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Matinas BioPharma(MTNB) - 2021 Q4 - Annual Report
2022-03-08 11:07
Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38022 MATINAS BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware No. 46-3011414 (State or other jurisdicti ...
Matinas BioPharma(MTNB) - 2021 Q3 - Earnings Call Transcript
2021-11-08 17:48
Matinas BioPharma Holdings, Inc. (NYSE:MTNB) Q3 2021 Earnings Conference Call November 8, 2021 8:30 AM ET Company Participants Peter Vozzo - Investor Relations Jerome Jabbour - Chief Executive Officer Keith Kucinski - Chief Financial Officer Terry Ferguson - Chief Medical Officer Terry Matkovits - Chief Development Officer Raphael Mannino - Chief Scientific Officer Conference Call Participants Robert Hazlett - BTIG Greg Fraser - Truist Operator Greetings and welcome to Matinas BioPharma's Third Quarter 2021 ...
Matinas BioPharma(MTNB) - 2021 Q3 - Quarterly Report
2021-11-08 11:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38022 MATINAS BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware No. 46-3011414 (State or other ...
Matinas BioPharma(MTNB) - 2021 Q2 - Earnings Call Transcript
2021-08-10 15:22
Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities at June 30, 2021, were approximately $59.8 million, compared to $58.7 million at December 31, 2020 [39] - Research and development expenses were approximately $2.5 million in Q2 2021, down from approximately $3.4 million in the same quarter of 2020, primarily due to the completion of the enhancement study of LYPDISO [40] - General and administrative expenses were approximately $2.3 million in Q2 2021, essentially unchanged from $2.4 million in the same period in 2020 [41] - The net loss attributable to common shareholders was approximately $5 million or $0.02 per share, compared to a net loss of $5.8 million or $0.03 per share in the same period of 2020 [41] - The company believes that cash on hand is sufficient to fund operations into 2024 [42] Business Line Data and Key Metrics Changes - The company is focusing on its Lipid Nanocrystal (LNC) Platform, which has shown potential for safe and effective intracellular drug delivery [10][12] - MAT2203, targeting HIV patients with cryptococcal meningitis, has completed enrollment for Cohort 2, with data expected to be discussed in September [16] - MAT2501, an oral formulation of amikacin, is set to enter a Phase 1 study in healthy volunteers in Q4 2021 [29] - The company has successfully formulated a potential oral version of Gilead's Remdesivir, with in vitro studies showing promising antiviral activity [31][34] Market Data and Key Metrics Changes - The company is addressing significant unmet medical needs in vulnerable patient populations, particularly with MAT2203 and MAT2501 [25][30] - The LNC Platform is positioned to transform the delivery of various therapeutic agents, including small molecules and complex biologics [14] Company Strategy and Development Direction - The company aims to validate its LNC Platform through ongoing clinical trials and collaborations with leading pharmaceutical companies [10][12] - There is a focus on obtaining regulatory approval for MAT2203 as a step-down therapy for cryptococcal meningitis, leveraging the unmet need in this area [25][63] - The company is exploring multiple regulatory pathways, including the Limited Population Pathway for anti-infective medicines [63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming data releases and the potential for significant milestones in the near term [43] - The company is confident in its ability to navigate regulatory discussions and expedite the development of its drug candidates [63][66] Other Important Information - The company has received positive feedback from the FDA regarding its development plans for MAT2501 [29] - The LNC Platform's ability to deliver drugs effectively across the blood-brain barrier is highlighted as a key advantage [18] Q&A Session Summary Question: Insights on MAT2501 and Remdesivir development timelines - Management indicated that MAT2501 will follow a streamlined regulatory process similar to MAT2203, with initial studies expected to begin by the end of next year [51][54] - For Remdesivir, in vivo studies are anticipated to start soon, with initial human data expected in the first half of 2022 [59] Question: Accelerated approval pathways for MAT2203 - Management discussed the potential for multiple regulatory pathways, including LPAD, and emphasized the importance of the data from Cohort 2 in discussions with the FDA [63][66] Question: Expectations for EnACT trial data - Management confirmed that survival data will be a key measure in both Cohort 1 and Cohort 2, with the design aimed at facilitating a step-down indication [71][73] Question: Number of patients in Cohort 2 and future milestones - Cohort 2 included 56 patients, with 40 on active treatment and 16 in the control group, and management expects to complete the EnACT trial in 2022 [82][85]
Matinas BioPharma(MTNB) - 2021 Q2 - Quarterly Report
2021-08-10 10:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 1545 Route 206 South, Suite 302 Bedminster, New Jersey 07921 (Address of principal executive offices) (Zip Code) 908-484-8805 (Registrant's telephone number, including area code) Securities registered ...
