Genprex Inc (Nasdaq: GNPX) is one of the few clinical stage companies offering exciting investment opportunities in a segment growing at a compound annual growth rate of 19.1%.
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Yesterday, Genprex, Inc. (NASDAQ: GNPX), announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company's lead drug candidate, REQORSA® Immunogene Therapy, in combination with Genentech, Inc's Tecentriq® in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.
In the third quarter of 2023, Genprex expects to enroll the first patient in its Acclaim-3 clinical trial, which is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population. The Company has previously received two other FTDs for REQORSA, for REQORSA in combination with AstraZeneca PLC's Tagrisso® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso, and for REQORSA in combination with Merck & Co's Keytruda® in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda.
It is one of the few plays trading at highly discounted levels while developing therapies and technologies for treating a range of disorders, such as inherited diseases and cancers. Rather than treating patients with drugs or surgeries, Genprex is working on therapies that insert genes into a cell to cure various diseases caused by genetic variants. Gene therapies stand out partly because they are one-time events, although there might be additional dosages.
With the Gene therapy market expected to grow to $29.47 billion from $7.54 billion in 2022, there is every reason to be bullish about Genprex's growth metrics and long-term prospects.
Here are a few reasons why Genprex should be on your watchlist.
TOP GNPX HIGHLIGHTS
* GNPX stock is trading near a 52-week low with RSI near 44 - A strong bounce can happen at anytime.
* Dawson James has a Buy rating on the stock and an average price target of $5.61 - representing over 500% upside potential from current levels.
* Genprex is home to some of the best technologies designed to administer disease-fighting genes most effectively.
* Genprex has made impressive strides in developing REQORSA, its novel treatment for lung cancer.
* With the Gene therapy market expected to grow to $29.47 billion from $7.54 billion in 2022, there is every reason to be bullish about Genprex's growth metrics and long-term prospects.
* While strengthening its diabetes gene therapy program, Genprex, Inc. (Nasdaq: GNPX) entered into an exclusive license agreement with the University of Pittsburgh, granting Genprex a worldwide, exclusive license to certain patent applications and related technology.
Robust Gene Therapy Technologies
Genprex (GNPX) is home to some of the best technologies designed to administer disease-fighting genes most effectively. As a result, its technologies have the potential to provide new breakthrough therapies for large patient populations struggling with cancer and diabetes.
Nanoparticle Delivery System is the first systemic gene therapy delivery platform that can be used to enclose plasmids that deliver tumor suppressor genes. It also administers encapsulated plasmids which are taken up by tumor cells and express any missing proteins in the tumor cells.
In addition, the company has REQORSA, a leading immunogen therapy drug for non-small cell lung cancer. The therapy is administered through the company's systemic gene therapy platform for cancer.
Finally, Genprex boasts of game-changing GPX-002, a diabetes gene therapy comprising a novel infusion process. It relies on an endoscope and adeno-associated virus vector to deliver Pdx1 and Mafia to the pancreas.
Lung Cancer Treatment
REQORSA is the company's lead candidate drug currently in clinical trials for the treatment of non-small cell lung cancer and small cell lung cancer. The novel treatment positions Genprex to be a key player in treating lung cancer, the leading cause of death worldwide. Lung cancer causes more deaths than colorectal, breast, liver and stomach cancer. With the limited benefit from current therapies, Genprex novel candidate drug has what it takes to address the unmet medical need, more so in lung cancer patients.
After successful clinical trials, the candidate drug has already received fast-track designation from the Food and Drug Administration. In a recent Acclaim-1 phase, ½ clinical trial REQORSA, combined with tagrisso(R) (osimertinib) for treating small cell lung cancer, was well tolerated with no dose-limiting toxicities. The Safety Review Committee has already approved continuation into phase 2 expansion. A combination of REQORSA and Osimertinib has already received Fast Track designation from the FDA for use in the Acclaim-1 patient population.
Genprex (GNPX) is already conducting preclinical research as it looks to explore REQORSA's potential use in other solid tumors. It is also exploring how other cancer-fighting genes can be used on its non-viral gene therapy platform.
Multidisciplinary Management Team
Genprex's (GNPX) long-term prospects are further affirmed by its multidisciplinary team of executives and advisors. The broad business experience in biotech and pharmaceutical that the team brings should allow the company to accelerate the development of its novel treatment for lung cancer and address the significant unmet medical need.
The management team boasts of highly experienced personnel as part of its scientific advisory board that reviews research and development activities and provides recommendations to accelerate the development of the moving treatment. There is also a clinical advisory board tasked with overseeing clinical trials to ensure they are up to board or approval by the FDA.
