FDA Sort C assembly communications help plans to provoke Part 2 in Q2 with NM-002 for brief bowel syndrome (SBS) utilizing Complete Stool Output (TSO) as a major efficacy consequence measure
Introduced optimistic topline knowledge in December for NM-002, a proprietary long-acting GLP-1, in a Part 1b/2a trial for SBS
Firm’s R&D day on March 23rd to incorporate extra Part 1b/2a research knowledge on parenteral help, pharmacokinetics and high quality of life
Part 3 interim evaluation and topline knowledge for larazotide in celiac illness now anticipated in 2022 because of COVID-19 affect on affected person enrollment
Raised over $58 million from outstanding institutional healthcare traders in 2020
Analysis & Growth Day on Brief Bowel Syndrome deliberate for tomorrow (March 23rd) at 11:00 AM ET – see https://media.rampard.com/20210323/reg.jsp for registration particulars
RALEIGH, NC / ACCESSWIRE / March 22, 2021 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage uncommon and unmet needs-focused gastroenterology firm, right now supplied an summary of its latest achievements and 2021 outlook and reported its monetary outcomes for the fourth quarter and full yr ended December 31, 2020.
Full 12 months & Current Enterprise Highlights
After a latest productive FDA interplay in Q1 2021, the Firm plans to maneuver ahead utilizing whole stool output (TSO) as the first efficacy endpoint in an upcoming Part 2 trial, which we plan to start in Q2 and report last knowledge in This fall.
Multi-center, placebo-controlled, randomized, a number of fixed-dose research in roughly 20 grownup SBS sufferers
Major endpoint: whole stool output (TSO) in comparison with baseline
Quite a few secondary endpoints together with dietary and fluid standing
Introduced optimistic Part 1b/2a topline knowledge for NM-002, a proprietary long-acting GLP-1, for brief bowel syndrome. In December, the Firm reported knowledge that we imagine demonstrated the potential to meaningfully enhance the standard of lifetime of SBS sufferers by bettering stool output and decreasing reliance on parenteral help. The research evaluated the security and tolerability of three escalating fastened doses of NM-002 (50 mg, 100 mg, 150 mg) in 9 adults with SBS over 56 days.
Fast onset and sustained scientific impact following first dose in all 9 sufferers in whole stool output (TSO) quantity and bowel motion frequency.
Further analyses to be mentioned in additional element on the Firm’s R&D day on March 23rd together with parenteral help, pharmacokinetics and high quality of life.
Twice-monthly fixed-dosing routine exhibited a superb security and tolerability profile.
Larazotide Part 3 Replace
Enrollment persevering with in Part 3 celiac illness scientific trial
Given challenges in enrollment associated to the COVID-19 pandemic, interim outcomes and topline knowledge readouts are anticipated in 2022.
Raised greater than $58 million in fairness financings and warrant workouts in 2020 with a further $6.7 million in proceeds from warrants exercised in Q1 2021, demonstrating continued help of administration from long-term institutional healthcare traders:
In Could, the Firm introduced the closing of a $22.5 million personal placement led by Orbimed Advisors, LLC.
In December, the Firm introduced a profitable inventory providing producing internet proceeds of roughly $32 million led by Adage Capital Companions GP, LLC.
John Temperato, President & CEO of 9 Meters Biopharma, commented: “In 2020, we delivered on our plan to ascertain 9 Meters as a number one innovator within the remedy of uncommon and unmet gastroenterology problems. We proceed to advance each of our co-lead GI property and improve our earlier stage pipeline of GI merchandise. After a profitable Part 1b/2a trial with NM-002 in SBS, we’re happy that after session with the FDA we’ll start dosing in a Part 2 trial using whole stool output (TSO) as the first endpoint. We proceed affected person enrollment within the Part 3 larazotide program and are wanting ahead to the interim evaluation in and last topline knowledge in 2022.”
