PTGX

Protagonist Therapeutics (PTGX) could be a solid addition to your portfolio given a notable revision in the company's earnings estimates. While the stock has been gaining lately, the trend might continue since its earnings outlook is still improving. The upward trend in estimate revisions for this biopharmaceutical company reflects growing optimism of analysts on its earnings prospects, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. Our stock rating tool -- the Zacks Rank -- has this insight at its core. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. For Protagonist Therapeutics, there has been strong agreement among the covering analysts in raising earnings estimates, which has helped push consensus estimates considerably higher for the next quarter and full year. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: The company is expected to earn $2.15 per share for the current quarter, which represents a year-over-year change of +446.8%. The Zacks Consensus Estimate for Protagonist Therapeutics has increased 8.45% over the last 30 days, as one estimate has gone higher while one has gone lower. For the full year, the earnings estimate of $3.69 per share represents a change of +280.0% from the year-ago number. The revisions trend for the current year also appears quite promising for Protagonist Therapeutics, with one estimate moving higher over the past month compared to no negative revisions. The consensus estimate has also received a boost over this time frame, increasing 26.02%. Thanks to promising estimate revisions, Protagonist Therapeutics currently carries a Zacks Rank #2 (Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision.You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (Strong Buy) and 2 (Buy) significantly outperform the S&P 500. While strong estimate revisions for Protagonist Therapeutics have attracted decent investments and pushed the stock 6.2% higher over the past four weeks, further upside may still be left in the stock. So, you may consider adding it to your portfolio right away. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Protagonist Therapeutics, Inc. (PTGX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Protagonist Therapeutics (PTGX) came out with quarterly earnings of $2.29 per share, beating the Zacks Consensus Estimate of $2.11 per share. This compares to a loss of $0.55 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +8.53%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.65 per share when it actually produced earnings of $0.05, delivering a surprise of +107.69%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Protagonist Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $213.48 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 3.12%. This compares to year-ago revenues of $5.55 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Protagonist Therapeutics shares have added about 55.5% since the beginning of the year versus the S&P 500's gain of 13%. While Protagonist Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Protagonist Therapeutics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.23 on $275.9 million in revenues for the coming quarter and $3.69 on $560.65 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Intellia Therapeutics, Inc. (NTLA), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This company is expected to post quarterly loss of $0.80 per share in its upcoming report, which represents a year-over-year change of +19.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Intellia Therapeutics, Inc.'s revenues are expected to be $14.51 million, up 1.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Protagonist Therapeutics, Inc. (PTGX) : Free Stock Analysis Report Intellia Therapeutics, Inc. (NTLA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

ICOTYDE™ First Full Quarter of Commercial Sales with Strong Early Adoption Rusfertide NDA under Priority Review for Polycythemia Vera; PDUFA Date in August 2026 Comprehensive Phase 2b Program with PN-881, an Oral IL-17 Antagonist for Psoriasis, Planned to Initiate Early Q1 2027 Phase 1 Study Initiated with PN-477sc, a Triple GLP1/GIP/GCG Agonist Peptide for Obesity Cash, Cash Equivalents and Marketable Securities of $849.5 Million as of June 30, 2026 NEWARK, CA / ACCESS Newswire / August 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the second quarter ended June 30, 2026 and provided a corporate update. "The second quarter of 2026 marked a defining growth phase for Protagonist with a successful commercial launch of ICOTYDE through our strategic partner and accelerating momentum across our internal R&D pipeline. ICOTYDE is quickly becoming a paradigm-shifting oral therapy for patients with moderate-to-severe plaque psoriasis, and rusfertide is approaching an FDA decision that could establish it as a first-in-class erythrocytosis targeted medicine for patients with polycythemia vera," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "Equally exciting is the decision to advance our wholly owned oral IL-17 antagonist PN-881 into a comprehensive Phase 2b psoriasis program, based on the strongly supportive pharmacokinetic results from the Phase 1 study. Behind PN-881, we have a maturing set of diverse assets moving toward clinical studies in obesity, hematology and immunology. These are the results of years of disciplined investment in differentiated science and mark the beginning, not the culmination, of a new phase of value creation as we continue to advance our peptide platform and clinical pipeline." Second Quarter 2026 Recent Developments and Upcoming Milestones Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) As announced on March 2nd, the NDA for rusfertide was accepted by the FDA and granted Priority Review in Q1 2026, with a PDUFA goal date in August 2026. Takeda holds exclusive worldwide development and commercialization rights to rusfertide following Protagonist's opt-out election in April 2026. As previously disclosed, this triggered a $200 million payment to Protagonist, with an additional $200 million opt-out fee and a separate $75 million milestone due upon FDA approval of rusfertide. The opt-out election also increased downstream economics payable to Protagonist, including up to $775 million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion. Protagonist continues to work closely with Takeda as the FDA completes its review. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation, and Fast Track designation from the FDA for polycythemia vera. On June 1, Protagonist announced four presentations of Phase 3 VERIFY and long-term rusfertide data at the 2026 European Hematology Association Congress, including patient-reported outcome data from VERIFY and long-term efficacy and safety data from the REVIVE and THRIVE studies. ICOTYDE™ (Icotrokinra): Oral IL-23 Receptor Antagonist On March 18, Protagonist announced that Johnson & Johnson received U.S. FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The approval triggered a $50 million milestone payment to Protagonist in the first quarter of 2026. The second quarter of 2026 represents ICOTYDE's first full quarter of commercial sales. Under the collaboration with Johnson & Johnson, Protagonist remains eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to the incremental annual sales above $4 billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasis. Wholly-Owned Clinical and Discovery Programs PN-881 (oral IL-17 antagonist peptide): Pharmacokinetic data from the Phase 1 study supports the decision to advance PN-881 into a comprehensive Phase 2 psoriasis program, with initiation expected in early Q1 2027. PN-477 (triple GLP1/GIP/GCG agonist peptide for obesity): Phase 1 study with the injectable (sc) PN-477 has begun, and initiation of a Phase 1 study with the oral (o) formulation of PN-477 is anticipated in first half of 2027. PN-458o (dual GLP/GIP agonist peptide): IND-enabling studies are ongoing with Phase 1 initiation anticipated in the second half of 2027. PN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in Q1 2027. Discovery: The Company continues to advance high-priority discovery programs including an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2026, were $849.5 million as compared to $646.0 million as of December 31, 2025. License and Collaboration Revenue: License and collaboration revenue of $213.5 million for second quarter of 2026 consisted primarily of (i) $192.4 million related to proportional recognition of the initial $200.0 million opt-out payment received from Takeda and (ii) $21.1 million for ongoing development services, including post opt-out wind down services, and rusfertide clinical supplies provided by us under the Takeda Collaboration Agreement and other revenues. License and collaboration revenue of $269.8 million for six months ended June 30, 2026 consisted primarily of (i) $192.4 million related to proportional recognition of the initial $200.0 million opt-out payment received from Takeda, (ii) $27.4 million for ongoing development services, including post opt-out wind down services, and rusfertide clinical supplies provided by us under the Takeda Collaboration Agreement and other revenues, and (iii) a $50.0 million milestone earned from JNJ in Q1 2026 upon FDA approval of ICOTYDE. License and collaboration revenue of $5.5 million for second quarter of 2025 consisted of (i) $5.0 million related to the initial transaction price of the Takeda collaboration agreement for development services provided by us, and (ii) $0.5 million related to the proportional recognition of the $25 million milestone earned in Q1 2025 but receivable following completion of the VERIFY clinical study report. License and collaboration revenue of $33.9 million for the six months ended June 30, 2025 consisted of: (i) $23.4 million related to proportional recognition of the $25 million milestone earned in Q1 2025 but payable following completion of the VERIFY clinical study report, and (ii) $10.5 million allocated to development services provided by us under the agreement during the period. Research and Development ("R&D") Expense: The increases in R&D expense from the prior year periods were primarily due to our clinical development and pre-clinical discovery programs, partially offset by decreases in rusfertide expenses related to the Phase 3 VERIFY clinical trial. We expect our research and development expenses to increase significantly in the second half of 2026 compared to the first half of 2026. The increase is expected to be driven primarily by the advancement of PN-881 into a comprehensive Phase 2 psoriasis program, planned investments in clinical manufacturing and CMC activities, including at-risk expenditures to ensure readiness for other programs as they advance into clinical development (PN-477sc, PN-458, PN-8047), additional pre-clinical discovery programs, as well as an increase in headcount and stock-based compensation expense. General and Administrative ("G&A") Expense: The increases in G&A expense from the prior year periods were primarily due to increases in stock-based compensation and other personnel-related expenses. Net Income (Loss): Net income was $162.8 million, or $2.47 per basic share and $2.29 per diluted share, for the second quarter of 2026 as compared to net loss of $34.8 million, or $0.55 per basic and diluted share, for the second quarter of 2025. Net income was $166.6 million, or $2.54 per basic share and $2.35 per diluted share, for the six months ended June 30, 2026 as compared to net loss of $46.4 million, or $0.73 per basic and diluted share, for the six months ended June 30, 2025. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE, launched in the U.S. in March 2026, is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment of polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. More information on Protagonist, its pipeline drug candidates and its 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 potential revenue from the Company's collaborations with Johnson & Johnson and Takeda, timing of regulatory actions and clinical trial completion, and advancement of the Company's discovery and clinical pipeline. 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 and royalty 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, 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 [email protected]+1 212 915 2577 Media Relations Contact Virginia AmannENTENTE Network of [email protected]+1 833 500 0061 ext 1 1 Additional information provided on slides 24 and 25 in the corporate deck posted to the corporate website as well as in the 8-K filed with the SEC on August 5, 2026 PROTAGONIST THERAPEUTICS, INC.Consolidated Statements of Operations(Amounts in thousands except share and per share data) (1) Amount includes non-cash stock-based compensation expense. Stock-based Compensation(In thousands) PROTAGONIST THERAPEUTICS, INC.Selected Consolidated Balance Sheet Data(In thousands) SOURCE: Protagonist Therapeutics, Inc. View the original press release on ACCESS Newswire

Alnylam Pharmaceuticals (ALNY) came out with quarterly earnings of $1.84 per share, missing the Zacks Consensus Estimate of $2.05 per share. This compares to earnings of $0.32 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -10.24%. A quarter ago, it was expected that this RNA interference drug developer would post earnings of $1.43 per share when it actually produced earnings of $1.99, delivering a surprise of +39.16%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Alnylam, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.29 billion for the quarter ended June 2026, missing the Zacks Consensus Estimate by 2.09%. This compares to year-ago revenues of $773.69 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Alnylam shares have lost about 27.9% since the beginning of the year versus the S&P 500's gain of 6.9%. While Alnylam has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Alnylam was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.22 on $1.47 billion in revenues for the coming quarter and $8.98 on $5.62 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Protagonist Therapeutics (PTGX), is yet to report results for the quarter ended June 2026. This biopharmaceutical company is expected to post quarterly earnings of $2.11 per share in its upcoming report, which represents a year-over-year change of +483.6%. The consensus EPS estimate for the quarter has been revised 12.6% higher over the last 30 days to the current level. Protagonist Therapeutics' revenues are expected to be $220.34 million, up 3870.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report Protagonist Therapeutics, Inc. (PTGX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

