TFFP TFF Pharmaceuticals Inc - Ordinary Shares
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Tacrolimus Inhalation Powder
Prophylaxis of lung allograft rejection
|
Phase 1
Phase 1
|
Phase 1 completion of SAD dosing announced October 20, 2020.
|
|
Voriconazole Inhalation Powder
Invasive Pulmonary Aspergillosis (IPA)
|
Phase 1
Phase 1
|
Phase 1 data released September 15, 2020. Phase 2 trial planned.
|
Latest News
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Corporate presentation and live webcast scheduled for Thursday, November 19, 2020 at 2:55 PM ET
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, has been invited to present at the Jefferies Virtual London Healthcare Conference, taking place virtually from November 17-19, 2020.
Glenn Mattes, President & CEO of TFF Pharmaceuticals, is scheduled to give a corporate overview on Thursday, November 19, 2020 at 2:55 PM ET, and will participate in one-on-one partnering meetings with investors and other conference attendees.
A live webcast of the presentation will be available at the following link: https://wsw.com/webcast/jeff141/tffp/1846800. Following the conference, an archived version of the webcast will be available under the Events Calendar tab in the Investors section of the Company's website.
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 42 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.View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005631/en/
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Signs Letter of Intent with Felix Biotechnology to license Thin Film Freezing technology for their bacteriophage products for lung inhalation
Signs worldwide co-development agreement with Augmenta Bioworks for monoclonal antibody therapeutics
Reports positive preclinical immunogenicity and efficacy for dry powder universal influenza formulation in collaboration with the University of Georgia
Reports positive Phase I initial efficacy data on Tacrolimus Inhalation Powder; Voriconazole Inhalation Powder program progresses to Phase II trial
Conference call and live webcast scheduled today, Thursday, November 5, 2020 at 4:30pm ET
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 reported financial results for the third quarter ended September 30, 2020, as well as provided a business update on recent corporate and clinical developments. The Company will discuss its clinical, corporate and financial highlights on a conference call and live webcast, scheduled today, Thursday, November 5, 2020 at 4:30pm ET.
"This has been another quarter of strong clinical progress and exceptional partnering activity for TFF Pharmaceuticals, further validating the dual-track business model we've established for the company, and demonstrating the technological capability and market potential of our Thin Film Freezing platform," said Glenn Mattes, President and CEO of TFF Pharmaceuticals.
"The two new agreements recently announced with Felix Biotechnology and Augmenta Bioworks represent the potential first-of-their-kind dry powder inhalation reformulations of bacteriophages and monoclonal antibodies, respectively," said Mattes. "This is the culmination of months of work by our scientific staff to take large, complex biologics and reformulate them for better efficacy, delivery and storage characteristics, thus enhancing their therapeutic value and market potential."
"Our ongoing work with the University of Georgia has successfully reformulated, for the first time, a potential universal flu vaccine into a dry powder for inhalation. This reformulation suggests immunogenicity and efficacy equivalent to liquid formulations, and could allow this protein vaccine to be more stable and long-lasting - removing logistical cold chain challenges that could limit the eventual distribution of a universal flu vaccine," said Mattes.
"Our three internal development programs continue to advance in the clinic," continued Mattes. "Our lead clinical program, Voriconazole Inhalation Powder, the first clinical study ever in healthy subjects of a direct-to-lung, dry-powder formulation for the treatment of Invasive Pulmonary Aspergillosis (IPA) successfully completed Phase 1 dosing and will enter Phase 2 trials."
"Our second clinical trial program, the Phase 1 dosing of healthy subjects of Tacrolimus Inhalation Powder, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection, has shown no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels," said Mattes. "And finally, our niclosamide program is on track and we are moving forward with both the oral and inhaled versions."
"This quarter, we also took important steps to expand our manufacturing capacity to develop and produce products currently in assessment with pharmaceutical company partners, and give us a secure third source for Thin Film Freezing dry powder inhalation products," continued Mattes.
"Despite the ongoing effects of the global pandemic, we continue to execute on our core strategies, thanks to the incredible efforts of our scientists, staff and business partners," concluded Mattes. "We are excited to further progress with our breakthrough TFF platform technology and we look forward to reporting on new developments in upcoming quarters."
