On November 15, 2022 QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam), for the treatment of bone cancer and related diseases, reported financial results for the third quarter ended September 30, 2022, as filed with the SEC on November 14, 2022 in the Company’s Form 10-Q, and provides a corporate update (Press release, QSAM Biosciences, NOV 15, 2022, View Source [SID1234624088]).

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Recent Corporate Highlights:

●Second patient dosed in Phase 1 clinical trial; data continues to demonstrate preliminary positive results. Completion of the initial cohort grouping of patients is expected in the fourth calendar quarter.
●Rutgers Cancer Institute of New Jersey (RCINJ) has been added as a clinical trial site to begin enrolling patients; expected to help accelerate pace of study and add key expertise.
●Approximately $1 million was raised in a common stock / warrant private placement during third quarter.

"Initial, preliminary data from our second patient dosed with CycloSam continues to show positive signals in terms of safety and efficacy. While it is too early for formal conclusions to be made of these results, CycloSam generally performed how we expected it to perform, even given the lowest dosage in our dose-escalating study. This is all very encouraging," stated Douglas R. Baum, CEO and co-founder of the Company.

"We expect the pace of our clinical trials to accelerate in the fourth quarter of 2022 and into 2023. This is partly due to the onboarding as a trial site the highly-regarded Rutgers Cancer Institute of New Jersey, which is a National Cancer Institute (NCI) – designated Comprehensive Cancer Center that treats a significant population of patients who could potentially qualify for our study. We have also been able to raise equity funding on favorable terms from supportive investors who share our long-term vision for QSAM. Our team continues to work towards creating shareholder value in conjunction with our most important mission to help adult and pediatric patients suffering from bone cancer," added Baum.

Summary Financial Results for the Quarter Ended September 30, 2022:

(All numbers except shares are approximated)

For the three months ended September 30, 2022, we recorded a net loss of $1.23 million, an increase of $0.18 million from our net loss of $1.05 million for the same period in 2021. Our operating expenses were $1.21 million for the third quarter of 2022 as compared to $1.20 million in the 2021 period. The slight increase in operating expenses was largely due to an increase in compensation and related expenses of $0.23 million, an increase in research and development expenses of $0.08 million, and an increase in general and administrative expenses of $0.07 million, offset by a decrease in professional fees of $0.36 million in the three months ended September 30, 2022.

Net loss attributable to common stockholders for the third quarter of 2022 was $1.28 million as compared to $1.92 million for the 2021 period. The net loss attributed to common stockholders includes Series A and Series B preferred contractual dividends and deemed dividends. The net loss attributable to common stockholders, basic and diluted, for the three months ended September 30, 2022 was a loss of $0.75 per share as compared to a loss of $2.45 per share for the 2021 period.

As of September 30, 2022, we had cash on hand of $899,290, primarily from the closing of the first tranche of a common stock and warrant private placement.

As of November 10, 2022, the Company had 1,922,142 common shares outstanding, which includes the issuance of 205,556 shares in the quarter in connection with a private placement and 30,000 shares for a services contract. At the end of the second quarter of 2022 there were approximately 705,419 shares of common stock that could be issued upon the conversion of preferred stock, warrants and convertible debt, excluding employee stock options.

The following tables summarize our results of operations for the periods indicated, and are qualified in their entirety by the Company’s Form 10-Q for the period ended September 30, 2022, filed with the SEC on November 14, 2022, including the financial footnotes contained therein:

On November 15, 2022 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three and nine months ended September 30, 2022 and provided a business update (Press release, Athersys, NOV 15, 2022, View Source [SID1234624087]).

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"Our restructuring initiative is now largely complete and has yielded significant expense savings and a streamlined organization"

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Third quarter 2022 Corporate and Operational Highlights:

Corporate Restructuring

Raised gross proceeds of $12.0 million in a registered direct offering with a U.S. healthcare-focused institutional investor and, following the close of the quarter, raised an additional $5.5 million in gross proceeds in a best efforts public offering
Executed a 1-for-25 reverse stock split to bring Athersys into compliance with Nasdaq’s minimum bid price continued-listing requirement
Largely completed restructuring initiative with the goal of significantly reducing expenses, conserving cash, improving focus and increasing attractiveness to financial and strategic partners
Suspended certain high-cost manufacturing and process-development initiatives
Initiated efforts to sublet the Stow, Ohio facility
Paused work at the ReGenesys animal health-focused division in Belgium, leased half the facility and identified potential opportunities to license related patents
Reduced and streamlined internal research function to focus resources on MASTERS-2
Business Development Strategy

Participated in several industry conferences to build awareness of Athersys and MultiStem, including:
4th World Stroke Congress
2022 Cell & Gene Meeting on the Mesa
Pursuing a business development strategy focused on securing regional and/or global MultiStem partners, non-dilutive funding and complementary capabilities across clinical, regulatory, commercial and manufacturing functions
Held a webinar to review preclinical research across multiple indications with MultiStem hosted by Dr. Willie Mays, Executive Vice President and Head of Regenerative Medicine & Neuroscience Programs, and Dr. Sarah Busch, Vice President, Regenerative Medicine & Head of Nonclinical Development
Announced preclinical research by the Armed Forces Radiobiology Research Institute showing the benefit of MultiStem in an animal model of acute radiation syndrome
Transferred MultiStem manufacturing rights to Healios to support their clinical work in acute respiratory distress syndrome (ARDS) and stroke
Third Quarter MultiStem Clinical Trial Updates

