On August 15, 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 June 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, AUG 15, 2022, View Source [SID1234618338]).

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"Within the past 6 months alone, we have executed on a number of clinical and operational advancements including expanding our global presence with clinical approvals in Spain, France and Switzerland to drive patient enrollment forward, as well as expanding eligibility for patients to participate in our potentially pivotal study of Berubicin for the treatment of GBM with our recently amended protocol, which was approved by the FDA, Swissmedic, National Agency for the Safety of Medicine and Health Products (ANSM) Competent Authority and corresponding European ethics committees. Our focus and priorities remain on advancing our clinical development program for Berubicin to ultimately bring a meaningful treatment to GBM patients, families and clinicians, who currently have extremely limited and often ineffective treatment options," commented John Climaco, CEO of CNS Pharmaceuticals.

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. Results from the trial will compare Berubicin to a current standard of care (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA previously granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

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;
Commencement of patient enrollment across European clinical sites;
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.
WP1244 Portfolio – Novel class of DNA-binding agents

The Company continues to advance the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. The Company’s development work has produced a new mesylate salt of WP1244, now identified as WP1874. The enhanced solubility of this salt may increase its ability to be formulated for use in an IV infusion, while maintaining similar potency and toxicity characteristics. Going forward, WP1874 will be the primary focus in our development efforts of the WP1244 portfolio. CNS Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.

Upcoming Milestones

File IND in 2023.
Summary of Financial Results for the Second Quarter 2022

The net loss for the three months ended June 30, 2022 was approximately $3.6 million compared to approximately $3.8 million for the comparable period in 2021. The change in net loss is attributable to decreases in 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 contract research organization (CRO) expenses related to continued progress with our Phase 2 clinical trial 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 June 30, 2022 compared to approximately $2.7 million for the comparable period in 2021. The decrease in research and development expenses during the period were mainly attributed to the timing of drug development expenses, 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 Phase 2 clinical trial.

General and administrative expense was approximately $1.3 million for the three months ended June 30, 2022 compared to approximately $1.1 million for the comparable period in 2021. This increase in general and administrative expense was mainly attributable to an increase in employee compensation (due to the timing of annual employee incentive compensation) and taxes and legal and professional fees, which were offset with decreases in stock-based compensation and other expenses.

As of June 30, 2022, the Company had cash of approximately $9.0 million and working capital of approximately $10.5 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 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 August 15, 2022 Carina Biotech reported that it has raised $7.5 million at first close of its current funding round, welcoming on board new venture capital business Tenmile as the cornerstone investor together with strong support from existing investors (Press release, Carina Biotech, AUG 15, 2022, View Source [SID1234618337]).

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"We are delighted to welcome Tenmile as an investor in Carina Biotech with its commitment to accelerate high impact, cutting edge Australian health technology innovation. We are also pleased that our other shareholders have continued their strong support," said CEO Dr Deborah Rathjen.

The capital raise enables Carina to complete its Investigational New Drug (IND) enabling studies and initiate a CAR-T clinical trial of our LGR5 CAR-T cell for patients with advanced colorectal (bowel) cancer.

"Colorectal cancer is Australia’s second deadliest cancer and its incidence is rising in people under the age of 50. Many younger people are diagnosed at advanced stages of the disease with very poor prognoses. This is a lethal cancer for all Australians, young and old, that we want to be able to treat. CAR-T therapy is currently used for the treatment of blood cancers and it has proved to be curative.

"We are very excited to be able to bring this personalised form of immunotherapy embedded with Carina’s proprietary CAR-T technology to patients with solid cancers," Dr Rathjen further added.

Tenmile Executive Chair, Dr Steve Burnell, said, "Carina represents the kind of investment opportunity Tenmile looks for – advanced novel technology addressing a major unmet medical need, depth of expertise, global networks and strong intellectual property. It also reflects our commitment to using our capital as a force
for good including backing female-led businesses."

Carina is one of Tenmile’s first cohort of investments. Tenmile is the new $250m healthtech venture capital fund backed by Andrew and Nicola Forrest’s Tattarang investment group.

The capital raise also enables Carina to progress its robust pipeline of CAR-T programs and its technology platform which includes Carina’s Chemokine Receptor Platform that is being used to develop CAR-T cells expressing chemokine receptors that drive CAR-T cells to ‘home in’ on specific cancer cells.

Carina’s proprietary manufacturing process shortens the time required for CAR-T cell generation producing higher numbers of highly active CAR-T cells.

Carina’s approach to institutional and impact investors was undertaken by MST Financial. Peter Wilson of wilsonemmett Pty Ltd acted as financial adviser to Carina.

On August 15, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the quarter ended June 30, 2022 (Press release, Moleculin, AUG 15, 2022, View Source [SID1234618320]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"The first half of this year has been marked by demonstrated execution resulting in clinical progress, and importantly, continued compelling safety and efficacy data across our development pipeline. As we look to the remainder of the year, we are committed to operational excellence, driving our clinical programs forward and meeting our expected data readout timelines. Based on the progress and positive data demonstrated to date, we believe we are well positioned to continue to execute on our clinical milestones and potentially offer solutions for patients across a number of indications," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

Recent Highlights

Announced the conclusion of the Phase 1b portion of its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (STS lung mets) and opened recruitment for the Phase 2 portion of the trial.

Received allowance to proceed with Phase 1/2 study of Annamycin in combination with Cytarabine for the treatment of Acute Myeloid Leukemia (AML).

Commenced dosing in the Phase 1a clinical trial evaluating WP1122 in healthy volunteers in the United Kingdom (UK) for the treatment of COVID-19 and announced the completion of the first and second single ascending dose (SAD) cohorts with preliminary results allowing the Company to proceed to 32 mg/kg dose of WP1122 in the third cohort toward establishing maximum tolerated dose (MTD).
Programs Update

Next Generation Anthracycline – Annamycin

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases and the Company believes it may have the potential to treat additional indications.

STS Lung Mets

The Company recently announced completion of its Phase 1b portion of the U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of STS lung mets. Preliminary results from the study continue to document clinical activity for Annamycin in the treatment of STS. The safety review committee (SRC) deemed the dose of 390 mg/m2 to be safe after conclusion of the fourth cohort. Consistent with the recommendation of the SRC, the Company determined that the RP2D will be 360 mg/m2 for the first three subjects in the Phase 2 portion of the study, for which screening has begun. For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

AML

The Company received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) in the treatment of subjects with AML who are refractory to or relapsed after induction therapy. The Phase 1/2 AnnAraC trial (MB-106), an open label trial, builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials (MB-104 and MB-105) in the U.S. and Europe, respectively, and the preclinical data from the Company’s sponsored research studies.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug and Fast Track Designation for the treatment of relapsed or refractory acute myeloid leukemia.

Upcoming Milestones Expectations

Q3 2022: Commence enrollment in Phase 1/2 study of Annamycin in combination with Ara-C in Acute Myeloid Leukemia.

H2 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.

H2 2022: Report Phase 2 interim data from ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.
Metabolism/Glycosylation Inhibitor – WP1122 Portfolio

WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses.

COVID-19

The Company is currently evaluating WP1122 in an ongoing Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD (Multiple Ascending Dose) clinical trial investigating the effects of WP1122 administered as an oral solution in healthy human volunteers. It is the first step in a planned investigation of WP1122 for the treatment of COVID-19. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has successfully completed at least 3 dosing cohorts. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development is expected to be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 subjects in this trial.

The Company’s first completed SAD cohort consisted of 9 subjects dosed with 8 mg/kg or placebo in the dose escalation trial. Based on the overall results in Cohort 1, the safety review committee (SRC) deemed the first cohort dose safe and well-tolerated. The Company’s second completed SAD cohort consisted of 8 subjects dosed with 16 mg/kg or placebo in the dose escalation trial. Based on the overall results in Cohort 2, the SRC deemed the cohort dose safe and well-tolerated and began its SAD Cohort 3 with a dose escalation to 32 mg/kg.

While the Company is in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies might occur, the volatility and unpredictability of COVID-19 incidence in various countries may limit the ability to recruit certain subjects and could make it infeasible to conduct a Phase 2 clinical trial. Importantly, however, the safety and tolerability data from this Phase 1 trial will also enable the initiation of future clinical trials in cancer indications.

