SEC Form DEFA14A filed by Coherus BioSciences Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
(Amendment No. )
Filed by the Registrant x
Filed by a party other than the Registrant ¨
Check the appropriate box:
¨ | Preliminary Proxy Statement |
| |
¨ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
| |
¨ | Definitive Proxy Statement |
| |
¨ | Definitive Additional Materials |
| |
x | Soliciting Material under §240.14a-12 |
Coherus BioSciences, Inc.
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement, if Other Than The Registrant)
Payment of Filing Fee (Check the appropriate box):
x | No fee required. |
| |
¨ | Fee paid previously with preliminary materials. |
| |
¨ | Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11. |
43rd Annual J.P. Morgan Healthcare Conference January 2025
Forward Looking Statements 2 ©2025 Coherus BioSciences Except for the historical information contained herein, the matters set forth in this presentation are forward - looking statement s within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements about the agreement to sell Coheru s’ UDENYCA franchise to Intas Pharmaceuticals Ltd. and related matters, including, but not limited to, the ability to satisfy the closing conditions to consummate the proposed tran sac tion at all or in the estimated time; prospective performance and opportunities with respect to Coherus or the UDENYCA franchise; post - closing operations and the outlook for Cohe rus or the UDENYCA franchise; the Company’s targets, plans, objectives or goals for future operations, including those related to the UDENYCA franchise, product candidat es, research and development, and product candidate approvals; future receipt of sales milestone payments from the proposed transaction to sell the UDENYCA franchise; projection s o f reductions in future indebtedness; projections of Coherus’ cash runway in the future; statements about the potential uses of proceeds from the transaction to sell the UDENYCA fra nchise, statements about future clinical events, catalysts and data readouts, statements about growth in sales or revenues and Coherus’ future balance sheet, estimates of mar ket opportunity, market value and treatable patients or cases, statements about sales or revenue ramp, statements about expected 2024 total year and Q4 2024 expected net revenues an d s ales, and expected 2024 year - end cash, cash equivalents and investments, and the assumptions underlying or relating to such statements. Such forward - looking statements invo lve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or ac hie vements expressed or implied by the forward - looking statements. Such risks and uncertainties include, among others, uncertainties as to the timing for completion of the proposed tr ansaction to sell the UDENYCA franchise; uncertainties as to the Company’s ability to obtain the approval of its shareholders required to consummate the proposed transaction to sel l t he UDENYCA franchise; the possibility that competing offers will be made by third parties; uncertainties of receipt of sales milestone payments in the future; the occurrence of a ny event, change or other circumstance that may give rise to a right of one or both of parties to terminate the asset purchase agreement; the possibility that the proposed transaction to se ll the UDENYCA franchise may not be completed in the time frame expected by the Company or at all, including due to the possibility that a governmental entity may prohibit, delay , o r refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations); the risk that th e proposed transaction disrupts the Company’s current plans and operations or diverts the attention of the Company’s management or employees from ongoing business operations; the ris k that the Company may not realize the anticipated benefits of the proposed transaction to sell the UDENYCA franchise in the time frame expected, or at all; the eff ect s of the proposed transaction on relationships with the Company’s employees, suppliers, business or collaboration partners or governmental entities, or other third parties as a resu lt of the proposed transaction; the ability to retain and hire key personnel; significant or unexpected costs, charges or expenses resulting from the proposed transaction; the risks and u nce rtainties inherent with clinical research and commercialization; the risks and uncertainties of the clinical development and regulatory approval process, including the tim ing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions; risks and uncertainties in executing collaboration agreements and other joint ven tur es, including particular risks of working with international partners; and the risks and uncertainties of litigation. For a further discussion of these and other factors th at could cause the Company’s future results to differ materially from any forward - looking statements see the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10 - Q for t he period ended September 30, 2024, filed with the SEC on November 6, 2024, as updated by the Company’s subsequent periodic reports filed with the SEC and, when available, the pro xy statement of the Company relating to the proposed transaction to sell the UDENYCA franchise. Any forward - looking statements speak only as of the date of this presentatio n and are made based on the current good faith beliefs and judgments of the Company’s management, and the reader is cautioned not to rely on any forward - looking statements mad e by the Company. Unless required by law, the Company is not under any duty and undertakes no obligation to publicly update or revise any forward - looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes. UDENYCA®, UDENYCA® ONBODY , and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, un les s otherwise noted. Trademarks and trade names of other companies appearing in this presentation are, to the knowledge of Coherus, the property of their respective owners.
