FOXBOROUGH, Mass., Feb. 6, 2025 /PRNewswire/ -- TFF Pharmaceuticals, Inc. (Nasdaq: TFFP) today announced that the Company has provided notification to The Nasdaq Stock Market, LLC ("Nasdaq") of its intent to voluntarily delist the Company's common stock, par value $0.001 per share (the "Common Stock"), from the Nasdaq Capital Market. The Company expects to file a Form 25 (Notification of Removal from Listing) with the Securities and Exchange Commission (the "SEC") and Nasdaq relating to the delisting of its ...

Core Viewpoint - TFF Pharmaceuticals, Inc. (TFFP) has been upgraded to a Zacks Rank 1 (Strong Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily based on a company's changing earnings picture, specifically the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade for TFF Pharmaceuticals reflects a positive outlook on its earnings, which could positively affect its stock price [4][6]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to significant stock price movements based on their buying or selling activities [5]. Recent Performance of TFF Pharmaceuticals - For the fiscal year ending December 2024, TFF Pharmaceuticals is expected to earn -$4.28 per share, representing a 63.9% change from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for TFF Pharmaceuticals has increased by 34.3%, indicating a positive trend in earnings estimates [9]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of TFF Pharmaceuticals to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [11].

TFF Pharmaceuticals, Inc. (TFFP) came out with a quarterly loss of $1.22 per share versus the Zacks Consensus Estimate of a loss of $1.70. This compares to loss of $3.50 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 28.24%. A quarter ago, it was expected that this company would post a loss of $2.20 per share when it actually produced a loss of $2.40, delivering a surprise of -9.09%. Over the last four quarters, the company ...

Financial Position and Liquidity - The company had total assets of approximately $9.5 million and working capital of approximately $2.3 million as of June 30, 2024[128] - The company's liquidity included approximately $4.4 million of cash and cash equivalents as of June 30, 2024[128] - The company incurred a net loss of $10.2 million for the six months ended June 30, 2024, compared to a net loss of $12.1 million for the same period in 2023[134] - The company had an accumulated deficit of $128.5 million as of June 30, 2024[134] - The company expects to continue incurring substantial losses for the foreseeable future and is uncertain when or if it will achieve profitability[135] Clinical Development and Product Candidates - The company's TFF TAC product candidate is currently in Phase 2 clinical development, with positive Phase 2 data announced in March 2024[8] - The company is evaluating strategic options for its TFF VORI product candidate as of March 2024[8] - The company plans to end enrollment in the TFF TAC Phase 2 study in the second half of 2024[130] - The company completed Phase I human clinical trials for TFF TAC and TFF VORI in 2020 and 2021, and initiated Phase 2 trials in 2022[166] - In March 2024, the company prioritized clinical development of TFF TAC based on positive Phase 2 data, while evaluating strategic options for TFF VORI[166] - The company's initial dry powder drug candidates, TFF TAC and TFF VORI, follow the FDA's 505(b)(2) regulatory pathway, potentially requiring additional clinical trials for new indications or improved safety claims[161] Business Model and Dependencies - The company's business model is entirely dependent on patent rights licensed from the University of Texas at Austin, and the loss of these rights would likely cause the business to fail[136] - The company's business model includes pursuing the development of approved off-patent drugs through the FDA's 505(b)(2) pathway, while novel candidates will require a full NDA through the 505(b)(1) pathway[163] - The company's business model is dependent on patent rights licensed from the University of Texas at Austin, with limited control over enforcement and prosecution[190] Regulatory and Compliance Risks - The company's independent registered public accounting firm expressed substantial doubt about its ability to continue as a going concern due to lack of revenue, significant losses, and need for additional capital[129] - The company faces risks related to product regulation, including potential delays or rejections in regulatory approvals due to changes in policies, statutes, or regulations[164] - The company's contract manufacturers must comply with FDA regulations, and failure to do so could result in sanctions, delays, or withdrawal of approvals[152] - The company has not submitted an NDA to the FDA or comparable applications to other regulatory authorities for any of its product candidates as of the report date[160] - Even if regulatory approval is obtained, the company may face ongoing obligations, post-approval studies, and potential restrictions or withdrawals from the market[170] - The company may be subject to significant restrictions or requirements, such as Risk Evaluation and Mitigation Strategies (REMS), imposed by the FDA or foreign regulatory authorities[171] - FDA regulations may impose significant liability and fines if the company promotes off-label uses of its products[174] - Failure to comply with international regulatory requirements could delay or prevent product launches in certain countries, reducing market potential[177] - Delays in clinical trials due to regulatory holds or manufacturing issues could increase costs and delay revenue generation[186] - Changes in regulatory requirements may necessitate protocol amendments, increasing development costs and timelines[188] Market and Commercialization Risks - The company currently has no sales and marketing organization and plans to rely on third-party relationships for commercialization, which may limit control over sales and distribution activities[147][149] - The company's success depends on the acceptance of its product candidates by the medical community, including physicians, patients, and health care payors, which may require significant resources for education and marketing[167] - Third-party payors may limit reimbursement or coverage for the company's products, impacting profitability[189] - The Medicare Modernization Act (MMA) may reduce reimbursement rates for the company's products, impacting profitability[182] - The Health Care Reform Law could increase Medicaid drug rebates and impose annual fees on branded prescription drug manufacturers[183] Intellectual Property and Legal Risks - The company faces significant risks in protecting its intellectual property, including potential challenges to patent validity and enforceability, which could impact its competitive advantage and commercial success[191][192][193] - The company may rely on trade secrets and know-how for technology protection, but these methods are difficult to enforce and may not provide adequate protection against competitors[194][195] - The company's product candidates could infringe on third-party intellectual property, leading to costly litigation, delays in commercialization, and potential licensing requirements[197][198] - Increased risk of securities class action litigation due to stock price volatility, potentially leading to substantial costs and diversion of management resources[210] - Delaware law and company charter provisions may delay or discourage favorable takeovers, limiting stockholder opportunities to receive premium share prices[211][212] - Delaware Court of Chancery designated as exclusive forum for certain stockholder litigation, potentially limiting favorable judicial outcomes for disputes[213][214] Manufacturing and Supply Chain Risks - The company relies on third-party contract manufacturers for the production of its product candidates, and any failure by these manufacturers could disrupt commercialization efforts[150][151] - The company's contract manufacturers must comply with FDA regulations, and failure to do so could result in sanctions, delays, or withdrawal of approvals[152] Economic and Geopolitical Risks - The company faces risks from unfavorable geopolitical and macroeconomic developments, including rising inflation rates, conflicts in Ukraine/Russia and Israel/Palestine, and related economic sanctions[140][142] - Inflation rates in the U.S. have increased recently, potentially leading to higher operating costs, reduced liquidity, and limited access to credit[141] Stock and Investor Risks - The company's stock price is highly volatile, with historical prices ranging from $1.35 to $528.50 per share since its IPO in October 2019[203] - The company's stock price is influenced by various factors, including market acceptance of its product candidates, regulatory developments, and general economic conditions[203] - Future capital raises could dilute existing shareholders' ownership and impose restrictions on the company's operations[204] - The company is classified as an "emerging growth company" under the JOBS Act, which allows for reduced disclosure requirements but may make its stock less attractive to investors[205][206] - The company must maintain effective internal controls over financial reporting to ensure accurate financial results and prevent fraud, with potential risks if deficiencies are identified[207] - The company has no plans to pay dividends in the foreseeable future, as it intends to reinvest earnings to cover operating costs and remain competitive[208] Product Liability and Legal Compliance - The company faces potential product liability risks from clinical testing and commercialization of its product candidates, which could result in substantial liabilities or limitations on commercialization[156] - The company's sales and marketing activities must comply with FDA rules, U.S. federal and state laws, and similar legal requirements in other countries, including fraud and abuse laws[172] Market Exclusivity and Reimbursement - Orphan drug designation provides potential market exclusivity for 7 years, but there is no guarantee the company will receive this designation for future candidates[180]

