Delaware |
2834 |
26-3058238 | ||
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification Number) |
Alan C. Smith Amanda L. Rose Ryan Mitteness Fenwick & West LLP 1191 Second Avenue, Floor 10 Seattle, WA 98101 (206) 389-4510 |
Michael Nordtvedt Bryan D. King Tony Jeffries Wilson Sonsini Goodrich & Rosati, Professional Corporation 701 Fifth Avenue, Suite 5100 Seattle, WA 98104 (206) 883-2500 |
Large accelerated filer | ☐ |
Accelerated filer | ☐ | |||
☒ |
Smaller reporting company | |||||
Emerging growth company |
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Title of each class of securities to be registered |
Proposed maximum aggregate offering price(1)(2) |
Amount of registration fee | ||
Common Stock, par value $0.001 per share |
$64,342,500 |
$7,020 | ||
| ||||
|
(1) |
Includes additional shares that the underwriters have the option to purchase. |
(2) |
Estimated solely for purposes of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended. |
PROSPECTUS (Subject to Completion) |
Dated September 7, 2021 |
Per Share |
Total |
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Public offering price |
$ |
$ |
||||||
Underwriting discounts and commissions(1) |
$ |
$ |
||||||
Proceeds, before expenses, to Impel NeuroPharma, Inc. |
$ |
$ |
(1) | See the section titled “Underwriting” for additional information regarding underwriting compensation. |
Cowen |
Guggenheim Securities |
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F-1 |
∎ |
Rapid Onset |
∎ |
Consistent Drug Bioavailability |
∎ |
Improved Patient-Provider Experience |
∎ |
Manufacturability co-formulating our therapeutics inside of a pressurized propellant canister. |
∎ |
Formulation Versatility |
∎ |
Strong Intellectual Property Position ex-U.S. jurisdictions directed to our approach of drug delivery to the upper nasal cavity, including claims directed to a nasal device with separate drug and propellant compartments. Our patent portfolio is expected to provide patent protection ranging from 2032 to 2040. |
∎ |
38% of patients were pain free at two hours after their first dose of TRUDHESA. |
∎ |
52% of patients receiving TRUDHESA were free of their most bothersome migraine symptom at two hours. |
∎ |
Patients treated with TRUDHESA also demonstrated improvement in pain relief: 16% of patients treated with TRUDHESA had pain relief within 15 minutes of treatment, and 66% had pain relief within two hours. |
∎ |
38% of patients treated with TRUDHESA remained pain free at two hours through three months of treatment and 34% of patients treated with TRUDHESA remained pain free at two hours through six months of treatment. |
∎ |
Patients who received TRUDHESA saw a 48% reduction in the frequency of their migraines compared to baseline during the six-month trial. |
∎ |
93% and 86% of patients achieving pain freedom at two hours on TRUDHESA did not suffer a relapse in migraine or require a rescue medication at 24 hours and 48 hours, respectively. |
∎ |
Exposure Adjusted Event Rate, or EAER, data showed a meaningful reduction in the usage of healthcare resources by patients treated with TRUDHESA versus their baseline. Emergency room visits were reduced by approximately 73% and hospitalizations and urgent care visits were reduced by 100%. |
∎ |
Successfully commercialize TRUDHESA for the acute treatment of migraine headaches with or without aura in adult patients. |
∎ |
Rapidly advance INP105 through clinical development for the acute treatment of agitation and aggression associated with ASD. |
∎ |
Maximize the therapeutic and commercial potential of our proprietary POD technology platform. |
∎ |
Expand applications of our existing product candidates. |
∎ |
Independently develop and commercialize product candidates in indications and geographies where we believe we can maximize value. |
∎ |
We are a commercial-stage biopharmaceutical company with a limited operating history and have incurred net losses since our inception. We anticipate that we will continue to incur substantial operating losses for the foreseeable future and we may never achieve or sustain profitability. |
∎ |
We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts. |
∎ |
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates on unfavorable terms to us. |
∎ |
The development and commercialization of pharmaceutical products is subject to extensive regulation, and we may not obtain regulatory approvals for INP105, INP107 or any other product candidates. |
∎ |
Our future commercial success depends upon attaining significant market acceptance of TRUDHESA and our product candidates, if approved, among physicians, patients, health care payors and others in the medical community necessary for commercial success. |
∎ |
Clinical failure may occur at any stage of clinical development, and we may never succeed in developing marketable product candidates or generating product revenue. |
∎ |
Delays in the commencement, enrollment or completion of clinical trials of our product candidates, or in the acceptance of foreign clinical trial data, could result in increased costs to us as well as a delay or failure in obtaining regulatory approval, or prevent us from commercializing our product candidates on a timely basis, or at all. |
∎ |
The outbreak of COVID-19, or similar public health crises, could have a material adverse impact on our business, financial condition and results of operations, including through disruption to our planned clinical trials, supply chains, business operations and commercialization efforts. |
∎ |
We rely entirely on third parties for the manufacturing of TRUDHESA and our product candidates that we develop for nonclinical studies and clinical trials and expect to continue to do so for commercialization. If we encounter difficulties in negotiating manufacturing and supply agreements with third-party manufacturers and suppliers of our POD device and the active ingredients in TRUDHESA, INP105, and INP107, our ability to commercialize TRUDHESA and our product candidates, if approved, would be impaired. |
∎ |
If we are not able to obtain and enforce patent protection for our technologies, TRUDHESA or product candidates, development and commercialization of our technology, TRUDHESA and product candidates may be adversely affected. |
∎ |
We may encounter difficulties in managing our growth and expanding our operations successfully. |
∎ |
If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop and commercialize our product candidates. |
∎ |
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. |
∎ |
being permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus; |
∎ |
not being required to comply with the auditor attestation requirements on the effectiveness of our internal controls over financial reporting; |
∎ |
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 (auditor discussion and analysis); |
∎ |
reduced disclosure obligations regarding executive compensation arrangements; and |
∎ |
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. |
Common stock offered |
3,000,000 shares |
Option to purchase additional shares |
We have granted the underwriters an option, exercisable for 30 days after the date of this prospectus, to purchase up to an additional 450,000 shares from us. See the section of this prospectus titled “Underwriting.” |
Common stock to be outstanding immediately after this offering |
22,470,914 shares (or 22,920,914 shares if the underwriters exercise their option to purchase additional shares in full). |
Use of proceeds |
We estimate that the net proceeds from this offering will be approximately $51.8 million (or approximately $59.7 million if the underwriters exercise their option to purchase additional shares in full), based upon the assumed public offering price of $18.65 per share, which is the last reported sale price of our common stock on The Nasdaq Global Market on September 3, 2021, after deducting the estimated underwriting discounts and commissions and estimated offering expenses. |
We intend to use the net proceeds we receive in this offering to fund the initial and ongoing commercial launch activities and market development activities for TRUDHESA, advance INP105 into a clinical proof-of-concept |
Risk factors |
You should read the section titled “Risk Factors” in this prospectus for a discussion of factors to consider carefully before deciding to invest in shares of our common stock. |
Nasdaq Global Market symbol |
“IMPL” |
∎ |
2,770,785 shares of common stock issuable upon the exercise of options outstanding as of June 30, 2021, with a weighted-average exercise price of $6.25 per share; |
∎ |
621,010 shares of our common stock issuable upon the exercise of stock options granted after June 30, 2021, with a weighted-average exercise price of $12.48 per share; |
∎ |
71,522 shares of our common stock issuable upon the exercise of warrants issued after June 30, 2021, with an exercise price of $8.389 per share; and |
∎ |
2,449,021 shares of common stock reserved for future issuance under our stock-based compensation plans as of June 30, 2021, consisting of (i) 2,173,021 shares of common stock reserved for future issuance under our 2021 Equity Incentive Plan as of June 30, 2021 and (ii) 276,000 shares of common stock reserved for future issuance under our 2021 Employee Stock Purchase Plan. |
∎ |
no exercise of outstanding options or warrants after June 30, 2021, other than as described above; and |
∎ |
no exercise of the underwriters’ option to purchase additional shares of our common stock. |
Year ended December 31, |
Six Months ended June 20, 2021 |
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2020 |
2019 |
2021 |
2020 |
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(in thousands, except share and per share data) |
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Statement of Operations Data: |
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Operating expenses: |
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Research and development |
$ | 27,285 | $ | 28,812 | $ | 10,174 | $ | 13,391 | ||||||||
General and administrative |
18,049 | 12,754 | 14,633 | 9,374 | ||||||||||||
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Total operating expenses |
45,334 | 41,566 | 24,807 | 22,765 | ||||||||||||
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Loss from operations |
(45,334 | ) | (41,566 | ) | (24,807 | ) | (22,765 | ) | ||||||||
Other (expense) income, net |
(463 | ) | (263 | ) | (1,966 | ) | 84 | |||||||||
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Loss before income taxes |
(45,797 | ) | (41,829 | ) | (26,773 | ) | (22,681 | ) | ||||||||
Provision (benefit) for income taxes |
(1 | ) | (30 | ) | |
– |
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– |
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Net loss and comprehensive loss |
$ | (45,798 | ) | $ | (41,859 | ) | (26,773 | ) | (22,681 | ) | ||||||
Accretion on redeemable convertible preferred stock |
(518 | ) | (505 | ) | 129 | 256 | ||||||||||
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Net loss attributable to common stockholders |
$ | (46,316 | ) | $ | (42,364 | ) | (26,902 | ) | (22,937 | ) | ||||||
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Per share information: |
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Net loss per share attributable to common stockholders, basic and diluted(1) |
$ | (91.05 | ) | $ | (122.07 | ) | (3.60 | ) | (63.32 | ) | ||||||
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted(1) |
508,668 | 347,042 | 7,475,242 | 362,246 | ||||||||||||
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(1) | See Note 13 to our audited financial statements included elsewhere in this prospectus for an explanation of the method used to calculate basic and diluted net loss per share and basic and diluted weighted-average number of shares of common stock used in the computation of the per share amounts. |
As of June 30, 2021 |
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Actual |
As Adjusted(1)(2) |
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(in thousands) |
