10-Q 1 gbio-20220930x10q.htm 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2022

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: 001-39319

GENERATION BIO CO.

(Exact name of registrant as specified in its charter)

Delaware

    

81-4301284

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer
Identification Number)

301 Binney Street
Cambridge, Massachusetts

 

02142

(Address of principal executive offices)

 

(Zip Code)

(617) 655-7500

(Registrant’s telephone number, including area code)

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, $0.0001 Par Value

 

GBIO

 

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, 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 October 31, 2022 there were 59,422,697 shares of Common Stock, $0.0001 par value per share, outstanding.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or this Quarterly Report, of Generation Bio Co. contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report include, among other things, statements about:

the initiation, timing, progress and results of our research and development programs and preclinical studies and clinical trials;
our estimates regarding expenses, future revenue, capital requirements, need for additional financing and the period over which we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements;
our ability to find one or more third parties to assume our lease or sublease the property in Waltham, MA;
the potential advantages of our non-viral genetic medicine platform;
our plans to develop and, if approved, subsequently commercialize any product candidates we may develop;
the timing of and our ability to submit applications and obtain and maintain regulatory approvals for any product candidates we may develop;
our estimates regarding the potential addressable patient populations for our programs;
our commercialization, marketing and manufacturing capabilities and strategy;
our expectations regarding our ability to obtain and maintain intellectual property protection;
our intellectual property position;
our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
the impact of the COVID-19 pandemic and our response to the pandemic;
the impact of government laws and regulations;
our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available;
developments and expectations regarding developments and projections relating to our competitors and our industry; and
our ability to maintain and establish collaborations or obtain additional funding.

2

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and stockholders should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report, particularly in the “Risk Factors” section in this Quarterly Report and our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a competitive and rapidly changing 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. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures, or investments we may make or enter into.

Stockholders should read this Quarterly Report and the documents that we file with the SEC with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report are made as of the date of this Quarterly Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Except where the context otherwise requires or where otherwise indicated, the terms “we,” “us,” “our,” “our company,” “the company,” and “our business” in this Quarterly Report refer to Generation Bio Co. and its consolidated subsidiary.

3

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

Generation Bio Co.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

September 30, 2022

December 31, 2021

Assets

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

134,487

$

375,145

Marketable securities

 

166,682

 

Tenant receivable

 

395

 

Prepaid expenses and other current assets

 

8,994

 

4,041

Total current assets

 

310,558

 

379,186

Property and equipment, net

 

23,435

 

25,886

Operating lease right-of-use assets

61,126

65,143

Restricted cash

 

5,692

 

5,692

Deferred offering costs

 

434

 

461

Other long-term assets

 

1,554

 

403

Total assets

$

402,799

$

476,771

Liabilities and Stockholders’ Equity

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

1,693

$

2,023

Accrued expenses and other current liabilities

 

8,995

 

12,177

Operating lease liability

6,630

4,608

Total current liabilities

 

17,318

 

18,808

Operating lease liability, net of current portion

76,732

76,217

Total liabilities

 

94,050

 

95,025

Commitments and contingencies (Note 8)

 

  

 

  

Stockholders’ equity:

 

 

Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at September 30, 2022 and December 31, 2021

 

 

Common stock, $0.0001 par value; 150,000,000 shares authorized at September 30, 2022 and December 31, 2021; 59,275,169 and 56,980,701 shares issued at September 30, 2022 and December 31, 2021, respectively; 59,275,169 and 56,969,618 shares outstanding at September 30, 2022 and December 31, 2021, respectively

 

6

 

6

Additional paid-in capital

 

721,405

 

689,866

Accumulated other comprehensive income

 

(302)

 

Accumulated deficit

 

(412,360)

 

(308,126)

Total stockholders’ equity

 

308,749

 

381,746

Total liabilities and stockholders’ equity

$

402,799

$

476,771

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

5

Generation Bio Co.

Condensed Consolidated 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, 

2022

    

2021

    

2022

    

2021

Operating expenses:

  

 

  

 

  

 

  

Research and development

$

21,192

$

21,991

$

75,111

$

63,400

General and administrative

 

11,477

 

9,667

 

31,383

 

24,755

Total operating expenses

 

32,669

 

31,658

 

106,494

 

88,155

Loss from operations

 

(32,669)

 

(31,658)

 

(106,494)

 

(88,155)

Other income:

 

  

 

 

  

 

  

Other income (expense) and interest income, net

 

1,363

 

(197)

 

2,260

 

(53)

Net loss and net loss attributable to common stockholders

$

(31,306)

$

(31,855)

$

(104,234)

$

(88,208)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.53)

$

(0.56)

$

(1.81)

$

(1.57)

Weighted average common shares outstanding, basic and diluted

 

