Combined company to operate as Tarveda
Therapeutics upon closing of merger
Transaction to advance Tarveda’s proprietary
Pentarin® miniature drug conjugates including its two clinical
programs for the treatment of solid tumor malignancies
Companies to host conference call today at 8:30
AM ET
Organovo Holdings, Inc. (“Organovo”) (Nasdaq: ONVO) and Tarveda
Therapeutics, Inc. (“Tarveda”), a privately-held, clinical stage
biopharmaceutical company developing a new class of potent and
selective precision oncology medicines, which it refers to as
Pentarin miniature drug conjugates, today announced that they have
entered into a definitive merger agreement under which Tarveda
would merge with a wholly-owned subsidiary of Organovo in an
all-stock transaction. Upon completion of the merger, the merged
company would operate under the name Tarveda Therapeutics, Inc. and
trade on the Nasdaq Stock Market LLC under the ticker symbol
“TVDA.”
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the full release here:
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Tarveda is primarily focused on the development of its pipeline
of Pentarin miniature drug conjugates designed to selectively
accumulate and retain anti-cancer payloads in solid tumor
malignancies. Following the closing of the merger, Tarveda intends
to continue to focus on advancing its two clinical stage oncology
programs, PEN-866 and PEN-221, and on further development of novel
conjugates from its proprietary miniature drug conjugate platform.
At the closing of the merger, it is estimated that the combined
company will have approximately $35 million of cash on hand that is
expected to provide sufficient funding into the second half of 2021
to achieve key upcoming clinical data milestones on both clinical
programs.
“After completing an extensive and thorough review of strategic
alternatives, we are extremely pleased to announce this transaction
with Tarveda, which we believe is in the best interest for our
stockholders,” said Taylor J. Crouch, President and Chief Executive
Officer, Organovo. “Tarveda is advancing an innovative pipeline of
clinical stage cancer therapies derived from the company’s
proprietary miniature drug conjugate platform. Tarveda is supported
by a strong syndicate of investors including Novo A/S, Versant
Ventures and ND Capital (NanoDimension) and a highly seasoned
management team with prior public company experience."
“Our growing portfolio of miniature drug conjugates has the
potential to represent much needed new treatment options for
patients with solid tumor malignancies,” said Drew Fromkin,
President and Chief Executive Officer of Tarveda. “We are
encouraged by the activity and tolerability demonstrated in Phase 1
human studies of our two clinical programs, PEN-866 and PEN-221.
Our Pentarin miniature drug conjugates are designed to incorporate
the best properties of small molecule drugs and antibody drug
conjugates to form miniature drug conjugates that are effective at
rapidly and deeply penetrating solid tumors while minimizing damage
to healthy tissue. We are excited about this merger with Organovo
and believe that this is the right point in Tarveda’s trajectory to
move forward as a publicly traded company given several upcoming
clinical data milestones that we expect to be achieved in 2020 and
2021.”
Tarveda expects the merger to provide the capital required to
advance its two lead programs through the next set of clinical
milestones and to generate novel conjugates from its Heat Shock
Protein 90 (HSP90) binding miniature drug conjugate platform.
PEN-866, the initial clinical program from Tarveda’s HSP90 binding
miniature drug conjugate platform, is designed to bind to the
activated form of HSP90 in solid tumors to accumulate and retain
its potent topoisomerase 1 inhibitor (SN-38) payload. PEN-866 is
completing the Phase 1 dose escalation and safety portion of its
“all comers” trial in various types of solid tumors and has shown
to be well tolerated and demonstrated early clinical activity in
heavily treated, advanced patients with a range of solid tumor
malignancies. Beginning in early 2020, it is expected that PEN-866
will be evaluated in a Phase 2a study both as a single agent and as
a combination therapy across a range of solid tumors that are
sensitive to topoisomerase 1 inhibitors. PEN-221 is a miniature
drug conjugate in clinical evaluation for the treatment of patients
with solid tumors expressing somatostatin receptor 2 (SSTR2) on the
cell surface and is linked to the potent tubulin inhibitor payload,
DM1. In a Phase 1 study, PEN-221 was well tolerated and
demonstrated early clinical activity. PEN-221 is currently being
evaluated in a Phase 2a study for the treatment of patients with
neuroendocrine tumors and small cell lung cancer.
About the Proposed Merger
Under the terms of the merger, it is anticipated that Tarveda
stockholders will own approximately 75% of the combined company and
current Organovo stockholders will own approximately 25% of the
combined company on a fully-diluted basis. The exchange ratio is
based on valuation assumptions for both companies subject to
potential adjustments for certain financial metrics prior to the
completion of the merger.
The transaction has been approved by the boards of directors of
both companies. The merger is anticipated to close in the first
quarter of 2020, subject to the approval of Organovo and Tarveda
stockholders as well as other customary closing conditions.
Roth Capital Partners served as financial advisor, and Gunderson
Dettmer Stough Villeneuve Franklin & Hachigian, LLP served as
legal counsel to Organovo. Canaccord Genuity served as financial
advisor, and Cooley LLP served as legal counsel, to Tarveda.
