If You Are Looking To Keep Track Of What Happens To Martin Shkreli… Link Below.

This old and long-archived site has been getting lots of traffic from New York, and Brooklyn, particularly.

I suspect many are looking to catch up on what has become of the felon Martin Shkreli, still incarcerated in a federal low-security facility in rural western Pennsylvania.

He was, of course — for about 10 weeks, over five years ago now, in control of what later became (by a series of name changes, and a reorganization in bankruptcy) this much better public company.

So — I honestly don’t know why you’d want to — but if you do want to know what is the current state of all the litigation swirling around Martin, you may click here. It is up to the minute, on all topics, from Phoenixus AG to Vyera to Martin’s deepening woes.

The sole exception (generally speaking) is his personal life; I tend to avoid any mention of that… as. I don’t. care.

Onward, and be excellent to one another. Out.

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Proving That Unbridled Greed Isn’t Needed — To Succeed, In REAL Life Sciences Efforts…

We are grinning, ear to ear, here. Kudos to the reborn Humanigen executive and science team! Up over 90% on the NASDAQ this morning! Woot!

The back-story, then: When, in December 2016 — after Martin Shkreli manipulated the old KaloBios stock, wildly — and he was arrested, this company was forced into a nearly immediate bankruptcy reorganization (December 31, 2016). It ultimately changed its name (September 2018), attracted a new and highly-capable executive team, secured debtor in possession financing, and switched its focus to new and novel therapeutic programs, as opposed to the orphan disease price-gouging ideas Martin had suggested — but never executed (due to his arrest and convictions).

Now that far more noble effort has paid off — big time.

Of course, these are top line results, but given an n of over 500 patients, the results are pretty much conclusive: Lenz- helps severely ill COVID-19 patients avoid ventilators, and recover more quickly, and completely. There was a 54% reduced risk of having to be put on a ventilator, if Lenz- was used as a therapeutic against the so-called “cytokine storm”.

So the NASDAQ specialist firms have the reborn company trading completely through the roof this morning, up over 96 45per cent from Friday’s close.

Congrats, Dr. Durrant and team — you’ve proven that unbridled greed is not the only way to approach life science. And the Universe has rewarded that morality, very handsomely. This team was patient, stayed focused, didn’t overspend — kept several candidates progressing apace, all by not unduly seeking immediate cash salaries and bonuses. Kudos!

I will also cross post this on the now-archived KaloBios / Humanigen blog.

I am grinning ear to ear, as well — because I’ve beaten Mr. Obama’s brackets by a minimum of three games, and he can only win one more game that I won’t win, as well. Still, Sister Jean and the boys from Loyola are out… but well-played, Mr. President — well played!

Namaste….

Dr. Durrant Was On Tucker Carlson’s Odious Fox Show, Tonight — Sandwiched Between Lunatic Segments…

But I watched it all, and felt he handled the short interview quite well.

Afterall, he was dumbing it down — for the relatively “science impaired” Tucker, and his audience — whom, reliable research indicates, tend to be less educated than the average American, by over four years. [Proportionately more of Carlson’s audience never went to college, than any other nightly information program’s average audience, per 2017 Nielsen demographics.]

So, Cameron spoke in very easy (if overly simple) metaphors. But he clearly conveyed the sense that lenz- is showing remarkable (if preliminary) results, in up to 80 per cent of hospitalized cases — at ending the cytokine storm.

That in turn reduces lung inflammation, and that in turn improves… breathing.

Which — in many cases, allows the COVID-19 patient to leave the hospital altogether.

So — given that his slot was between pre-booked Carlson “village idiot” guests… he did quite well.

Quite well, indeed.

More Positives, For Humanigen’s Lenz-Program: Now In Study With Gilead’s Leading Remdesivir, On Covid-19 Therapies…

Again, the study is just getting underway, but this is a very important validation — that Gilead, and its admittedly leading Remdesivir program for COVID-19 therapies… is being jointly trialed with Humanigen’s Lenz-… it must be very gratifying for Dr. Durrant and his team.

One bad result, and the whole circus will have to fold its tents, and hop a train out of town — but for now, they are playing… Madison Square Garden. And the shows are… sold out.

In truth, quite a nice karmic turnaround, from Martin Shkreli’s long-ago debauchery (of its former entity’s life science programs, on unrelated agents). Here’s the bit, tonight:

“…Humanigen… trading for 46 cents per share as recently as mid-March, announced Monday afternoon that its lenzilumab will be tested in combination with remdesivir in NIAID’s Big Effect Trial, effectively categorizing it as a high-priority Covid-19 therapeutic candidate….”

Some times, the good guys do indeed win out — eventually. And this may be one of those stories.

Do stay tuned.

Onward.

