On February 23, 2017 Incyte Corporation (Nasdaq:INCY) reported a multi-year research collaboration with the Abramson Cancer Center at the University of Pennsylvania (Press release, Incyte, FEB 23, 2017, View Source [SID1234517809]). Through this collaboration, Incyte and Abramson have agreed to bring together the knowledge and expertise of their leading drug discovery and development scientists to conduct collaborative research aimed at advancing the understanding of cancer biology and fostering innovative science in immunotherapy. Schedule your 30 min Free 1stOncology Demo! Under the collaboration, Penn investigators will leverage their expertise in preclinical biology and translational science to investigate the novel therapeutics being discovered at Incyte and better understand their mechanisms of action—further developing the clinical rationales for combination therapy and patient selection. Additionally, in a combined effort to better define the relationships between human tumor characteristics and immune cell infiltration and function, Incyte and Penn will work together to develop a bioinformatics program in clinical immunotherapy aimed at fostering the advancement of novel therapeutics.
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During the period of the collaboration, Incyte will provide financial support for these research programs and may also conduct additional grant-funded research with Penn investigators in other innovative areas of cancer immunology.
"Incyte and Abramson are mutually committed to the advancement of science and improving the lives of patients with cancer. This alliance will allow us to mobilize two groups of leading scientists toward the collective goal of advancing the field of immunotherapy," said Reid Huber, Ph.D., Chief Scientific Officer at Incyte. "We are excited for the opportunity to partner with the world-class researchers at Abramson and investigate new avenues for the treatment of patients with cancer."
Month: February 2017
Emergent BioSolutions Reports Fourth Quarter and Twelve Months 2016 Financial Results; Reaffirms 2017 Guidance and Provides 2020 Goals
On February 23, 2017 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and twelve months ended December 31, 2016 (Press release, Emergent BioSolutions, FEB 23, 2017, View Source [SID1234517807]). Schedule your 30 min Free 1stOncology Demo! 2016 FINANCIAL HIGHLIGHTS (1) (2)
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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(in millions) 4Q 2016 CY 2016
Combined & Continuing
Operations Basis Combined
Basis Continuing Operations
Basis
Total Revenues $ 151.7 $ 510.2 $ 488.8
Net Income $ 32.3 $ 51.8 $ 62.5
Adjusted Net Income (3) $ 36.6 $ 73.1 $ 77.5
EBITDA (3) $ 61.3 $ 111.5 $ 141.7
(1) The presentation of Emergent’s financial performance using the "Combined Basis" method includes the impact of the operations associated with the Company’s former biosciences business which was spun-off into a separate publicly traded company, Aptevo Therapeutics Inc., on August 1, 2016. The presentation of Emergent’s financial performance using the "Continuing Operations Basis" method excludes the impact of the operations of Aptevo.
(2) See "Reconciliation of Statement of Operations" for a reconciliation of the Company’s Statement of Operations for the Three and Twelve Months Ended December 31, 2016 on a continuing operations basis to that on a combined basis.
(3) See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
2016 BUSINESS ACCOMPLISHMENTS
Signed a follow-on contract with the Centers for Disease Control and Prevention (CDC) to supply approximately 29.4 million doses of BioThrax (Anthrax Vaccine Adsorbed) to the Strategic National Stockpile (SNS) through September 2021, valued at up to $911 million
Signed a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for advanced development and procurement of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant), the Company’s next generation anthrax vaccine candidate, valued at up to $1.6 billion
Received a Sole Source Notification issued by BARDA for the procurement of approximately $100 million of BioThrax for delivery into the SNS within 24 months from the date of contract award
Achieved U.S. Food and Drug Administration (FDA) licensure for large-scale manufacturing of BioThrax in Building 55
Completed the spin-off of Aptevo Therapeutics Inc.
2016 FINANCIAL PERFORMANCE
Note: The following discussion of Emergent’s year to date and quarter ended December 31, 2016 unaudited, financial performance is on a Continuing Operations Basis.
(I) Quarter Ended December 31, 2016
Revenues
Product Sales
For Q4 2016, product sales were $87.5 million, a decrease of 30% as compared to 2015. The decrease is principally attributable to lower BioThrax deliveries under the Company’s new contract with the CDC, signed in December 2016.
