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.) | |
th Floor |
||
(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
The |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
• |
the initiation, timing, progress, results, and cost of NVL-520 and NVL-655, as well as our discovery programs and our current and future preclinical and clinical studies, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our current and future programs; |
• |
the ability of our preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
• |
the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates; |
• |
the timing, scope and likelihood of regulatory filings and approvals, including timing of Investigational New Drug applications (“INDs”) and final U.S. Food and Drug Administration (“FDA”) approval of our current product candidates or any future product candidates; |
• |
the timing, scope or likelihood of foreign regulatory filings and approvals; |
• |
our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop product candidates, including by applying learnings from one program to other programs and from one indication to our other indications; |
• |
our estimates of the number of patients that we will enroll and our ability to initiate, recruit and enroll patients in and conduct and successfully complete our clinical trials at the pace that we project; |
• |
our ability to scale-up our manufacturing and processing approaches to appropriately address our anticipated commercial needs, which will require significant resources; |
• |
our ability to maintain and further develop the specific shipping, storage, handling and administration of NVL-520 and NVL-655 at the clinical sites; |
• |
our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates; |
• |
our ability to take advantage of accelerated regulatory pathways for our product candidates; |
• |
our ability to obtain and maintain regulatory approval of our product candidates; |
• |
our ability to commercialize our product candidates, if approved, including the geographic areas of focus and sales strategy; |
• |
the pricing and reimbursement of our product candidates, if approved; |
• |
the implementation of our business model, and strategic plans for our business, product candidates, and technology; |
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
• |
estimates of our future expenses, revenues, capital requirements, and our needs for additional financing; |
• |
the period over which we estimate our existing cash, cash equivalents and marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements; |
• |
future agreements with third parties in connection with the development and commercialization of our product candidates; |
• |
the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
• |
our financial performance; |
• |
the rate and degree of market acceptance of our product candidates; |
• |
regulatory developments in the United States and foreign countries; |
• |
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
• |
our ability to produce our product candidates with advantages in turnaround times or manufacturing cost; |
• |
our competitive position and the success of competing therapies that are or may become available; |
• |
our need for and ability to attract and retain key scientific, management and other personnel; |
• |
the impact of laws and regulations; |
• |
our expectations regarding the period during which we will remain an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”); |
• |
developments relating to our competitors and our industry; |
• |
the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and future clinical trials; and |
• |
other risks and uncertainties, including those listed under the section titled “Risk Factors.” |
• |
We are very early in our development efforts, have a limited operating history, have not completed any clinical trials, have no products approved for commercial sale and have not generated any revenue, which may make it difficult for investors to evaluate our current business and likelihood of success and viability; |
• |
We have incurred significant net losses in each period since our inception, and we expect to continue to incur significant net losses for the foreseeable future; |
• |
We are very early in our development efforts and our future prospects are substantially dependent on NVL-520 and NVL-655; |
• |
Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization; |
• |
Our discovery and preclinical development activities are focused on the development of targeted therapeutics for patients with cancer-associated genomic alterations, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to approved or marketable products; |
• |
In addition to NVL-520 and NVL-655, our prospects depend in part upon discovering, developing and commercializing additional product candidates from our ALK IXDN, HER2 and other discovery programs, which may fail in development or suffer delays that adversely affect their commercial viability; |
• |
Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and expand our approach to build a pipeline of product candidates with commercial value; |
• |
We may not be able to submit INDs, clinical trial applications (“CTAs”) or comparable applications to commence clinical trials on the timelines we expect, and even if we are able to, regulatory authorities may not permit us to proceed; |
• |
Our product candidates may cause undesirable adverse events when used alone or in combination with other products that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences; |
• |
If we experience delays or difficulties in the enrollment or maintenance of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented; |
• |
The effects of the ongoing COVID-19 pandemic could adversely impact our business, including our clinical trials and preclinical studies; |
• |
We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do; |
• |
If any of our third-party manufacturers encounter difficulties in production, our ability to provide adequate supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented; |
• |
The market opportunities for any product candidates we develop, if approved, may be limited to certain smaller patient subsets and may be smaller than we estimate them to be; |
• |
We may be unable to obtain U.S. or foreign regulatory approval and, as a result, may be unable to commercialize our product candidates; |
• |
We have never commercialized a product candidate as a company before and currently lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; |
• |
Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight; |
• |
Where appropriate, we plan to secure approval through the use of accelerated registration pathways. If we are unable to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals; |
• |
Our relationships with healthcare professionals, clinical investigators, contract research organizations (“CROs”) and third-party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to significant losses; |
• |
Our reliance on a limited number of employees who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business; |
• |
If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval; |
• |
If we are unable to obtain, maintain and enforce patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected; |
• |
We may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful; |
• |
Third parties may allege that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business; |
• |
If we are unable to protect the confidentiality of our trade secrets and other proprietary information, our business and competitive position would be adversely affected; |
• |
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected; |
• |
We rely on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies; |
• |
If we decide to establish collaborations, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans; |
• |
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance; |
• |
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval. Three of our directors are affiliated with our principal stockholders; |
• |
We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock. |
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83 |
September 30, |
December 31, |
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2021 |
2020 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Marketable securities |
— | |||||||
Prepaid expenses and other current assets |
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Total current assets |
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Other assets |
— | |||||||
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Total assets |
$ | $ | ||||||
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|||||
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
Preferred stock tranche rights |
— | |||||||
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|||||
Total current liabilities |
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Notes payable and accrued interest to stockholder |
— | |||||||
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Total liabilities |
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Commitments and contingencies (Note 10 ) |
||||||||
Convertible preferred stock (Series A and B), $ |
— | |||||||
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|
|
|||||
Stockholders’ equity (deficit): |
||||||||
Preferred stock, $ |
||||||||
Class A common stock, $ |
— | |||||||
Class B common stock, $ |
— | |||||||
Additional paid-in capital |
||||||||
Accumulated other comprehensive loss |
( |
) | — | |||||
Accumulated deficit |
( |
) | ( |
) | ||||
Promissory note from stockholder |
— | ( |
) | |||||
|
|
|
|
|||||
Total stockholders’ equity (deficit) |
( |
) | ||||||
|
|
|
|
|||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
$ | $ | ||||||
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
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|
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|
|
|
|||||||||
Total operating expenses |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Other income (expense): |
||||||||||||||||
Change in fair value of preferred stock tranche rights |
— | ( |
) | ( |
) | |||||||||||
Other income (expense), net |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total other income (expense), net |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
|||||||||
Weighted average shares of common stock outstanding, basic and diluted |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Comprehensive loss: |
||||||||||||||||
Net loss |
$ |
( |
) | $ |
( |
) | $ |
( |
) | $ |
( |
) | ||||
Other comprehensive loss: |
||||||||||||||||
Unrealized losses on marketable securities, net of tax of $ |
( |
) | — | ( |
) | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
|
|
|
|
|
|
|
|
Accumulated |
Total |
|||||||||||||||||||||||||||||||||||||||||||||||
Convertible |
Class A |
Class B |
Additional |
Other |
Promissory |
Stockholders’ |
||||||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Common Stock |
Common Stock |
Paid-in |
Comprehensive |
Accumulated |
Note from |
Equity |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Capital |
Loss |
Deficit |
Stockholder |
(Deficit) |
||||||||||||||||||||||||||||||||||||||
Balances at December 31, 2020 |
$ |
$ |
— |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||||
Issuance of Series A convertible preferred stock |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Conversion of note payable and accrued interest to Series A convertible preferred stock |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Interest on promissory note from |
— |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||||||||||||||||
Reclassification of preferred stock tranche rights upon settlement |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||||||||||
Loss on extinguishment of debt |
— |
— |
— |
— |
— |
— |
( |
) |
— |
— |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Balances at March 31, 2021 |
— |
— |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||||||||||||||
Issuance of Series B convertible preferred stock, net of issuance costs of $ |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Interest on promissory note from related stockholder party |
— |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Balances at June 30, 2021 |
— |
— |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||||||||||||||
Conversion of preferred stock to common stock upon initial public offering |
( |
) |
( |
) |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||
Issuance of common stock upon initial public offering, net of issuance costs of $ |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Repayment of promissory note from related stockholder party |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Unrealized losses on marketable securities |
— |
— |
— |
— |
— |
— |
— |
( |
) |
— |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Balances at September 30, 2021 |
— |
$ |
— |
$ |
$ |
$ |
$ |
( |
) | $ |
( |
) |
$ |
— |
$ |
Accumulated |
||||||||||||||||||||||||||||||||||||||||||||||||
Convertible |
Class A |
Class B |
Additional |
Other |
Promissory |
Total |
||||||||||||||||||||||||||||||||||||||||||
Preferred Stock |
Common Stock |
Common Stock |
Paid-in |
Comprehensive |
Accumulated |
Note from |
Stockholders’ |
|||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Capital |
Loss |
Deficit |
Stockholder |
Deficit |
||||||||||||||||||||||||||||||||||||||
Balances at December 31, 2019 |
$ |
$ |
— |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||||
Issuance of Series A convertible preferred stock |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Reclassification of preferred stock tranche rights upon settlement |
— |
( |
) |
— |
— |
— |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||||||||
Net income |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Balances at March 31, 2020 |
— |
— |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||||||||||||||
Issuance of common stock |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||||||||||
Issuance of promissory note from related party stockholder |
— |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Interest on promissory note from related party stockholder |
— |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Balances at June 30, 2020 |
— |
— |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||||||||||||||
Issuance of Series A convertible preferred stock |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Reclassification of preferred stock tranche rights upon settlement |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||||||||||
Interest on promissory note from related party stockholder |
— |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
— |
( |
) | |||||||||||||||||||||||||||||||||||
Balances at September 30, 2020 |
$ |
$ |
— |
— |
$ |
— |
$ |
$ |
— |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||||||||||||||||||||||||||||
Nine |
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Change in fair value of preferred stock tranche rights |
( |
) | ||||||
Stock-based compensation expense |
||||||||
Non-cash interest income on promissory note |
( |
) | ( |
) | ||||
Net amortization of premiums on marketable securities |
— | |||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ( |
) | ||||
Other assets |
( |
) | — | |||||
Accounts payable |
||||||||
Accrued expenses |
||||||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
Cash flows from investing activities: |
||||||||
Purchases of marketable securities |
( |
) | — | |||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) | — | |||||
Cash flows from financing activities: |
||||||||
Proceeds from issuance of convertible preferred stock and preferred stock tranche rights, net of issuance costs |
||||||||
Proceeds from initial public offering, net of underwriting discounts and commissions |
— | |||||||
Issuance of promissory note to stockholder |
— | ( |
) | |||||
Payments of insurance costs financed by a third-party |
( |
) | — | |||||
Proceeds from repayment of promissory note to stockholder |
— | |||||||
Payments of initial public offering costs |
( |
) | — | |||||
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Net cash provided by financing activities |
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Net increase in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
$ | $ | ||||||
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Supplemental disclosure of noncash financing information: |
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Settlement of notes payable and accrued interest for preferred stock |
$ | $ | — | |||||
Conversion of convertible preferred stock to common stock upon initial public offering |
$ | $ | — | |||||
Insurance premium financed by a third-party |
$ | $ | — | |||||
Loss on extinguishment of debt |
$ | $ | — | |||||
Settlement of preferred stock tranche rights |
$ | $ | ( |
) | ||||
Initial public offering costs in accounts payable |
$ | $ | — |
1. |
Nature of Business and Basis of Presentation |
• |
Level 1—Quoted prices in active markets for identical assets or liabilities. |
• |
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. |
• |
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
As of September 30, |
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2021 |
2020 |
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Convertible preferred stock (as converted to common stock) |
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Unvested restricted common stock |
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Options to purchase common stock |
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September 30, 2021 |
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Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair Value |
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Commercial paper (due within one year) |
$ | $ | — | $ | ( |
) | $ | |||||||||
Corporate bonds (due within one year) |
— | ( |
) | |||||||||||||
Corporate bonds (due after one year through two years) |
— | ( |
) | |||||||||||||
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$ | $ | — | $ | ( |
) | $ | ||||||||||
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Fair Value Measurements at September 30, 2021 Using: |
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Level 1 |
Level 2 |
Level 3 |
Total |
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Assets: |
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Cash equivalents: |
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Money market funds |
$ | $ | — | $ | — | $ | ||||||||||
Commercial paper |
— | — | ||||||||||||||
Marketable securities: |
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Corporate bonds |
— | — | ||||||||||||||
Commercial paper |
— | — | ||||||||||||||
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$ | $ | $ | — | $ | ||||||||||||
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Fair Value Measurements at December 31, 2020 Using: |
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Level 1 |
Level 2 |
Level 3 |
Total |
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Liabilities: |
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Preferred stock tranche rights |
$ | — | $ | — | $ | $ | ||||||||||
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Preferred Stock Tranche Rights |
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Fair value at December 31, 2020 |
$ | |||
Change in fair value |
||||
Settlement of preferred stock tranche rights |
( |
) | ||
|
|
|||
Fair value at September 30, 2021 |
$ | |||
|
|
September 30, 2021 |
December 31, 2020 |
|||||||
Accrued employee compensation and benefits |
$ | $ | ||||||
Accrued external research and development expenses |
||||||||
Accrued professional fees |
||||||||
Other |
||||||||
|
|
|
|
|||||
$ | $ | |||||||
|
|
|
|
Preferred Stock Authorized |
Preferred Stock Issued and Outstanding |
Carrying Value |
Liquidation Preference |
Common Stock Issuable Upon Conversion |
||||||||||||||||
(in thousands) |
(in thousands) |
|||||||||||||||||||
Series A Preferred Stock |
$ | $ | ||||||||||||||||||
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$ | $ | |||||||||||||||||||
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|
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|
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|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Research and development expenses |
$ | $ | $ | $ | ||||||||||||
General and administrative expenses |
||||||||||||||||
$ | $ | $ | $ | |||||||||||||
• | advance our NVL-520 and NVL-655 programs from preclinical development into clinical development; |
• | advance the development of our discovery programs, including our ALK IXDN and HER2 programs; |
• | expand our pipeline of product candidates through our own product discovery and development efforts; |
• | seek to discover and develop additional product candidates; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs; |
• | implement operational, financial and management systems; |
• | attract, hire and retain additional clinical, scientific, management and administrative personnel; |
• | maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; |
• | acquire or in-license other product candidates and technologies; and |
• | operate as a public company. |
• | personnel-related costs, including salaries, benefits and stock-based compensation expense, for employees engaged in research and development functions; |
• | expenses incurred in connection with our research programs, including under agreements with third parties, such as consultants and contractors and CROs; |
• | the cost of developing and scaling our manufacturing process and manufacturing drug substance and drug product for use in our research and preclinical and clinical studies, including under agreements with third parties, such as consultants and contractors and contract manufacturing organizations (“CMOs”); and |
• | the cost of laboratory supplies and research materials. |
• | the timing and progress of development activities relating to NVL-520, NVL-655 and any future product candidates from our ALK IXDN, HER2 and other discovery programs, including any additional costs that may result from delays in enrollment or other factors; |
• | the number and scope of preclinical and clinical programs we decide to pursue; |
• | our ability to maintain our current research and development programs and to establish new ones; |
• | establishing an appropriate safety profile with IND-enabling toxicology studies; |
• | successful patient enrollment in, and the initiation and completion of, clinical trials; |
• | the number of trials required for regulatory approval; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible subjects and initial clinical trials; |
• | the number of subjects that participate in the trials and per subject trial costs; |
• | potential additional safety monitoring requested by regulatory authorities; |
• | the duration of subject participation in the trials and follow-up; |
• | the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities; |
• | the receipt of regulatory approvals from applicable regulatory authorities; |
• | the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; |
• | the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party; |
• | establishing commercial manufacturing capabilities or making arrangements with CMOs; |
• | development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; and |
• | obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights. |
Three Months Ended September 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 9,055 | $ | 3,721 | $ | 5,334 | ||||||
General and administrative |
3,372 | 319 | 3,053 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
12,427 | 4,040 | 8,387 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(12,427 | ) | (4,040 | ) | (8,387 | ) | ||||||
|
|
|
|
|
|
|||||||
Other income (expense): |
||||||||||||
Change in fair value of preferred stock tranche rights |
— | (724 | ) | 724 | ||||||||
Other income (expense), net |
1 | (14 | ) | 15 | ||||||||
|
|
|
|
|
|
|||||||
Total other income (expense), net |
