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Following is a comment I posted today on Biontech's website:
I am writing to you as a shareholder of both Biontech (BNTX) and Matinas Biopharma (MTNB).
It has been almost six months since BNTX paid almost $4 million USD for the exclusive negotiating rights to license MTNB's liquid nano crystal (LNC) delivery system.
Although I understand BNTX has had its scientists working with MTNB even before this six month exclusivity period started, no agreement has as yet been reached with MTNB.
It appears obvious that a collaboration with MTNB for use of its LNC delivery platform would be in the best interests of BNTX, MTNB, and the world, as it would allow BNTX's mRNA drugs--that now have to be administered intravenously, and stored at extremely cold temperatures--to be delivered orally, and stored, for many months, at room temperature.
LNC delivery has the added benefit of having far fewer side effects than delivery of mRNA drugs and vaccines using LNP.
In addition, because MTNB owns the rights to use of LNC, and BNTX's patents on LNP are being challenged by Moderna, and others, licensing MTNB's LNC delivery platform, for use with existing and future mRNA drugs and vaccines, provides for legal certainty that does not exist with LNP.
As I am sure you know, the safety and effectiveness of MTNB's LNC delivery system has recently been validated in a clinical trial for the LNC version of amphotericin b for patients with cryptococcal meningitis (CM) where an astounding 90-95% of the patients are still alive after six weeks, with minimal side effects. In that CM is 100% fatal if left untreated, and the LNC version of amp b handily bested the standard of care with far fewer adverse events, while crossing the blood brain barrier, these results are highly promising for BNTX's mRNA drugs and vaccines.
For all of these reasons, it is puzzling that BNTX would not have already entered into a licensing agreement with MTNB for use of its LNC delivery system.
I am sure BNTX has its reasons for not having already entered into a licensing agreement with MTNB. However, given the importance of this collaboration--not only to not to BNTX and MTNB, but to the world--I would urge BNTX to finalize its agreement with MTNB before its one-year exclusivity period ends in April 2023, when MTNB will be at liberty to license its LNC platform to Moderna, Pfizer, or any other companies who are developing mRNA drugs.
Thank you,
XXXXXXXXXXX
Shareholder of BNTX and MTNB
Matinas BioPharma Announces Positive Interim Data from the Phase 2 EnACT Trial of MAT2203 for the Treatment of Cryptococcal Meningitis, Exceeding Primary Endpoint Threshold; Patient Survival in All-Oral Cohort 4 Regimen Currently 90%
https://www.matinasbiopharma.com/investors/news-events/press-releases/detail/433/matinas-biopharma-announces-positive-interim-data-from-the
It has been over six months since BNTX paid almost $4 million for the exclusive rights to do a deal with MNTB to use its lipid nano crystal delivery platform for BNTX's mRNA drugs.
If the parties had decided to terminate this agreement, one or both would have presumably issued a press release.
Rather, today, at the Think conference, JJ confirmed this deal was still alive, and he hoped to close it, along with an agreement for MAT 2203, by the end of 2022.
My guess is that BNTX and MTNB are working on a really big deal that takes time to construct, and that potential partners are reviewing the data on the ENACT trial, given the stellar results announced to date.
If I am reading the tea leaves correctly, this could be a very happy new year for MTNB and its shareholders.
IDWeek 2022
Oral Encochleated Amphotericin B for Cryptococcal Meningitis:
a Phase lI Randomized Trial
Saturday, October 22, 2022
© 2:15 PM - 2:30 PM US ET
Presentinq Author(s)
Mucunguzi Atukunda, MBChB, MPH
Sub-Investigator
Infectious Diseases Institute, Makerere University
Kampala, Kampala, Uganda
Disclosure: I do not have any relevant financial / non-
financial relationships with any propretary interests.
