Form 8-K Vaxcyte, Inc. For: Aug 08
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2022, Vaxcyte, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2022. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 and Item 9.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: |
August 8, 2022 |
By: |
/s/ Andrew Guggenhime |
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Andrew Guggenhime |
Exhibit 99.1
Vaxcyte Reports Second Quarter 2022 Financial Results and Provides Business Update
-- Completed Enrollment of Phase 2 Portion of Phase 1/2 Clinical Proof-of-Concept Study Evaluating Safety, Tolerability and Immunogenicity of VAX-24 in Adults --
-- Announcement of Topline Results from the Phase 1 and Phase 2 Portions of the VAX-24 Proof-of-Concept Study Expected in October or November 2022 --
-- First Participants Dosed in Separate VAX-24 Phase 2 Clinical Study in Adults 65 Years and Older, with Topline Data Expected in the First Half of 2023 --
-- Received FDA Fast Track Designation for VAX-24 in Adults --
-- Completed Successful Pre-IND Meeting with FDA Regarding VAX-24 Pediatric Program, Supporting Path to Proceed Directly into Infants --
--$361.4 Million in Cash, Cash Equivalents and Investments as of June 30, 2022 --
SAN CARLOS, Calif., August 8, 2022 – 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 second quarter ended June 30, 2022 and provided a business update.
“Completing enrollment of the Phase 2 portion of our clinical proof-of-concept study in adults is a significant milestone in the advancement of VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), putting us on track to announce the topline safety, tolerability and immunogenicity results, versus the standard-of-care, in October or November of this year,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We expect this study, if successful, to be a driver of further activity across our PCV franchise, including the initiation of a VAX-24 study in infants and advancement of VAX-XP, our PCV candidate with an expanded breadth of coverage of greater than 30 strains.”
Mr. Pickering continued, “We believe the positive feedback from the FDA regarding both the adult and pediatric VAX-24 clinical programs, including receiving Fast Track designation in adults, supports an expedited path to deliver the broadest-spectrum PCV designed to prevent this serious disease. With significant upcoming milestones for the VAX-24 program, as well as across our pipeline, we expect continued, meaningful progress in the coming months.”
Recent Highlights
Anticipated Key Milestones
Second 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 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 XpressCF™ 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 an expanded breadth of coverage of greater than 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. 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 improvement upon the standard-of-care, the ability to deliver a potentially best-in-class PCV and the achievement of clinical proof-of-concept; the process and timing of anticipated future development, milestones and momentum of Vaxcyte’s vaccine candidates; the timing, availability and outcome of topline data for the VAX-24 Phase 1/2 clinical proof-of-concept study and Phase 2 clinical study; the demand for Vaxcyte’s vaccine candidates; and other statements that are not historical fact. The words “believe,” “could,” “expect,” “may,” “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 August 8, 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.
# # #
Contacts:
Andrew Guggenhime, President and Chief Financial Officer
Vaxcyte, Inc.
650-837-0111
Janet Graesser, Vice President, Corporate Communications and Investor Relations
Vaxcyte, Inc.
917-685-8799
Vaxcyte, Inc. |
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Condensed Statements of Operations |
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(in thousands, except share and per share amounts) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development (1) |
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$ |
38,469 |
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$ |
17,651 |
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$ |
70,147 |
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$ |
34,909 |
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General and administrative (1) |
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9,417 |
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6,079 |
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16,960 |
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11,964 |
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Total operating expenses |
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47,886 |
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23,730 |
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87,107 |
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46,873 |
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Loss from operations |
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(47,886 |
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(23,730 |
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(87,107 |
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(46,873 |
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Other income (expense), net: |
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Interest expense |
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(2 |
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(7 |
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(2 |
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(7 |
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Interest income |
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399 |
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93 |
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533 |
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155 |
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Grant income |
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690 |
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378 |
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850 |
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378 |
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Realized gain on marketable securities |
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— |
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1 |
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— |
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1 |
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Foreign currency transaction gains (losses) |
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(1,733 |
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(414 |
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(1,792 |
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1,447 |
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Total other income (expense), net |
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(646 |
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51 |
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(411 |
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1,974 |
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Net loss |
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$ |
(48,532 |
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$ |
(23,679 |
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$ |
(87,518 |
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$ |
(44,899 |
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Net loss per share, basic and diluted |
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$ |
(0.80 |
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$ |
(0.46 |
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$ |
(1.48 |
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$ |
(0.87 |
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Weighted-average shares outstanding, basic and diluted |
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60,818,778 |
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51,508,340 |
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59,192,182 |
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51,342,585 |
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(1) Amounts include stock-based compensation expense as follows: |
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Research and development |
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$ |
2,347 |
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$ |
982 |
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$ |
4,122 |
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$ |
1,665 |
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General and administrative |
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3,547 |
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1,787 |
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5,871 |
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2,969 |
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Total stock-based compensation expense |
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$ |
5,894 |
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$ |
2,769 |
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$ |
9,993 |
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$ |
4,634 |
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Vaxcyte, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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June 30, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and investments |
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$ |
361,361 |
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$ |
273,087 |
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Total assets |
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411,619 |
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324,337 |
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Total stockholders' equity |
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366,500 |
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284,018 |
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