Protagonist Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Protagonist Therapeutics (PTGX) reported Q3 2024 financial results with key upcoming milestones. The company expects top-line results for JNJ-2113 Phase 3 trials in psoriasis in Q4 2024, Phase 2b in ulcerative colitis in Q1 2025, and rusfertide Phase 3 in polycythemia vera in Q1 2025. Financial highlights include cash position of $583.3 million, expected to last through 2027. Q3 2024 showed revenue of $4.7 million, R&D expenses of $36 million, and net loss of $33.2 million ($0.54 per share). The company recognized $263.8 million in revenue for the nine months ended September 30, 2024, largely from the Takeda collaboration agreement.
Protagonist Therapeutics (PTGX) ha riportato i risultati finanziari del terzo trimestre del 2024, evidenziando importanti traguardi futuri. L'azienda prevede i risultati preliminari per i trial di JNJ-2113 Fase 3 nella psoriasi nel quarto trimestre del 2024, la Fase 2b nella colite ulcerosa nel primo trimestre del 2025 e rusfertide Fase 3 nella policitemia vera nel primo trimestre del 2025. I punti salienti finanziari includono una posizione di liquidità di 583,3 milioni di dollari, prevista per durare fino al 2027. Il terzo trimestre del 2024 ha mostrato entrate di 4,7 milioni di dollari, spese per R&D di 36 milioni di dollari e una perdita netta di 33,2 milioni di dollari (0,54 dollari per azione). L'azienda ha riconosciuto 263,8 milioni di dollari di entrate per i nove mesi terminati il 30 settembre 2024, provenienti principalmente dall'accordo di collaborazione con Takeda.
Protagonist Therapeutics (PTGX) informó sobre los resultados financieros del tercer trimestre de 2024 con hitos importantes por delante. La compañía espera resultados preliminares de los ensayos de JNJ-2113 Fase 3 en psoriasis en el cuarto trimestre de 2024, la Fase 2b en colitis ulcerosa en el primer trimestre de 2025 y rusfertide Fase 3 en policitemia vera en el primer trimestre de 2025. Los puntos destacados financieros incluyen una posición de efectivo de 583,3 millones de dólares, que se espera que dure hasta 2027. El tercer trimestre de 2024 mostró ingresos de 4,7 millones de dólares, gastos en I+D de 36 millones de dólares y una pérdida neta de 33,2 millones de dólares (0,54 dólares por acción). La compañía reconoció 263,8 millones de dólares en ingresos durante los nueve meses que terminaron el 30 de septiembre de 2024, principalmente por el acuerdo de colaboración con Takeda.
Protagonist Therapeutics (PTGX)는 2024년 3분기 재무 결과를 발표하며 주요 향후 이정표를 공유했습니다. 이 회사는 JNJ-2113 3상 시험의 건선 결과를 2024년 4분기에, rusfertide 3상 시험의 적혈구증가증을 2025년 1분기에, 그리고 대장염 2b상을 2025년 1분기에 발표할 것으로 기대하고 있습니다. 재무 하이라이트로는 5억 8,330만 달러의 현금 보유가 있으며, 이는 2027년까지 지속될 것으로 예상됩니다. 2024년 3분기에는 470만 달러의 수익, 3,600만 달러의 R&D 비용 및 3,320만 달러의 순손실(주당 0.54달러)이 발생했습니다. 이 회사는 2024년 9월 30일로 종료된 9개월 동안 2억 6,380만 달러의 수익을 인식했으며, 주로 다케다와의 협력 계약에서 발생했습니다.
Protagonist Therapeutics (PTGX) a publié les résultats financiers du troisième trimestre 2024, en mettant en avant des jalons importants à venir. L'entreprise prévoit des résultats préliminaires pour les essais JNJ-2113 Phase 3 dans le psoriasis au quatrième trimestre 2024, la Phase 2b dans la colite ulcéreuse au premier trimestre 2025, et rusfertide Phase 3 dans la polycythémie vera au premier trimestre 2025. Les points saillants financiers comprennent une position de trésorerie de 583,3 millions de dollars, prévue pour durer jusqu'en 2027. Le troisième trimestre 2024 a montré des revenus de 4,7 millions de dollars, des dépenses de R&D de 36 millions de dollars, et une perte nette de 33,2 millions de dollars (0,54 dollar par action). L'entreprise a reconnu 263,8 millions de dollars de revenus pour les neuf mois se terminant le 30 septembre 2024, provenant principalement de l'accord de collaboration avec Takeda.
Protagonist Therapeutics (PTGX) hat die finanziellen Ergebnisse für das 3. Quartal 2024 veröffentlicht und wichtige bevorstehende Meilensteine hervorgehoben. Das Unternehmen erwartet die vorläufigen Ergebnisse der JNJ-2113 Phase 3 Studien bei Psoriasis im 4. Quartal 2024, Phase 2b bei Colitis ulcerosa im 1. Quartal 2025 und rusfertide Phase 3 bei Polycythaemia vera im 1. Quartal 2025. Zu den finanziellen Höhepunkten gehört eine Liquiditätsposition von 583,3 Millionen US-Dollar, die voraussichtlich bis 2027 ausreichen wird. Im 3. Quartal 2024 wurden Einnahmen von 4,7 Millionen US-Dollar, F&E-Ausgaben von 36 Millionen US-Dollar und ein Nettoverlust von 33,2 Millionen US-Dollar (0,54 US-Dollar pro Aktie) verzeichnet. Das Unternehmen erkannte für die neun Monate bis zum 30. September 2024 Einkünfte von 263,8 Millionen US-Dollar, hauptsächlich aus der Zusammenarbeit mit Takeda.
- Strong cash position of $583.3 million, providing runway through 2027
- Significant revenue recognition of $263.8 million for nine months ended September 30, 2024
- Strategic Takeda collaboration agreement with $300 million upfront payment
- Increased R&D expenses by $5.3 million compared to prior year quarter
- Higher G&A expenses, up $2.5 million from prior year quarter
- Quarterly net loss of $33.2 million
Insights
This earnings report reveals significant financial developments for Protagonist. The company maintains a robust cash position of
R&D expenses increased by
The clinical pipeline shows remarkable progress with multiple late-stage programs approaching critical readouts. The Phase 3 trials for JNJ-2113 in psoriasis (ICONIC-LEAD and ICONIC-TOTAL) and rusfertide in polycythemia vera represent significant near-term opportunities. The expansion into ulcerative colitis with JNJ-2113's Phase 2b study demonstrates pipeline diversification.
The company's development of an oral IL-17 peptide antagonist could be particularly significant, as current IL-17 inhibitors are injectable. The strategic focus on validated biological targets in hematology, inflammation and obesity suggests a well-thought-out pipeline strategy with multiple shots on goal.
Top line results for JNJ-2113 Phase 3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in patients with moderate to severe psoriasis expected in Q4 2024
Top line results for JNJ-2113 Phase 2b ANTHEM clinical trial in moderate to severe ulcerative colitis expected in Q1 2025
Top line results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera expected in Q1 2025
Development candidate nomination for oral IL-17 peptide antagonist expected in Q4 2024
Cash, cash equivalents and marketable securities of
NEWARK, CA / ACCESSWIRE / November 7, 2024 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.
"Protagonist is approaching multiple transformational events with the pending readouts of JNJ-2113 in Phase 3 psoriasis studies this year, Phase 2b ulcerative colitis study in Q1 2025, and rusfertide Phase 3 study in polycythemia vera in Q1 2025," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "In addition, we look forward to unveiling more details on an IL-17 oral peptide antagonist development candidate later this year, as well as other development candidates from our hematology and obesity programs in 2025. Our strong cash position affords us the flexibility to progress them independently into pre-clinical and clinical development over the coming years."
Upcoming Milestones
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV)
The top line data for the Phase 3 VERIFY study1 in polycythemia vera, which has a 32-week primary efficacy endpoint, is expected in Q1 2025.
JNJ-2113: Oral IL-23 Receptor Antagonist
Top line results for the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies2 in moderate to severe plaque psoriasis, are expected in Q4 2024.
Top line results for the Phase 2b ANTHEM multicenter, randomized, placebo- controlled, dose-ranging study of JNJ-2113 for the treatment of moderately to severely active ulcerative colitis3, is expected in Q1 2025.
Top line results for the Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 superiority studies4, evaluating the safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib in moderate to severe plaque psoriasis, is expected in Q2 2025.
Top line results for the Phase 3 in pustular and erythrodermic psoriasis5 evaluating the safety and efficacy of JNJ-2113 in approximately 16 subjects compared with placebo, is expected in Q2 2025.