Co-Author(s):
Enock Kagimu, MBChB
Morris K. Rutakingirwa, MBChB
https://idweek.org
Dr. Boulware's MSGERC 2022 (Sept) talk was published (valueforme)
Corporate Presentation September 2022
Matinas BioPharma to Present at the H.C. Wainwright 24th Annual Global Investment Conference
Tuesday, September 13, 2022, at 1:30 p.m
https://d1io3yog0oux5.cloudfront.net/_6a0b2271e38bd4b1bdf48c1999362729/matinasbiopharma/db/215/2501/pdf/Matinas+-+Investor+Relations+-+Corporate+Presentation+-+September+2022+%5BFINAL%5D.pdf
BioNTech comments:
"Very encouraged by the spirit of discussions which really began at the highest levels between Ugur and myself quite a while ago. That spirit has continued and we’re working to sort of finalize that, no update on timing, and we won’t be commenting on it more broadly other than on today’s call." - Jabbour
“Although these discussions have taken more time than perhaps was initially anticipated, the companies remain confident that they will find a mutually acceptable agreement. A license agreement of this potential magnitude and importance takes time and can be complicated, but Matins remains enthusiastic about its relationship and the prospects for a long-term partnership with BioNTech. Both parties continue to engage at the highest levels and with a positive outlook” - IR
"One thing you really have to be in biotech today is that you have to be opportunistic, you have to be flexible and you have to be willing to make the hard decisions. It's very difficult to be a single asset binary decision company, we're not that. We have a benefit of going into the number of different directions. We're doing that with the strength of clinical data. MAT2203 has provided that validation, BioNTech has provided additional validation and some excitement for the future. But we're just getting started in terms of identifying other nucleic acids that we think we can deliver in a way nobody else ever had. So for us it's not a race, this is a marathon. We're smart, we're prudent, we take advantage of the resources we have, we're cash conscious, but we're most focused on building a foundation of what is necessary for building a company that will become a true difference maker across therapeutic categories. Jabbour
“But we have time on our side. I mean, one of the advantages of having already -- have an ongoing relationship with BioNTech is that the science is not stopping. There’s no delay, while the parties figure out what the future looks like, in terms of advancing the platform and the delivery of messenger RNA and other nucleic acids.
And we want the right deal, we want the right deal for our technology, we want the right deal, we obviously have a fiduciary obligation to our shareholders. We think the precedents there. We’re confident that a deal is going to get done and it’s really about putting ourselves in position where we can maximize the opportunity be able to participate in a downstream way and incent BioNTech to create as many product candidates as we can. So that you do have an opportunity to have a meaningful commercial participation as they advance the field of messenger RNA.”
“And at the end of the day, BioNTech came to us, because we have something nobody else has.
And there is obviously a lot of competition in IP, confusion in the lipid nanoparticle space, number one.
And number two, from a technical perspective, our technology facilitates delivery in a way that none of these other technologies could ever imagine..” - Jabbour
Inflection Point(s)!
Pivotal Upcoming Catalysts:
- Sep/Apr BioNTech Deal Consummation
- Sep/Oct EnACT Cohort 4 Top-line Results
- Oct IDWeek (Preclinical data mucormycosis strains)
- TBD Gilead meeting (LNC Remdesivir Phase 1?)
- Nov Q3 Conference Call
- Nov/Dec EnACT Cohort 4 Full Detailed Results
- Q4 BioNTech preclinical results
- Q4/Q1 MAT2203 Partner Announcement
- Q4/Q1 MAT2501 Phase 2 Plan
- Q4/Q1 Fully-funded!
- Q4/Q1 MAT2203 Phase 3 Commencement!
- Q4/Q1 Genentech Phase 1 trial(s)?
- Q4/Q1 LNC/mRNA Phase 1 trial(s)?
January 9-13, 2023 in Kampala, Uganda
The premier meeting on Crypto meningitis
11th International Cryptococcus and Cryptococcosis Conference (ICCC)
If BNTX and MTNB were to collaborate, the combination would be formidable. BNTX, with its MRNA technology, and MTNB, with its lipid nano crystal delivery system, would result in MRNA drugs being safer, oral, and transportable at room temperature.
Great news ... ODD offers a lot of advantages. Looks like all the pieces are falling into place.
Matinas BioPharma Announces Positive Opinion by the European Medicines Agency on Orphan Drug Designation for MAT2203 for the Treatment of Cryptococcosis
July 25 2022 - 06:30AM
GlobeNewswire Inc.
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Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending MAT2203 for designation as an orphan medicinal product for the treatment of cryptococcosis. The U.S. Food and Drug Administration (FDA) previously granted Orphan, Qualified Infectious Disease Product (QIDP) and Fast Track Designations to MAT2203 for the treatment of cryptococcosis. Matinas is currently preparing to evaluate MAT2203 in a pivotal Phase 3 trial in patients with cryptococcal meningitis.
