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): November 14, 2022
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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).
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Item 2.02 Results of Operations and Financial Condition
On November 14, 2022, Neoleukin Therapeutics, Inc. (the “Company”) issued a press release announcing financial results for the quarter ended September 30, 2022. 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 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | |||||||
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: November 14, 2022
Neoleukin Therapeutics, Inc.
By: /s/ Jonathan G. Drachman
Name: Jonathan G. Drachman
Title: President and Chief Executive Officer
EX-99.1
Neoleukin Therapeutics Announces Third Quarter 2022 Financial Results and Corporate Update
–Development of NL-201 to be discontinued for strategic reasons –
–Company to focus on next-generation de novo proteins and core technology –
–Company restructuring to extend cash runway into the second half of 2025 –
SEATTLE, Washington, November 14, 2022 – 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 third quarter ended September 30, 2022 as well as a strategic decision to discontinue development of NL-201, a fully de novo IL-2/IL-15 agonist, and focus on advancing next-generation de novo protein therapeutics based on Neoleukin's expertise in designing and testing novel cytokine mimetics and experience with advanced machine learning.
"We will be using the information we have learned from the development of NL-201 and advances in protein design to build the next generation of de novo protein therapeutics," said Jonathan Drachman, M.D., Chief Executive Officer at Neoleukin. "We expect to focus on technology that widens the therapeutic window, such as the development of targeted and conditionally activated molecules to create potent immune agonists. We believe we are well positioned to do this work based on our expertise in de novo protein design combined with our experience in advanced machine learning and neural networks, which allows us to predict and create structures for de novo proteins with more sophisticated and dynamic structural elements than was previously possible."
"This coincides with a strategic decision to discontinue development of NL-201, which we believe was the first fully de novo protein to be evaluated in clinical trials," said Dr. Drachman. "We are grateful to the patients and families that participated in this Phase 1 trial and to the investigators and study personnel who enabled rapid testing of NL-201 during a global pandemic."
EX-99.1
Discontinuation of NL-201 Development
Neoleukin announced today that it is discontinuing development of NL-201, its first de novo cytokine mimetic to be tested in patients. Preliminary monotherapy data from the Phase 1 study of NL-201 demonstrated engagement of the target receptor, expected pharmacodynamic changes for a potent IL-2/IL-15 agonist, and did not demonstrate significant immunogenicity even after multiple cycles of therapy—an important de-risking of the potential for de novo proteins that may be administered over many weeks and months. However, based on a review of the preliminary data, the expected benefit to risk ratio for patients, and recent developments in the field of IL-2 therapeutics, Neoleukin determined that the resources required to continue development would be better applied to advancing the next generation of de novo protein therapeutics.
Corporate Reorganization
As a result of the decision to discontinue development of NL-201, on November 12, 2022, Neoleukin's Board of Directors approved a restructuring plan, including a reduction in force of approximately 40%. Cost savings as a result of this reduction in force as well as the discontinuation of development of NL-201 are expected to extend Neoleukin's existing cash runway into the second half of 2025.
Summary of Financial Results
Cash Position: Cash, cash equivalents, and short-term investments totaled $106.9 million as of September 30, 2022, compared to $142.5 million as of December 31, 2021.
R&D Expenses: Research and development expenses for the third quarter of 2022 decreased to $9.5 million from $9.9 million for the third quarter of 2021. The decrease was primarily due to a decrease in personnel-related costs, partially offset by increases in costs related to the Phase 1 clinical trial of NL-201.
G&A Expenses: General and administrative expenses for the third quarter of 2022 decreased to $4.1 million from $5.6 million for the third quarter of 2021. The decrease was primarily attributable to decreases in personnel-related and facility-related costs.
Net Loss: Net loss for the third quarter of 2022 was $13.1 million compared to a net loss of $15.4 million in the third quarter of 2021.
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.
