UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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Large accelerated filer | ☐ | Accelerated filer | ☐ | |
☒ | Smaller reporting company | |||
Emerging growth company | ||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of August 9th, 2021, the registrant had
Table of Contents
“Milestone Pharmaceuticals” and the Milestone logo appearing in this Quarterly Report on Form 10-Q are unregistered trademarks of Milestone Pharmaceuticals Inc. All other trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
This Quarterly Report on Form 10-Q contains references to United States dollars and Canadian dollars. All dollar amounts referenced, unless otherwise indicated, are expressed in United States dollars. References to “$” are to United States dollars and references to “C$” are to Canadian dollars.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "positioned," "potential," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.
We have based these forward-looking statements largely on our 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 known and unknown risks, uncertainties and assumptions, including risks described in the section titled "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q, regarding, among other things:
| ● | the initiation, timing, progress and results of our current and future clinical trials of etripamil, including our Phase 3 clinical trials of etripamil for the treatment of paroxysmal supraventricular tachycardia, our Phase 2 clinical trial of etripamil for the treatment of atrial fibrillation with rapid ventricular rate, and of our research and development programs; |
| ● | uncertain impacts that the COVID-19 pandemic may have on our business, strategy, clinical trial progress and research and development efforts; |
| ● | our plans to develop and commercialize etripamil and any future product candidates; |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
| ● | our ability to develop and, if approved by regulatory authorities, commercialize etripamil in China and Taiwan through our license agreement with Ji Xing Pharmaceuticals; |
| ● | our ability to establish collaborations or obtain additional funding; |
| ● | our ability to obtain regulatory approval of our current and future product candidates; |
| ● | our expectations regarding the potential market size and the rate and degree of market acceptance of etripamil and any future product candidates; |
| ● | our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources; |
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| ● | the implementation of our business model and strategic plans for our business, etripamil and any future product candidates; |
| ● | our intellectual property position and the duration of our patent rights; |
| ● | developments or disputes concerning our intellectual property or other proprietary rights; |
| ● | our expectations regarding government and third-party payer coverage and reimbursement; |
| ● | our ability to compete in the markets we serve; |
| ● | the impact of government laws and regulations; |
| ● | developments relating to our competitors and our industry; and |
| ● | the factors that may impact our financial results. |
The foregoing list of risks is not exhaustive. Other sections of this Quarterly Report on Form 10-Q and the section titled "Risk Factors" previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K may include additional factors that could harm 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 our management 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, or implied by, any forward-looking statements.
In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled "Risk Factors" previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K, filed with the SEC on March 29, 2021, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Milestone Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands of US dollars, except share data)
| June 30, 2021 |
| December 31, 2020 | |||
Assets |
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Current assets |
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Cash and cash equivalents | $ | |
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Short-term investment (note 4) | | | ||||
Research and development tax credits receivable | |
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Prepaid expenses | |
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Other receivables | |
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Total current assets | |
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Operating lease right-of-use assets | | | ||||
Property and equipment | |
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Total assets | $ | |
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Liabilities |
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Current liabilities |
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Accounts payable and accrued liabilities (note 5) | $ | |
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Current portion of operating lease liabilities | |
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Total current liabilities | |
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Operating lease liabilities | |
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Total liabilities | |
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Shareholders’ Equity (note 6) |
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Share capital |
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Common shares, | |
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Pre-funded warrants - | | | ||||
Additional paid-in capital | |
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Cumulative translation adjustment | ( |
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Accumulated deficit | ( |
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Total shareholders’ equity | |
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Total liabilities and shareholders’ equity | $ | |
| $ | | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Income (Loss)
(Unaudited)
(thousands of US dollars, except share and per share data)
Three months ended June 30, | Six months ended June 30, | |||||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | |||||
Collaboration revenue (note 3) | $ | |
| $ | — | $ | |
| $ | — | ||
Operating expenses |
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Research and development, net of tax credits |
| $ | |
| $ | | $ | |
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General and administrative |
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Commercial |
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Income (Loss) from operations |
| $ | |
| $ | ( | $ | ( |
| $ | ( | |
Interest income, net of bank charges |
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Net income (loss) for the period |
| $ | |
| $ | ( | $ | ( |
| $ | ( | |
Weighted average number of shares and pre-funded warrants outstanding, basic | | | | |||||||||
Net income (loss) per share, basic (note 8) |
| $ | |
| $ | ( | $ | ( |
| $ | ( | |
Weighted average number of shares and pre-funded warrants outstanding, diluted | | | | | ||||||||
Net income (loss) per share, diluted (note 8) |
| $ | |
| $ | ( | $ | ( |
| $ | ( | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Shareholders’ Equity
(Unaudited)
(thousands of US dollars, except per share data)
Common Shares | Pre-funded warrants | |||||||||||||||||||||
| Number |
| Amount |
| Number |
| Amount |
| Additional |
| Cumulative |
| Accumulated |
| Total | |||||||
Balance as of December 31, 2019 | | $ | | — | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in three-month period ended March 31, 2020 | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options (note 7) | | | — | — | ( | — | — | | ||||||||||||||
Share-based compensation (note 7) | — | — | — | — | | — | — | | ||||||||||||||
Balance as of March 31, 2020 | | $ | | — | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in three-month period ended June 30, 2020 | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options (note 7) | | | — | — | ( | — | — | | ||||||||||||||
Share-based compensation (note 7) | — | — | — | — | | — | — | | ||||||||||||||
Balance as of June 30, 2020 | | $ | | — | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||
Balance as of December 31, 2020 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in three-month period ended March 31, 2021 | ||||||||||||||||||||||
Net loss | — | — | — | — | — | — | ( | ( | ||||||||||||||
Exercise of stock options (note 7) | | | — | — | ( | — | — | | ||||||||||||||
Share-based compensation (note 7) | — | — | — | — | | — | — | | ||||||||||||||
Balance as of March 31, 2021 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Transactions in three-month period ended June 30, 2021 | ||||||||||||||||||||||
Net income | — | — | — | — | — | — | | | ||||||||||||||
Private Placement (note 7) | — | — | | | — | — | — | | ||||||||||||||
Share-based compensation (note 7) | — | — | — | — | | — | — | | ||||||||||||||
Balance as of June 30, 2021 | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(thousands of US dollars)
Six months ended June 30, | ||||||
2021 |
| 2020 | ||||
Cash flows from | ||||||
Operating activities | ||||||
Net loss for the period | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Amortization of property and equipment | | | ||||
Share-based compensation expense (note 7) | | | ||||
Changes in operating assets and liabilities: | ||||||
Other receivables | ( | ( | ||||
Research and development tax credits receivable | ( | | ||||
Prepaid expenses | ( | ( | ||||
Operating lease right of use asset, net | | ( | ||||
Accounts payable and accrued liabilities | ( | ( | ||||
Net cash used in operating activities | ( | ( | ||||
Investing Activities | ||||||
Acquisition of short-term investments | — | ( | ||||
Redemption of short-term investments | | — | ||||
Cash provided by (used in) investing activities | | ( | ||||
Financing activities | ||||||
Issuance of common shares on exercise of share options (note 7) | | | ||||
Net proceeds from issuance of pre-funded warrants in a private placement (note 6) | | — | ||||
Cash provided by financing activities | | | ||||
Net increase (decrease) in cash and cash equivalents during the period | | ( | ||||
Cash and cash equivalents – Beginning of period | | | ||||
Cash and cash equivalents – End of period | $ | | $ | | ||
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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1 Organization and nature of operations
Milestone Pharmaceuticals Inc. (Milestone or the Company) is a biopharmaceutical company incorporated under the Business Corporations Act of Québec. Milestone is focused on the development and commercialization of cardiovascular medicines. Milestone’s lead product candidate, etripamil, is a novel, potent short-acting calcium channel blocker that the Company designed and is developing as a rapid-onset nasal spray to be administered by patients. The Company is developing etripamil to treat paroxysmal supraventricular tachycardia, atrial fibrillation, and other cardiovascular indications.
2 Summary of significant accounting policies
a) Basis of consolidation
The consolidated financial statements include the accounts of the Company and Milestone Pharmaceuticals USA, Inc. All intercompany transactions and balances have been eliminated.
b) Basis of presentation and use of accounting estimates and significant accounting policies
These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP) and on a basis consistent with those accounting principles followed by the Company and disclosed in note 2 of its most recent annual consolidated financial statements. Certain information, in particular the accompanying notes normally included in the annual financial statements prepared in accordance with US GAAP have been omitted or condensed. Accordingly, the unaudited interim condensed consolidated financial statements do not include all the information required for full annual financial statements, and therefore, should be read in conjunction with the annual consolidated financial statements and the notes thereto for the year ended December 31, 2020.
In the opinion of the Company's management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of its balance sheet as of June 30, 2021, and its statements of income (loss), shareholders’ equity for the three and six months ended June 30, 2021 and 2020 and its statement of cash flows for the six months ended June 30, 2021.
The condensed consolidated balance sheet as of December 31, 2020, was derived from audited annual consolidated financial statements, but does not contain all the footnote disclosures required by accounting principles generally accepted in the United States of America.
These unaudited interim condensed consolidated financial statements are presented in US dollars, which is the Company’s functional currency.
The preparation of unaudited interim condensed consolidated financial statements with US GAAP requires the Company to make estimates and judgments that affect certain reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the period. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes are reasonable under the circumstances, to determine the carrying values of assets and liabilities that are not readily apparent from other sources. Significant estimates and judgments include, but are not limited to, research and development tax credits recoverable, progress of activities performed by the Contract Resource Organizations (CROs) and Contract Manufacturing Organizations (CMOs) which are used to calculate the research and development expense incurred, and share-based compensation. Accordingly, actual results may differ from those estimates and such differences may be material.
The Company’s significant accounting policies are described in Note 2—Summary of Significant Accounting Policies, in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020. There has been no material change to the significant accounting policies during the six months ended June 30, 2021, except for the addition of the new policies described below.
