QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
Title of each class |
Trading S ym bol |
Name of each exchange on which registered | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
• |
We are a clinical-stage biopharmaceutical company with a very limited operating history. We have incurred net losses since our inception and anticipate that we will continue to incur substantial and increasing net losses in the foreseeable future. We may never achieve or sustain profitability. |
• |
A pandemic, epidemic, or outbreak of an infectious disease, such as the global novel coronavirus disease 2019 (“COVID-19”) pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third-parties on whom we rely, our supply chain, our ability to raise capital, and our financial results. |
• |
We have never generated any revenue from product sales, and our ability to generate revenue from product sales and become profitable will depend significantly on our success in achieving a number of goals and on other factors. |
• |
We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our research, product development or commercialization efforts. |
• |
We are heavily dependent on the success of vidutolimod (formerly CMP-001), our only current product candidate. |
• |
We will not be able to commercialize vidutolimod and future product candidates if our preclinical studies do not produce successful results and our clinical trials do not demonstrate the safety and efficacy of vidutolimod and future product candidates. |
• |
Vidutolimod is based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development. |
• |
Difficulty in enrolling patients could delay or prevent clinical trials of vidutolimod and future product candidates. We may find it difficult to enroll patients in our clinical trials or any subsequent trials that we may conduct. |
• |
Vidutolimod is being, and future product candidates may be, evaluated in combination with third-party drugs, and we do not have control over the supply, regulatory status, or regulatory approval of such drugs. |
• |
We currently rely on third-party contract manufacturing organizations (“CMOs”) for the production of clinical supply of vidutolimod and may rely on CMOs for the production of commercial supply of vidutolimod, if approved. This reliance on CMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts. |
• |
We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, we may be unable to obtain regulatory approval for vidutolimod or any future product candidates or any approvals that may be obtained may be delayed. |
• |
Our collaboration agreements with any future third-parties may not be successful, which could adversely affect our ability to develop and commercialize vidutolimod or any future product candidates. |
• |
The regulatory approval processes of the U.S. Food and Drug Administration (the “FDA”) and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize vidutolimod and future product candidates as expected, and our ability to generate revenue may be materially impaired or eliminated. |
• |
Our relationships with patients and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings. |
• |
We face significant competition, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If competitive product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated. |
• |
If we are unable to obtain, maintain and protect our intellectual property rights for our technology and our product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed. |
• |
Our success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel. |
• |
our current expectations and anticipated results of operations; |
• |
the timing and the success of preclinical studies and clinical trials of vidutolimod and future product candidates, including our current Phase 2 trial for anti-PD-1 |
• |
the initiation and completion of any clinical trials of vidutolimod and future product candidates; |
• |
the ongoing impact of the COVID-19 pandemic on our business; |
• |
our need to raise additional funding before we can expect to generate any revenues from product sales and our ability to raise capital, including in light of the impact of the COVID-19 global pandemic and the related potential impact on the US and global economies; |
• |
our ability to conduct successful clinical trials or obtain regulatory approval for vidutolimod or any future product candidates that we may identify or develop; |
• |
our ability to ensure adequate supply of vidutolimod and any future candidates; |
• |
our ability to maintain third-party relationships necessary to conduct our business; |
• |
our dependence upon the success of our research to generate and advance additional product candidates; |
• |
our ability to establish an adequate safety and efficacy profile for vidutolimod or any future product candidates that we may pursue; |
• |
the implementation of our strategic plans for our business, vidutolimod and any other product candidates we may develop and our technology; |
• |
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
• |
the rate and degree of market acceptance and clinical utility for vidutolimod and any other product candidates we may develop; |
• |
