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, 2024

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: 001-38841

 

Precision BioSciences, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

20-4206017

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

302 East Pettigrew St., Suite A-100

Durham, North Carolina

27701

(Address of principal executive offices)

(Zip Code)

 

(919) 314-5512

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

 

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.000005 per share

DTIL

The Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See 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 3, 2024, the registrant had 6,925,598 shares of common stock, $0.000005 par value per share, outstanding.

 

 


 

Table of Contents

 

Page

 

Forward-Looking Statements

3

 

Risk Factor Summary

5

PART I.

FINANCIAL INFORMATION

6

Item 1.

Financial Statements (unaudited)

6

Condensed Balance Sheets

6

Condensed Statements of Operations

8

Condensed Statements of Changes in Stockholders’ Equity

9

Condensed Statements of Cash Flows

10

Notes to Condensed Financial Statements

11

Item 2.

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

30

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

43

Item 4.

Controls and Procedures

43

PART II.

OTHER INFORMATION

44

Item 1.

Legal Proceedings

44

Item 1A.

Risk Factors

44

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

93

Item 3.

Defaults Upon Senior Securities

93

Item 4.

Mine Safety Disclosures

93

Item 5.

Other Information

93

Item 6.

Exhibits

93

 

Signatures

95

 

 

 

 

 

 

2


 

 

FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of present and historical facts contained in this Quarterly Report on Form 10-Q, including, without limitation, statements regarding our future results of operations and financial position, business strategy and approach, including related results, prospective products, use and development of licensed products, planned preclinical studies and clinical trials, or discontinuance thereof, the status and results of our preclinical studies, expected release of interim data, expectations regarding the use and effects of ARCUS, including in connection with in vivo genome editing, collaborations and potential new partnerships or alternative opportunities for our product candidates, potential new application filings and regulatory approvals, research and development costs, timing, expected results and likelihood of success, as well as plans and objectives of management for future operations may be forward-looking statements. Without limiting the foregoing, in some cases, you can identify forward-looking statements by terms such as “aim,” “may,” “will,” “should,” “expect,” “exploring,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. No forward-looking statement is a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified in Part II. Item 1A. “Risk Factors” and Part I. Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These risks and uncertainties include, but are not limited to:

our ability to become profitable;
our ability to procure sufficient funding to advance our programs;
risks associated with raising additional capital and requirements under our current debt instruments and effects of restrictions thereunder;
our operating expenses and our ability to predict what those expenses will be;
our limited operating history;
the success of our programs and product candidates in which we expend our resources;
our limited ability or inability to assess the safety and efficacy of our product candidates;
the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology;
our dependence on our ARCUS technology;
the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies;
public perception about genome editing technology and its applications;
competition in the genome editing, biopharmaceutical, and biotechnology fields;
our or our collaborators’ ability to identify, develop and commercialize product candidates;
potential product liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates;
the U.S. and foreign regulatory landscape applicable to our and our collaborators’ development of product candidates;
our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials;
potential manufacturing problems associated with the development or commercialization of any of our product candidates;
delays or difficulties in our or our collaborators’ ability to enroll patients;
changes in interim “top-line” and initial data that we announce or publish;

3


 

if our product candidates do not work as intended or cause undesirable side effects;
risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith;
our ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations;
our or our collaborators’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate;
the rate and degree of market acceptance of any of our product candidates;
our ability to effectively manage the growth of our operations;
our ability to attract, retain, and motivate executives and personnel;
effects of system failures and security breaches;
insurance expenses and exposure to uninsured liabilities;
effects of tax rules;
effects of any pandemic, epidemic, or outbreak of an infectious disease;
the success of our existing collaboration and other license agreements and our ability to enter into new collaboration arrangements;
our current and future relationships with and reliance on third parties including suppliers and manufacturers;
our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates;
potential litigation relating to infringement or misappropriation of intellectual property rights;
effects of natural and manmade disasters, public health emergencies and other natural catastrophic events;
effects of sustained inflation, supply chain disruptions and major central bank policy actions;
market and economic conditions; and
risks related to ownership of our common stock, including fluctuations in our stock price; and
our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges.

Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. All forward-looking statements contained herein speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

As used in this Quarterly Report on Form 10-Q, unless otherwise stated or the context requires otherwise, references to “Precision,” the “Company,” “we,” “us,” and “our,” refer to Precision BioSciences, Inc.

 

4


 

 

RISK FACTOR SUMMARY

Our business is subject to numerous risks and uncertainties, including those described in Part II. Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. You should carefully consider these risks and uncertainties when investing in our common stock. Some of the principal risks and uncertainties include the following.

We have incurred significant operating losses since our inception and expect to continue to incur losses for the foreseeable future. We have not been profitable and may not achieve or maintain profitability.
We will need substantial additional funding, and if we are unable to raise a sufficient amount of capital when needed on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts.
We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.
ARCUS is a novel technology, making it difficult to predict the time, cost and potential success of product candidate development. We have not yet been able to assess the safety and efficacy of most of our product candidates in humans.
We are heavily dependent on the successful development and translation of ARCUS, and due to the early stages of our product development operations, we cannot give any assurance that any product candidates will be successfully developed and commercialized.
Adverse public perception of genome editing may negatively impact the developmental progress or commercial success of products that we develop alone or with collaborators.
We face significant competition in industries experiencing rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop product candidates or treatments that are safer or more effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any of our product candidates.
Our future profitability, if any, will depend in part on our ability and the ability of our collaborators to commercialize any products that we or our collaborators may develop in markets throughout the world. Commercialization of products in various markets could subject us to risks and uncertainties.
Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any products that we develop alone or with collaborators.
The regulatory landscape that will apply to development of therapeutic product candidates by us or our collaborators is rigorous, complex, uncertain and subject to change, which could result in delays or termination of development of such product candidates or unexpected costs in obtaining regulatory approvals.
Clinical trials are difficult to design and implement, expensive, time-consuming and involve an uncertain outcome, and the inability to successfully and timely conduct clinical trials and obtain regulatory approval for our product candidates would substantially harm our business.
Any product candidates that we or our collaborators or other licensees may develop will be novel and may be complex and difficult to manufacture, and if we experience manufacturing problems, it could result in delays in development and commercialization of such product candidates or otherwise harm our business.
Even if we obtain regulatory approval for any products that we develop alone or with collaborators, such products will remain subject to ongoing regulatory requirements, which may result in significant additional expense.
Even if any product we develop alone or with collaborators receives marketing approval, such product may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
Our future success depends on our key executives, as well as attracting, retaining and motivating qualified personnel.
Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock.
Once we are no longer an emerging growth company, a smaller reporting company or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results.

5


 

Part I. Financial information

 

Item 1. Financial Statements.

Precision Biosciences, Inc.

