On November 1, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the Phase II diagnostic 64Cu SAR-Bombesin trial (BOP) for patients with prostate cancer has reached the fifty percent recruitment milestone, with 15 out of 30 participants enrolled and imaged (Press release, Clarity Pharmaceuticals, NOV 1, 2022, View Source [SID1234622715]).

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Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the BOP trial, commented, "We are very excited with the fast pace of recruitment into the BOP trial. We dosed the first patient in mid-September and have reached a 50% recruitment milestone less than 2 months later. The data we are generating will help to explore and validate the clinical benefits of the SAR-Bombesin product. We look forward to recruiting the remaining 15 patients in the trial and analysing the study results.

"We believe SAR-Bombesin will play a role in the identification of disease that is not observed with conventional imaging or PSMA-PET. This could ultimately lead to more effective treatments for this large patient population where unfortunately, very few treatment options are available at present."

BOP (Copper-64 SAR Bombesin in Prostate Specific Membrane Antigen (PSMA) negative Prostate Cancer) is a Phase II investigator-initiated trial (IIT) in up to 30 patients led by Prof Louise Emmett at St Vincent’s Hospital, Sydney. The BOP trial is assessing the safety of 64Cu-SAR-Bombesin as well as looking at the diagnostic potential across two different groups of men:

Participants with suspected biochemical recurrence (BCR) of their prostate cancer who have negative PSMA positron emission tomography (PET) imaging scans or low PSMA expression disease.
Participants with metastatic castrate resistant prostate cancer (mCRPC) who are not eligible for PSMA therapy.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The rapid progress of the BOP IIT, led by Prof Emmett and her team at St Vincent’s Hospital, is testament to the hard work and dedication to our mutual goal of improving treatment outcomes for people with cancer. We are motivated and driven by the progress on our collaboration as it has already resulted in improvements to the management of the disease for patients with PSMA-negative prostate cancer.

"The BOP trial builds on the data Prof Emmett’s team generated in PSMA-negative prostate cancer patients imaged under the Therapeutic Goods Administration Special Access Scheme, as well as from the pilot diagnostic trial investigating SAR-Bombesin in breast cancer patients. The data indicates potential utility of the product as a theranostic agent. As such, Clarity plans to progress the therapy under an Investigational New Drug application with the US Food and Drug Administration for the commencement of a theranostic trial with SAR-Bombesin in the US. We believe SAR-Bombesin has the potential to provide large patient populations with accurate and precise detection and treatment of cancers."

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)1-5. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide6. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease7.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative8-11. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.

On November 1, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in Wonderland: Miami hosted by Microdose to be held at the Mana Wynwood Convention Center in Miami, FL on November 3-5, 2022 (Press release, Enveric Biosciences, NOV 1, 2022, View Source [SID1234622714]).

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Dr. Tucker will participate in the panel Synthetic vs Natural Debate on Saturday, November 5th at 12:00 p.m. ET.

On November 1, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2022 and raised net sales guidance for INGREZZA in 2022 (Press release, Neurocrine Biosciences, NOV 1, 2022, View Source [SID1234622713]).

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"INGREZZA continues to help more and more patients who suffer from tardive dyskinesia. With the submission of the sNDA of valbenazine for the treatment of chorea associated with Huntington Disease, we have the potential to help even more patients with our valbenazine franchise," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Our clinical programs continue to progress with multiple data readouts in 2023 including for crinecerfont in congenital adrenal hyperplasia and for NBI-‘352 in adult focal onset seizures. Additionally, we recently dosed our first patient in our lead muscarinic program for the treatment of schizophrenia. With a strong commercial and R&D presence, and an attractive financial profile, Neurocrine Biosciences is well positioned to be a leading neuroscience-focused company."

Third Quarter INGREZZA Net Product Sales and Commercial Highlights:
Net product sales were $376 million with total prescriptions (TRx) of approximately 68,600
Net product sales and TRx grew 31% and 32%, respectively, vs. third quarter of 2021
Sequential growth driven by record new patients and continued strength in existing patients’ refill rates
Financial Highlights:
Third quarter 2022 GAAP net income and diluted earnings per share of $69 million and $0.69, respectively, compared with $23 million and $0.23, respectively, for third quarter 2021.
Third quarter 2022 non-GAAP net income and diluted earnings per share of $107 million and $1.08, respectively, compared with $63 million and $0.64, respectively, for third quarter 2021.
Differences in third quarter 2022 GAAP and non-GAAP operating expenses compared with third quarter 2021 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio
Increased SG&A expense primarily due to ongoing commercial initiatives, including the deployment of the expanded salesforce in April 2022
At September 30, 2022, the Company had cash, cash equivalents and marketable securities of approximately $1.2 billion.
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events:
On November 1, 2022, we acquired Diurnal Group plc, or Diurnal, in an all-cash transaction, for an aggregate value of approximately £48.3 million GBP, or approximately $56 million USD. We believe the transaction presents an opportunity to accelerate the establishment of our clinical development and commercial capabilities in the United Kingdom to the benefit of patient communities and other stakeholders.

