Protagonist Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results – PRNewswire

NEWARK, Calif., March 10, 2020 /PRNewswire/ --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

PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for Inflammatory Bowel Disease

PN-943:Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

Financial Results

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 http://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 http://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 forbeta-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.

PROTAGONIST THERAPEUTICS, INC.

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 taxes

(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

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Protagonist Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results - PRNewswire