Ionis Pharmaceuticals Files 8-K Report

Ticker: IONS · Form: 8-K · Filed: Sep 2, 2025 · CIK: 874015

Sentiment: neutral

Topics: financial-statements, exhibits, regulation-fd

Related Tickers: IONS

TL;DR

IONIS filed an 8-K, likely with financial updates. Check for details.

AI Summary

On September 2, 2025, Ionis Pharmaceuticals, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, and other events, indicating potential updates or disclosures relevant to the company's financial health and operations.

Why It Matters

This 8-K filing by Ionis Pharmaceuticals may contain important updates regarding financial performance or significant corporate events that could impact investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for financial statements and exhibits, not indicating immediate or significant negative events.

Key Players & Entities

FAQ

What specific financial statements or exhibits are included in this 8-K filing?

The filing indicates that financial statements and exhibits are included, but the specific details of these documents are not provided in the initial header information.

What 'Other Events' are being reported by Ionis Pharmaceuticals on September 2, 2025?

The filing lists 'Other Events' as an item information category, but the nature of these events is not detailed in the provided header.

What is the primary purpose of this 8-K filing for Ionis Pharmaceuticals?

The primary purpose appears to be the disclosure of financial statements and exhibits, along with reporting on other events and Regulation FD disclosures.

When was Ionis Pharmaceuticals previously known as ISIS PHARMACEUTICALS INC?

The date of the name change from ISIS PHARMACEUTICALS INC to IONIS PHARMACEUTICALS, INC. was March 28, 1993.

What is the principal executive office address for Ionis Pharmaceuticals?

The principal executive offices are located at 2855 Gazelle Court, Carlsbad, CA 92010.

Filing Stats: 1,164 words · 5 min read · ~4 pages · Grade level 12.4 · Accepted 2025-09-02 07:05:42

Filing Documents

01

Item 7.01 Regulation FD Disclosure. On September 2, 2025, Ionis Pharmaceuticals, Inc. ("Ionis," "we," "us" or "our company") issued a press release announcing positive topline results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia ("sHTG"). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 and the exhibit attached hereto 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, regardless of any general incorporation language in such filing.

01

Item 8.01 Other Events. On September 2, 2025, we announced positive topline results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with sHTG. In the studies, olezarsen demonstrated a highly statistically significant placebo-adjusted mean reduction in fasting triglycerides of up to 72% and a highly statistically significant reduction in acute pancreatitis events of 85% with favorable safety and tolerability. CORE and CORE2 make up the largest pivotal program for sHTG, with nearly 1,100 patients who were required to be on standard of care lipid-lowering therapy throughout the treatment period. The CORE and CORE2 studies met the primary endpoint, with both 80 mg and 50 mg monthly doses of olezarsen demonstrating a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride levels at six months: Olezarsen 80 mg Olezarsen 50 mg Placebo CORE Percent reduction from baseline 1 73% 63% 0.5% Percent placebo-adjusted reduction 2 72% 63% P-value 3 p<0.0001 p<0.0001 CORE2 Percent reduction from baseline 1 68% 63% 14% Percent placebo-adjusted reduction 2 55% 49% P-value 3 p<0.0001 p<0.0001 1. Least-squares mean. 2. Least-squares mean difference of percent reduction in fasting triglycerides. 3. P-values are based on comparison between each olezarsen group and placebo group in percent reduction in fasting triglycerides. Additionally, the studies met the secondary endpoint of reduction in acute pancreatitis events. Olezarsen demonstrated a highly statistically significant 85% reduction in events (p=0.0002) compared to placebo. This was a prespecified analysis of pooled olezarsen groups compared to pooled placebo groups across both studies at 12 months. Olezarsen demonstrated a favorable safety and tolerability profile. Adverse events were generally balanced across treatment groups, and serious adverse events occurred less frequently in the olezarsen groups compared to placebo. Injection site r

Forward-Looking Statements

Forward-Looking Statements Certain statements contained in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include, without limitation, statements regarding Ionis' business, the therapeutic and commercial potential of olezarsen, our commercial medicines, additional medicines in development and technologies, and Ionis' expectations regarding development and regulatory milestones. Words such as "anticipate," "believe," "could," "continue," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. For such statements, Ionis claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Ionis' expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Additional factors that could cause actual results to differ materially from those stated or implied by Ionis' forward-looking statements are disclosed in Ionis' filings with the Securities and Exchange Commission, including in the section captioned "Risk Factors" in Ionis' most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on For

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release dated September 2, 2025. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Ionis Pharmaceuticals, Inc. Dated: September 2, 2025 By: /s/ Patrick R. O'Neil Patrick R. O'Neil Executive Vice President, Chief Legal Officer and General Counsel

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