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Kramrer
Monday, November 01, 2021 7:30:40 PM
Re: penguin007 post# 12231
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Availa Bio filed for BK Chapter 11...https://unicourt.com/case/pc-bk5-availa-bio-inc-1637651
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U.S. Bankruptcy Courts
This case was last updated from U.S. Bankruptcy Courts on 12/11/2021 at 06:32:30 (UTC).
AVAILA BIO, INC.
Case Summary
On 10/12/2021 AVAILA BIO, INC was filed as a Bankruptcy - Chapter 11 lawsuit. This case was filed in U.S. Bankruptcy Courts, Nevada Bankruptcy. The Judge overseeing this case is NATALIE M. COX. The case status is Pending - Other Pending.
Case Details Parties Documents Dockets
Case Details
Case Number:
2:21-BK-14909
Filing Date:
10/12/2021
Case Status:
Pending - Other Pending
Case Type:
Bankruptcy - Chapter 11
Court:
U.S. Bankruptcy Courts
Courthouse:
Nevada Bankruptcy
Judge Details
Judge
NATALIE M. COX
EX-10.1 3 ex10_1.htm
REORGANIZATION AND STOCK PURCHASE AGREEMENT
BY AND BETWEEN CANNAGISTICS, INC., AVAILA BIO, INC. AND
CANNAWORX, INC.
T/B/K/A
THE INTEGRITY WELLNESS GROUP, INC.
July 1st, 2021
REORGANIZATION AND STOCK PURCHASE AGREEMENT
This REORGANIZATION AND STOCK PURCHASE AGREEMENT (the “Agreement”) is dated as of July 1st, 2021 (the “Effective Date”), by and among Cannagistics, Inc., a DE corporation (“CNGT”), Availa Bio, Inc., a NV corporation (“AVAILA”) and Cannaworx, Inc. t/b/k/a The Integrity Wellness Group, Inc. (“Cannaworx”), on the other hand. Each of CNGT, AVAILA, and the Cannaworx shall be referred to herein as a “Party” and collectively as the “Parties.”
W I T N E S S E T H
WHEREAS, AVAILA own 100% of the outstanding shares of Cannaworx’s outstanding common stock.
WHEREAS, AVAILA desires to sell and CNGT desires to purchase all of the AVAILA’s shares of Cannaworx in accordance with the terms set forth herein;
WHEREAS, the Parties desire and intend that the transactions contemplated by this Agreement will be a tax- free reorganization under Section 368(a)(1)(B) of the Internal Revenue Code of 1986, as amended.
NOW THEREFORE, in consideration of the premises and respective mutual agreements, covenants, representations and warranties herein contained, it is agreed between the Parties hereto as follows:
ARTICLE 1
SALE AND PURCHASE OF THE AVAILA SHARES
1.1 Sale of the Cannaworx Shares. At the Closing (as defined in Section 4.1), subject to the terms and conditions herein set forth, and on the basis of the representations, warranties and agreements herein contained, AVAILA shall sell to CNGT and CNGT shall purchase from AVAILA, all of the Cannaworx Shares.
1.2 Purchase Price. As consideration for the purchase of the Cannaworx Shares (the “Purchase Price”), CNGT shall issue AVAILA 4,400,000 shares of CNGT Convertible Preferred “F” stock. The Convertible Preferred “F” and the Convertible Non-Voting Preferred “E” stock certificate of designations are attached hereto as Exhibit “A”. Cannaworx shall become a subsidiary of CNGT.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
OF AVAILA AND CANNAWORX
2.1 Representations and Warranties of AVAILA and the Cannaworx. To induce CNGT to enter into this Agreement and to consummate the transactions contemplated hereby, AVAILA and Cannaworx, and each of them, represent and warrant as of the date hereof and as of the Closing, as follows:
2.1.1 Authority of AVAILA and the Cannaworx; Transfer of Cannaworx Shares. AVAILA and Cannaworx have the full right, power and authority to enter into this Agreement and to carry out and consummate the transactions contemplated herein. This Agreement, and all of the Exhibits attached hereto, constitutes the legal, valid and binding obligation of AVAILA and Cannaworx. AVAILA shall transfer title in and to the Cannaworx Shares to CNGT free and clear of all liens, security, pledges, encumbrances, charges, restrictions, demands, and claims of any kind or nature whatsoever, whether direct or indirect or contingent.
