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Lilly to Participate in Evercore ISI HealthCONx Conference

On November 14, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will attend the sixth annual Evercore ISI HealthCONx Conference on Nov. 28, 2023. Daniel Skovronsky, M.D., Ph.D., executive vice president, chief scientific and medical officer, and president of Lilly Research Laboratories, will participate in a fireside chat at 3:50 p.m., Eastern time (Press release, Eli Lilly, NOV 14, 2023, https://investor.lilly.com/news-releases/news-release-details/lilly-participate-evercore-isi-healthconx-conference-0 [SID1234637622]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Defence’s Successful Submission of an Investigational New Drug (IND) Application for ACCUTOX® as an Injectable Anticancer Treatment for Solid Tumors

On November 14, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, USOTC: DTCFF, FSE: DTC), one of the leading Canadian biotechnology companies working in the field of immune-oncology reported that it has successfully submitted on November 9, 2023 an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its ACCUM-002TM Dimer CDCA-SV40 commonly named "AccuTOX", an injectable anticancer molecule, for the treatment of solid cancer tumors (Press release, Defence Therapeutics, NOV 14, 2023, View Source;utm_medium=rss&utm_campaign=defences-successful-submission-of-an-investigational-new-drug-ind-application-for-accutox-as-an-injectable-anticancer-treatment-for-solid-tumors [SID1234637621]).

AccuTOX is a derivative of the initial Accum molecule, which has been reported to target cancer on multiple fronts. AccuTOX disrupts endosomal membranes resulting in impaired intracellular transport mechanisms. AccuTOX also triggers genotoxic effects, blocks DNA repair mechanisms normally used by cancer cells to repair its damaged genome and induces a form of immunogenic cell death capable of turning "ON" the immune system. When previously tested in preclinical animal models under the supervision of Dr. Moutih Rafei, AccuTOX impaired tumor growth resulting in "70-100% survival" of animals with solid T-cell lymphoma, melanoma or breast cancer.

The IND application includes data, reports and overview summaries of numerous studies to evaluate the pharmacology, pharmacokinetics, and toxicology of AccuTOX both in vitro and in vivo, including cancer models. In addition, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. The main purpose of the IND is to share with the FDA the extensive non-clinical data supporting an acceptable safety profile when AccuTOX will be first administered to humans. The FDA will review the application and determine the acceptability of the data before Defence begins the Phase I clinical trial, which could be as early as Q1-Q2 2024.

"We are thrilled and excited that Defence has achieved a successful submission on its first IND, which represents an important milestone towards advancing AccuTOX into the clinic. We look forward to work with clinical investigators at City of Hope to study this important and novel candidate for the treatment of melanoma and potentially other solid tumors," said Sébastien Plouffe, President & CEO of Defence Therapeutics. "With the continued difficulties encountered in the oncology clinic, we believe that the therapeutic use of AccuTOX provides a novel and powerful approach to combat cancer," he added.

The primary objective of this upcoming Phase I clinical trial, when approved, is to identify the best therapeutic dosing range that would allow clinicians to co-administer the AccuTOX compound with Opdulag, a BMS product containing both anti-LAG3 and anti-PD-1. Several other secondary parameters including therapeutic efficacy will be monitored in treated patients in preparation for a Phase IIa trial on a basket of tumors.

According to Precedence Research, the global cancer therapeutics market size is expected to be worth around US$ 393.61 billion by 2032 from at US$ 164 billion in 2022, growing at a CAGR of 9.20% during the forecast period 2023 to 2032.

CORMEDIX INC. REPORTS THIRD QUARTER AND NINE MONTH 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

ON November 14, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events (Press release, CorMedix, NOV 14, 2023, View Source [SID1234637620]).

Recent Corporate Highlights:

The FDA completed a preapproval inspection for CorMedix’s primary finished dosage CMO site in September and the Company is pleased with the outcome. In addition, the FDA has also conducted preapproval inspections for DefenCath at suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities, and CorMedix is not aware of any outstanding deficiencies or review issues at this time.
CorMedix has intensified preparations for commercial launch with a number of new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance.
In the event CorMedix receives final FDA approval over the coming days, the Company is targeting a commercial launch before the end of the first quarter of 2024.
The United States Patent and Trademark Office (USPTO) issued a patent with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This Patent reflects the unique and proprietary nature of DefenCath, and will extend the Company’s intellectual property protection with an expiration date of April 15, 2042.
Cash and short-term investments, excluding restricted cash, at September 30, 2023 amounted to $86.6 million.
Joe Todisco, CorMedix CEO, commented, "I am very pleased with the Company’s progress on all fronts, most notably the outcomes of the preapproval inspections at our primary CMO facility and other key vendors, as well as our preparations toward commercial readiness. We have accelerated multiple work streams aimed at commercial launch, and made a number of key hires over the past quarter that are essential to ensuring a successful commercial launch following a potential FDA approval of DefenCath. We look forward to providing additional updates over the coming days as we anticipate a response from FDA on or around our target action date."

