1. NEEDHAM, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company, today announced that management will present a company overview at the H.C. Wainwright Global Life Sciences Conference, which is being held Tuesday, March 9th - Wednesday, March 10th, 2021.

    The presentation will be available on demand on H.C. Wainwright's conference portal beginning at 7:00 am on Tuesday, March 9th, 2021.

    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…

    NEEDHAM, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company, today announced that management will present a company overview at the H.C. Wainwright Global Life Sciences Conference, which is being held Tuesday, March 9th - Wednesday, March 10th, 2021.

    The presentation will be available on demand on H.C. Wainwright's conference portal beginning at 7:00 am on Tuesday, March 9th, 2021.

    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. In June 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

     

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    com 



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  2. NEEDHAM, Maine, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, today announced that it will host a conference call and live audio webcast on Thursday, March 4, 2021 at 5:00 pm Eastern Time to discuss financial results for the quarter and year ended December 31, 2020 and to provide a business update.

    Conference Call Details

    Thursday, March 4th @ 5:00 pm Eastern Time

    Domestic:877-407-4018
    International:201-689-8471
    Conference ID:13715763
    Webcast:http://public.viavid.com/index.php?id=143291

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An…

    NEEDHAM, Maine, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, today announced that it will host a conference call and live audio webcast on Thursday, March 4, 2021 at 5:00 pm Eastern Time to discuss financial results for the quarter and year ended December 31, 2020 and to provide a business update.

    Conference Call Details

    Thursday, March 4th @ 5:00 pm Eastern Time

    Domestic:877-407-4018
    International:201-689-8471
    Conference ID:13715763
    Webcast:http://public.viavid.com/index.php?id=143291

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of the webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    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. In June 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    617-775-5956

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  3. NEEDHAM, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today announced the hiring of John Doyle as its new Chief Financial Officer, effective today. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities…

    NEEDHAM, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today announced the hiring of John Doyle as its new Chief Financial Officer, effective today. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities to Mr. Doyle. Prior to joining Chiasma, Mr. Doyle served as Vice President of Finance and Investor Relations at Verastem, Inc.

    "It is my pleasure to welcome John to Chiasma, and I believe he will make an immediate impact as we continue to execute on our U.S. commercial launch of MYCAPSSA," stated Raj Kannan, chief executive officer of Chiasma. "John brings an established track record of leadership and success, and I look forward to working with him in realizing the full potential of Chiasma."

    "I would also like to thank Mark Fitzpatrick for his dedicated service to Chiasma since joining the company in 2015. Mark has served in a variety of leadership roles, including as Chief Executive Officer, and his many significant contributions have enabled our potential future success. On behalf of the entire Chiasma team, I wish Mark the very best in his future endeavors," Mr. Kannan added.

    "I was attracted to Chiasma because of the company's unwavering commitment to bring MYCAPSSA to patients in the U.S. and globally, potentially improving the lives of patients suffering from acromegaly," stated Mr. Doyle. "As an early commercial-stage company, I cannot think of a more exciting time to join the Chiasma team, and I look forward to contributing to the company's commercial and financial goals."

    Mr. Doyle joins Chiasma from Verastem, Inc., a publicly traded biopharmaceutical company, where he most recently served as Vice President of Finance and Investor Relations. Prior to joining Verastem in February 2018, he served as Head of Financial Planning & Analysis at SimpliVity Corp., a software company that was acquired by Hewlett Packard Enterprises in February 2017. Before that, Mr. Doyle was Director of Business Unit Financial Planning & Analysis, Early Phase Division, at PAREXEL, a publicly traded pharmaceutical contract research organization. Earlier in his career, he served in increasingly senior financial planning and analysis roles at Hologic, Inc., a publicly traded provider of medical diagnostic, surgical and imaging products. Mr. Doyle holds a B.S. in finance from the University of Massachusetts.

    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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United 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. In June 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 potential commercial success of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties. For a discussion of these risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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.

    Contacts:

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  4. MYCAPSSA® launch in US continuing to gain traction with physicians, patients, and payers

    MYCAPSSA®EMA submission for EU marketing approval on track for mid-2021 following positive results of MPOWERED Phase 3 clinical trial

    NEEDHAM, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today reviewed its 2020 accomplishments and previewed its anticipated 2021 corporate milestones…

    MYCAPSSA® launch in US continuing to gain traction with physicians, patients, and payers

    MYCAPSSA® EMA submission for EU marketing approval on track for mid-2021 following positive results of MPOWERED Phase 3 clinical trial

    NEEDHAM, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today reviewed its 2020 accomplishments and previewed its anticipated 2021 corporate milestones.

    2020 Key Highlights:

    • MYCAPSSA Approved in the U.S. as the first and only oral somatostatin analog (SSA) for the long-term maintenance treatment of patients with acromegaly who responded to and tolerated treatment with octreotide or lanreotide.
      • Approval was based on the positive CHIASMA OPTIMAL Phase 3 trial results which were published in the Journal of Clinical Endocrinology & Metabolism and presented at the 2020 Endocrine Society Annual Meeting (ENDO) along with six other scientific posters relevant to MYCAPSSA.
    • Commercial Launch of MYCAPSSA in the U.S. Late in the third quarter of 2020, Chiasma commenced the initial phase of the MYCAPSSA U.S. commercial launch with a focused salesforce calling on approximately one-third of key prescribing accounts. Chiasma progressed to the second phase of the launch at the beginning of 2021 with an expanded salesforce hired during the fourth quarter of 2020. Progression to the final phase of the launch with a full-strength salesforce is expected after market conditions improve beyond the COVID era.



    • Early launch insights and progress:



      • Coverage of MYCAPSSA by multiple payers insuring approximately 150 million lives provides a solid foundation for MYCAPSSA uptake in 2021.
      • Positive and encouraging feedback on MYCAPSSA from endocrinologists and patients supports the company's goal of ultimately becoming the standard of pharmacological care in acromegaly.
      • Preliminary (unaudited) net revenues for 2020 are expected to be between $0.9 and $1.1 million.  
    • Reported Positive Data from CHIASMA OPTIMAL Open Label Extension. The efficacy and safety (tolerability) seen in the 1-year extension phase of the study (48 weeks) was similar to that seen in the 36-week core study period. The mean of the insulin-like growth factor 1 (IGF-1) levels for the population of all MYCAPSSA treated patients that completed the 36-week core CHIASMA OPTIMAL trial and continued into the open-label extension (OLE) (n=19) was maintained within normal limits at the end of the 48-week OLE period.



    • Reported Positive MPOWERED Phase 3 Topline Data. The MPOWERED study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained IGF-1 response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). The positive clinical trial results provide Chiasma a pathway to pursue regulatory approval of MYCAPSSA in the European Union (EU), further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients with acromegaly.



    • Strengthened Balance Sheet for U.S. Commercial Launch. In April, Chiasma entered into a revenue interest financing agreement with HealthCare Royalty Partners (HCR) for up to $75 million. Also, in July, Chiasma raised approximately $75 million of net proceeds through an underwritten public offering of common stock and pre-funded warrants. Chiasma ended the year with approximately $135 million in cash, cash equivalents and marketable securities (exclusive of approximately $20 million of restricted cash), which is expected to fund its operations as currently planned through at least the end of 2021, including the execution of Chiasma's planned 2021 U.S. MYCAPSSA commercial launch strategy.

    "2020 was the beginning of an important transformation for Chiasma from a company with a strong research and development foundation to a commercial-stage company," stated Raj Kannan, chief executive officer. "We are pleased with the progress of the MYCAPSSA launch to date and the encouraging feedback we have received from physicians, patients and payers. In 2021, we continue to build upon the MYCAPSSA launch in the United States while pursuing MYCAPSSA approval in the European Union. The recently reported positive MPOWERED clinical trial results further support our goal to make MYCAPSSA the new standard of pharmacological care in the long-term maintenance treatment of people with acromegaly."

    Anticipated 2021 Milestones and Related Guidance:

    • Grow MYCAPSSA revenues in the U.S. by building on the progress made with the initial, focused selling effort in the first four months since launch:   Chiasma plans to drive adoption for MYCAPSSA with a broader group of physicians by expanding from a 36-person customer-facing team today to an approximately 45-person customer-facing team as market challenges associated with COVID-19 recede and payer coverage continues to expand.



    • MYCAPSSA EMA Submission. In mid-2021, Chiasma plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking regulatory approval to market MYCAPSSA to patients with acromegaly in the EU.



    • CHIASMA OPTIMAL Open Label Extension Data Oral Presentation at Virtual ENDO 2021. Chiasma plans to present data on longer-term efficacy and safety of MYCAPSSA from the CHIASMA OPTIMAL trial's open-label extension at the virtual 2021 Endocrine Society Annual Meeting (ENDO), which is being held March 20-23.



    • Presentation of MPOWERED Phase 3 Data at Medical Conferences and Publication in a Peer Reviewed Medical Journal. Chiasma expects to present MPOWERED Phase 3 data analyses at upcoming endocrinology scientific meetings in spring and in fall 2021 and submit the results of the MPOWERED trial to a peer-reviewed journal for expected publication in 2021.



    • 2021 Financial Guidance. Operating expense for the full year 2021 is expected to be in a range of $80 million to $90 million, including estimated stock-based compensation expense in a range of $5 million to $6 million. This guidance is based on the company's current U.S. commercial plans and excludes expenditure for potential EU launch preparations of MYCAPSSA and potential additional new product development programs.  

    2021 LifeSci Advisors Corporate Access Event

    Chiasma management will be available to meet with institutional investors and analysts virtually at the 2021 LifeSci Advisors Corporate Access Event on January 7-8 and 11-14.

    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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United 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. In June 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, the commercialization of MYCAPSSA, including efficiency improvements in processes for prescriptions and delivery of commercial product, the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care and the anticipated market acceptance and third-party reimbursement of and access to MYCAPSSA, the expansion of the customer-facing team, the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, the presentation and publication plans for the data from the MPOWERED trial, and the company's financial guidance, including operating expense and cash runway guidance. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA or EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, the company's ability to retain requisite regulatory approvals for the commercial sale of MYCAPSSA in the United States, the timing and costs involved in establishing and maintaining a commercial organization and launching the sale of MYCAPSSA, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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.

    Contacts:

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

     



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  5. NEEDHAM, Mass., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced that management will be presenting and participating in investor meetings at both the Piper Sandler Healthcare Conference as well as the Evercore ISI HealthCONx Conference. Details for each conference are as follows:

    Piper Sandler Healthcare Conference:
    Date:Monday, November 23, 2020 *
    Time:10:00am ET
    Format:
    Fireside Chat

    * All presentations for the Piper Sandler Healthcare Conference will be available on Piper Sandler's conference

    NEEDHAM, Mass., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced that management will be presenting and participating in investor meetings at both the Piper Sandler Healthcare Conference as well as the Evercore ISI HealthCONx Conference. Details for each conference are as follows:

    Piper Sandler Healthcare Conference:
    Date:Monday, November 23, 2020 *
    Time:10:00am ET
    Format:

    Fireside Chat

    * All presentations for the Piper Sandler Healthcare Conference will be available on Piper Sandler's conference portal at 10:00 am on Monday, November 23. Actual dates for the conference are November 30 – December 3.

    Evercore ISI HealthCONx Conference:
    Date:Thursday, December 3, 2020
    Time:1:00pm ET
    Format:Panel Discussion, "Easy Pills to Swallow: Oral Drugs for Large Endo Markets" - Chiasma, Crinetics and Lumos

    A live audio webcast of each of the two events may be accessed under "Events & Presentations" on the News and Investors section of Chiasma's website at https://ir.chiasma.com/events-presentations. A replay will be available for 90 days.

    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. On June 26, 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 in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  6. NEEDHAM, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced that it will host an expert panel on acromegaly and the results from its recently completed MPOWERED® Phase 3 clinical trial on Monday, November 30, 2020 at 11:00 am Eastern Time.

    The call will feature presentations by Key Opinion Leader (KOL) Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, who will discuss the topline data from Chiasma's Phase 3 MPOWERED study as well as the unmet medical need in acromegaly…

    NEEDHAM, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced that it will host an expert panel on acromegaly and the results from its recently completed MPOWERED® Phase 3 clinical trial on Monday, November 30, 2020 at 11:00 am Eastern Time.

    The call will feature presentations by Key Opinion Leader (KOL) Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, who will discuss the topline data from Chiasma's Phase 3 MPOWERED study as well as the unmet medical need in acromegaly and the treatment burden that patients experience with monthly somatostatin analog injections. Additionally, a renowned patient advocate and Acromegaly Community President Jill Sisco will discuss the patient experience switching to MYCAPSSA®. Dr. Fleseriu and Ms. Sisco will be available to answer questions following the formal presentations.

    Chiasma's management team will also provide an overview of the MPOWERED Phase 3 topline data, which were announced on November 18th. MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared with injections – Evaluation of REsponse Durability), was a global, randomized, non-inferiority, open-label, and active-controlled 15-month trial that was designed to support a potential marketing application of MYCAPSSA® in the European Union.

    This event is intended for institutional investors, sell-side analysts, and business development professionals only.  To register for the call, please click here.

    Maria Fleseriu, MD, FACE is a Professor of Medicine and Neurological Surgery and Director of the Pituitary Center at Oregon Health and Science University in Portland, Oregon and Immediate Past President of the Pituitary Society. Dr. Fleseriu has a long-standing clinical and research interest in the pathophysiology and treatment of pituitary and adrenal disorders. She is a frequent plenary guest speaker at national and international meetings on treatment of Cushing's, acromegaly and growth hormone deficiency, is global principal investigator in clinical trials, and has authored over 170 manuscripts in prestigious journals, including guidelines, consensus papers and book chapters.

    Dr. Fleseriu has been awarded the title of "Doctor Honors Causa" by the University of Medicine and Pharmacy "Carol Davila" Bucharest, she serves on the Board of Directors and chairs Physician Education Committee for Pituitary Society, she serves on several committees for the Endocrine Society, Pituitary Society, and American Association of Clinical Endocrinology and she is past chair of the Endocrine Society Guidelines Committee and the Hypopituitarism task force.

    Dr. Fleseriu is Chief Editor of Pituitary Endocrinology for Frontiers in Endocrinology, Section Head for Pituitary and Neuroendocrine F 1000, Associate Editor for European Journal of Endocrinology, Reviews in Endocrinology and Metabolism, Senior Editor for Endocrinology, Diabetes and Metabolism CR and a member of the editorial board of Pituitary. She has been involved in leadership positions of educational programs sponsored by the Endocrine Society, the Pituitary Society, and patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has served on multiple scientific advisory boards for biotechnology and pharmaceutical companies and participated in study design and has been global principal investigator for several Cushing's and acromegaly studies.

    Dr. Fleseriu received her medical degree from the University of Medicine and Pharmacy, Timisoara, Romania and completed endocrinology training at University Hospital Sibiu, National Institute of Endocrinology "C.I Parhon" (with focus on pituitary disorders), Romania and Centre Hospitalier Luxembourg in Luxembourg. She pursued additional residency in internal medicine at Case Western Reserve University and an endocrinology fellowship at Cleveland Clinic in USA.

