On November 13, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and provided financial results for the third quarter of 2023 ended September 30, 2023 (Press release, Enveric Biosciences, NOV 13, 2023, View Source [SID1234637537]).

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"The third quarter of 2023 was a period of significant progress for our team as we completed several initiatives that served to enhance the value of our differentiated neuroplastogenic small-molecule therapeutics as we advance towards the clinic," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Key to this effort, we significantly strengthened our IP estate across our development portfolio, highlighted by new patents from the United States Patent and Trademark Office (USPTO) for our EVM301 Series of novel non-hallucinogenic molecules and for EB-373, our lead EVM201 Series prodrug product candidate. The patents encompass composition of matter and pharmaceutical drug formulations related to the EVM301 Series and composition of matter and pharmaceutical drug formulations pertaining to EB-373. Additionally, we filed six non-U.S. applications related to the EVM301 Series, received several U.S. Notices of Allowance for claims related to the EVM301 Series and EB-373, and filed a new application for our AI-based computational methods for identifying and optimizing novel tryptamine derivatives. Our expectation is the USPTO will grant patents based on the Notices of Allowance, which would continue to increase the value of our technologies and further distinguish Enveric’s science as groundbreaking and unique."

Dr. Tucker added: "Through the third quarter of 2023 and into Q4, we have showcased the leading drug discovery and research engine behind our EVM301 Series of compounds, with several publications and presentations in academic settings, establishing a leading position in the psychedelic and psychedelic-inspired drug development industry to deliver next-generation treatments, with low- and non-hallucinogenic compounds. We look forward to several key milestones during the remainder of 2023, including identification of a lead candidate from the EVM301 Series by year-end. With this lead candidate identified, we anticipate initiating a thorough and expedited preclinical development program in 2024 in preparation for an Investigational New Drug application."

"As part of our objective to ensure clinical readiness, the third quarter was also characterized by completing key manufacturing and preclinical activities needed to file for regulatory clearance to begin a first in human clinical trial of EB-373. We announced favorable results from exploratory animal studies, which demonstrated oral bioavailability and well-tolerated side effects for EB-373. The outcome of these animal studies indicated potential for EB-373 to reduce GI upset and vomiting as well as rapid onset of action and systemic clearance, improving on the pharmacokinetic characteristics of psilocybin. Additionally, further preclinical work assessing absorption, distribution, metabolism, and excretion (ADME) assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin," concluded Dr. Tucker.

THIRD QUARTER AND RECENT PROGRAM UPDATES

Presented and published leading scientific research describing development and screening methods for non-hallucinogenic, neuroplastogenic drug candidates in Enveric’s EVM301 Series of candidates targeting the treatment of mental health disorders
Showcased drug candidate generation engine surpassing 1000 compounds discovered and analyzed in Psybrary Portfolio of psychedelic-inspired therapeutic candidates
Published research describing a key cane toad enzyme and its application to the biosynthesis of novel indolethylamine-type drug candidates with potential use in psychiatric medicine
Reported results from preclinical studies exploring the metabolic profile and the safety of lead candidate EB-373, a next generation psilocin prodrug targeting psychiatric disorders. Reported favorable preclinical absorption, distribution, metabolism, and excretion (ADME) and toxicology assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin
Completed manufacturing of EB-373 to supply drug material for completion of preclinical program with resulting high purity of prodrug product that allows Enveric and partners to ship EB-373 without being subject to restrictions required for controlled substances
Continued to drive value with growing IP portfolio across therapeutic pipeline and filed provisional patent application to support AI-based computational methods for identifying and optimizing novel tryptamine derivatives
Granted USPTO No. 11,707,447 encompassing compositions of matter and pharmaceutical drug formulations for prodrugs utilizing C4-substituted tryptamine derivatives and C4-carbonothiate-substituted tryptamine derivatives
Granted USPTO No. 11,752,130 providing claims to novel composition of matter and pharmaceutical drug formulations for a family of carboxylated derivatives of tryptamine-based drug candidates
THIRD QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $2.82 million for the third quarter ended September 30, 2023, including $0.16 million in net non-cash income, with a basic and diluted loss per share of $1.30, as compared to a net loss of $2.60 million and non-cash income of $2.29 million, with primary and diluted loss per share of $1.46 per share for the quarter ended September 30, 2022.

Net cash used in operations for the quarter ended September 30, 2023, was $2.98 million, consisting of a $2.82 million net loss, adjusted by a net of $0.16 million in non-cash income and changes in asset and liability balances of $0.23 million.

As of September 30, 2023, the Company had cash and cash equivalents of $4.27 million.

On November 13, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that it will present updated efficacy data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (the EOGBM1-18/ROSALIE study), in an oral presentation at the Society for Neuro-Oncology (SNO) 28th Annual Meeting which will be held in Vancouver, British Columbia, Canada on November 15-19, 2023 (Press release, Enterome, NOV 13, 2023, View Source [SID1234637536]).

