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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

 

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

 

For the quarterly period ended September 30, 2021

OR

 

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

 

For the transition period from ___________ to ____________

Commission File Number: 001-39323

 

 

VAXCYTE, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

46-4233385

(State or other jurisdiction of

incorporation or organization)

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

353 Hatch Drive

Foster City, California

94404

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (650) 837-0111

 

 

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, $0.001 par value per share

 

PCVX

 

The Nasdaq Stock Market

 

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

  

Smaller reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     Yes      No  

As of November 8, 2021, the registrant had 52,785,136 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (unaudited)

1

 

Condensed Balance Sheets

1

 

Condensed Statements of Operations

2

 

Condensed Statements of Comprehensive Loss

3

 

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

4

 

Condensed Statements of Cash Flows

6

 

Notes to Unaudited Condensed Financial Statements

7

Item 2.

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

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

35

Item 4.

Controls and Procedures

35

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

81

Item 3.

Defaults Upon Senior Securities

82

Item 4.

Mine Safety Disclosures

82

Item 5.

Other Information

82

Item 6.

Exhibits

83

Signatures

84

 

Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to “we,” “us,” “our,” “our company” and “Vaxcyte” refer to Vaxcyte, Inc.

 

“Vaxcyte,” “eCRM,” and other trademarks of ours appearing in this report are our property. This report contains additional trade names and trademarks of other companies. We do not intend our use or display of other companies’ trade names or trademarks to imply an endorsement or sponsorship of us by such companies, or any relationship with any of these companies.

i


Special Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

 

 

our expectations regarding the potential benefits, spectrum coverage and immunogenicity of our vaccine candidates;

 

our expectations regarding our preclinical study results potentially being predictive of clinical study results;

 

our belief that our pneumococcal conjugate vaccine candidates could receive regulatory approval based on a demonstration of non-inferiority to the standard of care using well-defined surrogate immune endpoints rather than requiring clinical field efficacy studies;

 

the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research and development programs;

 

our ability to advance vaccine candidates into, and successfully complete, preclinical studies and clinical trials;

 

the commercialization of our vaccine candidates, if approved;

 

estimates of our future expenses, capital requirements and our needs for additional financing;

 

our ability to compete effectively with existing competitors and new market entrants;

 

our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement;

 

our and our third-party manufacturers’ manufacturing capabilities and the scalable nature of our manufacturing process;

 

potential effects of extensive government regulation;

 

the pricing, coverage and reimbursement of our vaccine candidates, if approved;

 

our ability and the ability of our third-party contract manufacturers to operate and continue operations in light of the COVID-19 pandemic;

 

our ability to hire and retain key personnel;

 

our ability to obtain additional financing;

 

the volatility of the trading price of our common stock; and

 

our expectation regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act.

ii


Actual events or results may differ from those expressed in forward-looking statements. You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report on Form 10-Q. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.

The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report on Form 10-Q to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.

iii


Summary of Risks Affecting Our Business

 

Our business is subject to numerous risks and uncertainties, including those discussed more fully in the section titled “Risk Factors” in this Quarterly Report on Form 10-Q. These risks include, but are not limited to, the following:

 

We are in the early stages of vaccine development and have a very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

 

We have incurred significant net losses since inception and anticipate that we will continue to incur substantial net losses for the foreseeable future. We currently have no source of product revenue and may never achieve profitability. Our stock is a highly speculative investment.

 

We will require substantial additional funding to finance our operations, which may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.

 

Our approach to the discovery and development of our vaccine candidates is based on novel technologies that are unproven, which may expose us to unforeseen risks, require us to modify processes, and make it difficult to predict the time and cost of vaccine candidate development and the timing to apply for and obtain regulatory approvals.

 

Our vaccine candidates have never been tested in human subjects and are in early, preclinical stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If we are unable to complete development of or commercialize our vaccine candidates or experience significant delays in doing so, our business would be materially harmed.

 

The U.S. Food and Drug Administration, or FDA, may disagree with our regulatory plan, and we may fail to obtain regulatory approval of our vaccine candidates.

 

Our business is highly dependent on the success of VAX-24, which is in the early stages of development. If we are unable to obtain approval for VAX-24 and effectively commercialize VAX-24, our business would be significantly harmed.

 

Our primary competitors have significantly greater resources and experience than we do, which may make it difficult for us to successfully develop our vaccine candidates, or may result in others discovering, developing or commercializing products before or more successfully than us.

 

We may not be successful in our efforts to use our cell-free protein synthesis platform to expand our pipeline of vaccine candidates and develop marketable products.

