false 0001783183 0001783183 2021-11-08 2021-11-08





Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 8, 2021




(Exact name of registrant as specified in its charter)




Delaware   001-39094   82-4151574

(State or other jurisdiction of

incorporation or organization)



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)


(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





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, 2021, Phathom Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2021. 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




99.1    Press Release issued on November 8, 2021
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


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.


Date: November 8, 2021     By:  

/s/ Larry Miller

      Larry Miller
      General Counsel and Secretary

Exhibit 99.1

Phathom Pharmaceuticals Reports Third Quarter 2021 Results and Provides Key Clinical, Regulatory, and Business Updates



Two New Drug Applications (NDAs) for vonoprazan-based treatment regimens for H. pylori infection were accepted for filing by FDA with six-month Priority Review granted; PDUFA target action date of May 3, 2022



U.S. launch for both vonoprazan-based treatment regimens for H. pylori anticipated in the second half of 2022, if approved



Positive Phase 3 trial results for vonoprazan in erosive esophagitis (EE) reported in October 2021; NDA submission targeted for the first quarter of 2022

Florham Park, N.J., November 08, 2021 – Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the third quarter of 2021 and provided updates regarding recent clinical, regulatory, and business progress.

“Phathom continued its strong execution through the third quarter of 2021, delivering impressive topline results from our pivotal Phase 3 PHALCON-EE study. The PHALCON-EE data adds to our excitement about vonoprazan’s potential to satisfy large unmet patient needs in the U.S. and European erosive esophagitis market,” said Terrie Curran, Phathom’s President and Chief Executive Officer. “With the recent acceptance of both NDAs for vonoprazan-based treatments in H. pylori, and the planned submission of an NDA for vonoprazan in EE in the first quarter of 2022, we are enthusiastic about vonoprazan’s potential to offer a novel treatment option to address the significant unmet needs that exist for so many patients across these prevalent acid-related disorders.”

Clinical and Regulatory Updates:



The U.S. Food and Drug Administration (FDA) accepted NDAs for two convenience packs containing vonoprazan-based treatment regimens for adults with H. pylori infection: vonoprazan in combination with amoxicillin and clarithromycin (“vonoprazan triple therapy”) and vonoprazan in combination with amoxicillin (“vonoprazan dual therapy”). The NDAs were granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target action date of May 3, 2022. Phathom submitted the NDAs to the FDA on September 3, 2021. The FDA previously designated vonoprazan dual and triple therapy as qualified infectious disease products (QIDPs) which, if approved, will provide vonoprazan five additional years of regulatory exclusivity.



If approved, the U.S. commercial launch for vonoprazan dual and triple therapy is anticipated in the second half of 2022.



Vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal Phase 3 trial evaluating vonoprazan for the healing and maintenance of healing of erosive esophagitis. Based on these results, Phathom expects to submit an NDA in the first quarter of 2022 seeking the following indications for vonoprazan: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn.



Topline results from the Phase 2 PHALCON-NERD on-demand trial evaluating various doses of vonoprazan as an on-demand therapy for patients with non-erosive reflux disease are expected in the first quarter of 2022.

Recent Business and Financial Updates:



On September 17, 2021, Phathom secured an up to $200 million term loan facility from Hercules Capital (Loan Agreement). One-hundred million dollars were drawn at closing and an additional $50 million became available upon the receipt of positive topline results in PHALCON-EE. The final $50 million tranche will become available upon the occurrence of both FDA approval of a vonoprazan-based regimen for the treatment of H. pylori, and FDA acceptance of filing of an NDA for vonoprazan for the treatment of erosive esophagitis.

Third Quarter 2021 Financial Results:



Third quarter 2021 net loss was $36.7 million compared to $34.1 million for the third quarter of 2020.



Third quarter 2021 net loss included a non-cash charge related to stock-based compensation of $4.4 million compared to the third quarter of 2020 non-cash charge related to stock-based compensation of $2.1 million.



Third quarter 2021 research and development expenses decreased to $16.6 million compared to $25.8 million for the third quarter 2020 due to lower clinical trial costs, partially offset by higher regulatory and personnel-related expenses.



Third quarter 2021 general and administrative expenses increased to $16.5 million compared to $7.1 million for the third quarter of 2020 due to the ongoing buildout of administrative and commercial functions.



Third quarter 2021 other expenses increased by $2.3 million compared to the third quarter of 2020 due to a $2.0 million charge related to the early extinguishment of Phathom’s previous debt facility replaced by the Loan Agreement.



As of September 30, 2021, cash and cash equivalents were $224.6 million. Cash and cash equivalents combined with the future drawdown of the remaining $100 million under the Loan Agreement are expected to be sufficient to meet anticipated cash requirements into mid-2023 based on current operating plans.

