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12/02/2020 13:32:09 0.18 14,900
12/02/2020 13:32:08 0.18 12,660
Liquidity
As of September 30, 2020, the Company’s cash amounted to $7.3 million and current liabilities amounted to $6.6 million. The Company had expended substantial funds on its clinical trials and expects to continue our spending on research and development expenditures. Our net losses incurred for the three months ended September 30, 2020 and 2019, amounted to $1.2 million and $1.6 million, respectively, and we had a working capital of approximately $0.7 million at September 30, 2020 and a working capital deficit of approximately $(1.2) million at June 30, 2020.
On July 31, 2020, the Company entered into a new common stock purchase agreement (the “2020 Agreement”) with Aspire Capital which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of the Company’s common stock over the 24-month term of the Agreement. In consideration for entering into the 2020 Agreement, the Company issued to Aspire Capital 6,250,000 shares of its Class A Common Stock as a commitment fee. The commitment fee of approximately $1.4 million was recorded as deferred financing costs and additional paid-in capital and this asset will be amortized over the life of the 2020 Agreement. As of September 30, 2020, the available balance is $27.1 million.
We anticipate that future budget expenditures will be approximately $10.3 million for the fiscal year ending June 30, 2021, including approximately $8.3 million for clinical activities, supportive research, and drug product. Alternatively, if we decide to pursue a more aggressive plan with our clinical trials, we will require additional sources of capital during the fiscal year 2021 to meet our working capital requirements for our planned clinical trials. Potential sources for capital include grant funding for COVID-19 research and equity financings. There can be no assurances that we will be successful in receiving any grant funding for our programs.
Management believes that the amounts available from Aspire Capital and under the Company’s effective shelf registration statement will be sufficient to fund the Company’s operations for the next 12 months.
“BRILACIDIN HAS A HIGH LIKELIHOOD OF REACHING COMMERCIALIZATION.” — Dr. Michael Zasloff
http://www.ipharminc.com/brilacidin-1
Dr. Michael Zasloff
http://ir.amphastar.com/board-directors/michael-zasloff
Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno / anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate.
https://www.precisionvaccinations.com/fda-agrees-defensin-mimetic-drug-candidate-study-covid-19
Awesome, thanks for sharing.. Go LEO!!
Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial
Innovation Pharmaceuticals Inc.
Mon, November 2, 2020, 8:25 AM CST·7 mins read
Company finalizing Brilacidin protocol; clinical study anticipated to commence in 4Q2020
WAKEFIELD, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today receipt of written feedback from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company’s planned clinical trial for Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19. The FDA response completes the Pre-Investigational New Drug (Pre-IND) process.
The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. The Company is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment for the trial is 120 patients. Contract Research Organizations have been secured to expedite trial enrollment with many clinical sites expressing interest in participating in the study. The Company anticipates commencing the Brilacidin for COVID-19 clinical trial in 4Q2020.
“Getting to the point of being able to advance Brilacidin as a potential treatment for COVID-19 required an enormous amount of time, resources, and team effort,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “From the manufacturing of drug supply, to researching Brilacidin’s mechanisms of action in vitro against SARS-CoV-2 in infected cells, to now preparing and planning for the COVID-19 clinical study—was an extraordinary effort.”
Ehrlich added: “We are extremely grateful for the hard work of our employees, consultants and affiliated researchers. While no one can predict with certainty how Brilacidin will perform in clinical testing against COVID-19, we are optimistic based on the compelling preclinical antiviral data we have released and Brilacidin’s consistently successful results in other clinical trials. Our hope is Brilacidin for COVID-19 can be an important part of the solution to help rid the world of this deadly coronavirus.”
Brilacidin COVID-19 Preprint
The Company, based on pre-clinical research conducted in collaboration with George Mason University, has released a preprint, prior to formal peer review submission, demonstrating Brilacidin’s COVID-19 treatment potential. The preprint can now be downloaded on bioRxiv.org at the link below.
Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate.
Also, In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
"Previous publications have demonstrated ability to selectively suppress harmful immune responses using complicated gene modification technology1," said Timothy Warbington, CEO. "The data disclosed suggest ability of ImmCelz® to achieve superior results in a manner which is amenable to rapid clinical translation."
"It is our goal to continue to bring our robust Allogenic Stem Cell programs through patent issue, thus creating a barrier of entry to competition, compilation of data for proof of concept, early stage trial(s) via FDA Investigational New Drug applications (IND) and to continue to seek out collaborators, potential licensees and/or joint venture partners from larger life science companies within our space," said Donald Dickerson, Chief Financial Officer of the company.