58,872,334

 

56,629,193

 

57,679,635

 

56,108,492

Comprehensive loss:

 

  

 

  

 

  

 

  

Net loss

$

(31,306)

$

(31,855)

$

(104,234)

$

(88,208)

Other comprehensive loss:

 

  

 

  

 

  

 

  

Unrealized gains (losses) on marketable securities

 

37

 

(3)

 

(302)

 

(8)

Comprehensive loss

$

(31,269)

$

(31,858)

$

(104,536)

$

(88,216)

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

6

Generation Bio Co.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)

Accumulated

Additional

Other

Total

Common Stock

 Paid-in

Comprehensive

Accumulated

Stockholders’

Shares

Amount

Capital

(Loss) Income

Deficit

Equity

Three Months Ended September 30, 2022

Balances at June 30, 2022

    

57,597,141

$

6

$

706,261

$

(339)

$

(381,054)

$

324,874

Issuance of common stock from public ATM offering, net of commissions and offering costs of $315

1,379,887

9,617

9,617

Issuance of common stock upon exercise of stock options

 

15,026

 

 

58

 

 

 

58

Vesting of restricted common stock

 

280,404

 

 

(394)

 

 

 

(394)

Issuance of common stock under other equity plans

2,711

15

15

Stock-based compensation expense

 

 

 

5,848

 

 

 

5,848

Unrealized gains on marketable securities

 

 

 

 

37

 

 

37

Net loss

 

 

 

 

 

(31,306)

 

(31,306)

Balances at September 30, 2022

 

59,275,169

$

6

$

721,405

$

(302)

$

(412,360)

$

308,749

Accumulated

Additional

Other

Total

Common Stock

 Paid-in

Comprehensive

Accumulated

Stockholders’

Shares

Amount

Capital

Income (Loss)

Deficit

Equity

Three Months Ended September 30, 2021

Balances at June 30, 2021

    

56,431,513

    

$

6

    

$

678,720

    

$

4

    

$

(245,328)

    

$

433,402

Issuance of common stock upon exercise of stock options

 

145,646

 

 

697

 

 

 

697

Vesting of restricted common stock

 

155,306

 

 

 

 

 

Stock-based compensation expense

 

 

 

4,970

 

 

 

4,970

Unrealized losses on marketable securities

 

 

 

 

(4)

 

 

(4)

Net loss

 

 

 

 

 

(31,855)

 

(31,855)

Balances at September 30, 2021

 

56,732,465

$

6

$

684,387

$

$

(277,183)

$

407,210

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

7

Generation Bio Co.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders’

Shares

Amount

Capital

(Loss)

Deficit

Equity

 

Nine Months Ended September 30, 2022

Balances at December 31, 2021

    

56,969,618

    

$

6

    

$

689,866

    

$

    

$

(308,126)

    

$

381,746

Issuance of common stock from public ATM offering, net of commissions and offering costs of $404

1,795,524

 

12,338

 

 

12,338

Issuance of common stock upon exercise of stock options

 

147,400

 

 

611

 

 

 

611

Vesting of restricted common stock

 

294,767

 

 

(394)

 

 

 

(394)

Issuance of common stock under other equity plans

67,860

379

379

Stock-based compensation expense

 

 

 

18,605

 

 

 

18,605

Unrealized losses on marketable securities

 

 

 

 

(302)

 

 

(302)

Net loss

 

 

 

 

 

(104,234)

 

(104,234)

Balances at September 30, 2022

 

59,275,169

$

6

$

721,405

$

(302)

$

(412,360)

$

308,749

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders’

Shares

Amount

Capital

Income (Loss)

Deficit

Equity

Nine Months Ended September 30, 2021

Balances at December 31, 2020

    

46,291,877

    

$

5

    

$

456,974

    

$

9

    

$

(188,975)

    

$

268,013

Issuance of common stock upon initial public offering, net of issuance costs of $590

9,200,000

1

211,285

211,286

Issuance of common stock upon exercise of stock options

 

689,166

 

 

2,947

 

 

 

2,947

Vesting of restricted common stock

 

535,911

 

 

 

 

 

Issuance of common stock under other equity plans

15,511

355

355

Stock-based compensation expense

 

 

 

12,826

 

 

 

12,826

Unrealized losses on marketable securities

 

 

 

 

(9)

 

 

(9)

Net loss

 

 

 

 

 

(88,208)

 

(88,208)

Balances at September 30, 2021

 

56,732,465

$

6

$

684,387

$

$

(277,183)

$

407,210

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

8

Generation Bio Co.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

    

Nine Months Ended September 30, 

2022

2021

Cash flows from operating activities:

Net loss

$

(104,234)

$

(88,208)

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

 

  

 

  

Stock-based compensation expense

 