(in millions) Three Months Ended
December 31,
2016 2015 % Change
Product Sales
BioThrax 43.8 $ 111.9 (61 )%
Other 43.7 $ 12.5 249 %
Total Product Sales 87.5 $ 124.4 (30 )%
Contract Manufacturing
For Q4 2016, revenue from the Company’s contract manufacturing operations was $16.7 million, an increase of 59% as compared to 2015. The increase primarily reflects an increase in fill/finish services at the Company’s Camden facility in Baltimore.
Contracts and Grants
For Q4 2016, contracts and grants revenue was $47.5 million, an increase of 91% as compared to 2015. The increase primarily reflects an increase in development funding for the Company’s Bayview facility in Baltimore designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) and plasma collection for the Company’s VIGIV [Vaccinia Immune Globulin Intravenous (Human)] program.
Operating Expenses
Cost of Product Sales and Contract Manufacturing
For Q4 2016, cost of product sales and contract manufacturing was $38.3 million, an increase of 11% as compared to 2015. The increase reflects an increase in the BioThrax cost per dose sold associated with lower production yield in the period in which the doses sold were produced, along with increased costs associated with the increase in Other product sales volume, partially offset by a decrease in BioThrax sales to the CDC.
Research and Development
For Q4 2016, gross research and development (R&D) expenses were $27.1 million, an increase of 7% as compared to 2015.
For Q4 2016, net R&D was fully funded, resulting in a net contribution from funded development programs of $20.4 million, as compared to a net expense of $0.5 million in 2015. Net R&D, which is more representative of the Company’s actual out-of-pocket investment in product development, is calculated as gross research and development expenses less contracts and grants revenue.
(in millions) Three Months Ended
December 31,
2016 2015
% Change
Research and Development Expenses [Gross] $ 27.1 $ 25.3 (7 )%
Adjustments:
– Contracts and grants revenue $ 47.5 $ 24.8 91 %
Net Research and Development Expenses (Income) $ (20.4 ) $ 0.5 –
Selling, General and Administrative
For Q4 2016, selling, general and administrative expenses were $35.4 million, an increase of 1% as compared to 2015.
Net Income
For Q4 2016, net income was $32.3 million, or $0.67 per diluted share, versus $42.5 million, or $0.90 per diluted share, in 2015.
For Q4 2016 and 2015, net income per diluted share is computed using the "if-converted" method. This method requires net income to be adjusted to add back interest expense and amortization of debt issuance cost, both net of tax, associated with the Company’s 2.875% Convertible Senior Notes due 2021. As a result, net income per diluted share for Q4 2016 is adjusted in the amount of $1.1 million, from $32.3 million to $33.4 million, and diluted shares outstanding were 49.6 million. Net income per diluted share for Q4 2015 is adjusted in the amount of $0.9 million, from $42.5 million to $43.4 million, and diluted shares outstanding were 48.1 million.
(II) Twelve Months Ended December 31, 2016
Revenues
Product Sales
For the twelve months of 2016, product sales were $296.3 million, a decrease of 10% as compared to 2015. The decrease is principally attributable to a 19% reduction in BioThrax sales, including reduced deliveries in 4Q 2016 related to the timing of signing the Company’s follow-on contract with CDC in December 2016.
(in millions) Twelve Months Ended
December 31,
2016 2015
% Change
Product Sales
BioThrax $ 237.0 $ 293.9 (19 )%
Other $ 59.3 $ 35.1 69 %
Total Product Sales $ 296.3 $ 329.0 (10 )%
Contract Manufacturing
For the twelve months of 2016, revenue from contract manufacturing operations was $49.1 million, an increase of 14% as compared to 2015. The increase reflects an increase in fill/finish services from the Company’s Camden facility and an increase in bulk manufacturing services from the Company’s facility in Winnipeg, partially offset by a decrease in contract manufacturing revenue related to the production of an MVA Ebola vaccine candidate in 2015.
Contracts and Grants
For the twelve months of 2016, contracts and grants revenue was $143.4 million, an increase of 22% as compared to 2015. The increase reflects an increase in development funding for the Company’s CIADM program, VIGIV program related to plasma collection, and the NuThrax program related to preparations for a Phase III clinical trial. These increases were offset by lower development funding for the Company’s Anthrasil [Anthrax Immune Globulin Intravenous (Human)] program related to timing of plasma collection, PreviThrax (recombinant protective antigen anthrax vaccine, purified) candidate related to reduced interest by the U.S. government to fund such a program, and Building 55 related to FDA licensure of the facility in August 2016.
Operating Expenses
Cost of Product Sales and Contract Manufacturing
For the twelve months of 2016, cost of product sales and contract manufacturing was $131.3 million, an increase of 22% as compared to 2015. The increase primarily reflects an increase in the BioThrax cost per dose sold associated with lower production yield, along with increased costs associated with the increase in Other product sales volume, partially offset by a decrease in BioThrax sales to the SNS.
Research and Development
For the twelve months of 2016, gross R&D expenses were $108.3 million, a decrease of 9% as compared to 2015. The decrease primarily reflects lower contract service costs.
For the twelve months of 2016, net R&D was fully funded, resulting in a net contribution from funded development programs of $35.1 million, as compared to a net expense of $1.8 million in 2015.
(in millions) Twelve Months Ended
December 31,
2016 2015 % Change
Research and Development Expenses [Gross] $ 108.3 $ 119.2 (9 )%
Adjustments:
– Contracts and grants revenue $ 143.4 $ 117.4 22 %
Net Research and Development Expenses (Income) $ (35.1 ) $ 1.8 –
Selling, General and Administrative
For the twelve months of 2016, selling, general and administrative expenses were $143.7 million, an increase of 19% as compared to 2015. This increase includes costs associated with restructuring activities at the Company’s Lansing, Michigan site, along with increased professional services to support the Company’s strategic growth initiatives and increased information technology investments.
Net Income
For the twelve months of 2016, net income was $62.5 million, or $1.35 per diluted share, versus $107.6 million, or $2.36 per diluted share, in 2015.
Pursuant to the "if-converted" method, net income per diluted share for the twelve months of 2016 is adjusted in the amount of $4.0 million, from $62.5 million to $66.5 million, and diluted shares outstanding were 49.1 million. Net income from continuing operations per diluted share for the twelve months of 2015 is adjusted in the amount of $3.9 million, from $107.6 million to $111.5 million, and diluted shares outstanding were 47.3 million.
2017 FORECAST & OPERATIONAL GOALS
Full Year 2017 Forecast:
Total revenue of $500 to $530 million, including BioThrax sales of $265 to $280 million
GAAP net income of $60 to $70 million
Adjusted net income of $70 to $80 million (3)
EBITDA of $135 to $145 million (3)
(3) See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
Revised 1Q 2017 Forecast:
Total revenue of $110 to $125 million
2017 Operational Goals:
Initiate three Phase I or II clinical studies for EID therapeutics
Advance NuThrax development to enable initiating a Phase III study in 2018
Initiate two human factor studies for a nerve agent antidote auto-injector
Complete an acquisition that generates revenue within 12 months of closing
2020 FINANCIAL & OPERATIONAL GOALS
The Company is targeting the following 2020 financial and operational goals:
Total Revenue: $1 billion
Revenue Mix: >10% of total revenue from ex-US customers
Expense Discipline: Net R&D <15% of net revenue (4); SG&A <25% of total revenue
Net Income: 13% of total revenue
Product Development Pipeline: Six products in clinical or advanced development (three dual market)
(4) Computed as Total Revenue less Contracts & Grants Revenue.
RECONCILIATION OF NET INCOME TO ADJUSTED NET INCOME AND EBITDA
This press release contains two financial measures (Adjusted Net Income and EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. The Company views these non-GAAP financial measures as a means to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results and comparison to competitors’ operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure, may provide a more complete understanding of factors and trends affecting the Company’s business.
The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.
(I) Reconciliation of Net Income to Adjusted Net Income
COMBINED BASIS
(in millions, except per share value) Three Months Ended December 31,
2016 2015 Source
Net Income $ 32.3 $ 33.3 NA
Adjustments:
+ Acquisition-related costs (transaction & integration) 1.0 2.0 SG&A
+ Non-cash amortization charges 1.9 2.7 COGS, SG&A,
Other Income
+ Exit and disposal costs 2.6 1.2 SG&A
+ Impact of purchase accounting on inventory step-up 1.1 – COGS
Tax effect (2.3 ) (2.1 ) NA
Total Adjustments 4.3 3.8 NA
Adjusted Net Income
Adjusted Net Income per Diluted Share $36.6
$0.74
$37.1
$0.77
NA
CONTINUING OPERATIONS BASIS
(in millions, except per share value) Three Months Ended December 31,
2016 2015 Source
Net Income $ 32.3 $ 42.5 NA
Adjustments:
+ Acquisition-related costs (transaction & integration) 1.0 0.1 SG&A
+ Non-cash amortization charges 1.9 2.2 COGS, SG&A,
Other Income
+ Exit and disposal costs 2.6 – SG&A
+ Impact of purchase accounting on inventory step-up 1.1 – COGS
Tax effect (2.3 ) (0.8 ) NA
Total Adjustments 4.3 1.5 NA
Adjusted Net Income
Adjusted Net Income per Diluted Share $36.6
$0.74
$44.0
$0.91
NA
COMBINED BASIS
(in millions, except per share value) Twelve Months Ended December 31,
2016 2015 Source
Net Income $ 51.8 $ 62.9 NA
Adjustments:
+ Spin-off and acquisition-related costs (transaction & integration) 10.4 5.5 SG&A
+ Non-cash amortization charges 9.6 10.8 COGS, SG&A,
Other Income
+ Exit and disposal costs 11.7 1.2 SG&A
+ Impact of purchase accounting on inventory step-up 1.1 0.6 COGS
Tax effect (11.5 ) (6.3 ) NA
Total Adjustments 21.3 11.8 NA
Adjusted Net Income
Adjusted Net Income per Diluted Share $73.1
$1.48
$74.7
$1.58
NA
CONTINUING OPERATIONS BASIS
(in millions, except per share value) Twelve Months Ended December 31,
2016 2015 Source
Net Income From Continuing Operations $ 62.5 $ 91.4 NA
Adjustments:
+ Acquisition-related costs (transaction & integration) 1.7 2.1 SG&A
+ Non-cash amortization charges 8.4 8.9 COGS, SG&A,
Other Income
+ Exit and disposal costs 11.7 – SG&A
+ Impact of purchase accounting on inventory step-up 1.1 0.3 COGS
Tax effect (8.0 ) (4.0 ) NA
Total Adjustments 15.0 7.4 NA
Adjusted Net Income From Continuing Operations
Adjusted Net Income per Diluted Share $77.5
$1.57
$98.8
$2.09
NA
(II) Reconciliation of Net Income to EBITDA
COMBINED BASIS
(in millions, except per share value) Three Months Ended December 31,
2016 2015
Net Income $ 32.3 $ 33.3
Adjustments:
+ Depreciation & Amortization 9.7 9.1
+ Provision For Income Taxes 16.8 14.5
+ Total Interest Expense 2.5 1.6
Total Adjustments 29.0 25.2
EBITDA
EBITDA per Diluted Share $61.3
$1.24 $58.5
$1.22
CONTINUING OPERATIONS BASIS
(in millions, except per share value) Three Months Ended December 31,
2016 2015
Net Income From Continuing Operations $ 32.3 $ 42.5
Adjustments:
+ Depreciation & Amortization 9.7 8.3
+ Provision For Income Taxes 16.8 20.7
+ Total Interest Expense 2.5 1.6
Total Adjustments 29.0 30.6
EBITDA From Continuing Operations
EBITDA per Diluted Share $61.3
$1.24 $73.1
$1.52
COMBINED BASIS
(in millions, except per share value) Twelve Months Ended December 31,
2016 2015
Net Income $ 51.8 $ 62.9
Adjustments:
+ Depreciation & Amortization 36.7 33.8
+ Provision For Income Taxes 15.4 26.9
+ Total Interest Expense 7.6 6.5
Total Adjustments 59.7 67.2
EBITDA
EBITDA per Diluted Share $111.5
$2.26 $130.1
$2.75
CONTINUING OPERATIONS BASIS
(in millions, except per share value) Twelve Months Ended December 31,
2016 2015
Net Income From Continuing Operations $ 62.5 $ 91.4
Adjustments:
+ Depreciation & Amortization 34.9 31.2
+ Provision For Income Taxes 36.7 44.3
+ Total Interest Expense 7.6 6.5
Total Adjustments 79.2 82.0
EBITDA From Continuing Operations
EBITDA per Diluted Share $141.7
$2.87 $173.4
$3.67
RECONCILIATION OF STATEMENT OF OPERATIONS
The following table provides a reconciliation of the Company’s Statement of Operations for the Twelve Months Ended December 31, 2016 on a continuing operations basis to that on a combined basis, which takes into account the impact of the Aptevo-related discontinued operations.
Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
Year Ended December 31, 2016
Continuing
Operations Discontinuing
Operations Combined
Revenues: (Unaudited)
Product sales $ 296.3 $ 21.2 317.5
Contract manufacturing 49.1 - 49.1
Contracts and grants 143.4 0.2 143.6
Total revenues 488.8 21.4 510.2
Operating expenses:
Cost of product sales and contract manufacturing 131.3 11.6 142.9
Research and development 108.3 18.0 126.3
Selling, general and administrative 143.7 23.8 167.5
Income from operations 105.5 (32.0 ) 73.5
Other income (expense):
Interest income 1.1 - 1.1
Interest expense (7.6 ) - (7.6 )
Other income, net 0.2 - 0.2
Total other expense, net (6.3 ) (0.0 ) (6.3 )
Income (loss) before provision for (benefit) from income taxes 99.2 (32.0 ) 67.2
Provision for (benefit from) income taxes 36.7 (21.3 ) 15.4
Net income $ 62.5 $ (10.7 ) $ 51.8
OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Year End 2016
On February 23, 2017 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported its year end 2016 financial results (Press release, OncoGenex Pharmaceuticals, FEB 23, 2017, View Source [SID1234517805]). Schedule your 30 min Free 1stOncology Demo! Recent Events
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Schedule Your 30 min Free Demo!
In January 2017, OncoGenex, and Achieve Life Science, Inc., a privately held specialty pharmaceutical company, announced that they have entered into a definitive merger agreement under which OncoGenex will acquire Achieve in an all-stock transaction. Upon completion of the proposed merger, Achieve’s stockholders are expected to own 75% of the combined company’s outstanding shares and current equityholders of OncoGenex are expected to own the remaining 25% of the combined company’s outstanding shares. Following completion of the merger, OncoGenex Pharmaceuticals, Inc. will be renamed Achieve Life Sciences, Inc. The proposed merger is expected to close by mid-2017, subject to customary closing conditions.
In October 2016, the company announced positive survival results from the final analysis of the Phase 2 Borealis-2 trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone.
In February 2017, results from the Pacific Trial were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Genitourinary Cancers Symposium. The trial randomized 72 patients who were experiencing a rising PSA while receiving Zytiga (abiraterone acetate ). Apatorsen was well tolerated in combination with Zytiga with the median treatment duration of 106 days for apatorsen plus Zytiga compared to 75 days for continuing Zytiga alone. The proportion of patients who were progression free at Day 60 was 33% when apatorsen was added to Zytiga, compared to 17% with Zytiga alone.
OncoGenex discontinued the development of its custirsen and OGX-225 programs and is currently seeking a collaboration partnership to further develop apatorsen.
Financial Results
As of December 31, 2016, the company’s cash, cash equivalents, and short-term investments decreased to $25.5 million from $55.2 million as of December 31, 2015. Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations for at least the next 12 months.
Revenue for the fourth quarter and year ended December 31, 2016 was zero and $5.1 million, respectively. The advanced reimbursement payment made by Teva, as part of the Termination Agreement, was deferred and recognized as collaboration revenue on a dollar for dollar basis as costs were incurred as part of the continuing research and development activities related to custirsen. The decrease in collaboration revenue in 2016 as compared to 2015 was due to the full recognition of the remaining amounts of deferred revenue in the first half of 2016.
Total operating expenses for the fourth quarter and year ended December 31, 2016 were $6.0 million and $26.3 million, respectively. Net loss for the fourth quarter and year ended December 31, 2016 was $5.8 million and $20.1 million, respectively.
As of Feb 23, 2017 OncoGenex had 30,086,106 shares outstanding.
