8-K
false0001595097NONE00015950972023-03-032023-03-03

 

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): March 03, 2023

 

 

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 2.02 Results of Operations and Financial Condition.

Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release on March 7, 2023, disclosing financial information and operating metrics for its fiscal year ended December 31, 2022 and discussing its business outlook. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 3, 2023, Craig Millian, Chief Operating Officer of the Company, submitted a notice of resignation to the Company to pursue other opportunities. Mr. Millian’s last day of employment with the Company will be April 14, 2023. In connection with his departure, the Company and Mr. Millian intend to enter into a separation agreement, the terms of which will be disclosed in an amendment to this Current Report on Form 8-K.

Item 7.01 Regulation FD Disclosure.

See “Item 2.02 Results of Operations and Financial Condition” above.

 

The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 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 or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.

Item 8.01 Other Events.

The Company is using the slides attached hereto as Exhibit 99.2 to this Current Report on Form 8-K in connection with management presentations to describe its business.

Item 9.01 Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Corbus Pharmaceuticals Holdings, Inc. dated March 7, 2023

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 thereunto duly authorized.

 

 

 

Corbus Pharmaceuticals Holdings, Inc.

 

 

 

 

Date:

March 7, 2023

By:

/s/ Yuval Cohen

 

 

 

Name: Yuval Cohen
Title: Chief Executive Officer

 


 

Exhibit 99.1

Corbus Pharmaceuticals Reports Fourth Quarter 2022 and Year-End Financial Results and Provides Corporate Update

Company expands precision oncology pipeline with licensing of CRB-701, clinical-stage Nectin-4 antibody drug conjugate (ADC) from CSPC Pharmaceutical Group

 

CRB-701 Phase 1 dose escalation ongoing in China in patients with advanced solid tumors

 

CRB-601 anti-αvβ8 mAb program scheduled for IND submission in the second half of 2023
CRB-601 continues to demonstrate compelling pre-clinical monotherapy and combination data with anti-PD-1
Dr. Yong Ben, distinguished oncology researcher joins the Corbus Board of Directors

 

Norwood, MA, March 7, 2023 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2022.

 

“The fourth quarter and recent weeks have been a productive period for Corbus as we continue to evolve into a precision oncology company,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “With the execution of our exclusive licensing agreement for CRB-701, a next generation Nectin-4 ADC, we are excited to have a compelling, differentiated asset in the clinic. Concurrently, we continue on-track to the clinic with CRB-601 supported by our latest pre-clinical data presented at SITC 2022”.

 

Key Corporate and Program Updates:

CRB-701 next generation Nectin-4 ADC
o
Acquired CRB-701 through licensing agreement with CSPC Pharmaceutical Group granting exclusive development and commercialization rights in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia.
o
CRB-701 is designed to achieve an improved therapeutic index and patient convenience and could act on a broad range of Nectin-4 expressing tumors.
o
Clinical development is underway and will focus on urothelial cancer and other Nectin-4-positive solid tumors potentially including lung, breast and prostate cancer.
CRB-601 blocking the activation of TGFβ
o
CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody designed to block the activation of latent TGFβ within the tumor microenvironment.

o
CRB-601 significantly inhibits tumor growth as a single agent and enhances the efficacy of anti-PD-1 immunotherapy in checkpoint inhibitor (CPI) sensitive and CPI-resistant tumor models.
o
Pre-clinical data presented at SITC 2022 indicate that anti-tumor activity of CRB-601 as a monotherapy correlates with protein expression of αvβ8. CRB-601 is scheduled for IND submission in the second half of 2023 in solid tumor cancer patients with the first patient treated by the end of 2023.
Additions to the Board and Management Changes
o
Dr. Yong Ben joined the Corbus Board of Directors on March 1, 2023. Dr Ben is a distinguished oncology researcher and pharma industry executive, with multiple drug approvals to his credit. This appointment augments our Board with his extensive oncology experience both in the United States and China.
o
Craig Millian, the Company’s Chief Operating Officer, will be departing Corbus on April 14, 2023 to pursue other opportunities. “We are very grateful for Craig’s contributions over the past four years. We thank him for his efforts and leadership and wish him well in his future endeavors”, stated Yuval Cohen Ph.D., Chief Executive Officer of Corbus.