our estimates about the size of our market opportunity; |
• |
our ability to maintain and establish collaborations and strategic relationships, including our clinical trial collaborations with an affiliate of Merck KGaA (“Merck”), Pfizer Inc. (“Pfizer”), Bristol-Myers Squibb Company (“BMS”), and Regeneron Pharmaceuticals, Inc. (“Regeneron”); |
• |
the potential benefits of the continued research, development, testing and manufacturing services provided by contract manufacturing organizations; |
• |
our financial performance and liquidity; |
• |
our ability to effectively manage our anticipated growth; |
• |
developments relating to our competitors and our industry, including the impact of government regulation; |
• |
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; |
• |
our ability to maintain adequate internal controls over financial reporting; |
• |
our expectations regarding the period during which we qualify as an “emerging growth company” under the Jumpstart Our Business Startups Act (the “JOBS Act”); |
• |
our expectations regarding the period during which we qualify as a “smaller reporting company”; |
• |
our use of proceeds from our initial public offering and our expectations regarding our estimated expenses, the sufficiency of our cash resources, our expected cash runway and our need for additional financing, and |
• |
other risks and uncertainties, including those listed under the section titled “Risk Factors.” |
5 | ||||||
Item 1. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
76 | |||||
77 |
June 30, 2021 |
December 31, 2020 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
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Short-term investments |
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Prepaid expenses and other current assets |
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Total current assets |
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Investments, non-current |
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Machinery and equipment, net |
— | |||||||
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Total assets |
$ | $ | ||||||
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Liabilities and Stockholders’ Equity |
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Current Liabilities: |
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Accounts payable |
$ | $ | ||||||
Accrued expenses |
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Total current liabilities |
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Total liabilities |
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Commitments and Contingencies (Note 9) |
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Stockholders’ Equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive gain (loss) |
( |
) | ( |
) | ||||
Accumulated deficit |
( |
) | ( |
) | ||||
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ |
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2021 |
2020 |
2021 |
2020 |
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Operating expenses: |
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Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
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Total operating expenses |
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Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
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Other income (expense), net: |
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Interest income |
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Loss on sale of available-for-sale |
( |
) | — | ( |
) | — | ||||||||||
Change in fair value of convertible loan notes |
— | ( |
) | — | ( |
) | ||||||||||
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Total other income (expense), net |
( |
) | ( |
) | ( |
) | ||||||||||
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Reconciliation of net loss attributable to common stockholders: |
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Accretion of issuance costs on redeemable convertible preferred stock |
— | ( |
) | — | ( |
) | ||||||||||
Accrued dividends on redeemable convertible preferred stock |
— | ( |
) | — | ( |
) | ||||||||||
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|
|
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Net loss attributable to common stockholders |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Weighted-average common shares outstanding—basic and diluted |
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Net loss per share attributable to common stockholders—basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Comprehensive loss: |
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Net los s |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Unrealized gain on available-for-sale investments |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
Comprehensive loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
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|
Series A Redeemable Convertible Preferred Stock |
Series B Redeemable Convertible Preferred Stock |
Series C Redeemable Convertible Preferred Stock |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Gain/(Loss) |
