Form 8-K - Current report

 

  

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): October 21, 2024

 

Elevai Labs Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-41875		85-1399981
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

c/o 120 Newport Center Drive, Ste. 250 Newport Beach, CA		92660
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: [phone]

 

N/A

(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 240.13©(c))

 

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

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value		ELAB		The Nasdaq Stock Market LLC

 

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 8.01 Other Events

 

On October 21, 2024, Elevai Biosciences Inc. (“Elevai Biosciences”), a subsidiary of Elevai Labs Inc. (the “Company”), released what the Company believes to be encouraging past preclinical data from 2022 for EL-32, a pioneering dual-action blocker targeting myostatin and activin-A. Preclinical results generated from the Company’s licensing partner in a 2022 study (“Efficacy Study of New Drug Candidate for Sarcopenia,” such entitled study the “Clinical Study”) indicated that EL-32 may offer a breakthrough approach to obesity treatment by simultaneously preserving muscle mass and reducing fat mass when used alongside popular weight loss therapies such as GLP-1 receptor agonists.

 

EL-32, an engineered probiotic expressing dual myostatin & activin-A, targets two clinically validated targets that play an important role in regulating muscle. In 15-week preclinical studies on aged C57BL/6J mice, EL-32 administration resulted in statistically significant improvements across key measures of physical muscular function and body composition. Highlights from the results of these studies include:

 

●

Enhanced grip strength, with notable, statistically significant increases observed at week 15.

●

Improved motor performance, evidenced by longer, statistically significant rotarod latency durations.

●

Optimized body composition, demonstrated by DEXA scans.

 

Based on this preclinical data, the Company believes that EL-32 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. The Company anticipates that full preclinical data is expected to be shared at a future scientific conference.

 

The above is a summary of the preclinical data and is qualified in its entirety by reference to the results of the Clinical Study filed to this Current Report on Form 8-K (this “Report”) as Exhibit 99.1. The Company’s press release regarding the aforementioned preclinical results, issued on October 21, 2024, and which contains more information regarding the aforementioned preclinical data, is filed to this Report as Exhibit 99.2.

 

Forward Looking Statements

 

This Report, including Exhibits 99.1 and 99.2 hereto, contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should” or similar expressions, although some forward-looking statements are expressed differently. Forward-looking statements represent the Company’s management’s judgment regarding future events. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. All statements other than statements of historical fact included in the Current Report on Form 8-K are forward-looking statements. The Company cannot guarantee the accuracy of the forward-looking statements, and you should be aware that the Company’s actual results could differ materially from those contained in the forward-looking statements due to a number of factors, including the statements under “Risk Factors” contained in the Company’s reports filed with the SEC.

 

 

 

 

Item 9.01 Financial Statements and Exhibits. 

 

(d) Exhibits. 

 

The following exhibits are being filed herewith: 

 

Exhibit No.		Description
99.1		Results of Efficacy Study of New Drug Candidate for Sarcopenia
99.2		Press Release dated October 21, 2024
104		Cover Page Interactive Data File (embedded with the Inline XBRL document).

 

*	Furnished herewith.

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: October 24, 2024

 

Elevai Labs, Inc.
By:	/s/ Graydon Bensler
Name:	Graydon Bensler
Title:	Chief Executive Officer, President and Director

 

 

 

2

Exhibit 99.1

 

KNOTUS Co., Ltd. STUDY No. 21 - KE - 1021 Efficacy study of new drug candidate for sarcopenia

 

 

Experiment protocol 1. Experiment group 2. Experiment schedule group sex Administration Amount r o u te (mL/head) material (n)

 

 

Ex perimen t resul ts 1. Body weight 2. Muscle weight There was no tendency to increase weight and muscle weight by administration of test material.

 

 

Ex perimen t resul ts 3 . Gr i p s t rength At week 7, G3 was significantly higher compared to that of G1 (p<0.01), and at weeks 13 and 15, the grip strength level of G2 and G3 were significantly higher than that of G1 (p<0.01, or p<0.05).

