Full Press Release Details
Vaxcyte Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
FOSTER CITY, Calif., March 29, 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 fourth quarter and full year ended December 31, 2020 and provided a business update.
"The past year has been transformational for Vaxcyte and I am pleased with the multiple milestones we have achieved on the path to submit our Investigational New Drug (IND) application for VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), the progress of our other pipeline programs, and the addition of new leadership team members," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "While our team has completed several additional key steps to support the IND application submission for VAX-24, in light of the combination of ongoing work to manufacture the 24 conjugated drug substances, capacity constraints at our contract manufacturing organization and, to a lesser degree, the impact of the COVID-19 pandemic, we are changing the expected timing of our VAX-24 IND application submission to between January and June 2022."
Pickering continued, "As further confirmation of the progress of our pipeline vaccines and the potential benefits of our technology platform, we are today announcing new immunogenicity data for VAX-XP, our PCV candidate with an expanded breadth of coverage, and the final vaccine candidate nomination for VAX-A1."
Key 2020 and 2021 Highlights to Date
Anticipated Key Milestones
Fourth Quarter and Full Year 2020 Financial Results
Conference Call and Webcast
Vaxcyte will host a conference call and webcast to discuss this announcement today, March 29, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial (833) 519-1403 (domestic) or (270) 215-9736 (international) and refer to conference ID 1497487. A live audio webcast will be available in the Investors & Media section of the Company's website at www.vaxcyte.com. A replay of the webcast will be available for 30 days following the call.
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 are based on Vaxcyte's current beliefs and expectations. Such statements include, but are not limited to, statements related to: the preventative 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; the timing and availability of topline data for VAX-24; the initiation of IND-enabling activities for VAX-A1; the nomination of a final vaccine candidate for VAX-PG; and other statements that are not historical fact. 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; Vaxcyte's reliance on third-party manufacturers; 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; sufficiency of cash and other funding to support Vaxcyte's development programs and other operating expenses; and the ongoing COVID-19 pandemic, which could materially and adversely affect Vaxcyte's business and operations. These and other risks are described more fully in Vaxcyte's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on March 29, 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
| Vaxcyte, Inc. | ||||||||||||||||
| Condensed Statements of Operations | ||||||||||||||||
| (in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 14,661 | $ | 13,381 | $ | 73,564 | $ | 45,607 | ||||||||
| General and administrative (1) | 4,792 | 2,456 | 16,017 | 8,546 | ||||||||||||
| Total operating expenses | 19,453 | 15,837 | 89,581 | 54,153 | ||||||||||||
| Loss from operations | (19,453 | ) | (15,837 | ) | (89,581 | ) | (54,153 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Interest expense | - | (7 | ) | (7 | ) | (40 | ) | |||||||||
| Interest income | 32 | 94 | 244 | 632 | ||||||||||||
| Grant income | 326 | 184 | 2,478 | 237 | ||||||||||||
| Foreign currency transaction losses | (1,642 | ) | 280 | (2,351 | ) | (135 | ) | |||||||||
| Change in fair value of the redeemable convertible preferred stock tranche liability | - | 665 | - | 3,185 | ||||||||||||
| Total other income (expense), net | (1,284 | ) | 1,216 | 364 | 3,879 | |||||||||||
| Net loss and comprehensive loss | $ | (20,737 | ) | $ | (14,621 | ) | $ | (89,217 | ) | $ | (50,274 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (3.69 | ) | $ | (3.02 | ) | $ | (13.25 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 50,964,294 | 3,965,166 | 29,545,810 | 3,795,090 | ||||||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||||||
| Research and development | $ | 779 | $ | 106 | $ | 1,861 | $ | 368 | ||||||||
| General and administrative | 1,155 | 269 | 3,573 | 817 | ||||||||||||
| Total stock-based compensation expense | $ | 1,934 | $ | 375 | $ | 5,434 | $ | 1,185 | ||||||||
| Vaxcyte, Inc. | ||||||||||||||||
| Summary Balance Sheet Data | ||||||||||||||||
| (in thousands) | ||||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | |||||||||||||||
| Cash and cash equivalents | $ | 386,200 | $ | 58,976 | ||||||||||||
| Total assets | 392,826 | 65,698 | ||||||||||||||
| Redeemable convertible preferred stock | - | 160,310 | ||||||||||||||
| Total stockholders' equity (deficit) | 345,843 | (106,373 | ) |