PTGX Protagonist Therapeutics Inc.

33.26
-1.45  -4%
Previous Close 34.71
Open 33.29
52 Week Low 12.8
52 Week High 50.54
Market Cap $1,587,440,830
Shares 47,728,227
Float 38,115,527
Enterprise Value $1,348,610,759
Volume 271,454
Av. Daily Volume 2,430,683
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Upcoming Catalysts

Drug Stage Catalyst Date
Rusfertide (PTG-300)
Polycythemia vera
Phase 2
Phase 2
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PN-235
Healthy volunteers
Phase 1
Phase 1
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PN-943
Ulcerative colitis
Phase 2
Phase 2
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PN-232
Healthy volunteers
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Rusfertide (PTG-300)
Hereditary hemochromatosis
Phase 2
Phase 2
Phase 2 data released November 15, 2021. Phase 2 trial met primary endpoint, rusfertide-treated patients had 0.009 phlebotomies per month during the study compared to 0.28 phlebotomies per month pre-study. The average TSAT during treatment was 31.4% compared to 45.0% pre-study and the serum iron was 101 mcg/dl compared to 137 mcg/dl.
Rusfertide (PTG-300)
Beta-thalassemia
Phase 2
Phase 2
Phase 2 clinical hold lifted October 11, 2021.
PTG-200
Crohn's disease
Phase 2
Phase 2
Phase 2 trial and candidate development has been stopped, noted November 3, 2021.
PTG-100
Ulcerative colitis
Phase 2b
Phase 2b
Phase 2b trial discontinued following interim analysis - March 26, 2018. However, company noted August 6, 2018 that human error by CRO contributed to this decision.

Latest News

  1. NEWARK, Calif., Nov. 15, 2021 /PRNewswire/ -- Protagonist Therapeutics (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced results from a Phase 2a study in which rusfertide, an investigational new drug, is being evaluated for the treatment of hereditary hemochromatosis (HH). HH is a genetic disorder arising from a deficiency or dysregulation of the natural hormone hepcidin, a condition which causes the body to absorb too much iron. The clinical data from the study were presented in an oral presentation at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD).

    "Despite its prevalence, no drug therapies have been developed to date for the treatment of hereditary hemochromatosis," said Kris V. Kowdley, M.D., Director of Liver Institute Northwest, Professor at the Elson S. Floyd College of Medicine at Washington State University, an author of the ACG Guidelines for HH, and the study's principal investigator. "I'm encouraged by the efforts Protagonist has undertaken in this area of iron overload diseases, and specifically by the Phase 2 data that demonstrates rusfertide's therapeutic effect by several different measures, including pharmacodynamic effects, reduction in phlebotomy requirements, stabilization of liver iron content, and possible improvements in quality-of-life measures. Hereditary hemochromatosis is characterized by low levels of hepcidin, with variability of severity in clinical manifestations across different patient sub-populations. Rusfertide has the potential to offer a treatment option for patients in whom phlebotomy may be difficult or contraindicated."

    "Rusfertide has the potential to be the first-in-class drug therapy for an HH indication," said Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. "After polycythemia vera, this marks a second indication where rusfertide has demonstrated a positive clinical proof-of-concept, thereby signaling a broader potential utility to address unmet needs of patients in these diseases. The study results announced at AASLD will serve as an important foundation for the next steps that we will determine in consultation with key clinical investigators and regulatory agencies. Going forward, our focus will be on proving rusfertide's potential to address unmet medical needs in specific subpopulations of HH."

    Study Design and Summary of Results:

    • The study was an open-label multicenter Phase 2 study in 16 patients that was designed to evaluate the safety and efficacy of rusfertide as a treatment for patients with HH. The requirement for, and frequency of, therapeutic phlebotomies, a key endpoint of the study, was statistically significant: rusfertide-treated patients had 0.009 phlebotomies per month during the study compared to 0.28 phlebotomies per month pre-study (p<0.0001).
    • The average TSAT during treatment with rusfertide was 31.4% compared to 45.0% pre-study (p=0.0051) and the serum iron during treatment with rusfertide was 101 mcg/dl compared to 137 mcg/dl pre-study (p=0.0106). Eighty percent of patients who came into the study with baseline TSAT values above 45% (N=10) achieved average TSAT values that were normalized (<45%) during rusfertide treatment. All the subjects with elevated serum iron above 170 mcg/dl at baseline (N=5) were able to maintain an average serum iron within a normal range of <170 mcg/dl during rusfertide treatment. While ferritin levels varied during treatment with rusfertide, average ferritin levels were below 200 ng/mL in 15 of the 16 patients.
    • Patients underwent MRI to measure Liver Iron Content (LIC) at the beginning and end of the study. Rusfertide treatment maintained or reduced average LIC, despite fewer phlebotomies over the duration of the study.
    • Patients reported trends of qualitative improvements in Quality of Life measures through the duration of the study.
    • Rusfertide was well tolerated in this study population. Adverse events (AEs) were generally of Grade 1 or 2 except for one report of an adenocarcinoma of the pancreas that was pre-existing and therefore considered not related to drug. Treatment-emergent injection site reactions, all of which were mild or moderate and transient in nature, occurred in 50% of patients. Other treatment-emergent AEs reported in two or more patients included headache, diarrhea, dizziness, hypertension, and fatigue all of which were mild or moderate.

    About Hereditary Hemochromatosis

    Hereditary hemochromatosis (HH) is a genetic disorder characterized by excessive iron absorption due to a deficiency or dysregulation in hepcidin. The disorder results in the accumulation of excess iron in the body's organs. Approximately one million people in the United States have HFE mutations consistent with type 1 HH; out of these, 10 to 15 percent develop clinical manifestations of the disease. The clinical symptoms of hemochromatosis usually appear after significant iron accumulation—generally after the age of 40. Early signs are nonspecific and can include weakness, lethargy, increased skin pigmentation, hair loss, impotence, joint pains, vertigo, and loss of memory.

    In HH types 1-3, mutations in genes encoding hepcidin regulators or hepcidin itself lead to diminished production of hepcidin, thus decreasing the inhibitory effect of hepcidin on duodenal iron absorption and causing clinical iron overload (Brissot 2011). Hepcidin deficiency leads to increased circulating transferrin saturation, and ultimately, iron accumulation in organs such as the liver, pancreas, heart, and bone. Iron in excess may induce or favor the development of complications such as cirrhosis, liver cancer, diabetes, heart failure, hypogonadism, but also, complaints such as asthenia and disabling arthritis.

    The goal of treatment in HH patients is to reduce the development of such complications. Per ACG Guidelines, patients with elevated serum ferritin above 200 ng/mL in females and 300 ng/mL in males along with a transferrin saturation (TSAT) at or above 45 percent will require treatment to reduce serum ferritin to the range of 50-100 ng/mL and subsequently decrease TSAT levels to below 45 percent.

    There is no approved medicine for treatment of HH, and phlebotomy continues to be the main treatment option. Patients living with clinical manifestations of HH require continued phlebotomies for their entire lives to limit end-organ damage. While therapeutic phlebotomy is effective in removing excess iron and preventing most of the complications associated with excess iron in the body, this treatment does not target the biological mechanisms leading to iron metabolism disturbance. Approximately 25% of patients in maintenance felt that receiving phlebotomies was "inconvenient" or "very inconvenient" (Brissot 2011), and patient compliance with phlebotomies generally declines over time (Hicken et al, 2003).

    In hepcidin-deficient mouse models of hemochromatosis, a mini-hepcidin and rusfertide were found to be effective in decreasing iron loading in the liver compared to vehicle treated control mice that were iron overloaded (Ramos 2012, Taranath 2019). These pre-clinical observations along with our clinical findings in the current study suggest that a hepcidin mimetic such as rusfertide may be effective for preventing iron overload in patients with hemochromatosis.

    About Protagonist

    Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform.

    Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2a study for hereditary hemochromatosis. The Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

    The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.

    The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds in development include PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates. The Phase 1 study of PN-235 is completed, and Janssen is expected to initiate a Phase 2 study in psoriasis in early 2022. The Phase 1 study with PN-232 is in progress, with study completion expected by mid-2022. Additional clinical development in IBD is expected to initiate in 2022. 

