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Yes Yes
Thank you.
My thoughts after watching Munaf Ali presentation of the Phoenix Story:
WORLD DIGITAL MINING SUMMIT 2021
Mining and Investment Summit 2020
USA Becoming the Cryptomining Hotspot for the World, as Miners Move Operations to North America
VANCOUVER – USA News Group – In a small Texas town of only 5,600 people, a territorial battle is being waged over what is likely set to be the Bitcoin (BTC) mining capital of the world. The combatants are none other than Bitdeer (a spin-off of Chinese bitcoin mining giant Bitmain), and Riot Blockchain, Inc. (NASDAQ:RIOT), both jostling over market share and positioning within an area of cheap electricity, in a building formerly occupied by Alcoa. Ever since China put a halt to crypto activities within its borders, focus is being given to operations in North America, making the US now the official top destination for miners, including Dogecoin (DOGE) miner and livestreaming platform Hello Pal International Inc. (CSE:HP) (OTC:HLLPF), as well as BTC miners BIT Digital (NASDAQ:BTBT), Bitfarms (NASDAQ:BITF), and Greenidge Generation Holdings Inc. (NASDAQ:GREE).
Headquartered in Vancouver, Canada, Hello Pal International Inc. (CSE:HP) (OTC:HLLPF) recently announced the relocation of its crypto mining rigs to North America. The move came after strategic search for secure new locations for their newly acquired ASIC miners.
Hello Pal is set to re-house their Bitmain Antminer L7 Machines which are ranked among the Top 5 most profitable miners and are the most profitable DOGE miner on available.
"We expect that the relocation of our mining operations to North America will set us up for long term stability in our crypto-mining operations,” said KL Wong, Founder and Chairman of Hello Pal. “In turn, this will provide us a solid base to execute our plans of integrating crypto into our social networking core business."
A thorough review of optimal global mining locations led Hello Pal and their partners Shanghai Yitang Data to decide upon moving most of their rigs in New York State, where all locations are set to use clean renewable energy (hydro-powered).
Each of the new mining rigs will be shipped directly to the NY facilities by Bitmain, which is expected to be in November and/or December this year. Hello Pal is also continuing to sell its existing Antminer L3+ mining rigs in China and using the proceeds to purchase brand new Antminer L7 models, which will be housed in North America.
The announcement came within a week of Hello Pal announcing record quarterly revenues, the majority of which came from cryptocurrency mining.
"We are very pleased to see the progress we have made as a Company, and believe that the results are evident in the financial figures," said Wong. "We are particularly excited in the continued internationalization of our business, as reflected in our expansion of livestreaming services outside China and the integration of cryptocurrency into our platform through our newly launched crypto-mining operations."
Meanwhile, down in Texas at its Whinstone Facility, Riot Blockchain, Inc. (NASDAQ:RIOT) recently announced its October 2021 production of 464 BTC—an ~433% increase over its 87 BTC production in October 2020.
So far in 2021, Riot has stated its year-to-date production total being 2,921 BTC—representing an increase of approximately 257% over its BTC production during the same period in 2020 which yielded 818 BTC.
The miner recently completed a $54 million purchase order with Bitmain (the same company that spun out its neighbors Bitdeer) for 9,000 S19j Pro (100 TH/s) miners, that are expected to be delivered May 2022 through October 2022. Shipments of 11,500 S19J Pro Antminers under previous purchase orders are also expected to be shipped to Riot’s Whinstone facility in November 2021.
Also awaiting new miners is BIT Digital (NASDAQ:BTBT), which in October announced an agreement to buy 10,000 machines from Bitmain. The announced purchases are expected to increase Bit Digital's miner fleet hash rate by over 1.0 Exahash ("EH/s").
"By contracting for these Bitmain units, we have opened a new channel in our procurement strategy, diversifying our access to miners,” said Bryan Bullett, CEO of Bit Digital. “While we believe we continue to enjoy differentiated access to the miner spot market, and expect to continue our ongoing spot purchases, our deal with Bitmain is an efficient means to procure a large quantum of new miners on attractive terms. This is key, as we believe that scale is paramount in importance in the bitcoin mining business."
There’s not only a race for machines, but also for power. Bitfarms (NASDAQ:BITF) recently announced the acquisition of 24 Megawatts (MW) of Hydro Power in Washington State, USA, and its entering into a memorandum of understanding (MOU) to expand that up to 99MW.
The announcement marks the first entry of Bitfarms into the United Statess, as the Ontario-based company plans to house approximately 6,200 Bitmain S19j Pro miners in the facility.
“The Washington farm meets all these criteria,” said Emiliano Grodzki, CEO of Bitfarms. “With this acquisition, we enter the United States and continue our global expansion to 10 farms in operation or under development in four countries. The initial 24 MW acquisition will increase our total mining capacity to 106 MW and boost our total hashrate as additional miners are installed.”
Not to be outdone in the race to make good business relations with Bitmain, Greenidge Generation Holdings Inc. (NASDAQ:GREE) recently announced a deal to be the initial global launch customer for the state-of-the-art ANTMINER S19 XP, which is said to be approximately 27% more efficient than any BTC mining technology currently available.
"We are excited to be chosen as a launch partner for this latest release from Bitmain," said Greenidge's CEO Jeff Kirt. "The ANTMINER S19 XP demonstrates a step-function increase in efficiency for our industry, and we are excited to deploy this next generation technology at one of our 100% carbon-neutral facilities."
The ANTMINER S19 XP has 21.5 joules/TH of efficiency compared to Bitmain's previous S19 Pro technology of 29.5 J/TH. The units will consume 27% less energy per terahash and will deliver 37% more computing power per kilowatt hour than current technology. The order is set to be delivered in Q3 2022, after which Greenidge intends to deploy them to a facility to be developed either in South Carolina or Texas.
https://www.baystreet.ca/articles/stockstowatch/72659/USA-Becoming-the-Cryptomining-Hotspot-for-the-World-as-Miners-Move-Operations-to-North-America
MENA to hold 10 percent of global crypto hash power
Phoenix has been granted approval to build and develop a large scale mining farm in the UAE.
November 22, 2021
Crypto miners bring more than $230 million into the economy of Kazakhstan each year and estimates show this figure could increase significantly in the future. Countries such as Kazakhstan have realized that the crypto mining industry and crypto hash power has the potential to pour over US $1.5 billion into the nation’s economy over a five year period. As such it is no surprise that the UAE is opening up its doors to the crypto economy and with it opening up to crypto mining.
As a result, UAE based Phoenix Technology, a cryptocurrency mining hardware reseller and hosting provider signed one of the world’s largest purchases on record for crypto mining rigs, worth US $650 million.
The purchase announcement was made during the World Digital Mining Summit in Dubai UAE by CEO and Co-Founder of Phoenix Technology Mr. Munaf Ali. UNLOCK interviewed Mr. Ali to learn more.
Munaf Ali explained to UNLOCK, “This is just the beginning, so far we have made a purchase of the latest mining rigs from Bitmain. These are the latest generation mining machines which come with the AntBox, mining container, which comes with a new built in water cooling solution that utilizes water cooling making it ideal for countries such as the UAE and the rest of the GCC. All the mining rigs we just purchased will be deployed in our UAE crypto mining farm.”
According to Munaf Ali, Phoenix has been granted approval to build and develop a large scale mining farm in the UAE. He explains, “Given that the UAE is a crypto friendly place, we were given a green light to setup up a crypto mining farm. We were offered attractive energy prices and have applied for the needed crypto licenses to build a large scale crypto mining farm. This is an optimal location for us given that the UAE has been my home for more than 17 years and we have solved the heat issue.”
Historically the founders of Phoenix both Munaf Ali and Bijan Alizadeh started their first Ethereum mining farm in the UAE in 2015, but had to expand to other jurisdictions because of the extreme hot summers. Munaf Ali explained, “So in 2015, we started off in the UAE with our GPU mining farm which produced Ethereum and it was going very well with 2 Megawatts, until the summer time hit. Our equipment started to suffer, chips were burning, so we had to look into other cooler locations that had cheap electricity and were crypto friendly. This brought us into Canada, Russia and most recently the USA, and now we are coming full circle back to the UAE, our home, setting up our mining operations in the UAE as phase one and then other jurisdictions in the MENA region in phase two.”
Munaf Ali is a big believer in crypto and crypto mining and the investment being made is based on the fact that adoption is increasing and will continue to do so. He points out, “Large scale institutions are getting involved in the crypto and crypto mining space whether they are insurance entities, financial, investment banks on Wall Street or mutual or hedge fund managers. They are seeking to generate income while getting exposure to a new asset class. Even mass adoption is increasing, so today let’s say 10 percent of world population knows about crypto and 10 percent of those are dabbling in crypto that means only 1 percent penetration of the world’s population is in crypto, what happens when 10 percent become involved or later on 20 percent? It will be big once it starts going mainstream, and it is already starting with the like of credit card companies, banks, retailers and others.”
In the future, Phoenix Technology is seeking to establish a large scale crypto exchange in the region to bring crypto to the fingertips of every person in the Middle East.
In conclusion crypto mining is considered one of the safest ways to invest in the crypto market, as it is not as volatile as crypto itself, the mining equipment retain a value and can be resold while generating an income stream. The UAE and MENA region can become the new crypto mining hub with the investments being made by companies such as Phoenix.
VISIONARY
Enough Said!
Munaf Ali is a Dubai-British-based finance manager, most popular as a Hotel business visionary. He is the CEO of Phoenix Store-Official Bitman Distributor. Munaf, the proprietor of the UAE display area. He has been centered around web-based media.
Munaf Ali is hitched to the Real Housewives of Dubai cast part Nina Ali. Nina Ali is a super powerhouse who moved to Dubai for her adoration, her better half, a British finance manager Munaf Ali. Nina Ali’s Husband Munaf Ali is a British Businessman, who is right now filling in as CEO of the Phoenix store.
Phoenix Store, an elite deals accomplice of Bitmain in the Middle East, is one of the main digital currency mining equipment retailers. Its maintenance community is situated in Dubai, United Arab Emirates, and claims its locales. Through his organization, they give advising on buying mining machines by means of their accomplished tea and investigate service contract bundles.
Further, they give facilitating and cooling administrations. Being the CEO of the organization, Munaf needs to redesign his customers with the most recent age mining hardware at the most cutthroat costs. Munaf Ali is right now at 47 years old, may have a total assets of $1 Billion.
Munaf Ali, the CEO at Range Hospitality, may be an extremely rich person or tycoon. Being the CEO of Phoenix and engaging in digital currency, the financial specialist tackle the stock of cash and bitcoins.
The financial specialist has extraordinary information on speculation and the offer market. Ali should be carrying on with an extravagant way of life alongside his wonderful spouse and his children.
Thank you.
Is there a 10Q past due?
Actually it is January 26, 2022.
My countdown numbers may be a few days off.
T-Minus 41
RGBP Current Status
One of two(2) things will happen:
1. RGBP will raise the 50 Million.
2. RGBP won't raise the 50 Million.
Other than as to confidentiality and good faith provisions of the LOI the parties agree that the LOI does not constitute a binding commitment by either party with respect to any transaction. The non-binding provisions of the LOI reflect only the parties’ current understanding of the contemplated transaction, and a binding contract will not exist between the Parties unless and until they sign and deliver a mutually acceptable definitive agreement. Other than to impose a duty to the parties to negotiate in good faith and to not disclose Confidential Information, no obligations of one party to the other or liability of any kind shall arise from executing this Letter or its taking or refraining from taking any actions relating to the proposed transaction.
Who are the Parties involved?
Proposal regarding contemplated acquisition of 95% of the share capital and voting power of Canary Oncoceutics, Inc (“Canary”) by Regen Biopharma, Inc. (“RGBP”) from Canary Oncoceutics Partners, LLC (“LLC”). RGBP, Canary, and LLC may be referred to as Party or collectively as Parties
What do RGBP propose to accomplish?
The management of the Company believes that the proposed acquisition of 95% of Canary would provide an opportunity for the Company to diversify its intellectual property portfolio beyond the development of therapeutics into the development of in vitro diagnostics specifically the development of complimentary functional precision medicine tests. In the event that intellectual property contemplated as being included in any definitive agreement can be successfully developed cancer patients could receive both a genetic test and a functional test. This combined test would provide their treating physician with information that will allow for the selection of the ideal drug/drug combination for each patient.
Some highlights from the “LOI”:
1. Definitions.
Net Sales shall be defined as the aggregate sum of all gross invoice prices of, plus the fair market the value of any non-cash consideration received from third party customers for Test Products or Test Services sold or leased by RGBP in the applicable territory, less (b) the aggregate sum of the following actual and customary deductions, where applicable and separately listed and in each case not otherwise reimbursed to the invoicing entity: (i) cash, trade, or quantity discounts; (ii) sales, use, VAT, tariff, import/export duties or other excise taxes imposed on particular sales (except for income taxes imposed on the sales of Test Product); (iii) transportation handling, or insurance charges; (iv) credits to customers because of billing errors, chargebacks, coupons, rebates, recalls, refunds, rejections, retroactive price adjustments, or returns; plus (v) any amounts invoiced that are not collected by RGBP after reasonable collection efforts subject to a cap of 3% of Net Sales.
Test Product shall be defined as a Patient-Derived Organoid on Vascular Net (PDOV) for a specific tumor type. For example, a colon tumor-derived PDOV is one Test Product, an ovarian tumor-derived PDOV is another Test Product.
Test Service shall be defined as any service performed by RGBP for the benefit of a third party that, in whole or in part, uses Test Product(s) or that practices or is enabled by a Test Product.
Territory shall be defined as Worldwide
3. Financing
No definitive agreement between the parties for the acquisition by RGBP of the Canary Controlling Interest shall close unless RGBP shall have raised the amount of $50,000,000 USD dedicated solely to the development and commercialization of Canary diagnostics and products (“Canary Funds”). The Canary Funds shall be deposited in a segregated account established solely for that purpose and disbursement of the Canary Funds shall be under the joint control of the Chairman and Chief Executive officer of RGBP and the Chief Executive Officer of Canary.
5. Term and Good Faith
(a) In consideration hereof and of the time and resources that RGBP will devote to the various investigations and reviews undertaken by RGBP, it is agreed by the Parties that Canary, LLC and each of their respective affiliates, directors, officers, employees, representatives and agents will not, directly or indirectly, solicit, initiate, enter into or continue any discussions or transactions with, or encourage, or provide any information to any person or entity with respect to any proposal pursuant to which (i) Canary would obtain any debt or equity capital or (ii) Canary would be acquired, whether through a purchase, acquisition, tender offer, consolidation or other business combination or (ii) either of Canary or LLC would enter into any transaction or arrangement or otherwise approve any transaction which would result in any third party acquiring any of the outstanding equity of Canary or (iii) Canary or LLC would license, sell or in any manner encumber any of the intellectual property of Canary between the date of execution by them of this LOI and the date ending 90 days thereafter ( “Term”).
