UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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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 8, 2024
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Item 7.01 Regulation FD Disclosure.
As previously announced, on January 8, 2024, Nurix Therapeutics, Inc. (the “Company”) will present an overview of the Company’s performance in 2023 and its major goals for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference (the “JPM Conference”). A copy of the Company’s presentation materials for the JPM Conference is attached as Exhibit 99.1 hereto and is incorporated herein by reference. Also on January 8, 2024, the Company issued the press release attached as Exhibit 99.2 hereto, which is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K 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 liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. In addition, the information set forth under this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
The following exhibits are filed herewith and this list is intended to constitute the exhibit index:
| Exhibit No. | Exhibit Title or Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | 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.
| NURIX THERAPEUTICS, INC. | ||||||||
| Date: January 8, 2024 | By: | /s/ Christine Ring | ||||||
| Christine Ring, Ph.D., J.D. | ||||||||
| Chief Legal Officer | ||||||||
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Leader in Targeted Protein Modulation Nurix Therapeutics Blazing a New Path in Medicine Investor Presentation January 2024 Exhibit 99.1
2 Important notice and disclaimers This presentation contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this presentation, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix Therapeutics, Inc. (“Nurix”, the “Company,” “we,” “us” or “our”), may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding our future financial or business plans; our future performance, prospects and strategies; future conditions, trends, and other financial and business matters; our current and prospective drug candidates; our ability to fund our operating activities into the second quarter of 2025; the planned timing and conduct of the clinical trial programs for our drug candidates; the planned timing for the provision of clinical updates and initial findings from our clinical studies; the potential benefits of our collaborations, including potential milestone and sales-related payments; the potential advantages of our DELigase™ platform and drug candidates; the extent to which our scientific approach, our DELigase™ platform, targeted protein modulation, and Degrader-Antibody Conjugates may potentially address a broad range of diseases; the extent animal model data predicts human efficacy; and the timing and success of the development and commercialization of our current and anticipated drug candidates. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) risks and uncertainties related to Nurix’s ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of clinical trials; (iii) Nurix’s ability to fund development activities and achieve development goals; (iv) risks and uncertainties relating to the timing and receipt of payments from Nurix's collaboration partners, including milestone payments and royalties on future potential product sales; (v) the impact of macroeconomic events and conditions, including increasing financial market volatility and uncertainty, inflation, increasing interest rates, instability in the global banking system, uncertainty with respect to the federal budget, the impact of war, military or regional conflicts, and global health pandemics, on Nurix’s clinical trials and operations; (vi) Nurix’s ability to protect intellectual property and (vii) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter ended August 31, 2023, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this presentation speak only as of the date of this presentation, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal estimates and research are reliable, such estimates and research have not been verified by any independent source.
Targeted Protein Modulation: TPM = TPD + TPE Nurix Drugs Engage Ligases for the Treatment of Cancer Targeted Protein Degradation (TPD) Ubiquitin is ligated to target proteins to tag them for degradation by the proteasome Inhibit ligases to increase specific protein levels Harness ligases to decrease specific protein levels Targeted Protein Elevation (TPE) A Powerful Cellular System 3
• Led the field of BTK degraders demonstrating clinical efficacy across B-cell malignancies with the potential to displace BTK inhibitors by addressing drug resistance and scaffolding effects • Expanded therapeutic focus into inflammation & immunology with IRAK4 degrader licensed by Gilead and plans to enable NX-5948 development in autoimmune disease • Established first of its kind strategic collaboration with Seagen (now part of Pfizer) to advance an innovative new class of ADC cancer therapeutics called Degrader-Antibody Conjugates or DACs 4 Major Accomplishments by Nurix in 2023 Setting the stage for both near-term and long-term value creation
