On January 13, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported certain unaudited preliminary performance results for the fourth quarter and full-year 2020 (Press release, Castle Biosciences, JAN 13, 2021, View Source [SID1234573965]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"At Castle, we are committed to providing innovative, clinically actionable dermatologic tests to improve patient outcomes," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "In 2020, despite the challenges presented to us all by the global pandemic, our team remained focused on this commitment and performed exceptionally.

"We delivered year-over-year volume growth in 2020 in DecisionDx-Melanoma reports, our current lead revenue driver, despite a significant reduction in melanoma diagnoses that we believe was due to COVID-19. We also expanded our skin cancer suite of products, adding two new proprietary gene expression profile tests and increasing the estimated U.S. total addressable market (TAM) of our commercially available tests to $2 billion. We expanded our body of evidence in 2020, with 11 supportive peer-reviewed articles published for our four proprietary gene expression profile tests during the year. Evidence development remains a key component of our growth strategy, supporting adoption of our tests by clinicians and reimbursement by commercial payers.

"Even in the face of COVID-19, we more than doubled our employee headcount since the beginning of 2020 through December. Additionally, we completed two equity financings, further strengthening our balance sheet, as we look to accelerate future growth through expanded support for our currently marketed tests, including further commercial team expansion in the first half of 2021, and through our pipeline development."

Fourth Quarter Ended December 31, 2020, Highlights

Delivered 5,157 total gene expression profile test reports for all four marketed tests combined in the fourth quarter of 2020:
DecisionDx-Melanoma test reports delivered in the quarter were 4,246.
DecisionDx-SCC test reports delivered in the quarter were 428.
DecisionDx DiffDx-Melanoma test orders received and reports delivered from Nov. 2 through Dec. 31, 2020, were 92 and 73, respectively.
DecisionDx-UM test reports delivered in the quarter were 410.
Medicare Administrative Contractor (MAC), Palmetto GBA MolDx, issued a final expanded local coverage determination (LCD) and an accompanying billing and coding article for the Company’s DecisionDx-Melanoma test. Noridian, the MAC that oversees Castle’s laboratory in Arizona, issued an identical LCD and billing and coding article, which became effective Dec. 6, 2020. Since the effective date of Dec. 6, 2020, more than 90% of Medicare beneficiaries whose clinicians order DecisionDx-Melanoma as part of their melanoma management plan were covered under the expanded LCD. Additionally, final 2021 Medicare rates for both DecisionDx-Melanoma and DecisionDx-UM were published on Dec. 28, 2020, on the Centers for Medicare & Medicaid Services (CMS) website.
The Company launched its DecisionDx DiffDx-Melanoma test on Nov. 2, 2020. DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions.
On Dec. 18, 2020, Castle completed its underwritten public offering of 4.6 million shares of its common stock at a public offering price of $58.00 per share. The gross proceeds to Castle from the offering before deducting the underwriting discounts and commissions and other offering expenses payable by Castle, were $266.8 million.
Year- Ended December 31, 2020, Highlights

