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.

On November 14, 2023 TriSalus Life Sciences Inc., (Nasdaq: TLSI), a publicly traded oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported its financial results for the third quarter ended September 30, 2023, and provided a business update (Press release, TriSalus Life Sciences, NOV 14, 2023, View Source [SID1234637675]).

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"Today marks an important milestone for TriSalus as we host our first quarterly earnings call as a public company. I am proud of our team’s considerable progress in the commercialization of the TriNav Infusion System, our Pressure Enabled Drug Delivery (PEDD) method, which achieved $5.2 million in revenues in the quarter, up over 30% from the third quarter of 2022," said Mary Szela, Chief Executive Officer of TriSalus. "We remain focused on integrating the TriNav system with immunotherapy to transform treatment for patients with liver and pancreatic tumors by solving two main barriers to tumor treatment in the tumor microenvironment (TME): mechanical barriers that limit drug delivery and biological barriers to driving immunosuppression."

"Data from our three Phase 1/1b trials indicates that our innovative immunotherapy approach for liver and pancreas tumors has been well tolerated, with evidence of SD-101 being delivered into difficult to reach tumors, potentially overcoming limitations posed by intravenous or direct needle injection approaches. The mechanical and biologic TME barriers that TriSalus is targeting are commonly present in solid tumors, creating a significant opportunity to impact a large patient population across cancer types," commented Steven Katz, MD, FACS, Chief Medical Officer of TriSalus.

Third Quarter 2023 and Subsequent Highlights

PERIO-01 Phase 1 Data Selected for Late Breaking Podium Presentation at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

In November, TriSalus announced that SITC (Free SITC Whitepaper) had selected the PERIO-01 Phase 1 data for a late breaking podium presentation and participation in the press conference of its 2023 annual meeting. The data demonstrated that delivery of SD-101 by TriNav plus systemic immune checkpoint inhibitor (ICI) in uveal melanoma with liver metastases (UMLM) patients results in clinical activity with median progression free survival (PFS) of 11.7 months, myeloid derived suppressor cell (MDSC) re-programming, and evidence of peripheral and intra-tumoral immune activation.

PERIO-03 Phase 1 Initial Safety and Feasibility Data Selected for Poster Presentation at SITC (Free SITC Whitepaper) Annual Meeting

In November, the company presented data on its PERIO-03 Phase 1 clinical trial on pressure enabled intra-pancreatic delivery of SD-101 with checkpoint blockade for locally advanced pancreatic adenocarcinoma. The data demonstrated that TriNav pancreatic retrograde venous infusions (PRVI) of SD-101 were well tolerated in the initial three patients and infusions were associated with potentially favorable immune changes in the periphery and tumors. These findings support continuing with single-agent dose escalation and subsequent combination with systemic ICI.

The PERIO-03 Phase 1 study with single-agent SD-101 is expected to be completed at the end of 2023 with subsequent initiation of the Phase 1b PERIO-03 dose expansion beginning early 2024. In the expansion study, intravenous anti-PD-1 therapy will be added to SD-101 delivered by PEDD. The trial will target patients with unresectable, locally advanced pancreatic adenocarcinoma who failed or progressed on at least one line of standard therapy.

Jodi Devlin appointed as President, Commercial Operations

In September, TriSalus announced that Jodi Devlin was appointed as President, Commercial Operations. Ms. Devlin joined TriSalus with more than two decades of experience in building brands in a wide range of therapeutic areas, with expertise in developing and executing strategies across sales, marketing, medical affairs, market access, and policy for biotech and pharmaceutical products.

Financial Results

Revenue, all of which is from the sale of TriNav, was $5.2 million and $12.8 million, respectively, in the three and nine months ended September 30, 2023. These amounts represent growth vs. prior year of 32% in the third quarter and 39% for nine months year to date, primarily due to continued market share increases.

Gross margins were 89% in the third quarter ended September 30, 2023, and 84% for nine months year to date versus 82% and 84%, respectively, in the third quarter and year to date in 2022. The seven percent improvement in the third quarter of 2023 is due to increased factory volumes and improved operations efficiency.

Operating losses are $18.5 million and $40.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts include non-recurring professional service fee costs of $4.8 million in the quarter and $7.7 million year to date, primarily related to the completion of our deSPAC process in August 2023. These amounts compare to prior year losses of $8.1 million and $24.7 million, respectively. The Company increased investments in 2023 in R&D to support clinical program progress and in sales and marketing, primarily to expand its sales force to continue to increase market penetration.

Net losses attributable to common stockholders are $1.7 million and $27.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts compare to prior year losses of $8.1 million and $24.6 million, respectively. Net losses include the impact of a non-cash related gain on revaluation of contingent earnout liabilities of $19.9 million in the third quarter and nine-month period of 2023. In addition, net losses include the impact of non-cash related gains/(losses) associated with revaluation of tranche and warrant liabilities of ($2.8) million and $0.7 million, respectively, for the third quarter and nine-month period ending September 30, 2023. The nine-month period ending September 30, 2023 also includes a non-cash related loss on equity issuance of $4.2 million.

Basic and diluted loss per share for the three and nine months ended September 30, 2023, was $0.13 and $5.68, respectively, compared to a basic and diluted loss per share of $25.95 and $82.17 for the three and nine months ended September 30, 2022, respectively.

Conference Call

The event will be webcast live on the investor relations section of TriSalus’ website at View Source Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.