Humanigen Inc (HGEN) 銘柄情報

The PDUFA date is in April for Novavax's BLA.

see slide 41
https://novavax.widen.net/s/wggdm8jtjb/novavax-jan-2025-corporate-deck

It would be nice to have a lenz-enhanced protein-based covid vaccine be the first to be FDA approved.

It appears that the Novavax/Sanofi Covid Influenza Combination (CIC) product could take up to 12 months to complete the Phase I/II trials.

"The trial is expected to last approximately 12 months and consist of a dose escalation with sequential enrollment."

see next to the last paragraph
https://www.pharmacytimes.com/view/fda-grants-fast-track-designations-to-2-combination-influenza-and-covid-19-vaccine-candidates

I don't know where our PREACH-M and RATinG trials are for CMML and aGvHD. I thought we would have heard something by now on those trials.

My anger does nothing but intensify each day that the DOJ actually aids and abets the willful negligence of the FDA in permitting the continued incidents of preventable deaths. It is inexcusable that lenzilumab is prevented from saving those lives.

I see where Invivyd is trying to amend their EUA for the use of Pemivibart as a pre-exposure prophylaxis, to be expanded for the treatment of mild to moderate covid.

https://investors.invivyd.com/news-releases/news-release-details/invivyd-provides-another-positive-sars-cov-2-variant-data

I decided to look at their trial design, which qualified them for the EUA, and I see that 790 people were enrolled in the trial.

https://clinicaltrials.gov/study/NCT06039449?intr=pemivibart&rank=1

That compares to Humanaigen's LIVE-AIR trial of 520 patients enrolled.

https://clinicaltrials.gov/study/NCT04351152?intr=lenzilumab&rank=3
.
However, Invivyd had two cohorts they were testing, people who were immuno-compromised, and those who weren't.

In addition, I don't see where pemivibart was IND-authorized. So lenz may have more safety and efficacy data than pemivibart. I could be wrong, and there may have been two trials. But just based on what I looked at, I think management was justified in submitting our EUA request. And certainly, with the peer-reviewed results lenz demonstrated, management's request for an EUA should not have constituted a criminal act.

To me, the Wellerman song has kinda become our theme song. "One day, when the toungin'* is done, we'll take our leave and go." We're not the Weller Brothers, running a small fleet of cargo ships in the 19th century, fraught with dangers including whale attacks. But we are a small company under attack by bully boys entrenched in a swamp. The beat is addictive, and the cheerleaders are amazing, and it's just another feel good experience.

https://www.youtube.com/shorts/jNHTt1EbdGk

*tounging: means harvesting blubber from whales, in this case

First read-through kind of reminds me of the RATinG study, in terms of the goal. GvHD is so cruel. Good luck to SANA.

Was shareholder of HGEN back during covid madness. Respect the knowledge on this board. SANA opinion needed on Type 1 diabetes PR:

Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
January 07, 2025 16:05 ET
| Source: Sana Biotechnology, Inc

Share






First-in-Human Study Provides Evidence that Sana’s Hypoimmune (HIP) Technology Enables Transplanted Islet Cells to Avoid Immune Rejection and Produce Insulin Without Immunosuppression

Results Demonstrate HIP-Engineered Primary Pancreatic Islet Cells Avoid Immune Detection, Function, and Persist after Intramuscular Transplantation in First Treated Patient with Type 1 Diabetes

Function and Persistence of Pancreatic Islets Were Detectable by Production of Consistent Levels of Circulating C-Peptide, a Marker of Insulin Production, and Increased C-Peptide Levels with a Mixed Meal Tolerance Test (MMTT)

MRI Shows Signals Consistent with Graft Survival 28 Days after Transplantation

Study Continues to Evaluate Safety, Persistence, and Function of Transplanted Cells

Conference Call to be Webcast at 1:30pm PT

SEATTLE, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced initial results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression. The study was conducted in partnership with Uppsala University Hospital. Results of the study at four weeks after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. MRI scanning also demonstrated a sustained signal at the site of transplanted cells over time, which is consistent with graft survival. The study identified no safety issues, and the HIP-modified islet cells evaded immune responses.

“These initial exciting results build upon the extensive preclinical and translational studies of Dr. Sonja Schrepfer and the team at Sana. The clinical data are highly promising for patients and provide the first evidence in humans for overcoming allogeneic and autoimmune rejection with pancreatic islet cell transplantation in type 1 diabetes with no immunosuppression,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. “In type 1 diabetes, a person’s immune system attacks and destroys the beta cells. Today’s data, when combined with progress elsewhere in the field, provide real hope that a scalable, curative treatment for patients with type 1 diabetes, meaning normal blood glucose with no insulin injections or immunosuppression, is possible. We look forward to longer follow-up and plan to submit study results for publication as well as for presentation at an upcoming scientific forum.”

“We achieved our goals for the study, identifying no safety issues as well as demonstrating survival, function, and evasion of immune detection of HIP-modified primary pancreatic islet cells transplanted intramuscularly with no immunosuppression,” said Steve Harr, Sana’s President and Chief Executive Officer. “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases. We view the insights from the current study as directly applicable to developing SC451, our HIP-modified, stem cell-derived pancreatic islet cell program for the treatment of type 1 diabetes. Thank you to everyone involved in this study.”

“These initial clinical results show that cell therapies that replace insulin-producing cells without immunosuppression are approaching reality as a meaningful and potentially life-changing cure for type 1 diabetes,” said Aaron J. Kowalski, Ph.D., CEO of Breakthrough T1D (previously known as JDRF). “We are proud to contribute to translational research endeavors such as those at Sana as a supporter and investor through the T1D Fund: A Breakthrough T1D Venture. We are extremely grateful for the collaborative efforts of the research teams at Sana, at Uppsala University Hospital, and all those involved, for their dedication to this work. We look forward to working with Sana and others to break down the remaining barriers to ensure all members of the T1D community can benefit from these life-changing breakthroughs.”

Primary islet cell transplantation with immunosuppression is an established procedure in type 1 diabetes in which allogeneic pancreatic islet cells are isolated from a deceased donor’s pancreas and transplanted into a patient with a goal of normal blood glucose control and insulin independence. As with whole-organ transplants, suppression of the recipient’s immune system has historically been required to prevent immune rejection of the allogeneic transplanted cells and resurgence of the inciting autoimmune attack. Sana’s HIP technology is designed to overcome immunologic rejection of allogeneic cells, and in type 1 diabetes, also to evade the autoimmune rejection of pancreatic beta cells. UP421 cells were transplanted with no immunosuppression, and the survival of the islet cells provides evidence that these cells evade both allogeneic and autoimmune detection.

Webcast Conference Call Information
Sana will host a webcast conference call to discuss results today, January 7, 2025 at 1:30 p.m. PT. The live webcast and audio archive of the presentation will be accessible on the Investor Relations page of Sana’s website at https://sana.com/. The call can be accessed by dialing (877)-346-6112 (domestic) or (848)-280-6350 (international) and referring to conference ID 9582416.

About the Uppsala University Hospital Investigator-Sponsored Study of UP421 in Type 1 Diabetes
The investigator-sponsored study of UP421 is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust. The study tests the hypothesis whether HIP-engineered insulin-producing pancreatic cells can be transplanted safely and help to regain insulin production in individuals with type 1 diabetes without need of simultaneous treatment with immunosuppressive medicines. To do this, UP421 is engineered using Sana’s HIP platform at Oslo University Hospital. The study involves intramuscular surgical transplantation of primary, or donor-derived, HIP-engineered islet cells into the forearm of patients with type 1 diabetes. The primary objective of the study is to investigate safety of UP421 transplantation in patients with type 1 diabetes, with secondary endpoints including cell survival, immune evasion, and C-peptide production. Circulating C-peptide is a measure of endogenous insulin production. This first-in-human study examines a low dose of HIP-modified primary islets to initially establish the safety and function of HIP-modified islets without immunosuppression and, as a result, is not intended to show improvement in glycemia and/or reduction in exogenous insulin administration.

Results of the study over four weeks after islet cell transplantation demonstrate the survival and function of pancreatic beta cells at each weekly blood draw, as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase during an MMTT, consistent with insulin secretion in response to a meal. At baseline, the patient had undetectable C-peptide both fasting and during an MMTT. MRI scanning demonstrated a sustained signal at the site of the graft over time, consistent with graft survival. The HIP platform has achieved proof-of-concept in humans, showing evasion of immune recognition with the potential broad application for allogeneic transplantation without immunosuppression.

About the Sana Biotechnology Hypoimmune (HIP) Platform
Sana’s HIP platform is designed to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression. We are applying the HIP technology to develop therapeutic candidates at scale, including pluripotent stem cells, which can then be differentiated into multiple cell types, including pancreatic islet cells, and donor-derived allogeneic CAR T cells. We and our collaborators have generated significant foundational intellectual property in the area. Early clinical data from Phase 1 trials and preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Sana’s most advanced programs utilizing this platform include stem cell-derived pancreatic islet cells for patients with type 1 diabetes, an allogeneic CAR T program for B-cell mediated autoimmune diseases, and an allogeneic CAR T program targeting CD22+ cancers.

About Sana Biotechnology
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, South San Francisco, CA, and Bothell, WA. For more information about Sana Biotechnology, please visit https://sana.com/.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the company’s vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its preclinical, clinical and regulatory development plans and timing expectations; the ability of Sana’s HIP platform to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression and, in type 1

Was shareholder of HGEN back during covid madness. Respect the knowledge on this board. SANA opinion needed on Type 1 diabetes PR:

Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
Sana Biotechnology Announces Positive Clinical Results from Type 1 Diabetes Study of Islet Cell Transplantation Without Immunosuppression
January 07, 2025 16:05 ET
| Source: Sana Biotechnology, Inc

Share






First-in-Human Study Provides Evidence that Sana’s Hypoimmune (HIP) Technology Enables Transplanted Islet Cells to Avoid Immune Rejection and Produce Insulin Without Immunosuppression

Results Demonstrate HIP-Engineered Primary Pancreatic Islet Cells Avoid Immune Detection, Function, and Persist after Intramuscular Transplantation in First Treated Patient with Type 1 Diabetes

Function and Persistence of Pancreatic Islets Were Detectable by Production of Consistent Levels of Circulating C-Peptide, a Marker of Insulin Production, and Increased C-Peptide Levels with a Mixed Meal Tolerance Test (MMTT)

MRI Shows Signals Consistent with Graft Survival 28 Days after Transplantation

Study Continues to Evaluate Safety, Persistence, and Function of Transplanted Cells

Conference Call to be Webcast at 1:30pm PT

SEATTLE, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced initial results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression. The study was conducted in partnership with Uppsala University Hospital. Results of the study at four weeks after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. MRI scanning also demonstrated a sustained signal at the site of transplanted cells over time, which is consistent with graft survival. The study identified no safety issues, and the HIP-modified islet cells evaded immune responses.

