1. SAN DIEGO, CA and TAICANG, SUZHOU, China, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first subject has been dosed in a Phase 2 trial evaluating CBP-201 in adult patients with chronic rhinosinusitis with nasal polyps ("CRSwNP").

    This multi-center, randomized, double-blind, placebo-controlled trial was designed to evaluate the effect of CBP-201 administered as a subcutaneous injection ("SC") on a background of mometasone furoate nasal spray…

    SAN DIEGO, CA and TAICANG, SUZHOU, China, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first subject has been dosed in a Phase 2 trial evaluating CBP-201 in adult patients with chronic rhinosinusitis with nasal polyps ("CRSwNP").

    This multi-center, randomized, double-blind, placebo-controlled trial was designed to evaluate the effect of CBP-201 administered as a subcutaneous injection ("SC") on a background of mometasone furoate nasal spray ("MFNS)" in reducing endoscopic nasal polyp score ("NPS") and nasal congestion/obstruction score ("NCS") severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid ("INCS") therapy in comparison to placebo. The trial is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks and is expected to enroll approximately 140 patients with CRSwNP across approximately 60 clinical sites in the United States, China, European Union and Eurasian Economic Union (NCT04783389).

    "CRSwNP is a chronic inflammatory condition that can cause long-term symptoms that negatively affect patients' health-related quality of life," says Dr. Rodney J. Schlosser, M.D., Director of Rhinology and Sinus Surgery at the Medical University of South Carolina, Investigator in the Phase 2 study. "Current treatment options for CRSwNP are limited, some patients do not respond well and there is an unmet need for therapies that can prove to be effective and safe in controlling symptoms and minimizing reoccurrences."

    "The initiation of this global clinical trial in CRSwNP expands our ongoing research programs exploring the potential of CBP-201 in patients with atopic dermatitis and asthma, and reinforces our commitment to developing treatment solutions for patients suffering with chronic type 2 inflammatory diseases where IL-4 and IL-13 are known to play critical roles," said Zheng Wei, PhD, Co-founder and CEO of Connect Biopharma.

    About Chronic Rhinosinusitis with Nasal Polyps

    Chronic rhinosinusitis (CRS), which is characterized by chronic inflammation of the nasal mucosa and paranasal sinuses, is a common condition with an estimated prevalence of 5-12% of the general population. Approximately 25-30% of individuals with CRS develop nasal polyps, which are growths that occur in the nasal passages and sinuses and are frequently associated with asthma, allergic rhinitis and chronic rhinosinusitis. As nasal polyps increase in size and/or number, they can interfere with normal breathing and may lead to a loss of sense of smell. In some cases, nasal polyps may need to be removed surgically. Patients with CRSwNP may experience significant morbidity and can have decreased quality of life. Despite the availability of an injectable biologic for nasal polyps due to chronic rhinosinusitis, many patients continue to have unmet medical need.

    About CBP-201

    CBP-201, discovered internally using Connect Biopharma's proprietary Immune Modulation Technology Platform, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases including atopic dermatitis (AD). CBP-201 has shown a favorable safety and efficacy profile in a Phase 1b clinical trial in adult patients with moderate-to-severe atopic dermatitis, suggesting a potential for a differentiated efficacy profile compared with data from clinical trials of the current biologic standard of care therapy. CBP-201 is currently being evaluated in a global Phase 2b trial in adult patients with moderate-to-severe atopic dermatitis (NCT04444752), in a China specific pivotal trial in adults with moderate-to-severe atopic dermatitis (NCT05017480), in a Phase 2b trial in adult patients with moderate-to-severe persistent asthma (NCT04773678) and in a Phase 2b trial in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (NCT04783389).

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD), Asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in clinical trials for ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we have started the clinical development of CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with AD.

    With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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 statements regarding the potential of CBP-201 to achieve a differentiated profile to address the unmet needs of patients with CRSwNP and the size, the duration, and/or the results of the Company's Phase 2 clinical trial evaluating CBP-201 in adult patients with CRSwNP. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.

    IR/PR Contacts: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com



    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  2. SAN DIEGO, CA and TAICANG, SUZHOU, China, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first patient has been dosed in a China specific pivotal trial evaluating CBP-201 in adults with moderate-to-severe atopic dermatitis.

    This multicenter, randomized, double-blind, parallel group, placebo-controlled trial was designed to assess the efficacy and safety of up to two doses of CBP-201 administered subcutaneously (SC) to eligible patients with…

    SAN DIEGO, CA and TAICANG, SUZHOU, China, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first patient has been dosed in a China specific pivotal trial evaluating CBP-201 in adults with moderate-to-severe atopic dermatitis.

    This multicenter, randomized, double-blind, parallel group, placebo-controlled trial was designed to assess the efficacy and safety of up to two doses of CBP-201 administered subcutaneously (SC) to eligible patients with moderate to severe atopic dermatitis. The trial is expected to enroll approximately 255 patients across 55 clinical sites in China and is divided into an initial treatment period of 16 weeks, a further maintenance period of 36 weeks and a follow-up period of 8 weeks (NCT05017480).

