UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition |
On March 3, 2022, NextCure, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2021. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
The information furnished in this Item 2.02 (including Exhibit 99.1) shall not be deemed to be “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, and is not incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 7.01 | Regulation FD Disclosure |
Beginning on March 3, 2022, the Company will be hosting calls with members of the investment community, which may reference presentation materials. The Company is furnishing a copy of such presentation materials, which is attached hereto as Exhibit 99.2.
The information furnished in this Item 7.01 (including Exhibit 99.2) shall not be deemed to be “filed” for purposes of the Exchange Act, or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing under the Securities Act, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits. |
Exhibit |
Description | |
| 99.1 | Press release issued by NextCure, Inc. dated March 3, 2022 | |
| 99.2 | NextCure, Inc. Presentation dated March 3, 2022 | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
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.
| NEXTCURE, Inc. | |
| Date: March 3, 2022 | |
| /s/ Steven P. Cobourn | |
| Steven P. Cobourn | |
| Chief Financial Officer |
Exhibit 99.1
NextCure Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results
| – | Multiple data readouts expected in 2022, including updates for all three clinical programs |
| – | Ends 2021 with cash position of $219.6 million that is expected to fund operations into first quarter of 2024 |
BELTSVILLE, Md. – March 3, 2022 -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today reported fourth quarter and full year 2021 financial results and provided a business update.
“In 2021, NextCure set the stage for multiple data readouts in 2022. This year, we intend to have important updates on NC318, NC410, and NC762,” said Michael Richman, NextCure’s president and chief executive officer. “Additionally, we expect our year-end cash position of $219.6 million to fund us into the first quarter of 2024.”
Business Highlights
| · | NC318 |
| · | Combined Phase 1 and 2 data presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting showed early evidence of potential clinical benefit in patients with lung cancer, squamous cell carcinoma of the head and neck, breast cancer and other advanced/metastatic solid tumors. |
| · | Preclinical data presented at the American Society of Hematology (ASH) Annual Meeting suggest that Siglec-15 (S15) may be targeted therapeutically with compounds such as NC318 to activate T lymphocytes against leukemia cells. Knock-out of S15 in a murine model resulted in leukemia clearance in immunocompetent recipients and 100% survival across all recipients. |
| · | NC410 |
| · | Interim Phase 1 data presented at the SITC Annual Meeting showed that NC410 appears to be safe and well-tolerated in patients with advanced tumors and demonstrated evidence of immune modulation. |
| · | Preclinical data published in the online journal Frontiers in Immunology indicated that collagen fragments in the tumor microenvironment (TME) can mediate T cell suppression through LAIR-1, and this suppression could subsequently be reversed by a LAIR-2 fusion protein like NC410. |
| · | NC762 |
| · | Continued to enroll patients and advance the program to report initial Phase 1 clinical data in the second half of 2022. |
| · | NC525 |
| · | Introduced our fourth program, which targets LAIR-1 expression with a novel mechanism of action that kills acute myeloid leukemia (AML) blasts and leukemia stem cells with minimal effect on hematopoietic stem and progenitor cells. |
| · | Preclinical data presented at the ASH Annual Meeting appear to show that NC525 could preferentially target and kill LAIR-1 expressing AML stem cells with minimal effect on healthy hematopoietic stem and progenitor cells. |
| · | Appointed Ellen G. Feigal, M.D., a Partner and Head of the Biologics Practice at NDA Partners LLC, and Anne Borgman, M.D., former Vice President and Global Therapeutic Area Lead, Hematology-Oncology, at Jazz Pharmaceuticals, to the Board of Directors. |
| · | Appointed Elizabeth Jaffee, M.D., Ursula Matulonis, M.D., and Weiping Zou, M.D., Ph.D., to the NextCure Scientific Advisory Board. |
Expected Upcoming Milestones
The widespread impact of the COVID-19 pandemic, including the emergence of the Omicron variant, has impacted enrollment and operations at certain clinical trial sites involved in NextCure’s ongoing trials. As a result, some milestones have been delayed. NextCure has taken multiple steps intended to drive enrollment and will continue to institute measures designed to mitigate the impact of the pandemic.
| · | NC318 Phase 2 update: fourth quarter of 2022 (Amended Phase 2: S15+ selection with CLIA assay, 800 mg dosed Q1W). |
| · | NC318 anti-PD-1 Combo (Yale University Investigator-Initiated trial): second half of 2022. |
| · | NC410 Phase 1 update: second half of 2022. |
| · | NC762 initial Phase 1 data: second half of 2022. |
| · | NC525 Investigational New Drug Application (IND) filing: fourth quarter of 2022. |
Financial Guidance
Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.