“These initial exciting results build upon the extensive preclinical and translational studies of Dr. Sonja Schrepfer and the team at Sana. The clinical data are highly promising for patients and provide the first evidence in humans for overcoming allogeneic and autoimmune rejection with pancreatic islet cell transplantation in type 1 diabetes with no immunosuppression,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. “In type 1 diabetes, a person’s immune system attacks and destroys the beta cells. Today’s data, when combined with progress elsewhere in the field, provide real hope that a scalable, curative treatment for patients with type 1 diabetes, meaning normal blood glucose with no insulin injections or immunosuppression, is possible. We look forward to longer follow-up and plan to submit study results for publication as well as for presentation at an upcoming scientific forum.”

“We achieved our goals for the study, identifying no safety issues as well as demonstrating survival, function, and evasion of immune detection of HIP-modified primary pancreatic islet cells transplanted intramuscularly with no immunosuppression,” said Steve Harr, Sana’s President and Chief Executive Officer. “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases. We view the insights from the current study as directly applicable to developing SC451, our HIP-modified, stem cell-derived pancreatic islet cell program for the treatment of type 1 diabetes. Thank you to everyone involved in this study.”

“These initial clinical results show that cell therapies that replace insulin-producing cells without immunosuppression are approaching reality as a meaningful and potentially life-changing cure for type 1 diabetes,” said Aaron J. Kowalski, Ph.D., CEO of Breakthrough T1D (previously known as JDRF). “We are proud to contribute to translational research endeavors such as those at Sana as a supporter and investor through the T1D Fund: A Breakthrough T1D Venture. We are extremely grateful for the collaborative efforts of the research teams at Sana, at Uppsala University Hospital, and all those involved, for their dedication to this work. We look forward to working with Sana and others to break down the remaining barriers to ensure all members of the T1D community can benefit from these life-changing breakthroughs.”

Primary islet cell transplantation with immunosuppression is an established procedure in type 1 diabetes in which allogeneic pancreatic islet cells are isolated from a deceased donor’s pancreas and transplanted into a patient with a goal of normal blood glucose control and insulin independence. As with whole-organ transplants, suppression of the recipient’s immune system has historically been required to prevent immune rejection of the allogeneic transplanted cells and resurgence of the inciting autoimmune attack. Sana’s HIP technology is designed to overcome immunologic rejection of allogeneic cells, and in type 1 diabetes, also to evade the autoimmune rejection of pancreatic beta cells. UP421 cells were transplanted with no immunosuppression, and the survival of the islet cells provides evidence that these cells evade both allogeneic and autoimmune detection.

Webcast Conference Call Information
Sana will host a webcast conference call to discuss results today, January 7, 2025 at 1:30 p.m. PT. The live webcast and audio archive of the presentation will be accessible on the Investor Relations page of Sana’s website at https://sana.com/. The call can be accessed by dialing (877)-346-6112 (domestic) or (848)-280-6350 (international) and referring to conference ID 9582416.

About the Uppsala University Hospital Investigator-Sponsored Study of UP421 in Type 1 Diabetes
The investigator-sponsored study of UP421 is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust. The study tests the hypothesis whether HIP-engineered insulin-producing pancreatic cells can be transplanted safely and help to regain insulin production in individuals with type 1 diabetes without need of simultaneous treatment with immunosuppressive medicines. To do this, UP421 is engineered using Sana’s HIP platform at Oslo University Hospital. The study involves intramuscular surgical transplantation of primary, or donor-derived, HIP-engineered islet cells into the forearm of patients with type 1 diabetes. The primary objective of the study is to investigate safety of UP421 transplantation in patients with type 1 diabetes, with secondary endpoints including cell survival, immune evasion, and C-peptide production. Circulating C-peptide is a measure of endogenous insulin production. This first-in-human study examines a low dose of HIP-modified primary islets to initially establish the safety and function of HIP-modified islets without immunosuppression and, as a result, is not intended to show improvement in glycemia and/or reduction in exogenous insulin administration.

Results of the study over four weeks after islet cell transplantation demonstrate the survival and function of pancreatic beta cells at each weekly blood draw, as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase during an MMTT, consistent with insulin secretion in response to a meal. At baseline, the patient had undetectable C-peptide both fasting and during an MMTT. MRI scanning demonstrated a sustained signal at the site of the graft over time, consistent with graft survival. The HIP platform has achieved proof-of-concept in humans, showing evasion of immune recognition with the potential broad application for allogeneic transplantation without immunosuppression.

About the Sana Biotechnology Hypoimmune (HIP) Platform
Sana’s HIP platform is designed to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression. We are applying the HIP technology to develop therapeutic candidates at scale, including pluripotent stem cells, which can then be differentiated into multiple cell types, including pancreatic islet cells, and donor-derived allogeneic CAR T cells. We and our collaborators have generated significant foundational intellectual property in the area. Early clinical data from Phase 1 trials and preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Sana’s most advanced programs utilizing this platform include stem cell-derived pancreatic islet cells for patients with type 1 diabetes, an allogeneic CAR T program for B-cell mediated autoimmune diseases, and an allogeneic CAR T program targeting CD22+ cancers.

