What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-04-15 · 323 added, 377 removed, 844 unchanged (45% of the section changed)

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(“Matinas” or the “Company”) is a clinical-stage biopharmaceutical company focused on

delivering groundbreaking therapies using our lipid nanocrystal (“LNC”) platform delivery technology (LNC Platform).

delivering groundbreaking therapies using our lipid nanocrystal (“LNC”) platform delivery technology (the “LNC Platform”).

lead product candidate is MAT2203 (oral amphotericin B), a highly potent antifungal drug which, by virtue of LNC delivery, has been made

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focus on inflammation.

an 80% reduction in workforce implemented in late October 2024, the Company implemented a cost-cutting strategy and paused further

clinical development of MAT2203 while continuing to engage in dialogue with prospective partners for the product with the goal of

consummating a licensing, sale or other similar transaction as soon as possible to advance the development of MAT2203 into Phase 3.

In addition, the Company continues to engage with the FDA to keep the MAT2203 Investigational New Drug Application

(“IND”) active and is actively maintaining and prosecuting intellectual property relating to MAT2203 and to the LNC

Platform generally as well as maintaining all of its obligations under our license agreement with Rutgers University.

continue to support the patients in our Expanded/Compassionate Use Access Program with the assistance of outside medical clinician

As a result of the reduction in force, the Company has paused the internal development of a pipeline of products

utilizing the LNC Platform as it evaluates strategic alternatives for those early-stage programs in oncology and inflammatory

We remain engaged in an ongoing partnership process

for MAT2203, seeking one or more development and/or commercialization partners.

We will require either (i) the consummation of a partnership

transaction, or (ii) raising additional capital, prior to commencing the ORALTO trial.

In the event a partnership is consummated, the

partner may seek to revise the ORALTO trial or could determine a completely new development program and pathway for MAT2203.

be no assurance that the Company will be successful in consummating a transaction involving MAT2203.

September 21, 2023, Matinas Biopharma Holdings, Inc.

(the “Company”) received

a deficiency letter (the “Letter”) from the NYSE American LLC (the “NYSE

American” or the “Exchange”) indicating that the Company is not in compliance

with the NYSE American continued listing standard set forth in Section 1003(f)(v) of the

NYSE American Company Guide due to its shares of common stock selling for a substantial period

of time at a low price per share, which NYSE American determined to be a 30 trading day average

price of less than $0.20 per share.

On March 22, 2024, Matinas BioPharma Holdings, Inc.

“Company”) announced that on March 21, 2024, the Company received a letter from

the NYSE American LLC (the “NYSE American”) indicating that the Company had regained

compliance with the NYSE American continued listing standard set forth in Section 1003(f)(v)

of the NYSE American Company Guide due to its shares of common stock demonstrating sustained

price improvement.

November 1, 2023, at the 2023 annual meeting of stockholders of the Company, the stockholders

approved the authorization of the Board of Directors (the “Board”), in its sole

and absolute discretion and without further stockholder approval, to (i) reduce the total

number of authorized shares of the Company’s Common Stock, from 500,000,000 to 250,000,000

(the “Authorized Share Reduction”), and (ii) effect a reverse stock split of

the Common Stock at a ratio to be determined by the Board ranging from a ratio of one-for-two

(1:2) to a ratio of one-for-fifty (1:50).

February 2024, we announced agreement with the United States Food and Drug Administration

(“FDA”) on the design of a single Phase 3 registration trial of MAT2203 in patients

with invasive aspergillosis who have limited treatment options, including consensus on all

critical elements of the ORALTO trial.

March 2024, we announced that the Company would require either (i) the consummation of a

partnership transaction, or (ii) raising significant additional capital, prior to commencing

the ORALTO trial.

The Company continued to support (a) the ongoing MAT2203 Compassionate/Expanded

Use Access Program, (b) all MAT2203 regulatory requirements, (c) the prosecution and maintenance

of all intellectual property relevant to MAT2203 and the LNC Platform and (d) the early stage

research and development of other applications of the LNC Platform in the oncology and inflammation

April 2, 2024, we announced entry into a securities purchase agreement (the “April

2024 Purchase Agreement”), with certain institutional investors (collectively, the

“April 2024 Purchasers”).

The April 2024 Purchase Agreement provided for the

sale and issuance by the Company of (i) 666,667 shares (the “April 2024 Shares”)

of the Company’s common stock, $0.0001 par value per share (the “April 2024 Common

Stock”) and warrants to purchase up to 666,667 shares of Common Stock (the “Warrants”

and, together with the April 2024 Common Stock, the “April 2024 Securities”).

The offering price per share and accompanying warrants was $15.00.

The April 2024 Warrants

have an exercise price of $17.50 and were exercisable beginning October 2, 2024, and expire

on the five-and-a-half year anniversary of the date of issuance.

The offering resulted in

gross proceeds to the Company of approximately $10 million before deducting placement agent’s

fees and related offering expenses.

August 20, 2024, pursuant to the NYSE American’s Compliance Guidance Memo which requires

ten calendar days public notice for certain corporate actions, the Company announced that

the Board approved the Authorized Share Reduction and a reverse stock split of the Common

Stock at a ratio of one-for-fifty (1:50) (the “Reverse Stock Split”), which would

become effective at 5:00PM (EST) on August 30, 2024.

August 27, 2024, the Company received notice that trading of its shares of Common Stock had

been halted by the NYSE American due to its low trading price.

The trading halt remained

in effect until after the Company consummated the communicated reverse stock split of the

Common Stock and the market opened on September 3, 2024.

August 30, 2024, the Authorized Share Reduction and the Reverse Stock Split became effective

(EST) and the shares of Common Stock began trading on the split-adjusted basis

under the Company’s existing trading symbol, “MTNB,” when the market opened

on September 3, 2024.

October 31, 2024, we announced that negotiations under a non-binding term sheet with a single

partner for global licensing rights to develop, manufacture and commercialize MAT2203 for

all future treatment indications (the “MAT2203 Term Sheet”), including the intended

initial indication of treatment for patients with invasive aspergillosis with limited or

no other treatment options, were terminated following notification from the perspective partner

for reasons unrelated to MAT2203.

As a result, we implemented an immediate 80% workforce

reduction, eliminating 15 positions, including three members of senior management, and ceased

certain product development activities to preserve cash while we evaluated a potential sale

of MAT2203 and/or other strategic alternatives, including a potential winddown or dissolution

of the Company.

January 6, 2025, we announced that we received a deficiency letter (the “ January 2025

NYSE Notice”) from the NYSE American stating that the Company failed to hold an annual

meeting of stockholders during the fiscal year ended December 31, 2024, as required by Section

704 of the Company Guide.