MASTERS-2 (Phase 3 global study in ischemic stroke)

Doubled the average number of patients enrolled per month in 2022 from prior years
Expanded the network of active trial sites by adding new locations including key stroke centers in Germany, the UK, Taiwan and Australia
Analyzed TREASURE clinical trial results for potential read through to MASTERS-2 trial design
MATRICS-1 (Phase 2 study in trauma)

Collaborating with The University of Texas Health Science Center at Houston, one of the busiest Level 1 trauma centers in the U.S.
Initiated dosing with product derived from Athersys’ large-scale bioreactors, providing greater scalability and efficiency
Working to facilitate subject enrollment in the trial without the need to secure prior patient consent
Management Commentary

"Our restructuring initiative is now largely complete and has yielded significant expense savings and a streamlined organization," said Dan Camardo, Chief Executive Officer of Athersys, "Enrollment in our MASTERS-2 clinical trial has stepped up considerably and we continue to seek strategic partnership opportunities to advance our MultiStem platform and provide non-dilutive funding."

Third Quarter Results

Revenues for the third quarter of 2022 were $0.1 million compared to $4.8 million for the he third quarter of 2021. Collaboration revenues fluctuate from period to period based on the delivery of services under the arrangement with Healios. As of September 30, 2022 and during the third quarter of 2022, the services under the Healios arrangement are largely complete and are limited to close-out activities.

Research and development expenses were $12.4 million for the third quarter of 2022 compared with $17.2 million for the comparable period in 2021. The decrease is due to reduced salaries and benefits of $2.0 million, internal research supplies of $1.6 million, manufacturing costs of $0.2 million, outside services of $0.6 million and decreases in other research and development costs of $0.4 million. The Company expects research and development expenses to decrease in connection with its restructuring plan.

General and administrative expenses were $3.7 million for the third quarter of 2022, compared with $3.6 million for the comparable period in 2021. The increase is primarily related to restructuring costs. We expect our general and administrative expenses to decrease in connection with our restructuring plan.

Net loss for the third quarter of 2022 was $13.7 million, or $1.15 per share, compared to a net loss of $16.2 million, or $1.76 per share, for the third quarter of 2021.

During the nine months ended September 30, 2022, net cash used in operating activities was $47.0 million compared to $56.9 million in the nine months ended months September 30, 2021. At September 30, 2022, we had $13.8 million in cash and cash equivalents, compared to $37.4 million at December 31, 2021.

Conference Call

Athersys will host a conference call today at 11:00 a.m. Eastern time to discuss these results and answer questions. Stockholders are encouraged to listen using this Webcast link. To participate via phone if you intend to ask a question, please pre-register for the conference call using this Call registration link. Registered stockholders will receive the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Stockholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 p.m. Eastern Time on November 22, 2022, by dialing (888) 330-2506 or (240) 789-2712 and entering the conference code 70781.

On November 15, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that the first patient has been dosed in a Phase I/II clinical trial designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors (Press release, Enlivex Therapeutics, NOV 15, 2022, View Source [SID1234624086]).

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Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex, stated "Our team is continuing to focus on execution of our strategic and operating plan across our various clinical development verticals, with an ongoing sepsis Phase II clinical trial and two ongoing oncology Phase I/II clinical trials. We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to observing safety and potential indication of effect in patients, who we expect to enroll in our open-label oncology trials during 2023.

ABOUT THE PHASE I/II TRIAL

The Phase I/II trial is a multicenter, open-label, dose escalation trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the trial will examine escalating doses of Allocetra monotherapy administered intravenously (IV) or intraperitoneally (IP) once a week for three consecutive weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1 therapy. Patients in Stage 2 will receive three injections of Allocetra concomitantly with the studied anti-PD1 agent. The primary objective of the study is to evaluate safety and tolerability throughout the treatment period and through one week after the last administration of Allocetra. Key secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed as an exploratory endpoint. The study population encompasses adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for, or have declined additional standard-of-care systemic therapy.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On November 14, 2022, at the request of the FDA, Clovis Oncology, Inc. (the "Company") met by teleconference with the FDA to discuss the overall survival (OS) data from the Company’s ARIEL3 clinical trial (Filing, Clovis Oncology, NOV 14, 2022, View Source [SID1234624529]). The ARIEL3 dataset formed the basis for the approval of Rubraca in the US in April 2018 and in Europe in January 2019 respectively, as second-line maintenance treatment in adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The Company submitted final OS data, including in exploratory subgroups, from the ARIEL3 study to the FDA in September 2022. The FDA requested that the Company voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment to tBRCA patients only. The FDA further indicated to the Company that if an agreement could not be reached on the revised indication, the FDA would convene an ODAC meeting to review this matter. The Company is currently evaluating FDA’s request.

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CASI Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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