Condensed Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

March 31, 2024

 

 

December 31, 2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

137,766

 

 

$

116,678

 

Accounts receivable

 

 

390

 

 

 

901

 

Prepaid expenses

 

 

9,254

 

 

 

5,977

 

Convertible note receivable

 

 

11,553

 

 

 

11,897

 

Assets held for sale

 

 

378

 

 

 

487

 

Contract asset

 

 

1,359

 

 

 

 

Other current assets

 

 

128

 

 

 

419

 

Total current assets

 

 

160,828

 

 

 

136,359

 

Property, equipment, and software—net

 

 

5,286

 

 

 

6,338

 

Intangible assets—net

 

 

386

 

 

 

400

 

Right-of-use assets—net

 

 

7,979

 

 

 

8,263

 

Investment in equity securities

 

 

3,206

 

 

 

3,206

 

Note receivable—net

 

 

6,818

 

 

 

4,990

 

Other assets

 

 

238

 

 

 

225

 

Total assets

 

$

184,741

 

 

$

159,781

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,136

 

 

$

2,968

 

Accrued compensation

 

 

1,220

 

 

 

4,978

 

Accrued research and development expenses

 

 

656

 

 

 

1,557

 

Deferred revenue

 

 

2,406

 

 

 

12,035

 

Loan payable-net

 

 

22,460

 

 

 

22,412

 

Lease liabilities

 

 

1,182

 

 

 

1,133

 

Other current liabilities

 

 

2,772

 

 

 

2,391

 

Current liabilities of discontinued operations

 

 

1,506

 

 

 

2,513

 

Total current liabilities

 

 

33,338

 

 

 

49,987

 

Deferred revenue

 

 

74,766

 

 

 

73,082

 

Lease liabilities

 

 

7,411

 

 

 

7,723

 

Warrant liability

 

 

22,020

 

 

 

 

Contract liabilities

 

 

10,000

 

 

 

10,000

 

Noncurrent liabilities of discontinued operations

 

 

 

 

 

128

 

Total liabilities

 

 

147,535

 

 

 

140,920

 

Commitments and contingencies (Note 4)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock: $0.0001 par value— 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; no shares issued and outstanding as of March 31, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock: $0.000005 par value— 200,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 6,943,254 shares issued and 6,916,239 shares outstanding as of March 31, 2024; 4,191,053 shares issued and 4,164,038 shares outstanding as of December 31, 2023

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

519,200

 

 

 

509,443

 

Accumulated deficit

 

 

(481,043

)

 

 

(489,631

)

Treasury stock

 

 

(952

)

 

 

(952

)

Total stockholders’ equity

 

 

37,206

 

 

 

18,861

 

Total liabilities and stockholders’ equity

 

$

184,741

 

 

$

159,781

 

 

6


 

See notes to condensed financial statements

7


 

Precision Biosciences, Inc.

Condensed Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

For the Three Months Ended March 31,

 

 

 

2024

 

 

2023

 

Revenue

 

$

17,584

 

 

$

8,780

 

Operating expenses

 

 

 

 

 

 

Research and development

 

 

13,343

 

 

 

11,048

 

General and administrative

 

 

8,428

 

 

 

11,086

 

Total operating expenses

 

 

21,771

 

 

 

22,134

 

Operating loss

 

 

(4,187

)

 

 

(13,354

)

Other income (expense):

 

 

 

 

 

 

Gain (loss) from equity method investment

 

 

1,713

 

 

 

(1,341

)

Loss on changes in fair value

 

 

(348

)

 

 

(769

)

Gain on change in fair value of warrant liability

 

 

10,386

 

 

 

 

Interest expense

 

 

(574

)

 

 

(522

)

Interest income

 

 

1,663

 

 

 

2,043

 

Loss on disposal of assets

 

 

(65

)

 

 

(7

)

Total other income (expense)

 

 

12,775

 

 

 

(596

)

Income (loss) from continuing operations

 

$

8,588

 

 

$

(13,950

)

Loss from discontinued operations

 

 

 

 

 

(11,110

)

Net income (loss)

 

$

8,588

 

 

$

(25,060

)

 

 

 

 

 

 

 

Net income (loss) per share

 

 

 

 

 

 

Basic

 

$

1.70

 

 

$

(6.75

)

Diluted

 

$

1.70

 

 

$

(6.75

)

 

 

 

 

 

 

 

Weighted-average shares of common stock outstanding

 

 

 

 

 

 

Basic

 

 

5,060,978

 

 

 

3,709,894

 

Diluted

 

 

5,063,406

 

 

 

3,709,894

 

See notes to condensed financial statements

8


 

Precision Biosciences, Inc.

Condensed Statements of Changes in

Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Treasury

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Stock

 

 

Equity

 

Balance- December 31, 2022

 

 

3,725,689

 

 

$

1

 

 

$

489,696

 

 

$

(428,312

)

 

$

(952

)

 

$

60,433

 

Stock option exercises

 

 

1,718

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

30

 

Issuance of common stock under employee stock purchase plan

 

 

9,303

 

 

 

 

 

 

266

 

 

 

 

 

 

 

 

 

266

 

Share-based compensation expense

 

 

 

 

 

 

 

 

4,092

 

 

 

 

 

 

 

 

 

4,092

 

Proceeds from issuance of common stock, net of issuance cost

 

 

18,012

 

 

 

 

 

 

416

 

 

 

 

 

 

 

 

 

416

 

Restricted stock units vested

 

 

16,717

 

 

 

 

 

 

-

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(25,060

)

 

 

 

 

 

(25,060

)

Balance- March 31, 2023

 

 

3,771,439

 

 

$

1

 

 

$

494,500

 

 

$

(453,372

)

 

$

(952

)

 

$

40,177

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance- December 31, 2023

 

 

4,191,053

 

 

$

1

 

 

$

509,443

 

 

$

(489,631

)

 

$

(952

)

 

 

18,861

 

Issuance of common stock under employee stock purchase plan

 

 

9,037

 

 

 

 

 

 

112

 

 

 

 

 

 

 

 

 

112

 

Share-based compensation expense

 

 

 

 

 

 

 

 

2,906

 

 

 

 

 

 

 

 

 

2,906

 

Proceeds from issuance of common stock to collaboration partners and licensees

 

 

97,360

 

 

 

 

 

 

905

 

 

 

 

 

 

 

 

 

905

 

Proceeds from issuance of common stock and warrants through underwritten offering, net of issuance cost

 

 

2,500,000

 

 

 

 

 

 

4,610

 

 

 

 

 

 

 

 

 

4,610

 

Proceeds from issuance of common stock through ATM facility, net of issuance cost

 

 

98,943

 

 

 

 

 

 

1,224

 

 

 

 

 

 

 

 

 

1,224

 

Restricted stock units vested

 

 

46,861

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

 

 

 

 

 

 

 

 

 

 

8,588

 

 

 

 

 

 

8,588

 

Balance- March 31, 2024

 

 

6,943,254

 

 

$

1

 

 

$

519,200

 

 

$

(481,043

)

 

$

(952

)

 

$

37,206

 

 

See notes to condensed financial statements

 

9


 

Precision Biosciences, Inc.