Financial Results for Fourth Quarter and Full Year Ended December 31, 2021
| · | Cash, cash equivalents, and marketable securities, excluding restricted cash as of December 31, 2021, were $219.6 million as compared with $283.4 million as of December 31, 2020. The decrease of $63.8 million as of December 31, 2021, as compared to December 31, 2020, primarily reflects cash used to fund operations of $57.2 million. |
| · | Research and development expenses were $50.2 million and $12.3 million for the year and quarter ended December 31, 2021, respectively, as compared with $46.6 million and $12.1 million for the year and quarter ended December 31, 2020, respectively. The increase was driven primarily by clinical-related and personnel-related costs, partially offset by timing of research and manufacturing supply costs. |
| · | General and administrative expenses were $20.6 million and $4.8 million for the year and quarter ended December 31, 2021, respectively, as compared with $17.0 million and $4.1 million for the year and quarter ended December 31, 2020, respectively. The increase was primarily related to personnel-related costs. |
| · | Revenue was not recognized for the year ended December 31, 2021, as compared with $22.4 million for the year ended December 31, 2020. Revenue generated in 2020 was from our former research and development agreement with Eli Lilly. |
| · | Net loss was $69.4 million and $16.9 million for the year and quarter ended December 31, 2021, respectively, as compared with $36.6 million and $15.5 million for the year and quarter ended December 31, 2020, respectively. The changes in net loss for the year and quarter were primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount, offset by the recognition for the year ended 2020 of the remaining deferred revenue under the former research and development agreement with Eli Lilly. |
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases. Through our proprietary FIND-IO™ platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. Our initial focus is to bring hope and new treatments to patients who do not respond to current cancer therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies. http://www.nextcure.com
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to NextCure as of the date hereof. Forward-looking statements include statements regarding NextCure’s expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “may,” “will,” “potential,” “expects,” “believes,” “intends,” “hope,” “towards,” “forward,” “later” and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the development plans for our immunomedicines, statements about the progress and evaluation and expected timing of results of NextCure’s ongoing clinical trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, expectations regarding the investigator initiated trial conducted by Yale, the expected timing of results of NextCure’s ongoing clinical trial of NC410, the development plans for NC762, NextCure’s financial guidance, expected upcoming milestones, and NextCure’s plans, objectives and intentions with respect to the discovery and development of immunomedicines. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the impacts of the COVID-19 pandemic on NextCure’s business, including NextCure’s clinical trials, third parties on which NextCure relies and NextCure’s operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and no products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on NextCure’s FIND-IO™ platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including in Item 1A of NextCure’s most recent Form 10-K and elsewhere in the Company’s filings with the SEC. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, except as required by law, even if expectations change.
