On November 19, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill (Press release, RedHill Biopharma, NOV 19, 2021, View Source [SID1234595860]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs are being offered by RedHill. The closing of the offering is expected to occur on or about November 23, 2021, subject to the satisfaction of customary closing conditions. In addition, RedHill has granted the underwriter a 30-day option to purchase up to an additional 0.7 million ADSs.

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Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.

The underwriter may offer the ADSs from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On November 18, 2021, the last sale price of the ADSs as reported on the Nasdaq Global Market was $3.88 per ADS.

RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

A preliminary prospectus supplement relating to the offering was filed with the SEC on November 18, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that RedHill has filed (or will file) with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about RedHill and the offering. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 19, 2021 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported the completion of its previously announced underwritten public offering of 12,500,000 shares of common stock at a price to the public of $5.60 per share, for gross proceeds of approximately $70.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay (Press release, ViewRay, NOV 19, 2021, View Source [SID1234595859]). All of the shares sold in the offering were sold by ViewRay. In addition, ViewRay has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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ViewRay intends to use the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, continued research and development and commercial expenses.

Piper Sandler and Stifel are acting as the joint book-running managers for the offering. Guggenheim Securities also is acting as a book-running manager for the offering. B. Riley Securities and BTIG are acting as co-managers for the offering.

A registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") and automatically became effective upon filing. This offering was made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On November 19, 2021 Ambrx Biopharma Inc., or Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics (EPBs), reported the publication of two abstract poster presentations to be conducted at the 2021 San Antonio Breast Cancer Symposium (SABCS), which is being held from December 7-10, 2021 (Press release, Ambrx, NOV 19, 2021, View Source [SID1234595858]). The abstract poster presentations will highlight clinical data from Ambrx’s ongoing ACE-Breast-03 and ACE-Breast-01 clinical trials of ARX788. The company’s ACE-Breast-01 abstract was selected as a Spotlight Poster Discussion.

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All posters will be available virtually on the SABCS website at www.SABCS.org as well as in the symposium poster hall beginning Wednesday, December 8, 2021 at 9:00 AM ET. Details on the abstracts and corresponding poster presentations are shown below.

Poster Number: OT1-02-02
Title: "A global, phase 2 study of ARX788 in patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens"
Presentation Time: December 8, 2021 at 5:00 PM CST
Session Name: Ongoing Trials Poster Session 1
Presenters: Sara Hurvitz, MD; Janice Lu, MD; Joy Yan, MD, PhD

Spotlight Poster Discussion Number: PD8-04
Poster Title: "Safety and anti-tumor activity of ARX788 in HER2-positive metastatic breast cancer patients whose disease is resistant/refractory to HER2 targeted agents (trastuzumab, ADCs, TKIs, and bispecific antibodies): ACE-Breast-01 trial results"
Presentation Time: December 9, 2021 at 7:00 AM CST
Session Name: Spotlight Poster Discussion 8
Presenters: Xichun Hu, MD; Jiang Zhang, MD

On November 19, 2021 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported the release of 9 abstracts that will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 7-10, 2021 (Press release, Puma Biotechnology, NOV 19, 2021, View Source [SID1234595856]). Abstracts are available to the public online on the SABCS website at www.sabcs.org.

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Oral Presentation:

Abstract:

GS4-10

Title:

Neratinib + fulvestrant + trastuzumab for hormone receptor-positive, HER2-mutant metastatic breast cancer and neratinib + trastuzumab for triple-negative disease: Latest updates from the SUMMIT trial

Presenter:

Komal Jhaveri, MD, FACP

Session:

Friday, Dec. 10, 11:00-11:15 a.m. CT

Poster Presentations:

Abstract:

P2-10-08

Title:

Assessment of risk factors for HER2+ breast cancer recurrence: A literature review

Presenter:

Joyce O’Shaughnessy, M.D.

