Starpharma (ASX:SPL) launches antiviral nasal spray in Europe

May 6th, 2021

The Market Herald reported on Starpharma's launch of VIRALEZE™  in Europe. Read the full article here.

  • Starpharma’s (SPL) antiviral nasal spray is now available for purchase by consumers in Europe via the company’s online store
  • VIRALEZE is a broad spectrum antiviral nasal spray, which studies have shown can inactivate more than 99.9 per cent of coronavirus pathogens within one minute
  • The product is already available online in the U.K. and through Lloyds Pharmacy’s 1400 stores, with the company now pursuing avenues to provide rapid access for VIRALEZE in India
  • Starpharma shares are up 3.93 per cent, trading at $1.85

 

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VIRALEZE™ launches in Europe

May 6th, 2021

Starpharma today announced that VIRALEZE antiviral nasal spray is now available for purchase by consumers in Europe via Starpharma’s www.viraleze.co webstore.

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Australian company develops a $27 anti-viral nasal spray that 'deactivates' Covid - and it's being used right across the UK

May 4th, 2021

Eliza McPhee for Daily Mail Australia reported: An Australian biotech company has joined the fight against coronavirus by launching an anti-viral nasal spray that's already available in the UK. Read the article here

  • Biotech company Starpharma has launched anti-viral nasal spray in the UK
  • It acts as a barrier to coronavirus, trapping it in the nose and inactivating virus
  • Spray best used once every six hours for up to 30 days, CEO Jackie Fairley says
  • Melbourne-based company says it has plans to launch product soon in Australia 
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VIRALEZE™ on 7NEWS Australia

May 1st, 2021

VIRALEZE™ was featured on 7NEWS Australia in an interview with Starpharma CEO Dr Jackie Fairley. The antiviral nasal spray is now available online and instore at LloydsPharmacy in the UK with EU launch to follow in the coming weeks. Watch the playback on 7plus (~32.28 min.) or YouTube below.

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Starpharma (ASX:SPL) spends March quarter developing VIRALEZE

Apr 28th, 2021

Starpharma featured in The Market Herald following the announcement of Starpharma's Quarterly Cashflow and Activities Report. Read more here

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Shareholder Newsletter

Apr 28th, 2021

The Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) Shareholder Update – April 2021 is now available to view online.

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Quarterly Cashflow and Activities Report

Apr 27th, 2021

Melbourne, Australia; 27 April 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2021.

Starpharma’s cash balance as at 31 March 2021 was $64.3 million.

Net operating cash outflows for the quarter were $5.8 million, including significant investment in DEP®/VIRALEZE™ clinical trials and product manufacture of VIRALEZE™, and launch-related items, e.g., EU taxation costs (expected to be refundable). Expenditure during the quarter also includes costs associated with VIRALEZE™ registration, further antiviral testing and the small safety study undertaken to support commercialisation activities, as well as expenditure on Starpharma’s three phase 2 clinical programs – for DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan. 

Key recent activities and events:

