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): June 13, 2025
NextCure, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-38905 |
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47-5231247 |
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9000 Virginia Manor Road, Suite 200 Beltsville, Maryland |
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20705 |
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executive offices) |
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Registrant's telephone number, including area code: (240) 399-4900
(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:
☐ 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:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.001 par value per share |
NXTC |
Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company 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 1.01Entry into a Material Definitive Agreement
Licensing Agreement
On June 13, 2025, NextCure, Inc. (“NextCure” or the “Company”) entered into a License Agreement (the “Licensing Agreement”) with Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (“Zaiming”), a biopharmaceutical company based in China. Pursuant to the Licensing Agreement, the Company obtained (1) an exclusive, worldwide (excluding the Zaiming Territory, as identified below) license to develop, manufacture, and commercialize Zaiming’s clinical-stage antibody drug conjugate (“ADC”) candidate, SIM0505 (also known as SCR-9359), and related compounds (the “Zaiming Products”), and (2) a non-exclusive, worldwide (excluding the Zaiming Territory) license to use Zaiming’s ADC platform technology to develop ADCs based on the Company’s proprietary antibodies for an additional novel target (the “NextCure Products”).
Zaiming retained exclusive rights to develop and commercialize the Zaiming Products and any NextCure Products in mainland China, Hong Kong, Macau, and Taiwan (the “Zaiming Territory”).
Under the Licensing Agreement: (i) the Company agreed to pay $17 million to Zaiming, which includes an upfront cash payment of $12 million (the “Initial Payment”) and an additional $5 million that becomes payable upon the earlier of a qualifying financing event or December 31, 2025; (ii) upon initiation of the first Phase 2 clinical trial for SIM0505, the Company will issue to Zaiming $1 million in its common stock, or under certain conditions, pay an equivalent cash amount in lieu of common stock; (iii) the Company will pay Zaiming development and regulatory milestone payments of up to $166.5 million per Zaiming Product and up to $25.5 million per NextCure Product, and commercial sales-based milestone payments of up to $535 million; and (iv) the Company will also pay tiered royalties on annual net sales of licensed products, at rates ranging from mid-single digit to low double digit percentages for Zaiming Products; and low to mid-single digit percentages for NextCure Products, in all cases, subject to standard reductions.
The Company will be responsible for clinical development and commercialization of SIM0505 in the United States and other countries outside of the Zaiming Territory and is obligated to use commercially reasonable efforts to seek regulatory approvals in the U.S. and at least one other major market country. Zaiming retains exclusive rights in the Zaiming Territory and will continue development of SIM0505 in China.
Zaiming will also supply the Company with clinical material from existing inventory for immediate clinical trial needs and support a technology transfer to the Company for the manufacturing of future drug product. Additionally, each party retains ownership of its background IP and new inventions will be owned based on inventorship, with specified provisions for jointly developed IP.
The Licensing Agreement contains standard governance, exclusivity, confidentiality, indemnity, and termination provisions and the term of the Licensing Agreement will continue on a product-by-product, country-by-country basis until the expiration of the applicable royalty term.
The foregoing summary is a summary of the material terms of the Licensing Agreement, does not purport to be complete, and is qualified in its entirety by reference to the full text of the Licensing Agreement, which will be filed as an exhibit in our next quarterly report.
Private Placement
On June 13, 2025, the Company entered into Subscription Agreement (the “Subscription Agreement”) with Simcere Zaiming, Inc., a Delaware corporation and an affiliate of Zaiming (the “Subscriber”) pursuant to which, three Business Days following Zaiming receipt of the Initial Payment, the Company will issue and sell to the Subscriber in a private placement (the “Private Placement”), an aggregate of 4,063,633 shares (the “Shares”) of the common stock of the Company, par value $0.001 per share (the “Common Stock”), at a price of approximately $0.492 per Share for an aggregate purchase price of $2.0 million.
In connection with the Private Placement, the Company also entered into a Registration Rights Agreement with the Subscriber on June 13, 2025 (the “Registration Rights Agreement”). Pursuant to the terms of the Registration Rights Agreement, the Company is obligated (i) to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement (the “Registration Statement”) to register for resale the Shares, and (ii) to use its reasonable best efforts to cause the Registration Statement to be declared effective by the SEC as soon as practicable, in each case subject to certain deadlines.
The foregoing descriptions of the Subscription Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the form of Subscription Agreement and the Registration Rights Agreement, which are filed as Exhibit 10.1 and Exhibit 10.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
The representations, warranties and covenants contained in the Subscription Agreement and the Registration Rights Agreement were made solely for the benefit of the parties to the Subscription Agreements and the Registration Rights Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Subscription Agreement and the Registration Rights Agreement are incorporated herein by reference only to provide investors with information regarding the terms of the Subscription Agreement and the Registration Rights Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.
Item 3.02 Unregistered Sales of Equity Securities
To the extent required by Form 8-K, the disclosures in Item 1.01 above are incorporated herein by reference. The securities to be issued and sold to the Subscriber under the Subscription Agreement are not registered under the Securities Act of 1933, as amended (the “Securities Act”), and are being sold in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder. The Company relied on this exemption from registration based in part on representations made by the Subscriber. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy shares of common stock or other securities of the Company.
Item 7.01Regulation FD Disclosure
On June 16, 2025, the Company issued a press release announcing the Licensing Agreement and the Private Placement and made publicly available a corporate presentation that included information on SIM0505.
A copy of the press release and the data presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
Item 8.01Other Events
The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into mid-2026. The Company based this estimate on assumptions that may prove to be incorrect, and it could exhaust its available capital resources sooner than it currently expects.
Item 9.01Financial Statements and Exhibits
(d) Exhibits.
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Description |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURE
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.
Dated: June 16, 2025 |
NEXTCURE, INC. |
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By: |
/s/ Steven P. Cobourn |
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Name: |
Steven P. Cobourn |
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Title: |
Chief Financial Officer |
Exhibit 10.1
SUBSCRIPTION AGREEMENT
This Subscription Agreement (this “Subscription Agreement”) is dated as of June 13, 2025 (the “Execution Date”), by and between NextCure, Inc., a Delaware corporation (the “Company”), and Simcere Zaiming, Inc., a Delaware corporation (the “Subscriber”). The Company and the Subscriber are sometimes referred to herein as the “Parties.”
