Current Report Filing (8-k)
August 13 2021 - 1:47PM
Edgar (US Regulatory)
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
13, 2021
Commission File No. 001-40060
Longeveron Inc.
(Exact name of small business issuer as specified
in its charter)
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Delaware
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47-2174146
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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1951 NW 7th Avenue, Suite 520
Miami, Florida
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33136
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(Address of principal executive offices)
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(Zip Code)
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(305) 909-0840
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(Issuer’s telephone number, including area code)
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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 (see General
Instruction A.2. below):
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b)
of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Class A Common Stock, par value $.001 per share
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LGVN
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The Nasdaq Capital Market
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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).
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. ☐
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Item 7.01.
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Regulation FD.
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On August 13, 2021, Longeveron Inc. (the “Company”)
announced results from the Company’s Phase 2b trial titled: A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate
the Safety and Efficacy of Lomcecel-B Infusion in Patients With Aging Frailty (the “Phase 2b trial”). Lomecel-B is a proprietary
allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors, culture-expanded in Longeveron’s
current good manufacturing practice (cGMP) cell processing facility. The Phase 2b trial, which was partially funded by a Small Business
Innovation Research (SBIR) grant from the National Institute on Aging (NIA), evaluated the safety and efficacy of a single peripheral
intravenous infusion of four different doses of Lomecel-B cell therapy (25 million (n=37), 50 million (n=31), 100 million (n=34) and 200
million (n=16) cells; sample size reflects any subject that was randomized and received an infusion) compared to placebo (n=30), on signs
and symptoms of Aging Frailty, including mobility and exercise tolerance.
The pre-specified statistical analysis plan for
the primary efficacy endpoint, change in six-minute walk test distance at 180 days post-infusion, involved a primary analysis and a secondary
analysis as follows:
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Primary analysis of the primary efficacy endpoint: The primary
analysis compared the change from baseline in 6MWT distance for the four Lomecel-B cohorts to the placebo cohort at Day 180. There were
statistically significant increases in the highest 3 doses--50 million, 100 million and 200 million Lomecel-B cohorts--and no significant
changes in the placebo or lowest dose of Lomecel-B (25 million=7.8 meters, p=0.5040; 50 million=35.8 meters, p=0.0053; 100 million=24.9
meters p=0.0443; 200 million=49.3 meters, p=0.0065; placebo=8.0 meters, p=0.5371). However, after adjusting for multiple comparisons
using the Hochberg method (1988), the four Lomecel-B cohorts did not show a statistically significant placebo-adjusted difference (Δ)
(25 million Δ=-0.2, p=0.9902; 50 million Δ=27.7, p=0.1279; 100 million Δ=16.8, p=0.3472; 200 million Δ=41.3,
p=0.0635).
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Secondary analysis of the primary efficacy endpoint: The secondary
analysis was to determine whether a dose-response relationship exists using the multiple comparisons and modeling approach by Bretz et.
al (2003). The results showed a clear, statistically significant dose-response curve at day 180. Among the various dose-response curves
evaluated (Emax, Linear, Exponential, Quadratic, and Sigmoid Emax), all had p-values of less than 0.05, with the Sigmoid Emax model having
the most significant dose-response relationship (p=0.0170).
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Despite not achieving the statistical significance
for the pairwise comparison to placebo at Day 180, significant differences from placebo were observed at Day 270, which was a pre-specified
exploratory endpoint (25 million Δ=27.5, p=0.1530; 50 million Δ=49.2, p=0.0122; 100 million Δ=31.0, p=0.1071; 200 million
Δ=63.4, p=0.0077).
The full text of the press release issued in connection
with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Also, attached as Exhibit 99.2 is a Company slide
displaying the MCP-MOD for Change from Baseline in 6 Minute Walk Test (6MWT) Distance (m) at Day 180 Dose-Response Curve from the Best-Fitted
Model (Modified intent-to-treat population). This slide was presented during the Company’s earnings call held today, on August 13,
2021,
The information provided under this Form 8-K (including
Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the
“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in
such a filing.
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Item 9.01.
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Financial Statements and Exhibits.
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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.
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August 13, 2021
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Longeveron Inc.
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By:
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/s/ Geoff Green
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Geoff Green
Chief Executive Officer
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(Principal Executive Officer)
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Exhibit Index
3
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