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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): March
4, 2025
SAFETY
SHOT, INC.
(Exact
name of registrant as specified in charter)
Delaware |
|
001-39569 |
|
83-2455880 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
1061
E. Indiantown Rd., Ste. 110, Jupiter, FL 33477
(Address
of principal executive offices) (Zip Code)
(561)
244-7100
(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 (see General Instruction A.2. below):
☐ |
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 on which registered |
Common
Stock |
|
SHOT |
|
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market) |
|
|
|
|
|
Warrants,
each exercisable for one share of Common Stock at $8.50 per share |
|
SHOTW |
|
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market) |
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 mart 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
March 4, 2025, Safety Shot, Inc. (the “Company”) issued a press release. A copy of the press release is furnished hereto
as Exhibit 99.1 and incorporated herein by reference.
Exhibits
9.01 Financial Statements and Exhibits
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.
Date:
March 4, 2025
SAFETY
SHOT, INC. |
|
|
|
By: |
/s/
Jarrett Boon |
|
|
Jarrett
Boon, |
|
|
Chief
Executive Officer |
|
Exhibit 99.1
FOR
IMMEDIATE RELEASE
Safety
Shot Announces First Peer-Reviewed Publication of Human Clinical Trial Confirming Rapid Alcohol Reduction and Hangover Prevention
New
controlled study published in Journal of Nutrition and Dietary Supplements highlights statistically significant reductions in
ethanol levels following acute alcohol intake
SCOTTSDALE,
Ariz., March 4, 2025 – Safety Shot, Inc. (Nasdaq: SHOT) (“Safety Shot” or the “Company”), a wellness
and dietary supplement company, today announces the peer-reviewed publication of its groundbreaking randomized, double-blind, placebo-controlled
clinical trial evaluating the efficacy of Safety Shot® in mitigating the negative effects of alcohol consumption. The study, published
in the Journal of Nutrition and Dietary Supplements (Feb 26, 2025, Volume 17, Pages 43-62), demonstrates that Safety Shot®
statistically significantly reduces blood alcohol concentration (BAC), breath alcohol concentration (BrAC), and hangover symptoms compared
to placebo (p < 0.05), and at a remarkably faster rate than the body’s natural processes. For the complete article, visit
the website at: https://doi.org/10.2147/NDS.S507571
“This
is a momentous occasion for Safety Shot as it demonstrates in a peer-reviewed setting, the potential for the product’s utility
in daily practice. Alcohol consumption may have implications in multiple settings, but the results of this study show that there are
solutions available – over the counter – that can mitigate its effects and dangers and allow for a more positive overall
experience,” said Jarrett Boon, Safety Shot CEO. “Our unwavering commitment to scientific research and development has culminated
in this groundbreaking achievement, and we believe that this clinically proven solution empowers individuals to take responsibility and
control of their alcohol consumption.”
This
is the first-ever human clinical trial to demonstrate the efficacy of a dietary supplement blend in reducing the acute effects
of alcohol. Previous research has primarily relied on animal models, which may not translate directly into human physiology. Safety Shot’s
human clinical trial provides more relevant and reliable data, positioning Safety Shot® as a revolutionary advancement in the field
and a potential game-changer for the growing market of individuals seeking to manage the after-effects of alcohol consumption.
Details
of the Trial
The
study, conducted by The Center for Applied Health Sciences (CAHS), an independent, third-party research organization, involved
healthy men and women of various ages, ethnicities and body types. Participants were randomly assigned to consume alcohol followed by
either Safety Shot® or a placebo in a crossover design, where each participant served as their own control. This rigorous double-blind,
randomized, placebo-controlled, crossover design ensured the highest level of scientific rigor and minimized inter-individual variability.
Details include:
| ● | Rapid
Alcohol Reduction: Safety Shot® reduced blood alcohol levels in as little as 30
minutes. This was evidenced by statistically significant reductions (p< 0.05) in
both blood-drawn and breath-analyzed alcohol levels at 30 through 240 minutes after consumption. |
| ● | Rapid
and Substantial Increase in Aldehyde Dehydrogenase: Over time, the aldehyde dehydrogenase
values were significantly heightened. The AUC and Cmax for aldehyde dehydrogenase were both
significantly greater in Safety
Shot® vs Placebo (p = 0.004 and p = 0.010 respectively),
suggesting an altering of the kinetics of acetaldehyde. By temporarily elevating acetaldehyde,
Safety Shot effectively triggered a faster metabolic response, enhancing the body’s
ability to eliminate alcohol and its toxic intermediates. |
| | |
| ● | Improved
Hangover Symptoms: Trial participants taking Safety Shot® reported less head discomfort,
reduced fatigue, increased energy levels, improvements in concentration, and reduced feelings
of tiredness compared to the placebo. These improvements were observed at multiple time points
throughout the study, as evidenced by the VAS scores. |
| | |
| ● | Increased
Urine Output: Participants in the Safety Shot® group had greater urine output, particularly
at the 60-minute mark, suggesting enhanced elimination of alcohol from the body. |
Dr.
Tim Ziegenfuss, CEO of CAHS, added, “These results are highly encouraging, showcasing Safety Shot’s potential as a beneficial
supplement for individuals consuming alcohol. The observed reductions in breath and blood alcohol levels, along with the improvements
in subjective feelings and physiological measures, highlight the benefit of Safety Shot in supporting better outcomes in post-alcohol
consumption.”
The
Company notes that given ethical and legal limitations, participants were only permitted to consume a small amount of alcohol. Further,
study protocol was not limited to specific demographics as defined by age (except to be able to legally consume alcohol), sex, anthropometric
disposition or frequency and tolerance of alcohol consumption. While many studies attempt to control for these variables, investigators
made this as broad as possible to verify the potential for the widest use, and success, possible.
With
these groundbreaking results, Safety Shot® is entering a massive and rapidly expanding global market for hangover cure products.
According to a report by Grand View Research, this market is projected to grow at a compound annual growth rate (CAGR) of 14.1% from
2023 to 2030, reaching over $6 billion by 2032. This growth is fueled by increasing alcohol consumption, rising awareness of the negative
health consequences of hangovers, and a growing desire for effective solutions. Safety Shot®, with its clinically proven efficacy
and unique human-based research, is strategically positioned to capture a significant share of this burgeoning market.
About
Safety Shot, Inc.
Safety
Shot, Inc., a wellness and dietary supplement company, has developed Sure Shot, the first patented wellness product on Earth that lowers
blood alcohol content by supporting its metabolism, while boosting clarity, energy, and overall mood. Sure Shot is available for purchase
online at www.sureshot.com, www.walmart.com and Amazon. Safety Shot, Inc. is introducing business-to-business sales of
Sure Shot to distributors, retailers, restaurants, and bars throughout 2025. Safety Shot® is a proprietary blend of natural ingredients,
including red ginseng, N-acetyl cysteine, dandelion extract, milk thistle, and other antioxidants, anti-inflammatory agents, and nootropics.
These ingredients work synergistically to support the body’s natural detoxification processes, reduce oxidative stress, and promote
overall wellness.
Investor
Relations:
CORE
IR
516
222 2560
investors@drinksafetyshot.com
Media
Contact:
CORE
IR
Jules
Abraham
516
222 2560
julesa@coreir.com
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