On March 18, 2021 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA; the "Company") reported that ILLUMINATE-301, the Company’s pivotal registration trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate (ORR) (Press release, Idera Pharmaceuticals, MAR 18, 2021, View Source [SID1234576870]). Idera is evaluating its next steps regarding continuation of the trial toward its overall survival (OS) endpoint, which includes evaluating the full data set when it is available. The Company also plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer (MSS-CRC).

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ILLUMINATE-301 is a randomized, global, multi-center, open label Phase 3 trial comparing the efficacy of 8 mg intratumoral tilsotolimod in combination with 3 mg/kg ipilimumab versus 3 mg/kg ipilimumab alone in 481 patients with anti-PD-1 refractory advanced melanoma. The trial has a primary endpoint family of ORR per RECIST v1.1 and OS. Although the primary endpoint of ORR was not met, if the study continues and reaches a positive OS outcome, the Company would expect to discuss with regulatory authorities a potential path forward in this indication.

ILLUMINATE-301 Key Findings:
Patients in the study were randomized and treated either with 8 mg of tilsotolimod in combination with ipilimumab or with ipilimumab alone. Topline results include:

ORR of 8.8% for the combination arm and 8.6% for ipilimumab alone.
Disease control rate (DCR, defined as stable disease or better) of 34.5% for the combination and 27.2% for ipilimumab alone.
Treatment-emergent adverse events (TEAEs) (Grade 3 and above) occurred in 61.1% of patients who received the combination vs. 55.1% of patients who received ipilimumab alone. Immune-related TEAEs (Grade 3 and above) were reported in 37.6% vs. 30.1%, respectively.
More detailed results from ILLUMINATE-301 may be submitted for future publication or presentation.

"We are surprised and disappointed that the response data from ILLUMINATE-301 do not lead us to an accelerated path to a new and much-needed treatment option for these patients," stated Vincent Milano, Idera’s Chief Executive Officer. "We would like to extend our deepest gratitude to everyone involved in this study, especially the many courageous patients who participated and continue in follow up."

Continued Mr. Milano, "Despite today’s news, we are continuing to explore tilsotolimod via our ongoing ILLUMINATE-206 study in order to understand its potential to lead to better outcomes for patients with MSS-CRC."

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.

About Anti-PD-1 Refractory Advanced Melanoma
Melanoma is a cancer that begins in a type of skin cell called melanocytes. While melanoma is the least common type of skin cancer, it has a poor prognosis when not detected and treated early. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread, or metastasized, beyond the skin to other parts of the body. According to the American Cancer Society, approximately 100,000 people in the US will be diagnosed with invasive melanoma this year. In recent years, immunotherapies known as CPIs have changed the treatment of advanced melanoma, with anti-PD-1 agents, alone or in combination with anti-CTLA-4, being the most commonly used immunotherapy in the first-line setting. These agents work by increasing the ability of the body’s immune system to help detect and fight cancer cells. However, due to primary or acquired resistance mechanisms that exclude or inhibit anti-tumor immune cells, as many as 60% of patients may not benefit from this type of therapy when used as monotherapy, and up to one-third of initial responders may develop resistance to the therapy and ultimately experience disease progression. Today, these refractory patients are left with few options for further treatment, paving the way for novel investigational therapies such as tilsotolimod.

About MSS-CRC
Colorectal cancer involves the abnormal growth of cells in the colon or rectum. This type of cancer is typically tested to determine its "MSI" status, which will inform treatment approach and prognosis. MSI stands for "microsatellite instable." MSI-High (MSI-H) means that there is a high amount of instability in a tumor, whereas MSS tumors are "microsatellite stable." The American Cancer Society estimates that, annually in the United States, approximately 140,000 people are diagnosed with CRC, of which 85% are MSS, and approximately 50,000 people die due to CRC. MSS-CRC has been shown to be highly immunosuppressive; there are no approved immunotherapy options, and a prior trial of ipilimumab plus nivolumab (Bristol Myers Squibb’s CheckMate 142) yielded overall response rates of 0-10%. Given tilsotolimod’s mechanism of action of activating dendritic cells and therefore triggering innate and adaptive immune responses, it may serve a complementary function to ipilimumab and nivolumab within the immunosuppressive tumor microenvironment of MSS-CRC patients.

