UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K

 

[X] ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended: DECEMBER 31, 2016

 

[  ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ______________ to ______________

 

Commission File Number: 0-13092

 

SPECTRASCIENCE, INC.

(Exact name of registrant as specified in its charter)

 

MINNESOTA   41-1448837
(State of incorporation)  

(I.R.S. Employer Identification No.)

 

11568-11 Sorrento Valley Road, San Diego, CA   92121
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number: (858) 847-0200

 

Securities registered under Section 12(b) of the Exchange Act: NONE

 

Securities registered under Section 12(g) of the Exchange Act:

COMMON STOCK, $0.01 PAR VALUE

(Title of Class)

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

 

Yes [  ] No [X]

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act.

 

Yes [  ] No [X]

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

Yes [X] No [  ]

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer [  ] Accelerated filer [  ] Non-accelerated filer [  ] Smaller reporting company [X]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes [  ] No [X]

 

The aggregate market value of the voting Common Stock held by non-affiliates, computed by reference to the price at which the voting Common Stock was sold as of the last business day of the Company’s most recently completed second fiscal quarter is $5,632,000.

 

As of March 31, 2017, the number of outstanding shares of the registrant’s Common Stock, par value $0.01 per share, were 1,413,320,059.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

None.

 

 

 

 
 

 

SPECTRASCIENCE, INC.

 

FORM 10-K

For the Fiscal Year Ended December 31, 2016

TABLE OF CONTENTS

 

    Page
PART I   3
Item 1. Business   3
Item 1A. Risk Factors   14
Item 1B. Unresolved Staff Comments   20
Item 2. Properties   20
Item 3. Legal Proceedings   20
Item 4. Mine Safety Disclosures   20
PART II   21
Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities   21
Item 6. Selected Financial Data   22
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations   22
Item 7A. Quantitative and Qualitative Disclosures About Market Risk   28
Item 8. Financial Statements and Supplementary Data   28
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure   54
Item 9A. Controls and Procedures   54
Item 9B. Other Information   55
PART III   55
Item 10. Directors, Executive Officers and Corporate Governance   55
Item 11. Executive Compensation   58
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters   60
Item 13. Certain Relationships and Related Transactions, and Director Independence   62
Item 14. Principal Accounting Fees and Services   63
PART IV   64
Item 15. Exhibits and Financial Statement Schedules   64
SIGNATURES   65

 

2  
 

 

DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

 

Certain statements contained in this Annual Report on Form 10-K constitute “forward-looking statements”. These statements, identified by words such as “plan”, “anticipate”, “believe”, “estimate”, “should,” “expect” and similar expressions include our expectations and objectives regarding our future financial position, operating results and business strategy. These statements reflect the current views of management with respect to future events and are subject to risks, uncertainties and other factors that may cause our actual results, performance or achievements, or industry results, to be materially different from those described in the forward-looking statements. Such risks and uncertainties include those set forth under the caption “Risk Factors” and elsewhere in this Form 10-K. We advise you to carefully review the reports and documents we file from time to time with the Securities and Exchange Commission (“SEC”), particularly our quarterly reports on Form 10-Q and our current reports on Form 8-K.

 

As used in this annual report, the terms “we”, “us”, “our”, and “SpectraScience” mean SpectraScience, Inc., unless otherwise indicated.

PART I

 

ITEM 1. BUSINESS.

 

Introduction

 

SpectraScience was incorporated in the State of Minnesota on May 4, 1983 as GV Medical, Inc. In October 1992, GV Medical changed its name to SpectraScience, Inc. The Company focuses on developing its WavSTAT ® Optical Biopsy System (“WavSTAT”). The WavSTAT employs a non-significant risk technology that optically illuminates tissue in real-time to distinguish between normal and pre-cancerous or cancerous tissue.

 

Our principal executive offices are located at 11568 Sorrento Valley Rd., Suite 11, San Diego, CA 92121. You can reach us by telephone at (858) 847-0200; by fax at (858) 847-0880; or by email at info@spectrascience.com. Our website address is www.spectrascience.com . The information contained on our web site is not deemed to be a part of this document.

 

Acquisition of Luma Imaging Corporation Assets

 

On November 6, 2007, the Company acquired 100% of the shares of LUMA Imaging Corporation (“LUMA”) from LUMA’s shareholders in consideration for 11.2 million restricted shares of SpectraScience common stock.

 

LUMA had developed and received approval from the U.S. Food and Drug Administration (the “FDA”) for an optical, non-invasive diagnostic imaging system that was proven to more effectively detect cervical cancer precursors than using conventional means alone (i.e. colposcopy). During the fiscal year ended December 31, 2010, the Company wrote off the remaining fair value of LUMA inventory in order to focus on the continued development and marketing of the WavSTAT. The Company retained the intellectual property of LUMA for use in the development of future generations of the WavSTAT System, in particular as it relates to the development of optical detection technology. The intellectual property consisted of a total of approximately 30 issued U.S. patents, certain foreign patents and 28 additional patent applications.

 

Products and Markets

 

SpectraScience has developed a technology platform to instantly determine if tissue is normal, pre-cancerous or cancerous, without the need for a physical biopsy. The Company received FDA approval to market its proprietary and patented WavSTAT3 optical biopsy system capable of determining instantaneously whether colon tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body and without waiting days for pathology results. The Company’s current improved colon diagnostic product, the WavSTAT4, will require future FDA approval in order to be sold in the United States. The WavSTAT4 has a CE mark, is approved for sale, and is in the process of being marketed, in the European Union. The Company plans to develop an esophageal diagnosis application and to explore additional applications for the detection of pre-cancerous and cancerous tissue in various tissues of the body.

 

3  
 

 

The WavSTAT4 Optical Biopsy System operates by using cool, safe UV laser light to optically illuminate and analyze tissue, enabling the physician to make an instant diagnosis during endoscopy when screening for cancer and, if warranted, to begin immediate treatment during the same procedure. The WavSTAT4 uses laser-induced auto-fluorescence to obtain spectral information from tissue at the suspected site. The system is classified as a non-significant risk device which transmits low-level UV laser light energy through an optical fiber to the tissue via the working channel of an endoscope. The tissue in contact with the optical fiber absorbs the light and the resulting tissue auto-fluorescence spectra is collected by the same optical fiber and returned to a detector within the WavSTAT4 console for processing. The system analyzes the spectral data and displays the results graphically for the user as normal tissue (green light), suspected pre-cancerous tissue, or cancerous tissue (red light). Data are recorded and saved redundantly in both flash memory and on a hard drive within the system. The WavSTAT4 has been tested at leading medical centers with results demonstrating statistically significant improvement in physician accuracy in the ability to detect pre-cancerous and cancerous tissue during endoscopy.

 

The WavSTAT Optical Biopsy System was specifically designed to serve as a technology platform to facilitate multiple medical applications for cancer diagnosis. We see additional opportunities for this core technology in esophageal cancer and in several other large as-yet-unexplored markets which include lung, skin, stomach, prostate and bladder cancer diagnosis. The Company is currently exploring these additional applications of its platform for these markets, and is analyzing feasibility of the use of its technology and the revenue opportunity for each market.

 

Colorectal Cancer

 

The American Cancer Society reports colorectal cancer as the third most common cancer diagnosed in the U.S. with approximately 140,000 new cases annually. With an estimated 50,000 deaths annually, colorectal cancer is second only to lung cancer as the leading cause of cancer death in the United States. Candidates for colorectal cancer screening include all persons, with or without symptoms, over the age of 50 (or an estimated 80-90 million people in the U.S.) with the screening market expected to increase 20% over the next ten years. Demographic trends in Europe are very similar.

 

Colorectal cancer is primarily diagnosed through the discovery and histo-pathologic analysis of polyps. Colon polyps are small masses of tissue found in the lining of the colon that may be either benign or malignant. The most commonly performed and generally accepted colorectal cancer screening procedure to detect polyps is an endoscopy of the colon, known as a colonoscopy. According to the American Society for Gastrointestinal Endoscopy guidelines for colorectal cancer screening, large polyps (greater than 1 centimeter) are generally removed as a matter of course and sent to pathology for evaluation. On the other hand, the guidelines further state that small polyps (less than 1 centimeter which account for approximately 85% of all polyps) require, “individualized treatment on a case by case basis”. The clinical utility of the WavSTAT4 occurs when the physician must decide the best course of treatment for small polyps. When small polyps are found, it is left to the physician’s discretion based primarily on visual assessment, whether to remove the polyp, place the patient under surveillance, or to perform a physical biopsy. If a biopsy is performed and cancer or pre-cancer is documented by pathology, the polyp must then be removed. Historically in this context, approximately 70% of the physical biopsies taken are determined to be benign. The WavSTAT4 can significantly reduce the procedure cost and attendant complication rates by immediately classifying these polyps as benign without the need for removal and subsequent pathology. The WavSTAT4 was specifically designed to be used during colonoscopy to aid and improve the physician’s ability to identify small polyps as normal, pre-cancerous or cancerous tissue in real time.

 

4  
 

 

Relative to colorectal cancer, five-year survival rates as reported by the American Cancer Society are as follows:

 

  Approximately 90% of patients live five years or longer if the cancer is detected and treated at an early stage;
   
  Only 70% of patients live five years or longer if the cancer spreads outside the polyp and colon to nearby organs or lymph nodes; and
   
  The five-year survival rate for those patients in whom the cancer has spread further to the liver or other organs is only 12%.

 

Early detection of colorectal cancer is essential to long-term survival. Unfortunately, the American Cancer Society reports that only 39% of colorectal cancers are detected at an early stage. Clinical studies indicate that colorectal cancer screening procedures result in earlier detection and can prevent as many as 20 to 40% of potential colorectal cancers and subsequently reduce colorectal cancer deaths by 30 to 50%. Colorectal screening procedures not only save lives, they also save money. If a patient is not diagnosed until symptoms develop and the disease has spread, or if misdiagnosed at an early stage, the chance of patient survival plummets and more advanced treatment regimens such as surgery, chemotherapy and/or radiation become necessary.

 

Based on the results demonstrated by our own clinical studies, we believe that using the WavSTAT will:

 

  Significantly improve the physician’s diagnostic accuracy in determining whether small polyps in the colon are pre-cancerous or cancerous;
   
  Improve patient survival rates by earlier detection and treatment of cancers, and more importantly pre-cancers, by more accurately identifying cancers or pre-cancers the physician may misdiagnose;
   
  Improve the patient’s quality of life by providing an immediate analysis of the tissue, thereby eliminating the anxiety of waiting several days to hear the pathology results;
   
  Enable the physician to diagnose and treat the patient during the same endoscopy procedure with the same biopsy instrument, thereby potentially reducing the need for scheduling a second expensive endoscopy for treatment purposes;
   
  Significantly reduce the number of physical biopsies performed and reduce the number of unnecessary follow-on endoscopies performed; and
   
  Reduce the number of misdiagnosed patients, thereby eliminating the need for more costly advanced treatments such as surgery, chemotherapy and/or radiation.

 

Esophageal Cancer

 

In February 2016, the Company acquired the assets of Oncoscope from the U.S. Trustee appointed to Oncoscope’s Chapter 7 filing under the United States Bankruptcy Code. In addition, the Company entered into a license agreement with Duke University to make use of certain technology related to esophageal cancer research that had been previously licensed to Oncoscope.

 

Barrett’s esophagus is a condition of the lining of the lower esophagus thought to be caused primarily by Gastro Esophageal Reflux Disease (“GERD”), more commonly known as chronic heartburn. Barrett’s esophagus is considered to be a pre-malignant stage and a precursor to esophageal cancer. Physicians typically recommend that persons with chronic heartburn should have an endoscopy to look for Barrett’s esophagus. Some Barrett’s esophagus patients will advance further to a stage where additional abnormal tissue called dysplasia is present. Dysplasia is known to be the next progressive step toward esophageal cancer and is categorized as either low-grade or high-grade.

 

5  
 

 

Barrett’s esophagus, dysplasia and esophageal cancer patients are presently diagnosed via endoscopy of the esophagus with the physician taking multiple random physical biopsies of the esophageal lining; this is a significantly invasive procedure. It is critical that high-grade dysplasia is correctly diagnosed because physicians frequently recommend surgical resection, radio frequency ablation or removal of the esophagus in such an event. Unfortunately, dysplasia is difficult to find and/or diagnose because it is not reliably visible to the physician during standard endoscopy. The result is that physical biopsies (as many as 20 at once) are performed either randomly or in a geometric pattern in the esophagus in the hope of finding any diseased tissue. Current medical practice typically follows the guidelines described below:

 

  Patients with chronic GERD (severe heartburn) receive a screening endoscopy of the esophagus with multiple biopsies to check for Barrett’s esophagus;
   
  Patients with Barrett’s esophagus receive an endoscopy with multiple biopsies every year to check for dysplasia;
   
  Patients with Barrett’s esophagus that has progressed to include low-grade dysplasia receive an endoscopy with multiple biopsies every six months to check for high-grade dysplasia; and
   
  Patients with Barrett’s esophagus that has progressed to include high-grade dysplasia receive an endoscopy with multiple biopsies every three months to check for cancer and/or may be referred for esophageal surgical resection, photodynamic therapy or electrical (“RF”) ablation.

 

The relatively high death rate associated with esophageal cancer typically results from a lack of early diagnosis with the outcome being that the cancer has grown to an advanced stage. As described above, the frequency of endoscopic surveillance for these patients increases as the pre-cancerous stages advance in hopes of providing the earliest possible diagnosis.

 

Government Regulation

 

Extensive government regulation and standards, both in the United States and internationally, standardize and govern many processes for design, manufacture, labeling, distribution and marketing of our products, particularly regarding product safety and effectiveness. In the United States, medical devices are subject to review and clearance or approval by the FDA. The FDA and international bodies also govern the clinical testing of medical devices. If we fail to comply with applicable requirements prior to marketing the WavSTAT4 system in the United States, we could face:

 

  fines, injunctions or civil penalties;
   
  recall or seizure of our products;
   
  criminal prosecution;
   
  a recommendation that we not be allowed to contract with the government;
   
  total or partial suspension of production;
   
  inability to obtain pre-market clearance/approval for our devices; and
   
  withdrawal of marketing approvals.

 

The Food, Drug, and Cosmetic Act, the Public Health Service Act, and Safe Medical Devices Act of 1990 and other federal statutes and regulations also govern or influence the storage, recordkeeping,, advertising and promotion of such products.

 

6  
 

 

In the United States, medical devices are assigned to one of three classes depending on the controls the FDA deems necessary to ensure the safety and effectiveness of the device. The WavSTAT4 system is a Class III device; this is FDA’s most highly regulated category in the Center for Devices and Radiological Health (“CDRH”).. In addition to adhering to general controls to which all medical devices are subject, and special controls such as performance standards, post-market surveillance and patient registries, a Class III device must receive pre-marketing approval to ensure its safety and effectiveness prior to commercialization. Through our ongoing clinical evaluations, the Company has developed a program to obtain this approval for the WavSTAT4 system in the United States.

 

FDA approval to distribute regulated devices can be obtained in one of two ways. If a new or significantly modified device is “substantially equivalent” to an existing legally marketed device, the new device can be commercially introduced after filing a 510(k) pre-market notification with the FDA and the subsequent issuance by the FDA of an order permitting commercial distribution. Technically, this process is called a marketing “clearance.” Changes to such cleared devices that do not significantly affect safety or effectiveness may be made without an additional 510(k) notification. We received 510(k) clearance from the FDA for our disposable and reusable Optical Biopsy Forceps in December 1996.

 

A second, more comprehensive process applies to a Class III device that is not substantially equivalent to an existing product or has been determined by FDA to be in this Class. Typically, the applicant (Sponsor) must conduct clinical trials in compliance with testing protocols and patient “informed consent” forms approved by an Institutional Review Board (“IRB” or the “Safety Committee”) at each participating research institution. These boards oversee and approve all clinical studies at their institutions (in some cases a central IRB may approve studies at multiple locations). Second, a Pre-Market Approval (“PMA”) application must be submitted to the FDA describing (i) the clinical trial results, (ii) the device and its components, (iii) the methods, facilities and controls used for manufacture of the device, (iv) proposed labeling and advertising literature, and (v) the demonstration that the product is safe and effective.

 

If the FDA determines, upon receipt of the PMA application, that the application is sufficiently complete to permit a substantive review, they will accept the application for filing. Review of a PMA typically takes from six months to two years from the date the application is accepted for filing, but can take longer. Often, during the review period, a panel primarily composed of clinicians and acting as an advisory committee will be convened to review, evaluate, and provide non-binding recommendations to the FDA as to whether the device should be approved. Toward the end of the application review process, the FDA generally will conduct an inspection of the manufacturer’s facilities to ensure that the facilities are compliant with the applicable Quality System Regulations requirements.

 

If FDA evaluations of both the PMA application and the manufacturing facilities are favorable, the FDA will issue either an “approval” letter or a conditional approval letter that contains a number of conditions that must be satisfied in order to secure final approval of the PMA application. When and if those conditions are fulfilled to the satisfaction of the FDA, they will issue the approval letter, authorizing commercial marketing of the device for certain indications for use. If the FDA’s evaluation of the PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the application or issue a “not approvable letter.” The FDA may also determine that additional clinical trials are necessary, in which case pre-market approval could be delayed for several years while additional clinical trials are conducted and submitted in an amendment to the PMA application. In some cases, the FDA may grant approval with a requirement for additional clinical data generated as part of a post-approval requirement. The pre-market approval process can be expensive, uncertain and lengthy, and a number of devices for which FDA approval has been sought have never been approved for marketing.

 

Changes to approved devices are governed by a variety of submission supplement types and typically FDA is involved with most changes, improvements and labeling during the life of Class III products. In addition products manufactured or distributed pursuant to FDA clearances or approvals, are also subject to other pervasive and continuing regulation by the FDA including record-keeping requirements, recall reporting and reports of adverse experiences when using the product. Products exported also have a variety of regulatory requirements to which the company must comply.

 

Device manufacturers are required to register their establishments and list their devices with the FDA and certain state agencies, and are subject to periodic inspections. The Food, Drug, and Cosmetic Act requires devices to be manufactured in accordance with Quality System Requirements (QSR) regulations, which impose procedural and documentation requirements upon a manufacturer and any of its contract manufacturers with respect to manufacturing and quality assurance activities. The regulation and Standard described below also require design controls and maintenance of service and customer complaint records.

 

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The International Standard, ISO 13485, is similar to the FDA’s QSR. The company is also inspected against this standard by a retained “Notified Body.” The frequency and depth of the inspections of PMA products are generally more detailed and frequent than products cleared via the 510(k) process. The company’s past two inspections by the FDA did not result in any adverse findings. Similarly, the company’s ISO inspections have confirmed recertification of our CE Mark for export.

 

Changes in existing requirements or adoption or new requirements or policies could adversely affect our ability to comply with regulatory requirements. Failure to comply with regulatory requirements could have a material adverse effect on our business, financial condition or results of operations.

 

The Company submitted a PMA for market clearance of the WavSTAT Optical Biopsy System for use during endoscopic screening of the colon in September 1998, and was approved by the FDA in November 2000. Based upon beta site outcome clinical studies, features were added to the WavSTAT system, and submitted as a supplement to the original filing in September 2001. The supplement for the WavSTAT2 system was approved by the FDA in November 2001. The Company submitted a supplement for approval of WavSTAT3 system in February 2002 and approval was received in August 2002. We anticipate, but do not know for certain, that product improvements requiring approval, or any new applications, such as for the WavSTAT4 system will be submitted as supplements to the original filing rather than as an original PMA filing.

 

We are also subject to numerous other federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. We are not aware of any manufacturing methods for the WavSTAT4 system that will require extensive or costly compliance with environmental regulations. However, since laws change over time there can be no assurance that (i) we will not be required to incur significant costs to comply with all applicable laws and regulations in the future, or (ii) the impact of changes in those laws or regulations or adoption of new laws and regulations will not have a material adverse effect upon our ability to do business.

 

European Union and Other Countries

 

The European Union encompasses most of the major countries in Europe. The European Union has adopted numerous directives and standards regulating the design, manufacture, clinical trial, labeling, and adverse event reporting for medical devices. The principal directive prescribing the laws and regulations pertaining to medical devices in the European Union is the Medical Devices Directive, 93/42/EEC.

