Media & Technology
Big Rock Partners Acquisition Corp (NASDAQ: BRPA) SPAC Heats Up as NeuroRx. (NRXP) Reports ZYESAMI™ Met Primary Endpoint in its Covid-19 Phase 2b/3 Trial
Big Rock Partners Acquisition Corp (NASDAQ: BRPA) is making an explosive move up the charts after its coming merger partner NeuroRx reported ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site. This is big news for BRPA which took off in December after the Company initially announced the merger with NeuroRx. Under the terms of the transaction, Big Rock and NeuroRx will merge and the company is expected to continue to trade on the Nasdaq Stock Market under the symbol “NRXP.” The transaction is expected to occur in the first or second quarter of 2021.
In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007). ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA).
Big Rock Partners Acquisition Corp (NASDAQ: BRPA) is a blank check company formed pursuant to the laws of the State of Delaware on September 18, 2017 for the purpose of entering into a merger, stock exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities. BRPA is a clean shell with $32,005,205 held in cash and marketable securities held in money market funds, which are invested in U.S. Treasury securities. During 2020 BRPA reported $1.2 million in interest income and $400k in net income.
BRPA skyrocketed off its $10 base in December to a high of $76.99 per share after the Company reported it was merging with NeuroRx, Inc. currently developing the covid therapeutic (RLF-100 or “ZYESAMI™ (aviptadil)”). Under the terms of the transaction, Big Rock and NeuroRx will merge and the company is expected to continue to trade on the Nasdaq Stock Market under the symbol “NRXP.” The transaction is expected to occur in the first or second quarter of 2021.
An Innovator in Mental Health and Respiratory Drug Development; NeuroRx is a clinical stage, small molecule pharmaceutical company which develops novel therapeutics for the treatment of central nervous system disorders and life-threatening pulmonary disease. NeuroRx’s two main drugs are “ZYESAMI™ (aviptadil)” which is an application for COVID-related respiratory failure and “NRX-101”, which focuses on suicidal bipolar depression and PTSD. ZYESAMI is a synthetic human Vasoactive Intestinal Peptide (VIP), a 28 amino-acid natural peptide with 50 years of research evidence led by the late Prof. Sami Said, documenting protection from Lung Injury by protecting type II epithelial cells. NRX-101 is a fixed-dose combination of D-cycloserine and lurasidone that has advanced to phase 3 with FDA Breakthrough Therapy Designation, a Special Protocol Agreement, Biomarker Letter of Support, and Fast Track Designation. NRX-100/101 is being developed based on Prof. Daniel Javitt’s (Chair of NeuroRx’s Scientific Advisory Board) patented discovery that drugs targeting both the NMDA and 5-HT2A receptors in the brain have the potential to treat both depression and suicidality without the hallucinations caused by most NMDA inhibitors and without the potential for suicide attributable to other 5-HT2A inhibitor drugs.
NeuroRx’s management team is comprised of seasoned industry veterans, led by Founder, Chairman & CEO Jonathan C. Javitt, MD, MPH, Robert Besthof, MIM (Chief Commercial Officer), William Fricker, MBA, CPA (Chief Financial Officer) and Alessandra Daigneault, JD (Corporate Secretary), who are expected to continue to run the combined company, post-transaction.
BRPA is once again on fire after NeuroRx reported ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.
In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007).
To the company’s knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA).
Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance. The above analysis includes all 196 participants who were randomized and treated in the placebo-controlled, double-blind clinical trial (www.clinicaltrials.gov NCT04311697) conducted at 10 US hospitals. Treatment with ZYESAMI™ or placebo was in addition to standard of care treatment that included steroids, convalescent plasma, antiviral therapy, anticoagulants, and various anti-cytokine drugs.
$BRPA MORE VOLUME COMING IN 🚨
— The Stock Trader Hub (@StockTraderHub) March 29, 2021
https://twitter.com/StarvinMargin/status/1376450708472467458
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NeuroRx has announced the commencement of a clinical trial of inhaled ZYESAMI™ for the treatment of patients with moderate and severe COVID-19 with the aim of preventing progression to respiratory failure. NeuroRx has also announced the inclusion of inhaled ZYESAMI™ in the I-SPY clinical trial platform for patients with COVID-19 respiratory failure. The company has signed a clinical trial participation agreement with the National Institutes of Health.
