FDA clears Intellia (Nasdaq: NTLA) MAGNITUDE trial; ATM capacity raised
Rhea-AI Filing Summary
Intellia Therapeutics expanded its at-the-market stock offering program with Jefferies, increasing capacity from
Separately, the FDA removed the clinical hold on the MAGNITUDE Phase 3 trial of nexiguran ziclumeran for transthyretin amyloidosis with cardiomyopathy after prior Grade 4 liver enzyme elevations. Intellia and the FDA agreed on added liver and cardiac safety exclusions and enhanced monitoring, allowing enrollment activities in both MAGNITUDE and MAGNITUDE-2 to resume.
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Insights
Key drug trial restarts as Intellia expands its ATM funding flexibility.
Intellia Therapeutics increased its at-the-market equity program with Jefferies from
On the pipeline side, the FDA removed the clinical hold on the MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z) in ATTR-CM after earlier Grade 4 liver transaminase and bilirubin elevations triggered a pause on
MAGNITUDE is designed to enroll about 1,200 patients, with a composite cardiovascular event primary endpoint and single 55 mg infusion dosing. MAGNITUDE-2 targets about 60 patients with ATTRv-PN. Actual impact on Intellia’s outlook will depend on successful enrollment, safety under the new criteria, and future data readouts described in subsequent company filings.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
Intellia Therapeutics, Inc. (the “Company”) previously entered into an Open Market Sale Agreement, dated March 4, 2022, and amended on February 23, 2024 (as amended, the “Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $750,000,000, through Jefferies as its sales agent. Pursuant to the Sales Agreement, the sale and issuance of the shares under the Sales Agreement were originally made pursuant to a registration statement on Form S-3ASR (File No. 333-251022) filed on November 30, 2020 (the “Prior Prospectus”) and subsequently pursuant to an effective registration statement on Form S-3ASR (File No. 333-275740) filed on November 24, 2023 (the “Existing Registration Statement”) and a prospectus supplement filed on February 23, 2024 (together with the Existing Registration Statement, the “Existing Prospectus”) with the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended (the “Securities Act”).
On March 2, 2026, the Company entered into an amendment to the Sales Agreement to increase the size of the at-the-market offering program from $750,000,000 to $1,035,316,650. As of the date of this Current Report on Form 8-K, we have sold approximately $635,316,650 of shares of Common Stock under the Sales Agreement pursuant to the Prior Prospectus and the Existing Prospectus, including any supplements thereto that we have filed from time to time. On March 2, 2026, we will file a prospectus supplement (the “New Prospectus”) to our Existing Prospectus, which will update the Existing Prospectus. The New Prospectus covers the offer and sale of up to $400,000,000 of shares of Common Stock (the “Additional Shares”) from time to time through Jefferies, acting as our sales agent, which is inclusive of the approximately $114,683,350 of shares of Common Stock that are not yet sold pursuant to the Existing Prospectus.
Upon delivery of a placement notice and subject to the terms and conditions of the amended Sales Agreement, sales of the shares of Common Stock under the Sales Agreement may be made by any method that is deemed an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the Securities Act). We are not obligated to make any sales of shares of Common Stock under the amended Sales Agreement.
Under the amended Sales Agreement, we or Jefferies may suspend the offering of shares being made through Jefferies, upon proper written notice to the other party. Jefferies will act as sales agent on a best efforts basis and has agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the Nasdaq Global Market to sell shares of Common Stock up to the number or amount specified in, and otherwise in accordance with the terms of, a placement notice delivered pursuant to the amended Sales Agreement.
We will continue to pay Jefferies compensation for its services in cash up to 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the terms of the amended Sales Agreement. We also agreed to provide indemnification and contribution to Jefferies with respect to certain liabilities.
Jefferies and/or its affiliates have provided, and may in the future provide various investment banking, commercial banking and other financial services to us and/or our affiliates, for which services they may in the future receive customary fees. To the extent required by Regulation M of the Securities Exchange Act of 1934, as amended, Jefferies will not engage in any market making activities involving our common stock while the offering is ongoing under the prospectus and prospectus supplement.
