The company is trying to find a potential path forward in COVID-19 for the drug and is in talks with platform study groups after a Phase III study did not show statistical significance, but still showed activity.They looked promising, but somehow it didn’t work out too plan. The share price has fallen close to 99 percent in the last year. At one point dipping down to 13 cents us per share. It has burned trough large amount of money, but hasn’t achieved the breakthrough is was looking for . Not yet. So what is the plan forward ? They have engaged SC&H Capital, an affiliate of SC&H Group, to advise Humanigen on exploration of strategic options. SC&H is an investment banking and advisory firm providing merger and acquisition (M&A), financial restructuring and related business advisory solutions to emerging and growing companies. They promote themselves as being able to get results in restructuring businesses in as little as 60 days. Humanigen is set to release it’s earnings report on the 17th of November. That could give us some hints for where they are heading.
They have announced a strategic realignment of its pipeline and resources to achieve key clinical milestones. The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia.This is a very rare blood cancer, for which the PREACH-M study is already underway. Humanigen will also advance its plan to study lenzilumab in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, which will be the focus of the RATinG study that is expected to enroll its first patient this year. These studies are majority funded by clinical partners of Humanigen.
They have significantly reducd its go-forward, cash-based operating expenses including elimination of ongoing lenzilumab manufacturing, significant reduction in other R&D costs, and reduction in general and administrative expenses through headcount reduction as well as other initiatives. They are now down to 11 employees.
Part of the strategic realignment plan according to Humanigen press release is as follows :
Advancing and expanding the ongoing PREACH-M study of lenzilumab for the treatment of high-risk chronic myelomonocytic leukemia (“CMML”) in patients with NRAS, KRAS, and CBL genetic mutations to more rapidly reach the initial clinical assessment of this open-label study once sufficient patients have received three cycles of treatment with lenzilumab in addition to azacitidine. Three patients have been enrolled in the study and followed for multiple cycles, all with encouraging results.
The current standard of care for CMML are hypomethylating agents such azacitidine and decitabine, which historically have a complete response rate of 11%-22% according to the International Working Group Criteria.1,2,3
Australian clinical partners plan to open additional sites in Australia and may also expand the study to centers in New Zealand.
Humanigen plans to support expansion of the study to U.S. sites and has received approval from the Principal Investigator to share the protocol and provide monitoring to those additional sites.
The incidence of CMML in the US, UK, and Australia is about 1,700 patients annually.4 As a rare disease, lenzilumab may qualify for certain regulatory and commercial advantages that may accelerate development and approval. Humanigen and the Principal Investigator are assessing regulatory pathways that may enable early results to support a regulatory submission and potential approval by the Therapeutic Goods Administration in Australia, which could be expanded through Project Orbis to the United States and the United Kingdom.
So with time running out . Reserves running low, but patents freed up with loans paid off we might have hit the bottom. Speculators and gamblers have started to pour money into buying shares at bargain prices. If Humanigen can pull something out of the hat, then the upside could be very profitable for the ones that just discovered the company. For most long-term investors the situation seems bleak at the moment. The research at one point seemed very positive for patients outcomes. Let’s hope Lenzilumab still can provide some future solutions. But right now it seems just like that. Hope, but not much else. At least whoever is buying up shares right now must have some strong believes and nerves of steel. Good luck to us all !