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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 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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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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Investor Presentation

Sep 30th, 2020

Starpharma today provided its latest investor presentation.

 

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VivaGel® BV secures TGA approval for prevention of BV

Sep 25th, 2020

Starpharma today announced that the Australia Therapeutic Goods Administration (TGA) has approved an expansion of the marketing authorisation for VivaGel® BV (Fleurstat BVgel) to now include the indication of prevention of recurrent bacterial vaginosis. These expanded claims bring the approved indications for VivaGel® BV (Fleurstat BVgel) in line with those in Europe and Asia.

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Starpharma to present at OTCQX Life Sciences Investor Forum

Sep 17th, 2020

Starpharma today announced that a pre-recorded presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 17 September 2020 (US ET) as part of OTCQX’s Life Sciences Investor Forum.

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SPL7013 COVID-19 nasal spray virucidal against SARS-CoV-2

Sep 14th, 2020

Starpharma today announced it has completed additional antiviral testing for SPL7013 against SARS‑CoV-2 in studies conducted in the laboratory of internationally recognised virology researcher, Professor Philippe Gallay, at the renowned Scripps Research Institute in the US.

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Starpharma awarded $1M MRFF funding for COVID-19 spray

Sep 3rd, 2020

Starpharma today announced the award of $1 million in matched funding by the Australian Government’s Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program to expedite development and commercialisation of its COVID‑19 antiviral nasal spray based on Starpharma’s proprietary dendrimer, SPL7013.

 

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SPL creates slow release soluble DEP® remdesivir nanoparticle

Sep 1st, 2020

Starpharma today announced it has applied its novel DEP® drug delivery technology to create a long‑acting, water soluble version of remdesivir. Remdesivir is an antiviral drug, currently being developed by Gilead to treat COVID-19 and has emergency use authorisation from the US Food and Drug Administration for the treatment of COVID-19 in adults and children hospitalised with severe disease.

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Annual report and full year financial results

Aug 27th, 2020

Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2020.

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SPL7013 nasal spray for COVID-19 – development update

Aug 25th, 2020

Starpharma today announced progress with development, regulatory and manufacturing activities associated with a nasal spray for protection against COVID-19 based on the company’s proprietary antiviral dendrimer, SPL7013.

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Starpharma signs new DEP® partnership with Chase Sun

Aug 17th, 2020

Starpharma today announced that it has signed a new research partnership with leading Chinese Pharmaceutical company Tianjin Chase Sun Pharmaceutical Co., Ltd. (stock code 300026; Chase Sun), to develop several DEP® nanoparticle formulations for an anti-infective drug. The agreement also provides for the potential to conduct additional DEP® programs, which can be across therapeutic areas beyond anti-infectives.

 

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Quarterly Cashflow and Activities Report

Jul 30th, 2020

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

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DEP® docetaxel and gemcitabine combination trial commences

Jul 30th, 2020

Starpharma today announced that it has commenced its DEP® docetaxel + gemcitabine combination study for patients with advanced cancers, including pancreatic cancer. Recruitment into the study has commenced at the Christie in the UK, with two further sites expected to open in the coming weeks.

 

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AZD0466 trial opens MD Anderson Cancer Center as a site

Jul 27th, 2020

Starpharma (ASX: SPL, OTCQX: SPHRY) today announced the opening of the MD Anderson Cancer Center as a further trial site for the phase 1 trial of AZD0466, AstraZeneca’s first DEP® product.

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New Australian site opening for DEP® trials

Jul 9th, 2020

Starpharma today announced the opening of a new trial site for the phase 2 DEP® irinotecan trial, at the Kinghorn Cancer Centre in Sydney. The DEP® irinotecan trial is also being conducted at multiple leading UK cancer centres including The Christie, The Royal Marsden, Newcastle Freeman Hospital, and The Beatson West of Scotland Cancer Centre. The Kinghorn Cancer Centre will also be opened shortly as an additional site for the phase 2 DEP® cabazitaxel trial.

 

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DEP irinotecan boosts immuno-oncology in colon cancer models

Jun 29th, 2020

Starpharma today announced its SN-38 nanoparticle, DEP® irinotecan in combination with an immuno-oncology (IO) agent (anti PD-1 antibody) showed superior anti-tumour activity and significant survival benefit in two colorectal cancer (CRC) models when compared to the anti PD-1 antibody alone. These results included improvement in both survival and efficacy in the particularly aggressive CT-26 CRC model.