Forward Looking Statements 3 ©2025 Coherus BioSciences Additional Information and Where to Find It In connection with the proposed transaction, the Company expects to file with the SEC a proxy statement on Schedule 14A, and it may also file other documents regarding the proposed transaction with the SEC. Promptly after filing its definitive proxy statement with the SEC, the Company will mail t he definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY THE PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSE D TRANSACTION, RELATED MATTERS AND THE PARTIES TO THE PROPOSED TRANSACTION. You may obtain a free copy of the proxy statement and other relevant documents (if and when they become available) that are o r w ill be filed with the SEC for free at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on t he Company’s website at https://investors.coherus.com/sec - filings or by contacting the Company’s Investor Relations Department at [email protected]. Participants in the Solicitation The Company and certain of its directors and executive officers and other members of management and employees may be deemed t o b e participants in the solicitation of proxies in respect of the proposed transaction. Information about the directors and executive officers of the Company, includ ing a description of their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement for its 2024 Annual General Meeting, which was filed w ith the SEC on April 15, 2024 and other documents that may be filed from time to time with the SEC. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests in the proposed transaction, by security holdings or otherwise, will be contained in the proxy statement and other relevant mate ria ls to be filed with the SEC regarding the proposed transaction when such materials become available.
Agenda Corporate Overview and Strategy LOQTORZI ® : Approved, Foundational PD - 1 Innovative LOQTORZI Combinations Commercial Oncology Opportunity Financial Results and Outlook 4 4 ©2025 Coherus BioSciences
Agenda 5 ©2025 Coherus BioSciences Corporate Overview and Strategy LOQTORZI ® : Approved, Foundational PD - 1 Innovative LOQTORZI Combinations Commercial Oncology Opportunity Financial Results and Outlook
Antibody Pipeline Toripalimab - tpzi (LOQTORZI): next - generation PD - 1 inhibitor Casdozokitug: IL - 27 antagonist CHS - 114: anti - CCR8 CHS - 1000: anti - ILT4 Fully Integrated Model Maximizes Value Commercia : Oncology expertise Revenue - generating Oncology Products Fully Integrated, Commercial Stage Innovative Oncology Company Leveraging Commercial Insights to Identify, Develop Promising Assets 6 ©2025 Coherus BioSciences DEVELOPMENT COMMERCIAL Innovative Oncology Competitive Pipeline Revenue Generating Products Expertise Expertise Leadership Proven drug development expertise Discovery of >30 marketed products Regulatory Success 6 FDA approvals Marketed Drugs 5 product launches Highly experienced team has commercialized 30+ products
Sharpened Focus on Innovative Oncology Biosimilar Divestitures Strengthens Balance Sheet, Funds Pipeline 7 ©2025 Coherus BioSciences Strategic Transformation ~$ 800M Biosimilar Asset Divestitures Non - dilutive Capital Raised 2024 - 2025 2025 - 2030 CIMERLI YUSIMRY UDENYCA* ~$ 480M Debt Retirement* Positioned for Growth and Value Creation • Next - generation PD - 1 • Growing sales (NPC) • Combinations with pipeline (1+1) • Pipeline differentiated & competitive • Unmet need • Value creation • Clean balance sheet • Streamlined operations • 2 - year cash runway * Coherus expects to close on the divestiture of its last biosimilar business, the UDENYCA franchise, to Intas Pharmaceuticals Ltd. in Q1 2025 and use a portion of the up to $483 million up - front cash proceeds to fully repay Coherus’ $230M convertible term loan and buy - out $49M in royalty obligations related to UDENYCA.
