Recommends Stockholders Vote "FOR" Proposed
Merger with Tarveda
Organovo Holdings, Inc. (“Organovo”) (NASDAQ: ONVO) today
announced that it has filed definitive proxy materials with the
U.S. Securities and Exchange Commission and has mailed these
materials and a letter to its stockholders in connection with the
company’s Special Meeting to be held on March 26, 2020.
Stockholders of record as of February 14, 2020 will be entitled to
vote at the meeting.
Organovo urges its stockholders to vote “FOR” the proposed
merger with Tarveda Therapeutics, Inc. (“Tarveda”), the proposed
reverse stock split and the other proposals outlined in the
definitive proxy statement. After carefully conducting a thorough
review of strategic alternatives, the Organovo Board of Directors
and management determined that the proposed merger with Tarveda
provides the best path forward for the Organovo stockholders to
maximize return on their investment.
The full text of Organovo’s letter to stockholders is as
follows:
Dear Fellow Stockholders,
As most of you are aware, the past year has been challenging for
Organovo. Throughout it all, the Board of Directors and management
team have been sharply focused on identifying the best path to
maximize value for you, our stockholders. In that spirit, I’m
reaching out to you today to encourage you to read the definitive
proxy statement/prospectus/information statement that was mailed to
you on or around February 26, 2020, and to vote in support of the
proposed merger with Tarveda Therapeutics, Inc. and the other
proposals described in the definitive proxy
statement/prospectus/information statement – which we believe
provides the best opportunity to maximize value for our
stockholders.
As a stockholder of record as of February 14, 2020, I ask you to
consider carefully the Board’s recommendation to:
1) Authorize the merger with Tarveda by
approving the issuance of Organovo’s common stock to the Tarveda
securityholders in accordance with the terms of the merger
agreement; 2) Vote in favor of the proposed reverse stock split by
approving an amendment to the Organovo certificate of incorporation
(in order to maintain our Nasdaq listing, and to allow us to have
sufficient shares of common stock to issue to the Tarveda
securityholders); and 3) Vote in favor of the other items outlined
in the definitive proxy statement/prospectus/information
statement.
Your vote is very important, no matter how many shares you own.
Please help us keep your company moving forward and support the
Tarveda transaction and the other items outlined in the definitive
proxy statement/prospectus/information statement by voting
today.
Please follow the instructions on the proxy card you receive
with the definitive proxy statement/prospectus/information
statement to vote by telephone or Internet or sign, date and return
the proxy card in the postage-paid envelope provided.
The Tarveda Opportunity
There continues to be a positive and receptive market for
clinical stage biotech companies with robust technology platforms
offering promising therapeutics in human clinical testing,
particularly in the rapidly evolving field of cancer therapeutics.
Against this backdrop, Organovo’s Board and management team
evaluated multiple opportunities to identify transactions that
could maximize the value of our tangible and intangible assets,
including our cash and public company profile, in order to provide
our stockholders potential for growth and value.
We believe we found the right partner in Tarveda. Tarveda is a
Boston-based, clinical stage biopharmaceutical company, developing
a new class of potent and selective precision oncology medicines,
referred to as Pentarin miniature drug conjugates. Pentarin
miniature drug conjugates consist of three parts:
1) A tumor targeting component called a
targeting moiety, which is typically a small molecule or peptide
that binds to a target that is differentiated in tumor compared to
normal tissue; 2) A potent anti-cancer payload that can kill tumor
cells; and 3) An optimized linker that joins the targeting agent
and the anti-cancer payload together.
Tarveda designs and develops its Pentarin miniature drug
conjugates to penetrate solid tumors, selectively bind to the
desired tumor targets, and accumulate the anti-cancer payloads
directly in tumor cells. Tarveda is supported by a strong syndicate
of investors including Novo Holdings A/S, Versant Ventures and ND
Capital (NanoDimension), and a highly seasoned management team with
prior public company experience.
Furthermore:
- Tarveda has two product candidates, PEN-866 and PEN-221, in
human clinical trials with on-going safety and efficacy data
generated from multiple patient cohorts in a range of solid tumor
indications. We believe that Tarveda also has a defined path to
multiple clinical data read-outs over the next two years.
- Tarveda’s Heat Shock Protein 90 (HSP90) binding miniature drug
conjugate platform is an impressive, proprietary discovery platform
off of which PEN-866 is the first miniature drug conjugate in the
clinic, but which also includes programs in discovery designed to
carry kinase inhibitors, radioisotopes, and other anti-cancer
payloads to accumulate and release those payloads in solid
tumors.
- Tarveda’s clinical and preclinical programs have had data in
peer-reviewed presentations and publications, including recent
presentations at ESMO and ASCO.
