REVEAL GENOMICS PRESENTS THE LATEST HER2DX® DATA IN HER2+ BREAST CANCER AT SABCS 2022 - Seite 2

to paclitaxel.

The results presented at SABCS 2022 during a Spotlight Session show that HER2DX®
risk score was significantly associated with relapse-free interval despite the
low number of events in both studies. Overall, these results show that HER2DX®
can reliably identify patients who might be ideal candidates for de-escalation
of systemic therapy.

DAPHNe and GOM studies: confirming the HER2DX® pCR score

The analysis of the HER2DX® in DAPHNe and GOM studies is the result of the
agreement between REVEAL GENOMICS® and Dana-Farber Cancer Institute (US) and
Hospital Universitario Gregorio Marañón (Spain), respectively, consisting of
using the test to analyze tumor samples from 235 patients with early-stage HER2+
breast cancer from both trials.

The DAPHNe clinical trial was a single-arm prospective academic phase II trial
in which patients with treatment-naïve stage II-III HER2+ breast cancer received
a de-escalated neoadjuvant regimen of weekly paclitaxel for 12 cycles along with
trastuzumab and pertuzumab (THP) every 3 weeks for 4 cycles. The results of this
study have prompted the COMPASS-HER2-pCR study, led by ECOG-ACRIN, which aims to
recruit more than 2000 patients.

The GOM study is a prospective observational study, ongoing since 2018, of
consecutive patients with newly diagnosed stage I III HER 2 breast cancer
candidates for 6 cycles of neoadjuvant docetaxel, carboplatin and trastuzumab
(TCH) or TCH plus pertuzumab (TCHP) across 7 public hospitals in Spain.

The results presented at SABCS 2022 show that HER2DX® pCR scores were found to
strongly predict pCR in both trials, independently of known
clinical-pathological variables and intrinsic subtype. It was also observed that
the group with high pCR likelihood according to HER2DX® benefited from the
inclusion of pertuzumab to trastuzumab-based neoadjuvant chemotherapy, in
contrast to the group with low pCR. Notably, the pCR rate of the DAPHNe group of
patients with a HER2DX® high pCR likelihood HER2DX® result was 93%.

Overall, these results show that HER2DX® pCR score can reliably identify
patients who might be ideal candidates for neoadjuvant paclitaxel, trastuzumab
and pertuzumab.

About HER2DX®?

HER2DX®? is the world's first diagnostic test formulated specifically for HER2+
breast cancer. Marketed by REVEAL GENOMICS®? since January 2022, HER2DX® is a
standardized 27-gene expression test for patients with early-stage HER2+ breast
cancer.

HER2DX®? is a prognostic and predictive assay based on clinical and genomic