LOQTORZI : Foundational Building Block for a Diversified Immuno - Oncology Portfolio – Bringing I - O Beyond NPC 8 ©2025 Coherus BioSciences An approved PD - 1 is a distinct strategic advantage in Immuno - Oncology and is required to be a market leader Novel Combinations Unlock Value $15B Significant Market Opportunity Potential - $15 Billion Clinical Activity in Combination with Chemo Irrespective of PD - L1 Levels Novel Combinations Extend Patient Survival Binds to a Unique Epitope with High Affinity *See slide 7 for indications and product candidates that make up the expected market opportunity
US Drug Treatable Cases 1 Setting Molecule ~24K 1L Advanced HCC (Hepatocellular Carcinoma) Casdozokitug / Toripalimab ~100K 2L NSCLC (Non - Small Cell Lung Cancer) Casdozokitug / Toripalimab ~15K 2L HNSCC (Non - Nasopharyngeal Head and Neck Squamous Cell Carcinoma) CHS - 114 / Toripalimab ~13K 2L Gastric Cancer CHS - 114 / Toripalimab ~5K Limited stage SCLC (Small Cell Lung Cancer) Toripalimab / BTLA ~2K Locally advanced High Risk HNSCC HPV - 16/18+ 2 (Head and Neck Squamous Cell Carcinoma) Toripalimab / INO - 3112 1 Based on expected drug treated US patient population in 2030. Source: Decision Resources December 2023. 2 Based on locally advanced non - nasopharyngeal carcinoma, 60% HPV+, and 90% with HPV16 ©2025 Coherus BioSciences 9 I - O Pipeline and Lifecycle Access ~$15B Market Opportunity Combinations include multiple Coherus assets, multiplying sales potential
Agenda ©2025 Coherus BioSciences 10 Corporate Overview and Strategy LOQTORZI ® : Approved, Foundational PD - 1 Innovative LOQTORZI Combinations Commercial Oncology Opportunity Financial Results and Outlook
Rajasekaran, N., Wang, X., Ravindranathan, S. et al. Toripalimab, a therapeutic monoclonal anti - PD - 1 antibody with high binding affinity to PD - 1 and enhanced potency to activate hu man T cells. Cancer Immunol Immunother 73 , 60 (2024). Toripalimab’s Unique Binding Epitope on PD - 1 and Receptor Affinity Translates to Preclinical Differentiation 11 ©2025 Coherus BioSciences Epitope drives activity Toripalimab P otent binding affinity for PD - 1 (>10x other approved PD - 1) Epitope K D ( nM ) Antibody FG loop 0.3 Toripalimab CD loop 7.0 Pembrolizumab N - terminus 10.5 Nivolumab Toripalimab i nduces strong T cell activation and inflammatory signature in various in vitro and ex vivo assays
Pembrolizumab Toripalimab PD - L1 ≥ 10 PD - L1 < 10 HR = 0.61 Source: Shun Yamamoto, Ken Kato, JUPITER - 06 establishes immune checkpoint inhibitors as essential first - line drugs for the treat ment of advanced esophageal squamous cell carcinoma, Cancer Cell, Volume 40, Issue 3, 2022, Pages 238 - 240, ISSN 1535 - 6108, https ://doi.org/10.1016/j.ccell.2022.02.009. Pembrolizumab Jong - Mu Sun, Pembrolizumab plus chemotherapy versus chemotherapy alone for first - line treatment of advanced oesophageal cancer (KEYNOTE - 590): A randomized, placebo - controlled phase 3 study. The Lancet, Vol 398. August 28, 2021. HR = 0.61 HR = 0.62 HR = 0. 86 KEYNOTE - 590 JUPITER - 06 Toripalimab in combination with chemotherapy also demonstrated an improvement in PFS and OS over placebo across all PD - L1 expression levels for NPC and NSCLC trials PD - L1 + chemo Control (placebo + chemo) JUPITER - 06 Toripalimab Data with Chemotherapy In ESCC: Differentiated PD - 1 Inhibition Activity for Toripalimab 12 ©2025 Coherus BioSciences Toripalimab
Coherus is focused on combination I - O therapies that can improve response rates and extend durability, without significant additional toxicity Toxicity Compromises opportunity for later line treatments and decreases Overall Survival Minority of patients respond to PD - 1 therapy Lack of durability from cytotoxic and targeted Rx, despite significant ORR 13 Despite PD - 1’s Success, Significant Unmet Need Exists in I - O PD - (L)1 Inhibitors Remarkable, But Minority Of Cancer Patients Benefit 13 ©2025 Coherus BioSciences
