Form 8-K - Current report

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): June 01, 2024

   

CORBUS PHARMACEUTICALS HOLDINGS, INC.

(Exact name of Registrant as Specified in Its Charter)


Delaware	001-37348	46-4348039
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

500 River Ridge Drive
Norwood, Massachusetts		02062
(Address of Principal Executive Offices)		(Zip Code)

    Registrant’s Telephone Number, Including Area Code: (617) 963-0100

   

    Not Applicable

   

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	CRBP	The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On June 1, 2024, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release announcing data from the ongoing Phase 1 clinical trial for SYS6002 (CRB-701) conducted by the Company’s development partner, CSPC Pharmaceutical Group, that was presented at the American Society of Clinical Oncology Annual Conference (the “ASCO Annual Conference”) on June 1, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

The Company also updated its presentation used by management to describe its business. A copy of the presentation is furnished as Exhibit 99.2 and is incorporated herein by reference.

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibits 99.1 and 99.2, is being furnished to the Securities and Exchange Commission (the “SEC”), and shall not be deemed to be “filed” for the 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 shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

Item 8.01 Other Events.

On June 1, 2024, the Company announced data from the ongoing Phase 1 clinical trial of SYS6002 (CRB-701) conducted by the Company’s development partner, CSPC Pharmaceutical Group, that was presented at the ASCO Annual Conference on June 1, 2024.

The Phase 1 dose escalation study is being conducted in China and is enrolling patients with advanced solid tumors who have failed or were intolerant to standard treatment. Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive. The study opened for enrollment in January 2023 and the data presented is through April 2024 from 25 patients reflective of seven dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/Kg Q3W) and PK cohorts (2.7 and 3.6 mg/Kg).

Emerging clinical safety profile:

•

SYS6002 (CRB-701) was generally well tolerated with mainly grade 1 or 2 AEs.

•

No DLTs or grade 4 or 5 AEs have been observed to date.

•

Anemia and eye-related treatment emergent AEs (TEAEs) were the most common.

•

One patient exhibited a grade 3 rash which lasted for eight days and did not result in a reduction or interruption in dosing (2.7 mg/Kg). Two milder cases of skin rash were recorded (grade 1 and grade 2). Both also resolved with no need for change or interruption in dosing.

•

No new drug-related SAEs have been encountered since the January 2024 data update.

•

To date, a single case of peripheral neuropathy (grade 1) has been reported (numb hands) associated with hypokalemia (grade 3). It resolved in parallel with the hypokalemia after ten days of combined oral and/or parenteral K+ replacement therapy.

•

Two grade 3 corneal disorders were reported in patients who received 2.7 mg/Kg and 3.6 mg/Kg, respectively. Preventative eye measures have been introduced and no such cases have been seen so far at the 4.5 mg/Kg dose. Over 50% of patients enrolled had corneal disorders or dry eye at baseline.

Emerging efficacy profile

•

Anti-tumor responses across multiple doses continue to be observed, with the ﬁrst conﬁrmed stable disease at 0.6 mg/Kg and the ﬁrst conﬁrmed partial response (PR), at 1.2 mg/Kg.

•

To date, SYS6002 (CRB-701) resulted in 44% overall response rate (ORR) and 78% disease control rate (DCR) in mUC (n=9, 4 PRs, 1 unconfirmed) and 43% ORR and 86% DCR in cervical cancer (n=7, 3 PRs, 1 unconfirmed).

•

For all the tumor types combined at doses ≥ 2.7 mg/Kg, SYS6002 (CRB-701) resulted in 40% ORR and 73% DCR (n=15, 6 PRs, 2 unconfirmed). An additional PR was confirmed at the 1.2 mg/Kg for an mUC patient. Two unconfirmed PR’s reported at ASCO-GU have since been confirmed.

Emerging clinical pharmacology

•

After a single IV infusion of SYS6002 (CRB-701), the exposure of ADC and MMAE generally increased in a dose proportional manner up to 2.7 mg/Kg.

•

Dosing beyond the 2.7 mg/Kg level showed a leveling off of free MMAE.

•

All dose levels studied to date are showing lower average levels of free MMAE than enfortumab vedotin at the reference dose (1.25 mg/Kg dosed on days 1, 8 and 15 of a 28-day cycle).

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits


Exhibit No.		Description
99.1		Press Release dated June 1, 2024
99.2		Investor Presentation
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.


			Corbus Pharmaceuticals Holdings, Inc.

Date:	June 3, 2024	By:	/s/ Yuval Cohen
			Name: Yuval Cohen Title: Chief Executive Officer

Exhibit 99.1

SYS6002 (CRB-701) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in Patients with Nectin-4 Positive Tumors in a Clinical Update Presented at ASCO 2024

•

An additional 19 patients have been enrolled since January 2024 bringing the total to 37 of whom 25 were evaluable for efficacy

•

SYS6002 (CRB-701) demonstrated 44% ORR and 78% DCR in mUC and 43% ORR and 86% DCR in cervical cancer to date at doses ≥ 1.2mg/Kg

•

No dose limiting toxicities (DLTs) have been observed to-date in doses up to and including 4.5 mg/Kg (cohort 7)

•

Three cases of skin rash (including one grade 3) and one case of grade 1 neuropathy seen to-date; all were resolved

•

Early PK data demonstrate consistently lower levels of free MMAE than enfortumab vedotin across all doses in study including 4.5 mg/Kg

Norwood, MA, June 1, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today, that the Poster [#296] Clinical Update Related to the First-In-Human Trial of SYS6002 (CRB-701), A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate, has been presented at American Society of Clinical Oncology (ASCO) Annual Conference by Dr. Jian Zhang, Chief Physician (Oncology), Deputy Director of Administration, Clinical director of Phase 1 Centre, Fudan University Shanghai Cancer Center.