While insiders own about 4.5% of GNPX, their interests are perfectly aligned with that of investors. Likewise, institutions owning about 7.8% of the stock underscore the strong belief in the company's gene therapy pipeline.
In the near term, the investment community could elevate the value of GNPX closer to that of its peers.
The key level that GNPX needs to break over is $0.86and the next level/area after that to watch is $0.93-$0.96.
Institute of Biomedical Research Corp. (OTC: MRES) is a bioceutical company dedicated to the study of alternative plant-based cannabinoids and mental health therapeutics. M2Bio's primary objective is to advance the field of botanical-based medicine through the application of rigorous scientific and medical practices, clinical research, and emerging technologies. Notably, M2Bio is among a select few companies worldwide actively investigating the therapeutic properties of psilocybin, the compound found in magic mushrooms. They are funding research at a university in South Africa to explore new potential uses for psilocybin in treating medical conditions such as depression, inflammation, and substance addiction.
In addition to their research endeavors, M2Bio owns and operates three consumer goods brands: Medspresso(TM), Dr. AnnaRx(TM), and Liviana(TM). These brands offer a diverse range of premium consumer products infused with CBD and mushrooms, including bioceuticals, health and wellness products, and precision foods and beverages. Currently headquartered in Cape Town, South Africa, M2Bio and its brands are strategically positioned in the high-value market segment.
Back in May, on the 25th of 2023, M2Biome announced the launch of its website, designed to cater to healthcare professionals and health-conscious individuals. The website features various sections, including a health blog named 'Digestible Facts,' educational resources, recipes, and more. One notable feature of the website is a diabetes screening tool prominently placed on the home page. This tool enables users to assess their risk of undiagnosed type 2 diabetes (T2DM) and encourages them to pursue further testing. It also serves as a valuable resource for emphasizing the lifestyle changes necessary to reduce the risk of developing T2DM and other non-communicable diseases that share similar underlying pathophysiology. Part of M2Biome's mission is to provide education on health and nutrition while raising awareness about disease risks.
Nicola Royce, the Managing Director of M2Biome, emphasizes the significance of this initiative. In South Africa, it is estimated that around 45% of diabetes cases remain undiagnosed. Unfortunately, many individuals receive a diagnosis only after complications have already arisen, significantly impacting their quality of life and the associated costs of managing their conditions. Given that type 2 diabetes is largely preventable and manageable, M2Biome is dedicated to promoting awareness of the risks involved. Nicola Royce is currently working on further validating the African Diabetes Risk Score to enhance its applicability within the South African population.
In the past 18 months, both the company and its subsidiary, M2Bio Sciences, have achieved significant progress in their mission to develop exceptional health products and solutions, solidifying their reputation as innovators in the global biotech industry. By incorporating cutting-edge AI algorithms and machine learning, the company has successfully created highly efficient nutritional assistance solutions.
Moreover, they have actively pursued research on psychedelic compounds for potential therapeutic applications in mental health disorders. By employing AI-driven techniques for data research and predictive models, M2Bio Sciences has made notable advancements in comprehending the therapeutic potential of psychedelics. Their research has shown promising results in treating conditions such as depression, anxiety, and post-traumatic stress disorder (PTSD) through the use of psychedelics.
Additionally, the company owns and operates three consumer goods brands focused on medicinal cannabis: Medspresso(TM), Dr. AnnaRx(TM), and Liviana(TM). These brands offer a diverse range of premium consumer products infused with CBD and mushrooms, including bioceuticals, health and wellness products, and precision foods and beverages.
In a recent development, M2Bio Sciences' sustainability division, M2Enviro, announced the upcoming introduction of Hempcelium to the world. Hempcelium is an environmentally friendly packaging solution made from a proprietary composite of hemp and mycelium. It is biodegradable and sustainable, serving as an alternative to polystyrene, which is known to be harmful to the environment.
In the latest development on June 27, 2023, M2Bio announced the signing of a letter of intent to acquire JDAX, a prominent cryptocurrency platform that facilitates seamless exchange, trading, and secure storage of digital currencies.
JDAX operates as an advanced digital marketplace, empowering users to engage in the buying, selling, and holding of various cryptocurrencies. It offers essential features such as managing digital wallets, executing trades, and accessing comprehensive market data.
As a South African Fintech company deeply immersed in Blockchain, Web3, and Decentralized Finance (DeFi) technologies, JDAX, also known as the Johannesburg Digital Assets Exchange, holds a significant position in the industry. By aligning with these cutting-edge advancements, M2Bio aims to expedite the traditionally challenging and time-consuming process of natural product drug discovery. Leveraging collaborations with prestigious universities and supported by multiple funded research chairs, the M2Bio Research Team is actively involved in extracting bioactive compounds from a vast collection of African plants renowned for their potential efficacy. Through the utilization of novel extraction methods and AI models, M2Bio significantly accelerates the pace of discovering and characterizing potentially bioactive compounds.
