EX-99.1

Exhibit 99.1

Corbus Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Latest pre-clinical data for CRB-601 monotherapy and in combination with anti-PD1 therapy to be presented this Thursday at SITC 2022
IND submission for CRB-601 is on track for mid-2023
Expanding oncology pipeline through strategic transactions remains key priority
Cash and investments on hand of $67 million funds operations through the second quarter of 2024

 

Norwood, MA, November 8, 2022 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology company, today provided a corporate update and reported financial results for the third quarter of 2022.

 

Key Corporate and Program Updates:

Anti-integrin monoclonal antibody (mAb) programs targeting the inhibition of TGFβ are progressing on schedule
o
CRB-601, an anti-αvβ8 mAb, is being developed as a potential treatment for solid tumors.
o
Across models explored to-date, CRB-601 demonstrates an enhancement of anti-tumor activity when combined with anti PD-1 therapy compared to either single agent alone. Latest data to be presented this Thursday at SITC 2022.
o
Data supports the hypothesis that blockade of latent TGFb production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, potentially enhancing the benefit of PD-1 blockade.
o
IND-enabling activities for CRB-601 are ongoing and the program is on schedule for an IND submission in mid-2023.
o
Recent clinical updates from investigational therapies also targeting latent TGFb reinforce the promise of this novel approach in oncology.

 

CB1 inverse agonist program for obesity / metabolism
o
CRB-913, a novel CB1 inverse agonist with highly differentiated PK from other members of its class, has demonstrated weight loss and improvement in multiple metabolic parameters, as monotherapy and in combination within liraglutide, semaglutide and tirzepatide in animal models of diet-induced obesity.
o
New data was shared in an oral presentation at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2022. View the presentation here.
o
Data is being prepared for publication.
o
Corbus is actively exploring partnerships to advance CRB-913 into clinical studies.

 

A detailed update on the Corbus pipeline can be found in the most recent Corporate Presentation available on the Company’s website here.

 

 


 

“We continue to progress CRB-601 toward the clinic on schedule and on budget. Our latest pre-clinical data, to be presented this Thursday at SITC 2022, further reinforces our belief that this could be a highly impactful drug in oncology therapy, and we look forward to the latest clinical updates from this field,” commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “We continue to be actively engaged in business development activities with the goal of expanding our pipeline while also bringing in non-dilutive funding by monetizing our portfolio of endocannabinoid assets through new partnerships.”

 

Financial Results for Third Quarter Ended September 30, 2022:

The Company reported a net loss of approximately $8.8 million, or a net loss per diluted share of $0.07, for the three months ended September 30, 2022, compared to a net loss of approximately $2.2 million, or a net loss per diluted share of $0.02, for the same period in 2021. The prior year third quarter included a $12.3 million refundable tax credit received from a foreign tax authority.


Operating expenses for Q3 2022 decreased by $5.8 million to approximately $8.2 million for the three months ended September 30, 2022, compared to $14.0 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.


In October of 2022, the Company amended its debt agreement with K2 HealthVentures LLC to defer commencement of principal payments by one year until September 2023 which improved the Company’s liquidity and cash runway. As of September 30, 2022, the Company has $67 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 is an oncology company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ current pipeline includes anti-integrin monoclonal antibodies that block activation of TGFβ and small molecules that activate or inhibit the endocannabinoid system. 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

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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 CONTACTS:

Sean Moran

Chief Financial Officer

smoran@corbuspharma.com

 

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

 

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Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Balance Sheets

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

12,443,645

 

 

$

25,006,632

 

Investments

 

 

53,785,559

 

 

 

72,640,520

 

Restricted cash

 

 

192,475

 

 

 

192,475

 

Prepaid expenses and other current assets

 

 

926,161

 

 

 

2,365,010

 

Total current assets

 

 

67,347,840

 

 

 

100,204,637

 

Restricted cash

 

 

477,425

 

 

 

477,425

 

Property and equipment, net

 

 

1,798,212

 

 

 

2,392,696

 

Operating lease right of use assets

 

 

4,074,074

 

 

 

4,609,110

 

Other assets

 

 

133,055

 

 

 

46,385

 

Total assets

 

$

73,830,606

 

 

$

107,730,253

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Notes payable

 

$

 

 

$

767,938

 

Accounts payable

 

 

1,374,220

 

 

 

1,782,277

 

Accrued expenses

 

 

4,833,839

 

 

 

10,093,312

 

Derivative liability

 

 

133,710

 

 

 

133,710

 

Operating lease liabilities, current

 

 

1,243,802

 

 

 

1,136,948

 

Current portion of long-term debt

 

 

9,883,638

 

 

 

3,093,344

 

Total current liabilities

 

 

17,469,209

 

 

 

17,007,529

 

Long-term debt, net of debt discount

 

 

9,385,847

 

 

 

15,636,275

 

Other long-term liabilities

 

 

22,205

 

 

 

22,205

 

Operating lease liabilities, noncurrent

 

 

5,007,236

 

 

 

5,956,217

 

Total liabilities

 

 

31,884,497

 

 

 

38,622,226

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares authorized,
   125,280,881 and 125,230,881 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

12,528

 

 

 

12,523

 

Additional paid-in capital

 

 

423,342,069

 

 

 

418,891,713

 

Accumulated deficit

 

 

(381,201,614

)

 

 

(349,733,764

)

Accumulated other comprehensive loss

 

 

(206,874

)

 

 

(62,445

)

Total stockholders’ equity

 

 

41,946,109

 

 

 

69,108,027

 

Total liabilities and stockholders’ equity

 

$

73,830,606

 

 

$

107,730,253

 

 

 

 

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Corbus Pharmaceuticals Holdings, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

 

 

For the Three Months
Ended September 30,

 

 

For the Nine Months
Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue from awards

 

$

 

 

$

97,323

 

 

$

 

 

$

881,705

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,108,190

 

 

 

8,695,641

 

 

 

9,894,068

 

 

 

30,681,684

 

General and administrative

 

 

4,073,266

 

 

 

5,277,090

 

 

 

14,144,557

 

 

 

16,190,684

 

Litigation Settlement

 

 

 

 

 

 

 

 

5,000,000

 

 

 

 

Total operating expenses

 

 

8,181,456

 

 

 

13,972,731

 

 

 

29,038,625

 

 

 

46,872,368

 

Operating loss

 

 

(8,181,456

)

 

 

(13,875,408

)

 

 

(29,038,625

)

 

 

(45,990,663

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

77,712

 

 

 

12,033,031

 

 

 

(324,322

)

 

 

11,790,328

 

Interest income (expense), net

 

 

(541,889

)

 

 

(391,867

)

 

 

(1,491,137

)

 

 

(1,439,587

)

Change in fair value of derivative liability

 

 

 

 

 

472,143

 

 

 

 

 

 

670,143

 

Foreign currency exchange gain (loss), net

 

 

(136,087

)

 

 

(414,048

)

 

 

(613,766

)

 

 

(409,914

)

Other income (expense), net

 

 

(600,264

)

 

 

11,699,259

 

 

 

(2,429,225

)

 

 

10,610,970

 

Net loss

 

$

(8,781,720

)

 

$

(2,176,149

)

 

$

(31,467,850

)

 

$

(35,379,693

)

Net loss per share, basic and diluted

 

$

(0.07

)

 

$

(0.02

)

 

$

(0.25

)

 

$

(0.29

)

Weighted average number of common shares outstanding, basic and diluted

 

 

125,268,381

 

 

 

125,209,985

 

 

 

125,255,927

 

 

 

122,234,847

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,781,720

)

 

$

(2,176,149

)

 

$

(31,467,850

)

 

$

(35,379,693

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized gain (loss) on marketable debt securities

 

 

(87,554

)

 

 

(3,513

)

 

 

(144,429

)

 

 

(8,967

)

Total other comprehensive income (loss)

 

 

(87,554

)

 

 

(3,513

)

 

 

(144,429

)

 

 

(8,967

)

Total comprehensive loss

 

$

(8,869,274

)

 

$

(2,179,662

)

 

$

(31,612,279

)

 

$

(35,388,660

)

 

 

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