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Regen BioPharma Inc (OTCMKTS: RGBP) Major Reversal Brewing as Biotech Looks to Commercialize its Modified mRNA anti-cancer Vaccine & Accelerate Clinical Development of its NR2F6 Therapies

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Regen BioPharma Inc (OTCMKTS: RGBP) has been steadily dropping since topping out at $0.0819 in September of last year. Now it looks like its oversold and ready for a major reversal and speculators are beginning to accumulate into the selling which is starting to wane at current levels. RGBP has a massive following of shareholders, many of them international that will jump on board at any hint that the bottom has been reached; once RGBP begins to move to the upside it could be fast and furious. The Company has accomplished a lot since the last time we reported on it when they had just accomplished a number of wins including going “pink current” and becoming fully compliant, settlings the lawsuit with Chemdiv, growing the Companys valuable patent portfolio as well as granting two licensees to Oncology Pharma for which RGBP was paid $1,905,000 in cash and securities. More recently Regen began a development program to commercialize its modified mRNA anti-cancer vaccine targeting the Survivin protein. They also announced a program to accelerate the clinical development of its NR2F6 therapies. The Company intends to combine modified mRNA technology with Regen’s existing siRNA (small interfering RNA) intellectual property targeting the NR2F6 nuclear receptor which has been identified as a potentially very important immune cell inhibitor (an immune checkpoint) and cancer stem cell differentiator.  

Microcapdaily has been reporting on RGBP since early last year. The last time we covered the Company we stated among other things: “RGBP is one of the most followed stocks in small caps with a huge investors base and it has a long history of big moves skyrocketing to 8 cents plus twice over the past 12 months. There are also plenty of buyout rumors on RGBP; according to many investors It appears there may be a possible merger acquisition looming with Precigen or another big pharma which would make sense as the CEO of Precigen (PGEN) Helen Sabzevari is on RGBP’s Scientific Advisory Board. PGEN trades on Nasdaq with a Market Cap of $766 million. RGBP is in the same clinical therapeutic niche market of Oncology-Immunology candidate drug development that Precigen is in including the same mRNA vaccine technology so logically speaking it would make sense if PGEN straight up buys-out RGBP or does a merger acquisition and the motive to do this are the numerous valuable Patents RGBP owns that address enormous billion-dollar markets.” 

Regen BioPharma Inc (OTCMKTS: RGBP) is focused on the immunology and immunotherapy space. The Company is focused on rapidly advancing novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is focused on mRNA and small molecule therapies for treating cancer and autoimmune disorders.  

Regen owns a valuable intelectuable property portfolio including 8 issued patents and 13 published patent applications. Zander Therapeutics, Inc. (a company under common control) has been granted an exclusive license to develop and commercialize IP controlled by the Company for non-human veterinary therapeutic use. Regen has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize “Antigen specific mRNA cellular cancer vaccines” for the treatment of pancreatic cancer and KCL Therapeutics, Inc. has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize certain intellectual property for the treatment of colon cancer. 

The Company is led by CEO David Koos who has over 30 years of investment banking and venture capital experience.  He has a deep knowledge of startup businesses, public markers and SEC reporting companies.  Dr. Koos has extensive relationships with large and small financial institutions, hedge funds and entities that Regen BioPharma expects to leverage for company growth. Dr. Koos has a Ph.D. in Sociology and a Doctor of Business Administration with an emphasis in finance.  Additionally, he has authored / co-authored numerous peer reviewed journal articles. Dr. Koos worked hard to get the filings up to date and get the Company compliant which has recently been completed with RGBP now “pink current”  

https://twitter.com/TrelloThaGod/status/1509124476910374915

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RGBP

On February 11 RGBP announced it is embarking on a development program to commercialize its modified mRNA anti-cancer vaccine targeting the Survivin protein.  In the first phase of the development program, Regen will design and have experiments carried out that will form the initial series of pre-clinical studies required as part of an FDA IND submission. The patented technology (patent issued in Aug, 2021) is a cellular vaccine that uses a modified mRNA molecule expressing peptides of Survivin which are exposed to dendritic cells.  These dendritic cells are then matured and infused into the cancer patient’s circulation where they are expected to home in on the cancer and destroy it.  There are currently several clinical trials ongoing in the U.S. and Europe using Survivin as a vaccine for multiple different cancers which further supports this approach. 

