Company initiates Phase 1 clinical trial of Voriconazole Inhalation Powder, to treat invasive pulmonary aspergillosis (IPA)
- Company initiates Phase 1 clinical trial of Voriconazole Inhalation Powder, to treat invasive pulmonary aspergillosis (IPA)
- Successfully completes $24 million initial public offering of common stock
AUSTIN, Texas--(BUSINESS WIRE)-- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), 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 its third quarter 2019 financial results and provided a corporate update on recent significant events.
“This has been a time of important milestones and accomplishments for TFF Pharmaceuticals,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “We are very pleased to report that we recently initiated and began dosing subjects in the Phase 1 clinical trial of our Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA. This unique formulation of Voriconazole, which is considered to be the most effective antifungal drug for treating IPA, directly targets the site of the fungal infection in the lung and has the potential to be the first dry powder inhaled fungicide on the market.”
“We also successfully completed our IPO on the Nasdaq Stock Market,” continued Mr. Mattes. “We believe this will provide TFF with the funds for the development of our two initial product candidates, Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder, through the completion of their proposed clinical studies, as well as additional product development.”
Recent Clinical and Corporate Highlights
Initiated Phase 1 clinical trial: On November 25, we initiated a Phase 1 clinical trial of Voriconazole Inhalation Powder and began dosing individuals. This is the Company’s next-generation, direct-to-lung, inhaled dry powder version of Voriconazole for treating Invasive Pulmonary Aspergillosis.
This randomized, double-blind, placebo-controlled study will be conducted at a site in Canada for purposes of evaluating, under a U.S. IND and Canadian CTA, the safety, tolerability and pharmacokinetic profile of Voriconazole Inhalation Powder in 64 healthy subjects.
Completed $24 Million Initial Public Offering: In October, the Company closed its initial public offering of 4.8 million shares of common stock, including the exercise by the underwriter of an overallotment option, at a public offering price of $5.00 per share. TFF Pharmaceuticals began trading under the ticker symbol “TFFP” on October 25, 2019 on the Nasdaq Capital Market. Net proceeds to the Company were approximately $22.3 million after deducting underwriting discounts, commissions and other offering expenses.
Third Quarter Financial Results
Cash Position: As of September 30, 2019, TFF Pharmaceuticals reported cash and cash equivalents of $10.6 million, which does not give effect to the Company’s receipt of approximately $22.3 million of net proceeds from its initial public offering in the fourth quarter.
Research and Development (R&D) expenses: R&D expenses for the third quarter of 2019 were $2.6 million, compared to $140,167 for the same period in 2018.
General & Administrative (G&A) expenses: G&A expenses for the third quarter of 2019 were $300,640, compared to $465,919 for the same period in 2018.
Net Loss: TFF Pharmaceuticals reported a net loss for the third quarter of 2019 of $2.8 million, compared to a net loss of $585,215 for the same period in 2018.
About TFF Pharmaceuticals’ Thin Film Freezing technology platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments, the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 39 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.
SAFE HARBOR
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder version of Voriconazole and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (ii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform and (iii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission on December 9, 2019. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
| TFF PHARMACEUTICALS, INC. | ||||||||||||||||||
| Three Months Ended | Three Months Ended | Nine Months Ended | January 24, 2018 to | January 1, 2018 to | ||||||||||||||
| Operating expenses | ||||||||||||||||||
| Research and development | $ | 2,563,528 | $ | 140,167 | $ | 5,554,046 | $ | 759,355 | $ | * | ||||||||
| General and administrative | 300,640 | 465,919 | 1,721,691 | 2,243,788 | * | |||||||||||||
| Total operating expenses | 2,864,168 | 606,086 | 7,275,737 | 3,003,143 | * | |||||||||||||
| Loss from operations | (2,864,168 | ) | (606,086 | ) | (7,275,737 | ) | (3,003,143 | ) | * | |||||||||
