Form SC TO-T/A - Tender offer statement by Third Party: [Amend]

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE TO

(Rule 14d-100)

TENDER OFFER STATEMENT UNDER SECTION 14(D)(1) OR 13(E)(1) OF
THE SECURITIES EXCHANGE ACT OF 1934

(Amendment No. 4)

ICOSAVAX, INC.

(Name of Subject Company (Issuer))

ISOCHRONE MERGER SUB INC.

a wholly owned subsidiary of

ASTRAZENECA FINANCE AND HOLDINGS INC.

a wholly owned subsidiary of

ASTRAZENECA PLC

(Names of Filing Persons — Offerors)

Common Stock, par value $0.0001 per share

(Title of Class of Securities)

45114M 109

(CUSIP Number of Class of Securities (Underlying Common Stock))

Adrian Kemp
AstraZeneca PLC

1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA

England
Telephone: +44 20 3749 5000

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)

Copies to:

Sebastian L. Fain, Esq.

Freshfields Bruckhaus Deringer US LLP
175 Greenwich Street, 51st Floor
New York, NY 10007-2759

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 Amendment No. 4 (this “Amendment”) amends and supplements the Tender Offer Statement on Schedule TO filed with the Securities and Exchange Commission (the “SEC”) on December 27, 2023 and amended on January 11, 2024, January 19, 2024 and February 15, 2024 (together with any amendments and supplements hereto, the “Schedule TO”) by AstraZeneca PLC, a public limited company incorporated in England and Wales (“AstraZeneca”), AstraZeneca Finance and Holdings Inc., a Delaware corporation and wholly owned subsidiary of AstraZeneca (“Parent”), and Isochrone Merger Sub Inc., a Delaware corporation and wholly owned subsidiary of Parent (“Merger Sub”). The Schedule TO relates to the tender offer by Merger Sub to purchase all of the outstanding shares of common stock, par value $0.0001 per share (the “Shares”), of Icosavax, Inc., a Delaware corporation (the “Company”), for (i) $15.00 per Share in cash, subject to applicable withholding taxes and without interest (the “Closing Amount”), plus (ii) one non-transferable contingent value right (each, a “CVR”) per Share representing the right to receive a contingent payment of up to $5.00 in cash, subject to applicable withholding taxes and without interest, upon the achievement of specified milestones on or prior to the applicable outside date pursuant to the terms and subject to the other conditions set forth in the Contingent Value Rights Agreement (the Closing Amount plus one CVR, collectively, or any greater amount per Share that may be paid pursuant to the Offer (as defined below), the “Offer Price”), in each case, 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 to the Schedule TO as Exhibits (a)(1)(A) and (a)(1)(B), respectively, and which, together, as they may be amended, supplemented or otherwise modified from time to time, collectively constitute the “Offer”.

All information regarding the Offer as set forth in the Schedule TO, including all exhibits thereto that were previously filed with the Schedule TO, is hereby expressly incorporated by reference into this Amendment, except that such information is hereby amended and supplemented to the extent specifically provided for herein. Capitalized terms used but not defined in this Amendment have the meanings ascribed to them in the Schedule TO.

Items 1 through 9 and Item 11.

The Offer to Purchase and Items 1 through 9 and Item 11 of the Schedule TO, to the extent such Items incorporate by reference the information contained in the Offer to Purchase, are hereby amended and supplemented as follows:

“The Offer and related withdrawal rights expired as scheduled at one minute after 11:59 p.m., New York City time, on February 16, 2024 (such date and time, the “Expiration Time”), and the Offer was not extended. Merger Sub was advised by the Depositary, that, as of the Expiration Time, a total of 35,912,932 Shares had been validly tendered and not validly withdrawn pursuant to the Offer, representing approximately 70.7% of the outstanding Shares as of the Expiration Time. As of the Expiration Time, the number of Shares validly tendered and not validly withdrawn pursuant to the Offer satisfied the Minimum Condition, and all other Offer Conditions were satisfied. Promptly after the expiration of the Offer, Merger Sub accepted all Shares validly tendered and not validly withdrawn pursuant to the Offer and will promptly pay for all Shares accepted pursuant to the Offer.

Parent completed the acquisition of the Company on February 19, 2024, by consummating the Merger pursuant to the Merger Agreement without a vote of the Company stockholders in accordance with Section 251(h) of the DGCL. At the Effective Time, Merger Sub was merged with and into the Company, the separate existence of Merger Sub ceased and the Company continued as the Surviving Corporation and a wholly owned subsidiary of Parent. Each Share issued and outstanding immediately prior to the Effective Time (excluding Shares owned by Parent, Merger Sub or the Company, or by any direct or indirect wholly owned subsidiary of Parent or Merger Sub, any Shares irrevocably accepted for payment pursuant to the Offer, and any Shares held by stockholders who are entitled to demand, and who shall have properly and validly demanded their statutory rights of appraisal in respect of such Shares in compliance with Section 262 of the DGCL), was canceled and extinguished and automatically converted into the right to receive the Merger Consideration, without interest thereon and subject to any applicable withholding tax.

Following the consummation of the Merger, the Shares will be delisted from The Nasdaq Global Select Market, and trading of Shares is expected to be suspended effective prior to the open of trading on February 20, 2024. Parent and Merger Sub intend to take steps to cause the termination of the registration of the Shares under the Exchange Act and suspend all of the Company’s reporting obligations under the Exchange Act as promptly as practicable.

On February 19, 2024, AstraZeneca issued a press release announcing the expiration and results of the Offer and the completion of the acquisition of the Company. The full text of the press release is attached as Exhibit (a)(5)(H) hereto and is incorporated herein by reference.”

ITEM 12. EXHIBITS.

Item 12 of the Schedule TO is hereby amended and supplemented by adding the following Exhibit to the list of Exhibits:

Index No.

(a)(5)(H)*		Press Release issued by AstraZeneca PLC, dated February 19, 2024.

*	Filed herewith.

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.

Date: February 20, 2024

	ASTRAZENECA PLC

	By:	/s/ Adrian Kemp
		Name:	Adrian Kemp
		Title:	Company Secretary

	ASTRAZENECA FINANCE AND HOLDINGS INC.

	By:	/s/ David E. White
		Name:	David E. White
		Title:	President & Treasurer

	ISOCHRONE MERGER SUB INC.

	By:	/s/ David E. White
		Name:	David E. White
		Title:	President & Treasurer

Exhibit (a)(5)(H)

19 February 2024

Acquisition of Icosavax Completed

AstraZeneca announced today the successful completion of the acquisition of Icosavax, Inc., a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform. As a result of the acquisition, Icosavax has become a subsidiary of AstraZeneca, with operations in Seattle, US.

The acquisition will build on AstraZeneca’s expertise in respiratory syncytial virus (RSV), strengthening AstraZeneca’s Vaccines & Immune Therapies late-stage pipeline with Icosavax’s lead investigational vaccine candidate, IVX-A12. IVX-A12 is a potential first-in-class, Phase III-ready, combination protein VLP vaccine which targets both RSV and human metapneumovirus (hMPV), two leading causes of severe respiratory infections and hospitalisations in adults 60 years of age and older and those with chronic conditions such as cardiovascular, renal and respiratory disease.^1-3

The acquisition was completed through a tender offer to purchase all outstanding shares of Icosavax for a price of $15.00 per share in cash up front, plus a non-tradable contingent value right for up to $5.00 per share in cash, payable upon achievement of a specified regulatory milestone and a specified sales milestone, which was followed by a statutory merger through which all shares of Icosavax stock that had not been validly tendered were converted into the right to receive the same consideration.

Combined, the upfront and contingent value rights payments, if achieved, represent a transaction value of approximately $1.1bn. As of the expiration of the tender offer, 35,912,932 shares of Icosavax were validly tendered and not validly withdrawn from the tender offer, representing approximately 70.7% of the outstanding shares of common stock of Icosavax, and such shares have been accepted for payment and will be paid for promptly in accordance with the terms of the tender offer. Icosavax shares will be delisted from the Nasdaq Stock Market, and Icosavax will terminate its registration under the U.S. Securities Exchange Act of 1934.

Forward-looking statements

This announcement may include statements that are not statements of historical fact, or “forward-looking statements,” including with respect to AstraZeneca’s acquisition of Icosavax. Such forward-looking statements include, but are not limited to, AstraZeneca’s beliefs and expectations and statements about the benefits sought to be achieved in AstraZeneca’s acquisition of Icosavax, the potential effects of the acquisition on AstraZeneca, as well as the expected benefits and success of IVX-A12 and any combination product. These statements are based upon the current beliefs and expectations of AstraZeneca’s management and are subject to significant risks and uncertainties. There can be no guarantees that IVX-A12 or any further vaccines using the VLP technology will receive the necessary regulatory approvals or prove to be commercially successful if approved. If underlying assumptions prove inaccurate or risks or uncertainties materialise, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, the possibility that the achievement of the specified milestones described in the contingent value rights agreement may take longer to achieve than expected or may never be achieved and the resulting contingent milestone payments may never be realised; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of COVID-19; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; competition from other products; and challenges inherent in new product development, including obtaining regulatory approval.

AstraZeneca undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in AstraZeneca’s Annual Reports on Form 20-F for the years ended 31 December 2022 and 31 December 2023, Icosavax’s Annual Report on Form 10-K for the year ended 31 December 2022 and Icosavax’s Quarterly Reports on Form 10-Q for the three months ended 31 March 2023, 30 June 2023 and 30 September 2023, in each case as amended by any subsequent filings made with the SEC. These and other filings made by AstraZeneca and Icosavax with the SEC are available at www.sec.gov.

Notes

RSV and hMPV in older adults

RSV is a common, contagious virus that is a major cause of lower respiratory tract infection in adults.⁴ Most adult RSV disease cases occur among older adults, with an estimated 60,000-160,000 hospitalisations and 6,000-10,000 deaths annually among US adults >65 years of age.⁵ RSV infection can cause serious complications such as pneumonia or exacerbation of congestive heart failure, asthma, and chronic obstructive pulmonary disease.⁴

hMPV causes disease very similar to RSV, including upper and lower respiratory tract infections that can be more severe in young children, older adults, and people with weakened immune systems.⁶ Adults with hMPV infection may have viral pneumonia, worsening asthma, or COPD symptoms.⁷ Data support similar morbidity and mortality for hMPV and RSV.² There are currently no treatment or preventative therapies for hMPV and no combination vaccines for RSV.^4,8

IVX-A12

IVX-A12 is the most advanced investigational vaccine targeting both RSV and hMPV and has a differentiated profile versus currently approved RSV vaccines. Phase II data demonstrate that IVX-A12 elicits robust immune responses against both RSV and hMPV one month after vaccination and reconfirm previous immunogenicity data seen in the Phase I trial.⁹ The data are the first to demonstrate hMPV immune response in a Phase II combination vaccine trial.⁹ IVX-A12 was generally well-tolerated in the trial, with a safety profile similar to that seen in the Phase I trial.⁹

IVX-A12 is a liquid, refrigerator-stable formulation comprised of IVX-121, Icosavax’s RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax’s hMPV prefusion F protein VLP vaccine candidate.

IVX-A12 has been granted Fast Track Designation from the US Food and Drug Administration, a programme designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need.¹⁰

VLP technology

VLPs are a proven technology with multiple products on the market, including vaccines for human papillomavirus and hepatitis B.¹¹ While currently available vaccines utilise the few proteins that naturally fold into VLPs,¹² the protein VLP platform builds on that success with intentionally designed VLPs to create highly differentiated vaccines.

VLPs are designed to resemble the structure of viruses, with high-density display of antigens.^10,11 This technology is believed to induce a stronger and more durable immune response versus traditional soluble antigens.^10,11

Through its ability to more effectively present antigens to the immune system, the VLP platform offers the ability to further innovate and bring next-generation respiratory combination vaccines to market.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

Contacts

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References

Sieling WD, Goldman CR, et al. Comparative incidence and burden of respiratory viruses associated with hospitalization in adults in New York City. Influenza Resp Viruses. 2021;15(5):670-677. doi:10.1111/irv.12842

Widmer K, Zhu Y, et al. Rates of hospitalizations for respiratory syncytial virus, human metapneumovirus, and influenza virus in older adults. J Infect Dis. 2012;206(1):56-62. doi:10.1093/infdis/jis309

Jain S, Self WH, et al. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. N Engl J Med. 2015 Jul 30;373(5):415-27.

RSV in Older Adults and Adults with Chronic Medical Conditions. CDC. Published 7 November 2023. Accessed 15 February 2024. https://www.cdc.gov/rsv/high-risk/older-adults.html.

Havers FP, Whitaker M, et al. Characteristics and Outcomes Among Adults Aged ≥60 Years Hospitalized with Laboratory-Confirmed Respiratory Syncytial Virus - RSV-NET, 12 States, July 2022-June 2023. MMWR Morb Mortal Wkly Rep. 2023 Oct 6;72(40):1075-1082.

Human metapneumovirus. CDC. Published 20 September 2023. Accessed 15 February 2024 https://www.cdc.gov/ncird/human-metapneumovirus.html

Esposito S, Mastrolia MV. Metapneumovirus Infections and Respiratory Complications. Semin Respir Crit Care Med. 2016 Aug;37(4):512-21.

RSV Vaccination for Older Adults 60 Years of Age and Over. CDC. Published 30 August 2023. Accessed 15 February 2024. https://www.cdc.gov/vaccines/vpd/rsv/public/older-adults.html

Icosavax [press release]. Icosavax Announces Positive Topline Interim Phase 2 Results for Combination VLP Vaccine Candidate IVX-A12 Against RSV and hMPV in Older Adults. 12 December 2023. Accessed 15 February 2024. https://ir.icosavax.com/news-releases/news-release-details/icosavax-announces-positive-topline-interim-phase-2-results.

10.

Icosavax [press release]. Icosavax Granted FDA Fast Track Designation for IVX-A12. 21 February 2023. Accessed 15 February 2024. https://ir.icosavax.com/news-releases/news-release-details/icosavax-granted-fda-fast-track-designation-ivx-a12.

11.

Tariq H, Batool S, et al. Virus-like particles: revolutionary platforms for developing vaccines against emerging infectious diseases. Front Microbiol. 2022; Jan 3;12:790121.

12.

Nooraei, S, Bahrulolum H, et al. Virus-like particles: preparation, immunogenicity and their roles as nanovaccines and drug nanocarriers. J Nanobiotechnol. 2021;19(59).

Adrian Kemp

Company Secretary
AstraZeneca PLC