Every 8-K that Connect Biopharma Holdings Limited (CNTB) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CNTB and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CNTB filings page.
Connect Biopharma Holdings Limited (CNTB) reported preliminary topline results from its global Phase 2 study of rademikibart, an add-on to standard care for acute COPD exacerbations in adults with type 2 inflammation. The randomized, placebo-controlled study enrolled 159 participants.
Through Week 4, the company reported an 81% reduction in treatment failure (p=0.0122), an 85% reduction in new moderate-to-severe exacerbations (p=0.030), and a 100% reduction in new emergency-department visits and hospital admissions for exacerbations (p=0.0137), versus placebo. A 70 mL greater FEV1 improvement versus placebo was reported at Week 4 (p=0.1607); the presentation states the key secondary Day 7 FEV1 endpoint was not significant. The company reported lower incidences of adverse and serious adverse events in the rademikibart arm and no new safety signals. The presentation also lists one death of unknown cause in that arm on Day 37, described as not related to COPD. Connect plans to engage with the FDA regarding a Phase 3 program.
Connect Biopharma Holdings Ltd (CNTB) reported preliminary topline data from its global Phase 2 Seabreeze STAT asthma trial of rademikibart as an add‑on treatment for acute exacerbations in adults and adolescents with asthma and type 2 inflammation. The randomized, double‑blind, placebo‑controlled study enrolled 160 participants, dosed once subcutaneously with 600 mg rademikibart or placebo in addition to standard of care.
Rademikibart reduced the composite treatment failure rate over 28 days by about 66% versus placebo, but the primary endpoint did not reach statistical significance (p=0.153) because overall event rates were much lower than projected. The key secondary endpoint showed a statistically significant improvement in lung function: mean post‑bronchodilator FEV1 increased 250 mL with rademikibart versus 120 mL with placebo at Day 7 (130 mL difference; p=0.023), with significance also at Day 28. Rademikibart was described as well tolerated, with low adverse‑event incidence and 1 serious adverse event versus 3 on placebo.
Connect Biopharma plans to report topline data from a Phase 2 COPD exacerbation study of rademikibart later in the month and then seek FDA alignment on a Phase 3 program. The company also highlights a large addressable market with low biologic use in asthma and notes up to $99 million in remaining potential milestones plus tiered royalties from its Greater China license partner.
Connect Biopharma Holdings Limited reported second-quarter 2026 results and clinical progress for rademikibart in asthma and COPD. Enrollment was completed in the Phase 2 Seabreeze STAT asthma and COPD studies, with topline data expected in September 2026, and a new Phase 2 Seabreeze STAT IV study was initiated in August 2026.
For the quarter ended June 30, 2026, license and collaboration revenues were $2.8 million, largely from a regulatory milestone under the Simcere license, versus $48,000 a year earlier. Research and development expense rose to $16.3 million, and general and administrative expense was $4.1 million. Net loss was $17.3 million, or ($0.27) per share, compared with $12.9 million, or ($0.23) per share, in 2025.
As of June 30, 2026, cash, cash equivalents and short-term investments totaled $31.5 million, and the company believes this will fund operations for at least one year from the release date. Under its Simcere agreement, Connect remains eligible for up to approximately $99 million in additional milestone payments plus tiered royalties on Greater China net sales.
Connect Biopharma Holdings Limited reported first quarter 2026 results and highlighted progress on its asthma and COPD programs. For the three months ended March 31, 2026, license and collaboration revenues were $169,000, compared with none a year earlier. Research and development expense rose to $15.0 million, mainly from Phase 2 Seabreeze STAT asthma and COPD studies, while general and administrative expense was $4.7 million.
Net loss increased to $19.4 million, or ($0.34) per share, versus $10.3 million, or ($0.19), in 2025. Cash, cash equivalents and short-term investments totaled $46.0 million as of March 31, 2026, supported by a $20.2 million private placement that closed on March 31, 2026, which provided estimated net proceeds of $18.6 million. Management believes this cash should fund operations into the second half of 2027.
The company is advancing rademikibart, an antibody targeting IL‑4Rα, with Phase 2 Seabreeze STAT studies in acute exacerbations of asthma and COPD continuing as planned after an independent data monitoring committee review. Topline data from both Phase 2 studies are expected mid‑2026, and positive Phase 1 intravenous rademikibart data showed rapid and durable lung function improvements. In China, partner Simcere reported Phase 3 atopic dermatitis results with rapid, durable efficacy through 52 weeks. Connect remains eligible for up to approximately $110 million in remaining milestones and tiered royalties under its Simcere license.