The Phase 1 study, sponsored by CSPC Pharmaceuticals Group Limited in China, is evaluating the safety and tolerability of SYS6002 (CRB-701) in patients with advanced solid tumors who have failed or were intolerant to standard treatment. Patients were enrolled based on Nectin-4 staining with the exception of metastatic urothelial cancer (mUC) patients who were considered to be Nectin-4 positive. The poster presents data as of the end of April 2024 from the dose escalation spanning 7 dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/Kg Q3W) and PK cohorts (2.7 and 3.6 mg/Kg).

“This latest data update provides additional insight following the initial observations from our partner CSPC’s January 2024 data cut” said Dr. Dominic Smethurst, Chief Medical Officer at Corbus. "This larger set of patient data, along with additional confirmed responses, increases our confidence that CRB-701 is clinically active. Similarly, we find the emerging safety data reassuring with its low rates of skin rash and peripheral neuropathy and very few grade 3 adverse events. Lastly, it is satisfying to observe the translation from the pre-clinical to the clinic of significantly lower levels of free MMAE due to the stability of this ADC construct.”

Emerging clinical safety profile:

•

SYS6002 (CRB-701) was generally well tolerated with mainly grade 1 or 2 AEs.

•

No DLTs or grade 4 or 5 AEs have been observed to date.

•

Anemia and eye-related treatment emergent AEs (TEAEs) were the most common.

•

No new drug related SAEs have been encountered since the January 2024 data update.

•

Emerging efficacy profile

•

Anti-tumor responses across multiple doses continue to be observed, with the ﬁrst conﬁrmed stable disease at 0.6 mg/Kg and the ﬁrst conﬁrmed partial response (PR), at 1.2 mg/Kg.

•

Emerging clinical pharmacology

•

After a single IV infusion of SYS6002 (CRB-701), the exposure of ADC and MMAE generally increased in a dose proportional manner up to 2.7 mg/Kg.

•

Dosing beyond the 2.7 mg/Kg level showed a leveling off of free MMAE.

•

All dose levels studied to date are showing lower average levels of free MMAE than enfortumab vedotin at the reference dose (1.25 mg/Kg dosed on days 1, 8 and 15 of a 28-day cycle).

“We are encouraged by this latest data release” said Dr. Yuval Cohen, Chief Executive Officer at Corbus. “The corresponding US clinical study is progressing well and is expected to be on schedule for completion in Q4 with data presentation in Q1 2025. We believe the emerging dataset positions CRB-701 to be a differentiated Nectin-4 ADC. We look forward to generating more data in a number of specific Nectin-4 solid tumors.”

About CRB-701

CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 with a third generation, site-specific cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. SYS6002 (CRB-701) is currently being explored in a dose escalation on a Q3W schedule, with a view to reducing free-MMAE concentrations in plasma, reducing the associated toxicities that are believed to dose limit the Nectin-4 ADC PADCEV® (enfortumab vedotin). Additionally, by administering SYS6002 (CRB-701) on a Q3W schedule there is an opportunity to increase clinical convenience and patient compliance.

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.

INVESTOR CONTACT:

Sean Moran

Chief Financial Officer

Corbus Pharmaceuticals

smoran@corbuspharma.com

Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com

Connecting Innovation to Purpose NASDAQ: CRBP Corporate Presentation June 1, 2024 Exhibit 99.2

This presentation contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, including timing or completion of trials and presentation of data and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identiﬁed by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our ﬁnancial performance and involve known and unknown risks, uncertainties, and other factors, on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s ﬁlings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. Forward-Looking Statements

Investment Summary $120M Cash, cash equivalents and investments as of March 31, 2024 10.5M Common Shares Outstanding (11. 6M Fully-Diluted Shares) Nectin-4 targeting ADC for treatment of solid tumors Oral CB1R inverse agonist to treat obesity TGFβ blocker Anti-⍺vβ8 integrin mAb for treatment of solid tumors CRB-913 CRB-601 CRB-701

Therapy Disease Indication Sponsor Pre-Clinical Phase 1 Phase 2 Phase 3 Milestones Next-Generation Nectin-4 targeting ADC CRB-701 Next-generation Nectin-4 targeting ADC Nectin-4 positivesolid tumors CSPC(China) Cohort 6 Expanding Corbus(US + Europe) First Patient Dosed Anti-Integrin mAb CRB-601Anti-⍺vβ8 mAb(TGFβ-targeting) ⍺vβ8 enriched solid tumors Corbus FPI Expected in Summer of 2024 Highly peripherally-restricted CB1R inverse agonist CRB-913 CB1R inverse agonist Obesity Corbus FPI Expected in Q1 2025 A Diversified Pipeline with Differentiated Clinical Risk Profiles

