Chiasma Reports Third Quarter 2019 Results
CHIASMA OPTIMAL trial, conducted under SPA and designed to support
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
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
Key CHIASMA OPTIMAL data highlights include:
- 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.
- 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)
- 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
In September, Chiasma hosted a Key Opinion Leader meeting for investors featuring
“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 millionfor the third quarter ended September 30, 2019, compared with $2.3 millionfor 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 millionfor the third quarter ended September 30, 2019, compared with $5.5 millionfor 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. /
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
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
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
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
LifeSci Advisors, LLC
|Condensed Consolidated Statements of Operations|
|(amounts in thousands except share and per share data)|
|For the three months ended||For the nine months ended|
|September 30, 2019||September 30, 2018||September 30, 2019||September 30, 2018|
|General and administrative||$||4,116||$||2,256||$||9,210||$||7,317|
|Research and development||4,110||5,462||16,103||16,630|
|Total operating expenses||8,226||7,718||25,313||23,947|
|Loss from operations||(8,226||)||(7,718||)||(25,313||)||(23,947||)|
|Other income, net||(549||)||(275||)||(1,074||)||(785||)|
|Loss before income taxes||(7,677||)||(7,443||)||(24,239||)||(23,162||)|
|Provision for income taxes||6||27||34||24|
|Earnings per share of common stock:|
|Weighted-average shares outstanding:|
|Condensed Consolidated Balance Sheets Information|
|(amounts in thousands)|
|September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||19,665||$||13,060|
|Prepaid expenses and other current assets||2,987||2,237|
|Property and equipment, net||209||111|
|Estimated settlement liability||-||18,750|
|Other current liabilities||204||-|
|Total stockholders' equity||96,740||34,124|
|Total liabilities and stockholders' equity||$||106,883||$||63,256|
Source: Chiasma, Inc.