Connect Biopharma Holdings Limited reported that an independent Data Monitoring Committee completed a pre-specified interim efficacy analysis for its Phase 2 Seabreeze STAT asthma and COPD trials of rademikibart with no recommendation to change sample size, so enrollment will continue as planned. The committee regularly reviews safety and indicated no safety concerns, with no treatment-related serious or severe adverse events and no discontinuations due to adverse events so far. Connect Biopharma expects topline data from both Seabreeze STAT studies in mid-2026 and plans to meet with the U.S. Food and Drug Administration to seek alignment on a Phase 3 program. Under an existing Greater China license for rademikibart, the company remains eligible for up to approximately $110 million in future milestones plus tiered royalties up to low double-digit percentages.
Connect Biopharma reported 2025 full-year results showing it remains a clinical-stage company investing heavily in rademikibart. License and collaboration revenue was $64,000 for 2025, down from $26.0 million in 2024, reflecting the absence of prior-year upfront and milestone payments. Research and development expense rose to $37.8 million and general and administrative expense to $20.3 million, driving a wider net loss of $55.5 million, or $1.00 per share, compared with $15.6 million, or $0.28 per share, in 2024. Cash, cash equivalents and short-term investments were $44.3 million as of December 31, 2025. The company entered a $20.2 million private placement of 6,130,000 ordinary shares at $3.25 per share, which, together with existing cash, is expected to fund operations into the second half of 2027. Clinically, Connect reported positive Phase 1 IV rademikibart data in asthma and COPD with rapid FEV1 improvements of about 200–400 mL maintained through Day 29, alongside strong Phase 3 atopic dermatitis results from partner Simcere and ongoing Phase 2 Seabreeze STAT studies with topline data expected mid‑2026.
Connect Biopharma Holdings Limited entered a securities purchase agreement for a private placement of 6,130,000 ordinary shares at $3.25 per share, raising approximately $20.2 million in gross proceeds. The company plans to use the funds for clinical R&D, other development programs, working capital and general corporate purposes, and now expects its cash resources to fund operations into the second half of 2027.
The 8-K also highlights positive topline Phase 1 data for intravenous rademikibart in asthma and COPD, where a single 300 mg 2-minute IV push produced rapid and clinically meaningful FEV1 improvements of about 200–400 mL maintained through Day 29 with a favorable safety profile. In addition, partner Simcere reported Phase 3, 52-week results in atopic dermatitis, with high proportions of patients achieving deep skin clearance endpoints and safety comparable to placebo, supporting rademikibart’s potential as a best-in-class IL‑4Rα antibody.
Connect Biopharma Holdings Limited filed an 8-K stating it issued a press release announcing financial results for the three and nine months ended September 30, 2025. The press release is attached as Exhibit 99.1 and is incorporated by reference.
Per Item 2.02 and General Instruction B.2, the information, including Exhibit 99.1, is being furnished and not deemed filed under the Exchange Act. The company’s ordinary shares trade on the Nasdaq Global Market under the symbol CNTB.
Connect Biopharma Holdings Limited filed a current report describing open-market share purchases by two senior executives over the past year. Chief Executive Officer Barry D. Quart, Pharm.D., bought a total of 224,034 company shares in multiple transactions between September 2024 and September 2025. President David Szekeres purchased a total of 215,739 shares in transactions occurring between November 2024 and September 2025. The company states that all of these purchases complied with its Insider Trading Compliance Policy and characterizes this information as furnished under Regulation FD, not filed for liability purposes.
Connect Biopharma Holdings Limited filed a current report to note that it has released its latest financial results. On August 13, 2025, the company issued a press release covering its results for the three and six months ended June 30, 2025, and attached that release as an exhibit to this report.
The filing itself mainly serves as a formal notice that the earnings press release is available and clarifies that this information is being "furnished" rather than "filed" under securities laws. The report is signed by Lisa Peraza, Senior Vice President, Finance, on behalf of the company.
Connect Biopharma (CNTB) has initiated the termination of its American Depositary Receipt (ADR) program. On 18 Jul 2025 the company instructed Deutsche Bank Trust Company Americas to end the 18 Mar 2021 Deposit Agreement. All ADRs will be mandatorily cancelled on or about 2 Sep 2025 and exchanged on a 1-for-1 basis for the underlying ordinary shares.
Immediately after cancellation, CNTB plans a direct listing of its ordinary shares on Nasdaq under the same ticker “CNTB,” at which point the ADSs will be delisted. The Depositary will send formal notice to ADS holders describing the exchange mechanics.
The change affects capital-markets logistics rather than operations: it removes depositary fees, simplifies share structure and may broaden investor access, but requires successful coordination with Nasdaq and could create short-term trading friction. No financial results or guidance were provided.