About Sana Biotechnology
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, South San Francisco, CA, and Bothell, WA. For more information about Sana Biotechnology, please visit https://sana.com/.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the company’s vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its preclinical, clinical and regulatory development plans and timing expectations; the ability of Sana’s HIP platform to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression and, in type 1 diabetes, enable transplanted islet cells to avoid immune rejection and produce insulin without immunosuppression; the potential implications of the data on the ability to find a scalable, curative treatment for patients with type 1 diabetes; expectations with respect to follow up and publication and presentation of the study results; the potential safety and survival, function, and evasion of immune detection of HIP-modified primary pancreatic islet cells transplanted intramuscularly with no immunosuppression; the potential of safe cell transplantation without immunosuppression to transform the treatment of type 1 diabetes and a number of other diseases; the potential application of the learnings from the study to the company’s SC451 program; the potential significance of the survival of the islet cells in the study; and the ability to apply the HIP technology to develop therapeutic candidates at scale, including both pluripotent stem cells and donor-derived allogeneic CAR T cells. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Quarterly Report on Form 10-Q dated November 8, 2024. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Investor Relations & Media:
Nicole Keith
investor.relations@sana.com
media@sana.com

Rich Allan, FGS Global
503-851-0807
rich.allan@fgsglobal.com



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I haven't seen any criminal charges filed against Durrant or the relief defendants named in the civil case. Have you?

I see an Indictment and a Second Indictment of Dale, both unsealed by the DOJ on December 23, 2024.

https://www.justice.gov/usao-nj/pr/former-executive-new-jersey-pharmaceutical-company-charged-38-million-insider-trading

https://www.justice.gov/opa/pr/chief-science-officer-publicly-traded-health-care-company-charged-insider-trading-scheme

But we know that a week later, on Dec 30, 2024, the SEC announced that civil charges against Dale AND Durrant and Relief Defendants had been filed on May 20, 2024.

https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26206

So the DOJ decided not to make the same cases the SEC made.

The crux of the issue is that the defendants acted upon having material non-public information. Material is defined as, "having real importance or great consequences (as in) facts material to the investigation."

https://www.merriam-webster.com/dictionary/material

The FDA should have Denied the EUA, if their expressed concerns were legitimate. The FDA should withdraw the IND Authorization for the use of lenz, which has been in force for almost five years now. The FDA should not be designating lenz products for FAST TRACK Approval, which I think they have done twice now.

Clearly, the FDA sees significant safety and efficacy benefit in the use of lenz, despite any claim they make to the contrary. Yet, it is that very claim that serves as the basis for the civil and criminal charges. The FDA's stated concerns are unfounded, not supported by a Denial of our EUA, and contravened by their own regulatory actions regarding IND Authorization, and FAST TRACK designation.

The DOJ decided not to bring charges against all the defendants named in the civil case, but there shouldn't be any criminal or civil charges at all.

"... it is just as possible to conclude that the FDA Declined our Denial..."

I can hear the DOJ's excuse now. 'We didn't consider the Decline's affect on the status of a Denial of the company's EUA application. We acted upon the FDA's information provided to us, which focused on their discussions with management over various concerns,' the most serious, to me, being unable to make a risk/benefit determination.

There will never be another case of this magnitude for any of the government personnel involved. Millions of lives are in the balance.

Has the SEC and the DOJ even challenged the FDA's expressed concerns? It's not outside of your purview in this case. You cannot reconcile the FDA's concerns with the facts. The FDA themselves quickly IND-Authorized lenzilumab in April of 2020 to treat covid, nearly five years ago. I also suspect there are recently two FAST-TRACK designations the FDA made to expedite the use of lenz in other applications.

There are no risk/benefit concerns expressed in Mayo Clinic's case cohort study, which, with lenzilumab's efficacy, led to them working with Humanigen's doctors/executives in the highly successful company-sponsored LIVE-AIR trial. A key take-away from the trial investigators was lenzilumab's safety profile. See the presentation of the Investigators' Meeting here:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175678449

Friendly reminder to all those visiting: Humanigen no longer exists, has no IP, their shares have been cancelled by FINRA, and thus do not exist. Your previous shares will remain visible in your trading accounts until the bankruptcy has concluded.

Pay no attention to speculation, disinformation around trials, partnerships, and like.

Anyone searching for information can find all relevant material surrounding the bankruptcy and sale of assets here: https://dm.epiq11.com/case/humanigen/info

Information surrounding the SEC vs. Dale can be found on PACER & Pacer Monitor

That is all. Cheers 👋

Thanks, dlog. To me, it is self-evident that management can not be held criminally liable, just because the FDA raised questions, and then Declined to review the evidence in the EUA application. That's all it took for criminal charges to be brought in this case. That would mean the FDA could act with impunity by hiding behind a Decline determination, which doesn't need to be justified, as a Denial would require.

Wife and daughter went to law school, but I was the only one who filed Motions or Objections, subpoenaed evidence, and argued a case which the judge thought I had, but I couldn't convince him of the damage Naked Shorting had on a company's equity financing capability. I found what I thought I was meant to do when I became a Special Investigator for the US Government for awhile after 9-11. But after some time, I knew I was ultimately interested in getting on the other side of investigations concerning the US Government. I'm still proud of the federal credentials I held, and I'd be happy to retake them as a contracted investigator, if our new Administration gets serious about things.

Haha i figured that would pull a trigger. Jay while i doubt you i would not have a problem if you were right.. 
if you were not a lawyer you missed a calling.
You make good arguments. 
Where the heck are cam and dale hiding at

STOP, dlog! Here's what the FDA tells us what a Decline determination means to them. It means that they are not going to review and process the EUA application. Period.

see the 1st bullet point
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-25-2021

If the material in the EUA application hasn't even been reviewed, then no conclusion can be derived about the likelihood of either a Denial nor an Approval, had the material been reviewed. The SEC and the DOJ therefore have no basis to conclude that the FDA Declined our Approval, when it is just as possible to conclude that the FDA Declined our Denial, since we are conflating determinations.

