CHMA Chiasma Inc.

3.01
-0.01  -0%
Previous Close 3.02
Open 2.99
52 Week Low 2.77
52 Week High 7.75
Market Cap $174,109,167
Shares 57,843,577
Float 51,867,728
Enterprise Value $39,266,602
Volume 535,536
Av. Daily Volume 1,787,584
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly
Phase 3
Phase 3
Phase 3 trial met primary non-inferiority endpoint - November 18, 2020.
Mycapssa - OPTIMAL
Acromegaly
Approved
Approved
FDA approval announced June 26, 2020.
Mycapssa
Acromegaly
CRL
CRL
CRL April 15 2016

Latest News

  1. --93% of all patients who enrolled as a responder to MYCAPSSA® maintained their biochemical response at the end of the 48-week open-label extension (OLE) period--

    --Safety profile during the OLE was generally consistent with the safety observed in the CHIASMA OPTIMAL trial

    NEEDHAM, Mass., March 22, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today presented…

    --93% of all patients who enrolled as a responder to MYCAPSSA® maintained their biochemical response at the end of the 48-week open-label extension (OLE) period--

    --Safety profile during the OLE was generally consistent with the safety observed in the CHIASMA OPTIMAL trial

    NEEDHAM, Mass., March 22, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today presented long-term safety and efficacy data from the first 48 weeks of the open-label extension (OLE) of the Phase 3 CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) trial of MYCAPSSA (octreotide capsules) at the Endocrine Society's annual meeting, ENDO 2021, being held virtually March 20-23, 2021.

    "These long-term safety and efficacy data demonstrate that MYCAPSSA maintains insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly who previously required monthly injections for their disease," said Susan L. Samson, M.D., Ph.D., FRCPC, FACE, principal investigator of the trial. "The fact that 90% of the patients receiving MYCAPSSA in the CHIASMA OPTIMAL trial elected to enroll in the OLE demonstrates strong patient preference for MYCAPSSA."

    Results from the ongoing OLE study show that the average IGF-1 levels of all patients (n=19) treated with MYCAPSSA who completed the double-blind placebo-controlled (DPC) period in the CHIASMA OPTIMAL trial and continued into the OLE were maintained within normal limits at the end of the 48-week OLE period (0.91 at baseline and 0.90 × upper limit of normal (ULN) at week 48). All patients who responded to MYCAPSSA (IGF within normal limits) during the DPC period and enrolled in the OLE (n=14) completed the 48-week period and 93% (13/14) maintained their IGF-1 response within the normal limit at the end of this period. The safety profile of MYCAPSSA observed during the OLE was generally consistent with the safety observed in the CHIASMA OPTIMAL trial with the number of adverse events decreasing over the time of the OLE.

    Raj Kannan, Chief Executive Officer of Chiasma, added, "The long-term durability of response seen with the 48-week open label extension study further supports our belief in MYCAPSSA's potential to become the new standard of pharmacological care for patients with acromegaly."

    About the CHIASMA OPTIMAL 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 was designed to evaluate the proportion of patients who maintain their biochemical response to MYCAPSSA® (oral octreotide capsules) compared to placebo. 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 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 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. 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, 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

    View Full Article Hide Full Article
  2. --Data supports MYCAPSSA® as non-inferior to long-acting injectable somatostatin receptor ligands (iSRLs)--

    --Data demonstrated patients taking MYCAPSSA had significant improvement in acromegaly related symptoms and patient reported outcomes after switching from iSRLs--

    NEEDHAM, Mass., March 20, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today announced…

    --Data supports MYCAPSSA® as non-inferior to long-acting injectable somatostatin receptor ligands (iSRLs)--

    --Data demonstrated patients taking MYCAPSSA had significant improvement in acromegaly related symptoms and patient reported outcomes after switching from iSRLs--

    NEEDHAM, Mass., March 20, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today announced the presentation of new positive clinical data from its MPOWERED™ Phase 3 trial of MYCAPSSA at the Endocrine Society's annual meeting, ENDO 2021, being held virtually March 20-23, 2021. The data from MPOWERED showed that MYCAPSSA improved clinical symptoms and other patient-reported outcomes compared to long-acting injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly. In addition, MYCAPSSA met the pre-specified non-inferiority margin compared to long-acting iSRLs in maintenance of biochemical response.

