Company initiates Phase 1 clinical trial of Voriconazole Inhalation Powder, to treat invasive pulmonary aspergillosis (IPA)
Successfully completes
“This has been a time of important milestones and accomplishments for
“We also successfully completed our IPO on the
Recent Clinical and Corporate Highlights
Initiated Phase 1 clinical trial: On
This randomized, double-blind, placebo-controlled study will be conducted at a site in
Completed
Third Quarter Financial Results
Cash Position: As of
Research and Development (R&D) expenses: R&D expenses for the third quarter of 2019 were
General & Administrative (G&A) expenses: G&A expenses for the third quarter of 2019 were
Net Loss:
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
SAFE HARBOR
This press release contains forward-looking statements regarding
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/
Source:
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