On June 11, 2019 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported its financial results for its fiscal third quarter ended April 30, 2019 (Press release, Helix BioPharma, JUN 11, 2019, View Source [SID1234537432]).

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FINANCIAL REVIEW

The Company recorded a net loss and total comprehensive loss of $2,071,000 ($0.02 loss per common share) and $2,147,000 ($0.02 loss per common share) for the three-month periods ended April 30, 2019 and 2018, respectively. For the nine-month periods ended April 30, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $5,358,000 ($0.05 loss per common share) and $7,015,000 ($0.07 loss per common share).

Research and development

Research and development costs for the three and nine-month periods ended April 30, 2019 totalled $1,351,000 and $3,695,000, respectively ($1,435,000 and $5,095,000 respectively for the three and nine-month periods ended April 30, 2018).

L-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $1,054,000 and $2,703,000, respectively ($1,029,000 and $4,039,000 respectively for the three and nine-month periods ended April 30, 2018). L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., and LDOS003 Phase II clinical study in Poland, Ukraine and Hungary.

The Company’s LDOS001 clinical study continues to face patient enrolment challenges. An accelerated dosing protocol has been approved to help accelerate the LDOS001 clinical study. The Company continues to be committed to the LDOS001 study and has re-allocated limited resources to improve patient enrollment. Enrolment in the Company’s LDOS002 clinical study was previously halted at the end of stage 1 of a two-stage phase II study as the intensified schedule did not result in improving patient benefits compared to that observed in the Phase I portion of the study. The Company’s LDOS003 clinical study recently dosed its third patient and commenced second cohort enrollment. The Company is very close to finalizing a clinical study protocol for a Phase I/II study with L-DOS47 to be given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer. The Company expects to file an investigational new drug application with the U.S. Food and Drug Administration for a study by the end of the month.

The Company’s Polish subsidiary continues to focus its activities on the V-DOS47 pre-clinical program. V-DOS47 research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $137,000 and $369,000, respectively ($133,000 and $310,000 respectively for the three and nine-month periods ended April 30, 2018). For the three and nine-month periods ended April 30, 2019 the Company’s Polish subsidiary received grant funding of $130,000 and $352,000, respectively ($144,000 and $344,000 respectively for the three and nine-month periods ended April 30, 2018). Grant funding for the V-DOS4 program is the result of an agreement entered into with the Polish National Centre for Research and Development ("PNCRD"). The Agreement may be terminated by either party upon one month’s written notice and must also state the grounds for which the Agreement is being terminated. In certain cases of termination, the Company’s Polish subsidiary may be obligated to return the received financial support in full within fourteen days of the day notice is served, with interest. As at April 30, 2019 that Company’s Polish subsidiary has received grant funds of approximately PLN3,634,609 or 28% of the entire grant funding amount approved by the PNCRD.

CAR-T research and development expenses for the three and nine-month periods ended April 30, 2019 totalled $nil and $333,000 respectively ($192,000 and $317,000 respectively for the three and nine-month periods ended April 30, 2018). The Company commenced development of novel CAR-T therapeutics and new antibody-based technologies for cell-based therapies. The Company’s CAR-T expenditures relate primarily to collaborative research activities with ProMab Biotechnologies Inc.

Trademark and patent related expenses for the three and nine-month periods ended April 30, 2019 totalled $109,000 and $177,000, respectively ($70,000 and $308,000 respectively for the three and nine-month periods ended April 30, 2019). The Company continues to ensure it adequately protects its intellectual property.

Operating, general and administration

Operating, general and administration expenses for the three and nine-month periods ended April 30, 2019 and 2018 totalled $699,000 and $1,605,000, respectively ($686,000 and $1,856,000 respectively for the three and nine-month periods ended April 30, 2018). The decrease in operating, general and administration expenses mainly reflects the normalization of expenditures after companywide cost cutting initiatives.

The following table outlines operating, general and administration costs expensed for the following periods:

LIQUIDITY AND CAPITAL RESOURCES

The Company recorded a net loss and total comprehensive loss of $2,071,000 ($0.02 loss per common share) and $2,147,000 ($0.02 loss per common share) for the three-month periods ended April 30, 2019 and 2018, respectively. For the nine-month periods ended April 30, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $5,358,000 ($0.05 loss per common share) and $7,015,000 ($0.07 loss per common share), respectively.

As at April 30, 2019 the Company had a working capital deficiency of $2,203,000, shareholders’ deficiency of $1,920,000 and a deficit of $169,363,000. As at July 31, 2018 the Company had a working capital deficiency of $1,901,000, shareholders’ deficiency of $1,527,000 and a deficit of $164,005,000.