Conference Call and Webcast Information
The Company will host a conference call today, Thursday, November 5, 2020, at 4:30 pm, Eastern Time, to review their clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:
U.S. Dial-In Number: Toll-Free: (877) 784-1702
International Dial-In Number (857) 770-0110
Conference ID: 9498042The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' website, https://tffpharma.com or directly at https://edge.media-server.com/mmc/p/wiw3v2y6. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. The conference call will also be available for replay for one month on the Company's website in the Events Calendar of the Investors section.
Recent Corporate and Clinical Highlights:
- Letter of Intent with Felix Biotechnology: On November 5, TFF announced signing a Letter of Intent with Felix Biotechnology, Inc of San Francisco reflecting the non-binding agreement in principle of the parties to negotiate and enter into a Collaboration, Development and License Agreement. Under the proposed agreement, Felix Biotechnology will obtain a non-exclusive license to TFF's thin-film freezing technology to develop and manufacture dry powder formulations of specified Felix bacteriophage products for inhalation delivery directly to the lungs of patients. Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix phage products. The Letter of Intent is subject to certain conditions, including Felix's completion of its Series A financing.
- Worldwide Joint Development Agreement with Augmenta Bioworks: On November 2, TFF announced that it had entered into a worldwide joint development and collaboration agreement with Augmenta Bioworks of Menlo Park, CA to develop novel commercial products incorporating Augmenta's human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics. These products will be developed utilizing TFF Pharmaceutical's Thin-Film Freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to the lungs of patients. Under the Agreement, TFF Pharmaceuticals will also have an option to develop an additional Augmenta mAb for indications other than COVID-19.
- University of Georgia Universal Influenza Vaccines: In October, TFF reported positive preclinical immunogenicity and efficacy data from a UGA-developed universal Influenza hemagglutinin (HA) recombinant vaccine that had been reformulated using the Company's Thin Film Freezing process. The Company reported that this reformulated, dry powder HA vaccine elicited equivalent neutralizing antibodies and protection against influenza virus infection compared to liquid formulations. In April of 2020, TFF Pharmaceuticals and the University of Georgia's Center for Vaccines and Immunology entered into a Research and Development Agreement to test the immunogenicity and efficacy of universal influenza HA recombinant vaccines following the TFF process.
- Tacrolimus Inhalation Powder: The Company reported successfully completing the single ascending dosing of four cohorts of healthy subjects in its Phase 1 trial of Tacrolimus Inhalation Powder. The dosing completed to date suggests that Tacrolimus Inhalation Powder is well tolerated with no reports of clinically significant drug-associated adverse events and provide substantial systemic blood levels, from just a single dose, that approach those levels associated with effective immunosuppression in heart, lung, kidney and liver transplant patients. Tacrolimus is an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection.
- Voriconazole Inhalation Powder: TFF's lead clinical program, Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA, successfully completed the clinical portion of its Phase 1 trial and progressed to Phase 2. Top-line data from the Phase I single ascending dose and multiple ascending dose portions of the trial indicated that when dosed up to 80mg twice daily, Voriconazole Inhalation Powder showed no signs of the clinically significant hepatic or visual toxicities that were previously reported for the oral or intravenous forms of voriconazole. Phase 2 studies will assess the efficacy of the dry powder formulation for the treatment of IPA.
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COVID-19/SARS-CoV-2 Drug Repurposing Feasibility Projects: TFF is actively reviewing previously FDA approved drugs that may be repurposed to combat the novel coronavirus behind the COVID-19 pandemic outbreak. The Company is reviewing libraries of compounds that could potentially benefit from the characteristics of the TFF technology in developing a dry powder product delivered directly to the lung that is capable of targeting SARS-CoV-2 and potentially similar viruses such as SARS-CoV, MERS-CoV and other endemic coronaviruses.
