EX-99.1 2 tmb-20220815xex99d1.htm EX-99.1

Exhibit 99.1

Logo, company name

Description automatically generated

Miromatrix Reports Second Quarter 2022 Results and Provides Corporate Update

EDEN PRAIRIE, MN, August 15, 2022 - 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 second quarter 2022 financial results and provided a corporate update.

"Each quarter, Miromatrix makes meaningful progress towards our goal of improving the lives of transplant patients with our bioengineered organs,” said Jeff Ross, Ph.D., Miromatrix CEO. "The need for viable transplant organs continues to grow and Miromatrix remains at the forefront of companies dedicated to developing alternatives to human-donor organ transplants".

Business Highlights

Ended the second quarter of 2022 with $38.6 million of cash and investments. We continue to believe that our cash balance is sufficient to last through 2023.
On track to file IND application for MiroliverELAP, our external liver assist product, before year-end. Following IND clearance from the FDA, we plan to initiate a Phase 1 clinical trial.
Successfully bioengineered kidneys that demonstrated urine production and protein retention in our preclinical bench testing model. We believe this is the first time a bioengineered organ has produced urine and we plan to publish these findings in the near future.
Bioengineered more than 400 livers and kidneys this year at our new fully-integrated headquarters. This highlights the talent of our scientific team and manufacturing capabilities as we move towards clinical trials.
Continued pre-clinical development of Miroliver™ and Mirokidney™, our fully implantable bioengineered livers and kidneys.

Second Quarter and Year-to-Date 2022 Financial Results

Cash and investments totaled $38.6 million as of June 30, 2022, as compared to $44.7 million as of March 31, 2022.


Operating loss was $8.2 million and $15.4 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $3.6 million and $6.3 million for the three- and six-month periods ended June 30, 2021. The increase in operating loss for comparable periods was primarily attributable to increased research and development costs and general and administrative costs; specifically, cost increases relating to payroll, pre-clinical lab supplies and services, as well as increased costs associated with being a public company.

Net loss was $8.2 million, or $0.40 per share, and $15.4 million, or $0.75 per share for the three- and six-months ended June 30, 2022, respectively, as compared to $3.7 million, or $1.27 per share, and $4.1 million, or $1.60 per share for the three- and six-months ended June 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 six month period comparison. The reduction in net loss per share for comparable periods was largely attributable to the significant increase in weighted average shares outstanding resulting from the Company’s IPO 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, August 15, 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 13730782. 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 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.

Investor Contact

Greg Chodaczek

347-620-7010

ir@miromatrix.com

Media Contact:

press@miromatrix.com


MIROMATRIX MEDICAL INC.

Condensed Balance Sheets

June 30, 

December 31, 

    

2022

2021

(unaudited)

    

Assets

Current assets:

Cash and cash equivalents

$

12,593,315

$

52,811,531

Restricted cash

800,100

800,100

Short-term investments

20,080,428

Receivable from Reprise Biomedical, Inc.

 

3,952

17,819

Interest receivable

116,933

Tenant improvement allowance receivable

1,256,950

Prepaid expenses and other current assets

 

364,649

450,873

Total current assets

 

33,959,377

55,337,273

Investments

5,938,963

Deferred offering costs

 

191,233

Right of use asset

1,772,441

Property and equipment, net

 

5,792,166

5,591,726

Total assets

$

47,654,180

$

60,928,999

Liabilities and Shareholders' Equity

Current liabilities:

Current portion of long-term debt

$

38,399

$

333,849

Current portion of deferred royalties

735,688

488,368

Accounts payable

 

1,078,690

 

2,094,854

Current portion of financing lease obligations

57,848

58,037

Current portion of lease liability

374,280

Current portion of tenant improvement obligation

160,462

Accrued expenses

 

1,450,934

 

1,428,622

Total current liabilities

 

3,735,839

 

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

26,469

52,768

Lease liability, net

2,917,628

Tenant improvement obligation, net

1,029,629

Accrued interest

 

85,216

 

71,592

Total liabilities

 

7,642,882

 

6,803,115

Commitments and contingencies

Shareholders’ equity:

Common stock, par value $0.00001; 190,000,000 shares authorized; 20,813,741 issued and outstanding as of June 30, 2022 and 20,385,645 issued and outstanding as of December 31, 2021

 

208

 

204

Additional paid-in capital

 

129,448,942

 

128,177,594

Accumulated deficit

 

(89,437,852)

 

(74,051,914)

Total shareholders’ equity

 

40,011,298

 

54,125,884

Total Liabilities and Shareholders’ Equity

$

47,654,180

$

60,928,999


MIROMATRIX MEDICAL INC.

Condensed Statements of Operations

(Unaudited)

    

Three Months Ended

 

Six Months Ended

June 30, 

 

June 30, 

2022

    

2021

    

2022

    

2021

Licensing revenue

$

3,952

$

9,139

$

10,720

$

15,247

Cost of goods sold

 

125,000

 

125,000

 

250,000

 

250,000

Gross loss

 

(121,048)

 

(115,861)

 

(239,280)

 

(234,753)

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

4,988,233

 

2,480,887

 

8,994,141

 

4,348,888

Regulatory and clinical

 

419,394

 

103,256

 

774,632

 

186,961

Quality

 

517,333

 

86,257

 

958,268

 

172,044

General and administration

 

2,188,460

 

786,322

 

4,461,775

 

1,349,196

Total operating expenses

 

8,113,420

 

3,456,722

 

15,188,816

 

6,057,089

Operating loss

 

(8,234,468)

 

(3,572,583)

 

(15,428,096)

 

(6,291,842)

Interest income

 

61,078

 

45

 

61,848

 

85

Interest expense

 

(8,799)

 

(280,663)

 

(19,690)

 

(586,037)

Amortization of discount on note

 

 

(30,052)

 

 

(62,638)

Change in fair value of derivative

 

 

52,991

 

 

246,962

Research grants

 

 

127,428

 

 

277,965

Equity loss in affiliate

 

 

 

 

(223,633)

Gain on sale of equity investment

 

 

 

 

1,983,912

Gain on debt extinguishment

 

 

 

 

518,050

Net loss

$

(8,182,189)

$

(3,702,834)

$

(15,385,938)

$

(4,137,176)

Net loss per share, basic and diluted

$

(0.40)

$

(1.27)

$

(0.75)

$

(1.60)

Weighted average shares used in computing net loss per share, basic and diluted

 

20,615,218

 

2,913,938

 

20,547,070

 

2,586,477