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….

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Out Of The Mists — For A Moment Only — To Mention A New Convert Financing: $1.3 Million….

Been a bit, but I appear, just to complete the record (and remember the first image, in August, seven years ago).

Here is a link to the full SEC Form 8-K, filed overnight — and a bit of it:

“…$1.3 million of loans made to the Company by an investor group led by Soundview Capital Partners LP.

The Notes bear interest at a rate of 7.5% per annum and will mature on the earliest of (i) twenty-four months from the date the Notes are signed (the “Stated Maturity Date”), (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company plans to use the proceeds from the Notes for working capital.

The Notes are convertible into equity securities in the Company in four different scenarios….”

See the full SEC Form 8-K, for those scenarios. Onward, and best of luck to Dr. Durant, and his entire team!

Early 2019: Good News Post Scriptum | Brain Cancer Pipeline Possibilities…

Yes… it is only in a mouse model study, but it is encouraging, as this fine new management team truly leaves Shkreli more and more as… some ancient (largely irrelevant) history.

Here’s the full release — I am a week late on it, but here you go:

“…The research, led by Professors Bryan Day and Andrew Boyd from the Department of Cell and Molecular Biology, QIMR Berghofer Medical Research Institute in Brisbane, Australia, used an anti-EphA3 antibody (IIIA4) which is the murine predecessor of the company’s Humaneered® ifabotuzumab. The research assessed the efficacy of the antibody drug conjugate (ADC) and a radioimmunotherapy (RIT) conjugate using orthotopic human GBM xenograft tumors in NOD/SCID mice. Positron emission tomography/computed tomography (PET/CT) imaging, showed that the anti-EphA3 antibody is effectively delivered across the blood-tumor barrier and accumulates specifically at the tumor site with no observed normal brain tissue uptake. Anti-tumor activity was observed in this immunocompromized mouse model, using an ADC comprising the cytotoxic drug maytansine or an RIT comprising the radioisotope Lutetium-177. Significant increases in overall survival (p=0.0007, n=6 for the ADC, p=0.0329, n=6 for the RIT) were observed for both types of conjugates.

Critically, the researchers showed previously that EphA3 is expressed most highly on glioma stem cells (GSCs), where EphA3 has a functional role in survival and self-renewal. In GBM, EphA3 expression has been shown to be significantly elevated in recurrent versus treatment-naïve disease. EphA3 has also been shown to be over-expressed in a number of human solid tumors. EphA3 antibody targeting has been shown to inhibit tumor growth by disrupting newly formed tumor microvasculature (neovasculature).

Brain cancer sufferers have not seen meaningful increases in overall survival for decades,” stated Dr. Cameron Durrant, Chief Executive Officer of Humanigen. “By targeting the tumor stem cells, stromal cells and neovasculature, we believe ifabotuzumab has the potential to emerge as a next-generation oncology therapy.” A phase 1 clinical trial is currently underway using ifabotuzumab, the Humaneered® version of the anti-EphA3 targeting monoclonal antibody that was used in this study, in patients with recurrent GBM. This study is in part motivated by reports of the positive results of other ADC therapies in the treatment of GBM. An ADC which is in Phase 3 for GBM is in development by Abbvie and utilizes the cytotoxic agent monomethyl auristatin F (MMAF) combined with depatuxizumab. Efficacy has been demonstrated as both a single agent and in combination with temozolomide (TMZ). “Ifabotuzumab is being developed by the leading experts in the space, who played a critical role in the discovery and development of depatuxizumab,” continued Dr. Durrant….”

Onward. Now you know.

I Think That’s… A Wrap.

The person whose crime-spree (entirely unrelated to any ongoing operation of this now reorganized independent public company) animated this site about three years ago… has now faded… into irrelevance — both out there, in the life sciences world, and in his own personal sphere (as FCI Ft. Dix Inmate No. 87850-053 — Projected Release Date: November 2023).

So — barring something truly cataclysmic, this site is now… closed — as to original anonymous-blogger-created content.

Humanigen will be fine — and is a fine company — now that it is rid of him, and out of bankruptcy.

नमस्ते

New $2.5 Million Convertible Loan Financing Led By BlackHorse Capital: SEC Form 8-K

Here is the latest, filed overnight with the SEC — and this means the company has more post bankruptcy runway now. The notes get prepayment preference if the company cannot raise at least $10 million in a next round financing:

“…Commencing September 19, 2018, Humanigen, Inc. (the “Company”) delivered a series of convertible promissory notes (the “Notes”) evidencing an aggregate of $2.5 million of loans made to the Company by six different lenders, including an affiliate of Black Horse Capital, L.P., the Company’s controlling stockholder.

