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    SEC Form SC TO-T filed by Regulus Therapeutics Inc.

    5/27/25 6:56:25 AM ET
    $RGLS
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $RGLS alert in real time by email
    SC TO-T 1 tm2516065-1_sctot.htm SC TO-T tm2516065-1_sctot - none - 1.9687601s
    ​
    ​
    ​
    UNITED STATES
    SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549
    SCHEDULE TO
    TENDER OFFER STATEMENT UNDER SECTION 14(D)(1) OR (13)(E)(1)
    OF THE SECURITIES EXCHANGE ACT OF 1934
    REGULUS THERAPEUTICS INC.
    (Name of Subject Company (Issuer))​
    REDWOOD MERGER SUB INC.
    (Offeror)
    an indirect wholly owned subsidiary of​
    NOVARTIS AG
    (Offeror)
    (Name of Filing Persons (identifying status as offeror, issuer or other person))​
    Common Stock, par value $0.001 per share
    (Title of Class of Securities)​
    75915K309
    (CUSIP Number of Class of Securities)​
    Karen L. Hale
    Chief Legal and Compliance Officer
    Novartis AG
    Lichstrasse 35
    CH-4056 Basel
    Switzerland
    Telephone: +41-61-324-1111
    (Name, Address, and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)​
    With a copies to:
    Catherine J. Dargan, Esq.
    Michael J. Riella, Esq.
    Kerry S. Burke, Esq.
    Covington & Burling LLP
    One CityCenter
    850 Tenth Street, NW
    Washington, DC 20001-4956
    +1 (202) 662-6000
    ☐
    Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.
    ​
    Check the appropriate boxes below to designate any transactions to which the statement relates:
    ☒
    Third-party tender offer subject to Rule 14d-1.
    ​
    ☐
    Issuer tender offer subject to Rule 13e-4.
    ​
    ☐
    Going-private transaction subject to Rule 13e-3.
    ​
    ☐
    Amendment to Schedule 13D under Rule 13d-2.
    ​
    Check the following box if the filing is a final amendment reporting the results of the tender offer:   ☐
    If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:
    ☐
    Rule 13e-4(i) (Cross-Border Issuer Tender Offer)
    ​
    ☐
    Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)
    ​
    ​
    ​

    ​
     
    This Tender Offer Statement on Schedule TO (together with any amendments and supplements hereto, this “Schedule TO”) is filed by (i) Redwood Merger Sub Inc., a Delaware corporation (“Purchaser”) and an indirect wholly owned subsidiary of Novartis AG, a company limited by shares (Aktiengesellschafl) incorporated under the laws of Switzerland (“Parent”), and (ii) Parent. This Schedule TO relates to the offer by Purchaser (the “Offer”) to purchase all of the outstanding shares of common stock, par value $0.001 per share (the “Shares”), of Regulus Therapeutics Inc., a Delaware corporation (“Regulus”), in exchange for (i) $7.00 in cash per Share, subject to any applicable withholding and without interest thereon, plus (ii) one contingent value right (each, a “CVR”) per Share, representing the right to receive one contingent payment of $7.00 in cash, subject to any applicable withholding and without interest thereon, upon the achievement of the milestone specified in, and on the other terms and subject to the other conditions set forth in, the CVR Agreement (the “CVR Agreement”) to be entered into between Parent and a rights agent as of or prior to the date and time of the irrevocable acceptance for payment by Purchaser of the Shares that have been validly tendered and not validly withdrawn pursuant to and subject to the conditions of the Offer. The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase and in the related Letter of Transmittal, copies of which are attached hereto as Exhibits (a)(1)(A) and (a)(1)(B), respectively.
    All information contained in the Offer to Purchase (including Schedule I to the Offer to Purchase) and the accompanying Letter of Transmittal is hereby expressly incorporated herein by reference in response to Items 1 through 9 and Item 11 of this Schedule TO.
    The Agreement and Plan of Merger, dated as of April 29, 2025 (as it may be amended, supplemented or otherwise modified from time to time, the “Merger Agreement”), by and among Regulus, Parent and Purchaser, a copy of which is attached as Exhibit (d)(1) hereto, is incorporated herein by reference with respect to Items 4, 5, 6 and 11 of this Schedule TO.
    Item 1.   Summary Term Sheet.
    The information set forth in the “Summary Term Sheet” of the Offer to Purchase is incorporated herein by reference.
    Item 2.   Subject Company Information.
    (a)   The name of the subject company and the issuer of the securities to which this Schedule TO relates is Regulus Therapeutics Inc., a Delaware corporation. Regulus’ principal executive offices are located at 4224 Campus Point Court, Suite 210, San Diego, California 92121. Regulus’ telephone number is (858) 202-6300.
    (b)   This Schedule TO relates to the outstanding Shares. Regulus has advised Purchaser and Parent that, as of May 22, 2025 (the most recent practicable date): (i) 75,611,212 Shares were issued and outstanding, (ii) 20,680,159 Shares were subject to outstanding Regulus stock options, (iii) 500,000 Shares were issuable upon vesting of outstanding Regulus restricted stock units, (iv) 645,750 Shares were issuable upon vesting of outstanding Regulus performance stock units, (v) 28,030,459 Shares were issuable upon the conversion of outstanding shares of Regulus convertible preferred stock, and (vi) warrants to purchase an aggregate of 993,367 Shares were outstanding.
    (c)   The information set forth in Section 6 — “Price Range of Shares; Dividends on the Shares; Effect of the Offer on the Market for Shares” of the Offer to Purchase is incorporated herein by reference.
    Item 3.   Identity and Background of the Filing Person.
    (a) – (c) This Schedule TO is filed by Purchaser and Parent. The information set forth in Section 8 — “Certain Information Concerning Parent and Purchaser” of the Offer to Purchase and Schedule I to the Offer to Purchase is incorporated herein by reference.
     
