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![FSD Pharma Signs Agreement With Ingenu CRO to Conduct a Clinical Trial To Determine the Safety and Efficacy Effects of its Proprietary Blend Beverage unbuzzd(TM)](https://investingnews.com/media-library/image.png?id=51566584&width=1200&height=800)
FSD Pharma Signs Agreement With Ingenu CRO to Conduct a Clinical Trial To Determine the Safety and Efficacy Effects of its Proprietary Blend Beverage unbuzzd(TM)
FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announced that through its subsidiary, HUGE Biopharma Australia Pty Ltd., it entered into an agreement with Ingenu CRO Pty Ltd on February 19, 2024 to conduct "A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Safety and Efficacy of unbuzzd™ in Healthy Volunteers in an Induced State of Alcohol Intoxication (METAL-1 TRIAL)".
This trial is an important step to further verify that the effects of drinking unbuzzd™ helps a person sober up faster from the effects of alcohol. FSD Pharma's proprietary dietary supplement product is called unbuzzd™. unbuzzd™ is a fortified oral liquid formula that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism, and may accelerate the rate of alcohol metabolism in the body allowing a person to sober up faster. Celly Nutrition Corp. ("Celly Nu"), led by beverage and marketing icons Gerry David, former CEO of Celsius, John Duffy former executive of Coca Cola and Kevin Harrington formerly on Shark Tank. Celly Nu is the holder of exclusive rights to FSD Pharma's technology for the recreational sale and use market. Separately FSD Pharma continues to develop a medical based product to accelerate the rate of alcohol metabolism for use in hospitals, medical centres and for front line workers.
"Our R&D team has worked tirelessly over the past year to accumulate science-based information to design the unbuzzd™ recreational alcohol use formulation. This clinical trial is an important next step to delivering science-based evidence to confirm what we believe we have discovered - a discovery which could potentially change the rate at which we metabolize alcohol in the body, or in simple terms sober up faster" said Mr. Zeeshan Saeed, CEO and co-founder of FSD Pharma.
About FSD Pharma
FSD Pharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly-owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), FSD is focused on the research and development of its lead compound, Lucid-MS (formerly Lucid-21-302) ("Lucid-MS"). Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. FSD Pharma has also licensed unbuzzd™, a proprietary formulation of natural ingredients, vitamins, and minerals to help with liver and brain function for the purposes of quickly relieving individuals from the effects of alcohol consumption for use in the consumer recreational sector, to Celly Nutrition Corp. ("Celly Nu") and is entitled to a royalty on the revenue generated by Celly Nu from sales of products created using the technology rights granted under the licensing agreement. FSD Pharma continues its R&D activities to develop novel formulations for alcohol misuse disorders and continues the development of such treatments for use in the healthcare sector. FSD maintains a portfolio of strategic investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property.
Cautionary Note Regarding Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements") within the meaning of applicable securities laws. Any statements that are contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as "plans", "expects", "expected", "scheduled", "estimates", "intends", "anticipates", "hopes", "planned" or "believes", or variations of such words and phrases, or states that certain actions, events or results "may", "could", "would", "might", "potentially" or "will" be taken, occur or be achieved. More particularly, and without limitation, this press release contains forward-looking statements contained in this press release include statements concerning the future of FSD Pharma and are based on certain assumptions that FSD Pharma has made in respect thereof as of the date of this press release, including those relating to future sales of Class B Shares under the ATM Offering, the offering price therefor and the use of proceeds thereof. FSD Pharma cannot give any assurance that such forward-looking statements will prove to have been correct.
Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it believes the expectations and material factors and assumptions reflected in these forward-looking statements are reasonable as of the date hereof, there can be no assurance that these expectations, factors and assumptions will prove to be correct and these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to a number of known and unknown risks and uncertainties including, but not limited to: the timing and ability to satisfy all applicable listing and regulatory requirements of the CSE and Nasdaq; the fact that the drug development efforts of the Company and Lucid are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company and Lucid may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company and Lucid; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company and Lucid; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company and Lucid; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company and Lucid; the inability of the Company to sell under the ATM Offering or upon the terms outlined herein; the prices at which the Company may sell the Class B Shares in the ATM Offering; and other risks. Accordingly, readers should not place undue reliance on the forward-looking statements contained in this press release, which speak only as of the date of this press release.
Further information regarding factors that may cause actual results to differ materially are included in the Company's annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR+ (www.sedarplus.ca) and with the SEC on EDGAR (www.sec.gov), including the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2022, the Prospectus and Registration Statement, each under the heading "Risk Factors". This list of risk factors should not be construed as exhaustive. Readers are cautioned that events or circumstances could cause results to differ materially from those predicted, forecasted or projected. The forward-looking statements contained in this document speak only as of the date of this document. FSD Pharma does not undertake any obligation to publicly update or revise any forward-looking statements or information contained herein, except as required by applicable laws. The forward-looking statements contained in this document are expressly qualified by this cautionary statement.
Neither the CSE nor its regulation services provider accept responsibility for the adequacy or accuracy of this release.
Contacts:
FSD Pharma Inc.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board, FSD Pharma Inc.
Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8884
Investor Relations
Email: ir@fsdpharma.com, info@fsdpharma.com
Website: www.fsdpharma.com
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.
Oncology Stocks: 8 Biggest NASDAQ Companies in 2024
The wide-ranging oncology market covers every area of cancer care, from diagnosis to treatment.
Coming in only after cardiovascular disease, cancer is the second leading cause of death worldwide; unsurprisingly, oncology is one of the biggest sectors in the life science space. With that in mind, biotechnology and pharmaceutical companies alike are working to develop best-in-class therapeutics for the treatment of various cancers, including lung, breast and prostate cancer.
At this point, their work is far from finished — Fortune Business Insights projects that the global oncology market will increase at a compound annual growth rate of 11.3 percent to reach US$518.25 billion in 2032.
As the global oncology market grows, investors who want exposure to companies working to treat cancer should consider taking a look at biotech and pharma companies with a focus on oncology drugs and testing.
This list of the biggest oncology stocks on the NASDAQ was generated using TradingViews's stock screener. The companies are listed in order of market cap, and all figures below were current as of June 19, 2024.
1. AstraZeneca (NASDAQ:AZN)
Market cap: US$244.56 billion; current share price: US$78.42
First on this list of the top NASDAQ oncology companies by market cap is multinational pharma and biotech firm AstraZeneca, which also specializes in several other therapeutic areas, including cardiovascular, respiratory, central nervous system and pain control. The company is aiming to strengthen its position in the oncology market by more than doubling its cancer drug offerings by 2030.
AstraZeneca has several partnerships with other pharma companies, including Merck (NYSE:MRK). The pair brought PARP-inhibitor LYNPARZA to market as a monotherapy and in combination to address multiple cancer types, including in certain breast, prostate, pancreatic and ovarian tumors. The drug’s revenues for these indications are expected to reach US$4 billion by 2027, representing more than 68 percent of the projected global PARP inhibitors market for that year.
2. Amgen (NASDAQ:AMGN)
Market cap: US$164.14 billion; current share price: US$305.99
One of the world's leading independent biotechnology companies, Amgen uses advanced human genetics to develop and manufacture therapeutics targeting oncological diseases, including a range of solid tumors and hematologic malignancies.
Amgen is advancing a robust pipeline with several mid- to late-stage candidates, including drug candidates targeting leukemia, colorectal cancer and solid tumors. Amgen's oncology portfolio includes first-in-class Bispecific T-cell Engager (BiTE) therapy Blincyto, which in June received US Food and Drug Administration (FDA) approval for the treatment of adult and pediatric patients with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase.
This is the second BiTE therapy from Amgen to gain FDA approval. The company's Imdelltra (tarlatamab) got the nod in May for treating adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
3. Sanofi (NASDAQ:SNY)
Market cap: US$119.61 billion; current share price: US$47.22
Based in France, Sanofi is developing new technologies based on molecular oncology, immuno-oncology and genomic medicine platforms targeting some of the most difficult-to-treat cancers. The company's oncology strategy encompasses four disease areas: blood cancers, including multiple myeloma; skin cancers; lung cancers; and breast cancer and other hormone-positive cancers.
Sanofi's oncology pipeline includes 13 drug candidates in clinical development, with a focus on solid tumors, leukemia, and myeloma. In June, the company shared positive data from its Phase 3 IMROZ regimen study of Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd. The results demonstrated a significant reduction in the risk of disease progression or death by 40 percent when compared to VRd followed by Rd alone.
4. Regeneron Pharmaceuticals (NASDAQ:REGN)
Market cap: US$114.48 billion; current share price: US$1,039.11
Biotech leader Regeneron Pharmaceuticals develops and commercializes medicines targeting cancer, pain and a wide variety of diseases, including inflammatory, cardiovascular, metabolic, hematologic and rare diseases.
The company’s drug candidate portfolio includes 18 clinical-stage programs targeting various cancers, including solid tumors, prostate cancer, cervical cancer and metastatic melanoma. Its 12 FDA approved drugs include Libtayo (cemiplimab-rwlc) for cutaneous squamous cell carcinoma, basal cell carcinoma and non-small cell lung cancer.
In an effort to expand its cell therapy research, Regeneron acquired biotech 2Seventy Bio’s (NASDAQ:TSVT) cancer drug pipeline earlier this year.