Survivin is the smallest member of the Inhibitor of apoptosis (IAP) family of proteins, involved in inhibition of apoptosis (a form of programmed cell death that occurs in multicellular organisms) and regulation of cell cycle. These functional attributes make Survivin a unique protein regulating cell proliferation and cell death. Expression of Survivin in tumors correlates with not only inhibition of apoptosis and a decreased rate of cell death, but also resistance to chemotherapy and aggressiveness of tumors. Therefore, Survivin is an important target for cancer vaccines and therapeutics. This technology has been out-licensed for use in pancreatic cancer which leaves Regen dozens of other potential indications. 

In February Oncology Pharma, Inc. announced it will jointly develop Regen’s patented ANTIGEN SPECIFIC MRNA CELLULAR CANCER VACCINES (“MRNA Vaccines”). In April of 2021 ONPH was granted an exclusive right and license for the development and commercialization of the MRNA Vaccines for the treatment in humans of pancreatic cancer. The current intent is that IND (“Investigational New Drug Application”) enabling studies are to be commenced and completed with Regen providing the scientific expertise, laboratory access and modified mRNA and cellular manufacturing needed to complete the studies and ONPH providing the required financing. 

On March 10 RGBP announced a program to accelerate the clinical development of its NR2F6 therapies. The Company intends to combine modified mRNA technology with Regen’s existing siRNA ( small interfering RNA)  intellectual property targeting the NR2F6 nuclear receptor which has been identified as a potentially very important immune cell inhibitor (an immune checkpoint) and cancer stem cell differentiator. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes (the cell’s protein-making machinery).    

Regen has filed an Investigational New Drug Application  (IND#16928) for their drug termed tCellVax   with the U.S. FDA. tCellVax is intended to utilize siRNA to silence NR2F6 activity in human immune cells thereby activating these immune cells in such a way that they can attack cancer cells. The Company believes that adding new intellectual property utilizing modified mRNA will profoundly simplify the drug development process and thus speed development. Dyo Biotechnologies has been contracted to assist Regen with the development of the above mentioned technology. Regen is in the process of drafting a new patent application pertaining to this intellectual property. 

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Currently trading at a $28 million market valuation RGBP has 4,580,002,832 shares outstanding and a debt load that has caused significant dilution in the past. But RGBP is an exciting story developing in small caps, at current levels the selling pressure that decimated the share price from over $0.08 to half a penny is waning and many speculators are accumulating with a belief that a major reversal is about to happen. As we said, once RGBP begins to move to the upside it could be fast and furious. RGBP is no stranger to big moves and has runner in its blood skyrocketing to $0.0819 not once but twice in the past year alone. The stock is currently trading well below established support levels at $0.01 just a year ago and has a significant gap to fill from current levels. We will be updating on RGBP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with RGBP.

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Disclosure: we hold no position in RGBP either long or short and we have not been compensated for this article

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Farmer Brothers (NASDAQ:FARM) Announces $100 Million Sale of Northlake Facility, Shifts Production with Focus on Profitability

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Farmer Bros. Co. (NASDAQ: FARM) shares rocketed 88% within the first hour of the opening bell on June 7, 2023.

Farmer Bros. Co. (NASDAQ: FARM) shares rocketed 88% within the first hour of the opening bell on June 7, 2023. This national distributor of coffee and tea intends to sell its direct shipping facility in Northlake for $100 million to TreeHouse Foods (NYQ: THS) and transfer its production operations to Portland, Oregon. The sale includes the 180 employees currently employed at the Northlake plant.

