INmune Bio Inc. Completes Enrollment for Phase 2 Trial in Early Alzheimer’s Disease
Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and...
INKmune™ Demonstrates Excellent Safety and Increased NK-Cell Activity in First Dosing Cohort
TW's Take: excellent safety and initial efficacy. Later cohorts will determine just how efficacious this product will become.
BOCA RATON, Fla., Sept. 26, 2024 (GLOBE...
INmune Bio Announces Results of Additional Blinded Interim Analysis of Phase 2 Alzheimer’s Disease...
BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today...
INmune Bio Announces $13.0 Million Registered Direct Offering
TW's Take: puts roughly two additional Q's of cash on the balance sheet post expected data early next year.
Boca Raton, Florida, Sept. 13, 2024...
INmune Bio Inc. Announces New Phase 1 Study Data Demonstrating Dose-Dependent Effect of XPro™...
AAIC Poster Presentation Highlights XPro's™ Significant Effects on a Wide Range of Synaptic Proteins and Pathways
BOCA RATON, Fla., July 29, 2024 (GLOBE NEWSWIRE) --...
INmune Bio Inc. Publishes Novel Biology on Natural Killer Cancer Immunotherapy INKmune™ in the...
Publication of detailed analysis on INKmune biology compared to cytokine stimulated cells demonstrates important anti-tumor memory like NK cell characteristics
BOCA RATON, Fla., July 23,...
Not Totally Blind…INmune Provides A Clue
This week I'm starting the newsletter with a discussion on INmune Bio (INMB). There are two reasons for this. Firstly, the company put out...
INmune Bio, Inc. Completes Blinded Interim Analysis of Phase II Alzheimer’s Disease Trial
TW's Take: this is a very positive update confirming the endpoint's effectiveness and the trial design. We are nearing the end of enrollment, with...
INmune Bio Inc. Provides Update on Two Patients from the Phase 1b Alzheimer’s Disease...
TW's Take: mind-blowing results from an admittedly small "n". I am not aware of any other clinical trial in AD that has had one...
INmune Bio Inc. Completes First Cohort and Initiates Second Cohort of Phase 1/2 Study...
TW's Take: enrollment is going great and we should see some clinical data over the summer. This program has the chance to catch the...
Financing…Quality Matters
Until they mature and hit profitability, small-cap growth companies rely on financings to fund their operations. Sometimes that money is easy to come by...
INmune Bio Inc. Announces $9.7 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
TW's Take: this financing is a high-quality deal with only one investor who was limited to $9.7M to stay below 5% of the company....
INmune Bio Inc. Announces 24-Month Stability Validation of XPro™ for Phase III Readiness and...
TW's Take: INmune is getting their ducks in a row for a large phase 3 trial, which we hope to see starting near the...
INmune Bio Inc. Raises Approximately $4.8 Million in Gross Proceeds Through Registered Direct Offering...
TW's Take: this provides the capital to get the company through top-line AD data. I suspect the shorts are going to be very worried...
INmune Bio Inc. Presents Data on INB03’s Role as an Immune Check Point Modulator...
TW's Take: outstanding data sets the stage for potential partnering of INB03.
Novel Immunotherapy Approach Targets Soluble Tumor Necrosis Factor to Overcome Resistance and...
INmune Bio CSO and Co-Founder Mark Lowdell, Ph.D. Receives The ISCT Career Achievement Award...
TW's Take: Quite an honor for Mark. His “goal of creating a scalable cancer immunotherapy that can be easily delivered to a large number...
INmune Bio Reports Significant EEG Improvement in Alzheimer’s Patients Treated with XPro™
TW's Take: more solid evidence of the clinical benefits derived from XPro. Really looking forward to seeing phase 2 results around year-end, which could...
INmune Bio to Participate in Baird’s Biotech Discovery Series Webcast on February 13, 2024
TW's Take: we are expecting increased institutional interest in INmune and this conference could help highlight a great program that, with the FDA hold...