1 | (738 | ) | 739 | ||||||||
|
|
|
|
|
|
|||||||
Net loss |
$ | (12,426 | ) | $ | (4,778 | ) | $ | 7,648 | ||||
|
|
|
|
|
|
Three Months Ended September 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Direct research and development expenses by program: |
||||||||||||
NVL-520 |
$ | 3,019 | $ | 1,350 | $ | 1,669 | ||||||
NVL-655 |
1,086 | 740 | 346 | |||||||||
Discovery programs |
2,098 | 751 | 1,347 | |||||||||
Unallocated research and development expenses: |
||||||||||||
Personnel-related (including stock-based compensation) |
2,801 | 613 | 2,188 | |||||||||
Other |
51 | 267 | (216 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total research and development expenses |
$ | 9,055 | $ | 3,721 | $ | 5,334 | ||||||
|
|
|
|
|
|
Three Months Ended September 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Personnel-related (including stock-based compensation) |
$ | 1,955 | $ | 224 | $ | 1,731 | ||||||
Professional and consultant fees |
599 | 67 | 532 | |||||||||
Other |
818 | 28 | 790 | |||||||||
|
|
|
|
|
|
|||||||
Total general and administrative expenses |
$ | 3,372 | $ | 319 | $ | 3,053 | ||||||
|
|
|
|
|
|
Nine Months Ended September 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 22,365 | $ | 10,704 | $ | 11,661 | ||||||
General and administrative |
6,074 | 987 | 5,087 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
28,439 | 11,691 | 16,748 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(28,439 | ) | (11,691 | ) | (16,748 | ) | ||||||
|
|
|
|
|
|
|||||||
Other income (expense): |
||||||||||||
Change in fair value of preferred stock tranche rights |
(635 | ) | 3,747 | (4,382 | ) | |||||||
Other income (expense), net |
25 | (32 | ) | 57 | ||||||||
|
|
|
|
|
|
|||||||
Total other income (expense), net |
(610 | ) | 3,715 | (4,325 | ) | |||||||
|
|
|
|
|
|
|||||||
Net loss |
$ | (29,049 | ) | $ | (7,976 | ) | $ | (21,073 | ) | |||
|
|
|
|
|
|
Nine Months Ended September 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Direct research and development expenses by program: |
||||||||||||
NVL-520 |
$ | 7,277 | $ | 3,204 | $ | 4,073 | ||||||
NVL-655 |
4,258 | 1,882 | 2,376 | |||||||||
Discovery programs |
4,975 | 2,519 | 2,456 | |||||||||
Unallocated research and development expenses: |
||||||||||||
Personnel-related (including stock-based compensation) |
5,359 | 2,268 | 3,091 | |||||||||
Other |
496 | 831 | (335 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total research and development expenses |
$ | 22,365 | $ | 10,704 | $ | 11,661 | ||||||
|
|
|
|
|
|
Nine Months Ended September 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Personnel-related (including stock-based compensation) |
$ | 3,038 | $ | 619 | $ | 2,419 | ||||||
Professional and consultant fees |
1,838 | 245 | 1,593 | |||||||||
Other |
1,198 | 123 | 1,075 | |||||||||
|
|
|
|
|
|
|||||||
Total general and administrative expenses |
$ | 6,074 | $ | 987 | $ | 5,087 | ||||||
|
|
|
|
|
|
Nine Months Ended September 30, |
||||||||
2021 |
2020 |
|||||||
(in thousands) |
||||||||
Cash used in operating activities |
$ | (27,045 | ) | $ | (10,012 | ) | ||
Cash used in investing activities |
(56,567 | ) | — | |||||
Cash provided by financing activities |
319,166 | 22,250 | ||||||
|
|
|
|
|||||
Net increase in cash and cash equivalents |
$ | 235,554 | $ | 12,238 | ||||
|
|
|
|
• | the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our discovery programs and product candidates, including the planned advancement of NVL-520 and NVL-655 throughout clinical development; |
• | the clinical development plans we establish for our product candidates; |
• | the number and characteristics of product candidates that we discover and develop through our product discovery and research efforts; |
• | the terms of any collaboration agreements we may choose to pursue; |
• | the outcome, timing and cost of meeting regulatory requirements established by the FDA, the European Medicine Agency (“EMA”) and other comparable foreign regulatory authorities; |
• | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights; |
• | the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us; |
• | the effect of competing technological and market developments; |
• | the cost and timing of completion of commercial-scale outsourced manufacturing activities; 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 on our own. |
• | successful and timely completion of preclinical and clinical development of NVL-520, NVL-655 and any future product candidates from our ALK IXDN, HER2 and other discovery programs, and any other future programs; |
• | establishing and maintaining relationships with CROs and clinical sites for the clinical development of NVL-520, NVL-655 and any future product candidates from our ALK IXDN, HER2 and other current or future discovery programs; |
• | timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development; |
• | developing an efficient and scalable manufacturing process for our product candidates, including the production of finished products that are appropriately packaged for sale if our product candidates obtain marketing approvals; |
• | establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved; |
• | successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; |
• | a continued acceptable safety profile following any marketing approval of our product candidates; |
• | commercial acceptance of our product candidates by patients, the medical community and third-party payors including the willingness of physicians to use our product candidates, if approved, in lieu of (or as a second-line treatment in conjunction with) other approved therapies; |
• | satisfying any required post-marketing approval commitments to applicable regulatory authorities; |
• | identifying, assessing and developing new product candidates; |
• | obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States (the “U.S.”) and internationally; |
• | defending against third-party interference or infringement claims, if any; |
• | entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
• | obtaining coverage and adequate reimbursement by third-party payors for our product candidates, if approved; |
• | addressing any competing therapies and technological and market developments; and |
• | attracting, hiring and retaining qualified personnel. |
• | successful and timely completion of preclinical studies; |
• | submission of INDs in the U.S. and CTAs and/or comparable applications outside the U.S. for regulatory authority review and agreement to proceed with our clinical trials; |
• | our ability to address any potential delays resulting from factors related to the COVID-19 pandemic; |
• | successful initiation and completion of clinical trials; |
• | successful and timely patient selection and enrollment in and completion of clinical trials; |
• | maintaining and establishing relationships with CROs and clinical sites for the clinical development of our product candidates both in the U.S. and internationally; |
• | maintaining and growing an organization of chemists, medical professionals and clinical development professionals who can develop and commercialize our product candidates; |
• | the frequency and severity of adverse events in clinical trials; |
• | obtaining positive data that support demonstration of efficacy, safety and tolerability profiles and durability of effect for our product candidates that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; |
• | the timely receipt of marketing approvals from applicable regulatory authorities; |
• | the timely identification, development and approval of companion diagnostic tests, if required; |
• | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |
• | the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of our product candidates; |
• | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the U.S. and internationally; |
• | the protection of our rights in our intellectual property portfolio; |
• | establishing sales, marketing and distribution capabilities and the successful launch of commercial sales of our product candidates if and when approved for marketing, whether alone or in collaboration with others; |
• | a continued acceptable safety profile following any marketing approval; |
• | commercial acceptance by patients, the medical community and third-party payors, including the willingness of physicians to use our product candidates, if approved, in lieu of (or as a second-line treatment in conjunction with) other approved therapies; and |
• | our ability to compete with other therapies. |
• | failure of our product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy; |
• | receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; |
• | negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research, discovery and/or drug development programs; |
• | the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated, particularly if there are other trials enrolling the same or overlapping precisely targeted patient populations, or participants dropping out of these clinical trials at a higher rate than anticipated; |
• | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable adverse events or other unexpected characteristics or risks; |
• | the cost of clinical trials of our product candidates being greater than anticipated; |
• | the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and |
• | regulators revising the requirements for approving our product candidates. |
• | generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials; |
• | addressing any delays resulting from factors related to the ongoing COVID-19 pandemic; |
• | obtaining regulatory permission to initiate clinical trials; |
• | contracting with the necessary parties to conduct clinical trials; |
• | successful enrollment of patients in, and the completion of, clinical trials on a timely basis; |
• | the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and |
• | adverse events in clinical trials. |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
• | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | the clinical data of the clinical trial may fail to meet the level of statistical significance required to obtain approval of our product candidates by the FDA, EMA or other comparable foreign regulatory authorities; |
• | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; |
• | the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for our product candidates; |
• | we may not obtain or maintain adequate funding to complete the clinical trial in a manner that is satisfactory to the FDA, EMA or other comparable foreign regulatory authorities; and |
• | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | size and nature of the patient population; |
• | severity of the disease under investigation; |
• | availability and efficacy of approved drugs for the disease under investigation; |
• | patient eligibility criteria for the trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have a biomarker-driven patient eligibility criteria; |
• | perceived risks and benefits of the product candidate under study; |
• | clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating; |
• | clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials; |
• | patient referral practices of physicians; |
• | the ability to monitor patients adequately during and after treatment; |
• | proximity and availability of clinical trial sites for prospective patients; and |
• | the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials. |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | delays or difficulties in enrolling and retaining patients in any clinical trials, particularly elderly subjects, who are at a higher risk of severe illness or death from COVID-19; |
• | difficulties interpreting data from our clinical trials due to the possible effects of COVID-19 on patients; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others; |
• | interruption or delays in the operations of the FDA, EMA or other regulatory authorities, which may impact review and approval timelines; |
