Item 1:
|
Financial Statements
|
MEI PHARMA, INC.
BALANCE SHEETS
(In
thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
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June 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
|
(unaudited)
|
|
|
|
|
ASSETS
|
|
Current assets:
|
|
|
|
|
|
|
|
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Cash and cash equivalents
|
|
$
|
11,644
|
|
|
$
|
10,837
|
|
Short term investments
|
|
|
45,116
|
|
|
|
35,081
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and short-term investments
|
|
|
56,760
|
|
|
|
45,918
|
|
Prepaid expenses and other current assets
|
|
|
2,756
|
|
|
|
831
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
59,516
|
|
|
|
46,749
|
|
Intangible assets, net
|
|
|
340
|
|
|
|
366
|
|
Property and equipment, net
|
|
|
35
|
|
|
|
49
|
|
|
|
|
|
|
|
|
|
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Total assets
|
|
$
|
59,891
|
|
|
$
|
47,164
|
|
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
242
|
|
|
$
|
1,079
|
|
Accrued liabilities
|
|
|
3,711
|
|
|
|
4,433
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|
Deferred revenues
|
|
|
1,036
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total current liabilities
|
|
|
4,989
|
|
|
|
5,512
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|
|
|
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Commitments and contingencies (Note 4)
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|
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|
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|
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Stockholders equity:
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Preferred stock, $0.01 par value; 100,000 shares authorized; none outstanding
|
|
|
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Common stock, $0.00000002 par value; 113,000,000 shares authorized; 36,772,428 and 34,155,997
shares issued and outstanding at March 31, 2017 and June 30, 2016, respectively
|
|
|
|
|
|
|
|
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Additional
paid-in-capital
|
|
|
224,890
|
|
|
|
218,653
|
|
Accumulated deficit
|
|
|
(169,988
|
)
|
|
|
(177,001
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
54,902
|
|
|
|
41,652
|
|
|
|
|
|
|
|
|
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Total liabilities and stockholders equity
|
|
$
|
59,891
|
|
|
$
|
47,164
|
|
|
|
|
|
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|
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See accompanying notes to the unaudited financial statements.
3
MEI PHARMA, INC.
STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended
March 31,
|
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Nine Months Ended
March 31,
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2017
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|
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2016
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|
|
2017
|
|
|
2016
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
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|
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License revenue
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|
$
|
3,779
|
|
|
$
|
|
|
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$
|
20,880
|
|
|
$
|
|
|
Research and development revenue
|
|
|
726
|
|
|
|
|
|
|
|
1,920
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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Total revenues
|
|
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4,505
|
|
|
|
|
|
|
|
22,800
|
|
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|
|
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|
|
|
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Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of research and development revenue
|
|
|
(1,147
|
)
|
|
|
|
|
|
|
(4,012
|
)
|
|
|
|
|
Research and development
|
|
|
(1,876
|
)
|
|
|
(3,420
|
)
|
|
|
(5,164
|
)
|
|
|
(9,418
|
)
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General and administrative
|
|
|
(2,152
|
)
|
|
|
(1,990
|
)
|
|
|
(6,802
|
)
|
|
|
(5,765
|
)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total operating expenses
|
|
|
(5,175
|
)
|
|
|
(5,410
|
)
|
|
|
(15,978
|
)
|
|
|
(15,183
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Income (loss) from operations
|
|
|
(670
|
)
|
|
|
(5,410
|
)
|
|
|
6,822
|
|
|
|
(15,183
|
)
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|
|
|
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Other income (expense):
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|
|
|
|
|
|
|
|
|
|
|
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|
|
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Interest and dividend income
|
|
|
68
|
|
|
|
39
|
|
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|
192
|
|
|
|
92
|
|
Income tax expense
|
|
|
|
|
|
|
|
|
|
|
(1
|
)
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|
|
(1
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)
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Net income (loss)
|
|
$
|
(602
|
)
|
|
$
|
(5,371
|
)
|
|
$
|
7,013
|
|
|
$
|
(15,092
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Earnings (loss) per share, basic
|
|
$
|
(0.02
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
0.19
|
|
|
$
|
(0.44
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Earnings (loss) per share, diluted
|
|
$
|
(0.02
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
0.19
|
|
|
$
|
(0.44
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
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Shares used in computing earnings (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic
|
|
|
37,172,428
|
|
|
|
34,422,663
|
|
|
|
36,693,940
|
|
|
|
34,393,087
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Diluted
|
|
|
37,172,428
|
|
|
|
34,422,663
|
|
|
|
36,760,754
|
|
|
|
34,393,087
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
See accompanying notes to the unaudited financial statements.
4
MEI PHARMA, INC.
STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
|
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|
Nine Months Ended
March 31,
|
|
|
|
2017
|
|
|
2016
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
7,013
|
|
|
$
|
(15,092
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating
activities:
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
2,025
|
|
|
|
2,207
|
|
Depreciation and amortization
|
|
|
42
|
|
|
|
45
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
(1,925
|
)
|
|
|
(600
|
)
|
Accounts payable
|
|
|
(837
|
)
|
|
|
(397
|
)
|
Accrued liabilities
|
|
|
(722
|
)
|
|
|
(537
|
)
|
Deferred revenues
|
|
|
1,036
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
|
6,632
|
|
|
|
(14,374
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(2
|
)
|
|
|
(3
|
)
|
Purchases of short-term investments
|
|
|
(50,110
|
)
|
|
|
(40,190
|
)
|
Proceeds from maturity of short-term investments
|
|
|
40,075
|
|
|
|
50,136
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(10,037
|
)
|
|
|
9,943
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock
|
|
|
4,212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
4,212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
807
|
|
|
|
(4,431
|
)
|
Cash and cash equivalents at beginning of the period
|
|
|
10,837
|
|
|
|
18,722
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of the period
|
|
$
|
11,644
|
|
|
$
|
14,291
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited financial statements.
5
MEI PHARMA, INC.
NOTES TO FINANCIAL STATEMENTS
(Unaudited)
Note
1. The Company
MEI Pharma, Inc., or the Company, is an oncology company focused on the clinical
development of novel therapies for cancer. The Companys common stock is listed on the Nasdaq Capital Market under the symbol MEIP.
