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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
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)
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)
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!
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!
Needham Webcast w/CEO Jabbour (4/13/22)
https://wsw.com/webcast/needham117/mtnb/2255483
Registration required
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
Matinas BioPharma Provides Business Update and 2022 Strategic Outlook
https://finance.yahoo.com/news/matinas-biopharma-provides-business-2022-113000818.html
You read my previous post!
- Authorized 1:2 - 1:15 RS (Jan ’21 / Expires January 26, ’22)
Could be, perhaps they shouldn't waste it, we'll know soon!
Regardless, zero change to valuation!
Conviction: Matinas check all the boxes:
- Sound Science!
- Viable Product/Platform (clinically de-risked)!
- Strong Competent Team! (No selling!)
- Financially Sound (Cash til ’24 & No debt!)
- Huge TAM’s (Realizable & Recurring)
- Broad/Long Patent/Knowledge Moat
- Reasonable Valuation (in some cases irrational :)
Save the date - Matinas BioPharma to Provide Corporate Update and 2022 Business Outlook
Matinas will host a conference call and live audio webcast on Tuesday, January 25th, at 8:30 a.m. ET to discuss the Company's business outlook for 2022. Dial-in and webcast details here:
Save the date - Matinas will host a conference call and live audio webcast on Tuesday, January 25th, at 8:30 a.m. ET to discuss the Company's business outlook for 2022. Dial-in and webcast details here: https://t.co/B4wDjQVWks $MTNB
— Matinas BioPharma (@MatinasBio) January 20, 2022
Save the date - Matinas BioPharma to Provide Corporate Update and 2022 Business Outlook
Matinas will host a conference call and live audio webcast on Tuesday, January 25th, at 8:30 a.m. ET to discuss the Company's business outlook for 2022. Dial-in and webcast details here:
Save the date - Matinas will host a conference call and live audio webcast on Tuesday, January 25th, at 8:30 a.m. ET to discuss the Company's business outlook for 2022. Dial-in and webcast details here: https://t.co/B4wDjQVWks $MTNB
— Matinas BioPharma (@MatinasBio) January 20, 2022
Conviction that they check all the boxes:
- Sound Science!
- Viable Product/Platform (clinically de-risked)!
- Strong Competent Team! (No selling!)
- Financially Sound (Cash til ’24 & No debt!)
- Huge TAM’s (Realizable & Recurring)
- Broad/Long Patent/Knowledge Moat
- Reasonable Valuation (in some cases irrational :)
Getting interesting!
Pivotal Month! (Jan ’22)
- FDA discussions revealed ?
- EnACT Final Registration Phase ?
- NIH/NIAID LNC OralRem Phase 1 initiated ?
- Institutional Support/Accumulation !
Need $$’s to Broaden Pipeline/TAM!
- Trials currently funded by NIH & CFF
- Commercial Revenue ’23 ?
- BP Deals ?
Treasury (misc factoids)
- Outstanding Shares ~216M (Fully diluted ~250M)
- Valuation <$200M
- Cash ~$60M (No Debt)
- Qtly Burn ~$5M
- Last raise ~$50M @ $1.55 (Jan ’20)
- Authorized $200M Shelf (July ’20)
- Authorized 1:2 - 1:15 RS (Jan ’21 / Expires January 26, ’22)
Tuesday’s 2022 update, lot’s of moving parts, some stuff:
1) We want to hear feedback from the FDA meeting (hopefully no delays?), specifically;
A) Will they accept EnACT’s Phase 2 trial as a sufficient (e.g. registrational) to approve?
- Initially for Step-down (based on Cohort 1 & 2)
- Subsequently for Consolidation (based on 1-4)
- Ultimately for Induction (based on Cohort 4)
Or will they require a Phase 3 Trial (larger population/other geographies/US patients?)
B) Guidance on what's the fastest approval track possible (given they have multiple fast-track designations)?
