zh-twzhen
zh-twzhen

NEWS

合一生技股份有限公司 / 2024 / (Supplementary Explanation) Announcement of the Company’s board of directors’ resolution on the change of the cash capital increase plan for 2020

(Supplementary Explanation) Announcement of the Company’s board of directors’ resolution on the change of the cash capital increase plan for 2020

2024-11-12

Published Date:2024-11-12

Original Link:https://www.onenessbio.com/en/news_detail328_1.htm

No 1 Date of announcement 2024/11/12 Time of announcement 18:58:59
Subject (Supplementary Explanation) Announcement of the Company’s board of directors’ resolution on the change of the cash capital increase plan for 2020
To which item it meets paragraph 16 Date of events 2024/11/11
Statement
  1. Date of the board of directors resolution for the change: 2024/11/11
  2. Effective registration date of the original plan: 2020/09/23
  3. Resolution date of additional issuance: None
  4. Major change Reason for the change: Our company plans to conduct a cash capital increase plan in fiscal year 2020 by issuing new shares to participate in the issuance of overseas depositary receipts, with an estimated fundraising amount of NT$8,550,000 thousand. The funds will be allocated for four new drug research and development expenditures: FB704A new drug NT$1,732,065 thousand, OB318 new drug NT$985,626 thousand, FB918 new drug NT$2,337,054 thousand, and ON101 new drug NT$3,495,255 thousand. As of November 2, 2020, the total amount of funds received was NT$5,584,651 thousand. Considering the current market conditions, the drug development timeline, and the impact of the COVID-19 pandemic, we plan to adjust the project amount from the estimated fundraising amount of NT$8,550,000 thousand to the actual fundraising amount of NT$5,584,651 thousand. Additionally, the research and development timelines for FB704A and OB318 will be extended, while the development of FB918 and the phase III clinical trial for ON101 in the US will be terminated. The unused funds amounting to NT$1,751,116 thousand will be fully reallocated to improve working capital.
  5. Content of each and every successive previously changed plan for raising of funds before and after change:
    Original Capital Utilization Plan：

    Item Scheduled Completion Date Total Required Funds
    (thousand NT dollars)
    FB704A new drug 2024 Q4 1,732,065
    OB318 new drug 2024 Q4 985,626
    FB918 new drug 2025 Q4 2,337,054
    ON101 new drug 2024 Q4 3,495,255
    Total   8,550,000

    Revised Capital Utilization Plan:

    Item Scheduled Completion Date Total Required Funds
    (thousand NT dollars)
    FB704A new drug 2028 Q4 1,732,065
    OB318 new drug 2028 Q4 985,626
    FB918 new drug 2024 Q3 52,633
    ON101 new drug 2024 Q3 1,063,211
    Working Capital Supplement 2024 Q4 1,751,116
    Total   5,584,651

  6. Projected timetable for execution: 2028 Q4
  7. Projected completion date: 2028 Q4
  8. Projected possible benefits:
    1. (1) After the changes to the FB704A new drug plan, it is expected that the Phase IIb clinical trial will be completed in Q4 of 2028, allowing for licensing revenues to be recognized totaling NT$3,000,000 thousand. For the OB318 new drug plan, it is expected that the Phase IIa clinical trial will be completed in Q4 of 2028, allowing for licensing revenues totaling NT$1,350,000 thousand. The total licensing revenue is expected to be NT$4,350,000 thousand.
    2. (2) Improving Working Capital: It is planned to use the raised funds of NT$1,751,116 thousand to improve working capital, supporting daily operational needs, increasing the flexibility of the company’s capital allocationto maintain industry competitiveness.
  9. Difference from original projected benefits:
    1. (1)The development timeline for the new drugs FB704A and OB318 has been extended due to external environmental factors. However, the expected royalty benefits remain unchanged, so there is no difference in the outcome.
    2. (2)After the changes to the company’s plan, although the development plans for the FB918 and ON101 new drugs have been halted, the research efforts and processes already invested in these projects still provide certain benefits to the company. Additionally, reallocating funds to improve working capital will strengthen the financial structure, reduceoperational risks, and improve the company’s competitiveness and ability to respond to changes in risk factors.
  10. Effect of the current change on shareholder equity: The company has made more appropriate adjustments to its funding plan based on changes in the external environment and actual business needs, in alignment with its business strategy and expected benefits. These adjustments are expected to positively contribute to the company’s operations, development, and use of funds. They will also enhance the company’s ability to respond to future changes in the business environment, improve the efficiency of fund utilization, and should not have any adverse impact on shareholder equity.
  11. Abstract of the original lead underwriter’s appraisal opinion: Due to the impact of the COVID-19 pandemic, the clinical trails progress for the FB704A and OB318 new drugs has been delayed, and they are currently undergoing Phase IIa and Phase I clinical trials, respectively. Additionally, after analyzing the market potential of the FB918 new drug and comparing its characteristics and mechanisms of action with currently known drugs and those in clinical development, it has been determined that there are no significant advantages, leading to a decision to pause its development. Furthermore, the ON101 new drug has also been affected because the company’s medical product, Bonvadis wound ointment, received FDA approval for acute and chronic wound indications in August 2022 and May 2024. These indications include partial-thickness wounds (suitable for diabetic foot ulcers grade 1, venous ulcers, and pressure ulcers grades 1-2), postoperative sutured wounds, and burns (first-degree and superficial second-degree). Considering the overall economic benefits, it has been decided not to proceed with the Phase III clinical trial for ON101 in US. In addition to the new drug development projects under the 2020 fiscal year fundraising plan, the company still needs to cover personnel costs and various operational expenses to maintain normal operations. To ensure the efficiency of capital utilization, it is proposed to allocate all remaining funds raised for the FB918 and ON101 new drug plans, which have not yet been used, to improve working capital. This will not only improve the company’s ability to respond to industry risks but also help reduce operational and financial risks.
  12. Any other matters that need to be specified:
    1. (1)Explanation of Projected possible benefits:The expected benefits are based on international case studies and relevant research reports, comparing the projected outcomes of licensing agreements for new drugs in clinical trials for the same indications. However, the actual results will depend on the execution and specific circumstances of the project.