant’s telephone number, including area code: (267) 759-3100
 
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

  

 CABA

  

 The Nasdaq Global Select 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 ☒
As of May 7, 2026, the registrant had 163,054,796 shares of common stock, $0.00001 par value per share, outstanding.
 
 
 

  

 
  

 Table of Contents
 

 
 
 
 
 
 

 
 

 

 Page

 

 
 PART I.

 FINANCIAL INFORMATION

 4

 

 
 Item 1.

 Financial Statements (Unaudited)

 4

 

 
 

 Condensed Consolidated Balance Sheets

 4

 

 
 

 Condensed Consolidated Statements of Operations and Comprehensive Loss 

 5

 

 
 

 Condensed Consolidated Statements of Stockholders’ Equity

 6

 

 
 

 Condensed Consolidated Statements of Cash Flows

 8

 

 
 

 Notes to Unaudited Condensed Consolidated Financial Statements

 9

 

 
 Item 2.

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

 23

 

 
 Item 3.

 Quantitative and Qualitative Disclosures About Market Risk

 35

 

 
 Item 4.

 Controls and Procedures

 35

 

 
 PART II.

 OTHER INFORMATION

 36

 

 
 Item 1.

 Legal Proceedings

 36

 

 
 Item 1A.

 Risk Factors

 36

 

 
 Item 2.

 Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities

 99

 

 
 Item 3.

 Defaults Upon Senior Securities

 99

 

 
 Item 4.

 Mine Safety Disclosures

 99

 

 
 Item 5.

 Other Information

 99

 

 
 Item 6.

 Exhibits

 100

 

 
 Signatures

 101

 

  

 i

 
  

 Summary of the Material and Other Risks Associated with Our Business
•We are a clinical-stage company with a limited operating history, have incurred significant losses since our inception, and anticipate that we will continue to incur significant losses for the foreseeable future.

•We are highly dependent on our relationships with Minaris Advanced Therapies, LLC, or Minaris (f/k/a WuXi Advanced Therapies, Inc) and/or Lonza Houston Inc., or Lonza, and/or Cellares Corporation, or Cellares, for our current manufacturing needs for our Phase 1/2 RESET, or Restoring Self-Tolerance, clinical trials for resecabtagene autoleucel, or rese-cel (formerly referred to as CABA-201), and if manufacturing capacity at any of these manufacturing partners is reduced or otherwise delayed or limited, including due to legislative action, or if we, Minaris, Lonza, Cellares or any third-party manufacturers encounter difficulties in manufacturing our product candidates, this could adversely impact the supply of product candidates for and enrollment in our trials.

•We are reliant on intellectual property licensed to us by Nanjing IASO Biotherapeutics Co., Ltd., or IASO, and termination of this license agreement would result in the loss of significant rights, which would have a material adverse effect on our business.

•If we are unable to obtain and maintain sufficient intellectual property protection for our current product candidates and technologies or any future product candidates, we may not be able to compete effectively in our markets.

•We will need to raise substantial additional funding before we can expect to complete development of any of our product candidates or generate any revenues from product sales.

•Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

•If we are unable to successfully develop our current programs into a portfolio of product candidates, or experience significant delays in doing so, we may not realize the full commercial potential of our current and future product candidates.

•If we encounter difficulties enrolling patients in our RESETTM clinical trials for rese-cel or future clinical trials, these clinical development activities could be delayed or otherwise adversely affected.

•If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

•Results of earlier studies may not be predictive of future study or trial results, and we may fail to establish an adequate safety and efficacy profile to conduct clinical trials or obtain regulatory approval for our product candidates.

•If serious adverse events, undesirable side effects or unexpected characteristics are identified during the development of any of our product candidates, we may need to delay, abandon or limit our further clinical development of those product candidates.

•Manufacturing and administering our product candidates is complex and we may encounter difficulties in technology transfer to a contract manufacturing organization.