    "The new encouraging data from all five late-breaking poster presentations further expand our understanding of oral octreotide capsules' potential positive impact for patients with acromegaly who would otherwise need monthly, frequently burdensome SRLs injections," said Maria Fleseriu, M.D., 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, and Immediate Past President of the Pituitary Society. "As a practicing endocrinologist, I believe that these data provide valuable insights to physicians on the potential benefit of a twice daily oral drug versus long-acting injections for most patients."

    Raj Kannan, Chief Executive Officer of Chiasma, added, "We are pleased to characterize further the MYCAPSSA product profile with the positive results from Chiasma's MPOWERED study at ENDO 2021 for the medical community. This is the first head-to-head large, non-inferiority Phase 3 trial in acromegaly that has been done to assess safety and efficacy, including the effect on acromegaly symptoms, and on patient satisfaction. Based on these data, we remain focused on submitting a marketing authorization application for MYCAPSSA to the European Medicines Agency planned for mid-2021."

    Data highlights from the five late-breaking poster presentations are outlined below:

    A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules In Comparison to Injectable Somatostatin Receptor Ligands

    • Data showed that MYCAPSSA demonstrated non-inferiority to iSRLs in maintaining biochemical response, 91% (CI, 80%-97%) of the MYCAPSSA patients maintained insulin-like growth factor 1 (IGF-1) response during the randomized controlled treatment (RCT) phase.
    • MYCAPSSA demonstrated stable IGF-1 levels during the RCT phase comparable to iSRLs, supporting efficacy of MYCAPSSA.

    Oral Octreotide Capsules Lowered Incidence and Improved Severity of Acromegaly Symptoms Compared to Injectable Somatostatin Receptor Ligands—Results from the MPOWERED Trial

    • A statistically significant (p = 0.001) reduction from baseline (time of first dose of MYCAPSSA in run-in) was noted in the number of active acromegaly symptoms. Reduction in the number of active symptoms by individual symptom was statistically significant for swelling of extremities (p = 0.01) and fatigue (p = 0.03).
    • The overall mean symptom score decreased from 4.5 to 3.5; the mean change from baseline was statistically significant (p < 0.001) and clinically meaningful (> 1 point reduction is equal to a shift of 1 symptom from severe to moderate, or moderate to mild or resolution of 1 symptom).
    • Overall, 80.4% of the randomized patients maintained or improved their symptoms score during the run-in phase compared to baseline.
    • We believe these findings validate previous results from the open-label, Phase 3 CH-ACM-01 study of MYCAPSSA in which patients switching to MYCAPSSA from iSRLs reported significant reduction in joint pain, extremity swelling and fatigue.

    Improved Acromegaly Patient Satisfaction with Oral Octreotide Capsules Compared with Injectable Somatostatin Receptor Ligands in The MPOWERED Trial

    • For the 92 patients randomized, 3 of 5 domains (emotional reaction, treatment convenience, and treatment satisfaction) of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) showed significant improvement at the end of the run-in (n=37) phase (reflecting outcomes on MYCAPSSA) as compared to baseline (reflecting outcomes on iSRLs). Improvements not reaching statistical significance were also noted for symptom interference and GI interference.
    • Patients receiving MYCAPSSA demonstrated a significant improvement in the Acro-TSQ domain of treatment convenience over the RCT phase in comparison to those receiving iSRLs (p = 0.04).
    • At the end of the RCT phase, breakthrough acromegaly symptoms were reported by 15% of patients in octreotide capsules group and 31% of patients in the iSRLs group.
    • Of note, 47% of patients receiving SRL injections during the RCT phase reported injection site reactions via the Acro-TSQ. 81% of these patients reported that iSLRs interfered with their daily activities.

    Addition of Cabergoline to Oral Octreotide Capsules May Improve Biochemical Control in Patients with Acromegaly Who Are Inadequately Controlled with Monotherapy

    • IGF-1 levels improved in most patients over the 36-week study (n=12; 85.7%).
    • Of nine patients with IGF-1 ≥1.3 × ULN at sub-study start, five patients (55.6%; 95% CI, 21.2% -86.3%) exhibited decreases to predefined responder range (<1.3 × ULN) by week 36.
    • Adverse event incidence and nature were similar to the known octreotide safety profile and acromegaly disease burden.
    • For the first time, a study demonstrated the potential benefit of an all-oral combination treatment for acromegaly with avoidance of injection-related burdens.