Total gene expression profile test reports delivered in 2020 were 18,185:
DecisionDx-Melanoma test reports delivered in 2020 were 16,232. While third-party data for December is still finalizing, data through November suggests that diagnoses of melanoma were down 19% in 2020 over the prior year.
DecisionDx-SCC test orders received and reports delivered in 2020 (Aug. 31, 2020 – Dec. 31, 2020) were 562 and 485, respectively.
DecisionDx DiffDx-Melanoma test orders received and reports delivered in 2020 (Nov. 2, 2020 – Dec. 31, 2020) were 92 and 73, respectively.
DecisionDx-UM test reports delivered in 2020 were 1,395.
The Company launched its DecisionDx-SCC test on Aug. 31, 2020. DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, is designed to predict individual metastatic risk to inform risk-appropriate management.
11 peer-reviewed articles to support physician adoption and commercial payer reimbursement of Castle’s currently marketed tests were published in 2020.
Palmetto GBA MolDx, Noridian and associated Medicare Administrative Contractors (MAC) reviewed the DecisionDx-Melanoma data package as part of a reconsideration request in mid-2019 to review an expansion of coverage criteria for DecisionDx-Melanoma. LCD drafts were finalized in the second half of 2019 and effective in the fourth quarter of 2020. The Company believes that this data package demonstrating medical necessity also positively impacted reviews by commercial payers in that 288 insurance companies reviewed and approved claims for DecisionDx-Melanoma in 2020. Additionally, several regional health plans and a Blue Shield licensee have independently reviewed DecisionDx-Melanoma and have either issued or retired medical policies to support the medical necessity of DecisionDx-Melanoma.
Year-end 2020 cash and cash equivalents were approximately $410 million.
Castle Biosciences has not completed the preparation of its financial statements for the fourth quarter or full-year 2020. The preliminary, unaudited performance results presented in this press release for the quarter and year-ended December 31, 2020, are based on management’s initial review of the information presented and are subject to adjustment based on the completion of the Company’s end-of-period reporting processes and related activities, including the audit by our independent registered public accounting firm of the Company’s financial statements, as such, any financial information contained herein may differ materially from the information reflected in our financial statements as of and for the year-ended December 31, 2020. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of and for the quarter and year-ended December 31, 2020. Accordingly, undue reliance should not be placed on this preliminary information.

On January 13, 2021 HiberCell, a biotechnology company developing novel therapeutics for cancer relapse and metastasis, reported an agreement with Biodesix, Inc. (Nasdaq: BDSX) to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs (Press release, HiberCell, JAN 13, 2021, View Source [SID1234573963]). Terms of the partnership were not disclosed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Biodesix leverages multiple technologies with its proprietary artificial intelligence platform to discover, develop and commercialize diagnostic solutions for unmet clinical needs. Through this agreement, Biodesix will continue its leadership in clinical proteomics by developing a companion diagnostic to select patients for enrollment in HiberCell’s future registrational clinical trials. The ELISA test, which will be validated in Biodesix’s NYS CLEP-approved and CLIA-accredited lab, will be designed to test for Anti-β Glucan IgG Antibody (IgG ABA) expression in breast and melanoma serum samples to assess cancer patients’ eligibility for Imprime PGG therapy.

"We are pleased to partner with Biodesix to further enable our patient stratification capabilities for our lead clinical asset, Imprime PGG," said Alan C. Rigby, Ph.D., co-founder and chief executive officer of HiberCell. "We look forward to a robust collaborative effort with the Biodesix team that is initially focused on rapidly identifying patients for our Imprime PGG clinical trials, while supportive of our efforts to bring a potentially transformative portfolio of therapies to patients living with hard-to-treat recurrent metastatic disease."

"Biodesix is excited to collaborate with HiberCell across their promising portfolio," said Scott Hutton, president and chief executive officer of Biodesix. "Our leadership in clinical proteomics along with our comprehensive approach to diagnostic discovery, development and commercialization will help streamline and accelerate HiberCell’s ability to bring critical therapies to patients. Working together on a companion diagnostic for the Imprime PGG program is only touching the surface of what we can do together. This approach to identifying patients for this drug is very novel and holds tremendous promise."

On January 13, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that it has acquired a worldwide exclusive license to the proprietary TARDIS technology from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope (Press release, Exact Sciences, JAN 13, 2021, View Source [SID1234573960]). This compelling and technically distinct approach will help expand Exact Sciences’ leadership in precision oncology and offers a differentiated patient-specific solution in minimal residual disease testing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Analysis of DNA shed into a patient’s blood stream can provide a noninvasive means of detecting the presence of a tumor. Patients who have undergone initial treatment may only have small amounts of tumor DNA in their blood, which can be difficult to detect with conventional technology. TARDIS was developed to be highly sensitive and customizable for each patient, including those with only a trace amount of tumor remaining following surgery or other localized treatment that is undetectable by imaging.i

"Exact Sciences is uniquely positioned to lead cancer diagnostics with our broad foundation and the talented team that created Cologuard and Oncotype DX," said Kevin Conroy, chairman and CEO of Exact Sciences. "We’re excited to work with TGen and City of Hope to bring the incredible TARDIS technology to physicians and patients and deliver a better solution in minimal residual disease to improve cancer patient outcomes."