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Collaborative Arrangements
The Company considers the nature and contractual terms of arrangements and assesses whether an arrangement involves a joint operating activity pursuant to which the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity. If the Company is an active participant and is exposed to significant risks and rewards dependent on the commercial success of the activity, the Company accounts for such an arrangement as a collaborative arrangement under Accounting Standards Codification (ASC) 808, Collaborative Arrangements (ASC 808), which requires that certain transactions between the Company and collaborators be recorded in its consolidated statements of comprehensive income (loss) on either a gross basis or net basis, depending on the characteristics of the collaborative relationship, and requires enhanced disclosure of collaborative relationships. The Company evaluates its collaboration agreements for proper classification in its consolidated statements of comprehensive income (loss) based on the nature of the underlying activity. If payments to and from collaborative partners are not within the scope of other authoritative accounting literature, the consolidated statements of income (loss) classification for the payments is based on a reasonable, rational analogy to authoritative accounting literature that is applied in a consistent manner. If the Company concludes that it has a customer relationship with one of its collaborators, the Company follows the guidance in Accounting Standards Codification (ASC) Topic 606, Revenue From Contracts With Customers (ASC 606).
Please refer to note 3, “Collaboration Revenue” for additional details regarding the Company’s License and Collaboration Agreement (the License Agreement) with Ji Xing Pharmaceuticals, Limited (Ji Xing).
Revenue from Contracts with Customers
In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled in exchange for these goods and services. To achieve this core principle, the Company applies the following five steps: 1) identify the customer contract; 2) identify the contract’s performance obligations; 3) determine the transaction price; 4) allocate the transaction price to the performance obligations; and 5) recognize revenue when or as a performance obligation is satisfied. The Company evaluates all promised goods and services within a customer contract and determines which of such goods and services are separate performance obligations. This evaluation includes an assessment of whether the good or service is capable of being distinct and whether the good or service is separable from other promises in the contract. In assessing whether promised goods or services in licensing arrangements are distinct, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. Licensing arrangements are analyzed to determine whether the promised goods or services, which often include licenses, research and development services and governance committee services, are distinct or whether they must be accounted for as part of a combined performance obligation. If the license is considered not to be distinct, the license would then be combined with other promised goods or services as a combined performance obligation. If the Company is involved in a governance committee, it assesses whether its involvement constitutes a separate performance obligation. When governance committee services are determined to be separate performance obligations, the Company determines the fair value to be allocated to this promised service. Certain contracts contain optional and additional items, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. An option that is considered a material right is accounted for as a separate performance obligation. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. A contract may contain variable consideration, including potential payments for both milestone and research and development services. For certain potential milestone payments, the Company estimates the amount of variable consideration by using the most likely amount method. In making this assessment, the Company evaluates factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the milestone. Each reporting period the Company re-evaluates the probability of achievement of such variable consideration and any related constraints. Milestone will include variable consideration, without constraint, in the transaction price to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
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If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price among the performance obligations on a relative standalone selling price basis unless a portion of the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct good or service that forms part of a single performance obligation.
The Company allocates the transaction price based on the estimated standalone selling price of the underlying performance obligations or in the case of certain variable consideration to one or more performance obligations. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs to complete the respective performance obligation. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amount the Company would expect to receive for each performance obligation.
When a performance obligation is satisfied, revenue is recognized for the amount of the transaction price, excluding estimates of variable consideration that are constrained, that is allocated to that performance obligation on a relative standalone selling price basis. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement.
For performance obligations consisting of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non- refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license.
c) Significant Risks and Uncertainties
The COVID-19 pandemic has had an impact on our business, operations and clinical development timelines. Government orders and restrictions in order to control the spread of the disease have impacted patient recruitment, enrollment and follow-up visits at clinical sites. With the global spread of the ongoing COVID-19 pandemic, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic will continue to have an impact on the development timelines for its clinical programs. The extent to which the COVID-19 pandemic continues to impact its business, its clinical development and regulatory efforts, its corporate development objectives and the value of and market for its common shares will depend on future developments that remain highly uncertain and cannot be predicted with confidence at this time, such as the evolution of new variants, the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company’s business, financial condition, results of operations and growth prospects.
In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its product candidate; delays or problems in the supply of its study drug or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its intellectual property rights; and complying with applicable regulatory requirements.
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d) Recent Accounting Pronouncements
The Company has considered recent accounting pronouncements and concluded that they are either not applicable to the business or that the effect is not expected to be material to the unaudited condensed consolidated financial statements as a result of future adoption.
e) Sources of Liquidity and Funding Requirements
On May 15, 2021, the Company entered into the License Agreement with Ji Xing, which is an entity affiliated with RTW Investments, LP, (RTW) a beneficial owner of approximately
The Company has incurred operating losses in all periods except the three months ended June 30, 2021 and has experienced negative operating cash flows since its inception with the exception of the three months ended June 30, 2021 and anticipates to continue to incur losses for at least the next several years. As of June 30, 2021, the Company had cash, cash equivalents and short-term investments of $
3 Collaboration revenue
General
To date, the Company has not generated revenue from product sales. During the quarter ended June 30, 2021, the Company recognized collaboration revenue of $
Under the License Agreement, the Company could receive the following potential milestone payments in addition to the $
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Development | Sales | |||||
Ji Xing License and Collaboration Agreement | $ | | $ | | ||
Total Potential Milestone Payments | $ | | $ | | ||
Strategic Partnerships
Ji Xing
Pursuant to the License Agreement, the Company granted Ji Xing exclusive development and commercialization rights to any pharmaceutical product that uses a device to deliver the Company’s proprietary calcium channel blocker known as etripamil by nasal spray for all prophylactic and therapeutic uses in humans in the Territory.
Ji Xing will be responsible for development and regulatory activities in the Territory, and the Company will remain responsible for certain manufacturing activities in the Territory, subject to the Supply Agreement.
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Milestone received a non-refundable upfront cash payment consisting of $
The Company has determined that the License Agreement is within the scope of ASC 808 as the Company and Ji Xing are both active participants in the development and manufacturing activities and are exposed to significant risks and rewards that are dependent on commercial success of the activities of the arrangement. Further, Milestone determined that Ji Xing is not a customer for goods or services resulting from ordinary activities of the Company. The Company has concluded that the License Agreement is within the scope of ASC 808, which defines collaborative arrangements and addresses the presentation of the transactions between the
Management evaluated all of the promised goods or services within the contract and determined which such goods and services were separate performance obligations. The Company determined that the license granted was a separate performance obligation as Ji Xing can benefit from the license granted on its own after the transfer of the license, as it does not require any significant development, regulatory or commercialization activities from Milestone. Ji Xing is responsible for all development, regulatory and commercialization activities in the Territory, including the performance of clinical trials necessary for regulatory approval, and is responsible for all such related costs. Supply of the product can be provided by another entity, as Milestone currently uses a CMO for the production of etripamil without subsequent significant modification or customization by the Company, therefore the Company determined the obligation to supply product is a separate and distinct obligation. The Company concluded that the obligation for participation on the various governance committees was distinct as the services could be performed by an outside party, however it was determined to be immaterial after estimating the stand alone cost compared to the License Agreement as a whole. As a result, the Company concluded there were
The Company determined that the transaction price consists of the $
In conjunction with the License Agreement, Ji Xing acquired $
For Ji Xing’s subsequent purchases of product pursuant to the Supply Agreement, each order will be accounted for as a separate purchase and the order price will be allocated to the products based on the standalone selling price of the products. Under this methodology, the order price will be allocated to the single performance obligation to supply the products. As Milestone has not previously licensed a product for a territory, the residual approach was used by deducting the estimated stand-alone selling price of the other obligations from the total transaction price to determine the stand-alone selling price of the remaining goods and services, which consisted of the transfer of intellectual property pursuant to the license. Therefore, the remaining transaction price of $
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million was recognized at that point in time as collaboration revenue in the related statement of comprehensive income (loss).
4 Short-term investments
Short-term investments are comprised of term deposits issued in US currency. These short-term investments are in scope of ASC 320, Investments - Debt Securities, since the short-term investments maturity is greater than 90 days but less than one year, they are classified as held to maturity, recorded as current assets and are accounted for at amortized cost.