• | limitations in resources that would otherwise be focused on the conduct of our business, our preclinical studies or our clinical trials, including because of sickness or the desire to avoid contact with large groups of people or as a result of government-imposed “shelter in place” or similar working restrictions; |
• | interruptions, difficulties or delays arising in our existing operations and company culture as a result of the majority of our employees working remotely, including those hired during the COVID-19 pandemic; |
• | delays in receiving approval from regulatory authorities to initiate our clinical trials; |
• | delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; |
• | interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies; |
• | interruption in global freight and shipping that may affect the transport of clinical trial materials, such as investigational drug product to be used in our clinical trials; |
• | changes in regulations as part of a response to the ongoing COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, or to discontinue the clinical trials altogether, or which may result in unexpected costs; |
• | delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and |
• | refusal of the FDA, EMA or other regulatory authorities to accept data from clinical trials in affected geographies outside of their respective jurisdictions. |
• | the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments; |
• | the timing of market introduction of the product candidate as well as competitive products; |
• | the clinical indications for which a product candidate is approved; |
• | restrictions on the use of product candidates in the labelling approved by regulatory authorities, such as boxed warnings or contraindications in labelling, or a Risk Evaluation and Mitigation Strategy (“REMS”), if any, which may not be required of alternative treatments and competitor products; |
• | the potential and perceived advantages of our product candidates over alternative treatments; |
• | the cost of treatment in relation to alternative treatments; |
• | the availability of coverage and adequate reimbursement by third-party payors, including government authorities; |
• | willingness of physicians to use our product candidates, if approved, in lieu of (or as a second-line treatment in conjunction with) other approved therapies; |
• | the availability of an approved product candidate for use as a combination therapy; |
• | relative convenience and ease of administration; |
• | the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests; |
• | the effectiveness of sales and marketing efforts; |
• | unfavorable publicity relating to our product candidates; and |
• | the approval of other new therapies for the same indications. |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
• | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective or have undesirable or unintended adverse events, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
• | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | delays in or the rejection of product approvals; |
• | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
• | restrictions on the products, manufacturers or manufacturing process; |
• | warning or untitled letters; |
• | civil and criminal penalties; |
• | injunctions; |
• | suspension or withdrawal of regulatory approvals; |
• | product seizures, detentions or import bans; |
• | voluntary or mandatory product recalls and publicity requirements; |
• | total or partial suspension of production; |
• | imposition of restrictions on operations, including costly new manufacturing requirements; |
• | revisions to the labelling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; |
• | imposition of a REMS, which may include distribution or use restrictions; and |
• | requirements to conduct additional post-market clinical trials to assess the safety of the product. |
• | the demand for our product candidates, if we obtain regulatory approval; |
• | our ability to set a price that we believe is fair for our products; |
• | our ability to obtain coverage and reimbursement approval for a product; |
• | our ability to generate revenue and achieve or maintain profitability; |
• | the level of taxes that we are required to pay; and |
• | the availability of capital. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil |
and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act (“FCA”). There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection; |
• | federal civil and criminal false claims laws, including the FCA, which can be enforced through civil “qui tam” or “whistleblower” actions, and civil monetary penalty laws, impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent; knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the federal civil FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; |
• | HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (i.e., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; |
• | HIPAA, which imposes requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information as well as their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization. HIPAA has tiers of civil monetary penalties, which are directly applicable to business associates. HIPAA also authorizes state attorneys general to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions; |
• | the federal Physician Payments Sunshine Act, created under the ACA and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include payments and transfers of value made and ownership interests held during the previous year to certain non-physician providers such as physician assistants and nurse practitioners; and |
• | analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. |
• | identifying, recruiting, integrating, maintaining, retaining and motivating our current and additional employees; |
• | managing our internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory authorities’ review process for NVL-520 and NVL-655 and our other programs, while complying with any contractual obligations to contractors and other third parties; |
• | managing increasing operational and managerial complexity; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being more costly than obtaining approval in the U.S.; |
• | foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from preclinical studies or clinical trials; |
• | approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; |
• | impact of the COVID-19 pandemic on our ability to produce our product candidates and conduct clinical trials in foreign countries; |
• | unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with legal requirements applicable to privacy, data protection, information security and other matters; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; |
• | difficulties staffing and managing foreign operations; |
• | complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries; |
• | workforce uncertainty in countries where labor unrest is more common than in the U.S.; |
• | potential liability under the FCPA or comparable foreign regulations; |
• | challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geo-political actions, including war and terrorism, trade policies, treaties and tariffs. |
• | the scope of rights granted under the license agreement and other matters of contract interpretation; |
• | whether and the extent to which our technology and processes infringe the intellectual property rights of the licensor that are not subject to the licensing agreement; |
• | whether our licensor or its licensor had the right to grant the license agreement; |
• | whether third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property rights without their authorization; |
• | our involvement in the prosecution of licensed patents and our licensors’ overall patent enforcement strategy; |
• | the amounts of royalties, milestones or other payments due under the license agreement; |
• | the sublicensing of patent and other rights under collaborative development relationships; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and |
• | the priority of invention of patented technology. |
• | If we do not prevail in such disputes, we may lose any or all of our rights under such license agreements. |
• | the failure of the third party to manufacture our product candidates according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them; |
• | the reduction or termination of production or deliveries by suppliers, or the raising or prices or renegotiation of terms; |
• | the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us; |
• | the breach by the third-party contractors of our agreements with them; |
• | the failure of third party to manufacture our product candidates according to our specifications; |
• | the failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs; |
• | the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; |
• | clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and |
• | the misappropriation of our proprietary information, including our trade secrets and know-how. |
• | increased operating expenses and cash requirements; |
• | the assumption of additional indebtedness or contingent liabilities; |
• | the issuance of our equity securities; |
• | assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel; |
• | the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition; |
• | retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships; |
• | risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and |
• | our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs. |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected; |
• | collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a business combination or sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; |
• | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
• | collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
• | a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; |
• | we may grant exclusive rights to our collaborators that would prevent us from collaborating with others; |
• | collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; |
• | disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources; |
• | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; |
• | collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; |
• | collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates; |
• | collaborators may own or co-own intellectual property covering our products or product candidates that result from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and |
• | a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. |
• | the timing and results of INDs, preclinical studies and clinical trials of our product candidates or those of our competitors; |
• | the success of competitive products or announcements by potential competitors of their product development efforts; |
• | regulatory actions with respect to our products or product candidates or our competitors’ products or product candidates; |
• | actual or anticipated changes in our growth rate relative to our competitors; |
• | regulatory or legal developments in the U.S. and other countries; |
• | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
• | the recruitment or departure of key personnel; |
• | announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments; |
• | actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | market conditions in the pharmaceutical and biotechnology sector; |
• | changes in the structure of healthcare payment systems; |
• | share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; |
• | announcement or expectation of additional financing efforts; |
• | sales of our common stock by us, our insiders or our other stockholders; |
• | expiration of market stand-off or lock-up agreements; |
• | the impact of any natural disasters or public health emergencies, such as the ongoing COVID-19 pandemic; and |
• | general economic, political, industry and market conditions. |
• | the timing and cost of, and level of investment in, research and development activities relating to our programs, which will change from time to time; |
