エドガーで原本を確認する
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 1, 2025
CATALYST PHARMACEUTICALS, INC.
(Exact Name Of Registrant As Specified In Its Charter)
| Delaware | 001-33057 | 76-0837053 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
||
| 355 Alhambra Circle | ||||
| Suite 801 | ||||
| Coral Gables, Florida | 33134 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (305) 420-3200
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 |
Name of Exchange on Which Registered |
Ticker Symbol |
||
| Common Stock, par value $0.001 per share | NASDAQ Capital Market | CPRX |
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 8.01 | Other Events |
On June 1, 2025, Gary Ingenito, MD, PhD, the Chief Medical and Regulatory Officer of Catalyst Pharmaceuticals, Inc. (the “Company”) retired from his position. Dr. Ingenito reported to the Company that his decision to retire was not the result of any disagreements between Dr. Ingenito, on the one hand, and the Company, the Company’s management, or the Company’s Board of Directors, on the other hand, as to any matter relating to the Company’s operations, finances, policies, or practices. Dr. Ingenito will continue to serve as a consultant to the Company following his retirement in order to assist the Company in a smooth transition.
On June 2, 2025, William (Will) Andrews, MD, FACP joined the Company as its new Chief Medical Officer. Dr. Andrews is an executive leader with 25 years of global biopharmaceutical experience in clinical development, medical affairs, medical/commercial strategy, and business development. Dr. Andrews’s executive responsibilities have also included drug safety/pharmacovigilance, clinical operations, biometrics and data management, regulatory affairs, and alliance management. He has worked with both drugs and biologics across multiple therapeutic areas and through all phases of development. He has worked on multiple NDAs and global submissions and has co-led seven therapeutic launches. His primary area of expertise is in rare disease, having spent close to 20 years in this space. Prior to joining Catalyst, since 2023, Dr. Andrews served as CEO and President of Lighthouse Bio, a start-up focused on identification, assessment, and acquisition of rare disease therapeutic assets for new company formation. Prior to Lighthouse Bio, Dr. Andrews was Principal of Aletheia Lifesciences, a biopharmaceutical consultancy, during which he served as Acting CMO of a platform company developing AI-enabled precision medicines for rare diseases. From 2021 to 2022, Dr. Andrews served as Chief Medical Officer of Flexion Therapeutics, a biopharmaceutical company, where he led clinical research and development programs, drug safety/pharmacovigilance, biostatistics, and medical affairs until Flexion’s acquisition by Pacira Biosciences. Prior to that position, from 2020 to 2021, Dr. Andrews served as Chief Medical Officer of Akcea Therapeutics, a global biopharmaceutical company focused on the development and commercialization of anti-sense oligonucleotides for rare diseases, until Akcea’s acquisition by Ionis Pharmaceuticals. From 2017 to 2020, Dr. Andrews served as Chief Medical Officer of Acer Therapeutics, a development and commercialization company focused on rare, metabolic and cardiovascular diseases. Prior to his initial work with Acer Therapeutics, from 2016-2017, Dr. Andrews served first as Vice President, Medical Affairs and later as Senior Vice President, Business Development, for Aegerion Pharmaceuticals, from 2012-2016. Prior to that, Dr. Andrews served as (i) Vice President, Medical Affairs and Senior Research Physician, Clinical Development for Santhera Pharmaceuticals, from 2008-2011; (ii) in positions of increasing responsibility as Medical Director, then Senior Medical Director and then as Executive Medical Director, Medical Affairs with Sepracor (now Sunovion Pharmaceuticals), from 2003 to 2008; and (iii) as Medical Director of Clinquest, from 2001 to 2003. Dr. Andrews practiced internal medicine full time in Boston, MA, from 1994 to 2001, and part-time from 2001-2012. He served as an attending physician at Brigham and Women’s Hospital and as Clinical Faculty at Harvard Medical School. Dr. Andrews received his A.B. in Biology from Harvard University and his MD from Yale University School of Medicine.
On June 2, 2025, the Company issued a press release announcing Dr. Ingenito’s decision to retire and Dr. Andrews’s appointment as the Company’s new Chief Medical Officer. A copy of the Company’s press release reporting these matters is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
2
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| 99.1 | Press release issued by the Company on June 2, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Catalyst Pharmaceuticals, Inc. | ||
| By: | /s/ Michael W. Kalb |
|
| Michael W. Kalb | ||
| Executive Vice President and Chief Financial Officer | ||
Dated: June 2, 2025
4
Exhibit 99.1
Catalyst Pharmaceuticals Announces Appointment of William T. Andrews, MD, FACP as Chief Medical Officer
Gary Ingenito, MD, PhD is retiring from Catalyst after a successful career
CORAL GABLES, Fla., June 2, 2025 - Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX) today announced the appointment of William (Will) T. Andrews, MD, FACP as Chief Medical Officer. Dr. Andrews will report directly to the Company’s President and Chief Executive Officer, Richard J. Daly, and will serve as a member of the Company’s executive leadership team. He succeeds Dr. Gary Ingenito, who is retiring after a successful career and will support the transition in a consulting capacity.
“We are pleased to welcome Dr. Andrews to Catalyst. In addition to his foundational work in clinical practice in some of the country’s most prestigious hospitals, he brings significant experience in biopharmaceuticals to this role,” said Richard J. Daly, President and Chief Executive Officer, Catalyst. “This is an exciting time to join Catalyst as we work to continue our exceptional financial performance that underscores the strength of our commercial strategy and the growing demand for our differentiated therapies that help patients live healthier lives.”
Dr. Andrews brings 24 years of global biopharmaceutical experience across clinical development, medical affairs, corporate strategy and transactions, medical and commercial strategy and business development to Catalyst. Dr. Andrews has worked with both drugs and biologics across multiple therapeutic areas and through all phases of development. His primary area of expertise is in rare diseases, having spent 18 years in this space. Since 2023, Dr. Andrews was the President, CEO and co-founder of Lighthouse Bio, a biopharmaceutical start-up focused on rare disease asset acquisition with the goal of new company formation. Prior to Lighthouse Bio, he was the principal and founder of Aletheia Lifesciences, a biopharmaceutical consultancy that delivered corporate strategic as well as clinical and medical consulting. Before founding Aletheia, Dr. Andrews served as a Chief Medical Officer for Flexion Therapeutics, Akcea Therapeutics and Acer Therapeutics, as well as serving in roles of increasing responsibility at various other biopharmaceutical organizations.
Dr. Andrews began his career in clinical practice with Harvard Vanguard Medical Associates and Brigham and Women’s Hospital. He also served as Clinical Faculty of Internal Medicine, Harvard Medical School, and Attending Physician in Internal Medicine, Brigham and Women’s Hospital. He received his Bachelor of Arts degree in biology from Harvard University and his Medical Degree from Yale University School of Medicine.
“We would like to thank Dr. Gary Ingenito for his incredible service to Catalyst over the past ten years and congratulate him on his formidable career in the biopharmaceutical industry,” continued Daly.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence while actively seeking to expand its global commercial footprint through strategic agreements. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America’s Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.
For more information, please visit Catalyst’s website at www.catalystpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst’s Annual Report on Form 10-K for the 2024 fiscal year, Catalyst’s Quarterly Report on Form 10-Q for the first quarter of 2025, and its subsequent filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Investor Contact
Mary Coleman, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
ir@catalystpharma.com
Media Contact
David Schull, Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com