 

Financial Results for Fourth Quarter Ended December 31, 2022:

The Company reported a net loss of approximately $10.9 million, or a net loss per diluted share of $2.61, for the three months ended December 31, 2022, compared to a net loss of approximately $10.3 million, or a net loss per diluted share of $2.46, for the same period in 2021. For the year ended December 31, 2022, the Company reported a net loss of approximately $42.3 million, or a net loss per diluted share of $10.15, compared to a net loss of approximately $45.6 million, or a net loss per diluted share of $11.15 for the same period in 2021.


Operating expenses for Q4 2022 increased by $0.8 million to approximately $10.8 million for the three months ended December 31, 2022, compared to $10.0 million in the comparable period in the prior year. The increase was primarily attributable to pre-clinical costs to support IND filing for CRB-601 offset by decreased clinical trial and drug manufacturing costs, as well as an overall reduction in compensation expense. A reverse stock split of 1-for-30 was effected on February 14, 2023 and all per share amounts except the authorized shares have been retroactively adjusted to reflect the reverse split.

 

As of December 31, 2022, the Company has $59.2 million of cash and investments on hand which is expected to fund operations through the second quarter of 2024, based on the current planned expenditures.

 

About Corbus

 

Corbus Pharmaceuticals Holdings, Inc. (the “Company” or “Corbus”) is a precision oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload and CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells. 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 restructuring, trial results, product development, clinical and regulatory timelines, 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, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, 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.

 

 

 

INVESTOR CONTACT:

Sean Moran

Chief Financial Officer

[email protected]

 

Bruce Mackle
Managing Director
LifeSci Advisors, LLC
[email protected]

 

---tables to follow---

 


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

 

 

(Unaudited)

For the Three Months
Ended December 31,

 

 

For the Twelve Months
Ended December 31,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue from awards

$

 

 

$

 

 

$

 

 

$

881,705

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

6,242,758

 

 

 

5,763,601

 

 

 

16,136,826

 

 

 

36,445,285

 

General and administrative

 

4,554,062

 

 

 

4,234,760

 

 

 

18,698,619

 

 

 

20,425,444

 

Litigation Settlement

 

 

 

 

 

 

 

5,000,000

 

 

 

 

Total operating expenses

 

10,796,820

 

 

 

9,998,361

 

 

 

39,835,445

 

 

 

56,870,729

 

Operating loss

 

(10,796,820

)

 

 

(9,998,361

)

 

 

(39,835,445

)

 

 

(55,989,024

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

275,549

 

 

 

109,664

 

 

 

(48,773

)

 

 

11,899,992

 

Interest income (expense), net

 

(640,954

)

 

 

(390,899

)

 

 

(2,132,091

)

 

 

(1,830,486

)

Change in fair value of derivative liability

 

96,842

 

 

 

(6,853

)

 

 

96,842

 

 

 

663,290

 

Foreign currency exchange gain (loss), net

 

186,330

 

 

 

25,716

 

 

 

(427,436

)

 

 

(384,198

)

Other income (expense), net

 

(82,233

)

 

 

(262,372

)

 

 

(2,511,458

)

 

 

10,348,598

 

Net loss

$

(10,879,053

)

 

$

(10,260,733

)

 

$

(42,346,903

)

 

$

(45,640,426

)

Net loss per share, basic and diluted

$

(2.61

)

 

$

(2.46

)

 

$

(10.15

)

 

$

(11.15

)

Weighted average number of common shares outstanding, basic and diluted

 

4,171,297

 

 

 

4,169,631

 

 

 

4,170,675

 

 

 

4,094,935

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(10,879,053

)

 

$

(10,260,733

)

 

$

(42,346,903

)

 

$

(45,640,426

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized gain (loss) on marketable debt securities

 

80,782

 

 

 

(53,478

)

 

 

(63,647

)

 

 

(62,445

)

Total other comprehensive income (loss)

 

80,782

 

 

 

(53,478

)

 

 

(63,647

)

 

 

(62,445

)

Total comprehensive loss

$

(10,798,271

)

 

$

(10,314,211

)

