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Verastem Oncology Reports Second Quarter 2020 Financial Results and Highlights Recent Company Progress
Announced Path Forward for VS-6766 and Defactinib Combination Following Meeting with FDA
Phase 2 Registration-Directed Trials Expected to Commence by Year End 2020 in Both Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell
Company Monetizes COPIKTRA® (duvelisib) Providing Cash Runway Until at Least 2024
“The first half of 2020 has been a time of transformational change at Verastem Oncology. We recently announced our newest strategic transaction, the sale of COPIKTRA to Secura Bio, which allows us to monetize this asset while focusing our resources and efforts on advancing the VS-6766 and defactinib combination program in KRAS mutant solid tumors,” commented
Second Quarter 2020 and Recent Highlights
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Announced Path Forward for VS-6766/Defactinib Combination in LGSOC Following Meeting with
U.S. FDA.Verastem announced today that the company met with the FDA inJuly 2020 to discuss the registration-directed study design for the VS-6766/defactinib combination in patients with LGSOC. The FDA was supportive of the Company’s development strategy and adaptive design for LGSOC. Verastem’s NSCLC study will also be an adaptive design with a focus on patients with KRAS-G12V mutant tumors.Verastem intends to seek input from the FDA after completing the initial cohort of the lung cancer study.Verastem expects to commence registration-directed clinical trials for potential accelerated approval in LGSOC and KRAS mutant NSCLC by the end of 2020. -
Selling COPIKTRA Franchise to Secura Bio in a Deal Totaling
$311 Million , Plus Royalties.Verastem recently announced its entry into a definitive agreement to sell its global commercial and development rights to COPIKTRA in all oncology indications toSecura Bio, Inc. The transaction, which carries a total deal value of up to$311 million , plus royalties, will provide Verastem’s current programs with a cash runway until at least 2024 and will allow the Company to focus its resources and efforts on the clinical development of VS-6766, its RAF/MEK inhibitor, and defactinib, its FAK inhibitor, in KRAS mutant solid tumors.Verastem is pursuing development of this combination in LGSOC and KRAS mutant NSCLC. -
Presented Preliminary Results from Investigator-initiated Phase 1 FRAME Study Evaluating the Combination of VS-6766 and Defactinib in KRAS Mutant Solid Tumors at AACR 2020 Virtual Meeting I. In a virtual poster presentation,
Udai Banerji , MBBS, MD, DNB, PhD, FRCP, NIHR, Professor of Molecular Cancer Pharmacology atThe Institute of Cancer Research and Honorary Consultant in Medical Oncology atThe Royal Marsden NHS Foundation Trust , highlighted data from this ongoing, open-label, dose-escalation and expansion study in patients with KRAS mutant advanced solid tumors, including LGSOC and NSCLC. Preliminary data demonstrated a 67% overall response rate and long duration of therapy among patients with LGSOC. Based on higher response rates seen in NSCLC patients with KRAS-G12V mutations,Verastem will also be further exploring the role of the VS-6766/defactinib combination in KRAS-G12V NSCLC. Expansion cohorts remain ongoing in LGSOC and NSCLC and the study will be expanding to include new cohorts in pancreatic, KRAS mutant endometrial and KRAS-G12V NSCLC. -
Presented New Preclinical VS-6766/Defactinib Combination Data in Uveal Melanoma at AACR 2020 Virtual Meeting II. In this study, researchers identified and reinforced that FAK inhibition is a viable pathway to inhibit downstream from the GNAQ pathway, which is constitutively active in uveal melanoma. It was observed that co-targeting FAK and RAF/MEK signaling led to tumor collapse in uveal melanoma xenograft and liver metastasis models in vivo. Based on these encouraging results,
Verastem plans to support an investigator-sponsored, Phase 2 clinical testing of the VS-6766/defactinib combination in uveal melanoma, which is expected to commence by the end of 2020. -
Appointed
John H. Johnson to the Board of Directors. In April, Verastem Oncology announced the appointment ofJohn H. Johnson to its Board of Directors. Mr. Johnson’s career spans multiple executive management roles at leading global corporations where he was responsible for overseeing oncology and immunology drug development initiatives and commercialization.Mr. Johnson will serve on the Compensation and Nominating and Governance Committees.
Upcoming Milestones
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Close transaction with Secura Bio during the third quarter of 2020.
-
Present updated data from the LGSOC cohort of the investigator-initiated Phase 1/2 FRAME study evaluating VS-6766 and defactinib in KRAS mutant solid tumors in September, including at the 2nd Annual
RAS-Targeted Drug Development Conference onSeptember 16, 2020 . -
Present new preclinical data from studies investigating VS-6766 and defactinib in combination with KRAS-G12C inhibitors in September, including at the 2nd Annual
RAS-Targeted Drug Development Conference onSeptember 16, 2020 . -
Commence registration-directed clinical trials in LGSOC and KRAS mutant NSCLC by the end of 2020.
