PCVX 8-K
Vaxcyte, Inc. (PCVX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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:
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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 November 6, 2023, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2023. 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 |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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VAXCYTE, INC. |
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Date: |
November 6, 2023 |
By: |
/s/ Andrew Guggenhime |
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Andrew Guggenhime |
Exhibit 99.1
Vaxcyte Reports Third Quarter 2023 Financial Results and Provides Business Update
-- Completed Successful End-of-Phase 2 Meeting with FDA for VAX-24; Topline Phase 3 Data in Adults Expected in 2025 --
-- Received FDA Clearance of VAX-31 Adult IND Application; Phase 1/2 Study Initiation Expected This Quarter and Topline Data Expected in the Second Half of 2024 --
-- Advanced Ongoing VAX-24 Infant Phase 2 Study; Topline Data from Primary Immunization Series Expected by 2025 --
-- Expanded Collaboration with Lonza for Global Commercial Manufacturing of Broad-Spectrum Pneumococcal Conjugate Vaccine Candidates,
VAX-24 and VAX-31, in Adult and Pediatric Populations --
-- $1.4 Billion in Cash, Cash Equivalents and Investments as of September 30, 2023 --
SAN CARLOS, Calif., November 6, 2023 – Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the third quarter ended September 30, 2023 and provided a business update.
“Vaxcyte has continued to make significant strides toward our goal of building a best-in-class PCV franchise, including VAX-24 and VAX-31, with the intent of delivering the broadest-spectrum of coverage against invasive pneumococcal disease,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Following the positive results from the VAX-24 adult Phase 2 clinical studies, we are pleased to have completed a successful End-of-Phase 2 meeting with the FDA focused on the clinical design of our Phase 3 program. We look forward to continued interactions with regulators through the first quarter of next year to finalize the CMC-related licensure requirements as we prepare to initiate the VAX-24 adult Phase 3 program, with topline data from the pivotal, non-inferiority study expected in 2025.”
Mr. Pickering continued, “Additionally, we are excited to advance VAX-31, which will be the broadest-spectrum PCV to enter the clinic, into a Phase 1/2 study this quarter following the recent FDA clearance of the IND application. We expect to announce topline safety, tolerability and immunogenicity data from this study in the second half of 2024.”
Key Third Quarter and Recent Highlights
Anticipated Key Milestones
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones, including:
Third Quarter 2023 Financial Results
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD and is poised to move into late-stage development. VAX-31, the only 31-valent PCV in development, is a follow-on candidate to VAX-24 and part of the Company’s PCV franchise.
Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. 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 potential benefits of VAX-24 and VAX-31, including breadth of coverage and clinical potential, the ability to deliver a potentially best-in-class profile and the improvement upon the standard-of-care; the design, process and timing of anticipated future development of Vaxcyte’s vaccine candidates, including the timing and availability of data for the VAX-24 adult and infant studies and related regulatory interactions and the timing of the initiation of the VAX-31 adult Phase 1/2 study and availability of the corresponding topline data; the potential of VAX-31 to serve as a follow-on candidate to VAX-24; the ability of Vaxcyte to commercialize VAX-24 and VAX-31; the timing and strategy regarding the initial commercial launch of VAX-24; the ability of Vaxcyte’s dedicated manufacturing suite as part of Lonza’s Ibex® facility to support the manufacture of key components, including the drug substances; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and 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 November 6, 2023 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of
such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. 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.
# # #
Contacts:
Janet Graesser, Vice President, Corporate Communications and Investor Relations
Vaxcyte, Inc.
917-685-8799
Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
Vaxcyte, Inc. |
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Condensed Statements of Operations |
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(in thousands, except share and per share amounts) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development (1) |
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$ |
97,421 |
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$ |
47,679 |
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$ |
228,191 |
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$ |
117,825 |
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General and administrative (1) |
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15,605 |
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10,898 |
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43,174 |
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27,858 |
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Total operating expenses |
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113,026 |
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58,577 |
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271,365 |
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145,683 |
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Loss from operations |
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(113,026 |
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(58,577 |
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(271,365 |
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(145,683 |
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Other income (expense), net: |
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Interest expense |
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— |
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— |
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— |
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(2 |
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Interest income |
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18,495 |
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1,190 |
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45,339 |
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1,723 |
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Grant income |
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1,640 |
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157 |
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4,759 |
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1,006 |
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Foreign currency transaction gains (losses) |
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227 |
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(687 |
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(198 |
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(2,479 |
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Total other income, net |
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20,362 |
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660 |
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49,900 |
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248 |
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Net loss |
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$ |
(92,664 |
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$ |
(57,917 |
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$ |
(221,465 |
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$ |
(145,435 |
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Net loss per share, basic and diluted |
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$ |
(0.91 |
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$ |
(0.93 |
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$ |
(2.32 |
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$ |
(2.42 |
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Weighted-average shares outstanding, basic and diluted |
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101,668,655 |
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61,989,347 |
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95,367,751 |
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60,166,583 |
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(1) Amounts include stock-based compensation expense as follows: |
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Research and development |
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$ |
6,335 |
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$ |
2,682 |
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$ |
16,774 |
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$ |
6,804 |
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General and administrative |
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6,885 |
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3,966 |
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18,639 |
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9,837 |
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Total stock-based compensation expense |
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$ |
13,220 |
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$ |
6,648 |
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$ |
35,413 |
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$ |
16,641 |
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Vaxcyte, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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September 30, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents and investments |
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$ |
1,434,248 |
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$ |
957,925 |
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Total assets |
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1,496,057 |
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1,006,178 |
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Total stockholders' equity |
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1,402,716 |
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953,613 |
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