false 0001851657 NASDAQ 0001851657 2023-07-26 2023-07-26
Washington, D.C. 20549
Date of Report (Date of earliest event reported):
July 27, 2023
Vaxxinity, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
(IRS Employer
of incorporation)
File Number)
Identification No.)
505 Odyssey Way
Merritt Island
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number,
including area code: (
Not Applicable
(Former name or former address, if changed since last report)
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:
Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange
on which registered
Class A Common Stock, par value $0.0001
per share
Global Market
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
complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
Item 4.01. Changes in Registrant’s Certifying
On July 21, 2023, Vaxxinity,
Inc. (the “Company”) was informed by Armanino LLP (“Armanino”) that it intends
to resign as the
Company’s independent registered
public accounting firm, effective upon the earlier of (i) filing of
the Company’s Quarterly Report
on Form 10-Q for the quarter ending September 30, 2023 and (ii) the Company’s
appointment of a new independent registered public
accounting firm. The audit committee of the Company’s
board of directors accepted but did not request or recommend Armanino’s
Armanino advised the Company that its decision was due to Armanino’s
transition away from providing financial statement audit
services to public companies.
Armanino’s audit reports on
the Company’s consolidated financial
statements for the years ended December 31, 2022 and 2021 do not
contain any adverse opinion or disclaimer of opinion and were not qualified
or modified as to uncertainty, audit scope,
or accounting
principles. During the two most recent fiscal years and the subsequent interim period,
there were no (i) disagreements with Armanino
on any matter of accounting principles or practices, financial statement disclosure,
or auditing scope or procedure, which
disagreements, if not resolved to the satisfaction of Armanino, would have
caused it to make reference to the subject matter of the
disagreements in connection with its report or (ii) “reportable events” as such
term is defined in Item 304(a)(1)(v) of Regulation S-K.
The Company provided Armanino with a copy of the disclosures contained
in this Current Report on Form 8-K and requested that
Armanino furnish a letter addressed to the U.S. Securities and Exchange
Commission stating whether or not it agrees with the
statements made in this Current Report on Form 8-K, a copy of which is attached
as Exhibit 16.1 hereto.
The Company has begun a search process to identify a new independent registered
public accounting firm. There can be no assurance
that we will be able to appoint a new independent registered public accounting
firm on a timely basis, which would result in our
inability to file required Exchange Act reports, limit our ability to raise capital,
and result in a loss of investor confidence.
Item 5.02. Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers;
Arrangements of Certain Officers.
The information regarding Ulo Palm contained in Item 8.01 of this Current
Report on Form 8-K is incorporated by reference into this
Item 5.02.
Item 8.01. Other Events.
On July 27, 2023, the Company announced that Peter Powchik will join its leadership
team as Executive Vice President, Global
Scientific Director, effective
October 1, 2023. He will remain as a member of the Company’s
board of directors. In addition, the
Company announced that Ulo Palm
will transition from the Company’s
Chief Medical Officer to senior advisor,
effective October 1,
In connection with the foregoing matters, the Company issued a press release,
a copy of which is attached as Exhibit 99.1 to this
Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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 hereunto duly authorized.
Date: July 27, 2023
/s/ Jason Pesile
Jason Pesile
Senior Vice President, Finance &
Exhibit 16.1
July 26, 2023
U.S. Securities and Exchange Commission
100 F Street, NE
D.C. 20549
We have read
Inc.’s statements included in Item 4.01
of its Current Report Form 8-K dated July 26, 2023
and agree with those statements concerning our firm. We
have no basis to agree or disagree with other statements of
the registrant contained therein.
/s/ Armanino LLP
Appoints Peter Powchik,
M.D., to Executive
Global Scientific Director
Appointment adds Dr. Powchik’s
experience in the development of marketed immunotherapeutics to
Vaxxinity’s leadership team
CAPE CANAVERAL, Fla., July 27, 2023 -- Vaxxinity,
Inc. (Nasdaq:
), a U.S. company pioneering the
development of a new class of medicines,
announced that Peter Powchik, M.D. will join Vaxxinity’s
leadership team as Executive Vice President,
Global Scientific Director starting October 1, 2023.
He will
remain as a member of Vaxxinity’s board of directors.
Peter will oversee the overall scientific direction of our platform and programs, and lead the
development efforts at Vaxxinity.
“Get ready
for the next wave of innovative drug science at Vaxxinity
said Mei Mei Hu, CEO of Vaxxinity. “Peter
has served an integral role on Vaxxinity’s board of directors,
and we now get the benefit of his extensive knowledge and experience around the development of
breakthrough medicines on an even deeper level as he transitions to our leadership team.”
“It’s a pivotal time at Vaxxinity,”
said Peter Powchik. “Our laboratories have come online and are
generating the data that we hope will help launch a revolution in proactive immunization. Clinical data
have demonstrated that our technology breaks immune tolerance to targets of interest,
and is well
tolerated and easy to administer.
