BRIDGING SCIENCE AND PATIENTS
This information was prepared by Bridge Biotherapeutics, Inc. (hereinafter ‘the Company’), with an aim to provide information about the Company and its plans to stakeholders. The accuracy of the ‘forward-looking statements’ included in this page has not been independently verified. The forward-looking statements include projections and outlook of the Company concerning its business status and financial results, and include but not limited to words such as ‘expectation’, ‘forecast’, ‘plan’, ‘anticipation’ or ‘(E)’. These forward-looking statements are subject to changes in business environment and involve inherent risks and uncertainties. We caution you that a number of important factors may cause actual results to differ materially from those contained in any forward-looking statements. Furthermore, any future expectations are based on current business environment and the Company’s management direction as of the date of this information. The future projection may differ or change due to changes in business environment or due to strategic changes by the Company. The contents in this information may change without any prior notification. None of the Company nor its respective officers assume legal responsibility for any damage or loss that may have occurred from the use of this information, including errors and other mistakes that may be included in this information. This information does not constitute or form a part of an offer or solicitation to purchase or subscribe for securities for sale, and any information may not be used as a basis for related contracts, subscriptions or investment decisions.
What is the current clinical development status of BBT-401? (As of July 2020)
We have completed the patient recruitment process for the 1st cohort of our Phase 2a trial (total 16 persons: 12 persons in the treatment group, 4 persons in the control group). Due to the COVID-19 pandemic, patient participants are experiencing difficulties visiting clinical trial sites, however, we are actively seeking out strategies to minimize any impacts relating to the progress of our clinical trial and the verification of our clinical trial results. We are currently preparing to conduct a multinational clinical trial in the US and several European nations and we expect to begin the patient enrollment process for our 2nd cohort at the end of 2020 or early 2021.
In order to proceed with the Phase 1 clinical trial, we submitted our investigational new drug (IND) application to the Chinese National Medical Products Administration (NMPA) in Sept., 2019 and received clearance in Dec., 2019. While we are experiencing mild delays due to the COVID-19 pandemic, we are proactively preparing to initiate the clinical trial in various regions inclusive of Beijing.
In order to initiate our Phase 2a clinical trial, we have submitted our investigational new drug (IND) application to the Ministry of Food and Drug Safety (MFDS). The IND application is currently under review by the MFDS.
What is the current clinical development status of BBT-176? (As of April 2021)
In April 2021, we initiated the Phase 1/2 clinical trial assessing safety, tolerability, and anti-tumor activity of BBT-176 in non-small cell lung cancer (NSCLC) patients who acquired osimertinib-resistant EGFR triple mutations.
The clinical trial is expected to enroll approximately 90 participants separated into two parts: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). In the first part of the study, which has been initiated in the Republic of Korea, the RP2D (Recommended Phase 2 Dose) will be identified based on the evaluation of drug safety and tolerability in the treatment group. The subsequent part of the study will be conducted both in the U.S. and Korea this year.
What is the current clinical development status of BBT-877? (As of March 2021)
We remain committed to developing BBT-877, our autotaxin inhibitor (P1 completed), hoping to bring new therapeutics options to patients who are eagerly seeking better options fo fight IPF.
Bridge Biotherapeutics submitted FDA Type C meeting to discuss about the safety concerns raised and map out the development plan path forward.
Based on scientific data, we believe that BBT-877 could provide a treatment option with better efficacy and safety profile to patients in urgent need.
What is the current clinical development status of BBT-212? (As of July 2020)
Bridge Biotherapeutics and Konkuk University are jointly conducting early stage translational research in order to validate the efficacy of the drug candidate. We aim to enter into the pre-clinical development stage after completing the requisite preparations.
When will we be licensing-in our next new drug candidate? (As of July 2020)
We are actively reviewing various new drug candidates that have been discovered by both domestic and international academia and research institutes. Candidates which show a high potential to be developed into an innovative treatment will undergo a vigorous commercial and scientific review before we determine whether we will license-in the candidate. Following the in-licensing of our retinal disease treatment from Konkuk University, we have been reviewing additional drug candidates that we may license-in in the future.
What are Bridge Biotherapeutic’s development priorities in terms of disease areas? (As of July 2020)
We seek to expand our development pipeline in areas with high unmet medical needs. Furthermore, we will continue to focus on our core strengths which include autoimmune diseases, inflammatory diseases and oncology, in which we have gained significant expertise through our substantial global clinical development experiences.
What is the current status of our collaboration with Atomwise? (As of July 2020)
Following our research collaboration agreement in Mar., 2020, we have progressed from the 1st potential drug candidate to the 2nd potential drug candidate. Dependent on future developments, we may expand our collaboration to a maximum of 13 potential drug candidates and utilize our collaboration as our new drug discovery engine.
Do we have any plans to expand our R&D team? (As of July 2020)
In order to reinforce our internal drug discovery capacity, we have recently expanded our research personnel, and will continue to strengthen our internal research team. We also seek to reinforce our Clinical Trial Team and our Chemistry, Manufacturing and Control (CMC) Team through the addition of experienced specialists. Lastly, our long-term plan is to expand our research team in order to bolster our late-stage clinical development capacity.
Who are our board members? (As of March 2021)
Our board members include Deborah DongHyun Chee, a clinical development professional, Stephen Seoungyeob Paek, a corporate governance specialist, Seunghoon Lee, an international finance specialist and Choo Yul Yoo, accounting/finance specialist. Our board members work diligently to strengthen our capacity in each respective field while providing us with a robust network of industry professionals.
Are there any updates relating to our overhang issue? (As of end-1Q, 2021)
As of the end of the 1st quarter (2021), our overhang has declined to approximately 5% of total shares outstanding excluding investors with public disclosure requirements. We will update our investors when any new information is available.
Does Bridge Biotherapeutics have any shareholder friendly policy plans? (As of July 2020)
Despite having reviewed various shareholder friendly policies, we are unable to confirm any details at this point in time. Our senior management and board members are continuing to review potential shareholder friendly policies that will compliment our long-term corporate strategy. We will inform our investors accordingly, once we have finalized our shareholder friendly policies.
What is our guideline for IR conferences and meeting? (As of July 2020)
We will hold quarterly IR video conference calls after we have publicly disclosed our financial statement. The earliest quarterly IR video conference call is scheduled after the 15th of August and we will provide further details via public disclosure and our company’s official communication channels.
What are our disclosure requirements?
As a KOSDAQ listed public company, we abide by the disclosure rules and regulations issued by the Financial Supervisory Service (FSS) and the Financial Services Commission (FSC). Furthermore, with the exception of trade secrets (inclusive of but not limited to information pertaining to our collaborations with our various partners), we will continue to proactively provide transparent and timely information to our investors.