The Companys business purpose is the development of drugs for the treatment of cancer. The Companys portfolio of drug candidates
includes Pracinostat, an oral histone deacetylase (HDAC) inhibitor being developed in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive
chemotherapy, and patients with high and very high-risk myelodysplastic syndrome (MDS). In August 2016, the Company entered into an exclusive worldwide license, development and commercialization agreement with Helsinn Healthcare SA, a
Swiss pharmaceutical corporation (Helsinn) for Pracinostat in AML, MDS and other potential indications (Helsinn License Agreement). The Companys clinical development portfolio also includes
ME-401,
an oral inhibitor of phosphatidylinositide
3-kinase
(PI3K) delta currently in a Phase Ib study in patients with relapsed/refractory chronic lymphocytic
leukemia (CLL) or follicular lymphoma, and
ME-344,
a mitochondrial inhibitor currently in an investigator-sponsored study in combination with bevacizumab for the treatment of human epidermal growth
factor receptor 2 (HER2)-negative breast cancer. The Company owns exclusive worldwide rights to
ME-401
and
ME-344.
Basis of Presentation
The accompanying
unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and in accordance with the instructions to Form
10-Q
and Article 10 of Regulation
S-X.
Accordingly, the accompanying financial statements do not include all of the information and notes required by U.S. GAAP for complete
financial statements. In the opinion of management, the accompanying financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations
and cash flows for the periods presented. The Company has evaluated subsequent events through the date the financial statements were issued.
The accompanying unaudited financial statements should be read in conjunction with the audited financial statements and notes thereto as of
and for the fiscal year ended June 30, 2016, included in the Companys Annual Report on Form
10-K
(2016 Annual Report) filed with the Securities and Exchange Commission (SEC)
on September 9, 2016. Interim results are not necessarily indicative of results for a full year.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. The Company uses estimates that affect the reported amounts (including assets, liabilities, revenues and expenses) and related
disclosures. Actual results could materially differ from those estimates.
Revenue Recognition
The Company generates revenues from licensing technology rights and from the conduct of research and development activities. The Company
recognizes revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) the Companys price to the buyer is fixed or
determinable; and (iv) collectability is reasonably assured.
Payments received under commercial arrangements, such as licensing
technology rights, may include
non-refundable
fees at the inception of the arrangements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. The
Company considers a variety of factors in determining the appropriate method of accounting under its license agreements, including whether the various elements can be separated and accounted for individually as separate units of accounting.
Deliverables under an arrangement will be separate units of accounting, provided (i) a delivered item has value to the customer on a standalone basis; and (ii) the arrangement includes a general right of return relative to the delivered
item, and delivery or performance of the undelivered item is considered probable and substantially in the Companys control.
Multiple Element Arrangements
The Company accounts for revenue arrangements with multiple elements by separating and allocating consideration according to the relative
selling price of each deliverable. If an element can be separated, an amount is allocated based upon the relative selling price of each element. The Company determines the relative selling price of a separate deliverable using the price it charges
other customers when it sells that element separately. If the element is not sold separately and third party pricing evidence is not available, the Company will use its best estimate of selling price.
6
License Fee Revenue
The Company defers recognition of
non-refundable
upfront license fees if it has continuing performance
obligations, without which the licensed data, technology, or product has no utility to the licensee separate and independent of its performance under the other elements of the applicable arrangement.
Non-refundable,
up-front
fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the Companys
part are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The specific methodology for the recognition of the revenue is determined on a
case-by-case
basis according to the facts and circumstances of the applicable agreement.
Research and Development Revenue
Research and development revenue represents ratable recognition of fees allocated to research and development activities. The Company defers
recognition of research and development revenue until the performance of the related research and development activities has occurred.
Cost of Research and Development Revenue
Cost of research and development revenue primarily includes external costs paid to third-party contractors to perform research, conduct
clinical trials and develop and manufacture drug materials, and internal compensation and related personnel expenses to support our research and development revenue.
Income Taxes
Deferred income tax assets
and liabilities are recognized for temporary differences between financial statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties surrounding the
Companys ability to generate future taxable income and consequently realize such deferred income tax assets, a full valuation allowance has been established. The Company continues to maintain a full valuation allowance against its deferred tax
assets as of March 31, 2017. The Company has sufficient tax loss carryforwards to offset any potential current year taxable income, therefore no provision for income taxes was recorded during the current period.
The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more likely than not
to be sustained upon audit by the relevant tax authority. An uncertain income tax position will be recognized when it is more likely than not of being sustained. There have been no material changes in the Companys unrecognized tax benefits
since June 30, 2016, and, as such, the disclosures included in the Companys 2016 Annual Report on Form
10-K
for the year ended June 30, 2016 continue to be relevant for the nine-month period
ended March 31, 2017.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No.
2014-09,
Revenue from Contracts with Customers
. The standard provides companies with a single model for accounting for revenue arising from contracts with customers and supersedes current revenue
recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards
transfer to the customer under the existing revenue guidance. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative
adjustment. In August 2015, the FASB issued ASU
2015-14,
Deferral of the Effective Date
, which defers the required adoption date of ASU
2014-09
by one year. As a
result of the deferred effective date, ASU
2014-09
will be effective for the Company in its first quarter of fiscal 2019. Early adoption is permitted but not before the original effective date of the new
standard of the first quarter of fiscal 2018. The following ASUs were subsequently issued by the FASB to clarify the implementation guidance in some areas and add practical expedients: In March 2016, ASU
2016-08,
Revenue from Contracts with Customers, Principal versus Agent Considerations
; in April 2016, ASU
2016-10,
Revenue from Contracts with
Customers, Identifying Performance Obligations and Licensing
; in May 2016, ASU
2016-11,
Revenue from Contracts with Customers and Derivatives and Hedging - Rescission of SEC Guidance
; and ASU
2016-12,
Revenue from Contracts with Customers - Narrow Scope Improvements and Practical Expedients
. The Company is in the process of evaluating the transition method that will be elected and the impact of
adoption on its financial statements.
In August 2014, the FASB issued ASU
No. 2014-15,
Disclosure of Uncertainties About an Entitys Ability to Continue as a Going Concern
(ASU
2014-15).
The standard requires management to perform interim and annual assessments of an
entitys ability to continue as a going concern within one year of the date the financial statements are issued and provides guidance on determining when and how to disclose going concern uncertainties in the financial statements. Certain
disclosures will be required if conditions give rise to substantial doubt about an entitys ability to continue as a going concern. ASU
2014-15
applies to all entities and is effective for annual and
interim reporting periods ending after December 15, 2016. The Company adopted this standard for the quarter ended December 31, 2016, and has applied the guidance in ASU
2014-15
to assess its ability
to continue as a going concern. The Company has concluded that it does not have any issues related to its ability to continue as a going concern.
7
In February 2016, the FASB issued ASU
2016-02,
Leases
, which
introduces the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous guidance. The new standard establishes a
right-of-use
(ROU) model that requires a lessee to record an ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12
months. The new standard is effective for fiscal years beginning after December 15, 2018 and interim periods within those fiscal years with early adoption permitted. The Company is evaluating the impact that the adoption of this standard will
have on its financial statements.
