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Any unofficial updates regarding CRXM?
Is this related to PACV?
I understand CYDY has used AI to come up with additional formulas and indications for leronlimab. Unfortunately I don't think Chris has the money to do anything like that although it could present some options.
3 months or more since I have been aware of the $20m plan. Be nice to hear an update.
AAV research 2022 press release, plus 2024 pre-clinical poster abstract
Here's the July 2022 press release announcing the NIH grant for the AAV research with Leronlimab.
https://www.cytodyn.com/newsroom/press-releas...ional-cure
"The grant will fund the development and preclinical research of a single-injection gene therapy that codes for the leronlimab protein sequence and which will be delivered via an adeno-associated virus (AAV) vector. The study will examine if this gene-therapy approach could provide the potential for “functional cure,” i.e., sustained viral suppression to people with HIV without requiring them to take medications for the rest of their lives."
Here's the July 2024 poster abstract at
https://programme.aids2024.org/Abstract/Abstr...actid=3857
"In two of the RMs, SHIV viremia declined and reached undetectable levels between 10-40 weeks post-AAV, and those levels have remained undetectable through 70 weeks post-AAV. The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1 year post-reexpression. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma viremia."
abstract released today
https://programme.aids2024.org/Abstract/Abstr...actid=3857
excerpts
Title
Delivery and long-term expression of CCR5-blocking monoclonal antibody Leronlimab with AAV for ART-free remission from SHIV viremia
BACKGROUND: CCR5 blockade represents a scalable non-transplantation approach for long-term ART-free HIV remission. Here, we tested if AAV vectors could induce long-term expression of CCR5-blocking monoclonal antibody Leronlimab in a SHIV-infected rhesus macaques (RMs).
METHODS: Four SHIV-infected RMs received AAV9 encoding macaque Fc Leronlimab with stabilizing, silencing, and half-life extending mutations (AAV9-MacLSLeron). Animals were monitored longitudinally for CCR5 receptor occupancy (RO), plasma Leronlimab concentrations, antidrug antibodies (ADAs), and SHIV plasma viral loads.
RESULTS: All four AAV9-MacLSLeron-treated RMs reached 100% CCR5 RO on blood CD4+ T cells within 1 week and plasma Leronlimab was detected (>1ug/ml) within 2 weeks of AAV administration. In two of the RMs, SHIV viremia declined and reached undetectable levels between 10-40 weeks post-AAV, and those levels have remained undetectable through 70 weeks post-AAV. The remaining two RMs developed ADAs within 5-15 weeks post-AAV resulting in complete clearance of Leronlimab from plasma as well as a rapid decline in CCR5 RO. Spontaneous reemergence of CCR5 RO by Leronlimab was observed approximately 1 year post-AAV. One of the two animals has had full and sustained CCR5 RO, detectable plasma Leronlimab, and undetectable SHIV RNA in plasma for over 1 year post-reexpression. The second re-expressing animal has achieved and maintained 100% CCR5 RO for about 10 weeks, has detectable plasma Leronlimab, and has declined plasma viremia.
CONCLUSIONS: While further investigation is needed to develop AAV vectors and/or regimens that reduce the incidence of ADAs, the transgene reexpression phenomenon we have observed highlights the need to further investigate the interplay between AAV establishment and the development of ADAs. Overall, these data demonstrate the potential of AAV vectors for sustained antibody-based CCR5 blockade as a gene therapy approach for long-term ART-free HIV remission.
Your idea of good news is what we should have as just normal operations.
Closing orders only according to Schwab this morning
If the company stays private, there needs to be a way to connect shareholders to buy and sell shares. I owned a shares of stock in a local community bank that was growing its business. The President of the bank had a list of buyers and sellers he would connect. Eventually a link on the banks website allowed shareholders to deal directly with each other.
It would be nice to hear progress details. I'm keeping my fingers crossed CR will be able to put the financing together to move forward with the study. It will be interesting to hear what is in store for CRXM as a company and common shareholders.
Where else would you find the most respected woman in meat?
You probably have to do the trade through a broker phone call.
Thanks for the update. We’ll see what happens but I’m not holding my breath.
Putting money in most of these OTC stocks is more like going to Vegas than real investing. PACV could have been different considering they have or perhaps had real products with revenue and employees. I'm not sure it is dead yet as a company but it might be over for us shareholders. It is extremely rare for companies to make it back when they get demoted to a lower exchange.
Nothing but silence for shareholders.
Shame. Thanks.
Hey, BTW, I just saw your private reply post to me from back in May.
I do have the document but I won't share more since I did the super secret handshake. LOL. Perhaps CR will make it available soon.
