8-K - BFRG - Equibles

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): September 26, 2023

BULLFROG

AI HOLDINGS, INC.

(Exact name of registrant as specified in charter)

Nevada	001-41600	84-4786155
(State<br> or other jurisdiction	(Commission	(IRS<br> Employer
of<br> incorporation)	File<br> Number)	Identification<br> No.)

325Ellington Blvd, Unit 317

Gaithersburg,MD 20878

(Address of principal executive offices) (Zip Code)

(240)658-6710

(Registrant’s telephone number, including area code)

NotApplicable

(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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> 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<br> Stock, par value $ 0.00001 per share	BFRG	The<br> Nasdaq Stock Market LLC <br><br>(The Nasdaq Capital Market)
Tradeable<br> Warrants	BFRGW	The<br> Nasdaq Stock Market LLC <br><br>(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 ☒

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. ☐

Item7.01 Regulation FD Disclosure

On September 26, 2023, Bullfrog AI Holdings, Inc. issued a press release. A copy of the press release is attached hereto and incorporated herein by reference in its entirety as Exhibit 99.1. The Company also is disclosing certain data to investors in connection with its discussion of its recent preclinical study which is the subject of the press release attached as Exhibit 99.1. The data in Exhibit 99.2 is attached hereto and incorporated herein by reference in its entirety as Exhibit 99.2.

Item9.01 Financial statements and Exhibits

(d) Exhibits.

Exhibit Number	Description
Exhibit<br> 99.1	Press Release dated September 26, 2023
Exhibit<br> 99.2	Investor Presentation Materials
104	Cover<br> Page Interactive Data File (embedded within the Inline XBRL document)

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: September 26, 2023

BULLFROG AI HOLDINGS, INC.
By:	/s/ Vininder Singh
	Vininder<br> Singh
	Chief<br> Executive Officer

Exhibit99.1

Healthcare Investor Relations | Corporate Communications | Clinical Trial Patient Recruitment

BullFrogAI Announces Positive Data from Preclinical Study Evaluating Novel Prodrug of Mebendazole for Treatment ofGlioblastoma

BullFrogAI’s patented drug BF-223 Demonstrates Anti-Cancer Activity Against Glioblastoma in Established Animal Model

Gaithersburg, MD – September 26, 2023 – BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) (“BullFrog AI” or the “Company”), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced positive data in a preclinical study investigating the anti-cancer activity of a novel prodrug of mebendazole for the treatment of glioblastoma. The study assessed the relative efficacy of BF-222, a novel formulation of mebendazole that has been evaluated in clinical trials, and BF-223, a novel prodrug of mebendazole with improved solubility and bioavailability relative to BF-222, compared with placebo in mice that had been implanted with tumor cells as a model for human glioblastoma.

Animals treated with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given placebo. Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for both treatment groups were statistically significant compared to placebo. In addition, animals treated with equivalent doses of BF-222 and BF-223 showed comparable and significant reduction in tumor growth compared to control animals during the study.

“This is the first study to demonstrate that BF-223, a novel mebendazole prodrug, has anti-cancer activity in animals,” said Vin Singh, Chairman and CEO of BullFrog AI. “The data from this study, combined with BF-223’s improved properties, gives us confidence that BF-223 has potential to be an effective treatment in the fight against glioblastoma, a form of cancer for which there are few good treatment options. We are currently pursuing partnering opportunities for BF-222 and BF-223 with pharmaceutical companies and are confident that these data will assist in that effort.”

AboutGlioblastoma

Glioblastoma is a fast-growing and aggressive type of cancer that occurs in the brain or spinal cord. It is the most common malignant tumor of the central nervous system (CNS), accounting for nearly 50% of primary malignant tumors occurring in the CNS. Treatment options include surgery, radiation and chemotherapy with the drug temozolomide, but the prognosis for survival in patients diagnosed with glioblastoma remains poor, with a five-year survival rate of less than 10%. The global glioblastoma multiforme treatment market is projected to increase from $ 5.1 billion in 2020 to an estimated $ 10.2 billion by 2030, growing at a compound annual growth rate of 12.8% during the forecast period, according to a report by Vision Research Reports.

35 W. 35^th^ Street, 11^th^ Floor | New York, NY 10001 | 212 827 0020 | www.tiberend.com

Healthcare Investor Relations | Corporate Communications | Clinical Trial Patient Recruitment

AboutBullFrog AI

BullFrog AI is a technology-enabled drug development company that creates and analyzes networks of biological, clinical, and real-world data spanning from early discovery to late-stage clinical trials. Through its partnerships with leading research institutions, BullFrog AI is at the forefront of AI-driven drug development using its proprietary bfLEAP™ artificial intelligence platform. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics.

For more information visit BullFrog AI at

Website: https://bullfrogai.com

LinkedIn: https://www.linkedin.com/company/bullfrogai/

SafeHarbor Statement

This press release contains forward-looking statements. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.

BFRGContacts:

Investors

Dave Gentry

RedChip Companies, Inc.

BFRG@redchip.com

800-733-2447

Media

Tiberend Strategic Advisors, Inc.

Eric Reiss

ereiss@tiberend.com

802-249-1136

Dave Schemelia

dschemelia@tiberend.com

609-468-9325

**SOURCE:**BullFrog AI Holdings, Inc.

35 W. 35^th^ Street, 11^th^ Floor | New York, NY 10001 | 212 827 0020 | www.tiberend.com

Exhibit 99.2