Matinas BioPharma(MTNB) - 2021 Q1 - Earnings Call Transcript
2021-05-10 16:21
Matinas BioPharma Holdings, Inc. (NYSE:MTNB) Q1 2021 Earnings Conference Call May 10, 2021 8:00 AM ET Company Participants Peter Vozzo - Investor Relations Jerome Jabbour - Chief Executive Officer Keith Kucinski - Chief Financial Officer Conference Call Participants Robert Hazlett - BTIG Yasmeen Rahimi - Piper Sandler Gregory Fraser - Truist Securities Operator Hello, and welcome to the Matinas BioPharma's Q1 2021 Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. ...
Matinas BioPharma(MTNB) - 2021 Q1 - Quarterly Report
2021-05-10 10:31
PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements for Q1 2021, encompassing balance sheets, statements of operations, stockholders' equity, and cash flows, accompanied by detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2021, total assets increased to **$72.4 million**, driven by cash and marketable securities, while total liabilities decreased to **$5.8 million**, resulting in increased stockholders' equity of **$66.6 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $23,382,743 | $12,432,481 | | Marketable securities | $37,283,697 | $46,246,573 | | Total current assets | $63,135,665 | $61,554,845 | | Total assets | $72,350,569 | $70,967,306 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $2,221,352 | $3,567,621 | | Total liabilities | $5,794,465 | $7,236,609 | | Total stockholders' equity | $66,556,104 | $63,730,697 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2021, the company reported a net loss of approximately **$5.0 million** or **($0.03) per share**, consistent with the prior year, with minimal revenue and total expenses of approximately **$6.4 million** Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Revenue | $33,333 | $ - | | Research and development expense | $3,241,432 | $4,086,883 | | General and administrative expense | $3,145,010 | $2,259,631 | | Loss from operations | $(6,353,109) | $(6,346,514) | | Net loss | $(4,956,320) | $(5,045,898) | | Net loss per share - basic and diluted | $(0.03) | $(0.03) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased from **$63.7 million** to **$66.6 million**, primarily due to **$5.6 million** net proceeds from a public stock offering and stock-based compensation, partially offset by net loss - During Q1 2021, the company issued **3,023,147 shares** of common stock in a public offering, raising net proceeds of **$5,580,471**[17](index=17&type=chunk) - Stock-based compensation expense for Q1 2021 was approximately **$1.1 million**[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flow](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flow) Net cash used in operating activities was approximately **$4.7 million**, while investing activities provided **$8.8 million** and financing activities provided **$6.8 million**, leading to a net cash increase of **$11.0 million** for Q1 2021 Condensed Consolidated Statements of Cash Flow (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,651,113) | $(4,664,546) | | Net cash provided by/(used in) investing activities | $8,816,859 | $(54,967,709) | | Net cash provided by financing activities | $6,784,516 | $47,439,344 | | Net increase/(decrease) in cash | $10,950,262 | $(12,192,911) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's status as a clinical-stage biopharmaceutical firm with an accumulated deficit of **$112.5 million**, but with **$60.7 million** in cash and marketable securities, sufficient to fund operations into 2024, alongside key collaborations and a **$5.6 million** stock offering - The company is a clinical-stage biopharmaceutical company focused on developing novel pharmaceutical products using its lipid nanocrystal (LNC) platform delivery technology[22](index=22&type=chunk)[24](index=24&type=chunk) - As of March 31, 2021, the company had cash and cash equivalents of **$23.4 million** and marketable securities of **$37.3 million**, which are believed to be sufficient to fund planned operations into **2024**[27](index=27&type=chunk) - The company entered into an award agreement with the Cystic Fibrosis Foundation (CFF) for up to **$4.2 million** to support the preclinical development of its MAT2501 product candidate, recognizing **$424,000** as credits to R&D expenses in Q1 2021[55](index=55&type=chunk)[56](index=56&type=chunk) - Under a feasibility study agreement with Genentech, the company recognized approximately **$33,000** of revenue in Q1 2021 for developing an oral formulation of a second molecule[57](index=57&type=chunk) - In Q1 2021, the company sold **3,023,147 shares** of common stock under its At-The-Market Sales Agreement, generating net proceeds of approximately **$5.6 million**[26](index=26&type=chunk)[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=19&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's LNC platform, clinical asset advancement, and financial performance for Q1 2021, reporting a **$5.0 million** net loss, with **$60.7 million** in cash and marketable securities expected to fund operations into 2024 - The company's strategy is focused on advancing its LNC platform technology, delivering efficacy data for MAT2203 in the EnACT study, progressing MAT2501 with support from the Cystic Fibrosis Foundation, and expanding collaborations[81](index=81&type=chunk)[84](index=84&type=chunk) - The company expects to continue incurring significant expenses and operating losses and will need additional financing, which it plans to seek through equity/debt offerings, collaborations, or other funding[82](index=82&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2021 