CHRS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-11

• On February 4, 2026, we announced a clinical supply agreement with Janssen Research & Development, LLC, to evaluate tagmokitug in combination with pasritamig, a T-cell engaging bispecific antibody, in a Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer. Under t…

• Under the terms of the Collaboration Agreement, we paid $150.0 million upfront for exclusive rights to LOQTORZI in the United States and Canada. We obtained the right to conduct all commercial activities of LOQTORZI in the United States and Canada. We have paid $25.0 million for the achievement of c…

• The increase in LOQTORZI net revenue for the three months ended March 31, 2026 compared to the same period in the prior year was driven primarily by volume growth of LOQTORZI.

• We expect net revenue from continuing operations in 2026 to be higher than in 2025 because of continued growth of LOQTORZI.

• The increase in cost of goods sold from continuing operations for the three months ended March 31, 2026 compared to the same period in the prior year was primarily due to volume growth of LOQTORZI.

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

• Under the terms of the Collaboration Agreement, we paid $150.0 million upfront for exclusive rights to LOQTORZI in the United States and Canada, an option in these territories to Junshi Biosciences’ anti-TIGIT antibody CHS-006, an option in these territories to a next-generation engineered IL-2 cyto…

• The following represents a summary of notable business updates and events since the filing of our Quarterly Report on Form 10-Q for the Quarterly Period ended June 30, 2025, including certain items from our press releases and Current Reports on Form 8-K, which readers are encouraged to review in ful…

• As previously disclosed, on June 30, 2025, we received a deficiency notice from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying us that, for 30 consecutive business days, the bid price for our common stock had closed below $1.00 per share, the …

• On September 5, 2025, we received a letter from Nasdaq notifying us that the Staff had determined that the closing price of our common stock was $1.00 or greater for the requisite period of time, that we had regained compliance with Listing Rule 5550(a)(2) and that the matter was now closed.

• The UDENYCA Sale represented the last and most significant divestiture of the Company’s biosimilar businesses, which comprised the UDENYCA, YUSIMRY and CIMERLI franchises; therefore, the strategic shift criteria had been met and discontinued operations presentation has been included in the condensed…

Text added vs the prior filing · source: 10-Q · 2026-05-11

• We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and in Item 10(f)(1) of Regulation S-K, therefore this disclosure item is not applicable.

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

• We qualify as a “smaller reporting company”, as defined by Rule 12b-2 of the Exchange Act, and as a result we have elected to not provide the information required under this Item 3.

Text added vs the prior filing · source: 10-Q · 2026-05-11

• There has been no change in the Company's internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) that occurred during the first quarter ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial …

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

• Based on this evaluation, and as a result of the material weakness described below, our President and Chief Executive Officer and our Chief Financial Officer have concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were no…

• Material Weakness in Internal Control over Financial Reporting

• A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be detected or prevented on a timely basis.

• During the year ended December 31, 2024, we identified a material weakness in the operating effectiveness of our procedures related to documentation and review of certain inventory account reconciliations. The lack of sufficient evidence of the review performed over these accounting records did not …

• We have been taking steps to remediate this material weakness and to strengthen our internal control over financial reporting. The remediation measures include additional training and enhancement of our documentation and retention procedures, particularly as they relate to our inventory account reco…

Text added vs the prior filing · source: 10-Q · 2026-05-11

• approval. Innovative oncology product development is a highly speculative undertaking and involves a substantial degree of risk.

• For example, as of March 31, 2026, we had an accumulated deficit of $1.4 billion. The losses and accumulated deficit were primarily due to the substantial investments we made to commercialize our product and identify, develop or acquire our product candidates, including conducting, among other thing…

• The commercial success of our existing product or any future products will depend upon the size of the applicable markets and the degree of market acceptance and adoption by prescribing physicians, healthcare providers and the

• ●our ability to compete in our approved indication for nasopharyngeal carcinoma with chemotherapy regimens and with off-label immunotherapy agents in a competitive immuno-oncology market;

• disparity, our outreach may have little success or may never be successful. If our product or any future product candidates that are approved fail to achieve an adequate level of acceptance by physicians, patients, third-party payers and others in the medical community, we will not be able to genera…

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

• Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under…

• ●We have a limited history of profitability, which we have not maintained and may not achieve again, and only one product that has been approved and marketed and with multiple product candidates that are not approved and still in development.

• ●The commercial success of our existing product or any future products will depend upon the degree of market acceptance and adoption by prescribing physicians, healthcare providers and the patients to whom our medicines are prescribed. Additionally, obtaining placement on national and/or local clini…

• ●As we have in-licensed development and/or commercial rights to LOQTORZI, we rely on prior and ongoing preclinical, clinical, regulatory and manufacturing expertise of our collaborators in order to advance this product candidate through regulatory approvals in the United States and other licensed te…

• ●Our product and our product candidates, even if approved, will remain subject to regulatory scrutiny.

Text added vs the prior filing · source: 10-Q · 2026-05-11

• (c)During the three months ended March 31, 2026, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each such term is defined in Item 408(a) of Regulation S-K.

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

• On October 21, 2025, we sold to certain unaffiliated third-party investors (i) an aggregate of 4,634,995 shares of our common stock and (ii) Warrants to purchase an aggregate of 463,498 shares of common stock, each for an exercise price of $0.01 per share, for an aggregate purchase price of $8.0 mil…

• The Private Placement was conducted pursuant to an exemption from registration under the Securities Act under Section 4(a)(2) of the Securities Act. The Shares, Warrants and shares issuable upon exercise of the Warrants were not registered under the Securities Act or any state securities laws and ma…

• (c)During the three months ended September 30, 2025, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each such term is defined in Item 408(a) of Regulation S-K.