INmune Bio Announces FDA Removal of Clinical Hold for Alzheimer’s Disease Program
TW's Take: Finally! This doesn't change the phase 2 timeline but sets the stage for phase 3 and also opens the door for more...
INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune™ in...
TW's Take: great to see this exciting program entering the clinic. 2024 is a catalyst-filled year for INMB.
Boca Raton, Florida, Jan. 02, 2024 (GLOBE...
INmune Bio Provides Update Regarding Global Alzheimer’s Phase II Clinical Trial and Clinical Hold...
TW's Take: the FDA continues to confound and frustrate INmune as their trial moves forward expeditiously outside the US. Perceptual negative but no real...
INmune Bio Inc. Demonstrates that INB03 Enhances the Uptake of Trastuzumab Deruxtecan in HER2+...
TW's Take: more exciting data that should perk interest in potential partnering of INB03. Pre-clinical but clinically relevant and potentially very meaningful for patients.
...
INmune Bio Receives EMA’s Authorization in France and Spain for Phase II Clinical Trial...
TW's Take: INMB is accelerating progress towards full enrollment. Results will be coming in late 2024, which is the key catalyst investors have been...
INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer’s Disease in...
TW's Take: more jurisdictions approving the AD trial not only bodes well for enrollment but sets the company up for a well received phase...
INmune Bio Inc. Patent Claims Covering INB16 Cell Line and INKmune™ Therapeutic Composition given...
TW's Take: the INKmune program is getting up to speed with patient enrollment now meeting or beating expectations. Patentability is key for the long-term...
INmune Bio Inc. Presents Preclinical Data at SITC 2023 Showing INB03 is an Innate...
TW's Take: more pre-clinical support for INB03. This program is a potential partnering opportunity or will be taken into phase 2 once the AD...
Testing Support…(Not Likely to Hold in TW’s Opinion)
Last week, when discussing supply and demand, I wrote that "the landscape is tilted towards lower stock prices." That was certainly the case the...
INmune Bio Inc. Presents New Biomarker and Feasibility Data from Phase 1b Study Supporting...
TW's Take: this is clear evidence that INmune is on the right path to an effective treatment for Alzheimer's. Improvement in the pathologies at...
INmune Bio Inc. Announces Approval of Clinical Trial Application by the U.K. Medicines and...
TW's Take: good news as this approval should not only accelerate enrollment but is a positive sign as we await expected EU and FDA...
INmune Bio Inc. to Deliver Keynote Talk at 5th World Aging and Rejuvenation Conference.
TW's Take: as this keynote address demonstrates, INmune is the leader in using biomarkers of inflammation to demonstrate cognitive decline. Removing soluble TNF with...
INmune Bio Inc. Announces Novel MRI Biomarker Data Demonstrating Improvement in Gray Matter in...
TW's Take: very positive data that should open some eyes at AAIC next week. INmune continues to lead the field in developing new biomarkers...
INmune Bio Inc. Announces Data Presented at the 16th European Meeting on Glial Cells...
TW's Take: more highly supportive evidence of the beneficial effects of neutralizing soluble TNF. Adds to the growing body of evidence supporting XPro.
Neutralizing soluble...
The Spotlight Turns to INmune Bio…
When I initially got involved with INmune Bio (INMB), one of the first pieces I published on the company was titled, "INmune’s Efforts in...
INmune Bio Inc.’s Chief Scientific Officer, Mark Lowdell, Ph.D. to Present Plenary Talk at...
TW's Take: INKmune continues to have outstanding data that makes it potentially the market leader in NK cell therapies. The data being presented looks...
XPro1595 Improves Outcomes in a Mouse Model of TBI-induced Alzheimer’s Disease
TW's Take: this trial demonstrates that inhibiting TNF arrests the development of amyloid pathology in TBI patients, but also gives hope that this works...
INmune Bio, Inc. to Present Preclinical Data at the 2023 AACR Annual Meeting Showing...
