Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company
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 year ended December 31,
2022, and provided an update on its pipeline and other corporate
developments.
“Our team is very excited about the new
direction of the company. We remain focused on the development of
emricasan as a potential treatment for acute bacterial skin and
skin structure infections (ABSSSI), including those related to
methicillin resistant staphylococcus aureus (“MRSA”) and our
pre-clinical evaluations of our caspase-1 inhibitors that impact
the inflammasome pathway,” said Steven J. Mento, Ph.D., Interim
President and Chief Executive Officer.
Highlights from Year Ended 2022 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 the fourth quarter of 2021, we completed
our pre-clinical evaluation of emricasan for the potential
treatment of acute bacterial skin infections, including those
related to MRSA, and anticipate initiating clinical development
activities for the treatment of ABSSSI in the first half of 2023.
- Amerimmune Collaboration – In November
2022, in accordance with an arbitration award, we terminated the
Amerimmune Collaboration Agreement and all rights to emricasan,
CTS-2090, and CTS-2096 were returned to us.
- Appointed Alfred P. Spada, Ph.D. as Chief Scientific
Officer - In January 2023, Dr. Spada joined Histogen as
its Executive Vice President and Chief Scientific Officer. Dr.
Spada is a seasoned veteran of pharmaceutical discovery and
development with over 35 years of combined experience in large
Pharma and Biotech. He most recently served as President and CEO of
Aya Biosciences. Prior to joining Aya Biosciences, Dr. Spada was
co-founder, EVP of R&D and CSO of Conatus Pharmaceuticals until
its merger with Histogen in May 2020. At Conatus, Dr. Spada was
responsible for the management of all preclinical and early-stage
development activities employed to support the company’s clinical
assets. Prior to Conatus, Dr. Spada was the VP of Preclinical and
Pharmaceutical Development at Idun Pharmaceuticals until its
acquisition by Pfizer in 2005.
- HST 003 and HST 004 – In December 2022, we
announced the termination of our Phase 1/2 clinical study of HST
003 to evaluate the safety and efficacy of human extracellular
matrix (hECM)- to repair cartilage defects in the knee in
combination with a microfracture procedure for futility related to
patient recruitment. In the third quarter of 2022, we announced
suspending all IND enabling activities on our HST 004 program
focused on spinal disc repair due to pipeline
reprioritization.
Full-Year 2022 Financial
Highlights
Twelve Months Ended December 31, 2022 and
2021
Revenues
For the years ended December 31, 2022 and
2021, we recognized license revenues of $3.8 million and $27
thousand, respectively. The increase 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.
For the years ended December 31, 2022 and
2021, we recognized product revenues of $0 and $0.9 million,
respectively. The product revenue for the year ended December 31,
2021 was due to a one-time unanticipated sale of CCM to Allergan,
unrelated to the Allergan Agreements. As of March 31, 2021, all
obligations of the Company related to the additional supply of CCM
to Allergan under the Allergan Agreements had been completed.
For the years ended December 31, 2022 and 2021,
we recognized grant revenue of $0 and $0.1 million, respectively.
The grant revenue for 2021 is associated with a research and
development grant awarded to the Company from the NSF. As of March
31, 2021, all work required by the Company under the grant has been
completed.
Cost of product revenues for
the years ended December 31, 2022 and 2021, we recognized $0
and $0.2 million, respectively, for cost of product sold to
Allergan under the Allergan Agreements.
Research and development
expenses for the years ended December 31, 2022 and
2021 were $5.0 million and $8.5 million, respectively. The decrease
of $3.5 million was primarily due to decreases in personnel related
expenses, the number of clinical and preclinical candidates in
development and corresponding reduction of costs, partially offset
by facility rent increases.
General and administrative
expenses for the years ended December 31, 2022 and
2021 were $9.4 million and $7.8 million, respectively. The increase
of $1.6 million was primarily due to increases in royalty expenses,
legal fees, outside services, rent expenses and personnel expenses,
partially offset by reductions in insurance and other
administrative expenses.
