Half Yearly Report and Accounts
Released
Released
Announcement PDF
ASX Announcement
Appendix 4D: Preliminary Financial Report
under ASX Listing Rule 4.2A
Current reporting period: Half-year ended 31 December 2023
Prior corresponding period: Half-year ended 31 December 2022
Results for announcement to the market
$’000
Revenue from continuing operations
(Appendix 4D item 2.1)
Up
(increase)
Adjusted Revenue*
Down
(excluding Mundipharma settlement)
Loss from continuing operations after tax
attributable to members
(Appendix 4D item 2.2)
Loss for the period attributable to members
(Appendix 4D item 2.3)
Adjusted Loss*
(excluding Mundipharma settlement)
(decrease)
399%
to
$8,025
8%
to
$1,472
88%
to
$1,034
88%
to
$1,034
8%
to
$7,587
Down
(decrease)
Down
(decrease)
Down
(decrease)
*Adjusted Revenue is calculated as Revenue ($8,025,000) from continuing operations less nonrecurring
revenue of $6,553,000 relating to the commercial settlement and termination of the VivaGel® BV license
and supply agreement with Mundipharma in August 2023. Adjusted Loss likewise subtracts the above
nonrecurring revenue from the Loss for the period.
Dividends (Appendix 4D items 2.4 and 2.5)
No dividends have been paid or declared by the entity since the beginning of the current reporting period.
No dividends were paid for the previous corresponding period. No record date for determining
entitlements to dividends has been declared.
Explanation of Revenue (Appendix 4D item 2.6)
Revenue of $8,025,000 (31 December 2022: $1,607,000) for the half-year includes product sales, royalty
and license, and research revenue from commercial partners of $7,197,000 (31 December 2022:
$1,086,000), and interest income on cash invested in term deposits of $828,000 (31 December 2022:
$521,000). Revenue included a nonrecurring $6,553,000 from the commercial settlement of the VivaGel®
BV license and supply agreement with Mundipharma in August 2023. Excluding the Mundipharma
settlement, half-year adjusted revenue was $1,471,000, an 8% decrease on prior corresponding period
revenues, with lower product sales in the current period.
For further details, refer to the Interim Report which follows this announcement.
Explanation of Loss (Appendix 4D item 2.6)
The loss after tax was $1,034,000 (31 December 2022: $8,277,000 loss) and includes nonrecurring
revenue of $6,553,000 from the Mundipharma commercial settlement. The half-year includes research
and product development expense of $5,263,000 (31 December 2022: $5,599,000) net of the Australian
Government’s R&D tax incentive. Research expenditures are primarily associated with the internal DEP®
drug delivery programs including DEP® docetaxel, DEP® cabazitaxel, DEP® irinotecan, DEP® ADCs and
DEP® radiotheranostics, and the VIRALEZE™ post-market study.
For further details, refer to the Interim Report which follows this announcement.
Net Tangible Asset Backing (Appendix 4D item 3)
Net tangible asset (NTA) backing per ordinary share at 31 December 2023 is $0.08 (31 December 2022:
$0.10).
The above NTA backing calculation is considered a non-IFRS value and has not been audited or
reviewed in accordance with Australian Accounting Standards.
Appendix 4D items 4,5,6,7,8,9 are not applicable.
This report is based on the consolidated 2023 half-year financial statements which have been reviewed
by PricewaterhouseCoopers (the Company’s auditor) with the Independent Auditor’s Review Report
included within the 31 December 2023 half-year financial statements.
This information should be read in conjunction with the 30 June 2023 Annual Report and any public
announcements made by Starpharma Holdings Limited during the interim reporting period in accordance
with the continuous disclosure requirements of the Corporations Act 2001.
ASX Announcement
Interim Report and Half-Year Financial Results
•
Strong cash position with $32.1M as at 31 December 2023. Reported half-year revenue of $8M
(H1 FY23 $1.6M), including $6.6M VivaGel® BV settlement from Mundipharma. The reported
loss for the period was $1.0M (H1 FY23 $8.3M).