| Other income | * | |||||||||||||||||
| Interest income | 25,865 | 20,871 | 67,699 | 33,268 | * | |||||||||||||
| Total other income | 25,865 | 20,871 | 67,699 | 33,268 | * | |||||||||||||
| Net loss | (2,838,303 | ) | (585,215 | ) | (7,208,038 | ) | (2,969,875 | ) | * | |||||||||
| * | ||||||||||||||||||
| Preferred stock dividend | (258,635 | ) | (219,498 | ) | (768,876 | ) | (505,516 | ) | * | |||||||||
| Net loss applicable to common stock | $ | (3,096,938 | ) | $ | (804,713 | ) | $ | (7,976,914 | ) | $ | (3,475,391 | ) | $ | * | ||||
| Net loss applicable to common stock per share, basic and diluted | $ | (0.70 | ) | $ | (0.18 | ) | $ | (1.81 | ) | $ | (0.79 | ) | ||||||
| Weighted average common shares outstanding, basic and diluted | 4,400,000 | 4,400,000 | 4,400,000 | 4,400,000 | ||||||||||||||
| TFF PHARMACEUTICALS, INC. | |||||||||
| As of September 30, 2019 | As of December 31, 2018 | ||||||||
| Assets | (Unaudited) | ||||||||
| Current Assets | |||||||||
| Cash and cash equivalents | $ | 10,550,569 | $ | 10,261,671 | |||||
| Prepaid assets and other current assets | 20,297 | 12,065 | |||||||
| Total Current Assets | 10,570,866 | 10,273,736 | |||||||
| Deferred offering costs | 461,893 | 127,768 | |||||||
| Total Assets | $ | 11,032,759 | $ | 10,401,504 | |||||
| Liabilities and Stockholders’ Deficit | |||||||||
| Current Liabilities | |||||||||
| Accounts payable | $ | 691,105 | $ | 428,645 | |||||
| Accrued dividends payable | 1,497,226 | 728,350 | |||||||
| Total Liabilities | 2,188,331 | 1,156,995 | |||||||
| Commitments and Contingencies (Note 4) | |||||||||
| Series A Preferred Stock | |||||||||
| Series A Preferred Stock, $0.001 par value, 10,000,000 shares authorized; 8,930,000 shares issued and outstanding as of September 30, 2019 and 5,662,000 shares issued and outstanding as of December 31, 2018, respectively (Liquidation Preference of $23,822,226) | 19,684,197 | 12,485,971 | |||||||
| Stockholders’ Deficit: | |||||||||
| Common stock, $0.001 par value, 45,000,000 shares authorized; 4,000,000 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 4,000 | 4,000 | |||||||
| Additional paid-in capital | 206,455 | 596,724 | |||||||
| Accumulated deficit | (11,050,224 | ) | (3,842,186 | ) | |||||
| Total Stockholders’ Deficit | (10,839,769 | ) | (3,241,462 | ) | |||||
| Total Liabilities, Series A Preferred Stock and Stockholders’ Deficit | $ | 11,032,759 | $ | 10,401,504 | |||||
| TFF PHARMACEUTICALS, INC. | ||||||||||||
| For the Nine Months Ended | January 24, 2018 to | January 1, 2018 to | ||||||||||
| Cash Flows from Operating Activities | ||||||||||||
| Net loss | $ | (7,208,038 | ) | $ | (2,969,875 | ) | — | |||||
| Adjustment to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Stock based compensation | 378,607 | 1,235,946 | — | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Prepaid assets | (261,204 | ) | (36,305 | ) | — | |||||||
| Accounts payable | 181,307 | 426,845 | (1,833 | ) | ||||||||
| Net Cash Used in Operating Activities | (6,909,328 | ) | (1,343,389 | ) | (1,833 | ) | ||||||
| Cash Flows from Investing Activities | ||||||||||||
| Net Cash Used in Investing Activities | — | — | — | |||||||||
| Cash Flows from Financing Activities | ||||||||||||
| Net Transfers from parent | — | (6,542 | ) | (1,833 | ) | |||||||
| Proceeds from issuance of preferred stock | 7,198,226 | 12,485,971 | — | |||||||||
| Net Cash Provided by Financing Activities | 7,198,226 | 12,479,429 | (1,833 | ) | ||||||||
| Net Increase in Cash and Cash Equivalents | 288,898 | 11,136,040 | — | |||||||||
| Cash and Cash Equivalents – beginning of period | 10,261,671 | — | — | |||||||||
| Cash and Cash Equivalents – end of period | $ | 10,550,569 | $ | 11,136,040 | — | |||||||
| Supplemental disclosure of non-cash investing and financing activities: | ||||||||||||
| Common stock issued to former parent for acquired assets | $ | — | $ | 4,000 | — | |||||||
| Accrued offering costs | $ | 81,153 | $ | 60,890 | — | |||||||
| Accrued dividend | $ | 768,876 | $ | 505,516 | — | |||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20191209005807/en/
Contacts
Company Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
gmattes@tffpharma.com
737-802-1973
Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358
Investor Relations and Media Contact:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779
Source: TFF Pharmaceuticals, Inc.
View this news release online at:
http://www.businesswire.com/news/home/20191209005807/en