On March 18, 2021 Aktis Oncology, a biotechnology company discovering and developing a novel class of targeted radiopharmaceuticals to treat a broad range of solid tumor cancers, reported completion of a $72 million Series A financing (Press release, Aktis Oncology, MAR 18, 2021, View Source [SID1234576886]). The company was founded and incubated by MPM Capital, which co-led the financing with EcoR1 Capital and Vida Ventures, with participation from Octagon Capital, TCG Crossover, Novartis and Bristol Myers Squibb.

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"Aktis Oncology is building on recent successes in the radiopharmaceutical field, using a novel approach to extend the efficacy of targeted radiopharmaceuticals into a wide range of solid tumors," said Todd Foley, Chairman of Aktis Oncology, and Managing Director of MPM Capital. "We’re incredibly excited by the science, the team and a world class syndicate of institutional and strategic investors that share in our vision to realize the potential of targeted radiotherapy to become a mainstream anti-cancer modality."

Aktis Oncology is developing novel alpha radiotherapies to improve upon the efficacy of conventional solid tumor therapies, while limiting toxicity. The company has developed proprietary platforms to discover best-in-class tumor targeting agents designed with optimal pharmacology for delivering alpha radiotherapy. Aktis Oncology targeting agents are highly tumor penetrant but clear from other areas of the body quickly, to maximize tumor elimination while minimizing potential side effects of treatment.

"Alpha radiotherapy is the future of radiopharmaceuticals," said Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. "By harnessing the power of alpha particles – with nearly 1000 times the potency of beta particles – we believe our approach has the potential to deliver game-changing results for patients."

Aktis Oncology’s theranostic approach would also enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes, allowing for better selection of patients most likely to benefit from therapy. The company plans to produce multiple development candidates with potential for efficacy against well-validated cancer targets.

Aktis Oncology was founded by Brian Goodman, PhD, Patrick Baeuerle, PhD, and Todd Foley, of MPM Capital. The company is led by:

Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. He is an Executive Partner of MPM Capital, and serves as Chairman of Turmeric Acquisition Corporation, and is a member of the boards of iTeos Therapeutics and NextPoint Therapeutics. Prior to joining MPM, Dr. Roden held senior leadership positions in the biopharma industry, most recently as Senior Vice President and Head of Enterprise Strategy at Bristol Myers Squibb; he held senior roles in the capital markets, including serving as head of biotechnology equity research at UBS and as a senior biotechnology equity analyst at J.P. Morgan; and has scientific training in immunology, structural biology, and cancer biology.
Paul Feldman, PhD, Chief Scientific Officer of Aktis Oncology. Prior to joining Aktis Oncology Dr. Feldman was the Head of Discovery and Translational Medicine at Intarcia Therapeutics. An accomplished drug discoverer and executive in the biopharmaceutical industry, he previously served as Senior Vice President at GlaxoSmithKline, leading the Enteroendocrine Discovery Performance Unit and GSK’S enterprise Chemistry Council, before retiring to co-found Phoundry Pharmaceuticals, a peptide hormone therapeutic company.
Brian Goodman, PhD, Head of Operations and Corporate Development of Aktis Oncology. As part of the Investment and Operations Team at MPM Capital, he is responsible for investment identification, due diligence, business development, and new company creation at a number of MPM portfolio companies. He serves as a board observer for Orna Therapeutics and Triplet Therapeutics. Prior to joining MPM Capital, Dr. Goodman co-founded and served as Head of Technology and Innovation at Evelo Biosciences, a company focused on the pharmacology of microbial drugs across multiple therapeutic areas; and was a Senior Associate at Flagship Pioneering.
Aktis Oncology is headquartered in Cambridge, Mass. with laboratory operations in Research Triangle Park, NC.

On March 18, 2021 Swedish-based Newbury Pharmaceuticals AB, a hybrid pharmaceutical company for specialty prescription drugs, innovation and brands, has successfully completed its Series A funding round of 25 MSEK (Press release, Newbury Pharmaceuticals, MAR 18, 2021, View Source [SID1234632241]).

