OREANDA-NEWS. Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial and operational results for its fiscal first quarter of 2016, ended March 31, 2016.

“Our focus at Interleukin Genetics over the past year has been on developing a commercial plan that will drive market adoption of PerioPredict®, our genetic test that identifies individuals with an increased risk for severe and progressive periodontitis due to a life-long genetic predisposition to over-produce Interleukin-1 (IL-1), a key mediator of inflammation. Elevated inflammation is implicated in numerous chronic diseases,” said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics. 

“Our enhanced positioning of PerioPredict underscores the medical value of managing inflammation through practical dental interventions,” Mr. Carbeau continued.  “Multiple studies document the role of systemic inflammation in driving serious chronic diseases such as diabetes, cardiovascular disease and periodontitis.  Studies also document that preventive dental care and treatment of periodontitis can lower systemic inflammatory burden, and substantial medical cost savings for patients with certain chronic diseases were observed after these dental treatments were provided.  We believe our integrated approach can transform management of inflammatory diseases, using genetic insights and digital health tools to target high risk individuals, to educate care givers and to engage patients.  This value proposition is being well received by our primary customers—self-insured employers and insurance carriers.”

“We are also seeing evidence of the value of our expertise in IL-1 genetics in other applications, such as our collaborations with pharmaceutical and biotech companies to support the clinical development of novel therapeutics,” continued Mr. Carbeau. “We believe our technology made a significant contribution in our recent collaboration with ElevenBio Therapeutics. Further, in our collaboration with Ionis Pharmaceuticals, their program is moving into Phase 2 clinical trials.  We believe that there may be similar opportunities for Interleukin in the future with other companies developing IL-1 blocking drugs. We also continue to explore other genetic testing applications, such as in cardiovascular disease, where the utility of our test panels may help physicians better manage patients and drive improved outcomes.”

2016 Highlights to Date

  • Signed Agreement to Incorporate PerioPredict into Metagenics’ Employee Benefit Plan:  Interleukin will provide the PerioPredict test to Metagenics’ employees as part of an enhanced employee benefits program.  PerioPredict will be used to identify individuals who may benefit from reduction of their systemic inflammatory burden as an approach to enhance prevention and management of chronic diseases.
     
  • Signed Agreement to Incorporate PerioPredict into Freedom Dental Plan:  Reimbursement Specialists, Inc., a Comprehensive Benefit Administrators (CBA) company and leading provider of benefits management services, will include coverage for PerioPredict as part of CBA’s Freedom Dental Plan. PerioPredict testing will guide additional preventative care for patients identified as having an increased risk for developing severe periodontal disease.
     
  • Collaborated with Eleven Biotherapeutics to Provide Genetic Stratification of Drug Response in IL-1 Implicated Eye Diseases: Evaluated subjects in Eleven Bio’s Phase 3 study for allergic conjunctivitis and dry eye, utilizing our IL-1 genetic patterns to help assess clinical response to isunakinra (EBI-005), their novel interleukin-1 receptor inhibitor.  Our data provided post hoc evaluation of patient IL-1 genotypes and showed a differential clinical response within the studies providing the opportunity for further evaluation of the drug and genetic link.
     
  • Collaborated with Ionis Pharmaceuticals to Provide Genotyping of Clinical Trial Subjects for Their Cardiovascular Drug Candidate:  The 681257-CS1 project with Ionis has been completed and all Interleukin deliverables were met. The IONIS-APO(a)-LRX drug candidate has completed Phase 1 and is moving into Phase 2 Clinical trials.
     
  • Appointed Global Clinical Advisory Board to Guide Enhanced Healthcare Through Targeted Management of Systemic Inflammation: Interleukin formed a Clinical Advisory Board of leading experts to advise the Company on clinical programs aimed at demonstrating the clinical and health economic benefits of targeted prevention and treatment of periodontitis, a common local inflammatory disease, in the management of several chronic diseases that affect widespread tissues and organs of the body.
     
  • Initiated a Clinical Study to Evaluate Impact of PerioPredict on Dental Patient Engagement and Preventative Care: Received Institutional Review Board (IRB) approval for a clinical study to assess the impact of PerioPredict on dental patient engagement for more preventive dental care. The study will build on Interleukin Genetics’ evidence base in support of the medical and economic value of the PerioPredict genetic testing platform.
     
  • Reached Alignment with the U.S. Food and Drug Administration (FDA) on compliance status of Interleukin’s genetic tests: Discussions with the FDA confirmed that PerioPredict is a laboratory developed test currently subject to FDA enforcement discretion and may continue to be marketed without prior marketing authorization.  The Company’s Bone Health and Heart Health tests, which are part of the Inherent Health® line of tests, will be transitioned from a direct-to-consumer (DTC) distribution channel to a distribution model under which a licensed healthcare provider orders tests and oversees any resulting change in care. We are continuing discussions with the FDA to determine appropriate next steps, if any, for our Weight Management test, which is marketed both through professional channels and DTC.
     
  • Received Notice of Allowance for United States Patent for PerioPredict:  Received a notice of allowance for a patent by the United States Patent and Trademark Office (USPTO) for an application, entitled “Method for Determining Severity and Progression of Periodontal Disease”. It has claims covering methods of determining a subject’s genotype to ascertain their risk of developing severe periodontal disease and the treatment of those at risk to slow the progression of the disease.


First Quarter 2016 Financial Results
Total revenues for the first quarter ended March 31, 2016, were $961,000 compared to $403,000 for the same period in 2015. The change in total revenue is largely attributable to revenue from a contracted research program, partially offset by a decrease in the Company’s genetic test kits returned for processing related to the Company’s sales through Access Business Group’s promotional product bundle program.

Research and development (R&D) expenses for the first quarter ended March 31, 2016, were $480,000 compared to $183,000 for the same period in 2015. The increase is primarily attributable to expenses related to Dr. Kornman moving to the R&D department in April 2015 as President and Chief Scientific Officer from his previous position as CEO. Previously expenses generated by Dr. Kornman were recorded as selling, general and administrative expenses.

Selling, general and administrative expenses were $1.3 million for the three months ended March 31, 2016, compared to $1.6 million for the three months ended March 31, 2015.  The 16% decrease is primarily attributable to lower compensation costs, CEO recruiting expenses in 2015 and Dr. Kornman’s expenses being recorded in research and development, partially offset by increased expenses related to the new CEO in 2016. 

Net loss for the first quarter ended March 31, 2016, was $1.5 million or $(0.01) per basic and diluted common share compared to $1.8 million or $(0.01) per basic and diluted common share for the same period in 2015.

Cash and cash equivalents at March 31, 2016, were $2.9 million, which management believes is sufficient to fund the Company’s operations into the second half of 2016.

About PerioPredict 
PerioPredict is an innovative, easy-to-use genetic test that identifies individuals with an increased risk for severe and progressive periodontitis, due to a life-long genetic predisposition to over-produce Interleukin-1 (IL-1), a key mediator of inflammation. Such individuals may benefit from enhanced dental care to prevent or treat periodontitis and thereby lower their systemic inflammatory burden. Targeted management of systemic inflammation has been shown to help manage several chronic diseases, including type 2 diabetes and coronary artery disease. The PerioPredict test is made available to employees in covered health plans under the supervision of a licensed dentist or physician, and the results provide important information to dental professionals for assessing prevention and treatment options for their patients. The PerioPredict test is run solely in Interleukin’s CLIA-certified lab in Waltham, MA. 

About Interleukin Genetics
Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic diseases and health-related conditions. The products empower individuals to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with actionable guidance. Interleukin Genetics leverages its research, intellectual property and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The Company markets its tests through healthcare professionals, partnerships with health and wellness companies, and other distribution channels. Interleukin Genetics’ lead products include its proprietary PerioPredict Genetic Risk Test for periodontal disease and tooth loss susceptibility available through dentists, and the Inherent Health Weight Management Genetic Test that identifies the most effective diet program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, MA, and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA).

INTERLEUKIN GENETICS, INC.
FINANCIAL HIGHLIGHTS
             
Balance Sheet Data March 31,   March 31,  
        2016       2015    
             
Cash and cash equivalents $  2,892,182     $  4,706,018    
Total current assets $  3,938,417     $  5,695,533    
Total assets   $  4,615,815     $  6,491,520    
             
Total current liabilities $  5,441,277     $  5,477,936    
Total liabilities   $  8,374,408     $  8,952,920    
             
Total shareholders' equity/(deficit) $  (3,758,593 )   $  (2,461,400 )  
             
Total liabilities and shareholders' deficit $  4,615,815     $  6,491,520    
             
             
Statement of Operations Data Three Months Ended Mar 31,  
        2016       2015    
Revenue:          
  Genetic testing service revenue $  262,469     $  347,900    
  Other      698,449        55,312    
Total revenue      960,918        403,212    
    Less Sales Allowance & Discount    -         -     
Net revenue      960,918        403,212    
Cost of Revenue    526,946        331,041    
             
Gross profit (loss)    433,972        72,171    
             
Operating costs and expenses:        
  Research and development    480,057        182,530    
  Selling, general and administrative    1,311,185        1,562,791    
  Amortization of intangibles    8,362        19,414    
             
Total operating expenses    1,799,604        1,764,735    
             
Loss from operations    (1,365,632 )      (1,692,564 )  
             
Total other income and (expense), net    (152,104 )      (150,631 )  
Loss from continuing operations        
  before income taxes    (1,517,736 )      (1,843,195 )  
Income taxes      -         -     
Loss from continuing operations $  (1,517,736 )   $  (1,843,195 )  
Income from discontinued Operations,        
  net of  income taxes    -         -     
Net loss   $  (1,517,736 )   $  (1,843,195 )  
             
Basic and diluted net (loss) income per        
  common share from:        
Continuing operations $  (0.01 )   $  (0.01 )  
Discontinued operations   0.00       0.00    
Net loss   $  (0.01 )   $  (0.01 )  
Weighted average common shares outstanding,        
  basic and diluted   172,951,968       172,737,553