Announced new U.S.-based leadership with the appointment of Barry Quart, Pharm.D. as Chief Executive Officer (CEO) and David Szekeres as President
Connect's new management is currently evaluating the future clinical development strategy for rademikibart
As part of Connect's transformation into a U.S.-centric company, the Company will be significantly reducing its presence in China
Cash and cash equivalents of $110.2 million expected to support planned operations into at least the first half of 2027
SAN DIEGO, CA, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma," "Connect" or the "Company"), a U.S.-headquartered global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases, today reported financial results for the six months ended June 30, 2024 and provided a business update.
"Having had the opportunity to thoroughly review all the clinical data generated with rademikibart, I continue to be incredibly excited about this potential best-in-class competitor to dupilumab," said Barry Quart, Pharm.D., CEO and Director of Connect. "In parallel, we continue to take steps towards transforming into a U.S.-centric company and significantly reducing our footprint in China. We are excited about the Company's transformation and look forward to unveiling our new strategy for rademikibart in the near future."
First Half 2024 and Recent Highlights
Leadership and Board of Directors Appointments
In June 2024, the Board of Directors (the "Board") appointed Barry Quart, Pharm.D., an industry leader, as Chief Executive Officer and member of the Board, and David Szekeres, an experienced life science executive, as President. Dr. Quart brings over 30 years of extensive experience serving in leadership positions in biotechnology and pharmaceutical companies and developing innovative pharmaceutical products. He has personally led several early-stage biotech companies through late-stage clinical development, with nine U.S. Food and Drug Administration (FDA) drug approvals.
In June 2024, Kleanthis G. Xanthopoulos, Ph.D. was appointed as Chairperson of the Board.
In February 2024, James Zuie-chin Huang, M.B.A., a successful entrepreneur, investor, and key opinion leader in the healthcare sector, was appointed to the Board.
Clinical Programs Highlights
The Company received favorable feedback from the FDA in Q2 2024 regarding potential Phase 3 registrational programs for rademikibart in both asthma and atopic dermatitis (AD). The Company is considering whether advancing rademikibart into a Phase 3 program is the appropriate next step versus other development opportunities for rademikibart, which could be completed without additional financing.
Simcere Pharmaceutical Co., Ltd. ("Simcere"), Connect's partner in Greater China who holds responsibility for future development and New Drug Application submission of rademikibart, has announced the initiation of Phase 3 trials in China in moderate-to-severe AD and asthma.
Presented a late-breaking poster presentation on the positive results from the rademikibart global Phase 2b trial in patients with moderate-to-severe asthma at the American Thoracic Society (ATS) 2024 International Conference.
Corporate Highlights
Completed a technology transfer of the manufacturing process for rademikibart to a U.S.-based contract manufacturer, allowing the Company to significantly reduce manufacturing expenses for the remainder of 2024 and 2025.
As part of the transition to a U.S.-centric company, Connect has reduced its China workforce over the past 12 months by approximately 15% as of June 30, 2024, with further reductions in the China workforce expected by end of year.
Financial Results for the First Half 2024
Cash, cash equivalents and short-term investments were $110.2 million as of June 30, 2024, compared with $118.7 million as of December 31, 2023. The decrease was mainly due to cash used to advance the Company's clinical programs and fund its operations, offset by partnership payments received from Simcere. The Company has continued to control spend, allowing it to extend its cash runway. Based on its current operating plans, management believes the Company has sufficient cash and investments to support planned operations into at least the first half of 2027.
Revenue for the six months ended June 30, 2024, totaled $24.1 million, as the Company began recognizing revenue from the license and collaboration agreement executed with Simcere in November 2023.
R&D expenses for the six months ended June 30, 2024, totaled $13.3 million, compared with $26.6 million for the six months ended June 30, 2023, a decrease of $13.3 million primarily due to fewer clinical trials, less drug product manufacturing activity, and lower personnel costs due to fewer research and development headcount compared to the prior period.
Administrative expenses totaled $8.3 million for the six months ended June 30, 2024, compared with $8.1 million for the six months ended June 30, 2023. The increase in administrative expenses was primarily due to severance costs associated with employee headcount reductions or transitions.
Net income totaled $7.6 million for the six months ended June 30, 2024, compared with a net loss of $30.5 million for the six months ended June 30, 2023.
Connect Biopharma Holdings Ltd.Condensed Consolidated Income Statement Data(Unaudited)
For Six Months Ended June 30,
2023
2024
USD'000
USD'000
(in thousands, except per share data)
Revenue from contracts with customers
$
-
$
24,116
Total revenue
-
24,116
