SAN CARLOS, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- 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, 2024, and provided a business update.
“We continue to make meaningful progress across our business, including for our pneumococcal conjugate vaccine (PCV) candidates, VAX-24 and VAX-31, which are intended to deliver the broadest spectrum of coverage against invasive pneumococcal disease (IPD),” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We remain on track to announce the VAX-31 adult Phase 1/2 study topline safety, tolerability and immunogenicity data in the third quarter of this year, following which we plan to advance either VAX-24 or VAX-31 into Phase 3 clinical development in adults. Additionally, with enrollment completed in the VAX-24 infant Phase 2 study, we expect to deliver topline data from the primary immunization series by the end of the first quarter of 2025. Together, these two milestones will provide significant insight into our PCV franchise’s ability to achieve its full potential across the adult and pediatric populations.”
“We closed the first quarter with a strong balance sheet bolstered by $816.5 million in net proceeds from the follow-on equity offering in February, propelling advancement of our PCV franchise and the scale-up of our manufacturing infrastructure,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “We also continue to progress our early-stage pipeline led by VAX-A1, a vaccine candidate designed to prevent Group A Strep infections. We believe our cell-free platform has the potential to enable the development of first-in-class vaccines to prevent or treat bacterial infections, which have serious and costly health consequences when left unchecked.”
Key First Quarter Highlights
PCV Franchise Adult Indication:
PCV Franchise Infant Indication:
Equity Financing:
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 May and June Investor Conferences
Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences, and 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:
First Quarter 2024 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 Phase 3-ready 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (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 first-in-class PCV franchise and 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 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 Lonza infrastructure to support the potential global commercialization of Vaxcyte’s PCV programs; the ability of Vaxcyte’s cell-free platform to potentially enable the development of first-in-class vaccines to prevent or treat bacterial infections; 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 May 8, 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:
Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
This email address is being protected from spambots. You need JavaScript enabled to view it.
Janet Graesser, Senior Vice President, Corporate Communications and Investor Relations
Vaxcyte, Inc.
917-685-8799
This email address is being protected from spambots. You need JavaScript enabled to view it.
Vaxcyte, Inc. | ||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||
Three Months Ended March 31, | ||||||||||||
2024 | 2023 | |||||||||||
Operating expenses: | ||||||||||||
Research and development (1) | $ | 94,587 | $ | 58,080 | ||||||||
General and administrative (1) | 19,885 | 13,112 | ||||||||||
Total operating expenses | 114,472 | 71,192 | ||||||||||
Loss from operations | (114,472 | ) | (71,192 | ) | ||||||||
Other income (expense), net: | ||||||||||||
Interest income | 21,666 | 10,393 | ||||||||||
Grant income | 126 | 654 | ||||||||||
Realized gains on marketable securities | 22 | - | ||||||||||
Foreign currency transaction losses | (2,362 | ) | (317 | ) | ||||||||
Total other income (expense), net | 19,452 | 10,730 | ||||||||||
Net loss | $ | (95,020 | ) | $ | (60,462 | ) | ||||||
Net loss per share, basic and diluted | $ | (0.85 | ) | $ | (0.70 | ) | ||||||
Weighted-average shares outstanding, basic and diluted | 111,690,951 | 86,206,817 | ||||||||||
(1) Amounts include stock-based compensation expense as follows: | ||||||||||||
Research and development | $ | 8,818 | $ | 4,527 | ||||||||
General and administrative | 8,811 | 5,121 | ||||||||||
Total stock-based compensation expense | $ | 17,629 | $ | 9,648 | ||||||||
Vaxcyte, Inc. | ||||||||||||
Summary Consolidated Balance Sheet Data | ||||||||||||
(in thousands) | ||||||||||||
March 31, | December 31, | |||||||||||
2024 | 2023 | |||||||||||
Cash, cash equivalents and investments | $ | 1,899,765 | $ | 1,242,902 | ||||||||
Total assets | 2,091,305 | 1,407,917 | ||||||||||
Total stockholders' equity | 1,983,983 | 1,240,468 | ||||||||||
Last Trade: | US$111.58 |
Daily Change: | -0.52 -0.46 |
Daily Volume: | 2,139,947 |
Market Cap: | US$12.450B |
September 06, 2024 September 03, 2024 September 03, 2024 |
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