“Our expertise in antibody technologies and emerging genetics capabilities, combined with 2seventy’s cell therapy platforms, presents a significant opportunity to address cancer and other serious diseases in new and impactful ways,” said George Yancopoulos, Regeneron’s chief scientific officer, in a statement.
5. Gilead Sciences (NASDAQ:GILD)
Market cap: US$78.68 billion; current share price: US$63.15
Global biopharmaceutical company Gilead Sciences is in the business of developing breakthrough medicines to prevent and treat serious conditions such as HIV, viral hepatitis and cancer. Last year, the company built up its early oncology pipeline with the acquisition of biotech firm XinThera and its portfolio of small molecule inhibitors targeting PARP1.
One of Gilead's biggest successes is Yescarta, a CAR-T cell therapy for blood cancer and the first such therapy for certain types of non-Hodgkin's lymphoma. Earlier this year, Reuters reported that improvements in its manufacturing process will allow the company "to quadruple production of its cell therapy cancer treatments by 2026."
6. Moderna (NASDAQ:MRNA)
Market cap: US$51.05 billion; current share price: US$133.27
Moderna is a leader in applied mRNA science with a diverse clinical portfolio of vaccines and therapeutics. Its mRNA platform harnesses the body's immune system to identify and kill cancer cells, including individualized mRNA-based personalized cancer vaccines.
In June, Moderna and Merck released positive three-year data from a clinical study evaluating the use of an experimental vaccine in combination with Merck's FDA-approved Keytruda in the treatment of melanoma, the most deadly form of skin cancer. The data showed improved survival rates and long-lasting efficacy.
7. BioNTech (NASDAQ:BNTX)
Market cap: US$20.51 billion; current share price: US$86.27
Biopharma BioNTech is advancing immunotherapies for serious diseases, including various forms of cancer. The company’s oncology portfolio includes mRNA-based therapies, CAR-T cell therapies and targeted cancer antibodies.
BioNTech has a collaboration deal with China-based biotech company Duality Biologics to develop, manufacture and license multiple antibody-drug conjugate candidates targeting solid tumors. Early this year, the FDA granted fast track designation for one of them, the candidate BNT325/DB-1305 for the treatment of platinum-resistant ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer in patients who have previously received one to three systemic treatment regimens.
However, in mid-June the FDA placed a partial hold on the Phase 1 trial for the candidate after BioNTech disclosed the deaths of three patients due to “treatment-related adverse effects.” The partial hold prevents the enrollment of any new US patients in the study.
“The fact that patients already enrolled in the Phase I BNT326/YL202 study will continue to receive the drug suggested that the FDA’s concerns were manageable,” commented John Newman, PhD, a senior biotechnology analyst with Canaccord Genuity.
8. Illumina (NASDAQ:ILMN)
Market cap: US$17.22 billion; current share price: US$108.10
Illumina develops, manufactures and markets life science tools and integrated systems that enable the implementation of genomic solutions for the healthcare sector with a focus on oncology testing, genetic disease testing, reproductive health and research. The company is expanding its next-generation sequencing oncology portfolio to help clinical cancer researchers estimate tumor mutational burden, identify neoantigens and study innovative therapies to boost the immune response.
In January, Illumina announced an expansion of its collaboration with Janssen Research & Development for the development of the latter's novel molecular residual disease assay. The assay is based on using whole-genome sequencing for multi-cancer research for the detection of circulating tumor DNA. The purpose is to better understand how oncological diseases can persist reoccur following treatment, and it will look at samples "from patients previously diagnosed with cancer across multiple solid tumor indications," according to the release.
This is an updated version of an article first published by the Investing News Network in 2018.
Don’t forget to follow us @INN_LifeScience for real-time updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Radiopharm Theranostics Limited (ASX: RAD) – Reinstatement to Quotation
Description
The suspension of trading in the securities of Radiopharm Theranostics Limited (‘RAD’) will be lifted immediately following the release by RAD of an announcement regarding its capital raising.
ASX Compliance
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.
Radiopharm Theranostics Completes A$70 Million Placement
Radiopharm Theranostics Limited (ASX:RAD), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, has received firm commitments to raise approximately A$70.0 million (before costs) by way of a placement (the Placement) comprised of international and Australian institutional and industry investors, including Lantheus Holdings (“Lantheus”) and specialist US healthcare investors.
