Form 8-K - Current report

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): January 9, 2024

Akoya Biosciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40344	47-5586242
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

100 Campus Drive, 6th Floor

Marlborough, MA
(Address of principal executive offices)

01752
(Zip Code)

(855) 896-8401

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K 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:

Title of each class		Trading Symbol		Name of each exchange on which registered
Common stock, par value $0.00001 per share		AKYA		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 x

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On January 9, 2024, Dr. Garry Nolan, Ph.D., notified Akoya Biosciences, Inc. (the “Company”) of his resignation as a member of the Board of Directors (the “Board”) of the Company, including all committees thereof, effective as of such date. Dr. Nolan’s resignation was not the result of any dispute or disagreement with the Company or the Board on any matter relating to the operations, policies or practices of the Company.

Item 7.01 Regulation FD.

On January 10, 2024, the Company issued a press release announcing the formation of a Scientific Advisory Board of the Company, which initially includes Dr. James Allison, Dr. Padmanee Sharma and Dr. Nolan, with Dr. Nolan serving as Chair. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in Item 7.01 of this Current Report on Form 8-K, including the press release furnished as Exhibit 99.1 hereto, is being furnished and shall not be deemed “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 it be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description of Exhibits
99.1		Press Release, dated January 10, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 10, 2024	Akoya Biosciences, Inc.

	By:	/s/ Brian McKelligon
		Brian McKelligon
		Chief Executive Officer

Exhibit 99.1

Akoya Biosciences Announces that Garry Nolan, Ph.D., James Allison, Ph.D., and Padmanee Sharma, M.D., Ph.D., Join Newly Created Scientific Advisory Board

Leading immunotherapy and immunobiology experts will offer strategic direction and expertise in translational, clinical, and diagnostic applications of Akoya’s spatial biology solutions

MARLBOROUGH, Mass. (GLOBE NEWSWIRE) January 10, 2024 -- Akoya Biosciences, Inc., (NASDAQ: AKYA), The Spatial Biology Company^®, today announced the establishment of its Scientific Advisory Board (SAB) to provide strategic guidance and consult on the Company's efforts to deliver spatial biology solutions for the life sciences industry, from discovery to diagnostics.

The initial members of Akoya’s Scientific Advisory Board are:

•

Garry Nolan, Ph.D., Rachford and Carlota A. Harris Professor in the Department of Pathology at Stanford University School of Medicine, co-founder of Akoya Biosciences and inventor of the CODEX technology (now PhenoCycler)

•

James Allison, Ph.D., Regental Professor and Chair of the Department of Immunology, the Olga Keith Wiess Distinguished University Chair for Cancer Research, and Director of the James P. Allison Institute at The University of Texas MD Anderson Cancer Center; recipient of the 2018 Nobel Prize in Physiology or Medicine

•

Padmanee Sharma, M.D., Ph.D., Professor in the Departments of Genitourinary Medical Oncology and Immunology, Associate VP of Immunobiology, the T.C. and Jeanette D. Hsu Endowed Chair in Cell Biology, and Director of Scientific Programs for the James P. Allison Institute at MD Anderson

"Our SAB includes leaders in immunotherapy, immunobiology and innovation with deep knowledge and experience in translational research, the discovery of ground-breaking clinical therapies and the development of disruptive and high impact technologies," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "By bringing together experts with unparalleled track records of success, the SAB will enable us to better serve customer needs, accelerate our leadership position in spatial biology, and support Akoya’s mission to catalyze discovery and improve patient care."

Garry Nolan, Ph.D.

Professor Nolan will transition from his role on the Akoya Board of Directors to Chair of the SAB. He co-founded Akoya Biosciences in 2015 and is the Rachford and Carlota A. Harris Professor in the Department of Pathology at Stanford University School of Medicine. As a co-inventor of the CODEX technology, Garry has focused his research efforts on developing novel technologies and computational methods for research into cancer, leukemia, immunology, and autoimmune disease. Professor Nolan was the founder of a number of life sciences companies in addition to Akoya, including Rigel Inc. (NASDAQ: RIGL), DVS Sciences (purchased by Fluidigm), Nodality, Inc., BINA (sold to Roche Diagnostics), Apprise (sold to Roche Sequencing Solutions), Scale Bio (single cell ATAC, RNA, and protein), and serves as an advisor and board member for several biotechnology companies. He has published over 350 research articles and is the holder of 50 US patents and has been honored as one of the top 25 inventors at Stanford University. He trained with Leonard Herzenberg (for his Ph.D.) and Nobelist Dr. David Baltimore for postdoctoral work. Professor Nolan is the first recipient of the Teal Innovator Award (2012) from the Department of Defense and has been honored with a number of awards including Nature Publishing “Outstanding Research Achievement”, Stohlman Scholar from the Leukemia and Lymphoma Society and Burroughs Wellcome Fund New Investigator Award.

