Miromatrix Reports First Quarter 2023 Results and Provides Corporate Update
11 Maggio 2023 - 10:01PM
Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company
pioneering a novel technology for bioengineering fully
transplantable organs to help save and improve patients' lives,
today reported first quarter 2023 financial results and provided a
corporate update.
"Miromatrix remains focused on gaining FDA
clearance to initiate a Phase 1 clinical trial for
miroliverELAP™ in order to treat patients suffering from acute
liver failure," said Jeff Ross, Ph.D., Miromatrix CEO. "We remain
on pace to submit a response to the FDA’s clinical hold letter in
the second half of 2023 relating to our miroliverELAP IND
application; a key step towards becoming the first company to treat
patients with bioengineered organs."
Business Highlights and Corporate
Update
- Confirmed plans to submit a
response to the Food and Drug Administration’s ("FDA") clinical
hold letter pertaining to miroliverELAP in the second half of
2023
- Announced partnership with CareDx,
Inc. to develop novel testing solutions to non-invasively assess
organ rejection for Miromatrix’s pipeline of fully transplantable
bioengineered organs
- Dr. Ross was selected to moderate a
panel at The Cell & Gene Meeting on the Med in Barcelona, Spain
titled "The Pioneer Tax: Challenges and Opportunities of Being at
the Forefront of Innovation"
- Upcoming presentations at the
American Transplant Congress pertaining to mirokidney™ and
miroliverELAP
- Ended the first quarter of 2023
with $25.6 million of unrestricted cash and investments that we
believe will enable us to fund our operations through the second
quarter of 2024
First Quarter 2023 Financial
Results
Unrestricted cash and investments totaled $25.6
million as of March 31, 2023, compared to $25.2 million as of
December 31, 2022.
Operating loss for the first quarter of 2023 was
$8.1 million, compared to $7.2 million in the first quarter of
2022. The increase in operating loss for comparable periods was
primarily attributable to increased research and development costs
and general and administrative costs; notably, cost increases
relating to payroll and the write-off of previously capitalized
deferred offering costs.
Net loss for the first quarter of 2023 was $7.5
million, or $0.33 per share, compared to $7.2 million, or $0.35 per
share in the first quarter of 2022. The increase in net loss for
comparable periods was primarily attributable to the same cost
increases described within operating loss above, offset by a
one-time employee retention credit totalling $0.5 million that was
recorded as income in the first quarter of 2023.
Conference Call and Webcast
Details
The Company will host a live conference call and
webcast to discuss these results and provide a corporate update on
Thursday, May 11, 2023, at 4:30 PM ET.
To participate in the call, please dial
877-407-3982 (domestic) or 201-493-6780 (international) and provide
conference ID 13738056. The live webcast will be available on the
Events & Presentations page of the Investors section of
Miromatrix's website.
About Miromatrix
Miromatrix Medical Inc. is a life sciences
company pioneering a novel technology for bioengineering fully
transplantable human organs to help save and improve patients'
lives. The Company has developed a proprietary perfusion technology
platform for bioengineering organs that it believes will
efficiently scale to address the shortage of available human
organs. The Company's initial development focus is on human livers
and kidneys. For more information, visit miromatrix.com.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements other than statements of
historical facts are forward looking statements, including
statements regarding the potential timing of the filing of the IND
application for our MiroliverELAP product and the initiation of the
related clinical trial. In some cases, you can identify
forward-looking statements by terms such as "may," "will,"
"should," "expect," "plan," "anticipate," "could," "outlook,"
"guidance," "intend," "target," "project," "contemplate,"
"believe," "estimate," "predict," "potential," "continue,"
"remain,” or "on pace" or the negative of these terms or other
similar expressions, although not all forward-looking statements
contain these words. The forward-looking statements in this press
release are only predictions and are based largely on our current
business plans, expectations, and projections about future events
and financial trends that we believe may affect our business,
financial condition, and results of operations. These
forward-looking statements speak only as of the date of this press
release and are subject to a number of known and unknown risks,
uncertainties and assumptions, including, but not limited to, our
history of significant losses, which we expect to continue; our
limited history operating as a commercial company; our expectations
with respect to the regulatory pathway of our product candidates,
our ability to obtain regulatory approvals for such product
candidates, and the anticipated effect of delays in obtaining any
such regulatory approvals; our expectations with respect to
preclinical and clinical trial plans for our product candidates,
the results of such activities and the safety and efficacy of our
product candidates; our ability to commercialize our product
candidates; our ability to compete successfully with larger
competitors in our highly competitive industry; our ability to
achieve and maintain adequate levels of coverage or reimbursement
for any future products we may seek to commercialize; our
expectations regarding our manufacturing capabilities; a pandemic,
epidemic or outbreak of an infectious disease in the U.S. or
worldwide, including the outbreak of the novel strain of
coronavirus, COVID-19; product liability claims; our ability to
establish and maintain intellectual property protection for our
products, as well as our ability to operate our business without
infringing the intellectual property rights of others; our ability
to attract and retain senior management and key scientific
personnel; and other important factors that could cause actual
results, performance or achievements to differ materially from
those expected or projected. For information identifying important
factors that could cause actual results to differ materially from
those anticipated in the forward-looking statements, please refer
to the Risk Factors section of the Company's Form 10-K filed with
the U.S. Securities and Exchange Commission and any additional
risks presented in our Quarterly Reports on Form 10-Q and our
Current Reports on Form 8-K. Except as expressly required by
applicable securities law, the Company disclaims any intention or
obligation to update or revise any forward-looking statements
whether as a result of new information, future events or
otherwise.