5 Accounts payable and accrued liabilities
Accounts payable and accrued liabilities are comprised of the following:
| June 30, 2021 | December 31, 2020 | ||||
Trade accounts payable |
| $ | | $ | | |
Accrued research and development liabilities |
| | | |||
Other accrued liabilities |
| | | |||
Accrued compensation and benefits payable |
| | | |||
| $ | | $ | | ||
6 Shareholders’ equity
Authorized share capital
The Company has authorized and issued common shares, voting and participating, without par value, of which unlimited shares were authorized and
As of June 30, 2021, there were
Additional paid-in capital
Three months ended June 30, | Six months ended June 30, | ||||||||||||
2021 |
| 2020 | 2021 |
| 2020 | ||||||||
Opening balance | $ | |
| $ | $ | |
| $ | | ||||
Share-based compensation expense | |
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Exercise of stock options | — |
| ( | ( |
| ( | |||||||
Closing balance | $ | |
| $ | | $ | |
| $ | | |||
Pre-funded warrants
On May 15, 2021, the Company entered into a securities purchase agreement to sell and issue in a private placement pre-funded warrants to purchase up to
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7 Shareholders’ equity
Under the Company’s 2019 Equity Incentive Plan (the 2019 Plan) and the Company’s Stock Option Plan (the 2011 Plan), unless otherwise decided by the Board of Directors, options vest and are exercisable as follows:
On January 1, 2021, the number of the Company’s common shares reserved for issuance under the 2019 Plan increased by
The total outstanding and exercisable options from the 2011 Plan and 2019 Plan as of June 30 were as follows:
2021 | 2020 | |||||||||||||||||||||
Weighted | Weighted | |||||||||||||||||||||
Number | average | Number | average | |||||||||||||||||||
of shares | exercise | of shares | exercise | |||||||||||||||||||
| 2019 Plan |
| 2011 Plan |
| Total |
| price |
| 2019 Plan |
| 2011 Plan |
| Total |
| price | |||||||
Outstanding at beginning of year - 2011 Plan |
| — | | | $ | |
| — | | | $ | | ||||||||||
Outstanding at beginning of year - 2019 Plan | | — | | | | — | | | ||||||||||||||
Granted - 2019 Plan | | — | | | | — | | | ||||||||||||||
Exercised - 2011 Plan | — | ( | ( | | — | ( | ( | | ||||||||||||||
Exercised - 2019 Plan | ( | — | ( | | — | — | — | — | ||||||||||||||
Forfeited - 2011 Plan |
| — | — | — | — |
| — | ( | ( | | ||||||||||||
Forfeited - 2019 Plan | ( | — | ( | | ( | — | ( | | ||||||||||||||
Cancelled - 2019 Plan | ( | — | ( | |
| — | — | — | — | |||||||||||||
Outstanding at end of period |
| | | | $ | |
| | | | $ | | ||||||||||
Outstanding at end of period - Weighted average exercise price | $ | | $ | | $ | | $ | | ||||||||||||||
Exercisable at end of period | | | | $ | | | | | $ | | ||||||||||||
Exercisable at end of period - Weighted average exercise price |
| $ | | $ | |
| $ | | $ | | ||||||||||||
The weighted average remaining contractual life was
There was $
Options granted are valued using the Black-Scholes option pricing model. Amortization of the fair value of the options over vesting years has been expensed and credited to additional paid-in capital in shareholders’ equity.
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The non-vested options as of June 30 were as follows:
2021 | 2020 | ||||||||||||||||||
Number | Weighted | Number | Weighted | ||||||||||||||||
of options | average | of options | average | ||||||||||||||||
| 2019 Plan | 2011 Plan |
| Total |
| fair value |
|
| 2019 Plan | 2011 Plan |
| Total |
| fair value | |||||
Non-vested share options at beginning of year - 2011 Plan |
| — | | |
| $ | |
|
| — | | |
| $ | | ||||
Non-vested share options at beginning of year - 2019 Plan | | — | |
| $ | | | — | |
| $ | | |||||||
Granted - 2019 Plan |
| | — | | |
| | — | | | |||||||||
Vested, outstanding 2011 Plan | — | ( | ( |
| |
| — | ( | ( |
| | ||||||||
Vested, outstanding 2019 Plan | ( | — | ( | | ( | — | ( | | |||||||||||
Forfeited - 2011 Plan |
| — | — | — |
| — |
|
| — | ( | ( |
| | ||||||
Forfeited - 2019 Plan | ( | — | ( | | ( | — | ( | | |||||||||||
Non-vested share options at end of period |
| | | |
| $ | |
|
| | | |
| $ | | ||||
Non-vested share options at end of period - Weighted average fair value | $ | | $ | | $ | | $ | | |||||||||||
The fair value of share-based payment transaction is measured using Black-Scholes valuation model. This model also requires assumptions, including expected option life, volatility, risk-free interest rate and dividend yield, which greatly affect the calculated values.
The fair value of options granted was estimated using the Black-Scholes option pricing model, resulting in the following weighted average assumptions for the options granted:
Three months ended June 30, | Six months ended June 30, | ||||||||||||
2021 |
| 2020 |
| 2021 |
| 2020 |
| ||||||
Exercise price | $ | |
| $ | | $ | |
| $ | | |||
Share price | $ | |
| $ | | $ | |
| $ | | |||
Volatility |
| | % | | % |
| | % | | % | |||
Risk-free interest rate |
| | % | | % |
| | % | | % | |||
Expected life |
|
|
|
| |||||||||
Dividend |
| % | % |
| % | % | |||||||
Expected volatility is determined using comparable companies for which the information is publicly available. The risk-free interest rate is determined based on the U.S. sovereign rates benchmark in effect at the time of grant with a remaining term equal to the expected life of the option. Expected option life is determined based on the simplified method as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. The simplified method is an average of the contractual term of the options and its ordinary vesting period. Dividend yield is based on the share option’s exercise price and expected annual dividend rate at the time of grant.
The Company recognized share-based compensation expense as follows:
Three months ended June 30, | Six months ended June 30, | |||||||||||
| 2021 |
| 2020 | 2021 |
| 2020 | ||||||
Administration |
| $ | | $ | | $ | |
| $ | | ||
Research and development |
| | | |
| | ||||||
Commercial activities |
| | | |
| | ||||||
| $ | | $ | | $ | |
| $ | | |||
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8 Net income (loss) per share
Basic net income (loss) per common share is determined by dividing net income (loss) applicable to common shareholders by the weighted average number of common shares and pre-funded warrants outstanding during the period.
For the three months ended June 30, 2021 the Company was in a net income position, therefore diluted net income per common share includes dilutive securities. Dilutive net income per common share is determined by dividing net income applicable to common shareholders by the weighted average number of common shares, shares issuable on exercise of pre-funded warrants outstanding during the period and the shares issuable on exercise of options outstanding and in the money during the period. The dilutive securities consisted of
For the for three months ended June 30, 2020 and the six months ended June 30, 2021 and 2020, the Company was in a net loss position. Dilutive net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average number of common shares and shares issuable upon exercise of pre-funded warrants outstanding during the period. The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares three months ended June 30, 2020 and the six months ended June 30, 2021 and 2020 outstanding as of June 30 as they would be anti-dilutive:
| 2021 |
| 2020 | |
Share options |
| |
| |
Amounts above reflect the common share equivalents of the noted instruments.
15
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission, or SEC, on March 29, 2021. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed in “Risk Factors” and in other parts of this Quarterly Report on Form 10-Q.
Overview
We are a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Our lead product candidate etripamil is a novel, potent and short-acting calcium channel blocker that we designed as a rapid-onset nasal spray to be self-administered by patients. We are developing etripamil to treat paroxysmal supraventricular tachycardia, or PSVT, atrial fibrillation with rapid ventricular rate, or AFib-RVR, and other cardiovascular indications.
Etripamil - Pivotal Clinical Program in PSVT
PSVT is a rapid heart rate condition characterized by episodes of supraventricular tachycardia, or SVT, that start and stop without warning. Episodes of SVT are often experienced by patients with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting and anxiety. Calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. Calcium channel blockers available in oral form are frequently used prophylactically to control the frequency and duration of future episodes of SVT. For treatment of episodes of SVT, approved calcium channel blockers are administered intravenously under medical supervision, usually in the emergency department. The combination of convenient nasal-spray delivery, rapid-onset and short duration of action of etripamil has the potential to shift the current treatment paradigm for episodes of SVT away from the burdensome and costly emergency department setting. If approved, we believe that etripamil will be the first self-administered therapy for the rapid termination of episodes of SVT wherever and whenever they occur.
In March 2020, we reported topline results of the first part of the NODE-301 pivotal trial of etripamil for the treatment of PSVT, which is a placebo-controlled Phase 3 safety and efficacy trial. The first part of NODE-301, which enrolled a total of 431 patients across 65 sites in the United States and Canada, did not meet its primary endpoint of time to conversion of SVT to sinus rhythm compared to placebo over the five hour period in which patients wore a cardiac monitor following study drug administration.
In July 2020, we announced that we received guidance from the U.S. Food and Drug Administration, or FDA, on our proposal to alter the size and design of our ongoing RAPID trial as well as the overall program based on the data from the NODE-301 trial. The FDA indicated that the two trials, the RAPID trial and the completed NODE-301 trial, could potentially fulfill the efficacy requirement for our planned NDA for etripamil in patients with PSVT.
Under an updated statistical analysis plan, or SAP, the primary efficacy endpoint for both the RAPID and NODE-301 trials will be defined as time to conversion over the first 30 minutes, with a target p-value of less than 0.05 for each trial. This endpoint supports the desire of patients to rapidly address their PSVT symptoms during an episode and ideally avoid visiting the emergency department. Later and earlier time points will also be assessed as part of secondary analyses to fully characterize the efficacy profile of etripamil.
When employing the updated SAP retrospectively to the NODE-301 data, the analysis results in 54% of etripamil patients vs. 35% of placebo patients converted within 30 minutes (HR 1.87, p=0.02). We also discussed the clinical benefit of 54% conversion rate with the FDA. We believe, based on interactions with PSVT treating physicians and cardiovascular thought leaders, that a 50% conversion rate within 60 minutes is a clinically-meaningful outcome given the symptomatic nature of SVT episodes and the lack of approved at-home treatments.
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Based on discussions with the FDA regarding maximizing the treatment effect of etripamil, the RAPID trial will allow for repeat administration of study drug (either 70 mg of etripamil or placebo) for patients who have not experienced symptom relief within ten minutes of the first study drug administration. This repeat dose regimen, which is similar to current PSVT treatment practices in the emergency department setting, is tailored to the pharmacokinetic profile of etripamil to deliver increased exposure over approximately the first 30 minutes following initial administration. We expect that the repeat administration could benefit a broader group of patients, including those with more persistent episodes.
The RAPID study, which was originally designed to collect double-blind data from randomized patients who had not yet experienced an SVT event after the NODE-301 study reached its target number of adjudicated SVT events, will be amended and expanded to serve as a pivotal efficacy and safety study should the RAPID study meet its primary objective. The study will include the 170 patients who are already enrolled, although many of those patients have been enrolled in the study for more than one year without reporting an SVT event. The study will be completed after a total of 180 confirmed SVT events are reached, including those that have already occurred in the study. Additional patients to be enrolled in the RAPID study will be randomized 1:1.
The FDA agreed that the single and repeat administrations of etripamil could be pooled and compared to placebo for the primary analysis, resulting in no increase in the study’s sample size.