June 2020: Humanigen Brings In $72 Million In A Private Placement — And Has More (Smallish) Nice Lenz- Results… At ~$5.30/Share…

And that’s up from $0.34/share as recently as December of 2019…

So — still early, and only 12 very ill patients seen, but they all made remarkable improvements.

Here’s the early June 2020 JP Morgan capital raise — giving them quite a bit of new runway.

Perhaps childishly, I am smiling, because… it will really bug old Martin Shkreli that this company actually now has a real drug — to be sensibly priced, of course — and a real on-ramp to big returns — all while saving human lives (doing well, by doing… good), in otherwise desperate situations.

And… the shares are now well above the level at which the bankruptcy court forced Martin to sell his stake.

That’s what hurts him… the most.

Congrats, to Dr. Durrant and his fine team!

Onward, grinning….

Friday — Smiling — UPDATE: FDA “Compassionate Use” Authorization Now Granted…

Do See this press release, as of April 2, 2020.

Well… that was quick.

Gratifying, too… see this:

…Ultra-thinly traded micro cap Humanigen (OTCQB:HGEN +156%) rockets up on a 16x surge in volume, a scant 67K shares, in response to its proposed plan to conduct a Phase 3 clinical trial evaluating lead drug lenzilumab for the prevention and treatment of cytokine storm (potentially life-threatening out-of-control immune response) that could lead to acute respiratory distress syndrome associated with SARS-CoV-2 infection, the coronavirus responsible for the COVID-19 outbreak….

Lenzilumab is a monoclonal antibody that neutralizes (binds to) a pro-inflammatory protein called granulocyte-macrophage colony stimulating factor (GM-CSF) that is over-expressed in COVID-19 patients. The company is developing it for the potential treatment of CART-T toxicity, graft versus host disease, certain blood cancers and eosinophilic asthma….

Yep — it may all not ultimately pan out, but I am grinning, this afternoon. Onward.

नमस्ते

From Our Other Properties…

Here it is — yet another post scriptum:

In 2016, Dr. Cameron Durrant [As The Polar Opposite Of Martin] Took Over At KaloBios — Now Called Humanigen…

…And Dr. Durrant may well (if rather suddenly) have on his deft hands… a viable COVID-19 “radical intervention” treatment candidate — for the wracking lung destruction the most severe form of the viral infection occassionally inflicts.

[What a sweet irony it would work, should all of this play out in the favor of those investors burned by Martin, since long ago he was required to divest all his holdings in what became Humanigen. But back to the story, proper, then:]

One of the programs Dr. Durrant has pursued since the company was freed of Martin via a bankruptcy reorganization, involved… Lenzilumab.

Here is a bit from the top of page 78 of the just filed Humanigen SEC Form 10-K, related to the at least animal model studies of Lenzilumab:

“…Recent data from China and the subject of a pre-publication titled “Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus”, supports the hypothesis that cytokine storm-induced immune mechanisms have contributed to patient mortality with the current pandemic strain of coronavirus.

The severe clinical features associated with some COVID-19 infections result from an inflammation-induced lung injury requiring Intensive Care Unit (ICU) care and mechanical ventilation. This lung injury is a result of a cytokine storm resulting from a hyper-reactive immune response. The lung injury that leads to death is not directly related to the virus, but appears to be a result of a hyper-reactive immune response to the virus triggering a cytokine storm that can continue even after viral titers begin to fall.

The authors of the study assessed samples from patients with severe pneumonia resulting from COVID-19 infection to identify whether inflammatory factors such as GM-CSF, G-CSF, IL-6, MCP-1, MIP 1 alpha, IFN-gamma and TNF-alpha were implicated.

The authors noted that steroid treatment in such cases has been disappointing in terms of outcome, but suggested that a monoclonal antibody that targets GM-CSF may prevent or curb the hyper-active immune response caused by COVID-19 in this setting. Humanigen believes that the authors’ findings are worthy of further investigation, suggesting that to reduce or eradicate ICU care and prevent deaths from COVID-19 infection, an intervention may be needed to prevent cytokine storm.

Separate publications confirm that cytokine storm is characterized by surge of high levels of circulating inflammatory cytokines, and is an overreaction of the immune system under the conditions, such as CAR-T therapy and patients infected with SARS-CoV-2. These recent studies revealed that high levels of GM-CSF, along with a few other cytokines, are critically associated with severe clinical complications in COVID-19 patients. High concentration of GM-CSF was found in the plasma of severe and critically ill patients, which account for approximately 20% of all patients, especially in those requiring intensive care.

Lenzilumab has been shown to prevent cytokine storm in animal models and this work has been published in peer reviewed journals. Patients are expected to be enrolled soon in a clinical study to determine lenzilumab’s effect on cytokine storm associated with the hyper-active immune response associated with CAR-T therapy, in collaboration with Kite Pharma….”

Clearly, these are only early green shoots — but promising, just the same.

And no matter how the Lenz- program turns out, I am abidingly convinced Martin didn’t really spend his talent very wisely, or well — in the first half of his life.