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Balance Sheet Data: |
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Cash and cash equivalents |
$ | 60,948 | $ | 112,781 | ||||
Working capital (3) |
56,560 | 108,393 | ||||||
Total assets |
69,162 | 120,995 | ||||||
Long-term debt |
8,857 | 8,857 | ||||||
Total stockholders’ equity |
51,298 | 103,131 |
(1) | The as adjusted amounts reflect the sale of 3,000,000 shares of our common stock in this offering, based upon an assumed public offering price of $18.65 per share, which is the last reported sale price of our common stock on the Nasdaq Global Market on September 3, 2021, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
(2) | The as adjusted information is illustrative only, and will change based on the actual public offering price and other terms of this offering determined at pricing. A $1.00 increase (decrease) in the assumed public offering price of $18.65 per share, the last reported sale price of our common stock on the Nasdaq Global Market on September 3, 2021, would increase (decrease) the as adjusted amount of each of cash, working capital, total assets and total stockholders’ equity by $2.8 million, assuming that the number of shares offered by us, as set forth on the cover of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions. Similarly, each increase (decrease) of 1.0 million in the number of shares offered by us in this offering would increase (decrease) the as adjusted amount of each of cash, working capital, total assets and total stockholders’ equity by $17.5 million, assuming the assumed offering price remains the same and after deducting estimated underwriting discounts and commissions. |
(3) | We define working capital as current assets less current liabilities. |
∎ |
the cost of commercialization activities for TRUDHESA, or any other approved product, including marketing, sales and distribution costs; |
∎ |
the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates if clinical trials are successful; |
∎ |
the scope, progress, results and costs of developing and advancing our product candidates through clinical trials and researching and discovering new product candidates; |
∎ |
our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; |
∎ |
the cost of manufacturing our product candidates for clinical trials in preparation for regulatory approval and in preparation for commercialization; |
∎ |
our ability to generate revenue from approved product candidates, if any; and |
∎ |
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation. |
∎ |
variation in the level of expense related to the commercialization of TRUDHESA or any other product candidates that receives regulatory approval, and quarterly fluctuations in product sales or TRUDHESA or any other product candidates that receives regulatory approval; |
∎ |
variations in the level of expense related to the ongoing development of our product candidates or future development programs; |
∎ |
results of nonclinical and clinical trials, or the addition or termination of clinical trials or funding support by us, or existing or future collaborators or licensing partners; |
∎ |
our execution of any additional collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under existing or future arrangements or the termination or modification of any such existing or future arrangements; |
∎ |
any intellectual property infringement lawsuit or opposition, interference or cancellation proceeding in which we may become involved; |
∎ |
additions and departures of key personnel; |
∎ |
strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; |
∎ |
if any of our product candidates receive regulatory approval, the terms of such approval and market acceptance and demand for such product candidates; |
∎ |
regulatory developments affecting our product candidates or those of our competitors; and |
∎ |
changes in general market and economic conditions. |
∎ |
may not deem our product candidate to be safe and effective; |
∎ |
determines that the product candidate does not have an acceptable benefit-risk profile; |
∎ |
determines in the case of an NDA seeking accelerated approval that the NDA does not provide evidence that the product candidate represents a meaningful advantage over available therapies; |
∎ |
determines that the objective response rate, or ORR, and duration of response are not clinically meaningful; |
∎ |
may not agree that the data collected from preclinical studies and clinical trials are acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval, and may impose requirements for additional preclinical studies or clinical trials; |
∎ |
may determine that adverse events experienced by participants in our clinical trials represent an unacceptable level of risk; |
∎ |
may determine that population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; |
∎ |
may disagree regarding the formulation, labeling and/or the specifications; |
∎ |
may not approve the manufacturing processes associated with our product candidate or may determine that a manufacturing facility does not have an acceptable compliance status; |
∎ |
may conclude there are CMC issues that preclude approval of the NDA; |
∎ |
may conclude that the drug substance or drug product manufacturing process is not in a state of control or does not meet cGMP or all the regulatory requirements; |
∎ |
may not be able to timely conduct the necessary pre-approval inspection or devote sufficient resources to NDA review on a timely basis due to the COVID-19 pandemic; |
∎ |
may change approval policies or adopt new regulations; or |
∎ |
may not file a submission due to, among other reasons, the content or formatting of the submission. |
∎ |
delays by us in reaching a consensus with regulatory agencies on trial design; |
∎ |
delays in reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and clinical trial sites; |
∎ |
delays in obtaining required Institutional Review Board, or IRB, approval at each clinical trial site; |
∎ |
delays in recruiting suitable patients to participate in clinical trials; |
∎ |
the effects of COVID-19 on our ability to recruit and retain patients, including as a result of changes to FDA guidance and policies relating to the conduct of clinical trials during the COVID-19 pandemic, potential heightened exposure to COVID-19, prioritization of hospital resources toward the outbreak and unwillingness by patients to enroll or comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services; |
∎ |
imposition of a clinical hold by regulatory agencies for any reason, including safety concerns or after an inspection of clinical operations or trial sites; |
∎ |
failure by CROs, other third parties or us to adhere to clinical trial requirements; |
∎ |
failure to perform clinical trials in accordance with the FDA’s good clinical practices, or GCP, or applicable regulatory guidelines in other countries; |
∎ |
delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites; |
∎ |
delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up, which we have experienced and believe may be caused by patients experiencing reduced symptoms or incidences of disease; |
∎ |
clinical trial sites or patients dropping out of a trial; |
∎ |
delays or interruptions to supply or failure to ensure compliance with cGMP or quality standards of our product candidates or the other product candidates in a combination product trial or other materials necessary to conduct clinical trials of our product candidates; |
∎ |
occurrence of adverse events in clinical trials that are associated with the product candidates that are viewed to outweigh their potential benefits; or |
∎ |
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols. |
∎ |
the FDA and other governmental health authorities, IRBs, or ethics committees may not authorize or may delay authorizing us or our investigators to commence or continue a clinical trial or conduct a clinical trial at all or at a prospective trial site, such as by requiring us to conduct additional nonclinical studies and to programs for our product candidates submit additional data or imposing other requirements before permitting us to initiate or continue a clinical trial; |
∎ |
we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
∎ |
clinical trials of our product candidates may produce negative or inconclusive results and we may decide, or regulators may require us, to conduct nonclinical studies in addition to those we currently have planned or additional clinical trials or we may decide to abandon drug development programs for our product candidates; |
∎ |
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; |
∎ |
our contractors, such as our CROs, clinical trial sites or investigators, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; |
∎ |
we may elect to, or regulators, IRBs or ethics committees may require that, we or our investigators, suspend or terminate clinical trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to health risks; |
∎ |
the cost of planned clinical trials of our product candidates may be greater than we anticipate; |
∎ |
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; |
∎ |
our third-party suppliers, such as our contract manufacturers of the POD device and our active ingredients, may not provide us with the information we need for our marketing submissions or may not manufacture product for us that is in compliance with regulatory requirements; and |
∎ |
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or IRBs or ethics committees to suspend or terminate the trials, or reports may arise from nonclinical or clinical testing of studies conducted by competitors that raise safety or efficacy concerns broadly about our POD technology, upper nasal cavity delivery or about our product candidates specifically. |
∎ |
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; |
∎ |
the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; |
∎ |
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies clinical trials or may refuse to accept data from nonclinical studies or clinical trials conducted in other geographies or jurisdictions; |
∎ |
data collected from clinical trials may not be sufficient to support the submission of an NDA, or other submission, or to obtain regulatory approval in the United States or elsewhere; |
∎ |
the FDA may determine that we cannot rely on the Section 505(b)(2) approval pathway for any of our product candidates, in which case we may be required to conduct additional clinical trials, provide additional data and information and meet additional standards for product approval, resulting in increased time and financial resources required to obtain FDA approval for our product candidates; |
∎ |
the FDA may determine that we have identified the wrong LD or LDs or that approval of a Section 505(b)(2) application for any of our product candidates is blocked by patent or non-patent exclusivity of the LD or LDs; |
∎ |
the FDA may require us to conduct additional clinical trials depending on the safety or exploratory efficacy data from our existing and planned future clinical trials; |
∎ |
we may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for our proposed indication is acceptable; |
∎ |
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications of third-party manufacturers with which we contract for clinical and commercial supplies; |
∎ |
we or any third-party manufacturers may be unable to demonstrate compliance with cGMP to the satisfaction of the FDA or comparable foreign regulatory authorities, which could result in delays in regulatory approval or require us to withdraw or recall product candidates and interrupt commercial supply of our product candidates; and |
∎ |
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
∎ |
we may be unable to obtain regulatory approval for our product candidates; |
∎ |
our clinical trials may be put on hold; |
∎ |
regulatory authorities may withdraw approvals of our product candidates or require additional nonclinical studies or clinical trials; |
∎ |
regulatory authorities may require additional warnings in the labeling; |
∎ |
regulatory authorities may require us to implement a REMS; |
