GlobeNewswire Inc | May 20, 2021 08:00AM EDT

May 20, 2021

-- New clinical data accepted for oral and e-Poster presentation atAACE --

-- e-ECE clinical data previously presented at Endocrine Societys 2021 annual meeting --

NEEDHAM, Mass., May 20, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), (Chiasma or the Company), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, today announced that it will virtually present encore data from its MPOWERED Phase 3 clinical trial at the 23rd European Congress of Endocrinology (e-ECE) (May 22-26, 2021) and new data from the MPOWERED trial at the 30th Annual American Association of Clinical Endocrinology (AACE) Meeting (May 26-29, 2021).

Oral presentations and posters for display are summarized below:

e-ECE 2021 Oral PresentationTitle A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor LigandsPresenter: Maria Fleseriu, M.D., FACE, Professor, Medicine and Neurological Surgery, Director OHSU Northwest Pituitary CenterSession Date/Time: Wednesday, May 26, 2021, 8:30 a.m. 9:30 a.m. EDT

e-ECE 2021 e-Poster PresentationsTitle Safety Results from MPOWERED, a Phase 3 Trial of Oral Octreotide Capsules in Adults with AcromegalyPresenter: Pamela Freda, M.D., Columbia University Session Date/Time: Monday, May 24, 2021, 8:00 a.m. 8:30 a.m. EDT

Title Oral Octreotide Capsules Lowered Incidence and Improved Severity of Acromegaly Symptoms Compared to Injectable Somatostatin Receptor LigandsResults from the MPOWERED TrialPresenter: Nienke Biermasz, M.D., Ph.D., Leiden University Medical Center Session Date/Time: Tuesday, May 25, 2021, 8:00 a.m. 8:30 a.m. EDT

Title: Addition of Cabergoline to Oral Octreotide Capsules May Improve Biochemical Control in Patients with Acromegaly Who Are Inadequately Controlled with MonotherapyPresenter: Maria Fleseriu, M.D., FACE, Professor, Medicine and Neurological Surgery, Director OHSU Northwest Pituitary CenterSession Date/Time: Tuesday, May 25, 2021, 8:00 a.m. 8:30 a.m. EDT

Title Improved Acromegaly Patient Satisfaction with Oral Octreotide Capsules Compared with Injectable Somatostatin Receptor Ligands in the MPOWERED TrialPresenter: Murray B. Gordon, M.D., Allegheny General HospitalSession Date/Time: Wednesday, May 26, 2021, 8:00 a.m. 8:30 a.m. EDT

AACE 2021 Oral PresentationTitle: Improved Quality of Life and Work Productivity in Patients with Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED TrialPresenter: Nienke Biermasz, M.D., Ph.D., Leiden University Medical CenterSession Date/Time: Thursday, May 27, 2021, 1:30 p.m. 1:45 p.m. EDT

AACE 2021 Late-Breaker e-Posters - Available online via the virtual e-Poster Gallery beginning May 26Title: Effects of Prior Injectable Somatostatin Receptor Ligand Type and Dose in Patients with Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED TrialLead Author: Murray B. Gordon, M.D., Allegheny General Hospital

Title: Injection Site Reactions and Their Impact in Patients with Acromegaly Receiving Injectable Somatostatin Receptor Ligands in the Phase 3 MPOWERED TrialLead Author: Murray B. Gordon, M.D., Allegheny General Hospital

To register and view the full schedules as well as abstracts, visit e-ECEs website here and AACEs website here.

Chiasma will sponsor a product theatre presentation at the AACE annual meeting titled Understanding the Management of Acromegaly with MYCAPSSA (octreotide) Delayed-Release Oral Capsules on Wednesday, May 26 at 2:45 p.m. EDT. Anthony P. Heaney, M.D., Ph.D., Professor, UCLA, will lead the presentation and a live Q&A session.

About the MPOWEREDTrial

The MPOWERED trial was a global, non-inferiority, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA in theEuropean Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial inJune 2019, of which 92 patients were deemed responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules (n=55) or injectable somatostatin receptor ligands (octreotide LAR or lanreotide autogel) (n=37), and then followed for an additional nine months. The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with leading injectable somatostatin analogs.

About MYCAPSSA

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE

MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

CONTRAINDICATIONS

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

Blood sugar, thyroid levels, and vitamin B12levels should be monitored and treated accordingly.

Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

ADVERSE REACTIONS

The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

DRUG INTERACTIONS

The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

PREGNANCY

Advise premenopausal females of the potential for an unintended pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch

The full Prescribing Information for MYCAPSSA is available atwww.MYCAPSSA.com.

About Acromegaly

Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections intheUnited States.

About Chiasma

Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. InJune 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered inNeedham, MAwith a wholly owned subsidiary inIsrael. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the companys website atwww.chiasma.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the MPOWERED trial and the therapeutic potential of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the companys control, that may cause actual events or results to differ materially from the companys current expectations. Managements expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the companys actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Chiasmas Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

Investor Relations and Corporate Communications:Ashley RobinsonLifeSci Advisors, LLC617-430-7577arr@lifesciadvisors.com

Media Relations:Patrick BurseyLifeSci Communications646-876-4932pbursey@lifescicomms.com