Cash and cash equivalents as of
December 31, 2022 were $12.1 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. Our product candidates include emricasan, CTS-2090
and CTS-2096. 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 CTS-2096, 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 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 and CTS-2096. 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
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except share and per
share amounts)
|
|
Years Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
Product revenue |
|
$ |
— |
|
|
$ |
892 |
|
License revenue |
|
|
3,769 |
|
|
|
27 |
|
Grant revenue |
|
|
— |
|
|
|
113 |
|
Total revenue |
|
|
3,769 |
|
|
|
1,032 |
|
Operating expense |
|
|
|
|
|
|
Cost of product revenue |
|
|
— |
|
|
|
220 |
|
Research and development |
|
|
5,021 |
|
|
|
8,473 |
|
General and administrative |
|
|
9,391 |
|
|
|
7,796 |
|
Total operating expense |
|
|
14,412 |
|
|
|
16,489 |
|
Loss from
operations |
|
|
(10,643 |
) |
|
|
(15,457 |
) |
Other income
(expense) |
|
|
|
|
|
|
Interest expense, net |
|
|
(1 |
) |
|
|
(10 |
) |
Other income, net |
|
|
— |
|
|
|
458 |
|
Net
loss |
|
|
(10,644 |
) |
|
|
(15,009 |
) |
Loss attributable to noncontrolling interest |
|
|
23 |
|
|
|
59 |
|
Deemed dividend - accretion of discount and redemption feature of
redeemable convertible preferred stock |
|
|
(488 |
) |
|
|
— |
|
Net loss
available to common stockholders |
|
$ |
(11,109 |
) |
|
$ |
(14,950 |
) |
Net loss per
share available to common stockholders, basic and diluted |
|
$ |
(3.46 |
) |
|
$ |
(7.79 |
) |
Weighted-average number of common shares outstanding used to
compute net loss per share, basic and diluted |
|
|
3,211,139 |
|
|
|
1,918,176 |
|
HISTOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands, except share and per share amounts)
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,109 |
|
|
$ |
18,685 |
|
Restricted cash |
|
|
400 |
|
|
|
400 |
|
Accounts receivable, net |
|
|
99 |
|
|
|
165 |
|
Prepaid and other current assets |
|
|
848 |
|
|
|
2,359 |
|
Total current assets |
|
|
13,456 |
|
|
|
21,609 |
|
Property and
equipment, net |
|
|
436 |
|
|
|
399 |
|
Right-of-use
asset |
|
|
4,658 |
|
|
|
4,432 |
|
Other
assets |
|
|
523 |
|
|
|
805 |
|
Total assets |
|
$ |
19,073 |
|
|
$ |
27,245 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
382 |
|
|
$ |
1,393 |
|
Accrued liabilities |
|
|
595 |
|
|
|
791 |
|
Current portion of lease liabilities |
|
|
238 |
|
|
|
127 |
|
Current portion of deferred revenue |
|
|
19 |
|
|
|
19 |
|
Total current liabilities |
|
|
1,234 |
|
|
|
2,330 |
|
Lease
liabilities, non-current |
|
|
4,379 |
|
|
|
4,617 |
|
Deferred
revenue, non-current |
|
|
79 |
|
|
|
98 |
|
Finance
lease liability, non-current |
|
|
5 |
|
|
|
14 |
|
Total liabilities |
|
|
5,697 |
|
|
|
7,059 |
|
Commitments
and contingencies (Note 9) |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred
stock, $0.0001 par value; 10,000,000 shares authorized at December
31, 2022 and 2021; no shares issued and outstanding at December 31,
2022 and 2021 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 200,000,000 shares authorized at December
31, 2022 and 2021; 4,271,759 and 2,497,450 shares issued and
outstanding at December 31, 2022 and 2021, respectively |
|
|
5 |
|
|
|
5 |
|
Additional
paid-in capital |
|
|
102,673 |
|
|
|
98,839 |
|
Accumulated
deficit |
|
|
(88,273 |
) |
|
|
(77,652 |
) |
Total Histogen Inc. stockholders’ equity |
|
|
14,405 |
|
|
|
21,192 |
|
Noncontrolling interest |
|
|
(1,029 |
) |
|
|
(1,006 |
) |
Total equity |
|
|
13,376 |
|
|
|
20,186 |
|
Total
liabilities and stockholders’ equity |
|
$ |
19,073 |
|
|
$ |
27,245 |
|
CONTACT:
Susan A. KnudsonExecutive Vice President &
CFO Histogen Inc. ir@histogen.com
Grafico Azioni Histogen (NASDAQ:HSTO)
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