Market Newsdesk

MELVILLE, N.Y., Nov. 20, 2020 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative” or the “Company”) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, announced today that its amended joint plan of reorganization has become effective and it has emerged from Chapter 11 reorganization. Pursuant to the confirmed plan of reorganization, the Company has received $3,848,000 in financing. The confirmed plan of reorganization also provides for additional funding, subject to certain conditions, of $3,500,000 less the sum of the debtor-in-possession financing provided to the Company during the reorganization (approximately $1,227,000) and the costs incurred by the debtor-in-possession lender.

In connection with the reorganization, Lance Alstodt has been appointed the Company’s President, Chief Executive Officer and Chairman of the Board. Mr. Alstodt said, “This process has been a long and challenging journey for the Company. I’m inspired by the great resolve and execution from our employees, professionals and investors. We are very pleased that all requirements have been met for us to emerge. Allowed creditor claims have been fully satisfied and, as importantly, our equity holders have retained their shares in this exciting new opportunity. We were able to preserve all of our intellectual property assets and look forward to initiating our Phase 2 clinical trial.”

Based upon the Company’s emergence from Chapter 11 reorganization, FINRA has removed the “Q” at the end of its trading symbol. Shareholders do not need to exchange their shares for new shares.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

• Metabolic Program (ThermoStem®): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains
“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provision
s of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in th
e forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company’s latest Form 10-
K filed
with the Securities and Exchange Commission. You should consider these factors in evaluatin
g the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:
Email: [email protected]

—

OLINVYK s
ignificantly reduced risk of vomiting and rescue antiemetic use
compared to IV morphine
in a retrospective analysis

—

CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled “Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials,” with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x).

The results of this analysis highlight an improved gastrointestinal (GI) tolerability profile, with OLINVYK demonstrating a ~2-3x likelihood of achieving a “complete GI response” compared to IV morphine under equianalgesic conditions. A complete GI response is defined as the proportion of patients who complete the study without vomiting and without using any antiemetics.

“There are multiple types of procedures where post-operative nausea or vomiting can disrupt the integrity of a surgery, posing a significant challenge to a patient’s recovery,” said Tim Beard, M.D. “Based on the results of this analysis, OLINVYK has the potential to greatly reduce the risk of nausea and vomiting following surgery, compared to IV morphine. These are compelling findings that suggest the clinical advantages OLINVYK may offer in the post-operative acute care setting.”

Publication Key Points:

• 
  O
  
  
  rthopedic
  
  
  surgery-bunionectomy study
  
  
  :
  A higher proportion of patients achieved ‘complete GI response’ with all OLINVYK treatment regimens (0.1 mg: 76.3%; 0.35 mg: 53.2%; 0.5 mg: 49.4%) compared to IV morphine (32.9%; p < 0.05 for all 3 OLINVYK dose regimens).
• 
  P
  
  
  lastic
  
  
  surgery-abdominoplasty study
  
  
  :
  A higher proportion of patients achieved ‘complete GI response’ with all OLINVYK treatment regimens (0.1 mg: 59.7%; 0.35 mg: 39.2%; 0.5 mg: 29.9%) compared to IV morphine (28.8%; p ≤ 0.0001 for OLINVYK 0.1 mg).
• 
  P
  
  
  ooled
  
  
  data from
  
  
  both
  
  
  trials
  
  
  :
  There was a statistically significantly higher rate of ‘complete GI response’ associated with OLINVYK 0.1 mg (68%) and 0.35 mg (46.2%) compared to IV morphine (30.8%; p ≤ 0.005).
• 
  Under equianalgesic conditions
  : Where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, patients were 3.1x more likely to achieve a ‘complete GI response’ with OLINVYK than IV morphine in the orthopedic surgery-bunionectomy study (95% CI: 1.78, 5.56; p <0.0001), and 1.9x more likely in the plastic-surgery abdominoplasty study (95% CI: 1.09, 3.36; p = 0.024).

About OLINVYK™ (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and single bolus doses greater than 3 mg have not been evaluated. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

For more information, please visit www.Trevena.com 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
(617) 430-7576

Company Contact:

Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840

MALVERN, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the online publication of a Network Meta-Analysis (NMA) for ANJESO (meloxicam) injection in the peer-reviewed medical journal BMC Anesthesiology. ANJESO was recently launched in the U.S. and is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

“The management of post-operative pain remains a significant issue, including providing adequate pain control beyond immediate postsurgical recovery,” said Jonathan Jahr, M.D., Professor Emeritus, Anesthesiology, University of California, Los Angeles School of Medicine. “Based on the results of multiple clinical trials, ANJESO (meloxicam) injection has been found to provide relief of moderate to severe acute pain, alone or in combination with other analgesics within the first 15 minutes after dosing and up to 24 hours after dosing compared to placebo. Specifically, ANJESO (meloxicam) injection provided superior pain relief for abdominoplasty, bunionectomy and hysterectomy when compared with acetaminophen, ibuprofen, and ketorolac, while also demonstrating a compelling profile with respect to reducing morphine consumption. Notably, ANJESO (meloxicam) injection was significantly more effective at reducing pain intensity than all comparators for those procedures in which pain intensity scores were recorded.”

“We believe that ANJESO offers an effective, non-opioid therapeutic option for the management of postsurgical pain for eligible patients,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. “As the only intravenous IV NSAID that lasts up to 24 hours, ANJESO has an equal or better safety profile than that of other IV non-opioids, and benefits patients by reducing their opioid consumption post-surgery. The results of this meta-analysis add to the growing body of data supporting our ongoing ANJESO commercial launch efforts.”

ANJESO
N
etwork
M
eta-
A
nalysis
Results

The published NMA results are based on the screening of over 2,300 studies, whereby 27 studies were identified and included in the analysis. Randomized clinical trials from 2000 to 2019 which involved at least one of the following procedures: open abdominal surgery, bunionectomy, open hysterectomy, orthopedic joint replacement surgery (including knee, ankle, hip, shoulder) were evaluated for inclusion. The literature search included publications that reported clinical effectiveness, safety and tolerability in adult patients receiving post-operative pain treatments. For this NMA, ANJESO was indirectly compared with only those IV treatments that were available at the time in the U.S., including acetaminophen, ibuprofen, and ketorolac. Studies for other non-opioid analgesics such as parecoxib and diclofenac were used for indirect comparison with the placebo arms in those studies.

The NMA found that among patients reporting moderate to severe postoperative pain, ANJESO was superior in pain reduction for abdominoplasty, bunionectomy and hysterectomy when compared with acetaminophen, ibuprofen, and ketorolac. In reducing morphine consumption, ANJESO was associated with significantly less morphine milligram equivalents (MME) utilization versus all comparators for abdominal procedures, hysterectomy, and versus acetaminophen in orthopedic procedures. Elsewhere MME utilization outcomes for ANJESO were largely equivalent or nominally better than other comparators.

The odds of opioid-related adverse events (ORADEs) were significantly higher for all comparators compared to ANJESO for orthopedic (gastrointestinal) and hysterectomy (respiratory). These results suggest ANJESO may provide better pain relief with a similar or better reduction in ORADEs compared to other approved IV NSAIDS.

About ANJESO®

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio’s first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential COX-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio’s ability to maintain regulatory approval for ANJESO, Baudax Bio’s ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio’s ability and that of Baudax Bio’s third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio’s ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio’s ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio’s estimates of the potential market for ANJESO, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]

Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected]

TULSA, Okla., Nov. 20, 2020 (GLOBE NEWSWIRE) — AAON, Inc. (NASDAQ: AAON), a leading manufacturer of heating and cooling products, announced that it has been named a 2020 Top Inclusive Workplace by Mosaic and the Tulsa Regional Chamber. Mosaic is the Tulsa Regional Chamber-led coalition of companies and nonprofit partners that celebrate diversity, champion equity and cultivate inclusion within the region’s business community. In order to qualify as a Top Inclusive Workplace, a company or organization must complete the Mosaic Index and report in the areas of CEO commitment, diverse suppliers, diverse people, internal policy and community outreach.

“AAON is honored to be named as a Top Inclusive Workplace in recognition of our commitment to diversity, equity and inclusion,” said Gary Fields, President and CEO of AAON. “We know that diversity and inclusion are key drivers for furthering innovation, productivity and team member engagement at AAON.”

AAON has two team member resource groups: AAON Veterans Empowering Through Service (V.E.T.S.) and the Women’s Alliance and Resource Program (WARP). AAON employs individuals from over 32 countries, and has a focus on promoting from within. On-site classes are available to help team members develop professionally and advance in the company such as: English as a Second Language, Spanish Language Classes, and Frontline Leadership Training for new and existing leaders.

About Mosaic

Mosaic is the Tulsa Regional Chamber-led coalition of companies and nonprofit partners that celebrate diversity, champion equity and cultivate inclusion within the region’s business community. Mosaic seeks to leverage the region’s diversity to improve perceptions of our community and grow the economy. Ultimately, Mosaic wishes to catapult the Tulsa region into the forefront of diversity and inclusion through talent recruitment initiatives and business retention and expansion efforts.

About AAON

AAON is engaged in the engineering, manufacturing, marketing, and sale of air conditioning and heating equipment consisting of standard, semi-custom, and custom rooftop units, chillers, packaged outdoor mechanical rooms, air handling units, condensing units, makeup air units, energy recovery units, geothermal/water-source heat pumps, coils, and controls. Since the founding of AAON in 1988, AAON has maintained a commitment to design, develop, manufacture and deliver heating and cooling products to perform beyond all expectations and demonstrate the value of AAON to our customers. For more information, please visit www.AAON.com.

Contact:
Stephanie Cameron
AAON, Inc.
918-688-9796
[email protected]

BEDMINSTER, N.J., Nov. 20, 2020 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care in areas of significant unmet medical need, today announced that it has been awarded up to $3.75 million from the Cystic Fibrosis Foundation (CFF). The award will support preclinical development of MAT2501, Matinas’ lipid nano-crystal (LNC) oral formulation of the broad-spectrum aminoglycoside amikacin, toward an indication to treat nontuberculous mycobacterial (NTM) lung disease, including infections in patients with cystic fibrosis (CF).