The completion of the acquisition is anticipated to occur by July 31, 2023, or potentially earlier.
Golden Developing Solutions, Inc. (OTC: DVLP) is a holding company operating in the Health and Wellness industry. The company's primary focus is on acquiring companies and pharmacies that specialize in delivering pharmaceuticals and specialty medicines. One of the key aspects of these acquisitions is the ability to provide rapid delivery services to customers. Additionally, DVLP places importance on ensuring that these acquired companies have sufficient medical support to cater to the needs of their customers. The company operates primarily within the United States.
Asset Purchase and Sale Agreement
On September 28, 2022, Golden Developing Solutions, Inc., a Nevada corporation, entered into an Asset Purchase and Sale Agreement with Jai Chamunda New Hudson LLC, a Michigan limited liability company. This agreement entails the Company's acquisition of certain assets currently used in Seller's pharmacy located at 56270 Grand River Ave., New Hudson, MI 48165.
The agreed-upon purchase price under the APA is $1,350,000, which includes an inventory value of $450,000, Rx Data value of $890,000, and a non-compete contribution from the member valued at $10,000. The closing of the transaction is not contingent upon the completion of any due diligence process.
Following the closing, the Company will engage the Seller for a period of thirty days starting from the Closing Date. The Company has agreed to compensate the Seller at a rate of $125.00 per hour, with payment made on a bi-weekly basis upon receipt of an invoice from the Seller.
Purchase Agreement
On September 23, 2022, Renown Pharmaceuticals LLC, a wholly owned subsidiary of the Company, established in the State of Florida, entered into a Purchase Agreement with COD Management, LLC doing business as Orchard Trails Pharmacy. This agreement involves the Company's acquisition of certain assets used in Seller Two's pharmacy located at 23133 Orchard Lake Rd. Suite 101, Farmington, MI 48336. Renown will assume no liabilities of Seller Two.
The purchase price under the Purchase Agreement will be determined based on the following assets:
Seller Two's marketable and usable merchandise inventory at the pharmacy, valued at the original actual cost to Seller Two. Non-leased furniture, fixtures, equipment, computers, transferable software, telephone numbers, and similar items, including fixtures and equipment at the pharmacy, valued at $10,000. All prescription lists, patient profiles, customer lists, prescription files, records related to the pharmacy, and goodwill as of the Closing Date Two, collectively valued at $255,000. A covenant not to compete that will be binding upon Seller and its officers, directors, and shareholders, valued at $10,000.
Asset Purchase and Sale Agreement - One
On October 4, 2022, Golden Developing Solutions, Inc., a Nevada corporation, entered into an Asset Purchase and Sale Agreement with Sai Siva Healthcare, LLC, a Florida limited liability company. This agreement involves the Company's acquisition of certain assets currently utilized in Seller's pharmacy located at 12753 S.W. 42nd St., Miami, FL 33175.
The agreed-upon purchase price under the APA One is $3,050,000, which includes an inventory value of $650,000, RX Data value of $2,390,000, and a non-compete contribution from the member valued at $10,000. The closing of the transaction is not contingent upon the completion of any due diligence process.
The closing of the transactions outlined in the APA One is scheduled to occur on or before November 7, 2022, at a date, time, and location to be mutually agreed upon by the Company and the Seller.
Asset Purchase and Sale Agreement - Two
On October 4, 2022, the Company entered into a second Asset Purchase and Sale Agreement with Bushnell Pharmacy LLC, a Florida limited liability company. This agreement entails the Company's acquisition of certain assets currently utilized in Seller Two's pharmacy located at 1304 Golden Gate Drive, Southlake, TX 76092.
The agreed-upon purchase price under the APA Two is $2,250,000, which includes an inventory value of $550,000, RX Data value of $1,690,000, and a non-compete contribution from the member valued at $10,000. The closing of the transaction is not conditioned upon the completion of any due diligence process.
The closing of the transactions outlined in the APA Two is scheduled to occur on or before November 7, 2022, at a date, time, and location to be mutually agreed.
On January 18, 2023, Golden Developing Solutions, Inc. announced the completion of the conversion and removal of 320 million shares of its common stock.
According to an unaudited report, Golden Developing Solutions Inc. achieved sales of $5,658,865.07 in December 2022. The company is still in the process of onboarding its largest customer, which is expected to further contribute to its revenue. With this addition, the company anticipates reaching its targeted run rate based on the acquisitions made.
