On August 21, 2024 Starpharma (ASX: SPL, OTCQX: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its annual report and full-year financial results for the year ended 30 June 2024 (Press release, Starpharma, AUG 21, 2024, View Source;mc_eid=bf52dd3418 [SID1234646036]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"Starpharma is pleased to present its annual report and full-year financial results for the 2024 financial year. Starpharma achieved several important milestones during the year, including reporting results from multiple clinical studies, advancing key projects in our pipeline, and forming new partnerships, all of which will contribute to our continued growth.

"Our primary focus remains on delivering impactful healthcare, medical, and pharmaceutical solutions that not only drive value for our shareholders but also make a meaningful difference in the lives of people, especially those battling serious illnesses like cancer.

"We are aware of the challenges we face with our underperforming share price and small market capitalisation. Everyone at Starpharma is committed to realising our strategic imperatives – maximising DEP asset value, accelerating early asset development, and building long-term sustainability – and we are taking the necessary steps to achieve them. We are confident that reaching these goals will help to increase shareholder value, and we look forward to sharing our progress with our shareholders as it unfolds.

"Importantly, we have sufficient capital to support our objectives, with a cash balance of $23.4 million as at 30 June 2024. The completion of several clinical programs has led to a reduction in our research and development expenses, extending our cash runway. Shareholders should know that we are focusing on increasing revenue, with a number of opportunities on the horizon."

Key Financial Results

Ended the 2024 financial year with $23.4 million cash on hand.
Reported loss down 48% to $8.2M (FY23: $15.6M).
Net cash outflow of $11.8 million (FY23 $14.8 million), with cash outflow from operations of $6.9 million, down $7.4 million from FY23 ($14.3 million)
Revenue up 132% to $9.8M (FY23: $4.2M), including the one-time $6.6M cash payment from Mundipharma on termination of the VivaGel BV license and supply agreement.
Starpharma received a $7.2 million FY23 R&D tax incentive refund in October 2023, with a further FY24 R&D tax incentive refund of approximately $5.0 million expected in H1 FY25.
Operational Highlights

Reported the results from all three Phase II clinical trial programs – DEP SN38, DEP cabazitaxel, and DEP docetaxel. All three programs provided clinical validation of the DEP technology; over 350 patients have now been treated using DEP products. The trials showed promising anti-tumour activity and improvements in efficacy, including longer median progression-free survival (mPFS) and higher overall survival (OS) rates, than published data on standard-of-care treatment regimens. The DEP products also demonstrated improved tolerability profiles in patients with advanced, heavily pre-treated cancers, including lower rates of severe adverse events, compared with standard-of-care treatments. Importantly, the DEP treatments extended the lives of many patients and allowed many to live more fulfilling and enriched lives.

Confirmed plans to progress Starpharma’s DEP HER2 radiodiagnostic program towards a first-in-human clinical trial, following promising early-stage imaging data in HER2-positive (HER2+) cancers. Starpharma’s DEP radiopharmaceuticals program continues to show that DEP dendrimers are a promising, versatile, and multifunctional platform for developing precision radiotheranostics for cancer imaging and therapeutic applications. This dendrimer technology bridges the gap between small molecules and large antibodies, offering the potential to improve performance and overcome limitations associated with existing technologies and treatments.

Partnered with Medicxi, a leading life sciences investment firm, to co-found Petalion Therapeutics, an asset-centric company focusing on developing a novel cancer therapy using Starpharma’s dendrimer technology. Starpharma receives an equity holding of 22.5% in Petalion in return for licensing certain intellectual property for the research, development, and commercialisation of this potential new cancer therapy.

Presented the advantages of Starpharma’s DEP dendrimer technology in oncology at multiple international industry conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the US, the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in the US, the International Conference on Molecular Targets, co-hosted by the American Association of Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) in the US, and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Canada.

Partnered with ITROM Pharmaceutical Group to sell and distribute VivaGel BV in 13 countries across the Middle East and North Africa region. Bacterial vaginosis is highly prevalent in this region, presenting a market need and commercial opportunity for new and effective therapeutic approaches. This agreement came shortly after Starpharma terminated the VivaGel BV license to Mundipharma, regained the commercial rights to Mundipharma’s territories, and received a one-time A$6.6 million cash payment from Mundipharma.

Generated clinical evidence demonstrating the effectiveness of Viraleze in humans. The results from the post-market clinical study of Viraleze in COVID-19 patients showed that Viraleze achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of patients aged 45 and over. This data will support the regulatory transition to the new European Medical Device Regulations, which come into full effect in 2029. The findings will also support ongoing marketing and commercial activities.

Achieved Great Place to Work certification for the second consecutive year. This external recognition is a testament to our team’s positive workplace environment and company culture.

On August 21, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, AUG 21, 2024, View Source [SID1234646035]):

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Wells Fargo Healthcare Conference on Wednesday, September 4 at 11:00 AM Eastern Time
Morgan Stanley Annual Global Healthcare Conference on Thursday, September 5 at 12:20 PM Eastern Time
Baird Global Healthcare Conference on Tuesday, September 10 at 10:50 AM Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com . The replays will be available for at least 30 days following the presentation.