ICOTYDE™ (icotrokinra) approved by FDA in March for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment; Protagonist receives tiered royalties of 6% to 10% and is eligible for up to $580 million in future milestone payments Rusfertide NDA accepted and granted Priority Review by FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026 Protagonist exercised its rusfertide opt-out right under the Takeda collaboration on April 28, triggering a $200 million opt-out fee payable to the Company; eligible for additional $200 million opt-out and $75 million milestone payments upon NDA approval, sales milestones of up to $775 million and worldwide royalties ranging from 14% to 29% PN-881 (oral IL-17 antagonist peptide) Phase 1 study completion by mid-2026 and Phase 2 initiation anticipated by year-end; PN-477sc and PN-477o (sc and oral triple GLP/GIP/GICG agonist) Phase 1 initiation expected in mid-2026 and Q1 2027, respectively Cash, cash equivalents and marketable securities of $620 million as of March 31, 2026, anticipated to provide cash runway through at least 2028 NEWARK, CA / ACCESS Newswire / May 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. "The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide, and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477," said Dinesh V. Patel, Ph.D., the Company's President and Chief Executive Officer. "These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time." First Quarter 2026 Recent Developments and Upcoming Milestones Rusfertide On March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and granted Priority Review. The application is supported by data from the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term extension THRIVE study. The FDA set a PDUFA goal date in August 2026. On April 28, Protagonist announced that it exercised its right to opt out of the U.S. profit and loss sharing arrangement under the terms of its collaboration agreement with Takeda for rusfertide. The opt-out election triggers a $200 million payment to Protagonist, with an additional $200 opt-out fee and a separate $75 million milestone for FDA approval of rusfertide. The opt-out election also increases downstream economics payable to Protagonist, including up to $775 million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion. ICOTYDE™ (icotrokina) On March 18, Protagonist announced that Johnson & Johnson received U.S. Food and Drug Administration approval for ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The FDA approval triggered a $50 million milestone payment to Protagonist in the first quarter of 2026. Under the collaboration, Protagonist remains eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties ranging from 6% to 10% on global net sales with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier applying to the incremental annual sales above $4 billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasis On March 28, Protagonist announced presentation of new one-year Phase 3 ICOTYDE results at the 2026 American Academy of Dermatology Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further supported the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis, demonstrating durable efficacy and a favorable safety profile in a once-daily pill. Wholly-Owned Clinical and Discovery Programs PN-881 (oral IL-17 antagonist peptide): The Company expects completion of Phase 1 study by mid-2026 and initiation of a Phase 2 study by end of 2026. PN-477 (triple-G GLP/GIP/GCG agonist peptide): Phase 1 initiation of PN-477sc and PN-477o anticipated in mid-2026 and Q1 2027, respectively. PN-458 (dual GLP/GIP agonist peptide): IND-enabling studies in progress with PN-458sc and PN-458o PN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies in progress Discovery: Oral IL-4Rα antagonist and amylin oral mono/poly agonists are high-priority discovery programs. First Quarter 2026 Financial Results Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2026, were $620.3 million as compared to $646.0 million as of December 31, 2025. License and Collaboration Revenue: License and collaboration revenue of $56.4 million for the period ended March 31, 2026 consisted of (i) a $50.0 million milestone earned from JNJ in Q1 26 upon FDA approval of ICOTYDE, (ii) $3.3 million allocated to development services provided by us under the Takeda agreement during the period and (iii) $3.1 million cost reimbursement from Takeda for rusfertide clinical trial supplies. License and collaboration revenue of $28.3 million for the period ended March 31, 2025 consisted of (i) $22.8 million related to proportional recognition of a $25.0 million milestone earned in Q1 2025, and (ii) $5.5 million allocated to development services provided by us under the agreement during the period. Research and Development ("R&D") Expense: The increase in R&D expense from the prior year period was primarily due to increases related to our Phase 1 study for PN-881 and pre-clinical and drug discovery research expenses, including our obesity product candidates, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial. General and Administrative ("G&A") Expense: The increase in G&A expense from the prior year period was primarily due to an increase in personnel-related expenses, including wages and benefits and stock-based compensation. Income Tax Benefit: Income tax benefit was $1.5 million for the period ended March 31, 2026 and included a discrete credit for stock-based compensation expense specific to the current quarter. Net Income (Loss): Net income was $3.8 million, or $0.06 per basic share and $0.05 per diluted share, for the first quarter of 2026 as compared to net loss of $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026, is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. 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 potential revenue from the Company's collaborations with Johnson & Johnson and Takeda, timing of regulatory actions and clinical trial completion, and advancement of the Company's discovery and clinical pipeline. 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 and royalty 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, 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 [email protected] +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies [email protected] +1 833 500 0061 ext 1 PROTAGONIST THERAPEUTICS, INC. Consolidated Statements of Operations (Amounts in thousands except share and per share data) (1) Amount includes non-cash stock-based compensation expense. Stock-based Compensation (In thousands) PROTAGONIST THERAPEUTICS, INC. Selected Consolidated Balance Sheet Data (In thousands) SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire

(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.) NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expected by mid-2026 Pre-clinical pipeline expanded with novel wholly-owned candidates PN-477, an oral and s.c. triple GLP-GIP-GCG agonist and PN-458, an oral and s.c. dual GLP-GIP agonist, and PN-8047, an oral hepcidin functional mimetic Cash, cash equivalents and marketable securities of $646 million as of December 31, 2025, anticipated to provide cash runway through at least end of 2028 NEWARK, CA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update. "In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets." Fourth Quarter 2025 Recent Developments and Upcoming Milestones Rusfertide Under the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the second quarter of 2026. ICOTYDETM (Icotrokinra) A U.S. regulatory decision is anticipated in 2026, followed by commercial launch this year, if FDA approval is granted. Primary endpoint enrollment completion is expected in 2026 for: The Phase 3 ICONIC-ASCEND multicenter, randomized, double-blind, placebo-controlled, and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of icotrokinra for the treatment of participants with moderate to severe plaque psoriasis (NCT06934226). The Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of icotrokinra for the treatment of biologic-naïve participants with active psoriatic arthritis (NCT06878404). Clinical Programs The Company expects its Phase 1 study of PN-881 to be complete by mid-2026, informing subsequent clinical development plans. Discovery Programs Recently, Protagonist announced two new wholly owned development candidates: PN-458, a novel dual GLP-GIP agonist for obesity, and PN-8047, an oral hepcidin functional mimetic complementing rusfertide, an injectable hepcidin mimetic. Additionally, the Company added IL-4Rα and amylin as high-priority discovery programs to further expand and strengthen its pipeline. Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of December 31, 2025, were $646.0 million as compared to $559.2 million in the previous year. Revenue: License and collaboration revenue is derived from the Company's License and Collaboration Agreement with JNJ, (the "JNJ Agreement"), and its License and Collaboration Agreement with Takeda (the "Takeda Agreement"). License and collaboration revenue decreased by $163.2 million from $170.6 million for the fourth quarter of 2024 to $7.4 million for the fourth quarter of 2025. License and collaboration revenue decreased by $388.4 million from $434.4 million for the full year 2024 to $46.0 million for the full year 2025. The decrease in revenue was primarily attributable to lower milestone and collaboration revenue, which is highly variable and dependent upon factors such as the timing of when regulatory and sales milestones are achieved, if at all, and the accounting for any upfront payments associated with any existing or new agreements. License and collaboration revenue of $7.4 million for the fourth quarter of 2025 was comprised of development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $170.6 million for the fourth quarter of 2024 included (i) achievement of a non-refundable $165.0 milestone under the JNJ Agreement, and (ii) development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $46.0 million for the full year 2025 was comprised of (i) proportional recognition of a $25.0 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period under the Takeda agreement. License and collaboration revenue of $434.4 million for the full year 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda Agreement allocated to the rusfertide license upon effectiveness of the agreement, (ii) achievement of a non-refundable $165.0 milestone under the JNJ Agreement earned in Q4 24, and (iii) development services we provided during the period under the Takeda Agreement. Research and Development Expenses: Increased by $11.5 million and $21.2 million for the fourth quarter and full year 2025, respectively, from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses, including expenses related to our IL-17 product candidate PN-881 and our obesity product candidates. General and Administrative Expenses: Increased by $2.5 million for the three months ended December 31, 2025, from the prior year period primarily due to increases in professional services and personnel-related expenses. The increase of $1.4 million for the full year 2025 as compared to the prior year was primarily due to increases in professional services and personnel-related expenses, partially offset by $4.6 million in one-time advisory and legal fees in 2024 related to the Takeda Agreement. Net (Loss) Income: Net loss was $44.4 million, or $0.69 per basic share and diluted share, for the fourth quarter of 2025 as compared to net income of $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024. Net loss was $130.1 million, or $2.05 per basic share and diluted share, for the full year 2025, as compared to net income of $275.2 million, or $4.47 per basic share and $4.23 per diluted share, for the full year 2024. 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 a New Drug Application (NDA) for ICOTYDETM (icotrokinra) under review at the FDA and an NDA for rusfertide submitted in December 2025. ICOTYDE is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following ICOTYDE's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of ICOTYDE through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in development for the rare blood disorder polycythemia vera. Rusfertide is being co-developed and may be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement under which the Company was primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. 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 potential timing of regulatory actions, clinical trial results, and potential revenue from the Company's collaborations with Takeda and Johnson & Johnson. 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 [email protected] +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies [email protected] +1 833 500 0061 ext 1 PROTAGONIST THERAPEUTICS, INC. Consolidated Statements of Operations (Amounts in thousands except share and per share data) (1) Amount includes non-cash stock-based compensation expense. Stock-based Compensation (In thousands) PROTAGONIST THERAPEUTICS, INC. Selected Consolidated Balance Sheet Data (In thousands) SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire

NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with  potential launch this year PN-881 Phase 1 completion expected by mid-2026 NEWARK, CALIFORNIA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update. "In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets." Fourth Quarter 2025 Recent Developments and Upcoming Milestones Rusfertide Under the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the second quarter of 2026. ICOTYDETM (Icotrokinra) A U.S. regulatory decision is anticipated in 2026, followed by commercial launch this year, if FDA approval is granted. Primary endpoint enrollment completion is expected in 2026 for: The Phase 3 ICONIC-ASCEND multicenter, randomized, double-blind, placebo-controlled, and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of icotrokinra for the treatment of participants with moderate to severe plaque psoriasis (NCT06934226). The Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of icotrokinra for the treatment of biologic-naïve participants with active psoriatic arthritis (NCT06878404). Clinical Programs The Company expects its Phase 1 study of PN-881 to be complete by mid-2026, informing subsequent clinical development plans. Discovery Programs Recently, Protagonist announced two new wholly owned development candidates: PN-458, a novel dual GLP-GIP agonist for obesity, and PN-8047, an oral hepcidin functional mimetic complementing rusfertide, an injectable hepcidin mimetic. Additionally, the Company added IL-4Rα and amylin as high-priority discovery programs to further expand and strengthen its pipeline. Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of December 31, 2025, were $646.0 million as compared to $559.2 million in the previous year. Revenue: License and collaboration revenue is derived from the Company's License and Collaboration Agreement with JNJ, (the "JNJ Agreement"), and its License and Collaboration Agreement with Takeda (the "Takeda Agreement"). License and collaboration revenue decreased by $163.2 million from $170.6 million for the fourth quarter of 2024 to $7.4 million for the fourth quarter of 2025. License and collaboration revenue decreased by $388.4 million from $434.4 million for the full year 2024 to $46.0 million for the full year 2025. The decrease in revenue was primarily attributable to lower milestone and collaboration revenue, which is highly variable and dependent upon factors such as the timing of when regulatory and sales milestones are achieved, if at all, and the accounting for any upfront payments associated with any existing or new agreements. License and collaboration revenue of $7.4 million for the fourth quarter of 2025 was comprised of development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $170.6 million for the fourth quarter of 2024 included (i) achievement of a non-refundable $165.0 milestone under the JNJ Agreement, and (ii) development services we provided during the period under the Takeda Agreement. License and collaboration revenue of $46.0 million for the full year 2025 was comprised of (i) proportional recognition of a $25.0 million milestone earned from Takeda in Q1 25, and (ii) development services we provided during the period under the Takeda agreement. License and collaboration revenue of $434.4 million for the full year 2024 included (i) $254.1 million of the $300.0 million initial transaction price for the Takeda Agreement allocated to the rusfertide license upon effectiveness of the agreement, (ii) achievement of a non-refundable $165.0 milestone under the JNJ Agreement earned in Q4 24, and (iii) development services we provided during the period under the Takeda Agreement. Research and Development Expenses: Increased by $11.5 million and $21.2 million for the fourth quarter and full year 2025, respectively, from the prior year periods. The increases were due primarily to increases in drug discovery and pre-clinical research expenses, including expenses related to our IL-17 product candidate PN-881 and our obesity product candidates. General and Administrative Expenses: Increased by $2.5 million for the three months ended December 31, 2025, from the prior year period primarily due to increases in professional services and personnel-related expenses. The increase of $1.4 million for the full year 2025 as compared to the prior year was primarily due to increases in professional services and personnel-related expenses, partially offset by $4.6 million in one-time advisory and legal fees in 2024 related to the Takeda Agreement. Net (Loss) Income: Net loss was $44.4 million, or $0.69 per basic share and diluted share, for the fourth quarter of 2025 as compared to net income of $131.7 million, or $2.11 per basic share and $1.98 per diluted share, for the fourth quarter of 2024. Net loss was $130.1 million, or $2.05 per basic share and diluted share, for the full year 2025, as compared to net income of $275.2 million, or $4.47 per basic share and $4.23 per diluted share, for the full year 2024. 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 a New Drug Application (NDA) for ICOTYDETM (icotrokinra) under review at the FDA and an NDA for rusfertide submitted in December 2025. ICOTYDE is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R"), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following ICOTYDE's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of ICOTYDE through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in development for the rare blood disorder polycythemia vera. Rusfertide is being co-developed and may be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement under which the Company was primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. 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 potential timing of regulatory actions, clinical trial results, and potential revenue from the Company's collaborations with Takeda and Johnson & Johnson. 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 [email protected] +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies [email protected] +1 833 500 0061 ext 1 PROTAGONIST THERAPEUTICS, INC. Consolidated Statements of Operations (Amounts in thousands except share and per share data) (1) Amount includes non-cash stock-based compensation expense. Stock-based Compensation (In thousands) PROTAGONIST THERAPEUTICS, INC. Selected Consolidated Balance Sheet Data (In thousands) SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire

Image source: The Motley Fool. Wednesday, March 10, 2021 at 10:12 p.m. ET Chief Executive Officer — Dinesh Patel Chief Medical Officer — Samuel Saks Chief Scientific Officer — David Liu Chief Development Officer — Suneel Gupta Chief Financial Officer — Don Kalkofen Need a quote from a Motley Fool analyst? Email [email protected] Dinesh Patel: Thank you, Tom. Good afternoon, everyone and thank you all for joining our conference call to discuss Protagonist Therapeutics’ financial results and corporate highlights for the fourth quarter and full year 2020. Don and I are joined on today’s call by Samuel Saks, our Chief Medical Officer; David Liu, our Chief Scientific Officer; and Suneel Gupta, Chief Development Officer. 2020 was an exceptional and transformative year for Protagonist during which we expanded our clinical pipeline and we now have five different new chemical entities or NCEs that are being advanced in six different clinical studies. And all of these studies are expected to be completed over the next 2 years. As many of you know, each of our clinical assets has been developed through our proprietary technology platform. And currently, we are developing novel therapeutic options across three distinct disease categories: one, various blood disorders influenced by excessive red blood cell production that is accessing erythrocytosis or by excessive iron overload conditions; two, inflammatory bowel disease, or IBD, such as Crohn’s disease and ulcerative colitis; and three, various inflammatory and autoimmune diseases that have already been clinically validated by the interleukin-23 or IL-23 pathway. I would like to start today’s call by reviewing rusfertide previously known as PTG-300. As a reminder, rusfertide is a peptide mimetic of the natural hormone hepcidin, which is a key regulator of iron homeostasis, as it controls the absorption, storage and distribution of iron in the body. Rusfertide was developed to have superior drug like properties, including its potency, half-life solubility, stability and ease of synthesis in comparison to the natural hormone. Our most advanced clinical program with this candidate is in patients with polycythemia vera, also known as PV, a rare and progressive blood disorder affecting about 160,000 patients in the United States alone. In May of 2020, we presented a very small, but robust dataset for 7 patients from our ongoing Phase 2 PV trial and that proved to be a turning point for Protagonist. In December last year, in an oral presentation at the ASH Conference, we shared the data for 18 patients from the same study and we are pleased to see the continuation of the robust clinical responses observed earlier in May. To quickly recap the data, rusfertide appears to be safe, well-tolerated and very effective in managing hematocrit control below 45% across the 18 adult patients evaluated. This tight hematocrit control also led to a dramatic decrease in the need for therapeutic phlebotomy, the most common treatment modality for this condition. Furthermore, we also observed a reversal of iron deficiency in these patients. Iron deficiency is a typical undesired outcome of therapeutic phlebotomy in these patients. While phlebotomy is the current mainstay of PV treatment, many patients are unable to maintain hematocrit levels below 45% as per the NCCN guidelines and this is unfortunately true even for those patients receiving frequent phlebotomies and receiving treatment with cytoreductive agents. Don Kalkofen: Thank you, Dinesh. Once again, thank you all for joining us this afternoon. Today, we issued our earnings release for year end 2020 and are filing our 10-K, where you could find further details on our most recent financials. On the call today, I would like to review some of the key financial highlights for 2020. Starting with our revenue, we reported license and collaboration revenue for the full year of 2020 of $28.6 million as compared to $0.2 million for the full year of 2019. As you may recall, last year, the company’s 2019 revenue was offset by a one-time cumulative adjustment related to the application of revenue recognition principles, following the amendment of the Janssen Biotech agreement in May of ‘19. This had reduced the 2019 revenue recognition by $9.4 million. The 2020 revenue increase over prior year was also related to recognition of revenue from providing preclinical and clinical development activities under the collaboration agreement with Janssen for both new assets, PN-235 and PN-232 as well as an update to the forecast of the remaining services to be delivered under the collaboration. License and collaboration revenue for the fourth quarter of 2020 was $5.7 million compared to $2.7 million for the same period of 2019. Dinesh Patel: Thank you, Don. We are very pleased with our progress to-date and we look forward to continue our strong momentum as we move through 2021. We thank our shareholders for their support and the confidence in our work. We thank the investigators who advance our clinical studies and the patients who participate in these studies. Finally, I want to personally thank the Protagonist team. I mean, the challenges that 2020 imposed on the world at large, our employees not only state the course, but instead excel in several functions. Their unwavering focus and dedication is what has made the progress possible that we are describing today. Collectively, as a team, we look forward to even more exciting progress in the months and years ahead. Operator: Thank you. Your first question comes from the line of Yasmeen Rahimi with Piper Sandler. Unidentified Analyst: Hi, team. This is Rachel on for Yasmeen. Thanks very much for taking our questions. So, our first question is can you help us understand how the regulatory pathway could differ between development in low risk versus high risk PV patients who fail on current treatment options? In other words, can you help understand what part of the Phase 3 design is set in stone and which factors remain to be discussed? Thank you. Dinesh Patel: Well, that’s a very important question and distinction and I would have our CMO, Sam, take a crack at it. Samuel Saks: Yes. I would just say that we can’t obviously at this point, articulate definitive guidance on the FDA design. But I can tell you that our Phase 2 study is open to patients, whether they are onsite or reductive or not. And the common theme is patients who require too many phlebotomies. So, while patients are divided into high and low risk categories, patients are divided into those who are receiving cytoreductive agents like hydroxyurea, interferon and those that aren’t. The commonality between all the patients is that they are receiving frequent phlebotomy. I will also ask Suneel Gupta, if he wants to say anything else about the clinical design. Suneel Gupta: I think you have covered all the important aspects. I think there is nothing. Dinesh Patel: Yes. I think the short answer is from the Phase 2 study, it seems the drug is very effective in both populations. So, obviously, we want to have as broad a utility as possible. Our theme is basically this is a drug for choice where the current therapy is ineffective. Unidentified Analyst: Thank you. That’s very helpful. And as a follow-up, based on your discussions with the FDA, do you believe that the FDA and the EMA view the regulatory pathway in PV through the same lens? Thank you. Dinesh Patel: Well, the unknowns are the unknowns. And I think we sound like a broken record that I think it’s still the most meaningful statement. The dialogue is ongoing. And when we have clarity, we will share it with everybody, the whole world and we believe that should happen in the first half of this year. Samuel Saks: Of course, the only historical comparison one could make, we can’t talk about again our own discussions. But the only historical comparison one could make would be to Jakafi, which was registered in both the EU and the U.S. And shortly, you may have a comparison of oral peg-interferon, which is available in Europe and is on file in the U.S., not that those are directly relevant to us, but those are the historical comparisons. Unidentified Analyst: Great. Thanks. That’s very helpful. And as our last question, can you tell us what other indications beyond PV and HH for which rusfertide will make mechanism for? Thank you. Samuel Saks: Yes. We have been thinking about two general areas, not to get specific here, but just generally and they are kind of self-evident if you think about it, based on the results with PV. One is diseases that are treated with phlebotomy and the other is diseases that are – one of the hallmarks of the disease is erythrocytosis. So obviously, in PV, those patients have erythrocytosis of a particular type and they need phlebotomy. So we are trying to think about both of those as avenues for further development and other indications and there are multiple diseases in each of those categories. Dinesh Patel: Yes. So, the triangulation of phlebotomy is a therapy, iron overload and excessive erythrocytosis. Unidentified Analyst: Thanks very much for taking our