The company also expects a significant increase in revenues once the four previously announced acquisitions are fully transitioned. Once the transition is completed, Golden Developing Solutions Inc. plans to pursue additional acquisitions in the Specialty Pharmacy market, which is anticipated to further boost its revenues and help achieve its goals for 2023.
Stavros Triant, CEO of DVLP, mentioned that they are delaying the closure of several targeted additional acquisitions until the completion of state, federal, vendor, and other regulatory requirements and transitions related to the four acquisitions already made. The audit work on these acquisitions had faced some delays due to third-party proprietary software reporting systems. The necessary measures will be taken to ensure the completion of these processes, including allowing additional time if needed.
Emergent Health Corp. (OTC: EMGE) specializes in curating, developing, and marketing products within the realm of Regenerative Health. Their product range includes ingestibles and topicals suitable for individuals of all ages. The company employs online distribution channels and leverages Influencers' Content Based Shopping approach to promote their products across the United States and internationally. Under its subsidiaries, PharmaZu focuses on serving the Pet Community by providing e-commerce products and services, including Pet Pharmacy, Vet Telehealth, and Pet Wellness, utilizing Influencers and their content. Regen BioWellness acts as a distributor for various plant-based and regenerative medical products. Meanwhile, Evolutionary Biologics is a groundbreaking biologics company with a mission to deliver advanced regenerative products to the medical community. It is important to note that Emergent does not make any claims about FDA approval for diagnosing, treating, curing, or preventing diseases with their products.
Back on January 3, 2023, Emergent Health Corp. announced that its subsidiary, PharmaZu, Inc. ("PharmaZu"), a dedicated e-commerce provider of products and services focused on pet pharmacy, vet telehealth, and pet wellness, has successfully launched its e-commerce online platform. This move allows PharmaZu to enter the estimated $8.5 billion-dollar online pet medicine industry.
The regional markets for pet medicine, with a combined market size of US$32.2 billion in 2020, are projected to grow to a size of US$51.3 billion by 2026. Notably, China is expected to be one of the fastest-growing markets within this cluster of regional markets. The Asia-Pacific market, led by countries such as Australia, India, and South Korea, is forecasted to reach a value of US$4.2 billion by 2026. Similarly, Latin America is projected to experience a 6.8% compound annual growth rate (CAGR) throughout the analysis period.
Following that update, Emergent Health Corp. made an announcement on May 4, 2023 regarding a significant financial development. The company has entered into a Term Sheet for a firm committed underwriting with a nationally recognized investment banking firm, securing $10,000,000 for planned corporate financing transactions. These transactions include the private placement of securities (pre-IPO financings) as well as a planned $10 million initial public offering (IPO) of common stock for Emergent's subsidiary, PharmaZu.
The intention is to list PharmaZu's common stock on either the NASDAQ or NYSE/AMEX exchanges, ensuring there is no dilution to Emergent shareholders. Once the IPO becomes effective and the listing on a national exchange is established, PharmaZu intends to acquire a compounding pharmacy authorized in 48 states, situated in West Palm Beach, FL. This compounding pharmacy generates approximately $10 million in annual revenue and will serve as the backbone and fulfillment center for PharmaZu, facilitating the creation of a nationwide platform across the United States.
Following these developments, Emergent plans to distribute shares of PharmaZu to its shareholders as a dividend in a pro rata manner. This distribution will allow Emergent shareholders to benefit from their ownership in both Emergent Health Corp. and its subsidiary, PharmaZu.
Not long after that announcement, Emergent Health Corp. announced its collaboration with Apollo Biowellness, Inc., on May 23, 2023, which is a company engaged by Boustead to conduct an initial public offering (IPO) for the roll-up of the regenerative medicine space. This collaboration builds upon the previous announcement made by Emergent on May 18, 2023. Apollo Biowellness functions as an aggregate of manufacturing, distribution, and marketing within the regenerative space, focusing on regenerative products and brands.
The partnership between Emergent Health Corp. and Apollo Biowellness, along with the previously announced spin-off of PharmaZu, is expected to generate significant value for Emergent. As part of the roll-up facilitated by Boustead and Apollo Biowellness, effective June 1, 2023, Mr. Morrison will assume the position of President/CEO of Apollo Biowellness. He will also maintain his role as a member of the Board of Directors of Emergent, assuming the title of Chairman of the Board. Mr. Morrison will remain closely involved with Emergent, overseeing the ongoing development, marketing, and distribution of its products and brands. The two companies will coordinate their marketing strategies, collaborate on manufacturing processes, and work together to expand their range of products and brands.
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