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Oral presentation details – Abstract CTIM-25

Title: EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: the phase 1/2 EOGBM1-18/ROSALIE study (NCT04116658)

Presenting Author: Prof. David Reardon, M.D., Professor of Medicine at Harvard Medical School, and Clinical Director for Dana Farber Cancer Institute

Session Name: Abstract Concurrent Session: Clinical Trials – Immunologic

Session Date and Time: Friday, November 17, 2023, at 8:35 AM PST

Location: Room 109-110

Link to abstract published in a supplement to Neuro-Oncology, the Official Journal of the Society for Neuro-Oncology, can be found here. The slides from the oral presentation will be available on Enterome’s website after the Meeting.

About ROSALIE

ROSALIE (EOGBM1-18) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) +/- bevacizumab for the treatment of patients with first progression/recurrence of glioblastoma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in 100 patients enrolled at 10 clinical sites in Europe and the US.
For more information on the Phase 1/2 trial of EO2401 in recurrent glioblastoma, please refer to ClinicalTrials.gov Identifier: NCT04116658

About OncoMimics

OncoMimics immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer.

On November 13, 2023 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the third quarter ended September 30, 2023 (Press release, Delcath Systems, NOV 13, 2023, View Source [SID1234637535]).

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Recent Business Highlights

Received approval from the US Food and Drug Administration (FDA) for HEPZATO KIT (melphalan)/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation;
Raised approximately $35 million through the exercise of all the Tranche A warrants issued as part the previously announced March 29, 2023, financing with up to an additional $25 million available upon the achievement of $10 million in quarterly revenue;
Announced publication by independent investigators of a retrospective comparative study of CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) and Selective Internal Radiation Therapy (SIRT) citing a statistically significant difference in median overall survival with 301 days for SIRT and 516 days for PHP;
Announced that independent investigators at Leiden University recruited 55 of 76 planned patients in the CHOPIN trial studying the impact of CHEMOSAT and immune checkpoint inhibitor combination therapy in the treatment of metastatic uveal melanoma and expect the trial to be fully enrolled mid-2024. An interim futility analysis conducted in September resulted in the independent data monitoring committee recommending continuing the study without modification; and
Partnered with seven clinical treatment sites to satisfy the initial training requirements to be able to treat their first commercial patient, subject to proctor availability and the sites’ value analysis committee approvals, upon the planned launch in January.
"The Company has been preparing for a January launch of HEPZATO KIT by building our commercial team and engaging with potential treating centers," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, "We have been encouraged by the reception that HEPZATO KIT has received from the medical oncologist community and are confident that by the end of 2024 at least 15 centers will be actively treating metastatic uveal melanoma patients with HEPZATO KIT."

Third Quarter 2023 Results

Total revenue for the three months ended September 30, 2023, was approximately $0.4 million, compared to $0.9 million for the prior year period, from our sales of CHEMOSAT in Europe.

Research and development expenses for the quarter were $4.7 million, compared to $4.1 million in the prior year quarter. The increase in R&D expense is primarily due to completing clinical trial activities and expenses related to the FDA inspection and other requests in advance of the approval received for HEPZATO.

Selling, general and administrative expenses for the quarter increased to $6.2 million, compared to $4.8 million in the prior year quarter primarily relating to activities to prepare for a commercial launch. The increase in fair value warrant liability adjustment during the quarter ended September 20, 20223 was a result of our final valuation for the Tranche A warrants exercised and outstanding Tranche B warrants.

On November 13, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported third quarter financial results and provided a business update (Press release, Cyclacel, NOV 13, 2023, View Source [SID1234637534]).

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"Fadraciclib continues to show good tolerability and anticancer activity as a single agent," said Spiro Rombotis, President and Chief Executive Officer. "After analyzing the genomic profile of several Phase 1 patients with clinical benefit, we have identified mutational and molecular patterns that may be predictive of clinical activity across broad cancer types. If confirmed, these findings may be relevant in the upcoming Phase 2 part of our 065-101 study. In our Phase 1/2 study of plogosertib good tolerability and anticancer activity as a single agent has been observed in multiple patients with various solid tumors. Preclinical data continues to suggest that plogosertib may work through an epigenetic mechanism and that certain mutational biomarkers may identify patients with sensitive tumors. We look forward to presenting data from these two programs and their mechanisms in the coming months."

"In the 065-101 study of oral fadraciclib, our CDK2/9 inhibitor, as monotherapy, we are completing dose escalation level 6A with six patients and expect to select the recommended Phase 2 dosing schedule shortly. We are encouraged by the observations of anticancer activity and the related patient genomic profiles," said Mark Kirschbaum, M.D., Chief Medical Officer. "We believe that fadraciclib’s inhibition of CDK2 and CDK9 may be superior to either CDK2 or CDK9 alone. Importantly, we have been able to give fadraciclib orally with repeat dosing which has led to transient suppression of anti-apoptosis proteins without hematological toxicity. In the 140-101 study of oral plogosertib, our PLK1 inhibitor as a single agent, we are recruiting patients at dose level 5. The anticancer activity observed at low levels of continuous exposure may be due to plogosertib’s novel epigenetic mechanism which we are continuing to investigate. If confirmed, we intend to design clinical studies that could exploit these findings."