MOA Oncology program Target Therapeutic area Discovery – Lead Op IND enabling Phase 1a Phase 1b TPD NX-2127 BTK-IKZF B-cell malignancies NX-5948 BTK B-cell malignancies TPE NX-1607 CBL-B Immuno-Oncology TPD Multiple Undisclosed Undisclosed Multiple Undisclosed Undisclosed Multiple Undisclosed Undisclosed DAC Multiple Undisclosed Oncology Nurix Is Advancing a Pipeline of Propriety and Partnered Programs in Oncology and Inflammation & Immunology 5 MOA I&I program Target Therapeutic area Discovery – Lead Op IND enabling Phase 1a Phase 1b TPD NX-5948 BTK Inflammation / autoimmune NX-0479 / GS-6791 IRAK4 Rheumatoid arthritis and other inflammatory diseases Multiple Undisclosed Inflammation / autoimmune
Advancing a New Therapeutic Class Degrader-Antibody Conjugates (DACs) 6 • DACs combine the catalytic activity of a Targeted Protein Degrader (TPD) with the specificity of an antibody • DACs represent the next generation of antibody drug conjugates (ADCs) • $60 million upfront cash payment • $3.4 billion in potential research, development, regulatory and commercial milestone payments • Mid-single to low double-digit tiered royalties on future product sales • Option for U.S. profit sharing and co- promotion on up to two products arising from the collaboration Seagen* Deal Terms * Seagen is now part of Pfizer
7 Targeted Protein Degradation Harnessing the ubiquitin proteosome system to eliminate disease proteins Ubiquitin BTK Ubiquitination of Protein BTK Destroyed by the Proteasome Degrader recycling Cereblon E3 Ligase Complex BTK Poly Ubiquitinated Proteins E2 Nurix degrader drugs BTK NX-5948 MOA
A First-In-Class Franchise of BTK Degraders NX-5948 & NX-2127 – The big picture 8 BTK degraders can overcome treatment emergent resistance mutations BTK degraders have the potential to displace inhibitors BTK degraders may expand the market in other B-cell malignancies and autoimmune diseases NX-5948 TARGETED BTK DEGRADATION NX-2127 BTK DEGRADATION & IMMUNOMODULATION BTK degraders eliminate BTK scaffolding function
Blockbuster Opportunity in BTK Market $8.4 billion in annual sales 9 • Next generation BTK inhibitors are currently taking market share from Imbruvica • All BTK inhibitors share resistance mutation vulnerabilities • Opportunity for Nurix BTK degraders to displace both covalent and non- covalent inhibitors and expand the market 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 2016 2017 2018 2019 2020 2021 2022 BTK Yearly Sales Ibrutinib Acalabrutinib Zanubrutinib
1st Generation Covalent inhibitor Non-Covalent Inhibitors Next Generation Covalent inhibitors Degraders Evolution of BTK Targeted Therapies Resistance Is Futile Ibrutinib Zanubrutinib Acalabrutinib Pirtobrutinib NX-5948 NX-2127 10 Inhibitors share common resistance mutations
Nurix Degraders: 1) Eliminate the scaffolding function of BTK oncogenic signals 2) Are effective against resistance mutations through binding cooperativity between BTK and the ligase complex 11 BTK Degraders Disrupt BCR Signaling By Removal of the Protein and All of Its Functions Removal of BTK disrupts the signaling complex, effectively destroying the scaffolding function of the protein
12 NX-5948 Is More Potent and Broadly Active Than All BTK Inhibitors Tested • All inhibitors have resistance mutation liabilities • NX-5948 displays potent cell killing in the context of key resistance mutations • We have shown that BTK degradation translates into clinical responses across mutation classes WT C48 1S V41 6L T47 4I L5 28 W NX-5948 Ibrutinib Acalabrutinib Zanubrutinib Pirtobrutinib Vecabrutinib Fenebrutinib Nemtabrutinib GI-50 (nM) 0 1000 2000 3000 4000 5000 Most potent cell killing NX-5948 Demonstrates Broad Preclinical Activity 1st Generation Noncovalent Next Generation
B-Cell Malignancies Annual Incidence (U.S. & EU) Nurix BTK Degrader Franchise: Two BTK Degraders to Cover the Landscape of B-Cell Malignancies BTK, Bruton tyrosine kinase; DLBCL, Diffuse large B cell lymphoma; CLL, Chronic lymphocytic leukemia; MCL, Mantle cell lymphoma; WM, Waldenstrom's macroglobulinemia; MZL, Marginal zone lymphoma; FL, Follicular lymphoma; NHL, non-Hodgkin lymphoma 13Estimates based on 2020 incidence from DRG, GlobalData and secondary research; EU comprised of France, Germany, Italy, Spain and U.K. DLBCL FL MZL CLL WM NX-5948 NX-2127NX-2127 late line NX-5948 potential in combination 39,700 Chronic Lymphocytic Leukemia 6,300 Waldenstrom's macroglobulinemia 10,700 Marginal Zone Lymphoma 55,100 Diffused Large B-Cell Lymphoma 26,200 Follicular Lymphoma NX-2127 for aggressive NHL as monotherapy and in combination and potentially for late-line CLL NX-5948 for all lines of therapy in CLL and potentially NHL and WM as monotherapy and in combination Therapeutic goal: Expand role for BTK target therapy Therapeutic goal: Displace BTKi in indications where single-agent BTKi is standard of care and address BTKi resistance mutations MCL 6,200 Mantle cell lymphoma
NX-5948-301: Trial Design Phase 1a/b trial in adults with relapsed/refractory B-cell malignancies aSubtypes include: transformed indolent lymphoma (e.g., grade 3b/transformed FL), Richter-transformed DLBCL, high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements, high-grade B-cell lymphomas NOS; bIncludes patients with secondary CNS involvement; cAdditional lines of therapy include anthracycline for non-GCB DLBCL and BTKi for MCL Abbreviations: BCL-2i, B-cell lymphoma-2 inhibitor; BTKi, Bruton’s tyrosine kinase inhibitor; CIT, chemo-immunotherapy; CLL, chronic lymphocytic leukemia; CNS, central nervous system; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; GCB, germinal center B-cell; L, level; MCL, mantle cell lymphoma; LoT, line of therapy; MZL, marginal zone lymphoma; NOS, not otherwise specified; PCNSL, primary central nervous system lymphoma; SLL, small lymphocytic lymphoma; WM, Waldenströms macroglobulinemia Phase 1a dose escalation B-cell malignancies, including CLL (N = up to 30 patients) Potential Phase 1b dose expansiona (N = up to 80 patients) CLL/SLL (n=20) Prior BTKi and BCL-2i DLBCLb,c or MCLc (n=20) Prior anti-CD20 CIT + 1 LoTd FLc, MZLc, WMc (n=20) ≥2 prior LoT PCNSL (n=20) Who have progressed or had no response to ≥2 prior LoT Dose L1 50 mg QD Dose L2 100 mg QD Dose L3 200 mg QD Dose L4 300 mg QD (Starting dose) Dose L5 450 mg QD Dose L6+ 600 mg QD 14 NHL/WM dose-escalation level as of ASH 2023 update CLL dose-escalation level as of ASH 2023 update
Baseline Demographics and Disease Characteristics Heavily pretreated population Characteristics Patients with CLL (n=7) Patients with NHL/WM (n=19) Overall population (N=26) Median age, years (range) 64.0 (53–75) 63.0 (42–79) 63.5 (42–79) Male, n (%) Female, n (%) 5 (71.4) 2 (28.6) 13 (68.4) 6 (31.6) 18 (69.2) 8 (30.8) ECOG PS, n (%) 0 1 1 (14.3) 6 (85.7) 5 (26.3) 14 (73.7) 6 (23.1) 20 (76.9) Previous targeted treatmentsa, n (%) BTKi Pirtobrutinib BCL2i BTKi and BCL2i CAR-T therapy Bispecific antibody PI3Ki 7 (100.0) 1 (14.3) 6 (85.7) 6 (85.7) 0 (0.0) 0 (0.0) 2 (28.6) 10 (52.6) 2 (10.5) 3 (15.8) 3 (15.8) 7 (36.8) 5 (26.3) 2 (10.5) 17 (65.4) 3 (11.5) 9 (34.6) 9 (34.6) 7 (26.9) 5 (19.2) 4 (15.4) Median prior lines of therapy (range) 3.0 (2–5) 5.0 (2–10) 4.0 (2–10) Mutation statusb, n (%) BTK (T474) PLCG1/2c TP53 BCL2 (G101V and R107-R110dup) n=6 1 (16.7) 2 (33.3) 2 (33.3) 2 (33.3) n=15 0 (0.0) 2 (13.3) 3 (20.0) 0 (0.0) n=21 1 (4.8) 4 (19.0) 5 (23.8) 2 (9.5) aPatients could have received multiple prior treatments; bPatients could have multiple mutations, which were tested at baseline by central NGS (≥5% allelic frequency is reported); cPLCG1 (A902V); PLCG2 (K35R, V886A, V105I) 15Data cutoff: 17 Oct 2023
• No atrial fibrillation/flutter or hypertension • No DLTs and no TEAEs resulting in drug discontinuation • Four NX-5948-related grade ≥3 TEAEs (3 neutropenia, 1 thrombocytopenia); no related serious adverse events aPurpura/contusion includes episodes of contusion or purpura; bAggregate of ‘thrombocytopenia’ and ‘platelet count decreased’; cAggregate of neutrophil count decreased or neutropenia TEAEs, n (%) Any grade Grade ≥3 SAEs Purpura/contusiona 12 (46.2) – – Thrombocytopeniab 10 (38.5) 2 (7.7) – Neutropeniac 8 (30.8) 5 (19.2) – Anemia 6 (23.1) 1 (3.8) – Cough 5 (19.2) – – Headache 5 (19.2) – – Nausea 5 (19.2) – – Rash 4 (15.4) – – COVID-19 3 (11.5) 2 (7.7) 2 (7.7) Pneumonia 2 (7.7) 2 (7.7) 2 (7.7) 16 NX-5948 Was Well Tolerated Frequency of TEAEs in ≥15% of patients or grade ≥3 or SAEs in >1 patient, (n=26) Data cutoff: 17 Oct 2023
NX-5948 Was Well Tolerated Across Doses Tested Frequency of any grade TEAEs in ≥15% of patients TEAEs, n (%) 50 mg (n=7) 100 mg (n=6) 200 mg (n=6) 300 mg (n=4) 450 mg (n=3) All doses (N=26) Purpura/contusiona 5 (71.4) 2 (33.3) 1 (16.7) 2 (50.0) 2 (66.7) 12 (46.2) Thrombocytopeniab 2 (28.6) 3 (33.3) 2 (33.3) 3 (75.0) 1 (33.3) 10 (38.5) Neutropeniac 1 (14.3) 3 (50.0) 0 (0.0) 4 (100.0) 0 (0.0) 8 (30.8) Anemia 2 (28.6) 2 (33.3) 0 (0.0) 1 (25.0) 1 (33.3) 6 (23.1) Cough 0 (0.0) 2 (33.3) 1 (16.7) 2 (50.0) 0 (0.0) 5 (19.2) Headache 2 (28.6) 0 (0.0) 2 (33.0) 1 (25.0) 0 (0.0) 5 (19.2) Nausea 3 (42.9) 0 (0.0) 2 (33.3) 0 (0.0) 0 (0.0) 5 (19.2) Rash 2 (28.6) 2 (33.3) 0 (0.0) 0 (0.0) 0 (0.0) 4 (15.4) aPurpura/contusion includes episodes of contusion or purpura; bAggregate of ‘thrombocytopenia’ and ‘platelet count decreased’; cAggregate of neutrophil count decreased or neutropenia 17Data cutoff: 17 Oct 2023
NX-5948 Treatment Results in Rapid, Robust and Sustained BTK Degradation Dose Number of patients per day (mg) Day 1 Day 2 Day 8 Day 15 Day 22 Day 29 50 7 7 7 6 5 6 100 6 6 5 6 6 5 200 6 6 6 6 4 3 300 4 4 4 4 4 2 BTK, Bruton’s tyrosine kinase; MFI, mean fluorescence intensity; SEM, standard error of the mean A) NX-5948 C1D1 pharmacokinetics 0 4 8 1 2 1 6 2 0 2 4 0 1 0 2 0 3 0 4 0 5 0 Time (hours) N X- 59 48 m ea n (± SE M ) pl as m a co nc en tra tio n (n g/ m L) 50 mg (n=7) 100 mg (n=6) 200 mg (n=6) 300 mg (n=4) 0 2000 4000 6000 8000 10000 12000 BT K M FI (b ac kg ro un d su bt ra ct ed ) m ea n (± SE M ) 50 mg 100 mg 200 mg Day 2 Day 15 Day 22 Day 29Day 8 300 mg aBTK measured in patient B-cells whole blood using flow cytometry assay B) BTKa degradation in patients receiving NX-5948 18Data cutoff: 17 Oct 2023
Broad Antitumor Activity in CLL as Demonstrated by Significant Lymph Node Reduction and Objective Response Rate 19 • 6/7 patients showed clinical benefit (3 PRs all ongoing, 3 SD with 2 ongoing) • All patients had evidence of lymph node reduction CLL disease-evaluable patientsa n=7 Objective response rateb, % (95% CI) 42.9 (9.9–81.6) Best response, n (%) CR 0 (0.0) PR 3 (42.9) SD 3 (42.9) PD 1 (14.3) aPatients without identified target lesion(s) at baseline are evaluated as disease-evaluable per iwCLL, while they may not be represented in waterfall plot; bObjective response rate includes CR + CRi + nPR + PR-L + PR Treatment Ongoing 80 60 40 20 0 –20 –40 –60 –80 Pe rc en t C ha ng e in L ym ph N od e Si ze M ax im um P er ce nt C ha ng e fr om B as el in e in S um o f P ro du ct D ia m et er s CI, confidence interval; CLL, chronic lymphocytic leukemia; CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease Data cutoff: 17 Oct 2023
Responses Are Durable and Treatment Ongoing in Patients with CLL Data cutoff: 17 Oct 2023 20 CLL, chronic lymphocytic leukemia NX-5948: Time on study for patients with CLL * * Patient enrolled with CLL subsequently confirmed to have Richter’s transformation to Hodgkin's disease
0 20 40 60 80 260 -80 -60 -40 -20 M ax im um P er ce nt C ha ng e fro m B as el in e in S um o f P ro du ct D ia m et er s Assigned Dose (mg)Treatment Ongoing 50 100 200 300 MCL DLBCL PCNSL MCL MCL MZL DLBCL FL MCL MZL DLBCL Responses to NX-5948 Observed Across NHL Subtypes NHL/WM disease-evaluable patientsa n=14 Best response, n (%) CR 0 (0.0) PR/PMR 3 (21.4) SD 3 (21.4) PD 8 (57.1) aPatients without identified target lesion(s) at baseline are evaluated as disease-evaluable per Lugano and WM, while they may not be represented in waterfall plot 21 Activity observed across NHL subtypes CR, complete response; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; NHL, non-Hodgkin’s lymphoma; PCNSL, primary CNS lymphoma; PD, progressive disease; PR, partial response; SD, stable disease; WM, Waldenstrom’s macroglobulinemia Data cutoff: 17 Oct 2023
Durable Responses in Patients with NHL Data cutoff: 17 Oct 2023 22 NX-5948: Time on study for patients with NHL DLBCL, diffuse large B cell lymphoma; FL, Follicular lymphoma; MCL, Mantle cell lymphoma; MZL, Marginal zone lymphoma; NHL, non- Hodgkin’s lymphoma; PCNSL, primary CNS lymphoma; PD, progressive disease; PR, partial response; PMR, partial metabolic response; SD, stable disease; SLL, small lymphocytic lymphoma; WM, Waldenstrom's macroglobulinemia
23 Vision: Prioritizing NX-5948 in CLL and Enabling Broad Strategy in NHL • Accelerating enrollment in dose escalation to identify Phase 1b expansion dose levels for CLL and NHL with expansion planned for early 2024 Enable potential accelerated approval(s) in r/r CLL/MCL/WM Enable combinations for earlier line trials 2L+ CLL Superiority post BTKi +/- BCL-2i failure 1L CLL Displace BTKi r/r MCL Superiority to BTKi 1L MCL Displace or improve SOC B-cell malignancies Phase 1 & 2 CLL Phase 3 MCL Phase 3 1L DLBCL Improve SOC DLBCL Phase 3
24 Beyond Hem/Onc: NX-5948 Is Highly Effective in Models of Major Inflammation & Immunology Indications 0 5 10 15 0 1 2 3 4 Rheumatoid Arthritis Model Days C lin ic al A rth rit is S co re * *** ******** Tx *p<0.05, **p < 0.01, ***, p < 0.001, ****p < 0.0001 compared to vehicle control Source: Rountree et al., 3rd B&T-cell Summit 2022 10 15 20 0 1 2 3 Multiple Sclerosis Model Days EA E Se ve rit y Sc or e **** Vehicle NX-5948 10 mg/kg NX-5948 30 mg/kg Ibrutinib 10 mg/kg Ibrutinib 30 mg/kg FTY720 3 mg/kg Plans to enable initiation of I&I development Extended preclinical toxicology Healthy volunteer study NX-5948 in Inflammation & Immunology
Oral daily dosing Phase 1a Accelerated titration / 3+3 escalation (n∼60a) CLL/SLL, MCL, DLBCL, FL, MZL, WM Phase 1b Select cohort expansionb CLL/SLL (100 mg) (n=40) MCL (300 mg) (n=20) DLBCL, WM (300 mg) (n=20)50 mg 100 mg 200 mg 300 mg CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; DLT, dose-limiting toxicity; FL, follicular lymphoma; MCL, mantle cell lymphoma; MTD, maximum tolerated dose; MZL, marginal zone lymphoma; PD, pharmacodynamics; PK, pharmacokinetics; PCNSL, primary central nervous system lymphoma; SLL, small lymphocytic lymphoma; WM, Waldenstrom's macroglobulinemia aPlanned number of evaluable patients (i.e., meeting DLT evaluability criteria); bPlanned number of evaluable patients (i.e., meeting efficacy evaluability criteria) • NX-2127-001 is a first-in- human, multicenter, U.S.- based, open-label, Phase 1 dose-escalation (Phase 1a) and cohort-expansion (Phase 1b) trial • Study is evaluating NX-2127 in adults with relapsed/refractory B-cell malignancies • Other potential expansion cohorts include patients with FL, MZL and PCNSL NX-2127-001: Trial Design Phase 1a/b trial in adults with relapsed/refractory B-cell malignancies 150 mg 25 Expansion dose for MCL & DLBCL Expansion dose for CLL
Baseline Demographics and Disease Characteristics Heavily pretreated population with significant acquired resistance mutations Characteristic CLL/SLL (n=33) NHL/WM (n=21) Overall population (N=54) Median age, years (range) 74.0 (58.0–90.0) 70.0 (50.0–92.0) 72.5 (50.0–92.0) Female, n (%) Male, n (%) 11 (33.3) 22 (66.7) 6 (28.6) 15 (71.4) 17 (31.5) 37 (68.5) ECOG PS, n (%) 0 1 18 (54.5) 15 (45.5) 10 (47.6) 11 (52.4) 28 (51.9) 26 (48.1) No. of lines of prior therapya, median (range) BTKi, n (%) Pirtobrutinib, n (%) BTKi and BCL2i, n (%) cBTKi, ncBTKi, and BCL2i, n (%) CAR-T/-NK therapy, n (%) Bispecific antibody, n (%) Immunomodulatory therapy (lenalidomide), n (%) 5 (2–11) 33 (100.0) 9 (27.3) 26 (78.8) 8 (24.2) 1 (3.0) 0 (0.0) 4 (12.1) 4 (2–10) 15 (71.4) 5 (23.8) 1 (4.8) 0 (0.0) 3 (14.3) 2 (9.5) 4 (19.0) 4 (2–11) 48 (88.9) 14 (25.9) 27 (50.0) 8 (14.8) 4 (7.4) 2 (3.7) 8 (14.8) aPatients could have multiple prior treatments 26Data cutoff: 15 Sept 2023
Baseline Demographics and Disease Characteristics (Cont’d) Heavily pretreated population with significant acquired resistance mutations aPatients could have multiple BTK mutations; mutations were tested centrally at baseline by next-generation sequencing (allelic frequency ≥5% is reported) bL845F, D334H, D1140N, T961M, S707F Mutationa CLL/SLL (n=33) NHL/WM (n=21) Overall population (N=54) BTK, n (%) C481S or C481R L528W T474F or T474I V416L L512V 12 (36.4) 7 (21.2) 4 (12.1) 4 (12.1) 1 (3.0) 0 (0.0) 3 (14.3) 1 (4.8) 1 (4.8) 1 (4.8) 0 (0.0) 1 (4.8) 15 (27.8) 8 (14.8) 5 (9.3) 5 (9.3) 1 (1.9) 1 (1.9) PLCG2b 1 (3.0) 2 (9.5) 3 (5.6) BCL2 (G101V) 4 (12.1) 0 (0.0) 4 (7.4) 27Data cutoff: 15 Sept 2023
Safety Profile Manageable With Decreasing Incidence of Atrial Fibrillation Frequency of TEAEs in ≥20% of patients or grade ≥3 or SAEs in >1 patient, (n=54) aAggregate of ‘neutropenia’ and ‘neutrophil count decreased’; bBruising/contusion includes episodes coded as contusion; cAggregate of ‘thrombocytopenia’ and ‘platelet count decreased’; dIncludes one Grade 5 event; eAggregate of 'atrial fibrillation' and 'atrial flutter’; fIncludes two Grade 5 events Treatment emergent adverse events (TEAEs), n (%) Any grade Grade ≥3 SAEs Fatigue 25 (46.3) – – Neutropeniaa 25 (46.3) 23 (42.6) – Hypertension 18 (33.3) 8 (14.8) – Bruising/contusionb 16 (29.6) – 1 (1.9) Diarrhea 16 (29.6) – – Anemia 13 (24.1) 8 (14.8) 1 (1.9) Dizziness 13 (24.1) – – Dyspnea 13 (24.1) 1 (1.9) – Thrombocytopeniac 13 (24.1) 4 (7.4) – Constipation 12 (22.2) – – Headache 11 (20.4) – – Upper GI hemorrhaged 2 (3.7) 2 (3.7) 2 (3.7) Pruritus 11 (20.4) 1 (1.9) – COVID-19 7 (13.0) 4 (7.4) 3 (5.6) Atrial fibrillatione 6 (11.1) 3 (5.6) 3 (5.6) Pneumonia 6 (11.1) 3 (5.6) 3 (5.6) Pain in extremity 5 (9.3) 2 (3.7) 1 (1.9) Leukocytosis 3 (5.6) 3 (5.6) – Lymphocyte count increased 2 (3.7) 2 (3.7) – Sepsis f 2 (3.7) 2 (3.7) 2 (3.7) 2 DLTs have been reported: cognitive disturbance (300 mg DL) and neutropenia (300 mg DL) 28 • No new cases since ASH 2022 • Incidence decreased from 17% to 11% Data cutoff: 15 Sept 2023
B) BTKa degradation in patients receiving NX-2127A) NX-2127 C1D1 pharmacokinetics C) Ikarosb degradation in patients receiving NX-2127 NX-2127 Treatment Results in Rapid, Robust and Sustained BTK Degradation With Clinically Relevant Ikaros Degradation Dose (mg) Number of patients per day Day 0 Day 2 Day 8 Day 15 Day 22 Day 29 100 28 27 24 23 22 20 150 4 4 4 3 2 2 200 9 9 8 9 7 6 300 10 10 8 9 6* 4 aBTK measured in patient B-cells whole blood using flow cytometry assay; bIkaros measured in patient T-cells in PBMC using flow cytometry assay; c1 patient had dose modification from Day 19 onwards Dose (mg) Number of patients per day Day 0 Day 8 Day 29 100 23 19 16 200 5 5 4 300 5 4 3c 0 10 20 30 0 25 50 75 100 0 10 20 30 0 25 50 75 100 100 mg 200 mg 300 mg 0 10 20 30 0 25 50 75 100 T ce ll Ik ar os (% R em ai n) R el at iv e to C yc le 1 D ay 1 Time (days) 0 2 0 0 0 4 0 0 0 6 0 0 0 8 0 0 0 1 0 0 0 0 1 2 0 0 0 T i m e ( d a y s ) BT K M FI (b ac kg ro un d su bt ra ct ed ) m ea n (± SE M ) 2 8 15 22 29 200 mg 300 mg 100 mg 150 mg 0 4 8 1 2 1 6 2 0 2 4 0 5 1 0 1 5 2 0 T i m e ( h o u r s ) N X -2 12 7 m ea n (± S E M ) pl as m a co nc en tr at io n (n g/ m L) 100 mg (n=28) 150 mg (n=4) 200 mg (n=10) 300 mg (n=11) 29Data cutoff: 15 Sept 2023
Broad Antitumor Activity in CLL/SLL as Demonstrated by Significant Lymph Node Reduction and Objective Response Rate CI, confidence interval; CLL, chronic lymphocytic leukemia; CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease; SLL, small lymphocytic leukemia; SPD, sum of product diameters 30 BTK Mutation Treatment Ongoing Patient with SLL * □ * * ** □ **** * * M ax im um p er ce nt ag e ch an ge fr om b as el in e in S PD CLL/SLL disease-evaluable patientsa n=27 Objective response rateb, % (95% CI) 40.7 (22.4–61.2) Best response, n (%) CR 0 (0.0) PR / PR-L 11 (40.7) SD 12 (44.4) PD 4 (14.8) 80 60 40 20 0 –20 –40 –60 –80 –100 aPatients without identified target lesion(s) at baseline are evaluated as disease-evaluable per iwCLL7, while they may not be represented in waterfall plot; bObjective response rate includes CR + CRi + nPR + PR-L + PR Objective response rate in heavily pretreated population was 41% with treatment ongoing in 13 patients, up from 33% reported at ASH 2022 Pe rc en t C ha ng e in L ym ph N od e Si ze Patient with SLL Data cutoff: 15 Sept 2023
Durable Responses Seen in Heavily Pretreated CLL/SLL Patients 31 NX-2127 Time on study for CLL/SLL subjects * * * * * * * ** * * *□ BTK Mutation Treatment Ongoing Patient with SLL * □ Assigned Dose (mg) Response 100 150 200 300 PR PR-L SD PD NX-2127: Time on study for patients with CLL/SLL 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Cycle (28 days) All patients had prior cBTKi Double exposed: Prior cBTKi and BCL2i Triple exposed: Prior cBTKi, ncBTKi, and BCL2i BCL2i, B-cell lymphoma-2 inhibitor; BTK, Bruton’s tyrosine kinase; cBTKi, covalent BTK inhibitor; ncBTKi, non- covalent BTK inhibitor; PD, progressive disease; Pirto, pirtobrunib; PR, partial response; PR-L, partial response with lymphocytosis; SD, stable disease Mutations were tested at baseline by NGS centrally Data cutoff: 15 Sept 2023
Responses Observed Across NHL Subtypes Including Rapid and Sustained Complete Responses CR, complete response; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; NHL, non-Hodgkin’s lymphoma; PD, progressive disease; PR, partial response; SD, stable disease; WM, Waldenstrom’s macroglobulinemia 0 20 40 60 80 440 -80 -60 -40 -20 -100 Disease Type OngoingDLBCL FL MCL MZL WM SD SD PD PD PD PD SD SD CR CR PR PR M ax im um p er ce nt ag e ch an ge fr om b as el in e in S PD NHL/WM disease-evaluable patientsa n=17 Best response, n (%) CR 2 (11.8) PR 2 (11.8) SD 5 (29.4) PD 8 (47.1) aPatients without identified target lesion(s) at baseline are evaluated as disease- evaluable per Lugano and WM, while they may not be represented in waterfall plot 32 • Rapid CR at 8 weeks observed in 2 patients (DLBCL, MCL) with 15+ months durability • Rapid PRs at 8 weeks were observed in 2 patients (FL, MZL) Pe rc en t C ha ng e in L ym ph N od e Si ze Data cutoff: 15 Sept 2023
Ongoing Durable Complete Responses With Over One Year of Follow Up Seen in DLBCL and MCL 33BTKi, Bruton’s tyrosine kinase inhibitor; CR, complete response; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; PD, progressive disease; PR, partial response; SD, stable disease; WM, Waldenstrom’s macroglobulinemia NX-2127 Time on study for CLL/SLL subjects Cycle (28 days) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 NX-2127: Time on study for patients with NHL MCL MCL MCL MCL MCL MCL MCL DLBCL DLBCL DLBCL DLBCL DLBCL DLBCL WM WM WM FL FL MZL MZL MZL Data cutoff: 15 Sept 2023
Rapid and Sustained Complete Response in Relapsed/Refractory DLBCL With NX-2127 34 Confirmatory Week 16 Scan Deauville score: 2 Baseline FDG-PET CT Scan Disease Assessment Deauville score: 5 Bladder Bladder • 84-year-old woman with multiply relapsed ABC- DLBCL following 4 lines of aggressive therapy (including combination of rituximab, ibrutinib, and lenalidomide) • Complete response on first assessment at week 8, confirmed at week 16 • As of September 15, 2023, this patient remains in complete response and on treatment with over 15 months of follow up
Rapid and Sustained Complete Response in Relapsed/Refractory MCL With NX-2127 35 Week 8 Scan Deauville score: 2 Baseline FDG-PET CT Scan Disease Assessment Deauville score: 5 Bladder Bladder • 64-year-old woman with multiply relapsed MCL, following stem cell transplant, chemo- immunotherapy, and ibrutinib • Complete response on first assessment at week 8, confirmed at week 16 • As of September 15, 2023, this patient remains in complete response having come off therapy by choice after 17 cycles of treatment
36 Vision: Focused Strategy With NX-2127 in NHL Initiation of advanced development activities are dependent on threshold activity in Phase 1b and emerging data for NX-5948 Establish ORR and CR rate in DLBCL and MCL Enable combinations for earlier line trials r/r DLBCL Potential monotherapy 1L DLBCL Improve SOC r/r MCL Potential monotherapy B-cell malignancies Phase 1 & 2 DLBCL Phase 3 MCL Phase 3
Targeting CBL-B Enhances Antitumor Response A Master Orchestrator of the Immune System 37 CBL-B TumorDCDying tumor Lymph node T cell Blood Tumor Dying tumor T cell NK cell CBL-B inhibition increases: • DC and NK infiltration and function • T cell priming • Cytotoxic T cells function • Ability of T cells to resist tumor immunosuppressive mechanisms: Treg, MDSC, and TGF-β CBL-B mediated mechanisms strongly restrains a productive anti-tumor response
NX-1607 Mechanism of Action: Intramolecular Glue TKB RING Y363 Closed State INACTIVE TKB Y363 E2 TKB pY363 E2 Substrate protein 1. Kinase Phosphorylation locks CBL-B in the ACTIVE Conformation p 2. E2/substrate NX-1607 acts as an intramolecular glue forcing CBL-B in its folded INACTIVE state TKB RING NX-1607 Opened State Immune Response Immune Response 38
39 Single-Agent NX-1607 Induces Antitumor Response in Multiple Models NX-1607 Prolonged Survival NX-1607 Reduced Tumor Volume NX-1607 Reduced Tumor Volume NX-1607 30 mg/kg day 7 to 46 NX-1607 30 mg/kg day 16 to 28 Colorectal Triple-Negative Breast B Cell Lymphoma Shaded area indicates dosing period 0 25 50 75 100 125 150 0 25 50 75 100 Days post implant % S ur vi va l Vehicle NX-1607 <0.0001p= 20 25 30 0 200 400 600 800 1000 1200 1400 Days post implant Tu m or V ol um e (m m 3 ) NX-1607 Vehicle p<0.0001
NX-1607 and Anti-PD-1 Synergize to Enhance Anti-Tumor Effects and Survival of Mice in Multiple Tumor Models Colorectal (CT26) Triple-Negative Breast (4T1) Shaded area indicates dosing period: NX-1607 (30 mg/kg, PO daily) and anti-PD-1 twice a week at 10 mg/kg dosing period Colorectal (MC38) 40 Vehicle NX-1607 anti-PD-1 NX-1607+anti-PD-1 0 100 200 5000 10000 15000 Day 28 4T1 Lung Metastases # M et as ta tic C ol on ie s p<0.01 p<0.01
NX-1607-101: Phase 1 First-in-Human Clinical Trial Design Phase 1 trial testing both monotherapy and combination with paclitaxel in relapsed or refractory tumors Dose Escalation Potential Cohort Expansion Melanoma Platinum Resistant Epithelial Ovarian Cancer (EOC) Gastric Cancer Squamous Cell Carcinoma of the Head and Neck (HNSCC) Non-small Cell Lung Cancer (NSCLC) Objectives: • Assess safety and tolerability • Identify maximum tolerated dose • Evaluate PK/PD including proprietary biomarkers Oral daily dosing Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Metastatic Castration Resistant Prostate Cancer (mCRPC) Mixed Solid Tumor Cohort Diffuse Large B-cell Lymphoma (DLBCL) Checkpoint resistant tumors Immunosuppressive microenvironment Poorly immunogenic tumors 41
42 NX-5948 NX-1607 Research pipeline Note: All anticipated timing is based on calendar-year periods • Present updated Phase 1a clinical data supporting Phase 1b dose expansion • Accelerate Phase 1 enrollment to enable pivotal trials • Complete IND-enabling studies for autoimmune indications • Present Phase 1a monotherapy and paclitaxel combination data • Define Phase 1b dose(s) for cohort expansion • Nominate new targeted protein degrader development candidate • Achieve substantial research collaboration milestones throughout 2024 Defining Success in 2024 B-cell malignancies Immune oncology Platform & pipeline NX-2127 • Resolve partial clinical hold to enable the introduction of new drug product into the ongoing Phase 1 clinical trial
Strong Financial Position $329M includes funds as of August 31, 2023, and $60M from Pfizer deal R&D collaboration cashflow: • Gilead: $45M upfront and $67M in licensing fee and milestone payments earned to date • Sanofi: $77M upfront and $7M in milestone payments earned to date • Seagen (now part of Pfizer): $60M upfront payment • $409 million generated through discovery partnership payments • Based on our current operating plan, Nurix has cash runway into the second half of 2025 43 Nurix retains option for U.S. profit share and co-promotion for six drug candidates across three partnerships0 50 100 150 200 250 300 350 400 450 Pre-2019 2019 2020 2021 2022 2023 YTD N on - D ilu tiv e Fu nd in g (m ill io ns ) Cummulative Partnership Capital Upfronts Milestones & Licensing
Thank you
Exhibit 99.2
[Nurix logo]
Nurix Therapeutics Outlines 2024 Strategic Priorities with Advancement of Targeted Protein Modulation Pipeline in Cancer and Autoimmune Diseases
Positive Phase 1 data presented at American Society of Hematology supports prioritizing the acceleration of enrollment of NX-5948 in leukemia and lymphoma
Strategic collaborations in small molecule, targeted protein degradation with Gilead and Sanofi, and degrader antibody conjugates with Pfizer generate significant non-dilutive cash flow and build future pipeline
Nurix plans to expand therapeutic area focus in autoimmune and inflammatory diseases
San Francisco, CA, January 8, 2024 — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today outlined key objectives and anticipated milestones for 2024 and provided an overview of recent progress in a presentation at the 42nd Annual J.P. Morgan Healthcare Conference.
“In 2023, Nurix strengthened its leadership position in the targeted protein modulation field with significant accomplishments in several key areas of our business,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “We recently presented impressive clinical responses from our NX-5948 clinical trial in leukemia and lymphomas and have implemented plans to accelerate enrollment with dozens of new clinical trial sites in the United States, the United Kingdom, and Europe in 2024. We expanded our pipeline through strategic collaborations, including the addition of a new class of medicines with our first of its kind collaboration with Seagen, now Pfizer, to develop Degrader-Antibody Conjugates for use in cancer. We also made substantial progress in our existing collaborations, as exemplified by Gilead exercising its option to exclusively license Nurix’s investigational targeted IRAK4 protein degrader molecule for rheumatoid arthritis and other inflammatory diseases. Notably, our strategic collaborations generated meaningful non-dilutive funding in 2023, which positions us well financially to progress and expand our pipeline through important milestones in 2024 and beyond.”
2023 Accomplishments and Business Highlights
Clinical Stage Pipeline
•Advanced our wholly owned Bruton’s tyrosine kinase (BTK) degrader programs and presented positive clinical data at oncology-focused medical meetings throughout 2023. Most recently, positive data were presented from Nurix’s novel BTK degrader programs, NX-5948 and NX-2127, at the 65th American Society of Hematology (ASH) Annual Meeting. A webcast of Nurix’s ASH presentation is available in the Investors section of the Nurix website under Events and Presentations.
oNX-5948: is an orally bioavailable degrader of BTK. Nurix is evaluating daily oral dosing of NX-5948 in a Phase 1a/1b clinical trial in patients with relapsed or refractory B-cell malignancies. At the ASH meeting, Nurix reported data from the dose escalation stage of the trial demonstrating dose-dependent pharmacokinetics
(PK), resulting in rapid, robust, and sustained BTK degradation in all patients treated. NX-5948 was well-tolerated across all doses tested from 50 to 450 mg daily. Preliminary efficacy data demonstrated clinical benefit in six of seven patients with chronic lymphocytic leukemia (CLL) at doses ranging from 50 to 200 mg. In non-Hodgkin lymphoma (NHL) patients treated with doses from 50 to 450 mg, durable responses were seen across indications with almost half the patients continuing to receive treatment as of the data cut-off date. Dose escalation in the NX-5948 trial continues across all indications and the study is actively enrolling patients in the United States, the United Kingdom, and the Netherlands. Additional information on the ongoing clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
oNX-2127: is a novel orally bioavailable bifunctional molecule that degrades BTK and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). At the ASH meeting, Nurix reported data from its Phase 1a dose escalation and Phase 1b dose expansion cohorts in CLL, mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL). NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of Ikaros. Treatment with NX-2127 resulted in encouraging rapid and durable responses in the heavily pre-treated patient population including patients with BTK inhibitor resistance mutations. Durable complete responses (CR) were reported in two patients with MCL and DLBCL which remained ongoing for over one year. In patients with CLL, the data demonstrated an improved overall response rate (ORR) of 41% compared to 33% ORR presented at ASH 2022. NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
•Expanded Phase 1a dose escalation trial of NX-1607 to include a combination therapy arm with Paclitaxel. Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B) for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing Phase 1a dose escalation trial in monotherapy and in a combination cohort with paclitaxel in adults in a range of oncology indications at multiple clinical sites in the United Kingdom and United States. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
Research and Corporate
•Advanced internal and collaboration preclinical pipeline from productive DELigase drug discovery platform
oEntered into a strategic collaboration with Seagen (now part of Pfizer) to develop a portfolio of Degrader-Antibody Conjugates (DACs). DACs are antibodies that deliver a targeted protein degrader payload to selectively kill cancer cells. Nurix received a $60 million upfront payment and has the potential to receive approximately $3.4 billion in milestone payments plus future royalties. Nurix also retains an option for U.S. profit sharing and co-promotion on two products arising from the collaboration.
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oAdvanced Sanofi and Gilead collaborations and achieved major milestone in Gilead collaboration with the licensing of NX-0479, an oral IRAK4 degrader. Nurix advanced its ongoing strategic collaborations with both Sanofi and Gilead, earning $74 million in preclinical milestones and licensing fees through fiscal Q3 2023. In March, Gilead exercised its option to exclusively license Nurix’s oral IRAK4 degrader, which has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases. GS-6791/NX-0479 is the first development candidate resulting from the 2019 Nurix-Gilead collaboration to discover, develop and commercialize a pipeline of innovative targeted protein degradation therapies. Nurix received a $20 million license fee and could potentially receive up to an additional $425 million in clinical, regulatory and commercial milestone payments, as well as up to low double-digit tiered royalties on product net sales.
•Maintained strong balance sheet with $329M including funds as of August 31, 2023 and $60 million upfront received from Seagen (now part of Pfizer) in the fourth quarter of 2023. Based on our current operating plan Nurix has cash runway into the second half of 2025.
2024 Goals and Catalysts
•Clinical updates to Nurix’s three wholly clinical stage programs as described below:
oNX-5948: Nurix is evaluating NX-5948 in an ongoing Phase 1 clinical trial in adults with relapsed or refractory B cell malignancies and expects to define doses for Phase 1b cohort expansion in CLL and NHL and to present additional clinical data with higher dose levels and longer treatment duration. The company plans to accelerate Phase 1 clinical trial enrollment to enable pivotal trials. In addition, Nurix expects to complete ongoing preclinical studies that can enable an investigational new drug (IND) application for NX-5948 in autoimmune indications.
oNX-2127: Nurix expects to resolve the partial clinical hold on the Phase 1 clinical trial to enable the introduction of newly manufactured drug product into the ongoing Phase 1 clinical trial.
oNX-1607: Nurix expects to present data from the Phase 1a stage of the monotherapy and paclitaxel combination cohorts in its clinical trial of NX-1607 in a range of oncology indications, and to define plans and dose(s) for Phase 1b cohort expansion.
Research and Corporate
•Nurix expects to nominate a new targeted protein degrader development candidate.
•Nurix plans to present and publish preclinical work on its wholly owned programs throughout 2024 at appropriate scientific and medical meetings.
•Research milestones: Nurix expects to achieve multiple research collaboration milestones throughout 2024 from its existing collaborations with Gilead, Sanofi, and Pfizer.
•Business Development: Nurix will continue to prioritize the formation of new drug discovery and development collaborations to further advance and fund its pipeline.
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About Nurix
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases including inflammatory conditions. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com.
Forward Looking Statements
This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,” and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix’s expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding: Nurix’s future plans, prospects and strategies, including its plans to expand into therapeutics areas such as autoimmune and inflammatory disease, its plans to accelerate enrollment in the NX-5948 clinical trials, and its plans to pursue an IND application for NX-5948 in autoimmune indications; Nurix’s future financial or business performance; Nurix’s current and prospective drug candidates; the planned timing and conduct of the clinical trials for Nurix’s drug candidates; the planned timing for the provision of updates and findings from Nurix’s preclinical and clinical studies; the tolerability, safety profile, therapeutic potential and other advantages of Nurix’s drug candidates; the therapeutic potential of Degrader-Antibody Conjugates; the potential benefits of Nurix’s collaborations, including potential milestone and sales-related payments; the extent to which Nurix’s scientific approach, Nurix’s DELigase™ platform and Degrader-Antibody Conjugates may potentially address a broad range of diseases; and Nurix’s ability to fund it operating activities into the second quarter of 2025. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions regarding the future of Nurix’s business, its future plans and strategies, its preclinical and clinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix’s actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and
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uncertainties include, but are not limited to: (i) risks and uncertainties related to Nurix’s ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates, including the risk that Nurix may not be able to adequately address the FDA’s concerns with respect to the NX-2127 clinical trial; (ii) risks and uncertainties related to the timing and results of preclinical studies and clinical trials; (iii) risks and uncertainties related to Nurix’s ability to fund development activities and achieve development goals; (iv) uncertainties related to the timing and receipt of payments from Nurix’s collaboration partners, including milestone payments and royalties on future potential product sales; (v) the impact of macroeconomic conditions and global or regional events on Nurix’s business, clinical trials, financial condition, liquidity and results of operations; (vi) risks and uncertainties related to Nurix’s ability to protect intellectual property and (vii) other risks and uncertainties described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the fiscal quarter ended August 31, 2023, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.
Contacts:
Investors
Silinda Neou
Nurix Therapeutics
ir@nurixtx.com
Elizabeth Wolffe, Ph.D.
Wheelhouse Life Science Advisors
lwolffe@wheelhouselsa.com
Media
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
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