    1

    ​
     
    Item 4.   Terms of the Transaction.
    (a)(1)(i) – (viii), (xii), (a)(2)(i) – (iv), (vii) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    the “Introduction”
    ​
    •
    the “Summary Term Sheet”
    ​
    •
    Section 1 — “Terms of the Offer”
    ​
    •
    Section 2 — “Acceptance for Payment and Payment for Shares”
    ​
    •
    Section 3 — “Procedures for Accepting the Offer and Tendering Shares”
    ​
    •
    Section 4 — “Withdrawal Rights”
    ​
    •
    Section 5 — “Material U.S. Federal Income Tax Consequences”
    ​
    •
    Section 10 — “Background of the Offer and the Merger; Past Contacts or Negotiations with the Company”
    ​
    •
    Section 11 — “The Merger Agreement; The CVR Agreement”
    ​
    •
    Section 12 — “Purpose of the Offer; Plans for Regulus”
    ​
    •
    Section 13 — “Certain Effects of the Offer”
    ​
    •
    Section 15 — “Conditions of the Offer”
    ​
    •
    Section 16 — “Certain Legal Matters; Regulatory Approvals”
    ​
    •
    Section 17 — “Appraisal Rights”
    ​
    •
    Section 19 — “Miscellaneous”
    ​
    (a)(1)(ix) – (xi), (a)(2)(v) – (vi) Not applicable.
    Item 5.   Past Contacts, Transactions, Negotiations and Agreements.
    (a), (b)   The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    the “Introduction”
    ​
    •
    the “Summary Term Sheet”
    ​
    •
    Section 8 — “Certain Information Concerning Parent and Purchaser”
    ​
    •
    Section 10 — “Background of the Offer and the Merger; Past Contacts or Negotiations with the Company”
    ​
    •
    Section 11 — “The Merger Agreement; The CVR Agreement”
    ​
    •
    Section 12 — “Purpose of the Offer; Plans for Regulus”
    ​
    •
    Schedule I
    ​
    Item 6.   Purposes of the Transaction and Plans or Proposals.
    (a), (c)(1) – (7) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    the “Introduction”
    ​
    •
    the “Summary Term Sheet”
    ​
    •
    Section 6 — “Price Range of Shares; Dividends on the Shares; Effect of the Offer on the Market for Shares”
    ​
     
    2

    ​
     
    •
    Section 10 — “Background of the Offer and the Merger; Past Contacts or Negotiations with Regulus”
    ​
    •
    Section 11 — “The Merger Agreement; The CVR Agreement”
    ​
    •
    Section 12 — “Purpose of the Offer; Plans for Regulus”
    ​
    •
    Section 13 — “Certain Effects of the Offer”
    ​
    •
    Section 14 — “Dividends and Distributions”
    ​
    •
    Schedule I
    ​
    Item 7.   Source and Amount of Funds or Other Consideration.
    (a) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    the “Summary Term Sheet”
    ​
    •
    Section 9 — “Source and Amount of Funds”
    ​
    (b) and (d)  — Not applicable.
    Item 8.   Interest in Securities of the Subject Company.
    (a) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    the “Summary Term Sheet”
    ​
    •
    Section 8 — “Certain Information Concerning Parent and Purchaser”
    ​
    •
    Section 11 — “The Merger Agreement; The CVR Agreement”
    ​
    •
    Section 12 — “Purpose of the Offer; Plans for Regulus”
    ​
    •
    Schedule I
    ​
    (b) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    Section 8 — “Certain Information Concerning Parent and Purchaser”
    ​
    •
    Schedule I
    ​
    Item 9.   Persons/Assets, Retained, Employed, Compensated or Used.
    (a) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    the “Summary Term Sheet”
    ​
    •
    Section 3 — “Procedures for Accepting the Offer and Tendering Shares”
    ​
    •
    Section 10 — “Background of the Offer and the Merger; Past Contacts or Negotiations with Regulus”
    ​
    •
    Section 18 — “Fees and Expenses”
    ​
    Item 10.   Financial Statements.
    Not applicable.
    Item 11.   Additional Information.
    (a)(1) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    Section 8 — “Certain Information Concerning Parent and Purchaser”
    ​
     
