0001193125-22-280741.txt : 20221109 0001193125-22-280741.hdr.sgml : 20221109 20221109080603 ACCESSION NUMBER: 0001193125-22-280741 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20221108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221109 DATE AS OF CHANGE: 20221109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Phathom Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001783183 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 824151574 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39094 FILM NUMBER: 221370740 BUSINESS ADDRESS: STREET 1: 100 CAMPUS DRIVE, STREET 2: SUITE 102 CITY: FLORHAM PARK STATE: NJ ZIP: 07932 BUSINESS PHONE: (877) 742-8466 MAIL ADDRESS: STREET 1: 100 CAMPUS DRIVE, STREET 2: SUITE 102 CITY: FLORHAM PARK STATE: NJ ZIP: 07932 8-K 1 d412146d8k.htm 8-K 8-K
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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): November 8, 2022

 

 

PHATHOM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39094   82-4151574

(State or other jurisdiction of

incorporation or organization)

  

(Commission

File Number)

  

(I.R.S. Employer

Identification No.)

100 Campus Drive, Suite 102

Florham Park, New Jersey 07932

(Address of principal executive offices) (Zip Code)

(877) 742-8466

(Registrant’s telephone number, include area code)

N/A

(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 $0.0001 per share   PHAT   The Nasdaq Global Select Market

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 November 8, 2022, Phathom Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

   

Description

99.1    Press Release issued on November 8, 2022
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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.

 

    PHATHOM PHARMACEUTICALS, INC.
Date: November 9, 2022     By:  

/s/ Larry Miller

      Larry Miller
      General Counsel and Secretary
 EX-99.1 2 d412146dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Phathom Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Updates

 

  •  

Patient enrollment completed for Phase 3 non-erosive gastroesophageal reflux disease (NERD) daily dosing trial with topline data for primary endpoint expected in Q1 2023

 

  •  

Obtained commitment for up to an additional $40 million under revenue interest financing agreement; total financing potentially available increased to $300 million

 

  •  

Commercial launches in H. pylori, and Erosive Esophagitis (EE), if approved, anticipated in Q1 2023

FLORHAM PARK, N.J., November 8, 2022 — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the third quarter of 2022 and provided recent business updates.

“Phathom continued to make significant progress in the third quarter, including completing enrollment in our Phase 3 NERD daily dosing trial, and increasing the total amount potentially available under our royalty financing agreement to $300 million which will further fund our planned product launches and future vonoprazan development programs,” said Terrie Curran, President and Chief Executive Officer of Phathom. “Over the last several months we have developed and validated test methods for detecting the nitrosamine impurity discovered at trace levels in our drug product as reported in August and are in discussions with the FDA on our control limits in advance of bringing our novel products to market.” In addition, we are pleased with the progress our commercial and market access teams have made over the last quarter preparing for the anticipated first quarter 2023 launches of VOQUEZNA™ TRIPLE PAK™ and VOQUEZNA™ DUAL PAK™ as well as, if approved, VOQUEZNA™ tablets for EE.”

Third Quarter and Recent Business Updates:

 

  •  

On November 1, 2022, Phathom announced the placement of the remaining $40 million in non-dilutive capital under its up to $300 million revenue interest financing agreement. This commitment provides an additional $15 million upon FDA approval of vonoprazan for treatment of EE and $25 million for achievement of a sales milestone.

 

  •  

On October 24, 2022, the Company announced it had completed enrollment in its PHALCON-NERD Daily Dosing Phase 3 trial of vonoprazan in non-erosive gastroesophageal reflux disease (NERD). The trial enrolled a total of 776 patients with NERD at study sites across the United States. Topline data for the primary endpoint is expected in the first quarter of 2023 with full trial results available in late 2023. If successful, the Company believes that the trial will form the basis of a supplemental New Drug Application (sNDA) for vonoprazan as once daily therapy for the treatment of symptomatic NERD in adults with a planned submission in 2023.

 

  •  

During the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, held October 21-26, 2022, in Charlotte, NC, Phathom presented new data on vonoprazan for the treatment of gastric acid-related disorders, including the results of an exploratory endpoint in the Phase 2 PHALCON-NERD trial evaluating vonoprazan as an investigational on-demand treatment. These results demonstrated higher rates of complete and sustained relief of episodic heartburn for all vonoprazan doses versus placebo within one hour, and maintained for 24 hours, after taking study drug. Additional findings from a study examining the pharmacodynamic and pharmacokinetic effects of vonoprazan on intragastric acidity were also presented and demonstrated vonoprazan provided consistent, dose-dependent acid suppression.

  •  

On October 10, 2022, Phathom announced it entered into a long-term commercial supply agreement with Evonik to produce vonoprazan at its FDA-inspected manufacturing sites in Tippecanoe, Indiana, and Dossenheim, Germany.

 

  •  

Phathom announced the strengthening of its company leadership with the appointment of James Topper, M.D., Ph.D., to its Board of Directors. Dr. Topper currently serves as a Managing Partner at Frazier Life Sciences and is also the Chairman and Chief Executive Officer of Frazier Lifesciences Acquisition Corporation (Nasdaq: FLAC). Dr. Topper has rejoined Phathom’s Board having served as a Phathom Board member from its creation in January 2018 until May 2021.