    "Atopic dermatitis is a chronic inflammatory skin disease that significantly impacts patients' quality of life, and its prevalence in China is increasing, leading to a growing burden for patients," said Dr. Jianzhong Zhang, MD, Principal Investigator and Director of the Dermatology Disease Department at Peking University People's Hospital. "Despite the recent approval of a new biologic treatment in China, many patients do not achieve a return to clear and normal skin. It is hoped that CBP-201, which is capable of blocking both IL-4 and IL-13 that drive the inflammation associated with atopic dermatitis may bring additional benefit to patients, particularly in measures of efficacy and possibly in lowering the burden of treatment through a need for fewer injections."

    "The commencement of this China specific clinical trial of CBP-201 in moderate to severe atopic dermatitis is a significant step for Connect as we look to advance the development pathway for CBP-201," said Dr. Pauline Li, MD, Head of Clinical Development, Asia for Connect Biopharma. "While we are advancing CBP-201 across multiple indications in global trials, this trial, if successful, could accelerate the availability of CBP-201 to patients in China."

    About Atopic Dermatitis

    Atopic dermatitis (AD), which has an estimated lifetime prevalence of up to 20% and is increasing globally, is the most commonly diagnosed chronic inflammatory skin disorder. It is characterized by skin barrier disruption and immune dysregulation. Estimates of prevalence of AD in China show this increasing over time and recent longitudinal studies have reported a dermatologist diagnosed prevalence of 7.8% in Chinese outpatients visiting tertiary hospitals. In the United States, it is estimated that 26.1 million people have AD, of which 6.6 million have moderate-to-severe disease. Further, over 58% of adults with moderate-to-severe AD have disease which physicians consider to be inadequately controlled by approved therapeutic modalities, including topical anti-inflammatory agents and systemic agents.

    About CBP-201

    CBP-201, discovered using Connect Biopharma's proprietary Immune Modulation Technology Platform, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases including atopic dermatitis (AD). CBP-201 has shown a favorable safety and efficacy profile in a Phase 1b clinical trial in adult patients with moderate-to-severe atopic dermatitis, suggesting a potential for a differentiated efficacy profile compared with data from clinical trials of the current biologic standard of care therapy. CBP-201 is currently being evaluated in several Phase 2b clinical trials: in adult patients with moderate-to-severe atopic dermatitis (NCT04444752), in adult patients with moderate-to-severe persistent asthma (NCT04773678), and in adult patients for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) (NCT04783389).

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD), asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With current headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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 statements regarding the potential of CBP-201 to achieve a differentiated profile to address the unmet needs of patients with AD and the size, the duration, and the results of the Company's China only pivotal trial and phase 2 clinical trials of CBP-201. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.

    IR/PR Contacts: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com



    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  3. - On Track to Report CBP-201 Phase 2B Top-Line Data Evaluating Moderate-to-Severe Atopic Dermatitis (AD) in Q4 of 2021 -

    - Cash Balance of RMB 2,025.0 Million (USD 313.5 Million) at June 30, 2021 -

    SAN DIEGO, CA and TAICANG, SUZHOU, China, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced financial results for the six months ended June 30, 2021 and recent corporate highlights.

    "The first half of 2021 marked the achievement of a number of key milestones…

    - On Track to Report CBP-201 Phase 2B Top-Line Data Evaluating Moderate-to-Severe Atopic Dermatitis (AD) in Q4 of 2021 -

    - Cash Balance of RMB 2,025.0 Million (USD 313.5 Million) at June 30, 2021 -

    SAN DIEGO, CA and TAICANG, SUZHOU, China, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced financial results for the six months ended June 30, 2021 and recent corporate highlights.

    "The first half of 2021 marked the achievement of a number of key milestones for Connect, including the transition to a public company with our oversubscribed Nasdaq Initial Public Offering in March 2021, strong execution and progress on our development programs with our three lead assets now in the clinic targeting multiple chronic inflammatory diseases, and advancing our operational capabilities as we continue to attract key talent in both China and the U.S.," said Zheng Wei, PhD, Co-founder and CEO of Connect Biopharma. "For the remainder of 2021, despite the uncertainties related to the COVID-19 pandemic, we remain confident in executing against our corporate strategy and we look forward to important clinical trial data readouts toward the end of this year that we believe will validate our approach in developing potential first-in-class or best-in-class therapies for T cell-driven inflammatory diseases."

