0001558370-24-008779.txt : 20240530 0001558370-24-008779.hdr.sgml : 20240530 20240530161023 ACCESSION NUMBER: 0001558370-24-008779 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 20240523 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240530 DATE AS OF CHANGE: 20240530 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIO-PATH HOLDINGS, INC. CENTRAL INDEX KEY: 0001133818 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 870652870 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36333 FILM NUMBER: 241005470 BUSINESS ADDRESS: STREET 1: 4710 BELLAIRE BOULEVARD STREET 2: SUITE 210 CITY: BELLAIRE STATE: TX ZIP: 77401 BUSINESS PHONE: (832) 742-1357 MAIL ADDRESS: STREET 1: 4710 BELLAIRE BOULEVARD STREET 2: SUITE 210 CITY: BELLAIRE STATE: TX ZIP: 77401 FORMER COMPANY: FORMER CONFORMED NAME: BIO-PATH HOLDINGS INC DATE OF NAME CHANGE: 20080221 FORMER COMPANY: FORMER CONFORMED NAME: OGDEN GOLF CO CORP DATE OF NAME CHANGE: 20010205 8-K 1 bpth-20240523x8k.htm 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): May 23, 2024

BIO-PATH HOLDINGS, INC.

(Exact name of registrant as specified in its charter)


Delaware	001-36333	87-0652870
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)


4710 Bellaire Boulevard, Suite 210, Bellaire, Texas		77401
(Address of principal executive offices)		(Zip Code)

(832) 742-1357

(Registrant’s Telephone Number, Including Area Code)

(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 240.13e-4(c))

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


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	BPTH	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 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 May 23, 2024, Bio-Path Holdings, Inc. (the “Company”) issued a press release titled, “Bio-Path Holdings to Present Data at American Society of Clinical Oncology (ASCO) Annual Meeting.” A copy of such press release is attached hereto as Exhibit 99.1.

On May 24, 2024, the Company issued a press release titled, “Bio-Path Holdings to Present Data at 2024 European Hematology Association Congress.” A copy of such press release is attached hereto as Exhibit 99.2.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


Exhibit
Number		Description

99.1		Press release dated May 23, 2024.
99.2		Press release dated May 24, 2024.
104		The cover page from this Current Report on Form 8-K, formatted in Inline XBRL (included as Exhibit 101).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this Current Report to be signed on its behalf by the undersigned hereunto duly authorized.


	BIO-PATH HOLDINGS, INC.


Dated: May 30, 2024	By:	/s/ Peter H. Nielsen
		Peter H. Nielsen
		President and Chief Executive Officer

EX-99.1 2 bpth-20240523xex99d1.htm EX-99.1

Exhibit 99.1

Bio-Path Holdings to Present Data at American Society of Clinical Oncology (ASCO) Annual Meeting

Presentation Includes Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia (AML)

HOUSTON—May 23, 2024 – Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize^® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced an upcoming oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31- June 4, 2024 in Chicago, IL.

Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, will present interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). The data show prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

“We are honored that our abstract was selected by the ASCO Scientific Program Committee and Leadership for a prestigious oral presentation as part of a Rapid Oral Abstract Session. ASCO is the ideal setting to present these encouraging data, as it is the world's largest clinical cancer research meeting with more than 30,000 oncology professionals in attendance,” said Peter Nielsen, Chief Executive Officer of Bio-Path. “It is important to showcase these important data and expand awareness of prexigebersen within the field as it may encourage greater participation in this and our other prexigebersen studies.”

Details for the oral presentation are as follows:

Title: Interim Safety and Efficacy of BP1001 in a Phase II Acute Myeloid Leukemia Study

Date and Time: Saturday, June 1, 2024 at 8:00 AM CT

Location: McCormick Place

Abstract Number: 6511

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including lymphoma and acute myeloid leukemia. In addition, an IND is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.

For more information, please visit the Company's website at www.biopathholdings.com.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials

with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

# # #

Contact Information:

Investors

Will O’Connor

Stern Investor Relations, Inc.

212-362-1200

will@sternir.com

Doug Morris

Investor Relations

Bio-Path Holdings, Inc.

832-742-1369

EX-99.2 3 bpth-20240523xex99d2.htm EX-99.2

Exhibit 99.2

Bio-Path Holdings to Present Data at 2024 European Hematology Association Congress

Presentation Includes Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia (AML)

HOUSTON—May 24, 2024 – Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize^® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced an upcoming poster presentation at the 2024 European Hematology Association (EHA) Congress, taking place June 13-16, 2024 in Madrid, Spain.

Jorge Cortes, M.D., Director of the Georgia Cancer Center, will present interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). The data show prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

“We look forward to Dr. Cortes’ presentation of these very compelling data, which continue to demonstrate prexigebersen’s potential as a safe and effective treatment for AML,” said Peter Nielsen, Chief Executive Officer of Bio-Path. “We are particularly enthusiastic with its improvement over frontline therapy and are eager to have these data presented before an audience of the world’s leading hematologists at EHA.”

Details for the poster presentation are as follows:

Title: Interim Safety and Efficacy of BP1001 in a Phase II Acute Myeloid Leukemia Study

Date and Time: Friday, June 14, 2024 at 6:00 PM CEST

Location: IFEMA Madrid Recinto Ferial, Hall 7

Abstract Number: P536

About Bio-Path Holdings, Inc.

For more information, please visit the Company's website at www.biopathholdings.com.

Forward-Looking Statements

studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

# # #

Contact Information:

Investors

Will O’Connor

Stern Investor Relations, Inc.

212-362-1200

will@sternir.com

Doug Morris

Investor Relations

Bio-Path Holdings, Inc.

832-742-1369

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Document and Entity Information	May 23, 2024
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	May 23, 2024
Entity File Number	001-36333
Entity Registrant Name	BIO-PATH HOLDINGS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	87-0652870
Entity Address State Or Province	TX
Entity Address, Address Line One	4710 Bellaire Boulevard
Entity Address, Adress Line Two	Suite 210
Entity Address, City or Town	Bellaire
Entity Address, Postal Zip Code	77401
City Area Code	832
Local Phone Number	742-1357
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	BPTH
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001133818
Amendment Flag	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false

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