- Radiopharmaceutical industry leader, Lantheus Holdings, Inc., has agreed to make an initial strategic equity investment of A$7.5m at A$0.05 per share, which represents a 47% premium to last closing price of A$0.034 on 19 June 2024
- Two Tranche Placement to raise an additional A$62.5m, taking total amount raised under the placement to A$70.0m
- Offer price for shares issued under the balance of the placement of A$0.04 represents an 18% premium to the last closing price
- Participation from leading international institutional investors including US specialist healthcare investors
- Net proceeds are expected to fully fund the current clinical programs until the end of 2026
- Executive Chair, Paul Hopper, to participate in the placement with A$3.0 million investment, subject to shareholder approval
- Option for Lantheus to invest a further A$7.5m within 6 months on the same terms
- Lantheus will also secure rights to two early preclinical assets in exchange for an A$3m upfront payment pursuant to a transfer and development agreement
As part of the Placement, as announced on 20 June 2024 and subject to shareholder approval, Lantheus has subscribed for:
- a) A$7.5 million (US$4.99 million) at A$0.05 (US$0.033) per share;
- b) unlisted options with a six-month term after the date the subscription shares are issued to invest up to an additional A$7.5 million (US$5 million) at A$0.05 (US$0.033) per share; and
- c) one option for every four shares subscribed for (inclusive of any shares further subscribed for in the next six months), exercisable at A$0.06 per option expiring in August 2026, (together, “Lantheus Interests”).
Riccardo Canevari, Radiopharm’s Chief Executive Officer & Managing Director, said “We are delighted to complete this significant capital raise which will allow us to accelerate the development of our portfolio, as well as provide an expected cash runway to the end of 2026. To have attracted investment from Lantheus, one of the radiopharmaceutical industry’s leading companies, is a solid endorsement of RAD’s potential. We look forward to working closely with Lantheus in the coming years.”
As announced on 20 June 2024, and separate to the Placement, under a separate transfer and development agreement, RAD has agreed to assign and sub-license two of its preclinical assets to Lantheus for A$3.0 million (US$2.0 million). Assets covered under the agreement are a TROP2 targeting nanobody and a LRRC15 targeting mAb.
“We are pleased to make a strategic investment in RAD and partner with them to further expand our innovative pipeline,” said Brian Markison, Chief Executive Officer of Lantheus. “Radiopharmaceutical theranostics are changing the way cancer is diagnosed and treated, yet we still have more work to do and are inspired to further advance this field with these two preclinical oncology assets.”
An Extraordinary General Meeting (“EGM”) to approve the Lantheus Interests, second tranche component of the Placement (as described further below), and all options offered under the capital raising is anticipated to be held in early August 2024.
Bell Potter Securities Limited acted as lead manager to the capital raising and B. Riley Securities Inc acted as US placement agent. B. Riley Securities is acting as financial advisor to the Company on the Lantheus transactions.
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.
Radiopharm Receives Strategic Investment for up to A$18 million
Radiopharm Theranostics Limited (ASX:RAD) (Radiopharm or the Company), a developer of diagnostic and therapeutic radiopharmaceutical products, has entered into strategic agreements with Lantheus Holdings, Inc. (LNTH.NASDAQ), a leading radiopharmaceutical-focused company, and its affiliates (Lantheus). Lantheus has agreed to make an initial equity investment of A$7.5 million (US$4.99 million) and will have an option to invest a further A$7.5 million (US$5 million) within 6 months on the same terms. Additionally, Radiopharm has agreed to transfer two of its early preclinical assets to Lantheus for A$3.0 million (US$2.0 million) pursuant to a separate transfer and development agreement.
- Lantheus has agreed to make an initial strategic equity investment of A$7.5 million in Radiopharm
- Offer price for the shares of A$0.05 represents a 47% premium to the last closing price of $0.034 on 19 June 2024
- Option for Lantheus to invest a further A$7.5m within 6 months on the same terms
- Lantheus will also secure rights to two early preclinical assets in exchange for an A$3m upfront payment pursuant to a transfer and development agreement
Subject to shareholder approval for the purposes of ASX Listing Rule 7.1, under a subscription agreement entered into with Radiopharm (Subscription Agreement), Lantheus has subscribed for up to:
a) A$7.5 million (US$4.99 million) at A$0.05 (US$0.033) per share;
b) unlisted options with a six-month term after the date the subscription shares are issued to invest up to an additional A$7.5 million (US$5 million) at A$0.05 (US$0.033) per share; and
c) one option for every four shares subscribed for (inclusive of any shares further subscribed for in the next six months), exercisable at A$0.06 per option expiring in August 2026.
Under a separate transfer and development agreement, Radiopharm has assigned and sub- licensed two of its preclinical assets to Lantheus for A$3.0 million (US$2.0 million). Assets covered under the agreement are a TROP2 targeting nanobody and a LRRC15 targeting mAb.
B. Riley Securities is acting as financial advisor to the Company on the Lantheus transactions.
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.
Radiopharm Theranostics Limited (ASX: RAD) – Trading Halt
Description
The securities of Radiopharm Theranostics Limited (‘RAD’) will be placed in trading halt at the request of RAD, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Monday, 24 June 2024 or when the announcement is released to the market.
ASX Compliance
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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