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): May 13, 2020

 

NGM Biopharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

(650) 243-5555

(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 (see General Instructions A.2. below):

 

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

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.  ☐

 

 

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On May 13, 2020, NGM Biopharmaceuticals, Inc. provided a business update and reported its financial results for the quarter ended March 31, 2020. A copy of the press release titled “NGM Bio Provides Business Update and Reports First Quarter 2020 Financial Results,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.

 

 

 

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 that 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 NGM Biopharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Exhibit 99.1

 

 

NGM Bio Provides Business Update and Reports First Quarter 2020 Financial Results

-- Initiated Phase 2b ALPINE 4 clinical study of aldafermin (formerly NGM282) in

non-alcoholic steatohepatitis (NASH) patients with compensated cirrhosis (F4 fibrosis) --

 

-- Continuing enrollment in Phase 2b ALPINE 2/3 clinical study of aldafermin in NASH patients with

F2-F3 fibrosis; topline data readout still targeted for first half of 2021 --

 

-- Sustaining progress across broad pipeline, which includes six clinical-stage products targeting

cardio-metabolic and liver disease, ophthalmic disease and cancer --

-- Maintained strong balance sheet, with $328.5 million in cash, cash equivalents

and marketable securities as of March 31, 2020 --

South San Francisco, CA, May 13, 2020 – NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on developing transformative therapeutics for patients, today provided a business update and reported financial results for the period ending March 31, 2020.

“In the first quarter of 2020, we demonstrated strong execution across our broad pipeline in multiple therapeutic areas. As we continue to navigate the ever-evolving COVID-19 situation, we have been fortunate to continue to move forward with our programs, most notably with the initiation of our Phase 2b ALPINE 4 study of aldafermin in patients with compensated cirrhosis due to NASH, a very sick patient population for which there is no currently available treatment other than liver transplant,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. “As previously announced, in the first quarter of 2020, we also initiated a Phase 1a/1b clinical study for NGM120 as a potential treatment for cancer and cancer anorexia/cachexia syndrome, or CACS, and a Phase 1 clinical study for NGM395 as a potential treatment for metabolic disease, bringing us to a total of six product candidates now in clinical development. As we advance our clinical programs during these uncertain and unsettling times, the safety and well-being of patients, healthcare workers and our employees remain our top priority. We are closely monitoring the impact of COVID-19 on our organization and business operations and, like others in our industry, are managing multiple challenges to mitigate disruptions in our ongoing and planned trials in order to remain on track with our development timelines. The high unmet medical needs targeted by each of our development programs provide strong motivation for us to remain focused on execution across our pipeline.”

Throughout the unfolding COVID-19 situation, NGM has worked proactively to establish policies that are designed to enable the company to operate safely, efficiently and productively, preserving mission-critical functions necessary to advance key research and development activities while safeguarding the well-being of patients, study investigators, clinical research staff and NGM employees. For patients already enrolled in NGM clinical trials, the company is working closely with investigators and site staff to continue treatment in compliance with study protocols and to uphold trial integrity, while observing government and institutional guidelines. NGM is continuing to evaluate site initiations and patient enrollment on a case-by-case and patient-by-patient basis in close coordination with investigators and site staff. Some sites, both within and outside of the United States, continue to screen patients for studies, and new patients are being enrolled when appropriate. These internal and external efforts have allowed NGM to continue progress across its clinical development programs. While NGM has experienced a slower pace of site initiation and trial enrollment than originally anticipated in certain of its clinical studies, the impact of the COVID-19 pandemic, to date, has not resulted in a significant impact to the company’s development timelines.

 

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“At this time, we remain on track with all previously provided clinical trial timing guidance and will continue to monitor screening, enrollment and site initiations across our pipeline to understand any potential future impact on timing,” said Dr. Woodhouse. “I admire and am extremely grateful for the dedication and agility of our team, the ongoing commitment of study investigators and clinical study site staff, and the broader ecosystem that is enabling important research and development work to continue at NGM and across our industry.”

Key First Quarter and Recent Highlights

 

Cardio-metabolic and liver disease

 

“We are pleased to have initiated our Phase 2b ALPINE 4 clinical study and thrilled we have achieved this significant milestone, marking our first study in F4 NASH patients with well-compensated cirrhosis,” said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM. “We anticipate that the COVID-19 pandemic will impact activation of additional trial sites, and we plan to work closely with our target sites to navigate their processes and needs in an effort to mitigate delays. Reversing fibrosis and bringing advanced stage NASH patients back from the brink of liver transplant could have a profound, potentially life-saving impact. Based on the rapid, robust anti-fibrotic treatment effect we have seen with aldafermin to date in F2 and F3 NASH patients, we are encouraged by the potential to see activity in a patient population facing a particularly critical need for effective therapeutic solutions.”  

 

 

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Ophthalmic disease

Cancer

Merck Collaboration

Merck has a one-time option to license NGM pipeline programs, other than aldafermin and NGM395, following human proof-of-concept trials, under the terms of the companies’ ongoing strategic collaboration. Upon exercising any such options, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co‑funded program in the United States.

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First Quarter Financial Results

 

 

 

 

About NGM Biopharmaceuticals, Inc.

NGM is a biopharmaceutical company focused on developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit us at 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 “continue,” “move forward,” “advance,” “anticipates,” “expect,” “plans” 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 the advancement of NGM’s clinical and preclinical pipeline; the impact of the COVID-19 pandemic on clinical trial plans and timelines, including enrollment, activation and initiation of additional trial sites and results of NGM’s clinical trials; the continued progress of, and the timing of enrollment and results of, NGM’s clinical trials, including timing of preliminary results of the ALPINE 2/3 study, the presentation of results of the Phase 1 study of NGM621 for the potential treatment of geographic atrophy and the initiation of the related Phase 2 study; the safety, tolerability and efficacy of NGM’s product candidates; and continued development of additional product candidates, including NGM621 in patients with GA, NGM120 in patients with CACS and cancer and NGM395. 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 annual report on Form 10-K for the year ended December 31, 2019 and future filings and reports that NGM makes from time to time with the United States Securities and Exchange Commission. 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.

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NGM BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

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 NGM BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

*The Condensed Consolidated Balance Sheet as of December 31, 2019 has been derived from the audited financial statements as of that date.