18,605

 

12,826

Depreciation and amortization expense

 

3,784

 

3,367

Amortization (accretion) of premium (discount) on marketable securities, net

 

(984)

 

514

Loss on sale of property and equipment

28

223

Loss on impairment of property and equipment

5,395

Changes in operating assets and liabilities:

 

 

  

Tenant receivable

 

(395)

 

Prepaid expenses and other current assets

 

(4,939)

 

504

Operating lease right-of-use assets

4,017

2,157

Other noncurrent assets

 

(1,151)

 

(133)

Accounts payable

 

(444)

 

253

Accrued expenses and other current liabilities

 

(1,663)

 

523

Operating lease liability

2,536

(3,045)

Net cash used in operating activities

 

(79,445)

 

(71,019)

Cash flows from investing activities:

 

  

 

  

Purchases of property and equipment

 

(8,119)

 

(3,123)

Proceeds from sale of property and equipment

105

Purchases of marketable securities

 

(221,000)

 

Maturities of marketable securities

 

55,000

 

188,900

Net cash (used in) provided by investing activities

 

(174,119)

 

185,882

Cash flows from financing activities:

 

  

 

  

Proceeds from public offering of common stock, net of underwriting discounts and commissions

 

 

211,876

Payment of offering costs

(50)

(942)

Proceeds from issuance of common stock from public ATM offering, net of commissions and offering costs

12,360

Proceeds from exercise of stock options and other types of equity, net

 

990

 

3,302

Tax withholding payments related to net share settlements of restricted stock units

(394)

Net cash provided by financing activities

 

12,906

 

214,236

Net (decrease) increase in cash, cash equivalents and restricted cash

 

(240,658)

 

329,099

Cash, cash equivalents and restricted cash at beginning of period

 

380,837

 

64,940

Cash, cash equivalents and restricted cash at end of period

$

140,179

$

394,039

Supplemental disclosure of noncash investing and financing information:

 

  

 

  

Purchases of property and equipment included in accounts payable and accrued expenses

$

165

$

249

Unrealized losses on marketable securities

$

(302)

$

(8)

Offering costs included in accounts payable and accrued expenses

$

$

80

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

9

1. Nature of the Business and Basis of Presentation

Generation Bio Co., or Generation Bio, was incorporated on October 21, 2016 as Torus Therapeutics, Inc. and subsequently changed its name to Generation Bio Co. Generation Bio Co. and its consolidated subsidiary, or the company, we, our or us, are innovating genetic medicines to provide durable, redosable treatments for potentially hundreds of millions of patients living with rare and prevalent diseases. Our non-viral genetic medicines platform incorporates our high-capacity DNA construct called closed-ended DNA, or ceDNA; our cell-targeted lipid nanoparticle delivery system, or ctLNP; and our highly scalable capsid-free manufacturing process that uses our proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. Using our approach, we are developing novel genetic medicines to provide targeted delivery of genetic payloads that include large and multiple genes to a range of cell types across a broad array of diseases. We are also engineering our genetic medicines to be redosable, which may enable individualized patient titration to reach the desired therapeutic expression and to maintain efficacy throughout a patient’s life. We are headquartered in Cambridge, Massachusetts.

We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the ability to establish clinical- and commercial-scale manufacturing processes and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization of a product. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if our development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales.

In June 2020, we completed our initial public offering, or IPO, pursuant to which we issued and sold 12,105,263 shares of our common stock, including 1,578,947 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares resulting in net proceeds of $210.7 million, after deducting underwriting discounts and commissions and other offering expenses. Upon the closing of the IPO, all of our outstanding convertible preferred stock automatically converted into shares of common stock. In January 2021, we issued and sold 9,200,000 shares of our common stock, including 1,200,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, in a follow-on public offering, resulting in net proceeds of $211.3 million after deducting underwriting discounts and commissions and other offering expenses.

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, we have funded our operations with proceeds from the sale of instruments convertible into convertible preferred stock (which converted into convertible preferred stock in 2017), the sales of convertible preferred stock (which converted into common stock in 2020), and most recently, the sales of common stock in underwritten public offerings. We have incurred recurring losses, including net losses of $104.2 million for the nine months ended September 30, 2022 and $88.2 million for the nine months ended September 30, 2021. As of September 30, 2022, we had an accumulated deficit of $412.4 million. We expect to continue to generate operating losses in the foreseeable future. As of November 3, 2022, the issuance date of these condensed consolidated financial statements, we expect that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements for at least 12 months.

