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6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of September 2024

Commission File Number: 001-40010

Pharvaris N.V.

(Translation of registrant’s name into English)

Emmy Noetherweg 2

 

2333 BK Leiden

 

The Netherlands
(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

 

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

PHARVARIS N.V.

 

Amendment to License Agreement

On September 20, 2024, Pharvaris N.V. (the “Company”) entered into an amendment (the “Amendment”) to the March 31, 2016 license agreement (the “AnalytiCon License”) with AnalytiCon Discovery GmbH (“AnalytiCon”) pursuant to which the Company acquired a worldwide, exclusive royalty-bearing license to use a certain proprietary substance class of bradykinin-B2-receptor antagonists with the potential of oral activity, for the purpose of developing, manufacturing and marketing compounds on a global basis for the treatment of, among others, hereditary angioedema. Certain rights associated with deucrictibant, PHVS416 and PHVS719 are subject to the AnalytiCon License.

The Amendment clarifies the scope of products upon which the Company will be required to pay a royalty, namely, any licensed product containing a compound within the scope of the Markush general formula (I) of claim 1 of US Patent No. 10,836,748. Each of deucrictibant, PHVS416 and PHVS719 is a royalty-bearing product.

The foregoing description of the Amendment does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Amendment, a copy of which is filed as Exhibit 99.1 to this Report on Form 6-K and which is incorporated herein by reference. The information included in this Form 6-K (including Exhibit 99.1) is hereby incorporated by reference into the Company’s registration statements on Form F-3 (Registration Numbers 333-278650, 333-277705 and 333-273757) and Form S-8 (Registration Number 333-252897).

 

 

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, thereunto duly authorized.

 

PHARVARIS N.V.

 

 

Date: September 23, 2024

By:

/s/ Berndt Modig

 

Name:

Berndt Modig

 

Title:

Chief Executive Officer

 

EXHIBIT INDEX

 

Exhibit

No.

 

Description

99.1

 

Amendment 2, between Pharvaris Netherlands B.V. and AnalytiCon Discovery GmbH dated as of September 20, 2024, to the License Agreement between Pharvaris B.V. and AnalytiCon Discovery GmbH dated as of March 31, 2016.

 

EX-99.1

Execution Version

 

Exhibit 99.1

 

 

 

 

 

Amendment 2

to the

License Agreement

entered into by

AnalytiCon Discovery GmbH and Pharvaris NV on 31st March 2016,

This Amendment 2 is made between

Pharvaris Netherlands BV

Emmy Noetherweg 2, 2333 BK Leiden, The Netherlands

“Pharvaris”

and

BRAIN Biotech AG

Darmstädter Str. 34 - 36, 64673 Darmstadt, Germany

“BRAIN Biotech”

BRAIN Biotech and Pharvaris in the following also referred to individually as “Party”
or collectively as “Parties”

 

 

 

Preamble

This Amendment 2 to License Agreement (“Amendment 2”) is dated as of September 20, 2024 by and between Pharvaris Netherlands BV, a company with limited liability incorporated in the Netherlands (“Pharvaris”), and BRAIN Biotech AG, a stock corporation incorporated in Germany (“BRAIN Biotech”). Capitalized terms used and not defined in this Amendment 2 have the meanings assigned to them in the License Agreement.

Recitals

WHEREAS, Pharvaris NV (FKA Pharvaris BV) and AnalytiCon Discovery GmbH (“AnalytiCon”) have entered into that certain License Agreement, dated as of March 31, 2016, as assumed by Pharvaris which replaced Pharvaris NV by way of an Assumption of Contract dated as of January 21/23, 2020 and as amended by that certain Amendment 1, dated as of January 9, 2021 (“Amendment 1”; the License Agreement, as amended from time to time, the “License Agreement”);

WHEREAS, AnalytiCon has transferred the License Agreement to BRAIN Biotech by way of a merger between AnalytiCon and BRAIN Biotech, effective as of June 6, 2024;