—
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
| Selected Financial Information |
| Selected Statement of Operations Items: | Year Ended | |||||||
| December 31, | ||||||||
| (in thousands, except share and per share amounts) | 2021 | 2020 | ||||||
| Revenue: | ||||||||
| Revenue from former research and development arrangement | $ | — | $ | 22,378 | ||||
| Operating expenses: | ||||||||
| Research and development | 50,192 | 46,554 | ||||||
| General and administrative | 20,573 | 17,049 | ||||||
| Loss from operations | (70,765 | ) | (41,225 | ) | ||||
| Other income, net | 1,376 | 4,622 | ||||||
| Net loss | $ | (69,389 | ) | $ | (36,603 | ) | ||
| Net loss per common share - basic and diluted | $ | (2.51 | ) | $ | (1.33 | ) | ||
| Weighted-average shares outstanding - basic and diluted | 27,615,977 | 27,532,177 | ||||||
| Selected Balance Sheet Items: | Year Ended | |||||||
| December 31, | ||||||||
| (in thousands) | 2021 | 2020 | ||||||
| Cash, cash equivalents, and marketable securities | $ | 219,591 | $ | 283,448 | ||||
| Total assets | 242,386 | 306,644 | ||||||
| Accounts payable and accrued expenses | 6,391 | 8,528 | ||||||
| Total stockholder's equity | 233,386 | 293,721 | ||||||
Exhibit 99.2
Next Generation Immunomedicines March 2022
PROPRIETARY AND CONFIDENTIAL 2 2 Forward - Looking Statements This presentation contains forward - looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 . These statements are based on current expectations, forecasts, assumptions and other information available to NextCure as of the date hereof . Forward - looking statements include statements regarding NextCure’s expectations, beliefs, intentions or strategies regarding the future and can be identified by forward - looking words such as “may,” “will,” “potential,” “expects,” “believes,” “intends,” “hope,” “towards,” “forward,” “later” and similar expressions . Examples of forward - looking statements in this press release include, among others, statements about the development plans for our immunomedicines , statements about the progress and evaluation and expected timing of results of NextCure’s ongoing clinical trial of NC 318 , expectations regarding the potential benefits, activity, effectiveness and safety of NC 318 , expectations regarding the investigator initiated trial conducted by Yale, the expected timing of results of NextCure’s ongoing clinical trial of NC 410 , the development plans for NC 762 , NextCure’s financial guidance, expected upcoming milestones, and NextCure’s plans, objectives and intentions with respect to the discovery and development of immunomedicines . Forward - looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward - looking statement . Such risks and uncertainties include, among others : the impacts of the COVID - 19 pandemic on NextCure’s business, including NextCure’s clinical trials, third parties on which NextCure relies and NextCure’s operations ; positive results in preclinical studies may not be predictive of the results of clinical trials ; NextCure’s limited operating history and no products approved for commercial sale ; NextCure’s history of significant losses ; NextCure’s need to obtain additional financing ; risks related to clinical development, marketing approval and commercialization ; the unproven approach to the discovery and development of product candidates based on NextCure’s FIND - IO Ρ platform ; and dependence on key personnel . More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including in Item 1 A of NextCure’s most recent Form 10 - K and elsewhere in the Company’s filings with the SEC . You should not place undue reliance on any forward - looking statements . Forward - looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward - looking statements, except as required by law, even if expectations change .
