Full Press Release Details
Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
Therapeutic candidate PTG-300 under evaluation in Phase 2 proof of concept studies in multiple blood disorder indications --
Two differentiated, orally administered candidates PTG-200 and PN-943 in clinical-stage development for the treatment of inflammatory
Sufficient financial resources to support development of pipeline assets through the end of 2021 --
Management to host conference call today at 4:30 p.m. EDT --
NEWARK, Calif., March
10, 2020 -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial results for the fourth quarter and full year
ended December 31, 2019, and provided an update on its clinical development programs.
"We are pleased to have made great progress in 2019, creating
multiple opportunities to execute on our clinical development plans with three platform-generated therapeutic candidates,"
commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "Our priorities for 2020 include evaluating
PTG-300 in multiple blood disorders with the intent of selecting the first clinical indication
for a pivotal study, continuing Phase 2 development of PTG-200 with our partner Janssen Biotech, and advancing PN-943 into
Phase 2 development in ulcerative colitis. Our financial position provides us with
sufficient resources through the end of 2021 which should enable us to reach definitive conclusions for all of the ongoing clinical
proof of concept studies."
Product Development Update
PTG-300: Injectable Hepcidin Mimetic for Blood Disorders
| The Company is conducting Phase 2 proof of concept studies with PTG-300 in patients with beta-thalassemia, polycythemia vera and hereditary hemochromatosis. | ||
| In December 2019, the Company reported observations of dose-related reductions from high baseline serum iron and transferrin saturation (TSAT) levels in the ongoing open-label TRANSCEND Phase 2 study of PTG-300, supporting continued evaluation with additional dose regimens and longer follow-up time periods. | ||
| An investigator-sponsored study of PTG-300 in patients with myelodysplastic syndromes, a fourth potential indication for PTG-300, is expected to begin in the first half of 2020. |
PTG-200 (JNJ-67864238):
Oral IL-23 Receptor Antagonist for Inflammatory Bowel Disease
| Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (or JNJ-67864238) through completion of a Phase 2a study in patients with moderate-to-severe Crohn's disease, with the anticipation of completion in the first half of 2021. | ||
| Protagonist achieved milestones leading to payments from Janssen Biotech of $25 million received in 2019 triggered by the decision to advance PTG-200 in a Phase 2a study and expansion of the existing collaboration agreement, and $5 million received in early 2020 on the nomination of a second-generation oral IL-23 receptor antagonist. |
PN-943: Oral Alpha-4-Beta-7
Integrin Antagonist for Inflammatory Bowel Disease
Conference Call and Webcast Information
Protagonist executives will host a conference call at 4:30
p.m. EDT/1:30 p.m. PDT today. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and
refer to conference ID number 5591627. A live and archived webcast of the call will also be accessible in the Investors section
of the Company's website at www.protagonist-inc.com.
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 drugs to address significant
unmet medical needs and transform existing treatment paradigms for patients. The Company currently has three different assets in
various stages of clinical development. All three were discovered through the use of the Company's peptide technology
platform. PTG-300 is an injectable hepcidin mimetic in development for the potential treatment of iron overload and related blood
disorders, including hereditary hemochromatosis and rare diseases such as beta-thalassemia and polycythemia vera. PTG-200 is an
orally delivered, gut-restricted interleukin-23 receptor specific antagonist peptide in Phase 2 clinical development for the potential
treatment of inflammatory bowel disease, with Crohn's disease as the initial indication. The Company has a worldwide license and
collaboration agreement with Janssen Biotech, Inc., for the clinical development of PTG-200. PN-943 is an orally delivered, gut-restricted
alpha-4-beta-7 integrin specific antagonist peptide in clinical development for the potential treatment of inflammatory bowel disease,
with a Phase 2 ulcerative colitis study expected to commence in the second quarter of 2020.
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 for our
clinical programs, the potential of PTG-300 as a possible treatment for beta-thalassemia,
polycythemia vera, hereditary hemochromatosis and myelodysplastic syndromes, our plans for future clinical trials, the
potential of PTG-200 and PN-943 as possible treatments for inflammatory bowel disease, the initiation and availability of
results of our clinical trials and the sufficiency of our financial resources, our ability to fund our clinical trials, the
initiation of and enrollment of patients in our clinical trials, the results of clinical trials and the outlook for our other
programs. In some cases, you can identify these statements by forward-looking words such as "plan,"
"will," "expect," "potential," 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, our ability to use and expand our programs to build a pipeline of product candidates, and our ability to obtain
and maintain regulatory approval of 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 Annual Report on Form 10-K for the year ended December 31, 2019, 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.
Consolidated Statements of Operations
(In thousands, except share and per share data)
| For the Three Months Ended December 31, | For the Year Ended December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| License and collaboration revenue - related party | $ | 2,719 | $ | 2,353 | $ | 231 | $ | 30,925 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 15,911 | 14,248 | 65,003 | 59,497 | ||||||||||||
| General and administrative (1) | 4,107 | 3,517 | 15,749 | 13,697 | ||||||||||||
| Total operating expenses | 20,018 | 17,765 | 80,752 | 73,194 | ||||||||||||
| Loss from operations | (17,299 | ) | (15,412 | ) | (80,521 | ) | (42,269 | ) | ||||||||
| Interest income | 679 | 748 | 2,813 | 2,566 | ||||||||||||
| Interest expense | (167 | ) | -- | (169 | ) | -- | ||||||||||
| Other income (expense), net | 142 | -- | (1 | ) | (20 | ) | ||||||||||
| Loss before income tax (expense) benefit | (16,645 | ) | (14,664 | ) | (77,878 | ) | (39,723 | ) | ||||||||
| Income tax (expense) benefit | (856 | ) | 799 | 691 | 799 | |||||||||||
| Net loss | $ | (17,501 | ) | $ | (13,865 | ) | $ | (77,187 | ) | $ | (38,924 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.63 | ) | $ | (0.57 | ) | $ | (2.98 | ) | $ | (1.74 | ) | ||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 27,610,696 | 24,186,356 | 25,894,024 | 22,364,515 |
(1) Amounts include non-cash stock-based compensation expense as follows (in thousands):
| For the Three Months Ended December 31, | For the Year Ended December 31, | |||||||||||||||
| Stock-based compensation | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Research and development | $ | 1,113 | $ | 1,000 | $ | 4,350 | $ | 3,424 | ||||||||
| General and administrative | 1,047 | 1,072 | 4,003 | 3,495 | ||||||||||||
| Total stock-based compensation expense | $ | 2,160 | $ | 2,072 | $ | 8,353 | $ | 6,919 |
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
| December 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Cash, cash equivalents and marketable securities | $ | 133,017 | $ | 128,853 | ||||
| Working capital | $ | 109,905 | $ | 111,345 | ||||
| Total assets | $ | 154,917 | $ | 139,472 | ||||
| Long-term debt, net | $ | 9,794 | $ | -- | ||||
| Deferred revenue - related party | $ | 41,530 | $ | 8,223 | ||||
| Accumulated deficit | $ | (217,661 | ) | $ | (140,474 | ) | ||
| Total stockholders' equity | $ | 79,964 | $ | 112,515 |
Tel: +1 646-378-2958
Email: rallan@soleburytrout.com
Brian Korb (investors)
Tel: +1 646-378-2923
Email: bkorb@soleburytrout.com