    First Half 2021 and Recent Operating Highlights

    • Completed successful listing on Nasdaq: In March 2021, Connect Biopharma completed an IPO of American Depositary Shares on the Nasdaq Global Select Market and commenced trading under the ticker symbol "CNTB". The Company raised net proceeds of approximately USD 204.5 million.
    • Completed enrollment of Phase 2 trial of CBP-201 in moderate-to-severe atopic dermatitis (AD): In April 2021, Connect Biopharma completed full enrollment of the Phase 2 clinical trial evaluating CBP-201 in adult patients with moderate-to-severe AD. The global, randomized, double-blind, placebo-controlled, dose-ranging clinical trial is intended to assess the efficacy, safety, and pharmacokinetics (PK) profile of CBP-201 in 220 subjects and is being conducted at 60 sites across the U.S., China, Australia, and New Zealand. CBP-201 or placebo was administered to eligible adult subjects with moderate-to-severe AD for 16 weeks with eight weeks of follow up.
    • Dosed first patient in Phase 2 trial of CBP-201 in moderate-to-severe persistent asthma: In May 2021, dosed the first patient in a global Phase 2 clinical trial evaluating CBP-201 in adults with moderate-to-severe persistent asthma. This multicenter, randomized, double-blind, parallel group, placebo-controlled trial was designed to assess the efficacy and safety of two doses of CBP-201 administered subcutaneously (SC) to eligible patients with moderate to severe persistent asthma with Type 2 inflammation. The trial is expected to enroll approximately 300 patients across 80 clinical sites in the United States, China, the European Union, the United Kingdom, Ukraine and South Korea and is divided into a treatment period of 24 weeks and a follow-up period of eight weeks.
    • Dosed first subject in Phase 1 trial of CBP-174: In May 2021, Connect Biopharma dosed the first subject in a Phase 1 clinical trial evaluating CBP-174 in the treatment of chronic inflammatory pruritus. This randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, aims to evaluate the safety, tolerability and PK of CBP-174 in different dose levels given orally, compared to placebo. Following the single dose, each subject will be followed for up to seven days.
    • Expanded senior leadership team: Announced that Mr. Yau Wing Yiu (Felix) joined Connect Biopharma as Vice President, Finance and Mr. Jiang Bian as General Counsel and Chief Compliance Officer.
    • Appointed Jean Liu, J.D., as Independent Director to the Board: Ms. Liu is an Executive Vice President, Legal Affairs, General Counsel and Secretary of Seagen Inc., a targeted cancer therapeutic company.

    Anticipated Upcoming Milestones

    • On track to report top-line results from the global Phase 2b trial for CBP-201 evaluating moderate-to-severe AD in the fourth quarter of 2021.
    • On track to dose first patient in the global Phase 2 trial of CBP-201 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the second half of 2021.
    • Plan to initiate a China standalone phase 2 trial for CBP-201 in AD patients in the second half of 2021.
    • On track to report top-line results from the phase 1 trial of CBP-174 evaluating the safety and pharmacokinetics in healthy volunteers in the second half of 2021.
    • Anticipate reporting the global CBP-307 phase 2b top-line data evaluating ulcerative colitis (UC) in the first quarter of 2022.

    First Half 2021 Financial Results

    • Cash and cash equivalents were RMB 2,025.0 million (USD 313.5 million) as of June 30, 2021, compared to RMB 1,010.1 million as of December 31, 2020. The increase in cash and cash equivalents was mainly due to proceeds received from the IPO in March 2021.
    • Research and development expenses increased to RMB 217.8 million (USD 33.7 million) for the six months ended June 30, 2021, from RMB 59.0 million in the same period in 2020. This increase was driven primarily by higher clinical trials related expenses, personnel expenses, and lab-related expenses.
    • Administrative expenses increased to RMB 48.0 million (USD 7.4 million) for the six months ended June 30, 2021, from RMB 7.1 million in same period in 2020. The increase was primarily due to higher professional fees, stock-based compensation expenses, director and officer insurance expenses, additional personnel costs and market research expenses.
    • Net loss was approximately RMB 942.5 million (USD 145.9 million) for the six months ended June 30, 2021, compared to RMB 75.2 million in the same period in 2020.

    Conference Call and Webcast

    Connect Biopharma will host a conference call and webcast to review its first half 2021 results on Wednesday, September 1, 2021, beginning at 8:30 am Eastern Time.

    The conference call can be accessed using the following information:

    Webcast: https://edge.media-server.com/mmc/p/d8b5cvaf 

    U.S.: 844-646-2698 

    Outside of U.S.: 918-922-6903 

    Conference ID: 5567966

    A replay of the call will be available for two weeks by dialing 855-859-2056 for U.S. callers or 404-537-3406 for international callers and using Conference ID: 5567966. The webcast will also be available in the "Investors" section of the Company's website following the completion of the call.

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD) and asthma and in development for CRSwNP. Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of UC and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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 statements regarding the timing of initiation and dosing of clinical trials and the timing of clinical data readouts from such trials and whether such data will validate the Company's approach in developing potential therapies. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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,

     2020  2021  2021

     
     RMB'000  RMB'000  USD'000 (1) 
    Research and development expenses(59,047) (217,806) (33,716)
    Administrative expenses(7,086) (47,965) (7,424)
    Other income2,715  5,041  780 
    Other gains/(losses) - net878  (7,640) (1,183)
             
    Operating loss(62,540) (268,370) (41,543)
             
    Finance income569  180  28 
    Finance cost(19) (22) (4)
             
    Finance income - net550  158  24 
    Fair value loss of financial instruments with preferred rights(13,217) (674,269) (104,374)
             
    Loss before income tax(75,207) (942,481) (145,893)
    Income tax expense     
             
    Net loss(75,207) (942,481) (145,893)
             
