APLT Applied Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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AT-001 (ARISE-HF)
Diabetic cardiomyopathy (DbCM)
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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AT-007 (ACTION-Galactosemia kids)
Galactosemia
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Phase 1/2
Phase 1/2
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Phase 1/2 trial remains on partial clinical hold as of November 12, 2020.
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ALPN-101
Healthy Volunteers
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Phase 1
Phase 1
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Phase 1 data presented at EULAR June 8, 2020 - well tolerated and exhibited pharmacodynamic activity, enabling Phase 2 development.
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Latest News
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Continued enrollment in the ARISE-HF Phase 3 global registrational study of AT-001 in Diabetic Cardiomyopathy (fatal heart disease affecting ~17% diabetics)
On track to initiate rare disease franchise expansion programs in SORD Deficiency and PMM2-CDG studies in the first half of 2021
Continued collaboration with FDA to restart the ACTION-Galactosemia Kids pediatric study
NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the third quarter ended September 30, 2020.
"In the third quarter we continued to execute on our Diabetic Cardiomyopathy program, with strong enrollment in our ARISE-HF global Phase 3 registrational study, and new data presented on AT-001 mechanism of action and improvement in cardiac energetics," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "As we move towards the end of the year, we'll continue to prepare for new rare disease clinical programs in SORD Deficiency and PMM2-CDG, which we plan to start in 2021. While the delay to our Galactosemia pediatric study has been disappointing to families, we continue to work productively with FDA to restart the trial as soon as possible, and we believe the program will be in a stronger position for approval due to close collaboration with the agency. We thank the Galactosemia community for their continuing support."
Recent Highlights
- Shared data on AT-001 at the American Heart Association scientific sessions demonstrating that AT-001 normalizes cardiac energetics and improves cardiac function in a mouse model of Diabetic Cardiomyopathy (DbCM).
- Executed a licensing and research collaboration agreement with the University of Miami on SORD Deficiency (genetically identified by the Miami clinical team in a May 2020 Nature publication). SORD Deficiency is a debilitating hereditary neuropathy affecting over 3,000 patients in the US.
- The pediatric Galactosemia clinical study (ACTION-Galactosemia kids) remains on partial clinical hold as the Company continues to work collaboratively with FDA to restart the study. The rationale for partial hold is not safety related, and the issues being addressed relate to design and operational aspects of the trial. The Company plans to submit an NDA no later than Q3 2021.
- Presented Data on AT-007 for the Treatment of Galactosemia at the American Society of Human Genetics (ASHG) 2020 Annual Meeting. In October 2020, we presented two poster presentations covering AT-007 in Galactosemia at the ASHG 2020 Annual Meeting. The presentations included animal model efficacy data and adult clinical data on the safety and biomarker efficacy of AT-007.
- Announced Pediatric Rare Disease Designation and Orphan Drug Designation for AT-007 for the treatment of PMM2-CDG. PMM2-CDG is a debilitating rare disease caused by deficiency in the critical enzyme phosphomannomutase-2, required for systemic glycosylation of proteins. PMM2-CDG causes multiple organ failure and severe disability, resulting in approximately 20% mortality in the first four years of life. There are currently no drugs approved to treat PMM2-CDG.
- Presented Data on AT-001 for Treatment of Diabetic Cardiomyopathy at 56th Annual Meeting of the European Association for the Study of Diabetes (EASD). In September 2020, we presented two poster presentations covering AT-001, a next generation aldose reductase inhibitor (ARI), in Phase 3 development for Diabetic Cardiomyopathy at the 56th Annual EASD Meeting. The presentations included data on the safety and specificity of AT-001, as well as data on mechanistic protection from cellular damage during hyperglycemia.
Financial Results
- Cash and cash equivalents and short-term investments totaled $116.5 million as of September 30, 2020, compared with $38.9 million at December 31, 2019.