Condensed Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

For the Three Months Ended March 31,

 

 

 

2024

 

 

2023

 

Cash flows used in operating activities:

 

 

 

 

 

 

Net income (loss)

 

$

8,588

 

 

$

(25,060

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

1,143

 

 

 

1,953

 

Share-based compensation

 

 

2,906

 

 

 

4,092

 

Loss on disposal of assets

 

 

65

 

 

 

7

 

Non-cash interest expense

 

 

227

 

 

 

213

 

Amortization of right-of-use assets

 

 

284

 

 

 

325

 

Gain on changes in fair value

 

 

348

 

 

 

769

 

(Gain) loss from equity method investment

 

 

(1,713

)

 

 

1,341

 

Amortization of discount on note receivable

 

 

(114

)

 

 

(94

)

Gain on change in fair value of warrant liability

 

 

(10,386

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses

 

 

(3,277

)

 

 

(872

)

Accounts receivable

 

 

511

 

 

 

26

 

Contract asset

 

 

(1,359

)

 

 

 

Other assets and other current assets

 

 

(57

)

 

 

(571

)

Accounts payable

 

 

(2,102

)

 

 

(559

)

Other liabilities and other current liabilities

 

 

(5,837

)

 

 

(4,516

)

Deferred revenue

 

 

(7,945

)

 

 

(8,032

)

Lease liabilities

 

 

(263

)

 

 

(486

)

Net cash used in operating activities

 

 

(18,981

)

 

 

(31,464

)

Cash flows used in investing activities:

 

 

 

 

 

 

Purchases of property, equipment and software

 

 

(86

)

 

 

(521

)

Purchases of intangible assets

 

 

 

 

 

(200

)

Proceeds from sale of equipment

 

 

60

 

 

 

 

Net cash used in investing activities

 

 

(26

)

 

 

(721

)

Cash flows provided by financing activities:

 

 

 

 

 

 

Proceeds from stock option exercises

 

 

 

 

 

30

 

Proceeds from employee stock purchase plan

 

 

112

 

 

 

266

 

Proceeds from offering of common stock and warrants, net of issuance costs

 

 

39,078

 

 

 

445

 

Proceeds from issuance of common stock to collaboration partners and licensees

 

 

905

 

 

 

 

Net cash provided by financing activities

 

 

40,095

 

 

 

741

 

Net increase (decrease) in cash and cash equivalents

 

 

21,088

 

 

 

(31,444

)

Cash and cash equivalents—beginning of period

 

 

116,678

 

 

 

189,576

 

Cash and cash equivalents —end of period

 

$

137,766

 

 

$

158,132

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

Property, equipment and software additions included in accounts payable and other current liabilities

 

$

6

 

 

$

43

 

Cash paid for interest

 

$

526

 

 

$

464

 

See notes to condensed financial statements

10


 

Precision BioSciences, Inc.

Notes to Condensed Financial Statements (Unaudited)

NOTE 1: DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Description of Business

Precision BioSciences, Inc. (the “Company”) was incorporated on January 26, 2006 under the laws of the State of Delaware and is based in Durham, North Carolina. The Company is a gene editing company dedicated to improving life by developing in vivo therapies for genetic and infectious diseases with the application of the Company’s wholly-owned proprietary ARCUS genome editing platform.

Since its inception, the Company has devoted substantially all of its efforts to research and development activities, recruiting skilled personnel, establishing its intellectual property portfolio and providing general and administrative support for these operations. The Company is subject to a number of risks similar to those of other companies conducting early-stage research and development of product candidates. Principal among these risks are dependence on key individuals and intellectual property, competition from other products and companies, and the technical risks associated with the successful research, development and clinical manufacturing of its product candidates. The Company’s success is dependent upon its ability to continue to raise additional capital in order to fund ongoing research and development, obtain regulatory approval of its products, successfully commercialize its products, generate revenue, meet its obligations, and, ultimately, attain profitable operations.

Unaudited Interim Financial Information

The accompanying unaudited condensed financial statements and notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and note disclosures normally included in the annual financial statements, prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”), have been condensed or omitted pursuant to those rules and regulations. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 27, 2024.

The unaudited condensed financial statements have been prepared on the same basis as the audited financial statements. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair presentation of the Company’s condensed financial position as of March 31, 2024 and condensed results of operations for the three months ended March 31, 2024 and 2023 and the condensed cash flows for the three months ended March 31, 2024 and 2023, have been made. The Company’s condensed results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024.

Discontinued Operations

In August 2023, the Company announced its strategic decision to operate as a single platform company focused exclusively on developing in vivo gene editing therapies with the completion of the sale of its chimeric antigen receptor (“CAR”) T infrastructure to Imugene Limited, an Australian corporation (“Imugene Limited”), and its wholly-owned subsidiary Imugene (USA) Inc. (“Imugene US”), a Nevada corporation (collectively, “Imugene”). Additionally, the Company licensed its lead allogeneic CAR T candidate for cancer, azercabtagene zapreleucel (“azer-cel”), to Imugene.

Accordingly, the accompanying condensed financial statements have been recast for all periods presented to reflect the assets, liabilities and expenses related to the Company’s CAR T programs as discontinued operations (see Note 8, Discontinued Operations). The accompanying condensed financial statements are generally presented in conformity with the Company’s historical format.

11


 

Reverse Stock Split

On February 13, 2024, the Company amended its amended and restated certificate of incorporation in order to effect a 1-for-30 reverse stock split of its outstanding shares of capital stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every 30 shares of the Company’s common stock issued or outstanding were automatically reclassified into one new share of common stock, subject to the treatment of fractional shares as described below, without any action on the part of the holders. All historical share and per-share amounts reflected throughout the accompanying consolidated financial statements and other financial information in this Quarterly Report on Form 10-Q have been retroactively adjusted to reflect the Reverse Stock Split as if the split occurred as of the earliest period presented. The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value of the common stock. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who would otherwise have been entitled to receive fractional shares as a result of the Reverse Stock Split were entitled to a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing sales price per share of the common stock (as adjusted to give effect to the Reverse Stock Split) on The Nasdaq Capital Market on February 13, 2024, the last trading day immediately preceding the effective time of the Reverse Stock Split.

Summary of Significant Accounting Policies

The Company’s complete listing of significant accounting policies is set forth in Note 1, Description of Business and Summary of Significant Accounting Policies, to the Notes to Condensed Financial Statements on its Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Revenue Recognition for Contracts with Customers

The Company’s revenues are generated primarily through collaborative research, license, development and commercialization agreements.

ASC 606, Revenue from Contracts with Customers (“ASC 606”) applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

At contract inception, once the contract is determined to be within the scope of ASC 606, the Company evaluates the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determines whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract. Goods or services that meet these criteria are considered distinct performance obligations. If both these criteria are not met, the goods and services are combined into a single performance obligation. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, these options are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes.

The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. For the three months ended March 31, 2024, the Company did not record any cumulative catch-up adjustments on its contracts with customers. During the three months ended March 31, 2024, the Company recorded $9.0 million in revenue that was included in deferred revenue as of December 31, 2023.

Invoices issued as stipulated in contracts prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue within current liabilities in the accompanying condensed balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as noncurrent deferred

12


 

revenue. Amounts recognized as revenue, but not yet invoiced are generally recognized as contract assets in the other current assets line item in the accompanying condensed balance sheets.

Milestone Payments If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore revenue recognized is constrained as management is unable to assert that a reversal of revenue would not be probable. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment.

Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation linked to some or all of the royalty has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements.

Significant Financing Component – In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements.

Collaborative Arrangements – The Company has entered into collaboration agreements, which are within the scope of ASC 606, to discover, develop, manufacture and commercialize product candidates. The terms of these agreements typically contain multiple promises or obligations, which may include: (1) licenses, or options to obtain licenses, to use the Company’s technology, (2) research and development activities to be performed on behalf of the collaboration partner, and (3) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments the Company receives under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; clinical and development, regulatory, and sales milestone payments; and royalties on future product sales.

The Company analyzes its collaboration arrangements to assess whether the collaboration agreements are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, are within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above.

For additional discussion of accounting for collaboration revenues, see Note 6, Collaboration and License Agreements.