We initiated the RAPID study in the second half of 2020 and enrolled the first new patient in November of 2020. In the fourth quarter of 2020, we took initiatives to increase the number of clinical trial sites in North America but also planned for more clinical sites in European countries to diversify and better protect the study recruitment against COVID’s geographical resurgences. We expect the majority of planned clinical trial sites in Europe will be initiated through the first three quarters of 2021. We continue to monitor enrollment as well as new clinical site activations and expect to report topline data in the second half of 2022.
Etripamil - Safety Studies in PSVT
NODE-302 is our Phase 3 open-label safety extension of the NODE-301 trial. Patients who completed NODE-301 could enroll in NODE-302 and receive up to an additional 11 doses of etripamil. NODE-302 is a multi- center, open label study designed to evaluate the safety of etripamil nasal spray when self-administered by patients without medical supervision for spontaneous episodes of SVT in an outpatient setting. Eligibility was also contingent on satisfying all inclusion and exclusion criteria, including not experiencing a serious adverse event related to the study drug or the study procedure that precludes the self-administration of etripamil. We completed NODE-302 in late 2020 with a data set of 245 episodes with 105 patients dosed at least once out of 169 patients enrolled. Trial results will contribute to the etripamil NDA safety database.
NODE-303 is a Phase 3, multi-center, open-label safety trial, evaluating the safety of etripamil when self-administered without medical supervision, and evaluating the treatment safety and efficacy of etripamil on multiple SVT episodes. We originally designed this trial to enroll enough patients to collect data on 1,000 patients taking etripamil in an at-home setting. With the expanded size of the RAPID trial, we expect the size of the NODE-303 study to be reduced. We will determine a more accurate sizing of the trial following future discussions with the FDA and other regulatory authorities. Based on a review of the NODE-301 safety data available in June 2019, the FDA and multiple European and Latin American regulatory authorities agreed to allow patient enrollment in NODE-303 without an in-office safety test dose, which is required in the NODE-301 trial, and in a broad patient population including patients taking concomitant beta blockers and calcium channel blockers. In a manner similar to that used in starting NODE-303 based on safety data from the NODE-301 trial, we have engaged in discussion with the FDA about introducing, in NODE-303, the etripamil repeat dose regimen (70 mg etripamil administered ten minutes after the initial dose if symptoms persist) currently used in RAPID. Based on a review of the RAPID safety data available until March 2021, the FDA has agreed to allow future patients enrolled in NODE-303 to utilize the repeat dose regimen. We are in the process of implementing the repeat dose regimen in the study.
We have initiated and continue to expand patient access programs that have as their primary objective providing further access to etripamil to patients who have participated in the clinical development registration trials to treat future SVT
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episodes. These programs are tailored to meet the regulatory requirements in the territories in which the clinical sites are located.
Etripamil: Atrial Fibrillation with Rapid Ventricular Rate
As with PSVT, calcium channel blockers are also approved for use in intravenous form for the treatment of some episodes of atrial fibrillation in which patients experience rapid ventricular rates. We began enrollment in a Phase 2 proof-of-concept clinical trial, titled ReVeRA, in the first quarter of 2021 to evaluate the ability of etripamil to reduce ventricular rate in AFib-RVR episodes. The Phase 2 double blind, placebo controlled, proof-of-concept study is being conducted in Canada in collaboration with the Montreal Heart Institute and other research centers, and is expected to enroll approximately 50 patients randomized 1:1 to receive either 70 mg of etripamil nasal spray or placebo. The primary endpoint will assess reduction in ventricular rate, with key secondary endpoints including the time to achieve the maximum reduction in rate and the duration of the effect.The trial is being conducted in the hospital or emergency department setting under medical supervision. We anticipate reporting data from this study following disclosure of top line results of the RAPID trial.
Operations Overview
Since the commencement of our operations in 2003, we have devoted substantially all of our resources to performing research and development activities in support of our product development efforts, hiring personnel, raising capital to support and expand such activities, providing general and administrative support for these operations and, more recently preparing for commercialization. We operate our business using a significant outsourcing model. As such, our team is composed of a relatively smaller core of employees who direct a significantly larger number of team members who are outsourced in the forms of vendors and consultants to enable execution of our operational plans. We do not currently have any products approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations.
While we had net income of $0.8 million in the three months ended June 30, 2021, due to the receipt of a $15 million upfront payment under our License and Collaboration Agreement, or the License Agreement, with Ji Xing Pharmaceuticals, Limited, or Ji Xing, we have incurred significant operating losses since our inception, including a net loss of $11.7 million for the six months ended June 30, 2021. As of June 30, 2021, we had an accumulated deficit of $175.2 million. We expect to continue to incur significant losses for the foreseeable future. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the necessary development activities required for obtaining regulatory approval and preparing for potential commercialization of our product candidates. We had $135.8 million of cash, cash equivalents and short-term investments at June 30, 2021.
We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. Our net losses may fluctuate significantly from period to period, depending on the timing of our planned clinical trials and expenditures on other research and development activities, as well as completion of milestones related to the License Agreement. We expect our expenses will increase substantially over time as we:
| ● | continue our ongoing and planned development of etripamil, including our Phase 3 clinical trials of etripamil for the treatment of PSVT and our Phase 2 proof-of-concept clinical trial of etripamil for the treatment of AFib-RVR; |
| ● | seek marketing approvals for etripamil for the treatment of PSVT, AFib-RVR and other cardiovascular indications; |
| ● | establish a sales, marketing, manufacturing and distribution capability, either directly or indirectly through third parties, to commercialize etripamil or any future product candidate for which we may obtain marketing approval; |
18
| ● | build a portfolio of product candidates through development, or the acquisition or in-license of drugs, product candidates or technologies; |
| ● | initiate preclinical studies and clinical trials for etripamil for any additional indications we may pursue, including the clinical trials for the treatment of atrial fibrillation with rapid ventricular rate as well as other areas of unmet medical need, and for any additional product candidates that we may pursue in the future; |
| ● | maintain, protect and expand our intellectual property portfolio; |
| ● | hire additional clinical, regulatory and scientific personnel; |
| ● | add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; and |
| ● | incur additional legal, accounting, insurance and other expenses associated with operating as a public company. |
COVID-19 Business Update
The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on our business, financial condition, results of operations and growth prospects. Our global workforce is utilizing a hybrid remote and office based model and this adjustment may adversely impact our business (see below for discussion on Clinical Development impacts). In addition, working at home policies could increase cybersecurity risk and communication disruptions. Governments have also implemented and continually adjusted restrictions as the spread and severity of the COVID-19 virus has impacted their territories. We continue to closely monitor the COVID-19 situation as we evolve our business continuity plans and response strategy.
Clinical Development
With respect to clinical development, we have taken measures to maintain patient safety and trial continuity and to preserve study integrity. For our clinical development programs, we have experienced disruptions or delays in our ability to initiate trial sites and enroll and assess patients, and such disruptions or delays may continue. Since the filing of our Annual Report on Form 10-K, the COVID-19 pandemic continues to impact patient enrollment rates in our NODE-303 study. While COVID resurgences around the world impact different geographies and clinical sites to varying degrees and at different times, the NODE-303 average overall enrollment rate has stabilized over the first half of 2021. The COVID-19 pandemic has delayed the initiation of many proposed RAPID clinical trial sites as some health care institutions have prioritized their resources for pandemic related activities with some precluding the initiation of new clinical trials. It has also delayed the initiation of enrollment for our ReVeRA trial of etripamil for AFib-RVR due to closures of clinical sites. Given the uncertainty and differing and evolving restrictions applicable to clinical trial sites and participants, additional disruptions and delays are possible. We will continue to monitor the impact of COVID-19 on our planned clinical sites and patient enrollment activities. We could also see an impact on the ability to supply study drug, report trial results, or interact with regulators, ethics committees or other important agencies due to limitations in regulatory authority employee resources or otherwise. In addition, we rely on contract research organizations or other third parties to assist us with clinical trials, and we cannot guarantee that they will continue to perform their contractual duties in a timely and satisfactory manner as a result of the COVID-19 pandemic. If the COVID-19 pandemic continues and persists for an extended period of time, and if phased reopenings stall or are limited due to continued spread of COVID-19, including variants, we could experience further significant disruptions to our clinical development timelines, which would adversely affect our business, financial condition, results of operations and growth prospects.
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Corporate Development
On May 15, 2021, we entered into the License Agreement with Ji Xing Pharmaceuticals, Limited, or Ji Xing, which is an entity affiliated with RTW Investments, LP, or RTW, a beneficial owner of approximately 14% of our common shares. Under the Agreement, that we granted Ji Xing exclusive development and commercialization rights to any pharmaceutical product that uses a device to deliver our proprietary calcium channel blocker known as etripamil by nasal spray for all prophylactic and therapeutic uses in humans, or the Field, in the following territories: People’s Republic of China, including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan, or the Territory. Ji Xing will be responsible for development and regulatory activities in the Territory, and we will remain responsible for certain manufacturing activities in the Territory, subject to our and Ji Xing’s entry into a supply agreement as contemplated by the License Agreement.
We and Ji Xing have established a Joint Steering Committee to review and discuss the overall strategy for the development and commercialization of the licensed products in the Field in the Territory, provide a forum for the discussion and coordination of the activities under the License Agreement, direct and oversee the operation of other joint subcommittees established pursuant to the License Agreement, and perform such other functions as expressly set forth in the License Agreement or allocated to it by the parties’ written agreement.
We received an upfront cash payment of $15 million and in the future could receive up to $107.5 million in total development and sales milestone payments. In addition, we will receive tiered royalty payments ranging from a percentage in the low double digits to the high double digits of Net Sales (as defined in the License Agreement) of all products sold in the Territory.
We expect that our current operating plan and existing cash and cash equivalents and short-term investments will be sufficient to fund our operations and we do not envision any events or conditions that may cast substantial doubt on our ability to continue as a going concern for at least the next 12 months.