The January 2025 NYSE Notice has no immediate impact on the listing

of the Company’s common stock, which will continue to be listed and traded on the NYSE

American during the applicable cure period but will be assigned a “.BC” indicator

by the NYSE to indicate that the Company is below compliance.

The “.BC” indicator

will be removed at such time as the Company is deemed compliant with the NYSE’s continued

listing standards.

The Company intends to hold its annual meeting no later than December

31, 2025 in order to regain compliance under the Company Guide.

February 13, 2025, we announced that the Company entered into a securities purchase agreement

(the “February 2025 Agreement”) with a certain group of investors (the “February

2025 Investors”), pursuant to which they agreed to purchase from the Company 3,300

shares of Series C Convertible Preferred Stock (the “Preferred Stock”) and warrants

to purchase up to 11,262,808 shares of common stock (the “February 2025 Warrants”)

at a purchase price of $1,000 per share of Preferred Stock and accompanying warrants for

aggregate gross proceeds of $3.3 million before deducting offering expenses payable by the

The February 2025 Investors purchased 1,650 shares of Preferred Stock and accompanying

warrants to purchase up to 5,631,404 shares of common stock for gross proceeds to the Company

of $1.65 million at an initial closing on February 13, 2025.

Subject to the satisfaction

of certain closing conditions, the Investors paid an additional $1.65 million

in exchange for an additional 1,650 shares of Preferred Stock and accompanying warrants to

purchase up to 5,631,404 shares of common stock at a second closing on April 8, 2025.

The shares of Preferred

Stock will be convertible into common stock at a conversion price of $0.586, and each share

of Preferred Stock is initially convertible into 1,706 shares of common stock.

will have an exercise price of $0.6446 per share, will be exercisable, subject to certain

exceptions, beginning on the effective date of the Shareholder Approval and will expire five

years from the effective date of the Shareholder Approval.

funds will be used for general corporate purposes, with a focus on reducing operating expenses and exploring strategic alternatives for

MAT2203, the Company’s Phase 3-ready antifungal drug candidate for the treatment of invasive fungal infections, as well as other

strategic alternatives for the Company.

In connection with the February 2025 Agreement, Dr.

Smith, MD, MBA has been appointed

to the Board of Directors.

March 3, 2025, we filed a Notice of Special Meeting of Stockholders to be held on April 4,

2025 (the “Special Meeting).

At the Special Meeting, stockholders will act on the following

(1) to approve, for purposes of complying with the applicable provisions of Section

713 of the NYSE Company Guide (a) the issuance of up to an aggregate of 16,894,212 shares

of common stock upon the conversion of the Preferred Stock and the exercise of the February

2025 Warrants (the “Stock Issuance Proposal”), and (b) the terms thereof, which

may constitute a “Change of Control” as defined in the NYSE Company Guide;

(2) to ratify the appointment of EisnerAmper LLP as our independent registered public accounting

firm for the year ended December 31, 2025.

an 80% reduction in workforce implemented in late October 2024, we implemented a cost-cutting strategy and paused further clinical development

of MAT2203 while continuing to engage in dialogue with prospective partners for the product with the goal of consummating a licensing,

sale or other similar transaction as soon as possible to advance the development of MAT2203 into Phase 3.

In addition, we continue to

engage with the United States Food and Drug Administration (“FDA”) to keep the MAT2203 Investigational New Drug Application

(“IND”) active and are actively maintaining and prosecuting intellectual property relating to MAT2203 and to the LNC Platform

generally as well as maintaining all of our obligations under our license agreement with Rutgers University.

We also continue to support

the patients in our Expanded/Compassionate Use Access Program with the assistance of outside medical clinician consultants.

of the reduction in force, we have paused the internal development of a pipeline of products utilizing the LNC Platform as we evaluate

strategic alternatives for those early-stage programs in oncology and inflammatory diseases.

remain engaged in an ongoing partnership process for MAT2203, seeking one or more development and/or commercialization partners.

require either (i) the consummation of a partnership transaction, or (ii) raising additional capital, prior to commencing the ORALTO

In the event a partnership is consummated, the partner may seek to revise the ORALTO trial or could determine a completely new

development program and pathway for MAT2203.

There can be no assurance that we will be successful in consummating a transaction involving

February 2024, we announced agreement with the FDA on the design of a single Phase 3 registration trial of MAT2203 in patients with

invasive aspergillosis who have limited treatment options, including consensus on all critical elements of the ORALTO trial.

March 2024, we announced that we would require either (i) the consummation of a partnership transaction, or (ii) raising significant

additional capital, prior to commencing the ORALTO trial.

We continued to support (a) the ongoing MAT2203 Compassionate/Expanded

Use Access Program, (b) all MAT2203 regulatory requirements, (c) the prosecution and maintenance of all intellectual property relevant

to MAT2203 and the LNC Platform and (d) the early stage research and development of other applications of the LNC Platform in the

oncology and inflammation spaces.

April 2, 2024, we announced entry into a securities purchase agreement (the “April 2024 Purchase Agreement”), with certain

institutional investors.

The April 2024 Purchase Agreement provided for the sale and issuance by the Company of (i) 666,667 shares

of common stock and warrants (the “April 2024 Warrants”) to purchase up to 666,667 shares of common stock.

price per share and accompanying warrant was $15.00.

The April 2024 Warrants have an exercise price of $17.50, were exercisable beginning

October 2, 2024 and expire on the five-and-a-half year anniversary of the date of issuance, or October 5, 2029.

The offering resulted

in gross proceeds to the Company of approximately $10 million before deducting placement agent’s fees and related offering

August 20, 2024, pursuant to the NYSE American’s Compliance Guidance Memo which requires ten calendar days public notice for

certain corporate actions, we announced that our Board of Directors (the “Board”) approved a reduction in the total number

of authorized shares of our common stock from 500,000,000 to 250,000,000 (the “Authorized Share Reduction”) and a reverse

stock split of the common stock at a ratio of one-for-fifty (1:50) (the “Reverse Stock Split”), which would become effective

at 5:00PM (EST) on August 30, 2024.

August 27, 2024, we received notice that trading of our shares of common stock had been halted by the NYSE American due to its low

trading price.

The trading halt remained in effect until after we consummated the communicated reverse stock split of the common

stock and the market opened on September 3, 2024.

August 30, 2024, the Authorized Share Reduction and the Reverse Stock Split became effective at 5:00 P.M.

(EST) and the shares of

our common stock began trading on the split-adjusted basis under the Company’s existing trading symbol, “MTNB,”

when the market opened on September 3, 2024.

October 31, 2024, we announced that negotiations under a non-binding term sheet with a single partner for global licensing rights

to develop, manufacture and commercialize MAT2203 for all future treatment indications (the “MAT2203 Term Sheet”), including

the intended initial indication of treatment for patients with invasive aspergillosis with limited or no other treatment options,

were terminated following notification from the perspective partner for reasons unrelated to MAT2203.

