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Is it your opinion that the RS will pass because the insiders have or will have a greater percentage of the the Preferred Shares to vote?
Soligenix's pipeline and assets are way undervalued by the market IMO. With a solid Balance Sheet and by carefully managing expenses, the company is now in an advantageous position to dramatically enhance its value. It is incredible that the stock is selling for $0.66+/- a share and has not been acquired or strategically aligned with a major Pharma company.
Submission of the NDA is a true milestone and accomplishment for the Soligenix Team.
Bravo Zulu!
A peer reviewed article reporting successful Phase 3 results in a JAMA publication is a reasonable predictor of eventual FDA approval. IMHO, the JAMA publication is a significant milestone and harbinger of good things to come for SNGX.
HyBryte(TM) Phase 3 FLASH Study for the Treatment of Cutaneous T-Cell Lymphoma Published in JAMA Dermatology
11:17 AM ET 7/20/22 | Dow Jones
-- Published findings demonstrate that HyBryte(TM) treatment statistically
significantly reduced CTCL lesion size
-- HyBryte(TM) has potential to address a critical gap in treatment of
early-stage CTCL
PRINCETON, N.J., July 20, 2022 /PRNewswire/ -- Soligenix, Inc. (NASDAQ: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the results of its successful Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating HyBryte(TM) (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) has been published in the Journal of the American Medical Association (JAMA) Dermatology.
"The peer reviewed publication of these data in JAMA Dermatology is a testament and further validation to the importance of the findings for the scientific and CTCL disease communities," stated Ellen Kim, MD, Professor of Dermatology and Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study. "With its chronic course and major impact on patient quality of life, CTCL is an orphan disease in urgent need of additional treatment options that are well-tolerated and safe over the long haul. The results from this Phase 3 study, which is the largest double-blind, randomized, placebo-controlled trial in CTCL to date, represents an important leap forward in the development of potential therapies to meet this unmet medical need."
The published findings demonstrate that HyBryte(TM) treatment statistically significantly reduced lesion size, with the treatment response further improving over successive 6-week treatment cycles. The primary endpoint evaluated the CAILS (Composite Assessment of Index Lesion Severity) score of three treated index lesions and success was defined as >=50% reduction in CAILS score relative to baseline. Lesion response continuously improved with treatment duration. After the first 6-week treatment window, 16% of patients had a response (p=0.04 versus patients with 6 weeks of placebo treatment; primary endpoint). This response rate continued to significantly increase to 49% through 18 weeks of treatment (p<0.0001 versus patients with 6-week hypericin or placebo treatment). Throughout the study, HyBryte(TM) was safe and well-tolerated. Importantly, HyBryte(TM) was observed to perform similarly against both patch and thicker plaque lesions characteristic of CTCL.
"In treating CTCL, which is a chronic cancer with no cure, long-term safety is of paramount concern. Most current treatment options for CTCL are associated with significant safety concerns, including black-box warnings. HyBryte(TM) treatment has demonstrated strong and rapid efficacy with a very benign safety profile," stated Dr. Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "This is of significant benefit to patients living with this difficult disease. The substantial increase in efficacy with longer treatment and the similar performance against both patch and plaque lesions are particularly encouraging. As one of the largest studies in CTCL, this study and this publication establishes a new benchmark in CTCL treatment."
About JAMA Dermatology
JAMA Dermatology is an international peer-reviewed journal published online weekly and in print/ online issue 12 times a year. It is one of the highest ranked journals in dermatology, with an acceptance rate of 9%. The journal, which has been in continuous publication since 1882, publishes studies in the areas of medical, surgical, pediatric, geriatric dermatology, oncologic and aesthetic dermatology. It prioritizes clinical and laboratory studies that reveal new information pertinent to the interests and needs of the medical dermatologist, dermatologic surgeon, and all those concerned with state-of-the-art care of cutaneous disease. The journal believes that knowledge derived from well-designed clinical trials and studies of cost-effectiveness are especially important for improving the practice of dermatology. JAMA Dermatology is a member of the JAMA Network family of journals, which includes JAMA, 11 JAMA Network specialty journals, and JAMA Network Open.
It is true, for longterm shareholders, the stock has performed poorly, however, the basic science is sound and if the company actually files the NDA this year, the future is promising. No illusions, the regulatory path ahead is no walk in the park, but it looks doable. With FDA approval and the extremely low "float", the risk/reward is quite attractive.
I have been following this company for years and believe there is real value in the company's IP. Assuming, there are no hiccups with regard to submitting the NDA (for the treatment of Cutaneous T-Cell Lymphoma) later in the year, the SP should recover to previous level of $2 - $3, at the very least.
If the company wants the Activist Group to submit their proxies than they should consider them valid votes and recognize the result if the Activist Candidates win.
BoD must remove Nader Pourhassan and seek support from disaffected shareholders in order to secure new financing. IMHO, that is the only way forward.
