On November 15, 2021 Kintara a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal first quarter ended September 30, 2021 and provided a corporate update (Press release, Kintara Therapeutics, NOV 15, 2021, View Source [SID1234595587]).

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CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

Positioned our management team for our next stage of development by announcing that Robert E. Hoffman, our current Chairman, succeeded Saiid Zarrabian as our President and Chief Executive Officer. Mr. Hoffman will continue in his capacity as our Chairman and Mr. Zarrabian has transitioned to heading up our strategic partnerships initiative and will remain a member of our Board of Directors (November).
Activated additional clinical trial sites for glioblastoma (GBM) patients for the VAL-083 arm of the GBM AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). There are over 26 activated clinical sites (August).
Reported topline results from the Phase 2 study conducted at the MD Anderson Cancer Center that affirm the safety and efficacy of VAL-083 in two different GBM patient subtypes and support continued evaluation of VAL-083 in the GBM AGILE registrational study.
Topline Phase 2 clinical study results for VAL-083 as adjuvant therapy for newly-diagnosed GBM patients were reported demonstrating progression free survival and overall survival of 10.0 months and 16.5 months, respectively, in efficacy evaluable patients (September).
Topline Phase 2 clinical study results for VAL-083 for recurrent GBM were reported demonstrating median overall survival of 8.0 months for the 48 efficacy evaluable patients initially receiving the GBM AGILE treatment dose of 30 mg/m2/day (July).
Entered into securities purchase agreements with healthcare-focused institutional investors to raise approximately $15.0 million in gross proceeds. Funding from this registered direct offering provides cash for ongoing clinical studies and corporate working capital needs (September).
Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of the 15-patient confirmatory study. Enrollment of first patient is expected in the second quarter of calendar 2022.
"Our focus this past quarter was purely on executing the clinical strategy for VAL-083, our first-in-class, potentially transformational therapy for multiple oncology indications, and REM-001, our late-stage photodynamic therapeutic platform," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "I’m particularly pleased to report that we have exceeded our expectations regarding the pace of enrollment for the GBM AGILE study and as such, remain confident that we’ll meet the goal of advancing to the final registration stage of the study in the third quarter of calendar 2022."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2022 FIRST QUARTER ENDED SEPTEMBER 30, 2021

At September 30, 2021, the Company had cash and cash equivalents of approximately $19.3 million. For the three months ended September 30, 2021, the Company reported a net loss of approximately $6.0 million, or $0.25 per share, compared to a net loss of approximately $19.5 million, or $1.33 per share, for the three months ended September 30, 2020. The decrease in the net loss for the three months ended September 30, 2021 compared to the three months ended September 30, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. in August 2020.

On November 15, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S (Press release, Coherus Biosciences, NOV 15, 2021, View Source [SID1234595586]). The designation provides incentives to advance development and commercialization of rare disease drugs.

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Esophageal cancer ("EC") is a malignant tumor originating in the inner lining of the esophagus. Esophageal squamous cell carcinoma ("ESCC") and adenocarcinoma are the two main subtypes of esophageal cancer. EC is rare in the United States, with approximately 19,000 newly diagnosed cases and 15,000 deaths annually, according to estimates from the American Cancer Society. The prognosis of patients with advanced EC is poor, with five-year survival rates of less than 20%.

"Esophageal squamous cell carcinoma is an aggressive cancer, and patients need new and better treatment options. We plan to work closely with our partner, Junshi Biosciences, to submit a BLA supplement for toripalimab for this indication in 2022," said Denny Lanfear, CEO of Coherus.

In September, Coherus and Junshi Biosciences announced results of the Phase 3 clinical trial, JUPITER-06, a randomized, double blind, placebo-controlled study evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic ESCC. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination, compared to chemotherapy alone. In 2022, Coherus and Junshi Biosciences are planning to submit a biologics license application ("BLA") supplement to the FDA for toripalimab in combination with platinum-based chemotherapy for the first-line treatment of advanced or metastatic ESCC. A BLA for toripalimab for advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review by the FDA with a target action date of April 2022.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma ("NPC") after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs, one for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC, and the other for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma, were accepted by the NMPA for review in February and July 2021, respectively.