Third Quarter 2022 Financial Results:

 

  •  

Net loss for the third quarter ended September 30, 2022, was $51.1 million, compared to $36.7 million for third quarter 2021. Third quarter 2022 net loss included a non-cash charge related to stock-based compensation of $5.8 million compared to the third quarter of 2021 non-cash charge related to stock-based compensation of $4.4 million.

 

  •  

Research and development expenses for the third quarter were $19.0 million, an increase of $2.4 million compared to $16.6 million for third quarter 2021. The increase was a result of increased clinical trial costs related to the development of vonoprazan including activity relating to the ongoing Phase 3 NERD daily dosing trial.

 

  •  

General and administrative expenses for the third quarter were $23.5 million, an increase of $7.0 million compared to $16.5 million for third quarter 2021 primarily due to the ongoing buildout of commercial infrastructure in support of the planned first quarter 2023 U.S. launch of VOQUEZNA TRIPLE PAK and DUAL PAK, and, if approved, VOQUEZNA tablets for EE.

 

  •  

As of September 30, 2022, cash and cash equivalents were $196.8 million plus an additional $100 million available under the Company’s term loan with Hercules Capital.

 

  •  

Based on its current operating plan, including the anticipated funds available under its existing term loan and royalty interest financing, the Company believes it has sufficient capital to fund operations through 2024.

About Phathom Pharmaceuticals, Inc.

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Vonoprazan-based regimens are approved in the U.S. as part of a co-packaged product in combination with antibiotics for the treatment of H. pylori infection in adults, marketed as VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin). Phathom has a New Drug Application under review by the FDA for vonoprazan in erosive esophagitis (EE) and is studying the use of vonoprazan for the treatment of non-erosive reflux disease (NERD). For more information about Phathom, visit the Company’s website at www.phathompharma.com and follow the Company on LinkedIn and Twitter.

Forward Looking Statements

Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected PDUFA target action date and potential approval of our EE NDA; our plans to launch vonoprazan for our H. pylori and EE indications and the timing thereof; the expected timing of topline data for the NERD daily dosing Phase 3 trial; and our plans to address the trace levels of a nitrosamine impurity observed in vonoprazan drug product for VOQUEZNA DUAL PAK and TRIPLE PAK and to obtain FDA approval to enable commercial launch of these products as well as VOQUEZNA, if approved, for EE. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the FDA may disagree that the existing safety and efficacy data is sufficient to approve the EE NDA, including as a result of the trace levels of a nitrosamine impurity observed in commercial batches of vonoprazan drug product for VOQUEZNA DUAL PAK and TRIPLE PAK; the potential for the FDA to delay the PDUFA target action date related to the EE NDA due to the FDA’s internal resource constraints or other reasons; the inherent risks of clinical development of vonoprazan; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Phathom’s ability to successfully address the formation of nitrosamine impurities in commercial batches of vonoprazan drug product and gaining FDA approval of any such resolution including the applicable acceptable daily intake limit; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to access additional capital under its term loan facility and royalty interest finance agreements is subject to certain conditions; Phathom’s ability to obtain and maintain intellectual property protection for vonoprazan; Phathom’s ability to comply with its license agreement with Takeda; Phathom’s ability to maintain undisrupted business operations due to the ongoing spread of the COVID-19 coronavirus, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain, and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Media and Investor Contact:

Nick Benedetto

1-877-742-8466

media@phathompharma.com

ir@phathompharma.com

Selected Condensed Balance Sheets

(Unaudited)

(in thousands)

 

     September 30,
2022		     December 31,
2021		  

Assets

     

Cash and cash equivalents

    $ 196,838     $ 183,259  

Total assets

    $ 201,931     $ 189,431  

Total liabilities

    $ 228,354     $ 117,275  

Total stockholders’ equity (deficit)

    $ (26,423 )    $ 72,156  

PHATHOM PHARMACEUTICALS, INC.

Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share amounts)

 

     Three Months Ended
September 30,		     Nine Months Ended
September 30,		  
     2022     2021     2022     2021  
                          

Operating expenses:

         

Research and development (includes related party amounts of $77, $849, $1,800, and $2,695, respectively)

    $ 19,020     $ 16,608     $ 55,495     $ 58,786  

General and administrative (includes related party amounts of $0, $0, $0, and $16, respectively)

      23,509       16,529       70,303       43,254  
  

 

 

    

 

 

    

 

 

    

 

 

  

Total operating expenses

      42,529       33,137       125,798       102,040  
  

 

 

    

 

 

    

 

 

    

 

 

  

Loss from operations

      (42,529 )      (33,137 )      (125,798 )      (102,040 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Other income (expense):

         

Interest income

      726       8       845       35  

Interest expense

      (9,277 )      (1,485 )      (17,703 )      (4,013 ) 

Other expense

      (11 )      (2,048 )      (20 )      (2,039 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Total other expense

      (8,562 )      (3,525 )      (16,878 )      (6,017 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss and comprehensive loss

    $ (51,091 )    $ (36,662 )    $ (142,676 )    $ (108,057 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss per share, basic and diluted

    $ (1.32 )    $ (0.98 )    $ (3.72 )    $ (2.94 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Weighted-average shares of common stock outstanding, basic and diluted

      38,820,266       37,299,351       38,379,292       36,748,492  
  

 

 

    

 

 

    

 

 

    

 

 

  

© 2022 Phathom Pharmaceuticals. All rights reserved.

VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks or trademarks of Phathom Pharmaceuticals, Inc.

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