RXDX Prometheus Biosciences Inc.

26.23
+0.23  (+1%)
Previous Close 26
Open 26.17
52 Week Low 16.11
52 Week High 30.64
Market Cap $1,019,454,813
Shares 38,865,986
Float 29,995,596
Enterprise Value $673,102,010
Volume 12,918
Av. Daily Volume 75,372
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Upcoming Catalysts

Drug Stage Catalyst Date
PRA023 (ARTEMIS-UC)
Ulcerative colitis
Phase 2
Phase 2
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PRA023 (APOLLO-CD)
Crohn’s Disease
Phase 2a
Phase 2a
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Latest News

  1. SAN DIEGO, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), today announced that Mark McKenna, Chairman and Chief Executive Officer and Allison Luo, M.D., Chief Medical Officer, will participate in a fireside chat at the Jefferies Virtual Next Generation IBD Therapeutics Summit on Tuesday, October 19, 2021 at 11:30 a.m. ET.

    A live and archived webcast of the fireside chat will be available via the Events & Webcasts section of the Prometheus Biosciences website. A replay of the presentation will be available for 30 days following the event.

    About Prometheus Biosciences

    Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development…

    SAN DIEGO, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), today announced that Mark McKenna, Chairman and Chief Executive Officer and Allison Luo, M.D., Chief Medical Officer, will participate in a fireside chat at the Jefferies Virtual Next Generation IBD Therapeutics Summit on Tuesday, October 19, 2021 at 11:30 a.m. ET.

    A live and archived webcast of the fireside chat will be available via the Events & Webcasts section of the Prometheus Biosciences website. A replay of the presentation will be available for 30 days following the event.

    About Prometheus Biosciences

    Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD). The Company's precision medicine platform, Prometheus360, combines proprietary machine learning-based analytical approaches with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.

    The Company's lead candidate, PRA023, is an IgG1 humanized monoclonal antibody (mAb) for the treatment of the two most common forms of IBD, Ulcerative Colitis (UC) and Crohn's Disease (CD).  The Company has initiated enrollment in a Phase 2 trial in UC patients and a Phase 2a trial in CD patients, each utilizing a genetic-based companion diagnostic designed to identify patients more likely to respond to PRA023. 

    Prometheus Biosciences Contact:

    Noel Kurdi

    VP Investor Relations and Communications

    (646) 241-4400

    nkurdi@prometheusbiosciences.com

    Media Contact:

    Jake Robison

    CanaleComm, an Ashfield Health Company

    (619) 849-5383

    jake.robison@canalecomm.com



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  2. - Initiated Phase 2 study of PRA023 and its companion diagnostic in Ulcerative Colitis (UC) and Phase 2a study of PRA023 and its companion diagnostic in Crohn's disease (CD) -

    - Phase 1a trial results of PRA023 in normal healthy volunteers expected in fourth quarter 2021 -

    - Strong cash position of $304 million as of June 30, 2021 -

    SAN DIEGO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today reported financial results…

    - Initiated Phase 2 study of PRA023 and its companion diagnostic in Ulcerative Colitis (UC) and Phase 2a study of PRA023 and its companion diagnostic in Crohn's disease (CD) -

    - Phase 1a trial results of PRA023 in normal healthy volunteers expected in fourth quarter 2021 -

    - Strong cash position of $304 million as of June 30, 2021 -

    SAN DIEGO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today reported financial results for the quarter ended June 30, 2021, and highlighted recent corporate progress.

    "Our team has made tremendous progress in the last several months with a continued focus on achieving our corporate milestones, most importantly, the initiation of the Phase 2 and Phase 2a studies for our lead program, PRA023, in Ulcerative Colitis and Crohn's disease, as well as the achievement of a significant partnering milestone which further validates our platform," said Mark McKenna, President and CEO of Prometheus. "As we look ahead, the team is highly focused on rapidly enrolling and executing our clinical trials, while also expanding our precision-medicine approach to other immune-mediated diseases beyond IBD."

    Second Quarter 2021 and Recent Corporate Highlights

    Initiated global Phase 2 ARTEMIS-UC clinical trial of PRA023 in Ulcerative Colitis (UC). Prometheus' Phase 2 ARTEMIS-UC clinical trial is currently enrolling patients with moderate-to-severely active UC who have failed conventional therapy, including biologics. The trial is a 12-week, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of PRA023 in patients with UC. The initial cohort is statistically powered to evaluate the efficacy of PRA023 in patients with UC. The expansion cohort is statistically powered to further evaluate the effectiveness of a companion diagnostic in patients with UC. Topline results for the Phase 2 ARTEMIS-UC trial are expected in 4Q 2022.

    Initiated global Phase 2a APOLLO-CD clinical trial of PRA023 in Crohn's disease (CD). Prometheus' Phase 2a APOLLO-CD clinical trial is a 12-week open label study that is currently enrolling patients with moderate-to-severely active CD with endoscopically active disease who have failed conventional therapy, including biologics. The study will assess the efficacy of PRA023 and the effectiveness of the companion diagnostic in patients with CD. Topline results for the Phase 2a APOLLO-CD trial are expected in 4Q 2022.

    Provided clinical updates of lead program, PRA023, at R&D Day. Prometheus recently held its first R&D Day and provided updates from the Phase 1a clinical trial of PRA023 in normal healthy volunteers and debuted the design of the Phase 2 and Phase 2a trial designs in patients with UC and CD.

    • PRA023 was well-tolerated during the dosing phase of the Phase 1a study in normal healthy volunteers with no clinically meaningful safety signal identified, supporting the initiation of the ongoing Phase 2 and Phase 2a trials
    • 6-month toxicity study was completed with no dose-limiting toxicity, enabling evaluation of long-term dosing

    Received $10M milestone payment from Dr. Falk Pharma for PR600. Prometheus achieved a significant milestone in its collaboration with Dr. Falk Pharma GmbH with the selection of a clinical candidate in the PR600 program, which targets an undisclosed member of the tumor-necrosis factor superfamily for the treatment of IBD. The company expects to file an Investigational New Drug application (IND) for PR600 in 3Q 2022.

    Strengthened board of directors with appointment of Fred Hassan. Prometheus appointed Mr. Hassan, the former CEO of Schering-Plough and former Chairman of Bausch & Lomb, in May 2021.

    Upcoming Milestones and Events

    • Phase 1a trial results of PRA023 in normal healthy volunteers expected in 4Q 2021
    • New indication announcement for PRA023 in 4Q 2021
    • Investigational Device Exemption (IDE) submission of the companion diagnostic for PRA023 in 3Q 2022
    • IND to be filed for PR600 in 3Q 2022
    • Topline results from the ARTEMIS-UC Phase 2 study expected in 4Q 2022
    • Topline results from APOLLO-CD Phase 2a study expected in 4Q 2022

    Second Quarter 2021 Financial Results

    Cash and Cash Equivalents. As of June 30, 2021, Prometheus Biosciences had cash and cash equivalents of $304.4 million, compared to $54.2 million at the end of 2020. We received net proceeds of $73.7 million from the sale of shares of our Series D-2 convertible preferred stock and net proceeds of $199.8 million from the sale of our common stock in our IPO, both in the first quarter.

    Collaboration Revenue. Revenue was $0.3 million for the second quarter ended June 30, 2021, compared to $0.2 million for the second quarter ended June 30, 2020, and $1.1 million for the first half of 2021 compared to $0.4 million for the first half of 2020, primarily due to additional revenue generated from Prometheus' collaboration with Dr. Falk Pharma.

    Research and Development Expenses. Research and development expenses were $13.6 million for the second quarter ended June 30, 2021, compared to $4.9 million for the second quarter ended June 30, 2020, and $21.3 million for the first half of 2021 compared to $9.2 million for the first half of 2020. The increases were primarily driven by advancement of PRA023 into the clinical stage of development, as well as advancing our other development programs.

    General and Administrative Expenses. General and administrative expenses were $5.6 million for the second quarter ended June 30, 2021, compared to $1.8 million for the second quarter ended June 30, 2020, and $10.8 million for the first half of 2021 compared to $4.2 million for the first half of 2020. The increases were primarily due to an increase in expenses related to operating as a public company and an increase in personnel.

    About PRA023

    PRA023 is an IgG1 humanized monoclonal antibody (mAb) that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membrane-associated human TL1A with high affinity and specificity and has the potential to substantially improve outcomes for moderate-to-severe IBD patients predisposed to increased TL1A expression. Prometheus is developing PRA023 for the treatment of the two most common forms of IBD, Ulcerative Colitis (UC) and Crohn's disease (CD). The Company has initiated enrollment in a Phase 2 trial in UC patients and a Phase 2a trial in CD patients, each utilizing a genetic-based companion diagnostic designed to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.

    About Prometheus Biosciences

    Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD). The Company's precision medicine platform, Prometheus360™, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is headquartered in San Diego, CA.

    Forward Looking Statements

    Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on our current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential to rapidly enroll and execute our clinical trials and expand our approach to other immune-mediated diseases beyond IBD; and Prometheus' expected timing of topline results for its Phase 2 and 2a trials, Phase 1a study results and new indication announcement for PRA023, IDE submission for the companion diagnostic, and to file an IND for PR600. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: Prometheus' approach to the discovery and development of precision medicines based on Prometheus360™ is unproven, and the company may not be able to develop any therapeutics or companion diagnostic products of commercial value; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies, including due to the COVID-19 pandemic; Prometheus' dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing, and potential supply chain disruptions related to the COVID-19 pandemic; Prometheus' ability to develop a companion diagnostic for PRA023; the success of clinical trials and preclinical studies for its product candidates and companion diagnostics; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; regulatory developments in the United States and foreign countries; Prometheus may not realize any benefits from our collaboration with Dr. Falk; and other risks described in our prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our most recent quarterly report on Form 10-Q and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.



    Prometheus Biosciences, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited)

    (in thousands, except share and per share data)

     Three Months Ended  Six Months Ended 
     June 30,  June 30, 
     2021  2020  2021  2020 
                    
    Collaboration revenue$326  $179  $1,086  $407 
    Operating expenses:               
    Research and development 13,554   4,923   21,312   9,188 
    General and administrative 5,618   1,810   10,840   4,197 
    Total operating expenses 19,172   6,733   32,152   13,385 
    Loss from operations (18,846)  (6,554)  (31,066)  (12,978)
    Other income (expense), net (153)  (597)  (1,878)  (1,127)
    Loss from continued operations (18,999)  (7,151)  (32,944)  (14,105)
    Loss from discontinued operations   (1,289)    (7,463)
    Net loss$(18,999) $(8,440) $(32,944) $(21,568)
    Net loss per share, basic and diluted               
    Continued operations$(0.49) $(5.02) $(1.39) $(10.08)
    Discontinued operations$  $(0.90) $  $(5.34)
    Net loss per share, basic and diluted$(0.49) $(5.93) $(1.39) $(15.42)
    Weighted average common shares outstanding - basic and diluted 38,813,865   1,424,445   23,660,559   1,398,748 



    Prometheus Biosciences, Inc.

    Condensed Consolidated Balance Sheets 

    (unaudited)

    (in thousands)

      June 30, 2021  December 31, 2020 
    Assets        
    Cash, cash equivalents $304,389  $54,201 
    Other current assets  7,200   3,255 
    Total current assets  311,589   57,456 
    Other assets  1,577   2,177 
    Total assets $313,166  $59,633 
             
    Liabilities and Stockholders' Equity        
    Current liabilities $17,698  $15,255 
    Long-term liabilities  13,040   15,896 
    Total liabilities  30,738   31,151 
    Convertible preferred stock    126,023 
    Total stockholders' equity  282,428   (97,541)
    Total liabilities and stockholders' equity $313,166  $59,633 

     

    Company Contact:

    Noel Kurdi

    VP Investor Relations and Communications

    (646) 241-4400

    nkurdi@prometheusbiosciences.com

    Media Contact:

    Jake Robison

    CanaleComm, an Ashfield Health Company

    (619) 849-5383

    jake.robison@canalecomm.com



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  3. SAN DIEGO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), with great sorrow announced today that its Chairman of the Board, Tadataka (Tachi) Yamada, M.D., KBE, passed away unexpectedly on August 4, 2021.

    "As I reflect on my time with Tachi, one word in the forefront of my mind is impact. His passion for identifying and solving big problems in healthcare and biotech, as well as his penchant for impacting humanity, is evident in his legacy of professional and academic achievements. There are few others whose work has touched so many lives," said Mark McKenna, President and CEO of Prometheus Biosciences. "On behalf of the Board of Directors, Prometheus management team and employees, we deeply mourn his loss and…

    SAN DIEGO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), with great sorrow announced today that its Chairman of the Board, Tadataka (Tachi) Yamada, M.D., KBE, passed away unexpectedly on August 4, 2021.

    "As I reflect on my time with Tachi, one word in the forefront of my mind is impact. His passion for identifying and solving big problems in healthcare and biotech, as well as his penchant for impacting humanity, is evident in his legacy of professional and academic achievements. There are few others whose work has touched so many lives," said Mark McKenna, President and CEO of Prometheus Biosciences. "On behalf of the Board of Directors, Prometheus management team and employees, we deeply mourn his loss and extend our sympathies to his family."

