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Radiopharm Theranostics ‘Extends Runway’ to Key Milestones with AU$70M Investments: Report
July 31, 2024
Description
The AU$7.5 million strategic investment from Lanthues Holdings signals a strong endorsement of Radiopharm Theranostics’ (ASX:RAD) technology, extending the company's runway to key milestones, according to a new report from Diamond Equity Research.
The anticipated acceleration in growth from the capital infusion and asset development synergy underscores the strategic significance of this partnership.
“This collaboration is pivotal, as Lantheus's expertise and established market presence in key regions, such as the US, Canada and Europe, significantly enhance the strategic value of their investment in Radiopharm,” the report said.
Under the agreement Lantheus will make an initial strategic equity investment of AU$7.5 million. Lantheus has an option to invest an additional AU$7.5 million within the next six months under the same terms. In addition, will transfer two early preclinical assets to Lantheus for AU$3 million. These assets include a TROP2 targeting nanobody and a LRRC15 targeting mAb.
“The anticipated acceleration in growth from the capital infusion and asset development synergy further underscores the strategic significance of this partnership.”
Highlights of the report:
- Strategic investment by and asset transfer agreement with Lantheus Holdings mark a significant enhancement in Radiopharm's growth strategy and capital strength
- Radiopharm has secured firm commitments from institutional and sophisticated investors for a significant capital increase through another placement totaling A$62.5 million.
- Radiopharm Theranostics is positioned in the growing radiopharmaceutical market, which is projected to reach $9.67 billion by 2026. The company's diversified portfolio targets various cancers, including prostate, breast, renal cell carcinoma, and lung cancer.
For the full analyst report, click here.
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RAD:AU
5h
Quarterly Activities Report
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 30 June 2024.
Corporate activities
BP8 ended the quarter with cash of approximately $0.132 million ($0.257 million at 31 March 2024).
At the Company’s general meeting convened on 24 May 2024 (General Meeting), the Company obtained 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 progress with the proposed share placement will be released to the market in due course.
Also at the General Meeting, shareholders approved a consolidation of the Company’s share capital on the basis of one (1) security for every five (5) securities in the Company’s then unconsolidated share capital.
Total aggregate cash payments of $4,000 were made during the quarter to related parties and their associates as remuneration. Details of these payments are included in items 6.1 and 6.2 of the Appendix 4C.
120-day business development plan
On 20 March 2024 the Company announced that it was undertaking a new 120-day business development plan from March through June 2024. The announcement coincided with an extensive visit by the Company’s CEO Matthew Leonard and CFO Chow Yee Koh to Malaysia and China for a series of meetings over a 2–3-week period. The CEO and CFO were joined by China-based Company Director Michael Huang for those strategic meetings in Malaysia and China. The Company’s CEO and executive Director Frank Cannavo have subsequently visited South Asia and Hong Kong to further progress the business development plan objectives.
Click here for the full ASX Release
This article includes content from BPH Global, 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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21h
BPH Global Raises $130,000 in Debt Funding
BPH Global Limited (Company) announces that the Company has entered into loan agreements to raise $130,000 to provide short term funding to the Company pending completion of its proposed capital raising of up to $1,000,000. The proposed capital raising was approved by shareholders at a general meeting held on 24 May 2024.
Pursuant to the loan agreements, the four directors of the Company will each provide loan funding of $25,000 to the Company and a non-related party will provide an additional $30,000. The funds raised will be used for working capital purposes.
Click here for the full ASX Release
This article includes content from BPH Global, 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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31 July
Quarterly Activities/Appendix 4C Cash Flow Report
Sydney, Australia – 31 July 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, is pleased to provide a summary of its activities for the quarter ended 30 June 2024.
HIGHLIGHTS
- A$70 million Placement completed, including strategic investment from major global radiopharmaceutical company Lantheus Holdings
- Funds to be allocated primarily towards drug manufacturing and advancing clinical trials
- Post end of period, the first patient is dosed in the Phase 1 therapeutic trial of RAD 204
- Radiopharm advancements showcased at‘Oncology/Cell Tx Innovation: The Texas Trifecta’ event in April
- Radiopharm featured at multiple B. Riley Securities Healthcare events
- FDA IND approval for Phase 2b imaging trial in brain metastases
RADIOPHARM THERANOSTICS COMPLETES A$70 MILLION PLACEMENT, INCLUDING A STRATEGIC INVESTMENT FROM LANTHEUS HOLDINGS
Late in the quarter Radiopharm announced the successful completion of a A$70 million placement (Placement), marking a pivotal milestone for the company. The Placement included a strategic investment from Lantheus Holdings, Inc., a leader in the global radiopharmaceutical industry. Lantheus committed A$7.5 million at a price of A$0.05 per share. Additionally, Lantheus holds an option to further invest another A$7.5 million within the next six months.
As part of the agreement Lantheus also secured rights to two early preclinical assets through a A$3 million upfront payment.
The Placement will raise an additional A$62.5 million, with the new shares offered at A$0.04 each, representing an 18% premium to the closing price prior to the Placement announcement. This fundraising effort attracted participation from leading international institutional investors, including specialist healthcare investors from the US. The Placement is expected to fully support Radiopharm’s current clinical programs until 2026, ensuring a robust pipeline of development.
Executive Chair Paul Hopper is also participating in the Placement with a personal investment of A$3 million, pending shareholder approval. Led by Paul’s A$3 million, the other directors have also invested in the placement subject to shareholder approval.
The proceeds from this capital raise will be allocated primarily towards drug manufacturing, advancing clinical trials, general working capital, and covering the costs associated with the capital raising.
An Extraordinary General Meeting (EGM) is scheduled to be held on 14 August 2024 to seek shareholder approval for the Placement and the issuance of additional options.
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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26 July
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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23 July
Radiopharm Theranostics Receives FDA IND Approval for Phase 2b Imaging Trial in Brain Metastases
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 it has received clearance for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA), for F18-Pivalate (RAD 101).
Pivalate, labelled with the radioisotope F18, is a small molecule that selectively targets fatty acid synthetase, which is overexpressed in brain tumours but not in normal cells. Pivalate is a novel proprietary imaging agent under clinical investigation for the detection and characterisation of brain metastases.
The IND approval is a clear recognition by the FDA of clinical data already generated for RAD 101 and is a significant milestone towards starting a Phase 2b multi-center trial for the imaging of brain metastases. Radiopharm anticipates having the first patient dosed during the fourth quarter of 2024. Based on current enrolment expectations, the 30-patient Phase 2b read-out is expected by mid-2025 and will be followed by a Phase 3 registrational study.
Previously reported positive data from the Imperial College of London’s Phase 2a imaging trial of Pivalate in 17 patients with brain metastases showed significant tumour uptake that was consistent with and independent from the tumour of origin¹. This supports the potential use of pivalate to monitor brain metastases.
“Pivalate represents a potential new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients and the medical community an alternative to overcome the limitations of current standard of care for imaging brain metastasis.” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are very pleased by this FDA approval as it allows us to commence late-stage clinical studies and address the high unmet medical need in around 300,000 patients that are diagnosed with brain metastases in the U.S. every year.”
Radiopharm holds an exclusive global license for the pivalate platform technology and has a collaboration in place with Imperial College of London to develop a therapeutic candidate leveraging the same mechanism of action.
¹ S. Islam, M. Inglese, P. Aravind, A. Waldman, M. Williams, E.O. Aboagye. 18F-Fluoropivalate PET/MRI: imaging of treatment naïve patients and patients treated with radiosurgery [Poster #135]. 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, October 26 2022.
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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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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