•We may be unable to reach agreement with the FDA or comparable foreign regulatory authorities on the methodologies for, and assessment of, comparability of different versions of a product candidate used in non-pivotal studies, pivotal studies and for intended commercial use or may be unable to establish such comparability.

•We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

•We may establish our own manufacturing facility and infrastructure in addition to, or in lieu of, relying on third parties for the manufacture of our product candidates, which will be costly and time-consuming and may not be successful.

•Our future success depends in part upon our ability to retain our key employees, consultants and advisors and to attract, retain and motivate other qualified personnel. 

•We have identified conditions that raise substantial doubt about our ability to continue as a going concern. If we are unable to secure additional funding beyond our current cash position that enables our operations into mid-2027, we may be forced to delay, reduce or discontinue our product development programs efforts or other operations.

 

 1

 
  

 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 
This Quarterly Report on Form 10-Q, including the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains express or implied forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or 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. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
•the success, cost and timing and conduct of our clinical trial programs, including our Phase 1/2 RESETTM clinical trials for rese-cel, and any other product candidates, including statements regarding the timing of initiation, enrollment and completion of the clinical trials and the period during which the results of the clinical trials will become available;

•the expected timing and significance around the announcement of safety, biologic activity and/or any additional clinical data from our RESETTM clinical trials for rese-cel;

•the timing of and our ability to obtain and maintain regulatory approval of our product candidates, including rese-cel, and any other product candidates, in any of the indications for which we plan to develop them, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;

•our expectations for the tolerability and clinical activity of rese-cel and our ability to advance this product candidate through our license agreement with IASO;

•the potential benefits of our Orphan Drug, Rare Pediatric Disease and Fast Track designations;

•our expected use of proceeds from sales of our common stock in "at-the-market" offerings and other offerings, and the period over which such proceeds, together with existing cash, will be sufficient to extend our current cash runway beyond our current expectations into mid-2027 and meet our operating needs, including our ability to continue as a going concern;

•our plans to pursue research and development of other product candidates;

•the potential advantages of our proprietary Cabaletta Approach for B cell Ablation platform, called our CABA® platform, and our product candidates;

•the extent to which our scientific approach and CABA® platform may potentially address a broad range of diseases;

•the potential benefits and success of our arrangements with IASO, Oxford, Minaris, Lonza and Cellares;

•our ability to successfully leverage our research and translational insights;

•our expectations regarding the results observed with the similarly-designed construct employed in recent academic publications, including the dosing regimen, and the implications on rese-cel;

•our ability to successfully commercialize our product candidates, including rese-cel and any other product candidates;

•the potential receipt of revenue from future sales of rese-cel and any other product candidates, if approved;

•the rate and degree of market acceptance and clinical utility of rese-cel and any other product candidates;

•our estimates regarding the potential market opportunity for rese-cel and any other product candidates, and our ability to serve those markets;

•our sales, marketing and distribution capabilities and strategy, whether alone or with potential future collaborators;

•our ability to establish and maintain arrangements or a facility for manufacture of rese-cel and any other product candidates;

•our ability to obtain funding for our operations, including funding necessary to initiate and complete our RESETTM clinical trials of rese-cel and any ongoing preclinical studies of other product candidates;

•our expectations for the efficiency of the trial design for our RESETTM clinical trials for rese-cel and the potential success and therapeutic benefits of rese-cel, including our belief that rese-cel may enable an “immune system reset” and provide deep and durable responses in patients across an increasing number of autoimmune diseases;

•the potential achievement of milestones and receipt of payments under our collaborations;

 2

 
  

 •our ability to enter into additional collaborations with existing collaborators or other third parties;

•our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others;

•our expectations regarding international expansion and the results of our efforts to do so; 

•the success of competing therapies that are or become available, and our competitive position;

•the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

•the impact of government laws and regulations in the United States and foreign countries, including any newly introduced legislation;

•the effect of any geopolitical conflicts or new or increased international tariffs, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to any preclinical studies or research and development efforts, ongoing clinical trials and future clinical trials; and

•our ability to attract and retain key scientific or management personnel.