revenue was minimal at **$33,000**, while R&D expenses decreased by **$0.9 million** to **$3.2 million** due to trial completion, and G&A expenses increased by **$0.8 million** to **$3.1 million** due to higher compensation Direct Research and Development Expenses (in thousands) | Expense Category | Three months ended March 31, 2021 | Three months ended March 31, 2020 | | :--- | :--- | :--- | | Manufacturing process development | $489 | $305 | | Preclinical trials | $9 | $151 | | Clinical development | $771 | $1,493 | | Regulatory | $42 | $19 | | Internal staffing, overhead and other | $1,930 | $2,119 | | **Total research and development** | **$3,241** | **$4,087** | - The decrease in R&D expenses was primarily due to the completion of the LYPDISO clinical trial in January 2021[100](index=100&type=chunk) - The increase in G&A expense was primarily due to higher compensation expense related to the exercise of stock options during the quarter[101](index=101&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company held approximately **$60.7 million** in cash and marketable securities, raising **$5.6 million** from ATM sales, with **$4.7 million** net cash used in operations, sufficient to fund operations into 2024 - As of March 31, 2021, the company had cash, cash equivalents and marketable securities totaling approximately **$60.7 million**[103](index=103&type=chunk) - In Q1 2021, the company sold **3,023,147 shares** of common stock under its ATM Sales Agreement, generating net proceeds of approximately **$5.6 million**[104](index=104&type=chunk) - The company expects its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditures requirements into **2024**[110](index=110&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Cash used in operating activities | $(4,651) | $(4,664) | | Cash provided by/(used in) investing activities | $8,817 | $(54,968) | | Cash provided by financing activities | $6,785 | $47,439 | [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company's market risk is primarily interest rate sensitivity on its **$60.7 million** cash and marketable securities, but due to the short-term nature of investments, no material impact from U.S. interest rate changes is anticipated - The company's primary market risk is interest income sensitivity from changes in U.S. interest rates on its cash, cash equivalents, and marketable securities[115](index=115&type=chunk) - Due to the short-term nature of the investment portfolio, a sudden change in market interest rates is not expected to have a material impact on financial condition or operations[115](index=115&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) As of March 31, 2021, disclosure controls and procedures were deemed effective, with modifications to internal controls over financial reporting resulting from the implementation of a new ERP system during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2021[116](index=116&type=chunk) - During the quarter ended March 31, 2021, the company implemented a **new ERP system**, which led to changes in its internal control over financial reporting[118](index=118&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) The company reported no legal proceedings during the reporting period - None[119](index=119&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20RISK%20FACTORS) No material changes were reported from the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 - There were **no material changes** from the risk factors set forth in the Annual Report on Form 10-K for the fiscal year ended December 31, 2020[120](index=120&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company reported no unregistered sales of equity securities or use of proceeds during the reporting period - None[121](index=121&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20OTHER%20INFORMATION) This item is not applicable for the current reporting period - Not applicable[124](index=124&type=chunk) [Exhibits](index=27&type=section&id=Item%206.%20EXHIBITS) This section refers to the Exhibit Index, listing all exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and XBRL data files - The Exhibit Index lists **certifications from the CEO and CFO (31.1, 31.2, 32.1)** and **XBRL-related documents (101.1-101.6)** filed with the report[125](index=125&type=chunk)[131](index=131&type=chunk)
Matinas BioPharma (MTNB) Investor Presentation - Slideshow
2021-04-15 23:28
MATINAS 1 BIOPHARMA Corporate Presentation April/May 2021 Forward-Looking Statement This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, cash flow 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 ar ...
Matinas BioPharma(MTNB) - 2020 Q4 - Earnings Call Transcript
2021-03-29 17:13
Matinas BioPharma Holdings, Inc. (NYSE:MTNB) Q4 2020 Earnings Conference Call March 29, 2021 8:00 AM ET Company Participants Peter Vozzo - Investor Relations Jerome Jabbour - Chief Executive Officer Keith Kucinski - Chief Financial Officer James Ferguson - Chief Medical Officer Raphael Mannino - Chief Scientific Officer Hui Liu - Chief Technology Officer Theresa Matkovits - Chief Development Officer Conference Call Participants Yasmeen Rahimi - Piper Sandler Gregory Fraser - Truist Securities Operator Hello ...
Matinas BioPharma(MTNB) - 2020 Q4 - Annual Report
2021-03-29 10:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 For the transition period from to Commission File Number: 001-38022 MATINAS BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware No. 46-3011414 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1545 Route 206 Sout ...