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The oversubscribed Series A financing brings 25 MSEK from selected strategic investors. Proceeds from the funding round will support to continue building a pipeline of proprietary and licensed products. The portfolio strategy includes niche and value-added small molecules, product development based on peptide technology as well as biosimilars in a variety of therapeutic categories.

"We have the ambition to become the local champion and alternative partner to the multinationals. We strive to have a positive impact in the society, bring products and technology that contribute to the overall healthcare system and patient’s wellbeing – and give our partner the local attention they deserve" says Karl Karlsson, Founder & CEO.

On March 18, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2020 (Press release, Innate Pharma, MAR 18, 2021, View Source [SID1234576848]). The consolidated financial statements are attached to this press release.

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"In 2020, we made the strategic decision to re-prioritize our investments in our R&D portfolio, enabling us to concentrate our resources and further strengthen our clinical pipeline," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Our priority going forward is to advance the clinical development of our lead proprietary candidate, lacutamab, as well as leverage our multispecific NKCE antibody platform, to create potential innovative therapeutics for patients and provide long-term value to our shareholders."

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

The TELLOMAK Phase 2 clinical trial, which is evaluating the efficacy and safety of lacutamab in patients with advanced cutaneous T-cell lymphomas, is now fully open to enrollment in countries that had a partial regulatory hold following the successful resolution of Good Manufacturing Practice issues.
In November, the Company announced that the European Medicines Agency (EMA) granted PRIME designation to lacutamab for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. This is the first time PRIME designation has been granted for a potential treatment of any sub-type of T-cell lymphoma. This follows the Fast Track designation that was awarded to lacutamab by the U.S. Food and Drug Administration in 2019.
In February 2021, the Company announced lacutamab demonstrated a positive early signal in cohort 2 of KIR3DL2-expressing mycosis fungoides patients in the TELLOMAK clinical trial earlier than anticipated. This cohort reached the pre-determined number of responses needed to advance to stage 2. The Company plans to present this preliminary data at a scientific meeting in 2021.
The Company will initiate two parallel clinical trials to study lacutamab in KIR3DL2-expressing patients with relapsed/refractory peripheral t-cell lymphoma (PTCL):
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) will launch an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory patients.
IPH6101 (NKp46-based NK cell engager), partnered with Sanofi:

Progress was made in the NKCE collaboration with Sanofi, resulting in the decision announced in January 2021 that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. IPH6101 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. Cell 2019). The decision triggered a €7 million milestone payment from Sanofi to Innate.
In January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

In October 2020, AstraZeneca (LES/STO/Nasdaq: AZN) dosed the first patient in its randomized Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab vs. placebo and cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. Dosing of the first patient in this trial triggered a $50 million milestone payment from AstraZeneca to Innate. Innate is eligible to receive an additional $50 million milestone payment after the interim analysis demonstrates the combination meets a pre-defined threshold of clinical activity. To date, the Company has received a total of $400 million from the AstraZeneca partnership for monalizumab.
The Company presented efficacy data on the Phase 2 expansion cohort investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Conference held in May 2020. This data showed an overall response rate in line with previously reported data and a manageable safety profile. The Company presented updated results at the ESMO (Free ESMO Whitepaper) Immuno-oncology Virtual Congress in December 2020.
In 2020, the Company expanded a Phase 2 expansion cohort ("cohort 3"), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with R/M SCCHN, from 20 to 40 patients. Recruitment for cohort 3 is complete, and the Company expects to publish data in 2021.
Avdoralimab in Inflammation (anti-C5aR1 antibody):

• In November 2020, the first patient was dosed in the investigator-sponsored Phase 2 clinical trial in bullous pemphigoid (BP) where the C5aR1 pathway has been shown to be involved in the physiopathology of the disease. The trial is investigating the clinical efficacy of avdoralimab in addition to topical steroids compared to topical steroids alone in BP patients.

