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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):
May 24, 2024
Apogee Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its
Charter)
Delaware |
001-41740 |
93-4958665 |
(State of Incorporation or
Organization) |
(Commission File Number) |
(I.R.S. Employer Identification
No.) |
221 Crescent Street, Building 17, Suite 102b,
Waltham, MA, 02453
(Address of Principal Executive Offices, including Zip Code)
(650) 394-5230
(Registrant’s telephone
number, including area code)
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 $0.00001 per share |
|
APGE |
|
The Nasdaq Global 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 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. |
Appointment of Director
On May 24, 2024, the board of directors (the
“Board”) of Apogee Therapeutics, Inc. (the “Company”) elected Lisa L. Bollinger, M.D. to serve as a Class II
director of the Company, to hold office until the Company’s 2025 Annual Meeting of Stockholders and until her successor is duly
elected and qualified, effective May 28, 2024. The Board also appointed Dr. Bollinger to serve as a member of the Nominating
and Corporate Governance Committee of the Board.
Dr. Bollinger, age 60, is a pediatric trained
physician with over 30 years of experience in drug development, including senior level positions at the U.S. Food and Drug Administration
and multinational biotechnology and pharmaceutical companies in both regulatory affairs and pharmacovigilance. She most recently served
as the Vice President, Regulatory Affairs, Global Regulatory Affairs and Clinical Safety of Merck & Co., Inc. (NYSE: MRK),
a multinational biopharmaceutical company, from March 2021 to May 2024. Before joining Merck, Dr. Bollinger held various
positions of increasing responsibility at Amgen Inc. (Nasdaq: AMGN), a multinational biotechnology company, from September 2012 to
March 2021, most recently serving as its Vice President of Global Patient Safety & Pediatrics, and Labeling Global Regulatory
Affairs & Safety, Research and Development, from September 2018 to March 2021. Prior to Amgen, Dr. Bollinger held
various positions of increasing responsibility at the U.S. Food and Drug Administration from September 1998 to July 2012, most
recently serving as Associate Director, Office of New Drugs, Center for Drug Evaluation and Research. Dr. Bollinger received a B.S.
in Physiology from the University of California, Davis, an M.D. from Uniformed Services University of the Health Sciences F. Edward Hebert
School of Medicine and completed her residency in pediatrics at the University of California Davis Medical Center.
In connection with her appointment to the Board,
Dr. Bollinger is expected to enter into the Company’s standard form of indemnification agreement, a copy of which has been
filed as Exhibit 10.1 to the Company’s Registration Statement on Form S-1/A filed with the Securities and Exchange Commission
(“SEC”) on July 3, 2023. Dr. Bollinger will be eligible to receive cash and equity compensation in accordance the
Company’s director compensation policy as generally described under the “Director Compensation—Director Compensation
Policy” section in the Company’s definitive proxy statement filed with the SEC on April 24, 2024.
There are no arrangements or understandings between
Dr. Bollinger and any other person pursuant to which she was selected as a director of the Company. There are no family relationships
between Dr. Bollinger and any of the executive officers or directors of the Company. There is no information that is required to
be disclosed with respect to Dr. Bollinger pursuant to Item 404(a) of Regulation S-K.
Item 7.01 |
Regulation FD Disclosure. |
On May 28, 2024, the Company issued a press
release announcing Dr. Bollinger’s election to the Board. A copy of the press release is furnished as Exhibit 99.1 to
this Current Report on Form 8-K.
In accordance with General Instruction B.2 of
Form 8-K, the information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of
that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities
Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits. The following exhibit is being furnished
herewith:
EXHIBIT INDEX
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.
|
Apogee Therapeutics, Inc. |
|
|
|
Date: May 28, 2024 |
By: |
/s/ Michael Henderson, M.D. |
|
Name: |
Michael Henderson, M.D. |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
Apogee Therapeutics Expands Board of Directors
with the Appointment of Lisa Bollinger, MD
San Francisco, CA and Waltham, MA, May 28, 2024 –
Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications,
today announced that Lisa Bollinger, MD, has been appointed to the company’s board of directors. Dr. Bollinger most recently
served as Vice President, Regulatory Affairs, Global Regulatory Affairs and Clinical Safety (GRACS) at Merck, where she led the general
medicine therapeutic area in regulatory affairs. Dr. Bollinger’s over 30 years of experience in drug development, with deep
regulatory experience gained both within the U.S. FDA and multinational biotechnology and pharmaceutical companies contributed to the
Apogee board of directors’ selection decision.
“With extensive experience in the pharmaceutical and regulatory
industries, coupled with her background as a practicing pediatric physician, Lisa brings an impressive skill set to our board of directors,”
said Michael Henderson, MD, Chief Executive Officer of Apogee. “We have several exciting milestones ahead at Apogee in 2024 with
two programs now in clinical development and a third expected in the second half of the year. Lisa’s history of leading the advancement
of novel products and overseeing regulatory and safety functions will provide critical insights to our team as we advance through the
clinic and towards potential future approvals, and we are thrilled to welcome her to our board.”
“Lisa has had an impressive career in diverse functions across
the healthcare industry, making her an ideal addition to the Apogee board of directors,” said Mark McKenna, Chairman of the board
of directors. “I am looking forward to partnering with her, leveraging her unique insights into regulatory intricacies from her
time at the FDA, and clinical expertise from her pharma tenure at Merck and Amgen. This is an exciting time for Apogee, and we have built
a strong leadership team and board to lead the company through this transformative phase.”
Prior to Merck, Dr. Bollinger spent nearly 10 years with Amgen,
where she held roles of increasing responsibility, primarily focusing on global regulatory affairs and safety, with a particular focus
on pediatrics. In her most recent role, Dr. Bollinger served as Vice President, Global Patient Safety & Pediatrics, and
Labeling Global Regulatory Affairs & Safety (GRAAS), Research and Development. Before Amgen, she spent 12 years in various roles
at the U.S. Food and Drug Administration, including within the Division of Pediatric Drug Development, the Office of Counterterrorism
and the Center for Drug Evaluation and Research. For six years, she held the position of Associate Director, Office of New Drugs within
CDER and oversaw the pediatric and maternal health staff. Earlier, Dr. Bollinger spent time as a staff pediatrician at several hospitals
within the National Health Service Corp, United States Public Health Service. She also served as an Adjunct Professor of Pediatrics at
the Uniformed Services University of the Health Sciences and has published numerous books and publications. Dr. Bollinger holds an
M.D. from the Uniformed Services University of the Health Sciences F. Edward Hebert School of Medicine and a B.S. in physiology from the
University of California, Davis.
“I have been impressed by the rapid progress Apogee has made
in advancing its differentiated pipeline of programs for diseases with high unmet need, including atopic dermatitis, asthma and COPD,”
said Dr. Bollinger. “These indications involve patient populations that could greatly benefit from improved therapies with
potentially greater efficacy and less frequent dosing regimens, particularly in the pediatric population, and the pipeline lends itself
to first-in-class combination approaches. I am excited to partner with this exceptional team and board of directors to advance programs
that I strongly believe could offer a number of advantages over today’s standard of care options.”
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology
company seeking to develop differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease
(COPD), asthma and other inflammatory and immunology indications with high unmet need. Apogee’s antibody programs are designed
to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody
engineering to optimize half-life and other properties. The company’s two most advanced programs are APG777 and APG808, which are
being initially developed for the treatment of AD and COPD, respectively. Based on a broad pipeline and depth of expertise, the company
believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information,
please visit www.apogeetherapeutics.com.
Forward Looking Statements
Certain statements in this press release may constitute “forward-looking
statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: our expectations
regarding plans for our current and future product candidates and programs, and our plans for our current and future clinical trials.
Words such as “may,” “might,” “will,” “objective,” “intend,” “should,”
“could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,”
“predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar
expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these
forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based
on information available to the company on the date of this release. These forward-looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings
with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change.
Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility,
expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development
programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical
study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources;
and other risks and uncertainties identified in our Quarterly Report on 10-Q for the quarterly period ended March 31, 2024, filed
with the SEC on May 13, 2024, and subsequent disclosure documents we may file with the SEC. Apogee claims the protection of the Safe
Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any
obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by
law.
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB
dan@1abmedia.com
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