PROPRIETARY AND CONFIDENTIAL 3 3 3 • NC318 (S15): Phase 2 monotherapy & combo therapy • NC410 (LAIR - 2): Phase 1 monotherapy • NC762 (B7 - H4): Phase 1 monotherapy • NC525 (LAIR - 1): IND Q4 2022 PIPELINE Progress • Patient selection increasing probability of success • Biomarkers for detecting early activity • Potential for combination therapy • FIND - IO discovery platform PRODUCT Strategy • Experienced team • Fully integrated GMP manufacturing team PEOPLE Experience NextCure Highlights NC762 (B7 - H4) NC318 (S15) NC410 (LAIR - 2) Phase 1 Phase 2 Phase 1 NC525 (LAIR - 1) IND Q4 2022
PROPRIETARY AND CONFIDENTIAL 4 4 NC318, NC410, NC762 On Track BUILDING PIPELINE Momentum RUNWAY Q1 2024 EXPERIENCED Team Significant Momentum & Milestones in 2022
PROPRIETARY AND CONFIDENTIAL 5 5 Advancing Product Development Pipeline PROGRAMS TARGET CELLS DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NEXT MILESTONE PRODUCT CANDIDATES NC318 S15 Tumors and macrophages Phase 2 update Q4 2022 NC318 Anti - PD - 1 Combo* S15 Tumors and macrophages Initial Data 2H 2022 NC410 LAIR - 2 ECM Phase 1 update 2H 2022 NC762 B7 - H4 Tumors Initial Phase 1 data 2H 2022 NC525 LAIR - 1 Leukemic Stem Cells IND filing Q4 2022 DISCOVERY AND RESEARCH PROGRAMS Multiple Programs Multiple Targets Multiple cell types IND filing in 2023 NSCLC, BREAST, H&N NSCLC, H&N, GASTRIC, CRC, CERVICAL NSCLC NSCLC, BREAST, OVARIAN *Investigator - initiated (IIT) trial (Yale University) Worldwide Rights to All Programs AML
PROPRIETARY AND CONFIDENTIAL 6 6 Product Development: Getting it Right Patient Selection Biomarkers Combos Triangulation Strategy Unmet Needs of Cancer Patients • Non - Responders • Rapid Progression • Limited Treatments We Need New Solutions
PROPRIETARY AND CONFIDENTIAL 7 7 NC318 Humanized Siglec - 15 (S15) Monoclonal Antibody Phase 2 CLINICAL TRIALS BIOLOGY MOA HIGHLIGHTS • NSCLC, Breast, H&N • Evidence of disease control • Evidence of enhanced outcomes in S15+ patients Suppressed T Cell • Decreases suppressive myeloid cells & pro - tumorigenic cytokines • Promotes T cell function & IFN - g production
PROPRIETARY AND CONFIDENTIAL 8 8 NC318 Mechanism of Action Tumor cell Inactive T cell Distinct S15 - induced myeloid cells M2 macrophage Myeloid cell Immunosuppression and tumor growth Increase in inflammatory cytokines Differentiation and survival OR S15 S15 Tumor cell M2 macrophage Myeloid cell OR S15 S15 NC318 Dead tumor cell Differentiation and survival Decreases inflammatory cytokines Promotes T cell proliferation & restores function Tumor killing S15 is Immunosuppressive in the Tumor Microenvironment NC318 Blocks Immunosuppressive Activity Induced by S15
PROPRIETARY AND CONFIDENTIAL 9 9 Time to & Duration of Disease Control 1 SD subjects in other types of cancer include Esophageal cancer (n=1), Endometrial cancer (n=1), Hepatocellular carcinoma (n=1), Melanoma (n=3), Merkel cell carcinoma (n=1), and SCC/Basaloid (n=1). 0 150 25 50 100 Weeks H&N Breast Ovarian Other 1 Lung CR Start • n = 32 • NSCLC 1CR & 1PR remain on therapy for 2.8 and 2.3 years, respectively • H&N and Breast PRs were on study for 40 and 21 weeks respectively PR Start SD Start On Study CR 2.8 years PR 2.3 years PR 40 weeks PR 21 weeks
PROPRIETARY AND CONFIDENTIAL 10 10 Analysis in All Patients: Early Evidence of Disease Control Without S15 Selection in Ph1 & Ph2 Cancer Types Responses n=32 Disease Control ( CR+PR+SD ) n=32 (37%) Progressive Disease (n=54) Total Evaluable Subjects (n=86) 2 mPFS in Disease Control (5.0 months) Lung 1 CR, 1 PR, 13 SD 15 (45%) 18 33 5.2 3 H&N 1 PR 1 (20%) 4 5 N/A Breast 1 PR, 3 SD 4 (40%) 6 10 4.8 Ovarian 4 SD 4 (24%) 13 17 4.0 4 Other 1 8 SD 8 (38%) 13 21 5.1 1 SD subjects in other types of cancer include Esophageal Cancer (n=1), Endometrial Cancer (n=1), Hepatocellular Carcinoma (n=1 ), Melanoma (n=3), Merkel cell carcinoma (n=1), and SCC/Basaloid (n=1) 2 Total of 96 subjects were treated with 10 subjects determined as non - evaluable (NE) for efficacy based on RECIST v1.1 and or clinical evaluations by principal investigators (PIs) 3 3 SD subjects were censored for PFS analysis 4 1 SD subject lost to follow up for PFS analysis N/A: Not Applicable is used where sample size is less than 3 for median analysis. The data extract date is as of 18AUG2021