• | our ability to enroll patients in clinical trials and the timing of enrollment; |
• | the cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements, the quantity of production and the terms of our agreements with manufacturers; |
• | expenditures that we will or may incur to acquire or develop additional product candidates and technologies or other assets; |
• | the timing and outcomes of preclinical studies and clinical trials for NVL-520 and NVL-655, and any product candidates from our discovery programs, or competing product candidates; |
• | the need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated; |
• | competition from existing and potential future products that compete with NVL-520 or NVL-655 or any of our discovery programs, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners; |
• | any delays in regulatory review or approval of NVL-520 and NVL-655 or product candidates from any of our discovery programs; |
• | the level of demand for any of our product candidates, if approved, which may fluctuate significantly and be difficult to predict; |
• | the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future products that compete with NVL-520 and NVL-655, or any of our discovery programs; |
• | our ability to commercialize NVL-520 or NVL-655, or product candidates from any of our discovery programs, if approved, inside and outside of the U.S., either independently or working with third parties; |
• | our ability to establish and maintain collaborations, licensing or other arrangements; |
• | our ability to adequately support future growth; |
• | potential unforeseen business disruptions that increase our costs or expenses; |
• | future accounting pronouncements or changes in our accounting policies; and |
• | the changing and volatile global economic and political environment. |
• | being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in our periodic reports; |
• | not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”); |
• | not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; |
• | reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and |
• | exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. |
• | a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; |
• | a prohibition on stockholder actions through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders; |
• | a requirement that special meetings of stockholders be called only by the board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors then in office; |
• | advance notice requirements for stockholder proposals and nominations for election to our board of directors; |
• | a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors; |
• | a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and |
• | the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock. |
* | Filed herewith. |
# | Indicates a management contract or any compensatory plan, contract or arrangement. |
† | Portions of this exhibit (indicated by asterisks) have been omitted in accordance with Item 601(b)(10) of Regulation S-K. |
+ | The certifications furnished in Exhibit 32.1 hereto are deemed to be furnished with this Quarterly Report on Form 10-Q and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. |
Date: November 10, 2021 | By: | /s/ James R. Porter | ||||
James R. Porter | ||||||
President and Chief Executive Officer (Principal Executive Officer) |
Date: November 10, 2021 | By: | /s/ Alexandra Balcom | ||||
Alexandra Balcom | ||||||
Chief Financial Officer (Principal Accounting Officer and Principal Financial Officer) |
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James R. Porter, certify that:
1. | I have reviewed this Form 10-Q for the Quarterly Period Ended September 30, 2021 of Nuvalent, 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 registrants 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)) 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) | (Paragraph omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313); |
(c) | Evaluated the effectiveness of the registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants 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 registrants internal control over financial reporting. |
Date: November 10, 2021 | By: | /s/ James R. Porter | ||||
James R. Porter | ||||||
President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Alexandra Balcom, certify that:
1. | I have reviewed this Form 10-Q for the Quarterly Period Ended September 30, 2021 of Nuvalent, 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 registrants 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)) 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) | (Paragraph omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313); |
(c) | Evaluated the effectiveness of the registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants 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 registrants internal control over financial reporting. |
Date: November 10, 2021 | By: | /s/ Alexandra Balcom | ||||
Alexandra Balcom | ||||||
Chief Financial Officer (Principal Accounting Officer and Principal Financial Officer) |
Exhibit 32.1
CERTIFICATIONS OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Nuvalent, Inc. (the Company) for the quarterly period ended September 30, 2021 as filed with the Securities and Exchange Commission on the date hereof (the Report), the undersigned hereby certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of their knowledge:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: November 10, 2021 | By: | /s/ James R. Porter | ||||
James R. Porter | ||||||
President and Chief Executive Officer (Principal Executive Officer) |
Date: November 10, 2021 | By: | /s/ Alexandra Balcom | ||||
Alexandra Balcom | ||||||
Chief Financial Officer (Principal Financial and Accounting Officer) |
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Operating expenses: | ||||
Research and development | $ 9,055 | $ 3,721 | $ 22,365 | $ 10,704 |
General and administrative | 3,372 | 319 | 6,074 | 987 |
Total operating expenses | 12,427 | 4,040 | 28,439 | 11,691 |
Loss from operations | (12,427) | (4,040) | (28,439) | (11,691) |
Other income (expense): | ||||
Change in fair value of preferred stock tranche rights | (724) | (635) | 3,747 | |
Other income (expense), net | 1 | (14) | 25 | (32) |
Total other income (expense), net | 1 | (738) | (610) | 3,715 |
Net loss | $ (12,426) | $ (4,778) | $ (29,049) | $ (7,976) |
Net loss per share attributable to common stockholders, basic | $ (0.39) | $ (1.57) | $ (2.26) | $ (2.85) |
Net loss per share attributable to common stockholders, diluted | $ (0.39) | $ (1.57) | $ (2.26) | $ (2.85) |
Weighted average shares of common stock outstanding, basic | 32,066,089 | 3,042,398 | 12,858,574 | 2,798,910 |
Weighted average shares of common stock outstanding, diluted | 32,066,089 | 3,042,398 | 12,858,574 | 2,798,910 |
Comprehensive loss: | ||||
Net loss | $ (12,426) | $ (4,778) | $ (29,049) | $ (7,976) |
Other comprehensive loss: | ||||
Unrealized losses on marketable securities, net of tax of $0 | (23) | (23) | ||
Comprehensive loss | $ (12,449) | $ (4,778) | $ (29,072) | $ (7,976) |
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2021
USD ($)
| |
Income Statement [Abstract] | |
Unrealized losses on marketable securities, tax | $ 0 |
STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Sep. 30, 2021 |
Jun. 30, 2021 |
|
Series B convertible preferred stock [Member] | ||
Temporary Equity Issuance Costs | $ 348 | |
Common Stock [Member] | ||
Stock Issuance Costs | $ 3,020 |
Nature of Business and Basis of Presentation |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2021 | |||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Nature of Business and Basis of Presentation |
Nuvalent, Inc. (the “Company”) is a biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. The Company was founded in January 2017 as a Delaware corporation. The Company is headquartered in Cambridge, Massachusetts. The Company is subject to risks similar to those of other pre-commercial stage companies in the biopharmaceutical industry, including dependence on key individuals, the need to develop commercially viable products, competition from other companies, many of whom are larger and better capitalized, the impact of the COVID-19 pandemic and the need to obtain adequate additional financing to fund the development of its product candidates. There can be no assurance that the Company’s research and development will be successful, that adequate protection for the Company’s intellectual property will be obtained and maintained, that any product candidates will receive required regulatory approval or that approved products, if any, will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from the sale of its products. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. The Company’s operations have not been significantly impacted by the COVID-19 pandemic. However, the Company cannot at this time predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on its financial condition and operations, including its conduct of clinical trials. The impact of the COVID-19 outbreak on the Company’s financial performance will depend on future developments, including the duration and spread of the pandemic and related governmental advisories and restrictions. These developments and the impact of COVID-19 on the financial markets and the overall economy are highly uncertain and cannot be predicted. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s results may be materially adversely affected. On July 23, 2021, the Company effected a one-for-5.38213 On July 23, 2021, the Company filed an amendment to its amended and restated certificate of incorporation, which effected a recapitalization of the Company’s then outstanding common stock to Class A common stock and authorized an additional new class of common stock (“Class B common stock”). The rights of the holders of Class A common stock and Class B common stock are substantially identical, except with respect to voting and conversion. Each share of Class A common stock is entitled to one vote and shares of Class B common stock are non-voting, except as may be required by law. Each share of Class B common stock may be converted at any time into one share of Class A common stock at the option of its holder, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. On August 2, 2021, the Company completed an initial public offering (“IPO”) of its common stock and issued and sold 10,612,500 shares of Class A and 600,000 shares of Class B common stock at a public offering price of $17.00 per share, inclusive of 1,462,500 shares of Class A common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares. The Company received net proceeds of approximately $174.3 million after deducting underwriting discounts and commissions and offering costs. In connection with the IPO, the Company’s outstanding convertible preferred stock automatically converted into shares of Class A and Class B common stock. Basis of presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Since its inception, the Company has funded its operations primarily with proceeds from sales of preferred stock, issuance of convertible notes (which converted in 2018), debt financing from its investors (which was settled with convertible preferred stock in February 2021), and most recently, with proceeds from the sale of common stock in the IPO completed in August 2021. The Company has incurred recurring losses since inception, including net losses of $29.0 million for the nine months ended September 30, 2021 and $14.6 million for the year ended December 31, 2020. As of September 30, 2021, the Company had an accumulated deficit of $60.9 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date of issuance of these financial statements. The Company will need to obtain additional funding through public or private equity offerings, debt financings or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into strategic alliances. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. Arrangements with collaborators or others may require the Company to relinquish rights to certain of its technologies or programs. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs or the Company may be unable to continue operations. Although management will continue to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations when needed or at all. |