2.1.2 Existence of Cannaworx. Cannaworx is duly organized, validly existing, and in good standing under the laws of the state of Delaware. It has all requisite power, franchises, licenses, permits and authority to own its properties and assets and to carry on its business as it has been and is being conducted. It is in good standing in each state, nation or other jurisdiction wherein the character of the current business transacted by it makes such qualification necessary.
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2.1.3 Capitalization of Cannaworx. The authorized equity securities of Cannaworx consist of 10,000 common Shares of which 100 common shares are issued and outstanding. No other Shares of Cannaworx are issued and outstanding. All of the issued and outstanding Shares have been duly and validly issued in accordance and compliance with all applicable laws, rules and regulations and are fully paid and non- assessable. There are no options, warrants, rights, calls, commitments, plans, contracts or other agreements of any character granted or issued by Cannaworx which provide for the purchase, issuance or transfer of any Shares of Cannaworx nor are there any outstanding securities granted or issued by Cannaworx that are convertible into any Shares of Cannaworx, and none are authorized. Cannaworx is not obligated or committed to purchase, redeem or otherwise acquire any of its equity. All presently exercisable voting rights in Cannaworx are vested exclusively in its outstanding Shares, which voting rights are apportioned in accordance with each AVAILA respective ownership percentage of the Shares, and other than as may be contemplated by this Agreement, there are no voting trusts or other voting arrangements with respect to any of Cannaworx’s equity securities.
2.1.4 Execution of Agreement. The execution and delivery of this Agreement does not, and the consummation of the transactions contemplated hereby will not: (a) violate, conflict with, modify or cause any default under or acceleration of (or give any Party any right to declare any default or acceleration upon notice or passage of time or both), in whole or in part, any charter, article of incorporation, bylaw, mortgage, lien, deed of trust, indenture, lease, agreement, instrument, order, injunction, decree, judgment, law or any other restriction of any kind to which Cannaworx or AVAILA are a party or by which any of them or any of their properties are bound; (b) result in the creation of any security, lien, encumbrance, adverse claim, proscription or restriction on any property or asset (whether real, personal, mixed, tangible or intangible), right, contract, agreement or business of AVAILA or Cannaworx; (c) violate any law, rule or regulation of any federal or state regulatory agency; or (d) permit any federal or state regulatory agency to impose any restrictions or limitations of any nature on AVAILA or Cannaworx or any of their respective actions.
2.1.5 All taxes, assessments, fees, penalties, and other governmental charges with respect to Cannaworx have been paid
2.1.6 Books and Records. Cannaworx keeps its books, records and accounts (including, without limitation, in accordance with all applicable laws and regulations.
2.1.7 CNGT Shares to be Restricted Securities. AVAILA acknowledges that the CNGT Preferred Shares will be “restricted securities” (as such term is defined in Rule 144 promulgated under the Securities Act of 1933, as amended (“Rule 144”), will include the customary restrictive legend, and, except as otherwise set forth in this Agreement, that the shares cannot be sold for a period of at least one year from the date of issuance unless registered with the United States Securities and Exchange Commission (the “SEC”) and qualified by appropriate state securities regulators, or unless AVAILA obtains written consent from CNGT and otherwise complies with an exemption from such registration and qualification (including, without limitation, compliance with Rule 144).
2.1.8 Leases. Cannaworx either owns or has valid and existing leases with all facilities where its offices are located or where any of Cannaworxs equipment or other assets are located.