- Tarveda has recently raised additional capital that along with
Organovo’s anticipated cash at close is expected to provide
approximately $35 million of combined funding and can fund the
business into the second half of 2021. This funding is expected to
be sufficient to achieve key upcoming clinical data milestones on
both of Tarveda’s current clinical programs and additional
advancements from its HSP90 binding miniature drug conjugate
platform.
Organovo’s Strategic Alternatives Process
While we believe the Tarveda transaction is the right
transaction for Organovo stockholders, it’s also important that you
understand how we arrived at this decision.
Organovo began 2019 with three fundamental goals:
- Advancing our lead 3D bioprinted liver tissue therapeutics
program toward pre-Investigational New Drug (IND) and IND
registrational status;
- Driving value and generating positive cash flow from our
commercial businesses, grants, and partnering of other pipeline
assets; and
- Financing Organovo’s research-intensive efforts to achieve
these objectives.
Unfortunately, as we examined the data from broad animal studies
with our liver patches and other efforts, our management team, the
Board and our many external expert advisors determined that we had
not generated sufficiently compelling scientific data supporting
the requisite long-term functionality and benefit of our lead
therapeutic liver tissue candidate. We came to the very difficult
conclusion that the redevelopment necessary to make our tissues
commercially viable would require an inordinate amount of time,
financial investment and development risk, and was unlikely to
provide our existing stockholders with a sufficient return on
capital.
Accordingly, we initiated a process to evaluate a full
complement of strategic alternatives and find a new way forward
that could maximize stockholder return. During this thorough and
broad strategic alternatives process, we evaluated M&A,
licensing, co-development, and other strategies across a broad
spectrum of companies including: 1) major pharmaceutical companies
who were clients or partners; 2) leading life science, biotech, 3D
bio-printing, and regenerative medicine companies; and 3) private
and public biotechnology companies with clinical stage pipelines
and products, platform technologies or commercial products.
We negotiated confidentiality and standstill agreements and
commenced the due diligence process with 51 of these companies. Of
these, 49 were sent bid process instructions and 27 submitted
non-binding indications of interest. We evaluated all 27 companies
based on their submissions, data room documentation and external
reviews, and ultimately selected 8 companies to present detailed
presentations to the Special Committee of our Board of Directors.
The definitive proxy statement/prospectus/information statement
provides additional detail on the extensive efforts we undertook as
we examined every aspect of our business and explored strategic
alternatives to maximize stockholder value.
At the conclusion of this rigorous strategic alternatives review
process, our Board determined that a merger with Tarveda was the
best opportunity to maximize value for our stockholders. The Board
firmly believes that the merger with Tarveda is the best path
forward because of Tarveda’s disruptive HSP90 binding miniature
drug conjugate platform, which has already resulted in the PEN-866
clinical program and for which new conjugates with anti-cancer
payloads are in preclinical testing, the fact it has two product
candidates, PEN-866 and PEN-221 in human clinical trials, and
importantly, we believe Tarveda has a defined path to several
clinical data read-outs over the next two years.
For these reasons, the merger with Tarveda will create a more
advanced biotech company providing you, as a stockholder of
Organovo, with the opportunity to participate in a venture that
could have a substantial impact on oncology medicine and generate
stockholder returns in the future. We recommend strongly that our
stockholders support the merger with Tarveda and the other matters
discussed in the definitive proxy statement/prospectus/information
statement.
Your vote is important. Please support the merger with Tarveda
by voting today. Please follow the instructions on the proxy card
you receive with the definitive proxy
statement/prospectus/information statement to vote by telephone or
Internet or sign, date and return the proxy card in the
postage-paid envelope.
We thank all our stockholders for their continued support and
hope that together with Tarveda, we will make 2020 a transformative
year for the combined company.
Sincerely,
Taylor J. Crouch
Chief Executive Officer and President
About Organovo
Organovo has been a pioneer in the development of 3-D bioprinted
tissues comprised of human cells. After Organovo concluded that it
had not generated decisive scientific data supporting the prolonged
functionality and therapeutic benefit of its lead therapeutic liver
tissue candidate, Organovo implemented a restructuring plan to
significantly reduce expenses in order to focus on evaluating
strategic alternatives, while retaining certain key management, IP,
licenses, collaborations, and proprietary equipment.
Forward-Looking Statements
This communication contains forward-looking statements
(including within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended) concerning Organovo and Tarveda, the
proposed merger, Tarveda’s technology and product candidates and
Tarveda’s business and product development plans. These statements
may discuss goals, intentions and expectations as to future plans,
trends, events, results of operations or financial condition, or
otherwise based on current beliefs of the management of Organovo
and Tarveda, as well as assumptions made by, and information
currently available to, the respective management teams.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as “may,” “will,” “should,”
“would,” “expect,” “anticipate,” “plan,” “likely,” “believe,”
“estimate,” “project,” “intend,” and other similar expressions.