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, cost and timing of discontinuing the clinical trial for NL-201, expectations regarding the planned corporate restructuring and any cost savings therefrom, expectations regarding cash forecasts, and planned clinical and development activities and
EX-99.1
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 company's ability to protect its intellectual property, the timing and results of preclinical and clinical trials, changes to laws or regulations, market conditions, geopolitical events, 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” included in Neoleukin's Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K filed from time to time with the Securities and Exchange Commission (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
jrathbun@neoleukin.com
Investors
Solebury Trout
Alexandra Roy
617-221-9197
investors@neoleukin.com
EX-99.1
NEOLEUKIN THERAPEUTICS, INC.
Condensed balance sheet data
(In thousands of U.S. dollars)
| September 30, | December 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| Assets | |||||||||||
| Cash, cash equivalents, and short-term investments | $ | 106,878 | $ | 142,467 | |||||||
| Other current assets | 1,979 | 1,522 | |||||||||
| Non-current assets | 17,719 | 19,274 | |||||||||
| Total assets | $ | 126,576 | $ | 163,263 | |||||||
| Liabilities | |||||||||||
| Current liabilities | $ | 10,237 | $ | 8,636 | |||||||
| Non-current liabilities | 10,692 | 11,763 | |||||||||
| Total liabilities | 20,929 | 20,399 | |||||||||
| Stockholders' equity | 105,647 | 142,864 | |||||||||
| Total liabilities and stockholders' equity | $ | 126,576 | $ | 163,263 | |||||||
EX-99.1
NEOLEUKIN THERAPEUTICS, INC.
Condensed statements of operations and comprehensive income (loss)
(In thousands of U.S. dollars, except per share and share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development | $ | 9,471 | $ | 9,896 | $ | 22 | $ | 31,128 | $ | 29,402 | |||||||||||||
| General and administrative | 4,138 | 5,556 | 13,718 | 16,122 | |||||||||||||||||||
| Total operating expenses | 13,609 | 15,452 | 44,846 | 45,524 | |||||||||||||||||||
| Loss from operations | (13,609) | (15,452) | (44,846) | (45,524) | |||||||||||||||||||
| Interest income | 559 | 6 | 766 | 14 | |||||||||||||||||||
| Other income (loss), net | (22) | — | (32) | (15) | |||||||||||||||||||
| Net loss | $ | (13,072) | $ | (15,446) | $ | (44,112) | $ | (45,525) | |||||||||||||||
| Comprehensive income (loss): | |||||||||||||||||||||||
| Unrealized loss on available-for-sale securities | (20) | — | (92) | — | |||||||||||||||||||
| Comprehensive loss | $ | (13,092) | $ | (15,446) | $ | (44,204) | $ | (45,525) | |||||||||||||||
| Net loss per share – basic and diluted | $ | (0.24) | $ | (0.28) | $ | (0.80) | $ | (0.83) | |||||||||||||||
| Basic and diluted weighted average common shares outstanding | 55,251,039 | 55,087,777 | 55,199,822 | 55,020,059 | |||||||||||||||||||
Corporate Presentation November 2022 © Neoleukin Therapeutics. All Rights Reserved. Exhibit 99.2
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, expectations and timing of the Company's strategic plans for development, the potential for future clinical development of 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, properties of its product candidates, availability of data, the use and 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: the ability of the Company to execute on its strategic plan, including success in development of new immunotherapies, the ability to bring any development candidates forward from the research phase into development and approval for clinical trial; its ability to obtain and maintain regulatory approval for any product candidates and the potential safety, efficacy or clinical utility of or any product candidates; cost and timing expectations for the discontinuation of NL-201; further impacts of COVID-19, supply chain disruptions, or other global economic and geopolitical events on its operations; and other factors discussed in the “Risk Factors” section and elsewhere in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and subsequent reports 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. 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. © Neoleukin Therapeutics. All Rights Reserved.2
© Neoleukin Therapeutics. All Rights Reserved.3 We use protein design to reinvent how therapies are created with a goal to meaningfully improve patients’ lives Neoleukin is a pioneer in de novo protein development, leveraging computational methods to create new therapies. This new approach has unlimited potential to treat human disease by improving on nature, designing for life. We are building a company with a vibrant and inclusive culture that we believe will make a meaningful impact for patients, our people and our community.