“The positive opinion for Orphan Drug Designation from the EMA is another important milestone for MAT2203 and reflects our commitment to position MAT2203 for global development and approval,” said Theresa Matkovits, Ph.D., Chief Development Officer of Matinas BioPharma. “We believe that MAT2203 has the potential to transform the treatment of cryptococcosis, as well as other deadly invasive fungal infections. This designation reflects the significant need for new therapies to treat fungal disease and we look forward to working with the EMA and FDA to potentially deliver MAT2203 to patients.”
The orphan medicinal product designation by the European Commission is granted to medicines that treat, prevent, or diagnose a life-threatening or chronically debilitating rare disease, with a prevalence in the EU of not more than five in 10,000 people, and with either no currently approved method of diagnosis, prevention, or treatment or with significant benefit to those affected by the disease. The designation potentially provides certain benefits to Matinas, including 10-year EU market exclusivity upon regulatory approval, if received, reductions in EMA application fees, and access to protocol assistance.
The FDA has previously designated MAT2203 as a QIDP with Fast Track Status and Orphan Drug Disease designation for three additional indications: the treatment of invasive candidiasis, and treatment of invasive aspergillosis, and the prevention of invasive fungal infections due to immunosuppressive therapy.
About MAT2203
MAT2203 is Matinas’ orally administered formulation of the broad-spectrum fungicidal medication amphotericin B, which is currently completing Phase 2 clinical development. This oral formulation utilizes the Company’s proprietary LNC technology to deliver amphotericin B in a way that targets infected tissues and avoids the toxicity normally seen with intravenously administered amphotericin B. This novel mechanism of oral delivery has the potential to make MAT2203 an important and invaluable treatment for invasive fungal infections like cryptococcal meningitis, mucormycosis, and invasive aspergillosis.
The entire market was off today,got a few shares in the .83 -.84 range.
Next week may bring BIG changes ,and the beginning of a transformation.
Stay tuned, & GLTA
Well another good day.Wait till NEWS starts coming out.The remaining months of 2022 are going to be a BLAST! The pipe line is full.This is a GROUND FLOOR OPT. THAT IS LAGIT,NOT SOME BS SHELL COMPANY.
Not a bad day,we are going to be hit by a LOT of news very soon.
Hope the momentum carries through today. Would like to see the beginning of waves of positive news.
2nd Half Deliverables (Potential to move the needle!)
Partners:
- BioNTech LNC Licensing Deal
- Global MAT2203 Partnership
- Oral LNC Remdesivir Histological Data
- Genentech’s LNC-FAB Collaboration Update
- Additional Paying BP Partner(s)
MAT2203:
- Interim Topline Data from Cohort4 of EnACT
- FDA P3 Registration Trial Meeting/Alignment
- Data from MAT2203 preclinical studies in C. auris and mucormycosis
MAT2501:
- Phase 2 Plan Funding
Sound science, patient/disciplined leadership & execution!
Let's go Matinas'
Current cash burn funded through beginning 2024 (~$45M)
Anyone know the company's cash on hand off the top of their head?
13th Global Drug Delivery & Formulation Summit
Berlin, 27th-29th June 2022
(1st conference in 3 years!)
Dr. Heinrich Haas, Vice President Formulation & Drug Delivery
BioNTech presents on June 28th, session title TBC
(valueforme)
Six weeks & counting!
- Good probability the BioNTech deal will be agreed before Dr. Heinrich takes the stage on the June 28th?
- Will Gilead ride their coattails and initiate Phase 1 LNC Remdesivir human trials?
- FDA in July (MAT2203)!
Setting up a Sizzling Summer!
Always a good sign when the TOP DOGS are hitting it off so to speak.Look forward to more details as this moves into mid,and end of year..
BioNTech Deal…
“The real wildcard here is just how much does BioNTech want to control the field of messenger RNA, and I think there’s obviously a great deal of value associated with something like that and a truly exclusive relationships, giving a multitude of areas that you can take messenger RNA vaccines, so that remains to be seen. Very encouraged by the spirit of discussions which really began at the highest levels between Ugur and myself quite a while ago. That spirit has continued and we’re working to sort of finalize that, no update on timing, and we won’t be commenting on it more broadly other than on today’s call.” (Jabbour)
MAT2203 Update
“Fundamentally, we understand .. you have the potential for a broad reach.. for all invasive fungal infections, so everything here is about positioning this drug to optimize its potential in being the key agent in the treatment of all invasive fungal infections.