These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this Quarterly Report on Form 10-Q. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligations to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q.

 3

 
  

 PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
CABALETTA BIO, INC.
Condensed Consolidated Balance Sheets 
(in thousands, except share and per share amounts) 
 
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 March 31,

  

  

 December 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Assets

  

 (unaudited)

  

  

  

  

 

 
 Current assets:

  

  

  

  

  

  

 

 
 Cash and cash equivalents

  

 $

 116,635

  

  

 $

 82,982

  

 

 
 Short-term investments

  

  

 —

  

  

  

 50,617

  

 

 
 Prepaid expenses and other current assets

  

  

 5,681

  

  

  

 5,272

  

 

 
 Total current assets

  

  

 122,316

  

  

  

 138,871

  

 

 
 Property and equipment, net

  

  

 1,585

  

  

  

 1,922

  

 

 
 Finance lease right-of-use assets

  

  

 16,519

  

  

  

 15,700

  

 

 
 Operating lease right-of-use assets

  

  

 2,453

  

  

  

 3,431

  

 

 
 Other assets

  

  

 5,273

  

  

  

 5,159

  

 

 
 Total assets

  

 $

 148,146

  

  

 $

 165,083

  

 

 
 Liabilities and stockholders’ equity

  

  

  

  

  

  

 

 
 Current liabilities:

  

  

  

  

  

  

 

 
 Accounts payable

  

 $

 6,382

  

  

 $

 6,636

  

 

 
 Accrued and other current liabilities

  

  

 12,009

  

  

  

 19,298

  

 

 
 Finance lease liabilities, current portion

  

  

 20,631

  

  

  

 20,758

  

 

 
 Operating lease liabilities, current portion

  

  

 2,485

  

  

  

 3,461

  

 

 
 Total current liabilities

  

  

 41,507

  

  

  

 50,153

  

 

 
 Finance lease liabilities, net of current portion

  

  

 3,334

  

  

  

 2,879

  

 

 
 Total liabilities

  

  

 44,841

  

  

  

 53,032

  

 

 
 Commitments and contingencies (see Notes 5 and 6)

  

  

  

  

  

  

 

 
 Stockholders’ equity:

  

  

  

  

  

  

 

 
    Preferred stock, $0.00001 par value: 10,000,000 shares authorized as of
   March 31, 2026 and December 31, 2025; no shares issued or
   outstanding at March 31, 2026 and December 31, 2025

  

  

 —

  

  

  

 —

  

 

 
   Voting and non-voting common stock, $0.00001 par value: 300,000,000
   (293,590,481 voting and 6,409,519 non-voting) shares 
   authorized as of March 31, 2026 and December 31, 2025; 111,324,796
   voting shares issued and outstanding as of March 31, 2026 and 
   100,479,323 voting shares issued and outstanding as of December 31, 2025

  

  

 1

  

  

  

 1

  

 

 
 Additional paid-in capital

  

  

 663,776

  

  

  

 628,982

  

 

 
 Accumulated other comprehensive income

  

  

 —

  

  

  

 25

  

 

 
 Accumulated deficit

  

  

 (560,472

 )

  

  

 (516,957

 )

 

 
 Total stockholders’ equity

  

  

 103,305

  

  

  

 112,051

  

 

 
 Total liabilities and stockholders’ equity

  

 $

 148,146

  

  

 $

 165,083

  

 

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

 4

 
  

 CABALETTA BIO, INC. 
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts) 
(unaudited) 
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Three Months Ended March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Operating expenses:

  

  

  

  

  

  

 

 
 Research and development

  

 $

 37,353

  

  

 $

 29,018

  

 

 
 General and administrative

  

  

 6,943

  