 

As noted above, devices that comply with the requirements of the Medical Devices Directive and applicable International Standards Organization (ISO) standards are entitled to bear the CE mark. SpectraScience compliance has been confirmed by our Notified Body to market and sell our medical device products in the European Union and other countries that accept the CE Mark. Generally, companies must go through the ISO certification process in order to obtain the CE mark. SpectraScience has held the appropriate ISO certifications since July 2000, and the CE mark authorization was formally issued in October 2000. In order to maintain this certification SpectraScience undergoes a yearly audit by our Notified Body. Our last audit was in 2015, when we confirmed the certification for EN 13485:2003, which is the medical device adaptation of the ISO 9001 standard. There can be no assurance that we will be able to maintain international certification or CE mark authorization for our products or product components. Furthermore, even though a device bears the CE Mark, practical complications may arise with respect to market introduction because of differences among countries in areas such as labeling requirements and reimbursement practices. We may be required to spend significant amounts of capital in order to comply with the various regulatory requirements of foreign countries and achieve reasonable payment for our products.

 

Product Research and Development

 

The Company invested significant capital in research and development for the fiscal years ended December 31, 2016 and 2015 as continued improvements were made to the WavSTAT4 Optical Biopsy System. Research and development expenses were approximately $637,000 and $719,000 for the fiscal years ended December 31, 2016 and 2015, respectively.

 

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Compliance with Environmental Laws

 

Management has reviewed the cost of compliance with environmental laws and deemed the cost of such compliance to be immaterial for the fiscal year ended December 31, 2016.

 

Distribution and Sales

 

Our objective is to become a leader in the development and commercialization of advanced minimally-invasive diagnostic products with the capability to differentiate in real-time between healthy, and pre-cancerous or cancerous tissue. During 2015, our sales and marketing efforts have been, and will continue to be focused on marketing the WavSTAT4 System in the colorectal diagnostic market. The WavSTAT4 represents a significant redesign and improvement over previous WavSTATs and the WavSTAT4 was completed and available to market in December 2011. We envision particular emphasis on selling the WavSTAT System in international markets and in June 2012 the Company entered into a distribution agreement with PENTAX Europe GmbH (“PENTAX”), for the sale of the WavSTAT in international markets.

 

Since June 2012, the Company has sold to PENTAX approximately $707,000 of mobile consoles and disposable forceps. PENTAX continues to be a distributor on a non-exclusive basis. We are exploring other distribution channels to develop marketing programs and sell the WavSTAT in the EU. A precondition to broad sales adoption in the major markets of Europe is the completion of a series of marketing evaluations in each of these major markets conducted by key opinion leaders. These evaluations are required to obtain widespread adoption of the WavSTAT System in each European country. We are conducting these multi-national, multi-center studies in order to provide current clinical results and validate economic impact. These evaluations combine both the aspects of clinical efficacy as well as economic impact and are critical data points. During 2017 our focus will be on moving these evaluations to completion.

 

Approximate sales by principal geographic area (as a percentage of sales) for fiscal years ended December 31, 2016 and 2015 were as follows:

 

    2016     2015  
             
Domestic sales     82.0 %     - %
                 
Foreign sales:                
Europe     18.0       100.0  
Total foreign sales     18.0       100.0  
                 
Total  sales     100.0 %     100.0 %

 

Major Customer

 

During the two years ended December 31, 2016 and 2015, we had sales to the following customers which represented greater than 10% of our annual revenue:

 

    December 31,  
    2016     2015  
             
Duke University   $ 4,200     $ -  
AMG   $ 950     $ -  
PENTAX   $ -     $ 6,600  

 

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Third-Party Reimbursement

 

If and when the Company secures FDA approval, we expect to market and sell the WavSTAT4 System primarily through managed care hospitals and clinics. In the United States, the purchasers of medical devices generally rely on Medicare, Medicaid, private health insurance plans, health maintenance organizations and other sources of third party reimbursement for health care costs, to reimburse all or part of the cost of medical devices and/or the procedure in which the devices are used. Significant sales of our products will, in part, be dependent on the availability of adequate reimbursement from these third party payers for procedures carried out using our products. We believe that less invasive procedures generally provide less costly overall therapies compared to conventional drugs, surgery and other treatments. We anticipate hospital administrators and physicians will justify the use of our products by the cost and time saving recognized and clinical benefits that we believe will be derived from the use of our products.

 

Third party payers determine whether to provide coverage for a particular procedure and reimburse health care providers for medical treatment at a fixed rate based on the diagnosis-related group established by the Center for Medicare and Medicaid Services. The fixed rate of reimbursement is based on the procedure performed and is unrelated to the specific type or number of devices used in a procedure. If a diagnosis-related group does not cover a procedure, payers may deny reimbursement. If reimbursement for a particular procedure is approved, third party payers will reimburse health care providers for medical treatment based on a variety of methods, including a lump sum prospective payment system based on a diagnosis-related group or per diem, a blend between the health care provider’s reported costs and a fee schedule, a payment for all or a portion of charges deemed reasonable and customary, or a negotiated per capita fixed payment.

 

Upon product introduction, currently existing available codes can be used to provide a level of reimbursement to users. Management believes however, that currently available reimbursement codes do not adequately reimburse for the anticipated value that optical biopsy technology brings to the medical care system. Optical biopsies in the lower gastrointestinal tract are not currently approved for reimbursement by third-party payers, and there can be no assurance that optical biopsy technology will be approved for any third party reimbursement for use in colorectal cancer screening, even if it proves to play a significant role in improving the endoscopist’s ability to accurately differentiate among polyps in the colon. Recently, a reimbursement code for optical biopsy in the upper gastrointestinal tract (esophagus) was approved, evidence that healthcare providers are accepting this minimally-invasive approach.

 

Demonstrating cost-effectiveness and improved patient outcomes is critical to increasing sales since payers evaluate these factors in determining whether to reimburse for new technologies. Payers may also delay reimbursement decisions for a year or more, even when provided with cost-effectiveness data, while they conduct their own technology assessments. The availability of peer-reviewed literature regarding the technology may help payers in reducing this technology assessment timeline. To promote the dissemination of literature regarding the WavSTAT4 optical biopsy technology, we are working to have published clinical utility and cost/benefit data in peer-reviewed journals.

 

We expect that there will be continued pressure on cost-containment throughout the United States health care system. Cost reduction, cost containment, managed care, and capitation pricing (putting a ceiling on price) are ever more familiar themes within health care. Limits on third-party reimbursements that lead to cuts in reimbursements for new or experimental procedures would affect the ability of smaller companies with new technologies to compete with larger established firms or with established technologies. Lobbying activities are often necessary to broadly introduce these new technologies, but lobbying requires extensive amounts of corporate resources that the Company may not be able to afford.

 

Reimbursement systems in international markets vary by country, and reimbursement approvals must be obtained on a country-by-country basis. Many international markets have government managed health care systems that control reimbursement for new products and procedures. In most markets, there are private insurance systems as well as government-managed systems. Market acceptance of our products will depend on the availability and level of reimbursement in our targeted international markets. We may not be able to obtain reimbursement in any country within a particular time, for a particular time, for a particular amount, or at all.

 

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We are unable to predict what additional legislation or regulation relating to the health care industry or third-party coverage and reimbursement may be enacted in the future, if any, or what effect it might have on us. In particular, we are unable to yet predict the impact that health care reform legislation will have on our business. Reforms include (i) mandated basic health care benefits, (ii) controls on health care spending through limitations on the growth of private health insurance premiums and Medicare and Medicaid spending, (iii) greater reliance on prospective payment systems, (iv) the creation of large insurance purchasing groups, and (v) fundamental changes to the health care delivery system. Management anticipates that Congress and state legislatures will continue to review and assess alternative health care delivery systems and payment mechanisms. Due to uncertainties regarding the ultimate features of reform initiatives and their enactment and implementation, we cannot predict which reform proposals, if any, will be adopted, when they may be adopted or what impact they may have on us. Failure by hospitals and other users of our products to obtain reimbursement from third-party payers, or changes in government and private third-party payers’ policies toward reimbursement for procedures employing our products, could have a material adverse effect on our business, financial condition and results of operations.

 

Manufacturing and Sources of Supply

 

SpectraScience manufactures the WavSTAT4 System at its facility in San Diego. The disposable WavSTAT optical biopsy forceps (one required for each patient) are outsourced to United States contract OEM manufacturers. The Company also performs certain final assembly processes of the WavSTAT forceps. All WavSTAT Systems previously used for pre-clinical testing, FDA compliant clinical trials, and cost effectiveness/outcome clinical studies were manufactured under a Quality System with Standard Operating Procedure controls. Management continues to utilize these quality control systems and adds to or modifies them as necessary. The Company is currently evaluating secondary procurement sources for its products.

 

The WavSTAT4 Systems are, and will be, manufactured in accordance with current FDA Quality System Regulations and EN 13485:2003 International Standards, both of which are necessary to sell products within the United States and the European Union. These requirements impose certain procedural and documentation requirements upon SpectraScience with respect to manufacturing and quality assurance activities, as well as upon those third parties with whom the Company contracts to perform certain manufacturing processes.

 

During 2007, SpectraScience was granted ISO 9001 and 13485:2003 certification for its manufacturing facility and Quality System. These international standards are the European equivalent to the FDA’s Quality System Regulations. Meeting these standards permits use of the CE mark to export the WavSTAT4 Optical Biopsy System to the European Union.

 

The FDA has reviewed the manufacturing processes and Standard Operating Procedures required to build a WavSTAT System and we are authorized to manufacture the product in our current facility. Both the FDA and the European Notified Body will continue to perform periodic audits as long as SpectraScience manufactures and commercializes medical products.

 

Competition

 

The medical device industry is highly competitive. Management believes the Company has few direct competitors in applying spectroscopy for the differentiation of normal, pre-cancerous or cancerous tissues in the gastrointestinal tract; however, the development of products using spectroscopic diagnostics for various medical specialties is expanding. To the best of our knowledge, no other competitors have completed FDA clinical studies or submitted a pre-market approval application to the FDA or received CE Mark authority to distribute a product for the detection of colorectal or esophageal cancer.

 

Many competitors have substantially greater resources than we do, either internally or in combination with strategic partners. These resources may allow them to develop, market and distribute technologies or products that could be more effective than those developed or marketed by us, or that would render our technologies and products obsolete. The resource advantages they may have are:

 

11  
 

 

  greater capital resources;
     
  greater manufacturing resources;
     
  greater resources and expertise in testing products in clinical trials;
     
  greater resources and expertise in the areas of research and development;
     
  greater expertise in obtaining regulatory approvals; and
     
  greater resources for marketing and sales activities.

 

The companies listed below have developed or are in the process of developing products that use light-based spectroscopic technology or similar methods. These companies compete with and could potentially compete with SpectraScience products or technologies. However, none of these companies use a technology or method which is the same as that used by SpectraScience and only one has commercialized a diagnostic application (Mela Sciences, Inc. for skin cancer) that does not require image analysis and physician interpretation.

 

Competitors

 

There are a number of companies with products or developing products that may directly or indirectly compete with our products. Among these companies are Olympus Corporation, Tokyo, Japan; PENTAX, a division of HOYA Corporation, Tokyo, Japan; Fujifilm Corporation, Tokyo, Japan; Mauna Kea Technologies, Paris France; MELA Sciences, Inc. Irvington, NY; Caliber ID, Rochester, NY; Verisante Technology, Inc., Vancouver, British Columbia; Guided Therapeutics, Inc., Norcross, Georgia; and NinePoint Medical, Inc., Cambridge, Massachusetts. Many of these companies have significantly greater resources than we do. In addition, there are other smaller potential competitors working on light-based technologies for detection and diagnosis and several academic centers conducting research.

 

Patents

 

SpectraScience currently owns exclusive rights to a total of 32 issued U.S. utility patents, seven U.S. design patents and approximately 25 foreign counterpart patents. Our most recent patent grant was in August 2012 and we continue to apply for patents to expand and strengthen our intellectual property portfolio. Our U.S. patents are listed below:

 

  Patent Name   U.S. Patent Number
  Optical Biopsy Forceps   5,762,613
  System for Diagnosing Tissue with Guidewire   5,601,087
  Optical Biopsy Forceps System and Method of Diagnosing Tissue   6,066,102
  Optical Biopsy Forceps   6,129,683
  Optical Biopsy System and Methods for tissue Diagnosis   6,174,291
  Optical Forceps System and Method of Diagnosing and Treating Tissue   6,394,964
  Spectral Volume Microprobe Analysis of Materials   5,713,364
  Spectral Volume Microprobe Arrays   6,104,945
  Spectroscopic System Employing a Plurality of Data Types   6,385,484
  Spectral Volume Microprobe Arrays   6,411,835
  Systems and Methods for Optical Examination of Samples   6,411,838
  Spectral Data Classification of Samples   6,421,553
  Optical Methods and Systems for Rapid Screening of the Cervix   6,427,082
  Substantially Monostatic, Substantially Confocal Optical Systems for Examination of Samples   6,760,613
  Fluorescent Fiberoptic Probe for Tissue Health Discrimination and Method of Use Thereof   6,768,918

 

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  Method and Apparatus for Identifying Spectral Artifacts   6,818,903
  Spectral Volume for Microprobe Arrays   6,826,422
  System for Normalizing Spectra   6,839,661
  Optical Probe Accessory Device for Use In-Vivo Diagnostic Procedures   6,847,490
  Methods of Monitoring Effects of Chemical Agents on a Sample   6,902,935
  Optimal Windows for Obtaining Optical Data for Characterization of Tissue Samples   6,933,154
  Methods and Apparatus for Displaying Diagnostic Data   7,136,518
  Colonic Polyp Discrimination by Tissue Florescence and Fiberoptic Probe   7,103,401
  Optical Methods and Systems for Rapid Screening of the Cervix   7,127,828
  Methods and Systems for Correcting Image Misalignment   7,187,810
  Image Processing using Measures of Similarity   7,260,248
  Methods and Apparatus for Processing Spectral Data for use in Tissue Characterization   7,282,723
  Methods and apparatus for characterization of tissue samples   7,309,867
  Fluorescent fiberoptic probe for tissue health discrimination   7,310,547
  Methods and Systems for Correcting Image Misalignment   7,406,215
  Methods and Apparatus for Calibrating Spectral Data   7,459,696
  Unique Methods and Apparatus for Evaluation of Image Focus   7,469,160

 

SpectraScience is also the exclusive licensee through the Massachusetts General Hospital of U.S. Patent 5,843,000 entitled, “Optical Biopsy Forceps and Method of Diagnosing Tissue”. We believe that this patent, in combination with our other optical forceps patents, provides the Company an advantage in marketing biopsy forceps that contain optical fiber. The above patents expire between 2017 and 2027. Each of the international patents designates several countries for patent protection.

 

SpectraScience is also the exclusive licensee through Duke University of certain technology known as #2523- “Systems and Methods for Endoscopic Angle-resolved Low Coherence Interferometry”, #2819- “Systems and Methods for Angle-Resolved Low Coherence Interferometry”, and #3307- “Single Mode-Fiber Base Angle Resolved Low Coherence Interferometric System for Light Scattering Measurement.” This technology provides the Company an advantage in marketing the esophageal cancer diagnostic products.

 

The Company believes that it holds one of the strongest patent portfolios of its kind in the field of optical methods for the diagnosis and detection of tissue abnormalities, particularly for identifying cancer and its precursors. Management also believes that its intellectual property portfolio will protect the core technology and methods embodied in the WavSTAT4 Optical Biopsy System as well as for many of the Company’s future products and can create a substantial barrier to entry for others pursuing similar approaches.

 

Core Areas of Patent Protection

 

SpectraScience’s portfolio provides protection in the following key technology, design and methods areas:

 

  Localized tissue characterization using optical methods;
   
  Specific application and combinations of auto-fluorescence, broadband spectroscopy and video imaging;
   
  Design and use of disposable components, in combination with systems and methods, including use of unique identifiers;
   
  Algorithms specific to optical assessment of tissue characteristics, particularly involving identification, classification and calibration methods;
   
  Clinical applications of these methods and systems for identifying tissue characteristics, including use of display methods, marking methods (including biomarkers) and in combination with treatment; and
   
  Applications to further future system development, including applications for screening, treatment and other applications beyond colon and esophageal cancer.

 

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SpectraScience holds registered trademarks for the WavSTAT System and SpectraScience trade names, and software and graphics are protected by appropriate copyrights.

 

Our ability to obtain and maintain patent protection for our products, preserve our trade secrets and operate without infringing on the proprietary rights of others will directly affect how successful our operations will be. Our strategy regarding the protection of our proprietary rights and innovations is to seek patents on those portions of our technology that we believe are patentable, and to protect as trade secrets other confidential information and proprietary know-how. SpectraScience is careful to protect its trade secrets and proprietary know-how by obtaining confidentiality and invention assignment agreements in connection with employment, consulting and advisory relationships. There are certain technological aspects of the WavSTAT Systems that are not covered by any patents or patent applications.

 

The patent and trade secret positions of medical device companies like SpectraScience are uncertain and involve complex and evolving legal and factual questions. To date, no claims have been brought against the Company alleging that our technology or products infringe intellectual property rights of others. Often, patent and intellectual property disputes in the medical device industry are settled through licensing or similar arrangements. However, necessary licenses from other parties may not be available to us on satisfactory terms, if at all, and the costs associated with such arrangements may be substantial and could include ongoing royalties.

 

United States patent applications are not publicly disclosed until they are issued or corresponding foreign applications are published in other countries. Since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, management cannot be certain that SpectraScience was the first to invent the inventions covered by each of its pending patent applications, or that it was the first to file patent applications for such inventions. In addition, the laws of some foreign countries do not provide the same degree of intellectual property-rights protection as do the laws of the United States. Litigation associated with patent or intellectual property infringement or protection could be lengthy and prohibitively costly. SpectraScience may not have the financial resources to defend its patents from infringement or claims of invalidity, or to successfully defend itself against intellectual property infringement claims by third parties.

 

Product Liability

 

The risk of product liability claims, product recalls and associated adverse publicity is inherent in the manufacturing, marketing and sale of medical products. We have clinical trial liability insurance coverage for our clinical programs however, there can be no assurance that future insurance coverage will be adequate or available. We may not be able to secure product liability insurance coverage on acceptable terms or at reasonable costs when needed. Any liability damages could exceed the amount of our coverage. A successful product liability claim against us could require us to pay a substantial monetary award. Moreover, a product recall could generate substantial negative publicity about our products and business and inhibit or prevent commercialization of other future products.

 

Employees

 

As of March 31, 2017, SpectraScience has five full-time and four part-time employees and consultants, with five involved in manufacturing/engineering, one in sales and marketing and three in finance and administration. The Company’s payroll has been administered by an independent third party. SpectraScience is not subject to any collective bargaining agreement and management believes that employee relations are generally satisfactory.

 

SpectraScience also relies on external consultants in the financial, regulatory, software development and design engineering areas. In the future, if management decided to increase our workforce in response to improved economic, market, and/or business conditions, we might not be able to attract or retain employees with the skills we require.

 

ITEM 1A. RISK FACTORS.

 

We describe below a number of uncertainties and risks which, in addition to uncertainties and risks presented elsewhere in this annual report, may adversely affect our business, operating results and financial condition. The uncertainties and risks enumerated below as well as those presented elsewhere in this annual report should be considered carefully in evaluating our company and our business and the value of our securities.

 

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RISKS RELATED TO OUR BUSINESS

 

We have a limited operating history with significant losses and expect losses to continue for the foreseeable future.

 

We have yet to establish any history of profitable operations. We have incurred annual operating losses of approximately $2,444,000 and $2,483,000, respectively, during the past two years of operations. As a result, at December 31, 2016 we had an accumulated deficit of approximately $53,966,000. We have incurred net losses from continuing operations of approximately $4,467,000 and $3,635,000 for the years ending December 31, 2016 and 2015, respectively. Our revenues have not been sufficient to sustain our operations and we expect that they will be insufficient to sustain our operations for the foreseeable future. Our failure to generate meaningful revenues and ultimately profits from the WavSTAT System and applications of our technology could and will likely require that we raise additional capital which may not be available or available on acceptable terms. This could ultimately reduce or suspend our operations and ultimately cause us to go out of business. Our profitability will require the successful commercialization of our imaging systems and no assurances can be given when this will occur or if we will ever be profitable.