During the second quarter of 2021, we continued to focus our efforts on the development of etripamil PSVT program, and have expanded our development activities with respect to our etripamil AFib-RVR program. The collaboration and licensing agreement described above will allow us to further expand the etripamil PSVT program. Our operating plan may further change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, third-party funding, marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. Furthermore, the COVID-19 pandemic continues to evolve and has resulted in a significant disruption of global financial markets. It is not possible to reliably estimate the length and severity of this disruption. If the disruption persists and deepens, we could experience an inability to access additional capital, which could in the future negatively affect our operations.
Other Financial and Corporate Impacts
While we expect the COVID-19 pandemic to continue to affect our business operations and financial results, the extent of the impact on our clinical development and regulatory efforts, our corporate development objectives and the value of and market for our common shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, Canada, Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease.
Components of Results of Operations
Revenues
We have not generated any revenues from product sales to date and we do not expect to generate revenues from product sales in the near future. Our revenues for the current year are from the license and collaboration agreement with Ji Xing and are comprised of upfront payments. For additional information about our revenue recognition policy, see “Note 2— Summary of Significant Accounting Policies.”
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Research and Development Expenses
Research and development expenses consist primarily of salaries and fees paid to external service providers and also include personnel costs, including share-based compensation expense and other related compensation expenses. We expense research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, collaborators and third-party service providers.
To date, substantially all of our research and development expenses have been related to the preclinical and clinical development of etripamil. As we advance etripamil or other product candidates for other indications, we expect to allocate our direct external research and development costs across each of the indications or product candidates. Further, while we expect our research and development costs for the development of etripamil in atrial fibrillation with rapid ventricular rate to increase for initiation of the ReVeRA clinical trial as we continue to expand this trial, we expect our research and development expenses related to the development of etripamil for PSVT to remain a very large majority of our total research and development expenses.
We expect our research and development expenses to increase as we continue the development of etripamil and prepare to pursue regulatory approval. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming and is subject to uncertainties and delays, including as a result of the ongoing COVID-19 pandemic. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if at all.
We recognize the benefit of Canadian research and development tax credits as a reduction of research and development costs for fully refundable investment tax credits.
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General and Administrative Expenses
General and administrative expenses include personnel and related compensation costs, expenses for outside professional services, lease expense, insurance expense and other general administrative expenses. Personnel costs consist of salaries, bonuses, benefits, related payroll taxes and share-based compensation. Outside professional services consist of legal, accounting and audit services and other consulting fees.
We expect to continue to incur expenses as a public company, including expenses related to compliance with the rules and regulations of the Securities and Exchange Commission, or SEC, and those of any national securities exchange on which our securities are traded, additional insurance expenses, investor relations activities, and other administrative and professional services.
Commercial Expenses
Commercial expenses consist primarily of personnel and related compensation costs, market and health economic research, and market development activities for PSVT and, to a lesser extent, AFib-RVR. The focus of these expenses is three-fold: first, we want to leverage rigorous primary and secondary research to fully understand our target disease states from the perspective of the patient, healthcare provider, and payer; second, we want to understand and document the burden of disease posed by PSVT and AFib-RVR from an epidemiology, healthcare resource use, and cost perspective; and third, we want to engage our target patient, physician, and payer stakeholders with evidence-based and compliant educational materials that serve to increase the awareness and understanding of the impact of PSVT and AFib-RVR on patients and the overall healthcare system.
Starting approximately one year before we file our new drug application, or NDA with the FDA, we anticipate our commercial expenses will increase substantially as we invest in the infrastructure, personnel, and operational expenses required to launch our first product in the United States, if approved.
Interest Income
Interest income primarily consists of interest income from our cash equivalents and short-term investments.
Results of Operations
Comparison of the Three Months Ended June 30, 2021 and 2020
The following table summarizes our results of operations and changes:
Three months ended |
| ||||||||||||
June 30, | |||||||||||||
(in thousands) |
| 2021 |
| 2020 | $Change |
| % Change | ||||||
Collaboration revenue | $ | 15,000 | — | $ | 15,000 |
| 100.0% | ||||||
Operating expenses | |||||||||||||
Research and development, net of tax credits | $ | 9,427 | $ | 8,622 | $ | 805 |
| 9.3% | |||||
General and administrative |
| 3,018 |
| 2,956 |
| 62 |
| 2.1% | |||||
Commercial |
| 1,843 |
| 1,527 | 316 |
| 20.7% | ||||||
Total operating expenses |
| 14,288 |
| 13,105 |
| 1,183 |
| 9.0% | |||||
Income (Loss) from operations |
| 712 |
| (13,105) |
| 13,817 |
| (105.4)% | |||||
Interest income, net of bank charges |
| 58 |
| 126 |
| (68) |
| (54.0)% | |||||
Net income (loss) and comprehensive income (loss) | $ | 770 | $ | (12,979) | $ | 13,749 |
| (105.9)% | |||||
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Comparison of the Six Months Ended June 30, 2021 and 2020
The following table summarizes our results of operations and changes:
Six months ended |
| ||||||||||||
June 30, | |||||||||||||
(in thousands) |
| 2021 |
| 2020 | $Change |
| % Change | ||||||
Collaboration revenue | $ | 15,000 | — | $ | 15,000 |
| 100.0% | ||||||
Operating expenses | |||||||||||||
Research and development, net of tax credits | $ | 18,022 | $ | 20,493 | $ | (2,471) |
| (12.1)% | |||||
General and administrative |
| 5,651 |
| 5,659 |
| (8) |
| (0.1)% | |||||
Commercial |
| 3,209 |
| 3,710 |
| (501) |
| (13.5)% | |||||
Total operating expenses |
| 26,882 |
| 29,862 |
| (2,980) |
| (10.0)% | |||||
Income (Loss) from operations |
| (11,882) |
| (29,862) |
| 17,980 |
| (60.2)% | |||||
Interest income, net of bank charges |
| 138 | 540 |
| (402) |
| (74.4)% | ||||||
Net income (loss) and comprehensive income (loss) | $ | (11,744) | $ | (29,322) | $ | 17,578 |
| (60.0)% | |||||
Collaboration Revenue
We generated revenue of $15 million from upfront payments under the License Agreement during the three months and six months ended June 30, 2021.
Research and Development Expenses
The following table shows our research and development expenses by type of activity for the three and six months ended June 30, 2021 and 2020, respectively.
Three months ended June 30, | $ Change |
| % Change | Six months ended June 30, | $ Change |
| % Change | |||||||||||||||
(in thousands) |
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||||||||||||
Clinical | $ | 7,677 | $ | 6,911 | $ | 766 |
| 11.1% | $ | 14,466 | $ | 16,620 | $ | (2,154) |
| (13.0)% | ||||||
Drug manufacturing and formulation |
| 1,237 |
| 1,117 |
| 120 |
| 10.7% |
| 2,653 |
| 2,741 |
| (88) |
| (3.2)% | ||||||
Regulatory and other costs |
| 600 |
| 667 |
| (67) |
| (10.0)% |
| 1,081 |
| 1,310 |
| (229) |
| (17.5)% | ||||||
Less: investment tax credits |
| (87) |
| (73) |
| (14) |
| 19.2% |
| (178) |
| (178) |
| — |
| 0.0% | ||||||
Total R&D expenses | $ | 9,427 | $ | 8,622 | $ | 805 |
| 9.3% | $ | 18,022 | $ | 20,493 | $ | (2,471) |
| (12.1)% | ||||||
Research and development expenses increased by $0.8 million, or 9.3%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. The variance is mainly due to the increase in clinical expense of $0.8 million. Spending during both periods in 2021 and 2020 was primarily related to advancing our Phase 3 efficacy and safety trials in etripamil for the treatment of PSVT with the majority of the increase in the three months ended June 30, 2021 compared to the same period in 2020 related to clinical personnel related costs. The increase in clinical personnel cost is related to increased share-based compensation expense due to new grants to clinical employees in the three months ended June 30, 2021 at higher black-scholes valuations resulting from the increase in the Company’s stock price compared to prior periods.
Research and development expenses decreased by $2.5 million, or 12.1% for the six months ended June 30, 2021 compared to the six months ended June 30, 2020. The variance is mainly due to the decrease in clinical expense of $2.2 million. Spending during both periods in 2021 and 2020 was primarily related to advancing our Phase 3 efficacy and safety trials in etripamil for the treatment of PSVT with the majority of the decrease due to the fact that the first quarter of 2020 included additional costs related to the effort to complete the first part of the NODE-301 trial. The decrease in
23
clinical trial expense for the six months ended June 30, 2021 compared to the same period in 2020 was partially offset by an increase of $0.5 million in clinical personnel related costs, including non-cash compensation costs related to share-based compensation expense. The increase in clinical personnel cost is related to increased share-based compensation expense due to new grants to clinical employees in 2021 at higher black-scholes valuations resulting from the increase in the Company’s stock price compared to prior periods.
General and Administrative Expenses
General and administrative expenses were relatively stable and decreased by $62 thousand, or 2.1%, for the three months ended June 30, 2021 compared to the three months ended June 30, 2020. Similarly, general and administrative expenses were relatively stable and decreased by $8 thousand, or 0.1%, for the six months ended June 30, 2021 compared to the six months ended June 30, 2020.
Commercial Expenses
Commercial expenses increased by $0.3 million, or 20.7%, for the three months ended June 31, 2021 compared the same period in 2020. During the second quarter of 2020, we reduced commercial costs in order to focus our efforts on an optimized clinical development pathway for etripamil after we issued topline results of the first part of the NODE-301 in March 2020. During the three months ended June 30, 2021, we increased our investment in commercialization activities resulting in higher expenses when compared to the period in 2020.
Commercial expenses decreased by $0.5 million, or 13.5%, for the six months ended June 31, 2020, compared the same period in 2020. This decrease is mostly due to the fact that spending before we issued topline results of the first part of the NODE-301 in March 2020 was significantly higher compared to the same period in 2021.