(b) The Parties agree to negotiate in good faith to enter into a mutually acceptable definitive agreement with regard to the subject matter contemplated by this Letter until the completion of the Term (1/26/2022).
9. Intellectual Property
It is understood that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii. The final IP will be included in the definitive agreement as an appendix. This IP allows for the creation of patient-derived tumor on vascular nets for in vitro testing of therapeutic agents.
https://sec.report/Document/0001607062-21-000512/
Analysis and Thoughts:
The LOI is the ROADMAP to the Definitive Agreement. The LOI was probably negotiated over a period of several weeks and was probably in negotiations when RGBP provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property .
The LOI is very specific to what are each party’s rights and obligations. What is very encouraging is the detailed expected milestones, partnerships, FDA, EMA and PDMA approvals. Also the purchase price, fees, milestones payments are very precise as to the reason, time and amount.
One of the most intriguing and interesting pieces of the LOI is that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii.
While there is no guarantee this will succeed, the LOI was well thought out, negotiated with precision and detail which suggests an increase probability of a successful Definitive Agreement.
If an agreement is reached, it will mean that the 50 million was raised, due diligence completed and RGBP will be off to the races.
We will only find out about it after it happens and there is a very, very strong possibility that the stock price makes a major move and people will be falling all over themselves chasing it.
The question is will it be before or after Christmas?
Do you have proof that Koos own Canary.
That is news to me.
How do you figure Koos is negotiating with himself?
The stock PRICE absolutely means nothing at this point in time.
What ONLY matters at this point in time is will the 50 Million be raised.
T Minus 44 or sooner.
RGBP Current Status
One of two(2) things will happen:
1. RGBP will raise the 50 Million.
2. RGBP won't raise the 50 Million.
Other than as to confidentiality and good faith provisions of the LOI the parties agree that the LOI does not constitute a binding commitment by either party with respect to any transaction. The non-binding provisions of the LOI reflect only the parties’ current understanding of the contemplated transaction, and a binding contract will not exist between the Parties unless and until they sign and deliver a mutually acceptable definitive agreement. Other than to impose a duty to the parties to negotiate in good faith and to not disclose Confidential Information, no obligations of one party to the other or liability of any kind shall arise from executing this Letter or its taking or refraining from taking any actions relating to the proposed transaction.
Who are the Parties involved?
Proposal regarding contemplated acquisition of 95% of the share capital and voting power of Canary Oncoceutics, Inc (“Canary”) by Regen Biopharma, Inc. (“RGBP”) from Canary Oncoceutics Partners, LLC (“LLC”). RGBP, Canary, and LLC may be referred to as Party or collectively as Parties
What do RGBP propose to accomplish?
The management of the Company believes that the proposed acquisition of 95% of Canary would provide an opportunity for the Company to diversify its intellectual property portfolio beyond the development of therapeutics into the development of in vitro diagnostics specifically the development of complimentary functional precision medicine tests. In the event that intellectual property contemplated as being included in any definitive agreement can be successfully developed cancer patients could receive both a genetic test and a functional test. This combined test would provide their treating physician with information that will allow for the selection of the ideal drug/drug combination for each patient.
Some highlights from the “LOI”:
1. Definitions.
Net Sales shall be defined as the aggregate sum of all gross invoice prices of, plus the fair market the value of any non-cash consideration received from third party customers for Test Products or Test Services sold or leased by RGBP in the applicable territory, less (b) the aggregate sum of the following actual and customary deductions, where applicable and separately listed and in each case not otherwise reimbursed to the invoicing entity: (i) cash, trade, or quantity discounts; (ii) sales, use, VAT, tariff, import/export duties or other excise taxes imposed on particular sales (except for income taxes imposed on the sales of Test Product); (iii) transportation handling, or insurance charges; (iv) credits to customers because of billing errors, chargebacks, coupons, rebates, recalls, refunds, rejections, retroactive price adjustments, or returns; plus (v) any amounts invoiced that are not collected by RGBP after reasonable collection efforts subject to a cap of 3% of Net Sales.
Test Product shall be defined as a Patient-Derived Organoid on Vascular Net (PDOV) for a specific tumor type. For example, a colon tumor-derived PDOV is one Test Product, an ovarian tumor-derived PDOV is another Test Product.
Test Service shall be defined as any service performed by RGBP for the benefit of a third party that, in whole or in part, uses Test Product(s) or that practices or is enabled by a Test Product.
Territory shall be defined as Worldwide
3. Financing
No definitive agreement between the parties for the acquisition by RGBP of the Canary Controlling Interest shall close unless RGBP shall have raised the amount of $50,000,000 USD dedicated solely to the development and commercialization of Canary diagnostics and products (“Canary Funds”). The Canary Funds shall be deposited in a segregated account established solely for that purpose and disbursement of the Canary Funds shall be under the joint control of the Chairman and Chief Executive officer of RGBP and the Chief Executive Officer of Canary.
5. Term and Good Faith
(a) In consideration hereof and of the time and resources that RGBP will devote to the various investigations and reviews undertaken by RGBP, it is agreed by the Parties that Canary, LLC and each of their respective affiliates, directors, officers, employees, representatives and agents will not, directly or indirectly, solicit, initiate, enter into or continue any discussions or transactions with, or encourage, or provide any information to any person or entity with respect to any proposal pursuant to which (i) Canary would obtain any debt or equity capital or (ii) Canary would be acquired, whether through a purchase, acquisition, tender offer, consolidation or other business combination or (ii) either of Canary or LLC would enter into any transaction or arrangement or otherwise approve any transaction which would result in any third party acquiring any of the outstanding equity of Canary or (iii) Canary or LLC would license, sell or in any manner encumber any of the intellectual property of Canary between the date of execution by them of this LOI and the date ending 90 days thereafter ( “Term”).
(b) The Parties agree to negotiate in good faith to enter into a mutually acceptable definitive agreement with regard to the subject matter contemplated by this Letter until the completion of the Term (1/26/2022).
9. Intellectual Property
It is understood that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii. The final IP will be included in the definitive agreement as an appendix. This IP allows for the creation of patient-derived tumor on vascular nets for in vitro testing of therapeutic agents.
https://sec.report/Document/0001607062-21-000512/
Analysis and Thoughts:
The LOI is the ROADMAP to the Definitive Agreement. The LOI was probably negotiated over a period of several weeks and was probably in negotiations when RGBP provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property .
The LOI is very specific to what are each party’s rights and obligations. What is very encouraging is the detailed expected milestones, partnerships, FDA, EMA and PDMA approvals. Also the purchase price, fees, milestones payments are very precise as to the reason, time and amount.
One of the most intriguing and interesting pieces of the LOI is that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii.
While there is no guarantee this will succeed, the LOI was well thought out, negotiated with precision and detail which suggests an increase probability of a successful Definitive Agreement.
If an agreement is reached, it will mean that the 50 million was raised, due diligence completed and RGBP will be off to the races.
We will only find out about it after it happens and there is a very, very strong possibility that the stock price makes a major move and people will be falling all over themselves chasing it.
The question is will it be before or after Christmas?
The stock PRICE absolutely means nothing at this point in time.
What ONLY matters at this point in time is will the 50 Million be raised.
T Minus 54 or sooner.
RGBP Current Status
One of two(2) things will happen:
1. RGBP will raise the 50 Million.
2. RGBP won't raise the 50 Million.
Other than as to confidentiality and good faith provisions of the LOI the parties agree that the LOI does not constitute a binding commitment by either party with respect to any transaction. The non-binding provisions of the LOI reflect only the parties’ current understanding of the contemplated transaction, and a binding contract will not exist between the Parties unless and until they sign and deliver a mutually acceptable definitive agreement. Other than to impose a duty to the parties to negotiate in good faith and to not disclose Confidential Information, no obligations of one party to the other or liability of any kind shall arise from executing this Letter or its taking or refraining from taking any actions relating to the proposed transaction.
Who are the Parties involved?
Proposal regarding contemplated acquisition of 95% of the share capital and voting power of Canary Oncoceutics, Inc (“Canary”) by Regen Biopharma, Inc. (“RGBP”) from Canary Oncoceutics Partners, LLC (“LLC”). RGBP, Canary, and LLC may be referred to as Party or collectively as Parties
What do RGBP propose to accomplish?
The management of the Company believes that the proposed acquisition of 95% of Canary would provide an opportunity for the Company to diversify its intellectual property portfolio beyond the development of therapeutics into the development of in vitro diagnostics specifically the development of complimentary functional precision medicine tests. In the event that intellectual property contemplated as being included in any definitive agreement can be successfully developed cancer patients could receive both a genetic test and a functional test. This combined test would provide their treating physician with information that will allow for the selection of the ideal drug/drug combination for each patient.
Some highlights from the “LOI”:
1. Definitions.
Net Sales shall be defined as the aggregate sum of all gross invoice prices of, plus the fair market the value of any non-cash consideration received from third party customers for Test Products or Test Services sold or leased by RGBP in the applicable territory, less (b) the aggregate sum of the following actual and customary deductions, where applicable and separately listed and in each case not otherwise reimbursed to the invoicing entity: (i) cash, trade, or quantity discounts; (ii) sales, use, VAT, tariff, import/export duties or other excise taxes imposed on particular sales (except for income taxes imposed on the sales of Test Product); (iii) transportation handling, or insurance charges; (iv) credits to customers because of billing errors, chargebacks, coupons, rebates, recalls, refunds, rejections, retroactive price adjustments, or returns; plus (v) any amounts invoiced that are not collected by RGBP after reasonable collection efforts subject to a cap of 3% of Net Sales.
Test Product shall be defined as a Patient-Derived Organoid on Vascular Net (PDOV) for a specific tumor type. For example, a colon tumor-derived PDOV is one Test Product, an ovarian tumor-derived PDOV is another Test Product.
Test Service shall be defined as any service performed by RGBP for the benefit of a third party that, in whole or in part, uses Test Product(s) or that practices or is enabled by a Test Product.
Territory shall be defined as Worldwide
3. Financing
No definitive agreement between the parties for the acquisition by RGBP of the Canary Controlling Interest shall close unless RGBP shall have raised the amount of $50,000,000 USD dedicated solely to the development and commercialization of Canary diagnostics and products (“Canary Funds”). The Canary Funds shall be deposited in a segregated account established solely for that purpose and disbursement of the Canary Funds shall be under the joint control of the Chairman and Chief Executive officer of RGBP and the Chief Executive Officer of Canary.
5. Term and Good Faith
(a) In consideration hereof and of the time and resources that RGBP will devote to the various investigations and reviews undertaken by RGBP, it is agreed by the Parties that Canary, LLC and each of their respective affiliates, directors, officers, employees, representatives and agents will not, directly or indirectly, solicit, initiate, enter into or continue any discussions or transactions with, or encourage, or provide any information to any person or entity with respect to any proposal pursuant to which (i) Canary would obtain any debt or equity capital or (ii) Canary would be acquired, whether through a purchase, acquisition, tender offer, consolidation or other business combination or (ii) either of Canary or LLC would enter into any transaction or arrangement or otherwise approve any transaction which would result in any third party acquiring any of the outstanding equity of Canary or (iii) Canary or LLC would license, sell or in any manner encumber any of the intellectual property of Canary between the date of execution by them of this LOI and the date ending 90 days thereafter ( “Term”).
(b) The Parties agree to negotiate in good faith to enter into a mutually acceptable definitive agreement with regard to the subject matter contemplated by this Letter until the completion of the Term (1/26/2022).
9. Intellectual Property
It is understood that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii. The final IP will be included in the definitive agreement as an appendix. This IP allows for the creation of patient-derived tumor on vascular nets for in vitro testing of therapeutic agents.
https://sec.report/Document/0001607062-21-000512/
Analysis and Thoughts:
The LOI is the ROADMAP to the Definitive Agreement. The LOI was probably negotiated over a period of several weeks and was probably in negotiations when RGBP provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property .
The LOI is very specific to what are each party’s rights and obligations. What is very encouraging is the detailed expected milestones, partnerships, FDA, EMA and PDMA approvals. Also the purchase price, fees, milestones payments are very precise as to the reason, time and amount.
One of the most intriguing and interesting pieces of the LOI is that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii.
While there is no guarantee this will succeed, the LOI was well thought out, negotiated with precision and detail which suggests an increase probability of a successful Definitive Agreement.
If an agreement is reached, it will mean that the 50 million was raised, due diligence completed and RGBP will be off to the races.
We will only find out about it after it happens and there is a very, very strong possibility that the stock price makes a major move and people will be falling all over themselves chasing it.
The question is will it be before or after Christmas?
The stock PRICE absolutely means nothing at this point in time.
What ONLY matters at this point in time is will the 50 Million be raised.
T Minus 55 or sooner.
RGBP Current Status
One of two(2) things will happen:
1. RGBP will raise the 50 Million.
2. RGBP won't raise the 50 Million.
Other than as to confidentiality and good faith provisions of the LOI the parties agree that the LOI does not constitute a binding commitment by either party with respect to any transaction. The non-binding provisions of the LOI reflect only the parties’ current understanding of the contemplated transaction, and a binding contract will not exist between the Parties unless and until they sign and deliver a mutually acceptable definitive agreement. Other than to impose a duty to the parties to negotiate in good faith and to not disclose Confidential Information, no obligations of one party to the other or liability of any kind shall arise from executing this Letter or its taking or refraining from taking any actions relating to the proposed transaction.
Who are the Parties involved?
Proposal regarding contemplated acquisition of 95% of the share capital and voting power of Canary Oncoceutics, Inc (“Canary”) by Regen Biopharma, Inc. (“RGBP”) from Canary Oncoceutics Partners, LLC (“LLC”). RGBP, Canary, and LLC may be referred to as Party or collectively as Parties
What do RGBP propose to accomplish?
The management of the Company believes that the proposed acquisition of 95% of Canary would provide an opportunity for the Company to diversify its intellectual property portfolio beyond the development of therapeutics into the development of in vitro diagnostics specifically the development of complimentary functional precision medicine tests. In the event that intellectual property contemplated as being included in any definitive agreement can be successfully developed cancer patients could receive both a genetic test and a functional test. This combined test would provide their treating physician with information that will allow for the selection of the ideal drug/drug combination for each patient.
