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): February 24, 2025

XERIS BIOPHARMA HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40880

87-1082097

(State or other jurisdiction of
incorporation)

(Commission
File Number)

(I.R.S. Employer
Identification No.)

1375 West Fulton Street, Suite 1300

Chicago, Illinois 60607

(Address of principal executive offices, including zip code)

(844) 445-5704

(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:

☐

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 $0.0001 per share

XERS

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

Retirement of Mr. Ken Johnson as Senior Vice President, Global Development and Medical Affairs

On February 24, 2025, Mr. Ken Johnson, Pharm.D. notified Xeris Biopharma Holdings, Inc. (the “Company”) of his decision to retire as Senior Vice President, Global Development and Medical Affairs, effective as of April 1, 2025.

Item 7.01 Regulation FD Disclosure

Appointment of Dr. Anh Nguyen as Chief Medical Officer

On February 20, 2025, the Board of Directors of the Company approved the appointment of Dr. Anh Nguyen to the newly created role of Chief Medical Officer of the Company, effective February 24, 2025.

A press release regarding the retirement of Mr. Johnson as Senior Vice President, Global Development and Medical Affairs, and the appointment of Dr. Nguyen as Chief Medical Officer is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibit 99.1, is being furnished and 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 and shall not be deemed incorporated by reference into any registration statement or other document filed pursuant to 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 Number						Description

99.1						Press Release Dated February 24, 2025

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: February 24, 2025

Xeris Biopharma Holdings, Inc.

By:

/s/ Steven M. Pieper

Name: Steven M. Pieper

Title: Chief Financial Officer

Exhibit 99.1

XERIS APPOINTS ANH NGUYEN, MD, MBA AS CHIEF MEDICAL OFFICER

Kenneth Johnson, PharmD, SVP Global Development & Medical Affairs to retire

CHICAGO, IL; February 24, 2025 – Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that Dr. Anh Nguyen has joined Xeris as Chief Medical Officer (CMO) succeeding Ken Johnson PharmD, SVP, Global Development and Medical Affairs who will retire April 1, 2025. Dr. Nguyen will develop and lead the entire product portfolio vision and strategic direction for the Medical, Regulatory, Preclinical and Clinical Development, and Pharmacovigilance functions, reporting to John Shannon, Xeris’ CEO.

“We are pleased to have Anh return to Xeris as our first Chief Medical Officer. Anh is an accomplished clinician-scientist and biopharma executive dedicated to driving advancements in regulatory strategy, clinical development, medical affairs, and commercial launches,” said John Shannon, CEO of Xeris. “He brings his forward-thinking leadership to Xeris at a time when we prepare to embark in our Phase 3 development of XP-8121 and continue to drive growth of our commercial portfolio, especially Recorlev®.”

Mr. Shannon continued, “We are fortunate that Ken has strategically played an active role in finding his successor and has graciously agreed to help and support in the transition of his organization under the new leadership of Anh. Ken’s guidance and support will undoubtedly ensure a smooth passing of the baton and set the stage for continued success of the entire Medical, Regulatory, Preclinical and Clinical Development, and Pharmacovigilance functions.”

Dr. Nguyen brings an extensive wealth of clinical and leadership experience to his role as CMO, leading the development of first-in-class therapies including circular RNA-based oncology treatments, gene-edited xenotransplants, immuno-oncology vaccines, and allogeneic CAR-T therapies. Dr. Nguyen served as Vice President and Therapeutic Sector Lead at Asklepios Biopharmaceutical (AskBio), where he directed the IND clearance and early-phase clinical trials of AAV gene therapies for neuromuscular rare disease. Among his many achievements, Dr. Nguyen shaped clinical and regulatory policies for breakthrough therapies while serving as a medical officer at the NIH, FDA, and CMS. During his Robert Wood Johnson Foundation Health Policy Fellowship serving on the US Senate HELP Committee, Dr. Nguyen was a key contributor to the landmark "21st Century Cures Act". He also led the establishment of an ambulatory surgical service to expedite pediatric orphan disease and oncology trials, earning the prestigious NIH Director's Award. During his tenure at Xeris, Dr. Nguyen served as the program medical lead for Gvoke®’s NDA and MAA approvals and multiple IND clearances for endocrine and rare disease, including novel endocrine drug co-formulations for diabetes, immunology, and pediatric epilepsy. Dr. Nguyen received an MBA from University of Chicago, a MD from Rutgers New Jersey Medical School, and completed his residency and fellowship training in anesthesiology and cardiovascular anesthesia at Massachusetts General Hospital, Harvard Medical School.

“It has been an honor to be part of an exceptionally talented team and a privilege to help lead Xeris through its evolution to a commercial-stage biopharmaceutical company,” said Ken Johnson. “I’m very proud of what we have accomplished and am confident that Dr. Nguyen will lead Xeris to new levels of success.”

“I’m excited to help lead the scientific efforts at Xeris, to collaborate and usher a new era of transformative therapies that leverage our innovation and strategic partnerships, to redefine patient care,” said Dr. Nguyen.

About Xeris

Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners.

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc., including the development of its product portfolio vision and strategy for its internal functions, the potential growth of its commercial portfolio, and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

Investor Contact

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

awey@xerispharma.com

Cover	Feb. 24, 2025
Document Information [Line Items]
Document Type	8-K
Document Period End Date	Feb. 24, 2025
Entity Registrant Name	XERIS BIOPHARMA HOLDINGS, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-40880
Entity Tax Identification Number	87-1082097
Entity Address, Address Line One	1375 West Fulton Street,
Entity Address, Address Line Two	Suite 1300
Entity Address, City or Town	Chicago
Entity Address, State or Province	IL
Entity Address, Postal Zip Code	60607
City Area Code	844
Local Phone Number	445-5704
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 $0.0001 per share
Trading Symbol	XERS
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Amendment Flag	false
Entity Central Index Key	0001867096