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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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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
LIGAND PHARMACEUTICALS INCORPORATED
(Exact Name of Registrant as Specified in Its Charter)
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| Delaware |
001-33093 |
77-0160744 |
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(Commission File Number) |
(I.R.S. Employer |
| incorporation or organization) |
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Identification No.) |
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| 555 Heritage Drive, Suite 200 |
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| Jupiter |
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| Florida |
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33458 |
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(Zip Code) |
(858) 550-7500
(Registrant’s Telephone Number, Including Area Code)
N/A
(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:
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Trading Symbol(s) |
Name of each exchange on which registered |
| Common Stock, par value $0.001 per share |
LGND |
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 ☐
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 1.01 Entry into a Material Definitive Agreement.
On February 24, 2025, Ligand Pharmaceuticals Incorporated (“Ligand”) entered into a Purchase and Sale Agreement (the “Agreement”) with Castle Creek Biosciences, Inc., Castle Creek Biosciences, LLC (collectively, “Castle Creek”) and a syndicate of co-investors for which Ligand acted as representative (collectively, including Ligand, the “Purchasers”), to support Castle Creek’s autologous human fibroblast cell-based gene therapy genetically modified to express COL7, also known as FCX-007 (dabocemagene autoficel) (“D-Fi”) Phase 3 clinical study, its lead candidate for patients with dystrophic epidermolysis bullosa (“DEB”).
Pursuant to the Agreement, Ligand and the other Purchasers obtained, for an aggregate purchase price of $75 million, $50 million of which was paid by Ligand and $25 million of which was paid by the other Purchasers collectively, (i) a high single digit royalty on worldwide sales of D-Fi and (ii) warrants (“Warrants”) to purchase shares of Castle Creek Biosciences, Inc. Series D-1 Preferred Stock (“Shares”). The Warrants are exercisable until February 24, 2035.
As part of the Agreement, Castle Creek granted the Purchasers a security interest in certain assets related to the programs included in the Agreement, subject to certain customary exceptions.
In connection with the transaction Ligand also acquired an unsecured subordinated promissory note issued by Castle Creek Biosciences, LLC with an aggregate principal amount of $8.3 million, which note is due and payable upon Castle Creek’s receipt of U.S. Food and Drug Administration approval of D-Fi for treatment of DEB and certain other conditions to payment. Ligand paid $1.8 million for the unsecured subordinated promissory note.
The above summary of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which will be filed, with confidential terms redacted, as an exhibit to Ligand’s Quarterly Report on Form 10-Q to be filed with respect to the quarter ended March 31, 2025.
Item 7.01 Regulation FD Disclosure.
On February 25, 2025, Ligand issued a press release announcing its entry into the Agreement. A copy of the press release is furnished herewith as Exhibit 99.1 to this report.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 of this report, including Exhibit 99.1, 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 liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
Description |
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Press release dated February 25, 2025. |
Forward-Looking Statements
This report contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, as amended, that involve a number of risks and uncertainties and reflect Ligand’s judgment as of the date of this report. Although our forward-looking statements reflect the good faith judgment of our management, these statements can only be based on facts and factors currently known by us. Consequently, these forward-looking statements are inherently subject to risks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the forward-looking statements.
All statements contained herein, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, forward-looking statements can be identified by the use of forward-looking words such as “believes,” “expects,” “may,” “will,” “plan,” “intends,” “estimates,” “would,” “continue,” “seeks,” “pro forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future matters such as those related to our future results of operations and financial position; Ligand’s future royalty payments due under the Agreement; product development and product regulatory filings and approvals, and the timing thereof, including the trial and regulatory success of Castle Creek’s upcoming Phase 3 trial of D-Fi for patients with DEB; the potential high patient impact, and revenue potential, of D-Fi; Ligand may not receive expected revenue under this Agreement or others; Ligand or its partners may not be able to protect their intellectual property, and patents covering certain products and technologies may be challenged or invalidated which could expose Ligand to significant liabilities and have a material adverse effect on the company; as well as other statements that are not historical in nature. You should be aware that failure to meet expectations with regard to any of the foregoing matters could negatively affect our results of operations, financial condition and the trading price of our stock.
The cautionary statements made in this report are intended to be applicable to all related forward-looking statements wherever they may appear in this report. We urge you not to place undue reliance on these forward-looking statements, which reflect our good-faith beliefs (or those of indicated third parties) and speak only as of the date of this report. Except as required by law, we disclaim any intent or obligation to update these forward-looking statements beyond the date of this report, even if new information becomes available in the future. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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LIGAND PHARMACEUTICALS INCORPORATED |
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| Date: February 25, 2025 |
By: /s/ Andrew Reardon
Name: Andrew Reardon
Title: Chief Legal Officer and Secretary
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EX-99.1
2
exhibit991_castlecreekdeal.htm
EX-99.1
Document
FOR IMMEDIATE RELEASE
Ligand Leads $75 Million Royalty Financing in Castle Creek Biosciences
Capital will fund Castle Creek’s D-Fi Phase 3 clinical trial for patients with dystrophic epidermolysis bullosa through topline data results
Ligand invested $50 million and a syndicate of co-investors invested $25 million in return for a high-single digit royalty on D-Fi
JUPITER, Fla., February 25, 2025 – Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced it has closed a royalty financing agreement with Castle Creek Biosciences, Inc. to support the Phase 3 clinical study of D-Fi (FCX-007), Castle Creek’s lead candidate, in patients with dystrophic epidermolysis bullosa (DEB).
Ligand originated, structured, and invested $50 million and led a syndicate of co-investors who invested $25 million in exchange for a high-single digit royalty on worldwide sales of D-Fi. The syndicate includes existing Castle Creek investors Paragon Biosciences and Valor Equity Partners and new investor XOMA Royalty Corporation (Nasdaq: XOMA).
“Partnering with Castle Creek is an exciting opportunity to advance an orphan drug-designated gene therapy for a serious unmet medical need through Phase 3 development,” said Todd Davis, CEO of Ligand. “This collaboration reflects our commitment to invest in groundbreaking de-risked treatments that can transform patients' lives and expand our diversified portfolio of revenue-generating assets.”
“We are pleased Ligand and our syndicate of investors recognized the potential of this critical therapy, which we believe represents a significant step forward in addressing the needs of patients living with DEB,” commented Matthew Gantz, president and CEO of Castle Creek. “Having a sophisticated investor like Ligand work closely with our extremely supportive equity partners made this transaction to support our Phase 3 clinical trial possible.”
D-Fi is an injectable autologous gene-modified cell therapy candidate for the treatment of DEB, a devastating, progressive, painful, and debilitating rare genetic skin disorder. DEB is caused by a mutation in the COL7A1 gene, leading to a deficiency of normal type VII collagen (COL7) protein, impairing the connection between the epidermis and the dermis. D-Fi is comprised of a patient’s own dermal fibroblasts, which are genetically modified completely ex vivo with a self-inactivating (SIN) lentiviral vector (LV) containing the COL7A1 gene to express COL7. D-Fi is locally administered by intradermal injection into chronic wounds where the COL7 protein can support the formation of anchoring fibrils in the skin.
In clinical studies, D-Fi has been generally well tolerated, with injection site reactions (skin discoloration, erythema, hemorrhage, pain, and swelling) being the primarily reported adverse drug reactions. D-Fi was granted Orphan Drug Designation for the treatment of DEB and granted Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy designations for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) by the FDA.
About Castle Creek Biosciences, Inc.
Castle Creek Biosciences is a late-stage company developing re-dosable gene therapies. It is conducting a pivotal clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa (DEB). Learn more at castlecreekbio.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s NITRICIL™ platform technology facilitates tunable dosing, permitting an adjustable drug release profile to allow proprietary formulations that target a broad range of indications. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Gilead Sciences, and Baxter International. For more information, please visit www.ligand.com. Follow Ligand on X @Ligand_LGND.
We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts.
Forward-Looking Statements
This news release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, statements regarding: Ligand’s future royalty payments due under its agreement with Castle Creek, the trial and regulatory success of Castle Creek’s upcoming Phase 3 trial of D-Fi for patients with dystrophic epidermolysis bullosa (DEB), the potential high patient impact, and revenue potential of D-Fi; Ligand may not receive expected revenue under its agreement with Castle Creek or others, Ligand or its partners may not be able to protect their intellectual property, and patents covering certain products and technologies may be challenged or invalidated which could expose Ligand to significant liabilities and have a material adverse effect on the company.
The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional license fees and milestone revenues we may receive. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts
For Ligand:
Investors:
Melanie Herman
investors@ligand.com
(858) 550-7761
Media:
Kellie Walsh
media@ligand.com
(914) 315-6072
For Castle Creek Biosciences:
Sheridan Chaney
(312) 847-1323
sc@paragonbiosci.com
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