On May 19, 2020 BostonGene Corporation, a biomedical software company focused on defining optimal, precision medicine-based therapies for cancer patients, reported that, as a result of its strategic collaborations, seven abstracts have been accepted to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, BostonGene, MAY 19, 2020, View Source [SID1234558290]). All abstracts to be published in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

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"We are honored to have multiple abstracts accepted by ASCO (Free ASCO Whitepaper) 2020. The studies demonstrate the clinical utility of BostonGene‘s advanced precision medicine capabilities and our commitment to transform the lives of cancer patients," said Andrew Feinberg, President & CEO at BostonGene.

Details of abstract presentations are as follows:

1.Abstract Number: 8055*

Title: "Multi-omics analysis of mantle cell lymphoma reveals an immune-cold tumor microenvironment associated with ibrutinib resistance"

Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Presenter: Krystle Nomie, PhD, BostonGene

Poster: 388

Tumor-immune molecular programs were characterized from over 200 mantle cell lymphoma samples and correlated with response to ibrutinib.

Research conducted with The University of Texas MD Anderson Cancer Center

2.Abstract Number: 6561*

Title: "Immune functional portraits of head and neck cancer using next generation sequencing"

Session: Head and Neck Cancer

Presenter: Susan Raju Paul, MBBS, Vaccine and Immunotherapy Center, Massachusetts General Hospital

Poster: 222

BostonGene’s comprehensive, integrated analysis of WES and RNAseq was used to characterize the cellular composition and functional state of over 1,400 head and neck tumors and their tumor microenvironment.

Research conducted with Massachusetts General Hospital

3.Abstract Number: 8054*

Title: "Identification of Predicted Neoantigen Vaccine Candidates in Follicular Lymphoma Patients"

Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Presenter: Cody Ramirez at Washington University in St Louis

Poster: 387

Tumor-specific mutant antigens (TSMAs) that can be targeted by vaccination were studied in follicular lymphoma patients and led to a first-in-human pilot trial of a personalized TSMA vaccine combined with immunotherapy.

Research conducted with Washington University in St Louis

4.Abstract Number: e20065

Title: "Correlation of PI3K upregulation with NOTCH2 mutations in ibrutinib-resistant mantle cell lymphoma"

First Author: Krystle Nomie, PhD, BostonGene

Research conducted with The University of Texas MD Anderson Cancer Center

5.Abstract Number: e21026

Title: "Non-small cell lung cancer: Analysis using mass cytometry and next generation sequencing reveals new opportunities for the development of personalized therapies"

First Author: Susan Raju Paul, MBBS, Vaccine and Immunotherapy Center, Massachusetts General Hospital

Research conducted with Massachusetts General Hospital

6.Abstract Number: e17106

Title: "Integrated single-cell spatial multi-omics of intratumor heterogeneity in renal cell carcinoma"

First Author: James Hsieh, MD, PhD at Washington University in St. Louis

Research conducted with Washington University in St Louis

7.Abstract Number: e17506

Title: "Integrated-omics of MRI-visible and -invisible prostate cancer identifies molecular correlations with clinical outcome"

First Author: Eric H. Kim, MD at Washington University in St. Louis

Research conducted with Washington University in St Louis

*Abstracts to be presented as posters at the 2020 ASCO (Free ASCO Whitepaper) Annual Virtual Meeting from May 29-31, 2020

On May 19, 2020 Tyme Technologies, Inc. (NASDAQ:TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that leadership will participate at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 (Press release, TYME, MAY 19, 2020, View Source [SID1234558289]). The Company will present its corporate overview for 2020 with a special focus on multiple growth opportunities driven by advances in the science of cancer metabolism, pivotal trials in pancreatic cancer, clinical trial in ultra-rare metastatic sarcoma and expanding clinical plans for its lead candidate SM-88 (racemetyrosine) in pancreatic, prostate, breast and hematological cancers.

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Event: Jefferies Virtual Healthcare Conference
Presentation Date: Wednesday, June 3, 2020
Presentation Time: 9:30 AM EST

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com. There are no planned webcasts for this event.

