First Wave BioPharma (NASDAQ: FWBI) experienced an impressive pre-market surge of approximately 85% on Thursday following the announcement of a licensing agreement with Sanofi (NASDAQ: SNY) concerning Capeserod, a potential treatment for gastrointestinal tract (GIT) disorders.

The Agreement:

According to the terms of the agreement, the biotech company based in Boca Raton, Florida, will obtain an exclusive global license for Capeserod from the French pharmaceutical giant and assume responsibility for its clinical development in exchange for an initial payment described as “modest.” Additionally, there will be further payments tied to developmental milestones and single-digit royalties based on net sales. Sanofi (SNY) will retain the right of first refusal for the future commercialization of Capeserod.

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Sanofi’s research on Capeserod, backed by cutting-edge artificial intelligence (AI) analysis, suggests that this drug could be a game-changer for a range of gastrointestinal disorders. These conditions represent massive markets with significant unmet medical needs. It’s like discovering a potential solution to some major health challenges.

Capeserod:

Sanofi has a track record with Capeserod, having already conducted seven Phase 1 and two Phase 2 trials to explore its potential in treating neurological disorders. These trials involved over 600 patients, and the good news is that Capeserod showed itself to be safe and well-tolerated. That’s a promising start.

Now, First Wave is eager to get things moving. They’re planning to reach out to the U.S. Food and Drug Administration (FDA) for a meeting as soon as possible. The goal? To hash out a clear plan for developing and regulating Capeserod for gastrointestinal diseases. They’re hoping to kick off clinical trials in 2024, which could be a big step forward in bringing this potential treatment to those who need it.

About First Wave Biopharma:

First Wave BioPharma is a company focused on developing specialized treatments for gastrointestinal (GI) diseases. They’re currently in the clinical-stage, meaning they’re actively testing their therapies on patients to make sure they work effectively.

They have two unique technologies they’re working with. The first one is called adrulipase, which is a special enzyme designed to help people digest fats and other nutrients better. The goal is to make it easier for people with GI issues to absorb these essential elements.

The second technology is niclosamide, a small molecule taken orally. It’s got anti-inflammatory properties, which means it can help reduce inflammation in the body.

Right now, First Wave is especially interested in adrulipase. They’re running Phase 2 clinical trials for it, focusing on patients dealing with exocrine pancreatic insufficiency (FW-EPI). This condition often affects people with cystic fibrosis (CF) and chronic pancreatitis (CP). The hope is that adrulipase can provide these patients with a safe and effective treatment option that doesn’t rely on animal-derived substances, and it might even reduce the number of pills they need to take every day.

But that’s not all. First Wave is also working on multiple programs involving niclosamide. They’re exploring its potential for ulcerative proctitis, ulcerative proctosigmoiditis, ulcerative colitis, and Crohn’s disease, all of which fall under the GI disease umbrella.

In a nutshell, First Wave BioPharma is on a mission to create better, more targeted treatments for GI diseases, and they’ve got some promising candidates in their pipeline.

Their latest collaboration with Sanofi hopes to repurpose Capeserod and focus on its development for various gastrointestinal indications. The company has initiated discussions with the FDA to map out a development and regulatory roadmap for Capeserod, with Phase 2 clinical trials slated to commence in 2024.

We will update you on FWBI when more details emerge, subscribe to Microcapdaily to follow along!

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.

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Mullen Automotive, Inc. (NASDAQ: MULN) has been experiencing significant investor interest in recent months, but its share price has yet to reflect positive fluctuations. The company is actively making headlines and expanding rapidly across various EV verticals globally. Despite announcing a $25 million stock buyback program, MULN’s valuation has not appreciated considerably, remaining at around $100 million market capitalization at time of writing. 

While Mullen’s management team asserts that they are undervalued, their stock price hovers at a meager ~$0.15 per share, falling below Nasdaq’s minimum bid compliance. With a cash position of approximately $235 million, the company shows promise, but further research is needed to understand potential obstacles hindering their growth. Let’s delve into a condensed overview of their news flow to grasp the extent of their growth throughout July and the tail end of June.

