On August 14, 2023 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 June 30, 2023, provided a corporate update and reiterates upcoming milestones (Press release, CNS Pharmaceuticals, AUG 14, 2023, View Source [SID1234634357]).

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"We are approaching the most important milestone to date since we launched CNS Pharma. We are just a few months away from reporting topline results from our Berubicin potentially pivotal study interim analysis and, although we do not know what the data looks like at this time, we remain hopeful as we also approach full enrollment of the trial," commented John Climaco, CEO of CNS Pharmaceuticals. "Looking ahead, we remain focused on executing on all of our operational efforts and importantly, taking our Berubicin trial for GBM across the finish line. We are poised for an exciting remainder of the year with significant milestones anticipated in the near term and look forward to optimizing our opportunities to build value for all shareholders in the near and long-term."

Recent Clinical Achievements

· Presented updated results from the on-going potentially pivotal study evaluating Berubicin in a poster presentation at the 2023 SNO/ASCO CNS Cancer Conference.
· Announced enrollment of 180 patients; The Company has opened 46 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland.
· Announced that the Company has reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board will review to determine whether to recommend continuing the study as planned based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma (GBM).
· Pace of enrollment is rapidly accelerating with the first 75 patients taking 18 months to enroll while the second 75 patients took less than 6 months to enroll.

Recent Corporate Achievements

·
Completed the initial phase of investigation with Shareholder Intelligence Services, LLC into potential naked short selling. As part of the investigation, the Company believes it was able to identify and eliminate the majority of the reported naked short selling activity, although there is no assurance the Company’s common stock will not experience such pressure in the future. The investigation is moving into its second phase of monitoring and taking further actions to continue to reduce the level of naked short selling.

Upcoming Expected Milestones for Potentially Pivotal Trial of Berubicin for GBM, in the order expected:

· Achieve enrollment of 200th patient in Q3 2023.
· Report topline results of interim analysis expected in Q4 2023.
· Complete enrollment in Q4 2023.

Summary of Financial Results for the Second Quarter 2023

The net loss for the three months ended June 30, 2023 was approximately $4.0 million compared to approximately $3.6 million for the comparable period in 2022. The change in net loss is attributable to an increase in research organization (CRO) expenses related to continued progress with the Company’s clinical trial, a credit to research and development expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $2.8 million for the three months ended June 30, 2023 compared to approximately $2.2 million for the comparable period in 2022. The increase in research and development expenses during the period were mainly attributed to the timing of CRO expenses related to continued progress with the Company’s clinical trial.

General and administrative expense was approximately $1.2 million for the three months ended June 30, 2023 compared to approximately $1.3 million for the comparable period in 2022. The decrease in general and administrative expense was mainly attributable to decreases of approximately $176,000 for employee compensation and taxes, $100,000 in legal and professional expenses, $22,000 in insurance expenses and $12,000 in other expenses, which were offset by increases of approximately $60,000 in marketing and advertising, $24,000 in board compensation and $39,000 in travel expenses.

As of June 30, 2023, the Company had cash of approximately $4.3 million and working capital of approximately $2.1 million. The Company’s current expectation is that the cash on hand is sufficient to fund operations into the fourth quarter of 2023, through the topline data readout for the Berubicin potentially pivotal study. The timing and costs of clinical trials are difficult to predict and trial plans and timing of milestones may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

On August 14, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce that its Phase 1 MAST (metastatic advanced solid tumours) trial evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has cleared the cohort 3 intratumoral (IT) arm of the monotherapy dose escalation study (Press release, Imugene, AUG 14, 2023, View Source [SID1234634298]).

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This allows Imugene to commence recruitment for IT cohort 4 of the monotherapy dose escalation, whereby VAXINIA will be administered in three-to-six patients.

Imugene MD & CEO Leslie Chong said: "We continue to rapidly advance our monotherapy dose while the combination study continues its positive progress. We remain incredibly eager to bring the results of this trial to our shareholders, patients and the wider public."

The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia.

The clinical trial is titled "A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST)." The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.

Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.