- Research and development expenses for the three months ended September 30, 2020 were $19.9 million, compared to $7.5 million for the three months ended September 30, 2019. For the three months ended September 30, 2020, the increase of $12.5 million was primarily due to an increase in clinical and pre-clinical expense of $4.6 million, primarily related to the progression of the AT-007 ACTION-Galactosemia adult extension study, the AT-007 ACTION-Galactosemia Kids pediatric registrational study and the AT-001 Phase 3 ARISE-HF clinical study; an increase in drug manufacturing and formulation costs of $7.2 million primarily related to raw material deliveries in support of the 2020 manufacturing campaigns and the completion and release of AT-001 and AT-007 drug product batches; an increase in personnel expenses of $0.2 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.1 million due to new stock option and restricted stock unit grants during the three months ended September 30, 2020; and an increase in regulatory and other expenses of $0.4 million relating to an increase in clinical consulting fees during the three months ended September 30, 2020.
- General and administrative expenses were $10.0 million for the three months ended September 30, 2020, compared to $3.3 million for the three months ended September 30, 2019. For the three months ended September 30, 2020, the increase of $6.7 million was primarily related to the increase in personnel expenses of $1.2 million and an increase in stock-based compensation of $1.0 million due to the increase in headcount, $1.0 million related to an increase in legal and professional fees due to increased operations and costs associated with being a public company, $2.4 million related to the establishment of a commercial department, $0.2 million related to increased insurance costs, and $0.9 million in other expenses relating to increased costs of rent and other office expenses.
- Net loss for the third quarter of 2020 was $29.8 million, or $1.33 per basic and diluted common share, compared to a net loss of $10.7 million, or $0.63 per basic and diluted common share, for the third quarter 2019.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company's lead drug candidate, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric metabolic disease. The Company initiated a pivotal Phase 1/2 clinical trial in June 2019, read out positive top-line biomarker data in adult Galactosemia patients in January 2020 and announced full data from the trial in April 2020. A pediatric Galactosemia study commenced in June 2020. The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as "may," "will," "expect," "anticipate," "plan," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the timing of our NDA submission for potential approval of AT-007, which will include data from the ACTION-Galactosemia Kids trial and the 90-day safety data in adults with Galactosemia, (ii) the design, scope and results of our clinical trials, (iii) the timing of the initiation and completion of our clinical trials, (iv) the likelihood that data from our clinical trials will support future development of our product candidates, and (v) the likelihood of obtaining regulatory approval of our product candidates and qualifying for any special designations, such as orphan drug designation. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Such risks and uncertainties include, without limitation, (i) our plans to develop and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain regulatory approval of our current and future product candidates, (viii) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (ix) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (x) the implementation of our business model and strategic plans for our business and product candidates, (xi) our intellectual property position and the duration of our patent rights, (xii) developments or disputes concerning our intellectual property or other proprietary rights, (xiii) our expectations regarding government and third-party payor coverage and reimbursement, (xiv) our ability to compete in the markets we serve, (xv) the impact of government laws and regulations and liabilities thereunder, (xvi) developments relating to our competitors and our industry, (xvii) the impact of the COVID-19 pandemic on the timing and progress of our ongoing clinical trials and our business in general and (xviii) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902 or
[email protected]rgotpartners.comMedia:
Gleb Sagitov
[email protected]Applied Therapeutics, Inc.
Statement of Operations
(in thousands, except share and per share data)Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 OPERATING EXPENSES: Research and development $ 19,945 $ 7,453 $ 47,974 $ 18,582 General and administrative 10,020 3,294 22,744 9,331 Total operating expenses 29,965 10,747 70,718 27,913 LOSS FROM OPERATIONS (29,965 ) (10,747 ) (70,718 ) (27,913 ) OTHER INCOME (EXPENSE), NET: Interest income (expense), net 131 34 435 33 Other income (expense) (10 ) — 11 — Total other income (expense), net 121 34 446 33 Net loss $ (29,844 ) $ (10,713 ) $ (70,272 ) $ (27,880 ) Net loss attributable to common stockholders—basic and diluted $ (29,844 ) $ (10,713 ) $ (70,272 ) $ (27,880 ) Net loss per share attributable to common stockholders—basic and diluted $ (1.33 ) $ (0.63 ) $ (3.22 ) $ (1.98 ) Weighted-average common stock outstanding—basic and diluted 22,426,203 17,095,870 21,790,207 14,085,579 Applied Therapeutics, Inc.