..higher outside of the U.S., so it was a necessary approach for us whether we were going to completely hold onto this asset ourselves and build a global franchise or respond to the interests, comments and questions of parties who are interested in taking this drug and commercializing and developing it outside the U.S., that we had those necessary inputs to be able to inform strategic discussions, so harmony is key.
FDA has been a great foundation. The EMA now has the full data package. We’ll engage in those discussions in the third and fourth quarter of this year with the idea that we do want total alignment here because it will help us and our partner to optimize the value of this drug.” (Jabbour)
LNC Remdesivir Update
"First, we very recently received data from the second in vivo study of oral LNC remdesivir in mice infected with SARS-CoV-2. The study.. demonstrated that an oral LNC formulation of remdesivir significantly reduced viral lung titres as early as day two, significantly improved lung congestion scores, and significantly improved COVID-associated weight loss in a well established model of SARS-CoV-2. We are still waiting final histological analyses and will shortly be discussing next steps with the NIAID and Gilead. These data are important for two reasons: first, the therapeutic efficacy against SARS-CoV-2 of an oral formulation of remdesivir itself, and second, the very encouraging early knockdown of lung viral titres, something that might not otherwise be expected with conventional IV remdesivir." (Ferguson)
Jabbour excerpts:
“With Gilead.. they do have and have developed a pro-drug of remdesivir - it’s not remdesivir, to be clear, that they have also studied in pre-clinical models at UNC.
Ours actually is an oral version of remdesivir, which obviously has regulatory advantages as you think about streamlined development pathways, so the enthusiasm is there.
For us, we need the full data set from UNC and NIH. We’re still waiting on the histo. We will reengage with Gilead at that time, although they’ve already seen the data generated to date.
..We certainly are interested in continuing to engage with Gilead and really optimizing the potential remdesivir has as an oral--actual remdesivir as an oral drug, .. We would expect at some point that this data will be published, and that’s something that remains under discussion with Gilead.”
May Update (Slides 13 & 14)
https://d1io3yog0oux5.cloudfront.net/_39593dbf8dddbc5842c6eb613c099aae/matinasbiopharma/db/215/2522/pdf/Matinas+-+Investor+Relations+-+Corporate+Presentation+-+May+2022+FINAL+05.012.22.pdf
Conviction Thesis (checking the boxes):
- Sound Science (w/an Acute Need)!
- Viable Product/Platform (evidence-based/clinically de-risked)!
- Competent Leadership & Execution (No selling in years)!
- Clear Regulatory Path (FDA access w/Breakthroughs)!
- Disciplined Capital Allocation (Cash thru ’23 & No debt)!
- Huge TAM’s (Realizable & Recurring)!
- Wholly-owned Broad, Deep & Extendable Patent/Knowledge Moat!
BioNTech deal on a path for decision by June 28th!
Gilead news also should be by end of June!
Not expecting any market moving updates next week other than confirmation everything is proceeding as expected (e.g. Great News!)!
Long & Strong!
MTNB will be $3 soon. A good stock, lately, more news about MTNB
Good price to keep buying. Best wishes everyone
I expect big things for MTNB's share price once it licenses use of its liquid nano crystal drug delivery system to BNTX. MTNB's LNC drug delivery system--which is far more effective and less toxic than the liquid nano particle system now used by BNTX and other vaccine makers--will enable BNTX to make its injectable vaccines oral, without the side effects normally associated with MRNA therapeutics delivered using LNPs.
According to MTNB, a licensing agreement with BNTX is expected within the next few months.
Very impressive. THANKS RFF
Needham Webcast w/CEO Jabbour (4/13/22)
https://wsw.com/webcast/needham117/mtnb/2255483
Registration required
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Keep BUYIN till our MTNB reachin $3. Good news today !
Good Luck for everyone hanging on with MTNB for so long!
---------------------------------
H.C. Wainwright Sticks to Its BUY Rating for Matinas BioPharma (MTNB)
April 11 2022 - 11:05AM
TipRanks
In a report released today, Andrew Fein from H.C. Wainwright reiterated a Buy rating on Matinas BioPharma (MTNB – Research Report), with a price target of $3.00. The company's shares closed last Monday at $0.79.
According to TipRanks.com, Fein has 0 stars on 0-5 stars ranking scale with an average return of -5.3% and a 37.8% success rate. Fein covers the Healthcare sector, focusing on stocks such as DBV Technologies SA - American, Amylyx Pharmaceuticals Inc, and Deciphera Pharmaceuticals.