 

 

Ex perimen t resul ts 4. Rota - rod latency At 15 weeks, it was confirmed that the latency level of G3 was significantly higher than that of G1 (p<0.01).

 

 

Ex perimen t resul ts 5 . D X A a n a l ys i s The length level of G 3 and G 4 were significantly higher than G 1 (p< 0 . 01 or p< 0 . 05 ), and the total weight (FL) level of G 2 was significantly higher than that of G 1 (p< 0 . 05 ), and it was confirmed that the length level of G 3 , G 4 , and G 5 were significantly higher than that of G 1 .

 

 

Ex perimen t resul ts 6. CSA analysis In EDL (extensor digitorum longus), CSA levels of G5 were significantly higher compared to G1.

 

Exhibit 99.2

 

IMMEDIATE RELEASE

 

Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Highlights Past Positive Preclinical Data Showing Potential of EL-32, A Dual Myostatin & Activin-A Blocker, For The Treatment of Obesity

 

●

Preclinical results of EL-32 demonstrated statistically significant increases in grip strength, motor function and body composition in aged C57BL/6J mouse model.

 

●

Elevai believes that EL-32 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.

 

●

Elevai plans to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application.

 

NEWPORT BEACH, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) Elevai Biosciences Inc. (“Elevai Biosciences”), a subsidiary of Elevai Labs Inc. (NASDAQ: ELAB) (“Elevai” or the “Company”), today released encouraging past preclinical data from 2022 for EL-32, a pioneering dual-action blocker targeting myostatin and activin-A. Preclinical results generated from our licensing partner in a 2022 study indicate that EL-32 may offer a breakthrough approach to obesity treatment by simultaneously preserving muscle mass and reducing fat mass when used alongside popular weight loss therapies such as GLP-1 receptor agonists..

 

EL-32, an engineered probiotic expressing dual myostatin & activin-A, targets two clinically validated targets that play an important role in regulating muscle. In 15-week preclinical studies on aged C57BL/6J mice, EL-32 administration resulted in statistically significant improvements across key measures of physical muscular function and body composition. Highlights from the results of these studies include:

 

●

Enhanced grip strength, with notable, statistically significant increases observed at week 15.

 

●

Improved motor performance, evidenced by longer, statistically significant rotarod latency durations.

 

●

Optimized body composition, demonstrated by DEXA scans.

 

“Popular GLP-1 medications like Ozempic and Mounjaro are faced with associated loss of muscle,” said Deniel Mero, Co-founder of Elevai Biosciences. Mero stated, “Myostatin and activin-A are two validated targets that have demonstrated potential in muscle mass, strength building, and are also being tested in clinical trials with GLP-1 medications. These validated pathways, literature and the preclinical data generated to date, gives us reasons to believe that EL-32 has the potential to treat obesity while preserving muscle.”

 

Based on the highlighted preclinical data from our licensing partner, Elevai believes that EL-32 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application. Full preclinical data is expected to be shared at a future scientific conference.

 

 

 

 

About Elevai Labs, Inc.

 

Elevai specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to obesity and metabolic health. The Company operates a diverse portfolio of three wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors, Elevai Skincare Inc., Elevai Biosciences Inc., and Elevai Research Inc. For more information please visit www.elevailabs.com.

 

About Elevai Biosciences

 

Elevai Biosciences, a subsidiary of Elevai, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Elevai Biosciences’ lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.elevaibio.com.

 

Forward-Looking Statements

 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results. Therefore, you should not rely on any of these forward-looking statements. These and other risks are described more fully in Elevai’s filings with the U.S. Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

IR Contact:

[e-mail]

 

 

 

 

Cover	Oct. 21, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 21, 2024
Entity File Number	001-41875
Entity Registrant Name	Elevai Labs Inc.
Entity Central Index Key	0001840563
Entity Tax Identification Number	85-1399981
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	c/o 120 Newport Center Drive
Entity Address, Address Line Two	Ste. 250
Entity Address, City or Town	Newport Beach
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92660
City Area Code	866
Local Phone Number	794-4940
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	ELAB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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