Full Press Release Details
Protagonist Reports First Quarter 2024 Financial
Results and Provides Corporate Update
Entered into a worldwide license and
collaboration agreement for rusfertide with Takeda; Cash runway extended through Q4 20271
Enrollment in both Phase 3 ICONIC LEAD and ICONIC
TOTAL trials of JNJ-2113 in patients with moderate to severe psoriasis is now complete
from the Phase 2b FRONTIER 2, a 52-week long term extension study of JNJ-2113 presented at the American
Academy of Dermatology 2024 Annual Meeting in March
Expect to nominate a development candidate from
oral IL-17 program by end of 2024
Two articles published in the New England Journal
of Medicine reporting results from the Phase 2b FRONTIER 1 study with JNJ-2113 and the Phase 2 REVIVE study with rusfertide
Calif., May 7, 2024 - Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or
"the Company") today reported financial results for the first quarter ended March 31, 2024, and provided a corporate
first quarter of 2024 was an extremely busy and productive time for Protagonist," said Dinesh V. Patel, Ph.D., the Company's
President and CEO. "We announced a transformational partnership with Takeda to develop and commercialize rusfertide that allows
us to reinvest in our core competency in peptide therapeutics and expand our efforts to create a new pipeline of potential blockbusters
and highly differentiated development candidates. We expect to nominate
an oral IL-17 antagonist development candidate this year from our
internal discovery efforts."
Dr. Patel continued: "We are
very pleased with our continued collaboration with Johnson & Johnson and their efforts to position JNJ-2113 as a centerpiece
of its immunology franchise with completion of the two Phase 3 trials in psoriasis expected by the end of the year. The Phase 2 results
recently featured in New England Journal of Medicine and the 52-week long-term extension data presented at the American Academy of Dermatology
conference show that JNJ-2113, the first and only targeted oral IL-23 receptor antagonist (IL23Ri) peptide, maintained skin clearance
in moderate-to-severe plaque psoriasis patients through one year and has the potential to be a best-in-class oral agent for psoriasis.
We look forward to its continued and expanded assessment across the spectrum of other IL-23-mediated diseases, including the results from
the Phase 2b ANTHEM study in ulcerative colitis."
1 Based on Cash, Cash Equivalents and Marketable Securities
as of March 31, 2024, and including the $300m upfront payment received from the worldwide collaboration agreement with Takeda Pharmaceuticals
in April 2024, but excluding all future milestones expected with respect to JNJ-2113 and rusfertide.
Quarter 2023 Recent Developments and Upcoming Milestones
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood
Oral IL-23 Receptor Antagonist
ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
ANTHEM (NCT06049017)
First Quarter 2024 Financial Results
| Three Months Ended | |||||||
| March 31, | |||||||
| (in thousands, except per share amounts) | 2024 | 2023 | |||||
| License and collaboration revenue | $ | 254,953 | $ | - | |||
| Research and development expense | $ | 33,734 | $ | 27,416 | |||
| General and administrative expense | $ | 14,910 | $ | 8,605 | |||
| Net income (loss) | $ | 207,340 | $ | (33,725 | ) | ||
| Basic earnings (loss) per share | $ | 3.41 | $ | (0.67 | ) | ||
| Diluted earnings (loss) per share | $ | 3.26 | $ | (0.67 | ) |
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235)
in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists
jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and
followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development.
Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development
program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results
and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing.
co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in
January 2024 and became effective in March 2024. More information on Protagonist, its
pipeline drug candidates and clinical studies can be found on the Company's website at www.protagonist-inc.com.
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 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.
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| License and collaboration revenue | $ | 254,953 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development (1) | 33,734 | 27,416 | ||||||
| General and administrative (1) | 14,910 | 8,605 | ||||||
| Total operating expenses | 48,644 | 36,021 | ||||||
| Income (loss) from operations | 206,309 | (36,021 | ) | |||||
| Interest income | 4,376 | 2,491 | ||||||
| Other expense, net | (19 | ) | (195 | ) | ||||
| Income (loss) before income tax expense | 210,666 | (33,725 | ) | |||||
| Income tax expense | (3,326 | ) | - | |||||
| Net income (loss) | $ | 207,340 | $ | (33,725 | ) | |||
| Net income (loss) per share, basic | $ | 3.41 | $ | (0.67 | ) | |||
| Net income (loss) per share, diluted | $ | 3.26 | $ | (0.67 | ) | |||
| Weighted-average shares used to compute net income (loss) per share, basic | 60,855,689 | 50,573,650 | ||||||
| Weighted-average shares used to compute net income (loss) per share, diluted | 63,595,328 | 50,573,650 |
includes non-cash stock-based compensation expense.
PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Research and development | $ | 5,288 | $ | 4,582 | ||||
| General and administrative | 4,064 | 3,002 | ||||||
| Total stock-based compensation expense | $ | 9,352 | $ | 7,584 |
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 322,635 | $ | 341,617 | ||||
| Receivable from collaboration partner | 300,043 | 10,000 | ||||||
| Working capital | 587,643 | 334,303 | ||||||
| Total assets | 629,276 | 357,951 | ||||||
| Accumulated deficit | (408,370 | ) | (615,710 | ) | ||||
| Total stockholders' equity | 560,444 | 336,677 |