UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 8, 2019

 


 

PROTAGONIST THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware

 

001-37852

 

98-0505495

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

Protagonist Therapeutics, Inc.

7707 Gateway Blvd., Suite 140

Newark, California 94560-1160

(Address of principal executive offices, including zip code)

 

(510) 474-0170

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report.)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o                            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.00001

 

PTGX

 

The Nasdaq Stock Market, LLC

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On May 8, 2019, Protagonist Therapeutics, Inc. reported its financial results for the quarter ended March 31, 2019. A copy of the press release titled “Protagonist Therapeutics Reports First Quarter 2019 Financial Results,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

 

Description

 

 

 

99.1

 

Press release, dated May 8, 2019, titled “Protagonist Therapeutics Reports First Quarter 2019 Financial Results.”

 

The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Protagonist Therapeutics, Inc.

 

 

Dated:May 8, 2019

 

 

 

 

By:

/s/ Dinesh V. Patel, Ph.D.

 

 

Dinesh V. Patel, Ph.D.

 

 

President and Chief Executive Officer

 

3


Exhibit 99.1

 

 

Protagonist Therapeutics Reports First Quarter 2019 Financial Results

 

— PTG-200 collaboration agreement with Janssen Biotech expanded to include second generation oral IL-23 receptor antagonists; expanded agreement triggers $25 million milestone payment to Protagonist

 

— Protagonist appoints Samuel Saks, M.D., as Chief Medical Officer and Suneel Gupta, Ph.D., as Chief Development Officer —

 

— Preliminary results from the Phase 2 TRANSCEND study of PTG-300 for the treatment of beta thalassemia expected in the second half of 2019 —

 

— Initial results from the Phase 1 study of PN-943 expected in the second quarter of 2019 —

 

NEWARK, Calif., May 8, 2019 — Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today reported its financial results for the first quarter ended March 31, 2019. The Company also announced changes to the executive management team, with the appointment of Samuel Saks, M.D., as Chief Medical Officer. In addition, Suneel Gupta, Ph.D., current Executive Vice President of Clinical Operations and Pharmacology, has been promoted to the role of Chief Development Officer.

 

“We are pleased to have Dr. Saks expand his involvement with Protagonist as our programs transition to mid-to-late-stage development,” commented Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist Therapeutics. “His contributions as Chief Development Officer have been invaluable over the past year as multiple programs have progressed to different stages of development. In addition, we welcome Dr. Gupta to the senior executive team, bringing an abundance of experience across all areas of pharmaceutical product development as our programs continue to mature in the development pipeline. These updates to management serve to broaden and strengthen our clinical development capabilities at a critical inflection point as we move forward with the development of our three clinical candidates, PTG-300, PTG-200 and PN-943. We are pleased to report that we are well financed to support all of our programs through the end of 2020.”

 

In conjunction with the appointment of Dr. Saks to his new role at the Company, Richard Shames, M.D., Chief Medical Officer of Protagonist, will transition to the role of clinical advisor.

 

Dr. Patel continued, “We are grateful for Dr. Shames’ involvement over the past several years as we have worked together to bring multiple programs from preclinical into clinical development, and are pleased to have him participate as a clinical advisor as we continue to update and expand the management team.”

 


 

Product Development Update:

 

PTG-300

 

·                  In January, Protagonist announced the initiation of dosing in the Phase 2 TRANSCEND study, a single-arm, open label, global study of injectable hepcidin mimetic PTG-300 in the treatment of patients with transfusion-dependent or non-transfusion dependent beta thalassemia. Preliminary results from this Phase 2 trial are expected in the second half of 2019.

·                  The Company expects to begin clinical development of PTG-300 in a second indication in the second half of 2019.

 

PTG-200

 

·                  As recently announced, the PTG-200 collaboration agreement with Janssen Biotech has been expanded to include second generation oral IL-23 receptor antagonists, with Protagonist receiving a $25 million milestone payment triggered by the expanded agreement.

·                  Protagonist and Janssen Biotech are working towards filing a U.S. IND application to support a global Phase 2 clinical study in patients with Crohn’s disease. This IND filing is expected in the second quarter of 2019.

 

PN-943

 

·                  Protagonist announced the initiation of dosing in a Phase 1 study of PN-943, which is being developed as a potential novel oral therapy for patients with inflammatory bowel disease. The study will evaluate safety, pharmacokinetics, and pharmacodynamic readouts of target engagement as measured by blood receptor occupancy in healthy volunteers. Top-line results from this Phase 1 study are expected in the second quarter of 2019.

·                  The PN-943 Phase 1 data is expected to provide information that will inform the design of a Phase 2 study of PN-943 in patients with ulcerative colitis, with an expected U.S. IND filing in late 2019.

·                  Preclinical research findings describing the properties of PN-943 have been selected for an oral presentation in a Distinguished Abstract Plenary session on Sunday, May 19, 2019, at the Digestive Diseases Week Conference in San Diego.

