Matinas BioPharma Holdings, Inc.

2022 Success Has Elevated Confidence to Focus LNC Supply Platform on the Way forward for Drugs – Delivering Genes

Prioritization on Constructing Exterior Partnerships and an Inside Pipeline Centered on Gene Therapies and Nucleic Acids

Collaborations with BioNTech (mRNA Companion) and Nationwide Resilience (Nucleic Acid Platform Companion) Anticipated to Generate Preliminary In Vivo Knowledge in 1H 2023

Searching for BARDA Monetary Help and FDA Suggestions on Part 3 Examine in Invasive Fungal Infections of MAT2203 Previous to Commencing Part 3 Program

Ended 2022 with Roughly $28.8 Million, Enough to Fund Deliberate Operations into Q2 2024

Convention Name and Stay Audio Webcast Scheduled Immediately, January 30 at 4:30 p.m. ET

BEDMINSTER, N.J., Jan. 30, 2023 (GLOBE NEWSWIRE) — Matinas BioPharma (NYSE AMER: MTNB, Matinas), a clinical-stage biopharmaceutical firm targeted on redefining the intracellular supply of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform expertise, right now is offering a enterprise replace on its ongoing packages and discussing its strategic outlook for 2023.

“In 2022 we efficiently demonstrated that MAT2203, our lead asset based mostly on our lipid nanocrystal (LNC) supply platform, may safely and successfully ship unprecedented survival outcomes, with an oral remedy, for sufferers affected by lethal fungal infections,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “Our success with smaller molecules elevated our confidence within the platform and empowered us to concentrate on what we imagine is the true future of medication – the power to securely and successfully ship therapies that have an effect on the genetic mechanisms underlying illness.   We’re striving to create an inside and exterior pipeline of product candidates within the nucleic acid and gene remedy house that reap the benefits of the distinctive and proprietary nature of our supply applied sciences. Our ongoing collaborations with BioNTech and, just lately, Nationwide Resilience, have aligned Matinas with two of the world’s main corporations within the gene remedy house. These collaborations had been designed to speed up the general improvement of our LNC platform and maximize the worth we are able to acquire from third events whereas offering us with important information and data vital to determine and develop an inside pipeline of nucleic acid therapies.”

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Jabbour added, “Throughout these unsure financial instances, we stay cognizant of our money sources and have chosen to prioritize these actions which we imagine will create the best shareholder worth. By means of these strategic selections, we now have prolonged our money runway into the second quarter of 2024, effectively past potential value-creating catalysts and near-term alternatives for non-dilutive funding from LNC companions and/or BARDA. We couldn’t be extra enthusiastic about what we’re constructing at Matinas, and we imagine that 2023 will likely be an awesome 12 months for the Firm and its shareholders.”

Key Program Updates and Anticipated Upcoming Milestones

LNC Platform Inside Knowledge Generated

(a)

Developed a number of movement cytometry and florescence cell-based assays with compelling validations of intracellular uptake and gene expression with our LNC formulations.

(b)

Profitable supply of a number of bigger nucleic acids coded with reporter genes throughout a number of cell strains (HeLa, HEK293, A375, and so forth.).

(c)

A number of oligonucleotide formulations which have demonstrated sturdy gene expression efficiency at nanogram per effectively dosage stage, similar to business commonplace Lipofectamine.

(d)

Inside mRNA formulations which have proven glorious stability and stay biologically energetic over 10 weeks at 4oC storage circumstances.

(e)

A number of formulations with little to no cytotoxicity throughout in vitro cell viability evaluations supporting an anticipated favorable security profile in contrast with different drug supply applied sciences.

LNC Inside Pipeline Growth

• Primarily based on historic information with the LNC platform, together with current learnings from inside work and its collaborations, the Firm believes the best likelihood of early success in creating our personal pipeline of nucleic acid drug candidates is with smaller oligonucleotides like antisense oligonucleotides (ASOs) and small interfering or silencing RNA (siRNAs). The properties of those molecules are notably suited to our LNC platform, and the Firm believes that its expertise can facilitate oral supply and extrahepatic focusing on – at present two of the best challenges on this creating space.

