TFFP TFF Pharmaceuticals Inc - Ordinary Shares
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Voriconazole Inhalation Powder
Asthma
|
Phase 1b
Phase 1b
|
Phase 1b trial initiation announced December 15, 2020.
|
|
Tacrolimus Inhalation Powder
Lung transplant (post)
|
Phase 1
Phase 1
|
Phase 1 topline results demonstrated safety profile and demonstrating therapeutic drug levels can be achieved at low doses. Phase 2 trial to begin 4Q 2021.
|
|
Voriconazole Inhalation Powder
Invasive Pulmonary Aspergillosis (IPA)
|
Phase 2
Phase 2
|
Phase 2 trial planned for 4Q 2021.
|
Latest News
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Results published in bioRxiv Show That Delivery of Dry Powder AUG-3387 Following Viral Inoculation Led to Dose-Dependent Reduction in Lung Viral Load in Hamsters
Dry Powder Formulations Show Equivalent Binding as Original Antibody with No Loss of Biologic Activity
Study Indicates AUG-3387 Binds to Both Lambda and Mu Variants of SARS-CoV-2
AUSTIN, Texas and MENLO PARK, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) -- 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 Augmenta Bioworks, a biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine, today announced the publication of a research paper highlighting positive preclinical study results of AUG-3387, a monoclonal antibody (mAb) therapy being developed in collaboration between the two companies for the treatment of SARS-CoV-2 infection. The findings have been published online through the bioRxiv preprint server, under the title "AUG-3387, a Human-Derived Monoclonal Antibody Neutralizes SARS-CoV-2 Variants and Reduces Viral Load from Therapeutic Treatment of Hamsters In Vivo."
The AUG-3387 mAb was formulated as a dry powder using TFF Pharmaceuticals' proprietary Thin Film Freezing process to enable direct delivery to the lungs and remove the need for intravenous infusion that is required for delivery of current COVID-19 antibody therapies. AUG-3387 was isolated using the SingleCyte® platform developed at Augmenta Bioworks. SingleCyte® rapidly profiles human immunity to discover antigen-specific antibodies using AI driven single cell imaging and retrieval technology.
Delivery of the dry powder formulation of AUG-3387 to infected hamsters resulted in a dose-dependent reduction of viral load when administration of the mAb was initiated 24 hours after infection with SARS-CoV-2. Previous mAbs that have received Emergency Use Authorization from the FDA for treatment of COVID-19 have only reported efficacy in the hamster model when the mAbs were delivered prophylactically 24 hours before infection with SARS-CoV-2. This study also represents the first report of successful reduction of viral load using inhaled delivery of a dry powder monoclonal antibody therapeutic for COVID-19 disease. The results suggest that AUG-3387 represents a viable opportunity to improve on current approved COVID-19 antibody treatments through convenient at-home administration, direct delivery to the lungs and distribution worldwide without requiring cold-chain storage.
In addition to the in vivo efficacy, AUG-3387 also showed binding activity against the Alpha, Beta, Delta, Gamma, Kappa, Lambda and Mu variants of SARS-CoV-2. Robust binding to all tested strains of SARS-CoV-2 suggests AUG-3387 targets a highly conserved region of the virus, making AUG-3387 likely to remain effective despite the frequent emergence of new variant strains.
"We are very excited to publish these additional results from our monoclonal antibody program in development with Augmenta, which demonstrate how we can apply our Thin Film Freezing technology to formulate monoclonal antibodies into an inhaled dry powder without changing the underlying biologic properties of the molecule itself," said Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. "We completed this study as quickly and efficiently as possible knowing the urgent need for new COVID-19 treatments, but adhered to a rigorous model to ensure accurate assessment of our dry powder formulation of AUG-3387. Unlike prior in vivo studies of currently approved COVID-19 antibody therapies that failed to show viral load reduction in animals when delivered after inoculation with the SARS-CoV-2 virus, AUG-3387 demonstrated the ability to reduce viral load in a dose-dependent manner after the animals had been fully inoculated. In our view, AUG-3387 is fast emerging as one of the most promising new therapeutics for the treatment of COVID-19."
Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV-2 who are at a high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV-2 infection for individuals who are at a high risk for severe disease. With the completion of in vivo preclinical efficacy studies, Augmenta and TFF now plan to enter toxicology studies in early 2022 and human clinical trials shortly thereafter. Ongoing formulation development studies are expected to demonstrate that a sufficient dose of AUG-3387 to achieve a neutralizing concentration in the lungs can be delivered via already approved commercial dry powder inhaler devices. TFF and Augmenta are working with Catalent Biologics to conduct cell line development, drug substance manufacturing and scale-up efforts for AUG-3387 as the program advances through clinical development.
"This study confirms the power of Augmenta's SingleCyte® platform to isolate therapeutic antibody candidates with unique functional properties, such as AUG-3387, which broadly neutralizes SARS-CoV-2," added Dr. Christopher Emig, Chief Executive Officer of Augmenta Bioworks. "We continue to be impressed with TFF's Thin Film Freezing platform and the stability of AUG-3387 formulated as a dry powder without any loss of potency. The successful validation of both of our technology platforms in this rigorously designed in vivo study suggests that AUG-3387 could play a key role in the ongoing global need for distribution of shelf-stable, highly effective COVID-19 antibody treatments."
In prior in vitro preclinical testing, AUG-3387 effectively neutralized SARS-CoV-2 and demonstrated activity against other major COVID variants of concern, including the previously identified Delta variant (B.1.617.2) Alpha variant (B.1.1.7), Beta variant (B.1.351), Gamma variant (P.1) and Kappa variant (B.1.617.1). The additional positive data demonstrating activity against Lambda and Mu variants validates Augmenta's discovery approach and reflects TFF and Augmenta's ongoing commitment to develop a therapy that is effective against emerging variant strains of SARS-CoV-2.
About the Development Agreement Between Augmenta Bioworks and TFF Pharmaceuticals
In November 2020, Augmenta Bioworks and TFF Pharmaceuticals announced establishment of 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. TFF Pharmaceuticals also obtained the option to develop two additional Augmenta mAbs for indications other than COVID-19. These antibodies are expected to be developed utilizing TFF Pharmaceuticals' Thin Film Freezing technology to manufacture dry powder formulations 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.About Augmenta Bioworks
Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its DeepGrid™ and SingleCyteR 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 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.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 AUG-3387, 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) the risk that the Company and Augmenta Bioworks may not be able to successfully conclude clinical testing or obtain pre-market approval of a dry powder version of AUG-3387, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section "Risk Factors" included in the Company's 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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.
Company Contacts:Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
gmattes@tffpharma.com
737-802-1973Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358Christopher Emig, Ph.D.
CEO
Augmenta Bioworks, Inc.
info@augbio.com
650-731-2842Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.comMedia Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.comSource: TFF Pharmaceuticals, Inc.
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AUSTIN, Texas, Sept. 23, 2021 (GLOBE NEWSWIRE) -- 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 topline results from the recently completed Phase 1 clinical trial for Tacrolimus Inhalation Powder showing a promising safety profile and demonstrating therapeutic drug levels can be achieved at low doses.
Among the approximately 4,000 lung transplantation procedures performed each year worldwide, high tacrolimus blood concentrations are common and known to be associated with Acute Kidney Injury (AKI) that can progress to Chronic Kidney Disease (CKD)1,2. Inhaled Tacrolimus Powder, which is delivered directly to the lung, offers a potentially attractive option for lung transplantation patients by maintaining higher concentrations at the site of the graft while not exposing other organs to supra-therapeutic plasma levels that are well known to cause renal damage in a substantial portion of these patients.