Derivative Financial Instruments

On March 1, 2024, the Company entered into an Underwriting Agreement with Guggenheim Securities, LLC (the “Underwriting Agreement”), relating to the offering, issuance and sale (the “March 2024 Public Offering”) of (a) 2,500,000 shares of the Company’s common stock, par value $0.000005 per share, and (b) warrants to purchase up to an aggregate of 2,500,000 shares of the Company’s common stock. The warrants entitle the holders to purchase up to

13


 

an aggregate of 2,500,000 shares of common stock and have a five-year term and an exercise price of $20.00 per share. Each warrant is exercisable immediately upon issuance, subject to certain limitations on beneficial ownership.

The Company evaluates all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, will be re-assessed at the end of each reporting period.

The warrants issued in the March 2024 Public Offering were recognized as derivative warrant liabilities in accordance with ASC 815. Accordingly, the Company recognized the warrant instruments as liabilities at fair value and will remeasure the instruments to fair value at each balance sheet date, with changes in fair value recognized in in the Company’s condensed statements of operations, until exercised or expiration. The fair value of the warrants were initially estimated using a Black-Scholes option pricing model. Derivative warrant liabilities are classified as non-current liabilities as their liquidation is not reasonably expected to require the use of current assets or require the creation of current liabilities.

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks.

14


 

NOTE 2: FAIR VALUE MEASUREMENTS

The following represents assets and liabilities measured at fair value on a recurring basis by the Company (in thousands):

March 31, 2024

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

14,142

 

 

$

14,142

 

 

$

 

 

$

 

Investment in iECURE

 

 

3,206

 

 

 

 

 

 

 

 

 

3,206

 

Imugene convertible note

 

 

11,553

 

 

 

 

 

 

11,553

 

 

 

 

Assets held for sale

 

 

378

 

 

 

 

 

 

 

 

 

378

 

 

 

$

29,279

 

 

$

14,142

 

 

$

11,553

 

 

$

3,584

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Final payment fee

 

$

220

 

 

$

 

 

$

220

 

 

$

 

Warrant liability

 

$

22,020

 

 

$

 

 

$

22,020

 

 

$

 

 

 

$

22,240

 

 

$

 

 

$

22,240

 

 

$

 

 

December 31, 2023

 

Fair Value

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

13,960

 

 

$

13,960

 

 

$

 

 

$

 

Investment in iECURE

 

 

3,206

 

 

 

 

 

 

 

 

 

3,206

 

Imugene convertible note

 

 

11,897

 

 

 

 

 

 

11,897

 

 

 

 

Assets held for sale

 

 

487

 

 

 

 

 

 

 

 

 

487

 

 

 

$

29,550

 

 

$

13,960

 

 

$

11,897

 

 

$

3,693

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Final payment fee

 

$

215

 

 

$

 

 

$

215

 

 

$

 

 

 

$

215

 

 

$

 

 

$

215

 

 

$

 

 

The following represents a reconciliation of assets measured and carried at fair value on a recurring basis with the use of significant unobservable inputs (Level 3) for the three months ended March 31, 2024 (in thousands):

 

Investment in iECURE

 

Assets held for sale

 

Balance December 31, 2023

 

$

3,206

 

$

487

 

Gains from changes in fair value included in earnings

 

 

 

Assets sold

 

 

 

109

 

Balance March 31, 2024

 

$

3,206

 

$

378

 

The carrying amounts of the Company’s accounts receivable, accounts payable, and accrued expenses and other current liabilities, approximate their respective fair values due to their short-term nature. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis and to minimize the use of unobservable inputs when determining their fair value. The three tiers are defined as follows:

Level 1—Observable inputs based on unadjusted quoted prices in active markets for identical assets or liabilities

Level 2—Inputs, other than quoted prices in active markets, that are observable either directly or indirectly

Level 3—Unobservable inputs for which there is little or no market data, which require the Company to develop its own assumptions

Cash Equivalents

As of March 31, 2024 and December 31, 2023, the Company held cash equivalents which were composed of investments in money market funds. The Company classifies investments in money market funds within Level 1 of the fair value hierarchy as the prices are available from quoted prices in active markets.

Investment in iECURE

15


 

In August 2021, the Company entered into an Equity Issuance Agreement with iECURE, Inc. (“iECURE”), pursuant to which iECURE issued the Company common stock in iECURE (the “iECURE equity”) as additional consideration for a license to use the Company’s PCSK9-directed ARCUS nuclease to insert genes into the PCSK9 locus to develop treatments for four pre-specified rare genetic diseases. On issuance, the Company accounted for the iECURE equity at fair value under ASC 825, Financial Instruments. Accordingly, the Company adjusts the carrying value of the iECURE equity to fair value each reporting period with any changes in fair value recorded to other income (expense). There was no change in the fair value of the iECURE equity during the three months ended March 31, 2024.

The Company classifies the iECURE equity within Level 3 of the fair value hierarchy as the assessed fair value was based on significant unobservable inputs given iECURE equity is not traded on a public exchange.

 

Assets Held for Sale

The fair values of property, plant, and equipment held for sale are classified as Level 3 in the fair value hierarchy due to a mix of unobservable inputs utilized such as independent research in the market as well as actual quotes from market participants.

 

Imugene Convertible Note

 

As partial consideration for the assets acquired by Imugene in connection with the asset purchase agreement (the "Imugene Purchase Agreement"), Imugene issued to the Company convertible notes pursuant to the terms and conditions set forth in a convertible note subscription deed (collectively, the “Imugene Convertible Note”) in an aggregate principal amount of $13 million. The Imugene Convertible Note is non-interest bearing and matures on August 15, 2024 (the "Maturity Date"). On the Maturity Date, the Imugene Convertible Note must be redeemed with cash, converted into ordinary shares of Imugene Limited at a conversion price based on the 10-day volume weighted average price (“VWAP”) of Imugene Limited’s ordinary shares prior to the date of conversion, or partially redeemed with cash and partially converted into shares, at Imugene’s discretion. There was an assessed $0.3 million loss on the change in fair value of the Imugene Convertible Note during the three months ended March 31, 2024.

 

The Company classifies the Imugene Convertible Note within Level 2 of the fair value hierarchy as the assessed fair value is based on observable market inputs including the risk-free rate and the ordinary share price, volume, and volatility.

Final Payment Fee

The Company is required to pay a final payment fee upon maturity of the Revolving Line (as defined in Note 3, Debt, below). The final payment fee was determined to be a derivative under ASC 815, Derivatives and Hedging (“ASC 815”), therefore these fees were initially measured at fair value and recorded as debt discount to be amortized to interest expense over the term of the Revolving Line. Accordingly, the Company will adjust the carrying value of the final payment fee to fair value each reporting period with any changes in fair value recorded to other income (expense). There was an assessed loss on change in fair value of the final payment fee of less than $0.1 million during the three months ended March 31, 2024.

The Company classifies the final payment fee within Level 2 of the fair value hierarchy as the assessed fair value is based on observable market inputs including the Company’s current borrowing rate on the Revolving Line. The final payment fee is included in the other current liabilities within the condensed balance sheet as of March 31, 2024 and December 31, 2023.

Warrant Liability

As of March 31, 2024, warrants representing 2,500,000 shares of common stock issued in the March 2024 Public Offering were outstanding. These warrants are classified as a liability since the warrants meet the classification requirements for liability accounting pursuant to ASC 815. This liability is subject to remeasurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value is recognized in the Company’s condensed consolidated statements of operations. The Company classifies the warrant liability within Level 2 of the fair value hierarchy as the assessed fair value is based on observable market inputs including the Company's stock price, risk-free rate, and volatility.

