Neurogene Inc 8-K, filed Jan 13, 2020
Neurogene Inc. (NGNE)
About this 8-K
Neurogene Inc filed this 8-K on January 13, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2020
Neoleukin Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36327 | 98-0542593 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
360-1616 Eastlake Avenue East
Seattle, Washington 98102
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (206) 732-2133
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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, $0.000001 par value | NLTX | The Nasdaq Stock Market LLC |
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 7.01. | Regulation FD Disclosure |
Neoleukin Therapeutics, Inc. (the “Company”) has prepared investor presentation materials with information about the Company, which it intends to use as part of investor presentations. A copy of the investor presentation materials to be used by management for presentations is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished with this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Presentation | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEOLEUKIN THERAPEUTICS, INC. | ||||
| Date: January 13, 2020 | By: | /s/ Kamran Alam | ||
| Kamran Alam | ||||
| Interim Chief Financial Officer | ||||
Exhibit 99.1
De novo proteins for immunotherapy January 2020
Forward Looking Statements Certain of the statements made in these slides and the accompanying oral presentation are forward looking, including those relating to Neoleukin’s business, strategy, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding timing of regulatory submissions and initiation of clinical trials, regulatory requirements for initiation of clinical trials and registration of product candidates, the sufficiency of its cash resources and other statements containing the words “anticipate,” “believe,” “expect,” “may,” “plan,” “project,” “potential,” “will,” “would,” “could,” “continue,” and similar expressions. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: whether results of early clinical trials or preclinical studies will be indicative of the results of future trials, the adequacy of any clinical models, uncertainties associated with regulatory review of clinical trials; our ability to identify or acquire additional clinical candidates, our ability to obtain and maintain regulatory approval for any product candidates and the potential safety, efficacy or clinical utility of or any product candidates, and other factors discussed in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 as filed with the Securities and Exchange Commission. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by the Company is contained in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, and subsequent reports, filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. © 2020 Neoleukin Therapeutics. All Rights Reserved. Do not distribute or reproduce 2
Leader in De Novo Protein Design for Immunotherapy Neoleukin Therapeutics (NASDAQ: NLTX) founded in 2018; merged with Aquinox Pharmaceuticals to become public company in August 2019 Closed follow-on offering in December 2019 Platform technology utilizes computational methods for de novo protein design of NeoleukinTM cytokine mimetics Lead program: NL-201, a highly potent, non-alpha, agonist of IL-2 and IL-15 receptors for cancer immunotherapy Headquarters in Seattle; 39 employees © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 3
Leadership Team Jonathan Drachman, M.D. Kamran Alam Daniel-Adriano Silva, Ph.D. Chief Executive Officer Chief Financial Officer (Interim) VP, Head of Research Previous: CMO, EVP R&D, Previous: CFO Aquinox Previous: Translational Investigator, Seattle Genetics IPD, UW Carl Walkey, Ph.D. Umut Ulge, M.D., Ph.D. Leslie Aberman, J.D. Samantha Willing VP, Corporate Development VP, Translational Medicine VP, IP & Legal Affairs VP, People Previous: Postdoctoral Fellow, Previous: Postdoctoral Fellow, Previous: IDRI, Previous: Seattle Genetics, IPD, UW UW Seattle Genetics Microsoft © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 4
Board of Directors Jonathan G. Drachman, M.D. Todd Simpson Cantey Boyd Director Lead Independent Director Director CEO and President, CFO Managing Director, Neoleukin Therapeutics Seattle Genetics Baker Brothers Advisors Sarah Noonberg, M.D. Lewis T. Williams, M.D., Ph.D. Sean Nolan Director Director Director Previous: CMO, Nohla Therapeutics CEO Walking Fish Therapeutics Previous: CEO, AveXis Previous: CEO, FivePrime Therapeutics 5 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Functional De Novo Proteins: Better Immunotherapies by Design Computational algorithms invented by Daniel-Adriano Silva at UW IPD NL-201: IL-2/IL-15 cytokine mimetic (Neoleukin™) for cancer immunotherapy Discovery published in Nature January 2019 Company formed to advance technology platform and lead asset © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 6
