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 6, 2020
 
 
 
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 x
 
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. x
 
Item 1.02
Termination of a Material Definitive Agreement

As disclosed by 9 Meters Biopharma, Inc. (formerly known as Innovate Biopharmaceuticals, Inc.), a Delaware corporation (the “Company”), in its Current Report on Form 8-K filed with the Securities and Exchange Commission on April 22, 2020, the Company was granted a loan from Central Bank in the aggregate amount of $220,205, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the CARES Act, which was enacted March 27, 2020. On May 7, 2020, the Company decided that it would return all funds borrowed under the PPP on or before May 14, 2020.

Item 2.01
Completion of Acquisition or Disposition of Assets.

On May 6, 2020, the Company consummated its merger with Naia Rare Diseases, Inc., an exempted company incorporated under the laws of the Cayman Islands (“Naia”), in accordance with the terms of a previously disclosed Agreement and Plan of Merger (the “Merger Agreement”), dated April 30, 2020, by and among the Company, Naia Merger Sub, Inc., a Delaware corporation and indirect wholly owned subsidiary of the Company (“First Merger Sub”), Second Naia Merger Sub, LLC, a Delaware limited liability company and indirect wholly owned subsidiary of the Company (“Second Merger Sub”), Naia, and Naia Limited, an exempted company incorporated under the laws of the Cayman Islands, as Shareholders’ Agent.

Pursuant to the Merger Agreement, First Merger Sub merged with and into Naia, with Naia as the surviving corporation, and as part of the same overall transaction, Naia then merged with and into Second Merger Sub, with Second Merger Sub as the surviving entity and continuing as an indirect wholly owned subsidiary of the Company. The Company retained its public reporting and NASDAQ listing status.

In accordance with the terms of the Merger Agreement, at the closing all of Naia’s outstanding ordinary shares, Series B Preference Shares, Series A Preference Shares and Series 1 Preference Shares, each with a par value of $0.001 per share, were converted into the right to receive, in the aggregate, 4,835,438 shares of common stock of the Company. Each outstanding Naia warrant or option was exercised or cancelled prior to the effective time of the Merger. The Company agreed to register for resale the shares of common stock issued to Naia pursuant to the Merger Agreement.

Additionally, the shareholders of Naia received aggregate cash consideration of $2,112,000, plus the payment of certain amounts paid prior to closing of the merger by Naia pursuant to its license agreements with Amunix totaling $70,000. Consideration for the Naia Merger also includes future development and sales milestone payments worth up to $80,424,000 and royalties on net sales of certain products to which Naia has exclusive rights by license.

As of May 6, 2020, following the completion of the Merger, the pre-closing Company stockholders owned approximately 95.0% of the Company’s outstanding common stock and the former Naia shareholders owned approximately 5.0% of the Company’s outstanding common stock. As of May 6, 2020, after giving effect to the Merger, there were 96,251,342 shares of Common Stock outstanding, and 382,783 shares of Series A Preferred Stock outstanding, which will be convertible into 38,278,300 shares of Common Stock.

The issuance of the shares of common stock to the former shareholders of Naia in connection with the Merger and the related transactions did not require approval by Company stockholders. Prior to the consummation of the Merger, the shareholders of Naia approved the Merger Agreement at an extraordinary meeting of Naia shareholders.

The foregoing description of the Merger Agreement is not complete and is qualified in its entirety by reference to the Merger Agreement, which was previously filed as Exhibit 2.1 to the Current Report on Form 8-K filed on May 4, 2020, which is incorporated herein by reference.





Item 3.02
Unregistered Sales of Equity Securities.

Pursuant to the terms of the Merger Agreement and in connection with the Merger, the Company issued shares of common stock to former Naia shareholders. 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 in connection with the Merger 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 May 7, 2020, 9 Meters Biopharma, Inc. (the "Company") issued a press release to announce it has closed its merger with Naia Rare Diseases. A copy of such release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01.
Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.
Description
Exhibit 99.1






  
 
 

 
 
 
 





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: May 8, 2020
By:
 
/s/ Edward J. Sitar
 
 
 
Edward J. Sitar
 
 
 
Chief Financial Officer
 
 
 
 

 

 
 
 



9 Meters Biopharma, Inc Announces the Closing of Naia Rare Diseases Acquisition

-Previously announced in late 2019 this transaction accelerates the development of
novel long-acting GLP-1 receptor agonist as the Company’s Co-Lead Program-
               
            - Phase 2 trial for Short Bowel Syndrome planned
in 2H 2020 and top-line results in 2021-

Raleigh, NC, May 07, 2020 - 9 Meters Biopharma, Inc (Nasdaq: NMTR), today announced that it has closed the merger with Naia Rare Diseases, a company developing a proprietary long-acting glucagon like peptide-1 (GLP-1) receptor agonist for the treatment of Short Bowel Syndrome (SBS) and other rare gastrointestinal diseases. The deal also includes a proprietary long-acting glucagon like peptide-2 (GLP-2) being developed for an undisclosed orphan indication. The transaction follows the recent financing, led by Orbimed Advisors, LLC, announced earlier this week after signing $22 million in new funding.

“Our strategy and approach is completely aligned with that of Naia Rare Diseases,” said John Temperato President & Chief Executive Officer of 9 Meters, “We aim foremost to improve the lives of patients with incapacitating GI disorders. For some of these disorders, there are currently no FDA-approved treatments, and for others, currently available therapies are sub-optimal. The addition of Naia’s pipeline of long-acting GLPs greatly enhances our ability to do exactly that.”