Interest Income, Net
Interest income, net of bank charges, was $0.1 million for both the three-month periods ended June 30, 2021 and 2020. Interest income, net of bank charges, was $0.1 million and $0.5 million for the six-month periods ended June 30, 2021 and 2020, respectively. The reduction in interest income was due to lower interest rates earned on investments in 2021 when compared to 2020.
Net Income (Loss)
We had net income of $0.8 million and a net loss of $13.0 million for the three months ended June 30, 2021 and 2020, respectively. We had net losses of $11.7 and $29.3 million for the six months ended June 30, 2021 and 2020, respectively. The net income in the second quarter of 2021 and the decrease in net loss for the for the six months ended June 30, 2021 compared to the six months ended June 30, 2020 is due to the upfront payment received from the License Agreement, which was recognized as collaboration revenue.
Liquidity and Capital Resources
Sources of Liquidity
Except for the three months ended June 30, 2021, we have incurred operating losses and experienced negative operating cash flows since our inception, and we anticipate continuing to incur losses for at least the next several years. As of June 30, 2021, we had cash, cash equivalents and short-term investments of $135.8 million and an accumulated deficit of $176.0 million.
Pursuant to the License agreement, we received an upfront cash payment of $15 million (see note 3 of our unaudited interim condensed consolidated financial statement) during the three months ended June 30, 2021, and in the future could receive up to $107.5 million in total development and sales milestone payments. In addition, under the License Agreement, we will receive tiered royalty payments ranging from a percentage in the low double digits to the high double digits of Net Sales (as defined in the License Agreement) of all products sold in the Territory.
24
Pursuant to the License Agreement, we and affiliates of RTW, or the Purchasers, entered into a securities purchase agreement pursuant to which we issued to the Purchasers, in a private placement, pre-funded warrants to purchase up to an aggregate of 910,746 of our common shares at a purchase price of $5.48 per pre-funded warrant, or the Private Placement. The gross proceeds to us from the Private Placement, excluding proceeds from the exercise price of the warrants, were approximately $4.9 million.
On July 29, 2020, we entered into an Open Market Sale Agreement℠, or the Sales Agreement, with Jefferies LLC, or Jefferies, with respect to an at-the-market offering program, or the ATM Program, under which we may issue and sell our common shares having an aggregate offering price of up to $50 million through Jefferies as our sales agent or principal. The common shares to be sold under the Sales Agreement, if any, will be offered and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-239318), which was declared effective by the Securities and Exchange Commission on July 6, 2020. We have not sold shares under the ATM program as of the date of this filing.
We have evaluated whether material uncertainties exist relating to clinical trials, the COVID-19 pandemic and the impact on market conditions. The COVID-19 pandemic has had an impact on our business, operations and clinical development timelines. Government orders and restrictions in order to control the spread of the disease have impacted patient recruitment, enrollment and follow-up visits at clinical sites. At the date of the publication of our quarterly report, it is not possible to reliably estimate the length and severity of these developments. We expect that our current operating plan, existing cash, cash equivalents, short-term investments and access to financing sources to be sufficient to fund our operations and determined that there are no events or conditions that may cast substantial doubt on our ability to continue as a going concern for at least the next 12 months from the date of this filing. Based on our cash, cash equivalents and short-term-investments as of June 30, 2021, including the upfront payment from Ji Xing and proceeds from the equity investment from the Purchasers, we expect to be able to support our ongoing operations into mid-2023.
Funding Requirements
We use our cash primarily to fund research and development expenditures. We expect our research and development expenses to increase as we continue the development of etripamil and prepare to pursue regulatory approval. We expect to incur an increase in general and administrative expenses, and a continued increase in expenses related to commercial activities in 2021 as we focus our efforts on the clinical pathway and potential commercialization of etripamil. We expect to incur increasing operating losses for the foreseeable future as we continue the clinical development of our product candidate. At this time, due to the inherently unpredictable nature of clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize etripamil or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations.
In addition, we have exclusive development and commercialization rights for etripamil for all indications that we may pursue outside the Territory under the License Agreement, and as such have the potential to license development and or commercialization rights for etripamil to other potential partners. We plan to establish commercialization and marketing capabilities using a direct sales force to commercialize etripamil in the United States. Outside of the United States and the Territory, we are considering commercialization strategies that may include collaborations with other companies. In the case of either in-licensing or out-licensing, we cannot forecast when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development and commercialization plans and capital requirements.
The timing and amount of our operating expenditures will depend largely on:
| ● | the timing, progress and results of our ongoing and planned clinical trials and other development activities of etripamil in PSVT, AFib-RVR and other cardiovascular indications; |
| ● | the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials of etripamil for additional indications or any future product candidates that we may pursue; |
25
| ● | our ability to establish collaborations on favorable terms, if at all; |
| ● | the ability of vendors and third-party service providers to accurately forecast expenses and deliver on expectations; |
| ● | the costs, timing and outcome of regulatory review of etripamil and any future product candidates; |
| ● | the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for etripamil and any future product candidates for which we receive marketing approval; |
| ● | the revenue, if any, received from commercial sales of etripamil and any future product candidates for which we receive marketing approval; |
| ● | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and |
| ● | the extent to which we acquire or in-license other product candidates and technologies. |
Until such time, if ever, as we can generate substantial revenue from product sales, we expect to fund our operations and capital funding needs through equity and/or debt financing and existing collaborations. We may also consider entering into additional collaboration arrangements or selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our shareholders. The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items. In addition, the COVID-19 pandemic continues to rapidly evolve and has already resulted in a significant disruption of global financial markets. If the disruption persists and deepens, we could experience an inability to access additional capital, which could in the future negatively affect our operations. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
Six months ended |
| ||||||||||
June 30, | |||||||||||
(in thousands) | 2021 |
| 2020 |
| $ Change |
| % Change | ||||
Net cash (used in) provided by: | |||||||||||
Operating activities | $ | (11,455) | $ | (34,641) | 23,186 |
| (66.93) | % | |||
Investing activities | 32,000 | (32,000) | 64,000 |
| (200.00) | % | |||||
Financing activities | 4,939 | 249 | 4,690 |
| 1,883.53 | % | |||||
Net increase (decrease) in cash and cash equivalents during the period | $ | 25,484 |
| $ | (66,392) | 91,876 |
|
| |||
Operating Activities
In the six months ended June 30, 2021, we used $11.5 million of cash in operating activities, which consisted of a net loss of $11.7 million and a net change of $3.0 million in our net operating liabilities and non-cash charges of $3.3 million related to share-based compensation expense for grants to employees, board directors and consultants. The change in our net operating assets and liabilities was mainly due to a decrease of $0.8 million for accounts payable and accrued liabilities and an increase of $2.0 million for prepaid expenses.
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In the six months ended June 30, 2020, we used $34.6 million of cash in operating activities, which consisted of a net loss of $29.3 million and a net change of $7.5 million in our net operating liabilities and non-cash charges of $2.2 million related to share-based compensation expense for grants to employees, board directors and consultants. The change in our net operating assets and liabilities was mainly due to a decrease of $3.2 million for accounts payable and accrued liabilities and a increase of $4.2 million for prepaid expenses.
Investing Activities
In the six months ended June 30, 2021, we received $32.0 million of cash for the redemption of short-term investments compared to the same period in 2020 where we used $32.0 million of cash for the acquisition of short-term investments.
Financing Activities
In the six months ended June 30, 2021, our financing activities provided $4.9 million, consisting of net proceeds from the Private Placement and a de minimis amount of proceeds from the exercise of share options. In the six months ended June 30, 2020, our financing activities provided $249 thousand, which consisted of proceeds from the exercise of share options.
We have not entered into off-balance sheet arrangements.
Contractual Obligations
During the six months ended June 30, 2021, there were no material changes to our contractual obligations and commitments described under "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K, filed with the SEC on March 29, 2021.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited interim consolidated financial statements as of June 30, 2021, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP and on a basis consistent with those accounting principles followed by us and disclosed in Note 2 to our most recent annual audited consolidated financial statements.
The preparation of these unaudited interim condensed consolidated financial statements requires our management to make judgments and estimates that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Significant estimates and judgments include, but are not limited to, research and development tax credits recoverable, research and development expenses, and share-based compensation. Accordingly, actual results may differ from these judgments and estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
We anticipate that the COVID-19 pandemic will have an impact on the development timelines of our clinical programs. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, we are not aware of any specific event or circumstance that would require the update of our estimates, assumptions and judgments. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to our financial statements.
27
Other than as described under Note 2 of our unaudited interim condensed consolidated financial statements, there have been no material changes to our significant accounting policies from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our most recent annual consolidated financial statements.
Recent Accounting Pronouncements
Refer to Note 2, “Summary of Significant Accounting Policies”, for a discussion of recent accounting pronouncements and to the notes to our audited consolidated financial statements as of December 31, 2020 appearing in our Annual Report on Form 10-K, filed with the SEC on March 29, 2021.
Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The primary objective of our investment activities is to preserve principal and liquidity while maximizing income without significantly increasing risk. We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest rate risks. We had cash, cash equivalents and short-term investments of $135.8 million as of June 30, 2021, which consist primarily of bank deposits and guaranteed investment certificates. We do not enter into investments for trading or speculative purposes. Due to the short-term nature of our investment portfolio, we do not believe an immediate 10% increase or decrease in interest rates would have a material effect on the fair market value of our portfolio, and accordingly we do not expect our operating results or cash flows to be materially affected by a sudden change in market interest rates.
We undertake certain transactions in Canadian dollars and as such are subject to risk due to fluctuations in exchange rates. Canadian dollar denominated payables are paid at the converted rate as due. We do not use derivative instruments to hedge exposure to foreign exchange rate risk due to the low volume of transactions denominated in foreign currencies. On June 30, 2021, our net monetary exposure denominated in Canadian dollars was $0.9 million.