    Over the course of his career, Dr. Yamada left an impact on many lives as a physician scientist who became a pillar of the healthcare community and a luminary leader and mentor for many companies. He had served as Prometheus' Board Chair since June 2018 and as a Venture Partner at Frazier Life Sciences since June 2015. He was a co-founder of and served as Chair of the Board of Directors for Phathom Pharmaceuticals, Passage Bio and Scout Bio. He also served as Chair of Icosavax and served as member of the Board of Directors of Agilent Technologies, Inc., Takeda Pharmaceutical Company Ltd, GlaxoSmithKline Inc., and CSL Limited.

    Before joining Frazier, Dr. Yamada was Chief Medical and Scientific Officer at Takeda Pharmaceuticals in Tokyo, as well as a member of the Board of Directors, where he was responsible for all of Takeda's research & development activities. Prior to Takeda, Dr. Yamada was President of the Bill & Melinda Gates Foundation Global Health Program in Seattle, where he oversaw over $9 billion in grants for applying technologies to address major health challenges of the developing world.

    About Prometheus Biosciences

    Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD). The Company's precision medicine platform, Prometheus360, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is headquartered in San Diego, CA.

    Prometheus Biosciences Contact:

    Noel Kurdi

    VP Investor Relations and Communications

    (646) 241-4400

    nkurdi@prometheusbiosciences.com

    Media Contact:

    Jake Robison

    CanaleComm, an Ashfield Health Company

    (619) 849-5383

    jake.robison@canalecomm.com

     



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  4. - First Anti-TL1A trial in Crohn's Disease -

    - APOLLO-CD Phase 2a along with ARTEMIS-UC Phase 2 topline results expected in fourth quarter 2022 -

    - Final Phase 1a results for PRA023 in normal healthy volunteers expected in fourth quarter 2021-

    SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) --  Prometheus Biosciences, Inc. (NASDAQ:RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the APOLLO-CD Phase 2a clinical trial evaluating PRA023 for moderate-to-severe Crohn's disease…

    - First Anti-TL1A trial in Crohn's Disease -

    - APOLLO-CD Phase 2a along with ARTEMIS-UC Phase 2 topline results expected in fourth quarter 2022 -

    - Final Phase 1a results for PRA023 in normal healthy volunteers expected in fourth quarter 2021-

    SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) --  Prometheus Biosciences, Inc. (NASDAQ:RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the APOLLO-CD Phase 2a clinical trial evaluating PRA023 for moderate-to-severe Crohn's disease (CD), with first patient enrollment.  

    "We are excited to advance PRA023 into the APOLLO-CD Phase 2a study as we believe its novel mechanism of action, designed to address both inflammation and fibrosis, can have a significant impact on patients suffering with Crohn's disease," said Allison Luo, MD, Chief Medical Officer of Prometheus. "We believe PRA023 has the potential to address the highest unmet need of fibrostenotic disease in this patient population."

    The APOLLO-CD Phase 2a trial is an open-label study designed to evaluate the proof-of-concept efficacy and safety of PRA023 in moderate-to-severe Crohn's disease with centrally read endoscopy as the primary endpoint. Dosing regimen of the 50 subjects in the study will consist of 1,000 mg on day 1, followed by 500 mg on weeks 2, 6, and 10 for a total of 12 weeks on therapy. The primary endpoint at week 12 will evaluate the proportion of patients achieving endoscopic improvement as defined by 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD), which assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each subject will also be assessed for the status of companion diagnostic (CDx) assay we are developing and subgroup analyses for all endpoints will be conducted based on CDx results.  

    "Clinicians and patients are excited about Prometheus' precision approach coupled with the anti-fibrotic mechanistic approach of the anti-TL1A therapy," said Dr. G. Aaron Duvall, gastroenterologist and investigator at Tyler Research Institute. "I am thrilled to participate in both the ulcerative colitis and Crohn's disease studies to help bring this novel therapeutic approach, with the use of a companion diagnostic, to patients."

    Prometheus has recently completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers. Safety and tolerability observed to date supports the initiation of this Phase 2a trial.   Final Phase 1a results of PRA023 are expected in the fourth quarter of 2021. Separately, Prometheus recently initiated and dosed the first patient in the ARTEMIS-UC Phase 2 trial to evaluate the efficacy and safety of PRA023 in moderate-to-severe ulcerative colitis (UC) patients.

    About PRA023

    PRA023 is an IgG1 humanized monoclonal antibody (mAb) that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membrane-associated human TL1A with high affinity and specificity and has the potential to substantially improve outcomes for moderate-to-severe IBD patients predisposed to increased TL1A expression. Prometheus is developing PRA023 for the treatment of the two most common forms of IBD, UC and CD. The Company has initiated enrollment in a Phase 2 trial in UC patients and a Phase 2a trial in CD patients, each utilizing a genetic-based companion diagnostic designed to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.