•
Phase 2 clinical trials of DEP® cabazitaxel, DEP® docetaxel, and DEP® irinotecan showed
positive results in treating multiple cancer types, providing further clinical validation of the DEP®
platform and highlighting its value proposition in repurposing and enhancing the therapeutic and
commercial utility of widely used cancer therapies.
•
The DEP® platform showed imaging benefits in targeted radio diagnostic approaches.
Specifically, DEP® HER2-zirconium demonstrated a favourable biodistribution profile, rapid
uptake, and high levels of tumour accumulation in a HER2+ breast cancer model.
•
Results from the Viraleze™ post-market study in participants with COVID-19 showed antiviral
efficacy, with effects more pronounced in the older patient cohorts. Viraleze™ achieved a
statistically significant reduction in SARS-CoV-2 viral load in the cohort of participants aged 45
and over. The clinical evidence generated by the Viraleze™ post-market study will support
ongoing commercial and regulatory activities.
•
Following Starpharma’s successful commercial settlement agreement with Mundipharma for
VivaGel® BV and the subsequent reversion of territorial rights over the product, Starpharma
signed a regional sales and distribution agreement for VivaGel® BV with ITROM Pharmaceutical
Group, covering 13 countries across the Middle East and North Africa (MENA) region.
Melbourne, Australia; 28 February 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today
releases its Interim Report and Half-Year Financial Results for the period ended 31 December 2023
(H1 FY24).
Starpharma’s Chief Executive Officer, Cheryl Maley, commented:
“Starpharma has made important progress towards achieving its objectives during this half. This
includes completing and reporting the results from the Phase 2 clinical trials of its DEP® candidates
and the clinical study of Viraleze™. The Company also presented the DEP® platform at multiple
industry conferences and executed a new VivaGel® BV partnership in the Middle East and North
Africa region.
“Starpharma is focused on advancing its DEP® platform towards commercialisation and building
partnerships and collaborations. The DEP® platform is highly versatile and can be applied to a wide
range of novel therapeutics, including but not limited to Antibody-Drug Conjugates (ADCs) and
radiotheranostics, offering a range of therapeutic and commercial benefits. This is supported by the
Phase 2 proof-of-concept clinical trial results and the early data in ADCs and radiotheranostics.
“In parallel, Starpharma is committed to leveraging the existing approvals of VivaGel® BV and
Viraleze™ to expand their brand recognition and sales.
“With a strong cash balance of $32.1 million (at 31 December 2023), Starpharma is well-positioned
to move forward with its pipeline and will allocate its resources in line with its strategic priorities.”
DEP® Programs
The final results from the Phase 2 clinical trial programs of DEP ® cabazitaxel and DEP® docetaxel
were reported. Recruitment for the Phase 2 clinical trial of DEP® irinotecan was completed, and
interim results were reported. Multiple scientific posters highlighting the DEP® platform were also
accepted for presentation at international cancer research conferences.
The DEP® cabazitaxel Phase 2 clinical trial met its objectives, with endpoints demonstrating antitumour efficacy in advanced, metastatic castration-resistant prostate cancer, platinum-resistant
ovarian cancer, and gastro-oesophageal cancers. The trial also confirmed the safety and tolerability
of DEP® cabazitaxel.
The key results from the Phase 2 trial of DEP® cabazitaxel in patients with advanced gastrooesophageal cancers were presented at the American Society of Clinical Oncology (ASCO)
Gastrointestinal Cancers Symposium in the US in January 2024.
The DEP® docetaxel Phase 2 clinical program demonstrated encouraging anti-tumour activity in
multiple advanced, metastatic cancers, including pancreatic cancer, gastro-oesophageal cancer,
non-small cell lung cancer, and cholangiocarcinoma. The safety and tolerability of DEP® docetaxel
were also confirmed. These results were demonstrated in the monotherapy and combination arms,
where DEP® docetaxel was administered either as a monotherapy or combination therapy with other
anti-cancer agents, nintedanib or gemcitabine.
The interim clinical data on DEP® irinotecan showed durable anti-tumour responses in advanced
colorectal cancer and platinum-resistant/refractory ovarian cancer and good tolerability across the
study. Enrolment has been completed for both the monotherapy and combination arms. Several
patients with advanced cancers, including ovarian and colorectal cancers, are continuing therapy
and are experiencing prolonged responses to treatment and significant clinical benefits.