Balance Sheet
(in thousands, except share and per share data)As of As of September 30, December 31, 2020 2019 (Unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $ 48,679 $ 18,850 Investments 67,826 20,004 Prepaid expenses and other current assets 6,380 7,301 Total current assets 122,885 46,155 Operating lease right-of-use asset 1,754 2,035 Security deposits and leasehold improvements 199 199 TOTAL ASSETS $ 124,838 $ 48,389 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Current portion of operating lease liabilities 380 356 Accounts payable 1,945 8,793 Accrued expenses and other current liabilities 18,177 4,950 Total current liabilities 20,502 14,099 NONCURRENT LIABILITIES: Noncurrent portion of operating lease liabilities 1,396 1,683 Total noncurrent liabilities 1,396 1,683 Total liabilities 21,898 15,782 STOCKHOLDERS' EQUITY: Common stock, $0.0001 par value; 100,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 22,456,686 shares and 18,531,560 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 2 1 Additional paid-in capital 240,074 99,378 Accumulated other comprehensive loss (94 ) (2 ) Accumulated deficit (137,042 ) (66,770 ) Total stockholders' equity 102,940 32,607 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 124,838 $ 48,389 
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NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today presentation of pre-clinical data demonstrating that Aldose Reductase (AR) inhibition, using the novel AR inhibitor AT-001, normalizes cardiac energy metabolism and prevents cardiac structural and functional abnormalities in a mouse model of Diabetic Cardiomyopathy. AT-001-treated mice exhibited decreased cardiac fatty acid oxidation rates and decreased cardiac oxygen consumption resulting in an improved cardiac efficiency. AT-001 is presently being studied in ARISE-HF, a global Phase 3 randomized, placebo-controlled, pivotal study in DbCM patients at high risk of progression to overt heart failure.
"Aldose Reductase activity causes damage to cardiac tissue in two distinct ways – by actively converting glucose into toxic metabolites which damage cardiomyocytes, and by detracting glucose from otherwise energy efficient pathways," said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. "We have previously demonstrated that Aldose Reductase inhibition with AT-001 prevents insult to cardiomyocytes caused by oxidative stress and mitochondrial dysfunction. Data presented here at AHA confirms that not only does AT-001 treatment prevent damage to cardiomyocytes, but it shunts glucose back through energy efficient pathways, shifting the cells towards a non-diabetic state. This results in improved cardiac function, which has meaningful implications for patients with Diabetic Cardiomyopathy."
Presentation Details
P645 (Abstract #15649): Pharmacological Inhibition of Aldose Reductase by AT-001 Prevents Abnormal Cardiac Energy Metabolism and Improves Heart Function in an Animal Model of Diabetic Cardiomyopathy
Time: Friday, November 13, 9:00 a.m. – 10:00 a.m. ESTThe presentation and poster will be available on the Presentations and Publications section of the Applied Therapeutics website following the conference.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company's lead drug candidate, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric metabolic disease. The Company initiated a pivotal Phase 1/2 clinical trial in June 2019, read out positive top-line biomarker data in adult Galactosemia patients in January 2020 and announced full data from the trial in April 2020. A pediatric Galactosemia study commenced in June 2020. The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.About AT-001
AT-001 is an investigational oral, novel, potent Aldose Reductase inhibitor in Phase 3 clinical development for the treatment of Diabetic Cardiomyopathy. AT-001 has been previously studied in a Phase 1/2 study in approximately 120 patients with type 2 diabetes, a subset of which had DbCM.Investors:
Maeve Conneighton
(212) 600-1902 or
[email protected]Media:
Gleb Sagitov
[email protected] -
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NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today that it will present two poster presentations covering AT-007 in Galactosemia at the upcoming American Society of Human Genetics (ASHG) 2020 Annual Meeting. The presentations include animal model efficacy data and adult clinical data on the safety and biomarker efficacy of Applied Therapeutics' investigational candidate for Galactosemia, AT-007, a Central Nervous System (CNS) penetrant Aldose Reductase Inhibitor (ARI).