The study’s coordinating committee, including Professors Dushyantha Jayaweera, MD, FACP (University of Miami), Richard Lee, MD, (UC Irvine), and J. Georges Youssef, MD (Houston Methodist Hospital) commented, “The 60-day observation framework implemented last month by FDA for critically ill patients with COVID-19 is more consistent with the clinical course of this lethal disease than the 28-day time frame originally adapted from other conditions that cause respiratory distress. The association of baseline oxygenation status (high flow nasal oxygen vs. ventilation) is not surprising in that patients who require mechanical or noninvasive ventilation in order to maintain blood oxygen are likely to have substantially more damage to the lining of their lungs compared to patients whose blood oxygen level can be maintained with high-flow oxygen delivered to the nose. The finding that patients fared substantially better in tertiary care centers as compared to regional hospitals may be influenced by the intensity of the public health crisis at the regional hospitals that participated in the study, all of which were operating at 200% or higher overcapacity in their intensive care units with implementation of temporary ICU beds and shortages of critical care staff.”
Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, said, “ZYESAMI has now demonstrated itself in a phase 2/3 trial, conducted under FDA Fast Track Designation, not only to shorten hospitalization (as was previously reported) but also to save lives and increase the likelihood of patients returning safely home to their families. In exactly 12 months, a lifesaving drug has advanced from concept to clinical success in partnership with Relief Therapeutics in the midst of a public health emergency that has claimed the lives of millions. Today’s findings confirm the often-dramatic clinical success that has been seen in numerous patients treated in the US and abroad under emergency use protocols. We look forward to working with the National Institutes of Health, the Department of Defense, the FDA, and regulators around the world to bring this treatment to patients as quickly as possible.”
https://twitter.com/BuIIsClub/status/1376452149098463232
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Big Rock Partners Acquisition Corp (NASDAQ: BRPA) is making an explosive move up the charts after its coming merger partner NeuroRx reported ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site. This is big news for BRPA which took off in December after the Company initially announced the merger with NeuroRx. Under the terms of the transaction, Big Rock and NeuroRx will merge and the company is expected to continue to trade on the Nasdaq Stock Market under the symbol “NRXP.” The transaction is expected to occur in the first or second quarter of 2021. In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007). ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial. On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration (“FDA”) for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA). We will be updating on BRPA on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with BRPA.
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Disclosure: we hold no position in BRPA either long or short and we have not been compensated for this article.
Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news. The United States Patent and Trademark Office has granted them a notice of allowance for their patent application concerning a groundbreaking chemical compound called EB-373. This compound is being developed to address the treatment of anxiety disorders.
The forthcoming patent, titled “C4-Carbonothioate-Substituted Tryptamine Derivatives and Methods of Using,” encompasses claims for the composition of matter of a family of revolutionary prodrug derivatives of psilocin. Enveric’s lead product candidate, EB-373, stands out among these derivatives. A Notice of Allowance signifies that the USPTO has determined that a patent should be granted based on the submitted application.
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$ENVB halted up
— Antonio Costa (@ACInvestorBlog) May 18, 2023
Enveric’s commitment to innovation extends beyond EB-373. They have also submitted additional patent applications to the USPTO, exploring psilocin prodrugs with unique crystalline molecular structures. Moreover, they have taken proactive steps to pursue global coverage of the EVM201 and EVM301 Series through companion Patent Cooperation Treaty and non-US national patent applications. Encouragingly, positive International Search Reports and written opinions have been received under the Patent Cooperation Treaty for most of these applications.