RECITALS
A. WHEREAS, concurrently with the execution of this Subscription Agreement, the Company and an affiliate of the Subscriber, Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (“Zaiming”) are entering into that certain License Agreement, dated as of the date hereof (the “License Agreement”).
B. WHEREAS, the Subscriber desires to subscribe for 4,063,633 shares (the “Shares”) of the Company’s common stock, $0.001 par value per share (the “Common Stock”), and the Company desires to issue to Subscriber the Shares, all on the terms and subject to the conditions set forth herein.
C. WHEREAS, the Company and the Subscriber are executing and delivering this Subscription Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) or Rule 506 of Regulation D (“Regulation D”) as promulgated by the United States Securities and Exchange Commission (the “SEC”) under the Securities Act.
D. Concurrently with the execution of this Subscription Agreement, the Company and the Subscriber are entering into a separate registration rights agreement dated as of the date hereof (the “Registration Rights Agreement”).
All capitalized terms not defined herein shall have the meanings assigned to them in the License Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained in this Subscription Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Subscriber hereby agree as follows:
Subscription.
(b)At the closing of the Subscription contemplated hereby (the “Closing”), the Subscriber shall make payment for the subscribed Shares by wire transfer of immediately available funds or by bank check in U.S. dollars in the amount of $2,000,000 (the “Subscription Proceeds”)
pursuant to the written instruction of the Company; simultaneously with the payment of such Subscription Proceeds, the Company shall cause the Shares to be delivered to the Subscriber, with the delivery of the Shares to be made through book entry confirmation from the Company’s transfer agent.
Representations and Warranties of the Company.
The Company represents and warrants as of the date hereof to the Subscriber as follows: (i) it has the full corporate power and authority to enter into this Subscription Agreement and to perform all of its obligations hereunder; (ii) this Subscription Agreement has been duly authorized and executed by, and when delivered in accordance with the terms hereof will constitute a valid and binding agreement of, the Company enforceable in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the rights and remedies of creditors generally or subject to general principles of equity; (iii) the execution and delivery of this Subscription Agreement and the consummation of the transactions contemplated hereby do not conflict with or result in a breach of the Company’s certificate of incorporation or bylaws and amendments thereto through the date hereof; and (iv) the Shares, when issued and paid for in accordance with the terms of this Subscription Agreement, will be duly authorized, validly issued, fully paid and non-assessable.
Representations, Warranties and Acknowledgments of the Subscriber.
The Subscriber hereby represents and warrants as of the date hereof to the Company as follows: (i) it has the full right, power and authority to enter into this Subscription Agreement and to perform all of its obligations hereunder; (ii) this Subscription Agreement has been duly authorized and executed by the Subscriber and, when delivered in accordance with the terms hereof, will constitute a valid and binding agreement of the Subscriber enforceable against the Subscriber in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the rights and remedies of creditors generally or subject to general principles of equity; (iii) the execution and delivery of this Subscription Agreement and the consummation of the transactions contemplated hereby do not conflict with or result in a breach of the Subscriber’s governing or organizational documents; (iv) prior to the execution of this Subscription Agreement, neither the Subscriber, nor any of its affiliates, require any consent, approval, authorization, or order of any court or governmental agency or body in connection with the Subscriber’s entry into the transactions contemplated herein except as such as may have already been obtained; (v) at the time the Subscriber was offered the Shares, it was, and at the date hereof it is, and on the date of the Closing it will be, an “accredited investor” as defined in Rule 501(a) under the Securities Act; (vi) the Subscriber is knowledgeable, sophisticated and experienced in making, and is qualified to make, decisions with respect to investments in securities representing an investment decision like that involved in the purchase of the Shares; (vii) the Subscriber has received and carefully reviewed each of this Subscription Agreement, the Accredited Investor Questionnaire (as defined below and attached hereto as Exhibit A), the License Agreement and any other documents or agreements explicitly contemplated hereunder (collectively, the “Transaction Documents”) and understand the information contained therein, prior to the execution of this Subscription Agreement; (viii) the Subscriber has had a reasonable opportunity to ask questions of and receive answers from the Company’s officers and any other persons authorized by the Company to answer such questions, concerning, among other related matters, the Shares, the Transaction Documents and the business, financial condition, results of operations and prospects of the Company and all such questions have been answered by the Company to the satisfaction of the Subscriber; (ix) the Subscriber has taken no action which would give rise to any claim by any person for brokerage commissions, finders’ fees or the like relating to this Subscription or the transactions contemplated hereby; (x) the Subscriber is not relying on the Company or any of its respective employees or agents with respect to the legal, tax, economic and related considerations of an investment in the Shares, and the Subscriber has relied on the advice of, or has consulted with, only its own advisors; (xi) the Subscriber is satisfied that it has received adequate information with respect to all matters which it considers material to its decision to make an investment in the Shares; and (xii) except as set forth below, the Subscriber is not a, and it has no direct or indirect affiliation or association with any, member of the Financial Industry Regulatory Authority, Inc. (“FINRA”) or an Associated Person (as such term is defined under the FINRA Rules) as of the date hereof.
The Subscriber hereby also represents and warrants as of the date hereof to the Company that, other than the transactions contemplated hereunder, the Subscriber has not, directly or indirectly, nor has any person acting on behalf of or pursuant to any understanding with the Subscriber, executed any transactions in securities of the Company, including “short sales” (“Short Sales”) as defined in Rule 200 of Regulation SHO under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), during the period commencing from the time that the Subscriber first became aware of the proposed transactions contemplated hereunder until the date hereof (the “Discussion Time”). The Subscriber has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction).
Covenants of the Company.
(c)Registration of the Shares. As promptly as practical and no later than thirty (30) days after the Closing Date (as defined below), the Company shall file with the SEC the registration statement in connection with the registration under the Securities Act of the Shares in accordance with the Registration Rights Agreement and shall use its reasonable best efforts to cause the registration statement to clear comments from the SEC and become effective.
Covenants of the Subscriber.
| (i) | Compliance with Laws. In addition to other restrictions set forth in this Section 5, the Subscriber covenants that the Shares may be disposed of only pursuant to an effective registration statement under, and in compliance with the requirements of, the Securities Act, or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, and in compliance with any applicable state and federal securities laws. In connection with any transfer of the Shares other than (i) pursuant to an effective registration statement, (ii) to the Company, or (iii) pursuant to Rule 144 (provided that the Subscriber provides the Company with reasonable assurances (in the form of seller and, if applicable, broker representation letters) that the Shares may be sold pursuant to such rule), the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor and reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Shares under the Securities Act. As a condition of transfer, any such transferee shall agree |
| in writing to be bound by the terms of this Subscription Agreement by executing a joinder agreement to each of the same, and shall have the rights of the Subscriber under this Subscription Agreement with respect to such transferred Shares upon such execution. |
| (ii) | Legends. Book entry confirmations evidencing the Shares shall bear any legend as required by the “blue sky” laws of any state and a restrictive legend in substantially the following form, until such time as they are not required, as reasonably determined by the Company: |
THESE SHARES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR APPLICABLE STATE SECURITIES LAWS. THE SHARES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED (I) IN THE ABSENCE OF (A) AN EFFECTIVE REGISTRATION STATEMENT FOR THE SHARES UNDER THE SECURITIES ACT OR (B) AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS OR BLUE SKY LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY AND ITS TRANSFER AGENT OR (II) UNLESS SOLD PURSUANT TO RULE 144 UNDER SAID ACT.
Closing Date and Pre-Closing Conditions.
The Company’s Common Stock is listed and trading on the Nasdaq Global Select Market and, except as has been publicly disclosed by Company with respect to the minimum bid price requirement of Nasdaq Rule 5810, the Company is in compliance in all material respects with the Company’s reporting, filing and other obligations under the rules and regulations of Securities Act, Exchange Act, SEC and Nasdaq; and
The Company has paid in full the First Payment in accordance with the Section 6.1(a) of the License Agreement, and the receipt of such payment has been confirmed in writing by Zaiming on or after the date of actual receipt.
Termination.
(a)The Subscriber may terminate this Subscription Agreement by written notice to the Company if:
(i)the Company’s Common Stock has been delisted from Nasdaq and is no longer traded on any other publicly traded stock market;
(ii)the License Agreement is terminated;
(iii)the Shares have not been registered pursuant to an effective registration statement within nine (9) months following the Execution Date; or
(iv)any law or order enacted, issued or enforced by any governmental authority that prevents or prohibits consummation of the transactions contemplated hereby.
(b)In the event that the Subscription Agreement is terminated but the License Agreement remains in full force and effect, the respective rights and obligations of the Parties shall be governed by the terms set forth in the License Agreement.
(c)To the extent applicable, termination of this Subscription Agreement shall not affect any rights or liabilities that have accrued to either Party as of the effective date of termination. If this Subscription Agreement is terminated pursuant to Section 7(a)(iii) above, the Subscriber shall be entitled to demand that the Company repurchase such Shares at a repurchase price equal to the Subscription Proceeds that Subscriber paid for the Shares.
Miscellaneous.
All communications hereunder, except as may be otherwise specifically provided herein, shall be in writing and shall be mailed, hand delivered, sent by a recognized overnight courier or sent via facsimile or by e-mail delivery and confirmed by letter, to the party to whom it is addressed at the following addresses or such other address as such party may advise the other in writing:
If to the Company:NextCure, Inc.
9000 Virginia Manor Rd. Suite 200
Beltsville, MD 20705
Attn: CEO
With a copy to (which shall not constitute notice):
Sidley Austin LLP
2860 Quarry Lake Dr.
Suite 301 Baltimore, MD 21209
Attn: Asher Rubin
If to the Subscriber: Simcere Zaiming, Inc.
20 Acorn Park Drive, Suite 200
Cambridge, MA 02140
Attn: CEO
With a copy to (which shall not constitute notice):
Jun He Law Offices LLC
Suite 1919, 630 Fifth Avenue
New York, NY 10111
Attn: Lan Lou, Esq.
All notices hereunder shall be effective upon receipt by the party to which it is addressed.
No provision of this Subscription Agreement may be waived, modified, supplemented or amended except in a written instrument signed, in the case of an amendment, by the Company and the Subscriber or, in the case of a waiver, by the party against whom enforcement of any such waiver is sought. No waiver of any default with respect to any provision, condition or requirement of this Subscription Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of either party to exercise any right hereunder in any manner impair the exercise of any such right.
This Subscription Agreement shall be governed by and interpreted in accordance with the laws of the State of Delaware for contracts to be wholly performed in such state and without giving effect to the principles thereof regarding the conflict of laws.
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IN WITNESS WHEREOF, each of the Company and Subscriber has executed or caused this Subscription Agreement to be executed by its duly authorized representative as of the date set forth below.
NEXTCURE, INC.
By: |
_/s/ Michael Richman__ |
Date: June 13, 2025
SUBSCRIBER: SIMCERE ZAIMING, INC.
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Signature of Subscriber: /s/Tang Renhong |
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By: |
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Name:Renhong Tang |
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Title:CEO of Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (“Zaiming”) |
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Date: June 13, 2025
EXHIBIT A
Exhibit 10.2
REGISTRATION RIGHTS AGREEMENT
This Registration Rights Agreement (this “Agreement”) is made and entered into as of June 13, 2025, by and among NextCure, Inc., a Delaware corporation (the “Company”), and Simcere Zaiming, Inc., a Delaware corporation (the “Investor”).
This Agreement is made in connection with the Subscription Agreement (the “Subscription Agreement”), dated as of the date hereof, by and between the Company and the Investor. All capitalized terms not defined herein shall have the meanings assigned to them in the Subscription Agreement.
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Investor agree as follows:
“Advice” has the meaning set forth in Section 6(c).
“Affiliate” means, with respect to any Person, any other person which directly or indirectly controls, is controlled by, or is under common control with, such Person; as such terms are used in and construed under Rule 405 of the Securities Act.
“Agreement” has the meaning set forth in the Preamble.
“Business Day” means any day except Saturday, Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“Closing Date” has the meaning set forth in the Subscription Agreement.
“Commission” means the Securities and Exchange Commission.
“Common Stock” means the common stock of the Company, par value $0.001 per share, and any securities into which such common stock may hereinafter be reclassified.
“Company” has the meaning set forth in the Preamble.
“Effective Date” means each date that the Registration Statement filed pursuant to Section 2(a) and any post-effective amendment thereto is declared effective by the Commission.
“Effectiveness Deadline” means, with respect to the Initial Registration Statement or the New Registration Statement, the 60th calendar day following the Closing Date (or, in the event the Commission reviews and has written comments to the Initial Registration Statement or the New Registration Statement, the 120th calendar day following the Closing Date); provided, however, that if the Effectiveness Deadline falls on a Saturday, Sunday or other day that the Commission is closed for business, the Effectiveness Deadline shall be extended to the next Business Day on which the Commission is open for business.
“Effectiveness Period” has the meaning set forth in Section 2(b).
“Exchange Act” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.
“Filing Deadline” means, with respect to the Initial Registration Statement required to be filed pursuant to Section 2(a), the 30th calendar day following the Closing Date; provided, however, that if the Filing Deadline falls on a Saturday, Sunday or other day that the Commission is closed for business, the Filing Deadline shall be extended to the next business day on which the Commission is open for business.
“FINRA” has the meaning set forth in Section 3(h).
“Indemnified Party” has the meaning set forth in Section 5(c).
“Indemnifying Party” has the meaning set forth in Section 5(c).
“Initial Registration Statement” means the initial Registration Statement filed pursuant to Section 2(a) of this Agreement.
“Investor” has the meaning set forth in the Preamble.
“Losses” has the meaning set forth in Section 5(a).
“New Registration Statement” has the meaning set forth in Section 2(a).
“Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.
“Principal Market” means the Trading Market on which the Common Stock is primarily listed and quoted for trading, which, as of the date hereof, is the Nasdaq Global Select Market.
“Proceeding” means an action, claim, suit, investigation or proceeding (including, without limitation, an investigation or partial proceeding, such as a deposition), whether commenced or threatened.
“Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.
“Registrable Securities” means all of the Shares and any securities issued or issuable upon any stock split, dividend or other distribution, recapitalization or similar event with respect to the foregoing; provided, that the Investor has completed and delivered to the Company a Selling Stockholder Questionnaire; and provided, further, that the Shares shall cease to be Registrable Securities upon the earliest to occur of the following: (a) a sale pursuant to a Registration Statement or Rule 144 under the Securities Act (in which case, only such security sold by the Investor shall cease to be a Registrable Security); or (b) such securities becoming eligible for resale by the Investor under Rule 144 without the requirement for the Company to be in compliance with the current public information requirement thereunder and without volume or manner-of-sale restrictions, pursuant to a written opinion letter to such effect, addressed, delivered and acceptable to the Transfer Agent.
“Registration Statements” means any one or more registration statements of the Company filed under the Securities Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement (including, without limitation, the Initial Registration Statement, the New Registration Statement and any Remainder Registration Statements), including (in each case) the amendments and supplements to such Registration Statements, including pre- and post-effective amendments thereto, all exhibits and all material incorporated by reference or deemed to be incorporated by reference in such Registration Statements.
“Remainder Registration Statements” has the meaning set forth in Section 2(a).
“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such rule.
“Rule 415” means Rule 415 promulgated by the Commission pursuant to the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such rule.
“Rule 424” means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such rule.
“SEC Guidance” means (a) any publicly-available written or oral guidance, comments, requirements or requests of the Commission staff, provided, that any such oral guidance, comments, requirements or requests are reduced to writing by the Commission, and (b) the Securities Act.
“Securities Act” means the Securities Act of 1933, as amended, or any successor statute, and the rules and regulations promulgated thereunder.
“Selling Stockholder Questionnaire” means a questionnaire in the form attached as Annex B hereto, or such other form of questionnaire as may reasonably be adopted by the Company from time to time.
“Shares” means the shares of Common Stock issued or issuable to the Investor pursuant to the Subscription Agreement.
“Subscription Agreement” has the meaning set forth in the Preamble.
In connection with the Company’s registration obligations hereunder, the Company shall:
An Indemnified Party shall have the right to employ separate counsel in any such Proceeding and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Indemnified Party or Parties unless: (i) the Indemnifying Party has agreed in writing to pay such fees and expenses; (ii) the Indemnifying Party shall have failed promptly to assume the defense of such Proceeding and to employ counsel reasonably satisfactory to such Indemnified Party in any such Proceeding; or (iii) the named parties to any such Proceeding (including any impleaded parties) include both such Indemnified Party and the Indemnifying Party, and such Indemnified Party shall have been advised by counsel that a conflict of interest would exist if the same counsel were to represent such Indemnified Party and the Indemnifying Party (in which case, if such Indemnified Party notifies the Indemnifying Party in writing that it elects to employ separate counsel at the expense of the Indemnifying Party, the Indemnifying Party shall not have the right to assume the defense thereof and such counsel shall be at the expense of the Indemnifying Party); provided, that the Indemnifying Party shall not be liable for the fees and expenses of more than one separate firm of attorneys at any time for all Indemnified Parties.
The Indemnifying Party shall not be liable for any settlement of any such Proceeding effected without its prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned. No Indemnifying Party shall, without the prior written consent of the Indemnified Party, effect any settlement of any pending Proceeding in respect of which any Indemnified Party is a party, unless such settlement includes an unconditional release of such Indemnified Party from all liability on claims that are the subject matter of such Proceeding and such settlement does not include any non-monetary limitation on the actions of any Indemnified Party or any of its affiliates or any admission of fault or liability on behalf of any such Indemnified Party. Notwithstanding any other provision of this Section 5(c), if an Indemnified Party withholds its consent to a bona fide settlement offer, where but for such action the Indemnifying Party could have settled a Proceeding, the Indemnifying Party will be required to indemnify the Indemnified Party only up to the amount of the bona fide settlement offer for which the Indemnifying Party could have settled such Proceeding.
Subject to the terms of this Agreement, all fees and expenses of the Indemnified Party (including reasonable fees and expenses to the extent incurred in connection with investigating or preparing to defend such Proceeding in a manner not inconsistent with this Section 5) shall be paid to the Indemnified Party, as incurred, within 20 Business Days of written notice thereof to the Indemnifying Party; provided, that the Indemnified Party shall promptly reimburse the Indemnifying Party for that portion of such fees and expenses applicable to such actions for which such Indemnified Party is finally judicially determined to not be entitled to indemnification hereunder. The failure to deliver written notice to the Indemnifying Party within a reasonable time of the commencement of any such action shall not relieve such Indemnifying Party of any liability to the Indemnified Party under this Section 5, except to the extent that the Indemnifying Party is materially and adversely prejudiced in its ability to defend such action.
The parties hereto agree that it would not be just and equitable if contribution pursuant to this Section 5(d) were determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to in the immediately preceding paragraph. Notwithstanding the provisions of this Section 5(d), (A) the Investor shall not be required to contribute, in the aggregate, any amount in excess of the amount by which the net proceeds actually received by the Investor from the sale of the Registrable Securities subject to the Proceeding exceeds the amount of any damages that the Investor has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission and (B) no contribution will be made under circumstances where the maker of such contribution would not have been required to indemnify the Indemnified Party under the fault standards set forth in this Section 5. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation.
The indemnity and contribution agreements contained in this Section 5 are in addition to any liability that the Indemnifying Parties may have to the Indemnified Parties and are not in diminution or limitation of the indemnification provisions under the Subscription Agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the date first written above.
COMPANY
NextCure, Inc.,
a Delaware corporation
By: /s/ Michael Richman
Name: Michael Richman
Title: President & CEO
[SIGNATURE PAGEOF INVESTORFOLLOWS]
IN WITNESS WHEREOF, the parties have executed this Registration Rights Agreement as of the date first written above.
INVESTOR:
SIMCERE ZAIMING, INC.
AUTHORIZED SIGNATORY
By: /s/Renhong Tang
Name: Renhong Tang
Title: CEO of Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (“Zaiming”)
ANNEX A
PLAN OF DISTRIBUTION
The Investor and any of its assignees and successors-in-interest (collectively the “Selling Stockholders”) may, from time to time, sell any or all of their shares of Common Stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These sales may be at fixed or negotiated prices. The Selling Stockholders may use any one or more of the following methods when selling shares:
| ● | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| ● | block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
| ● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| ● | an exchange distribution in accordance with the rules of the applicable exchange; |
| ● | privately negotiated transactions; |
| ● | broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share; |
| ● | a combination of any such methods of sale; and |
| ● | any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell shares under Rule 144 under the Securities Act of 1933, as amended, if available, rather than under this prospectus.
Broker-dealers engaged by the Selling Stockholders may arrange for other broker-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser) in amounts to be negotiated. The Selling Stockholders do not expect these commissions and discounts to exceed what is customary in the types of transactions involved.
The Selling Stockholders and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act.
We are required to pay all fees and expenses incident to the registration of the shares, but not including certain fees and disbursements of counsel to the Selling Stockholders; in addition, a Selling Stockholder will pay all underwriting discounts and selling commissions, if any. We have agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We may be indemnified by the Selling Stockholders against civil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished to us by the Selling Stockholder specifically for use in this prospectus, in accordance with the registration rights agreement, or we may be entitled to contribution.
To the extent required, we will amend or supplement this prospectus to disclose material arrangements regarding the plan of distribution.
To comply with the securities laws of certain jurisdictions, registered or licensed brokers or dealers may need to offer or sell the shares offered by this prospectus. The applicable rules and regulations under the Securities Exchange Act of 1934, as amended, may limit any person engaged in a distribution of the shares of common stock covered by this prospectus in its ability to engage in market activities with respect to such shares. A Selling Stockholder, for example, will be subject to applicable provisions of the Exchange Act and the rules and regulations under it, including, without limitation, Regulation M of the Exchange Act, which provisions may limit the timing of purchases and sales of any shares of common stock by that Selling Stockholder. Regulation M may also restrict the ability of any person engaged in the distribution of the shares of common stock to engage in market-making activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the shares of common stock and the ability of any person or entity to engage in market-making activities with respect to the shares of common stock.
ANNEX B
Exhibit 99.1
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
| - | NextCure gains global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights |
| - | Phase 1 clinical trial ongoing for SIM0505 in China; U.S. Phase 1 clinical trial is expected to begin in the third quarter of 2025 |
| - | Initial Phase 1 clinical data is expected in the first half of 2026 |
| - | NextCure also gains rights to Simcere Zaiming’s proprietary linker and payload for use in an ADC directed to a NextCure novel target; Simcere Zaiming will have rights to greater China |
BELTSVILLE, Md. USA, / Shanghai China, June 16, 2025 – NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025.
SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming’s proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models.
SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration.
The partnership also includes a license for NextCure to access Simcere Zaiming’s proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC.
“We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6.
Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors,” said Michael Richman, NextCure’s president and CEO. “We look forward to initiating clinical development of SIM0505 in the United States.”
“We are very pleased to collaborate with NextCure on the global development of SIM0505," said Renhong Tang, PhD, CEO of Simcere Zaiming. "SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure’s recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide.”
Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. http://www.nextcure.com
About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners.
NextCure’s Cautionary Statement Regarding Forward-Looking Statements
Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.
Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
NextCure Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
Simcere Zaiming Contacts
PR contacts: pr@zaiming.com
IR contacts: ir@zaiming.com
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NASDAQ: NXTC SIM0505 LNCB74 J U N E 2 0 2 5 Corporate Presentation |
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Forward-Looking Statements 2 To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to NextCure as of the date hereof. Forward-looking statements include statements regarding NextCure’s expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “may,” “will,” “potential,” “expects,” “believes,” “intends,” “hope,” “towards,” “forward,” “later” and similar expressions. Examples of forward-looking statements in this presentation include, among others, statements about our licensing agreement with Simcere Zaiming, statements about the development plans for our products, statements about the progress and evaluation and expected timing of results of NextCure’s ongoing or planned clinical trials, expectations regarding the potential benefits, activity, effectiveness and safety of our research stage, preclinical stage, and clinical stage therapeutic candidates, NextCure’s financial guidance, expected upcoming milestones, and NextCure’s plans, objectives and intentions with respect to the discovery and development of therapeutic products. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and no products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on NextCure’s discovery platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including in Item 1A of NextCure’s most recent Form 10-K, subsequent Forms 10-Q and elsewhere in the Company’s filings with the SEC. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, except as required by law, even if expectations change. |
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3 Developing 2 Differentiated ADCs RUNWAY • LNCB74 and SIM0505 Ph1 readouts expected in 1H 2026 • Mid-2026 • Leverage existing infrastructure to initiate US trial in 3Q 2025 • Combine China & US Ph1 data for fast and definitive POC OUR APPROACH NEW OPPORTUNITY • Global rights (ex-China) for Simcere Zaiming’s SIM0505 (CDH6) • Ph1 initiated in China and FDA IND cleared |
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Novel ADCs: Designed for Multi-Pronged Approach to Improve Efficacy 4 TARGETS PAYLOADS B7-H4 Tubulin Inhibitor LNCB74 CDH6 Topoisomerase 1 Inhibitor SIM0505 •Tumor Eradication •Overcoming Resistance •Increasing Durability •Cancer Types •Limited Treatment Options •Aging Population •Medical Costs |
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Ongoing Ph1 Trials with Differentiated ADCs 5 PROGRAMS TARGET PAYLOAD PRECLINICAL PHASE 1 LNCB74 B7-H4 MMAE SIM0505 CDH6 TOPOi Co-development with Breast, Ovarian, Endometrial Ovarian, Lung, Renal |
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6 STRATEGIC PARTNERSHIP Global license (ex China) from Simcere Zaiming DIFFERENTIATED ADC • Proprietary CPT116 TOPOi • Unique epitope & high affinity PH1 CLINICAL ASSET • Clinical trial ongoing in China • NXTC to initiate US Ph1 3Q 2025 • Combine US and China data for speed to POC MULTIPLE INDICATIONS Ovarian, Lung & Renal CDH6 ADC SIM0505 |
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SIM0505 is a Differentiated CDH6 TOPOi ADC 7 Payload CPT116 (TOPOi) GGFG Linker CDH6 mAb DAR 8.0 Cysteine conjugation Gly-Gly-Phe-Gly Provides Tumor-Specific Cleavage Unique Binding Epitope with Increased Affinity High Systemic Clearance for Reduced Toxicity Linker Potent Cytotoxicity with Anticipated Safety Improvement VALIDATED TARGET WITH PROPRIETARY TOPOi PAYLOAD |
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CDH6 Competition and Differentiation 8 Key Features SIM0505 DS-6000 CUSP06 HS-20124 QLS-5133 ADC Design • CDH6 mAb (EC1) • CDH6 mAb (EC3) • CDH6 mAb (EC3) • CDH6 mAb low affinity • CDH6 mAb (high affinity) • GGFG cleavable linker • GGFG cleavable linker • Dipetide-T1000-e platform • Tetrapeptide cleavable linker • Cleavable linker • TOPO1 inhibitor (CPT116) • TOPO1 inhibitor (DXd) • TOPO1 inhibitor (Exatecan) • Proprietary • TOPO1 inhibitor (QLS6916) • DAR 8 • DAR 8 • DAR 8 • DAR 8 • DAR 8 Stage of Development Ph1 (China); US IND filed and cleared Ph3 Ph1 Ph1 (China) Q2 2025 (IND) Activity (Preclinical/ Clinical) Preclinical: Single dose activity at 1mg/kg in OVCAR-3 (Ovarian), PA-1 (Ov. teratocarcinoma), 786- 0 (renal cell carcinoma) models Ph1 results: Confirmed OVCA ORR: 46% CR:1; PR:22. DCR: 98% Median DOR: 11.2 months Median PFS: 7.9 months Ongoing Ph2/3 study Ph1 results: All tumors ORR: 36% PR:5 Preclinical: Activity in multiple dosing (QWX3) at 1.5 mg/kg (less pronounced) in OVCAR3 model Preclinical: Activity in single lowest dose (12mg/kg) in PA-1 model and 3mg/kg in OVCAR3 models. Common AEs & SAEs No major toxicity observed in NHPs; No ILD reported in NHP tox studies ILD, Anemia, neutropenia, nausea Anemia, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, & vomiting Unknown Unknown Next Data Readout • 1H 2026 (China & US) • YE 2027 • Unknown Unknown Unknown Based on independent public sources and not based on direct comparisons 2023 ASCO 2025 |