- Matinas wants to know what the shortest point between A & B (regardless of what you call it!)
* Note: They already mentioned they expect a Phase 3 (all-in) trial for other IFI indications!
2) MAT2203 “Go to Market” Strategy/Funding?
3) NIH/UNC in vivo study update?
4) Genentech’s collaborations/next steps?
5) New Partners/Licensing deals (cash)?
6) Treasury Update (RS, Uplisting plans, ..)?
7) Complete 5-year MAT2203 data (Dec scheduled completion)
8) Update of MAT2501 Phase 1 / CFF next round funding?
Thank you!
Thank you! Appreciate all the input!
Happy New Years!
I have the option of selecting Medicare Part D, but haven't been able to confirm if Vascepa is covered?
Appreciate any input, signing up for Medicare (located in Massachusetts) and wondering best drug plan for Vascepa coverage or a heads-up on a link! ? Currently paying about $150 per month through BCBS of MA (previously paid $9 per month prior to generics). Thanks in advance!
Oral LNC/Remdesivir may not only be more efficacious, but safer!
Which would you opt for?
- Remdesivir blocks replication
- Molnupiravir propagates errors in replication
"both molnupiravir and Veklury are incorporated by the viral RNA polymerase, with molnupiravir being a viral genome mutagen and Veklury blocking replication done by the polymerase"
"Side effect concerns have been raised about whether molnupiravir could be metabolised into a precursor of DNA, Swanstrom said, explaining it could enter the host cell nucleus, leading to oncogenesis."
https://www.clinicaltrialsarena.com/comment/ridgeback-mercks-molnupiravir-for-covid-19-has-moa-administration-advantages-but-phase-iia-faces-execution-obstacles-may-have-value-gaps/
Merck's Oral CV19 Therapeutic - Black Box?
https://www.drugdiscoverytrends.com/early-safety-concerns-accompanied-mercks-molnupiravir-the-first-potential-oral-covid-19-therapy/
Change your travel plans
11th International Cryptococcus and Cryptococcosis Conference (ICCC) has been rescheduled for January 9-13, 2023 in Kampala, Uganda.
11th International Cryptococcus and Cryptococcosis Conference (ICCC) has been rescheduled for January 9-13, 2023 in Kampala, Uganda. #IDtwitter #HIVTwitter
— David Boulware, MD MPH (@boulware_dr) September 27, 2021
The premier meeting on #Crypto meningitis pic.twitter.com/cGD05QQYa1
Gilead might be able to leapfrog the competition, if only they had access to a technology that could be formulated as a natural, non-toxic and highly efficient intracellular oral treatment, hmmm…
https://www.yahoo.com/news/daily-pill-treat-covid-could-083032667.html
Let's repeat until it's clear and mainstream
95% survival rate for HIV patients with cryptococcal meningitis at 10 and 18wks with encochleated amphotericin B beats SoC and challengers by 20+ miles
Cohort 2 tells us cohort 4 should succeed with a high probability. Recall patients were sick for weeks before hospitalization so what's an extra 2 days of loading dose of amphotericin B injection replaced by MAT2203 at hospitalization really going to affect. Nothing much. All signs point to MAT2203 doing the bulk work of fungal sterilization of the brain.
You can bet what BPs wouldn't give to provide an oral formulation that works to deliver commonly undruggable treatments for any disease associated to inflammation. I said for years. Many diseases are related to inflammation. Many. Arbutus investors should consider putting one foot in LNC now. Do your DD on (oral) BCS class IV drugs and tell me who else can do it. Extremely few. Thought so (Antihydrogen)
This week is Fungal Disease Awareness Week!
(David Boulware, MD MPH Retweeted)
Next week is Fungal Disease Awareness Week!
— MSGERC (@MSG_ERC) September 17, 2021
Please join us on Monday Sept 20 at noon EDT for an #OpenMyc chat to discuss all things fungal diseases! #ThinkFungus pic.twitter.com/w8b61BHVqm