We will need to obtain additional funding through public or private equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements. We may not be able to obtain financing on acceptable terms, or at all, and we may not be able to enter into collaborative or strategic alliances or licensing arrangements. The terms of any financing may adversely affect the holdings or the rights of our stockholders. Arrangements with collaborators or others may require us to relinquish rights to certain of our technologies or programs. If we are unable to obtain funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, pipeline expansion or commercialization efforts, which could adversely affect our business prospects. Although management will continue to pursue these plans, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations when needed or at all.

10

The accompanying condensed consolidated financial statements reflect the operations of Generation Bio and our wholly owned subsidiary, Generation Bio Securities Corporation. Intercompany balances and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America, or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB.

2. Summary of Significant Accounting Policies

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, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses and stock-based compensation expense. We base our estimates on historical experience, known trends and other market-specific or other relevant factors that we believe to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.

Unaudited interim financial information

The condensed consolidated balance sheet as of December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC, for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with our audited financial statements included in our Annual Report on Form 10-K that was most recently filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair presentation of our financial position as of September 30, 2022, the results of operations for the three and nine months ended September 30, 2022 and 2021, and cash flows for the nine months ended September 30, 2022 and 2021 have been made. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022 or any other period.

Our significant accounting policies are described in Note 2 of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2021.

11

3. Marketable Securities and Fair Value Measurements

The following tables present our marketable securities by security type:

As of September 30, 2022

    

    

Gross

    

Gross

    

Amortized

Unrealized

Unrealized

Fair

(in thousands)

Cost

Gains

Losses

Value

Commercial paper

$

9,992

$

$

$

9,992

U.S. treasury securities

156,992

8

(310)

156,690

Totals

$

166,984

$

8

$

(310)

$

166,682

As of September 30, 2022, our marketable securities consisted of investments that mature within one year.

We did not have marketable securities as of December 31, 2021.

The following tables present our assets that are measured at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques that we utilized to determine such fair value:

    

Fair Value Measurements at September 30, 2022 Using:

(in thousands)

Level 1

Level 2

Level 3

Total

Cash equivalents:

 

  

 

  

 

  

 

  

Money market funds

$

1,285

$

$

$

1,285

U.S. treasury securities

32,841

32,841

Marketable securities:

 

  

 

  

 

  

 

  

Commercial paper

 

 

9,992

 

 

9,992

U.S. treasury securities

 

 

156,690

 

 

156,690

Totals

$

1,285

$

199,523

$

$

200,808

    

Fair Value Measurements at December 31, 2021 Using:

(in thousands)

    

Level 1

    

Level 2

    

Level 3

    

Total

Cash equivalents:

  

 

  

 

  

 

  

Money market funds

$

259,609

$

$

$

259,609

Money market funds were valued based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. Our marketable securities, which as of September 30, 2022 have consisted of commercial paper and U.S. treasury securities, were valued using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.

12

4. Property and equipment, net

Property and equipment, net consisted of the following:

September 30, 

December 31,

(in thousands)

2022

2021

Laboratory equipment

$

13,765

$

12,826

Computer equipment and software

 

1,193

 

1,128

Furniture and fixtures

 

1,134

 

826

Leasehold improvements

 

20,751

 

17,374

Construction in progress

 

94

 

3,748

36,937

35,902

Less: Accumulated depreciation and amortization

(13,502)

(10,016)

Total

$

23,435

$

25,886

Depreciation and amortization expense for the three and nine months ended September 30, 2022 was $1.4 million and $3.8 million, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2021 was $1.2 million and $3.4 million, respectively.

In July 2021, we entered into a lease agreement to build out a current Good Manufacturing Practice-, or cGMP-, compliant manufacturing facility in Waltham, Massachusetts in order to scale ceDNA manufacturing utilizing RES for clinical and initial commercial supply. Following additional process development of RES, we achieved a significant increase in scale, while maintaining high productivity and ceDNA purity. RES production requires a much smaller manufacturing footprint than previously anticipated, and consequently, we are seeking one or more third parties to assume our lease or sublease the property. As a result, we recognized an impairment of $5.0 million related to the abandonment of leasehold improvements on our condensed consolidated statements of operations and comprehensive loss during the nine months ended September 30, 2022. We have performed an impairment assessment on other assets related to this abandonment of leasehold improvements and concluded that no additional impairment is necessary.

5. Accrued Expenses

Accrued expenses and other current liabilities consisted of the following:

September 30, 

December 31,

(in thousands)

    

2022

2021

Accrued employee compensation and benefits

$

6,405

$

7,579

Accrued external research and development expenses

 

1,000

 

2,091

Accrued professional fees

 

1,174

 

962

Property and equipment

46

869

Other

 

370

 

676

Total

$

8,995

$

12,177

6. Equity

As of September 30, 2022, our amended and restated certificate of incorporation authorizes us to issue 150,000,000 shares of common stock, par value $0.0001 per share, and 5,000,000 shares of preferred stock, par value $0.0001 per share, all of which preferred stock is undesignated.