These interim data on DEP® irinotecan were presented at the International Conference on Molecular
Targets and Cancer Therapeutics, co-hosted by the American Association of Cancer Research
(AACR), National Cancer Institute (NCI), and the European Organisation for Research and
Treatment of Cancer (EORTC) in the US in October 2023. Additional nonclinical data on DEP ®
irinotecan in combination with immuno-oncology agents were also presented at this conference.
The DEP® radiotheranostics program made progress, with Starpharma’s HER2-targeted
radiodiagnostic candidate, DEP® HER2-zirconium, demonstrating a favourable biodistribution
profile with excellent imaging contrast between tumour and normal tissues, as well as rapid uptake
and high levels of tumour accumulation in a HER2-positive (HER2+) breast cancer model. These
data were also presented at the AACR-NCI-EORTC Conference in the US in October 2023.
The application, versatility, and benefits of the DEP® platform for targeted delivery of
radiotheranostics, including an overview of Starpharma’s two DEP® HER2-targeted radiotheranostic
products, DEP® HER2-zirconium and DEP® HER2-lutetium, were also presented at the Targeted
Radiopharmaceuticals Summit in Berlin in December 2023.
On 31 July 2023, following communication from AstraZeneca on 28 July 2023 and the subsequent
release of their H1 and Q2 2023 results announcement that day, Starpharma reported that
AstraZeneca had made the decision to discontinue the development of AZD0466 after an internal
review prompted by a small number of asymptomatic adverse events that were unrelated to
Starpharma’s dendrimer drug delivery technology.
Starpharma’s in-house preclinical DEP® Antibody-Drug Conjugates (ADCs) programs continued
progressing alongside our partnered programs, including MSD and Genentech. The Company’s
partner programs involve a number of therapeutic areas, including ADCs.
A key focus for Starpharma is advancing its DEP® platform and assets towards commercialisation
through partnerships and licensing. The Company is actively supporting its existing partners and,
in parallel, is seeking and targeting new partnerships to leverage its dendrimer technology.
2
Viraleze™ and VivaGel® BV
The results of the post-market clinical study of Viraleze™ nasal spray in participants with COVID19 were reported in January 2024. Viraleze™ achieved a statistically significant reduction in SARSCoV-2 viral load in the cohort of participants aged 45 and over. Other antiviral effects were also
observed, including increased viral clearance rate from the nose, reduced time to negative PCR1
test and improvement in key symptoms, including recovery from loss of smell. As seen in a
previously announced trial in healthy volunteers, Viraleze™ was well-tolerated.
The results from the Viraleze™ clinical study provide significant clinical evidence of the performance
of Viraleze™ that will support regulatory processes for the transition to the new European Medical
Device Regulations (MDR), which will come into full effect in 2029. The data will also support
ongoing marketing and commercial activities for the product.
Starpharma continues to market Viraleze™ online through Amazon and dedicated product
websites. Starpharma also has commercial partners in several international markets, where the
product is distributed online and in retail outlets, including pharmacies.
Viraleze™ is not approved for use or supply in Australia, where the review by the Therapeutic Goods
Administration (TGA) for the SPL7013 nasal spray as a medical device is ongoing.
In February 2024, Starpharma completed the formal dispute resolution process with the US Food
and Drug Administration (FDA) in relation to VivaGel® BV. The FDA maintained its position that
they require additional clinical efficacy data to be generated for the regulatory approval of VivaGel®
BV for bacterial vaginosis (BV) in the US. Starpharma is not planning to pursue additional clinical
studies for VivaGel® BV on its own at this time but remains committed to leveraging the VivaGel®
BV development program and will work to maximise the commercial potential for VivaGel ® BV in
the more than 45 markets where it is already approved. The decision by the FDA does not alter the
approval status in the countries where VivaGel® BV is already registered.
In January 2024, Starpharma partnered with ITROM Pharmaceutical Group for the sales and
distribution of VivaGel® BV across 13 countries in the Middle East and North Africa region. ITROM
has a strong presence throughout the region’s public and private health sectors, maintaining strong
relationships with key opinion leaders, specialist physicians, hospital chains and retail outlets.