PROPRIETARY AND CONFIDENTIAL 11 11 Retrospective Analysis: Disease Control Rate Increased in S15+ Patients Subjects treated with NC318 (n=96) IHC available & evaluable (n=39) n=9 n=30 S15 Positive 1 (n=15) S15 Negative (n=24) n=3 n=21 n=6 n=9 • Lung = 5 • Other = 3 • Breast = 1 • Lung = 3 • Other = 2 • Ovarian = 1 • Lung = 8 • Ovarian = 6 • HNSCC = 3 • Breast = 2 • Other = 2 • Lung = 2 • Breast = 1 SD PD SD PD 40% Disease Control 12% Disease Control 1 H score ≥1
PROPRIETARY AND CONFIDENTIAL 12 12 NC318 Restores Immune Function in a Highly Suppressive TME UPCOMING MILESTONES Amended Phase 2 • S15+ selection (CLIA assay) • 800 mg Q1W: drug exposure • NSCLC, H&N and breast • Update 4Q 2022 Yale Phase 2 (Combo) NSCLC • Mono therapy: PD - 1 refractory • Pembro combo: PD - 1 refractory • Pembro combo: PD - 1 naïve • Initial data 2H 2022
PROPRIETARY AND CONFIDENTIAL 13 13 NC410 LAIR - 2 (Collagen - Binding) Fusion Protein Decoy BIOLOGY MOA HIGHLIGHTS Phase 1/2 CLINICAL TRIAL • Targets LAIR - 1/LAIR - 2 pathway • Enhances T cell infiltration and tumor killing • Patient selection assay • Evidence of immune activation • Synergistic combinations • 2021 posters & publications ‒ ASCO ‒ SITC ‒ eLife ‒ Frontiers in Immunology
PROPRIETARY AND CONFIDENTIAL 14 14 Scientific Advancement in Understanding Collagen Biology Elevated collagen correlates with PD - 1/ PD - L1 resistance Changes in collagen expression correlate with worse prognosis LAIR - 2 & NC410 sensitizes tumors 2020 2019 2019 2021 collagen collagen Collagen collagen Science Translational Medicine Science Translational Medicine Nature Communication eLife Collagen Frontiers in Immunology 2021
PROPRIETARY AND CONFIDENTIAL 15 15 NC410 Mechanism of Action Tumor - specific Collagen NC410 Collagen is Immunosuppressive NC410 Normalizes Immune System Remodeled Collagen NC410 Infiltration Inhibited T Cell Activated T Cells • Physical barrier; excludes T cell from TME • Inhibits T cells Dead tumor cells Tumor cells
PROPRIETARY AND CONFIDENTIAL 16 16 NC410: Key to Unlock TME and Normalize Immune Response TME ACCESS LOCKED NC410 UNLOCKS ECM REMODELING & NORMALIZATION Inactive T cell Many “keys” but none fit lock Enhances T cell infiltration Activated T cell Activated T cells kill tumor
PROPRIETARY AND CONFIDENTIAL 17 17 NC410 Safety & Early Efficacy Data from Cohorts 1 - 5 • 5 SD subjects had time - on - study up to 42, 25+, 20, 16 and 16, respectively • 3 active subjects ongoing: one at 25+ and two at 5+ weeks • 3+3 design • Dosing every 2 weeks • Solid tumors • No DLTs through cohort 5 • Two subjects reported with worsening Grade 3: lymphopenia (1); anemia (1); no treatment related grade 4 adverse events were reported Phase 1b Dose Expansion • Confirm PK and PD • Biopsy analysis • Determine RP2D Phase 1a Dose Escalation Cohort 1 3 mg Cohort 2 6 mg Cohort 3 15 mg Cohort 4 30 mg Cohort 5 60 mg Cohort 6 100 mg Cohort 7 200 mg Cohort 8 400 mg Ongoing 30 mg Data cut off September 13, 2021 3 mg 6 mg 6 mg 6 mg 15 mg 60 mg 15 mg 3 mg 3 mg 60 mg 30 mg 60 mg 60 mg 15 mg 60 mg 30 mg 30 mg 15 mg
PROPRIETARY AND CONFIDENTIAL 18 18 NC410 Demonstrates Synergistic Activity in Preclinical Models PD - L1 PD - L1 TGF - β TRAP 0 10 20 30 40 0 400 800 1200 1600 2000 Days Post Tumor Injection T u m o r V o l u m e ( m m 3 ) NC410 -PD-L1 Control Combination Horn et al., SITC 2020