  

  

 8,118

  

 

 
 Total operating expenses

  

  

 44,296

  

  

  

 37,136

  

 

 
 Loss from operations

  

  

 (44,296

 )

  

  

 (37,136

 )

 

 
 Other income (expense):

  

  

  

  

  

  

 

 
 Interest income

  

  

 1,076

  

  

  

 1,487

  

 

 
 Interest expense

  

  

 (636

 )

  

  

 (294

 )

 

 
 Other income, net

  

  

 341

  

  

  

 —

  

 

 
 Net loss

  

 $

 (43,515

 )

  

 $

 (35,943

 )

 

 
 Other comprehensive income:

  

  

  

  

  

  

 

 
 Net unrealized loss on available-for-sale investments, net of tax

  

  

 (25

 )

  

  

 —

  

 

 
 Net comprehensive loss

  

 $

 (43,540

 )

  

 $

 (35,943

 )

 

 
 Net loss per common stock share, basic and diluted

  

 $

 (0.39

 )

  

 $

 (0.71

 )

 

 
 Weighted-average common shares outstanding, basic and diluted

  

  

 112,025,474

  

  

  

 50,743,101

  

 

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

 5

 
  

 CABALETTA BIO, INC. 
Condensed Consolidated Statements of Stockholders’ Equity 
(in thousands, except share amounts) 
(unaudited) 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

 Common Stock

  

  

  

  

  

  

  

  

  

  

 

 
  

 Shares

  

  

 Amount

  

  

 Additional
Paid-in Capital

  

  

 Accumulated Deficit

  

  

 Total
Stockholders’ Equity

  

 

 
 Balance—December 31, 2024

  

 50,743,101

  

  

 $

 1

  

  

 $

 501,435

  

  

 $

 (349,101

 )

  

 $

 152,335

  

 

 
 Stock-based compensation

  

 —

  

  

  

 —

  

  

  

 5,161

  

  

  

 —

  

  

  

 5,161

  

 

 
 Net loss

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (35,943

 )

  

  

 (35,943

 )

 

 
 Balance—March 31, 2025

  

 50,743,101

  

  

 $

 1

  

  

 $

 506,596

  

  

 $

 (385,044

 )

  

 $

 121,553

  

 

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

 6

 
  

 CABALETTA BIO, INC. 
Condensed Consolidated Statements of Stockholders’ Equity 
(in thousands, except share amounts) 
(unaudited) 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

 Common Stock

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
  

 Shares

  

  

 Amount

  

  

 Additional
Paid-in Capital

  

  

 Accumulated Other Comprehensive Income (Loss)

  

  

 Accumulated Deficit

  

  

 Total
Stockholders’ Equity

  

 

 
 Balance—December 31, 2025

  

 100,479,323

  

  

 $

 1

  

  

 $

 628,982

  

  

 $

 25

  

  

 $

 (516,957

 )

  

 $

 112,051

  

 

 
 Issuance of common stock from ATM offering, net of sales agent commission and fees

  

 8,055,260

  

  

  

 —

  

  

  

 22,568

  

  

  

 —

  

  

  

 —

  

  

  

 22,568

  

 

 
 Issuance of common stock upon exercise of common stock warrants

  

 2,775,100

  

  

  

 —

  

  

  

 6,938

  

  

  

 —

  

  

  

 —

  

  

  

 6,938

  

 

 
 Issuance of common stock in connection with exercise of stock options

  

 15,113

  

  

  

 —

  

  

  

 32

  

  

  

 —

  

  

  

 —

  

  

  

 32

  

 

 
 Stock-based compensation

  

 —

  

  

  

 —

  

  

  

 5,256

  

  

  

 —

  

  

  

 —

  

  

  

 5,256

  

 

 
 Net unrealized losses on available-for-sale securities

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (25

 )

  

  

 —

  

  

  

 (25

 )

 

 
 Net loss

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 —

  

  

  

 (43,515

 )

  

  

 (43,515

 )

 

 
 Balance—March 31, 2026

  

 111,324,796

  

  

 $

 1

  

  

 $

 663,776

  

  

 $

 —

  

  

 $

 (560,472

 )

  

 $

 103,305

  

 

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

 7

 
  

 CABALETTA BIO, INC. 
Condensed Consolidated Statements of Cash Flows 
(in thousands) 
(unaudited) 
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Three Months Ended March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Cash flows from operating activities:

  

  

  

  

  

  

 

 
 Net loss

  

 $

 (43,515

 )

  

 $

 (35,943

 )

 

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

  

  

  

  

  

  

 

 
 Stock-based compensation

  

  

 5,256

  

  

  

 5,161

  

 

 
 Depreciation

  

  

 337

  

  

  

 485

  

 

 
 Non-cash finance lease expense

  

  

 4,022

  

  

  

 1,465

  

 

 
 Non-cash operating lease expense

  

  

 978

  

  

  

 881

  

 

 
 Accretion of operating lease liabilities

  

  

 81

  

  

  

 167

  

 

 
 Amortization of discount on investments

  

  

 (368

 )

  

  

 —

  

 

 
 Loss on foreign currency exchange rates

  

  

 19

  

  

  

 29

  

 

 
 Changes in operating assets and liabilities:

  

  

  

  

  

  

 

 
 Prepaid expenses and other current assets

  

  

 (409

 )

  

  

 (53

 )

 

 
 Other assets

  

  

 (114

 )

  

  

 (76

 )

 

 
 Accounts payable

  

  

 (269

 )

  

  

 1,591

  

 

 
 Accrued and other current liabilities

  

  

 (7,281

 )

  

  

 (3,538

 )

 

 
 Lease liabilities

  

  

 (1,057

 )

  

  

 (1,057

 )

 

 
 Accrued interest payable under finance lease

  

  

 (241

 )

  

  

 86

  

 

 
 Net cash used in operating activities

  

  

 (42,561

 )

  

  

 (30,802

 )

 

 
 Cash flows from investing activities:

  

  

  

  

  

  

 

 
 Purchases of property and equipment

  

  

 —

  

  

  

 (785

 )

 

 
 Proceeds from maturities of investments

  

  

 50,960

  

  

  

 —

  

 

 
 Net cash provided by (used in) investing activities

  

  

 50,960

  

  

  

 (785

 )

 

 
 Cash flows from financing activities:

  

  

  

  

  

  

 

 
 Issuance of common stock from ATM offering, net of sales agent commission and fees

  

  

 22,568

  

  

  

 —

  

 

 
 Proceeds from issuance of common stock upon exercise of common stock warrants

  

  

 6,938

  

  

  

 —

  

 

 
 Proceeds from issuance of common stock in connection with the
exercise of stock options

  

  

 32

  

  

  

 —

  

 

 
 Principal payments on finance leases

  

  

 (4,271

 )

  

  

 (552

 )

 

 
 Net cash provided by (used in) financing activities

  

  

 25,267

  

  

  

 (552

 )

 

 
 Effect of exchange rate changes on cash and cash equivalents

  

  

 (13

 )

  

  

 7

  

 

 
 Net increase (decrease) in cash and cash equivalents

  

  

 33,653

  

  

  

 (32,132

 )

 

 
 Cash and cash equivalents—beginning of period

  

  

 82,982

  

  

  

 163,962

  

 

 
 Cash and cash equivalents—end of period

  

 $

 116,635

  

  

 $

 131,830

  

 

 
 Supplemental disclosures

  

  

  

  

  

  

 

 
 Cash paid for interest

  

 $

 877

  

  

 $

 208

  

 

 
 Right-of-use assets obtained in exchange for finance lease obligations

  

 $

 4,841

  

  

 $

 14,930

  

 

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

 8

 
  