• The Firm has commenced a analysis program targeted on ASO/siRNAs that it expects will generate in vitro supply information early within the second quarter of this 12 months, adopted by a number of in vivo biodistribution and animal efficacy research within the second half of 2023. If profitable, the Firm anticipates being in place to establish our subsequent inside product candidate in late 2023. The Firm believes success in these research may place it to develop a complete pipeline of ASO and siRNA therapies.

LNC Platform Collaborations

• BioNTech – Signed Unique Analysis Collaboration in April 2022, together with $4.25 million in funding from our companion. The events are making ready for in vivo research (biodistribution and illness) through the first quarter of 2023, with information anticipated within the second quarter of 2023.

• Nationwide Resilience – In January 2023, the events entered right into a Materials Switch and Analysis Settlement targeted on exploring the potential for oral supply of recognized nucleic acids. The events are carefully collaborating on a complete analysis program comprising the design, formulation, optimization, and in vitro and in vivo testing of those nucleic acid codecs together with Matinas’ proprietary LNC platform, with preliminary information anticipated within the second and third quarters of 2023, respectively.

• Genentech – Genentech just lately prolonged this collaboration for one more 12 months via 2023.

• NIAID/Gilead – Whereas the sequence research carried out with LNC remdesivir had been profitable in demonstrating diminished viral lung titers, improved lung congestion scores and diminished COVID-associated weight reduction, Gilead has knowledgeable Matinas that it has targeted its improvement efforts on its inside oral nucleoside prodrug of remdesivir.

MAT2203 (oral amphotericin B) Program

• In November 2022, the Biomedical Superior Analysis and Growth Authority (BARDA) introduced an initiative searching for personal sector companions creating late-stage, broad-spectrum antifungal medicine to deal with excessive precedence fungal infections, together with aspergillus, mucormycosis, and sure types of candidiasis. BARDA has solicited proposals from business, and the Firm believes MAT2203 is a robust candidate for funding based mostly upon its oral, well-tolerated and broad-spectrum profile, together with its current medical success in Part 2 with cryptococcal meningitis. The Firm is scheduled to fulfill with BARDA through the first quarter of 2023 and has included all related prices for full improvement for MAT2203 in its proposal. The Firm believes pausing the beginning of its Part 3 medical trial in cryptococcal meningitis pending the end result of BARDA’s analysis of MAT2203 is the very best course for this life-saving drug. In 2021, BARDA funding for vaccines stood at $36.9 billion, therapeutics at $14.1 billion, and diagnostics at $51 million.

• The Firm is making ready to submit a proper Assembly Request to the U.S. Meals and Drug Administration (FDA) to debate plans for a second Part 3 examine to evaluate the efficacy, security, and tolerability of MAT2203 in sufferers with critical, life-threatening invasive fungal infections with restricted remedy choices. The protocol synopsis at present contains the remedy of 4 invasive fungal infections: invasive aspergillosis, invasive candidiasis, power coccidioidomycosis (Valley Fever), and invasive Mucormycosis.   The Firm’s technique is to leverage the success and information from EnACT to restrict the required dimension of this examine. The Firm at present plans to enroll roughly 100 sufferers in a single arm design with no head-to-head energetic comparator, which it believes must be acceptable given historic precedent and the challenges related to the goal affected person inhabitants to be evaluated. The Firm anticipates assembly with FDA within the second quarter of 2023 to debate its proposed design and technique for approval. The Firm believes that FDA steerage on this Part 3 examine is important to its BARDA proposal in addition to to potential home and international companions at present evaluating MAT2203, based mostly on suggestions acquired up to now.

• The success of MAT2203 within the EnACT Part 2 medical trial in cryptococcal meningitis has attracted the eye of clinicians and sufferers with out viable choices for the remedy of a wide range of fungal infections for which amphotericin B could also be appropriate, aside from vital considerations referring to the toxicity of the at present obtainable intravenous formulations of amphotericin B. At present, there are 4 (4) sufferers who’ve been permitted by FDA to obtain MAT2203 on an emergency use foundation since August of 2022, together with one affected person affected by each mucor and aspergillosis. General, these sufferers have responded effectively to remedy with MAT2203, with notable medical enhancements. The Firm will proceed to judge alternatives to offer MAT2203 on an emergency foundation for sufferers because it believes these are alternatives to showcase the protection and efficacy of MAT2203 exterior medical trial settings which characterize necessary further affected person information for each FDA and potential companions to evaluate.