WHEREAS, BRAIN Biotech has proposed to sell, transfer and assign its right, title and interest in the payments BRAIN Biotech receives from Pharvaris pursuant to Section 5.3 of the License Agreement (subject to, as the case may be, reductions pursuant to Sections 5.5, 5.6, 6.4.4, 10.3.3, and 12.2.4 of, or otherwise pursuant to and in accordance with, the License Agreement) to Royalty Pharma Investments 2019 ICAV, an Irish collective asset-management vehicle (“Royalty Pharma”) on terms and conditions customary for such a monetization transaction, including the grant for the benefit of Royalty Pharma of a security interest in the License Agreement (the “RP Monetization”); and

WHEREAS, at the occasion of, but independently from, the RP Monetization, the Parties desire to amend the License Agreement to clarify certain terms related to the duration of the Pharvaris payment obligations under the License Agreement, as set forth herein.

NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby amend the License Agreement and agree as follows:

I.
After Section 1.27, the following new Section 1.27A is hereby added:

“1.27A “Royalty-Bearing Product(s)” shall mean any Licensed Product containing a compound within the scope of the Markush general formula (I) of claim 1 of US Patent No. 10,836,748. Each of deucrictibant (PHVS121), PHVS416 and PHVS719 is a Royalty-Bearing Product.”

II.
In Sections 1.13, 1.17, 1.22, 5.2, 5.3, 5.6, and 6.1 the words “Licensed Product(s)” (or corollary phrases “Licensed Product” or “Licensed Products” as applicable) are replaced by the words “Royalty-Bearing Product(s)” (or corollary phrases “Royalty-Bearing Product” or “Royalty-Bearing Products” as applicable).

1

 

III.
Section 1.28 is reworded as follows:

“1.28 “Sublicensee” shall mean such a Third Party which receives a commercial sublicense from Pharvaris under the Exclusive License to develop, market and sell Licensed Products(s) on its own account (and, if applicable, which is obligated to make payments to Pharvaris on the basis of royalty payments on Net Sales of Royalty-Bearing Product(s)).”

IV.
Section 4.2 is reworded as follows:

“4.2 Sublicensing

The Exclusive License includes the right of Pharvaris to grant sublicenses within the scope of the Exclusive License to its Affiliates or Third Parties to develop, market and sell Licensed Product(s) on its own account (if applicable, on the basis of royalty payments by Pharvaris to AnalytiCon on Net Sales of Royalty-Bearing Product(s) by such Sublicensees as further defined in this Agreement).”

V.
In Section 5.4, the words “Product” are replaced by words “Royalty-Bearing Product containing deucrictibant”, and the words “Backup Product” are replaced by the words “Royalty-Bearing Product not containing deucrictibant”.
VI.
In Section 5.5, the words “Product” are replaced by the words “Royalty-Bearing Product”.
VII.
Section 5.7.2 is reworded as follows:

“The Term of royalty payments with respect to each Royalty-Bearing Product shall be the Term with respect to such Royalty-Bearing Product.”

VIII.
In the first sentence of Section 10.1, the words “the expiry of the last Patent of the Licensed IP (the “Term”).” are replaced by the following words:

“(a) with respect to each Royalty-Bearing Product, the Expiration of the last Valid Claim of a Royalty-Bearing Patent that claims such Royalty-Bearing Product, on a Royalty-Bearing Product-by-Royalty-Bearing Product basis, and (b) with respect to each Licensed Product that is not a Royalty-Bearing Product, the Expiration of the last Valid Claim of a Non-Royalty-Bearing Patent that claims such Licensed Product, on a Licensed Product-by-Licensed Product basis (the “Term”).”

