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): March 29, 2021
INMUNE BIO INC. | ||
(Exact name of registrant as specified in charter) |
Nevada | 001-38793 | 47-5205835 | ||
(State or other jurisdiction | (Commission File Number) | (IRS Employer | ||
of incorporation) | Identification No.) |
1200 Prospect Street, Suite 525, La Jolla, CA 92037
(Address of Principal Executive Offices) (Zip Code)
(858) 964 3720
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(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:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, par value $0.001 per shares | INMB | The NASDAQ Stock Market LLC |
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 mart 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.
On March 29, 2021, INmune Bio Inc. (the “Company”), entered into financial advisory agreement with National Securities Corporation (“National”). Pursuant to the Agreement, National will provide, on a non-exclusive basis, such financial and other advisory services, as the Company may reasonably request and National deems necessary or appropriate in connection with the Agreement. National shall in the course of the engagement: organize ‘non-deal’ roadshows each comprising presentations to retail offices and institutional investors; provide access to National Securities’ Biotechnology Research Analyst for discussions about the strategy and positioning of the Company; provide access to National Securities’ professional staff for discussions relating to investor relations strategies; and assist in the preparation and dissemination of information regarding the Company and its activities and prospects, including, but not limited, to investor kits and presentations to retail and institutional investors, with the goal of promoting increased name recognition for the Company and familiarity with the Company’s business model, activities and strategies. The Agreement is for a period of 12 months and National shall be paid a fee of $91,666 per month.
Item 8.01. Other Events.
The Company is filing as Exhibit 99.1 to this Current Report on Form 8-K an slide deck that the Company intends to use in a presentation.
By filing this Current Report on Form 8-K and furnishing the information
contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be
disclosed solely by reason of Regulation FD.
The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company's Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
Exhibit Number | Description | |
10.1 | Form of agreement between INmune Bio Inc. and National Securities Corporation, dated March 29, 2021 | |
99.1 | Presentation |
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.
INMUNE BIO INC. | ||
Date: March 29, 2021 | By: | /s/ David Moss |
David Moss | ||
Chief Financial Officer |
Exhibit 10.1
FINANCIAL ADVISORY ENGAGEMENT AGREEMENT
March 29, 2021
Mr. David Moss
Chief Financial Officer
INmune Bio, Inc.
1200 Prospect Street, Suite 525
La Jolla, CA 92037
Dear David
National Securities, Corp. (“National”) is pleased to provide on a non-exclusive basis financial advisory and investor relations services to INmune Bio, Inc. (the “Company”) with respect to 1) advising the company on ways to optimize their available financial alternatives including but not limited to the potential solicitation of new investors 2) strategic introductions, potential joint venture opportunities and assisting the Company in developing a well-coordinated and integrated plan to address ways in which the Company can seek to increase its visibility within its markets, enhance its liquidity and establish non deal roadshows and 3) any other general advisory services that the Company may seek to pursue and avail themselves of on the terms and conditions in this letter agreement (the “Agreement”).
1. Engagement; Nature of Services.
(a) The Company engages National as the Company’s non-exclusive financial advisor to render such financial and other advice as an investment banker, as the Company may reasonably request and National deems necessary or appropriate in connection with the Agreement.
(b) National shall in the course of the Engagement:
· | Organize ‘non-deal’ roadshows each comprising presentations to retail offices and institutional investors; |
· | Provide access to National Securities’ Biotechnology Research Analyst for discussions about the strategy and positioning of the Company; |
· | Provide access to National Securities’ professional staff for discussions relating to the Company’s investor relations strategy ; and |
· | Assist in the preparation and dissemination of information regarding the Company and its activities and prospects, including, but not limited, to investor kits and presentations to retail and institutional investors, with the goal of promoting increased name recognition for the Company and familiarity with the Company’s business model, activities and strategies. |
(c) National shall render such other services as may from time to time be agreed upon by National and the Company (e.g., fairness opinions, business plans). The fees payable for any such other services shall be customary fees to be mutually agreed upon in advance and based upon the nature and type of the services to be rendered.
(d) National shall not be required to undertake duties not reasonably contemplated by this Agreement or to spend any minimum amount of time in providing such services. National does not provide tax, accounting or legal advice. Any public offerings shall be subject to a separate agreement and are expressly not addressed in this Agreement
2. Information.
The Company will furnish to National such information as National reasonably requests in connection with performing its services. In performing its services, National will use and rely upon the information furnished by the Company as well as publicly available information regarding the Company. Accordingly, National shall be entitled to assume and rely upon the accuracy and completeness of all h information prepared by the Company and is not required to independently verify any such information, whether publicly available or otherwise furnished to it, including any financial information, forecasts or projections. For any financial forecasts and projections made available to National by the Company, National may assume that the forecasts and projections have been reasonably prepared on bases reflecting the best currently available estimates and judgment of management of the Company.
