On March 11, 2021 Pacylex Pharmaceuticals, an oncology company unlocking a new approach to cancer therapy, reported the receipt of a No Objection Letter from Health Canada on March 8, 2021, opening the way for a planned Phase 1 Trial of PCLX-001 in relapsed/refractory B-cell Non-Hodgkin Lymphoma and advanced solid malignancies (Press release, Pacylex Pharmaceuticals, MAR 11, 2021, View Source [SID1234645064]). Pacylex is developing this NMT inhibitor, PCLX-001, as a first in class therapy for various cancers. PCLX-001 is believed to be the first NMT inhibitor that will be clinically tested.

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Three principal investigators will oversee the clinical study at three clinical sites in Canada: Dr. John Kuruvilla at Princess Margaret Cancer Centre in Toronto, Dr. Randeep Sangha at the Cross Cancer Institute in Edmonton and Dr. Laurie Sehn at the British Columbia Cancer Center in Vancouver.

"Health Canada approval to conduct this trial is an exciting step in bringing PCLX-001 into the clinic. As a first-in-class agent with a new mechanism of action, we plan to see how well people with lymphoma and other cancers tolerate the drug and hope to see some of them benefit," said Dr. Sangha, MD FRCPC, Director, Clinical Trials Unit, Cross Cancer Institute.

Dr. Kuruvilla added "We are excited to be working with other Canadian research teams and Pacylex to study a novel therapy with a unique mechanism of action in patients with lymphoma". Dr. Kuruvilla is Clinician Investigator in the Cancer Clinical Research Unit (CCRU), Princess Margaret Cancer Centre.

Clinical site preparations are underway for the open label, dose escalation, Phase 1 clinical trial, principally to evaluate the safety of PCLX-001. The study will enroll 20-30 patients and the Company anticipates that enrollment will begin in the second quarter of 2021.

Pacylex received a milestone-based Alberta Innovates AICE grant in 2020 to help fund this study, and the No Objection Letter triggered the first milestone payment from this grant. The Alberta Cancer Foundation and the Cure Cancer Foundation both provided support for this research.

PCLX-001

PCLX-001 is a small molecule, first-in-class N-myristoyltransferase (NMT) inhibitor, originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness funded by Wellcome Trust. Pacylex is developing PCLX-001, which has excellent oral bioavailabilty, to treat leukemia and lymphoma. PCLX-001 selectively kills cancer cells and completely regresses (eliminates) tumors in animal models of acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and Burkitt’s lymphoma (BL). PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the level of NMT2 is correlated with survival, suggesting an important biological role in these cancers. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as Ibrutinib (Imbruvica) and Dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.

On March 11, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported Jesse Ledger, Miravo’s President & Chief Executive Officer and Kelly Demerino, Miravo’s Interim Chief Financial Officer reported that it will be presenting at the Q1 Virtual Investor Summit (Press release, Nuvo Pharmaceuticals, MAR 11, 2021, View Source [SID1234580414]).

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DATE: Wednesday, March 24th, 2021

TIME: 3:30 p.m. EST

COMPLIMENTARY
REGISTRATION: View Source

About The Investor Summit

The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. The Q1 Investor Summit will take place virtually, featuring 100 companies and over 300 institutional and retail investors.
Please visit the website at www.investorsummitgroup.com

On March 11, 2021 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming virtual poster presentation at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 10-15 and May 17-21, 2021 (Press release, Bio-Path Holdings, MAR 11, 2021, View Source [SID1234577609]).

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Dr. Maria Gagliardi, a Research Scientist at Bio-Path Holdings, will discuss pre-clinical studies of BP1002 (liposomal Bcl-2 antisense) in combination with decitabine as a potential treatment against venetoclax-resistant cells.

Details for the virtual poster presentation are as follows:

Date: April 10, 2021

Presentation Time: 8:30 am Eastern Time

Session: Biological Therapeutic Agents

Abstract Number: 939

Title: The combination of liposomal Bcl-2 antisense oligonucleotide (BP1002) with decitabine is efficacious in venetoclax-resistant cells

On March 11, 2021 AVEO Oncology (Nasdaq: AVEO) reported that it has completed a drawdown of $20 million under its $45 million loan and security agreement with Hercules Capital, Inc. (NYSE: HTGC, "Hercules") and its affiliates (Press release, AVEO, MAR 11, 2021, View Source [SID1234577595]). This second tranche was made available in connection with the recent U.S. Food and Drug Administration (FDA) approval of FOTIVDA (tivozanib).

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"With the additional $20 million now available to us from Hercules, AVEO is well positioned to support what we believe will be a successful launch of FOTIVDA in the U.S.," said Michael Bailey, president and chief executive officer of AVEO. "Our core infrastructure and core commercial organization is in place, and we now look forward to delivering on the promise of FOTIVDA. We also expect to see meaningful progress within our pipeline programs in the coming quarters, including our immunotherapy combination programs for tivozanib, our Phase 2 study of ficlatuzumab and our recently initiated Phase 1 study of AV-380."