Yeah that is it thanks. Any idea what happened to him?
Anyone remember the alias of the guy who posted a few years back a fair amount. Older. Trader back in the day. Always dropping stories about deals he had been in on. Has not posted in a long time.
Experienced Leadership & Small Management Team: Gene Bio’s management team is led by Christopher
J. Reinhard, the founder of Gene Bio who has been a driving force responsible for advancing the Generx product
candidate from a pre-clinical lab study at the University of California-San Diego into this current FDA-cleared
Generx Phase 3 clinical study program. Mr. Reinhard was also instrumental in raising over $200 million to lead
and support the Generx development effort. He has also been responsible for three other successful FDA product
registrations.
Nostrum Pharmaceuticals operates multiple manufacturing facilities, supported by sales, marketing and
distribution activities. Nostrum sells generic drug products to hospitals and retail drug stores, by prescription
only, throughout the United States. Nostrum has facilitated the company’s recent financial restructuring and was
responsible for the development of a new Phase 3 clinical plan for FDA registration, and the commercial biologics
manufacturing plan for the Generx product candidate at FujiFilm Bio in Texas.
Nostrum currently owns approximately 75% of Gene Biotherapeutics and approximately 25% is owned by Gene
Bio’s formerly public company shareholders. Following completion of his funding, these shareholders will be
issued contingent value rights (“CVR”) for their proportional share from the net cash distribution entitlements
from the sale of Generx. Gene Bio investors currently own an 85% interest in Generx, and Huapont Life Sciences,
a Chinese-based, publicly traded, pharmaceutical company, owns a 15% equity interest in Generx, and Huapont
Confidential
4
has an exclusive right to manufacture (under certain conditions) market and sell Generx in mainland China
following FDA approval of Generx in the United States.
Nostrum has had some financial setbacks and challenges with its core business, which is why we are now seeking this financial strategic joint venture offering to secure external financial resources to accelerate the clinical developement and commercialization of our Generx product candidate at this time.
Business Strategy: Gene Bio is a small biotechnology research and development boutique, located in San
Diego, that operates with a near-virtual, cost-conserved operating structure. We have a small, highly
experienced team that is currently singularity focused on the successful clinical development and strategic sale
of Generx. This team has worked together on the scientific, medical and clinical development of Generx over the
past 15 years. Set forth below are the key contractors that will be utilized to complete the FDA-cleared Phase 3
Generx study:
(1) FujiFilm Diosynth Biotechnologies: FujiFilm Bio is a world scale operation located in College Park,
Texas. They have expertise in process development and cGMP manufacture of cell and gene therapy
products oncolytic viruses and virial vaccines. We have entered into a manufacturing agreement with
FujiFilm Bio to manufacture Generx supplies for the planned Phase 3 clinical study, and they also have
the current capability to commercially manufacture final Generx product following FDA approval. We
expect that it will take approximately one year to manufacture Generx supplies for the clinical study at an
estimated cost of $5.0 million. In addition, once the final Generx study product is manufactured, Gene
Bio will be required to conduct a preclinical biodistribution study in preparation for the submission of the
Generx Biologics License Application (BLA) with the FDA.
(2) Comac Medical: We are planning to enter into an agreement with Comac Medical, which is located
in eastern Europe, to conduct our final FDA-cleared, Phase 3 clinical study. Comac Medical will be
conducting the study at up to 35 clinical sites, that will include approximately 30 sites in eastern Europe
and Turkey and approximately five sites in the U. S. Based on a recently completed geographic survey,
Comac believes that it is feasible enroll up to all 225 patients during a 12-month recruiting period following
the availability of Generx from FujiFilm Bio. Based on this current plan, we estimate that this clinical
study will cost up to $10.0 million. A copy of this plan, as prepared by Comac Medical, is included in this offering document.
You should reach out to Chris Reinhard and ask for information if you are an accredited investor and have $1 million to invest. The return on investment is amazing. They ae looking to raise $20 million as of the end of May.
It would be great to know how much has been secured and is there an investment banker promoting the deal. If so, who?
How are the current common sharehoders of CRXM going to be treated should a sale happen?
Is CRXM going to stay "private" or get back to trading again and if so, which market?
Still have hope? I’d say it’s a glimmer at best. As far as I understand it, there are a limited number of units for sale with a huge return on investment for those investors should we get approval or a buy out which is what is more likely.
I’m not aware of any units being sold nor what investment bank is shopping it out if any.
I was hoping someone here would provide some updates cause CRXM sure as shit isn’t.
The 10-k???