∎ |
a medication guide outlining the risks of such side effects for distribution to patients may be required; |
∎ |
we could be sued and held liable for harm caused to patients; and |
∎ |
our reputation may suffer. |
∎ |
holds on clinical trials; |
∎ |
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls; |
∎ |
imposition of a REMS, which may include distribution or use restrictions; |
∎ |
requirements to conduct additional post-market clinical trials to assess the safety of the product; |
∎ |
revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; |
∎ |
manufacturing delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation; |
∎ |
fines, warning or untitled letters; |
∎ |
refusal by the FDA to approve pending applications or supplements to approved applications submitted by us, or withdrawal of product approvals; |
∎ |
product seizure or detention, or refusal to permit the import or export of product candidates; and |
∎ |
injunctions or the imposition of civil or criminal penalties. |
∎ |
the federal Anti-Kickback Statute, which prohibits, among other things, 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 health care program, such as the Medicare and Medicaid programs; |
∎ |
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from a federal health care program, such as Medicare, Medicaid, or other third-party payors that are false or fraudulent or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government; |
∎ |
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care 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 health care benefit program, regardless of the payor (e.g., 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, health care benefits, items or services relating to health care matters; |
∎ |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose requirements on certain covered health care providers, health plans, and health care clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization; |
∎ |
the federal physician self-referral law, commonly known as the Stark Law, which prohibits a physician from making a referral to an entity for certain designated health services reimbursed by Medicare or Medicaid if the physician or a member of the physician’s family has a financial relationship with the entity, and which also prohibits the submission of any claims for reimbursement for designated health services furnished pursuant to a prohibited referral; |
∎ |
the federal Physician Payments Sunshine Act, created under Section 6002 of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively, referred to as the ACA, and its implementing regulations 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 collect and report annually to the United States Department of Health and Human Services, or HHS, Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, including ownership and investment interests held by physicians and their immediate family members; beginning calendar year 2021, applicable manufacturers must collect information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse-midwives for reporting in 2022; |
∎ |
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; |
∎ |
federal government price reporting laws, changed by the ACA to, among other things, increase the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program and offer such rebates to additional populations, that require us to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our product candidates, increased infrastructure costs, and potentially limit our ability to offer certain marketplace discounts); |
∎ |
the Foreign Corrupt Practices Act, a United States law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals); and |
∎ |
state law equivalents and adjuncts to many of the above federal laws, such as anti-kickback, false claims, consumer protection, unfair competition, and privacy and data security laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submission of claims involving any of our product candidates or related health care services for reimbursement by any third-party payor, including public and commercial insurers; state laws that require biotech 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 health care providers; state laws that require drug manufacturers to file reports with states regarding marketing information, such as the tracking and reporting of gifts, compensation and other remuneration and items of value provided to health care professionals and entities (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business or increase enforcement scrutiny of our activities); state laws regarding the reporting of certain pricing information; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, with differing effects and obligations. |
∎ |
the efficacy and safety of our product candidates; |
∎ |
perceived advantages of our product candidates over alternative treatments, such as oral, IM and IV formulations; |
∎ |
the indications for which the product candidates are approved and the labeling approved by regulatory authorities for use with the product candidates, including any warnings, limitations or contraindications contained in a product’s approved labeling; |
∎ |
acceptance by physicians and patients of the product candidate as a safe and effective treatment; |
∎ |
the cost, safety and efficacy of treatment in relation to alternative treatments, including generic versions of the product candidates; |
∎ |
the extent to which our product candidates are included on formularies of hospitals and managed care organizations; |
∎ |
the availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities for the product candidates; |
∎ |
relative convenience and ease of administration of the product candidates; |
∎ |
the prevalence and severity of adverse side effects; |
∎ |
the timing of market introduction of competitive product; |
∎ |
restrictions on the distribution of our product candidates; |
∎ |
the effectiveness of our sales and marketing efforts; |
∎ |
unfavorable publicity relating to our product candidates; and |
∎ |
the approval of other new therapies for the same indications. |
∎ |
our inability to recruit, train and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel; |
∎ |
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any product candidates; |
∎ |
the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement and other acceptance by payors for our product candidates; |
∎ |
the inability to price our product candidates at a sufficient price point to ensure an adequate and attractive level of profitability; |
∎ |
restricted or closed distribution channels that make it difficult to distribute our product candidates to segments of the patient population; |
∎ |
the lack of complementary product candidates to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and |
∎ |
unforeseen costs and expenses associated with creating an independent commercialization organization. |
∎ |
a covered benefit under its health plan; |
∎ |
safe, effective and medically necessary; |
∎ |
appropriate for the specific patient; |
∎ |
cost-effective relative to other alternatives, including generic products; and |
∎ |
neither experimental nor investigational. |
∎ |
TRUDHESA |
∎ |
INP105 FDA-approved acute treatments for agitation and aggression in ASD, commonly prescribed treatments include mostly atypical (second generation) antipsychotics. These can include risperdone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel), aripiprazole (Abilify), ziprasidone (Geodon) and others. |
∎ |
INP107 MAO-B inhibitors, COM-T inhibitors, dopamine agonists, amantadine such as Gocovri, apomorphine and inhaled levodopa, such as Inbrija. In addition, there are several product candidates under development by pharmaceutical companies such as Eli Lilly & Co., Intec Pharma Ltd. and AbbVie Inc. Some of these product candidates also utilize alternative routes of administration, such as Sunovion Pharmaceuticals, Inc., whose product candidate uses a sublingual film, and Acorda Therapeutics, Inc. whose product candidate uses a dry powder inhaler. |
∎ |
our CMOs, or other third parties we rely on, may encounter difficulties in achieving the volume of production needed to satisfy commercial demand, may experience technical issues that impact quality or compliance with applicable and strictly enforced regulations governing the manufacture of pharmaceutical products, and may experience shortages of qualified personnel to adequately staff production operations; |
∎ |
our wholesalers and distributors could become unable to sell and deliver our product candidates for regulatory, compliance and other reasons; |
∎ |
our CMOs, wholesalers and distributors could breach or default on their agreements with us to meet our requirements for commercialization of our product candidates; |
∎ |
our CMOs, wholesalers and distributors may not perform as agreed or may not remain in business for the time required to successfully produce, store, sell and distribute our product candidates and we may incur additional cost; |
∎ |
our CMOs, wholesalers and distributors may misappropriate our proprietary information; and |
∎ |
if our CMOs, wholesalers and distributors were to terminate our arrangements or fail to meet their contractual obligations, we may be forced to delay our commercial programs. |
∎ |
others will not or may not be able to make, use or sell upper nasal cavity product candidates that are the same as or similar to our product candidates but that are not covered by the claims of the patents that we own; |
∎ |
we or our existing or future collaborators are the first to make the inventions covered by each of our issued patents and pending patent applications that we own; |
∎ |
we, or our existing or future collaborators, are the first to file patent applications covering certain aspects of our inventions; |
∎ |
others will not independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
∎ |
a third party will not challenge our patents and, if challenged, a court would hold that our patents are valid, enforceable and infringed; |
∎ |
any issued patents that we own or have licensed will provide us with any competitive advantages, or will not be challenged by third parties; |
∎ |
we may develop additional proprietary technologies that are patentable; |
∎ |
the patents of others will not have a material or adverse effect on our business, financial condition, results of operations and prospects; and |
∎ |
our competitors do not conduct research and development activities in countries where we do not have enforceable patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets. |
∎ |
injury to our reputation; |
∎ |
decreased demand for our product candidates or products that we may develop; |
∎ |
withdrawal of clinical trial participants; |
∎ |
costs to defend the related litigations; |
∎ |
a diversion of management’s time and our resources; |
∎ |
substantial monetary awards to trial participants or patients; |
∎ |
product recalls, withdrawals, or labeling, marketing or promotional restrictions; |
∎ |
loss of revenue; |
∎ |
the inability to successfully commercialize TRUDHESA and our other product candidates, if approved; and |
∎ |
a decline in our stock price. |
∎ |
our ability to successfully commercialize TRUDHESA; |
∎ |
receipt of marketing approval for our other product candidates; |
∎ |
results of nonclinical studies and clinical trials of our product candidates, or those of our competitors or our existing or future collaborators; |
∎ |
introductions and announcements of new product candidates by us, our future commercialization partners, or our competitors, and the timing of these introductions or announcements; |
∎ |
regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our product candidates; |
∎ |
material and adverse impact of the COVID-19 pandemic on the markets and the broader global economy; |
∎ |
the success of competitive products or technologies; |
∎ |
actions taken by regulatory agencies with respect to our product candidates, clinical trials, manufacturing process or sales and marketing terms; |
∎ |
