Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company
focused on developing both restorative therapeutics and pan-caspase
and caspase selective inhibitors focused on treatments for
infectious and inflammatory diseases, today reported financial
results for the first quarter ended March 31, 2022 and provided an
update on its clinical pipeline and other corporate developments.
“We continue to focus on clinical execution of
HST-003 in knee cartilage repair, IND enabling activities for
HST-004 in spinal disk regeneration, exploration of testing
emricasan in animal studies for methicillin resistant
staphylococcus aureus infections (“MRSA”), and evaluating our
caspase-1 inhibitors that impact the inflammasome pathway,” said
Steven J. Mento, Ph.D., Interim President and Chief Executive
Officer.
Highlights from the First Quarter 2022 and
Business Updates
- HST-003 – Our
Phase 1/2 clinical study of HST-003 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 is on-going. In the first quarter of 2022, we added three
additional clinical sites to help supplement enrollment of patients
due to the recruitment challenges we have experienced related to
both the specific nature of the study inclusion criteria and the
impact of COVID-19 on the elective surgery environment. We continue
to anticipate top line results in the first half of 2023, assuming
we complete enrollment in the fourth quarter of 2022.
- HST-004 – 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
restores disc height. HST-004 was also shown to reduce inflammation
and protease activity and upregulate aggrecan production in an ex
vivo spinal disc model. We have initiated IND enabling activities
for HST-004 and anticipate filing IND for HST-004 in the second
half of 2023.
- Emricasan COVID-19
Amerimmune Collaboration Agreement - On March 3, 2022, we
filed our demand for arbitration as we believe that Amerimmune has
failed to undertake commercially reasonable efforts toward
conducting and completing the Phase 2 study as required by the
Collaborative Development and Commercialization Agreement that we
previously entered into with Amerimmune in October of 2020.
- Emricasan MRSA -
We continue to make progress on exploring the feasibility of
testing emricasan in animal studies for MRSA. We expect to complete
our feasibility assessment in the second half of 2022 and, subject
to the outcome of the arbitration with Amerimmune, explore further
development of emricasan for MRSA.
- $3.75 Million Allergan
Payment – In March 2022, we received a one-time $3.75
million payment from Allergan pursuant to execution of a letter
agreement entered into on March 18, 2022. The payment represents a
full and final satisfaction of all monies due to the Company
pursuant to the Allergan License Agreement.
First Quarter Ended March 31, 2022
Financial Highlights
Product, License, and Grant
Revenues
For the three months ended March 31, 2022
and 2021, we recognized product revenues of $0 and $0.3 million,
respectively. The revenue for the first quarter of 2021 was related
to the additional supply of CCM to Allergan. As of March 31, 2021,
all obligations of the Company related to the additional supply of
CCM to Allergan under the Allergan Agreements have been
completed.
For the three months ended March 31, 2022
and 2021, we recognized license revenue of $3.8 million and $12
thousand, respectively. The increase in the current period is due
to a one-time payment of $3.8 million received in March 2022 as
consideration for execution of the Allergan letter agreement.
For the three months ended March 31, 2022 and
2021, we recognized grant revenue of $0 and $0.1 million,
respectively. The related revenue 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 revenues for the three
months ended March 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 three months ended March 31, 2022
and 2021 were $1.9 million and $2.1 million, respectively. The
decrease of $0.2 million was primarily due to decreases in
development costs of our clinical and pre-clinical product
candidates and personnel related expenses, partially offset by
facility rent increases.
General and administrative
expenses for the three months ended March 31, 2022
and 2021 were $2.5 million and $2.3 million, respectively. The
increase of $0.2 million was primarily due to increases in royalty
expenses and legal fees, offset by reductions in personnel related
expenses.
Cash and cash equivalents as of
March 31, 2022 were $17.8 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
the third quarter of 2023.
About Histogen Inc.
Histogen Inc. is a clinical-stage therapeutics
company focused on developing both potential first-in-class
restorative therapeutics that ignite the body’s natural process to
repair and maintain healthy biological function as well as a
pipeline of clinical and preclinical small molecule pan-caspase and
caspase selective inhibitors focused on treatments for infectious
and inflammatory diseases. Under our biologics technology platform,
our product candidates in development are HST-003, a treatment for
joint cartilage repair, and HST-004, a treatment for spinal disc
repair. In addition, within our small molecule pipeline, our
product candidates include emricasan, CTS-2090 and CTS-2096.