The Notes bear interest at a rate of 7% per annum and will mature on the earliest of (i) twenty-four months from the date the Notes are signed, (ii) the occurrence of any customary event of default, or (iii) the certain liquidation events including any dissolution or winding up of the Company or merger or sale by the Company of all or substantially all of its assets (in any case, a “Liquidation Event”). The Company plans to use the proceeds from the Notes for working capital.

The Notes are convertible into equity securities in the Company in three different scenarios:

If the Company sells its equity securities on or before the date of repayment of the Notes in any financing transaction that results in gross proceeds to the Company of at least $10 million (a “Qualified Financing”), the Notes will be converted into either (i) such equity securities as the noteholder would acquire if the principal and accrued but unpaid interest thereon (the “Conversion Amount”) were invested directly in the financing on the same terms and conditions as given to the financing investors in the Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes).

If the Company sells its equity securities on or before the date of repayment of the Notes in any financing transaction that results in gross proceeds to the Company of less than $10 million (a “Non-Qualified Financing”), the noteholders may convert their remaining Notes into either (i) such equity securities as the noteholder would acquire if the Conversion Amount were invested directly in the financing on the same terms and conditions as given to the financing investors in the Non-Qualified Financing, or (ii) common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes).

The Notes may convert in the event the Company enters into or publicly announces its intention to consummate a Liquidation Event. Immediately prior to the completion of any such Liquidation Event, in lieu of receiving payment in cash, noteholders may convert the Conversion Amount into common stock at a conversion price equal to $0.45 per share (subject to ratable adjustment for any stock split, stock dividend, stock combination or other recapitalization occurring subsequent to the date of the Notes)….”

Now you now. I expect that any day now, we will have an order finally closing the Chapter 11.

[U] New Pitch Deck; And Motion To Close Out Ch. 11 Bankruptcy Proceedings

UPDATED: 7 PM EDT — We now learn via a late in the day filing in Delaware, that almost $5.8 million in legal fees were spent on the bankruptcy (before counting the perhaps additional $4 million various investors spent chasing Marty — all over the nation), ALL directly due to Marty’s fraud schemes. Disgusting. Not Humanigen’s fault — Marty’s. UGLY. But nearly $10 Million of completely unneeded cash expense burn, had there been an honest (even if mistaken) control group in late 2015. End updated portion.

Both of these are stale pieces of news, now — as I have been busy in other parts of my digital life. [And thankfully, this may be about the end of this particular blog’s run.]

But now approaching exactly three years after Martin Shkreli fraudulently seized control of this company, then known by a different name, it has filed a motion to emerge from bankruptcy protection — and close the federal case in Delaware.

And of more forward looking importance, here is the newly revised investor pitch deck (highlighting R&D efforts aimed at oncology related uses of T-Cell enhancers) — a presentation for road shows.

As I likely vanish into Brigadoon like mists, I’ll note a cleverly snarky meme — putting Marty’s face behind the Nike / Colin Kaepernick copy now appears — suggesting he risked “everything” — for a sample of HRC’s hair.

That is decidedly funny — but more soberly, it does a disservice to the able, ethical and (prudent) risk-taking people who kept the lights on here, after his felony securities fraud crime spree decimated the prior innocent public equity securities investors. Kudos to them.

Namaste.

Humanigen’s Q2 2018 SEC Form 10-Q Is On File…

…and here is where the matter with Savant stands (see page 16 of that link):

“…On August 1, 2017, the Company moved to remand the case back to the Delaware Court (the “Motion to Remand”).

On August 2, 2017, Savant sent a foreclosure notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the “TRO”) and Preliminary Injunction in the Bankruptcy Court on August 4, 2017. Savant responded on August 7, 2017. On August 7, 2017, the Bankruptcy Court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies under the MDC Agreement or the Security Agreement. The parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court.

On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO, ordering that any request to dissolve the TRO be made to the Delaware Court.

On February 13, 2018 Savant made a letter request to the Delaware Superior Court to dissolve the TRO. Also on February 13, 2018, Humanigen filed its Answer and Affirmative defenses to Savant’s Counterclaims.
On February 15, 2018 Humanigen filed a letter opposition to Savant’s request to dissolve the TRO and requesting a status conference. A hearing on Savant’s request to dissolve the TRO was held before the Delaware Superior Court on March 19, 2018. The Delaware Superior Court denied Savant’s request to dissolve the TRO and the TRO remains in effect.

On April 11, 2018, Humanigen advised the Delaware Superior Court that it would meet and confer with Savant regarding a proposed case management order and date for trial. On April 26, 2018 the Delaware Superior Court so-ordered a proposed case management order submitted by the Company and Savant.

There have been no further proceedings in this matter to date….”

Now you know. Go read the whole filing for an overall sense of where the business stands.