0001213900-19-009328.txt : 20190521 0001213900-19-009328.hdr.sgml : 20190521 20190521163433 ACCESSION NUMBER: 0001213900-19-009328 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20190515 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190521 DATE AS OF CHANGE: 20190521 FILER: COMPANY DATA: COMPANY CONFORMED NAME: XYNOMIC PHARMACEUTICALS HOLDINGS, INC. CENTRAL INDEX KEY: 0001697805 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: D8 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38120 FILM NUMBER: 19842847 BUSINESS ADDRESS: STREET 1: 609-610 21ST CENTURY TOWER STREET 2: 40 LIANGMAQIAO ROAD, CHAOYANG DISTRICT CITY: BEIJING STATE: F4 ZIP: 100016 BUSINESS PHONE: 9493506999 MAIL ADDRESS: STREET 1: 609-610 21ST CENTURY TOWER STREET 2: 40 LIANGMAQIAO ROAD, CHAOYANG DISTRICT CITY: BEIJING STATE: F4 ZIP: 100016 FORMER COMPANY: FORMER CONFORMED NAME: Bison Capital Acquisition Corp. DATE OF NAME CHANGE: 20170621 FORMER COMPANY: FORMER CONFORMED NAME: Bison Capital Acquisition Corp DATE OF NAME CHANGE: 20170209 8-K 1 f8k051519_xynomicpharma.htm CURRENT REPORT

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 21, 2019 (May 15, 2019)

XYNOMIC PHARMACEUTICALS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38120		83-4696467
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

Suite 3306, K. Wah Centre, 1010 Middle Huaihai Road, Shanghai, China		200031
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number including area code: +86 21 54180212

Bison Capital Acquisition Corp.

(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 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. ☐

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered

Item 8.01 Other Events.

On May 21, 2019, Xynomic Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release announcing that long-term follow up data of exceptional responders to abexinostat/pazopanib will be presented by Dr. Rahul Aggarwal, a lead investigator at the University of California, San Francisco (“UCSF”) on June 1, 2019. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit		Description
99.1		Press Release dated May 21, 2019

SIGNATURE

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

	XYNOMIC PHARMACEUTICALS HOLDINGS, INC

May 21, 2019	By:	/s/ Yinglin Mark Xu
		Yinglin Mark Xu
		Chairman of the Board, Chief Executive Officer, President and Interim Chief Financial Officer

EX-99.1 2 f8k051519ex99-1_xynomic.htm PRESS RELEASE DATED MAY 21, 2019

Exhibit 99.1

Xynomic Pharma To Present Long-Term Follow Up Data Showing Abexinostat, Combined with Pazopanib, has Durable Responses in Patients with Pre-Treated Kidney Cancer

RALEIGH, N.C. and SHANGHAI, May 21, 2019 (GLOBE NEWSWIRE) -- Xynomic Pharmaceuticals Holdings, Inc. (“Xynomic”), a clinical stage US-China oncology drug development company (Nasdaq: XYN), announced today that long-term follow up data of exceptional responders to abexinostat/pazopanib will be presented by Dr. Rahul Aggarwal, a lead investigator at the University of California, San Francisco (“UCSF”). Dr. Aggarwal will present the information at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, IL on June 1, 2019 in a presentation titled “Exceptional Responders to Abexinostat (“ABX”) Plus Pazopanib (“PAZ”) in Pre-Treated Renal Cell Carcinoma (“RCC”) and Other Solid Tumors: Long-Term Follow Up of a Phase 1b Study” (Abstract No: 3022).

The initial results from the Phase 1b study of Xynomic’s potent pan-HDAC inhibitor ABX plus PAZ demonstrated acceptable toxicity profile and encouraging anti-tumor activity (Aggarwal et al. Journal of Clinical Oncology, 2017). In this trial, 51 patients (including 22 RCC patients) were enrolled between June 2012 and October 2015. Among them, 10 patients (20%) had experienced disease progression on prior PAZ; 30 patients (59%) had received prior vascular endothelial growth factor (“VEGF”) targeted therapy.

The ASCO presentation long-term follow up data of exceptional responders and additional correlative analyses associated with clinical outcomes. In particular, as of February 2019, among the 10 patients who had experienced disease progression on prior PAZ treatment, 5 patients achieved durable partial response (“PR”) lasting for more than 2 years, and 1 patient who was previously a PAZ-refractory patient with RCC, remained on treatment with ongoing PR, for more than 6 years. In addition, higher peripheral blood HDAC2 expression was associated with prolonged progression-free survival (median PFS 5.9 vs. 3.5 months, log-rank p=0.02). Induction of histone acetylation on ABX lead-in treatment was associated with subsequent time to progression (p=0.002). On-treatment plasma VEGF levels were inversely correlated with PBMC histone acetylation (p=0.02). The new data demonstrate that (1) marketed durable responses with ABX + PAZ are achievable, including in patients with PAZ- and VEGF-refractory RCC and other solid tumor malignancies, and (2) host factors including HDAC expression and acetylation status may identify those patients most likely to benefit from this combination therapy.

A global, randomized pivotal Phase 3 trial is underway of ABX + PAZ as a first- or second-line therapy in patients with locally advanced or metastatic RCC (RENAVIV; NCT03592472). The U.S. Food and Drug Administration has granted Fast Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of RCC.

About Xynomic Pharmaceuticals Holdings, Inc.
Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of 3 drug candidates; Xynomic owns global exclusive development, manufacturing and commercialization rights to each of these. Its lead drug candidate abexinostat is in global potentially pivotal clinical trials against renal cell carcinoma (in combination with pazopanib) and non-Hodgkin’s lymphoma (as a single agent). Xynomic’s other clinical stage drug candidate XP-105 (BI 860585) is a Phase 2 ready, ATP-competitive mTORC1/2 inhibitor against solid tumors. Xynomic’s pre-clinical oncology drug candidate XP-102 (BI 882370) is a pan-RAF inhibitor.

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