    Net loss attributable to:        
    Owners of the Company(75,207) (942,481) (145,893)
             
             
     RMB   RMB  USD 
    Net loss attributable to:        
    Basic and diluted(4.4) (20.1) (3.1)
             

    Connect Biopharma Holdings Limited

    Unaudited Interim Condensed Consolidated Balance Sheets

     December 31,  June 30,  June 30, 
     2020

      2021

      2021

     
     RMB'000  RMB'000  USD'000 (1) 
    ASSETS        
             
    Non-current assets        
    Property, plant and equipment6,939  24,524  3,796 
    Right-of-use assets929  23,358  3,616 
    Intangible assets342  284  43 
    Other non-current assets19,860  27,614  4,275 
             
    Total non-current assets28,070  75,780  11,730 
             
    Current assets        
    Cash and cash equivalents1,010,076  2,025,046  313,470 
    Other receivable and prepayments33,655  72,900  11,285 
    Financial assets at fair value through profit or loss13,068     
             
    Total current assets1,056,799  2,097,946  324,755 
             
    Total assets1,084,869  2,173,726  336,485 
             
    LIABILITIES        
    Non-current liabilities        
    Lease liabilities309  482  75 
    Financial instruments with preferred rights2,071,508     
             
    Total non-current liabilities2,071,817  482  75 
             
    Current liabilities        
    Lease liabilities604  615  95 
    Trade payables24,638  65,628  10,159 
    Other payables and accruals12,755  24,383  3,774 
             
    Total current liabilities37,997  90,626  14,028 
             
    Total liabilities2,109,814  91,108  14,103 
             
    Net (liabilities)/assets(1,024,945) 2,082,618  322,382 
             
    SHAREHOLDERS' (DEFICIT)/EQUITY        
    Share capital24  66  10 
    Share premium41,466  4,092,298  633,473 
    Treasury shares(3) (3)  
    Share-based compensation reserve6,602  24,608  3,809 
    Other reserves(1,693) (20,529) (3,178)
    Accumulated losses(1,071,341) (2,013,822) (311,732)
             
    Total shareholders' (deficit)/equity(1,024,945) 2,082,618  322,382 
             
    Total liabilities and shareholders' (deficit)/equity1,084,869  2,173,726  336,485 
             

    (1) Translations of the unaudited interim condensed consolidated balance sheet and the unaudited interim condensed consolidated statement of loss from RMB into USD as of and for the six months ended June 30, 2021 are solely for the convenience of the readers and calculated at the rate of USD 1.00 = RMB 6.4601, representing the exchange rate as of June 30, 2021 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, 2021.

    IR/PR CONTACTS: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com

    Erich Sandoval (Media)

    +1-(646) 871-8482 or +1-(917) 497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  4. SAN DIEGO and TAICANG, SUZHOU, China, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that it will report financial results for the first half ended June 30, 2021 after the market closes on Tuesday, August  31, 2021. Connect Biopharma management will host a webcast and conference call to review its results on Wednesday, September 1, 2021, beginning at 8:30 am Eastern Time.

    The conference call can be accessed using the following information:
    Webcast

    SAN DIEGO and TAICANG, SUZHOU, China, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that it will report financial results for the first half ended June 30, 2021 after the market closes on Tuesday, August  31, 2021. Connect Biopharma management will host a webcast and conference call to review its results on Wednesday, September 1, 2021, beginning at 8:30 am Eastern Time.

    The conference call can be accessed using the following information:

    Webcasthttps://edge.media-server.com/mmc/p/d8b5cvaf

    U.S.: 844-646-2698

    Outside of U.S.: 918-922-6903

    Conference ID: 5567966

    A replay of the call will be available for two weeks by dialing 855-859-2056 for U.S. callers or 404-537-3406 for international callers and using Conference ID: 5567966. The webcast will also be available in the "Investors" section of the Company's website following the completion of the call.

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD) and asthma and in development for chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at www.connectbiopharm.com.

    IR/PR CONTACTS: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com



    Erich Sandoval (Media)

    +1-(646) 871-8482 or +1-(917) 497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  5. TAICANG, SUZHOU, China and SAN DIEGO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced Mr. Jiang Bian has joined the Company as General Counsel & Chief Compliance Officer, effective August 20, 2021. In his role, Mr. Bian will oversee Connect Biopharma's legal function and will report to Dr. Zheng Wei, Co-founder and CEO. The hiring of Mr. Bian is an important step in filling out the Company's Executive Leadership and advancing the organizational growth…

    TAICANG, SUZHOU, China and SAN DIEGO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced Mr. Jiang Bian has joined the Company as General Counsel & Chief Compliance Officer, effective August 20, 2021. In his role, Mr. Bian will oversee Connect Biopharma's legal function and will report to Dr. Zheng Wei, Co-founder and CEO. The hiring of Mr. Bian is an important step in filling out the Company's Executive Leadership and advancing the organizational growth strategy.

    Separately, the Company announced a change to the composition of its Board of Directors, with the appointment of Jean Liu, J.D., Executive Vice President, Legal Affairs, General Counsel and Secretary of Seagen Inc., a targeted cancer therapeutic company. Ms. Liu joins as an Independent Director to the Company.