PROPRIETARY AND CONFIDENTIAL 19 19 NC410 Remodels ECM Enhancing Immune Infiltration & Tumor Killing Phase 1 monotherapy update 2H 2022 UPCOMING MILESTONE NC410 appears safe and well tolerated with no DLTs up to cohort 5; dose escalation continues Binding to C1q and collagen, modulates and restores immune function Increase in T cells, remodeling of ECM, and enhanced infiltration of T cells supports MOA SUMMARY
PROPRIETARY AND CONFIDENTIAL 20 20 NC762 Humanized B7 - H4 Monoclonal Antibody BIOLOGY MOA HIGHLIGHTS Phase 1/2 CLINICAL TRIAL • Initiated Phase 1 trial • IHC assay for patient selection • Biomarkers • AACR 2021 poster • Initial Phase 1 data 2H 2022 • Unique mechanism of action • Inhibits tumor cell growth & is not dependent on T cells • NK cells enhance anti - tumor activity
PROPRIETARY AND CONFIDENTIAL 21 21 NC762 Inhibits Human Melanoma Tumor Growth In Vivo Activity Enhanced by Human PBMCs TUMOR INHIBITION 0 10 20 30 40 0 500 1000 1500 2000 2500 Days post inoculation T u m o r V o l u m e ( m m 3 ) PBS NC762 NC762.FES **** **** **** **** *** *** Control NC762 NC762.FES* *Designed to reduce Fc γ R binding/restrict ADCC activity T CELLS NOT REQUIRED + T cells (closed circles) ‒ T cells (open circles) NKs ENHANCE ACTIVITY 0 10 20 30 40 0 500 1000 1500 2000 2500 Days post inoculation T u m o r V o l u m e ( m m 3 ) **** **** Control B1H10 # + NK cells (closed circles) ‒ NK cells (open circles) # Parent of NC762 Archer et al., AACR 2021
PROPRIETARY AND CONFIDENTIAL 22 22 NC762 Summary & Upcoming Milestones Unique MOA • mAb inhibits tumor cell growth • Not dependent on immune cell infiltration into TME • NK cells enhance activity IND filed with FDA Initiated Phase 1 trial UPCOMING MILESTONE Initial Phase 1 data 2H 2022 SUMMARY
PROPRIETARY AND CONFIDENTIAL 23 23 New Program - NC525 (LAIR - 1 mAb) BIOLOGY MOA UPDATE • LAIR - 1 expression ‒ High on AML blasts and leukemia stem cells (LSCs) ‒ Minimal on hematopoietic stem and progenitor cells ( HSPCs ) NC525 IND Q4 2022 • Inhibits colony formation of AML LSCs in vitro • Inhibits AML growth in MV4 - 11 derived xenografts • Restricts AML progression in patient - derived xenografts Kills AML Blast Cells & LSCs Spares HSPCs
PROPRIETARY AND CONFIDENTIAL 24 24 Finding Solutions with a Powerful Discovery Engine F unctional, I ntegrated, N extCure D iscovery in I mmuno - O ncology • T cell activation • Cytokine release • Proliferation • Apoptosis • Effector function • Pathway reporters FUNCTIONAL READOUTS • Primary • Cell lines • Lymphoid • Myeloid • Tumor CELL TYPES • Membrane proteins • Soluble proteins • Small molecules • Soluble factors TARGET LIBRARIES
PROPRIETARY AND CONFIDENTIAL 25 25 GMP Manufacturing Facility: Benefits of Added Capacity Operational and capital efficiency Speed Flexibility Quality Use of a CMO adds ~ 8 months to timelines Efficiency Prioritization and scheduling Controlling quality with experienced team 2,000L Capacity Utilized to Produce Clinical Material for All Lead Programs
PROPRIETARY AND CONFIDENTIAL 26 26 Advancing Product Development Pipeline PROGRAMS TARGET CELLS DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NEXT MILESTONE PRODUCT CANDIDATES NC318 S15 Tumors and macrophages Phase 2 update Q4 2022 NC318 Anti - PD - 1 Combo* S15 Tumors and macrophages Initial Data 2H 2022 NC410 LAIR - 2 ECM Phase 1 update 2H 2022 NC762 B7 - H4 Tumors Initial Phase 1 data 2H 2022 NC525 LAIR - 1 Leukemic Stem Cells IND filing Q4 2022 DISCOVERY AND RESEARCH PROGRAMS Multiple Programs Multiple Targets Multiple cell types IND filing in 2023 NSCLC, BREAST, H&N NSCLC, H&N, GASTRIC, CRC, CERVICAL NSCLC NSCLC, BREAST, OVARIAN *Investigator - initiated (IIT) trial (Yale University) Worldwide Rights to All Programs – Partnership Opportunities AML
PROPRIETARY AND CONFIDENTIAL 27 27 Significant Momentum & Milestones in 2022 ON TRACK NC318, NC410, NC762 MOMENTUM Building Pipeline Q1 2024 Runway TEAM Experienced