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Constellation Pharmaceuticals Announces Third-Quarter 2020 Financial Results

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  • MANIFEST data update planned for the American Society of Hematology (ASH) meeting in December

CAMBRIDGE, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced its third-quarter 2020 financial results. The Company also provided updates on its product candidates CPI-0610 and CPI-0209.

“Many myelofibrosis patients continue to have significant unmet needs despite available therapy,” said Jeff Humphrey, M.D., Chief Medical Officer of Constellation Pharmaceuticals. “Constellation and leading clinical investigators are eager to enroll patients in MANIFEST-2, our pivotal Phase 3 study, to potentially define a new standard of care for MF patients.”

“We look forward to providing an update of MANIFEST data for CPI-0610 at the upcoming ASH conference,” said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. “We believe that CPI-0610 has the potential to modify the course of myelofibrosis by providing benefits across all four hallmarks of the disease: spleen volume reduction, symptom improvement, hemoglobin increases, and bone marrow fibrosis improvement.”

CPI-0610

  • Constellation plans to provide its next MANIFEST data update at the American Society of Hematology (ASH) in December 2020, including 24-week data for SVR35 (≥35% spleen volume reduction) and TSS50 (50% improvement in Total Symptom Score) from 50-60 first-line and 90-100 second-line myelofibrosis patients.

  • Two oral presentations will focus on clinical data from JAK-inhibitor-naïve MF patients (Arm 3) and JAK-inhibitor-experienced MF patients being treated with CPI-0610 as an add-on to ruxolitinib (Arm 2).

  • Three poster presentations will focus on translational data, clinical data from second-line patients being treated with CPI-0610 monotherapy (Arm 1), and the Phase 3 MANIFEST-2 trial in progress.

  • The Company will also hold an investor event on December 7, 2020, to discuss these data. Event details will be provided later.

  • Abstracts to be published on November 5, 2020, will be based on the April 17, 2020, data cutoff also used for the Company’s presentation at the European Hematology Association meeting in June 2020. Updated data will be presented at the ASH meeting.

  • Patient enrollment in Arm 3 of MANIFEST, the Phase 2 clinical trial for CPI-0610, has been completed at approximately 80 JAK-inhibitor-naïve MF patients.

  • MANIFEST-2, the pivotal Phase 3 trial for CPI-0610, remains on track to begin patient enrollment in the fourth quarter of 2020.

ASH Oral Presentations

Title: CPI-0610, a Bromodomain and Extraterminal Domain Protein (BET) Inhibitor, in Combination with Ruxolitinib, in JAK-Inhibitor-Naïve Myelofibrosis Patients: Update of MANIFEST Phase 2 Study
Oral Session: 634. Myeloproliferative Syndromes: Clinical: New Therapies and JAKi-based Combinations for Myelofibrosis
Date and Time: December 5, 2020, 11:30 AM EST
Presenter: Dr. John Mascarenhas, Associate Professor of the Icahn School of Medicine at Mount Sinai

Title: CPI-0610, Bromodomain and Extraterminal Domain Protein (BET) Inhibitor, As “Add-on” to Ruxolitinib, in Advanced Myelofibrosis Patients with Suboptimal Response: Update of MANIFEST Phase 2 Study
Oral Session: 634. Myeloproliferative Syndromes: Clinical: New Therapies and JAKi-based Combinations for Myelofibrosis
Date and Time: December 5, 2020, 11:45 AM EST
Presenter: Dr. Srdan Verstovsek, Medical Oncologist, MD Anderson Cancer Center

ASH Poster Presentations

Title: CPI-0610, a Bromodomain and Extraterminal Domain Protein (BET) Inhibitor, As Monotherapy in Advanced Myelofibrosis Patients Refractory / Intolerant to JAK Inhibitor: Update from Phase 2 MANIFEST Study
Session: 634. Myeloproliferative Syndromes: Clinical: Poster II
Date and Time: Sunday, December 6, 2020, 10:00 AM-6:30 PM EST
Presenter: Dr. Moshe Talpaz, Professor of Leukemia Research and Professor of Internal Medicine, University of Michigan Medical School

