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Vaxcyte(PCVX) - 2024 Q1 - Quarterly Results
2024-05-08 20:08
Exhibit 99.1 Vaxcyte Reports First Quarter 2024 Financial Results and Provides Business Update -- VAX-31 Adult Program Phase 1/2 Study Enrollment Completed; Topline Safety, Tolerability and Immunogenicity Data Expected in Third Quarter of 2024 -- PCV Franchise Infant Indication: -- Following VAX-31 Adult Phase 1/2 Study Readout, Vaxcyte to Advance VAX-24 or VAX-31 to Adult Phase 3 Program -- -- VAX-24 Infant Phase 2 Study Enrollment Completed; Topline Data from Primary Immunization Series Expected by End of ...
Vaxcyte(PCVX) - 2023 Q4 - Earnings Call Transcript
2024-02-28 05:32
Vaxcyte, Inc. (NASDAQ:PCVX) Q4 2023 Earnings Conference Call February 27, 2024 4:30 PM ET Company Participants Andrew Guggenhime - President and Chief Financial Officer Grant Pickering - Chief Executive Officer, Director and Founder Jim Wassil - Executive Vice President and Chief Operating Officer Conference Call Participants Jason Gerberry - Bank of America Roger Song - Jefferies Dave Risinger - Leerink Partners Umer Raffat - Evercore Seamus Fernandez - Guggenheim Louise Chen - Cantor Fitzgerald Joseph Str ...
Vaxcyte(PCVX) - 2023 Q4 - Earnings Call Presentation
2024-02-28 03:26
February 27, 2024 Forward-Looking Statements 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 ...
Vaxcyte(PCVX) - 2023 Q4 - Annual Report
2024-02-27 21:12
FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ___________ Commission File Number 001-39323 VAXCYTE, INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of inco ...
Vaxcyte(PCVX) - 2023 Q4 - Annual Results
2024-02-27 21:02
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 V ...
Vaxcyte(PCVX) - 2023 Q3 - Quarterly Report
2023-11-06 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39323 VAXCYTE, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdi ...
Vaxcyte(PCVX) - 2023 Q2 - Quarterly Report
2023-08-08 20:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39323 VAXCYTE, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction ...
Vaxcyte(PCVX) - 2023 Q1 - Quarterly Report
2023-05-08 20:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39323 VAXCYTE, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdictio ...
Vaxcyte(PCVX) - 2022 Q4 - Earnings Call Presentation
2023-02-28 03:04
| --- | --- | --- | --- | --- | |---------------------------------------|-------|-------|-------|-------| | | | | | | | 4Q & FY 2022 | | | | | | Financial Results and Business Update | | | | | | | | | | | February 27, 2023 VAXCYTE Forward-Looking Statements This presentation 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 Vaxcyte's vaccine candidat ...
Vaxcyte(PCVX) - 2022 Q4 - Earnings Call Transcript
2023-02-28 03:03
Financial Data and Key Metrics Changes - The company ended 2022 with $957.9 million in cash, cash equivalents, and investments, providing a strong financial position to fund upcoming milestones [33][71] - A significant increase in R&D expenses is expected in 2023, primarily due to investments in clinical trial materials for the VAX-24 Phase 3 program [19][70] Business Line Data and Key Metrics Changes - VAX-24, the lead pneumococcal conjugate vaccine (PCV), has shown potential to provide an additional 10% to 28% protection for adults compared to standard PCVs [9] - VAX-31, a 31-valent PCV candidate, aims to cover approximately 95% of circulating invasive pneumococcal disease (IPD) in the U.S. adult population [14][83] Market Data and Key Metrics Changes - The U.S. adult PCV market is approximately $2 billion of the total $7 billion global market, expected to be the fastest-growing segment [31] - The infant cohort represents the largest portion of the global pneumococcal vaccine market, with approximately $5 billion in annual sales [117] Company Strategy and Development Direction - The company is focused on advancing both VAX-24 and VAX-31, with several upcoming milestones, including a Phase 3 study for VAX-24 expected to deliver data in 2025 [11][19] - The strategic relationship with Lonza is emphasized to support potential launches and manufacturing needs for VAX-24 and VAX-31 [7][100] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ability to execute and scale the business in 2023 and beyond, highlighting the importance of their unique carrier-sparing technology [29][122] - The company is well-positioned to address the public health need for broader spectrum vaccines to prevent invasive disease [34][119] Other Important Information - The company has achieved a breakthrough therapy designation for VAX-24 in adults, adding to its fast-track designation [4] - The company plans to initiate a Phase 2 study for VAX-24 in infants in the second quarter of this year [37][117] Q&A Session Summary Question: Thoughts on the biggest risk in translating vaccine efficacy to the pediatric population - Management noted a strong historical consistency in vaccine efficacy across age groups, indicating confidence in the translatability of VAX-24 [46][47] Question: Level of point estimate needed for Phase 3 non-inferiority - Management indicated that a point estimate of around 0.6 is typically needed to meet non-inferiority standards, with confidence in achieving this based on prior data [50][52] Question: Plans for Phase 3 in infants versus PCV20 - Management confirmed that the initial Phase 2 study will compare VAX-24 to PCV15, with potential adjustments based on future recommendations from the FDA and ACIP [57][58] Question: Insights on VAX-31 and IND submission - Management confirmed plans to submit the IND for VAX-31 in the second half of the year, with expectations for rapid data accrual and readout [61][100] Question: Importance of being first to market with VAX-24 - Management highlighted that VAX-24's covalent bond technology provides a significant advantage over competitors, positioning it for an earlier market entry [95][110]