WALTHAM, Mass., Nov. 12, 2015 (GLOBE NEWSWIRE) -- Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial and operational results for its fiscal third quarter of 2015, ended September 30, 2015.
"Since joining Interleukin Genetics in April, I have been focused on developing a strategic and operational plan that will lay the groundwork for driving market adoption of PerioPredict®, our genetic test that identifies individuals with a life-long predisposition to over-produce inflammation. Elevated inflammation is implicated in numerous chronic diseases." said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics.
"We are encouraged by the reception of our enhanced positioning that outlines medical value for managing inflammation through practical dental interventions", Mr. Carbeau continued. "Medical studies now 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 lower systemic inflammatory burden, and that these dental treatments provide substantial medical cost savings for patients with certain chronic diseases. PerioPredict helps identify and engage high risk patients who will benefit from these interventions. Our demand generation efforts are being focused initially on large employers and insurance carriers; we continue to make progress on both fronts."
"We are also utilizing our expertise in interleukin-1 genetics to develop high-value, next-generation genetic tests that leverage our intellectual property and the growing interest in IL-1 biology," continued Mr. Carbeau. "We are exploring the utility of our test panels to help physicians better manage cardiovascular disease patients, and are in discussions with pharmaceutical and biotech companies to provide clinical testing and to develop companion diagnostics for drug candidates in this area."
2015 Year to Date Highlights
PerioPredict®
- Implemented Strategic Plan to Enhance Commercial Positioning and Drive Sales for PerioPredict: New plan positions PerioPredict as the cornerstone of a disease prevention program that targets individuals with chronic conditions such as type 2 diabetes and cardiovascular disease who will benefit from increased dental preventive care that can substantially lower systemic inflammation.
- Signed Collaborative Agreement with Employee Benefit Consulting Group: Interleukin and EBCG are working together to build awareness of PerioPredict as a powerful tool for personalizing patient care among insurance carriers, benefit plans and employer groups, and to potentially incorporate the test in the design of risk-based benefit plans.
- Demonstration Programs: The Company is expanding its activities with medical and dental carriers to initiate demonstration programs that could lead to broader program adoption.
Other Events
- Signed Agreements with Isis Pharmaceuticals: Interleukin and Isis Pharmaceuticals entered into two agreements under which Interleukin will provide genetic testing services and kits to support two Isis clinical programs in cardiovascular disease.
- License Agreement Signed with NYU School of Medicine: The agreement covers the development and commercialization of the first genetic test of its kind to identify individuals at increased risk for progression of osteoarthritis (OA) and related complications. The OA genetic test is being designed to provide physicians and pharmaceutical and medical device companies with novel genetic information to identify high-risk patients and develop personalized treatment options.
- Received Notice of Allowance On a European Patent Application: The patent application, No. 09740020.4, relates to a method and kits for detecting a predisposition to, determining risk of, and guiding therapy for incident osteoarthritis, osteoarthritis progression, osteoarthritis severity, associated physical function decline and disability.
- Two Late-Breaking Posters Presented at 2015 Experimental Biology Annual Meeting: At the Experimental Biology Annual Meeting in March, data from two important studies were presented by Interleukin's collaborators highlighting the influence of genetics on both body composition and weight loss in response to particular diet and exercise programs.
- Poster Presentations at International Society of Sports Nutrition Annual Conference: Interleukin's collaborators at Texas A&M University presented two posters discussing the effects of matching diet type to obesity-related genotype on body composition changes in women and the influence of matching diet type to obesity-related genotype on changes in visceral adipose tissue in women during a six-month resistance-exercise training and walking program.
- Key European Patent Granted: The European patent, titled "Genetic Markers for Weight Management and Methods of Use Thereof", has claims covering methods of determining a subject's metabolic genotype and methods for selecting an appropriate therapeutic/dietary regimen or lifestyle recommendation based on the subject's metabolic profile and susceptibility to adverse weight management issues. Corresponding patents have been granted in other major markets and patent applications are pending in the U.S and several other markets.
- Received a Grant Notice Regarding a Chinese Patent Application: The Chinese Patent Application, No. 200980127719.9, titled "Genetic Markers for Weight Management and Methods of Use Thereof", relates to metabolic genotype body metabolism genes critical to establishing a patient's personal weight loss plan.
Corporate
- Mark B. Carbeau appointed Chief Executive Officer: Mr. Carbeau has a proven track record of building high growth diagnostic and pharmaceutical businesses, bringing more than three decades of business expertise in the life sciences industry. Dr. Kenneth Kornman, who was President and CEO from 2012 to 2015, continues to serve as President, Chief Scientific Officer and Director.
Third Quarter 2015 Financial Results
Total revenues for the third quarter ended September 30, 2015, were $296,000 compared to $472,000 for the same period in 2014. The change in total revenue is largely attributable to 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 third quarter ended September 30, 2015, were $412,000 compared to $242,000 for the same period in 2014. The increase is primarily attributable to increased compensation due to annual salary increases for existing staff, and other expenses relating to Dr. Kornman moving to the R&D department from the Selling, General and Administrative (SG&A) area in April 2015.
