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, 2024, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter and full year ended December 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: |
February 27, 2024 |
By: |
/s/ Andrew Guggenhime |
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Andrew Guggenhime |
Exhibit 99.1
Vaxcyte Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
-- VAX-31 Adult Program Phase 1/2 Study Enrollment Complete; Topline Safety, Tolerability and Immunogenicity Data Expected in Third Quarter of 2024 --
-- Completed Successful VAX-24 Phase 2 Adult Program and End-of-Phase 2 Meeting; VAX-24 is Phase 3-Ready in Adults --
-- Following VAX-31 Adult Phase 1/2 Study Readout, Vaxcyte to Advance VAX-24 or VAX-31 to Adult Phase 3 Program --
-- Enrollment in VAX-24 Infant Phase 2 Study Nearing Completion; Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 --
-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --
-- $1.2 Billion in Cash, Cash Equivalents and Investments as of December 31, 2023, Excluding Net Proceeds of $816.5 Million from Recent Public Offering --
-- Company to Host Webcast/Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT --
SAN CARLOS, Calif., February 27, 2024 – 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, 2023, and provided a business update.
“Over the past year, we made significant progress across clinical, regulatory and manufacturing with our broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) franchise, comprising VAX-24 and VAX-31, which are designed to prevent invasive pneumococcal disease (IPD) in adults and children. These notable achievements, coupled with two follow-on equity financings totaling approximately $1.4 billion in gross proceeds, fortified our efforts to build what we believe is a best-in-class PCV franchise,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “This year promises an important anticipated milestone with the VAX-31 adult Phase 1/2 topline data expected in the third quarter, following which we intend to advance either VAX-24 or VAX-31 into a Phase 3 adult clinical program. Additionally, enrollment in the VAX-24 infant Phase 2 study is nearing completion, and we remain on track to announce Phase 2 topline data from the primary immunization series by the end of the first quarter of 2025.”
“The follow-on equity offering completed earlier this month generated approximately $816.5 million in net proceeds, further strengthening our balance sheet to advance our PCV franchise, including Phase 3 studies and manufacturing scale-up, along with our early-stage vaccine candidates while also growing the organization in support of these initiatives,” said Andrew
Guggenhime, President and Chief Financial Officer of Vaxcyte. “We look forward to delivering multiple anticipated Phase 3 data readouts over the next few years as we progress toward a Biologics License Application (BLA) submission for either the VAX-24 or VAX-31 adult program.”
Key 2023 and 2024 to Date Highlights
PCV Franchise Adult Indication:
PCV Franchise Infant Indication:
Global Manufacturing:
Equity Financings:
Anticipated Key Milestones
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones:
PCV Franchise Adult Indication
If VAX-24:
If VAX-31:
PCV Franchise Infant Indication
Upcoming March Investor Conferences
Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company’s website at http://investors.vaxcyte.com for approximately 30 days following each conference.
Fourth Quarter and Full Year 2023 Financial Results
Conference Call and Webcast
Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial 800-225-9448 (domestic) or 203-518-9708 (international) and refer to conference ID PCVXQ423. A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.vaxcyte.com. After the live webcast, the event will remain archived on Vaxcyte’s website for 30 days.
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 Phase 3-ready 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD. VAX-31, the Company’s next-generation 31-valent PCV, is the broadest-spectrum PCV candidate in the clinic today. Both VAX-24 and VAX-31 are designed to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for a significant portion of IPD in circulation and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.
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 candidate 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, the ability to deliver a potentially best-in-class PCV franchise and the improvement upon the standard-of-care; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates; the advancement of either VAX-24 or VAX-31 into a Phase 3 adult clinical program, and the timing of such studies and their data readouts; the design, timing and availability of data for the VAX-24 infant Phase 2 study; the design, timing and availability of data for the VAX-31 adult Phase 1/2 study;; the timing of a potential BLA submission for VAX-24 or VAX-31; the demand for Vaxcyte’s vaccine candidates; the potential global commercialization of Vaxcyte’s PCV candidates in both the adult and pediatric populations; Vaxcyte’s ability to establish global commercial manufacturing capacity for its PCV candidates; Vaxcyte’s plans to utilize existing Lonza infrastructure to advance clinical development and support the anticipated initial U.S. launch of VAX-24 or VAX-31 for the adult population; 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 Annual Report on Form 10-K filed with the SEC on February 27, 2024 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
media@vaxcyte.com
Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
investors@vaxcyte.com
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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2023 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development (1) |
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$ |
332,341 |
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$ |
169,451 |
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$ |
78,411 |
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Acquired manufacturing rights |
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75,000 |
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22,995 |
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- |
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General and administrative (1) |
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60,700 |
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39,810 |
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25,259 |
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Total operating expenses |
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468,041 |
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232,256 |
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103,670 |
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Loss from operations |
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(468,041 |
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(232,256 |
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(103,670 |
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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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(7 |
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Interest income |
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62,907 |
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8,356 |
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344 |
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Grant income |
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4,765 |
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1,931 |
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1,585 |
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Realized gains on marketable securities |
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— |
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— |
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2 |
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Loss on disposal of fixed assets |
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— |
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(44 |
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— |
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Foreign currency transaction (losses) gains |
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(1,897 |
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(1,470 |
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1,669 |
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Total other income, net |
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65,775 |
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8,771 |
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3,593 |
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Net loss |
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(402,266 |
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$ |
(223,485 |
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$ |
(100,077 |
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Net loss per share, basic and diluted |
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$ |
(4.14 |
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$ |
(3.44 |
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$ |
(1.93 |
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Weighted-average shares outstanding, basic and diluted |
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97,157,690 |
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64,877,988 |
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51,922,108 |
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(1) Amounts include stock-based compensation expense as follows: |
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Research and development |
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$ |
23,275 |
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$ |
9,899 |
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$ |
3,954 |
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General and administrative |
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25,485 |
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13,751 |
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6,775 |
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Total stock-based compensation expense |
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$ |
48,760 |
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$ |
23,650 |
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$ |
10,729 |
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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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2023 |
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2022 |
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Cash, cash equivalents and investments |
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$ |
1,242,902 |
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$ |
957,925 |
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Total assets |
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1,407,917 |
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1,006,178 |
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Total stockholders' equity |
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1,240,468 |
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953,613 |
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