    Jill Sisco is President of Acromegaly Community, Inc., a patient organization that helps educate patients and loved ones regarding this rare disease and provides guidance on how to cope with their difficult illness. Since her diagnosis in 2005, Jill has been an influential advocate towards a better quality of life for Acromegaly patients worldwide. In 2008, Jill became a leader in patient advocacy and has sat on several Acromegaly advisory boards. Jill has presented the patient perspective to FDA, co-authored several medical journal articles and abstracts regarding Acromegaly, and manages the widely visited patient community website and social media support groups. By organizing and hosting the biennial International Acromegaly Community Conference which engages patients, specialists, and pharmaceutical companies, Jill shows how passionate she is about providing an emotional and communal support network for people touched by acromegaly. She works tirelessly to enable forward thinking that will facilitate research, assist patients with their treatment plans, and provide positive outcomes for the future of acromegaly patients everywhere. Jill is highly respected in her community and has been a pioneer in building awareness around Acromegaly. Through her dedication, Jill leads by example and is a proponent of patients taking control of their lives and their disease and advocating for their best health possible.

    MPOWERED™ Phase 3 Clinical Trial

    The MPOWERED trial was a global, non-inferiority, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United 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. On June 26, 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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 Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  7. 91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial

    Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021

    Company to host conference call today at 8:00 a.m. ET

    NEEDHAM, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced positive top-line data from its global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA® (oral octreotide capsules) to long-acting injectable somatostatin…

    91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial

    Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021

    Company to host conference call today at 8:00 a.m. ET

    NEEDHAM, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced positive top-line data from its global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA® (oral octreotide capsules) to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support a planned marketing authorization application for MYCAPSSA in the European Union. MYCAPSSA is currently approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

    The MPOWERED non-inferiority trial was designed to compare long-term maintenance treatment with MYCAPSSA, the first and only approved oral SSA therapy for acromegaly, to the long-acting injectables octreotide long-acting release and lanreotide autogel, in patients previously responding to these therapies. After a six-month run-in phase, 92 patients who were responders to MYCAPSSA were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy.

    Key Results:

    • The study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained insulin-like growth factor 1 (IGF-1) response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month randomized, controlled treatment (RCT) phase.
    • MYCAPSSA maintained mean IGF-1 within normal limits and was comparable to injectable therapy: mean IGF-1 in the MYCAPSSA cohort at the beginning and end of the RCT phase was 0.9 × ULN and 0.9 × ULN, respectively, compared to 0.8 × ULN and 0.8 × ULN, respectively, in the injectable SSA cohort.

    "We are excited with the positive results from the MPOWERED study that demonstrated non-inferiority relative to long-acting SSAs. These results further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients with acromegaly," said Raj Kannan, chief executive officer of Chiasma. "In light of these positive results, we plan to submit a marketing authorization application for MYCAPSSA to the European Medicines Agency in mid-2021. While we are excited to report the preliminary top line results, further analyses of the trial results are ongoing, and we plan to present the full data set from the study at upcoming medical conferences in 2021."

    "I am pleased that the MPOWERED study met its primary endpoint of non-inferiority compared to long acting SSA injectables. These results should provide treating physicians with confidence that patients on injectables who are switched to oral octreotide can be expected to achieve comparable efficacy and safety," commented Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, Professor of Medicine and Neurological Surgery, Director of the Pituitary Center at Oregon Health and Science University in Portland, Oregon, Immediate Past President of the Pituitary Society. "Many patients with acromegaly experience significant burdens with SSA injections, including injection site pain and reactions, and I believe that the results of the MPOWERED study underscore the importance of an oral treatment alternative for patients with acromegaly."

    MPOWERED MYCAPSSA® Safety:

    The safety profile of MYCAPSSA capsules in the MPOWERED trial was consistent with the known safety profile of octreotide but without adverse injection site reactions. No new or unexpected safety signals were detected during the study among MYCAPSSA subjects. See Important Safety Information below for contraindications, warnings, precautions and adverse reactions associated with MYCAPSSA based in the current approved labeling in the United States.

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the results of the MPOWERED study today, November 18, 2020, at 8:00 a.m. ET. The dial-in number in the U.S. / Canada is 877-407-4018; for international participants, the dial-in number is 201-689-8471. For all callers, please refer to Conference ID 13713200. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=142448

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    MPOWERED™ Phase 3 Trial Design

    The MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients who 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 long-acting release 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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United 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. On June 26, 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 in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, statements regarding the timing of an MAA submission and regulatory review, statements regarding the company's plans for the presentation of the full trial results, statements regarding the company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, and statements concerning the therapeutic potential of MYCAPSSA, including its ability to become a standard of care. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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 the company undertakes no duty to update this information unless required by law.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  8. NEEDHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced that management will be participating in the Jefferies Virtual London Healthcare Conference, which is being held November 17-19. Details of the presentation are as follows:

    Date:Thursday, November 19, 2020
    Time:2:55pm ET
    Format:Fireside chat

    A live audio webcast of the Jefferies fireside chat will be available in the News and Investors section of Chiasma's website at www.chiasma.com. A replay will be available for 90 days.

    About Chiasma

    NEEDHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced that management will be participating in the Jefferies Virtual London Healthcare Conference, which is being held November 17-19. Details of the presentation are as follows:

    Date:Thursday, November 19, 2020
    Time:2:55pm ET
    Format:Fireside chat

    A live audio webcast of the Jefferies fireside chat will be available in the News and Investors section of Chiasma's website at www.chiasma.com. A replay will be available for 90 days.

    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. On June 26, 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 in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

     



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  9. Launched MYCAPSSA® in U.S. earlier than expected and recognized first net product revenues in September

    Well capitalized to support the MYCAPSSA launch

    On track to announce MPOWERED Phase 3 trial topline data this month

    Company to host conference call today, November 5, 2020 at 5:00pm ET

    NEEDHAM, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced financial results for the third quarter ended September 30, 2020 and provided an update on its recent phased launch of MYCAPSSA® in the United…

    Launched MYCAPSSA® in U.S. earlier than expected and recognized first net product revenues in September

    Well capitalized to support the MYCAPSSA launch

    On track to announce MPOWERED Phase 3 trial topline data this month

    Company to host conference call today, November 5, 2020 at 5:00pm ET

    NEEDHAM, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), 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 on burdensome and painful injections, today announced financial results for the third quarter ended September 30, 2020 and provided an update on its recent phased launch of MYCAPSSA® in the United States as the first and only oral somatostatin analog for the maintenance treatment of people with acromegaly.

    Recent Business Highlights and Upcoming Milestones

    • Launched MYCAPSSA in September, the first and only oral somatostatin analog (SSA) with the potential to become the new standard of pharmacological care in the long-term maintenance treatment of patients with acromegaly;
    • Announced publication of CHIASMA OPTIMAL Phase 3 clinical trial results in the prestigious Journal of Clinical Endocrinology & Metabolism;
    • Continued to enroll patients in the MACRO registry, the first ever industry-sponsored acromegaly disease state registry in the United States;
    • Exited the third quarter with $177.1 million of cash, cash equivalents, marketable securities and restricted cash; and
    • MPOWERED Phase 3 clinical trial topline data expected later this month that, if positive, are expected to provide head-to-head data against injectable octreotide and lanreotide and support a planned regulatory submission for MYCAPSSA for the treatment of acromegaly in the European Union.

    "I am pleased that we were able to launch MYCAPSSA earlier than expected. I commend the dedicated team at Chiasma for the launch progress we have made to date. During this initial phase, our customer-facing team has made solid progress reaching targeted healthcare providers, generating patient enrollment forms, and gaining access for MYCAPSSA with payers," stated Raj Kannan, chief executive officer of Chiasma. "As expected, and incorporated into our phased launch plans, headwinds from COVID-19 continue to be challenging; however, we expect strong revenue growth in the fourth quarter of 2020 and beyond."

    Third Quarter 2020 Financial Results

    Product Revenues, Net: Net product revenues were approximately $142,000 in the third quarter of 2020, net of sales discounts and allowances, related to MYCAPSSA sales following the early-September launch. As is common in rare disease markets with specialized products, healthcare providers initiate a MYCAPSSA prescription by sending a consented patient enrollment form into our dedicated, in-house patient services group, for which the processing time may be up to six weeks or more to convert to a revenue generating patient.   Nonetheless, we anticipate that by the end of 2020 over 100 million lives in the United States will be covered on formulary for MYCAPSSA which we believe has the potential to reduce the length of time in converting prescriptions to revenue generating patients.

    SG&A Expenses: Selling, general and administrative expenses were $13.0 million for the third quarter ended September 30, 2020, compared with $4.1 million for the same period of 2019. The current year results include $6.6 million of commercial activities, an increase in compensation-related expenses, and increased other administrative costs to support the commercialization of MYCAPSSA in the United States.

    R&D Expenses: Research and development expenses were $4.5 million for the third quarter ended September 30, 2020, compared with $4.1 million for the same period of 2019. The increase in current period results was primarily driven by costs associated with our MACRO registry and increased regulatory costs.

    Net Loss: For the quarter ended September 30, 2020, net loss was ($18.5) million, or ($0.30) per basic share, compared with ($7.7) million, or ($0.20) per basic share, in the same period of 2019.

    Cash Position: Chiasma ended the third quarter with cash, cash equivalents, marketable securities and restricted cash of $177.1 million, compared with $92.4 million as of December 31, 2019. In July and September, the company received an additional $25 million and $15 million, respectively, through our revenue interest finance agreement with Healthcare Royalty Partners, triggered by the FDA approval and first commercial sale of MYCAPSSA, respectively. Additionally, as previously announced in July, Chiasma raised approximately $75 million in net proceeds from our underwritten public offering of common stock and pre-funded warrants.

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss its third quarter results in more detail today, November 5, 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 10011435. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=141919

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    MPOWERED™ Phase 3 Clinical Trial

    Chiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the Company's 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 92 patients who were deemed 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 in November 2020.

    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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United 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. On June 26, 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding the commercialization of MYCAPSSA, including its reimbursement and market adoption, statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care and the anticipated market acceptance of and access to MYCAPSSA, statements concerning the success of a commercial launch of MYCAPSSA in the United States, statements regarding the company's expectations regarding formulary coverage for MYCAPSSA, statements regarding the release of top-line results from the MPOWERED Phase 3 trial and potential for regulatory filings based on those results, and statements regarding the company's commercial organization and efforts and potential sales and revenue growth. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the manufacturing supplements to the company's approved new drug application, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture active pharmaceutical ingredient and commercial octreotide capsules, the company's ability to retain requisite regulatory approvals for the commercial sale of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization and launching the sale of MYCAPSSA, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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 Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932





    Chiasma, Inc.  
    Condensed Consolidated Statements of Operations  
    (amounts in thousands except share and per share data) 
    (unaudited) 
             
     For the three months ended For the nine months ended 
     September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019 
    Product revenue, net$142  $  $142  $  
    Cost of goods sold 3      3     
    Gross Profit 139      139     
    Operating expenses:        
    Selling, general and administrative 13,048   4,116   31,295   9,210  
    Research and development 4,523   4,110   22,320   16,103  
    Total operating expenses 17,571   8,226   53,615   25,313  
    Loss from operations (17,432)  (8,226)  (53,476)  (25,313) 
    Interest and other income, net 1,122   549   1,648   1,074  
    Interest expense (2,126)     (3,033)    
    Loss before income taxes (18,436)  (7,677)  (54,861)  (24,239) 
    Provision for income taxes 21   6   110   34  
    Net loss$(18,457) $(7,683) $(54,971) $(24,273) 
             
    Earnings per share of common stock:        
         Basic$(0.30) $(0.20) $(1.13) $(0.77) 
         Diluted$(0.30) $(0.20) $(1.13) $(0.77) 
             
    Weighted-average shares outstanding:        
         Basic 61,459,491   38,490,768   48,685,024   31,569,731  
         Diluted 61,459,491   38,490,768   48,685,024   31,569,731  
             





    Chiasma, Inc.  
    Condensed Consolidated Balance Sheets Information 
    (amounts in thousands)  
    (unaudited) 
         
     September 30, 2020 December 31, 2019 
         
    Cash and cash equivalents$72,840 $27,855 
    Marketable securities 83,917  64,520 
    Accounts receivable 179  - 
    Inventory 8,942  - 
    Prepaid expenses and other current assets 5,383  3,881 
    Property and equipment, net 581  334 
    Other assets 2,419  2,236 
    Restricted cash 20,300  - 
    Total assets$194,561 $98,826 
         
    Accounts payable$7,149 $3,253 
    Accrued expenses 10,275  7,576 
    Other current liabilities 722  546 
    Deferred royalty obligation 63,529  - 
    Long-term liabilities 2,548  1,682 
    Total liabilities 84,223  13,057 
    Total stockholders' equity 110,338  85,769 
    Total liabilities and stockholders' equity$194,561 $98,826 
         

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  10. NEEDHAM, Mass., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA) today recognizes Acromegaly Awareness Day, which is observed every year on November 1, and reiterates its commitment to people with acromegaly and the patient advocacy groups in their ongoing efforts to increase awareness of acromegaly and support the unique needs of people living with acromegaly.

    Chiasma will also host a Facebook Live event on Sunday, November 1 at 4:00pm ET titled, "5 Tips to Achieve Effective Communications with Healthcare Teams." This live event will be moderated by Jill Sisco, president of Acromegaly Community. Jill will be joined by Chris Yedinak, DNP, FNP-BC, MN, RN, grad DipEd., assistant professor, Department of Neurological Surgery at…

    NEEDHAM, Mass., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA) today recognizes Acromegaly Awareness Day, which is observed every year on November 1, and reiterates its commitment to people with acromegaly and the patient advocacy groups in their ongoing efforts to increase awareness of acromegaly and support the unique needs of people living with acromegaly.

    Chiasma will also host a Facebook Live event on Sunday, November 1 at 4:00pm ET titled, "5 Tips to Achieve Effective Communications with Healthcare Teams." This live event will be moderated by Jill Sisco, president of Acromegaly Community. Jill will be joined by Chris Yedinak, DNP, FNP-BC, MN, RN, grad DipEd., assistant professor, Department of Neurological Surgery at N.W. Pituitary Center, Oregon Health & Sciences University in Portland Oregon, and Elaine, a patient living with acromegaly. The public is encouraged to watch and use the hashtag #AskAboutAcromegaly to show their support. The event will be accessible via the link: https://www.facebook.com/MYCAPSSA

    "We are proud to continue our unwavering commitment to people with acromegaly and advocacy groups working to help raise awareness of the significant burdens that patients and their families bear each day," said Raj Kannan, chief executive officer of Chiasma. "This Acromegaly Awareness Day, we reflect on the years of research and innovation that have made it possible for Chiasma to offer a new oral therapeutic option for patients in the United States. At the same time, we are continuing our development work with the goal of making this novel oral therapy available to acromegaly patients worldwide."

    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 in the United 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. On June 26, 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  11. NEEDHAM, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, today announced that it will host a conference call and live audio webcast on Thursday, November 5, 2020 at 5:00 pm Eastern Time to discuss financial results for the quarter ended September 30, 2020 and to provide a business update.

    Conference Call Details

    Thursday, November 5th @ 5:00 pm Eastern Time

    Domestic:855-327-6837
    International:631-891-4304
    Conference ID:10011435
    Webcast: http://public.viavid.com/index.php?id=141919

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations

    NEEDHAM, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, today announced that it will host a conference call and live audio webcast on Thursday, November 5, 2020 at 5:00 pm Eastern Time to discuss financial results for the quarter ended September 30, 2020 and to provide a business update.

