ATRA — what changed in the latest 10-Q

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

• and in a qualified manufacturing facility also include direct and indirect costs related to the production of Ebvallo. Such costs are recorded into cost of commercialization revenue as the related commercialization revenue is recognized. Such costs include, but are not limited to, CMO costs, quality…

• Research and development expenses consist primarily of compensation and benefits for research and development and regulatory support employees, including stock-based compensation; expenses incurred under agreements with contract research organizations and investigative sites that conduct preclinical…

• Medical and safety expenses were $0.1 million and ($1.2) million in the three and six months ended June 30, 2026, as compared to $3.6 million and $9.0 million in the comparative 2025 periods. The decrease in 2026 was primarily due to reduced headcount following the 2025 reductions in force, transiti…

• Interest expense was $0.2 million and $1.0 million in the three and six months ended June 30, 2026, as compared to $1.0 million and $2.0 million in the comparative 2025 periods, primarily due to lower non-cash interest expense recognized on the liability related to the sale of future revenues under …

• During the six months ended June 30, 2026, we sold an aggregate of 991,017 shares of common stock under the 2023 ATM Facility, at an average price of $7.97 per share, for gross proceeds of $7.9 million and net proceeds of $7.7 million, after deducting commissions and other offering expenses payable …

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• In April 2026, Pierre Fabre, with our support, had a productive meeting with the FDA and discussed with the FDA a potential path forward to resubmitting the tab-cel BLA. The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a …

• The largest component of our total operating expenses since inception has been our investment in research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits for res…

• In the three months ended March 31, 2026 medical and safety expenses were approximately ($1.3) million, which reflects a change in estimate of final clinical related costs upon agreement being reached in this period. In the three months ended March 31, 2025 medical and safety expenses totaled $5.3 m…

• Interest expense was $0.8 million in three months ended March 31, 2026, as compared to $1.0 million in the comparative 2025 period, primarily due to lower finance lease interest expense.

• of 1933, as amended (Securities Act), and were registered under the Securities Act. Commissions of up to 3.0% are due on the gross sales proceeds of the common stock sold under each ATM facility.

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

• regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to review and process our regulatory submissions in a timely fashion, which could have a material adverse effect on our business.

• In December 2025, the EU legislators reached a political agreement to adopt two new pieces of legislation, which will amend and/or repeal and replace the existing legislation concerning medicinal products for human use in the EU, including legislation concerning orphan medicinal products and medicin…

• We have in the past and may in the future fail to meet the continued listing standards of the Nasdaq Stock Market LLC (Nasdaq), and as a result, our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.

• Our common stock is currently listed on the Nasdaq Global Select Market, and we are therefore subject to its continued listing requirements, including, among others, the requirement to maintain a minimum market value of $50 million for listed securities (the MVLS Requirement). If we fail to satisfy …

• On April 30, 2026, we received a notice from the Listing Qualifications department of Nasdaq (the Staff) notifying us that we were not then in compliance with the MVLS Requirement for continued listing on the Nasdaq Global Select Market, based on the Staff's review of the market value of our common …

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• In April 2023, the EC published proposals to revise the existing European legislation on medicinal products (EU Pharma Law Review). The revisions consist of two proposals, a new directive and a new regulation (EU Pharma Law Proposal) that would amend and/or repeal and replace the relevant legislatio…

• We have been notified by The Nasdaq Stock Market LLC (Nasdaq) of our failure to comply with one of its continued listing standards. If we continue to fail to meet the listing standards of Nasdaq, our common stock may be delisted, which could have a material adverse effect on the liquidity of our com…

• Our common stock is currently listed on the Nasdaq Global Select Market. Nasdaq has requirements that a company must meet in order to remain listed on Nasdaq. In particular, Nasdaq rules require us to maintain a minimum market value of $50 million for listed securities (the MVLS Requirement). If the…

• In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we have been provided a period of 180 calendar days, or until October 27, 2026 (the Compliance Date), to regain compliance with the MVLS Requirement. If, at any time before the Compliance Date, our MVLS closes at $50 million or more for a minimum…

• We intend to actively monitor the market value of our listed securities. We may evaluate and consider available options for regaining compliance with the MVLS Requirement, which could include applying for a transfer to The Nasdaq Capital Market. However, there can be no assurance that we will take a…