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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 September 30, 2021

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: (267759-3100

 

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 October 29, 2021, the registrant had 28,331,638 shares of common stock, $0.00001 par value per share, outstanding.

 

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

3

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Balance Sheets

3

 

Condensed Statements of Operations and Comprehensive Loss

4

 

Condensed Statements of Stockholders’ Equity

5

 

Condensed Statements of Cash Flows

7

 

Notes to Unaudited Condensed Financial Statements

8

Item 2.

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

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

29

Item 4.

Controls and Procedures

29

PART II.

OTHER INFORMATION

30

Item 1.

Legal Proceedings

30

Item 1A.

Risk Factors

30

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

91

Item 3.

Defaults Upon Senior Securities

91

Item 4.

Mine Safety Disclosures

91

Item 5.

Other Information

91

Item 6.

Exhibits

92

Signatures

93

 

 

 

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 relationship with University of Pennsylvania, or Penn, for our preclinical research and development activities, key technology and our current manufacturing needs for our clinical trial of DSG3-CAART, or the DesCAARTesTM trial, and if Penn’s manufacturing capacity is reduced or otherwise delayed or limited, this could adversely impact enrollment in our DesCAARTesTM trial.

 

We are reliant on intellectual property licensed to us by Penn and termination of our license agreement with Penn 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 DSG3-CAART, our other 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 DesCAARTesTM trial 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.

 

The coronavirus disease, or COVID-19, pandemic and the future outbreak of other highly infectious or contagious diseases could seriously harm our research, development and potential future commercialization efforts, increase our costs and expenses and have a material adverse effect on our business, financial condition and results of operations.

 

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

 

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 which 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.

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, including, without limitation, risks, uncertainties and assumptions regarding the impact of the COVID-19 pandemic on our business, operations, strategy, goals and anticipated timelines, our ongoing and planned preclinical activities, our ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, our timelines for regulatory submissions and our financial position 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 program, including our clinical trial of DSG3-CAART, or the DesCAARTesTM trial, and our other product candidates, including statements regarding the timing of initiation and completion of the clinical trials and the period during which the results of the clinical trials will become available;

 

the timing of and our ability to obtain and maintain regulatory approval of our product candidates, including DSG3-CAART, MuSK-CAART, FVIII-CAART, DSG3/1-CAART and PLA2R-CAART, 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;

 

the impact of any business interruptions to our operations, including the timing and enrollment of patients in our ongoing and planned clinical trials and our planned Investigational New Drug application submissions, or to those of our clinical sites, manufacturers, suppliers, or other vendors resulting from the COVID-19 pandemic or similar public health crisis;

 

our expected use of proceeds from the initial public offering and from sales of our common stock in “at-the-market” offerings and the period over which such proceeds, together with existing cash, will be sufficient to meet our operating needs;

 

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

 

our plan to infuse our DSG3-CAART product candidate without lymphodepletion or other preconditioning agents initially in our DesCAARTesTM trial;

 

the potential advantages of our proprietary Cabaletta Approach for selective B cell Ablation platform, called our CABATM platform, and our product candidates;

 

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

 

the potential benefits and success of our arrangements and our expanded sponsored research agreement with the Trustees of the University of Pennsylvania, or Penn, and the Children’s Hospital of Philadelphia, or CHOP, and our scientific co-founders, Drs. Milone and Payne;

 

our ability to successfully commercialize our product candidates, including DSG3-CAART and our other product candidates;

 

the potential receipt of revenue from future sales of DSG3-CAART and our other product candidates;

 

the rate and degree of market acceptance and clinical utility of DSG3-CAART and our other product candidates;

 

our estimates regarding the potential market opportunity for DSG3-CAART and our 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 DSG3-CAART and our other product candidates;

 

our ability to obtain funding for our operations, including funding necessary to initiate and complete our  DesCAARTesTM trial and our ongoing preclinical studies of MuSK-CAART, DSG3/1-CAART, FVIII-CAART and PLA2R-CAART;

 

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

 

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;

 

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; 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.

 

2

 

 

 


 

 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

CABALETTA BIO, INC.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

 

September 30,

2021

 

 

December 31,

2020

 

Assets

 

(unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

118,260

 

 

$

101,429

 

Short-term investments

 

 

1,000

 

 

 

7,233

 

Prepaid expenses and other current assets

 

 

1,592

 

 

 

4,873

 

Total current assets

 

 

120,852

 

 

 

113,535

 

Property and equipment, net

 

 

1,462

 

 

 

890

 

Other assets

 

 

324

 

 

 

299

 

Total Assets

 

$

122,638

 

 

$

114,724

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,707

 

 

$

1,243

 

Accrued and other current liabilities

 

 

4,316

 

 

 

3,937

 

Total current liabilities

 

 

6,023

 

 

 

5,180

 

Commitments and Contingencies (see Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.00001 par value: 10,000,000 shares authorized as of

    September 30, 2021 and December 31, 2020, respectively; no shares issued or

    outstanding at September 30, 2021 and December 31, 2020

 

 

 

 

 

 

Voting and non-voting common stock, $0.00001 par value: 150,000,000 (143,590,481 voting and 6,409,519 non-voting) shares authorized as of September 30, 2021 and December 31, 2020, respectively; 27,731,638 (23,419,138 voting and 4,312,500 non-voting) and 24,062,775 (19,387,160 voting and 4,675,615 non-voting) shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

215,314

 

 

 

175,836

 

Accumulated other comprehensive income

 

 

 

 

 

6

 

Accumulated deficit

 

 

(98,699

)

 

 

(66,298

)

Total stockholders’ equity

 

 

116,615

 

 

 

109,544

 

Total liabilities and stockholders’ equity

 

$

122,638

 

 

$

114,724

 

 

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

3

 

 

 


 

CABALETTA BIO, INC.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

8,169

 

 

$

5,650

 

 

$

22,575

 

 

$

15,601

 

General and administrative

 

 

3,394

 

 

 

2,766

 

 

 

9,845

 

 

 

8,902

 

Total operating expenses

 

 

11,563

 

 

 

8,416

 

 

 

32,420

 

 

 

24,503

 

Loss from operations

 

 

(11,563

)

 

 

(8,416

)

 

 

(32,420

)

 

 

(24,503

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

3

 

 

 

23

 

 

 

19

 

 

 

473

 

Net loss

 

$

(11,560

)

 

$

(8,393

)

 

$

(32,401

)

 

$

(24,030

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(1

)

 

 

1

 

 

 

(6

)

 

 

12

 

Net comprehensive loss

 

$

(11,561

)

 

$

(8,392

)

 

$

(32,407

)

 

$

(24,018

)

Net loss per share of voting and non-voting common stock, basic and diluted

 

$

(0.45

)

 

$

(0.36

)

 

$

(1.31

)

 

$

(1.09

)

 

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

 

4

 

 

 


 

 

CABALETTA BIO, INC.

Condensed Statements of Stockholders’ Equity

(in thousands, except share amounts)

(unaudited)

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in  Capital

 

 

Accumulated Other Comprehensive Income

 

 

Accumulated Deficit

 

 

Total

Stockholders’ Equity

 

Balance—December 31, 2019

 

24,034,022

 

 

$

 

 

$

171,280

 

 

$

 

 

$

(32,959

)

 

$

138,321

 

Stock-based compensation

 

 

 

 

 

 

 

873

 

 

 

 

 

 

 

 

 

873

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,485

)

 

 

(7,485

)

Balance—March 31, 2020

 

24,034,022

 

 

$

 

 

$

172,153

 

 

$

 

 

$

(40,444

)

 

$

131,709

 

Stock-based compensation

 

 

 

 

 

 

 

1,067

 

 

 

 

 

 

 

 

 

1,067

 

Net unrealized gains on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

11

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,152

)

 

 

(8,152

)

Balance—June 30, 2020

 

24,034,022

 

 

$

 

 

$

173,220

 

 

$

11

 

 

$

(48,596

)

 

$

124,635

 

Stock-based compensation

 

 

 

 

 

 

 

1,127

 

 

 

 

 

 

 

 

 

1,127

 

Issuance of common stock in connection with exercise of stock options

 

21,445

 

 

 

 

 

 

135

 

 

 

 

 

 

 

 

 

135

 

Net unrealized gains on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,393

)

 

 

(8,393

)

Balance—September 30, 2020

 

24,055,467

 

 

$

 

 

$

174,482

 

 

$

12

 

 

$

(56,989

)

 

$

117,505

 

 

 

 

5

 

 

 


 

 

CABALETTA BIO, INC.