As a result, we implemented

an immediate 80% workforce reduction, eliminating 15 positions, including three members of senior management, and ceased certain

product development activities to preserve cash while we evaluated a potential sale of MAT2203 and/or other strategic alternatives,

including a potential winddown or dissolution of the Company.

January 10, 2025, we announced that we received a deficiency letter (the “January 2025 NYSE Notice”) from the NYSE American

stating that the Company failed to hold an annual meeting of stockholders during the fiscal year ended December 31, 2024, as required

by Section 704 of the NYSE American Company Guide.

The January 2025 NYSE Notice had no immediate impact on the listing of our common

stock, which continued to be listed and traded on the NYSE American during the applicable cure period but was assigned a “.BC”

indicator by the NYSE American to indicate that the Company was below compliance.

We received a letter from the NYSE American on

June 23, 2025 that we had resolved the deficiency set forth in the January 2025 NYSE Notice by virtue of holding our Annual Meeting

for the fiscal year ended December 31, 2023 on June 23, 2025.

As a result, the BC indicator was removed from our stock symbol.

February 13, 2025, we entered into a securities purchase agreement (the “February 2025 Agreement”) with a certain group

of investors (the “February 2025 Investors”), pursuant to which they agreed to purchase from the Company 3,300 shares

of our Series C Convertible Preferred Stock, par value $0.0001 per share (the “Preferred Stock”), and warrants to purchase

up to 11,262,808 shares of common stock (the “2025 Warrants”) at a purchase price of $1,000 per share of Preferred Stock

and accompanying 2025 Warrants, for aggregate gross proceeds of $3.3 million before deducting offering expenses payable by the Company.

The February 2025 Investors purchased 1,650 shares of Preferred Stock and accompanying 2025 Warrants to purchase up to 5,631,404

shares of common stock for gross proceeds to the Company of $1.65 million at an initial closing on February 13, 2025.

the satisfaction of certain closing conditions, the February 2025 Investors purchased an additional 1,650 shares of Preferred Stock

and accompanying 2025 Warrants to purchase up to 5,631,404 shares of common stock for gross proceeds to the Company of $1.65 million

at a second closing on April 8, 2025.

The shares of Preferred Stock are convertible into common stock at a conversion price of $0.586,

and each share of Preferred Stock is initially convertible into 1,706 shares of common stock.

The 2025 Warrants have an exercise

price of $0.6446 per share.

The 2025 Warrants purchased in the initial closing became exercisable on April 4, 2025, the effective

date of the approval by our stockholders of the Stock Issuance Proposal (as defined below) (the “Shareholder Approval”)

and will expire five years from the effective date of the Shareholder Approval, or April 4, 2030.

The 2025 Warrants purchased in

the second closing were immediately exercisable and will expire on April 8, 2030.

In connection with the February 2025 Agreement,

Smith, MD, MBA was appointed to the Board.

March 3, 2025, we filed a Notice of Special Meeting of Stockholders to be held on April 4, 2025 (the “Special Meeting).

the Special Meeting, stockholders approved:

(1) for purposes of complying with the applicable provisions of Section 713 of the NYSE

American Company Guide (a) the issuance of up to an aggregate of 16,894,212 shares of common stock upon the conversion of the Preferred

Stock and the exercise of the 2025 Warrants (the “Stock Issuance Proposal”), and (b) the terms thereof, which may constitute

a “Change of Control” as defined in the NYSE American Company Guide;

and (2) ratified the appointment of EisnerAmper

LLP as our independent registered public accounting firm for the year ended December 31, 2025.

April 30, 2025, we amended our bylaws to reduce the quorum requirement for stockholders meetings from a majority to one-third of

the voting power of the outstanding shares of capital stock entitled to vote at such meeting.

June 23, 2025, at our annual meeting of stockholders, our stockholders approved (i) an amendment to our Certificate of Incorporation,

as amended (the “Certificate of Incorporation”), to effect up to two reverse stock splits of our common stock having

an aggregate ratio in the range of 1-for-2 to 1-for-199 over a period of two years, with such reverse stock splits to be effected

at such ratios, times and dates, if at all, as determined by the Board in its sole discretion, (ii) an amendment to our Certificate

of Incorporation to increase the number of our authorized shares of common stock from 250,000,000 shares to 500,000,000 and to make

a corresponding change to the number of authorized shares of capital stock and (iii) our 2025 Equity Incentive Plan.

August 6, 2025, we filed a Certificate of Amendment to our Certificate of Incorporation with the Secretary of State of the State

of Delaware to increase the number of authorized shares of common stock from 250,000,000 shares to 500,000,000 shares.

The Certificate

of Amendment was approved by the Company’s stockholders at the annual meeting on June 23, 2025 and became effective upon filing.

August 15, 2025, we entered into Warrant Exchange Agreements (the “Exchange Agreements”) with certain holders (the “Exchanging

Holders”) of April 2024 Warrants to purchase an aggregate of 466,666 shares of common stock.

Pursuant to the Exchange Agreements,

on August 15, 2025, the Company issued to the Exchanging Holders one share of common stock for each April 2024 Warrant, for an aggregate

of 466,666 shares of common stock.

lead drug candidate based on the LNC Platform is MAT2203, an oral formulation of amphotericin B, a well-known and highly effective antifungal

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for longer periods of time and more broadly than amphotericin B has ever have been used previously and in an outpatient setting.

has been developed to date with the assistance and financial support of the National Institutes of Allergy and Infectious Disease (NIAID)

has been developed to date with the assistance and financial support of the National Institutes of Allergy and Infectious Diseases (NIAID)

of the National Institutes of Health (NIH).

MAT2203 has been designated as a Qualified Infectious Disease Product (QIDP) with Fast Track

Status for the treatment of invasive candidiasis, the treatment of aspergillosis, the prevention of IFIs in patients who are on immunosuppressive

therapy, and, most recently with an Orphan Designation for the treatment of cryptococcosis.

We believe that it is possible to pursue

additional orphan designations for the treatment of aspergillosis, the treatment of invasive candidiasis and the treatment of certain

endemic mycoses.

Upon approval, MAT2203 could be eligible for up to 12 years of regulatory or marketing exclusivity in the United States.

Status for the treatment of invasive candidiasis, the treatment of aspergillosis, the prevention of invasive fungal infections, or IFIs,

in patients who are on immunosuppressive therapy, and, most recently with an Orphan Designation for the treatment of cryptococcosis.

We believe that it is possible to pursue additional orphan designations for the treatment of aspergillosis, the treatment of invasive

candidiasis and the treatment of certain endemic mycoses.