In a study published in Science Translational Medicine, TARDIS demonstrated high accuracy in assessing molecular response and residual disease during neoadjuvant therapy to treat breast cancer. TARDIS achieved up to 100-fold improvement beyond the current limit of circulating tumor DNA detection.i

"Blood-based diagnostics are critical to the future of cancer care, and licensing TARDIS to an industry leader like Exact Sciences speaks volumes about its potential to positively impact the field," said Jeffrey M. Trent, Ph.D., TGen president and research director. "The scale and reach Exact Sciences brings to the market means greater access — and new hope — for patients faced with a cancer diagnosis."

TGen became a part of City of Hope in 2016 to accelerate the speed at which scientists and medical staff convert research discoveries into cures for patients. City of Hope is a National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, making it a national leader in advancing research and treatment protocols.

"We are proud of the innovation driven by TGen in the development of TARDIS technology and are excited about the licensing agreement with Exact Sciences as its leadership in screening and diagnostics combined with this novel approach will address a very important clinical challenge in cancer care," said Robert Stone, president and CEO, City of Hope. "This is another example of City of Hope working with a leading organization around a joint vision to develop truly world-class solutions to transform the treatment of cancer patients."

XMS Capital is serving as financial advisor to Exact Sciences, and K&L Gates is serving as legal advisor. Citi is serving as financial advisor to TGen and City of Hope, and Jones Day is serving as legal advisor.

On January 13, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing,reported the closing of its previously announced registered direct offering with a group of institutional investors of 1,810,000 shares of common stock at a price of $8.30 per share, priced at-the-market under Nasdaq rules, resulting in total gross proceeds of approximately $15 million, before deducting the placement agent’s fees and other estimated offering expenses (Press release, Applied DNA Sciences, JAN 13, 2021, View Source [SID1234573959]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, for research and development, and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

This press release does 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On January 13, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and The University of Texas MD Anderson Cancer Center reported a strategic three-year collaboration agreement to advance combinatorial intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC) (Press release, UroGen Pharma, JAN 13, 2021, View Source [SID1234573958]). UroGen’s approach involves the local delivery of potent immunomodulators (UGN-201, a TLR 7/8 agonist and UGN-301, an anti-CTLA-4 antibody). UGN-301, an immune checkpoint inhibitor, is delivered using UroGen’s proprietary RTGel platform to increase dwell time, which has been shown to significantly improve the effectiveness of intravesical therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to enter into this collaboration with MD Anderson and its immunotherapy platform, which brings unique translational and clinical expertise in immuno-oncology," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen Pharma. "This agreement will help UroGen potentially bring next-generation immunotherapy to bladder cancer patients with a significant unmet need and limited clinical options other than bladder removal."

Under the agreement, MD Anderson and UroGen will collaborate on the design and conduct of non-clinical and clinical studies with oversight from a joint steering committee. UroGen will provide funding, developmental candidates, and other support.

UroGen’s investigational candidates, UGN-201 and UGN-301, are being developed to ablate tumors by non-surgical means in the treatment of HG-NMIBC. Non-clinical data suggest treatment with the combination of UGN-201 and an anti-CTLA4 antibody, delivered using UroGen’s proprietary RTGel platform, may result in improved survival and decreased tumor size.

"Immune checkpoint inhibitors have become important treatment options for many patients with bladder cancer, and we look forward to working with UroGen to advance new immunotherapy strategies with intravesical delivery," said James Allison, Ph.D., chair of Immunology, executive director of the immunotherapy platform and co-director of the Parker Institute for Cancer Immunotherapy at MD Anderson. "This novel delivery approach has the potential to limit the adverse events seen with systemic immunotherapy treatment while providing clinical benefit, which would represent a major advancement to patient care."