# EDGAR Filing Document

**Accession Number:** 0001114448
**File Stem:** 0001104659-25-061301
**Filing Date:** 2025-6
**Character Count:** 18898
**Document Hash:** 7146f9478a536274ee54dbd47542d1dd
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-061301.hdr.sgml**: 20250623

**ACCESSION NUMBER**: 0001104659-25-061301

**CONFORMED SUBMISSION TYPE**: SC TO-T/A

**PUBLIC DOCUMENT COUNT**: 4

**FILED AS OF DATE**: 20250623

**DATE AS OF CHANGE**: 20250623

**GROUP MEMBERS**: REDWOOD MERGER SUB INC

**SUBJECT COMPANY**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Regulus Therapeutics Inc.
- **CENTRAL INDEX KEY:** 0001505512
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 264738379
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** SC TO-T/A
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 005-87002
- **FILM NUMBER:** 251062846

**BUSINESS ADDRESS:**
- **STREET 1:** 4224 CAMPUS POINT COURT
- **STREET 2:** SUITE 210
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** 858-202-6300

**MAIL ADDRESS:**
- **STREET 1:** 4224 CAMPUS POINT COURT
- **STREET 2:** SUITE 210
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
**FILED BY**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NOVARTIS AG
- **CENTRAL INDEX KEY:** 0001114448
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** V8
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** SC TO-T/A

**BUSINESS ADDRESS:**
- **STREET 1:** LICHTSTRASSE 35
- **CITY:** BASEL
- **STATE:** V8
- **ZIP:** CH 4056
- **BUSINESS PHONE:** 01141613241111

**MAIL ADDRESS:**
- **STREET 1:** LICHTSTRASSE 35
- **CITY:** BASEL
- **STATE:** V8
- **ZIP:** CH 4056

**UNITED STATES<br> SECURITIES AND EXCHANGE COMMISSION<br> Washington, D.C. 20549**

**SCHEDULE TO** **<br> TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1) <br> OF THE SECURITIES EXCHANGE ACT OF 1934**

**(Amendment No.** **2)**

**REGULUS THERAPEUTICS INC.** **<br> (Name of Subject Company (Issuer))**

**REDWOOD MERGER** **SUB INC.**

**(Offeror)** **<br> A Wholly Owned Subsidiary of**

**NOVARTIS AG**

**(Parent of Offeror)** **<br> (Names of Filing Persons (identifying status as offeror, issuer or other person))**

**Common Stock, par value $0.001 per share<br> (Title of Class of Securities)**

**75915K309** **<br> (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)**

***Copies to:*** **<br> 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 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 Amendment No. 2 to the Tender Offer Statement on Schedule TO (this "**Amendment**") amends and supplements the Tender Offer Statement on Schedule TO filed with the Securities and Exchange Commission on May 27, 2025 (as it may be amended and supplemented from time to time, the "**Schedule TO**") 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. The Schedule TO relates to the offer (the "**Offer**") to acquire all of the outstanding shares of common stock, par value $0.001 per share (the "**Shares**"), of Regulus Therapeutics Inc., a Delaware corporation (the "**Company**"), in exchange for (a) $7.00 in cash per Share, subject to any applicable withholding and without interest thereon, plus (b) 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 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, dated May 27, 2025 (as it may be amended or supplemented from time to time, the "**Offer to Purchase**"), and in the related Letter of Transmittal, copies of which are attached as Exhibits (a)(1)(A) and (a)(1)(B) to the Schedule TO, respectively.

This Amendment is being filed solely to amend and supplement items to the extent specifically provided herein. Except as otherwise set forth in this Amendment, the information set forth in the Schedule TO, including all exhibits thereto, remains unchanged and is incorporated herein by reference to the extent relevant to the items in this Amendment. This Amendment should be read together with the Schedule TO. Capitalized terms used but not defined herein have the meanings ascribed to them in the Schedule TO, as amended by this Amendment.

