# EDGAR Filing Document

**Accession Number:** 0001377121
**File Stem:** 0001104659-23-032774
**Filing Date:** 2023-3
**Character Count:** 21020
**Document Hash:** 95b698f6752c3b3d9868ffe9a79839b1
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-032774.hdr.sgml**: 20230315

**ACCESSION NUMBER**: 0001104659-23-032774

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230315

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230315

**DATE AS OF CHANGE**: 20230315

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Protagonist Therapeutics, Inc
- **CENTRAL INDEX KEY:** 0001377121
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 980505495
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37852
- **FILM NUMBER:** 23735274

**BUSINESS ADDRESS:**
- **STREET 1:** 7707 GATEWAY BLVD., SUITE 140
- **CITY:** NEWARK
- **STATE:** CA
- **ZIP:** 94560-1160
- **BUSINESS PHONE:** (510) 474-0170

**MAIL ADDRESS:**
- **STREET 1:** 7707 GATEWAY BLVD., SUITE 140
- **CITY:** NEWARK
- **STATE:** CA
- **ZIP:** 94560-1160

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Protagonist Therapeutics Inc
- **DATE OF NAME CHANGE:** 20130605

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Protagonist Inc
- **DATE OF NAME CHANGE:** 20061002

?xml version="1.0" encoding="utf-8"?

**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): **March 15, 2023**

**PROTAGONIST THERAPEUTICS, INC.**

(Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-37852** | **98-0505495** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (IRS Employer<br> 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<br> 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 ◻

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. ◻

**Item 2.02. Results of Operations and Financial Condition.**

On March 15, 2023, Protagonist Therapeutics, Inc. reported its financial results for the fourth quarter and full year ended December 31, 2022. A copy of the press release titled "Protagonist Therapeutics Reports Fourth Quarter and Full Year 2022 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

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm239503d1_ex99-1.htm) | [Press release, dated March 15, 2023, titled "Protagonist Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update."](tm239503d1_ex99-1.htm) |
| 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.** | **Protagonist Therapeutics, Inc.** |
| Dated: March 15, 2023 |  |  |
|  | By: | /s/ Asif Ali |
|  |  | Asif Ali |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Protagonist Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update**

*Positive results from the Phase 2b FRONTIER 1 study of JNJ-2113 (formerly PN-235) in moderate-to-severe psoriasis, paving a path forward for initiation of a Phase 3 pivotal study*

 

*Highly statistically significant results from the randomized withdrawal portion of the REVIVE study of rusfertide in polycythemia vera, achieving its primary endpoint of proportion of responders on rusfertide versus placebo (p=0.0003)*

 

**NEWARK, Calif., March 15, 2023** – Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.

"The positive FRONTIER 1 JNJ-2113 (PN-235) data recently reported represents a scientific breakthrough with the potential to transform the treatment landscape for moderate-to-severe plaque psoriasis with oral targeted therapy. We look forward to in-depth presentations of JNJ-2113 pre-clinical and Phase 1 and Phase 2 clinical studies at medical conferences beginning in the second quarter of 2023," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "In addition, we are extremely pleased to have announced this morning the positive results from the randomized withdrawal part of the REVIVE study of rusfertide in polycythemia vera (PV). The study met its primary endpoint, with a statistically significant higher number of responders on rusfertide versus placebo (p=0.0003). Improvements in symptoms were observed, and rusfertide was generally well tolerated in the overall study."

Dr. Patel continued, "These positive results from the Phase 2 FRONTIER 1 and REVIVE studies, of JNJ-2113 and rusfertide, respectively, are testaments to the promise of our proprietary platform as well as the expertise, experience and commitment of the Protagonist team. We are focused on enrolling patients globally in the Phase 3 VERIFY study of rusfertide in PV, and we are diligently preparing for the pre-commercial launch-related activities for rusfertide.

"Meanwhile, our discovery engine remains prolific. We are evaluating pre-clinical compounds with the potential to have impact in areas of high unmet medical need, and we are specifically advancing efforts in the oral hepcidin mimetic program. With two assets in late-stage development, Protagonist is now closer than ever to bringing transformative new therapies to patients. As an industry leader in the discovery and development of peptide therapeutics, we hold a unique set of capabilities that position our Company for value creation over the long run," Patel said.

**Fourth Quarter 2022 Recent Developments and Upcoming Milestones**

*Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders*

· The
 double-blind, placebo-controlled, 12-week randomized withdrawal portion of the REVIVE study
 met its primary endpoint, phlebotomy eligibility, with subjects randomized to rusfertide
 demonstrating a highly statistically significant (p=0.0003) proportion of responders compared
 to placebo. A study subject was defined as a responder if the subject completed 12 weeks
 of double-blind treatment while maintaining hematocrit control without phlebotomy eligibility
 and without phlebotomy. During the 12 weeks of the blinded randomized withdrawal, only 2
 of 26 subjects on rusfertide were phlebotomized, keeping 92.3% of patients phlebotomy free
 in the treatment arm.

· In
 patients with moderate or severe Myeloproliferative Neoplasm-Symptom Assessment Form (MPN-SAF)
 symptom scores at baseline, the change from baseline was statistically significant in fatigue,
 problems with concentration, inactivity and itching during the 28-week open label Part 1
 of the study. Meaningful comparison of symptom assessments in Part 2 are not possible since
 a majority of subjects randomized to placebo discontinued prior to the 12-week assessment
 of MPN-SAF symptoms.

· Rusfertide
 was well tolerated, with localized injection site reactions comprising the majority of reported
 adverse events. No new safety signals were observed in these data, following presentation
 of safety data from the REVIVE study at the American Society of Hematology (ASH) December
 2022.

· For
 PV, Rusfertide has received FDA and EU orphan designation and FDA fast track designation.

*JNJ-2113 (formerly PN-235): Oral IL-23 Receptor Antagonist*

 

&nbsp;&nbsp;&nbsp;&nbsp;· The
 Company announced positive topline results from its collaboration with Janssen Biotech, Inc.,
 one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in the FRONTIER 1 Phase
 2b clinical trial evaluating the oral Interleukin-23 receptor (IL-23R) antagonist peptide
 JNJ-2113 in patients with moderate-to-severe plaque psoriasis.

&nbsp;&nbsp;&nbsp;&nbsp;· Data
 from the 255-patient study showed that JNJ-2113 achieved the study's primary efficacy
 endpoint, with a statistically significant greater proportion of patients who received JNJ-2113
 achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and
 Severity Index) responses compared to placebo at Week 16 in all five treatment groups. A
 clear dose response was observed across an eight-fold dose range.

&nbsp;&nbsp;&nbsp;&nbsp;· All
 treatments were well tolerated, with no meaningful difference in frequency of adverse events
 across treatment groups versus placebo.

&nbsp;&nbsp;&nbsp;&nbsp;· Data
 from various pre-clinical and clinical studies on JNJ-2113 will be presented at medical conferences
 beginning in the second quarter of 2023.

&nbsp;&nbsp;&nbsp;&nbsp;· Phase
 1 and preclinical data of JNJ-2113 will be presented on May 12, 2023 at the International
 Societies for Investigative Dermatology Meeting 2023. More information on this presentation,
 entitled, "First-in-class oral peptide systemically targeting the IL-23 pathway,"
 is available on the ISID 2023 website at isid2023.org.

**Fourth Quarter 2022 Financial Results:** 

&nbsp;&nbsp;&nbsp;&nbsp;· **Cash, Cash Equivalents and Marketable Securities**: Cash, cash equivalents and marketable securities
 as of December 31, 2022 were $237.4 million. The Company expects current cash, cash equivalents
 and marketable securities to be sufficient to fund its planned operating and capital expenditures
 through the end of 2024.

&nbsp;&nbsp;&nbsp;&nbsp;· **License and Collaboration Revenue**: License and collaboration revenue for the fourth quarter and
 full year 2022 were zero and $26.6 million, respectively, as compared to $8.6 million and
 $27.4 million for the same periods of 2021. The decreases in revenue from prior year periods
 were primarily due to a decrease in the level of services the Company provided under the
 Janssen license and collaboration agreement. The Company completed its performance obligation
 pursuant to the collaboration as of June 30, 2022.

&nbsp;&nbsp;&nbsp;&nbsp;· **Research and Development ("R&D") Expenses**: R&D expenses for the fourth quarter
 and full year 2022 were $29.9 million and $126.2 million respectively, as compared to $38.4
 million and $126.0 million, respectively, for the same periods of 2021. The decrease in R&D
 expenses from prior year quarter was primarily due to lower PN-943 expenses related to the
 suspension of further program expenditures, a decrease in costs related to the completion
 of JNJ-2113 and PN-232 Phase 1 trials, and a decrease in research and discovery program expenses.