IX.
At the end of Section 10.1, the following new paragraphs are added:

“ “Valid Claim” means a claim of a Patent, including as such claim may be extended, whether through a patent term extension, supplementary protection certificate or otherwise, that has not expired, lapsed, been cancelled, abandoned or waived, or been dedicated to the public, disclaimed, rejected or held unenforceable, invalid, revoked or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, re-examination, reissue, disclaimer, inter partes review, inter partes review post grant procedures or similar

2

 

proceedings, and that has not otherwise become, or turned out to be, ineffective in whatever form and on whatever legal grounds. “Expiration” means any of the cases of ineffectiveness addressed in the preceding sentence.

“Royalty-Bearing Patent” means (a) US Patent No. 10,836,748 and (b) any patent or patent application (including any international patent or patent application) that shares a common priority with US Patent No. 10,836,748. The Patents listed on Schedule A are the Royalty-Bearing Patents that exist as of the date of this Amendment 2.

“Non-Royalty-Bearing Patent” means any Patent owned or controlled by Pharvaris that claims a Licensed Product that is not a Royalty-Bearing Product.”

X.
The schedule attached hereto as Schedule A is hereby appended to, and incorporated into, the License Agreement as a new Schedule A.
XI.
The License Agreement shall stay in force to the extent not explicitly amended by this Amendment 2.
XII.
This Amendment 2 shall only come into effect (and, subject to the terms and conditions of the License Agreement, remain in effect) upon the condition that the Consent Letter, as specified in Exhibit D-2 to the Royalty Purchase Agreement between Brain Biotech and Royalty Pharma, is duly executed and becomes effective among Brain Biotech, Pharvaris, and Royalty Pharma.

Remainder of page blank; signature page follows.

3

 

IN WITNESS THEREOF, the Parties hereto have caused this Amendment 2 to be executed in duplicate by their respective duly authorized representatives.

Date / Place 9/20/2024

 

Date / Place 9/20/2024

BRAIN Biotech AG

 

Pharvaris Netherlands BV, represented by its sole board member Pharvaris NV(Pharvaris)

(BRAIN Biotech)

 

(Pharvaris)

/s/ Adriaan Moelker

 

 /s/ Berndt Modig

Adriaan Moelker

 

Berndt Modig

Member of the Management Board

 

 Chief Executive Officer

 

 

 

Date / Place 9/20/2024

 

 

BRAIN Biotech AG

 

 

(BRAIN Biotech)

 

 

/s/ Michael Schneiders

 

 

Michael Schneiders

 

 

Member of the Management Board

 

 

 

 

 

 

 

 

Signature Page to Amendment 2

Schedule A

Country

Application no.

Publ. no. appl.

Grant/Registration No.

Publication of grant/
registration

Argentina

20180103444

AR113839 A1

Taiwan

107141872

202017916

I768156B

6/21/2022

Uruguay

37981

WIPO

PCT/EP2018/082338

WO 2019/101906 A1

Australia

2018371186

2018371186

AU2018371186B

8/25/2022

Brazil

BR 11 2020 010298 9

BR 11 2020 010298-9 A2

Canada

3,082,948

China

201880076162.X

WO 2019/101906 A1

CN111433196B

06.06.2023

Macao

J/007322

 J/007322

18.10.2023 / 26.09.2023

Colombia

NC2020/0006205

NC2020/0006205

CO 42230

22.02.2024 / 15.04.2024

Eurasia (EAPO)

EA 202091256

EA43330

5/15/2023

Armenia

AM/EA 43330

5/15/2023

Azerbaijan

AZ/EA 43330

5/15/2023

Belarus

BY/EA 43330

5/15/2023

Kazakhstan

KG/EA 43330

5/15/2023

Kyrgyz Republic

KZ/EA 43330

5/15/2023

Russian Federation

RU/EA 43330

5/15/2023

Tajikistan

TJ/EA 43330

5/15/2023

 

 

Country

Application no.

Publ. no. appl.

Grant/Registration No.

Publication of grant/
registration

Turkmenistan

TM/EA 43330

5/15/2023

Europe (EPC)

EP 18 818 992.2

3713928

EP3713928B1

1/12/2022

Albania

AL/EP3713928

1/12/2022

Austria

AT/EP3713928

1/12/2022

Bosnia and Herzegovina

BA/EP3713928

1/12/2022

Belgium

BE/EP3713928

1/12/2022

Bulgaria

BG/EP3713928

1/12/2022

Switzerland

CH/EP3713928

1/12/2022

Cyprus

CY/EP3713928 (CY1125348T1)

1/12/2022

Czech Republic

CZ/EP3713928

1/12/2022

Germany

DE/EP3713928

1/12/2022

Denmark

DK/EP3713928 (DK3713928T3)

1/12/2022

Estonia

EE/EP3713928

1/12/2022

Spain

ES/EP3713928 (ES2908409T3)

1/12/2022

Finland

FI/EP3713928

1/12/2022

France

FR/EP3713928

1/12/2022

United Kingdom

GB/EP3713928

1/12/2022

Greece

GR/EP3713928 (GR3110122)

1/12/2022

Hong Kong

HK 62020021917.3

HK40031700

HK40031700

14.04.2022

Croatia

HR/EP3713928 (HRP20220429)

1/12/2022

 

 

Country

Application no.

Publ. no. appl.

Grant/Registration No.

Publication of grant/
registration

Hungary

HU/EP3713928 (HU/E058217)

1/12/2022

Ireland

IE/EP3713928

1/12/2022

Iceland

IS/EP3713928

1/12/2022

Italy

IT/EP3713928

1/12/2022

Liechtenstein

LI/EP3713928

1/12/2022

Lithuania

LT/EP3713928 (LT3713928T)

1/12/2022

Luxembourg

LU/EP3713928

1/12/2022

Latvia

LV/EP3713928

1/12/2022

Morocco

MA50804B1

1/12/2022

Monaco

MC/EP3713928

1/12/2022

Montenegro

ME/EP3713928

1/12/2022

North Macedonia

MK/EP3713928

1/12/2022

Malta

MT/EP3713928

1/12/2022

Netherlands

NL/EP3713928

1/12/2022

Norway

NO/EP3713928

1/12/2022

Poland

PL/EP3713928 (PL3713928T3)

1/12/2022

Portugal

PT/EP3713928 (PT3713928T)

1/12/2022

Romania

RO/EP3713928

1/12/2022

Serbia

RS63087B1

1/12/2022

Sweden

SE/EP3713928

1/12/2022

 

 

Country

Application no.

Publ. no. appl.

Grant/Registration No.

Publication of grant/
registration

Slovenia

SI/EP3713928 (SI3713928T1)

1/12/2022

Slovakia

SK/EP3713928

1/12/2022

San Marino

SM/EP3713928 (SMT20220154)

1/12/2022

Tunisia

EP3713928 (TN/P/2022/0094)

1/12/2022

Türkiye

TR/EP3713928

1/12/2022

Europe (EPC)

21 213 719.4

3998259

Indonesia

P00202004204

IDP000082558

08/18/2022

Israel

274883

IL274883

10/2/2023

India

202017023470

IN419052

1/24/2023

Japan

2020-545875

JP7164619

11/1/2022

Republic of Korea

10-2020-7017972

KR10-2413321

6/22/2022

Mexico

MX/a/2020/005287

MX398255

12/8/2022

Nigeria

NG/PT/C/2020/4568

WO 2019/101906 A1

RP NG/PT/C/2020/4568

11/22/2022

New Zealand

764304

NZ764304

5/31/2024 / 5/24/2024

Philippines

1/2020/550683

Singapore

11202004653T

SG11202004653T

8/27/2024

United States of America

16/861,131

US 2020/0255405 A1

US10,836,748B2

11/17/2020

United States of America

17/033,347

US 2021/0017158 A1

US11,261,173B2

3/1/2022

 

 

Country

Application no.

Publ. no. appl.

Grant/Registration No.

Publication of grant/
registration

United States of America

17/578,161

US 2022/0135543 A1

US11,820,756B2

11/21/2023

South Africa

2020/03039

ZA2020/03039

11/24/2021