Recent share-price trend of Cellid (Source: KG Zeroin MP DOCTOR)
◇Cellid Jumps 27% on COVID Theme, Seeks Phase 3 Restart
According to KG Zeroin's MP DOCTOR, Cellid closed at 2,740 won, up 27.15%, after rising as high as 2,800 won intraday. The stock has gained 55.9% in six trading sessions from its Aug. 21 close of 1,758 won, amid renewed concerns over COVID-19.
Cellid has been developing AdCLD-CoV19-1 OMI, a COVID-19 vaccine based on its adenovirus vector platform. However, a global Phase 3 trial comparing the vaccine with Pfizer's Comirnaty 2 Inj. failed to demonstrate non-inferiority on the primary immunogenicity endpoint.
Results released in June showed an adjusted geometric mean titer ratio of 0.42, with the lower bound of the 95% confidence interval at 0.38, below the non-inferiority threshold of 0.67. The seroresponse rate was 17.12% in the Cellid group versus 42.64% in the control group.
Safety results were more favorable. Adverse events occurred in 34.38% of the Cellid group versus 69.96% in the active-control group, while no serious adverse drug reactions were reported.
"It is true that the Phase 3 results fell short of expectations, but the full dataset showed favorable safety results compared with the control vaccine," Cellid CEO Kang Chang-yul told Edaily.
Cellid is considering amending its investigational new drug application after supplementing efficacy data. Kang said the company is preparing as quickly as possible but added that discussions with the Ministry of Food and Drug Safety are still required, leaving the timeline uncertain.
Recent share-price trend of Onconic Therapeutics (Source: KG Zeroin MP DOCTOR)
◇Onconic Jumps 22% on U.S. Patent Allowance for Nesuparib
Onconic closed at 18,030 won, up 22.07%, after announcing a U.S. patent allowance covering a novel crystalline form and manufacturing method for anticancer candidate Nesuparib.
Nesuparib is a dual-target synthetic-lethality drug candidate that inhibits tankyrase and PARP. Phase 2 trials are underway in pancreatic, ovarian, endometrial and gastric cancers.
The new patent, expected to remain in force through May 2042, adds an additional layer of protection beyond the existing composition-of-matter patent scheduled to expire in 2036.
"Onconic is not simply presenting the possibility of developing a new drug. We have actual experience taking a drug through regulatory approval," an Onconic official told Edaily.
The official added that the company's follow-on oncology pipeline is progressing smoothly and said its technology and commercialization capabilities are not yet fully reflected in its market valuation.
VUNO share price on Aug. 31 (Source: KG Zeroin MP DOCTOR)
◇VUNO Plunges on 31.4 Billion Won Offering as CB Burden Persists
VUNO closed at 5,590 won, down 24.46%, after announcing a 31.4 billion won rights offering following the Aug. 28 market close. Trading volume surged to 256,284 shares, more than 21 times the previous session.
The company plans to issue 6.3 million new shares at a preliminary price of 4,980 won. The new shares amount to about 45% of VUNO's existing 14 million shares, raising significant dilution concerns.
Of the planned proceeds, 20 billion won will be used to repay debt, 10.624 billion won for working capital and 750 million won for other purposes. About 64% of the proceeds will therefore go toward debt repayment rather than growth investment.
The preliminary issue price is 32.7% below VUNO's Aug. 28 close of 7,400 won and may be adjusted depending on future share-price movements. If the final issue price falls, actual proceeds could decline, potentially leaving less capital available for operations and growth after repayment of the third perpetual convertible bond, or CB.
The offering will not fully resolve VUNO's CB burden. The company will still have fourth and fifth perpetual CBs outstanding, each worth 10 billion won, with interest payments set to begin at the end of next year.
"There is currently no fixed repayment plan, and we intend to respond depending on market conditions," a VUNO official told Edaily.
VUNO is looking to a new health technology assessment expected in the fourth quarter as a potential growth catalyst. The company will hold a shareholder meeting on Sept. 4 to explain the background behind the rights offering.