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July 18th, 2023

A company MULN acquired a majority interest in, called “Bollinger Motors” launched its “design validation” pilot builds for the B4 all-electric Class 4 chassis cabs, aimed at testing and demonstration purposes. The pilot vehicles are being manufactured in collaboration with Roush Industries, Inc. in Livonia, Michigan. The company expects to roll out the first five completed chassis cabs this summer, followed by over 15 vehicles by the end of Q3 2023. The B4, designed with extensive experience in all-electric truck development, offers limitless upfit options for fleet customers and will be showcased at a demonstration event in September. Additionally, the B4 will qualify for a federal purchasing incentive, providing up to 30% of the vehicle’s cost, capped at $40,000, with deliveries set to begin in July 2024.

https://twitter.com/NashMadeit_126/status/1681415557222940696?s=20

July 17th, 2023

Mullen Automotive, Inc. (NASDAQ: MULN) has received a 30-unit order for its Mullen-GO™ Commercial Urban Delivery EV from Newgate Motor Group, marking the first sale of Mullen vehicles in Europe. Newgate, a respected dealership group based in Ireland, will handle marketing, sales, distribution, and servicing for the Mullen-GO in Ireland and the United Kingdom. The Mullen-GO, designed for quick deliveries in European cities, is fully certified and ready for sale in initial markets such as the U.K., Germany, Spain, France, and Ireland. Newgate Motor Group, with over 40 years of experience, represents reputable brands and offers top-notch service at its facility in Navan.

$muln Failure to Deliver in the next two weeks is approx. 269,178,955.
Shorts, prepare for the impossible to become possible. Go Mullen! @Mullen_USA @DavidMichery #MULN pic.twitter.com/90wxqSGhPK

— Roy (@Roy00794008) July 17, 2023

July 16th, 2023

Mullen Automotive (NASDAQ: MULN), initiates the transfer of its Class 1 EV cargo van vehicles from its Indiana plant to its Mississippi plant for final assembly. With over 350 vehicles already transferred and another 300 scheduled for transfer this year, the Tunica plant is nearing the production start and deliveries of Class 1 and Class 3 vehicles. Mullen Automotive’s CEO and chairman, David Michery, expressed excitement about delivering vehicles to customers starting in August 2023, anticipating continued revenue growth throughout the last six months of the year. The Southern California-based automotive company is focused on developing the next generation of electric vehicles, including the Mullen FIVE EV Crossover, Mullen-GO Commercial Urban Delivery EV, Mullen commercial Class 13 EVs, and Bollinger Motors, featuring electric SUV trucks and Class 46 commercial offerings.

https://twitter.com/CrozzTrade/status/1680956372001718274?s=20

July 13th, 2023

Mullen Automotive, Inc. (NASDAQ: MULN) launches an EV pilot program in collaboration with New York Power Authority (NYPA). Commencing on July 6, 2023, NYPA is conducting tests on Mullen’s all-electric Campus Delivery Utility Vehicle, the EV Cargo Van, at its upstate New York location. As a leading power generation and transmission company committed to clean energy in New York, NYPA’s 2030 Vision aims for a thriving, resilient state powered by clean energy. Mullen’s Chief Commercial Officer, John Schwegman, expressed excitement about partnering with NYPA to work towards eliminating carbon emissions in New York, emphasizing the significance of sustainable initiatives in various states. Mullen’s CEO and Chairman, David Michery, echoed the excitement about entering the utility provider market with their EVs, specifically noting the suitability of the EV cargo van for closed workplace campus scenarios. The Mullen CAMPUS, designed for low-speed, closed campus use, is a highly efficient electric van aligned with NYPA’s efforts towards sustainability. As the largest state public power organization in the nation, NYPA operates multiple generating facilities and transmission lines, with over 80% of its electricity produced from clean renewable hydropower. NYPA funds its operations through bond sales and electricity revenues.