In March 2016, the FASB issued ASU
2016-09,
Improvements to
Employee Share-Based Payment Accounting
, which simplifies several aspects of accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, and classification on
the statement of cash flows. The new standard is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. The Company is evaluating the impact that the adoption of
this standard will have on its financial statements.
In June 2016, the FASB issued
No. 2016-13,
Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
. Topic 326 amends guidance on reporting credit losses for assets held
at amortized cost basis and available for sale debt securities. For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current U.S. GAAP and, instead, requires an entity to reflect its current
estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt
securities, credit losses should be measured in a manner similar to current U.S. GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. ASU
2016-13
affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit
exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. This update is effective for fiscal years beginning after December 15, 2019, including interim
periods within those fiscal years. The Company is currently evaluating the impact the adoption of this standard will have on its financial statements.
Note 2. Helsinn License Agreement
On August 5, 2016, the Company entered into the Helsinn License Agreement with Helsinn. Under the terms of the agreement, Helsinn has been
granted a worldwide exclusive license to develop, manufacture and commercialize Pracinostat, and is primarily responsible for funding its global development and commercialization. As compensation for such grant of rights, the Company received a
$15.0 million upfront payment in August 2016 and an additional $5.0 million payment in March 2017. The Company will also receive reimbursement related to agreements entered into by MEI in anticipation of the upcoming Phase III study of
Pracinostat by Helsinn as well as a Phase II study for Pracinostat in combination with azacitidine for the treatment of high and very high risk MDS, which will be conducted by MEI (the POC study). The current expected external cost of
the Phase II study will be shared equally by Helsinn and the Company. Enrollment in the Phase II study is anticipated to commence in the second quarter of calendar year 2017. The Company will be eligible to receive up to $444 million in
potential regulatory and sales-based milestones, along with royalty payments on the net sales of Pracinostat.
The Company determined that
the exclusive license, development and commercialization agreement represents a multiple-element arrangement for purposes of revenue recognition. The Company identified the following elements, based upon deliverables under the agreement:
(i) worldwide license and transfer of technology and data; (ii) completion of the conduct of certain identified clinical trials related to Pracinostat; (iii) coordination of services provided by third-party vendors related to research
and development activities, for which Helsinn has agreed to reimburse such third-party expenses; and (iv) the conduct of the POC study, for which Helsinn has agreed to share third-party expenses. The license was determined to represent a
separate element as it has stand-alone value and is not dependent upon the performance of the research and development activities. The research and development elements, related to the conduct of clinical trials and services provided by third-party
vendors, were determined to represent separate elements as they primarily represent pass through of services performed by third parties and therefore are sold separately by other vendors. The Company allocated the proceeds related to the agreement
to the units of accounting using the relative selling price method. The Company determined the estimated selling price for the license using the assistance of a third-party valuation specialist, and the Company determined the estimated selling price
for the research and development elements by using the prices charged by the respective third party vendors. Revenue of $3.8 million and $20.9 million, respectively, related to the license was recognized during the three and nine months
ended March 31, 2017. Revenue related to the research and development elements of the arrangement are recognized based on the proportional performance of each research and development activity. Research and development revenues are recognized
on a gross basis as the Company is the primary obligor and has discretion in supplier selection.
Contemporaneously with the Helsinn
License Agreement, the Company entered into a Common Stock Purchase Agreement (the Helsinn Equity Agreement), dated as of August 5, 2016, with Helsinn Investment Fund SA (the Purchaser). Pursuant to the terms of the
Helsinn Equity Agreement, the Purchaser agreed to purchase and the Company agreed to issue a number of shares of the Companys common stock determined by dividing $5,000,000 by the volume weighted-average price for shares of the Companys
8
common stock for the
10-trading-day-period
beginning on August 1, 2016
and ending on August 12, 2016 (the VWAP), rounded to the nearest whole share. The VWAP was $1.911 per share. Accordingly, on August 16, 2016, the Company issued 2,616,431 shares of common stock. The multiple-element
arrangements guidance contains a presumption that separate contracts entered into at or near the same time with the same entity or related parties were negotiated together and should be evaluated as a single agreement. Therefore, the difference
between the VWAP of $1.911 per share and the closing price of the Companys common stock on August 5, 2016 of $1.61 per share, totaling $0.8 million, has been allocated as additional consideration related to the revenue elements.
Note 3. Earnings (Loss) Per Share
Basic earnings (loss) and diluted net loss per share are computed using the weighted-average number of shares of common stock outstanding
during the period, less any shares subject to repurchase or forfeiture. There were no shares of common stock subject to repurchase or forfeiture for the three and nine months ended March 31, 2017 and 2016. Diluted earnings per share is computed
based on the sum of the weighted average number of common shares and potentially dilutive common shares outstanding during the period.
The following table presents the calculation of weighted average shares used to calculate basic and diluted earnings (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
Nine Months Ended
March 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Weighted average shares outstanding
|
|
|
36,772,428
|
|
|
|
34,155,997
|
|
|
|
36,323,624
|
|
|
|
34,155,997
|
|
Effect of vested restricted stock units
|
|
|
400,000
|
|
|
|
266,666
|
|
|
|
370,316
|
|
|
|
237,090
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in calculating basic earnings per share
|
|
|
37,172,428
|
|
|
|
34,422,663
|
|
|
|
36,693,940
|
|
|
|
34,393,087
|
|
Effect of potentially dilutive common shares from equity awards
|
|
|
|
|
|
|
|
|
|
|
66,814
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in calculating diluted earnings per share
|
|
|
37,172,428
|
|
|
|
34,422,663
|
|
|
|
36,760,754
|
|
|
|
34,393,087
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Potentially dilutive shares shares excluded from calculation due to anti-dilutive effect
|
|
|
8,069,528
|
|
|
|
6,694,158
|
|
|
|
7,583,217
|
|
|
|
6,554,186
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 4. Commitments and Contingencies
The Company has contracted with various consultants and third parties to assist it in
pre-clinical
research and development and clinical trials work for its leading drug compounds. The contracts are terminable at any time, but obligate the Company to reimburse the providers for any time and costs incurred through the date of termination. The
Company also has employment agreements with certain of its current employees that provide for severance payments and accelerated vesting for share-based awards if their employment is terminated under specified circumstances.
As of March 31, 2017, the Company leases approximately 8,800 square feet of office space for the Companys executive and
administrative offices. The monthly rental rate is approximately $29,000 during the remaining term of the lease, plus a
pro-rata
share of certain building expenses. The lease expires in June 2017. Total future
minimum payments under the lease are $86,000 through June 30, 2017.
In April 2017, the Company entered into a lease agreement for
approximately 13,700 square feet of office space at a monthly rental rate of approximately $44,000 per month during the term of the lease, commencing July 1, 2017 and expiring in May 2020.
Asset Purchase Agreement
In August 2012, the Company entered into a definitive asset purchase agreement with S*Bio Pte Ltd (S*Bio), pursuant to which the
Company agreed to acquire certain assets comprised of intellectual property and technology including rights to Pracinostat, in exchange for $500,000 of common stock. In August 2012, the Company completed the asset purchase and issued 195,756 shares
of common stock to S*Bio. The Company has also agreed to make certain milestone payments to S*Bio based on the achievement of certain clinical, regulatory and net sales-based milestones, as well as to make certain contingent earnout payments to
S*Bio. Milestone payments will be made to S*Bio up to an aggregate amount of $75.2 million if certain U.S., E.U. and Japanese regulatory approvals are obtained and if certain net sales thresholds are met in North America, the E.U. and Japan.
The first milestone payment of $200,000 payable in cash, plus $500,000 payable in cash or in shares of the Companys common stock, will be due upon the first dosing of a patient in a Phase III clinical trial or other pivotal trial, for any
indication. Subsequent milestone payments will be due upon certain regulatory approvals and sales-based events. As of March 31, 2017, the Company has accrued $0.7 million for potential future payments.
CyDex License Agreement
In September 2012, the Company entered into a license agreement with CyDex Pharmaceuticals, Inc. (CyDex). Under the license
agreement, CyDex granted to the Company an exclusive, nontransferable license to intellectual property rights relating to Captisol
®
for use with the Companys isoflavone-based drug
compounds. The Company agreed to pay to CyDex a
non-refundable
license issuance fee, future milestone payments, and royalties at a low, single-digit percentage on future sales of the Companys approved
drugs utilizing Captisol. Contemporaneously with the license agreement, the Company and CyDex entered into a commercial supply agreement pursuant to which the Company agreed to purchase 100% of its requirements for Captisol from CyDex. The Company
may terminate both the license agreement and the supply agreement for convenience at any time upon 90 days prior written notice. As of March 31, 2017, the Company has not accrued any amounts for potential future payments.
9
Note 5. Short-Term Investments
As of March 31, 2017 and June 30, 2016, the Companys short-term investments consisted of $45.1 million and
$35.1 million, respectively, in U.S. government securities. The short-term investments held as of March 31, 2017 and June 30, 2016 had maturity dates of less than one year, are considered to be held to maturity and are
carried at amortized cost. Due to the short-term maturities of these instruments, the amortized cost approximates the related fair values. As of March 31, 2017 and June 30, 2016, the gross holding gains and losses were immaterial.
Note 6. Stockholders Equity
Equity Transactions
Shelf Registration Statement
In April 2014, the Company filed a shelf registration statement on Form
S-3
with the SEC (shelf
registration statement). The shelf registration statement was declared effective by the SEC in April 2014. The shelf registration statement permits the Company to sell, from time to time, up to $150.0 million of common stock, preferred
stock and warrants. As of March 31, 2017, there is $104.0 million aggregate value of securities available under the shelf registration statement. The shelf registration expired in April 2017.
Helsinn Equity Investment
On August 5, 2016, the Company entered into the Helsinn Equity Agreement. Pursuant to the terms of the Helsinn Equity Agreement, the
Company issued 2,616,431 shares of common stock on August 16, 2016. The transaction was exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended.
Warrants
As of March 31, 2017,
there were outstanding warrants to purchase 315,484 shares of the Companys common stock at an exercise price of $7.14 per share, which expire in May 2017, issued in conjunction with the Companys May 2012 rights offering, and warrants to
purchase 3,230,202 shares of the Companys common stock at an exercise price of $3.12 per share, which expire in December 2017, issued in conjunction with its December 2012 private placement.
Note 7. Share-based Compensation
The Company uses equity-based compensation programs to provide long-term performance incentives for its employees. These incentives consist
primarily of stock options and restricted stock units (RSUs).
MEI Pharmas 2008 Stock Omnibus Equity Compensation Plan
(the 2008 Equity Plan) provides for the grant of options and/or other share-based or share-denominated awards to the Companys
non-employee
directors, officers, employees and advisors. The
2008 Equity Plan was initially adopted in 2008 and was amended and restated in 2011, 2013, 2014, and 2015. Effective December 1, 2016, the Companys stockholders voted to further amend and restate the 2008 Equity Plan to increase the
number of shares of common stock authorized for issuance under the plan to 10,186,000 shares, among other changes. As of March 31, 2017, there were 5,065,940 shares available for future grant under the 2008 Equity Plan.
Total share-based compensation expense for all stock awards consists of the following, in thousands:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
Nine Months Ended March 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Research and development
|
|
$
|
213
|
|
|
$
|
216
|
|
|
$
|
695
|
|
|
$
|
681
|
|
General and administrative
|
|
|
401
|
|
|
|
423
|
|
|
|
1,330
|
|
|
|
1,526
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation
|
|
$
|
614
|
|
|
$
|
639
|
|
|
$
|
2,025
|
|
|
$
|
2,207
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
Stock Options
Stock option activity for the nine months ended March 31, 2017 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
Options
|
|
|
Weighted-
Average
Exercise Price
|
|
|
Weighted-Average
Remaining Contractual
Term (in years)
|
|
|
Aggregate
Intrinsic Value
|
|
Outstanding at June 30, 2016
|
|
|
2,827,172
|
|
|
$
|
4.29
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
1,527,083
|
|
|
|
1.37
|
|
|
|
|
|
|
|
|
|
Forfeited / Cancelled
|
|
|
(33,333
|
)
|
|
|
1.36
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(54,630
|
)
|
|
|
9.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2017
|
|
|
4,266,292
|
|
|
$
|
3.21
|
|
|
|
6.7
|
|
|
$
|
467,597
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at March 31, 2017
|
|
|
2,017,037
|
|
|
$
|
4.54
|
|
|
|
4.9
|
|
|
$
|
81,367
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value of each stock option granted during the nine months ended March 31, 2017 is estimated on
the grant date under the fair value method using a Black-Scholes valuation model. Stock options granted to employees during the nine months ended March 31, 2017 vest 25% one year from the date of grant and ratably each month thereafter for a
period of 36 months and expire ten years from the date of grant. Stock options granted to directors during the nine months ended March 31, 2017 vest ratably each month for a period of 12 months from the date of grant and expire ten years from
the date of grant. The RSU equity awards are measured using the grant date fair value of the Companys common stock. The estimated fair values of the stock options and RSUs, including the effect of estimated forfeitures, are expensed over the
service period.