***Items 1 through 9 and Item 11.***

Items 1 through 9 and Item 11 of the Schedule TO are hereby amended and supplemented as follows:

The information set forth in Section 11 — "*The Merger Agreement; The CVR Agreement*" of the Offer to Purchase is hereby amended by adding the following sentence as the last sentence of the first paragraph under the section entitled "*The Merger Agreement — Antitrust Filings*" on page 52:

"Parent and the Company filed their respective Premerger Notification and Report Forms with the FTC and the Antitrust Division on May 20, 2025 and the waiting period under the HSR Act expired on June 20, 2025, at 11:59 p.m., Eastern Time."

The information set forth in Section 16 — "*Certain Legal Matters; Regulatory Approvals*" of the Offer to Purchase is hereby amended by deleting the second paragraph under the section entitled "— *Antitrust Approvals*" on page 70 in its entirety and replacing it with the following paragraph:

"The waiting period under the HSR Act expired on June 20, 2025, at 11:59 p.m., Eastern Time. Accordingly, the condition to the Offer requiring that any waiting period (and extensions thereof, including under any agreement between Parent, the Company or Purchaser and a governmental authority agreeing not to consummate the Merger prior to a certain date entered into in compliance with the Merger Agreement) applicable to the transactions contemplated by the Merger Agreement under the HSR Act will have expired or been terminated, has been satisfied. The Offer continues to be subject to the remaining conditions set forth in the Offer to Purchase. See Section 15 — "*Conditions to the Offer*.""

---

| | |
|:---|:---|
| ***Item 12.*** | ***Exhibits.*** |

---

Item 12 of the Schedule TO is hereby amended and supplemented by adding the following exhibit:

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [(a)(5)(E)](tm2516065d11_ex99-a5e.htm) | [Press Release issued by Novartis AG, dated June 23, 2025.](tm2516065d11_ex99-a5e.htm) |

---

**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.** | | |
|  | /s/ Jaime Huertas | /s/ Jaime Huertas |
|  | Name: | Jaime Huertas |
|  | Title: | Secretary |
| **Novartis AG** | | |
|  | /s/ Jonathan Emery | /s/ Jonathan Emery |
|  | Name: | Jonathan Emery |
|  | Title: | As Attorney |
|  | /s/ Tariq El Rafie | /s/ Tariq El Rafie |
|  | Name: | Tariq El Rafie |
|  | Title: | As Attorney |
| Date: June 23, 2025 | | |

---

## Ex-99.(A)(5)(E)

**Exhibit (a)(5)(E)**

![](tm2516065d11_ex99-a5eimg2.jpg)

---

| | |
|:---|:---|
| ![](tm2516065d11_ex99-a5eimg1.jpg)  | **Novartis International AG** |
| ![](tm2516065d11_ex99-a5eimg1.jpg)  | CH-4002 Basel |
| ![](tm2516065d11_ex99-a5eimg1.jpg)  | Switzerland |
| ![](tm2516065d11_ex99-a5eimg1.jpg)  |  |
| ![](tm2516065d11_ex99-a5eimg1.jpg)  | <u>https://www.novartis.com</u> |
| ![](tm2516065d11_ex99-a5eimg1.jpg)  | <u>http://x.com/NovartisNews</u> |

---

**PRESS RELEASE**

**Novartis announces expiration of HSR waiting period of Regulus Therapeutics tender offer**

**Basel, June 23, 2025** – Novartis today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), in connection with Novartis' previously announced tender offer to acquire all of the outstanding shares of common stock, par value $0.001 per share (the "Shares"), of Regulus Therapeutics Inc. ("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 a regulatory milestone. The expiration of the HSR Act waiting period occurred at 11:59 p.m., New York City Time, on June 20, 2025.

Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transactions contemplated by the Agreement and Plan of Merger, dated as of April 29, 2025 (the "Merger Agreement"), among Novartis, Redwood Merger Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Novartis ("Purchaser"), and Regulus, including the tender offer and the subsequent merger, which remain subject to the condition that there be validly tendered and not validly withdrawn, immediately prior to the Expiration Time (as defined below) a number of Shares that, together with any Shares then owned by Novartis, Purchaser or any of their direct or indirect wholly owned subsidiaries, represents at least one more Share than 50% of the total number of all the outstanding Shares immediately prior to the Expiration Time. The offer will expire one minute past 11:59 p.m., New York City Time, on June 24, 2025, unless the tender offer is otherwise extended or earlier terminated (such time, the "Expiration Time").