About Vonoprazan

Vonoprazan is an investigational, oral small molecule potassium-competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan has shown the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The U.S. FDA has awarded qualified infection disease product (QIDP) status and granted Fast Track designation to vonoprazan in combination with both amoxicillin and clarithromycin and with amoxicillin alone for the treatment of H. pylori infection. In November 2021, the FDA accepted for filing two new drug applications for vonoprazan-based regimens for the treatment of H. pylori infection. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan, Russia, and numerous other countries in Asia and Latin America.

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 novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. 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

The Company 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 availability of topline results from the PHALCON-NERD on demand clinical trial, the expected submission of an NDA for the healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn, the expected approval of NDAs for vonoprazan-based treatments for the treatment of H. pylori infection, and the Company’s ability to access additional capital under the Loan Agreement. The inclusion of forward-looking statements should not be regarded as a representation by the Company 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 the Company’s business, including, without limitation: reported top-line data is based on preliminary analysis of key efficacy and safety data is subject to more audit and verification procedures that could result in material changes in the final data; the Company may experience delays submitting an NDA including in the event that the FDA does not agree with the Company’s interpretation of the data or feedback from the FDA that may be inconsistent with feedback received at prior meetings with the FDA; Phathom’s ability to access additional capital under the Loan Agreement is subject to certain conditions including verification by the lender that the clinical milestone has been met; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; 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; previously granted QIDP and Fast Track designations may be withdrawn or not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; the Company’s ability to obtain and maintain intellectual property protection for vonoprazan; the Company’s ability to comply with its license agreement with Takeda; the Company’s ability to maintain undisrupted business operations due to the ongoing presence 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 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 the Company 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 Contact:

Nick Benedetto



Investor Contact:

Joe Hand




Balance Sheets


(in thousands, except share and par value amounts)


     September 30,
    December 31,



Current assets:


Cash and cash equivalents

   $ 224,618     $ 287,496  

Prepaid expenses and other current assets (including related party amounts of $0 and $82, respectively)

     695       3,872  







Total current assets

     225,313       291,368  

Property, plant and equipment, net

     692       986  

Operating lease right-of-use assets

     2,031       2,373  

Other long-term assets

     341       384  







Total assets

   $ 228,377     $ 295,111  







Liabilities and Stockholders’ Equity


Current liabilities:


Accounts payable (including related party amounts of $311 and $173, respectively)

   $ 5,582     $ 16,782  

Accrued clinical trial expenses

     10,491       19,997  

Accrued expenses (including related party amounts of $1,847 and $734, respectively)

     11,040       10,606  

Accrued interest

     214       312  

Current portion of long-term debt


Operating lease liabilities, current

     484       474  







Total current liabilities

     27,811       55,524  

Long-term debt, net of discount

     88,305       39,634  

Operating lease liabilities

     1,280       1,557  

Other long-term liabilities

     7,500       4,125  







Total liabilities

     124,896       100,840  







Stockholders’ equity:


Preferred stock, $0.0001 par value; authorized shares—40,000,000 at September 30, 2021 and December 31, 2020 ; no shares issued and outstanding at September 30, 2021 and December 31, 2020

     —         —    

Common stock, $0.0001 par value; authorized shares — 400,000,000; issued shares — 31,414,827 and 31,262,769 at September 30, 2021 and December 31, 2020, respectively; outstanding shares — 30,047,428 and 28,516,010 at September 30, 2021 and December 31, 2020, respectively

     3       3  

Additional paid-in capital

     597,022       579,755  

Accumulated deficit

     (493,544     (385,487







Total stockholders’ equity

     103,481       194,271  







Total liabilities and stockholders’ equity

   $ 228,377     $ 295,111  








Statements of Operations and Comprehensive Loss


(in thousands, except share and per share amounts)


     Three Months Ended
September 30,
    Nine Months Ended
September 30,
     2021     2020     2021     2020  

Operating expenses:


Research and development (includes related party amounts of $849, $1,023, $2,695, and $1,676, respectively)

   $ 16,608     $ 25,770     $ 58,786     $ 56,494  

General and administrative (includes related party amounts of $0, $62, $16, and $139, respectively)

     16,529       7,060       43,254       16,732  













Total operating expenses

     33,137       32,830       102,040       73,226  













Loss from operations

     (33,137     (32,830     (102,040     (73,226













Other income (expense):


Interest income

     8       15       35       1,075  

Interest expense

     (1,485     (1,286     (4,013     (3,286

Change in fair value of warrant liabilities

     —         —         —         95  

Other income (expense)

     (2,048     (4     (2,039     (5













Total other income (expense)

     (3,525     (1,275     (6,017     (2,121













Net loss and comprehensive loss

   $ (36,662   $ (34,105   $ (108,057   $ (75,347













Net loss per share, basic and diluted

   $ (0.98   $ (1.02   $ (2.94   $ (2.29













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

     37,299,351       33,366,237       36,748,492       32,946,128