Program Updates and Anticipated Milestones for 2021 and 2022
NM-002 (proprietary long-acting GLP-1 agonist):
Provoke Part 2 research in Q2 2021
Anticipated USAN/INN identify in Q2 2021
Topline Part 2 ends in This fall 2021
Initiation of Part 3 Research in This fall 2021
NM-003 (proprietary lengthy performing GLP-2 agonist):
NM-102 (proprietary tight-junction microbiome modulator):
Introduced optimistic preclinical knowledge in a intestine microbiome-mediated immune checkpoint inhibitor melanoma mannequin in 2020
Progressing into IND-enabling work in 2021
Full 12 months Monetary Outcomes
As of December 31, 2020, the Firm’s money and money equivalents totaled roughly $37.9 million, in comparison with roughly $4.6 million on December 31, 2019. Moreover, $6.7 million in proceeds have been obtained by the Firm from warrant workouts within the first quarter of 2021 (by means of March 19th).
The Firm reported a internet lack of roughly $5.0 million, or $0.03 per share, for the fourth quarter of 2020, in comparison with a internet lack of roughly $8.9 million, or $0.25 per share for the fourth quarter of 2019. The Firm reported a internet lack of roughly $61.5 million, or $0.58 per share, for the yr ended December 31, 2020, in comparison with a internet lack of roughly $27.0 million, or $0.81 per share, for the yr ended December 31, 2019.
About 9 Meters Biopharma
9 Meters Biopharma, Inc. 9 Meters Biopharma, Inc. (“the Firm”) is a uncommon and unmet needs-focused gastroenterology firm. The Firm is advancing NM-002, a proprietary long-acting GLP-1 agonist right into a Part 2 trial for brief bowel syndrome (SBS), a uncommon, orphan illness, in addition to larazotide, a Part 3 tight junction regulator being evaluated for patient-reported symptom enchancment in non-responsive celiac illness.
For extra data, please go to www.9meters.com or comply with 9 Meters on Twitter and LinkedIn.
Ahead-looking Statements This press launch consists of forward-looking statements based mostly upon the Firm’s present expectations. Ahead-looking statements embrace, however will not be restricted to, statements that specific our intentions, beliefs, expectations, methods, predictions or every other statements referring to our future actions or different future occasions or situations. These statements are based mostly on present expectations, estimates and projections about our enterprise based mostly, partly, on assumptions made by administration. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of these dangers and uncertainties, which embrace, with out limitation: (i) uncertainties related to the scientific improvement and regulatory approval of product candidates; (ii) dangers associated to the shortcoming of the Firm to acquire enough extra capital to proceed to advance these product candidates and its preclinical applications; (iii) uncertainties in acquiring profitable scientific outcomes for product candidates and surprising prices that will consequence therefrom; (iv) dangers associated to the failure to comprehend any worth from product candidates and preclinical applications being developed and anticipated to be developed in gentle of inherent dangers and difficulties concerned in efficiently bringing product candidates to market; (v) the affect of COVID-19 on our operations, scientific trials or future financings and (vi) dangers related to the doable failure to comprehend sure anticipated advantages of the Firm’s latest merger and the Naia acquisition, together with with respect to future monetary and working outcomes. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements due to these dangers and uncertainties. These and different dangers and uncertainties are extra totally described in periodic filings with the SEC, together with the components described within the part entitled “Threat Elements” within the Firm’s. Annual Report on Kind 10-Okay for the yr ended December 31, 2020 and in different filings that the Firm has made and future filings the Firm will make with the SEC. You shouldn’t place undue reliance on these forward-looking statements, that are made solely as of the date hereof or as of the dates indicated within the forward-looking statements. The corporate expressly disclaims any obligation or enterprise to launch publicly any updates or revisions to any forward-looking statements contained herein to replicate any change in its expectations with regard thereto or any change in occasions, situations or circumstances on which any such statements are based mostly.
Edward J. Sitar, Chief Monetary Officer
9 Meters Biopharma, Inc.
LifeSci Communications, LLC
Corey Davis, Ph.D.
LifeSci Advisors, LLC
SOURCE: 9 Meters Biopharma
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