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Quarterly Activities/Appendix 4C Cash Flow Report
April 30, 2024
BPH Global Limited (ASX: BP8) (“BP8” or the “Company” or the “Group”), a plant-based biotechnology company, today released its Appendix 4C and Quarterly Activities Report for the period ended 31 March 2024.
Corporate activities
BP8 ended the quarter with cash of approximately $0.257 million ($0.367 million at 31 December 2023).
On 23 April 2024, the Company issued a notice of general meeting to be convened on 24 April 2024 (Notice of Meeting) at which the Company will seek shareholder approval pursuant to ASX Listing Rule 7.1 to undertake a share placement to sophisticated and professional investors. The share placement authority is for the Company to raise up to $1,000,000. Further details regarding the proposed share placement can be found in the Notice of Meeting.
Total aggregate cash payments of $56,000 were made during the quarter to related parties and their associates as remuneration. Details of these payments are included in items 6 of the Appendix 4C.
Renewal of China Tobacco Sales and Distribution Agreements
Following the Company’s acquisition of Foshan Gedishi Biotechnology Co Ltd (Foshan) in the December quarter, the Company announced on 6 February 2024 the renewal of the two (2) sales and distribution agreements from 2023 between the Company’s now wholly owned subsidiary Foshan and two (2) wholly owned subsidiaries of China Tobacco based in Guangzhou City in the Province of Guangdong (2023 Agreements). The two wholly owned subsidiaries are Guangzhou Gold Leaves Franchise Co Ltd (Golden Leaves) and Guangzhou City Twenty Sticks Commercial Franchise Co Ltd (Twenty Sticks).
The principal terms of the 2024 Agreements include:
- commencement date 1 January 2024;
- term 12 months;
- products to be supplied:
- pure bird’s nest 50g box;
- pure bird’s nest 100g box; and
- bird’s nest drink - each box contains 3 bottles with 1.5g bird nest content; and
- products to be sold in China Tobacco outlets in the Guangzhou Province of China.
Initial sales results
Foshan commenced its sales of bird’s nest products as the Company’s wholly owned subsidiary in early January 2024 in the lead up to Chinese (Lunar) New Year (which commenced in early February 2024).
Click here for the full ASX Release
This article includes content from BPH Global Ltd, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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01 December 2021
BPH Global
Stemcell United Ltd is a marine and agricultural biotechnology industry. Its only operating segment being sourcing, producing, marketing, and selling traditional medicines. The company's geographical segment includes Australia; Singapore; Malaysia and Greater China. The company's product includes Cannabis sativa; Dendrobium Officinale and Daemonorops Draco Blume.
17h
Radiopharm Theranostics Targets Nasdaq Listing by End of 2024
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, today announced it expects to obtain a secondary listing on the Nasdaq Capital Market by the end of 2024.
As announced on 14 February 2023, the Company initiated the process to obtain a secondary listing on the Nasdaq Capital Market. Due to market conditions, the Company subsequently delayed the process.
As announced on 25 June 2024, as part of a A$70 million capital raising, the Company agreed with certain US institutional investors to seek a listing of its ordinary shares in the form of American Depositary Shares on Nasdaq by the end of 2024.
Yesterday the Company filed an amendment to its registration statement on Form 20-F with the US Securities and Exchange Commission (SEC) and is continuing to progress a listing application with Nasdaq. The Company expects the SEC and Nasdaq to complete their respective review processes by late August and, when their processes are successfully completed, then the listing on Nasdaq would occur.
The Nasdaq listing will take the form of a Level 2 American Depositary Receipt program, with each American Depositary Share representing 200 ordinary shares, and will not involve the raising of any capital. The American Depositary Shares (ADS) are expected to trade on Nasdaq under the ticker RADX. Deutsche Bank Trust Company Americas will be appointed by the Company as depositary, custodian and registrar of the ADS.
The Nasdaq listing will complement the existing primary listing of RAD shares on the Australian Securities Exchange (ASX) with minimal additional administration. Ordinary shares are currently listed on the ASX under the RAD symbol where they will continue to trade following the Nasdaq listing.
