On 22 January 2019, AdAlta Limited (ASX:1AD) has released a manufacturing update for AD-214. Based on current timelines, manufacturing remains on track which will move AdAlta’s lead program for the treatment of Idiopathic Pulmonary Fibrosis (IPF) into Phase 1 human clinical trials in January 2020.
AdAlta Limited is a biotech company which develops protein therapeutics, also known as i-bodies. The company also focuses on further development of the i-body platform.
During the period the company has posted Initial results from the AD-214 cell-line development and this development was supported by Selexis. The company has also mentioned that manufacturing yields were in line with assumptions at just more than 1g/L and they have also mentioned that since the October announcement, the further yield improvements have been made.
The company has started expression and purification optimization activities at KBI Biopharma. Both Selexis and KBI are key manufacturing partners ( as announced in June 2018 quarter ) who are working together in an integrated manner so that they can develop a process for manufacturing AD-214. In June 2019, the company will receive the materials for its four-week non-human primate toxicology study, and at the end of 2019, the company will receive materials for the first-in-man clinical trial.
Several non-human primate studies are in the process, through these studies the company will get valuable dosing and safety information that will be informed at the AD-214 four-week toxicology study which is going to commence in July 2019. In parallel with the development of a manufacturing process for AD-214, the company also focuses on the competition of these non-human primate studies which indicates that the company is ready to commence its first-in-man clinical trial in January 2020.
In October, AdAlta’s CEO Mr. Sam Cobb met with shareholders in major capital cities around Australia and there he provided an update on the manufacturing process for AD-214
Financial update: - In October, the company received an R&D tax incentive refund of A$2.02 million which is in line with forecast, (over the prior year which was $1.78 million). As of 31 December 2018, the Company’s financial position was ~$5.36 million. Cash outflows for the period were ~$0.21 million, down from the previous quarter with the receipt of the R&D tax refund and expenses lower than expectations. The Company anticipates total cash outflows over the March quarter to be $3.27 million. The company is planning to tap additional fund sources for the activities which are required to progress AD-214 to the clinic.
Stock performance: The shares of AdAlta Ltd is trading flat at A$0.240 (23 January 2019). The market capitalization of the company stands at circa $28.23 Million with 117.6 million outstanding shares. In the time span of the previous six and three months, the stock delivered the negative return of 20% and 14.29%, respectively. During the last one month, 1AD delivered the return of 4.35%.
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