Some highlights from the “LOI”:
1. Definitions.
Net Sales shall be defined as the aggregate sum of all gross invoice prices of, plus the fair market the value of any non-cash consideration received from third party customers for Test Products or Test Services sold or leased by RGBP in the applicable territory, less (b) the aggregate sum of the following actual and customary deductions, where applicable and separately listed and in each case not otherwise reimbursed to the invoicing entity: (i) cash, trade, or quantity discounts; (ii) sales, use, VAT, tariff, import/export duties or other excise taxes imposed on particular sales (except for income taxes imposed on the sales of Test Product); (iii) transportation handling, or insurance charges; (iv) credits to customers because of billing errors, chargebacks, coupons, rebates, recalls, refunds, rejections, retroactive price adjustments, or returns; plus (v) any amounts invoiced that are not collected by RGBP after reasonable collection efforts subject to a cap of 3% of Net Sales.
Test Product shall be defined as a Patient-Derived Organoid on Vascular Net (PDOV) for a specific tumor type. For example, a colon tumor-derived PDOV is one Test Product, an ovarian tumor-derived PDOV is another Test Product.
Test Service shall be defined as any service performed by RGBP for the benefit of a third party that, in whole or in part, uses Test Product(s) or that practices or is enabled by a Test Product.
Territory shall be defined as Worldwide
3. Financing
No definitive agreement between the parties for the acquisition by RGBP of the Canary Controlling Interest shall close unless RGBP shall have raised the amount of $50,000,000 USD dedicated solely to the development and commercialization of Canary diagnostics and products (“Canary Funds”). The Canary Funds shall be deposited in a segregated account established solely for that purpose and disbursement of the Canary Funds shall be under the joint control of the Chairman and Chief Executive officer of RGBP and the Chief Executive Officer of Canary.
5. Term and Good Faith
(a) In consideration hereof and of the time and resources that RGBP will devote to the various investigations and reviews undertaken by RGBP, it is agreed by the Parties that Canary, LLC and each of their respective affiliates, directors, officers, employees, representatives and agents will not, directly or indirectly, solicit, initiate, enter into or continue any discussions or transactions with, or encourage, or provide any information to any person or entity with respect to any proposal pursuant to which (i) Canary would obtain any debt or equity capital or (ii) Canary would be acquired, whether through a purchase, acquisition, tender offer, consolidation or other business combination or (ii) either of Canary or LLC would enter into any transaction or arrangement or otherwise approve any transaction which would result in any third party acquiring any of the outstanding equity of Canary or (iii) Canary or LLC would license, sell or in any manner encumber any of the intellectual property of Canary between the date of execution by them of this LOI and the date ending 90 days thereafter ( “Term”).
(b) The Parties agree to negotiate in good faith to enter into a mutually acceptable definitive agreement with regard to the subject matter contemplated by this Letter until the completion of the Term (1/26/2022).
9. Intellectual Property
It is understood that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii. The final IP will be included in the definitive agreement as an appendix. This IP allows for the creation of patient-derived tumor on vascular nets for in vitro testing of therapeutic agents.
https://sec.report/Document/0001607062-21-000512/
Analysis and Thoughts:
The LOI is the ROADMAP to the Definitive Agreement. The LOI was probably negotiated over a period of several weeks and was probably in negotiations when RGBP provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property .
The LOI is very specific to what are each party’s rights and obligations. What is very encouraging is the detailed expected milestones, partnerships, FDA, EMA and PDMA approvals. Also the purchase price, fees, milestones payments are very precise as to the reason, time and amount.
One of the most intriguing and interesting pieces of the LOI is that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii.
While there is no guarantee this will succeed, the LOI was well thought out, negotiated with precision and detail which suggests an increase probability of a successful Definitive Agreement.
If an agreement is reached, it will mean that the 50 million was raised, due diligence completed and RGBP will be off to the races.
We will only find out about it after it happens and there is a very, very strong possibility that the stock price makes a major move and people will be falling all over themselves chasing it.
T minus 58.
Don't expect much from the CC unless the have updates on the testing they have been doing.
SOS
We have great plans to market our products.
SOS
FDA requires more testing.
SOS
Here is our CFO with an update.
Things will change for QNTA when the required FDA testing are completed and the IND gets moving along.
The key to QNTA is the Escozine and until they can sell that in good volume the stock price will suffer.
What we know:
There is a SEC formal investigation.
On August 5, 2021, the Company received notice the Securities and Exchange Commission had commenced on investigation related to the Company and affiliated persons and entities.
What we don't know:
The extent of the investigation.
Who are the affiliated persons and entities.
Background on SCE Investigations:
Origins of Enforcement Investigations
An SEC inspection can result in no findings of violations,
which is very rare; a deficiency letter, which sets forth the
SEC examiner’s findings of violations and demands the firm
take remedial measures; or a referral to the SEC Division of
Enforcement. Often, an enforcement referral comes after
the receipt of a deficiency letter. The SEC inspection staff
now works very closely with the enforcement staff, so it
should be assumed that the enforcement staff will be made
aware of all material violations found during inspections.
Origins of Enforcement Investigations
A second and increasingly common source of SEC investigations
is a report by a whistleblower. The Dodd-Frank Act greatly
expanded the SEC’s program to compensate whistleblowers who
report potential violations to the SEC. The SEC now receives
thousands of such whistleblower reports every year and has
awarded millions of dollars to whistleblowers who provide valuable
information to its enforcement program. However, only an
individual is eligible for a whistleblower award; a legal entity is not
eligible for compensation. A related initiative, the cooperation
initiative, has greatly expanded the credit the SEC gives to
individuals or legal entities that provide valuable information to
assist its enforcement program. In certain cases, “partially
culpable” whistleblowers have even received civil and sometimes
even criminal immunity from prosecution in exchange for their
assistance to the SEC.
Origins of Enforcement Investigations
A third common source of SEC investigations is press
reports. The SEC monitors the press for stories about
possible illegal conduct and refers interesting articles to its
enforcement attorneys for investigation. If a private fund
becomes aware of press reports suggesting illegal conduct,
the firm should assume that the SEC may follow up those
reports with an enforcement inquiry
Overview of SEC investigations
The SEC conducts two general types of investigations: informal
inquiries and formal investigations. The difference between these
two types of investigations depends upon whether the SEC staff
can compel witnesses to provide information by issuing
subpoenas for documents or testimony.
How long do SEC investigations usually take?
Typically, SEC investigations take two to four years to complete.
How many enforcement actions does the SEC take each year against securities law violators What are the typical infractions?
Each year the SEC brings between 400-500 civil enforcement actions against individuals and companies that break the securities laws. Typical infractions include insider trading, accounting fraud, and providing false or misleading information about securities and the companies that issue them.
Division of Enforcement 2020 Annual Report
https://www.sec.gov/files/enforcement-annual-report-2020.pdf
SEC Announces Enforcement Results for FY 2021
https://www.sec.gov/news/press-release/2021-238
Thoughts:
Any SEC investigation is not a good thing for any company.
Hopefully QNTA hired a SEC attorney to handle this matter.
It is hard to find solace in a SEC investigation however we can rest assure that if it was an egregious violation QNTA wouldn't be trading as it has been almost 4 months since the investigation begun.
Q due Today
That is a 50 million dollar question only the company can answer.
The LOI is very specific about what is to be done, who is to do it and where it is to be done.
The LOI appears to be the work of some very conscientious people with some specific goals in mind.
I trust that the 50 million was a given or being provided (angel funder) as the LOI was being developed.
It really doesn't matter who as long as it is provided.
RGBP Current Status as of the LOI Dated November 11, 2021
Other than as to confidentiality and good faith provisions of the LOI the parties agree that the LOI does not constitute a binding commitment by either party with respect to any transaction. The non-binding provisions of the LOI reflect only the parties’ current understanding of the contemplated transaction, and a binding contract will not exist between the Parties unless and until they sign and deliver a mutually acceptable definitive agreement. Other than to impose a duty to the parties to negotiate in good faith and to not disclose Confidential Information, no obligations of one party to the other or liability of any kind shall arise from executing this Letter or its taking or refraining from taking any actions relating to the proposed transaction.
Who are the Parties involved?
Proposal regarding contemplated acquisition of 95% of the share capital and voting power of Canary Oncoceutics, Inc (“Canary”) by Regen Biopharma, Inc. (“RGBP”) from Canary Oncoceutics Partners, LLC (“LLC”). RGBP, Canary, and LLC may be referred to as Party or collectively as Parties
What do RGBP propose to accomplish?
The management of the Company believes that the proposed acquisition of 95% of Canary would provide an opportunity for the Company to diversify its intellectual property portfolio beyond the development of therapeutics into the development of in vitro diagnostics specifically the development of complimentary functional precision medicine tests. In the event that intellectual property contemplated as being included in any definitive agreement can be successfully developed cancer patients could receive both a genetic test and a functional test. This combined test would provide their treating physician with information that will allow for the selection of the ideal drug/drug combination for each patient.
Some highlights from the “LOI”:
1. Definitions.
Net Sales shall be defined as the aggregate sum of all gross invoice prices of, plus the fair market the value of any non-cash consideration received from third party customers for Test Products or Test Services sold or leased by RGBP in the applicable territory, less (b) the aggregate sum of the following actual and customary deductions, where applicable and separately listed and in each case not otherwise reimbursed to the invoicing entity: (i) cash, trade, or quantity discounts; (ii) sales, use, VAT, tariff, import/export duties or other excise taxes imposed on particular sales (except for income taxes imposed on the sales of Test Product); (iii) transportation handling, or insurance charges; (iv) credits to customers because of billing errors, chargebacks, coupons, rebates, recalls, refunds, rejections, retroactive price adjustments, or returns; plus (v) any amounts invoiced that are not collected by RGBP after reasonable collection efforts subject to a cap of 3% of Net Sales.
Test Product shall be defined as a Patient-Derived Organoid on Vascular Net (PDOV) for a specific tumor type. For example, a colon tumor-derived PDOV is one Test Product, an ovarian tumor-derived PDOV is another Test Product.
Test Service shall be defined as any service performed by RGBP for the benefit of a third party that, in whole or in part, uses Test Product(s) or that practices or is enabled by a Test Product.
Territory shall be defined as Worldwide
3. Financing
No definitive agreement between the parties for the acquisition by RGBP of the Canary Controlling Interest shall close unless RGBP shall have raised the amount of $50,000,000 USD dedicated solely to the development and commercialization of Canary diagnostics and products (“Canary Funds”). The Canary Funds shall be deposited in a segregated account established solely for that purpose and disbursement of the Canary Funds shall be under the joint control of the Chairman and Chief Executive officer of RGBP and the Chief Executive Officer of Canary.
5. Term and Good Faith
(a) In consideration hereof and of the time and resources that RGBP will devote to the various investigations and reviews undertaken by RGBP, it is agreed by the Parties that Canary, LLC and each of their respective affiliates, directors, officers, employees, representatives and agents will not, directly or indirectly, solicit, initiate, enter into or continue any discussions or transactions with, or encourage, or provide any information to any person or entity with respect to any proposal pursuant to which (i) Canary would obtain any debt or equity capital or (ii) Canary would be acquired, whether through a purchase, acquisition, tender offer, consolidation or other business combination or (ii) either of Canary or LLC would enter into any transaction or arrangement or otherwise approve any transaction which would result in any third party acquiring any of the outstanding equity of Canary or (iii) Canary or LLC would license, sell or in any manner encumber any of the intellectual property of Canary between the date of execution by them of this LOI and the date ending 90 days thereafter ( “Term”).
(b) The Parties agree to negotiate in good faith to enter into a mutually acceptable definitive agreement with regard to the subject matter contemplated by this Letter until the completion of the Term (1/26/2022).
9. Intellectual Property
It is understood that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii. The final IP will be included in the definitive agreement as an appendix. This IP allows for the creation of patient-derived tumor on vascular nets for in vitro testing of therapeutic agents.
https://sec.report/Document/0001607062-21-000512/
Analysis and Thoughts:
The LOI is the ROADMAP to the Definitive Agreement. The LOI was probably negotiated over a period of several weeks and was probably in negotiations when RGBP provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property .
The LOI is very specific to what are each party’s rights and obligations. What is very encouraging is the detailed expected milestones, partnerships, FDA, EMA and PDMA approvals. Also the purchase price, fees, milestones payments are very precise as to the reason, time and amount.
One of the most intriguing and interesting pieces of the LOI is that the IP that will be licensed into Canary will originate from Cornell University and specifically from the laboratory of Dr. Shahin Rafii.
While there is no guarantee this will succeed, the LOI was well thought out, negotiated with precision and detail which suggests an increase probability of a successful Definitive Agreement.
If an agreement is reached, it will mean that the 50 million was raised, due diligence completed and RGBP will be off to the races.
We will only find out about it after it happens and there is a very, very strong possibility that the stock price makes a major move and people will be falling all over themselves chasing it.
T minus 82 days.
No it won't change next week.
It has already changed with the latest 8K.
On October 18, 2021 Regen Biopharma, Inc. (“Company”) has provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property . Total consideration to be paid by the Company to Biotech Research Group for providing these services is $25,000. The termination date of this Scope of Work Order is November 15, 2021.
BRG's Scope of Work order is a "moot point".
The 8K has laid out RGBP plans for the future:
On November 11,2021 Regen Biopharma, Inc. (the “Company”) entered into a Letter of Intent ( “LOI”) with Canary Oncoceutics, Inc (“Canary”) and Canary Oncoceutics Partners, LLC (“LLC”) whereby the Company shall acquire 95% of the share capital and voting power of Canary ( “Canary Controlling Interest”) for consideration consisting of $1,000,000 and common shares of the Company valued at the average share price of the common shares in the 2 weeks prior to the closing of a definitive agreement between the parties (“RGBP Share Value”). The number of common shares to be issued shall be the number of common shares valued at the RGBP share value which shall equal the value of the Canary Controlling Interest as determined by a mutually acceptable third-party valuation expert.
It is quite clear. the next catalyst on the agenda for RGBP is to raise $50,000,000 to get to an definitive agreement:
Me neither.
Has anyone found any information on Canary Oncoceutics, Inc?
On October 18, 2021 Regen Biopharma, Inc. (“Company”) has provided a Scope of Work order to Biotech Research Group directing Biotech Research Group to perform an independent assessment of work conducted to date on behalf of the Company by the Company’s Contract Research Organization in order to assist the Company in determining what would be the most efficient actions to undertake in order to commercialize the Company’s NR2F6 intellectual property as well as assist the Company with regulatory strategy with regard to the Company’s NR2F6 intellectual property . Total consideration to be paid by the Company to Biotech Research Group for providing these services is $25,000. The termination date of this Scope of Work Order is November 15, 2021.