2018 2019 2020 2021 2022 FUTURE NEOLEUKIN FOUNDED Computational methods enable fully de novo protein design Scientists and technology spun out of University of Washington MERGER COMPLETED NASDAQ listing (NLTX) after merger with Aquinox More than $140M raised through merger and follow-on offering FIRST IND SUBMITTED First IND of fully de novo protein (NL-201) Neoleukin scientists create second fully de novo protein (NL- CVX1) PHASE 1 TRIAL INITIATED First patients treated with fully de novo protein MACHINE LEARNING Machine learning/neural network technology enables rapid drug discovery EXPAND DE NOVO PROTEIN PIPELINE Multiple fully de novo molecules expected to enter development in oncology and autoimmune diseases Innovative approaches to drug delivery, conditional activation, and affinity optimization to improve therapeutic index Neoleukin: Leader in de novo Protein Therapeutics © Neoleukin Therapeutics. All Rights Reserved.4
Leadership Team @Neoleukin Therapeutics. All Rights Reserved.5 Carl Walkey, Ph.D. Senior VP, Corporate Development P R I O R Postdoctoral Fellow, UW-IPD Priti Patel, M.D., M.S. Chief Medical Officer P R I O R AstraZeneca Acerta Pharma Jonathan Drachman, M.D. Chief Executive Officer P R I O R CMO, EVP R&D Seagen Sean Smith VP, Finance P R I O R Aptevo Therapeutics KPMG Bill Arthur, Ph.D. VP & Head of Research P R I O R Seagen Merck & Co. Donna Cochener General Counsel, SVP Legal P R I O R HomeStreet Davis Wright Tremaine
Better Therapies by Design Functional de novo proteins © Neoleukin Therapeutics. All Rights Reserved.6 2019 2020 • Scientific founders are world leaders in de novo protein design • Technology originated at University of Washington Institute for Protein Design • Exclusive license obtained for commercialization of NL-201 and other de novo protein assets
De Novo Protein Design • Amino acids are nature’s building blocks for proteins • The order they are arranged in determines how a protein folds, what it binds to, and what it does • Decades of research into protein folding, thermodynamics, and advances in computational power has resulted in the ability to design proteins that have never existed before © Neoleukin Therapeutics. All Rights Reserved.7 AMINO ACIDS PEPTIDE PROTEIN Neoleukin is leading the revolution in de novo protein therapeutics
Neoleukin™ de novo design methodology © Neoleukin Therapeutics. All Rights Reserved.8 IL-2R alpha IL-2R gamma IL-2 IL-2 IL-2R beta NL-201 NL-201 IL-2 Develop an accurate structural model of target Identify regions of intermolecular contact Design an idealized topology Assign optimal amino acid sequences 1 2 3 4 • High-resolution structural models of native ligand-receptor interactions guide design • Iterative process from multiple scientific disciplines to refine designs • Early methods focused on less complex structures
Evolution of Neoleukin™ De Novo Protein Technology Accelerating speed and accuracy © Neoleukin Therapeutics. All Rights Reserved.9 • New methodology combines machine-learning (ML) based sequence design and structure prediction with high-throughput screening. • ML-based methods enable more efficient protein design with higher success rates and using a fraction of the computing power. • We can now develop from a more expanded landscape of protein topologies that were not accessible by traditional methods. Predicted Structure In Silico Validation ML-based protein design High-throughput Screening Lead Optimization Fi tn es s