"We are pleased to present data on our Galactosemia program at the ASHG conference," said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. "Our preclinical data demonstrates that reduction in galactitol, a toxic metabolite of galactose, prevents long-term CNS complications in an animal model of Galactosemia. In parallel, our clinical data from the ACTION-Galactosemia study demonstrates rapid and sustained reduction in galactitol with once-daily AT-007 treatment. Together, this data represents an important advancement in our understanding of the disease and a potential therapeutic intervention to halt disease progression."
Presentation Details
Poster #1881 (Abstract #3646): Positive Biomarker Efficacy Results from the ACTION-Galactosemia Study
Presenter: Riccardo Perfetti, M.D., Ph.D., Chief Medical Officer of Applied Therapeutics
Time: Monday, October 26, 6:00 a.m. – 11:59 p.m. EDTPoster #1958 (Abstract #3647): Post-Natal Galactitol Reduction is Associated with Normalization of CNS Phenotype in Animal Model of Galactosemia
Presenter: Riccardo Perfetti, M.D., Ph.D., Chief Medical Officer of Applied Therapeutics
Time: Monday, October 26, 6:00 a.m. – 11:59 p.m. EDTSlides will be available on the Presentations and Publications section of the Applied Therapeutics website following the conference.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company's lead drug candidate, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric metabolic disease. The Company initiated a pivotal Phase 1/2 clinical trial in June 2019, read out positive top-line biomarker data in adult Galactosemia patients in January 2020 and announced full data from the trial in April 2020. A pediatric Galactosemia study commenced in June 2020. The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.About AT-007
AT-007 is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in clinical development for treatment of Galactosemia. AT-007 has been studied in an animal model of Galactosemia, which demonstrated that AT-007 reduces toxic galactitol levels and prevents disease complications. Applied Therapeutics is conducting a biomarker based development program in patients with Galactosemia, based on the recently released industry guidance on drug development for low prevalence, slowly progressing rare metabolic diseases. The company received Orphan Designation for AT-007 for Galactosemia in May 2019 and Pediatric Rare Disease Voucher (PRV) designation in 2020.
Investors:
Maeve Conneighton
(212) 600-1902 or
[email protected]Media:
Gleb Sagitov
[email protected] -
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NEW YORK, Oct. 05, 2020 (GLOBE NEWSWIRE) -- KBL Merger Corp. IV (NASDAQ: KBLM or the "Company"), a special purpose acquisition company (SPAC) that previously announced the signing of a definitive agreement to acquire 180 Life Sciences Corp. ("180 Life Sciences"), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain, today announced the appointment of Professor Richard Barker, Larry Gold Md., Shoshana Shendelman PhD., and Donald McGovern Jr., to its Board of Directors, upon completion of the business combination.
180 Life Sciences is led by Dr. James Woody who previously served as the founding CEO of OncoMed Pharmaceuticals, as well as President and General Manager of Roche Bioscience. In addition, he served as Chief Scientific Officer and Senior Vice President of R&D for Centocor, where he led the team responsible for developing Remicade, the first of the TNF inhibitor biologics in collaboration with Prof. Sir Marc Feldmann, one of the founders and Co-Chairman of 180 Life Sciences.
Dr. James Woody, 180 Life Sciences CEO stated, "I'm pleased to welcome Richard, Larry, Shoshana and Donald to our Board of Directors. I have known Larry for many years, and I admire his brilliant work in building Somalogic into the premier worldwide protein identification company. Don and I worked on a biotech board together and his vast PWC international experience will be of immense value to 180 Life Sciences.
"Richard joins, recommended by Sir Marc Feldman, with his broad and skillful experience in science, management, and drug development, having served on the Celgene Board. Shoshana joins as the CEO of Applied Therapeutics, an enterprising biotechnology company she founded and has developed into a dynamic organization. Her recent successful experience in the financing arenas will be exceptionally valuable to our team."
Dr. Larry Gold, Ph.D., is an internationally recognized scientist, member of the U.S. National Academy of Sciences and biotech entrepreneur who founded NeXagen, Inc., which later became NeXstar Pharmaceuticals, Inc., and acquired by Gilead Sciences. Dr. Gold also co-founded the biotech company Synergen, Inc., that was later acquired by Amgen. He currently serves as Chairman of SomaLogic, a company that he founded and formerly served as CEO. He has taught at the University of Colorado Boulder since 1970 and served as Chair of the molecular, cellular and developmental biology department from 1988 to 1992.