questions. Dinesh Patel: Sure. Thanks. Operator: Your next question comes from the line of Chris Howerton with Jefferies. Chris Howerton: Great. Thanks so much for taking the questions and obviously, congratulations on all the progress across the board. So, maybe as a first question, just as a follow-up to some of that questioning with respect to PV and the regulatory path, if we could focus on the primary endpoint here like what are kind of the key features that you need to come to alignment on with the FDA with respect to the primary endpoint? Is it the specific endpoint that you want to go after? Is it the duration on therapy and follow-up? And I guess, what is your initial view in terms of what are the kind of categories that one needs to satisfy to get a registrational study completed? Dinesh Patel: Yes. So, I will make a general statement and then Sam will chime in. But the current data we have from the ongoing Phase 2 study leads us to believe and it’s self evident that they have amazing hematocrit control and joined to the hip, but that observation is a drastic reduction in the phlebotomy requirement and that has been sort of the cornerstone in this disease indication. So we are good with whatever the final outcome would be. But Sam? Samuel Saks: Yes. I mean, this is a chronic disease. And so we believe that we’ll need data over a reasonable period of time. And as Dinesh said, the hallmark is keeping the hematocrit below 45. That’s what’s in every guideline. That’s what is in every medical textbook. And so 24/7 keeping it before, keeping it under 45 over a significant period of time will be an important aspect of the primary endpoint. How it’s defined? How it’s analyzed? What else could be in there? We’re not ready to say that. But again, from historical present and just from what we know about the disease, it’s clear to us that the backbone of the primary endpoint will involve keeping the Hematocrit below 45. Chris Howerton: Okay, alright. That’s very clear. Thank you. And maybe as a second question, if we can maybe shift our focus to PN-943 or the IBD, I think, obviously, there is been recognition and focus of early-stage receptor occupancy data. And I think one of the questions that I’ve received numerous times from investors is, how does this mechanism work from a systemic versus a local or gut-restricted activity? And kind of how does that work? It seems like there is some confusion out there. So it might be helpful if you could compare and contrast local delivery in a gut-restricted manner versus systemic and kind of what you see in terms of the relevance of reset occupancy data? Thank you. Dinesh Patel: Thanks, Chris. That’s a very important question. It is also one of the most common questions we are receiving in recent days. And I’ll give some general answer to it. And then our CFO, David Liu, will chime in with some more details. The way we look at alpha-4-beta-7 integrin is – obviously, it’s a validated target. It’s one of the most safe and IBD specific target as established by TVO from Takeda. Now there are two types of approaches over here. One is where diction is through systemic exposure. And over there, we have the injectable antibody drugs and orally bioavailable small molecule drugs, the other approach, which Protagonist has undertaken, and in fact Protagonist is the only company in that space is the gut-restricted approach. So now the main action is not in the blood compartment, but rather tackling the target in the GI tissue compartment. So while we are the only presence over here, then the question is, is that a risky proposition, the answer, in our opinion, is no, because, as you know, with our previous first generation drug PTG-100, the already established clinical proof-of-concept in a Phase 2a study in ulcerative – in moderate-to-severe disease ulcerative colitis patients, where we got clinical remission rates of 16%, similar to TVO in a Phase 2a study, and from the biopsy samples, colonic biopsy samples of these patients, we got 44% histologic remission. So yes, ours is a unique approach. And – but we already have the clinical proof-of-concept from the first generation drug. And now we are moving forward with the second-generation drug 943, which is at least threefold more potent by all in vitro, in vivo preclinical and even Phase 1, the receptor occupancy measurements that we have conducted so far between these two drugs. The blood receptor occupancy component, this is where David, you may want to chime in and take over the conversation. David Liu: Yes. Thank you, Dinesh. So I think everything that Dinesh mentioned that has been observed for the benefit of our approach in the clinic was presaged by all of the work that we did preclinically. So looking at trafficking, looking at pharmacodynamic responses that were associated with the trafficking with disease outcomes in as well as histological outcomes in preclinical models of colitis, and that was all basically predictive of what we eventually observed in the clinic. With regard to the pharmacodynamic responses, as shown predominantly by receptor occupancy in the blood, we believe that the surrogate of essentially what was initially target high target engagement it locally on the immune cells and residing in the gut. And as those cells are trafficking back out, they can’t reenter because of the very tightly bound 943 to the surface of that cells on the integrins. In addition, we think the high local target engagement engenders a very nice effect on cells that are trying to proliferate and be activated from alpha-4-beta-7 engagement as a co-stimulatory factor. And we can – we have shown that from in vitro studies that we can certainly block that mechanism, so high local target engagement, blocking both trafficking and local activation of the T-cells. Dinesh Patel: And what I would add, Chris, is that for our gut-restricted approach, we have established, based on our clinical POC data, the efficacious dose in the ulcerative colitis study, that translated to 74% blood receptor occupancy in Phase 1 study in healthy humans. So that is our guideline for the gut-restricted integrin blocker approach. And in a Phase 1 study of 943, we know that we can surpass that 74% number easily at 3x lower doses versus the previous drug. Now for the systemic drugs, 100% RO, blood RO is a goalpost, but we know and we don’t have to get into the details, but the minimal dose at which one can achieve 100% RO is significantly lower than the actual efficacy of dose that have been used for the systemic drugs. Chris Howerton: Great. Okay. Well, thank you very much for that color and I appreciate the perspective and thanks. Operator: Your next question comes from the line of Joseph Schwartz with SVB Leerink. Unidentified Analyst: This is on for Joe. Maybe one about indications outside of IBD for your oral IL-23 antagonist, how are you approaching or maybe thinking about the bioavailability differences that might be needed for more systemic indications versus those that are more gut-restricted? And are there any attributes of your new agents, PN-235 or 232 that you designed in or selected for that might lend themselves to a more gut-restricted or more systemic profile? Thanks. Dinesh Patel: That’s an excellent question, Kelly, really appreciate it. And as you know, we are a peptic technology platform company, and we like to be the pioneers in the advancement of the field of peptidic science. So initially, we went on the journey of discovering peptides that were as potent as antibodies. The next step was that making peptides that are orally stable and gut-restricted. And maybe the ultimate Holy Grail in the field of peptides would be where we could make peptides orally available. So for the IL-23 program in general, our future undertakings, we would not be shying away from targets or approaches that actually require some sort of systemic oral bioavailability. That’s how I would frame it. Unidentified Analyst: Great. Excellent. And thanks for taking our questions. Operator: Your next question comes from the line of Anupam Rama with JPMorgan. Anupam Rama: Hey, guys. Thanks so much for taking the question. Just two quick ones for me. First is more of a clarification question on PTG-300 Phase 2. At the conference and then in your press release today, you talked about updates at medical conferences in 2021. So is this a EHA and ASH strategy or and sort of ASH-only type of strategy post enrollment completion midyear? That’s our first question. Second one is one of the questions we’ve been getting a little bit on PTG-300 is in PV – based on the profile that’s emerging post ASH, where does this drug fit in the treatment paradigm based on your market research? Thanks so much. Dinesh Patel: Sure. Let me – I’m sure Sam will want to elaborate. But very quickly, no, we aren’t going to just wait until the end of the year to present things at the ASH conference. There are significant conferences in mid-year and throughout the year. So it is our full intention to present updates at medical conferences throughout the year. Samuel Saks: Yes. Remember, the first part of the study is an open-label Phase 2 study. So since it’s open-label we have no problem with reporting on it and being transparent over time. The second part, which is randomized and blinded, that would require the last person completing the study before we could update that part of the study. With respect to where we see this being used, as we kind of said earlier, we’re not trying to replace any particular therapy. We think that people who have too many phlebotomies have been demonstrated to have two things: One is too much time spent above 45. And we think that’s guideline for reason medically in terms of preventing events. So we think that’s not a good thing to be spending time above 45. And of course, the people have many phlebotomies are the ones who have the highest degree of iron deficiency because obviously, the more phlebotomies you’re doing, the more iron you’re taking out of the body on a regular basis. And those are the patients where we would expect to see if we see a sentiment improvement, obviously, that’s where we would expect to see it the most is in the people who have the highest degree of iron deficiency. So again, it’s not a strategy of saying, don’t use any particular other therapy. If you and your doctor decide any other therapy is useful and important for you that’s great, but what we see in the marketplace is with the existing therapeutics are available, that there are many patients who are on other drugs now too many phlebotomy or on phlebotomy alone and have too many phlebotomy, and those are our patients. Dinesh Patel: Yes. So Anupam, the way I would phrase it is that essentially, this is a drug – this could be a drug of choice when the current therapy is ineffective. And our Symphony data server basically shows that majority of patients will fall in this category. And if you look at our current Phase 2 study, the data we presented at ASH on 18 patients, it’s like 8 patients are on phlebotomy alone, then 7 patients are on hydroxyurea. We also have 3 patients that are in interferon. And remember, the qualification for getting into our study is in spite of those treatments, they require frequent phlebotomies, at least 3 or more phlebotomies in a 6-month period. So that translates to more than 6 phlebotomies annually and it demonstrates two things. It’s like the current treatments are uneffect. And too many frequent phlebotomies are not a good thing for the patients ultimately. And that is where we would like to see the performance of our drug. Samuel Saks: Yes. We presented our Symphony data at ASH. It’s in a poster and ASH that was presented by one of the key opinion leaders and the punch line is where they use cytoreductive or use phlebotomy alone. Many patients are not receiving treatment according to the treatment guidelines. Anupam Rama: Understood. Thank you so much for taking my questions. Dinesh Patel: Absolutely. Operator: Your next question comes from the line of Douglas Tsao with H.C. Wainwright. And you are live. Dinesh Patel: Hey, Doug. Douglas Tsao: Hey, guys. I am having a little trouble with my line. So, just in terms of the new IL-23 that has been nominated by Janssen for development. Just curious, at what point should we start to get a sense of what indications that you are thinking about? And obviously, I would presume the horizons might be a little broader than just in IBD just given how – as you alluded to earlier, right, it might not just be sort of got restricted. Obviously, Stelara has pretty wide use. Dinesh Patel: Yes. Doug, it’s an excellent question. And as you can imagine, over here, this is a partnership with Janssen. So we have to be mindful of the statements we make. But I would just like to phrase it this way. Our collaboration with Janssen is not on IBD. Our collaboration Janssen is on IL-23 receptor antagonist. So wherever the IL-23 pathway, intervention of the IL-23 pathway lids to a medical utility in a particular disease indication, that is where we are theoretically going with the multiple optionalities. And so the idea is like hey, let’s add a few promising candidates in the development bucket, we have at least three as of now. And then the various strategic and clinical options will become more clear down the road as we get more data from the current Phase 1 and Phase 2 studies that we are conducting with these candidates. Douglas Tsao: And Dinesh, you just sort of went on. So I guess it sounds like what we learn from the Phase 1 in terms of bioavailability, PK profile, etcetera real sort of help determine which of those indications, especially outside of IBD might – which the candidate might be best suited for? Dinesh Patel: Yes, it will be hard to disagree with your logic. Douglas Tsao: Okay, thank you so much. Dinesh Patel: Thanks, Doug. Operator: And with that, this concludes our Q&A section. And I would like to hand it over to Dinesh Patel for closing remarks. Dinesh Patel: Thank you again everybody for joining us this afternoon. And this formally concludes our fourth quarter 2020 and full year 2020 conference call and webcast. Thank you. Operator: This concludes today’s conference call and you may now disconnect. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. If you’re worried you’ve already missed your chance to invest, now is the best time to buy before it’s too late. 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