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-- Vaxcyte Reported Positive Topline Data from Phase 1/2 Proof-of-Concept Study of its 24-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate Being Investigated for the Prevention of Invasive Pneumococcal Disease (IPD) in Adults Aged 18-64 --
-- Phase 1/2 Study Met Safety, Tolerability and Immunogenicity Objectives; Findings Indicate a Potential Best-in-Class Profile for VAX-24 --
-- Company Advancing VAX-24 in Adult and Pediatric Populations with Submission of Infant Investigational New Drug (IND) Application and Study Initiation Expected inFirst Half of 2023 --
-- $366.2 Million in Cash, Cash Equivalents and Investments as of September 30, 2022, Excluding Net Proceeds of Approximately $650.7 Million from Recent Public Offering --
SAN CARLOS, Calif., Nov. 07, 2022 (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 third quarter ended September 30, 2022 and provided a business update.
“We were thrilled to recently announce the positive results from our Phase 1/2 clinical proof-of-concept study, which demonstrated VAX-24 has the potential to provide broader coverage and better immune responses relative to the standard-of-care. These noteworthy findings validate the potential of our cell-free platform and carrier-sparing approach to enable the development of broader-spectrum PCVs,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We believe these results support a best-in-class potential for VAX-24 and present an opportunity to set a new bar for immunogenicity standards for pneumococcal vaccines.”
Mr. Pickering continued, “With the recent follow-on equity offering, which generated approximately $651 million in net proceeds, our balance sheet is further strengthened as we advance our pipeline of novel vaccines. We anticipate multiple VAX-24 milestones, including the topline results from a second Phase 2 study in older adults and the initiation of a Phase 2 study in infants, in the first half of 2023. Additionally, we are progressing VAX-XP, our PCV candidate with 31 strains of coverage, and expect to submit an adult IND application in the second half of 2023.”
Recent Highlights
Anticipated Key Milestones
Third Quarter 2022 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 pneumococcal conjugate vaccine 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 XpressCFTM 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-XP, a PCV with coverage of 31 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. 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 and submission of an IND application for 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-XP adult program and the timing and availability of the Phase 1/2 topline data for such program; the potential for VAX-XP to become the broadest-spectrum PCV; the timing of guidance for an IND application for VAX-A1; the timing of a nomination of a final vaccine candidate for VAX-PG; the demand for Vaxcyte’s vaccine candidates; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “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, without limitation, its Quarterly Report on Form 10-Q filed with the SEC on November 7, 2022 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.
(1) Lower bound of the 2-sided 95% confidence interval of the OPA geometric mean titer ratio is greater than 0.5.
(2) Lower bound of the 2-sided 95% confidence interval of the difference in the proportions of participants with a ≥4-fold increase from Day 1 to Day 29 is greater than 10%, and lower bound of the 2-sided 95% confidence interval of the OPA geometric mean titer ratio is greater than 2.0.
Contacts:
Andrew Guggenhime, President and Chief Financial Officer
Vaxcyte, Inc.
650-837-0111
investors@vaxcyte.com
Janet Graesser, Vice President, Corporate Communications and Investor Relations
Vaxcyte, Inc.
917-685-8799
media@vaxcyte.com Vaxcyte, Inc.Condensed Statements of Operations(in thousands, except share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Operating expenses: Research and development (1) $47,679 $20,428 $117,825 $55,337 General and administrative (1) 10,898 6,523 27,858 18,487 Total operating expenses 58,577 26,951 145,683 73,824 Loss from operations (58,577) (26,951) (145,683) (73,824)Other income (expense), net: Interest expense - - (2) (7)Interest income 1,190 90 1,723 245 Grant income 157 299 1,006 677 Realized gain on marketable securities - 1 - 2 Foreign currency transaction gains (losses) (687) (54) (2,479) 1,393 Total other income (expense), net 660 336 248 2,310 Net loss $(57,917) $(26,615) $(145,435) $(71,514) Net loss per share, basic and diluted $(0.93) $(0.51) $(2.42) $(1.39) Weighted-average shares outstanding, basic and diluted 61,989,347 52,187,303 60,166,583 51,627,249 (1) Amounts include stock-based compensation expense as follows: Research and development $2,682 $1,023 $6,804 $2,688 General and administrative 3,966 1,914 9,837 4,883 Total stock-based compensation expense $6,648 $2,937 $16,641 $7,571 Vaxcyte, Inc.Summary Balance Sheet Data(in thousands) September 30, December 31, 2022 2021 Cash, cash equivalents and investments $366,203 $273,087 Total assets 412,065 324,337 Total stockholders' equity 359,311 284,018