Whether or not this is the result of the Scope of Work order is a "moot point".
RGBP has laid out its' plans for the future:
On November 11,2021 Regen Biopharma, Inc. (the “Company”) entered into a Letter of Intent ( “LOI”) with Canary Oncoceutics, Inc (“Canary”) and Canary Oncoceutics Partners, LLC (“LLC”) whereby the Company shall acquire 95% of the share capital and voting power of Canary ( “Canary Controlling Interest”) for consideration consisting of $1,000,000 and common shares of the Company valued at the average share price of the common shares in the 2 weeks prior to the closing of a definitive agreement between the parties (“RGBP Share Value”). The number of common shares to be issued shall be the number of common shares valued at the RGBP share value which shall equal the value of the Canary Controlling Interest as determined by a mutually acceptable third-party valuation expert.
It is quite clear. the next catalyst on the agenda for RGBP is to raise $50,000,000 to get to an definitive agreement:
Patient-Derived Tumor Xenograft (PDTX)
https://meyercancer.weill.cornell.edu/PDX
Cancer cures cannot come about without a way to test them. Early discoveries were made using cell lines grown in petri dishes. Later, these in vitro human cells were transplanted into mice for in vivo observation and testing.
Patient-Derived Tumor Xenografts (PDTX) take these tools to the next level.
Established from the transplantation of a fresh human tumor specimen from a cancer patient directly into a mouse, PDTX models preserve key features of a specific cancer such as invasiveness, desmoplastic reaction, tumor vasculature and cellular diversity. They more closely resemble human cancer and are easier to reproduce -- qualities that have led several institutions and health networks to create repositories of clinically-annotated cancer models derived from primary patient samples. The National Cancer Institute announced it is retiring its panel of 60 human cancer cell lines grown in culture from its drug screening program in favor of PDXs, fibroblasts and circulating tumor cells, and is launching Patient Derived Xenograft Development and Trial Centers (PDTCs) and Data networks.
The Meyer Cancer Center established a PDTX laboratory in 2014, with the objective to generate ad hoc models from cancer patients enrolled in our clinical programs or followed by our clinical oncologists. This repository of cancer cell models is also used by cancer center researchers to probe the mechanisms of cancer, advance drug discovery, test new anti-cancer compounds, and create innovative therapeutic strategies personalized to each patient.
The lab features several units, including a "surgical suite" with an MRI machine and metabolic profiling technology to rapidly measure responses to therapies, which can be key for applications in the clinical setting.
Led by hematopathologist Giorgio Inghirami, M.D., it is one of the only sites in the United States to feature PDTX models for T-cell lymphoma, and specializes in several other lymphoid malignancies.
Our institutional expertise in stem cell research and bone marrow transplantation also provides unique opportunities.
The Meyer Cancer Center PDTX program is also on the forefront in the generation of new models for genomic and pre-clinical functional studies and drug discovery programs, including organoids and tumoroid-based cultures.
In partnership with Houston Methodist, the Meyer Cancer Center program is able to provide access to more than 650 PDTX models across many tumor types.
Weill Cornell Medicine is also a member of the EuroPDX Consortium, enabling access for cancer center members to an additional 1,800 models.
Additional models may be available via PRoXe, the Public Repository of Xenografts.
Key Services
development of PDX models
advanced tumor monitoring and imaging
preclinical drug efficacy studies
tissue collection, preservation and banking
in vivo data management and analysis
RGBP plans to rapidly advance novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is advancing small molecule therapies for treating cancer and autoimmune disorders by modulating the Checkpoint NR2F6.
The company also developing products treating blood disorders using small molecules and gene silencing (DiffronC), treating cancer with cellular immunotherapy (dCellVax), modulating key molecular processes in cancer stem cell through its patented molecular targeting approaches (BORIS), and repairing damaged bone marrow in patients with aplastic anemia and chemotherapy/radiotherapy treated cancer patients (HemaXellerate). RGBP owns a valuable patent porfolio.
Key Word: small molecule
Why Small Molecules Are Still a Big Deal
Small molecules continue to play a role in innovative treatments for the four major indications that account for more than half of global pharma growth: oncology, diabetes, autoimmune, and respiratory diseases. For example, small molecule protein kinase inhibitors, of which the FDA has approved 48, are becoming more important in cancer therapy. Another area of growth entails the use of small and large molecules in combination; antibody drug conjugates (ADC), which couple potent small molecule payloads with the targeting capabilities of monoclonal antibodies, allowing for more precise treatment of cancer (and fewer side effects than standard chemotherapy).
Small companies are driving innovation. The vast majority of small molecule drugs in development are held by small or “emerging” companies with fewer than 100 employees. Our analysis suggests that these companies account for approximately 4,400 candidate compounds – or 70 percent of the small-molecule pipeline. These companies are increasingly bringing successful compounds to commercial production, and typically require access to enabling technologies, development, and manufacturing partners to do so.
In short, small molecules are still a big deal – and will be for the foreseeable future. CDMOs with specialized technologies and expertise will continue to help pharma companies advance their compounds. The ability to tailor services to specific customers and drug programs will play an increasingly important role in accelerating patient access to innovative drugs.
See the below link for entire article:
https://themedicinemaker.com/manufacture/why-small-molecules-are-still-a-big-deal
QNTA stock price will continue to bounce around until sales of goods stabilize and our FDA app gets approved.
I don't think it will hit a dollar until after QNTA gets the approval for the IND application which should be sooner than later.
There will always be runs however for QNTA to have a sustained upward movement it will take consistent solid results. They have built a great brand and have a solid footing in moving through the FDA bureaucracy.
QNTA built it and I'm hopeful results will come.
QNTA has a lot of things going on and until we see some results such as increased product sales or FDA approvals, the stock price will suffer.
ESCOZINE:
It is on a road trip with down the FDA freeway with detours along the way. However QNTA will reach their intended destination which is IND application approval.
Detour
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
Will there be more detours?
We will find out after QNTA submits the two addition toxicology studies.
We have people in our camp that should help to get us through the FDA approval process:
From today' s PR 11/1/2021:
In recent months, the Company has demonstrated tremendous progress in both its clinical development program as well as its direct-to-consumer nutraceutical product portfolio. It is in the process of completing a pharmacokinetic (PK) study on its lead drug candidate Escozine® per an instructional response from the US Food and Drug Administration (FDA) as it relates to the Company’s pre-Investigational New Drug (Pre-IND) application for Escozine®. Additionally, it has ramped up its sales and marketing initiatives on its consumer products including the attendance and sponsorship of the Tony Hawk Vert Alert event, where it showcased its revolutionary line of pain relief products and introduced its Immunapen™ line of products.
From August 3, 2021 PR:
The Company is performing a PK and a biodistribution study of Escozine® in rodents, which is being conducted by a laboratory in the United Kingdom. They are part of the requirements outlined by the FDA as next steps for the Company’s pre-IND application. The study is composed of two parts. The first part is conjugating Escozine®-containing peptides with radioactive iodine and performing a stability study of the conjugate in blood products. After the conjugation, the radioactive Escozine® will be injected sublingually into ten mice. Compared to intravenously injected mice following several time points, Escozine® levels will be determined in the blood and plasma of mice over 24 hours. Furthermore, imaging studies of mice will be performed to assess the biodistribution of Escozine in mice. These studies have several implications on the dose of Escozine®, blood-time profile, body clearance, and its biodistribution.
“An additional PK study is the next step in our FDA IND submission process and an important one as it will provide us with the data needed to formulate therapeutic dosing that we will use in our eventual human trials,” said Medolife CEO Dr. Arthur Mikaelian. “Escozine® has been shown to be effective in all of the pre-clinical proof-of-concept trials we have completed and successful completion of this study will propel the program forward into Phase II clinical trials. We decided to work with a renowned research partner as they are experts in this type of study and will be able to expedite the results so we can continue on with our next steps in the clinical program on Escozine®. We are extremely confident in Escozine® and its effectiveness and look forward to reviewing this data and using it to outline our next trial.”
Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the Dominican Republic (DR) where the Company has received product registration upon Escozine®. The registration enables Escozine® to be prescribed as a natural bioactive alternative medicine to be used in cancer treatments.
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the United States and globally. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds. Medolife has a “first-of-its-kind” scorpion reservation in the DR, where the Company is able to safely and humanely cultivate the scorpions needed to produce the peptides that are used in the manufacturing of Escozine®. Recently, the Company has been expanding the reservation and preparing to increase capacity in order to meet the demand driven by the registration in the DR and others in the future.
Up and down
Rinse and repeat
Then the company come through with the MEAT.
The BOOM time be coming.
Don't know when...
Date Open High Low Close* Adj Close** Volume
Oct 26, 2021 0.1398 0.1421 0.1382 0.1388 0.1388 2,793,649
Oct 25, 2021 0.1503 0.1526 0.1387 0.1404 0.1404 9,726,857
Oct 22, 2021 0.1409 0.1545 0.1305 0.1524 0.1524 21,993,644
Oct 21, 2021 0.1506 0.1549 0.1422 0.1479 0.1479 8,093,547
Oct 20, 2021 0.1545 0.1600 0.1510 0.1530 0.1530 3,806,565
Oct 19, 2021 0.1499 0.1590 0.1483 0.1530 0.1530 9,687,536
Oct 18, 2021 0.1605 0.1630 0.1495 0.1512 0.1512 17,503,770
Oct 15, 2021 0.1619 0.1619 0.1560 0.1617 0.1617 8,929,328
Oct 14, 2021 0.1680 0.1680 0.1600 0.1625 0.1625 11,736,894
Oct 13, 2021 0.1788 0.1788 0.1625 0.1645 0.1645 12,306,235
Oct 12, 2021 0.1844 0.1844 0.1712 0.1753 0.1753 9,300,164
Oct 11, 2021 0.1860 0.1863 0.1760 0.1800 0.1800 5,825,948
Oct 08, 2021 0.1951 0.2032 0.1777 0.1801 0.1801 33,202,815
Oct 07, 2021 0.1700 0.1985 0.1691 0.1932 0.1932 67,431,109
Oct 06, 2021 0.1700 0.1740 0.1570 0.1580 0.1580 7,896,328
Oct 05, 2021 0.1748 0.1748 0.1608 0.1720 0.1720 17,048,788
Oct 04, 2021 0.1775 0.1779 0.1600 0.1725 0.1725 11,563,134
Oct 01, 2021 0.1901 0.1934 0.1700 0.1770 0.1770 15,222,838
Sep 30, 2021 0.1700 0.1899 0.1570 0.1858 0.1858 33,163,500
Sep 29, 2021 0.2010 0.2075 0.1671 0.1710 0.1710 34,427,033
Sep 28, 2021 0.1621 0.1975 0.1605 0.1968 0.1968 36,780,042
Sep 27, 2021 0.1418 0.1589 0.1339 0.1540 0.1540 20,579,033
Sep 24, 2021 0.1380 0.1465 0.1325 0.1350 0.1350 10,482,274
Sep 23, 2021 0.1495 0.1500 0.1380 0.1381 0.1381 7,313,169
Sep 22, 2021 0.1320 0.1550 0.1320 0.1455 0.1455 11,579,424
Sep 21, 2021 0.1301 0.1385 0.1300 0.1330 0.1330 4,311,138
Sep 20, 2021 0.1399 0.1443 0.1293 0.1320 0.1320 7,660,883
Sep 17, 2021 0.1335 0.1449 0.1310 0.1406 0.1406 5,706,752
Sep 16, 2021 0.1395 0.1450 0.1325 0.1384 0.1384 11,386,752
Sep 15, 2021 0.1250 0.1510 0.1220 0.1495 0.1495 22,931,941
Sep 14, 2021 0.1200 0.1336 0.1182 0.1305 0.1305 12,455,500