Competitively - Positioned Immuno - Oncology Pipeline Combinations include Coherus assets, multiplying value opportunity 14 ©2025 Coherus BioSciences © 2024 Coherus BioSciences. Phase 3 Phase 2 Phase 1 Pre - Clinical Combo Indication Agent Gemcitabine/ Cisplatin 1L Nasopharyngeal Carcinoma (NPC) Anti - PD - 1 monoclonal antibody Monotherapy 2L+ NPC Atezolizumab/ Bevacizumab Hepatocellular Carcinoma (HCC) Anti - IL - 27 antagonist monoclonal antibody Casdozokitug Toripalimab / Bevacizumab 1L HCC Toripalimab Non - Small Cell Lung Cancer Monotherapy and Toripalimab Combination Solid Tumors including HNSCC Anti - CCR8 cytolytic monoclonal antibody CHS - 114 Toripalimab 2L Gastric Cancers Monotherapy and Toripalimab Combination Solid Tumors Anti - ILT4 monoclonal antibody CHS - 1000 U.S. Launch January 2024 U.S. Launch January 2024 Study Initiated 4Q24 Final data to be reported 1Q25 Planning Stages Study Initiation 1Q 25 ~24K Treatable 1L US Patients ~100K Treatable 2L US Patients ~15K Treatable 2L US Patients ~13K Treatable 2L US Patients Study Ongoing Study Ongoing
Agenda ©2025 Coherus BioSciences 15 Corporate Overview and Strategy LOQTORZI: Approved, Foundational PD - 1 Innovative LOQTORZI ® Combinations Casdozokitug: IL - 27 Antagonist CHS - 114: Anti - CCR8 (Treg depleter ) Commercial Oncology Opportunity Financial Results and Outlook
Strong line - of - sight for target indications (HCC, NSCLC) Acceptable safety profile; no added toxicity in combinations Demonstrated monotherapy durable responses Immune activation in cancer patients via non - PD - 1 MoA 16 Casdozokitug ( casdozo , CHS - 388): Phase 2 Clinical Stage Program Casdozokitug: First - In - Class IL - 27 Antagonist Distinct I - O Mechanism and Activity in Lung and Liver Patients 16 ©2025 Coherus BioSciences Liver Lung
IL - 27 Percentage positive CD8 + T Cells +IL - 27 Control T N F ⍺ p g /m L +IL - 27 Control PD - L1 Lag3 Tigit Tim3 IL - 27R Pro - inflammatory cytokines IL - 27 ra +/ - IL - 27ra - / - Myeloid DC IL - 27 T cell T cell NK cell NK cell T cell IL - 27 downregulates pro - inflammatory cytokines IL - 27 Represents A Novel Immune Target That is Complementary to PD - 1 17 IL - 27, when Present, Inhibits NK and T Cell Antitumor Response Immunoregulatory Cytokine Modulates Immune Response, Immune Pathology, and Tumor Immune Evasion 17 ©2025 Coherus BioSciences IL - 27 upregulates checkpoint receptors IL - 27 constrains NK cell immunosurveillance
Aghayev , et al. Cancer Discovery . 2022 Rausch et al. SITC P727 J Immunother Cancer. 2020 Antitumor activity ( casdozo Rx) Tumor location In vivo study No activity No acceleration of tumor growth SQ Multiple SQ syngeneic tumor models No activity SQ B16 lung metastasis model Antitumor activity Lung No activity Kidney RCC orthotopic model, with lung metastasis Anti - metastatic activity Lung Antitumor activity Liver HCC models (carcinogen, NASH, HEP1 - 6) Lung metastases in B16 melanoma model HCC model (NASH driven ) In Vivo Studies With Casdozo Suggest Tissue - Specific Dependency for Antitumor Activity Treatment with Anti - IL - 27 Ab Inhibits Lung and Liver Tumor Growth in Mouse Models: Barrier Tissue - Specific Activity 18 ©2025 Coherus BioSciences In Vivo Studies data consistent with IL - 27 biology in barrier tissues such as liver and lung
Clinical Translation: Casdozo Activates Immune Responses and Completely Inhibits IL - 27 Signaling in Cancer Patients at ≥ 10 mg/kg 19 ©2025 Coherus BioSciences Casdozo Rx at ≥ 10 mg/kg • I nhibits IL - 27 signaling • Activates T and NK cells • Activates tertiary lymphoid structures (PBMC) Phase 1 Clinical Study CHS - 388 - 101 IFNG 10 mg/kg Casdozo Rx Increases serum IFNg
Translation to Clinical Efficacy : NSCLC Monotherapy Antitumor Activity Two confirmed monotherapy PRs in α PD - (L)1 - experienced patients sqNSCLC 20 ©2025 Coherus BioSciences Response Evaluable (n=42) Best overall Response, n (%) 0 2 (4.8) 11 (26.2) 29 (69.0) Complete response Confirmed partial response Stable disease Progressive disease 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 Weeks -100 -80 -60 -40 -20 0 20 40 60 80 100 % C h a n g e f r o m B a s e l i n e Target Lesion Change Over Time (n=38) Data Cutoff Date: Aug. 27, 2024, subject to change. Casdozokitug Single Agent Clinical Activity Observed in NSCLC 2 confirmed PRs in PD - L1 negative or low squamous NSCLC, and 1 durable SD in adenocarcinoma • All 3 previously treated with aPD - (L)1 antibodies • Responses in 2/3L sq 5% ORR in all evaluable patients 22% ORR in RECIST evaluable squamous subset (n=2/9)