 

We currently rely on third-party manufacturing and supply partners, including Lonza Ltd., or Lonza, and Sutro Biopharma, Inc., or Sutro Biopharma, to supply raw materials and components for, and manufacture of, our preclinical and clinical supplies as well as our vaccine candidates. Our inability to procure necessary raw materials or to have sufficient quantities of preclinical and clinical supplies or the inability to have our vaccine candidates manufactured, including delays or interruptions at our third-party manufacturers, or our failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.

 

Health epidemics, including the effects of the ongoing COVID-19 pandemic, have impacted and could continue to impact our business, including in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of potential clinical trial sites or other business operations.

 

The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our vaccine candidates.

 

If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

iv


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

VAXCYTE, INC.

Condensed Balance Sheets

(in thousands, except share and per share data)

(unaudited)

 

 

 

September 30, 2021

 

 

December 31, 2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

112,044

 

 

$

386,200

 

Short-term investments

 

 

166,532

 

 

 

 

Prepaid expenses and other current assets

 

 

24,373

 

 

 

2,804

 

Total current assets

 

 

302,949

 

 

 

389,004

 

Property and equipment, net

 

 

6,626

 

 

 

3,272

 

Operating lease right-of-use assets

 

 

307

 

 

 

 

Long-term investments

 

 

39,735

 

 

 

 

Restricted cash

 

 

871

 

 

 

 

Other assets

 

 

3,580

 

 

 

550

 

Total noncurrent assets

 

 

51,119

 

 

 

3,822

 

Total assets

 

$

354,068

 

 

$

392,826

 

 

 

 

 

 

 

 

 

 

Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

25,713

 

 

$

29,785

 

Accrued compensation

 

 

2,075

 

 

 

284

 

Accrued manufacturing expenses

 

 

7,033

 

 

 

13,012

 

Accrued expenses (including related party accrual of $0 and $677 as of

   September 30, 2021 and December 31, 2020, respectively)

 

 

12,027

 

 

 

3,766

 

Deferred rent — current

 

 

 

 

 

14

 

Operating lease liabilities — current

 

 

613

 

 

 

 

Total current liabilities

 

 

47,461

 

 

 

46,861

 

Deferred rent — long-term

 

 

 

 

 

10

 

Operating lease liabilities — long-term

 

 

553

 

 

 

 

Other liabilities

 

 

98

 

 

 

112

 

Total liabilities

 

 

48,112

 

 

 

46,983

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders' Equity

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value — 10,000,000 shares authorized at

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

   at September 30, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock, $0.001 par value — 500,000,000 shares authorized at

   September 30, 2021 and December 31, 2020; 52,587,855 and 51,071,593 shares

   issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

56

 

 

 

54

 

Additional paid-in capital

 

 

575,990

 

 

 

544,353

 

Accumulated other comprehensive loss

 

 

(12

)

 

 

 

Accumulated deficit

 

 

(270,078

)

 

 

(198,564

)

Total stockholders' equity

 

 

305,956

 

 

 

345,843

 

Total liabilities, redeemable convertible preferred stock and stockholders' equity

 

$

354,068

 

 

$

392,826

 

 

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

1


VAXCYTE, INC.

Condensed Statements of Operations

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (including related party expenses of $0

   and $143 for the three months ended September 30, 2021 and 2020,

   respectively, and $2,359 and $458 for the nine months ended

   September 30, 2021 and 2020, respectively)

 

$

20,428

 

 

$

16,410

 

 

$

55,337

 

 

$

58,903

 

General and administrative

 

 

6,523

 

 

 

4,898

 

 

 

18,487

 

 

 

11,225

 

Total operating expenses

 

 

26,951

 

 

 

21,308

 

 

 

73,824

 

 

 

70,128

 

Loss from operations

 

 

(26,951

)

 

 

(21,308

)

 

 

(73,824

)

 

 

(70,128

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 

 

 

 

 

 

(7

)

 

 

(7

)

Interest income

 

 

90

 

 

 

33

 

 

 

245

 

 

 

212

 

Grant income

 

 

299

 

 

 

787

 

 

 

677

 

 

 

2,152

 

Realized gain on marketable securities

 

 

1

 

 

 

 

 

 

2

 

 

 

 

Foreign currency transaction gains (losses)

 

 

(54

)

 

 

(530

)

 

 

1,393

 

 

 

(709

)

Total other income (expense), net

 

 

336

 

 

 

290

 

 

 

2,310

 

 

 

1,648

 

Net loss

 

$

(26,615

)

 

$

(21,018

)

 

$

(71,514

)

 

$

(68,480

)

Net loss per share, basic and diluted

 

$

(0.51

)

 

$

(0.41

)

 

$

(1.39

)

 

$

(3.06

)

Weighted-average shares outstanding, basic and diluted

 

 

52,187,303

 

 

 

50,895,358

 

 

 

51,627,249

 

 

 

22,354,212

 

 

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

2


VAXCYTE, INC.

