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-Work continues- The funds will be used for the Company’s ongoing business operations, including beginning initial construction works for the first grade C lab in the Company’s Sawston, UK facility, ordering certain initial long lead-time equipment for the first grade C lab, and facility preparations for delivery of the initial GMP units of the Flaskworks system.
https://www.otcmarkets.com/filing/html?id=17505671&guid=hdQ-k6p3kt77B3h
Moderna (MRNA) Q1 2024 Earnings Call Transcript " Money Machine "
https://www.fool.com/earnings/call-transcripts/2024/05/02/moderna-mrna-q1-2024-earnings-call-transcript/
An initial launch in concert with our strategic partners in the 4th quarter of 2024 with a Neural
A definitive Merger Agreement was executed by and between Bell Buckle Holdings, Inc. RG Barron Funds Ltd. (its former control shareholder), Green Mantis LLC, Roger Hood & Reginald Kelley (new control shareholders). The agreement provides for Bell Buckle Holdings to acquire 100% of Green Mantis LLC and for the control shares of Bell Buckle Holdings to be transferred to Mr. Hood and Mr. Kelley.
https://www.greenmantisllc.com/
I would like to acknowledge the UCLA Brain Tumor Center, especially my neurosurgeon, Dr. Linda Liau for literally saving my life: https://shoutoutla.com/meet-wendy-santana-brain-tumor-awareness-advocate/
Today, we reported financial results and provided business updates for the first quarter of 2024.
Reports first quarter revenues of $167 million, GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Prepares for launches of RSV vaccine and Spikevax® 2024-2025 formula; reaffirms 2024 expected product sales of approximately $4 billion
Initiated three new clinical studies evaluating Moderna's investigational individualized neoantigen therapy in combination with Merck's Keytruda® for treatment of patients with bladder cancer, kidney cancer and cutaneous squamous cell carcinoma
Advanced three new vaccine programs (Epstein-Barr virus, Varicella-Zoster virus, norovirus) toward Phase 3 clinical trials as announced at Vaccines Day investor event
RSV: The Company anticipates initial regulatory approvals of its RSV vaccine (mRNA-1345) beginning in the first half of 2024.
Moderna is targeting fall 2024 for its U.S. RSV vaccine launch, which will build upon the success of its commercial efforts in the fall COVID-19 market. The Company is encouraged by early indications of widespread consumer awareness and established demand in the RSV market, which Moderna will enter with a strong competitive profile with robust clinical efficacy data, a well-established safety and tolerability profile for its mRNA technology, and as the only pre-filled syringe (PFS) product available.
The PFS ready-to-use formulation will save pharmacists and clinicians time, potentially alleviating wait times and reducing the burden on pharmacy staff. In a study funded by Moderna, the PFS presentation was three to four times more efficient than vaccines requiring reconstitution, measured in doses per hour and based on mean time of preparation.
Cash and Investments: Year-end cash and investments for 2024 are projected to be approximately $9 billion.
Moderna Puts Up Big Quarterly Beat; Could Shares Notch A Breakout
https://www.investors.com/news/technology/moderna-stock-moderna-earnings-q1-2024/?src=A00220
https://news.modernatx.com/news/news-details/2024/Moderna-Reports-First-Quarter-2024-Financial-Results-and-Provides-Business-Updates/default.aspx
Moderna (MRNA) earns a Zacks Rank #3 two days from its next quarterly earnings release on May 2, 2024, and its Most Accurate Estimate comes in at -$3.55 a share.
By taking the percentage difference between the -$3.55 Most Accurate Estimate and the -$3.59 Zacks Consensus Estimate, Moderna has an Earnings ESP of 0.99%.
the Company will present data from its respiratory portfolio, including vaccines and vaccine candidates against COVID-19 (mRNA-1273, mRNA-1283), influenza (mRNA-1010, mRNA-1011/1012), and respiratory syncytial virus (RSV) (mRNA-1345), along with data related to its latent virus portfolio regarding cytomegalovirus (CMV), at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Barcelona, Spain, from April 27-30, 2024.
https://investors.modernatx.com/news/news-details/2024/Moderna-To-Present-Respiratory--Cytomegalovirus-Research-at-the-ESCMID-Global-Congress/default.aspx
British patients test world’s first personalised mRNA jab for melanoma
Moderna and MSD are researching how their therapy could treat a wide range of cancers.
https://www.independent.co.uk/news/health/moderna-british-patients-bray-fat-duck-b2535073.html
Should You Buy Moderna Before May 12?
