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Miromatrix Reports Filing of IND, Third Quarter 2022 Results, and Provides Corporate Update

EDEN PRAIRIE, Minn., Nov. 14, 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 third quarter 2022 financial results and provided a corporate update.

"Miromatrix is excited to announce that we recently submitted our IND for miroliverELAP™," said Jeff Ross, Ph.D., Miromatrix CEO. "We believe this is the first IND to be submitted to the FDA for a bioengineered organ. I am incredibly proud of our entire team for achieving this important milestone and putting us one step closer to our goal of treating patients with our bioengineered organs and eliminating the organ transplant waiting list."

Business Highlights

  • Submitted IND application for miroliverELAP, our external liver assist product. Following IND clearance from the FDA we plan to initiate a Phase 1 clinical trial
  • Continued progress in the pre-clinical development of miroliver™ and mirokidney™, our fully implantable bioengineered livers and kidneys
  • Finalist for KidneyX Winner Showcase at ASN Kidney Week which is a partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN)
  • Received notice of allowance from USPTO for patent covering the revascularization of decellularized organs and tissues that encompasses all types of organs
  • Appointed renowned transplant surgeon, Jack Lake, M.D., as Medical Director
  • Ended the third quarter of 2022 with $31.5 million of cash and investments; we continue to believe that our cash balance is sufficient to last through December 2023

Third Quarter and Year-to-Date 2022 Financial Results

Cash and investments totaled $31.5 million as of September 30, 2022, as compared to $38.6 million as of June 30, 2022.

Operating loss was $7.8 million and $23.2 million for the three- and nine-month periods ended September 30, 2022, respectively, as compared to $5.2 million and $11.5 million for the three- and nine-month periods ended September 30, 2021. 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 being a public company, payroll, and lab supplies.

Net loss was $7.6 million, or $0.37 per share, and $23.0 million, or $1.11 per share for the three- and nine-month periods ended September 30, 2022, respectively, as compared to $5.1 million, or $0.25 per share, and $9.2 million, or $1.08 per share for the three- and nine-month periods ended September 30, 2021. The increase in net loss for comparable periods was primarily attributable to the same cost increases described within operating loss above, plus one-time gains recognized in the first quarter of 2021 that impact the nine-month period comparison. The increase in share count for the nine-month comparable periods is attributable to the issuance of IPO shares in June 2021.

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, November 14, 2022, at 4:30 PM ET.

To participate in the call, please dial 877-407-3982 (domestic) or +1-201-493-6780 (international) and provide conference ID 13732863. 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

Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward‐looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would," and "future," or similar expressions, are intended to identify forward‐looking statements. Each of these forward‐looking statements involves substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by such forward‐looking statements. Forward‐looking statements contained in this press release include, but are not limited to, statements regarding the initiation, timing, progress and results of our current and future preclinical studies and future clinical trials, including statements regarding the potential timing of the clearance of the IND application and other regulatory documents for our miroliverELAP™ product candidate and the potential timing of pre-IND meetings or submissions of regulatory documents for our mirokidney™ and miroliver™ product candidates; the initiation of the related clinical trials; the expected timing of program updates and data disclosures; statements regarding the timing and likelihood of seeking regulatory approval for our product candidates; the competitive landscape for our product candidates; and our estimates regarding expenses, future revenue, capital requirements, cash runway and needs for additional financing. These forward‐looking statements reflect our current beliefs and expectations. ​

​There are several important factors that could cause our actual results to differ materially from those indicated by such forward looking statements, including a deterioration in our business or prospects; further assessment of preliminary data, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and completion of clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, including our ability to obtain regulatory clearance to commence clinical trials, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of our product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID- 19), and geopolitical risks, including the current war between Russian and Ukraine. These risks are not exhaustive, we face known and unknown risks. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and our subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.

Investor Contact
Greg Chodaczek

Media Contact:

Condensed Balance Sheets

  September 30,  December 31, 
     2022  2021 
Current assets:      
Cash and cash equivalents $5,537,818  $52,811,531 
Restricted cash  800,100   800,100 
Short-term investments  26,003,087    
Receivable from Reprise Biomedical, Inc.  12,395   17,819 
Interest receivable  121,287    
Tenant improvement allowance receivable     1,256,950 
Prepaid expenses and other current assets  360,615   450,873 
Total current assets  32,835,302   55,337,273 
Deferred offering costs  232,899    
Right of use asset  1,723,479    
Property and equipment, net  5,816,028   5,591,726 
Total assets $40,607,708  $60,928,999 
Liabilities and Shareholders' Equity      
Current liabilities:      
Current portion of long-term debt $15,417  $333,849 
Current portion of deferred royalties  857,589   488,368 
Accounts payable  1,157,652   2,094,854 
Current portion of financing lease obligations  52,911   58,037 
Current portion of lease liability  381,925    
Current portion of tenant improvement obligation     160,462 
Accrued expenses  1,592,601   1,428,622 
Total current liabilities  4,058,095   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  17,282   52,768 
Lease liability, net  2,819,716    
Tenant improvement obligation, net     1,029,629 
Accrued interest  92,094   71,592 
Total liabilities  7,864,917   6,803,115 
Commitments and contingencies      
Shareholders’ equity:      
Common stock, par value $0.00001; 190,000,000 shares authorized; 20,904,295 issued and outstanding as of September 30, 2022 and 20,385,645 issued and outstanding as of December 31, 2021  209   204 
Additional paid-in capital  129,808,488   128,177,594 
Accumulated deficit  (97,065,906)  (74,051,914)
Total shareholders’ equity  32,742,791   54,125,884 
Total liabilities and shareholders’ equity $40,607,708  $60,928,999 

Condensed Statements of Operations

  Three Months Ended  Nine Months Ended
  September 30,  September 30, 
  2022 2021 2022 2021
Licensing revenue $12,395  $9,819  $23,115  $25,066 
Cost of goods sold  125,000   125,000   375,000   375,000 
Gross loss  (112,605)  (115,181)  (351,885)  (349,934)
Operating expenses:            
Research and development  4,574,534   3,349,898   13,569,434   7,698,786 
Regulatory and clinical  381,903   105,208   1,156,535   292,169 
Quality  634,511   150,675   1,592,778   322,719 
General and administration  2,052,731   1,487,654   6,513,748   2,836,850 
Total operating expenses  7,643,679   5,093,435   22,832,495   11,150,524 
Operating loss  (7,756,284)  (5,208,616)  (23,184,380)  (11,500,458)
Interest income  143,555   766   205,403   851 
Interest expense  (15,325)  (15,255)  (35,015)  (601,292)
Amortization of discount on note           (62,638)
Change in fair value of derivative           246,962 
Research grants     115,069      393,034 
Equity loss in affiliate           (223,633)
Gain on sale of equity investment           1,983,912 
Gain on debt extinguishment     50,455      568,505 
Net loss $(7,628,054) $(5,057,581) $(23,013,992) $(9,194,757)
Net loss per share, basic and diluted $(0.37) $(0.25) $(1.11) $(1.08)
Weighted average shares used in computing net loss per share, basic and diluted  20,895,513   20,145,321   20,664,494   8,503,743 

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