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Miromatrix Reports Third Quarter 2021 Results

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Miromatrix Medical Inc. (NASDAQ: MIRO) reported its Q3 2021 financial results, highlighting significant advancements in bioengineering transplantable organs. Key achievements included raising approximately $49 million through an IPO and hiring Dr. John Barry as the new VP of Research and Development. The company successfully transplanted a bioengineered organ in a large animal and is preparing for a 2022 FDA IND submission for its Phase I Liver Assist Trial. Despite a revenue of $10,000 and a net loss of $5.1 million, cash reserves stood strong at $62.1 million.

Positive
  • Raised approximately $49 million in IPO proceeds.
  • Hired accomplished scientist Dr. John Barry as VP of R&D.
  • Successfully transplanted a bioengineered whole organ in a large animal.
  • Strengthening infrastructure for 2022 FDA IND submission and Phase I trial.
Negative
  • Revenue remains low at $10,000 for Q3 2021.
  • Net loss increased to $5.1 million from $3.0 million in Q3 2020.
  • Operating expenses rose significantly to $5.1 million due to various factors.

EDEN PRAIRIE, Minn., Nov. 15, 2021 (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 2021 financial results.

Business Highlights

  • Completed an initial public offering of 5.5 million shares, raising approximately $49 million in gross proceeds;
  • Hired accomplished scientist and product developer, Dr. John Barry, as Vice President of Research and Development;
  • Announced the first successful transplant of a bioengineered whole organ in a large animal; and
  • Strengthening infrastructure in support of 2022 FDA IND submission and commencement of Phase I Liver Assist Trial

"Throughout the third quarter, we made meaningful progress towards our ultimate goal of bioengineering fully transplantable human organs," said Jeff Ross, Ph.D., Miromatrix CEO. "2022 will be an exciting year for Miromatrix as we prepare for our FDA Investigational New Drug Application submission and the eventual enrollment for our Phase I Liver Assist Trial. With the demand for organs ever-increasing, we are very eager to demonstrate the viability and efficacy of our bioengineered fully transplantable organs through our upcoming clinical trial."

Third Quarter 2021 Financial Results

Revenue was $10,000 for the third quarter of 2021, stemming from our license agreement with Reprise Biomedical for MIROMESH® and MIRODERM®.

Loss on gross margin was $0.1 million for the third quarter of 2021 and 2020.

Operating expenses were $5.1 million in the third quarter of 2021, compared to $2.5 million in the same period in 2020. The increase was primarily due to increased headcount, increased research and development supplies costs as we accelerate our development efforts and building stocks to help avoid supply constraints, as well the cost of being a public company.

Net loss was $5.1 million in the third quarter of 2021, compared to a net loss of $3.0 million in the same period in 2020.

Cash and Cash Equivalents at September 30, 2021 were $62.1 million.

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 15, 2021, at 4:30 PM ET.

To participate in the call, please dial (844) 825-9789 (domestic) or (412) 317-6011 (international) and provide conference ID 10161624. 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 our first ever transplant of a bioengineered liver transplant into a large animal. 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