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the Company's clinical development program for rusfertide in HH, and the potential benefits of rusfertide in HH patients. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release.  Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-phase-2a-data-supporting-the-potential-use-of-rusfertide-as-a-first-in-class-therapy-in-hereditary-hemochromatosis-301423690.html

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  2. NEWARK, Calif., Nov. 11, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will present and host one-on-one meetings with investors at upcoming healthcare investor conferences hosted by Jefferies and Piper Sandler.

    Presentation Details:

    Event: Jefferies London Healthcare Conference

    Date: November 18, 2021

    Time: 3 a.m. EST



    Event: Piper Sandler 33rd Annual Healthcare Conference

    Date: November 22, 2021

    Time: 10 a.m. EST

    A webcast of the event will be available for 90 days on the Investors section of the Protagonist Therapeutics website at http://investors.protagonist-inc.com/.

    About Protagonist

    Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform.

    Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis. The Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

    The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.

    The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds in development include PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates. The Phase 1 study of PN-235 is completed, and Janssen is expected to initiate a Phase 2 study in psoriasis in early 2022. The Phase 1 study with PN-232 is in progress, with study completion expected by mid-2022. Additional research in IBD is expected to initiate in 2022. 

    Protagonist is headquartered in Newark, California. For further information, please visit www.protagonist-inc.com.

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  3. NEWARK, Calif., Nov. 4, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that two abstracts highlighting updated data from its Phase 2 study of rusfertide in polycythemia vera (PV) have been selected for oral presentations at the American Society of Hematology (ASH) 2021 Annual Meeting taking place December 11-14, 2021. An additional three abstracts on rusfertide in PV and hereditary hemochromatosis (HH) have been accepted as poster presentations at ASH.

    "We are delighted to have the opportunity to present further evidence of rusfertide's potential to improve outcomes in polycythemia vera and other diseases related to iron dysregulation," said Dinesh V. Patel, PhD, President and…

    NEWARK, Calif., Nov. 4, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that two abstracts highlighting updated data from its Phase 2 study of rusfertide in polycythemia vera (PV) have been selected for oral presentations at the American Society of Hematology (ASH) 2021 Annual Meeting taking place December 11-14, 2021. An additional three abstracts on rusfertide in PV and hereditary hemochromatosis (HH) have been accepted as poster presentations at ASH.

    "We are delighted to have the opportunity to present further evidence of rusfertide's potential to improve outcomes in polycythemia vera and other diseases related to iron dysregulation," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist. "Data included in these oral presentations will provide important new information about how rusfertide may reduce the need for phlebotomy and control hematocrit levels and symptoms for patients suffering from PV. The data we share at ASH this year will serve as a valuable springboard for further advancement of our rusfertide clinical programs, including the initiation of a Phase 3 clinical trial of rusfertide in PV in the first quarter of 2022."

    Details for ASH 2021 oral presentations are as follows:

    Title: "Rusfertide (PTG-300) Controls Hematocrit Levels and Essentially Eliminates Phlebotomy Requirement in Polycythemia Vera Patients"

    Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK inhibitors for Myelofibrosis

    Presentation Type: Oral

    Presentation Date and Time: Sunday, December 12, 2021/Session Time: 9:30 AM - 11:00 AM/Presentation Time: 10:15 AM

    Authors: Ronald Hoffman, MD, Marina Kremyanskaya, MD, PhD, Yelena Ginzburg, MD, Andrew Kuykendall, MD, Naveen Pemmaraju, MD, Abdulraheem Yacoub, MD, Jay Yang, MD, Suneel Gupta, PhD, Frank Valone, MD, Sarita Khanna, PhD and Srdan Verstovsek, MD, PhD

    Title: "Rusfertide (PTG-300) Induction Therapy Rapidly Achieves Hematocrit Control in Polycythemia Vera Patients without the Need for Therapeutic Phlebotomy"

    Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK inhibitors for Myelofibrosis

    Presentation Type: Oral

    Presentation Date and Time: Session Date: Sunday, December 12, 2021/Session Time: 9:30 AM - 11:00 AM/Presentation Time: 10:45 AM

    Authors: Yelena Ginzburg, MD, Kamini Kirubamoorthy, Sinari Salleh, MD, Sung-Eun Lee, MD, PhD, Jae Hoon Lee, MD, PhD, Veena Selvaratnam, MD, Suneel K Gupta, PhD, Frank Valone, MD, Sarita Khanna, PhD, Nishit Modi, PhD, Ronald Hoffman, MD and Lee Ping Chew, MD

    Additional details for ASH 2021 poster presentations are as follows:

    Title: "A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera"

    Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I

    Presentation Type: Poster

    Presentation Date and Time: Saturday, December 11, 2021/Presentation Time: 5:30 PM - 7:30 PM

    Authors: Srdan Verstovsek, MD, PhD, Andrew Kuykendall, MD, Ronald Hoffman, MD, Yelena Ginzburg, MD, Naveen Pemmaraju, MD, Frank Valone, MD, Nishit Modi, PhD, Sarita Khanna, PhD, Paula G O'Connor, MD, Suneel K Gupta, PhD and Jean-Jacques Kiladjian, MD, PhD

    Title: "Regulation of Iron Homeostasis and Efficacy of Rusfertide Analog Peptide in a Mouse Model for Polycythemia Vera"

    Session Title: 102. Iron Homeostasis and Biology: Poster II

    Presentation Type: Poster

    Presentation Date and Time: Sunday, December 12, 2021/Presentation Time: 6:00 PM - 8:00 PM

    Authors: Roopa Taranath, PhD, Li Zhao, MD, PhD, Jayanthi Vengalam, MS, Lawrence Lee, BS,

    Tenny Tang, MS, Celino Dion, Ahu Su, BS, James Tovera, BS, Ashok Bhandari, PhD,

    Xiaoli Cheng, PhD, Larry Mattheakis, PhD and David Y Liu, PhD

    Title: "Rusfertide (PTG-300), a Hepcidin Mimetic, Maintains Liver Iron Concentration in the Absence of Phlebotomies in Patients with Hereditary Hemochromatosis"

    Session Title: 102. Iron Homeostasis and Biology: Poster I

    Presentation Type: Poster

    Presentation Date and Time: Date: Saturday, December 11, 2021/Presentation Time: 5:30 PM -7:30 PM

    Authors: Kris V. Kowdley, MD, Nishit B Modi, PhD, Frank Valone, MD, Victor Priego, MD, Christopher Ferris, MD, PhD, Frank Cole, MD, and Suneel Gupta, PhD

    Full abstracts can be found on the ASH website at https://www.hematology.org/meetings/annual-meeting/abstracts

    About Protagonist Therapeutics

    Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform. Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic which is currently in Phase 2 development for the treatment of polycythemia vera and hereditary hemochromatosis. As announced on September 17, 2021, all rusfertide studies are currently placed on clinical hold per a decision of the U.S. Food and Drug Administration. The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.  In addition, Protagonist has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered interleukin-23 receptor specific antagonist peptide which is currently in Phase 2 development for Crohn's disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are currently in Phase 1 studies.  For further information, please visit www.protagonist-inc.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the Company's clinical development program for rusfertide. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release.  Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

    Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

     

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  4. NEWARK, Calif., Nov. 3, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today reported its financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "We are excited to share the substantial progress made thus far in all of our clinical programs, highlighted by the presentation of proof-of-concept data on rusfertide in hereditary hemochromatosis at the upcoming AASLD meeting, and the new rusfertide data in polycythemia vera, which will be presented by the year's end," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. "We were very pleased that the FDA reached a swift resolution regarding the clinical hold placed on rusfertide, and we are…

    NEWARK, Calif., Nov. 3, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today reported its financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "We are excited to share the substantial progress made thus far in all of our clinical programs, highlighted by the presentation of proof-of-concept data on rusfertide in hereditary hemochromatosis at the upcoming AASLD meeting, and the new rusfertide data in polycythemia vera, which will be presented by the year's end," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. "We were very pleased that the FDA reached a swift resolution regarding the clinical hold placed on rusfertide, and we are in the process of resuming all rusfertide clinical studies. Additionally, we are highly encouraged with the rate of enrollment in the Phase 2 study of our oral alpha-4-beta-7 integrin antagonist PN-943, for ulcerative colitis, an indication with a large patient population and unmet treatment need. We maintain our guidance of a data readout in Q2 2022, and in anticipation of this, we are excited that Dr. Scott Plevy has joined our team as Executive Vice President and Therapeutic Head, Gastroenterology. As a renowned gastroenterologist, Dr. Plevy will oversee the clinical development of PN-943 and other future programs focused on gastrointestinal diseases. Finally, our oral IL-23 receptor antagonist program, in partnership with Janssen, continues to make demonstrated progress, with PN-235 now advancing into a Phase 2 study in psoriasis in early 2022."

    Third Quarter 2021 Recent Developments and Upcoming Milestones

    Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

    • On October 11, 2021, Protagonist announced that the U.S. Food and Drug Administration (FDA) removed the full clinical hold on rusfertide's clinical studies after the Company provided the FDA with all requested information, including the individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, conducted a comprehensive review of the most recent safety database, and added new safety and stopping rules in the study protocols. This was in response to the Company receiving a communication from the FDA that Protagonist's clinical studies for rusfertide had been placed on clinical hold on September 17, 2021. Protagonist has been working closely with study investigators and clinical trial sites to resume enrollment and dosing of patients in ongoing clinical trials with rusfertide.
    • An abstract highlighting new, preliminary data from a Phase 2 proof-of-concept study in hereditary hemochromatosis (HH) has been selected for oral presentation by Dr. Kris Kowdley, from the Liver Institute Northwest in Seattle. These data will be presented on November 13, 2021 at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD).
    • The Company intends to report updated data from the Phase 2 study of rusfertide in polycythemia vera (PV) by the end of 2021.
    • The Company is on track to initiate the Phase 3 study of rusfertide in PV in Q1 2022.
    • The Company resolved its collaboration agreement dispute with Zealand Pharma, reducing future development and sales milestone payments and royalties owed to Zealand for rusfertide under the companies' 2012 collaboration agreement. Under the new terms of the agreement, future development and sales milestone payments (other than $2.5 million in near-term milestones) and royalties for rusfertide have been reduced by 50 percent. Milestones and royalty payments will be due for sales and milestones achieved by either Protagonist or any future rusfertide licensee or partner. Protagonist will also make a $1.5 million payment to Zealand in August 2022.

    PN-943: Oral, gut-restricted, alpha-4-Beta-7 Integrin Antagonist for Ulcerative Colitis

    • We are continuing to see steady progress in the enrollment and execution of the Phase 2 IDEAL study of PN-943 in ulcerative colitis. This study includes a 12-week induction period and a 40-week open label extension. Topline data from the 12-week induction period is expected in the second quarter of 2022.
    • Scott Plevy, M.D., renowned expert in translational and clinical research in gastroenterology and immunology, was appointed Executive Vice President and Therapeutic Head, Gastroenterology, and he will oversee clinical operations and development of Protagonist's ongoing and future programs in gastrointestinal diseases, including PN-943.

    Oral IL-23 Receptor Antagonists (collaboration between Janssen Biotech, Inc. and Protagonist)

    • Following a pre-specified interim analysis criteria, a portfolio decision was made to stop further development of the first-generation IL-23 receptor antagonist (IL-23R) candidate PTG-200 (JNJ-67864238), in favor of continued development of the two second generation candidates PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186) with superior product profiles. In particular:
      • The Phase 1 study of PN-235 is completed, and a Phase 2 study in psoriasis is anticipated to initiate in early 2022.
      • The Phase 1 study with PN-232 is under progress with study completion expected by mid-2022.
      • Additional development in IBD is expected to initiate in 2022.
    • Protagonist will earn a $25 million milestone in connection with the initiation of the first Phase 2 study of a second-generation candidate, and a $10 million milestone in connection with the initiation of the second Phase 2 study of a second-generation candidate. Protagonist remains eligible for up to approximately $900 million in development-related milestone payments, in addition to the $87.5M in milestones already earned.
    • Protagonist received a $7.5 million milestone payment from Janssen, triggered by the completion of the clinical data collection Phase 1 activities for PN-235 (JNJ-2113).