Anyone heard anything regarding a newish private placement offering to raise $20M for the Generx Phase 3 study?
Didn’t last as usual
From March. The last paragraph is beyond bizarre considering what is known publicly:
LOS ANGELES, CA / March 6, 2024 / Pacific Ventures Group, Inc. (OTC PINK:PACV) (“Pacific Ventures” or the “Company”), a food and beverage holding company specializing in the distribution of consumer food, beverage and alcohol-related products, today announced that, in furtherance of the success of its ongoing balance sheet restructuring, the Company has completed payments on its long-standing debt obligation to BNA Investment Capital, LLC and TRA Capital, LLC.
“We are excited and proud to have paid off what started out as a $400,000 debt to BNA and TRA, and it reinforces our commitment to, and the success of, our ongoing balance sheet restructuring efforts,” stated Shannon Masjedi, President and CEO of Pacific Group Ventures.The fully repaid obligation to BNA Investment Capital and TRA Capital relates to a settlement agreement that arose from litigation that began in 2020.
“Our recent successes in restructuring our balance sheet have begun to yield increased cash flow available for our operations, which, we are convinced, will place our operating subsidiaries in a more favorable posture for increasing sales.” This further prepares and aligns with the Company’s goal of moving to a higher trading platform in the near future.
Same for me for quite some time now. As far as I know no one has gotten a response recently.
318K shares for sell at eleven cents. Right about my cost average. Prefer to sell all to one investor if possible. This is a modest chunck of my holdings. It is actually in an account I set up for my son a long time ago. Since I had to retire quite early due to health problems from Covid-19, I need to raise money to get him through college.
VANCOUVER, Washington, May 16, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
I write today to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), as we approach the end of our 2024 fiscal year (May 31, 2024), and to sincerely thank you for your unwavering support.
Fiscal year 2024 was a significant year for CytoDyn, and one that I believe will be remembered as the beginning of a turnaround. The Company achieved the lifting of the FDA’s clinical hold in late February 2024 and is now working to return to the clinic. Over the past several months, the Company has made significant internal progress on key initiatives which we believe will lead to marked external developments in the form of the commencement of clinical trials, the rollout of a number of pre-clinical research initiatives, and the continued publication of leronlimab data.
Shortly after my appointment as the Company’s CEO in November 2023, I hosted an investment update at which I committed to prioritizing the following: (i) getting off clinical hold, which required the submission of a revised trial protocol to the FDA; (ii) publishing clinical data that had not yet been released; and (iii) exploring how to extend leronlimab’s platform wherever it made sense. As I reflect on my first six months as CEO, I am pleased with the progress, but our work is not yet done.
Over the next six months, we expect to commence at least one, and potentially two clinical trials. The prospective clinical trials, in order of priority, are: (i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and (ii) a Phase II study exploring leronlimab’s effects on inflammation. The Company’s priority will be the oncology trial which, if successful, will put us on track towards a commercial approval of leronlimab in that indication. The inflammation study is aimed at clarifying certain provocative observations related to leronlimab, and to help define the dose and underlying mechanism of anti-inflammatory action. It is imperative that the Company generate unassailable results in the clinic and I believe the above trials can accomplish this. Starting the oncology study and related fundraising is the top priority of the Company at this time, but our current hope is that we can initiate both studies before the end of this calendar year.
Research and development partnership opportunities are important to the Company as we search for cost-effective ways to further build out our product development portfolio. We have identified several such opportunities that we believe are intriguing, and anticipate finalizing agreements with these partners in the very near future. Such potential partnerships include an investigator-initiated pilot study of leronlimab in patients with Alzheimer’s Disease, and a project that will evaluate the use of leronlimab in patients living with HIV who are undergoing stem cell transplantation in a proof of cure study. Following lifting of the clinical hold, we have observed a significant increase in third parties that are interested in partnering with the Company. We will continue to review opportunities as they arise, given the potential for significant value return at little or no cost to the Company.
Finally, as promised, CytoDyn has submitted several leronlimab manuscripts for peer review and is in the process of completing final drafts of several others. The clinical endpoint data from the Long COVID trial (CD 15) was recently published in the Journal of Infection. All publications will be available on the Company’s website soon after publication.
I believe the Company is building for success and has made significant strides toward initiating a number of key pre-clinical and clinical leronlimab trials. I am also pleased to share that things are progressing well as to the development of a longer-acting therapeutic with our partner who utilizes its proprietary artificial intelligence platform.
