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Vaxcyte Reports Second Quarter 2021 Financial Results and Provides Business Update

Key Takeaway: Vaxcyte Reports Second Quarter 2021 Financial Results and Provides Business Update FOSTER CITY, Calif., August 11, 2021 - Vaxcyte, Inc. (Nasdaq: PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to preven

Full Press Release Details

Vaxcyte Reports Second Quarter 2021 Financial Results and Provides Business Update
FOSTER CITY, Calif., August 11, 2021 - Vaxcyte, Inc. (Nasdaq: PCVX), a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.
"The public health community continues to affirm the need for vaccines that can offer broader protection to prevent pneumococcal disease and, importantly, reach an expanded population including adults aged 50 and older as well as those at higher risk due to existing health conditions," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "We are focused on making a significant contribution to fulfill this need with VAX-24, our lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate, and VAX-XP, our PCV candidate with an expanded breadth of coverage."
Pickering continued, "We have made meaningful strides with VAX-24 in collaboration with Lonza, including the completion of the manufacturing and testing of the 24 conjugated drug substances (DS). We are well on our way to the final release of the DS and have now entered the final drug product (DP) formulation, fill and finish phase as we advance toward the anticipated submission of the Investigational New Drug (IND) application required to generate clinical proof-of-concept data."
Anticipated Key Milestones
Second Quarter 2021 Financial Results
Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. The Company's cell-free protein synthesis platform, comprising the XpressCFTM platform, exclusively licensed from Sutro Biopharma, Inc., together with Vaxcyte's proprietary know-how, enables the design and production of protein carriers and antigens, the critical building blocks of vaccines, in ways that the Company believes conventional vaccine technologies currently cannot. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Vaxcyte's pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 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 by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. 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 benefit of Vaxcyte's vaccine candidates; the process and timing of anticipated future development of Vaxcyte's vaccine candidates, including the timing and submission of an IND application for VAX-24 and the initiation of the VAX-24 Phase 1/2 clinical proof-of-concept study thereafter; the timing and availability of topline data for VAX-24; the ability to complete the manufacturing of the GMP drug product; the achievement of future funding milestones; the use and availability of funds from CARB-X; the initiation of IND-enabling activities for VAX-A1; the nomination of a final vaccine candidate for VAX-PG; the achievement of funding milestones; and other statements that are not historical fact. The words "believe," "could," "expect," "may," "potential," "should," "would" and similar expressions 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 11, 2021 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. 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.
Andrew Guggenhime, President and Chief Financial Officer
Janet Graesser, Vice President, Corporate Communications and Investor Relations
Vaxcyte, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 2021 2020
Operating expenses:
Research and development (1) $ 17,651 $ 18,178 $ 34,909 $ 42,493
General and administrative (1) 6,079 3,046 11,964 6,327
Total operating expenses 23,730 21,224 46,873 48,820
Loss from operations (23,730 ) (21,224 ) (46,873 ) (48,820 )
Other income (expense), net:
Interest expense (7 ) - (7 ) (7 )
Interest income 93 44 155 179
Grant income 378 1,036 378 1,365
Realized gain on marketable securities 1 - 1 -
Foreign currency transaction gains (losses) (414 ) (176 ) 1,447 (179 )
Total other income (expense), net 51 904 1,974 1,358
Net loss $ (23,679 ) $ (20,320 ) $ (44,899 ) $ (47,462 )
Net loss per share, basic and diluted $ (0.46 ) $ (1.72 ) $ (0.87 ) $ (5.99 )
Weighted-average shares outstanding, basic and diluted 51,508,340 11,803,778 51,342,585 7,926,818
(1) Amounts include stock-based compensation expense as follows:
Research and development $ 982 $ 374 $ 1,665 $ 523
General and administrative 1,787 915 2,969 1,138
Total stock-based compensation expense $ 2,769 $ 1,289 $ 4,634 $ 1,661
Vaxcyte, Inc.
Summary Consolidated Balance Sheet Data
(in thousands)
June 30, December 31,
2021 2020
Cash, cash equivalents and investments $ 340,951 $ 386,200
Total assets 358,054 392,826
Total stockholders' equity 317,025 345,843
Last updated: Aug 11, 2021