IncellDx is a private company and may wish to remain so.
I don't know what statement you are referring to, but will gladly review it if you would like to provide me a copy. Thanks!
I wouldn't know whether IncellDx is a good investment or not, as it is a private company and I have no knowledge or information to support an opinion.
Obviously, there were folks who believed both companies were worthy of support.
I have seen no evidence that there is a conspiracy to acquire IncellDx if the Proxy Candidates win. I believe that is a rumor, a "red herring", to distract, misinform, and frighten shareholders. Were there discussions in the past between IncellDx and CytoDyn? Of course, that is well documented, but they led nowhere and the matter was dropped. I have participated in and/or watched all the Zoom calls and never heard the subject discussed.
The Amarex debacle is on Nader Pourhassan for choosing them as a CRO. I seem to remember something about him being friends with the Amarex CEO, but could be mistaken about that. Poor choices, errors in judgement, and operational inexperience do not a CEO make. Truth is a bitter pill to swallow and Nader Pourhassan should look in the mirror, admit his shortcomings, and resign as CEO for the good of all stakeholders. A dignified departure would be a step in the right direction and honor the efforts of employees who are trying to make things right.
Regarding CytoDyn, I keep picturing the final scene in the movie "Thelma & Louise" when they are surrounded by the police and all hope is lost, they decide to "go for it" and drive right off the cliff into the Grand Canyon. Folks, if the Proxy Candidates don't win the election, I fear shareholder equity will go the way of "Thelma & Louise". Therefore, I am solidly behind the Proxy Group's Candidates and hope any of you who are still undecided will see your way to consider supporting them, as well.
I have been hoping for a negotiated settlement which would avoid the likely SP trauma following the Proxy Contest, but that solution looks like a lost cause.
That said, whichever slate wins, all shareholders regardless of how they voted, will be needed to support the company moving forward. The eventual FDA Approval of Leronlimab is too important to let partisanship compromise that objective. I hope the Proxy Candidates win, but if they don't, I will do everything I can to help the company succeed, in spite of my disappointment.
Cynmark24, I have known Paul Rosenbaum for many decades and can assure you he has what it takes to lead the BoD, recruit a terrific CEO, and give Cytodyn a fighting chance of success. Additionally, my interactions with Drs. Patterson and Errico give me the utmost confidence in their professional acumen and sincerity. I do not know the other candidates personally, but if Paul Rosenbaum is good with them, so am I.
Thanks Closet, I think it is so important to know how the company got to where it is today and the reasons it has been and still is burdened with toxic debt. A true inflection point was possible when Ziff and Bain, with Paulson's support, offered major investment banking funding, likely uplisting, and competent leadership. Regrettably, Nader Pourhassan rejected that support and chose Fife. IMO, with a Proxy Slate win, we have a good shot at salvaging the future of Cytodyn.
I received a few PMs requesting a link to the Proxy Group's Zoom Call last week. While I do not have a link to the full meeting, there is a slide summary of Dr. Errico's presentation on The Advancing Leronlimab website. Whether you are a supporter or detractor of current management or the Proxy Group, you owe it to yourself to be fully informed.
https://www.advancingll.com/crossroads
I do think Dr. Errico is reliable, but understand that you don't. Assuming you believe Nader Pourhassan is reliable, why not ask him about the meeting, who was there, and what was presented? I don't think Scott Kelly was present, but you can ask him whether he has a take on what went down.
You know very well that weaponizing someone's prior support and encouragement that was later found to be misplaced by poor decisions and execution failures is reprehensible. I prefer that you contact Dr. Errico for details regarding who was at the meeting. You might be surprised by what you learn.
The PR did not present definitive facts, so I see no hypocrisy. As far as I know, the review of the 2019 meeting was based on first hand knowledge which I found it credible. I don't know if a link to the Zoom call is available, but if so, why not watch it and decide for yourself.
A PR from one side of a disagreement does not constitute conclusive validation, it is certainly one version of events. Another is that Cytodyn approached Patterson, not the other way around.
To my knowledge, the issue of the IP was not mentioned, but I do not think the BoD at that time would have agreed to allow it to be collateral for financing. Following the meeting referenced by Dr. Errico, Nader Pourhassan managed a reconstitution of the Board which allowed him to act unilaterally without proper oversight, at least that is the impression I got. With Scott Kelly and Jordan Naydenov's support, Pourhassan effectively neutralized the Directors responsible for audit and compensation oversight. The results of progressing without proper controls are in the operational and legal record. Not a pretty sight.
Generally Cancer Trials are very expensive to run and can last years to yield meaningful results, but I do not have any reliable information as to Cytodyn's cancer strategy, so I am afraid I cannot offer anything useful.
Excellent question. I do not know the terms of the deal Bain and the other IB were contemplating, though it is hard to fathom that it would turn out to be worse than what has transpired with Fife. That would be a good question to ask Nader during one of the future CCs.
