Regulus Tender Offer Clears Antitrust Hurdle, Cash-and-CVR Deal Nears Completion

Rhea-AI Filing Summary

Novartis AG, through its wholly-owned subsidiary Redwood Merger Sub Inc., has filed Amendment No. 2 to its Schedule TO for the pending acquisition of Regulus Therapeutics Inc. (NASDAQ: RGLS). The tender offer terms remain unchanged at $7.00 in cash per share plus one contingent value right (CVR) that could deliver an additional $7.00 in cash upon achievement of a specified milestone.

The key update disclosed in this amendment is regulatory: the waiting period under the Hart-Scott-Rodino (HSR) Act expired on 20 June 2025 at 11:59 p.m. ET. With U.S. antitrust clearance now obtained, one of the principal conditions to closing has been satisfied. The offer, launched on 27 May 2025, remains subject to the other conditions detailed in the Offer to Purchase, including the minimum tender condition and customary closing requirements.

Item 12 adds Exhibit (a)(5)(E), a press release issued by Novartis on 23 June 2025 announcing the HSR status. No other economic terms, timelines, or financial metrics have been modified. Signatures from Novartis representatives and Redwood Merger Sub certify the accuracy of the filing.

• Transaction structure: all-cash tender offer followed by a merger; CVR provides additional upside.
• Regulatory status: HSR clearance achieved; remaining approvals not specified as material hurdles in this amendment.
• Next steps: shareholders may continue to tender shares; completion depends on remaining conditions outlined in Section 15 “Conditions to the Offer.”

Positive

• HSR waiting period expired on 20 June 2025, removing a key regulatory barrier to the Novartis–Regulus transaction.
• Offer economics preserved at $7.00 cash + $7.00 CVR, maintaining upside potential for shareholders.

Negative

• The CVR payment remains contingent on a milestone not detailed in this amendment, introducing outcome risk.
• Other offer conditions (e.g., minimum tender) are still outstanding, so closing is not yet guaranteed.

Insights

M&A Specialist

TL;DR: HSR expiration eliminates major regulatory risk, materially increasing deal-completion probability.

The expiration of the HSR waiting period is typically the longest lead-time regulatory hurdle for a U.S. transaction. By confirming clearance without a second request, Novartis signals that antitrust authorities found no substantive competition issues. This substantially de-risks the deal timetable and reduces the likelihood of renegotiation.

With consideration of $7.00 cash plus a $7.00 CVR, shareholders now face primarily deal-specific closing conditions—most notably the minimum tender threshold. Because the amendment does not adjust the offer price or extend the offer, it implies Novartis’s confidence in swift completion. On balance, the filing is positive for Regulus holders and neutral for Novartis given its size.

Biotechnology Equity Analyst

TL;DR: Clearance boosts visibility to near-term liquidity event for Regulus investors; milestone CVR remains speculative.

Regulus shareholders gain immediate clarity that antitrust review will not delay the $7.00 cash payout. The CVR remains tied to a milestone whose parameters are not repeated in this amendment, so upside beyond the base price is still uncertain. However, regulatory clearance tends to catalyze arbitrage interest and narrow any deal-completion discount. The absence of new scientific, clinical, or milestone details means long-term value hinges on the CVR, but today’s filing is decisively positive for transaction certainty.

 

 

 

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

(Amendment No. 2)

 

REGULUS THERAPEUTICS INC.
(Name of Subject Company (Issuer))

 

REDWOOD MERGER SUB INC.

(Offeror)
A Wholly Owned Subsidiary of

 

NOVARTIS AG

(Parent of Offeror)
(Names 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)

 

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:

 

þ      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)	Press Release issued by Novartis AG, dated June 23, 2025.

 

 

 

 

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

 

 

 

FAQ

What is the cash consideration Novartis is offering for RGLS shares?

Novartis is offering $7.00 in cash per share, subject to applicable withholding and without interest.

Does the deal include additional upside for Regulus shareholders?

Yes. Shareholders will also receive one CVR worth up to $7.00 in cash if a specified milestone is achieved.

Has the transaction received antitrust clearance?

Yes. The HSR waiting period expired on 20 June 2025, satisfying the U.S. antitrust approval condition.

What conditions remain before the tender offer closes?

The offer is still subject to remaining conditions in Section 15, including the minimum tender condition.

Where can investors find the full terms of the offer?

The terms are outlined in the Offer to Purchase dated 27 May 2025 and related documents filed with the SEC.