On November 14, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended September 30, 2022 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, NOV 14, 2022, View Source [SID1234624055]).

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"In the past quarter, we successfully expanded our potentially pivotal Berubicin trial into Europe with a number of clinical sites initiated and most recently the initiation of patient enrollment and dosing in France. This expansion into Europe drives us toward our goal of interim analysis, expected in mid-2023, which we believe has the potential to be transformational milestone. Moving forward, we are focused on building momentum and advancing this important program across the finish line," commented John Climaco, CEO of CNS Pharmaceuticals.

Berubicin Highlights
Ongoing potentially pivotal trial evaluating lead product candidate Berubicin for the treatment of recurrent glioblastoma multiforme (GBM)

Upcoming Milestones

Continued site initiations across the U.S., Italy, France, Spain, and Switzerland for potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM;
Regulatory and ethics approval in Italy;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected mid-year 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
The FDA has granted CNS Pharmaceuticals Fast Track Designation and Orphan Drug Designation for Berubicin. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Summary of Financial Results for the Third Quarter 2022
The net loss for the three months ended September 30, 2022 was approximately $3.4 million compared to approximately $3.8 million for the comparable period in 2021. The change in net loss is primarily attributable to decreases due to the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO expenses related to continued progress with our potentially pivotal clinical trial of Berubicin as well as increases in legal and professional fees and other expenses..

The Company reported Research and development expenses of $2.2 million for the three months ended September 30, 2022 compared to approximately $2.6 million for the comparable period in 2021. The change in net loss is primarily attributable to the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year, and this lower level of manufacturing activity is expected to continue throughout this year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in contract research organization (CRO) expenses related to continued progress with our potentially pivotal clinical trial of Berubicin..

General and administrative expense was approximately $1.2 million for the three months ended September 30, 2022 compared to approximately $1.2 million for the comparable period in 2021. This change is primarily due to decreases of approximately $204,000 for stock-based compensation, $46,000 in advertising and marketing, $32,000 in insurance and $31,000 in other expenses, which were offset by an increase of approximately $289,000 in legal and professional expenses.

As of September 30, 2022, the Company had cash of approximately $7.0 million and working capital of approximately $7.5 million. The Company’s current expectation is that the cash on hand and the proceeds from the offering during January is sufficient to fund our operations into the first quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

On November 14, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the third quarter ended September 30, 2022 (Press release, VolitionRX, NOV 14, 2022, View Source [SID1234624054]). Volition management will host a conference call tomorrow, November 15 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"I am delighted with the progress we have made across many of our Nu.Q pillars as we move forward from purely a research and development company to a commercial company with a wide range of innovative products. This quarter, and subsequent to quarter end, I am proud we have executed yet another global supply agreement with a market leader in pet healthcare," commented Cameron Reynolds, President and Group Chief Executive Officer of Volition.

"Our Nu.Q Vet Cancer Test is now available in the U.S., and soon to be available in Europe, through Heska Corporation’s veterinary diagnostic laboratories. This is a significant step forward in achieving our goal of making affordable canine cancer screening accessible worldwide, and we expect to see more companies launching our product soon. We also continued to make strong progress with Nu.Q NETs in terms of data publication, commencement of clinical studies, extending our KOL network and commencing commercial discussions with potential licensing targets. We believe that there is enormous potential for Nu.Q NETs to support clinical decision-making, enabling physicians to act quickly, and improve patient outcomes."

Company Highlights

Financial

Cash and cash equivalents as of September 30, 2022, totaled approximately $16.4 million compared with $16.7 million at the quarter ended June 30, 2022.
Received approximately $6.4 million net of underwriter’s fees and expenses in cash through an underwritten public offering of its common stock.
Secured a further $1.5 million in non-dilutive funding from Namur Invest Capital Risk in Belgium to fund an early access program for Volition’s Nu.Q product portfolio at key sites across the EU, UK, and U.S.
Continued to manage expenditures carefully with net cash used in operating activities averaging approximately $2.3 million per month in the quarter.
Nu.Q Vet

