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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 4, 2021

 

 

 

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:

 

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

 

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

 

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

 

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

 

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

 

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

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 4, 2021, Protagonist Therapeutics, Inc. reported its financial results for the quarter ended March 31, 2021. A copy of the press release titled “Protagonist Reports First Quarter 2021 Financial Results and Provides Corporate Update” 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 No.   Description
99.1   Press release, dated May 4, 2021, titled “Protagonist Reports First Quarter 2021 Financial Results and Provides Corporate Update.”
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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 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.

 

 

 

 

SIGNATURE

 

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 4, 2021  
  By: /s/ Don Kalkofen 
  Don Kalkofen
    Chief Financial Officer

 

 

 

 

 

Exhibit 99.1

 

 

Protagonist Reports First Quarter 2021

Financial Results and Provides Corporate Update

 

NEWARK, California, May 4, 2021 – Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or “the Company”) today reported financial results for the first quarter of 2021 ended March 31, 2021 and provided a corporate update.

 

“Our progress this quarter affirms the strength of our pipeline and execution capabilities,” said Dinesh Patel, PhD, Protagonist’s President and Chief Executive Officer. “For our lead drug candidate, rusfertide in polycythemia vera, we have completed enrollment for our Phase 2 study and confirmed the registrational path forward based on recent engagement with both U.S. and European regulators. We look forward to providing an interim update from our ongoing Phase 2 study at a major medical conference in the second quarter of 2021.”

 

Dr. Patel continued, “We are very pleased with the rate of enrollment in our ongoing Phase 2 study of the oral alpha-4-beta-7-integrin antagonist PN-943. For our oral IL-23 receptor antagonists, we expect to dose the first subject in the Phase 1 study of PN-232 in the second quarter of 2021 and intend to complete both this trial and the Phase 1 trial of PN-235 during the second half of 2021. There is excellent movement forward across our full portfolio, driven by our commitment to patients in need of new and better therapeutic options.”

 

PRODUCT DEVELOPMENT AND CORPORATE UPDATE

 

Disorders of Red Blood Cells and Iron Regulation

 

Rusfertide (PTG-300)

 

Investigational, injectable, hepcidin mimetic discovered through our peptide technology platform. Hepcidin is a natural hormone that regulates iron homeostasis and controls the absorption, storage, and distribution of iron in the body. Rusfertide is currently being evaluated for disorders associated with iron overload and excessive erythrocytosis (red blood cell production).

 

·In March 2021, following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) and written comments from the European Medicines Agency (“EMA”), Protagonist has advanced its preparations for a global pivotal study of rusfertide in polycythemia vera (“PV”). The Company plans to initiate this Phase 3 study in early 2022.

 

·In April 2021, Protagonist announced completion of enrollment in the ongoing Phase 2 study of rusfertide in PV. The Company plans to present updated interim data from this study at an upcoming medical meeting in the second quarter of 2021.
   
 · In the second half of 2021, Protagonist expects to announce preliminary results from the ongoing Phase 2 open-label proof-of-concept study of rusfertide in patients with hereditary hemochromatosis ("HH").

 

·In addition to ongoing studies in PV and HH, the Company expects to select a third indication for rusfertide in 2021.

 

 

 

 

Inflammatory Bowel Diseases

 

PN-943

 

Investigational, orally delivered, gut-restricted alpha-4-beta-7 specific integrin antagonist for inflammatory bowel diseases.

 

·The 150-patient Phase 2 “IDEAL” study evaluating the safety, tolerability and efficacy of PN-943 in patients with moderate to severe ulcerative colitis is underway, and the study is on track for completion in 2022.

 

Oral IL-23 Receptor Antagonists

 

PTG-200; PN-235; PN-232 (Janssen collaboration)

 

Investigational, orally delivered, IL-23 receptor antagonists. Protagonist has entered into a worldwide agreement with Janssen to co-develop and commercialize these drug candidates.

 

·In the second quarter of 2021, Protagonist expects to dose the first subject in the Phase 1 study of PN-232. The Company expects to complete both this trial and the Phase 1 trial of PN-235 in the second half of 2021. PN-232 and PN-235 are part of the oral IL-23 pathway blocker portfolio strategy, pursued in collaboration with Janssen.
   
·Enrollment continues for the Phase 2a proof-of-concept PRISM study of PTG-200, a first-generation drug candidate for patients with moderate to severe Crohn's disease.