Shoshana Shendelman, PhD is the Founder, CEO and Chair of the Board of Directors of Applied Therapeutics Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. Prior to founding Applied Therapeutics in 2016, she founded Clearpoint Strategy Group LLC, a boutique life sciences consulting firm, where she served as the Managing Director from July 2012 to December 2016, and served as a Senior Advisor from January 2017 to December 2018. Dr. Shendelman received her Ph.D. in Cellular, Molecular and Biophysical Studies (CMBS) from Columbia University Vagelos College of Physicians and Surgeons. Dr. Shendelman is a member of the Board of Advisors of Columbia University Medical Center and Columbia University Vagelos College of Physicians & Surgeons, where she serves on the Nominations Committee and the Committee on Innovation and Entrepreneurship.
Professor Richard Barker is an internationally respected leader in healthcare and life sciences. He is the Founding Director of New Medicine Partners, a global firm assisting public and private sector organizations to accelerate the worldwide development and adoption of precision medicine. He is chairman of the South London Health Innovation Network. He also chairs Metadvice, an AI-based digital health company enabling personalized medicine in Europe and the US. He is a board member of Image Analysis, a UK company using MRI to quantify the impact of therapy on disease and (until its recent acquisition by BMS) also of Celgene, a major US-based bio-therapeutics company.
Donald A. McGovern, Jr is the former Vice Chairman, Global Assurance, of PricewaterhouseCoopers LLP (PwC). Through decades of leadership at PwC and board experience, Don brings wide-ranging operational, financial, accounting and audit and public company experience. He currently serves on the board of Cars.com. Don joined the board of Cars.com in May 2017 upon the spinout of Cars.com from Tegna creating a new public company listed on the NYSE. Don is chair of the Audit Committee and a member of the Compensation Committee at Cars.com, and a designated financial expert under SEC regulations. His past public board experience has been with CRH, plc. Don served two three-year terms (2013-2019) on the Board of CRH. During his tenure, he was Senior Independent Director, chair of the Remuneration Committee, a member of the Nomination Committee and of the Audit Committee and a designated financial expert under US SEC and UK FRC regulations.
About 180 Life Sciences Corp.
180 Life Sciences Corp. is a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain by leveraging the combined expertise of luminaries in therapeutics from Oxford University, the Hebrew University and Stanford University. 180 Life Sciences is leading the research into solving one of the world's biggest drivers of disease – inflammation. The company is driving groundbreaking study into clinical programs, which are seeking to develop novel drugs addressing separate areas of inflammation for which there are no effective therapies. The company's primary platform is a novel program to treat fibrosis and inflammation using anti-TNF, with its lead program in phase 2b/3 clinical trials
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of U.S. federal securities laws. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue" and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements and factors that may cause such differences include, without limitation, statements relating to the timing and completion of the proposed business combination; KBLM's continued listing on the Nasdaq Stock Market until closing of the proposed business combination; expectations regarding the capitalization, resources and ownership structure of the combined company; the inability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, the amount of cash available following any redemptions by KBLM stockholders; the ability to meet the Nasdaq Stock Market's listing standards following the consummation of the transactions contemplated by the proposed business combination; costs related to the proposed business combination; expectations with respect to future performance, growth and anticipated acquisitions; ability to recognize the anticipated benefits of the proposed business combination; 180 Life Sciences' ability to execute its plans to develop and market new drug products and the timing and costs of these development programs; 180 Life Sciences' estimates of the size of the markets for its potential drug products; potential litigation involving KBLM or 180 Life Sciences or the validity or enforceability of the intellectual property of 180 Life Sciences; global economic conditions; geopolitical events and regulatory changes; access to additional financing; and other risks and uncertainties indicated from time to time in filings with the SEC. Other factors include the possibility that the proposed business combination does not close, including due to the failure to receive required security holder approvals, or the failure of other closing conditions. The foregoing list of factors is not exclusive. Additional information concerning these and other risk factors is contained in KBLM's most recent filings with the SEC, as well as in the definitive proxy statement/prospectus filed as result of the transactions described above. All subsequent written and oral forward-looking statements concerning KBLM or 180 Life Sciences, the transactions described herein or other matters and attributable to KBLM or 180 Life Sciences or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. None of KBLM or 180 Life Sciences undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based.Additional Information and Where to Find It