Subsequent to quarter end, announced the signing of a global supply agreement with a market leader in pet healthcare. Through this supply agreement Volition will provide the Nu.Q Vet Cancer Test through the counterparty’s extensive global reference laboratory network for cancer indications in animal health.
Subsequent to the quarter end, announced the launch of our Nu.Q Vet Cancer Test across the U.S. and the forthcoming launch in Europe by Heska Corporation, also one of the leading global providers of advanced veterinary diagnostics, through Heska’s veterinary diagnostic laboratories. Launching via Heska’s reference laboratory network is an important achievement in the parties’ transformative work together as Volition moves towards the launch of Heska’s flagship point of care solution anticipated in early 2023.
Subsequent to quarter end, announced a clinical research study with Oncovet, a renowned veterinary referral clinic, specializing in medical and radiation oncology led by Dr. Jérôme Benoit.
Volition anticipates launching with at least one other company before the end of 2022, which would bring the total to five global and in-country company licensees running Volition’s test.
Nu.Q NETs

Appointed DXOCRO to undertake development and clinical validation studies for Volition’s Nu.Q product portfolio in the United States.
DXOCRO will conduct large-scale finding studies across multiple sites in the U.S. using Volition’s Nu.Q NETs and Nu.Q Cancer tests to determine clinical utility in sepsis and cancer.
Volition anticipates that subsequent studies will investigate the chosen intended use claims of the tests, with the objective to gain clearance, authorization, or approval from the United States Food and Drug Administration (the "FDA") and allow the tests to be marketed in the U.S.
These multi-site studies will help demonstrate how Volition’s Nucleosomics technology can directly benefit patients and support its application to the FDA’s Breakthrough Devices Program and a Pre-submission anticipated in 2023.
Announced a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of NETs in human cancer patients with sepsis.
In collaboration with researchers at the University of Namur and QUALIblood in Belgium, published:
a clinical paper entitled "NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study" , and
a poster presentation entitled "Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients" at the International Society on Thrombosis and Haemostasis (ISTH) Congress in July.
Subsequent to the quarter end, presented data at the International Symposium on Infections in the Critically Ill Patient and International Sepsis Forum.
The key findings presented are that levels of NETosis as measured by Volition’s Nu.Q NETs test are highly elevated in sepsis and moreover that the test results correlate very well with the severity of disease (Sequential Organ Failure Assessment, or SOFA score).
Sponsored a GenomeWeb webinar titled ‘The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease’. To watch on demand, visit the GenomeWeb website.
Commenced a Market Access Program with European Key Opinion Leaders and early adopters.

Nu.Q Cancer

Announced Volition’s participation in a government-backed prospective study to evaluate the performance of blood biomarkers in the early detection of lung cancer with Hospices Civils de Lyon (HCL), France’s second largest university hospital.
The Lyonnaise Initiative for the Initiation of Lung Cancer Screening (ILYAD) is a wide-ranging clinical study assessing the feasibility of a lung cancer screening program and the effectiveness of screening.
The ILYAD study will evaluate the performance of Volition’s Nu.Q test as a blood biomarker for the early detection of lung cancer, when used alone and in conjunction with CT scan, over the next year with the ultimate goal of developing a national screening program in France.
Upcoming Priorities

Drive near term revenue in the following key areas:
License the Nu.Q platform, with a particular but not exclusive focus on Nu.Q Vet and Nu.Q NETs.
Work closely with Volition’s veterinary licensors to launch the Nu.Q Vet Cancer Test across a number of markets via both reference laboratories and point of care, resulting in :
sales of key components of point of care test with Heska.
sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.
Achieve the remaining milestones under the Heska Corporation agreement and receive the corresponding substantial milestone payments.
Fulfill ongoing and enter into new Nu.Q Discover agreements.
Continue to progress the research program for the use of Nu.Q NETs in monitoring disease progression of sepsis and potentially other diseases and as a possible companion diagnostic for the treatment of sepsis.
Continue to advance Volition’s previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of Volition’s Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend Volition’s intellectual property portfolio.
Event: VolitionRx Limited Third Quarter 2022 Earnings and Business Update Conference Call
Date: Tuesday, November 15, 2022
Time: 08:30 a.m. U.S. Eastern Time

Cameron Reynolds, President and Group Chief Executive Officer of Volition, will host the call along with Terig Hughes, Group Chief Financial Officer, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on important events which have taken place in the third quarter of 2022 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until November 29, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13734304.

On November 14, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, reported financial results for its second quarter ended September 30, 2022 and provided an update on recent developments (Press release, Aethlon Medical, NOV 14, 2022, View Source [SID1234624053]).

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Company Updates
Aethlon Medical is continuing the research and clinical development of its Hemopurifier, a therapeutic blood filtration system that can bind and remove harmful exosomes and life-threatening viruses from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

Due to a scarcity of COVID patients in intensive care units eligible for enrollment into our U.S. COVID trial, we recently decided to terminate the agreement with our contract research organization (CRO). As a result, while our Investigational Device Exemption (IDE) related to severe viral infections remains open, we are discontinuing U.S. COVID clinical trial activity. We expect this decision to save the company up to $5 million over the next twelve months, which we intend to allocate towards advancing the study of our Hemopurifier in oncology.
Due to lack of patient enrollment by the University of Pittsburgh Medical Center (UPMC) in our head and neck cancer safety trial, we and UPMC have terminated this study. We are planning a new clinical trial in oncology that will potentially include more tumor types, enabling us to build our safety database in oncology and provide data to help direct the development of our Hemopurifier as a treatment option in oncology. We are in the latter stages of selecting a new CRO to supervise this new oncology study.
In October 2022, we launched a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval, and commercialize our Hemopurifier in that country. The subsidiary will initially focus on the oncology market in Australia. Once selected, it is likely that our new CRO will oversee planned oncology studies in both the U.S. and Australia.
Our COVID-19 trial site in India remains open with the goal of enrolling additional COVID-19 patients. We are considering opening an oncology trial in India as well.
The addition of a second supplier for Galanthus nivalis agglutinin (GNA), used in the resin of our Hemopurifier, is delayed in the U.S., pending approval by the U.S. Food and Drug Administration (FDA) of the supplement to our IDE required to enact this manufacturing change. In our opinion, the FDA has mandated unexpectedly high testing requirements for a product in the safety and feasibility stage of development. The additional data requested by FDA may take us several months to obtain. We are escalating our concerns with the FDA decision by engaging the FDA’s ombudsman. However, there can be no assurance that this escalation will accelerate our development timelines.
Regulatory authorities in India have accepted this manufacturing change and, as a result, we will ship new cartridges to the site in India for use in our clinical trials there.
We have engaged a major testing lab, Battelle (Columbus, OH), to perform an in vitro study to examine the binding of the current Monkeypox strain to a miniature version of our Hemopurifier.
Financial Results for the Second Quarter Ended September 30, 2022

As of September 30, 2022, Aethlon Medical had a cash balance of approximately $19.6 million.

Consolidated operating expenses for the three months ended September 30, 2022 were approximately $3.67 million, compared to $2.14 million for the three months ended September 30, 2021. This increase of $1.53 million, or 71%, in the 2022 period was due to increases in our general and administrative expenses of $863,000, in our professional fees of $354,000 and in our payroll and related expenses of $307,000.

The $863,000 increase in our general and administrative expenses was primarily due to the combination of a $384,000 increase in our clinical trial expenses, a $258,000 increase in supplies, primarily for manufacturing Hemopurifiers, a $140,000 increase in subcontract expenses related to our government contracts, a $50,000 increase in our rent expense and a $32,000 increase in our insurance expense.

The $354,000 increase in our professional fees was primarily due to the combination of a $152,000 increase in our contract labor expense associated with product development and analytical services, a $136,000 increase in our legal fees and a $61,000 increase in our investor relations expenses, primarily related to solicitation expenses associated with our 2022 annual meeting of stockholders.