With the closing of the second tranche, AVEO has drawn down a total of $35 million under its loan and security agreement with Hercules. An additional $5 million tranche becomes available if net product revenues of FOTIVDA reach $35 million within a specified time frame, and the final $5 million tranche would be available after that time upon the lender’s consent.

As previously disclosed, AVEO believes that its $68.8 million in cash, cash equivalents and marketable securities as of September 30, 2020, along with proceeds from the $20 million loan facility drawdown, together with anticipated partnership cost sharing reimbursements, royalties from EUSA’s FOTIVDA sales and the resulting product revenues upon the commercial launch of FOTIVDA (tivozanib) in the U.S. and the potential additional $10 million in credit under the Hercules loan, would allow the Company to fund planned operations into 2022.

On March 11, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2020 (Press release, DBV Technologies, MAR 11, 2021, View Source [SID1234576735]). The financials have been audited by the Company’s statutory auditors and were approved by the Board of Directors on March 11, 2021. The audit report will be issued by the Company’s auditors in March 2021.

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"DBV ended 2020 well positioned to advance Viaskin Peanut towards potential approval in both the United States and European Union," said Daniel Tasse, Chief Executive Officer of DBV Technologies. "We remain focused on advancing our strategic objectives in 2021 and beyond as we continue to work towards improving the lives of patients with food allergies."

Recent Business Developments

Viaskin Peanut US: DBV has commenced a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the best one or two performing patches. All trial participants are expected to complete the trial by the end of March.
DBV plans to advance those patches selected for use in the protein transport study (EQUAL) and adhesion and safety study (STAMP) that will be discussed with the FDA.
Viaskin Peanut EU: DBV received the European Medicines Agency (EMA) Day 120 questions which are consistent with both DBV’s expectations and pre-filing conversations with the EMA. DBV did not receive questions about the impact of adhesion on efficacy.
Full-Year 2020 Financial Highlights1

Cash & Cash Equivalents: cash and cash equivalents as of December 31, 2020 were $196.4 million, compared to $193.3 million as of December 31, 2019. In 2020, cash used in operating activities was $(165.6) million under U.S. GAAP and $(160.9) million under IFRS and cash flows used in investment activities were $(2.9) million. Cash from financing activities were $149.5 million under U.S. GAAP and $144.8 million under IFRS, including $150.0 million received in connection with DBV’s follow-on public offering of its securities in the first quarter of 2020. Based on its current assumptions, DBV expects that its current cash and cash equivalents, will support its operations until the second half of 2022.

Operating Income: operating income was $11.3 million in 2020, compared to $14.7 million in 2019, a decrease of 23.3%. In both 2020 and 2019, operating income was primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science.

Operating Expenses: operating expenses for the year ended December 31, 2020, were $170.1 million under U.S. GAAP and $168.9 million under IFRS, compared to $185.7 million under U.S. GAAP and $185.1 million under IFRS for the year ended December 31, 2019. Excluding restructuring costs discussed below, operating expenses for the year ended December 31, 2020 were $146.6 million under U.S. GAAP and $145.9 million under IFRS. The overall decrease in operating expenses, excluding restructuring costs, was primarily due to the budget discipline measures taken by DBV, in particular the decrease in personnel expenses, which is directly related to the workforce reduction DBV implemented during its global restructuring plan. As a result of the ongoing COVID-19 pandemic, DBV also experienced decrease in other expenses, in particular tradeshows and travel expenses.
Restructuring Costs: restructuring costs, related to DBV’s global restructuring plan announced on June 26, 2020, were $23.6 million under U.S. GAAP and $23.0 million under IFRS for the year ended December 31, 2020, which costs include severance-related expenses, restructuring-related consulting and legal fees and expenses related to impairment of facilities and rights of use assets. DBV expects that the global restructuring plan, which includes significant headcount reductions that DBV anticipates completing by the end of the first quarter of 2021, will result in a remaining global team of 90 individuals. DBV had no restructuring costs in 2019.

Net Loss: Under U.S. GAAP net loss was $(159.6) million for the year ended December 31, 2020, compared to $(172.0) million for the year ended December 31, 2019. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(2.95) and $(4.65) for the years ended December 31, 2020 and 2019, respectively. Under IFRS, net loss was $(159.4) and $(172.5) million for the years ended December 31, 2020 and 2019, respectively, and net loss per share was $(2.95) and $(4.66) for the years ended December 31, 2020 and 2019, respectively.
DBV will host a conference call and live audio webcast on Thursday, March 11, 2021, at 5:00 p.m. ET/11:00 p.m. CET to discuss financial results for the year ended December 31, 2020 and to provide a general corporate update on the status of Viaskin Peanut in the US and EU.

This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50114481.

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.