I want to stop right here for now, (but there is more to be said) because what I outlined means that there is no basis for the charges filed by the SEC and the DOJ, based on the FDA's decision to Decline the review and processing of our EUA application.

Decline synonyms 
Refuse ,reject ,deny

Decline means no .. they declined to authorize EUA. 
You think decline means they did not answer yes or no.
Jay ....they said no ....

Thanks Jay. The graphic did not show up on my phone but it did when I used the laptop.

Hi, eb!!

The link is overlayed on the coiled snake graphic.

Click on the rectangular prompt at the bottom left of the graphic to be able to watch a full screen presentation on YouTube.

I don't see the link, Jay.

The definitive evidence for Regulatory Approval of Lenzilumab is presented by the trial doctors who conducted the company-sponsored LIVE-AIR trial. Those results are presented and discussed by the trial investigators in the following 36 minute video. It should be noted that the first 10 minutes of the video discusses a case cohort study conducted by Mayo Clinic, as a pre-cursor to implementing the Phase III trial by Humanigen. Select the option to watch the video on Youtube.

"...the FDA had declined EUA approval..." the DOJ incorrectly claimed in their second Indictment. So, another example of conflated outcomes. It's an example of bias against management, even with a preponderance of evidence negating the FDA's expressed opinion as to the data, demonstrating a very favorable risk/benefit determination.

Even a rookie FBI agent should have had enough common sense to verify the validity of the FDA's stated concerns. This is especially true when the FDA's own actions demonstrate absolute support for lenzilumab, starting with granting Investigational New Drug (IND) authorization in April 2020, and continuing with FAST-TRACK designation for Novavax and Sanofi lenz-enhanced (?) vaccines, awarded as recently as two weeks before the DOJ's second Indictment.

Then, there is the issue of third party verification of lenzilumab's safety and efficacy, demonstrated in the LIVE-AIR trial, with results published in the Lancet and Thorax peer-review journals. And did the FBI challenge the trial design of the government-sponsored ACTIV-5 trial, excluding patients who showed the most benefit from their trial, and including patients who exceeded disease severity levels established by the company?

Additional questions should be asked about collusion between competitive pharmaceutical companies and government agencies who are largely funded by these commercial entities.

The FBI can't just act on boiler-plate language about FDA concerns, especially when ultimately, the FDA doesn't even Deny the EUA.

The FDA declined to Deny our EUA.

That's true, but it's a terrible way to express the outcome of the FDA's regulatory action. During the pandemic, the FDA granted themselves the ability to establish a third regulatory outcome, a Decline, to add to the binary outcomes of Deny or Approve. So my first sentence conflates two different outcomes. And that's exactly what the SEC did in their Indictment.

I'm now seeing that our prospective partners are commencing relatively small Phase III trials. I'm assuming this is just to confirm the data collected from the IND use of lenz in the Covid Influenza Combination (CIC) product.

see slide 21, for example
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465925002863/tm253091d1_8k.htm

Novavax AND Sanofi (and HGEN?) are waiting to conclude the Phase I and II studies, and then nail down our Approval with a BLA submission. That could be in days, weeks, or a month, or so. And that Approval doesn't have to come from the FDA. Besides, in a perfect world, several US government agencies will be too busy defending themselves against criminal charges, than to try to continue this charade against Humanigen. Just my opinion, of course.

In a more perfect world, your diatribe would make sense.
The world is very far from perfect, and in all reality lenz is doing nothing to save lives at the moment.
Im certain both dale  and cam have their collective traps shut per attorney orders . We will never hear from them until they get their cases settled. That will be year(s) from now

It's reasonable to think as you do, dlog.

But our success is going to have an EXPLOSIVE impact on the market. Major pharmaceutical companies will be absolutely devastated, as the triumvirate of Humanigen/Novavax/Sanofi will immediately have the covid market almost exclusively to themselves. Existing EUA's will be rescinded immediately.

And that will just be the beginning, as we're already starting to see in our targeting of other indications, such as flu, myeloid-driven cancers, aGvHD, etc.

If we are using the lenz IND authorization to effectively conduct Phase IV type trials, we wouldn't see that on the clinical trials website.

I dont agree anyone is currently doing anything with lenzilumab. If it were true it could be found somewhere other than your imagination 

Anybody get paid?

https://www.law.com/njlawjournal/2024/09/16/drugmaker-accused-of-overhyping-proposed-covid-treatment-agrees-to-3m-settlement/?slreturn=20250112105022

"Plaintiffs assert that lenzilumab's prospects of success were overstated, that defendants failed to disclose material adverse nonpublic information concerning the scientific merits of repurposing lenzilumab as a COVID treatment as part of a scheme to mislead investors into purchasing shares of Humanigen stock," Martini said.


According to Peironi's complaint, Humanigen is a clinical-stage drug development company focused on preventing and treating an immune hyper-response called a "cytokine storm. " The company's lead product was lenzilumab, a proprietary antibody, which was under development as a treatment for COVID-19, among other things.

"The complaint said that the stock price plummeted nearly 50% on the news that the Food and Drug Administration rejected Humanigen's emergency use authorization application. After the results of a clinical trial were published, which failed to show lenzilumab was effective against COVID-19, the stock price dropped again, nearly 80%, according to the opinion."