    Conference Call Details

    Thursday, November 5th @ 5:00 pm Eastern Time

    Domestic:855-327-6837
    International:631-891-4304
    Conference ID:10011435
    Webcast: http://public.viavid.com/index.php?id=141919

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    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. On June 26, 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    617-775-5956

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  12. NEEDHAM, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to reduce the burden of chronic injections for people with rare diseases, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for treatment of acromegaly, today announced that Mark Fitzpatrick intends to step down as President and Principal Financial Officer. The company plans to initiate an executive search to identify Mr. Fitzpatrick's successor. To ensure a smooth transition, Mr. Fitzpatrick has agreed to remain in his current position until June 30, 2021 or the company's appointment of its next chief…

    NEEDHAM, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to reduce the burden of chronic injections for people with rare diseases, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for treatment of acromegaly, today announced that Mark Fitzpatrick intends to step down as President and Principal Financial Officer. The company plans to initiate an executive search to identify Mr. Fitzpatrick's successor. To ensure a smooth transition, Mr. Fitzpatrick has agreed to remain in his current position until June 30, 2021 or the company's appointment of its next chief financial officer, if earlier.

    "On behalf of the Board of Directors and the management team, I thank Mark for his significant contributions to Chiasma," said Raj Kannan, chief executive officer at Chiasma. "Under Mark's prior leadership as President and CEO of the Company from late 2016 until my appointment as CEO in June 2019, the company skillfully navigated its way forward from its 2016 regulatory setback to the release of positive CHIASMA OPTIMAL Phase 3 trial data for oral octreotide capsules in patients with acromegaly. Since I joined Chiasma, Mark has closely partnered with me and the organization on key initiatives, most notably the FDA approval of our new drug application for MYCAPSSA® and subsequent initial phases of our commercial launch."

    Mr. Kannan continued, "With Chiasma's recent achievement of several major milestones and transition to a commercial stage company, the company and Mark believe the time is right to initiate this transition and identify a new chief financial officer for Chiasma. We believe Chiasma's management team has been significantly broadened and strengthened over the past year and we are well capitalized helping to ensure what we expect will be a smooth transition with Mark."

    "For more than five years, it has been an honor for me to be a member of this talented team, and I am immensely proud of our efforts to overcome adversity, stay the course, and advance MYCAPSSA to FDA approval and availability to patients," said Mark Fitzpatrick. "With these significant milestones now accomplished and the human and financial capital now in place to execute our U.S. commercial launch, it is a natural time for Chiasma to welcome new financial leadership as I explore the next chapter in my career. I am confident that Chiasma is in an excellent position to deliver on the potential of MYCAPSSA, and I look forward to continue working with Raj and the leadership team over the coming months to ensure a smooth transition."

    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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United 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. On June 26, 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 in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's transition plans for Mr. Fitzpatrick and the company's ability to identify and hire a chief financial officer. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the impact of the management transition and our ability to recruit and retain highly skilled personnel. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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 Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

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  13. NEEDHAM, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced that management will be participating in two investor conferences in September.

    Presentation details:

    Event: HC Wainwright Virtual 22nd Annual Global Investment Conference
    Format: Fireside chat
    Date: Monday, September 14, 2020
    Time: 1:00pm EDT

    Event: Cantor Virtual Global Healthcare Conference
    Format: Fireside chat
    Date: Wednesday, September 16, 2020
    Time: 11:20am EDT

    A live audio webcast of both sessions will be available in the News and Investors section…

    NEEDHAM, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced that management will be participating in two investor conferences in September.

    Presentation details:

    Event: HC Wainwright Virtual 22nd Annual Global Investment Conference

    Format: Fireside chat

    Date: Monday, September 14, 2020

    Time: 1:00pm EDT

    Event: Cantor Virtual Global Healthcare Conference

    Format: Fireside chat

    Date: Wednesday, September 16, 2020

    Time: 11:20am EDT

    A live audio webcast of both sessions will be available in the News and Investors section of Chiasma's website at www.chiasma.com. A replay of both sessions will be available for 90 days. 

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  14. NEEDHAM, Mass., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced the commercial launch and availability of MYCAPSSA® (octreotide) capsules in the United States for patients with acromegaly. MYCAPSSA, the first and only oral somatostatin analog (SSA), was approved by the U.S. Food and Drug Administration (FDA) on June 26, 2020 for the long-term maintenance treatment of patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.   

    "I am proud of our employees' tireless efforts to achieve…

    NEEDHAM, Mass., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced the commercial launch and availability of MYCAPSSA® (octreotide) capsules in the United States for patients with acromegaly. MYCAPSSA, the first and only oral somatostatin analog (SSA), was approved by the U.S. Food and Drug Administration (FDA) on June 26, 2020 for the long-term maintenance treatment of patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.   

    "I am proud of our employees' tireless efforts to achieve the earlier-than-expected U.S. commercial launch of MYCAPSSA, the first and only oral SSA in an injectable dominated market," stated Raj Kannan, chief executive officer of Chiasma. "We are  executing on our plan to make MYCAPSSA widely available to potentially address the strong preference by patients with acromegaly for an oral, non-medically administered therapy."

    Anand Varadan, chief commercial officer of Chiasma, commented, "To support our launch of MYCAPSSA in the U.S., we have trained and deployed the first wave of what we believe is a world class sales team experienced in specialty, orphan diseases.  Our team has been in the field since late July and we believe it is sized for and possesses the capabilities to operate in the current, predominantly remote environment. We plan to expand our customer-facing team as our commercial launch progresses and as we see the level of in-person interactions with healthcare providers increase. The initial feedback on MYCAPSSA from healthcare providers has been encouraging and we are continuing to engage with them to establish the foundation needed to execute a robust launch of MYCAPSSA."

    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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United States.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 commercial launch and availability of MYCAPSSA, statements concerning the commercial or therapeutic potential of MYCAPSSA, the anticipated market acceptance of and access to MYCAPSSA, and statements concerning capabilities of our sales team and the potential hiring of additional customer-facing employees. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the acceptance of MYCAPSSA in the commercial marketplace, the timing and costs involved in establishing a commercial organization, Chiasma's ability to obtain and maintain necessary regulatory approvals, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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 Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  15. NEEDHAM, Mass., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced the online publication of its CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) Phase 3 clinical trial results in the prestigious endocrinologist-focused Journal of Clinical Endocrinology & Metabolism. The publication, entitled, "Maintenance of acromegaly control in patients switching from injectable somatostatin receptor ligands to oral octreotide therapy," was lead authored by Susan Samson, M.D., Ph.D., FRCPC, FACE, who served…

    NEEDHAM, Mass., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced the online publication of its CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) Phase 3 clinical trial results in the prestigious endocrinologist-focused Journal of Clinical Endocrinology & Metabolism. The publication, entitled, "Maintenance of acromegaly control in patients switching from injectable somatostatin receptor ligands to oral octreotide therapy," was lead authored by Susan Samson, M.D., Ph.D., FRCPC, FACE, who served as principal investigator of the CHIASMA OPTIMAL clinical trial.

    "We are honored that the results from our Phase 3 CHIASMA OPTIMAL trial will be published in the Journal of Clinical Endocrinology & Metabolism," said William Ludlam, M.D., Ph.D., senior vice president of clinical development and medical affairs at Chiasma. "This publication in a top tier respected journal provides validation in the scientific community of our pivotal study results and the potential benefits MYCAPSSA® could bring to patients with acromegaly.  We would like to thank the authors, investigators, staff and, most importantly, patients that participated in this study for their help in bringing a novel, non-injectable oral option to those living with acromegaly."

    The CHIASMA OPTIMAL trial (NCT03252353) was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial to evaluate the efficacy and safety of MYCAPSSA (octreotide) capsules in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin analogs (SSA), namely octreotide LAR or lanreotide depot. The trial enrolled 56 adult patients whose disease was biochemically controlled by SSA therapy based upon levels of IGF-1, a byproduct of increased growth hormone (GH), caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). Patients were randomized on a 1:1 basis, to MYCAPSSA or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening).

    Results from the study demonstrated that average IGF-1 levels were within the normal range (0.97 X upper limit of normal (ULN)) for all patients receiving MYCAPSSA at the end of the treatment compared to patients receiving placebo (1.69 X ULN). Growth hormone levels were maintained (< 2.5 ng/mL) in 77.7% of the MYCAPSSA group versus 30.4% in the placebo group (P=0.0007). Patients in the MYCAPSSA group, 75% (21/28) successfully completed the trial after 36 weeks and did not require reversion to prior injectable treatment. Most patients that reverted to injectable SSA re-established their baseline response levels after a single dose of injectable SSA suggesting that, in the clinical setting, those patients who fail to respond on treatment with MYCAPSSA may be able to quickly and safely revert to prior therapy, if necessary. The data from the study demonstrated that MYCAPSSA was well tolerated, and no new or unexpected safety signals were observed.

    The full pre-print publication can be accessed at:

    https://academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgaa526/5892992

    In June 2020, the U.S. Food and Drug Administration (FDA) approved MYCAPSSA for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog approved by the FDA and the first product approved by the FDA utilizing Chiasma's Transient Permeability Enhancer (TPE®) technology.

    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 B12 levels 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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United States.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 commercial or therapeutic potential of MYCAPSSA and the anticipated market acceptance of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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 Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  16. MYCAPSSA® U.S. commercial launch planned for the fourth quarter

    On track to announce MPOWERED Phase 3 trial topline data in the fourth quarter

    Company to host conference call today, August 10, at 5pm ET

    NEEDHAM, 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…

    MYCAPSSA® U.S. commercial launch planned for the fourth quarter

    On track to announce MPOWERED Phase 3 trial topline data in the fourth quarter

    Company to host conference call today, August 10, at 5pm ET

    NEEDHAM, 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 MPOWERED™ 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 FDA's 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

    • G&A 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.
    • R&D 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 Information

    Chiasma 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: http://public.viavid.com/index.php?id=141033

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    MPOWERED™ Phase 3 Trial

    Chiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the Company's 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 MYCAPSSA

    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. MYCAPSSA can cause a serious allergic reaction including anaphylactic shock.

    IMPORTANT SAFETY INFORMATION

    Warnings 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 Schilling's tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment.

    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, oral hypoglycemic agents, beta‑blockers, 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.

    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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA will be made available at www.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. The company estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding plans for and the commercialization of MYCAPSSA, statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care, and the anticipated market acceptance of MYCAPSSA, statements regarding the data from the open label extension of the CHIASMA OPTIMAL trial, statements regarding the company's expectations relating to the manufacturing supplement it submitted to the FDA and the company's expectations regarding the availability of product supply, statements concerning the timing and success of a potential commercial launch of MYCAPSSA in the United States, and statements regarding the release of top-line results from the MPOWERED Phase 3 trial and potential for regulatory filings based on those results. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the manufacturing supplement to the NDA the company submitted to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture active pharmaceutical ingredient and commercial octreotide capsules, the company's ability to retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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 Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    617-775-5956

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932





    Chiasma, Inc.  
    Condensed Consolidated Statements of Operations  
    (amounts in thousands except share and per share data) 
    (unaudited) 
             
     For the three months ended For the six months ended 
     June 30, 2020 June 30, 2019 June 30, 2020 June 30, 2019 
    Operating expenses:        
    General and administrative$10,665  $2,644  $18,247  $5,094  
    Research and development 9,672   5,522   17,797   11,993  
    Total operating expenses 20,337   8,166   36,044   17,087  
    Loss from operations (20,337)  (8,166)  (36,044)  (17,087) 
    Interest and other income, net 128   341   526   525  
    Interest expense (907)     (907)    
    Loss before income taxes (21,116)  (7,825)  (36,425)  (16,562) 
    Provision for income taxes 12   15   89   28  
    Net loss$(21,128) $(7,840) $(36,514) $(16,590) 
             
    Earnings per share of common stock:        
      Basic$(0.50) $(0.25) $(0.86) $(0.59) 
      Diluted$(0.50) $(0.25) $(0.86) $(0.59) 
             
    Weighted-average shares outstanding:        
      Basic 42,267,507   31,597,698   42,227,601   28,051,856  
      Diluted 42,267,507   31,597,698   42,227,601   28,051,856  
             





    Chiasma, Inc.  
    Condensed Consolidated Balance Sheets Information 
    (amounts in thousands)  
    (unaudited) 
         
     June 30, 2020 December 31, 2019 
         
    Cash and cash equivalents$52,194 $27,855 
    Marketable securities 14,893  64,520 
    Prepaid expenses and other current assets 3,741  3,881 
    Property and equipment, net 617  334 
    Other assets 2,521  2,236 
    Restricted cash 20,000  - 
    Total assets$93,966 $98,826 
         
    Accounts payable$7,079 $3,253 
    Accrued expenses 8,148  7,576 
    Other current liabilities 716  546 
    Deferred royalty obligation 24,601  - 
    Long-term liabilities 1,444  1,682 
    Total liabilities 41,988  13,057 
    Total stockholders' equity 51,978  85,769 
    Total liabilities and stockholders' equity$93,966 $98,826 
         









                                          

     

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  17. NEEDHAM, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, today announced that it will host a conference call and live audio webcast on Monday, August 10, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter ended June 30, 2020 and to provide a business update.

    Conference Call Details

    Monday, August 10th @ 5pm Eastern Time

    Domestic:855-327-6837
    International:631-891-4304
    Conference ID:10010555
    Webcast:http://public.viavid.com/index.php?id=141033

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of the…

    NEEDHAM, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, today announced that it will host a conference call and live audio webcast on Monday, August 10, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter ended June 30, 2020 and to provide a business update.

    Conference Call Details

    Monday, August 10th @ 5pm Eastern Time

    Domestic:855-327-6837
    International:631-891-4304
    Conference ID:10010555
    Webcast:http://public.viavid.com/index.php?id=141033

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of the webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    617-775-5956

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

    View Full Article Hide Full Article
  18. -- The mean of the IGF-1 levels for the population of all MYCAPSSA treated patients that completed the 36-week core CHIASMA OPTIMAL trial and continued into the open-label extension (OLE) (n=19) was maintained within normal limits at the end of the 48-week OLE period --

    -- All MYCAPSSA responders (IGF-1 within normal limits) who enrolled into the OLE completed the 48-week period; 93% maintained their response at the end of this period --

    NEEDHAM, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced 48-week, open-label efficacy…

    -- The mean of the IGF-1 levels for the population of all MYCAPSSA treated patients that completed the 36-week core CHIASMA OPTIMAL trial and continued into the open-label extension (OLE) (n=19) was maintained within normal limits at the end of the 48-week OLE period --

    -- All MYCAPSSA responders (IGF-1 within normal limits) who enrolled into the OLE completed the 48-week period; 93% maintained their response at the end of this period --

    NEEDHAM, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced 48-week, open-label efficacy and safety data from the Phase 3 CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) open-label extension (OLE) study of MYCAPSSA® (octreotide) capsules.

    "We are excited to see in the OLE data that MYCAPSSA, the only FDA-approved oral somatostatin analog, maintained insulin-like growth factor 1 (IGF-1) levels within normal limits for an additional 48-weeks following the completion of the 36-week CHIASMA OPTIMAL Phase 3 clinical trial," said William Ludlam, M.D., Ph.D., senior vice president of clinical development and medical affairs at Chiasma. "All MYCAPSSA responders that entered into the OLE study continued to take MYCAPSSA after an additional 48 weeks, providing further evidence of patient satisfaction and preference for this recently approved oral treatment option."

    The OLE study, which is still ongoing, is examining the longer-term safety and efficacy of MYCAPSSA in patients who participated in our Phase 3 CHIASMA OPTIMAL clinical trial. Key findings from the OLE at 48-weeks include:

    • The mean of the IGF-1 levels for the population of all MYCAPSSA treated patients that completed the 36-week, double-blind placebo controlled (DPC) CHIASMA OPTIMAL trial and continued into the OLE (n=19) was maintained within normal limits at the end of the 48-week OLE period.



