UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 12, 2020

 

VAXCYTE, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39323

46-4233385

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS 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

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. 

 

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On August 12, 2020, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2020. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.

The information in this Item 2.02 and Item 9.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

 

Description

99.1

 

Press Release of Vaxcyte, Inc., dated August 12, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

*

Filed herewith.

1


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Company Name

 

 

 

 

Date: August 12, 2020

 

By:

/s/ Andrew Guggenhime

 

 

 

Andrew Guggenhime

 

 

 

Chief Financial Officer and Chief Business Officer

 

2

pcvx-ex991_6.htm

Exhibit 99.1

Vaxcyte Reports Second Quarter 2020 Financial Results and Provides Business Update

 

Foster City, Calif., August 12, 2020 – Vaxcyte, Inc., formerly known as SutroVax, a next-generation vaccine company seeking to improve global health by developing superior and

novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the second quarter ended June 30, 2020 and provided a business update.

 

“Despite the pandemic, the first half of 2020 was marked by significant progress across all aspects of our business, culminating with our successful initial public offering,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “With key additions to our leadership team and the completion of both our Series D financing and IPO in the past several months, we are well positioned to execute our strategy and advance our pipeline of novel vaccine candidates, led by VAX-24, our 24-valent investigational pneumococcal conjugate vaccine.”

 

Recent Highlights

 

 

Completed Upsized Initial Public Offering (IPO): On June 16, 2010, Vaxcyte completed its IPO of 17,968,750 shares of common stock, which included the full exercise of the underwriters’ option to purchase 2,343,750 additional shares, at a public offering price of $16.00 per share, resulting in aggregate net proceeds of $264.1 million.

 

Achieved VAX-24 Manufacturing Milestones: Vaxcyte achieved several key manufacturing milestones for VAX-24, its lead vaccine candidate, including release of the good manufacturing practices (GMP) batches of the eCRM protein carrier, completion of the GMP batches of the 24 polysaccharide antigens and initiation of the GMP batches of the conjugate drug substances. VAX-24 is the Company’s 24-valent pneumococcal conjugate vaccine (PCV) candidate being developed for the prevention of invasive pneumococcal disease (IPD).

 

Amended CARB-X Agreement for VAX-A1 Program: In July 2020, Vaxcyte’s grant from CARB-X related to its VAX-A1 vaccine candidate was increased from 50% to 90% of reimbursable expenses during the initial funding period. VAX-A1 is a novel conjugate vaccine designed to provide universal protection from infections caused by Group A Strep bacteria, which include pharyngitis, toxic shock syndrome and necrotizing fasciitis.

 

Strengthened Executive Leadership and Board: In May 2020, Vaxcyte appointed Andrew Guggenhime as Chief Financial Officer and Chief Business Officer, bringing more than two decades of financial and strategic leadership experience in healthcare. In April 2020, Vaxcyte appointed Halley Gilbert to its board of directors, bringing over 20 years of biotechnology leadership experience.

 

 


Anticipated Milestones

 

VAX-24: Vaxcyte expects to submit an Investigational New Drug (IND) application for VAX-24 to the U.S. Food and Drug Administration (FDA) and initiate its Phase 1/2 clinical proof-of-concept study in the second half of 2021. Vaxcyte expects to announce topline data from this study in 2022.

 

VAX-A1: Vaxcyte expects to nominate a final vaccine candidate for VAX-A1 in 2021.

 

VAX-PG: Vaxcyte expects to nominate a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease, in 2021.

 

Second Quarter 2020 Financial Results

 

 

Cash Position: Cash and cash equivalents were $410.0 million as of June 30, 2010, compared to $59.0 million as of December 31, 2019, an increase due to Vaxcyte’s IPO in June 2020 and Series D financing in March 2020.

 

Research & Development (R&D) Expenses: R&D expenses were $18.2 million for the three months ended June 30, 2020 as compared to $10.0 million for the same period in 2019. The increase was due primarily to an increase in manufacturing expenses related to the Company’s VAX-24 program.

 

General & Administrative (G&A) Expenses: G&A expenses were $3.0 million for the three months ended June 30, 2020 as compared to $2.3 million for the same period in 2019. The increase was due primarily to an increase in personnel-related expenses.

 

 

Net Loss: For the three months ended June 30, 2020, net loss was $20.3 million, compared to $10.7 million for the three months ended June 30, 2019.

 

About Vaxcyte

Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company’s cell-free protein synthesis platform, comprising the XpressCFTM platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte’s proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte’s lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). Vaxcyte’s pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for IPD and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. For more information, visit www.vaxcyte.com.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the process and timing of anticipated future development of Vaxcyte’s vaccine candidates, including VAX-24, VAX-XP, VAX-A1 and VAX-PG. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,”


“project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on August 12, 2020, its prospectus dated June 11, 2020 filed with the SEC on June 15, 2020 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

 

# # #

 

Investor Contact:

Andrew Guggenhime, Chief Financial Officer & Chief Business Officer

Vaxcyte, Inc.

650-837-0111

investors@vaxcyte.com

 



Vaxcyte, Inc.

 

Condensed Statements of Operations

 

(in thousands, except share and per share amounts)

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

$

18,178

 

 

$

9,968

 

 

$

42,493

 

 

$

22,595

 

General and administrative (1)

 

 

3,046

 

 

 

2,264

 

 

 

6,327

 

 

 

3,580

 

Total operating expenses

 

 

21,224

 

 

 

12,232

 

 

 

48,820

 

 

 

26,175

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(21,224

)

 

 

(12,232

)

 

 

(48,820

)

 

 

(26,175

)

Other income(expense), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 

 

 

(11

)

 

 

(7

)

 

 

(24

)

Interest income

 

 

44

 

 

 

181

 

 

 

179

 

 

 

418

 

Grant income

 

 

1,036

 

 

 

 

 

 

1,365

 

 

 

 

Foreign currency transaction losses

 

 

(176

)

 

 

(53

)

 

 

(179

)

 

 

(231

)

Change in fair value of the redeemable convertible preferred stock tranche liability

 

 

 

 

 

1,450

 

 

 

 

 

 

1,676

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total other income (expense), net

 

 

904

 

 

 

1,567

 

 

 

1,358

 

 

 

1,839

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and comprehensive loss

 

$

(20,320

)

 

$

(10,665

)

 

$

(47,462

)

 

$

(24,336

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(1.72

)

 

$

(2.90

)

 

$

(5.99

)

 

$

(6.62

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding, basic and diluted

 

 

11,803,778

 

 

 

3,682,897

 

 

 

7,926,818

 

 

 

3,677,032

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Amounts include stock-based compensation expense as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

374

 

 

$

87

 

 

$

523

 

 

$

175

 

General and administrative

 

 

915

 

 

 

191

 

 

 

1,138

 

 

 

370

 

Total stock-based compensation expense

 

$

1,289

 

 

$

278

 

 

$

1,661

 

 

$

545

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaxcyte, Inc.

 

 

 

 

 

Summary Consolidated Balance Sheet Data

 

 

 

 

 

(in thousands)

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

 

 

 

 

 

 

 

 

2020

 

 

2019

 

 

 

 

 

Cash and cash equivalents

 

 

 

 

 

$

410,046

 

 

$

58,976

 

 

 

 

 

Total assets

 

 

 

 

 

 

416,248

 

 

 

65,698

 

 

 

 

 

Redeemable convertible preferred stock

 

 

 

 

 

 

 

 

 

160,310

 

 

 

 

 

Total stockholders' equity (deficit)

 

 

 

 

 

 

383,210

 

 

 

(106,373

)