In the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

On November 15, 2021 Thermo Fisher Scientific Inc., the world leader in serving science, reported innovative proteomics solutions and a series of co-marketing agreements with industry experts, advancing the throughput, comprehensiveness and quality of proteomics workflows for applications such as single-cell studies and translational research (Press release, Lifescience Newswire, NOV 15, 2021, https://news.lifesciencenewswire.com/newsroom/thermo-fisher-scientific-advances-proteomics-through-select-collaborations-and-new-analytical-instrument-solutions [SID1234595585]).

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The company will showcase these relationships, as well as new additions to its industry-leading offering of mass spectrometry (MS) and chromatography instruments, during the Human Proteome Organization (HUPO) Reconnect event, being held virtually November 15-19.

"Proteomics research has the potential to expand our scientific understanding and uncover new biomarkers to meet unmet medical needs," said Andreas Huhmer, senior director, life sciences research omics marketing, Thermo Fisher Scientific. "While there has been significant progress in our ability to perform advanced analyses such as single-cell and translational proteomics, there are still improvements needed in the efficiency and reproducibility of workflows. The agreements we’re announcing today, will enable us to continue to deliver innovative proteomics solutions to customers with a goal to make these workflows accessible to everyone."

New co-marketing agreements accelerate proteomics workflows

Enhanced quantitation capabilities for high-throughput proteomics

Thermo Fisher is extending their co-marketing agreement with Biognosys, a leading developer of next-generation proteomics solutions, to provide laboratories performing high-throughput plasma analysis with innovative and streamlined instruments, kits and software to enable efficient and accurate workflows at scale. The PQ500 Reference Peptide Kit from Biognosys is able to quantify more than 500 proteins in human plasma/serum samples as part of the SureQuant IS-PRM workflow, enabled only with the Thermo Scientific Orbitrap Exploris 480 mass spectrometer, delivering sensitive and accurate quantitation to drive scientific progress or clinical decision making. Biognosys’ SpectroDive software extends research applications to targeted proteomics enabling automated MS method set-up, signal processing and analysis of targeted experiments, such as the SureQuant IS-PRM workflow.

New liquid chromatography (LC) solution and acquisition strengthen separations for proteomics

The Thermo Scientific Vanquish Neo Ultra-High Performance Liquid Chromatography (UHPLC) System complements high-resolution Thermo Scientific Orbitrap mass spectrometry for proteomics analyses, minimizing sample loss and delivering the highest quality of data. The new system is designed for high-sensitivity LC-MS applications, with excellent analytical performance at flow rates from 1 nL/min to 100 µL/min up to 1500 bar. The separation capabilities and reproducibility of this all-in-one nano-, capillary- and micro-flow LC system will help users to overcome limitations of existing low-flow LC instruments.

Thermo Fisher has also extended its chromatography portfolio through the acquisition of Belgium-based PharmaFluidics, the developer of the μPAC range of micro-chip-based chromatography columns. The µPAC portfolio of columns enhance LC performance in biomarker, proteomics and drug research and development applications, helping biotechnology and pharmaceutical companies uncover new insights and advance scientific discovery.

Expanding single-cell proteomics workflow with sample preparation

One of Thermo Fisher’s goals is to provide customers with a platform to effectively and efficiently analyze thousands of single cells. A co-marketing agreement between Thermo Fisher and Cellenion, experts in single-cell sample preparation solutions, will deliver a full workflow, from sample to results, for scientists performing single-cell proteomics analysis. Laborious sample preparation has typically held back single-cell MS methods. To overcome this, Cellenion’s sample preparation solution, cellenONE, combines single-cell isolation and nanoliter dispensing to perform every step of the sample preparation using a single device. With single-cell proteomics providing vital information on the state of individual cells within heterogeneous environments, the combination of this sample preparation technology with Thermo Fisher’s TMT multiplexing technologies and Orbitrap mass spectrometers will open new doors for researchers.