    Safety Results From MPOWERED, A Phase 3 Trial of Oral Octreotide Capsules in Adults with Acromegaly

    • No new or unexpected safety signals were identified during the trial.
    • 39 patients (70.9%) in the MYCAPSSA group and 26 (70.3%) in the iSRL group had ≥1 treatment-emergent adverse events (TEAE). Gastrointestinal AEs were the most common TEAEs within both groups.
    • Safety results were similar between both groups, but the MYCAPSSA group did not have injection site reactions, whereas 24.3% of patients reported injection site reactions as TEAEs from the iSRL group during the RCT phase.

    About the CHIASMA MPOWERED™ Trial

    The MPOWERED™ trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA® (oral octreotide capsules) in the European Union. This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The trial enrolled 146 adult acromegaly patients of which 92 patients who were responders to MYCAPSSA after a six-month run-in phase were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy. Patients were randomized to either MYCAPSSA (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 primary endpoint of the trial was time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the nine-month randomized, controlled treatment (RCT) phase. As previously announced, MPOWERED met its primary endpoint of non-inferiority compared to long acting SSA injectables.



    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 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 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 Annual Report on Form 10-K for the year ended December 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

    View Full Article Hide Full Article
  3. -- One oral presentation and five late-breaking posters accepted --

    NEEDHAM, Mass., March 10, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent approval of MYCAPSSA as the first and only oral therapy for the treatment of acromegaly, today announced that it will be presenting data from two Phase 3 clinical trials: the open-label extension of the CHIASMA OPTIMAL study and the MPOWERED™ study, at the Endocrine Society's annual meeting, ENDO 2021…

    -- One oral presentation and five late-breaking posters accepted --

    NEEDHAM, Mass., March 10, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent approval of MYCAPSSA as the first and only oral therapy for the treatment of acromegaly, today announced that it will be presenting data from two Phase 3 clinical trials: the open-label extension of the CHIASMA OPTIMAL study and the MPOWERED™ study, at the Endocrine Society's annual meeting, ENDO 2021. The conference will be held virtually from March 20-23, 2021.

    Chiasma is proud to be a platinum sponsor of the conference and will have a virtual booth available where registrants can find more information. The Company has also provided an unrestricted educational grant to support the continuing medical education (CME) program "Acromegaly: Novel Therapeutic Options to Alleviate Treatment Burden and Improve Patient Quality of Life" sponsored by Vindico Medical Education scheduled for Sunday, March 21 at 5:30 p.m. ET. This program will feature a faculty of experts and leaders in the pituitary and acromegaly space including Drs. Eliza Geer, Maria Fleseriu and Adriana Ioachimescu.

    Abstracts selected for presentation are summarized below. The posters will be available online through April 30, 2021.

    Oral Presentation

    Title: One-Year Outcomes of the Open-Label Extension of CHIASMA OPTIMAL, a Phase 3 Study of Oral Octreotide Capsules in Acromegaly

    Presenter: Susan L. Samson, M.D., Ph.D., FRCPC, FACE, Mayo Clinic in Florida

    Session Date/Time: Monday, March 22, 2021, 2:30 p.m. – 2:40 p.m. EDT

    Late-Breaking Poster Presentations

    Title: Oral Octreotide Capsules Lowered Incidence and Improved Severity of Acromegaly Symptoms Compared to Injectable Somatostatin Receptor Ligands—Results from the MPOWERED Trial

    Presenter: Nienke Biermasz, M.D., Ph.D., Leiden University Medical Center

    Session Date/Time: Saturday, March 20, 2021, 11:00 a.m.-11:50 p.m. EDT

    Title: Safety Results from MPOWERED, a Phase 3 Trial of Oral Octreotide Capsules in Adults with Acromegaly

    Presenter: Pamela Freda, M.D., Columbia University

    Session Date/Time: Saturday, March 20, 2021, 11:00 a.m.-11:50 p.m. EDT

    Title: Improved Acromegaly Patient Satisfaction with Oral Octreotide Capsules Compared with Injectable Somatostatin Receptor Ligands in the MPOWERED Trial

    Presenter: Murray B. Gordon, M.D., Allegheny General Hospital

    Session Date/Time: Saturday, March 20, 2021, 11:00 a.m.-11:50 p.m. EDT

    Title: A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor Ligands

    Presenter: Maria Fleseriu, M.D., FACE, Oregon Health & Science University Northwest Pituitary Center

    Session Date/Time: Saturday, March 20, 2021, 11:00 a.m.-11:50 p.m. EDT

    Title: Addition of Cabergoline to Oral Octreotide Capsules May Improve Biochemical Control in Patients with Acromegaly Who Are Inadequately Controlled with Monotherapy

    Presenter: Maria Fleseriu, M.D., FACE, Oregon Health & Science University Northwest Pituitary Center

    Session Date/Time: Saturday, March 20, 2021, 11:00 a.m.-11:50 p.m. EDT

    To register and view the full schedule as well as abstracts, visit the Endocrine Society's website: www.endocrine.org/meetings-and-events/endo2021.

