Protagonist Announces Nomination of PN-477, an Oral and Injectable GLP-1R, GIPR, and GCGR Triple Agonist Peptide Development Candidate for Obesity
Company will also develop a subcutaneous version, PN-477sc, as a once-weekly injection
IND-enabling studies underway, with Phase I study initiation expected in 2Q26
Webcast and conference call to be held today at 4:30 pm ET
Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced the selection of PN-477, a potential best-in-class GLP-1, GIP, GCG receptor triple agonist peptide with oral and subcutaneous routes of administration, as a development candidate for the treatment of obesity. The triple agonist PN-477 is designed to offer the optimal combination of total body weight loss, improved gastrointestinal (GI) tolerability and fat to lean mass ratio, with the dosing convenience of a once-daily oral agent and the added optionality of a once-weekly subcutaneous administration.
'We are very pleased to nominate development candidate PN-477, a promising potential best-in class oral GLP-1, GIP, GCG receptor tri-agonist peptide which has demonstrated optimal absolute and relative activity against all three hormone receptors in preclinical testing,' said Dinesh V. Patel, PhD, President and CEO of Protagonist. 'PN-477 is specifically engineered to be orally stable with attention to the relative balance of potencies against the three receptors to potentially leverage their beneficial effects on weight loss and optimal body composition while mitigating their adverse effects. As with our previous drug candidates and late-stage assets, PN-477 is a testament to the power of our peptide technology platform, including the ability to deliver first- and best-in-class targeted oral and injectable peptide therapeutics.'
PN-477 has completed extensive preclinical evaluation including oral and metabolic stability, potency, pharmacokinetics and pharmacodynamics studies, and has demonstrated effects in preclinical models of obesity and glycemic control. PN-477 has shown potent in vitro activity in activating the GLP-1, GIP, and GCG receptors. PN-477 also demonstrated robust preclinical proof-of-concept in various animal studies including the diet induced obesity (DIO) preclinical mouse model, normal dogs, and cynomolgus monkeys. Overall, PN-477 has the right balance of potency, oral and in-vivo stability, and pharmacokinetic properties to enable parallel development both as a once-daily oral (PN-477o) and once-weekly injectable (PN-477sc) treatment options. IND enabling studies of PN-477 are underway and initiation of Phase 1 clinical studies is anticipated in the second quarter of 2026.
'While GLP-1 agonists have dominated the market thus far, there remains a broad opportunity for novel therapeutics with better body weight loss, higher ratio of fat to lean mass loss, tolerability and additional beneficial effects in obesity-related comorbidities. A triple GLP-1, GIP, GCG receptor agonist peptide that offers weight loss on par with the best injectable treatments options, as well as the optionality provided by both oral and injectable routes of administration, would be an important therapeutic breakthrough and represents another potential blockbuster drug opportunity for Protagonist,' added Dr. Patel. 'We look forward to moving PN-477 into first-in human clinical Phase 1 studies in the second quarter of 2026.'
Conference Call and Webcast Details
The dial-in numbers for Protagonist's investor update on Monday, June 30th at 4:30 pm ET are:
US-based Investors: 1-877-407-0752
International Investors: 1-201-389-0912
Conference Call ID: 13754335
The webcast link for the event can be found here: https://viavid.webcasts.com/starthere.jsp?ei=1724439&tp_key=584cdd1e86
A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage following the event.
About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to J&J Innovative Medicines ('JNJ'), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and oral hepcidin.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://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 the potential benefits of PN-477, and the timing of PN-477 clinical development. 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 with Janssen and Takeda, 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.
Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext. 1
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
an hour ago
- Business Wire
IntegraGen: Sales of €2.5 Million in the First Half of 2025 and Cash Position of €2.1 Million
EVRY, France--(BUSINESS WIRE)--Regulatory News: IntegraGen (FR0010908723 – ALINT – Eligible PEA PME), an OncoDNA company specializing in the genomics of cancer and rare genetic diseases, which performs interpretable genomic analyses for academic and private laboratories, announces today its unaudited sales for the first half of 2024. Sales for the first half came to €2,540K, down 34% compared with the first half of 2024 on a like-for-like basis (excluding revenues from the SeqOIA platform), contrary to expectations of weak growth, comparable to that of 2024, as announced by the Company in its press release dated April 29, 2025, on its results for the 2024 financial year. This decline is the result of reduced activity of over 40% on the Institut Pasteur's Mutualized Microbiology platform, linked to the drop in epidemiological sequencing, as well as to the decline in projects carried out on the Evry genomics platform, down by around 31%. This decline is the result of delays in the start-up of two major projects, the first samples of which were received by the company in May, as well as a general slowdown in research projects for academic and hospital customers. The company believes that the second half of the year, with the acceleration of major projects (notably UMBRELLA) and improved funding conditions for public research, should enable the situation to improve from the third quarter onwards. As of June 30 th, available cash, including the remainder on the loan granted to the parent company OncoDNA and repaid over the course of 2025, stood at €2.1m. The company used up €0.9m of cash in the first half of 2025, and at this rate may not have enough cash to ensure its financing for the next 12 months. In this context, the company is exploring all strategic options to improve its situation and expects to reduce cash consumption in the second half of the year through the reduction of operating costs, the launch of services for several existing customers, external sources of financing, a resumption of customer research projects, as well as the expected upturn in customers' research budgets. Given the high level of uncertainty surrounding public research funding, the Company is not maintaining its revenue growth forecasts for 2025. Bernard Courtieu, Chief Executive Officer of IntegraGen, comments: "The first half of the year has been extremely difficult, with both a sharp drop in academic and hospital research projects, linked to a reduction in public research financing, as well as a reduction in the budgets of several biotech companies in a sector affected by the general economic climate. Despite several successes such as the UMBRELLA project, whose operational launch was announced last month, IntegraGen needs to find new sources of funding to be able to ensure the continuity of its operations." Investors are invited to carefully read section 4.2 of the 2024 Management Report on 'Principal risks and uncertainties facing the Company'. Financial results for the first half of 2025 will be published in October. ABOUT INTEGRAGEN IntegraGen is an OncoDNA group company specializing in the genomics of cancer and rare genetic diseases. Backed by highly competent and qualified teams, IntegraGen is a leading player in DNA sequencing services and genomic data interpretation software. The company runs one of the largest NGS labs in France and operates for research institutes of excellence. As part of OncoDNA group, IntegraGen leverages the power of next generation sequencing with the mission of delivering the promise of precision medicine to patients. IntegraGen has about 40 employees and generated €8.5 million of turnover in 2024. Based in France, IntegraGen is part of the Belgian OncoDNA group present in Spain, UK, Germany and works with an international network of 35 distributors. The Group also provides biomarker testing and clinical interpretation tools to guide treatment and monitoring of late stage solid tumors and accelerate the development of new cancer drugs. IntegraGen is listed on Euronext Growth in Paris (ISIN: FR0010908723 – Mnemo: ALINT – Eligible PEA- PME).
Business Insider
3 hours ago
- Business Insider
Lotus Technology announces Etika exercised its put option
Lotus Technology (LOT) announced that Etika Automotive exercised its put option on June 30 requiring us to purchase 49% of the equity interests in Lotus Advance Technologies held by Etika pursuant to the Put Option Agreement dated January 31, 2023 between the parties. Lotus UK is currently owned by Geely International and Etika. As announced on April 14 Geely HK exercised a similar put option granted to it by the Company. With Etika having exercised its put option, the Company is expected to acquire 100% of the equity interests of Lotus UK through non-cash transactions based on pre-agreed prices. Upon completion, the Company will gain control over Lotus UK and consolidate its financial results. Lotus UK controls the manufacturing operations of Lotus' sportscars and hyper cars, and Lotus Engineering which provides comprehensive consultancy services to many of the OEMs and Tier 1 suppliers around the world. The acquisition is expected to be completed by 2025. In conjunction with the business combination between the Company and L Catterton Asia Acquisition Corp, a special purpose acquisition company affiliated with L Catterton, a leading global consumer-focused investment firm, the Company and Lotus UK entered into a Put Option Agreement with each of Geely HK and Etika. Pursuant to these agreements, each of Geely HK and Etika was granted the right to require the Company to acquire its equity interest in Lotus UK at a pre-agreed pricing method1 and upon satisfaction of the condition that the total number of vehicles sold by Lotus UK and its subsidiaries shall exceed 5,000 in 2024, with the exercise of such options by Geely HK and Etika not cross-conditioned on one another. As of December 31, 2024, the Put Option Exercise Condition had been satisfied.
