UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Securities registered pursuant to Section 12(b) of the Act:
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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 (see General Instruction A.2. below):
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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 1.01 Entry into a Material Definitive Agreement.
On December 18, 2020, Allakos Inc. (the “Company”) entered into an additional ten-year commercial supply agreement (the “Supply Agreement”) with Lonza Sales AG (“Lonza”), pursuant to which Lonza has agreed to manufacture lirentelimab (AK002) for the Company, among other related services. Lonza is currently the Company’s sole manufacturer for lirentelimab (AK002).
Pursuant to the Supply Agreement, the Company will provide rolling forecasts to Lonza that reflect future manufacturing of lirentelimab (AK002) by Lonza.
The Supply Agreement may be terminated by either party before its expiration in the event of certain breaches of the Supply Agreement by the other party. In addition, the Company may terminate the Supply Agreement under other specified conditions.
The Supply Agreement includes customary indemnification, intellectual property protection, remedies and confidentiality terms, as well as certain quality requirements.
The foregoing summary of the Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Supply Agreement, a copy of which the Company anticipates filing as an exhibit to the Company’s Annual Report on Form 10-K for the period ending December 31, 2020.
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The information included in Item 1.01 of this Current Report on Form 8-K is incorporated into this Item 2.03 of this Current Report on Form 8-K by reference.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On December 21, 2020, the Board of Directors (the “Board”) of Allakos Inc. (the Company”), upon the recommendation of the Corporate Governance and Nominating Committee of the Board, increased the size of the Board to seven members and appointed Natalie Holles to the Board to fill the newly created directorship, effective immediately. Ms. Holles will serve as a Class II director of the Company, to hold office until the Company’s 2023 annual meeting of stockholders and until her successor is elected and qualified, or until her earlier death, resignation or removal. The Board has determined that Ms. Holles satisfies the applicable independence requirements of the Nasdaq Listing Rules.
Following the date of her appointment to the Board, Ms. Holles shall receive options to purchase 15,400 shares of the Company’s common stock pursuant to the Company’s 2018 Equity Incentive Plan. One thirty-sixth of the shares subject to the options shall vest each month following the commencement of Ms. Holles’s service, subject to her continued service to the Company on each such vesting date.
Ms. Holles will participate in the Company’s Outside Director Compensation Policy, which was amended and restated as of April 1, 2020. Under the policy, non-employee directors receive an annual cash retainer of $47,500 (plus additional amounts for committee service, if appointed), an initial grant of a stock option upon joining the Board (described above), and an annual stock option covering 7,700 shares of common stock.
Additionally, the Company and Ms. Holles have entered into an indemnification agreement in substantially the same form that the Company has entered into with each of its existing directors.
On December 22, 2020, the Company issued a press release to announce the appointment of Ms. Holles to the Board, A copy of the press release issued concerning the appointment is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Allakos Inc. |
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Date: December 22, 2020 |
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/s/ Robert Alexander |
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Robert Alexander |
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Chief Executive Officer |
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Exhibit 99.1
Allakos Appoints Natalie Holles to its Board of Directors
REDWOOD CITY, Calif., December 22, 2020 – Allakos Inc. (NASDAQ: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today announced the appointment of Natalie Holles, president and chief executive officer of Audentes Therapeutics, to the Allakos board of directors.
“Natalie’s extensive background in company-building and commercial readiness makes her an exceptional addition to our board and will provide valuable insights as we continue to advance late-stage clinical trials of lirentelimab and begin laying the foundation for its potential commercialization,“ said Robert Alexander, PhD, chief executive officer of Allakos.“
Ms. Holles has contributed to the leadership and success of several biotechnology companies. She has more than two decades of experience in senior-level leadership, business development, corporate strategy and commercial operations across a range of therapeutic areas. Ms. Holles is currently the President and Chief Executive Officer of Audentes Therapeutics (acquired by Astellas Pharma in 2020) which she joined in 2015 as Chief Operating Officer. Prior to joining Audentes, Ms. Holles served as senior vice president, corporate development at Hyperion Therapeutics (acquired by Horizon Pharma in 2015). Earlier in her career, Ms. Holles served as vice president, business development at KAI Pharmaceuticals (acquired by Amgen in 2012) and also held corporate development and commercial roles at InterMune (acquired by Roche in 2014).
Ms. Holles is a member of the Board of Directors for Rubius Therapeutics. She holds an M.A. in molecular, cellular and developmental biology from the University of Colorado, Boulder, where she was a Howard Hughes Medical Institute predoctoral fellow, and an A.B. in human biology from Stanford University.
“I am honored to join the Allakos Board of Directors, and I share the company’s vision of developing innovative therapies that transform patients’ lives,” said Ms Holles. “I look forward to working with existing board members and the Allakos management team to support their goal of developing and commercializing a unique treatment for people with eosinophilic gastrointestinal diseases.”
About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.
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Source: Allakos Inc.
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Investor Contact: |
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Media Contact: |
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Adam Tomasi, President, COO and CFO |
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Denise Powell |
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ir@allakos.com |
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denise@redhousecomms.com |