The $307,000 increase in our payroll and related expenses was due to an increase in our stock-based compensation expense of $112,000. Our cash-based compensation expense increased by $195,000 due to our increased headcount.

In September 2022, the Board of Directors of Exosome Sciences, Inc. (ESI) and Aethlon, as the majority stockholder of ESI, approved the dissolution of ESI. As a result of this dissolution, we recorded a non-cash charge of $142,121 as other expense in the three months ended September 30, 2022.

Aethlon did not record any revenue related to our government contract with the NIH in the three months ended September 30, 2022, compared to approximately $132,000 in the three months ended September 30, 2021. As of September 30, 2022, the Company had approximately $574,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts. The NIH award contract ended on September 15, 2022 and we presented the required final report to the NCI. Once the NCI completes the close out review of the contract, we expect to recognize as revenue the $574,000 currently recorded as deferred revenue on our September 30, 2022 balance sheet.

As a result of the changes in revenues and expenses noted above, our net loss increased to approximately $3.8 million in the three months ended September 30, 2022, from approximately $2.0 million in the three months ended September 30, 2021.

During the six months ended September 30, 2022, the Company raised approximately $8.9 million in net proceeds under our ATM agreement with H.C. Wainwright & Co., pursuant to sales of our common stock.

The unaudited condensed consolidated balance sheet for September 30, 2022, and the unaudited condensed consolidated statements of operations for the three and six months ended September 30, 2022 and 2021 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Monday, Nov.14, 2022, at 4:30 p.m. EST to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through December 14, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 2753791.

On November 14, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that it will present Phase 2 clinical results of ST101 in recurrent glioblastoma (GBM) during a poster session at the 27th Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 16-20, 2022 in Tampa Bay, Florida (Press release, Sapience Therapeutics, NOV 14, 2022, View Source [SID1234624052]).

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ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients in an ongoing Phase 2 study. These data will be presented in the ST101 poster at the SNO meeting.

More information is available on the SNO website.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the ongoing dose escalation part of the study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On November 14, 2022 Dewpoint Therapeutics Inc. reported the U.S. Patent and Trademark Office (USPTO) issued the patent "Methods of Characterizing Condensate-Associated Characteristics of Compounds and Uses Thereof" (U.S. Patent No. 11493519) covering novel technology for partitioning and identifying compounds which preferentially partition into condensates of interest (Press release, Dewpoint Therapeutics, NOV 14, 2022, View Source [SID1234624051]).

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Biomolecular condensates are molecular assemblies that form by a process called phase separation, similar to the separation of oil from water. Various condensates are known to be important for modulating cellular processes and regulating many diverse functions of the cell, from controlling biochemical reaction rates to compartmentalizing proteins and nucleic acids into orchestrated transcriptional machinery. Aberrant condensate function has also been linked to human diseases, including neurodegeneration and cancers. Condensate science holds broad promise for both understanding the origin of diseases and the discovery of breakthrough treatments.

Little has been known about the mechanisms governing the partitioning of compounds into condensates, how to design and test compounds to improve interactions with condensates, and how such information can be used to improve treatment of diseases.

Dewpoint’s issued patent is the first patented technology for measuring how a compound is entering or partitioning into a target condensate. This breakthrough technology will direct a compound to selectively target a single molecule in a condensate to alter disease.

"Dewpoint’s technology has broad implications for drug discovery and maximizing the effectiveness of medicines," said Isaac Klein, M.D., Ph.D., Chief Scientific Officer at Dewpoint. "It opens a new era of ‘condensate-targeted’ drug discovery by enabling us to direct a molecule to a condensate of interest. This can influence the activity of a drug by altering its local subcellular concentration, and thereby, its efficacy. It’s a new way of thinking about medicinal chemistry and lead optimization with the potential to improve drug efficacy."

In May 2022, Dewpoint was granted a foundational platform technology patent by the USPTO, for technology that identifies molecules which alter specific components of biomolecular condensates with high precision. Together, these patents claim technology that is critical for the discovery of new compounds that can be used to disrupt a condensate in a specific way to correct aberrant cellular functions and hold vast therapeutic potential.