SG&A expenses for the third quarter ended September 30, 2015, were $1.4 million compared to $1.3 million for the same period in 2014. The increase is primarily attributable to compensation and other employee expenses as well as higher consulting costs.
Net loss for the third quarter ended September 30, 2015, was $2.0 million or $(0.01) per basic and diluted common share compared to $1.5 million or $(0.01) per basic and diluted common share for the same period in 2014.
Cash and cash equivalents at September 30, 2015, were $6.3 million, which management believes is sufficient to fund the Company's operations into the second half of 2016.
About PerioPredict®
The PerioPredict® genetic test is quick, easy and painless and is performed under the direction of a dental or medical professional. PerioPredict® measures variations in genes for Interleukin-1 (IL-1) to identify individuals with a life-long predisposition to overproduce inflammation who will benefit from increased dental care to prevent or treat periodontitis to lower systemic inflammatory burden. PerioPredict® is run solely in the Interleukin Genetics CLIA-certified lab in Waltham, Mass. For more information, please visit www.PerioPredict.com.
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 panel 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). For more information, please visit www.ilgenetics.com.
Forward-Looking Statements
Certain statements contained herein are "forward-looking" statements, including statements that there is potential value in expanding the application of the Company's expertise in interleukin-1 genetics to collaborate with pharmaceutical firms to support the development of drug candidates that block interleukin-1, that the Company's expanded activities with medical and dental carriers to initiate demonstration programs could lead to broader program adoption, that the Company's genetic tests may provide physicians and pharmaceutical and medical device companies with novel genetic information to identify high-risk patients and develop personalized treatment options, and that cash and cash equivalents as of September 30, 2015, are sufficient to fund the Company's operations into the second half of 2016. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company's annual report on Form 10-K for the year ended December 31, 2014, and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.
| INTERLEUKIN GENETICS, INC. | ||||
| FINANCIAL HIGHLIGHTS | ||||
| Balance Sheet Data | September 30, | December 31, | ||
| 2015 | 2014 | |||
| Cash and cash equivalents | $ 6,270,644 | $ 11,466,807 | ||
| Total current assets | $ 7,007,273 | $ 12,180,658 | ||
| Total assets | $ 7,902,830 | $ 13,267,121 | ||
| Total current liabilities | $ 3,957,234 | $ 4,011,650 | ||
| Total liabilities | $ 8,748,125 | $ 8,750,264 | ||
| Total shareholders' equity/(deficit) | $ (845,295) | $ 4,516,857 | ||
| Total liabilities and shareholders' deficit | $ 7,902,830 | $ 13,267,121 | ||
| Statement of Operations Data | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | ||
| 2015 | 2014 | 2015 | 2014 | |
| Revenue: | ||||
| Genetic testing service revenue | $ 248,873 | $ 439,400 | $ 921,610 | $ 1,342,947 |
| Other | 47,125 | 32,751 | 153,651 | 145,365 |
| Total revenue | 295,998 | 472,151 | 1,075,261 | 1,488,312 |
| Net revenue | 295,998 | 472,151 | 1,075,261 | 1,488,312 |
| Cost of Revenue | 323,136 | 358,578 | 985,732 | 1,115,095 |
| Gross profit (loss) | (27,138) | 113,573 | 89,529 | 373,217 |
| Operating costs and expenses: | ||||
| Research and development | 411,902 | 242,142 | 978,970 | 666,839 |
| Selling, general and administrative | 1,413,702 | 1,305,583 | 4,631,718 | 4,338,245 |
| Amortization of intangibles | 19,414 | 23,525 | 58,242 | 70,575 |
| Total operating expenses | 1,845,018 | 1,571,250 | 5,668,930 | 5,075,659 |
| Loss from operations | (1,872,156) | (1,457,677) | (5,579,401) | (4,702,442) |
| Total other income and (expense), net | (153,354) | 911 | (456,089) | 4,511 |
| Loss from continuing operations before income taxes | (2,025,510) | (1,456,766) | (6,035,490) | (4,697,931) |
| Income taxes | -- | -- | -- | -- |
| Loss from continuing operations | $ (2,025,510) | $ (1,456,766) | $ (6,035,490) | $ (4,697,931) |
| Income from discontinued Operations, net of income taxes | -- | -- | -- | -- |
| Net loss | $ (2,025,510) | $ (1,456,766) | $ (6,035,490) | $ (4,697,931) |
| Basic and diluted net (loss) income per common share from: | ||||
| Continuing operations | $ (0.01) | $ (0.01) | ($0.03) | ($0.04) |
| Discontinued operations | 0.00 | 0.00 | 0.00 | 0.00 |
| Net loss | $ (0.01) | $ (0.01) | ($0.03) | ($0.04) |
| Weighted average common shares outstanding, basic and diluted | 172,841,047 | 122,548,292 | 172,788,286 | 122,515,671 |