    • 90% of patients enrolled into the OLE that were treated with MYCAPSSA during the DPC phase of the study (n=20) completed the 48-week OLE period.



    • All patients that enrolled into the OLE as responders to MYCAPSSA (IGF-1 within normal limits, n=14) completed the 48-week OLE period and 93% maintained their response within the normal limits at the end of this period.



    • The safety profile observed during OLE was generally consistent with the safety of MYCAPSSA noted in the 36-week CHIASMA OPTIMAL trial with no new patterns noted with the increased duration of exposure.

    Raj Kannan, chief executive officer of Chiasma, added, "these longer term data reaffirm our belief in the potential for MYCAPSSA to be the new standard of pharmacological care for patients with acromegaly who face significant challenges with their octreotide and lanreotide injectables."

    In June 2020, the U.S. Food and Drug Administration (FDA) approved MYCAPSSA for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog approved by the FDA and the first product approved by the FDA utilizing Chiasma's Transient Permeability Enhancer (TPE®) technology.

    CHIASMA OPTIMAL Global Phase 3 Trial

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a special protocol assessment (SPA) agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (octreotide or lanreotide) based upon levels of IGF-1, a byproduct of increased growth hormone (GH), levels caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening). Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring reversion to prior treatment. As previously announced, CHIASMA OPTIMAL met the primary endpoint and all secondary endpoints.

    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 B12 levels 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 or www.fda.gov/medwatch 

    The full Prescribing Information for MYCAPSSA is available at www.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 in the United States.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 open label extension of the CHIASMA OPTIMAL trial, and statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care, and the anticipated market acceptance of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, and the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, 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 Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

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  19. NEEDHAM, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock and, to certain investors in lieu thereof, pre-funded warrants to purchase up to 5,000,000 shares of its common stock at an exercise price of $0.0001 per share. The public offering price of each share of common stock is $4.00 and the public offering price of each pre-funded warrant…

    NEEDHAM, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock and, to certain investors in lieu thereof, pre-funded warrants to purchase up to 5,000,000 shares of its common stock at an exercise price of $0.0001 per share. The public offering price of each share of common stock is $4.00 and the public offering price of each pre-funded warrant is $3.9999 per underlying share. In addition, Chiasma has granted the underwriters a 30-day option to purchase up to an additional 2,625,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. This offering is expected to close on or about July 6, 2020, subject to satisfaction of customary closing conditions.

    Jefferies, Piper Sandler & Co. and Cantor are acting as book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager for the offering.

    Chiasma expects to receive gross proceeds of $70 million, before deducting underwriting discounts and offering expenses (without giving effect to any exercise of the underwriters' option to purchase additional shares, if any). Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly; activities to support the planned submission of a marketing authorization application to the European Medicines Agency for regulatory approval of MYCAPSSA in the European Union for acromegaly, assuming positive data from the MPOWERED Phase 3 trial; early clinical development of one or more potential pipeline candidates using its TPE platform technology; and working capital and other general corporate purposes.

    The securities are offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233654), including a base prospectus, filed by Chiasma on September 18, 2019 and declared effective by the Securities and Exchange Commission, or the SEC, on September 25, 2019. The offering will be made only by means of a prospectus. A preliminary prospectus supplement related to the offering has been filed with the SEC and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at ; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 Chiasma's public offering, future expectations, plans and prospects for Chiasma. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, 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. 

    Corporate Contact:

    Dawn Schottlandt

    Vice President, Investor Relations and Corporate Communications

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

    View Full Article Hide Full Article
  20. NEEDHAM, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced that it has commenced an underwritten public offering of its common stock, and, to certain investors in lieu thereof, pre-funded warrants to purchase shares of its common stock. In addition, Chiasma expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock plus the shares of common stock underlying the pre-funded warrants…

    NEEDHAM, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial biopharmaceutical company focused on developing and commercializing oral therapies utilizing its proprietary Transient Permeability Enhancer (TPE®) delivery platform technology to reduce the burden of chronic injections for people with rare diseases, today announced that it has commenced an underwritten public offering of its common stock, and, to certain investors in lieu thereof, pre-funded warrants to purchase shares of its common stock. In addition, Chiasma expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock plus the shares of common stock underlying the pre-funded warrants sold in connection with the offering. All of the securities to be sold in the offering are to be sold by Chiasma. This offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly; activities to support the planned submission of a marketing authorization application to the European Medicines Agency for regulatory approval of MYCAPSSA in the European Union for acromegaly, assuming positive data from the MPOWERED Phase 3 trial; early clinical development of one or more potential pipeline candidates using its TPE platform technology; and working capital and other general corporate purposes.

    Jefferies, Piper Sandler, and Cantor Fitzgerald. are acting as book-running managers for the offering.

    The securities are offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233654), including a base prospectus, filed by Chiasma on September 18, 2019 and declared effective by the Securities and Exchange Commission, or the SEC, on September 25, 2019. The offering will be made only by means of a prospectus. A preliminary prospectus supplement related to the offering and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 Chiasma's anticipated public offering, future expectations, plans and prospects for Chiasma. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, 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. 

    Corporate Contact:

    Dawn Schottlandt

    Vice President, Investor Relations and Corporate Communications

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

    Primary Logo

    View Full Article Hide Full Article
  21. MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide

    Conference call and webcast scheduled today at 2 pm ET

    NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved MYCAPSSA®(octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA and the first product approved by the FDA utilizing Chiasma's Transient Permeability…

    MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide

    Conference call and webcast scheduled today at 2 pm ET

    NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved MYCAPSSA®(octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA and the first product approved by the FDA utilizing Chiasma's Transient Permeability Enhancer (TPE®) technology. Acromegaly is a rare chronic disease often caused by a benign pituitary tumor and characterized by excess production of growth hormone and insulin-like growth factor-1 hormone that is frequently treated with chronic burdensome injections. If left untreated, acromegaly can lead to serious, and sometimes life-threatening medical conditions. The company estimates that approximately 8,000 patients are on injectable SSAs in the U.S. 

    "The FDA approval of MYCAPSSA represents a major therapeutic advancement for people with acromegaly and validation of our TPE delivery platform," said Raj Kannan, chief executive officer of Chiasma. "We are grateful to patients, healthcare providers, advocates and clinical trial investigators, as well as our employees who have worked diligently to bring MYCAPSSA to people with acromegaly. As we move into this next exciting phase as a commercial company, we are prepared to execute on a successful U.S. launch by working with healthcare providers to bring MYCAPSSA to as many patients who could benefit from it."

    "People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options," said Jill Sisco, president of the Acromegaly Community, Inc. "The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral SSA therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers."

    "For patients living with acromegaly and for their physicians and nurses, the FDA approval of oral octreotide capsules ushers in a new era of treatment," said Shlomo Melmed, MB, ChB, MACP, executive vice president of Academic Affairs and dean of the Medical Faculty at Cedars-Sinai. "Over the last 30 years treating physicians have come to trust octreotide in the treatment of acromegaly, and an oral alternative allows patients to avoid many of the documented treatment burdens associated with injections."

    "Results from the pivotal Phase 3 CHIASMA OPTIMAL clinical trial are encouraging for patients with acromegaly," said Susan Samson, M.D., Ph.D., FRCPC, FACE, principal investigator of the CHIASMA OPTIMAL clinical trial. "Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need."

    The company expects MYCAPSSA to be commercially available in the fourth quarter of 2020 subject to FDA's timely approval of a planned manufacturing supplement to the approved NDA. Chiasma plans to scale-up its customer facing team in sales, patient services and market access to approximately 45 employees. To help patients switch to MYCAPSSA, Chiasma plans to offer an array of patient support services ranging from assistance with insurance providers and specialty pharmacies to giving patients support to help incorporate MYCAPSSA seamlessly into their daily living. The company believes that patients, physicians, nurses, and payers will appreciate the significant benefits provided by MYCAPSSA. To ensure patients have broad access to this innovation, Chiasma plans to price MYCAPSSA competitively with the fastest growing SSA in the U.S. acromegaly market reflecting the value provided by MYCAPSSA to the health care system.

    The FDA approval of MYCAPSSA was based on the positive results of the randomized, double-blind, placebo-controlled, nine-month Phase 3 CHIASMA OPTIMAL clinical trial of octreotide capsules, which met the primary endpoint and all four secondary endpoints, as well as safety data from all of Chiasma's Phase 3 clinical trials of MYCAPSSA. The following important adverse reactions are described in the MYCAPSSA prescribing information: cholelithiasis and complications of cholelithiasis; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; and decreased vitamin B12 levels and abnormal Schilling's tests.

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the FDA approval of MYCAPSSA and provide a business update today, June 26, 2020, at 2:00 pm ET. The dial-in number in the U.S. / Canada is 1-877-407-4018; for international participants, the dial-in number is 1-201-689-8471. For all callers, please refer to Conference ID 13705297. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=140270

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    CHIASMA OPTIMAL Global Phase 3 Trial

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (octreotide or lanreotide) based upon levels of IGF-1, a byproduct of increased growth hormone (GH), levels caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening). Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring reversion to prior treatment. As previously announced, CHIASMA OPTIMAL met the primary endpoint and all secondary endpoints.

    About MYCAPSSA

    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. MYCAPSSA can cause a serious allergic reaction including anaphylactic shock. 

    IMPORTANT SAFETY INFORMATION

    Warnings 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 Schilling's tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment.

    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, oral hypoglycemic agents, beta‑blockers, 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.

    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 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA will be made available at www.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. The company estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is 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. On June 26, 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 is the first and only oral somatostatin analog approved by the FDA.  Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, statements regarding the commercial plans for and the commercialization of MYCAPSSA, including its pricing, reimbursement and market adoption, statements concerning the commercial or therapeutic potential of MYCAPSSA and the anticipated market acceptance of MYCAPSSA, statements regarding the company's plan to submit manufacturing supplements and the company's expectations regarding the availability of product supply, statements concerning the timing and success of a potential commercial launch of MYCAPSSA in the United States, and statements concerning the number of customer-facing employees and the timing of their hiring. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect any manufacturing supplements to the NDA the company plans to submit to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture API and commercial octreotide capsules, the company's ability to retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 crisis may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, 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.

    Corporate Contact:

    Dawn Schottlandt

    Vice President, Investor Relations and Corporate Communications

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

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  22. NEEDHAM, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today reported financial results for the first quarter of 2020 and provided a business update.

    "Chiasma continues to execute on our mission to develop and commercialize alternative options to injectable therapies," said Raj Kannan, Chief Executive Officer of Chiasma. "The COVID-19 global pandemic has changed the way we currently conduct business; however, we remain on track with our organizational readiness to execute a successful launch with MYCAPSSA in the fourth quarter…

    NEEDHAM, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today reported financial results for the first quarter of 2020 and provided a business update.

    "Chiasma continues to execute on our mission to develop and commercialize alternative options to injectable therapies," said Raj Kannan, Chief Executive Officer of Chiasma. "The COVID-19 global pandemic has changed the way we currently conduct business; however, we remain on track with our organizational readiness to execute a successful launch with MYCAPSSA in the fourth quarter of this year. If MYCAPSSA is approved, we believe that as the first oral somatostatin analog for acromegaly, it also has the potential to address a growing preference for non-medically administered products in the current environment."

    COVID-19 Business Impact – Projected 2020 Milestones Unchanged

    Chiasma is closely monitoring the impact of COVID-19 on its business and has implemented steps to ensure the well-being of its employees as well as patients and health care professionals involved in the MPOWERED study and the MACRO Registry. 

    • MYCAPSSA PDUFA Target Action Date: The U.S. Food and Drug Administration (FDA) has not notified Chiasma of any expected delays to its June 26, 2020 Prescription Drug User-Fee Act (PDUFA) target action date for our investigational oral octreotide capsules product candidate, conditionally trade-named MYCAPSSA.
       
    • MYCAPSSA Supply and Manufacturing: Chiasma has not observed any significant disruptions to the MYCAPSSA manufacturing supply chain. The company believes it will have sufficient commercial supply of MYCAPSSA to support its planned U.S. commercial launch in the fourth quarter of 2020, pending the FDA's timely approval of the NDA and a planned prior approval manufacturing supplement to the NDA.
       
    • MPOWERED Phase 3 Clinical Trial: Chiasma has been working with patients and health care professionals at MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared With injections – Evaluation of REsponse Durability) clinical trial sites to implement safety protocols for the remaining patients in the randomized controlled (RCT) phase of the trial. Of the 92 patients randomized into the nine-month RCT phase, 83 have completed the trial and six remain active in RCT. Additionally, the trial has met the European Medicines Agency (EMA) requirement of a minimum of 80 patients being randomized into the nine-month, randomized, controlled phase of the trial. The primary endpoint will be calculated with time weighted average (TWA) analysis, therefore missing monthly IGF-1 values are not anticipated to affect the completion of the primary endpoint analysis. The MPOWERED trial is designed to support an application for marketing approval of MYCAPSSA in the European Union. Chiasma remains on track to report top-line results in the fourth quarter of 2020.

    Recent Business Highlights and Anticipated 2020 Milestones

    • Anand Varadan Appointed Chief Commercial Officer (CCO): Mr.  Varadan was appointed Executive Vice President, Chief Commercial Officer in April 2020. Mr. Varadan leads Chiasma's commercial strategy and operations. He brings more than 20 years of relevant U.S. and international experience in leading both successful launches and in building commercial organizations.
       
    • Commenced Enrollment of the Management of Acromegaly (MACRO) Registry: Chiasma began enrollment, during the first quarter of 2020, in the MACRO registry which is targeting to enroll patients from over 40 clinical sites in the U.S. and collect real-world data on treatment burden and effectiveness of various acromegaly treatments.
       
    • Presentation and Publication of CHIASMA OPTIMAL Phase 3 Clinical Trial Results: Chiasma plans to present the positive results of the CHIASMA OPTIMAL trial through virtual platforms hosted by the Endocrine Society (ENDO) and American Association of Clinical Endocrinologists (AACE), in the second quarter of 2020. The company also plans to submit these positive results to a peer-reviewed journal for expected publication in mid-2020.
       
    • MYCAPSSA Planned U.S. Commercial Launch: Chiasma plans to launch MYCAPSSA in the United States in the fourth quarter of 2020, pending the FDA's timely approval of the NDA and a planned prior approval manufacturing supplement.
       
    • Top-line MPOWERED Phase 3 Clinical Trial Results: Chiasma expects to report top-line results from the MPOWERED Phase 3 open-label clinical trial of octreotide capsules in the fourth quarter of 2020.
       
    • HealthCare Royalty Partners (HCR) $75 Million Revenue Interest Financing Agreement: Chiasma entered into a revenue interest financing agreement with HCR, in April 2020, for up to $75 million to strengthen our current cash position, extend our cash runway if funding conditions are met, and to support our ongoing MYCAPSSA launch efforts.

    First Quarter 2020 Financial Results and Outlook

    • G&A Expenses: General and administrative expenses were $7.6 million for the first quarter ended March 31, 2020, compared with $2.5 million for the same period of 2019. The current period results include our continuing pre-commercial activities, an increase in compensation-related expenses, and increased other administrative costs as we prepare for the potential commercialization of octreotide capsules.
       