Glioblastoma Multiforme

Additionally, Moleculin recently received IND clearance from the FDA to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM, which the Company expects to commence in 2022.

Upcoming Milestones Expectations

H2 2022: Topline data from Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.

H2 2022: Potential to launch Phase 2 study of WP1122 for the treatment of COVID-19 outside of the US.

2022: Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

Ongoing preclinical development work, including other molecules in the WP1122 Portfolio in additional anti-viral indications such as HIV, Zika, and hemorrhagic fever viruses. Collaborations targeted for 2022.
Summary of Financial Results for the Second Quarter 2022

Research and development (R&D) expense was $4.2 million and $3.0 million for the three months ended June 30, 2022 and 2021, respectively. The increase of $1.2 million is mainly related to increased clinical trial activity as described above, and costs related to manufacturing of additional drug product.

General and administrative expense was $3.2 million and $2.4 million for the three months ended June 30, 2022 and 2021, respectively. The increase of $0.8 million is mainly related to an increase in regulatory and legal services.

For the six months ended June 30, 2022 and 2021, the Company incurred net losses of $13.6 million and $8.7 million, respectively, and had net cash flows used in operating activities of $12.8 million and $10.4 million, respectively

The Company ended the quarter with $58.0 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, beyond mid-2024.

On August 15, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug-development company focused on DNA-mediated immunotherapy and next-generation vaccines, reported financial results for the three and six months ended June 30, 2022, and provided an update on its clinical development program of GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development for the treatment of advanced-stage ovarian cancer, and its preclinical studies of PLACCINE, a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral delivery vectors, being evaluated in proof of concept studies for superiority over current mRNA vaccines (Press release, Celsion, AUG 15, 2022, View Source [SID1234618319]).

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"As we approach the second half of the year, I am pleased to report that Celsion is in a strong financial position, making important progress with our innovative development platforms in oncology and infectious disease. Our OVATION 2 Phase II study of GEN-1 in advanced ovarian cancer continues to advance, with complete enrollment anticipated in the third quarter. Our PLACCINE platform, which was highlighted at the recent World Vaccine Forum, continues to show promise for the potential to address a range of infection diseases as we evaluate its capability in a head to head comparison with commercial covid-19 vaccines," said Dr. Corinne Le Goff, Celsion’s president and chief executive officer. "Moreover, given the uncertainty of the capital markets, it’s clear that the steps that we have taken over the past 18 months to ensure a cash balance that provides a runway into 2025 was a smart strategy. We expect to report several value creating developments during this time frame."

Recent Developments

GEN-1 Immunotherapy

Data Safety Monitoring Board Unanimously Recommends Continued Dosing Patients in the OVATION 2 Study. In June 2022, the Company announced that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in the control arm) randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety was satisfactory with an acceptable risk/benefit, and that weekly doses of GEN-1 were well tolerated during a course of treatment that is given over six months in combination with standard neoadjuvant chemotherapy. No dose-limiting toxicities were reported.

The Company also announced that more than 87% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from patients who have undergone interval debulking surgery showed that the GEN-1 treatment arm is showing improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores over the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.

In February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.

Findings from the Use of a Synthetic Control Arm to Estimate Treatment Effect in Phase Ib dose-escalating OVATION I Study presented at 2022 AACR (Free AACR Whitepaper) Annual Meeting. In April 2022, Celsion demonstrated its commitment to innovation in clinical research. The Company and the premier global data management CRO, Medidata, announced findings on the use of a Synthetic Control ArmⓇ (SCA) in a completed Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). In a poster presentation entitled "Phase IB trial efficacy estimates via a clinical trial synthetic control arm," which took place on Monday April 11, 2022, the research team’s findings demonstrated how comparing patients from a single-arm trial can help enhance understanding of treatment effects in advance of randomized trials, inform drug development and trial design, and increase the scientific value of early phase trials.