Casdozokitug Demonstrates Combination Activity and Safety 1L HCC Interim Results: 11 Durable Obj Responses, Including 3 Complete Responses 21 ©2025 Coherus BioSciences I nterim results from ongoing study (data cutoff Nov 9, 2023) – Final data results ASCO GI 2025 >60% of patients with tumor shrinkage on initial scans 38% ORR to date in response evaluable set (viral and nonviral patients) • 3 Complete Responses , 8* Partial Responses PFS 8.1 mos. Safety profile consistent with atezo/bev alone Biomarker data show association of response with IL - 27 pathway Casdozokitug/Atezolizumab/Bevacizumab in Hepatocellular Carcinoma (HCC) Best Percent Change from Baseline in Sum of Target Lesions (n=28)
Study CHS - 388 - 202 in HCC: Dose Optimization/Contribution to Determine RP2D and Obtain Preliminary Efficacy Outcomes 22 ©2025 Coherus BioSciences Primary Endpoint • Objective Response Rate (ORR) Key Endpoint • Duration of response ( DoR ) Secondary Endpoints: Efficacy • Progression - free survival (PFS) • Overall Survival (OS) • Disease control rate (DCR) Safety • AE/SAE • AESI PK Immunogenicity Exploratory Endpoints • Biomarkers Casdozokitug Stratification Factors • Geographical region: Asia, excluding Japan, versus the rest of the world • Macrovascular invasion or extrahepatic spread of disease (presence vs. absence) Patient Population • 1L unresectable/ metastatic HCC • >=1 measurable lesion • Not suitable for surgical or local therapy • Child - Pugh A • ECOG - PS Score: 0 or 1 • Controlled HBV or Cured HCV Arm C: Toripalimab + Bevacizumab Arm A: Toripalimab + Bevacizumab + Casdozo Dose 1 Arm B: Toripalimab + Bevacizumab + Casdozo Dose 2 N=72 R in 1:1:1 CHS - 388 - 202: FPI targeted for 1Q25 with data readouts in 1H26 Results will support a go/no go for pivotal study Toripalimab P3 HEPATORCH data to support contribution of component Casdozo has Orphan Drug Designation in HCC
Agenda ©2025 Coherus BioSciences 23 Corporate Overview and Strategy LOQTORZI: Approved, Foundational PD - 1 Innovative LOQTORZI ® Combinations Casdozokitug: IL - 27 Antagonist CHS - 114: Anti - CCR8 (Treg depleter ) Commercial Oncology Opportunity Financial Results and Outlook
High unmet need in multiple indications including CRC (I - O has not worked historically) and HNSCC (low survival with approved PD - 1s) Overcoming Treg immune suppression by recruiting T cells to turn “cold” tumors “hot,” with no added toxicity Specifically binds and preferentially depletes CCR8+ tumor Tregs, with no off - target binding CHS - 114: Phase 1 Clinical Stage Program 24 CHS - 114 is a Highly Selective Anti - CCR8 mAb with the Potential to Augment I - O Therapy Via Depletion of Treg Mediated Tumor Immune Suppression 24 ©2025 Coherus BioSciences Head & Neck Strong line - of - sight for additional target indications Gastric Colorectal (I - O Desert) Esophageal
GPCRs are difficult targets for mAbs and commonly have off - target binding Number of non - CCR8 Targets Identified Selected Antibodies 0 CHS - 114 1 mAb2 8 mAb3 15 mAb4 20 mAb5 Non - CCR8, “Off Target” Binding Comparator Antibodies ANGPTL7 Comparator 1 J chain Comparator 2 SEMA4B Comparator 3 CCR8 Antibody Screen* *Ab specificity profiling using cell microarray to uncover extracellular antibody targets; Assay screens across 5,528 cell su rfa ce and secreted proteins using cell microarray technology; 293T cells transfected and fixed prior to binding; IgG antibodies bound to Fc gamma recepto rs Only ~25% of the receptor is exposed on the cell surface 25 EC L1 EC L3 IC L1 IC L2 IC L3 C - term N - term CC L1 CCR8 CHS - 114 Binds Only to CCR8, the Only Selective mAb Known to Date GPCRs have known issues with mAb S electivity 25 ©2025 Coherus BioSciences