Our mission at 9 Meters is straightforward and focused - The Company believes its’ long acting GLP-1 agonist, NM-002, is designed specifically to address the current gaps in the standard of care, by decreasing the rapid gut transit time in patients with SBS. Currently, NM-002 is the only therapy being developed in SBS that directly addresses increased bowel motility. By slowing down gut motility, it acts as a natural brake on stomach contractions and gut transit, causing an increase in nutrient absorption and potentially allowing patients to eliminate the need for parenteral nutrition while improving their quality of life.

NM-002 has demonstrated efficacy and an extended half-life up to 30 days in a 70-patient clinical study1 and received Orphan Designation by the U.S. Food and Drug Administration. The companies, along with Cedars-Sinai Medical Center, plan to initiate a clinical program in SBS in mid-2020, with the goal of developing a potentially safer, more efficacious and convenient therapy.

Andrew Jablonski of the Short Bowel Syndrome Foundation (SBSF) commented that, “The development of this new therapy is extremely innovative in that it could potentially help the gut absorb more nutrients from patients’ daily intake. It is promising to see the development of new therapies in SBS to help those living with this condition. With few options in this rare disease, including total parenteral nutrition (TPN) and tube feedings which are confining for many, new agents such as NM-002 could allow weaning of typical therapies, translating into a major milestone for both the patient and the caregiver.”

H. Daniel Perez, M.D., co-founder, chairman and CEO of Naia Rare Diseases, said, "The potential behind the combination of these companies is powerful. We believe the high-caliber, experienced team will advance our exciting pipeline, as they share our commitment of bringing innovative new

-1-


medicines to patients suffering from SBS and other debilitating gastrointestinal rare diseases with few options."

Based on encouraging and published proof-of-concept data, 9 Meters will initiate a Phase 1b/2a clinical trial in mid 2020. This study will assess the safety and tolerability of three different doses in adult patients with SBS. We expect to have topline data in the first half of 2021.

About Short Bowel Syndrome
According to the National Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK), SBS is a rare syndrome of problems related to poor absorption of nutrients as a result of at least half of the small intestine being removed and sometimes all or part of the large intestine; significant damage to the small intestine; or poor motility, or movement inside of the intestines.2 The incidence of SBS is poorly known but estimated at about 5 to 10 patients per year per million population. In adults, the incidence of SBS requiring at-home parenteral nutrition is estimated at two adult patients per year per million population.3 Pharmacologic therapies for SBS include trophic factors, such as short-acting daily injectable GLP-2 analogues, which may not be appropriate for all patient types.

About the Short Bowel Syndrome Foundation
The Short Bowel Syndrome Foundation, Inc. (SBSF) is a 501c3 organization that helps support and educate those who live with, and care for Short Bowel Syndrome. In the last nine years, the Foundation has helped grow a community of patients and caregivers supporting each other through social media. SBSF offers support, advocacy and education for patients and caregivers to help give a better understanding of SBS and its treatments. SBSF administers online support groups for adults, international patients, along with a family and caregivers support group. The Foundation has been on several different expert advisory boards for short bowel syndrome, and has served as an expert consultant for NPS Pharma, Naia Rare Diseases, and Shire Pharmaceuticals respectively. The Foundation strives to continue working alongside industry leaders to create better patient and caregiver experiences. 

About 9 Meters Biopharma
9 Meters Biopharma, Inc. is a rare, orphan and unmet needs focused GI company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into 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 patient-reported symptom improvement in non-responsive celiac disease.
For more information, please visit www.9meters.com.
About Naia Rare Diseases
Naia Rare Diseases is a development stage biopharmaceutical company developing novel drugs for rare gastrointestinal disorders. The company is pursuing three development programs including NB 1001 for Adult SBS, NB 1001 for pediatric SBS and NB 1002, a GLP-2 agonist, for an undisclosed orphan gastrointestinal indication. Naia Rare Diseases has been funded primarily by its parent

-2-


company, Naia Limited, a company focused on building and funding new biotech companies using de-risked clinical stage assets. For more information, please visit www.naiapharma.com.

Forward-looking Statements 
This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on Nasdaq; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. 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: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) 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; (v) the impact of COVID-19 on our operations, clinical trials or proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the proposed Merger and the Naia acquisition, including with respect to future financial and operating results. 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. 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 Innovate Biopharmaceuticals, Inc. Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings that Innovate 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
H. Daniel Perez, MD

-3-


Chief Executive Officer
Naia Rare Diseases
dperez@naiapharma.com

Media contact
Amy Jobe, Ph.D.
LifeSci Communications, LLC
ajobe@lifescicomms.com
315-879-8192
Andrew E. Jablonski
The Short Bowel Syndrome Foundation
ajablonski@shortbowelfoundation.org
402-429-5784

Investor contact
Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
212-915-2577


References:

1.
Data presented at the 71st American Diabetes Association conference (2011)
2.
NIH Health Information - Short Bowel Syndrome
Amiot A, Messing B, Corcos O, Panis Y, Joly F. Determinants of home parenteral nutrition dependence and survival of 268 patients with non-malignant short bowel syndrome. Clin Nutr 2013;32(3):368-74


-4-