On August 12, 2023 Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative assets and biosimilars, reported positive Phase 1 clinical data for BAT8006 (Folate-Receptor-α-ADC) as part of a presentation of the clinical results of a Phase 1 dose escalation study evaluating the safety and efficacy of BAT8006 at the Bethune Obstetrics and Gynecology Forum in China (Press release, BioThera Solutions, AUG 12, 2023, View Source;adc-and-presents-phase-1-dose-escalation-study-at-the-bethune-obstetrics-and-gynecology-forum-301899142.html [SID1234634299]). BAT8006 is an antibody-drug conjugate (ADC) that is composed of an anti-FRα antibody and an ADC linker-payload combination that is composed of a proprietary cleavable linker that is highly systemically stable and a small molecule topoisomerase I inhibitor.

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As a co-principal investigator of the BAT8006 Phase 1 study that was performed at First Bethune Hospital of Jilin University, Professor Songling Zhang presented dose-escalation results from the study at the Bethune Obstetrics and Gynecology Forum. July 6, 2023 served as the cut-off date for the data presented at the conference. At that time twenty-nine (29) subjects with advanced solid tumors were recruited into four (4) dose cohorts (1.2 mg/kg, 1.8 mg/kg, 2.1 mg/kg and 2.4 mg/kg) in the dose-escalation study. FRα expression was not an eligibility criterion in the study and patients with multiple tumor types, such as ovarian cancer, breast cancer, non-small cell lung cancer (NSCLC) and cervical cancer, were include in the study. Ovarian cancer patients accounted for approximately 60% of the subjects in the study.

All twenty-nine (29) subjects enrolled in the study (regardless of tumor type) had at least one tumor assessment with an Overall Objective Response Rate (ORR) of 31.0% and a Disease Control Rate (DCR) of 86.2%. For the ovarian cancer subgroup fifteen (15) subjects were recruited in the 2.1 mg/kg and 2.4 mg/kg cohorts. Among the twelve (12) ovarian cancer subjects with TPS >25%, the ORR was 58.3% and the DCR was 91.7%. Based on FRα expression epidemiological studies, it is estimated that approximately 75% of ovarian cancer patients have FRα expression >25%. To be noted, most of these ovarian cancer patients had received ＞3 prior anti-tumor therapies that included bevacizumab and PARPi. In addition, two (2) subjects with non-ovarian tumors, including breast cancer and endometrial carcinoma, experienced partial responses.

BAT8006 demonstrated a manageable safety profile with the main treatment related adverse events (TRAEs) being hematological toxicity such as neutropenia, thrombocytopenia, anemia, and gastrointestinal toxicity, including nausea and vomiting. Safety issues such as interstitial lung disease, ocular toxicity and severe hepatotoxicity were not observed in the study and no subjects were withdrawn from the study due to TRAEs.

BAT8006 is currently being evaluated in a Phase 1b study in China with four dose expansion cohorts. Two different patient subgroups are being examined in the Phase 1b study. One patient subgroup consists of FRα-positive ovarian cancer patients while the second patient subgroup consists of FRα-positive patients with non-ovarian cancers. Two different doses of BAT8006 are being evaluated with each patient subgroup. Bio-Thera is also working to expand the BAT8006 clinical program to the United States and Europe.

About BAT8006

FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancer, etc., but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make FRα an attractive target for ADC drug development. BAT8006 was developed using Bio-Thera’s anti-FRα antibody and Bio-Thera’s proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong cell membrane penetration ability, so when the target cancer cells are killed, the payload can be released and further kill nearby cancer cells, producing a bystander effect which may effectively overcome the heterogeneity of the tumor.

BAT8006 is in the dose optimization and dose expansion studies. More subjects with ovarian cancer, endometrial cancer, NSCLC and breast cancers will be enrolled in the study to further evaluate the exposure-safety and exposure-efficacy response, which will support the final determination of recommended dose in Phase 2.

On August 11, 2023 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company focused on driving breakthrough innovation in the treatment of metastatic cancers to bone and soft tissue organs as well as osteologic interventions, reported the close of $9.79 million USD Series B funding round (Press release, Zetagen Therapeutics, AUG 11, 2023, View Source [SID1234643708]).

