OBI Pharma Inc (浩鼎) yesterday gained shareholders’ approval to issue new shares to fund its long-term development, clinical trial and diversification plans.
The biotech company received authorization to issue no more than 15 million new shares to raise between NT$3 billion and NT$4 billion (US$98.51 million and US$131.35 million) at its annual general meeting in Taipei.
In light of its depressed stock price, fundraising would take place over the next one or two years, the company said, adding that it is considering either a capital injection through a private placement or in conjunction with issuance of depositary receipts abroad.
The company said that while its cash balance of NT$4.2 billion is enough to sustain operations through 2020, additional funding would be required by then, when a number of projects are expected to progress to phase two clinical trials.
OBI Pharma shares yesterday dipped 0.32 percent to NT$157.50 in Taipei trading.
The stock was trading above NT$681 in 2016, before tumbling after phase two and three clinical trials showed no statistical significance in proving the effectiveness of its breast cancer drug OBI-222.
The company and its executives have since been embroiled in insider trading allegations, sending a shockwave through the nation’s biotechnology sector.
Following the setback, the company is set to begin enrolling patients for a redesigned phase three clinical trial for the drug in the US, president Amy Huang (黃秀美) said.
The redesigned clinical study expanded enrollment criteria, making it available to a larger number of patients who are in varying stages of treatment and disease progression, Huang said.
In particular, triple-negative breast cancer patients with a higher level of expression of Globo H, which the drug — renamed Adagloxad Simolenin — is designed to target and trigger an immune system response.
The enrollment process would take place over the next two years, followed by three years of primary endpoint study and another two years survival analysis, Huang said.
The company will continue to devote funds to diversify its development pipeline, chairman Michael Chang (張念慈) said.
It is collaborating with AP Biosciences (圓祥生技) on OBI-3424, a first-in-class DNA alkylating agent that targets cancers that overexpress the aldo-keto reductase 1C3 enzyme, which is part of efforts to explore new territories in immune checkpoint inhibitors and bi-specific antibodies, as well as liver cancer treatments, Chang said.
While the company has been vindicated after Taipei prosecutors in February dropped insider trading charges against former Academia Sinica president Wong Chi-huey (翁啟惠) and OBI Pharma executives, the judicial process has taken its toll on operations, Chang and Huang said.
Chang added that he is confident that he would receive a favorable court ruling on other charges in September.
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