A Synthetic Control Arm is a type of external control and is formed by carefully matching patients treated with a new investigational therapy to anonymized clinical trial patients from Medidata’s extensive repository of historical clinical trials using baseline demographic and disease characteristics. Using this advanced statistical methodology, Celsion and Medidata found that progression-free survival was prolonged for the patients treated with the investigational therapy GEN-1 along with standard of care chemotherapy in the OVATION 1 Study compared to well-balanced historic control patients treated with the same standard of care chemotherapy alone (Hazard Ratio=0.53, 95% Confidence Interval (0.16, 1.73). This larger than expected effect size led to a decrease in the number of planned patients for Celsion’s subsequent Phase II trial and was used in support of Fast Track Designation from the U.S. Food and Drug Administration (FDA) received in February 2021.

Vaccine Initiative

PLACCINE Vaccine Platform Technology Highlighted During Oral Presentation at the World Vaccine Congress. In April 2022, the Company presented its PLACCINE platform technology at the World Vaccine Congress which took place in Washington D.C. In an oral presentation during a Session on Cancer and Immunotherapy, Dr. Khursheed Anwer, Celsion’s Chief Science Officer, highlighted the Company’s technology platform in his presentation entitled: "Novel DNA Approaches for Cancer Immunotherapies and Multivalent Infectious Disease Vaccines." PLACCINE is one of three platform technologies Celsion has for a range of therapeutics in oncology and immunotherapy. A copy of Dr. Anwer’s presentation is available on the investor portion of the Celsion website under Scientific Presentations.

PLACCINE is demonstrating the potential to be a platform for a range of infectious disease that provides for rapid design capability for targeting two or more different variants of a single virus in one vaccine. There is a clear public health need for vaccines today that address more than one strain of viruses, like COVID-19, which have fast evolving variant capability. Murine model data has thus far been encouraging and suggests that the Company’s approach provides not only flexibility, but also the potential for efficacy comparable to benchmark COVID-19 commercial vaccines with durability to protect expected to be greater than 6 months.

In the murine model, our multivalent PLACCINE vaccine targeted against two different variants showed to be immunogenic as determined by the levels of IgG, neutralizing antibodies, and T-cell responses. Additionally, our multivalent vaccine was equally effective against two different variants of the COVID-19 virus while the commercial mRNA vaccine appeared to have lost some activity against the newer variant. The Company continues to evaluate our technology and look forward to the results from our ongoing proof-of-concept non-human primate study evaluating our PLACCINE vaccine against the challenge from live SARS-CoV-2 virus in the second quarter, with durability results available in the second half of this year.

Corporate Developments

Dr. Corinne Le Goff Appointed as President and Chief Executive Officer; Michael H. Tardugno Appointed Executive Chairman of the Board. In July 2022, the Company announced that the Company’s Board of Directors appointed biopharmaceutical leader Corinne Le Goff, Pharm D, MBA, as President and Chief Executive Officer and Director, effective July 18, 2022. Michael H. Tardugno will continue to serve as Executive Chairman of Celsion’s Board of Directors.

Dr. Le Goff brings decades of global healthcare leadership experience to the Company across a range of therapeutic areas including oncology, vaccines, immunology, CNS and cardio-metabolism. She brings a wealth of experience in developing and launching successful drugs from her tenure at both large pharmaceutical companies and small, innovative biotech companies.

Prior to her Celsion appointment, Dr. Le Goff most recently served as the Chief Commercial Officer of Moderna, responsible for developing the global presence and capabilities necessary to ensure the global distribution of Moderna’s COVID-19 vaccine. She also led the development of the Moderna’s mRNA platform long-term commercial strategy. Dr. Le Goff joined Moderna from Amgen, where she served as President of the U.S. Business, driving the growth strategy with increased contributions from Repatha and Aimovig. During her 6-year tenure at Amgen, she also served as Senior Vice President of Global Product Strategy & Commercial Innovation and as President of the Europe Region overseeing 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality, and affordable healthcare. She represented Amgen as a member of the Healthcare Leadership Council. Prior to joining Amgen, Dr. Le Goff held a number of senior international roles at Roche, including President of Roche France, a major affiliate of the Roche Group, and Global Product Strategy Head of Neuroscience & Rare Diseases. Early in her career, Dr. Le Goff spent 11 years in various leadership roles at Sanofi and Pfizer in the United States.