Title: MANIFEST-2, a Global, Phase 3, Randomized, Double-Blind, Active-Control Study of CPI-610 and Ruxolitinib Vs. Placebo and Ruxolitinib in JAK-Inhibitor-Naïve Myelofibrosis Patients
Session: 634. Myeloproliferative Syndromes: Clinical: Poster III
Date and Time: Monday, December 7, 2020, 10:00 AM-6:30 PM EST
Presenter: Dr. John Mascarenhas, Associate Professor of the Icahn School of Medicine at Mount Sinai

Title: The BET Inhibitor, CPI-0610, Promotes Myeloid Differentiation in Myelofibrosis Patient Bone Marrow and Peripheral CD34+ Hematopoietic Stem Cells
Session: 634. Myeloproliferative Syndromes: Clinical: Poster III
Date and Time: Monday, December 7, 2020, 10:00 AM-6:30 PM EST
Presenter: Dr. Mohamed Salama, Professor of Pathology and Laboratory Medicine, Mayo Clinic School of Medicine

CPI-0209

  • The Phase 1 dose escalation portion of a Phase 1/2 clinical trial of the EZH2 inhibitor CPI-0209 is progressing well. Patient dosing has advanced through multiple dosing cohorts as planned.

  • Data from the Phase 1 portion will guide our recommended Phase 2 dose selection for monotherapy and combination expansion arms in select tumor types.

  • Clinical data will be supplemented with data on biomarkers to identify patients most likely to benefit.

Third Quarter 2020 Financial Results

  • Cash, cash equivalents, and marketable securities as of September 30, 2020, were $489.4 million.

  • Research and development (R&D) expenses increased 56.7% year over year to $25.4 million in the third quarter of 2020, mainly due to increased clinical trial expenses.

  • General and administrative (G&A) expenses grew 65.0% year over year to $7.9 million in the third quarter of 2020, primarily due to building out the organization of the company.

  • The net loss attributed to common shareholders increased 59.7% year over year to $33.8 million for the third quarter of 2020, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 13.4% to $0.71 per share due to an increase in shares outstanding as a result of the private placement in October 2019 and the public offerings in December 2019 and June 2020, offset in part by the increased net loss.

Nine Month 2020 Financial Results

  • Research and development (R&D) expenses increased 42.3% year over year to $68.1 million in the first nine months of 2020, mainly due to increased clinical trial expenses.

  • General and administrative (G&A) expenses grew 47.3% year over year to $20.8 million in the first nine months of 2020, primarily due to building out the organization of the company.

  • The net loss attributed to common shareholders increased 45.0% year over year to $89.0 million for the first nine months of 2020, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 15.1% to $2.02 per share due to an increase in shares outstanding as a result of the private placement in October 2019 and the public offerings in December 2019 and June 2020, offset in part by the increased net loss.

Financial Guidance

Constellation expects that its current cash, cash equivalents, and marketable securities will fund operations into mid-2023.

Results of Operations (unaudited)

Nine months ended
September 30,

Three months ended
September 30,

(In thousands, except share and per-share amounts)

2020

2019

2020

2019

Operating expenses:

Research and development

$

68,145

$

47,873

$

25,443

$

16,241

General and administrative

20,803

14,125

7,935

4,810

Total operating expenses

88,948

61,998

33,378

21,051

Loss from operations

(88,948

)

(61,998

)

(33,378

)

(21,051

)

Other income (expense):

Interest income

2,549

1,914

459

507

Gain on disposal of equipment

29

Interest expense

(2,564

)

(1,258

)

(857

)

(605

)

Total other income (expense), net

14

656

(398

)

(98

)

Loss before income taxes

(88,934

)

(61,342

)

(33,776

)

(21,149

)

Income tax expense

39

Net loss

$

(88,973

)

$

(61,342

)

$

(33,776

)

$

(21,149

)

Net loss per share attributable to common stockholders, basic and diluted

$

(2.02

)

$

(2.38

)

$

(0.71

)

$

(0.82

)

Weighted average number of common shares used in net loss per share attributable to common stockholders, basic and diluted

43,976,371

25,814,593

47,534,964

25,829,105

Comprehensive loss:

Net loss

$

(88,973

)

$

(61,342

)

$

(33,776

)

$

(21,149

)

Other comprehensive gain (loss):

Unrealized gain (loss) on marketable securities

140

1

(121

)

(10

)

Total other comprehensive gain (loss)

$

140

$

1

$

(121

)

$

(10

)

Comprehensive loss

$

(88,833

)

$

(61,341

)

$

(33,897

)

$

(21,159

)

Consolidated Balance Sheets (unaudited)

September 30,

December 31,

(In $ thousands)

2020

2019

Cash and cash equivalents

$

116,996

$

334,332

Marketable securities

372,358

49,602

Total current assets

494,466

386,989

Total assets

505,449

399,130

Current liabilities

31,274

22,755

Long-term debt, net of current portion and discount

24,088

29,642

Total liabilities

62,679

61,546

Total stockholders’ equity

$

442,770

$

337,584

Conference Call

Constellation will host a conference call at 8:00 AM EDT on October 29, 2020, to discuss its clinical programs and financial results. The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at http://ir.constellationpharma.com/events-and-presentations/events. To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 7374769.

About MANIFEST

MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating CPI-0610 in combination with ruxolitinib in JAK-inhibitor-naïve MF patients (Arm 3), with a primary endpoint of the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. Constellation is also evaluating CPI-0610, either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1), or as add-on therapy in combination with ruxolitinib in patients with a sub-optimal response to ruxolitinib or MF progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on TD status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to TI for 12 consecutive weeks. The primary endpoint for the patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a ≥35% spleen volume reduction from baseline after 24 weeks of treatment.

About MANIFEST-2

MANIFEST-2 is a global, blinded, randomized, Phase 3 clinical study with CPI-0610 in combination with ruxolitinib versus placebo plus ruxolitinib in JAK-inhibitor-naïve patients with primary myelofibrosis or post-ET or post-PV myelofibrosis, who have splenomegaly and symptoms requiring therapy. It is designed to enroll approximately 310 patients, randomized 1:1 to the CPI-0610 + ruxolitinib arm or the placebo + ruxolitinib arm. The primary endpoint of the study is a ≥35% reduction in spleen volume (SVR35) from baseline at 24 weeks. A key secondary endpoint of the study is 50% or greater improvement in Total Symptom Score (TSS50) from baseline at 24 weeks. Other endpoints include bone marrow fibrosis grade improvements, duration of transfusion independence, rate of red-blood-cell transfusion for the first 24 weeks, and hemoglobin response.

About Constellation Pharmaceuticals

Constellation Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics that selectively modulate gene expression to address serious unmet medical needs in patients with cancer. The Company has a deep understanding of how epigenetic and chromatin modifications in cancer cells and in the tumor and immune microenvironment play a fundamental role in driving disease progression and drug resistance. Constellation is driving development of the BET inhibitor CPI-0610 for the treatment of myelofibrosis as well as the EZH2 inhibitor CPI-0209 for the treatment of solid tumors. The Company is also applying its broad research and development capabilities to explore other novel targets that directly and indirectly impact gene expression to fuel a sustainable pipeline of innovative small-molecule product candidates.

Forward-Looking Statements

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 Company’s clinical development and regulatory plans, timelines, and prospects, the timing of availability of clinical trial data and the Company’s ability to fund its operations thru mi-2023. 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 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; raise the substantial additional capital needed to achieve its business objectives; the COVID-19 pandemic and general economic and market conditions. 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 Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Contacts

Kia Khaleghpour, Ph.D.
Vice President, Investor Relations and Communications
Constellation Pharmaceuticals
+1 617-844-6859
kia.khaleghpour@constellationpharma.com

Ronald Aldridge
Senior Director, Investor Relations
Constellation Pharmaceuticals
+1 617-714-0539
ron.aldridge@constellationpharma.com

Lauren Arnold
Media Relations
MacDougall Biomedical Communications
+1 781-235-3060
larnold@macbiocom.com