Currently, emricasan is being developed jointly with our
collaboration partner, Amerimmune, for the treatment of COVID-19,
and we are evaluating the use of emricasan for other infectious
diseases including the treatment of MRSA. We also have preclinical
product candidates, CTS-2090 and CTS-2096, novel, potent, orally
bioavailable, and highly 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 initiation, completion and
reporting of top line results for HST-003 Phase 1/2 clinical trial
for regeneration of cartilage in the knee, the completion of IND
enabling activities and the anticipated filing of the HST-004 IND
for spinal disc repair and the timing of providing clinical
development guidance on the 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 regain compliance with Nasdaq’s continued listing
requirements; our ability to obtain funding for our operations,
including funding necessary to complete further development and any
commercialization of our product candidates; our expectations
regarding the potential benefits of our strategy and technology,
our expectations regarding the arbitration proceeding related to
emricasan and the joint development with Amerimmune for COVID-19
and other infectious and inflammatory diseases, 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, collaborations and related benefits; our beliefs
regarding the success, cost and timing of our product candidate
development and collaboration activities and current and future
clinical trials and studies; our beliefs regarding the potential
markets for our product candidates, collaborations and our
collaborators’ ability to serve those markets; any impact of the
COVID-19 pandemic, or responses to the pandemic, on our business,
collaborations, 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 expected impact of any
arbitration and litigation proceedings on our business, cash
resources and the time required by management to address such
proceedings. 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, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
— |
|
|
$ |
306 |
|
License revenue |
|
|
3,755 |
|
|
|
12 |
|
Grant revenue |
|
|
— |
|
|
|
113 |
|
Total revenue |
|
|
3,755 |
|
|
|
431 |
|
Operating expense |
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
— |
|
|
|
220 |
|
Research and development |
|
|
1,932 |
|
|
|
2,153 |
|
General and administrative |
|
|
2,506 |
|
|
|
2,331 |
|
Total operating expense |
|
|
4,438 |
|
|
|
4,704 |
|
Loss from
operations |
|
|
(683 |
) |
|
|
(4,273 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(1 |
) |
|
|
(5 |
) |
Net
loss |
|
|
(684 |
) |
|
|
(4,278 |
) |
Loss attributable to noncontrolling interest |
|
|
11 |
|
|
|
8 |
|
Net loss
available to common stockholders |
|
$ |
(673 |
) |
|
$ |
(4,270 |
) |
Net loss per
share available to common stockholders, basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.14 |
) |
Weighted-average number of common shares outstanding used to
compute net loss per share, basic and diluted |
|
|
49,950,212 |
|
|
|
31,571,676 |
|
HISTOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands, except share and per share amounts)
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
17,848 |
|
|
$ |
18,685 |
|
Restricted cash |
|
|
400 |
|
|
|
400 |
|
Accounts receivable, net |
|
|
67 |
|
|
|
165 |
|
Prepaid and other current assets |
|
|
2,694 |
|
|
|
2,359 |
|
Redeemable convertible preferred stock financing proceeds held in
escrow |
|
|
4,762 |
|
|
|
— |
|
Total current assets |
|
|
25,771 |
|
|
|
21,609 |
|
Property and
equipment, net |
|
|
527 |
|
|
|
399 |
|
Right-of-use
asset |
|
|
4,451 |
|
|
|
4,432 |
|
Other
assets |
|
|
748 |
|
|
|
805 |
|
Total assets |
|
$ |
31,497 |
|
|
$ |
27,245 |
|
Liabilities, mezzanine and stockholders’
equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,274 |
|
|
$ |
1,393 |
|
Accrued liabilities |
|
|
1,382 |
|
|
|
791 |
|
Current portion of lease liabilities |
|
|
200 |
|
|
|
127 |
|
Current portion of deferred revenue |
|
|
19 |
|
|
|
19 |
|
Total current liabilities |
|
|
2,875 |
|
|
|
2,330 |
|
Lease
liabilities, non-current |
|
|
4,563 |
|
|
|
4,617 |
|
Noncurrent
portion of deferred revenue |
|
|
94 |
|
|
|
98 |
|
Finance
lease liability, non-current |
|
|
11 |
|
|
|
14 |
|
Total liabilities |
|
|
7,543 |
|
|
|
7,059 |
|
Commitments
and contingencies (Note 8) |
|
|
|
|
|
|
|
|
Mezzanine Equity |
|
|
|
|
|
|
|
|
Redeemable
Convertible Preferred Stock, $0.0001 par value; 10,000,000 shares
authorized at March 31, 2022 and December 31, 2021; 5,000 and 0
shares issued and outstanding at March 31, 2022 and December 31,
2021, respectively |
|
|
4,296 |
|
|
|
— |
|
Total mezzanine equity |
|
|
4,296 |
|
|
|
— |
|
Stockholders' Equity |
|
|
|
|
|
|
|
|
Common
stock, $0.0001 par value; 200,000,000 shares authorized at March
31, 2022 and December 31, 2021; 49,950,212 shares issued and
outstanding at March 31, 2022 and December 31, 2021 |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
98,995 |
|
|
|
98,839 |
|
Accumulated deficit |
|
|
(78,325 |
) |
|
|
(77,652 |
) |
Total Histogen Inc. stockholders’ equity |
|
|
20,675 |
|
|
|
21,192 |
|
Noncontrolling interest |
|
|
(1,017 |
) |
|
|
(1,006 |
) |
Total equity |
|
|
19,658 |
|
|
|
20,186 |
|
Total
liabilities, mezzanine equity, and stockholders’ equity |
|
$ |
31,497 |
|
|
$ |
27,245 |
|
Histogen (NASDAQ:HSTO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Histogen (NASDAQ:HSTO)
Historical Stock Chart
From Sep 2023 to Sep 2024