**Additional Information**

This press release is neither an offer to purchase nor a solicitation of an offer to sell any Shares or any other securities. At the time the tender offer described in this press release was commenced, Novartis and Purchaser filed a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the U.S. Securities and Exchange Commission (the "SEC"), and Regulus filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC, in each case with respect to the tender offer.

**INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES.**

An offer to purchase the Shares is only being made pursuant to the offer to purchase, the letter of transmittal and related offer documents filed as a part of the Schedule TO. Those materials and all other documents filed by, or caused to be filed by, Novartis, Purchaser and Regulus with the SEC are available at no charge on the SEC's website at <u>www.sec.gov/</u> or by directing such requests to the information agent for the offer, which is named in the tender offer statement. The offer to purchase and related materials also may be obtained for free under the "Investors – Financial Data" section of Novartis website at <u>www.novartis.com/investors/financial-data/sec-filings</u>. The solicitation/recommendation statement also may be obtained for free under the "Investors" section of Regulus' website at <u>ir.regulusrx.com/overview</u>. In addition, Regulus files annual, quarterly and current reports and other information, and Novartis files annual reports and other information with the SEC, which are also available to the public at no charge at www.sec.gov.

**Disclaimer**

This press release contains statements that are not statements of historical fact, or "forward-looking statements," including with respect to Novartis' proposed acquisition of Regulus. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for farabursen, regarding the proposed acquisition of Regulus and the expected timetable for completing the proposed acquisition, the benefits sought to be achieved in the proposed acquisition, or regarding potential future revenues from farabursen. You should not place undue reliance on these statements. Such forward-looking statements are based on Novartis' current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that farabursen clinical trials will be successful, that farabursen will be submitted for marketing approval or approved for sale or, if approved, receive approval for any additional indications or labeling, in any market, or at any particular time, nor can there be any guarantee that, if approved, farabursen will be commercially successful in the future. Neither can there be any guarantee that the conditions to the closing of the proposed acquisition will be satisfied on the expected timetable or at all or that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all. In particular, expectations regarding farabursen or the transaction described in this press release could be affected by, among other things, the timing of the offer and the satisfaction of customary closing conditions, including the tender of a majority of the outstanding Shares and the receipt of regulatory approvals on acceptable terms or at all; the risk that competing offers or acquisition proposals will be made; uncertainty as to whether the milestone associated with the CVR will be achieved and that holders of CVRs will receive payments in respect thereof; the effects of disruption from the transactions contemplated by the Merger Agreement and the impact of the announcement and pendency of the transactions on Novartis and/or Regulus' businesses, including their relationships with employees, business partners or governmental entities; the risk that the offer or the merger may be more expensive to complete than anticipated; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; a diversion of management's attention from ongoing business operations and opportunities as a result of the offer, the merger or otherwise; general industry conditions and competition; general political, economic and business conditions, including interest rate and currency exchange rate fluctuations; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's and Regulus' filings and reports with the SEC, including Novartis AG's Annual Report on Form 20-F for the year ended December 31, 2024, Regulus' Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Report on Form10-Q for the quarter ended March 31, 2025 and any subsequent filings made by either party with the SEC, available on the SEC's website at <u>www.sec.gov</u>. Novartis is providing the information in this press release as of this date and Novartis does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except to the extent required by law.

**About Novartis**

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at **https://www.novartis.com** and connect with us on **LinkedIn**, **Facebook**, **X/Twitter** and **Instagram**.

\# \# \#

---

| |
|:---|
| **Novartis Media Relations** <br> E-mail: media.relations@novartis.com |
| **Novartis Investor Relations** <br> Central investor relations line: +41 61 324 7944<br> E-mail: investor.relations@novartis.com |

---