Starpharma Holdings Limited (ASX: SPL), has published its Appendix 4C – Quarterly Cashflow Report for the period ended on 31 December 2018. SPL’s cash balance as at 31 December 2018 stood at $44.4 million, with both net operating and investing cash outflows for the quarter standing at $5.3 million. The cash balance excludes the expected $4.0 million R&D tax incentive which is said to be received during the March quarter. SPL’s strong cash balance enables the Company to support international approvals and the launch of VivaGel BV in multiple markets in parallel with continuation to build its high-value DEP portfolio.
The key events which took place during the quarter are as follows:
SPL signed the US license for VivaGel BV with ITF Pharma, Inc, a specialty medicinal company which concentrates on the health of women. SPL and its partners, Mundipharma and Aspen, undertook advanced pre-launch activities for VivaGel BV including extensive sales training, promotional activities and product manufacture, in readiness for launch in multiple territories in 1H 2019. The US FDA finished its review work of the VivaGel BV NDA and advised that it needs confirmatory clinical data before approval. SPL is in the process of securing a meeting with the FDA to clarify what clinical data will be required and is working with expert FDA consultants to expedite the path to approval. Also, the VivaGel® condom obtained a final regulatory agreement in Japan. Starpharma’s partner in Japan, market-leader Okamoto, has already commenced launch preparations and expects to launch the VivaGel® condom in the first half of 2019. DEP® docetaxel and DEP® cabazitaxel trials continue to progress well with encouraging efficacy signals in both trials in a range of tumor types, including prostate and lung cancer. Both products continue to exhibit a notable lack of bone marrow toxicity and other common side effects. The concluding stages of preclinical task for the DEP® irinotecan phase 1 / 2 trial is finished, and trial groundworks are well advanced for trial to begin in the financial year of 2019. The DEP ® docetaxel and DEP® cabazitaxel showed noteworthy effectiveness and secure benefits over gemcitabine or Abraxane®, and when combined, in a human pancreatic cancer model. Other partnered and preclinical programs continue to progress, including AstraZeneca’s AZD0466, which is due to enter the clinic this year. Starpharma’s internal DEP® programs included initial testing of several DEP® radiopharmaceutical candidates which demonstrated significant tumor accumulation in both prostate and brain cancer models. A patent for SPL7013 SPL7013 ophthalmic drops for viral conjunctivitis was granted to SPL by the US Patent and Trademark Office. This follows the independent US market research which confirmed a high degree of interest from both ophthalmologists and primary care physicians.
Looking at SPL’s stock performance and the return it has posted over the last few months, the stock has generated a negative return of 23.78% during the past three months. The shares of SPL closed the day’s session at A$1.090 (30 January 2019) with no further changes. The company has 371.62 million shares outstanding with a market capitalization of circa $405.07 million. The stock opened at A$1.100 with its day low at A$1.055 and a day’s high at A$1.125. The 52-week high and low of the company are marked at A$1.670 and A$0.870 respectively.
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