PCSA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• We are a clinical-stage biotechnology company. In July 2026, we acquired Vidya Therapeutics, Inc. (“Vidya”), a clinical-stage biotechnology company developing VT-7208, a Bruton’s tyrosine kinase (“BTK”) inhibitor therapy for immune-mediated diseases with an initial focus on food allergy, chronic spo…

• On July 28, 2026, we acquired Vidya, which brought Vidya’s lead asset VT-7208 into our pipeline. In connection with our acquisition of Vidya, we received $200 million in gross proceeds from a private placement financing of shares of our non-voting convertible preferred stock. We intend to use the ne…

• On July 23, 2026, we entered into a settlement agreement with Elion Oncology, Inc. (“Elion”) to resolve all claims arising from the parties’ litigation concerning the license agreement dated August 23, 2020, relating to the commercialization of PCS6422 (the “Elion License Agreement”). Under the sett…

• In connection with the settlement, we paid Elion $650,000 toward its attorneys’ fees and other out-of-pocket costs. We also agreed to grant Elion a non-voting equity interest equal to 7.5% of the fully diluted pre-money equity capitalization of any newly formed entity whose assets include one or mor…

• As a result of the settlement and the return of the PCS6422 program to Elion, we are closing our ongoing Phase 2 clinical trial of PCS6422 in advanced or metastatic breast cancer. On August 7, 2026, the stipulation of dismissal became effective, resulting in the dismissal of the litigation with prej…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We are a publicly listed clinical-stage biopharmaceutical company. We are developing a pipeline of Next Generation Cancer therapy (“NGC”) small molecules, one of which is currently in a Phase 2 trial, while the other is in pre-clinical development. Our risk-mitigated strategy is to identify existing…

• Our oncology pipeline currently consists of NGC-Cap and NGC-Iri (also identified as PCS6422 and PCS11T, respectively) and two non-oncology drugs (PCS12852 and PCS499). We are exploring options for our non-oncology drugs, which may include out-licensing or partnership opportunities. The current statu…

• In 2025, we continued our Phase 2 trial of NGC-Cap in advanced or metastatic breast cancer patients. We have enrolled and dosed the 20 patients required for the planned first interim analysis, which is expected to be completed in the first half of 2026.

• On February 17, 2026 where we sold 86,956 shares of our common stock to an accredited investor in a private placement transaction for $200,000. On March 31, 2026, certain directors, officers, and employees purchased 17,796 shares of common stock for approximately $45,000. They also purchased 22,008 …

• Comparison of the three months ended March 31, 2026 and 2025

Text added vs the prior filing · source: 10-Q · 2026-08-14

• Subsequent to the quarter ended June 30, 2026, we completed the Vidya Acquisition. In connection with the Vidya Acquisition, we have begun the process of integrating Vidya’s financial processes, systems, and personnel into our system of internal control over financial reporting. We expect this integ…

Text added vs the prior filing · source: 10-Q · 2026-08-14

• On July 23, 2026, we entered into a settlement agreement with Elion Oncology, Inc. (“Elion”) to resolve all claims arising from the parties’ litigation concerning the license agreement dated August 23, 2020, relating to the commercialization of PCS6422 (the “Elion License Agreement”). Under the sett…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• On May 7, 2024, the Company received notification from Elion purporting to terminate the license agreement by and between the Company and Elion as a result of the Company’s alleged breach thereof. The Company believes that Elion’s claims are without merit and disputes that the license agreement has …

Text added vs the prior filing · source: 10-Q · 2026-08-14

• Our business is highly dependent on the success of VT-7208. VT-7208 will require additional clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially and we may not be successful in our efforts.

• We currently have no products that are approved for commercial sale and may never be able to develop marketable products. Following the Vidya Acquisition, we are focusing the majority of our resources on the development of VT-7208 in food allergy, CSU and RMS and continuing the development of our le…

• We cannot provide you with any assurance that we will be able to successfully advance VT-7208 or any additional product candidates through the development process in any particular target indication. Our research programs may initially show promise in identifying potential product candidates, yet fa…

• ●our product candidates may not succeed in preclinical or clinical testing;

• ●a product candidate may on further study be shown to have harmful side effects, or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;