TW's Take: INB03 has been shown to have a very positive impact in reducing the tumor micro-environment, which enables other therapeutics to perform better....
INmune Bio, Inc. Announces Submission of Investigational New Drug (IND) Application for INKmune™ to...
TW's Take: good progress on what looks like a very promising treatment in solid tumors. Nice to see the latest patient in the AML...
INmune Bio, Inc. Receives Approximately $6.4 Million in Research and Development Rebates from Australia...
TW's Take: INmune is a very good steward of investor capital, as this demonstrates. This adds an additional quarter of funding to INMB in...
INmune Bio, Inc. Announces Pre-Clinical Data That Support a Pioneering Approach to Treating Duchenne...
TW's Take: exciting news as the "wonder drug" that is XPro demonstrates exciting data in yet another major, untreated disease.
Boca Raton, Florida, Jan. 25,...
INmune Bio, Inc. Data at ASH Highlight Innovative Natural Killer Cell Therapeutic Platform Showing...
TW's Take: positive news but, until enrollment picks up or the solid-tumor trial in the US starts, this program is not going to get...
INmune Bio, Inc. Reports Combination Therapy with INB03™ Overcomes Resistance to Trastuzumab-Deruxtecan in MUC4...
TW's Take: excellent pre-clinical data sets the stage for the long-term success of INB-03. Another reason that, once the FDA hold is removed, this...
INmune Bio, Inc. Focused on Novel Clinical Trial Designs to Advance Next Generation of...
TW's Take: this PR sums up quite succinctly what makes INmune different from other companies targeting Alzheimer's Disease. Once the FDA approves the trial...
INmune Bio, Inc. Receives Health Canada “No Objection Letter” to Commence Clinical Trial of...
TW's Take: good progress but really need to get the FDA's approval to dramatically move the needle on enrollment. Frustrating but will come.
BOCA RATON,...
INmune Bio, Inc. Announces Positive Solid Tumor Efficacy Data in Multiple Cancer Cell Lines...
TW's Take: very positive news, albeit pre-clinical. This program is set to hit US trials in 2023, which would be a big deal for...
USPTO Issues Patent Covering Use of XPro™ for Treatment of CNS Diseases
TW's Take: this completely locks up CNS for any DN-TNF therapies for over 10 years (with a possible extension). Very good news for INmune.
Boca...
Going Downhill
This past weekend I spent mountain biking in Downieville. Our group gets shuttled up to the top of the mountain and then careen down...
INmune Bio, Inc. Presents Data on Combination Therapy with INB03™ on Overcoming Resistance to...
TW's Take: INB03's ability to change the tumor-micro-environment enables a whole new set of patients to take Herceptin and other drugs. Potentially game-changing for...
High Degree of Confidence
This week I'm writing my newsletter on Thursday as I'm heading out to California this afternoon. The upcoming weekend will be spent in Downieville,...
June Gloom
In San Diego, this time of year the mornings can bring coastal fog. Referred to as "June Gloom", it usually lingers until late in...
INMB: Making Sense of The FDA Clinical Hold
Yesterday INmune Bio (INMB) announced that their phase 2 Alzheimer's trial, which has already commenced in Australia, was being placed on clinical hold by...
INmune Bio, Inc. to Provide Additional Manufacturing Information to FDA as Part of IND...
TW's Take: disappointing news as this puts a delay on the trial that will likely take somewhere between 6 to 9 months. This will...
CEO Knows Best
The saying about insider stock transactions goes like this, "there are many reasons for insiders to sell but only one reason for them to...
INmune Bio Looks to Change The CNS Landscape
Dan Carlson, TW Research (Dan)
RJ and CJ, thanks for joining us today. I’d like to start out by saying I find it very interesting...
INmune Bio, Inc. Presents Data Demonstrating XPro™ Promotes Remyelination in Gray Matter at 3rd...
TW's Take: this is excellent data that demonstrates remyelination in gray matter on top of the white matter data previously presented by IMEKA. XPro...