This new partnership with ITROM followed the reversion of VivaGel® BV rights to Starpharma under
a settlement agreement with Mundipharma in August 2023. Under the settlement, Starpharma
received a $6.6M cash payment from Mundipharma in August 2023, and the VivaGel® BV
commercial rights reverted to Starpharma.
Starpharma’s partner, Aspen, continues to market VivaGel® BV in Australia and New Zealand. In
Australia, VivaGel® BV is the number 1 topical brand by sales for the treatment of BV and prevention
of BV recurrence.
The Company continues pursuing additional commercial opportunities for the Viraleze™ and
VivaGel® BV products.
Starpharma and Okamoto signed a contract extension for the VivaGel® Condom product. This
agreement covers Japan and several other Asian markets. Okamoto continues marketing in Japan
and regulatory activities in a number of other Asian markets.
Financial Summary
Half-year revenues were $8.0M, including revenue from commercial partners of $7.2M (H1 FY23:
$1.1M) and interest income of $0.8M (H1 FY23: $0.5M). Revenue included a nonrecurring $6.6M
from the commercial settlement of the VivaGel® BV licence and supply agreement with
1
Polymerase chain reaction.
3
Mundipharma in August 2023. Excluding the Mundipharma settlement, the half-year adjusted
revenue was $1.5M, an 8% decrease on H1 FY23, with lower product sales in the current period.
The half-year loss after tax was $1.0M (H1 FY23: $8.3M) and includes research and product
development expenses of $5.3M (H1 FY23: $5.6M) net of the Australian Government’s R&D tax
incentive. Research expenditures were primarily associated with Starpharma’s internal DEP® drug
delivery programs, including DEP® docetaxel, DEP® cabazitaxel, DEP® irinotecan, DEP® ADCs and
DEP® radiotheranostics, and the Viraleze™ post-market study.
During the period, Starpharma received a $7.2M R&D tax incentive and repaid the $4.0M lowinterest R&D loan with the Treasury Corporation of Victoria. Starpharma’s balance sheet remains
strong, with a closing cash position of $32.1M at 31 December 2023.
About Starpharma
Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a world leader in dendrimer technology for medical applications. As an innovative
Australian biopharmaceutical company, Starpharma is focused on developing and commercialising novel therapeutic products that address significant
global healthcare needs. Starpharma boasts a strong portfolio of products, partnerships, and intellectual property.
Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically manufactured, nanoscale
molecules. The unique properties of dendrimers – including their size, structure, high degree of branching, polyvalency, and water solubility – are
advantageous in medical and pharmaceutical applications.
Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing pharmaceuticals. Starpharma’s
portfolio includes multiple clinical-stage oncology products, which utilise its Dendrimer Enhanced Product (‘DEP ®’) drug delivery technology, and
marketed products, including VIRALEZE™ and VivaGel® BV, which utilise SPL7013, a proprietary dendrimer with antimicrobial properties.
Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to reduce drug-related
toxicities through controlled and specified drug delivery.
In addition to Starpharma’s internal DEP® programs, Starpharma has multiple DEP® partnerships with international biopharmaceutical companies,
including AstraZeneca (oncology), MSD (Antibody-Drug Conjugates), Chase Sun (anti-infectives), and other world-leading pharmaceutical
companies. Due to the broad applicability and optionality of Starpharma’s DEP ® platform, partnered DEP® programs have the potential to generate
significant future milestones and royalties.
Starpharma’s topical nasal spray, Viraleze™, is registered in more than 35 countries, including Europe, the UK, and Asia. Starpharma’s novel nonantibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV, is registered in more than 50 countries,
including in the UK, Europe, Southeast Asia, South Africa, Australia and New Zealand.
For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn.
WE Communications
Hannah Howlett
+61 450 648 064
WE-AUStarPharma@weworldwide.com
Starpharma Holdings Limited
Cheryl Maley, Chief Executive Officer
Justin Cahill, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement was
authorised for release by the Chair,
Mr Rob Thomas.
