EX-99.1 2 d735779dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

NGM Bio Reports Recent Highlights and First Quarter 2019 Financial Results

-Advanced NGM282 into Phase 2b ALPINE 2/3 clinical study in NASH-

-Received $177.8 million in aggregate net proceeds in April from Initial Public Offering

and private placement with Merck-

South San Francisco, CA, May 16, 2019 – NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, today provided a business update and reported first quarter 2019 financial results for the period ending March 31, 2019.

“We’ve had a productive 2019 thus far, making progress on multiple fronts, including the initiation of a Phase 2b clinical trial evaluating NGM282 in patients with non-alcoholic steatohepatitis (NASH) and F2-F3 liver fibrosis,” said David J. Woodhouse, Ph.D., chief executive officer of NGM. “Bolstered by the successful completion of our IPO in April and a strong cash position, we continue to advance our broad clinical and preclinical pipeline of next generation medicines. We look forward to sharing further developments regarding these programs later this year.”

First Quarter 2019 and Recent Highlights

 

   

Completed Initial Public Offering (IPO) and concurrent private placement with Merck. The company’s common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol “NGM” on April 4, 2019. The IPO, priced at a public offering price of $16.00 per share, raised $111.9 million in aggregate net proceeds, including shares sold to the underwriters pursuant to the partial exercise of their overallotment option and after deducting the underwriting discounts and commissions. The company received $65.9 million in additional proceeds from a concurrent private placement of shares of common stock to Merck Sharp & Dohme Corp. (Merck) at the IPO public offering price of $16.00 per share.

 

   

Dosed first patient in Phase 2b ALPINE 2/3 clinical study in NASH patients with F2-F3 fibrosis for NGM282. The Phase 2b ALPINE 2/3 study is expected to enroll approximately 150 patients with biopsy-confirmed NASH and stage F2-F3 liver fibrosis, and will assess the efficacy, safety and tolerability of NGM282 compared to placebo. The primary efficacy objective is to evaluate the treatment effect after 24 weeks of three dose levels of NGM282 (0.3 mg, 1 mg and 3 mg) on liver histology, which is defined as an improvement in liver fibrosis (³ 1 stage change) with no worsening of NASH or a resolution of NASH (defined as a NAFLD activity score for inflammation of 0 or 1 and ballooning score of 0) with no worsening of fibrosis. NGM anticipates announcing preliminary results from this Phase 2b clinical study in 2020.


   

Extended strategic collaboration with Merck. In March, Merck exercised its option to extend its broad, strategic collaboration with NGM for an additional two-year period from March 2020 to March 2022. During the two-year extension period, Merck will continue to fund NGM’s research and development efforts at the same levels as the original collaboration terms and, in lieu of a $20 million extension fee payable to NGM, Merck will make additional payments totaling $20 million in support of NGM’s research and development activities during 2021 and the first quarter of 2022. The companies also announced that Merck will terminate its license to NGM’s growth differentiation factor 15 (GDF15) receptor agonist program, effective May 31, 2019, at which time the program rights will return to NGM. 

 

   

Appointed Hsiao D. Lieu, M.D., as Senior Vice President, Chief Medical Officer. In March, NGM announced the appointment of Hsiao D. Lieu, M.D. as Senior Vice President, Chief Medical Officer. Dr. Lieu most recently served as Vice President of Early Clinical Development at Genentech, where he was responsible for early phase drug development for all non-oncology indications, including ophthalmology, metabolic, neurology and inflammation. Concurrent with Dr. Lieu’s appointment, Alex DePaoli, M.D., who had served as NGM’s founding Chief Medical Officer, transitioned to the role of Senior Vice President, Chief Translational Officer. In this new role, Dr. DePaoli is focused on guiding NGM’s robust discovery portfolio into clinical development.

First Quarter Financial Results

 

   

Related party revenue for the first quarter of 2019 was $25.6 million compared to $18.6 million for the same period in 2018.

 

   

Research and development expenses for the first quarter of 2019 were $29.5 million, as compared to $19.5 million for the same period in 2018. The increase in research and development expense was primarily related to an increase in external research and development expenses associated with the advancement of NGM’s growing pipeline and increased NGM282 program expenses due to the ongoing Phase 2 clinical trials.