CRB-701 Next Generation Nectin-4 Targeting ADC

Padcev® Projected to Reach Up to ~$5B in Global Sales by 2028 Sources: 1. SGEN press release, October 2023, 2. Evaluate Pharma PADCEV® Global Projected Revenues in UC/Bladder2 $5B Latest Padcev® Q3 revenues 1 22nd October 2023 2 ® Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) in First-Line Advanced Bladder Cancer 22nd October 20231

Does Tolerability for Padcev® Impact Clinical Adoption? Source(s): PADCEV® Prescribing Information as of Apr 2023. Duration of Response~5 months 47% Rate of Serious Adverse Events (SAEs) 61% Dose Interruptions 34% Dose Reductions 17% Dose Discontinuations Revised: 4/2023 PADCEV® Prescribing Information EV-301: The safety of PADCEV was evaluated as a single agent in EV-301 in patients with locally advanced or metastatic urothelial cancer (n=296) who received at least one dose of PADCEV 1.25 mg/kg and who were previously treated with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy ®

Padcev® is Associated with Skin Toxicities and Peripheral Neuropathy Source(s): 1. PADCEV® Prescribing Information Dec 2023. 2.. Rosenberg et al., 2020 Adverse Events (% of Patients) ® A Black Box Warning1 Greater than 25% of PADCEV® discontinuations are linked to peripheral neuropathy 2 PADCEV® + Keytruda® patients who experienced neuropathy: 13% complete resolution 87% patients had residual neuropathy (45% had Grade ≥2)1 PADCEV® monotherapy1 PADCEV® + Keytruda®1 All Grades ≥ Gr 3 All Grades ≥ Gr 3 SkinReactions 58% 14% 70% 17% Peripheral Neuropathy 53% 5% 67% 7%

ADC drug TAA Average DAR Skin Rash Peripheral Neuropathy Padcev® Enfortumab vedotin Nectin-4 3.8 Adcetris®Brentuximab vedotin CD30 4 Tivdak®Tisotumab vedotin TF 4 Polivy® Polatuzumab vedotin CD79B 3.5 Aidixi®Disitamab vedotin HER2 4 Is the 2nd Generation Seagen® Linker the Cause? Padcev® Val-Cit linker + payload = mc-VC-PABC = Maleimidocaproyl-L-valine-L-citrulline-p-aminobenzyl alcohol p-nitrophenyl carbonate Source(s): 1. Fu et al., Science. 2023 doi: 10.1016/j.isci.2023.107778. Padcev® Prescribing information, Adcetris® Prescribing Information, Tivdak® Pescribing Information, Polivy® Prescribing Information. Shi et al., 2022 https://doi.org/10.1080/10717544.2022.2069883 Aidix® www.adcreview.com/drugmap/disitamab-vedotin Similar dose limiting toxicities seen across divergent ADCs that share same constellation of ‘linker + payload’ Val-Cit linker + vedotin (MMAE) payload All grades All grades

6 months of therapy = ~ 54 hours of total clinic time / patient Real-world use, dose intensity, and adherence to Padcev® Padcev® Requires Frequent Dosing and Real-world Usage Differs from Label Source(s): 1. PADCEV® Prescribing Information as of Dec 2019, 2. Redacted from Tsingas et al., ASCO 2023 Monotherapy Padcev® Metric Results (N=416) EV use Number of cycles (median, IQR) 5 (2,8) EV dose intensity Treatments per patient month (mean [SD]) 2.6 [0.6] Dosing frequency; treatments per cycle (mean [SD]) 2.4 [0.5] Dose (mean, mg/kg [SD]) 1.1 [0.2] Change in average does (mg) from baseline (%) -9.6 [20.2] % EV treatment adherence Received on average > 2 treatments per cycle (%) 58.8 [34.4] % Cycle length = 28 days 1.25 mg/kg 1.25 mg/kg 1.25 mg/kg Dose holiday Day 1 Day 8 Day 15 Day 22 Day 28

Nectin-4 targeting ADC for treatment of solid tumors Extend ADC half-life  Reduce dosing frequency Lower DAR + longer half-life  Dose higher than Padcev® Compliance Efficacy Toxicity Designing a Nectin-4 ADC Intended to Address Padcev® Unmet Needs

CRB-701: Next Generation Site-specific Nectin-4 Targeting ADC MMAE = Monomethyl auristatin E ADCC = antibody-dependent cellular cytotoxicity. CDC = complement dependent cytotoxicity DAR = Drug Antibody Ratio Source(s): Modified image from Corbus data on file; Corbus data on file

CRB-701: One Dose Every 21 Days Offers Advantages Over More Frequent Dosing Source(s): Corbus data on file; PADCEV® Prescribing Information as of Dec 2019 Padcev® CRB-701 Clinical Cycle Comparison Patient / Physician Convenience Combination Flexibility

ASCO 2024 Update: Phase 1 Dose Escalation Study (China) KEY ELIGIBILITY Age ≥ 18 years Advanced urothelial carcinoma or Nectin-4 positive Advanced solid tumors ECOG 0-1 Adequate organ function No uncontrolled diabetes No active CNS metastasis ESCALATION DESIGN Bayesian Optimal Interval (BOIN) design with accelerated titration at DL-1 IV Q3W over a 21-day cycle 0.2 mg/kg 0.6 mg/kg 1.2 mg/kg 1.8 mg/kg 2.7 mg/kg (expanding) 3.6 mg/kg (expanding) 4.5 mg/kg (escalating) KEY ENDPOINTS Safety/tolerability Pharmacokinetics Anti-tumor activity NEXT STEPS Continue escalation PK expansion at 2.7 &3.6 mg/Kg MTD or RP2D Specific expansion

