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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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 February 27, 2023, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter and full year ended December 31, 2022. 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: |
February 27, 2023 |
By: |
/s/ Andrew Guggenhime |
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Andrew Guggenhime |
Exhibit 99.1
Vaxcyte Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
-- Company Received U.S. Food and Drug Administration (FDA) Clearance of VAX-24 Infant Investigational New Drug (IND) Application and Expects to Initiate Phase 2 Study in Second Quarter 2023 --
-- Topline Safety, Tolerability and Immunogenicity Results from VAX-24 Phase 2 Study in Adults 65 and Older on Track for Second Quarter 2023 --
-- Positive Topline Results from VAX-24 Phase 1/2 Proof-of-Concept Study in Adults Aged 18-64 Indicate Potential Best-in-Class Profile and Validate Company’s Carrier-Sparing Approach --
-- VAX-31 Progressing with Adult IND Application Expected in Second Half 2023 and Topline Phase 1/2 Data in 2024 --
-- Successfully Raised Approximately $805 Million in Gross Proceeds in Two Follow-On Equity Offerings in 2022; $957.9 Million in Cash, Cash Equivalents and Investments as of December 31, 2022 --
-- Company to Host Webcast/Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT --
SAN CARLOS, Calif., February 27, 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 fourth quarter and full year ended December 31, 2022 and provided a business update.
“Last year was transformational for Vaxcyte, with the positive VAX-24 clinical proof-of-concept data validating the potential of our pneumococcal conjugate vaccine (PCV) franchise and carrier-sparing approach to enable the development of broader-spectrum PCVs for the prevention of invasive pneumococcal disease (IPD). These results also support the utility of our cell-free platform that is being deployed across our full pipeline of novel vaccine candidates,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We also added to our strong foundation by bolstering our balance sheet, raising approximately $805 million in gross proceeds from two follow-on equity offerings that provide additional funding for the continued development of VAX-24 and our earlier-stage pipeline, including VAX-31, our 31-valent PCV candidate, through important incremental milestones.”
Mr. Pickering continued, “Progressing our VAX-24 adult and infant clinical programs is a critical focus for 2023 and we remain on track to announce the topline Phase 2 data from the study in adults 65 and older and initiate the Phase 2 infant study in the second quarter of this year. We anticipate additional milestones across our broader portfolio, including the submission of the VAX-31 adult IND application to the FDA in the second half of the year, with topline data expected in 2024.”
Key 2022 and 2023 Highlights to Date
Anticipated Key Milestones
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones, including:
Fourth Quarter and Full Year 2022 Financial Results
Conference Call and Webcast
Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2023, at 4:30 p.m. ET / 1:30 p.m. PT. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. A live audio webcast will be available in the Investors & Media section of the Company’s website at www.vaxcyte.com. A replay of the webcast will be available for 30 days following the call.
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, the ability to deliver a potentially best-in-class PCV and the improvement upon the standard-of-care; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates; the timing and availability of data for the VAX-24 Phase 2 and Phase 3 studies and related regulatory interactions; the timing of the initiation of the VAX-24 Phase 2 infant study and the availability of Phase 2 topline results; the timing and submission 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 demand for Vaxcyte’s vaccine candidates; the potential benefits and opportunities available as a result of the Breakthrough Therapy designation for VAX-24 in adults; 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 Annual Report on Form 10-K filed with the SEC on February 27, 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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Year Ended December 31, |
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2022 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development (1) |
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$ |
169,451 |
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$ |
78,411 |
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$ |
73,564 |
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Acquired manufacturing rights |
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22,995 |
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- |
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- |
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General and administrative (1) |
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39,810 |
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25,259 |
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16,017 |
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Total operating expenses |
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232,256 |
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103,670 |
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89,581 |
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Loss from operations |
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(232,256 |
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(103,670 |
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(89,581 |
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Other income (expense), net |
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Interest expense |
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(2 |
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(7 |
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(7 |
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Interest income |
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8,356 |
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344 |
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244 |
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Grant income |
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1,931 |
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1,585 |
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2,478 |
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Realized gains on marketable securities |
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— |
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2 |
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— |
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Loss on disposal of fixed assets |
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(44 |
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— |
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— |
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Foreign currency transaction (losses) gains |
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(1,470 |
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1,669 |
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(2,351 |
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Total other income (expense), net |
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8,771 |
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3,593 |
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364 |
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Net loss and comprehensive loss |
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(223,485 |
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$ |
(100,077 |
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$ |
(89,217 |
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Net loss per share, basic and diluted |
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$ |
(3.44 |
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$ |
(1.93 |
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$ |
(3.02 |
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Weighted-average shares outstanding, basic and diluted |
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64,877,988 |
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51,922,108 |
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29,545,810 |
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(1) Amounts include stock-based compensation expense as follows: |
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Research and development |
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$ |
9,899 |
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$ |
3,954 |
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$ |
1,861 |
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General and administrative |
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13,751 |
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6,775 |
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3,573 |
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Total stock-based compensation expense |
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$ |
23,650 |
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$ |
10,729 |
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$ |
5,434 |
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Vaxcyte, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and investments |
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$ |
957,925 |
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$ |
273,087 |
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Total assets |
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1,006,178 |
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324,337 |
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Total stockholders' equity |
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953,613 |
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284,018 |
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