8-K

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): July 19, 2021

9 Meters Biopharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-37797	27-3948465
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

8480 Honeycutt Road, Suite 120, Raleigh, NC 27615

(Address of principal executive offices) (Zip Code)

(919) 275-1933

(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 $0.0001 Par Value	NMTR	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 1.01. Entry into a Material Definitive Agreement.

Reference is made to Item 2.01 of this Current Report on Form 8-K, which is incorporated into this Item 1.01 by reference.

Item 2.01. Completion of Acquisition or Disposition of Assets.

On July 19, 2021, 9 Meters Biopharma, Inc., a Delaware corporation (the “Company”), entered into and closed an Asset Purchase Agreement (the “Purchase Agreement”) with Lobesity LLC, a Delaware limited liability company (“Lobesity”), pursuant to which the Company acquired global development rights to a proprietary and highly specific humanized monoclonal antibody that targets glucose-dependent insulinotropic polypeptide, as well as related intellectual property (the "Acquisition").

Pursuant to the Purchase Agreement, the Company paid a combination of cash and equity consideration in the form of a $5 million upfront payment, as 40% cash and 60% equity (consisting of 2,417,211 shares of unregistered common stock priced at the Company’s 30-day volume weighted-price immediately prior to the closing), plus the right to contingent payments including certain worldwide regulatory and clinical milestone payments totaling up to $45.5 million, global sales-related milestone payments totaling up to $50 million, and, subject to certain adjustments, a mid-single digit royalty on worldwide net sales.

To satisfy the Company’s post-closing rights to indemnification under the Purchase Agreement, 604,303 of the shares issued to Lobesity are subject to holdback restrictions for 18 months following closing of the transaction (the “Holdback Shares”). The Company’s right to indemnification will be satisfied through the recovery of these Holdback Shares or paid in cash by Lobesity.

The Purchase Agreement includes a reversion right, pursuant to which, upon the failure of the Company to satisfy certain objectives within the time period specified in the Purchase Agreement, Lobesity may cause all purchased assets to be assigned to Lobesity.

The Purchase Agreement contains representations and warranties that the parties made to, and are solely for the benefit of, each other. Investors and security holders should not rely on the representation and warranties as characterizations of the actual state of facts since they were made only as of the date of the Purchase Agreement. Moreover, information concerning the subject matter of such representation and warranties may change after the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures.

The foregoing description of the Purchase Agreement is qualified in its entirety by reference to the complete text of the Purchase Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. The Company intends to redact certain portions of the Purchase Agreement for confidentiality purposes.

Item 3.02. Unregistered Sales of Equity Securities.

Pursuant to the terms of the Purchase Agreement, the Company issued shares of common stock to Lobesity. The number of shares issued, the nature of the transaction and the nature and amount of consideration received by the Company are described in Item 2.01 of this Form 8-K, which is incorporated by reference into this Item 3.02. The shares of common stock issued pursuant to the Purchase Agreement were not registered under the Securities Act in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and on similar exemptions under applicable state laws.

Item 8.01. Other Events.

On July 19, 2021, the Company issued a press release regarding the matters discussed in this Current Report on Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

On July 19, 2021, the Company posted a corporate presentation regarding the Acquisition described in this Current Report on Form 8-K, which can be found on the Company’s website at www.9meters.com under the section titled Investors. A copy of the Company’s presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
Exhibit 99.1	Press Release dated July 19, 2021.
Exhibit 99.2	9 Meters Biopharma, Inc. July 2021 Presentation.

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.

	9 Meters Biopharma, Inc.
Date: July 19, 2021	By:	/s/ Edward J. Sitar
		Edward J. Sitar
		Chief Financial Officer

EX-99.1

                        PRESS RELEASE

9 Meters Biopharma, Inc. Announces the Acquisition of Humanized Anti-GIP Monoclonal Antibody from Lobesity

–Broadens existing pipeline with a monoclonal antibody against a novel target, glucose-dependent insulinotropic polypeptide (GIP) –

–First planned indication is Prader-Willi Syndrome-

–IND-enabling studies ongoing with first-in-human studies anticipated in 2023 –

–Transaction does not impact corporate guidance and company remains fully financed into 2023 with co-lead programs’ in short bowel syndrome (Phase 2) and in celiac disease (Phase 3) –

RALEIGH, NC, July 19, 2021 – 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company focused on rare and unmet needs in gastroenterology, today announced that the Company has acquired global development rights to a proprietary and highly specific humanized monoclonal antibody (mAb), LOB-0136 (now known as NM-136) that targets glucose-dependent insulinotropic polypeptide (GIP), in addition to related intellectual property from Lobesity LLC, a privately-held biotechnology company focused on breakthrough research and development for metabolic diseases and related disorders.