ASCO 2024 Update: Demographics & Key Characteristics Characteristic Value Median age (range) 55 (35,76) Sex (M/F) 29.7%, 70.3% ECOG PS 0,1, missing 8.1%, 89.2%, 2.7% Weight in Kg mean (range) 59.01 (36.0, 84.9) Prior therapies median (range) 4.0 (0,10) Creatinine clearance <60μ mol/L 29.7% Visceral metastasis (Y/N/missing) 73%, 8.1%, 18.9% HbA1c <6.5% 97.3% Primary tumor type n=37 Urothelial 13 Cervical 15 TNBC/Breast 5 CRC 1 Esophageal 2 Not assigned 1 Corneal and conjunctival disease 53% (16 out of 30 reviewed) An additional 19 patients have been enrolled since January 2024 25 patients evaluable for efficacy assessment at data cut-end of April 2024

ASCO 2024 Update: Safety and Dose Modifications Dose Modifications n Discontinuations 0 Reductions 0 Interruptions 1 CRB-701 continues to be well tolerated with mainly grade 1 or 2 AEs Still no DLTs or Grade 4 or 5 AEs observed to date including in the 4.5 mg/Kg cohort No additional grade 3 treatment related SAEs since ASCO-GU data (Jan 2024) Summary of TEAEs ≥20% as of April 2024 cut-off date-37 patients evaluated

ASCO 2024 Update: TEAEs of Special Interest (<20% incidence) AE of special interest Grade Dose (n out of 37) Notes Skin rash 3 2.7 mg/Kg (n=1) Resolved after 8 days (no dose change) Skin rash 2 3.6mg/Kg (n=1) Resolved after 5 weeks (no dose change) Skin rash 1 3.6 mg/Kg (n=1) Resolved after 19 days (no dose change) Peripheral neuropathy 1 3.6 mg/Kg (n=1) Associated with underlying hypokalemia Resolved after 10 days therapy with K+ therapy No dose reduction or discontinuation Cornea 3 2.7 mg/Kg (n=1) 3.6 mg/Kg (n=1) Ocular prophylaxis recently introduced starting at 4.5 mg/Kg 53% of sampled patients at baseline had corneal or conjunctival pathology and were recruited on trial (acceptable per Chinese protocol)

Favorable Emerging Safety Profile vs. Nectin-4 ADC Competitors 1 Rosenberg, et al., JCO, 2020 Apr 1; 38(10): 1041–1049, 2. NDA/BLA Multidisciplinary Review and Evaluation BLA 761137 PADCEV™ (enfortumab vedotin-ievx), 3. BicycleTx R&D day Dec. 2023, 4. Mabwell Announces 9MW2821 Clinical Data and Latest Progress to be presented at 2024 ASCO Annual Meeting . 5 Clinical Update ASCO 2024 Jian Zhang et al Abst 3151. 6. Efficacy and safety of 9MW2821, an antibody-drug conjugate targeting Nectin-4, monotherapy in patients with recurrent or metastatic cervical cancer: A multicenter, open-label, phase I/II study. Yang et al SGO plenary Mar 2024. Limitation Padcev® BT8009 9MW-2821 CRB-701 Upper dose limit 1.25 mg/Kg1 5 mg/m3 1.25 mg/Kg4 No DLTs up to 4.5mg/Kg5 Schedule D1, D8, D15 /28 days Q1W D1, D8, D15 /28 days Q3W ≥ Grade 3 AE rate 58% (n=179 of 310)2 49% (n=55/113)3 70%(n=28/40)6 16% (n=6/37)5 Peripheral neuropathy 49% (n=76/155)1 22% (n=25/113)3 22.5% (n=54/240)4 3% (n=1/37)5 Skin reactions 45%1 (n=70/155)1 10% (n=11/113)3 30% (n=72/240)4 8% (n=3/37)5 Neutropenia (Gr 3) 6.8% (21/379)2 5%% (n=6/113)3 27.9% (n=67/240)4 0%5 Dose reduction 30.3% (n=94/310)2 21% (n=7/34)3 Not released 0%5 Dose interruptions 46.8% (n=145/310)2 44% (n=15/34)3 Not released 2% (n=1/37)5

ASCO 2024 Update: Pharmacokinetics Continuing to indicate differentiation from PADCEV Delivering higher amounts of ADC at the higher doses explored Consistently less free MMAE levels across all doses tested to-date 21 Day PK Comparison %ADC %Free MMAE Cmax AUC0-21d Cmax AUC0-21d Enfortumab vedotin (EV) 1.25 mg/Kg Q1Wx3 EV Benchmark 100% 100% 100% 100% CRB-701 1.2 mg/Kg Q3W Matched ADC dose 78% 105% 33% 29% 2.7 mg/Kg Q3W Matched for MMAE dose (DAR) 190% 223% 67% 72% 3.6 mg/Kg Q3W 2.9-fold EV ADC dose 245% 333% 61% 75% 4.5 mg/Kg Q3W 3.6-fold EV ADC dose 287% 440% 62% 64%

ASCO 2024 Update: Phase 1 Dose Escalation Disease Responses Two of seven PRs are unconfirmed 2 previous unconfirmed PRs at ASCO GU-2024 now confirmed

