Fusariosis

Financing is being led by new investor AMR Action Fund with strong participation from new investor ICG Life Sciences and existing investors MANCHESTER, United Kingdom, Sept. 12, 2024 (GLOBE NEWSWIRE) -- F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced a $100 million financing round. The financing is being led by new investor AMR Action Fund and co-led by ICG, with strong participation from existing investors Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl Healthcare Opportunities, Morningside Ventures, Brace Pharmaceuticals, and Merifin Capital. The proceeds from the financing will enable F2G to complete late-stage development, seek regulatory approval, and prepare for commercialization in the US of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other invasive fungal infections. Henry Skinner, Ph.D., Chief Executive Officer of AMR Action Fund and Toby Sykes Ph.D., Managing Director of ICG Life Sciences, will join the F2G Board of Directors. The financing is subject to customary Foreign Direct Investment (FDI) clearance by local authorities in Austria, where F2G has a 100%-owned subsidiary, and expected to close in the fourth quarter of 2024. Olorofim is the first orotomide antifungal, an entirely novel class of antifungal agents and is the only antifungal medication to be awarded a Breakthrough Therapy Designation for multiple indications by the US Food and Drug Administration (FDA). Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. It is anticipated to be used to treat patients with a serious invasive, rare fungal disease where existing treatments are inappropriate or no longer effective. Francesco Maria Lavino, Chief Executive Officer of F2G, said: “We are delighted to attract this additional capital investment into F2G, and we are thrilled to be working with the AMR Action Fund, an important player in the antimicrobial space, and ICG, a leading alternative asset manager. The addition of Dr. Skinner and Dr. Sykes to our Board will be invaluable as we move to our next stage of growth. This is a pivotal period for the Company as we conclude the final stages of development and preparation for commercialization of olorofim in the US and elsewhere. If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality.” Dr. Skinner commented: “Fungal infections are a growing threat to patients around the world and have a disproportionate impact on vulnerable populations, yet there has been a paucity of innovation in the field of antifungals. For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions. These therapies are increasingly failing in patients. We are thrilled to support F2G’s team as they develop this urgently needed therapy and seek regulatory approval.” Dr. Sykes commented: “Fungal pathogens continue to emerge and spread. This evolving threat underscores an urgent unmet medical need for advanced antifungal treatments. By investing in the development of novel antifungal drug candidates like olorofim, we hope to address this critical gap, ultimately making a meaningful and sustainable social impact on patients, their caregivers, and healthcare systems.” About F2G F2G is a clinical-stage biopharmaceutical company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: www.f2g.com About olorofim Olorofim (formerly, F901318) is F2G's leading candidate from the orotomide class and is currently in a Phase 2b open-label study (ClinicalTrials.gov Identifier: NCT03583164) in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. F2G has initiated a global Phase 3 trial ("OASIS") to compare treatment with olorofim versus liposomal amphotericin B followed by standard of care (SOC) in patients with invasive fungal disease caused by proven Invasive Aspergillus or probable lower respiratory tract disease by Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis, scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. About invasive aspergillosis Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, do not cause disease. However, Aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue, especially in immunocompromised hosts. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%. Media ContactKristin Politi, Ph.D.LifeSci Communicationskpoliti@lifescicomms.com 646-876-4783

Recent $10 million financing expected to fund planned development programs and operations into the second quarter of 2025 Discussions to secure a partner to advance MAT2203 into the Phase 3 ORALTO trial remain on track Company’s strategy to expand its LNC platform into inflammation and oncology supported by favorable in vivo data in multiple disease models Conference call begins at 4:30 p.m. Eastern time today BEDMINSTER, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports financial results for the three months ending March 31, 2024 and provides a business update. “We remain on track with active partnership discussions to advance oral MAT2203 into the ORALTO trial in invasive aspergillosis,” said Jerome D. Jabbour, Chief Executive Officer of Matinas. “These discussions aim to secure one or more development and commercial partners for this life-changing asset with a shared sense of urgency that can maximize its value in multiple geographies. Our confidence in oral MAT2203 continues to build as we see further evidence of favorable outcomes in extremely ill patients, some of whom have invasive fungal infections deemed even more difficult to treat than aspergillosis. We believe MAT2203 has the potential to change the treatment paradigm for a variety of invasive fungal infections by providing an effective, targeted, safer, and more convenient option. “Last month’s financing strengthened our balance sheet and better positioned us to advance other studies providing a strong foundation for our LNC platform programs,” he added. “We are highly encouraged by results from in vivo studies