Upon approval, MAT2203 could be eligible for up to 12 years of regulatory or

marketing exclusivity in the United States.

initial planned indication for MAT2203 is early step-down therapy from IV amphotericin B for the treatment of invasive aspergillosis

in patient with limited treatment options.

in patients with limited treatment options.

Invasive aspergillosis is a serious and life-threatening invasive fungal infection that occurs

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indication is a gateway indication, as we believe that a partner could expand the utilization of MAT2203 into the treatment of other

invasive fungal infections (IFIs) and potentially even for prophylaxis against IFIs in immunocompromised patients, such as transplant

IFIs and potentially even for prophylaxis against IFIs in immunocompromised patients, such as transplant patients.

EnACT ( Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial ) Phase 2 study was a Phase 2 prospective, randomized,

open-label, sequential cohort study, financially supported by the NIH NINDS, evaluating the safety, tolerability, and efficacy of MAT2203

in 100 HIV-positive persons with cryptococcal meningitis.

The EnACT trial included a total of four cohorts of patients, with the first

two cohorts testing MAT2203 as early step-down therapy following initial treatment with IV amphotericin B during the 14-day induction

period, and the second two cohorts testing MAT2203 as potentially all oral therapy.

The induction period for all patients in each cohort

(active or control) is 14 days, followed by an additional four weeks of treatment (active or control) during a consolidation/maintenance

open-label, sequential cohort study, financially supported by the NIH, evaluating the safety, tolerability, and efficacy of MAT2203 in

100 HIV-positive persons with cryptococcal meningitis.

The EnACT trial included a total of four cohorts of patients, with the first two

cohorts testing MAT2203 as early step-down therapy following initial treatment with IV amphotericin B during the induction period, and

the second two cohorts testing MAT2203 as potentially all oral therapy.

The induction period for all patients in each cohort (active

or control) is 14 days, followed by an additional four weeks of treatment (active or control) during a consolidation/maintenance period.

Cohorts 1 and 3 were safety lead-ins to Cohorts 2 and 4, respectively, which were the key efficacy cohorts for EnACT.

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through 10 weeks.

In Cohort 2, overall survival was 90% after 18 weeks in 40 patients randomized to receive MAT2203.

In Cohort 2, the secondary endpoint of overall survival was 90% after 18 weeks in 40 patients randomized to receive

data from Cohort 4 of the Phase 2 EnACT study of MAT2203 (oral amphotericin B) for the treatment of cryptococcal meningitis (CM) were

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remained at 90% through 18 weeks, while the survival rate at Week 2 was 95%.

Importantly, the incidence of adverse events relating to kidney function and anemia were significantly

lower for MAT2203 compared to the conventional IV amphotericin B standard of care treatment across the entirety of the EnACT trial, with

no evidence of kidney toxicity even with up to 6 weeks of oral MAT2203 treatment.

February 2024, we announced agreement with the United States Food and Drug Administration (FDA) on the design of a single Phase 3 registration

trial of MAT2203 in patients with invasive aspergillosis who have limited treatment options, including consensus on all critical elements

of the ORALTO trial.

In its correspondence, FDA agreed that the ORALTO trial would potentially be sufficient to support

the registration of MAT2203 for an initial indication for the treatment of invasive aspergillosis in patients with limited treatment options,

when and if conducted.

Approval would be subject to normal FDA review of all aspects of this clinical trial.

Importantly, the incidence of adverse events relating to

kidney function and anemia were significantly lower for MAT2203 compared to the conventional IV amphotericin B standard of care treatment

across the entirety of the EnACT trial, with no evidence of kidney toxicity even with up to 6 weeks of oral MAT2203 treatment.

February 2024, we announced agreement with the FDA on the design of a single Phase 3 registration trial of MAT2203 in patients with invasive

aspergillosis who have limited treatment options, including consensus on all critical elements of the ORALTO trial.

In its correspondence,

FDA agreed that the ORALTO trial would potentially be sufficient to support the registration of MAT2203 for an initial indication for

the treatment of invasive aspergillosis in patients with limited treatment options, when and if conducted.

Approval would be subject

to normal FDA review of all aspects of this clinical trial.

is planned to be a Phase 3, randomized, multicenter, open-label, adjudicator-blinded study to evaluate the efficacy and safety of MAT2203

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of the impact of MAT2203 on healthcare resource utilization and quality of life impact.

has been planned to include approximately 216 adults with recently diagnosed probable or proven invasive aspergillosis who are being

was been planned to include approximately 216 adults with recently diagnosed probable or proven invasive aspergillosis who are being

treated with AmBisome due to their inability to receive an IV mold-active azole and with limited alternative treatment options.

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development program and pathway for MAT2203.

There can be no assurance that the Company will be successful in consummating a transaction

involving MAT2203.

There can be no assurance that we will be successful in consummating a transaction involving

addition to conducting the EnACT trial, a MAT2203 Compassionate/Expanded Use Access Program was established to provide MAT2203 on a compassionate

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The majority of enrolled patients are post-transplant or are undergoing treatment for underlying malignancies.

patients have been treated for invasive asperillosis, each with positive results.

The infections being treated with MAT2203 include a

variety of micro-organisms (including Aspergillus , Mucorales species , Candidiasis , Fusarium and suspected

patients have been treated for invasive aspergillosis, each with positive results.

The infections being treated with MAT2203 include

a variety of micro-organisms (including Aspergillus , Mucorales species , Candidiasis , Fusarium and suspected

Coccidioides ) occurring at multiple sites of infection, including brain, bladder/colon, bone, lung, sinus, and skin.

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to MAT2203 therapy and suffered no further renal side effects over the course of extended treatment with MAT2203.

have been focused on redefining the intracellular delivery of nucleic acids and small molecules through our LNC Platform and its application

While we have temporarily

suspended the availability of MAT2203 under this program, we continue to monitor patients and provide ongoing support through external

clinical medical consultants.

had been focused on redefining the intracellular delivery of nucleic acids and small molecules through our LNC Platform and its application

to overcome current challenges in safely and effectively delivering small molecules, nucleic acids, gene therapies, proteins/peptides,

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elements of our strategy now include:

one or more partners to monetize the value of MAT2203 and raising additional non-dilutive capital through the licensing

or sale of our lead LNC Platform product candidate.

A partnership, whether through a license, sale or other transaction, would likely seek to advance MAT2203 into Phase 3 development as

quickly as possible, which could position a partner to commercialize MAT2203 upon approval and which could bring additional longer-term

value to the Company and its shareholders.

one or more partners to monetize the value of MAT2203 and raising additional non-dilutive capital through the licensing or sale of

our lead LNC Platform product candidate.

