Form 8-K - Current report

0001527096false00015270962023-08-142023-08-14

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 14, 2023

Miromatrix Medical Inc.

(Exact name of registrant as specified in its charter)

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Delaware	001-40518	27-1285782
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification Number)

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6455 Flying Cloud Drive, Suite 107

Eden Prairie, MN 55344

(Address of principal executive offices, including zip code)

[phone]

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered or to be registered pursuant to Section 12(b) of the Act:

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Title of each class	Trading symbol	Name of each exchange on which registered
Common stock, $0.00001 par value per share	MIRO	The Nasdaq Stock Market LLC

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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​	Emerging growth company   ☒

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

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Item 2.02Results of Operations and Financial Condition.

On August 14, 2023, Miromatrix Medical Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this current report on Form 8-K.

The information contained in Item 2.02 and Exhibit 99.1 is being furnished, and shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under Section 18. Furthermore, the information contained in Item 2.02 and Exhibit 99.1 shall not be deemed to be incorporated by reference into the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01Financial Statements and Exhibits.

(d)	Exhibits.
Exhibit No.	Description
99.1	Press Release, dated August 14, 2023
104	Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: August 14, 2023	Miromatrix Medical Inc.
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​	By:	/s/ James Douglas
​	​	James Douglas
​	​	Chief Financial Officer

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Exhibit 99.1

Miromatrix Reports Second Quarter 2023 Results and Provides Corporate Update

EDEN PRAIRIE, MN, August 14, 2023 - 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 2023 financial results and provided a corporate update.

"Miromatrix remains on pace to submit a response to the FDA’s clinical hold letter relating to our miroliverELAP^tm IND application in the second half of 2023," said Jeff Ross, Ph.D., Miromatrix CEO. "We continue to progress towards our goal of gaining authorization from the FDA to initiate a Phase 1 clinical trial to treat patients suffering from acute liver failure and becoming the first company to treat patients with bioengineered organs."  

Business Highlights and Corporate Update

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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

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Nearing completion of in-life portion of animal safety study and biocompatibility study to address issues identified in the miroliverELAP clinical hold letter

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Presented three posters at 2023 American Transplant Congress ("ATC") and was awarded Best in Congress for a mirokidneytm poster

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Participated in National Kidney Foundation's ("NKF") Innovation Day congressional event

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Participated in Association of Organ Procurement Organizations ("AOPO") annual meeting panel titled Saving Lives Through Telepathology and Bioengineering

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Represented cell & gene therapy sector to Capitol Hill policy makers at Alliance for Regenerative Medicine("ARM")  Congressional Fly-In

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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

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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 $20.4 million as of June 30, 2023, compared to $25.6 million as of March 31, 2023.  Additionally, received cash payments for $457,143 of the $527,143 employee

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retention credit receivable subsequent to the second quarter and remaining amount has been confirmed for upcoming receipt by the Internal Revenue Service.  

Operating loss was $6.7 million and $14.8 million for the three- and six-month periods ended June 30, 2023, respectively, as compared to $8.2 million and $15.4 million for the three- and six- month periods ended June 30, 2022, respectively. The decrease in operating loss for comparable periods was primarily attributable to reduced research and development lab supply costs.

Net loss was $6.5 million and $14.0 million for the three- and six-month periods ended June 30, 2023, respectively, as compared to $8.2 million and $15.4 million for the three- and six- month periods ended June 30, 2022, respectively. The decrease in net loss for comparable periods was primarily attributable to reduced research and development lab supply costs, in addition to a one-time employee retention credit totalling $0.5 million that was recorded as other income in the first quarter of 2023.

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 14, 2023, at 4:30 PM ET.

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

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," "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

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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.

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Investor Contact

Greg Chodaczek

347-620-7010

[e-mail]

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Media Contact:

Christina Campbell

612-924-3793

[e-mail]

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MIROMATRIX MEDICAL INC.

Condensed Balance Sheets

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​	​	​	​	​	​	​
​	​	June 30,		​	December 31,
​		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 Reprise Biomedical, Inc.		​	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
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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 $0.00001; 190,000,000 shares authorized; 27,310,553 issued and outstanding as of June 30, 2023 and 20,944,109 issued and outstanding as of December 31, 2022	​		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

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MIROMATRIX MEDICAL INC.

Condensed Statements of Operations

(Unaudited)

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Three Months Ended

Six Months Ended

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June 30,

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June 30,

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2023

2022

2023

2022

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Licensing revenue

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$

8,517

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$

3,952

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$

16,498

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$

10,720

Cost of goods sold

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125,000

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125,000

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250,000

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250,000

Gross loss

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(116,483)

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(121,048)

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(233,502)

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(239,280)

Operating expenses:

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Research and development

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3,621,224

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4,988,233

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8,013,342

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8,994,899

Regulatory and clinical

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397,448

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419,394

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803,763

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774,632

Quality

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515,575

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517,333

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1,098,917

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958,268

General and administration

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2,037,682

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2,188,460

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4,637,917

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4,461,017

Total operating expenses

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6,571,929

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8,113,420

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14,553,939

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15,188,816

Operating loss

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(6,688,412)

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(8,234,468)

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(14,787,441)

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(15,428,096)

Other income (expense)

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Interest income

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166,162

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61,078

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268,139

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61,848

Interest expense

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(8,170)

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(8,799)

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(18,413)

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(19,690)

Employee retention credit

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—

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—

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527,143

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—

Total other income

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157,992

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52,279

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​

776,869

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​

42,158

Net loss

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$

(6,530,420)

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$

(8,182,189)

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$

(14,010,572)

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$

(15,385,938)

Net loss per share, basic and diluted

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$

(0.24)

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$

(0.40)

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$

(0.56)

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$

(0.75)

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

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27,250,573

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20,615,218

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24,897,796

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20,547,070

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Document and Entity Information	Aug. 14, 2023
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	Aug. 14, 2023
Entity Registrant Name	Miromatrix Medical Inc.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-40518
Entity Tax Identification Number	27-1285782
Entity Address, Address Line One	6455 Flying Cloud Drive, Suite 107
Entity Address, City or Town	Eden Prairie
Entity Address State Or Province	MN
Entity Address, Postal Zip Code	55344
City Area Code	952
Local Phone Number	942-6000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.00001 par value per share
Trading Symbol	MIRO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Central Index Key	0001527096
Amendment Flag	false

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