    Third Quarter 2021 Financial Results

    • Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2021, were $352.5 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through 2024.
    • License and Collaboration Revenue: License and collaboration revenues were $10.3 million and $18.7 million for the three and nine months ended September 30, 2021, respectively, as compared to $13.1 million and $23.0 million reported for the same periods of 2020. The Company recognized $8.0 million as a cumulative catch-up amount during the three months ended September 30, 2021, following the amendment of its collaboration agreement for the development of IL-23 receptor antagonist assets with Janssen Biotech. This cumulative catch-up was primarily the result of an acceleration of our cumulative performance completed under our obligation, following the amendment to the collaboration which reduced the remaining services the Company is responsible to conduct. We are nearing completion of our remaining services to be provided to Janssen under the collaboration, in particular, both the ongoing Phase 1 trials in PN-235 and PN-232, are expected to be complete in the fourth quarter of 2021 and second quarter 2022, respectively. Revenue for the prior year's third quarter of 2020 also included an estimate update for services completed versus remaining services to be performed under the Janssen collaboration agreement which accelerated revenue recognition.
    • Research and Development ("R&D") Expenses: R&D expenses for the three and nine months ended September 30, 2021, were $37.0 million and $87.6 million, respectively, as compared to $16.0 million and $55.0 million, respectively, for the same periods of 2020. The increases were primarily due to additional costs associated to advancing our clinical trials with our pipeline assets rusfertide and PN-943, as well as our second-generation IL-23 receptor antagonist assets under the Janssen collaboration (PN-235 and PN-232). The increases also relate to higher research spending and employee related costs, including stock-based compensation expenses following recent hiring in support of our advancing research and development programs. Following the amendment to the Zealand collaboration agreement we also recorded $4.0 million in the quarter ended September 30, 2021 in R&D expense related to these collaboration payments.
    • General and Administrative ("G&A") Expenses: G&A expenses for the three and nine months ended September 30, 2021, were $7.3 million and $19.9 million, respectively, as compared to $4.9 million and $13.6 million for the same periods of 2020. The increases were primarily related to professional fees, insurance costs and employee compensation related expenses, including stock-based compensation expenses, supporting the growth in our operations.
    • Stock Based Compensation ("SBC") Expenses: SBC expenses for the three and nine months ended September 30, 2021, were $4.8 million and $11.4 million, respectively, as compared to $1.8 million and $5.9 million, respectively, for the same periods of 2020. SBC increases included in R&D and G&A expenses are primarily attributable to the addition of new employees and related stock grants in support of the Company's continued growth coupled with the increase in the Company's stock price at grant date which is used in the SBC expense calculation.
    • Net Loss: The third quarter 2021 net loss was $33.8 million, or a net loss of $0.70 per share, and the nine months ended September 30, 2021, net loss was $88.6 million, or a net loss of $1.94 per share, compared to the third quarter of 2020 net loss of $7.8 million, or a net loss of $0.21 per share, and the nine months ended September 30, 2020, net loss of $47.3 million, or a net loss of $1.45 per share.

    About Protagonist

    Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform.

    Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis. The Company plans to initiate a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

    The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.

    The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds in development include PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates. The Phase 1 study of PN-235 is completed, and Janssen is expected to initiate a Phase 2 study in psoriasis in Q1 2022. The phase 1 study with PN-232, the second 2nd generation candidate, is under progress with study completion expected by mid-2022. Additional research in IBD is expected to initiate in 2022.

    Protagonist is headquartered in Newark, California. For further information, please visit www.protagonist-inc.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the Company's clinical development program for rusfertide. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release.  Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

     

    PROTAGONIST THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (Amounts in thousands except share and per share data)







    Three Months Ended 



    Nine Months Ended





    September 30,



    September 30,





    2021



    2020



    2021



    2020

    License and collaboration revenue - related party



    $

    10,286



    $

    13,114



    $

    18,740



    $

    22,978

    Operating expenses:

























    Research and development (1)





    36,956





    15,995





    87,633





    55,020

    General and administrative (1)





    7,256





    4,891





    19,936





    13,644

    Total operating expenses





    44,212





    20,886





    107,569





    68,664

    Loss from operations





    (33,926)





    (7,772)





    (88,829)





    (45,686)

    Interest income





    122





    87





    321





    820

    Interest expense









    (19)









    (471)

    Loss on early repayment of debt

















    (585)

    Other expense, net









    (59)





    (136)





    (37)

    Loss before income tax expense





    (33,804)





    (7,763)





    (88,644)





    (45,959)

    Income tax expense

















    (1,305)

    Net loss



    $

    (33,804)



    $

    (7,763)



    $

    (88,644)



    $

    (47,264)

    Net loss per share, basic and diluted



    $

    (0.70)



    $

    (0.21)



    $

    (1.94)



    $

    (1.45)

    Weighted-average shares used to compute

    net loss per share, basic and diluted





    47,987,184





    37,386,881





    45,705,782





    32,647,524



    (1)                Amount includes non-cash stock-based compensation expense.