    "Jiang has strong experience both as a senior counsel in healthcare and biopharmaceutical companies as well as at a law firm representing global public companies and emerging life science and technology companies in licensing, intellectual property and corporate issues. He will be a key addition to our executive management team as we continue our progress as newly public company," said Dr. Zheng Wei.

    Mr. Bian joins Connect Biopharma from Guardant Health, Inc., a publicly traded precision oncology diagnostics company, based in Redwood City, California, where he served as Senior Counsel. Prior to Guardant Health, Mr. Bian was with Shartsis Friese LLP where he focused on corporate and technology licensing areas of legal advisory. Mr. Bian also held positions of increasing responsibility, including Senior Counsel at Pieris Pharmaceuticals, Inc., a publicly traded biotechnology company. He received his LL.B. from Southwest University of Political Science and Law, Chongqing, China, and his LL.M. in Intellectual Property and J.D. from George Washington University Law School.

    "I am thrilled to be joining Connect and lead its global legal efforts as a part of a team that has made such significant progress over the past 18 months and with their recent IPO," said Mr. Bian. "I look forward to working with Wei and the whole Connect team to achieve even greater results."

    Commenting on the appointment to the Board, Dr. Wubin Pan, Co-founder, President and Chairman of the Board, said, "We are delighted to have Ms. Jean Liu join our Board of Directors as we continue to deliver on our growth strategy. Jean is a highly respected biotech executive with more than twenty years of experience working with leading biotech companies in high-growth transformations through her deep expertise across corporate governance and strategic business transactions. Liu's counsel will be a welcomed addition to our Board."

    "Connect's pipeline progress in developing novel candidates targeting inflammatory diseases with high unmet medical need has been truly impressive," said Ms. Liu. "I am excited for the opportunity to work closely with the team to continue Connect's successful growth trajectory."

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD) and asthma and in development for chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.

    IR/PR Contacts: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com



    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  6. SAN DIEGO and TAICANG, SUZHOU, China, May 26, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that Dr. Zheng Wei, Co-Founder & CEO of Connect Biopharma, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 10:00 am ET.

    A live webcast of this fireside chat will be available on the Company's Investor Relations page accessible here: https://investors.connectbiopharm.com/. A replay will be available on…

    SAN DIEGO and TAICANG, SUZHOU, China, May 26, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that Dr. Zheng Wei, Co-Founder & CEO of Connect Biopharma, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 10:00 am ET.

    A live webcast of this fireside chat will be available on the Company's Investor Relations page accessible here: https://investors.connectbiopharm.com/. A replay will be available on the Company's website following the event.

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD) and asthma and in development for chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at www.connectbiopharm.com.

    IR/PR CONTACTS: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com

    Erich Sandoval (Media)

    +1-(646) 871-8482 or +1-(917) 497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  7. Development program exploring the potential of CBP-174 in the treatment of chronic inflammatory pruritus

    SAN DIEGO and TAICANG, SUZHOU, China, May 25, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first subject has been dosed in a Phase I trial evaluating CBP-174 in healthy adult subjects.

    This randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, aims to evaluate the safety, tolerability and pharmacokinetics…

    Development program exploring the potential of CBP-174 in the treatment of chronic inflammatory pruritus

    SAN DIEGO and TAICANG, SUZHOU, China, May 25, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first subject has been dosed in a Phase I trial evaluating CBP-174 in healthy adult subjects.

    This randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, aims to evaluate the safety, tolerability and pharmacokinetics of CBP-174 in different dose levels given orally, compared to placebo. Following the single dose, each subject will be followed for up to seven days (NCT04811469).

    "The effective management of pruritus associated with atopic dermatitis and other inflammatory skin conditions remains a significant unmet medical need, and the advancement of this novel oral agent into Phase I trial is an important step forward in the development of potential therapies," said Zheng Wei, PhD, Co-founder and CEO of Connect Biopharma. "We believe that CBP-174's novel mechanism of action and rapid onset of action has the potential to complement the anti-pruritic effect of disease-modifying agents already approved for inflammatory skin diseases."

    About Chronic Inflammatory Pruritus

    Chronic inflammatory pruritus is an unpleasant and often persistent itch that can last more than six weeks in duration and is often caused by inflamed skin lesions associated with diseases such as atopic dermatitis (AD). Due to the significant impact that pruritus has on quality of life, its severity is often measured by patients based on intensity of pruritus rather than skin lesions themselves. Common antihistamine drugs primarily target the histamine 1 receptor (H1R) and lead to alleviation of itch in part by blocking H1R on peripheral nerves. However, many types of chronic itch cannot be relieved by current antihistamine treatments that target H1R. Despite currently available treatments for AD, an estimated 40% to 50% of AD patients have inadequate relief of their pruritus and are in need of new, efficacious pruritus therapies.

