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Assuming Prurisol at least matches Otezla in results but with a better safety profile, what would be a realistic value on an outright sale of that asset at this stage of development (Ph3 ready)?
Hmm. Would their plan to use B in a Sachet formulation change the need for that in any way? Any sort of bridging study required before they'd move to Phase 3? I could see them waiting until after that to meet with the FDA if so.
Breakthrough Therapy Designation - given that the last update was May 9th to tell us that the data analysis was complete, do folks think we should allow 60 days from May 9th to get a response from the FDA on BTD? That would put us into July for a decision if so (about 2.5 weeks from now at the earliest)...
I don't assume they'd sell all their shares necessarily but based on the business model of these shops I'd have to imagine they prefer to lock in concrete gains sooner than later to mitigate risk. Let's assume the share price goes to $1 from here (at a minimum) on good news. For the shares purchased at 25 cents, that would be an incredible gain in less than a year and much more than they would typically realize on one of their investments. For that type of company, it would be a no-brainer to liquidate a majority of their holdings at that point.
Trust me, I hope I am wrong and that they hold out for much more like the majority of us here plan to but it is unlikely for that type of firm.
Let's hope that when they unload on presumably good news that it doesn't kill the momentum upwards.
Thanks, June should certainly be interesting...
For those interested:
2017: Longest gap between PRs was 25 days
2018: Longest gap between PRs so far is 35 days (February to March)
We’re currently at 22 days since last PR.
A deal should not be struck until they know if B-OM will be awarded BTD
Agreed. IMO he is subtly indicating that in the PR with this line:
“The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise.”
To soon for another insightful interview with the IPIX team?
“Given the notable interest from global and specialty pharmaceutical companies that we have received following recent Brilacidin-OM data releases, we continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward....The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise.”
What is the impression of this line? Is he suggesting they choose between a deal that covers B-OM or one that covers all of B? Or am I reading too much into this...
I assume they will at some point. However, where will the money come from? If a partner does not fully fund the trial, what are our options outside of Aspire? We can't continue to fund operations this way.
In the absence of complete phase 3 B-OM funding from a partner, what other options are there to raise the needed capital? Continuing with Aspire would be catastrophic to shareholder value at this point.
The benefit of this PR is that at least now we know they are done with analyzing the data and partners are no longer waiting on any additional data points.
At this point, the negotiations should really proceed in earnest as it's all on the table (minus BTD, but that could be worked into milestone payments etc). As frustrating as it would be to sell the B-OM indication short on a first partnership deal, there is a duty to shareholders to not destroy shareholder value if it's not necessary. I hope they are weighing the full consequences to shareholder value for continuing to bide their time on this (and further dilute and erode share price) rather than take a sure but less-desirable deal now.
Today's PR is both frustrating and hopeful at the same time, ugh. At a certain point the company really needs to become less concerned with waiting on the "perfect" deal for IPIX and take the best of what's on the table. The steady and quickening share price erosion/dilution will negate any eventual value gained when and if a partner is announced if this continues for much longer and if the full Phase 3 trial costs are not covered by a partner, then we are most certainly headed for a RS to cover the rest. In all seriousness, in the absence of complete funding from a partner, what other option would there be?
Assuming we get a deal for B-OM (with an upfront payment of 5-15 million), does it seem likely we would still need a reverse split to raise enough money for a P3 B-OM trial? Or should/would the costs of the P3 be covered by the partner? We are headed below 25 cents before the end of June if nothing changes. Even with a partner announced, not sure how much we can count on the share price appreciating enough to secure the necessary funds.
10-Q soon, followed by the ASM. Should be an interesting month!
10-Q out next week, will be interesting to see their current cash position
We could certainly use another "state of the union" type of update at this point. Looking forward to the next 10-Q in early May so we can at least see what the current cash position is.
Some additional things that would be nice to know:
Have we had our end of Phase 2 B-OM meeting with the FDA? If not, has it been scheduled? If not, why and what is the process required to get there?
Are the Prurisol trial results still blinded? If so, what needs to happen for them to unblind?
What is our current cash position?
Without a partner (at the moment), how do we plan to raise funds to move the drugs forward?
