공시 • Dec 13
TFF Pharmaceuticals, Inc.(NasdaqCM:TFFP) dropped from NASDAQ Composite Index TFF Pharmaceuticals, Inc. has been dropped from the NASDAQ Composite Index . 공시 • Dec 11
Nasdaq Determines to Delist Common Stock of TFF Pharmaceuticals On December 4, 2024, TFF Pharmaceuticals, Inc. (Company") received a determination letter (the Delisting Notification") from the Nasdaq Stock Market (Nasdaq") stating that the Nasdaq staff determined, in accordance with Nasdaq Listing Rules 5101 and 5110(b) and Nasdaq Listing Rule IM 5101-1, that the Company's common stock will be delisted from The Nasdaq Stock Market. The Delisting Notification states that the Nasdaq staff's determination was based on (i) the Company's previously announced Plan of Dissolution and associated public interest concerns raised by it; (ii) concerns regarding the residual equity interest held by the Company's existing stockholders; and (iii) concerns about the Company's ability to sustain compliance with all requirements for continued listing on the Nasdaq Stock Market. The Delisting Notification further states that trading of the Company's common stock will be suspended at the opening of business on December 13, 2024, and a Form 25-NSE will be filed by the Nasdaq with the SEC, which will remove the Company's securities from listing and registration on the Nasdaq. The Delisting Notification states that the Company may appeal the Nasdaq staff's determination to delist the Company's common stock, however the Company does not intend to appeal the staff's determination as of the date of this report. New Risk • Aug 24
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.9% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Market cap is less than US$10m (€8.21m market cap, or US$9.19m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$891k net loss in 3 years). Share price has been volatile over the past 3 months (8.9% average weekly change). Revenue is less than US$5m (US$1.2m revenue). New Risk • Aug 21
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 54% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Market cap is less than US$10m (€6.76m market cap, or US$7.54m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$891k net loss in 3 years). Revenue is less than US$5m (US$1.2m revenue). Reported Earnings • Aug 16
Second quarter 2024 earnings released: US$1.22 loss per share (vs US$3.47 loss in 2Q 2023) Second quarter 2024 results: US$1.22 loss per share (improved from US$3.47 loss in 2Q 2023). Revenue: US$650.2k (up 95% from 2Q 2023). Net loss: US$4.48m (loss narrowed 11% from 2Q 2023). Revenue is forecast to grow 73% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. 공시 • Aug 06
TFF Pharmaceuticals, Inc. Provides Continued Positive Outcomes from Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection TFF Pharmaceuticals, Inc. provided an update from the Company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection. Clinical Trial Update Patient enrollment has accelerated with 13 patients now enrolled in Phase 2 trial TFF TAC at 20% of the oral tacrolimus dose prevented acute rejection and achieved >80% of the oral trough blood levels leading to diminished drug burden No signs or symptoms suggestive of acute rejection No use of pulse corticosteroids for treatment of rejection No spirometry deterioration suggestive of acute rejection No chest x-ray findings suggestive of acute rejection No biomarker evidence of acute rejection (gene expression and donor-specific antibody) Lower doses and no first pass effect to generate drug metabolites decreases drug burden with TFF TAC compared with oral tacrolimus. 9 out of 9 (100%) patients who completed the 12-week treatment period with TFF TAC chose to remain on the therapy by proceeding to the long-term extension phase; 2 patients have been treated for over 1 year, and 6 patients have been treated for more than 6 months; Total patient exposure to TFF TAC therapy has now reached 2,063 days, or a total of 5.65 years. PK data from the Phase 2 study continue to indicate that TFF TAC dosing results in reduced systemic variability of tacrolimus; the systemic tacrolimus trough to peak concentration swings that occur with oral tacrolimus are not present with TFF TAC, which is predicted to reduce the risk of organ rejection and systemic toxicities such as chronic kidney disease. Confirmatory biomarker data from the Phase 2 study also remain positive: Updated biomarker data indicate a 6.5-fold reduction in the number of abnormally expressed rejection-related gene sets after 12 weeks of treatment with TFF TAC. These data further suggest TFF TAC has the potential to provide sufficient immunosuppression to prevent rejection 23% to 4% reduction (-85%) in the expression of rejection related genes: New biomarker data exploring the presence of donor-specific antibodies (DSA) are now available in the first 8 patients from the study. DSA is known to drive antibody-mediated rejection and is generated when there is insufficient immune suppression systemically allowing the formation of antibodies in the lymph nodes against the transplanted (donor) organ. DSA was negative for the first 8 patients on oral tacrolimus, and DSA remained negative after 12 weeks of treatment with TFF TAC. With respect to TFF TAC safety and tolerability, there has been no mortality. The majority of treatment emergent adverse events were Grade 2 (moderate) or lower with no bronchospasm or wheezing reported. Kidney function has been maintained. One patient was transitioned to a dose of TFF TAC that was too low, which led to blood trough levels that were >50% below the protocol-specified minimum. This patient experienced signs and symptoms of acute rejection (but minimal on histopathology). TFF TAC was discontinued as required by the protocol and oral tacrolimus was resumed. The acute rejection episode has resolved. TFF is finalizing the design of the next study with TFF TAC in close collaboration with clinical investigators and in communication with regulatory authorities and plans to provide additional updates on the program including a regulatory update later in the fall. 공시 • Jun 24
Tff Pharmaceuticals, Inc. Provides Regulatory Update on Tacrolimus Inhalation Powder (Tff Tac) Clinical Program for the Prevention of Lung Transplant Rejection TFF Pharmaceuticals, Inc. announced a regulatory update on the Company’s TFF TAC clinical program following its recent interaction with the U.S. Food and Drug Administration (FDA). 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 TAC. Based on this feedback, the Company does not expect a significant change to either its timelines or the estimated costs associated with the clinical advancement of TFF TAC. Board Change • May 28
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. 3 experienced directors. No highly experienced directors. Independent Director Bob Mills is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 공시 • May 18
TFF Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $2.055 million. TFF Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $2.055 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering