Full Press Release Details
Third Quarter 2024 Financial Results and Provides Corporate Update
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 $583.3 million as of September 30, 2024, anticipated to provide cash runway through end of 2027
NEWARK, Calif., 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."
Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia
JNJ-2113: Oral IL-23 Receptor Antagonist
VERIFY (NCT05210790)
(NCT06095115) and ICONIC-TOTAL (NCT06095102)
1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
5 Pustular/Erythrodermic
Third Quarter 2024 Financial Results
| 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. |
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/.
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
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PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share
| 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 |
includes non-cash stock-based compensation expense.
(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 |