According to $FARM’s CEO Deverl Maserang, this move allows the company to concentrate primarily on its direct store delivery (DSD) business, which is the most profitable and offers the highest growth potential. Maserang stated that the company aims to ensure its direct ship customers are well-served by a national leader while focusing on DSD. After the deal is finalized, Farmer Brothers will relocate its remaining DSD business to its Portland roasting and production plant while maintaining its corporate headquarters in Texas by leasing space in Northlake.

2017 Farmer Brothers first made headlines when it acquired Boyd’s Coffee for nearly $60 million. And just recently, in 2021, Farmer Brothers announced opening a West Coast distribution center. Maserang’s focus is profitability. For a company bringing in an incredible ~496M in revenue annually, you’d think that’s a given. Yet they still reported a ~15M net loss on their June 30th, 2022 earnings, and TTM is ~28M net loss.  

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Farmer Brothers’ direct store delivery business serves coffee, tea, spices, breakfast, and brunch products to 45,000 locations nationwide through a network of 80 independent branches, five distribution centers, and almost 240 routes. Its customer base includes restaurants, food service operators, convenience stores, hotels, casinos, healthcare facilities, and grocery chains.

Founded in 1912, Farmer Brothers is known for its primary brands, such as Farmer Brothers, Artisan Collection by Farmer Brothers, Superior, Metropolitan, China Mist, and Boyd’s. Its sales for fiscal year 2022 reached $469.2 million.

Following the sale of the Northlake facility, the company estimates that its annual revenue will decrease to approximately $350 million. However, as mentioned, their focus is improving profit margins. Chief Financial Officer Scott Drake stated that shifting towards a DSD-focused organization would enhance internal efficiency, reduce operational costs, and increase margins. The company plans to use the proceeds from the sale to pay off debt and streamline its operations.

TreeHouse Foods, headquartered in Oak Brook, Illinois, is a prominent manufacturer of private-label food and beverages in North America. The company operates 26 production facilities in the United States and Canada, including existing locations in Dallas and Carrollton. It was established in 2005 as a spin-off of Dallas-based Dean Foods Co. In 2016, TreeHouse Foods acquired the private brands business from Conagra Brands, marking its most significant acquisition and nearly doubling its size. In 2022, the company reported sales of $3.45 billion.

Analyst Buy Rating Suggests Strong Potential for Growth

As of June 7, 2023, Farmer Bros Co (FARM) had a median target price of $6.00, according to an analyst providing a 12-month price forecast. This indicates a significant increase of 81% compared to the last price of $3.30. The high and low estimates for the stock were also $6.00, reflecting a consensus among analysts regarding FARM’s strong growth potential. An investment analyst polled on the matter has maintained a consistent buy rating for Farmer Bros Co since August. This rating suggests that the company is expected to perform well, and investors are advised to consider purchasing shares. Regarding FARM’s current quarter earnings, the company reported a loss per share of $0.60 and sales of $121.2M. As always, it is essential for investors to carefully evaluate their financial circumstances and risk tolerance before making any investment decisions.

We will update you on FARM 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.

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Hoth Therapeutics (NASDAQ: HOTH) Makes Groundbreaking Progress in Alzheimer’s Research through HT-ALZ Therapy

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Hoth Therapeutics (NASDAQ: HOTH) made significant strides in Alzheimer's disease (AD) with its experimental therapy, HT-ALZ.

Hoth Therapeutics (NASDAQ: HOTH) made significant strides in Alzheimer’s disease (AD) with its experimental therapy, HT-ALZ, which showed promising results in preclinical studies. Following the announcement of these positive outcomes, the company experienced a remarkable 135% share value surge after Tuesday’s opening bell. While Hoth primarily focuses on dermatology, specifically atopic dermatitis and inflammatory skin conditions, their foray into AD research demonstrates their commitment to addressing unmet medical needs.

More on the HT-ALZ Study for Altzheimers Disease (AD)

In a recent study at Washington University in St. Louis, HT-ALZ showcased encouraging effects, particularly in improving spatial memory, with the higher dosage proving the most effective. Alzheimer’s disease is a degenerative neurological condition characterized by the accumulation of amyloid β (Aβ) plaques and neurofibrillary tangles of Tau protein in the brain, leading to symptoms such as dementia. Hoth’s initial data demonstrated a significant reduction in Aβ levels in both male and female mice with AD after acute treatment with HT-ALZ, compared to the placebo and baseline Aβ levels.

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Hoth Therapeutics has completed several behavioral tests and looks forward to sharing more data as it becomes available. This significant progress in their AD research highlights the company’s dedication to developing potential therapies for this debilitating disease.

Driving Forces Behind the Expansion of Alzheimer’s Disease Research

Alzheimer’s disease has been receiving increased attention from preclinical biotech companies for several reasons:

  • Growing prevalence: Alzheimer’s disease is a significant and escalating public health issue due to its increasing prevalence worldwide. As populations age, the incidence of Alzheimer’s is expected to rise, creating a greater need for effective treatments and interventions.
  • High unmet medical need: There is no cure for Alzheimer’s disease, and the available treatments only provide limited symptomatic relief. This unmet medical need presents an opportunity for biotech companies to develop innovative therapies that can potentially slow down the progression of the disease or target its underlying causes.
  • Advancements in understanding: Over the years, significant progress has been made in unraveling the complex mechanisms and underlying pathology of Alzheimer’s disease. This improved understanding of the disease has sparked renewed interest among biotech companies, as it provides a foundation for the development of novel therapeutic approaches.
  • Technological advancements: The advancements in various scientific and technical fields, such as genomics, proteomics, and imaging techniques, have facilitated better disease characterization and identification of potential drug targets. These tools and technologies enable biotech companies to conduct more detailed research and develop therapies targeting specific pathways or biomarkers in Alzheimer’s.
  • Supportive regulatory environment: Regulatory agencies have recognized the urgent need for effective Alzheimer’s treatments and are willing to support and expedite the development and approval processes. This has encouraged biotech companies to invest in Alzheimer’s research and development.

Centers for Medicare & Medicaid Services (CMS) reimbursement For Alzheimer’s Disease (AD)

On a related note, the Centers for Medicare & Medicaid Services (CMS) has announced plans to broaden coverage for Alzheimer’s drugs once they receive full approval from the Food and Drug Administration (FDA). However, CMS’s proposal requires patients to participate in registries that collect real-world data. The first drug that could be covered under this plan is Eisai’s Leqembi, pending FDA approval. CMS’s decision aims to ensure coverage for Medicare Part B enrollees who meet specific criteria, including participation in registries to gather evidence on drug effectiveness.

While the registry requirement has faced criticism as an unnecessary barrier, CMS officials defend it, citing the importance of real-world evidence in transforming patient care. CMS collaborates with multiple organizations to establish registries, but more details and enrollment information are needed.

The broader CMS reimbursement for Alzheimer’s drugs is expected to benefit Eisai, Biogen, and other companies in the anti-amyloid space. Given that over 5 million Medicare beneficiaries are affected by Alzheimer’s, the market potential is substantial. Analysts project significant revenue for Eisai and Biogen from Leqembi, with estimated annual sales in the United States reaching billions of dollars.

Conclusion

In conclusion, the combination of factors such as the growing prevalence of Alzheimer’s disease, unmet medical needs, advancements in understanding, technological progress, and supportive regulations have contributed to the increased attention and investment in AD research by preclinical biotech companies. Hoth Therapeutics’ remarkable improvement in its HT-ALZ study exemplifies the significance of these advancements and highlights the company’s potential in addressing this challenging disease.

We will update you on HOTH 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.

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Strong Financials and Social Media Buzz Propel Forza X1, Inc. (NASDAQ:FRZA) to New Heights

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Forza X1, Inc. (Nasdaq: FRZA) shares witnessed an exceptional and unforeseen surge in its share price, skyrocketing by 151% early morning of June 5th, 2023.

