8-K
Neurogene Inc. (NGNE)
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): May 12, 2021
Neoleukin Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36327 | 98-0542593 |
|---|---|---|
| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
188 East Blaine Street, Suite 450
Seattle, Washington 98102
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (866) 245-0312
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 (see General Instruction A.2. below):
☐ 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 Global Market |
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.
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Item 2.02 Results of Operations and Financial Condition
On May 12, 2021, Neoleukin Therapeutics, Inc. (the “Company”) issued a press release announcing financial results for the quarter ended March 31, 2021. The full text of the press release announcing such results is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure
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 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this current report on Form 8-K and in Exhibits 99.1 and 99.2 attached hereto is being furnished, but shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and is not incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Number | Description |
|---|---|
| 99.1 | Press Release of Neoleukin Therapeutics, Inc. dated May 12, 2021 |
| 99.2 | Presentation of Neoleukin Therapeutics, Inc. dated May 2021 |
SIGNATURE
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 thereunto duly authorized.
Date: May 12, 2021
Neoleukin Therapeutics, Inc.
By: /s/ Robert Ho
Name: Robert Ho
Title: Chief Financial Officer
Document
Exhibit 99.1
Neoleukin Therapeutics Announces First Quarter 2021 Financial Results and Corporate Update
Entered clinical development with first patient dosed in Phase 1 Trial of NL-201 -
Appointed Priti Patel, M.D., as Chief Medical Officer -
Cash and cash equivalents of $178.4 million expected to fund operations into 2023 -
SEATTLE, Washington, May 12, 2021 – Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced financial results for the quarter ending March 31, 2021 and provided a corporate update.
“The first quarter of 2021 saw continued progress in expanding our de novo protein capabilities, preparing for clinical testing of NL-201, and appointing Priti Patel as Chief Medical Officer,” said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "It is exciting to begin enrolling patients in the NL-201 Phase 1 clinical trial and to become a clinical stage company."
Recent Updates
NL-201 Phase 1 Trial Underway
In May 2021, Neoleukin announced dosing of the first patient in a Phase 1 trial of NL-201.
NL-201 is a de novo protein that is designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, while potentially reducing the toxicities associated with high-dose IL-2. The Phase 1 study is planned to enroll up to 120 patients with advanced, relapsed, or refractory solid tumors. Patients will receive NL-201 as intravenous monotherapy to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. The Phase 1 study will be conducted at multiple sites in Australia and North America.
In addition to the systemic trial, Neoleukin is planning a trial of NL-201 to test local administration in order to achieve higher drug concentrations in the tumor microenvironment. Neoleukin expects the local administration trial to begin by the end of 2021.
De Novo Protein Design for Coronavirus – NL-CVX1
NL-CVX1 is a decoy protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19, and is designed to be resilient to viral mutational escape. In preclinical studies, NL-CVX1 protected Syrian hamsters from a lethal dose of SAR-CoV-2 after intranasal
administration. Neoleukin is evaluating a potential first-in-human trial of NL-CVX1, and will continue to assess the program as the SARS-CoV-2 landscape evolves.
Other Research Updates
Neoleukin has multiple research projects underway evaluating the applications of de novo protein technology to develop agonists and antagonists of immune pathways. Neoleukin currently plans to announce additional information about its pipeline program during the second half of 2021.
Executive Appointment
In May 2021, Neoleukin announced the appointment of Priti Patel, M.D., M.S., as Chief Medical Officer. Dr. Patel joins Neoleukin from AstraZeneca, where she served as Vice President, Head of Hematology Clinical Development since 2019. Previously, she served as Senior Medical Director and Executive Medical Director at Acerta Pharma before its acquisition by AstraZeneca, and as Medical Director at Onyx Pharmaceuticals (acquired by Amgen).
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $178.4 million as of March 31, 2021, compared to $192.6 million as of December 31, 2020.
Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into 2023.
R&D Expenses: Research and development expenses for the first quarter of 2021 increased to $9.7 million from $5.5 million for the first quarter of 2020. The increase was primarily due to increased expenses incurred from IND-enabling and clinical trial startup activities related to Neoleukin's lead product candidate, NL-201, and in connection with the advancement of other Neoleukin technologies.
G&A Expenses: General and administrative expenses for the first quarter of 2021 increased to $5.2 million from $3.6 million for the first quarter of 2020. The increase in general and administrative expenses was primarily due to increases in personnel-related costs and professional service fees as Neoleukin continues to grow its operations, along with facility related costs associated with the build-out of its new headquarters in Seattle, Washington.