$ENVB 💰💰💰💰💰 pic.twitter.com/qCIxiCpF0E
— FonsieTrader (@FonsieTrader) May 18, 2023
Joseph Tucker, Ph.D., Enveric’s director and CEO, underlined the significance of the USPTO’s favorable decision concerning their lead candidate, EB-373. He highlighted the innovative designs of their psilocin prodrugs within the EVM201 series, differentiating them from conventional counterparts like psilocybin. These novel designs hold the potential to deliver more rapid therapeutic effects, precise control, and reduced gastrointestinal side effects. Tucker emphasized that securing a robust intellectual property portfolio for their new chemical entity prodrugs is pivotal to Enveric’s value proposition and integral to their business strategy of developing cutting-edge small-molecule therapeutics to address mental health disorders.
$ENVB 👇this is an important milestone for the company! The price could increase fivefold wit the time imo.
Enveric Biosciences Receives Notice Of Allowance From US Patent And Trademark Office For Novel Prodrug Of Psilocin
— Swingy John (@daytrader_2020) May 18, 2023
We will update you on ENVB when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!
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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.
Image by Gino Crescoli from Pixabay
TScan to Receive $30 Million Upfront With Potential Development and Commercial Milestone Payments of Over $500 Million.
Collaboration Brings Together TScan’s Proprietary Target Discovery Platform and Amgen’s Inflammation Therapeutic Expertise and Research Capabilities
Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn’s disease.
All things considered, this is among one of the largest deals you’ll see for a micro-cap biopharma company. As many of you know, companies in this sector of this size and scale are typically not profitable – mainly focusing on R&D until their drug or technology is fully approved/commercially viable.
The critical thing to note with this deal between TScan and Amgen is that the cash milestones ensure a cash runway for TCRX, potentially even until they become commercially viable and profitable.
Here’s a breakdown of the press release in layman’s terms, so anyone without background or knowledge in this space can better understand:
Amgen and TScan Therapeutics are teaming up to find new treatments for Crohn’s disease, a chronic condition that causes inflammation in the gut. TScan has a unique platform called TargetScan that can identify the proteins recognized by the immune system in people with the disease. Amgen will use this information to create new drugs to treat Crohn’s disease.
As part of the deal, TScan will get an upfront payment of $30 million from Amgen and could earn more than $500 million if the collaboration is successful. Amgen will have the rights to develop and sell any new drugs from this partnership.
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Both companies will be responsible for their research costs, and Amgen can expand the collaboration to include another condition called ulcerative colitis. This partnership could lead to new and better treatments for people with Crohn’s disease, who currently have limited options for managing their symptoms.
Here are a couple of blurbs from the management team:
“Anti-inflammatory drugs have traditionally been the standard of care for patients suffering from inflammatory bowel disease, but often lack efficacy and durability,” said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen. “TScan’s platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs.”
“We’re excited to apply our target discovery platform to the autoimmunity space,” said Gavin MacBeath, Ph.D., acting chief executive officer and chief scientific and operating officer at TScan. “Our TargetScan platform, which we have now extended to identify MHC class II targets of CD4+ T cells, is well-suited for the discovery of antigens targeted by the immune system in inflammatory bowel disease. We look forward to developing the value of our platform both in this partnership with Amgen and in other autoimmune diseases.”
What’s retail saying?
As per usual, with gains of around 135%, you can probably guess that retail is all over it. Investors practically all over the internet keep their eye on the stock for potential entry points utilizing various day trading techniques.
Interestingly, some traders are surprised it managed to trade such massive volumes early intraday. If you look at their chart from the prior months, the average volume was relatively minuscule – sometimes trading as low as 5K shares a day. Compared to the ~27M shares traded at the time of writing, that’s a massive shift.
$TCRX #TCRX nice wake up call watch the break above 5.47 to potential 6.25 test pic.twitter.com/FvoAYEFslG
— APFK_ASIAN PICASSO. (@FLiPTek81) May 9, 2023
$TCRX deserves 1000% 30m upfront 500m contract!
— SHANA (@shanazaman) May 9, 2023
$TCRX ✅✅great earnings 75%gain for me
— Ethio-TradE (@alemcharity) May 9, 2023
$TCRX guess they're not done screwing with people yet. That thing looked dead next thing you know, BAM!
