– Company expects to report top-line data from China pivotal trial for lead drug candidate CBP-201 in atopic dermatitis in October 2022 –
– Company to Host Conference Call Today at 4:30 p.m. ET –
SAN DIEGO and TAICANG, China, Sept. 13, 2022 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global, clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, today announced financial results for the six-month period ended June 30 and recent corporate highlights.
“2022 has been a dynamic year for Connect Biopharma so far, with clinical progress in all three of our drug candidates, CBP-201, in atopic dermatitis (AD) (Global Phase 2b trial), CBP-307 (Phase 2), in ulcerative colitis (UC), and recently announced positive data for our third candidate, CBP-174, in pruritus, each of which has the potential to address large patient populations with persistent unmet medical needs,” said Zheng Wei, Ph.D., Co-founder and CEO of Connect Biopharma.
“With respect to our lead drug candidate, CBP-201, based on recent feedback from China’s Center for Drug Evaluation (CDE) on the CBP-201 China pivotal AD trial, we expect to report top-line data from the stage 1, 16-week treatment period, in October, which is earlier than we had anticipated. With these data, we plan to initiate discussions with the CDE which, if positive, could result in a New Drug Application (NDA) filing as early as 2024 for commercial launch in China. We remain confident that ongoing and future studies will continue to demonstrate the therapeutic potential of CBP-201 with a convenient dosing schedule for patients with AD as well as for other inflammatory-mediated diseases. To that end, we anticipate, by the end of this year, initiating our global CBP-201 Phase 3 trial in AD and in the first half of 2023, completing enrollment in the CBP-201 global Phase 2 trial in asthma,” concluded Dr. Zheng.
First Half 2022 Highlights
Completed and Anticipated Upcoming Milestones
First Half 2022 Financial Results
Conference Call and Webcast Details
To participate in today’s conference call or webcast, at 4:30 p.m. EDT/1:30 p.m. PDT today, please follow these options:
About Connect Biopharma Holdings Limited
Connect Biopharma is a U.S. and China-based clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases through the development of therapies derived from T cell research. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis and asthma. The Company’s second most advanced product candidate, CBP-307, is a modulator of S1P1 T cell receptor and is in development for the treatment of ulcerative colitis (UC). The Company’s third product candidate, CBP-174, is a peripherally acting antagonist of histamine receptor 3, for the treatment of pruritus associated with AD. For more information, please visit: https://www.connectbiopharm.com/.
Forward-Looking Statements
Connect Biopharma cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development or regulatory milestones, and the potential of such product candidates, including to achieve any benefit or profile or any product approval, as well as the ability of its current cash and investments position to support planned operations. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 31, 2022, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Connect Biopharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available from the SEC’s website ( www.sec.gov ) and on Connect Biopharma’s website ( www.connectbiopharm.com ) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
| CONNECT BIOPHARMA HOLDINGS LIMITED Unaudited Interim Condensed Consolidated Statements of Loss | |||||||||
| For Six Months Ended June 30, | |||||||||
| 2021 | 2022 | 2022 | |||||||
| RMB’000 | RMB’000 | USD’000(1) | |||||||
| Research and development expenses | (217,806 | ) | (340,775 | ) | (50,776 | ) | |||
| Administrative expenses | (47,965 | ) | (71,830 | ) | (10,703 | ) | |||
| Other income | 5,041 | 1,584 | 236 | ||||||
