# EDGAR Filing Document

**Accession Number:** 0001721484
**File Stem:** 0001213900-23-001264
**Filing Date:** 2023-1
**Character Count:** 13976
**Document Hash:** 0e0a644db1fb59e36e6984629857e233
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-001264.hdr.sgml**: 20230106

**ACCESSION NUMBER**: 0001213900-23-001264

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230106

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230106

**DATE AS OF CHANGE**: 20230106

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Longeveron Inc.
- **CENTRAL INDEX KEY:** 0001721484
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 472174146
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40060
- **FILM NUMBER:** 23514181

**BUSINESS ADDRESS:**
- **STREET 1:** 1951 NW 7TH AVENUE
- **STREET 2:** SUITE 520
- **CITY:** MIAMI
- **STATE:** FL
- **ZIP:** 33136
- **BUSINESS PHONE:** 305-302-7158

**MAIL ADDRESS:**
- **STREET 1:** 1951 NW 7TH AVENUE
- **STREET 2:** SUITE 520
- **CITY:** MIAMI
- **STATE:** FL
- **ZIP:** 33136

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** LONGEVERON LLC
- **DATE OF NAME CHANGE:** 20171101

?xml version="1.0" encoding="utf-8"?

**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): January 6, 2023**

**Longeveron Inc.**

**(Exact name of registrant as specified in its charter)** 

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-40060** | **47-2174146** |
| **(State or Other Jurisdiction<br> of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br> Identification No.)** |

---

**1951 NW 7<sup>th</sup> Avenue** **, Suite 520**, **Miami** **, Florida 33136**

**(Address of Principal Executive Offices)** 

**Registrant's Telephone Number, Including Area Code: (305) 909-0840** 

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 pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange**<br> **on which registered** |
| **Class A Common Stock, $0.001 par value per share** | **LGVN** | **NASDAQ** |

---

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)

Emerging Growth Company ☒

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. ☐

**Item 7.01 Regulation FD Disclosure.**

On January 6, 2023, Longeveron Inc. (the "Company") issued a press release providing a corporate update regarding the Company's strategic priorities and anticipated milestones for 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

The information presented in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 is being furnished and shall not be deemed filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise be subject to the liabilities of that section, nor is it incorporated by reference into any filing of the Company, under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Item 9.01. Financial Statements and Exhibits.**

 

*(d)* *Exhibits* 

 

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release dated January 6, 2023](ea171341ex99-1_longeveron.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |

---

**SIGNATURE** 

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.

---

| | | |
|:---|:---|:---|
|  | **LONGEVERON INC.** | **LONGEVERON INC.** |
| Date: January 6, 2023 | /s/ James Clavijo | /s/ James Clavijo |
|  | Name: | James Clavijo |
|  | Title: | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Longeveron Provides Corporate Update and Announces 2023 Strategic Priorities and Anticipated Milestones**

 

*– Expects to enroll first patient in Phase 2* 

*clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan in 1Q23 –*

 

*– Extended cash runway into 2H24 –*

**Miami, Florida – January 6, 2023—** Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today provided a corporate update highlighting the Company's strategic priorities and anticipated milestones for 2023.

"This past year Longeveron made robust progress advancing our lead investigational product Lomecel-B<sup>TM</sup> in multiple indications, achieving key regulatory and clinical development milestones across our programs," said Chris Min, M.D., Ph.D., Longeveron's Interim Chief Executive Officer and Chief Medical Officer. "In the first quarter, we look forward to enrolling the first patient in our Phase 2 Aging-Related Frailty trial in Japan, where we believe we are in a strong position to help deliver a much-needed therapy to the country's aging population. In 2023, we will focus our Aging-Related Frailty efforts in Japan, while continuing to build on our progress in HLHS and Alzheimer's Disease. Additionally, we have extended our cash runway into the second half of 2024, placing us in a strong position to execute on our corporate objectives."

**2023 Pipeline Updates and Anticipated Milestones** 

&nbsp;&nbsp;&nbsp;&nbsp;· **Hypoplastic Left Heart Syndrome (HLHS):** The ELPIS II trial continues to enroll at 7 clinical sites.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o ELPIS II is a Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial
injection of Lomecel-B<sup>TM</sup> in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Lomecel-B<sup>TM</sup> for HLHS has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations
from the U.S. Food and Drug Administration (FDA). Longeveron expects to publish the full data from the Phase 1 ELPIS I trial in a peer-reviewed
publication in 1Q23. Top-line data from ELPIS I were previously announced in 2021.

&nbsp;&nbsp;&nbsp;&nbsp;· **Aging-Related Frailty:** Longeveron expects to enroll the first patient in the Company's Phase
2 clinical trial of Lomecel-B<sup>TM</sup> for Aging-Related Frailty in Japan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind
single-infusion study of two different dose levels of Lomecel- B<sup>TM</sup>. The primary objective of the study is to evaluate the safety
of Lomecel-B<sup>TM</sup> as a treatment for Aging-Related Frailty. The trial is expected to enroll 45 patients. The Phase 2 trial is
being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG; Nagoya) and Juntendo University Hospital
(Tokyo) and the clinical sites have been activated and patients are being screened for participation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o After consultation with the United States Food and Drug Administration (FDA), Longeveron may advance a
parallel program in the United States. In the near-term, Longeveron is focusing its Aging-Related Frailty resources on clinical development
in Japan.

&nbsp;&nbsp;&nbsp;&nbsp;· **Alzheimer's Disease:** In November 2022, Longeveron announced the completion of enrollment in a Phase 2a trial of Lomecel-B<sup>TM</sup>
in patients with mild Alzheimer's Disease (AD). Longeveron expects to release topline data from the Phase 2a trial in early 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o The Phase 2a trial is a clinical trial of Lomecel-B<sup>TM</sup> designed to evaluate the safety of single and multiple infusions
of two different dose levels compared to placebo in patients with mild AD.

**Financial Guidance**

&nbsp;&nbsp;&nbsp;&nbsp;· Longeveron ended 2022 with approximately $20 million in cash, cash equivalents and investments, which the Company believes is sufficient
to fund its anticipated expenses and capital expenditure requirements into the second half of 2024.

**About Longeveron Inc.**

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple mechanisms of action encompassing pro-vascular, pro-regenerative, and anti-inflammatory, promoting tissue repair and healing with broad potential applications across a spectrum of disease areas. Longeveron is advancing Lomecel-B™ through clinical trials in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease, and Aging-Related Frailty. Additional information about the Company is available at www.longeveron.com.

**Cautionary Note Regarding Forward-Looking Statements**

Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron's clinical trials to demonstrate safety and efficacy of the Company's product candidates, and other positive results; the timing and focus of the Company's ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company's product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company's product candidates; the Company's ability to obtain and maintain regulatory approval of its product candidates; the Company's plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan and other jurisdictions; the Company's plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company's ability to attract and retain such personnel; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company's financial performance, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditures requirements. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the Securities and Exchange Commission, including Longeveron's Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

**Investor Contact:**

Stern IR, Inc.

212-698-8700

longeveron@sternir.com

Source: Longeveron Inc