13

In January 2021, we issued and sold 9,200,000 shares of our common stock, including 1,200,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, in a follow-on public offering, resulting in net proceeds of $211.3 million after deducting underwriting discounts and commissions and other offering expenses. In August 2021, we entered into an “at-the-market” sales agreement pursuant to which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $250.0 million. As of November 3, 2022, the issuance date of these condensed consolidated financial statements, we have issued and sold 1,795,524 shares of our common stock pursuant to this sales agreement resulting in net proceeds of $12.3 million.

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of our stockholders. Holders of common stock are not entitled to receive dividends, unless declared by the board of directors.

7. Stock-Based Compensation

Stock incentive plans

Our 2017 Stock Incentive Plan, or the 2017 Plan, provided for us to grant incentive stock options or nonstatutory stock options, restricted stock, restricted stock units and other equity awards to employees, non-employees, and directors. In January 2020, the number of shares of common stock authorized for issuance under the 2017 Plan was increased from 8,407,405 shares to 10,275,717 shares.

In May 2020, our board of directors adopted, and in June 2020, our stockholders approved, the 2020 Stock Incentive Plan, or the 2020 Plan, and, together with the 2017 Plan, the Plans, which became effective on June 11, 2020. The 2020 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The number of shares of common stock reserved for issuance under the 2020 Plan is the sum of (1) 2,547,698 shares; plus (2) the number of shares (up to a maximum of 7,173,014 shares) as was equal to the sum of (x) the number of shares of common stock reserved for issuance under the 2017 Plan that remained available for grant under the 2017 Plan on June 11, 2020 and (y) the number of shares of common stock subject to outstanding awards granted under the 2017 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right; plus (3) an annual increase, to be added on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2021 and continuing until, and including, the fiscal year ending December 31, 2030, equal to the lesser of (i) 4% of the number of shares of common stock outstanding on such date, and (ii) an amount determined by the board of directors. In January 2021 and 2022, the number of shares of common stock authorized for issuance under the 2020 Plan was increased from 10,275,717 shares to 12,154,517 shares and from 12,154,517 shares to 14,433,745 shares, respectively. Upon the effectiveness of the 2020 Plan, we ceased granting additional awards under the 2017 Plan.

The Plans are administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions on any award under the Plans are determined at the discretion of the board of directors, or its committee if so delegated. Stock options granted under the Plans with service-based vesting conditions generally vest over four years and expire after ten years. The exercise price for stock options granted is not less than the fair value of common stock as of the date of grant. Prior to our IPO, fair value of common stock was determined by the board of directors. Subsequent to our IPO, fair value of common stock is based on quoted market prices.

As of September 30, 2022, 675,968 shares remained available for future issuance under the 2020 Plan. Shares subject to outstanding awards granted under the Plans that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right will be available for future awards under the 2020 Plan.

Grant of stock options

During the nine months ended September 30, 2022, we granted service-based options to certain employees and directors for the purchase of 3,368,790 shares of common stock with a weighted average grant date fair value of $4.78 per share that vest over a weighted average period of approximately four years.

14

Restricted stock units

During the nine months ended September 30, 2022, we issued 1,660,884 restricted stock units with a fair value of $10.9 million that vest over a weighted average period of approximately 2.2 years.

Employee stock purchase plan

In May 2020, our board of directors adopted, and in June 2020, our stockholders approved, the 2020 Employee Stock Purchase Plan, or the 2020 ESPP, which became effective June 11, 2020. The 2020 ESPP is administered by our board of directors or by a committee appointed by the board of directors. The number of shares of common stock reserved for issuance under the 2020 ESPP automatically increases on the first day of each fiscal year, beginning with the fiscal year that commenced on January 1, 2021 and continuing for each fiscal year until, and including the fiscal year commencing on, January 1, 2030, in an amount equal to the lowest of (1) 1,302,157 shares of common stock, (2) 1% of the number of shares of common stock outstanding on such date, and (3) an amount determined by the board of directors. In January 2022, the number of shares of common stock authorized for issuance under the 2020 ESPP was increased from 950,931 shares to 1,520,738 shares. As of September 30, 2022, 1,414,371 shares remained available for issuance under the 2020 ESPP.

Stock-based compensation

Stock-based compensation expense was classified in the condensed consolidated statements of operations and comprehensive loss as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

(in thousands)

   

2022

    

2021

   

2022

    

2021

Research and development expenses

$

3,046

$

2,498

$

9,674

$

6,772

General and administrative expenses

 

2,802

 

2,472

 

8,931

 

6,054

Total

$

5,848

$

4,970

$

18,605

$

12,826

As of September 30, 2022, total unrecognized compensation cost related to unvested service-based stock options and restricted common stock was $49.7 million, with $43.0 million expected to be recognized over a weighted average period of 2.6 years and $6.7 million expected to be recognized over a weighted average period of 1.5 years, respectively. Additionally, as of September 30, 2022, we had unrecognized compensation cost related to unvested stock options with performance-based vesting conditions for which performance has not been deemed probable of $1.7 million.

8. Commitments and Contingencies

401(k) Plan

We have a defined-contribution plan under Section 401(k) of the Internal Revenue Code of 1986, as amended, or the 401(k) Plan. The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to contribute a portion of their annual compensation on a pre-tax and/or after-tax basis. In September 2020, we adopted a match program, beginning on January 1, 2021, for employee contributions to the 401(k) Plan up to a maximum of four percent of the employee’s salary, subject to the maximums established under the U.S. Internal Revenue Code of 1986, as amended.

Indemnification agreements

In the ordinary course of business, we may provide indemnification of varying scope and terms to vendors, lessors, contract research organizations, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, we have entered into indemnification agreements with members of our board of directors and our officers that will require us, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments we could be required to make under

15

these indemnification agreements is, in many cases, unlimited. We have not incurred any material costs as a result of such indemnifications and are not currently aware of any indemnification claims.

Legal proceedings

We, from time to time, may be party to litigation arising in the ordinary course of business. We were not subject to any material legal proceedings during the nine months ended September 30, 2022.

9. Net Loss per Share

We have generated a net loss in all periods presented, therefore the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. We excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated:

September 30, 

    

2022

   

2021

Unvested restricted common stock

 

 

145,567

Unvested restricted common stock units

1,170,433

14,760

Stock options to purchase common stock

 

8,786,200

 

6,071,008

Total

 

9,956,633

 

6,231,335

16

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations are meant to provide material information relevant to an assessment of the financial condition and results of operations of our company, including an evaluation of the amounts and uncertainties of cash flows from operations and from outside resources, so as to allow investors to better view our company from management’s perspective. It should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q, or Quarterly Report, and our consolidated financial statements and related notes appearing in our most recently filed Annual Report on Form 10-K, or Annual Report, with the Securities and Exchange Commission, or SEC. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report, in our Annual Report and in the other documents filed with the SEC, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

Overview

We are innovating genetic medicines to provide durable, redosable treatments for potentially hundreds of millions of patients living with rare and prevalent diseases. Our non-viral genetic medicine platform incorporates our high-capacity DNA construct called closed-ended DNA, or ceDNA; our cell-targeted lipid nanoparticle delivery system, or ctLNP; and our highly scalable capsid-free manufacturing process that uses our proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. Using our approach, we are developing novel genetic medicines to provide targeted delivery of genetic payloads that include large and multiple genes to a range of cell types across a broad array of diseases. We are also engineering our genetic medicines to be redosable, which may enable individualized patient titration to reach the desired level of therapeutic expression and to maintain efficacy throughout a patient’s life.

We are advancing a broad and expansive portfolio of programs, including programs for rare and prevalent diseases of the liver and retina. We are focused on diseases with significant unmet need for which our non-viral genetic medicine platform may substantially improve clinical efficacy relative to current gene therapy approaches. We are initially prioritizing rare monogenic diseases of the liver and retina, which are diseases that result from mutations in a single gene, that have well-established biomarkers and clear clinical and regulatory pathways. We are currently optimizing our ctLNPs to improve on-target biodistribution, which we believe will enable ligand-directed, selective delivery to hepatocytes and other cell types. We plan to expand our portfolio to include rare and prevalent diseases of the skeletal muscle, the central nervous system and oncology by developing discrete ctLNPs, each engineered to reach a different tissue.

In addition, we believe that our non-viral genetic medicine platform may be used to develop therapies that deliver antibody genes to direct the liver to produce antibody therapies from patients’ own cells for years at a time from a single dose in a process we refer to as endogenous therapeutic antibody production, or ETAP. We plan to advance ETAP programs across multiple therapeutic areas, including prevalent indications.

We also believe that our platform may be used to develop other therapeutic modalities and are exploring ways to apply our platform technologies. For example, we are conducting early research into the development of potential messenger RNA-, or mRNA-, based vaccines and ceDNA-based vaccines, in each case, using our proprietary ctLNPs for vaccines. We believe mRNA-ctLNP and ceDNA-ctLNP vaccines could meet or exceed the benchmark for efficacy and duration of current mRNA-LNP vaccines in use. In particular, we believe ceDNA-ctLNP vaccines could enable more durable antigen expression, and could be stored at ambient temperatures, potentially allowing for greater shelf stability than currently approved mRNA-LNP vaccines, which currently must be stored at very low temperatures, limiting distribution.