Adding Machine Learning to Protein Design Building the next generation of de novo proteins New methods are required to tackle more complex topologies © Neoleukin Therapeutics. All Rights Reserved.10 4-helix bundle Some cytokine families have complex structures
NL-201: de novo non-alpha IL-2/IL-15 agonist Potent, stable, no bias toward Tregs or endothelial cells © Neoleukin Therapeutics. All Rights Reserved.11 hIL-2Neoleukin-2/15 NL-201 is a de novo protein designed with no alpha subunit interaction and increased beta/gamma binding Source: Silva et al. Nature, 565, 186-191 (2019) 14% Conserved sequence α β γ
NL-201 Demonstrates Robust Single-Agent Activity in Multiple Tumor Models © Neoleukin Therapeutics. All Rights Reserved.12 • NL-201 was administered QWx2 when tumors reached ~100mm3 • Tumor growth inhibition (TGI) is reported in each graph vs. control. • NL-201 significantly inhibited tumor growth in all models, including those that are refractory to checkpoint inhibitors PBS NL-201 0 1000 2000 3000 4000 Tu m o r V o lu m e (m m 3 ) Hepa1-6 (Liver) Day 24 90% TGI (p<0.0001) PBS NL-201 0 1000 2000 3000 4000 Tu m o r V o lu m e (m m 3 ) LL/2 (Lung) Day 35 64% TGI (p<0.0001) PBS NL-201 0 1000 2000 3000 4000 MC38 (Colon) Day 21 88% TGI (p<0.0001) PBS NL-201 0 1000 2000 3000 4000 EMT-6 (Breast) Day 28 62% TGI (p<0.001) PBS NL-201 0 1000 2000 3000 4000 CT26 (Colon) Day 21 78% TGI (p<0.001) PBS NL-201 0 1000 2000 3000 Pan02 (Pancreatic) Day 52 60% TGI (p<0.01) PBS NL-201 0 1000 2000 3000 4000 H22 (Liver) Day 18 77% TGI (p<0.0001) PBS NL-201 0 1000 2000 3000 4000 Renca (Kidney) Day 23 53% TGI (p<0.01) PBS NL-201 0 1000 2000 3000 4000 5000 A20 (Lymphoma) Day 26 77% TGI (p<0.001) PBS NL-201 0 1000 2000 3000 4000 B16F10 (Melanoma) Day 18 34% TGI (p=0.01) PBS NL-201 0 1000 2000 3000 4000 5000 RM-1 (Prostate) Day 20 71% TGI (p<0.0001) PBS NL-201 1000 2000 3000 4000 B16BL6 (Melanoma) Day 22 28% TGI (p=0.008) Walkey et. al, AACR Virtual Annual Meeting II, Abstract #4518, June 2020
Similar Pharmacodynamic Response in ADA+ vs ADA- NHPs © Neoleukin Therapeutics. All Rights Reserved.13 Pre 24 h 3d 5d 7d Pre 24 h 3d 0 20 40 60 80 100 % K i6 7+ C D 8+ T C el ls (% o f to ta l C D 8+ ) CD8+ Proliferation (5mg/kg) 1st Dose 5th Dose ADA- ADA+ Pre 24 h 3d 5d 7d Pre 24 h 3d 0 20 40 60 80 100 CD8+ Proliferation (50mg/kg) 1st Dose 5th Dose Pre 24 h 3d 5d 7d Pre 24 h 3d 0 20 40 60 80 100 CD8+ Proliferation (15mg/kg) 1st Dose 5th Dose Walkey et. al, AACR Virtual Annual Meeting II, Abstract #4518, June 2020
De Novo Split Technology: Conditionally Active IL-2 Mimetic © Neoleukin Therapeutics. All Rights Reserved.14 Cell signaling (murine CTLL2 cells) N or m al ize d pS TA T5 M FI Neo-2/15 Part A Part B Part A + B Quijano-Rubio et. al., AACR Virtual Annual Meeting II, Abstract #1075, Jun 2020 Neo-2/15 Part-A Neo-2/15 Part-B Reconstituted Neo-2/15 IL2-Rβ IL2-RƔ
Targeted Split Neo-2/15 Increases Therapeutic Window © Neoleukin Therapeutics. All Rights Reserved.15 • C57BL/6J mice bearing B16 PDL1Hi melanoma cells in flank • All groups were co-treated biweekly with Ta99 mAb (150µg/mice) • Targeted Neo-2/15 variants and Part-A fusions administered i.p.; Part-B fusions administered s.c. opposite flank of tumor % W ei g h t c h an g e Weight change D12 Days after tumor inoculation Percent Survival PBS ⍺PDL1-Neo-2/15 (0.43 nmol) Untargeted-Part A + Untargeted-Part B (8 nmol) ⍺PDL1-Part A + ⍺PDL1-Part B (8 nmol) Quijano-Rubio et. al., AACR Virtual Annual Meeting II, Abstract #1075, Jun 2020