During the quarter, the inventor of the Company's TFF technology, Dr. Robert O. (Bill) Williams III, published new animal pharmacokinetics data evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing. Top-line results of the study conducted by Dr. Williams' team of researchers at the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery, concluded that TFF technology can produce high potency remdesivir dry powder formulations for inhalation suitable to treat patients with COVID-19 on an outpatient basis and earlier in the disease course where effective antiviral therapy can reduce related morbidity and mortality.
- Worldwide Licensing Agreement with UNION Therapeutics: As announced previously during the quarter, on August 12, 2020, the Company signed a worldwide exclusive licensing agreement with UNION Therapeutics for its Thin Film Freezing technology used in combination with niclosamide.
- Private Financing Round: As announced previously on August 13, 2020, the Company closed on a private placement of up to $25,913,550, before deducting placement agent and other offering expenses, of common shares of the Company. Net proceeds from the financing are being used to accelerate the expansion of the Company's internal development portfolio beyond its programs for Voriconazole and Tacrolimus inhalation powders.
Financial Results
For the nine months ended September 30, 2020, compared to the prior year
- Research and Development (R&D) expenses: R&D expenses for the nine months ended September 30, 2020 were $7.6 million, compared to $5.6 million for the same period in 2019.
- General & Administrative (G&A) expenses: G&A expenses for the nine months ended September 30, 2020 were $5.1 million, compared to $1.7 million for the same period of 2019.
- Net Loss: TFF Pharmaceuticals reported a net loss for the nine months ended September 30, 2020 of $12.7 million, compared to a net loss of $7.2 million for the same period of 2019.
- Shares Outstanding: Weighted average common shares outstanding, basic and diluted, for the nine months ended September 30, 2020 were 20,810,004, compared with 4,400,000 for the same period in 2019.
- Total Assets: As of September 30, 2020, we had total assets of approximately $43.2 million and working capital of approximately $40.6 million. At the end of the quarter, our liquidity included approximately $41.6 million of cash and cash equivalents.
- Shelf-registration statement on Form S-3: On November 5, TFF Pharmaceuticals filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission for future offerings of up to $100 million of the Company's common stock.
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 42 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 versions of Voriconazole and Tacrolimus, the recent agreements with Augmenta Bioworks and Felix Technology, the potential license of our technology to UNION therapeutics and the Company's plans to add to its existing pipeline of product candidates and license its technology to other third-parties. 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) the risk that results obtained in dry powder formulation and in vitro testing of the Company's product candidates may not be indicative of results obtained in future preclinical or clinical trials; (ii) the risk that the Company's dry powder formulation of its product candidates may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its product candidates; (v) the risk that the Company's agreements with Felix Technology and UNION will not lead to definitive license agreements; (vi) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product; (vii) 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 (viii) those other risks disclosed in the section "Risk Factors" included in the Company's 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
Three Months
Ended
September 30,
2020Three Months
Ended
September 30,
2019Nine Months
Ended
September 30,
2020Nine Months
Ended
September 30,
2019Operating expenses:
Research and development
$
2,823,669
$
2,563,528
$
7,626,982
$
5,554,046
General and administrative
2,254,912
300,640
5,147,639
1,721,691
Total operating expenses
5,078,581
2,864,168
12,774,621
7,275,737
Loss from operations
(5,078,581
)
(2,864,168
)
(12,774,621
)
(7,275,737
)
Other income:
Interest income
20,546
25,865
102,809
67,699
Total other income
20,546
25,865
102,809
67,699
Net loss
(5,058,035
)
(2,838,303
)
(12,671,812
)
(7,208,038
)
Preferred stock dividend
—
(258,635
)
—
(768,876
)
Net loss applicable to common stock
(5,058,035
)
(3,096,938
)
(12,671,812
)
(7,976,914
)
Other comprehensive loss:
Foreign currency translation adjustments
(28,172
)
—
(67,663
)
—
Comprehensive loss
$
(5,086,207
) $
(3,096,938
) $
(12,739,475
) $
(7,976,914
) Net loss applicable to common stock per share, basic and diluted
$
(0.24
) $
(0.70
) $
(0.61
) $
(1.81
) Weighted average common shares outstanding, basic and diluted
20,867,526
4,400,000
20,810,004
4,400,000
TFF PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30,
December 31,
2020
2019
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
41,617,891
$
28,094,936
Prepaid assets and other current assets
595,016
1,092,462
Total current assets
42,212,907
29,187,398
Property and equipment, net
945,365
—
Total assets
$
43,158,272
$
29,187,398
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
1,573,384
$
410,638
Total current liabilities
1,573,384
410,638
Accrued research and development expense
—
1,132,013
Total liabilities
1,573,384
1,542,651
Commitments and contingencies
Stockholders' equity:
Common stock; $0.001 par value, 45,000,000 shares authorized; 22,226,284 and 18,450,992 shares
issued and outstanding as of September 30, 2020 and December 31, 2019, respectively22,226
18,451
Additional paid-in capital
70,014,551
43,338,710
Accumulated other comprehensive loss
(67,663
)
—
Accumulated deficit
(28,384,226
)
(15,712,414
)
Total stockholders' equity
41,584,888
27,644,747
Total liabilities and stockholders' equity
$
43,158,272
$
29,187,398
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105006034/en/
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Felix Biotechnology would obtain worldwide license for Thin Film Freezing technology to develop a novel, bacteriophage-based biotherapeutic
Proposed terms provide for upfront payments, clinical development milestone and commercial milestone payments to TFF Pharmaceuticals of up to $281 million, as well as negotiated royalty payments
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, and Felix Biotechnology, Inc., a clinical stage, biotherapeutic-based antibiotic development company, today jointly announce that both companies have entered into a letter of intent (LOI) which reflects the parties' non-binding agreement in principle to negotiate and enter into a Collaboration, Development and License Agreement (CDLA).
Under this proposed CDLA agreement, Felix Biotechnology would obtain a worldwide license to TFF Pharmaceuticals' Thin Film Freezing technology to develop and manufacture dry powder formulations of a novel, bacteriophage-based biotherapeutics for inhalation delivery directly to the lungs of patients. Under the terms of the proposed CDLA and in exchange for the license to the TFF technology, Felix would agree to pay TFF Pharmaceuticals an upfront payment, development milestones, commercial milestones and royalties on net sales of the Felix biotherapeutics. A definitive CDLA is subject to the mutual agreement of the parties and a number of conditions, including Felix Biotechnology's successful completion of a Series A financing.
"We are very excited to be pursuing an agreement with Felix Biotechnology, a company on the leading edge of developing bacteriophage therapies that initially are targeting bacterial lung infections," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "We believe the reformulation of these unique, complex biologics using our TFF technology would represent a first-of-its-kind breakthrough and could provide a more effective and targeted delivery mechanism to the deep lung of patients. We look forward to working towards a final agreement and seeing this breakthrough technology advance into the clinic and beyond."
"Our goal at Felix is not only to develop but also to deploy innovative solutions to tackle the growing and unmanaged challenge of antibiotic resistant bacterial infections. We currently deliver our generalized phage therapy directly to the lung via nebulization, and have done so successfully in humans. Our lead asset, targeting Pseudomonas infections in the lungs of CF patients is currently being evaluated in a double-blind, placebo-controlled trial at Yale in 36 patients," said Rob McBride, CEO of Felix Biotechnology. "We are excited to continue developing cutting edge and effective phage delivery solutions to our patients and our collaboration with TFF represents an important next step for us on this path."
"Bacteriophages, which are bacterial viruses that infect specific strains of a single bacteria species, are highly relevant as therapeutic alternatives to antibiotics because of the prevalence of multidrug resistance to antibiotics," said Robert O. Williams III, Division Head of the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery and an inventor of TFF Pharmaceutical's Thin Film Freezing technology.
"The challenge, historically, of delivering bacteriophages is that their formulations have not been well optimized, limiting their shelf-life and subsequent potency. Many of these formulations also require cold-chain storage," continued Williams. "We have demonstrated that Thin Film Freezing can convert liquid bacteriophage into a dry powder that can be stored at typical room temperatures. This dry powder form of the bacteriophage can then be administered by intranasal/inhalation delivery to the lungs, or by injection after reconstitution at the point-of-use."