    About CBP-174

    CBP-174 is a highly potent, orally active, peripherally restricted antagonist of histamine receptor 3 (H3R), designed not to penetrate the blood brain barrier. In preclinical studies, CBP-174 was both well-tolerated and demonstrated significant reductions in scratching bouts within the first 30 minutes of oral or topical dosing, which could potentially translate to rapid relief of itch in the clinic.

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD) and asthma and in development for chronic rhinosinusitis with nasal polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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 statements regarding the potential of CBP-174 to address the unmet needs of patients with chronic inflammatory pruritus. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.

    IR/PR Contacts:

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com

    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  8. SAN DIEGO and TAICANG, China, May 12, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first patient has been dosed in a Phase 2 trial evaluating CBP-201 in adults with moderate-to-severe persistent asthma.

    This multicenter, randomized, double-blind, parallel group, placebo-controlled trial was designed to assess the efficacy and safety of two doses of CBP-201 administered subcutaneously (SC) to eligible patients with moderate to severe persistent asthma…

    SAN DIEGO and TAICANG, China, May 12, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that the first patient has been dosed in a Phase 2 trial evaluating CBP-201 in adults with moderate-to-severe persistent asthma.

    This multicenter, randomized, double-blind, parallel group, placebo-controlled trial was designed to assess the efficacy and safety of two doses of CBP-201 administered subcutaneously (SC) to eligible patients with moderate to severe persistent asthma with Type 2 inflammation. The trial is expected to enroll approximately 300 patients across 80 clinical sites in the United States, China, European Union, the United Kingdom, Ukraine and South Korea and is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks (NCT04773678).

    "Beginning enrollment on the CBP-201 clinical trial offers hope in the pursuit of new, effective treatments for severe asthma," said Dr. Edward M. Kerwin, MD, Founder and Senior Medical Director of the Clinical Research Institute, Allergy and Asthma Center and Altitude Clinical Consulting, and member of the Connect Biopharma Scientific Advisory Board. "The patients that will be enrolled are those experiencing severe exacerbations requiring oral corticosteroid bursts, very high dose inhaled corticosteroids (ICS), and often requiring emergency department visits or hospitalizations. CBP-201 has been designed to use a validated mechanism as a biologic that blocks IL-4 receptor alpha, which would make it capable of blocking both IL-4 and IL-13 that drive allergic asthmatic inflammation."

    "Initiation of CBP-201 in persistent asthma is a significant step in our plan to expand our clinical programs into important diseases mediated by the dysregulation of the IL-4 and IL-13 cytokines. Many patients with moderate-to-severe asthma continue to have unmet need and could benefit from additional treatment options," said Zheng Wei, PhD, Co-founder and CEO of Connect Biopharma. "We see strong potential for CBP-201 to become a treatment that can help these patients to address significant unmet medical needs, and ultimately to enhance their quality of life."

    About Type 2 Inflammatory Asthma

    Type 2 inflammation, which occurs in more than 80% of children and the majority of adults with asthma, is an important molecular mechanism that gives rise to asthma symptoms. Type 2 inflammation is mediated by type 2 helper T-cells (TH2), which secrete inflammatory cytokines including IL-3, IL-4, L-5, IL-9 and IL-13. While corticosteroids have been a pillar of therapy for patients with type 2 inflammatory asthma, they are associated with multiple local and systemic side effects. Novel therapies that can inhibit aberrant TH2 activity with greater specificity would have the potential to improve the care and outcomes of patients with type 2 inflammatory asthma.

    About CBP-201

    CBP-201, discovered internally using Connect Biopharma's proprietary Immune Modulation Technology Platform, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases including atopic dermatitis (AD). CBP-201 has shown a favorable safety and efficacy profile in a Phase 1b clinical trial in adult patients with moderate-to-severe atopic dermatitis, suggesting a potential for a differentiated efficacy profile compared with data from clinical trials of the current biologic standard of care therapy. CBP-201 is currently being evaluated in a Phase 2b trial in adult patients with moderate-to-severe atopic dermatitis (NCT04444752), in a Phase 2b trial in adult patients with moderate-to-severe persistent asthma (NCT04773678) and is in development for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and is currently being evaluated in clinical trials for the treatment of atopic dermatitis (AD) and Asthma and in development for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1) that is in development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Furthermore, we are developing CBP-174, a peripherally restricted antagonist of histamine receptor 3, for the treatment of pruritus associated with skin inflammation.

    With current headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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 statements regarding the potential of CBP-201 to achieve a differentiated profile to address the unmet needs of patients with Asthma and the size and timing of the results of the Company's phase 2 clinical trial evaluating CBP-201 in adult patients with moderate-to-severe persistent asthma. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.

    IR/PR Contacts: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com



    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  9. SAN DIEGO and TAICANG, China, April 08, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that it has completed full enrollment of the phase 2 clinical trial evaluating CBP-201 in adult patients with moderate-to-severe Atopic Dermatitis (AD).

    The global, randomized, double-blind, placebo-controlled, dose-ranging clinical trial to assess the efficacy, safety, and pharmacokinetics (PK) profile of CBP-201, was designed to enroll 220 subjects and is being conducted…

    SAN DIEGO and TAICANG, China, April 08, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) ("Connect Biopharma" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced that it has completed full enrollment of the phase 2 clinical trial evaluating CBP-201 in adult patients with moderate-to-severe Atopic Dermatitis (AD).

