Recent Updates
Recently added Catalysts
PTGX

Protagonist Reports Second Quarter 2024 Financial Results and Provides Corporate Update JNJ-2113 Phase 3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in moderate-to-severe plaque psoriasis expected to complete th

Key Takeaway: Second Quarter 2024 Financial Results and Provides Corporate Update 3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in moderate-to-severe plaque psoriasis expected to complete the primary endpoint portion of the studies in Q4 2024 2b ANTHEM clinical trial in moderate-to

Full Press Release Details

Second Quarter 2024 Financial Results and Provides Corporate Update
3 ICONIC-LEAD and Phase 3 ICONIC-TOTAL clinical trials in moderate-to-severe plaque psoriasis expected to complete the primary endpoint
portion of the studies in Q4 2024
2b ANTHEM clinical trial in moderate-to-severe ulcerative colitis expected to complete the primary endpoint portion of the study in Q4
2 REVIVE study long-term follow-up data in polycythemia vera presented at European Hematology Association
(EHA) 2024; study showed durable hematocrit control, decreased phlebotomy use, long-term tolerability and no new safety signals
results from the 32-week primary endpoint of the Phase 3 VERIFY study expected in Q1 2025
Cash, cash equivalents
and marketable securities of $595.4M as of June 30, 2024, anticipated to provide cash runway through end of 2027
Calif., August 6, 2024 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the
Company") today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.
"During the second quarter of
2024 our team made tremendous strides in the late-stage clinical development of rusfertide and also in leveraging our proprietary discovery
platform for early-stage, but highly differentiated, oral peptides-based discovery programs," said Dinesh V. Patel, Ph.D., the
Company's President and CEO. "We presented updated long-term data from the REVIVE Phase 2 trial at EHA that reaffirms rusfertide's
durability of positive response in polycythemia vera, and we look forward to the Phase 3 VERIFY 32-week primary endpoint readout in Q1
2025. We are excited at the prospect of introducing multiple new development candidates in a variety of indications over the next 12
months where oral peptides would offer a strong differentiation versus existing options. Additionally, our addition to the S&P SmallCap
600 index highlights the value Protagonist brings to shareholders and provides additional visibility within the investment
Dr. Patel continued, "We
are also very pleased with the rapid pace of enrollment in the five different ongoing Phase 3 trials of JNJ-2113 in psoriasis and the
Phase 2b study in ulcerative colitis. With the primary endpoint portion of the
ICONIC-LEAD in moderate-to-severe plaque psoriasis, ICONIC-TOTAL in psoriasis in special body regions, and ANTHEM in ulcerative
colitis studies all expected to be completed this year, we look forward to uncovering the potential and differentiation of JNJ-2113,
the first and only targeted oral IL-23 receptor antagonist (IL23Ri) peptide."
Quarter 2024 Recent Developments and Upcoming Milestones
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV)
Oral IL-23 Receptor Antagonist for Psoriasis (PsO) and Ulcerative Colitis (UC)
ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
ANTHEM (NCT06049017)
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
Pustular/Erythrodermic (NCT06295692)
Second Quarter 2024 Financial Results
Three Months Ended Six Months Ended
June 30, June 30,
(in thousands, except per share amounts) 2024 2023 2024 2023
License and collaboration revenue $ 4,167 $ - $ 259,120 $ -
Research and development expense $ 33,520 $ 33,182 $ 67,254 $ 60,598
General and administrative expense $ 9,440 $ 9,172 $ 24,350 $ 17,777
Net income (loss) $ (30,616 ) $ (38,460 ) $ 176,724 $ (72,185 )
Basic earnings (loss) per share $ (0.50 ) $ (0.68 ) $ 2.89 $ (1.34 )
Diluted earnings (loss) per share $ (0.50 ) $ (0.68 ) $ 2.77 $ (1.34 )
During the second quarter
of 2024, we recognized $4.2 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 $259.1 million for the six months ended June 30,
2024, is 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) the $4.2 million recorded as revenue during the second quarter of 2024.
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235)
in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and
Johnson & Johnson (JNJ) scientists jointly discovered JNJ-2113 as part of Protagonist's Interleukin-23 receptor (IL-23R) antagonist
collaboration with JNJ and followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further
clinical development. JNJ-2113 is currently being pursued in five Phase 3 studies in psoriasis, and a Phase 2b study in ulcerative colitis.
Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development
program for polycythemia vera (PV). The randomized portion of the Phase 2 REVIVE study has been successfully completed, and results were
published in The New England Journal of Medicine in February 2024. The open-label extension (OLE) component of REVIVE has
also been completed and is followed by an additional 2-year long-term extension (LTE) THRIVE study. Enrollment has been completed in
the global Phase 3 VERIFY study of rusfertide in polycythemia vera. Rusfertide is being co-developed and co-commercialized with Takeda
pursuant to a worldwide collaboration and license agreement with Takeda announced in January 2024.
information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at www.protagonist-inc.com.
Note on Forward-Looking Statements
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 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
Media Relations Contact
ENTENTE Network of Companies
PROTAGONIST THERAPEUTICS,
Condensed Consolidated Statements
(Amounts in thousands except
share and per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2024 2023 2024 2023
License and collaboration revenue $ 4,167 $ - $ 259,120 $ -
Operating expenses:
Research and development (1) 33,520 33,182 67,254 60,598
General and administrative (1) 9,440 9,172 24,350 17,777
Total operating expenses 42,960 42,354 91,604 78,375
Income (loss) from operations (38,793 ) (42,354 ) 167,516 (78,375 )
Interest income 7,404 3,913 11,780 6,404
Other income (expense), net 97 (19 ) 78 (214 )
Income (loss) before income tax benefit (expense) (31,292 ) (38,460 ) 179,374 (72,185 )
Income tax benefit (expense) 676 - (2,650 ) -
Net income (loss) $ (30,616 ) $ (38,460 ) $ 176,724 $ (72,185 )
Net income (loss) per share, basic $ (0.50 ) $ (0.68 ) $ 2.89 $ (1.34 )
Net income (loss) per share, diluted $ (0.50 ) $ (0.68 ) $ 2.77 $ (1.34 )
Weighted-average shares used to compute net income (loss) per share, basic 61,305,289 56,775,742 61,080,489 53,691,965
Weighted-average shares used to compute net income (loss) per share, diluted 61,305,289 56,775,742 63,909,633 53,691,965
(1) Amount includes non-cash stock-based
compensation expense.
Stock-based Compensation
Three Months Ended Six Months Ended
June 30, June 30,
2024 2023 2024 2023
Research and development $ 5,097 $ 4,809 $ 10,385 $ 9,391
General and administrative 3,847 3,534 7,911 6,536
Total stock-based compensation expense $ 8,944 $ 8,343 $ 18,296 $ 15,927
PROTAGONIST THERAPEUTICS,
Selected Consolidated Balance Sheet Data
June 30, December 31,
2024 2023
Cash, cash equivalents and marketable securities $ 595,444 $ 341,617
Receivable from collaboration partner 43 10,000
Working capital 529,347 334,303
Total assets 614,629 357,951
Accumulated deficit (438,986 ) (615,710 )
Total stockholders' equity 541,324 336,677
Last updated: Aug 6, 2024