The foregoing description of the material terms of the Sales Agreement, as amended, is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which was filed as Exhibit 99.1 to the Current Report on Form 8-K filed on March 4, 2022, which is incorporated herein by reference, the amendment to the Sales Agreement, a copy of which was filed as Exhibit 99.1 to the Current Report on Form 8-K filed on February 23, 2024, which is incorporated herein by reference, and the amendment to the Sales Agreement, which is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Goodwin Procter LLP, our counsel, has issued a legal opinion relating to the Additional Shares being offered pursuant to the New Prospectus. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 to this Current Report on Form 8-K. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.
Item 7.01 Regulation FD Disclosure.
On March 2, 2026, Intellia issued a press release titled “Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE Phase 3 Clinical Trial in ATTR-CM.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information under this Item 7.01, including Exhibit 99.2 hereto, is being furnished herewith and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On March 2, 2026, Intellia announced that the U.S. Food and Drug Administration (“FDA”) has removed the clinical hold on the investigational new drug application (“IND”) for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran (“nex-z”) for patients with transthyretin (“ATTR”) amyloidosis with cardiomyopathy (“ATTR-CM”). On October 29, 2025, the FDA imposed a clinical hold on the INDs for the MAGNITUDE Phase 3 trial and the MAGNITUDE-2 Phase 3 clinical trial of nex-z for patients with hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”) following the observation of Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in MAGNITUDE that met the trial’s protocol-defined pausing criteria. The Company has aligned with the FDA on mitigation measures for MAGNITUDE and MAGNITUDE-2 that include enhanced monitoring of liver laboratory tests, guidance for short-term steroid treatment if elevated liver transaminases are observed in the initial period following dosing and the exclusion of patients with certain liver abnormalities. For MAGNITUDE, additional exclusion criteria are being incorporated for patients with a recent history of cardiovascular instability and those with ejection fraction <25% at the time of screening. Intellia is engaged with clinical trial investigators, ethics committees, international regulatory authorities and other stakeholders to resume enrollment activities in MAGNITUDE and MAGNITUDE-2.
Forward-Looking Statements
This Current Report on Form 8-K and certain of the materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding: the safety, tolerability, efficacy, success and advancement of its clinical programs for nex-z for ATTR amyloidosis, including its MAGNITUDE Phase 3 study of nex-z for the treatment of ATTR-CM and its MAGNITUDE-2 Phase 3 study of nex-z for the treatment of ATTRv-PN; and its ability to engage with clinical trial investigators, ethics committees, international regulatory authorities and other stakeholders to resume enrollment activities in MAGNITUDE and MAGNITUDE-2.
Any forward-looking statements in this current report on Form 8-K are based on management’s current expectations and beliefs regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: regulatory agencies’ evaluation of regulatory filings and other information related to our product candidates, including nex-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for Intellia’s product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; the risk that any one or more of Intellia’s product candidates, including nex-z, will not be successfully developed and commercialized; risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia’s other product candidates; and risks related to Intellia’s reliance on collaborations, including that its collaboration with Regeneron Pharmaceuticals, Inc. will not continue or will not be successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. All information in this current report on Form 8-K is as of the date of the report, and Intellia undertakes no duty to update this information unless required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 5.1 | Opinion of Goodwin Procter LLP | |
| 99.1 | Amendment No. 2 to the Open Market Sale AgreementSM, dated as of March 2, 2026, by and between Intellia Therapeutics, Inc. and Jefferies LLC | |
| 99.2 | Press Release dated March 2, 2026, titled “Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE Phase 3 Clinical Trial in ATTR-CM” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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 thereunto duly authorized.
| Intellia Therapeutics, Inc. | ||||||
| Date: March 2, 2026 | By: | /s/ John M. Leonard | ||||
| Name: John M. Leonard | ||||||
| Title: Chief Executive Officer and President | ||||||
Exhibit 99.1
AMENDMENT NO. 2 TO THE OPEN MARKET SALE AGREEMENTSM
March 2, 2026
JEFFERIES LLC
520 Madison Avenue
New York, New York 10022
Ladies and Gentlemen:
This Amendment No. 2 to the Open Market Sale AgreementSM, dated as of March 2, 2026, is entered into by and between Intellia Therapeutics, Inc. (the “Company”) and Jefferies LLC (the “Agent”). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to them in the Sales Agreement (as defined below).