Though GSK and Pfizer both got a head start in this market, Moderna could carve out market share and eventually take a leadership position for two reasons. First, mRNA-1345 is the only one to come in a pre-filled syringe format. This makes it easier and faster for healthcare providers to administer, and results in fewer errors. All of this is a big plus for those giving the vaccine and those receiving it.
Second, in the phase 3 clinical trial of mRNA-1345, Moderna didn't observe cases of Guillain-Barre syndrome, a rare neurological disorder. But GSK and Pfizer both reported cases of this autoimmune condition in their trials. Some doctors, seeing this data, may recommend the Moderna product to their patients over others.
https://www.fool.com/investing/2024/04/26/should-you-buy-moderna-before-may-12/
Moderna CEO says AI will help scientists understand ‘most diseases’ in 3 to 5 years
https://gizmodo.com/moderna-ceo-chatgpt-employees-vaccines-openai-1851435620
Moderna and OpenAI Collaborate To Advance mRNA Medicine
At Moderna, OpenAI’s GPTs Are Changing Almost Everything
https://investors.modernatx.com/news/news-details/2024/Moderna-and-OpenAI-Collaborate-To-Advance-mRNA-Medicine/default.aspx
Anktiva is the next-generation immunotherapy drug, according to ImmunityBio executive chairman Dr. Patrick Soon-Shiong: "This drug is the first drug, as far as I know, that activates the natural killer cell that talks to the T-cell and generates complete remission..." pic.twitter.com/DIVc3A8luy
— Yahoo Finance (@YahooFinance) April 23, 2024
impatient dummies----------
Last Friday, we were honored to have Dr. Linda Liau as our 42nd Annual J. Jay Keegan Lecturer. It was an extraordinary afternoon for our residents with a phenomenal presentation and dinner to follow. We are so indebted to Dr. Liau for her time here in #Omaha. @unmc @UCLANsgy pic.twitter.com/tqb36hpn6w
— UNMC Department of Neurosurgery (@UNMC_NeuroSurg) April 22, 2024
Peter Feinberg, recently bought US$183k worth of stock, paying US$2.44 for each share
To be standing with these two giants tonight was inspiring. If I can have one tenth of the career or impact of these two, my career will be a huge success. Thank you, Dr. Liau, for visiting us here in Omaha and sharing your insight with us. @UNMC_NeuroSurg pic.twitter.com/bWtcU2TE3b
— Susan E Greni, MD, MSc (@Susan_Greni) April 20, 2024
$NWBO #DCVax: sounds like Dr. Linda Liau lecture on Friday, 4/19/2024, at the University of Nebraska Medical Center (UNMC), titled: “Immunotherapy for the treatment of Glioblastoma”, was well received. I look forward to getting more information & for Glioblastoma & other solid… https://t.co/ElCQKs8aYj pic.twitter.com/dQ6YNYDSDQ
— ATLnsider (@ATLnsider) April 20, 2024
"The DcVax-L is one of the promising immunotherapy treatments, but there are others licensed for other cancers that I can't access on the NHS because they've not got the supporting evidence from trials for brain cancer because the Conservative government at a UK level hasn't put the money into finding a cure for a cancer that is the biggest cancer killer of children and young adults.
Join us Friday, April 19, 2024 for the @UNMC_NeuroSurg 42nd Annual J. Jay Keegan Memorial Lecture as we welcome internationally renowned neurosurgeon, Dr. Linda Liau! Details below! @unmc @UNMCCOM @NebraskaMed @UCLANsgy pic.twitter.com/5ODnyI8XQs
— UNMC Department of Neurosurgery (@UNMC_NeuroSurg) April 15, 2024
This vaccine could drive growth for years if it gets approved:
Merck and Moderna split the costs and profits of the mRNA-4157 program equally, because both contributed their technology and intellectual property to the effort. In fact, it's Merck's best-selling immuno-oncology drug Keytruda that's a key component of most of the personalized cancer vaccine formulations being tested currently. Whereas mRNA-4157 aims to activate the immune system against a tumor, Keytruda protects the cells of the immune system from being hampered by some of the defenses that tumor cells often have.
So good results in the clinic for Moderna are also good results for Merck, and it looks like the pair are cooking up some more bullish results for the future too.
https://finance.yahoo.com/news/1-green-flag-moderna-merck-124500083.html
in the brain-----
Whiskey$$$$$$
IO Biotech was founded in 2014 and just 10 years into the journey we are in a pivotal phase III trial I think that’s quite fast
next catalyst-In November 2023, the company completed enrollment of 380 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in advanced melanoma. The primary endpoint of the pivotal Phase 3 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, a planned interim analysis of overall response rate (ORR) will be conducted when the first 225 randomized patients reach one year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024.