Third Quarter and Nine Month 2023 Financial Highlights

For the third quarter of 2023, CorMedix recorded a net loss of $9.7 million, or $0.17 per share, compared with a net loss of $6.9 million, or $0.17 per share, in the third quarter of 2022. The higher net loss recognized during the third quarter of 2023 compared with 2022 was attributable to net increase in operating expenses primarily due to increased pre-launch commercial activities for DefenCath.

Operating expenses in the third quarter of 2023 increased approximately 50% to $10.5 million, compared with $7.0 million in the third quarter of 2022. R&D expense increased approximately 14% to $2.7 million compared to $2.3 million in the third quarter of 2022, mainly due to a net increase in costs related to medical affairs activities and increase in personnel related expenses due to additional hires in 2023 as compared with 2022. SG&A expense increased approximately 69% to $7.8 million compared with $4.6 million in the third quarter of 2022. This increase was driven primarily by an increase in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath and as a result of additional hires in 2023 as compared with 2022.

For the nine months ended September 30, 2023, CorMedix recorded a net loss of $31.6 million, or $0.65 per share, compared with a net loss of $21.5 million, or $0.54 per share, in the first nine months of 2022. The increase in net loss in the first nine months of 2023 was driven primarily by an increase in operating expenses.

Operating expenses in the first nine months of 2023 were $33.3 million compared with $22.3 million during the comparable period in 2022, an increase of approximately 49%. This increase was primarily attributable to costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath, and an increase in personnel expenses due to additional hires in 2023.

Total cash on hand and short-term investments as of September 30, 2023 was $86.6 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2023, it has sufficient resources to fund operations at least twelve months from the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 14, 2023, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Domestic: 1-888-886-7786
International: 1-416-764-8658
Conference ID: 16013968
Webcast: Webcast Link

Atreca Reports Third Quarter 2023 Financial Results and Announces Further Reorganization to Support Exploration of Strategic Alternatives

On November 14, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the third quarter ended September 30, 2023, and announced that the Company is implementing a further reduction in its workforce of approximately 40% while maintaining the necessary support to continue exploring potential strategic transactions and business alternatives (Press release, Atreca, NOV 14, 2023, View Source [SID1234637619]).

"Since our founding, Atreca has leveraged a unique discovery platform to identify numerous antibodies binding novel targets in oncology, as well as infectious and autoimmune disease," said John Orwin. "We remain focused on advancing APN-497444 through preclinical testing and continue to believe that our approach has potential to unlock meaningful tumor targets undiscoverable by conventional approaches. Nevertheless, given current financial market conditions and the funding needs required to advance ‘444 and our other antibody-drug conjugate programs into clinical development, we have made the difficult decision to further reduce our headcount as we explore strategic alternatives. I’d like to thank all employees impacted for their contributions."

Third Quarter 2023 Financial Results

As of September 30, 2023, cash and cash equivalents and investments totaled $21.4 million.
Research and development expenses for the three months ended September 30, 2023, were $10.4 million, including non-cash stock-based compensation expense of $1.0 million.
General and administrative expenses for the three months ended September 30, 2023, were $5.4 million, including non-cash stock-based compensation expense of $1.3 million.
Atreca reported a net loss of $36.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.92, for the quarter ended September 30, 2023.

AIM ImmunoTech Announces Publication of Data from Roswell Park Comprehensive Cancer Center Phase 1 Study Evaluating Ampligen® as a Component of a Chemokine-Modulating (CKM) Regimen in Metastatic Triple-Negative Breast Cancer

On November 14, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab (Press release, AIM ImmunoTech, NOV 14, 2023, View Source [SID1234637617]). The data were published in a manuscript titled, "Systemic Infusion of TLR3-Ligand and IFNα in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx," in The Journal for ImmunoTherapy of Cancer.

The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon α-2b and celecoxib, and the combination’s ability to promote local CTL influx to mTNBC lesions. Principal investigator and first author Shipra Gandhi, MD, of the Department of Medicine at Roswell Park, led the study under the scientific leadership of Pawel Kalinski, MD, PhD, senior author of the paper, Chair of Immunology and Senior Vice President for Team Science at Roswell Park. For more information about the study, please visit ClinicalTrials.gov: NCT03599453.

For more information, please visit Roswell Park’s website to read its press release titled "Novel Immunotherapy Approach at Roswell Park Shows Promise in Metastatic Triple-Negative Breast Cancer."