 

We will require additional financing to sustain our operations and without it, we may not be able to continue operations.

 

At December 31, 2016, we had a working capital deficit of approximately $10,440,000. We had an operating cash flow deficit of approximately $1,513,000 for the year ended December 31, 2016 and an operating cash flow deficit of approximately $1,890,000 in 2015. We may not have sufficient financial resources to fund our operations and will likely require additional funds to continue our operations.

 

We may face intense competition from companies that have greater financial, personnel and research and development resources.

 

Competitive forces may impact our projected growth and ability to generate revenues and profits, which would have a negative impact on our business and the price of our common stock. Our competitors may be developing products that compete with the WavSTAT Systems. Our commercial opportunities would then be reduced or eliminated should our competitors develop and market products for any of the diseases that we target that are more effective or are less expensive than the products or product candidates we are developing.

 

Even if we are successful in developing an effective WavSTAT System, and we obtain FDA and other regulatory approvals necessary for commercialization, our products may not compete effectively with other successful products. Researchers are continually learning more about diseases, which may lead to new technologies and tools for analysis.

 

Our competitors include fully integrated medical device companies, universities and public and private research institutions. Many of the organizations competing with us may have substantially greater capital resources, larger research and development staffs and facilities, greater experience in product development and in obtaining regulatory approvals, and greater marketing capabilities than we do.

 

The market for medical devices is intensely competitive. Many of our potential competitors have longer operating histories, greater name recognition, more employees, and significantly greater financial, technical, marketing, public relations, and distribution resources than we have. This intense competitive environment may require us to make changes in our products, pricing, licensing, services or marketing to develop, maintain and extend our current technology. Price concessions or the emergence of other pricing or distribution strategies of competitors may diminish our revenues, adversely impact our margins or lead to a reduction in our market share, any of which may harm our business.

 

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Our WavSTAT System technology may become obsolete.

 

Our WavSTAT System products may be made unmarketable by new scientific or technological developments where new treatment modalities are introduced that are more efficacious or more economical. Any one of our competitors could develop a more effective product which would render our technology obsolete.

 

Our inability to attract and retain qualified personnel could impede our ability to generate revenues and profits and to otherwise implement our business plan and growth strategies, which would have a negative impact on our business and could adversely affect the price of our common stock.

 

We currently have a staff of nine employees and consultants, consisting of, among others, our Chief Executive Officer, Chief Financial Officer, Director of Sales and Marketing and Chief Engineer Director, as well as administrative employees. We will be required over the longer-term to hire highly skilled managerial, scientific and administrative personnel to fully implement our business plan and growth strategies. We cannot assure you that we will be able to engage the services of such qualified personnel at competitive prices or at all, particularly given the risks of employment attributable to our limited financial resources and lack of an established track record.

 

Our planned growth will place strains on our management team and other company resources to both implement more sophisticated managerial, operational and financial systems, procedures and controls and to train and manage the personnel necessary to perform those functions. Our inability to manage our growth could impede our ability to generate revenues and profits and to otherwise implement our business plan and growth strategies, which would have a negative impact on our business and the market value of the Company.

 

We will need to significantly expand our operations to implement our longer-term business plan and growth strategies. We will also be required to manage multiple relationships with various strategic partners, technology licensors, customers, manufacturers and suppliers, consultants and other third parties. This expansion and these expanded relationships will require us to significantly improve or replace our existing managerial, operational and financial systems, procedures and controls; to improve the coordination between our various corporate functions; and to manage, train, motivate and maintain a growing employee base. The time and costs to effectuate these steps may place a significant strain on our management personnel, systems and resources, particularly given the limited amount of financial resources and skilled employees that may be available at the time. We cannot assure you that we will institute, in a timely manner or at all, the improvements to our managerial, operational and financial systems, procedures and controls necessary to support our anticipated increased levels of operations and to coordinate our various corporate functions, or that we will be able to properly manage, train, motivate and retain the anticipated increased number of employees.

 

We may have difficulty in developing and retaining an effective sales force or in obtaining effective distribution partners and may not be able to achieve sufficient revenues to affect our business plan.

 

The market for skilled sales and marketing personnel is highly competitive and specialized. If we are unable to hire and retain skilled and knowledgeable sales people it may negatively impact our ability to introduce our products or generate revenue sufficient to affect our future business plans. In addition, our inability to develop business relationships with key technical distributors may also negatively impact our ability to successfully market our products.

 

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We may have difficulty in attracting and retaining management and outside independent members to our Board of Directors as a result of their concerns relating to their increased personal exposure to lawsuits and shareholder claims by virtue of holding these positions in a publicly held company.

 

The directors and management of publicly traded corporations are increasingly concerned with the extent of their personal exposure to lawsuits and shareholder claims, as well as governmental and creditor claims which may be made against them, particularly in view of recent changes in securities laws imposing additional duties, obligations and liabilities on management and directors. Due to these perceived risks, directors and management are also becoming increasingly concerned with the availability of directors and officers liability insurance to pay on a timely basis the costs incurred in defending such claims. We currently carry directors’ and officers’ liability insurance, but such insurance is expensive and can be difficult to obtain. If we are unable to obtain directors and officers liability insurance at affordable rates or at all in the future, it may become increasingly more difficult to attract and retain qualified outside directors to serve on our board of directors. The fees of directors are also rising in response to their increased duties, obligations and liabilities as well as increased exposure to such risks. As a company with a limited operating history and limited resources, we will have a more difficult time attracting and retaining management and outside independent directors than a more established company due to these enhanced duties, obligations and liabilities.

 

If we fail to comply with extensive regulations enforced by domestic and foreign regulatory authorities, the commercialization of our products could be prevented or delayed.

 

Our WavSTAT Systems are subject to extensive government regulations related to development, testing, manufacturing and commercialization in the United States and other countries. The determination of when and whether a product is ready for large scale purchase and potential use will be made by the government through consultation with a number of governmental agencies, including the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention. Some of our product candidates are in the clinical stages of development and have not received required regulatory approval from the FDA for applications we hope to commercially market. The process of obtaining and complying with the FDA and other governmental regulatory approvals and regulations is costly, time consuming, uncertain and subject to unanticipated delays. Despite the time and expense incurred, regulatory approval is never guaranteed. We also are subject to the following risks and obligations, among others:

 

  The FDA may refuse to approve an application if they believe that applicable regulatory criteria are not satisfied;
     
  The FDA may require additional testing for safety and effectiveness;
     
  The FDA may interpret data from pre-clinical testing and clinical trials in different ways than us;
     
  If regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution; and
     
  The FDA may change their approval policies and/or adopt new regulations.

 

Failure to comply with these or other regulatory requirements of the FDA may subject us to administrative or judicially imposed sanctions, including:

 

  Warning letters;
     
  Civil penalties;
     
  Criminal penalties;
     
  Injunctions;
     
  Product seizure or detention;
     
  Product recalls; and
     
  Total or partial suspension of production.

 

17  
 

 

Delays in successfully completing our clinical and European evaluation trials could jeopardize our ability to obtain regulatory approval or market our WavSTAT System candidates on a timely basis.

 

Our business prospects will depend on our ability to complete clinical trials, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our WavSTAT System product candidates. Completion of our clinical trials, announcement of results of the trials and our ability to obtain regulatory approvals could be delayed for a variety of reasons, including:

 

  Unsatisfactory results of any clinical trial;
     
  The failure of principal third-party investigators to perform clinical trials on our anticipated schedules; and
     
  Different interpretations of pre-clinical and clinical data, which could initially lead to inconclusive results.

 

Our development costs will increase if we have material delays in any clinical trial or if we need to perform more or larger clinical trials than planned.

 

If clinical or evaluation trial delays are significant, or if any of our WavSTAT System product candidates do not prove to be safe or effective or do not receive required regulatory approvals, our financial results and the commercial prospects for our product candidates will be harmed. Furthermore, our inability to complete our clinical trials in a timely manner could jeopardize our ability to obtain regulatory approval.

 

The independent clinical investigators that we rely upon to conduct our clinical trials may not be diligent, careful or timely, and may make mistakes, in the conduct of our clinical trials.

 

We depend on independent clinical investigators to conduct our clinical trials. The investigators are not our employees, and we cannot control the amount or timing of resources that they devote to our product development programs. If independent investigators fail to devote sufficient time and resources to our product development programs, or if their performance is substandard, it may delay FDA approval of our products. These independent investigators may also have relationships with other commercial entities, some of which may compete with us. If these independent investigators assist our competitors at our expense, it could harm our competitive position.

 

Our product development efforts may not yield marketable products due to results of studies or trials, failure to achieve regulatory approvals or market acceptance, proprietary rights of others or manufacturing issues.

 

Our success depends on our ability to successfully develop and obtain regulatory approval to market new products. We expect that a significant portion of the research that we will conduct will involve new and unproven technologies. Development of a product requires substantial technical, financial and human resources even if the product is not successfully completed.

 

Potential products may appear to be promising at various stages of development yet fail to reach the market for a number of reasons, including the:

 

  Lack of adequate quality or sufficient prevention benefit, or unacceptable safety during pre-clinical studies or clinical trials;
     
  Failure to receive necessary regulatory approvals;
     
  Existence of proprietary rights of third parties; and/or
     
  Inability to develop manufacturing methods that are efficient, cost-effective and capable of meeting stringent regulatory standards.

 

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Our inability to protect our intellectual property rights could negatively impact our projected growth and ability to generate revenues and profits, which would have a negative impact on our business.

 

We rely on a combination of patent, patent pending, copyright, trademark and trade secret laws, proprietary rights agreements and non-disclosure agreements to protect our intellectual properties. These measures may not prove to be effective in protecting our intellectual properties.

 

In the case of patents, our existing patents may be invalidated, any patents that we currently or prospectively have applied for may not be granted, or any of these patents may not ultimately provide significant commercial benefits. Further, competing companies may circumvent any patents that we may hold by developing products which closely emulate but do not infringe our patents. While we currently have and intend to seek patent protection for our products in selected foreign countries, those patents may not receive the same degree of protection as they would in the United States. We may not be able to successfully defend our patents and proprietary rights in any action we may file for patent infringement. Similarly, we may be required to defend litigation involving the patents or proprietary rights of others, or we may be able to obtain licenses for these rights. Legal and accounting costs relating to prosecuting or defending patent infringement litigation may be substantial.

 

The WavSTAT System is protected by 32 issued patents, in the United States and approximately 25 foreign patents, which we own, and two additional patents for which we own the exclusive license. We also rely on proprietary designs, technologies, processes and know-how not eligible for patent protection. Our competitors may independently develop the same or superior designs, technologies, processes and know-how.

 

While we have and will continue to enter into proprietary rights agreements with our employees and third parties giving us proprietary rights to certain technology developed by those employees or parties while engaged by the Company, courts of competent jurisdiction may not enforce those agreements.

 

The patents we own comprise a large portion of our assets, which could limit our financial viability.

 

Our patents comprise approximately 74% of our assets at December 31, 2016. If our existing patents are invalidated or if they fail to provide significant commercial benefits, it will severely hurt our financial condition, as a significant percentage of our assets would lose their value. Further, since our patents are amortized over the course of their term until they expire, our assets comprised of patents will continually be written down to zero.

 

Legislative actions and potential new accounting pronouncements are likely to impact our future financial position and results of operations.

 

Compliance with publicly-traded company regulations adversely impacts our resources. As a publicly-traded company, we are subject to rules and regulations that increase our legal and financial compliance costs, make some activities more time-consuming and costly, and divert our management’s attention away from the operation of our business. We are obligated to file with the U.S. Securities and Exchange Commission, or the SEC, annual and quarterly information and other reports that are specified in the Securities Exchange Act of 1934, or the Exchange Act, and are also subject to other reporting and corporate governance requirements, including requirements of the Sarbanes-Oxley Act of 2002, and the rules and regulations promulgated thereunder, which impose significant compliance and reporting obligations upon us. We may not be successful in complying with these obligations, and compliance with these obligations could be time consuming and expensive. Failure to comply with the additional reporting and corporate governance requirements could lead to fines imposed on us, deregistration under the Exchange Act and, in the most egregious cases, criminal sanctions could be imposed.

 

Our products may be subject to recall or product liability claims.

 

Our WavSTAT System products may be used in connection with medical procedures in which it is important that those products function with precision and accuracy. If our products do not function as designed, or are designed improperly, we may be forced by regulatory agencies to withdraw such products from the market. In addition, if medical personnel or their patients suffer injury as a result of any failure of our products to function as designed, or due to an inappropriate design, we may be subject to lawsuits seeking significant compensatory and punitive damages. Any product recall or lawsuit seeking significant monetary damages may have a material effect on our business and financial condition.

 

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ITEM 1B. UNRESOLVED STAFF COMMENTS.

 

None

 

ITEM 2. PROPERTIES.

 

SpectraScience leases its principal facility from an unrelated third party. The facility is located at 11568-11 Sorrento Valley Road, San Diego, California 92121, and is well maintained and approved by the FDA for manufacturing. The facility consists of approximately 5,080 square feet of office, research and development, manufacturing, quality testing, and warehouse space. The lease provides for monthly rental payments ranging from $4,826 to $5,432 through April 2018, plus a pro rata share of operating expense and real estate taxes (approximately $1,500 per month). We believe that our present facility is adequate for our needs for the foreseeable future. In the event of the termination of this lease, we believe that we could lease other acceptable space on a comparable basis.

 

ITEM 3. LEGAL PROCEEDINGS.

 

Oakmore Suit

 

On July 7, 2016, Oakmore Opportunity Fund I LP, a variable rate noteholder of SprectraScience, filed for a preliminary judgement of $116, 500 in the Superior Court for the County of Los Angeles, case number BC622542, related to a Convertible Note. Oakmore asserts that SpectraScience breached the terms of the Convertible Note due to not having sufficient authorized shares to enable Oakmore to convert its Note with a balance of $22,500. The Company did not object to the preliminary judgement. On October 19, 2016, the Judge issued a final judgement of $521,100. The Company is retaining litigation counsel and intends to vigorously defend the amount of the judgement. The amount of ultimate liability with respect to the foregoing cannot be determined, however, the Company has established a $150,000 contingency to cover the costs of litigation and the judgement. Despite the inherent uncertainties of litigation, the Company at this time does not believe that Oakmore’s claim will have a material adverse impact on its financial condition, results of operations, or cash flows.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

None.

 

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PART II

 

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information

 

Our Common Stock is quoted on the OTCQB under the symbol SCIE.QB. The last reported closing price of the Common Stock on March 24, 2017 was $0.0007.

 

The following table sets forth for the calendar period indicated; the quarterly closing prices of our Common Stock as reported by the OTCBB and the OTCQB, the bulletin boards on which our common stock was traded during fiscal years 2016 and 2015.

 

    Closing Price  
    High     Low  
             
Year Ended December, 2016                
First Quarter   $ 0.0081     $ 0.0006  
Second Quarter   $ 0.0056     $ 0.0024  
Third Quarter   $ 0.0042     $ 0.0024  
Fourth Quarter   $ 0.0038     $ 0.0011  
                 
Year Ended December, 2015                
First Quarter   $ 0.0300     $ 0.0100  
Second Quarter   $ 0.0300     $ 0.0200  
Third Quarter   $ 0.0200     $ 0.0100  
Fourth Quarter   $ 0.0100     $ 0.0010  

 

On March 31, 2017, we had approximately 800 shareholders of record of our common stock.

 

To date, we have not declared or paid cash dividends on our common stock. The current policy of the board of directors is to retain any earnings to fund the development and growth of our business. Any future determination to pay cash dividends will be at the discretion of our board of directors, and will be dependent upon our financial condition, results of operations, capital requirements and other factors our board may deem relevant at the time.

 

Recent Sales of Unregistered Securities

 

During the quarter ended December 31, 2016, we issued the following equity securities:

 

        Number of              
    Date of   Common Shares     Source of        
Common Stock   Issuance   Issued     Payment     Amount  
    Various     139,646,222       Convertible Debt Conversion     $ 241,632  
                             
Common Stock
Purchase Warrants
Issued For Services
 
 
Date of
Issuance
 
 
 
 
 
Number of Shares
 
 
 
 
 
 
 
Exercise Price
 
 
 
 
 
 
 
Expiration Date
 
 
    11/1/2016     222,222     $ 0.0900       11/1/2021  
    11/1/2016     666,667     $ 0.0600       11/1/2021  

 

21  
 

 

With respect to the above equity securities issuances, the Company relied on exemptions provided by Sections 4(a)(2) and 3(a)9 of the Securities Act of 1933, as amended (the “Securities Act”). No advertising or general solicitation was employed in offering the securities. The securities were issued to a limited number of persons all of whom were accredited investors as that term is defined in Rule 501 of Regulation D under the Securities Act. All were capable of analyzing the merits and risks of their investment, acknowledged in writing that they were acquiring the securities for investment and not with a view toward distribution or resale, and understood the speculative nature of their investment. All securities issued contained a restrictive legend prohibiting transfer of the shares except in accordance with federal securities laws.

 

ITEM 6. SELECTED FINANCIAL DATA

 

Not required.

 

  ITEM 7: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis provides information that management believes is relevant to assess and understand our results of operations and financial condition. This discussion should be read in conjunction with the consolidated financial statements and footnotes that follow such consolidated financial statements.

 

Certain statements contained in this Annual Report on Form 10-K, including in this Item 7, that are not related to historical results, including, without limitation, statements regarding our business strategy and objectives, near term operating goals, our expectations regarding the market for our products and beliefs with respect to opportunities, strategic partnerships and industry conditions in those markets, our beliefs about our products and expectations with respect to their performance and acceptance, regulatory practices and developments, our beliefs about our employees, our beliefs and intentions with respect to intellectual property, our beliefs with respect to reimbursement, our beliefs and expectations regarding competition, future operating losses and our future financial position, our expectations with respect to future cash needs and the sufficiency of our working capital, and estimated cost savings, are forward-looking statements and involve risks and uncertainties. Although we believe that the assumptions on which these forward-looking statements are based are reasonable, such assumptions may not prove to be accurate and actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, changes in law or regulatory policies, unanticipated competition from other similar businesses, adverse outcomes from litigation, unexpected employee departures or disruptions, adverse market and general economic factors and other factors described in Item 1A of this Form 10-K. All forward-looking statements contained in this Form 10-K are qualified in their entirety by this statement.

 

Plan of Operation

 

During the year ended December 31, 2016, SpectraScience continued improvements made to the WavSTAT4 under its distribution agreement with PENTAX Europe, GmbH (“PENTAX”), for distribution of its products in Europe, the Middle East and Africa.

 

22  
 

 

Over the next 12 months, SpectraScience intends to:

 

    Market and sell the WavSTAT4 Optical Biopsy System colon cancer diagnostic application through PENTAX and other distribution channels in the European Union;
     
    Conduct country-specific evaluation trials to demonstrate the effectiveness and cost benefit of the WavSTAT4 Optical Biopsy System in each relevant European jurisdiction;
     
    Coordinate the creation and publication of scientific papers and presentations related to the country-specific evaluation trials to support widespread education and adoption of the WavSTAT4 ;
     
    Pursue the introduction of the WavSTAT4 colon cancer application in other international markets, in particular China, the Middle East and India;
     
    Begin meeting with the FDA towards the preparation and submission of a Supplemental PMA filing with the FDA and plan for additional clinical trials to support eventual approval for sale in the United States;
     
    Begin the design and planning for the next generation of multi-modal fluorescence and broadband spectroscopy systems at our facility in San Diego, California.
     
    Continue to expand and refine our intellectual property portfolio.

 

Cash Requirements

 

SpectraScience expects to incur significant additional operating losses through 2017, as we continue with outcome-based clinical studies, research and development activities and ramp up sales and marketing efforts to sell the WavSTAT4 Systems. We may incur unexpected expenses, or we may not be able to meet our revenue forecast, and such events will require us to seek additional capital.

 

SpectraScience has financed its capital requirements principally through the private sale of equity securities. The Company had cash balances of approximately $4,000 at December 31, 2016 and $128,000 at December 31, 2015. The approximate $124,000 decrease in cash for the year was a result of approximately $1,513,000 of cash used in operations offset by net proceeds from the sale of convertible debentures and debt of approximately $1,389,000. The Company will have to raise additional cash to provide working capital to execute its present business plans.

