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Phathom Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Corporate Update

November 25, 2019 GMT

BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Nov 25, 2019--

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today its results for the third quarter ended September 30, 2019 and provided an update on recent corporate developments.

“Phathom has made tremendous progress in the six months since licensing the rights to vonoprazan, our foundational product candidate for the treatment of acid-related disorders,” said David Socks, President and CEO of Phathom. “In that time, we met with and received positive feedback from the FDA and EMA, received IND clearance as well as QIDP and Fast Track status from the FDA, and completed our IPO with gross proceeds of $209.0 million. We also remain on track to initiate PHALCON-EE, our Phase 3 clinical trial of vonoprazan for both the healing and maintenance of healing of erosive esophagitis as well as the relief of heartburn, and PHALCON-HP, our Phase 3 clinical trial of vonoprazan in combination with antibiotics for the treatment of H. pylori infection, before year end.”

Third-Quarter 2019 Business Highlights:

Recent Developments:

Third Quarter and Year-to-Date 2019 Financial Results:

About Vonoprazan

Vonoprazan is an 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 rapid, potent, and durable anti-secretory effects and has demonstrated clinical benefits over standard of care treatments 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. Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 17 Phase 3 trials for vonorpazan and received marketing approval in Japan and eight other countries in Asia and Latin America.

About Phathom

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has 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.

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 timing of the initiation of Phase 3 clinical trials of vonoprazan before the end of 2019; and the potential to receive regulatory and exclusivity benefits as a result of QIDP and Fast Track designations. 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: potential delays in the commencement, enrollment and completion of clinical trials; our dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of our clinical trials of vonoprazan, and the results of prior clinical trials and other investigator-initiated clinical trials of vonoprazan are not necessarily predictive of our future results and the FDA and comparable foreign regulatory authorities may not accept the data from such prior trials to support approval; 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; QIDP and Fast Track designations may not actually lead to a faster development or regulatory review or extended exclusivity, and would not assure FDA approval of vonoprazan; our ability to obtain and maintain intellectual property protection for vonoprazan; our ability to comply with our license agreement with Takeda; 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 Registration Statement on Form S-1 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.

TABLES FOLLOW

PHATHOM PHARMACEUTICALS, INC.

Combined Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except per share data)

 

Three Months Ended
September 30,

Nine Months Ended
September 30,

2019

 

2018

 

2019

 

2018

(unaudited)

(unaudited)

Operating expenses:

Research and development

$ 4,469

$ 6

$ 7,670

$ 6

In-process research and development

78,897

General and administrative

1,813

262

3,955

768

Total operating expenses

6,282

268

90,522

774

 

Loss from operations

(6,282)

(268)

(90,522)

(774)

 

Other income (expense):

Interest income

429

530

Interest expense

(1,990)

(4)

(3,138)

(8)

Change in fair value of warrant liabilities

(57,776)

(59,060)

Change in fair value of convertible promissory notes

(2,486)

(18)

(4,928)

(22)

Other income (expense)

(7)

(7)

Total other income (expense)

(61,830)

(22)

(66,603)

(30)

Net loss

$ (68,112)

$ (290)

$(157,125)

$ (804)

Net loss per share, basic and diluted

$ (9.30)

$ (0.04)

$ (22.87)

$ (0.14)

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

7,326,090

6,760,334

6,871,471

5,812,860

PHATHOM PHARMACEUTICALS, INC.

Combined Balance Sheets

(Unaudited)

(in thousands)

 

 

 

September 30,

2019

 

 

December 31,

2018

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

74,484

 

 

$

879

 

Prepaid expenses and other current assets

 

 

3,169

 

 

 

23

 

Total current assets

 

 

77,653

 

 

 

902

 

Property, plant and equipment, net

 

 

40

 

 

 

 

Other assets

 

 

2,013

 

 

 

 

Total assets

 

$

79,706

 

 

$

902

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Deficit

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

439

 

 

$

55

 

Accrued expenses

 

 

2,120

 

 

 

170

 

Accrued interest

 

 

2,332

 

 

 

13

 

Convertible promissory notes payable at fair value

 

 

95,229

 

 

 

1,950

 

Warrant liabilities

 

 

107,373

 

 

 

 

Total current liabilities

 

 

207,493

 

 

 

2,188

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of discount

 

 

22,611

 

 

 

 

Other long-term liabilities

 

 

2,063

 

 

 

 

Total liabilities

 

 

232,167

 

 

 

2,188

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Common stock

 

 

 

 

 

 

Additional paid-in capital

 

 

5,952

 

 

 

2

 

Accumulated deficit

 

 

(158,413

)

 

 

(1,288

)

Total stockholders’ deficit

 

 

(152,461

)

 

 

(1,286

)

Total liabilities and stockholders’ deficit

 

$

79,706

 

 

$

902

 

 

View source version on businesswire.com:https://www.businesswire.com/news/home/20191125005187/en/

CONTACT: David Socks

650-325-5156

info@phathompharma.com

Media:

Mike Beyer

Sam Brown Inc. Healthcare Communications

312-961-2502

mikebeyer@sambrown.com

Investors:

Patti Bank

Westwicke Partners

415-513-1284

patti.bank@westwicke.com

KEYWORD: ILLINOIS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH

SOURCE: Phathom Pharmaceuticals, Inc.

Copyright Business Wire 2019.

PUB: 11/25/2019 08:30 AM/DISC: 11/25/2019 08:30 AM

http://www.businesswire.com/news/home/20191125005187/en