actual or anticipated variations in our financial results or those of companies that are perceived to be similar to us; |
∎ |
the success of our efforts to acquire or in-license additional technologies, products or product candidates; |
∎ |
developments concerning any future collaborations, including but not limited to those with our sources of manufacturing supply and our commercialization partners; |
∎ |
market conditions in the life sciences and pharmaceutical sectors; |
∎ |
announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures or capital commitments; |
∎ |
developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our product candidates and products; |
∎ |
our ability or inability to raise additional capital and the terms on which we raise it; |
∎ |
the recruitment or departure of key personnel; |
∎ |
changes in the structure of healthcare payment systems; |
∎ |
actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally; |
∎ |
our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; |
∎ |
fluctuations in the valuation of companies perceived by investors to be comparable to us; |
∎ |
announcement and expectation of additional financing efforts; |
∎ |
speculation in the press or investment community; |
∎ |
trading volume of our common stock; |
∎ |
sales of our common stock by us or our stockholders; |
∎ |
the concentration in ownership of our common stock; |
∎ |
changes in accounting principles; |
∎ |
potential litigation or the threat thereof; |
∎ |
terrorist acts, acts of war or periods of widespread civil unrest; |
∎ |
natural disasters and other calamities; and |
∎ |
general economic, industry and market conditions. |
∎ |
establish a classified board of directors so that not all members of our board are elected at one time; |
∎ |
permit only the board of directors to establish the number of directors and fill vacancies on the board; |
∎ |
provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; |
∎ |
require super-majority voting to amend some provisions in our restated certificate of incorporation and restated bylaws; |
∎ |
authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan; |
∎ |
eliminate the ability of our stockholders to call special meetings of stockholders; |
∎ |
prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; |
∎ |
prohibit cumulative voting; and |
∎ |
establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings. |
∎ |
our ability to successfully execute our commercialization strategy for TRUDHESA; |
∎ |
our ability to maintain regulatory approval of TRUDHESA and to obtain and maintain regulatory approval of our other product candidates, and any related restrictions, limitations or warnings in the label of any approved product; |
∎ |
the timing or likelihood of regulatory filings and approvals; |
∎ |
the size and growth potential of the markets for TRUDHESA and our other product candidates, if approved for commercial use, and our ability to serve those markets; |
∎ |
the success, cost and timing of our development activities, preclinical studies and clinical trials; |
∎ |
the number, size and design of clinical trials that regulatory authorities may require to obtain marketing approval; |
∎ |
our plans relating to the future development and manufacturing of our product candidates, including plans for future development of our POD devices and plans to address additional indications for which we may pursue regulatory approval; |
∎ |
future agreements with third parties in connection with preclinical and clinical development as well as the manufacture and commercialization of TRUDHESA and our other product candidates, if approved for commercial use; |
∎ |
our ability to attract customers for any approved products; |
∎ |
the effect of litigation, complaints or adverse publicity on our business; |
∎ |
our ability to establish and expand our sales force to address effectively the new indications, geographies and types of organizations we intend to target; |
∎ |
our ability to forecast and maintain an adequate rate of revenue growth and appropriately plan our expenses; |
∎ |
our liquidity and working capital requirements; |
∎ |
our ability to attract and retain qualified employees and key personnel; |
∎ |
our ability to protect and enhance our brand and intellectual property; |
∎ |
the costs related to defending intellectual property infringement and other claims; |
∎ |
privacy, data security, and data protection laws, actual or perceived privacy or data breaches or other data security incidents, or the loss of data; |
∎ |
future regulatory, judicial, and legislative changes in our industry; |
∎ |
future arrangements with, or investments in, other entities or associations, products, services or technologies; |
∎ |
the adequacy of our financial resources following this offering to fund our operations; and |
∎ |
our use of the net proceeds from this offering. |
∎ |
an actual basis; and |
∎ |
an adjusted basis, giving effect to the sale of 3,000,000 shares of common stock in this offering, based upon an assumed public offering price of $18.65 per share, which is the last reported sale price of our common stock on the Nasdaq Global Market on September 3, 2021, after deducting the estimated underwriting discounts and commissions and estimated offering expenses. |
As of June 30, 2021 |
||||||||
Actual |
As Adjusted(1) |
|||||||
(in thousands, except share and per share data) |
||||||||
(Unaudited) |
||||||||
Cash and cash equivalents |
$ | 60,948 | $ | 112,781 | ||||
|
|
|
|
|||||
Long-term debt |
$ | 8,857 | $ | 8,857 | ||||
Stockholders’ equity: |
||||||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding, actual; 10,000,000 shares authorized, no shares issued and outstanding, as adjusted |
– | – | ||||||
Common stock, $0.001 par value; 300,000,000 shares authorized; 19,470,914 shares issued and outstanding, actual; 300,000,000 shares authorized, 22,470,914 shares issued and outstanding, as adjusted |
19 | 22 | ||||||
Additional paid-in capital |
216,314 | 268,144 | ||||||
Accumulated deficit |
(165,035 | ) | (165,035 | ) | ||||
|
|
|
|
|||||
Total stockholders’ equity |
51,298 | 103,131 | ||||||
|
|
|
|
|||||
Total capitalization |
$ | 60,155 | $ | 111,988 | ||||
|
|
|
|
(1) | The as adjusted information is illustrative only and will change based on the actual public offering price and other terms of this offering as determined at pricing. Each $1.00 increase (decrease) in the assumed public offering price of $18.65 per share, which is the last reported sale price of our common stock on the Nasdaq Global Market on September 3, 2021, would increase (decrease) each of our as adjusted cash, additional paid-in-capital, paid-in-capital, |
∎ |
2,770,785 shares of common stock issuable upon the exercise of options outstanding as of June 30, 2021, with a weighted-average exercise price of $6.25 per share; |
∎ |
621,010 shares of our common stock issuable upon the exercise of stock options granted after June 30, 2021, with a weighted-average exercise price of $12.48 per share; |
∎ |
71,522 shares of our common stock issuable upon the exercise of warrants issued after June 30, 2021, with an exercise price of $8.389 per share; and |
∎ |
2,449,021 shares of common stock reserved for future issuance under our stock-based compensation plans as of June 30, 2021, consisting of (i) 2,173,021 shares of common stock reserved for future issuance under our 2021 Equity Incentive Plan as of June 30, 2021 and (ii) 276,000 shares of common stock reserved for future issuance under our 2021 Employee Stock Purchase Plan. |
Assumed public offering price per share |
$ | 18.65 | ||||||
Historical net tangible book value per share as of June 30, 2021 |
$ | 2.63 | ||||||
Increase in net tangible book value per share attributable to new investors participating in this offering |
1.96 | |||||||
|
|
|||||||
As adjusted net tangible book value per share after this offering |
4.59 | |||||||
|
|
|||||||
Dilution in as adjusted net tangible book value per share to new investors in this offering |
$ | 14.06 | ||||||
|
|
∎ |
2,770,785 shares of common stock issuable upon the exercise of options outstanding as of June 30, 2021, with a weighted-average exercise price of $6.25 per share; |
∎ |
621,010 shares of our common stock issuable upon the exercise of stock options granted after June 30, 2021, with a weighted-average exercise price of $12.48 per share; |
∎ |
71,522 shares of our common stock issuable upon the exercise of warrants issued after June 30, 2021, with an exercise price of $8.389 per share; and |
∎ |
2,449,021 shares of common stock reserved for future issuance under our stock-based compensation plans as of June 30, 2021, consisting of (i) 2,173,021 shares of common stock reserved for future issuance under our 2021 Equity Incentive Plan as of June 30, 2021 and (ii) 276,000 shares of common stock reserved for future issuance under our 2021 Employee Stock Purchase Plan. |
∎ |
the phases of development of our product candidates; |
∎ |
the progress and results of our research and development activities; |
∎ |
the number of trials required for regulatory approval of our product candidates; |
∎ |
the number of sites included in the trials; |
∎ |
the countries in which the trials are conducted; |
∎ |
the length of time required to enroll eligible subjects and initiate clinical trials; |
∎ |
the number of subjects that participate in the trials; |
∎ |
the drop-out and discontinuation rate of subjects; |
∎ |
potential additional safety monitoring requested by regulatory agencies; |
∎ |
the duration of subject participation in the trials and follow-up; |
∎ |
the cost and timing of manufacturing of our product candidates; |
∎ |
the receipt of regulatory approvals from applicable regulatory authorities; |
∎ |
the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; |
∎ |
the hiring and retention of research and development personnel; |
∎ |
the impact of the COVID-19 pandemic or other future pandemics on timelines and clinical operations, which may lead to increased costs, delays or both; and |
∎ |
the extent to which we establish collaboration, licensing or similar arrangements and the performance of any related third parties. |
Six Months Ended June 30, |
|
|||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 10,174 | $ | 13,391 | $ | (3,217 | ) | |||||
General and administrative |
14,633 | 9,374 | 5,259 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
24,807 | 22,765 | 2,042 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(24,807 | ) | (22,765 | ) | (2,042 | ) | ||||||
|
|
|
|
|
|
|||||||
Other (expense) income, net |
(1,966 | ) | 84 | (2,050 | ) | |||||||
Loss before income taxes |
(26,773 | ) | (22,681 | ) | (4,092 | ) | ||||||
Provision for income taxes |
— | — | — | |||||||||
|
|
|
|
|
|
|||||||
Net loss and comprehensive loss |
$ | (26,773 | ) | $ | (22,681 | ) | $ | (4,092 | ) | |||
|
|
|
|
|
|
Six Months Ended June 30, |
||||||||||||
2021 |
2020 |
Change |
||||||||||
(in thousands) |
||||||||||||
Program-specific costs: |
||||||||||||
TRUDHESA |
$ | 3,240 | $ | 6,943 | $ | (3,703 | ) | |||||
INP105 |
686 | 170 | 516 | |||||||||
Other programs |
28 | 297 | (269 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total program-specific costs |
$ | 3,954 | $ | 7,410 | $ | (3,456 | ) | |||||
|
|
|
|
|
|
|||||||
Non program-specific costs: |
||||||||||||
Personnel-related |
$ | 5,256 | $ | 4,935 | $ | 321 | ||||||
Internal, overhead and other expenses |
964 | 1,046 | (82 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total non program-specific costs |
6,220 | 5,981 | 239 | |||||||||
|
|
|
|
|
|
|||||||
Total research and development expenses |
$ | 10,174 | $ | 13,391 | $ | (3,217 | ) | |||||
|
|
|
|
|
|
Year Ended December 31, |
Change |
|||||||||||
2020 |
2019 |
|||||||||||
(in thousands) |
||||||||||||
Operating expenses: |
||||||||||||
Research and development |
$ | 27,285 | $ | 28,812 | $ | (1,527 | ) | |||||
General administrative |
18,049 | 12,754 | 5,295 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
45,334 | 41,566 | 3,768 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(45,334 | ) | (41,566 | ) | (3,768 | ) | ||||||