    3

    ​
     
    •
    Section 10 — “Background of the Offer and the Merger; Past Contacts or Negotiations with Regulus”
    ​
    •
    Section 11 — “The Merger Agreement; The CVR Agreement”
    ​
    •
    Section 12 — “Purpose of the Offer; Plans for Regulus”
    ​
    (a)(2) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    Section 12 — “Purpose of the Offer; Plans for Regulus”
    ​
    •
    Section 15 — “Conditions of the Offer”
    ​
    •
    Section 16 — “Certain Legal Matters; Regulatory Approvals”
    ​
    (a)(3) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    Section 11 — “The Merger Agreement; The CVR Agreement”
    ​
    •
    Section 15 — “Conditions of the Offer”
    ​
    •
    Section 16 — “Certain Legal Matters; Regulatory Approvals”
    ​
    (a)(4) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    Section 6 — “Price Range of Shares; Dividends on the Shares; Effect of the Offer on the Market for Shares”
    ​
    (a)(5) The information set forth in the following sections of the Offer to Purchase is incorporated herein by reference:
    •
    Section 16 — “Certain Legal Matters; Regulatory Approvals”
    ​
    (c) The information set forth in the Offer to Purchase is incorporated herein by reference.
    Item 12.   Exhibits.
    ​
    Exhibit No.
    ​ ​
    Description
    ​
    ​ (a)(1)(A) ​ ​
    Offer to Purchase, dated May 27, 2025.*
    ​
    ​ (a)(1)(B) ​ ​
    Form of Letter of Transmittal (including Guidelines for Certification of Taxpayer Identification Number on IRS Form W-9).*
    ​
    ​ (a)(1)(C) ​ ​
    Form of Letter to Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees.*
    ​
    ​ (a)(1)(D) ​ ​
    Form of Letter to Clients for use by Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees.*
    ​
    ​ (a)(1)(E) ​ ​
    Form of Notice of Guaranteed Delivery.*
    ​
    ​ (a)(1)(F) ​ ​
    Summary Advertisement, dated May 27, 2025.*
    ​
    ​ (a)(1)(G) ​ ​
    Power of Attorney for Novartis AG, dated April 24, 2025.*
    ​
    ​ (a)(1)(H) ​ ​
    Power of Attorney for Redwood Merger Sub Inc., dated May 20, 2025.*
    ​
    ​ (a)(5)(A) ​ ​
    Press release issued by Novartis AG, dated April 30, 2025 (incorporated by reference to Exhibit 99.1 to the Schedule TO-C filed by Novartis AG with the SEC on April 30, 2025).
    ​
    ​ (a)(5)(B) ​ ​ LinkedIn post from Aharon (Ronny) Gal, Ph.D., Chief Strategy & Growth Officer of Novartis AG, dated April 30, 2025 (incorporated by reference to Exhibit 99.2 to the Schedule TO-C filed by Novartis AG with the SEC on April 30, 2025). ​
    ​ (a)(5)(C) ​ ​
    Novartis AG employee intranet post, dated April 30, 2025 (incorporated by reference to Exhibit 99.3 to the Schedule TO-C filed by Novartis AG with the SEC on April 30, 2025).
    ​
     