In May of 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Felix Biotechnology supplied various phage product materials to TFF Pharmaceuticals for compatibility and feasibility testing. TFF Pharmaceuticals was successful in formulating dry powder formulations of the Felix phage products, which exhibited superior aerosol properties for lung delivery. Based on this successful formulation work and confirmatory in-vitro testing, which included titer testing and neutralization testing, both parties agreed to begin negotiating a licensing arrangement.
About Felix Biotechnology, Inc.
Felix Biotechnology is a clinical stage, biotherapeutic-based antibiotic development company with technology from Yale University and UC Berkeley, focused on accelerating the development and deployment of non-traditional biotherapeutic-based antibiotics targeting urgent microbial challenges in patients who can't wait. Their engineering and discovery platforms generate therapies that overcome key limitations of traditional phage therapy approaches (bacterial resistance and phage specificity). This allows for the deployment of generalized phage therapy that kill specific bacterial infections while preserving healthy microbiome function. For more information, please visit our website at https://www.felixbt.com, or follow us on Twitter at https://twitter.com/felixbiotech.
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 42 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 nonbinding letter of intent with Felix Biotechnology, the proposed negotiation and execution of a definitive Collaboration, Development and License Agreement (CDLA), the potential success of the proposed collaboration between TFF and Felix Biotechnology, TFF's potential receipt of milestone and sales-based payments from Felix Biotechnology, the benefits of the Company's TFF platform and its dry powder formulations of niclosamide and other materials, and the Company's plans to add to its existing pipeline of product candidates and license its technology to third-parties. 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) the risk that TFF Pharmaceuticals may not be able to conclude a CDLA with Felix Biotechnology; (ii) if the parties can conclude a CDLA, the risk that results obtained in dry powder formulation and in vitro testing of the Felix phage products may not be indicative of results obtained in future preclinical or clinical trials; (iii) the risk that TFF Pharmaceuticals' dry powder formulation of the Felix phage products may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iv) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (v) the risk that TFF Pharmaceuticals and Felix Biotechnology may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of the Felix phage products, , (vi) the risk that few, or none, of the milestone or sales and sales-based payments from Felix Biotechnology will be satisfied and TFF will receive little, or none, of such milestone and sales-based payments, (vii) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (viii) 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 (ix those other risks disclosed in the section "Risk Factors" included in the Company's 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105006041/en/
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Companies to collaborate in first-of-its-kind uses of Thin Film Freezing technology applied to monoclonal antibodies
TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, and Augmenta Bioworks, Inc., a biotechnology company enabling breakthroughs in medicine through immune profiling, today jointly announce that both companies have entered into a worldwide Joint Development and Collaboration Agreement to develop novel commercial products incorporating Augmenta's human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics.
Under the terms of the Agreement, both companies will collaborate in a Joint Development Project to develop one or more commercial therapeutics based on, derived from, and/or incorporating Augmenta's human monoclonal antibodies to potentially treat patients with COVID-19. These products will be developed utilizing TFF Pharmaceuticals' Thin-Film Freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to the lungs of patients. The Agreement also includes the development of formulations suitable for parenteral administration, where the Thin Film Freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. TFF Pharmaceuticals will also have the option to develop two additional Augmenta mAbs for indications other than COVID-19.
Augmenta Bioworks and TFF Pharmaceuticals will allocate patent license rights to their respective technologies to allow each company to jointly commercialize the products developed under the Joint Development Project. The companies have agreed to a 50-50 split of all costs and expenses to further the Joint Development Project and both companies have agreed to the same 50-50 split of all revenues, cash payments and/or future cash payments related to the sale and/or license of the products resulting from the Joint Development Project to a third party.
"This important agreement represents the culmination of many months of work by our scientific team, as we work towards the development of a never-before-achieved formulation of monoclonal antibodies into a dry powder therapeutic," said Glenn Mattes, CEO, of TFF Pharmaceuticals, Inc. "It is a testament to the remarkable flexibility and capability of our Thin Film Freezing platform and we are eager to develop these potentially breakthrough mAb therapies internally, along with our other programs in Invasive Pulmonary Aspergillosis, solid organ transplant anti-rejection, and botanicals."
