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): November 6, 2017

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))

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 November 6, 2017, Bio-Path Holdings, Inc. (the “Company”) issued a press release titled, “Bio-Path Holdings Highlights Advancements in Preclinical Discovery Efforts.” A copy of such press release is attached hereto as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number Description

99.1 Press Release dated November 6, 2017

SIGNATURES

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

	BIO-PATH HOLDINGS, INC.
Dated: November 7, 2017	By:	/s/ Peter H. Nielsen
		Peter H. Nielsen President and Chief Executive Officer

EXHIBIT INDEX

Exhibit
Number Description

99.1 Press Release dated November 6, 2017

EX-99.1

Exhibit 99.1

Bio-Path Holdings Highlights Advancements in Preclinical Discovery Efforts

Selects New Drug Compound, BP1003, for Treatment of Pancreatic Cancer

HOUSTON—November 6, 2017 – Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize^® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced the selection of its third drug candidate, BP1003, for the treatment of pancreatic cancer and provided an update on several of its preclinical discovery efforts.

“We are excited about the ways in which we continue to leverage our novel DNAbilize^® technology and are particularly pleased to be moving forward toward the treatment of solid tumors,” said Peter H. Nielsen, chief executive officer of Bio-Path Holdings. “As we advance our current drug candidates into additional indications and add new targets, we continue to establish the DNAbilize^® platform as a premier RNAi nanoparticle technology for systemic treatment of disease.”

Bio-Path’s third drug candidate, BP1003, targets the Stat3 protein and is currently in preclinical development in a pancreatic patient-derived tumor model. Previous preclinical models have shown BP1003 to successfully penetrate pancreatic tumors and to significantly enhance the efficacy of standard frontline treatments. Bio-Path intends to initiate IND enabling studies of BP1003 in 2018.

BP1002, Bio-Path’s second drug candidate, targets the Bcl2 protein and has demonstrated strong anti-non-Hodgkin’s lymphoma activity in cell lines and in an animal model. The company has completed IND enabling studies and expects to initiate a Phase 1 trial in lymphoma in 2018.

Prexigebersen, Bio-Path’s lead drug compound, targets the Grb2 protein and is currently in Phase 2 development for the treatment of blood cancers. In recently completed preclinical models, prexigebersen effectively penetrated ovarian tumors and has demonstrated clinical benefit both as a monotherapy and in combination with standard frontline therapies. Bio-Path plans to initiate a Phase 1 clinical trial of prexigebersen targeting several solid tumors types in 2018.

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 in preclinical studies for solid tumors. This is followed by BP1002, targeting the Bcl2 protein, which the company anticipates entering into clinical studies where it will be evaluated in lymphoma and solid tumors.

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

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Contact Information:

Investors

Will O’Connor

Stern Investor Relations

212-362-1200

will@sternir.com

Doug Morris

Investor Relations

Bio-Path Holdings, Inc.

832-742-1369