CCR8 + Tregs are Most Abundant in HNSCC , Cervical SCC, and Gastric, but Broadly Expressed in a Number of Solid Tumors, Including Colorectal and Lung ©2025 Coherus BioSciences C e r v i c a l S C C H N S C C G a s t r i c C R C E s o p h a g e a l B r e a s t N S C L C O v a r i a n H C C E n d o m e t r i a l B l a d d e r c c R C C 0 50 100 150 200 250 300 C C R 8 + T r e g c e l l s / m m 2 G a s t r i c C e r v i c a l S C C H N S C C E s o p h a g e a l O v a r i a n E n d o m e t r i a l H C C B r e a s t C R C N S C L C c c R C C B l a d d e r 0 10 20 30 40 50 60 70 80 90 100 % C C R 8 + o f T r e g TMA dataset from US Biomax CCR8+ Tregs (density) CCR8+ Tregs (of total Tregs) CCR8+ Tregs (density vs frequency) 26
CHS - 114 Phase 1 Study Design: Head and Neck Cancer Dose Expansion: 2L+ HNSCC (CHS - 114 monotherapy and in combination with toripalimab ) 27 ©2025 Coherus BioSciences Primary Endpoint • Safety and tolerability Key Secondary Endpoints • Pharmacokinetics (PK) • Objective Response Rate † (ORR) • Additional measures of efficacy including: • Duration of response † ( DoR ) • Disease control rate † (DCR) • Progression - free survival † (PFS) • Biomarker Endpoints • Treg depletion in tumor CHS - 114 Low Dose Levels CHS - 114 Mid Dose Levels CHS - 114 High Dose Levels Determine Dose for Expansion Arm 1a: Monotherapy Dose Escalation Completed Arms 1b and 2: Monotherapy and Combination Dose Expansion in 2L+ HNSCC CHS - 114 Expansion Dose 2 CHS - 114 + Toripalimab Combination Dose 1 CHS - 114 Expansion Dose 1 CHS - 114 + Toripalimab Combination Dose 2 ClinicalTrials.gov ID: NCT05635643 † Per RECIST 1.1 based on investigator assessment CHS - 114
CHS - 114 Selectively Depletes CCR8+ Tregs Establishing Proof of Mechanism in Phase 1a Monotherapy Dose Escalation 28 ©2025 Coherus BioSciences CHS - 114 treatment led to a decrease in subset of total Tregs, while preserving broader Treg population confirming the specificity for CCR8+ Tregs Total frequency of CCR8+ Tregs from baseline (left) and percent decrease of total Tregs (right) was measured in peripheral bl ood mononuclear cells (PBMC) by a flow - cytometry assay at DL3 - DL7. CCR8+ Treg depletion was stable through cycle 1, with > 85% of CCR8+ Tregs being depleted for all dose levels tested, confirming the proof of mechanism. Additionally, depleti on was observed at DL3 (and higher doses), which was lower than predicted dose from in vitro modeling. Furthermore, CHS - 114 treatment led to a decrease in subset of total Tregs, while preserving broader Treg population, confirming the specifici ty of CHS - 114 for CCR8+ Tregs. Tregs were defined as CD127low CD25high cells within the CD3+ CD4+ T cell population. Data representative of 3 patients per dose level (n=2 - 3 samples per timepoint). Error bars = SEM. Data cut as of 16 April 2024; subject to change J Clin Oncol 42, 2024 (suppl 16; abstr 2664) 28 Percentage decrease total Tregs - Selectivity for CCR8+ Tregs Frequency of CCR8+ Tregs - Complete depletion
Phase 1a Monotherapy Dose Escalation Response Summary H ighly refractory 2L+ HNSCC patients showed encouraging disease control 29 ©2025 Coherus BioSciences Response Evaluable N = 19 Best Overall Response n (%) 0 Complete Response 0 Partial Response 9 (47.4%) Stable Disease 10 (52.6%) Progressive Disease Disease assessment performed every 9 weeks 29 Data cut as of 16 April 2024; subject to change J Clin Oncol 42, 2024 (suppl 16; abstr 2664) Based on Investigator Assessment per RECIST v1.1 Target Lesion Change Over Time (n=19)
CHS - 114 Phase 1a Data Establishes Safety, Proof of Mechanism Phase 1b Studies in HNSCC and Gastric Cancer to establish Proof of Concept 30 ©2025 Coherus BioSciences Phase 1b Expansion Ongoing - HNSCC Phase 1b Study Start Q1 ‘25 - Gastric • Two dose levels of CHS - 114 with and without toripalimab expansion phase ongoing in 2L+ HNSCC patients • Initiate Phase 1b CHS - 114/toripalimab combination dose optimization study in Q1 2025 • Initiation of Phase 1b CHS - 114/ toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 CHS - 114 Phase 1a Monotherapy Results 1 Safety & Proof of Mechanism • Acceptable safety profile in heavily pretreated patients with advanced solid tumors • No depletion of CD4+ or CD8+ T cells • Depletion of peripheral CCR8+ Tregs was observed and CCR8+ Treg depletion was maintained • Results and safety profile support combination with toripalimab Strong Biologic Rationale: HNSCC and Gastric Cancer Have High Prevalence and Density of CCR8+ Tregs Data Readouts from Phase 1b Studies in HNSCC and Gastric Cancer Expected in Q2 2026 1. J Clin Oncol 42, 2024 (suppl 16; abstr 2664)