Highly Selective De Novo Treg Expander and Activator • Highly tuned CD122/CD132 activator fused to Treg-targeting domain • Potential to specifically expand Tregs for the treatment of autoimmune diseases and inflammation • Finely tuned de novo protein to achieve optimal affinity and potency for specificity and cis-activation • Demonstrated ability to drive specificity by targeting de novo cytokine mimetics • Upcoming oral presentation at ASH on Dec. 12, 2022 © Neoleukin Therapeutics. All Rights Reserved.16 Tuned IL-2 receptor agonist Treg binding domain
De Novo Platform Potential: COVID-19 © Neoleukin Therapeutics. All Rights Reserved.17 NL-CVX1 - de novo ACE2 decoy: • Binds to SARS-CoV2 spike protein • Inhibits viral infection in vitro SARS-CoV-2 uses ACE2 as a receptor to gain access to and infect cells ACE2 Cell Virus Spike protein Cell Virus ACE2 Spike proteinNL-CVX1 De Novo protein designed, tested, and optimized in the pre-clinical setting in ~10 weeks
Neo-5171: A computationally designed de novo protein inhibitor of IL-2 and IL-15 signaling © Neoleukin Therapeutics. All Rights Reserved.18 • Potent inhibitor of CD8 T-cell proliferation and IFN-g production • Resistant to proteases and low pH • Less impact on T-regulatory cells R. Swanson et. al. Am. Coll Rheum. (ACR) 2021; Abstract 1438, Nov 2021 Control Neo-5171 + 1 nM IL-2 * * In presence of 30 pM aCD3
Neo-5171-Fc prolongs survival in a preclinical model of graft-vs-host disease (GVHD) © Neoleukin Therapeutics. All Rights Reserved.19 • Immunodeficient NSG mice were irradiated, received 107 human PBMC on Day -1 • Intraperitoneal dosing with Neo-5171-Fc q3d, beginning Day 0 • Mice were euthanized when experiencing >20% body weight loss • At high dose 62.5% of mice survived at study end (Day 42) R. Swanson et. al. Am. Coll Rheum. (ACR) 2021; Abstract 1438, Nov 2021
NL-201 Update • In November 2022, we made a strategic decision to discontinue development of NL-201 and focus on advancing the next generation de novo protein therapeutics • NL-201 Phase 1 experience demonstrates potential of using de novo proteins in humans • Demonstrated engagement of target receptors and expected pharmacodynamic changes • Preliminary data did not indicate significant risk of immunogenicity • Based on a review of preliminary data, the expected benefit-to-risk ratio for patients, and recent developments in the field of IL-2 therapeutics, we determined that the resources required to continue development would be better applied to advancing the next generation of de novo protein therapeutics. © Neoleukin Therapeutics. All Rights Reserved.20
Financial Highlights and Strategic Restructuring Financial Highlights • $106.9 million cash, cash equivalents, and short-term investments as of September 30, 2022 • Cash position expected to fund operations into the second half of 2025 • 42.6M common shares outstanding and 12.7M pre-funded warrants1 Strategic Restructuring • Along with the decision to discontinue development of NL-201, we are implementing a restructuring plan that includes a reduction in force of approximately 40% • Cost savings as a result of this reduction in force as well as the discontinuation of development of NL-201 are expected to extend our cash runway into the second half of 2025 © Neoleukin Therapeutics. All Rights Reserved.21 1. Warrants to purchase common shares 1:1 with an exercise price of $0.000001 as of September 30, 2022.
Improving on nature. Designing for life. © Neoleukin Therapeutics. All Rights Reserved.