8-K
false 0001718852 0001718852 2022-06-08 2022-06-08

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): June 8, 2022

 

 

PROMETHEUS BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-40187   81-4282653

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

3050 Science Park Road

San Diego, California 92121

(Address of principal executive offices) (Zip Code)

(858) 422-4300

(Registrant’s telephone number, include area code)

N/A

(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(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   RXDX   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 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 8.01.

Other Events.

Prometheus Biosciences, Inc. (the “Company”) announced that it has completed enrollment for APOLLO-CD, a global Phase 2a study of PRA023 in Crohn’s Disease (“CD”) and that enrollment remains on track in the Phase 2 study of PRA023 for ARTEMIS-UC in ulcerative colitis (“UC”) with enrollment completion of cohort 1 expected in the third quarter of this year. Topline results from both APOLLO-CD and the initial cohort of ARTEMIS-UC are expected in the fourth quarter of this year. Topline results from the Company’s Phase 2 trial of PRA023 in Systemic Sclerosis-Associated Interstitial Lung Disease, ATHENA-SSc-ILD, are expected in the first half of 2024.

In addition, the Company announced that it remains on track for implementing its 200 mg/ml subcutaneous formulation for potential future registrational studies in UC and CD. In the first quarter of this year, the Company initiated a subcutaneous bridging study by dosing Caucasian normal healthy volunteers with PRA023 to assess the bioavailability of the subcutaneous formulation. The Company also initiated dosing of healthy volunteers of Japanese descent with PRA023 as part of the bridging study to assess safety, tolerability, and pharmacokinetics.

Forward Looking Statements

Prometheus cautions readers that statements contained in this report regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the timing of Prometheus’ APOLLO-CD, ARTEMIS-UC and ATHENA-SSc-ILD clinical trials; and Prometheus’ ability to implement its subcutaneous formulation of PRA023 for potential future registrational studies in UC and CD. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of precision medicines based on Prometheus360TM is unproven, and we do not know whether we will be able to develop any therapeutics or companion diagnostic products of commercial value; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; we are early in our development efforts and have only one product candidate in early clinical development and all of our other development programs are in the preclinical or discovery stage; disruption to our operations from the COVID-19 pandemic; the success of clinical trials and preclinical studies for our product candidates; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; we may not realize any benefits from our current and any future collaborations; our dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; our ability to develop companion diagnostics for our therapeutic product candidates; regulatory developments in the United States and foreign countries, including acceptance of INDs and similar foreign regulatory filings and the proposed design of future clinical trials; our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; we may use our capital resources sooner than we expect; and other risks described in our filings with the SEC, including under the heading “Risk Factors” in our Form 10-K filed with the SEC on March 9, 2022 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.


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.

 

   

PROMETHEUS BIOSCIENCES, INC.

Date: June 8, 2022

   

By:

 

/s/ Timothy K. Andrews

     

Timothy K. Andrews

     

General Counsel and Secretary