demonstrating a substantial reduction in the well-recognized toxicity of IV-docetaxel. In inflammation, we have been successful in orally delivering biologically active small oligonucleotides in several inflammatory disease models. Strategically, we continue to pursue studies with our LNC technology designed to establish its role as a potentially preferred next-generation intracellular oral drug delivery platform, potentially facilitating a robust internal and external pipeline of drug candidates in multiple high-value indications.” Key Program Updates MAT2203 (Oral Amphotericin B) Program Active negotiations are progressing to secure a partnership to commence the Phase 3 ORALTO registrational trial with oral MAT2203. The Phase 3 randomized, multicenter, open-label, adjudicator-blinded ORALTO trial will evaluate the efficacy and safety of MAT2203 as an oral step-down therapy following two days of treatment with AmBisome® (liposomal IV-amphotericin B) compared with the standard of care in patients with invasive aspergillosis who have limited treatment options. An in vivo study of oral MAT2203 demonstrated prolonged and enhanced survival, reduced fungal burden and improvement in lung infection compared with placebo in treating the pulmonary mucormycosis fungal infections in immunosuppressed mice. The results were reported in the manuscript “Efficacy of an oral lipid nanocrystal (LNC) formulation of amphotericin B (MAT2203) in the neutropenic mouse model of pulmonary mucormycosis” (Gu, et al.) published in the peer-reviewed Journal of Antimicrobial Agents and Chemotherapy. To date, Matinas has enrolled 22 patients with severe and sometimes life-threatening fungal infections in its Compassionate/Expanded Use Access Program, with additional patients under evaluation. The infections treated involve a variety of micro-organisms including Aspergillus, Mucorales species, Candidiasis, Fusarium, Histoplasmosis, and suspected Coccidioides at multiple sites of infection including brain, bladder/colon, bone, lung, sinus, and skin. The majority of enrolled patients are post-transplant or are undergoing treatment for underlying malignancies. LNC Platform Update Two abstracts (one an oral presentation) highlighting recent favorable data from ex vivo, in vitro and in vivo studies evaluating the use of Matinas’ LNC platform for the oral targeted delivery of small oligonucleotides are being presented at the American Society of Gene & Cell Therapy’s (ASGCT) 27th Annual Meeting in May. A new formulation of LNC-miriplatin, an insoluble platinum chemotherapeutic approved in Japan for hepatocellular carcinoma has been developed. In vitro testing demonstrated strong cellular uptake and tumor cell-killing capabilities. Next steps are to assess the formulation in vivo. LNC-miriplatin would be the second cancer agent successfully formulated with LNCs. First Quarter Financial Results The Company reported no revenue for the first quarter of 2024, compared with $1.1 million for the first quarter of 2023, which was generated from research collaborations with BioNTech SE and Genentech Inc. Total costs and expenses for the first quarter of 2024 were $5.9 million compared with $6.7 million for the first quarter of 2023. The decrease was primarily due to lower clinical development expenses, personnel costs, and administrative expenses. The net loss for the first quarter of 2024 was $5.8 million, or $0.03 per share, compared with a net loss for the first quarter of 2023 of $5.5 million, or $0.03 per share. Cash, cash equivalents and marketable securities as of March 31, 2024 were $8.1 million compared with $13.8 million as of December 31, 2023. Subsequent to the close of the quarter, in April the Company raised gross proceeds of $10.0 million through a registered direct offering. Based on current projections, the Company believes its cash position is sufficient to fund planned operations into the second quarter of 2025. Conference Call and Webcast Matinas will host a conference call and webcast today beginning at 4:30 p.m. Eastern time. To participate in the call, please dial 877-484-6065 or 201-689-8846. The live webcast will be accessible on the Investors section of the company’s website and archived for 90 days. About Matinas BioPharmaMatinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology. Matinas’ lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent, can be associated with significant toxicity. Matinas’ LNC platform provides oral delivery of amphotericin B without the significant nephrotoxicity otherwise associated with IV-delivered formulations. Combining comparable fungicidal activity with targeted delivery results in a lower risk of toxicity and potentially creates the ideal antifungal agent for the treatment of invasive fungal infections. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in HIV patients suffering from cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will be further evaluated in a single Phase 3 registration trial (the “ORALTO” trial) as an oral step-down monotherapy following treatment with AmBisome® (liposomal amphotericin B) compared with the standard of care in patients with invasive aspergillosis who have limited treatment options. In addition to MAT2203, preclinical and clinical data have demonstrated that this novel technology can potentially provide solutions to many challenges of achieving safe and effective intracellular delivery of both small molecules and larger, more complex molecular cargos including small oligonucleotides such as ASOs and siRNA. The combination of its unique mechanism of action and flexibility with routes of administration (including oral) positions Matinas’ LNC technology to potentially become a preferred next-generation orally available intracellular drug delivery platform. For more information, please visit