Sep 13, 2021 0.1190 0.1249 0.1180 0.1196 0.1196 6,695,841
Sep 10, 2021 0.1250 0.1252 0.1177 0.1200 0.1200 6,386,535
Sep 09, 2021 0.1265 0.1265 0.1200 0.1203 0.1203 7,883,638
Sep 08, 2021 0.1275 0.1299 0.1220 0.1246 0.1246 5,218,727
Sep 07, 2021 0.1251 0.1330 0.1251 0.1275 0.1275 11,866,544
Sep 03, 2021 0.1260 0.1336 0.1220 0.1310 0.1310 16,334,244
Sep 02, 2021 0.1280 0.1337 0.1215 0.1251 0.1251 7,310,479
Sep 01, 2021 0.1430 0.1450 0.1275 0.1288 0.1288 13,986,517
Aug 31, 2021 0.1200 0.1430 0.1150 0.1406 0.1406 22,448,355
Aug 30, 2021 0.1200 0.1270 0.1151 0.1174 0.1174 12,557,854
Aug 27, 2021 0.1200 0.1255 0.1125 0.1250 0.1250 19,942,299
Aug 26, 2021 0.1230 0.1253 0.1168 0.1221 0.1221 21,115,551
Aug 25, 2021 0.1350 0.1412 0.1210 0.1252 0.1252 15,305,814
Aug 24, 2021 0.1502 0.1502 0.1322 0.1350 0.1350 12,847,440
Aug 23, 2021 0.1300 0.1450 0.1287 0.1410 0.1410 15,766,254
Aug 20, 2021 0.1388 0.1388 0.1160 0.1276 0.1276 29,043,631
Aug 19, 2021 0.1420 0.1442 0.1301 0.1332 0.1332 16,013,474
Aug 18, 2021 0.1535 0.1550 0.1350 0.1436 0.1436 23,908,597
Aug 17, 2021 0.1600 0.1600 0.1502 0.1534 0.1534 6,703,140
Aug 16, 2021 0.1650 0.1670 0.1510 0.1540 0.1540 9,220,685
Aug 13, 2021 0.1560 0.1665 0.1540 0.1550 0.1550 6,154,574
Aug 12, 2021 0.1600 0.1625 0.1558 0.1594 0.1594 6,192,685
Aug 11, 2021 0.1650 0.1690 0.1524 0.1600 0.1600 10,313,013
Aug 10, 2021 0.1699 0.1699 0.1596 0.1620 0.1620 8,581,801
Aug 09, 2021 0.1661 0.1810 0.1601 0.1629 0.1629 8,437,316
Aug 06, 2021 0.1691 0.1710 0.1640 0.1670 0.1670 7,934,204
Aug 05, 2021 0.1790 0.1790 0.1650 0.1691 0.1691 5,635,021
Aug 04, 2021 0.1815 0.1850 0.1620 0.1779 0.1779 17,554,274
Aug 03, 2021 0.1920 0.1950 0.1713 0.1780 0.1780 10,576,853
Aug 02, 2021 0.1608 0.1978 0.1558 0.1905 0.1905 19,559,103
Jul 30, 2021 0.1750 0.1798 0.1560 0.1603 0.1603 30,672,888
Jul 29, 2021 0.1895 0.1895 0.1760 0.1796 0.1796 12,035,768
Jul 28, 2021 0.1919 0.1960 0.1800 0.1850 0.1850 13,966,189
Jul 27, 2021 0.2076 0.2076 0.1902 0.1919 0.1919 12,034,095
Jul 26, 2021 0.1990 0.2000 0.1900 0.1995 0.1995 14,039,829
Jul 23, 2021 0.1850 0.1998 0.1850 0.1905 0.1905 13,095,401
Jul 22, 2021 0.2100 0.2101 0.1850 0.1873 0.1873 19,290,910
Jul 21, 2021 0.1980 0.2201 0.1930 0.2021 0.2021 31,491,022
Jul 20, 2021 0.2000 0.2080 0.1550 0.1889 0.1889 24,668,509
Jul 19, 2021 0.1980 0.2186 0.1916 0.2006 0.2006 30,807,733
Jul 16, 2021 0.1650 0.2150 0.1650 0.1927 0.1927 35,500,147
Jul 15, 2021 0.1650 0.1713 0.1550 0.1699 0.1699 11,718,204
Jul 14, 2021 0.1619 0.1735 0.1555 0.1630 0.1630 17,720,332
Jul 13, 2021 0.1750 0.1780 0.1605 0.1650 0.1650 15,577,294
Jul 12, 2021 0.1850 0.1850 0.1680 0.1760 0.1760 17,893,016
Jul 09, 2021 0.1930 0.1930 0.1800 0.1873 0.1873 11,012,182
Jul 08, 2021 0.1911 0.1990 0.1800 0.1904 0.1904 13,092,038
Jul 07, 2021 0.2050 0.2100 0.1890 0.1939 0.1939 13,620,725
Jul 06, 2021 0.2149 0.2150 0.1902 0.2036 0.2036 14,957,141
Jul 02, 2021 0.2000 0.2070 0.1780 0.2015 0.2015 18,112,584
Jul 01, 2021 0.1990 0.2050 0.1810 0.1880 0.1880 13,459,948
Jun 30, 2021 0.1975 0.1988 0.1752 0.1931 0.1931 19,905,652
Jun 29, 2021 0.2300 0.2307 0.1951 0.1986 0.1986 16,498,783
Jun 28, 2021 0.2091 0.2280 0.2090 0.2278 0.2278 25,518,558
Jun 25, 2021 0.1880 0.2049 0.1750 0.2030 0.2030 20,575,636
Jun 24, 2021 0.1630 0.2050 0.1630 0.1839 0.1839 28,845,644
Jun 23, 2021 0.1610 0.1790 0.1605 0.1765 0.1765 20,165,999
Jun 22, 2021 0.1755 0.1760 0.1510 0.1590 0.1590 28,897,653
Jun 21, 2021 0.1935 0.1935 0.1610 0.1675 0.1675 38,368,306
Jun 18, 2021 0.1980 0.2070 0.1855 0.1869 0.1869 18,509,342
Jun 17, 2021 0.2030 0.2289 0.1821 0.2010 0.2010 42,221,520
Jun 16, 2021 0.2511 0.2511 0.2015 0.2059 0.2059 45,000,647
Jun 15, 2021 0.2810 0.2820 0.2420 0.2456 0.2456 41,028,916
Jun 14, 2021 0.2833 0.3195 0.2770 0.2832 0.2832 39,701,003
Jun 11, 2021 0.2700 0.2899 0.2637 0.2770 0.2770 18,844,029
Jun 10, 2021 0.2675 0.2980 0.2518 0.2775 0.2775 46,941,734
Jun 09, 2021 0.2700 0.2760 0.2280 0.2618 0.2618 63,280,939
Jun 08, 2021 0.2990 0.3095 0.2510 0.2618 0.2618 87,357,704
Jun 07, 2021 0.2400 0.2979 0.2390 0.2975 0.2975 109,704,068
Jun 04, 2021 0.1860 0.2280 0.1780 0.2280 0.2280 64,776,429
Jun 03, 2021 0.1800 0.1898 0.1660 0.1800 0.1800 41,078,287
Jun 02, 2021 0.1490 0.1850 0.1488 0.1738 0.1738 83,239,507
Jun 01, 2021 0.1380 0.1545 0.1300 0.1496 0.1496 35,758,095
May 28, 2021 0.1200 0.1328 0.1179 0.1297 0.1297 34,939,977
May 27, 2021 0.1170 0.1190 0.1135 0.1180 0.1180 14,888,883
May 26, 2021 0.1220 0.1220 0.1140 0.1160 0.1160 13,982,630
May 25, 2021 0.1265 0.1300 0.1149 0.1196 0.1196 18,736,463
May 24, 2021 0.1135 0.1250 0.1111 0.1243 0.1243 20,303,134
May 21, 2021 0.1200 0.1200 0.1112 0.1135 0.1135 14,849,895
May 20, 2021 0.1150 0.1150 0.1056 0.1140 0.1140 13,632,356
May 19, 2021 0.1250 0.1290 0.1063 0.1140 0.1140 24,791,472
May 18, 2021 0.1275 0.1469 0.1251 0.1277 0.1277 23,436,597
May 17, 2021 0.1540 0.1600 0.1257 0.1340 0.1340 51,619,576
May 14, 2021 0.1060 0.1257 0.1060 0.1239 0.1239 30,738,831
May 13, 2021 0.1130 0.1290 0.1050 0.1070 0.1070 25,536,545
May 12, 2021 0.1130 0.1180 0.1025 0.1099 0.1099 21,681,894
May 11, 2021 0.1010 0.1228 0.0949 0.1130 0.1130 31,033,590
May 10, 2021 0.1161 0.1220 0.1001 0.1035 0.1035 31,202,942
May 07, 2021 0.1310 0.1325 0.1125 0.1195 0.1195 11,044,730
May 06, 2021 0.1190 0.1210 0.1095 0.1150 0.1150 25,712,041
May 05, 2021 0.1338 0.1375 0.1210 0.1255 0.1255 12,363,588
May 04, 2021 0.1475 0.1475 0.1253 0.1300 0.1300 17,414,763
May 03, 2021 0.1460 0.1560 0.1325 0.1415 0.1415 19,848,816
Apr 30, 2021 0.1250 0.1529 0.1200 0.1487 0.1487 25,488,919
Apr 29, 2021 0.1350 0.1400 0.1208 0.1220 0.1220 20,452,430
Apr 28, 2021 0.1411 0.1480 0.1350 0.1350 0.1350 15,993,676
Apr 27, 2021 0.1600 0.1600 0.1400 0.1460 0.1460 12,751,965
Apr 26, 2021 0.1599 0.1600 0.1480 0.1487 0.1487 19,449,782
Apr 23, 2021 0.1472 0.1570 0.1470 0.1480 0.1480 16,714,167
Apr 22, 2021 0.1585 0.1593 0.1361 0.1475 0.1475 25,942,757
Apr 21, 2021 0.1330 0.1624 0.1330 0.1472 0.1472 57,190,403
Apr 20, 2021 0.1305 0.1549 0.1200 0.1396 0.1396 69,743,230
Apr 19, 2021 0.1049 0.1359 0.0920 0.1350 0.1350 111,438,243
Apr 16, 2021 0.1250 0.1290 0.0866 0.1007 0.1007 152,149,655
Apr 15, 2021 0.1405 0.1435 0.1133 0.1248 0.1248 130,577,804
Apr 14, 2021 0.2249 0.2370 0.1121 0.1310 0.1310 147,024,738
Apr 13, 2021 0.2000 0.2365 0.1814 0.2240 0.2240 27,915,942
Apr 12, 2021 0.2450 0.2450 0.2000 0.2037 0.2037 22,904,553
Apr 09, 2021 0.1970 0.2323 0.1810 0.2323 0.2323 33,636,010
Apr 08, 2021 0.2139 0.2169 0.1890 0.1905 0.1905 17,568,405
Apr 07, 2021 0.1965 0.2277 0.1800 0.2046 0.2046 23,828,581
Apr 06, 2021 0.2740 0.2741 0.2011 0.2025 0.2025 51,038,780
Apr 05, 2021 0.1623 0.2470 0.1552 0.2468 0.2468 115,297,617
Apr 01, 2021 0.1910 0.1910 0.1510 0.1690 0.1690 88,297,655
Mar 31, 2021 0.2090 0.2099 0.1836 0.1902 0.1902 35,883,877
Mar 30, 2021 0.2400 0.2499 0.2020 0.2150 0.2150 16,265,583
Mar 29, 2021 0.2290 0.2424 0.2010 0.2359 0.2359 24,939,658
Mar 26, 2021 0.2202 0.2370 0.2100 0.2200 0.2200 21,632,284
Mar 25, 2021 0.2270 0.2499 0.2000 0.2220 0.2220 31,047,818
Mar 24, 2021 0.2848 0.2900 0.2350 0.2380 0.2380 27,685,501
Mar 23, 2021 0.3025 0.3075 0.2620 0.2795 0.2795 15,841,169
Mar 22, 2021 0.3050 0.3490 0.3000 0.3001 0.3001 16,585,908
Mar 19, 2021 0.3275 0.3275 0.2800 0.3008 0.3008 11,465,601
Mar 18, 2021 0.3231 0.3374 0.2801 0.3003 0.3003 17,667,356
Mar 17, 2021 0.2799 0.3411 0.2509 0.3300 0.3300 33,328,167
Mar 16, 2021 0.3200 0.3280 0.2750 0.2899 0.2899 39,414,824
Mar 15, 2021 0.3700 0.3780 0.3200 0.3299 0.3299 24,896,764
Mar 12, 2021 0.3500 0.3780 0.3450 0.3597 0.3597 12,814,866
Mar 11, 2021 0.3448 0.3850 0.3120 0.3510 0.3510 24,275,476
Mar 10, 2021 0.3700 0.3799 0.3300 0.3450 0.3450 21,888,042
Mar 09, 2021 0.4400 0.4560 0.3600 0.3849 0.3849 36,565,086
Mar 08, 2021 0.4100 0.4920 0.4030 0.4250 0.4250 46,996,767
Mar 05, 2021 0.2499 0.3880 0.2204 0.3880 0.3880 92,256,123
Mar 04, 2021 0.3799 0.3799 0.2230 0.2641 0.2641 108,269,174
Mar 03, 2021 0.4899 0.4899 0.3510 0.3930 0.3930 74,644,673
Mar 02, 2021 0.5400 0.5499 0.4700 0.4780 0.4780 25,158,102
Mar 01, 2021 0.6599 0.6599 0.5400 0.5480 0.5480 17,765,766
Feb 26, 2021 0.6001 0.6215 0.5285 0.6000 0.6000 20,456,533
Feb 25, 2021 0.6900 0.7150 0.5900 0.5960 0.5960 25,158,550
Feb 24, 2021 0.6889 0.7420 0.6270 0.6500 0.6500 48,050,666
Feb 23, 2021 0.6650 0.6900 0.4700 0.6110 0.6110 34,926,926
Feb 22, 2021 0.5499 0.6910 0.5400 0.6550 0.6550 48,952,251
Feb 19, 2021 0.4200 0.4770 0.4010 0.4739 0.4739 34,624,250
Feb 18, 2021 0.4990 0.5000 0.3688 0.3811 0.3811 64,273,330
Feb 17, 2021 0.6800 0.6900 0.5100 0.5657 0.5657 24,228,890
Feb 16, 2021 0.5800 0.7152 0.5599 0.6360 0.6360 32,533,151
Feb 12, 2021 0.6550 0.6650 0.4710 0.5491 0.5491 73,860,125
Feb 11, 2021 0.7500 0.7700 0.6000 0.6591 0.6591 38,765,419
Feb 10, 2021 0.9000 0.9200 0.5500 0.7174 0.7174 81,248,598
Feb 09, 2021 0.8110 0.9580 0.7472 0.8290 0.8290 62,155,509
Feb 08, 2021 0.5801 0.7400 0.5790 0.7390 0.7390 64,850,555
Feb 05, 2021 0.5370 0.5610 0.5000 0.5240 0.5240 69,394,498
Feb 04, 2021 0.3700 0.5670 0.3600 0.4775 0.4775 122,968,998
Feb 03, 2021 0.2920 0.3630 0.2854 0.3430 0.3430 84,232,468
Feb 02, 2021 0.2610 0.2929 0.2420 0.2850 0.2850 65,849,048
Feb 01, 2021 0.1992 0.2450 0.1900 0.2229 0.2229 41,865,413
Jan 29, 2021 0.1800 0.1900 0.1560 0.1729 0.1729 31,225,534
Jan 28, 2021 0.2101 0.2150 0.1630 0.1830 0.1830 32,109,569
Jan 27, 2021 0.2650 0.2650 0.1300 0.2120 0.2120 47,653,239
Jan 26, 2021 0.2140 0.2520 0.1989 0.2517 0.2517 38,660,307
Jan 25, 2021 0.1810 0.2040 0.1740 0.1980 0.1980 29,469,063
Jan 22, 2021 0.1680 0.1809 0.1650 0.1730 0.1730 23,055,231
Jan 21, 2021 0.1870 0.1870 0.1575 0.1780 0.1780 42,136,536
Jan 20, 2021 0.1238 0.1450 0.1145 0.1400 0.1400 33,079,691
Jan 19, 2021 0.1240 0.1250 0.1101 0.1185 0.1185 31,519,561
Jan 15, 2021 0.1321 0.1435 0.1101 0.1200 0.1200 28,792,735
Jan 14, 2021 0.1550 0.1550 0.1200 0.1330 0.1330 40,421,172
Jan 13, 2021 0.1250 0.1500 0.1210 0.1470 0.1470 57,858,990
Jan 12, 2021 0.1060 0.1162 0.0965 0.1161 0.1161 43,974,100
Jan 11, 2021 0.0837 0.1000 0.0748 0.0959 0.0959 46,618,121
Jan 08, 2021 0.0840 0.0896 0.0760 0.0795 0.0795 27,460,009
Jan 07, 2021 0.0720 0.0740 0.0648 0.0740 0.0740 20,687,387
Jan 06, 2021 0.0699 0.0699 0.0602 0.0670 0.0670 20,899,933
Jan 05, 2021 0.0700 0.0705 0.0501 0.0660 0.0660 30,144,396
Jan 04, 2021 0.0800 0.0810 0.0700 0.0700 0.0700 24,242,541
Dec 31, 2020 0.0799 0.0800 0.0655 0.0785 0.0785 21,461,970
Dec 30, 2020 0.0730 0.0850 0.0630 0.0768 0.0768 50,378,044
Dec 29, 2020 0.0750 0.0750 0.0650 0.0692 0.0692 20,044,658
Dec 28, 2020 0.0789 0.0800 0.0604 0.0699 0.0699 39,142,935
Dec 24, 2020 0.0581 0.0810 0.0581 0.0735 0.0735 43,923,355
Dec 23, 2020 0.0440 0.0680 0.0410 0.0600 0.0600 76,007,775
Dec 22, 2020 0.0410 0.0500 0.0375 0.0396 0.0396 67,370,557
Dec 21, 2020 0.0600 0.0646 0.0395 0.0519 0.0519 114,233,315
Dec 18, 2020 0.0641 0.0699 0.0600 0.0638 0.0638 27,764,181
Dec 17, 2020 0.0700 0.0739 0.0550 0.0668 0.0668 45,708,481
Dec 16, 2020 0.0850 0.0850 0.0671 0.0719 0.0719 38,276,529
Dec 15, 2020 0.0990 0.0990 0.0700 0.0780 0.0780 38,104,671
Dec 14, 2020 0.0943 0.1000 0.0917 0.0929 0.0929 30,121,269
Dec 11, 2020 0.0900 0.0995 0.0825 0.0912 0.0912 25,366,063
Dec 10, 2020 0.1099 0.1099 0.0625 0.0901 0.0901 68,820,498
Dec 09, 2020 0.0990 0.1240 0.0950 0.0990 0.0990 52,511,429
Dec 08, 2020 0.1000 0.1195 0.0895 0.1060 0.1060 71,798,130
Dec 07, 2020 0.0951 0.0978 0.0756 0.0957 0.0957 76,474,224
Dec 04, 2020 0.0770 0.0830 0.0700 0.0750 0.0750 51,406,162
Dec 03, 2020 0.0700 0.0879 0.0700 0.0750 0.0750 63,106,583
Dec 02, 2020 0.0701 0.0724 0.0510 0.0610 0.0610 116,770,319
Dec 01, 2020 0.1176 0.1176 0.0600 0.0750 0.0750 289,127,881
Nov 30, 2020 0.0795 0.1098 0.0600 0.1089 0.1089 180,582,764
Nov 27, 2020 0.0381 0.0503 0.0336 0.0502 0.0502 83,732,472
Nov 25, 2020 0.0420 0.0430 0.0275 0.0330 0.0330 247,057,917
Nov 24, 2020 0.0420 0.0435 0.0301 0.0393 0.0393 187,475,502
Nov 23, 2020 0.0201 0.0310 0.0201 0.0276 0.0276 258,472,181
Nov 20, 2020 0.0135 0.0200 0.0131 0.0194 0.0194 207,027,154
Nov 19, 2020 0.0129 0.0135 0.0121 0.0131 0.0131 52,898,508
Nov 18, 2020 0.0139 0.0154 0.0120 0.0122 0.0122 145,940,370
Nov 17, 2020 0.0112 0.0115 0.0097 0.0114 0.0114 65,500,690
Nov 16, 2020 0.0099 0.0100 0.0091 0.0096 0.0096 52,132,749
Nov 13, 2020 0.0084 0.0093 0.0082 0.0091 0.0091 69,918,285
Nov 12, 2020 0.0088 0.0092 0.0074 0.0080 0.0080 44,161,296
Nov 11, 2020 0.0096 0.0097 0.0085 0.0088 0.0088 25,090,942
Nov 10, 2020 0.0100 0.0100 0.0090 0.0094 0.0094 31,376,569
Nov 09, 2020 0.0104 0.0104 0.0085 0.0090 0.0090 40,820,082
Nov 06, 2020 0.0098 0.0104 0.0092 0.0094 0.0094 41,948,913
Nov 05, 2020 0.0095 0.0107 0.0091 0.0095 0.0095 70,935,119
Nov 04, 2020 0.0105 0.0114 0.0103 0.0107 0.0107 34,712,852
Nov 03, 2020 0.0113 0.0118 0.0103 0.0109 0.0109 44,134,884
Nov 02, 2020 0.0132 0.0133 0.0107 0.0108 0.0108 83,936,600