— madaz (@madaznfootballr) May 9, 2023
$LCID massive buyers check orderflow. Count the +ve delta numbers and check sizes. $PLTR $MOBQ $IDEX $CLRO $PYPL $TSLA $FFIE $AMD $TCRX $SOXL $SQQQ $TQQQ $NVAX $PLUG $ENSC $BOIL $XELA $NKLA $CVNA $AAPL pic.twitter.com/d0RaG1xvQl
— Time Traveler Carlssin's Trades (@StockMarketMcro) May 9, 2023
We will update you on TCRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with TCRX.
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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.
Image by Gerd Altmann from Pixabay
On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual. Although the surge may be linked to the news from the previous day, it is difficult to determine as there was not much movement on April 26.
However, sometimes it only takes the right attention from investors to create such positive rallies. It is worth noting that $CFRX has a low float of 1.53M, which can lead to extreme volatility and provide retail traders an opportunity to make significant gains.
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Summary of latest PR on April 26, 2023
ContraFect Corporation is a clinical-stage biotechnology company developing new treatments for antibiotic-resistant infections. They recently announced that they initiated a Phase 1b/2 study to test the safety, drug disposition, and efficacy of their drug candidate, Exebacase, in patients with chronic prosthetic joint infections (PJI) of the knee. The study is in France and is randomized, double-blind, and placebo-controlled, meaning some patients will receive the drug, while others will receive a placebo. The study will have two parts: Part I will evaluate the drug’s efficacy, safety, and pharmacokinetics at an early six-week time point, while Part II will assess the long-term clinical safety and efficacy of the drug for up to two years. The CEO of ContraFect Corporation is optimistic about the potential of Exebacase to replace the current surgical treatment for chronic PJI, which has not shown significant improvement in clinical outcomes in recent decades.
What are retail traders saying?
https://twitter.com/RealWillTopol/status/1651553835801001986?s=20
$CFRX
Running in Pre Market Almost +100% From PDC— Avid Trader (@RealAvidTrader) April 27, 2023
$CFRX Why LONG? 🔍👁
Premarket long pattern from the system in room
– dilution above $4
– key level $4
– shorts trapped this early morning
– pullback on trend following
– microfloat + high volumeLive Trading Alerts & Screenshare at https://t.co/ooLvigTt4P #smallcaps… pic.twitter.com/dLX0ZhUwa7
— JTrader (@jtraderco) April 27, 2023
$CFRX $2.12 $2.18 $2.25 if the next low is higher we’re in a good spot!!! https://t.co/axr4eAWTnw pic.twitter.com/k35XYJqQHI
— BULLISHWIRE (@BULLISHWIRE) April 27, 2023
It is worth noting that there has been some speculation about the events that have unfolded and the underlying factors that have led to them.
We’ve observed a subset of traders that capitalize on the volatility by adopting a watchful approach towards stocks, including $CFRX, to generate quick profits.
However, it is essential to exercise caution when considering following their lead, given the high risk associated with their investment strategies and the prevailing market conditions. While we do not typically recommend emulating their investment decisions, it may be an intriguing endeavor for those willing to assume a certain level of financial risk with funds they can afford to lose.
About ContraFect Corp (NASDAQ: CFRX)
ContraFect is a company that focuses on finding new ways to treat life-threatening infections resistant to antibiotics. Antibiotic-resistant infections are responsible for an estimated 700,000 deaths each year worldwide. ContraFect is developing new medical treatments called DLAs that include lysins and amurin peptides. Lysins are antimicrobial proteins that can quickly kill target bacteria, including those in biofilms, and can work with traditional antibiotics. Amurin peptides can fight many antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. ContraFect believes that lysins and amurin peptides will effectively fight antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections. The company has completed a Phase 2 clinical trial for their lead lysin candidate, exebacase, designated by the FDA as a Breakthrough Therapy for treating MRSA bloodstream infections, including right-sided endocarditis, when combined with traditional antibiotics.
We will update you on CFRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with CFRX.
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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.
Image by Sasin Tipchai from Pixabay
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