In July 2021, we entered into a lease agreement, or the Seyon Lease, to build out a current Good Manufacturing Practice-, or cGMP-, compliant manufacturing facility in Waltham, Massachusetts in order to scale ceDNA manufacturing utilizing RES for clinical and initial commercial supply. Following additional process development of RES, we achieved a significant increase in scale, while maintaining high productivity and ceDNA purity. RES production requires a much smaller manufacturing footprint than previously anticipated, and consequently, we are seeking one or more third parties to assume our lease or sublease the property. We have entered into an agreement with an external cleanroom facility at

17

which we expect to manufacture cGMP-compliant clinical and initial commercial supply of ceDNA using RES that will allow us to retain control over personnel, quality, infrastructure and process. Additionally, we may enter into agreements with contract manufacturing organizations, or CMOs, to provide further manufacturing capacity.

Since our inception in October 2016, we have focused substantially all of our resources on building our non-viral genetic medicine platform, establishing and protecting our intellectual property portfolio, conducting research and development activities, developing our manufacturing process, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. To date, we have funded our operations with proceeds from the sale of instruments convertible into convertible preferred stock (which converted into convertible preferred stock in 2017), the sales of convertible preferred stock (which converted into common stock in 2020) and, most recently, the sales of common stock in public offerings. In June 2020, we completed our initial public offering, or IPO, pursuant to which we issued and sold 12,105,263 shares of our common stock, including 1,578,947 shares sold by us pursuant to the full exercise of the underwriters’ option to purchase additional shares. We received net proceeds of $210.7 million, after deducting underwriting discounts and commissions and other offering expenses. In January 2021, we issued and sold 9,200,000 shares of our common stock, including 1,200,000 shares sold by us pursuant to the full exercise of the underwriters’ option to purchase additional shares, in a follow-on public offering, resulting in net proceeds of $211.3 million after deducting underwriting discounts and commissions and other offering expenses.

Historically, we have incurred significant operating losses. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more product candidates we may develop. For the nine months ended September 30, 2022 and 2021, we reported net losses of $104.2 million and $88.2 million, respectively. As of September 30, 2022, we had an accumulated deficit of $412.4 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

obtain, expand, maintain, defend and enforce our intellectual property portfolio;
continue our current research programs and conduct additional research programs;
expand the capabilities of our proprietary non-viral genetic medicine platform;
add operational, legal, compliance, financial and management information systems and personnel to support our research, product development, future commercialization efforts and operations as a public company;
develop our capabilities to manufacture and establish additional commercial manufacturing sources and secure supply chain capacity sufficient to provide necessary quantities of any product candidates we may develop for clinical or commercial use;
hire additional clinical, regulatory and scientific personnel;
advance any product candidates we identify into preclinical and clinical development;
seek marketing approvals for any product candidates that successfully complete clinical trials; and
ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for any product candidates we may develop. If we obtain regulatory approval for any product candidates we may develop, we expect to incur significant expenses related to developing our commercial capability to

18

support product sales, marketing and distribution. Further, we expect to continue to incur additional costs associated with operating as a public company.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements when needed or on terms acceptable to us, we would be required to delay, limit, reduce or terminate our product development or future commercialization of one or more of our product candidates.

Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditures into 2025. We have based our estimates as to how long we expect we will be able to fund our operations on assumptions that may prove to be wrong. We could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing, which may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. See “—Liquidity and Capital Resources.”

COVID-19

The COVID-19 pandemic continues to present a public health and economic challenge around the world. The length of time and full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, subject to change and difficult to predict. We, our CMOs, and our contract research organizations, or CROs, experienced temporary reductions in the capacity to undertake research-scale production and to execute some preclinical studies. While these operations have since normalized, we, together with our CMOs and CROs, are closely monitoring the impact of the COVID-19 pandemic on these operations. In addition, shortages, delays and governmental restrictions arising from the COVID-19 pandemic have disrupted and may continue to disrupt global supply chains and our vendors’ ability to procure items, such as raw materials, that are essential for the manufacturing of our product candidates. We have taken steps to monitor and strengthen our supply chain to maintain an uninterrupted supply of our critical products and services.

We continue to closely monitor the ongoing impact and effects of the COVID-19 pandemic on our employees and our other business operations. In an effort to provide a safe work environment for our employees, we have maintained our increased cadence of sanitization of our office and lab facilities and provision of personal protective equipment for our employees present in our office and lab facilities. Moreover, in accordance with updated federal and state guidelines, we have relaxed some of our COVID-19 related restrictions. For example, we are permitting on-site presence in our office and lab facilities. Additionally, we implemented a company policy requiring COVID-19 vaccinations for all employees, with certain limited exceptions.

We expect to continue to take actions as may be required or recommended by government authorities or as we determine are in the best interests of our employees and other business partners in light of the pandemic.

