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price can be received until the Offering Statement is filed with the SEC and qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date of the Offering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….

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.