$MULN David (ceo) with a recent massive buy – surprised nobody even noticed! pic.twitter.com/LtskrJGkar

— Summerlove (@summerlove5112) July 17, 2023

July 11th, 2023

Mullen Automotive, Inc. (NASDAQ: MULN) introduces PowerUP, its new mobile EV charging truck capable of providing both level 2 and level 3 DC fast charging to electric vehicles in scenarios where power is limited or unavailable, such as roadside assistance and emergency response situations. The PowerUP will be featured on Mullen’s upcoming 2023 “Strikingly Different” EV Tour, providing fast charging capabilities to Mullen’s EVs during the tour. The mobile charging truck, based on a Class 5 truck platform, offers up to 150kW of continuous power generation, equipped with two level 3 DC fast chargers and four level 2 chargers. Mullen plans to offer different configurations of the PowerUP for immediate sale via advance order, making it available for commercial applications and emergency teams. The EV tour, starting in August 2023, will cover various locations on the East Coast, Midwest, Northwest, and West Coast, showcasing Mullen’s lineup of electric vehicles, including the ultra-high-performance Mullen FIVE RS with a top speed of over 200 mph and acceleration from 0-60 mph in just 1.95 seconds.

https://twitter.com/Sam1am1911/status/1679476765155282950?s=20

July 5th, 2023

Mullen Automotive, Inc. (NASDAQ: MULN) enlists the services of Christian Attar, also known as Christian Levine Law Group, in partnership with Warshaw, Burstein, LLP, to address and combat potential illegal naked short selling activities targeting the company’s common stock. In response to reports received from ShareIntel indicating possible market manipulation schemes, Mullen intends to investigate and expose any wrongdoing involved. Christian Attar and Warshaw Burstein have a track record of successfully prosecuting and securing substantial damages against broker-dealers, market-makers, hedge funds, and asset-based lenders engaged in such market manipulation practices. Mullen’s CEO and Chairman, David Michery, emphasizes their active efforts in investigating naked short selling and their determination to take appropriate legal action against market manipulators employing illegal tactics like naked short selling and spoofing. Christian Attar operates internationally and domestically, with its headquarters located in Houston, Texas, specializing in various civil litigation cases, including shareholder disputes, partnership disputes, and stock fraud.

It certainly doesn't help. Dilution aside, why does it seem like @DavidMichery is doing almost every single thing right and we still get F-Ed. I feel it's because we have something here, something HUGE. $muln #muln #bollingermotors pic.twitter.com/j5kqAE0Zuf

— Jason Bleecker (@bsdyork) July 17, 2023

June 29th, 2023

Mullen Automotive, Inc. (NASDAQ: MULN) achieves a notable milestone with the sale of 22 EV cargo vans to the Randy Marion Automotive Group, resulting in a recorded revenue of $308,000 for the quarter ending June 30, 2023. All vehicles are scheduled for shipment, with the first batch departing on June 29, 2023, from Mullen’s assembly plant in Tunica, Mississippi, to the Randy Marion Automotive Group in North Carolina, the authorized distributor of Mullen’s commercial EVs in the U.S. The company is also actively pursuing six Campus EV Pilot Programs in various industries, with further details expected in future announcements. The Mullen commercial team has been engaging in national events, showcasing Class 1 and Class 3 vehicles, and plans to present its commercial vehicle lineup during the 2023 “Strikingly Different” U.S. tour starting in August 2023. Mullen’s CEO and Chairman, David Michery, regards these shipments as a significant achievement, marking the company’s first recorded revenue on the financial statement, which will be reflected in the June 30, 2023, 10-Q report.