Oct 30, 2020 0.0105 0.0140 0.0104 0.0127 0.0127 265,230,348
Oct 29, 2020 0.0109 0.0110 0.0100 0.0105 0.0105 35,423,211
Oct 28, 2020 0.0109 0.0118 0.0095 0.0106 0.0106 90,735,433
Oct 27, 2020 0.0109 0.0109 0.0097 0.0103 0.0103 38,529,740
Oct 26, 2020 0.0120 0.0120 0.0100 0.0102 0.0102 56,992,881
SOW
The Scope of Work (SOW) is the area in an agreement where the work to be performed is described. The SOW should contain any milestones, reports, deliverables, and end products that are expected to be provided by the performing party. The SOW should also contain a time line for all deliverables.
9 Steps to Write a Scope of Work (SOW) for Any Project and Industry
What is a scope of work? And why do you need one?
At its core, a scope of work is a document that covers the working agreement between two parties. Usually that’s a client (aka you) and an agency, vendor, or contractor (aka the outside team you’re working with).
As a project manager, you’ll use a SOW to make sure expectations are clear and agreed-upon, and that both you and whomever you’re working with know exactly what they should be doing. To make that happen, an effective SOW should include things like:
Project objectives: Your problem statement. What is it the issue that you’re facing and what do you want to achieve with this project?
Schedule/Milestones: When is the project starting and when does it need to be finished by? What are the major milestones or phases of the project that you’ll be able to track and measure progress by?
Individual Tasks:What exactly needs to get done in order to go from where you are now to a finished project?
Deliverables: What do you need at the end of the project? Is it simply a .PSD file of the website mockup? Or usable code on a staging server that you can implement when you’re ready?
Payment Information: How much is the project going to cost and how are you going to pay the team you’re working with?
Expected Outcomes: The answer to your problem statement. Are you looking for an increase in traffic, conversions, or sales? What is the business objective that you want to hit with this project and how will you measure and report on it?
Terms, conditions, and requirements: Define the terms you’re using in the SOW and any conditions or requirements that aren’t already made clear.
While a project proposal helps get you buy-in for internal projects, a SOW is used when working with outside teams. Therefore, it needs to be especially clear, use language everyone understands, and set detailed tasks, deliverables, and other services.
A good SOW avoids some of the biggest project management traps, such as:
Confusion, miscommunication, and disputes over scope
Misinterpretations of expectations and needs
“Selective Amnesia” of what was said and the need for expensive rework
It’s a lot to ask. But if you pull it off, an SOW will ensure you, your stakeholders, and the outside teams you’re working with all have a clear idea of what a “successful” project looks like, and how you’re going to get there.
Will "Big Pharma" bite?
We are looking to partner with large pharmaceutical companies such as AstraZeneca and Pfizer, among others who produce chemotherapy drugs, in order to introduce them to polarization. Through our process we could increase the efficacy of chemo while reducing the dose required, alleviating the side effects of that drug for thousands if not millions of patients. The applications for this technology are truly endless and we’ve proven once again that it works with almost any API.”
Sid Said:
RGBP plans to rapidly advance novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is advancing small molecule therapies for treating cancer and autoimmune disorders by modulating the Checkpoint NR2F6. The company also developing products treating blood disorders using small molecules and gene silencing (DiffronC), treating cancer with cellular immunotherapy (dCellVax), modulating key molecular processes in cancer stem cell through its patented molecular targeting approaches (BORIS), and repairing damaged bone marrow in patients with aplastic anemia and chemotherapy/radiotherapy treated cancer patients (HemaXellerate). RGBP owns a valuable patent porfolio.
Key Word: small molecule
Why Small Molecules Are Still a Big Deal
Small molecules continue to play a role in innovative treatments for the four major indications that account for more than half of global pharma growth: oncology, diabetes, autoimmune, and respiratory diseases. For example, small molecule protein kinase inhibitors, of which the FDA has approved 48, are becoming more important in cancer therapy. Another area of growth entails the use of small and large molecules in combination; antibody drug conjugates (ADC), which couple potent small molecule payloads with the targeting capabilities of monoclonal antibodies, allowing for more precise treatment of cancer (and fewer side effects than standard chemotherapy).
Small companies are driving innovation. The vast majority of small molecule drugs in development are held by small or “emerging” companies with fewer than 100 employees. Our analysis suggests that these companies account for approximately 4,400 candidate compounds – or 70 percent of the small-molecule pipeline. These companies are increasingly bringing successful compounds to commercial production, and typically require access to enabling technologies, development, and manufacturing partners to do so.
In short, small molecules are still a big deal – and will be for the foreseeable future. CDMOs with specialized technologies and expertise will continue to help pharma companies advance their compounds. The ability to tailor services to specific customers and drug programs will play an increasingly important role in accelerating patient access to innovative drugs.
See the below link for entire article:
https://themedicinemaker.com/manufacture/why-small-molecules-are-still-a-big-deal
I don't think it will hit a dollar until after QNTA gets the approval for the IND application which should be sooner than later.
There will always be runs however for QNTA to have a sustained upward movement it will take consistent solid results. They have built a great brand and have a solid footing in moving through the FDA bureaucracy.
QNTA built it and I'm hopeful results will come.
There is no reason for the stock price to increase significantly at this point in time.
QNTA has a lot of things going on and until we see some results such as increased product sales or FDA approvals, the stock price will suffer.
ESCOZINE:
It is on a road trip with down the FDA freeway with detours along the way. However QNTA will reach their intended destination which is IND application approval.
Detour
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
Will there be more detours?
We will find out after QNTA submits the two addition toxicology studies.
We have people in our camp that should help to get us through the FDA approval process:
Welcome back Jim,
You were missed however Charles kept everything under control.
ENZC has a very promising future.
Many are concerned about the stock price however it will move when certain milestones are met and "Big Pharma" comes calling.
Samsung Biologics is just another step closer to the finish line.
Are we there yet.
Nope but we are getting closer and closer.
What is ENZC?
A little ole Biotech Committed to the Development of Proprietary Antiviral Peptides and Monoclonal Antibody for Treating Debilitating Infectious Diseases
What is ENZC Mission?
Our mission is clear – to create therapeutics that are effective and affordable for treating infectious diseases that plague the world. This goal includes the development of therapeutics and monoclonal antibodies targeting infectious diseases, including the CoronaVirus.
Our ultimate objective is to provide such therapeutics to improve health around the world.
What is their plan of action?
Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins for the treatment of debilitating infectious diseases. Enzolytics is committed to developing monoclonal antibody therapy and treating infectious diseases.
What assets does ENZC possess?
Intellectual property:
2 Patents with 14+ patents pending.
Proprietary Cell Line Producing Clone 3 anti-HIV monoclonal antibody
Proprietary Methodology for Producing Fully Human Monoclonal Antibodies
Human Capital:
Charles S. Cotropia – CEO and Chairman of the Board
Joseph P. Cotropia, MD – Chief Medical Officer and Director
Harry H. Zhabilov – CSO and Director
Gaurav Chandra, MD – Chief Operating Officer and Director
Ronald Moss, MD – Scientific Advisor
RABID Shareholders:)
Who are our Partnering Labs For Implementing Our Technologies?
Genscript Labs
The production of recombinant Monoclonal Antibodies from parent antibodies, necessary for patient treatment.
University of Strasbourg, France
Dr. Christiane Moog, MD, Research Director at INSERM U1109, HDR PBMC, In vitro neutralization testing of anti-HIV Monoclonal Antibodies.
California National Primate Research Center
Koen Van Rompay, D.V.M., Ph.D., Univ. of California Davis, California, Koen Van Rompay. Macaque trials of anti-HIV Monoclonal Antibodies.
Creative Biolabs
Custom recombinant Monoclonal Antibody production and large-scale antibody manufacturing.
Samsung Biologics
Enzolytics Inc. to leverage Samsung Biologics' development and manufacturing expertise to advance both Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapies to IND.
Samsung Biologics to offer a seamless, end-to-end CDMO service with support from its San Francisco R&D Center.
These Partnering labs are there to assist in moving our technology forward.
Just think about what Charles said about the licensees already lining up to get a piece of the ever growing pie.
Every time ENZC reaches a significant milestone they become more and more valuable.
We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon achievement of defined milestones.
That statement above will come to be after certain milestones are met and then BIG Pharma comes into play. It is my belief that ENZC may license/sell certain technologies (first with HIV and Covid 19 therapies) however if ENZC wants to ensure all their possible technologies make it to the marketplace they have to continue to develop the technologies for other diseases.
If ENZC was to sell the company outright then whoever buys it can do what they want with the technology.
Dr. Chandra said is best during a previous video:
This is very exciting
We have had discussions with large pharmaceutical companies.
There are tremendous interest in both the antibodies.
We have been offered interest in collaboration, partnership/acquisition of assets with a milestone based requirement.
We anticipate there will be a partnership with a larger entity before the twelve month period when the IND will be applied on both of the antibodies.
Final Thoughts:
We all are here to make money however as most know there are no guarantees.
This is a HIGH Risk HIGH REWARD investment. The risk goes down everyday as we move closer to certain milestones.
There are some predictive patterns to how biotech stocks start impressive runs and sometime Big Money loses patience and decides to make a move.
The current company only got started a year ago and look at all what it has accomplished. There has been bumps in the road and ENZC made adjustments to continue on to their objectives. One of the biggest setbacks was having to do the clinical trials again in Europe. Charles rolled up his sleeves and figured out what to do.
There will more bumps and more adjustments and I'm confident Charles will figure it out.
The Pot of GOLD is just months away however there will be nuggets leading us there along the way.
Yesterdays News is a necessary service for ENZC to develop and manufacture mAbs.
Enzolytics Inc. to leverage Samsung Biologics' development and manufacturing expertise to advance both Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapies to IND.
Samsung Biologics to offer a seamless, end-to-end CDMO service with support from its San Francisco R&D Center.
Much more to come in the weeks and months ahead.
ENZC is a Biotech company and nothing happens quickly with such companies.
ENZC has made tremendous progress since the merger.
The biggest setback was not being able to get the ITV-1 to the market without doing the trials again.
The trials will be redone and they probably won't be finished until next year.
Once ENZC reach certain milestones with the monoclonal antibodes they have been producing they have an expectation of Big Pharma coming on board.
Two of the key milestones is the animal testing and toxicology tests as these will help determine how safe it is to test on humans.