Our operating results and financial position are reported in U.S. dollars in our consolidated financial statements. The fluctuation of the Canadian dollar in relation to the U.S. dollar might, consequently, have an impact upon our loss and may also affect the value of our assets and the amount of shareholders’ equity.
We do not believe that inflation and changing prices had a significant impact on our results of operations for any periods presented herein. We do not have a formal hedging program with respect to foreign currency. A 10% increase or decrease in current exchange rates would not have a material effect on our consolidated financial results.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed
28
and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2021. Based upon the evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.
Changes in Internal Control over Financial Reporting.
There were no changes in our internal control over financial reporting during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We have not experienced any material impact to our internal controls over financial reporting despite the fact that our employees have worked remotely due to the COVID-19 pandemic. We are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact on their design and operating effectiveness.
Inherent Limitations on Effectiveness of Controls.
Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.
Item 1A. Risk Factors
There have been no material changes from the risk factors previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K, filed with the SEC on March 29, 2021.
29
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent Sales of Unregistered Equity Securities
None
Use of Proceeds from the IPO
On May 13, 2019, we completed the IPO and issued 6,325,000 common shares at an initial offering price of $15.00 per share (inclusive of 825,000 common shares pursuant to the full exercise of an overallotment option granted to the underwriters in connection with the offering). We received net proceeds from the IPO of $85.4 million, after deducting underwriting discounts and commissions. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to their associates. Jefferies LLC, Cowen and Company, LLC and Piper Jaffray & Co. acted as lead book-running managers. Oppenheimer & Co. Inc. acted as lead manager for the IPO.
Our common shares began trading on The Nasdaq Global Select Market on May 9, 2019. The offer and sale of the shares were registered under the Securities Act on Registration Statement on Form S-1 (Registration No. 333-230846), which was declared effective on May 8, 2019.
There has been no material change in the planned use of proceeds from the IPO as described in the prospectus used in connection therewith. We invested the funds received in cash equivalents and other short-term investments in accordance with our investment policy. In July 2020, we started to use proceeds from the IPO for the development of etripamil and to pursue regulatory approval.
Item 3. Defaults Upon Senior Securities.
Not applicable
Item 4. Mine Safety Disclosures.
Not applicable
Item 5. Other Information.
Not applicable
30
Item 6. Exhibits.
| ||
Exhibit |
| Description |
3.1 | ||
3.2 | ||
4.1 | ||
10.1+ | ||
31.1 |
| |
31.2 |
| |
32.1* |
| |
101.INS | Inline XBRL Instance Document | |
101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, formatted in Inline XBRL. |
* Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
+ | Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K. The Registrant hereby undertakes to furnish to the SEC, upon request, copies of any such instruments. |
31
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
MILESTONE PHARMACEUTICALS INC. | ||
Date: August 11, 2021 | By: | /s/ Joseph Oliveto |
Joseph Oliveto | ||
President and Chief Executive Officer | ||
Date: August 11, 2021 | By: | /s/ Amit Hasija |
Amit Hasija | ||
Chief Financial Officer | ||
32
Exhibit 4.1
NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS. THIS SECURITY AND THE SECURITIES ISSUABLE UPON EXERCISE OF THIS SECURITY MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN SECURED BY SUCH SECURITIES.
UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE SEPTEMBER [●], 2021.
MILESTONE PHARMACEUTICALS INC.
FORM OF PRE-FUNDED WARRANT TO PURCHASE COMMON SHARES
Number of Shares: [●] (subject to adjustment)
Warrant No. PFW2021 - [ ] | Original Issue Date: May [●], 2021 |
Milestone Pharmaceuticals Inc., an exempted company incorporated and existing under the laws of the Province of Québec, Canada (the “Company”), hereby certifies that, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, [] or its registered assigns (the “Holder”), is entitled, subject to the terms set forth below, to purchase from the Company up to a total of [●] common shares, no par value per share (the “Common Shares”), of the Company (each such share, a “Warrant Share” and all such shares, the “Warrant Shares”) at an exercise price per share equal to $0.01 per share (as adjusted from time to time as provided in Section 9 herein, the “Exercise Price”) upon surrender of this Warrant to Purchase Common Shares (including any Warrants to Purchase Common Shares issued in exchange, transfer or replacement hereof, the “Warrant”) at any time and from time to time on or after the date hereof (the “Original Issue Date”) until the Warrant has been exercised in full, subject to the following terms and conditions:
| 1. | Definitions. For purposes of this Warrant, the following terms shall have the following meanings: |
| (b) | “Commission” means the United States Securities and Exchange Commission. |
| (e) | “Securities Act” means the Securities Act of 1933, as amended. |
| 4. | Exercise and Duration of Warrants. |
| 5. | Delivery of Warrant Shares. |
the Company’s share register, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise by the date that is two (2) Trading Days after the delivery to the Company of the Notice of Exercise and delivery of the aggregate Exercise Price (if applicable) to the Company. The Holder, or any natural person or legal entity (each, a “Person”) so designated by the Holder to receive Warrant Shares, shall be deemed to have become the holder of record of such Warrant Shares as of the Exercise Date, irrespective of the date such Warrant Shares are credited to the Holder’s DTC account or the date of restricted book-entry evidencing such Warrant Shares, as the case may be.
| 9. | Certain Adjustments. The Exercise Price and number of Warrant Shares issuable upon exercise of this Warrant are |
subject to adjustment from time to time as set forth in this Section 9.
Company shall not effect any Fundamental Transaction in which the Company is not the surviving entity or the Alternate Consideration includes securities of another Person unless (i) the Alternate Consideration is solely cash and the Company provides for the simultaneous “cashless exercise” of this Warrant pursuant to Section 10 below or (ii) prior to or simultaneously with the consummation thereof, any successor to the Company, surviving entity or other Person (including any purchaser of assets of the Company) shall assume the obligation to deliver to the Holder such Alternate Consideration as, in accordance with the foregoing provisions, the Holder may be entitled to receive, and the other obligations under this Warrant. The provisions of this paragraph (c) shall similarly apply to subsequent transactions analogous of a Fundamental Transaction type.
X = Y [(A-B)/A]
where:
“X” equals the number of Warrant Shares to be issued to the Holder;
“Y” equals the total number of Warrant Shares with respect to which this Warrant is then being exercised;
“A” equals the Closing Sale Price per Common Share as of the Trading Day on the date immediately preceding the Exercise Date; and
“B” equals the Exercise Price per Warrant Share then in effect on the Exercise Date.
For purposes of Rule 144 promulgated under the Securities Act, it is intended, understood and acknowledged that the Warrant Shares issued in such a “cashless exercise” transaction pursuant to Section 9(c) hereof shall be deemed to have been acquired by the Holder, and the holding period for the Warrant Shares shall be deemed to have commenced, on the date this Warrant was originally issued (provided that the Commission continues to take the position that such treatment is proper at the time of such exercise).
For the avoidance of doubt, any exercise of this Warrant pursuant to Section 4 hereof shall only be settled in cash.
| 11. | Limitations on Exercise. |
on the Closing Sale Price) for any such fractional shares.
If to the Company:
Attention: Amit Hasija, Chief Financial Officer Milestone Pharmaceuticals Inc.
1111 Dr. Frederik-Philips Blvd., Suite 420 Montréal, Québec H4M 2X6
Email: ahasija@milestonepharma.com
with copies (which shall not constitute notice) to:
Attention: Ryan Sansom Cooley LLP
500 Boylston Street, 14th Floor Boston, Massachusetts 02116
Facsimile: (617) 937-2400 Email: rsansom@cooley.com
If to the Holder, to its address or e-mail address set forth herein or on the books and records of the Company.
Or, in each of the above instances, to such other address or e-mail address as the recipient party has specified by written notice given to each other party at least five (5) days prior to the effectiveness of such change.
| 15. | Miscellaneous. |
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the Company has caused this Warrant to be duly executed by its authorized officer as of the date first indicated above.
MILESTONE PHARMACEUTICALS INC. | |
By: | |
Name: | Joseph G. Oliveto |
Title: | President and CEO |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
Exhibit 10.1
LICENSE AND COLLABORATION AGREEMENT
This License and Collaboration Agreement (this “Agreement”) is entered into as of May 15, 2021 (the “Effective Date”) by and between:
Milestone Pharmaceuticals, Inc., a Quebec corporation with a place of business at 1111 Dr.-Frederik-Philips Blvd., Ste. 420, Montreal, (Quebec), H4M 2X6 Canada (“MIST”), and
Ji Xing Pharmaceuticals Limited, a limited liability company organized and existing under the laws of Hong Kong, with a business address located at Room 1902, 19/F, Lee Garden One, 33 Hysan Avenue, causeway Bay, Hong Kong Special Administrative Region (“Ji Xing”).
MIST and Ji Xing are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
Whereas, MIST, a biopharmaceutical company, is developing etripamil, a novel calcium channel blocker in the form of a nasal spray, for the acute treatment of patients with Paroxysmal Supraventricular Tachycardia and other episodic cardiovascular conditions;
Whereas, Ji Xing is a pharmaceutical company organized to develop and commercialize pharmaceutical products in the greater China region; and
Whereas, Ji Xing wishes to obtain an exclusive license from MIST to develop, import and commercialize such product in the Territory, and MIST is willing to grant such a license and to supply such product to Ji Xing for development and commercial use in the Territory, all in accordance with the terms and conditions set forth herein.
Agreement
Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
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Each of the amounts set forth above shall be determined from the books and records of Ji Xing, its Affiliate or sublicensee, maintained in accordance with GAAP consistently applied. For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (a)-(f) above, such item may not be deducted more than once.
With respect to any sale of the Product [*].
Sales between Ji Xing and its Affiliates and sublicensees shall be disregarded for purposes of calculating Net Sales except if such purchaser is an end user. Net Sales also exclude any sale or transfer of the Product for free or below cost in early access, compassionate use or named patient programs.