Avdoralimab in COVID-19:

The investigator-sponsored Phase 2 clinical trial, FORCE (FOR COVID-19 Elimination), has completed enrollment and is ongoing for patient follow-up and data analysis. More information on this study can be found at clinical trials.gov.
Results from the exploratory translational EXPLORE study supporting this trial were published online in Nature on July 29, 2020.
The investigator-sponsored Phase 2 clinical trial, ImmunONCOVID-20, has resumed, and is currently recruiting. This study is exploring the potential efficacy of monalizumab and avdoralimab amongst other treatment arms, against COVID-19 in cancer patients with mild symptoms and pneumonia respectively.
In August 2020, the Company announced it obtained €6.8 million in public funding from the French government for its COVID-19 R&D activities. This funding is part of the government’s PSPC COVID call for COVID-19 related projects and will enable the Company to cover the development of its current COVID-19 activities, which began in March 2020, including the EXPLORE COVID-19 translational research study and its two Phase 2 clinical trials, FORCE and ImmunONCOVID-20.
Avdoralimab in Oncology:

• In September 2020, the Company announced the decision to stop enrollment in STELLAR‑001, a Phase 1 dose escalation and expansion study in combination with durvalumab in three expansion cohorts: 1) NSCLC patients with secondary resistance to prior immuno-oncology (IO) treatment; 2) IO-naïve HCC patients; and 3) IO-pretreated HCC patients. The decision was made based on the data from the Company’s cohort expansions in NSCLC and IO-naïve HCC.

IPH5201 (anti-CD39 antibody), partnered with AstraZeneca:

• In February 2020, the AstraZeneca sponsored, multicenter, open-label, dose-escalation Phase I trial evaluating IPH5201 as monotherapy or in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73) in advanced solid tumors started. Following the dosing of the first patient in the trial on March 9, 2020, AstraZeneca made a $5 million milestone payment to Innate under the companies’ October 2018 multi-product oncology development collaboration. Innate made a €2.7 million milestone payment to Orega Biotech SAS pursuant to Innate’s exclusive licensing agreement.

Lumoxiti (CD22-directed immunotoxin):

In December 2020, the Company announced that it will return the US and EU commercialization rights of Lumoxiti (moxetumomab pasudotox-tdfk) to AstraZeneca3. Innate licensed the US and EU rights to AstraZeneca’s FDA-approved Lumoxiti for certain patients with relapsed or refractory hairy cell leukemia in October 2018.
Innate and AstraZeneca are currently in discussions regarding the transition plan for the transfer of the US marketing authorization and distribution of Lumoxiti to AstraZeneca, including timing and costs (see Contingent liabilities).
Corporate Update:

In July 2020, Dr. Joyson Karakunnel was appointed as Executive Vice President and Chief Medical Officer (CMO). Dr. Pierre Dodion, CMO since 2014, retired from this position. Dr. Karakunnel comes to the Company with deep experience in immuno-oncology, and a proven track record in drug development. Most recently, Dr. Karakunnel served as CMO and Senior Vice President at Tizona Therapeutics, where he led the development of the company’s biotherapeutics pipeline.
Laure-Helene Mercier, Executive Vice President, Chief Financial Officer and member of the Executive Board, has decided to step down from her position, after leading the Company through more than 14 years of growth, including an initial public offering in the US. Frederic Lombard will join the company as CFO on April 1, 2021. Mr. Lombard will be joining Innate with more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Ms. Mercier will remain at the Company until the end of the year to ensure a smooth transition of responsibilities.

