0001633070 false 0001633070 2022-10-10
2022-10-10 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
October 10, 2022
AXCELLA HEALTH INC.
(Exact name of registrant as specified in its charter)
| Delaware |
|
001-38901 |
|
26-3321056 |
(State
or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification No.) |
840
Memorial Drive
Cambridge,
Massachusetts |
02139 |
| (Address
of principal executive offices) |
(Zip
Code) |
Registrant's telephone number, including area code
(857)
320-2200
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 or to be registered pursuant to Section 12(b)
of the Act.
|
Title
of each class |
|
Trading
symbol(s) |
|
Name
of each exchange
on which registered |
| Common
Stock, $0.001 par value |
|
AXLA |
|
Nasdaq
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 x
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
1.01 |
Entry
into a Material Definitive Agreement. |
On
October 13, 2022, Axcella Health Inc. (the “Company” or
“Axcella”), doing business as “Axcella Therapeutics”, entered into
a Securities Purchase Agreement (the “Purchase Agreement”) with the
purchasers named therein (the “Purchasers”). Pursuant to the
Purchase Agreement, the Company agreed to issue and sell in a
registered direct offering an aggregate of 20,847,888 shares of the
Company’s common stock, par value $0.001 per share (the “Common
Stock”), at a purchase price of $1.64 per share (the “Offering”).
Funds associated with existing investor Flagship Pioneering
are purchasing shares of Common Stock in the Offering, a portion of
such shares are being purchased in exchange for cancellation of
indebtedness upon the conversion of unsecured subordinated
convertible promissory notes pursuant to a securities purchase
agreement among us and such investors. The net proceeds to the
Company are expected to be approximately $34.1 million after
deducting estimated offering expenses payable by the Company,
including $6 million received as the cancellation of indebtedness
upon the conversion of certain unsecured subordinated convertible
promissory notes. The Company intends to use the net proceeds of
the Offering to advance its Long COVID program, including
regulatory engagement and preparation for further clinical
development; advance and complete enrollment of our EMMPACT Phase
2b clinical trial in non-alcoholic steatohepatitis (NASH); and for
working capital and other general corporate purposes. The Offering
is anticipated to close on or about October 13, 2022.
The Purchase Agreement contains customary representations,
warranties, and agreements by the Company, and customary
indemnification and other obligations of the Company and the
Purchasers. Pursuant to the terms of the Purchase Agreement, the
Company has also agreed to certain restrictions on the issuance and
sale of its securities until 60 days following the date of the
Purchase Agreement, subject to certain exceptions. Also, pursuant
to the terms of the Purchase Agreement, the Purchasers have certain
rights to participate in subsequent issuances of the Company’s
securities during the 6 month period following the date of the
Purchase Agreement, subject to certain exceptions.
The shares of Common Stock will be offered and sold by the Company
pursuant to an effective shelf registration statement on
Form S-3 (File No. 333-238983), which was originally
filed with the Securities and Exchange Commission on June 5,
2020, and was declared effective on June 12, 2020 (the
“Registration Statement”).
The foregoing summary of the Purchase Agreement is qualified in its
entirety by the full text of the Purchase Agreement, the form of
which is filed herewith as Exhibit 10.1 and incorporated
herein by reference. The form of Purchase Agreement is attached
hereto as an exhibit to provide investors and security holders with
information regarding its terms. It is not intended to provide any
other factual information about the Company. The representations,
warranties and covenants contained in the Purchase Agreement were
made only for purposes of the Purchase Agreement and as of specific
dates, were solely for the benefit of the parties to the Purchase
Agreement, and may be subject to limitations agreed upon by the
contracting parties.
A copy of the legal opinion of Goodwin Procter LLP, relating to the
validity of the shares issued in the Offering, is filed as
Exhibit 5.1 to this Current Report on Form 8-K and is
filed with reference to, and is hereby incorporated by reference
into, the Registration Statement.
| Item
5.02 |
Departure
of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of
Certain Officers. |
(b)
On October 10, 2022, David R. Epstein, a member of the board
of directors (the “Board”) of the Company, notified the Company of
his resignation from the Board, effective immediately.
Mr. Epstein’s resignation was not the result of a disagreement
with the Company on any matter relating to the Company’s
operations, policies or practices. Effective as of his resignation,
Dr. Epstein is no longer a member of the Board or any of its
committees.
Mr. Epstein will serve as a consultant to the Company until
July 1, 2024, unless earlier mutually terminated, pursuant to
a consulting agreement effective as of October 10, 2022
(the “Consulting Agreement”). As compensation for such
services, Mr. Epstein’s outstanding equity awards will
continue to vest while he continues to provide services as a
consultant to the Company and any vested portion of such awards
will remain exercisable for a period of one (1) year following
termination of the Consulting Agreement.
(d)
On October 10, 2022, upon the recommendation of its Nominating
and Corporate Governance Committee, the Board appointed Robert
Rosiello and Torben Straight Nissen to join the Board, effective
immediately. The Board determined that both Mr. Rosiello and
Mr. Straight Nissen are independent under the listing
standards of Nasdaq and the Company’s corporate governance
guidelines. Mr. Rosiello will serve as a Class III
director with a term expiring at the annual meeting of stockholders
to be held in 2025. Mr. Straight Nissen will serve as a
Class I director with a term expiring at the annual meeting of
stockholders to be held in 2023. Mr. Rosiello was also
appointed to serve as the Chairman of the Board, effective
immediately.