 

Financial Results

 

Protagonist reported a net loss of $14.1 million for the first quarter of 2019, as compared to a net loss of $7.7 million for the same period of 2018. The increase in net loss was driven primarily by a decrease in license and collaboration revenue recognized during the first quarter of 2019. The net loss for the first quarter of 2019 includes non-cash stock-based compensation of $2.0 million, as compared to $1.2 million for the same period of 2018.

 


 

License and collaboration revenue, comprised both of revenue recognition relating to the $50 million upfront payment received from Janssen Biotech in 2017 and the services performed under the collaboration agreement, was $1.6 million for the first quarter of 2019 compared to $10.8 million for the same period of 2018. The year over year decrease in license and collaboration revenue is primarily related to the Company approaching, during 2019, the end of the revenue recognition phase of the $50 million upfront payment received from Janssen Biotech in 2017. The Company continued to deliver compound supply services under the Janssen collaboration agreement in the first quarter of 2019.

 

R&D expenses for the first quarter of 2019 were $12.4 million, which decreased from $15.4 million for the same period of the prior year. The decrease in R&D expenses was primarily due to a decrease in costs on our former development candidate PTG-100 and decreased expenditures related to our shared expenses on PTG-200 under the Janssen collaboration agreement, offset by increased costs related to moving forward our product candidates PTG-300 and PN-943. These R&D costs are primarily related to contract manufacturing and the preparation for and conduct of clinical trials. R&D expenses for the quarter also include an increase in salaries and employee-related expenses due to an increase in stock-based compensation expense.

 

G&A expenses for the first quarter of 2019 were $3.8 million, as compared to $3.6 million for the same period in the prior year. The increase in G&A expense was due primarily to increases related to supporting the growth of our operations and stock-based compensation expense.

 

Protagonist ended the first quarter of 2019 with $112.5 million in cash, cash equivalents and investments. Protagonist expects to have sufficient financial resources to fund operations to the end of 2020.

 

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 transform existing treatment paradigms for patients with significant unmet medical needs. PTG-300 is an injectable hepcidin mimetic for the potential treatment of anemia and iron overload related rare blood diseases with an initial focus on beta thalassemia. PTG-200 is an oral gut-restricted interleukin-23 receptor antagonist in development for the treatment of inflammatory bowel disease. The Company has entered into a worldwide license and collaboration agreement with Janssen Biotech for the clinical development of PTG-200. PN-943 is an oral, gut-restricted alpha-4-beta-7 integrin antagonist peptide in development for the treatment of inflammatory bowel disease.

 


 

Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and Brisbane, Queensland, Australia. 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, our collaborations and milestone payments we may receive under them, the initiation and availability of results of our clinical trials, our research and development plans, the utility of our intellectual property,  and the sufficiency of our financial resources. 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, 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 three months ended March 31, 2019, to be 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)

 

 

 

Three Months Ended
March 31,

 

 

 

2019

 

2018

 

 

 

 

 

 

 

License and collaboration revenue - related party

 

$

1,560

 

$

10,781

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

12,444

 

15,368

 

 

 

 

 

 

 

General and administrative

 

3,764

 

3,642

 

 

 

 

 

 

 

Total operating expenses

 

16,208

 

19,010

 

 

 

 

 

 

 

Loss from operations

 

(14,648

)

(8,229

)

 

 

 

 

 

 

Interest income

 

728

 

568

 

 

 

 

 

 

 

Loss before income tax expense

 

(13,920

)

(7,661

)

 

 

 

 

 

 

Income tax expense

 

(183

)

 

 

 

 

 

 

 

Net loss

 

$

(14,103

)

$

(7,661

)

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.58

)

$

(0.36

)

 

 

 

 

 

 

Weighted-average shares used to compute net loss per share, basic and diluted

 

24,297,576

 

21,112,393

 

 


 

PROTAGONIST THERAPEUTICS, INC.

Selected Condensed Consolidated Balance Sheet Data

(In thousands)

 

 

 

March 31,

 

December 31,

 

 

 

2019

 

2018

 

Consolidated Balance Sheet Data:

 

 

 

 

 

Cash, cash equivalents and available-for-sale securities

 

$

112,546

 

$

128,853

 

Working capital

 

$

98,496

 

$

  111,345

 

Total assets

 

$

132,248

 

$

  139,472

 

Deferred revenue — related party

 

$

7,001

 

$

8,223

 

Accumulated deficit

 

$

(154,577

)

$

(140,474

)

Total stockholders’ equity

 

$

100,825

 

$

  112,515

 

 

###

 

Contact:

 

Solebury Trout

Rich Allan (media)

Tel: +1 646-378-2958

Email: rallan@soleburytrout.com

 

Marcy Nanus (investors)

Tel: +1 646-378-2927

Email: mnanus@soleburytrout.com