Allena Pharmaceuticals (ALNAQ) 8-K Allena Pharmaceuticals Reports Positive Reloxaliase Topline Results fromURIROX-1 Trial and from Study 206

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM8-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 7, 2019

Allena Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

DELAWARE	001-38268	45-2729920
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

One Newton Executive Park, Suite 202 Newton, Massachusetts	02462
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code(617) 467-4577

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form8-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 toRule 14a-12 under the Exchange Act (17 CFR240.14a-12)

☐ Pre-commencement communications pursuant toRule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))

☐ Pre-commencement communications pursuant toRule 13e-4(c) under the Exchange Act (17 CFR240.13e-4(c))

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	ALNA	The Nasdaq Global Select 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 Rule12b-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 7, 2019, Allena Pharmaceuticals, Inc. (the “Company”) conducted a conference call reviewing topline results fromURIROX-1, the Company’s first Phase 3 pivotal trial evaluating reloxaliase, an orally-administered, recombinant oxalate-degrading enzyme therapeutic candidate, in patients with enteric hyperoxaluria (“EH”), as well as additional data from Study 206, the Company’s Phase 2 trial evaluating reloxaliase in high-risk patients with EH and advanced chronic kidney disease (“CKD”). A copy of the presentation slide deck is being furnished as Exhibit 99.2 to this Report onForm 8-K.

The information in this report furnished pursuant to Item 7.01 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report

Item 8.01 Other Events.

On November 7, 2019, the Company issued a press release announcing topline results fromURIROX-1, the Company’s first Phase 3 pivotal trial evaluating reloxaliase, an orally-administered, recombinant oxalate-degrading enzyme therapeutic candidate, in patients with EH, as well as additional data from Study 206, the Company’s Phase 2 trial evaluating reloxaliase in high-risk patients with EH and advanced CKD. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release by Allena Pharmaceuticals, Inc. dated November 7, 2019
99.2	Investor Presentation dated November 7, 2019 furnished by Allena Pharmaceuticals, Inc.

SIGNATURES

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: November 7, 2019	Allena Pharmaceuticals, Inc.
	By:	/s/ Edward Wholihan
		Edward Wholihan
		Chief Financial Officer