HUGE$ head and neck squamous cell carcinoma (HNSCC). Data from the study showed that treatment with the combination not only achieved positive clinical responses in HPV- HNSCC patients but even showed evidence of activation of immune responses. The combined therapy was also found to be safe and well-tolerated by study participants.
Per management, treatment with the combination achieved an objective response rate (ORR) in six out of 22 patients, including two complete responses and four partial ones. The disease control rate was 63.6%. These results were presented at the American Society of Cataract and Refractive Surgery (ASCRS) earlier this week.
Results:IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models
IMM-1-104 showed promising combination effects when treated with gemcitabine (GEM), paclitaxel (PAC) or fluorouracil (5FU) in 3D-tumor growth assay (TGA) pancreatic cancer models.
IMM-1-104 was synergistic with chemotherapy in animal models of pancreatic cancer.
In a human pancreatic cancer cell line (MIA PaCa-2) tumor xenograft model, IMM-1-104 alone showed greater tumor growth inhibition (TGI) and better durability than any single or combination chemotherapy tested.
At day 39, antitumor activity (TGI%) was 103% for IMM-1-104 at 125 mg/kg BID PO, 25.2% for GEM at 60 mg/kg IP Q4D, 62.2% for PAC at 10 mg/kg IV Q4D, and 36.6% for 5FU at 50 mg/kg IP Q4D.
In the Phase 2a portion of Immuneering’s ongoing IMM-1-104 Phase 1/2a clinical trial, IMM-1-104 is being evaluated as both monotherapy and in select combinations with approved chemotherapeutic agents. The Phase 2a portion includes five arms, three of which focus on patients with pancreatic cancer. Patients are now on treatment in multiple arms of the ongoing Phase 2a trial, including multiple patients with pancreatic cancer who are being treated with IMM-1-104 in combination with chemotherapy in the first-line setting. The company expects initial data from multiple Phase 2a arms in 2024.
https://ir.immuneering.com/news-releases/news-release-details/imm-1-104-synergistic-chemotherapy-pancreatic-cancer-models
Not only was the combination found to be safe, researchers found evidence that it activated immune responses
https://s29.q4cdn.com/435878511/files/doc_presentations/2024/Apr/08/12091203_aacr2024_bauman_poster_159-76x94-76_v22_final-61.pdf
vaccine shows benefit in head and neck cancer in early study
Data from 22 patients who received the vaccine, mRNA-4157, in combination with Keytruda was reported at the American Association for Cancer Research Annual Meeting at San Diego on Monday.
The vaccine combination showed evidence of activation of immune responses in patients, and was found to be safe and well tolerated in the study, Moderna said.
We can see that institutions own the lion's share in the company with 68% ownership
Dr Olive added: 'I’ve been working on pancreatic cancer for almost 20 years, and I’ve never seen preclinical results like these.
'I think there is a real chance this approach will help change the standard of care for pancreatic cancer patients, but only clinical trials can determine that
Breakthrough in fight against world's deadliest cancer - new drug shrunk up to 70% of pancreatic tumors in lab study
https://www.dailymail.co.uk/health/article-13284461/pancreatic-cancer-breakthrough-deadliest-disease-study.html
next catalyst -The PDUFA (Prescription Drug User Fee Act) action date for mRNA-1345 is May 12, 2024
Cancer vaccines----- towards a new future
https://www.nature.com/collections/dfajababaj
Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial
https://www.nature.com/articles/s41591-024-02894-y
Novocure Announces 20 Presentations On Tumor Treating Fields, Highlighting Preclinical Effects in Pancreatic Cancer and Immune Effects, at American Association for Cancer Research (AACR) Annual Meeting 2024
https://www.biospace.com/article/releases/novocure-announces-20-presentations-on-tumor-treating-fields-highlighting-preclinical-effects-in-pancreatic-cancer-and-immune-effects-at-american-association-for-cancer-research-aacr-annual-meeting-2024/
In this article, Drs. Robert Prins, Won Kim @inspired_brain, Linda Liau, Richard Everson, & colleagues identified distinct alterations in the immune landscapes of the tumor microenvironments in #metastatic brain cancer & recurrent #glioblastoma. Read more: https://t.co/RgEBXnbIax pic.twitter.com/mbZMAu9kGd
— UCLA Neurosurgery 🧠 (@UCLANsgy) April 6, 2024