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): April 5, 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))

Item 7.01 Regulation FD Disclosure.

On April 5, 2017, Bio-Path Holdings, Inc. (the “Company”) issued a press release titled, “Bio-Path Holdings Presents Results Showing Potential of BP1002 as Treatment for Aggressive Non-Hodgkin's Lymphoma.” 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 April 5, 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: April 5, 2017	By:	/s/ Peter H. Nielsen
		Peter H. Nielsen President and Chief Executive Officer

EXHIBIT INDEX

Exhibit

Number Description

99.1 Press Release dated April 5, 2017

EX-99.1

Exhibit 99.1

Bio-Path Holdings Presents Results Showing Potential of BP1002 as Treatment for Aggressive Non-Hodgkin’s Lymphoma

- In Vivo and Preclinical Data Presented at AACR Annual Meeting -

HOUSTON—April 5, 2017 – 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 results of preclinical in vitro and in vivo studies supporting the potential of BP1002 in the treatment of aggressive non-Hodgkin’s lymphoma (NHL). These results are being presented at the annual meeting of the American Association for Cancer Research (AACR) taking place in Washington, DC.

The poster titled, “Activity of Bcl-2 antisense therapeutic in aggressive non-Hodgkin’s lymphoma,” summarizes results from two studies: an in vitro study in which 15 cells lines of aggressive NHL subtypes were incubated with BP1002; and two in vivo studies in which mice with follicular lymphoma xenografts were treated with BP1002. BP1002 was shown to have strong anti-NHL activity in each of these studies.

“Survival for patients with aggressive NHL has improved with the use of certain chemotherapy regimens, but the prognosis remains poor for the 30% of patients who relapse after treatment,” said Peter Nielsen, chief executive officer of Bio-Path Holdings. “Aggressive NHL is associated with high levels of Bcl-2 expression, making it an ideal candidate for treatment with BP1002, a potent and targeted inhibitor of Bcl-2. While these results are early, we believe they indicate a potential for BP1002 to provide a survival benefit to patients with aggressive NHL. We look forward to initiating a clinical study later this year to assess this candidate in patients with NHL.”

In the in vitro study, cell lines of germinal center B-cell lymphoma diffuse large B-cell lymphoma (DLBCL), activated B-cell DLBCL, mantle cell lymphoma and Burkitt’s lymphoma were incubated with BP1002. After four days, it was determined that BP1002 induced greater than 50% inhibition in 11 of the 15 cell lines tested. In the two animal studies, none of the untreated or control (empty liposome) mice survived beyond 39 days. In the BP1002 arms, a combined 87% of treated mice survived until the end of the 5-week studies.

About BP1002

BP1002 (Liposomal Bcl-2 antisense), Bio-Path’s second product candidate, is a neutral-charge, liposome-incorporated antisense drug designed to inhibit protein synthesis of Bcl-2, a protein that promotes cellular survival and inhibits apoptosis. Bcl-2 is overexpressed in a majority of non-Hodgkin’s lymphoma subtypes, including follicular lymphoma and diffuse large B cell lymphoma, as well as in a wide variety of solid tumors. Bio-Path is preparing to submit an investigational new drug (IND) application for BP1002, and is planning to initiate a Phase 1 clinical trial for lymphoma in 2017.

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company focused on developing therapeutic products utilizing DNAbilize™, its proprietary liposomal delivery and antisense technology, to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (Liposomal Grb2 antisense), is in a Phase 2 study for blood cancers and in preclinical studies for solid tumors. BP1002 is Bio-Path’s second liposomal antisense drug candidate, and is ready for the clinic where it will be evaluated in lymphoma and solid tumors.

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

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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