Other expense, net |
(463 | ) | (263 | ) | (200 | ) | ||||||
|
|
|
|
|
|
|||||||
Loss before income taxes |
(45,797 | ) | (41,829 | ) | (3,968 | ) | ||||||
Provision for income taxes |
(1 | ) | (30 | ) | 29 | |||||||
|
|
|
|
|
|
|||||||
Net loss and comprehensive loss |
(45,798 | ) | (41,859 | ) | (3,939 | ) | ||||||
Accretion on redeemable convertible preferred stock |
(518 | ) | (505 | ) | (13 | ) | ||||||
|
|
|
|
|
|
|||||||
Net loss attributable to common stockholders |
$ | (46,316 | ) | $ | (42,364 | ) | $ | (3,952 | ) | |||
|
|
|
|
|
|
Year Ended December 31, |
|
|||||||||||
2020 |
2019 |
Change |
||||||||||
(in thousands) |
||||||||||||
Program-specific costs: |
||||||||||||
TRUDHESA |
$ | 15,961 | $ | 17,199 | $ | (1,238 | ) | |||||
INP105 |
222 | 1,759 | (1,537 | ) | ||||||||
INP107(1) |
82 | 1,242 | (1,160 | ) | ||||||||
Other programs |
55 | 102 | (47 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total program-specific costs |
16,320 | 20,302 | (3,982 | ) | ||||||||
|
|
|
|
|
|
|||||||
Non program-specific costs: |
||||||||||||
Personnel-related |
9,701 | 7,599 | 2,102 | |||||||||
Cost reimbursements and credits |
(47 | ) | (227 | ) | 180 | |||||||
Internal, overhead and other expenses |
1,311 | 1,138 | 173 | |||||||||
|
|
|
|
|
|
|||||||
Total non program-specific costs |
10,965 | 8,510 | 2,455 | |||||||||
|
|
|
|
|
|
|||||||
Total research and development expenses |
$ | 27,285 | $ | 28,812 | $ | (1,527 | ) | |||||
|
|
|
|
|
|
(1) | Includes expenditures relating to a levodopa-only formulation, prior to our decision to move INP107 forward in clinical development. |
Year Ended December 31, |
Six Months Ended June 30, |
|||||||||||||||
2020 |
2019 |
2021 |
2020 |
|||||||||||||
(in thousands) |
||||||||||||||||
Cash used in operating activities |
$ | (39,183 | ) | $ | (36,487 | ) | $ | (25,944 | ) | $ | (19,320 | ) | ||||
Cash used in investing activities |
(1,782 | ) | (1,523 | ) | (116 | ) | (818 | ) | ||||||||
Cash provided by financing activities |
11,059 | 21 | 79,913 | 26 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net increase (decrease) in cash |
$ | (29,906 | ) | $ | (37,989 | ) | $ | 53,853 | $ | (20,112 | ) | |||||
|
|
|
|
|
|
|
|
∎ |
the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for TRUDHESA or any of our product candidates for which we receive marketing approval; |
∎ |
the costs, timing and outcome of regulatory review of our product candidates; |
∎ |
the number and development requirements of other product candidates that we may pursue; |
∎ |
the costs associated with building out our operations; |
∎ |
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; |
∎ |
our ability to establish strategic collaborations; |
∎ |
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; |
∎ |
the risk/benefit profile, cost and reimbursement policies with respect to TRUDHESA and our other product candidates, if approved, and existing and potential future therapies that compete with our product candidates; and |
∎ |
the costs associated with being a public company. |
∎ |
Expected Term. mid-point between the vesting date and the end of the contractual term) to determine the expected term. |
∎ |
Expected Volatility |
∎ |
Risk-Free Interest Rate |
∎ |
Expected Dividend |
∎ |
Rapid Onset. |
∎ |
Consistent Drug Bioavailability |
∎ |
Improved Patient-Provider Experience |
∎ |
Manufacturability co-formulating our therapeutics inside of a pressurized propellant canister. |
∎ |
Formulation Versatility |
∎ |
Strong Intellectual Property Position ex-U.S. jurisdictions directed to our approach of drug delivery to the upper nasal cavity, including claims directed to a nasal device with separate drug and propellant compartments. Our patent portfolio is expected to provide patent protection ranging from 2032 to 2040. |
∎ |
38% of patients were pain free at two hours after their first dose of TRUDHESA. |
∎ |
52% of patients receiving TRUDHESA were free of their most bothersome migraine symptom at two hours. |
∎ |
Patients treated with TRUDHESA also demonstrated improvement in pain relief: 16% of patients treated with TRUDHESA had pain relief within 15 minutes of treatment, and 66% had pain relief within two hours. |
∎ |
38% of patients treated with TRUDHESA remained pain free at two hours through three months of treatment and 34% of patients treated with TRUDHESA remained pain free at two hours through six months of treatment. |
∎ |
Patients who received TRUDHESA saw a 48% reduction in the frequency of their migraines compared to baseline during the six-month trial. |
∎ |
93% and 86% of patients achieving pain freedom at two hours on TRUDHESA did not suffer a relapse in migraine or require a rescue medication at 24 hours and 48 hours, respectively. |
∎ |
EAER data showed a meaningful reduction in the usage of healthcare resources by patients treated with TRUDHESA versus their baseline. Emergency room visits were reduced by approximately 73% and hospitalizations and urgent care visits were reduced by 100%. |
∎ |
Successfully commercialize TRUDHESA for the acute treatment of migraine non-personal promotion to all targeted and non-targeted medium value physicians. To capture the maximum commercial opportunity of TRUDHESA, we may also selectively seek partners to commercialize the product outside of our target markets, including additional penetration within the broader primary care setting, as well as in geographies outside of the United States. |
∎ |
Rapidly advance INP105 through clinical development for the acute treatment of agitation and aggression associated with ASD on-demand therapy for the safe and rapid treatment of agitation and aggression events in patients with ASD. Based on the positive clinical data generated to date, INP105’s rapid onset of action and non-invasive delivery, we believe it is well positioned to expand the treatment setting beyond the emergency department to administration in in-patient treatment facilities and patients’ homes by parents or caregivers. We believe INP105 has the potential to reduce emergency room visits for the approximately 220,000 ASD patients in the United States that we estimate seek care due to mental health issues annually. We plan to initiate a double-blind, placebo-controlled Phase 2 proof-of-concept |
∎ |
Maximize the therapeutic and commercial potential of our proprietary POD technology platform |
outcomes. In doing so, we may elect to enter into collaborations for third-party product candidates for which we believe that our technologies and expertise may be valuable. |
∎ |
Expand applications of our existing product candidates. follow-on indications and in patient populations where our product candidates can deliver meaningful clinical impact, and we have a clear clinical and regulatory approval pathway and that we believe we can commercialize successfully, if approved. |
∎ |
Independently develop and commercialize product candidates in indications and geographies where we believe we can maximize value. in-house discipline with respect to our development and commercialization efforts. We have a disciplined strategy to maximize the value of our pipeline by retaining development and commercialization rights to those product candidates, indications and geographies that we believe we can ultimately commercialize successfully on our own if they are approved. We plan to collaborate on product candidates that we believe have promising utility in disease areas or patient populations that are better served by the resources or specific expertise of other biopharmaceutical companies. |
POD Technology |
Traditional Nasal Pump | |
|
|
Potential Advantages of Upper Nasal Cavity Delivery ∎ Rapid uptake into the blood stream∎ Decreased dripping and swallowing∎ Consistent dosing and distribution |
∎ |
Dose Consistency |
∎ |
Biphasic Spray |
∎ |
Narrow Plume Geometry two-to-three |
∎ |
Reduces Human Error |
∎ |
Separated Drug and Propellant |
∎ |
Unmet Need for Efficacy |
∎ |
Need for More Rapid Onset |
∎ |
Need for Longer Duration of Effect |
∎ |
Opportunity for Improved Tolerability Profile |
∎ |
Need for More Convenient and Consistent Dosing. |
∎ |
Opportunity for an Improved Tolerability Profile Compared to Intravenous Administration. |
∎ |
Rapid Onset |
∎ |
Long-lasting 5-HT1B and 5HT-1D. In our Phase 1 clinical trial, TRUDHESA was observed to have similar blood levels of DHE compared to IV DHE from measurements at 20-minute through 48-hour. |
∎ |
Broad Target Population |
∎ |
Convenient and Consistent Delivery. non-injectable, with the DHE dose delivered in 3/10ths of a second with minimal coordination from the patient. TRUDHESA has demonstrated more consistent blood levels than traditional nasal spray, yielding improved blood levels and a lower coefficient of variance with doses. Further, in our STOP301 trial, 84% of trial participants agreed or strongly agreed with the statement that TRUDHESA was “easy to use” and preferred it over their current therapy. |
∎ |
Low Incidence of Side Effects. |
∎ |
Reducing the Need for Additional Healthcare Resources for Acute Treatment of Migraines |
∎ |
treatment emergent adverse events, or TEAEs; |
∎ |
change in nasal mucosa as measured by focused, endoscopic nasal exams conducted by an ear, nose and throat physician following the Nasal Examination Manual; and |
∎ |
change in olfactory function as assessed by the University of Pennsylvania Smell Identification Test. |
Migranal (2mg) |
TRUDHESA (1.45mg) |
D.H.E.45 IV (1mg) |
||||||||||
AUC0-inf (pg*hr/ml) [%CV] |
2,199 [75%] | 6,275 [42%] | 7,490 [17%] | |||||||||
Cmax (pg/ml) [%CV] |
300 [92%] | 1,301 [51%] | 14,190 [37%] | |||||||||
Tmax, median (min) [%CV] |
47 [59%] | 30 [57%] | 5 [118%] | |||||||||
AUC0-2 (hr*pg/ml) |
388 | 1,603 | 3,022 |
∎ |
Olanzapine for Agitation and Aggression |
∎ |
Rapid Onset of Action |
∎ |
Non-invasive Deliverynon-invasive therapy helps secure the patient-caregiver trust and improve overall outcome for the patient by enabling the provider to intervene earlier during a period of agitation and/or aggression. INP105 utilizes our proprietary POD technology to deliver olanzapine to the upper nasal cavity in less than a 3/10th of a second with the push of a button. We believe it is well positioned to expand the treatment setting beyond the emergency department to administration in in-patient treatment facilities and patients’ homes by parents or caregivers. |
∎ |
Manageable Tolerability Profile |
∎ |
Potential to avoid side effects associated with chronic treatment. |
Olanzapine 5 mg IM n=20 |
Olanzapine 10 mg IM n=2 |
Olanzapine ODT 10 mg n=18 |
POD-OLZ 5 mg n=10 |
POD-OLZ 10 mg n=9 |
POD-OLZ 15 mg n=8 |
POD- Placebon=10 | ||||||||
No. with at least one treatment related TEAE |
18 | 2 | 15 | 8 | 6 | 6 | 1 | |||||||
(90%) | (100%) | (83%) | (80%) | (67%) | (75%) | (10%) | ||||||||
Dizziness + postural dizziness |
10 | 2 | 8 | 3 | 3 | 1 | 0 | |||||||
(50%) | (100%) | (44%) | (30%) | (33%) | (13%) | (0%) | ||||||||
Presyncope (lightheadedness) |
1 | 0 | 1 | 0 | 1 | 1 | 0 | |||||||
(5%) | (0%) | (6%) | (0%) | (11%) | (13%) | (0%) | ||||||||
Hypotension + orthostatic hypotension |
4 | 2 | 2 | 1 | 2 | 2 | 0 | |||||||
(20%) | (100%) | (11%) | (10%) | (22%) | (25%) | (0%) |
∎ |
Delayed and Variable Levodopa Clinical Effect |
∎ |
Reduced Absorption and Food Effect |
∎ |
Challenges with Swallowing |
∎ |
Route of Administration 30-second inhalation process. Oral levodopa, due to its route of administration, has significant GI delays and may have variability in absorption. |
∎ |
Requires a Baseline of Carbidopa/Levodopa |
∎ |
Rapid Onset and Pronounced Effect |
∎ |
Self or Caregiver Administration |
∎ |
Delivery Without Breathing Coordination |
∎ |
Potential Treatment of Morning OFF |
∎ |
Alternative to Oral Carbidopa/Levodopa Dosing |
∎ |
TRUDHESA |
∎ |
INP105 FDA-approved acute treatments for agitation and aggression in ASD, commonly prescribed treatments include mostly atypical (second generation) antipsychotics. These can include risperdone (Risperdal), olanzapine (Zyprexa), quetiapine (Seroquel), aripiprazole (Abilify), ziprasidone (Geodon) and others. |
∎ |