    4

    ​
     
    ​
    Exhibit No.
    ​ ​
    Description
    ​
    ​ (a)(5)(D) ​ ​ Email message dated May 1, 2025, from Dr. Ruchira Glaser, Development Unit Head, Cardiovascular, Renal and Metabolic at Novartis AG, to the Regulus employees (incorporated by reference to Exhibit 99.1 to the Schedule TO-C filed by Novartis AG with the SEC on May 1, 2025). ​
    ​ (b) ​ ​ Not applicable. ​
    ​ (d)(1) ​ ​ Agreement and Plan of Merger, dated as of April 29, 2025, among Regulus Therapeutics Inc., Novartis AG and Redwood Merger Sub Inc. (incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K filed by Regulus Therapeutics Inc. on April 30, 2025).** ​
    ​ (d)(2) ​ ​ Form of Contingent Value Rights Agreement (incorporated by reference to Annex D of Exhibit 2.1 to the Current Report on Form 8-K filed by Regulus Therapeutics Inc. on April 30, 2025). ​
    ​ (g) ​ ​ Not applicable. ​
    ​ (h) ​ ​ Not applicable. ​
    ​ 107 ​ ​
    Filing Fee Table.*
    ​
    ​
    *
    Filed herewith.
    ​
    **
    Certain exhibits and schedules have been omitted pursuant to Instruction 1 to Item 1016 of Regulation M-A. Parent hereby undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC.
    ​
    Item 13.   Information Required by Schedule 13E-3.
    Not applicable.
     
    5

    ​
     
    SIGNATURES
    After due inquiry and to the best knowledge and belief of the undersigned, each of the undersigned certifies that the information set forth in this statement is true, complete and correct.
    Redwood Merger Sub Inc.
    By:
    /s/ Jaime Huertas
    ​
    ​
    Name: Jaime Huertas
    Title:  Secretary
    Novartis AG
    By:
    /s/ David Quartner
    ​
    ​
    Name: David Quartner
    Title:   As Attorney
    By:
    /s/ Tariq El Rafie
    ​
    ​
    Name: Tariq El Rafie
    Title:   As Attorney
    Date: May 27, 2025
     
    6

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    SAN DIEGO, June 23, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced Preston S. Klassen, M.D., President and Head of Research & Development, has been appointed to the Company's Board of Directors. "We are delighted to have Dr. Klassen join our board during this exciting time for Regulus, as we advance the clinical development of RGLS8429 for the treatment of ADPKD," said Stelios Papadopoulos, Ph.D., Chairman

    6/23/23 8:00:00 AM ET
    $RGLS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Regulus Therapeutics Strengthens Research & Development Leadership

    Appoints Preston S. Klassen, M.D., as President and Head of Research & Development Curtis A. Monnig, Ph.D., named Vice President of CMC SAN DIEGO, June 12, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced the appointment of Preston S. Klassen M.D., M.H.S., to President and Head of Research and Development. Dr. Klassen brings over 20 years of experience in leadership roles in both large and small biopharmaceutical companies. In addition, the Company announced the appointment of Curtis A. Monnig, Ph.D., to Vice President of

    6/12/23 7:59:58 AM ET
    $RGLS
    Biotechnology: Pharmaceutical Preparations
    Health Care

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    Regulus Therapeutics Announces Positive Clinical and Regulatory Updates from its Autosomal Dominant Polycystic Kidney Disease (ADPKD) Program for Farabursen (RGLS8429)

    Topline data from an interim analysis of the fourth cohort of its Phase 1b Multiple-Ascending Dose (MAD) clinical trial showed continued mechanistic dose response Exploratory results of imaging-based biomarkers continued to show reduction in height-adjusted total kidney volume (htTKV) growth rate Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement on key components of a Phase 3 single pivotal trial for potential Accelerated Approval Company to hold conference call at 8:30 a.m. ET today SAN DIEGO, Jan. 29, 2025 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovati

    1/29/25 7:00:00 AM ET
    $RGLS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Regulus Therapeutics Announces Positive Topline Data from the Third Cohort of Patients in its Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

    Continued mechanistic dose response observed following completion of 3 mg/kg dose level based on urinary biomarker analyses Percent change from baseline in PC1 and PC2 demonstrated a dose response across all doses tested, with statistical significance seen at 3 mg/kg compared to placebo Exploratory imaging analyses indicated reduction in total kidney volume in 70% of patients dosed with 3 mg/kg  Fourth cohort enrollment underway  Company to hold conference call at 8:30am ET today SAN DIEGO, June 24, 2024 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "R

    6/24/24 7:00:00 AM ET
    $RGLS
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Regulus Therapeutics Announces Positive Topline Data from the Second Cohort of Patients in its Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

    Mechanistic dose response observed at a 2mg/kg dose level based on urinary biomarker analyses Encouraging exploratory results of imaging-based biomarkers with greatest reductions in total kidney volume seen in patients with the highest increases in PC1 and PC2 Cohort 3 fully enrolled with data readout anticipated in mid-2024; Cohort 4 screening to start in 2Q 2024 Company to hold conference call at 8:30am ET today SAN DIEGO, March 12, 2024 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced positive topline results from the second

    3/12/24 6:30:00 AM ET
    $RGLS
    Biotechnology: Pharmaceutical Preparations
    Health Care