Histogen Reports First Quarter 2023 Results and Provides Business Update
11 Mayo 2023 - 3:05PM
Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company
focused on developing potential first-in-class clinical and
preclinical small molecule pan-caspase and caspase selective
inhibitors that protect the body’s natural process to restore
immune function, today reported financial results for the first
quarter ended March 31, 2023, and provided an update on its
pipeline and other corporate developments.
“The team has done a fantastic job of executing
on critical milestones that support the development of emricasan as
a potential treatment for ABSSSI,” said Steven J. Mento, Ph.D.,
President and Chief Executive Officer. “We believe that emricasan
has the potential to treat infections in a different way; by
protecting the competence of the human body’s immune system thereby
restoring the body’s natural process to combat invading organisms,”
stated Dr. Mento. “The previously reported positive results in the
COVID clinical trial together with the compelling preclinical data
in bacterial skin disease point to a potential broad opportunity
for emricasan as a more generalized host-based immunotherapeutic
treatment of both viral and bacterial infections without the risk
of generating resistance.”
Highlights from the First Quarter and
Business Updates
- Emricasan ABSSSI –
Emricasan is an orally available pan-caspase inhibitor designed to
reduce the activities of human caspases, which are enzymes that
mediate inflammation and apoptosis. Emricasan has completed
extensive toxicology testing including chronic toxicology and clean
carcinogenicity testing. This drug candidate has previously been
shown to be well tolerated in multiple clinical studies involving
approximately 1,000 subjects employing multiple doses ranging from
1 mg to 500 mg orally with treatment for up to two years, including
a Phase 1 study in mild symptomatic COVID-19 patients to assess
safety, tolerability, and preliminary efficacy.In April 2023, we
announced the online publication of an abstract describing our
preclinical study in mice showing that emricasan has therapeutic
effect against bacterial skin infections. In the study, the role of
the irreversible pan-caspase inhibitor emricasan alone and in
combination with a standard-of-care antibiotic, doxycycline, was
examined as a potential host-directed immunotherapy against
bacterial infections in a mouse model commonly used to test the
effectiveness of the innate immune response. Mice in four groups;
placebo, placebo plus doxycycline, emricasan plus doxycycline, and
emricasan alone were treated orally twice daily for 7 days after
intradermal injection of the established CA-MRSA strain USA300 of
Staphylococcus aureus in mice. The results of the study show that:
(1) emricasan alone reduced both lesion size and bacterial burden
versus placebo (p<0.0001); (2) emricasan alone showed efficacy
superior to doxycycline alone in lesion size (p=0.02); and (3)
emricasan alone and emricasan plus doxycycline showed comparable
efficacy versus placebo in both lesion size and bacterial burden
(p<0.0001).Additionally, in March 2023, we received notice from
the FDA related to our recently filed IND for emricasan for the
treatment of ABSSSI that the “Study May Proceed.” Assuming we raise
sufficient capital, we anticipate initiation of clinical
development in the second half of 2023.
- Exclusive Intellectual
Property License Agreement with Johns Hopkins – In April
2023, we signed an exclusive license agreement with Johns Hopkins
University. The intellectual property associated with this license
covers the use of emricasan for the treatment of disease in humans
resulting from viral or bacterial infections (including, but not
limited to, MRSA, VRSA, and SARS-CoV-2). The license agreement with
Johns Hopkins is an instrumental addition to Histogen’s
intellectual property portfolio. Rights to these patent
applications, together with recently issued internal patents, are
expected to provide freedom to operate and exclusivity worldwide to
the Histogen’s entire caspase inhibitor portfolio.
- Steven J. Mento Ph.D.
appointed President and CEO – In March 2023, Dr. Mento was
appointed President and CEO. Dr. Mento served as Histogen’s
Executive Chairman and Interim President and CEO from November of
2021 to March 2023 and as a member of our Board since July 2005.
Dr. Mento was one of Conatus’ co-founders and served as Conatus’
President and Chief Executive Officer from July 2005 until the
merger with Histogen. From July 2005 until December 2012, Dr. Mento
also served as Chairman of Conatus’ Board of Directors. Dr. Mento
has over 40 years of combined experience in the biotechnology and
pharmaceutical industries serving in a broad range of senior
executive and scientific positions. He previously served as
President, Chief Executive Officer, and a member of the Board of
Directors of Idun Pharmaceuticals prior to its sale in 2005 to
Pfizer.
First Quarter 2023 Financial
Highlights: Three Months Ended March 31, 2023 and
2022
Revenues for the three months
ended March 31, 2023 and 2022, we recognized license revenue
of $5 thousand and $3.8 million, respectively. The decrease in the
current period is due to a one-time payment of $3.75 million
received in March 2022 as consideration for execution of the
Allergan Letter Agreement.
Research and development
expenses for the three months ended March 31, 2023
and 2022 were $1.0 million and $1.9 million, respectively. The
decrease of $0.9 million was primarily due to decreases in
outsourced manufacturing facility expenses, personnel related
expenses, and the number of clinical and preclinical candidates in
development and corresponding reduction of costs.
General and administrative
expenses for both the three months ended March 31,
2023 and 2022 were $2.5 million. While there was no difference in
expense between the periods, the change in the type of expenses for
the period ended March 31, 2023 as compared to March 31, 2022 was
primarily increases in stock-based compensation, outside services,
and rent expenses, offset by reductions in royalty expenses, legal,
insurance, and personnel related expenses.
Cash and cash equivalents as of
March 31, 2023 were $9.7 million. Histogen believes that its
existing cash and cash equivalents and cash inflow from operations
will be sufficient to meet Histogen’s anticipated cash needs into
January of 2024.
About Histogen Inc.
