Constellation Pharmaceuticals Announces Third-Quarter and Nine-Month 2019 Financial Results
- First MANIFEST data showing signs of CPI-0610 clinical activity in JAK-inhibitor-naïve myelofibrosis patients
- Data showing signs of continuing activity in ruxolitinib-refractory or -intolerant patients
- Expanded MANIFEST to enroll more JAK-inhibitor-naïve patients and transfusion-dependent ruxolitinib-refractory or -intolerant patients
- MANIFEST oral presentation, poster, and investor event scheduled for
December 9at ASH
- Randomized Phase 3 clinical trial of CPI-0610 in first-line setting expected to start in 2020
- Significant additional progress being made across the Company’s portfolio
“Our clinical programs continued to advance during the third quarter,” said
Two abstracts with preliminary data from the MANIFEST clinical trial from 59 enrolled patients as of
- In Arm 3, in which we are evaluating CPI-0610 in combination with ruxolitinib in a first-line setting in JAK-inhibitor-naïve patients, all four evaluable patients experienced at least a 35% spleen volume reduction and at least a 50% reduction in total symptom score, which are the primary endpoints for these patients.
- In Arms 1 and 2, in which we are evaluating CPI-0610 in combination with ruxolitinib and as a monotherapy in a second-line setting in ruxolitinib-resistant or -intolerant patients, additional preliminary data showed continuing signs of activity across a broad range of parameters, including spleen volume reduction, patient-reported symptom improvement, hemoglobin increases, conversion to transfusion independence in transfusion-dependent patients, and bone marrow fibrosis score improvement, consistent with preliminary data presented at
ASCOand EHA in June.
- In Arms 1 and 2, conversions to transfusion independence increased from two as of
April 17, 2019, to four as of June 27, 2019. Data from 12 additional patients are being monitored for possible additional conversions.
- CPI-0610 was generally well-tolerated, both as a monotherapy or in combination with ruxolitinib. One ruxolitinib-resistant or -intolerant patient discontinued due to serious adverse event(s), which were reported as unlikely related to CPI-0610. No JAK-inhibitor-naïve patients discontinued due to adverse events. Please review the abstracts here for more details.
- The Company will present updates of clinical data from MANIFEST in oral and poster presentations at the ASH annual meeting on
December 9and will also host an investor meeting. Please read here for additional information.
- We expanded Arm 3 of MANIFEST for JAK-inhibitor-naïve patients from 43 to up to approximately 100 patients. We expanded Cohort 2A for TD ruxolitinib-refractory or -intolerant patients being treated with CPI-0610 + ruxolitinib, and we may expand Cohort 1A for TD ruxolitinib-refractory or -intolerant patients being treated with CPI-0610 monotherapy, from 16 to up to approximately 60 patients in each cohort.
- We have started planning for a potential pivotal trial with CPI-0610 for MF in the first-line setting, and we expect the trial to begin in 2020.
Constellation provided a program update on CPI-1205:
- Enrollment in the Phase 2 portion of ProSTAR is nearly complete.
- An endpoint accepted by regulatory authorities for pivotal clinical trials in prostate cancer is radiographic progression-free survival (rPFS). In addition, we learned from a study presented by the Kim Chi lab at the 2018
American Society of Clinical Oncologyannual meeting that median responses to second-line therapy generally last only a few months.
- Data from the Phase 1b portion of ProSTAR provided preliminary evidence of deep and durable effects of CPI-1205 in certain metastatic castration-resistant prostate cancer patients. We are shifting our focus in this study to durability of clinical activity with CPI-1205.
- We are gathering data on time to progression (TTP) of CPI-1205 in ProSTAR, a metric that may serve as a surrogate for rPFS and may guide future development of the compound. Determining TTP will require additional time for the data set to mature, and we expect to report these data from ProSTAR in mid-2020. Plans for any potential Phase 3 program for CPI-1205 will depend on our assessment of the Phase 2 data.
- Enrollment of patients in a Phase 1/2 clinical trial of CPI-0209 continues according to plan. Dosing began in
- CPI-0209 is a second-generation and potentially best-in-class EZH2 inhibitor that has been designed to achieve comprehensive target coverage through extended on-target residence time. The compound has demonstrated more robust anti-tumor activity compared to first-generation EZH2 inhibitors in preclinical models of multiple cancer types. We believe that CPI-0209 may enable us to address additional patient populations beyond those that we are targeting with CPI-1205 or that have been targeted by other EZH2 inhibitors.
Third Quarter 2019 Financial Results
- Cash, cash equivalents, and marketable securities as of September 30, 2019, were
$89.1 million, a decline of 22.3% compared to December 31, 2018, primarily due to operating expenses. On October 3, 2019, the Company raised gross proceeds of $65 millionin a private placement of its stock.
- Research and development (R&D) expenses increased 27.6% year over year to $16.2 million in the third quarter of 2019 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 30.7% year over year to
$4.8million in the third quarter of 2019, primarily due to building out the organization of the company.
- The net loss increased 32.7% year over year to $21.1 million for the third quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders increased 1.2% to
$0.82per share due to the increased net loss, offset in part by an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Nine Month 2019 Financial Results
- Research and development (R&D) expenses increased 48.9% year over year to $47.9 million in the first nine months of 2019, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 66.8% year over year to
$14.1million in the first nine months of 2019, primarily due to building out the organization of the company.
- The net loss increased 53.4% year over year to $61.3 million for the first nine months of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 56.3% to $2.38 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Constellation expects that its cash, cash equivalents, and marketable securities as of
Results of Operations
|Constellation Pharmaceuticals, Inc.|
|Consolidated Statements of Operations and
|Nine months ended
|Three months ended
|(In thousands, except share and per-share amounts)||2019||2018||2019||2018|
|Research and development||47,873||32,143||16,241||12,733|
|General and administrative||14,125||8,469||4,810||3,680|
|Total operating expenses||61,998||40,612||21,051||16,413|
|Loss from operations||(61,998||)||(40,612||)||(21,051||)||(16,413||)|
|Other income (expense):|
|Total other income (expense), net||656||631||(98||)||475|
|Net loss attributable to common stockholders||(61,342||)||(39,981||)||(21,149||)||(15,938||)|
|Other comprehensive gain (loss)|
|Unrealized gain (loss) on marketable securities||1||—||(10||)||—|
|Total other comprehensive gain (loss)||1||—||(10||)||—|
|Net loss per share attributable to common stockholders,
basic and diluted
|Weighted average common shares outstanding, basic
|Constellation Pharmaceuticals, Inc.|
|Consolidated Balance Sheets|
|(In $ thousands)||September 30,
|Cash and cash equivalents||$||78,977||$||114,592|
|Total current assets||92,210||117,303|
|Long-term debt, net of current portion and discount||29,603||—|
|Total stockholders’ equity||$||48,152||$||104,158|
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, the Company’s plans, strategies and prospects for its business. All statements, other than statements of historical facts, contained in this press release, including statements regarding the implications of preliminary or interim clinical data, the development status of the Company’s product candidates, and the Company’s plans for future data presentations, the Company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements 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. These risks and uncertainties include, but are not limited to, risks associated with the Company’s ability to: obtain and maintain necessary approvals from the
Senior Director, Investor Relations
MacDougall Biomedical Communications
Source: Constellation Pharmaceuticals