"We are confident that obtaining a listing on Nasdaq will complement our loyal existing Australian shareholder base by expanding Radiopharm’s access to investors globally, and thereby drive increased shareholder value with enhanced liquidity for all shareholders," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
This program is part of an ongoing strategy to expand the Company’s reach to US institutional and retail investors by enabling them to purchase the Company’s shares via a US stock market, in the American time zone and in US dollars.
The review process by the SEC in relation to the registration statement and by Nasdaq in relation to the listing application continues to be in progress. There can be no assurance as to the completion or timing of this process or such a listing.
Authorised on behalf of the Radiopharm Theranostics board of directors by Executive Chairman Paul Hopper.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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10 July
Top 5 NASDAQ Biotech Stocks of 2024
The NASDAQ Biotechnology Index (INDEXNASDAQ:NBI) has traded at three-year highs in the first half of 2024 in response to looming interest rate cuts, breakthrough innovations and increased deals in the space.
After dropping to a low of 3,637.05 in October 2023, the index climbed to start 2024 at 4,457.02. It did hit a bump in the road early in Q2 when it plunged to 4,056.3 in April, but it quickly recovered and has since tracked even higher, reaching 4,634.21 on June 24. But while the current economic environment means the biotech sector may have a complex road ahead, robust growth could be in store in the future.
According to a recent report from Precedence Research, the global biotech market is expected to grow at a compound annual growth rate of 11.8 percent from now to 2033, reaching a valuation of US$4.25 trillion.
Driving that growth will be favorable government policies, investment in the sector, increased demand for synthetic biology and a rise in chronic disorders such as cancer, heart disease and hypertension.
The top NASDAQ biotech companies have seen sizeable share price increases this past year. For those interested in investing in biotech companies, here are the top gainers outlined below.
Data was gathered on July 8, 2024, using TradingView’s stock screener, and all NASDAQ biotech stocks had market caps between US$50 million and US$500 million at that time.
1. Elevation Oncology (NASDAQ:ELEV)
Year-to-date gain: 416.67 percent; market cap: US$152.17 million; share price: US$2.79
Elevation Oncology’s focus is on developing cancer therapies targeting a range of solid tumors. The company’s oncology pipeline is based on its expertise in antibody-drug conjugates (ADC) and includes lead candidate EO-3021, which is designed to target solid tumors associated with gastric, gastroesophageal junction, pancreatic or esophageal cancers.
In April, Elevation presented preclinical data demonstrating proof-of-concept for its HER3-ADC program targeting solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer.
In late June, Elevation announced the expansion of its ongoing Phase 1 clinical trial for EO-3021 to include two combination cohorts evaluating the drug for the treatment of advanced gastric or gastroesophageal junction cancer. This expansion will see the company evaluating EO-3021 in combination with Eli Lily's (NYSE:LLY) ramucirumab, a VEGFR2 inhibitor, in second-line patients, and in combination with GSK's (LSE:GSK) dostarlimab, a PD-1 inhibitor, in the front-line setting.
Elevation Oncology's share price reached the highest point in 2024 on March 1, hitting US$5.01. While it's no longer at that peak, the company's stock is still up considerably from the start of the year.
2. Candel Therapeutics (NASDAQ:CADL)
Year-to-date gain: 287.92 percent; market cap: US$171.69 million; share price: US$5.77
Candel Therapeutics is another NASDAQ biotech company focused on developing oncology treatments. The company’s pipeline includes two clinical stage multimodal biological immunotherapy platforms.
Candel’s lead product candidate CAN-2409 is in a Phase 2 clinical trial in non-small cell lung cancer and borderline resectable pancreatic cancer, as well as Phase 2 and 3 trials for localized, non-metastatic prostate cancer. Positive interim data for the trial on pancreatic cancer, released on April 4, sent the company's share price spiking upwards.
Its second lead product candidate is CAN-3110, which is in an ongoing Phase 1 clinical trial in recurrent high-grade glioma (HGG).
The company has had a number wins with the US Food and Drug Administration (FDA) so far this year. In February, Candel’s CAN-3110 received regulatory approval for a fast track designation for the treatment of recurrent HGG. The agency also granted Candel orphan drug designation for CAN-2409 for the treatment of pancreatic cancer in April and CAN-3110 for HGG in May.