No, Humanigen DID NOT announce that, "...the FDA had declined EUA approval..." as stated in the DOJ's Second Indictment.

end of 3rd paragraph
https://www.justice.gov/opa/pr/chief-science-officer-publicly-traded-health-care-company-charged-insider-trading-scheme

Rather, Humanigen announced that the, "FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request."

https://ir.humanigen.com/English/news/news-details/2021/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients/default.aspx

The DOJ's intentional mischaracterization inaccurately infers that the FDA had made a decision on the company's EUA request. That would constitute material non-public information, which insiders are charged with having ahead of transferring or selling shares.

Quite the opposite is true. The FDA Declined to make a decision on our EUA. The FDA did nothing.

The DOJ notes alleged negative or cautionary feedback to management from the FDA.

The DOJ does NOT acknowledge the FACT that the FDA granted IND Authorization for lenzilumab in April 2020, which remains in effect, and has likely significantly enhanced covid and cancer products from several pharmaceutical companies.

Humanigen's management would know about the benefit lenzilumab is having in instances where it is being used under the FDA 's IND Authorization, if it is. Humanigen's management would also know that the FDA is aware of the full benefits lenz is providing under their IND Authorization, and that they should have approved our EUA.

I agree that world governments need some sort of gimmick to promote the well being of the populace. , im seeing entire circulatory systems dissected out of peeps completely encased in the spike protein goo from the mrna vaccines, its almost as bizzare as tinseltown burning to the ground just before cash takes office

We've got the 6th largest pharmaceutical company doing Phase I and II studies for us now, in my opinion. I think the heavy lifting is already about to wrap up, with the approval of lenz from the LIVE-AIR trial, or via a Phase IV trial in the form of the IND use of lenzilumab.

We need to establish an armamentarium of lenzilumab for our national defense. We are 100% unprepared for the holy hell we could be facing at any time. After the way the US government has treated Humanigen, they might have to force the production and procurement of lenz by some type of defense procurement orders.

Is there any way we can get lenzilumab to cause bloating, flatulence, fever, headaches, menstrual cramps, tingling, nausea, dizziness, fainting, so that it might be more palatable to big pharmaceutical companies ?

Stockholm Syndrome is the only explanation I can think of for why there is a preponderance to disbelieve that your government is not acting in your best interest, and may actually be orchestrating your demise. The safety of lenzilumab has never been questioned. And it is more reasonable to consider the suitability of Leavenworth for the federal employees involved in the corruption here, than it is to consider Danbury's suitability for management.

Jay the FDA doesn't pike drugs that dont have side effects, and neither does pharma . 
Can cam and dale run humanigen from danbury Connecticut 

Thank you, Private Messager, I will do as you suggested. By the way, I saw an error in my post, which I corrected and resubmitted. It is now post # 43649. It's reprehensible that the SEC would bring charges for stock transactions allegedly made ahead of a negative FDA decision, and no such decision is subsequently made by the FDA. The charges, likely instigated by the FDA, should be dropped.

Vigilant Fox,

The FDA granted IND (corrected) authorization to treat covid for Humanigen's Lenzilumab on April 2, 2020, just weeks after the pandemic started. So by May of 2021, it is likely they had full knowledge of the outstanding safety and efficacy lenz demonstrated under this IND authorization.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

Management communicated with the FDA during this year-long process, and the FDA knew the company was prepared to request an EUA based on their LIVE-AIR Phase III trial to treat hospitalized and hypoxic patients with covid pneumonia.

What did the FDA do? On May 25, 2021, "...The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:...As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the agency’s guidance, “Emergency Use Authorization Vaccines to Prevent COVID-19.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-25-2021

Three days later, May 28, 2021, "Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19." The FDA Declined to make a decision on our EUA application, based on their newly self-granted power to Decline to make a decision.

https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx

Lenz has the ability to program an appropriate immune response, which is also variant-agnostic. This poses a threat to a multi-billion dollar annuity revenue stream Big Pharma, who are major providers of government agencies' operating budgets, and grantors of royalties to government agencies' scientists, all currently enjoy.

3m
Replying to
@_flyers77

@VigilantFox
and 3 others
As we see, the FDA did not deny our EUA. They made NO decision. So what crime did mgmt commit by selling shares and equity financing operations after the success of the LIVE-AIR trial was announced? Granting themselves the power to Decline clearly signals they weren't gonna deny.

Now, exactly one year since filing bankruptcy, here we are with Humanigen's management faced with fresh charges, just filed on December 30th, 2024, which read as follows.

"According to the SEC’s complaint, between June and August 2021, Chappell and Durrant sold Humanigen stock while in possession of material nonpublic information that the U.S. Food and Drug Administration was unlikely to approve Emergency Use Authorization (EUA) for Humanigen’s newly developed COVID-19 drug, lenzilumab."

https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26206

But the crime wasn't that management sold stock and engaged in equity financing. They had just released their Phase III LIVE-AIR trial results, as I outlined in my previous post, demonstrating a 54% survival benefit OVER THE STANDARD OF CARE in place at the testing sites.

Rather, the crime was that, "...the U.S. Food and Drug Administration was unlikely to approve Emergency Use Authorization (EUA)," which proved prescient, because the FDA Declined to make a regulatory decision on our EUA.

Continuing since the pandemic are a significant number of covid-related excess deaths. Lenzilumab's ability to reduce the number of covid-related excess deaths needs to be factored into the FDA's determination of a cost/benefit ratio.

Covid reportedly hit America's shores in March 2020, with devastating results from this novel coronavirus. Doctors including Humanigen's management, and clinical trial investigators from Mayo Clinic, who were working with Humanigen evaluating lenzilumab as a cancer therapeutic, quickly recognized the pathogenicity similarities between cancer and covid, and sought FDA permission to use lenz to treat covid patients. The FDA acted quickly to grant this approval.