Net Loss: Net loss for the first quarter of 2021 was $14.9 million compared to a net loss of $8.6 million in the first quarter of 2020 primarily due to Neoleukin's focus on its lead candidate, NL-201, and its de novo protein platform.
About Neoleukin Therapeutics, Inc.
Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. Neoleukin’s lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist
designed to improve tolerability and activity by eliminating the alpha receptor binding interface. For more information, please visit the Neoleukin website: www.neoleukin.com.
Safe Harbor / Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the therapeutic properties and potential of the company’s de novo protein design technology, the results of the clinical trial for NL-201, and planned clinical and development activities and timelines. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the company’s cash forecasts, the company’s ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, the timing and results of preclinical and clinical trials, the timing of announcements and updates relating to the company’s clinical trials and related data market conditions and further impacts of COVID-19, that could cause actual results to differ materially from what Neoleukin expects. Further information on potential risk factors that could affect Neoleukin’s business and its financial results are detailed under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Neoleukin undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts:
Media
Julie Rathbun
206-769-9219
Investors
Solebury Trout
Alexandra Roy
617-221-9197
NEOLEUKIN THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data
(In thousands of U.S. dollars)
| March 31, | December 31, | |||
|---|---|---|---|---|
| 2021 | 2020 | |||
| Assets | ||||
| Cash and cash equivalents | $ | 178,391 | $ | 192,556 |
| Other current assets | 2,915 | 1,966 | ||
| Non-current assets | 18,797 | 15,997 | ||
| Total assets | $ | 200,103 | $ | 210,519 |
| Liabilities | ||||
| Current liabilities | $ | 8,407 | $ | 7,889 |
| Non-current liabilities | 12,728 | 11,414 | ||
| Total liabilities | 21,135 | 19,303 | ||
| Stockholders' equity | 178,968 | 191,216 | ||
| Total liabilities and stockholders' equity | $ | 200,103 | $ | 210,519 |
NEOLEUKIN THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands of U.S. dollars, except per share and share amounts)
| Three months ended | ||||
|---|---|---|---|---|
| March 31, | March 31, | |||
| 2021 | 2020 | |||
| Operating expenses | ||||
| Research and development | $ | 9,707 | $ | 5,498 |
| General and administrative | 5,241 | 3,573 | ||
| Total operating expenses | 14,948 | 9,071 | ||
| Other income (loss), net | (2) | 429 | ||
| Net loss | $ | 14,950 | $ | 8,642 |
| Net loss per common stock - basic and diluted | $ | (0.27) | $ | (0.18) |
| Basic and diluted weighted average common shares outstanding | 54,944,421 | 49,168,451 |
ex-992xpresentationofneo
Forward Looking Statements
Leader in Therapeutic Protein Design First Program: Cancer Immunotherapy 2018 FOUNDED 2019 PUBLIC NL-201 program: Platform technology: de novo NASDAQ: NLTX 2020 IND SUBMISSION SEATTLE WA NL-201 2021 CLINICAL TRIALS Systemic Local
Functional De Novo Proteins Better Immunotherapies by Design de novo de novo 2019 2020
Neoleukin Progress in 2021