Therapeutic drug monitoring (TDM) is a routine practice in lung transplant recipients where tacrolimus dosing is continually titrated to maintain plasma concentrations within a narrow therapeutic window. Tacrolimus trough plasma concentrations in a range of 5-15 ng/mL are generally regarded as necessary for effective immunosuppression and a range of 10-15 ng/mL is used in the first year following transplant to minimize rejection3,4. However, the challenge for lung transplant patients is to ensure sufficiently high local concentrations of tacrolimus are maintained in the lung to prevent acute allograft rejection without inducing renal toxicity.
"The data from this Phase 1 study suggests that Tacrolimus Inhalation Powder can be administered with an acceptable safety profile to achieve the appropriate balance of local and systemic concentrations for immunosuppression at the site of the lung transplant while minimizing the risk of supra-therapeutic systemic exposure well known to cause substantial renal toxicity in these patients," said Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. "We believe the strong dose-dependent PK data with pulmonary administration will allow a flexible dosing regimen that can be tailored to each patient, consistent with the manner in which these patients are managed in the real-world setting. This flexible dosing approach will also be reflected in the design for our upcoming Phase 2 study in lung transplant recipients."
The trial was conducted with the standard format for a Phase 1 program:
- A single ascending dose (SAD) phase with single inhalation doses of Tacrolimus Inhalation Powder of 0.5 mg, 1 mg, 2.5 mg and 5 mg was administered to four cohorts of healthy volunteers. The eight subjects in each cohort included six subjects randomized to receive tacrolimus and two randomized to receive placebo. A total of 24 subjects received active study drug.
- A multiple ascending dose (MAD) phase with three total cohorts. Two cohorts received repeated administration of Tacrolimus Inhalation Powder every 12 hours over 7 days at doses of 0.5 mg and 1.0 mg (BID dosing), and a third cohort received repeated administration of 1.5 mg once daily for seven days (QD dosing). The eight subjects in each cohort included six subjects randomized to receive tacrolimus and two randomized to receive placebo. A total of 18 subjects received active study drug.
Topline pharmacokinetic data from the Phase 1 study included:
- In the SAD phase of the study, inhaled delivery of tacrolimus resulted in mean trough blood levels of 10 ng/mL 12 hours post-dosing for subjects that received a dose of 5 mg, which falls within the desired range for maintenance immunosuppression following lung transplant.
- As previously reported in July, subjects from the MAD phase of the study who received doses of 0.5 mg twice daily and 1.0 mg twice daily achieved 12-hour trough steady state blood levels of tacrolimus that averaged 6.8 and 14.9 ng/mL, respectively, demonstrating that Inhaled Tacrolimus Powder can achieve blood levels generally deemed to be sufficient for efficacious immunosuppression.
- New data reported today showed that once daily dosing with 1.5 mg of Inhaled Tacrolimus Powder resulted in mean 12-hour trough blood levels of 6.3 ng/mL and mean 24-hour trough blood levels of 4.8 ng/mL, consistent with the desired therapeutic ranges for lung transplant patients.
The company is confident that this collective range of dose options has the potential to provide the flexibility for effective management of lung transplant patients in keeping with the current standard of practice that uses TDM to maintain appropriate plasma concentrations of tacrolimus.
TFF Pharmaceuticals expects to take critical steps toward beginning its Phase 2 clinical study of Inhaled Tacrolimus Powder by the end of 2021. The goal of the Phase 2 study, which will be an open-label study conducted in lung transplant patients who are experiencing kidney toxicity, is to test the hypothesis that Inhaled Tacrolimus Powder can provide adequate systemic exposure while maintaining higher drug levels in the lung, thereby reducing the risk of acute allograft rejection and improving symptoms of renal toxicity. Patients currently receiving oral tacrolimus will transition to a flexible dosing regimen of inhaled tacrolimus. The inhalation dose will be able to be adjusted weekly to achieve the desired blood level assigned by each patient's physician and ongoing biomarker-based assessments.
"It is exciting for our patients and for us as clinicians to have a potential new option with Inhaled Tacrolimus Powder. Inhaled tacrolimus may be able to help overcome multiple current limitations we encounter with therapy and could optimize the management of acute allograft rejection in lung transplant recipients," said Deborah Jo Levine, M.D., Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and Medical Director of Lung Transplantation and Director of the Pulmonary Hypertension Center with the UT Health San Antonio Long School of Medicine. "In addition to concerns about systemic toxicities including kidney injury, oral administration of tacrolimus is often challenging for patients to manage with multiple adjustments. We currently have a lack of innovative therapies in this space and these studies reveal some of the most exciting results we have seen in the lung transplantation field. I look forward to seeing how inhaled tacrolimus performs in the next stage of development when utilized in lung transplant recipients."
Safety results from the Phase 1 trial included:
- In both phases of the trial, the reported adverse events (AEs) were generally mild and consistent with those known to be related to tacrolimus exposure. There was no evidence of decreased pulmonary function, and based on the ECG assessments administered to all subjects, there were no instances of QTc prolongation (a known effect of tacrolimus).
- In the SAD portion of the study, no serious adverse events (SAEs) occurred. The most common side effects were mild and included headache, altered taste, throat irritation, and chest tightness.
- In the MAD portion of the trial, four patients experienced mild hypomagnesemia, a known adverse effect of tacrolimus. All four patients were in the 1.0 mg BID dosing cohort. Importantly, three of the four subjects had 12-hour trough blood levels of tacrolimus that exceeded the upper limit of the optimal range for lung transplant patients (15 ng/mL). All four patients, after receiving magnesium supplementation, had their magnesium levels return to baseline.
- Other mild AEs in the MAD portion of the study included headache, altered taste, throat irritation, and chest tightness. One subject experienced a headache with moderate severity that was deemed unrelated to study medication.
- A single Serious Adverse Event (SAE) was reported as possibly drug-related in a subject in the 1.5 mg QD dose cohort of the MAD phase of the study. The subject experienced confusion approximately 3.5 hours after receiving the seventh dose. The effects resolved spontaneously within 30 minutes and the subject was not admitted to hospital. During this event, no abnormal lab results, ECG traces, or physical exam results were found. This, combined with the transient nature and spontaneous resolution without changes in drug concentrations, leads to an unclear relationship between the drug and the adverse event. A review by the safety management committee concluded that it was safe to continue dosing the remainder of the cohort.
1. Eur J Clin Pharmacol. 2017; 73(5): 573–580.
2. International Society for Heart & Lung Transplantation (ISHLT.org)
3. Ann. Thorac. Med.; Jul-Sep 2019;14(3):186-191
4. University of Pittsburgh Medical Center; Lung Transplant Management Guidelines; August 2016About 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.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 Tacrolimus, 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) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Tacrolimus, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section "Risk Factors" included in the Company's 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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.Company Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc.
gmattes@tffpharma.com
737-802-1973Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.comMedia Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.comSource: TFF Pharmaceuticals, Inc.
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AUSTIN, Texas, Sept. 08, 2021 (GLOBE NEWSWIRE) -- 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 President and CEO Glenn Mattes will present a corporate overview at 23rd H.C. Wainwright Annual Global Investment Conference being held from September 13-15th, 2021.
Details on the presentation can be found below:
Presentation date: available on-demand starting at 7:00 a.m. ET on September 13, 2021
Webcast link: https://journey.ct.events/view/4a77d813-2d0d-4ffe-9b6d-920b5962e6e5
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 58 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.Company Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
gmattes@tffpharma.com
737-802-1973Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.comMedia Contact:
Gwendolyn Schanker
LifeSci Communications
269-921-3607
gschanker@lifescicomms.comSource: TFF Pharmaceuticals, Inc.
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Additional Data Readouts and Initiation of Pivotal Trials for Inhaled Tacrolimus and Voriconazole Programs Expected in 2H 2021
Multiple Ascending Dose (MAD) Study Demonstrates Inhaled Tacrolimus Inhalation Powder Achieves Blood Levels Sufficient for Efficacious Immunosuppression
Formation of Scientific Advisory Board to Enable Continued Innovation and Clinical Development
Partnerships with Pharma, Academic Institutions and Government Continue to Advance
Conference Call and Webcast Scheduled Today, Thursday, August 12, 2021, at 4:30pm EDT
AUSTIN, Texas, Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2021, and also provided an update on recent corporate and clinical developments. The Company will discuss the clinical, corporate and financial highlights on a conference call and webcast, scheduled today, Thursday, August 12, 2021, at 4:30pm EDT.
"As we advance both our internal programs and external partnerships, TFF Pharmaceuticals continues to demonstrate the transformative potential of our proprietary Thin Film Freezing (TFF) drug delivery platform to improve upon pharmacokinetic and clinical profiles of currently approved therapies, while also formulating novel small molecule and biologic-based therapeutics that address serious unmet medical need," said Glenn Mattes, President and CEO of TFF Pharmaceuticals.
"During this quarter, we announced data from a multiple ascending dosing study showing that our Inhaled Tacrolimus Powder has superior bioavailability as compared to the oral dosage form of tacrolimus, and that relatively low doses as compared to the oral dosage form were able to generate blood concentration levels of tacrolimus known to be sufficiently immunosuppressive in preventing organ rejection following lung transplants. Our toxicology studies demonstrated that the lung concentrations are three- to four-fold higher than blood concentrations and together these data suggest that we can achieve sufficient drug levels in the lung to prevent rejection, while at the same time, mitigating the potential for renal toxicity. We believe this improved pharmacokinetic profile could result in superior safety compared to the oral product without sacrificing efficacy."
Mr. Mattes continued, "I am also pleased to report that our internal CMC and drug manufacturing projects remain on track to fully support our product supply needs for our planned pivotal trials for Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder. Our TFF-TAC program represents a potential significant advancement in a field that has seen very little innovation in decades, and we look forward to presenting additional data for this program later in the year."
"We are also excited to announce significant advances on the partnering front. Most recently, TFF and its partner, Augmenta Bioworks, announced the selection of a lead monoclonal antibody, AUG-3387, which is being developed for the prevention and treatment of COVID-19 and, importantly, has been shown to effectively neutralize the Delta variant in in vitro studies. The relationship with Augmenta is a prime example of how our Company's Thin Film Freezing technology can be applied to proprietary, biologic-based therapeutics addressing a large unmet medical need in public health. This remains a highly active area of collaboration and partnerships for our company, as we now have in place several programs focused on the application of our TFF technology to biologic drugs."
Importantly, all of our pharmaceutical company partnerships continue to advance, which include collaborations with Union Therapeutics Felix Therapeutics, GreenLight Biosciences, NeuroRx, PLUS Products, and Felix Biotechnology. In addition, we currently have ongoing projects with the majority of the top 20 pharmaceutical companies, where we are applying our thin film freezing technology to their products, and in some cases, working on multiple product formulation opportunities for individual companies. In addition, our academic and government partnerships and contracts are progressing and producing meaningful new data."
"Results in the second half should further advance preclinical and clinical progress on both internal and partnered programs as well as generate material new business development opportunities. We believe these anticipated results will reinforce the applicability of TFF's proprietary technology for the use in improving human health across a number of therapeutic areas."
He continued, "As a result of our continued progress across these programs, we have also made key leadership appointments to support both our manufacturing operations and the expansion of our government/academic institution partnership team.
"I am also delighted to announce the formation of TFF's Scientific Advisory Board, a group of extraordinarily accomplished individuals who will impart a wealth of invaluable scientific and medical expertise as we accelerate multiple programs from early-stage development to advanced clinical testing, both for our proprietary drug programs and our partnered opportunities.
"In the second half of the year, TFF will build on these significant accomplishments as we move our internal programs into pivotal testing. On the business development front, we expect to advance our programs with existing partners, while signing new licensing transactions with pharmaceutical and biotechnology companies."