Monetary Outlook

The Firm’s preliminary, unaudited estimate of money, money equivalents and marketable securities at December 31, 2022, is roughly $28.8 million, topic to completion of the audit of the Firm’s consolidated monetary statements for the 12 months ended December 31, 2022. This compares to $49.9 million at December 31, 2021. Primarily based on present projections, the Firm believes that money readily available is adequate to fund deliberate operations into the second quarter of 2024.

Convention Name and Webcast Particulars

The Firm will host a dwell convention name and webcast to debate this company replace and 2023 enterprise outlook right now, Monday, January 30 at 4:30 p.m. ET. To take part within the name, please dial (877) 407-5976 or (412)-902-0031. The dwell webcast will likely be accessible on the Traders part of Matinas BioPharma’s web site, www.matinasbiopharma.com, and archived for 90 days.

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical firm targeted on enhancing the intracellular supply of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform expertise. The Firm is creating its personal inside portfolio of merchandise in addition to partnering with main pharmaceutical corporations to develop novel formulations that capitalize on the distinctive traits of the LNC platform.

Preclinical and medical information have demonstrated that this novel expertise can present options to most of the challenges in reaching secure and efficient intracellular supply, for each small molecules and bigger, extra advanced molecules, resembling mRNA, DNA plasmids, antisense oligonucleotides, and vaccines. The mixture of a singular mechanism of motion and suppleness with formulation and route of administration (together with oral), positions Matinas’ LNC expertise to probably turn into the popular next-generation intracellular drug supply car with distinct benefits over each lipid nanoparticles and viral vectors.

For extra data, please go to www.matinasbiopharma.com.

Matinas Ahead-looking Statements

This launch accommodates “forward-looking statements” throughout the which means of the Non-public Securities Litigation Reform Act of 1995, together with these referring to our enterprise actions, our technique and plans, our collaborations with Nationwide Resilience and BioNTech SE, the potential of our LNC platform supply expertise, and the longer term improvement of its product candidates, the Firm’s capability to establish and pursue improvement, licensing and partnership alternatives for its merchandise or platform supply expertise on favorable phrases, if in any respect, and the power to acquire required regulatory approval and different statements which can be predictive in nature, that rely upon or discuss with future occasions or circumstances. All statements apart from statements of historic truth are statements that may very well be forward-looking statements. Ahead-looking statements embrace phrases resembling “expects,” “anticipates,” “intends,” “plans,” “may,” “believes,” “estimates” and related expressions. These statements contain identified and unknown dangers, uncertainties and different elements which can trigger precise outcomes to be materially totally different from any future outcomes expressed or implied by the forward-looking statements. Ahead-looking statements are topic to various dangers and uncertainties, together with, however not restricted to, our capability to acquire further capital to fulfill our liquidity wants on acceptable phrases, or in any respect, together with the extra capital which will likely be vital to finish the medical trials of our product candidates; our capability to efficiently full analysis and additional improvement and commercialization of our product candidates; the uncertainties inherent in medical testing; the timing, price and uncertainty of acquiring regulatory approvals; our capability to guard the Firm’s mental property; the lack of any government officers or key personnel or consultants; competitors; modifications within the regulatory panorama or the imposition of laws that have an effect on the Firm’s merchandise; and the opposite elements listed underneath “Danger Components” in our filings with the SEC, together with Types 10-Okay, 10-Q and 8-Okay. Traders are cautioned to not place undue reliance on such forward-looking statements, which converse solely as of the date of this launch. Besides as could also be required by legislation, the Firm doesn’t undertake any obligation to launch publicly any revisions to such forward-looking statements to mirror occasions or circumstances after the date hereof or to mirror the incidence of unanticipated occasions. Matinas BioPharma’s product candidates are all in a improvement stage and should not obtainable on the market or use.

Investor and Media Contacts

Ankit Bhargava, MD
Allele Communications, LLC
815.721.4912
matinas@allelecomms.com

Supply: Matinas BioPharma Holdings, Inc.