The following weighted-average assumptions were used to determine the fair value of options granted during the period:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended March 31,
|
|
|
|
2017
|
|
|
2016
|
|
Risk-free interest rate
|
|
|
1.2
|
%
|
|
|
1.7
|
%
|
Expected life (years)
|
|
|
5.9
|
|
|
|
5.8
|
|
Expected volatility
|
|
|
108.2
|
%
|
|
|
116.8
|
%
|
Dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Weighted-average grant date fair value
|
|
$
|
1.12
|
|
|
$
|
1.35
|
|
As of March 31, 2017, there was $1.4 million of unrecognized compensation expense related to the
unvested portion of stock options. Such compensation expense is expected to be recognized over a weighted-average period of 1.5 years.
Restricted Stock Units
In March 2013, the Compensation Committee of the Board of Directors granted 400,000 RSUs to the Companys Chief Executive Officer,
Dr. Daniel P. Gold. Each RSU represents the contingent right to receive one share of the Companys common stock.
One-third
of the RSUs vested on August 30, 2014,
one-third
vested on August 30, 2015, and the remaining
one-third
vested on August 30, 2016. The shares underlying the RSUs will be delivered to Dr. Gold on the
earliest to occur of (i) March 29, 2018, (ii) Dr. Golds death, disability or separation from service from the Company for any reason, or (iii) a change in control involving the Company. The fair value of the RSUs on the
date of grant was $3.5 million. The grant date fair value per unit was $8.63.
In June 2016, the Company granted 364,726 RSUs to
employees. Each RSU represents the contingent right to receive one share of the Companys common stock. The RSUs were subject to performance criteria that were met in August 2016. The RSUs will vest in August 2018. The fair value of the RSUs
was measured at $1.61 per unit on the date the performance criteria were met. Under the terms of the 2008 Plan, each of these RSUs is calculated as 1.25 shares of common stock for purposes of determining the number of shares available for future
grant. There were 363,014 unvested RSUs outstanding as of March 31, 2017.
As of March 31, 2017, unrecognized compensation
expense related to the unvested portion of the Companys RSUs was approximately $0.4 million and is expected to be recognized over approximately 1.3 years.
11
Item 2:
|
Managements Discussion and Analysis of Financial Condition and Results of Operations
|
This Quarterly Report on Form
10-Q
includes forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended (the Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical
facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words believe,
may, will, estimate, continue, anticipate, intend, should, plan, expect, and similar expressions, as they relate to us, are intended to
identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations,
business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, without limitation, those described in Risk Factors in our 2016 Annual Report, and
elsewhere in this report, including, among other things:
|
|
|
our inability to obtain required additional financing or financing available to us on acceptable terms, or at all, which may cause us to delay, scale-back or eliminate plans related to development of our drug
candidates;
|
|
|
|
Helsinn or other parties with which we have entered into collaboration, license, development and/or commercialization agreements may not satisfy their obligations under the agreements which could impact future revenues;
|
|
|
|
we are in early stage clinical studies for our product candidates on which our development plans are based; clinical studies by their nature typically have a high level of risk and may not produce successful results;
|
|
|
|
the results of
pre-clinical
studies and completed clinical trials are not necessarily predictive of future results, and our current drug candidates may not have favorable results
in later studies or trials;
|
|
|
|
our inability to maintain or enter into, and the risks resulting from our dependence upon, contractual arrangements necessary for the clinical development, manufacture, commercialization, marketing, sales and
distribution of our product candidates;
|
|
|
|
costs and delays in our clinical development programs and/or receipt of U.S. Food and Drug Administration (FDA) or other required governmental or regulatory approvals, or the failure to obtain such
approvals, for our product candidates;
|
|
|
|
the FDAs interpretation and our interpretation of data from preclinical and clinical studies may differ significantly;
|
|
|
|
our failure to successfully commercialize our product candidates;
|
|
|
|
the failure of any products to gain market acceptance;
|
|
|
|
our inability to control the costs of manufacturing our products;
|
|
|
|
our reliance on acquisitions or licenses from third parties to expand our pipeline of drug candidates;
|
|
|
|
competition and competitive factors;
|
|
|
|
our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business;
|
|
|
|
our inability to operate our business without infringing the patents and proprietary rights of others;
|
|
|
|
costs stemming from our defense against third party intellectual property infringement claims;
|
|
|
|
general economic conditions;
|
|
|
|
government regulation generally;
|
|
|
|
changes in industry practice; and
|
These risks are not exhaustive.
Other sections of this report and our other filings with the SEC include additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk
factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
You should not rely upon forward-looking statements as predictions of
future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we
cannot guarantee future results, levels of activity, performance or achievements. Past performance may not be an indicator of future results. The following discussion is qualified in its entirety by, and should be read in conjunction with, the more
detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form
10-Q
and the audited financial statements and notes thereto included in our
2016 Annual Report, as filed with the SEC. Operating results are not necessarily indicative of results that may occur in future periods.
Overview and
Recent Developments
We are an oncology company focused on the clinical development of novel therapies for cancer. Our common stock is
listed on the Nasdaq Capital Market under the symbol MEIP.
12
Our business purpose is the development of drugs for the treatment of cancer. Our portfolio of
clinical drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of patients with newly diagnosed AML who are
³
75 years of
age or
18-74
years of age and unfit for intensive chemotherapy, and patients with high or very high-risk MDS. In August 2016, we entered into an exclusive worldwide license, development and commercialization
agreement with Helsinn for Pracinostat in AML, MDS and other potential indications. Our clinical development portfolio also includes
ME-401,
an oral inhibitor of PI3K delta being developed for
B-cell
malignancies, and
ME-344,
a mitochondrial inhibitor that has shown evidence of clinical activity in refractory solid tumors. We own exclusive worldwide rights to
ME-401
and
ME-344.
Clinical Development Programs
HDAC Inhibitor Drug Candidate: Pracinostat
In August 2016, we announced that the FDA granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the
treatment of patients with newly diagnosed AML who are unfit for intensive chemotherapy. In addition, agreement has been reached with the FDA on the proposed Phase III study design. According to the FDA, Breakthrough Therapy Designation is intended
to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at
least one clinically significant endpoint over available therapy.
The Breakthrough Therapy Designation is supported by data from a Phase
II study of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML who are not candidates for induction chemotherapy. The study showed a median overall survival of 19.1 months and a complete response (CR) rate of 42% (21 of 50
patients). These data compare favorably to a recent international Phase III study of azacitidine
(AZA-001;
Dombret et al.
Blood
. 2015 May 18), which showed a median overall survival of 10.4 months with
azacitidine alone and a CR rate of 19.5% in a similar patient population. The combination of Pracinostat and azacitidine was generally well tolerated, with no unexpected toxicities. The most common grade 3/4 treatment-emergent adverse events
included febrile neutropenia, thrombocytopenia, anemia and fatigue.