On May 19, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) reported the closing on May 13, 2020 of the final tranche of a previously announced private placement. With this closing, MedX has raised gross proceeds totalling $3,112,753 since January 30, 2020 (Press release, MedX Health, MAY 19, 2020, View Source [SID1234558288]). "This marks the successful achievement, indeed over-achievement of the target, set in January 2020 to raise $3.0 million to finance the development and expansion of MedX’s complete end-to-end telehealth solution focused on Dermatology. The funding will allow MedX to hire key sales and operational personnel required to expand into new marketplaces, in particular in Latin America and the USA where the Company is anticipating rapid growth," stated Scott Spearn, CEO of MedX.

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MedX announced that further to the Conditional Approval from the TSX Venture Exchange for a non-brokered Private Placement to accredited investors of up to 25,000,000 units at $0.12 per unit ("Unit"), to raise up to $3,000,000 that was announced on March 6, 2020, the closing of a final tranche of that placement has taken place on May 13, 2020, for a total of 4,887,466 units, raising a total of $586,496. Each Unit is comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. The securities issued will be restricted from trading for four months from their respective dates of issue.

In connection with this non-brokered private placement, 324,000 agent’s warrants ("Agent’s Warrant(s)"), as described below, were also issued. Each Agent’s Warrant, which is non-transferable, is exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the date of issue. In connection with the May 13, 2020 Closing, total cash commissions of $78,640 were paid.

On May 19, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an intended use survey for DecisionDx-SCC, its prognostic test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) (Press release, Castle Biosciences, MAY 19, 2020, View Source [SID1234558287]). The test is expected to be launched commercially in the third quarter of 2020.

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The article titled, "Impact of a prognostic 40-gene expression profiling test on clinical management decisions for high-risk cutaneous squamous cell carcinoma," was published in the peer-reviewed journal, Current Medical Research and Opinion (CMRO).

Results of the study demonstrate that integration of DecisionDx-SCC (40-gene expression profile test) results impacted management decisions in a significant and risk-appropriate manner for high-risk SCC patient scenarios, while remaining aligned with national guidelines for patient management.

"It is critical that management and follow-up recommendations for patients diagnosed with high-risk cutaneous squamous cell carcinoma are tailored to individual risk, yet current staging methods are often unable to precisely stratify different risk groups that may have markedly different outcomes," said principal investigator Darrell Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. "These results demonstrate that information on tumor biology can impact clinical decisions in a significant, risk-appropriate manner."

Disease and Study Background

Approximately 1 million patients are diagnosed with SCC of the skin in the U.S. each year, and the incidence continues to grow; while the majority of patients have a favorable prognosis, approximately 200,000 patients are identified as high risk.
National Comprehensive Cancer Network (NCCN) guidelines for SCC define treatment pathways based on risk of local recurrence or metastasis. For SCC, there are two clinicopathologically defined categories: low risk and high risk. NCCN defines high risk as SCC patients with one or more of several high-risk clinicopathologic features.
DecisionDx-SCC stratifies patients into three categories based on risk of metastasis: Class 1 (low-risk), Class 2A (high-risk) and Class 2B (highest-risk).The study objective was to determine the impact of DecisionDx-SCC test results on clinician management decisions and how their choices would align with an NCCN compliant, risk-directed management plan for high-risk SCC.
162 clinicians attending a national dermatology conference were presented with DecisionDx-SCC test validation data. They were then asked to rate clinicopathological features and DecisionDx-SCC test results to assess their opinion of how concerning each is to SCC prognosis. When presented with vignettes describing patients with NCCN-defined high-risk features, clinicians were asked to document their treatment plan pre-test (without DecisionDx-SCC results), then, post-test (with DecisionDx-SCC Class 1, 2A, or 2B results) methodology along with corresponding metastasis rates for each test group. Assessed treatment plan modalities included follow-up schedule, sentinel lymph node biopsy, nodal imaging, adjuvant radiation and adjuvant chemotherapy.
Study Findings

When comparing DecisionDx-SCC risk classes with clinicopathologic risk factors, Class 2B DecisionDx-SCC result, perineural invasion, immunosuppression, invasion beyond subcutaneous fat, and tumor diameter >1cm on the scalp were identified as the features most highly associated with risk of metastasis.
Adding a DecisionDx-SCC low-risk Class 1 result to clinicopathologic information led to an overall reduction in treatment plan modality intensity by more than 60% when compared to clinicopathological features alone.
Adding a Decision-SCC Class 2B test result to clinicopathologic information led to an overall escalation in treatment plan modality intensity by more than 90% when compared to clinicopathological features alone.
More than 95% of the management recommendations were in a risk appropriate direction compared to the DecisionDx-SCC class result, and all changes were within established NCCN-guidelines for patient management.
DecisionDx-SCC is the second skin cancer test discovered, developed and validated by Castle Biosciences.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (SCC) is one of the most common cancers. Approximately 1 million patients are diagnosed with SCC each year in the U.S. While the majority of patients have a favorable prognosis, approximately 200,000 patients are identified as high risk. National guidelines provide for broad, aggressive treatment plan recommendations relative to low-risk patients. Traditional clinicopathologic based risk-factor staging systems suffer from low positive predictive value; meaning many more patients are classified as high risk than actually develop metastatic disease. This may lead to over- and under-treatment of a substantial number of cutaneous SCC patients. To address this clinical need, Castle Biosciences has developed a gene expression profile test designed to improve upon current staging systems and identify patients with cutaneous SCC at high risk for metastasis, in order to enable more informed, objective clinical decisions regarding adjuvant therapy and other management options.

On May 19, 2020 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported the pricing of its underwritten public offering of 9,433,963 shares of its common stock at a price to the public of $13.25 per share and the pricing of $200.0 million aggregate principal amount of its 5.00% convertible senior notes due 2027 (Press release, Gossamer Bio, MAY 19, 2020, View Source [SID1234558286]). The aggregate gross proceeds to Gossamer from the offerings, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $325.0 million.

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Gossamer also granted to the underwriters in the common stock offering a 30-day option to purchase up to an additional 1,415,094 shares of its common stock on the same terms and conditions and to the underwriters in the convertible senior notes offering a 13-day option to purchase up to an additional $30.0 million aggregate principal amount of the notes on the same terms and conditions solely to cover over-allotments.

The notes will be senior, unsecured obligations of Gossamer and will accrue interest at a rate of 5.00% per annum, payable semi-annually in arrears on June 1 and December 1 of each year. The notes will mature on June 1, 2027 unless earlier repurchased, redeemed or converted. Before March 1, 2027, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after March 1, 2027, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading day immediately before the maturity date. Gossamer will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Gossamer’s election. The initial conversion rate is 61.6095 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $16.23 per share of common stock. The initial conversion price represents a premium of approximately 22.50% over the public offering price per share of common stock in the common stock offering. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.

The notes will be redeemable, in whole or in part, for cash at Gossamer’s option at any time, and from time to time, on or after June 6, 2024 and on or before the 50th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Gossamer’s common stock exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading date immediately preceding the date on which Gossamer provides notice of redemption, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date on which Gossamer provides the related notice of redemption.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then noteholders may require Gossamer to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

The offerings are expected to close on May 21, 2020, subject to customary closing conditions. The closing of each offering is not contingent on the closing of the other offering.

Gossamer intends to use the combined net proceeds from the offerings to fund research and development of its product candidates and development programs and for working capital and general corporate purposes.

BofA Securities and SVB Leerink are acting as joint book-running managers for the common stock offering. Evercore ISI, Barclays and Cantor are also acting as book-running managers for the common stock offering.

BofA Securities, SVB Leerink and Piper Sandler are acting as joint book-running managers for the convertible senior notes offering. SMBC is acting as co-manager for the convertible senior notes offering.

The securities described above are being offered by Gossamer pursuant to a shelf registration statement filed by Gossamer with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. Each offering is being made only by means of a separate prospectus supplement and the related prospectus relating to such offering that will be filed with the SEC. Copies of the applicable prospectus supplement and related prospectus relating to each offering may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected] or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; or, with respect to the convertible senior notes offering, from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 1-800-747-3924 or by email at [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will 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.