Carl Walkey, Ph.D. Senior VP, Corporate Development Previous: Postdoctoral Fellow, UW-IPD Priti Patel, M.D., M.S. Chief Medical Officer Previous: AstraZeneca, Acerta Pharma Umut Ulge, M.D., Ph.D. VP, Clinical Development Previous: Postdoctoral Fellow, UW-IPD Jonathan Drachman, M.D. Chief Executive Officer Previous: CMO, EVP R&D, Seattle Genetics Robert Ho Chief Financial Officer Previous: Morgan Stanley & Co., DaVita Samantha Willing VP, People Previous: Seattle Genetics, Microsoft Holly Vance, J.D., Pharm.D. General Counsel Previous: Bill & Melinda Gates Foundation Leadership Team
NL-201: De Novo IL-2/IL-15 Agonist Designed to retain benefits of IL-2 without drawbacks Nature α β hIL-2Neoleukin-2/15 and and
IL-2 Binds Strongly to Non-Target Cells, Causing Toxicity and Limiting Efficacy α β β IL-2 Off-Target Cells Effector Cells IL-2IL-2
Building a Neoleukin Cytokine Mimetic in 4 Steps 1 2 3 4
Crystal Structure Shows Neo-2/15 Binding Beta/Gamma as Predicted ALPHA BETA GAMMA IL-2 Neo-2/15 BETA GAMMA 14% Nature
NL-201 Stimulates CD8 Effector T and NK Cells More Selectively Than IL-2 0. 00 01 0. 00 1 0. 01 0. 1 1 10 10 0 1, 00 0 1,500 2,000 2,500 3,000 Treatment (nM) M e a n p S T A T 5 CD8 Signaling 11X 0. 00 01 0. 00 1 0. 01 0. 1 1 10 10 0 1, 00 0 1,500 1,750 2,000 2,250 2,500 2,750 Treatment (nM) NK Signaling 3.1X 0. 00 01 0. 00 1 0. 01 0. 1 1 10 10 0 1, 00 0 2,000 3,000 4,000 5,000 Treatment (nM) Treg Signaling 31X Walkey et. al, AACR Virtual Annual Meeting II, Abstract #4518, June 2020
NL-201 Stimulates Dose-Dependent CD8:Treg and NK:Treg Proliferation More Potently Than IL-2 0 0.3 1.0 3.0 10 30 0 1 2 3 4 5 6 7 Treatment (ng/ml) % K i6 7 + C D 8 :T re g CD8:Treg Proliferation 0 0.3 1.0 3.0 10 30 0 5 10 15 20 25 30 Treatment (ng/ml) % K i6 7 + N K :T re g NK:Treg Proliferation Walkey et. al, AACR Virtual Annual Meeting II, Abstract #4518, June 2020
NL-201 is Well Tolerated and Promotes Durable Anti-tumor Activity 0 7 14 21 28 35 0 1000 2000 3000 Study Day T u m o r V o lu m e ( m m 3 ) Re-Challenge 9 16 23 30 -5 0 5 10 15 20 25 30 Study Day % B o d y w e ig h t C h a n g e Tolerability ** 9 16 23 30 37 44 51 58 65 72 79 0 25 50 75 100 Study Day % T u m o rs < 1 0 0 0 m m 3 Tumor Growth Inhibition 6/15 (40%) tumor-freeNL-201 aPD-1 aPD-L1 Walkey et. al, AACR Virtual Annual Meeting II, Abstract #4518, June 2020
NL-201 Demonstrates Robust Single-Agent Activity in Multiple Tumor Models PBS NL-201 0 1000 2000 3000 4000 T u m o r V o lu m e ( m m 3 ) Hepa1-6 (Liver) Day 24 90% TGI PBS NL-201 0 1000 2000 3000 4000 T u m o r V o lu m e ( m m 3 ) LL/2 (Lung) Day 35 64% TGI PBS NL-201 0 1000 2000 3000 4000 MC38 (Colon) Day 21 88% TGI PBS NL-201 0 1000 2000 3000 4000 EMT-6 (Breast) Day 28 62% TGI PBS NL-201 0 1000 2000 3000 4000 CT26 (Colon) Day 21 78% TGI PBS NL-201 0 1000 2000 3000 Pan02 (Pancreatic) Day 52 60% TGI PBS NL-201 0 1000 2000 3000 4000 H22 (Liver) Day 18 77% TGI PBS NL-201 0 1000 2000 3000 4000 Renca (Kidney) Day 23 53% TGI PBS NL-201 0 1000 2000 3000 4000 5000 A20 (Lymphoma) Day 26 77% TGI PBS NL-201 0 1000 2000 3000 4000 B16F10 (Melanoma) Day 18 34% TGI PBS NL-201 0 1000 2000 3000 4000 5000 RM-1 (Prostate) Day 20 71% TGI PBS NL-201 1000 2000 3000 4000 B16BL6 (Melanoma) Day 22 28% TGI Walkey et. al, AACR Virtual Annual Meeting II, Abstract #4518, June 2020
NL-201 Shows Minimal Immunogenicity in NHPs 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 1 2 3 4 5 6 7 8 9 10 100 1000 10000 100000 Animal # A s s a y S ig n a l (A U ) HPC MPC LPC NC 5ug/kg 15ug/kg 50ug/kg Abstract #4518, Walkey et. al, AACR Virtual Annual Meeting II, June 2020