On November 15, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug-development company focused on DNA-based immunotherapy and next-generation vaccines, reported financial results for the three and nine months ended September 30, 2021, and provided an update on clinical development programs with GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development for the treatment of advanced-stage ovarian cancer (Stage III/IV), and ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin under investigator-sponsored development for several cancer indications (Press release, Celsion, NOV 15, 2021, View Source [SID1234595584]). In addition, Celsion has two feasibility-stage platform technologies for the development of novel nucleic acid-based immunotherapies and next-generation vaccines for infectious diseases.

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"GEN-1 continues to show momentum as patient enrollment nears 70% with full enrollment targeted by the first half of 2022. We are encouraged with surgical resection results at the 100 mg/m² dose cohort in the Phase II OVATION 2 Study. From the first 36 patients with interval debulking surgery, 80% treated with GEN-1 at a dose of 100 mg/m² plus neoadjuvant chemotherapy (NACT) had a complete tumor resection (R0), which indicates a microscopically margin-negative resection with no gross or microscopic tumor remaining in the tumor bed; this compares with 56% of patients in the control arm having R0 resections. These results are reasonably consistent with those reported from our earlier Phase I trials in advanced-stage ovarian cancer," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.

"At the International Vaccines Congress in October, Celsion announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with our next-generation PLACCINE DNA vaccine," added Mr. Tardugno. "Our goal over the next several quarters is to demonstrate the superiority of Celsion’s multicistronic DNA vaccine over current mRNA vaccines with respect to the quality of immune response (higher affinity of neutralizing antibodies, IgG titers and T-cell response) against multiple SARS-CoV-2 variants, longer duration of immune response and a stable product at lower temperatures."

Recent Developments

GEN-1 Immunotherapy

Interim Data Reported on the OVATION 2 Study. Interim clinical data from the first 36 patients who have undergone interval debulking surgery are as follows:

●20 patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16 out of 20 patients (80%) having R0 resections.
●16 patients were treated with NACT only, with 9 out of 16 patients (56%) having R0 resections.
●When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to NACT.

●The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 16 patients treated with NACT only were comparable, as expected, to the 20 patients treated with GEN-1 at a dose of 100 mg/m² plus NACT, with both groups demonstrating an approximate 80% ORR.
Publication of OVATION 1 Study in the Journal of Clinical Cancer Research. In July 2021, the Company announced the publication of data from its Phase 1b OVATION 1 Study with GEN-1 in combination with NACT in patients with advanced ovarian cancer in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The study, authored by Premel H. Thaker, M.D. et al. and titled "GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-Escalation Study," is available here. Dr. Thaker, Professor of Gynecologic Oncology and Director of Gynecologic Oncology Clinical Research at the Washington University School of Medicine in St. Louis, is the study chair for the OVATION program.

The OVATION 1 Study enrolled 18 patients with newly diagnosed stage IIIC and IV epithelial ovarian cancer in a standard 3+3 dose-escalation design testing four GEN-1 doses (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) in combination with NACT (carboplatin-paclitaxel). There were 15 patients evaluable for safety, and 14 underwent interval debulking and were evaluable for RECIST.

As previously reported, there were no dose-limiting toxicities. As shown in the chart below, in the two highest doses of GEN-1 the objective response rate was 100% and the R0 resection rate was 88%. Newly published data show the CRS, which was analyzed in this paper for the first time, was 50% in the two highest doses of GEN-1, compared with 28% from a major publication evaluating CRS scoring.

Clinical Responses: Tumor Response, Surgical Outcome, Pathological Response and Chemotherapy Response Score with NAC/GEN-1 Escalating Doses

Translational Responses: IL-12 and IFN-γ Levels, Response to Immune-Suppressive Agents; Ratio of CD8+ Cells to Immune Suppressive Agents

●A dose-dependent increase in immunostimulatory cytokines IL-12 and its downstream cytokine IFN-γ in ascitic fluid. The anticancer effects of these cytokines are widely recognized in human malignancies.
●The proportion of myeloid dendritic cells in the peritoneal fluid trended higher (3.1-fold) accompanied by a similar 3.0-fold rise in CD8+ cells.
●GEN-1 appeared to reduce four immunosuppressive signals (Foxp3, IDO1, PD-1 and PD-L1) within the tumor microenvironment, a trend not seen with NAC therapy alone.
●GEN-1 appeared to stimulate the body’s immune system through the production of CD4 and CD8 cells.
●GEN-1 gene therapy was associated with an apparent increase in the cytotoxic state of T cells within the tumor microenvironment as indicated by the increases in the ratios of CD8+/CD4+ and CD8+/Treg cells. Indeed, higher CD8+/CD4+ T cell and CD8+/Treg ratios are considered prognostic for prolonged survival.