 CABALETTA BIO, INC. 
Notes to the Unaudited Condensed Consolidated Financial Statements 
(in thousands, except share and per share amounts) 
1. Basis of Presentation 
Cabaletta Bio, Inc. (the Company or Cabaletta) was incorporated in April 2017 in the State of Delaware as Tycho Therapeutics, Inc. and, in August 2018, changed its name to Cabaletta Bio, Inc. The unaudited condensed consolidated financial statements include the accounts of Cabaletta and its wholly owned subsidiaries: Cabaletta Bio GmbH and Cabaletta Bio (Germany) GmbH.
The Company is headquartered in Philadelphia, Pennsylvania. Cabaletta is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for autoimmune diseases. Principal operations commenced in April 2018.
Risks and Uncertainties
The Company does not expect to generate revenue from sales of engineered T cell therapies for autoimmune diseases or any other revenue unless and until the Company completes preclinical and clinical development and obtains regulatory approval for one or more product candidates. If the Company seeks to obtain regulatory approval for any of its product candidates, the Company expects to incur significant commercialization expenses.
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. As a result, the Company is unable to predict the timing or amount of increased expenses or when or if the Company will be able to achieve or maintain profitability. Further, the Company is dependent on third parties for certain research and development activities, including manufacturing services (Note 5 and Note 6). Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. Even if the Company is able to generate revenues from the sale of its product candidates, if approved, it may not become profitable. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then it may be unable to continue its operations at planned levels and be forced to reduce its operations.
Liquidity and Going Concern
In accordance with Accounting Standards Codification (ASC) 205-40, Going Concern, (ASC 205-40) the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern. The Company has sustained annual operating losses since inception and expects to continue to generate operating losses for the foreseeable future. As of March 31, 2026, the Company has incurred an accumulated deficit of $560,472 and has cash and cash equivalents of $116,635. In May 2026, the Company raised aggregate net proceeds of approximately $141,000 (Note 9).
 The Company expects that its current cash and cash equivalents may be sufficient to fund operations for at least the next twelve months from the date of issuance of these unaudited condensed consolidated financial statements; however, the Company's cash forecast contains estimates and assumptions with significant variability and management cannot predict the amount or timing of all expenditures with certainty. The Company’s ultimate success depends on the outcome of its research and development activities. Management expects to incur additional losses in the future as it continues its research and development and will need to raise additional capital to fully implement its business plan and to fund its operations. The Company intends to raise such additional capital through a combination of equity offerings, debt financings, government funding arrangements, strategic alliances or other sources. However, if such financing is not available at adequate levels and on a timely basis, or such agreements are not available on favorable terms, or at all, as and when needed, the Company will need to reevaluate its operating plan and may be required to delay or discontinue the development of one or more of its product candidates or operational initiatives. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business.

 9

 
  

 2. Summary of Significant Accounting Policies 
Unaudited Interim Financial Information
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles (GAAP) and the applicable rules and regulations of the SEC regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB). As permitted under these rules, certain footnotes and other financial information that are normally required by GAAP have been condensed or omitted. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals and estimates that impact the financial statements) considered necessary to present fairly the Company’s financial position as of March 31, 2026 and the results of its operations and its cash flows for the interim periods ended March 31, 2026 and 2025. The results for the three months ended March 31, 2026 are not necessarily indicative of results to be expected for the year ending December 31, 2026, any other interim periods, or any future year or period. The balance sheet as of December 31, 2025 included herein was derived from the audited financial statements as of that date. The unaudited condensed consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements, which are included in the Company’s 2025 Annual Report on Form 10-K, filed with the SEC on March 23, 2026 (2025 Annual Report).

Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include but are not limited to advance payments and accruals related to the Company’s research and development expenses. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates.