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Multiple DEP® products showcased at AACR 2020

Jun 23rd, 2020

Starpharma today announced that five posters featuring products based on Starpharma’s DEP® platform have been presented at the AACR (American Association for Cancer Research) Annual Meeting. The AACR Annual Meeting brings together leading cancer research and medicine from institutions all over the world and is an important forum for both raising product awareness and commercial interactions.

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DEP® lutetium effective in human prostate cancer model

Jun 17th, 2020

Starpharma today announced results from its first radiotherapeutic candidate, DEP® lutetium. DEP® lutetium is a patented nanoparticle which incorporates the radioisotope Lutetium-177 on a DEP® dendrimer scaffold. 

 

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VivaGel® BV launched in central and eastern European countries

Jun 16th, 2020

Starpharma today announced that VivaGel® BV has been launched in Central and Eastern European (CEE) region. This launch follows European launches in Germany, UK and several other European countries.

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DEP® irinotecan phase 2 commences after positive phase 1 results

May 7th, 2020

Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® irinotecan. The trial met its objective of evaluating safety, tolerability, pharmacokinetics and preliminary efficacy data, and identifying a recommended phase 2 dose. The trial will now transition seamlessly into phase 2, with recruitment activities underway at three sites. Two additional sites, The Beatson West of Scotland Cancer Centre (the Beatson) and the Kinghorn Cancer Centre in Sydney are also expected to commence recruitment shortly.

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Starpharma presents at Macquarie Australia Conference

May 5th, 2020

Starpharma has been invited to present today at the Macquarie Australia Conference. Due to COVID-19, the Macquarie Australia Conference will be a virtual conference for registered institutional investors. The event will provide international and domestic institutions with the opportunity to hear from a range of invited Australian companies over three days. Starpharma is one of a handful of companies in the pharmaceutical/biotech and healthcare industries to be presenting during the conference.

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SPL7013 shows significant activity against SARS-CoV-2 (coronavirus)

Apr 15th, 2020

Starpharma today announced that its proprietary VivaGel® active, astodrimer sodium (SPL7013), has been shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19 (coronavirus disease). SPL7013 inhibited the infection of cells with the SARS-CoV-2 virus and the finding was validated by replicate testing against a positive control compound, remdesivir (Gilead), which is considered a leading candidate for the treatment of COVID-19. The finding was also significant given that SPL7013 was reported to be the best performing test compound against SARS-CoV-2 in the laboratory’s assay to date. With these positive results, Starpharma is evaluating product concepts and formulation options for SPL7013, which may have potential applications in the prevention and management of COVID-19.

 

 

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Quarterly Cashflow and Activity Report

Apr 7th, 2020

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

Starpharma’s cash balance as at 31 March 2020 was $36.1 million, an increase of $0.2 million compared to the previous quarter’s cash balance. Net operating cash outflows for the quarter were $0.9 million, or $6.0 million for the nine months to 31 March 2020. Starpharma’s strong cash reserves and clean balance sheet places the Company in a strong position to continue to progress its commercial and R&D activities in the current uncertain global environment of the COVID-19 pandemic.

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COVID-19 measures

Mar 30th, 2020

Starpharma continues to closely monitor the COVID-19 pandemic and its impact.

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Okamoto licenses VivaGel® antiviral condom in Asian countries

Mar 4th, 2020

Starpharma today announced that following the successful launch of the VivaGel® antiviral condom by Okamoto Industries, Inc. (TYO: 5122:JP; Okamoto) in Japan, Okamoto has sought an expansion to its licence territory for the VivaGel® condom. As a result, Starpharma has granted Okamoto marketing rights to a further 11 countries in Asia which include South Korea, Indonesia, Malaysia, Thailand, Singapore and the non-government China market.

 

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Starpharma appoints David McIntyre and Appendix 3X

Mar 2nd, 2020

Starpharma today announced that Mr David McIntyre has commenced as an independent non-executive director of Starpharma, effective 1 March. Mr McIntyre’s appointment follows a comprehensive Board renewal and search process. As advised at the Company’s last AGM, Mr Richard Hazleton will be retiring at the 2020 AGM in November, having served 13 years on the Company’s Board. The timing of Mr McIntyre’s appointment enables a smooth transition and handover between directors.

 

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Interim Report and Half-Year Financial Results

Feb 24th, 2020

Starpharma today released its interim report and financial results for the half-year ended 31 December 2019.

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VivaGel BV launched in Asia

Feb 13th, 2020

Starpharma today announced that VivaGel® BV has been launched in Asia under the brand name BETADINETM BV Gel. The product has initially been launched in South East Asia, with further roll-out in additional Asian countries, as regulatory approvals are granted.  

BETADINETM BV Gel will be available over-the-counter (OTC), without the need to see a doctor or obtain a prescription. Asia is the third region to launch VivaGel® BV and represents a large commercial opportunity with access to more than 1.5 billion women.

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David McIntyre appointed as non-executive director

Feb 12th, 2020

The Board of Starpharma is pleased to announce the appointment of Mr David McIntyre as an independent non-executive director, effective 1 March 2020.

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Starpharma receives US$3M milestone from AstraZeneca

Feb 11th, 2020

Starpharma today announced it has received US$3 million (A$4.5 million) from AstraZeneca following the successful dosing of the first patient in the phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) in December.

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Shareholder Update January 2020

Jan 30th, 2020

In this issue: 

>> VivaGel® BV launched in the UK

>> AstraZeneca first DEP® product enters the clinic; triggers US$3M milestone

>> DEP® cabazitaxel trial moves into phase 2 on positive results

>> Fleurstat BVgel marketing campaign; New Zealand launch planned

>> Dual strategy to achieve approval of the NDA in the US

>> Okamoto joins forces with Japanese government for STI prevention campaign

>> VivaGel® condom receives regulatory approval in Europe

>> DEP® docetaxel & DEP® cabazitaxel clinical trial case studies

>> DEP® irinotecan phase 1/2 trial

>> New candidate - DEP® gemcitabine

>> GMP DEP® facility licence

>> DEP® combinations add further value

>> Outlook, recent news & events

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Quarterly Cashflow Report

Jan 29th, 2020

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2019.

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Commencement of phase 1 trial for AZD0466 utilising DEP®

Dec 30th, 2019

Starpharma today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

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Starpharma receives $4.9M R&D tax incentive refund

Dec 16th, 2019

Starpharma today announced that it has received a $4.9M R&D tax incentive refund which relates to the costs of research and development during the 2019 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including DEP® and VivaGel®.

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DEP® cabazitaxel progresses to phase 2 on positive results

Dec 10th, 2019

Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® cabazitaxel. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2. The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.

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AGM Chairman’s address and CEO’s presentation

Nov 21st, 2019

Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 4.00pm today.

 

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VivaGel® condom receives regulatory approval in Europe

Nov 20th, 2019

Starpharma today announced that it has been granted marketing approval for the VivaGel® condom in Europe.  

 

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UK launch of VivaGel® BV

Nov 13th, 2019

Starpharma today announced that VivaGel® BV has been launched in the UK under the brand Betafem® BV Gel. This launch follows the first European launches in June 2019, including in Germany and other countries.

 

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DEP® gemcitabine outperforms Gemzar® in human pancreatic cancer model

Oct 31st, 2019

Starpharma today announced results for its next internal development candidate, DEP® gemcitabine.

 

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Quarterly Cashflow Report

Oct 30th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.

Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.

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Starpharma to present at US Drug Delivery Conference

Oct 8th, 2019

Starpharma today announced that it has been invited once more to present at the 9th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 7-8 October.

The PODD conference showcases the latest advances in drug delivery and provides networking opportunities with senior scientific and commercial executives from many of the major international pharmaceutical companies. This year’s PODD conference will be chaired by AstraZeneca’s Head of Drug Delivery, Dr Shawn Davis.

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FDA Authorisation of First-in-Human Clinical Trial with AstraZeneca’s DEP® product AZD0466

Sep 26th, 2019

Starpharma today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.

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DEP® irinotecan synergistic with Lynparza® in refractory human colon cancer model

Sep 12th, 2019

Starpharma today announced that its patented clinical stage nanoparticle formulation, DEP® irinotecan, showed significantly enhanced efficacy benefits over standard irinotecan (Camptosar®) and olaparib (Lynparza®) alone and in combination, in an irinotecan-refractory HT-29 human colon cancer xenograft model.

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VivaGel® BV regulatory approvals continue in Asia

Sep 3rd, 2019

Starpharma today announced that it has received a further regulatory approval in an Asian country for VivaGel® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.

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Positive results with Targeted DEP® using antibody fragment in human ovarian cancer model

Aug 29th, 2019

Starpharma today announced that treatment with a novel HER-2 Targeted DEP® conjugate from its internal Targeted DEP® program resulted in tumour regression and 100% survival in a preclinical human ovarian cancer model. 

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