    About the CHIASMA OPTIMAL 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 was designed to evaluate the proportion of patients who maintain their biochemical response to MYCAPSSA® (oral octreotide capsules) compared to placebo. 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. 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 the CHIASMA MPOWERED Trial

    The MPOWERED™ trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA® (oral octreotide capsules) in the European Union. This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The trial enrolled 146 adult acromegaly patients of which 92 patients who were responders to MYCAPSSA after a six-month run-in phase were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy. Patients were randomized to either MYCAPSSA (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 primary endpoint of the trial was time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the nine-month randomized, controlled treatment (RCT) phase. As previously announced, MPOWERED met its primary endpoint of non-inferiority compared to long acting SSA injectables.

    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 therapeutic potential 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 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, 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

    View Full Article Hide Full Article
  4. Phased launch of MYCAPSSA® progressing with 2020 net product revenue of $1.1 million

    Achieved payor coverage of MYCAPSSA for over 150 million lives

    Company to host conference call today, March 4, 2021 at 5:00pm ET

    NEEDHAM, Mass., March 04, 2021 (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 initiation of a phased U.S. commercial launch of MYCAPSSA® as the first oral therapy for treatment of acromegaly, today announced financial results for the fourth quarter and year ended December 31, 2020 and provided a…

    Phased launch of MYCAPSSA® progressing with 2020 net product revenue of $1.1 million

    Achieved payor coverage of MYCAPSSA for over 150 million lives

    Company to host conference call today, March 4, 2021 at 5:00pm ET

    NEEDHAM, Mass., March 04, 2021 (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 initiation of a phased U.S. commercial launch of MYCAPSSA® as the first oral therapy for treatment of acromegaly, today announced financial results for the fourth quarter and year ended December 31, 2020 and provided a business update.

    Recent Business Highlights

    • Commenced U.S. phased launch of MYCAPSSA® in September 2020 with reported 2020 net product revenue of $1.1 million, primarily from the fourth quarter
    • Secured payor coverage of MYCAPSSA for over 150 million lives in 2020
    • Demonstrated non-inferiority of MYCAPSSA to long-acting injectable somatostatin analogs for maintenance of biochemical response in patients with acromegaly in the top-line results of the MPOWERED Phase 3 study
    • Enrolled over 200 acromegaly patients to date, requiring long-term medical therapy into the MACRO disease state registry denoting strong interest in understanding the current state of care
    • Complemented the management team with the appointment of John Doyle as Chief Financial Officer
    • Exited the fourth quarter with $135.4 million of cash, cash equivalents and marketable securities (exclusive of approximately $20.6 million of restricted cash)

    Anticipated Upcoming 2021 Milestones

    • Continued growth of MYCAPSSA revenue by building on the U.S. commercial launch progress achieved to date and the planned expansion of the commercial team in 2021 when market conditions warrant
    • Presentation of five accepted late-breaker abstracts from the MPOWERED Phase 3 Study planned at the upcoming virtual 2021 Endocrine Society Annual Meeting (ENDO) later this month
    • Oral presentation on longer-term efficacy and safety data from the open-label extension of the CHIASMA OPTIMAL Phase 3 trial planned for the upcoming virtual 2021 ENDO Meeting

    • Planned submission of the MPOWERED Study results to a peer-reviewed medical journal in 2021

    • Submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA seeking EU regulatory approval planned for mid-2021

    "We continue to gain traction with our phased launch of MYCAPSSA and are encouraged by the positive feedback from physicians and patients," stated Raj Kannan, Chief Executive Officer of Chiasma. "We made significant progress with payors in covering over 150 million lives, and we have implemented a number of innovative initiatives to both educate our customers and support patients who want to switch to MYCAPSSA."

    "With respect to the COVID-19 pandemic we have continued to experience a challenging environment with reduced patient visits to their physicians and limited access to customers for our commercial team. In anticipation of some of these headwinds, we implemented digital and virtual programs and also phased the hiring of our customer-facing team with the final phase of hiring planned for when market conditions warrant," concluded Mr. Kannan.