WHEREAS, the Company and the Agent have entered into that certain Open Market Sale AgreementSM, dated March 4, 2022, as amended by that certain Amendment to the Open Market Sale AgreementSM, dated as of February 23, 2024 (the “Sales Agreement”), with respect to the issuance and sale of the Common Shares; and
WHEREAS, the Company and the Agent desire to amend the Sales Agreement as set forth herein.
NOW, THEREFORE, in consideration of the foregoing, the Company and the Agent hereby amend the Sales Agreement as follows:
1. The preamble on page 1 of the Sales Agreement shall be amended such that the reference to “$750,000,000” shall be “$1,035,316,650”.
2. The first sentence of the Issuance Notice attached as Exhibit A to the Sales Agreement is amended to add the words “and March 2, 2026” immediately after “March 4, 2022, as amended on February 23, 2024”.
3. Schedule A of the Sales Agreement shall be amended such that the reference to “Glen Goddard (glen.goddard@intelliatx.com)” shall be “Edward Dulac (Edward.dulac@intelliatx.com)”.
4. The Company shall file a Prospectus Supplement pursuant to Rule 424(b) of the Securities Act of 1933, as amended, reflecting this Amendment within two Business Days of the date hereof.
5. This Amendment shall be and is hereby incorporated in and forms a part of the Sales Agreement.
6. This Amendment shall be effective as of the date first above written.
7. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed Amendment by one party to the other may be made by facsimile or electronic transmission.
8. This Amendment shall, by this express agreement of the parties, be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to the conflicts of law provisions of the laws of the State of New York. The Company and the Agent each hereby consents to the application of New York civil law to the construction, interpretation and enforcement of this Amendment, and to the application of New York civil law to the procedural aspects of any suit, action or proceeding relation thereto, including but not limited to legal process, execution of judgments and other legal remedies.
9. Except as set forth herein, the Sales Agreement shall remain in full force and effect.
[Signature Pages Follow]
2
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date first above written.
| INTELLIA THERAPEUTICS, INC. | ||
| By | /s/ John M. Leonard | |
| Name: John M. Leonard Title: Chief Executive Officer and President | ||
| JEFFERIES LLC | ||
| By | /s/ Michael Magarro | |
| Name: Michael Magarro Title: Managing Director | ||
Exhibit 99.2
Intellia Therapeutics Announces FDA Lift of Clinical Hold on
MAGNITUDE Phase 3 Clinical Trial in ATTR-CM
CAMBRIDGE, Mass., March 2, 2026 – Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran (nex-z) for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
“We are very pleased to have aligned with the FDA on the path forward for our MAGNITUDE clinical trial, with measures designed to further enhance patient safety and allow us to continue to investigate nex-z in a broad ATTR-CM population,” said Intellia President and Chief Executive Officer John Leonard, M.D. “With the resolution in January of the clinical hold on our MAGNITUDE-2 Phase 3 trial for patients with hereditary ATTR with polyneuropathy, our attention now turns to completing enrollment in both ongoing trials. We appreciate the FDA’s responsiveness throughout this process and thank the many investigators and patients who are participating in these trials.”
The clinical holds on the INDs for MAGNITUDE and MAGNITUDE-2 were imposed by the FDA on October 29, 2025, following the observation of Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in MAGNITUDE that met the trial’s protocol-defined pausing criteria. The company has aligned with the FDA on mitigation measures for MAGNITUDE and MAGNITUDE-2 that include enhanced monitoring of liver laboratory tests, guidance for short-term steroid treatment if elevated liver transaminases are observed in the initial period following dosing and the exclusion of patients with certain liver abnormalities. For MAGNITUDE, additional exclusion criteria are being incorporated for patients with a recent history of cardiovascular instability and those with ejection fraction <25% at the time of screening. Intellia is engaged with clinical trial investigators, ethics committees, international regulatory authorities and other stakeholders to resume enrollment activities in MAGNITUDE and MAGNITUDE-2.