    • R&D Expenses: Research and development expenses were $8.1 million for the first quarter ended March 31, 2020, compared with $6.5 million for the same period of 2019. The increase was primarily driven by the manufacturing of octreotide capsules to support our commercial launch, if approved, 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 March 31, 2020, net loss was ($15.4) million, or ($0.36) per basic share, compared with a net loss of ($8.8) million, or ($0.36) per basic share, for the same period of 2019.
       
    • Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2020, were $79.3 million, compared with $92.4 million as of December 31, 2019. In April 2020, the company received the initial $25.0 million payment, less certain transaction expenses, from HCR under the previously announced revenue interest financing agreement. Under this agreement, Chiasma is entitled to an additional $25.0 million upon FDA approval of MYCAPSSA, $15.0 million upon the availability of commercial drug supply and first commercial sale of MYCAPSSA and $10 million in early 2022 subject to the achievement of a commercial milestone. 

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the first quarter results in more detail today, May 7, 2020, at 5:00 pm ET. The dial-in number in the U.S. / Canada is 1-800-949-2175; for international participants, the dial-in number is 1-856-344-9283. For all callers, please refer to Conference ID 3434236. To access the live webcast, please use the following link: https://edge.media-server.com/mmc/p/whqk8h8r

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    CHIASMA OPTIMAL Global Phase 3 Trial

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs based upon levels of IGF-1, a byproduct of increased growth hormone, or GH, levels caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening). Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment effect include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring rescue treatment. As previously announced, CHIASMA OPTIMAL met the primary endpoint and all secondary endpoints.

    MPOWERED™ Phase 3 Trial

    Chiasma is also conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the company's oral octreotide capsules for the maintenance treatment of adult patients with acromegaly. The trial, referred to as MPOWERED, is a randomized, open-label and active-controlled, 15-month trial intended to support regulatory approval in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019. In January 2020, the randomization of patients was completed. Of the 146 patients that entered the six-month run-in phase of the trial, 92 of these patients (or 63%) completed the run-in phase and were deemed to be responders to octreotide capsules per protocol (IGF-1 <1.3 x ULN and GH<2.5 ng/mL). Responders to octreotide capsules were randomized (2:3) per protocol to either go back to their original long-acting injectable somatostatin analog or remain on octreotide capsules at the dose identified during the run-in phase and then followed for an additional nine months.   The trial has met the EMA's requirement of a minimum of 80 patients being randomized into the nine-month, randomized, controlled phase of the trial. 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 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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory filings and reviews and potential approvals, statements concerning the nature of the FDA's review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, statements regarding the company's plan to submit prior approval manufacturing supplements following a potential NDA approval and the company's expectations regarding the availability of product supply, statements concerning the timing and success of a potential commercial launch of MYCAPSSA in the United States, and statements regarding the release of top-line results from the MPOWERED Phase 3 trial. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations.  Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the NDA and any prior approval manufacturing supplements to the NDA the company may submit to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture API and commercial octreotide capsules, the company's ability to obtain and retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 crisis may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, 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.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

    Media Relations:
    Patrick Bursey
    LifeSci Communications
    646-876-4932

     
    Chiasma, Inc.
    Condensed Consolidated Statements of Operations
    (amounts in thousands except share and per share data)
    (unaudited)
           
      For the three months ended
      March 31, 2020   March 31, 2019
    Operating expenses:      
    General and administrative $ 7,582     $ 2,450  
    Research and development   8,125       6,471  
    Total operating expenses   15,707       8,921  
    Loss from operations   (15,707 )     (8,921 )
    Other income, net   (398 )     (184 )
    Loss before income taxes   (15,309 )     (8,737 )
    Provision for income taxes   77       13  
    Net loss $ (15,386 )   $ (8,750 )
           
    Earnings per share of common stock:      
    Basic $ (0.36 )   $ (0.36 )
    Diluted $ (0.36 )   $ (0.36 )
           
    Weighted-average shares outstanding:      
    Basic   42,187,694       24,466,617  
    Diluted   42,187,694       24,466,617  
           


     
    Chiasma, Inc.
    Condensed Consolidated Balance Sheets Information
    (amounts in thousands)
    (unaudited)
           
      March 31, 2020   December 31, 2019
           
    Cash and cash equivalents $ 42,555   $ 27,855
    Marketable securities   36,707     64,520
    Prepaid expenses and other current assets   4,877     3,881
    Property and equipment, net   590     334
    Other assets   1,993     2,236
    Total assets $ 86,722   $ 98,826
           
    Accounts payable $ 5,450   $ 3,253
    Accrued expenses   7,238     7,576
    Other current liabilities   716     546
    Long-term liabilities   1,575     1,682
    Total liabilities   14,979     13,057
    Total stockholders' equity   71,743     85,769
    Total liabilities and stockholders' equity $ 86,722   $ 98,826
           

     

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  23. NEEDHAM, Mass., April 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it will host a conference call and live audio webcast on Thursday, May 7, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter ended March 31, 2020 and to provide a business update.

    Conference Call Details

    Thursday, May 7th @ 5pm Eastern Time

    Domestic:800-949-2175
    International: 856-344-9283
    Conference ID: 3434236
    Webcast:https://edge.media-server.com/mmc/p/whqk8h8r
      

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of…

    NEEDHAM, Mass., April 30, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it will host a conference call and live audio webcast on Thursday, May 7, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter ended March 31, 2020 and to provide a business update.

    Conference Call Details

    Thursday, May 7th @ 5pm Eastern Time

    Domestic:800-949-2175
    International: 856-344-9283
    Conference ID: 3434236
    Webcast:https://edge.media-server.com/mmc/p/whqk8h8r
      

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Dawn Schottlandt

    Chiasma

    617-928-5208

     

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

     

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  24. NEEDHAM, Mass., April 22, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today announced the appointment of Anand Varadan as Executive Vice President, Chief Commercial Officer. Mr. Varadan will lead Chiasma's commercial strategy and operations.

    "We are fortunate to have someone of Anand's caliber join our leadership team. Anand's prior tenure with Chiasma and his breadth and depth of relevant experience building commercial organizations and leading successful product launches will be critical to our success," said Raj Kannan, Chief Executive Officer…

    NEEDHAM, Mass., April 22, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today announced the appointment of Anand Varadan as Executive Vice President, Chief Commercial Officer. Mr. Varadan will lead Chiasma's commercial strategy and operations.

    "We are fortunate to have someone of Anand's caliber join our leadership team. Anand's prior tenure with Chiasma and his breadth and depth of relevant experience building commercial organizations and leading successful product launches will be critical to our success," said Raj Kannan, Chief Executive Officer of Chiasma. "Anand's strategic orientation and leadership skills will be instrumental to our growth plans as he oversees our commercial strategy to ensure that patients have access to our potential new treatment option, MYCAPSSA for adult patients with acromegaly, if approved."

    Mr. Varadan served as Chiasma's Chief Commercial Officer until June 2016. He reengaged with the company as a strategic advisor in early 2018 and has been leading MYCAPSSA launch preparations over the last eight months. Previously, Mr. Varadan served as Executive Vice President, Chief Commercial Officer of Karyopharm Therapeutics, Inc., an oncology-focused pharmaceutical company, until July 2019 where he built their commercial organization and led preparations for the successful launch of Xpovio for multiple myeloma. Earlier in his career, Mr. Varadan held several commercial and general management leadership positions at Amgen Inc. in the U.S., E.U. and Canada, including Vice President of the $8 billion U.S. Inflammation and Nephrology Business Unit and Vice President and General Manager of all Amgen operations in Canada. He is also the Founder and President of Ignition Insights LLC, a strategic consulting firm. Mr. Varadan holds a master's degree in business administration from the Simon Business School at the University of Rochester and a bachelor's degree in Zoology from The George Washington University.

    Mr. Varadan added, "I am honored to rejoin Chiasma as Chief Commercial Officer and look forward to working closely with the leadership team to successfully launch MYCAPSSA, if approved, and build the company by leveraging its exciting technology platform. I have been inspired by the Company's mission to develop and commercialize alternative options to injectable therapies to provide patients with greater independence. I am pleased to join an exceptional team and help to potentially provide MYCAPSSA, if approved, to the patients that could benefit from it."

    Inducement Grant under NASDAQ Listing Rule 5635(c)(4)

    In connection with the hiring of Mr. Varadan, the Compensation Committee of Chiasma's Board of Directors granted a stock option to purchase 425,000 shares of Chiasma's common stock to Mr. Varadan. The option was granted as an inducement material to Mr. Varadan's acceptance of employment with Chiasma in accordance with NASDAQ Listing Rule 5635(c)(4). The option has an exercise price of $4.43 per share, which is equal to the closing price of Chiasma's common stock on the grant date, April 22, 2020. The option vests over four years, with 25% of the shares underlying the option vesting on the first anniversary of the grant date and the remaining 75% of the shares underlying the stock option vesting in equal monthly installments for the following 36 months, subject to Mr. Varadan's continued service to Chiasma through the applicable vesting dates. The option has a 10-year term and is subject to the terms and conditions of a stock option agreement between Chiasma and Mr. Varadan.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory review and potential approval, statements concerning the timing of the FDA's review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, and statements concerning the potential commercial launch of MYCAPSSA in the United States. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the NDA, the company's ability to obtain and retain requisite regulatory approvals and commercial product supply for the commercial launch of octreotide capsules in the United States, the timing and costs involved in establishing a commercial organization, and the impact the ongoing COVID-19 crisis may have on Chiasma's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2019 and in subsequent SEC filings. 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:
    Dawn Schottlandt
    Chiasma
    617-928-5208

    Media Relations:
    Patrick Bursey
    LifeSci Communications
    646-876-4932

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  25. NEEDHAM, Mass., April 08, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced its entry into a revenue interest financing agreement with HealthCare Royalty Partners (HCR) for up to $75 million to support the ongoing development and planned commercial launch of its investigational octreotide capsules product candidate, trade-named MYCAPSSA®, for the maintenance treatment of adults with acromegaly.

    Under the terms of the agreement, Chiasma will receive $25 million from HCR on April 14, 2020 and is entitled to receive an additional $25 million upon the U.S. Food and Drug Administration (FDA…

    NEEDHAM, Mass., April 08, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical, late-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced its entry into a revenue interest financing agreement with HealthCare Royalty Partners (HCR) for up to $75 million to support the ongoing development and planned commercial launch of its investigational octreotide capsules product candidate, trade-named MYCAPSSA®, for the maintenance treatment of adults with acromegaly.

    Under the terms of the agreement, Chiasma will receive $25 million from HCR on April 14, 2020 and is entitled to receive an additional $25 million upon the U.S. Food and Drug Administration (FDA) approval of MYCAPSSA and an additional $15 million upon the availability of commercial drug supply and first commercial sale of MYCAPSSA. Chiasma is also entitled to receive an additional $10 million in early 2022 subject to the achievement of a commercial milestone. In exchange for the total investment amount received, HCR will receive a tiered royalty in the low double digits on worldwide annual net revenues of MYCAPSSA and any other future products, subject to step-downs upon the achievement of certain annual revenues.

    "Healthcare Royalty Partners is a top-tier investment firm that provides important validation for Chiasma as we near our PDUFA date and move towards our goal of bringing the first oral somatostatin analog to acromegaly patients," said Raj Kannan, Chief Executive Officer of Chiasma.  "We appreciate the extensive due diligence conducted by Healthcare Royalty Partners and plan to use the proceeds from this non-dilutive financing to support our ongoing activities as we prepare for a robust U.S. commercial launch of MYCAPSSA, if approved."

    "We are pleased to partner with Chiasma and its management team, which brings impressive commercial expertise and a commitment to addressing unmet medical needs," said Clarke Futch, Managing Partner and Chairman of the Investment Committee of Healthcare Royalty Partners. "Our extensive due diligence gives us confidence that the commercial prospects for MYCAPSSA in acromegaly are compelling and offer an attractive investment opportunity for HCR."

    Chiasma announced on January 13, 2020 that the FDA accepted for review the New Drug Application (NDA) resubmission for MYCAPSSA for the maintenance treatment of adults with acromegaly. The FDA assigned a Prescription Drug User-Fee Act (PDUFA) target action date of June 26, 2020, which is a six-month review.

    Goodwin Procter LLP acted as counsel to Chiasma on the transaction.

    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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About HealthCare Royalty Partners

    HealthCare Royalty Partners ("HCR") is a private investment firm that purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage biopharmaceutical assets. HCR has $5.5 billion in cumulative capital commitments with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.healthcareroyalty.com.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's expectations relating to the anticipated proceeds and use of proceeds from, and the financial and other benefits of, the revenue interest financing agreement with HCR, the company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory review and potential approval, statements concerning the nature of the FDA's review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, and statements concerning the potential commercial launch of MYCAPSSA in the United States. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the NDA, the ability of the company and HCR to perform their respective obligations under the revenue interest financing agreement, the company's ability to obtain and retain requisite regulatory approvals and commercial product supply for the commercial launch of octreotide capsules in the United States, the timing and costs involved in establishing a commercial organization, and the impact the ongoing COVID-19 crisis may have on Chiasma's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2019. 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:

    Dawn Schottlandt

    Chiasma

    617-928-5208

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

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  26. MYCAPSSA® PDUFA Date Set for June 26, 2020; U.S. Commercial Launch Planned in Q4'20

    First Industry Sponsored U.S. Disease State Registry for Acromegaly Began Enrolling Patients

    NEEDHAM, Mass., March 16, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

    "Our focus for 2020 is on obtaining U.S. regulatory approval for MYCAPSSA® as a maintenance treatment for adult patients with acromegaly and subsequently executing a successful launch…

    MYCAPSSA® PDUFA Date Set for June 26, 2020; U.S. Commercial Launch Planned in Q4'20

    First Industry Sponsored U.S. Disease State Registry for Acromegaly Began Enrolling Patients

    NEEDHAM, Mass., March 16, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical stage biopharmaceutical company focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided a business update.

    "Our focus for 2020 is on obtaining U.S. regulatory approval for MYCAPSSA® as a maintenance treatment for adult patients with acromegaly and subsequently executing a successful launch," said Raj Kannan, Chief Executive Officer of Chiasma. "With our NDA resubmission accepted for review by the FDA, we are preparing for a commercial launch to establish the foundation needed for long-term growth."

    Recent Business Highlights and Anticipated 2020 Milestones

    • MYCAPSSA NDA Acceptance: Chiasma announced on January 13, 2020 that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for its oral octreotide capsules investigational product candidate, conditionally trade named MYCAPSSA, for the treatment of adults with acromegaly. The FDA assigned a Prescription Drug User-Fee Act (PDUFA) target action date of June 26, 2020, which is a six-month review.
       
    • The Management of Acromegaly (MACRO) Registry: Chiasma began enrolling patients in the first-ever industry sponsored U.S. disease state registry for acromegaly. The MACRO registry is designed to enroll patients from over 40 clinical sites in the U.S. and collect real-world data on treatment burden and effectiveness of various acromegaly treatments.
       
    • Publication of CHIASMA OPTIMAL Phase 3 Clinical Trial Results: Chiasma plans to submit the positive results of the CHIASMA OPTIMAL trial to a peer-reviewed journal for expected publication in mid-2020.
       
    • MYCAPSSA Planned U.S. Commercial Launch: Chiasma plans to launch MYCAPSSA in the United States in the fourth quarter of 2020, pending the FDA's timely approval of the NDA and either of the planned prior approval manufacturing supplements to the NDA.
       
    • Top-line MPOWERED Phase 3 Clinical Trial Results: Chiasma expects to report top-line results from the MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared With injections – Evaluation of REsponse Durability) Phase 3 open-label clinical trial of octreotide capsules in the fourth quarter of 2020.
       