Vaccine Initiative

Vaccine Advisory Board Expanded. In July 2021, the Company announced the addition of Dan H. Barouch, M.D., Ph.D. and Luke D. Handke, Ph.D. to its Vaccine Advisory Board (VAB). They joined Britt A. Glaunsinger, Ph.D. and Xinzhen Yang, M.D., Ph.D. on the VAB, which was formed in February 2021.

Dr. Barouch is the principal investigator at the Barouch Laboratory, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and William Bosworth Castle Professor of Medicine at Harvard Medical School. In addition, he is a key participant in the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery, the National Institutes of Health Martin Delaney HIV-1 Cure Collaboratory and the Ragon Institute of MGH, MIT and Harvard. Dr. Barouch and his team were instrumental in developing the vector, a variant of an adenovirus called Ad26, that was used to make single-dose vaccines for HIV, tuberculosis and Zika, and ultimately, in conjunction with Johnson & Johnson researchers, SARS-CoV-2. He has authored numerous peer-reviewed articles.

Dr. Handke is a highly skilled molecular biologist and microbiologist with a decade of pharmaceutical industry experience including nine years with Pfizer’s Vaccine Research and Early Development Unit. At Pfizer he served as molecular biology lead on an early phase viral vaccine program and was the lead reviewer of data sources and literature citations for licensure application for the Trumenba meningococcal group B vaccine in the U.S. and in Europe. He began his career in vaccine research at Wyeth. He is co-author and co-inventor on various patent applications for a protein-based RSV vaccine and a SARS-CoV-2 detection assay and authored 10 peer-reviewed publications including six as first author. Dr. Handke is currently a Senior Scientist at the University of Nebraska Medical Center in Omaha. In addition to serving on the VAB, Dr. Handke will provide consulting services to Celsion in connection with its vaccine-development program, which involves DNA-based vectors in combination with proprietary non-viral cellular delivery agents. He also will advise Celsion as it advances this program into human clinical studies.

Results from In Vivo Studies with PLACCINE DNA Vaccine Platform Indicate Immune Response Against SARS-Cov-2. In September 2021, the Company announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with the Company’s next-generation PLACCINE DNA vaccine platform. Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the infection of cultured cells in a viral neutralization assay. The production of antibodies predicts the ability of PLACCINE to protect against SARS-CoV-2 exposure, and the elicitation of cytotoxic T-cell response shows the vaccine’s potential to eradicate cells infected with SARS-CoV-2. These findings demonstrate the potential immunogenicity of Celsion’s PLACCINE DNA vaccine, which is hypothesized to provide broad-spectrum protection and resistance against variants by incorporating multiple viral antigens, to improve vaccine stability at storage temperatures of 4oC and above, and to facilitate cheaper and easier manufacturing. Celsion reported these data at the International Vaccines Conference in October 2021.

Agreement with Hainan Poly Pharm to Manufacture Celsion’s DNA-based Vaccine. In September 2021, the Company announced an amendment to its existing contract manufacturing agreement with Hainan Poly Pharm Co. Ltd., a generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, to include development work for the Company’s investigational DNA-based COVID-19 vaccine. Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s vaccine based on its TheraPlas technology. Poly Pharm is experienced with chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization and manufacturing services to help customers advance new drug development projects. Its sites and pharmaceutical compounds have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA) and the World Health Organization (WHO).