2.1.9 Employment and Consulting Agreements. AVAILA and/or Cannaworx shall execute Employment and/or Consulting Agreements with Emerging Capital Strategies, LTD., James Morrison and Rob Gietl. The Employment and/or Consulting Agreements are attached hereto as Exhibit “B”
2.1.10 Trademark and all rights thereto for Cannaworx, domain and all rights thereto.
2.1.11 Cannaworx shall have no liabilities, shall be current in all tax filings, no litigation or threatened litigation
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ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF CNGT
3.1 Representations and Warranties of CNGT. To induce AVAILA and Cannaworx to enter into this Agreement and to consummate the transactions contemplated hereby, CNGT represents and warrants, as of the date hereof and as of the Closing, as follows:
3.1.1 Authority of CNGT. CNGT has the full right, power and authority to enter into this Agreement and to carry out and consummate the transactions contemplated herein. This Agreement, and all of the Exhibits attached hereto, constitutes the legal, valid and binding obligation of CNGT.
3.1.2 Corporate Existence and Authority of CNGT. CNGT is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. It has all requisite corporate power, franchises, licenses, permits and authority to own its properties and assets and to carry on its business as it has been and is being conducted. It is in good standing in each state, nation or other jurisdiction in each state, nation or other jurisdiction wherein the character of the business transacted by it makes such qualification necessary.
3.1.3 Capitalization of CNGT. The authorized equity securities of CNGT consists of 500,000,000 shares of common stock, no value per share, of which 185,166,659 common shares shall be issued and outstanding as of the date hereof, and 20,000,000 shares of preferred stock, par value $0.001 per share, of which 10,000,000 are issued and outstanding. No other shares of capital stock of CNGT are issued and outstanding. All of the issued and outstanding shares have been duly and validly issued in accordance and compliance with all applicable laws, rules and regulations and are fully paid and nonassessable. All presently exercisable voting rights in CNGT are vested exclusively in its outstanding shares of common stock, each share of which is entitled to one vote on every matter to come before its Cannaworx. Other than as may be contemplated by this Agreement, there are no voting trusts or other voting arrangements with respect to any of CNGT’s equity securities.
3.1.4 Subsidiaries. CNGT has the following subsidiaries; Global3pl Logistics Technologies, Inc., Global Transitin Corp., Novi BioSciecne, Inc. and Global3pl, Inc.
3.1.5 Execution of Agreement. The execution and delivery of this Agreement does not, and the consummation of the transactions contemplated hereby will not: (a) violate, conflict with, modify or cause any default under or acceleration of (or give any Party any right to declare any default or acceleration upon notice or passage of time or both), in whole or in part, any charter, article of incorporation, bylaw, mortgage, lien, deed of trust, indenture, lease, agreement, instrument, order, injunction, decree, judgment, law or any other restriction of any kind to which CNGT is a party or by which it or any of its properties are bound; (b) result in the creation of any security , lien, encumbrance, adverse claim, proscription or restriction on any property or asset (whether real, personal, mixed, tangible or intangible), right, contract, agreement or business of CNGT; (c) violate any law, rule or regulation of any federal or state regulatory agency; or (d) permit any federal or state regulatory agency to impose any restrictions or limitations of any nature on CNGT or any of its actions.
3.1.6 Current Financial Information. CNGT shall be current in its financial reporting obligations to The Securities and Exchange Commission (“SEC”) and OTC Markets. Said reports are available at https://www.otcmarkets.com/stock/CNGT/disclosure. CNGT liabilities shall not exceed $50,000
3.1.7 Solid Bridge Investments, Inc. shall exchange 2,000,000 Series D Preferred shares for 145,000,000 Common shares. Solid Bridge Investments, Inc. Exchange Agreement is attached hereto as Exhibit “C”
3.1.8 Rob Gietl shall exchange 2,000,000 Series D Preferred shares for 145,000,000 Common shares. Rob Gietl Exchange Agreement is attached hereto as Exhibit “D”
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3.1.9 Emerging Growth Advisors, Inc. shall exchange 6,000,000 Series D Preferred shares for 900,000 Series E Convertible Preferred shares. Emerging Growth Advisors, Inc. Exchange Agreement is attached hereto as Exhibit “E”
3.1.10 Preferred Series A, B, C and D shall be cancelled. Written Consent is attached hereto as Exhibit “F”
3.1.11 Employment and Consulting Agreements. CNGT shall execute Employment and/or Consulting Agreements with Leonard Tucker, LLC., Cimarron Capital, Inc. and CKM Consulting, Inc. The Employment and/or Consulting Agreements are attached hereto as Exhibit “B”
ARTICLE 4
CLOSING AND DELIVERY OF DOCUMENTS
4.1 Closing. The Closing (the “Closing”) shall take place at the offices of CNGT, on or about July 1st, 2021, or at such other place, date and time as the Parties may agree in writing (the “Closing Date”).
