On March 17, 2021 Helix BioPharma Corp. (TSX: "HBP"), a an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the fiscal second quarter ended January 31, 2021 (Press release, Helix BioPharma, MAR 17, 2021, View Source [SID1234576793]).

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OVERVIEW The Company reported a net loss and total comprehensive loss of $2,492,000 and $2,714,000 for the three and sixmonth periods ended January 31, 2021. For the three and six-month periods ended January 31, 2020, net loss and total comprehensive loss totalled $2,255,000 and $4,466,000, respectively. The net loss and total comprehensive loss for the three-month period ending January 31, 2021 included a net loss of $626,000 (2020-$nil) and for the sixmonth period ending January 31, 2021 a net gain of $1,536,000 (2020-$nil) as a result of the loss of control of a subsidiary and ultimately, a final tranche disposition on December 22, 2020 for gross proceeds of $2,308,000. Subsequent to the quarter ending January 31, 2021, BDO Canada LLP resigned as the Company’s auditors.

The Company has engaged Marcum LLP as its new auditors. Research and development Research and development expense for the three and six-month periods ended January 31, 2021 totalled $1,086,000 and $2,170,000, respectively, as compared to $1,588,000 and $3,099,000 respectively for the three and six-month periods ended January 31, 2020, respectively.

The reduction in research and development expenditures for both the three and six-month periods ended January 31, 2021 when compared to the prior year, is mainly the result of lower clinical study and intellectual property expenditures. 1 Lower clinical operation expenses are due to spending having occurred in the prior year related to the Company’s LDOS003 Phase II clinical study in Poland and the Ukraine which has since concluded but currently awaiting reporting. The Company’s new LDOS006 Phase Ib/II pancreatic clinical study in the U.S. was still in the early stages with U.S. FDA approval only having been received in August 2019 and enrollment having commenced in December 2019. COVID19 slowed down patient enrollment.

The Company has added a new study site on March 12, 2021 and expects to add a third site in a months’ time in order to increase the patient enrollment rate. Lower intellectual property maintenance costs are mainly the result of the Company reclaiming certain costs incurred on behalf of its former subsidiary as per agreement. Operating, general and administration Operating, general and administration expenses for the three and six-month periods ended January 31, 2021 totalled $818,000 and $2,121,000, respectively, as compared to $654,000 and $1,363,000 for the three and six-month periods ended January 31, 2020, respectively The increase in operating, general and administration expenditures for both the three and six-month periods ended January 31, 2021 when compared to the prior year, is mainly the result of higher stock-based compensation expense associated with the vesting of stock options that were granted to directors of the Company over their vesting period in addition to higher legal costs and auditor fees. The Company has been in discussions with various groups both in the U.S. and Canada and has been incurring additional legal and audit expenses as part of the Company’s objective to raise additional capital to qualify for a listing on a U.S. stock exchange such as NASDAQ.

LIQUIDITY AND CAPITAL RESOURCES The Company reported a net loss and total comprehensive loss of $2,492,000 for the three-month period ended January 31, 2021 (2020-$2,255,000) and $2,714,000 for the six-month period ended January 31, 2021 (2020-$4,466,000). As at January 31, 2021 the Company had working capital of $3,639,000, shareholders’ equity of $3,766,000 and a deficit of $183,230,000. As at July 31, 2020 the Company had working capital of $2,735,000, shareholders’ equity of $2,981,000, a deficit of $180,516,000.

The Company experienced a working capital deficiency throughout fiscal 2018 and 2019 until August 21, 2019 when the Company closed the first of a series of private placements with a more recent financing occurring in December 2020. During the quarter ended January 31, 2021, the Company completed two rounds of private placements for gross proceeds totalling $4,100,000. On December 22, 2020 the Company disposed its remaining interest in a subsidiary for gross proceeds of $2,308,000. The Company’s cash reserves of $4,098,000 as at January 31, 2021 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see planned research and development initiatives through to completion.

Though the funds raised have assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with working capital requirements. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, to be critical for its development needs.

The Company’s Interim Condensed Financial Statements (unaudited) 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 March 17, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the fourth quarter and full year ended December 31, 2020 (Press release, CTI BioPharma, MAR 17, 2021, View Source [SID1234576792]).

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"This past quarter, CTI has executed on the critical clinical, regulatory and commercial activities that will allow for the potential U.S. approval and commercial launch of pacritinib in 2021," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We continue to work diligently on our rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for pacritinib, for use in myelofibrosis patients with severe thrombocytopenia, and are on track to complete the submission before the end of this month. Pending priority review and approval by the FDA, we are planning to launch pacritinib in the United States by the end of the year. Over the last quarter, we have focused on the key pre-commercial activities that will enable a successful launch, including the recruitment of key leadership roles in marketing and sales, and the initiation of our disease awareness, market access, and field force strategies. We look forward to being able to provide pacritinib to myelofibrosis patients who are underserved by existing therapies."

Expected Milestones

Expected completion of rolling NDA submission for pacritinib in myelofibrosis patients with severe thrombocytopenia – Q1 2021
Expected FDA approval and U.S. commercial launch of pacritinib in myelofibrosis patients with severe thrombocytopenia – by end of 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – mid-2021
Fourth Quarter Financial Results

Operating loss was $14.8 million and $47.8 million for the three months and year ended December 31, 2020, respectively, as compared to an operating loss of $9.5 million and $40.7 million for the respective periods in 2019. The increase in operating loss for the three months ended December 31, 2020, as compared to the comparable period in 2019, resulted primarily from more extensive research and development activities. The increase in operating loss for the year ended December 31, 2020, as compared to the comparable period in 2019, resulted primarily from the recording of a full allowance against certain VAT receivables due to a reduced certainty of their collectability.

No revenues were recognized for the three months and year ended December 31, 2020 or for the three months ended December 31, 2019, as compared to revenues of $3.3 million recognized for the year ended December 31, 2019. License and contract revenues in 2019 resulted from royalty and other payments received from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and were related to the asset purchase agreement and transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.

Net loss for the three months ended December 31, 2020 was $15.0 million, or $0.20 for basic and diluted loss per share, as compared to a net loss of $8.2 million, or $0.14 for basic and diluted loss per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $52.5 million, or $0.74 for basic and diluted loss per share, as compared to a net loss of $40.0 million, or $0.69 for basic and diluted loss per share, for the same period in 2019.

As of December 31, 2020, cash, cash equivalents and short-term investments totaled $52.5 million, as compared to $33.7 million as of December 31, 2019. We expect our current cash, cash equivalents and short-term investments will enable us to fund our operations into the second quarter of 2021.

Conference Call and Webcast

CTI will host a conference call and webcast to review its fourth quarter 2020 financial results and provide an update on business activities today, March 17 at 4:30 PM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 9095063. A live audio webcast of the event may also be accessed through the "Investors" section of CTI’s website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.

About Myelofibrosis and Severe Thrombocytopenia

Myelofibrosis is a type of bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50,000 per microliter, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to correlate with treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, creating a significant area of unmet medical need.

On March 17, 2021 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines,reported fourth quarter and full year 2020 financial results and operational progress (Press release, Codiak Biosciences, MAR 17, 2021, View Source [SID1234576791]).

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"The past year was tremendously productive for Codiak as we brought our first two programs into the clinic, the first ever engineered exosome therapeutic candidates to be tested in humans, and completed a successful initial public offering," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "The early data from our exoIL-12 program have provided validation of our approach and propel us into what we anticipate will be an exciting year ahead, with multiple data read-outs and the initiation of a third clinical program expected."

Fourth Quarter 2020 and Recent Highlights

Reported initial pharmacokinetic/pharmacodynamic and tolerability data from randomized, placebo-controlled healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and selected pharmacological dose and regimen to carry forward into assessment in patients with cutaneous T cell lymphoma (CTCL)
Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors
Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies
Closed IPO in October 2020, raising $74.4 million in net proceeds
Published manuscript detailing the exoIL-12 preclinical program in Molecular Cancer Therapeutics
Published manuscript highlighting versatility of the engEx Platform in the online edition of Molecular Therapy
Closed follow-on public offering in February 2021, raising $62.0 million in net proceeds
Anticipated Milestones and Events

Late-breaking abstract poster presentation of the full pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held April 10-15, 2021
Poster presentation of preclinical data from the exoASO-STAT6 program at the AACR (Free AACR Whitepaper) Annual Meeting, to be held April 10-15, 2021
Safety and preliminary pharmacodynamics and efficacy data from exoSTING Phase 1/2 clinical trial in patients with solid tumors expected mid-2021
Investigational New Drug (IND) application filing for exoASO-STAT6 program to enable initiation of clinical trials anticipated during the second half of 2021
Biomarker, safety and preliminary pharmacodynamics and efficacy data in CTCL patients from exoIL-12 Phase 1 trial expected by year-end 2021
Fourth Quarter and Full Year 2020 Financial Results
Total revenues for the quarter ended December 31, 2020 were $1.6 million, compared to $0.2 million for the same period in 2019. Total revenues for the year ended December 31, 2020 were $2.9 million, compared to $0.4 million for the same period in 2019. These increases were primarily due to revenue recognized in connection with our collaboration with Sarepta Therapeutics.

Net loss for the quarter ended December 31, 2020 was $18.0 million, compared to a net loss of $21.6 million for the same period in 2019. Net loss for the year ended December 31, 2020 was $91.7 million, compared to a net loss of $78.0 million for the same period in 2019. Net loss for the quarter and year was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform.

Research and development expenses were $13.3 million for the quarter ended December 31, 2020 compared to $17.7 million for the same period in 2019. The decrease in research and development expenses was driven primarily by the timing of external manufacturing expenditures in the prior year.

Research and development expenses were $74.0 million for the year ended December 31, 2020 compared to $59.5 million for the same period in 2019. The year-over-year increase was primarily driven by an increase in license milestones, personnel costs, and clinical development expenses related to the initiation of the exoIL-12 and exoSTING clinical trials in September 2020.

General and administrative expenses were $5.9 million for the quarter ended December 31, 2020 compared to $4.3 million for the same period in 2019. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

General and administrative expenses were $19.9 million for the year ended December 31, 2020 compared to $21.0 million for the same period in 2019. The year-over-year decrease was primarily driven by a decrease in consulting, accounting and legal fees.

As of December 31, 2020, Codiak had cash and cash equivalents of approximately $88.9 million. Subsequent to year end, Codiak closed a public offering in February 2021, raising $62.0 million in net proceeds. Based on our current operating plan, we expect our cash and cash equivalents as of December 31, 2020, together with the net proceeds from our follow-on public offering in February 2021, will enable us to fund our operating expenses and capital expenditure requirements through the end of 2022.

On March 17, 2021 CNS Pharmaceuticals, Inc. Presented the Corporate Presentation (Presentation, CNS Pharmaceuticals, MAR 17, 2021, View Source [SID1234576790]).

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On March 17, 2021 Cerecor Presented the Corporate Presentation (Presentation, Cerecor, MAR 17, 2021, View Source [SID1234576789]).

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