Mr. Rosiello is an Executive Partner at Flagship Pioneering,
where he focuses on building capability to help originate, manage,
and grow new Flagship companies, and working with senior leadership
to drive Flagship’s strategy, institution building, and growth
initiatives. He joined Flagship in January 2018. From
July 2015 to August 2016, Mr. Rosiello was both
Executive Vice President and Chief Financial Officer at Valeant
Pharmaceuticals International, Inc., where he led the finance,
human resources, and IT functions. Shortly after joining Valeant,
the company faced allegations that it had previously misstated its
financial and other disclosures. Mr. Rosiello led Valeant’s
financial restatement process acknowledging deficiencies and
regaining timely reporting status with the SEC. From
September 1984 to June 2015, Mr. Rosiello worked at
McKinsey & Company advising CEOs and boards of leading
health care, technology, and consumer companies. He served as a
senior partner for 18 years and was a member of McKinsey’s Senior
Partner Review and Compensation Committees. Mr. Rosiello led
the work that shifted McKinsey’s recruiting toward non-MBAs and
developed innovative leadership training for McKinsey’s senior
partners. He also led significant pro bono work for Save the
Children, Americares, Carnegie Corporation, and Fairfield
University. Mr. Rosiello currently serves on the Board and
Executive Committee of Catholic Charities of New York and the
Central Selection Committee of the Morehead-Cain Foundation.
He previously served on the Boards of the Pew Research Center and
Inari Agriculture. Mr. Rosiello received his B.A. in economics
from the University of North Carolina, where he was a Morehead
Scholar and graduated Phi Beta Kappa, an M.Sc. in economics from
the London School of Economics, and an M.B.A. from Harvard Business
School. We believe that Mr. Rosiello’s extensive business and
financial experience qualifies him to serve on our board of
directors.
Mr. Straight Nissen is a senior partner at Flagship
Pioneering, he joined Flagship in November 2016.
Mr. Straight Nissen served on the board of directors of Ring
Therapeutics, Inc. from August 2018 to December 2021
and since March 2021 has served as founding chief executive
officer of FL84 Inc. From November 2016 to July 2019, he
served as president of Rubius Therapeutics (NASDAQ:
RUBY), he also served on the board of directors of Rubius from
November 2016 to August 2018. From July 2011 to
November 2016 Mr. Straight Nissen held positions of
increasing responsibility at Pfizer, with his last position as Vice
President, heading up Pfizer’s Worldwide R&D Strategic
Portfolio Management. In this role, he oversaw Pfizer’s portfolio
spanning from discovery up to Phase 3 trials across multiple
therapeutic areas, including oncology, inflammation and immunology,
rare diseases, cardiovascular and metabolic disease, neuroscience,
and vaccines. Previously, he was responsible for the portfolio,
strategy and operations functions within Pfizer’s BioTherapeutics
Division and ensured efficient advancement of protein therapeutics,
cell therapies, gene therapies and vaccines from discovery through
development. He also served as chief operating officer for the
Centers for Therapeutic Innovation, a pioneering R&D unit
within Pfizer that drives product development partnerships with
world-leading academic medical centers. As COO, Mr. Straight
Nissen headed up that organization’s portfolio management, business
development, finance and operations functions, and he was one of
the key drivers behind establishing the unit. Prior to joining
Pfizer, Mr. Straight Nissen served as chief operating officer
at Ascendis Pharma (NASDAQ: ASND) from April 2008 to
June 2011, advancing the company’s portfolio of new,
innovative prodrugs from discovery to clinical proof-of-concept.
Earlier, Mr. Straight Nissen served in various leadership
positions at Maxygen, a molecular evolution and advanced protein
engineering company, including the role of managing director of
R&D and senior vice president of global project management. He
began his career at Novo Nordisk with a focus on protein
engineering. Mr. Straight Nissen holds a Ph.D. in molecular
biology and biochemical engineering from the Technical University
of Denmark and Carlsberg Laboratories and a Master of Science
degree in chemical engineering from the Technical University of
Denmark. We believe that Mr. Straight Nissen’s extensive
business and financial experience qualifies him to serve on our
board of directors.
As a non-employee director, each of Mr. Rosiello and
Mr. Straight Nissen will receive cash compensation and an
equity award for Board service in accordance with the Company’s
non-employee director compensation policy. Neither
Mr. Rosiello nor Mr. Straight Nissen is a party to any
transaction with the Company that would require disclosure under
Item 404(a) of Regulation S-K, and there are no arrangements
or understandings between either Mr. Rosiello or
Mr. Straight Nissen and any other persons pursuant to which
either was selected as a director. In addition, each of
Mr. Rosiello and Mr. Straight Nissen will enter into an
indemnification agreement with the Company consistent with the form
of indemnification agreement entered into between the Company and
its existing non-employee directors.
On October 13, 2022, the Company issued a press release
announcing the Offering and the changes to the Board, a copy of
which is attached hereto as Exhibit 99.1 and incorporated
herein by reference.
The Company is engaged with the FDA and a foreign regulatory body
with respect to the design of the next clinical trial of AXA1125
for the treatment of Long COVID, including the endpoints, number of
subjects and treatment duration. The Company expects to have
additional clarity regarding the future development path of AXA1125
for Long COVID by the end of 2022. The Company is making plans for
the next clinical trial that it tentatively expects to be initiated
in the first half of 2023.
|
Item
9.01. |
Financial
Statements and Exhibits. |
(d) Exhibits
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 hereunto duly authorized.
| |
AXCELLA
HEALTH INC. |
| |
|
| Date:
October 13, 2022 |
By: |
/s/
William R. Hinshaw, Jr. |
| |
|
William
R. Hinshaw, Jr. |
| |
|
President,
Chief Executive Officer and Director |
Axcella Health (NASDAQ:AXLA)
Historical Stock Chart
From May 2023 to Jun 2023
Axcella Health (NASDAQ:AXLA)
Historical Stock Chart
From Jun 2022 to Jun 2023