Neoleukin Therapeutics: Pioneers in De Novo Protein Design Technology originated at University of Washington’s Institute for Protein Design, led by David Baker, PhD Scientific founders are world leaders in de novo protein design Exclusive license obtained for commercialization of NL-201 and other de novo protein assets Investigating additional NeoleukinTM cytokine mimetics for cancer, inflammation, and autoimmunity © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 7
The Good and Bad of Interleukin-2 (IL-2) Immunotherapy ✅IL-2 one of the few immunology drugs proven to work as single-agent ✅Stimulates T cells to fight cancer ✅rhIL-2 (Proleukin®) approved for RCC and melanoma â—‹ Durable remissions in 5-8% of patients âŒVascular leak syndrome, cytokine storm are frequent side effects âŒTreatment administered in hospital due to significant toxicity âŒLow doses generally insufficient for activity © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 8
IL-2 Binds Strongly to Non-Target Cells, Causing Toxicity and Limiting Efficacy IL-2 IL-2 IL-2 á â â É£ É£ Off-Target Cells Effector T Cell Toxicity & Less Antitumor activity Efficacy © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 9
Building a NeoleukinTM Cytokine Mimetic in 4 Steps Step 1: Step 2: Step 3: Step 4: Develop an accurate Identify regions of Design an idealized Identify optimal structural model of intermolecular topology amino acid sequence the target contact © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 10
Crystal Structure Shows Neo-2/15 Binding IL-2Râ/É£ as Predicted Neo-2/15 há (CD25) hIL-2 hâ hÉ£ Co-crystal structure of IL-2 Co-crystal structure Neoleukin-2/15 Source: Silva et al. Nature, 565, 186-191 (2019) (14% linear sequence identity) 11 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Neo-2/15 Binds IL-2Rβ/É£ Without Detectable Binding to IL-2Rα In Vitro Neo-2/15 á â É£ Concentration (M) 12 Source: Silva et al. Nature, 565, 186-191 (2019) © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Neo-2/15 Is More Active than IL-2 in CT26 Murine Colon Cancer Model mor cell implantation Neo-2/15 Neo-2/15 13 Source: Silva et al. Nature, 565, 186-191 (2019) © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Neo-2/15 Demonstrates Superior Activity and Lower Toxicity than IL-2 In Murine Melanoma Model B16 melanoma model in combination with mAb TA99 Survival Percent Source: Silva et al. Nature, 565, 186-191 (2019) 14 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Neo-2/15 Enhances CD8:Treg Ratio Naive mice • N = 2-3 mice/group • Daily dosing x 14 days Source: Silva et al. Nature, 565, 186-191 (2019) 15 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Neo-2/15 Does Not Elicit Detectable Immunogenicity in Mice Sequence identity 14% by sequence alignment 29% by structural alignment Mice (N = 10/group) received intraperitoneal Neo-2/15 or mIL-2, x14 days; 10mcg/day Source: Silva et al. Nature, 565, 186-191 (2019) 16 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
NL-201 Improves on Nature: Designed to retain benefits of IL-2 without drawbacks ✓ Hyperstable ✓ No binding to alpha chain ✓ Dual immune mechanisms ✓ Higher affinity activated binding than natural protein ✓ Potent IL-2 activation ✓ No bias toward ✓ Potent IL-15 activation endothelial cells or T-regulatory cells © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 17
IL-2/IL-15 Competitive Landscape Other significant IL-2/IL-15 immunotherapies in development are modified versions of native IL-2 or IL-15 IL-2 modification often results in a less potent, less stable molecule, with some residual binding to the alpha subunit We believe NL-201 is the only IL-2 agonist specifically designed with no alpha-binding region NL-201 potently agonizes both IL-2 and IL-15 receptors, potentially stimulating complementary cancer-fighting pathways © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 18
NeoleukinTM Cytokine Mimetics are Hyperstable and Easily Modified Can use with targeting domain to improve biodistribution Able to adjust half-life or tune afinity Can be conditionally activated in the tumor microenvironment Able to withstand extreme conditions Can be modified to make cytokine antagonists for inflammatory and autoimmune diseases 19 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
NL-201: On Track for IND by End of 2020 CMC: process developed and GLP tox batch successfully produced Toxicology: multi-dose, non-GLP and GLP tox studies conducted in rats and non-human primates â—‹ GLP in-life dosing complete; no unexpected toxicity observed Bioassays: GLP and clinical bioassays in development and on track to support IND submission and clinical studies Pharmacology: multiple models under evaluation 20 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce
Financial Highlights $66.3 million cash & cash equivalents as of Sept. 30, 2019 Follow-on offering in December 2019 raised ~$81M (net) ~38 million common shares outstanding and ~11 million pre-funded warrants after follow-on Cash and cash equivalents expected to fund operations through 2022 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 21
Upcoming Milestones Event Timeline Present Preclinical and Scientific Data 1H 2020 Submit IND for NL-201 By end of 2020 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce 22
life. 23 © 2020 Neoleukin Therapeutics. All Rights Reserved: Do not distribute or reproduce