Total Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||||||||||
Balances at December 31, 2020 |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
||||||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Unrealized losses on available-for-sale investments |
— | — | — | — | — | — | — | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||||||||
Balances at March 31, 2021 |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||||||||
Exercise of stock options |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Unrealized gains on available-for- sale investments |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||||||||
Balances at June 30, 2021 |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
||||||||||||||||||||||||||||||
Series A Redeemable Convertible Preferred Stock |
Series B Redeemable Convertible Preferred Stock |
Series C Redeemable Convertible Preferred Stock |
Common Stock |
Additional Paid - In |
Accumulated |
Accumulated Other Comprehensive |
Total Stockholders’ |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Capital |
Deficit |
Gain/(Loss) |
Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||
Balances 31, 2019 |
$ |
$ |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
— |
$ |
( |
) | ||||||||||||||||||||||||||||||||
Issuance of series B redeemable convertible preferred $ per $net of issuance costs of |
— | — | — | — | — |
— | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Exercise of series B preferred stock tranche right |
— | — | — | — | — | — |
— | — | — | — | — | |||||||||||||||||||||||||||||||||||||
Accretion of issuance costs related to redeemable convertible preferred stock |
— | — | — | — | — | — |
— | — | ( |
) | — | ( |
) | |||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — |
— | |
— | — | |||||||||||||||||||||||||||||||||||||
Accrued dividends on redeemable convertible preferred stock |
— | — | — | — | — |
— | ( |
) | ( |
) | — | ( |
) | |||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — |
— | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||||||||
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Balances at March 31, 2020 |
— |
— |
— |
( |
) |
— | ( |
) | ||||||||||||||||||||||||||||||||||||||||
I ssuance of series C redeemable convertible preferred stock at$ per $net of issuance costs of |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Conversion of convertible notes into series C convertible redeemable preferred stock |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Accretion of issuance costs related to redeemable convertible preferred stock |
— | — | — | — | — | — | — |
— | ( |
) | — | ( |
) | |||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||
Accrued dividends on redeemable convertible preferred stock |
— | — | — | — | — | ( |
) | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||||||||
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|||||||||||||||||||||||||
Balances at June 30, 2020 |
$ |
$ |
$ |
$ |
$ |
— |
$ |
( |
) |
$ |
— |
$ |
( |
) | ||||||||||||||||||||||||||||||||||
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Six Months Ended June 30, |
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Stock based compensation |
||||||||
Depreciation |
— | |||||||
Change in fair value of notes payable |
— | |||||||
Amortization/accretion of investments |
— | |||||||
Change in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ||||||
Accounts payable |
( |
) | ( |
) | ||||
Accrued expenses |
( |
) | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash flows from investing activities |
||||||||
Purchases of investments |
( |
) | — | |||||
Maturities of investments |
— | |||||||
Sale of investments |
— | |||||||
Purchase of machinery and equipment |
( |
) | — | |||||
|
|
|
|
|||||
Net cash provided by investing activities |
— | |||||||
Cash flows from financing activities |
||||||||
Proceeds from stock option exercises |
— | |||||||
Cash paid for initial public offering costs |
— | ( |
) | |||||
Proceeds from issuance of convertible preferred stock, net of issuance costs |
— | |||||||
Proceeds from issuance of convertible loan notes |
— | |||||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
|
|
|
|
|||||
Net increase in cash, cash equivalents and restricted cash |
||||||||
Cash, cash equivalents and restricted cash at beginning of period |
||||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash at end of period |
$ | $ | ||||||
|
|
|
|
|||||
Supplemental disclosure of non-cash financing activities: |
||||||||
Accretion of issuance costs to redeemable convertible preferred stock |
$ | — | $ | |||||
Exercise of Series B preferred stock tranche right |
$ | — | $ | |||||
Accrued dividends on redeemable convertible preferred stock |
$ | — | $ | |||||
Conversion of loan notes into series C preferred stock |
$ | — | $ | |||||
Deferred offering costs included in prepaid expenses and other current assets and accounts payable or accrued |
$ | — | $ |
Amortized Cost |
Unrealized Gains |
Unrealized Losses |
Fair Value |
Short-term Investments |
Investments, non-current |
|||||||||||||||||||
(in thousands) |
||||||||||||||||||||||||
Commercial paper |