&nbsp;&nbsp;&nbsp;&nbsp;· **General and Administrative ("G&A") Expenses**: G&A expenses for the fourth quarter
 and full year 2022 were $6.6 million and $31.7 million, respectively, as compared to $7.3
 million and $27.2 million for the same periods of 2021. The decrease in G&A expenses
 from prior year quarter was primarily due to a decrease in personnel related expenses during
 the three months ended December 31, 2022. The increase in G&A expenses from prior year
 was primarily due to increases in personnel related expenses, including stock-based compensation
 expense, and other expenses to support Company growth.

&nbsp;&nbsp;&nbsp;&nbsp;· **Net Loss**: Net loss was $34.2 million, or $0.69 per share, for the fourth quarter of 2022
 as compared to a net loss of $36.9 million, or $0.77 per share, for the fourth quarter of
 2021. Net loss was $127.4 million, or $2.60 per share, for the full year 2022, as compared
 to a net loss of $125.6 million, or $2.71, for the full year 2021.

**PROTAGONIST THERAPEUTICS, INC.<br> Condensed Consolidated Statements of Operations**

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

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended** | **Three Months Ended** | **Twelve Months Ended** | **Twelve Months Ended** |
|  | **December 31,** | **December 31,** | **December 31,** | **December 31,** |
|  | **2022** | **2021** | **2022** | **2021** |
| License and collaboration revenue - related party | $— | $8617 | $26581 | $27357 |
| **Operating expenses:** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development <sup>(1)</sup> | 29884 | 38373 | 126215 | 126006 |
| &nbsp;&nbsp;&nbsp;General and administrative <sup>(1)</sup> | 6632 | 7260 | 31739 | 27196 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 36516 | 45633 | 157954 | 153202 |
| Loss from operations | (36516) | (37016) | (131373) | (125845) |
| Interest income | 2251 | 122 | 4060 | 443 |
| Other income (expense), net | 71 | (13) | (80) | (149) |
| Net loss | $(34194) | $(36907) | $(127393) | $(125551) |
| Net loss per share, basic and diluted | $(0.69) | $(0.77) | $(2.60) | $(2.71) |
| Weighted-average shares used to compute net loss per share, basic and diluted | 49262643 | 48154171 | 49042232 | 46322910 |

---

<sup>(1)</sup> Amount includes non-cash stock-based compensation expense.

**PROTAGONIST THERAPEUTICS, INC.<br> Stock-based Compensation**

**(In thousands)**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended** | **Three Months Ended** | **Twelve Months Ended** | **Twelve Months Ended** |
|  | **December 31,** | **December 31,** | **December 31,** | **December 31,** |
|  | **2022** | **2021** | **2022** | **2021** |
| Research and development | $3429 | $2755 | $14719 | $8996 |
| General and administrative | 2083 | 2269 | 9483 | 7399 |
| Total stock-based compensation expense | $5512 | $5024 | $24202 | $16395 |

---

**PROTAGONIST THERAPEUTICS, INC.<br> Selected Consolidated Balance Sheet Data<br> (In thousands)**

---

| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
| Cash, cash equivalents and marketable securities | $237355 | $326900 |
| Working capital | 211198 | 298720 |
| Total assets | 247928 | 347695 |
| Deferred revenue-related party |  | 1601 |
| Accumulated deficit | (536755) | (409362) |
| Total stockholders' equity | 215608 | 300021 |

---

**About Protagonist**

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 stage of development. The REVIVE study is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.

Positive topline results from the FRONTIER 1 study of JNJ-2113 in moderate-to-severe plaque psoriasis became available in March 2023, with further details to be shared at medical meetings starting in the second quarter of 2023. Advancement of JNJ-2113 into a Phase 3 study and meeting the primary endpoint in that study would qualify Protagonist for milestone payments of $50 million and $115 million, respectively. In total, Protagonist remains eligible for up to $855 million in various milestone payments and tiered royalties based on worldwide net drug sales.

More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at <u>protagonist-inc.com</u>.

**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 expectations regarding the potential benefits of JNJ-2113 and rusfertide, timing of JNJ-2113 clinical trials and potential milestones related to JNJ-2113, and our expected cash runway. 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, delays or difficulties in enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate our compounds or product candidates are unsafe or ineffective, dependence on third parties to conduct clinical studies and manufacture our products, our ability to earn milestone payments under our collaboration agreement with Janssen Biotech, the impact of the current COVID-19 pandemic on our discovery and development efforts, impact of natural disasters and the impact of the ongoing military conflict in Ukraine and Russia on any future studies, 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 most recently filed periodic reports on Form 10-K and Form 10-Q 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.

**Contacts**

Jami Taylor – <u>j.taylor@ptgx-inc.com</u>