3 unchanged sentences
Therefore, no assurance can be given on the outcome of any proceeding or the potential impact on our results of operations or financial condition.
+Added: Settlement and General Release:
During the period ended December 31, 2022, Altor/NantCell initiated legal proceedings against Dr.
8 unchanged sentences
The Arbitration hearing was held from May 20, 2024 to May 31, 2024, after which the parties entered into settlement negotiations.
−Removed: As reported in the Company’s Form 8-K filed on July 18, 2024, as of July 13, 2024, the Company and Dr.
+Added: As reported in the Company’s Form 8-K filed on July 18, 2024 and further described in Part I, Item 3.
+Added: – “Legal Proceedings” below, as of July 13, 2024, the Company and Dr.
Wong, the Company’s Founder and Chief Executive Officer, entered into a confidential Settlement Agreement and Release (the “Settlement Agreement”) with Altor BioScience, LLC (“Altor”), NantCell, Inc.
4 unchanged sentences
No party is required to make any monetary payments to any other party or person under the Settlement Agreement and each party will bear its own expenses incurred in connection with the matter.
−Removed: The Company has completed the required remediation procedures.
−Removed: As of the filing date, the parties to the Settlement Agreement are working together to finalize the notices and related final documentation to obtain dismissal of the Arbitration and Complaint.
−Removed: In accordance with 17 CFR 229.601 (Item 601), the Company has included the Settlement Agreement in the Quarterly Report on this Form 10-Q.
−Removed: Pursuant to the Settlement Agreement, the Company transferred and assigned to ImmunityBio ownership of certain intellectual property (including issued patents, pending patent applications, and know-how) for TOBI TM -based molecules for use in the oncology field.
−Removed: The Company retains the worldwide, perpetual, irrevocable, fully paid-up, royalty-free, exclusive right and license to exploit HCW9218 for all age-related diseases other than cancer, with the exception of the treatment of ovarian cancer, which is also retained by the Company and is currently being studied in a Phase 2 clinical trial at the University of Pittsburgh Medical Center.
+Added: In accordance with the provisions of the Settlement Agreement, upon completion of remedial procedures, the parties stipulated that the Arbitration and Complaint should be dismissed.
+Added: The Arbitration and related Complaint were dismissed with prejudice on or about December 24, 2024.
+Added: Pursuant to the Settlement Agreement, the Company transferred and assigned to ImmunityBio ownership of certain intellectual property (including issued patents, pending patent applications, and know-how) for TOBI-based molecules.
+Added: The Company retains the worldwide, perpetual, irrevocable, fully paid-up, royalty-free, exclusive right and license to exploit HCW9218 for all age-related diseases other than cancer.
The Company also retains the right to develop treatments for all indications with respect to HCW9302 and HCW9206, which, along with HCW9218, are the lead product candidates in the Company’s clinical development pipeline.
−Removed: ImmunityBio has the exclusive right to pursue oncology indications with all of the TOBI TM -based molecules designed with a TGF-β domain, including HCW9218, with the exception of the treatment of ovarian cancer with HCW9218 in combination with neoadjuvant chemotherapy, which is retained by the Company.
−Removed: Under the Settlement Agreement, ImmunityBio also receives an exclusive license to exploit fusion proteins, molecules and/or antibodies created utilizing the TOBI TM Platform directed to the receptors of PDL-1, IL-7, IL-12, IL-18, and IL-21, and one additional target to be selected by ImmunityBio within six months from the date of the Settlement Agreement, at its sole discretion, in the oncology field.
+Added: ImmunityBio has the exclusive right to pursue oncology indications with all of the TOBI-based molecules designed with a TGF-β domain, including HCW9218.
+Added: Under the Settlement Agreement ImmunityBio also receives an exclusive license to exploit fusion proteins, molecules and/or antibodies created utilizing the TOBI platform directed to the receptors of PDL-1, IL-7, IL-12, IL-18, IL-15, and IL-21 in the oncology field.
The Company’s ownership and rights with respect to HCW9302, HCW9206 and HCW9201 are expressly excluded from the rights transferred to ImmunityBio for oncology indications.
In addition, ImmunityBio received a non-exclusive license to exploit HCW9201 administered by injection for oncology indications.
−Removed: The Company retains ownership and control of the TOBI TM platform and TOBI-based molecules, with no restrictions under the Settlement Agreement on our ability to use the TOBI TM platform for protein-fusion molecules for non-oncology indications.
+Added: The Company retains ownership and control of the TOBI platform and TOBI-based molecules, with no restrictions under the Settlement Agreement on our ability to use the TOBI platform for protein-fusion molecules for non-oncology indications.
We have rights to pursue oncology indications, in particular using HCW9302, HCW9206 and HCW9201.
Further, the Company retains ownership of the Wugen license and shares of Wugen common stock transferred to the Company as the upfront licensing fee from Wugen for granting the Wugen license.
−Removed: For our lead molecule, HCW9218, we maintain the non-exclusive right to use HCW9218 in combination with neoadjuvant chemotherapy in ovarian cancer, in addition to exclusive rights for clinical development and use of HCW9218 in the treatment of all non-oncological diseases.
+Added: For our molecule, HCW9218, we maintain the exclusive rights for clinical development and use of HCW9218 in the treatment of all non-oncological diseases.
We retain ownership of our lead molecule, HCW9302, which expands T reg cells and is designed to treat autoimmune diseases and other proinflammatory diseases, including cancer, and the ownership of HCW9206, a preclinical molecule which we are developing for the treatment of cancer and other age-related diseases.
1 unchanged sentence
We have no restrictions on the development of HCW9206 for our own clinical development activities, including oncology indications.
−Removed: Under the terms of the Settlement Agreement, ImmunityBio will own the cell line and supply for HCW9218, and the
−Removed: parties agreed that within six months from the date of the Settlement Agreement they will enter into a supply agreement providing the Company with a continuing supply of HCW9218 molecules.
+Added: Under the terms of the Settlement Agreement, ImmunityBio will own the cell line and supply for HCW9218, and the parties agreed that within six months from the date of the Settlement Agreement they will enter into a supply agreement providing the Company with a continuing supply of HCW9218 molecules.
+Added: However, as of the reported date, the supply agreement of HCW9218 is not yet in place.
The Company also retains in vivo rights to HCW9201, a combination of IL-12, IL-15, and IL-18 in a single protein complex which is designed to stimulate activation and proliferation signals in human NK cells.
The Company retains ownership of the cell lines for HCW9302, HCW9206 and HCW9201, and thus will retain independent control over manufacturing and supply for these compounds.
+Added: Other Matters
+Added: As the Company reported in a Form 8-K, on April 17, 2025, the Company received a summons and a copy of a complaint filed by BE&K in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “BE&K Complaint”).
+Added: Other Defendants named in the BE&K Complaint who are subcontractors elected to filed counterclaims and cross-claims in response thereto.
+Added: Cogent Bank, also named as a Defendant in the BE&K Complaint, has not elected to take legal action at this time.
+Added: In addition, on April 28, 2025, the Company received a summons and a copy of a complaint filed by Fisk Electric Company (which is a defendant in the BE&K Litigation) in the Circuit Court of the 17th Judicial Circuit in and for Broward County, Florida (the “Fisk Complaint”) against the Company, BE&K, and the other defendants in the BE&K Complaint.
+Added: The Company intends to respond in a timely fashion to the BE&K and Fisk Complaints and cross-claims.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.