$MULN shareholders, now that production is in full swing, remember, we’re not here for a quick buck. We’re here to make a dent in the universe. True success is not about short-term gains. Stay long because the best is yet to come.@DavidMichery @Mullen_USA #mullenusa #Mullen #MULN pic.twitter.com/XlpOQvuiLT

— Roy (@Roy00794008) July 14, 2023

Insights from InvestorPlace: A Concise Overview

InvestorPlace wrote a bearish article on MULN, here’s the consolidated version: Mullen Automotive’s (NASDAQ: MULN) stock has faced a significant decline after its removal from the Russell 2000 Index due to failure to meet FTSE Russell’s price requirements. This exclusion from the index may result in selling pressure on MULN shares, despite the company having a substantial cash reserve of over $235 million. Mullen’s market capitalization remains low at around $30 million, leading to concerns about dilution as the company recently announced a potential resale of up to 2.33 billion shares, further increasing the number of outstanding shares. The company implemented a reverse stock split to meet Nasdaq’s listing requirements, but its stock price has continued to fall, putting it at risk of delisting from the exchange and will likely have to do another reverse stock split in the near future. Mullen’s attempts to integrate artificial intelligence technology into its vehicles have not generated substantial market enthusiasm, and its optimistic outlook amid challenging financial circumstances remains unconvincing. As a result, it is advised against holding MULN stock in 2023.

Shorts are currently increasing 14.08M shares of $MULN pic.twitter.com/YVVK0n321c

— Financial Journey (@FinJourney) July 17, 2023

Conclusion:

Extensive research across multiple sources has unveiled a wide array of opinions regarding $MULN’s trajectory in the upcoming years. While the company’s management team perceives it as severely undervalued, a critical examination of their financial standing reveals a lack of profitability and no recorded revenue to date. Nevertheless, $MULN may stand at a crucial turning point, as they embark on commercializing several products, potentially leading to revenue generation. Yet, YahooFinance’s data highlights a staggering net income loss of approximately $739 million from operating activities, indicating that positive fundamentals may remain distant in the foreseeable future.

We will update you on MULN when more details emerge, subscribe to Microcapdaily to follow along!

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.

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Biodexa Pharmaceutical’s (NASDAQ: BDRX) shares have shown substantial volatility during today’s trading session, experiencing gains of nearly 150% at various points. Biodexa specializes in the development of treatments for brain cancer. More importantly, the company recently completed the enrollment and treatment phase for nine children participating in a study involving their lead asset, MTX110.

Allow us to provide a simplified explanation of the announcement, to enhance your understanding of the company’s efforts to improve clinical outcomes for primary and metastatic brain cancers.

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About MTX110 Clinical Trial:

In this particular study, the enrolled children, aged between 4 and 17 years, underwent radiation therapy as per standard medical practice. After that, they had surgery to implant a special catheter and a programmable pump directly into their tumors. The purpose of this implant is to deliver a drug called MTX110 into the tumor site. Out of the nine patients, eight have received two infusions of MTX110 via a technique called convection-enhanced delivery (CED), with different concentrations of the drug being tested.

The important update is that there have been no reports of serious side effects or toxicities related to the use of MTX110 in this study. The drug has been well-tolerated by the patients.

The study aims to evaluate the safety and effectiveness of MTX110 in treating children with DMGs, which is a highly challenging and life-threatening disease. The survival rate for patients with DMGs is very low, and current treatment options are limited. The results of this study are expected to be made public in early 2024, providing valuable information about the drug’s impact on the disease.

Insights from Retail Investors:

As previously mentioned, Microcap stocks often have a limited number of available shares, commonly referred to as a “tight” or “low” float. In the case of $BDRX, they recently underwent a reverse stock split because their stock price fell below the minimum bid compliance standard on NASDAQ. This reverse split was significant, with a ratio of one-for-eighty (1-80), and was effective on July 5th, 2023. Consequently, the number of shares available for trading decreased substantially, leading to a significant increase in trading volatility. It’s worth noting that $BDRX has one of the lowest floats we’ve observed on NASDAQ, with only 220.22k shares available for trading. Many Retail investors would consider this a “Nano-float”. Given the circumstances, it’s understandable that stocks like this can experience highly significant price fluctuations, attracting a large number of investors seeking quick gains through short-term trading strategies.

