Precision BioSciences Terminates Novartis Gene Therapy Deal

TL;DR

Precision BioSciences just dumped Novartis on their gene therapy deal, keeping all their tech.

AI Summary

On April 11, 2024, Precision BioSciences, Inc. announced the termination of its collaboration and license agreement with Novartis Gene Therapies, Inc. This termination is effective immediately and relates to the development of gene therapies for sickle cell disease and beta-thalassemia. Precision BioSciences will retain all rights to its ARCUS genome editing platform and related technologies.

Why It Matters

The termination of this significant agreement could impact Precision BioSciences' future revenue streams and strategic direction, while Novartis Gene Therapies will need to find alternative solutions for its gene therapy pipeline.

Risk Assessment

Risk Level: medium — The termination of a material definitive agreement, especially one involving a major partner like Novartis, introduces uncertainty regarding future revenue and development progress.

Key Players & Entities

• Precision BioSciences, Inc. (company) — Registrant
• Novartis Gene Therapies, Inc. (company) — Partner in terminated agreement
• April 11, 2024 (date) — Date of earliest event reported
• sickle cell disease (condition) — Therapeutic area of terminated agreement
• beta-thalassemia (condition) — Therapeutic area of terminated agreement
• ARCUS genome editing platform (technology) — Technology retained by Precision BioSciences

FAQ

Key Financial Figures

• $0.000005 — ch registered Common Stock, par value $0.000005 per share DTIL The Nasdaq Capital M
• $135 million — d November 19, 2020, Precision received $135 million in upfront investment consisting of $10
• $100 million — ion in upfront investment consisting of $100 million upfront and $35 million from Lilly's pu
• $35 million — consisting of $100 million upfront and $35 million from Lilly's purchase of 125,406 shares
• $390 million — stone payments of up to an aggregate of $390 million to $395 million per licensed product as
• $395 million — f up to an aggregate of $390 million to $395 million per licensed product as well as nominat
• $137 million — cts to report that it had approximately $137 million in cash and cash equivalents as of Marc

Filing Documents

• dtil-20240411.htm (8-K) — 56KB
• dtil-ex99_1.htm (EX-99.1) — 32KB
• img259060178_0.jpg (GRAPHIC) — 12KB
• 0000950170-24-044831.txt ( ) — 235KB
• dtil-20240411.xsd (EX-101.SCH) — 27KB
• dtil-20240411_htm.xml (XML) — 5KB

02 Termination of a Material Definitive Agreement

Item 1.02 Termination of a Material Definitive Agreement. On April 11, 2024, Precision BioSciences, Inc. (the "Company") received written notice from Prevail Therapeutics Inc. ("Prevail"), a wholly-owned subsidiary of Eli Lilly and Company, of Prevail's termination of the Amended and Restated Development and License Agreement, dated June 30, 2023, between Prevail and the Company (the "Agreement"). Prevail's notice informed the Company that Prevail was exercising its right pursuant to Section 15.3.2 of the Agreement to terminate the Agreement in its entirety without cause upon 90 days' prior written notice to the Company. The termination will be effective on July 10, 2024. Pursuant to the terms of the Agreement, Precision and Prevail agreed to collaborate and develop the Company's ARCUS nucleases for the research and development of potential in vivo therapies for three initial genetic disorder targets, including Duchenne muscular dystrophy ("DMD") in muscle, a liver directed target ("PBGENE-LLY2") and a central nervous system directed target ("PBGENE-LLY3" and together with DMD and PBGENE-LLY2, the "Programs"). Under the original agreement with Eli Lilly and Company signed November 19, 2020, Precision received $135 million in upfront investment consisting of $100 million upfront and $35 million from Lilly's purchase of 125,406 shares of the Company's common stock (on a post-reverse stock split basis). The Agreement was amended and restated in June 2023 with Prevail assuming and funding preclinical research and investigational new drug application-enabling activities, which had previously been conducted by the Company at its expense, as well as assuming responsibility for the manufacturing of initial clinical trial material for the first licensed product. Upon the achievement of various milestones, the Company would have been entitled to receive milestone payments of up to an aggregate of $390 million to $395 million per licensed product as well as nomination fees

02 Results of Operations and Financial Condition

Item 2.02 Results of Operations and Financial Condition. Although it has not finalized its full financial results for the quarter ended March 31, 2024, the Company expects to report that it had approximately $137 million in cash and cash equivalents as of March 31, 2024. This estimate is unaudited and preliminary and does not present all information necessary for an understanding of the Company's financial condition as of March 31, 2024, and its results of operations for the quarter ended March 31, 2024. The review of the Company's financial statements for the quarter ended March 31, 2024 by the Company's independent registered public accounting firm is ongoing and could result in changes to the information set forth above.

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On April 16, 2024, the Company issued a press release announcing the termination of the Agreement. A copy of the press release, which is attached to this Current Report on Form 8-K as Exhibit 99.1, is furnished pursuant to this Item 7.01. The information under this Item 7.01 (including Exhibit 99.1 hereto) and Item 2.02 of this Current Report on Form 8-K is not deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. Registration statements or other documents filed with the SEC shall not incorporate this information by reference, except as otherwise expressly stated in such filing.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company's plans in connection with the termination of the Agreement, the Company's intention to exercise the Reversion Option, the future development of the Programs, including the possibility of new partners or collaborations for the Programs and the ability to generate future revenue from the Programs. In some cases, you can identify forward-looking statements by terms such as "aim," "anticipate," "approach," "believe," "designed to", "contemplate," "could," "estimate," "expect," "goal," "intend," "look," "may," "mission," "plan," "possible," "potential," "predict," "project," "pursue," "should," "target," "will," "would," or the negative thereof and similar words and expressions. Forward-looking statements are based on management's current expectations, beliefs and assumptions and on information currently available to us. Such statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, without limitation, our ability to procure sufficient funding or other partnership opportunities to advance the Programs or other programs on terms that are acceptable to us, or at all, the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our or o

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release of Precision BioSciences, Inc. dated April 16, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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. PRECISION BIOSCIENCES, INC. Date: April 16, 2024 By: /s/ John Alexander Kelly John Alexander Kelly Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR