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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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
AT-007 (ACTION-Galactosemia kids)
Galactosemia
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Phase 1/2
Phase 1/2
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Phase 1/2 trial clinical hold has been lifted - February 1, 2021.
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|
ALPN-101
Healthy Volunteers
|
Phase 1
Phase 1
|
Phase 1 data presented at EULAR June 8, 2020 - well tolerated and exhibited pharmacodynamic activity, enabling Phase 2 development.
|
Latest News
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NEW YORK, Feb. 23, 2021 (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 at two upcoming investor conferences in March:
Cowen 41st Annual Health Care Conference
Date: Tuesday, March 2, 2021
Time: 9:10 – 9:40 a.m. ETBarclays Global Healthcare Conference
Date: Tuesday, March 9, 2021
Time: 4:45 – 5:10 p.m. ETWebcast information for these events will be accessible on the Events page under the Investor Relations section of the Applied Therapeutics website at www.appliedtherapeutics.com. A replay will also be available following the webcast.
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. 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:
Maeve Conneighton
(212) 600-1902 or
[email protected]Media:
Gleb Sagitov
[email protected]
-
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NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the closing of its public offering of 3,000,000 shares of its common stock, par value $0.0001 per share. The shares were offered at a price to the public of $23.00 per share, resulting in aggregate net proceeds of approximately $64.6 million, after deducting underwriting discounts and commissions and estimated offering expenses. The offering closed on February 17, 2021. The Company granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock at the price to the public, less underwriting discounts and commissions, which the underwriters exercised in full on February 17, 2021 and settled on February 19, 2021.
The Company intends to use the net proceeds from this offering, together with its existing cash, to advance clinical and preclinical development of its product candidates, prepare for commercialization and other general corporate purposes.
Goldman Sachs & Co. LLC, Cowen and UBS Investment Bank acted as joint book-running managers for the offering. Baird acted as lead manager for the offering.
The offering was made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the final prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at (833) 297-2926; or UBS Securities LLC, Attn: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at [email protected]
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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, including, but not limited to, statements regarding the Company's anticipated use of the net proceeds from the offering and other statements regarding the offering. All statements contained in this press release other than historical information are forward-looking statements that involve known and unknown risks and relate to future events, our future financial performance or our projected business results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "targets," "potential" or "continue" or the negative of these terms or other comparable terminology. Such forward-looking statements are necessarily estimates based upon current information and involve a number of risks and uncertainties. Actual events or results may differ materially from the results anticipated in these forward-looking statements as a result of a variety of factors.All forward-looking statements speak only as of the date on which it is made. When considering forward-looking statements, you should keep in mind the risk factors and other cautionary statements included in our annual, quarterly and other reports we file with the SEC. We undertake no duty to update these forward-looking statements, even though our situation may change in the future. Furthermore, we cannot guarantee future results, events, levels of activity, performance, projections or achievements.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902
[email protected]Media:
Gleb Sagitov
[email protected] -
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NEW YORK, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the pricing of its underwritten public offering of 3,000,000 shares of its common stock, par value $0.0001 per share, at a price to the public of $23.00 per share. The gross proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, are expected to be $69 million. The Company has granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock at the price to the public, less underwriting discounts and commissions.
The Company intends to use the net proceeds from this offering, together with its existing cash, to advance clinical and preclinical development of its product candidates, prepare for commercialization and other general corporate purposes.
Goldman Sachs & Co. LLC, Cowen and UBS Investment Bank are acting as joint book-running managers for the offering. Baird is acting as lead manager for the offering. The offering is expected to close on February 17, 2021, subject to customary closing conditions.