ASCO 2024 Update: Disease Response-mUC & Cervical ≥ 1.2 mg/kg ORR: 43% (3 of 7 PRs) DCR: 86% ORR: 44% (4 of 9 PRs) DCR: 78% % Change by RECIST criteria

ASCO 2024 Update: Swimmer Plots

ASCO 2024 Update: Phase 1 Summary Data Objective Response Rate in mUC at doses ≥ 1.2 mg/KG 44%: 4 out of 9 patients with PRs (1 unconfirmed, DCR-78%) Objective Response Rate in Cervical at doses≥ 1.2mg/KG 43%: 3 out of 7 patients with PRs(1 unconfirmed, DCR-86%) Dose for first observed SD 0.2 mg/Kg Dose for first observed PR 1.2 mg/Kg Longest observed response duration to-date 24 weeks for longest Partial Response=8 cycles 51 weeks for longest Stable Disease=17 cycles Participants still on CRB-701 21/37 (57%) First two expansion doses chosen 2.7 and 3.6 mg/Kg (cohorts 5 and 6)

CRB-701: A Differentiated Clinical Development Approach to Competitors Proprietary insights are driving indication selection for CRB-701 New reality of Padcev® + Keytruda® 1L therapy Under-served niche mUC populations remain and are attractive targets Emerging clinical data from current dose escalation is informative Focus on unexplored Nectin-4 solid tumors Non-UC Nectin-4 solid tumors mUC

CRB-701-01 Study Design (Corbus) Dose escalation (Dosing underway) Project Optimus (dose optimization) Dose expansion at RP2D Randomized to 2 doses of CRB-701 monotherapy Randomized to 2 doses of CRB-701 +CPI 1.8 mg/Kg 2.7 mg/Kg 3.6 mg/Kg 4.5 mg/Kg Bladder cancer niche population(s) Non-UC tumors: A B C Basket of nectin-4 positive tumors

Validation of Nectin-4 as a Tumor Associated Antigen beyond mUC References: 1. https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.6017 2. Efficacy and safety of 9MW2821, an antibody-drug conjugate targeting Nectin-4, monotherapy in patients with recurrent or metastatic cervical cancer: A multicenter, open-label, phase I/II study. SGO 2024 –source www.mabwell.com 3. NDA/BLA Multi-disciplinary review and Evaluation – BLA 761137 Parameter Patients (N=46) Patients (N=37) Confirmed ORR 11 (23.9%) 15 (40.5%) CR 1 (2.2%) 1 (2.7%) PR 10 (21.7%) 14 (37.9%) DCR 26 (55%) 33 (89.2%) PFS 3.94 months Too early Neutropenia (Grade 3+4) 4.3% 40% Skin Rash All grades: 45.7% Grade 3+4: 17.5% All grade 3+4 AEs Not disclosed 70% Elevated Nectin-4 expression: urothelial, breast, ovarian, cervical, colorectal, rectal, esophageal, gastric, lung, thyroid, prostate, cholangiocarcinoma, pancreatic cancer, testicular cancer <- Other highly expressing tumors -> UC H&NSCC (1) Cervical (2) March 2024 EV monotherapy 2019 FDA review (3) Patients (N=310) 1.25mg/kg Skin rash (grade 3+4) 10% Any Grade 3-4 TEAE 58% June 2023

ASCO-2024 Expected Q4-2024 Expected Q1-2025 Expected Milestones Q1-2024 First patient dosed in U.S. dose escalation study Clinical data update on China dose escalation study Complete U.S. dose escalation study Present U.S. dose escalation data

CRB-701: Summary Emerging clinical safety appears differentiated to PADCEV Clinical activity seen in mUC and cervical cancer patients 3rd generation ADC with improved linker stability, reduces MMAE in circulation

CRB-913 Oral cannabinoid Type-1 inverse agonist for superior incretin therapy in obesity

The obesity landscape is evolving to address these issues Degree of weight loss  Quality of weight loss Muscle loss Accessibility Injectables  Oral small molecules Tolerability Single MOA  Multiple orthogonal MOAs

The Return of a Clinically-Validated Obesity Drug Class CB1 Inverse Agonism

Source(s): Targeting the endocannabinoid system in diabesity: Fact or fiction?, Drug Discovery Today, Deeba et al. Mar 2021. CB1 is a Well Understood Receptor in Metabolism >9K papers in PubMed on CB1 and metabolism

The CB1 MOA is Clinically Validated in Obesity: Data From 1st Gen Drugs Source(s): 1. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia, Després et al, NEJM, Nov 2005. RIO-Lipids Phase 3 study Placebo (n=342); 5 mg rimonabant (n=345); 20 mg rimonabant (n=346) Rimonabant1 -9.0% -4.4% -2.4% % weight loss

Body composition was measured with body DEXA in a subset of patients in RIO Lipids. Decreases in the rimonabant 20 mg group relative to placebo were observed in the total body mass (p<0.001), the total body fat mass (p=0.001) and the fat mass/total body mass ratio (p=0.007). There was no statistically significant difference between the 20 mg and the placebo groups in lean mass loss between groups. Total body mass Total fat mass Fat mass/body mass Lean mass Rimonabant vs. placebo Unchanged Phase 3 RIO study DEXA-scanned subgroup (n=146) Rimonabant Weight Loss was Not Associated With Reduction of Lean Mass in Obese Patients Rimonabant NDA (page 21)