Dr. Le Goff earned a PhD in pharmaceutical sciences from Rene Descartes University in Paris and an MBA from Sorbonne University and INSEAD. She also holds qualifications from Northwestern University and the Hong Kong University of Science and Technology. She received the distinction of being named a Chevalier de la Légion d’Honneur in 2014. She holds a U.S. patent and was recently recognized by Forbes Magazine as one of the women over the age of 50 who are changing the world.

Strengthened Balance Sheet Through Registered Direct Offering of Common Shares totaling $7.0 Million in Gross Proceeds Priced At-The-Market under NASDAQ Rules. On April 8, 2022, the Company announced the closing of a registered direct offering of 1,328,274 shares of common stock at a purchase price of $5.27 per share, resulting in gross proceeds of $7.0 million, before deducting placement agents’ fees and expenses. Celsion intends to use the net proceeds for general corporate purposes, including research and development activities, capital expenditures and working capital.

Second Quarter Financial Results

Celsion reported a net loss for the second quarter of 2022 of $6.0 million ($0.87 per share) compared with a net loss of $5.4 million ($0.95 per share) in 2021. Operating expenses were $6.1 million for the second quarter in 2022, which represented a $0.9 million (17%) increase from $5.2 million for the second quarter of 2021.

The Company ended the second quarter of 2022 with $48.1 million in cash, investments, restricted cash, and accrued interest receivable. Coupled with future planned sales of the Company’s State of New Jersey net operating losses, the Company believes it has sufficient capital resources to fund its operations into 2025.

Research and development expenses were $3.2 million for the second quarter of 2022, an increase of $0.6 million or 23% from $2.6 million for the comparable period in 2021. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA vaccine technology platform increased to $1.7 million in the second quarter of 2022 compared to $1.4 million in the same three-month period of 2021. Costs associated with the OPTIMA Study were $0.5 million in the second quarter of 2022 which represented expenses associated with closing out this Phase III study which was discontinued in the first quarter of 2021. In July 2020, the Company unblinded the OPTIMA Study at the recommendation of the DMC to halt the study due to futility. Other clinical, CMC and regulatory costs were $1.0 million in the second quarter of 2022 and 2021.

General and administrative expenses were $2.9 million in the second quarter of 2022, compared with $2.6 million in the same period of 2021. This $0.3 million increase was primarily attributable to higher professional fees (largely legal fees to defend various suits filed after the announcement in July 2020 of the OPTIMA Phase III clinical results) and higher premiums for directors’ and officers’ insurance offset by lower non-cash stock compensation expense.

Other non-operating expenses were $65 thousand in the second quarter of 2022 compared to $0.4 million in the comparable prior year. This decrease was attributable to the payment of early termination fees to Horizon Technology Finance Corporation in June 2021. The Company entered into a $10 million loan facility with Silicon Valley Bank (SVB). The Company immediately used $6 million from the SVB facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation. In connection with the termination of the Horizon Technology Financing Facility in the second quarter of 2021, the Company paid early termination and end of term charges to Horizon and recognized $0.2 million as a loss on early debt extinguishment.

Financial Results for the Six Months Ended June 30, 2022

For the six months ended June 30, 2022, the Company reported a net loss of $16.5 million ($2.59 per share), compared with a net loss of $11.1 million ($2.19 per share) in the same period of 2021. Operating expenses were $12.1 million during the first six months of 2022, which represented a $1.4 million (13%) increase from $10.7 million in the same six-month period of 2021.

Net cash used for operating activities was $13.4 million in the first six months of 2022, compared with $7.3 million in the same period in 2021. This increase was primarily due to the one-time payment of $4.6 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022. The Company’s projected cash utilization for the balance of 2022 is approximately $5 million per quarter. Cash provided by financing activities of $6.3 million during the first six months of 2022 was derived from an at-the-market equity offering in April 2022. The Company also received net proceeds of $1.4 million from the sale of its unused New Jersey NOLs in February 2022.

Research and development expenses increased $1.1 million to $6.3 million in the first six months of 2022 from $5.2 million in the comparable prior-year period. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA technology platform increased to $3.7 million in the first six months of 2022, compared with $2.8 million in the comparable 2021 period. Costs for the Phase III OPTIMA Study increased $0.1 million to $0.5 million in the first six months of 2022, compared with $0.4 million in the first six months of 2021, due to closing out this Phase III study which was discontinued in the first quarter of 2021. Other costs related to clinical supplies and regulatory support for the Company’s clinical development programs increased $0.1 million in the first six months of 2022, compared with the same prior year period.