Oral Presentation on Celsion’s Ongoing Work with DNA-based Vaccines at International Vaccines Congress. In October 2021, the Company announced that Khursheed Anwer, Ph.D., executive vice president and chief science officer, presented at the International Vaccines Congress . Dr. Anwer’s presentation was titled "Immunogenicity of DNA Vaccines based on Multicistronic Vectors and Synthetic DNA Delivery Systems" and can be viewed here. Dr. Anwer discussed ongoing proof-of-concept studies in SARS-CoV-2 with the Company’s DNA-based vaccine approach utilizing its PLACCINE platform. PLACCINE, Celsion’s proprietary design for DNA vectors, encompasses molecular elements designed to improve the immune response by targeting multiple antigens of a pathogen or multiple mutants of the same antigen. Dr. Anwer also reviewed the PLACCINE technology and the production of a family of DNA vaccine vectors expressing one or more SARS-CoV-2 surface antigens as a proof-of-concept target, verified vector composition and demonstrated expression of the encoded genes.

Corporate Developments

Presentations at Three Healthcare Investment Conferences. Celsion management made presentations at the following investment conferences in October:

●Chardan’s 5th Annual Genetic Medicines Conference. Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, and Khursheed Anwer, Ph.D., Celsion’s chief scientific officer, participated in a fireside chat.
●LD Micro Main Event. Jeffrey W. Church, Celsion’s chief financial officer, presented virtually.
●Alliance Global Partners’ Virtual Healthcare Conference. Mr. Tardugno participated in an oncology focused panel discussion moderated by James Molloy, Research Analyst.

Third Quarter Financial Results

For the quarter ended September 30, 2021, Celsion reported a net loss of $5.4 million ($0.06 per share), compared with a net loss of $8.1 million ($0.24 per share) in the same period of 2020. Operating expenses were $5.2 million in the third quarter of 2021, which represented a $0.9 million (21%) increase from $4.3 million in the same period of 2020.

The Company ended the third quarter of 2021 with $60.6 million in cash, investment securities, restricted cash and accrued interest receivable. Coupled with future sales of unused New Jersey NOL’s, the Company believes it has sufficient capital resources to fund its operations through the end of 2024.

Research and development (R&D) expenses were $2.5 million in the third quarter of 2021, consistent with $2.5 million reported in the third quarter of 2020. Costs associated with the OVATION 2 Study were $0.2 million in each of the third quarters of 2021 and 2020. R&D costs associated with both the development of GEN-1 to support the OVATION 2 Study and the development of the PLACCINE DNA technology platform increased to $1.1 million in the third quarter of 2021, compared with $0.7 million in the same period of 2020. Clinical development costs for the Phase III OPTIMA Study decreased $0.3 million to $0.2 million in the third quarter of 2021, compared with $0.5 million in the third quarter of 2020, due to the discontinuation of this 556-patient trial in the first quarter of 2021. Other costs related to clinical supplies and regulatory support for the Company’s clinical development programs decreased to $1.0 million in the third quarter of 2021 from $1.1 million in the third quarter of 2020, largely driven by higher manufacturing costs for GEN-1 clinical supplies for the Phase II portion of the OVATION 2 Study, offset by lower regulatory and manufacturing costs related to the OPTIMA Study.

General and administrative expenses were $2.7 million in the third quarter of 2021, compared with $1.8 million in the same period of 2020. The $0.9 million increase was primarily attributable to higher non-cash stock-compensation expense ($0.2 million), an increase in legal and professional fees ($0.6 million) and an increase in Directors’ and Officers’ insurance premiums ($0.1 million).

Non-operating expenses of $0.3 million in the third quarter of 2021 decreased from $3.9 million in the third quarter of 2020 due to (i) a non-cash charge of $1.1 million for the change in valuation of the earn-out milestone liability for the GEN-1 ovarian product candidate recognized in the third quarter of 2020 compared with a $0.3 million non-cash charge recognized in the current quarter; (ii) a non-cash charge of $2.4 million related to the impairment of certain in-process research and development assets related to the development of the Company’s glioblastoma multiforme (GBM) cancer product candidate in the third quarter of 2020; and (ii) lower interest expense of $0.4 million on the Company’s debt facilities in the current quarter, compared with the comparable prior year period. In June 2021, the Company entered into a new $10.0 million loan facility with SVB, with a portion of the proceeds used to retire all outstanding indebtedness under the Company’s venture debt facility entered in late June 2018 with Horizon Technology Finance Corporation.

