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New reagent examines most relevant EGFR exons that impact therapeutic decisions for lung cancer patients

NEW HAVEN, CT, (September 20th, 2018) – Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced today the launch of a new ICEme™ reagent using its proprietary, ultra-sensitive ICE-COLD PCR™ (ICP) technology.

The reagent provides physicians the ability to use a liquid biopsy to identify patients eligible for Tyrosine Kinase Inhibitor (TKI) therapies through analysis of tumor DNA for these critical EGFR mutations.

The presence of such mutations indicates the patient’s eligibility for various targeted therapies including TKI. This reagent complements Precipio’s previously-launched TKI-resistance detection reagent, providing the clinician with a full suite of sequential lung-cancer diagnostic tools critical to determining patient treatment.

The TKI resistance reagent was previously launched as a therapeutic monitoring reagent which includes assays for EGFR exon 20 T790M and C797S resistance mutations; these mutations indicate that lung cancer patients have developed a resistance to TKI therapies, and should be immediately moved to alternate treatments.

The new reagent enriches and detects cancer mutations within EGFR exons 18, 19, 20 & 21, and is available on qPCR and Sanger diagnostic platforms, with a level of sensitivity as low as 0.1%.

Clinical Relevance of EGFR Mutations

EGFR mutations are found in 10-15% of lung cancers1 particularly those occurring in younger patients without a smoking history. They indicate tumors that may have significant clinical response to tyrosine kinase inhibitors (TKI), a treatment that targets EGFR mutations and has shown to be extremely successful in reducing lung cancer patient’s tumor burden. Therefore, National Comprehensive Cancer Network (NCCN) guidelines2 require that all lung cancer patients are evaluated for EGFR mutations.

Mutations in EGFR exons 18, 19, 20 & 21 cover over 95% of mutations observed in lung cancer tumors3. As patients are placed on TKI therapies, studies show that over 50% of patients may develop resistance to TKI therapies4. Therefore, it is critical to monitor patients during therapy to identify resistance so therapy can be stopped, and the patient transitioned to a next-line alternate treatment. Precipio’s TKI resistance reagent detects the T790M mutation, which is commonly seen in patients that have developed resistance to those therapies.

Benefit to Lung Cancer Patients

With this information, physicians will now be able to use Precipio’s new EGFR lung cancer detection reagent to identify those patients most likely to respond to certain targeted lung cancer therapies. In addition, once those patients are on TKI therapy, physicians can follow-up by using Precipio’s TKI Resistance Lung Panel reagent for patients with resistant or recurrent disease that may demonstrate an acquired T790M mutation, where newer FDA-approved agents have been shown to be effective.

Market Opportunity

Non-Small Cell Lung Cancer (NSCLC) has a global incidence of over 1 million5 and US incidence of ~200,0006 new patients each year. Determining if patients have an EGFR mutation is critical to determining the most appropriate therapy.

The expanded EGFR reagent will also allow for the initial screening of the patient’s sample, making the market potential for Precipio’s lung cancer reagent 3-5x larger, or an estimated $500M annually. Globally, ~377,000 (approximately 30%) NSCLC patients are EGFR mutation positive, with 38,000 in the US. These patients would likely benefit from T790M and C797S resistance mutation monitoring to ensure the patient is on the most appropriate therapy.

Competitive Advantages of ICE COLD PCR

Precipio’s multiplexed ICE COLD-PCR test offers major advantages over current sequencing technologies. It delivers at least a 500-fold improvement in sensitivity compared to standard methodologies. This enables detection levels as low as 0.1% on plasma (blood) samples.

Also, its ultra-high sensitivity enables comprehensive genomic analyses using liquid instead of solid tumor biopsy, allowing a new level of treatment optimization due to the newfound ability to regularly monitor treatment responses and alter the treatment plan accordingly.

A dramatically lower cost than competing assays is an advantage critical to maximizing adoption of this platform within the cancer treatment field ensuring widespread access for cancer patients.

“The new EGFR reagent represents the completion of an end-to-end liquid biopsy solution for lung cancer patients who require both initial tumor evaluation, as well as monitoring during therapy, to ensure their treatment is most effective,” said Ilan Danieli, CEO. “With each new test we create on the ICP platform, a new segment of cancer patients may benefit from its use, increasing the revenue potential for adopters of the platform. We have strategically prioritized expansion of the menu which we expect will result in higher adoption rates by large cancer treatment centers, an increasing number of which are presently evaluating commercial utilization of ICE-COLD PCR™.”

About Precipio

Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.www.precipiodx.com.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements,” within the meaning of federal securities laws, including statements related to ICP technology, including financial projections related thereto and potential market opportunity, plans and prospects and other statements containing the words “anticipate,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “should,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company’s definitive proxy statement filed on May 29, 2018, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 and on the Annual Report on Form 10-K for the year ended December 31, 2017 as well as the Company’s prior filings and from time to time in the Company’s subsequent filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.