On November 15, 2023 Alkermes plc (Nasdaq: ALKS) reported that it has completed the separation of its oncology business into Mural Oncology plc (Mural Oncology), a new, independent, publicly traded company (Press release, Alkermes, NOV 15, 2023, View Source [SID1234637695]). Alkermes is now a pure-play, profitable neuroscience company that will continue its work to develop innovative medicines for people living with difficult-to-treat psychiatric and neurological disorders. Mural Oncology will begin "regular way" trading on the Nasdaq Global Market under the stock ticker symbol "MURA" on Nov. 16, 2023. Alkermes will continue to trade under the Nasdaq ticker symbol "ALKS."

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"The separation of our oncology business was an important element of our strategy to transform Alkermes into a pure-play neuroscience company with the potential to generate strong profitability and cash flow. With a topline driven by the growth of our proprietary commercial products, proven drug development capabilities, and an important pipeline opportunity in our ALKS 2680 orexin program, we believe we are well positioned to drive value for Alkermes shareholders," said Richard Pops, Chief Executive Officer of Alkermes.

Updated Financial Expectations for 2023
Alkermes is providing the following updated financial expectations for 2023. These improved expectations reflect the company’s year-to-date financial results through Sept. 30, 2023 and the completion of the separation of the oncology business. The separation is associated with an anticipated reduction in operating expenses of approximately $20 million during the last six weeks of 2023, primarily consisting of Research and Development expenses.

Net income according to generally accepted accounting principles in the U.S. (GAAP) is now expected to be in the range of $250 million to $280 million, revised from the prior expectation of $225 million to $265 million. GAAP earnings per share (diluted)+ are now expected to be in the range of $1.46 to $1.63, revised from the prior expectation of $1.31 to $1.54.
Non-GAAP net income is now expected to be in the range of $270 million to $300 million, revised from the prior expectation of $230 million to $270 million. Non-GAAP earnings per share (diluted)+ are now expected to be in the range of $1.57 to $1.75, revised from the prior expectation of $1.34 to $1.57.
+2023 per share expectations are calculated based on a weighted average basic share count of approximately 166.5 million shares outstanding and a weighted average diluted share count of approximately 171.5 million shares outstanding.

At Sept. 30, 2023, Alkermes recorded cash, cash equivalents and total investments of $995.6 million. In connection with the completion of the separation, Alkermes capitalized Mural Oncology with cash of $275 million.

Upon completion of the separation, each of Alkermes’ shareholders received a distribution of one ordinary share of Mural Oncology for every 10 ordinary shares of Alkermes held as of the close of business on Nov. 6, 2023, the record date for the distribution. Cash will be delivered in lieu of any fractional ordinary shares of Mural Oncology.

The separation and distribution have been structured to qualify as a tax-free distribution (except for cash received in lieu of fractional shares) to Alkermes’ shareholders and the company and its affiliates for U.S. federal income tax purposes. Alkermes’ shareholders are urged to consult with their tax advisors with respect to the U.S. federal, state, local and foreign tax consequences of the separation.

Morgan Stanley & Co. LLC and BofA Securities, Inc. served as financial advisers to Alkermes, and Goodwin Procter LLP and Arthur Cox LLP served as its legal counsel.

On November 15, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported financial results for the third quarter 2023 and provided a business update (Press release, AIM ImmunoTech, NOV 15, 2023, View Source [SID1234637694]). As previously announced, the Company will host a conference call and webcast today, Wednesday, November 15, 2023, at 8:30 AM ET (details below).

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"Our team continues to make significant strides in the advancement of Ampligen through our active human clinical studies in multiple indications, including pancreatic cancer, ovarian cancer and post-COVID conditions. Our clinical and operational execution is supported by a strong cash position and we are poised for an exciting period ahead as we approach a number of value-driving milestones, particularly in our ovarian and pancreatic cancer programs. We are dedicated to driving our clinical programs forward and building momentum to generate value for our shareholders," commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

Announced encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen in patients with platinum-sensitive advanced recurrent ovarian cancer.
Engaged Azenova, LLC, a professional business development consulting firm, to support efforts to partner AIM’s pipeline programs with a particular focus on the company’s lead asset, Ampligen, for the treatment of various malignant solid tumors.
Presented an overview of Ampligen’s clinical progress in oncology at the 3rd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care.
Announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC). The complete topline results are now available on ClinicalTrials.gov: NCT04081389.
Upcoming Expected Ampligen Milestones

Q4 2023

Locally advanced pancreatic cancer (AMP-270) – Open European site
Metastatic pancreatic cancer (DURIPANC, Collaboration with AstraZeneca) – Begin clinical trial
Advanced Recurrent Ovarian Cancer – Protocol-planned interim results
Post-COVID Conditions (AMP-518) – Final subject completes Phase 2 study
Q1 2024

Post-COVID Conditions (AMP-518) – Topline data from Phase 2 study expected
Summary of Financial Highlights for Third Quarter 2023