"Confirmed discovery of novel anti-SARS-Cov-2 antibodies in 8 days was an achievement made possible by years of technology development, and a clear indication of the power and potential of our platform," said Christopher Emig, Ph.D., CEO and Co-Founder of Augmenta Bioworks, Inc. "We are excited to enter this partnership to bring our COVID-19 treatment into clinical development, and are looking forward to the world's first effective, affordable and scalable antibody therapeutic to mitigate the devastating effects of this disease."
"We believe the interest in monoclonal-antibody therapeutics for the treatment of COVID-19 is extremely high, with the promise that they will harness the immune system's natural response to viral invaders," said Robert O. Williams III, Ph.D., Division Head of the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF Pharmaceuticals' Thin Film Freezing technology.
"The challenge becomes in the delivery of these very large, complex molecules via injection, which does not reach directly to the initial site of infection - the deep lung area. Liquid injections are also subject to all the attendant difficulties of cold chain handling and storage, potentially limiting their use to only areas in the developed world," continued Williams. "In this collaboration with Augmenta, the first-of-its-kind use of Thin Film Freezing technology applied to monoclonal antibodies has the potential to mitigate both of these challenges and lead to a therapy that is more effective and easier to deliver to a global community."
In June 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Augmenta Bioworks supplied various mAb product materials to TFF Pharmaceuticals for compatibility and feasibility testing. TFF Pharmaceuticals was successful in formulating dry powder formulations of the Augmenta mAbs, which exhibited superior aerosol properties for lung delivery. Based on this successful formulation work and confirmatory in-vitro testing, which included viability testing, binding testing and neutralization testing, both parties agreed to pool their efforts and resources through a Joint Development Project, and collectively move the dry powder mAb products into pre-clinical and toxicology studies with the goal of further advancement of these dry powder mAbs into human testing in the clinic.
About Augmenta Bioworks
Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its DeepGridTM and SingleCyte® Technologies, Augmenta profiles human immunity at unprecedented scale and speed, shrinking new drug discovery timelines from years to days. The company's platform utilizes the latest software, automation, microfluidics, high throughput DNA sequencing, and scalable computational analysis to identify immune receptors and their antigen specificity. The results are therapeutics derived from natural human immunity. The company works through partnerships in antibody discovery (infectious disease), cell therapy development (oncology), and other advanced research (auto-immunity).
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 42 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 versions of Voriconazole and Tacrolimus, the potential development of one or more dry powder mAbs through its collaboration with Augmenta Bioworks and the Company's plans to add to its existing pipeline of product candidates and license its technology to other third-parties. 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) the risk that results obtained in dry powder formulation and in vitro testing of the Augmenta mAbs may not be indicative of results obtained in future preclinical or clinical trials; (ii) the risk that TFF Pharmaceuticals' dry powder formulation of the Augmenta mAbs may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that TFF Pharmaceuticals and Augmenta may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of the Augmenta mAbs, (v) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) TFF Pharmaceuticals has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vi) those other risks disclosed in the section "Risk Factors" included in the TFF Pharmaceuticals' 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201102005519/en/
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Company to hold conference call and webcast at 4:30 PM EDT
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 that it will release its financial results and business update for the third quarter of 2020 on Thursday, November 5, 2020 at the close of the U.S. financial markets.
Management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 4:30 PM Eastern Time. A question and answer session with investors will follow management's remarks.
Conference Call Details:
Thursday, November 5, 2020, 4:30 PM Eastern Time (ET)
Domestic Dial-In Number: Toll-Free: (877) 784-1702
International Dial-In Number (857) 770-0110
Conference ID: 9498042
Webcast Registration Link: https://edge.media-server.com/mmc/p/wiw3v2y6
Please access the Webcast Registration Link at least 15 minutes ahead of the Conference to register, download, and install any necessary audio software.The conference call will also be available for replay for one month on the Company's website, https://tffpharma.com, in the Events Calendar of the Investors section.
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 Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 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.View source version on businesswire.com: https://www.businesswire.com/news/home/20201028005634/en/