Discovery Programs
Protagonist is pursuing the discovery of novel and potent oral peptides against various clinically and commercially validated biological targets in hematology, inflammation and immunomodulatory diseases, and obesity.
The Company expects to nominate a development candidate from its oral IL-17 peptide antagonist program in Q4 2024.
Protagonist is also anticipating the nomination of an oral development candidate in the hepcidin mechanism-based hematology program in Q1 2025, and an oral peptide-based development candidate in the obesity program by the middle of 2025.
__________________________________
1 VERIFY (NCT05210790)
2 ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
3 ANTHEM (NCT06049017)
4 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
5 Pustular/Erythrodermic (NCT06295692)
Third Quarter 2024 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2024, were
$583.3 million as compared to$341.6 million as of December 31, 2023.
| Three Months Ended |
|
| Nine Months Ended |
| |||||||||||
| September 30, |
|
| September 30, |
| |||||||||||
(in thousands, except per share amounts) |
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| ||||
| (Unaudited) |
| ||||||||||||||
License and collaboration revenue |
| $ | 4,675 |
|
| $ | - |
|
| $ | 263,795 |
|
| $ | - |
|
Research and development expense |
| $ | 35,970 |
|
| $ | 30,664 |
|
| $ | 103,224 |
|
| $ | 91,262 |
|
General and administrative expense |
| $ | 10,158 |
|
| $ | 7,662 |
|
| $ | 34,508 |
|
| $ | 25,439 |
|
Net income (loss) |
| $ | (33,210 | ) |
| $ | (34,105 | ) |
| $ | 143,514 |
|
| $ | (106,290 | ) |
Basic earnings (loss) per share |
| $ | (0.54) |
|
| $ | (0.58) |
|
| $ | 2.34 |
|
| $ | (1.91) |
|
Diluted earnings (loss) per share |
| $ | (0.54) |
|
| $ | (0.58) |
|
| $ | 2.22 |
|
| $ | (1.91) |
|
License and Collaboration Revenue: The Takeda Collaboration Agreement included a one-time nonrefundable upfront payment of
$300.0 million , of which we recognized$255.0 million during the first quarter of 2024. The remaining$45.0 million was recorded as deferred revenue to be recognized over time as the Company satisfies its performance obligation to complete the ongoing Phase 3 VERIFY trial for rusfertide.During the third quarter of 2024, we recognized
$4.7 million of this deferred revenue balance as revenue based on costs incurred in the quarter compared to the total budget for this performance obligation. License and collaboration revenue of$263.8 million for the nine months ended September 30, 2024, was comprised of: (i)$255.0 million of the$300.0 million upfront cash payment for the Takeda Collaboration Agreement recorded in the first quarter of 2024, and (ii) a total of$8.8 million recorded as revenue during the second and third quarters of 2024.
Research and Development ("R&D") Expenses: Increased by
$5.3 million and$12.0 million for the three and nine months ended September 30, 2024, respectively, from the prior year periods. The increases were primarily due to increases in drug discovery and pre-clinical research expenses.
General and Administrative ("G&A") Expenses: Increased by
$2.5 million for the three months ended September 30, 2024, from the prior year period primarily due to increases in stock-based compensation and other personnel-related expenses. The increase of$9.1 million in G&A expenses for the nine months ended September 30, 2024, from the prior year period was primarily due to$4.6 million in one-time advisory and legal fees related to the Takeda collaboration and increases in stock-based compensation and other personnel-related expenses.
Net Income (Loss): Net loss was (
$33.2) million , or ($0.54) per basic and diluted share, for the three months ended September 30, 2024, as compared to a net loss of ($34.1) million , or ($0.58) per basic and diluted share, for the three months ended September 30, 2023. Net income was$143.5 million , or$2.34 per basic share and$2.22 per diluted share, for the nine months ended September 30, 2024, as compared to a net loss of ($106.3) million , or ($1.91) per basic and diluted share, for the nine months ended September 30, 2023.