MAGNITUDE is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of nex-z in approximately 1,200 patients with ATTR-CM. The primary endpoint of the trial is based on a composite measure of cardiovascular-related events, including mortality. Adult patients with ATTR-CM are randomized 2:1 to receive a single 55 mg infusion of nex-z or placebo. For more information on MAGNITUDE (NCT06128629), please visit clinicaltrials.gov.
| Page 1 of 3 | intelliatx.com |
MAGNITUDE-2 is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of nex-z in approximately 60 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN). The primary endpoints of the study are a change in modified neuropathy impairment score and a change in serum TTR levels. Adult patients with ATTRv-PN are randomized 1:1 to receive a single 55 mg infusion of nex-z or placebo. For more information on MAGNITUDE-2 (NCT06672237), please visit clinicaltrials.gov.
About Nex-z
Based on Nobel Prize-winning CRISPR/Cas9 gene editing technology, nex-z has the potential to become the first one-time treatment for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) and/or hereditary ATTR with polyneuropathy (ATTRv-PN). Nex-z is designed to inactivate the TTR gene that encodes for the transthyretin (TTR) protein and is being investigated in MAGNITUDE and MAGNITUDE-2, Phase 3 clinical trials in ATTR-CM and ATTRv-PN, respectively. Interim Phase 1 clinical data showed the administration of nex-z led to consistent, deep and long-lasting TTR reduction. Nex-z has received an Orphan Drug and RMAT Designation from the U.S. Food and Drug Administration (FDA) and an Orphan Drug Designation (ODD) from the European Commission. Intellia leads development and commercialization of nex-z as part of a multi-target discovery, development and commercialization collaboration with Regeneron Pharmaceuticals, Inc.
About Intellia Therapeutics
Intellia Therapeutics, Inc. (Nasdaq: NTLA) is a leading clinical-stage biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies. The company’s mission is to transform the lives of people with severe diseases by developing and commercializing potentially curative treatments. With deep scientific, technical and clinical development experience, Intellia aims to reset the standard for medicine by durably treating the root causes of disease. Learn more at intelliatx.com and follow us @intelliatx.
Forward-Looking Statements
This press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding: the safety, tolerability, efficacy, success and advancement of its clinical programs for nexiguran ziclumeran or “nex-z” (also known as NTLA-2001), including the ability to engage with clinical trial
| Page 2 of 3 | intelliatx.com |
investigators, ethics committees, international regulatory authorities and other stakeholders to resume enrollment activities in its MAGNITUDE and MAGNITUDE-2 trials for nex-z in ATTR-CM and ATTRv-PN, the ability to successfully complete the MAGNITUDE and MAGNITUDE-2 trials, and the potential of nex-z to become the first one-time treatment for ATTR-CM and/or ATTRv-PN.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: regulatory agencies’ evaluation of regulatory filings and other information related to our product candidates, including nex-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; the risk that any one or more of Intellia’s product candidates, including nex-z, will not be successfully developed and commercialized; risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia’s other product candidates; and risks related to Intellia’s reliance on collaborations, including that its collaboration with Regeneron Pharmaceuticals, Inc. will not continue or will not be successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law.
# # #
Contact:
Jason Fredette
Vice President, Investor Relations and Corporate Communications
Intellia Therapeutics, Inc.
jason.fredette@intelliatx.com
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FAQ
What change did Intellia Therapeutics (NTLA) make to its at-the-market stock program?
How much additional stock can Intellia Therapeutics (NTLA) sell under the new prospectus?
What did the FDA decide about Intellia’s MAGNITUDE Phase 3 trial in ATTR-CM?
Why were Intellia’s MAGNITUDE and MAGNITUDE-2 trials previously placed on clinical hold?
What safety measures were added for Intellia’s MAGNITUDE and MAGNITUDE-2 studies?
How large are Intellia’s MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nex-z?
Filing Exhibits & Attachments
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