EDEN PRAIRIE, Minn., May 16, 2022 (GLOBE NEWSWIRE) -- 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 2022 financial results and provided a corporate update.
"We continue to focus our efforts on advancing our bioengineered organs towards human clinical trials," said Jeff Ross, Ph.D., Miromatrix CEO. "The need for organ transplants constantly grows and Miromatrix is proud to be developing bioengineered organs that could be a solution for countless patients."
Business Highlights
- Ended the first quarter of 2022 with $44.7 million of cash which reflects $1.7 million of one-time cash outlays in the quarter related to the build-out of our new headquarters. We continue to believe our cash balance is sufficient to last through 2023
- On track to file IND application for MiroliverELAP™, our external liver assist product, in the second half of 2022, after which we believe we will receive FDA clearance to initiate a Phase 1 clinical trial
- Continued pre-clinical development of Miroliver™ and Mirokidney™, our fully implantable bioengineered livers and kidneys
Miromatrix also announces the departure of Laji Kattungal, Vice President of Quality, who will be transitioning from Miromatrix at the end of July for health and personal reasons and a search has commenced for his replacement. "We appreciate Laji’s significant contributions to Miromatrix," said Dr. Ross. "As a multi-organ transplant recipient he has consistently been a driving force behind our mission to deliver bioengineered organs to patients in need. We are pleased that Laji will continue to lead the Quality team as we search for his successor to ensure a seamless transition."
First Quarter 2022 Financial Results
Cash and cash equivalents totaled $44.7 million as of March 31, 2022 compared to $52.8 million as of December 31, 2021. The March 31, 2022 cash balance reflects $1.7 million of one-time cash outlays in the quarter related to the build-out of our new headquarters.
Operating loss was $7.2 million in the first quarter of 2022, compared to $2.7 million in the same period in 2021. The increase in operating loss was primarily attributable to increased general and administrative costs and research and development costs, relating to increases in headcount, pre-clinical supplies and services, and costs of being a public company.
Net loss was $7.2 million in the first quarter of 2022, compared to a net loss of $0.4 million in the same period in 2021. The increase in net loss was primarily attributable to the increase in operating loss, plus one-time gains recognized in 2021 that did not occur in 2022.
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 Monday, May 16, 2022, 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 13729510. 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" or "continue" 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 ability to compete successfully with larger competitors in our highly competitive industry; 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 Registration Statement on Form S-1 (File No. 333-256649), as amended, 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 Contact
Greg Chodaczek
347-620-7010
ir@miromatrix.com
Media Contact:
press@miromatrix.com
MIROMATRIX MEDICAL INC.
Condensed Balance Sheets
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 44,684,677 | $ | 52,811,531 | ||||
| Restricted cash | 800,100 | 800,100 | ||||||
| Receivable from Reprise Biomedical, Inc. | 6,768 | 17,819 | ||||||
| Tenant improvement allowance receivable | — | 1,256,950 | ||||||
| Prepaid expenses and other current assets | 652,226 | 450,873 | ||||||
| Total current assets | 46,143,771 | 55,337,273 | ||||||
| Right of use asset | 1,820,900 | — | ||||||
| Property and equipment, net | 5,992,237 | 5,591,726 | ||||||
| Total assets | $ | 53,956,908 | $ | 60,928,999 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Current portion of long-term debt | $ | 61,209 | $ | 333,849 | ||||
| Current portion of deferred royalties | 611,676 | 488,368 | ||||||
| Accounts payable | 478,866 | 2,094,854 | ||||||
| Current portion of financing lease obligations | 57,029 | 58,037 | ||||||
| Current portion of lease liability | 284,348 | — | ||||||
| Current portion of tenant improvement obligation | — | 160,462 | ||||||
| Accrued expenses | 995,900 | 1,428,622 | ||||||
| Total current liabilities | 2,489,028 | 4,564,192 | ||||||
| Deferred royalties, net | 491,733 | 491,733 | ||||||
| Long-term debt | 385,997 | 385,997 | ||||||
| Deferred rent | — | 207,204 | ||||||
| Financing lease obligations, net | 40,069 | 52,768 | ||||||
| Lease liability, net | 3,014,530 | — | ||||||
| Tenant improvement obligation, net | — | 1,029,629 | ||||||
| Accrued interest | 78,262 | 71,592 | ||||||
| Total liabilities | 6,499,619 | 6,803,115 | ||||||
| Commitments and contingencies | ||||||||
| Shareholders’ equity: | ||||||||
| Common stock, par value $0.00001; 190,000,000 shares authorized; 20,546,583 issued and outstanding as of March 31, 2022 and 20,385,645 issued and outstanding as of December 31, 2021 | 206 | 204 | ||||||
| Additional paid-in capital | 128,712,746 | 128,177,594 | ||||||
| Accumulated deficit | (81,255,663 | ) | (74,051,914 | ) | ||||
| Total shareholders’ equity | 47,457,289 | 54,125,884 | ||||||
| Total Liabilities and Shareholders’ Equity | $ | 53,956,908 | $ | 60,928,999 | ||||
MIROMATRIX MEDICAL INC.
Condensed Statements of Operations
(Unaudited)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Licensing revenue | $ | 6,768 | $ | 6,108 | ||||
| Cost of goods sold | 125,000 | 125,000 | ||||||
| Gross loss | (118,232 | ) | (118,892 | ) | ||||
| Operating expenses: | ||||||||
| Research and development | 4,005,908 | 1,868,001 | ||||||
| Regulatory and clinical | 355,238 | 83,705 | ||||||
| Quality | 440,935 | 85,787 | ||||||
| General and administration | 2,272,557 | 562,874 | ||||||
| Total operating expenses | 7,074,638 | 2,600,367 | ||||||
| Operating loss | (7,192,870 | ) | (2,719,259 | ) | ||||
| Interest income | 770 | 40 | ||||||
| Interest expense | (10,891 | ) | (305,374 | ) | ||||
| Loss on disposal of property and equipment | (758 | ) | — | |||||
| Amortization of discount on note | — | (32,586 | ) | |||||
| Change in fair value of derivative | — | 193,971 | ||||||
| Research grants | — | 150,537 | ||||||
| Equity loss in affiliate | — | (223,633 | ) | |||||
| Gain on sale of equity investment | — | 1,983,912 | ||||||
| Gain on debt extinguishment | — | 518,050 | ||||||
| Net loss | $ | (7,203,749 | ) | $ | (434,342 | ) | ||
| Net loss per share, basic and diluted | $ | (0.35 | ) | $ | (0.19 | ) | ||
| Weighted average shares used in computing net loss per share, basic and diluted | 20,478,164 | 2,255,378 | ||||||