 

$

(42,410,550

)

 

$

(45,702,871

)

 

 


Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets

 

 

 

December 31, 2022

 

 

December 31, 2021

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

17,002,715

 

 

$

25,006,632

 

Investments

 

 

42,194,296

 

 

 

72,640,520

 

Restricted cash

 

 

192,475

 

 

 

192,475

 

Prepaid expenses and other current assets

 

 

791,616

 

 

 

2,365,010

 

Total current assets

 

 

60,181,102

 

 

 

100,204,637

 

Restricted cash

 

 

477,425

 

 

 

477,425

 

Property and equipment, net

 

 

1,613,815

 

 

 

2,392,696

 

Operating lease right of use assets

 

 

3,884,252

 

 

 

4,609,110

 

Other assets

 

 

155,346

 

 

 

46,385

 

Total assets

 

$

66,311,940

 

 

$

107,730,253

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Notes payable

 

$

353,323

 

 

$

767,938

 

Accounts payable

 

 

2,173,963

 

 

 

1,782,277

 

Accrued expenses

 

 

5,999,252

 

 

 

10,093,312

 

Derivative liability

 

 

36,868

 

 

 

133,710

 

Operating lease liabilities, current

 

 

1,280,863

 

 

 

1,136,948

 

Current portion of long-term debt

 

 

2,795,669

 

 

 

3,093,344

 

Total current liabilities

 

 

12,639,938

 

 

 

17,007,529

 

Long-term debt, net of debt discount

 

 

15,984,426

 

 

 

15,636,275

 

Other long-term liabilities

 

 

22,205

 

 

 

22,205

 

Operating lease liabilities, noncurrent

 

 

4,675,354

 

 

 

5,956,217

 

Total liabilities

 

 

33,321,923

 

 

 

38,622,226

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares
   issued and outstanding at December 31, 2022 and December 31, 2021. See Note 13

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized,
   4,171,297 and 4,169,631 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively

 

 

417

 

 

 

416

 

Additional paid-in capital

 

 

425,196,359

 

 

 

418,903,820

 

Accumulated deficit

 

 

(392,080,667

)

 

 

(349,733,764

)

Accumulated other comprehensive loss

 

 

(126,092

)

 

 

(62,445

)

Total stockholders’ equity

 

 

32,990,017

 

 

 

69,108,027

 

Total liabilities and stockholders’ equity

 

$

66,311,940

 

 

$

107,730,253

 

 


Slide 1

Connecting Innovation to Purpose Corporate Presentation March 2023 NASDAQ: CRBP • CorbusPharma.com • @CorbusPharma Exhibit 99.2


Slide 2

Forward-Looking Statements 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 restructuring, trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities 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, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, 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.


Slide 3

Introducing the new Corbus Pharmaceuticals Norwood, MA (Boston area) NASDAQ: CRBP Precision oncology + differentiated assets Established targets  enhance probability of success Multiple catalysts in 2023 – 2024


Slide 4

Compound Indications Preclinical Phase 1 Phase 2 Phase 3 Next Generation Nectin-4 targeting ADC CRB-701 Next generation Nectin-4 targeting ADC Urothelial cancer Nectin-4 enriched solid tumors Anti-Integrin mAb CRB-601 Anti-⍺vβ8 mAb (TGFβ-targeting) ⍺vβ8 enriched solid tumors IND H2 2023 First Patient Q4 2023 A diversified pipeline with different risk profiles Ongoing (China) Starts 2024 (US and China)


Slide 5

CRB-701 Next Gen Nectin-4 Targeting ADC


Slide 6

Nectin-4 is a clinically validated target with untapped potential Cell adhesion molecule important in adherence junction formation Ligand of TIGIT, known to inhibit NK cell activity Tumor-associated antigen (TAA) with a restricted distribution in normal tissue and overexpression in multiple tumors SeaGen/Astellas PADCEV®: only approved Nectin-4 ADC (in urothelial cancer) but has safety limitations Source(s): (Licensed permission) Heath, E.I., Rosenberg, J.E. The biology and rationale of targeting Nectin-4 in urothelial carcinoma. Nat Rev Urol 18, 93–103 (2021). *Drug-to-antibody ratio Improve therapeutic index in urothelial cancer 1 Expansion beyond urothelial cancer 2 Opportunities for a novel ADC Nectin-4


Slide 7

PADCEV® projected to reach up to ~$5B in global sales by 2028 Late-stage Clinical Development Source(s): SeaGen website, Evaluate Ltd $5B 1Projected revenues for UC/Bladder only Indications Phase 1 Phase 2 Phase 3 Approved 2L+ Urothelial Cancer (UC) Monotherapy 1L Urothelial Cancer + pembrolizumab Muscle-invasive Bladder Cancer (MIBC) + pembrolizumab Advanced Solid Tumors Monotherapy ®


Slide 8

PADCEV® safety limitations impact tolerability and dose intensity A Black Box warning for PADCEV ® cautions physicians regarding the skin toxicity risk1 PADCEV® monotherapy1 PADCEV® + pembrolizumab2 Skin Reactions 55% 67% Peripheral Neuropathy 52% 61% PADCEV® Adverse Events (% of patients) Source(s): 1. PADCEV® Prescribing Information. 2. 2022 ESMO, LBA73 - Study EV-103 Cohort K. 3. Rosenberg et al., 2020, JCO April 1 38 (10) . Greater than 25% of PADCEV® discontinuations are linked to peripheral neuropathy 3 ®


Slide 9

CRB-701 CRB-701: next generation site-specific Nectin-4 targeting ADC CRB-701 Mechanism of CRB-701 ADC  Selective binding of CRB-701 to Nectin-4 Internalization of CRB-701/Nectin-4 complex via endocytosis Intracellular cytosol release of MMAE (payload) due to lysosomal trafficking MMAE cytotoxic effect – tubulin polymerization inhibition – G2/M cell cycle arrest - apoptosis Bystander effect: Nearby tumor cells exposed to MMAE/ADC released from targeted cell also undergo apoptosis Source(s): Modified image from Corbus data on file (SYS6002) MMAE = Monomethyl auristatin E ADCC = antibody-dependent cellular cytotoxicity CDC = complement dependent cytotoxicity


Slide 10

CRB-701 is designed to be an improved Nectin-4 targeting ADC Novel antibody Comparable affinity and selectivity to the antibody in current SOC but proprietary CDRs. CRB-701 has ADCC / CDC functionality. Potential for retreatment in PADCEV® intolerant patients. Designed for improved therapeutic index Site specific conjugation and novel linker technology enables homogenous payload incorporation & release. High plasma stability and low free plasma payload. Simpler manufacturing Single enzyme, KLICK™ linker chemistry with modification of a native antibody  simpler and cheaper CMC Preferred dosing Long half-life & low free plasma payload supports low frequency dosing vs. PADCEV® once-weekly dosing Source(s): Corbus data on file ADCC = antibody-dependent cellular cytotoxicity CDC = complement dependent cytotoxicity CDR = complementarity-determining region CMC = chemistry, manufacturing and controls


Slide 11

CRB-701 demonstrates potent monotherapy in diverse tumors Comparison of in-vivo pharmacology Prostate Cancer Triple Negative Breast Cancer P *** 0.001; ** 0.01; * 0.1 If improved therapeutic index is demonstrated clinically then the potential to see both a higher dose & greater efficacy exist ** ** *** *** *** *** CRB-701 in PC-3 – Nectin-4 (Nectin-4 overexpression) CRB-701 in MDA-MB-468 (Nectin-4 low/mid) SOC SOC Source(s): Corbus data on file


Slide 12

CRB-701: preclinical data suggests a differentiated Nectin-4 targeting ADC Longer half-life of the ADC and lower plasma concentration of payload Preferentially delivers payload to the tumor vs. plasma Better efficacy in Nectin-4 low expressing urothelial tumors Tumor Growth Inhibition (TGI) @ 3mg/kg in a primary human bladder cancer model (Nectin-4 H score = 50)  CRB-701 SOC 74.5%  (p < 0.05) 53.7% (p = 0.70) Rat Primate Treat tumors with low Nectin-4 expression Demonstrate low toxicity due to free payload Enhance efficacy by greater tumor delivery of payload Comparison of ADC and payload concentrations in tumor vs. plasma (tumor / serum ratio AUC 0-t ) Source(s): Corbus data on file MMAE = monomethyl auristatin E SOC = standard of care There is 164X more MMAE released in the tumor vs the blood reducing risk of toxicity 164X 0.5X Potential to: 55X 7X ADC @ Day 7 2.5X 5X Payload (Cmax) Compared to SOC ADC is present for longer than 7 days Less payload in plasma


Slide 13

CRB-701: differentiated by immune-mediated tumor destruction functionality The CRB-701 antibody has built-in Fc receptor binding activity  innate immune mediated tumor destruction CRB-701 has demonstrated potency against FcγR1, C1q and FcRn This additional antibody functionality is designed to increase efficacy of CRB-701 via a secondary mechanism CRB-701 Antibody-dependent cellular cytotoxicity (ADCC) < 1 nM CRB-701 Complement-dependent cytotoxicity (CDC) < 10 nM Source(s): Corbus data on file ADCC = antibody-dependent cellular cytotoxicity CDC = complement dependent cytotoxicity


Slide 14

CRB-701: designed for a differentiated product profile Feature CRB-701* PADCEV® BT8009 MOA ADC  ADC BTC  Clinical Stage Phase 1 (China) Approved Phase 2 Other functionality  ADCC + CDC No ADCC or CDC No ADCC or CDC Payload release Internalization Internalization Can release without internalization Linker conjugation Site specific Random Random (Seagen similar) / single site conjugation Dosing TBD Low frequency 1.25 mg/kg Days 1, 8, 15 / 28 days 7.5 mg/m2  D1, 8/ 21 days Nectin-4 tumor expression required Active in low and high  Source(s): Company websites, clinicaltrials.gov, European Public Assessment Report of PADCEV® (2022). PADCEV® prescribing information. Rigby et al, BT8009; A Nectin-4 Targeting Bicycle Toxin Conjugate for Treatment of Solid Tumors. Mol Cancer Ther. 2022 Dec 2;21(12):1747-1756. doi: 10.1158/1535-7163.MCT-21-0875.2022. Chu et al., 2021 Clin Cancer Res. Sept 15; 27(18): doi:10.1158/1078-0432.CCR-20-4175. Jain et al, Current ADC Linker Chemistry. Pharm Res. 2015 Nov;32(11):3526-40. doi: 10.1007/s11095-015-1657-7. Center for Drug Evaluation and Research, NDA/BLA Multi-disciplinary Review and Evaluation – BLA 761137 (2019). Corbus data on file. *US and European commercialization rights in-licensed from CSPC Pharmaceutical Group (China) ADCC = antibody-dependent cellular cytotoxicity  CDC = complement dependent cytotoxicity  BTC = Bicycle toxin conjugate  


Slide 15

Urothelial cancer provides the first clinical validation of using a Nectin-4 targeting ADC PADCEV® in urothelial cancer 97% of patients were Nectin-4 positive2 290 avg H-score (range 14 - 300) 2 63% of samples had H-scores ≥ 100 in an independent study 524 patients2 PADCEV® monotherapy1 ORR 44% Complete Response 12% Mean DOR 7.6 months Nectin-4 expression spans beyond urothelial cancer3 UC <---- Other highly expressing tumors ----> Source(s): 1. PADCEV® Prescribing Information. 2. Chu et al., 2021 Clin Cancer Res. Sept 15; 27(18): doi:10.1158/1078-0432.CCR-20-4175. 3. Corbus proprietary analysis: Log2 nectin-4 expression in 10,000 individual tumors (primary data from TCGA) Elevated Nectin-4 expression: urothelial, breast, ovarian, cervical, colorectal, rectal, esophageal, gastric, lung, thyroid, prostate, cholangiocarcinoma, pancreatic cancer, testicular cancer


Slide 16

Response to Padcev® could be tied to expression level of Nectin-4 Response to Padcev® in the EV-201 study expressed as a function of Nectin-4 expression (H-score)1 Source: 1. Multi-Discipline Review. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761137Orig1s000MultiDiscliplineR.pdf. 2. Chang et al., 2021. 10.1158/1078-0432.CCR-20-2275. 3. Campbell et al.,, A multi tumor survey of Nectin-4 expression to guide BT8009 indication selection. 4. Challita-Eid etal., 2016 doi: 10.1158/0008-5472 H-score > 200 Padcev® ORR 47% H-score ≤ 200 Padcev® ORR 15% Protein expression data reveals a trend toward responses in higher H-scores (mostly above 200) Nectin-4 expression (H-score) across tumor microarrays suggests lower expression beyond UC2 Comparison of Nectin-4 expression using two distinct antibodies targeting the ECD of Nectin-43,4


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CRB-701 differentiation + novel development strategy  expansion beyond urothelial cancer CRB-701 Improved therapeutic Companion diagnostic Developing CDx is key to patient selection Indication validation Nonclinical validation of the Nectin-4 receptor will influence indication selection Limited competition Focus on indications outside of the scope of the current competitors CDx = companion diagnostic


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Corbus data analysis points to specific tumors outside current competition Source(s): Corbus proprietary analysis: Log2 fold change of nectin-4 expression as a ratio to normal tissue Differentiation of CRB-701’s approach Selecting tumors with a strong differential Nectin-4 gene expression Uncovering insights re Nectin-4 (recycling & density) in nonclinical systems and primary tumors Creating validation in tumor types that support clinical development beyond the competition Tumor Types (redacted) CRB-701 PADCEV® BT8009 9MW-2821


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CSPC: a top five biopharmaceutical company in China1 HKSE: 1093.HK Market Cap: $15.7B2 2021 Revenue: $4.1B2 # of employees: 23,000+ 864 drug licenses, 68 API licenses 1,363 patent applications among which 772 have been authorized ~300 R&D projects under development, ~100 innovative projects Recent US deals: Flame, Elevation Source(s): 1. GlobalData as of Dec 31, 2022. 2. Yahoo Finance as of Feb 10, 2023. Company websites. CSPC data on file.


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CRB-701 collaboration will leverage CSPC capabilities Translational work on MOA in solid tumors Companion diagnostic validation Clinical bridging study in US using China RP2D (2024) Phase 1b/2 in Nectin-4 enriched solid tumors Dose escalation (underway in China) Urothelial cancer clinical development Companion diagnostic development Clinical drug supply Joint Steering Committee (JSC)


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US activation of CRB-701 is planned in 2024 2023 Q1 2023 Q2 2023 Q3 2023 Q4 2024 Q1 2024 Q2 2024 Q3 2024 Q4 The Corbus development approach will consider: Clinical differentiation Translational validation Companion diagnostic development CRB-701 Development Timeline Non-clinical validation of Nectin-4 China US Candidate companion diagnostic development Dose Escalation FPI Dose Expansion US bridging RP2D US US Source(s): Corbus data on file.


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


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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


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TGFβ TGFβ plays a central role in immunoregulation and cancer Source(s): Dahmani A, Delisle JS. TGF-β in T Cell Biology: Implications for Cancer Immunotherapy. Cancers (Basel). 2018;10(6):194. Published 2018 Jun 11. doi:10.3390/cancers10060194 TGFβ has been associated with immune cell exclusion in cancer Targeting TGFβ has been challenging Local tumor versus systemic signaling may be key Pro-inflammatory Anti-inflammatory Resistant Epithelium Tumor stroma


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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


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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. Novel point of therapeutic intervention Blocking the ⍺vβ8 activation of TGFβ in the local tumor micro environment TGF-β Antibody Ligand Trap


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Significant opportunity in improving response to PD-1 /L1’s 70 - 80% of patients do not respond to PD-1/L1 therapy1 $70B+ in projected PD-1/L1 sales worldwide by 20282 Opportunity to improve response with biomarker-based, precision combos Source(s): Sun, JY., Zhang, D., Wu, S. et al. Resistance to PD-1/PD-L1 blockade cancer immunotherapy: mechanisms, predictive factors, and future perspectives. Biomark Res 8, 35 (2020). Evaluate, January 2023


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TGF-β signaling has a negative association with PD-L1 inhibitor responses clinically Anti PD-1 response in Urothelial cancer (68 responders / 230 non-responders) TGFb1 gene expression nonresponse p = 0.00011 OS (likelihood ratio test) p = 0.0096 Source(s): Mariathasan et al., 2018 Nature. 554(7693): 544–548. doi:10.1038/nature25501. OS (months) Positive Outcomes Negative Outcomes Pre-existing T-cell immunity High TMB An Increase in TGF-β signaling


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Renewed interest in TGFβ via new approaches to prevent activation Source(s): Company websites. Clinicaltrials.gov. Internall analysis. CRB-601 PF-06940434 SRK-181 ABBV-151 PLN-101095 TBD MOA ⍺vβ8 ⍺vβ8 L-TGFβ GARP (TGFβ1) ⍺vβ8/β1 ⍺vβ8 Clinical Stage IND in H2 2023 Phase 1 Phase 1 Phase 1 IND Preclinical Indications Solid Tumors Solid Tumors Solid Tumors Solid Tumors Solid Tumors TBD Type Monoclonal Antibody Monoclonal Antibody Monoclonal Antibody Monoclonal Antibody Small Molecule Small Molecule ROA IV IV IV IV Oral Oral


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CRB-601 enhances anti-PD-1 therapy in checkpoint inhibition sensitive and 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


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Blockade of ⍺vβ8 in combination with anti-PD-1 increased TIL populations in immune excluded EMT6 tumors **** *** **** **** **** *** **** **** 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 ** ** **** **** * * Source(s): Corbus data on file


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Levels of αvβ8 expression on tumor cells are closely related to the antitumor activity of CRB-601 in the same syngeneic models. Corbus data demonstrates the value proposition of enriching patients for response CDx strategy for CRB-601 to increase probability of success Source(s): Corbus data on file CDx = companion diagnostic p values were calculated by t-test. *p <0.05, **p<0.01 TGI % vs. ⍺vβ8 %


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Applying a proprietary algorithm to define the clinical focus for CRB-601 A multi-parametric, immune-focused algorithm has refined indications for CRB-601 The combination of immune features and gene expression profiles have identified 9 indications for clinical priority High Low Quartiles Source(s): Corbus proprietary analysis Clustered Tumor Types


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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)


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CRB-601 Next Steps IND filing scheduled for H2-2023 FPI expected before the end of 2023 Non-clinical validation of a potential patient selection biomarker in 2023 Dose escalation and confirmation will be the focus through 2024


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Upcoming catalysts


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2023 - 2024 Catalysts 2023 Q1 2023 Q2 2023 Q3 2023 Q4 2024 Q1 2024 Q2 2024 Q3 2024 Q4 CRB - 601 ⍺vβ8 mAb CRB - 701 Nectin-4 targeting ADC FPI (China) RP2D (China) RP2D (US) US CDx partnership IND H2 2023 FPI AACR-NCI-EORTC ASCO Clin Pharm TGFβ Summit Trials in Progress AACR ESMO ASCO Trials in Progress Bridging (US) Conference presentation Clinical milestone SITC Non-clinical update PK = pharmacokinetics CDx = companion diagnostic RP2D = recommended phase 2 dose FPI = first patient in  


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Leadership


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Management Team 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 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. Craig Millian, MBA Chief Operating Officer Experience leading commercial organizations and building successful brands at multiple biopharma companies Rachael Brake, PhD Chief Scientific Officer Expert in developing and executing innovative drug discovery and clinical development oncology programs at several leading pharmaceutical companies Christina Bertsch Head of Human Resources Accomplished senior human resource executive providing strategic HR consulting services to both large and small businesses across a variety of industries


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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 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; 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 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).


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Investment Summary Advancing anti-⍺vβ8 integrin program to IND submission in H2 2023 Engaging in business development activities to expand Corbus oncology pipeline Sufficient capital to fund operations through the second quarter of 2024 CRBP Ticker $59.2 Million Cash and investments as of  December 31, 2022  4.17M Common Shares Outstanding1 (4.87M Fully Diluted) 1 Focus on developing precision oncology + differentiated assets Clinically developing the next generation Nectin-4 targeting ADC 1. Reflects 1 for 30 reverse stock split effective Feb 14, 2023


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