Acetaminophen

Patent application paves the way for a potential breakthrough in chronic pain treatment, offering renewed hope for millions BOSTON, Nov. 14, 2024 /PRNewswire/ -- CureLab Oncology, a clinical-stage biotech company dedicated to pioneering innovative therapies, announced a patent application for an innovative chronic pain treatment centered on its p62/SQSTM1 DNA plasmid. This development, which leverages CureLab's chronic inflammation therapeutic, Elenagen™, signifies a potential paradigm shift in addressing chronic pain, a pervasive health challenge that affects millions globally. Continue Reading With this patent, CureLab Oncology positions its lead therapeutic, Elenagen™, to address the limitations of existing chronic pain treatments, such as NSAIDs (nonsteroidal anti-inflammatory drugs), acetaminophen, COX-2 inhibitors, antidepressants, anti-seizure medications, and opioids. With this patent, CureLab Oncology aims to address the limitations of existing chronic pain treatments, such as NSAIDs (nonsteroidal anti-inflammatory drugs), acetaminophen, COX-2 inhibitors, antidepressants, anti-seizure medications, and opioids. While these medications offer varying degrees of pain relief, they often come with a range of side effects, including gastrointestinal problems, kidney problems, stomach bleeding, ulcers, dizziness, drowsiness, nausea, and potential addiction. The patent emphasizes the urgent need for more effective chronic pain medications with fewer side effects. The patent application encompasses the utilization of p62/SQSTM1 DNA to combat a wide spectrum of chronic pain conditions, including arthritis, back pain, headaches, cancer pain, neuropathic pain, and fibromyalgia. This therapeutic strategy operates by modulating the body's inflammatory response, a critical factor in the development and persistence of chronic pain. "Chronic pain often stems from persistent inflammation, a complex biological response that can disrupt the body's natural healing processes," explained Dr. Alexander Shneider, CEO of CureLab Oncology. "Elenagen, our innovative p62-based therapy, targets this underlying inflammation, promoting resolution and potentially alleviating pain at its source." This groundbreaking therapy holds immense promise for both humans and animals suffering from chronic pain. Preclinical investigations employing animal models have illuminated the efficacy of this therapy in mitigating pain severity and augmenting the quality of life. Notably, the therapy exhibits a favorable safety profile, with no substantial adverse effects detected in the studies. The global chronic pain treatment market is expected to reach $131.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030. This growth is driven by the increasing prevalence of chronic pain, the aging population, and the rising demand for effective and non-addictive pain management options. With its potential for fewer side effects and broader applications compared to current treatments, CureLab's p62-based therapy is positioned to meet the growing demand of the growing chronic pain market. "Our patenting strategy for this chronic pain treatment aligns with our successful approach for other therapies," said Ilya Lapshin, general counsel for CureLab Oncology. "By initially filing a provisional patent application in the USA and subsequently seeking worldwide protection, we aim to secure comprehensive intellectual property rights for this groundbreaking innovation." To see CureLab's portfolio of patents, visit curelaboncology.com/ip and curelabveterinary.com/ip. About Elenagen CureLab's lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients enhancing the anti-cancer effects of chemotherapy. Experimental results also demonstrate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor. About CureLab Oncology CureLab Oncology Inc. is a pre-IPO, clinical-stage biotech company headquartered in the greater Boston area, Massachusetts. CureLab is dedicated to advancing new and safer therapeutics for solid tumors and other oncology and inflammatory indications. To learn more, visit curelab.com. Media contact: Tim Cox, ZingPR, [email protected] SOURCE CureLab Oncology Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LANGHORNE, Pa.