# EDGAR Filing Document

**Accession Number:** 0001551986
**File Stem:** 0001551986-23-000019
**Filing Date:** 2023-3
**Character Count:** 17863
**Document Hash:** ee10acef3cec651d0aecfc0dda961178
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001551986-23-000019.hdr.sgml**: 20230328

**ACCESSION NUMBER**: 0001551986-23-000019

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230328

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230328

**DATE AS OF CHANGE**: 20230328

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** 9 METERS BIOPHARMA, INC.
- **CENTRAL INDEX KEY:** 0001551986
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 273948465
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37797
- **FILM NUMBER:** 23766249

**BUSINESS ADDRESS:**
- **STREET 1:** 4509 CREEDMOOR ROAD
- **STREET 2:** SUITE 201
- **CITY:** RALEIGH
- **STATE:** NC
- **ZIP:** 27612
- **BUSINESS PHONE:** 919-275-1933

**MAIL ADDRESS:**
- **STREET 1:** 4509 CREEDMOOR ROAD
- **STREET 2:** SUITE 201
- **CITY:** RALEIGH
- **STATE:** NC
- **ZIP:** 27612

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INNOVATE BIOPHARMACEUTICALS, INC.
- **DATE OF NAME CHANGE:** 20180201

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Monster Digital, Inc.
- **DATE OF NAME CHANGE:** 20150930

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Tandon Digital, Inc.
- **DATE OF NAME CHANGE:** 20120611

?xml version="1.0" ? nmtr-20230328

**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): March 28, 2023**

**9 Meters Biopharma, Inc.**

**(Exact name of registrant as specified in its charter)**

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

---

**4509 Creedmoor Road, Suite 201, Raleigh, NC 27612**

**(Address of principal executive offices) (Zip Code)**

**(919) 275-1933**

**(Registrant's telephone number, include area code)**

**8480 Honeycutt Road, Suite 120, Raleigh, NC 27615**

**(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:

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| | | |
|:---|:---|:---|
| 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).

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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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| | |
|:---|:---|
| **Item 2.02.** | **Results of Operations and Financial Condition.** |

---

On March 28, 2023, 9 Meters Biopharma, Inc. (the "Company") issued a press release providing a business update and announcing financial results for the fourth quarter and full year 2022. A copy of such release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Pursuant to General Instruction B.2 of Current Report on Form 8-K, the information contained in, or incorporated into, Item 2.02, including the press release attached as Exhibit 99.1, is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, amended, except as shall be expressly set forth by specific reference to such filing.

---

| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.** |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Exhibits</u>

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| Exhibit 99.1 | <u>[Press Release dated March 28, 2023.](ex-991pressrelease32823.htm)</u> |
| Exhibit 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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**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. | 9 Meters Biopharma, Inc. |
| Date: March 28, 2023 | By: | /s/ Bethany Sensenig |
|  |  | Bethany Sensenig |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

![image_0a.jpg](image_0a.jpg)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

**Press Release**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

**9 Meters Biopharma Provides Business Update and Reports Financial Results for Fourth Quarter and Full Year 2022**

**RALEIGH, NC / ACCESSWIRE / March 28, 2023 /** 9 Meters Biopharma, Inc. (Nasdaq:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today provided an overview of its recent achievements, upcoming milestones, and financial results for the fourth quarter and full year ended December 31, 2022.

"Our priority for 2023 remains to progress our Phase 3 vurolenatide program for short bowel syndrome including securing a clinical development and commercialization partner," commented John Temperato, President and Chief Executive Officer of 9 Meters Biopharma. "We firmly believe vurolenatide can establish a new standard of care in the treatment of short bowel syndrome with the potential to address the full SBS patient population and offer a rapid onset of action, sustained response, and a potentially convenient dosing regimen."

Mr. Temperato continued, "Our Board of Directors and management team remain focused on ensuring that the Company is positioned to execute on our clinical and preclinical milestones as our financial position allows us to do so. The current financial markets, particularly for small-cap pharmaceutical companies, have been challenging in recent months; however, we are pleased to have recently strengthened our balance sheet with an equity financing and have also implemented cost-saving measures to further our cash runway. We believe that these actions align our strategic and financial goals and will help move the Company forward."

**<u>Clinical Development and Business Highlights</u>**

**Phase 3 study of vurolenatide in Short Bowel Syndrome (SBS)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Phase 3 study of vurolenatide, VIBRANT 2 (**V**urolenat**I**de for short **B**owel syndrome **R**egardless of p**A**renteral support requireme**NT**), is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of vurolenatide 50 mg administered subcutaneously every two weeks in adults with SBS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• VIBRANT 2 incorporates two primary endpoints to evaluate the efficacy of vurolenatide in SBS in patients dependent on parenteral support (PS) (on PS at least 3 times per week) and all other patients (on PS fewer than 3 times per week).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In March 2023, we received additional clarifying comments from the FDA on the VIBRANT 2 study protocol. The comments provide additional clarification and direction on specific elements of the study protocol and design. Based on the comments received, the Company will align with the recommendations provided, including the use of a continuous variable endpoint and a 24-week study duration for both subgroups of patients in the trial. Approximately 120 patients will be enrolled in the study and an interim analysis will be conducted when 50% of patients reach 24 weeks. Use of a continuous variable endpoint is viewed by the Company as a more robust measurement of efficacy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Study design continues to address the entire SBS population, serving patients in need of improved therapeutic options as well as helping the more than 50% of patients who do not meet the PS requirement threshold and are currently not served by existing therapeutics and late-stage development GLP-2 agonists.

