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HSTO - Histogen Inc News Story

$0.793 -0.0  -2.1%

Last Trade - 24/09/21

Sector
Healthcare
Size
Micro Cap
Market Cap £24.2m
Enterprise Value £6.56m
Revenue £1.03m
Position in Universe 6262nd / 7172

Histogen Provides Update on its Development Programs and Pipeline Focus

Thu 3rd June, 2021 1:00pm
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Company to Focus its Regenerative Medicine Technology Platform on Developing
Orthopedic Product Candidates

HST 003 Trial for Cartilage Regeneration in the Knee Remains On-Track with an
Anticipated Phase 1/2 Study Initiation in June 2021

HST 004 Selected as Product Candidate for Spinal Disc Repair with IND Enabling
Activities Underway

Top-line Data for Phase 1 Study of Emricasan in Mild-Symptomatic COVID-19
Patients Anticipated in June 2021

SAN DIEGO, June 03, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a
clinical-stage therapeutics company focused on developing potential
first-in-class restorative therapeutics that ignite the body’s natural
process to repair and maintain healthy biological function, today announced an
update on its pipeline focus following a strategic evaluation of its
regenerative medicine platform technology development programs with the goal
of focusing on high value orthopedic indications, creating pipeline synergies
and maximizing resources in an effort to further drive long-term shareholder
value.

Development Program Updates
* HST 001 – we completed our strategic evaluation of the HST 001 program
taking into consideration the results from our Phase 1b/2a clinical trial of
HST 001 as announced earlier this year, and as a result, we will suspend
development of this program. While HST 001 has demonstrated a favorable safety
and tolerability profile in androgenic alopecia in men, the development
resources required to potentially achieve an acceptable efficacy threshold are
substantial in terms of cost and time. Therefore, we believe the best business
decision at this time, is to redirect these resources towards our high value
orthopedic programs.

* HST 003 - we are on track to initiate our Phase 1/2 clinical study of HST
003 in June 2021. The upcoming study is designed to evaluate the safety and
efficacy of human extracellular matrix (hECM) implanted within microfracture
interstices and the cartilage defect in the knee to regenerate hyaline
cartilage in combination with a microfracture procedure. Patients will be
enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in
Vail, CO, and Walter Reed Medical Center in Bethesda, MD.
* HST 004 - We recently initiated an investigational new drug application
(IND) enabling activities for HST 004, a CCM solution intended to be
administered through an intradiscal injection for spinal disc repair.  Our
initial preclinical research has shown that HST 004 stimulates stem cells from
the spinal disc to proliferate and secrete aggrecan and collagen II,
regenerate normal matrix and cell tissue structure, and restore disc height.
HST 004 was also shown to both reduce inflammation and protease activity and
upregulate aggrecan production in an ex vivo spinal disc model. We anticipate
filing an IND in the second half of 2022.


* Emricasan – In May, we, along with our partner Amerimmune, completed
enrollment of the Phase 1 study of emricasan for the treatment of
mild-symptomatic COVID-19 patients. A total of 13 patients have been enrolled
at our single site in New York City versus the initially targeted 40 patients.
The decision to stop enrollment with a lesser number of patients was based
solely upon the overall decline in COVID-19 cases in New York City and its
negative impact on patient recruitment. To date, there have been no reports of
serious adverse events, and we anticipate top-line safety, biomarker and
patient reported outcomes data to be available in June 2021.
“Following the completion of our HST 001 Phase 1a/2b study in androgenic
alopecia in men in the first quarter of this year, we embarked upon a
strategic pipeline evaluation with the goal of determining the optimal
value-creating opportunities for our regenerative medicine technology
platform,” said Richard W. Pascoe, President and Chief Executive Officer.
“As a result of our evaluation, we have charted a new course for Histogen
with a focus on orthopedic indications that we believe sit at the crossroads
of pre-clinical and clinical proof of concept, significant commercial
opportunity, and unmet medical needs. Moreover, we believe that by developing
products that are therapeutically synergistic, we can be more efficient with
our resources and create a strategic pipeline of novel therapeutics that has
the potential to create long-term value for the benefit of our
shareholders.”