$BDRX now.. 220k float last 4.95 https://t.co/w8aN576PGS

— Steven Feffer (@sfef84) July 11, 2023

$BDRX one of the lowest floaters out there now. Curious if they come for this one. Can go crazy if they do https://t.co/bHdhIQnqkA

— Zalmy (@greatstockpicks) July 11, 2023

Annnnddddd there’s your post split pump $BDRX. Most of these have had pre and post split pumps. Watch them all with nice share structures imo.

— Pronouns: Your/Stepmom (@MayaTrades) July 11, 2023

If $BDRX gets volume this is gonna explode

— stocks on stocks (@stocksonstocks9) July 11, 2023

About Diffuse Midline Gliomas (DMGs):

DMGs is a type of brain tumor that occurs in the middle part of the brain. It cannot be surgically removed and mostly affects children. The average survival rate is around 9 to 11 months, and most patients die within a year of diagnosis. The current treatments, such as chemotherapy, are not very effective because the drugs have difficulty reaching the brain. About 1,100 people worldwide are diagnosed with DMG each year.

About MTX110:

MTX110 is a modified form of a drug called panobinostat. It is designed to be delivered directly to the tumor site through a catheter system, bypassing the blood-brain barrier. This allows for high concentrations of the drug to be delivered to the tumor while minimizing side effects. MTX110 is being studied for its effectiveness in treating recurrent glioblastoma, pediatric DMG, and recurrent medulloblastoma. Previous studies have shown promising results in laboratory tests using DMG and glioblastoma cells.

About Phase 1 Clinical Trials: 

The primary goal of a Phase 1 clinical trial is to assess the safety and tolerability of a new drug or treatment in a small group of participants. Phase 1 trials are the earliest stage of human testing and usually involve a relatively small number of healthy volunteers or patients. The main objectives of Phase 1 trials are:

Safety: Phase 1 trials aim to identify any potential side effects or adverse reactions associated with the treatment. Researchers closely monitor participants for any negative effects and determine the dose levels that can be tolerated.

Dosage determination: These trials help determine the appropriate dosage range for further studies. Researchers may administer different doses to participants to evaluate the drug’s pharmacokinetics (how the drug is absorbed, distributed, metabolized, and eliminated by the body) and determine the optimal dose for further investigation.

Pharmacokinetics and pharmacodynamics: Phase 1 trials assess how the drug is processed in the body, including its absorption, distribution, metabolism, and elimination. They also evaluate how the drug interacts with the body’s cells and affects the targeted disease or condition.

Preliminary efficacy: Although Phase 1 trials primarily focus on safety, they may also provide initial data on the treatment’s effectiveness. Researchers may evaluate early signs of efficacy or measure biomarkers to determine if the drug is having the desired effects.

Overall, the main goal of a Phase 1 clinical trial is to gather essential information about the drug’s safety profile, establish an appropriate dosage range, and lay the groundwork for further studies in subsequent phases (Phase 2 and Phase 3) to evaluate the treatment’s efficacy and potential benefits.

Conclusion:

Biodexa Ltd (NASDAQ: BDRX) has achieved another significant milestone with its lead asset, MTX110. The limited number of available shares following their stock split has resulted in rapid stock movement, attracting investors seeking quick profits from potential substantial gains. According to their presentation deck, there are several important upcoming milestones and catalysts to monitor in the coming months. These include the release of Phase 1 ‘203 study data in DMG, submission of Phase 2 IND in DMG, the publication of MAGIC-G1 study cohort A PFS data, and the initiation of the Phase 2 study in DMG.

We will update you on BDRX when more details emerge, subscribe to Microcapdaily to follow along!

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.

Picture by Jarmoluk from Pixabay