Important Additional Information about the Proposed Merger
This communication is being made in respect of the proposed merger involving OncoGenex Pharmaceuticals, Inc. and Achieve Life Science, Inc. OncoGenex intends to file a registration statement on Form S-4 with the SEC, which will contain a joint proxy statement/prospectus and other relevant materials, and plans to file with the SEC other documents regarding the proposed transaction. The final joint proxy statement/prospectus will be sent to the stockholders of OncoGenex and Achieve. The joint proxy statement/prospectus will contain information about OncoGenex, Achieve, the proposed merger and related matters. STOCKHOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS) AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION THAT STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE MERGER AND RELATED MATTERS. In addition to receiving the joint proxy statement/prospectus and proxy card by mail, stockholders will also be able to obtain the joint proxy statement/prospectus, as well as other filings containing information about OncoGenex, without charge, from the SEC’s website (View Source) or, without charge, by directing a written request to: OncoGenex Pharmaceuticals, Inc., 19820 North Creek Parkway, Suite 201, Bothell, WA 98011, Attention: Investor Relations or to Achieve Life Science, Inc., 30 Sunnyside Avenue, Mill Valley, CA 94941, Attention: Rick Stewart.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Participants in Solicitation
OncoGenex and its executive officers and directors may be deemed to be participants in the solicitation of proxies from OncoGenex’s stockholders with respect to the matters relating to the proposed merger. Achieve and its officers and directors may also be deemed a participant in such solicitation. Information regarding OncoGenex’s executive officers and directors is available in OncoGenex’s proxy statement on Schedule 14A, filed with the SEC on April 21, 2016. Information regarding any interest that OncoGenex, Achieve or any of the executive officers or directors of OncoGenex or Achieve may have in the transaction with Achieve will be set forth in the joint proxy statement/prospectus that OncoGenex intends to file with the SEC in connection with its stockholder vote on matters relating to the proposed merger. Stockholders will be able to obtain this information by reading the joint proxy statement/prospectus when it becomes available.
Cyclacel Announces Top-Line Results From Pivotal Phase 3 SEAMLESS Study in Elderly Patients With Acute Myeloid Leukemia
On February 23, 2017 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported top-line results from the pivotal Phase 3 SEAMLESS study in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML), who are not candidates for or have refused intensive induction chemotherapy (Press release, Cyclacel, FEB 23, 2017, View Source [SID1234517804]).
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The trial did not meet its primary endpoint of demonstrating statistically significant improvement in overall survival (OS) for the experimental arm versus an active control. An improved rate of complete remission (CR), a secondary endpoint, was observed in patients who had discontinued therapy at the time of analysis. Other endpoints and safety were similar between the arms. In the stratified subgroup of patients with low baseline peripheral white blood cell count, comprising approximately two-thirds of the study’s population, an improvement in OS was observed for the experimental arm. The opposite was true for patients with high white blood cell count. Full results from the SEAMLESS study will be submitted for presentation at an upcoming medical conference.
"The results of the SEAMLESS Phase 3 study demonstrate that sapacitabine is active and safe in elderly AML patients," said Hagop Kantarjian M.D., Professor and Chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center, and chair of the SEAMLESS study. "Although the experimental arm of alternating decitabine-sapacitabine did not reach statistically significant superiority in overall survival, it is remarkable that an improvement in complete remission rate was observed. Additional analysis of stratified and exploratory subgroups is warranted to identify patients who are most likely to benefit from treatment with the experimental arm."
"We are disappointed not to have reached the primary endpoint of SEAMLESS. Nevertheless, the improvement in CR rate and similar safety profile are encouraging. We plan to discuss the data with European and US regulatory authorities once subgroup analyses are completed over the next few months and will report our further plans as they develop. We are grateful to the clinical investigators, and especially the patients and their families, for their contributions to this large study," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "In parallel with data analysis and regulatory discussions, we will reevaluate our continued investment in sapacitabine in hematological malignancies. Our clinical development strategy in oncology will now concentrate on our two ongoing, clinical programs in DNA damage response and transcriptional regulation, which include our area of historical expertise in CDK inhibitors. These programs target biomarker-selected patients, such as those with BRCA mutations or resistance to existing cancer therapies. Our cash resources are projected to fund these activities and operations through the end of 2018."
Clinical Development Strategy
For the past few years the Company has been progressing clinical investigation of two programs in parallel with the SEAMLESS study based on promising scientific and preclinical data. The DNA damage response program is evaluating an orally-administered, sequential regimen of sapacitabine and seliciclib, a CDK2/9 inhibitor, in patients with BRCA positive, advanced solid cancers. The transcriptional regulation program is evaluating CYC065, a CDK2/9 inhibitor, in patients with advanced cancers with emphasis on downregulation of the Mcl-1 biomarker.
