Still waiting on our big moment and it feels like it has taken the full length of my investment (2/19 to now) to get from full enrollment of CD12 to any sort of announcement. It's brutal.
But I get it.
Data needs to be unlocked and scrubbed. Gotta get behind the ears, tickle the balls. Fresh and clean, ready for Amarex analyst screens.
Don't sleep on the unlocking part either.
I hear it's a very difficult lock to open. Old-timey, even. You try all of the normal methods but eventually you have to call in the big guns. I'm talking the cast of Ocean's 11. They're the only ones capable of pulling it off. Through a sexy mix of cunning, pizazz, and one small, flexible Asian character they'll get it done. After defeating all of the security measures they simply use Don Cheadle to pick the lock. He's tiny enough to be the tension rod.
Seriously.
I met him in real life while at the Playboy Mansion and he's miniature. Also, I spent some time hanging out with Shannon Elizabeth but those stories are for another post.
At this point the data should have already been scrubbed to a luster befitting a military boot. The lock fully obliterated, allowing the data to just swing it's girthy mortality numbers freely in the breeze. Anyone with a scientific calculator can take a break from typing BOOBIES into it and figure out if Leronlimab works.
So where is our press release, Nodder?!?
Seriously.
I'd take anything at this point.
How many logoed coffee mugs do we have in stock? PR that! Are they left-handed? Right-handed? UNISEX?!?
I have it on good authority that NP bought 2,000 mugs but had to order 2,000 more from a different supplier after realizing the originals were made in Wuhan. Bad optics. But I heard he bought so many because he only uses them once before writing the name of a short on the bottom and smashing it to pieces with his fists. Nobody buys that many mugs if expenses are a concern. Which leads me to believe Nader KNOWS we have money coming in. IT'S A BUYING SIGNAL!
New HVAC in the building? PR THAT SHIT!
Bro, my buddy is cousins with the janitor at Cytodyn's building. He told me they just put in a new HVAC system and ran the tenant on the floor above Cytodyn out of the building. They must know something. They're prepping the building for expansion! Someone must have overheard the CD12 results while cleaning the bathrooms and told the landlord. He's fixing things to cash in on that growth, baby! NO LANDLORD EVER FIXES ANYTHING IT'S A BUYING SIGNAL!!!
Shit, just PR a future PR. I don't care at this point.
Cytodyn, a late stage biotechnology company developing Vyrologix for use in HIV, Covid-19, Cancer, and 62 other indications available at Investorshangout.com/OHM20 has announced that next week the company will release a press release detailing the quantity and purchase price of almost 5,000 logoed coffee mugs. Originally a purchase of 2,000 mugs, the company found an issue with the original batch and authorized the immediate approval of an additional 2,000 mugs to be acquired via Cytodyn's partner in the Philippines, Chiral Pharma. "We are excited to announce that our partnership with Chiral Pharma has finally paid off the way we envisioned. These mugs will be of a like kind quality at less than half the price. Not that we need to conserve cash as our CD12 results are outstanding...oh wait, I need you to strike that from the record. I'm not supposed to talk about that yet it's a secret. ALL I HAVE LEFT ARE MY SECRETS!"
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in early February 2021.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn was conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company suspended its Phase 2 trial for acute GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to refile its Biologic License Application (“BLA”) for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the filing. CytoDyn expects to refile its BLA in the first half of calendar year 2021.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
mmulholland@cytodyn.com
But I get it.
Data needs to be unlocked and scrubbed. Gotta get behind the ears, tickle the balls. Fresh and clean, ready for Amarex analyst screens.
Don't sleep on the unlocking part either.
I hear it's a very difficult lock to open. Old-timey, even. You try all of the normal methods but eventually you have to call in the big guns. I'm talking the cast of Ocean's 11. They're the only ones capable of pulling it off. Through a sexy mix of cunning, pizazz, and one small, flexible Asian character they'll get it done. After defeating all of the security measures they simply use Don Cheadle to pick the lock. He's tiny enough to be the tension rod.
Seriously.
I met him in real life while at the Playboy Mansion and he's miniature. Also, I spent some time hanging out with Shannon Elizabeth but those stories are for another post.
At this point the data should have already been scrubbed to a luster befitting a military boot. The lock fully obliterated, allowing the data to just swing it's girthy mortality numbers freely in the breeze. Anyone with a scientific calculator can take a break from typing BOOBIES into it and figure out if Leronlimab works.
So where is our press release, Nodder?!?
Seriously.
I'd take anything at this point.
How many logoed coffee mugs do we have in stock? PR that! Are they left-handed? Right-handed? UNISEX?!?
I have it on good authority that NP bought 2,000 mugs but had to order 2,000 more from a different supplier after realizing the originals were made in Wuhan. Bad optics. But I heard he bought so many because he only uses them once before writing the name of a short on the bottom and smashing it to pieces with his fists. Nobody buys that many mugs if expenses are a concern. Which leads me to believe Nader KNOWS we have money coming in. IT'S A BUYING SIGNAL!
New HVAC in the building? PR THAT SHIT!
Bro, my buddy is cousins with the janitor at Cytodyn's building. He told me they just put in a new HVAC system and ran the tenant on the floor above Cytodyn out of the building. They must know something. They're prepping the building for expansion! Someone must have overheard the CD12 results while cleaning the bathrooms and told the landlord. He's fixing things to cash in on that growth, baby! NO LANDLORD EVER FIXES ANYTHING IT'S A BUYING SIGNAL!!!
Shit, just PR a future PR. I don't care at this point.
Cytodyn, a late stage biotechnology company developing Vyrologix for use in HIV, Covid-19, Cancer, and 62 other indications available at Investorshangout.com/OHM20 has announced that next week the company will release a press release detailing the quantity and purchase price of almost 5,000 logoed coffee mugs. Originally a purchase of 2,000 mugs, the company found an issue with the original batch and authorized the immediate approval of an additional 2,000 mugs to be acquired via Cytodyn's partner in the Philippines, Chiral Pharma. "We are excited to announce that our partnership with Chiral Pharma has finally paid off the way we envisioned. These mugs will be of a like kind quality at less than half the price. Not that we need to conserve cash as our CD12 results are outstanding...oh wait, I need you to strike that from the record. I'm not supposed to talk about that yet it's a secret. ALL I HAVE LEFT ARE MY SECRETS!"
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in early February 2021.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn was conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company suspended its Phase 2 trial for acute GvHD.
About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to refile its Biologic License Application (“BLA”) for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the filing. CytoDyn expects to refile its BLA in the first half of calendar year 2021.
CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
CONTACTS
Investors:
Michael Mulholland
Office: 360.980.8524, ext. 102
mmulholland@cytodyn.com
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