  • Starpharma announced a new Research Agreement with leading global pharma company Merck utilising Starpharma’s proprietary DEP® technology for dendrimer-based ADCs. Starpharma’s DEP® partner, Merck, is ranked 4th globally by total sales revenue and is a recognised leader in oncology.
  • AstraZeneca advised a significant expansion of its clinical program for DEP® AZD0466, to include a multi-centre global phase 1 study with a focus on haematological tumours. The clinical expansion facilitates patient recruitment and is aimed at rapid development and approval of AZD0466.
  • On 25 March Starpharma signed an exclusive commercial arrangement for VIRALEZE™ with LloydsPharmacy/McKesson UK, one of the largest pharmacy groups in the UK with around 1,400 LloydsPharmacy stores across the UK and servicing a further 14,000 independent UK pharmacies.
  • On 29 March, VIRALEZE™ was launched in the UK by LloydsPharmacy, initially online and in its first week was the fastest selling product on record on LloydsPharmacy.com. Whilst it is not expected that this rate of sales will necessarily be maintained, both Starpharma and LloydsPharmacy have been very pleased with the launch of the product. VIRALEZE™ has been well received by UK consumers, and the product is now also available at LloydsPharmacy outlets in-store.
  • To date, Starpharma has invoiced LloydsPharmacy $1.2 million, for the launch supply of VIRALEZE™ in the UK, with further orders to be filled between now and the end of FY21.
  • Starpharma has been progressing arrangements to facilitate the launch of VIRALEZE™ in other parts of Europe in the coming weeks via viraleze.co, as well as commercial discussions with pharmacy groups.
  • As outbreaks of COVID-19 continue around the world, commercial interest in VIRALEZE™ remains strong and discussions for distribution of the product in a number of markets actively continue in parallel. Starpharma is also engaged in discussions with organisations, including various sporting teams which have expressed interest in the product.
  • Starpharma is leveraging the European registration of VIRALEZE™ to expedite further marketing approvals for the product as soon as practicable in other countries, including Australia.
  • Dosing was completed in the VIRALEZE™ double-blinded, placebo-controlled safety study, which was undertaken to support commercialisation activities. The study involved 40 healthy volunteers, using VIRALEZE™ or placebo 4 times a day for 14 consecutive days. All participants have now completed the study. Whilst the data is not yet unblinded, both VIRALEZE™ and the placebo nasal spray were extremely well tolerated by all participants.
  • Further antiviral testing of SPL7013 (VIRALEZE™ active) at the Scripps Research Institute has confirmed it is active in two additional pandemic coronaviruses - severe acute respiratory syndrome coronavirus (SARS-CoV) or “SARS” and Middle East respiratory syndrome coronavirus (MERS‑CoV) or “MERS”. SPL7013’s broad-spectrum antiviral activity is a compelling feature for the role of VIRALEZE™ today and further testing is underway in multiple COVID strains.
  • DEP® irinotecan phase 2 trial continues to progress well, with more than 40 patients now recruited. Encouraging efficacy signals observed include prolonged stable disease, impressive tumour shrinkage and reductions in tumour marker levels for a number of tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. A patient with heavily pre-treated metastatic ovarian cancer experienced a 98% reduction of tumour marker (CA-125) following 7 cycles of DEP® irinotecan, and follow up scans showed a complete disappearance of her ovarian target tumour.
  • DEP® docetaxel clinical trials continue to progress well, with more than 40 patients now recruited and encouraging efficacy signals observed, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal, and gastric cancer. These impressive tumour responses include stable disease for up to 40 weeks and significant tumour shrinkage in a heavily pre-treated oesophageal cancer patient, maintained for more than 28 weeks. In addition to the monotherapy of DEP® docetaxel, Starpharma is also recruiting into a study combining DEP® docetaxel with gemcitabine. This study follows compelling data for this combination in pre-clinical human pancreatic cancer models.
  • DEP® cabazitaxel phase 2 trial continues to progress well, with more than 35 patients now recruited. Encouraging efficacy signals have been observed, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g., PSA), in cancers including prostate, ovarian, lung, gastro-oesophageal, head and neck and other cancers. These impressive tumour responses include significant tumour shrinkage including in prostate and ovarian cancer, in patients who have failed multiple other lines of cancer treatment.
  • Starpharma’s second radiopharmaceutical candidate, DEP® HER2-lutetium outperformed in human breast cancer model - achieving complete tumour regression, outperforming Herceptin® (trastuzumab) labelled with lutetium, in a human breast cancer model (BT474).
  • Further DEP® candidates are being progressed toward the clinic, including DEP®
  • Starpharma is engaged in active discussions with further partners in relation to DEP® The Company’s disclosed/undisclosed partnered programs continued to progress, including with AstraZeneca, Merck and Chase Sun. Following the Merck ADC partnership, Starpharma has also initiated a number of new ADC discussions.
  • Mundipharma has continued its rollout of VivaGel® BV with the launch of Betadine™ BV Gel in South Africa in March 2021. The Starpharma and Mundipharma teams continue to work together on expanding the breadth of regulatory submissions for VivaGel® BV, which has now been approved in more than 45 countries. Further regulatory submissions are underway to support additional launches of VivaGel® BV in Mundipharma’s territories.