Nine Month Financial Results

For the nine months ended September 30, 2021, the Company reported a net loss of $16.5 million ($0.21 per share), compared with a net loss of $18.5 million ($0.62 per share) in the same period of 2020. Operating expenses were $15.9 million during the first nine months of 2021, which represented a $1.8 million (13%) increase from $14.1 million in the same period of 2020.

Net cash used for operating activities was $11.1 million in the first nine months of 2021, compared with $11.9 million in the same period in 2020. This was in line with the Company’s projected cash utilization for 2021 of approximately $17 million, or an average of approximately $4.25 million per quarter. Cash provided by financing activities of $54.8 million during the first nine months of 2021 was derived from equity offerings in January 2021 and April 2021, the $10 million loan facility with SVB in June 2021 and the sale of the Company’s unused New Jersey NOLs in May 2021.

Research and development expenses decreased $0.9 million to $7.6 million in the first nine months of 2021 from $8.5 million in the comparable prior-year period. Costs associated with the OVATION 2 Study increased to $1.0 million in the first nine months of 2021 compared to $0.7 million in the same period of 2020. The Company initiated enrollment in the Phase 2 portion of the study during the third quarter of 2020. 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 $3.1 million in the first nine months of 2021, compared with $2.3 million in the comparable 2020 period. Costs for the Phase III OPTIMA Study decreased $1.2 million to $0.6 million in the first nine months of 2021, compared with $1.8 million in the first nine months of 2020, due to the discontinuation of this trial in the first quarter of 2021. Other costs related to clinical supplies and regulatory support for the Company’s clinical development programs decreased $0.8 million to $2.9 million in the first nine months of 2021, compared with the same prior-year period due to lower regulatory and manufacturing costs for the discontinued Phase III OPTIMA Study.

General and administrative expenses were $8.3 million in the first nine months of 2021, compared with $5.5 million in the same period of 2020. The $2.8 million increase was primarily attributable to higher non-cash stock-compensation expense ($1.0 million), an increase in legal and professional fees ($1.4 million) and an increase in Directors’ and Officers’ insurance premiums ($0.2 million).

Other expenses during the first nine months of 2021 included a non-cash charge of $0.3 million for the change in valuation of the earn-out milestone liability for the GEN-1 ovarian product candidate, compared with a non-cash charge of $1.4 million during the comparable prior-year period and a non-cash charge of $2.4 million related to the impairment of certain in-process research and development assets related to the development of the Company’s GBM cancer product candidate in the third quarter of 2020. In connection with the Company’s venture debt facilities, the Company incurred interest expense of $0.5 million during the first nine months of 2021, compared with $1.1 million during the same period in 2020. In June 2021, the Company entered into a new $10.0 million loan facility with SVB, with a portion of the proceeds used to retire all outstanding indebtedness under the Company’s venture debt facility with Horizon Technology Finance Corporation.

Conference Call

The Company will host a conference call to provide a business update, discuss its third quarter 2021 financial results and answer questions at 11:00 a.m. ET today. To participate in the call, please dial 1-800-353-6461(Toll-Free/North America) or +1-334-323-0501 (International/Toll) and ask for the Celsion Corporation Third Quarter 2021 Earnings Call (Conference Code: 4154518). The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay through December 1, 2021. The replay can be accessed at +1-719-457-0820 or 888-203-1112 using Conference ID: 4154518. An audio replay will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. ET on November 15, 2021.

On November 15, 2021 Portage Biotech Inc., (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that data being presented by Intensity Therapeutics during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting and the Connective Tissue Oncology Society (CTOS) Annual Meeting (Press release, Portage Biotech, NOV 15, 2021, View Source [SID1234595583]). Data from the Phase 2 IT-01 trial shows that Intensity’s lead asset, INT230-6 (PORT-1) is well tolerated with direct tumor-killing effects, both as a monotherapy and in combination with the approved checkpoint inhibitors pembrolizumab and ipilimumab. Highlights from the presentations are included below.