 

   

General and administrative expenses for the first quarter 2019 were $5.4 million, as compared to $3.9 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and professional service expenses required to support NGM’s ongoing operations.

 

   

For the first quarter of 2019, NGM reported a net loss of $8.3 million, compared to a net loss of $3.9 million for the same period in 2018.

 

   

Cash, cash equivalents and short-term marketable securities were $193.4 million as of March 31, 2019, which does not include the net proceeds from NGM’s initial public offering and the private placement of shares with Merck, which closed in April, compared to $206.6 million as of December 31, 2018.


About NGM Biopharmaceuticals, Inc.

NGM is a clinical stage biopharmaceutical company focused on developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. The company leverages its biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable it to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. NGM aspires to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit http://www.ngmbio.com for more information.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to NGM’s advancement of its clinical and preclinical pipeline; the timing, enrollment and results of NGM’s clinical trials, including the continued enrollment and announcement of preliminary results of the Phase 2b clinical study of NGM282 in patients with NASH; the safety, tolerability and efficacy of NGM’s product candidates; NGM’s ability to fund its clinical programs and NGM’s financial outlook. Because such statements deal with future events and are based on NGM’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of NGM could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our prospectus dated April 3, 2019, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the SEC’s website at www.sec.gov. Additional information will be made available in NGM’s quarterly report on Form 10-Q for the quarter ended March 31, 2019 and other filings that we make from time to time with the SEC. Except as required by law, NGM assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Investor Contact:

ir@ngmbio.com

Media Contact:

Liz Melone

media@ngmbio.com


NGM Biopharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

 

     Three Months Ended March 31,  
     2019     2018  

Related party revenue

   $ 25,552     $ 18,613  
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     29,527       19,454  

General and administrative

     5,367       3,874  
  

 

 

   

 

 

 

Total operating expenses

     34,894       23,328  
  

 

 

   

 

 

 

Loss from operations

     (9,342     (4,715

Interest income

     1,110       752  

Other income (expense), net

     (36     22  
  

 

 

   

 

 

 

Net loss

   $ (8,268   $ (3,941
  

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (1.21   $ (0.64
  

 

 

   

 

 

 

Weighted average shares used to compute net loss per common share, basic and diluted

     6,812,129       6,127,040  
  

 

 

   

 

 

 


NGM Biopharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except per share amounts)

 

     March 31,     December 31,  
     2019     2018*  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 47,313     $ 56,923  

Short-term marketable securities

     146,126       149,710  

Related party receivable from collaboration

     —         3,669  

Prepaid expenses and other current assets

     5,706       4,255  
  

 

 

   

 

 

 

Total current assets

     199,145       214,557  

Property and equipment, net

     23,319       23,893  

Restricted cash

     2,249       2,249  

Deferred IPO costs

     3,669       2,292  

Other non-current assets

     3,245       3,094  
  

 

 

   

 

 

 

Total assets

   $ 231,627     $ 246,085  
  

 

 

   

 

 

 

Liabilities, convertible preferred stock and stockholders’ deficit

    

Current liabilities:

    

Accounts payable

   $ 4,203     $ 5,775  

Accrued liabilities

     13,916       14,003  

Deferred rent, current

     2,719       2,683  

Deferred revenue, current

     22,041       19,025  
  

 

 

   

 

 

 

Total current liabilities

     42,879       41,486  

Deferred rent, non-current

     11,532       12,221  

Deferred revenue, non-current

     —         3,942  

Early exercise stock option liability

     1,322       1,559  

Convertible preferred stock warrant liability

     —         198  
  

 

 

   

 

 

 

Total liabilities

     55,733       59,406  
  

 

 

   

 

 

 

Commitments and contingencies

    

Convertible preferred stock, $0.001 par value;

     295,072       294,874  

Stockholders’ deficit:

    

Common stock, $0.001 par value;

     7       7  

Additional paid-in capital

     42,477       39,258  

Accumulated other comprehensive loss

     (45     (267

Accumulated deficit

     (161,617     (147,193
  

 

 

   

 

 

 

Total deficit

     (119,178     (108,195
  

 

 

   

 

 

 

Total liabilities, convertible preferred stock and stockholders’ deficit

   $ 231,627     $ 246,085  
  

 

 

   

 

 

 

 

*

The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date.