 

SpectraScience’s future liquidity and capital requirements will depend upon a number of factors, including but not limited to:

 

    The timing and progress of market evaluation clinical trials;
     
    The timing and extent to which SpectraScience’s products gain market acceptance;
     
    The timing and expense of developing marketing and strategic distribution channels;
     
    The progress and expense of developing next generation products and new applications for incorporation into the WavSTAT Optical Biopsy Systems;
     
    The potential requirements and related costs for product modifications;
     
    The timing and expense of various U.S. and foreign regulatory filings;
     
    The maintenance of various U.S. and foreign government approvals, or the timing of receipt of additional approvals;
     
    The status, maintenance and enhancement of SpectraScience’s patent portfolio; and
    The overall effect of global economic conditions, in particular the uncertainty within the economies of the European Union, or the ability of the Company to generate sales revenue.

 

23  
 

 

Results of Operations

 

The following discussion should be read in conjunction with the consolidated Financial Statements and Notes thereto appearing elsewhere in this report.

 

Comparison of years ended December 31, 2016 and December 31, 2015

 

    Year Ended December 31,     Favorable        
    2016     2015     (Unfavorable)     %  
                         
Revenue   $ 5,150     $ 6,600     $ (1,450 )     -22.0 %
Cost of revenue     199,405       602       (198,803 )     -33023.8 %
Gross profit (loss)     (194,255 )     5,998       (200,253 )     -3338.7 %
                                 
Operating expenses:                                
Research and development     636,622       719,210       82,588       11.5 %
General and administrative     1,244,954       1,475,809       230,855       15.6 %
Sales and marketing     368,355       294,353       (74,002 )     -25.1 %
      2,249,931       2,489,372       239,441       9.6 %
                                 
Loss from operations     (2,444,186 )     (2,483,374 )     39,188       -1.6 %
                                 
Other (expense)     (2,022,381 )     (1,151,494 )     (870,887 )     75.6 %
                                 
Net loss   $ (4,466,567 )   $ (3,634,868 )   $ (831,699 )     22.9 %

 

Revenues

 

There were revenues of $5,150 for the year ended December 31, 2016 compared to $6,600 in revenue for the year ended December 31, 2015. We anticipate that revenue will increase on the conclusion of clinical trials and acceptance of our products.

 

Cost of Revenue

 

Cost of revenue for the year ended December 31, 2016 increased $198,803 to $199,405 from $602 for the year ended December 31, 2015. The primary reason for this increase was the establishment of an inventory reserve of approximately $196,000 as a result of the delayed commercialization of the WavSTAT awaiting long term financing. We anticipate that cost of revenue will increase on the conclusion of clinical trials and acceptance of our products.

 

Research and Development Expenses

 

Research and development expenses decreased by $82,588, 11.5%, to $636,622 for the year ended December 31, 2016 from $719,210 for the year ended December 31, 2015. This decrease was primarily due to a decrease in clinical studies of approximately $82,000. We anticipate that development costs will remain low but that clinical costs will increase as we proceed with our introduction of the WaveSTAT4 in Europe.

 

General and Administrative Expenses

 

General and administrative expenses decreased by $230,855, 15.6%, to $1,244,954 for the year ended December 31, 2016 from $1,475,809 for the year ended December 31, 2015. The primary reason for the decrease was a decrease in payroll costs of approximately $218,000. We anticipate that general and administrative expenses will increase as we increase our selling activity in Europe.

 

24  
 

 

Sales and Marketing Expenses

 

Sales and marketing expenses increased by $74,002, 25.1%, to $368,355 for the year ended December 31, 2016 from $294,353 for the year ended December 31, 2015. The primary reasons for the increase were an increase in payroll costs of approximately $47,000 and an increase in travel related expenses of approximately $18,000. We anticipate that sales and marketing expenses will increase as we increase our activity in Europe.

 

Other (Expense)

 

Other (expense) for the year ended December 31, 2016 was expense of $2,022,381 compared to $1,151,494 for the year ended December 31, 2015. This change was due primarily to the change in valuation of our derivative liabilities and the profit and loss recognized on the issuance and extinguishment of our debt. We anticipate continued large fluctuations in other (expense) income as a result of quarterly re-evaluating these obligations.

 

Liquidity and Capital Resources

 

    As of     Increase  
    December 31, 2016     December 31, 2015     (Decrease)  
Working Capital                        
                         
Current assets   $ 361,853     $ 530,746     $ (168,893 )
Current liabilities     10,801,550       8,855,346       1,946,204  
Working capital deficit   $ (10,439,697 )   $ (8,324,600 )   $ 2,115,097  
                         
Long-term debt   $ 1,100,000     $ -     $ 1,100,000  
                         
Shareholders' deficit   $ (10,546,033 )   $ (7,019,662 )   $ 3,526,371  
                         
      Year Ended December 31,       Increase  
      2016       2015       (Decrease)  
Statements of Cash Flows Select Information                        
                         
Net cash provided (used) by:                        
Operating activities   $ (1,512,731 )   $ (1,889,786 )   $ (377,055 )
Investing activities   $ -     $ -     $ -  
Financing activities   $ 1,388,788     $ 1,793,750     $ (404,962 )
                         
      As of December 31,       Increase  
      2016       2015       (Decrease)  
Balance Sheet Select Information                        
                         
Cash   $ 3,550     $ 127,493     $ (123,943 )
                         
Accounts receivable   $ 950     $ 7,061     $ (6,111 )
                         
Inventory   $ 90,594     $ 261,887     $ (171,293 )
                         
Accounts payable and accrued expenses   $ 3,596,779     $ 2,352,439     $ 1,244,340  

 

25  
 

 

Historically, the Company’s sources of cash have come from the issuance and sales of equity securities and convertible debentures. The Company’s historical cash outflows have been primarily used for operating activities including research, development, administrative and sales activities. Fluctuations in the Company’s working capital due to timing differences of its cash receipts and cash disbursements also impact its cash flow. The Company expects to incur significant additional operating losses through at least the end of 2017, as it completes proof-of-concept trials, conducts outcome-based clinical studies and increases sales and marketing efforts to commercialize the WavSTAT4 Systems in Europe. The Company may incur unknown expenses or may not be able to meet its revenue forecast, and one or more of these circumstances would require the Company to seek additional capital. The Company may not be able to obtain equity capital or debt funding on terms that are acceptable. Even if the Company receives additional funding, such proceeds may not be sufficient to allow the Company to sustain operations until it becomes profitable and begins to generate positive cash flows from operations. This raises substantial doubt about the Company’s ability to continue as a going concern.

 

As of December 31, 2016, the Company had a working capital deficit of $10,439,697 and cash of $3,550, compared to a working capital deficit of $8,324,600 and cash of $127,493 as of December 31, 2015. In December 2011, the Company entered into an Engagement Agreement with Laidlaw & Company (UK) Ltd., which Engagement Agreement was amended in July 2012. Under the Engagement Agreement, Laidlaw agreed to assist the Company in raising up to $20.0 million in capital over a two year period from the date of the Engagement Agreement. Subsequent to June 30, 2013, the Company has engaged another agent to assist it with raising capital and has commenced raising capital on its own. For the year ended December 31, 2016, the Company raised approximately $1,455,000 under various funding agreements. However, if the Company does not receive additional funds in a timely manner, the Company could be in jeopardy as a going concern. The Company may not be able to find alternative capital or raise capital or debt on terms that are acceptable. Management believes that if the events defined in the various funding agreements occur as expected, such proceeds will be sufficient to allow the Company to sustain operations until it attains profitability and positive cash flows from operations. However, the Company may incur unknown expenses or may not be able to meet its revenue expectations requiring it to seek additional capital. In such event, the Company may not be able to find capital or raise capital or debt on terms that are acceptable.

 

Off Balance Sheet Arrangements

 

The Company has no off balance sheet arrangements.

 

Critical Accounting Policies and Estimates

 

This discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate these estimates, including those related to intangibles, income taxes, financing operations, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

We have identified the policies below as critical to our business operations and the understanding of our results of operations. The impact and any associated risks related to these policies on our business operations is discussed throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations where such policies affect our reported and expected financial results. Note that our preparation of this Report on Form 10-K requires us to make estimates and assumptions that affect the reported amount of assets and liabilities, disclosure of contingent assets and liabilities at the date of our consolidated financial statements, and the reported amount of revenue, if any, and expenses during the reporting period. Actual results may differ from those estimates.

 

26  
 

 

Revenue Recognition

 

We recognize revenues when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. Revenue from the sale of our products is generally recognized when title and risk of loss transfers to the customer, the terms of which are generally free-on-board shipping point. We use customer purchase orders to determine the existence of an arrangement. We use shipping documents and third-party proof of delivery to verify that title has transferred. We assess whether the fee is fixed or determinable based upon the terms of the agreement associated with the transaction. To determine whether collection is probable, we assess a number of factors, including past transaction history with the customer and the creditworthiness of the customer.

 

Stock Based Compensation

 

We account for stock-based compensation under the provisions of FASB ASC Topic 718, Compensation—Stock Compensation, or ASC 718, which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors based on estimated fair values on the grant date. We adopted ASC 718 on January 1, 2006 using the modified prospective method. We estimate the fair value of stock-based awards on the date of grant using the Black-Scholes-Merton (Black-Scholes) option-pricing model. These standards require us to expense employee stock options and other share-based payments. The Company recognizes as expense the fair value of employee and non-employee stock option grants. These expenses amounted to approximately $160,000 and $178,000 for the years ended December 31, 2016 and 2015, respectively.

 

Valuation of Long-lived Assets

 

The Company’s long-lived assets consist of property and equipment and intangible assets. Equipment is carried at cost and is depreciated over the estimated useful lives of the assets, which are generally two to three years, and leasehold improvements are amortized over the lesser of the lease term or the estimated useful lives of the improvements. The straight-line method is used for depreciation and amortization. Intangible assets consist of patents, which are amortized using the straight-line method over the estimated useful lives of the patents. The Company does not capitalize external legal costs and filing fees associated with obtaining patents on its new discoveries. Acquired intellectual property is recorded at cost and is amortized over its estimated useful life. The Company believes the useful lives assigned to these assets are reasonable. The Company assesses the recoverability of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in management’s estimate of future cash flows to determine recoverability of these assets. If management’s assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss.

 

Convertible Debentures and Warrants

 

For Convertible Debentures issued previous to March 31, 2013 containing exchange features, we account for the Convertible Debentures, associated warrants and conversion features under the provisions of FASB Topic 815, Debt, or ASC 815 which requires the measurement and recognition of the fair values for all components related to the Convertible Debentures at the end of each reporting period. We estimate the fair value of the contingent beneficial conversion option, holders’ warrants and agent warrants at each measurement date using a combination of the Black-Scholes-Merton and modified Binomial Lattice option-pricing models. These standards require us to record the fair value of the Convertible Debentures and warrants at the time of issuance and to remeasure these values and record associated income statement expense or benefit at each reporting period. A more detailed description can be found in Note 8 of the enclosed financial statements. For Convertible Debentures issued subsequent to March 31, 2013 which did not contain exchange features, we account for the Convertible Debentures, associated warrants and conversion features under the provisions of ASC 470 which requires the valuation of the debt discount to be recognized on the date of issuance and the amount of debt discount to be amortized over the life of the Convertible Debenture.

 

27  
 

 

Variable Conversion Rate Debentures

 

Starting in 2015, the Company entered into convertible debentures with floating exercise prices discounted to market prices. As a result, a significant number of shares were either issued in 2015 and 2016 or will be issued in subsequent periods at deeply discounted variable conversion prices. The downward pressure placed on the Company’s stock as a result of these conversions can be classified as “death spirals” since the investors have no incentive to maintain a stable stock price. The Company accounts for these debentures as derivative liabilities which means the debentures are revalued at the end of each period and gains and losses are recognized at the issuance of the debentures and on the conversion of the debentures.

 

Over Commitment of Shares

 

Since the number of shares issuable under convertible debentures with floating exercise prices is undeterminable, the Company may be required to issue shares in excess of the number of shares authorized by its shareholders. As a result, when the Company determines that is does not have sufficient shares to meet the obligations of derivative unexercised debentures, warrants and options, the derivatives must be valued using the Black Scholes Option Pricing method and a liability is recorded as though the obligations would be settled using some means other than stock.

 

RECENT ACCOUNTING PRONOUNCEMENTS: None

 

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not required.

 

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

 

Consolidated audited financial statements for the years ended December 31, 2016 and 2015 are filed as part of this Form 10-K.

 

SpectraScience, Inc. and Subsidiaries

Consolidated Financial Statements

Years Ended December 31, 2016 and 2015

 

    Page
Report of Independent Registered Public Accounting Firm   29
   
Consolidated Balance Sheets as of December 31, 2016 and 2015   30
     
Consolidated Statements of Operations for the years ended December 31, 2016 and 2015   31
     
Consolidated Statements of Shareholders’ Deficit for the years ended December 31, 2016 and 2015   32
     
Consolidated Statements of Cash Flows for the years ended December 31, 2016 and 2015   33
     
Notes to Consolidated Financial Statements   34

 

28  
 

 

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Shareholders

SpectraScience, Inc. and Subsidiaries

 

We have audited the accompanying consolidated balance sheets of SpectraScience, Inc., and Subsidiaries as of December 31, 2016 and 2015, and the related consolidated statements of operations, shareholders’ deficit, and cash flow for the years ended December 31, 2016 and 2015. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of SpectraScience, Inc. and Subsidiaries as of December 31, 2016 and 2015 and the results of their operations and their cash flows for the two years then ended in conformity with U.S. generally accepted accounting principles.

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has suffered recurring losses from operations and its ability to continue as a going concern is dependent on the Company’s ability to attract investors and generate cash through issuance of equity instruments and convertible debt. This raises substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ Haynie & Company  
   
Haynie & Company  
Salt Lake City, Utah  
March 31, 2017  

 

29  
 

 

SpectraScience, Inc. and Subsidiaries

Consolidated Balance Sheets

 

    December 31, 2016     December 31, 2015  
             
ASSETS                
Current assets:                
Cash   $ 3,550     $ 127,493  
Accounts receivable, net     950       7,061  
Inventory, current portion     90,594       111,887  
Prepaid expenses and other current assets     266,749       284,305  
Total current assets     361,843       530,746  
                 
Fixed assets, net     -       316  
Long-term inventory     -       150,000  
Patents, net     1,024,524       1,185,472  
    $ 1,386,367     $ 1,866,534  
                 
LIABILITIES AND SHAREHOLDERS' DEFICIT                
Current liabilities:                
Accounts payable   $ 1,318,737     $ 941,106  
Accrued Expenses     2,278,042       1,411,333  
Notes payable- related parties     35,000       -  
Note payable     137,982       137,982  
Convertible debt, net of discounts of $203,444 as of December 31, 2016 and $349,729 as of December 31, 2015.     6,211,861       5,744,604  
Derivative liability     819,928       620,321  
Total current liabilities     10,801,550       8,855,346  
                 
Long-term secured convertible debt     1,100,000       -  
                 
COMMITMENTS AND CONTINGENCIES                
                 
Mezzanine equity                
Series B Convertible Preferred Stock, $.01 par value; 2,585,000 shares authorized, issued and outstanding as of December 31, 2016 and December 31, 2015; liquidation value of $517,000 plus accumulated and and unpaid dividends of $106,931 as of December 31, 2016 and December 31, 2015     25,850       25,850  
Series C Convertible Preferred Stock, $.01 par value; 500,000 shares authorized, issued and outstanding as of December 31, 2016 and December 31, 2015; liquidation value of $100,000 as of December 31, 2016 and December 31, 2015     5,000       5,000  
Total mezzanine equity     30,850       30,850  
                 
Shareholders' deficit Series A Convertible Preferred Stock, $.01 par value; 0 shares authorized, issued and outstanding as of December 31, 2016 and December 31, 2015     -       -  
Series AA Super Voting Preferred Stock, $.001 par value; 3,000 and 0 shares authorized, issued and outstanding as of December 31, 2016 and December 31, 2015     3       -  
Common stock, $.01 par value; 1,996,000,000 shares authorized; 883,671,222 and 431,247,207 shares issued and outstanding as of December 31, 2016 and December 31, 2015     8,836,712       4,312,472  
Additional paid in capital     34,582,771       38,166,818  
Accumulated deficit     (53,965,519 )     (49,498,952 )
Total shareholders' deficit     (10,546,033 )     (7,019,662 )
    $ 1,386,367     $ 1,866,534  

 

See accompanying report of independent registered public accounting firm, summary of accounting polices and notes to consolidated financial statements.

 

30  
 

 

SpectraScience, Inc. and Subsidiaries

Consolidated Statements of Operations

 

    Year Ended  
    December 31,  
    2016     2015  
             
Revenue   $ 5,150     $ 6,600  
Cost of revenue     199,405     $ 602  
Gross profit (loss)     (194,255 )     5,998  
                 
Operating expenses:                
Research and development     636,622       719,210  
General and administrative     1,244,954       1,475,809  
Sales and marketing     368,355       294,353  
      2,249,931       2,489,372  
                 
Loss from operations     (2,444,186 )     (2,483,374 )
                 
Other income (expense)                
Interest expense     (963,549 )     (667,892 )
Change in fair value of derivative and warrant liabilities     (696,080 )     1,174,444  
Amortization of derivative and warrant liabilities discount     (437,868 )     (904,305 )
Amortization of deferred debt issuance costs and original issue discount     (191,366 )     (353,985 )
Gain on extinguishment of debt     469,659       260,564  
Loss on issuance of variable rate debt     (224,618 )     (651,691 )
Gain on foreign exchange transactions     22,212       4,385  
Other expense, net     (770 )     (13,014 )
      (2,022,381 )     (1,151,494 )
                 
Net loss   $ (4,466,567 )   $ (3,634,868 )
                 
Basic and diluted loss per share   $ (0.01 )   $ (0.02 )
                 
Weighted average common shares outstanding     697,694,480       216,335,085  

 

See accompanying report of independent registered public accounting firm, summary of accounting polices and notes to consolidated financial statements.

 

31  
 

 

SpectraScience, Inc. and Subsidiaries

Consolidated Statements of Shareholders' Deficit

For Years Ended December 31, 2016 and 2015

 

    Series AA Super Voting Preferred     Common Stock    

Additional

Paid-In

    Accumulated    

Total

Shareholders'

 
    Shares     Amount     Shares     Amount     Capital     Deficit     Deficit  
                                           
Balance December 31, 2014     -     $ -       194,355,277     $ 1,943,553     $ 39,509,115     $ (45,864,084 )   $ (4,411,416 )
                                                         
Non cash issuance of stock options     -       -       -       -       177,523       -       177,523  
Common stock issued for cash on option exercise     -       -       200,000       2,000       -       -       2,000  
Conversion of convertible debt     -       -       236,691,930       2,366,919       (1,576,336 )     -       790,583  
Warrant valuation on issuance with convertible debt     -       -       -       -       118,096       -       118,096  
Warramt value reclassed to derivative liability for lack of shares     -       -       -       -       (64,428 )     -       (64,428 )
Non cash issuance of warrant for consulting services     -       -       -       -       2,848       -       2,848  
Net loss     -       -       -       -       -       (3,634,868 )     (3,634,868 )
                                                         
Balance December 31, 2015     -       -       431,247,207       4,312,472       38,166,818       (49,498,952 )     (7,019,662 )
                                                         
Non cash issuance of stock options     -       -       -       -       160,004       -       160,004  
Conversion of convertible debt     -       -       452,424,015       4,524,240       (3,747,594 )     -       776,646  
Issuance of Series AA Super Voting Preferred Stock     3,000       3       -       -       24,997       -       25,000  
Special dividend related to Series AA Super Voting Preferred Stock     -       -       -       -       (25,000 )     -       (25,000 )
Non cash issuance of warrant for consulting services     -       -       -       -       3,546       -       3,546  
Net loss     -       -       -       -       -       (4,466,567 )     (4,466,567 )
                                                         
Balance December 31, 2016     3,000     $ 3       883,671,222     $ 8,836,712     $ 34,582,771     $ (53,965,519 )   $ (10,546,033 )

 

See accompanying report of independent registered public accounting firm, summary of accounting policies and notes to consolidated financial statements.