Summary of Significant Accounting Policies |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the valuation of common stock, the valuation of stock-based awards, preferred stock tranche rights and the accrual of research and development expenses. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions. Unaudited interim financial information The balance sheet at December 31, 2020 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Registration Statement on Form S-1, as amended, File No. 333-257730 on file with the SEC. In the opinion of management, these financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2021 and results of operations for the three and nine months ended September 30, 2021 and 2020 and cash flows for the nine months ended September 30, 2021 and 2020. The Company’s results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021. Concentrations of credit risk and of significant suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. As of September 30, 2021 and December 31, 2020, the Company maintained cash, cash equivalents and marketable securities balances in excess of federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party vendors for the manufacturing of its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture materials and components required for the production of its product candidates. These programs could be adversely affected by a significant interruption in the manufacturing process. Fair value measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities . Marketable securities The Company’s marketable securities (non-equity instruments) are classified as available-for-sale . The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge recorded in the statements of operations. No such adjustments were necessary during the periods presented. The Company classifies its marketable securities with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities are available for current operations. Research and development costs Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock-based compensation, employee benefits, consulting costs, and external costs of vendors engaged to conduct research, preclinical and clinical development activities. Costs for research and development activities are expensed in the period in which they are incurred. Payments for such activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid expense or accrued research and development expense. Determining the prepaid and accrued balances at the end of any reporting period incorporates certain judgments and estimates by management that are based on information available to the Company including information provided by vendors regarding the progress to completion of specific tasks or costs incurred. Stock-based compensation The Company measures stock options with service-based vesting granted to employees, non-employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model. The Company measures restricted common stock awards using the difference between the purchase price per share of the award, if any, and the fair value of the Company’s common stock at the date of grant. Compensation expense for the awards is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company uses the straight-line method to record the expense of awards with service-based vesting conditions. The Company accounts for forfeitures of share-based awards as they occur. The Company classifies stock-based compensation expense in its statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Net income (loss) per share Prior to the closing of the IPO, the Company followed the two-class method when computing net income (loss) per share, as the Company had issued shares that meet the definition of participating securities. The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Subsequent to the closing of its IPO, basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted stock units. For periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive. The Company has two classes of common stock outstanding: Class A common stock and Class B common stock. As more fully described in Note 8, the rights of the holders of Class A and Class B common stock are substantially identical, except with respect to voting and conversion. Each share of Class B common stock is convertible into one share of Class A common stock at the option of the holder at any time, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. The Company allocates undistributed earnings attributable to common stock between the common stock classes on a one-to-one The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2021 and 2020 because including them would have had an anti-dilutive effect:
Recently issued accounting pronouncements The Company qualifies as an “emerging growth company” as defined in the JOBS Act and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires lessees to recognize most leases on their balance sheet as a right-of-use 2016-02, a right of use asset and lease obligation is recorded for all leases, whether operating or financing, while the income statement reflects lease expense for operating leases and amortization/interest expense for financing leases. The FASB also issued ASU 2018-10, Codification Improvements to Topic 842 Leases, and ASU 2018-11, Targeted Improvements to Topic 842 Leases, which allows the new lease standard to be applied as of the adoption date with a cumulative-effect adjustment to the opening balance of retained earnings rather than retroactive restatement of all periods presented. In June 2020, the FASB issued ASU No. 2020-05, which grants a one-year effective-date delay for nonpublic entities to annual reporting periods beginning after December 15, 2021 and to interim periods within fiscal years beginning after December 15, 2022. Early adoption continues to be permitted. Upon adoption of this guidance, the Company will record right-of-use In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326). The new standard adjusts the accounting for assets held at amortized costs basis, including marketable securities accounted for as available for sale, and trade receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For public entities except smaller reporting companies, the guidance is effective for annual reporting periods beginning after December 15, 2019 and for interim periods within those years. For nonpublic entities and smaller reporting companies, the guidance was effective for annual reporting periods beginning after December 15, 2021. Early adoption is permitted for all entities. In November 2019, the FASB issued ASU No. 2019-10, which deferred the effective date for nonpublic entities to annual reporting periods beginning after December 15, 2022, including interim periods within those years. Early application continues to be allowed. The Company is currently assessing the impact of the adoption of this guidance on its financial statements. |
Marketable Securities |
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Marketable Securities | 3. Marketable Securities Marketable securities by security type consisted of the following (in thousands):
The Company had no marketable securities as of December 31, 2020 . |
Fair Value Measurements |
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Fair Value Measurements | 4. Fair Value Measurements The following tables present the Company’s fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands):
Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. Corporate bonds and commercial paper were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. During the three and nine months ended September 30, 2021 and 2020, there were no transfers in or out of Level 3. The following table provides a roll-forward of the aggregate fair values of the Company’s preferred stock tranche rights, for which fair value was determined by Level 3 inputs (in thousands):
The preferred stock tranche rights represented the fair value of the rights and obligations of the original purchasers of the Series A convertible preferred stock to participate in subsequent closings of Series A convertible preferred stock upon the achievement of certain strategic milestones or as determined by the Series A investors (the “Series A Tranche Rights”), which were fully settled by March 31, 2021. The Series A Tranche Rights met the definition of a freestanding financial instrument as the Series A Tranche Rights were legally detachable and separately exercisable from the Series A convertible preferred stock. The fair value of the Series A Tranche Rights were initially classified as a liability and recorded at fair value and were subject to revaluation at each balance sheet date until each Series A Tranche Right was exercised. The fair values of the Series A Tranche Rights were based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The Company’s valuation of the Series A Tranche Rights utilized a scenario-based valuation analysis, which incorporated assumptions and estimates to value the Series A Tranche Rights and a probability assessment of the achievement of the milestones. The Company assessed these assumptions and estimates at the end of each reporting period as additional information impacting the assumptions were obtained. The quantitative elements associated with the Company’s Level 3 inputs impacting the fair value measurement of the Series A Tranche Rights included the fair value per share of the underlying convertible preferred stock, the expected term of the Series A Tranche Rights, risk-free interest rate, expected dividend yield and expected volatility of the price of the underlying convertible preferred stock. The Company determined the fair value per share of the underlying convertible preferred stock by taking into consideration its most recent sales of its convertible preferred stock as well as additional factors that the Company deemed relevant. The Company historically has been a private company and lacks company-specific historical and implied volatility information of its stock. Therefore, it estimated its expected stock volatility based on the historical volatility of a representative group of public companies in the biotechnology industry for the expected terms. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the expected terms. The Company estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared dividends. The Company assessed the probabilities of achieving the milestones related to each tranche upon issuance and at the end of each reporting period. Probabilities ranged from 90.0% to 100.0% and expected terms ranged from 0.2 years to 1.6 years. As of December 31, 2020, the fair value of the Company’s Series A convertible preferred stock was $0.53 per share. The Series A Tranche Rights were exercised in March 2020, August 2020 and February 2021. All Series A Tranche Rights were settled by March 31, 2021. |
Accrued Expenses |
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Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following (in thousands):
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Notes Payable to Related Party |
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Related Party Transactions [Abstract] | |
Notes Payable to Related Party | 6. Notes Payable to Related Party In February 2017, the Company issued $2.0 million of promissory notes (the “Notes”) to Deerfield Healthcare Innovations Fund, L.P. and Deerfield Private Design Fund, IV, L.P. (collectively “Deerfield”), an investor in the Company. The Notes accrued interest at a rate of 2.81% per annum, compounded annually, and matured upon the earlier of a change in control event as defined in the Company’s charter or five years from issuance. In connection with the issuance of the Notes, the Company entered into a revenue share agreement with Deerfield for contingent payments of a low single digit percentage rate of net sales of commercial product (see Note 10). In February 2021, the Company issued 5,025,604 shares of Series A convertible preferred stock in full settlement of the Notes and accrued interest. The issuance of the Series A convertible preferred stock was recorded at fair value and as a result, the Company recorded a loss on extinguishment of debt of $0.6