That's about right, Nader turned down Bain Capital and another IB so that he could keep his job as CEO. BTW, according to Dr. Errico, Nader Pourhassan was going to be "taken care of" with a less visible position if he chose to remain in the company. It wasn't as if they were going to put him on the street. The IBs did not believe that Nader Pourhassan could continue to be the "face of the company" and expect institutional support and/or uplisting which was required to secure funding at a market rate. Dr. Errico went on to say that after the IB representatives left, Nader took the seat of one of them and proceeded to mock them. Can you imagine the benefit to the shareholders if it was announced that two highly respected IBs were funding the cancer trials? Wow, talk about missed opportunities!
Sorry, I don't have access to the dialogue (it was a bit long) or the link to the Zoom call, but the basic idea was that Fife loaned us "$1.00", but we only received $0.87 of that $1.00, but had to pay back the $1.00 plus interest on the $1.00 resulting in our paying back $1.29. Even worse, without any explanation from the Company, Fife and Cytodyn ignored the original repayment terms to the detriment of the company.
The Zoom call last night provided the answer for why Cytodyn chose to borrow from Fife when they had a been offered $50MM - $60MM from Bain Capital and another top tier IB to fund the cancer trials in 2019. The explanation could not be simpler, Fife would do the deal and allow Pourhassan to remain CEO. Bain and the other IB required that he change roles and bring in a CEO. Paulson offered to help with a referral to two other IBs, but was apparently ignored. The details of the informal BoD meeting where the above was discussed is reviewed in detail by Dr Errico during the Zoom call. Whether you support Nader Pourhassan's slate or not, you owe it to yourself to be informed. if you have not already done so, check out the Zoom call, . Additionally, there is a hypothetical "dialogue" between Cytodyn and Fife which is presented by Mr Wilmes detailing how the company was "fleeced". The "dialogue" would be entertaining if the content did not represent the outrageous waste of shareholders equity.
Does anyone else find that Nader Pourhassan "weaponizing" Paul Rosenbaum's encouraging and supportive email during the Emerging Presentation reprehensible? Just hard to imagine anyone having the nerve to do that, knowing full well that their actions during the last year had dramatically changed that person's opinion. IMO, at best, Nader's displaying the emails was terrible judgement, at worst, it represented very poor character and was insulting to shareholders who deserve better.
8-Ks are required by the SEC when companies and/or other entities owning a certain level of shares make or release public statements. It is in place to insure that all shareholders have access to the information. It is burdensome and costly for all parties and is a significant impediment to activist shareholder groups with limited funds and resources. I don't believe anyone likes it, but theoretically is good for shareholders.
While I don't purport to know what the FDA will do, think, or what its attitude will be with a new Board and CEO, I don't think it can get any worse. I have heard nothing to support the idea that Clinical Trials will be held up by the new Board, but perhaps you have nonpublic information to the contrary. If so, please share it, thanks.
Only the shareholders can sell CytoDyn, not the Board and not the future CEO. The Proxy Group is interested in developing the full value of the company. To do that, a competent CEO with credibility is required. While Pourhassan has shown "true grit" to this point, a different type of leader and face of the company is now needed.
Rosenbaum has stated that he is not interested in becoming CEO. The new Board will recruit and select a world class CEO to execute the company's business and clinical plan.
I get that name calling, personal attacks, deflection, and misinformation are becoming the norm on social media, but would someone who supports Nader Pourhassan offer a rational explanation as to why he and the Audit Committee allowed Fife to disregard the terms of the Convertible Notes to Fife's benefit without a corresponding benefit to the company. The argument that the Fife deals were the best available does not hold up because the original terms were not honored. I just don't get it!
Just finished reading the "White Paper" detailing the Fife Loans. First, the terms were massively unfavorable to the company, but worse those terms were violated to the benefit of the lender without the company receiving a quid pro quo. The result was dilution and allowed the lender to short the stock with impunity if he chose.
Second, why did Nader Pourhassan and the audit committee allow this to happen? IMO, a simple straightforward sale of stock to the public would have been less dilutive and less expensive. The Fife deals are at best financial incompetence and at worst_________(fill in the blank).
Agreed and the Proxy Group’s Cancer plan is the “scalpel”.
There is no equivalence between licensing a test from Incelldx and acquiring or merging the company. I was on every Zoom call and never heard any mention of such a transaction.
BTW, I did not criticize him for not revealing his compensation, as it was cheeky question, however, he should have disclosed his relationship with Cytodyn when he started the "group". Of course, since Cytodyn is a public company, that information had to be made public, which it was.
Cytodyn disclosed that his company was being paid which he admitted, but demurred to reveal how much he was being compensated. when someone asked him how much he was receiving. That person was "deleted". Ask him directly if you don't believe it.