SHORT HILLS, NJ–(BUSINESS THREAD)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on the development of lenzilumab (LENZ®), a first-in-class antibody that neutralizes granulocyte-macrophage (GM) colony-stimulating factor. -CSF), today reported financial results for the second quarter and six months ended June 30, 2022.
“We have made excellent progress in the strategic readjustment announced in July. We have increased the number of sites for the PREACH-M study in Australia of lenzilumab in chronic myelomonocytic leukemia (‘CMML’), a rare blood cancer, and we have interest from major cancer centers in the United States. We are on track to enroll the first patient in the UK RATing study of lenzilumab in acute graft-versus-host disease (‘aGvHD’) and look forward to dosing soon,” said Cameron Durrant, President and CEO of Humanigen. “Given the positive results of the company’s LIVE-AIR study and the survival trend seen in the ACTIV-5/BET-B study, we have interest from a global group of institutions and leading research networks to include lenzilumab in their large-scale, multi-national studies of COVID-19. Tocilizumab and baricitinib demonstrated a mortality benefit after inclusion in these studies despite failing to do so in smaller studies. We are exploring the requirements for inclusion in these studies and plan to provide an update before the end of 2022. In addition, we are currently evaluating applications for investigator-initiated trials (‘IITs’) of lenzilumab in combination with CAR therapies -T and plans to continue development of ifabotuzumab (“iFab”), a monoclonal antibody targeting EpAh-3 currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”) for to certain solid tumors in Australia.”
As recently announced, the company has strategically aligned its pipeline and resources with plans to accelerate the development of lenzilumab in CMML, for which the “PREcision Approach to Chronic Myelomonocytic Leukemia” study is already underway or “PREACH-M” and to continue. the study “Risk Adapted Therapy in Acute GvHD”, or “RATinG”, in patients undergoing bone marrow transplantation, which is expected to enroll its first patient in the third quarter of 2022. These studies are mostly financed by the partners of the company As part of the realignment plan, the company will de-emphasize the deployment of certain resources for the development of lenzilumab for COVID-19. The preliminary results of the initial line of the Acceleration of Therapeutic Interventions and Vaccines for COVID-19-5 (“ACTIV-5”) and the Large Effect Trial, in the “B” arm of the trial ( “BET-B”), known as ACTIV The -5/BET-B trial indicated that lenzilumab demonstrated a positive trend in mortality. The Company continues to support the analysis of National Institutes of Health (“NIH”) data.
Financial results for the second quarter and six months ended June 30, 2022
Net loss for the quarter ended June 30, 2022 was $30.1 million, or $0.43 per share, compared to $70.8 million, or $1.20 per share, in quarter ended June 30, 2021. Net loss for the six months ended June 30, 2022 was $51.4 million, or $0.75 per share, compared to $136.4 million in dollars or $2.45 per share for the six months ended June 30, 2021. The decrease in net loss for both periods was largely due to a decrease in expenses, primarily research and development (“R” expense +D”). R&D expenses decreased $36.6 million from $63.0 million for the three months ended June 30, 2021 to $26.4 million for the three months ended June 30, 2022 and decreased $79.2 million from $122.9 million for the six months ended June 30, 2021, to $43 million. the six months ended June 30, 2022. The decrease in R&D expenses is primarily due to the decrease in lenzilumab manufacturing costs for the quarter ended June 30, 2022 of $34.6 million , and for the six months ended June 30, 2022 of $70.3 million.
Cash and cash equivalents
Net cash used in operating activities, net of balance sheet changes, was $44.8 million for the six months ended June 30, 2022. During the first half of 2022, the Company sell shares of its common stock under its “At Market” or “ATM,” raising net proceeds of approximately $21.8 million. As of June 30, 2022, the Company had cash and cash equivalents of approximately $47.0 million After the end of the quarter and through August 10, 2022, the Company raised an additional $15.9 million from ATM.
In July 2022, the Company repaid the term loan with Hercules by prepaying $25.0 million of outstanding principal, together with approximately $1.7 million of accrued interest, fees and other amounts due on by virtue of the loan, terminating all corresponding obligations, liens and guarantees. By retiring the term loan, the company reduced future cash payments for interest and improved its ability to generate additional liquidity from its intellectual property by eliminating collateral requirements for the loan.
A summary of ai’s financial highlights for the three and six months ended June 30, 2022 and 2021 is as follows (in thousands of dollars):
About Lenzilumab
Lenzilumab is Humaneered®’s proprietary first-in-class monoclonal antibody that has been shown to neutralize GM-CSF, a critically important cytokine in the hyper-inflammatory cascade, sometimes called cytokine release syndrome or cytokine storm. Humanigen believes that GM-CSF neutralization with lenzilumab also has the potential to treat patients with CMML and reduce the hyperinflammatory cascade known as cytokine release syndrome common to aGvHD. A study of lenzilumab is underway for CMML patients with RAS pathway mutations. This study builds on evidence from a phase 1 study, conducted by Humanigen, which showed that RAS mutations are associated with hyperproliferative features, which may be sensitive to GM-CSF neutralization. Lenzilumab will also be tested to evaluate its ability to prevent and/or treat GvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.
About Humanigen, Inc.
Humanigen, Inc. (NASDAQ: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company focused on the development of lenzilumab, a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor. Humanigen is developing lenzilumab as a treatment for chronic myelomonocytic leukemia and acute graft-versus-host disease. Humanigen is also exploring the use of lenzilumab to prevent toxicities associated with CAR-T therapy through investigator-initiated trials. Humanigen is also developing an antibody drug conjugate (ADC) using its EphA-3 targeted monoclonal antibody ifabotuzumab (“ifab”) for solid tumors. For more information, visit www.humanigen.com and follow Humanigen on Twitter.
Forward-looking statements
All statements other than statements of historical fact contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations about future performance or events. Although management believes that the expectations reflected in these statements are reasonable, they do not guarantee that such expectations will be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “attempt,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue” and similar expressions identify forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, the achievement of the required regulatory approvals and authorizations and the launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration; and the various risks and uncertainties described in the “Risk Factors” sections of our most recent annual and quarterly reports and other filings with the SEC.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely on any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statement made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially. of those foreseen in the forward-looking statements, in each case, unless the law requires it.
LENZ® and Humaneered® are trademarks of Humanigen, Inc.
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