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SIM0505 Antibody Binding Differentiation 9 mAb Human CDH6 Cyno CDH6 Rat CDH6 Mouse CDH6 mAb003-H2L3 0.028 0.029 0.025 0.026 DS-H01L02 0.454 0.148 No binding No binding EC50 (nM) mAb003-H2L3: SIM0505 mAb intermediate Comparator: Analog of DS-H01L02 (DS-6000 mAb intermediate) -5 -4 -3 -2 -1 0 1 2 3 0 1 2 3 4 Human CDH6-His Ab Conc Log(nM) OD450 mAb003-H2L3 Comparator Control -5 -4 -3 -2 -1 0 1 2 3 0 1 2 3 4 Rat CDH6-His Ab Conc Log(nM) OD450 mAb003-H2L3 Comparator Control -5 -4 -3 -2 -1 0 1 2 3 0 1 2 3 4 Mouse CDH6-His Ab Conc Log(nM) OD450 mAb003-H2L3 Comparator Control -5 -4 -3 -2 -1 0 1 2 3 0 1 2 3 4 Cyno CDH6-His Ab Conc Log(nM) OD450 mAb003-H2L3 Comparator Control Courtesy of Simcere Zaiming Human CDH6-His Cyno CDH6-His Rat CDH6-His Mouse CDH6-His |
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SIM0505 Ovarian Cancer Cell Line Binding Differentiation 10 -3 -2 -1 0 1 2 3 0 2000 4000 6000 8000 10000 12000 OVCAR3 Ab Conc Log(nM) Median MFI SIM0505 Comparator Control -3 -2 -1 0 1 2 3 0 2000 4000 6000 8000 10000 12000 PA-1 Conc (nM) Median MFI SIM0505 Comparator Control Courtesy of Simcere Zaiming Comparator: Analog of DS-6000 OVCAR-3 PA-1 |
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SIM0505 Active in Ovarian and Renal Tumor Models 11 0 5 8 12 16 19 22 27 0 200 400 600 800 1000 OVCAR3 CDX Days after treatment Tumor volume (mm 3 ) No Treatment SIM0505 (3 mg/kg) Comparator (3 mg/kg) 0 4 8 11 15 18 22 25 0 200 400 600 800 1000 PA-1 CDX Days after treatment Tumor volume (mm 3 ) No Treatment SIM0505 (3 mg/kg) Comparator (3 mg/kg) 0 3 8 11 14 17 21 24 28 0 200 400 600 800 1000 786-O CDX Days after treatment Tumor volume m( m 3 ) No Treatment SIM0505 (10 mg/kg) Comparator (10 mg/kg) OVARIAN (OVCAR-3) CDX OVARIAN (PA-1) CDX RCC (786-O) CDX Courtesy of Simcere Zaiming Comparator: Analog of DS-6000 Single dose 6 mice / group Single dose 6 mice / group Single dose 6 mice / group |
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Accelerating SIM0505 Global Development Expected Data Readout POC 1H 2026 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Backfill Cohorts ✓ 12 Dose Expansion • 6 dose cohorts • Regimen Q3W • N=54 subjects • 3 dose cohorts • 2 tumor types • N=120 subjects • Pre & on treatment biopsies Patient selection strategy Patient selection strategy Dose Escalation Dose Expansion OVARIAN LUNG RENAL Readout: Scans every 6 weeks Endpoint: Safety & ORR (China & US data) Cohort 5 Cohort 6 Zaiming Initiated Ph1 in China March 2025 *Joint Global Development NXTC to enroll patients starting cohort 3 in US *NXTC has global rights, ex-China |
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SIM0505 Phase 1 Initial Clinical Data Summary (as of April 16, 2025) 13 • 5 patients to date ̶ Dose level 1 (1.6 mg/kg): 3 ̶ Dose level 2 (3.2 mg/kg): 2 • Tumor types ̶ High-grade serous ovarian cancer: 3 ̶ Serous endometrial carcinoma: 1 ̶ Poorly differentiated endometroid adenocarcinoma: 1 • Dose level 1 ̶ No DLTs ̶ No Grade ≥3 TEAEs, SAEs or AEs leading to dose adjustment ̶ 1 Grade 2 TEAE (transient white blood cells count decreased, study drug-related, recovered without medication) • Dose level 2 ̶ Still within DLT period ̶ No DLTs ̶ No Grade ≥3 TEAE or SAE • 6-week tumor assessment • PR seen at the lowest dose ̶ Serous endometrial carcinoma ̶ 43% reduction in target lesions ̶ Reduction in non-target lesions ENROLLMENT SAFETY INITIAL ACTIVITY Courtesy of Simcere Zaiming |
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EGFRwt, CDH6 H-score 250 EGFRwt, CDH6 H-score 190 EGFRwt/ALKm, CDH6 H-score 213 Expanding in NSCLC 14 Courtesy of Simcere Zaiming *Primary antibody: Caherin-6 (D3T3I, Rabbit mAb, CST; Leica BOND III platform) EGFRwt (H-score 250) EGFRwt (H-score 190) EGFRwt/ALKm (H-score 213) Cancer Stage Sample Type Sub-type Sample size CDH6* 1+/2+/3+ ≥ 10% TC CDH6 H-Score 1 - 99 CDH6 H-Score 100 - 300 IIIB ~VI Tumor Biopsy of Lung Adenocarcinoma EGFRwt 28 21.4% (6/28) 3.6% (1/28) 17.9% (5/28) EGFRm 86 2.3% (2/86) 1.2% (1/86) 1.2% (1/86) |
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POTENTIAL FOR IMPROVED SAFETY & EFFICACY Opportunity to Develop Differentiated CDH6 ADC Therapeutic 15 CDH6 ADC ONGOING PH1 TRIAL IN CHINA PH1 CLINICAL POC EXPECTED 1H 2026 SIM0505 |
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16 LNCB74 B7-H4 ADC DIFFERENTIATED ADC Unique antibody linker STRATEGIC PARTNERSHIP 50/50 co-development partnership with LigaChem Biosciences MULTIPLE INDICATIONS Breast, Ovarian, Endometrial PH1 CLINICAL ASSET • US clinical trial ongoing • CLIA validated IHC biomarker assay |
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LNCB74 is a Differentiated Anti-B7-H4 MMAE ADC Fc Modification Protects immune cells Tumor Selectivity Glucuronidase cleavable linker provides improved safety & increased efficacy 17 MMAE DAR 4 Improves targeted release and safety Antibody Linker Payload STRUCTURAL DIFFERENTIATION |
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LNCB74 Uses Differentiating Glucuronidase Linker Designed for Improved Safety & Increased Efficacy 18 Bloodstream Tissues Cancer Cell Bystander Effect Linker Glucuronidase cleavable Payload Tubulin inhibitor Conjugation Site Specific DAR 4 •Efficient release of toxin •Higher concentration Stable Potent Solution Reduced Toxicity + + Transfer to albumin Released by platelets & neutrophils Unstable Toxicity •Inefficient release of toxin •Lower concentration Less potent Limitation Linker Protease or esterase cleavable Payload Tubulin or Topo-1 inhibitors Conjugation Site Specific or non-specific cysteine DAR ~4, 6, 8 Val-cit Linkers Glucuronidase Linker |
