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Equillium Reports Third Quarter 2018 Financial Results and Recent Highlights

Completes Successful Initial Public Offering Raising Gross Proceeds of Approximately $71.6 Million

On-Track for Early 2019 Initiation of Phase 1b/2 Trial of EQ001 in Acute Graft-Versus-Host Disease

LA JOLLA, Calif., Nov. 15, 2018 (GLOBE NEWSWIRE) -- Equillium, Inc. (EQ), a biotechnology company developing treatments for severe immuno-inflammatory disorders, today announced financial results for the third quarter ended September 30, 2018, and recent business highlights.

Business Highlights:

  • Completed a successful initial public offering of common stock on the Nasdaq Global Market that raised gross proceeds of approximately $71.6 million through the issuance of 5,115,097 shares at a public offering price of $14.00 per share, including shares that the underwriters elected to purchase pursuant to their over-allotment option
  • Received “Study May Proceed Letter” from the U.S. Food and Drug Administration (FDA) for the Company’s Investigational New Drug (IND) application to commence a Phase 1b/2 clinical trial of EQ001 for the treatment of acute graft-versus-host disease (aGVHD)
  • Expanded leadership team with appointment of Dr. Krishna Polu as Chief Medical Officer
  • Strengthened Board of Directors with the appointment of three independent directors: Martha Demski, Charles McDermott and Mark Pruzanski, M.D.

“It is remarkable what can be accomplished in a short period of time when surrounded by a team of accomplished, capable, and dedicated individuals,” said Daniel Bradbury, Chairman and Chief Executive Officer of Equillium. “In less than two years we went from the seed of an idea for a business, to in-licensing our first product candidate, EQ001, opening an IND with the FDA and then successfully completing the initial public offering of our common stock. Today, we believe we have the focus and financial resources to execute on the clinical development of our pipeline to treat immuno-inflammatory disorders, starting first with aGVHD in early 2019, followed rapidly by severe refractory asthma, with additional studies in other important indications planned to commence shortly thereafter. Our hope is to improve the lives of patients who face severe immuno-inflammatory conditions, have limited treatment options and don’t respond to existing therapies.”

Upcoming Milestones:

  • Initiate a Phase 1b/2 trial of EQ001 in aGVHD (early 2019)
  • Initiate a proof-of-concept clinical trial of EQ001 for the treatment of severe asthma (1H 2019)
  • Initiate a Phase 2 trial of EQ001 in chronic GVHD (1H 2019)
  • Select a fourth indication for future EQ001 clinical development (1H 2019)

Third Quarter 2018 Financial Results

Research and development (R&D) expenses. Total R&D expenses for the three months ended September 30, 2018 were $1.2 million, compared with approximately $50 thousand for the same period in 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, and preclinical research activities to support the Company’s clinical development program.

General and administrative (G&A) expenses. Total G&A expenses for the three months ended September 30, 2018 were $1.0 million, compared with approximately $34 thousand for the same period in 2017. The increase in G&A expenses was primarily driven by additional costs related to increased headcount and costs incurred during the third quarter of 2018 associated with supporting the increased level of clinical and finance activities and preparing to become a public company. 

Net loss. Total net loss for the three months ended September 30, 2018 was $4.9 million, compared with approximately $141 thousand for the same period in 2017.

Cash and cash equivalents. As of September 30, 2018, Equillium reported total cash and cash equivalents of approximately $5.0 million, compared to $7.1 million at December 31, 2017. Subsequent to the end of the third quarter, the Company completed a successful initial public offering of its common stock, raising gross proceeds of approximately $71.6 million.  

About Equillium

Equillium is a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium’s initial product candidate, EQ001 (itolizumab), is a clinical-stage, first-in-class monocolonal antibody that selectively targets the novel immune checkpoint receptor CD6 to modulate T cells that drive immuno-inflammation. Itolizumab is a clinically-validated therapeutic with a favorable safety and tolerability profile. Equillium plans to advance EQ001 into clinical development in multiple immuno-inflammatory indications of high unmet medical need and believes EQ001 has the potential to be a best-in-class disease modifying therapeutic. For more information, visit www.equilliumbio.com.

Forward Looking Statements

This press release contains forward-looking statements regarding Equillium’s current expectations within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements include, without limitation  the timing of Equillium’s clinical development milestones for EQ001 and the sufficiency of Equillium’s focus and financial resources to achieve such clinical development milestones. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the dependence on the success of clinical trial(s) of EQ001, the lengthy and uncertain regulatory approval process, uncertainties related to the initiation and completion of clinical trials, including the initiation of Phase 1b/2 trial of EQ001 in aGVHD in early 2019 and whether the final results from EQ001 trials and studies will validate and support the safety and efficacy of EQ001. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that Equillium will be able to develop commercially viable product candidates. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in Equillium’s operations and business environments. These risks and uncertainties are described more fully in Equillium’s Registration Statement on Form S-1, as amended, as filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Equillium undertakes no duty to update such information except as required under applicable law.

EQUILLIUM, INC.
BALANCE SHEETS
         
    September 30,   December 31,
    2018   2017
    (unaudited)    
Assets        
Current assets:        
Cash and cash equivalents   $   4,982,505     $   7,103,553  
Prepaid expenses and other current assets       77,805         45,813  
Total current assets       5,060,310         7,149,366  
Property and equipment, net       31,887         2,077  
Deferred offering costs       1,329,350         -   
Total assets   $   6,421,547     $   7,151,443  
Liabilities and stockholders' deficit        
Current liabilities:        
Accounts payable   $   1,230,262     $   243,741  
Accrued expenses       1,449,492         325,079  
Total current liabilities       2,679,754         568,820  
Long-term convertible promissory notes       10,321,940         6,994,847  
Long-term convertible promissory notes, related party       1,274,784         1,064,019  
Biocon anti-dilution right       2,375,109         775,842  
Other non-current liabilities       148,724         -   
Total liabilities       16,800,311         9,403,528  
Commitments and contingencies        
Stockholders' deficit:        
Common stock, $0.0001 par value; 43,100,000 shares authorized at December 31, 2017 and September 30, 2018 (unaudited); 10,708,074 and 11,130,446 shares issued and outstanding as of December 31, 2017 and September 30, 2018 (unaudited), respectively       166         124  
Additional paid-in capital       141,526         9,665  
Accumulated deficit       (10,520,456 )       (2,261,874 )
Total stockholders' deficit       (10,378,764 )       (2,252,085 )
Total liabilities and stockholders' deficit   $   6,421,547     $   7,151,443  
                 


EQUILLIUM, INC.
STATEMENT OF OPERATIONS
                 
    Three Months Ended
September 30,
  Nine Months Ended
September 30,
  Period March 16,
2017 (Inception)
Through
September 30,
    2018   2017   2018   2017
    (unaudited)
Operating expenses:                
Research and development   $   1,222,296     $   49,949     $   2,425,213     $   851,313  
General and administrative       1,003,584         33,762         1,962,276         220,935  
Total operating expenses       2,225,880         83,711         4,387,489         1,072,248  
Loss from operations       (2,225,880 )        (83,711 )       (4,387,489 )       (1,072,248 )
Other expense (income):                
Interest expense       1,221,100         15,123         2,329,296         22,192  
Interest income       (27,544 )       -          (57,470 )       -   
Change in fair value of Biocon anti-dilution right       1,496,987         42,191         1,599,267         61,078  
Total other expense (income)       2,690,543         57,314         3,871,093         83,270  
Net loss and comprehensive loss   $   (4,916,423 )   $   (141,025 )   $   (8,258,582 )   $   (1,155,518 )
Net loss per share, basic and diluted   $   (0.44 )   $   (0.01 )   $   (0.76 )   $   (0.16 )
Weighted-average common shares outstanding, basic and diluted       11,078,840         10,708,074         10,835,483         7,127,537  
                                 

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