Histogen Inc., a regenerative medicine company with a novel
biological platform that replaces and regenerates tissues in the
body, announced today that it has submitted an Investigational
Device Exemption (IDE) application with the U.S. Food and Drug
Administration (FDA) for the initiation of a Phase 1 clinical trial
of HST 002 for the treatment of facial folds and wrinkles.
HST 002 is a naturally produced collagen and extracellular
matrix dermal filler targeting the treatment of facial folds and
wrinkles. The planned Phase 1 clinical trial is designed to assess
the safety and tolerability of HST 002, as well as look for early
indications of efficacy versus a placebo control.
“The submission of this Investigational Device Exemption for HST
002 is an important milestone for Histogen as we continue to
advance our development pipeline following the recent submission of
our Investigational New Drug Application Amendment for HST 001 for
hair loss,” said Richard W. Pascoe, Histogen’s Chairman and Chief
Executive Officer. “We look forward to moving both of these assets
into the clinic following FDA acceptance of these applications.
Moreover, we look forward to completing our previously announced
merger with Conatus Pharmaceuticals which is on track to close in
the second quarter of this year.”
If successful, HST 002 would be novel in the dermal filler
market as it is comprised of all-human and naturally produced
collagen with dermal matrix proteins with the potential to reduce
the risk of inflammation. In addition to clinical development of
HST 002, Histogen recently announced the filing of an IND amendment
for its lead product for hair loss (HST 001) and the anticipated
IND filing for its joint cartilage regeneration (HST 003) product
candidate in 2020.
Histogen’s Planned Merger with Conatus
PharmaceuticalsOn January 28, 2020, Histogen announced
that it entered into a definitive agreement with Conatus
Pharmaceuticals Inc. (Nasdaq: CNAT) pursuant to which Histogen will
merge with and into a wholly-owned subsidiary of Conatus in an
all-stock transaction. The combined company is expected to operate
under the name “Histogen Inc.”, and after closing, the combined
company is expected to change its trading symbol to “HSTO” and
trade on the Nasdaq Capital Market, and to focus on advancement of
its patented technology for dermatological and orthopedic
indications.
Under the terms of the merger agreement, pending stockholder
approval of the transaction, Histogen will merge with a
wholly-owned subsidiary of Conatus and Histogen stockholders will
receive newly issued shares of Conatus common stock. The exchange
ratio used to determine the number of shares of Conatus common
stock issuable to Histogen stockholders pursuant to the merger will
be determined using a pre-transaction valuation of $100 million for
Histogen’s business, based on its latest priced investment round
and clinical pipeline advancement, and $35.135 million for Conatus’
business, an approximately 155% premium to the 20-day volume
weighted average closing share price of Conatus common stock prior
to the announcement date on the Nasdaq Capital Market. As a result,
current Conatus stockholders will collectively own approximately
26%, and Histogen stockholders will collectively own approximately
74%, of the combined company on a fully-diluted basis, after taking
into account Histogen’s and Conatus’ outstanding options and
warrants at the time of closing, irrespective of the exercise
prices of such options and warrants, with such ratio subject to
adjustment based on each company’s net cash balance at closing.
The combined company, led by Histogen’s current management team,
will be named Histogen Inc. and be headquartered in San Diego, CA.
After closing, the combined company is expected to change its
trading symbol to “HSTO” and trade on the Nasdaq Capital Market. At
closing, the combined company’s board of directors is anticipated
to consist of eight members, including six members of Histogen’s
current board and two members of Conatus’ current board. The merger
agreement has been unanimously approved by the board of directors
of each company, who have also recommended to their respective
company’s stockholders that they approve the merger agreement, the
merger and, with respect to Conatus’ stockholders, a reverse stock
split. The merger is expected to close by the end of the second
quarter of 2020, subject to approvals by the stockholders of
Histogen and Conatus, a reverse stock split being implemented by
Conatus, the continued listing of the combined company on Nasdaq
and other customary closing conditions.
A more complete description of the terms of and conditions of
the merger can be found in Conatus’ Form 8-K filed on January 28,
2020 with the SEC and in the Merger Agreement, which is filed as an
exhibit to that Form 8-K.
About HistogenHistogen is a regenerative
medicine company developing patented technologies that replace and
regenerates tissues in the body. The company’s innovative
technology platform utilizes cell conditioned media and
extracellular matrix materials produced by hypoxia-induced
multipotent cells, developing therapeutic products that address
underserved, multi-billion US dollar global markets. For more
information, please visit www.histogen.com.
About Conatus PharmaceuticalsConatus is a
biotechnology company that had been focused on the development of
novel medicines to treat chronic diseases with significant unmet
need. For additional information, please visit
www.conatuspharma.com.