This NASDAQ biotech stock has had an excellent second quarter this year. After spiking on positive interim trial data for CAN-2409 in April, it continued climbing to hit a year-to-date high of US$14.00 on May 15.
3. Benitec Biopharma (NASDAQ:BNTC)
Year-to-date gain: 201.25 percent; market cap: US$90.58 million; share price: US$9.67
California-based Benitec Biopharma is advancing novel genetic medicines via its proprietary “Silence and Replace” DNA-directed RNA interference platform. The company is currently focused on developing therapeutics for chronic and life-threatening conditions including oculopharyngeal muscular dystrophy (OPMD). Its drug candidate BB-301 was granted orphan drug designation by the FDA and the European Medicines Agency.
In April, Benitec reported positive interim clinical trial data for its first OPMD subject treated with BB-301 in its Phase 1b/2a study. Following the report, Benitec's share price began trending upward, and reached its highest point in 2024 on May 20 when it hit US$10.47. The company expects to report additional interim safety and efficacy data in the second half of the year.
4. Eliem Therapeutics (NASDAQ:ELYM)
Year-to-date gain: 151.11 percent; market cap: US$452.81 million; share price: US$6.78
Eliem Therapeutics is undergoing a transformation this year following the acquisition of private biotech firm Tenet Medicines in June. Going forward, Eliem’s focus will be on developing therapeutics for autoimmune-driven inflammatory diseases. Its lead product candidate is now TNT119, an anti-CD19 antibody targeting a range of autoimmune diseases, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy.
Eliem has also completed a US$120 million private placement bringing its total cash and cash equivalents of approximately US$220 million. The company says its planned operations are now sufficiently funded into 2027, and expects to initiate Phase 2 clinical trials of TNT119 this year.
Eliem is another NASDAQ biotech stock that had a great second quarter this year, posting a year-to-date high of US$10.20 on May 7.
5. Cardiol Therapeutics (TSX:CRDL)
Year-to-date gain: 128.77 percent; market cap: US$129.03 million; share price: US$1.87
Biopharma company Cardiol Therapeutics is developing novel treatments for inflammation and fibrosis in cardiovascular conditions, including pericarditis, myocarditis, and heart failure.
The company has two drug candidates in its pipeline: CardiolRX, an orally administered cannabidiol under clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis; and CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
The FDA granted CardiolRx orphan drug designation in February. Cardiol released positive top-line results in mid-June for its Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. The company believes the results will support moving the drug to Phase 3 clinical trials.
The positive news flow contributed to the strong momentum the stock has enjoyed this year, leading to a year-to-date share price high of US$2.91 on June 12.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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10 July
First Patient Dosed with PD-L1 Nanobody in Phase 1 Therapeutic Non-Small Cell Lung Cancer Trial
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer.
- First patient dosed with RAD 204 (PD-L1 nanobody) in a Phase 1 therapeutic trial at Wollongong Hospital, New South Wales.
- Phase 11 First-In-Human study designed to assess safety and tolerability of 177Lu-RAD204 in PD-L1-positive individuals with metastatic Non-Small Cell Lung Cancer (NSCLC).
- 16 patients previously dosed in Phase 1 diagnostic study demonstrated safety and effective biodistribution, and validate the strong potential for 177Lu-RAD204 for the treatment of advanced NSCLC.
- First patient dosed with RAD 204 marks a significant milestone in Radiopharm’s commitment to developing transformative oncology radiotherapeutics.
The open-label Phase 1 study, entitled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is a First-In-Human dose escalation trial of 177Lu-RAD 2041, and is designed to evaluate the safety and preliminary efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC. Previously published2 Phase I data of 16 NSCLC patients imaged with RAD 204 have demonstrated that the diagnostic is safe and associated with acceptable dosimetry.
The study is currently being conducted in Australia at Wollongong Hospital (NSW), Princess Alexandra Hospital (QLD), and Hollywood Private Hospital (WA), with the support of GenesisCare CRO.