Forward-Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking
terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”,
“potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied
discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance
or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the
FDA’s and other authorities’ requirements regarding any one or more product candidates, nor can there be any assurance that such product
candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s
expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial
results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our
ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general
public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results
and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those described herein as anticipated, believed, estimated, or expected. Starpharma is providing this information as
of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of
new information, future events or developments or otherwise. Clinical case studies and other clinical information given in this document are given for
illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the
likelihood of achievement or reasonableness of future results. Nothing contained in this document, nor any information made available to you is, or
shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.
4
Starpharma Holdings Limited
ABN 20 078 532 180
Interim Report
FOR THE HALF-YEAR ENDED 31 DECEMBER 2023
This information should be read in conjunction with the 30 June 2023 Annual Report and any public announcements made by
Starpharma Holdings Limited during the interim reporting period in accordance with the continuous disclosure requirements of
the Corporations Act 2001.
Contents
Directors’ Report
2
Auditor’s Independence Declaration
6
Interim Financial Report
7
Independent Auditor’s Review Report to the Members
16
Interim Report – 31 December 2023
Starpharma Holdings Limited
1
Directors’ Report
The directors are pleased to present this report on the consolidated entity (referred to hereafter as the “Group”, “Company”, or
“Starpharma”) consisting of Starpharma Holdings Limited (the “Parent Entity”) and the entities it controlled at the end of, or during,
the half-year ended 31 December 2023.
Directors
The following persons were directors of Starpharma Holdings Limited during the whole of the half-year and up to the date of this
report unless otherwise stated:
R B Thomas, AO (Chairman)
L Cheng
D J McIntyre
J R Davies
R Basser
J K Fairley (retired as Chief Executive Officer and Managing Director on 8 January 2024)
C Maley (appointed as Chief Executive Officer and Managing Director on 8 January 2024)
Principal Activities
The principal activities of the Group consist of research, development and commercialisation of dendrimer products for
pharmaceutical and healthcare applications. Activities within the Group are directed towards the development of precisely
defined nano-scale materials, including the development of SPL7013 (astodrimer sodium) as a vaginal gel, VivaGel® BV, for the
management of bacterial vaginosis; Viraleze™ antiviral nasal spray; and as an antiviral condom coating. Starpharma is also
applying its proprietary dendrimers to drug delivery to create improved pharmaceuticals and has developed the valuable DEP®
(Dendrimer Enhanced Product) delivery platform.
Strategy, Future Developments and Prospects
The Company aims to generate value through the clinical development and commercialisation of its proprietary products, as well
as partnerships with pharmaceutical and biotechnology companies based on its patented dendrimer technology in
pharmaceutical and healthcare applications. The Company’s key focus is to advance its DEP® programs and to fully leverage
partnerships in target markets for VivaGel® and Viraleze™. Starpharma intends to achieve this by continuing to utilise a
combination of internally funded and partnered projects across its dendrimer portfolio. The Company commercialises its
development pipeline with corporate partners via licensing, and sales and distribution agreements at various stages in a product’s
development lifecycle; depending on the product, patent opportunity, a partner’s commercial strategy and relative strength of
product and market expertise, comparison of current and future potential returns.
Starpharma has extensive expertise, a strong intellectual property portfolio, a diverse product portfolio, and a strong cash
position. Going forward, Starpharma’s strategy is to extract the highest value from its patented DEP® technology, as well as its
marketed products VivaGel® BV and Viraleze™. Efforts to achieve this will be increasingly focused on key markets and supported
by a strengthened commercial capability.
Dividends
No dividends have been paid or declared by the Company during the current reporting period. No dividends were paid for the
previous corresponding period.
Review of Operations
DEP® Drug Delivery Platform
Starpharma’s DEP® platform is being used to enhance the therapeutic utility of drugs through improved solubility, efficacy and
pharmacokinetic control, and reductions in certain drug-related toxicities. Starpharma’s innovative and proprietary DEP® platform
has shown advantages across a wide range of drug classes. It has the potential to provide benefits to small molecule drugs,
peptides and proteins and in the development of DEP® Antibody-Drug Conjugates (ADCs) and radiotheranostics. The dendrimer
technology could provide benefit to companies looking to extend patents of key drugs in their portfolio or looking to enhance the
outcome of a drug currently in development to improve efficacy and / or reduce toxicity.