Key Milestones

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
· First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
· Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
· Disclose novel epigenetic mechanism of action of plogosertib

Financial Highlights

As of September 30, 2023, cash equivalents totaled $5.9 million, compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $12.2 million for the nine months ended September 30, 2023 compared to $15.7 million for the same period of 2022. The Company estimates that its available cash will fund currently planned programs through the end of 2023. The operating plan includes discretionary expenditures, which if not incurred could extend cash runway into the second quarter of 2024.

Research and development (R&D) expenses were $5.2 million for the three months ended September 30, 2023, as compared to $4.4 million for the same period in 2022. R&D expenses relating to fadraciclib were $3.6 million for the three months ended September 30, 2023, as compared to $2.5 million for the same period in 2022 due to due to increased costs associated with manufacture scale up and introduction of the tablet form. R&D expenses related to plogosertib were $1.5 million for the three months ended September 30, 2023, as compared to $1.7 million for the same period in 2022.

General and administrative expenses for the three months ended September 30, 2023 were $1.6 million, as compared to $2.1 million for the same period in 2022 due to non-recurring professional fees of $0.4 million in the prior period.

Total other income, net, for the three months ended September 30, 2023, was $0.1 million compared to an income of $0.4 million for the same period of the previous year.

United Kingdom research & development tax credits for the three months ended September 30, 2023 were $0.6 million compared to $1.0 million for the same period of the previous year due to taxation legislative changes that took effect in April 2023 and reduced the amount of tax credit that could be claimed. Research & development tax credits are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended September 30, 2023, was $6.1 million, compared to $5.1 million for the same period in 2022.

Conference call information:

Call: (800) 245-3047 / international call: (203) 518-9765

Archive: (800) 688-7036 / international archive: (402) 220-1346

Code for live and archived conference call is CYCCQ323. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On November 13, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the third quarter ended September 30, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, NOV 13, 2023, View Source [SID1234637533]).

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"The January 3, 2024, action date for our Biologics License Application ("BLA") for cosibelimab is fast-approaching, and we continue to work closely with the U.S. Food and Drug Administration ("FDA") in completing their review," said James Oliviero, President and Chief Executive Officer of Checkpoint. "During the third quarter, pivotal trial results for cosibelimab in metastatic cutaneous squamous cell carcinoma ("cSCC") were published in the peer-reviewed Journal for ImmunoTherapy of Cancer, which further supports the efficacy and safety of cosibelimab. We also reported longer-term data from our pivotal trials in both locally advanced and metastatic cSCC that demonstrate a deepening of response over time with substantially higher complete response rates. We firmly believe that cosibelimab’s clinical profile, which includes a unique dual mechanism of action and favorable safety profile, should position the product, upon its potential launch next year, as the preferred immunotherapy of oncologists, particularly for the large number of difficult-to-treat cSCC patients who continue to suffer poor outcomes with currently available treatments."

Recent Corporate Highlights:

Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023, Checkpoint announced the FDA accepted the BLA filing for cosibelimab and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. The FDA has indicated that an advisory committee meeting to discuss the application is not planned.
In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response with cosibelimab treatment over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time.
Also in July 2023, Checkpoint completed a registered direct offering priced at-the-market under Nasdaq rules for total gross proceeds of $10 million.
In October 2023, Checkpoint announced the exercise of previously issued warrants for $11.13 million in gross proceeds.
Also in October 2023, Checkpoint announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab in patients with metastatic cSCC in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The paper, entitled, "Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma" (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.
Financial Results:

Cash Position: As of September 30, 2023, Checkpoint’s cash and cash equivalents totaled $1.8 million, compared to $7.4 million at June 30, 2023 and $12.1 million at December 31, 2022, a decrease of $5.6 million for the quarter and a decrease of $10.3 million for the first nine months of 2023. Subsequent to the end of the third quarter, Checkpoint raised approximately $11.13 million of gross proceeds from the exercise of previously issued warrants.
R&D Expenses: Research and development expenses for the third quarter of 2023 were $5.5 million, compared to $8.9 million for the third quarter of 2022, a decrease of $3.4 million. Research and development expenses for the third quarters of 2023 and 2022 both included $0.3 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the third quarter of 2023 were $2.2 million, compared to $1.8 million for the third quarter of 2022, an increase of $0.4 million. General and administrative expenses for the third quarter of 2023 included $0.6 million of non-cash stock expenses, compared to $0.5 million for the third quarter of 2022.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2023 was $5.7 million, or $0.29 per share, compared to a net loss of $10.6 million, or $1.20 per share, in the third quarter of 2022. Net loss for the third quarter of 2023 included $0.9 million of non-cash stock expenses, compared to $0.8 million for the third quarter of 2022.