In the event the Company makes available to National certain information concerning the business, financial condition, operations, assets and liabilities of the Company and other proprietary information of the Company or its affiliates (“Confidential Information”) in connection with the performance of its duties hereunder National agrees to treat such Confidential Information (whether prepared by the Company, its advisors, affiliates, investors or otherwise and irrespective of the form of communication) which is furnished to National or to its employees or agents now or in the future by or on behalf of the Company as confidential and to hold it in confidence in accordance with the provisions of this Agreement, and to take or abstain from taking certain other actions hereinafter set forth. Confidential Information also shall be deemed to include all notes, analyses, compilations, studies, interpretations or other documents prepared by National, its employees or agents which contain, reflect or are based upon, in whole or in part, Confidential Information furnished to National, its employees or agents pursuant hereto. The term Confidential Information does not include information which (i) is or becomes generally available to the public other than as a result of a disclosure by National, its employees or agents, or (ii) becomes available to National on a non-confidential basis from a source other than the Company or its affiliates (including without limitation any of the Company’s or its affiliates directors, officers, employees or agents), or any of its attorneys, accountants, investors, consultants, bankers and financial advisors (collectively, the “Representatives”), provided that such source is not bound by a confidentiality agreement with or other contractual, legal or fiduciary obligation of confidentiality to the Company, its affiliates or any other party with respect to such information.
National hereby agrees that National, its employees and agents shall use the Confidential Information solely for the purposes contemplated by this Agreement.
3. Fees.
For the services to be rendered by National, the Company shall pay to National or its designees, the Fees set forth below.
i. | The Company shall provide to National a cash fee equal to $1,100,000 for its proposed services. The cash fee shall be payable on a monthly basis over a twelve (12) month period with the initial payment due March 30, 2021. |
ii. | Upon execution of this Agreement, the Company shall provide to National pre-paid expense reimbursement equal to $8,000 for expenses related to the proposed services. |
4. Scope of Responsibility.
National shall not be liable to the Company, or to any other person claiming through the Company, for any claim, loss, damage, liability, or expense suffered by the Company or any such other person arising out of or related to National’s engagement except for any claim, loss, damage, liability or expense that arises out of, or is based upon, any action or failure to act by National that constitutes bad faith, willful misconduct, breach of applicable law or regulations or gross negligence.
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5. Indemnification; Contribution.
(a) The Company agrees to indemnify and hold harmless National and its officers, directors, shareholders, employees, affiliates, agents and each person who controls National (and any of its affiliates) within the meaning of Section 15 of the Securities Act of 1933, as amended or Section 20 of the Securities Exchange Act of 1934, as amended (each an “Indemnified Person”), to the fullest extent lawful, against any and all losses, damages, liabilities, and expenses (including all fees and disbursements of counsel and other expenses) (“Damages”) reasonably incurred in connection with the investigation of, preparation for and defense of any pending or threatened claim, action, proceeding, inquiry, investigation or litigation, to which an Indemnified Person may become subject (collectively, “Claims”) that arises out of or is related to National’s engagement under this Agreement. However, this indemnification shall not include any Damages that are found in a final judgment by a court of competent jurisdiction to have resulted from the bad faith, willful misconduct, breach of applicable law or regulation or gross negligence of any Indemnified Person.
(b) If the indemnity above is unavailable or insufficient to hold harmless an Indemnified Person, then the Company shall contribute to amounts paid or payable by an Indemnified Person for Damages in such proportion as appropriately reflects the relative benefits received by the Company on the one hand and National on the other. If applicable law does not permit allocation solely on the basis of benefits, then such contribution shall be made in such proportion as appropriately reflects both the relative benefits and relative fault of the parties and other relevant equitable considerations. However, in no event shall National’s aggregate contributions for Damages exceed the amount of fees actually received by National under this Agreement except to the extent that such Damages were incurred due to the bad faith, willful misconduct, breach of applicable law or regulation or gross negligence of National. The relative benefits to the Company and National of this Agreement shall be deemed to be in the same proportion that the total value paid or received or contemplated to be paid or received by the Company or its security holders resulting from this Agreement bears to the fees paid to National under this Agreement.