DNA Damage Response Program
Phase 1 data from this program in 67 patients with various advanced cancers were reported at an oral presentation during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Antitumor activity with durable clinical responses was demonstrated in a subgroup of 45 patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. A cohort of breast cancer patients who carry BRCA mutations is being enrolled as an expansion of this study. A further cohort is in preparation which will evaluate alternative dosing schedules and collect more data in BRCA positive patients with solid tumors other than breast cancer. The DNA Damage Response program is benefiting from the historical experience with sapacitabine in hematological malignancies, understanding of its mechanism of action and sizable patient safety database.
Transcriptional Regulation Program
Cyclacel’s second generation CDK2/9 inhibitor, CYC065, is being evaluated in an ongoing, first-in-human, Phase 1 trial in patients with advanced solid tumors. In addition to determining safety and recommended dosing for Phase 2, the study aims to investigate CYC065’s effects on the Mcl-1 biomarker, which is implicated in the evolution of resistance in cancer. The study has reached the seventh dose escalation level without observations of serious toxicity. Evidence of target engagement of prolonged Mcl-1 suppression in peripheral blood cells was observed in patient samples from the study, as well as decreases in kinase substrate phosphorylation and increases in PARP cleavage, which were consistent with the Company’s preclinical data.
Similar to palbociclib, the first CDK inhibitor approved by FDA in 2015, CYC065 may be most useful as a therapy for patients with both liquid and solid tumors in combination with other anticancer agents, including Bcl-2 antagonists, such as venetoclax, or HER2 inhibitors, such as trastuzumab.
Conference Call and Webcast Information:
Cyclacel will hold a conference call on February 23, 2017 at 9:00 a.m. Eastern Time to discuss the Company’s plans with regard to SEAMLESS. Conference call and webcast details are as follows:
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
Code for live and archived conference call is: 77162157
For the live and archived webcast, please visit the Corporate Presentations and Events page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.
About SEAMLESS
The Phase 3, randomized trial compared an investigational arm of oral sapacitabine administered in alternating cycles with intravenous decitabine compared with an active control arm of intravenous decitabine administered alone. The trial was conducted at 110 US and EU sites and randomized 491 patients, over an approximately three year period. Stratification factors at randomization were antecedent hematologic disorders, baseline peripheral white blood cells and baseline bone marrow blasts. In December 2014, the study’s monitoring committee determined after an interim analysis that the futility boundary was crossed. In accordance with the committee’s recommendations, the Company continued to follow up enrolled patients to maturity.
About Sapacitabine
Sapacitabine (CYC682), an orally-available nucleoside analogue, acts through a novel DNA single-strand breaking mechanism, leading to production of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced DSBs is dependent on the homologous recombination repair (HRR) pathway. Both sapacitabine and its major metabolite, CNDAC, have demonstrated potent anti-tumor activity in preclinical studies.
In addition to the SEAMLESS Phase 3 study in elderly patients with AML who were unfit or refused intensive induction chemotherapy, other Phase 2 studies evaluated sapacitabine in patients with myelodysplastic syndromes (MDS), cutaneous T cell lymphoma (CTCL) and non-small cell lung cancer (NSCLC). The US FDA and the European Medicines Agency have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. Sapacitabine is part of Cyclacel’s pipeline of small molecule drugs designed to target and stop uncontrolled cell division.
AVEO Announces TIVO-3 Passes The First Safety Monitoring Committee Safety Review
On February 23, 2017 AVEO Oncology (NASDAQ:AVEO) reported that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC) (Press release, AVEO, FEB 23, 2017, View Source [SID1234517801]). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. Schedule your 30 min Free 1stOncology Demo! As recently announced, the TIVO-3 trial is enrolling substantially ahead of schedule, and with the SMC recommendation to replace early dropouts the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as first and third line treatment for RCC.
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"Tivozanib is a unique molecule in that its high selectivity for VEGF is designed to reduce off target toxicity, thereby increasing tolerability and its combinability with other agents, such as immunotherapies," said Michael Needle, M.D., chief medical officer of AVEO. "We are very pleased to see the pace at which TIVO-3 is enrolling, and that it has completed its first safety review. We look forward to the futility analysis around midyear, and to other potential achievements in our tivozanib clinical program, including the expected first patient treated in the tivozanib and Opdivo combination study, TiNivo, in early March."
About Tivozanib
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.
About the TIVO-3 Trial
The Phase 3 TIVO-3 trial is a pivotal, randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC). The trial is expected to enroll approximately 322 patients with recurrent RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as a first and third line treatment for RCC.