    • Pipeline Expansion Leveraging Transient Permeability Enhancer (TPE®) Technology: Chiasma plans to announce its pipeline expansion plans to develop one or more oral therapies targeting diseases with unmet needs following the anticipated approval of MYCAPSSA for the maintenance treatment of adults with acromegaly.

    Fourth Quarter and Year Full Year 2019 Financial Results and Outlook

    • G&A Expenses: General and administrative expenses were $5.9 million for the fourth quarter ended December 31, 2019, compared with $2.7 million for the same period of 2018. The current period results include increased pre-commercial activity and compensation related expenses which were primarily offset by a reduction in legal expenses. General and administrative expenses were $15.1 million for the year ended December 31, 2019, compared with $10.0 million for the year ended December 31, 2018. The increase was primarily driven by the initiation of pre-commercial activities and compensation related expenses which were primarily offset by a reduction in legal expenses.
       
    • R&D Expenses: Research and development expenses were $6.4 million for the fourth quarter ended December 31, 2019, compared with $5.7 million for the same period of 2018. The increase was primarily driven by increased regulatory and manufacturing costs and offset by decreased clinical trials costs. Research and development expenses were $22.5 million for the year ended December 31, 2019, compared with $22.4 million for the year ended December 31, 2018. Though the change was immaterial, we observed an increase in regulatory and manufacturing costs offset by a decrease in clinical trials costs.
       
    • Net Loss: For the quarter ended December 31, 2019, net loss was ($12.0) million, or ($0.29) per basic share, compared with ($8.1) million, or ($0.32) per basic share, for the same period of 2018. For the year ended December 31, 2019, net loss was ($36.3) million, or ($1.06) per basic share, compared with ($31.3) million, or ($1.28) per basic share, for the same period of 2018.
       
    • Cash Position and Outlook: Cash, cash equivalents and marketable securities as of December 31, 2019, were $92.4 million, compared with $41.7 million as of December 31, 2018. The Company expects that its current cash, cash equivalents and marketable securities balance is sufficient to fund its operations as currently planned through at least 2020.

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the fourth quarter results in more detail today, March 16, 2020, at 5:00 pm ET. The dial-in number in the U.S. / Canada is 1-877-407-4018; for international participants, the dial-in number is 1-201-689-8471.  For all callers, please refer to Conference ID 13699225. To access the live webcast, please use the following link: https://edge.media-server.com/mmc/p/b4e8rvsn

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, http://ir.chiasmapharma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    CHIASMA OPTIMAL Global Phase 3 Trial

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs based upon levels of IGF-1, a byproduct of increased growth hormone, or GH, levels caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day (equaling one capsule in the morning and one capsule in the evening) to up to a maximum of 80 mg per day (equaling two capsules in the morning and two capsules in the evening). Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment effect include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring rescue treatment.

    MPOWERED™ Phase 3 Trial

    Chiasma is also conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the company's oral octreotide capsules for the maintenance treatment of adult patients with acromegaly. The trial, referred to as MPOWERED, is a randomized, open-label and active-controlled, 15-month trial intended to support regulatory approval in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019. In January 2020, the randomization of patients was completed. Of the 146 patients that entered the six-month run-in phase of the trial, 92 of these patients (or 63%) completed the run-in phase and were deemed to be responders to octreotide capsules per protocol (IGF-1 <1.3 x ULN and GH<2.5 ng/mL). Responders to octreotide capsules were randomized (2:3) per protocol to either go back to their original long-acting injectable somatostatin analog or remain on octreotide capsules at the dose identified during the run-in phase 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 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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory filings and reviews and potential approvals, statements concerning the nature of the FDA's review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, statements regarding the company's plan to submit two manufacturing supplements for an additional API manufacturer and an additional API manufacturing site following a potential NDA approval and the company's expectations regarding the availability of product supply, statements concerning the timing of potential commercial launch of MYCAPSSA in the United States, statements regarding the release of top-line results from the MPOWERED Phase 3 trial, statements regarding the company's cash forecasts and need for capital, including that it has sufficient existing cash and investments on hand to fund its operations through at least 2020, and announcements of pipeline expansion plans. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations.  Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the NDA and any manufacturing supplements to the NDA the company may submit to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture API and commercial octreotide capsules, the company's ability to obtain and retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization. Furthermore, the company will require additional capital to fund its planned operations beyond 2020, which may not be available to it on attractive terms or at all.   If the company is unable to secure additional capital, it may be forced to delay, limit, reduce or terminate its development and planned commercialization of MYCAPSSA.  For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2019. 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.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

    Media Relations:
    Patrick Bursey
    LifeSci Communications
    646-876-4932

    Chiasma, Inc.  
    Condensed Consolidated Statements of Operations  
    (amounts in thousands except share and per share data)  
    (unaudited)  
                     
      For the three months ended   For the twelve months ended  
      December 31, 2019   December 31, 2018   December 31, 2019   December 31, 2018  
    Operating expenses:                
    General and administrative $ 5,912     $ 2,657     $ 15,122     $ 9,974    
    Research and development   6,354       5,732       22,457       22,362    
    Total operating expenses   12,266       8,389       37,579       32,336    
    Loss from operations   (12,266 )     (8,389 )     (37,579 )     (32,336 )  
    Other income, net   (469 )     (259 )     (1,543 )     (1,044 )  
    Loss before income taxes   (11,797 )     (8,130 )     (36,036 )     (31,292 )  
    Benefit from Income Taxes   250       (55 )     284       (31 )  
    Net loss $ (12,047 )   $ (8,075 )   $ (36,320 )   $ (31,261 )  
                     
    Earnings per share of common stock:                
    Basic $ (0.29 )   $ (0.32 )   $ (1.06 )   $ (1.28 )  
    Diluted $ (0.29 )   $ (0.32 )   $ (1.06 )   $ (1.28 )  
                     
    Weighted-average shares outstanding:                
    Basic   42,022,030       24,442,370       34,204,284       24,399,706    
    Diluted   42,022,030       24,442,370       34,204,284       24,399,706    
                     


    Chiasma, Inc.  
    Condensed Consolidated Balance Sheets Information  
    (amounts in thousands)  
    (unaudited)  
             
      December 31, 2019   December 31, 2018  
             
    Cash and cash equivalents $ 27,855   $ 13,060  
    Marketable securities   64,520     28,602  
    Insurance recovery   -     18,288  
    Prepaid expenses and other current assets   3,881     2,237  
    Property and equipment, net   334     111  
    Other assets   2,236     958  
    Total assets $ 98,826   $ 63,256  
             
    Accounts payable $ 3,253   $ 2,029  
    Estimated settlement liability   -     18,750  
    Accrued expenses   7,576     7,848  
    Other current liabilities   546     -  
    Long-term liabilities   1,682     505  
    Total liabilities   13,057     29,132  
    Total stockholders' equity   85,769     34,124  
    Total liabilities and stockholders' equity $ 98,826   $ 63,256  
             

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  27. NEEDHAM, Mass., March 09, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it will host a conference call and live audio webcast on Monday, March 16, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter and year ended December 31, 2019 and to provide a business update.

    Conference Call Details

    Monday, March 16th @ 5pm Eastern Time

    Domestic: 1-877-407-4018
    International:  1-201-689-8471
    Conference ID:  13699225
    Webcast: https://edge.media-server.com/mmc/p/b4e8rvsn
       

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section…

    NEEDHAM, Mass., March 09, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it will host a conference call and live audio webcast on Monday, March 16, 2020 at 5:00 p.m. Eastern Time to discuss financial results for the quarter and year ended December 31, 2019 and to provide a business update.

    Conference Call Details

    Monday, March 16th @ 5pm Eastern Time

    Domestic: 1-877-407-4018
    International:  1-201-689-8471
    Conference ID:  13699225
    Webcast: https://edge.media-server.com/mmc/p/b4e8rvsn
       

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, http://ir.chiasmapharma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

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  28. FDA sets PDUFA date of June 26, 2020

    Acceptance follows December 26, 2019 NDA resubmission

    NEEDHAM, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for its oral octreotide capsules investigational product candidate, conditionally trade named MYCAPSSA®. Chiasma is developing MYCAPSSA for the maintenance treatment of adults with acromegaly. The FDA assigned a Prescription Drug User-Fee Act (PDUFA) target action date of June 26, 2020, which is a six-month review.

    "The FDA…

    FDA sets PDUFA date of June 26, 2020

    Acceptance follows December 26, 2019 NDA resubmission

    NEEDHAM, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for its oral octreotide capsules investigational product candidate, conditionally trade named MYCAPSSA®. Chiasma is developing MYCAPSSA for the maintenance treatment of adults with acromegaly. The FDA assigned a Prescription Drug User-Fee Act (PDUFA) target action date of June 26, 2020, which is a six-month review.

    "The FDA acceptance of our NDA resubmission marks the achievement of the first planned 2020 milestone for Chiasma and is a significant step towards making MYCAPSSA available to eligible patients," said Raj Kannan, Chief Executive Officer of Chiasma. "If approved, we believe MYCAPSSA, as the first oral somatostatin analog, has the potential to change the standard of pharmacological care in the management of patients with acromegaly. We look forward to working with the FDA during the review process towards a potential approval."

    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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In January 2020, the FDA accepted the company's NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.  Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory review and potential approval, statements concerning the nature of the FDA's review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, including the potential to change the standard of pharmacological care in the management of patients with acromegaly, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations.  For example, there can be no guarantee that the FDA will agree that MYCAPSSA qualifies for marketing approval in the United States based on the results from the CHIASMA OPTIMAL trial and other information contained in the NDA.  Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2018, 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.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

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  29. MYCAPSSA®NDA resubmitted to FDA; PDUFA decision expected mid-2020

    MYCAPSSA® U.S. commercial launch planned for the fourth quarter of 2020

    Top-line MYCAPSSA® MPOWERED Phase 3 results on track for the fourth quarter of 2020

    NEEDHAM, Mass., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today reviewed its 2019 highlights and previewed its anticipated 2020 corporate milestones.

    2019 Key Highlights:

    • MYCAPSSA New Drug Application (NDA) Resubmitted to FDA: On December 26, Chiasma resubmitted its NDA to the U.S. Food and Drug Administration (FDA) for its investigational octreotide capsules product candidate…

    MYCAPSSA® NDA resubmitted to FDA; PDUFA decision expected mid-2020

    MYCAPSSA® U.S. commercial launch planned for the fourth quarter of 2020

    Top-line MYCAPSSA® MPOWERED Phase 3 results on track for the fourth quarter of 2020

    NEEDHAM, Mass., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today reviewed its 2019 highlights and previewed its anticipated 2020 corporate milestones.

    2019 Key Highlights:

    • MYCAPSSA New Drug Application (NDA) Resubmitted to FDA: On December 26, Chiasma resubmitted its NDA to the U.S. Food and Drug Administration (FDA) for its investigational octreotide capsules product candidate, MYCAPSSA, for the maintenance treatment of adults with acromegaly. The positive results from the CHIASMA OPTIMAL trial, which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA, support the NDA resubmission. Chiasma expects a six-month review of the NDA resubmission. The NDA resubmission marks an important milestone in the company's effort to bring an oral somatostatin analog to patients.
       
    • Manufacturing Plans: Following anticipated NDA approval, and in order to have commercial supply of MYCAPSSA product for launch, Chiasma expects to submit two manufacturing supplements to provide for (i) an additional active pharmaceutical ingredient (API) manufacturer and (ii) an additional commercial-scale manufacturing site affiliated with the API manufacturer currently referenced in the NDA. Chiasma is currently procuring API from both sources in anticipation of NDA approval. Chiasma expects to have adequate product available to support its planned commercial launch in the fourth quarter of 2020, subject to FDA's timely approval of the NDA and either of the manufacturing supplements.
       
    • CHIASMA OPTIMAL Global Phase 3 Trial for Acromegaly Met the Primary and All Secondary Endpoints: In July, Chiasma announced that the primary endpoint of the CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment IMultinationAL centers) trial, the proportion of patients biochemically (IGF-1 ≤ 1.0 x ULN) controlled at the end of the trial, was achieved. Additionally, all four secondary endpoints were met. The CHIASMA OPTIMAL trial was conducted under an SPA agreement with the FDA and evaluated MYCAPSSA for the maintenance treatment of adults with acromegaly.
       
    • Three Posters Presented at ENDO 2019 Highlighted Significant Unmet Needs in U.S. Acromegaly Patients: Data presented concluded that patients currently treated on injectable somatostatin analog therapies experience a significant disease burden and treatment dissatisfaction even when biochemically-controlled using existing therapies.
       
    • MPOWERED Phase 3 Trial Completed Enrollment and Randomization: The MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared With injections – Evaluation of REsponse Durability) trial, designed to support approval of MYCAPSSA in the European Union for acromegaly, completed enrollment in June 2019. As of January 2020, the randomization was completed. Responders to the octreotide capsules were randomized per the protocol (IGF-1 < 1.3 x ULN) into the nine-month randomized controlled phase.
       
    • Chiasma appointed key leaders in medical affairs, market access, patient services and marketing: Chiasma began its transformation into a commercial-ready organization with the appointment of a commercially-experienced chief executive officer and the addition of experienced leaders in marketing, market access and patient services. Chiasma has also expanded its medical affairs function, including hiring a leader with strategic medical and scientific expertise.

    "2019 was a successful year for Chiasma, highlighted by the positive results from the Phase 3 CHIASMA OPTIMAL trial and the NDA resubmission," said Raj Kannan, Chief Executive Officer of Chiasma. "Looking ahead, 2020 has the potential to be a transformational year for our company as we focus on executing a successful launch of the first oral somatostatin analog for the treatment of acromegaly."

    Anticipated 2020 Milestones and Other Guidance:

    • MYCAPSSA NDA Acceptance: Chiasma anticipates that within 30 days of its NDA resubmission the FDA will determine whether the NDA is complete and ready for review and provide the review timeline.
       
    • ENDO 2020 Conference: Chiasma has been selected to present the CHIASMA OPTIMAL Global Phase 3 results in an oral presentation at the Endo 2020 conference. Additional abstracts have been submitted to the conference which is being held March 28-31, 2020 in San Francisco, CA.
       
    • Publication of CHIASMA OPTIMAL Phase 3 Results: Chiasma plans to submit the final results of the CHIASMA OPTIMAL trial to a peer-reviewed journal for expected publication in mid-2020.
       
    • MYCAPSSA PDUFA Decision: Chiasma expects a six-month review of the MYCAPSSA NDA resubmission and a PDUFA decision from the FDA in mid-2020.
       
    • MYCAPSSA U.S. Commercial Launch: Chiasma plans to launch MYCAPSSA in the United States in the fourth quarter of 2020, pending FDA's timely approval of the NDA and either of the planned manufacturing supplements to the NDA.
       
    • Top-line MPOWERED Phase 3 Results: Chiasma expects to report top-line results from the MPOWERED Phase 3 open-label trial of MYCAPSSA in the fourth quarter of 2020.
       
    • Pipeline Expansion Leveraging Transient Permeability Enhancer (TPE®) Technology: Chiasma plans to announce its indication and pipeline expansion plans to develop one or more oral therapies targeting rare and serious chronic diseases with unmet needs following the anticipated approval of MYCAPSSA for the maintenance treatment of adults with acromegaly.
       