A partnership, whether through a license, sale or other transaction, would likely seek to

advance MAT2203 into Phase 3 development as quickly as possible, which could position a partner to commercialize MAT2203 upon approval.

our cash resources while identifying and evaluating other strategic options for the Company, which could include the in-licensing

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candidiasis and aspergillosis, for the prevention of IFIs in patients on immunosuppressive therapy, and the treatment of cryptococcosis.

We recently also received Orphan Drug Designation for MAT2203 for the treatment of cryptococcosis and associated CM from the U.S.

The FDA may designate a product candidate as an orphan drug if it is intended to treat a rare disease or condition, which is

generally defined as having a patient population of fewer than 200,000 individuals in the United States, or a patient population greater

than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from

sales in the United States.

The orphan drug designation provides eligibility for orphan drug exclusivity in the United States upon FDA

approval if a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient

for the disease for which it has such designation.

For a product that obtains orphan drug designation based on a plausible hypothesis

that it is clinically superior to the same drug that is already approved for the same indication, to obtain orphan drug exclusivity upon

approval, clinical superiority of such product to this same drug that is already approved for the same orphan indication must be demonstrated.

Orphan drug exclusivity means that the FDA may not approve any other applications, including a NDA, to market the same drug for the same

indication for seven years, except in limited circumstances such as if the FDA finds that the holder of the orphan drug exclusivity has

not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease

or condition for which the drug was designated.

Similarly, the FDA can subsequently approve a drug with the same active moiety for the

same condition during the exclusivity period if the FDA concludes that the later drug is clinically superior, meaning the later drug

is safer, more effective or makes a major contribution to patient care.

Orphan drug designation also entitles a party to financial incentives

such as opportunities for grant funding towards clinical trial costs, a waiver from payment of user fees, an exemption from performing

clinical studies in pediatric patients unless the FDA requires otherwise by regulation, and tax credits for the cost of the clinical

We recently also received Orphan Drug Designation for MAT2203 for the treatment of cryptococcosis and associated (CM) from the FDA and

the European Medicines Agency (the “EMA”).

The FDA may designate a product candidate as an orphan drug if it is intended

to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individuals in

the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the

cost of developing the drug will be recovered from sales in the United States.

The orphan drug designation provides eligibility for orphan

drug exclusivity in the United States upon FDA approval if a product that has orphan drug designation subsequently receives the first

FDA approval for a particular active ingredient for the disease for which it has such designation.

For a product that obtains orphan

drug designation based on a plausible hypothesis that it is clinically superior to the same drug that is already approved for the same

indication, to obtain orphan drug exclusivity upon approval, clinical superiority of such product to this same drug that is already approved

for the same orphan indication must be demonstrated.

Orphan drug exclusivity means that the FDA may not approve any other applications,

including a NDA, to market the same drug for the same indication for seven years, except in limited circumstances such as if the FDA

finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the

orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.

Similarly, the FDA can subsequently

approve a drug with the same active moiety for the same condition during the exclusivity period if the FDA concludes that the later drug

is clinically superior, meaning the later drug is safer, more effective or makes a major contribution to patient care.

Orphan drug designation

also entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, a waiver from payment

of user fees, an exemption from performing clinical studies in pediatric patients unless the FDA requires otherwise by regulation, and

tax credits for the cost of the clinical research.

QIDP designation, provided under the Generating Antibiotic Incentives Now Act, or the GAIN Act, offers certain incentives for the development

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overall global antifungal market was valued at approximately $15.8 billion in 2023 and is expected to reach approximately $20.5 billion

In 2021, the global invasive fungal infection market was valued at more than $7.2 billion and is expected to reach $10.4

billion in 2030.

This includes therapies used as active treatment or prophylaxis (preventative) in the inpatient and outpatient setting,

therapies used for the treatment of hospitalized patients and therapies used for the treatment of patients who are being discharged from

the hospital.

Importantly, private insurance costs per visit range from approximately $40k to $150K per patient (2019 Benedict) mostly

due to extended length of stay.

We estimate that, each year, there are over 1.5 million cases of IFIs caused by various species of Candida,

Aspergillus and Cryptococcus, the three most common invasive fungal pathogens, globally.

In 2021, the global invasive fungal infection market was valued at more than $7.2 billion and is expected to reach $10.4 billion

This includes therapies used as active treatment or prophylaxis (preventative) in the inpatient and outpatient setting, therapies

used for the treatment of hospitalized patients and therapies used for the treatment of patients who are being discharged from the hospital.

Importantly, private insurance costs per visit range from approximately $40k to $150K per patient (2019 Benedict) mostly due to extended

length of stay.

We estimate that, each year, there are over 1.5 million cases of IFIs caused by various species of Candida, Aspergillus

and Cryptococcus, the three most common invasive fungal pathogens, globally.

The estimated incidence in the U.S.

for these conditions is approximately 46,000 for invasive candidiasis, 15,000 for invasive aspergillosis, and 4,900 for CM.

aspergillosis-associated hospitalizations in the U.S.

alone came at an estimated treatment cost of more than $1.3 billion, with indirect

costs amounting to an additional $485 million.

The rapid progression of disease and high mortality rates (20% - 50%) associated with

documented IFIs often result in antifungal therapy being administered in suspected (unconfirmed) cases or as a preventative measure in

patients at high risk.

Also, the increasingly widespread use of immune suppressive drugs as cancer chemotherapy or for organ transplantation

or treatment of autoimmune disease has resulted in an increasing population of patients at risk for IFIs.

Furthermore, the limited number

of systemic antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their extensive use, has led to increased

numbers of infections with drug-resistant strains.

The Centers for Disease Control and Prevention (“CDC”) has listed fluconazole-resistant

Candida as a serious threat requiring prompt and sustained action and has also identified a rise in echinocandin resistance, especially

among Candida glabrata.

In 2022, the World Health Organization issued a fungal priority pathogens list including cryptococcal

neoformans, aspergillus fumigatus and c.

albicans as critical priority for antifungal development due to the high unmet

We believe this underscores the urgent need for new agents with demonstrated activity against resistant strains and that can be

administered with significantly less toxicity and the potential to discharge patients earlier to reduce hospital stays and associated

conditions is approximately 46,000 for invasive candidiasis, 15,000 for invasive aspergillosis, and 4,900 for CM.

For example, aspergillosis-associated

hospitalizations in the U.S.

alone came at an estimated treatment cost of more than $1.3 billion, with indirect costs amounting to an

additional $485 million.

The rapid progression of disease and high mortality rates (20% - 50%) associated with documented IFIs often

result in antifungal therapy being administered in suspected (unconfirmed) cases or as a preventative measure in patients at high risk.

Also, the increasingly widespread use of immune suppressive drugs as cancer chemotherapy or for organ transplantation or treatment of

autoimmune disease has resulted in an increasing population of patients at risk for IFIs.