“Radiopharm is delighted to announce this important milestone in our evolution to a clinical-stage company,” said Riccardo Canevari, CEO and Managing Director of Radiopharm. “Despite progressive improvements in the first-line setting for metastatic NSCLC, the majority of patients will progress and require further therapeutic options in the second-line setting. Current options following progression offer modest activity, making this setting an area of unmet need. With RAD 204, we hope to provide an alternative strategy that can improve clinical outcomes for NSCLC patients, while preserving quality of life.”
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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04 July
Can AI Help Detect Cancer? Data Analysis Could Open Up Possibilities for Healthcare Industry
Artificial intelligence (AI) has emerged as a valuable tool for solving complex societal issues, and although it's a new industry, its impact is already being felt in key areas of the life science sector.
AI models in healthcare are quickly advancing beyond basic tasks like medical transcription and administrative streamlining; many systems can now effectively analyze extensive genetic data.
By harnessing AI models' ability to identify patterns and make predictions, medical professionals can institute more effective, personalized treatments and develop precision tests to catch diseases earlier.
At this year’s Collision event, held in Toronto from June 18 to 20, Wesley Chan, co-founder and managing partner at venture capital firm FPV Ventures, shared insights on AI's role in healthcare with Fox Business correspondent Susan Li.
Chan said that while the life science market has been somewhat overlooked in the AI boom so far, his company predicts that it will benefit greatly from AI technology over the next five to 10 years.
“We’re in a lot of life science companies,” he said about FPV Ventures. “A lot of them use AI to help accelerate drug discovery, or to validate their thesis or to test out some of their assumptions without having to go in depth.”
Guardant using liquid biopsy tests to look for signs of cancer
Liquid biopsies, a non-invasive blood test, have shown strong promise in cancer detection, especially when it comes to monitoring ongoing treatment and detecting cancer recurrence.
Speaking at Collision, Dr. Craig Eagle, chief medical officer at large-cap biotechnology company Guardant Health (NASDAQ:GH), outlined SHIELD, a blood test his company has developed to screen for colorectal cancer.
“One of the things that’s challenging in oncology is that the cause of the disease is a molecular abnormality, often centered around the DNA. That abnormality can either be purely inherited or environmental, but for most people it’s in between," he explained to the audience at the conference.
Standard cancer diagnosis procedures typically involve retrieving a tissue sample, which Dr. Eagle said represents a challenge when the suspected cancer is deep within the body.
“So what we’re developing is blood-based testing. A simple tube of blood, no different to what you can do with a cholesterol or diabetes sugar test," he said on stage at the event, noting that during cell growth and turnover, some cancer cells are shed into the bloodstream. Liquid biopsy is a method of cancer detection that analyzes these shed cells to look for cancer signals in the bloodstream. Blood tests can also help physicians monitor cancer as it progresses and changes, which can help them develop the best treatment plan for each individual patient.
“You can't really treat or manage a cancer or disease unless you understand it. So by understanding the deeper molecular causes of cancer, we're actually able to get those insights even further and enable informed decision making," Dr. Eagle commented. "A simple liquid biopsy test gets the information you need at the molecular level."
How were liquid biopsy tests first developed?
One of the earliest liquid biopsy tests was the prostate-specific antigen test, which was approved by the US Food and Drug Administration (FDA) in 1986. It was initially only used to monitor cancer that had already been diagnosed, but in 1994 physicians began using it alongside digital rectal exams to screen for cancer signals in men over 50.
Later, researchers developed liquid biopsy tests that searched for two types of biomarkers in blood samples: circulating tumor cells (CTCs), which have detached from the primary tumor and entered the bloodstream, and circulating tumor DNA (ctDNA), smaller fragments that enter the blood when cancer cells die and break apart.
Ongoing efforts have been devoted to developing more comprehensive liquid biopsy tests. A 1999 study that detected aberrant p16 methylation in the blood of liver cancer patients provided the concept that biomarkers more specific to certain types of cancer can be detected in the blood. The completion of the Human Genome Project in 2003 helped further develop comprehensive cancer detection methods, including liquid biopsy tests.
The Cancer Genome Atlas was launched in 2006. It maps out the genomic changes in cancer and provides insights into its molecular basis, creating a clearer picture of cancer-specific biomarkers. Technologies like next-generation sequencing and microfluidic technologies were developed concurrently, enhancing the sensitivity of liquid biopsy tests by enabling the detection of rare cancer biomarkers. These new technologies also reduced costs and improved throughput.