The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the final prospectus supplement and the accompanying prospectus relating to the proposed offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at (833) 297-2926; or UBS Securities LLC, Attn: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at [email protected]. Before you invest, you should read the prospectus in that registration statement and other documents the Company has filed with the SEC for more complete information about the Company and the proposed offering.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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, including, but not limited to, statements regarding the Company's anticipated use of the net proceeds from the offering and other statements regarding the offering. All statements contained in this press release other than historical information are forward-looking statements that involve known and unknown risks and relate to future events, our future financial performance or our projected business results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "targets," "potential" or "continue" or the negative of these terms or other comparable terminology. Such forward-looking statements are necessarily estimates based upon current information and involve a number of risks and uncertainties. Actual events or results may differ materially from the results anticipated in these forward-looking statements as a result of a variety of factors.All forward-looking statements speak only as of the date on which it is made. When considering forward-looking statements, you should keep in mind the risk factors and other cautionary statements included in our annual, quarterly and other reports we file with the SEC. We undertake no duty to update these forward-looking statements, even though our situation may change in the future. Furthermore, we cannot guarantee future results, events, levels of activity, performance, projections or achievements.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902 or
[email protected]Media:
Gleb Sagitov
[email protected] -
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NEW YORK, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that it plans to make a public offering of 3,000,000 shares of its common stock, par value $0.0001 per share, in an underwritten registered public offering. The Company expects to grant the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock.
The Company intends to use the net proceeds from this offering, together with its existing cash, to advance clinical and preclinical development of its product candidates, prepare for commercialization and other general corporate purposes.
Goldman Sachs & Co. LLC, Cowen and UBS Investment Bank are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the final size or terms of the offering.
The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at (833) 297-2926; or UBS Securities LLC, Attn: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at [email protected]. Before you invest, you should read the prospectus in that registration statement and other documents the Company has filed with the SEC for more complete information about the Company and the proposed offering.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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, including but not limited to statements regarding the Company's anticipated use of the net proceeds from the offering and other statements regarding the offering. All statements contained in this press release other than historical information are forward-looking statements that involve known and unknown risks and relate to future events, our future financial performance or our projected business results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "targets," "potential" or "continue" or the negative of these terms or other comparable terminology. Such forward-looking statements are necessarily estimates based upon current information and involve a number of risks and uncertainties. Actual events or results may differ materially from the results anticipated in these forward-looking statements as a result of a variety of factors.All forward-looking statements speak only as of the date on which it is made. When considering forward-looking statements, you should keep in mind the risk factors and other cautionary statements included in our annual, quarterly and other reports we file with the SEC. We undertake no duty to update these forward-looking statements, even though our situation may change in the future. Furthermore, we cannot guarantee future results, events, levels of activity, performance, projections or achievements.
Contacts
Investors:
Maeve Conneighton
(212) 600-1902 or
[email protected]Media:
Gleb Sagitov
[email protected] -
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FDA Clinical Hold Lifted
NEW YORK, Feb. 01, 2021 (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 announced that the FDA has lifted the hold and the AT-007 ACTION-Galactosemia Kids pediatric clinical study will resume effective immediately. Applied Therapeutics has worked closely with FDA to modify the trial, with the shared goal of ensuring that all patients have the opportunity to receive clinical benefit.
Previously, the ACTION-Galactosemia Kids program was split into two separate clinical studies – a dose escalation and biomarker study followed by a separate long-term clinical outcomes study. The two studies have now been combined into a single two-part study to ensure that all patients who complete the dose escalation and biomarker portion of the study will seamlessly continue into the long-term outcomes study without treatment interruption. Additionally, the dose-escalation portion of the study has been operationally modified to ensure continuous drug treatment and participation throughout the study. All patients who were already randomized and participating in the ACTION-Galactosemia Kids study will be eligible to return to the study, and the Company anticipates being fully enrolled within a matter of weeks. The Company remains on target to submit an NDA no later than Q3 2021.
"We thank the Galactosemia community for their patience and support, and we are grateful to the FDA for their partnership," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We believe that the program is in a stronger position for overall success and potential approval due to our close collaboration with FDA. AT-007 represents an important advancement for Galactosemia patients, and offering a therapeutic option to children is a priority for Applied Therapeutics."
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. AT-007 was also studied in an adult biomarker-based clinical study and demonstrated significant reduction in plasma galactitol levels vs. placebo; the long-term extension in adults remains ongoing. The company received Orphan Designation for AT-007 for Galactosemia in May 2019 and Pediatric Rare Disease Voucher (PRV) designation in 2020.
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.
Investors:
Maeve Conneighton
(212) 600-1902 or
[email protected]Media:
Gleb Sagitov
[email protected]