4.2 Deliveries by CNGT. At the Closing, CNGT shall deliver the following:
4.2.1 CNGT shall deliver to AVAILA:
(a) written consent of the approval of this Agreement and the herein described transactions by CNGT’s Board of Directors. Written consent is attached hereto as Exhibit G.
(b) an officer’s certificate, executed by the President of CNGT. Officers certificate is attached hereto as Exhibit H.
(c) the CNGT Preferred Shares subject to no liens, security, pledges, encumbrances, charges, restrictions, demands or claims in any other party whatsoever shall be delivered as soon as practicable after closing;
4.2.2 AVAILA shall deliver to CNGT:
(a) written consent of the approval of this Agreement and the herein described transactions by AVAILA’s Board of Directors. Written consent is attached hereto as Exhibit I.
(b) an officer’s certificate, executed by the President of AVAILA. Officers certificate is attached hereto as Exhibit J.
(c) a confirmation of good standing, dated within ten (10) days prior to the Closing Date, evidencing the good standing status of Cannaworx. Cannaworx confirmation of good standing is attached hereto as Exhibit K.
(d) the Cannaworx Financial statement. Cannaworx shall have 0 liabilities.
(e) the Cannaworx Shares executed and ready for transfer subject to no liens, security, pledges, encumbrances, charges, restrictions, demands or claims in any other party whatsoever. The Cannaworx Shares are attached hereto as Exhibit M.
ARTICLE 5
CONDITIONS, TERMINATION, AMENDMENT AND WAIVER
5.1 Conditions Precedent. This Agreement, and the transactions contemplated hereby, shall be subject to the following conditions precedent:
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5.1.1 The obligation of CNGT to pay the Purchase Price and to satisfy its other obligations hereunder shall be subject to the fulfillment (or waiver by CNGT), at or prior to the Closing, of the following conditions, which AVAILA agrees to use its best efforts to cause to be fulfilled:
(a) Representations, Performance. If the Closing Date is not the date hereof, the representations and warranties contained in Section 2.1 hereof shall be true at and as of the date hereof and shall be repeated and shall be true at and as of the Closing Date with the same effect as though made at and as of the Closing Date, except as affected by the transactions contemplated hereby; AVAILA and Cannaworx shall have duly performed and complied with all agreements and conditions required by this Agreement to be performed or complied with by it prior to or on the Closing Date; and AVAILA shall have delivered to CNGT a certificate dated the Closing Date, and signed by its President to the effect set forth above in this section.
(b) Consents. Any required consent to the transactions contemplated by this Agreement shall have been obtained or waived.
(c) Litigation. No suit, action, arbitration or other proceeding or investigation shall be threatened or pending before any court or governmental agency in which it is sought to restrain or prohibit or to obtain material damages or other material relief in connection with this Agreement or the consummation of the transactions contemplated hereby or which is likely to affect materially the value of Cannaworx.
(d) Proceedings and Documentation. All proceedings of Cannaworx in connection with the transactions contemplated by this Agreement, and all documents and instruments incident to such proceedings, shall be satisfactory in form and substance to CNGT and CNGT’s counsel, and CNGT and CNGT’s counsel shall have received all such receipts, documents and instruments, or copies thereof, certified if requested, to which CNGT is entitled and as may be reasonably requested.
(e) Property Loss. No portion of Cannaworx’s assets shall have been destroyed or damaged or taken by condemnation under circumstances where the loss thereof will not be substantially reimbursed to CNGT through the proceeds of applicable insurance or condemnation award.