Even so, I’ll remain hopeful that was “the life he learned with“… and, now [starting in 2024] — perhaps he may yet do something wonderful with the “life after” — his now hard-learned BoP lessons…. just maybe.

Onward — smiling. Ever… smiling.

Post Scriptum: Huzzah! Ronald Informs Us… Daraprim Is Now FDA Approved As A Generic; Cerovene To Begin Sales IMMEDIATELY…

Well, this is great news for toxoplasmosis sufferers.

And it likely is the end of Phoenixus’ minimally remainining business model, in the US.

As commenter “Ron” so helpfully alerts us, over on the Shkreli site — the US FDA just approved the first generic version of… Daraprim. It will be sold by a company out of India, called Cerovene. I post here, since Martin had from time to time, with different investors, suggested Daroprim might become a pre-reorganization KaloBios asset. What a tangled web he wove….

Now about four years later — time to buckle up, Martin — whatever Turing / Vyera / Phoenixus private company shares you are still holding…

They just became… so much birdcage / wastebin lining material.

Grin. Not entirely, in truth — but it is nice… karma, for Martin, to be certain.

Onward.

Humanigen Exploring A Reg. A+ Rights Offering — Just Testing The Waters. No Indicated Terms Yet.

On the heels of extending the maturity date of the company’s bridge loans to year end 2019, the company is now testing the waters for a Reg. A+ short form registered offering of shares, via a rights package to existing holders, at a price as yet undetermined. Specifically, the company says it is “contemplating conducting a broadly syndicated rights offering…[precise terms TBD].”

The presser is here; and that prior link above is the maturity extender, filed with the SEC on October 8.

“…Humanigen plans to “test the waters” to gauge market demand for its proposed Regulation A+ rights offering prior to filing the Offering Statement with the SEC. No money or other consideration is being solicited at this time, and if sent in response, will not be accepted. No offer to buy the Shares or other securities can be accepted and no part of the purchase price can be received until the Offering Statement is filed with the SEC and qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date of the Offering Statement. Any person’s indication of interest regarding the Shares or this press release involves no obligation or commitment of any kind….”

Now you know. I foresee at least one more maturity extender, on the bridge, before this all gets placed.

Possibly out to February 2020. We shall see. [I had a spike in traffic this morning, here — and noticed that it is likely due to the above events being announced, but not yet SEC filed. That should come by an SEC Form 8-K — in two days. Onward.]

A Strong Science-Based Validation, Of The “New” Humanigen Team…

A very kind anonymous commenter pointed us to this Gilead / Kite / Stifel Nicolaus item.

I must say, this is precisely the sort of company one would hope to see people as fine as Dr. Durrant… keeping. [Long gone is the sordid past usurper.]

Here is the latest — in a continuing rebirth of a fine research based life science company:

…Kite, a Gilead Company (Nasdaq: GILD) and Humanigen, Inc., (HGEN) announced today the formation of a clinical collaboration to conduct a Phase 1/2 study of lenzilumab, an investigational anti-GM-CSF monoclonal antibody, with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The objective of this study is to determine the effect of lenzilumab on the safety of Yescarta. Kite will act as the sponsor of this study and will be responsible for its conduct.

GM-CSF has been identified, through clinical correlative analysis and preclinical modeling, as a potential key signal in the inflammatory cascade triggering toxicities associated with chimeric antigen receptor T (CAR T) cell therapy.1 Toxicities associated with CAR T therapy include neurologic toxicity and cytokine release syndrome (CRS). Emerging pre-clinical evidence suggests that lenzilumab inhibition of GM-CSF may have the potential to disrupt CAR T cell mediated inflammation without disrupting CAR T cell anti-tumor efficacy.

“CAR T therapy represents a significant advance in the way relapsed or refractory large B-cell lymphoma is treated,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “As leaders in cell therapy, we are committed to pursuing a number of clinical and preclinical strategies aimed at further improving the efficacy and safety of CAR T therapy. We look forward to this clinical collaboration with Humanigen and to evaluating the combination of lenzilumab and Yescarta in our clinical trial….”

“Humanigen has pioneered the approach to neutralizing GM-CSF to improve CAR T,” said Cameron Durrant, MD, Chief Executive Officer, Humanigen. “This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR T cell treatment outcomes….”

Stifel, Nicolaus & Company, Incorporated acted as exclusive financial advisor to Humanigen in this transaction….

[Long gone is the felon who shall not be named — thank the goddesses. It is so gratifying to see him flailing — mostly helplessly, from jail (filing loony-bin suits against the people… he stole from)… while this fine reborn company makes scientific strides, and perhaps… history.]

Mountain biking, by the lake — after hot coffee (cream and sugar, please!), OJ, a banana, and a bunch of bright Michigan cherries, now. Grin.

Namaste….