    • Cash: As of December 31, 2019, Chiasma had approximately $92 million in cash, cash equivalents and marketable securities, which is expected to fund its operations, as currently planned, through at least 2020, including key milestones such as the planned FDA approval of MYCAPSSA, the anticipated U.S. commercial launch, and the release of top-line MPOWERED Phase 3 results.

    Chiasma management will be available to meet with institutional investors and analysts at the 2020 LifeSci Advisors Corporate Access Event, which is being held from January 13-15, 2020, in San Francisco, CA.

    CHIASMA OPTIMAL Trial Design

    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling two capsules in the morning and two capsules in the evening. Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures and reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring rescue treatment.

    MPOWERED™ Phase 3 Trial

    Chiasma is also conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the company's 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 92 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 are being 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 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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. In December 2019, Chiasma resubmitted to the FDA its NDA seeking marketing approval for MYCAPSSA in the United States. Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.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 company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, the data from the CHIASMA OPTIMAL trial and whether the data and the rest of the regulatory submission will support the acceptance by the FDA of the company's NDA resubmission for octreotide capsules as complete and ready for review and ultimately regulatory approval, statements regarding the timing of regulatory review, including the acceptance of the NDA and the company's anticipated eligibility for a six-month PDUFA review cycle, and potential approval, statements concerning the nature of the FDA's review of any such NDA resubmission and whether the data submission will be sufficient to support regulatory approval, statements regarding the company's plan to submit manufacturing supplements for an additional API manufacturer and API manufacturing site following a potential NDA approval and the company's expectations regarding the availability of product supply, statements concerning the timing of potential commercial launch of MYCAPSSA in the United States, statements regarding the release of top-line date from the MPOWERED Phase 3 trial, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, statements regarding the company's cash forecasts, including its expected cash and investment balances as of the end of 2019 and that it has sufficient existing cash and investments on hand to fund its operations through key milestones such as the planned FDA approval of MYCAPSSA, the anticipated U.S. commercial launch and the release of top-line MPOWERED Phase 3 data and that its cash and investments balance is sufficient to fund operations as currently planned through at least 2020, and statements concerning future announcements of indication and pipeline expansion plans. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations.  For example, there can be no guarantee that the FDA will agree that the NDA resubmission is a complete response to the FDA's April 2016 complete response letter or that MYCAPSSA qualifies for marketing approval in the United States based on the results from the CHIASMA OPTIMAL trial and other information contained in the NDA.  Further, there can be no guarantee that, even if the NDA is approved, the company will submit manufacturing supplements to the NDA for an additional API manufacturer and additional API manufacturing site to provide commercial API supply or that the FDA will accept the filing of either supplement or approve such additional API manufacturer or additional API manufacturing site, in each case, in a timely manner or at all.  Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, including with respect to the NDA and any manufacturing supplements to the NDA we may submit to the FDA, the results of any inspections of the company's third-party manufacturers, the company's reliance on third parties to manufacture API and commercial octreotide capsules, the company's ability to obtain and retain requisite regulatory approvals for the commercial launch of octreotide capsules in the United States, and the timing and costs involved in establishing a commercial organization. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2018, 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.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

     

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  30. NEEDHAM, Mass., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI) effective prior to market open on Monday, December 23, 2019.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology and ranked on an annual basis…

    NEEDHAM, Mass., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI) effective prior to market open on Monday, December 23, 2019.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology and ranked on an annual basis. All securities in the NASDAQ Biotechnology Index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements among other criteria. The NASDAQ Biotechnology Index is also the basis for the iShares NASDAQ Biotechnology Index (SM) Fund. For more information about the NASDAQ Biotechnology Index visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Needham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

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  31. WALTHAM, Mass., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that Raj Kannan, Chief Executive Officer, and William Ludlam, M.D., Ph.D., Senior Vice President of Clinical Development and Medical Affairs, will participate in an analyst-led fireside chat at the Piper Jaffray 31st Annual Healthcare Conference, which is being held December 3rd to 5th  in New York, New York.  Management is scheduled to present on Tuesday, December 3rd at 8:30 a.m. ET.

    A live audio webcast of the fireside chat will be available on the News and Investors section of Chiasma's website at www.chiasma.com. A replay…

    WALTHAM, Mass., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that Raj Kannan, Chief Executive Officer, and William Ludlam, M.D., Ph.D., Senior Vice President of Clinical Development and Medical Affairs, will participate in an analyst-led fireside chat at the Piper Jaffray 31st Annual Healthcare Conference, which is being held December 3rd to 5th  in New York, New York.  Management is scheduled to present on Tuesday, December 3rd at 8:30 a.m. ET.

    A live audio webcast of the fireside chat will be available on the News and Investors section of Chiasma's website at www.chiasma.com. A replay of the webcast will be available shortly after the conclusion of the presentation.  

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the Company reported positive top-line data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.chiasma.com.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

    Investor Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-775-5956

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  32. WALTHAM, Mass., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that William Ludlam, M.D., Ph.D., Senior Vice President of Clinical Development and Medical Affairs, will present at the 13th Acromegaly Consensus Conference, to be held from November 17th-19th in Fort Lauderdale, Florida. Dr. Ludlam is scheduled to present on Sunday, November 17th.

    "We are pleased to be sharing positive top-line data from our Phase 3 CHIASMA OPTIMAL trial of MYCAPSSA®, that is being developed for the maintenance treatment of adult acromegaly patients, at the conference this year," said Dr. William Ludlam…

    WALTHAM, Mass., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that William Ludlam, M.D., Ph.D., Senior Vice President of Clinical Development and Medical Affairs, will present at the 13th Acromegaly Consensus Conference, to be held from November 17th-19th in Fort Lauderdale, Florida. Dr. Ludlam is scheduled to present on Sunday, November 17th.

    "We are pleased to be sharing positive top-line data from our Phase 3 CHIASMA OPTIMAL trial of MYCAPSSA®, that is being developed for the maintenance treatment of adult acromegaly patients, at the conference this year," said Dr. William Ludlam. "We believe there is a high unmet need amongst acromegaly patients for treatment options that can address the challenges associated with injectable therapies. If marketing approval is granted for MYCAPSSA®, we believe it has the potential to fundamentally change the lives of many patients for the better as the first oral somatostatin analog treatment alternative in an injectables-only market."

    Chiasma remains on track to file its NDA by year-end and expects possible FDA approval in mid-2020, following an expected six-month PDUFA review classification. In parallel, the company is conducting a Phase 3 clinical trial, MPOWEREDTM, which is designed to support an application for marketing approval in the European Union, and the company remains on track to report top-line data in the second half of 2020.

    The Acromegaly Consensus Conference is a closed, invitation-only workshop where key opinion leaders advise on evidence-based treatment guidelines for acromegaly patients.

    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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma
    Chiasma is focused on improving 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. In July 2019, the Company reported positive top-line data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.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 Company's development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, the data from the CHIASMA OPTIMAL trial and whether the data will support the submission of an NDA for octreotide capsules and ultimately regulatory approval, statements regarding the timing of NDA submission, regulatory review, including the company's anticipated eligibility for a six-month PDUFA review cycle, and potential approval, statements concerning the nature of the FDA's review of any such NDA submission and whether the data submission will be sufficient to support regulatory approval, the Company's efforts to potentially obtain regulatory approval in the European Union by conducting the ongoing MPOWERED Phase 3 clinical trial, the timing of receipt and announcement of top-line and other clinical data and submission of regulatory filings, the Company's ability to release top-line data from the MPOWERED trial during the second half of 2020, and statements concerning the therapeutic potential and the ability to become a standard of care of MYCAPSSA, if approved. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2018, 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.

    Corporate Contact:
    Dawn Schottlandt
    Vice President, Investor Relations and Corporate Communications
    617-928-5208

    Investor Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-775-5956

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  33. CHIASMA OPTIMAL trial, conducted under SPA and designed to support FDA approval, met the primary and all secondary endpoints

    MYCAPSSA® NDA on track for submission by year-end 2019

    MPOWEREDTM Phase 3 trial, designed to support EU approval, progressing as planned with topline data expected in 2H 2020

    WALTHAM, Mass., Nov. 05, 2019 (GLOBE NEWSWIRE) --  Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.  

    In July, Chiasma reported topline results from its CHIASMA OPTIMAL global Phase 3 clinical trial designed to support marketing approval…

    CHIASMA OPTIMAL trial, conducted under SPA and designed to support FDA approval, met the primary and all secondary endpoints

    MYCAPSSA® NDA on track for submission by year-end 2019

    MPOWEREDTM Phase 3 trial, designed to support EU approval, progressing as planned with topline data expected in 2H 2020

    WALTHAM, Mass., Nov. 05, 2019 (GLOBE NEWSWIRE) --  Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.  

    In July, Chiasma reported topline results from its CHIASMA OPTIMAL global Phase 3 clinical trial designed to support marketing approval of its oral octreotide capsules product candidate, conditionally trade named MYCAPSSA®, in the United States. The trial, which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA, met the primary and all secondary endpoints. If approved, MYCAPSSA will be the first oral somatostatin analog that we believe has the potential to change the standard of pharmacological care in the management of patients with acromegaly.  

    Key CHIASMA OPTIMAL data highlights include:

    Primary Endpoint:

    • 58% of patients on octreotide capsules maintained biochemical control (IGF-1 ≤ 1.0 x ULN) at the end of study vs. 19% on placebo (p = 0.008). We believe this data is consistent with the efficacy physicians may expect for a potential maintenance treatment for acromegaly patients.

    Secondary Endpoints:

    • Of patients who were growth hormone (GH) responders at screening, 78% of patients on octreotide capsules maintained their GH response at the end of the core study versus 30% for placebo (p=0.001)
    • Median time to loss of IGF-1 response (as defined by either >1.0 or ≥ 1.3 x ULN) was not reached (>36 Weeks) for patients on octreotide capsules vs. 16 weeks on placebo (p < 0.001)
    • 25% of patients on octreotide capsules required rescue with SSA Injections vs. 68% on placebo (p = 0.003); stated otherwise, 75% of patients on octreotide capsules completed the trial (of which 90% elected to continue into the open label extension)

    Exploratory Analysis:

    • Mean IGF-1 values across all patients treated with octreotide capsules remained within normal limits (≤ 1.0 x ULN) up to the end of oral treatment
    • 75% of patients on MYCAPSSA achieved an IGF-1 ≤ 1.1 x ULN at the end of treatment  

    Octreotide capsules appeared safe and well tolerated in the study population, and no new or unexpected safety signals were observed.

    Chiasma remains on track to file its NDA by year end and expects possible FDA approval in mid-2020, following an expected six-month PDUFA review classification. In parallel, the company is conducting a Phase 3 study, MPOWEREDTM, which is designed to support an application for marketing approval in the European Union, and the company remains on track to report topline data in the second half of 2020.

    In September, Chiasma hosted a Key Opinion Leader meeting for investors featuring Susan L. Samson, MD, PhD, FRCPC, FACE, Associate Professor at Baylor College of Medicine in Houston, Texas, and Jill Sisco, President of Acromegaly Community, Inc., a patient organization that helps educate patients and their families regarding this rare disease. The presentation by Dr. Samson and Ms. Sisco, which is available under the events and presentations section of the company's website, underscored the burdens that persist with the current standard-of-care, monthly SSA injections, including injection site pain and reactions. If marketing approval is granted by the FDA, MYCAPSSA would be the first approved oral somatostatin analog treatment in an injectables-only adult acromegaly maintenance treatment market. 

    "In our CHIASMA OPTIMAL trial, 90% of the patients who completed the trial on MYCAPSSA elected to continue into the open label extension, which we believe reflects the strong preference by acromegaly patients for an oral treatment option. We also observed that 75% of patients on MYCAPSSA achieved an IGF-1 ≤ 1.1 x ULN at the end of treatment, which we believe will be clinically meaningful to physicians.  If approved, we believe MYCAPSSA would be well positioned to potentially become a new standard of pharmacological care for the management of acromegaly," said Raj Kannan, Chief Executive Officer of Chiasma. "We made significant progress in the third quarter with our commercial preparedness and have hired key talent in marketing and market access and also accelerated our hiring in medical affairs" Mr. Kannan concluded.

    Third Quarter 2019 Financial Results

    • G&A Expenses: General and administrative expenses were $4.1 million for the third quarter ended September 30, 2019, compared with $2.3 million for the same period of 2018. The current period results include increased compensation related expenses, the initiation of pre-commercial activities, and increased insurance premiums which were primarily offset by a reduction in legal costs.
    • R&D Expenses: Research and development expenses were $4.1 million for the third quarter ended September 30, 2019, compared with $5.5 million for the same period of 2018. The decrease was primarily driven by a decrease in clinical trial costs and was offset by increased manufacturing and regulatory costs.
    • Net Loss: For the quarter ended September 30, 2019, net loss was ($7.7) million, or ($0.20) per basic share, compared with ($7.5) million, or ($0.31) per basic share, in the same period of 2018.
    • Financial Position: In August, Chiasma completed a follow-on offering of common stock that raised net proceeds of approximately $52.3 million.  Chiasma ended the third quarter with cash, cash equivalents and marketable securities of $102.7 million. 

    Conference Call and Webcast Information:

    Chiasma management will host a conference call and webcast to discuss the third quarter results in more detail today, November 5, 2019, at 5:00 pm EST. The dial-in number in the U.S. / Canada is 855-327-6837; for international participants, the number is 631-891-4304.  For all callers, please refer to Conference ID 10007821. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=136495

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, http://ir.chiasmapharma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    CHIASMA OPTIMAL Trial Design
    The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules that was conducted under a special protocol assessment, or SPA, agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling two capsules in the morning and two capsules in the evening. Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures and reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ≥ 1.3 × ULN; and proportion of patients requiring rescue treatment.

    MPOWERED™ Phase 3 Trial

    Chiasma is also conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the Company's 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 second half of 2020.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the Company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly-owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.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 Company's development and potential commercialization of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, the data from the CHIASMA OPTIMAL trial and whether the data will support the submission of an NDA for octreotide capsules and ultimately regulatory approval, statements regarding the timing of NDA submission and regulatory review, including the company's anticipated eligibility for a six-month PDUFA review cycle, statements concerning the nature of the FDA's review of any such NDA submission and whether the data submission will be sufficient to support regulatory approval, the Company's efforts to potentially obtain regulatory approval in the European Union by conducting the ongoing MPOWERED Phase 3 clinical trial, the timing of receipt and announcement of top-line and other clinical data and submission of regulatory filings, the Company's ability to release top-line data from the MPOWERED trial during the second half of 2020, and statements concerning the market potential and the ability to become a standard of care of MYCAPSSA. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2018, 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.

    Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-775-5956



    Chiasma, Inc.
    Condensed Consolidated Statements of Operations
    (amounts in thousands except share and per share data)
    (unaudited)
                   
      For the three months ended   For the nine months ended
      September 30, 2019   September 30, 2018   September 30, 2019   September 30, 2018
    Operating expenses:              
    General and administrative $ 4,116     $ 2,256     $ 9,210     $ 7,317  
    Research and development   4,110       5,462       16,103       16,630  
    Total operating expenses   8,226       7,718       25,313       23,947  
    Loss from operations   (8,226 )     (7,718 )     (25,313 )     (23,947 )
    Other income, net   (549 )     (275 )     (1,074 )     (785 )
    Loss before income taxes   (7,677 )     (7,443 )     (24,239 )     (23,162 )
    Provision for income taxes   6       27       34       24  
    Net loss $ (7,683 )   $ (7,470 )   $ (24,273 )   $ (23,186 )
                   
    Earnings per share of common stock:              
      Basic $ (0.20 )   $ (0.31 )   $ (0.77 )   $ (0.95 )
      Diluted $ (0.20 )   $ (0.31 )   $ (0.77 )   $ (0.95 )
                   
    Weighted-average shares outstanding:              
      Basic   38,490,768       24,389,666       31,569,731       24,385,328  
      Diluted   38,490,768       24,389,666       31,569,731       24,385,328  
                   


    Chiasma, Inc.  
    Condensed Consolidated Balance Sheets Information  
    (amounts in thousands)  
    (unaudited)  
             
      September 30, 2019   December 31, 2018  
             
    Cash and cash equivalents $ 19,665   $ 13,060  
    Marketable securities   83,030     28,602  
    Insurance recovery   -     18,288  
    Prepaid expenses and other current assets   2,987     2,237  
    Property and equipment, net   209     111  
    Other assets   992     958  
    Total assets $ 106,883   $ 63,256  
             
    Accounts payable $ 2,737   $ 2,029  
    Estimated settlement liability   -     18,750  
    Accrued expenses   6,557     7,848  
    Other current liabilities   204     -  
    Long-term liabilities   645     505  
    Total liabilities   10,143     29,132  
    Total stockholders' equity   96,740     34,124  
    Total liabilities and stockholders' equity $ 106,883   $ 63,256  
             

     

     

     

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  34. WALTHAM, Mass., Nov. 01, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today recognizes November 1st as Acromegaly Awareness Day.   

    "We recognize Acromegaly Awareness Day each year to call attention to this rare and debilitating disease, and to highlight the significant treatment burdens faced by patients and their families and the need for new maintenance treatment options," said Raj Kannan, Chief Executive Officer of Chiasma. "On this Acromegaly Awareness Day, we would like to extend our appreciation to the investigators and patients who have participated or are participating in our completed and ongoing…

    WALTHAM, Mass., Nov. 01, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today recognizes November 1st as Acromegaly Awareness Day.   

    "We recognize Acromegaly Awareness Day each year to call attention to this rare and debilitating disease, and to highlight the significant treatment burdens faced by patients and their families and the need for new maintenance treatment options," said Raj Kannan, Chief Executive Officer of Chiasma. "On this Acromegaly Awareness Day, we would like to extend our appreciation to the investigators and patients who have participated or are participating in our completed and ongoing Phase 3 clinical trials of a potential oral somatostatin analog treatment option."

    "Today, the Acromegaly Community is pleased to recognize Acromegaly Awareness Day, which reflects on our mission to provide an emotional and communal support network for people touched by acromegaly," said Jill Sisco, President of the Acromegaly Community. "In addition, we would like to acknowledge companies that are researching and developing new drug candidates that, if approved, may have the potential to improve the lives of patients with acromegaly."

    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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.

    About Chiasma
    Chiasma is focused on improving 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. In July 2019, the Company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named Mycapssa, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly owned subsidiary in Israel. Mycapssa, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.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 Company's development of octreotide capsules, conditionally named Mycapssa, for the treatment of acromegaly, including the therapeutic potential of Mycapssa, if approved.  Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Annual Report on Form 10-K for the year ended December 31, 2018, 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.

    Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-430-7577

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  35. WALTHAM, Mass., Sept. 25, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that Raj Kannan, Chief Executive Officer and Dr. William Ludlam, Senior Vice President of Clinical Development and Medical Affairs, will present a corporate overview at the Cantor 2019 Global Healthcare Conference, which is being held October 2-4  in New York City.

    Management is scheduled to present on Wednesday, October 2nd at 9:30am Eastern Time. To access a live webcast of the presentation, please use the following link: http://wsw.com/webcast/cantor10/chma/

    About Chiasma
    Chiasma is focused on improving the lives of patients…

    WALTHAM, Mass., Sept. 25, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that Raj Kannan, Chief Executive Officer and Dr. William Ludlam, Senior Vice President of Clinical Development and Medical Affairs, will present a corporate overview at the Cantor 2019 Global Healthcare Conference, which is being held October 2-4  in New York City.

    Management is scheduled to present on Wednesday, October 2nd at 9:30am Eastern Time. To access a live webcast of the presentation, please use the following link: http://wsw.com/webcast/cantor10/chma/

    About Chiasma
    Chiasma is focused on improving 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. In July 2019, the Company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named Mycapssa, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly owned subsidiary in Israel. Mycapssa, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.chiasma.com.

    Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-535-7742

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  36. WALTHAM, Mass., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, will host a Key Opinion Leader (KOL) breakfast on maintenance therapy of adult patients with acromegaly on Thursday, September 12, 2019 in New York City.

    The meeting will feature a presentation by KOL Susan Samson, MD, PhD, from the Pituitary Center at Baylor St. Luke's Medical Center, and Jill Sisco, from the Acromegaly Community, who will discuss the current treatment landscape, as well as the unmet medical need for treating adults with acromegaly. Dr. Samson and Ms. Sisco will be available to answer questions at the conclusion of the…

    WALTHAM, Mass., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, will host a Key Opinion Leader (KOL) breakfast on maintenance therapy of adult patients with acromegaly on Thursday, September 12, 2019 in New York City.

    The meeting will feature a presentation by KOL Susan Samson, MD, PhD, from the Pituitary Center at Baylor St. Luke's Medical Center, and Jill Sisco, from the Acromegaly Community, who will discuss the current treatment landscape, as well as the unmet medical need for treating adults with acromegaly. Dr. Samson and Ms. Sisco will be available to answer questions at the conclusion of the presentation.

    The Company's management team will also provide a brief overview of the business, including its product candidate, octreotide capsules for the maintenance therapy of adult patients with acromegaly, conditionally trade named Mycapssa®.

    Susan L. Samson, MD, PhD, FRCPC, FACE, is a tenured Associate Professor at Baylor College of Medicine in Houston, Texas. She is originally from Canada and completed her medical degree at Queen's University in Kingston, Ontario, and Internal Medicine training in her hometown of Calgary, Alberta. She moved to Baylor for Endocrinology fellowship training, where she was brought onto the faculty. Currently, she leads one of the largest ACGME accredited Endocrinology fellowships in the country, and she has trained over 60 endocrinology fellows during her time as Associate Program Director and Program Director. She also serves nationally as the Secretary-Treasurer of the Council of the American Program Directors of Endocrinology and Metabolism and has been a member of the ABIM Self-Assessment Committee, and now the ABIM Item Writing Task Force, and the ACGME Milestones committee. She has been awarded the Fulbright and Jaworski L.L.P. Faculty Excellence Award for Teaching and Evaluation as well as the Rising Star award at Baylor College of Medicine in its inaugural year. Dr. Samson co-founded The Pituitary Center at Baylor College of Medicine in 2010, which has grown to a multistate, high volume referral center for pituitary disorders. Dr. Samson is a site principal investigator for several clinical trials in the areas of Cushing's syndrome, Acromegaly and Growth Hormone deficiency. She is on the Board of Directors of the American Association of Clinical Endocrinologists 2016-2019 and has been re-elected to a second term 2019-2022 and is a Member at Large of the Board of Trustees of the American College of Endocrinology.

    Jill Sisco is President of Acromegaly Community, Inc., a patient organization that helps educate patients and loved ones regarding this rare disease and provides guidance on how to cope with their difficult illness. Since her diagnosis in 2005 Jill has been an influential advocate towards a better quality of life for Acromegaly patients worldwide. In 2008, Jill became a leader in patient advocacy and has sat on several Acromegaly advisory boards. Jill has presented the patient perspective to FDA, co-authored several medical journal articles and abstracts regarding Acromegaly, and manages the widely visited patient community website and social media support groups. By organizing and hosting the biennial International Acromegaly Community Conference which engages patients, specialists, and pharmaceutical companies, Jill shows how passionate she is about providing an emotional and communal support network for people touched by acromegaly. She works tirelessly to enable forward thinking that will facilitate research, assist patients with their treatment plans and provide positive outcomes for the future of acromegaly patients everywhere. Jill is highly respected in her community and has been a pioneer in building awareness around Acromegaly. Through her dedication Jill leads by example and is a proponent of patients taking control of their lives and their disease and advocating for their best health possible.

    This event is intended for institutional investors, sell-side analysts, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. Members of the media and the public are invited to participate via the live webcast.

    About Chiasma

    Chiasma is focused on improving 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. In July 2019, the Company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named Mycapssa, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly-owned subsidiary in Israel. Mycapssa, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.chiasma.com.

    Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-535-7742

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  37. WALTHAM, Mass., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that Raj Kannan, Chief Executive Officer and Dr. William Ludlam, Senior Vice President of Clinical Development and Medical Affairs, will present a corporate overview at the H.C. Wainwright 21st Annual Global Investment Conference, which is being held September 8-10 in New York. Management is scheduled to present on Tuesday, September 10 from 9:10-9:35am ET.

    About Chiasma
    Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases…

    WALTHAM, Mass., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that Raj Kannan, Chief Executive Officer and Dr. William Ludlam, Senior Vice President of Clinical Development and Medical Affairs, will present a corporate overview at the H.C. Wainwright 21st Annual Global Investment Conference, which is being held September 8-10 in New York. Management is scheduled to present on Tuesday, September 10 from 9:10-9:35am ET.

    About Chiasma
    Chiasma is focused on improving 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. In July 2019, the Company reported positive topline data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named Mycapssa, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, The Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, MA with a wholly owned subsidiary in Israel. Mycapssa, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company's website at www.chiasma.com.

    Contact:
    Ashley R. Robinson
    LifeSci Advisors, LLC
    617-535-7742

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  38. Mark Leuchtenberger joins Board as Executive Chairman

    Eva-Lotta Allan appointed as Non-Executive Director

    Aleta Biotherapeutics, a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, today announced the appointments of Mark Leuchtenberger as Executive Chairman and Eva-Lotta Allan as Non-Executive Director effective immediately.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190905005187/en/

    Mark Leuchtenberger (Photo: Business Wire)

    Mark Leuchtenberger (Photo: Business Wire)

    Mark Leuchtenberger is an experienced life sciences executive, having held leadership roles at multiple companies. He is currently Interim Chief…

    Mark Leuchtenberger joins Board as Executive Chairman

    Eva-Lotta Allan appointed as Non-Executive Director

    Aleta Biotherapeutics, a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, today announced the appointments of Mark Leuchtenberger as Executive Chairman and Eva-Lotta Allan as Non-Executive Director effective immediately.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190905005187/en/

    Mark Leuchtenberger (Photo: Business Wire)

    Mark Leuchtenberger (Photo: Business Wire)

    Mark Leuchtenberger is an experienced life sciences executive, having held leadership roles at multiple companies. He is currently Interim Chief Executive Officer at Brooklyn ImmunoTherapeutics. Mr. Leuchtenberger has over 20 years of experience as a senior executive in the biopharmaceutical industry where he has led companies through successful private financings and initial public offerings, taken products from Investigational New Drug status through to commercialization, and has achieved M&A exits.

    Eva-Lotta Allan has over 30 years of experience in the biopharmaceutical industry, most recently as Chief Business Officer at Immunocore, a clinical-stage T-cell receptor company. She has also served on a number of other Boards in both private and publicly held companies during her career. She is currently a Non-Executive Director for Targovax and Crescendo Biologics and is also Chairman of C4X Discovery.

    "Mark and Eva-Lotta bring complementary skills to the Board of Aleta that are particularly important to us at this stage in our development," said Paul Rennert, President, Co-Founder, and Chief Scientific Officer, Aleta Biotherapeutics. "Mark's experience in leading companies from early clinical development through to commercial launch will support Aleta's evolution as we move our lead program forward. Eva-Lotta's corporate and strategic track record, significant business development achievements, and broad operational experiences in growing biotech companies will help Aleta as we expand the company and establish strategic alliances in the field of oncology. We are fortunate to have these seasoned executives on our Board as we explore the potential of our proprietary fusion proteins to attack and kill tumor cells."

    Mark Leuchtenberger and Eva-Lotta Allan join Roy Lobb, Co-Founder of Aleta Biotherapeutics, Raj Parekh, General Partner at Advent Life Sciences, and Paul Rennert on the Board of Directors.

    "Aleta Biotherapeutics' bridging protein strategy has the potential to address the most critical issues in cell therapy," said Mark Leuchtenberger. "This unique approach offers the potential to confront antigen loss and tumor heterogeneity by targeting multiple antigens simultaneously with a single CD19-directed CAR. I am excited to be joining the Board and look forward to working with Paul Rennert and his team as they advance this new approach to cancer immunotherapy."

    Eva-Lotta Allan commented: "I am excited to join the Board of Aleta as the company is advancing to become a significant contributor to the immuno-oncology field based on its innovative approach to targeting tumors. Aleta is transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, including currently intractable solid tumors. I believe Aleta's experienced management team is well positioned to successfully advance this exciting new approach to treating cancer."

    Mark Leuchtenberger

    Mark Leuchtenberger, MBA has over 20 years of experience as a senior life sciences executive, during which he has led companies through multiple public and private financings and has advanced products from Investigational New Drug status through to commercialization. Previously, Mr. Leuchtenberger was President and Chief Executive Officer and a member of the Board of Directors at IRX Therapeutics, Chiasma (NASDAQ:CHMA), Acusphere, Inc., Rib-X Pharmaceuticals, Inc. (now Melinta Therapeutics, Inc.), Targanta Therapeutics Corporation, and Therion Biologics Corporation. Prior to Therion, Mr. Leuchtenberger was a senior officer at Biogen Inc., where he led the late-stage development of its flagship product Avonex and its commercialization in the United States and internationally in 65 countries. He is a Director and past Chairman of the Massachusetts Biotechnology Council Board of Directors and is a Co-Founder of Albor Biologics, Inc. and Alvos Therapeutics, Inc. Mr. Leuchtenberger received his MBA from the Yale School of Management and his BA from Wake Forest University.

    Eva-Lotta Allan

    Eva-Lotta Allan has more than 30 years of experience in the healthcare industry. During this time, she has been a senior executive and Board member at both public and private companies. Most recently, Eva-Lotta was Chief Business Officer (and previously a Board Member) at Immunocore, where she held full responsibility for all aspects of business development and played an instrumental role in the $320 million fundraising in 2015. Prior to this, Eva-Lotta served as Chief Business Officer and member of the Executive Committee and Euronext IPO team for Ablynx NV, acquired in 2018 by Sanofi for EUR 3.9 billion.

    Eva-Lotta also held senior positions at Vertex Pharmaceuticals (Europe) Ltd (now with a market capitalization of $45.3 billion), Oxford Asymmetry International plc (now Evotec with a market capitalization of EUR 2.9 billion), Oxford Glycosciences (now part of UCB Celltech with a market capitalization of EUR 12.6 billion), and Amersham International (now part of GE Healthcare).

    Eva-Lotta Allan currently serves as Non-Executive Director and Member of the Corporate Governance Committee and the R&D Sub-Committee of the Oslo listed company, Targovax ASA and is a Non-Executive Director of Crescendo Biologics and Chairman of C4X Discovery. Eva-Lotta was also a Board Member of the UK BioIndustry Association (BIA).

    About Aleta Biotherapeutics

    Aleta Biotherapeutics is an immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, including currently intractable solid tumors. The company was founded by Paul Rennert and Roy Lobb, who bring extensive scientific and leadership experience in immunology, oncology and drug development to this new enterprise. Aleta has created a unique portfolio of multi-antigen targeting solutions for cell therapy, designed to address the critical issues of CAR-T persistence, tumor antigen loss leading to patient relapse, and tumor antigen heterogeneity. For more information, visit www.aletabio.com.

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