As of September 30, 2023, AIM reported cash, cash equivalents and marketable investments of $22.4 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones.
Research and development expenses for the three months ended September 30, 2023, were $2.7 million, compared to $1.4 million for the same period in 2022.
General and administrative expenses were $5.4 million for the three months ended September 30, 2023, compared to the $5.2 million for the same period in 2022.
The net loss from operations for the three months ended September 30, 2023, was $7.8 million, or $0.16 per share, compared to $6.4 million, or $0.13 per share, for the three months ended September 30, 2022.
Please refer to the full 10-Q for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and live audio webcast to discuss the operational and financial results today, Wednesday, November 15, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On November 14, 2023 EMulate Therapeutics, Inc. (EMTx) reported the acceptance of their abstract for presentation and publication in the 28th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), November 2023, in Vancouver, British Columbia (Press release, EMulate Therapeutics, NOV 14, 2023, View Source [SID1234637680]). The accepted abstract will be published in SNO’s official journal, Neuro-Oncology, which is now available at View Source

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The abstract describes the poster material developed by EMTx for the SNO meeting and can be downloaded from EMTx’s website for viewing here. The title of the abstract and poster are: "Low/Ultra-low Radio Frequency Magnetic Field Therapies for the Treatment of CNS Tumors: rGBM and DIPG – Past and Current Results Using the EMulate Therapeutics, Inc. Technology."

"EMTx continues to move forward with research in support of the humanitarian device exemption (HDE) application to FDA," said Chris Rivera, CEO of EMTx. "The data we are presenting in our SNO poster demonstrates mechanisms of action and increased survival time in a DMG/DIPG animal model of the EMTx technology using the A1A signal. These data are in addition to safety and benefit data demonstrated in our compassionate use study for the DMG/DIPG indication."

"We believe that the results and publication of our recurrent glioblastoma clinical trials may provide support in our HDE application for DMG/DIPG," stated Dr. Xavier Figueroa, Pre-clinical Director for EMTx. "While there is no guarantee that our HDE application will be approved, the needs of this underserved pediatric population and the demonstrated safety profile of our therapeutic device give us reason to feel confident that the FDA will grant us HDE approval."

Diffuse intrinsic pontine glioma (DIPG, a subset of diffuse midline glioma) primarily affects children, mostly diagnosed between 5 and 7 years of age. DIPG makes up 10-15% of all brain tumors in children, with about 150-300 new diagnoses per year in the United States. Unfortunately, median survival for children diagnosed with this disease is only 9-10 months.

Glioblastoma multiforme (GBM) is the most common type of malignant (cancerous) brain tumor in adults. More than 13,000 Americans are diagnosed with GBM every year. GBM accounts for almost half of all cancerous brain tumors. GBM commonly affects people aged 45 to 70. Most people live on average 12 to 18 months after diagnosis. Only about 7% of people are still alive in five years.

EMTx is dedicated to changing the treatment and prolonging survival in both DIPG and GBM.

On November 14, 2023 Agilent Technologies Inc. (NYSE: A) reported that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Agilent, NOV 14, 2023, View Source [SID1234637677]).

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PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic that can identify gastric or GEJ adenocarcinoma patients suitable for treatment with KEYTRUDA in combination with chemotherapy and trastuzumab plus fluoropyrimidine. This marks the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval.

Lou Welebob, vice president and general manager of Agilent’s Pathology Division, stated, "PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. This endorsement underscores Agilent’s leadership in the development of companion diagnostics for groundbreaking anti-PD-1 therapies."

In addition to gastric or GEJ adenocarcinoma, PD-L1 IHC 22C3 pharmDx also helps physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), and triple-negative breast cancer (TNBC) who may benefit from treatment with KEYTRUDA.

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2‑positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Gastric cancer is a leading cause of cancer-related mortality worldwide1. The incidence of GEJ adenocarcinoma is on the rise and is considered one of the fastest growing cancers in the country 1,2.

KEYTRUDA is a humanized monoclonal antibody that enhances the immune system’s ability to detect and fight tumor cells. It works by blocking the PD-1 pathway, activating T lymphocytes that may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment across a growing list of cancer types.

PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 14, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that it has entered into an agreement with Merck, known as MSD outside the United States and Canada, under which Merck will utilize Natera’s real-world database (RWD) to advance oncology research (Press release, Merck & Co, NOV 14, 2023, View Source [SID1234637676]).

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Natera’s oncology RWD contains de-identified clinical and genomic data from more than 100,000 early- and late-stage patients with cancer who have been tested with Signatera, the company’s personalized and tumor-informed molecular residual disease (MRD) test. Longitudinal monitoring data is available for the majority of patients, providing an objective measure of molecular response to treatment and connected to a multi-modal database that includes clinical outcomes, genomic profiling, and imaging. Pharmaceutical companies can use Natera’s RWD to strategically advance drug development programs across early-stage and metastatic settings.

"With Signatera being ordered now on a regular basis by over a third of all oncologists in the U.S., Natera is in a unique position to structure and share its real-world experience to inform drug discovery and clinical research," said John Fesko, Natera’s president & chief business officer.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.