    Fourth Quarter and Full-Year 2020 Financial Results

    Product Revenue, Net: Net product revenue related to the sales of MYCAPSSA were approximately $1.0 million for the fourth quarter of 2020 marking MYCAPSSA's first full quarter of sales. Net product revenue related to the sales of MYCAPSSA for the year ended December 31, 2020 were $1.1 million following the September 2020 launch.

    SG&A Expenses: Selling, general and administrative expenses were $13.6 million for the fourth quarter of 2020 and $44.9 million for 2020, compared to $5.9 million for the fourth quarter of 2019 and $15.1 million for 2019. The increase of $7.7 million and $29.8 million, respectively, was driven by commercial activities, an increase in personnel-related expenses, and other administrative costs to support the commercialization of MYCAPSSA in the U.S.

    R&D Expenses: Research and development expenses were $4.5 million for the fourth quarter of 2020 compared to $6.4 million for the fourth quarter of 2019. The decrease of $1.9 million was primarily driven by a decrease in clinical trial expenses. Research and development expenses for 2020 were $26.8 million compared to $22.5 million for 2019. The increase of $4.3 million was primarily related to the manufacturing of MYCAPSSA to support our U.S. commercial launch, which were expensed prior to FDA approval.

    Net Loss: Net loss for the fourth quarter of 2020 was ($19.8) million, or ($0.32) per basic share, as compared with ($12.0) million, or ($0.29) per basic share for the fourth quarter of 2019. Net loss for 2020 was ($74.8) million, or ($1.43) per basic share, as compared with ($36.3) million, or ($1.06) per basic share, for 2019.

    Cash Position: Chiasma ended 2020 with cash, cash equivalents, and marketable securities of $135.4 million (excluding $20.6 million of restricted cash), as compared with $92.4 million for the year ended December 31, 2019.

    2021 Financial Guidance: As previously stated, operating expenses for the full year 2021 are 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 expenditures related to potential EU launch preparations of MYCAPSSA or additional new development programs.

    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 4, 2021, at 5:00 pm 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 13715763. To access the live webcast, please use the following link: 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 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 potential market adoption and commercial success, 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 continued 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 Annual Report on Form 10-K for the year ended December 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





    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, 2020 December 31, 2019 December 31, 2020 December 31, 2019 
    Product revenue, net$964  $  $1,106  $  
    Cost of goods sold 58      61     
    Gross Profit 906      1,045     
    Operating expenses:        
    Selling, general and administrative 13,597   5,912   44,892   15,122  
    Research and development 4,482   6,354   26,802   22,457  
    Total operating expenses 18,079   12,266   71,694   37,579  
    Loss from operations (17,173)  (12,266)  (70,649)  (37,579) 
    Interest and other income, net 178   469   1,826   1,543  
    Interest expense (2,839)     (5,872)    
    Loss before income taxes (19,834)  (11,797)  (74,695)  (36,036) 
    Provision (benefit) for income taxes (26)  250   84   284  
    Net loss$(19,808) $(12,047) $(74,779) $(36,320) 
             
    Earnings per share of common stock:        
    Basic$(0.32) $(0.29) $(1.43) $(1.06) 
    Diluted$(0.32) $(0.29) $(1.43) $(1.06) 
             
    Weighted-average shares outstanding:        
    Basic 62,807,536   42,022,030   52,234,945   34,204,284  
    Diluted 62,807,536   42,022,030   52,234,945   34,204,284  
             



    Chiasma, Inc.  
    Condensed Consolidated Balance Sheets Information 
    (amounts in thousands)  
    (unaudited) 
         
     December 31, 2020 December 31, 2019 
         
    Cash and cash equivalents$15,462 $27,855 
    Marketable securities 119,959  64,520 
    Accounts receivable 538  - 
    Inventory 10,955  - 
    Prepaid expenses and other current assets 6,444  3,881 
    Property and equipment, net 534  334 
    Other assets 1,883  2,236 
    Restricted cash 20,563  - 
    Total assets$176,338 $98,826 
         
    Accounts payable$4,240 $3,253 
    Accrued expenses 11,858  7,576 
    Other current liabilities 633  546 
    Deferred royalty obligation 63,548  - 
    Long-term liabilities 4,274  1,682 
    Total liabilities 84,553  13,057 
    Total stockholders' equity 91,785  85,769 
    Total liabilities and stockholders' equity$176,338 $98,826 
         


    Primary Logo

    View Full Article Hide Full Article
  5. 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

     



    Primary Logo

    View Full Article Hide Full Article
View All Chiasma Inc. News