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Key Differentiating Features of Glucuronidase Linkers 19 Time (Hours) Relative Toxin Concentration per Cancer Cell 100% Val-cit Linker Glucuronidase Linker Control ADC Glucuronidase Linker Val-cit Linker Site specific attachment to mAb □ Non-specific attachment to mAb Highly stable linkage □ Unstable linkage ‒ Prone to transferring to albumin ‒ Increases toxicity Specifically cleaved in cancer cells □ Susceptible to cleavage by platelets and neutrophils, increasing toxicity Efficient release of payload □ Less efficient release of payload Higher concentration of cytotoxic drug per cancer cell □ Lower concentration of cytotoxic drug per cancer cell • Improved therapeutic index • Increased potency • Lower toxicity • Less frequent dosing |
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20 LNCB74 Showed Potent Anti-Tumor Activity in CDX and PDX Models OVARIAN (OVCAR-3-B7-H4-OE) Days from Treatment Initiation Mean Volume (mm3) +/- SEM TNBC (CTG-0012) Mean Volume (mm3) +/- SEM Days from Treatment Initiation BREAST (ZR-75-1) Days from Treatment Initiation Mean Tumor Volume (mm3) +/- SEM CDX PDX Q7D x 3 8 mice / group 1.5 mg/kg: Q7D x 3 4.5 mg/kg: single dose 8 mice / group Single dose 5 mice / group 0 7 14 21 28 35 0 500 1000 1500 2000 No Treatment LNCB74 (6 mg/kg) LNCB74 (3 mg/kg) LNCB74 (1 mg/kg) 0 7 14 21 28 35 42 49 0 500 1000 1500 2000 No Treatment LNCB74 (6 mg/kg) 100% CRs 0 7 14 21 28 35 42 0 500 1000 1500 2000 No Treatment LNCB74 (1.5 mg/kg) LNCB74 (4.5 mg/kg) |
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B7-H4 Competition and Differentiation Key Features LNCB74 XMT-1660 HS-20089 AZD8205 DB-1312 / BG-C9074 ADC Design • B7-H4 mAb • B7-H4 mAb • B7-H4 mAb • B7-H4 mAb • B7-H4 mAb • Glucuronidase cleavable linker • Protease cleavable linker • Protease cleavable linker • Pegylated Val-Ala cleavable linker • GGFG cleavable linker • Monomethyl Auristatin E (MMAE) • Auristatin F-HPA (Dolasynthen) • TOPO1 inhibitor (Exatecan) • TOPO1 inhibitor (Proprietary) • Non-Pgp substrate payload • DAR 4 • DAR 6 • DAR 6 • DAR 8 • DAR 6 DLT Safe and tolerable up to 10 mg/kg (HNSTD cyno tox) 115 mg/m2 (N=2) 7.2 mg/kg (N=2) 3.2 mg/kg (N=2) 6 mg/kg (N=2) Common AEs No major toxicity observed in NHPs AST increase, Fatigue, Proteinuria, Nausea, Decreased appetite and Anemia Leukopenia, Neutropenia, Nausea, Anemia, Vomiting, Fatigue, Thrombocytopenia, Increased ALT and AST, Anorexia and Hyponatremia Nausea, Neutropenia, Thrombocytopenia, Anemia and WBC decrease Nausea, Fatigue, and Neutropenia RESPONSES • Ph1 study initiated Q1 2025 • All tumor types: 8 PR (N=26) • TNBC: 3 PR (N=13; high B7-H4 expression) • TNBC: 2 PR (N=7; ≤4 prior lines) • TNBC: 6 PR (N=16) • Ovarian: 2 PR (N=3) • Trial in progress poster (cohort 1-PROC and cohort 2- EC) presented during AACR 2025; primary completion 2026 • Ovarian 3 PR (N=7) • Breast 3 PR (N=17) • Endometrial 3 PR (N=12) All tumors 8 PR (N=39) • Ovarian (N=25) • Breast (N=16) • BTC (N=10) • Other (N=4) Data Source 2024 2023 2024 Partnership with 21 2025 Based on independent public sources and not based on direct comparisons 2025 ASCO 2025 |
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LNCB74 is More Effective than Comparator B7-H4-MMAE 22 0 10 20 30 40 0 500 1000 1500 2000 No Treatment LNCB74 (3 mg/kg) Comparator (3 mg/kg) 0 10 20 30 40 0 500 1000 1500 2000 No Treatment Comparator (4.5 mg/kg) LNCB74 (4.5 mg/kg) 0 10 20 30 40 0 500 1000 1500 2000 No Treatment LNCB74 (6 mg/kg) Comparator (6 mg/kg) 30 40 50 60 0 500 1000 1500 2000 No Treatment LNCB74 (3 mg/kg) Comparator (3 mg/kg) 30 40 50 60 0 500 1000 1500 2000 No Treatment LNCB74 (4.5 mg/kg) Comparator (4.5 mg/kg) 30 40 50 60 0 500 1000 1500 2000 No Treatment LNCB74 (6 mg/kg) Comparator (6 mg/kg) HCC1569 HER2+ BC OVCAR3 OC Comparator val-cit MMAE (B7-H4 ADC) WT hG1 Fc ↑ immune cell engagement MMAE payload (DAR4) Stochastic, reduced cystine conjugation [CTSB-cleavable, inter-chain linker] LNCB74 (B7-H4 ADC) LCB site-specific conjugation [GUSB-cleavable, light-chain linker] hG1-LALA Fc ↓↓↓ Limited immune cell engagement MMAE payload (DAR4) 8 mice / group Mean Tumor Volume (mm3) +/- SEM Days from Treatment Initiation |
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Advancing LNCB74 Development Expected Data Readout POC 1H 2026 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Backfill Cohorts ✓ ✓ 23 Dose Expansion • 4 dose cohorts • Regimen Q3W • N=65 subjects • 2 dose cohorts • 2 tumor types • N=80 subjects • Pre & on treatment biopsies Patient selection strategy Patient selection strategy Dose Escalation Dose Expansion BREAST OVARIAN ENDOMETRIAL Ph1 Dose Escalation Study Initiated January 2025 Readout: Scans every 6 weeks Endpoint: Safety & ORR ✓ |
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IMPROVED SAFETY & INCREASED EFFICACY Opportunity to Develop Differentiated B7-H4 ADC Therapeutic 24 B7-H4 ADC UNMET NEED IN BREAST & GYNECOLOGICAL CANCERS PATIENT SELECTION STRATEGY |
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25 2026 Expected Milestones & Deliverables • LNCB74 (B7-H4) POC in 1H 2026 (Breast, Ovarian, Endometrial) • SIM0505 (CDH6) POC in 1H 2026 (Ovarian, Lung, Renal) 2026 CLINICAL POC PHASE 1 CLINICAL ASSETS • B7-H4 and CDH6 ADCs • Differentiated ADCs RUNWAY • Mid-2026 |