Dr Jackie Fairley, Starpharma CEO, commented: “It has been an important quarter for Starpharma, with multiple value-adding milestones achieved in the DEP® portfolio, in addition to the commercialisation and launch of VIRALEZE™. Starpharma signed with leading global pharma company Merck, in the cutting-edge area of ADCs. We were also delighted that AstraZeneca is significantly expanding its clinical program for AZD0466 globally to support rapid development and approval of this product”.

Dr Fairley added, “Alongside these partnered DEP® programs, we also progressed our internal DEP® assets, including our three clinical stage assets which continued to recruit further patients and report impressive tumour responses, in heavily pre-treated patients who have limited options”.

“Starpharma was excited to launch VIRALEZE™ in the UK in March, ahead of our original schedule. We were pleased to partner with Lloyds/McKesson to bring this important product to consumers in the UK. We are rapidly advancing the launch of VIRALEZE™ in other parts of Europe and look forward to pursuing registrations in further countries and regions”.  

The closing cash balance as at 31 March 2021 was $64.3 million. Net operating cash outflows of $5.8 million for the quarter includes significant investment in R&D ($4.3 million) and product manufacturing and operating expenses, this reflects investment in multiple phase 2 DEP® clinical programs and manufacture of VIRALEZE™. Receipts from customers and grants in the quarter totalled $0.6 million. Staffing levels remained stable with quarterly staff costs of $1.6 million, including non-executive and executive directors’ fees of $233,000.

Download ASX Announcement: Quarterly Cashflow and Activity Report (pdf, 428kb)

 

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GlaxoSmithKline hoping to deliver Australia’s next COVID treatment

Apr 16th, 2021

Starpharma featured in The Sydney Morning Herald's daily COVID-19 update, as reported by Emma Koehn: ASX-listed companies have pivoted swiftly towards virus treatments and preventative in the past year, including Melbourne-based Starpharma which successfully brought a nasal spray to market in the UK last month. Read more here

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Aussie virus killer not to be sneezed at

Apr 11th, 2021

The Australian interviewed Dr Jackie Fairley, Starpharma CEO, about the recent launch of Viraleze in the UK. "As the nation hyperventilates over a delay in the vaccine rollout, Starpharma is rolling out a new line of defence against the coronavirus in global markets." Read more here. (Behind paywall)

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LloydsPharmacy launches nasal spray designed to fight coronavirus

Mar 30th, 2021

The Grocer reported on the launch of VIRALEZE in LloydsPharmacy across the UK. It launches online this week, ahead of an in-store rollout from April. Read more here.

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Covid antiviral nasal spray available from Lloyds

Mar 30th, 2021

Pharmacy Magazine UK reported on the launch of VIRALEZE in the UK. A novel nasal spray available exclusively from LloydsPharmacy. The UK will be the first country to launch this product. Read more here.

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Lloyds Pharmacy offering first-ever Covid nasal spray Viraleze that 'blocks 99.9% of germs'

Mar 30th, 2021

CambridgeshireLive featured news of the VIRALEZE launch in the UK. A groundbreaking Covid nasal spray called Viraleze is now available to buy online. Lloyds Pharmacy is rolling out the UK's first-ever nasal spray specifically designed to fight coronavirus. Read more here

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VIRALEZE™ now launched by LloydsPharmacy in the UK

Mar 30th, 2021

Starpharma today confirms that Starpharma’s VIRALEZE™ antiviral nasal spray has launched in the UK by LloydsPharmacy, as announced on 25 March 2021.

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Sky News reports on launch of VIRALEZE™

Mar 29th, 2021

Sky News interviewed Starpharma CEO Dr Jackie Fairley about the UK launch of VIRALEZE™ at LloydsPharmacy. Dr George Kinghorn, Infectious Disease Adviser and former Clinical Director of the Sheffield Teaching Hospitals NHS Foundation Trust was also interviewed for further commentary on VIRALEZE™.