NOTE 3: DEBT

Revolving Line

Pursuant to the terms of the loan and security agreement with Banc of California (formerly known as Pacific Western Bank) the Company may request advances on a revolving line of credit of up to an aggregate principal of $30.0 million (as amended from time to time, the “Revolving Line”) at an annual interest rate equal to the greater of (a) 0.75% above the Prime rate (as defined in the

16


 

Revolving Line) and (b) 4.25%. As of March 31, 2024, the stated interest rate on the Revolving Line was 9.25% and the effective interest rate was 10.27%.

The Revolving Line maturity date is June 23, 2024 and all outstanding principal amounts are due upon maturity. The Company must also maintain an aggregate balance of unrestricted cash at Banc of California (not including amounts in certain specified accounts) equal to or greater than $10.0 million.

As of March 31, 2024 and December 31, 2023, $22.5 million in borrowings were outstanding under the Revolving Line and the unamortized debt discount balance was less than $0.1 million.

NOTE 4: COMMITMENTS AND CONTINGENCIES

Litigation

The Company is subject to various legal matters and claims in the ordinary course of business. Although the results of legal proceedings and claims cannot be predicted with certainty, in the opinion of management, there are currently no such known matters that will have a material effect on the financial condition, results of operations or cash flows of the Company.

Servier Program Purchase Agreement

On April 9, 2021, the Company entered into a program purchase agreement (the Program Purchase Agreement”) with Les Laboratoires Servier and Institut de Recherches Internationales Servier (collectively, “Servier”), pursuant to which the Company reacquired all of its global development and commercialization rights previously granted to Servier pursuant to the Development and Commercial License Agreement by and between Servier and the Company, dated February 24, 2016, as amended (the “Servier Agreement”), and mutually terminated the Servier Agreement.

The Program Purchase Agreement requires the Company to make certain payments to Servier based on the achievement of regulatory and commercial milestones for each product. Management assessed the likelihood of each of the regulatory and commercial milestones included in the Program Purchase Agreement in accordance with ASC 450, Contingencies. If the assessment of a contingency indicates that it is probable that the milestone will be achieved and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company’s condensed financial statements.

Accordingly, contingent liabilities of $10.0 million related to the Program Purchase Agreement are accrued and included in contract liabilities in the condensed balance sheets as of March 31, 2024 and December 31, 2023.

Leases

The Company has an operating lease for real estate in North Carolina and does not have any finance leases.

On October 16, 2023, the Company and Venable Historic, LLC, successor-in-interest to Venable Tenant, LLC (the “Landlord”), entered into a Tenth Amendment to Lease Agreement (the “Lease Amendment”), which amended certain terms of the Lease Agreement dated April 5, 2010, as amended (the “Original Lease”) with respect to the Company’s headquarters facilities located in Durham, North Carolina. Among other things, the Lease Amendment extends the term of the Original Lease for an additional period of five years commencing upon August 1, 2024 and up to and through July 31, 2029.

The Company has existing leases in which the non-lease components (e.g., common area maintenance, consumables, etc.) are paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use assets and lease liabilities but rather are reflected as an expense in the period incurred.

17


 

The elements of lease expense were as follows:

 

 

 

For the Three Months Ended March 31,

 

(in thousands)

 

2024

 

 

2023

 

Lease Cost

 

 

 

 

 

 

Operating lease cost

 

$

483

 

 

$

412

 

Short-term lease cost

 

189

 

 

184

 

Variable lease cost

 

 

81

 

 

 

244

 

Sublease income

 

 

(102

)

 

 

Total Lease Cost

 

$

651

 

 

$

840

 

 

 

 

 

 

 

 

Other Information

 

 

 

 

 

 

Operating cash flows used for operating leases

 

 

462

 

 

 

572

 

Operating right-of-use assets obtained in exchange for lease obligations

 

 

 

 

Operating lease liabilities arising from obtaining right-of-use assets

 

 

 

 

 

 

 

 

 

 

 

Operating Leases

 

 

 

 

 

 

Weighted-average remaining lease term (in years)

 

 

5.3

 

 

 

2.8

 

 

 

 

 

 

 

 

Operating Leases

 

 

 

 

 

 

Weighted-average discount rate

 

 

9.2

%

 

 

7.7

%

Pursuant to the Imugene Purchase Agreement, Imugene subleases from the Company space at the Company’s headquarters (the “Imugene Sublease”). As the Company is not relieved of its primary obligation to the lessor under the terms of the Imugene Sublease, the Company will continue to carry the related right-of-use assets and lease liabilities on its Condensed Balance Sheets and will net sublease income with lease cost in its condensed statements of operations.

Future lease payments under non-cancelable operating leases with terms of greater than one year as of March 31, 2024, were as follows:

 

(in thousands)

 

March 31, 2024

 

2024 (excluding the three months ended March 31, 2024)

 

$

1,426

 

2025

 

 

1,962

 

2026

 

 

2,019

 

2027

 

 

2,078

 

2028

 

 

2,140

 

2029 and beyond

 

 

1,269

 

Total lease payments

 

 

10,894

 

Less: imputed interest

 

 

2,301

 

Total operating lease liabilities

 

$

8,593

 

 

Guarantees

The Company agreed to act as a guarantor of Imugene’s assumption of the Company’s lease for its Manufacturing Center for Advanced Therapeutics (the “MCAT Lease”) through the lease expiration date of August 31, 2027. If Imugene (including any successor or assignee of Imugene) fails to pay rent due on the MCAT Lease, the lessor may have contractual recourse against the Company.

As of March 31, 2024, the Company’s guarantee consists of a contingent liability for aggregate minimum lease payments of approximately $5.4 million. No contract liability for the Company’s guarantee of Imugene’s performance on the MCAT Lease was recorded as of March 31, 2024, as it was not deemed probable that Imugene will be in default under the MCAT Lease.

 

Supply Agreements

 

The Company enters into contracts in the normal course of business with contract manufacturing organizations (“CMOs”) for the manufacture of clinical trial materials and contract research organizations (“CROs”) for clinical trial services. These agreements

18


 

provide for termination at the request of either party with less than one-year’s notice and are, therefore, cancelable contracts. If canceled, these agreements are not anticipated to have a material effect on the financial condition, results of operations, or cash flows of the Company.

NOTE 5: STOCKHOLDERS’ EQUITY

Capital Structure

As a result of the Reverse Stock Split, every 30 shares of the Company’s common stock issued or outstanding were automatically reclassified into one new share of common stock, subject to the treatment of fractional shares as described below, without any action on the part of the holders. The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value of the common stock.

On March 1, 2024, the Company entered into the Underwriting Agreement relating to the March 2024 Public Offering of (a) 2,500,000 shares of the Company’s common stock, par value $0.000005 per share, and (b) warrants to purchase up to an aggregate of 2,500,000 shares of the Company’s common stock. The warrants entitle the holders to purchase up to an aggregate of 2,500,000 shares of common stock and have a five-year term and an exercise price of $20.00 per share. Each warrant is exercisable immediately upon issuance, subject to certain limitations on beneficial ownership. The price to the public in the March 2024 Public Offering was $16.00 per share of common stock and accompanying warrants, which resulted in $37.0 million of net proceeds to the Company after deducting the underwriting discount and offering expenses of $3.0 million.