Where are we at with K oral formulation?
How many companies under CDAs are still actively participating in crafting partnership terms and moving negotiations forward?
"As I will indicate in tomorrow’s invited talk, Lightwave Logic’s advancement in polymer-based PICs: PICs are Here to Stay – They are a game changer for the photonics community.”"
Gotta love that...
For any curious, Innovation’s fiscal year-end is June 30th.
http://www.ipharminc.com/investor-faq/
Anyone read about this? Sounds related, not quite sure what to make of it:
https://newatlas.com/optoelectronics-computer-chips-ayar-labs/54109/
https://ayarlabs.com/product
Anyone know if we'll be able to see the slide deck for Lebby's presentation?
"The Company is currently focused on completing the Clinical Study Report for its Phase 2 clinical trial (see NCT02324335) evaluating Brilacidin’s ability to safely prevent and attenuate SOM in HNC patients receiving chemoradiation and compiling a Briefing Package for discussion with the FDA. "
Think I missed something here - what conference was this?
TIA
I find this intriguing - "as necessary":
As we move forward through 2018, we expect to continue building our world-class design team for both polymer materials and integrated photonics technology platform to further optimize our P2IC™ platform. With the now consolidated facility in Englewood, Colorado, we will complete our clean-room and laboratories so that we can keep key technologies and processes internal to the Company. We will package our modulators for customer evaluation, and will continue to design our polymers for improved data rates and lower power operation. We will engage with customers to fine tune our technology to meet customer expectations, and we will scale our technology to provide cost effective technological solutions for the fiber communications market segments. We will partner with other companies as necessary, e.g. our packaging partner in 2017/18 is allowing us to move quickly towards customer prototypes.
It gives the impression (at least to me) that they are firmly in the driver's seat with this sought-after technology and will dictate any terms with potential partners/suitors without giving up any power/control...
Ah, there it is...
There should only be a few weeks left until they are fully transitioned into the CO office location. I'd imagine we'll get an update at that point once the move is completed.
So much potential here given the UP trial results from 2017 - would love to hear more about their planned next steps to tackle the IBD market...
Thanks runninggirl2016 for the reminder!
Bertolino Sept. 2017........
“What we and potential partners are extremely interested in is learning via tumor biopsies if Kevetrin is reaching its target and modulating pathways within the tumor that can deliver a clinically meaningful benefit; this would be a significant development in the p53/oncology dynamic,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “If that is indeed the case in any number of patients, we will have compelling evidence to move forward expeditiously. A next step would be to complete development of an oral formulation of Kevetrin, which is the preferred delivery method of patients and facilitates the potential for multiple daily doses.”
Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications — Oral Mucositis, Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases
Brilacidin
http://www.ipharminc.com/press-release/2018/1/29/innovation-pharmaceuticals-brilacidin-franchise-anchored-in-three-clinical-indications-oral-mucositis-inflammatory-bowel-disease-and-serious-skin-infections-expands-into-dermatologic-diseases
BEVERLY, MA – January 29, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provides a business development update:
· The Confidential Disclosure Agreement (CDA) count toward partnering with global and specialty pharmaceutical companies interested in the Company’s first-in-class drug candidates is nearing 20, with additional Agreements in review. Successfully securing partnerships would afford the Company access to immediate and potentially recurring sources of non-dilutive capital, including upfront fees, milestone-based payments and tiered royalties;
· A leading international drug manufacturer has been engaged with to bulk produce commercial-quality Brilacidin, aimed at lowering patient drug cost and anticipating future drug needs in preparation for expedient market introduction. This critical step also proactively facilitates future patient and insurance reimbursement adoption through favorable cost savings;
· After a recent successful Phase 2 trial in Oral Mucositis (OM), the Company believes that it is the clear global leader in this area as it develops an easy-to-administer oral rinse medicine for the prevention of severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation—analysts estimate this market could reach $1 billion in coming years.