In August 2016, we entered into an exclusive license, development and
commercialization agreement with Helsinn, a Swiss pharmaceutical corporation, for Pracinostat in AML, MDS and other potential indications (Helsinn License Agreement). Under the terms of the agreement, Helsinn is granted a worldwide
exclusive license to develop, manufacture and commercialize Pracinostat, and is primarily responsible for funding its global development and commercialization. As compensation for such grant of rights, we received payments of $20.0 million,
including a $15.0 million upfront payment in August 2016 and a $5.0 million payment in March 2017. In addition, we will be eligible to receive up to $444 million in potential regulatory and sales-based milestones, along with royalty
payments on the net sales of Pracinostat, which, in the U.S., are tiered and begin in the
mid-teens.
As part of the Helsinn License Agreement, we will work with Helsinn to determine an optimal dosing regimen of Pracinostat in combination with
azacitidine for the treatment of high and very high-risk MDS. The cost of this study will be shared by Helsinn and us and enrollment is anticipated to commence in the second quarter of calendar year 2017.
PI3K Delta Drug Candidate:
ME-401
In September 2013, we acquired exclusive worldwide rights to
ME-401
from Pathway Therapeutics, Inc. for
an undisclosed upfront cash payment with no future milestone or royalty obligations. Data from
pre-clinical
studies show
ME-401
to be a potent and selective oral
inhibitor of PI3K delta, a molecular target that plays a critical role in the proliferation and survival of certain hematologic cancer cells. PI3K delta is a class of drugs that has shown promise in the treatment of
B-cell
malignancies, but with particular toxicities. We believe this provides an opportunity for development of a next-generation oral drug that can produce therapeutic responses at a safe, effective dose.
ME-401
has a distinct chemical structure from certain other PI3K delta inhibitors, including idelalisib (marketed as Zydelig
®
). Data presented at the ASH
Annual Meeting in December 2012 demonstrated that
ME-401
has superior
pre-clinical
activity compared to idelalisib.
Results from a
first-in-human,
single ascending dose clinical
study of
ME-401
in healthy volunteers were presented at the American Association for Cancer Research Annual Meeting in April 2016. The data demonstrated
on-target
activity at very low plasma concentrations. In addition, the results from the study suggest that
ME-401
has the potential for a superior pharmacokinetic and pharmacodynamic profile and an improved therapeutic
window compared to idelalisib, with a half-life that supports once-daily dosing. In March 2016, the FDA approved our Investigational New Drug application for
ME-401
in
B-cell
malignancies. A Phase Ib dose-escalation study of
ME-401
in patients with relapsed/refractory CLL or follicular lymphoma opened for enrollment in September 2016.
The goal of the study is to demonstrate an improved therapeutic window with repeated dosing in cancer patients. This study is now actively dosing patients and interim data are expected in June 2017.
Mitochondrial Inhibitor Drug Candidate:
ME-344
ME-344
is our isoflavone-derived mitochondrial inhibitor drug candidate. In preclinical studies,
ME-344
has been shown to cause cell death in multiple human tumor cell lines, including ovarian cancer stem cells, by interfering with mitochondrial energy generation.
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Results from our
first-in-human,
single-agent Phase I clinical trial of
ME-344
in patients with refractory solid tumors were published in the
April 1, 2015 issue of
Cancer
. The results indicated that eight of 21 evaluable patients (38%) treated with
ME-344
achieved stable disease or better, including five who experienced progression-free
survival that was at least twice the duration of their last prior treatment before entry into the study. In addition, one of these patients, a heavily
pre-treated
patient with small cell lung cancer, achieved
a confirmed partial response and remained on study for two years.
ME-344
was generally well tolerated at doses equal to or less than 10 mg/kg delivered on a weekly schedule for extended durations.
Treatment-related adverse events included nausea, dizziness and fatigue. Dose limiting toxicities were observed at both the 15 mg/kg and 20 mg/kg dose levels, consisting primarily of Grade 3 peripheral neuropathy.
In May 2015, we announced new
pre-clinical
data from a collaboration with the Spanish National Cancer
Research Centre in Madrid showing mitochondria-specific effects of
ME-344
in cancer cells, including substantially enhanced anti-tumor activity when combined with agents that inhibit the activity of vascular
endothelial growth factor (VEGF). These new data demonstrate that the anti-cancer effects when combining
ME-344
with a VEGF inhibitor are due to an inhibition of both mitochondrial and glycolytic
metabolism. An investigator-sponsored study of
ME-344
in combination with the VEGF inhibitor bevacizumab (marketed as Avastin
®
) in HER2-negative breast
cancer opened for enrollment in August 2016. This study is now actively dosing patients and interim data are expected in December 2017.
Results of
Operations
Three Months Ended March 31, 2017 and 2016
We had a net loss of $0.6 million for the three months ended March 31, 2017 compared to a net loss of $5.4 million for the three
months ended March 31, 2016.
License Revenue:
We recognized license revenue of $3.8 million for the three months ended
March 31, 2017 compared to no license revenue for the three months ended March 31, 2016. The license revenue resulted from receipt of a $5.0 million payment from Helsinn in March 2017.
Research and Development Revenue:
We recognized research and development revenue of $0.7 million for the three months ended March 31,
2017 compared to no research and development revenue for the three months ended March 31, 2016. The research and development revenue resulted from the recognition of fees allocated to research and development activities in accordance with the
Helsinn License Agreement which was signed in August 2016.
Cost of Research and Development Revenue:
We recognized cost of research and
development revenue of $1.1 million for the three months ended March 31, 2017 compared to no cost of research and development revenue for the three months ended March 31, 2016. The cost of research and development revenue includes
external costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials, and internal compensation and related personnel expenses to support our research and development revenue.
Research and Development
:
Research and development expenses consist primarily of clinical trial costs (including payments to contract
research organizations),
pre-clinical
study costs, costs to manufacture our drug candidates for
non-clinical
and clinical studies and salaries and other personnel costs.
Research and development expenses decreased by $1.5 million to $1.9 million for the three months ended March 31, 2017 compared to $3.4 million for the three months ended March 31, 2016. The decrease was primarily due to a
reduction in expenses related to Pracinostat pursuant to our license agreement with Helsinn, under which Helsinn will be primarily responsible for funding the development and commercialization of Pracinostat.
General and Administrative
:
General and administrative expenses increased by $0.2 million to $2.2 million for the three months
ended March 31, 2017 compared to $2.0 million for the three months ended March 31, 2016. The increase is primarily due to higher levels of professional services expenses associated with the Helsinn License Agreement.
Other income or expense:
We received interest and dividend income of $68,000 for the three months ended March 31, 2017 compared to $39,000
for the three months ended March 31, 2016. The increase was due to higher investment balances and higher yields during the three months ended March 31, 2017 compared to the three months ended March 31, 2016.