ENZC is just following the PROTOCOLS necessary to move their tech forward.
It is just going to take time.
Many things good and not so good will be happening along the way
Just think about what Charles said about the licensees already lining up to get a piece of the ever growing pie.
Every time ENZC reaches a significant milestone they become more and more valuable.
We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon achievement of defined milestones.
The mAbs PLAYBOOK:
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What has ENZC done?
CHECK THE PRESS RELEASES and follow RULES OF ENGAGEMENT BY THE FDA
Development of Monoclonal
Antibody Products Targeting SARSCoV-2, Including Addressing the
Impact of Emerging Variants,
During the COVID-19
Public Health Emergency
Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
INTRODUCTION
FDA plays a critical role in protecting the United States from threats such as emerging infectiousdiseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2, including addressing the impact of emerging variants, during the COVID-19 public health emergency.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
DISCUSSION
A. Guiding Principles
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following guiding principles:
• Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDAintends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the
data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.
• Given the dynamic public health situation created by changes in the prevalence of new variants over time, FDA’s streamlined approach will depend on its current assessment of benefit and risk for the intended use and population, the monoclonal antibody’s expected
coverage of important emerging variants, as well as FDA’s then-current understanding of SARS-CoV-2.
• FDA strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes5 to minimize the risk of losing activity against emergent variants. FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.
Development Program Considerations to Support Use Under an EUA
Chemistry, Manufacturing, and Controls
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following chemistry, manufacturing, and controls recommendations:
• When feasible and scientifically supported, sponsors should attempt to leverageexperience obtained from other monoclonal antibody products in development and already licensed monoclonal antibody therapies. Specific examples include the following:
? The use of existing manufacturing platforms to establish a manufacturing process for investigational product development
? The selection of manufacturing facilities6 that have experience in manufacturing biotechnology products and have a history of recent inspection(s) (including using information shared by trusted foreign regulatory partners through mutual recognition agreements7)
? The potential to utilize already obtained modular data for viral clearance validation,and a purification process validation (e.g., impurity clearance)
? The selection of analytical methods that have already been qualified or validated.This may include adapting potency assay9 formats (including binding assays and/or neutralizing assays) with revised reagents that evaluate new variant protein(s) or pseudotyped virus/virus-like particles in the assay(s)
? The exploration of opportunities for less-experienced manufacturers to partner with those with more experience to leverage all available development tools
? The use of data that may be available from public consortia or partnerships that may contribute to understanding product performance
? The leveraging of related product quality data (e.g., formulation development) tosupport in-use stability and compatibility
? The use of prior development experience to anticipate the best dosage form, route of administration, and formulation (composition) selection
• FDA strongly recommends that sponsors discuss with FDA in advance (well before they occur) time-critical elements of the development program. Specific examples include the following:
? A plan that describes key aspects of the manufacturing development, including plans for scale-up
? Comparability protocols that include a detailed description of tests and acceptance criteria to evaluate the impact of manufacturing process changes on product quality
? A strategy for establishing a shelf life for the intended monoclonal antibody product targeting SARS-CoV-2. This may include opportunities to leverage related product data to justify the proposed shelf life
• Certain approaches may be appropriate for limited early phase development to enable rapid introduction of the product into clinical trials. Specific examples include the following:
? Use of a stable cell pool in lieu of a clonally derived cell bank to generate early clinical batches
? Consideration of interim results from limited safety testing results (e.g., for cell banks, unprocessed bulk harvest) to begin first-in-human (FIH) clinical trial(s) with full study reports to be available at time negotiated with FDA and submitted to the investigational new drug application (IND)
? Flexibility in the amount of stability study results provided in the IND submission to support the initiation of FIH clinical trials
? Use of two robust orthogonal virus clearance steps when modular/generic virus clearance data are not available.
? Manufacture of limited early clinical batches for FIH clinical trial(s) by mixing and diluting with sterile filtration employing aseptic technique10 rather than traditional
drug product manufacturing.
• FDA may not require completed process validation (excluding sterilization process validation) to support an EUA. However, sufficient process characterization is expected and should be consistent with the overall benefit-risk assessment of the product. If only limited process validation data are provided, the sponsor can propose additional elements for the control strategy. These elements can include additional controls in the manufacturing processes, taking into consideration the criticality assessment for individual process parameters, the ranges proposed for a given parameter, or the inclusion of additional in-process measurements or release specifications.
Pharmacology Toxicology
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following
pharmacology toxicology recommendations:
• The Agency intends to be flexible regarding selected nonclinical safety data submission expectations (e.g., timing of data submission to the IND) for monoclonal antibody products targeting SARS-CoV-2 to support clinical trial initiation. The degree of flexibility warranted will be influenced by the benefit-risk assessment for the intended
population (e.g., hospitalized, nonhospitalized, healthy trial subjects) and the potential coverage of important emerging variants. Thus, FDA strongly recommends that sponsors discuss the nonclinical requirements to support product administration in a specific clinical trial with the Agency through the pre-IND consultation process.
• Nonclinical safety assessment for monoclonal antibody products targeting SARS-CoV-2 should follow approaches outlined in the International Council for Harmonisation (ICH) guidance for industry S6(R1) Preclinical Safety Evaluation of Biotechnology-Delivered
Pharmaceuticals (May 2012) and conduct the following:
? A tissue cross reactivity (TCR) study using a panel of human tissues.
When a monoclonal antibody binds to human tissues in the TCR study, FDA recommends evaluating monoclonal antibody binding to select tissues from nonclinical species to assist in species selection for repeat-dose toxicology testing. When binding of potential clinical concern is observed (e.g., cell membrane binding), FDA recommends discussing these data with the Agency because additional studies may be needed to help inform the potential clinical relevance of the findings.
? A short duration (i.e., 3 weeks of treatment) repeat-dose toxicology study in a single species, using the clinical formulation and route of administration(s) intended for clinical administration, that includes all standard toxicity endpoints including toxicokinetic analysis. FDA also recommends discussing specific study design considerations with the Agency.
• Toxicology studies with specific monoclonal antibody combinations are not needed for monoclonal antibody products targeting SARS-CoV-2 proteins, so monoclonal antibody products can be evaluated separately in toxicology studies. If a sponsor evaluates monoclonal antibody products in combination, FDA recommends using the same ratio intended for clinical administration.
• To support administration of monoclonal antibody products during pregnancy, FDA recommends conducting a TCR study using relevant human tissues or studies using alternative protein interaction technologies, with appropriate justification. If no specific concerns are identified in the repeat-dose toxicology and TCR studies, developmental and
reproductive toxicology studies are not needed.
Virology
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following
virology recommendations:
• A broad approach should initially be used to characterize the impact of amino acid changes, insertions, or deletions throughout the monoclonal antibody target protein to identify regions where changes specifically impact monoclonal antibody binding or activity, and subsequent analyses and surveillance can focus on these regions.
• Sponsors should monitor SARS-CoV-2 genomic databases continually for emerging SARS-CoV-2 variants and should evaluate phenotypically any specific variants that are prevalent or becoming prevalent that harbor substitutions in or near the target epitope.
The sponsor should conduct a more thorough analysis to include other substitutions at the same amino acid positions.
• Sponsors should characterize the epitopes to which monoclonal antibody products bind to enable identification of polymorphisms, which may affect binding, and to inform decisions regarding monoclonal antibody products planned for use in a combination therapy.
• Sponsors should characterize monoclonal antibody products with respect to epitope binding (affinity equilibrium dissociation constant (KD) and noncompetitive binding). The sponsor should characterize the mechanism of action for SARS-CoV-2 neutralization (e.g., blocking spike protein/receptor binding domain interaction with ACE2).
• The sponsor should determine the neutralizing activity (half maximal effective concentration (EC50) value) of investigational monoclonal antibody products, individually and if applicable in combination, against an array of circulating variants representing the diversity of the target protein and epitope to which the monoclonal antibody binds.
• The sponsor should evaluate the neutralizing activity of monoclonal antibodies,individually and if applicable in combination, against SARS-CoV-2 variants orpseudovirus harboring substitutions known to confer reduced susceptibility to other authorized or approved antibody products targeting SARS-CoV-2 infectivity.
• SARS-CoV-2 or pseudovirus should be serially passaged in cell culture in the presence of the monoclonal antibody product, individually and if applicable in combination, to select for resistant variants to understand the potential risk and nature of treatment-emergent
resistance. Sponsors should characterize genotypically and phenotypically the variants selected in this manner. Sponsors should determine the effect of resistance-associatedsubstitutions on approved and authorized monoclonal antibody products. These studies should be conducted under appropriate biocontainment.
• Clinical protocols should include detailed plans to (1) characterize the impact of SARSCoV-2 genetic variability on clinical and virologic outcomes (i.e., baseline resistance
analyses) and (2) identify SARS-CoV-2 genetic changes associated with treatment (i.e., treatment-emergent resistance analyses).
• Sponsors should also reference the guidance for industry COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (February 2021) and the guidancefor industry Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency (June 2006).
Clinical
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following clinical recommendations:
In general, sponsors should design monoclonal antibody product development programs evaluating the treatment or prevention of COVID-19 to assess the effect of investigational products on clinically meaningful aspects of the disease.
? An example of an acceptable endpoint to support an EUA for the treatment of outpatients with mild to moderate disease would be the proportion of patients with COVID-19 related hospitalizations or deaths from any cause through at least 28 days.
? Sponsors considering the use of a surrogate endpoint (e.g., viral pharmacodynamic endpoint) to support an EUA in situations where viral variants have affected the efficacy of currently authorized or approved treatment options should seek early input from the Agency on their proposals.
• Sponsors should scientifically justify the selection of doses and regimens for phase 3 trials and discuss with the Agency.
• Sponsors should enroll patients from populations disproportionately impacted by the COVID-19 pandemic (e.g., racial and ethnic minorities).
• The size and composition of the safety database needed to support an EUA will depend on factors such as the monoclonal antibody product’s proposed use (e.g., treatment versus prevention), the proposed patient population, and the extent and nature of the prior clinical experience with the product and with related products.
• Sponsors should also reference the guidance for industry COVID-19: Developing Drugs and Biological Products for Treatment or Prevention for additional recommendations on trial populations, trial design, efficacy endpoints, safety, and statistical considerations.
ALL RISE
Here comes ENZC!!!
ENZOLYTICS REPORTS PROGRESS ON ITS MULTIPLE THERAPEUTICS PLATFORMS AND INITIATIVES
News Release April 19, 2021
We continue to make great strides in applying our multiple platforms for the production of therapeutics for treating infectious diseases. Our future success will follow as we meet our goals to bring these therapeutics to market with new developments made possible by our extensive platform for producing new and effective therapies.
We acknowledge our partners Genscript (https://www.genscript.com), STC Biologics (https://stcbiologics.com), and California National Primate Research Center (University of Southern California) for their continued support in our research and development efforts. We are also grateful for the overwhelming support from world-renowned scientists and continue to expand our team of advisors to build a strong company based on research and development.
We are encouraged by the positive feedback received from pharmaceutical companies who have acknowledged an interest in partnering upon the achievement of defined milestones. The milestones we have set include the following:
Monoclonal Antibodies for Treatment of HIV Milestones
3rd Milestone: Animal Studies of anti-HIV Monoclonal Antibodies at California National Primate Research Center, University of Southern California
Time to completion: 6 months following in vitro testing in process.
5th Milestone: Production of additional Monoclonal Antibodies targeting identified sites (epitopes) on the HIV
Status: in process. Time to completion: 5-6 months
COVID-19
SARS-CoV-2 (Coronavirus) Monoclonal Antibodies Milestones
2nd Milestone: Production of Monoclonal Antibodies targeting identified sites (epitopes) on the SARS-CoV-2 virus
Status: In process. Time to completion: 3-4 months
3rd Milestone: Fast-Track Clinical Studies
Time to Completion: 6 months following the production of Monoclonal Antibodies
Production of Monoclonal Antibodies for HTLV-1/2
We are committed to developing universal, durable, and broadly neutralizing Monoclonal Antibodies for many infectious diseases. We have entered into an "intent to partner" agreement with a pharmaceutical company to create Monoclonal Antibodies against HTLV-1/2. We expect to complete the production by the end of 2021.
Monoclonal Antibodies for HTLV-1/2 Milestones
2nd Milestone: Creation of anti-HTLV1/2 Monoclonal Antibodies
Time to completion: 6-8 months following identification of target epitopes
CEO Charles Cotropia said, “The strength of our Company lies in our multiple technology platforms and the ability to produce fully human Monoclonal Antibodies against conserved and immutable targets on identified viruses. The viruses that may be addressed using our technology range from HIV to the Coronavirus to HTLV-1/2 to Ebola and many more. These numerous targeted viruses and bacteria are listed on our website [https://enzolytics.com/proprietary-therapeutics/]. We will continue to provide updates on our developments and progress toward completing the milestones we have set. We thank all our shareholders for their ongoing support of our Company and its technologies.”
https://www.otcmarkets.com/stock/ENZC/news/Enzolytics-Reports-Progress-On-Its-Multiple-Therapeutics-Platforms-and-Initiatives?id=298785
With most milestones completed or near completion it is time for ENZC to take the next step in the process and thus today we found out who will be providing their services to move ENZC forward.
· Enzolytics Inc. to leverage Samsung Biologics’ development and manufacturing expertise to advance both Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibody Therapies to IND.
· Samsung Biologics to offer a seamless, end-to-end CDMO service with support from its San Francisco R&D Center.
Development of therapeutic antibodies for the treatment of diseases
https://jbiomedsci.biomedcentral.com/articles/10.1186/s12929-019-0592-z
Production Processes for Monoclonal Antibodies
https://www.intechopen.com/books/fermentation-processes/production-processes-for-monoclonal-antibodies
Final Thought:
Regardless of the exact path that gives rise to the next generation of monoclonal antibody therapies, one thing is for certain: therapeutic antibodies can do things that few small molecules can, and as such will remain firmly a part of the drug development landscape for years to come.
https://www.nuventra.com/resources/blog/monoclonal-antibodies-past-present-and-future/
The Global Biologics CDMO Market was valued at USD 9.93 billion in 2020 and is expected to reach USD 18.63 billion by 2026, registering a CAGR of 10.87% during the forecast period (2021-2026)
The CMO/CDMO service sector is uniquely positioned to address some of the challenges that drug developers are facing amid the COVID-19 pandemic. This pandemic has impacted multiple aspects of the biopharma industry, from drug development, clinical trials, supplies, manufacturing, to supply chain logistics.