(f) Consents and Approvals. All material licenses, permits, consents, approvals, authorizations, qualifications and orders of governmental or regulatory bodies which are (1) necessary to enable CNGT to fully operate the business of Cannaworx as contemplated from and after the Closing shall have been obtained and be in full force and effect, or (2) necessary for the consummation of the transactions contemplated hereby, shall have been obtained. Any notices to or consents of any party to any agreement or commitment constituting part of the transactions contemplated hereby, or otherwise required to consummate any such transactions, shall have been delivered or obtained.
(g) As of the Closing Date, Cannaworx does not have a bank account, does not have any outstanding debits and/or credits, and all accounts payable if any will have been timely paid in accordance with their terms.
5.1.2 The obligation of AVAILA to deliver the Cannaworx Shares and to satisfy their other obligations hereunder shall be subject to the fulfillment (or waiver by AVAILA and Cannaworx), at or prior to the Closing, of the following conditions, which AVAILA agrees to use its best efforts to cause to be fulfilled:
(a) Representations, Performance. If the Closing Date is not the date hereof, the representations and warranties contained in Section 3.1 hereof shall be true at and as of the date hereof and shall be repeated and shall be true at and as of the Closing Date with the same effect as though made at and as of the Closing Date, except as affected by the transactions contemplated hereby; AVAILA shall have duly performed and complied with all agreements and conditions required by this Agreement to be performed or complied with by it prior to or on the Closing Date.
(b) Proceedings and Documentation. All corporate and other proceedings of CNGT in connection with the transactions contemplated by this Agreement, and all documents and instruments incident to such corporate proceedings, shall be satisfactory in form and substance to AVAILA and AVAILA’s counsel, and
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AVAILA and AVAILA’s counsel shall have received all such receipts, documents and instruments, or copies thereof, certified if requested, to which AVAILA is entitled and as may be reasonably requested.
5.2 Termination. Notwithstanding anything to the contrary contained in this Agreement, this Agreement may be terminated, and the transactions contemplated hereby may be abandoned prior to the Closing Date only by the mutual consent of all of the Parties.
5.3 Waiver and Amendment. Any term, provision, covenant, representation, warranty or condition of this Agreement may be waived, but only by a written instrument signed by the Party entitled to the benefits thereof. The failure or delay of any Party at any time or times to require performance of any provision hereof or to exercise its rights with respect to any provision hereof shall in no manner operate as a waiver of or affect such Party’s right at a later time to enforce the same. No waiver by any Party of any condition, or of the breach of any term, provision, covenant, representation or warranty contained in this Agreement, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such condition or breach or waiver of any other condition or of the breach of any other term, provision, covenant, representation or warranty. No modification or amendment of this Agreement shall be valid and binding unless it be in writing and signed by all Parties hereto.
ACCESSWIRE
Emergent executes Letter of Intent with Regen Biowellness, Inc.; Former L'Oréal President Jim Morrison to join Emergents Management Team
July 6, 2022·5 min read
In this article:
EMGE
+25.26%
HAUPPAUGE, NY / ACCESSWIRE / July 6, 2022 / Emergent Health Corp. ("Emergent") (OTC PINK:EMGE) announces it has executed a Letter of Intent to acquire Regen Biowellness, Inc., f/k/a Availa Bio, Inc. ("Regen"), a distributor of various products in the plant-based and regenerative medical fields.
Upon the completion of the transaction, Jim Morrison, President and CEO of Regen will join the management team of Emergent. Mr. Morrison is a legend in the personal care industry, most notably as President of L'Oréal. While at L'Oréal, Morrison oversaw growth that averaged more than 20% year-over-year. He engineered the acquisitions of Redken and Matrix and led the company during a period of unprecedented growth during his tenure. He is considered one of the top brand strategists in the personal care space. Morrison has had a long history of working with celebrities in the beauty space, such as Britney Spears, Kimora Lee Simmons, Flo Rida, Katharine McPhee, Christie Brinkley, Rob Lowe, Kylie Jenner and others. Morrison is currently CEO of Cannagistics, Inc. and Advisor to Kerluxe, Inc.
Emergent Health Corp., Wednesday, July 6, 2022, Press release picture
Emergent Health Corp., Wednesday, July 6, 2022, Press release picture
Business Week Magazine previously wrote: "Over the last two decades, Mr. Morrison has had a profound impact on the American Beauty Industry. In the industry's history no other executive has had the level of financial responsibility or breadth of organizational experience as Jim. His devotion to, and success within the American Beauty Industry is unmatched."