Key activities until the date of this report include:
The final results from the Phase 2 clinical trial programs of DEP® cabazitaxel and DEP® docetaxel were reported. Recruitment for
the Phase 2 clinical trial of DEP® irinotecan was completed, and interim results were reported.
The DEP® cabazitaxel Phase 2 clinical trial met its objectives, with endpoints demonstrating positive anti-tumour efficacy in
advanced, metastatic castrate-resistant prostate cancer, platinum-resistant ovarian cancer, and gastro-oesophageal cancers.
The trial also confirmed the safety and tolerability of DEP® cabazitaxel.
Interim Report – 31 December 2023
Starpharma Holdings Limited
2
The key results from the Phase 2 trial of DEP® cabazitaxel in patients with advanced gastro-oesophageal cancers were presented
at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2024.
The DEP® docetaxel Phase 2 clinical program met its objectives, with endpoints demonstrating encouraging anti-tumour activity
in multiple advanced, metastatic cancers, including pancreatic cancer, gastro-oesophageal cancer, non-small cell lung cancer,
and cholangiocarcinoma. The safety and tolerability of DEP® docetaxel were also confirmed. These results were demonstrated in
the monotherapy and combination arms, where DEP® docetaxel was administered either as a monotherapy or combination
therapy with other anti-cancer agents, nintedanib or gemcitabine.
The interim clinical data on DEP® irinotecan showed durable anti-tumour responses in advanced colorectal cancer and platinumresistant/refractory ovarian cancer and good tolerability across the study. Enrolment has been completed for both the
monotherapy and combination arms. Several patients with advanced cancers, including ovarian and colorectal cancers, are
continuing therapy and are experiencing prolonged responses to treatment and significant clinical benefits.
These interim data on DEP® irinotecan were presented at the International Conference on Molecular Targets and Cancer
Therapeutics, co-hosted by the American Association of Cancer Research (AACR), National Cancer Institute (NCI), and the
European Organisation for Research and Treatment of Cancer (EORTC) in the US (AACR-NCI-EORTC) in October 2023. Additional
nonclinical data on DEP® irinotecan in combination with immune-oncology agents were also presented at this conference.
The DEP® radiotheranostics program made progress, with Starpharma’s HER2-targeted radiodiagnostic candidate, DEP® HER2zirconium, demonstrating a favourable biodistribution profile with excellent imaging contrast between tumour and normal tissues,
as well as rapid uptake and high levels of tumour accumulation in a HER2-positive (HER2+) breast cancer model. These data were
also presented at the AACR-NCI-EORTC Conference in October 2023.
The application, versatility, and benefits of the DEP® platform for targeted delivery of radiotheranostics, including an overview of
Starpharma’s two DEP® HER2-targeted radiotheranostic products, DEP® HER2-zirconium and DEP® HER2-lutetium, were also
presented at the Targeted Radiopharmaceuticals Summit in Berlin in December 2023.
On 31 July 2023, following communication from AstraZeneca on 28 July 2023 and the subsequent release of their H1 and Q2 2023
results announcement that day, Starpharma reported that AstraZeneca had made the decision to discontinue the development of
AZD0466 after an internal review prompted by a small number of asymptomatic adverse events that were unrelated to
Starpharma’s dendrimer drug delivery technology.
Starpharma’s in-house preclinical DEP® Antibody-Drug Conjugates (ADCs) programs continued progressing alongside our
partnered programs, including MSD and Genentech. The Company’s partner programs involve a number of therapeutic areas,
including oncology and ADCs.
A key focus for Starpharma is advancing its DEP® platform and assets towards commercialisation through partnerships and
licensing. The Company is actively supporting its existing partners and, in parallel, is seeking and targeting new partnerships to
leverage its dendrimer technology.
Viraleze™ and VivaGel® BV
Starpharma’s topical nasal spray, Viraleze™, is registered in more than 35 countries, including Europe, the UK, and Asia. (Viraleze™
is not approved for use or supply in Australia). VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention of
recur
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