- The global pharmaceutical industry is growing at an exponential rate, which is driven by global economic growth, a growing and aging population, and new product launches. Even though small molecules continue to command the prominent share of the market, large molecules, such as biologics, biosimilars, and cell and gene therapies, are expected to witness the fastest growth over the forecast period.
- Cancer therapies are among the primary drivers for a large proportion of the growth in the biologics market. Even with the faster growth forecast, in terms of drug approvals, small molecules outweigh biologics. For instance, in 2020, the US Food and Drug Administration’s Center for Drug Evaluation and Research approved 53 new molecular entities (NMEs), of which 40, or 75%, were small molecules. This continues a recent trend of having approximately three-fourths of NME approvals be small molecules. In 2019, 79% of NME approvals were small molecules; in 2018, it was 71%, 74% in 2017, and 68% in 2016, when a recent low of 22 NMEs were approved.
- Top pharma companies’ propensity toward producing biologic drugs in-house is challenging the growth, as these drugs are high value, high margin products, owing to which large companies are focused on the security of supply, ensuring quality, IP protection of proprietary cell strains, and manufacturing process. For instance, unlike some of its peers in the drug industry, Pfizer has retained significant in-house manufacturing assets. It announced to make raw materials, the mRNA active, and finished doses for BNT162b2, the partnership’s vaccine, at its own plants in Andover, Massachusetts; Kalamazoo, Michigan, and St. Louis. It will also use its site in Belgium for the European market.
- However, pharma companies are more comfortable and willing to outsource the secondary manufacturing and packaging stages of their biologicsproducts even with the growing tendency to keep the biologic API production in-house. Another major factor influencing the growth in outsourcing of biologics to CDMO is the lack of available assets among CDMOs. This is expected to change over the next five years, due to the increasing investment from major CDMOs. For instance, Fujifilm Corp. is investing USD 928 million into Fujifilm Diosynth Biotechnologies, a CDMO for biologics and advanced therapies. This will double Denmark facility’s current drug substance manufacturing capacity, thus expanding its fill/finish and enhancing its assembly, labelling, packaging services.
- Further, Fujifilm Diosynth Biotechnologies also aims to build and open a mammalian cell culture facility in the United States in 2025. When the plant opens, it will boast eight 20,000 L stainless-steel bioreactor tanks for commercial drug substance manufacturing. It will also offer automated fill-finish and assembly, including packaging and labeling services.
- CDMOs are expected to form alliances and partnerships with pharma companies to expand and enhance their biologic services. For example, in August 2020, HJB, a biologics CDMO, entered a strategic partnership for CMC development and manufacturing with Ansun Biopharma on its therapeutic biologics pipeline.
- Furthermore, for technically difficult to manufacture products, such as biologics, where tech transfer can be a lengthy and expensive process, a single supplier relationship has the potential to reduce the risk of supply issues. The relationship should, in turn, create opportunities for the CDMO to sell more services to the same customer, as well as locking in products at an earlier stage in their life cycle.
Key Market Trends
Biologics to Drive the Market
- Monoclonal antibodies or synthetic versions of antibody have been representative of most successful therapeutic drug classes and attracts huge investment for the biologics industry. The use of monoclonal antibodies to treat diseases is called immunotherapy therapy because each type of monoclonal antibody will target a specifically targeted antigen in the body.
- Mammalian cells are traditionally used for monoclonal antibody production, however, plant-based expression systems have been gaining share due to significant advantages. The advancements in plant glycoengineering have allowed the production of monoclonal antibodies (mAbs) with more homogenous human-like glycans. iBio’s proprietary plant-based technology instead of CHO or other mammalian cell technologies led to the development of monoclonal antibody vectors free of any viral transforming functions or contamination from parental lines.
- Recombinant biologics are being developed by processes wherein a genetic code for a specific therapeutic protein is inserted into an expression vector’s DNA. The inserted DNA codes leads to recombinant protein being produced through replication in living host cells. Since the first recombinant therapeutic antibody (OKT3) in 1986, biologics products became a larger pharmaceutical industry percentage.
- Since biologics have been dominating the human drug development because of their long-lasting effects and ability to precisely address the molecular causes of disease, only one recombinant protein drug, an antibody, is available for veterinary use in the U.S. or EU.?
- Likewise, in February 2020, Invetx, invested USD 15 million Series A financing and undertook collaborations with WuXi Biologics and AbCellera. This is expected to drive clinical entry of a first therapeutic candidate and preclinical development of Invetx’s broader pipeline of protein-based therapeutics for Animal Biopharmaceutical Development.?
- According to the World Health Organization (WHO), as compared to the pharmaceutical market, the vaccine market is relatively small & concentrated on both supply and demand sides. Over time, the largest contract biologics manufacturers have been investing heavily in manufacturing capabilities to address unique product areas, including vaccines. And recently, the number of mergers and acquisitions and partnerships increased in light of new business models for vaccine research and development.
- In April 2020, Cytovance Biologics, a US-based CDMO and a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co., Ltd., entered into a collaboration agreement with Akshaya Bio, Inc., a Canadian development-stage biotechnology company. The latter would be provided with rapid access to clinical materials using Akshaya’s proprietary Chimigen Platform Technology for vaccine development for COVID-19 and HBV.
North America to Dominate the Market
- North America is one of the major markets for the biologics CDMO industry, owing to the presence of two major economies, such as the United States and Canada. The United States is home to one of the major pharmaceutical industries in the world and commands a significant share of the industry revenue; according to IQVIA, in 2019, the United States held about 48% of the global pharmaceutical market sales and seeing a steady growth in the last couple of years.?
- The United States is the world’s largest market for drugs and accounts for almost half of the R&D spending in pharmaceutical and biotechnology markets. Hence, biologic CDMOs play a critical role in this market and have invested in new facilities and technologies to cater to a wide range of outsourcers.?
- Moreover, the spending of the US pharmaceutical industry (PhRMA members) on R&D abroad totaled approximately USD 18.6 billion in 2019, according to PhRMA. With such a prominent presence in the market, the biologics CDMO vendors in the region are expected to scale up their presence and expand their capacities as well. For instance, AGC Biologics is looking to invest about USD 100 million into the AstraZeneca plant in Boulder; such developments are expected to increase over the coming years.
- Moreover, in August 2020, AGC Biologics, a global biopharmaceutical CDMO, partnered with Ono Pharmaceutical Co Ltd to manufacture its new biopharmaceutical at the clinical development stage. Such developments are expected to further increase over the coming years, further expanding the reach of CDMOs in biologics. Also, in December 2020, AGC Biologics announced its partnership with Laboratoire Pierre Fabre to manufacture ER-004, an intra-amniotic drug that would pioneer the treatment of a rare and debilitating genetic disorder.
- In addition to this, global biologics CDMO vendors are increasing their investments and are expanding their presence in the region. For example, in March 2020, Bora Pharmaceuticals expanded its footprint in North America. Over the coming years, CDMOs are expected to expand their presence in the region due to the growing health ailments and aging population.?
- Further, US-based KBI Biopharma announced plans to invest USD 150 million into a 140,000-square-foot commercial manufacturing facility in Research Triangle Park, North Carolina, to produce complex biologics including "therapeutic proteins" for a pharma partner. The newest facility would add 200 positions in operations and quality assurance, and is set to be operational in the first quarter of 2022. This site would complement KBI’s growing presence in clinical manufacturing after its parent company, Sunnyvale, California-based JSR Life Sciences, announced plans in October to boost its CDMO’s early-stage work in Geneva.
Competitive Landscape
The Biologics Contract Development and Manufacturing Organization (CDMO) Market is highly fragmented and consists of several major players. They have adopted different strategies such as expansions, agreements, new product launches, joint ventures, acquisitions, partnerships, and others to expand their footprints in this market. Major players of the market include Boehringer Ingelheim Group, Wuxi Biologics, Samsung Biologics, Lonza Group, and Fujifilm Diosynth Biotechnologies USA Inc among others.
- March 2021 - WuXi Biologics has entered into an equity agreement with Pfizer China to acquire its state-of-the-art biologics manufacturing facilities and its labor force in Hangzhou, China. This will boost the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands.
- January 2021 - Boehringer Ingelheim entered into a strategic collaboration and licensing agreement with Enara Bio to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen discovery platform. The collaboration combines Boehringer Ingelheim’s approach to tackling cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification.
https://www.globenewswire.com/news-release/2021/07/01/2256716/0/en/The-Global-Biologics-CDMO-Market-was-valued-at-USD-9-93-billion-in-2020-and-is-expected-to-reach-USD-18-63-billion-by-2026-registering-a-CAGR-of-10-87-during-the-forecast-period-20.html
Ten Top CDMOs
The landscape for contract development and manufacturing organizations (CDMOs) is a challenging one. Competition is fierce and regulatory scrutiny ensures that only the most efficient companies rise to the top of the industry. These firms use the latest technology developments to help their clients develop pharmaceutical products that meet the public’s need for effective treatments for a wide variety of conditions and ailments.
The firms listed below comprise our selection of the top CDMOs, taking into account factors such as revenue, profits, efficiency, scope of operations, and innovation. They are listed in alphabetical order.
BioVectra
Biovectra focuses on offering contract development and manufacturing capacity for intermediates and active pharmaceutical ingredients (APIs) at four cGMP facilities in North America. The company has been in business for more than 45 years, and specializes in the following areas:
· Microbial Fermentation
· Complex Chemistry
· High Potency APIs
· Biologics
· Process and Analytical Development
· Drug Development
Cambrex
Cambrex is focused on small molecule therapeutics including drug substance, drug product and drug analytical services over the full drug lifecycle. The company offers its customers end-to-end partnerships to research, develop and manufacture their small molecule products.
Cambrex went private in 2019 after being acquired for $2.4 billion by private equity firm Pemira Funds. Cambrex had previously purchased Halo Pharma, a contract provider of drug development and manufacturing services, for $425 million. This expanded the services offered by Cambrex, which previously focused mainly on offerings targeted at small-molecule active pharmaceutical development and manufacturing. In January of 2019, Cambrex spent $252 million to acquire Avista Pharma Solutions, which focuses on early-stage development and analytical testing services.
Catalent
Catalent provides integrated services, delivery technologies and manufacturing solutions designed to assist companies develop and launch pharmaceuticals, biologics and consumer health products. In 2019 Catalent acquired Paragon Bioservices of Baltimore, Maryland for $1.2 billion for the company’s expertise as a contract provider of viral vector development and manufacturing services for gene therapies.
CordenPharma
CordenPharma is the global pharmaceutical service & manufacturing platform of International Chemical Investors Group (ICIG). The company offers full-service contract development and manufacturing services to produce APIs, Drug Products and Packaging Services. The company has invested across Europe and the US in the form of Technology Platforms to enable its experts to work with projects at any stage of the development process.
CordenPharma uses its vertically-integrated supply chain model to provide development and manufacturing know-how that covers the complete cGMP supply chain, from regulated raw materials through intermediaries, APIs, commercial-scale Drug Product manufacturing, finished dosage formulation, packaging, clinical trial services and pharma logistics. The company endeavors to provide development and manufacturing at a reduced time and cost.
Fujifilm Diosynth Biotechnologies
Fujifilm Diosynth Biotechnologies, a subsidiary of Japan’s Fujifilm, is a biologics CDMO/CMO. It purchased Biogen’s biologics manufacturing site located in Hillerod, Denmark, outside Copenhagen, for $890 million. Fujifilm Diosynth also announced plans to invest around JPY 10 billion (about $90 million) in order to add to its production facilities in North Carolina. The company also said in May 2019 that it would expand its UK operations via the creation of a new BioCampus, estimated to cost $16.4 million.
GSK Contract Manufacturing
Glaxo SmithKline’s contract manufacturing unit provides fully integrated supply chain services for small molecule and biopharmaceutical products. It offers early-stage R&D and clinical supplies to the launch and growth of small, medium and large-volume medicines. The company possesses state-of-the-art facilities in a number of locations around the world. The company’s offerings include fill-finish capabilities.
The company’s contract manufacturing services cover:
· Active pharmaceutical ingredients
· Steriles and clean liquids
· Antibiotics
· Solid dose
· Platform technologies
· Inhalation
· BioPharm
· Foams, liquids and topicals
GSK Contract Manufacturing also offers discovery and development consulting aimed to help find innovative medicines to treat a broad range of diseases.
Lonza Bioscience
Lonza offers researchers in the life science sector the tools necessary to develop and test therapeutics all the way from basic research to product debut. The company’s products and services cover a wide range, including cell culture and discovery technologies for researchers and quality control tests and software to help in the biomanufacturing process. The company offers a variety of models to help safely test biopharmaceuticals. Lonza’s new eCHO Medium product is intuitive to use and economical while supporting a consistent yield of high-quality products for recombinant protein manufacture.
Pfizer CentreOne
Pfizer CentreOne is a global contract manufacturer focusing on API synthesis and sterile injectables fill-finish. It is a self-contained CMO embedded within the larger Pfizer organization. The company was formed from the merger in 2015 of Pfizer CentreSource, a leader in specialty APIs, and Hospira One 2 One, a major sterile-injectable CMO. The combination enabled the companies to offer a broader set of services to the biopharmaceutical industry.
In Pfizer CentreOne’s two main areas of specialty, API and drug product, the company focuses on the following:
Small-molecule steroid and hormone intermediates and APIs
Custom small-molecule API synthesis, and
Sterile injectables fill-finish
Samsung Biologics
Samsung Biologics offers end to end comprehensive one-stop service to provide cell-line development for commercial manufacturing of drug substances and products and biosafety testing services. The company’s manufacturing services include cGMP DS and DP manufacturing. Samsung Biologics also offers research services in its world class, state-of-the-art facilities which feature bioreactors that can manufacture at both large and small scales. The company has the largest single plant worldwide, with total capacity of 364,000L. The company has received the CMO Leadership Awards in all six categories for three years in a row through 2019.
Thermo Fisher Scientific
Thermo Fisher Scientific’s Patheon division offers CDMO services along with clinical trial solutions. The company utilizes over 55 locations worldwide to support end-to-end drug development in the following areas:
· API
· Biologics
· Viral Vector Services
· Early and Late Phase Development
· Clinical Trial Solutions
· Commercial Manufacturing
Thermo Fisher spent $1.7 billion in 2019 to purchase Brammer Bio, a CDMO specializing in viral vector manufacturing for gene and cell therapies. Also in 2019, Thermo Fisher purchased a site in Cork, Ireland for around $100.6 million for drug-substance manufacturing. The company said it plans to expand the site’s capacity to develop and commercially manufacture complex APIs.
https://www.healthtechzone.com/topics/healthcare/articles/2020/06/18/445728-ten-top-cdmos.htm