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Components of Our Results of Operations

Operating expenses

Research and development expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our programs, which include:

personnel-related costs, including salaries, benefits and stock-based compensation expense, for employees engaged in research and development functions;
expenses incurred in connection with our research programs, including under agreements with third parties, such as consultants, contractors and CROs, and regulatory agency fees;
the cost of developing and scaling our manufacturing process and capabilities and manufacturing drug substance and drug product for use in our research and preclinical studies, including under agreements with third parties, such as consultants, contractors and CMOs;
laboratory supplies and research materials;
facilities, depreciation and amortization and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance; and
payments made under third-party licensing agreements.

We expense research and development costs as incurred. Advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

Our external research and development expenses consist of costs that include fees and other costs paid to consultants, contractors, CMOs and CROs in connection with our research, preclinical and manufacturing activities. We do not allocate our research and development costs to specific programs because costs are deployed across multiple programs and our platform and, as such, are not separately classified. We expect that our research and development expenses will increase substantially as we advance our programs into clinical development and expand our discovery, research and preclinical activities in the near term and in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any product candidates we may develop. The successful development of any of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with product development, including the following:

the timing and progress of preclinical studies, including investigational new drug, or IND , -enabling studies;
the number and scope of preclinical and clinical programs we decide to pursue;
raising additional funds necessary to complete preclinical and clinical development of our product candidates;
the timing of the submission and acceptance of IND applications or comparable foreign applications that allow commencement of future clinical trials for our product candidates;
the successful initiation, enrollment and completion of clinical trials, including under Good Clinical Practices;

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our ability to achieve positive results from our future clinical programs that support a finding of safety and effectiveness and an acceptable risk-benefit profile in the intended patient populations of any product candidates we may develop;
our ability to scale RES to produce clinical and initial commercial supply;
our ability to establish arrangements with third-party manufacturers for preclinical and clinical supply;
the availability of specialty raw materials for use in production of our product candidates;
our ability to establish new licensing or collaboration arrangements;
the receipt and related terms of regulatory approvals from the U.S. Food and Drug Administration and other applicable regulatory authorities;
our ability to establish, obtain, maintain, enforce and defend patent, trademark, trade secret protection and other intellectual property rights or regulatory exclusivity for any product candidates we may develop and our technology; and
our ability to maintain a continued acceptable safety, tolerability and efficacy profile of our product candidates following approval.

A change in the outcome of any of these variables with respect to any product candidates we may develop could significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any product candidates we may develop.

General and administrative expenses

General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation, for employees engaged in executive, legal, finance and accounting and other administrative functions. General and administrative expenses also include professional fees for legal, patent, consulting, investor and public relations and accounting and audit services as well as direct and allocated facility-related costs.

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our programs and platform. We also anticipate that we will continue to incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance costs and investor and public relations expenses associated with operating as a public company.

Other income and interest income

Other income and interest income consists of interest income earned on our invested cash balances and other miscellaneous income unrelated to our core operations.

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Results of Operations

Comparison of the three and nine months ended September 30, 2022 and 2021

The following table summarizes our results of operations for the three and nine months ended September 30, 2022 and 2021:

Three Months Ended September 30, 

Change

Nine Months Ended September 30, 

Change

(in thousands)

  

2022

  

2021

  

2022 vs 2021

  

2022

  

2021

  

2022 vs 2021

Operating expenses:

  

  

 

  

 

  

  

 

  

 

  

Research and development

$

21,192

$

21,991

$

(799)

$

75,111

$

63,400

$

11,711

General and administrative

 

11,477

 

9,667

 

1,810

 

31,383

 

24,755

 

6,628

Total operating expenses

 

32,669

 

31,658

 

1,011

 

106,494

 

88,155

 

18,339

Loss from operations

 

(32,669)

 

(31,658)

 

(1,011)

 

(106,494)

 

(88,155)

 

(18,339)

Other income:

 

  

 

  

 

  

 

  

 

  

 

  

Other income (expense) and interest income, net

 

1,363

 

(197)

 

1,560

 

2,260

 

(53)

 

2,313

Net loss

$

(31,306)

$

(31,855)

$

549

$

(104,234)

$

(88,208)

$

(16,026)

Research and development expenses

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2022 and 2021:

Three Months Ended September 30, 

Change

Nine Months Ended September 30, 

Change

(in thousands)

  

2022

  

2021

  

2022 vs 2021

  

2022

  

2021

  

2022 vs 2021

Personnel-related

$

7,258

$

6,375

$

883

$

22,427

$

17,530

$

4,897

Preclinical and manufacturing

3,339

5,946

(2,607)

11,513

19,584

(8,071)

Facilities-related