Agenda ©2025 Coherus BioSciences 31 Corporate Overview and Strategy LOQTORZI ® : Approved, Foundational PD - 1 Innovative LOQTORZI Combinations Commercial Oncology Opportunity Financial Results and Outlook
32 ©2025 Coherus BioSciences Only Preferred NCCN regimen in 2nd Line treatment and later Only I - O treatment with Preferred Category 1 designation under NCCN* in combination with gemcitabine and cisplatin Establishing position in rare indication with less competition Strong Clinical evidence (PFS and OS data ) LOQTORZI treatment patient segments ≈ 2,000 $150 - 200M NPC market valued at LOQTORZI (toripalimab - tpzi ) is indicated in combination with cisplatin and gemcitabine, for the first - line treatment of adults with metastatic or with rec urrent, locally advanced nasopharyngeal carcinoma (NPC) and as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum - containing chemotherapy. *NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Head and Neck Cancers Version 1.2025 — November 26, 2024 LOQTORZI ® : Establishing a New Standard of Care in NPC Only FDA - Approved Treatment for Nasopharyngeal Carcinoma* in All Lines of Therapy
Recently Revised NCCN NPC Guidelines Clearly Establishes LOQTORZI ® as the Only PREFERRED Regimen for NPC Patients 33 ©2025 Coherus BioSciences Commercial Impact: Opportunity to Accelerate Ramp to Peak Sales Updated promotional materials to drive rapid & broad awareness of the NCCN guidelines update, including: • Leverage new guidelines to implement changes that have longer timelines • Drive revisions to Institution NPC pathway and treatment plans
~2,000 LOQTORZI ® Treatment Eligible Patients Annually Across Three Patient Segments 34 ©2025 Coherus BioSciences Source: Historical data from DRG: Squamous Cell Carcinoma of the Head and Neck - Epidemiology - Mature - Markets - All - Populations - Geogr aphic - Summary & Internal A ssumptions on patient growth driven by improved treatment options Recurrent Locally Advanced m1L Drug Treatable m2L+ Drug Treatable LOQTORZI Treatment Patient Segments = ~ 2,000 = 33% = 33% = 33% Typical NPC Patient Treatment Chemo +/ - I - O Chemo or I - O Chemo +/ - I - O I - O use can now be FDA - approved LOQTORZI but off - label I - O enabled by NCCN Guidelines listing (current off - label I - O use estimated to be 25%) 1 2 3 Stage 1 - 4a with Local or Regional recurrence following initial intervention ( generally chemo - radiation, radiation, or surgery) NPC market valued at $150 - $200M
Long - Term LOQTORZI ® Revenue Ramp Driven by Accessing Early - Line Patients Who have Longer Duration of Treatment 35 ©2025 Coherus BioSciences Locally Advanced/Regional Recurrent m1L Drug Treatable m2L+ Drug Treatable Segment Revenue Impact Duration of LOQ Use HIGH HIGH LOWER LONGEST LONGEST SHORTEST ILLUSTRATIVE Revenue Ramp New Patients Continued Patients 2024 2028
12 6 7 36 ©2025 Coherus BioSciences CCR8+ Treg (cells/mm 2 ) 150 100 50 0 0 50 100 150 200 4 10 5 8 1 2 9 11 3 1. HNSCC 2. Gastric 3. Cervical 4. NSCLC 5. Bladder 6. Endometrial 7. HCC 8. Breast 9. Esophageal 10. CRC (1) 11. Pancreatic (1) 12. Ovarian (1) 13. RCC 14. Mesothelioma Patient population (thousands) Market Size, $B 20+ 5+ 2+ 1+ 0.5 (1) No approved anti - PD(L)1 (IO desert) Ongoing studies CHS - 114 Approved anti - PD(L)1 1 2 3 IL - 27 mRNA expression (Log2(TPM+1)) 1 3 8 4 11 2 1 7 Ongoing study casdozo Ongoing study casdozo CHS - 114 Ongoing study casdozo 14 I - O Portfolio has Broad Market Potential, Including I - O Treatment Deserts