Conference Call and Webcast Information
The Company will host a conference call today, Thursday, August 12, 2021, at 4:30 pm, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:
Domestic Dial-In Number: Toll-Free: (866) 269-4261
International Dial-In Number (323) 289-6581
Conference ID: 6229028The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals' Website, https://tffpharma.com or directly at http://public.viavid.com/index.php?id=146022. 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 Clinical and Corporate Highlights:
- Voriconazole Inhalation Powder (TFF VORI): As noted on the first quarter update, TFF has successfully completed the first of two dosing cohorts in a Phase 1b reactive airway study, which is evaluating safe dosing of TFF VORI in asthma patients with hyperreactive airways. The safety profile for TFF VORI continues to look favorable, with no serious adverse events reported in these cohorts. Top-line data from the study is expected in the third quarter of 2021. The Company continues preparations for an end of Phase 1 meeting with the FDA, and anticipates this meeting will also be held in the third quarter, after the dosing in this Phase 1b reactive airway study is complete.
Earlier in the year, TFF announced the successful completion of the Phase 1 clinical trial and final data for Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA). Based on the results of the Phase 1 trial, the Company will study the 80 mg dose of Voriconazole Inhalation Powder for the upcoming pivotal trial where it will be compared to the oral form of voriconazole. The Company expects to initiate a pivotal trial of TFF VORI in the fourth quarter of 2021, which will be designed to assess efficacy for treating patients with IPA or for preventing infection in patients at high risk for developing IPA infections.
- Tacrolimus Inhalation Powder (TFF TAC): In July, the Company announced completion of enrollment and preliminary data from its Phase 1 trial of Tacrolimus Inhalation Powder (TFF TAC). In the Single Ascending Dose (SAD) phase of the trial, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects. In the subjects that received inhaled tacrolimus in the low dose group, the mean trough blood levels reached 1.1 ng/mL, while blood levels in the highest dose group reached 10.0 ng/mL. Following lung transplant, it is desirable for patients to achieve maintenance tacrolimus blood levels from 5-15 ng/mL to prevent acute allograft rejection.
In addition, when subjects received inhaled tacrolimus dosing at 2.5 mg while fasting or 30 minutes after a high-fat meal, there were no significant differences in systemic exposure demonstrating that delivery by inhalation was not associated with food effects in this cohort of subjects. By contrast, the rate and extent of absorption of tacrolimus is significantly decreased when tacrolimus is administered orally when taken with food, and this effect is most pronounced after a high-fat meal.
In the Multiple Ascending Dose (MAD) phase, repeated dosing of inhaled tacrolimus every 12 hours over 7 days demonstrated that subjects receiving doses of 0.5 mg twice daily and 1.0 mg twice daily achieved 12-hour trough steady state blood levels that averaged 6.8 and 14.9 ng/mL, respectively. Importantly, these data demonstrate that low dosing of Tacrolimus Inhalation Powder (0.5-1.0 mg) can achieve blood levels that are believed to be sufficient for efficacious immunosuppression.
TFF Pharmaceuticals expects to report top-line safety data in the third quarter of 2021 and believes the strong bioavailability data will enable initiation of a clinical trial in lung transplant patients in the second half of 2021. The Company expects that the dosing regimen for the study in lung transplantation will be tailored to potentially provide effective immunosuppression in the lung while reducing renal toxicities.
In June, TFF Pharma held a Science Day for investors, featuring key opinion leader (KOL) perspectives on Thin Film Freezing applications, with a focus on TFF Tacrolimus for lung transplant and TFF approaches to improving vaccines. Deborah Jo Levine, M.D., from UT Health San Antonio, provided background on lung transplantation, the current toxicity limitation of oral tacrolimus for immunosuppression, and the potential improvements with an inhaled formulation of tacrolimus (TFF TAC). Kartik Chandran, Ph.D., from the Albert Einstein College of Medicine, discussed the benefits of using the TFF technology to create a dry powder pulmonary formulation for the rVSV vaccine against COVID-19. Ted Ross, Ph.D., from the University of Georgia, discussed his experience utilizing the TFF process for creating a universal influenza vaccine for pulmonary delivery and its potential benefit over the existing annual vaccination. TFF Pharma's management team also provided an update on its internal pipeline and several upcoming planned clinical data releases for TFF TAC and TFF VORI (treatment of invasive fungal infections). The event and its presentation materials can be found on the TFF corporate website.