www.matinasbiopharma.com. Forward-looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to our business activities, our strategy and plans, the potential of our LNC platform technology, and the future development of our product candidates, including MAT2203, the Company’s ability to identify and pursue development, licensing and partnership opportunities for its products, including MAT2203, or platform delivery technologies 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 continue as a going concern, 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 Contact: LHA Investor RelationsJody Cain Jcain@lhai.com310-691-7100 [Financial Tables to Follow] Matinas BioPharma Holdings, Inc.Condensed Consolidated Balance Sheets(in thousands, except for share data) March 31, 2024 December 31, 2023 (Unaudited) (Audited) ASSETS: Current assets: Cash and cash equivalents $1,071 $4,787 Marketable debt securities 7,039 8,969 Restricted cash – security deposit 50 50 Prepaid expenses and other current assets 2,129 1,737 Total current assets 10,289 15,543 Non-current assets: Leasehold improvements and equipment – net 1,829 1,923 Operating lease right-of-use assets – net 2,919 3,064 Finance lease right-of-use assets – net 20 21 In-process research and development 3,017 3,017 Goodwill 1,336 1,336 Restricted cash – security deposit 200 200 Total non-current assets 9,321 9,561 Total assets $19,610 $25,104 LIABILITIES AND STOCKHOLDERS’ EQUITY: Current liabilities: Accounts payable $473 $514 Accrued expenses 839 1,447 Operating lease liabilities – current 681 656 Financing lease liabilities – current 5 5 Total current liabilities 1,998 2,622 Non-current liabilities: Deferred tax liability 341 341 Operating lease liabilities – net of current portion 2,697 2,877 Financing lease liabilities – net of current portion 16 18 Total non-current liabilities 3,054 3,236 Total liabilities 5,052 5,858 Stockholders’ equity: Common stock par value $0.0001 per share, 500,000,000 shares authorized at March 31, 2024 and December 31, 2023; 217,482,830 and 217,264,526 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 22 22 Additional paid-in capital 196,067 195,018 Accumulated deficit (181,397) (175,573)Accumulated other comprehensive loss (134) (221)Total stockholders’ equity 14,558 19,246 Total liabilities and stockholders’ equity $19,610 $25,104 Matinas BioPharma Holdings, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data)Unaudited Three Months Ended March 31, 2024 2023 Revenue: Contract revenue $— $1,096 Costs and Expenses: Research and development 3,446 3,970 General and administrative 2,456 2,712 Total costs and expenses 5,902 6.682 Loss from operations (5,902) (5,586)Other income, net 78 73 Net loss $(5,824) $(5,513)Net loss per share – basic and diluted $(0.03) $(0.03)Weighted average common shares outstanding: Basic and diluted 217,358,085 217,264,526 Other comprehensive gain, net of tax Unrealized gain on securities available-for-sale 87 229 Other comprehensive gain, net of tax 87 229 Comprehensive loss $(5,737) $(5,284)

Fungal disease Fusarium head blight (FHB) is on the rise due to increasingly humid conditions induced by climate change during the wheat growing season, but a fundamental discovery could help reduce its economic harm. Fungal disease Fusarium head blight (FHB) is on the rise due to increasingly humid conditions induced by climate change during the wheat growing season, but a fundamental discovery by University of Adelaide researchers could help reduce its economic harm. While some types of wheat are resistant to FHB thanks to the action of the TaHRC gene at the Fhb1 locus, how this gene functions in wheat cells was unknown until now. Collaborating with Nanjing Agriculture University, the University of Adelaide research team has shown TaHRC works in the nucleus of wheat cells, and it can either increase or decrease a plant's susceptibility to FHB. "There are two variants of TaHRC that have opposing effects on the condensation of a specific protein complex within the nucleus," says Dr Xiujuan Yang, from the University's School of Agriculture, Food and Wine. "When condensed, the complex leads to susceptibility to FHB, whereas when diffused, it provides resistance against FHB. "We are the first to reveal the function of protein complex condensation in response to a major crop fungal disease, providing insight into the mode of action of protein complexes in cereal defence responses." FHB has caused significant harm to Australia's wheat industry in recent years, with crops in the 2022 season suffering up to 100 per cent yield losses. The disease has been on the rise globally since the 1970s, but climate change has increased its prevalence. "Australia's reputation for producing high-quality wheat has been built on fortuitous climate conditions during flowering and grain fill, typically coinciding with the dry season, which helps avoid many fungus-caused diseases that thrive in humid weather," says Dr Yang. "However, in the background of climate change, a wet spring in 2022 led to Fusarium head blight becoming widespread across eastern Australia." Australian durum wheat varieties are all highly susceptible to FHB, but it is unclear what level of resistance exists in bread-wheat varieties. Dr Yang hopes this fundamental discovery, published in Cell Host & Microbe, will counteract the growing prevalence of FHB and provide assurance to Australian growers. "Our findings offer exciting prospects for developing new and enhanced forms of Fusarium head blight resistance," Dr Yang says. "By understanding the underlying mechanisms beyond Fhb1, we can innovate breeding strategies to diversify resistance sources. "Our research opens the door to the development of more resilient and sustainable wheat varieties for future agriculture, and might shed light onto other Fusarium-caused diseases, such as crown rot."