The Company continues to work with vendors to manage its cash position while ensuring vendors continue providing services while being paid, albeit over a longer period of time than previously agreed terms. Some vendors have placed the Company on hold (cash in advance) and is impacting the Company’s clinical development program. The Company has raised gross proceeds of approximately $8,518,000 from private placement financings during fiscal 2018 and an additional $6,014,000 during the nine-month period ended April 30, 2019. Subsequent to the April 30, 2019 quarter end, the Company announced the closing of a private placement on May 29th, 2019 for gross proceeds of $507,960. Nevertheless, the Company’s cash reserves of $938,000 as at April 30, 2019 continue to be insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see the current or any planned research and development initiatives through to completion. Though the funds raised have somewhat assisted the Company in dealing with its working capital deficiency and attempts to make vendors current, additional funds are required to advance the various clinical and preclinical programs, pay for the Company’s overhead costs and its past due vendors. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs.

Additional information can be found about the Company’s liquidity and capital resources in the Company’s Management Discussion and Analysis.

The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and nine-month periods ending April 30, 2019 and 2018 and the condensed unaudited interim consolidated statement of cash flows for the nine-month periods ending April 30, 2019 and 2018 are summarized below:

The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.

On June 11, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that the design of the "TELLOMAK" Phase II trial and new preclinical data supporting the potential of IPH4102 in peripheral T-cell lymphoma ("PTCL") as well as Adult T-cell leukemia/lymphoma ("ATLL") will be presented at the International Conference on Malignant Lymphoma ("ICML"), held from 18 to 22 June 2019 in Lugano, Switzerland (Press release, Innate Pharma, JUN 11, 2019, View Source [SID1234537018]).

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An oral presentation will take place on Wednesday, June 19, by Pr. Pierluigi Porcu, Director of the Division of Medical Oncology and Hematopoietic Stem Cell Transplantation at Thomas Jefferson University, Philadelphia.

"We are committed to an efficient execution of the TELLOMAK trial, which could potentially support a future BLA submission for IPH4102 in Sézary syndrome", said Pierre Dodion, Chief Medical Officer of Innate Pharma. "The 2-stage design for the mycosis fungoides ("MF") and PTCL cohorts stratified by KIR3DL2 expression will allow us to identify patients that are most likely to benefit from treatment. We believe this will optimize the delivery of proof of concept data to inform the design of future potential pivotal trials. We expect to provide an update on the outcome of the first stage of the MF and PTCL cohorts in the second half of 2020 and report initial efficacy data for the different cohorts starting in 2021."

New preclinical data further support the rationale to evaluate the potential of IPH4102 in larger subsets of T-cell lymphoma. The findings demonstrate that KIR3DL2 is expressed in multiple subtypes of PTCL and that incubation of T-cell lymphoma cell lines with a combination chemotherapy regimen consisting of Gemcitabine and Oxaliplatin (GemOx) enhances KIR3DL2 expression. Moreover, the combination of IPH4102 and GemOx improves anti-tumor activity against a KIR3DL2-positive T-cell line in-vitro.

Another set of preclinical data supports the expansion of the IPH4102 development program in ATLL, which is mostly prevalent in Asia. The data demonstrates that KIR3DL2 expression is mainly associated with the ATLL acute subtype, a subtype that is the most frequent and associated with the poorest prognosis.

Presentation and Posters:
"TELLOMAK: T-cell lymphoma anti-KIR3DL2 therapy: An open label, multicohort, multi-center, international phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with advanced T-cell lymphoma",P. Porcu, Philadelphia, PA (USA); article Nr OT06; "Ongoing trials", Wednesday, June 19, 17:55, Aula Magna (USI Università)
"KIR3DL2 is expressed in peripheral T-cell lymphomas and may be a therapeutic target", M. Cheminant, Paris (France); poster Nr. 157, poster discussion June 20-21, 12:30-13:00, Marquee
"Membrane Expression of NK Receptor KIR3DL2 Contributes to Delineate the Acute-type and is a Therapeutic Target in ATL", M. Cheminant, Paris (France); poster Nr. 218, poster discussion June 20-21, 12:30-13:00, Marquee

About TELLOMAK:
TELLOMAK is a global, open-label, multicohort Phase II clinical trial conducted in the United States and Europe. In this trial, IPH4102 is evaluated alone and in combination with chemotherapy in patients with advanced TCL. TELLOMAK is expected to recruit up to 250 patients, with IPH4102 evaluated:

As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior treatments, including mogamulizumab,
As a single agent in approximately 90 patients with MF who have received at least two systemic therapies, and
In combination with standard chemotherapy (GemOx) in approximately 100 patients with PTCL who have received at least one prior treatment.
In patients with MF and PTCL, the study is designed to evaluate the benefit of IPH4102 according to KIR3DL2 expression: the study will comprise two cohorts for each of the 2 indications, testing IPH4102 in KIR3DL2 expressing and non-expressing patients. These cohorts will follow a Simon 2-stage design that will terminate if treatment is considered futile. The Sézary syndrome arm of the study could enable the registration of IPH4102 in this indication.