GIP is a hormone found in the upper small intestine that is released into the blood after food is ingested. Its concentration increases significantly with overeating, leading to higher glucose absorption and greater insulin release. These changes lead to increased glucose uptake into fat cells, which can contribute to obesity and obesity-related disorders such as Prader-Willi Syndrome (PWS). Occurring in approximately one out of every 20,000 births, PWS is recognized as the most common genetic cause of life-threatening childhood obesity.

NM-136, an anti-GIP mAb, has been shown to prevent GIP from binding to its receptor and to decrease nutrient absorption from the intestine. In preclinical obesity models, it has been shown to markedly decrease weight and abdominal fat and to improve lipid profiles. 9 Meters plans to continue the manufacturing optimization and IND-enabling studies, as well as conduct a clinical proof-of-concept study in PWS in 2023.

“Continuing to advance NM-136 will be a very important step forward for patients currently living with PWS and suffering from this life-threatening disease,” said John Temperato, President and Chief Executive Officer of 9 Meters. “This meaningful therapeutic complements and broadens our pipeline of digestive disease assets, while providing us strategic options within our expanded portfolio.”

Daniel Lewis, Chief Executive Officer of Lobesity added, “We’re excited to see our science continue through the development process with the 9 Meters team. Their expertise in the digestive disease space and commitment to patients leaves our team confident that one day patients with PWS may benefit from this novel drug which has shown positive preclinical results.”

9 Meters and Lobesity have agreed to an asset purchase agreement, pursuant to which 9 Meters will acquire LOB-0136, related analogues and all related intellectual property and other related assets of Lobesity for a combination of 40% cash and 60% equity consideration in the form of a $5 million upfront payment (with equity priced at 9 Meters’ 30-day volume weighted average price immediately prior to the closing of the transaction and issued in the form of unregistered common stock), plus the right to contingent payments including certain worldwide regulatory and clinical milestone payments totaling up to $45.5 million, global sales-related milestone payments totaling up to $50 million and, subject to certain adjustments, a mid-single digit royalty on worldwide net sales.

                        PRESS RELEASE

About NM-136 (formerly LOB-0136)

NM-136 is a long-acting, highly specific humanized mAb that binds to GIP. In research models, NM-136 reduced nutrient absorption from the intestine, as well as nutrient storage without affecting appetite, resulting in decreased fat deposition. The candidate is designed to prevent GIP from binding to its receptor, thereby decreasing GIP activity. Studies to date indicate a potential protective effect of NM-136 against a variety of metabolic conditions.

About 9 Meters Biopharma

9 Meters Biopharma, Inc. ("the Company") is a rare and unmet needs-focused gastroenterology company. The Company is advancing vurolenatide, a proprietary long-acting GLP-1 agonist, into a Phase 2 trial for short bowel syndrome (SBS), a rare, orphan disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for symptom improvement in non-responsive celiac disease.

For more information, please visit www.9meters.com or follow 9 Meters on Twitter and LinkedIn.

Forward-looking Statements

This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks associated with acquiring and developing additional compounds; uncertainties associated with the clinical development and regulatory approval of product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; and risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, Form 10-Q for the quarter ended March 31, 2021, and in other filings that the Company has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Corporate Contacts:

Edward J. Sitar

Chief Financial Officer

9 Meters Biopharma, Inc.

investor-relations@9meters.com

www.9meters.com

SOURCE: 9 Meters Biopharma

                        PRESS RELEASE

Media Contact:

Veronica Eames

LifeSci Communications, LLC

veames@lifescicomms.com

203-942-4626

Investor Contact:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

cdavis@lifesciadvisors.com

212-915-2577

SOURCE: 9 Meters Biopharma

EX-99.2

9 Meters – Lobesity Asset Purchase Acquisition July 19, 2021

Forward Looking Statements This presentation includes forward-looking statements based upon the Company's current expectations. Forward- looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks associated with making and integrating acquisitions; uncertainties associated with the clinical development and regulatory approval of product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; and risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements because of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, Form 10-Q for the quarter ended March 31, 2021, and in other filings that the Company has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. 2

Lobesity Company Overview • Privately-held company based in Cleveland, OH (Lead investor is Metro Health System) • Founded in 2015 by researchers Michael Wolfe, MD (inventor of Pepcid Complete® and former Chair of the Advisory Board for GI Drugs at FDA) and Michael Boylan, PhD (recognized expert in GI hormones and receptors) • Company is based on the founders’ years-long work on glucose-dependent insulinotropic peptide (GIP) – an incretin hormone secreted by the intestinal tract post-prandially which controls blood glucose and energy • A proprietary anti-GIP mAb, herein known as NM-136, targets circulating GIP ligand preventing it from binding its’ receptor which could potentially have profound effects in numerous metabolic disorders, including an orphan designated metabolic disease known as Prader-Willi Syndrome (PWS) 3

Transacted Key Deal Terms 4 9 Meters and Lobesity have agreed to an asset purchase agreement, pursuant to which 9 Meters will acquire NM-136 (formerly LOB-0136), related analogues, and all related intellectual property and other related assets of Lobesity for: • A combination of cash and equity consideration in the form of a $5 million upfront payment, as 40% cash and 60% equity* • Plus the right to contingent payments including certain worldwide regulatory and clinical milestone payments totaling up to $45.5 million • Global sales-related milestone payments totaling up to $50 million • And subject to certain adjustments, a mid-single digit royalty on worldwide net sales. *priced at 9 Meters’ 30-day volume weighted average price immediately prior to the closing of the transaction and issued in the form of unregistered common stock

▪ Glucose-dependent insulinotropic peptide (GIP) is a 42-amino acid hormone made in K-cells localized to the proximal gut, and it is secreted after eating food containing glucose and fat ▪ Although originally named asan acid blocker, the principal property of GIPis the stimulation of insulin release from pancreatic islet β-cells in the presence of glucose Accordingly, GIP is also known as “glucose-dependent insulinotropic polypeptide” ▪ GIPenhances gut nutrient absorption and increases glucose uptake into fat cells. - GIP also increases insulin & further increases nutrient uptake and storage NM-136 is a specific humanized anti-GIP monoclonal antibody: ▪ Lobesity has developed a highly specific monoclonal antibody which binds circulating GIP and removes it – unable to agonize the GIP receptor – behaving as a GIP antagonist Lobesity and GIP Monoclonal Antibody Obesity and related disorders of increased nutrient uptake and storage are facilitated byGIP. 5 Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology. 2007 May;132(6):2131-57.

NM-136 Complements and Adds Potential Strategic Optionality to 9 Meters Pipeline NM-136 Mechanism of Action: • GIP mAb decreases nutrient uptake & fat storage and potentially effective in metabolic and obesity-related disorders, where this is a key problem • GIP mAb also potentially decreases intestinal nutrient absorption 6 Boylan MO, Glazebrook PA, Tatalovic M, Wolfe MM. Am J Physiol Endocrinol Metab. 2015 Dec 15;309(12):E1008-18 NM-136 (proprietary anti-GIP mAb)

NM-136 Pre-Clinical Data Showed Key Improvements • In this study done in mice, NM-136 (30 mg/kg) attenuated the insulin response to oral glucose by 2/3 and eliminated the insulin response to co-administered glucose. • The effect at 60 mg/kg weekly on weight gain decreased by 46.5% and was equivalent to the low-fat diet control mice. • There were NOdifferences in the amount of food consumed among the treatmentgroups. Source: Boylan MO et al. Am JPhysiol 2015; 309:E1008-E1018: https://doi.org/10.1152/ajpendo.00345.2015 7

Prader-Willi Syndrome Overview Prader-Willi syndrome is characterized by: • Weight gain caused by hyperphagia: Chronic feeling of insatiable hunger causing morbid obesity • Hyperphagia starts at very young age and usually lasts until death • Intellectual/emotional disabilities and psychiatric disorders • Multiple hormonal deficiencies resulting in short stature and incomplete development • Metabolic dysfunction and early death Up to 20,000 13,000 –18,000 ~1:20,000INCIDENCE 30-40 YEARSMEDIAN AGE / MORTALITY PREVALENT CASES U.S. EUROPE 8 Bohonowych J, Miller J, McCandless SE, Strong TV. The Global Prader–Willi Syndrome Registry: Development, Launch, and Early Demographics. Genes. 2019; 10(9):713.

Mid 2021 NM-136 acquired by 9 Meters IND-enabling and CMC optimization underway by Lobesity Late 2021/Full Year 2022 Complete IND-enabling program Pre-IND meeting IND preparation/filing mAb production/scale-up 2023 Bioanalytical Start Phase 1/Human PK NM-136 Development Plan & Timeline 9

Thank You John Temperato President & CEO jtemperato@9meters.com Edward Sitar Chief Financial Officer esitar@9meters.com 8480 Honeycutt Road, Suite 120 Raleigh, NC 27615 Telephone: 1-919-275-1933 info@9meters.com www.9meters.com Twitter LinkedIn

XML

Cover	Jul. 19, 2021
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jul. 19, 2021
Entity Registrant Name	9 Meters Biopharma, Inc.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-37797
Entity Tax Identification Number	27-3948465
Entity Address, Address Line One	8480 Honeycutt Road
Entity Address, Address Line Two	Suite 120
Entity Address, City or Town	Raleigh
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27615
City Area Code	919
Local Phone Number	275-1933
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock $0.0001 Par Value
Trading Symbol	NMTR
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Central Index Key	0001551986
Amendment Flag	false