"Burlingame, CA, April 2, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage
biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the
company’s proprietary Humaneered® anti-human GM-CSF monoclonal antibody, announced that FDA has
approved the administration of lenzilumab for COVID-19 patients under individual patient emergency IND
applications to patients under the company’s compassionate use program.

The company is advancing plans to conduct a multicenter, Phase III, randomized, double-blinded, controlled,
clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with
pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19 patients."

https://s28.q4cdn.com/539885110/files/doc_news/archive/42e41d3f-b99b-4214-9d90-b917f07b32ae.pdf

An interim analysis of the ensuing Phase III LIVE-AIR trial was performed.

"Burlingame, CA – September 14, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage
biopharmaceutical company focused on preventing and treating an immune hyper-response called
‘cytokine storm’ with its lead drug candidate lenzilumab, today announced its Phase 3 registration trial of
lenzilumab in patients with COVID-19 was unanimously recommended for continuation without
modification by an independent DSMB after a planned interim analysis."

https://s28.q4cdn.com/539885110/files/doc_news/archive/78271d32-57a3-4cd5-943d-e6c52dde8999.pdf

This was followed in November 2020 with the announcement that the Department of Defense had entered into an agreement to help develop lenzilumab for Covid-19.

https://s28.q4cdn.com/539885110/files/doc_news/archive/04aeb1ee-cb62-474a-b1c6-ea29e3b7662e.pdf

Within a year of Humanigen launching this effort to treat covid, they announced favorable topline data.

"Humanigen Reports Positive Phase 3 Topline Results
Demonstrating That Lenzilumab™ Improves Survival
Without Need for Mechanical Ventilation in
Hospitalized Patients With COVID-19
3/29/2021"

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Reports-Positive-Phase-3-Topline-Results-Demonstrating-That-Lenzilumab-Improves-Survival-Without-Need-for-Mechanical-Ventila-O9C2T.pdf

The trial results were published in May 2021, and additional positive developments carried on for the remainder of 2021, to include a Lancet peer review. A subsequent peer review was published in Thorax in July 2022, and revealed that the "...likelihood of survival without mechanical ventilation (SWOV) was achieved in 90% of LIVE-AIR patients treated with lenzilumab plus standard of care compared to 79% treated with placebo plus standard
of care, which was highly statistically significant (HR 2.54, p=0.0009)."

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Announces-Peer-Reviewed-Publication-in-Thorax-Supporting-Early-Treatment-of-Hospitalized-COVID-19-Patients-with-Lenzilumab--LU1CP.pdf

As I recall, Humanigen changed the primary endpoint of the LIVE-AIR trial, to align with the primary endpoint of the designed-to-fail government-sponsored ACTIV-5 trial. Humanigen also accounted for the reasons there was a modified intent-to-treat population, with the main reason being that there was a shortfall of oxygen in Brazilian hospitals. I also don't think a p value of 0.0009 indicates a trial population that is too small.

In short, the FDA has kept lenzilumab's IND authorization in place since it was awarded in April 2020. That will soon be five years of clinical data, likely supplemented with Novavax's use of the lenz IND authorization to enhance their covid vaccine, which Sanofi plans to use with their Covid Influenza Combination vaccine.

It's the successful LIVE-AIR trial, with the Lancet and Thorax peer reviews, along with the IND use of lenz by Humanigen and several partners, that inform management of the safety and efficacy of lenzilumab. The informed feedback should have served as the basis for the FDA's Authorization and Approval of lenz, This lack of justification for the FDA depriving lenzilumab of an EUA was further evidenced by the FDA Declining to make a decision on our EUA.

I can see why the Indictment was sealed. It was not very impressive work, in my opinion. That applies to the factual basis, but perhaps more importantly, it applies to glaring omissions, also. How the heck did Dale lose the Appeal, if he did, if this is all the DOJ has?

I need to push through the analysis paralysis, my unwelcomed nemesis that consumes my day doing research, and culminates with me being so overwhelmed that I don't know where to begin.

It's just so incredulous to me that the FDA can reveal their confidence in lenzilumab by granting it IND authorization within weeks of the covid pandemic, and further evidenced by their continued confidence in lenzilumab, even now, by granting Sanofi Fast Track designation for their lenz-enhanced vaccines produced with Novavax, but yet the FDA refuses to grant Humanigen's EUA for lenz.

There are no excuses for this. They justify this negligence with two claims, a lack of demonstrated efficacy in the ACTIV-5 government-sponsored trial, as well as a lack of data sufficient to determine a risk/benefit conclusion. There is no merit to either claim, as has been clearly demonstrated, and substantiated by the Fast Track approval.

The FDA owes Humanigen a regulatory decision on the EUA, which they have never provided.

Jay Booth 1.4.25
@booth37337
·
2m
The $38M figure stuck in my mind, too. But the 'sells' were $68M, if they really were sells, and not shares transferred from a consolidation or merger, IAW the amended Asset Purchase Agreement.

https://sec.gov/enforcement-litigation/litigation-releases/lr-26206

https://x.com/search?q=humanigen&src=typed_query

I'm not talking about this message board. I'm talking this stock quote board:

https://ih.advfn.com/stock-market/NASDAQ/humanigen-HGEN/stock-price

I guess it's possible that we are maintaining a corporate headquarters in the US.

I think the IHUB message board is based on Humanigen stock since the company that stock represents has been dissolved, it has the FKA designation. 

The important thing is that Humanigen's bankruptcy judge did not ignore Humanigen Australia. It is THE key entity making the amended Asset Purchase Agreement, which he approved, viable.