Forza X1, Inc. (Nasdaq: FRZA) shares witnessed an exceptional and unforeseen surge in its share price, skyrocketing by 151% early morning of June 5th, 2023. This surge was accompanied by an unprecedented level of trading volume, marking a significant departure from the previously observed average. Notably, the stock’s trading volume had been relatively low in recent months, with numerous days experiencing trading activity of less than 1,000 shares. Without any apparent news or filings, the cause behind this sudden surge remains a subject of intrigue and speculation among market participants.

What happened?

Firstly it’s important to note that $FRZA is a spin-off of Twin Vee PowerCats Co. (Nasdaq: VEEE). $VEEE is the parent company handling the design, manufacturing, and distribution of recreational and commercial, off-shore power catamaran boats while $FRZA is the new developer of electric sport boats with a mission to accelerate the adoption of sustainable recreational boating.

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Upon examination of the company, no discernible filings or press releases have been identified to account for today’s remarkable shift. However, it seems that a tweet disseminated by the company caught the attention of retail investors, subsequently generating an enormous surge in trading volume.

This recent occurrence serves as yet another compelling demonstration of the significant impact that the retail community can exert when armed with information regarding a small float micro-cap stock, particularly when the conditions align favorably and validate the potential for substantial gains. The tweet, skillfully crafted by the company’s social media team, featured a compelling GIF and clever “Don’t miss the boat” blurb, demonstrating a keen understanding of their business’s essence. 

The timely and engaging content proved to be a perfect execution, capturing the attention and imagination of investors in a manner that resonated deeply with the nature of the company’s operations.

Overview of Twin Vee PowerCats Co. Financials

Could the surge in share price also reflect the market’s enthusiastic response to Twin Vee’s strong financial results for the first quarter of 2023? 

On May 15, 2023, Twin Vee PowerCats Co. released its financials demonstrating a substantial increase in net revenue and notable improvements in the gas-powered boat segment.

https://twitter.com/JohnZidar/status/1665685698400141313?s=20

Twin Vee PowerCats Co. (Nasdaq: VEEE) reported strong financial results for the first quarter ended March 31, 2023. The company experienced a notable 51% increase in net revenue, reaching $8.9 million compared to $5.9 million in the same period last year. The gas-powered boat segment achieved a net income of $181,000, significantly improving from the net loss of $626,000 in Q1 2022.

However, as per GAAP accounting policy, Twin Vee’s consolidated financial statements resulted in a total net loss of $1.8 million for the quarter, primarily due to their majority ownership in Forza X1, Inc. (Nasdaq: FRZA), an electric boat company. Twin Vee reported cash, cash equivalents, restricted cash, and marketable securities of approximately $12.6 million as of March 31, 2023.

The company has been expanding its product lineup, including introducing the Aquasport mono-hull boat brand. Twin Vee is confident these efforts will contribute to business scalability and brand growth. They aim to optimize inventory levels and production costs while closely monitoring market conditions, dealer inventories, and economic indicators.

Financial highlights for Q1 2023

  • Total revenue: $8,877,000 (51% increase compared to Q1 2022)
  • Gross profit: $3,222,000
  • Net income from gas-powered boats segment: $182,000
  • Net loss from Forza X1 (electric boat entity): $2,005,000
  • Loss from Fix My Boat (franchise business): $5,000
  • Adjusted net loss (excluding non-cash charges): $1,347,000
  • Adjusted net income from gas-powered boats segment: $265,000

Twin Vee’s consolidated cash, cash equivalents, restricted cash, and marketable securities were $23,457,000 as of March 31, 2023. Forza X1 reported $10,683,000 in the same category, while Twin Vee’s core business had $12,643,000, and Fix My Boat had approximately $132,000.

We will closely monitor the performance of Forza X1, Inc. (Nasdaq: FRZA) in the coming weeks, considering that it is a spinoff from its parent company. It is crucial to conduct thorough research, particularly for companies like FRZA that have yet to achieve profitability. However, it is worth noting that the parent company has been making notable progress, as evidenced by its recent financial results, which revealed a substantial increase in the bottom line.

We will update you on FRZA 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.

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