On August 21, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 37,975 restricted stock units of the company’s common stock to 12 newly hired non-executive officers of the company (Press release, Ultragenyx Pharmaceutical, AUG 21, 2024, View Source [SID1234646034]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of August 16, 2024, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

On August 21, 2024 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that two scientific, peer reviewed journal articles published by the Company and its research partners reached 10 citations and 4,500 reads, respectively, in August, 2024 (Press release, Propanc, AUG 21, 2024, View Source [SID1234646032]). "This shows unprecedented interest in our field from researchers and among the broader scientific community," said Dr Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer.

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The first article, which reached 10 citations, published in Scientific Reports, is entitled, "Pancreatic proenzymes treatment suppresses BXPC-3 pancreatic Cancer Stem Cell subpopulation and impairs tumour engrafting." From the publishers of Nature, it is an online, open access journal, which publishes from all areas of the natural and clinical sciences. According to an insider, Scientific Reports is published on the most prestigious site of the National Institute of Health (NIH) and considered top line coverage: View Source

Published data from the Company’s joint research and development program were generated in conjunction with the Universities of Jaén and Granada, Biosanitary Research Institute of Granada, and University Hospital, Spain. Cancer stem cells (CSCs) subpopulation within the tumour is responsible for metastasis and cancer relapse. Exposure of human pancreatic CSCs to proenzymes resulted in significant decrease of specific pancreatic CSC markers. Also, in vivo (in a living organism) anti-tumor, xenograft (tissue graft) studies demonstrated high anti-tumour efficacy against tumors induced by human pancreatic CSCs. They concluded that "proenzymes treatment is a valuable strategy to suppress the CSC population in solid pancreatic tumours."

The second article, achieved 4,500 reads, also published in Scientific Reports, entitled "A formulation of pancreatic proenzymes provides potent anti-tumor efficacy: A pilot study focused on pancreatic and ovarian cancer." Published data from the Company’s R&D program were conducted with vivoPharm Pty Ltd, Australia, and the Dove Clinic for Integrated Medicine, UK, along with the Company’s joint researchers. Highlights include anti-angiogenic (anti-tumor blood vessel formation) effects of proenzymes, along with analysis of epithelial to mesenchymal transition (EMT) markers performed on human cancer cells treated with proenzymes. The EMT is a mechanism by which cancerous cells become motile and invasive, as well as immortal, thus seeding new tumors. For online access: View Source

Additionally, clinical efficacy of a suppository formulation of pancreatic proenzymes in the context of a UK Pharmaceutical Specials Scheme, led by Dr Kenyon, where 19 from 46 patients (41.3%) with late-stage cancers, had a survival time significantly longer than expected. Mean survival of 9.0 months was significantly higher than mean life expectancy, 5.6 months, in a one-way ANOVA (analysis of variance) test (alpha = 0.05, P less than 0.05).

For diagnosed pancreatic and ovarian cancer patients, there is a 20% survival rate and a 5-year relative survival rate of 29%, respectively, according to the National Cancer Institute. The global market projection for pancreatic cancer drugs is $6.93 billion by 2030, according to Brainy Insights and for ovarian cancer drugs is $13.9 billion by 2029, according to iHealthcareAnalyst.

"Survival rates, especially for pancreatic and ovarian cancers, continue to remain low. As a result, there is a pressing market need for new therapies, but without severe, or serious side effects associated with standard treatments," said Dr Kenyon. "We look forward to advancing our lead asset, PRP, into early-stage clinical development to further improve the significant life extension I first observed using proenzymes treatment in the UK Pharmaceuticals Scheme."

About PRP:

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

To view the Company’s "Mechanism of Action" video on the Company’s lead asset, PRP, please click on the following link: View Source

On August 20, 2024 Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, reported a strategic partnership with Clinical Trial & Consulting Services (CTI), a renowned global full-spectrum research service provider, to bolster oncology-focused consulting services (Press release, Crown Bioscience, AUG 21, 2024, https://www.crownbio.com/about-us/news-and-events/crown-bioscience-partners-with-cti-to-support-consulting-services-in-oncology-drug-development [SID1234646030]). This collaboration unites decades of expertise from both organizations in oncology drug discovery and development, leveraging Crown Bioscience’s preclinical and translational models and CTI’s well-established track record in the clinical and regulatory space.

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Customers will benefit from combined expert guidance, supporting the transition of oncology compounds from discovery through early-phase clinical trials more rapidly and effectively. This alliance aims to determine the optimal and most expeditious path to the clinic, ensure long-term drug development success and growth, and accelerate the delivery of superior oncology therapeutics to patients.

From today, customers can access consulting services to ensure an integrated drug development approach, including:

Strategic preclinical development planning
Study data analysis, interpretation and advice
Regulatory guidance
De novo assay development
Grant review
Alex Slater, Senior Vice President of Commercial, commented: "Crown Bioscience has an established reputation for exceeding the typical services offered by a regular CRO. This initiative unites deep-seated expertise spanning all phases of drug development, marking a pivotal step towards delivering a true translational offer to our clients."

Ryan Gifford, Vice President of Global Laboratory Services, Business Development, shares: "We are delighted to collaborate with Crown Bioscience and view this as a valuable synergy. Crown Bioscience’s leadership in early-phase oncology research and suite of preclinical services complement CTI’s broad spectrum of capabilities. Together, we can offer enhanced support to our oncology clients and deepen our commitment to advancing cancer research."