    The global, randomized, double-blind, placebo-controlled, dose-ranging clinical trial to assess the efficacy, safety, and pharmacokinetics (PK) profile of CBP-201, was designed to enroll 220 subjects and is being conducted at 60 sites across the US, China, Australia, and New Zealand. CBP-201 or placebo was administered to eligible adult subjects with moderate-to-severe AD for 16 weeks with 8 weeks of follow up (NCT04444752).

    "The completion of enrollment of the CBP-201 global phase 2 trial in patients with moderate-to-severe AD is an important step for Connect and our lead clinical program," said Zheng Wei, PhD, Co-founder and CEO of Connect Biopharma. "A significant unmet need still exists for patients and we believe that CBP-201 has the potential to show a differentiated profile to address it. We are optimistic that the results from this study, expected in the second half of this year, will continue to support our hypothesis."

    About Atopic Dermatitis

    Atopic dermatitis (AD), which has an estimated lifetime prevalence of up to 20% and is increasing globally, is the most commonly diagnosed chronic inflammatory skin disorder. It is characterized by skin barrier disruption and immune dysregulation. It is estimated that 26.1 million people in the United States have AD, of which 6.6 million have moderate-to-severe disease. It is estimated that over 58% of adults with moderate-to-severe AD have disease which physicians consider to be inadequately controlled by approved therapeutic modalities, including topical anti-inflammatory agents and systemic agents.

    About CBP-201

    CBP-201 is a novel IL-4Rα monoclonal antibody that has shown a favorable safety and efficacy profile in a Phase 1b clinical trial in adult patients with moderate-to-severe AD. CBP-201 was shown to be well tolerated with no new safety signals compared to other approved IL-4Rα blockers, and no reported injection site reactions or conjunctivitis. The proportion of patients given CBP-201 150mg or 300 mg or placebo, weekly for 4 weeks, who achieved an Investigator Global Assessment score of clear or almost clear skin (IGA 0,1) was 50%, 42.9% and 12.5% respectively. Additionally, skin lesion improvements were rapid, as evidenced as early as one week after dosing and were correlated with a rapid reduction in pruritus intensity and frequency. This suggests the potential for a differentiated efficacy profile, with fast onset of action for CBP-201 compared with data from clinical trials of the current biologic standard of care therapy.

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases such as atopic dermatitis (AD) and asthma. Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1). Specifically, we are developing CBP-307 for two types of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD).

    With current headquarters in China, additional operations in the United States and Australia, and clinical development activities in those geographies as well as Europe, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology. For additional information about Connect Biopharma, please visit our website at 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 statements regarding the potential of CBP-201 to achieve a differentiated profile to address the unmet needs of patients with AD and the timing of the results of the Company's phase 2 clinical trial evaluating CBP-201 in adult patients with moderate-to-severe AD. 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 from those set forth in this release due to the risks and uncertainties inherent in the Connect Biopharma business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). 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.

    IR/PR Contacts:

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com

    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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  10. Deutsche Bank announced today its appointment as depositary bank for the Nasdaq-listed American Depositary Receipt program of Connect Biopharma Holdings Limited.

    Connect Biopharma Holdings Limited (NASDAQ:CNTB), is a global clinical-stage biopharmaceutical company developing therapies for the treatment of T cell- driven inflammatory diseases with a core expertise in the use of functional cellular assays with T cells to screen discovering potent product candidates against immune targets.*

    "We are pleased to be appointed as depositary bank for Connect Biopharma Holdings Limited's NASDAQ-listed Level III American Depositary Receipt program," said Daniel Clark, Global Head of Depositary Receipts at Deutsche Bank. "We look forward to providing…

    Deutsche Bank announced today its appointment as depositary bank for the Nasdaq-listed American Depositary Receipt program of Connect Biopharma Holdings Limited.

    Connect Biopharma Holdings Limited (NASDAQ:CNTB), is a global clinical-stage biopharmaceutical company developing therapies for the treatment of T cell- driven inflammatory diseases with a core expertise in the use of functional cellular assays with T cells to screen discovering potent product candidates against immune targets.*

    "We are pleased to be appointed as depositary bank for Connect Biopharma Holdings Limited's NASDAQ-listed Level III American Depositary Receipt program," said Daniel Clark, Global Head of Depositary Receipts at Deutsche Bank. "We look forward to providing dedicated client service and investor relations support to help drive the program's future success."

    In addition to specializing in administering cross-border equity structures such as New York Shares and American and Global Depositary Receipts, Deutsche Bank provides corporates, financial institutions, hedge funds and supranational agencies around the world with trustee, agency, escrow and related services.

    Deutsche Bank offers a very broad range of services for diverse products, from complex securitizations and project finance to syndicated loans, debt exchanges and restructurings.

    * This information was provided by Connect Biopharma Holdings Limited (March 2021).