General and administrative expenses were $5.7 million in the first six months of 2022, compared with $5.5 million in the same period of 2021. The $0.2 million increase was primarily attributable to higher legal and professional fees offset by lower non-cash stock compensation expense.

Other non-operating expenses were $4.7 million in the first six months of 2022 compared to $0.7 million in the comparable prior year period. This increase was attributable to the one-time payment of $4.6 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022.

Conference Call

The Company is hosting a conference call to provide a business update, discuss second quarter 2022 financial results and answer questions at 11:00 a.m. EDT today. To participate in the call, interested parties may dial 1-888-220-8451 (Toll-Free/North America) or +1-323-794-2588 (International/Toll) and ask for the Celsion Corporation Second Quarter 2022 Earnings Call (Conference Code: 5801156) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Monday, August 15, 2022, and will remain available until August 29, 2022. The replay can be accessed at +1-719-457-0820 or 1-888-203-1112 using Conference ID: 5801156. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Monday, August 15, 2022.

On August 15, 2022 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2022 (Press release, Galectin Therapeutics, AUG 15, 2022, View Source [SID1234618318]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President, stated: "Our team made significant progress on a number of fronts this quarter. The most consequential action for the Company undoubtedly was finalizing a $60 million line of credit facility from Richard Uihlein. Proceeds from this very favorable financing arrangement are expected to cover all our currently projected costs for the Phase 2b portion of our NAVIGATE trial. Once again, I want to express my gratitude to Mr. Uihlein for his dedication to and belief in the Company. His unwavering commitment clearly has provided the resources necessary for the successful completion of our global pivotal clinical trial.

"Additionally, our team is making substantial progress in completing an Investigational New Drug (IND) package, including the development of a phase 2 trial protocol. The Company’s objective is to file an IND with the Food and Drug Administration (FDA) Office of Oncologic Diseases (OOD) for the treatment of recurrent or metastatic head and neck cancer for belapectin in combination with Keytruda, an immune checkpoint inhibitor. We will have more updates as they become available. Finally, we are looking forward to completion of enrollment of the phase 2b portion of our NAVIGATE clinical trial."

Dr. Pol Boudes, Chief Medical Officer, stated: "The COVID-19 pandemic impacted enrollment timelines for many clinical trials over the past couple of years and we, as well as other NASH study sponsors, are no exception. In response to continuing challenges, particularly in Europe and Australasia, we initiated multiple new sites in Mexico and South America. We have been pleased, thanks to assistance from local partners, to see a rapid acceptance of our program by Health Authorities and Ethics Committees. Our investigators meeting in Mexico gathered 15 new sites and gave us a unique opportunity to judge the gravity of the NASH epidemy in this country. As a result of these actions, we now have multiple sites that started to screen patients. I have also personally visited multiple sites and investigators over the past few months, in addition to meeting with several more at the International Liver Conference, this June in London, UK. We continue to receive consistent and supportive feedback from our investigators regarding the importance and uniqueness of NAVIGATE and the potential to bring to patients with cirrhosis and portal hypertension a therapy for this large unmet medical need. We have now randomized 230 patients with an additional 70 patients currently in screening. We expect enrollment to be completed in the fourth quarter of this year."

Financial Results

For the three months ended June 30, 2022, the Company reported a net loss applicable to common stockholders of $9.7 million, or ($0.16) per share, compared to a net loss applicable to common stockholders of $8.5 million, or ($0.15) per share for the three months ended June 30, 2021. The increase is largely due to an increase in 2022 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended June 30, 2022, was $8.1 million compared with $6.5 million for the three months ended June 30, 2021. The increase was primarily due to costs related to the NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2022, were $1.6 million, compared to $1.7 million for the three months ended June 30, 2021. The decrease was primarily due to a decrease in investor relations/business development expenses.

As of June 30, 2022, the Company had $24.2 million of cash and cash equivalents. The Company believes it has sufficient cash, including availability under its new $60 million line of credit, to fund currently planned operations and research and development activities through at least December 31, 2024.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis," began enrolling patients in June 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.