**Presentations on vurolenatide and SBS at ASPEN 2023 Nutrition Science & Practice Conference**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Two abstracts, *Vurolenatide, a novel long-acting glucagon-like peptide-1 (GLP-1) analogue, for patients with short bowel syndrome: A randomized Phase 2 trial* and *Epidemiology of Short Bowel Syndrome in the United States*, have been accepted for presentation at the forthcoming ASPEN 2023 Nutrition Science & Practice Conference to take place in Las Vegas, Nevada from April 20 - 23, 2023.

**NM-136 (anti-GIP humanized monoclonal antibody)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• NM-136 is a novel long-acting, humanized anti-GIP monoclonal antibody. The Company believes NM-136 is a first-in-class humanized monoclonal antibody specifically targeting and binding GIP in the systemic circulation. GIP plays a critical role in promoting nutrient uptake and storage and has been shown to promote fat accumulation in humans.

------

![image_0a.jpg](image_0a.jpg)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

**Press Release**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• A pre-IND meeting with the FDA in the first half of 2023 is expected to provide the Company with important regulatory guidance on the preclinical development plan to support an IND for NM-136 in obesity disorders. Further information is anticipated to be made available in early second quarter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• An abstract, *The prevention and treatment of obesity in wild-type (WT) and hyperphagic leptin-deficient (OB/OB) mice using monoclonal antibodies (mAbs) to glucose-dependent insulinotropic polypeptide (GIP) occurs independently of appetite suppression*, has been accepted for presentation at the forthcoming Digestive Disease Week to take place in Chicago, Illinois from May 6 – 9, 2023.

**<u>Corporate</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• On March 15, 2023, 9 Meters announced the closing of a $5 million registered direct offering priced at-the-market under Nasdaq rules. Proceeds from the offering, together with other available funds, will support the development of the Company's pipeline programs as well as provide funds for working capital and general corporate purposes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Board of 9 Meters approved a cost reduction plan to help extend the cash runway, which will reduce operating expenses and further align the Company's workforce with immediate business needs. Essential activities will be transferred to existing staff members with relevant experience, who will continue to support the Company's key development programs as well as any potential partnerships or collaborations.

**<u>Key Anticipated Near-Term Milestones</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Presentation of Phase 2 study results of vurolenatide in SBS at ASPEN 2023 Nutritional Science & Practice Conference in April.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Presentation of data on the prevention and treatment of obesity using anti-GIP monoclonal antibodies at Digestive Disease Week in May.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Completion of a pre-IND meeting for NM-136 followed by potential IND submission in the second half of 2023.

**<u>Fourth quarter and full year 2022 Financial Results</u>**

As of December 31, 2022, the Company had total cash and cash equivalents of approximately $29.7 million, compared to approximately $39.4 million as of September 30, 2022. Included in total cash and cash equivalents was approximately $17.0 million and $23.5 million of restricted cash as of December 31, 2022 and September 30, 2022, respectively.

Subsequent to year-end December 2022, the Company amended its convertible note and repaid approximately $16.8 million that was previously classified as restricted cash. In March 2023, the Company raised $5 million in gross proceeds through a registered direct offering. The Company anticipates that its cash runway is sufficient to fund operations into the third quarter of 2023.

9 Meters reported a net loss of approximately $11.9 million and $43.8 million for the fourth quarter and full year 2022, respectively, compared to a net loss of approximately $9.6 million and $36.8 million, respectively in the fourth quarter and full year of 2021. This increase in net loss year over year was primarily due to the advancement of our clinical development programs.

Net loss per share was $0.92 and $3.38 respectively, for the fourth quarter and full year 2022, compared with $0.04 and $0.15 ($0.80 and $3.03 per share on a post-split basis) for the comparable periods in 2021.

**About 9 Meters Biopharma**

9 Meters Biopharma, Inc. is a clinical-stage company pioneering novel treatments for people with rare digestive diseases, GI conditions with unmet needs, and debilitating disorders in which the biology of the gut is a contributing factor. 9 Meters is developing vurolenatide, a proprietary long-acting GLP-1 agonist in Phase 3 development for short bowel syndrome as well as near clinical-stage assets including NM-136 for obesity disorders.

For more information please visit or follow 9 Meters on Twitter, LinkedIn, and Facebook.

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![image_0a.jpg](image_0a.jpg)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

**Press Release**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

**Forward-Looking Statements**

This press release includes forward-looking statements based upon 9 Meters' current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions, anticipated milestones, and 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 various risks and uncertainties, which include, without limitation: our need to raise additional capital to fund our operations for at least the next 12 months as a going concern and to advance our product candidates and preclinical programs, including in light of current stock market conditions; risks related to our ability to successfully implement our strategic plans, including reliance on our lead product candidate; 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; intellectual property risks; risks related to delays in enrollment in and timing of clinical trials; reliance on collaborators; reliance on research and development partners; and risks related to cybersecurity and data privacy. 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 9 Meters' Annual Report on Form 10-K for the year ended December 31, 2021, as amended or supplemented by our Quarterly Reports on Form 10-Q and in other filings that 9 Meters has made and future filings 9 Meters 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. 9 Meters 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 and Media Contact**

Al Medwar

SVP, Investor Relations & Corporate Communications

9 Meters Biopharma, Inc.

<u>investor-relations@9meters.com</u>

Source: 9 Meters Biopharma, Inc.

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