I do have to wonder, though, how Ihub's stock quote board can still reflect that Humanigen is an American company. Always something to learn here.

The company has been restructured in such a way as to be largely unencumbered by the continued criminal abuse of discretionary authority by American government agencies. Humanigen investors and lenzilumab patients are positioned to lead wealthy and healthy lives. We have management to thank for that.

DURRANT will be indicted after DALE cutts a plea deal and rolls on him. As I wrote previously, this could take a year to 18 months before we see the DURRANT indictment, butt it is coming.

LOL@ this scam still NOTT trading!

This turd was nuffin butt garbage since the KBIO ticker. HGEN was designed as a pennyscam rig job. Now several of the scammers will get to spend some quiet, penitent time in Unkle Sammy's camps. It would be wonderful IF these crimes somehow link back to SHKRELI, as he needs a return visit to DaHole. His first sentence term was way too short. SHKRELI might be a stretch, butt one can hope!

This civil and criminole prosecution will play ~OUTT over years, so find a comfy seat and stock up on popcorn and iced tea. Now there is finally some real subject matter to post about on this bored. Nott just Jay's wackyass delusions and hallucinations. The PACER filings will make this bored worth reading.

The pieces just keep falling into place, DTG. I am super excited!

Happy New Year Jay! I more than anybody else on this board pray that somehow you end up being right about everything here!

I would love to see something come out restoring our shares.

"Many public health professionals are convinced that a new serious variant of the original COVID-19 source, will eventually emerge through mutation. By the end of 2023, a total of 772 million people worldwide had contracted COVID and its variants, and a new milestone was passed — 7 million fatalities worldwide (over 1.2 million in the US).

As of this writing (April 2023), people continue to die each day from COVID-19 and its mutations. Source: World Health Organization

Only disciplined application of monoclonal antibody therapies has kept these numbers from being much larger.

When — not if — a new outbreak occurs, Taran will be among the first with the experience and resources to begin addressing that need quickly."

http://www.pacificroyalties.com/resources/taran-therapeutics/

To me, the most significant unanswered question, for some time now, has been in regards to the covid pneumonia reinfection rate in lenz-treated patients. The only hint of the answer to my long-posed question comes from the quoted statement, to the effect that the number of people dying from covid and covid-related indications would be "much larger" were it not for lenz.

We know that lenz has been IND authorized to treat covid since the pandemic was less than one month old, in April 2020.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

I also believe that Novavax relied on lenzilumab's IND authorization to use Humanigen's patented lenz-vaccine cocktail to enhance their vaccine, for which they plan to submit a BLA application. We further know that Sanofi is using the Novavax vaccine for their Covid Influenza Combination (CIC) vaccine, which the FDA has Fast Tracked. Sanofi indicated the following about Novavax:

"First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections
•
Two phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by the combination vaccine candidates."

https://www.sec.gov/Archives/edgar/data/1121404/000119312524278124/d913939dex994.htm

Adding to the body of knowledge about lenzilumab's safety and efficacy are the Phase I and Phase II trials Humanigen has done for other indications, the PREACH-M and RATinG trials being done by our research partners, and the Investigator Initiated Trials by Mayo Clinic, and the fantastic results achieved by Gracell to enhance their CAR-T.

On April 2nd, we will have 5 years of clinical data obtained on lenzilumab's safety and efficacy, achieved under IND authorization. And again, the FDA has fast-tracked the Sanofi CIC candidate. And at some point while this massive amount of data has been accumulated, the FDA cites a lack of data to warrant an EUA?

I have not seen Novavax announce a clinical trial of their lenz-enhanced vaccine. Yet, they plan to submit a BLA application. I think this will effectively be akin to a Phase IV trial, as I discussed a couple of days ago.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175591794

Of course, management knows that covid deaths would have been much higher without the IND use of lenz, starting almost 5 years ago, and as further proven with our twice peer-reviewed LIVE-AIR trial results, showing a Hazard Ratio of 2.54, with a p value of 0.0009.

https://thorax.bmj.com/content/thoraxjnl/78/6/606.full.pdf

The ACTIV-5 government trial was designed to fail, excluding hospital scale 4 patients on room air, which was the majority of the LIVE-AIR patients. They also included more severely ill patients, even on mechanical ventilation.

When the FDA Declined to award us an EUA, using their newly self-granted power to refuse to make a regulatory decision, they effectively took lenz off the market, without denying our EUA, which they would have had to justify.

Faced this this blatant willful negligence, which would continue to allow preventable deaths, management decided to continue funding the company's operation by equity financing. And that's assuming that the number of shares alleged to have been sold, WERE actually sold. Again, with the design of the share structure, Black Horse shares marked as sold, may only have been transferred, such as to Humanigen Australia.

These government employees need to be held accountable, and prosecuted to the full extent of the law.

The SEC filed a Second Amended Complaint on December 30th, 2024, including Durrant.

https://www.sec.gov/enforcement-litigation/litigation-releases

On the other hand, as I pointed out previously, on December 11th, 2024, the FDA granted Fast Track designation for the lenz-enhanced (?) Novavax vaccine(s) that Sanofi plans to use.

https://www.sec.gov/Archives/edgar/data/1121404/000119312524278124/d913939dex994.htm

Many times over the years, I pointed out that the Form 4's for the insiders may inaccurately be viewed as 'sells,' when shares were merely transfers. In fact, this could be the mechanism by which Humanigen Australia acquired shares, if they have.

And then there were two. Taran Pharma voluntary dissolved.

https://find-and-update.company-information.service.gov.uk/company/09252520/filing-history