Additionally, since the early 2000s the FDA has granted approval to multiple technologies specifically designed to capture and enumerate CTCs. Prior to the FDA's approval of CellSearch tumor detection technology for metastatic breast cancer in 2004, finding CTCs was challenging due to the rarity of these cells in the bloodstream. The development of the CellSearch technology revolutionized CTC detection by offering a non-invasive and highly sensitive approach.
Furthermore, the CellSearch technology helped researchers gain insights into the genomic alterations and signaling pathways that drive tumor growth, which can be used to tailor treatments to target specific molecular vulnerabilities.
Harnessing AI for better cancer detection
Guardant is one of the few companies with FDA-approved liquid biopsy companion diagnostic tests in the US market, and Dr. Eagle presented a compelling case for the widespread adoption of liquid biopsies in oncology.
He stressed that liquid biopsy tests offer a more effective and accessible way to test for cancer when compared to traditional screening methods. They are non-invasive and can easily be administered during other standard blood tests, eliminating the need for additional appointments or specialized equipment.
Dr. Eagle also noted that the convenience and simplicity of regular screenings would likely encourage more patients to participate, as they can be seamlessly integrated into their ongoing healthcare routines.
Aside from that, he pointed out that traditional cancer screenings can pose accessibility challenges for patients due to various barriers, such as geographical constraints, financial limitations or other factors. These obstacles can lead to prolonged waiting periods or limited access to procedures like colonoscopies, stool or tissue sample collection and imaging scans. Additionally, liquid biopsy tests provide results sooner than other methods. Meanwhile, the simplicity of the tests, combined with their ability to detect multiple cancer types, reduces their overall cost.
Liquid biopsies also have the potential to help researchers recognize signals of other diseases. Dr. Eagle explained that DNA damage is used as a metric to assess an individual's risk of developing a disease.
Rather than focusing only on the DNA sequence itself, epigenetics — the study of how genes are expressed and regulated — can help researchers understand the role of gene expression in cancer development and progression, as well as provide additional information about a person’s health.
“So that programming now becomes a massive database that we get to see in liquid biopsy,” said Dr. Eagle.
This is where AI becomes the most crucial. He emphasized that AI analytics will accelerate over the next five to 10 years, and that this technology will be essential for the successful analysis of enormous data sequences. He believes that there will be a rapid evolution in the field of oncology from its current state.
“We've got trials going on in smokers looking for lung cancer from a blood test, and we're seeing if we can break the back of that challenge. We're also looking at multiple cancers beyond that, whether it be lung cancer in nonsmokers, whether it be liver cancer, kidney cancer, breast cancer, etc. They're all going to be from a blood test.”
Investor takeaway
The integration of AI with innovative technologies like liquid biopsies holds immense potential to revolutionize disease detection, treatment and monitoring. These developments could pave the way for a future where personalized, preventative medicine becomes the norm.
Don’t forget to follow us @INN_Technology for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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03 July
Top 3 Canadian Biotech Stocks of 2024
Biotech is a dynamic industry that is driving scientific advancements and innovation in healthcare.
According to Grandview Research, the global biotech market was worth US$1.55 trillion in 2023, and the firm expects it to grow at a CAGR of 13.96 percent between 2024 and 2030 to reach a value of US$3.08 trillion.
In Canada, the biotech industry is home to companies pursuing cutting-edge therapies and medical technologies, and the Investing News Network has identified the top three biotech stocks based on their year-on-year gains.
Data on Canadian biotech stocks was collected on July 2, 2024, using TradingView's stock screener and companies listed had market capitalizations of over C$50 million at that time. Companies on the TSX, TSXV and CSE were considered, but no TSXV-listed stocks made the list this time. Read on to learn what's been driving these biotech firms.
1. ME Therapeutics Holdings (CSE:METX)
Year-on-year gain: 7,900 percent; market cap: C$93.45 million; share price: C$4.00
ME Therapeutics Holdings is a biotechnology company focused on developing cancer-fighting drug candidates that can increase the efficacy of current immuno-oncology drugs by targeting suppressive myeloid cells, which have been found to hinder the effectiveness of existing immuno-oncology treatments. Immuno-oncology is a relatively new area of cancer drug research, and has shown promising results when used to treat cancer with low survival rates.