Muscle-cb1 KO Leads to Increase In Muscle Mass in Obese Mice (Gonzalez-Mariscal et al, 2019) Key finding: Muscle-CB1 KO mice… Increase in muscle mass and strength Increase in biomarkers of muscle growth Increase in mitochondrial metabolism Increase in energy expenditure Increase in calorie consumption w/o weight gain Increase in fat metabolism Enhanced insulin sensitivity in muscle tissue Reduction in body fat content Reduction in sleep

INV-202 CRB-913 Next Generation CB1 Inverse Agonists are Peripherally Restricted Rimonabant Otenabant Ibipinabant Taranabant Source(s): Cinar et al 2020 First generation (2000-2007) Next generation (2020 onwards) Designed to target the brain with high BBB penetration  FDA rejection due to safety concerns (2007) Designed to be peripherally restricted with minimal BBB penetration  avoid safety issues

Single-dose INV-202 (25mg QD) N = 37 Adults with metabolic syndrome Weight loss in 28 days: -3.50 kg (INV-202) vs +0.55Kg (placebo) INV-202 (Inversago) a.k.a Monlunabant (Novo) a.k.a MRI-1891(NIH) Aug. 10, 2023 Novo Nordisk Acquisition of Inversago Marks Return of CB1 as an MOA in Obesity Source(s): Inversago corporate presentation and Despres et al 2023 Novo acquires Inversago for up to $1 billion, spotlighting troubled weight loss approach

Source: TD Cowen Research Report, May 8, 2024 by Michael Nedelcovych “Novo has modeled the weight loss achieved in Phase I and expects to see 16-19% weight loss with single agent Monlunabant at a mature time point (Phase Il obesity results anticipated in H2).” Monulabant (INV-202) Data Predicted for H2 2024

How can a CB1 Inverse Agonist Achieve 16-19% Weight Loss? Source(s): Inversago corporate presentation Monlunabant phase 2 study: ClinicalTrials.gov ID: NCT05891834 Standard obesity endpoints + DEXA scan Standard inclusion and exclusion criteria Monlunabant daily dosing for 16 weeks:50 mg tablet=2.5X Rimonabant dose Placebo 5 mg 20 mg ? RIO-Lipids Phase 3 study Placebo (n=342); 5 mg rimonabant (n=345); 20 mg rimonabant (n=346) Rimonabant1 Placebo 10 mg 20 mg 50 mg Projected efficacy?

Nov. 2023 CRB-913: Oral CB1 Inverse Agonist for Combination Therapy with Incretins

Design Goals CRB-913: Designed to be a Best-in-class Next Generation CB1 Inverse Agonist Best-in-class peripheral restriction Protect lean mass (muscle) Retain 1st gen efficacy Enhance efficacy of incretin analogs

Ibipinabant (2004-2008) JD-5037 (2012-2018) / CRB-4001 (2018-2021) Completed Phase IIb (Solvay/BMS) Small, lipid soluble molecule High BBB penetration Oral Same backbone as Inversago compounds (MRI/INV family) CRB-4001 (JD5037) licensed from Jenrin in 2018 Extensive pre-IND studies carried out PK didn’t support TPP Oral CRB-913 New IP published – patent coverage through 2043 PK profile optimized for TPP Favorable multi-species bioavailability (>50%) Lower mfg. cost vs. incretins Oral CRB-913 is the Outcome of a Multi-year Medicinal Chemistry Campaign

Source(s): Morningstar et al 2023 CRB-913: Marked ↓ Brain and ↑ Peripheral Exposure Vs. Rimonabant in Both Lean and Obese Mice 10 mg/Kg Co-administration with incretin analog does not affect brain penetration for CRB-913

Source(s): *Morningstar et al 2023 and **Liu et al 2021 Brain concentration (ng/g) single acute dose CRB-913 (lean mice) Monlunabant (lean mice) Rimonabant (lean mice) 10 mg/Kg 26* 319** 561* 1:12 1:21 CRB-913: Higher Degree of Peripheral Restriction than Monlunabant or Rimonabant

Source(s): Morningstar et al 2023 CRB-913: Similar Weight Loss vs. Rimonabant at Same Daily Doses in DIO Mice

21-fold DIO mouse model (day 28) DIO mouse model with C57BL6/N mice (n=10) fed a continuous high fat diet for 22 weeks prior and during 28 days of treatment Brain collected 1 h post final dose (Cmax) Source(s): Company data on file. CRB-913: Similar Weight Loss Despite Markedly Lower Brain Concentrations vs. Rimonabant

weight (g) Body Fat Lean Mass CRB-913 Demonstrates Significant Reduction in Body Fat Content but Not Lean Mass DIO mouse model with C57BL6/J mice (n=10) fed a continuous high fat diet for 22 weeks prior Body fat by MRI determined on Day 20 Source(s): Morningstar et al 2023

CRB-913: Enhanced Combo Effect with Semaglutide Or Tirzepatide Source(s): Company data on file. DIO mouse model with C57BL6/J mice (n=10) fed a continuous high fat diet for 22 weeks prior and during 18 days of treatment (Similar effect also seen when CRB-913 was combined with liraglutide) Body weight change (%) at day 18 All cohorts P < 0.001 compared with vehicle 5.2