- Strategic Business Development and Partnership Activities – Governmental and Defense Contracting Agencies: Early in the second quarter, TFF announced that it is was awarded a contract with Leidos to participate in the Personalized Protective Biosystems (PPB) Program to develop next-generation chemical and biological protection for U.S. warfighters and stability operators. The PPB research program is overseen by the Defense Advanced Research Projects Agency (DARPA) and aims to develop an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. TFF Pharmaceuticals will utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, eyes and respiratory system.
We continue to engage and collaborate with various government and defense contracting agencies in an effort to utilize the Company's TFF technology platform to formulate dry powder vaccines and therapeutics for delivery via reconstitution for lung or nasal inhalation. This includes our 3-year Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) for biodefense countermeasures, and our early-stage universal influenza work with the University of Georgia's Center for Vaccines and Immunology, part of the NIH's Collaborative Influenza Vaccine Innovation Centers (CIVICs).
- Strategic Business Development and Partnership Activities – Biopharmaceutical Companies and Research Institutions, Cannabis Development and Commercialization: During the second quarter, TFF Pharmaceuticals and its partner, Augmenta Bioworks, selected a lead monoclonal antibody candidate, AUG-3387, for COVID-19. More specifically, Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV2 who are at high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV2 infection for individuals who are at high-risk for severe disease.
In vitro preclinical testing has demonstrated that AUG-3387 effectively neutralizes SARS-CoV2 and has activity against all variant strains tested to date, including major COVID variants of concern: Alpha (B.1.1.7 ), Beta (B1.1.351), Gamma (P.1) and Kappa (B.1.617.1) and Delta (B.1.617.2). TFF and Augmenta have an ongoing commitment to monitor activity of AUG-3387 against emerging SARS-CoV-2 variants and will be completing in vivo preclinical efficacy studies in the coming weeks. Continued scale-up manufacturing of AUG-3387 continues, and the Companies expect completion of toxicology studies to enable human clinical trials in the months ahead.
TFF also continues to work with its partner, PLUS Products, to develop Thin Film Freezing versions of cannabinoid products. PLUS Products is currently conducting consumer testing of specific formulations.
Formation of Scientific Advisory Board
TFF Pharmaceuticals also announced the formation of a Scientific Advisory Board, comprised of globally-recognized thought leaders in their respective fields of study. The SAB will advise TFF Pharmaceuticals across a range of issues, including internally developed programs and select external projects. Below is a list of our advisors and their affiliated institutions:- David N. Cornfield, M.D.
Director of the Center for Excellence in Pulmonary Biology at Stanford, and Chief of the pediatric pulmonary, asthma, and sleep medicine divisions at Stanford University and Lucile Packard Children's Hospital - David Denning, FRCP, FRCPath, DCH, FMedSci
Professor of Infectious Diseases in Global Health, University of Manchester - Anthony Hickey, Ph.D.
Professor Emeritus in Pharmacoengineering and Molecular Pharmaceutics at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill - Jay Peters, M.D.
Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center at San Antonio - Ted M. Ross, Ph.D.
Professor at the University of Georgia in the Animal Health Research Center, Center for Vaccines and Immunology, and the Department of Infectious Diseases - Mike Saag, M.D.
Professor of Medicine at UAB School of Medicine, Director of the UAB Center for AIDS Research and Associate Dean for Global Health. - Drew Weismann, M.D., Ph.D.