Condensed Statements of Stockholders’ Equity

(in thousands, except share amounts)

(unaudited)

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in  Capital

 

 

Accumulated Other Comprehensive Income

 

 

Accumulated Deficit

 

 

Total

Stockholders’ Equity

 

Balance—December 31, 2020

 

24,062,775

 

 

$

 

 

$

175,836

 

 

$

6

 

 

$

(66,298

)

 

$

109,544

 

Stock-based compensation

 

 

 

 

 

 

 

1,310

 

 

 

 

 

 

 

 

 

1,310

 

Common stock issuance, net of $67 of issuance costs

 

194,189

 

 

 

 

 

 

2,165

 

 

 

 

 

 

 

 

 

2,165

 

Net unrealized losses on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,702

)

 

 

(9,702

)

Balance—March 31, 2021

 

24,256,964

 

 

$

 

 

$

179,311

 

 

$

3

 

 

$

(76,000

)

 

$

103,314

 

Stock-based compensation

 

 

 

 

 

 

 

1,385

 

 

 

 

 

 

 

 

 

1,385

 

Common stock issuance, net of $237 of issuance costs

 

701,469

 

 

 

 

 

 

7,665

 

 

 

 

 

 

 

 

 

7,665

 

Issuance of common stock in connection with exercise of stock options

 

9,563

 

 

 

 

 

 

60

 

 

 

 

 

 

 

 

 

60

 

Issuance of common stock under employee stock purchase plan

 

4,834

 

 

 

 

 

 

46

 

 

 

 

 

 

 

 

 

46

 

Net unrealized losses on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

 

 

 

(2

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,139

)

 

 

(11,139

)

Balance—June 30, 2021

 

24,972,830

 

 

$

 

 

$

188,467

 

 

$

1

 

 

$

(87,139

)

 

$

101,329

 

Stock-based compensation

 

 

 

 

 

 

 

1,508

 

 

 

 

 

 

 

 

 

1,508

 

Common stock issuance, net of $769 of issuance costs

 

2,710,347

 

 

 

 

 

 

24,880

 

 

 

 

 

 

 

 

 

24,880

 

Issuance of common stock in connection with exercise of stock options

 

48,461

 

 

 

 

 

 

459

 

 

 

 

 

 

 

 

 

459

 

Net unrealized losses on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,560

)

 

 

(11,560

)

Balance—September 30, 2021

 

27,731,638

 

 

$

 

 

$

215,314

 

 

$

 

 

$

(98,699

)

 

$

116,615

 

 

 

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

 

6

 

 

 


 

 

CABALETTA BIO, INC.

Condensed Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(32,401

)

 

$

(24,030

)

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

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

4,203

 

 

 

3,067

 

Amortization of premium on investments

 

 

62

 

 

 

81

 

Depreciation

 

 

499

 

 

 

244

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

3,280

 

 

 

1,871

 

Other assets

 

 

(25

)

 

 

(138

)

Accounts payable

 

 

409

 

 

 

59

 

Accrued and other current liabilities

 

 

379

 

 

 

1,249

 

Net cash used in operating activities

 

 

(23,594

)

 

 

(17,597

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(1,015

)

 

 

(408

)

Purchases of investments

 

 

 

 

 

(11,097

)

Proceeds from maturities of investments

 

 

6,165

 

 

 

1,633

 

Net cash provided by (used in) investing activities

 

 

5,150

 

 

 

(9,872

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

34,710

 

 

 

(191

)

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

 

 

519

 

 

 

135

 

Proceeds from the issuance of common stock under employee stock purchase plan

 

 

46

 

 

 

 

Net cash provided by (used in) financing activities

 

 

35,275

 

 

 

(56

)

Net increase (decrease) in cash and cash equivalents

 

 

16,831

 

 

 

(27,525

)

Cash and cash equivalents—beginning of period

 

 

101,429

 

 

 

136,204

 

Cash and cash equivalents—end of period

 

$

118,260

 

 

$

108,679

 

Supplemental disclosures of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Property and equipment purchases included in accounts payable

 

$

76

 

 

$

227

 

 

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

7

 

 

 


 

CABALETTA BIO, INC.

Notes to Unaudited Condensed 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 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 B cell-mediated autoimmune diseases.

Principal operations commenced in April 2018, when the Company executed sponsored research agreements with the Trustees of the University of Pennsylvania (Penn).

On October 29, 2019, the Company completed its initial public offering (IPO) of 6,800,000 shares of common stock at an offering price of $11.00 per share. The Company received net proceeds of $66,156 after deducting underwriting discounts, commissions and estimated offering expenses. In connection with the IPO, the Company’s outstanding shares of Convertible Preferred Stock were automatically converted into 12,904,534 shares of common stock. In November 2019, the underwriters partially exercised their option and purchased an additional 475,501 shares of common stock resulting in net proceeds to the Company of approximately $4,864, after deducting underwriting discounts and commissions.

Risks and Uncertainties

The Company does not expect to generate revenue from sales of engineered T cell therapies for B cell-mediated 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 currently dependent on the University of Pennsylvania (Penn) for much of its preclinical research, clinical research and development activities and initial manufacturing activities (Note 5). 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.