Food Consumption CRB-913, semaglutide and tirzepatide each results in food intake reductions Significant further reductions in food consumption when CRB-913 is combined with semaglutide or tirzepatide (p=0.001) All cohorts P < 0.001 compared with vehicle DIO mouse model with C57BL6/J mice (n=10) fed a continuous high fat diet for 22 weeks prior CRB-913 Reduces Food Consumption Alone or in Combination with Semaglutide or Tirzepatide

CRB-913 Reverses Leptinemia Alone and in Combination with Semaglutide or Tirzepatide Source(s): 1 Leptin and the maintenance of elevated body weight, Pan and Myers, Nature Reviews, Jan 2018. Company data on file. The Role of Leptin The hormone leptin regulates food intake Normally, leptin signals satiety (feeling “full”) In obesity, resistance to leptin develops and hunger persists despite high leptin levels (“leptinemia”) A reduction in leptin levels is believed to be important for weight loss1 DIO mouse model with C57BL6/J mice (n=10) fed a continuous high fat diet for 22 weeks prior Leptin measured at Day 28 of treatment All cohorts P < 0.001 compared with vehicle

vehicle CRB-913 (2.5 mg/kg) semaglutide (10 nmol/kg) CRB-913 (2.5 mg/kg) + semaglutide (10 nmol/kg) tirzepatide (5 nmol/kg) CRB-913 (2.5 mg/kg) + tirzepatide (5 nmol/kg) Liver fat CRB-913 Reduces Liver Fat Alone and in Combination with Semaglutide or Tirzepatide *liver oil red stain Source(s): Company data on file.

CRB-913: Clinical Development Pathway Q4 2024 H1 2025 H2 ‘25 – H1 ‘26 H2 ‘26 – H1 ‘27 SAD  MAD IND Monotherapy 28 days (3 doses) Co-admin with incretin analog

CRB-913: Potential Clinical Usage Incretin analog therapy for insensitive/intolerant/high-risk patients Combination with oral incretin agonists  potentially enhances efficacy OR improve tolerability “Induction/maintenance” model: goal to potentially maintain weight loss post incretin analog therapy Implications of a 2nd gen CB1 inverse agonist that could deliver 16%-19% weight loss Potential equivalent weight loss to semaglutide or even tirzepatide Monotherapy Once-a-day pill No need for titration

Expected Milestones Produce drug for toxicology and clinical studies Q2-2024 Complete toxicology and IND enabling studies Q4-2024 FPI SAD/MAD Q1-2025

LeadershipUpcoming CatalystsFinancials

Management Team Sean Moran, CPA, MBA Chief Financial Ofﬁcer Corbus co-founder and Chief Financial Officer since 2014. Prior senior financial management experience in emerging biotech and medical device companies. Christina Bertsch Head of Human Resources Accomplished senior human resource executive with extensive experience in human resources and recruiting. Yuval Cohen, PhD Chief Executive Ofﬁcer, Director Corbus co-founder and Chief Executive Officer since 2014. Previously the President and co-founder of Celsus Therapeutics from 2005. Dominic Smethurst, PhD Chief Medical Officer, MA MRCP Dr. Smethurst, MA MRCP, joined Corbus as our Chief Medical Officer in February 2024. He most recently served as CMO of Bicycle Therapeutics.

Board of Directors Amb. Alan Holmer Ret. Chairman of the Board More than two decades of public service in Washington, D.C. including Special Envoy to China; Former CEO of PhRMA. Avery W. (Chip) Catlin Director More than 25 years of senior ﬁnancial leadership experience in life science companies; Former CFO and Secretary of Celldex Therapeutics. Yuval Cohen, PhD Chief Executive Ofﬁcer, Director Corbus co-founder and Chief Executive Officer since 2014. Previously the President and co-founder of Celsus Therapeutics from 2005. Anne Altmeyer, PhD, MBA, MPH Director 20 years of experience advancing oncology R&D programs and leading impactful corporate development transactions; currently President & CEO of TigaTx. Yong (Ben) Ben, MD, MBA Director 25 years of oncology R&D experience across industry and academia. Held two industry CMO positions, most recently at BeiGene (BGNE). Rachelle Jacques Director More than 25-year professional career, experience in U.S. and global biopharmaceutical commercial leadership, including multiple high-proﬁle product launches in rare diseases; Former CEO of Akari Therapeutics. (NASDAQ: AKTX) John K. Jenkins, MD Director Distinguished 25-year career serving at the U.S. FDA, including 15 years of senior leadership in CDER and OND. Pete Salzmann, MD, MBA Director 20 years of industry experience and currently serves as Chief Executive Ofﬁcer of Immunovant (NASDAQ: IMVT), a biopharmaceutical company focused on developing therapies for patients with autoimmune diseases.