Nine months Ended March 31, 2017 and 2016
We had net income of $7.0 million for the nine months ended March 31, 2017 compared to a net loss of $15.1 million for the nine
months ended March 31, 2016.
License Revenue:
We recognized license revenue of $20.9 million for the nine months ended
March 31, 2017 compared to no license revenue for the nine months ended March 31, 2016. The license revenue resulted from the completion of the performance obligations related to the upfront license fees in accordance with the Helsinn
License Agreement which was signed in August 2016.
Research and Development Revenue:
We recognized research and development revenue of
$1.9 million for the nine months ended March 31, 2017 compared to no research and development revenue for the nine months ended March 31, 2016. The research and development revenue resulted from the recognition of fees allocated to
research and development activities in accordance with the Helsinn License Agreement which was signed in August 2016.
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Cost of Research and Development Revenue:
We recognized cost of research and development revenue of
$4.0 million for the nine months ended March 31, 2017 compared to no cost of research and development revenue for the nine months ended March 31, 2016. The cost of research and development revenue includes external costs paid to
third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials, and internal compensation and related personnel expenses to support our research and development revenue.
Research and Development
:
Research and development expenses consist primarily of clinical trial costs (including payments to contract
research organizations),
pre-clinical
study costs, costs to manufacture our drug candidates for
non-clinical
and clinical studies and salaries and other personnel costs.
Research and development expenses decreased by $4.2 million to $5.2 million for the nine months ended March 31, 2017 compared to $9.4 million for the nine months ended March 31, 2016. The decrease was primarily due to a
reduction in clinical trial costs associated with Pracinostat and with
ME-344,
including a reduction of clinical trial costs of $1.9 million due to revisions in estimates of amounts that are owed to
contract research organizations for clinical trials for Pracinostat and
ME-344
that are at or near completion. In addition, expenses related to Pracinostat decreased pursuant to our license agreement with
Helsinn, under which Helsinn will be primarily responsible for funding the development and commercialization of Pracinostat.
General and
Administrative
:
General and administrative expenses increased by $1.0 million to $6.8 million for the nine months ended March 31, 2017 compared to $5.8 million for the nine months ended March 31, 2016. The
increase is primarily due to professional services expenses associated with the Helsinn License Agreement during the nine months ended March 31, 2017.
Other income or expense:
We received interest and dividend income of $192,000 for the nine months ended March 31, 2017 compared to $92,000
for the nine months ended March 31, 2016. The increase was due to higher yields during the nine months ended March 31, 2017 compared to the nine months ended March 31, 2016.
Liquidity and Capital Resources
We have
accumulated losses of $170.0 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of March 31, 2017, we had $56.8 million in cash, cash
equivalents and short-term investments, which we believe will be sufficient to fund our operations through at least calendar year 2018. Our current business operations are focused on continuing the clinical development of our drug candidates.
Changes to our research and development plans or other changes affecting our operating expenses may affect actual future use of existing cash resources. To date, we have obtained cash and funded our operations primarily through equity financings. In
order to continue the development of our drug candidates, at some point in the future we expect to pursue one or more capital transactions, whether through the sale of equity securities, license agreements or entry into strategic partnerships.
Sources and Uses of Our Cash
Net cash provided by operations for the nine months ended March 31, 2017 was $6.6 million compared to $14.4 million used in
operations for the nine months ended March 31, 2016. The increase in cash provided by operations is primarily due to the $20.0 million in upfront payments received as part of the Helsinn License Agreement.
Net cash used in investing activities for the nine months ended March 31, 2017 was $10.0 million compared to net cash provided by
investing activities of $9.9 million in the nine months ended March 31, 2016. Cash used in investing activities represents purchases of investments in short-term U.S. government securities in excess of maturities.
Net cash provided by financing activities for the nine months ended March 31, 2017 was $4.2 million, representing the equity
investment made by Helsinn in a transaction related to the Helsinn License Agreement. There was no cash provided by financing activities during the nine months ended March 31, 2016.
Contractual Obligations
We have
contracted with various consultants and third parties to assist us in
pre-clinical
research and development and clinical trials work for our leading drug compounds. The contracts are terminable at any time,
but obligate us to reimburse the providers for any time or costs incurred through the date of termination. Additionally, we have employment agreements with certain of our current employees that provide for severance payments and accelerated vesting
for share-based awards if their employment is terminated under specified circumstances.
As of March 31, 2017, we lease approximately
8,800 square feet of office space at a monthly rental rate of approximately $29,000 per month during the term of the lease, through June 2017.
In April 2017, we entered into a lease agreement for approximately 13,700 square feet of office space at a monthly rental rate of
approximately $44,000 per month during the term of the lease, commencing July 1, 2017 and expiring in May 2020.
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CyDex License Agreement
In September 2012, the Company entered into a license agreement with CyDex. Under the license agreement, CyDex granted to the Company an
exclusive, nontransferable license to intellectual property rights relating to Captisol
®
for use with the Companys isoflavone-based drug compounds. The Company agreed to pay to CyDex a
non-refundable
license issuance fee, future milestone payments, and royalties at a low, single-digit percentage rate on future sales of the Companys approved drugs utilizing Captisol. Contemporaneously with
the license agreement, the Company and CyDex entered into a commercial supply agreement pursuant to which the Company agreed to purchase 100% of its requirements for Captisol from CyDex. The Company may terminate both the license agreement and the
supply agreement for convenience at any time upon 90 days prior written notice.
S*Bio Asset Purchase
In August 2012, we entered into a definitive asset purchase agreement with S*Bio, pursuant to which we agreed to acquire certain assets
comprised of intellectual property and technology including rights to Pracinostat, in exchange for $500,000 of common stock. On August 22, 2012, we completed the asset purchase and issued 195,756 shares of common stock to S*Bio. We also agreed
to make certain milestone payments to S*Bio based on the achievement of certain clinical, regulatory and net sales-based milestones, as well as to make certain contingent earnout payments to S*Bio. Milestone payments will be made to S*Bio up to an
aggregate amount of $75.2 million if certain U.S., E.U. and Japanese regulatory approvals are obtained and if certain net sales thresholds are met in North America, the E.U. and Japan. The first milestone payment of $200,000 payable in cash,
plus $500,000 payable in cash or in shares of the Companys common stock, will be due upon the first dosing of a patient in a Phase III clinical trial or other pivotal trial, for any indication. Subsequent milestone payments will be due upon
certain regulatory approvals and sales-based events. As of March 31, 2017, the Company has accrued $0.7 million for potential future payments.