Excuse the language but wtf Is going on here!
Good morning loanranger. imo yesterday’s news was not as much about phase 2 or advancing to agreed on phase 3 parameters, rather about the results of the payer analysis opportunities.
Does anyone have access to FDA’s direct feedback of study results for phase 2?
July 22, 2022 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided an update on the Company’s Brilacidin program in Oral Mucositis (OM). Brilacidin, delivered as an oral rinse, was shown in Phase 2 clinical testing (NCT02324335) to reduce incidence, delay onset and decrease duration of severe OM (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The Company and FDA have completed an End-of-Phase 2 meeting and agreed to an acceptable Phase 3 program.
Commercial Opportunity:
Annually, in the U.S., Brilacidin has the potential to address 52,000 OM patients in HNC, with potential future extension to 20,000 OM patients in Hematopoietic Stem Cell Transplantation (HSCT), and 160,000 OM patients in all chemotherapy categories. Based on physician estimates of Brilacidin adoption and other pricing-based assumptions, forecasts of U.S. annual sales are $188 million for OM in HNC patients in 2030, with a potential additional upside of $106 million for OM in HSCT and $598 million for OM in all chemotherapy categories. "This analysis reinforces Brilacidin's potential to become a breakthrough OM treatment and commercialization success
Coverage Perspectives:
Developing Brilacidin as a New Drug Application (NDA), via the 505(b)(1) pathway, significantly improves Brilacidin’s commercialization prospects in the OM therapeutic area. OM products, such as MuGard, GelClair, Episil, and Caphosol, which were developed as devices and not drugs, have struggled to show clinical benefit, as they are primarily palliative in nature, and from a government payer perspective are not covered under Medicare Part D. Reimbursement Landscape: At least 2 approved drugs in all therapeutic drug classes must be made available under Medicare Part D, per USP Medicare Model Guidelines. The guidelines establish the framework (the rules) that drive payer formularies.
*Given there are no approved drugs for OM in HNC, should Brilacidin be approved, it is highly likely it would be included in payer formularies as a pharmacy benefit.
Key statements in this paragraph….
Competitive Positioning: Brilacidin’s oral sachet formulation was perceived as convenient and highly preferred by key opinion leaders (KOLs) in comparison to intravenous (IV) options, and KOLs are willing to prescribe Brilacidin for all HNC patients because the compound’s preventative properties and ease of use as an oral rinse. Brilacidin has the potential to be a first-line product for prevention and treatment of SOM due to efficacy perceived as being highly clinically meaningful.
Mike check out va*pr…thoughts?
Great post….thank you for posting.
Yes… Let’s hope so. I’m waiting in the wings with you Penny
So well put lemoncat
Many prayers for you pegs….
Fingers crossed that the facility is ready for reinspectionas you say “July/august”. IMHO they should have been adequately prepared to begin with.
Thank you Gio!
I conveyed that to her…. Problem is her kidneys are now shot and the doctor has told her to lay off the D3 vitamins. She swears only way she made it through the last Cove it is because this doctor did give her ivermectin. Oh and on top of things she’s asthmatic.
Hi Giovanni…do you have any insight as what a person who had Covid twice along with double lung pneumonia twice and and now has been on antibiotics for so long that her gut is destroyed and she’s still not feeling better what direction should she go?
Once resubmitted any idea timeline until we hear back from fda? Do we fast track and move to front of the line for reconsideration?
TIA
AITX Forecasts Profitability
6:01 AM ET 7/11/22 | GlobeNewswire
AITX Forecasts Profitability
Detroit, Michigan, July 11, 2022 (GLOBE NEWSWIRE) -- Artificial Intelligence Technology Solutions, Inc., (OTCPK:AITX), today announced that its sees a clear pathway to profitability within 24 months, principally through the growth of its primary subsidiary, Robotic Assistance Devices, Inc (RAD).