 

First Quarter 2021 Financial Results

 

·Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2021 were $279.7 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the first half of 2024.

 

·License and Collaboration Revenue: License and collaboration revenue was $6.2 million for the first quarter of 2021 compared to $3.6 million for the same period of 2020. The increase was primarily due to the additional services provided to Janssen under the collaboration agreement during 2021 related to PN-232 and PN-235.

 

·Research and Development (“R&D”) Expenses: R&D expenses for the first quarter 2021 were $24.2 million as compared to $18.8 million for the same period of 2020. The increase was primarily due to costs associated with advancing our clinical trials with our pipeline assets of rusfertide and PN-943, as well as our three IL-23 receptor antagonist assets under the Janssen collaboration (PTG-200, PN-235 and PN-232).

 

·General and Administrative (“G&A”) Expenses: G&A expenses for the first quarter 2021 were $6.0 million as compared to $4.6 million for the same periods of 2020. The increase was primarily related to professional fees and employee compensation related expenses supporting the growth in our operations.

 

·Net Loss: The first quarter net loss was $24.0 million, or a net loss of $0.54 per share, compared to the first quarter of 2020 net loss of $20.1 million, or a net loss of $0.72 per share.

 

 

 

 

About Protagonist Therapeutics

 

Protagonist Therapeutics is a clinical stage biopharmaceutical company with multiple peptide-based investigational new chemical entities in different stages of development. Rusfertide (PTG-300) is an investigational, injectable hepcidin mimetic in a Phase 2 proof-of-concept clinical trial for polycythemia vera, and a separate Phase 2 clinical study for hereditary hemochromatosis. Based on the feedback provided by the FDA and EU regulatory authorities, the Company plans to initiate a single, global, Phase 3 randomized, placebo-controlled trial evaluating the efficacy of a once weekly, subcutaneously self-administered dose of rusfertide.

 

PN-943 is an investigational orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide in a 150 patient Phase 2 study for the potential treatment of inflammatory bowel disease, with ulcerative colitis as the initial targeted indication. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor specific antagonist peptide in a Phase 2 clinical trial for Crohn's disease. Two additional second-generation oral interleukin-23 receptor antagonist candidates, PN-235 and PN-232, are in early stages of clinical development. The Company has developed a proprietary technology platform to discover and develop novel peptide-based therapeutics to address significant unmet medical needs and transform existing treatment paradigms. 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, our plans to conduct a Phase 3 trial evaluating rusfertide for PV, the timing of initiation and completion of other clinical trials and the timing of clinical data announcements. 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 ongoing 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 three months ended March 31, 2021, 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.
Condensed Consolidated Statements of Operations

(Unaudited)
(Amounts in thousands except share and per share data)

 

   Three Months Ended 
   March 31, 
   2021   2020 
License and collaboration revenue - related party  $6,189   $3,647 
Operating expenses:          
Research and development (1)   24,245    18,768 
General and administrative (1)   5,965    4,576 
Total operating expenses   30,210    23,344 
Loss from operations   (24,021)   (19,697)
Interest income   102    526 
Interest expense       (243)
Other expense, net   (79)   (490)
Loss before income tax expense   (23,998)   (19,904)
Income tax expense   -    (176)
Net loss  $(23,998)  $(20,080)
Net loss per share, basic and diluted  $(0.54)  $(0.72)
Weighted-average shares used to compute net loss per share, basic and diluted   44,224,169    27,703,918 

 

(1) Amounts include non-cash stock-based compensation expense.

 

 

 

 

Stock-based Compensation

(In thousands)

 

   Three Months Ended 
   March 31, 
   2021   2020 
Research and development  $1,475   $1,066 
General and administrative   1,185    982 
Total stock-based compensation expense  $2,660   $2,048 

 

PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)

 

   March 31,   December 31, 
   2021   2020 
Cash, cash equivalents and marketable securities  $279,730   $307,809 
Working Capital   250,993    275,365 
Total assets   298,072    324,468 
Deferred revenue-related party   5,768    14,477 
Accumulated deficit   (307,809)   (283,811)
Total stockholders' equity   259,334    279,606 

 

SOURCE Protagonist Therapeutics, Inc.

 

Investor Relations & Media: Jami Taylor, Protagonist Therapeutics, Tel: +1.510.474.0170 ext. 300, Email: j.taylor@ptgx-inc.com; Rebecca John, Solebury Trout, Tel: +1.646.378.2935, Email: rjohn@soleburytrout.com