Statements that are not historical facts are forward-looking
statements. Forward-looking statements are based on current beliefs
and assumptions that are subject to risks and uncertainties and are
not guarantees of future performance. Actual results could differ
materially from those contained in any forward-looking statement as
a result of various factors, including, without limitation: the
risk that the conditions to the closing of the proposed merger are
not satisfied, including the failure to obtain stockholder approval
for the merger and the related proposals in a timely manner or at
all; uncertainties as to the timing of the consummation of the
proposed merger and the ability of each of Organovo and Tarveda to
consummate the transaction; risks related to Organovo’s continued
listing on The Nasdaq Capital Market until closing of the proposed
merger and the ability of the combined company to maintain its
listing if the transaction is consummated; risks related to the
ability of Organovo and Tarveda to correctly estimate their
respective operating expenses, the expenses associated with the
proposed merger and their net cash as of the closing of the
transaction; the risk that as a result of adjustments to the
exchange ratio, Organovo stockholders and Tarveda stockholders
could own more or less of the combined company than is currently
anticipated; unexpected costs, charges or expenses resulting from
the proposed merger; potential adverse reactions or changes to
business relationships resulting from the announcement or
completion of the proposed merger; Tarveda has incurred significant
net losses since inception and anticipates that it will continue to
incur substantial net losses for the foreseeable future and may
never achieve or maintain profitability; even after completion of
the merger, Tarveda will require substantial additional funding to
finance its operations and product development plans; Tarveda is
early in its development efforts and its lead drug candidates,
PEN-866 and PEN-221 are still in early stage clinical development
and there is no assurance that Tarveda will successfully complete
late stage clinical trials or ever obtain regulatory approval for
any drug candidate; Tarveda’s approach to the discovery and
development of Pentarin miniature drug conjugates, including using
its HSP90 binding miniature drug conjugate platform, is based on
novel technologies that are unproven and may not result in
marketable products; and other factors discussed in the risk
factors included in Organovo’s definitive proxy
statement/prospectus/information statement, filed with the
Securities and Exchange Commission (the “SEC”) on February 24,
2020, and its most recent Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q and Current Reports on Form 8-K filed with the
SEC. In addition, the forward-looking statements included in this
communication represent Organovo’s and Tarveda’s views as of the
date hereof. Organovo and Tarveda anticipate that subsequent events
and developments will cause their respective views to change.
However, while Organovo and Tarveda may elect to update these
forward-looking statements at some point in the future, Organovo
and Tarveda specifically disclaim any obligation to do so. These
forward-looking statements should not be relied upon as
representing Organovo’s or Tarveda’s views as of any date
subsequent to the date hereof.
Important Information and Where to Find It
This communication may be deemed to be solicitation material in
respect to the proposed transaction between Organovo and Tarveda.
On February 24, 2020, Organovo filed a definitive proxy
statement/prospectus/information statement with the SEC. Organovo
mailed the definitive proxy statement/prospectus/information
statement to its stockholders on or about February 26, 2020. Each
party may file other documents with the SEC in connection with the
proposed merger. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION,
INVESTORS AND STOCKHOLDERS ARE URGED TO READ THESE MATERIALS
CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT
INFORMATION ABOUT ORGANOVO, TARVEDA THE PROPOSED MERGER AND RELATED
MATTERS. Investors and stockholders may obtain, free of charge,
copies of the definitive proxy statement/prospectus/information
statement and any other documents filed by Organovo with the SEC in
connection with the proposed transactions at the SEC’s website
(http://www.sec.gov) and on the investor relations section of
Organovo’s website at ir.organovo.com. Investors and stockholders
are urged to read the definitive proxy
statement/prospectus/information statement and the other relevant
materials before making any voting or investment decision with
respect to the proposed merger and the related proposals.
Non-Solicitation
This communication does not constitute an offer to sell or
solicitation of an offer to buy any securities, nor will there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such
jurisdiction.
Participants in the Solicitation
Organovo and its directors and executive officers and Tarveda
and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Organovo in connection with the proposed merger. Information
regarding the special interests of the Organovo and Tarveda
directors and executive officers in the proposed merger is included
in the definitive proxy statement/prospectus/information statement
referred to above. Additional information regarding the directors
and executive officers of Organovo is included in Organovo’s
definitive proxy statement on Schedule 14A relating to the 2019
Annual Meeting of Stockholders, filed with the SEC on July 26,
2019. These documents are available free of charge from the sources
indicated above.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200226005236/en/
Organovo: Taylor J. Crouch 858 779 2494
info@organovo.com
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