About Protagonist
Protagonist Therapeutics is a 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. JNJ-2113 is an oral Interleukin-23 receptor (IL-23R) antagonist licensed to Johnson & Johnson (JNJ) that is currently in Phase 3 development for psoriasis and is nearing completion of Phase 2b development for ulcerative colitis. Following JNJ-2113's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of JNJ-2113 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 into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including IL-17, hepcidin mimetic, and anti-obesity 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 the potential benefits of JNJ-2113 and rusfertide, the timing of JNJ-2113 and rusfertide clinical trials, and timing of developments and announcements in our discovery programs. 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
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
(Amounts in thousands except share and per share data)
|
| Three Months Ended |
|
| Nine Months Ended |
| ||||||||||
|
| September 30, |
|
| September 30, |
| ||||||||||
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| |||||
License and collaboration revenue |
| $ | 4,675 |
|
| $ | - |
|
| $ | 263,795 |
|
| $ | - |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
| 35,970 |
|
|
| 30,664 |
|
|
| 103,224 |
|
|
| 91,262 |
|
General and administrative (1) |
|
| 10,158 |
|
|
| 7,662 |
|
|
| 34,508 |
|
|
| 25,439 |
|
Total operating expenses |
|
| 46,128 |
|
|
| 38,326 |
|
|
| 137,732 |
|
|
| 116,701 |
|
Income (loss) from operations |
|
| (41,453 | ) |
|
| (38,326 | ) |
|
| 126,063 |
|
|
| (116,701 | ) |
Interest income |
|
| 7,682 |
|
|
| 4,252 |
|
|
| 19,462 |
|
|
| 10,656 |
|
Other income (expense), net |
|
| 141 |
|
|
| (31 | ) |
|
| 219 |
|
|
| (245 | ) |
Income (loss) before income tax benefit (expense) |
|
| (33,630 | ) |
|
| (34,105 | ) |
|
| 145,744 |
|
|
| (106,290 | ) |
Income tax benefit (expense) |
|
| 420 |
|
|
| - |
|
|
| (2,230 | ) |
|
| - |
|
Net income (loss) |
| $ | (33,210 | ) |
| $ | (34,105 | ) |
| $ | 143,514 |
|
| $ | (106,290 | ) |
Net income (loss) per share, basic |
| $ | (0.54 | ) |
| $ | (0.58 | ) |
| $ | 2.34 |
|
| $ | (1.91 | ) |
Net income (loss) per share, diluted |
| $ | (0.54 | ) |
| $ | (0.58 | ) |
| $ | 2.22 |
|
| $ | (1.91 | ) |
Weighted-average shares used to compute net income (loss) per share, basic |
|
| 61,767,934 |
|
|
| 59,182,899 |
|
|
| 61,311,310 |
|
|
| 55,542,543 |
|
Weighted-average shares used to compute net income (loss) per share, diluted |
|
| 61,767,934 |
|
|
| 59,182,899 |
|
|
| 64,611,941 |
|
|
| 55,542,543 |
|
(1) Amount includes non-cash stock-based compensation expense.
Stock-based Compensation
(Unaudited, in thousands)
|
| Three Months Ended |
|
| Nine Months Ended |
| ||||||||||
|
| September 30, |
|
| September 30, |
| ||||||||||
|
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| ||||
Research and development |
| $ | 5,212 |
|
| $ | 3,780 |
|
| $ | 15,597 |
|
| $ | 13,171 |
|
General and administrative |
|
| 4,953 |
|
|
| 2,985 |
|
|
| 12,864 |
|
|
| 9,521 |
|
Total stock-based compensation expense |
| $ | 10,165 |
|
| $ | 6,765 |
|
| $ | 28,461 |
|
| $ | 22,692 |
|
Selected Consolidated Balance Sheet Data
(Unaudited, in thousands)
|
| September 30, |
|
| December 31, |
| ||
|
| 2024 |
|
| 2023 |
| ||
Cash, cash equivalents and marketable securities$ |
|
| 583,281 |
|
| $ | 341,617 |
|
Working capital |
|
| 432,191 |
|
|
| 334,303 |
|
Total assets |
|
| 603,857 |
|
|
| 357,951 |
|
Deferred revenue |
|
| 36,205 |
|
|
| - |
|
Accumulated deficit |
|
| (472,196 | ) |
|
| (615,710 | ) |
Total stockholders' equity |
|
| 531,915 |
|
|
| 336,677 |
|
SOURCE: Protagonist Therapeutics
View the original press release on accesswire.com
FAQ
What were Protagonist's (PTGX) Q3 2024 financial results?
When will PTGX report top-line results for JNJ-2113 Phase 3 psoriasis trials?
How much revenue did PTGX recognize from the Takeda collaboration in 2024?