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-11-02

Title:

Subsequent breast cancer among women with HER2+ disease in a large integrated healthcare system

Presenter:

Reina Haque, PhD, MPH

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-11-19

Title:

Estimating the long-term risk of recurrence in patients receiving HER2-targeted agents in HER2+ early-stage breast cancer (ESBC)

Presenter:

David Leroy Veenstra, PharmD, PhD

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-13-05

Title:

Central nervous system metastases as a site of first recurrence in adjuvant therapy trials of HER2+ early breast cancer (EBC)

Presenter:

Nancy U. Lin, MD

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P2-13-21

Title:

Improved central nervous system outcomes in patients with early-stage HER2-positive breast cancer who receive neratinib for the recommended duration: Findings from the phase 3 ExteNET trial

Presenter:

Frankie Ann Homes, MD, FACP

Session:

Poster Session 2, Wednesday, Dec. 8, 5:00-6:30 p.m. CT

Abstract:

P3-12-20

Title:

Outcomes of patients with pathologic complete response following neoadjuvant HER2-targeted therapy in patients with HER2+ early stage breast cancer

Presenter:

Joyce O’Shaughnessy, M.D.

Session:

Poster Session 3, Thursday, Dec. 9, 7:00-8:30 a.m. CT

Abstract:

P3-16-01

Title:

Population effectiveness model of the consequences of recurrence after trastuzumab emtansine (T-DM1) treatment among U.S. patients with high-risk HER2+ early-stage breast cancer (ESBC)

Presenter:

David Leroy Veenstra, PharmD, PhD

Session:

Poster Session 3, Thursday, Dec. 9, 7:00-8:30 a.m. CT

Abstract:

P5-18-02

Title:

Final findings from the CONTROL trial of diarrheal prophylaxis or neratinib dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2+ early-stage breast cancer

Presenter:

Arlene Chan, MBBS, FRACP, MMED

Session:

Poster Session 5, Friday, Dec. 10, 7:00-8:30 a.m. CT

On November 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported the publication of a study of patients with stage I-III cutaneous melanoma (Press release, Castle Biosciences, NOV 19, 2021, View Source [SID1234595855]). Data demonstrated that DecisionDx-Melanoma is a significant independent predictor of metastatic recurrence.

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DecisionDx-Melanoma is Castle’s gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. The study, titled "The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma," analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care. The study can be accessed here.

"This study reinforced one of the primary reasons why I order DecisionDx-Melanoma for my patients as soon as they receive a melanoma diagnosis," said first author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates, Portsmouth, N.H. "It’s designed to provide personalized, prognostic information that I use to determine the likelihood that the cancer will spread, which helps inform decisions for treatment to ensure the best possible outcome for each patient’s disease."

Study background and highlights:

The study’s primary purpose was to show risk stratification by DecisionDx-Melanoma in patients with stage I–III cutaneous melanoma. A secondary end point was to demonstrate the added prognostic value of DecisionDx-Melanoma when combined with complete American Joint Committee on Cancer (AJCC) staging (including SLN status) or with SLN status alone, for recurrence detection.
438 patients with stage I–III melanoma consecutively tested with DecisionDx-Melanoma were analyzed and stratified as low risk (Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B) of recurrence or metastasis.
DecisionDx-Melanoma significantly stratified five-year melanoma survival prognoses for patients, including recurrence-free survival (RFS) (p<0.001), distant metastasis-free survival (DMFS) (p<0.001) and melanoma-specific survival (MSS) (p<0.001).
Patients with a DecisionDx-Melanoma low-risk result (Class 1A) had higher five-year survival outcomes and were less likely to experience a recurrence than patients with a high-risk result (Class 2B).
Multivariable analysis showed that DecisionDx-Melanoma is a significant, independent predictor of metastatic recurrence (hazard ratio=5.38, p=0.014).
DecisionDx-Melanoma increased prognostic survival accuracy over sentinel lymph node status alone.
Consistent with previous validation and performance studies, the study demonstrated that DecisionDx-Melanoma added independent prognostic value to current staging guidelines for cutaneous melanoma to identify patients with a high and low recurrence or metastasis risk to improve patient management.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Sept. 30, 2021, DecisionDx-Melanoma has been ordered 84,195 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.