Vaxcyte Reports Third Quarter 2020 Financial Results and Provides Business Update
“Vaxcyte continues to make steady progress in executing on our business objectives,” said
Recent Highlights
- Advanced VAX-24 Manufacturing Activities:
Vaxcyte progressed several manufacturing initiatives for VAX-24, including for the good manufacturing practices (GMP) batches of the 24 polysaccharide antigens and the GMP batches of the 24 conjugate drug substances. - Appointed
Romulo Colindres , MD, MPH as Chief Medical Officer: InNovember 2020 ,Vaxcyte appointedRomulo Colindres , MD, MPH as Chief Medical Officer. Prior to joiningVaxcyte ,Dr. Colindres served in several roles at GlaxoSmithKline Vaccines and most recently served as an independent consultant and advisor to multiple biotechnology companies. FromMarch 2007 toMarch 2019 ,Dr. Colindres served in roles of increasing responsibility at GlaxoSmithKline, including Head of Health Outcomes for GSK Vaccines Latin America, Head of Global Epidemiology forGSK Vaccines and, most recently, Vice President, Global Medical Affairs Lead, Zoster Vaccine, leading the medical team in the successful launch of Shingrix®, a recombinant adjuvanted herpes zoster vaccine. Prior to that,Dr. Colindres worked at theCenters for Disease Control and Prevention (CDC ) as an Epidemic Intelligence Service Officer. He completed his residency at Children’sNational Medical Center inWashington, DC and was board certified in Pediatrics.Dr. Colindres received both his MD and MPH atThe University of North Carolina ,Chapel Hill , and his MBA from Duke University’sFuqua School of Business .
- Appointed
Suzanna Fekete , MSc as Vice President, Regulatory Affairs: InOctober 2020 ,Vaxcyte appointedSuzanna Fekete , MSc as Vice President, Regulatory Affairs. Prior to joiningVaxcyte ,Ms. Fekete served in roles of increasing responsibility atTakeda Vaccines since 2015, most recently as Vice President and Head, Global Regulatory Affairs.Ms. Fekete also served as Head, North American Regulatory Affairs at Novartis Vaccines and Diagnostics and held regulatory affairs leadership roles at multiple other pharmaceutical and biotechnology companies.Ms. Fekete received her MSc at theUniversity of Wales .
Anticipated Milestones
- VAX-24:
Vaxcyte expects to submit an Investigational New Drug (IND) application for VAX-24 to theU.S. Food and Drug Administration (FDA) and initiate its Phase 1/2 clinical proof-of-concept study in the second half of 2021.Vaxcyte expects to announce topline data from this study in 2022. - VAX-A1: In 2021,
Vaxcyte expects to nominate a final vaccine candidate for VAX-A1, its novel conjugate vaccine designed to provide universal protection from infections caused by Group A Strep bacteria, which include pharyngitis, toxic shock syndrome and necrotizing fasciitis. - VAX-PG: In 2021,
Vaxcyte expects to nominate a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease.
Third Quarter 2020 Financial Results
- Cash Position: Cash and cash equivalents were
$397.0 million as ofSeptember 30, 2020 , compared to$59.0 million as ofDecember 31, 2019 , an increase due to Vaxcyte’s IPO inJune 2020 and Series D financing inMarch 2020 , which generated net proceeds of$264.0 million and$109.9 million , respectively. - Research & Development (R&D) Expenses: R&D expenses were
$16.4 million for the three months endedSeptember 30, 2020 as compared to$9.6 million for the same period in 2019. The increase was due primarily to an increase in manufacturing expenses and outsourced research services related to the Company’s VAX-24 program. - General & Administrative (G&A) Expenses: G&A expenses were
$4.9 million for the three months endedSeptember 30, 2020 as compared to$2.5 million for the same period in 2019. The increase was due primarily to an increase in personnel-related and directors and officers insurance expenses. - Net Loss: For the three months ended
September 30, 2020 , net loss was$21.0 million , compared to$11.3 million for the three months endedSeptember 30, 2019 .
About
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 process and timing of anticipated future development of Vaxcyte’s vaccine candidates, including the submission of an IND and initiation of a Phase 1/2 study of VAX-24 in the second half of 2021 and the announcement of topline data in 2022; the nomination of a final vaccine candidate for VAX-A1 in 2021 and the nomination of a final vaccine candidate for VAX-PG in 2021. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “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
Investor Contact:
650-837-0111
[email protected]
Condensed Statements of Operations | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development (1) | $ | 16,410 | $ | 9,630 | $ | 58,903 | $ | 32,225 | ||||||||
General and administrative (1) | 4,898 | 2,510 | 11,225 | 6,089 | ||||||||||||
Total operating expenses | 21,308 | 12,140 | 70,128 | 38,314 | ||||||||||||
Loss from operations | (21,308 | ) | (12,140 | ) | (70,128 | ) | (38,314 | ) | ||||||||
Other income (expense), net | ||||||||||||||||
Interest expense | — | (9 | ) | (7 | ) | (33 | ) | |||||||||
Interest income | 33 | 120 | 212 | 537 | ||||||||||||
Grant income | 787 | 54 | 2,152 | 54 | ||||||||||||
Foreign currency transaction losses | (530 | ) | (186 | ) | (709 | ) | (417 | ) | ||||||||
Change in fair value of the redeemable convertible preferred stock tranche liability | — | 844 | — | 2,520 | ||||||||||||
Total other income (expense), net | 290 | 823 | 1,648 | 2,661 | ||||||||||||
Net loss and comprehensive loss | $ | (21,018 | ) | $ | (11,317 | ) | $ | (68,480 | ) | $ | (35,653 | ) | ||||
Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (2.93 | ) | $ | (3.06 | ) | $ | (9.54 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 50,895,358 | 3,857,298 | 22,354,212 | 3,737,779 | ||||||||||||
(1) Amounts include stock-based compensation expense as follows: | ||||||||||||||||
Research and development | $ | 558 | $ | 88 | $ | 1,081 | $ | 262 | ||||||||
General and administrative | 1,280 | 178 | 2,418 | 548 | ||||||||||||
Total stock-based compensation expense | $ | 1,838 | $ | 266 | $ | 3,499 | $ | 810 | ||||||||
Summary Consolidated Balance Sheet Data | ||||||||||||||||
(in thousands) | ||||||||||||||||
(unaudited) | ||||||||||||||||
2020 | 2019 | |||||||||||||||
Cash and cash equivalents | $ | 397,048 | $ | 58,976 | ||||||||||||
Total assets | 403,816 | 65,698 | ||||||||||||||
Redeemable convertible preferred stock | — | 160,310 | ||||||||||||||
Total stockholders' equity (deficit) | 364,075 | (106,373 | ) |
Source: Vaxcyte, Inc.