     

     

    PROTAGONIST THERAPEUTICS, INC.

    Stock-based Compensation (Unaudited)

    (In thousands)





    Three Months Ended



    Nine Months Ended



    September 30,



    September 30, 



    2021



    2020



    2021



    2020

    Research and development

    $

    2,611



    $

    1,006



    $

    6,241



    $

    3,098

    General and administrative



    2,164





    882





    5,130





    2,834

    Total stock-based compensation expense

    $

    4,775



    $

    1,888



    $

    11,371



    $

    5,932

     

     

    PROTAGONIST THERAPEUTICS, INC.

    Selected Consolidated Balance Sheet Data

    (In thousands)





    September 30,



    December 31,

    2021

    2020

    Cash, cash equivalents and marketable securities

    $

    352,470



    $

    307,809

    Working capital



    288,531





    275,365

    Total assets



    373,175





    324,468

    Deferred revenue-related party



    2,241





    14,477

    Accumulated deficit



    (372,455)





    (283,811)

    Total stockholders' equity



    329,660





    279,606

     

    Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

     

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  5. NEWARK, Calif., Oct. 26, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that it will receive a $7.5 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered by the completion of the clinical data collection-related Phase 1 activities for PN-235 (JNJ-2113). This investigational drug candidate is one of the three IL-23 receptor antagonists that are part of Protagonist's collaboration agreement with Janssen, which provides for concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications.

    "The completion of these Phase 1 activities reflects our continued strength of execution as our collaboration of four-plus years, encompassing…

    NEWARK, Calif., Oct. 26, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that it will receive a $7.5 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered by the completion of the clinical data collection-related Phase 1 activities for PN-235 (JNJ-2113). This investigational drug candidate is one of the three IL-23 receptor antagonists that are part of Protagonist's collaboration agreement with Janssen, which provides for concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications.

    "The completion of these Phase 1 activities reflects our continued strength of execution as our collaboration of four-plus years, encompassing three assets in parallel development for multiple indications, continues to make steady progress," said Dinesh Patel, PhD, President and Chief Executive Officer at Protagonist. "This latest milestone marks $87.5 million in total milestones we have earned to date through this strategic partnership with Janssen. Our teams are guided by a shared commitment to improving and expanding therapeutic options for the many patients who may one day benefit from the oral therapies we are advancing in development today."

    This collaboration provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of both IBD (inflammatory bowel disease) and non-IBD indications that can be treated through blockade of the IL-23 pathway. The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn's disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates. PN-232 and PN-235 are currently in Phase 1 clinical development. Future milestones for Phase 2 and Phase 3 successes are contemplated in the collaboration agreement, as are royalties for Protagonist on products from this portfolio that achieve market approval and entry.

    Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has exclusive, worldwide rights to develop and commercialize PTG-200, PN-232, PN-235 and any other second-generation compounds derived from this research collaboration. Protagonist will have the right to co-detail up to two licensed products in ulcerative colitis and CD in the U.S. market.

    About Protagonist Therapeutics

    Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development, all derived from the Company's proprietary technology platform. Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic which is currently in Phase 2 development for the treatment of polycythemia vera and hereditary hemochromatosis. The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) currently in a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.  In addition, Protagonist has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds included in this agreement are PTG-200, PN-235 and PN-232. PTG-200 is an orally delivered interleukin-23 receptor specific antagonist peptide which is currently in Phase 2 development for Crohn's disease. PN-235 and PN-232, both second-generation oral interleukin-23 receptor antagonist candidates, are currently in Phase 1 studies.  For further information, please visit www.protagonist-inc.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the Company's clinical collaboration with Janssen and the potential of collaboration compounds. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release.  Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

    Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

     

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