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Starpharma to launch anti-COVID nasal spray with major UK pharmacy chain

Mar 25th, 2021

Business News Australia reported VIRALEZE will be stocked by LloydsPharmacy in the UK. It will first be made available at LloydPharmacy's online store and is expected to be instore in April. Read more here.

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Aussie biotech Starpharma signs deal to sell COVID nose spray in Britain

Mar 25th, 2021

The Age reported Australian biotech Starpharma is taking its COVID-fighting antiviral nasal spray to the world, signing a deal with UK chemist chain LloydsPharmacy to sell the product in Britain as the country emerges from lockdown. Read more here

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VIRALEZE™ to be launched with LloydsPharmacy in the UK

Mar 25th, 2021

Starpharma today announced it has signed a sales and distribution agreement for VIRALEZE™ antiviral nasal spray with LloydsPharmacy and the McKesson group in the UK. LloydsPharmacy/McKesson is one of the largest pharmacy groups in the UK and is also a major wholesaler in the UK.

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Starpharma (ASX:SPL) reports DEP HER2-lutetium shows potent anticancer effect

Mar 16th, 2021

Finance News Network reported that Starpharma's second radiopharmaceutical candidate, DEP HER2-lutetium, achieved potent and durable anticancer activity, with complete tumour regression, outperforming Herceptin labelled with lutetium, in a breast cancer model. Read more here

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Starpharma (ASX:SPL) shares rise on breast cancer development

Mar 16th, 2021

The Market Herald reported that Starpharma's second radiopharmaceutical candidate, DEP HER2-lutetium, had achieved anti-cancer activity in breast cancer, and that the drug outperformed Herceptin, a treatment for a type of breast cancer called HER2 positive. Read more here

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DEP® HER2-lutetium outperforms in human breast cancer model

Mar 16th, 2021

Starpharma today announced that its second radiopharmaceutical candidate, DEP® HER2-lutetium, achieved potent and durable anticancer activity, with complete tumour regression, outperforming Herceptin® (trastuzumab) labelled with lutetium, in a human breast cancer model (BT474).

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SPL7013 active against other pandemic coronaviruses

Mar 3rd, 2021

Starpharma today announces new data from The Scripps Research Institute in the US and other specialist laboratories on the activity of SPL7013 against important respiratory viruses, including those responsible for past pandemics. This new data further confirms the broad spectrum antiviral properties of SPL7013 (VIRALEZE™ active), with SPL7013 blocking the spike protein of two additional important pandemic causing coronaviruses, SARS-CoV and MERS‑CoV.

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Starpharma Up With News, Down With None; Timing Entry Makes Sense

Feb 25th, 2021

Seeking Alpha, a financial market portal featured an update Starpharma, including the European registration of its VIRALEZE™ antiviral nasal spray. To read the full article click here.

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Interim Report and Half-Year Financial Results

Feb 25th, 2021

Starpharma today released its interim report and financial results for the half-year ended 31 December 2020.

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Channel 7 News reports Starpharma's VIRALEZE has been registered in the UK/Europe

Feb 23rd, 2021

Channel 7 News (Melbourne) reports Starpharma's VIRALEZE™ has been registered in the UK/Europe. Watch here

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VIRALEZE™ antiviral nasal spray registered in Europe

Feb 23rd, 2021

Starpharma announced today it had received confirmation that the VIRALEZE™ antiviral nasal spray has been successfully registered for sale in Europe, including in the UK.

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Starpharma signs research agreement with MSD

Feb 12th, 2021

The Market Herald reported that Starpharma signed a Research Agreement with Merck & Co., Inc., Kenilworth NJ USA for dendrimer-based Antibody Drug Conjugates (ADCs) utilising Starpharma’s proprietary DEP® technology. Read more here

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Starpharma signs DEP® ADC Research Agreement with MSD

Feb 12th, 2021

Starpharma today announced that is has signed a Research Agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth NJ USA. Under the agreement, MSD will conduct a preclinical research evaluation of dendrimer based Antibody Drug Conjugates (ADCs) utilising Starpharma’s proprietary DEP® technology.

