Constellation Pharmaceuticals Announces Fourth-Quarter and Full-Year 2019 Financial Results
- Clinical data presented at 2019
American Society of Hematology(ASH) annual meeting suggested that CPI-0610 could offer meaningful benefits beyond standard of care in myelofibrosis
- In addition to previously expanded MANIFEST Cohorts 3 and 2A, now expanding Cohort 1A
- Planning update for MANIFEST and discussions with regulatory agencies about CPI-0610 around mid-year, additional MANIFEST update before yearend
- Conference call to discuss Constellation’s clinical programs and financial results scheduled for
5:00 PM EDTtoday
“The fourth quarter of 2019 was transformational for Constellation,” said
“We are targeting CPI-0610 in combination with ruxolitinib to become the standard of care in first-line treatment of myelofibrosis,”
“We look forward to discussions on CPI-0610 with regulatory agencies in the coming year. These discussions will help refine our plans for a potential registration path for CPI-0610, including our plan to initiate a global randomized Phase 3 clinical trial of CPI-0610 + ruxolitinib in JAK-inhibitor-naïve MF patients in the third quarter of 2020.
“We are also working to create value for patients in other ways,”
- Submitted abstracts for the
European Hematology Association(EHA) annual meeting in June 2020
- Expect to present 24-week data on 25-30 first-line (1L) and 70-80 second-line (2L) patients at EHA
- Continuing enrollment in previously expanded Arm 3 (1L combo patients) and Cohort 2A (2L combo transfusion-dependent patients)
- Expanding Cohort 1A (2L monotherapy transfusion-dependent patients) from 16 to up to 60 patients based on conversions of transfusion-dependent patients to transfusion independence
- Received orphan drug designation for CPI-0610 from the FDA and EMA
- Completed Phase 2 enrollment in our
- Planning for data cut and analysis in mid-2020, with a clear signal required to move program into Phase 3
- Ongoing Phase 1 dose escalation phase of Phase 1/2 clinical trial studying CPI-0209 monotherapy in advanced, relapsed solid tumor patients
- Aim to determine recommended Phase 2 dose (RP2D) for monotherapy in second half of 2020
- After determining RP2D, intend to initiate Phase 2 expansion arms for monotherapy in selected solid tumor indications as well as dose escalation studies of combinations with other therapies
- Employing biomarker strategy that includes assessment of ARID1A mutations
The Company anticipates achieving the following milestones during 2020:
CPI-0610 – Provide MANIFEST program update at EHA in June
CPI-0610 – Initiate Phase 3 clinical trial in the third quarter
CPI-0610 – Provide additional MANIFEST program update by yearend
CPI-1205 – Provide ProSTAR program update mid-year
CPI-0209 – Provide program update, including recommended Phase 2 dose, by end of year
Fourth Quarter 2019 Financial Results
- Cash, cash equivalents, and marketable securities as of December 31, 2019, were
$383.9 million, an increase of 235.0% compared to December 31, 2018, primarily due to proceeds from the private placement in October 2019and the public offering in December 2019, offset by operating expenses.
- Research and development (R&D) expenses increased 11.8% year over year to $18.6 million in the fourth quarter of 2019 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 36.6% year over year to
$5.5million in the fourth quarter of 2019, primarily due to building out the organization of the company.
- The net loss attributed to common shareholders increased 21.4% year over year to $24.2 million for the fourth quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 10.4% to
$0.69per share due to an increase in weighted average shares outstanding as a result of the private placement in October 2019and the public offering in December 2019, offset in part by the increased net loss.
Full Year 2019 Financial Results
- Research and development (R&D) expenses increased 36.3% year over year to $66.5 million in full-year 2019, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 57.1% year over year to
$19.6million in full-year 2019, primarily due to building out the organization of the company.
- The net loss attributed to common shareholders increased 42.8% year over year to $85.6 million for full-year 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 39.2% to $3.04 per share largely due to an increase in weighted average shares outstanding as a result of the initial public offering and related conversion of preferred stock to common stock in
July 2018and the additional shares issued in 2019.
Constellation expects that its current cash, cash equivalents, and marketable securities will enable it to fund operations into the second half of 2022.
Results of Operations
||Three months ended
|(In thousands, except share and per-share amounts)||2019||2018||2019||2018|
|Research and development||$||66,459||$||48,769||$||18,586||$||16,626|
|General and administrative||19,596||12,475||5,471||4,006|
|Total operating expenses||86,055||61,244||24,057||20,632|
|Loss from operations||(86,055||)||(61,244||)||(24,057||)||(20,632||)|
|Other income (expense):|
|Total other income (expense), net||529||1,319||(127||)||688|
|Loss before income taxes||(85,526||)||(59,925||)||(24,184||)||(19,944||)|
|Income tax expense||24||—||24||—|
|Other comprehensive loss|
|Unrealized loss on marketable securities||(6||)||—||(7||)||—|
|Total other comprehensive loss||(6||)||—||(7||)||—|
|Net loss attributable to common stockholders||$||(85,556||)||$||(59,925||)||$||(24,215||)||$||(19,944||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(3.04||)||$||(5.00||)||$||(0.69||)||$||(0.77||)|
|Weighted average common shares outstanding, basic and diluted||28,151,763||11,984,293||35,086,817||25,789,305|
Consolidated Balance Sheets
|(In $ thousands)||2019||2018|
|Cash and cash equivalents||$||334,332||$||114,592|
|Total current assets||386,989||117,303|
|Long-term debt, net of current portion and discount||29,642||—|
|Total stockholders’ equity||$||337,584||$||104,158|
Constellation will host a conference call at
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 and statements regarding the development status of the Company’s product candidates, the timing of availability of clinical trial data and the Company’s ability to fund its operations until the second half of 2022. 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 FDA and other regulatory authorities; continue to advance its product candidates in clinical trials; whether preliminary or interim data from a clinical trial will be predictive of the final results of the trial; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of CPI-0610, CPI-1205 and CPI-0209; advance the development of its product candidates under the timelines it anticipates, or at all, in current and future clinical trials; obtain, maintain, or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. CPI-0610, CPI-1205 and CPI-0209 are investigational therapies and have not been approved by the FDA (or any other regulatory authority). For a discussion of other risks and uncertainties, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the
Senior Director, Investor Relations
Source: Constellation Pharmaceuticals