ImmCelz®
CaverStem®
FemCelz®
OvaStem®
StemSpine®
AmnioStem®
TregCelz™
https://www.biospace.com/article/releases/creative-medical-technology-holdings-reports-positive-preclinical-data-on-immcelz-immunotherapy-product-in-rheumatoid-arthritis-model/
https://thefly.com/news.php?symbol=IPIX .. You've missed something.
COMMON STOCK PURCHASE AGREEMENT (the “Agreement”), is dated as of July 31, 2020
https://www.sec.gov/Archives/edgar/data/1355250/000147793220004521/ipix_ex101.htm
https://www.sec.gov/Archives/edgar/data/1355250/000147793220004521/ipix_8k.htm
Aspire Capital Fund, LLC
https://www.aspirecapital.com/about-us
Innovation’s Brilacidin shows promise in-vitro against Covid-19
Innovation Pharmaceuticals has reported promising data from ongoing in-vitro testing of its Brilacidin at a US Regional Biocontainment Laboratory (RBL) to treat Covid-19.
Data showed that Brilacidin has a high selectivity index (SI), used to compare the antiviral efficacy between investigational drugs.
In a human lung epithelial cell line, the drug’s SI proved greater than 300, higher than the SIs of a majority of other antiviral drugs tested against Covid-19, said the company.
Innovation Pharmaceuticals CEO Leo Ehrlich said: “Selectivity Index is arguably the most important measure to compare the antiviral efficacy between experimental drugs, and this new data suggests Brilacidin is in an elite group of anti-coronavirus candidates.
“Unlike thousands of other compounds and drugs under consideration as Covid-19 treatments, Brilacidin is demonstrating remarkably consistent and potent anti-SARS-CoV-2 activity in RBL testing, suggesting Brilacidin has tremendous potential as a Covid-19 treatment.”
With direct incubation of the live (or wild type) virus, the drug caused inhibition by 50% (IC50 value) at a mid-nanomolar concentration, in a human lung epithelial cell line.
Findings also revealed that the drug was non-cytotoxic to cells at high micromolar concentrations. Brilacidin’s IC90 value was in the low micromolar range.
A recent screening of 5,632 compounds, including 3,488 subjected to clinical-stage testing across 600 indications, only 19 possessed an IC50 in the nanomolar (<1µM) range against Covid-19, demonstrated by Brilacidin.
The company intends to speed-up planned clinical testing of its drug for Covid-19 treatment, including the selection of clinical trial sites. Discussions with the US Food and Drug Administration (FDA) should begin early next month.
Production of intravenous (IV) drug product could generate an amount above the estimated requirement for the planned Phase II trial, allowing extra support for further Covid-19 clinical testing.
https://www.pharmaceutical-technology.com/news/innovation-brilacidin-preclinical/
Treatment of COVID-19: Evidence of current drugs in use
http://praxisug.com/index.php/Praxis/article/view/90/67
Brilacidin is on page 59
Innovation Pharmaceuticals – Clinical Trial Testing of Brilacidin Against SARS-CoV-2 (COVID-19) Targeted to Commence Q4 2020
July 13, 2020 08:00 ET | Source: Innovation Pharmaceuticals Inc.
WAKEFIELD, Mass., July 13, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provides perspectives on the planned clinical trial testing of Brilacidin, administered intravenously (IV), for the treatment of COVID-19. The exigencies of the pandemic coupled with Brilacidin’s multiple therapeutic properties – its anti-viral SARS-CoV-2 activity, its anti-inflammatory potential to abate the COVID-19 associated cytokine storm, as well as its proven anti-bacterial properties – have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020.
As previously released, manufacturing steps are now underway to prepare Brilacidin for COVID-19 clinical trial use, including the sourcing of materials and making of sterile IV drug product. In parallel to these manufacturing efforts, the Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. This proposed study has two active treatment arms evaluating different IV dosing regimens in hospitalized patients with COVID-19. The ongoing in vitro testing at independent laboratories of Brilacidin against SARS-CoV-2, in which Brilacidin has shown consistently robust results in human and animal cell lines, is helping to inform trial design.
Given the continuing coronavirus pandemic, and especially in light of surging cases in the United States, the Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020. This forecast assumes manufacturing is completed, per the manufacturer’s timeline, and a successful Investigational New Drug (IND) application with the Food and Drug Administration.