$ | $ | |
$ | — | $ | $ | $ | — | |||||||||||||||
Corporate debt securities |
( |
) | ||||||||||||||||||||||
Total |
$ | |
$ | $ | ( |
) | $ | $ | |
$ | |
|||||||||||||
Amortized Cost |
Unrealized Gains |
Unrealized Losses |
Fair Value |
Short-term Investments |
Investments, non-current |
|||||||||||||||||||
(in thousands) |
||||||||||||||||||||||||
Commercial paper |
$ | |
$ | $ | ( |
) | $ | $ | |
$ | — | |||||||||||||
Corporate debt securities |
— | ( |
) | |||||||||||||||||||||
Total |
$ | $ | $ | ( |
) | $ | $ | $ | |
|||||||||||||||
Estimated |
||||||||
Amortized |
Fair |
|||||||
Cost |
Value |
|||||||
(in thousands) |
||||||||
Due in one year or less |
$ | |
$ | |
||||
Due after one year through two years |
||||||||
$ | $ | |||||||
June 30, 2021 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(in thousands) |
||||||||||||||||
Assets: |
||||||||||||||||
Money markets funds (included in cash equivalents) |
$ | $ | — | $ | — | $ | ||||||||||
Commercial paper |
— | — | ||||||||||||||
Corporate debt securities |
— | — | ||||||||||||||
Total assets |
$ | $ | $ | — | $ | |||||||||||
December 31, 2020 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(in thousands) |
||||||||||||||||
Assets: |
||||||||||||||||
Money markets funds (included in cash equivalents) |
$ | $ | — | $ | — | $ | ||||||||||
Commercial paper |
— | — | ||||||||||||||
Corporate debt securities |
— | — | ||||||||||||||
Total assets |
$ | $ | $ | — | $ |
June 30, |
December 31, |
|||||||
2021 |
2020 |
|||||||
(in thousands) |
||||||||
Payroll and employee related expenses |
$ | $ | ||||||
External research and development |
||||||||
Other accrued expenses |
||||||||
Total accrued expenses |
$ | $ | ||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
(in thousands) |
(in thousands) |
|||||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total stock-based compensation expense |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
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June 30, |
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2020 |
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Options to purchase common stock |
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Redeemable convertible preferred stock |
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Item 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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prepare for, initiate and conduct additional clinical trials and preclinical studies of vidutolimod, including, among others, our current Phase 2 trial in anti-PD-1 anti-PD-1 anti-PD-1 |
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conduct the necessary scale-up activities to support the potential commercialization of vidutolimod, if approved; |
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hire additional clinical and scientific personnel to support our ongoing preclinical activities and clinical trials of vidutolimod and any other product candidates we choose to develop; |
• | develop any future product candidates; |
• | seek marketing approval for vidutolimod and any other product candidates that successfully complete clinical development; |
• | acquire or in-license additional product candidates; |
• | maintain compliance with applicable regulatory requirements; |
• | maintain, expand, protect and enforce our intellectual property portfolio; |
• | develop and expand our sales, marketing and distribution capabilities for vidutolimod and any other product candidates for which we obtain marketing approval; |
• | take precautionary measures to help minimize the risk of the coronavirus or any other future pandemic to our employees and encounter continued delays or interruptions related to current development activities, our supply chain, or the third-parties on whom we rely due to the COVID-19 pandemic; |
• | expand our infrastructure and facilities to accommodate the planned growth of our employee base; and |
• | expand our operational, financial and management systems and increase administrative personnel, including to support our clinical development and commercialization efforts and our operations as a public company. |
• | expenses incurred in connection with the preclinical and clinical development of our technology and vidutolimod, including clinical trials under agreements with contract research organizations (“CROs”), clinical investigators and consultants; |
• | employee-related expenses, including salaries, benefits and travel and stock-based compensation expense, for employees engaged in research and development functions; |
• | the cost of contract manufacturing organizations (“CMOs”), that manufacture drug product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities; |
• | costs related to compliance with regulatory requirements; |
• | payments made under third-party licensing agreements, such as the exclusive license agreement we entered into with Cytos Biotechnology LTD (now Kuros Biosciences AG, or “Kuros”) (the “Kuros License Agreement”); |
• | facilities and other expenses, which include direct and allocated expenses for facilities, insurance and supplies; and |
• | costs related to compliance with regulatory requirements. |
