Full Press Release Details
Protagonist Therapeutics Reports Third
Quarter Financial Results and Provides Corporate Update
-- Updated Phase 2 results for hepcidin
mimetic PTG-300 in polycythemia vera accepted for oral presentation at the ASH Annual Meeting in December 2020 --
-- PTG-300 received European Medicine
Agency (EMA) Orphan Drug Designation for the treatment of polycythemia vera --
-- Company is advancing additional oral
IL-23 receptor antagonists into clinical development in collaboration with Janssen --
NEWARK, Calif., November 4, 2020 -- Protagonist Therapeutics,
Inc. (Nasdaq:PTGX) today reported its financial results for the third quarter ended September 30, 2020, and provided a corporate
"The three clinical assets PTG-300, PN-943 and PTG-200,
all discovered through our peptide technology platform, continue to make progress in Phase 2 clinical proof-of-concept studies,"
commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We look forward to sharing updated
clinical data in December from our Phase 2 study of PTG-300 in patients with polycythemia vera and see significant opportunity
for PTG-300 to address unmet needs and improve upon the current standards of care."
Dr. Patel continued, "We are moving forward with our
ongoing Phase 2 clinical programs with the oral alpha-4-beta-7 integrin antagonist PN-943 in patients with ulcerative colitis,
and the oral interleukin-23 receptor antagonist PTG-200 in patients with Crohn's disease. In addition, we're encouraged
by the steady progress in our ongoing collaboration with Janssen, and recently announced the selection of two additional oral
interleukin-23 receptor antagonists, PN-235 and PN-232, for advancement into clinical development. These candidates provide several
strategic options for development in multiple indications."
Product Development and Corporate Update
PTG-300: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia
Vera and Other Blood Disorders
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical
company that utilizes a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant
unmet medical needs and transform existing treatment paradigms for patients. PTG-300 is an injectable hepcidin mimetic in development
for the treatment of polycythemia vera and other blood disorders. PTG-200 is an orally delivered, gut-restricted, interleukin-23
receptor specific antagonist peptide in development for the treatment of inflammatory bowel disease, with Crohn's disease as the
initial indication. In addition to PTG-200, two oral peptide interleukin-23 receptor antagonist candidates from a collaboration
with Janssen Biotech, Inc., are in development and have been selected for advancement into clinical studies. PN-943 is an orally
delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in development for the treatment of inflammatory
bowel disease, with ulcerative colitis as the initial targeted indication.
Protagonist is headquartered in Newark, California. For further
information, please visit 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 our intentions or current expectations concerning, among other things, the potential of our product candidates
to improve standards of care, our ability to fund operations into future periods, and our expectations regarding the timing of
the initiation of clinical trials. 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 agreement
with Janssen, the impact of the current COVID-19 pandemic on our discovery and development efforts, 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 Quarterly Report on Form 10-Q for
the quarter ended September 30, 2020, 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
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet
| September 30, 2020 | December 31, 2019 | |||||||
| Cash, cash equivalents and marketable securities | $ | 199,999 | $ | 133,017 | ||||
| Working capital | 165,588 | 109,905 | ||||||
| Total assets | 217,320 | 154,917 | ||||||
| Long-term debt, net | -- | 9,794 | ||||||
| Deferred revenue - related party | 20,877 | 41,530 | ||||||
| Accumulated deficit | (264,925 | ) | (217,661 | ) | ||||
| Total stockholders' equity | 169,590 | 79,964 |
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of
(Amounts in thousands except share and
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and collaboration revenue - related party | $ | 13,114 | $ | 4,141 | $ | 22,978 | $ | (2,488 | ) | |||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 15,995 | 17,293 | 55,020 | 49,092 | ||||||||||||
| General and administrative (1) | 4,891 | 4,015 | 13,644 | 11,642 | ||||||||||||
| Total operating expenses | 20,886 | 21,308 | 68,664 | 60,734 | ||||||||||||
| Loss from operations | (7,772 | ) | (17,167 | ) | (45,686 | ) | (63,222 | ) | ||||||||
| Interest income | 87 | 762 | 820 | 2,134 | ||||||||||||
| Interest expense | (19 | ) | -- | (471 | ) | -- | ||||||||||
| Loss on early repayment of debt | -- | -- | (585 | ) | -- | |||||||||||
| Other expense, net | (59 | ) | (106 | ) | (37 | ) | (145 | ) | ||||||||
| Loss before income taxes | (7,763 | ) | (16,511 | ) | (45,959 | ) | (61,233 | ) | ||||||||
| Income tax (expense) benefit | -- | 102 | (1,305 | ) | 1,547 | |||||||||||
| Net loss | $ | (7,763 | ) | $ | (16,409 | ) | $ | (47,264 | ) | $ | (59,686 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.21 | ) | $ | (0.61 | ) | $ | (1.45 | ) | $ | (2.36 | ) | ||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 37,386,881 | 29,956,957 | 32,647,524 | 25,315,512 |
(1)Amounts include non-cash stock-based compensation expense as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| Stock-based compensation | 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Research and development | $ | 1,006 | $ | 1,137 | $ | 3,098 | $ | 3,237 | ||||||||
| General and administrative | 882 | 1,064 | 2,834 | 2,956 | ||||||||||||
| Total stock-based compensation expense | $ | 1,888 | $ | 2,201 | $ | 5,932 | $ | 6,193 |
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Brian Korb (investors)
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