In December 2023, ME Therapeutics announced that its most advanced preclinical asset, h1B11-12, an antibody targeting G-CSF, had been found to bind to and neutralize G-CSF in lab tests and animal studies. Studies conducted with Dr. Kenneth Harder’s laboratory at the University of British Columbia revealed that G-CSF is involved in many different processes influencing how breast and colon cancers grow and spread.
In a January update, ME Therapeutics shared that preliminary results for clinical trials of h1B11-12 on non-human primates were tolerated well up to a dose of 10 milligrams per kilogram. The next step is to study how the drug behaves inside the body, which will help the company plan future research and decide how to continue developing h1B11-12.
ME Therapeutics saw a major share price boost on February 27, when it announced a non-brokered private placement to raise gross proceeds of up to C$1.55 million. It said it was unaware of any other change that would account for the rise.
2. Medicenna (TSX:MDNA)
Year-on-year gain: 172.86 percent; market cap: C$153.89 million; share price: C$1.91
Medicenna is a clinical-stage immuno-oncology company specializing in the development of innovative therapies for patients with challenging unmet needs. Its focus is on creating novel, highly selective versions of cytokines, such as IL-2, IL-4, and IL-13, which it refers to as "Superkines" and "empowered superkines."
Cytokines are small proteins that play a crucial role in regulating immune responses and helping cells communicate. Interleukins, which Medicenna says are at the core of its therapies, are groups of cytokines. The company's interleukins are engineered to fuse with specific molecules to optimize their function.
Medicenna's mission is to leverage its expertise in cytokine biology to design life-changing therapies that can potentially transform people's lives. Its therapies treat solid tumors, which have a low response rate to conventional cancer treatments, and autoimmune and neuroinflammatory diseases.
In April, the company shared the news that its lead candidate, MDNA11 has demonstrated therapeutic activity and an acceptable safety profile during clinical trials of monotherapy dose escalation in treating patients with advanced solid tumors. Late in the month, the company also closed on a C$20 million investment from RA Capital Management. The positive news flow provided enough momentum to push shares of Medicenna to a year-to-date high of C$2.85 on May 31.
More recently, Medicenna received regulatory approval for the European Medicines Agency to expand its phase 1/2 clinical trial of MDNA11 as a monotherapy and in combination with Keytruda to Europe.
3. Cardiol Therapeutics (TSX:CRDL)
Year-on-year gain: 116 percent; market cap: C$188.37 million; share price: C$2.70
Cardiol Therapeutics is a biopharma company developing innovative treatments for inflammation and fibrosis in cardiovascular conditions. Its research is concentrated on pericarditis, which is inflammation of the membrane surrounding the heart; myocarditis, or inflammation of the heart muscle; and heart failure.
Cardiol currently has two drug candidates in its pipeline. CardiolRX, the company's lead candidate, is an orally administered cannabidiol that is being clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis. Cardiol is also developing CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
The company's share price began a significant rise in mid-February, when the US Food and Drug Administration granted it orphan drug designation for CardiolRx. Less than a week later, Cardiol completed patient enrollment in a Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis.
The company went on to release positive top-line results in mid-June, which Cardiol President and CEO David Elsley said demonstrated "that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation." The company believes the results will help move the drug to Phase 3 clinical trials.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Cardiol Therapeutics is a client of the Investing News Network. This article is not paid-for content.
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01 July
Investor Webinar – 3pm AEST Tuesday 2 July
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that CEO and Managing Director Riccardo Canevari and Executive Chairman Paul Hopper will conduct an investor webinar to provide an update following announcement of the Company’s $70 million capital raising.
When: 3pm AEST, Tuesday 2 July 2024
Register at: https://us02web.zoom.us/webinar/register/WN_wcKESuixTf2e5TRIwVAW_Q
Upon registering attendees will receive an email containing information about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Radiopharm’s website and social media channels.
Questions can be sent in advance of the webinar to matt@nwrcommunications.com.au.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Keep reading...Show less
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