UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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 May 8, 2023, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended March 31, 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: |
May 8, 2023 |
By: |
/s/ Andrew Guggenhime |
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Andrew Guggenhime |
Exhibit 99.1
Vaxcyte Reports First Quarter 2023 Financial Results and Provides Business Update
-- Positive Data from VAX-24 Phase 2 Study in Adults Aged 65 and Older Demonstrated Robust Immune Responses Across all 24 Serotypes (ST) at all Doses, Confirming Prior Phase 2 Results in Adults Aged 50-64 --
-- Full Six-Month Safety Data from Both Adult Studies Demonstrated VAX-24 Safety and Tolerability Results Similar to PCV20 at All Doses Studied --
-- Dosed First Participants in Infant Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease (IPD) --
-- VAX-31 Progressing with Adult Investigational New Drug (IND) Application Submission and Subsequent Clearance Announcement Expected in Second Half 2023 and Topline Phase 1/2 Data in 2024 --
-- $949.9 Million in Cash, Cash Equivalents and Investments as of March 31, 2023, Excluding Net Proceeds of $545.1 Million from Recent Public Offering --
SAN CARLOS, Calif., May 8, 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 first quarter ended March 31, 2023 and provided a business update.
“We believe the recently announced positive results from the Phase 2 study in adults aged 65 and older confirm the clinical potential of our lead vaccine candidate in the adult population and validate our carrier-sparing, cell-free platform,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “These data support a potential best-in-class profile for VAX-24 as well as our goal of creating PCVs that provide broader coverage and better immune responses compared to the standard-of-care vaccines. We look forward to discussing our Phase 2 program results with regulators as we advance towards a Phase 3 pivotal study for VAX-24 from which we expect topline data in 2025.”
“With the recent follow-on equity offering, which generated approximately $545 million in net proceeds, our balance sheet is further strengthened,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “This allows us to expand our manufacturing capabilities as we continue advancing our PCV franchise, comprised of VAX-24 and VAX-31, our 31-valent PCV candidate for which we expect to submit and announce the subsequent clearance of our adult IND application in the second half of this year.”
Key First Quarter and Recent Highlights
Anticipated Key Milestones
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones, including:
First 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. 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-31, a 31-valent PCV candidate; 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, 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; the timing and availability of data for VAX-24 adult and infant studies and related regulatory interactions; the timing of submission and clearance of an IND application for the VAX-31 adult program and the timing and availability of the Phase 1/2 topline data for such program; the potential benefits and opportunities available as a result of the Breakthrough Therapy designation for VAX-24 in adults; the ability to expand manufacturing capabilities; 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; impacts of COVID-19; 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 May 8, 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:
Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
Janet Graesser, Vice President, Corporate Communications and Investor Relations
Vaxcyte, Inc.
917-685-8799
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 March 31, |
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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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$ |
58,080 |
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$ |
31,678 |
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General and administrative (1) |
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13,112 |
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7,543 |
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Total operating expenses |
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71,192 |
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39,221 |
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Loss from operations |
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(71,192 |
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(39,221 |
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Other income (expense), net: |
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Interest income |
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10,393 |
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134 |
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Grant income |
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654 |
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160 |
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Realized losses on marketable securities |
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— |
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(65 |
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Foreign currency transaction (losses) gains |
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(317 |
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6 |
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Total other income (expense), net |
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10,730 |
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235 |
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Net loss |
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$ |
(60,462 |
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$ |
(38,986 |
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Net loss per share, basic and diluted |
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$ |
(0.70 |
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$ |
(0.68 |
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Weighted-average shares outstanding, basic and diluted |
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86,206,817 |
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57,547,808 |
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(1) Amounts include stock-based compensation expense as follows: |
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Research and development |
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$ |
4,527 |
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$ |
1,775 |
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General and administrative |
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5,121 |
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2,324 |
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Total stock-based compensation expense |
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$ |
9,648 |
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$ |
4,099 |
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Vaxcyte, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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March 31, |
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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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$ |
949,853 |
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$ |
957,925 |
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Total assets |
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1,008,163 |
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1,006,178 |
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Total stockholders' equity |
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944,771 |
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953,613 |
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