“We are grateful to the Cystic Fibrosis Foundation for their support in accelerating the development of MAT2501 as a potential best in class treatment for NTM lung disease. These are debilitating, potentially life-threatening, and increasingly prevalent pulmonary infections, especially in patients with cystic fibrosis,” commented Jerome D. Jabbour, Chief Executive Officer of Matinas. “We believe that an orally bioavailable amikacin, which takes advantage of our LNC delivery platform, would be the first oral aminoglycoside and would represent a significant improvement over currently available therapy. Furthermore, an oral, well tolerated, and targeted aminoglycoside would also potentially be of considerable value in treating other acute bacterial infections, especially gram-negative infections, where oral options are very limited and drug resistance is an increasing challenge. We look forward to continuing to work with the CF Foundation on realizing the potential of our LNC delivery platform.”   

The CFF award will allow Matinas to rapidly advance the development of MAT2501 and will support preclinical in vitro and in vivo studies, along with several of the toxicology studies necessary to progress MAT2501 into Phase 2. Pending a successful preclinical program, the CFF has indicated to Matinas a willingness to consider a request for further monetary support for the continuation of clinical studies, including dose determination and Phase 2 efficacy studies in CF patients suffering from NTM lung disease.  

MAT2501 has been designated as a Qualified Infectious Disease Product (QIDP) and as an Orphan Drug for the treatment of NTM by the U.S. Food and Drug Administration (FDA). Orphan Drug designation of MAT2501 provides for a seven-year marketing exclusivity period against competition in the United States upon FDA approval, as well as other incentives and exemptions, including waiver of Prescription Drug User Fee Act (PDUFA) filing fees and tax credits for the cost of the clinical research. If MAT2501 is ultimately approved by the FDA, the seven-year period of marketing exclusivity from orphan designation combined with the additional five years of marketing exclusivity provided by the QIDP designation, provides for a potential total of 12 years of marketing exclusivity.

About
N
TM
Lung Disease

NTM lung disease is a chronic, debilitating condition arising from an NTM infection in the lungs and is associated with significant patient morbidity and mortality. The signs and symptoms of NTM lung disease often overlap with the underlying lung conditions that increase risk for NTM, like cystic fibrosis, bronchiectasis, COPD, and asthma. The most common pathogens for NTM infections in the United States are Mycobacterium avium complex (MAC), which accounts for more than 80% of all NTM infections in the U.S. Patients with NTM lung infections frequently require lengthy hospital stays and prolonged courses of antibiotics to manage their disease.

The prevalence of human disease attributable to NTM has increased over the past two decades and is now growing at more than 8% per year and is even more prevalent than tuberculosis in the U.S. In 2018, it was estimated that between 75,000 and 100,000 patients were diagnosed with NTM lung disease in the U.S. alone.

About
MAT2501

MAT2501 is an oral, encochleated formulation of the broad-spectrum aminoglycoside antibiotic agent amikacin, which utilizes the Company’s proprietary LNC platform to achieve oral bioavailability, limit toxicity and enable targeted delivery to sites of infection. Currently, amikacin can only be delivered parenterally or through inhalation and is used to treat a variety of chronic and acute bacterial infections, including both NTM infections and various multidrug-resistant gram-negative bacterial infections. IV and inhaled amikacin, however, are associated with major side effects including nephrotoxicity and ototoxicity (permanent loss of hearing) with long-term use.  Matinas believes that MAT2501’s ability to orally deliver high levels of amikacin directly to the lung and without use-limiting toxicity, distinguishes it from all available therapies and could provide an important solution for patients and physicians.

About MatinasBioPharma

Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.

MAT9001, the Company’s lead product candidate for the treatment of cardiovascular and metabolic conditions, is a prescription-only omega-3 fatty acid-based composition, comprised primarily of EPA and DPA, under development for hypertriglyceridemia. MAT9001 is currently in a second head-to-head comparative study against Vascepa® (ENHANCE-IT), with topline data expected in the first quarter of 2021.

In addition, Matinas is developing a portfolio of products based upon its proprietary lipid nano-crystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them more targeted, less toxic and orally bioavailable.

MAT2203, the Company’s lead product candidate utilizing its LNC platform, is an oral, encochleated formulation of the well-known, but highly toxic, antifungal medicine amphotericin B, to treat serious invasive fungal infections. MAT2203 is currently in a Phase 2 open-label, sequential cohort study (EnACT) in HIV-infected patients with cryptococcal meningitis. EnACT will promptly begin enrolling patients in its second cohort, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.

Forward Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203 and MAT2501, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company’s ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as “expects,” “anticipates,” “intends,” “plans,” “could,” “believes,” “estimates” and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and the other factors listed under “Risk Factors” in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s product candidates are all in a development stage and are not available for sale or use.

Investor and Media Contacts

Peter Vozzo
Westwicke
443-213-0505
[email protected]

Ian Cooney
Director – Investor Relations & Corporate Development
Matinas Biopharma, Inc.
(415) 722-4563
[email protected]