Patient enrollment has accelerated, now with 13 patients enrolled in trial TFF TAC at ~20% of the oral tacrolimus dose prevented acute rejection and achieved >80% of the previous oral trough blood levels -- leading to diminished drug burden 9 out of 9 (100%) patients who completed the 12-week treatment chose to remain on TFF TAC by proceeding to the long-term extension Phase; 2 patients have been treated for over a year and 6 patients have been treated for more than 6 months Observed a 6.5-fold reduction in ...

"In recent months, TFF Pharmaceuticals has made extraordinary progress in demonstrating how its leading formulation technology can be applied to generate innovative clinical-stage products with the potential to improve upon the current standard of care," said Oded Ben-Joseph, Ph.D., MBA, Managing Partner of Outcome Capital. "We look forward to identifying and evaluating opportunities to realize the full potential value of TFF Pharmaceutical's exciting Phase 2 assets." About TFF TAC TFF TAC is an inhaled dry ...

"We are pleased to announce this engagement with Outcome Capital, which is a well-recognized investment bank specializing in corporate advisory services to the life sciences industry," said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. "Today's announcement reflects the significant innovation and commercial potential of our two lead clinical assets, TFF VORI and TFF TAC, and we welcome the opportunity to work with Outcome Capital in evaluating select partnering or licensing opportuniti ...

Company to Provide More Detailed Regulatory Update in 3Q 2024 In April 2024, the Company submitted a briefing book to the FDA to help guide the next steps in the clinical development pathway for TFF TAC. Following its review of the briefing book, the FDA concurred that mitigation or prevention of tacrolimus associated toxicities without placing the lung allograft at risk will be an important therapeutic benefit and provided constructive feedback and valuable guidance on the roadmap for advancement of TFF TA ...

FORT WORTH, Texas, May 23, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) ("the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that the government will be advancing several next-generation medical countermeasures (MCMs) formulated with its Thin Film Freezing technology into advanced preclinical testing. TFF Pharmaceuticals is collabor ...

FORT WORTH, Texas, May 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (NASDAQ:TFFP) (the "Company" or "TFF Pharmaceuticals"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that, in collaboration with Cleveland Clinic, the Company is advancing multiple multivalent universal influenza vaccines to protect against seasonal and pandemic viruses into preclinica ...