CLYM — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• thrombocytopenia (ITP), and systemic lupus erythematosus (SLE), which we believe each offer a strong mechanistic rationale for CD19-directed therapy.

• In November 2025, we dosed the first patient in our Phase 2 clinical trial of budoprutug in pMN patients with persistent proteinuria despite optimized renin-angiotensin-aldosterone system (RAAS) inhibition, known as PrisMN. PrisMN, an open-label, dose-ranging Phase 2 clinical trial, is designed to f…

• In June 2025, we dosed the first patient in our open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP, which is designed to evaluate safety, tolerability, PK, PD, and preliminary efficacy, including B-cell depletion and platelet counts. Results from this trial are…

• In June 2026, we presented initial Phase 1b data in patients with primary ITP at the European Hematology Association, which demonstrated an encouraging safety and tolerability profile, robust B-cell depletion, and meaningful platelet responses in heavily pretreated patients. Initial safety and effic…

• Target enrollment for the Phase 1b/2a trial is approximately 24 patients, which is expected to be achieved within the Phase 1b portion of the study. We expect the Phase 1b dataset will provide adequate information to inform dose selection and future development planning in ITP and other immune-media…

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

• In March 2025, we received clearance from the FDA for a Phase 2, dose range finding clinical trial of budoprutug in pMN, known as PrisMN. We have initiated our Phase 2 clinical trial of budoprutug in pMN patients with persistent proteinuria despite optimized renin-angiotensin-aldosterone system (RAA…

• Separately, in March 2025, we received clearance from the FDA for an open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP to evaluate safety, tolerability, PK, PD, and preliminary efficacy, including B cell depletion and platelet counts. We have also received reg…

• In October 2024, we received FDA clearance for a Phase 1b clinical trial of budoprutug in moderate to severe SLE. We are actively enrolling patients in this global, open-label, dose-escalation Phase 1b trial. In this trial, a single dose of budoprutug will be administered in moderate to severe SLE p…

• In December 2025, we received clearance of our IND to initiate a separate, parallel Phase 1b/2a clinical trial in SLE patients in China, which will complement our ongoing global Phase 1b clinical trial and also seek to enroll SLE patients who have lupus nephritis (LN). We expect to enroll the first …

• The above described clinical trials of budoprutug in pMN, ITP and SLE utilize an intravenous (IV) formulation of budoprutug. In parallel, we are advancing a high-concentration subcutaneous (SC) formulation of budoprutug, which may offer a differentiated convenience profile and potential commercial a…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Advertising and promotion of any product candidate that obtains approval in the U.S. will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS), state attorneys general, members of Congress and the publ…

• If we successfully obtain approval for budoprutug or CLYM116, we believe that the key competitive factors that will affect the success of these candidates will be efficacy, safety, tolerability, convenience, price and the availability of reimbursement from

• government and other third-party payors relative to such competing products. Our commercial opportunity could be reduced or eliminated if our competitors have products that are superior in one or more of these categories.

• For example, the recent loss and retirement of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review and approval of our product candidates. The current administration has substantially reduced the FDA’s workforce and may make further reductions, which may lead to…

• Further, drug manufacturers may be subject to an excise tax for failing to participate in price negotiations or charging more than the negotiated “maximum fair price” and civil money penalties for not complying with the terms of the program. In addition to the drug price negotiation program, the IRA…

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

• For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of effectiveness for the proposed product for its intended use(s). The FDA has interpreted this evidentiary standard to generally require two adequate and well-controlled clinical tr…

• other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.

• Advertising and promotion of any product candidate that obtains approval in the U.S. will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS), state attorneys general, members of Congress and the publ…

• Our ability to develop and market new product candidates may also be impacted by litigation challenging the FDA’s approval of another company’s drug product. In April 2023, the U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product …

• in healthy volunteers, and our Phase 1 clinical trial of CLYM116. In addition, the commencement and rate of completion of nonclinical studies and clinical trials may be delayed by many factors, including:

Text added vs the prior filing · source: 10-Q · 2026-08-06

• The adoption or termination of contracts, instructions or written plans for the purchase or sale of our securities by our Section 16 officers and directors for the three months ended June 30, 2026, which is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange A…

• Maximum Number of Securities to be Purchased or Sold Pursuant to the Rule 10b5-1 Trading Plan

• Until September 15, 2027, or, if earlier, upon the completed sale of the maximum shares

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

• None of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a Rule 10b5-1 trading arrangement for the sale of our common stock that is intended to satisfy the affirmative defense conditions of the Exchange Act Rule 10b5-1(c) (Rule 10b5-1 Trading Plan)…