INmune Bio, Inc. Announces First Quarter 2022 Results and Provides Business Update
BOCA RATON, FL., May 05, 2022 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness...
The Rolling Correction Gathers Steam…
Thus endeth the worst month for the stock market since March of 2020. Friday's meltdown took the S&P to -9% for the month. It's...
Does Nkarta’s Positive NK Data Have Any Relation To INmune Bio’s INKmune Program?
~ This article is available for premium subscribers only. Please do not share the information here with non-premium subscribers or with company managements. Thank...
It’s A Process
This past week in Charlottesville, The Boar's Head Women's Open took place. This is an annual tennis tournament featuring 32 professional tennis players, most...
INmune Bio Announces First Patient Dosed in Phase 2 XPro1595 Trial for Treatment of...
TW's Take: exciting news as this trial is now off and running. I expect enrollment will be fairly quick as the trial design is...
INmune Bio, Inc. to Present Preclinical Data on INB03 at the American Association for...
TW's Take: very positive data that demonstrates INB03 could be a potential partner drug for both the herceptin and TKI classes of drugs. Potentially...
INmune Bio, Inc. Highlights INKmune™ Data Featured in NK Cells in Solid Tumors Workshop...
TW's Take: INKmune is proving itself to be the best performing NK therapy in both surviving in the toxic Tumor Micro Environment and demonstrating...
INmune Bio, Inc. Announces Company’s CSO Dr. Mark Lowdell to Co-Host the “NK Cells...
TW's Take: all patients treated with INKmune are doing better but this is just a teaser to the patient case studies that they will...
INmune Bio, Inc. Spotlights Key Findings in Presentations at AD/PD™ 2022
TW's Take: based on surveys conducted at AD/PD it's increasingly clear that inflammation is becoming a leading target for treating Alzheimer's, which positions INmune...
INmune Bio, Inc. Announces Nine Data Presentations at AD/PD™ 2022 – International Conference on...
TW's Take: this is the biggest Alzheimer's conference in Europe. INmune having 9 presentations is very impressive for a small company and really speaks...
Groundhog Day
Another week in the market, another leg down. Some pundits are saying we are now entering a bear market. Those of us who invest...
This Trend is NOT Your Friend
Volodymyr Zelenskyy is a hero. Contrary to what I thought would happen last week, Ukraine is putting up a valiant battle, holding off the...
INmune, a very brief update
~ This article is available for premium subscribers only. Please do not share the information here with non-premium subscribers or with company managements. Thank...
Putin It In Perspective
By the time you read this newsletter, there's a good chance that the Ukraine will be begging for a ceasefire and, basically, surrendering to...
Metamorphosis
What a week in the markets, right? The past five days saw the biggest ever one day loss by a single company, followed shortly...
This Week’s Billboard Headline…Glenn Mattes Stars As Rocky Balboa!
When we had kids I was super excited to watch classic movies with them once they were old enough. Top on my list was...
INmune Bio, Inc. Announces Research Collaboration with Chinese University of Hong Kong to Evaluate...
TW's Take: INKmune is just now beginning to break out of its shell. The world knows very little about this drug, but the results...
An INKmune Update, Catalysts Included…
~ This article is available for premium subscribers only. Please do not share the information here with non-premium subscribers or with company management. Thank...
Happy New Year!!!
Investing in micro-cap stocks with a 3-5 year time horizon, which is my expectation for a holding period every time I enter a position,...
INmune Bio, Inc. Announces Key Breast Cancer Treatment Resistance Data to be Presented at...
TW's Take: the anti-inflammatory INB03 (also called XPro1595 in CNS indications) has broad-scale potential as TNF appears to be the master-cytokine, sparking inflammation that...
Bottom Picking
My constant refrain for most of 2021 has been that I don't like the market but love the stocks in my portfolio. I can...
INmune Bio, Inc. Announces Two Presentations at the 2021 British Society of Immunology Congress...
TW's Take: long-lasting, memory-like NK cells is the holy grail of NK programs. While early stage (1st patient only), the data is compelling and...