In December 2019, a novel strain of coronavirus (COVID-19) surfaced in Wuhan, China and has since reached multiple other regions and countries. The COVID-19 pandemic continues to evolve and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures, which have delayed the commencement of non-COVID-19-related clinical trials, among other restrictions. The extent to which COVID-19 impacts the Company’s operations or those of its third party partners will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including new information that may emerge concerning the severity of COVID-19, the impact of new strains of the virus, the effectiveness, availability and utilization of vaccines and the actions to contain COVID-19 or treat its impact, among others. The Company’s financial results to date have not been significantly impacted by COVID-19, however, the Company cannot at this time predict the specific extent, duration, or full impact that the ongoing COVID-19 pandemic will have on its financial condition, operations, and business plans, including its ability to raise additional capital, the timing and enrollment of patients in its ongoing and planned clinical trials, future financings and other expected milestones of its product candidates.

8

 

 

 


 

 

Liquidity

The Company has sustained annual operating losses since inception and expects to continue to generate operating losses for the foreseeable future. The Company’s ultimate success depends on the outcome of its research and development activities. The Company has cash and cash equivalents and investments of $119,260 as of September 30, 2021. Through September 30, 2021, the Company has incurred an accumulated deficit of $98,699. 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. The Company expects that its cash and cash equivalents as of September 30, 2021, will be sufficient to fund its projected operations for at least 12 months following the date the Company files this Quarterly Report on Form 10-Q with the Securities and Exchange Commission (SEC).

 

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying unaudited interim 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.

In the opinion of management, the accompanying unaudited interim 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 September 30, 2021 and the results of its operations and its cash flows for the three and nine months ended September 30, 2021 and 2020. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. The balance sheet as of December 31, 2020 included herein was derived from the audited financial statements as of that date. The unaudited interim financial statements, presented herein, do not contain the required disclosures under GAAP for annual financial statements. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements, which are included in the Company’s 2020 Annual Report on Form 10-K, filed with the SEC on March 16, 2021 (2020 Annual Report).

Use of Estimates

The preparation of 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 financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, the fair value of stock-based compensation, the valuation allowance on the Company’s deferred tax assets and certain accruals. 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 primarily of cash and cash equivalents, which are primarily invested in U.S. treasury-based money market funds, and available-for-sale debt securities, which are invested in investment grade corporate bonds with high credit quality issuers. These investments have maturities in 2021. A portion of the Company’s cash is maintained at a federally insured financial institution. The deposits held at this institution are in excess of 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 due to the financial position of the depository institution in which those deposits are held. The cash in this account is swept daily into U.S. treasury-based and U.S. government-based money market funds. The Company has no off‑balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements.


9

 

 

 


 

 

Significant Accounting Policies

 

There have been no significant changes to the Company’s accounting policies during the three months ended September 30, 2021, 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 2020 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 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.

Emerging Growth Company Status

The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

10

 

 

 


 

Recently Issued Accounting Pronouncements

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), with guidance regarding the accounting for and disclosure of leases. The update requires lessees to recognize the liabilities related all leases, including operating leases, with a term greater than 12 months on the balance sheet. This update also requires lessees and lessors to disclose key information about their leasing transactions. This guidance is effective for public companies for annual and interim periods beginning after December 15, 2018. In June 2020, the FASB issued ASU 2020-05, Revenue from Contracts with Customers (Topic 606) and Leases (Topic 842), which granted a one-year effective date delay for certain companies to fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. Early adoption is permitted. As an Emerging Growth Company, the Company expects to adopt Topic 842 in 2022 and has not yet finalized the assessment of the impact that Topic 842 will have on its financial statements or financial statement disclosures.

3. Fair Value Measurements

Fair value of financial instruments

At September 30, 2021 and December 31, 2020, the Company’s financial instruments included cash and cash equivalents, accounts payable and accrued expenses. The carrying amounts reported in the Company's financial statements for these instruments approximate their respective fair values because of the short-term nature of these instruments.

The following tables present financial 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:

 

 

September 30, 2021

 

 

 

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 and Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

118,260

 

 

$

118,260

 

 

$

 

 

$

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

 

1,000

 

 

 

 

 

 

1,000

 

 

 

 

Total

 

$

119,260

 

 

$

118,260

 

 

$

1,000

 

 

$

 

 

 

 

December 31, 2020

 

 

 

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 and Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

101,429

 

 

$

101,429

 

 

$

 

 

$

 

Short-term investments: