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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 26, 2023
AYALA
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-36138 |
|
02-0563870 |
(State
or other jurisdiction |
|
(Commission |
|
(IRS
Employer |
of
incorporation) |
|
File
Number) |
|
Identification
No.) |
9
Deer Park Drive, Suite K-1
Monmouth
Junction, NJ |
|
08852 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (609) 452-9813
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act: None
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into a Material Definitive Agreement.
Agreement
and Plan of Merger and Reorganization
On
July 26, 2023, Ayala Pharmaceuticals, Inc., a Delaware corporation (the “Company”), Advaxis Israel Ltd., a company organized
under the laws of the State of Israel and a wholly owned subsidiary of the Company (“Merger Sub”) and Biosight, Ltd., a company
organized under the laws of the State of Israel (“Biosight”) entered into an Agreement and Plan of Merger and Reorganization
(the “Merger Agreement”).
The
Merger Agreement provides, among other things, that on the terms and subject to the conditions set forth therein: (i) Merger Sub will
merge with and into Biosight, with Biosight being the surviving entity as a wholly-owned subsidiary of the Company (the “Merger”
and collectively with the other transactions contemplated by the Merger Agreement, the “Transactions”), (ii) each share of
Biosight issued and outstanding immediately prior to the effective time of the Merger (excluding any shares held by any of Biosight’s
subsidiaries, Parent, Merger Sub or any of their respective subsidiaries, which will remain outstanding, and certain dormant shares under
Israeli law, which will be cancelled, retired and cease to exist) will automatically be deemed to have been transferred to the Company
in exchange for the right to receive 1.82285 shares (the “Exchange Ratio”) of common stock, par value $0.001 per share (the
“Common Stock”) of the Company. The Exchange Ratio is subject to equitable adjustment pursuant to the terms of the Merger
Agreement. Each outstanding option or other right to purchase ordinary or preferred shares of Biosight will be cancelled as of the Effective
Time and will have no further force or effect. At the Closing (as defined below), shares of Parent Common Stock constituting 10% of the
aggregate Merger Consideration (as defined in the Merger Agreement) shall be deposited in escrow to support an indemnification obligation
of Biosight pursuant to the Merger Agreement.
Conditions
to Closing
Under
the Merger Agreement, the consummation of the Merger (the “Closing”) is subject to, and will take place within two business
days of, the satisfaction or waiver of certain customary closing conditions, including, without limitation: (i) Biosight must have obtained
the approval of its stockholders of the Merger and the Transactions contemplated by the Merger Agreement (the “Biosight Stockholder
Approval”), (ii) any waiting period applicable to the Merger under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, must have been terminated or expired, (iii) Biosight obtaining certain tax rulings under Israeli law and (iv) the receipt by
the Company of waivers from certain Biosight option holders and holders of Series C preferred shares.
Representations
and Warranties
The
parties to the Merger Agreement have agreed to customary representations and warranties for transactions of this type. In addition, the
parties to the Merger Agreement agreed to be bound by certain customary covenants for transactions of this type, including, among others,
covenants with respect to the conduct of the business and operations of the Company, Biosight and their respective subsidiaries during
the period between execution of the Merger Agreement and the Closing.
The
representations, warranties, agreements and covenants of the parties set forth in the Merger Agreement will terminate at the Closing.
Termination
and Termination Fees
The
Merger Agreement may be terminated under certain customary and limited circumstances at any time prior to the Closing, including without
limitation: (i) by mutual written consent of the Company and Biosight; (ii) by either the Company or Biosight, if (a) the Closing has
not occurred on or before January 22, 2024, (b) if a governmental authority shall have issued a final and non-appealable permanent restraining
order, permanent injunction or other similar permanent order which has the effect of making the Merger illegal or otherwise prohibiting
consummation of the Transactions, and (c) the Biosight Stockholder Approval has not been obtained at the Biosight stockholders meeting
(or any adjournments or postponements thereof), in each of (a), (b) and (c) where the terminating party’s failure to fulfill any
obligation under the Merger Agreement is not the primary cause of, or has directly resulted in, the failure of such condition; (iii)
by Biosight if (a) subject to certain conditions, the Company or Merger Sub breaches or fails to perform any of its representations,
warranties or covenants contained in the Merger Agreement and such breach or failure is not cured in accordance with the Merger Agreement
and would result in the failure of a condition to Closing under the Merger Agreement, (b) the board of directors of the Company (x) makes
a public recommendation in connection with a tender or exchange offer other than a recommendation against such tender or exchange offer
or (y) fails to recommend against any third-party acquisition proposal within ten business days after such acquisition proposal has been
publicly announced or disclosed, or (c) the Company has willfully breached the Merger Agreement; and (iv) by the Company if (a) subject
to certain conditions, Biosight breaches or fails to perform any of its representations, warranties or covenants contained in the Merger
Agreement and such breach or failure is not cured in accordance with the Merger Agreement and would result in a failure of a condition
to Closing under the Merger Agreement, (b) Biosight has willfully breached its non-solicitation covenant, (c) the Biosight board of directors
changes its recommendation to its stockholders to approve the Merger and related Transactions or (d) Biosight has willfully breached
the Merger Agreement. As further detailed in the Merger Agreement, each party is required to pay a termination fee in the amount of (x)
$1,000,000 or (y) $3,000,000, depending on the circumstance of the termination, in each case to the other party, upon the occurrence
of certain events that would impede or prevent the Closing, which are the responsibility of the paying party.
The
foregoing summary of the Merger Agreement does not purport to be complete and is qualified in its entirety be reference to the full copy
of the Merger Agreement, which is attached as Exhibit 2.1 to this Current Report on Form 8-K (the “Form 8-K”) and incorporated
into this Item 1.01 by reference.
Support
Agreements
In
connection with the Merger, certain shareholders of Biosight that are affiliated with the current directors of Biosight (each such Biosight
shareholder, a “Supporting Shareholder”), have each entered into a Support Agreement (each, a “Support Agreement”
and together, the “Support Agreements”), by and among the Company, Biosight and the applicable Supporting Shareholder. Pursuant
to the Support Agreements, the Supporting Shareholders have agreed, among other things, to vote any shares of Biosight held by such Supporting
Shareholder in favor of, and to adopt and approve, the Merger, the Merger Agreement and the related Transactions at any meeting of the
Biosight stockholders, as applicable (or any adjournment or postponement thereof) held to obtain the Biosight Stockholder Approval.
The
foregoing summary of the Support Agreements does not purport to be complete and is qualified in its entirety be reference to the full
copy of a form of the Support Agreement, which is attached as Exhibit 2.2 to this Form 8-K and incorporated into this Item 1.01 by reference.
Item 5.07 Submission of Matters to a Vote of Security Holders.
On
July 28, 2023, the Company held the Company’s 2023 annual meeting of stockholders
(the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders (i) elected seven directors to the Company’s
board of directors to hold office until the next annual meeting of stockholders and until their respective successors have been duly
elected and qualified, subject to their earlier resignation or removal; (ii) approved an advisory (non-binding) resolution regarding
the compensation of the Company’s executive officers; (iii) ratified the appointment of Kost, Forer, Gabbay & Kasierer, a Member
of EY Global, as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2023; and
(iv) approved an amendment to the Company’s 2015 Incentive Plan to increase the total number of shares authorized for issuance
thereunder by 2,900,000 shares to 2,981,248 shares, to increase certain other maximum number of awards that may be granted annually and
to change the name of the plan to reflect the Company’s recent corporate name change. The results of these votes, as certified
by the inspector of elections for the Annual Meeting, are set forth below.
Proposal
1. Election of seven members to the Company’s Board of Directors to hold office until the next annual meeting of stockholders and
until their respective successors have been duly elected and qualified, subject to their earlier resignation or removal.
Nominee | |
Votes For | | |
Votes Against | | |
Abstentions | | |
Broker
Non-Votes | |
| |
| | |
| | |
| | |
| |
Dr. David Sidransky | |
| 816,431 | | |
| 297,235 | | |
| 12,064 | | |
| 1,225,138 | |
Dr. Vered Bisker-Leib | |
| 1,044,805 | | |
| 56,607 | | |
| 24,318 | | |
| 1,225,138 | |
Roni A. Appel | |
| 1,049,429 | | |
| 64,571 | | |
| 11,730 | | |
| 1,225,138 | |
Kenneth Berlin | |
| 971,936 | | |
| 129,897 | | |
| 23,897 | | |
| 1,225,138 | |
Dr. Robert Spiegel | |
| 1,037,380 | | |
| 63,012 | | |
| 25,338 | | |
| 1,225,138 | |
Murray Goldberg | |
| 1,031,823 | | |
| 69,461 | | |
| 24,446 | | |
| 1,225,138 | |
Dr. Samir N. Khleif | |
| 1,044,071 | | |
| 56,096 | | |
| 25,563 | | |
| 1,225,138 | |
Proposal
2. Approval of an advisory (non-binding) resolution regarding the compensation of the Company’s executive officers.
Votes For | | |
Votes Against | | |
Abstentions | | |
Broker Non-Votes | |
795,482 | | |
| 304,581 | | |
| 25,667 | | |
| 1,225,138 | |
Proposal
3. Ratification of the appointment of Kost, Forer, Gabbay & Kasierer, a Member of EY Global, as the Company’s independent registered
public accounting firm for the fiscal year ending December 31, 2023.
Votes For | | |
Votes Against | | |
Abstentions | | |
Broker Non-Votes | |
2,239,170 | | |
| 64,501 | | |
| 47,197 | | |
| — | |
Proposal
4. Approval of an amendment to the Company’s 2015 Incentive Plan to increase the total number of shares authorized for issuance
thereunder by 2,900,000 shares to 2,981,248 shares, to increase certain other maximum number of awards that may be granted annually and
to change the name of the plan to reflect the Company’s recent corporate name change.
Votes For | | |
Votes Against | | |
Abstentions | | |
Broker Non-Votes | |
678,752 | | |
| 327,854 | | |
| 119,124 | | |
| 1,225,138 | |
Item 8.01 Other Events.
On
July 27, 2023, the Company issued a press release announcing entry into the Merger Agreement with Biosight. A copy of the press release
is attached hereto as Exhibit 99.1 and incorporated into this Item 1.01 by reference.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No. |
|
Description |
2.1 |
|
Agreement and Plan of Merger and Reorganization, by and among the Company, Merger Sub, and Biosight, dated as of July 26, 2023. |
2.2 |
|
Form of Support Agreement, dated as of July 26, 2023, by and between the Company, Biosight and each director and executive officer of Biosight. |
99.1 |
|
Press Release of the Company, dated July 27, 2023 |
104.1 |
|
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 hereunto duly authorized.
August
1, 2023 |
AYALA
PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/
Kenneth A. Berlin |
|
Name: |
Kenneth A. Berlin |
|
Title: |
President and Chief Executive Officer |
Exhibit 2.1
Exhibit 2.2
Exhibit
99.1
Ayala
Pharmaceuticals and Biosight Enter into Definitive Merger Agreement
Combined
company to operate as Ayala Pharmaceuticals, Inc.
Merger
to add a clinical stage oncology asset to Ayala’s portfolio with data anticipated in the first half of 2024
REHOVOT
and TEL AVIV, ISRAEL & MONMOUTH JUNCTION, N.J., July 27, 2023 — Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a publicly-traded
clinical-stage oncology company, and Biosight Ltd., a privately-held pharmaceutical company developing innovative therapeutics for hematological
malignancies and disorders, today announced they have entered into a definitive merger agreement pursuant to which Ayala will combine
with Biosight in an all-stock transaction. Upon completion of the merger, the combined company will operate under the name Ayala Pharmaceuticals,
Inc., and will continue to trade on the OTCQX under Ayala’s current ticker symbol (“ADXS”). Certain of the current
Biosight shareholders have agreed to support the proposed transaction.
The
combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, a once-daily, potent,
selective, oral gamma-secretase inhibitor (GSI) and Biosight’s Aspacytarabine (BST-236). AL102 is currently being evaluated in
the registrational RINGSIDE study in desmoid tumors. There are currently no FDA-approved therapies for the treatment of unresectable,
recurrent or progressive desmoid tumors. Data from the Phase 2 portion of RINGSIDE were presented at the recent American Society of Clinical
Oncology Annual Meeting demonstrating AL102’s activity against progressing desmoid tumors. These data showed 50% partial response
and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 in the 1.2 mg once daily arm, the dosing regimen
being tested in the ongoing Phase 3 study. The majority of the patients from Phase 2 have continued on study and are now in the open
label extension of the Phase 3 portion of RINGSIDE. Ayala expects to present updated data on these patients at a medical conference later
this year.
“The
addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies and provides us
with additional avenues towards key clinical catalysts,” said Ken Berlin, President and CEO of Ayala. “Along with the merger,
we have plans to strengthen our balance sheet and execute our clinical plans, with the goal of creating sustainable value for patients
and shareholders.”
Pini
Orbach, PhD, Chairman of Biosight, commented, “The Ayala team shares our commitment to bringing innovative treatments to cancer
patients in need and we are excited to enter into this merger. Leveraging the combined capabilities and resources of both organizations
will provide a truly unique opportunity to build a leading, publicly-traded oncology company with advanced and diverse clinical stage
assets. I would like to express my deepest appreciation to the entire Biosight team, and I am proud of their excellent work and dedication
in advancing aspacytarabine and our pipeline.”
About
the Merger
Under
the terms of the merger agreement, upon completion of the merger, ownership of the combined company will be split, with 55% ownership
going to Biosight stockholders and 45% going to Ayala stockholders. The merger agreement has been unanimously approved by the Board of
Directors of each company, by all directors entitled to vote. The transaction is expected to close prior to the end of the third quarter
of 2023, subject to regulatory and other conditions including approval of Biosight stockholders.
Management
and Organization
Effective
as of the closing of the merger, the combined company will be led by Ayala’s existing senior management team, with Ken Berlin serving
as President and CEO. Additionally, the Board of Directors is expected to consist of nine members, including four designated by Ayala
and four designated by Biosight, as well as Mr. Berlin.
Advisors
Morgan,
Lewis & Bockius LLP and Meitar are serving as legal counsel to Ayala. Goodwin Procter LLP and Horn & Co. Law Offices are serving
as legal counsel to Biosight.
About
Ayala Pharmaceuticals, Inc.
Ayala
Pharmaceuticals, Inc. is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics
for people living with rare tumors and aggressive cancers and is also developing proprietary Lm-based antigen delivery products
for patients suffering from more common cancers. The Company’s lead candidates under development are the oral gamma secretase inhibitor,
AL102, for desmoid tumors; ADXS-504, a Lm-based therapy for early-stage prostate cancer; and the intravenous gamma secretase inhibitor,
AL101, for adenoid cystic carcinoma. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 segment
of a pivotal study for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.
About
AL102
AL102
is an investigational small molecule gamma secretase inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2,
3 and 4, and is currently being evaluated in the Phase 2/3 RINGSIDE clinical studies in patients with progressing desmoid tumors. AL102
is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch
activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November
2017. AL102 was granted U.S. FDA Fast Track Designation for the treatment of desmoid tumors.
About
Biosight Ltd.
Biosight
is a private clinical stage biotech company developing innovative therapeutics for hematological malignancies and disorders. Biosight’s
lead product, aspacytarabine (BST-236), is an innovative proprietary anti-metabolite designed to address unmet medical needs by enabling
high-dose chemotherapy with reduced systemic toxicity. For additional information, please visit www.biosight-pharma.com.
About
Aspacytarabine (BST-236)
Aspacytarabine
(BST-236) is being developed to serve as a superior novel backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
therapy, either as a single agent or in combination with other therapies, including targeted therapy agents. Results from a recently
completed Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and impressive single-agent
activity. Additional studies are ongoing to evaluate aspacytarabine in combination with venetoclax as a first-line treatment of AML,
as well as a second line monotherapy for patients with relapsed or refractory MDS or AML. Aspacytarabine has been granted FDA Fast Track
Designation for first-line treatment of AML patients unfit for standard chemotherapy, and Orphan Drug designations from the FDA and EMA
in AML, as well as Orphan Drug designation in MDS from the FDA.
Contacts:
Ayala
Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com
Investors:
Tim
McCarthy
LifeSci Advisors, LLC
tim@lifesciadvisors.com
917-679-9282
Cautionary
Statement Regarding Forward-Looking Statements
This
communication relates to the proposed transaction pursuant to the Agreement and Plan of Merger and Reorganization dated as of July 26,
2023, by and among Ayala Pharmaceuticals, Inc.(“Ayala”), Advaxis Israel Ltd. and Biosight Ltd. (“Biosight”).
