Entry into a Material Definitive Agreement

On October 17, 2019 OncoCyte reported that it has entered into a First Amendment to Loan and Security Agreement (the "Amended Loan Agreement") with Silicon Valley Bank (the "Bank") pursuant to which Oncocyte obtained a new $3 million secured credit facility ("Tranche 1"), a portion of which was used to repay the remaining balance of approximately $400,000 on outstanding loans from the Bank, plus a final payment of $116,000, under the February 21, 2017 Loan Agreement with the Bank (Filing, 8-K, Oncocyte, OCT 17, 2019, View Source [SID1234551120]). The credit line under the Amended Loan Agreement may be increased by an additional $2 million ("Tranche 2") if OncoCyte obtains at least $20 million of additional equity capital, as was the case with the original Loan Agreement, and a positive final coverage determination is received from the Centers for Medicate and Medicaid Services for the Razor lung cancer test at a specified minimum price point per test (the "Tranche 2 Milestone"), and OncoCyte is not in default under the Amended Loan Agreement.

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Payments of interest only on the principal balance will be due monthly from the draw date through March 31, 2020 followed by 24 monthly payments of principal and interest, provided, however, that if the Tranche 2 Milestone is achieved the interest only payment period will be extended through September 30, 2020 followed by 18 equal monthly payments of principal plus interest. The outstanding principal balance of the loan will bear interest at a stated floating annual interest equal to (a) the greater of 0.75% above the prime rate or 4.25% for Tranche 1 loans, or (b) the greater of the prime rate or 5% per annum for Tranche 2 loans.

The principal amount of all loans plus accrued interest will be due and payable to the Bank at maturity on March 31, 2022. At maturity, OncoCyte will also pay the Bank an additional final payment fee of $200,000. Any amounts borrowed and repaid may not be reborrowed.

OncoCyte may prepay in full the outstanding principal balance at any time, subject to a prepayment fee equal to 3.0% of the outstanding principal balance if prepaid within one year after October 17, 2019, 2.0% of the outstanding principal balance if prepaid more than one year but less than two years after October 17, 2019, or 1.0% of the outstanding principal balance if prepaid two years or more after October 17, 2019.

The outstanding principal amount of the loan, with interest accrued, the final payment fee, and the prepayment fee may become due and payable prior to the applicable maturity date if an "Event of Default" as defined in the Amended Loan Agreement occurs and is not cured within any applicable cure period. An Event of Default includes, among other events, failure to pay interest and principal when due, material adverse changes, which include a material adverse change in OncoCyte’s business, operations, or condition (financial or otherwise), failure to provide the bank with timely financial statements and filings with the Securities and Exchange Commission, as required, legal judgments or pending or threatened legal actions of $50,000 or more, insolvency, and delisting from the NYSE American. OncoCyte’s obligations under the Amended Loan Agreement are collateralized by substantially all of its assets other than intellectual property such as patents and trade secrets that OncoCyte owns.

On October 17, 2019 in conjunction with Tranche 1 becoming available under the Amended Loan Agreement, OncoCyte issued a common stock purchase warrant to the Bank (the "Bank Warrant") entitling the Bank to purchase 98,574 shares of OncoCyte common stock at the initial Warrant Price of $1.69 per share through October 17, 2029. The number of shares of common stock issuable upon the exercise of the Bank Warrant will increase on the date of each draw, if any, on Tranche 2. The number of additional shares of common stock issuable upon the exercise of the Bank Warrant will be equal to 0.02% of OncoCyte’s fully diluted equity outstanding for each $1 million draw under Tranche 2. The Warrant Price for Tranche 2 warrant shares will be determined upon each draw of Tranche 2 funds and will be closing price of OncoCyte common stock on the NYSE American or other applicable market on the date immediately before the applicable date on which OncoCyte borrows funds under Tranche 2. The Bank may elect to exercise the Bank Warrant on a "cashless exercise" basis and receive a number of shares determined by multiplying the number of shares for which the Bank Warrant is being exercised by (A) the excess of the fair market value of the common stock over the applicable Warrant Price, divided by (B) the fair market value of the common stock. The fair market value of the common stock will be last closing or sale price on a national securities exchange, interdealer quotation system, or over-the-counter market.