NOTE 6: COLLABORATION AND LICENSE AGREEMENTS

TG Therapeutics

On January 7, 2024, the Company entered into a license agreement (the “TG License Agreement”) with TG Cell Therapy, Inc. (“TG Subsidiary”) and its parent company, TG Therapeutics, Inc. (“TG Parent” and, together with TG Subsidiary, “TG Therapeutics”), pursuant to which the Company granted TG Subsidiary certain exclusive and non-exclusive license rights to develop, manufacture, and commercialize the Company’s allogeneic CAR T therapy azer-cel for autoimmune diseases and other indications outside of cancer.

Under the TG License Agreement, the Company is entitled to receive an upfront cash payment of $10.0 million (the “TG Upfront Payment”). The TG Upfront Payment of $10.0 million is comprised of (i) a $5.25 million cash payment that was paid to the Company on February 5, 2024, (ii) a $2.25 million cash payment that was paid to the Company on February 5, 2024, in exchange for 97,360 shares of the Company’s common stock at a price of $23.10 per share, a 100% premium to the 30-day volume-weighted average price (“VWAP”) prior to the date of the TG License Agreement, and (iii) a deferred cash payment of $2.5 million due within 12 months following the date of the TG License Agreement, payable in exchange for such number of shares of the Company’s common stock determined based on a price per share equal to the greater of (A) a 100% premium to the VWAP of the Company’s common stock for the 30 trading days prior to the date of payment or (B) a minimum price of $11.1660 determined in accordance with Nasdaq Listing Rule 5635(d) (the “Minimum Price”).

The Company is also entitled to an additional cash payment of $7.5 million in the event that TG Therapeutics achieves a certain clinical milestone that is expected to be achieved in the near-term (the “Initial Milestone Payment”), and additional payments upon the achievement of additional specified milestones of up to $288.6 million (the “Additional TG Milestone Payments”). As described below, up to $10.0 million of the cash payments potentially payable to the Company are payable in exchange for the issuance to TG Subsidiary by the Company of shares of the Company’s common stock (the “Company Stock Issuances”). The Initial Milestone Payment of $7.5 million, if payable, will consist of (i) a $5.25 million cash milestone payment and (ii) a $2.25 million cash payment payable in exchange for such number of shares of the Company’s common stock determined based on a price per share equal to the greater of (A) a 100% premium to the VWAP of the Company’s common stock for the 30 trading days prior to the achievement of such milestone or (B) the Minimum Price.

The Additional TG Milestone Payments become due upon the achievement of certain milestones as specified in the TG License Agreement. Included within the Additional TG Milestone Payments is a potential payment of $3.0 million in connection with achievement of a milestone specified in the TG License Agreement, payable in exchange for such number of shares of the Company’s common stock determined based on a price per share equal to the greater of (A) a 100% premium to the VWAP of the Company’s common stock for the 30 trading days prior to the achievement of such milestone or (B) the Minimum Price.

Subject to the terms and conditions of the TG License Agreement, TG Therapeutics is permitted to pay up to 50% of the value of each Additional Milestone Payment (other than the Additional Milestone Payment described above that would, upon achievement, involve

19


 

the issuance of $3.0 million of shares of the Company’s common stock) in freely tradable shares of common stock of TG Parent, valued based on the VWAP of the TG Parent shares of common stock on Nasdaq for the 30 trading days prior to the achievement of the applicable milestone.

If a licensed product under the TG License Agreement is approved and sold, TG Therapeutics is also required to pay the Company tiered royalties ranging from high-single-digit to low-double-digit percentages on net sales of the licensed product. TG Therapeutics’ obligation to pay royalties to the Company expires on a country-by-country and licensed product-by-licensed product basis, upon the latest to occur of (i) the expiration of the last-to-expire valid claim in such country covering such licensed product; (ii) the expiration of any period of data, regulatory, or market exclusivity, or supplemental protection certificates (other than patents) covering the licensed product in such country; and (iii) a period of ten years following the first commercial sale of the respective licensed product in such country.

Unless earlier terminated, the TG License Agreement will remain in effect on a licensed product-by-licensed product and country-by-country basis until the expiration of a defined royalty term for each licensed product and country. The Company may terminate the TG License Agreement if TG Therapeutics fails to initiate certain development activities with respect to the licensed product by a specified date or ceases active development of the licensed product for a specified period of time. In addition, the Company may terminate the TG License Agreement if TG Therapeutics or any of its affiliates or sublicensees challenges the validity of any patents controlled by the Company. Each of the Company and TG Therapeutics may terminate the TG License Agreement (i) for material breach by the other party and a failure to cure such breach within the time period specified in the TG License Agreement or (ii) due to the other party’s insolvency.

The Company assessed the TG License Agreement in accordance with ASC 606 and concluded that the promises in the TG License represent a transaction with a customer. The Company has concluded that the TG License Agreement contains the following promises: (i) the license to develop, manufacture, and commercialize non-oncological applications of azer-cel, (ii) deliver to TG Therapeutics a single batch of released clinical trial material (“CTM”) for azer-cel, (iii) designation of TG Therapeutics as the party with which Imugene must enter into a clinical supply agreement, and (iv) joint steering committee (“JSC”) participation. The designation of TG Therapeutics to Imugene and JSC participation were determined to be immaterial promises as the time commitment and related costs associated with performance are expected to be inconsequential to the total consideration in the contract. Accordingly, the Company concluded that the promise of the license and single batch of CTM are the two performance obligations.

The Company concluded the TG License Agreement represents functional intellectual property in accordance with ASC 606 as the Company will not be providing any additional services to TG Therapeutics outside of the right to use the licensed intellectual property and supply of CTM. During the three months ended March 31, 2024, the Company recognized revenue under the TG License Agreement of $7.0 million. Deferred revenue related to the TG License Agreement amounted to $0.9 million and a contract asset related to the TG License Agreement amounted to $1.4 million as of March 31, 2024.

Sale of Azer-cel CAR T Platform to Imugene for Cancer

On August 15, 2023, the Company entered into the Imugene Purchase Agreement. Pursuant to and simultaneously with the execution of the Imugene Purchase Agreement, on August 15, 2023 (the “Closing Date”), Imugene US acquired the Company’s manufacturing infrastructure used in the development and manufacture of azer-cel, including assuming the lease to the Company’s manufacturing facility and certain contracts of the Company with respect to the Company’s manufacturing facility, and related equipment, supplies, azer-cel clinical trial inventory and other assets related to the Company’s CAR T cell therapy platform. As part of the Imugene Purchase Agreement, Imugene US hired a number of employees of the Company who were associated with the Company’s historical CAR T cell therapy operations.

In consideration for the assets acquired under the Imugene Purchase Agreement, Imugene US assumed certain liabilities of the Company, paid the Company $8 million in cash, and issued to the Company the Imugene Convertible Note in an aggregate principal amount of $13 million. The Imugene Convertible Note is non-interest bearing and matures on the Maturity Date. On the Maturity Date, the Imugene Convertible Note will be redeemed with cash, converted into ordinary shares of Imugene Limited at a conversion price based on the 10-day VWAP of Imugene Limited’s ordinary shares prior to the date of conversion, or partially redeemed with cash and partially converted into shares, at Imugene’s discretion.

Additionally, the Company and Imugene US entered into a license agreement (the “Imugene License Agreement”) on the Closing Date, pursuant to which the Company granted Imugene US certain exclusive and non-exclusive license rights to develop, manufacture, and commercialize oncological applications of the Company’s allogeneic CAR T therapy, azer-cel, and up to three additional research product candidates directed to targets that Imugene US may nominate prior to the fifth anniversary of the effective date of the Imugene License Agreement, pursuant to the terms of the Imugene License Agreement.