Condensed Statements of Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)

 

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net Loss

 

$

(26,615

)

 

$

(21,018

)

 

$

(71,514

)

 

$

(68,480

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) on investments

 

 

(4

)

 

 

 

 

 

(12

)

 

 

 

Comprehensive loss

 

$

(26,619

)

 

$

(21,018

)

 

$

(71,526

)

 

$

(68,480

)

 

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

 

 

3


 

VAXCYTE, INC.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share data)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Other

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance — December 31, 2020

 

 

51,071,593

 

 

$

54

 

 

$

544,353

 

 

$

(198,564

)

 

$

 

 

$

345,843

 

Exercise of stock options

 

 

267,208

 

 

 

 

 

 

487

 

 

 

 

 

 

 

 

 

487

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

9

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,865

 

 

 

 

 

 

 

 

 

1,865

 

Unrealized losses on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(47

)

 

 

(47

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(21,220

)

 

 

 

 

 

(21,220

)

Balance — March 31, 2021

 

 

51,338,801

 

 

$

54

 

 

$

546,714

 

 

$

(219,784

)

 

$

(47

)

 

$

326,937

 

Exercise of stock options

 

 

190,003

 

 

 

 

 

 

466

 

 

 

 

 

 

 

 

 

466

 

Vesting of early exercised

   stock options

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Issuance of common stock under

   Employee Stock Purchase Plan

 

 

35,286

 

 

 

 

 

 

490

 

 

 

 

 

 

 

 

 

490

 

Issuance of common stock to Lonza Ltd.

 

 

399,680

 

 

 

1

 

 

 

10,000

 

 

 

 

 

 

 

 

 

10,001

 

Stock-based compensation

   expense

 

 

 

 

 

 

 

 

2,769

 

 

 

 

 

 

 

 

 

2,769

 

Unrealized gains on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

39

 

 

 

39

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(23,679

)

 

 

 

 

 

(23,679

)

Balance — June 30, 2021

 

 

51,963,770

 

 

$

55

 

 

$

560,441

 

 

$

(243,463

)

 

$

(8

)

 

$

317,025

 

Exercise of stock options

 

 

125,583

 

 

 

 

 

 

491

 

 

 

 

 

 

 

 

 

491

 

Vesting of early exercised

   stock options

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Issuance of common stock in connection

   with at-the-market offering, net of

   issuance costs of $41

 

 

498,502

 

 

 

1

 

 

 

12,119

 

 

 

 

 

 

 

 

 

 

 

12,120

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,937

 

 

 

 

 

 

 

 

 

2,937

 

Unrealized losses on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4

)

 

 

(4

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(26,615

)

 

 

 

 

 

(26,615

)

Balance — September 30, 2021

 

 

52,587,855

 

 

$

56

 

 

$

575,990

 

 

$

(270,078

)

 

$

(12

)

 

$

305,956

 

 

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

4


VAXCYTE, INC.

Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share data)

(unaudited)

 

 

 

Series A

 

 

Series B

 

 

Series C

 

 

Series D

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Convertible

 

 

Redeemable Convertible

 

 

Redeemable Convertible

 

 

Redeemable Convertible

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

 

Preferred Stock

 

 

Preferred Stock

 

 

Preferred Stock

 

 

Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Stockholders’

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity (Deficit)

 

 

Balance — December 31, 2019

 

 

6,225,719

 

 

$

24,967

 

 

 

6,786,896

 

 

$

55,151

 

 

 

7,377,480

 

 

$

80,192

 

 

 

 

 

$

 

 

 

 

4,059,909

 

 

$

7

 

 

$

2,967

 

 

$

(109,347

)

 

$

(106,373

)

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

28,837

 

 

 

 

 

 

49

 

 

 

 

 

 

49

 

 

Issuance of common

   stock related to early

   exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,819

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early exercised

   stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

128

 

 

 

 

 

 

128

 

 

Issuance of Series D

   redeemable convertible

   preferred stock, net

   of issuance cost of $125

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,220,242

 

 

 

109,875