million upon the conversion representing the difference between the carrying value of the Notes and the fair value of the Series A convertible preferred stock. The loss on extinguishment of debt was recognized as additional paid-in capital, a component of stockholders’ equity (deficit), due to the related party nature of the Notes. |
Convertible Preferred Stock |
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Convertible Preferred Stock | 7. Convertible Preferred Stock The Company had issued Series A convertible preferred stock (the “Series A”) and Series B convertible preferred stock (the “Series B”). The Series A and Series B are collectively referred to as the “Preferred Stock”. Preferred Stock consisted of the following as of December 31, 2020:
In April 2021, the Company issued and sold 65,223,679 shares of Series B at a price of $2.0698 per share, for gross proceeds of $135.0 million. There were no tranche rights granted in connection with the Series B issuance and sale. Upon the closing of the IPO, all of the shares of the Company’s outstanding Preferred Stock automatically converted into shares of Class A and Class B common stock. |
Common Stock |
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Equity [Abstract] | |
Common Stock | 8. Common Stock On July 23, 2021, the Company filed an amendment to its amended and restated certificate of incorporation, which effected a recapitalization of the Company’s then outstanding common stock to Class A common stock and authorized an additional new class of Class B common stock. The rights of the holders of Class A common stock and Class B common stock are substantially identical, except with respect to voting and conversion. Each share of Class A common stock is entitled to one vote and shares of Class B common stock are non-voting, except as may be required by law. Each share of Class B common stock may be converted at any time into one share of Class A common stock at the option of its holder, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. Restricted common stock The Company has outstanding shares of restricted common stock. Shares of unvested restricted common stock may not be sold or transferred by the holder. Vesting may be accelerated upon a change in control, as defined in the restricted stock agreement. If the holders cease to have a business relationship with the Company, the Company may repurchase any unvested shares of common stock held by these individuals at their original purchase price (which was a nominal amount). |
Stock-Based Compensation |
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Stock-Based Compensation | 9. Stock-Based Compensation 2017 Stock Option and Grant Plan The Company’s 2017 Stock Option and Grant Plan (the “2017 Plan”) provided for the Company to grant incentive stock options or nonqualified stock options and other equity awards to employees, directors and consultants of the Company. The 2017 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions were determined at the discretion of the board of directors, or its committee if so delegated. Upon effectiveness of the Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) in August 2021, the remaining shares available under the 2017 Plan ceased to be available for issuance and no future issuances will be made under the 2017 Plan. 2021 Equity Incentive Plan On July 23, 2021, the Company’s board of directors adopted and its stockholders approved the 2021 Plan, which became effective on J uly 28options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, cash-based awards and dividend equivalent rights. The number of Class A shares of common stock initially reserved for issuance under the 2021 Plan is 5,866,004, which shall be cumulatively increased on January 1, 2022 and each January 1 thereafter by 5.0% of the number of shares of the Company’s Class A and Class B common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors. The shares of Class A common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2021 Plan and the 2017 Plan will be added back to the shares of Class A common stock available under the 2021 Plan. As of September 30, 2021, 5,441,507 shares remained available for future issuance under the 2021 Plan.2021 Employee Stock Purchase Plan On July 23, 2021, the Company’s board of directors adopted and its stockholders approved the 2021 Employee Stock Purchase Plan (the “ESPP”), which became effective on July 28, 2021. A total of Option Grants During the nine months ended September 30, 2021, the Company granted options to its employees and directors with service-based vesting for the purchase of an aggregate of 3,360,647 shares of common stock with a total grant-date fair value of $18.0 million. Stock-based compensation The Company recorded stock-based compensation expense related to common stock options and restricted common stock in the following expense categories of its statements of operations and comprehensive loss (in thousands):
As of September 30, 2021, total unrecognized compensation cost related to common stock options and unvested restricted stock was $16.4 million, which is expected to be recognized over a weighted average period of 3.2 years. |
Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Revenue share The Company has revenue sharing agreements with Deerfield and the Company’s scientific founder to pay each of Deerfield and the scientific founder a low single digit percentage rate of net sales of certain commercial products. The payment obligation expires on the later of twelve years from the first commercial sale in a country or the expiration of the last-to-expire Indemnification agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, contract research organizations, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company has not incurred any material costs as a result of such indemnifications and is not currently aware of any indemnification claims. |
Defined Contribution Plan |
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Defined Contribution Plan [Abstract] | |
Defined Contribution Plan | 11. Defined Contribution Plan The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for its employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits. There was no discretionary match made under the 401(k) Plan as of September 30, 2021 and December 31, 2020. In September 2021, the Company adopted a match program for employee contributions to the 401(k) Plan up to a maximum of percent of the employee’s salary for the year ended December 31, 2022. |
Related Parties |
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Related Party Transactions [Abstract] | |
Related Parties | 12. Related Parties The Company had issued certain promissory notes to Deerfield, an investor in the Company. In February 2021, the promissory notes and accrued interest were converted to Series A (see Note 6). The Company is obligated to pay low single digit percentage rates of net sales of certain commercial products to Deerfield and its scientific founder. As of September 30, 2021 and December 31, 2020, no products have been commercialized and no amounts have been paid or become due (see Note 10). In February 2017, the Company entered into a three-year consulting agreement with the scientific founder of the Company who is also a board member and a stockholder. The consulting agreement between the scientific founder and the Company continues at will. During the three months ended September 30, 2021 and 2020, the Company paid the scientific founder $0.2 million and $0.1 million, respectively. During the nine months ended September 30, 2021 and 2020, the Company paid $0.3 million and $0.1 million, respectively. As of September 30, 2021 and December 31, 2020, the Company had less than $0.1 million and no accounts payable, respectively, to the scientific founder. In June 2020, the Company loaned $0.3 million to the scientific founder of the Company who is also a board member and a stockholder of the Company related to the issuance of common stock (see Note 9) pu r suant to a promissory note. The promissory note provided that the unpaid principal amount of the loan bore interest at 2.86% annually, and interest was payable annually or was converted to principal at the maturity date. The promissory note provided that the maturity date of the promissory note would occur on the earliest to occur of (i) June 11, 2024, (ii) 60 calendar days following the date of termination of services of the stockholder, and (iii) immediately prior to an initial filing of a registration statement by the Company. The promissory note was fully repaid and cancelled in July 2021. |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Use of estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the valuation of common stock, the valuation of stock-based awards, preferred stock tranche rights and the accrual of research and development expenses. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Actual results may differ from those estimates or assumptions. |
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Unaudited interim financial information | Unaudited interim financial information The balance sheet at December 31, 2020 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Registration Statement on Form S-1, as amended, File No. 333-257730 on file with the SEC. In the opinion of management, these financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the Company’s financial position as of September 30, 2021 and results of operations for the three and nine months ended September 30, 2021 and 2020 and cash flows for the nine months ended September 30, 2021 and 2020. The Company’s results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021. |
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Concentrations of credit risk and of significant suppliers | Concentrations of credit risk and of significant suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. As of September 30, 2021 and December 31, 2020, the Company maintained cash, cash equivalents and marketable securities balances in excess of federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on third-party vendors for the manufacturing of its product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of vendors to manufacture materials and components required for the production of its product candidates. These programs could be adversely affected by a significant interruption in the manufacturing process. |
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Fair value measurements | Fair value measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities . |
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Marketable securities | Marketable securities The Company’s marketable securities (non-equity instruments) are classified as available-for-sale . The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge recorded in the statements of operations. No such adjustments were necessary during the periods presented. The Company classifies its marketable securities with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities are available for current operations. |
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Research and development costs | Research and development costs Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, stock-based compensation, employee benefits, consulting costs, and external costs of vendors engaged to conduct research, preclinical and clinical development activities. Costs for research and development activities are expensed in the period in which they are incurred. Payments for such activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid expense or accrued research and development expense. Determining the prepaid and accrued balances at the end of any reporting period incorporates certain judgments and estimates by management that are based on information available to the Company including information provided by vendors regarding the progress to completion of specific tasks or costs incurred. |