SurgiMab Recruits First US Patient in Pivotal Phase 3 Trial Evaluating SGM-101, a Novel Fluorescent Tumor-specific Antibody, for the Improvement of Surgical Outcomes in Colorectal Cancer Patients

On October 17, 2019 SurgiMab, a late-stage biotechnology company pioneering a new antibody-based fluorescence-guided approach with the aim to improve cancer surgery and clinical outcomes for patients, reported that the first US patient has been recruited into its on-going pivotal Phase 3 clinical trial evaluating its investigational imaging agent SGM-101 in patients undergoing colorectal cancer (CRC) surgery (Press release, Surgimab, OCT 17, 2019, View Source [SID1234542349]).

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The randomized Phase 3 trial, designed following discussions with the FDA and other regulators, aims to enroll 300 CRC patients in ten clinical centers in Europe and the US. The trial will assess the safety and clinical benefit of using fluorescence-guided surgery (FGS) with SGM-101 as an intraoperative imaging agent to better identify cancer lesions during the surgical procedure. Patients are injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. Preliminary clinical data from the Phase 3 trial is expected in 2020. (ClinicalTrials.gov Identifier: NCT03659448)

SGM-101 is a tumor-specific antibody conjugated to a dye (fluorophore) that fluoresces under near-infra-red light; it selectively targets a marker on the cancer cell surface known as carcinoembryonic antigen (CEA), which is overexpressed by more than 95% of colorectal cancer cells. SGM-101 is being developed to provide cancer surgeons with a novel intraoperative imaging tool designed to improve the visualization of tumor tissues overexpressing CEA in real-time during surgery. The aim of the study is to demonstrate that SGM-101 could be used to enable surgeons to more clearly delineate the margin between tumor tissue and healthy tissue. If this is the case, it could allow a more accurate and complete resection of tumor tissue beyond what can currently be achieved with standard procedures. The Phase 3 trial is also seeking to determine if the use of SGM-101 could minimize or prevent removal of healthy tissue adjacent to tumor cells in order to better preserve functional outcomes.

SurgiMab is advancing SGM-101 into a pivotal Phase 3 trial based on compelling results from a Phase 2 study (n=75) in which residual and otherwise invisible tumor tissue was detected using SGM-101 during FGS. The Phase 2 study, published in The Lancet Gastroenterology & Hepatology[1], has shown that the use of SGM-101 during surgery leads to a modification of surgery in 35% of patients with recurrent or peritoneal metastases of CRC by allowing either more aggressive resection of tumor tissue or by preserving healthy tissue.

Dr Françoise Cailler, SurgiMab’s CEO, commented, "We are delighted to have started recruiting US patients into our pivotal Phase 3 study testing SGM-101 as a novel intraoperative imaging tool in CRC surgery. If this Phase 3 trial successfully demonstrates that the use of SGM-101 improves tumor resection, we believe that this could provide a new approach for the close to 150,000 patients diagnosed with CRC every year in the United States, most of whom undergo surgery. We look forward to reporting the preliminary data from our Phase 3 study in 2020."

Participating centers in the US in the Phase 3 study include:

Cleveland Clinic Florida, Weston, FL
Massachusetts General Hospital , Boston, MA
Moores Cancer Center – UC San Diego Health, La Jolla, CA
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA

Kymera Therapeutics to Present Preclinical Data Demonstrating the Potency and Antitumor Activity of a Selective STAT3 Degrader at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 17, 2019 Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to discover breakthrough medicines for patients, reported the company will present preclinical data showing the discovery and characterization of novel, selective, and potent degraders of STAT3, a transcriptional regulator linked to numerous cancers and other diseases (Press release, Kymera Therapeutics, OCT 17, 2019, View Source [SID1234542348]). Data will be shared during a poster presentation (Abstract #C054) at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston on Tuesday, October 29 at 12:30 PM EST.

