CLYM — what changed in the latest 10-Q

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

• Our lead product candidate, budoprutug, is a clinical-stage anti-CD19 monoclonal antibody (mAb) designed to deplete CD19-positive B cells. CD19 plays a mechanistic role across all stages of B-cell development, and emerging clinical evidence continues to support the importance of CD19 in immune-media…

• 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 …

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Our lead product candidate, budoprutug, is a clinical-stage anti-CD19 monoclonal antibody (mAb) which has the potential to address a broad range of B-cell mediated diseases. Budoprutug is designed to deplete CD19-positive B cells, including antibody secreting cells (plasma blasts), in order to direc…

• We are initially developing budoprutug in lead indications representing each of these three opportunity sets, namely primary membranous nephropathy (pMN), a primarily IgG4-mediated disease, immune thrombocytopenia (ITP), a primarily single organ IgG1-3 mediated disease, and systemic lupus erythemato…

• In March 2025, we received clearance from the FDA for a Phase 2, dose range finding clinical trial of budoprutug in pMN. Budoprutug was previously evaluated in a Phase 1b clinical trial in pMN, the results of which suggest that budoprutug may offer the opportunity to induce remission of pMN in patie…

• Separately, in March 2025, we received clearance from the FDA for our IND application to initiate an open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B c…

• In October 2024, we received clearance from the FDA for our IND application to initiate an open-label, dose-escalation Phase 1b clinical trial of budoprutug in patients with SLE to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B-cell depletion…

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

• Information with respect to legal proceedings is described in Note 6 "Commitments and Contingencies" in the Notes to the Unaudited Condensed Consolidated Financial Statements contained in Part I, Item I of this Quarterly Report, which is incorporated herein by reference.

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• From time to time, in the ordinary course of business, we may be involved in various claims, lawsuits and other proceedings. As of the date of filing of this Quarterly Report, we were not involved in any material legal proceedings.

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

• To date, we have not received regulatory approvals for any of our product candidates or generated any revenue from product sales. We do not expect to generate revenue from product sales for the foreseeable future. Budoprutug and CLYM116 are both in early stages of research and development. As a resu…

• If we are unable to access capital when needed, it could force us to delay, reduce or terminate our product candidate development programs, commercialization efforts, or other operations.

• Conducting nonclinical studies and clinical trials, obtaining regulatory approvals, and preparing for potential commercialization are costly, time-consuming, and subject to significant uncertainty. Cash, cash equivalents, and marketable securities were $146.3 million as of March 31, 2026. Based on i…

• the number and scope of development, nonclinical and clinical programs we decide to pursue, and the timing, cost and progress of activities related to such programs;

• the costs of manufacturing our product candidates by third parties;

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• To date, we have not received regulatory approvals for any of our product candidates or generated any revenue from the sale of products, and we do not expect to generate any revenue for the foreseeable future. Budoprutug and CLYM116 are both in early stages of research and development. As a result, …

• initiate and continue research and development, including preclinical and clinical efforts for our product candidates;

• conduct ongoing and future clinical trials of our product candidates;

• seek regulatory approvals for our product candidates that successfully complete clinical development;

• incur legal, accounting, or other expenses in operating our business;