 

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SpectraScience, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

 

    December 31,  
    2016     2015  
Operating activities:                
Net loss   $ (4,466,567 )   $ (3,634,868 )
Adjustments to reconcile net loss to cash used in operating activities:                
Obsolete inventory reserve     196,437       -  
Amortization and depreciation     161,263       165,772  
Non-cash issuance of stock options     160,004       177,523  
Non-cash issuance of warrants     3,546       2,848  
Non -cash interest on forbearance agreements     65,282       -  
Common stock issued for services     1,200       -  
Debt issued for servces     15,000       -  
Non -cash interest on lack of shares     (5,972 )     -  
Amortization of derivative and warrant liabilities discount     437,868       904,305  
Amortization of deferred debt issuance costs and original issue discount     191,366       353,985  
Change in fair value of derivative and warrant liabilities     696,080       (1,174,444 )
Gain on extinguishment of debt     (469,659 )     (260,564 )
Loss on issuance of variable rate debt     224,618       651,691  
Changes in assets and liabilities:                
Accounts receivable     6,111       (7,061 )
Inventories     (25,145 )     21,738  
Prepaid expense and other assets     17,556       (40,132 )
Accounts payable     377,635       104,968  
Accrued expenses     900,646       844,453  
Net cash used in operating activities     (1,512,731 )     (1,889,786 )
                 
Investing activities:                
Net cash used in investing activities     -       -  
                 
Financing activities:                
Proceeds from issuance of convertible notes payable     1,420,000       1,970,250  
Proceeds from issuance of note payable     -       50,000  
Proceeds from issuance of note payable to affiliate     35,000       -  
Payment against note payable     -       (50,000 )
Proceeds from exercise of stock options     -       2,000  
Debt issuance costs     (66,212 )     (178,500 )
Net cash provided by financing activities     1,388,788       1,793,750  
                 
Net decrease in cash     (123,943 )     (96,036 )
                 
Cash, beginning of year     127,493       223,529  
                 
Cash, end of year   $ 3,550     $ 127,493  
                 
Supplemental Disclosure of Cash Flow Information:                
Cash paid during the period for:                
Interest   $ -     $ 18,000  
Income taxes   $ -     $ -  
Non Cash Investing and Financing Activities:                
Conversion of convertible notes to common stock   $ 169,486     $ 437,355  
Conversion of interest due on convertible notes to common stock   $ 24,188     $ 68,150  
Reduction of derivative liability on conversion of convertible notes   $ 1,232,152     $ 637,874  
Reduction of debt discount on conversion of convertible notes   $ (167,217 )   $ (84,192 )
Reduction of debt issuance costs on conversion of convertible notes   $ (13,504 )   $ (8,041 )
Conversion of interest payable to increase in note   $ 9,749     $ 37,982  
Valuation of Series AA Super Voting Preferred Stock   $ 25,000       -  
Warrant valuation on issuance with convertible debt   $ -     $ 118,096  
Derivative liability recorded as debt discount   $ -     $ 654,682  
Reclass of warrant value to derivative liability for lack of shares   $ -     $ (64,428 )

 

See accompanying report of independent registered public accounting firm, summary of accounting polices and notes to consolidated financial statements.

 

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SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

 

Note 1: Organization and Description of Business

 

SpectraScience, Inc. was incorporated in the State of Minnesota on May 4, 1983 as GV Medical, Inc. In October 1992, GV Medical discontinued its prior business, refocused its development efforts and changed its name to SpectraScience, Inc. The “Company,” hereinafter, refers to SpectraScience, Inc. and its wholly owned subsidiaries Luma Imaging Corp., SpectraScience International, Inc. and SpectraScience (UK) Ltd. From 1996, the Company primarily focused on developing the WavSTAT Optical Biopsy System (the “WavSTAT System”).

 

The Company has developed and received the European CE mark approval to market a proprietary, minimally invasive technology that optically illuminates tissue in real-time to distinguish between normal, pre-cancerous or cancerous cells without the need to remove the subject cell tissue from the body to make such determinations. The WavSTAT System operates by using cool, safe laser light to optically illuminate and analyze tissue, enabling the physician to make an instant diagnosis during endoscopy when screening for cancer, and if warranted, to begin immediate treatment during the same procedure. Beginning in December 2011, the WavSTAT 4 version of the product began to be sold in the European Union for colon cancer detection. In June 2012 the Company entered into a distribution agreement with PENTAX Europe, GmbH, for the sale of its systems internationally.

 

On November 6, 2007, the Company acquired the assets of Luma Imaging Corporation (“LUMA”) in an equity transaction accounted for as an acquisition of assets and now operates LUMA as a wholly-owned subsidiary of the Company. LUMA had acquired the assets from a predecessor company that had developed, and received FDA approval for, a minimally-invasive diagnostic imaging system that can detect cervical cancer precursors and which utilizes an underlying technology that is similar to that of the WavSTAT System. The addition of the LUMA technology to the Company’s existing WavSTAT System technology provides the Company with a broad suite of fluorescence-based intellectual property and know-how. During the fiscal year ended December 31, 2010, the Company wrote off the remaining fair value of the LUMA inventory in order to focus on the continued development and marketing of the WavSTAT System. The Company retained the intellectual property of LUMA for use in the development of future generations of the WavSTAT System. The intellectual property consisted of a total of 34 issued U.S. Patents and 28 additional patent applications.

 

Note 2: Going Concern

 

Historically, the Company’s sources of cash have come from the issuance and sales of equity securities and convertible debentures. The Company’s historical cash outflows have been primarily used for operating activities including research, development, administrative and sales activities. Fluctuations in the Company’s working capital due to timing differences of its cash receipts and cash disbursements also impact its cash flow. The Company expects to incur significant additional operating losses through at least the end of 2017, as it completes proof-of-concept trials, conducts outcome-based clinical studies and increases sales and marketing efforts to commercialize the WavSTAT4 System in Europe. The Company may incur unknown expenses or may not be able to meet its revenue forecast, and one or more of these circumstances would require the Company to seek additional capital. The Company may not be able to obtain equity capital or debt funding on terms that are acceptable. Even if the Company receives additional funding, such proceeds may not be sufficient to allow the Company to sustain operations until it becomes profitable and begins to generate positive cash flows from operations. This raises substantial doubt about the Company’s ability to continue as a going concern.

 

As of December 31, 2016, the Company had a working capital deficit of $10,439,697 and cash of $3,550, compared to a working capital deficit of $8,324,600 and cash of $127,493 as of December 31, 2015.

 

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SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

For the year ended December 31, 2016, the Company raised approximately $1,455,000 under various funding agreements. However, if the Company does not receive additional funds in a timely manner, the Company could be in jeopardy as a going concern. The Company may not be able to find alternative capital or raise capital or debt on terms that are acceptable. Management believes that if the events defined in the various funding agreements occur as expected, such proceeds will be sufficient to allow the Company to sustain operations until it attains profitability and positive cash flows from operations. However, the Company may incur unknown expenses or may not be able to meet its revenue expectations requiring it to seek additional capital. In such event, the Company may not be able to find capital or raise capital or debt on terms that are acceptable.

 

The holders of Convertible Debentures control the conversion of the Convertible Debentures and certain of the Convertible Debentures were not converted at their maturity constituting a potential default on the matured, but unconverted, Convertible Debentures. In the event of such default, principal, accrued interest and other related costs are immediately due and payable in cash. As of December 31, 2016, Convertible Debentures with a face value of $5,849,552 held by 78 individual investors are in default. None of these investors have served notice of default on the Convertible Debentures held by them.

 

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

Note 3: Summary of Significant Accounting Policies

 

Consolidation

 

The accompanying consolidated financial statements include the accounts of SpectraScience, Inc. and its wholly-owned subsidiaries Luma Imaging Corp., SpectraScience International, Inc. and SpectraScience (UK) Ltd. All significant intercompany balances and transactions have been eliminated in consolidation.

 

Reclassifications

 

Certain reclassifications have been made to the 2015 financial statements in order for them to conform to the 2016 presentation. Such reclassifications have no impact on the Company’s financial position or results of operations.

 

Use of Estimates

 

The Company prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, which requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Significant estimates made by management include, among others, realization of long-lived assets including intangible assets, assumptions used to value stock options, assumptions used to value the common stock issued and assumptions related to the determination of the fair value of the derivative components associated with the Company’s convertible debentures. Actual results could differ from those estimates.

 

 

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SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Accounts Receivable

 

Receivables are carried at original invoice amount less payment received and an estimate is made for doubtful receivables based on a review of all outstanding amounts on a monthly basis. Receivables are generally considered past due 30 days after the payment date as specified on the invoice. We determine the allowance for doubtful accounts by regularly evaluating individual receivables and considering a creditor’s financial condition, credit history and current economic conditions. Receivables are written off when deemed uncollectible. Recoveries of previously written off receivables previously written off are recorded when received.

 

Inventory

 

We state our inventory at the lower of cost (using the first-in, first-out method) or market value, determined on an average cost basis. We provide inventory allowances when conditions indicate that the selling price could be less than cost due to obsolescence and reductions in estimated future demand. We balance the need to maintain strategic inventory levels with the risk of obsolescence due to changing technology and customer demand levels. Unfavorable changes in market conditions may result in a need for inventory reserves that could adversely impact our gross margins. Conversely, favorable changes in demand could result in higher gross margins when we sell products.

 

During the year ended December 31, 2014, the Company concentrated on clinical trials in Europe to validate the accuracy and cost effectiveness of the WavSTAT system. In anticipation of purchase orders on the completion of the trials, the Company had purchased inventory for approximately 30 consoles which will be used to fulfill initial orders expected from the United Kingdom and Germany. Due to the delayed commercialization of the WavSTAT, the Company established an inventory obsolescence reserve as of December 31, 2016.

 

Property and Equipment

 

The Company’s long-lived assets consist of property and equipment and intangible assets. Equipment is carried at cost and is depreciated over the estimated useful lives of the assets, which are generally two to three years, and leasehold improvements are amortized over the lesser of the lease term or the estimated useful lives of the improvements. The straight-line method is used for depreciation and amortization. Intangible assets consist of patents, which are amortized using the straight-line method over the estimated useful lives of the patents. The Company does not capitalize external legal costs and filing fees associated with obtaining patents on its new discoveries. Acquired intellectual property is recorded at cost and is amortized over its estimated useful life. The Company believes the useful lives assigned to these assets are reasonable. The Company assesses the recoverability of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in management’s estimate of future cash flows to determine recoverability of these assets. If management’s assumptions about these assets were to change as a result of events or circumstances, the Company may be required to record an impairment loss.

 

Patents

 

The Company accounts for acquired intangible assets under FASB ASC Topic 350 Goodwill and Other Intangibles –General Intangibles Other than Goodwill . All patents are amortized over the shorter of their remaining legal lives or estimated economic lives. When acquired, the WavSTAT System patents had an average remaining useful life of 13 years, while the LUMA patents had an average remaining life of approximately 15 years.

 

Convertible Debentures/Warrants

 

For Convertible Debentures issued previous to March 31, 2013 containing exchange features, we account for the Convertible Debentures, associated warrants and conversion features under the provisions of FASB Topic 815, Debt, or ASC 815, which requires the measurement and recognition of the fair values for all components related to the Convertible Debentures at the end of each reporting period. We estimate the fair value of the contingent beneficial conversion option, holders’ warrants and agent warrants at each measurement date using a combination of the Black-Scholes-Merton and modified Binomial Lattice option-pricing models. These standards require us to record the fair value of the Convertible Debentures and warrants at the time of issuance and to remeasure these values and record associated income statement expense or benefit at each reporting period. A more detailed description can be found in Note 8 to the financial statements. For Convertible Debentures issued subsequent to March 31, 2013 which did not contain exchange features, we account for the Convertible Debentures, associated warrants and conversion features under the provisions of ASC 470 which requires the valuation of the debt discount to be recognized on the date of issuance and the amount of debt discount to be amortized over the life of the Convertible Debenture.

 

36  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Variable Conversion Rate Debentures

 

Starting in 2015, the Company entered into convertible debentures with floating exercise prices discounted to market prices. As a result, a significant number of shares were either issued in 2015, 2016 or will be issued in subsequent periods at deeply discounted variable conversion prices. The downward pressure placed on the Company’s stock as a result of these conversions can be classified as “death spirals” since the investors have no incentive to maintain a stable stock price. The Company accounts for these debentures as derivative liabilities which means the debentures are revalued at the end of each period and gains and losses are recognized at the issuance of the debentures and on the conversion of the debentures.

 

Over Commitment of Shares

 

Since the number of shares issuable under convertible debentures with floating exercise prices are undeterminable, the Company may be required to issue shares in excess of the number of shares authorized by its shareholders. As a result, when the Company determines that is does not have sufficient shares to meet the obligations of derivative unexercised debentures, warrants and options, the derivatives must be valued using the Black Scholes Option Pricing method and a liability is recorded as though the obligations would be settled using some means other than stock.

 

Stock-Based Compensation

 

The Company accounts for stock-based compensation under the provisions of FASB ASC Topic 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using the Black-Scholes-Merton option-pricing model (the “Black-Scholes Model”). The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods using the straight-line method.

 

The Company estimates forfeitures at the time of grant and revises its estimate in subsequent periods if actual forfeitures differ from those estimates.

 

The Company accounts for stock-based compensation awards to non-employees in accordance with FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees (“ASC 505-50”). Under ASC 505-50, the Company determines the fair value of the warrants or stock-based compensation awards granted as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable.

 

All issuances of stock options or other equity instruments to employees and non-employees as the consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. Any stock options issued to non-employees are recorded in expense and additional paid-in capital in shareholders’ equity over the applicable service periods using variable accounting through the vesting dates based on the fair value of the options at the end of each reporting period.

 

37  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Revenue Recognition

 

The Company recognizes revenues when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. Revenue from the sale of the Company’s products is generally recognized when title and risk of loss transfers to the customer, the terms of which are generally free-on-board shipping point. The Company uses customer purchase orders to determine the existence of an arrangement. The Company uses shipping documents and third-party proof of delivery to verify that title has transferred. The Company assesses whether the fee is fixed or determinable based upon the terms of the agreement associated with the transaction. To determine whether collection is probable, the Company assesses a number of factors, including past transaction history with the customer and the creditworthiness of the customer.

 

Research and Development

 

Research and development costs are expensed as incurred. There may be cases in the future where certain research and development costs such as software development costs are capitalized. For the years ended December 31, 2016 and 2015, research and development costs were approximately $637,000 and $719,000, respectively.

 

Fair Value of Financial Instruments

 

The carrying amount of the Company's cash, accounts receivable, accounts payable and accrued liabilities approximate their estimated fair values due to the short-term maturities of those financial instruments.

 

Income Taxes

 

Income taxes are provided for the tax effects of transactions reported in the consolidated financial statements and consist of taxes currently due plus deferred income taxes. Deferred income taxes are recognized for temporary differences between the financial statement and tax basis of assets and liabilities that will result in taxable or deductible amounts in the future. Deferred income taxes are also recognized for net operating loss carryforwards that are available to offset future taxable income and research and development credits. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

 

FASB Accounting Standards Codification Topic 740, Income Taxes (“ASC 740”), clarifies the accounting for uncertainty in income taxes recognized in the financial statements. ASC 740 provides that a tax benefit from an uncertain tax position may be recognized when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits of the position. Income tax positions must meet a more-likely-than-not recognition threshold to be recognized. ASC 740 also provides guidance on measurement, derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. We have determined that the Company does not have uncertain tax positions on its tax returns for the years 2016 and prior. Based on evaluation of the 2016 transactions and events, the Company does not have any material uncertain tax positions that require measurement. Because the Company had a full valuation allowance on its deferred tax assets as of December 31, 2016 and 2015, the Company has not recognized any tax benefits since inception.

 

Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense. We had no accrual for interest or penalties on our consolidated balance sheets at December 31, 2016 or 2015, and have not recognized interest and/or penalties in the consolidated statement of operations for the years ended December 31, 2016 or 2015.

 

We are subject to taxation in the U.S. and the state of California. All of our tax years are subject to examination by the U.S. and California tax authorities due to the carry-forward of unutilized net operating losses.

 

38  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Earnings (Loss) Per Share

 

Basic earnings (loss) per share is computed by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the period of computation. Diluted earnings (loss) per share is computed similarly to basic earnings per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and only if the additional common shares would be dilutive. (See Note 13)

 

Note 4: Accounts Receivables

 

Accounts receivables are carried at the expected realizable value and consisted of the following at December 31, 2016 and 2015:

 

    December 31,  
    2016     2015  
             
Accounts receivable - trade   $ 950     $ 7,061  
Allowance for doubtful accounts     -       -  
                 
Accounts receivable, net   $ 950     $ 7,061  

 

During the year ended December 31, 2016, we had two significant customers who accounted for 82% and 18% of sales. During the year ended December 31, 2015, we had one significant customer who accounted for 100% of sales.

 

At December 31, 2016, we had one significant customer who accounted for 100% of our accounts receivable. At December 31, 2015, we had one different significant customer who accounted for 100% of our accounts receivable.

 

Note 5: Inventory

 

Inventory is carried at the lower of average cost or market and consisted of the following at December 31, 2016 and 2015:

 

    December 31,  
    2016     2015  
             
Raw materials   $ 256,163     $ 216,704  
Finished goods     30,868       45,183  
      287,031       261,887  
Reserve for obsolescence     (196,437 )     -  
      90,594       261,887  
Less long-term portion     -       150,000  
    $ 90,594     $ 111,887  

 

39  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Note 6: Property and Equipment

 

The following is a summary of equipment, at cost, less accumulated depreciation at December 31, 2016 and 2015:

 

    December 31,  
    2016     2015  
             
Computers and office fixtures   $ 50,342     $ 50,342  
Machinery and equipment     428,650       428,650  
      478,992       478,992  
                 
Less accumulated depreciation     478,992       478,676  
                 
    $ -     $ 316  

 

Depreciation expense for the years ended December 31, 2016 and 2015 was $316 and $3,350, respectively. Repairs and maintenance are charged to expense as incurred while improvements are capitalized. Upon the sale, retirement or disposal of fixed assets, the accounts are relieved of the cost and the related accumulated depreciation with any gain or loss recorded to the consolidated statements of operations.

 

Note 7: Patents

 

The following is a summary of patents less accumulated amortization at December 31, 2016 and 2015:

 

    December 31,  
    2016     2015  
             
Patents   $ 2,980,033     $ 2,980,033  
                 
Less accumulated amortization     1,955,509       1,794,561  
                 
    $ 1,024,524     $ 1,185,472  

 

Amortization expense associated with patents for the years ended December 31, 2016 and 2015 was $160,948 and $162,422, respectively. The estimated future amortization expense related to patents as of December 31, 2016 is as follows:

 

Year Ended December 31.   Amount  
       
2017   $ 159,347  
2018     148,649  
2019     135,775  
2020     132,962  
2021     119,845  
Thereafter     327,946  
Total   $ 1,024,524  

 

40  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Note 8: Liabilities

 

Note Payable

 

In November 2014, the Company issued for cash of $100,000 an unsecured note payable and a five year warrant with an exercise price of $0.09 per share for the purchase of up to 50,000 shares of common stock. The terms of the note were a repayment of $115,000 if paid by February 18, 2015 and, if paid thereafter, the principal balance of the note was to be increased to $137,982 as of October 1, 2015 and interest will accrue at 20% from October 1, 2015 until paid. The note remained outstanding at December 31, 2016 and is accruing interest at 20%. The warrant was valued at $1,659 using the Black-Scholes Pricing Model and was recorded as additional paid-in capital and expensed to non-cash interest in 2014.

 

On August 12, 2015, the Company issued for cash of $50,000 an unsecured note payable. The terms of the note were a repayment of $53,000 if paid by August 31, 2015 and $58,000 if paid between September 1 and September 30, 2015. The note was repaid in September 2015 in the amount of $58,000.

 

Notes Payable- Related Parties

 

During the year ended December 31, 2016, two affiliates of the Company advanced to the Company cash in an accumulated amount of $35,000 in exchange for six-month 10% promissory notes. The balance of the notes remains $35,000 at December 31, 2016.