20


 

In addition, under the Imugene License Agreement, the Company is eligible to receive milestone payments of up to an aggregate of $206 million for azer-cel, inclusive of a payment of $8 million in cash and equity upon successful completion of the Phase 1b dosing in the CAR T relapsed large B cell lymphoma (“LBCL”) patient population. For azer-cel, the Company is eligible to receive double-digit royalties on net sales. For up to three additional research programs to be developed by Imugene, the Company is eligible for up to $145 million in milestone payments and, if licensed products are approved and sold, tiered royalties ranging from the mid-single digit to low-double digit percentages on net sales of such licensed products. In addition, the Company is eligible to receive mid-single digit percentage-based fees for certain change of control transactions involving Imugene and for partnering transactions involving a licensed product. Imugene’s obligation to pay royalties to the Company expires on a country-by-country and licensed product-by-licensed product basis, upon the latest to occur of certain events related to expiration of patents, regulatory exclusivity or a period of ten years following the first commercial sale of the respective licensed product.

Unless earlier terminated, the Imugene License Agreement will remain in effect on a licensed product-by-licensed product and country-by-country basis until the expiration of a defined royalty term for each licensed product and country. The Company may terminate the entire Imugene License Agreement due to a challenge to its patents brought by Imugene and a breach by Imugene in any material respect of the Imugene License Agreement, the Imugene Purchase Agreement or any related transaction documents. The Company may also terminate the Imugene License Agreement with respect to azer-cel if Imugene fails to initiate certain development activities with respect to azer-cel by a specified date, if Imugene fails to expend certain amounts on the development of azer-cel or if Imugene ceases active development of azer-cel for a specified period of time. Either party may terminate the License Agreement (i) for material breach by the other party and a failure to cure such breach within the time period specified in the agreement or (ii) due to the other party’s insolvency.

The Company assessed the Imugene License Agreement in accordance with ASC 606 and concluded that the promises in the Imugene License Agreement represent a transaction with a customer. The Company has concluded that the Imugene License Agreement contains the following promises: (i) the license to develop, manufacture, and commercialize oncological applications of the azer-cel and up to three additional research product candidates and (ii) JSC participation. The JSC participation was determined to be an immaterial promise as the time commitment and related cost associated with performance of JSC participation is expected to be inconsequential to the total consideration in the contract. Accordingly, the Company concluded that the promise of the license is a single performance obligation.

The Company concluded the Imugene License Agreement represents functional intellectual property in accordance with ASC 606 given the Company will not be providing any additional services to Imugene outside of the right to use the licensed intellectual property. As of March 31, 2024, management has constrained all variable consideration related to milestone payments in the Imugene License Agreement given the level of uncertainty associated with achievement of the milestone payments. Accordingly, no revenue was recognized under the Imugene License Agreement during the three months ended March 31, 2024, and 2023.

Collaboration and License Agreement with Novartis

On June 14, 2022, the Company entered into a collaboration and license agreement (the “Novartis Agreement”) with Novartis Pharma AG (“Novartis”), which became effective on June 15, 2022 (the “Novartis Effective Date”), to collaborate to discover and develop in vivo gene editing products incorporating the Company’s custom ARCUS nucleases for the purpose of seeking to research and develop potential treatments for certain diseases (collectively referred to as licensed products). Any initial licensed products under the Novartis Agreement will be developed for the potential treatment of certain hemoglobinopathies, including sickle cell disease and beta thalassemia.

Pursuant to the terms of the Novartis Agreement, the Company will develop an ARCUS nuclease and conduct in vitro characterization for the licensed products, with Novartis then assuming responsibility for all subsequent development, manufacturing and commercialization activities. Novartis will receive an exclusive license for and be required to use commercially reasonable efforts to conduct all subsequent research, development, manufacture and commercialization activities with respect to the licensed products. The Company will initially develop a single, custom ARCUS nuclease for a defined “safe harbor” target site for insertion of specified therapeutic payloads in a patient’s genome (the “Initial Nuclease”) for Novartis to further develop as a potential in vivo treatment option for certain hemoglobinopathies, including sickle cell disease and beta thalassemia. Pursuant to the terms of the Novartis Agreement, Novartis may elect, subject to payment of a fee to the Company, to replace licensed products based on the Initial Nuclease with licensed products based on a second custom ARCUS nuclease the Company designs for gene editing of a specified human gene target associated with hemoglobinopathies (the “Replacement Nuclease”). Additionally, Novartis has the option, upon payment of a fee to the Company for each exercise of the option, to include licensed products utilizing the Initial Nuclease for insertion of up to three additional specified therapeutic payloads at the “safe harbor” target site, each intended to treat a particular genetic disease. The exercise period for such option ends on the earlier of (a) the fourth anniversary of the Novartis Effective Date and (b) the replacement of the Initial Nuclease with the Replacement Nuclease as described above.

21


 

In July 2022, the Company received a $50.0 million upfront cash payment under the Novartis Agreement. Additionally, on the Novartis Effective Date, Novartis made an equity investment in the Company’s common stock pursuant to a stock purchase agreement (the “Novartis Stock Purchase Agreement”) pursuant to which, on the Novartis Effective Date, the Company issued and sold to Novartis 413,581 shares of the Company’s common stock (the “Novartis Shares”) in a private placement transaction for an aggregate purchase price of $25.0 million, or approximately $60.30 per share. The price per share of the Company’s common stock under the Novartis Stock Purchase Agreement represented a 20% premium over the VWAP of the Company’s common stock over the 10 trading days preceding the execution date of the Novartis Stock Purchase Agreement. Management concluded that the Novartis Stock Purchase Agreement was to be combined with the Novartis Agreement for accounting purposes. Of the total $75.0 million upfront compensation, the Company applied equity accounting guidance to measure the $11.6 million recorded in equity upon the issuance of the Novartis Shares, and $63.4 million was identified as transaction price allocated to the revenue arrangement.

Pursuant to the Novartis Stock Purchase Agreement, subject to certain exceptions, Novartis may not sell the Novartis Shares without the Company’s approval for a period of two years following the Novartis Effective Date. In addition, for a period of two years following the Novartis Effective Date, Novartis and its affiliates may not (a) effect or otherwise participate in, directly or indirectly, any acquisition of any of our securities or material assets, any tender offer or exchange offer, merger or other business combination or change of control involving the Company, any recapitalization, restructuring, liquidation, dissolution or other extraordinary transaction with respect to the Company, or any solicitation of proxies or consents to vote any of the Company’s securities or (b) act with any other person, or publicly disclose any intention, to do any of the foregoing. The Novartis Stock Purchase Agreement also contains customary representations, warranties, and covenants of both parties.

On the Novartis Effective Date, the Company and Novartis also entered into a registration rights agreement (the “Registration Rights Agreement”) pursuant to which the Company has agreed, within the time periods specified in the Registration Rights Agreement, to register the resale of the Novartis Shares on a registration statement to be filed with the SEC. The Registration Rights Agreement contains customary indemnification provisions, and all registration rights terminate in their entirety effective on the first date on which there cease to be any Registrable Securities (as defined in the Registration Rights Agreement) outstanding.

The Company will also be eligible to receive milestone payments of up to an aggregate of approximately $1.4 billion as well as certain research funding. If licensed products resulting from the collaboration are approved and sold, the Company will also be entitled to receive tiered royalties ranging from the mid-single digit to low-double digit percentages on net sales of licensed products, subject to customary potential reductions. Novartis’s obligation to pay royalties to us expires on a country-by-country and licensed product-by-licensed product basis, upon the latest to occur of certain events related to expiration of patents, regulatory exclusivity or a period of ten years following the first commercial sale of the licensed product.