 

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Ausbiz interviews Starpharma CEO Dr Jackie Fairley

Feb 10th, 2021

Finance and market news website AusBiz interviewed Starpharma CEO Dr Jackie Fairley to discuss the global expansion of AstraZeneca’s clinical trial for AZD0466 and their multi-product DEP® licence with Starpharma. She also spoke about the upcoming launch of VIRALEZE in Europe. Watch the interview here.

 

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AZD0466 clinical DEP® program global expansion

Feb 9th, 2021

Starpharma today announced that it had been advised by AstraZeneca of its intention to expand the clinical program for AZD0466 to include a multi-centre global Phase 1 study. The study will recruit patients with acute leukaemias.

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Aussie condom antiviral recruited for Covid-19 fight

Feb 4th, 2021

The Australian interviewed Starpharma CEO Dr Jackie Fairley regarding Starpharma’s plans for the European launch of VIRALEZE™ antiviral nasal spray. Read article here.

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Australian-developed COVID nasal spray set to land in Europe

Feb 4th, 2021

Biotech Dispatch reported on Starpharma's launch plans for VIRALEZE™ in Europe. Read the full article here.

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Channel 7 evening news features Starpharma's VIRALEZE

Feb 3rd, 2021

Watch Laurel Irving Channel 7 News (Melbourne) interview Dr Jackie Fairley, CEO of Starpharma about VIRALEZE™ and the need for other COVID-19 preventative tools alongside vaccines. 

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Starpharma prepares to launch COVID-killing nasal spray

Feb 2nd, 2021

Alan Kohler spoke with Dr Jackie Fairley, CEO of Starpharma about the launch of its VIRALEZE™ antiviral nasal spray, for the Eureka Report. Listen to the interview here.

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Quarterly Cashflow and Activity Report

Jan 29th, 2021

Starpharma released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2020.

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Leading broker names the ASX healthcare shares to buy in 2021

Jan 9th, 2021

The Motley Fool reported that Starpharma has been named by analysts at Bell Potter "one of ASX shares from several industries that they believe are best placed to have a strong 2021".

To read the full article, click here

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VIRALEZE COVID-19 nasal spray study to commence in January

Dec 22nd, 2020

Starpharma today announced that it has received all necessary approvals to commence its clinical study for VIRALEZE™. The study will commence enrolment of healthy volunteers in Perth in early January 2021 and is expected to be completed in Q1 2021. This study is being undertaken to support commercialisation activities for VIRALEZE™, and is not a requirement to achieve EU product registration.  

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VIRALEZE™ COVID-19 nasal spray to be ready for market Q1CY21

Dec 10th, 2020

Starpharma today announced significant commercial and regulatory progress has been made for VIRALEZE™ nasal spray with the EU regulatory dossier more than 90% complete and VIRALEZE™ now on track to be registered, and ready for market in Q1 CY2021. This timing is earlier than previously announced.

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Starpharma Viraleze: COVID-19 Nasal Spray Development

Nov 20th, 2020

Seeking Alpha, a financial market portal featured a piece on Starpharma’s latest update on its VIRALEZE™ COVID-19 nasal spray. The article noted the potential of the spray and Starpharma’s latest regulatory developments on this front. To read the full article click here.

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AGM Chairman address and CEO presentation

Nov 20th, 2020

Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting (AGM) of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 11am (Melbourne time) today.

 

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SPL7013 shows potent antiviral activity in RSV expanding use for nasal spray

Nov 19th, 2020

Starpharma today announced it has completed additional testing showing potent antiviral activity of SPL7013 against human respiratory syncytial virus (RSV). RSV is a common and very contagious virus that affects the lungs and airways. RSV is most problematic in the young and the elderly and those with weakened immune systems, or chronic heart and lung disease, including asthma. More than 177,000 adults are hospitalized and 14,000 of them die due to RSV infection in the US annually. RSV is also one of the viruses responsible for the common cold.

 

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Quarterly Cashflow and Activities Report

Oct 30th, 2020

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2020.

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Completion of Placement and SPP raises $48.9M in total

Oct 29th, 2020

Starpharma today announced that it has completed its Share Purchase Plan (SPP), raising $3.9 million. The SPP was conducted in conjunction with Starpharma’s recent institutional placement (Placement), which together have raised a total of $48.9 million. The issue of 2.6 million new shares under the SPP will be at $1.50 per share, being equivalent to the Placement share price.

 

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Starpharma (ASX:SPL) banks $5.7M government R&D tax refund

Oct 21st, 2020

The Market Herald reported that Starpharma are to receive a $5.7 million research and development (R&D) tax incentive refund from the Federal Government following the government’s program to  support companies taking on R&D that benefits Australia. To watch the full video click here.

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Starpharma receives $5.7M R&D tax incentive refund

Oct 21st, 2020

Starpharma today announced that it has received a $5.7M R&D tax incentive refund which relates to the costs of research and development during the 2020 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including for COVID-19, DEP® and VivaGel® programs.

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Shareholder Update October 2020

Oct 20th, 2020

In this issue:

>> Starpharma is expediting the development of the SPL7013 COVID‑19 nasal spray

>> Rapid progress in the DEP® irinotecan phase 2 & preparations underway for clinical combinations

>> DEP® irinotecan in combination with immuno-oncology showed superior performance in colon cancer models

>> VivaGel® BV launched in Central & Eastern Europe and Nordic region

>> Fleurstat BVgel gains expanded TGA approval to include prevention of recurrent Bacterial Vaginosis (BV) indication

>> VivaGel® BV has now been approved in 40 countries with further submissions underway

>> Starpharma awarded $1 million MRFF funding for COVID-19 nasal spray

>> DEP® docetaxel update & patient case study

>> DEP® cabazitaxel update & patient case study

>> Multiple DEP® products showcased at AACR 2020 Annual Meeting

>> New DEP® partnership signed with Chase Sun for anti-infective program

>> AstraZeneca’s AZD0466 trial opens at MD Anderson Cancer Center

>> Starpharma creates slow release soluble DEP® remdesivir

>> DEP® partnering, including Antibody Drug Conjugates

>> DEP® lutetium; impressive efficacy in human prostate cancer model

>> Outlook, Annual Report & ESG Report & recent news 

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Biotech In Focus In 2020

Oct 16th, 2020

Online financial news platform FN Arena recently published an article which highlighted six biotech ASX-listed companies that have recently been viewed positively by analysts. Starpharma was listed as one such company, stating that Bell Potter had emphasized the company’s strong growth potential. To read the full article click here

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$2B R&D win for biotech, resources

Oct 8th, 2020

Starpharma was featured in an article by Stockhead, an online publication that delivers news on ASX-listed small and mid-cap companies. The piece looked at the Federal Government’s decision to abandon plans to reduce R&D tax refund by $1.8B, and will instead add $200M in value to the incentive. The article noted Starpharma received a $4.9M tax refund in December 2019 for R&D associated with the development of its DEP drug delivery system and VivaGel BV women’s health products.

To read the full article click here.

 

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Allianz ups Starpharma stake as M&G sells

Oct 8th, 2020

On 8 October, Starpharma was included in the SMH’s live market update which reported Allianz Global Investors had upped its stake in Starpharma after buying close to 10 million additional shares. It added that the fund’s position in the company had risen from 5 to 7.1 per cent. To read the full article click here

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Share Purchase Plan offer document

Oct 7th, 2020

Starpharma provides the offer document for the Company's 2020 Share Purchase Plan (SPP).

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Starpharma completes oversubscribed A$45M placement - SPP to follow

Sep 30th, 2020

Starpharma today announced that it has raised A$45 million via a placement to domestic and international institutional, sophisticated and professional investors (“Placement”). Eligible shareholders will also have the opportunity to participate, at the same price, through a Share Purchase Plan (SPP) which is expected to raise approximately A$5 million.

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