 

Secured Convertible Note

 

During the year ended December 31, 2016, the Company issued for cash of $1,100,000 Secured Convertible Debentures (the “Debentures”) to two accredited investors. The terms of the Debentures are for three years, a conversion price of $0.01 per share and an annual interest rate of 8%. The secured interest is on all of the assets of the Company. The entire amount of the issuance remains outstanding as of December 31, 2016.

 

Convertible Debt

 

As of December 31, 2016, the Company has issued and outstanding Convertible Debentures (“Debentures”) with original terms of six months to one year, an interest rate ranging from 10-20% per year and an original issue discount ranging from 5% to 10% which, at the option of the holder, may convert into common stock at an initial conversion price ranging from $0.01 to $0.099 per share. The Debentures were issued with detachable five year cashless Holders Warrants that allow the holders to purchase one share of stock for each two shares available under the converted Debentures at an exercise price ranging from $0.02 to $0.1287 per share. In addition, the Company issued five-year cashless Agent Warrants equal to 10% of the total number of shares issuable under the Debentures and Holders Warrants at an exercise price ranging from $0.0745 to $0.1287 per share. For debentures issued through March 31, 2013, at the option of the Debenture holder, the terms of the Debentures and Holders Warrants are subject to an exchange feature in the event that the Company issues securities with terms more favorable than those of the then outstanding Debentures and Holders Warrants. Debentures issued subsequent to March 31, 2013 do not contain such an exchange clause. The gross amount of Debentures outstanding is $6,127,082 as of December 31, 2016.

 

41  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

As of December 31, 2016, the Company has issued and outstanding Convertible Debentures (“Variable Debentures”) with original terms of 9 months to one year, an interest rate ranging from 0-10% per year and original issue discount rate ranging from 0-10% which contain variable conversion rates ranging from discounts of 40-50% of the Company’s common stock based on the lowest trading prices ranging from 10-25 days previous to conversion. The Variable Debentures contain prepayment options which enable the Company to prepay the notes for periods of 0-180 days subsequent to issuance at premiums ranging from 0-50%. The gross amount of Variable Debentures outstanding is $288,223 as of December 31, 2016.

 

As of December 31, 2016 and 2015, the balances of the Debentures are as follows:

 

    December 31,2016     December 31,2015  
             
Balance at beginning of period   $ 6,174,760     $ 4,496,602  
Issuance of debentures for cash     320,000       1,970,250  
Issuance of debentures for services     15,000       -  
Original issue discount     -       145,263  
Issuance of debentures for forbearance     65,282       -  
Debentures converted to common stock     (291,754 )     (437,355 )
Debentures exchanged for new debentures     132,017       -  
Convertible debt     6,415,305       6,174,760  
Less unamortized costs of financing     203,444       430,156  
Convertible debt, net of unamortized costs   $ 6,211,861     $ 5,744,604  
                 
Convertible debt in default   $ 5,991,570     $ 4,313,199  

 

Future minimum payments on the notes payable, secured convertible debt and convertible debt are as follows:

 

Twelve months ending,      
December 31, 2017   $ 6,588,287  
December 31, 2018     -  
December 31, 2019     1,100,000  
Thereafter     -  
    $ 7,688,287  

 

Derivative Liability

 

Since the Company issued Convertible Debentures which included Holders Warrants and a conversion option that includes a possible exchange feature in the event of a future financing on terms more favorable than those of the existing warrants and debentures and Variable Debentures which include conversion rights which vary with the price of the Company’s stock, this results in the warrants and conversion feature of the debentures being recorded as a liability and measured at fair value. The Company measures these warrants and conversion feature using the Black-Scholes option valuation model using similar assumptions to those described under “Stock-Based Compensation.” The time period over which the Company will be required to evaluate the fair value of the warrants is approximately five years and the time period over which the Company will be required to evaluate the fair value of the conversion feature is the lesser of six to twelve months or conversion.

 

42  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

The assumptions used in determining fair value represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if factors change, including changes in the market value of the Company’s common stock, managements’ assessment of the probability of a more favorably priced future financing or significant fluctuations in the volatility of the trading market for the Company’s common stock, the Company’s fair value estimates could be materially different in the future.

 

The Company computes the fair value of the derivative liability at each reporting period and the change in the fair value is recorded as non-cash expense or non-cash income. The key component in the value of the derivative liability is the Company’s stock price, which is subject to significant fluctuation and is not under the Company’s control. The resulting effect on net loss is therefore subject to significant fluctuation and will continue to be so until the Company’s Debentures, to which the convertible feature is associated, are converted into common stock or paid in full. Assuming all other fair value inputs remain constant, the Company will record non-cash expense when its stock price increases and non-cash income when its stock price decreases.

 

In addition, since the number of shares issuable under the Variable Debentures are undeterminable, the Company may be required to issue shares in excess of the number of shares authorized by its shareholders. As a result, when the Company determines that is does not have sufficient shares to meet the obligations of derivative unexercised debentures, warrants and options, the derivatives must be valued using the Black Sholes Option Pricing method and a liability is recorded as though the obligations would be settled using some means other than stock. For the years ended December 31, 2016 and 2015, the Company determined that it was over committed to the number of shares issuable on the exercise of outstanding debentures, stock options and warrants for approximately 358,000,000 and 386,000,000 shares, respectively.

 

As of December 31, 2016 and 2015, the balances of the Derivative Liability are as follows:

 

                Commitment        
    Warrant     Derivative     In Excess of     Total  
    Liability     Liability     Authorized Stock     Liability  
Balance December 31, 2014   $ 764,958     $ 296,881     $ -     $ 1,061,839  
                                 
Liability on issuance of debt and warrants     -       1,306,372       -       1,306,372  
                                 
Elimination of liability on conversion     -       (637,874 )     -       (637,874 )
                                 
Change in estimated fair value (1)     (704,538 )     (469,906 )     -       (1,174,444 )
                                 
Over commitment of stock     -       -       64,428       64,428  
                                 
Balance December 31, 2015   $ 60,420     $ 495,473     $ 64,428     $ 620,321  
                                 
Liability on issuance of debt and warrants     44,394       697,256       -       741,650  
                                 
Elimination of liability on conversion     -       (1,232,151 )     -       (1,232,151 )
                                 
Change in estimated fair value (1)     (22,378 )     718,458       -       696,080  
                                 
Overcommitment of stock     -       -       (5,972 )     (5,972 )
                                 
Balance December 31, 2016   $ 82,436     $ 679,036     $ 58,456     $ 819,928  

 

Debentures issued subsequent to March 31, 2013 did not contain an exchange provision and were accounted for using the equity method of valuing the note and warrant. For the years ended December 31, 2016 and 2015, $0 and $118,096 were recorded as additional paid-in capital related to the initial valuation of debt discounts and warrants associated with new debentures entered into subsequent to March 3l, 2013.

 

Management used the following inputs to value the Derivative and Warrant Liabilities for the year ended December 31, 2016:

 

43  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

    12/31/2016       12/31/2015    
    Derivative Liability   Warrant Liability   Derivative Liability   Warrant Liability
Expected term   6 months to 2 years   5 years   6 months - 1 year   5 years
Exercise price   $0.00025 - $0.099   $0.02 - $0.1287   $0.0005 - $0.099   $0.075 - $0.1287
Expected volatility   217% to 334%   242% to 283%   286% to 448%   210% to 277%
Expected dividends   None   None   None   None
Risk-free interest rate   0.37% to 1.05%   1.14% to 1.93%   0.26% to 0.65%   1.32% to 1.76%
Forfeitures   None   None   None   None

 

In computing the fair value of the derivative and warrant liability at December 31, 2016 and 2015 for instruments under the Black Sholes option-pricing model, management estimated a 60% probability of a down round financing event at a price of $0.025 and an 15% to 56% probability that existing note holders with exchange privileges would exchange their existing debentures and warrants for new debentures and warrants.

 

Legal Proceedings

 

On July 7, 2016, Oakmore Opportunity Fund I LP, a variable rate noteholder of spectraScience, filed for a preliminary judgement of $116,500 in the Superior Court for the Country of Los Angles, case number BC622542, related to a Convertible Note. Oakmore asserts that SpectraScience breached the terms of the Convertible Note due to having sufficient authorized shares to enable Oakmore to convert its Note with a balance of $22,500. The Company did not object to the preliminary judgement. On October 19, 2016, the Judge issued a final judgement of $521,100. The Company is retaining litigation counsel and intends to vigorously defend the amount of the judgement. The amount of ultimate liability with respect to the foregoing cannot be determined, however, the Company has established a $150,000 contingency to cover the costs of litigation and the judgement. Despite the inherent uncertainties of litigation, the Company at this time does not believe that Oakmore’s claim will have a material adverse impact on its financial condition, results of operations, or cash flows.

 

Note 9: Income Taxes

 

The significant components of deferred tax assets as of December 31, 2016 and 2015 are shown below. A valuation allowance has been established to offset the deferred tax assets, as realization of such assets is uncertain.

 

    December 31,  
    2016     2015  
               
Excess of financial accounting over tax depreciation   $ 10,000     $ 20,000  
State income tax benefits     1,903,000       1,971,000  
Net operating loss carryforward     14,730,000       13,766,000  
Derivative liability expense     2,460,000       1,843,000  
Research and development credit carryforwards     711,000       663,000  
Obsolete inventory reserve     78,000       -  
Patent amortization     (408,000 )     (472,000 )
Vacation accrual     9,000       9,000  
Valuation reserve     (19,493,000 )     (17,800,000 )
Net deferred tax asset   $ -     $ -  

 

44  
 

 

The following reconciles the tax provision with the expected provision obtained by applying statutory rates to pretax income:

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

    December 31,  
    2016     2015  
             
Federal income tax benefit computed at the Federal statutory rate   $ (1,519,000 )   $ (1,236,000 )
Net operating loss     965,000       1,080,000  
Timing differences     641,000       291,000  
Permanent differences     (104,000 )     (27,000 )
Research and development credit     16,000       19,000  
Other     1,000       (127,000 )
Income tax benefit   $ -     $ -  

 

The components of federal income tax benefit from continuing operations consisted of the following for the year ended:

 

    December 31,  
    2016     2015  
             
Current income tax expense (benefit):                
Federal   $ -     $ -  
State     -       -  
                 
Net current tax expense (benefit)   $ -     $ -  
                 
Deferred tax expense (benefit) resulted from:                
Difference between financial and tax depreciation   $ 10,000     $ 12,000  
State income tax benefits     68,000       121,000  
Net operating loss     (965,000 )     (1,080,000 )
Research and development credits     (47,000 )     (57,000 )
Obsolete inventory reserve     (78,000 )     -  
Amortization of patents     (64,000 )     (64,000 )
Derivative liability recognition     (617,000 )     (293,000 )
Vacation accrual     -       1,000  
Warranty expense     -       5,000  
Valuation reserve     1,693,000       1,355,000  
                 
Net deferred tax benefit   $ -     $ -  
                 
    $ -     $ -  

 

At December 31, 2016, the Company had federal net operating loss carry-forwards of approximately $43,324,000 that expire from 2018 through 2036. In addition, the Company had research and development tax credits of approximately $648,000 that expire from 2018 through 2036. As a result of previous stock transactions, the Company’s ability to utilize its net operating loss carry-forwards to offset future taxable income and utilize future research and development tax credits is subject to certain limitations under Section 382 and Section 383 of the Internal Revenue Code due to changes in equity ownership of the Company.

 

45  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

The Company has a history of operating losses and, as of yet, has not had any taxable income. The Company has calculated a deferred tax asset for its tax credits but offsets the tax asset with a valuation allowance. As a result, the Company has not realized or recorded any tax benefit related to its tax credits.

 

Note 10: Lease Obligations

 

The Company leases its principal facility from an unrelated third party. The facility consists of approximately 5,080 square feet of office, research and development, manufacturing, quality testing, and warehouse space. The lease provides for monthly rental payments ranging from $5,120 in 2017 to $5,432 in 2018 plus an additional shared estimated facility cost of approximately $1,500 per month. Lease expense for the years ended December 31, 2016 and 2015 amounted to $79,950 and $76,520, respectively. The following is a schedule of minimum annual rental payments for the next five years:

 

Years ending December 31,      
       
2017   $ 63,282  
2018     21,727  
Thereafter     -  
         
Total minimum lease payments   $ 85,009  

 

Note 11: Equity Transactions

 

Series B Convertible Preferred Stock

 

There are authorized and outstanding 2,585,000 shares of Series B Convertible Preferred Stock (“Series B”). The Series B is convertible at $0.20 per common share and carries a liquidation preference of a like amount. At December 31, 2016 and 2015, the Series B had accumulated and unpaid dividends of $106,931. Due to a lack of authorized shares available, the preferred stock has been classified as mezzanine equity on the face of the balance sheet.

 

Series C Convertible Preferred Stock

 

There were authorized and outstanding at December 31, 2016, 500,000 shares of Series C Convertible Preferred Stock (“Series C”) which are convertible into a like amount of common shares. Due to a lack of authorized shares available, the preferred stock has been classified as mezzanine equity on the face of the balance sheet.

 

Series AA Preferred Shares

 

On April 15, 2016, the Board of Directors of the Company authorized an amendment to the Company’s Articles of Incorporation, as amended (the “Articles of Incorporation”), in the form of a Certificate of Designation that authorized the issuance of up to three thousand (3,000) shares of a new series of preferred stock, par value $0.001 per share, designated “Series AA Super Voting Preferred Stock,” for which the board of directors established the rights, preferences and limitations thereof.

 

Each holder of outstanding shares of Series AA Super Voting Preferred Stock shall be entitled to one million (1,000,000) votes for each share of Series AA Super Voting Preferred Stock held on the record date for the determination of stockholders entitled to vote at each meeting of stockholders of the Company.

 

46  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

The holders are restricted from voting the preferred shares for any proposal on the election of directors. The Company recorded a special dividend and valued the Series AA Super Voting Preferred Stock at $25,000 as of December 31, 2016.

 

Common Stock

 

During the year ended December 31, 2016, holders of Convertible Debentures with a face value of $169,486 converted their debentures and accrued interest into 452,424,015 shares of restricted common stock. In addition, associated with these debentures, the Company paid $24,189 in accrued interest, reduced debt discount by $167,217, reduced debt issuance costs by $11,672, reduced derivative liability by $1,232,152 and recorded a gain on extinguishment of debt of $504,002.

 

During the year ended December 31, 2015, holders of Convertible Debentures with a face value of $437,355 converted their debentures and accrued interest into 236,691,930 shares of restricted common stock. In addition, associated with these debentures, the Company paid $68,150 in accrued interest, reduced debt discount by $84,192, reduced debt issuance costs by $89,041, reduced derivative liability by $637,874 and recorded a gain on extinguishment of debt of $260,564.

 

In June 2015, an affiliate of the Company exercised a stock option with an exercise price of $0.01 per share for 200,000 shares of common stock.

 

Convertible Debentures

 

During 2016, the Company entered into subscription agreements with accredited investors to purchase an aggregate principal amount of $300,000 of Convertible Debentures and $1,100,000 of Secured Convertible Debentures initially convertible into shares of common stock at a conversion price of $0.01, together with five-year warrants on the Convertible Debentures to purchase approximately 15,000,000 common shares at an exercise price equal to $0.02 per share.

 

During 2015, the Company entered into subscription agreements with accredited investors to purchase an aggregate principal amount of $2,165,514 of Convertible Debentures with fixed conversion prices initially convertible into shares of common stock at a conversion prices ranging from $0.03 to $0.045, together with five-year warrants to purchase approximately 22,904,788 common shares at an exercise prices ranging from $0.06 to $0.09 per share.

 

Stock Options

 

As of December 31, 2016, the Company had one stock-based employee compensation plan under which it makes grants, the 2011 Equity Incentive Plan (the “EIP”) which has been approved by our shareholders in August 2014. The EIP provides for the grant of incentive stock options (“ISOs”), nonqualified stock options (“NQSOs”) and restricted stock awards to full-time employees (who may also be directors) and NQSOs and restricted stock awards to non-employee directors, consultants, customers, vendors or providers of services. The exercise price of any ISO may not be less than the fair market value of the common stock on the date of grant and the term shall not exceed ten years. At December 31, 2016, the Company had outstanding options to purchase up to 34,168,800 shares of common stock under the EIP and the Company’s prior Amended 2001 Stock Plan representing approximately 4% of the Company’s outstanding shares (25,392,839 of which were exercisable). Awards under the Company’s EIP generally vest over four years.

 

A summary of the status of the options granted under the Company’s 2011 EIP at December 31, 2016 and 2015, and changes during the years then ended is presented below:

 

47  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

          Outstanding Options        
      Options         Weighted Average  
            Weighted     Weighted     Remaining  
           

Average

Exercise

   

Average

Fair

    Contractual Terms in  
      Shares     Price     Value     Years  
                           
Outstanding, December 31, 2014         34,293,800     $ 0.02               8.99  
Granted       5,900,002     $ 0.01     $ 0.01          
Cancelled       (5,825,002 )   $ 0.02                  
Exercised         (200,000 )   $ 0.01                  
Outstanding, December 31, 2015       34,168,800     $ 0.02             8.03  
Granted       -     $ 0.00                
Cancelled       -     $ 0.00                
Exercised         -     $ 0.00                
Outstanding, December 31, 2016         34,168,800     $ 0.02             7.03  
                                 
                                 
                                 
                                 
                                 
Exercisable, December 31, 2016         25,392,839     $ 0.02             7.03  
Exercisable, December 31, 2015         20,061,168     $ 0.02             8.04  

 

There was no intrinsic value of the options outstanding under the EIP at December 31, 2016 and 2015.

 

A summary of the status of the options outstanding under the EIP at December 31, 2016, is presented in the table below:

 

      Outstanding     Exercisable  
            Weighted                    
            Average     Weighted           Weighted  
Range of           Remaining     Average           Average  
Exercise     Number     Contractual     Exercise     Number     Exercise  
Prices     Outstanding     Life     Price     Exercisable     Price  
                                 
  Options                                          
                                             
$ 0.01       1,200,000       8.10     $ 0.01       1,200,000 $     0.01  
$ 0.02       32,568,800       7.02     $ 0.02       23,792,839 $     0.02  
$ 0.06       200,000       4.85     $ 0.06       200,000 $     0.06  
$ 0.15       200,000       3.96     $ 0.15       200,000 $     0.15  
          34,168,800       7.03     $ 0.02       25,392,839 $     0.02  

 

48  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

There was one stock option exercised for 200,000 common shares during the year ended December 31, 2015. At December 31, 2016, total unrecognized estimated employee and director compensation cost related to stock options granted is $173,324, which is expected to be recognized over the next two to three years.

 

Warrants

 

During the year ended December 31, 2016, in conjunction with the sale of Convertible Debentures, the Company issued five-year common stock purchase warrants to acquire approximately 15,000,000 shares to holders of the Debentures with an exercise price of $0.02 per share.

 

In March 2016, the Company issued a three-year common stock purchase warrant exercisable into up to 1,000,000 shares of common stock with an exercise price of $0.04 and in November 2016, the Company issued two five-year common stock purchase warrants exercisable into up to 888,889 shares of common stock with an exercise price ranging from $0.06 to $0.09 for services provided by consultants. The value of these warrants was recorded as non-cash expense in an amount of $3,546 using the Black Sholes Option pricing method.

 

During the year ended December 31, 2015, in conjunction with the sale of Convertible Debentures and Notes, the Company issued five-year common stock purchase warrants with an exercise prices ranging from $0.06 to $0.09 per share to acquire up to 22,904,789 shares to holders of the Debentures.