I am excited to help lead Vaxxinity’s development efforts
We have great people,
and I am certain the next years will be transformative to Vaxxinity and
to how the world sees the potential for immunotherapy to improve human health and well-being.”
Prior to joining Vaxxinity and its predecessor United Neuroscience, Peter was Senior Vice President,
Head of Clinical Development at Regeneron Pharmaceuticals from 2006 to 2018, where he oversaw the
development of Regeneron’s first
seven approved drugs and helped to build its development and
regulatory infrastructure. Peter led the development of multiple products to licensure including Eylea®,
Kevzara®, Arcalyst®, Dupixent®
and Praluent® against PCSK9 for hypercholesterolemia. He also served
various roles in clinical development including at Chugai Pharma USA, Novartis overseeing the
development and approval of Ritalin LA® and Focalin®, and Sepracor where he initiated the
development of Lunesta®. He is a board-certified psychiatrist trained at NYU School of Medicine, Mount
Sinai Medical Center (NYC), and Columbia University College of Physicians and Surgeons.
Ulo Palm, M.D. will transition from Chief Medical Officer of Vaxxinity to senior advisor effective
1, 2023.
“We are deeply grateful to Ulo for his time and enormous contributions to Vaxxinity,”
said Mei
Mei. “Under his guidance, Vaxxinity brought two new programs to the clinic and successfully completed
a Phase 3 COVID-19 trial and Phase 1 Parkinson’s disease trial.
We look forward to continuing to work
with Ulo and to benefit from his expertise in his role as an advisor to Vaxxinity.”
About Vaxxinity
Inc. is a purpose-driven biotechnology company committed to democratizing healthcare
across the globe. The company is pioneering a new class of medicines aimed at disrupting
the existing
treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer
from prohibitive costs and cumbersome administration. The company’s proprietary technology platform
has enabled the innovation of novel synthetic peptide immunotherapy candidates designed to bring the
efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s disease, Parkinson’s
disease, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19
vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on
human health.
For more information about Vaxxinity,
Inc., visit
and follow us on social media
Forward-looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. The use of certain words, including "believe," "may," "continue,"
"advancing," "will" and similar expressions, are intended to identify forward-looking statements.
Forward-looking statements include statements, other than statements of historical
fact, regarding,
among other things: the plans for, or progress, scope, initiation, duration, enrollment, results or timing
for availability of results of, development of any
of Vaxxinity’s product candidates
or programs, including
timing of the data readouts of UB-313 and VXX-401, and completion of the Phase
3 trial of UB-612; the
target indication(s) for development or approval, the size, design, population, location, conduct, cost,
objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or
completion of or availability or reporting of results from any clinical trial; the potential future regulatory
authorization or approval and commercialization of Vaxxinity’s
product candidates; the potential
benefits or competitive position of any Vaxxinity product candidate or program or the commercial
opportunity in any target indication; and Vaxxinity’s
plans, expectations or future operations, financial
position, revenues, costs or expenses. These forward-looking statements involve substantial
risks and
uncertainties, including statements that are based on the current expectations and assumptions of
Vaxxinity’s management about the development of a new class of immunotherapeutic vaccines and the
innovation and efficacy of Vaxxinity’s
product candidates. Various important factors could
cause actual
results or events to differ materially from those that may be expressed or implied by our forward-
looking statements, including, but not limited to: whether UB-312, UB-313, VXX-401, UB-612 or any
other current or future product candidate of Vaxxinity will be approved or authorized by any regulatory
agency for the indications that Vaxxinity targets; any
potential negative impacts of the COVID-19
pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of
Vaxxinity’s business; Vaxxinity’s
product candidates may not be successful or clinical development may
take longer and be more costly than anticipated; product candidates that appeared promising in earlier
research and clinical trials may not demonstrate safety or efficacy in larger-scale or later clinical trials or
in clinical trials for other indications; the timing for initiation or completion of, or for availability of data
from, clinical trials for UB-312, UB-313, VXX-401 or UB-612, and the outcomes of such trials; Vaxxinity’s
reliance on collaborative partners and other third parties for development of its product candidates;
Vaxxinity’s ability to obtain coverage,
pricing or reimbursement for any approved products and
acceptance from patients and physicians for any approved indications; delays or other challenges in the
recruitment of patients for,
or the conduct of, Vaxxinity’s
clinical trials; challenges associated with
supply and manufacturing activities; and Vaxxinity’s accounting policies. These and other important
factors to be considered in connection with forward-looking statements are described in the "Risk
Factors" section of Vaxxinity’s
Annual Report on Form 10-K filed with the U.S. Securities and Exchange
Commission on March 27, 2023. The forward-looking statements are made as of this date and Vaxxinity
does not undertake any obligation to update any forward-looking statements,
whether as a result of
new information, future events or otherwise, except as required by law.
Investor Contact
Mark Joinnides
Press Contact
Jon Yu