Similar Pharmacodynamics and Tolerability Observed in ADA+ vs ADA- NHPs Adapted from Abstract #4518, Walkey et. al, AACR Virtual Annual Meeting II, June 2020 Pr e 24 h 3d 5d 7d Pr e 24 h 3d 0 20 40 60 80 100 % K i6 7 + C D 8 + T C e ll s (% o f to ta l C D 8 + ) CD8+ Proliferation (5mg/kg) 1st Dose 5th Dose Pr e 24 h 3d 5d 7d Pr e 24 h 3d 0 20 40 60 80 100 CD8+ Proliferation (50mg/kg) 1st Dose 5th Dose Pr e 24 h 3d 5d 7d Pr e 24 h 3d 0 20 40 60 80 100 CD8+ Proliferation (15mg/kg) 1st Dose 5th Dose
NL-201 Phase 1 Clinical Trials Systemic administration: Local administration:
NL-201 Upregulates PD-1 Expression by CD8+ T Cells Walkey et. Al, SITC 2020, Abstract #576, November 2020
NL-201 Enhances Activity of Checkpoint Inhibitors in Preclinical Models NL-201 enhances activity of CPIs in breast and kidney cancer models Combination with NL-201 beneficial in CPI-resistant syngeneic tumors 0 7 14 21 28 35 42 0 20 40 60 80 100 Study Day % S u rv iv in g EMT-6 (Breast) Vehicle aPD-1 NL-201 NL-201 + aPD-1 7/9 tumor-free 0 7 14 21 28 35 42 0 20 40 60 80 100 Study Day % S u rv iv in g Renca (Kidney) Vehicle aPD-1 + aCTLA-4 NL-201 NL-201 + aPD-1 + aCTLA-4 5/9 tumor-free p=0.0001: ⍺ ⍺ ⍺ ⍺ p=0.0006: ⍺ ⍺ p=0.0029: ⍺ ⍺ p<0.0001: ⍺ NL-201: ⍺PD-1: ⍺CTLA-4: Treatment began when tumors reached ~90mm3
NL-201 Potently Expands CAR-T Cells and Promotes Antitumor Activity Subcurative doses of CAR-T cells combined with NL-201 induce deep tumor control and achieve 100% survival. NL-201 greatly enhances intratumoral CD8: Treg ratios (approximately 1000x compared to 50x for IL-2). Leung et. al, AACR Virtual Annual Meeting II, Abstract #2222, June 2020
NL-201 Enhances Activity of Tumor-Targeting Antibodies in Multiple Preclinical Models Walkey et. Al, SITC 2020, Abstract #576, November 2020
Neoleukin Cytokine Mimetics are Hyperstable and Easily Modified Nature
De Novo Split Technology - Conditionally Active IL-2 Mimetic Cell signaling (murine CTLL2 cells) Part A + B Quijano-Rubio et. Al., AACR Virtual Annual Meeting II, Abstract #1075, Jun/2020 Part-A Part-B Reconstituted Neo-2/15
Targeted Split Neo-2/15 Increases Therapeutic Window Weight change D12 Percent Survival ⍺ ⍺PDL1-Part A + ⍺PDL1-Part B (8 nmol) Quijano-Rubio et. Al., AACR Virtual Annual Meeting II, Abstract #1075, Jun/2020
De Novo Platform Potential – COVID-19 ACE2 NL-CVX1 - de novo ACE2 decoy Binds to SARS-CoV2 spike protein Inhibits viral infection in vitro Designed, tested, optimized in ~10 weeks Cell Virus Spike protein Cell Virus ACE2 Spike protein SARS-CoV-2 ACE2 NL-CVX1
NL-CVX1 – De Novo Protein Decoy De novo design of potent and resilient hACE2 decoys to neutralize SARS-CoV-2 T. W. Linsky et. al. Science. 10.1126/science.abe0075 (2020)
NL-CVX1 Inhibits SARS-CoV-2 Infection of Lung Cells In Vitro Linsky et. al. Science. 10.1126/science.abe0075 (2020)
Single Dose of NL-CVX1 Rescues Animals from Lethal SARS-CoV-2 Challenge 0 1 2 3 4 5 6 7 8 9 10 11 0 25 50 75 100 Days Post-Challenge S u rv iv a l 12h pre-challenge 0 1 2 3 4 5 6 7 8 9 10 11 80 85 90 95 100 105 Days Post-Challenge B o d y w e ig h t (% ) 12h pre-challenge Mock CTC445.2d Vehicle Linsky et. al. Science. 10.1126/science.abe0075 (2020)
Anticipated Milestones de novo
Financial Highlights
Improving on nature. Designing for life.