Management and Organization
Following the merger, the combined company will be led by the
current Tarveda management team, including Drew Fromkin as
President, Chief Executive Officer and Chairman; Jeffrey D. Bloss,
M.D., Chief Medical Officer; Brian Roberts, Chief Financial
Officer; Mark Bilodeau, Ph.D., Chief Scientific Officer; and
Sudhakar Kadiyala Ph.D., Executive Vice President, Strategy.
The Board of Directors of the combined company will be comprised
of eight directors, including six directors to be named by Tarveda
and two directors to be named by Organovo. The corporate
headquarters will be located in Watertown, MA.
Conference Call
Organovo and Tarveda will host a conference call at 8:30 a.m. ET
on December 16, 2019, to discuss the proposed transaction. The
conference call may be accessed by dialing (866) 405-4577
(domestic) or (602) 563-8680 (international) and using the
conference ID 3679123. To help ensure the conference call begins in
a timely manner, please dial in five minutes prior to the scheduled
start time. The conference call will also be simultaneously webcast
at http://www.organovo.com.
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.
Important Information and Where to Find It
This communication may be deemed to be solicitation material in
respect of the proposed transaction between Organovo and Tarveda.
In connection with the proposed transaction, Organovo intends to
file relevant materials with the SEC, including a registration
statement on Form S-4 that will contain a proxy
statement/prospectus/information statement. BEFORE MAKING ANY
VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED
TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of
charge, copies of the definitive proxy 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
at Organovo’s website.
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 transaction.
Information regarding the special interests of these directors and
executive officers in the merger will be included in the 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. This document is
available free of charge at the SEC website (www.sec.gov) or at
Organovo’s website.
About Tarveda Therapeutics®, Inc.
Tarveda Therapeutics is a clinical stage biopharmaceutical
company developing a new class of potent and selective precision
oncology medicines, which it refers to as Pentarin® miniature drug
conjugates, for the treatment of patients with various solid tumor
malignancies. Tarveda currently has two Pentarin miniature drug
conjugates in clinical trials. Its first clinical program, PEN-866,
is its initial candidate from its Heat Shock Protein 90 (HSP90)
binding miniature drug conjugate platform. HSP90 is a molecular
chaperone that is highly activated in the harsh tumor environment
across a wide range of solid tumor cancers, but which remains
relatively dormant in normal tissue. PEN-866 is currently
completing its Phase 1 dose escalation portion of its “all comers”
trial of various types of solid tumors and is anticipating
conclusion of this Phase 1 dose escalation study in the first
quarter of 2020. Tarveda’s second clinical program, PEN-221, is a
Pentarin miniature drug conjugate currently in clinical evaluation
for the treatment of patients with solid tumors expressing
somatostatin receptor 2, or SSTR2, on the cell surface such as
neuroendocrine tumors and small cell lung cancer. PEN-221 is a
proprietary asset discovered in-house and is currently progressing
through its Phase 2a trial. For more information regarding Tarveda,
go to: http://www.tarvedatx.com.
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 transaction and other matters. 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, management. 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 transaction are not satisfied,
including the failure to obtain stockholder approval for the
transaction in a timely manner or at all; uncertainties as to the
timing of the consummation of the transaction and the ability of
each of Organovo and Tarveda to consummate the transaction; risks
related to Organovo’s continued listing on the Nasdaq Global Market
or Nasdaq Capital Market until closing of the proposed transaction;
risks related to Organovo’s ability to correctly estimate its
operating expenses, its expenses associated with the transaction
and its 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; competitive
responses to the transaction; unexpected costs, charges or expenses
resulting from the transaction; potential adverse reactions or
changes to business relationships resulting from the announcement
or completion of the transaction; legislative, regulatory,
political and economic developments; the combined company’s
expected cash position at the closing of the proposed merger and
other factors discussed in the risk factors included in Organovo’s
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. Risks and
uncertainties related to Tarveda that may cause actual results to
differ materially from those expressed or implied in any
forward-looking statement include, but are not limited to the
future operations and success of the combined company, including
with respect to the continued development of Tarveda’s product
pipeline; the nature, strategy and focus of the combined company;
the success, cost and timing of the combined company’s product
development activities, studies and clinical trials, the success of
competing products that are or become available, the combined
company’s ability to obtain FDA approval for and commercialize its
product candidates; the executive and board structure of the
combined company; the location of the combined company’s corporate
headquarters; the combined company having sufficient resources to
advance its pipeline; the impact of government laws and
regulations; Tarveda’s ability to protect its intellectual property
position; and the combined company’s estimates regarding future
revenue, expenses, capital requirements and need for additional
financing following the proposed transaction. In addition, the
forward-looking statements included in this press release 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191216005228/en/
Organovo: Taylor Crouch 858 779 2494
info@organovo.com
Tarveda: Amanda Houlihan MacDougall 781 235 3060
ahoulihan@macbiocom.com
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