(c) Promptly after receipt by National of notice of any claim or the commencement of any action for which an Indemnified Person may be entitled to indemnity, National shall promptly notify the Company of such claim or the commencement of such against the Indemnified Person that would give rise to indemnification. However, any delay or failure to notify the Company will not relieve the Company of its indemnity obligation except to the extent it is materially prejudiced by such delay or failure. The Company may participate in the defense of the claim and shall assume the defense of the claim and shall pay as incurred the fees and disbursements of counsel for the proceeding. In any proceeding where the Company declines to assume the defense or the Company’s counsel is deemed to have a conflict of interest, the Indemnified Person shall have the right to retain its own counsel which shall be reasonably satisfactory to National. The Company shall pay the fees and expenses of such counsel as incurred. However, the Company shall not be responsible for the fees and expenses of more than one counsel (other than counsel of record) for all Indemnified Persons.
(d) The Company will not enter into any waiver, release or settlement for any threatened or pending claim, action, proceeding or investigation or settle any related litigation for which indemnification may be sought under this Agreement by an Indemnified Party , without the written consent of the Indemnified Party unless the waiver, release or settlement includes an unconditional release of each Indemnified Person from any and all liability arising out of the threatened or pending claim, action, proceeding, investigation or litigation.
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6. Term; Termination of Engagement.
The term of this engagement shall be for six (6) months from the date of this Agreement. Nevertheless, National’s engagement may be terminated by either the Company or National at any time upon written notice to that effect to the other party.
The provisions of this Section 7 and of Sections 3, 4, 5 and 6 of this Agreement shall survive termination.
7. Representations and Warranties; Covenants.
The Company represents, warrants and covenants as follows:
(a) All information provided by the Company will be accurate and complete in all material respects and will not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in light of the circumstances under which such statements are made.
(b) During the term of this Agreement, the Company will (a) provide copies of its annual reports and other financial reports not publicly available at the earliest time the Company makes them available to others, and (b) provide such other information concerning the business and financial condition of the Company and its assets as National may from time to time reasonably request.
(c) The execution, delivery and performance of this Agreement and the consummation of the transactions contemplated in this Agreement have been duly authorized by all necessary corporate action and will not conflict with or constitute a breach of, or default under, or result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company pursuant to, any contract, indenture, mortgage, loan agreement, note, lease or other instrument to which the Company is bound, or to which any property or assets of the Company are subject.
8. Reliance on Others. The Company confirms that it will rely on its own counsel and accountants for legal, tax and accounting advice.
9. No Rights in Shareholders, etc. National has been engaged only by the Company, and this engagement is not deemed to be on behalf of and is not intended to confer rights upon any shareholder, partner or other owner of the Company or any other person not a party to this Agreement as against National. Unless otherwise expressly agreed, no one other than the Company is authorized to rely upon this engagement of National or to rely upon any statements, advice, opinions or conduct by National.
10. Independent Contractor; No Fiduciary Duty; Non-Exclusive Services: National’s role is that of an independent contractor and nothing in this Agreement is intended to create or shall be construed as creating a fiduciary or agency relationship between the Company and National. National and its affiliates provide financial advisory services, investment banking services, and consulting advice to others. Nothing in this Agreement shall limit or restrict National in providing services to others, except as such services may relate to matters concerning the Company’s business and properties.
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11. National acknowledges that the Company is a public company whose stock is listed on the NASDAQ stock exchange. Accordingly, National agrees that each of its officers, directors, employees, representatives and agents that is in possession of material non-public information of the Company or any affiliate of the Company shall abide by the federal securities laws and regulations of the United States of America which prohibit trading in the securities of any company while in possession of material non-public information and to not disclose such information to others who might trade on it. “Material information” is generally defined as any information about the subject company or the market for that company’s securities which would (i) likely affect the price of those securities, or (ii) likely be considered important by reasonable investors, including reasonable speculative investors, in determining whether to trade in the securities of such company. “Non-public information” is generally defined as information which has not been disclosed generally or is otherwise generally known in the marketplace.
12. Governing Law; Jurisdiction. This Agreement shall be governed by and construed in all respects under the laws of the State of New York, without reference to its conflict of laws provisions. Any right to trial by jury for any claim, action, proceeding or litigation arising out of this Agreement or any of the matters contemplated in this Agreement is waived by the Company and National. The parties hereby irrevocably and unconditionally: submit to the jurisdiction of the federal and state courts located in the State of New York, for any dispute related to this Agreement or any of the matters contemplated hereby; consent to service of process by registered or certified mail return receipt requested or by any other manner provided by applicable law; and waive any right to claim that any action, proceeding or litigation so commenced has been commenced in an inconvenient forum.
