Constellation Pharmaceuticals Announces First-Quarter 2019 Financial Results
- Company to present an interim update of data from the MANIFEST clinical trial of CPI-0610 at
ASCOon June 3and at EHA on June 15
- Related investor event at
ASCOto be held on June 4
“2019 is a year of data for Constellation,” said
“We look forward to presenting an interim update of data from the Phase 2 MANIFEST clinical trial for CPI-0610 in a poster presentation at
“Our vision is to become a late-stage oncology development company in 2020, with an exciting pipeline of development and discovery programs that have the potential to bring important new medicines to underserved cancer patients,” Mr. Raythatha concluded.
Constellation plans to present a poster providing an interim update of data from the MANIFEST clinical trial of CPI-0610 at the
The Company will also host an analyst/investor meeting, with an accompanying conference call and webcast, to discuss the interim update of data at
- Provided data update of MANIFEST clinical trial at
J.P. Morgan Healthcare Conference. In a press release on January 3and a presentation at the J.P. Morgan Healthcare Conferenceon January 9, Constellation provided an interim update of data on the Phase 2 MANIFEST clinical trial of CPI-0610. As disclosed in that presentation, each of the first four ruxolitinib-resistant MF patients in MANIFEST remained on study as of December 10, 2018. Two patients were treated with a combination of CPI-0610 and ruxolitinib for over 16 months, and two patients were treated with CPI-0610 monotherapy for over 12 months. Each of these four patients showed a reduction in spleen volume, symptom improvement, and an increased hemoglobin level. One of the combination therapy patients, who was transfusion dependent before therapy, converted to being transfusion independent after CPI-0610 was added to the ongoing regimen. Additionally, bone marrow biopsies before and after treatment were analyzed for the two patients on monotherapy, and both demonstrated a one-grade improvement in bone marrow fibrosis score and associated improvements in hemoglobin and platelets. Taken together, these results suggest that CPI-0610 may be modifying the underlying course of the disease in these ruxolitinib-resistant MF patients.
- Presented ProSTAR results at AACR. On
April 1, Constellation presented results from the Phase 1b portion of the ProSTAR clinical trial of CPI-1205 at the American Association for Cancer Research annual meeting. These results showed clinical activity in subsets of a heterogeneous population of advanced mCRPC patients in combination with either abiraterone or enzalutamide. All PSA responses seen in the trial were ≥80%, deeper than the ≥50% reduction endpoint in the trial. The majority of patients with measurable lesions achieved durable disease control during the study. For more details, please review the poster on our website here.
The Company initiated the Phase 2 portion of the trial in late 2018 to better define the patient populations most likely to benefit from CPI-1205. The Company looks forward to reporting initial Phase 2 data in the second half of 2019.
- Expanded Board of Directors. In February, Constellation announced the appointment of Dr. Scott Braunstein to its Board of Directors. Dr. Braunstein brings a track record of growing emerging and established biopharmaceutical companies as a board member, pharmaceutical executive, and investor.
- Enhanced Management Team. Also in February, Constellation announced the appointment of
Jessica Christoas Senior Vice President and Chief Product Development Officer. Ms. Christo has 25 years of product development experience in the biopharmaceutical industry. Most recently, she was Senior Vice President of Development Operations at Verastem Oncology, where she had broad clinical and regulatory responsibilities and contributed to the approval of COPIKTRATM.
First Quarter 2019 Financial Results
- Cash, cash equivalents, and marketable securities as of
March 31, 2019, increased 1.0% compared to December 31, 2018, to $115.8 milliondue to proceeds from a $20 millionterm loan led by Hercules Capital, which approximately offset operating expenses in the quarter.
- Research and development (R&D) expenses increased 58.8% year over year to $15.7 million in the first quarter of 2019 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 92.3% year over year to
$4.4million in the first quarter of 2019, primarily due to personnel-related and facility-related costs in connection with expanding the support functions of a multi-candidate clinical-stage company, as well as costs associated with operating as a public company.
- The net loss attributable to common stockholders increased 60.5% year over year to $19.4 million mainly due to increases in G&A and R&D expenses. The net loss per share attributable to common stockholders decreased 94.0% to $0.75 per share for the first quarter of 2019 due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
The Company expects that cash, cash equivalents, and marketable securities as of March 31, 2019, will fund operating expenses and capital expenditure requirements into the third quarter of 2020.
The Company anticipates achieving the following milestones during 2019:
First Half 2019
- Provide an interim update of data from the MANIFEST Phase 2 trial of CPI-0610 at
- Complete an investigational new drug (IND) filing for CPI-0209
Second Half 2019
- Provide an interim update of data from the Phase 2 portion of the ProSTAR trial for CPI-1205
- Provide an additional data update from the MANIFEST trial for CPI-0610
|Financial Results (Unaudited)|
|Constellation Pharmaceuticals, Inc.|
|Consolidated Statements of Operations and
|Three months ended
|(In thousands, except share and per-share amounts)||2019||2018|
|Research and development||15,677||9,874|
|General and administrative||4,429||2,303|
|Total operating expenses||20,106||12,177|
|Loss from operations||(20,106||)||(12,177||)|
|Other income (expense):|
|Total other income (expense), net||680||75|
|Net loss attributable to common stockholders||(19,426||)||(12,102||)|
|Other comprehensive gain:|
|Unrealized gain on marketable securities||9||—|
|Other comprehensive gain||9||—|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.75||)||$||(12.44||)|
|Weighted average common shares outstanding, basic and diluted||25,804,595||972,981|
|Constellation Pharmaceuticals, Inc.|
|Consolidated Balance Sheets|
|(In $ thousands)||March 31,
|Cash and cash equivalents||$||52,447||$||114,592|
|Other current assets||2,695||2,711|
|Total stockholders’ equity||$||86,075||$||104,158|
Note: Abbreviated financial statements; please refer to Form 10-Q for the first quarter of 2019 for more details, including explanatory notes.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the implications of preliminary clinical data, the development status of the Company’s product candidates, the Company’s plans for future data presentations, its anticipated achievement of milestones, and its financial guidance regarding the period in which it will have capital available to fund its operations. All statements, other than statements of historical facts, contained in this press release, including statements regarding 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 Constellation’s ability to: obtain and maintain necessary approvals from the
Senior Director, Investor Relations
MacDougall Biomedical Communications
Source: Constellation Pharmaceuticals