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"We are pleased to have reached this key milestone in the advancement of Zetagen as a biopharmaceutical company," said Joe C. Loy, CEO of Zetagen Therapeutics. "We have a robust and diverse pipeline of oncologic treatments in various stages of development and this funding will accelerate each asset, as well as build out the necessary expertise required to bring these important therapies to fruition."

The Company has been issued two Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for ZetaMet (Zeta-BC-003) and ZetaFuse and issued multiple patents from the U.S. Patent and Trademark Office (USPTO). Zetagen is funded through Series A and B rounds of funding, Phase I and II National Institute of Health (NIH) / National Cancer Institute (NCI) grants and angel investors.

The Series B financing will support the advancement of the Company’s lead pipeline asset ZetaMet (Zeta-BC-003) which is currently in Phase 2a clinical trials for the treatment of metastatic breast cancer bone lesions as part of advanced stage cancer therapy. In addition to ZetaMet (Zeta-BC-003), the funding will propel the development of ZetaMAST (Zeta-MBC-005) for the treatment of metastatic lesions to soft tissue organs, as well as other oncologic and osteologic pipeline assets. The Company will also add new talent to support these advancing programs.

"The work being done by Zetagen is aligned with our mission of supporting research which is potentially life-changing," said Nikhil Thakur, MD, Co-founder. "We believe the development of ZetaMet (Zeta-BC-003) and ZetaMAST (Zeta-MBC-005) – as well as the Company’s other clinical programs – have the potential to make a significant contribution to the treatment of late-stage cancers and more importantly, to the lives of those living with late-stage cancer."

Participating in the financing round were New York Ventures and Consolidated Capital Investments, LLC, and an amalgam of private investors.

On August 11, 2023 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company focused on driving breakthrough innovation in the treatment of metastatic cancers to bone and soft tissue organs as well as osteologic interventions, reported the close of $9.79 million USD Series B funding round (Press release, Zetagen Therapeutics, AUG 11, 2023, View Source [SID1234634293]).

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"We are pleased to have reached this key milestone in the advancement of Zetagen as a biopharmaceutical company," said Joe C. Loy, CEO of Zetagen Therapeutics. "We have a robust and diverse pipeline of oncologic treatments in various stages of development and this funding will accelerate each asset, as well as build out the necessary expertise required to bring these important therapies to fruition."

The Company has been issued two Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA) for ZetaMet and ZetaFuse and issued multiple patents from the U.S. Patent and Trademark Office (USPTO). Zetagen is funded through Series A and B rounds of funding, Phase I and II National Institute of Health (NIH) / National Cancer Institute (NCI) grants and angel investors.

The Series B financing will support the advancement of the Company’s lead pipeline asset ZetaMet which is currently in Phase 2a clinical trials for the treatment of metastatic breast cancer bone lesions as part of advanced stage cancer therapy. In addition to ZetaMet, the funding will propel the development of ZetaMAST for the treatment of metastatic lesions to soft tissue organs, as well as other oncologic and osteologic pipeline assets. The Company will also add new talent to support these advancing programs.

"The work being done by Zetagen is aligned with our mission of supporting research which is potentially life-changing," said Nikhil Thakur, MD, Co-founder. "We believe the development of ZetaMet and ZetaMAST– as well as the Company’s other clinical programs – have the potential to make a significant contribution to the treatment of late-stage cancers and more importantly, to the lives of those living with late-stage cancer."

Participating in the financing round were New York Ventures and Consolidated Capital Investments, LLC, and an amalgam of private investors.

About ZetaMet and ZetaMAST

ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone. The small molecule has been approved by the FDA since 1971. Zetagen scientists have discovered an entirely new pathway for this established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for patients living with metastatic bone lesions.

ZetaMAST is designed as a single, percutaneous, intra-tumoral injection, utilizing a proprietary hydrogel carrier containing a precise, tailored concentration of our small molecule. Preclinical studies have demonstrated ZetaMAST may cease lesion growth, with the goal of enabling improved quality of life as part of a cancer treatment program, including longevity.