Expected Corporate Milestones First patient dosed: Summer 2024 First patient dosed: early 2025 Complete U.S. dose escalation study: Q4 2024 Present U.S. dose escalation data: Q1-2025 CRB - 701 CRB-913 CRB-601

Investment Summary $120M Cash, cash equivalents and investments as of March 31, 2024 and 10.5M Common Shares Outstanding (11.6M Fully-Diluted Shares) Nectin-4 targeting ADC for treatment of solid tumors Oral CB1R inverse agonist to treat obesity TGFβ blocker Anti-⍺vβ8 integrin mAb for treatment of solid tumors CRB-913 CRB-601 CRB-701

Connecting Innovation to Purpose NASDAQ: CRBP Corporate Presentation

Appendix

CRB-601Potential “best-in-class” ⍺vβ8 mAb

CRB-601 has the Potential to Enhance Checkpoint Inhibition Focus on adopting a precision-targeted approach Novel mechanism to target TGFb in the tumor microenvironment Large opportunity potential if POC is validated

TGFβ predicts poor clinical outcomes in a subset of cancer patients 0 25 20 15 10 5 0.0 0.2 0.4 0.6 0.8 1.0 N = 8,461 cancers, multiple cell types Time (years) Overall survival, % Immunogenomic subtypes in cancer Source(s): Thorsson, et al. The Immune Landscape of Cancer, Immunity. 2018; 48:817 C1 C2 C3 C4 C5 C6 WOUND HEALING INF-γ DOMINANT INFLAMMATORY LYMPHOCYTE DEPLETED IMMUNOLOGICALLY QUIET TGFβ DOMINANT TGFβ predominance gene signature Gene expression, immune cell quantification & network mapping 33 different cancer types / 8,000+ tumors

Targeting the Integrin ⍺Vβ8 Represents a Novel Approach to Regulating TGFβ Source(s): Huang et al., 2021. Recent progress in TGFβ inhibitors for cancer therapy.

CRB-601 is Targeting Latent -TGFβ by Blocking the Integrin avb8 The integrin avb8 is expressed in the tumor microenvironment (TME) Latent-TGFb is also expressedin the TME CRB-601 is a blocking antibody preventing the interaction of these two proteins

mAbs targeting TGFβ Activation are Advancing clinically Source(s): Company websites. Clinicaltrials.gov. Internal analysis. CRB-601 PF-06940434 SRK-181 ABBV-151 RG6440 MOA ⍺vβ8 ⍺vβ8 L-TGFβ GARP(TGFβ1) L-TGFβ Clinical Stage IND Cleared Jan 24 Phase 1/2 Phase 1 Phase 2 Phase 1 Indications Solid Tumors Solid Tumors Solid Tumors HCC Solid Tumors Type Monoclonal Antibody Monoclonal Antibody Monoclonal Antibody Monoclonal Antibody Monoclonal Antibody ROA IV IV IV IV IV

CRB-601 Enhances Anti-PD-1 Therapy in Checkpoint Inhibition Sensitiveand Resistant Murine Tumor Models CRB-601: 10 mg/kg BIW Anti-PD-1: 10 mg/kg BIW 10 animals / group Animals randomized at 50-80 mm3 Comparisons across arms *p<0.05, ***p<0.001, ****p<0.0001 % TGI MC38 EMT6 4T1 Anti-PD-1 54 -8 6 CRB-601 46 37 10 Combo 89 65 41 Resistant Checkpoint blockade sensitivity Sensitive MC38 (Inflamed Tumor) EMT6 (Excluded Tumor) 4T1 (Desert Tumor) *** **** **** *** * *** *** *** * Source(s): Corbus data on file

Blockade of ⍺vβ8 in Combination with anti-PD-1 Increased TIL Populations in Immune Excluded EMT6 Tumors Source(s): Corbus data on file **** *** **** **** **** *** **** **** Ki67+CD4 T Cells Ki67+CD8 T Cells CD4 T Cells CD8 T Cells Tumor Size * *** * **** ** *** ** *** ** **** * **** * Treatment Days -14 0 3 6 10 Anti-PD-1, 10 mg/kg, IP CRB-601, 30 mg/kg, IP EMT6 orthotopic implantation PD readouts Tumor volume = 200 mm3 (when treatment initiated) *p<0.05; **p<0.01; ***p<0.001; ****p<0.0001 M1/M2 Ratio NK Cells ** ** **** **** * *

CRB-601 Reshapes The Landscape Of Effector T and NK Cells in MC38 Tumors Source(s): Corbus data on file

Applying a Proprietary Algorithm To Define The Clinical Focus for CRB-601 A multi-parametric, immune-focused algorithm has refined indications forCRB-601 The combination of immune features and gene expression profiles have identified9 indications for clinical priority High Low Quartiles Source(s): Corbus proprietary analysis Clustered Tumor Types

Patient Selection Strategies Will Enhance the Probability of Success Source(s): Corbus proprietary analysis: Log2 fold change of Nectin-4 expression as a ratio to normal tissue Controls Ovarian Melanoma Breast Colon Prioritization of indications with differential gene expression vs. normal tissues will emphasize focus on the tumor potential of ⍺vβ8 Development of a NEW patient enrichment biomarker will assist in enriching for responses and addressing the right immune resistant patient population with CRB-601 Tumor Types (redacted)

Expected Milestones IND cleared January 2024 First patient dosed Summer 2024 Dose escalation and confirmation 2nd Half of 2024

Document And Entity Information	Jun. 01, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jun. 01, 2024
Entity Registrant Name	CORBUS PHARMACEUTICALS HOLDINGS, INC.
Entity Central Index Key	0001595097
Entity Emerging Growth Company	false
Entity File Number	001-37348
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-4348039
Entity Address, Address Line One	500 River Ridge Drive
Entity Address, City or Town	Norwood
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02062
City Area Code	(617)
Local Phone Number	963-0100
Entity Information, Former Legal or Registered Name	Not Applicable
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	CRBP
Security Exchange Name	NONE