    Depositary Receipt Information

    Country

    China (Cayman Islands incorporated)

    Custodian Bank

    Deutsche Bank AG, Hong Kong Branch

    Effective Date

    March 23, 2021

     

     

    Level III ADR

     

    CUSIP

    207523 101

    ISIN

    US2075231017

    Symbol

    CNTB

    Exchange

    NASDAQ

    Current Ratio

    1 ADS: 1 Class A ordinary share

    Eligibility

    DTC

     

     

     

     

     

    Depositary Receipt Contacts

    Head of Depositary Receipts

    New Business Development

    Daniel Clark

    William Ng

    Tel: +44 (0) 20 7541 6888

    Tel: +852 2203 7889

     

     

    www.adr.db.com

    Markets Distribution

    adr@db.com

    London

     

    Tel: +44 (0) 20 7547 6500

    gtb.db.com

    New York

     

    Tel: +1 212 250 9100

     

    Hong Kong

     

    Tel: +852 2203 7854

    Deutsche Bank provides commercial and investment banking, retail banking, transaction banking and asset and wealth management products and services to corporations, governments, institutional investors, small and medium-sized businesses, and private individuals. Deutsche Bank is Germany's leading bank, with a strong position in Europe and a significant presence in the Americas and Asia Pacific.

    The Depositary Receipts have been registered pursuant to the US Securities Act of 1933 (the "Act"). The investment or investment service which is the subject of this notice is not available to retail clients as defined by the UK Financial Conduct Authority. This notice has been approved and/or communicated by Deutsche Bank AG New York. The services described in this notice are provided by Deutsche Bank Trust Company Americas (Deutsche Bank) or by its subsidiaries and/or affiliates in accordance with appropriate local registration and regulation. Deutsche Bank is providing the attached notice strictly for information purposes and makes no claims or statement, nor does it warrant or in any way represent, as to the accuracy or completeness of the details contained herein or therein. This announcement appears as a matter of record only. Neither this announcement nor the information contained herein constitutes an offer or solicitation by Deutsche Bank or any other issuer or entity for the purchase or sale of any securities nor does it constitute a solicitation to any person in any jurisdiction where solicitation would be unlawful. No part of this notice may be copied or reproduced in any way without the prior written consent of Deutsche Bank. Past results are not an indication of future performance. Copyright© March 2021 Deutsche Bank AG. All rights reserved.

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  11. SAN DIEGO and TAICANG, China, March 23, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) (the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T-cell-driven research, today announced the closing of its initial public offering of 12,937,500 American Depositary Shares ("ADSs"), representing 12,937,500 ordinary shares of the Company, at a public offering price of US$17.00 per ADS.

    The number of ADSs issued at closing included the exercise in full of the underwriters' option to purchase 1,687,500 additional ADSs from the Company at the initial public offering price, less underwriting…

    SAN DIEGO and TAICANG, China, March 23, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) (the "Company"), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T-cell-driven research, today announced the closing of its initial public offering of 12,937,500 American Depositary Shares ("ADSs"), representing 12,937,500 ordinary shares of the Company, at a public offering price of US$17.00 per ADS.

    The number of ADSs issued at closing included the exercise in full of the underwriters' option to purchase 1,687,500 additional ADSs from the Company at the initial public offering price, less underwriting discounts and commissions. The gross proceeds from the offering were approximately US$219.9 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. Each ADS represents one ordinary share of the Company. The ADSs began trading on the Nasdaq Global Market on March 19, 2021 under the ticker symbol "CNTB".

    Jefferies LLC, SVB Leerink LLC, Piper Sandler & Co. and China International Capital Corporation Hong Kong Securities Limited acted as joint book-running managers for the offering.

    A registration statement relating to the securities sold in this offering was declared effective by the U.S. Securities and Exchange Commission on March 18, 2021. This offering was made only by means of a prospectus. A copy of the final prospectus may be obtained from (i) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-821-7388, or by email at Prospectus_Department@jefferies.com; (ii) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: 1-800-808-7525 ex. 6105 or email: syndicate@svbleerink.com; (iii) Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at 1-800-747-3924, or by e-mail at prospectus@psc.com; or (iv) China International Capital Corporation Hong Kong Securities Limited, Address: 29th Floor, One International Finance Centre, 1 Harbour View Street, Central, Hong Kong, by telephone at 852-2872-2000 or by email at ECM_Project_Kayak@cicc.com.cn.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Connect Biopharma Holdings Limited

    Connect Biopharma Holdings Limited is a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients living with chronic inflammatory diseases through the development of therapies derived from our T cell-driven research.

    Our lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα), which is a validated target for the treatment of several inflammatory diseases such as atopic dermatitis (AD) and asthma.

    Our second lead product candidate is CBP-307, a modulator of a T cell receptor known as sphingosine 1-phosphate receptor 1 (S1P1).

    IR/PR Contacts: 

    Lazar FINN Partners

    David Carey (IR)

    T: +1-(212) 867-1768

    david.carey@finnpartners.com



    Erich Sandoval (Media)

    T: +1-(917)-497-2867

    erich.sandoval@finnpartners.com

    Corporate Contacts:

    info@connectpharm.com



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