Full Press Release Details
Therapeutics Reports Second Quarter Financial Results and Provides Corporate Update
Company to host webinar highlighting the PTG-300 program market opportunity in polycythemia vera --
PTG-300 received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of polycythemia vera --
Financial resources expected to support operations through mid-2023 --
NEWARK, Calif., Aug. 6,
2020 -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today reported financial results for the second quarter ended June 30, 2020,
and provided an update on clinical development programs.
"We have succeeded in bringing three differentiated candidates
from de novo discovery into Phase 2 development," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief
Executive Officer. "Each of these candidates has unique attributes that address specific unmet needs in diverse diseases,
such as blood disorders with PTG-300 and inflammatory bowel disease with PTG-200 and PN-943. The hepcidin mimetic PTG-300 makes
use of the iron homeostasis mechanism of a natural hormone and has demonstrated potential in the treatment of polycythemia vera.
We expect to initiate a pivotal study for PTG-300 in 2021 after discussions with the regulatory agencies. PN-943 and PTG-200 are
both oral, gut-restricted candidates for the potential treatment of inflammatory bowel disease. PTG-200 is an IL-23 receptor antagonist
partnered with Janssen and is currently in a Phase 2 Crohn's study. We recently initiated screening of patients for our Phase
2 study of PN-943 in ulcerative colitis. Finally, we are well financed and recently raised $122 million through a successful secondary
offering and use of our ATM program, which enables us to support planned operations through mid-2023."
Product Development and Corporate Update
PTG-300: Injectable Hepcidin Mimetic for Polycythemia Vera and
Other Blood Disorders
PN-943: Oral Alpha-4-Beta-7
Integrin Antagonist for Inflammatory Bowel Disease
Oral IL-23 Receptor Antagonists
(Janssen Biotech and Protagonist Collaboration)
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. The Company currently has three clinical-stage assets.
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. The Company has a worldwide license and collaboration
agreement with Janssen Biotech, Inc., for the development of PTG-200. 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 for our ongoing clinical
programs, our plans for future clinical trials, the potential of PTG-300 as a possible treatment for polycythemia vera
and other blood disorders, the potential of PTG-200 and PN-943 as possible treatments for inflammatory bowel disease, the potential
of a pivotal study for PTG-300 in 2021, the potential of our Phase 2 study of PN-943 in ulcerative colitis, the initiation
and availability of results of our clinical trials, 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 "potential," "expect,"
"plan," "estimate," "will," 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 Biotech,
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 and risks related to the global COVID-19 pandemic and actions taken to slow its spread. 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 period ended June 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
Consolidated Balance Sheet Data
| June 30, 2020 | December 31, 2019 | |||||||
| Cash, cash equivalents and marketable securities | $ | 208,665 | $ | 133,017 | ||||
| Working capital | 182,106 | 109,905 | ||||||
| Total assets | 224,980 | 154,917 | ||||||
| Long-term debt, net | -- | 9,794 | ||||||
| Deferred revenue - related party | 34,014 | 41,530 | ||||||
| Accumulated deficit | (257,162 | ) | (217,661 | ) | ||||
| Total stockholders' equity | 167,485 | 79,964 |
Consolidated Statements of Operations
in thousands except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and collaboration revenue - related party | $ | 6,217 | $ | (8,189 | ) | $ | 9,864 | $ | (6,629 | ) | ||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | 20,257 | 19,355 | 39,025 | 31,799 | ||||||||||||
| General and administrative (1) | 4,177 | 3,863 | 8,753 | 7,627 | ||||||||||||
| Total operating expenses | 24,434 | 23,218 | 47,778 | 39,426 | ||||||||||||
| Loss from operations | (18,217 | ) | (31,407 | ) | (37,914 | ) | (46,055 | ) | ||||||||
| Interest income | 207 | 641 | 733 | 1,372 | ||||||||||||
| Interest expense | (209 | ) | -- | (452 | ) | -- | ||||||||||
| Loss on early repayment of debt | (585 | ) | -- | (585 | ) | -- | ||||||||||
| Other income (expense), net | 512 | (37 | ) | 22 | (39 | ) | ||||||||||
| Loss before income taxes | (18,292 | ) | (30,803 | ) | (38,196 | ) | (44,722 | ) | ||||||||
| Income tax (expense) benefit | (1,129 | ) | 1,629 | (1,305 | ) | 1,445 | ||||||||||
| Net loss | $ | (19,421 | ) | $ | (29,174 | ) | $ | (39,501 | ) | $ | (43,277 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.59 | ) | $ | (1.18 | ) | $ | (1.31 | ) | $ | (1.77 | ) | ||||
| Weighted-average shares used to compute net loss per share, basic and diluted | 32,799,691 | 24,662,779 | 30,251,805 | 24,481,186 |
(1)Amounts include non-cash stock-based compensation expense as follows (in thousands):
| Stock-based compensation | Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Research and development | $ | 1,026 | $ | 977 | $ | 2,092 | $ | 2,100 | ||||||||
| General and administrative | 970 | 1,036 | 1,952 | 1,892 | ||||||||||||
| Total stock-based compensation expense | $ | 1,996 | $ | 2,013 | $ | 4,044 | $ | 3,992 |
Tel: +1 646-378-2958
Email: rallan@soleburytrout.com
Brian Korb (investors)
Tel: +1 646-378-2923
Email: bkorb@soleburytrout.com