--( BUSINESS WIRE )-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the third quarter ending September 30, 2024 and provided a business update. “ After a productive pre-BLA meeting with the FDA, we are working diligently to initiate a rolling submission for MOLBREEVI by the end of this year, with plans to complete the BLA submission by the end of 1Q 2025—thus enabling a potential approval in the U.S. by the end of 2025, if priority review is granted,” said Matt Pauls, Chair and CEO, Savara. “ BLA submission, coupled with the submission of the MAA to the EMA by the end of 2025, are major regulatory milestones that could bring us one step closer to providing aPAP patients in the U.S. and Europe with the first and only approved therapeutic option for this rare and debilitating lung disease. In parallel, we are accelerating the build-out of our commercial capabilities, complimented by ongoing market development initiatives, to ensure the approximately 3,600 diagnosed aPAP patients in the U.S. get access to MOLBREEVI post-approval. Lastly, after strengthening our balance sheet, we believe our cash runway now extends from the end of 2026 through the second quarter of 2027.” Third Quarter Financial Results (Unaudited) Savara's net loss for the third quarter of 2024 was $24.2 million, or $(0.11) per share, compared with a net loss of $16.6 million, or $(0.10) per share, for the third quarter of 2023. Research and development expenses increased by $6.4 million, or 46.5%, to $20.3 million for the three months ended September 30, 2024 from $13.9 million for the three months ended September 30, 2023. This increase was primarily due to the performance of tasks related to our MOLBREEVI program, which includes ~$3.7 million of costs related to our chemistry, manufacturing, and controls activities, primarily driven by initiatives to establish our second drug substance manufacturer, ~$0.2 million of clinical costs driven by the pediatric study, ~$1.0 million of costs related to regulatory affairs and quality assurance, and ~$1.5 million due to an increase in personnel and related costs as well as other departmental overhead. General and administrative expenses increased by $1.9 million, or 45.0%, to $6.0 million for the three months ended September 30, 2024 from $4.1 million for the three months ended September 30, 2023. The increase was due to personnel and related costs of ~$0.8 million, certain commercial activities of ~$0.9 million, and other departmental overhead of ~$0.2 million. As of September 30, 2024, the Company had cash, cash equivalents and short-term investments of ~$219.4 million and debt of ~$26.6 million. About aPAP Autoimmune PAP (aPAP) is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli (or air sacs) of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is delivered via an investigational eFlow ® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com . (X, formerly known as Twitter: @SavaraPharma , LinkedIn: www.linkedin.com/company/savara-pharmaceuticals). Forward-Looking Statements Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the anticipated timing of our BLA submission and the potential timing for approval if priority review is granted, statements related to the anticipated timing of our MAA submission, statements related to the build-out of our commercial capabilities and our ongoing market development initiatives, and our expectation the Company is sufficiently capitalized through the second quarter of 2027. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for aPAP; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. *MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. Financial Information to Follow Savara Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except for share and per share amounts) Unaudited Three months ended Nine months ended September 30, September 30, 2024 2023 2024 2023 Operating expenses: Research and development $ 20,311 $ 13,867 $ 54,735 $ 31,516 General and administrative 6,013 4,147 17,189 10,816 Depreciation and amortization 33 30 98 45 Total operating expenses 26,357 18,044 72,022 42,377 Loss from operations (26,357 ) (18,044 ) (72,022 ) (42,377 ) Other income (expense), net: 2,109 1,445 5,185 3,778 Net loss attributable to common stockholders $ (24,248 ) $ (16,599 ) $ (66,837 ) $ (38,599 ) Net loss per share - basic and diluted $ (0.11 ) $ (0.10 ) $ (0.35 ) $ (0.25 ) Weighted average shares - basic and diluted 211,847,651 174,696,191 192,398,514 152,778,072 Other comprehensive loss 1,179 (323 ) 570 (337 ) Total comprehensive loss $ (23,069 ) $ (16,922 ) $ (66,267 ) $ (38,936 ) Savara Inc. and Subsidiaries Condensed Consolidated Balance Sheet Data (in thousands) (Unaudited) September 30, December 31, 2024 2023 Cash, cash equivalents, and short-term investments $ 219,440 $ 162,319 Working capital 213,607 155,350 Total assets 238,817 177,564 Total liabilities 39,468 37,192 Stockholders’ equity: 199,349 140,372