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 August 8, 2023, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended June 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: |
August 8, 2023 |
By: |
/s/ Andrew Guggenhime |
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Andrew Guggenhime |
Exhibit 99.1
Vaxcyte Reports Second Quarter 2023 Financial Results and Provides Business Update
-- Advanced Ongoing VAX-24 Phase 2 Infant Study to Second Stage, Dosing First New Participants in July 2023; Topline Data from Primary Immunization Series Expected by 2025 --
-- Completed Phase 2 VAX-24 Adult Program for the Prevention of Invasive Pneumococcal Disease (IPD); Topline Phase 3 Data Expected in 2025 --
-- VAX-31 Adult Investigational New Drug (IND) Application Clearance Expected in Fourth Quarter of 2023; Topline Phase 1/2 Data Expected in 2024 --
-- $1.4 Billion in Cash, Cash Equivalents and Investments as of June 30, 2023, Including Net Proceeds of $545.3 Million from April Public Offering --
SAN CARLOS, Calif., August 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 second quarter ended June 30, 2023 and provided a business update.
“The need for vaccines that offer broader protection to prevent pneumococcal disease was recently reaffirmed by the Advisory Committee on Immunization Practices, and we believe the positive data from the VAX-24 adult Phase 2 clinical program support the potential best-in-class profile for our 24-valent PCV candidate to deliver broader coverage and improved immune responses compared to the standard-of-care,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Our strong balance sheet provides a solid foundation as we advance our PCV franchise and pipeline programs. We look forward to continued progress, including the finalization of our VAX-24 adult Phase 3 program and licensure requirements, and remain on track to deliver topline Phase 3 data in 2025.”
Key Second Quarter and Recent Highlights
In Memoriam
“In early July, we were saddened by the sudden passing of Michael E. Kamarck, Ph.D., a member of our Board of Directors. Mike was a luminary in the biopharmaceutical industry, with long-standing, major contributions in vaccine and therapeutic product development and manufacturing that spanned over four decades. His desire to improve the lives of people around the world was evident through this commitment to public health and his support of companies large and small, on which he left a lasting mark. Mike’s compassionate nature extended far beyond his work as a beloved husband, father, grandfather and friend. We extend our deepest condolences to his family and all those he impacted throughout his life,” said Mr. Pickering.
Anticipated Key Milestones
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones, including:
Second 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, including the viability and market opportunity of Vaxcyte’s Shigella vaccine candidate; the timing and availability of data for the VAX-24 adult and infant studies and related regulatory interactions; the timing of the 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; 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 August 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:
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 June 30, |
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Six Months Ended June 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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$ |
72,691 |
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$ |
38,469 |
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$ |
130,771 |
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$ |
70,147 |
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General and administrative (1) |
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14,456 |
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9,417 |
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27,567 |
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16,960 |
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Total operating expenses |
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87,147 |
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47,886 |
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158,338 |
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87,107 |
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Loss from operations |
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(87,147 |
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(47,886 |
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(158,338 |
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(87,107 |
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Other income (expense), net: |
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Interest expense |
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— |
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(2 |
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— |
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(2 |
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Interest income |
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16,451 |
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399 |
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26,844 |
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533 |
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Grant income |
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2,464 |
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690 |
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3,119 |
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850 |
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Realized losses on marketable securities |
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— |
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— |
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— |
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— |
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Foreign currency transaction losses |
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(107 |
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(1,733 |
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(426 |
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(1,792 |
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Total other income (expense), net |
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18,808 |
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(646 |
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29,537 |
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(411 |
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Net loss |
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$ |
(68,339 |
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$ |
(48,532 |
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$ |
(128,801 |
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$ |
(87,518 |
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Net loss per share, basic and diluted |
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$ |
(0.70 |
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$ |
(0.80 |
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$ |
(1.40 |
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$ |
(1.48 |
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Weighted-average shares outstanding, basic and diluted |
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98,057,870 |
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60,818,778 |
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92,165,076 |
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59,192,182 |
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(1) Amounts include stock-based compensation expense as follows: |
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Research and development |
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$ |
5,911 |
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$ |
2,347 |
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$ |
10,438 |
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$ |
4,122 |
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General and administrative |
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6,633 |
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3,547 |
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11,754 |
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5,871 |
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Total stock-based compensation expense |
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$ |
12,544 |
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$ |
5,894 |
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$ |
22,192 |
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$ |
9,993 |
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Vaxcyte, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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June 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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$ |
1,440,790 |
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$ |
957,925 |
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Total assets |
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1,502,819 |
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1,006,178 |
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Total stockholders' equity |
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1,433,376 |
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953,613 |
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