Turkey Shoot…December Preview
Well, that didn't last long, did it? On Tuesday and Wednesday we saw what looked like a great reversal for biotech. The XBI opened...
The Worst Bull Market Ever
Similar to how the richest billionaires are getting a disproportionate amount of the wealth in the US, the companies they founded are becoming an...
Notes from INKmune Update
On November 9th, I managed to catch up with Dr. Mark Lowdell, who runs the INKmune cancer program at INmune Bio (INMB). The call...
Asymmetric Risk
Intelligent investing can truly be boiled down to the understanding of risk and reward. In order to properly assess the potential risks of an...
INmune Bio, Inc. Announces Third Quarter 2021 Results and Provides Business Update
TW's Take: nice to see the additional data on INKmune as the first patient in the program continues to exceed expectations.
BOCA RATON, Fla., Nov....
Trick or Treat? October Review
Back when i was a kid, every Halloween the news covered stories of some whack job that would hand out apples to kids. The...
INmune Bio, Inc. Announces Multiple Oral and Poster Presentations at the 14th Clinical Trials...
TW's Take: INmune is changing the way CNS drug development will happen in the future with their innovations. These presentations highlight the innovation they...
Training My Thoughts
Rode the train up to DC from Charlottesville on Friday night and, let me tell you, despite all the years and money thrown at...
October Awaits
September to remember? I had such high hopes. Sadly, it turned out to be a very forgettable month and I'm happy to have it...
When The Tide Goes Out, You See Who’s Swimming Naked…
The markets had another downward-trending week since the last newsletter. However, the overall tone of the market felt better from a micro-cap investing standpoint...
Rolling Over? Markets Look Toppy To Me…
As I wrote about last week, we are entering what is historically the worst stretch of time for the market. I'm not sure why...
A September To Remember?
I read this week where someone said, "the short story is always sexier." There's certainly a lot of truth in that. Here in September...
Alzheimer’s Patients Treated with INmune Bio’s XPro™ Show Reduction in CSF Phospho-Tau and Evidence...
TW's Take: outstanding that demonstrates XPro195 is very effective in clearing neuroinflammation and reducing biomarkers associated with declining cognition. Very important PR that positions...
Small Caps Rebound…August Recap
I'm calling it a month. Normally, I'd wait until August is officially over before recapping things, but, since we only have two days of...
INKmune Induces Memory-Like NK Cells…This Is A Very Big Deal
In July, INmune Bio (INMB) dosed their first cancer patient with INKmune. Last night, we got an update on the program. Admittedly, there's only...
Old Fashioned Sunday
While the bankers and fund managers are heading out to the Hamptons for vacation, micro-cap earnings season kicked in last week and news flow...
INKmune: An Interview With INmune Bio’s Dr. Mark Lowdell
TW Research (TW): Dr. Lowdell, thanks for speaking with us today. I know you’ve been involved with INKmune since the very beginning and was...
Summer Stocks
The markets seem to be quieting down as summer heats up and traders are heading to the beach for the last few weeks of...
My Saturday Rant…
If you've been reading this newsletter for longer than two weeks, you likely have come to realize that I'm an investor not a trader....
INmune Bio, Inc. Announces Second Quarter 2021 Results and Provides Business Update
TW's Take: while we await the Alzheimer's data later in August, the INKmune program seems to be showing excellent activity at two weeks. Quellor...
Are We Having Fun Yet? Bull Ride Continues
The "bull" market continued this past week although it showed signs of tiring. Which is good because the bull ride we've been on resembles...
INmune Bio, Inc. Announces Design of Upcoming Phase 2 Alzheimer’s Disease Clinical Trial and...
TW's Take: Very exciting news. The data is compelling and improves over time. Meanwhile, having a rigorous, placebo controlled trial that only lasts 6...
July About to Close With a Bang?
Last week wasn't a bad week for the markets at all. With a nice two day rally to end the week, the Russell 2000...