INGREZZA sales guidance for fiscal 2022 is based on recent trends and the anticipated benefit from our recently completed salesforce expansion. If new COVID-19 related disruptions emerge, the Company’s ability to meet these expectations could be negatively impacted.
GAAP R&D guidance includes (i) amounts for milestones that are probable of achievement or have been achieved and (ii) amounts for in-process research and development once significant collaboration and licensing arrangements have been completed. GAAP R&D guidance includes approximately $40 million of milestone expenses in connection with collaborations.
Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $60 million in R&D and $110 million in SG&A.
Based upon available Federal net operating losses and tax credits, the Company expects to begin making cash payments for Federal income tax beginning in the fourth quarter of 2022.

Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1881 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On November 1, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that its third quarter 2022 financial results will be released after market close on Tuesday, November 8th, 2022 (Press release, Coherus Biosciences, NOV 1, 2022, View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2022-financial-results" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-third-quarter-2022-financial-results" rel="nofollow">View Source [SID1234622712]). Starting at 5:00 p.m. Eastern Time on November 8, 2022, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update. The press release with the third quarter 2022 financial results and related materials will be available at View Source prior to the start of the conference call.

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A replay of the webcast will be available on View Source following the conclusion of the live conference call.

On November 1, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS) reported financial results for the third quarter and nine months ended September 30, 2022 and provided a corporate update (Press release, Pyxis Oncology, NOV 1, 2022, View Source [SID1234622711]).

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"The expansion of our exclusive in-licensing agreement with Pfizer continues to strengthen our development and partnership capabilities through exclusive access to Pfizer’s ADC technology platform and toolkit with first right of access to all available Pfizer ADC targets and associated technology," said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "As Pfizer’s exclusive sublicensing agent for its ADC technology, our team has already concluded the first multi-target sublicensing agreement with a stealth ADC company demonstrating the durable value of this platform as well as industry interest in the technology. We look forward to further collaborating with other industry partners to fully leverage the potential of this intellectual property."

Jeff Settleman, Ph.D., Senior Vice President and Chief Scientific Officer for Oncology Research and Development at Pfizer, added, "We are proud to strengthen our agreement with Pyxis Oncology. Pyxis Oncology has assembled a talented team, and we are confident in their ability to fully realize the platform’s clinical potential."

Corporate Development Highlights

•Pfizer exclusively out-licensed the entirety of its ADC technology platform and toolkit to Pyxis Oncology: Under the terms of the agreement, Pyxis Oncology has exclusive access to Pfizer’s ADC technology platform and toolkit (excluding antibodies) to develop and commercialize ADCs directed to all available Pfizer ADC targets. The amended agreement provides Pyxis Oncology with the flexibility to sublicense either the full platform or certain components of the platform to third parties. Pyxis Oncology has concluded its first multi-target sublicensing agreement under the new arrangement with a stealth ADC company. This expansion builds on the former agreement, which provided Pyxis Oncology with a worldwide, royalty-bearing license to develop and commercialize multiple ADC candidates.

•Pyxis Oncology continues to advance lead programs toward the clinic with near-term catalysts: Pyxis Oncology remains on track with its IND plans for PYX-106 and PYX-201 by the end of this year. The company remains confident in the clinical and commercial opportunity for both programs based on the in vivo preclinical data to date and looks forward to working with the FDA to advance both programs into clinical development. PYX-201 is a novel, non-internalized ADC directed against a first-in-class target (EDB), which is selectively expressed in a large population of non-small cell lung cancer, breast cancer, and other solid tumors. PYX-106 is a highly potent immunotherapy that blocks the activity of Siglec-15, an emerging immune suppressor expressed across a broad range of tumors.

"Our team believes in the potential of marrying internal and external development strategies to accelerate promising therapeutics for patients with difficult-to-treat cancers," continued Dr. Sullivan. "In addition to strengthening our current partnerships, we see a significant opportunity to leverage our strong balance sheet and our team’s extensive industry networks to explore new avenues of scientific and therapeutic advancement."

Financial Update for Quarter Ended September 30, 2022

•Pyxis Oncology had cash and cash equivalents (including restricted cash) of $200.0 million as of September 30, 2022, which is expected to fund operations into the end of 2024.
•Research and development expenses were $19.0 million for the three months ended September 30, 2022, compared to $7.8 million for the three months ended September 30, 2021. The increase was primarily due to increased expenses associated with contract manufacturing of drug products and drug substance, preclinical cost related to toxicity studies and an increase in employee headcount to support research and development activities.
•General and administrative expenses were $9.4 million for the three months ended September 30, 2022, compared to $3.8 million for the three months ended September 30, 2021. The increase was primarily due to a higher personnel-related expenses (including stock-based compensation), and an increase in legal and professional fees, rent and directors and officers insurance expense to support our growth and operations.
•Net loss was $27.7 million, or $(0.85) per common share, for the three months ended September 30, 2022, compared to $14.2 million, or $(8.96) per common share, for the three months ended September 30, 2021. Net loss for the three months ended September 30, 2022 and 2021 included $4.4 million and $0.3 million, respectively, related to non-cash stock-based compensation expense.
•As of November 1, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 35,097,256.