Business Wire
3 hours ago
- Business Wire
AeroVironment, Inc. Announces Pricing of Upsized Offerings of Common Stock And 0% Convertible Senior Notes Due 2030
ARLINGTON, Va.--(BUSINESS WIRE)--AeroVironment, Inc. (NASDAQ: AVAV) (the 'Company') today announced the pricing of its upsized underwritten public offering of 3,528,226 shares of its common stock (the 'Common Stock') at a public offering price of $248.00 per share (such offering, the 'Common Stock Offering'), and its upsized underwritten public offering of $650,000,000 aggregate principal amount of its 0% convertible senior notes due 2030 (the 'Convertible Notes' and such offering, the 'Convertible Notes Offering'). The aggregate net proceeds to the Company from the Common Stock Offering and the Convertible Notes Offering, after deducting underwriting discounts and other estimated offering expenses, are expected to be approximately $1.47 billion. The Company expects to use approximately $965.3 million of the net proceeds from the Common Stock Offering and the Convertible Notes Offering to repay indebtedness under its term loan and outstanding borrowings under its revolving credit facility, and the remainder for general corporate purposes, including to increase manufacturing capacity. The Company has granted the underwriters of the offerings a 30-day option to purchase up to an additional 529,234 shares of Common Stock at the public offering price less the underwriting discount in the Common Stock Offering and a 30-day option to purchase up to an additional $97,500,000 aggregate principal amount of Convertible Notes solely to cover over-allotments, if any, in the Convertible Notes Offering. The Convertible Notes will be convertible at the option of the holders if certain conditions are met and during certain periods, based on an initial conversion rate of 3.1017 shares of Common Stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $322.40 per share of Common Stock, representing a premium of approximately 30% above the public offering price per share of Common Stock in the Common Stock Offering. The Company will settle conversions of the Convertible Notes by paying or delivering, as applicable, cash or a combination of cash and shares of Common Stock, at the Company's election. Both the Common Stock Offering and the Convertible Notes Offering are expected to close on July 3, 2025, in each case, subject to satisfaction of customary closing conditions. The closing of neither the Common Stock Offering nor the Convertible Notes Offering is conditioned upon the closing of the other offering. J.P. Morgan and BofA Securities are acting as lead book-running managers and as representatives of the underwriters for the Common Stock Offering and the Convertible Notes Offering. Raymond James, RBC Capital Markets, William Blair, Baird and BNP Paribas are acting as joint book-running managers for the Common Stock Offering and the Convertible Notes Offering. BTIG, Citizens Capital Markets and BMO Capital Markets are acting as co-managers for the Common Stock Offering. US Bancorp, Citizens Capital Markets and BMO Capital Markets are acting as co-managers for the Convertible Notes Offering. The Company has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the 'SEC') as well as preliminary prospectus supplements with respect to each of the offerings to which this communication relates. Before you invest, you should read the applicable preliminary prospectus supplement and the prospectus in that registration statement and other documents the Company has filed with the SEC for more complete information about the Company and these offerings. You may obtain these documents by visiting EDGAR on the SEC's website at Alternatively, the Company, any underwriter or any dealer participating in the applicable offering will arrange to send you the applicable preliminary prospectus supplement (or, when available, the applicable final prospectus supplement) and the accompanying prospectus upon request to: J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or email: prospectus-eq_fi@ and postsalemanualrequests@ or BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, or e-mail: This press release does not constitute an offer to sell or a solicitation of an offer to buy the shares of Common Stock, the Convertible Notes, any shares of Common Stock issuable upon conversion of the Convertible Notes or any other securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration and qualification under the securities laws of such state or jurisdiction. ABOUT AEROVIRONMENT, INC. AeroVironment (NASDAQ: AVAV) is a defense technology leader delivering integrated capabilities across air, land, sea, space, and cyber. The Company develops and deploys autonomous systems, precision strike systems, counter-UAS technologies, space-based platforms, directed energy systems, and cyber and electronic warfare capabilities—built to meet the mission needs of today's warfighter and tomorrow's conflicts. With a national manufacturing footprint and a deep innovation pipeline, the Company delivers proven systems and future-defining capabilities with speed, scale, and operational relevance. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Certain of the statements contained or referred to herein, including those regarding the proposed offerings, should be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by words such as 'anticipate,' 'approximate,' 'believe,' 'plan,' 'estimate,' 'expect,' 'project,' 'could,' 'should,' 'strategy,' 'will,' 'intend,' 'may' and other similar expressions or the negative of such words or expressions. Statements in this press release concerning the Common Stock Offering and the Convertible Notes Offering, our ability to complete such offerings on the anticipated timeline or at all and the anticipated use of the net proceeds therefrom, together with other statements that are not historical facts, are forward-looking statements that are estimates reflecting management's best judgment based upon currently available information. Such forward-looking statements are inherently uncertain, and stockholders and other potential investors must recognize that actual results may differ materially from expectations as a result of a variety of factors. Such forward-looking statements are based upon management's current expectations and include known and unknown risks, uncertainties and other factors, many of which the Company is unable to predict or control, that may cause actual results, performance or plans to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the Company's ability to perform under existing contracts and obtain additional contracts; changes in the regulatory environment; the activities of competitors; failure of the markets in which the Company operates to grow; failure to expand into new markets; failure to develop new products or integrate new technology with current products; and general economic and business conditions in the United States and elsewhere in the world, as well as those set forth in AeroVironment, Inc.'s Annual Report on Form 10-K for the year ended April 30, 2025 (especially in Part I, Item 1A. Risk Factors and Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations), and other risks and uncertainties listed from time to time in the Company's other filings with the SEC. Other unknown or unpredictable factors also could have a material adverse effect on the Company's business, financial condition, results of operations and prospects. Accordingly, readers should not place undue reliance on these forward-looking statements. These forward-looking statements are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. The Company does not assume any obligation to publicly update or supplement any forward-looking statement to reflect actual results, changes in assumptions or changes in other factors affecting these forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statement.