The primary endpoint of the trial is objective response rate. Key secondary measures include incidence of treatment emergent adverse events, quality of life, overall response rate, progression-free survival and overall survival.

On June 11, 2019 MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, reported that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme (Press release, MetVital, JUN 11, 2019, View Source [SID1234537004]). The notice to proceed was received following MetVital’s submission of an investigational new drug (IND) application for this program. FDA has approved a Phase 2A "Proof of Concept" trial to advance.

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AEO, a patented metabolite, is MetVital’s lead clinical development candidate for Glioblastoma Multiforme, a malicious type of brain cancer. Measured endpoints in the trial include Overall Survival (OS), Progression Free Survival at 6 months (PFS-6) and Seizure amelioration.

"The FDA’s acceptance of this commercial IND application is an important milestone for MetVital, as it allows us to immediately go into Phase 2A testing," said Alan Cash, president and chief executive officer of MetVital, Inc. "We are excited about the potential of modulating the excess glutamate levels in the central nervous system for patients with brain cancer, and the potential of the drug for a wide variety of other diseases." AEO is also being examined in Investigator lead clinical trials for the treatment of Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s disease.

Anhydrous Enol-Oxaloacetate is a metabolite that has demonstrated efficacy in animal models with human Glioblastoma Multiforme tissue implants, in animal models of ALS, and in animal models of Alzheimer’s disease. US FDA Orphan Drug Designations for oxaloacetate have been received for Gliomas, ALS and Hepatocellular Carcinoma.

Glioblastoma Multiforme is the most aggressive of the gliomas. It is often referred to as a grade IV astrocytoma, and is the most common type of brain cancer.

On June 11, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported that the Company will host a conference call and live webcast on Tuesday, June 25, 2019, at 1:30 p.m. Pacific Time/4:30 p.m. Eastern Time to provide a mid-year update on its clinical and preclinical programs (Press release, Arcus Biosciences, JUN 11, 2019, View Source [SID1234537003]).

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Investors interested in listening to the conference call may do so by dialing (866) 211-3164 in the U.S. or (647) 689-6573 internationally, using Conference ID: 7163128.

To access the live webcast and accompanying slide presentation, please visit the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company’s website for approximately 30 days.

On June 11, 2019 Celsius Therapeutics, a company translating single-cell genomic insights into precision therapeutics for patients with autoimmune diseases and cancer, reported the appointment of Tariq Kassum, M.D., as president and chief executive officer (Press release, Celsius Therapeutics, JUN 11, 2019, View Source [SID1234537002]). Dr. Kassum brings nearly 20 years of experience in the biopharmaceutical industry to Celsius. He succeeds interim CEO Alexis Borisy, who will remain chairman of the company’s board of directors.

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"Since its launch just over a year ago, Celsius has been making tremendous progress, and we are very excited to welcome Tariq as CEO to lead the company through its next phase of development," said Alexis Borisy, chairman of Celsius. "Tariq brings a highly diverse skill set incorporating corporate development, strategy and business leadership. His extensive experience in multiple settings in the biotechnology industry will be instrumental in helping guide the company going forward."

Dr. Kassum joins the company from Obsidian Therapeutics, where he was a co-founder and served as chief operating officer and head of corporate development. During this time, Dr. Kassum helped build Obsidian into a leading platform technology company and played a central role in the company’s strategic partnership with Celgene. Prior to Obsidian, Dr. Kassum spent seven years with Millennium Pharmaceuticals and Takeda, most recently as vice president, business development and strategy for Takeda Oncology, responsible for transactions, collaborations, alliance management and strategic planning. He also led Takeda’s global corporate development efforts, where he managed multiple acquisitions and divestitures. Prior to Takeda, Dr. Kassum was an analyst covering healthcare equities for institutional investment firms, where he led diligence and investment decisions on numerous companies and pharmaceutical compounds. He began his career as an investment banker with CIBC World Markets serving clients in the biotechnology and specialty pharmaceuticals industries. He holds an M.D. from University of Toronto and an A.B. from Cornell University.

"Celsius has integrated a unique combination of technologies, including single-cell genomics, machine learning, deep biology and drug discovery, all in the service of patients with serious conditions including autoimmune diseases and cancer," said Dr. Kassum. "I am thrilled to be joining the company at this stage as we establish the power of this multifaceted approach to drive a portfolio of transformative therapies for patients."