Notwithstanding the foregoing, Net Sales shall not include amounts (whether actually existing or deemed to exist for purposes of calculation) for Product distributed for use in Clinical Trials.
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Defined Terms | Section |
|---|---|
Agreed Percentage | Section 8.9(b) |
Agreement | Preamble |
Alliance Manager | Section 3.1 |
Assigning Party | Section 8.9(c) |
Commercialization Plan | Section 7.3 |
Competing Product | Section 2.7(b) |
Development Plan | Section 4.3 |
Effective Date | Preamble |
Executive Officers | Section 3.2 |
FCPA | Section 15.7(a) |
FCPA Covered Person | Section 15.7(a) |
ICC | Section 14.3(a) |
Incremental Taxes | Section 8.9(c) |
Indemnified Party | Section 12.3 |
Indemnifying Party | Section 12.3 |
Initiation | Section 8.3(b)(iii) |
JCC | Section 3.4 |
JDC | Section 3.3 |
Ji Xing | Preamble |
Ji Xing Indemnitee(s) | Section 12.2 |
Joint Commercialization Committee | Section 3.4 |
Joint Development Committee | Section 3.3 |
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Defined Terms | Section |
|---|---|
Joint Steering Committee | Section 3.2 |
JSC | Section 3.2 |
Losses | Section 12.1 |
MIST | Preamble |
MIST Indemnitee(s) | Section 12.1 |
MIST Trademarks | Section 9.6(b) |
Non-Compete Period | Section 2.6 |
Other Product | Section 2.7(a) |
Parties | Preamble |
Party | Preamble |
Pharmacovigilance Agreement | Section 5.6 |
Phase 1 Waiver | Section 8.3(a) |
Phase 3 Waiver | Section 8.3(a) |
Prior CDA | Section 10.6 |
Product Infringement | Section 9.3(b) |
Product Marks | Section 9.6(a) |
Region | Section 1.52 |
Remedial Action | Section 5.9 |
ROFN | Section 2.7(b) |
Royalty Term | Section 8.5(b) |
[*] | [*] |
SEC | Section 10.5(b) |
Successful completion | Section 8.3(b)(iii) |
Supply Agreement | Section 6.1 |
Technology Transfer Plan | Section 4.4(a) |
Term | Section 13.1(a) |
Upstream Licensor | Section 1.55 |
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For clarity, the foregoing license does not include any right for Ji Xing to Manufacture the Compound (except with MIST’s written consent and in accordance with Section 2.1(c)) or Device, or Develop, use, import, sell, offer for sale and otherwise Commercialize a generic version of the Product.
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Development Milestone Event | Milestone Payment |
1) [*] | [*] |
2) [*] | [*] |
3) [*] | [*] |
4) [*] | [*] |
5) [*] | [*] |
6) [*] | [*] |
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7) [*] | [*] |
Total | $[*] |
Aggregate annual Net Sale of all Products in the Territory | Milestone Payment |
1. [*] | [*] |
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2. [*] | [*] |
3. [*] | [*] |
4. [*] | [*] |
5. [*] | [*] |
6. [*] | [*] |
Total | [*] |
For that portion of annual Net Sale of the Product in the Territory | Royalty Rate |
1) less than or equal to [*] | [*] |
2) greater than [*] but less than or equal to [*] | [*] |
3) greater than [*] but less than or equal to [*] | [*] |
4) greater than [*] but less than or equal to [*] | [*] |
5) greater than [*] | [*] |
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
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CONFIDENTIALITY
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except in each case to the extent such Losses arise out of the negligence, willful misconduct or breach of this Agreement by any MIST Indemnitee or arise from, are based on, or result from any activity or occurrence for which MIST is obligated to indemnify Ji Xing under Section 12.2.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
except in each case to the extent such Losses arise out of the negligence, willful misconduct or breach of this Agreement by any Ji Xing Indemnitee or arise from, are based on, or result from any activity or occurrence for which Ji Xing is obligated to indemnify MIST under Section 12.1.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
The definition of Net Sales and Sections 8.5 through 8.8 (excluding 8.5(a) and 8.5(b)) shall apply mutatis mutandis with respect to the sale of the Product by or on behalf of MIST in the Territory.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
MISCELLANEOUS
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If to MIST:
Milestone Pharmaceuticals, Inc.
7422 Carmel Executive Drive, Suite 300
Charlotte, NC 28226
Attn: [*]
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
with a copy to:
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304, USA
Attn:[*]
Fax:[*]
If to Ji Xing:
Ji Xing Pharmaceuticals Limited
c/o RTW Investments, LP
40 10th Avenue, 7th Floor
New York, NY 10014
Attn: [*]
Email:[*]
with a copy to:
Ropes & Gray LLP
36/F, Park Place
1601 Nanjing Road West
Shanghai, The People’s Republic of China
Attn: [*]
Email: [Geoffrey.Lin@ropesgray.com]
Fax: [*]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given (a) when delivered if personally delivered or sent by facsimile on a Business Day; (b) on the second Business Day after dispatch if sent by internationally-recognized overnight courier; or (c) on the fifth Business Day following the date of mailing if sent by mail.
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{Signature Page Follows}
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In Witness Whereof, the Parties intending to be bound have caused this License and Collaboration Agreement to be executed by their duly authorized representatives as of the Effective Date.
Milestone Pharmaceuticals, Inc. | Ji Xing Pharmaceuticals Limited |
By: By:
Name: Name:
Title: Title:
Date: Date:
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
List of Exhibits
Exhibit A:Compound and Device
Exhibit B:Existing Licensed Patents
Exhibit C:Initial Development Plan
Exhibit D:Technology Transfer Plan
Exhibit E:Securities Purchase Agreement
Exhibit F:Joint Press Release
Schedule 2.8:Approved Subcontractors
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Exhibit B
Existing Licensed Patents
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Exhibit C
Initial Development Plan
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Exhibit D
Technology Transfer Plan
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Exhibit E
Securities Purchase Agreement
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Exhibit F
Press Release
Milestone Pharmaceuticals Announces Exclusive License Agreement with Ji Xing Pharmaceuticals to Develop and Commercialize Etripamil for PSVT in Greater China
- Ji Xing Pharmaceuticals to develop and commercialize etripamil for patients with PSVT in Greater China -
- Milestone to receive a $15 million upfront cash payment and a $5 million equity investment by RTW Investments, LP -
Montreal and Charlotte, N.C., May 17, 2021 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced an exclusive license and collaboration agreement with Ji Xing Pharmaceuticals (Ji Xing) to develop and, if approved, commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China. Ji Xing is a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW) focused on advancing innovative medicines in China.
“This agreement marks an important step toward realizing our vision for etripamil to benefit patients living with PSVT globally while strengthening our balance sheet and executional capabilities through partnership,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We look forward to partnering with the talented team at Ji Xing to develop and commercialize this promising therapy in the licensed regions.”
“Etripamil has the potential to change the treatment paradigm for PSVT and could serve as a meaningful new therapeutic option for patients,” said Peter Fong, Chief Executive Officer of Ji Xing and Head of Company Creation at RTW. “We are delighted to expand Ji Xing’s cardiovascular focus by partnering with Milestone and look forward to unlocking the full therapeutic potential of etripamil for patients with PSVT in China.”
Under the terms of the agreement, Milestone will grant Ji Xing an exclusive license to develop and, if regulatory approval is obtained, commercialize etripamil in patients with PSVT in Greater China. Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. Milestone will supply etripamil and delivery devices to Ji Xing. Ji Xing will be responsible for development and commercialization costs in Greater China.
About Paroxysmal Supraventricular Tachycardia
Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning that affects approximately two million Americans. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.
About Etripamil
Etripamil, Milestone's lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and a Phase 2 proof-of-concept trial is now underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).
About Ji Xing Pharmaceuticals
Backed by RTW Investments, LP, Ji Xing is a privately held, leading biotechnology company headquartered in Shanghai committed to bringing innovative science and medicines to underserved Chinese patients with serious and life-threatening diseases.
About RTW Investments
RTW Investments, LP (“RTW”) is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and/or academics developing them.
For further information about RTW, please visit www.RTWfunds.com.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq: MIST), is a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Milestone’s lead product candidate etripamil is currently in a Phase 3 clinical-stage program for the treatment of paroxysmal supraventricular tachycardia (PSVT) and in a Phase 2 proof-of-concept trial for the treatment of patients with atrial fibrillation and rapid ventricular rate (AFib-RVR). Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow the Company on Twitter at @MilestonePharma.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," “potential,” "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential of etripamil as a promising therapy for PSVT
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
patients, and Milestone’s and Ji Xing’s intention and ability to develop and commercialize etripamil in China. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process, uncertainties related to the timing of initiation, enrollment, completion and evaluation of clinical trials, and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, as well as risks related to pandemics and public health emergencies, including those related to COVID-19, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital. These and other risks are set forth in Milestone's filings with the U.S. Securities and Exchange Commission, including in its quarterly report on Form 10-K for the year ended December 31, 2020, under the caption "Risk Factors." Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Contact:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Schedule 2.8
Approved Subcontractors
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Oliveto, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Milestone Pharmaceuticals Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 11, 2021 | |
| /s/ Joseph Oliveto |
| Joseph Oliveto |
| President and Chief Executive Officer |
| (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Amit Hasija, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Milestone Pharmaceuticals Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 11, 2021 | |
| /s/ Amit Hasija |
| Amit Hasija |
| Chief Financial Officer |
| (Principal Financial Officer and Principal Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Joseph Oliveto, Chief Executive Officer of Milestone Pharmaceuticals Inc. (the “Company”), and Amit Hasija, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2021, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: August 11, 2021 |
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/s/ Joseph Oliveto | | /s/ Amit Hasija |
Joseph Oliveto | | Amit Hasija |
Chief Executive Officer | | Chief Financial Officer |
(Principal Executive Officer) | | (Principal Financial Officer and Principal Accounting Officer) |