INP107 MAO-B inhibitors, COM-T inhibitors, dopamine agonists, amantadine such as Gocovri, apomorphine and inhaled levodopa, such as Inbrija. In addition, there are several product candidates under development by pharmaceutical companies such as Eli Lilly & Co., Intec Pharma Ltd. and AbbVie Inc. Some of these product candidates also utilize alternative routes of administration, such as Sunovion Pharmaceuticals, Inc., whose product candidate uses a sublingual film, and Acorda Therapeutics, Inc. whose product candidate uses a dry powder inhaler. |
Name |
Age |
Position | ||||
Executive Officers: |
||||||
Adrian Adams |
70 | President, Chief Executive Officer and Chair | ||||
John Hoekman, Ph.D. |
40 | Chief Technology and Development Officer | ||||
John Leaman, M.D. |
48 | Chief Financial Officer | ||||
Stephen Shrewsbury, M.B. ChB. |
64 | Chief Medical Officer | ||||
Leonard S. Paolillo |
43 | Chief Commercial Officer | ||||
Non-Employee Directors: |
||||||
David Allison, Ph.D.(2)(3)(4) |
39 | Director | ||||
Timothy S. Nelson(2) |
57 | Director | ||||
H. Stewart Parker(1)(3) |
65 | Director | ||||
Ali Satvat(3) |
43 | Director | ||||
Mahendra G. Shah, Ph.D.(1)(2) |
76 | Director | ||||
Diane E. Wilfong(1) |
59 | Director |
(1) | Member of the Audit Committee. |
(2) | Member of the Compensation Committee. |
(3) | Member of the Nominating and Governance Committee. |
(4) | Lead Independent Director |
∎ |
the Class I directors are Mahendra G. Shah, Ph.D. and H. Stewart Parker and their terms will expire at our first annual meeting of stockholders held in 2022; |
∎ |
the Class II directors are David Allison, Ph.D. and Ali Satvat and their terms will expire at our second annual stockholders meeting to be held in 2023; and |
∎ |
the Class III directors are Adrian Adams, Timothy S. Nelson and Diane E. Wilfong and their terms will expire at our third annual stockholders meeting to be held in 2024. |
∎ |
selecting and hiring our independent registered public accounting firm; |
∎ |
the qualifications, independence and performance of our independent auditors; |
∎ |
the preparation of the audit committee report to be included in our annual proxy statement; |
∎ |
our compliance with legal and regulatory requirements; |
∎ |
our accounting and financial reporting processes, including our financial statement audits and the integrity of our financial statements; and |
∎ |
reviewing and approving related-person transactions. |
∎ |
evaluating, recommending, approving and reviewing executive officer compensation arrangements, plans, policies and programs; |
∎ |
evaluating and recommending non-employee director compensation arrangements for determination by our board of directors; |
∎ |
administering our cash-based and equity-based compensation plans; and |
∎ |
overseeing our compliance with regulatory requirements associated with the compensation of directors, officers and employees. |
∎ |
identifying, considering and recommending candidates for membership on our board of directors; |
∎ |
overseeing the process of evaluating the performance of our board of directors; and |
∎ |
advising our board of directors on other corporate governance matters. |
Name |
Fees Earned or Paid in Cash(1) |
Option Awards(3) |
All Other Compensation |
Total |
||||||||||||
David Allison, Ph.D. |
– | – | – | – | ||||||||||||
Robert Mittendorff, M.D. |
– | – | – | – | ||||||||||||
Timothy S. Nelson |
$ | 30,000 | – | $ | 78,000 | (2) | $ | 108,000 | ||||||||
H. Stewart Parker |
$ | 40,000 | – | – | $ | 40,000 | ||||||||||
Aaron Royston, M.D. |
– | – | – | – | ||||||||||||
Ali Satvat |
– | – | – | – | ||||||||||||
Mahendra G. Shah, Ph.D. |
– | – | – | – | ||||||||||||
Diane E. Wilfong. |
$ | 30,000 | – | – | $ | 30,000 |
(1) | The amounts reported in this column represent fees earned for service on our board of directors. |
(2) | In 2020, Mr. Nelson received $78,000 pursuant to his consulting agreement with us, pursuant to which he provides strategic business consulting services. |
(3) | The following table sets forth the aggregate number of shares of our common stock subject to outstanding options held by our non-employee directors as of December 31, 2020: |
Name |
Number of Shares Underlying Options Held as of December 31, 2020 |
|||
David Allison, Ph.D.. |
– | |||
Robert Mittendorff, M.D. |
– | |||
Timothy S. Nelson |
99,197 | (a) | ||
H. Stewart Parker |
74,843 | (b) | ||
Aaron Royston, M.D. |
– | |||
Ali Satvat |
– | |||
Mahendra G. Shah, Ph.D. |
– | |||
Diane E. Wilfong |
31,356 | (c) |
(a) | This amount reflects (i) options to purchase 12,303 shares, 1/4 th of which vested on February 14, 2018, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter, (ii) options to purchase 61,516 shares, all of which are vested, (iii) options to purchase 3,053 shares, 1/4th of which vested on February 13, 2019, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter and (iv) options to purchase 22,325 shares, 1/4th of which vested on February 8, 2020, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter. |
(b) | This amount reflects (i) options to purchase 6,107 shares, all of which are vested, (ii) options to purchase 12,214 shares, all of which are vested, (iii) options to purchase 18,627 shares, 1/4 th of which vested on March 9, 2018, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter, (iv) options to purchase 10,688 shares, 1/4th of which vested on February 13, 2019, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter and (v) options to purchase 27,207 shares, 1/4th of which vested on February 8, 2020, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter. In May 2019, our board of directors approved an amendment to Ms. Parker’s options referenced in clauses (iii), (iv) and (v) above, such that these options became fully vested upon our IPO. |
(c) | This amount reflects options to purchase 31,356 shares, 1/4 th of which vested on September 20, 2020, the one-year anniversary of the vesting commencement date, and 1/48th of which vest monthly thereafter. |
∎ |
Non-Executive Board Chairperson: $35,000 |
∎ |
Lead Director: $25,000 |
∎ |
Audit Committee Chair: $15,000 |
∎ |
Audit Committee Member (Non-Chair): $7,500 |
∎ |
Compensation Committee Chair: $12,000 |
∎ |
Compensation Committee Member (Non-Chair): $6,000 |
∎ |
Nominating and Corporate Governance Committee Chair: $10,000 |
∎ |
Nominating and Corporate Governance Committee Member (Non-Chair): $5,000 |
Name and Principal Position |
Salary ($) |
Option Awards($)(1) |
Non-Equity Incentive Plan Compensation ($)(2) |
All Other Compensation ($) |
Total ($) |
|||||||||||||||
Adrian Adams President & Chief Executive Officer |
266,041 | 3,348,910 | 95,544 | (3) | 15,330 | (4) | 3,725,825 | |||||||||||||
Jon Congleton(5) Former President & Chief Executive Officer |
173,548 | – | – | 1,924,378 | (6) | 2,097,926 | ||||||||||||||
John Leaman, M.D. Chief Financial Officer |
415,231 | – | 123,463 | – | 538,694 | |||||||||||||||
Stephen Shrewsbury, M.B. Ch B. Chief Medical Officer |
361,526 | – | 112,163 | 44,839 | (7) | 518,528 |
(1) | Amounts represent the aggregate grant date fair value of the stock options awarded to the named executive officer during 2020 in accordance with FASB Accounting Standards Codification Topic 718. The assumptions used in calculating the grant date fair value of the stock options reported in the Option Awards column are set forth in Note 9 of the notes to our financial statements included in this prospectus. Such grant-date fair market value does not take into account any estimated forfeitures related to service-based vesting conditions. |
(2) | The amounts reported reflect the annual performance-based cash bonus amounts awarded to our named executive officers for their service in 2020. For additional information regarding the non-equity incentive plan compensation, see “—Non-Equity Incentive Plan Awards.” |
(3) | Mr. Adams declined in full the non-equity incentive plan compensation he was entitled to for 2020. |
(4) | This amount reflects the compensation that Mr. Adams received for his service as a non-employee director prior to his appointment as our President and Chief Executive Officer as set forth in the “2020 Director Compensation Table” contained elsewhere in this prospectus. Since becoming our Chief Executive Officer, Mr. Adams has not received any compensation in his capacity as a director. |
(5) | Mr. Congleton resigned as our President and Chief Executive Officer effective May 4, 2020. |
(6) | This amount reflects (i) the payments Mr. Congleton received or will receive in connection with his resignation as our Chief Executive Officer, which included (A) an aggregate severance amount of $433,102, which is being paid monthly for a period of 12 months from May 12, 2020, (B) a lump sum payment to be paid in 2021 of $59,329, which is equal to his target bonus for 2020, as pro-rated for his period of service in 2020, (C) payments by us for premiums required to maintain his healthcare insurance for up to 12 months, the aggregate cost of which we estimate will be $26,455 (which is based on the payment of COBRA premiums after Mr. Congleton’s termination date starting June 2020 through December 2020 in the aggregate amount of $15,114, and the estimated payment of monthly COBRA premiums of $2,268 per month for the remaining 5 months), and (D) full acceleration of a portion of Mr. Congleton’s previously granted options, with an incremental value of $1,393,209, (ii) $3,259 for travel, (iii) $361 for internet services, (iv) $5,054 for rental housing expenses paid on behalf of Mr. Congleton, whose residence is in Pennsylvania, in conjunction with his regular duties in our Seattle, Washington corporate offices, and (v) $3,609 for moving costs. |
(7) | This amount reflects (i) our matching contributions of $8,839 made on behalf of Dr. Shrewsbury under our 401(k) plan and (ii) $36,000 for living expenses paid to Dr. Shrewsbury. |
Option Awards |
||||||||||||||||||||||||
Name |
Grant Date(1) |
Vesting Commencement Date |
Number of Securities Underlying Unexercised Options Exercisable |
Number of Securities Underlying Unexercised Options Unexercisable |
Option Exercise Price ($/share) |
Option Expiration Date |
||||||||||||||||||
Adrian Adams |
1/23/2020 | (2) | 1/8/2020 | – | 58,812 | $ | 8.19 | 1/23/2030 | ||||||||||||||||
5/4/2020 | (2) | 5/4/2020 | – | 715,358 | (3) | 7.86 | 5/4/2030 | |||||||||||||||||
John Leaman, M.D.(5) |
6/24/2019 | (4) | 6/24/2019 | 88,190 | 146,983 | 6.72 | 6/23/2029 |
Option Awards |
||||||||||||||||||||||||
Name |
Grant Date(1) |
Vesting Commencement Date |
Number of Securities Underlying Unexercised Options Exercisable |
Number of Securities Underlying Unexercised Options Unexercisable |
Option Exercise Price ($/share) |
Option Expiration Date |
||||||||||||||||||
Stephen Shrewsbury, M.B., Ch.B. |
2/14/2017 | (4) | 2/14/2017 | 23,580 | 1,026 | 1.97 | 2/14/2027 | |||||||||||||||||
10/18/2017 | (4) | 9/1/2017 | 12,008 | 2,772 | 1.97 | 10/18/2027 | ||||||||||||||||||
3/9/2018 | (4) | 2/13/2018 | 3,676 | 1,515 | 2.46 | 3/9/2028 | ||||||||||||||||||
2/8/2019 | (4) | 2/8/2019 | 38,290 | 45,251 | 2.95 | 2/7/2029 |
(1) | Outstanding equity awards granted prior to November 30, 2018, the effective date of our 2018 Equity Incentive Plan, were granted under our 2008 Equity Incentive Plan. |
(2) | 1/4 th of the option will vest on the one-year anniversary of the vesting commencement date and an additional 1/48th will vest monthly thereafter. |
(3) | On May 4, 2020, our board of directors approved the grant of Mr. Adams’ options, which also provided for (i) full vesting acceleration upon an involuntary termination within 12 months following a change in control or (ii) if an involuntary termination occurs prior to a change in control, vesting acceleration as to the number of then-unvested shares subject to the option which would have vested in the 12-month period following termination had Mr. Adams remained as our chief executive officer. |
(4) | 1/4 th of the option vested on the one-year anniversary of the vesting commencement date and an additional 1/48th vests monthly thereafter. |
