Humanigen Inc (HGENQ)

[Engineering_Simple]

Here's some of my DD on HGEN to help speed anyone up still looking to open a position:

(Just some context to get the gist of what you're getting into)

Background

- Based in South San Francisco
- <20 Employees
- Takeover by Martin Shrkeli (aka "Pharma Bro") Nov '15
- Filed Chapter 11 Dec '15
- Changed name from "KalioBios" to "Humanigen" shortly after
- Has never brought a product to market
- Lenzilumab has been the primary focus of the company for last 2yrs

Financials

-SEC Filing - HGEN - Quarterly Report (Form 10-Q) - https://www.sec.gov/Archives/edgar/data/1293310/000121465920004718/j5820210q.htm
-Liquidity & Going Concern (Excerpt from Quarterly Report)
"The Company has incurred significant losses since its inception in March 2000 and had an accumulated deficit of $287.4 million as of March 31, 2020. At March 31, 2020, the Company had a working capital deficit of $15.1 million. To date, none of the Company’s product candidates has been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses to continue for the foreseeable future. The Company will require additional financing in order to meet its anticipated cash flow needs, which are expected to increase as the Company’s clinical trial activities accelerate during the next twelve months. As a result, the Company will continue to require additional capital through equity offerings, debt financing and/or payments under new or existing licensing or collaboration agreements. If sufficient funds are not available on acceptable terms when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, could materially harm its business, financial condition and results of operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern."


Product

- Focused on developing medicine for patients with neglected & rare diseases.
- Lenzilumab
- A humanized monoclonal antibody that targets GM-CSF
Application:
- Immune response to infection releases cytokines into the bloodstream to fight the disease
- Some patients have a deranged response where excessive cytokines flood the bloodstream
- This cytokine causes a "storm" which causes severe inflammation, compounding existing respiratory complications.
- Lenzilumab blocks the cell communication for GM-CSF, reducing sensitivity of cytokine release, preventing "cytokine storm"
- Video Explanation

Leadership

Ugly history with Martin Shkreli... explained:
https://smithonstocks.com/kalobios-the-fascinating-story-of-the-takeover-of-the-company-by-martin-shkreli-and-hedge-fund-friends-kbio-18-25-i-would-not-touch-this-stock/

Chairman & CEO - Cameron Durrant, MD, MBA
-Serial biotech experience as Exec Chair, CEO, CFO
-Pharmacia, J+J, GSK, Merck
- Led previous deals with Gilead (HIV) while at J+J and also competed with Gilead (HCV)
- Small company experience in ped onc, onc

Chief Scientific Officer - Dale Chappell, MD, MBA
-Founder, Black Horse Capital Advisors. <-- HE FOUNDED THE INSTITUTIONAL INVESTMENT FIRM!!!! (See attachments for details)
-Decades of biotechnology investment experience
-HHMI Fellow, National Cancer Institute, Rosçnberg Lab
-Multiple publications in T-cell therapy, GM-CSF and immunology pathways
-Focused on developing medicine for patients with neglected & rare diseases.

Vice President PharmD - Omar Ahmed
-20-year pharmaceutical executive at Roche, Novartis, J&J
-Led multiple blockbuster launches setting a new SOC globally
-Led development of Janssen’s immunology portfolio strategy
-Deep expertise in I/O and biologics development
-Led collaborations with GSK, Merck, Astellas, Vertex, Idenix, and others

COVID-19 Action

-April 2 - Change in ownership (Back Horse/ Cheval Holdings)
-April 15 - HGEN presents Lenzilumab to FDA as candidate for covid19 treatment, obtains approval to proceed with Phase 3 human study Presentation
-May 6 - First patient dosed with Lenzilumab in FDA approved phase 3
Phase 3 Study to Evaluate Efficacy & Safety of Lenzilumab in Hospitalized Patients w/ COVID-19 Pneumonia FDA clinical trial record attached
-May 11 - CEO Cameron Durrant discusses trial with Proactive Investors, a news platform for pharma companies seeking investments (Not a media company!)

IMPORTANT COMMENT!!!!... at 1:38 of the interview he says there will be an interim analysis halfway through the study (May 20 is halfway for 1st patient)

-May 20 - CEO Cameron Durrant buys 250,000 shares of common stock ($215,000 investment) in HGEN... SEC filing attached
-May 20 - CSO Dale Chappell buys 26,847 shares of common stock ($23,088 investment) in HGEN... SEC filing attached
-May 21 - *Bought shares of common stock in HGEN @ 0.91*
-May 21 - Short interest drops from 2% --> 1% in HGEN
-May 26 - Price action shows strong resistance at $0.95 ... someone is actively preventing the stock from rising above this point.
-May 26 - *Bought shares of common stock in HGEN @ .9025*
-May 27 - Humanigen announces contract manufacturing with Ajinomoto Bio-Pharma to fulfill production of Lenzilumab in San Diego, California
-May 27 - *Bought shares of common stock in HGEN @ 0.89*
-May 28 - Large investor bought 28,000 shares of HGEN stock @ .90 (0.05 higher than daily 0.85 price average)
-May 28 - *Bought shares of common stock in HGEN @ 0.90*
-May 28 - Short interest drops from 1% --> 0.7% in HGEN
-May 29 - Apparent that HGEN has attracted attention from large investors, price breaks through 0.95 ceiling
...
-Jun 3 - Anticipated trial completion for 1st patient from May 6th


... Now I obviously haven't added any updates on activity or findings since June 1st, but if you're reading this i'm sure you're already up to speed on what's happened this last week :)

Good luck everyone!