Brilacidin—Dermatology Formulation Development
Brilacidin has successfully completed Phase 2 trials in Oral Mucositis (OM), Inflammatory Bowel Disease (IBD) and Acute Bacterial Skin and Structure Infection (ABSSSI). A drug with broad platform potential (pdf), Brilacidin’s innate properties and modes of action, as well as additional pre-clinical work, support the drug’s potential for topical application in dermatology, including: Atopic Dermatitis, Acne, and Hidradenitis Suppurativa. All are areas of large unmet need and comprise highly lucrative markets.
To further these efforts, the Company is in negotiations with a leading drug formulator to develop topical formulation(s) of Brilacidin for these three dermatology indications, starting in 1H2018. The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets. The formulator brings an impressive track record of developing products that have earned billions of dollars for global pharmaceutical companies.
For a discussion on Brilacidin’s potential as a topical agent in dermatology, please read more at the following link:
· “Brilacidin’s Potential Application in Dermatology”
For more on Brilacidin, learn more here:
· http://www.ipharminc.com/brilacidin-1/
Maybe I'm not remembering correctly but wasn't that supposed to be conducted at U of Bologna in Italy and then the university lost funding it needed to conduct the study? I seem to remember this being addressed by mgmt in a communication (could have been a 10-Q as well) at some point
"The unmet medical need in OM is tremendous and we look forward to advancing Brilacidin-OM toward possible market approval, which would help improve the lives of so many cancer patients.” - Dr B.
Probably over thinking this (and admittedly naive to requirements) but any chance this could mean they are angling toward accelerated/conditional approval, rolling review, etc? Or is that out of the question and the simplest interpretation, that they will now move to a P3 and then hopefully garner FDA approval, the only thing implied here?
Next up, Kevetrin interim/preliminary results???
Fantastic, thanks Proto
Seeing as the move to the new, upgraded facility will not be complete until March 2018 I have to wonder if the completion of the internal test results on the 50G packaged prototype devices are also unable to finish until that time. If that's the case I won't expect an initial spec sheet until late 2Q at the earliest.
Secondary Endpoints from B-OM trial: Have to imagine they will have these ready for the January 2018 Biotech Showcase presentation. Does that seem too soon?
When is the next presentation/event?
TIA!
Looks like they are in the midst of their Phase 1 trials:
http://criticaloutcome.com/coti-2-and-pipeline/pipeline/
Mucosal healing: An objective measure of disease activity? (November 21, 2017 author Francis A. Farraye, MD, MSc, professor of medicine at Boston University School of Medicine.)
The absence of inflammatory and ulcerative lesions in all segments of the colon, also known as mucosal healing, should be the end goal in treating patients with ulcerative colitis according to an editorial in the journal Gastrointestinal Endoscopy. The authors believe the analysis in the study by Flores and colleagues, Impact of Mucosal Inflammation on Risk of Colorectal Neoplasia in Patients with Ulcerative Colitis: A Systematic Review and Meta-Analysis, reaffirms the suspicion that ongoing colonic inflammation not only increases the risk of abnormal growth of colorectal tissue (pre-cancer and/or cancer), but also may affect guidelines for surveillance colonoscopies.
"There are several reasons to target mucosal healing in patients with ulcerative colitis, reducing cancer risk being one of them. If we are truly aiming for mucosal healing, this may mean more aggressive medical therapy early in the treatment course even if histologic activity is not necessarily reflected in patients' symptoms," explained corresponding author Francis A. Farraye, MD, MSc, professor of medicine at Boston University School of Medicine.
The authors said the pivotal role played by mucosal healing in driving favorable outcomes in ulcerative colitis is acknowledged, but whether this bar should unequivocally be set at histologic healing and if so, at what level, remains to be established. "Arguably, the first step is to better define histologic remission and healing In addition, the use of validated endoscopic scoring systems that provide objectivity, uniformity and standardization in reporting mucosal appearances, augmenting clinical decision making and ultimately affecting appropriate treatment targets and desirable patient outcomes," said Farraye, clinical director in the section of gastroenterology at Boston Medical Center.
https://medicalxpress.com/news/2017-11-mucosal-disease.html
Thanks (and to Blue Fin as well)
This must be where we are at (from that PR):
"...Remaining safety studies will be completed in the second half of this year."
Oral Kevetrin - Anyone recall off the top of their head when the company last addressed this?