| Other (losses)/gains - net | (7,640 | ) | 9,241 | 1,378 | |||||
| Operating loss | (268,370 | ) | (401,780 | ) | (59,865 | ) | |||
| Finance income | 180 | 1,294 | 193 | ||||||
| Finance cost | (22 | ) | (58 | ) | (9 | ) | |||
| Finance income - net | 158 | 1,236 | 184 | ||||||
| Fair value loss of financial instruments with preferred rights | (674,269 | ) | - | - | |||||
| Loss before income tax | (942,481 | ) | (400,544 | ) | (59,681 | ) | |||
| Income tax expense | - | (737 | ) | (110 | ) | ||||
| Loss | (942,481 | ) | (401,281 | ) | (59,791 | ) | |||
| Loss attributable to： | |||||||||
| Owners of the Company | (942,481 | ) | (401,281 | ) | (59,791 | ) | |||
| Loss per share | |||||||||
| RMB | RMB | USD | |||||||
| Loss attributable to the owners of the Company | (942,481 | ) | (401,281 | ) | (59,791 | ) | |||
| Weighted average number of ordinary shares outstanding | 46,935,542 | 55,064,947 | 55,064,947 | ||||||
| Basic and diluted | (20.1 | ) | (7.3 | ) | (1.1 | ) | |||
| CONNECT BIOPHARMA HOLDINGS LIMITED Unaudited Interim Condensed Consolidated Balance Sheets | |||||||||
| December 31, | June 30, | June 30, | |||||||
| 2021 | 2022 | 2022 | |||||||
| RMB’000 | RMB’000 | USD’000(1) | |||||||
| ASSETS | |||||||||
| Non-current assets | |||||||||
| Property, plant and equipment | 59,337 | 66,700 | 9,938 | ||||||
| Right-of-use assets | 22,821 | 25,354 | 3,778 | ||||||
| Intangible assets | 560 | 529 | 79 | ||||||
| Investments: | |||||||||
| Financial assets at fair value through other comprehensive income | - | 149,681 | 22,303 | ||||||
| Other non-current assets | 18,806 | 5,606 | 835 | ||||||
| Total non-current assets | 101,524 | 247,870 | 36,933 | ||||||
| Current assets | |||||||||
| Cash and cash equivalents | 1,706,880 | 948,765 | 141,366 | ||||||
| Other receivable and prepayments | 47,255 | 47,832 | 7,127 | ||||||
| Investments: | |||||||||
| Financial assets at fair value through other comprehensive income | - | 330,673 | 49,270 | ||||||
| Total current assets | 1,754,135 | 1,327,270 | 197,763 | ||||||
| Total assets | 1,855,659 | 1,575,140 | 234,696 | ||||||
| LIABILITIES | |||||||||
| Non-current liabilities | |||||||||
| Lease liabilities | 163 | 2,248 | 335 | ||||||
| Deferred income | 5,000 | 4,816 | 718 | ||||||
| Total non-current liabilities | 5,163 | 7,064 | 1,053 | ||||||
| Current liabilities | |||||||||
| Lease liabilities | 630 | 1,518 | 226 | ||||||
| Trade payables | 81,195 | 101,627 | 15,142 | ||||||
| Other payables and accruals | 32,840 | 35,441 | 5,281 | ||||||
| Total current liabilities | 114,665 | 138,586 | 20,649 | ||||||
| Total liabilities | 119,828 | 145,650 | 21,702 | ||||||
| Net assets | 1,735,831 | 1,429,490 | 212,994 | ||||||
| SHAREHOLDERS’ EQUITY | |||||||||
| Share capital | 66 | 66 | 10 | ||||||
| Share premium | 4,094,434 | 4,094,434 | 610,072 | ||||||
| Treasury shares | (1,164 | ) | (1,164 | ) | (173 | ) | |||
| Share-based compensation reserve | 61,904 | 89,798 | 13,380 | ||||||
| Other reserves | (41,244 | ) | 25,802 | 3,843 | |||||
| Accumulated losses | (2,378,165 | ) | (2,779,446 | ) | (414,138 | ) | |||
| Total shareholders’ equity | 1,735,831 | 1,429,490 | 212,994 | ||||||
| Total liabilities and shareholders’ equity | 1,855,659 | 1,575,140 | 234,696 | ||||||
| (1) | Translations of the consolidated balance sheet and the consolidated statement of loss from RMB into USD as of and for the six-month period ended June 30, 2022, are solely for the convenience of the readers and calculated at the rate of USD1.00=RMB 6.7114, representing the exchange rate as of June 30, 2022, set forth in the China Foreign Exchange Trade System. No representation is made that the RMB amounts could have been, or could be, converted, realized or settled into USD at that rate, or at any other rate, on June 30, 2022, or any other date. |
INVESTOR and MEDIA CONTACT:
Ina McGuinness
805.427.1372
imcguinness@connectpharm.com
Corporate Contacts:
info@connectpharm.com