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Who is this, and what's she doing here?
On September 1, 2018, the Company also issued to Ms. Anne Ponugoti, Associate Director, Clinical Sciences of the Company, 5,000 shares of the Company’s common stock and 5,000 options to purchase common stock with same vesting periods as the common stock and options issued to Ms. Ponugoti. The total value of the 5,000 shares and 5,000 options were approximately $2,000 each, based on the closing bid price as quoted on the OTC on August 31, 2018 at $0.40 per share. During the three months and nine months ended March 31, 2019, the stock-based compensation expense was not significant. She left the Company on January 15, 2019.
(apologies... just noticed that BooDog had posted elsewhere that she'd signed-on in 2017. First time I've noticed her mentioned in a 10-Q in the last several years)
AI work is here for sure, my friend...
...at least in its relative infancy.
This is a friend of mine's company: www.EvolScience.com
I've been interested in the tech for a while now, and the opportunities it presents to remove human error, shortening trial-time and expense etc.
Seems like IPIX could benefit from reduced cost measures by running some things virtually in a trial-setting for sure.
My concerns within this space are reflected in news like this today:
https://endpts.com/achaogens-bankruptcy-and-going-out-of-business-sale-offer-a-grim-cautionary-tale-for-the-future-of-antibiotic-development/
'The lights are winking out at Achaogen, offering another cautionary tale that will make it even less likely we’ll see new companies come along to develop antibiotics — even as drug-resistant strains of bacteria pose a rising threat to the world’s population.'
'On Monday, the South San Francisco-based biotech filed for Chapter 11 bankruptcy, setting up an auction for its assets, which primarily center on their recently approved antibiotic Zemdri — which boasted an ability to tackle carbapenem-resistant Enterobacteriaceae, the CDC’s “nightmare bacteria.” Its stock $AKAO, already deep in penny land, fell 68% to 16 cents a share, which underscores just what investors think that’s worth now.'
Have a read through the article. It's insightful
Author Copyright is: John Carroll from Endpoints News
Krobar- Have a look at the data from 8 Dec 2014, and run the numbers.
Zero revenue and nothing significant in the bank then to speak of... but you can calculate the P/E based on what showed up that day.
Also, note the volume.
This should help with your question concerning 'a partnership returning it to those levels'.
Yes, we're double+ the OS currently, but depending on terms, it may not matter.
I'm guessing you're familiar with P/E's in the sector, which I think will be the only way this sees what we're hoping for, given what I suspect will be included in upfront payments for B-OM partnership.
I guess we'll see... keep the fingers crossed.
Shareholder Alert (email):
They just sent this info out via email.
It's rehashed from their FLS update a while back. (so redundant, and not sure why they're sending)
We need cash, not more BS...
Brilacidin – Competitive Positioning, Market Opportunity for Oral Mucositis
Competitive Positioning
Based on our preliminary estimates, the total Brilacidin oral mucositis market opportunity in Head and Neck Cancer annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.
In follow-up to today’s Press Release, the Company wanted to provide shareholders with additional perspectives on the competitive positioning and market opportunity of Brilacidin oral rinse for use in Head and Neck Cancer (HNC) patients undergoing chemoradiation. Compared to other oral mucositis (OM) drug candidates being evaluated in clinical testing, Innovation Pharmaceuticals believes its drug candidate, Brilacidin oral rinse, occupies a leadership position as preparations move forward for its planned Phase 3 program. Most potential competitor drug candidates target minimizing symptoms and not prevention, and/or are disadvantaged by not having as patient-friendly modes of delivery (IV) in comparison to our easily-administered oral rinse. For detailed comparative analysis, please see our Company blog post on the topic, linked below:
http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs
Market Opportunity (HNC-Only, US and Europe)
According to published statistics, and based on other data sources, oral mucositis accompanies chemoradiation treatment in almost all Head and Neck Cancer patients undergoing treatment. The annual incidence of HNC in the US and Europe is approximately 150,000 (worldwide approximately 750,000 cases). Approximately 60 to 70% of these patients will develop Severe Oral Mucositis (SOM) (WHO Grade > 3) (confirmed in our own clinical study). Because it cannot be predicted which patients will get SOM, all patients would begin Brilacidin as soon as starting chemoradiation and continue until completion (typically a seven-week course). Given that Brilacidin is administered as a convenient and patient-friendly oral rinse (swish and spit, 3x daily), we believe that our market penetration could realistically approach 80 percent within the first three years following market introduction. This would translate into a targeted 120,000 treated HNC patients in the U.S. and Europe per year according to the anticipated label indication. Moreover, following regulatory approval in HNC, we would anticipate the potential to expand the label to capture a broadened market—patients experiencing OM across various cancer indications, estimated to include as many as 650,000 people annually (25% to 60% of all cancer patients receiving chemotherapy experience OM).