Furthermore, the limited number of systemic

antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their extensive use, has led to increased numbers of infections

with drug-resistant strains.

The Centers for Disease Control and Prevention (“CDC”) has listed fluconazole-resistant Candida

as a serious threat requiring prompt and sustained action and has also identified a rise in echinocandin resistance, especially among

Candida glabrata.

In 2022, the World Health Organization issued a fungal priority pathogens list including cryptococcal neoformans,

aspergillus fumigatus and c.

albicans as critical priority for antifungal development due to the high unmet need.

this underscores the urgent need for new agents with demonstrated activity against resistant strains and that can be administered with

significantly less toxicity and the potential to discharge patients earlier to reduce hospital stays and associated costs.

License Agreement with Rutgers University

our acquisition of Aquarius Biotechnologies Inc., we acquired a license from Rutgers for certain patents related to the LNC Platform.

our acquisition of Aquarius Biotechnologies Inc., we acquired a license from Rutgers University (“Rutgers”) for certain patents

related to the LNC Platform.

We subsequently changed the name of Aquarius Biotechnologies Inc.

to Matinas BioPharma Nanotechnologies, Inc.

and in February of 2022,

the parties agreed to a Second Amended and Restated Exclusive License Agreement.

The agreement provides for (1) royalties on a tiered

basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales

milestone fee of $100,000 when and if sales of products using the licensed technology reach the specified sales threshold and (3) an

annual license fee of $50,000 over the term of the license agreement.

There was also a reduction in the consideration paid to Rutgers

in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to the Agreement.

In consideration of the

concessions made by Rutgers in the amended license agreement, the Company issued Rutgers 400,000 shares of common stock in February 2022.

to Matinas BioPharma Nanotechnologies,

Inc., and in February of 2022, the parties agreed to a Second Amended and Restated Exclusive License Agreement.

The agreement provides

for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed

technology, (2) a one-time sales milestone fee of $100,000 when and if sales of products using the licensed technology reach the specified

sales threshold and (3) an annual license fee of $50,000 over the term of the license agreement.

There was also a reduction in the consideration

paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to the Agreement.

In consideration

of the concessions made by Rutgers in the amended license agreement, the Company issued Rutgers 400,000 shares of common stock in February

We also agreed to continue to assume the responsibility to pay required patent prosecution and maintenance fees covering the technology.

otherwise terminated by either party, the term of the license, on a country-by-country basis, shall be the longer of 8-1/2 years

from the date of first commercial sale of a product in a country using the licensed technology or until the expiration of the

last-to-expire patent rights licensed under the agreement, whichever is longer.

Rutgers has the right to terminate the license

agreement if we have not commenced commercial sales of at least one product using the licensed technology within eight years of the

effective date of the Second Amended and Restated License Agreement.

We have discussed the elimination of this termination right

with Rutgers through an amendment to the license agreement while we seek a partner for MAT2203.

otherwise terminated by either party, the term of the license, on a country-by-country basis, shall be the longer of 8-1/2 years from

the date of first commercial sale of a product in a country using the licensed technology or until the expiration of the last-to-expire

patent rights licensed under the agreement, whichever is longer.

Rutgers has the right to terminate the license agreement if we have

not commenced commercial sales of at least one product using the licensed technology within eight years of the effective date of the

Second Amended and Restated License Agreement.

We have discussed the elimination of this termination right with Rutgers through an amendment

to the license agreement while we seek a partner for MAT2203.

proprietary nature of, and protection for, our product candidates and our discovery programs, processes and know-how are important to

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Pursuant to our license

agreement, we acquired rights to a portfolio that as of March 31, 2025 included 1 pending U.S.

agreement, we acquired rights to a portfolio that as of January 31, 2026 included 1 pending U.S.

non-provisional patent application,

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Matinas-owned patent portfolio covers our LNC Platform and users.

As of March 31, 2025, this patent portfolio includes 5 pending U.S.

provisional applications, 2 pending U.S.

non-provisional applications, 2 pending PCT applications, 13 pending foreign applications, and

20 granted foreign patents.

The foreign pending applications and granted patents are in countries including Europe, China, Brazil, Canada,

Japan, Korea, Australia and Mexico

of March 31, 2025, we owned one issued U.S.

patent, 7 issued foreign patents in Australia, Canada, Europe, and Japan, and one pending

foreign patent application in Korea, directed to compositions and methods for enhancing tissue penetration of an active agent in an LNC.

The patents are expected to expire in 2036, and patents issuing from or claiming priority to the pending application are also expected

to expire in 2036, excluding patent term adjustments or extensions.

of March 31, 2025, we owned 9 foreign patents in Australia, Europe, and Japan, directed to LNC compositions and methods for treating

mycobacteria infection.

As of January 31, 2026, this patent portfolio includes 1 U.S.

3 pending U.S.

non-provisional applications, 10 pending foreign applications, and 19 granted foreign patents.

The foreign pending applications

and granted patents are in countries including Europe, China, Brazil, Canada, Japan, Korea, Australia and Mexico

of January 31, 2026, we owned one issued U.S.

patent, and 7 issued foreign patents in Australia, Canada, Europe, and Japan, directed

to compositions and methods for enhancing tissue penetration of an active agent in an LNC.

The patents are expected to expire in 2036,

and patents issuing from or claiming priority to the pending application are also expected to expire in 2036, excluding patent term adjustments

or extensions.

of January 31, 2026, we owned 9 issued foreign patents in Australia, Europe, and Japan, directed to LNC compositions and methods for

treating mycobacteria infection.

The patents are expected to expire in 2036, excluding patent term adjustments or extensions.

of March 31, 2025, we owned one U.S.

of January 31, 2026, we owned one U.S.

issued patent, one pending non-provisional U.S.

patent application, 2 issued foreign patents in

Japan and Australia, and 4 pending applications in China, Korea, Canada, and Europe, directed to LNC compositions and methods for treating

cryptococcus infections.

The patents are expected to expire in 2037, and patents issuing from or claiming priority to the pending application

are also expected to expire in 2037, excluding patent term adjustments or extensions.

of March 31, 2025, we owned one pending non-provisional U.S.

Japan and Australia, and 3 pending applications in China, Canada, and Europe, directed to LNC compositions and methods for treating cryptococcus

The patents are expected to expire in 2037, and patents issuing from or claiming priority to the pending application are

also expected to expire in 2037, excluding patent term adjustments or extensions.

of January 31, 2026, we owned one pending non-provisional U.S.

patent application, and 6 pending applications in Australia, Brazil, Canada,

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from or claiming priority to the pending applications are also expected to expire in 2040, excluding patent term adjustments or extensions.

of March 31, 2025, we owned one PCT application directed to methods for controlling LNC particle size.

Patents issuing from or claiming

priority to the pending applications are also expected to expire in 2043, excluding patent term adjustments or extensions.

of March 31, 2025, we owned one PCT application directed to LNC compositions and methods for treating mucormycosis.

Patents issuing

from or claiming priority to the pending applications are also expected to expire in 2043, excluding patent term adjustments or extensions.

of January 31, 2026, we owned one pending non-provisional U.S.

patent application and one pending application in Europe directed to LNC

compositions and methods for treating mucormycosis.

Patents issuing from or claiming priority to the pending applications are also expected

to expire in 2043, excluding patent term adjustments or extensions.

cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications

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manufacturers, academic institutions, governmental agencies, and public and private research institutions.

if approved by FDA, will primarily compete with antifungal classes approved for the treatment of fungal and mold infections, which

include polyenes, azoles and echinocandins.

The approved branded therapies for these indications include Cancidas (caspofungin, marketed

by Merck & Co.), Eraxis (anidulafungin, marketed by Pfizer, Inc.), Mycamine (micafungin, marketed by Astellas Pharma US, Inc.), Diflucan

(fluconazole, marketed by Pfizer, Inc.), Noxafil (posaconazole, marketed by Merck & Co.), Vfend (voriconazole, marketed by Pfizer,

Inc.), Sporanox (itraconazole, marketed by Jansen Pharmaceuticals, Inc.), Cresemba (isavuconazole, marketed by Astellas Pharma US, Inc.),

Ambisome (liposomal amphotericin B, marketed by Astellas Pharma US, Inc.), Abelcet (lipid complex amphotericin B, marketed by Sigma Tau

Pharmaceuticals Inc.), Rezzayo (rezafungin, marketed by Melinta Therapeutics), Brexafemme (Ibrexafungerp marketed by GlaxoSmithKline)

and amphotericin B deoxycholate (marketed by X-Gen Pharmaceuticals, Inc.).

There currently are and may be more generic versions of these

products available at the time of MAT2203 market approval, which will create added competition.

In addition to approved therapies, we

expect that MAT2203 may compete with product candidates that we are aware of in clinical development by third parties, such olorofim

(being developed by F2G, Ltd), fosmanogepix (being developed by Basilea), and AM2-19, a derivative of amphotericin B being developed

by Elion Therapeutics.

if approved by FDA, will primarily compete with antifungal classes approved for the treatment of fungal and mold infections, which include

polyenes, azoles and echinocandins.

The approved branded therapies for these indications include Cancidas (caspofungin, marketed by Merck

& Co.), Eraxis (anidulafungin, marketed by Pfizer, Inc.), Mycamine (micafungin, marketed by Astellas Pharma US, Inc.), Diflucan (fluconazole,

marketed by Pfizer, Inc.), Noxafil (posaconazole, marketed by Merck & Co.), Vfend (voriconazole, marketed by Pfizer, Inc.), Sporanox

(itraconazole, marketed by Jansen Pharmaceuticals, Inc.), Cresemba (isavuconazole, marketed by Astellas Pharma US, Inc.), Ambisome (liposomal

amphotericin B, marketed by Astellas Pharma US, Inc.), Abelcet (lipid complex amphotericin B, marketed by Leadiant Biosciences), Rezzayo

(rezafungin, marketed byCorMedix Therapeutics), Brexafemme (Ibrexafungerp marketed by GlaxoSmithKline) and amphotericin B deoxycholate

(marketed by X-Gen Pharmaceuticals, Inc.).

There currently are and may be more generic versions of these products available at the time

of MAT2203 market approval, which will create added competition.

In addition to approved therapies, we expect that MAT2203 may compete

with product candidates that we are aware of in clinical development by third parties, such olorofim (being developed by F2G, Ltd), fosmanogepix

(being developed by Basilea), and EL219, a derivative of amphotericin B being developed by Elion Therapeutics.

Manufacturing

currently lease in-house manufacturing capabilities for our lead LNC Platform product candidate, MAT2203.

While sufficient to produce

the clinical supplies of product necessary to conduct our previous clinical trials with MAT2203, we continue to explore relationships

with well-respected third-party contract manufacturers for the formulation and manufacture of MAT2203, which would be necessary should

we be successful in finding a partner to continue the development of MAT2203.

We would be required to transfer our technology and any

associated information to our partner or to a third-party manufacturer in order to manufacture the drug necessary for additional clinical

work and any supplies required for the commercialization of MAT2203, if approved.

However, following our reduction

in force in October 2024, we no longer produce MAT2203 or any other clinical trial material at this facility.

We are currently searching

for a partner to takeover development of MAT2203 and this partner will be required to identify and secure one or more third-party contract

manufacturers for the formulation and manufacture of MAT2203.

As part of any partnership, a transfer of our manufacturing technology

and any associated information to our partner or to a third-party manufacturer would be required in order to manufacture the drug necessary

for additional clinical work and any supplies required for the commercialization of MAT2203, if approved.

are several potential third-party suppliers for amphotericin B, the generic active pharmaceutical ingredient in our lead clinical stage

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trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in

accordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed

consent in writing before their participation in any clinical trial.

Clinical trials are conducted under written study protocols detailing,

among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be

A protocol for each clinical trial and any subsequent protocol amendments must be submitted to FDA as part of the IND.

IND automatically becomes effective 30 days after receipt by FDA, unless before that time FDA raises concerns or questions related to

a proposed clinical trial and places the trial on clinical hold.

In such a case, the IND sponsor and FDA must resolve any outstanding

concerns before the clinical trial can begin.

Accordingly, submission of an IND may or may not result in FDA allowing clinical trials

addition, an IRB representing each institution participating in the clinical trial must review and approve the plan for any clinical

trial before it commences at that institution, and the IRB must conduct continuing review and reapprove the study at least annually.

The IRB must review and approve, among other things, the study protocol and informed consent information to be provided to study subjects.

accordance with Good Clinical Practice, or GCP, requirements, which include, among other things, the requirement that all research subjects

provide their informed consent in writing before their participation in any clinical trial.

Clinical trials are conducted under written

study protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness

criteria to be evaluated.

A protocol for each clinical trial and any subsequent protocol amendments must be submitted to FDA as part

of the Investigational New Drug application, or IND.

An IND automatically becomes effective 30 days after receipt by FDA, unless before

that time FDA raises concerns or questions related to a proposed clinical trial and places the trial on clinical hold.

In such a case,

the IND sponsor and FDA must resolve any outstanding concerns before the clinical trial can begin.

Accordingly, submission of an IND

may or may not result in FDA allowing clinical trials to commence.

addition, an Institutional Review Board, or IRB, representing each institution participating in the clinical trial must review and approve

the plan for any clinical trial before it commences at that institution, and the IRB must conduct continuing review and reapprove the

study at least annually.

