 MYCAPSSA U.S. commercial launch planned for the fourth quarter On track to announce MPOWERED Phase 3 trial topline data in the fourth quarterCompany to host conference call today, August 10, at 5pm ETNEEDHAM, Mass., Aug. 10, 2020 GLOBE NEWSWIRE -- Chiasma, Inc. NASDAQ: CHMA, a commercial stage biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020 and provided a business update. Recent Business Highlights Achieved FDA approval of MYCAPSSA, the first and only oral somatostatin analog with the potential to become the new standard of pharmacological care in the long-term maintenance treatment of patients with acromegaly. Demonstrated longer-term durability of efficacy and safety of MYCAPSSA in the 48-week open-label extension OLE of the Phase 3 CHIASMA OPTIMAL study. Bolstered a top-tier launch team including the appointment of biopharmaceutical commercial veteran Anand Varadan as EVP, Chief Commercial Officer. Secured up to 75 million to support the planned commercial launch of MYCAPSSA through a revenue interest financing agreement with HealthCare Royalty Partners HCR. Raised approximately 75 million of net proceeds through an over-subscribed equity financing.Anticipated Upcoming 2020 Milestones U.S. commercial launch of MYCAPSSA planned to commence in the fourth quarter. FDA acceptance and approval of manufacturing supplement to approved MYCAPSSA new drug application NDA to include the primary commercial active pharmaceutical ingredient supplier. Top-line MPOWEREDTM Phase 3 clinical trial results expected to be announced in the fourth quarter.We made significant progress since our last quarterly update, most notably our transition to a commercial stage company following the FDAs approval in June of MYCAPSSA as a novel treatment for acromegaly, stated Raj Kannan, Chief Executive Officer of Chiasma. MYCAPSSA is the first and only oral somatostatin analog treatment option in an injectables only market, a key differentiator that we believe is strongly preferred by many patients with acromegaly. We remain optimistic as we prepare for the commercial launch. To that end, we are building a world class customer-facing organization capable of responding to the challenges and opportunities posed by a predominantly remote launch environment.In parallel, we continue to add to the robust dataset for MYCAPSSA. Notably, the data from the 48-week open-label extension of the CHIASMA OPTIMAL trial demonstrated longer-term durability of safety and efficacy of MYCAPSSA and highlights the strong preference of these acromegaly patients for an oral treatment alternative. We look forward to advancing MYCAPSSA as a preferred treatment option for patients with acromegaly treated with octreotide and lanreotide injectables, Mr. Kannan concluded. Second Quarter 2020 Financial Results GA Expenses: General and administrative expenses were 10.7 million for the second quarter ended June 30, 2020, compared with 2.6 million for the same period of 2019. The current year results include 5.6 million of ongoing pre-commercial activities, an increase in compensation-related expenses, and increased other administrative costs as we prepared for the planned commercialization of octreotide capsules in the U.S. in the fourth quarter of this year. RD Expenses: Research and development expenses were 9.7 million for the second quarter ended June 30, 2020, compared with 5.5 million for the same period of 2019. The increase in current period results was primarily driven by the manufacturing of octreotide capsules to support our commercial launch, costs associated with our disease state registry, scientific literature publications and increased regulatory costs which were offset by a decrease in clinical trial costs. Net Loss: For the quarter ended June 30, 2020, net loss was 21.1 million, or 0.50 per basic share, compared with 7.8 million, or 0.25 per basic share, in the same period of 2019. Cash Position: Chiasma ended the second quarter with cash, cash equivalents, marketable securities and restricted cash of 87.1 million, compared with 92.4 million as of December 31, 2019. In April 2020, the company received a 25 million payment, less certain transaction expenses, from Healthcare Royalty Partners under the previously announced revenue interest financing agreement. In July, the company received an additional 25 million from HCR, triggered by FDA approval of MYCAPSSA. Additionally, also in July, Chiasma raised approximately 75 million of net proceeds from an over-subscribed underwritten public offering of common stock and pre-funded warrants.Conference Call and Webcast InformationChiasma management will host a conference call and webcast to discuss the second quarter results in more detail today, August 10, 2020, at 5:00 pm ET. The dial-in number in the U.S. Canada is 855-327-6837; for international participants, the dial-in number is 631-891-4304. For all callers, please refer to Conference ID 10010555. To access the live webcast, please use the following link: live audio webcast of the call may also be accessed under Events Presentations on the News Investors section of the Companys website, An archived replay of webcast will be available on the Companys website approximately two hours after the event. The archived webcast will be available for one year.MPOWEREDTM Phase 3 TrialChiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the Companys octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED, is a global, randomized, open-label and active-controlled, 15-month trial intended to support approval in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which at least 80 patients who are responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules or injectable somatostatin receptor ligands octreotide LAR or lanreotide autogel, and then followed for an additional nine months. The trial is 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 standard of care injectable somatostatin receptor ligands. Chiasma expects to release top-line data from the MPOWERED Phase 3 clinical trial during the fourth quarter of 2020.About MYCAPSSAINDICATION AND USAGEMYCAPSSA 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.CONTRAINDICATIONSHypersensitivity to octreotide or any of the components of MYCAPSSA. MYCAPSSA can cause a serious allergic reaction including anaphylactic shock.IMPORTANT SAFETY INFORMATIONWarnings and Precautions Gallbladder abnormalities may occur. Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and antidiabetic treatment may need adjustment. Hypothyroidism may occur. Monitor thyroid levels periodically. Bradycardia, arrhythmia or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need adjustment. Decreased vitamin B12 levels and abnormal Schillings tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment.ADVERSE REACTIONSThe 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 INTERACTIONSThe following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, oral hypoglycemic agents, betablockers, bromocriptine. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.PREGNANCYAdvise 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 or full Prescribing Information for MYCAPSSA will be made available at AcromegalyAcromegaly 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. The company estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.About ChiasmaChiasma is commercial-stage 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. 