Centessa Pharmaceuticals Files 8-K

Ticker: CNTA · Form: 8-K · Filed: Apr 22, 2024 · CIK: 1847903

Centessa Pharmaceuticals PLC 8-K Filing Summary
FieldDetail
CompanyCentessa Pharmaceuticals PLC (CNTA)
Form Type8-K
Filed DateApr 22, 2024
Risk Levellow
Pages5
Reading Time6 min
Sentimentneutral

Sentiment: neutral

Topics: regulatory-filing, 8-k

TL;DR

Centessa filed an 8-K, looks like standard reporting, no major news.

AI Summary

Centessa Pharmaceuticals plc filed an 8-K on April 22, 2024, reporting on other events and financial statements. The filing does not contain specific financial figures or significant corporate actions beyond routine reporting requirements.

Why It Matters

This filing indicates Centessa Pharmaceuticals is meeting its regulatory reporting obligations with the SEC, but contains no new material information for investors.

Risk Assessment

Risk Level: low — The filing is a routine 8-K with no new material information, indicating no immediate change in risk.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing by Centessa Pharmaceuticals?

The primary purpose of this 8-K filing is to report on other events and financial statements as required by the SEC.

What is the exact date of the earliest event reported in this filing?

The date of the earliest event reported in this filing is April 22, 2024.

Where is Centessa Pharmaceuticals plc incorporated?

Centessa Pharmaceuticals plc is incorporated in England and Wales.

What is the SEC file number for Centessa Pharmaceuticals?

The SEC file number for Centessa Pharmaceuticals is 001-40445.

What is the principal executive office address for Centessa Pharmaceuticals?

The principal executive office address is 3rd Floor, 1 Ashley Road, Altrincham, Cheshire, WA14 2DT, United Kingdom.

Filing Stats: 1,426 words · 6 min read · ~5 pages · Grade level 14.5 · Accepted 2024-04-22 07:15:53

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On April 22, 2024, Centessa Pharmaceuticals plc (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") has cleared the Investigational New Drug application (the "IND") to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference . The Company from time to time presents and/or distributes slide presentations to the investment community at various industry and other conferences to provide updates and summaries of its business. The Company is posting a copy of its current corporate slide presentation to the "Investors" portion of its website at www.centessa.com/events-presentations. These slides are attached to this Current Report on Form 8-K as Exhibit 99.2. The information under this Item 7.01, including Exhibits 99.1 and 99.2 hereto, is being furnished and shall not be deemed "filed" for 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1 and 99.2.

01 Other Events

Item 8.01 Other Events. On April 22, 2024, the Company announced that the FDA has cleared the IND to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy. The Phase 1 study of ORX750 will evaluate the safety, tolerability and pharmacokinetics of single-ascending ("SAD") and multiple-ascending doses of ORX750 in healthy adult subjects. In parallel to the SAD, a cross-over proof-of-concept pharmacodynamic assessment will be performed utilizing the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects which is intended to provide proof-of-concept data to enable dose selection for NT1, NT2 and IH indications. The study has a maximum exposure limit specified by the FDA which the Company believes significantly exceeds the predicted efficacious doses of ORX750 in indications associated with or without orexin loss; therefore, the Company does not expect this limit to affect any of the planned clinical development activities for ORX750. The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024. The Phase 1 study design of ORX750 includes SAD combined with PoC cohorts to assess PD effects of ORX750 by measuring sleep latency with the MWT and subjective sleepiness with the KSS in acutely sleep-deprived healthy subjects.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. 99.1 P ress Rel ease dated April 22, 2024 99.2 Corporate Presentation as of April 22, 2024 104 Cover Page Interactive Data (embedded within the Inline XBRL document)

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K contains forward-looking statements. These statements may be identified by words such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "potential," "continue," "ongoing," "aim," "seek," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this Current Report on Form 8-K that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company's ability to discover and develop transformational medicines for patients; the timing of commencement of new studies or clinical trials of ORX750 and other potential orexin agonist candidates; research and clinical development plans and the timing thereof; the Company's ability to differentiate ORX750 and other potential orexin agonist candidates from other treatment options; the development and therapeutic potential of ORX750 and other potential orexin agonist candidates; predicted efficacious doses of ORX750; predicted timing of enrollment in the Company's Phase 1 first-in-human, clinical trial of ORX750, the Company's ability to successfully conduct its clinical development of ORX750 below the maximum exposure limit set by the FDA or, in the event the Company plans to exceed the maximum exposure limit, the Company's ability to successfully have the maximum exposure limit removed; and other regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this Current Report on Form 8-K are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set fo

SIGNATURES

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: April 22, 2024 By: /s/ Saurabh Saha Name: Saurabh Saha, M.D., Ph.D. Title: Chief Executive Officer

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