UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 25, 2022

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Humanigen, Inc.

(Exact name of registrant as specified in its charter)

830 Morris Turnpike, 4th Floor

Short Hills, New Jersey 07078

(Address of principal executive offices and zip code)

(973) 200-3010
(Registrant's telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 1.02 Termination of a Material Definitive Agreement.

In connection with the adoption of the strategic realignment plan disclosed below in Item 8.01 of this Current Report on Form 8-K, on July 25, 2022, Humanigen, Inc. (the “Company”) made a prepayment of $26.7 million to satisfy in full all of the Company’s principal and interest obligations and related fees under that certain Loan and Security Agreement effective as of March 10, 2021 (the “Loan Agreement”), by and between the Company and each of its Qualified Subsidiaries (as defined in the Loan Agreement), on the one hand, and Hercules Capital, Inc. (the “Agent”) as administrative agent and collateral agent for itself and the lenders thereunder and the several banks, financial institutions or entities affiliated with the Agent from time to time parties to the Loan Agreement, on the other hand. As a result of the prepayment, the lenders’ commitments to extend further credit to the Company terminated, all obligations, covenants, debts and liabilities of the Company under the Loan Agreement were satisfied and discharged in full, the Loan Agreement and all other documents entered into in connection with the Loan Agreement were terminated, all liens or security interests granted to secure the Company’s obligations under the Loan Agreement were terminated, and all guaranties of the obligations of under the Loan Agreement were terminated.

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On July 25, 2022, the Company’s Board of Directors approved the grant of stock option awards to the Company’s executive officers and directors. The grants are intended to enhance the Company’s ability to retain its executive officers and provide them continuing incentives to execute against the strategic realignment plan announced in the Company’s press release issued July 26, 2022, and in recognition of the commitments of the directors in developing and overseeing the same. The options are expected to be granted on July 27, 2022 with exercise prices equal to the closing price of a share of the Company’s common stock as reported by The Nasdaq Stock Market, LLC on that date, and will vest pursuant to their terms in two equal tranches on the first and second anniversaries of the grant date. The grant date fair values of the awards made to the Company’s executive officers are expected to be approximately 40% of the respective executive officers’ base salaries for 2022.

Item 8.01. Other Events.

On July 26, 2022, the Company issued a press release announcing a strategic realignment of its clinical development pipeline and resources. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

SIGNATURE

Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Exhibit 99.1

Humanigen Implements Strategic Realignment of Pipeline and Resources to Achieve Key Clinical Milestones

SHORT HILLS, NJ.--(Newsfile Corp. July 26, 2022) - Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), today 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 (“CMML”), a 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 in 3Q22. These studies are majority funded by our clinical partners.

As part of this realignment, Humanigen expects to significantly reduce its go-forward, cash-based operating expenses including elimination of ongoing lenzilumab manufacturing, significant reduction in other R&D costs, and some reduction in general and administrative expenses through headcount reduction as well as other initiatives.

Key elements of the strategic realignment plan include:

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.

There have been no new therapeutic agents for patients with high-risk CMML in 30 years⁵ and independent publications have demonstrated the key role of GM-CSF and RAS pathway mutations in this and other cancers, including juvenile myelomonocytic leukemia (“JMML”), myelodysplastic syndromes, myeloproliferative neoplasms, and acute myeloid leukemia.^6,7,8

“We remain committed to advancing the scientific effort to prove the clinical benefits of neutralizing GM-CSF in life-threatening conditions for patients and have had to take difficult though necessary measures to do so,” said Cameron Durrant, Chairman and CEO, Humanigen. “Sharpening our in-house pipeline focus and partnering other resource-intensive programs may enable Humanigen and its clinical partners to rapidly derive important data in these indications. Our CMML, aGvHD programs are already primarily funded by partners and we hope to utilize a similar approach with our other programs, reducing our cash-based R&D expenses. We believe this strategic plan offers an opportunity to return value to our stockholders while providing hope to patients with serious and life-threatening conditions for improved outcomes.”

About Humanigen

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company focused on developing 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 use of lenzilumab to prevent toxicities associated with CAR-T therapy through investigator-initiated trials. Humanigen is also developing an antibody drug conjugate (ADC) utilizing 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 facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to 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," "intend," "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, the 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, attainment of the requisite regulatory authorizations and approvals and 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 latest 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 upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements 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 from those anticipated in the forward-looking statements, in each case, except as required by law.

References

Humanigen Investor Relations

Tim Morris

COO & CFO

tmorris@humanigen.com

650-400-6874

Source: Humanigen, Inc.