·

Revenue for OVA1 increased in the third quarter 12% compared to the same quarter in 2017 and 18% sequentially compared to the second quarter of 2018 driven by strong price realization.

·

Expanded the overall Commercial team to 20, while strengthening the skillset of the team to focus on large practices

·

In contracting phase with two OBGyn super groups which will utilize our newly launched platform and cloud service offering for decentralizing OVA1 testing. The platform and web service will allow OVA1 and its OVA Calc to be performed locally on the premises. Decentralizing OVA1 allows for increased reach to more patients, “real time” testing, and access to previously inaccessible markets.

·

Signed a payer coverage agreement with Clalit Health Services in Israel. Clalit Health Services is Israel’s largest HMO and healthcare provider with approximately 3.8 million insured members or about half of the insured population. OVA1 is being offered as part

of the "Clalit Mushlam Coverage". Clalit Mushlam provides wider access to medical services that members can purchase above and beyond the minimum level of medical services provided under Israel’s National Health Insurance Law. The testing in Israel will be distributed via ProGenetics,

·

Entered into a comprehensive study agreement with Clalit Health Services to validate OVA1® (MIA), OVERA® (MIA2G) and OVA1®+ on the Israeli population.  Our technology will be studied on this high risk BRCA population to determine if earlier stage disease can be diagnosed and if the time to surgical treatment can be expedited for improved surgical outcomes for patients with an adnexal mass. 

·

Launched the new enhanced reflex offering OVA1+ which is designed to improve accuracy and reduce false positives by nearly 40% by leveraging the strengths of OVA1’s sensitivity and Overa’s specificity.  This new offering will also be available through a decentralized structure.

·

Presented CA125 Disparity data at Mid-Atlantic Gynecologic Oncology Society. Abstract and Manuscript submitted for National publication.

·

Expanded coverage by 2 million bringing total covered lives to 131M.

·

Total revenue in the third quarter of 2018 was $774 thousand compared to $699 thousand in the prior year quarter. Product revenue in the third quarter of 2018 totaled $739 thousand compared to $657 thousand in the prior year quarter, representing a 12% year-over-year increase. 1,981 OVA1 tests were performed in the third quarter of 2018, versus 1,954 OVA1 tests performed in the prior year quarter.

·

Revenue on a per-test-performed basis was $373 in the third quarter of 2018, representing a 11% increase over revenue per test performed of $336 in the third quarter of 2017.

·

Total operating expenses in the third quarter of 2018 was $2.6 million compared to $2.4 million in the same year-ago quarter, representing an increase of 9%. The increase is primarily attributable to increased investment in sales and marketing resources.

·

Net loss attributable to common shareholders for the third quarter of 2018 was $2.7 million or $(0.04) per share, as compared to a net loss of $3.5 million or $(0.06) per share after giving effect to the deemed dividend in the same year-ago quarter.

·

There were 75.4 million common shares outstanding at September 30, 2018.

·

Cash and cash equivalents at September 30, 2018 were $11.8 million.

·

The company utilized $2.4 million in cash in the third quarter of 2018.





September 30,

December 31,



2018

2017

Assets

Current assets:

Cash and cash equivalents

$

$

Accounts receivable, net

Prepaid expenses and other current assets

Inventories

Total current assets

Property and equipment, net

Other assets

 -

Total assets

$

$



Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

$

Accrued liabilities

Short-term debt

Other current liabilities

 -

Total current liabilities

Non-current liabilities:

Long-term debt

Total liabilities

Commitments and contingencies

Stockholders’ equity:

Preferred stock, par value $0.001 per share, 5,000,000 shares authorized at

September 30, 2018 and December 31, 2017; none issued and outstanding at

September 30, 2018 and December 31, 2017

 -

 -

Common stock, par value $0.001 per share, 150,000,000 shares authorized at

September 30, 2018 and December 31, 2017; 75,382,684 and 60,036,017 shares

issued and outstanding at September 30, 2018 and December 31, 2017,

respectively

Additional paid-in capital

Accumulated deficit

Total stockholders’ equity

Total liabilities and stockholders’ equity

$

$





Three Months Ended September 30,

Nine Months Ended September 30,



2018

2017

2018

2017

Revenue:

Product

$

$

$

$

Service

Total revenue

Cost of revenue:(1)

Product

Service

Total cost of revenue

Gross profit (loss)

Operating expenses:

Research and development(2)

Sales and marketing(3)

General and administrative(4)

Total operating expenses

Loss from operations

Interest income (expense), net

Other income (expense), net

 -

Net loss

$

$

$

$

Deemed dividend on warrant repricing

 -

 -

Net loss attributable to common stockholders

$

$

$

$

Net loss per share attributable to common stockholders - basic and diluted

$

$

$

$

Weighted average common shares used to compute basic and diluted net loss per common share

Non-cash stock-based compensation expense included in cost of revenue and operating expenses:

(1)  Cost of revenue

$

$

$

$

(2)  Research and development

(3)  Sales and marketing

(4)  General and administrative