2K 2K 2K 2K 2K 2K 2K 5K 5K 5K LOQTORZI NPC: 2K LOQTORZI (+ casdozo ) 1L HCC: 24K LOQTORZI (+ casdozo ) 2L NSCLC: 100K LOQTORZI (+CHS - 114) 2L Gastric: 13K LOQTORZI (+CHS - 114) 2L HNSCC: 15K Casdozokitug (+LOQ) 1L HCC: 24K Casdozokitug (+LOQ) 2L NSCLC: 100K LOQTORZI (+INO - 3112) HPV+ HNSCC: 2K LOQTORZI (+BTLA) LS - SCLC: 5K CHS - 114 (+LOQ) 2L Gastric: 13K CHS - 114 (+LOQ) 2L HNSCC: 15K 24K 100K 24K 100K 15K 13K 24K 100K 24K 100K 15K 13K 37 ©2025 Coherus BioSciences Toripalimab Represents an Indication Value Multiplier with Combinations Pipeline molecules and lifecycle access ~$15B of market opportunity in the U.S. alone
Agenda ©2025 Coherus BioSciences 38 Corporate Overview and Strategy LOQTORZI: Approved, Foundational PD - 1 Innovative LOQTORZI Combinations Commercial Oncology Opportunity Financial Results and Outlook
2024 Preliminary Revenues and Cash 39 ©2025 Coherus BioSciences 2024 Total Year Expected Net Revenues $255M - $260M Cash, Cash Equivalents & Investments Q4 expected net revenues $49M - $54M OBI and strong pricing continue to differentiate the franchise and drive net revenues UDENYCA LOQTORZI Expected sales of $7M - $8M, with consecutive QoQ growth exceeding 20% since launch in Q1 Expected sales of $42M - $47M signaling strength of demand following temporary supply interruption Year - end cash, cash equivalents and investments expected to be reported at ~$ 125 M Following expected divestiture of the UDENYCA ® Franchise for up to $558.4M proceeds will be used to repay the entirety of the company’s $230 million convertible notes due April 2026 Current post - close cash runway projections exceed two years , past key data readouts expected in 2026 The preliminary 2024 financial information presented herein has not been audited and is subject to change. The complete Coher us Fourth Quarter and Full Year 2024 Financial Results are planned for release in March 2025. The closing of all the proposed transactions, including the divestiture of the UDENYCA® Franchise and repayment of the entirety of the company’s $23 0 m illion convertible notes due April 2026, are subject to various conditions, including customary closing conditions, approval by Coherus shareholders, expiration or termination of the applicable waiting period under the Hart - Scott - Rodino Antitru st Improvements Act of 1976, any required approval by the Committee on Foreign Investment in the United States (CFIUS) as well as certain other conditions.
Coherus I - O Milestones and Data Catalysts* 40 ©2025 Coherus BioSciences 2H’24 1H’25 2026 Casdozokitug (IL - 27) CHS - 114 (CCR8) Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in first - line (1L) HCC initiated Q4 2024 Final data from Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC in Q1 2025 at ASCO GI Report data from Phase 1 study of casdozokitug/toripalimab in second to fourth line (2 - 4L) NSCLC in 1H 2025 Initiate a Phase 1b CHS - 114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 Initiate a Phase 1b CHS - 114/toripalimab combination dose optimization study in 2L HNSCC in Q1 2025 Report Phase 1 CHS - 114 monotherapy biopsy data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025 Report CHS - 114/toripalimab combination safety data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025 Data readouts from Phase 2 randomized trial of casdozokitug/toripalimab /bevacizumab in first - line (1L) HCC in 1H 2026 First data readouts from Phase 1b CHS - 114/toripalimab combination studies in 2L gastric cancer and 2L HNSCC expected in Q2 2026 * * * * * *
Fully Integrated Business Model Maximizes Value Commercia : Oncology expertise Revenue - generating Oncology Products Fully Integrated, Commercial Stage Innovative Oncology Company Retain full value of pipeline in the US; Capture Ex - US Value via Partners 41 ©2025 Coherus BioSciences DEVELOPMENT COMMERCIAL Innovative Oncology Highly Competitive Pipeline Finance and Operations Strong Commercial Capability Global Rights » Commercial Product » Growing Revenue » Global Pivotal Trials » Territory Monetization » Development Cost Sharing » Clean balance sheet » Streamlined operations » 2 - year cash runway
Thank You / Q&A