This communication includes express or implied forward-looking statements about the proposed transaction between Ayala and Biosight and
the operations of the combined company that involve a number of risks and uncertainties, including statements regarding the future conduct
of our studies and the potential efficacy and success of product candidates. Forward-looking statements generally include statements
that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,”
“should,” “would,” “expect,” “anticipate,” “plan,” “likely,”
“believe,” “estimate,” “project,” “intend,” and other similar expressions among others.
Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and
assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially
from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the
conditions to the closing of the proposed transaction are not satisfied, including the failure to timely or at all obtain stockholder
approval for the proposed transaction or the failure to timely or at all obtain any required regulatory clearances; uncertainties as
to the timing of the consummation of the proposed transaction and the ability of each of Ayala and Biosight to consummate the proposed
transaction; the ability of Ayala and Biosight to integrate their businesses successfully and to achieve anticipated synergies; the possibility
that other anticipated benefits of the proposed transaction will not be realized, including without limitation, anticipated revenues,
expenses, earnings and other financial results, and growth and expansion of the combined company’s operations, and the anticipated
tax treatment of the combination; potential litigation relating to the proposed transaction that could be instituted against Ayala, Biosight
or their respective directors; possible disruptions from the proposed transaction that could harm Ayala’s and/or Biosight’s
respective businesses; the ability of Ayala and Biosight to retain, attract and hire key personnel; potential adverse reactions or changes
to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the proposed
transaction; potential business uncertainty, including changes to existing business relationships, during the pendency of the proposed
transaction that could affect Ayala’s or Biosight’s financial performance; certain restrictions during the pendency of the
proposed transaction that may impact Ayala’s or Biosight’s ability to pursue certain business opportunities or strategic
transactions; the success and timing of clinical trials, including subject accrual, the ability to avoid and quickly resolve any clinical
holds and the ability to obtain and maintain regulatory approval and/or reimbursement of product candidates for marketing; the ability
to obtain the appropriate labeling of products under any regulatory approval; plans to develop and commercialize our products; our ability
to continue as a going concern; our levels of available cash and our need to raise additional capital, including to support current and
future planned clinical activities; the successful development and implementation of our sales and marketing campaigns; the size and
growth of the potential markets for our product candidates and our ability to serve those markets; our ability to successfully compete
in the potential markets for our product candidates, if commercialized; regulatory developments in the United States and other countries;
the rate and degree of market acceptance of any of our product candidates; new products, product candidates or new uses for existing
products or technologies introduced or announced by our competitors and the timing of these introductions or announcements; market conditions
in the pharmaceutical and biotechnology sectors; our available cash, including to support current and planned clinical activities; uncertainties
as to our ability to obtain a listing of our common stock on Nasdaq; our ability to obtain and maintain intellectual property protection
for our product candidates; the success and timing of our preclinical studies including IND-enabling studies; the timing of our IND submissions;
our ability to get FDA approval for study amendments; the timing of data read-outs; the ability of our product candidates to successfully
perform in clinical trials; our ability to initiate, enroll, and execute pilots and clinical trials; our ability to maintain our existing
collaborations; our ability to manufacture and the performance of third-party manufacturers; the performance of our clinical research
organizations, clinical trial sponsors and clinical trial investigators; our ability to successfully implement our strategy; legislative,
regulatory and economic developments; unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism
or outbreak of war or hostilities, as well as management’s response to any of the aforementioned factors; and such other factors
as are set forth in our periodic public filings with the SEC, including but not limited to those described under the heading “Risk
Factors” in the Form 10-K for the fiscal year ended December 31, 2022 of Old Ayala, Inc. (f/k/a Ayala Pharmaceuticals, Inc.) and
the Form 10-K for the fiscal year ended October 31, 2022 of Ayala Pharmaceuticals, Inc. (f/k/a Advaxis, Inc.) (“Ayala” or
“we,” “us” or “our”), and such entities’ periodic public filings with the SEC, including but
not limited to those described under the heading “Risk Factors” in Ayala’s Form 10-K for the fiscal year ended October
31, 2022. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statement, or to make
any other forward-looking statements, whether as a result of new information, future events or otherwise.
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Ayala Pharmaceuticals (CE) (USOTC:ADXS)
Graphique Historique de l'Action
De Déc 2024 à Jan 2025
Ayala Pharmaceuticals (CE) (USOTC:ADXS)
Graphique Historique de l'Action
De Jan 2024 à Jan 2025