    About Prometheus Biosciences

    Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of immune-mediated diseases, starting first with IBD. The Company's precision medicine platform, Prometheus360TM, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.  Prometheus is headquartered in San Diego, CA.

    Forward Looking Statements

    Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the potential of PRA023 and a companion diagnostic to address a high unmet need for patients; and the timing of Prometheus reporting the final study results from its Phase 1a clinical trial of PRA023. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: Prometheus' approach to the discovery and development of precision medicines based on Prometheus360TM is unproven, and the Company may not be able to develop any therapeutics or companion diagnostic products of commercial value; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; Prometheus' dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus' ability to develop a companion diagnostic for PRA023; the success of clinical trials and preclinical studies for its product candidates and companion diagnostic; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; regulatory developments in the United States and foreign countries; Prometheus' ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; Prometheus' ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain; and other risks described in the Company's prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Prometheus' most recent quarterly report on Form 10-Q and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Prometheus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts:

    Noel Kurdi

    VP Investor Relations and Communications

    (646) 241-4400

    nkurdi@prometheusbiosciences.com

    Media contact:

    Juniper Point

    Amy Conrad

    (858) 914-1962

    media@prometheusbiosciences.com



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  5. -First precision approach to IBD by utilizing a companion diagnostic to identify patients-

    -Phase 2a initiation in Crohn's Disease on track for 3rd Quarter 2021-

    - Further details to be provided at R&D Day on July 28th-

    SAN DIEGO, July 19, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment…

    -First precision approach to IBD by utilizing a companion diagnostic to identify patients-

    -Phase 2a initiation in Crohn's Disease on track for 3rd Quarter 2021-

    - Further details to be provided at R&D Day on July 28th-

    SAN DIEGO, July 19, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (NASDAQ:RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the Phase 2 ARTEMIS-UC clinical trial evaluating PRA023 for moderate-to-severe ulcerative colitis (UC), with first patient enrollment. The study is placebo-controlled and statistically powered to evaluate the efficacy and safety of PRA023 in UC patients.   The company plans to provide more details of the Phase 2 ARTEMIS-UC study at R&D Day on July 28th.

    "The majority of patients with UC cannot achieve clinical remission through the use of currently available therapies," said Allison Luo, MD, Chief Medical Officer of Prometheus. "This gives Prometheus compelling motivation to rapidly advance PRA023, addressing both inflammation and fibrosis and leading the precision medicine approach in the IBD space, starting first with the ARTEMIS-UC study."

    Prometheus has recently completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers. Safety and tolerability observed to date supports the initiation of a Phase 2 trial. Final Phase 1a results of PRA023 in UC and CD are expected in the fourth quarter of 2021. Further details will be provided at the company's R&D Day on July 28, 2021. Register here: Prometheus R&D Day

    About PRA023

    PRA023 is an IgG1 humanized monoclonal antibody (mAb) that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membrane-associated human TL1A with high affinity and specificity and has the potential to substantially improve outcomes for moderate-to-severe IBD patients predisposed to increased TL1A expression. Prometheus is developing PRA023 for the treatment of the two most common forms of IBD, Ulcerative Colitis (UC) and Crohn's Disease (CD). The Company has initiated enrollment in a Phase 2 trial in UC patients. The Company is also developing a genetic-based companion diagnostic to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.

    About Prometheus Biosciences

    Prometheus Biosciences, Inc. is a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of immune-mediated diseases, starting first with IBD. The Company's precision medicine platform, Prometheus360™, combines proprietary bioinformatics discovery methods with one of the world's largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.  Prometheus is headquartered in San Diego, CA.

    Forward Looking Statements

    Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the timing of commencement of Prometheus' Phase 2 clinical trial in UC and its Phase 2a clinical trial in CD; Prometheus' Enroll360™ program and the company's ability to accelerate enrollment in its planned and other future clinical trials; and the timing of Prometheus obtaining the final study results from its Phase 1a clinical trial of PRA023. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: Prometheus' approach to the discovery and development of precision medicines based on Prometheus360™ is unproven; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; Prometheus' dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus' ability to develop companion diagnostics for our therapeutic product candidates; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; Prometheus may not realize any benefits from our current and any future collaborations; regulatory developments in the United States and foreign countries; Prometheus' ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; Prometheus' ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Prometheus' most recent quarterly report on Form 10-Q and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Prometheus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

    Contacts:

    Noel Kurdi

    VP Investor Relations and Communications

    (646) 241-4400

    nkurdi@prometheusbiosciences.com

    Media contact:

    Juniper Point

    Amy Conrad

    (858) 914-1962

    media@prometheusbiosciences.com



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