-
Submit updated data from the NSCLC cohort of the investigator-initiated Phase 1/2 FRAME study to the International Association for the Study of
Lung Cancer (IASLC) World Lung Cancer Conference, taking place inJanuary 2021 .
Second Quarter 2020 Financial Results
Net product revenue for the three months ending
Total operating expenses for the 2020 Quarter were
Research and development (R&D) expense for the 2020 Quarter was
Selling, general and administrative (SG&A) expense for the 2020 Quarter was
Net loss for the 2020 Quarter was
For the 2020 Quarter, non-GAAP adjusted net loss was
Verastem Oncology ended the second quarter of 2020 with cash, cash equivalents and short-term investments of
Financial Guidance and Outlook
With the proceeds from the sale of COPIKTRA,
Use of Non-GAAP Financial Measures
To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in
About VS-6766
VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.
About Defactinib
Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and
About the VS-6766/Defactinib Combination
RAS mutant tumors are present in 30% of all human cancers and have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.
The combination of VS-6766 and defactinib has been found to be clinically active in KRAS mutant tumors. In an ongoing investigator-initiated Phase I/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mutant NSCLC and colorectal cancer (CRC). Preliminary data from this study presented at the
About COPIKTRA® (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.iii,iv,v COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status and Orphan Drug Designation, and is being investigated in combination with other agents through investigator-sponsored studies.vi For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Verastem Oncology
Our first FDA approved product is available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL).
For more information, please visit www.verastem.com.
Forward-Looking Statements Notice
This press release includes forward-looking statements about Verastem Oncology’s strategy, future plans and prospects, including statements related to the expected sale of COPIKTRA, the Company’s future funding requirements and the potential clinical value of the RAF/MEK/FAK combination. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," “can,” “promising” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks and uncertainties, among other things, regarding: the satisfaction of closing conditions with respect to the sale of the COPIKTRA assets to Secura Bio; the ability of Secura Bio to achieve the clinical and sales milestones necessary to result in additional consideration payable to
Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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(unaudited) |
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|
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2020 |
|
2019 |
|
||
|
|
|
|
|
|
|
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Cash, cash equivalents, & investments |
|
$ |
125,328 |
|
$ |
75,506 |
|
Accounts receivable, net |
|
|
1,500 |
|
|
2,524 |
|
Inventory |
|
|
6,316 |
|
|
3,096 |
|
Restricted cash, Prepaid expenses and other current assets |
|
|
11,448 |
|
|
3,835 |
|
Property and equipment, net |
|
|
791 |
|
|
947 |
|
Intangible assets, net |
|
|
19,223 |
|
|
20,008 |
|
Right-of-use asset, net |
|
|
2,909 |
|
|
3,077 |
|
Restricted cash and other assets |
|
|
31,017 |
|
|
36,053 |
|
Total assets |
|
$ |
198,532 |
|
$ |
145,046 |
|
|
|
|
|
|
|
|
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Current Liabilities |
|
$ |
28,784 |
|
$ |
29,890 |
|
Long-term debt |
|
|
30,899 |
|
|
35,067 |
|
Convertible senior notes |
|
|
20,381 |
|
|
68,556 |
|
Lease Liability, long-term |
|
|
3,225 |
|
|
3,489 |
|
Other liabilities |
|
|
870 |
|
|
870 |
|
Stockholders’ equity |
|
|
114,373 |
|
|
7,174 |
|
Total liabilities and stockholders’ equity |
|
$ |
198,532 |
|
$ |
145,046 |
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Condensed Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three months ended |
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Six months ended |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenue: |
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Product revenue, net |
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$ |
4,235 |
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$ |
3,019 |
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$ |
9,269 |
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$ |
4,690 |
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License and collaboration revenue |
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|
72 |
|
|
117 |
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|
94 |
|
|
117 |
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Total revenue |
|
|
4,307 |
|
|
3,136 |
|
|
9,363 |
|
|
4,807 |
|
Operating expenses: |
|
|
|
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|
|
|
|
|
|
|
|
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Cost of sales - product |
|
|
392 |
|
|
377 |
|
|
887 |
|
|
534 |
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Cost of sales - intangible amortization |
|
|
393 |
|
|
392 |
|
|
785 |
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|
785 |
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Research and development |
|
|
9,344 |
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|
11,346 |
|
|
20,268 |
|
|
21,103 |
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Selling, general and administrative |
|
|
15,442 |
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|
29,298 |
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|
35,046 |
|
|
55,331 |
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Total operating expenses |
|
|
25,571 |
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|
41,413 |
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|
56,986 |
|
|
77,753 |
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Loss from operations |
|
|
(21,264) |
|
|
(38,277) |
|
|
(47,623) |
|
|
(72,946) |
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Other expense |
|
|
— |
|
|
— |
|
|
(1,313) |
|
|
— |
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Interest income |
|
|
122 |
|
|
1,268 |
|
|
478 |
|
|
2,765 |
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Interest expense |
|
|
(1,868) |
|
|
(5,185) |
|
|
(12,542) |
|
|
(10,115) |
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Net Loss |
|
$ |
(23,010) |
|
$ |
(42,194) |
|
$ |
(61,000) |
|
$ |
(80,296) |
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Net loss per share—basic and diluted |
|
$ |
(0.14) |
|
$ |
(0.57) |
|
$ |
(0.45) |
|
$ |
(1.09) |
|
Weighted average common shares outstanding used in computing net loss per share—basic and diluted |
|
|
165,395 |
|
|
73,877 |
|
|
136,775 |
|
|
73,865 |
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|
|
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Reconciliation of GAAP to Non-GAAP Financial Information |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three months ended |
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Six months ended |
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2020 |
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2019 |
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2020 |
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2019 |
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Net Loss Reconciliation |
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Net Loss (GAAP basis) |
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$ |
(23,010) |
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$ |
(42,194) |
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$ |
(61,000) |
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$ |
(80,296) |
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Adjust: |
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|
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Amortization of acquired intangible asset |
|
|
393 |
|
|
392 |
|
|
785 |
|
|
785 |
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Stock-based compensation expense |
|
|
1,659 |
|
|
3,065 |
|
|
3,029 |
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|
5,313 |
|||||||
Non-cash interest, net |
|
|
480 |
|
|
1,207 |
|
|
9,259 |
|
|
2,815 |
|||||||
Severance and Other |
|
|
11 |
|
|
1,957 |
|
|
1,798 |
|
|
1,994 |
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Change in fair value of derivative |
|
|
— |
|
|
— |
|
|
1,313 |
|
|
— |
|||||||
Chugai license payment |
|
|
— |
|
|
— |
|
|
3,000 |
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|
— |
|||||||
Adjusted Net Loss (non-GAAP basis) |
|
$ |
(20,467) |
|
$ |
(35,573) |
|
$ |
(41,816) |
|
$ |
(69,389) |
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Reconciliation of Net Loss Per Share |
|
|
|
|
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|
|
|
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|||||||
Net Loss per share – diluted (GAAP Basis) |
|
|
(0.14) |
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(0.57) |
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(0.45) |
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(1.09) |
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Adjust per diluted share |
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Amortization of acquired intangible asset |
|
|
— |
|
|
— |
|
|
0.01 |
|
|
0.01 |
|||||||
Stock-based compensation expense |
|
|
0.01 |
|
|
0.04 |
|
|
0.02 |
|
|
0.07 |
|||||||
Non-cash interest, net |
|
|
0.01 |
|
|
0.02 |
|
|
0.07 |
|
|
0.04 |
|||||||
Severance and Other |
|
|
— |
|
|
0.03 |
|
|
0.01 |
|
|
0.03 |
|||||||
Change in fair value of derivative |
|
|
— |
|
|
— |
|
|
0.01 |
|
|
— |
|||||||
Chugai license payment |
|
|
— |
|
|
— |
|
|
0.02 |
|
|
— |
|||||||
Adjusted Net Loss per share – diluted (non-GAAP Basis) |
|
$ |
(0.12) |
|
$ |
(0.48) |
|
$ |
(0.31) |
|
$ |
(0.94) |
|||||||
Weighted average common shares outstanding used in computing net loss per share—diluted |
|
|
165,395 |
|
|
73,877 |
|
|
136,775 |
|
|
73,865 |
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i Gerber D. et al. Phase 2 study of the focal adhesion kinase inhibitor defactinib (VS-6063) in previously treated advanced KRAS mutant non-small cell lung cancer.
ii Chénard-Poirier, M. et al. Results from the biomarker-driven basket trial of RO5126766 (CH5127566), a potent RAF/MEK inhibitor, in RAS- or RAF-mutated malignancies including multiple myeloma.
iii Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models.
iv Reif K et al. Cutting Edge: Differential Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
v Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.
vi www.clinicaltrials.gov, NCT03372057.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200810005166/en/
Verastem Oncology Contacts:
Investors:
Vice President, Investor Relations & Finance
+1 781-469-1546
jdoyle@verastem.com
+1 212 600 1902
joseph@argotpartners.com
Media:
Corporate Communications
+1 781-292-4205
lbuffington@verastem.com
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