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Friday, June 3, 2022

NeuroOne Medical (NMTC) Letter to Stockholders

 NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) today announced the publication of the 2022 Annual Letter to Shareholders published in the Company's Proxy Statement for its Annual Meeting of Stockholders that occurred on May 31, 2022. The letter may be accessed here.

The letter recaps the key highlights of fiscal year 2021 and features upcoming milestones for fiscal year 2022 and beyond directed at developing the Evo® platform thin film electrode technology for patients suffering from epilepsy, chronic back pain, and Parkinson's disease.

In his letter, Dave Rosa, Chief Executive Officer of NeuroOne, states, "As we continue to develop our platform thin film electrode technology, we remain confident it will represent a transformational tool for neurosurgeons and neurologists. …. I believe we are on the right path to creating a meaningful impact in patients' lives and have been encouraged by positive feedback from physicians and patients who are excited to see our products in the market."

Highlights from Fiscal Year 2021:

  • Completed equity raise in the amount of $12.5M in January of 2021
  • Uplisted to Nasdaq in May 2021
  • Successful completion of feasibility testing of combination recording and ablation electrode
  • Partnership with RBC Medical for development of hardware for NeuroOne's ablation electrode
  • Initiated long term testing for a newly designed electrode family for treating chronic back pain due to failed back surgeries, Parkinson's disease, and epilepsy

Milestones for Fiscal Year 2022 and Beyond:

  • Re-submission to FDA for <30 day use for sEEG product line expected in August 2022
  • Complete research and development of ablation system, including the sEEG electrodes
  • Continue development of electrode for chronic stimulation
  • Build a world class management team
  • Support Zimmer Biomet in future expected launch of sEEG electrode family
  • Explore expanding new indications for chronic stimulation electrodes
  • Continue to explore complementary technology and partnerships

Adverum: New Data At the Macula Society's 2022 Annual Meeting

 Adverum Biotechnologies, Inc. announced new data from the Phase 1 OPTIC study ADVM-022 (AAV.7m8-aflibercept) development program in wet age-related macular degeneration (wet AMD) will be presented during the Macula Society's 2022 Annual Meeting in Berlin, Germany. The presentation will include an update on aflibercept protein expression data through three years post-treatment. In addition, a new analysis will compare the anatomical outcomes of a single intravitreal injection of ADVM-022 to standard-of-care bolus anti-vascular endothelial growth factor (VEGF) therapy in patients with wet AMD and will include an evaluation of the impact of baseline levels of neutralizing antibodies (NAbs) to AAV.7m8 on ADVM-022 efficacy, safety, and anatomical measures. ADVM-022 is Adverum's clinical-stage gene therapy product candidate being developed for the treatment of wet AMD. ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require a surgery to administer the gene therapy under the retina (sub-retinal approach) ADVM-022 has the advantage of being administered as a one-time IVT injection in the office and is designed to deliver long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance, and improve vision outcomes for patients with wet AMD.

https://www.marketscreener.com/quote/stock/ADVERUM-BIOTECHNOLOGIES-27535811/news/Adverum-Biotechnologies-Announces-New-Data-At-the-Macula-Society-s-2022-Annual-Meeting-40630974/

Innate Pharma Announces IPH5201 Phase 2 Study in Lung Cancer

 Innate Pharma S.A. announced that IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, will advance into a Phase 2 clinical trial in lung cancer. Innate will receive a $5 million milestone payment from AstraZeneca and will be responsible for conducting the study. AstraZeneca and Innate will share study costs and AstraZeneca will supply clinical trial drugs. AstraZeneca conducted a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (PD-L1). The data are expected to be presented at an upcoming medical meeting in due course. IPH5201 is a blocking antibody targeting the CD39 immunosuppressive pathway. CD39 is an extracellular enzyme that is expressed in the tumor microenvironment, on both tumor infiltrating cells and stromal cells in several cancer types. CD39 inhibits the immune system by degrading adenosine triphosphate (ATP) into adenosine monophosphate (AMP), that is then further degraded into adenosine by CD73. By promoting the accumulation of immune-stimulating ATP and preventing the production of immune-suppressive adenosine, the blockade of CD39 may stimulate anti-tumor activity.

https://www.marketscreener.com/quote/stock/INNATE-PHARMA-35620/news/Innate-Pharma-Announces-IPH5201-Phase-2-Study-in-Lung-Cancer-40630881/

Merck KGaA Discontinues Phase 2 Trial of Berzosertib in Combination With Topotecan

 Merck KGaA said Friday that it has discontinued a Phase 2 trial for berzosertib in combination with topotecan in patients with relapsed, platinum-resistant small-cell lung cancer.