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STAT3 is an oncogenic transcription factor that is regulated by multiple signaling events including the IL-6-JAK pathway and growth factor receptors. Activating mutations and aberrant activation of STAT3 have been directly linked to the promotion of cancer cell survival and proliferation and immune evasion, making it a highly attractive target for hematologic malignancies and solid tumors.

"STAT3 has historically been considered an ‘undruggable’ transcription factor. Over the past few decades, some of the key challenges for this target have been the lack of small molecule binders, additional functions beyond transcriptional regulation, and sequence homology with other SH2 domain-containing STAT family members," said Nello Mainolfi, PhD, Founder, President & CSO of Kymera Therapeutics. "Using our drug discovery engine, especially our understanding of ternary complex structure and function, we rationally designed specific STAT3 degraders with excellent in vivo properties. Our data using these degraders have shown disruption of signaling downstream of STAT3 and promising antitumor activity in multiple cancer models, supporting the transformative therapeutic potential of this modality. With these unique molecules we are expanding the understanding of the biological impact of STAT3 degradation in tumor and immune contexts."

AACR-NCI-EORTC Study Highlights
ABSTRACT #C054, "Discovery of KYM-003, a Potent and Selective STAT3 Degrader with Anti-Tumor Activity in Heme Malignancies," presented by Fred Csibi, Associate Director, Oncology Biology at Kymera Therapeutics.
in vitro

KYM-003 cooperatively formed a high-affinity STAT3-KYM003-E3 ligase ternary complex.
KYM-003 potently induced ubiquitination of endogenous STAT3.
KYM003-induced degradation was highly selective for STAT3 versus >10,000 other detected proteins (including all other STAT family members) in tumor cell lines and hPBMCs.
KYM003-induced degradation of STAT3 resulted in downregulation of STAT3 target-gene expression, including the PIM1 oncogene.
in vivo

Total STAT3 levels in tumors were reduced by >90% for at least 24 hours after a single dose of KYM-003.
Repeated dosing of KYM-003 showed dose-dependent antitumor activity in xenograft models of heme malignancies with good tolerability.

Accelerate Diagnostics Schedules Call to Review Third Quarter 2019 Results

On October 17, 2019 Accelerate Diagnostics, Inc. (NASDAQ: AXDX) reported that it will report financial results for the third quarter of 2019 after the market close on Thursday, November 7, 2019 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, OCT 17, 2019, View Source [SID1234542347]). The company’s management will host a conference call at 4:30 p.m. ET that same day to review the results.

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Listen to the audio webcast online by visiting ir.axdx.com and selecting the event. A replay of the audio webcast will be available until November 28, 2019.

To listen by phone, dial +1.877.883.0383 and enter the conference ID: 2508360

International participants may dial +1.412.902.6506. Please dial in 10-15 minutes prior to the start of the conference. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using the replay code 10136055 until November 28, 2019.

Nuvo Pharmaceuticals™ Announces Third Quarter 2019 Results Release Date and Conference Call Details

On October 17, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported it intends to release its third quarter 2019 financial results before markets open on Thursday, October 31, 2019 (Press release, Nuvo Pharmaceuticals, OCT 17, 2019, View Source [SID1234542346]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Company will subsequently hold a conference call that same day, Thursday, October 31, 2019 at 8:30 a.m. ET, hosted by Jesse Ledger, Nuvo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

CONFERENCE CALL DETAILS

DATE:

Thursday, October 31, 2019

TIME:

8:30 a.m. ET

DIAL-IN NUMBER:

416 764 8688 or 1 888 390 0546

TAPED REPLAY:

416 764 8677 or 1 888 390 0541 / REPLAY PASSCODE: 072242 #

The audio webcast can be accessed at:

View Source