KBLM has filed a registration statement on Form S-4, which includes a preliminary proxy statement/prospectus for KBLM's stockholders, with the Securities and Exchange Commission. The definitive proxy statement/prospectus will be mailed to KBLM's stockholders that do not opt to receive the document electronically. KBLM and 180 Life Sciences urge investors, stockholders and other interested persons to read the preliminary proxy statement/prospectus, as well as other documents that will be filed with the SEC, because these documents will contain important information about the proposed business combination. Such persons can also read KBLM's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, for a description of the security holdings of its officers and directors and their respective interests as security holders in the consummation of the proposed business combination. KBLM's definitive proxy statement/prospectus, which is included in the registration statement, will be mailed to stockholders of KBLM as of a record date to be established. KBLM's stockholders will also be able to obtain a copy of such documents, without charge, by directing a request to: KBL Merger Corp. IV, 30 Park Place, Suite 45E, New York, NY 10007; e-mail: [email protected]. These documents can also be obtained, without charge, at the SEC's web site (http://www.sec.gov).
Participants in Solicitation
KBLM and its directors and executive officers may be deemed to be participants in the solicitation of proxies for the special meeting of KBLM's stockholders to be held to approve the proposed transactions in connection with the business combination with 180 Life Sciences. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of KBLM's stockholders in connection with the proposed business combination with 180 Life Sciences are set forth in the preliminary proxy statement/prospectus included in the registration statement that was filed with the SEC on August 28, 2020. You can find information about KBLM's executive officers and directors in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on April 7, 2020. You can obtain free copies of these documents from KBLM using the contact information above.
Non-Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination between KBLM and 180 Life Sciences and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of KBLM and 180 Life Sciences, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Contacts:
Media Inquiries:
Elyse Segall
Pr Revolution
516-901-9095
[email protected]Investors:
Jason Assad
Director of IR
180 Life Sciences Corp
678-570-6791
[email protected] -
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NEW YORK, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has granted AT-007 both Pediatric Rare Disease Designation and Orphan Drug Designation for treatment of PMM2-CDG. PMM2-CDG is a debilitating rare disease caused by deficiency in the critical enzyme phosphomannomutase-2, required for systemic glycosylation of proteins. PMM2-CDG causes multiple organ failure and severe disability, resulting in approximately 20% mortality in the first four years of life. There are currently no drugs approved to treat PMM2-CDG.
AT-007, a novel CNS penetrant Aldose Reductase inhibitor (recently given the INN scientific name gavorestat) has demonstrated biological activity in a validated model of PMM2-CDG. Applied Therapeutics plans to initiate a clinical study in 2021 and is currently working with CDG experts and the FDA to design a robust clinical program.
"PMM2-CDG is a debilitating disease with no drugs available, which is central to Applied Therapeutics' mission of creating life-changing treatments for patients who desperately need them," said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. "Over the past year we have been working closely with clinicians, researchers and families of PMM2-CDG patients, and are grateful for their collaboration and support. We are pleased that the FDA recognizes the transformative potential of AT-007 in treating patients with PMM2-CDG."
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company's lead drug candidate, AT-007, is a novel central nervous system penetrant aldose reductase inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Galactosemia and PMM2-CDG. The Company initiated a Galactosemia clinical program in June 2019, read out positive data in adult Galactosemia patients in April 2020, and commenced a pediatric Galactosemia study in June 2020. Applied plans to initiate a clinical study of AT-007 in PMM2-CDG in 2021.The Company is also developing AT-001, a novel potent ARI that is being developed for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The Company initiated a Phase 3 registrational study in DbCM in September 2019. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of diabetic retinopathy, as well as novel dual PI3k inhibitors in preclinical development for orphan oncology indications.
Investors:
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