TRAX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-12

• The FDA granted Fast Track designation to ANB033 for the treatment of people with CeD on a gluten-free diet.

• our financial statements included elsewhere in this Quarterly Report for additional information regarding new or revised accounting pronouncements.

• Research and development expenses were $59.6 million during the six months ended June 30, 2026 compared to $80.7 million during the six months ended June 30, 2025, a decrease of $21.1 million. The decrease is primarily attributable to a $20.1 million decrease in clinical and related expenses, and a …

• General and administrative expenses were $28.1 million during the six months ended June 30, 2026 compared to $16.4 million during the six months ended June 30, 2025, an increase of approximately $11.7 million. The increase is primarily due to a $2.6 million increase in personnel costs, an increase o…

• Interest income was $3.9 million and $7.6 million during the six months ended June 30, 2026 and 2025, respectively, which primarily related to our short-term and long-term investments. The decrease in interest income is primarily due to the decrease in investment balances, as well as the timing of s…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Refer to Note 2 to our combined financial statements included elsewhere in this Quarterly Report for additional information regarding new or revised accounting pronouncements.

• Other expense, net was less than $0.1 million during the three months ended March 31, 2026 and 2025, respectively.

• As of March 31, 2026, and prior to the Spin-Off, we had $286.5 million in cash and cash equivalents.

• The net cash provided by financing activities during the three months ended March 31, 2026 and 2025 of $7.9 million and $5.7 million, respectively, was due to the net investment by AnaptysBio.

Text added vs the prior filing · source: 10-Q · 2026-08-12

• Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and for…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and for…

• March 31, 2026, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Based…

Text added vs the prior filing · source: 10-Q · 2026-08-12

• for clinical trials, our ability to obtain marketing approval, or our ability to provide supply of our products for patients, if approved, could be delayed or stopped.

• narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

• Even if we or any future collaborators initiate and complete clinical trials for our product candidates, these product candidates will not be permitted to be marketed in the United States until approval of a Biologics License Application (“BLA”) from the FDA is

• received, and will not be permitted to be marketed in other countries without marketing approval from foreign regulatory authorities. Obtaining approval of a BLA or other marketing approvals is often a lengthy, expensive and uncertain process over which the FDA and foreign regulatory authorities hav…

• Our operations to date have been largely limited to financing and staffing our company, and developing our wholly owned product candidates. We have only very limited experience conducting pivotal Phase 3 clinical trials and have not had previous experience commercializing product candidates, includi…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Even if we or any future collaborators initiate and complete clinical trials for our product candidates, these product candidates will not be permitted to be marketed in the United States until approval of a Biologics License Application (“BLA”) from the FDA is received, and will not be permitted to…

• are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and standards. If we, any future collaborators or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated…

• Our operations to date have been largely limited to financing and staffing our company, and developing our wholly owned product candidates. We have only very limited experience conducting pivotal Phase 3 clinical trials and have not had previous experience commercializing product candidates, includi…

• The biotechnology industry is highly competitive and subject to rapid and significant technological change. Products we may develop in the future are also likely to face competition from other drugs and therapies, some of which we may not currently be aware of. We have competitors both in the United…

• For our anti-CD122 antagonist antibody program, our clinical competitors include an anti-CD122 antagonist antibody, FB-102 (Forte Bioscience) in Phase 2a development for the treatment of CeD, Phase 1b development for the treatment of vitiligo, and Phase 1b development for the treatment of alopecia a…