Histogen Inc. is a clinical-stage therapeutics
company focused on developing potential first-in-class clinical and
preclinical small molecule pan-caspase and caspase selective
inhibitors that protect the body’s natural process to restore
immune function. Currently, we are developing emricasan for acute
bacterial skin and skin structure infections (ABSSSI) as well
evaluating its use for other infectious diseases. Our pipeline also
includes novel preclinical product candidates including CTS-2090
and other proprietary caspase inhibitors, which are selective small
molecule inhibitors of caspase-1 designed for the treatment of
certain inflammatory diseases. 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 the potential benefits of the license
with Johns Hopkins University and our expectation that the license
will provide freedom to operate and exclusivity; the potential
benefits of the preclinical study in mice showing that emricasan
has therapeutic effect against bacterial skin infections; our
future operations and our ability to successfully initiate, enroll
and complete clinical trials, obtain clinical trial data, and
achieve regulatory milestones and related timing, including those
related to the timing of providing clinical development guidance on
the development of emricasan and any further evaluation of
CTS-2090. We 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 our 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: our ability to obtain funding for
our operations, including funding necessary to complete further
development and any commercialization of our product candidates;
including its ability to carry out the development of emricasan and
the potential for delays in the timing of regulatory approval and
the requirement for additional capital to continue to advance these
product candidates, which may not be available on favorable terms
or at all; our expectations regarding the operation of our product
candidates and related benefits; our beliefs regarding the success,
cost and timing of our product candidate development and current
and future clinical trials and studies; our beliefs regarding
the potential markets for our product candidates; any
impact of the COVID-19 pandemic, or responses to the pandemic, on
our business, clinical trials or personnel; our beliefs
regarding our industry; our ability to attract and
retain key personnel; regulatory developments in the United States
and foreign countries, with respect to our product candidates; the
impact of any litigation proceedings on our business and market and
other conditions. 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 our 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.
|
|
HISTOGEN INC. AND SUBSIDIARIES UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except share and per
share amounts) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
License revenue |
|
$ |
5 |
|
|
$ |
3,755 |
|
Total revenue |
|
|
5 |
|
|
|
3,755 |
|
Operating expense |
|
|
|
|
|
|
Research and development |
|
|
993 |
|
|
|
1,932 |
|
General and administrative |
|
|
2,486 |
|
|
|
2,506 |
|
Total operating expense |
|
|
3,479 |
|
|
|
4,438 |
|
Loss from operations |
|
|
(3,474 |
) |
|
|
(683 |
) |
Other income (expense) |
|
|
|
|
|
|
Interest expense, net |
|
|
— |
|
|
|
(1 |
) |
Gain on sale of subsidiary |
|
|
1 |
|
|
|
— |
|
Net loss |
|
|
(3,473 |
) |
|
|
(684 |
) |
Loss attributable to noncontrolling interest |
|
|
3 |
|
|
|
11 |
|
Net loss available to common stockholders |
|
$ |
(3,470 |
) |
|
$ |
(673 |
) |
Net loss per share available to common stockholders, basic and
diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.27 |
) |
Weighted-average number of common shares outstanding used to
compute net loss per share, basic and diluted |
|
|
4,271,759 |
|
|
|
2,497,450 |
|
|
|
HISTOGEN INC. AND SUBSIDIARIES UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands, except share and per share amounts) |
|
|
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,658 |
|
|
$ |
12,109 |
|
Restricted cash |
|
|
300 |
|
|
|
400 |
|
Accounts receivable, net |
|
|
23 |
|
|
|
99 |
|
Prepaid and other current assets |
|
|
627 |
|
|
|
848 |
|
Total current assets |
|
|
10,608 |
|
|
|
13,456 |
|
Property and equipment, net |
|
|
398 |
|
|
|
436 |
|
Right-of-use asset |
|
|
4,576 |
|
|
|
4,658 |
|
Other assets |
|
|
469 |
|
|
|
523 |
|
Total assets |
|
$ |
16,051 |
|
|
$ |
19,073 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
441 |
|
|
$ |
382 |
|
Accrued liabilities |
|
|
629 |
|
|
|
595 |
|
Current portion of lease liabilities |
|
|
251 |
|
|
|
238 |
|
Current portion of deferred revenue |
|
|
19 |
|
|
|
19 |
|
Total current liabilities |
|
|
1,340 |
|
|
|
1,234 |
|
Lease liabilities, non-current |
|
|
4,312 |
|
|
|
4,379 |
|
Deferred revenue, non-current |
|
|
74 |
|
|
|
79 |
|
Finance lease liability, non-current |
|
|
3 |
|
|
|
5 |
|
Total liabilities |
|
|
5,729 |
|
|
|
5,697 |
|
Commitments and contingencies (Note 8) |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at
March 31, 2023 and December 31, 2022; no shares issued and
outstanding at March 31, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 200,000,000 shares authorized at
March 31, 2023 and December 31, 2022; 4,271,759 shares issued and
outstanding at March 31, 2023 and December 31, 2022 |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
103,092 |
|
|
|
102,673 |
|
Accumulated deficit |
|
|
(91,743 |
) |
|
|
(88,273 |
) |
Total Histogen Inc. stockholders’ equity |
|
|
11,354 |
|
|
|
14,405 |
|
Noncontrolling interest |
|
|
(1,032 |
) |
|
|
(1,029 |
) |
Total equity |
|
|
10,322 |
|
|
|
13,376 |
|
Total liabilities and stockholders’ equity |
|
$ |
16,051 |
|
|
$ |
19,073 |
|
CONTACT:
Susan A. KnudsonExecutive Vice President, COO &
CFOHistogen Inc.ir@histogen.com
Histogen (NASDAQ:HSTO)
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