Humanigen, Inc. - HGEN STOCK NEWS

Humanigen, Inc. (Nasdaq: HGEN) announced a significant advancement in CAR-T therapies through a peer-reviewed publication in Leukemia. The study highlights the effectiveness of CRISPR/Cas9-mediated GM-CSF knock-out CAR-T cells, which exhibit reduced apoptosis and improved anti-tumor activity in vivo. With the upcoming Phase 3 SHIELD study aimed at assessing lenzilumab's role in preventing common toxicities associated with CAR-T therapies, this research underscores the potential to enhance treatment efficacy while minimizing adverse effects. Lenzilumab, a first-in-class monoclonal antibody, is critical in managing cytokine storms.

Humanigen (HGEN) announced significant findings from a peer-reviewed publication regarding lenzilumab's potential to save costs in treating COVID-19 patients. The study indicates that adding lenzilumab to standard care could save over £5.5 million weekly and provide per-patient savings between £8,462 and £17,277. With approximately 20,000 patients hospitalized in the UK, the need for effective treatments is evident. Lenzilumab also showed improved clinical outcomes in hospitalized patients, particularly in specific demographics, thereby increasing potential healthcare system efficiencies.

Humanigen, Inc. (Nasdaq: HGEN) reported a net loss of $236.6 million for 2021, up from $89.5 million in 2020, primarily due to $213.1 million in R&D expenses, including significant manufacturing costs for lenzilumab, which aims to treat COVID-19 and other conditions. The company completed its LIVE-AIR study, demonstrating a 54% improved likelihood of survival without invasive ventilation for COVID-19 patients treated with lenzilumab. With key studies ongoing, Humanigen anticipates filing for emergency use authorization for lenzilumab in late Q1 or early Q2 2022.

Humanigen, Inc. (NASDAQ: HGEN) announced its participation in multiple investor events in March 2022, focusing on the development of lenzilumab for treating cytokine storm associated with COVID-19. Key events include the Credit Suisse London Global Healthcare Conference (March 1-2), Oppenheimer March Thought Leadership Series (March 4), and the 34th Annual Roth Conference (March 13-15). Management aims to update stakeholders on the company's progress and extend its market reach through these engagements.

Humanigen, Inc. (Nasdaq: HGEN) announced that COO/CFO Timothy E. Morris will present at the 2022 BIO CEO & Investor Conference on February 15, 2022, at 11:30 AM ET in the Gotham room, Marriott Marquis, NYC, and virtually through the 17th. The event connects biotech firms and institutional investors, focusing on emerging public and private companies. The presentation slides will be available on Humanigen's website.

Humanigen (Nasdaq: HGEN) announces that lenzilumab is now available for specific hospitalized COVID-19 patients through the LenzMAP™ Managed Access Program, managed by Clinigen Group. This investigational product is accessible in 17 countries, including the UK and various European nations. The program will provide lenzilumab to patients deemed appropriate by healthcare professionals where local regulations permit. As Humanigen continues to pursue regulatory approvals for lenzilumab, the partnership with Clinigen aims to facilitate access to treatment for those in need.

Humanigen and Cenexi have entered a collaboration to establish Cenexi as the preferred supplier of lenzilumab in France and the European Union. This partnership includes a Master Supply Agreement for aseptic fill and finish services over five years. Humanigen will transfer technology to Cenexi to set up manufacturing processes at their facility in Normandy. The collaboration aims to secure funding and strengthen the supply chain for lenzilumab, particularly for COVID-19. Humanigen plans to file for early access authorization for lenzilumab by February 2022.

Humanigen has announced a peer-reviewed publication in the Journal of Medical Economics, highlighting the economic benefits of lenzilumab in treating COVID-19 patients. The treatment, combined with standard care, is associated with an estimated $13,190 cost savings per patient and a net savings of $3,190 after accounting for lenzilumab's price. This publication underscores the importance of cost-effective treatments, especially amid rising COVID-19 cases despite increased vaccinations. Humanigen aims to commercialize lenzilumab as a one-day treatment if authorized.

Humanigen, Inc. (Nasdaq: HGEN) has received FDA alignment on the registration pathway for the Phase 3 SHIELD clinical trial of lenzilumab. This trial aims to prevent CAR-T therapy-related toxicities such as ICANS and CRS in patients with relapsed or refractory Non-Hodgkin lymphoma. The randomized, double-blind trial is set to begin recruitment in H1 2022. It intends to demonstrate significant improvements in neurotoxicity and healthcare resource utilization. The SHIELD study follows positive results from the ZUMA-19 study, reflecting the potential for lenzilumab to address critical unmet needs in CAR-T therapy.