Forward-Looking StatementsCertain statements
herein constitute forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, and are
intended to be covered by the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such statements may be
identified by words such as “believes,” “will,” “would,” “expects,”
“project,” “may,” “could,” “developments,” “launching,”
“opportunities,” “anticipates,” “estimates,” “intends,” “plans,”
“targets” and similar expressions. These forward-looking statements
include, but are not limited to, statements concerning: the
expected structure, timing and completion of the proposed merger;
future product development plans and projected timelines for the
initiation and completion of preclinical and clinical trials; the
potential for the results of ongoing preclinical or clinical trials
and the efficacy of Histogen’s drug candidates; the potential
market opportunities and value of drug candidates; risks related to
business interruptions, including the outbreak of COVID-19
coronavirus, which could seriously harm our financial condition and
increase our costs and expenses; other statements regarding future
product development and regulatory strategies, including with
respect to specific indications; any statements regarding the
combined company’s future financial performance, results of
operations or sufficiency of capital resources to fund operating
requirements; any statements relating to future Nasdaq listing; the
executive and board structure of the combined company; and any
other statements that are not statements of historical fact. These
statements are based upon the current beliefs and expectations of
each company’s management and are subject to significant risks and
uncertainties.
Actual results may differ materially from those set forth in the
forward-looking statements as a result of numerous factors. The
following factors, among others, could cause actual results to
differ materially from the anticipated results expressed in the
forward-looking statements: the risk that the conditions to the
closing of the proposed merger are not satisfied, including the
failure to timely obtain stockholder approval for the transaction,
if at all; uncertainties as to the timing of the consummation of
the proposed merger; risks related to each company’s ability to
manage its operating expenses and its expenses associated with the
proposed merger pending closing; the risk that as a result of
adjustments to the exchange ratio, Conatus stockholders and
Histogen stockholders could own more or less of the combined
company than is currently anticipated; risks related to the market
price of Conatus’ common stock relative to the exchange ratio; the
businesses of Histogen and Conatus may not be combined
successfully, or such combination may take longer than expected;
the combined company’s need for, and the availability of,
substantial capital in the future to fund its operations and
research and development activities; the combined company’s ability
to continue to successfully progress research and development
efforts and to create effective, commercially-viable products; and
the success of the combined company’s product candidates in
completing pre-clinical or clinical testing and being granted
regulatory approval to be sold and marketed in the United States or
elsewhere. Additional factors that could cause actual results to
differ materially from those expressed in the forward-looking
statements are discussed in Conatus’ reports (such as the Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K) filed with the Securities and Exchange
Commission (the “SEC”) and available at the SEC’s Internet website
(www.sec.gov). All subsequent written and oral forward-looking
statements concerning the proposed transaction or other matters
attributable to Histogen or Conatus or any person acting on their
behalf are expressly qualified in their entirety by the cautionary
statements above. Except as required by law, neither Conatus nor
Histogen undertakes any obligation to update any forward-looking
statement to reflect circumstances or events that occur after the
date the forward-looking statement is made.
Additional Information and Where to Find ItThis
communication is not intended to and does not constitute an offer
to sell or the solicitation of an offer to buy any securities or a
solicitation of any vote or approval. This communication may be
deemed to be solicitation material in respect of the proposed
merger. Conatus has filed a registration statement on Form S-4
(File No. 333-236332) containing a definitive proxy statement/
prospectus/information statement of Conatus and Histogen and other
documents concerning the proposed merger with the SEC (which
registration statement was declared effective by the SEC on April
1, 2020). BEFORE MAKING ANY VOTING DECISION, CONATUS’ AND
HISTOGEN’S RESPECTIVE STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE
PROXY STATEMENT/PROSPECTUS/INFORMATION STATEMENT, AND OTHER
RELEVANT DOCUMENTS FILED WITH THE SEC RELATING TO THE PROPOSED
MERGER, INCLUDING DOCUMENTS INCORPORATED INTO THE REGISTRATION
STATEMENT BY REFERENCE, AS THEY CONTAIN IMPORTANT INFORMATION ABOUT
THE PROPOSED MERGER.
In addition to receiving the proxy statement by mail,
stockholders also will be able to obtain these documents, as well
as other filings containing information about Conatus, the proposed
Merger and related matters, without charge, from the SEC’s website
at www.sec.gov. In addition, these documents can be obtained,
without charge, by sending an e-mail to info@conatuspharma.com,
along with complete contact details and a mailing address or by
contacting Conatus at (858) 376-2600.
Participants in the SolicitationThis
communication may be deemed to be solicitation material in respect
of the proposed Merger. Conatus and Histogen, and certain of their
respective directors, executive officers and other members of
management and employees, may, under SEC rules, be deemed to be
participants in the solicitation of proxies from Conatus
stockholders with respect to the proposed merger. Information
regarding the interests of the directors and executive officers of
Conatus and Histogen is set forth in Conatus’ registration
statement on Form S-4 referenced above, containing a definitive
proxy statement/ prospectus/information statement of Conatus and
Histogen and other documents concerning the proposed merger.
Changes to the holdings of Conatus securities by Conatus’ directors
and executive officers have been or will be reflected on Statements
of Change in Ownership on Form 4 filed with the SEC. These
documents (when available) may be obtained free of charge from the
SEC’s website at www.sec.gov.
Non-SolicitationThis communication is not
intended to, and does not, constitute a solicitation of proxy or an
offer to sell or purchase, or a solicitation of an offer to sell or
purchase, any securities; nor shall there be any offer or 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. No public offer of
securities in connection with the proposed Merger shall be made
except by means of a prospectus meeting the requirements of Section
10 of the Securities Act of 1933, as amended.
CONTACT: Keith MarshallConatus Pharmaceuticals
Inc.(858) 376-2600IR@conatuspharma.com
CONTACT: Eileen BrandtHistogen
Inc. (858) 526-3106ebrandt@histogen.com
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