 

A summary of the status of the warrants granted under various agreements at December 31, 2016 and 2015, and changes during the years then ended is presented below:

 

      Warrants  
            Weighted     Weighted  
            Average     Average  
            Exercise     Fair  
      Shares     Price     Value  
                     
Outstanding, December 31, 2014         103,430,075     $ 0.11          
                           
Granted       22,904,789     $ 0.08     $ 0.01  
Expired       (9,459,694 )   $ 0.31          
Exercised       -                  
Outstanding, December 31, 2015           116,875,170     $ 0.08          
                           
                           
Granted       16,888,889     $ 0.02     $ 0.003  
Expired       (1,485,838 )   $ 0.08          
Exercised       -     $ -          
Outstanding, December 31, 2016           132,278,221     $ 0.08          
                           
Exercisable, December 31, 2016       132,278,221     $ 0.08          
Exercisable, December 31, 2015       116,875,170     $ 0.08          

 

49  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

A summary of the status of the warrants outstanding at December 31, 2016 are presented in the table below:

 

      Outstanding     Exercisable  
            Weighted                    
            Average     Weighted           Weighted  
Range of           Remaining     Average           Average  
Exercise     Number     Contractual     Exercise     Number     Exercise  
Prices     Outstanding     Life     Price     Exercisable     Price  
                                 
  Warrants                                          
                                             
  $ 0.02-.0.04       16,000,000       4.04     $ 0.0213       16,000,000     $ 0.0213  
$ 0.06       7,842,602       3.71     $ 0.06       7,842,602     $ 0.06  
$ 0.0745       39,333,935       0.52     $ 0.0745       39,333,935     $ 0.0745  
$ 0.09       64,879,085       2.57     $ 0.09       64,879,085     $ 0.09  
$ 0.1287       4,222,599       0.95     $ 0.1287       4,222,599     $ 0.1287  
          132,278,221       2.15     $ 0.08       132,278,221     $ 0.08  

 

The fair value of options and warrants granted were estimated at the date of grant using a Black-Scholes Model which includes several variables including expected life, risk free interest rate, expected stock price volatility, stock option exercise patterns and expected dividend yield. The Company also must estimate forfeitures for employee stock options. These models and assumptions are complex and may change future expenses by increasing or decreasing stock-based compensation expense. Management used the following assumptions to value stock options and warrants granted during the years ended December 31, 2016 and 2015:

 

    Year Ended December 31,  
    2016     2015  
             
Expected term of options or warrants     3 years to 5 years       5 years  
Exercise price     $0.02 to $0.09     $ 0.01  
Expected volatility     241% to 279%       210 %
Expected dividends     None       None  
Risk-free interest rate     1.04% to 1.49%       1.48 %
Forfeitures     None       None  

 

In addition to the above, management estimated the forfeitures on employee options under the Option Plan would have negligible effects because such forfeitures would be a very small percentage. Management believes that options granted have been to a group of individuals that have a high desire to see the Company succeed and have aligned themselves to that end.

 

The expected lives us d in the calculations were selected by management based on past experience, forward looking profit forecasts and estimates of what the trading price of the Company’s stock might be at different future dates. Risk-free interest rates used are the five-year U.S. Treasury rate as published for the applicable measurement dates.

 

50  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

Volatility is a calculation based on fluctuations in the Company’s stock price over a historical time period consistent with the estimated life of the option.

 

Note 12: Fair Value Measurements

 

Accounting guidance on fair value measurements and disclosures defines fair value, establishes a framework for measuring the fair value of assets and liabilities using a hierarchy system, and defines required disclosures. It clarifies that fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the market in which the reporting entity transacts business.

 

The Company’s balance sheet contains derivative and warrant liabilities that are recorded at fair value on a recurring basis. The three-level valuation hierarchy for disclosure of fair value is as follows:

 

Level 1: uses quoted market prices in active markets for identical assets or liabilities.

 

Level 2: uses observable market-based inputs or unobservable inputs that are corroborated by market data.

 

Level 3: uses unobservable inputs that are not corroborated by market data.

 

The fair value of the Company’s recorded derivative and warrant liabilities is determined based on unobservable inputs that are not corroborated by market data, which require a Level 3 classification. A modified Black Scholes option valuation model was used to determine the fair value with similar assumptions to those described under “Stock-Based Compensation”. The Company records derivative and warrant liabilities on the consolidated balance sheets at fair value with changes in fair value recorded in the consolidated statements of operations.

 

51  
 

 

The following table presents the balances of liabilities measured at fair value on a recurring basis by level as of December 31, 2016 and 2015:

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

    Fair Value Measurements at December 31, 2016 Using  
    Quoted Prices in     Significant Other     Significant        
    Active Markets for     Observable     Unobservable        
    Identical Assets     Inputs     Inputs        
    (Level 1)     (Level 2)     (Level 3)     Total  
                         
 Derivative liability   $ -     $ -     $ 679,036     $ 679,036  
 Warrant liability     -       -       82,436       82,436  
 Commitment in excess of authorized stock     -       -       58,456       58,456  
Total   $ -     $ -     $ 819,928     $ 819,928  

 

    Fair Value Measurements at December 31, 2015 Using  
    Quoted Prices in     Significant Other     Significant        
    Active Markets for     Observable     Unobservable        
    Identical Assets     Inputs     Inputs        
    (Level 1)     (Level 2)     (Level 3)     Total  
                         
Derivative liability   $ -     $ -     $ 517,151     $ 517,151  
Warrant liability     -       -       38,742       38,742  
Total     -       -       64,428       64,428  
    $ -     $ -     $ 620,321     $ 620,321  

 

Note 13: Loss Per Share

 

Basic and diluted loss per share are the same for the fiscal years ended December 31, 2016 and 2015, since any additional common stock equivalents would be antidilutive. Potentially dilutive shares of common stock that have been excluded from the calculation of the weighted average number of dilutive common shares for the years ended December 31, 2016 and 2015 are as follows:

 

    Year Ended December 31,  
    2016     2015  
             
Preferred Stock     3,085,000       3,085,000  
Convertible debentures     544,971,248       603,338,377  
Options     34,168,800       34,168,800  
Warrants     132,278,221       116,875,170  
 Total     714,503,269       757,467,347  

 

The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2016 and 2015:

 

52  
 

 

SpectraScience, Inc. and Subsidiaries

Notes to Consolidated Financial Statements (continued)

 

    Year Ended  
    December 31,  
    2016     2015  
             
Numerator:                
Net loss for basic earnings per share   $ (4,466,567 )   $ (3,634,868 )
                 
Net loss for diluted earnings per share   $ (4,466,567 )   $ (3,634,868 )
                 
Denominator:                
Weighted average basic shares outstanding     697,694,480       216,335,085  
                 
Denominator for diluted earnings per share-adjusted weighted average shares     697,694,480       216,335,085  
                 
Loss per share                
Basic   $ (0.01 )   $ (0.02 )
Diluted   $ (0.01 )   $ (0.02 )

 

Note 14: Subsequent Events

 

Secured Convertible Debentures

 

From January 2017 through March 2017, the Company sold for cash Secured Convertible Debentures (the “Debentures”) to one accredited investor for aggregate consideration of $150,000. The Debenture matures in three years, carries a fixed conversion price of $0.01, an annual interest rate of 8%. The secured interest is on all of the assets of the Company and is shared equally with a previous secured party.

 

Variable Rate Convertible Debentures

 

From January 2017 through March 2017, holders of Variable Rate Convertible Debentures with face values of $87,751 converted their debentures and accrued interest into 529,648,837 shares of common stock. The same investors purchased $175,000 of previously issued and outstanding Unsecured Convertible Debentures for an exchange amount of $188,737 which included accrued and unpaid interest in an amount of $13,767. In addition, in February 2017, the Company entered into a variable rate note accumulating $70,000 that can be repaid for a premium ranging from 35% to 50% if paid within 90-180 days. If paid subsequent to 180 days, the notes are convertible into common stock at a discount to the market price.

 

Increase in Authorized Shares

 

On February 13, 2017, the increase in authorized capital stock from 1,250,000,000 shares to 2,000,000,000 shares became effective. The increase in authorized shares has been reflected on the Company’s Balance Sheet as of December 31, 2016.

 

Subsequent events have been evaluated through the date financial statements are filed with the Securities and Exchange Commission.

 

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

 

None.

 

ITEM 9A. CONTROLS AND PROCEDURES.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports, filed under the Securities Exchange Act of 1934, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

As required by the SEC Rule 13a-15(b), we carried out an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2016. Based on the foregoing, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective as of December 31, 2016.

 

Evaluation of Internal Control over Financial Reporting

 

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). The Company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with authorization of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.

 

Under supervision and with the participation of management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that evaluation, they concluded that as of December 31, 2016, such internal control over financial reporting was not effective.

 

Management’s assessment of the effectiveness of our internal control over financial reporting as of December 31, 2016 has not been attested to by Haynie & Company, the Company’s independent registered public accounting firm, as stated in their report which is included herein pursuant to rules of the Securities and Exchange Commission that permit the Company to provide only management’s report within this annual report.

 

54  
 

 

Changes in Internal Financial Controls

 

There was no change in the Company’s internal control over financial reporting that occurred during the Company’s most recently completed quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

ITEM 9B. OTHER INFORMATION.

 

None.

 

PART III

 

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE.

 

The following information is provided with respect to the directors and officers of the Company:

 

Name     Age     Director/Officer Since
Michael P. Oliver, President and Chief Executive Officer, Director     68     2011/2010
Lowell W. Giffhorn, Chief Financial Officer and Secretary     70     2013
Mark McWilliams, Chairman of the Board     60     2004
Sheldon L. Miller, Director     80     2010
Stanley Pappelbaum, M.D., Director     79     2006
F. Duwaine Townsen, Director     83     2009
Rand Mulford   73   2014

 

Michael P. Oliver, President and Chief Executive Officer, Director, joined SpectraScience as President and Chief Executive Officer in November 2010, and was elected a director in 2011. Prior to joining the Company and since 2007, Mr. Oliver was Executive Vice President for Worldwide Marketing and Business Development for Silicon Border Development, a privately-owned developer of industrial properties for high technology companies. From 2004 to 2007, Mr. Oliver was a Senior Vice President at Thomas Group, a consultancy that specialized in operational improvement. From 1998 to 2003, Mr. Oliver was engaged as in a business development role with PricewaterhouseCoopers working with medical device and technology companies. From 1990 to 1998 Mr. Oliver was a member of four separate management teams that took struggling medical device companies, increased their revenues and profitability and sold them to strategic buyers. In those companies he served in the capacity of head of sales and marketing and, in two cases, had major operational responsibilities as well. He began his career with American Hospital Supply Corporation serving in a variety of sales, marketing and general management positions. Mr. Oliver received his MSA from George Washington University and his BS from the United States Naval Academy. The Board believes that Mr. Oliver’s experience in the medical device and technology industries, as well as his success in increasing revenues for medical device companies, make Mr. Oliver a valuable resource for the Board.

 

Lowell W. Giffhorn, Chief Financial Officer and Secretary, joined the Company as Chief Financial Officer and Secretary in September 2013.Since 2005, Mr. Giffhorn has served as the Chief Financial Officer and Director of Brendan Technologies, Inc., a developer and marketer of computational analytical software products for the biopharmaceutical industry. Also since 2005, he serves as the Chief Financial Officer of Imagenetix, Inc., a publicly held nutritional supplement company. He was the Chief Financial Officer from 1997 to 2005 and a member of the Board of Directors from 1999 to 2006 of Patriot Scientific Corporation, a publicly held microprocessor and intellectual property firm. From 1992 to 1996 and from 1987 to 1990 he was the CFO of Sym-Tek Systems, Inc. and Vice President of Finance for its successor, Sym-Tek Inc., a supplier of capital equipment to the semiconductor industry. Previous to 1987, he held various financial management positions in industries including defense contracting, hospitality, and public accounting. He obtained a M.B.A. degree from National University in 1975 and a B.S. in Accountancy from the University of Illinois in 1969. He was also a director and chairman of the audit committee of DND Technologies, Inc., a publicly held company, until it was acquired in 2009. Mr. Giffhorn devotes approximately 50% of his time to our affairs.

 

55  
 

 

Mark McWilliams, Director. Since June 2007, Mr. McWilliams has served as the CEO of Medipacs, Inc., a development stage infusion pump company. From December 2003 to November 2005, Mr. McWilliams was Director of Cell Imaging and Analysis at Beckman Coulter after the sale of Q3DM to Beckman in December 2003. He was President and Chief Executive Officer and Director of Q3DM, from October 2001 to December 2003, a life-sciences startup that raised several angel and venture capital funding rounds that was acquired by Beckman Coulter. Previously, he was founder and COO of Medication Delivery Devices (“MDD”), an alternate care infusion systems company that was acquired by Baxter Healthcare in 1996. Mr. McWilliams served as a VP of Research and Development at Baxter Healthcare for three years following the sale of MDD. Prior to MDD, he served as Product Development Manager at the founding of Block Medical where he was responsible for bringing the company’s first two FDA approved products rapidly to market. Block was sold to Hillenbrand Industries in 1991. He previously worked for Hughes Aircraft, Vacuum General and Martin Marietta. Mr. McWilliams brings his expertise in managing and growing small technology companies and his strong network of contacts within the medical devices industry, to the Board of Directors. He earned his MSME from the Massachusetts Institute of Technology, his BSME from Northeastern University and holds eight utility patents.

 

Sheldon L. Miller, Director . Sheldon L. Miller has been a litigator and expert counsel for more than forty years and in private practice for more than 30 years. Mr. Miller has operated the Law Office of Sheldon Miller, PC for the past 30 years. Mr. Miller was a member of the Board of Governors of the American Trial Lawyers Association from 1977 through 2009 (longest tenure in history). From 1979 through 1992, he was the President of the Mediation Tribunal Association in Wayne County (Detroit), Michigan. In 1971, he pioneered the concept of mediation and was the first mediator on behalf of the Plaintiff’s Bar in the State of Michigan. Mr. Miller was also the first to prosecute and articulate the concept of “comparative negligence” in the State of Michigan. Mr. Miller graduated from Wayne State University Law School in Detroit in 1961. Mr. Miller brings his considerable experience in legal risk analysis and responsibility to the Board of Directors.

 

Stanley J. Pappelbaum M.D., Director. Dr. Pappelbaum has been Managing Partner of Pappelbaum, Turner & Associates, a national healthcare consultancy company that advises hospital, medical group, health insurance, and governmental healthcare clients, since 2000. Dr. Pappelbaum joined Scripps hospital in 1996 as Chief Transformational Officer in charge of creating and implementing Scripps’ strategic vision of the future. In 1997, he was promoted to Executive Vice President and Chief Operating Officer and, in 1999, he was promoted to President and Chief Executive Officer when the hospital reached annual revenues of over $1 billion. From 1985 to 1995, he was the managing partner of Professional Health Consulting Group, a national company of physician executives that analyzed and managed change for complex not-for-profit healthcare systems clients throughout the United States. From 1969 to 1984, Dr. Pappelbaum taught and practiced Pediatric Cardiology at the University of California, San Diego and at San Diego Children’s Hospital, where he was Chief of Pediatric Cardiology from 1972 to 1978. Dr. Pappelbaum completed his undergraduate work at McGill University in Montreal and received his medical degree from the University of British Columbia Faculty of Medicine in Vancouver. He completed his residency in pediatric medicine at Montreal Children’s Hospital of McGill University and did graduate studies in cardiovascular physiology and a fellowship in pediatric cardiology at the University of California, Los Angeles. He also was awarded an Alfred P. Sloan Fellowship at the Massachusetts Institute of Technology, where he earned a Master’s degree in management (health option). Dr. Pappelbaum brings his intimate knowledge of the healthcare industry and familiarity with recent changes in the healthcare environment to the Board of Directors.

 

F. Duwaine Townsen, Director. Mr. Townsen co-founded and has been the Managing Partner of EndPoint Late-Stage Fund of San Diego since 1999. This fund invests exclusively in late-stage life science companies. Mr. Townsen co-founded the Ventana Growth Funds in 1982 and served as the group’s Managing Partner directing investments in early and middle stage life-science, high-technology and telecommunications companies. Prior to this, Mr. Townsen was the CEO and Chairman of Kay Laboratories, Inc., a medical device company, where he led the company through a successful IPO in 1978 and subsequent sale to American Hospital Supply Corporation in 1981. Following his public accounting experience, Mr. Townsen became a founder and Chief Financial Officer of Oceanographic Engineering Corporation and guided the company to profitability and its sale to Dillingham Corporation in 1967. Mr. Townsen serves as a director on the board of Sequal Technologies, a privately held high-technology company and has held numerous directorships at private and public companies, some of which included Agouron Pharmaceuticals, Inc., Brooktree Corporation, Cymer, Inc. and Maxim Pharmaceuticals, Inc. Mr. Townsen began his career with Arthur Young & Co. after graduating from San Diego State University. Mr. Townsen brings his specific public accounting environment and public markets experience to the Board of Directors, as well as his deep expertise related to corporate governance and fiduciary responsibility issues.

 

56  
 

 

Rand Mulford, Director. Mr. Mulford has for the past five years successfully completed a variety of projects including managing M&A transactions, developing strategy for companies in therapeutic antibodies, cell-based therapy for eye diseases, prescription drug distribution, and developing a potential cure for AIDS. Previously, Mr. Mulford had joined with two other partners to found a specialty pharmaceutical company. Before that, he was E.V.P for Strategy with Chatham Capital and Forest Health Services, a for-profit chain of hospitals. For two years, Mr. Mulford worked with a venture capital firm working directly with four portfolio companies. His corporate experience includes: Group V.P. of planning and control for a petrochemical company; head of corporate planning at Merck; C.F.O. of a human tissue company; C.O.O. of a drug discovery company and president of its subsidiary, a research chemical company; C.O.O. of a diagnostics company; Chairman of the Board of a medical device company; and head of the corporate development at a bio-pharmaceutical company. Mr. Mulford started his business career with the consulting firm of McKinsey & Co. During an eight-year period, he served about twenty clients working on a variety of issues primarily related to strategy and organization. Rand obtained a bachelor’s degree in engineering with honors from Princeton University in 1965. For the next five years he served as a naval officer in the nuclear submarine program. Subsequently, he earned an M.B.A. with high distinction at Harvard Business School. Mr. Mulford brings his past financial and operational expertise to the Board of Directors.

 

Our Board of Directors has the responsibility for establishing broad corporate policies and for overseeing our overall performance. Members of the Board are kept informed of our business activities through discussions with the CEO and other officers, by reviewing analyses and reports sent to them, and by participating in Board and committee meetings. Our bylaws provide that each of the directors serves for a term that extends until resignation or replacement.

 

Code of Ethics. The Company has adopted a code of ethics applicable to its chief executive officer, senior financial officer and other employees. The code is available at no charge by request to the Company in writing, to the attention of the CFO. The Code is also available on the Corporate Governance section of the Company’s website at www.spectrascience.com . The Company intends to satisfy Form 8-K disclosure requirements by including on its website any amendment to, or waiver from, a provision of its Ethics or Code of Conduct policy that applies to the principal executive officer, principal financial officer, principal accounting officer and controller that relates to any element of the code of ethics definition enumerated in Item 406(b) of Regulation S-K under the Securities Act of 1933.

 

SECTION 16(a) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE

 

Section 16(a) of the Securities Exchange Act of 1934 requires the Company’s executive officers and directors, and persons who own more than ten percent of the Company’s Common Stock, to file with the Securities and Exchange Commission initial reports of ownership and reports of changes in ownership of Common Stock and other equity securities of the Company. Officers, directors and greater than ten percent shareholders (“Insiders”) are required by SEC regulation to furnish the Company with copies of all Section 16(a) forms they file.

 

To the Company’s knowledge, based on a review of the copies of such reports furnished to the Company during the fiscal year ended December 31, 2016, all Section 16(a) filing requirements applicable to Insiders were complied with.

 

Audit Committee Financial Expert. The Audit Committee of the Board of Directors is comprised of four non-employee directors; F. Duwaine Townsen (Chairman), Mark McWilliams, Rand Mulford and Dr. Stanley Pappelbaum. The Board of Directors has determined that Mr. Townsen is an audit committee financial expert and is independent as defined under NASDAQ Rule 5605(a)(2).

 

57  
 

 

ITEM 11. EXECUTIVE COMPENSATION

 

Summary Compensation Table for 2016

 

The following table summarizes compensation awarded to, earned by or paid to the Company’s Chief Executive Officer and other executive officers who were “Named Executive Officers” during the years ended December 31, 2016, 2015 and 2014.