13. Miscellaneous. Nothing in this Agreement is intended to obligate National to provide any services other than as set forth above. This Agreement may be executed in counterparts, each of which shall be deemed an original, but which together shall be considered a single instrument. This Agreement constitutes the entire agreement between the parties, and supersedes all prior agreements and understandings (both written and oral) of the parties with respect to the subject matter of this Agreement. This Agreement cannot be amended or otherwise modified except in writing signed by the parties. The provisions of this Agreement shall inure to the benefit of and be binding upon the successors and assigns of the Company and National.
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If you agree with the foregoing, please sign both copies of this letter, retain one copy for your records and return the other copy to us, whereupon the Agreement shall become effective as of March 15, 2021.
Sincerely,
National Securities Corporation | ||
By: | ||
Name: | Jonathan C. Rich | |
Title: | EVP – Head of Investment Banking | |
ACCEPTED AND AGREED: | ||
INmune Bio, Inc. | ||
By: | ||
Name: | David Moss | |
Title: | Chief Financial Officer | |
By: | ||
Name: | Raymond J. Tesi | |
Title: | Chief Executive Officer |
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Exhibit 99.1
Professor Mark W Lowdell CSO 1 “Exploring the cellular interactions between NK cells, tumor cells and the TME”
Tumor - derived Inhibitory signals Activating signals Tumor - derived Inhibitory signals Activating signals Tumor - derived Inhibitory signals Activating signals Activating signals Activating signals NK - Tumor TROGOCYTOSIS NK - NK interactions % of conjugates NK-NK cells 0 20 40 60 80 0.0 0.5 1.0 1.5 2.0 NK:K562[1:5] NK:K562[1:1] NK:K562[5:1] Time[min] % of conjugates
• Balance of signals – Tumor “sensitivity” • NK:tumor cell ratio • NK cell subset • Prior exposure? – TiM - NK – CiM - NK • Inhibitory microenvironment What determines the outcome of NK - tumor ligation? CD15 - ve K562 NK resistant rNK cell X rNK lack enough activating signals to overcome tumor inhibition
E:T determines outcome Low E:T ratios = High NK activation and degranulation – Low lysis CD107a expression on NK cells K 5 6 2 I N B 1 6 0 20 40 60 80 rNK NK+Target[1:2] NK+Target[2:1] NK+Target[5:1] NK+Target[10:1] % o f e x p r e s s i o n CD69 expression on NK cells K 5 6 2 I N B 1 6 0 20 40 60 80 rNK NK+Target[1:2] NK+Target[2:1] NK+Target[5:1] NK+Target[10:1] % o f e x p r e s s i o n NK mediated lysis K 5 6 2 I N B 1 6 0 20 40 60 80 100 NK+Target[1:2] NK+Target[2:1] NK+Target[5:1] NK+Target[10:1] % o f s p e c i f i c l y s i s CD69 expression after 4h on NK subpopulations rNK NK:INB16 [1:2]NK:INB16 [2:1]NK:INB16 [5:1]NK:INB16 [10:1] 0 20 40 60 80 100 CD107a(-) with monensin CD107a(+) with monensin CD107a(-) w/o monensin CD107a(+) w/o monensin % of expression
Prior exposure to tumor cells may impair or enhance tumor killing Priming effect % of expression on NK cells TNFa IFNy Perforin GranzymeB 0 5 10 15 50 60 70 80 90 100 rNK NK+K562 [1:2] NK+INB16 [1:2] % of expression
NK - NK activation following trogocytosis C D 6 9 0 20 40 60 rNK +TpNK +IL15[1ng/mL] % r N K r e c e p t o r e x p r e s s i o n +TpNK(1:10)+IL15 rNK priming by TpNK
