Miromatrix Medical Inc. (Nasdaq: MIRO) (the “Company”), a life
sciences company pioneering a novel technology for bioengineering
fully transplantable organs to help save and improve patients'
lives, today reported third quarter 2023 financial results.
Due to the Company’s pending proposed
transaction with United Therapeutics Corporation (Nasdaq: UTHR)
(“United Therapeutics”), the Company’s management has suspended
guidance for 2023 and will not hold a conference call to discuss
third quarter 2023 results.
Third Quarter 2023 Financial
Results
Unrestricted cash and investments totaled $16.1
million as of September 30, 2023, compared to $20.4 million as of
June 30, 2023.
Operating loss was $6.6 million and $21.4
million for the three- and nine-month periods ended September 30,
2023, respectively, as compared to $7.8 million and $23.2 million
for the three- and nine- month periods ended September 30, 2022,
respectively. The decrease in operating loss for comparable periods
was primarily attributable to reduced research and development
spending.
Net loss was $6.5 million and $20.5 million for
the three- and nine-month periods ended September 30, 2023,
respectively, as compared to $7.6 million and $23.0 million for the
three- and nine- month periods ended September 30, 2022,
respectively. The decrease in net loss for comparable periods was
primarily attributable to reduced research and development
spending, in addition to a one-time employee retention credit
totaling $0.5 million that was recorded as other income in the
first quarter of 2023.
Miromatrix Agrees to be Acquired by
United Therapeutics Corporation
On October 30, 2023, the Company announced that
it had entered into a definitive merger agreement with United
Therapeutics pursuant to which United Therapeutics would acquire
the Company. United Therapeutics has commenced a tender offer to
acquire all outstanding shares of the Company for a purchase price
of $3.25 per share in cash at closing (an aggregate of
approximately $91 million) and an additional $1.75 per share in
cash upon the achievement of a clinical development milestone
related to the Company’s development-stage, fully-implantable
manufactured kidney product known as mirokidney™ by December 31,
2025. The offer will expire one minute after 11:59 p.m., New York
City time, on December 11, 2023, unless the offer is otherwise
extended or earlier terminated. The Company’s board of directors
has unanimously recommended that the stockholders of the Company
accept the offer and tender their shares.
This transaction is expected to close in the
fourth quarter of 2023, subject to customary closing conditions,
including the tender of a majority of the outstanding shares of the
Company’s common stock.
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.
ADDITIONAL INFORMATION REGARDING THE
PROPOSED TRANSACTION
This communication is neither an offer to
purchase nor a solicitation of an offer to sell any shares of the
common stock of the Company or any other securities. On November
13, 2023, a tender offer statement on Schedule TO, including an
offer to purchase, a letter of transmittal and related documents,
was filed with the Securities and Exchange Commission (the “SEC”),
by United Therapeutics Corporation (“United Therapeutics”) and
Morpheus Subsidiary Inc., and on November 13, 2023, a
Solicitation/Recommendation Statement on Schedule 14D-9 was filed
with the SEC by the Company. The offer to purchase shares of the
Company’s common stock (the “Offer”) is only made pursuant to the
offer to purchase, the letter of transmittal and related documents
filed as a part of the Schedule TO.
INVESTORS AND SECURITY HOLDERS ARE URGED
TO READ CAREFULLY BOTH THE TENDER OFFER MATERIALS (INCLUDING THE
OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN
OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION
STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE
AMENDED FROM TIME TO TIME, BECAUSE THEY CONTAIN IMPORTANT
INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER
BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR
SECURITIES.
Investors and security holders may obtain a free
copy of the Offer to Purchase, the related Letter of Transmittal,
certain other tender offer documents and the
Solicitation/Recommendation Statement and other documents filed
with the SEC at the website maintained by the SEC at www.sec.gov or
by directing such requests to Innisfree M&A Incorporated, the
Information Agent for the tender offer, at (877) 456-3463 (toll
free) or by email at info@innisfreema.com. In addition, United
Therapeutics and the Company file annual, quarterly and current
reports and other information with the SEC, which are available to
the public from commercial document-retrieval services and at the
SEC’s website at www.sec.gov. Copies of the documents filed with
the SEC by United Therapeutics may be obtained at no charge on
United Therapeutics’ internet website at ir.unither.com or by
contacting United Therapeutics at 1000 Spring Street, Silver
Spring, MD 20910 or (301) 608-9292. Copies of the documents filed
with the SEC by the Company may be obtained at no charge on the
Company’s internet website at miromatrix.com or by contacting the
Company at 6455 Flying Cloud Drive, Suite 107, Eden Prairie, MN
55344 or (952) 942-6000.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical
facts are forward looking statements, including statements
regarding the expected closing of United Therapeutics’ acquisition
of the Company and the Company’s technology and its potential
benefits. 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.