Unless earlier terminated, the Novartis Agreement will remain in effect on a licensed product-by-licensed product and country-by-country basis until the expiration of a defined royalty term for each licensed product and country. Novartis has the right to terminate the Novartis Agreement without cause by providing advance notice to the Company. Either party may terminate the Novartis Agreement for material breach by the other party and a failure to cure such breach within the time period specified in the Novartis Agreement. The Company may also terminate the Novartis Agreement in the event that Novartis brings a challenge to its patents.

The Company assessed the Novartis Agreement in accordance with ASC 606 and concluded that the promises in the agreement represent transactions with a customer. The Company has determined that the promises associated with the research and development activities for each of the targets are not distinct because they are all based on the ARCUS proprietary genome editing platform. The Company has concluded that the Novartis Agreement contains the following promises: (i) license of intellectual property, (ii) performance of research and development (“R&D”) services, and (iii) JSC participation. The Company determined that the license of intellectual property and R&D services were not distinct from each other, as the license and R&D services are highly interdependent upon one another. The JSC participation was determined to be an immaterial promise as the time commitment and related cost associated with performance of JSC participation is expected to be inconsequential to the total consideration in the contract. As such, the Company determined that these promises should be combined into a single performance obligation.

The Company recognizes revenue from the $50.0 million upfront cash payment, $13.4 million allocated to the transaction price from the Novartis Stock Purchase Agreement, and variable consideration on an input method in the form of research effort relative to expected research effort at the completion of the performance obligation, which is based on the actual hours of research work performed relative to expected hours of research work to be incurred in the future to satisfy the performance obligation. Management will evaluate and adjust the total expected research effort for the performance obligation on a quarterly basis based upon actual research hours incurred to date relative to research hour forecasts. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation.

During the three months ended March 31, 2024, and 2023, the Company recognized revenue under the Novartis Agreement of $4.5 million and $5.9 million, respectively. Deferred revenue related to the Novartis Agreement amounted to $28.1 million and $32.4

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million as of March 31, 2024 and December 31, 2023, respectively, of which $1.3 million and $7.4 million, respectively, was included in current liabilities within the condensed balance sheets.

Development and License Agreement with Prevail

On November 19, 2020, the Company entered into a development and license agreement with Eli Lilly and Company (“Lilly”) to collaborate to discover and develop in vivo gene editing products incorporating the Company’s ARCUS nucleases to utilize ARCUS for the research and development of potential in vivo therapies for genetic disorders, which was subsequently assigned to Prevail Therapeutics Inc., a wholly-owned subsidiary of Eli Lilly and Company (“Prevail”), effective November 1, 2022 (the “Original Prevail Agreement”).

On June 30, 2023, the Company entered into an amended and restated development and license agreement (the “Prevail Agreement”) with Prevail. The Prevail Agreement amended and restated the Original Prevail Agreement. Pursuant to the terms of the Prevail Agreement, Prevail and the Company continued to collaborate on developing the Company’s ARCUS nucleases for the research and development of potential in vivo therapies for genetic disorders, including Duchenne muscular dystrophy, a liver-directed target, and a central nervous system directed target. Pursuant to the Prevail Agreement, manufacturing initial clinical trial material for the first licensed product, which was previously the Company’s responsibility to conduct at Prevail’s expense, instead became Prevail’s responsibility at Prevail’s expense. Prevail continued to be responsible for, and was required to use commercially reasonable efforts with respect to, conducting clinical development and commercialization activities for licensed products resulting from the collaboration. Prevail also retained the right to nominate up to three additional gene targets for genetic disorders over the initial nomination period of four years.

On April 11, 2024, the Company received written notice from Prevail of its termination of the Prevail Agreement. Prevail’s notice informed the Company that Prevail was exercising its right pursuant to Section 15.3.2 of the Prevail Agreement to terminate the Prevail Agreement in its entirety without cause upon 90 days’ prior written notice to the Company. The Company subsequently exercised its rights to the return of the three programs. The termination will be effective on July 10, 2024.

In connection with the closing of the Original Prevail Agreement on January 6, 2021, the Company received an upfront cash payment of $100.0 million. Under the Prevail Agreement, the Company was also eligible to receive milestone payments of up to an aggregate of $390 million to $395 million per licensed product, a decrease from $420 million as provided in the Original Prevail Agreement, as well as nomination fees for additional and replacement targets and certain research funding. The terms of potential nomination fees for additional targets and royalties on worldwide net sales of licensed products for which the Company could have become eligible, as well as the terms of the Company’s right to elect to co-fund the clinical development of one licensed product under the Original Prevail Agreement, were not modified by the terms of the Prevail Agreement. If licensed products resulting from the collaboration had been approved and sold, the Company would also have been entitled to receive tiered royalties ranging from the mid-single digit percentages to the low-teens percentages on world-wide net sales of the licensed products, subject to customary potential reductions. Prevail’s obligation to pay royalties to the Company would have expired on a country-by-country and licensed product-by-licensed product basis, upon the latest to occur of certain events related to expiration of patents, regulatory exclusivity or a period of ten years following first commercial sale of the licensed product. Simultaneously with the entry into the Original Prevail Agreement, the Company and Lilly entered into a Share Purchase Agreement (the “Lilly Share Purchase Agreement”), pursuant to which Lilly purchased 125,406 shares of the Company’s common stock for a purchase price of $35.0 million. Management concluded that the Lilly Share Purchase Agreement was to be combined with the Original Prevail Agreement for accounting purposes. Of the total $135.0 million upfront compensation, the Company applied equity accounting guidance to measure the $27.7 million recorded in equity upon the issuance of the shares, and $107.3 million was identified as the transaction price allocated to the revenue arrangement.

The Company assessed this arrangement in accordance with ASC 606 and concluded that the promises in the agreement represent transactions with a customer. The Company has determined that the promises associated with the research and development activities for each of the targets are not distinct because they are all based on the ARCUS proprietary genome editing platform. The Company concluded that the agreement with Prevail contained the following promises: (i) license of intellectual property; (ii) performance of R&D services, (iii) JSC participation, and (iv) regulatory responsibilities. The Company determined that the license of intellectual property, R&D services, and regulatory responsibilities were not distinct from each other, as the license, R&D services, and regulatory responsibilities are highly interdependent upon one another. The JSC participation was determined to be an immaterial promise as the time commitment and related cost associated with performance of JSC participation is expected to be inconsequential to the total consideration in the contract. As such, the Company determined that these promises should be combined into a single performance obligation.

The Company recognized revenue from the $100.0 million upfront cash payment, $7.3 million allocated to the transaction price from the Lilly Share Purchase Agreement, and variable consideration on an input method in the form of research effort relative to expected research effort at the completion of the performance obligation, which was based on the actual time of R&D activities performed

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relative to expected time to be incurred in the future to satisfy the performance obligation. Management evaluated and adjusted the total expected research effort for the performance obligation on a quarterly basis based upon actual research progress to date relative to research progress forecasts. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation.

During the three months ended March 31, 2024 and 2023, the Company recognized revenue under the Prevail Agreement of $4.5 million and $2.9 million, respectively. Deferred revenue related to the Prevail Agreement amounted to $48.2 million and $52.7 million as of March 31, 2024 and December 31, 2023, respectively, of which $0.2