As shareholders, you are the lifeblood of the Company and we remain committed to acting in your best interests. Your questions and feedback are always appreciated. Included herewith is a copy of the May 2024 “Frequently Asked Questions” supplement. This FAQ supplement is something that is also posted on the Company’s website and updated from time to time. You are always welcome to submit questions to the Company’s IR email account: ir@cytodyn.com.
I understand that the Company’s historical challenges may have tested your confidence, and I am grateful for your ongoing support and trust. My dedication to the Company is founded in my belief that leronlimab has the potential to be a life-changing therapeutic. As always, our commitment is to bring better healthcare to patients in need, and to maximize shareholder value.
Sincerely,
Dr. Jay Lalezari
CEO
Given the debt problem wake alerts us about and the current share price something has to give. Lack of management providing clear communication to current shareholders is disturbing. No way I'd get involved as a potential new buyer. Shannon and company have given no reason to think they can turn this around yet.
A month later and still nothing from CRXM.
Item 1.02 Termination of Material Definitive Agreement.
On April 3, 2024, CytoDyn Inc. (the “Company”) and Samsung BioLogics Co., Ltd. (“Samsung”) executed an agreement (the “Letter Agreement”), wherein the parties reached agreement for an orderly process for winding down services and a restructuring of the amount payable by the Company to Samsung (the “Total Balance”). The Letter Agreement resolves the Company’s obligations under the Master Services Agreement and related ancillary agreements first entered into between Samsung and the Company in or around April 2019 (collectively, the “Agreement”).
The Total Balance due as restructured under the Letter Agreement is $43,821,231.32. Except for a single $250,000 payment due on or before December 31, 2024, the entirety of the Total Balance is contingent, and will only be due and payable, upon the Company achieving a qualifying “Revenue” event, as defined in the Letter Agreement. Under the Letter Agreement, the Company agreed to pay 20% of its qualifying Revenue generated in each calendar year, if any, with such payments to be applied to reduce the Total Balance until it is repaid in full. Interest will not accrue on the Total Balance throughout the prospective repayment period. Revenue is defined in the Letter Agreement as:
“…the gross revenue generated by Client and its Affiliates, less the following items (if not previously deducted from the amount invoiced): (a) reasonable and customary trade, quantity, and cash discounts actually granted and legally permitted wholesaler chargebacks actually paid or credited by Client and its Affiliates to wholesalers of products; (b) reasonable, customary, and legally permitted rebates and retroactive price reductions actually granted; (c) freight charges for the delivery of products; (d) the portion of the administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers and/or government-mandated Medicare or Medicaid Prescription Drug Plans relating specifically to the product; and (e) sales, use or excise taxes imposed and actually paid in connection with the sale of products (but excluding any value added taxes or taxes based on income or gross receipts).”
As part of the wind down process under the Letter Agreement, at the discretion of the Company, Samsung will arrange for the shipment of specified drug product, substance and reference standards previously manufactured and/or utilized by Samsung to a storage facility selected by the Company. Any vials and/or batches of drug substance and drug product the Company elects not to ship and store at an alternate vendor will be destroyed.
Under the original Agreement between the parties, Samsung performed non-exclusive services relating to technology transfer, process validation, manufacturing, pre-approval inspection, vial filling, and supply and storage services for leronlimab bulk drug substance and drug product. Samsung was one of several companies the Company engaged for such services. The Company believes it currently has enough drug product and substance to complete its contemplated clinical activity and will be transitioning the aforementioned services to one, or several, of its current service providers.
Late filing notice out per usual.
Thanks JJ24 for reaching him and reporting here. Did he provide anything about how he was going about buying back the company?
Additionally, whoever is funding the buyout beyond Chris, what is their interest in getting the company back to being current in the SEC fikings and trading which is going to have a significant cost. Or do they plan on not being a public traded company?
Then there is the several million dollars needed to fund the trial.
Any idea if CRXM responded to the order?
They have let the website sevices go to shit. Not that they would have posted the info anyway. That would show at least some responsibility on their part to keep investors informed.
https://genebiotherapeutics.com/press/
https://genebiotherapeutics.com/investors/
The lack of communication is astonishing. WTF is the plan besides touting oneself as the the most respected woman in meat Shannon?
I saw that. Interesting that is equal to the rest of the days trading volume.
I sent yet another email to Shannon this AM. No answer. Big surprise.
...and the price of PACVD shares are going in the shitter
Good question. Most likely answer is money. I'm sure it's going to take hundreds of thousands to get current.
If Nostrum isn't able to provide financial support then what good are they? My expectattion was they could fund the trial directly or had resources to get the financing. Perhaps no lender will work with them given their situation. Enough time has passed I'd hoped Chris would have found a way to move things along without Nostrum.