MIROMATRIX
MEDICAL INC.Condensed Balance
Sheets
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
(unaudited) |
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,116,084 |
|
|
$ |
5,208,005 |
|
Restricted cash |
|
|
800,100 |
|
|
|
800,100 |
|
Short-term investments |
|
|
9,945,715 |
|
|
|
19,989,489 |
|
Employee retention credit receivable |
|
|
70,000 |
|
|
|
— |
|
Receivable from Reprise Biomedical, Inc. |
|
|
11,176 |
|
|
|
930,355 |
|
Interest receivable |
|
|
9,433 |
|
|
|
107,861 |
|
Prepaid expenses and other current assets |
|
|
239,922 |
|
|
|
274,952 |
|
Total current assets |
|
|
17,192,430 |
|
|
|
27,310,762 |
|
Deferred offering costs |
|
|
— |
|
|
|
232,899 |
|
Right of use asset |
|
|
1,517,956 |
|
|
|
1,673,575 |
|
Property and equipment, net |
|
|
4,710,763 |
|
|
|
5,545,694 |
|
Total assets |
|
$ |
23,421,149 |
|
|
$ |
34,762,930 |
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Current portion of deferred royalties |
|
$ |
862,609 |
|
|
$ |
979,167 |
|
Accounts payable |
|
|
1,048,364 |
|
|
|
1,584,929 |
|
Current portion of financing lease obligations |
|
|
17,281 |
|
|
|
44,157 |
|
Current portion of lease liability |
|
|
413,650 |
|
|
|
389,649 |
|
Accrued expenses |
|
|
2,624,031 |
|
|
|
1,948,376 |
|
Total current liabilities |
|
|
4,965,935 |
|
|
|
4,946,278 |
|
Deferred royalties, net |
|
|
— |
|
|
|
491,733 |
|
Long-term debt |
|
|
385,997 |
|
|
|
385,997 |
|
Financing lease obligations, net |
|
|
— |
|
|
|
11,689 |
|
Lease liability, net |
|
|
2,406,066 |
|
|
|
2,720,781 |
|
Accrued interest |
|
|
120,780 |
|
|
|
99,048 |
|
Total liabilities |
|
|
7,878,778 |
|
|
|
8,655,526 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
Common stock, par value $0.00001; 190,000,000 shares authorized;
27,419,228 issued and outstanding as of
September 30, 2023 and 20,944,109 issued and outstanding
as of December 31, 2022 |
|
|
274 |
|
|
|
209 |
|
Additional paid-in capital |
|
|
140,018,271 |
|
|
|
130,119,106 |
|
Accumulated deficit |
|
|
(124,476,174) |
|
|
|
(104,011,911) |
|
Total shareholders’ equity |
|
|
15,542,371 |
|
|
|
26,107,404 |
|
Total liabilities and shareholders’ equity |
|
$ |
23,421,149 |
|
|
$ |
34,762,930 |
|
MIROMATRIX
MEDICAL INC.Condensed Statements of
Operations(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing revenue |
|
$ |
11,176 |
|
|
$ |
12,395 |
|
|
$ |
27,674 |
|
|
$ |
23,115 |
|
Cost of goods sold |
|
|
125,000 |
|
|
|
125,000 |
|
|
|
375,000 |
|
|
|
375,000 |
|
Gross loss |
|
|
(113,824) |
|
|
|
(112,605) |
|
|
|
(347,326) |
|
|
|
(351,885) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,506,054 |
|
|
|
4,574,534 |
|
|
|
11,519,395 |
|
|
|
13,569,434 |
|
Regulatory and clinical |
|
|
455,313 |
|
|
|
381,903 |
|
|
|
1,259,077 |
|
|
|
1,156,535 |
|
Quality |
|
|
416,476 |
|
|
|
634,511 |
|
|
|
1,515,394 |
|
|
|
1,592,778 |
|
General and administration |
|
|
2,143,421 |
|
|
|
2,052,731 |
|
|
|
6,781,337 |
|
|
|
6,513,748 |
|
Total operating expenses |
|
|
6,521,264 |
|
|
|
7,643,679 |
|
|
|
21,075,203 |
|
|
|
22,832,495 |
|
Operating loss |
|
|
(6,635,088) |
|
|
|
(7,756,284) |
|
|
|
(21,422,529) |
|
|
|
(23,184,380) |
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
196,681 |
|
|
|
143,555 |
|
|
|
464,820 |
|
|
|
205,403 |
|
Interest expense |
|
|
(15,284) |
|
|
|
(15,325) |
|
|
|
(33,697) |
|
|
|
(35,015) |
|
Employee retention credit |
|
|
— |
|
|
|
— |
|
|
|
527,143 |
|
|
|
— |
|
Total other income |
|
|
181,397 |
|
|
|
128,230 |
|
|
|
958,266 |
|
|
|
170,388 |
|
Net loss |
|
$ |
(6,453,691) |
|
|
$ |
(7,628,054) |
|
|
$ |
(20,464,263) |
|
|
$ |
(23,013,992) |
|
Net loss per share, basic and diluted |
|
$ |
(0.24) |
|
|
$ |
(0.37) |
|
|
$ |
(0.80) |
|
|
$ |
(1.11) |
|
Weighted average shares used in computing net loss per share, basic
and diluted |
|
|
27,313,881 |
|
|
|
20,895,513 |
|
|
|
25,714,215 |
|
|
|
20,664,494 |
|
Investor Contact
Greg Chodaczek
347-620-7010
ir@miromatrix.com
Media Contact:
Christina Campbell
612-924-3793
press@miromatrix.com
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