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"The promising results showcased in these presentations validate the broad treatment potential of INT230-6 (PORT-1) in multiple treatment regimens – alone, in combination with a PD-1 antibody and in combination with a CTLA-4 antibody – and show substantially longer survival when compared to historical data," said Dr. Ian Walters, Chief Executive Officer of Portage Biotech and Chief Medical Officer of Intensity. "The company has amassed data in over 110 patients and the continual favorable safety and efficacy profile bodes well for this therapy’s potential as a treatment for metastatic cancers that have been historically challenging to treat, including soft tissue sarcoma. We look forward to working with our collaborators at Intensity to initiate a randomized Phase 3 study in 2022 and to further exploring how INT230-6 (PORT-1) can impact survival and improve quality of life for these patients."

INT230-6 (PORT-1) is a novel intratumoral amphiphilic formulation developed by Intensity Therapeutics, a company affiliated with Portage. It delivers potent cancer-killing agents directly into the tumor to immediately reduce cancer burden, break down the cytokine wall and recruit immune cells to attack residual disease. The Phase 2 IT-01 trial is governed by joint development committees with Bristol Myers Squibb and Merck, in which Dr. Walters contributes as a representative of Intensity Therapeutics.

SITC 2021

Presentation Details:

Poster #501: Survival and Immune Response Data from Intratumoral INT230-6 Alone (IT-01) and with Pembrolizumab [KEYNOTE-A10] in Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors
Poster #536: Intratumoral INT230-6 shows a favorable safety profile and early signs of efficacy in advanced soft tissue sarcoma with monotherapy and in combination with Ipilimumab [Intensity IT-01; BMS#CA184-592]
Data Highlights:

INT230-6 demonstrates direct tumor killing in injected lesions
Immunohistochemistry analysis and abscopal results in non-injected lesions indicate dosing INT230-6 may also activate a T-cell mediated immune response
INT230-6 injection into tumors appears to be a promising approach in treating metastatic disease alone and in combination with immunotherapies
Biopsies from tumors treated using INT230-6 showed substantial tumor necrosis, reduction of viable cancer, a decreased cancer proliferation as measured by Ki67, and increased tumor infiltrating lymphocytes such as CD4 and CD8 T-cells
Exploratory analysis suggests promising survival for subjects receiving INT230-6 compared to historical standards
CTOS 2021

Presentation Details:

Paper #33: Safety and efficacy from a phase 1/2 study of intratumoral INT230-6 alone or in combination with ipilimumab [Intensity# it-01; BMS# ca184-592] in adult subjects with metastatic sarcomas (NCT 03058289)
Data Highlights:

Preliminary data suggests that INT230-6 (PORT-1), as a monotherapy, demonstrates direct tumor killing in soft tissue sarcoma subjects that can elicit an anti-cancer immune response
INT230-6 (PORT-1) was also shown to be well tolerated either as a monotherapy or in combination with checkpoint inhibitor ipilimumab
Exploratory analysis suggests promising survival with dosing, based on total tumor burden, as compared to historic survival from historical sarcoma studies
To view the full announcement from Intensity Therapeutics, visit their website at www.intensitytherapeutics.com.

About PORT-1
INT230-6 (PORT-1) contains amphiphilic molecules combined with anti-cancer payloads, offering a next-generation formulation to safely deliver up to three times the systemic dose of cancer-killing agents directly into tumors. PORT-1 breaks down the cytokine wall and stimulates immune cells to process tumor antigens and attack residual disease. Used alone or in combination with checkpoint inhibitors, PORT-1 may lead to improved survival with dramatically fewer unwanted side effects. PORT-1 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for triple-negative breast cancer, demonstrating the importance of ongoing drug development and improved therapies for this aggressive type of cancer. Select members of the Portage management team contribute to the development efforts led by Intensity Therapeutics.

About Intensity Therapeutics
Intensity Therapeutics, Inc. is a privately held, clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRx℠ technology platform to create new, proprietary drug formulations that following direct injection rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity’s product candidates have the potential to induce an adaptive immune response that not only attacks the injected tumor but also non-injected tumors. The Company executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s (NCI) Vaccine Branch in 2014 and has partnerships with Merck and Bristol Myers Squibb. For more information, please visit www.intensitytherapeutics.com and follow us on Twitter @IntensityInc.