We believe most other competitor products in development, with less patient-friendly modes of delivery (e.g., IV), would be less able to reach this broader OM market. An additional factor that should help to expedite market adoption of Brilacidin oral rinse includes the potential to avoid incremental inpatient costs incurred in those SOM patients requiring hospitalization, estimated to be between $18,000 and $25,000 per incident. Private and government payers would thus be incentivized to adopt preventative treatment due to large potential cost-savings. We anticipate being able to price Brilacidin at $5,000 to $10,000 per full course of treatment based on the large unmet need as well based on initial pricing for the only other OM drug ever approved (Palifermin, hematopoietic stem cell transplantation, HSCT). Based on our preliminary estimates, the total Brilacidin oral rinse market opportunity annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.
He has no financing... that's why i'm saying it won't work.
Companies with terrible fundamentals at best, should've even breathe the letters 'RS'.
RS is a shell-game.
All that does is rearrange the deck chairs on the Titanic at this point.
If nothing else, an accountant (Leo) should understand that an RS will destroy the company as well as the shareholders at this point. He needs financing, not a destructive game of smoke-and-mirrors.
They need eleventy billion dollars before they need to focus more on their 'comma usage' I think?
I don't get it with the Mako-argument...
It's not an excuse for not making your business sound, with solid fundamentals to support your activities.
People talk all sorts of trash about all sorts of companies constantly, yet we don't see it utterly destroy most sound companies. Why?
Fundamentals.
Cash to remain a 'going concern' is just that.
W/O it, there's instability and in our case, absurd volatility.
IF the lawsuit would've resulted in IPIX being sued or dealing with a massively catastrophic settlement, that would've been something completely different.
Now the concern is shifted to the Power of the Buyer.
Do we have leverage going into conversations with prospective partners?
Not really. We have IP, but there are now other options for buyers within the market, thanks to the insane elasticity of IPIX's timeline for development.
I'm not a Bear either. I've been optimistic for years, and hold a pretty significant position... but got in after the high in 2015.
Would I like to see things turn around? Hell yes.
Do I have confidence in Leo to make it happen?
That's my biggest concern.
...which takes me back to my initial concern of:
Why the hell didn't these guys capitalize this thing when they had the chance?
Priority #1 with a new business. Capitalize it so you can conduct 'normal business operations'.
Was the fact that clinical trials aren't free, somehow a surprise to management?
There IS money out there...
Not quite understanding why Leo can't for some reason, tap into it to run trials and develop the company?
Novo Holdings' antibiotic resistance fund backs 3 biotechs
by Nick Paul Taylor | Jan 21, 2019 7:41am
Antibiotic-resistant bacteria
REPAIR reviewed more than 100 “high-quality proposals” last year and is lining up new investments.
Novo Holdings’ REPAIR Impact Fund has revealed investments in three antibiotic resistance startups. The investments funneled around $16 million (€14 million) of the fund’s $165 million budget into the startups to support research into antibiotics and prophylactic vaccines.
Novo, the holding company for Novo Nordisk, created the impact fund almost 12 months ago to help biotechs take drugs and vaccines against resistant microorganisms through discovery and early-stage development. The life science investment group gave the fund a total budget of $165 million and a brief to back about 20 projects in the U.S. and Europe over the next three to five years.
The fund unveiled its first investment, a CHF 6.8 million stake in Polyphor, in September but then went quiet for the rest of 2018. Now, REPAIR has revealed three other investments it made in the last few months of the year.
Two of the investments involved European biotechs. Danish startup Minervax, an existing part of the Novo Seeds portfolio, received €3.6 million from the REPAIR fund to support its work on a vaccine to protect babies from Group B streptococci, a type of bacteria responsible for around half of the life-threatening infections suffered by newborns. The vaccine is in the clinic.
REPAIR also committed €1.5 million to Procarta Biosystems, a British biotech that is developing oligonucleotide-based antimicrobials. Procarta’s oligonucleotides are designed to bind to transcription factors and thereby prevent the expression of genes essential to the survival and pathogenicity of the bacteria. The startup has a treatment for complex urinary tract and intra-abdominal infections in preclinical.
The third, and largest, investment involved Massachusetts-based Entasis Therapeutics. REPAIR put $10 million into the biotech’s $75 million Nasdaq IPO last year, helping it raise the money it needs to take its treatment for multidrug-resistant Acinetobacter infections through a phase 3 trial.
While the Entasis investment involves a late-phase program, the other two deals are more indicative of where REPAIR thinks its money is most needed.
“We back companies we believe can change the future of antibiotic resistance. Despite growing recognition of this global threat, there is an early-stage funding gap for new treatments, specifically from lead optimization up to phase 1 data,” Aleks Engel, director of REPAIR, said in a statement.
Engel said REPAIR reviewed more than 100 “high-quality proposals” last year. This process led to the three newly unveiled investments, plus the earlier deal with Polyphor, and has left the fund with a pipeline of opportunities it plans to pursue this year.
To aid this process, the REPAIR fund has appointed antimicrobial R&D specialist John Rex, formerly of AstraZeneca, as chairman of its scientific selection board. The board helps the fund to decide which companies to back.
There's a difference between actual reality and FUD.
The picture painted with respect to the company fundamentals is a real one.
No COH. Minimal lending/borrowing options (or else they'd use other less-predatory/dilutive ones)
NO revenue (yes, I realize this is 'pre-revenue-biotech') in the form of a partnership.
NO means to progress trials
I do question the sanity of management.
They articulate a 'plan for progress', but there's literally zero cash.
This is akin to driving your car with the gas light on, yet you're in the middle of a desert. No gas for hundreds/thousands of miles. Yet you keep talking about getting into the new house you're building on the other side. How about a contingency plan in case you run out of gas? (because all indications are pointing to this being a likelihood)
Mack, can you explain how IPIX will run trials with zero COH and zero access to cash?
If the MFO backs out of their arrangement, then they literally have zero options.
So someone please explain to me how this works, because even with an MBA, I'm not understanding it.
Elaborate Plz...
Agreed. I'm sort of feeling like the trial organization and execution is a byproduct of general lack of sufficient economic backing. (which isn't an explanation of strange reporting or analysis)
I also am not quite understanding why targeting a specific partner who's articulated an interest, with specific interim desired-data, hasn't been happening.
SO much going on that makes zero sense to me related to how they're 'running this as a business'.
If I claim something, it will be in writing and I will support it with empirical data, if not bound by a contract.
I'm not into ridiculous inferences.
...are you forgetting he's making almost $500k a year with zero personal liability?
Actually this isn't exactly completely accurate...
This would be the end of IPIX.
This is the entire pipeline: B & K.
If you sell everything for pennies on the dollar, when Leo's lowest current offer is indicating that B-OM is worth $150M/yr, then I'm not sure this would be even part of his consideration set.
Keep in mind that P53 modulation is sort of the 'holy grail' for cancer treatments. Leo's view of K is likely vastly different than what you're articulating here.
I feel based on the info they've provided to-date and the B-OM market, that B-OM alone should be worth a sum greater than $1B in a license-structured deal.
IMHO.
Just going by these posted mentions:
http://www.ipharminc.com/new-blog/2017/12/27/kevetrins-effect-on-the-p53-signaling-pathway-in-a-broader-scientific-context
'Preliminary results show modulation of the p53 protein, as well the activated form of the protein, phospho-p53, in response to the administration of Kevetrin. Pathways analyses also point to concomitant cell cycle modulation at the level of gene expression. Importantly, these data directly support Kevetrin's ability, in ovarian cancer patient tumors, to affect p53 and associated molecular pathways -- the central gene signaling network involved in regulating cell growth and the cell cycle, helping to prevent cancer. '
I don't think they can say this in any sort of PR w/o coming under significant legal pressure (liability) for misrepresentation?
further: https://static1.squarespace.com/static/5715352e20c647639137f992/t/58e38969ff7c50817178cbe0/1491306863482/AACR+2017+complete+poster++FINAL+2017MAR30.pdf
Results summary:
•Kevetrin induced apoptosis in wild type p53, mutant p53 and
partially deleted p53 ovarian cancer cell lines as assayed by
cleavage of PARP.
•p53 and p21 increased protein levels were seen in A2780 cells (p53
wild type) after 24 to 48 hr exposure to Kevetrin. Depletion of p53
by SiRNA reduced the p21 expression as assayed by FACS.
