On November 24, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021 (Press release, RedHill Biopharma, NOV 24, 2021, View Source [SID1234596048]).

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The Company will host a webcast on Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021.

The webcast including slides will be broadcast live on the Company’s website, View Source, and will be available for replay for 30 days.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:
+972-3-530-8845; the access code for the call is: 9753927 .

On November 24, 2021 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications including ocular and urologic cancers, reported financial results for the third quarter ended September 30, 2021 (Press release, Aura Biosciences, NOV 24, 2021, View Source [SID1234596046]).

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"We recently completed a successful initial public offering, placing us in a solid financial position to advance our lead VDC, AU-011, through pivotal development for our first indication in the ocular oncology franchise," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are very encouraged with the final data from the Phase 1b/2 trial with intravitreal administration that was presented by Dr. Carol Shields at the AAO annual meeting last week, as well as the continued favorable safety and tolerability profile of the ongoing Phase 2 study with suprachoroidal administration. These data support our plan to move into the pivotal program in 2022 with the goal to develop the first targeted therapy for patients with indeterminate lesions and small choroidal melanoma.

Dr. Pinos continued: "We are also excited to work toward unlocking the broad oncology potential of the VDC platform and plan to initiate clinical development in non-muscle invasive bladder cancer during the second half of next year. Supporting the advancement of our programs, we have a robust balance sheet and a strong team, which we recently built out with several key additions to our management team and Board of Directors."

Recent Pipeline Developments

AU-011 is being developed for the first line treatment of indeterminate lesions and small choroidal melanoma, a life threatening and rare disease with no approved drugs. Data from two clinical trials were recently presented at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.
Final Phase 1b/2 Data with Intravitreal (IVT) Administration. Data from the completed Phase 1b/2 trial using IVT administration were presented by Dr. Carol Shields, Director, Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. The data demonstrated a statistically significant reduction in tumor growth rate (-0.483 mm/yr, p = 0.018), a 64% tumor control rate, and a visual acuity preservation rate of 71%, which is a dramatic improvement compared to the current standard of care with radiotherapy. These three endpoints have been agreed upon with FDA and will be used in the pivotal program.
Interim Phase 2 Safety Data with Suprachoroidal (SC) Administration. Preliminary results presented by Dr. Hakan Demirci, Professor of Ophthalmology at Kellogg Eye Center, University of Michigan, demonstrate a favorable safety and tolerability profile for AU-011 with SC administration. The data showed no treatment-related serious adverse events, dose limiting toxicities, or grade 3/4 adverse events. Aura plans to present 6-12 months safety and efficacy data from this trial in 2022.
Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in the second half of 2022.
Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in non-muscle invasive bladder cancer (NMIBC).
NMIBC is an area of high unmet need with no approved targeted therapies. The AU-011 mechanism of action supports the opportunity for use as a first-line treatment either following initial diagnosis and/or Bacillus Calmette-Guerin, BCG, refractory disease. The data from preclinical Investigational New Drug (IND)-enabling studies of AU-011 demonstrated robust efficacy, supporting its clinical development as a single agent or in combination with checkpoint inhibitors. The planned Phase 1a trial will evaluate the safety and early proof of mechanism in the setting, exploring local necrosis and evidence of immune activation, and Aura expects to initiate the trial in the second half of 2022.
Recent Corporate Updates

Completed Initial Public Offering (IPO). In November 2021, Aura closed a successful IPO of 6,210,000 shares of its common stock, which included the full exercise of the underwriters’ option, at a public offering price of $14.00 per share. The aggregate gross proceeds to Aura from the IPO were approximately $86.9 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Aura’s common stock commenced trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol "AURA".
Antony Mattessich Appointed to the Board of Directors in September 2021. Mr. Mattessich is currently the Chief Executive Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was Managing Director of Mundipharma International, based in Cambridge, England. Prior to his time at Mundipharma, Mr. Mattessich ran the U.S. respiratory, dermatology and pediatrics group at Novartis.
Chris Primiano, J.D., Appointed Chief Business Officer in September 2021. Mr. Primiano joined Aura from Karyopharm Therapeutics Inc., where he most recently served as Executive Vice President, Chief Business Officer, General Counsel and Secretary. Mr. Primiano played an important role in transitioning Karyopharm Therapeutics Inc. from 40 employees in a preclinical and early clinical development setting to 400 employees, commercializing XPOVIO (selinexor) across multiple indications.
Third Quarter 2021 Financial Results