Investor ContactGreg
Chodaczek347-620-7010 ir@miromatrix.com
Media
Contact:press@miromatrix.com
MIROMATRIX
MEDICAL INC.Condensed Balance
Sheets
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2023 |
|
2022 |
|
(unaudited) |
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
13,619,898 |
|
|
$ |
5,208,005 |
|
Restricted cash |
|
800,100 |
|
|
|
800,100 |
|
Short-term investments |
|
11,984,842 |
|
|
|
19,989,489 |
|
Employee retention credit receivable |
|
527,143 |
|
|
|
— |
|
Receivable from Reprise Biomedical, Inc. |
|
7,981 |
|
|
|
930,355 |
|
Interest receivable |
|
61,253 |
|
|
|
107,861 |
|
Prepaid expenses and other current assets |
|
346,840 |
|
|
|
274,952 |
|
Total current assets |
|
27,348,057 |
|
|
|
27,310,762 |
|
Deferred offering costs |
|
— |
|
|
|
232,899 |
|
Right of use asset |
|
1,622,706 |
|
|
|
1,673,575 |
|
Property and equipment, net |
|
5,271,306 |
|
|
|
5,545,694 |
|
Total assets |
$ |
34,242,069 |
|
|
$ |
34,762,930 |
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Current portion of deferred royalties |
$ |
616,733 |
|
|
$ |
979,167 |
|
Accounts payable |
|
1,172,342 |
|
|
|
1,584,929 |
|
Current portion of financing lease obligations |
|
33,413 |
|
|
|
44,157 |
|
Current portion of lease liability |
|
397,566 |
|
|
|
389,649 |
|
Accrued expenses |
|
1,105,058 |
|
|
|
1,948,376 |
|
Total current liabilities |
|
3,325,112 |
|
|
|
4,946,278 |
|
Deferred royalties, net |
|
— |
|
|
|
491,733 |
|
Long-term debt |
|
385,997 |
|
|
|
385,997 |
|
Financing lease obligations, net |
|
7,860 |
|
|
|
11,689 |
|
Lease liability, net |
|
2,616,963 |
|
|
|
2,720,781 |
|
Accrued interest |
|
106,118 |
|
|
|
99,048 |
|
Total liabilities |
|
6,442,050 |
|
|
|
8,655,526 |
|
Commitments and
contingencies |
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
Common stock, par value $0.00001; 190,000,000 shares authorized;
27,239,938 issued and outstanding as of March 31, 2023
and 20,944,109 issued and outstanding as of
December 31, 2022 |
|
272 |
|
|
|
209 |
|
Additional paid-in capital |
|
139,291,810 |
|
|
|
130,119,106 |
|
Accumulated deficit |
|
(111,492,063 |
) |
|
|
(104,011,911 |
) |
Total shareholders’ equity |
|
27,800,019 |
|
|
|
26,107,404 |
|
Total liabilities and shareholders’ equity |
$ |
34,242,069 |
|
|
$ |
34,762,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MIROMATRIX
MEDICAL INC.Condensed Statements of
Operations(Unaudited)
|
|
|
Three Months Ended March 31, |
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Licensing revenue |
$ |
7,981 |
|
|
$ |
6,768 |
|
Cost of goods sold |
|
125,000 |
|
|
|
125,000 |
|
Gross loss |
|
(117,019 |
) |
|
|
(118,232 |
) |
Operating expenses: |
|
|
|
|
|
Research and development |
|
4,392,118 |
|
|
|
4,006,666 |
|
Regulatory and clinical |
|
406,315 |
|
|
|
355,238 |
|
Quality |
|
583,342 |
|
|
|
440,935 |
|
General and administration |
|
2,600,235 |
|
|
|
2,272,557 |
|
Total operating expenses |
|
7,982,010 |
|
|
|
7,075,396 |
|
Operating loss |
|
(8,099,029 |
) |
|
|
(7,193,628 |
) |
Other income (expense) |
|
|
|
|
|
Interest income |
|
101,977 |
|
|
|
770 |
|
Interest expense |
|
(10,243 |
) |
|
|
(10,891 |
) |
Employee retention credit |
|
527,143 |
|
|
|
— |
|
Total other income (expense) |
|
618,877 |
|
|
|
(10,121 |
) |
Net loss |
$ |
(7,480,152 |
) |
|
$ |
(7,203,749 |
) |
Net loss per share, basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.35 |
) |
Weighted average shares used in computing net loss per share, basic
and diluted |
|
22,508,244 |
|
|
|
20,478,164 |
|
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