Roberts Family Professor in Vaccine Research at the Perelman School of Medicine at the University of Pennsylvania
Financial Results
For the three months ended June 30, 2021, compared to the prior year:
- Research and Development (R&D) expenses: R&D expenses for the second quarter of 2021 were $2.8 million, compared to $2.6 million for the same period in 2020.
- General & Administrative (G&A) expenses: G&A expenses for the second quarter of 2021 were $2.4 million, compared to $1.3 million for the same period of 2020.
- Net Loss: TFF Pharmaceuticals reported a net loss for the second quarter of 2021 of $4.7 million, compared to a net loss of $3.8 million for the same period of 2020.
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 58 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, 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) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and Tacrolimus, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section "Risk Factors" included in the Company's 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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
Three Months
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2021Three Months
Ended
June 30,
2020Six Months
Ended
June 30,
2021Six Months
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2020
Grant revenue$ 1,850 $ — $ 26,165 $ — Operating expenses: Research and development 2,762,170 2,567,771 8,040,422 4,803,313 General and administrative 2,351,007 1,274,803 4,998,422 2,892,727 Total operating expenses 5,113,177 3,842,574 13,038,844 7,696,040 Loss from operations (5,111,327 ) (3,842,574 ) (13,012,679 ) (7,696,040 ) Other income: Other income 441,546 — 672,824 — Interest income 14,069 25,995 29,568 82,263 Total other income 455,615 25,995 702,392 82,263 Net loss $ (4,655,712 ) $ (3,816,579 ) $ (12,310,287 ) $ (7,613,777 ) Net loss per share, basic and diluted $ (0.18 ) $ (0.20 ) $ (0.51 ) $ (0.40 ) Weighted average common shares outstanding, basic and diluted 25,369,144 19,071,658 24,261,032 19,040,134 TFF PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, December 31, 2021 2020 ASSETS Current assets: Cash and cash equivalents $ 52,067,339 $ 35,300,805 Receivable due from collaboration agreement 489,221 — Research and development tax incentive receivable 932,057 — Prepaid assets and other current assets 1,968,726 2,258,229 Total current assets 55,457,343 37,559,034 Property and equipment, net 1,697,038 1,102,808 Total assets $ 57,154,381 $ 38,661,842 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,509,224 $ 1,297,725 Deferred research grant revenue 25,000 24,315 Total liabilities 1,534,224 1,322,040 Commitments and contingencies Stockholders' equity: Common stock 25,372 22,535 Additional paid-in capital 102,301,550 71,648,453 Accumulated other comprehensive loss (116,830 ) (51,538 ) Accumulated deficit (46,589,935 ) (34,279,648 ) Total stockholders' equity 55,620,157 37,339,802 Total liabilities and stockholders' equity $ 57,154,381 $ 38,661,842 Company Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
gmattes@tffpharma.com
737-802-1973Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.comMedia Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.com
- Voriconazole Inhalation Powder (TFF VORI): As noted on the first quarter update, TFF has successfully completed the first of two dosing cohorts in a Phase 1b reactive airway study, which is evaluating safe dosing of TFF VORI in asthma patients with hyperreactive airways. The safety profile for TFF VORI continues to look favorable, with no serious adverse events reported in these cohorts. Top-line data from the study is expected in the third quarter of 2021. The Company continues preparations for an end of Phase 1 meeting with the FDA, and anticipates this meeting will also be held in the third quarter, after the dosing in this Phase 1b reactive airway study is complete.
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AUSTIN, Texas, Aug. 05, 2021 (GLOBE NEWSWIRE) -- 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 President and CEO Glenn Mattes will present a corporate overview at the SNN Virtual Investor Conference being held August 17 – 19, 2021.
Mr. Mattes will deliver his corporate presentation on August 19th from 1:30 – 2:00 pm Eastern Time.
Management will be available for one-on-one meetings to be held throughout the conference.
Investors can register here: REGISTER
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.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, 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) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and Tacrolimus, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section "Risk Factors" included in the Company's 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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.Company Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc
gmattes@tffpharma.com
737-802-1973Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.comMedia Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.com