The word on The Street in general, suggests a Strong Buy analyst consensus rating for Matinas BioPharma with a $3.00 average price target.
https://www.tipranks.com/news/blurbs/h-c-wainwright-sticks-to-its-buy-rating-for-matinas-biopharma-mtnb?utm_source=advfn.com&utm_medium=referral
Matinas BioPharma to Present at the Needham Virtual Healthcare Conference
https://www.matinasbiopharma.com/investors/news-events/press-releases/detail/418/matinas-biopharma-to-present-at-the-needham-virtual
Oral remdesivir update (CEO Jabbour - Maxim Virtual - Mar 28th)
"Beginning 2nd in vivo study in 2nd quarter, a lot of enthusiasm around that"
"very difficult to treat Covid-19 model"
"data should be available in the 2nd quarter"
(sponsored by NIAID/Gilead)
Studies conducted by UNC
Matinas BioPharma to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and Hosted by M-Vest
https://www.globenewswire.com/news-release/2022/03/22/2407415/32419/en/Matinas-BioPharma-to-Participate-in-the-2022-Virtual-Growth-Conference-Presented-by-Maxim-Group-LLC-and-Hosted-by-M-Vest.html
Some cc excerpts (CEO Jabbour - Mar 8)
"I would also like to take a few moments to expand on our stated strategic intentions of moving aggressively with our LNC platform technology into the delivery of nucleic acids, including messenger RNA, DNA and antisense oligonucleotides.
We believe that the unique attributes of our delivery platform could position Matinas’s LNC technology to become the next generation drug delivery platform for the intracellular delivery of nucleic acid.
The unique properties of our LNC platform, including oral bioavailability, extrahepatic targeting, large payload capacity and improved stability and safety are supported by key preclinical data that differentiates our technology from both lipid nanoparticles or LNPs and viral vectors.
Despite advances and treatments comprising nucleic acids, including the vaccines, safe and efficient intracellular delivery remains perhaps the greatest challenge to the effectiveness of these therapies as both LNPs and viral vectors have significant limitations.
- LNP’s are limited and that they can typically only access the cell via classroom mediated endocytosis, followed by disruption of the endosomes membrane within the cell to gain access to the cytoplasm.
- LNP’s typically are very inefficient and patients can also experience injection site adverse events and other toxicity, thereby limiting chronic or repeated use.
- LNP’s cannot be delivered orally in a very unstable requiring extreme cold chain storage temperatures to maintain their integrity.
- Unfortunately, viral vectors have historically been associated with severe negative immune responses and, like LNPs, cannot be delivered orally.
We believe LNCs provide a differentiated alternative to LNP and vector delivery.
- LNCs can effectively deliver molecules through both endocytosis and membrane fusion in addition to having great flexibility with the desired route of administration.
- Because of their unique structure and delivery mechanisms LNC formulations are not immunogenic and allow for safe, repeated administration, no significant drawbacks that have been observed with vectors in LNPs.
- The structure of an LNC is also highly stable, protecting the payload both prior to and following administration into the body.
- This stability obviates the need for the extreme cold chain storage temperatures otherwise required for maintaining the integrity of LNPs.
- This specific cellular targeting coupled with the potential to deliver a broad range of therapeutic agents, including small molecules, vaccines peptides and proteins, as well as nucleic acid polymers, provide a broader array of potential targets and modalities, from which to create a broad pipeline of internal product candidates and partnerships.
We remain in advanced discussions with leading biopharmaceutical companies in the nucleic acid space.
Unlike numerous other companies in the LNP area, Matinas is the only company working with LNCs and we have built a significant intellectual property portfolio combined with decades of know-how to protect what we believe can become the next generation platform in intracellular delivery."
EnACT Cohort 4 initial enrollees now crossing 30 day survival!
Cohort 4 > 25% enrolled with interim data expected in Q3!
Interview with CEO Jerome D. Jabbour
$MTNB Matinas BioPharma is a clinical-stage biopharmaceutical company redefining the intracellular delivery of nucleic acids & small molecules with its lipid nanocrystal, or LNC, platform delivery tech. Learn about Matinas & LNC in this interview with CEO Jerome D. Jabbour.#ad pic.twitter.com/cL3xKf6SZB
— Benzinga (@Benzinga) February 9, 2022
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