 

Name and   Fiscal           Deferred     Option     All Other        
Principal Position   Year     Salary ($)     Compensation ($)     Awards ($)     Compensation ($)     Total ($)  
                                     
Michael P. Oliver (1)     2016     $ 325,000     $ -     $ -     $ -     $ 325,000  
President, CEO and Director     2015     $ 325,000     $ 183,333     $ -     $ -     $ 508,333  
      2014     $ 241,667     $ -     $ 239,014     $ -     $ 480,681  
                                                 
Lowell W. Giffhorn (2)     2016     $ 90,000     $ -     $ -     $ -     $ 90,000  
CFO and Secretary     2015     $ 90,000     $ -     $ -     $ -     $ 90,000  
      2014     $ 90,000     $ -     $ 89,630     $ -     $ 179,630  

 

(1) Mr. Oliver was appointed President and CEO on November 29, 2010. In January 2014, we entered intoan employment agreement with Mr. Oliver. Per the terms of the agreement, Mr. Oliver’s base salary was $225,000 per year until the company accumulated at least $2,000,000 of equity financing in one transaction or $3,000,000 in the aggregate at which time his base salary was increased to $325,000 per year. He will be entitled to an annual bonus of up to 50% of his base salary based on performance criteria to be determined by the Board of Directors. He shall be entitled to 12 month’s severance pay if terminated for reasons otherthan cause, as defined in the agreement, and an additional 12 month’s severance if a change in control action, as defined in the agreement, takes place.
     
(2) Mr. Giffhorn’s employment with the Company started in September 2013. Mr. Giffhorn devotes approximately 50% of his time to the Company’s affairs.
     
(3) The value of each option award is the grant date fair value as determined under FASB ASC Topic 718, Compensation – Stock Compensation, or ASC 718.

 

Pension Benefits. The Company does not have a pension benefit plan.

 

Nonqualified Deferred Compensation. Mr. Oliver deferred $183,333 of compensation during 2015 which represented the difference between his annual salary and the amount he was paid previous to the time before the Company accumulated at least $3,000,000 in accumulated financings. This amount became payable in 2015.

 

Outstanding Equity Awards at Fiscal Year End. The following table describes the outstanding stock option grants to named executive officers at year end. There are no Stock Awards issued or outstanding.

 

58  
 

 

Name   Number     Number     Option     Option  
    of     of     Exercise     Expiration  
    Securities     Securities     Price     Date  
    Underlying     Underlying     ($)        
    Unexercised     Unexercised              
    Options     Options              
      (#)       (#)                  
      Exercisable       Unexercisable                  
                                 
Michael P. Oliver (1)     9,454,155       2,545,845     $ 0.02       1/10/2024  
President, CEO and                                
Director                                
                                 
Lowell W. Giffhorn (2)     1,500,000       3,000,000     $ 0.02       1/10/2024  
CFO and Secretary                                

 

    1)

Option vests over four years, with 2,600,000 vesting on grant and 195,833 vesting per month for 48 months.

       
    2)

Option vests over four years, with 1,500,000 vesting on grant and 62,500 vesting permonth for 48 months subject to Mr. Giffhorn accepting full-time employment withthe Company.

 

Compensation of Directors.

 

The Company does not pay directors for Board of Directors’ meetings or committee meetings attended, but reimburses each such director for reasonable travel and out-of-pocket expenses for attendance at these meetings. Each sitting director is awarded annually a stock option to purchase a number of shares of common stock at an exercise price equal to market price on the date of grant. The number of shares to be granted is determined by the Board of Directors on a recommendation by the Compensation Committee.

 

The options granted to employee and non-employee directors under the EIP expire ten years from the date of grant (subject to earlier termination in the event of death or termination), are not transferable (except by will or the laws of descent and distribution).

 

59  
 

 

The following table shows the fair value of the compensation earned by each of our non-employee directors who received stock option grants during the year ended December 31, 2016:

 

DIRECTOR COMPENSATION FOR 2016

 

Name   Fees     Option     Total  
    Earned     Awards     ($)  
    or     ($)        
    Paid In              
    Cash              
    ($)              
Mark McWilliams   $ -     $ 1,484     $ 1,484  
Sheldon L. Miller   $ -     $ 1,496     $ 1,496  
Stanley Pappelbaum, M.D.   $ -     $ 1,016     $ 1,016  
F. Duwaine Townsen   $ -     $ 1,372     $ 1,372  
Rand Mulford   $ -     $ -     $ -  

 

The option awards amount represent the value of the current year amortization of stock options issued in prior years.

 

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS.

 

Summary of Securities Authorized for Issuance Under Equity Compensation Plans

 

The following table sets forth December 31, 2016 information on our equity compensation plans in effect as of that date:

 

                Number of securities
      Number of securities             remaining availablefor issuance under
      to be issued upon       Weighted average     equity compensaton
      exercise of       exercise price of     plans (excluding
      outstanding options,       outstanding options,     securities reflected in
      warrants and rights       warrants and rights     column (a))
Plan Category     (a)       (b)     (c)
                     
Equity compensation                    
plans approved by                    
security holders     34,168,800     $ 0.02     831,200
                     
Equity compensation                    
plans not approved                    
by security holders     -             -
                     
Total     34,168,800     $ 0.02     831,200

 

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EQUITY COMPENSATION PLAN INFORMATION

 

2011 Equity Incentive Plan

 

The Board adopted the 2011 SpectraScience, Inc. Equity Incentive Plan in February 2011 (the “EIP”) it was approved by the shareholders in August 2014. The EIP provides for the grant of ISOs, NSOs, restricted stock awards, restricted unit awards, stock appreciation rights and performance awards to full-time employees (who may also be directors), non-employee directors, consultants, advisors or providers of services. The exercise price of any ISO may not be less than the fair market value of the common stock on the date of grant and the term shall not exceed ten years. At December 31, 2016, the amount reserved under the EIP is 35,000,000 shares of common stock with stock option grants for 34,168,800 common shares outstanding and 831,200 shares of common stock available for future stock option grants.

 

OWNERSHIP OF COMMON STOCK

 

The following table shows as of March 31, 2017, the stock ownership of (i) all persons known by us to be beneficial owners of more than five percent of our outstanding shares of Common Stock, (ii) each director and each nominee for election as a director, (iii) the Named Executive Officers (as defined above in the section titled “Executive Compensation”), and (iv) all current directors and executive officers as a group.

 

Beneficial ownership of the Common Stock is determined in accordance with the rules of the SEC and includes any shares of Common Stock over which a person exercises shared or sole voting or investment powers, or of which a person has a right to acquire ownership at any time within 60 days of March 31, 2017. Except as otherwise indicated, and subject to applicable community property laws, the persons named in this table have sole voting and investment power with respect to all shares of Common Stock held by them. Applicable percentage ownership in the following table is based on 1,320,313,586 shares of Common Stock outstanding as of March 31, 2017, plus for each individual, any securities that individual has the right to acquire within 60 days of March 31, 2017.

 

Unless otherwise indicated below, the address of each principal shareholder is c/o SpectraScience, Inc., 11568-11 Sorrento Valley Road, San Diego, California 92121.

 

         

Percentage of

 Outstanding Stock

   

Percentage of

Aggregate

Voting Power

 
Name of Beneficial Owner   Title of Class of Stock  

Shares Beneficially

Owned (1)

    of Respective Class    

of Common

and Series AA

 
Sheldon L. Miller (2)(10)   Common     4,795,998       *       *  
Michael P. Oliver (3)(11)(10)   Common     9,894,821       *       *  
Stanley Pappelbaum M.D. (4)(10) (12)   Common     1,001,511,693       *          
    Series AA Super Voting     1,000       33.3 %     22.6 %
Mark McWilliams (5)(10) (12)   Common     1,002,036,913       *          
    Series AA Super Voting     1,000       33.3 %     22.6 %
F. Duwaine Townsen (6)(10)   Common     1,065,484       *       *  
Lowell W. Giffhorn (7) (11)   Common     1,500,000       *       *  
Rand Mulford (8) (12)   Common     1,000,400,000       *          
    Series AA Super Voting     1,000       33.3 %     22.6 %
                             
All officers and directors as a group (9) (7 persons)   Common     3,021,201,909       1.5 %     68.2 %
    Series AA Super Voting     3,000       100 %        

 

* Less than 1%

 

61  
 

 

1) Beneficial ownership is determined in accordance with Rule 13d-3(a) of the Securities Exchange Act of  1934 and generally includes voting or investment power with respect to securities. Except as indicated by footnotes and subject to community property laws, where applicable, the person named above has sole  voting and investment power with respect to all shares of the Common Stock shown as beneficially owned  by him or her.
   
2) Includes 1,061,693 shares which may be acquired upon exercise of options which are currently exercisable or which become exercisable within 60 days of March 31, 2017
   
3) Includes 9,845,821 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017.
   
4) Includes 1,461,693 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017.
   
 5) Includes 54,284 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017.  Also includes warrants to purchase 162,697  shares of Common Stock.
   
 6) Includes 1,065,484 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017.
   
 7) Includes 1,500,000 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017.
   
8) Includes 200,000 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017
   
9) Includes 15,668,975 shares which may be acquired upon the exercise of options which are currently exercisable  or which become exercisable within 60 days of March 31, 2017.  Also includes warrants to purchase 162,697 shares of Common Stock.
   
10) Director
   
11) Executive Officer

 

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

 

Related Party Transactions

 

There have been no transactions during the last two fiscal years to which we have been a party in which the amount involved exceeded 1% of the Company’s average total assets for the last two fiscal years and in which any of our executive officers, directors or beneficial holders of more than 5% of our capital stock had or will have a direct or indirect material interest.

 

Director Independence

 

Although the Company is not listed on a national securities exchange, the Company has chosen to evaluate independence based upon the NASDAQ listed company rules. The Company has determined thatMessrs.McWilliams, Miller, Pappelbaum, Sievert, Mulford and Townsen are independent under NASDAQ Rule 5605(a)(2). Mr. Oliver is not independent under NASDAQ Rule 5605(a)(2) because he has an employment relationship with the Company. Other than Mr. Oliver, the remaining directors of the Company are independent in that they have no relationship to the corporation that may interfere with the exercise of their independence from management and the Company. No independent director has a business or family relationship with another director to the best of management’s knowledge.

 

62  
 

 

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.

 

Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditor

 

Our audit committee of the Board of Directors is responsible for pre-approving all audits and permitted non-audit services to be performed for us by our independent auditor.

 

Our Audit Committee must pre-approve all audit services, engagement fees and terms, and all permitted non-audit engagements, subject to the de minimus exceptions permitted pursuant to the Securities Exchange Act of 1934. All audit-related fees were approved by our Audit Committee in fiscal 2016.

 

Independent Public Accountants’ Fees.

 

The following table presents fees for professional services rendered for the two most recent fiscal years.

 

Fee category   2016     2015  
             
Audit fees   $ 88,900       88,000  
                 
Audit-related fees   $ -       -  
                 
Tax fees   $ 1,600       1,600  
                 
All other fees   $ -       -  
                 
Total fees   $ 90,500       89,600  

 

1)

Audit fees include fees billed and expected to be billed for professional services rendered for the audit of our annual consolidated financial statements for the fiscal years ended December 31, 2016 and 2015, the review of our financial statements included in our reports on Form 10-Q, and accounting consultations necessary for the rendering of an opinion on our consolidated financial statements.

   
2) Audit-related fees include fees billed and expected to be billed for professional services rendered primarily for consultation and review of securities registration filings and related consents for the fiscal years ended December 31, 2016 and 2015.

 

63  
 

 

PART IV

 

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

(a)   Documents filed as part of this report.
     
  1) Financial Statements. The following financial statements are included in Part II, Item 8 of this Annual Report on Form 10-K
     
    Reports of Independent Registered Public Accounting Firm
     
    Consolidated Balance Sheets as of December 31, 2016 and 2015
     
    Consolidated Statements of Operations for the years ended December 31, 2016 and 201
     
    Consolidated Statements of Shareholders’ Equity from December 31, 2014 to December 31, 2016
     
    Consolidated Statements of Cash Flows for the years ended December 31, 2016 and 2015
     
    Notes to Consolidated Financial Statements
     
  2) Financial Statement Schedules. Not applicable.
     
  3) Exhibits. See “Exhibit Index to Form 10-K” immediately following the signature page of thisForm 10-K for a description of the documents that are filed as Exhibits to this report or incorporatedby reference herein.

 

64  
 

 

SIGNATURES

 

Pursuant to the requirements of Sections 13 and 15(d) 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.

 

  SpectraScience, Inc.
  (Registrant)
     
Date: March 31, 2017 By: /s/ Michael P. Oliver
    Michael P. Oliver - President and
    Chief Executive Officer

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

 

/s/ Michael P. Oliver  
Michael P. Oliver   Date: March 31, 2017
President and Chief Executive Officer, Director    
(Principal Executive Officer)    
     
/s/ Lowell W. Giffhorn    
Lowell W. Giffhorn   Date: March 31, 2017
Chief Financial Officer and Secretary    
(Principal Financial and Accounting Officer)    
     
/s/ Mark D. McWilliams    
Mark D. McWilliams   Date: March 31, 2017
Director    
     
/s/ Stanley J. Pappelbaum    
Stanley J. Pappelbaum   Date: March 31, 2017
Director    
     
/s/ Duwaine Townsen    
Duwaine Townsen   Date: March 31, 2017
Director    
     
/s/ Sheldon L. Miller    
Sheldon L. Miller   Date: March 31, 2017
Director    
     
/s/ Rand Mulford   Date: March 31, 2017
Rand Mulford    
Director        

 

65  
 

 

Exhibit No.   Description
2.1   Stock Purchase Agreement by and among the Company, Euclid Partners IV, L.P., EuclidSR Partners, L.P., EuclidSR Biotechnology Partners IV, L.P., Stephen L. Watson and Ross Flewelling (Incorporated by reference to exhibit 2.1 to the Company’s Report on Form 8-K filed on November 13, 2007)
     
3.1   Amended and Restated Articles of Incorporation dated August 2, 2004 (Incorporated by reference to exhibit 3.1 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.2   Certificate of Amendment to Articles of Incorporation dated September 21, 2009 (Incorporated by reference to exhibit 3.2 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.3   Amendment to Amended and Restated Articles of Incorporation dated July 13, 2012 (Incorporated by reference to exhibit 3.3 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.4   Amendment to Amended and Restated Articles of Incorporation dated August 21, 2014 (Incorporated by reference to exhibit 3.4 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.5   Amendment to Amended and Restated Articles of Incorporation dated August 6, 2016 (Incorporated by reference to exhibit 3.5 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.6   Amended Bylaws dated November 15, 2012 (Incorporated by reference to exhibit 3.6 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.7   Certificate of Designations Series A dated June 12, 2007 (Incorporated by reference to exhibit 3.7 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.8   Certificate of Designaitons Series B dated June 22, 2009 (Incorporated by reference to exhibit 3.8 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.9   Certificate of Designations Serices C dated April 9, 2010 (Incorporated by reference to exhibit 3.9 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.10   Certificate of Designations Series AA Super Voting dated April 15, 2016 (Incorporated by reference to exhibit 3.10 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)
     
3.11   Certificate of Designations Series A, Series B, Series C, Series AA dated June 28, 2016 (Incorporated by reference to exhibit 3.11 to the Company’s Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 14, 2016)

 

66  
 

 

Exhibit No.   Description
3.12   Amended and Restated Articles of Incorporation dated January 10, 2017 (Incorporated by reference to Appendix A to the Company’s Preiminary Information Statement on Schedule 14C, filed on January 11, 2017)
     
4.1   Warrant to Purchase Series A Preferred Stock of SpectraScience, Inc. (Incorporated by reference to exhibit 4.2 to the Company’s Report on Form 10-QSB for the quarter ended June 30, 2007, filed on August 14, 2007)
     
4.2   Common Stock Purchase Warrant issued to Placement Agent (Incorporated by reference to exhibit 4.3 to the Company’s Report on Form 10-KSB for the fiscal year ended December 31, 2005, filed on March 31, 2008)
     
4.3   Form of Warrant to Purchase Common Stock of SpectraScience, Inc. issued to Holders of Series B  Preferred Stock (Incorporated by reference to exhibit 4.5 to the Company’s Report on Form 8-K filed on November 6, 2009)
     
4.4   Form of Warrant to Purchase Common Stock of SpectraScience, Inc. issued to Holders of Series C  Preferred Stock(Incorporated by reference to exhibit 4.5 to the Company Report on Form 8-K filed June 24, 2010)
     
4.5   Form of Agent Warrant for Series C Preferred Stock offering (Incorporated by reference to exhibit 4.6  to the Company’s Registration Statement on Form S-1/A filed on August 26, 2010)
     
4.6   Form of Debenture issued by the Company to each subscriber in the Company’s Convertible Debenture  Offering (Incorporated by reference to exhibit 4.1 to the Company’s Report on Form 8-K filed on January 30, 2013)
     
4.7   Offering (Incorporated by reference to exhibit 4.2 to the Company’s Report on Form 8-K filed on  January 30, 2013)
     
10.1   Common Stock Purchase Agreement dated as of January 30, 2009, by and between SpectraScience, Inc.  and Fusion Capital Fund II, LLC (Incorporated by reference to exhibit 10.1 to the Company’s Report on  Form 8-K filed on February 4, 2009)
     
10.2   Registration Rights Agreement dated as of January 30, 2009, by and between SpectraScience, Inc. and  Fusion Capital Fund II, LLC. (Incorporated by reference to exhibit 10.2 to the Company’s Report on  Form 8-K filed on February 4, 2009)
     
10.3*   Amended 2001 Stock Plan (Incorporated by reference to exhibit 10.27 to the Company’s Report on  Form 8-K filed on August 6, 2004 and to Registration Statement on Form S-8 dated September 9, 2005)
     
10.4*   Form of Directors’ Option Agreement (Incorporated by reference to exhibit 10.1 to the Company’s  Report on Form S-1 filed April 30, 2009)
     
10.5*   2011 Equity Incentive Plan (Incorporated by reference to exhibit 10.1 to the Company’s Report on  Form 8-K filed on March 1, 2012)

 

67  
 

 

Exhibit No.   Description
 10.6  * Form of Nonqualified Stock Option Award Agreement (Incorporated by reference to exhibit 10.2 to the Company’s Report on Form 8-K filed on March 1, 2012)
     
 10.7  * Offer Letter to Michael P. Oliver (Incorporated by reference to Exhibit 10.7 to the Company’s Report on Form 10-K for the fiscal year ended December 31, 2010, filed on March 31, 2012)
     
10.8   Dealer Agreement dated April 6, 2010 by and between the Company and Felix Investments, LLC (Incorporated by reference to exhibit 10.6 to the Company’s Registration Statement on Form S-1/A filed on August 26, 2010)
     
10.9   Dealer Agreement dated July 2, 2009 by and between the Company and Felix Investments, LLC (Incorporated by reference to exhibit 10.5 to the Company’s Registration Statement on Form S-1/A filed on August 26, 2010)
     
10.10   Form of Subscription Agreement by and between the Company and each Subscriber for the Company’s Convertible Debenture Offering (Incorporated by reference to exhibit 10.1 to the Company’s Report on Form 10-K filed on April 18, 2012)
     
10.11   Form of Subscription Agreement by and between the Company and each Subscriber for the Company’s Convertible Debenture Offering (Incorporated by reference to exhibit 10.1 to the Company’s Report on Form 10-Q filed on March 28, 2014)
     
10.12   Form of Convertible Debenture by and between the Company and each Subscriber for the Company’s Convertible Debenture Offering (Incorporated by reference to exhibit 10.2 to the Company’s Report on Form 10-Q filed on March 28, 2014)
     
10.13   Form of Warrant for each Subscriber for the Company’s Convertible Debenture Offering (Incorporated by reference to exhibit 10.3 to the Company’s Report on Form 10-Q filed on March 28, 2014)
     
10.14   Employment Agreement of Michael P. Oliver dated January 1, 2013 (Incorporated by reference to Exhibit 10.14 to the Company’s Report on Form 10-K filed on June 27, 2014)
     
 21  + Subsidiaries of the registrant – Luma Imaging Corporation, a Delaware corporation, SpectraScience International, Inc., a Minnesota corporation, and SpectraScience (UK) Ltd., a foreign Entity
     
 23.1  + Consent of Independent Registered Public Accounting Firm- Haynie & Company
     
 31.1  + Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
 31.2  + Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
 32.1  + Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
 32.2  + Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
 101.0  + Financial statements from the annual report on Form 10-K of the Company
     for the year ended December 31, 2016, formatted in XBRL; (i) the
     Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations,
     (iii) the Consolidated Statement of Shareholders’ Equity, (iv) the Consolidated
     Statements of Cash Flows, and (v) the Notes to the Consolidated Financial
     Statements.
     
   + Filed herewith
     
   * Denotes management compensatory plan or contract.

 

68  
 
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