As of September 30, 2021, Aura had cash and cash equivalents totaling $81.8 million. Aura raised $86.9 million in gross proceeds from the IPO. Aura believes its current cash and cash equivalents are sufficient to fund the Company’s operations into 2024.
Research and development expenses increased to $6.4 million for the three months ended September 30, 2021 from $2.9 million for the three months ended September 30, 2020, primarily due to progression of clinical trials and ongoing manufacturing development costs for AU-011. In addition, research and development expenses related to personnel increased from growing headcount due to the progression of clinical trials.
General and administrative expenses increased to $2.5 million for the three months ended September 30, 2021 from $0.8 million for the three months ended September 30, 2020. General and administrative expenses include $0.4 million and $0.1 million of stock-based compensation for the three months ended September 30, 2021 and 2020, respectively. The increase was primarily related to an increase in personnel expenses due to an increase in headcount, as well as general increases in audit, legal, consulting and facilities expenses in anticipation of becoming a public company.
Net loss for the three months ended September 30, 2021, was $8.8 million, compared to $3.6 million for the three months ended September 30, 2020.

On November 24, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management decisions and improve patient outcomes, reported oral presentations on its DecisionDx gene expression profile (GEP) tests for skin cancer at the American Society for Dermatologic Surgery (ASDS) 2021 Annual Meeting, held Nov. 19-21, 2021 (Press release, Castle Biosciences, NOV 24, 2021, View Source [SID1234596045]).

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"We are excited to share data further reinforcing the clinical utility of our GEP tests with leading experts and health care professionals," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our DecisionDx tests complement dermatology clinicians’ arsenal of tools and help ensure the best possible outcomes for their patients. The clinically actionable information that our tests provide can help clinicians make informed and personalized treatment decisions for each patient based on their unique biology."

DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s risk-stratification GEP test that is designed to predict 5-year risk of metastasis, as well as metastasis to the sentinel lymph node (SLN), independent of traditional staging factors. The test’s Integrated Test Result (ITR) includes the traditional class designation of lowest risk (Class 1A), increased risk (Class 1B/2A) or highest risk (Class 2B), as well as a more precise risk prediction for both SLN positivity and risk of recurrence, distant metastasis and melanoma survival in patients with stage I, II or III melanoma through the i31- GEP algorithms (i31-SLNB and i31-Risk of Recurrence (ROR)). The i31-SLNB and i31-ROR are distinct, independently validated algorithms that integrate clinicopathologic features with the DecisionDx-Melanoma score.

Nicholas Taylor, M.D., Ph.D. presented data on DecisionDx-Melanoma through an oral presentation titled "Integrated clinicopathologic data and gene expression profile predict sentinel lymph node positivity and recurrence-free and distant metastasis-free survival in cutaneous melanoma."

Study background and findings:

The study’s objective was to understand how integrating gene expression profiling with clinical and pathologic features can improve personalized medicine.
DecisionDx-Melanoma’s continuous score was integrated with clinical and pathologic factors using the proprietary i31-SLNB and i31-ROR algorithms to predict the likelihood of SLN positivity, recurrence-free survival (RFS) and distant metastasis-free survival (DMFS).
The study results showed that patients with a negative SLN but a high-risk DecisionDx-Melanoma result for RFS had outcomes similar to patients with a positive SLN. In contrast, patients with a positive SLN but a low-risk DecisionDx-Melanoma result had outcomes similar to patients with a negative SLN.
Overall, the study demonstrated that integrating the DecisionDx-Melanoma continuous risk score with a patient’s clinicopathologic factors can identify patients at the highest and lowest risk for recurrence or metastasis, thereby informing individualized management plans for patients with melanoma.
DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) having one or more risk factors.

An oral presentation on DecisionDx-SCC titled "Incorporation of a prognostic 40-gene expression profile (40-GEP) test into risk assessment of cutaneous squamous cell carcinoma (SCC) in a Mohs micrographic surgery (MMS) treated population" was presented by Sarah T. Arron, M.D., Ph.D.

Study background and findings:

​Mohs micrographic surgery (MMS) is the current standard of care for SCC and is an effective technique for treating high-risk SCCs.
The objective of the study was to evaluate the potential of DecisionDx-SCC to stratify metastatic risk within a high-risk SCC population treated by MMS, representing patients with the highest likelihood for complete tumor resection.
The study analyzed 328 patients with National Comprehensive Cancer Network (NCCN) high-risk tumors who were treated with MMS with confirmed clean margins.
Patients receiving a DecisionDx-SCC Class 2B result had a high metastasis rate of 58.8%, suggesting that this set of patients may benefit from additional adjuvant treatment after MMS.
Univariate and multivariate Cox regression analysis showed that DecisionDx-SCC provides independent prognostication for metastasis (hazard ratio of 15.12 and a p value of <0.001 for multivariate Class 2B results) when compared to traditional high-risk clinicopathological factors, such as presence of perineural invasion, poor differentiation and deep invasion.
The specificity and positive predictive value (PPV) of a high-risk Class 2B DecisionDx-SCC result were higher when compared to American Joint Committee on Cancer Staging Manual Eighth Edition (AJCC8) (T3/T4 tumors) and Brigham and Women’s Hospital (BWH) (T2b/T3 tumors), demonstrating that DecisionDx-SCC accurately identified the patients at highest risk for a poor outcome, while maintaining a similar negative predictive value (NPV) and sensitivity.
Overall, the study data showed that DecisionDx-SCC demonstrated significant risk stratification for MMS-treated patients with confirmed complete margin clearance.
Statistically significant survival analyses, adjusted for clinicopathological factors, and improved accuracy metrics compared to those of current staging systems, indicate that DecisionDx-SCC adds value to current methods of risk assessment.
Incorporating DecisionDx-SCC into post-MMS SCC patient risk assessment could facilitate more personalized and improved patient management and disease-related outcomes.
Comprehensive Diagnostic Offering:

Castle’s Comprehensive Diagnostic Offering (CDO) leverages the strengths of both myPath Melanoma and DecisionDx DiffDx-Melanoma, two GEP tests designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions.

"A comprehensive diagnostic offering (CDO) increases rates of actionable results of the 23- and 35-gene expression profile test for use as ancillary diagnostics for difficult-to-diagnose melanocytic lesions" was presented as part of an industry-sponsored session by Matthew Goldberg, M.D., medical director of Castle Biosciences.

Background and conclusions:

Diagnostic ambiguity of melanocytic lesions can lead to clinical management uncertainty and complex conversations with patients regarding treatment and follow-up care.
Castle’s Comprehensive Diagnostic Offering (CDO) is designed to leverage the strengths of both myPath Melanoma and DecisionDx DiffDx-Melanoma to report actionable results of benign gene expression profile or malignant gene expression profile for the greatest number of lesions submitted for testing.
Castle’s CDO workflow significantly improved the reporting of clinically actionable results (benign or malignant) from ~77% with myPath alone, to more than 98% when run as part of the diagnostic workflow with DecisionDx DiffDx-Melanoma.
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.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

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

About Castle Biosciences’ Comprehensive Diagnostic Offering for Difficult-to-Diagnose Melanocytic Lesions

Castle Biosciences’ comprehensive diagnostic offering leverages the strengths of myPath Melanoma and DecisionDx DiffDx-Melanoma. These gene expression profile tests are designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, myPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

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

On November 24, 2021 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) reported their agreement with Molecular Targeting Technologies, Inc. (MTTI), a clinical stage biotech company focused on developing innovative therapies for rare cancers, for the supply of the medical radioisotope no-carrier-added 177Lu (n.c.a. 177Lu) (Press release, Molecular Targeting Technologies, NOV 24, 2021, View Source [SID1234596044]).

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Eczacıbaşı-Monrol entered the theranostic market in 2019 as one of the few producers of Lutetium-177 worldwide and since then has provided an uninterrupted supply of this critical product to patients in many countries. In line with its mission to improve the quality of life of cancer patients globally, the company is establishing strategic partnerships with international pharmaceutical companies and constructing a new production facility compliant with FDA 21 CFR Part 211 quality standards that will have an annual capacity of 60 thousand doses. Thanks to its location close to Istanbul’s transportation hub, the new facility will benefit from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide.

Aydin Küçük, General Manager of Eczacıbaşı-Monrol, noted that n.c.a.177Lu contributes to the company’s mission of adding value to human life with leading and innovative approaches in the diagnosis and treatment of critical diseases and added, "To support our growth in this field, we’re establishing a new GMP certified facility exclusively for theranostic R&D and production with a new technology that will enable us to maximize our supply of high-quality Lutetium. Sustainability and innovation are two of our core values, and we strive for continuous improvement in our operations and products while trying to serve patients all around the world."

Molecular Targeting Technologies, Inc. (MTTI) CEO, Chris Pak said, " We’ve identified a timely and sustainable supply of a key therapeutic ingredient needed for the development and launch of our lead asset 177Lu-EBTATE and other EB platform technologies. We are excited to start

this collaboration and build what promises to be a great relationship with a reliable and trusted radioisotope supply partner like Eczacıbaşı-Monrol for the supply of n.c.a.177Lu."

On November 24, 2021 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that John P. Butler, Chief Executive Officer, and David A. Spellman, Chief Financial Officer, will participate in the following investor conferences (Press release, Akebia, NOV 24, 2021, View Source [SID1234596042]):

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Piper Sandler 33rd Annual Virtual Healthcare Conference
November 29 – December 2, 2021
John Butler will participate in a virtual fireside chat, which will be available on the conference site prior to the virtual event.

4th Annual Evercore ISI HealthCONx Conference
November 30 – December 2, 2021
John Butler will participate in a virtual fireside chat, which will be presented on Tuesday, November 30 at 4:45 on the conference site.

Where applicable, webcasts of Akebia’s fireside chats will be made available on the Investors section of the Company’s website at View Source