James Allison, Ph.D.

Dr. Allison has spent a distinguished career studying the regulation of T cell responses and developing strategies for cancer immunotherapy. He earned the 2018 Nobel Prize in Physiology or Medicine, which he shared with Dr. Tasuku Honjo, "for their discovery of cancer therapy by inhibition of negative immune regulation." Among his most notable discoveries are the determination of the T cell receptor structure and that CD28 is the major costimulatory molecule that allows full activation of naïve T cells and prevents anergy in T cell clones. His lab resolved a major controversy by demonstrating that CTLA-4 inhibits T-cell activation by opposing CD28-mediated costimulation and that blockade of CTLA-4 could enhance T cell responses, leading to tumor rejection in animal models. This finding and a great deal of persistence paved the way for the field of immune checkpoint blockade therapy for cancer. Work in his lab led to the development of ipilimumab, an antibody to human CTLA-4 and the first immune checkpoint blockade therapy approved by the FDA. Among many honors, he is a member of the National Academies of Science and Medicine and received the Lasker-Debakey Clinical Medical Research award in 2015. His current work seeks to improve immune checkpoint blockade therapies currently used to identify new targets to unleash the immune system in order to eradicate cancer.

Padmanee Sharma, M.D., Ph.D.

Dr. Sharma has written and conducted multiple innovative immunotherapy clinical trials, with an emphasis on obtaining patients’ tumor samples for in-depth laboratory studies, including the first neoadjuvant trial with immune checkpoint therapy and first clinical trial with immune checkpoint therapy for patients with bladder cancer. Her studies have identified novel resistance mechanisms to immune checkpoint therapy, including loss of interferon (IFN) signaling, VISTA⁺ immunosuppressive cells, increased EZH2 expression in T cells, TGFβ signaling in bone metastases, and CD73⁺ myeloid cells in GBM. These data have led to initiation of new research studies focused on developing rational combination immunotherapy strategies for the treatment of cancer patients. As a result of her outstanding contributions to the field of cancer immunotherapy, Dr. Sharma was selected as a member of the American Society for Clinical Investigation (ASCI) and was awarded the Emil Frei III Award for Excellence in Translational Research in 2016, the Coley Award for Distinguished Research for Tumor Immunology in 2018, the Women in Science with Excellence (WISE) Award in 2020, the Heath Memorial Award in 2021 and the Randall Prize for Excellence in Cancer Research in 2021.

Disclosure

Dr. Allison and Dr. Sharma receive financial and equity compensation as members of Akoya’s SAB, and these financial relationships have been disclosed to MD Anderson’s Conflict of Interest Committee in accordance with institutional policy.

Forward-Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our expectations about the potential of our products and services, our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, our ability to execute on our plans and expectations, our future performance and other matters regarding our business strategies and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

About Akoya Biosciences

As The Spatial Biology Company^®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler^®, PhenoImager^® Fusion and PhenoImager HT Instruments. To learn more about Akoya, visit www.akoyabio.com.

Akoya Biosciences Investor Contact

Priyam Shah

Sr. Director, Investor Relations

investors@akoyabio.com

Akoya Biosciences Media Contact:

Christine Quern

(617) 650-8497

media@akoyabio.com

Cover	Jan. 09, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 09, 2024
Entity File Number	001-40344
Entity Registrant Name	Akoya Biosciences, Inc.
Entity Central Index Key	0001711933
Entity Tax Identification Number	47-5586242
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	100 Campus Drive
Entity Address, Address Line Two	6th Floor
Entity Address, City or Town	Marlborough
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01752
City Area Code	855
Local Phone Number	896-8401
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, par value $0.00001 per share
Trading Symbol	AKYA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false