"Miromatrix remains on pace to submit a response to the FDA’s clinical hold letter relating to our miroliverELAPtm IND application in the second half of 2023," said
Business Highlights and Corporate Update
- Confirmed plans to submit a response to the
Food and Drug Administration ("FDA") clinical hold letter pertaining to miroliverELAP in the second half of 2023 - Nearing completion of in-life portion of animal safety study and biocompatibility study to address issues identified in the miroliverELAP clinical hold letter
- Presented three posters at 2023
American Transplant Congress ("ATC") and was awarded Best inCongress for a mirokidneytm poster - Participated in National Kidney Foundation’s ("NKF") Innovation Day congressional event
- Participated in
Association of Organ Procurement Organizations ("AOPO") annual meeting panel titled Saving Lives Through Telepathology and Bioengineering - Represented cell & gene therapy sector to
Capitol Hill policy makers atAlliance for Regenerative Medicine ("ARM") Congressional Fly-In - Published manuscript titled “Sustained in vivo perfusion of a re-endothelialized tissue engineered kidney graft in a human-scale animal model,” in Frontiers in Bioengineering and Biotechnology
- Ended the second quarter of 2023 with
$20.4 million of unrestricted cash and investments that we believe will enable us to fund our operations through the second quarter of 2024
Second Quarter 2023 Financial Results
Unrestricted cash and investments totaled
Operating loss was
Net loss was
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
To participate in the call, please dial 866-652-5200 (domestic) or 412-317-6060 (international) and provide conference ID 10181369. The live webcast will be available on the Events & Presentations page of the Investors section of Miromatrix's website.
About Miromatrix
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
Investor Contact
347-620-7010
ir@miromatrix.com
Media Contact:
612-924-3793
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MIROMATRIX MEDICAL INC.
Condensed Balance Sheets
2023 | 2022 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,571,777 | $ | 5,208,005 | ||||
Restricted cash | 800,100 | 800,100 | ||||||
Short-term investments | 15,828,281 | 19,989,489 | ||||||
Employee retention credit receivable | 527,143 | — | ||||||
Receivable from | 8,517 | 930,355 | ||||||
Interest receivable | 30,707 | 107,861 | ||||||
Prepaid expenses and other current assets | 114,943 | 274,952 | ||||||
Total current assets | 21,881,468 | 27,310,762 | ||||||
Deferred offering costs | — | 232,899 | ||||||
Right of use asset | 1,570,837 | 1,673,575 | ||||||
Property and equipment, net | 4,998,862 | 5,545,694 | ||||||
Total assets | $ | 28,451,167 | $ | 34,762,930 | ||||
Liabilities and Shareholders' Equity | ||||||||
Current liabilities: | ||||||||
Current portion of deferred royalties | $ | 739,738 | $ | 979,167 | ||||
Accounts payable | 803,571 | 1,584,929 | ||||||
Current portion of financing lease obligations | 22,506 | 44,157 | ||||||
Current portion of lease liability | 405,566 | 389,649 | ||||||
Accrued expenses | 1,916,104 | 1,948,376 | ||||||
Total current liabilities | 3,887,485 | 4,946,278 | ||||||
Deferred royalties, net | — | 491,733 | ||||||
Long-term debt | 385,997 | 385,997 | ||||||
Financing lease obligations, net | 3,964 | 11,689 | ||||||
Lease liability, net | 2,512,062 | 2,720,781 | ||||||
Accrued interest | 113,409 | 99,048 | ||||||
Total liabilities | 6,902,917 | 8,655,526 | ||||||
Commitments and contingencies | ||||||||
Shareholders’ equity: | ||||||||
Common stock, par value | 273 | 209 | ||||||
Additional paid-in capital | 139,570,460 | 130,119,106 | ||||||
Accumulated deficit | (118,022,483 | ) | (104,011,911 | ) | ||||
Total shareholders’ equity | 21,548,250 | 26,107,404 | ||||||
Total liabilities and shareholders’ equity | $ | 28,451,167 | $ | 34,762,930 | ||||
MIROMATRIX MEDICAL INC.
Condensed Statements of Operations
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Licensing revenue | $ | 8,517 | $ | 3,952 | $ | 16,498 | $ | 10,720 | ||||||||
Cost of goods sold | 125,000 | 125,000 | 250,000 | 250,000 | ||||||||||||
Gross loss | (116,483 | ) | (121,048 | ) | (233,502 | ) | (239,280 | ) | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 3,621,224 | 4,988,233 | 8,013,342 | 8,994,899 | ||||||||||||
Regulatory and clinical | 397,448 | 419,394 | 803,763 | 774,632 | ||||||||||||
Quality | 515,575 | 517,333 | 1,098,917 | 958,268 | ||||||||||||
General and administration | 2,037,682 | 2,188,460 | 4,637,917 | 4,461,017 | ||||||||||||
Total operating expenses | 6,571,929 | 8,113,420 | 14,553,939 | 15,188,816 | ||||||||||||
Operating loss | (6,688,412 | ) | (8,234,468 | ) | (14,787,441 | ) | (15,428,096 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Interest income | 166,162 | 61,078 | 268,139 | 61,848 | ||||||||||||
Interest expense | (8,170 | ) | (8,799 | ) | (18,413 | ) | (19,690 | ) | ||||||||
Employee retention credit | — | — | 527,143 | — | ||||||||||||
Total other income | 157,992 | 52,279 | 776,869 | 42,158 | ||||||||||||
Net loss | $ | (6,530,420 | ) | $ | (8,182,189 | ) | $ | (14,010,572 | ) | $ | (15,385,938 | ) | ||||
Net loss per share, basic and diluted | $ | (0.24 | ) | $ | (0.40 | ) | $ | (0.56 | ) | $ | (0.75 | ) | ||||
Weighted average shares used in computing net loss per share, basic and diluted | 27,250,573 | 20,615,218 | 24,897,796 | 20,547,070 |
Source:
2023 GlobeNewswire, Inc., source