(5) | On October 30, 2019, our board of directors approved an amendment of Dr. Leaman’s options granted on June 24, 2019 to provide for full vesting acceleration upon an involuntary termination within 12 months following a change in control. |
∎ |
shares subject to awards granted under our 2008 Plan and/or 2018 Plan, or the Prior Plans, that cease to be subject to such awards by forfeiture or otherwise after the effective date; |
∎ |
shares issued under our Prior Plans before or after the effective date pursuant to the exercise of stock options that are forfeited after the effective date; |
∎ |
shares issued pursuant to outstanding awards under our Prior Plans that are forfeited or repurchased by us at the original issue price after the effective date of the 2021 Plan; |
∎ |
shares subject to options or other awards under the Prior Plans that are used to pay the exercise price of an option or withheld to satisfy the tax withholding obligations related to any award; |
∎ |
shares subject to issuance upon exercise of an option or SAR granted under the 2021 Plan but which cease to be subject to the option or SAR for any reason other than exercise of the option or SAR; |
∎ |
shares subject to outstanding awards under our 2021 Plan that are forfeited or repurchased by us at the original issue price; |
∎ |
shares subject to awards under our 2021 Plan that otherwise terminate without such shares being issued; and |
∎ |
shares subject to awards under our 2021 Plan that are surrendered pursuant to an exchange program. |
∎ |
any breach of the director’s duty of loyalty to us or our stockholders; |
∎ |
any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
∎ |
unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or |
∎ |
any transaction from which the director derived an improper personal benefit. |
∎ |
we have been or are to be a participant; |
∎ |
the amounts involved exceeded or will exceed $120,000; and |
∎ |
any of our directors, executive officers or holders of more than 5% of our capital stock, or an affiliate or immediate family member of the foregoing persons, had or will have a direct or indirect material interest. |
Name of Stockholder |
Shares of Series D Redeemable Convertible Preferred Stock |
Total Purchase Price |
||||||
Norwest Venture Partners XIV, LP(1) |
35,256,206 | $ | 24,999,999 | |||||
KKR Iris Investors LLC(2) |
42,307,448 | 30,000,000 | ||||||
Entities affiliated with Vivo Capital LLC(3) |
5,876,033 | 4,166,666 | ||||||
venBio Global Strategic Fund II, L.P.(4) |
5,876,034 | 4,166,666 | ||||||
5AM Ventures V, L.P.(5) |
5,876,034 | 4,166,666 |
(1) | Norwest Venture Partners XIV, LP, or Norwest Venture Partners, holds more than 5% of our outstanding capital stock. NVP Associates, LLC is the managing member of Genesis VC Partners XIV, LLC, which is the general partner of Norwest Venture Partners. Robert Mittendorff, M.D., was a member of our board of directors until our IPO and was a partner at Norwest Venture Partners from 2012 until March 2021. Dr. Mittendorff currently serves as a consultant to Norwest Venture Partners. |
(2) | KKR Iris Investors LLC, or KKR Iris, holds more than 5% of our outstanding capital stock. Ali Satvat, a member of our board of directors, is a partner at Kohlberg Kravis Roberts & Co. L.P. |
(3) | Consists of shares purchased by Vivo Capital Fund VIII, L.P., or Vivo VIII, and Vivo Capital Surplus Fund VIII, L.P., or Vivo Surplus, which collectively hold more than 5% of our outstanding capital stock. Vivo Capital VIII, LLC is the general partner of Vivo VIII and Vivo Surplus. Mahendra Shah, Ph.D., a member of our board of directors, is a managing director at Vivo Capital LLC, an affiliate of Vivo Capital VIII, LLC. |
(4) | venBio Global Strategic Fund II, L.P., or venBio Strategic Fund, holds more than 5% of our outstanding capital stock. Aaron Royston, M.D., was a member of our board of directors until our IPO and is a partner at venBio Partners LLC, an affiliate of venBio Strategic Fund. |
(5) | 5AM Ventures V, L.P., or 5AM Ventures, holds more than 5% of our outstanding capital stock. David Allison, Ph.D., a member of our board of directors, is a partner at 5AM Venture Management, LLC. |
Name of Stockholder |
Shares of Series C-3 Redeemable Convertible Preferred Stock |
Total Purchase Price |
||||||
Entities affiliated with Vivo Capital LLC(1) |
8,201,930 | $ | 5,000,000 | |||||
venBio Global Strategic Fund II, L.P.(2) |
8,201,930 | 5,000,000 | ||||||
5AM Ventures V, L.P.(3) |
8,201,930 | 5,000,000 |
(1) | Consists of shares purchased by Vivo VIII and Vivo Surplus, which collectively hold more than 5% of our outstanding capital stock. Vivo Capital VIII, LLC is the general partner of Vivo VIII and Vivo Surplus. Mahendra Shah, Ph.D., a member of our board of directors, is a managing director at Vivo Capital LLC, an affiliate of Vivo Capital VIII, LLC. |
(2) | venBio Strategic Fund holds more than 5% of our outstanding capital stock. Aaron Royston, M.D., was a member of our board of directors until our IPO and is a partner at venBio Partners LLC, an affiliate of venBio Strategic Fund. |
(3) | 5AM Ventures V, L.P. holds more than 5% of our outstanding capital stock. David Allison, Ph.D., a member of our board of directors, is a partner at 5AM Venture Management, LLC. |
Name of Stockholder |
Shares of Series C-2 Redeemable Convertible Preferred Stock |
Total Purchase Price |
||||||
Entities affiliated with Vivo Capital LLC(1) |
8,845,942 | $ | 5,000,000 | |||||
venBio Global Strategic Fund II, L.P.(2) |
8,845,942 | 5,000,000 | ||||||
5AM Ventures V, L.P.(3) |
8,845,942 | 5,000,000 |
(1) | Consists of shares purchased by Vivo VIII and Vivo Surplus, which collectively hold more than 5% of our outstanding capital stock. Vivo Capital VIII, LLC is the general partner of Vivo VIII and Vivo |
Surplus. Mahendra Shah, Ph.D., a member of our board of directors, is a managing director at Vivo Capital LLC, an affiliate of Vivo Capital VIII, LLC. |
(2) | venBio Strategic Fund holds more than 5% of our outstanding capital stock. Aaron Royston, M.D., was a member of our board of directors until our IPO and is a partner at venBio Partners LLC, an affiliate of venBio Strategic Fund. |
(3) | 5AM Ventures V, L.P. holds more than 5% of our outstanding capital stock. David Allison, Ph.D., a member of our board of directors, is a partner at 5AM Venture Management, LLC. |
Name of Stockholder |
Principal Amount of Convertible Notes |
|||
KKR Iris Investors LLC(1) |
$ | 1,591,072 | ||
5AM Ventures V, L.P.(2) |
1,359,799 | |||
venBio Global Strategic Fund II, L.P.(3) |
1,359,799 | |||
Entities affiliated with Vivo Capital LLC(4) |
1,359,799 | |||
Norwest Venture Partners XIV, LP(5) |
1,325,893 |
(1) | KKR Iris holds more than 5% of our outstanding capital stock. Ali Satvat, a member of our board of directors, is a partner at Kohlberg Kravis Roberts & Co. L.P. |
(2) | 5AM Ventures holds more than 5% of our outstanding capital stock. David Allison, Ph.D., a member of our board of directors, is a partner at 5AM Venture Management, LLC. |
(3) | venBio Strategic Fund holds more than 5% of our outstanding capital stock. Aaron Royston, M.D., was a member of our board of directors until our IPO and is a partner at venBio Partners LLC, an affiliate of venBio Strategic Fund. |
(4) | Consists of notes purchased by Vivo VIII and Vivo Surplus, which collectively hold more than 5% of our outstanding capital stock. Vivo Capital VIII, LLC is the general partner of Vivo VIII and Vivo Surplus. Mahendra Shah, Ph.D., a member of our board of directors, is a managing director at Vivo Capital LLC, an affiliate of Vivo Capital VIII, LLC. |
(5) | Norwest Venture Partners holds more than 5% of our outstanding capital stock. NVP Associates, LLC is the managing member of Genesis VC Partners XIV, LLC, which is the general partner of Norwest Venture Partners. Robert Mittendorff, M.D., was a member of our board of directors until our IPO and was a partner at Norwest Venture Partners from 2012 until March 2021. Dr. Mittendorff currently serves as a consultant to Norwest Venture Partners. |
Name of Stockholder |
Shares of Common Stock |
Total purchase price ($) |
||||||
KKR Iris Investors LLC(1) |
1,100,000 | 16,500,000 |
Name of Stockholder |
Shares of Common Stock |
Total purchase price ($) |
||||||
5AM Ventures V, L.P.(2) |
575,000 | 8,625,000 | ||||||
venBio Global Strategic Fund II, L.P.(3) |
450,000 | 6,750,000 | ||||||
Entities affiliated with Vivo Capital LLC(4) |
575,000 | 8,625,000 | ||||||
Norwest Venture Partners XIV, LP(5) |
825,000 | 12,375,000 |
(1) | KKR Iris holds more than 5% of our outstanding capital stock. Ali Satvat, a member of our board of directors, is a partner at Kohlberg Kravis Roberts & Co. L.P. |
(2) | 5AM Ventures holds more than 5% of our outstanding capital stock. David Allison, Ph.D., a member of our board of directors, is a partner at 5AM Venture Management, LLC. |
(3) | venBio Strategic Fund holds more than 5% of our outstanding capital stock. Aaron Royston, M.D., was a member of our board of directors until our IPO and is a partner at venBio Partners LLC, an affiliate of venBio Strategic Fund. |
(4) | Consists of notes purchased by Vivo VIII and Vivo Surplus, which collectively hold more than 5% of our outstanding capital stock. Vivo Capital VIII, LLC is the general partner of Vivo VIII and Vivo Surplus. Mahendra Shah, Ph.D., a member of our board of directors, is a managing director at Vivo Capital LLC, an affiliate of Vivo Capital VIII, LLC. |
(5) | Norwest Venture Partners holds more than 5% of our outstanding capital stock. NVP Associates, LLC is the managing member of Genesis VC Partners XIV, LLC, which is the general partner of Norwest Venture Partners. Robert Mittendorff, M.D., was a member of our board of directors until our IPO and was a partner at Norwest Venture Partners from 2012 until March 2021. Dr. Mittendorff currently serves as a consultant to Norwest Venture Partners. |
∎ |
each of our directors; |
∎ |
each of our named executive officers; |
∎ |
all of our current directors and executive officers as a group; and |
∎ |
each person, or group of affiliated persons, who beneficially owned more than 5% of our outstanding shares of common stock. |
Beneficial Ownership Prior to this Offering |
Beneficial Ownership After this Offering |
|||||||||||||||
Name of Beneficial Owner |
Number |
Percent |
Number |
Percent |
||||||||||||
Named Executive Officers and Directors: |
||||||||||||||||
Adrian Adams(1) |
267,870 | 1.4 | % | 267,870 | 1.2 | % | ||||||||||
Jon Congleton(2) |
322,810 | 1.7 | % | 322,810 | 1.4 | % | ||||||||||
Stephen Shrewsbury, M.B., Ch.B.(3) |
96,874 | * | 96,874 | * | ||||||||||||
John Leaman, M.D.(4) |
128,426 | * | 128,426 | * | ||||||||||||
David Allison, Ph.D. |
– | – | – | – | ||||||||||||
Timothy S. Nelson(5) |
90,443 | * | 90,443 | * | ||||||||||||
H. Stewart Parker(6) |
94,994 | * | 94,994 | * | ||||||||||||
Ali Satvat |
– | – | – | – | ||||||||||||
Mahendra Shah, Ph.D. |
– | – | – | – | ||||||||||||
Diane E. Wilfong(7) |
15,025 | * | 15,025 | * | ||||||||||||
All executive officers and directors as a group (11 persons) |
1,167,210 | 5.7 | % | 1,167,210 | 5.0 | % | ||||||||||
Other 5% Stockholders: |
||||||||||||||||
Entities affiliated with 5AM Ventures V, L.P.(8) |
2,884,791 | 14.8 | % | 2,884,791 | 12.8 | % | ||||||||||
KKR Iris Investors LLC(9) |
3,802,638 | 19.5 | % | 3,802,638 | 16.9 | % | ||||||||||
Norwest Venture Partners XIV, LP(10) |
3,077,198 | 15.8 | % | 3,077,198 | 13.7 | % | ||||||||||
venBio Global Strategic Fund II, L.P.(11) |
2,759,791 | 14.2 | % | 2,759,791 | 12.3 | % | ||||||||||
Entities affiliated with Vivo Capital LLC(12) |
2,884,789 | 14.8 | % | 2,884,789 | 12.8 | % |
* | Represents beneficial ownership of less than one percent. |
(1) | Represents (i) 20,000 shares of common stock, and (ii) 247,870 shares underlying options to purchase common stock that are exercisable within 60 days of June 30, 2021. |
(2) | Represents 322,810 shares of common stock. Mr. Congleton resigned as our President and Chief Executive Officer effective May 4, 2020. |
(3) | Represents 96,874 shares underlying options to purchase common stock that are exercisable within 60 days of June 30, 2021. |