Financial highlights for 2020:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2020 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €190.6 million (€m) as of December 31, 2020 (€255.9m as of December 31, 2019), including non-current financial instruments amounting to €38.9m (€37.0m as of December 31, 2019).
Cash and cash equivalents include the milestone payment of $50.0m (€41.2m) following the inclusion by AstraZeneca of the first patient in its Phase 3 randomized clinical trial evaluating monalizumab, INTERLINK-1. It doesn’t include the milestone payment of €7.0m from Sanofi relating to the progress of IPH6101/SAR443579 into new drug (IND)-enabling studies, received in February 2021.
As of December 31, 2020, financial liabilities amount to €19.1m (€18.7m as of December 31, 2019). This change is partly linked to the receipt, in August 2020, of €1.4m in repayable advance in connection with the financing contract signed with BPI Financement (COVID-19).
Revenue and other income amounted to €70.5m in 2020 (2019: €85.8m, -17.9%). It mainly comprises revenue from collaboration and licensing agreements (€56.2m in 2020 vs €69.0m in 2019, -18.6%), and research tax credit (€13.1m in 2020 vs €16.7m in 2019, -21.8%):
Revenue from collaboration and licensing agreement with AstraZeneca amounted to €49.0m in 2020 (€69.0m in 2019, -29.0%) and mainly resulted from (i) the spreading of the upfront and opt-in payments received from AstraZeneca and (ii) the invoicing to AstraZeneca of certain fees for the work performed by Innate for the partnered programs. The variation between the two periods is notably explained by the completion of (i) the recruitment of the Cohort 2 in the monalizumab Phase 2 trials performed by Innate in 2019, and (ii) the preclinical work related to the Phase 1 program of IPH5201, which started in 2020.
Revenue of €7.0m from Sanofi for the progress of IPH6101/SAR443579 into investigational new drug (IND)-enabling studies.
The variation in the research tax credit mainly results from a decrease in the amortization for the intangible assets related to acquired licenses (monalizumab, IPH5201).
Operating expenses of €89.9m in 2020 (2019: €104.6m, -14.1%):
Selling, general and administrative (SG&A) expenses amounted to €31.2m in 2020 (2019: €25.8m, +21.1%). This increase mainly results from the full-year effect of personnel costs related to our US subsidiary, including personnel assigned to Lumoxiti commercial activities.
R&D expenses amounted to €58.6m in 2020 (2019: €78.8m, -25.7%). This variation mainly results from a decrease in direct R&D expenses (mainly related to Lumoxiti, IPH5201 and IPH5301) and in depreciation and amortization of intangible assets acquired by the Company (IPH5201 and monalizumab).
Lumoxiti intangible asset full impairment of €43.5m, following the Company’s decision to return the US and EU commercialization rights of Lumoxiti to AstraZeneca.
The Lumoxiti distribution agreement generated a net income of €0.9m in the first three quarters of 2020 (a net loss of €8.2m in 2019). During the 2020 fourth quarter, the Company recognized net sales from Lumoxiti of €0.7m.
A net loss of €64.0m in 2020 (2019: net loss of €20.8m).

On March 18, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:BIMUF), a biotechnology company that specializes in cancer, cannabinoids, and Covid-19 reported the closing of the second tranche of the non-brokered private placement announced on November 2, 2020, January 19, 2021 and January 22, 2021 (the "Private Placement") (Press release, Pascal Biosciences, MAR 18, 2021, View Source [SID1234576871]). Participants included long-term shareholders, new shareholders, and Company insiders. "This financing will greatly help Pascal move our programs forward. It’s encouraging to see the confidence of our long term shareholders and we welcome our new shareholders", stated CEO Patrick Gray. "Mark van der Horst, our vice president of Corporate Communications, has done a great job of presenting the Pascal story, and we will continue to actively deliver positive messaging to investors."

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The second tranche consists of 1,900,000 units (each a "Unit") for gross proceeds of $190,000. The first tranche closed on February 8, 2021 and the Company issued 5,600,000 Units for gross proceeds of $560,000. Each Unit consists of one common share in the capital of the Company (each a "Share") and one Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder to purchase one additional Share at a price of $0.15 per Share for a period of 24 months from the date of closing, subject to an exercise acceleration clause. Under the exercise acceleration clause, which the Company may exercise once the Units are free of resale restrictions and if the Company’s Shares are trading at or above a volume weighted average price of $0.40 for 10 consecutive trading days, the Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release.

The Company paid $1,365 in finder’s fees related to the second tranche of the Private Placement.

Certain directors and officers of the Company acquired 1,255,000 Units under the Private Placement. Any such participation is considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business.

The securities issued under the Private Placement are subject to a four-month and one day hold period. The private placement is subject to final acceptance by the TSX Venture Exchange upon filing of final documents.