About Histogen Inc.

Histogen Inc. is a clinical-stage therapeutics company focused on developing
potential first-in-class restorative therapeutics that ignite the body’s
natural process to repair and maintain healthy biological function.
Histogen’s innovative technology platform utilizes cell conditioned media
and extracellular matrix materials produced by hypoxia-induced multipotent
cells. Histogen’s proprietary, reproducible manufacturing process provides
targeted solutions across a broad range of therapeutic indications including
joint cartilage regeneration, spinal disk repair, hair growth and dermal
rejuvenation. For more information, please visit www.histogen.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the “safe harbor” provisions of the Private Securities Litigation Reform
Act of 1995 and other Federal securities laws. For example, we are using
forward-looking statements when we discuss Histogen’s future operations and
its ability to successfully initiate and complete clinical trials, obtain
clinical trial data and achieve regulatory milestones and related timing,
including those related to the suspension of the HST 001 program, the
commencement of the planned HST 003 Phase 1/2 clinical trial for regeneration
of cartilage in the knee, the anticipated filing of the HST 004 IND for spinal
disc repair and the completion and reporting of topline data for the Phase 1
study of emricasan for the treatment of COVID-19; the nature, strategy and
focus of Histogen’s business; the sufficiency of Histogen’s cash resources
and its ability to achieve value for its stockholders, specifically given the
strategic shift to orthopedic indications; the sufficiency of Amerimmune’s
cash resources and its ability to complete the Phase 1 study of emricasan and
achieve value for Histogen’s stockholders; and the development and
commercial potential and potential benefits of any of Histogen’s product
candidates, such as HST 003, HST 004 and the Collaborative Development and
Commercialization Agreement with Amerimmune and any other collaboration
agreements. Histogen may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in the
forward-looking statements and you should not place undue reliance on these
forward-looking statements. Because such statements deal with future events
and are based on Histogen’s current expectations, they are subject to
various risks and uncertainties and actual results, performance or
achievements of Histogen that could differ materially from those described in
or implied by the statements in this press release, including: the
uncertainties associated with the clinical development and regulatory approval
of Histogen’s product candidates, including potential delays in the
commencement, enrollment and completion of clinical trials, such as the
planned HST 003 Phase 1/2 clinical trial for regeneration of cartilage in the
knee, the anticipated filing of the HST 004 IND for spinal disc repair and
Amerimmune’s ability to further develop emricasan for the treatment of
COVID-19, including the complexity and length of studies required to
commercialize emricasan for COVID-19 and potential delays in the completion of
clinical trials, such as the emricasan Phase 1 study for the treatment of
COVID-19; Histogen’s dependence on its collaboration partner, Amerimmune, to
carry out the development of emricasan and the potential for delays in the
timing of regulatory approval; competition in the orthopedics market, COVID-19
market and other markets in which Histogen and its collaboration partner
operate; the potential that earlier clinical trials and studies of
Histogen’s product candidates may not be predictive of future results; risks
related to business interruptions, including the outbreak of COVID-19
coronavirus, which could seriously harm Histogen’s financial condition and
increase its costs and expenses; and the requirement for additional capital to
continue to advance these product candidates, which may not be available on
favorable terms or at all. The foregoing review of important factors that
could cause actual events to differ from expectations should not be construed
as exhaustive and should be read in conjunction with statements that are
included herein and elsewhere, including those risks discussed in Histogen’s
filings with the Securities and Exchange Commission. Except as otherwise
required by law, Histogen disclaims any intention or obligation to update or
revise any forward-looking statements, which speak only as of the date hereof,
whether as a result of new information, future events, or circumstances or
otherwise.

CONTACT:

Susan A. Knudson
Executive Vice President & CFO 
Histogen Inc. 
ir@histogen.com



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