“The spread of COVID-19 only seems to be getting worse, a truly worrisome trend, with reports of possible reinfection occurring more frequently,” noted Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. “We continue to work diligently, engaged now in preclinical testing activities, as the world so desperately needs a solution for this pandemic. Getting Brilacidin into the clinic to help treat COVID-19 patients continues to be a primary focus of the Company and our hope is that Brilacidin will be an integral part of the solution.”
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support Brilacidin’s potential to inhibit IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
https://www.globenewswire.com/news-release/2020/07/13/2061196/0/en/Innovation-Pharmaceuticals-Clinical-Trial-Testing-of-Brilacidin-Against-SARS-CoV-2-COVID-19-Targeted-to-Commence-Q4-2020.html
Revenue of $58.5 million, up 28% year over year..
https://investors.limelight.com/file/Index?KeyFile=404677197
Limelight Networks Reports Strong Financial Results for the Second Quarter of 2020
https://investors.limelight.com/file/Index?KeyFile=404677197
I like the future here. Nice volume the last 2 days..
Proposed Targets/Mechanisms of Action of Brilacidin Against SARS-CoV-2
1) Antiviral—Virucidal Property (pre-infection, disrupting the viral envelope/destroying the virus)
2) Antiviral—Blocking Property (pre-infection, preventing viral attachment/viral entry to host cells)
3) Antiviral—Inhibitory Property (post-infection, interfering with viral replication intracellularly)
4) Anti-Inflammatory Property (post-infection, suppressing IL-6 and other pro-inflammatory mediators implicated in Severe Acute Respiratory Syndrome)
5) Anti-Bacterial Property (post-infection, helping to resolve secondary infections that can affect up to 20 percent of COVID-19 patients)
In a previous Phase 2b clinical trial, Brilacidin was proven to have potent bactericidal properties against difficult Gram-positive Infections (ABSSSI), including methicillin-resistant Staph aureus (MRSA). (See above #5).
Exhibiting multiple antiviral mechanisms of action and other complementary therapeutic properties would likely greatly enhance Brilacidin’s efficacy against SARS-CoV-2 (COVID-19) while decreasing the chances of mutational-driven resistance to the drug.
Research and evaluation of Brilacidin against SARS-CoV-2 using both VERO and human cells continues at the RBL. The Company’s expects to release data on multiple studies over the coming weeks.
http://www.ipharminc.com/new-blog/2020/5/21/brilacidin-for-covid-19-proposed-targets-and-mechanisms-of-action-against-sars-cov-2
Great post. Thanks
Biotricity Reports Fiscal Q1 Results Showing A Strong Growth Trajectory
https://finance.yahoo.com/news/biotricityreports-fiscal-q1-resultsshowinga-strong-120000741.html
CEO and Founder Waqaas Al-Siddiq was on Yahoo Finance's On the Move show. All positive hopefully.. Busy work week, any feedback from the show would be appreciated. TIA
$CLSK $0.77..Today's volume of 495,713 shares is on pace to be much greater than CLSK's 10-day average volume of 107,920 shares.
$BTCY $0.65 +0.05 (8.33%)
$0.932 New 52 week low
$CLSK $1.14 -0.09 (-7.32%)
Biotricity Audited Year-End Results Demonstrate Execution of Commercial Growth Plans
https://finance.yahoo.com/news/biotricity-audited-end-results-demonstrate-120000800.html
$CLSK $1.37 -.037 (-21.26%)
$BTCY Entry into a Material Definitive Agreement.
Between July 9, 2019 and July 11, 2019, Biotricity, Inc. (the “Company”) sold to four accredited investors a total of $500,000 (the “Holders”). The notes mature twelve months from the date of issuance. The Notes bear an interest rate of 10%, which is to be paid quarterly in arrears.
Pursuant to the subscription agreement between the Company and the Holders, the Notes may be convertible subject to mutual agreement of the Company and the Holders of the Notes at a 20% discount to the next equity financing of greater than $5,000,000 excluding the conversion of the Notes.
The Notes referenced above were offered and sold pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act since, among other things, the transactions did not involve a public offering.
Copies of the forms of the subscription agreement and promissory note are attached hereto as exhibits to this Current Report. The foregoing description of the material terms of the subscription agreement and promissory notes are qualified in their entirety by reference by such exhibits.
NO 10-K.. LATE - LATE.. When? Why!!..
Notification That Annual Report Will Be Submitted Late (nt 10-k) LOL
I'm in. Lets bring home the bacon. GLTA
Pump PR.. Where's the earnings report? When will it be released?