•Kevetrin downregulated oncogenic mutant p53 in OVCAR-3 and
OV-90 (p53 mutant)
•Increase in p21 mRNA in response to Kevetrin was observed in all
OC cell lines.
•No significant changes were observed in p53 mRNA.
•In xenograft models, Kevetrin inhibited A2780 tumor growth, and
increased SKOV-3 animal survival.
•Transcriptomic analyses demonstrated that Kevetrin modulates p53
signaling pathways and induces apoptosis and cell cycle arrest in
ovarian cancer cell lines as well as xenograft tumors as shown by
RNAseq data. KEGG pathway analysis was used for these studies.
• Altered expression of miRNA-27a, miRNA-1274b, miRNA-25
(known to be dysregulated in ovarian cancer) in a time-dependent
manner in OVCAR-3 cells provides possible biomarkers for
Kevetrin response.
•In tumors where p53 is partially deleted (SKOV-3), Kevetrin
modulates p53 pathways and induces apoptosis. Further detailed
mechanism studies are ongoing.
Certainly not trying to take George's copy/paste approach here and beating the IPIX-drum over the deafening noise of burning corporate fundamentals (not to mention a broad history of missed deadlines, a P2 failure, gibberish PR's etc), but there seems to be supporting data to the effect of them being onto something with K.
I think ultimately BP will determine what our products are worth based on them putting their dollars on the table. Things are only worth what the market is willing to pay.
I'm also certainly not blind to the risk in BioTech. Lord knows I'm stuck holding a pretty significant bag here, and have ridden a ridiculously large position all the way down to where we currently sit.
I would like to see things change, but not purely for selfish reasons. Bringing B-OM to market will address a significant unmet need and alleviate suffering. That's the best we could hope for. Not to mention funding IPIX and getting us off the floor where we're currently laying... bloody and battered.
Kevetrin possibly in concert with other treatment tandem-options, could possibly do wonders for addressing one of the more serious health-concerns we currently face as a species.
I don't think we're getting a 'New Year's deal-message' because they're not 'there yet'. Maybe end of Jan, or a week or two sooner perhaps.
...because SEC filings are a bunch of nonsense and fake news... ok.
It means P53 modulation was demonstrated. It's effective.
Hence the partnership interest that was articulated if they can reformulate to Pill form.
Apparently, people have a hard time reading for comprehension on this board... They know who they are.
Read what's written to get the data you need. Don't listen to what others interpretations of the facts are.
Maybe re-familiarize yourself with the NASDAQ uplisting requirements, along with AMEX.
Then do the math concerning shares outstanding, and the deal-ballpark concerning the existing TS.
Without knowing the actual structure of what's on the table, we can't get precise, but you can estimate.
I think if you plug in realistic numbers based on the valuation of product over time, given the estimated life of the patent, you'll reach a number that should put us in the vicinity of being able to meet uplisting criteria for the NASDAQ.
https://listingcenter.nasdaq.com/assets/initialguide.pdf
LEO is the wildcard here. He's going to be driving to what could appear to be an unrealistic sum, based on a likely emotional attachment to IPIX and the current state of progress across 2 indications (with the TS having been announced to include IBD interest as well). The numbers and applications are actually on his side, however.
The emotional sunk-cost associated with this could be the catalyst to whether something moves or not. They're shopping now. They feel they can do better than what's currently on the table.
Cross your fingers.
You appear to be target-fixated on the SP (like most folks here on this board)...
...and missing the forest. The IP is what has the value.
BP will take one look at the BOD of IPIX and not want to have anything to do with them developing literally anything most likely.
I've already heard this from multiple contacts within both financial industries as well as competitive BioTechs.
Where the value lies, is in the IP. How long the patent life extends, and what sort of market exclusivity exists. Ease of use along with scope of applications is critical as well (for determining market-size for application).
An outright sale or license is where things should likely head, given what's on the table.
I can't imagine anyone wanting these guys to further develop anything they're sitting on, nor do they have the resources to do so.
SP has literally nothing to do with any of this. It's not a bargaining-tool.
If IPIX burns to the ground and we lose it all, the IP still exists and has monetary value.
Think about that.
LR- Call me crazy but....
I feel like this is so amazingly, ridiculously important that it can't be overstated:
You might want to show your work, if you’re going to make otherwise unfounded claims related to SP of this nature.
We don’t know terms of a deal.
We don’t know timeline.
But we do know Shares Outstanding.
...and we know approx dilution.
We can plug numbers in from there once we have them.