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Stock-based compensation | Stock-based compensation The Company measures stock options with service-based vesting granted to employees, non-employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model. The Company measures restricted common stock awards using the difference between the purchase price per share of the award, if any, and the fair value of the Company’s common stock at the date of grant. Compensation expense for the awards is recognized over the requisite service period, which is generally the vesting period of the respective award. The Company uses the straight-line method to record the expense of awards with service-based vesting conditions. The Company accounts for forfeitures of share-based awards as they occur. The Company classifies stock-based compensation expense in its statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. |
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Net income (loss) per share | Net income (loss) per share Prior to the closing of the IPO, the Company followed the two-class method when computing net income (loss) per share, as the Company had issued shares that meet the definition of participating securities. The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Subsequent to the closing of its IPO, basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted stock units. For periods in which the Company reported a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their affect is anti-dilutive. The Company has two classes of common stock outstanding: Class A common stock and Class B common stock. As more fully described in Note 8, the rights of the holders of Class A and Class B common stock are substantially identical, except with respect to voting and conversion. Each share of Class B common stock is convertible into one share of Class A common stock at the option of the holder at any time, subject to the ownership limitations provided for in the Company’s amended and restated certificate of incorporation. The Company allocates undistributed earnings attributable to common stock between the common stock classes on a one-to-one The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2021 and 2020 because including them would have had an anti-dilutive effect:
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Recently issued accounting pronouncements | Recently issued accounting pronouncements The Company qualifies as an “emerging growth company” as defined in the JOBS Act and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires lessees to recognize most leases on their balance sheet as a right-of-use 2016-02, a right of use asset and lease obligation is recorded for all leases, whether operating or financing, while the income statement reflects lease expense for operating leases and amortization/interest expense for financing leases. The FASB also issued ASU 2018-10, Codification Improvements to Topic 842 Leases, and ASU 2018-11, Targeted Improvements to Topic 842 Leases, which allows the new lease standard to be applied as of the adoption date with a cumulative-effect adjustment to the opening balance of retained earnings rather than retroactive restatement of all periods presented. In June 2020, the FASB issued ASU No. 2020-05, which grants a one-year effective-date delay for nonpublic entities to annual reporting periods beginning after December 15, 2021 and to interim periods within fiscal years beginning after December 15, 2022. Early adoption continues to be permitted. Upon adoption of this guidance, the Company will record right-of-use In June 2016, the FASB issued ASU
No. 2016-13, Financial Instruments – Credit Losses (Topic 326). The new standard adjusts the accounting for assets held at amortized costs basis, including marketable securities accounted for as available for sale, and trade receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For public entities except smaller reporting companies, the guidance is effective for annual reporting periods beginning after December 15, 2019 and for interim periods within those years. For nonpublic entities and smaller reporting companies, the guidance was effective for annual reporting periods beginning after December 15, 2021. Early adoption is permitted for all entities. In November 2019, the FASB issued ASU No. 2019-10, which deferred the effective date for nonpublic entities to annual reporting periods beginning after December 15, 2022, including interim periods within those years. Early application continues to be allowed. The Company is currently assessing the impact of the adoption of this guidance on its financial statements. |
Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2021 and 2020 because including them would have had an anti-dilutive effect:
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Marketable Securities (Tables) |
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Marketable Securities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Marketable securities by Security | Marketable securities by security type consisted of the following (in thousands):
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Fair Value Measurements (Tables) |
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Schedule of Fair Value Assets and Liabilities Measured on Recurring Basis | The following tables present the Company’s fair value hierarchy for its assets and liabilities, which are measured at fair value on a recurring basis (in thousands):
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Schedule of Roll Forward of the Aggregate Fair Value of the Preferred Stock Tranche Rights | The following table provides a roll-forward of the aggregate fair values of the Company’s preferred stock tranche rights, for which fair value was determined by Level 3 inputs (in thousands):
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Accrued Expenses (Tables) |
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Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands):
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Convertible Preferred Stock (Tables) |
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Stockholders' Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Redeemable Convertible Preferred Stock | Preferred Stock consisted of the following as of December 31, 2020:
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Stock-Based Compensation (Tables) |
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Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock-Based Compensation Expenses | The Company recorded stock-based compensation expense related to common stock options and restricted common stock in the following expense categories of its statements of operations and comprehensive loss (in thousands):
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Marketable Securities - Summary of Marketable securities by Security (Detail) $ in Thousands |
Sep. 30, 2021
USD ($)
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Marketable Securities [Line Items] | |
Amortized Cost | $ 56,566 |
Gross Unrealized Losses | (23) |
Fair Value | 56,543 |
Corporate bonds | Due from one to two years | |
Marketable Securities [Line Items] | |
Amortized Cost | 2,040 |
Gross Unrealized Losses | (2) |
Fair Value | 2,038 |
Corporate bonds | Due within one year | |
Marketable Securities [Line Items] | |
Amortized Cost | 8,257 |
Gross Unrealized Losses | (4) |
Fair Value | 8,253 |
Commercial paper | |
Marketable Securities [Line Items] | |
Amortized Cost | 46,269 |
Gross Unrealized Losses | (17) |
Fair Value | $ 46,252 |
Marketable Securities - Additional Information (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Marketable Securities [Abstract] | ||
Marketable securities | $ 56,543 | $ 0 |
Fair Value Measurements - Schedule of Roll Forward of the Aggregate Fair Value of the Preferred Stock Tranche Rights (Detail) - Preferred stock tranche rights [Member] - Fair value, inputs, level 3 [Member] $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2021
USD ($)
| |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Fair value at December 31, 2020 | $ 1,957 |
Change in fair value | 635 |
Settlement of preferred stock tranche rights | (2,592) |
Fair value at September 30, 2021 | $ 0 |
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Accrued Liabilities, Current [Abstract] | ||
Accrued employee compensation and benefits | $ 1,679 | $ 636 |
Accrued external research and development expenses | 880 | 405 |
Accrued professional fees | 1,751 | 103 |
Other | 0 | 27 |
Total Accrued expenses | $ 4,310 | $ 1,171 |
Convertible Preferred Stock - Summary of Redeemable Convertible Preferred Stock (Detail) $ in Thousands |
Dec. 31, 2020
USD ($)
shares
|
---|---|
Temporary Equity [Line Items] | |
Preferred Stock Authorized | 112,431,508 |
Preferred Stock Issued | 89,945,206 |
Preferred Stock Outstanding | 89,945,206 |
Carrying Value | $ | $ 35,354 |
Liquidation Preference | $ | $ 40,000 |
Common Stock Issuable Upon Conversion | 16,711,823 |
Series A Preferred Stock [Member] | |
Temporary Equity [Line Items] | |
Preferred Stock Authorized | 112,431,508 |
Preferred Stock Issued | 89,945,206 |
Preferred Stock Outstanding | 89,945,206 |
Carrying Value | $ | $ 35,354 |
Liquidation Preference | $ | $ 40,000 |
Common Stock Issuable Upon Conversion | 16,711,823 |
Convertible Preferred Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | 9 Months Ended | |
---|---|---|---|
Apr. 30, 2021 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Class of Stock [Line Items] | |||
Gross Proceeds from issuance of convertible preferred stock | $ 144,652 | $ 22,500 | |
Series B convertible preferred stock [Member] | |||
Class of Stock [Line Items] | |||
Issuance of convertible preferred stock , Shares | 65,223,679 | ||
Issuance price per share | $ 2.0698 | ||
Gross Proceeds from issuance of convertible preferred stock | $ 135,000 | ||
Number of tranche rights granted temporary equity | 0 |
Stock-Based Compensation - Summary of Stock-Based Compensation Expenses (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 1,373 | $ 35 | $ 2,163 | $ 687 |
Research and Development Expenses [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | 476 | 12 | 786 | 641 |
General and Administrative Expenses [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 897 | $ 23 | $ 1,377 | $ 46 |
Commitments and Contingencies - Additional Information (Detail) - USD ($) |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Accrued liability | $ 0 | $ 0 |
Defined Contribution Plan - Additional Information (Detail) - USD ($) |
9 Months Ended | 12 Months Ended | |
---|---|---|---|
Sep. 30, 2021 |
Dec. 31, 2022 |
Dec. 31, 2020 |
|
Defined contribution plan, employer discretionary contribution amount | $ 0 | $ 0 | |
Forecast [Member] | |||
Defined contribution plan employer matching contribution percent of match | 6.00% |
Related Parties - Additional Information (Detail) - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
Dec. 31, 2020 |
Jun. 30, 2020 |
|
Consulting Agreement [Member] | ||||||
Related party amounts paid | $ 0.2 | $ 0.1 | $ 0.3 | $ 0.1 | ||
Accounts payable, related parties | $ 0.0 | |||||
Consulting Agreement [Member] | Maximum [Member] | ||||||
Accounts payable, related parties | $ 0.1 | $ 0.1 | ||||
Scientific Founder [Member] | ||||||
Notes receivable related parties | $ 0.3 | |||||
Loan bears interest rate | 2.86% | |||||
Promissory note maturity date description | The promissory note provided that the maturity date of the promissory note would occur on the earliest to occur of (i) June 11, 2024, (ii) 60 calendar days following the date of termination of services of the stockholder, and (iii) immediately prior to an initial filing of a registration statement by the Company. |
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