       
  September 30,  December 31, 
     2021
 2020
       
  (unaudited)      
ASSETS      
Current assets:      
Cash and cash equivalents $62,087,678  $4,444,395 
Receivable from Reprise Biomedical, Inc.  9,819   15,202 
Grant receivable  115,530   100,000 
Prepaid expenses and other current assets  334,310   130,576 
Total current assets  62,547,337   4,690,173 
Lab equipment, furniture, leasehold improvements and construction in progress, net  1,678,648   324,534 
Investment in Reprise Biomedical, Inc     239,721 
Total assets $64,225,985  $5,254,428 
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)      
Current liabilities:      
Current portion of long-term debt $386,161  $6,413,733 
Accounts payable  1,249,259   130,160 
Accrued interest expense     612,705 
Embedded derivative liability     246,962 
Accrued expenses  1,922,617   760,889 
Total current liabilities  3,558,037   8,164,449 
Accrued royalties  857,101   488,368 
Long-term debt, less current portion  478,766   928,623 
Accrued interest  65,032   45,691 
Total liabilities  4,958,936   9,627,131 
Commitments and contingencies      
Mezzanine equity:      
Convertible preferred stock – Series B-2, par value $0.00001; 0 shares authorized, issued and outstanding as of September 30, 2021 and 2,500,000 shares authorized; 2,095,874 issued and outstanding as of December 31, 2020 (Liquidation preference $0 and $15,719,055, respectively)     15,670,097 
Convertible preferred stock – Series B, par value $0.00001; 0 shares authorized, issued and outstanding as of September 30, 2021 and 4,000,000 shares authorized; 3,218,282 issued and outstanding as of December 31, 2020 (Liquidation preference $0 and $24,137,115, respectively)     23,865,732 
Convertible preferred stock – Series A, par value $0.00001; 0 shares authorized, issued and outstanding as of September 30, 2021 and 3,300,000 shares authorized; 3,000,380 issued and outstanding as of December 31, 2020 (Liquidation preference $0 and $7,500,950, respectively)     7,125,661 
Shareholders’ equity (deficit):      
Common stock, par value $0.00001; 190,000,000 shares authorized; 20,254,645 issued and outstanding as of September 30, 2021 and 30,000,000 shares authorized; 2,185,822 issued and outstanding as of December 31, 2020  202   22 
Additional paid-in capital  127,842,762   8,346,943 
Accumulated deficit  (68,575,915)  (59,381,158)
Total shareholders’ equity (deficit)  59,267,049   (51,034,193)
Total Liabilities, Mezzanine Equity and Shareholders’ Equity (Deficit) $64,225,985  $5,254,428 

The accompanying notes are an integral part of these condensed financial statements.


MIROMATRIX MEDICAL INC.

Condensed Statements of Operations
(Unaudited)

             
  Three Months Ended  Nine Months Ended
  September 30,  September 30, 
  2021
 2020
 2021
 2020
             
Licensing revenue $9,819  $10,846  $25,066  $31,328 
Cost of goods sold  125,000   125,000   375,000   375,000 
Gross margin  (115,181)  (114,154)  (349,934)  (343,672)
Operating expenses:            
Research & development  3,349,898   1,870,039   7,698,786   5,750,320 
Regulatory and clinical  105,208   64,083   292,169   208,276 
Quality  150,675   75,850   322,719   75,850 
General & administration  1,487,654   460,105   2,836,850   1,530,915 
Total operating expenses  5,093,435   2,470,077   11,150,524   7,565,361 
Operating loss  (5,208,616)  (2,584,231)  (11,500,458)  (7,909,033)
Interest income  766   94   851   8,683 
Interest expense  (15,255)  (208,926)  (601,292)  (363,444)
Amortization of discount on note     (32,586)  (62,638)  (76,034)
Change in fair value of derivative        246,962    
Research grants  115,069   328,424   393,034   794,291 
Equity loss in affiliate     (495,000)  (223,633)  (1,676,000)
Gain on sale of equity investment        1,983,912    
Gain on debt extinguishment  50,455      568,505    
Net loss $(5,057,581) $(2,992,225) $(9,194,757) $(9,221,537)
Net loss per share, basic and diluted $(0.25) $(1.37) $(1.08) $(4.27)
Weighted average shares used in computing net loss per share, basic and diluted  20,145,321   2,183,322   8,503,743   2,158,632 

The accompanying notes are an integral part of these condensed financial statements.


FAQ

What were Miromatrix's financial results for Q3 2021?

Miromatrix reported a revenue of $10,000 and a net loss of $5.1 million for Q3 2021.

How much money did Miromatrix raise in its IPO?

Miromatrix raised approximately $49 million in its initial public offering.

Who was hired as VP of Research and Development at Miromatrix?

Dr. John Barry was hired as the new VP of Research and Development.

What clinical trial is Miromatrix preparing for in 2022?

Miromatrix is preparing for a Phase I Liver Assist Trial and the FDA IND submission.

What were Miromatrix's cash reserves at the end of Q3 2021?

Miromatrix had cash and cash equivalents of $62.1 million as of September 30, 2021.

Miromatrix Medical Inc.

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