Histogen Inc., a regenerative medicine company with a novel
biological platform that replaces and regenerates tissues in the
body, announced today that the U.S. Food and Drug Administration
(FDA) has approved its Investigational New Drug (IND) application
for HST 001, the Company’s lead therapeutic candidate for the
treatment of androgenic alopecia in men.
Under this IND, Histogen intends to initiate a
Phase 1b/2a clinical trial of HST 001, a Hair Stimulating Complex
(HSC), in the second quarter of 2020. This clinical trial is
designed to assess the safety, tolerability and efficacy of HST
001, as well as determine optimal dosing in male pattern hair loss.
Start-up activities are currently underway to include clinical
study site preparation and subject screening.
“The FDA acceptance of our IND application
represents an important milestone for Histogen and HST 001 and
keeps us on schedule to commence our clinical trial in androgenic
alopecia as planned in June 2020,” said Richard Pascoe, Chief
Executive Officer of Histogen. “Moreover, with the anticipated
completion of the merger with Conatus Pharmaceuticals, and
subsequent listing on the Nasdaq in the second quarter of this
year, we are focused on creating shareholder value in 2020 and
beyond through the advancement of our novel clinical pipeline.”
Histogen’s product candidates are derived from a
single, proprietary manufacturing process that yields materials
that replace tissues in the body or stimulate the body’s own cells
to regenerate. In addition to clinical development of HST 001,
Histogen anticipates IDE approval to initiate a Phase 1 clinical
trial of a novel dermal filler (HST 002) in the coming months, and
IND submission of its joint cartilage regeneration product
candidate (HST 003) later this year.
About HST 001HST 001, or
Hair Stimulating Complex (HSC), is intended to be a
physician-administered therapeutic for hair loss. HSC is
anticipated to be a safe, minimally-invasive treatment that
promotes new hair growth where existing treatments only reduce hair
loss. HSC is manufactured to enrich for growth factors including
KGF, VEGF, and follistatin, which are involved in signaling stem
cells in the body, and have been shown to be important in hair
formation and the stimulation of resting hair follicles.
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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