Off-Balance Sheet Risk and Concentrations of Credit Risk
Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist of cash and cash equivalents, which are invested in U.S. treasury-based money market funds, and available-for-sale debt securities, which are invested in U.S. treasury securities. A portion of the Company’s cash is maintained at federally insured financial institutions, and account balances may at times exceed federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk. The Company has no off‑balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. 
The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts and U.S. treasury securities.

Significant Accounting Policies
There have been no significant changes to the Company’s accounting policies during the three months ended March 31, 2026, as compared to the significant accounting policies described in Note 2 of the “Notes to the Financial Statements” in the Company’s audited financial statements included in its 2025 Annual Report.

Fair Value Measurement
Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must 

 10

 
  

 maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: 
Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. 
Level 2—Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. 
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.

Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Reporting Comprehensive Income-Expense Disaggregation Disclosures. ASU 2024-03 requires enhanced disclosures about components of expense captions on the face of the income statement. This standard will be effective for fiscal years beginning after December 15, 2026. Early adoption is permitted. ASU 2024-03 applies on a prospective basis for periods beginning after the effective date. However, retrospective application to any or all prior periods presented is permitted. The Company is currently planning to adopt this guidance when effective and is assessing the impact of the adoption on the Company’s consolidated financial statements and accompanying footnotes.

 11

 
  

 3. Fair Value Measurements 
Fair value of financial instruments
At March 31, 2026 and December 31, 2025, the Company’s financial instruments included cash and cash equivalents, available-for-sale debt securities, accounts payable and accrued expenses. The carrying amounts for cash and cash equivalents, accounts payable and accrued expenses reported in the Company’s consolidated financial statements for these instruments approximate their respective fair values because of the short-term nature of these instruments.
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values:

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 March 31, 2026

  

 

 
  

  

 Total

  

  

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

  

  

 Significant
Other
Observable
Inputs
(Level 2)

  

  

 Significant
Unobservable
Inputs
(Level 3)

  

 

 
 Financial assets

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Cash equivalents:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Money market funds

  

 $

 114,506

  

  

 $

 114,506

  

  

 $

 —

  

  

 $

 —

  

 

 
 Total

  

 $

 114,506

  

  

 $

 114,506

  

  

 $

 —

  

  

 $

 —

  

 

  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 December 31, 2025

  

 

 
  

  

 Total

  

  

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

  

  

 Significant
Other
Observable
Inputs
(Level 2)

  

  

 Significant
Unobservable
Inputs
(Level 3)

  

 

 
 Financial assets

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Cash equivalents:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Money market funds

  

 $

 81,470

  

  

 $

 81,470

  

  

 $

 —

  

  

 $

 —

  

 

 
 Short-term investments:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 U.S. Treasury securities

  

  

 50,617

  

  

  

 —

  

  

  

 50,617

  

  

  

 —

  

 

 
 Total

  

 $

 132,087

  

  

 $

 81,470

  

  

 $

 50,617

  

  

 $

 —

  

 

 
 
Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1 inputs. Investments are measured at fair value based on inputs other than quoted prices that are derived from observable market data and are classified as Level 2 inputs.
For debt securities classified as available-for-sale investments, the Company records unrealized gains or losses resulting from changes in fair value between measurement dates as a component of other comprehensive income. The Company did not hold any available-for-sale securities as of March 31, 2026.
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 December 31, 2025

  

 

 
  

  

 Amortized Cost

  

  

 Gross Unrealized Gains

  

  

 Fair value

  

 

 
 Financial assets

  

  

  

  

  

  

  

  

  

 

 
 Cash

  

 $

 1,512

  

  

 $

 —

  

  

 $

 1,512

  

 

 
 Money market funds

  

  

 81,470

  

  

  

 —

  

  

  

 81,470

  

 

 
 Included in cash and cash equivalents

  

  

 82,982

  

  

  

 —

  

  

  

 82,982

  

 

 
 U.S. Treasury securities - due in one year or less

  

  

  

  

  

  

  

  

  

 

 
 Included in sho