Given basics related to B-OM we’ve heard (somewhere, i can’t remember where) that domestic market is somewhere around $100M/yr + $200M global.
That’s a place to start.
None of that gets us anywhere near to the .30-.50SP you’re claiming.
So please show your work.
In reality, the SP is actually more connected to the true fundamentals than anything else.
COH is going to expire after another month or two at current burn rate.
Value is in IP, but they can't capitalize it without licensing it or getting it approved.
The structure of any sort of pending deal and the adjustments to the balance sheet that an upfront payment will make is what will move the SP instantly.
Ideally we see an announcement of a deal late Jan (or earlier), followed by the update of the balance sheet, and hopefully additions to the BOD to make these guys look a little more diverse.
THEN we see a strategy outlining the progression of the P3 for B-OM, possibly IBD etc. Great!
THEN with some better public retail-support of the SP, we see them in a position to uplist, where they're available for commercial investing.
THEN things start to look slightly better.
.... please see post #238138
I don't believe this to be the case actually...
They still have options, but the concern is Leo's seeming inability to comprehend time (in addition to being able to close a deal of any sort).
If they license a product for a specific indication, that's worth money. That's possibly one of the faster means of realizing a revenue stream (and what I'd do to fund the progression of other considerations on the table).
If they partner and then take on cash upfront and write in royalty payments, depending on how quickly they can complete the P3 and get approval to take a product to market, there's an opportunity there as well to salvage.
Time is of the essence here. They just burned up literally an entire year with zero results of the public-facing-partnership-variety. That's a problem. The SP reflects this. Market-confidence reflects this.
No RS required really. IF they can get SP up (organically through a partnership/license) then they'll be ok.
There was talk of doing this organically with 'clinics' and a direct-marketing opportunity they'd identified once they'd got to P3. I don't understand the intricacies of the setup, but I see it as being a stretch. They're also not allowing for their burn-rate. I don't understand their in-house strategy whatsoever, and it doesn't seem to account for things like time and overhead. (strange, right?)
They're looking at further dilution just to get there with the MFO. Once they hit a certain point (assuming they're able to), then Aspire could come back into the picture (not sure how that was left)...
RS is the absolute LAST thing we want to see. Period (aside from the office burning to the ground of course).
IPIX isn't going anywhere without either partnership or a licensing deal for an existing indication.
Leo thinks he can go this alone (yes, I know this for a fact). What he's not thinking about is the burn-rate over time and the CDB factors that have driven him to the place we're currently sitting.
...my only concern with the TS is:
They're not required to disclose the status (failure) based on wording. So if the TS is no longer active (which I'm suspect-of), then Leo's planning to go this alone.
Super interesting.
Also a great comment at the bottom as well, concerning oversight and qualification of staff/management:
Agreed.... and it would seem to likely be effective for Thrush and other oral concerns as well.
More links, in case you can't locate the 10Q on your own
https://www.etrade.wallst.com/v1/news/marketnews/marketnews.asp?ChallengeUrl=https://idp.etrade.com/idp/SSO.saml2&reinitiate-handshake=0&AuthnContext=authenticated&env=PRD&docKey=1-SN20181108020525-6CQGQAAIA8V2FA3Q99H04PGKCD&DMSourceID=DJNF&Source=PMZN&DisplayName=GlobeNewswire&docDate=2018-11-08%2022%3A00%3A00&headline=Innovation%20Pharmaceuticals%20Provides%20Corporate%20Update%20Highlighting%20Business%20Development%20and%20Clinical%20Pipeline%20Priorities
PR: http://www.ipharminc.com/press-release/2018/11/8/innovation-pharmaceuticals-provides-corporate-update-highlighting-business-development-and-clinical-pipeline-priorities
SEC: https://www.sec.gov/Archives/edgar/data/1355250/000147793218005343/0001477932-18-005343-index.htm
SA: https://seekingalpha.com/filing/4231642
...if I click on it, it takes me to the posted 10Q.
Not sure what the problem is?
ah yes, makes sense.
You're correct. Thanks for clarifying.
It was in reference to this... at the end of the update:
I thought it was relevant in light of the FDA 'refusing to file the application'....
'The setback likely leaves Alkermes back where it was at the beginning of the regulatory process, when the FDA initially refused to file the application and then did an about face and opened the door to a review. The company has another trial underway, but now may well be looking at a requirement to mount new, expensive and lengthy clinical trials that would likely take at least 3 years to complete'