The German pharmaceuticals and chemicals company said that, following an interim analysis, the study was discontinued due to low probability of meeting the pre-defined objective of the trial.

"SCLC remains a difficult-to-treat disease, with minimal advances in the past 20 years," Merck said, adding that it will continue external studies exploring berzosertib in additional combinations and clinical settings.

https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/Merck-KGaA-Discontinues-Phase-2-Trial-of-Berzosertib-in-Combination-With-Topotecan-40633955/

Novocure Falls 5%, Zai Lab Rises 8%; Companies Report Study Results

 Novocure Ltd. shares were down 5% to $80.59, and Zai Lab Ltd. American depositary receipts were up 8% at $30.86 after the companies reported results from a study of Tumor Treating Fields.

The EF-31 phase 2 pilot study tested Tumor Treating Fields together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) in patients with gastric adenocarcinoma, the companies said.

The study met its primary endpoint of objective response rate with "supportive signals across secondary endpoints." The companies said the "outcomes are encouraging in a historically difficult-to-treat cancer."

https://www.marketscreener.com/quote/stock/NOVOCURE-LIMITED-24157014/news/Novocure-Falls-5-Zai-Lab-Rises-8-Companies-Report-Study-Results-40635140/

CDC says it's too soon to say if monkeypox endemic in U.S

 

U.S. health officials on Friday urged doctors to test for monkeypox if they suspect cases, saying there may be community-level spread but that it was too soon to say if the disease will become endemic and that the overall public health risk remained low.

So far, there have been 21 reported cases of the disease in at least 11 states, with patients isolated to help prevent contagion, U.S. Centers for Disease Control and Prevention officials told reporters in a conference call.

https://www.marketscreener.com/news/latest/CDC-says-it-s-too-soon-to-say-if-monkeypox-endemic-in-U-S--40635143/

Novavax Crashes After FDA Suggests Its Covid Vaccine Causes Heart Inflammation

 The Food and Drug Administration suggested Friday there could be a link between Novavax's (NVAX) Covid vaccine and heart inflammation, and NVAX stock plummeted.

In briefing documents posted ahead of a critical meeting next week, the FDA said there were six cases of either myocarditis or pericarditis — heart and tissue inflammation — in recipients of Novavax's vaccine. Of those, five occurred in males, ages 16-67. There was one case in a placebo recipient.

The events suggest there could be a "causal association" between Novavax's Covid vaccine and heart inflammation, the FDA said.

In response, NVAX stock tumbled 20.4% near 44.50 in morning trades on today's stock market.

NVAX Stock: Heart Inflammation Mostly In Men

Messenger RNA-based, or mRNA, Covid vaccines from Pfizer (PFE) and Moderna (MRNA) are tied to myocarditis and pericarditis in boys and young men. For that reason, the FDA ran a supplemental analysis of those side effects.

Of the six heart inflammation cases in vaccine recipients, four occurred in males under the age of 30. A 67-year-old man and a 60-year-old woman also experienced myocarditis and pericarditis, respectively. Most events took place within 10 days of a Novavax shot — a bearish point for NVAX stock.

Only one of the events had a clear alternative explanation, as the recipient had Covid. Covid can also lead to myocarditis and pericarditis.

"Other events had only circumstantial evidence of potentially plausible alternative etiologies," the FDA said in its document. Further, "four of the events occurred in young men, a subject population known to be at higher risk of mRNA Covid-19 vaccine-associated myocarditis."

Advisory Committee Meeting Scheduled

The briefing document comes ahead of an FDA advisory committee meeting on Tuesday to discuss the Novavax Covid vaccine. A positive vote could prod NVAX stock higher. If authorized, the vaccine could offer an alternative to people concerned about the newer mRNA technology. Novavax uses DNA technology in its vaccine.

But NVAX stock has trended down since mid-December. Shares are now well below their 50-day line, according to MarketSmith.com.

The downfall comes as Novavax works to launch its vaccine broadly. Novavax's vaccine is available in Europe, Australia, Indonesia and South Korea, among other geographies. The company projects $4 billion to $5 billion in full-year sales.

https://www.investors.com/news/technology/nvax-stock-plummets-as-fda-suggests-covid-shot-linked-to-heart-inflammation/