• | the scope, progress, outcome and costs of our preclinical studies and clinical trials for vidutolimod or any other product candidates we may acquire or develop; |
• | making arrangements with third-party manufacturers for both clinical and commercial supplies of vidutolimod or any other product candidates; |
• | successful patient enrollment in, and the initiation and completion of clinical trials; |
• | raising additional funds necessary to complete clinical development and the potential commercialization, of vidutolimod or any other product candidates; |
• | receipt, timing and related terms of marketing approvals from applicable regulatory authorities; |
• | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |
• | developing and implementing marketing and reimbursement strategies; |
• | establishing sales, marketing and distribution capabilities and launching commercial sales of vidutolimod or any other products, if approved, whether alone or in collaboration with others; |
• | acceptance of vidutolimod or any other products, if approved, by patients, the medical community and third-party payors; |
• | effectively competing with other therapies and/or changes in standard of care; |
• | obtaining and maintaining third-party coverage and adequate reimbursement; |
• | obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates; |
• | protecting and enforcing our rights in our intellectual property portfolio; |
• | significant and changing government regulations; and |
• | maintaining an acceptable tolerability profile of the products following approval, if any. |
Three months ended |
Six months ended |
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June 30, |
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June 30, |
Increase |
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2021 |
2020 |
(Decrease) |
2021 |
2020 |
(Decrease) |
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(unaudited, in thousands) |
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Operating expenses: |
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Research and development |
$ | 14,865 | $ | 6,476 | $ | 8,389 | $ | 25,243 | $ | 12,789 | $ | 12,454 | ||||||||||||
General and administrative |
4,090 | 1,795 | 2,295 | 7,893 | 3,305 | 4,588 | ||||||||||||||||||
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Total operating expenses |
18,955 | 8,271 | 10,684 | 33,136 | 16,094 | 17,042 | ||||||||||||||||||
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Loss from operations |
(18,955 | ) | (8,271 | ) | 10,684 | (33,136 | ) | (16,094 | ) | 17,042 | ||||||||||||||
Total other income (expense), net |
(15 | ) | (77 | ) | (62 | ) | 38 | (55 | ) | 93 | ||||||||||||||
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Net loss |
$ | (18,970 | ) | $ | (8,348 | ) | $ | 10,622 | $ | (33,098 | ) | $ | (16,149 | ) | $ | 16,949 | ||||||||
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Six months ended June 30, |
Increase |
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2021 |
2020 |
(Decrease) |
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( in thousands) |
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Net cash used in operating activities |
$ | (29,696 | ) | $ | (16,042 | ) | $ | 13,654 | ||||
Net cash provided by investing activities |
49,617 | — | 49,617 | |||||||||
Net cash provided by financing activities |
134 | 92,146 | (92,012 | ) | ||||||||
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Net increase in cash, cash equivalents and restricted cash |
$ | 20,055 | $ | 76,104 | $ | (56,049 | ) | |||||
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• | the initiation, progress, timing, costs and results of current and future preclinical studies and clinical trials for vidutolimod and any other product candidates we may develop or acquire in the future; |
• | the cost and timing of the manufacture of additional clinical trial materials and the completion of commercial-scale outsourced manufacturing activities; |
• | the costs to seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | the extent to which we experience delays or interruptions to preclinical studies and clinical trials, to our third-party service providers on whom we rely, or to our supply chain due to the COVID-19 pandemic; |
• | the need to hire additional clinical, quality assurance, quality control and other scientific personnel |
• | the number and characteristics of product candidates that we develop or may in-license; |
• | the outcome, timing and cost of meeting and maintaining compliance with regulatory requirements established by the U.S. Food and Drug Administration (the “FDA”), the European Medical Agency (the “EMA”) and other comparable foreign regulatory authorities; |
• | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights; |
• | the terms of any collaboration agreements we may choose to enter into; |
• | the cost associated with the expansion of our operational, financial and management systems and increased personnel, including personnel to support our operations as a public company; and |
• | the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products, if approved, on our own. |