RAD confirmed that there are presently 114 RAD devices on backorder and allocation for deployment. The company sees a high probability path that it will close the current fiscal quarter on August 31, 2022, with over 300 customer new committed units ordered during in the period.
"We talk about sales momentum and it's great to see it begin, but I feel we're barely scratching the surface given the extraordinary labor and wage challenges our dealers and clients are suffering from," said Mark Folmer, President of RAD. "Just a year ago, we celebrated every single unit sale, today the mean sales order volume is greater than 20 units per order."
Folmer estimated that current projections create expectations of between 700 and 1200 units committed and on order by the end of this fiscal year which ends February 28, 2023.
"The majority of our sales to date and through this quarter are with organizations that are first-movers and leaders in their respective vertical markets," Folmer added. "Then there's the 'fear of missing' out that follows from the companies that are chasing the leader who's choosing RAD. We're seeing it in just about every sector."
"As we continue this strong upward momentum and level our SG&A expenditures, we have a likelihood of profitability during our next fiscal year," said Steve Reinharz, CEO of AITX and RAD. "Once we get in the range of one-thousand to fourteen-hundred deployed units, generating a stream of revenue, we expect to see an operational cash flow break-even, depending on the product mix."
The company added that moving forward SG&A expenses are expected to grow only in support of future demand and revenue growth. "We've built a team with remarkable productivity. This, in addition to the systems and processes we've implemented, create a business foundation that positions AITX squarely on this path to profitability. All elements for sustainability are in place, all that's left is our continued excellence, execution, and performance," Reinharz concluded.
AITX has filed for uplisting to the OTCQB. Future announcements will be made regarding the status of the OTCQB application.
Spot on Mike
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166724313
Yes cannagistics inc is regen bio wellness.
Yep…
Revive Therapeutics (RVV.C) clears FDA hurdles
Lukas Kane
June 28, 2022
Biotech companies receiving “thumbs-up” from the FDA, tend to be favored by investors.
Revive Therapeutics (RVV.C) is one such company.
Revive is researching and developing therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as:
Orphan Drug
Fast Track
Breakthrough Therapy
Rare Pediatric Disease designations
Being accepted into any of the above categories removes some hurdles and expenses, while creating a smoother pathway to commercialisation.
RVV is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
With its acquisition of Psilocin Pharma Corp, Revive is also advancing the development of Psilocybin-based therapeutics in various diseases and disorders.
Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.
On June 24, 2022 RVV provided an update on the company’s FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Following RVV receiving positive comments from the FDA in regards to the Company’s request to determine and agree on the Study’s potential new primary efficacy endpoints and the Company’s submission of a Data Access Plan to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data.
The Company will now proceed to unblind the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints.
The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.
The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.
The FDA is giving RVV increased flexibility to create meaningful comparative data.
On May 31, 2022, Revive announced that in light of the growing cases of acute hepatitis in children reported by the World Health Organization (WHO), it will advance its drug pipeline for inflammatory liver disorders including Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis.
As of May 26, 2022, six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022.
At least 38 children have required a liver transplant, nine have died, and 99 cases pending classification, according to a statement from WHO.
A month ago, Trade to Black did an excellent deep-dive interview with the knowledgeable articulate Biomedical Engineer and RVV investor, Arri Morris.
“Most research out there is focused on attacking the virus, and really antagonizing COVID itself,” explained Morris, “This drug Bucillamine is aimed at the person and improving clinical outcomes for patients.”
“The problem with attacking the virus itself, is that this virus is a shapeshifter. We get a new variant pretty regularly now. If you have something aimed at the virus, it’s likely to stop working in the future. If you have something aimed at helping the patient, it’s much more durable, and I think will stand the test of time”.
At the height of the pandemic, RVV was trading at .68.
By March 28, 2022 the stock price had fallen to .18.
Since then, amidst a slew of good news from the FDA, the stock has more than doubled to .43 – with a current market cap of $139 million.
Try Googling “Bucillamine” and you’ll discover that it is a sort of medical Swiss-Army-Knife with an array of utilities including “regulating B-cell function” “thiol antioxidant” and “cisplatin-induced otoxicity”.
Revive Therapeutics is exploring the use of the drug Bucillamine as a potential novel treatment for infectious diseases including influenza and the coronavirus disease (Covid-19).
Investors should keep their eyes on the Phase 3 trial. The current noises from the FDA are positive.
At this point, commercialization of RVV’s products is more than a pipe dream.
More on RVV.C
Joseph Morton
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Awww ok. Thank you For the insight
$5mm block today…wow
We have action!Cannagistics(OTCPK:CNGT)
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Cannagistics (OTC:CNGT), Quotes and News Summary
Hepion Pharmaceuticals Receives FDA Orphan Drug Status Designation for Rencofilstat for the Treatment of Hepatocellular Carcinoma
Source: GlobeNewswire Inc.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical mid-stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to rencofilstat, a liver-targeting, orally administered, novel cyclophilin inhibitor, for the treatment of HCC.
HCC is the most common form of liver cancer, accounting for 85-90% of all cases. NASH, viral hepatitis infection, and alcohol consumption all are major causes of HCC. Worldwide, it is estimated that over 800,000 people died from liver cancer in 2020, second only to lung cancer among all cancer-related deaths.1 The high mortality is largely due to the fact that only around half of all people who develop HCC (in developed countries) receive the diagnosis early enough to have an opportunity for therapeutic intervention. Additionally, recurrence rates are high, and effective treatment options remain limited.
“Orphan Drug Designation for rencofilstat in HCC represents a significant milestone for Hepion and its recognition by the FDA of the potential for rencofilstat to address a significant unmet medical need for patients suffering from this aggressive cancer,” said Robert Foster, PharmD, PhD, Hepion’s CEO. “In addition to two Phase 2 studies in patients with NASH, we remain on track to initiate patient enrollment in a Phase 2a study of rencofilstat in HCC in the third quarter of 2022.”
The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended for the prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people in the United States. Sponsors of medicines that are granted Orphan Drug Designation are entitled to certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.
Trading blocks do not look like general retail trades.
JMHO….
3
Soft trade volume today but still holding solid.
100% agree with you Jo
Relief Therapeutics Files Amendment No. 3 to its Registration Statement on Form 20-F with the U.S. Securities and Exchange Commission
Fri, June 17, 2022, 12:25 AM·3 min read
In this article:
RLFTF
-3.94%
RLFTY
0.00%
GENEVA, SWITZERLAND / ACCESSWIRE / June 17, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) ("Relief"), announced today that it has filed Amendment No. 3 to its Registration Statement on Form 20-F ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC"). The Registration Statement is intended to register Relief as a reporting company under the Securities Exchange Act of 1934. The Registration Statement has been filed as part of an ongoing program to convert Relief's Level 1 American Depositary Receipt ("ADR") program in the United States to a Level 2 ADR program, and is part of Relief's ongoing efforts to list its ADRs on the NASDAQ Stock Market. The NASDAQ listing will only occur after the Registration Statement has become effective, which is subject to a continuing review of the Registration Statement by the SEC, and the filing by Relief of a listing application with the NASDAQ (which has not yet occurred). There can be no assurance that the Registration Statement will become effective or that Relief will be successful in its efforts to list its ADRs to the NASDAQ Stock Market.
Relief Therapeutics Holdings AG, Friday, May 6, 2022, Press release picture
Relief Therapeutics Holdings AG, Friday, May 6, 2022, Press release picture
The filing of the Registration Statement is not part of an offering of securities. Therefore, Relief will receive no proceeds from its current ADR program.
?? % agree with you Jo
WTF … patience is wearing thin.
June 15, 2022
H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating on PharmaTher Holdings Ltd (PHRRF – Research Report) yesterday and set a price target of C$5.00. The company’s shares closed last Tuesday at $0.13, close to its 52-week low of $0.08.
Seems like quiet accumulation. Someone or some entity doesn’t want to draw attention to themself “just yet”
JMHO….3bb
KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale
Study results are adequate to give an effect size in powering a placebo-controlled clinical study
PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depression
TORONTO, June 07, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive results from an investigator-led observational study (the “Study”) evaluating the impact of KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. KETABET™ aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.
Ditto!