The IRB must review and approve, among other things, the study protocol and informed consent information to

be provided to study subjects.

An IRB must operate in compliance with FDA regulations.

Information about certain clinical trials must be submitted within specific timeframes

to the National Institutes of Health for public dissemination on their ClinicalTrials.gov website.

Information about certain clinical trials must

be submitted within specific timeframes to the National Institutes of Health for public dissemination on their ClinicalTrials.gov website.

sponsor who wishes to conduct a clinical trial outside the United States may, but need not, obtain FDA authorization to conduct the clinical

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overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.

reports detailing the results of the clinical trials must be submitted at least annually to FDA and more frequently if serious AEs occur.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all.

Furthermore, FDA

or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects

are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution,

or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the

drug has been associated with unexpected serious harm to patients.

FDA will typically inspect one or more clinical sites to assure compliance

with GCP and the integrity of the clinical data submitted.

reports detailing the results of the clinical trials must be submitted at least annually to FDA and more frequently if serious Adverse

Events, or AEs, occur.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or

Furthermore, FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding

that the research subjects are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a

clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the

IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

FDA will typically inspect one

or more clinical sites to assure compliance with GCP and the integrity of the clinical data submitted.

of an NDA to FDA

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broader than what was designated in its orphan product application, it may not be entitled to exclusivity.

Century Cures Act

21 st Century Cures Act, or the Cures Act is designed to modernize and personalize healthcare, spur innovation and research,

and streamline the discovery and development of new therapies through increased federal funding of particular programs.

It authorizes

increased funding for the FDA to spend on innovation projects.

The Cures Act establishes the NIH Innovation Fund to pay for the cost

of development and implementation of a strategic plan, early-stage investigators and research.

It also charges NIH with leading and coordinating

expanded pediatric research.

In addition, the Cures Act includes provisions requiring the FDA to assess and publish guidance on the use

of novel clinical trial designs, the use of real-world evidence in applications, the availability of summary level review for supplemental

applications for certain indications, and the qualification of drug development tools.

Because the Cures Act has only recently been enacted,

its potential effect on our business remains unclear with the exception of a provision requiring that we post our policies on the availability

of expanded access programs for individuals.

Because these provisions allow the FDA to spend several years developing these policies,

the effect on us could be delayed.

amendments to the FDCA and the Public Health Service Act, or PHSA, Title III of the Cures Act seeks to accelerate the discovery, development,

and delivery of new medicines and medical technologies.

To that end, and among other provisions, the Cures Act reauthorizes the existing

priority review voucher program for certain drugs intended to treat rare pediatric diseases until 2026;

creates a new priority review

voucher program for drug applications determined to be material national security threat medical countermeasure applications;

the FDCA to streamline review of combination product applications.

3042 of the Cures Act authorizes a “Limited Population Pathway” to expedite approval of antimicrobial products intended to

treat serious or life-threatening infections for which there are unmet medical needs.

Drugs approved under this provision are required

to adhere to special labeling requirements, including a prominent “Limited Population” statement.

We will monitor the implementation

of the Cures Act but cannot currently assess how this initiative may impact our business.

Health Care Regulations

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that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional.

the centralized procedure, the Committee for Medicinal Products for Human Use, or the CHMP, established at the European Medicines Agency,

or EMA, is responsible for conducting the initial assessment of a drug.

The CHMP is also responsible for several post-authorization and

maintenance activities, such as the assessment of modifications or extensions to an existing marketing authorization.

Under the centralized

procedure in the European Union, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops, when additional

information or written or oral explanation is to be provided by the applicant in response to questions of the CHMP.

Accelerated evaluation

might be granted by the CHMP in exceptional cases when a medicinal product is of major interest from the point of view of public health

and in particular from the viewpoint of therapeutic innovation.

In this circumstance, the EMA ensures that the opinion of the CHMP is

given within 150 days.

the centralized procedure, the Committee for Medicinal Products for Human Use, or the CHMP, established at the EMA is responsible for

conducting the initial assessment of a drug.

The CHMP is also responsible for several post-authorization and maintenance activities,

such as the assessment of modifications or extensions to an existing marketing authorization.

Under the centralized procedure in the

European Union, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops, when additional information or

written or oral explanation is to be provided by the applicant in response to questions of the CHMP.

Accelerated evaluation might be

granted by the CHMP in exceptional cases when a medicinal product is of major interest from the point of view of public health and in

particular from the viewpoint of therapeutic innovation.

In this circumstance, the EMA ensures that the opinion of the CHMP is given

within 150 days.

decentralized procedure is available to applicants who wish to market a product in various European Union member states where such product

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preempted by HIPAA, thus complicating compliance efforts.

of March 31, 2025, we had three full time employees and retain the services of approximately 4 persons on an independent contractor/consultant

of March 31, 2026, we had two full time employees and retained the services of two independent contractors/consultants.

and Development

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expenses include cash and non-cash expenses relating to the development of our clinical and pre-clinical programs, including our anti-infective

product candidates, MAT2203 and MAT2501 as well as support and enhancement of our LNC Platform.

Our research and development expenses

reflect the reimbursement of certain MAT2501 program expenses of $0 and 88 thousand during the years ended December 31, 2024 and 2023,

respectively, related to the CFF grant agreement.

product candidates, MAT2203 as well as support and enhancement of our LNC Platform.

and Available Information

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Inc., a Delaware corporation originally formed on January 29, 2015 as Aquarius Biotechnologies, Inc.

principal executive offices are located at 1545 Route 206 South, Suite 302, Bedminster, New Jersey 07921, and our telephone number is

principal executive offices are located at 1545 Route 206 South, Suite 203A, Bedminster, New Jersey 07921, and our telephone number is

(908) 484-8805.

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make available on our website, free of charge, our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form

8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934,

as amended, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange

Commission, or the SEC.

Our SEC reports can be accessed through the Investors section of our internet website.

Further, a copy of this

Annual Report on Form 10-K is located at the SEC’s Public Reference Rooms at 100 F Street, N.E., Washington, D.

on the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330.

The SEC maintains a website that

contains reports, proxy and information statements and other information regarding our filings at http://www.sec.gov.

8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act, as soon

as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

Our SEC reports can be accessed

through the Investors section of our internet website.

Further, a copy of this Annual Report on Form 10-K is located at the SEC’s

Public Reference Rooms at 100 F Street, N.E., Washington, D.

Information on the operation of the Public Reference Room can

be obtained by calling the SEC at 1-800-SEC-0330.

The SEC maintains a website that contains reports, proxy and information statements

and other information regarding our filings at http://www.sec.gov.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business