CD107a expression on NK cells r N K N K + [ K 5 6 2 ] N K + [ K 5 6 2 2 4 h ] N K + [ K 5 6 2 l y s a t e s ] N K + [ I N B 1 6 ] N K + [ I N B 1 6 2 4 h ] N K + [ I N B 1 6 l y s a t e s ] 0 20 40 60 80 % o f e x p r e s s i o n Killing assay for Raji cells r N K + T a r g e t N K + [ K 5 6 2 ] + T a r g e t N K + [ K 5 6 2 2 4 h ] + T a r g e t N K + [ K 5 6 2 l y s a t e s ] + T a r g e t N K + [ I N B 1 6 ] + T a r g e t N K + [ I N B 1 6 2 4 h ] + T a r g e t N K + [ I N B 1 6 l y s a t e s ] + T a r g e t 0 20 40 60 80 % o f s p e c i f i c l y s i s NK cells are activated by tumor cell membranes but do not express CD69 or degranulate Expression on NK cells C D 6 9 C D 1 6 0 20 40 60 80 100 rNK NK+[K562] NK+[K562 24h] NK+[K562 lysates] NK+[INB16] NK+[INB16 24h] NK+[INB16 lysates] % o f e x p r e s s i o n
Does tumor exposure influence NK avidity? Kushal Kumar Das - Lumicks Acoustic Node Glass 0.1mm Piezo Element Target tumor cells Primed vs Resting NK cells Ultrasound is used to exert forces completely contactless to NK cells in a microfluidic chip
CD107a expression on NK cells rNK NK+K562[1:2]NK+INB16[1:2] 0 20 40 60 80 100 % of expression Killing assay: % of specific lysis (after 4h) NK+K562 [5:1] NK+INB16 [5:1] 0 20 40 60 80 100 % of specific lysis
Data by Amanda van Vliet CAR - NK Mock - NK 90% lysis 30% lysis
CD107a expression on NK cells rNK NK+K562[1:2]NK+INB16[1:2] 0 20 40 60 80 100 % of expression Killing assay: % of specific lysis (after 4h) NK+K562 [5:1] NK+INB16 [5:1] 0 20 40 60 80 100 % of specific lysis E:T [1:1] 15min 30min 45min 60min 0 5 10 rNK TpNK LAK % of conjugates
Alive >2yrs % K562 lysis NK function only needs to be “adequate”
Effects of hypoxia may be transient and tumor cell dependent 4 6 16 0 20 40 60 80 100 NK NK (hyp) Time (h) S p e c i f i c C y t o l y s i s ( % ) K562 + rNK RAJI +LAK15 4 6 16 24 48 0 20 40 60 80 100 Time (h) S p e c i f i c C y t o l y s i s ( % ) NK+IL15(10ng/ml) NK+IL15(10ng/ml (hyp) 4 6 16 24 48 0 20 40 60 80 100 Time (h) S p e c i f i c C y t o l y s i s ( % ) NK NK (hyp) OVCAR3 + rNK OVCAR3 +LAK15 4 6 16 0 20 40 60 80 100 Time (h) S p e c i f i c C y t o l y s i s ( % ) Raji+TpNK Raji+TpNK (hyp) 4 6 16 0 20 40 60 80 100 Time (h) S p e c i f i c C y t o l y s i s ( % ) Raji+NK+IL-15 (10ng) O/N Raji+NK+IL-15 (10ng) O/N (hyp) 4 6 16 24 48 0 20 40 60 80 100 Time (h) S p e c i f i c C y t o l y s i s ( % ) TpNK TpNK (hyp) OVCAR3 + TpNK RAJI + TpNK
Effects of inhibitory cells in the TME Myeloid - derived suppressor cells Treg Suppression of MLR T r e g : T c o n v 1 : 2 T r e g : T c o n v 1 : 4 T r e g : T c o n v 1 : 8 T r e g : T c o n v 1 : 1 6 T r e g : T c o n v 1 : 3 2 0 20 40 60 80 % o f s u p p r e s s i o n S p e c i f c i c y t o l y s i s N K + R A J I N K + T r e g + R A J I N K + I L 2 1 0 0 I U + R A J I N K + T r e g + I L 2 1 0 0 I U + R A J I T p N K + R A J I T p N K + T r e g + R A J I 0 20 40 60 80 100 Treg Suppression of NK-mediated lysis K562 lysis 5:1:1 0 20 40 60 80 100 rNK rNK:CD33 (IL-6) Allo 1 rNK:CD33 (VEGF) Allo 1 rNK:CD33 (IL-6) Allo 2 rNK:CD33 (VEGF) Allo 2 rNK:CD33 (IL-6) Auto rNK:CD33 (VEGF) Auto % o f s p e c i f i c l y s i s K562 lysis 5:1:1 0 10 20 30 40 % C D 1 0 7 a + Allo 1 Allo 2 AutoNIL
Conclusions • NK:tumor cell interactions are multicellular and multifactorial • Degranulation is not a direct correlate of lysis and thus not of exhaustion • Tumor cell conjugation may induce activation without lysis and generate a primed state associated with increased TNF - a and IFN - g and increased avidity to secondary tumor targets • Classical regulatory factors in the TME can inhibit NK function in vitro but the effects are transient and may be overcome by appropriate activating signals • Increased avidity enhances lysis but not conjugation duration and may be a tool to develop, screen and qualify novel NK activating agents • The molecular basis of increased avidity is being dissected
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