Critical Accounting Policies and Management Estimates
We describe our significant accounting policies in Note 1, The Company and Summary of Significant Accounting Policies, of the notes to
financial statements included in our 2016 Annual Report. We discuss our critical accounting estimates in Item 7, Managements Discussion and Analysis of Financial Condition and Results of Operations, in our 2016 Annual Report. There have been
no changes in our significant accounting policies or critical accounting estimates since June 30, 2016, other than the adoption of revenue recognition policies as a result of the Helsinn License Agreement.
In August 2016, we entered into the Helsinn License Agreement. Under the terms of the agreement, Helsinn has been granted a worldwide
exclusive license to develop, manufacture and commercialize Pracinostat, and is primarily responsible for funding its global development and commercialization. As compensation for such grant of rights, we received a $15.0 million upfront
payment in August 2016 and an additional $5.0 million payment in March 2017. We will also receive reimbursement related to agreements entered into by MEI in anticipation of the upcoming Phase III study of Pracinostat by Helsinn as well as a
Phase II study for Pracinostat in combination with azacitidine for the treatment of high and very high risk MDS, which will be conducted by MEI. The current expected external cost of the Phase II study will be shared equally by Helsinn and us.
Enrollment in the Phase II study is anticipated to commence in the second quarter of calendar year 2017. We will be eligible to receive up to $444 million in potential regulatory and sales-based milestones, along with royalty payments on the
net sales of Pracinostat.
We have determined that the exclusive license, development and commercialization agreement represents a
multiple-element arrangement for purposes of revenue recognition. The Company identified the following elements, based upon deliverables under the agreement: (i) worldwide license and transfer of technology and data; (ii) completion of the
conduct of certain identified clinical trials related to Pracinostat; (iii) coordination of services provided by third-party vendors related to research and development activities, for which Helsinn has agreed to reimburse such third-party
expenses; and (iv) the conduct of the POC study, for which Helsinn has agreed to share third-party expenses. The license was determined to represent a separate element as it has stand-alone value and is not dependent upon the performance of the
research and development activities. The research and development elements, related to the conduct of clinical trials and services provided by third-party vendors, were determined to represent separate elements as they primarily represent pass
through of services performed by third parties and therefore are sold separately by other vendors. We allocated the proceeds related to the agreement to the units of accounting using the relative selling price method. We determined the estimated
selling price for the license using the assistance of a third party valuation specialist, and we determined the estimated selling price for the research and development elements by using the prices charged by the respective third party vendors.
Revenue of $22.8 million related to the license was recognized during the nine months ended March 31, 2017, pursuant to delivery of the technology and data transfer. Revenue related to the research and development elements of the
arrangement are recognized based on the proportional performance of each research and development activity. Research and development revenues are recognized on a gross basis as the Company is the primary obligor and has discretion in supplier
selection.
Contemporaneously with the Helsinn License Agreement, we entered into a Common Stock Purchase Agreement (the Helsinn
Equity Agreement), dated as of August 5, 2016, with Helsinn Investment Fund SA (the Purchaser). Pursuant to the terms of the Helsinn Equity Agreement, the Purchaser agreed to purchase and we agreed to issue a number of shares
of our common stock determined by dividing $5,000,000 by the volume weighted-average price for shares of our common stock for the
10-trading-dayperiod
beginning on
August 1, 2016 and ending on August 12, 2016 (the VWAP), rounded to the nearest whole share. The VWAP was $1.911 per share. Accordingly, on August 16, 2016, we issued 2,616,431 shares of common stock. The multiple-element
16
arrangements guidance contains a presumption that separate contracts entered into at or near the same time with the same entity or related parties were negotiated together and should be evaluated
as a single agreement. Therefore, the difference between the VWAP of $1.911 per share and the closing price of our common stock on August 5, 2016 of $1.61 per share, totaling $0.8 million, has been allocated as additional consideration
related to the revenue elements.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No.
2014-09,
Revenue from Contracts with Customers
. The standard provides companies with a single model for accounting for revenue arising from contracts with customers and supersedes current revenue
recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards
transfer to the customer under the existing revenue guidance. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative
adjustment. In August 2015, the FASB issued ASU
2015-14,
Deferral of the Effective Date
, which defers the required adoption date of ASU
2014-09
by one year. As a
result of the deferred effective date, ASU
2014-09
will be effective for the Company in its first quarter of fiscal 2019. Early adoption is permitted but not before the original effective date of the new
standard of the first quarter of fiscal 2018. The following ASUs were subsequently issued by the FASB to clarify the implementation guidance in some areas and add practical expedients: In March 2016, ASU
2016-08,
Revenue from Contracts with Customers, Principal versus Agent Considerations
; in April 2016, ASU
2016-10,
Revenue from Contracts with
Customers, Identifying Performance Obligations and Licensing
; in May 2016, ASU
2016-11,
Revenue from Contracts with Customers and Derivatives and Hedging - Rescission of SEC Guidance
; and ASU
2016-12,
Revenue from Contracts with Customers - Narrow Scope Improvements and Practical Expedients
. We are in the process of evaluating the transition method that will be elected and the impact of adoption
on our financial statements.
In August 2014, the FASB issued ASU
No. 2014-15,
Disclosure
of Uncertainties About an Entitys Ability to Continue as a Going Concern
. The standard requires management to perform interim and annual assessments of an entitys ability to continue as a going concern within one year of the date the
financial statements are issued and provides guidance on determining when and how to disclose going concern uncertainties in the financial statements. Certain disclosures will be required if conditions give rise to substantial doubt about an
entitys ability to continue as a going concern. ASU
2014-15
applies to all entities and is effective for annual and interim reporting periods ending after December 15, 2016. The Company adopted this
standard for the quarter ended December 31, 2016, and has applied the guidance in ASU
2014-15
to assess its ability to continue as a going concern. We have concluded that we do not have any issues related
to our ability to continue as a going concern.
In February 2016, the FASB issued ASU
2016-02
Leases
, which introduces the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous guidance. The new standard establishes a
right-of-use
(ROU) model that requires a lessee to record an ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. The new standard is effective for
fiscal years beginning after December 15, 2018 and interim periods within those fiscal years with early adoption permitted. We are evaluating the impact that the adoption of this standard will have on our financial statements.
In March 2016, the FASB issued ASU
2016-09
Improvements to Employee Share-Based Payment
Accounting
, which simplifies several aspects of accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows.
The new standard is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. We are evaluating the impact that the adoption of this standard will have on our
financial statements.
In June 2016, the FASB issued
No. 2016-13,
Financial Instruments
Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
. Topic 326 amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities. For assets held at
amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current U.S. GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation
account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt securities, credit losses should be measured in a manner similar to current U.S. GAAP,
however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. ASU
2016-13
affects entities holding financial assets and net investment in leases that are not
accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from
the scope that have the contractual right to receive cash. This update is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. We are currently evaluating the impact the
adoption of this standard will have on our financial statements.
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