(4) | Represents 128,426 shares underlying options to purchase common stock that are exercisable within 60 days of June 30, 2021. |
(5) | Represents 90,443 shares underlying options to purchase common stock that are exercisable within 60 days of June 30, 2021. |
(6) | Represents (i) 20,151 shares of common stock, and (ii) 74,843 shares underlying options to purchase common stock that are exercisable within 60 days of June 30, 2021. |
(7) | Represents 15,025 shares underlying options to purchase common stock that are exercisable within 60 days of June 30, 2021. |
(8) | Based solely on a Schedule 13G filed with the SEC on May 7, 2021. Represents (i) 2,309,791 shares of common stock held by 5AM Ventures V, L.P., or 5AM Ventures V and (ii) and 575,000 shares of Common Stock held by 5AM Opportunities I, L.P., or Opportunities. David Allison, a member of our board of directors, is a partner at 5AM Venture Management, LLC and has no voting or dispositive power over the shares held by 5AM Ventures V, LLC or Partners V. Andrew Schwab, Kush Parmar and Scott Rocklage are the managing members of Partners V, which is the sole general partner of 5AM Ventures V. 5AM Opportunities I (GP), LLC , or Opportunities GP, serves as the sole general partner of Opportunities. Messrs. Schwab and Parmar are managing members of Opportunities GP. Messrs. Schwab, Parmar and Rocklage may be deemed to share voting and dispositive power over the shares held by 5AM Ventures V and Opportunities. The address of 5AM Venture Management, LLC and its affiliates is 501 2 nd Street, Suite 350, San Francisco, California 94107. |
(9) | Based solely on a Schedule 13D filed with the SEC on May 7, 2021. Represents 3,802,638 shares of common stock held by KKR Iris Investors LLC, or KKR Iris. Each of KKR Health Care Strategic Growth Fund L.P. (as the managing member of KKR Iris); KKR Associates HCSG L.P. (as the general partner of KKR Health Care Strategic Growth Fund L.P.); KKR HCSG GP LLC (as the general partner of KKR Associates HCSG L.P.); KKR Group Partnership L.P. (as the sole member of KKR HCSG GP LLC); KKR Group Holdings Corp. (as the general partner of KKR Group Partnership L.P.); KKR & Co. Inc. (as the sole shareholder of KKR Group Holdings Corp.); KKR Management LLP (as the Series I preferred stockholder of KKR & Co. Inc.); and Messrs. Henry R. Kravis and George R. Roberts (as the founding partners of KKR Management LLP) may be deemed to share voting and dispositive power over the shares held by KKR Iris. The principal business address of each of the entities and persons identified in this footnote, except Mr. Roberts, is c/o Kohlberg Kravis Roberts & Co. L.P., 30 Hudson Yards, New York, New York 10001. The principal business address for Mr. Roberts is c/o Kohlberg Kravis Roberts & Co. L.P., 2800 Sand Hill Road, Suite 200, Menlo Park, CA 94025. |
(10) | Based solely on a Schedule 13G filed with the SEC on August 10, 2021. Represents 3,077,198 shares of common stock held by Norwest Venture Partners XIV, LP, or Norwest XIV. Genesis VC Partners XIV, LLC, or Genesis XIV, is the general partner of Norwest XIV and may be deemed to have sole voting and dispositive power over the shares held by Norwest XIV. NVP Associates, LLC, or NVP Associates, is the managing member of Genesis XIV. Promod Haque, Jeffrey Crowe and Jon E. Kossow, the co-chief executive officers of NVP Associates, may be deemed to share voting and dispositive power over the shares held by Norwest XIV. Each of such individuals, together with NVP Associates and Genesis XIV, disclaims beneficial ownership over the shares held by Norwest XIV except to the extent of their pecuniary interest therein. The address of Norwest is 525 University Avenue, Suite 800, Palo Alto, California 94301. |
(11) | Based solely on a Schedule 13G filed with the SEC on May 7, 2021. Represents 2,759,791 shares of common stock held by venBio Global Strategic Fund II, L.P., or venBio II. venBio |
Global Strategic GP II, Ltd., or venBio Ltd., is the general partner of venBio Global Strategic GP II, L.P., or venBio L.P., which is the general partner of VenBio II. Corey Goodman and Robert Adelman are the directors of venBio Ltd. and may be deemed to share voting and dispositive power over the shares held by venBio II. Each of such individuals, together with venBio Ltd. and venBio L.P., disclaims beneficial ownership over the shares held by venBio II except to the extent of their pecuniary interest therein. The address of venBio is 1700 Owens Street, Suite 595, San Francisco, California 94158. |
(12) | Based solely on a Schedule 13G filed with the SEC on May 6, 2021. Represents (i) 2,535,115 shares of common stock held by Vivo Capital Fund VIII, L.P., or Vivo VIII, and (ii) 349,674 shares of common stock held by Vivo Capital Surplus Fund VIII, L.P., or Vivo Surplus. Mahendra Shah, a member of our board of directors, is a Senior Fellow of Vivo Capital LLC and has no voting or dispositive power over the shares held by each of Vivo VIII or Vivo Surplus. Frank Kung, Edgar Engleman and Shan Fu, Jack Nielsen and Michael Chang are the managing members of Vivo Capital VIII, LLC, or Vivo LLC, which is the general partner of each of Vivo VIII and Vivo Surplus. Messrs. Kung, Engleman, Fu, Nielsen and Chang may be deemed to share voting and dispositive power over the shares held by each of Vivo VIII and Vivo Surplus. Each of such individuals disclaims beneficial ownership over the shares held by each of Vivo VIII and Vivo Surplus except to the extent of their pecuniary interest therein. The address of the each of Vivo VIII and Vivo Surplus is 192 Lytton Avenue, Palo Alto California 94301. |
Type of Capital Stock Underlying Warrant |
Total Number of Shares Subject to Warrants |
Exercise Price Per Share(1) |
||||||
Common Stock |
71,522 | $ | 8.389 |
(1) | The warrants are exercisable in whole or in part, immediately, and have a per share exercise price of $8.389. The warrants will terminate on the earlier of July 2, 2031 or the closing of certain merger or consolidation transactions. |
∎ |
a merger or consolidation with, disposition of assets to, or issuance or redemption of stock to or from the acquiring person; |
∎ |
termination of five percent or more of the employees of the target corporation as a result of the acquiring person’s acquisition of 10% or more of the shares; or |
∎ |
allowing the acquiring person to receive any disproportionate benefit as a stockholder. |
∎ |
prior to the date of the transaction, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder; |
∎ |
the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, but not the outstanding voting stock owned by the interested stockholder, (i) shares owned by persons who are directors and also officers and(ii) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
∎ |
at or subsequent to the date of the transaction, the business combination is approved by the board of directors of the corporation and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66.67% of the outstanding voting stock that is not owned by the interested stockholder. |
∎ |
Board of Directors Vacancies. |
In addition, the number of directors constituting our board of directors is permitted to be set only by a resolution adopted by a majority vote of our entire board of directors. These provisions would prevent a stockholder from increasing the size of our board of directors and then gaining control of our board of directors by filling the resulting vacancies with its own nominees. This makes it more difficult to change the composition of our board of directors but promotes continuity of management. |
∎ |
Classified Board. |
∎ |
Stockholder Action; Special Meetings of Stockholders. |
∎ |
Advance Notice Requirements for Stockholder Proposals and Director Nominations. |
∎ |
No Cumulative Voting. |
∎ |
Directors Removed Only for Cause. two-thirds of our outstanding common stock. |
∎ |
Amendment of Charter Provisions. two-thirds of our outstanding common stock. |
∎ |
Issuance of Undesignated Preferred Stock. |
∎ |
Choice of Forum |
∎ |
insurance companies, banks, investment funds and other financial institutions; |
∎ |
tax-exempt organizations (including private foundations) and tax-qualified retirement plans; |
∎ |
foreign governments and international organizations; |
∎ |
broker-dealers and traders in securities; |
∎ |
U.S. expatriates and certain former citizens or long-term residents of the United States; |
∎ |
“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities, all of the interests of which are held by qualified foreign pension funds; |
∎ |
persons that own, or are deemed to own, more than 5% of our capital stock; |
∎ |
“controlled foreign corporations,” “passive foreign investment companies” and corporations that accumulate earnings to avoid U.S. federal income tax; |
∎ |
persons that hold our common stock as part of a “straddle,” “hedge,” “conversion transaction,” “synthetic security” or integrated investment or other risk reduction strategy; |
∎ |
persons who do not hold our common stock as a capital asset within the meaning of Section 1221 of the Code (generally, for investment purposes); and |
∎ |
partnerships and other entities or arrangements treated as pass-through or disregarded entities for U.S. federal income tax purposes, and investors in such entities (regardless of their places of organization or formation). |
Underwriter |
Number of Shares |
|||
Cowen and Company, LLC |
||||
Guggenheim Securities, LLC |
||||
Wedbush Securities Inc. |
||||
|
|
|||
Total |
3,000,000 | |||
|
|
Total |
||||||||||||
Per Share |
Without Over- Allotment Option |
With Over Allotment Option |
||||||||||
Public offering price |
||||||||||||
Underwriting discounts and commissions |
||||||||||||
Proceeds, before expenses, to us |
∎ |
Stabilizing transactions permit bids to purchase shares of common stock so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding a decline in the market price of the common stock while the offering is in progress. |
∎ |
Overallotment transactions involve sales by the underwriters of shares of common stock in excess of the number of shares the underwriters are obligated to purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the option to purchase additional shares. In a naked short position, the number of shares involved is greater than the number of shares in the option to purchase additional shares. The underwriters may close out any short position by exercising their option to purchase additional shares and/or purchasing shares in the open market. |
∎ |
Syndicate covering transactions involve purchases of common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared with the price at which they may purchase shares through exercise of the option to purchase additional shares. If the underwriters sell more shares than could be covered by exercise of the option to purchase additional shares and, therefore, have a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the shares in the open market that could adversely affect investors who purchase in the offering. |
∎ |
Penalty bids permit the representatives to reclaim a selling concession from a syndicate member when the common stock originally sold by that syndicate member is purchased in stabilizing or syndicate covering transactions to cover syndicate short positions. |
∎ |
to any legal entity which is a qualified investor as defined under Article 2 the Prospectus Regulation; |
∎ |
to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or |
∎ |
in any other circumstances falling within Article 1(4) of the Prospectus Regulation, |
∎ |
to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation; |
∎ |
to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or |
∎ |
in any other circumstances falling within Section 86 of the FSMA, |
∎ |
to an institutional investor (as defined in Section 4A of the Securities and Futures Act (Chapter 289) of Singapore, as modified or amended from time to time (the “SFA”)) pursuant to Section 274 of the SFA; |
∎ |
to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA; or |
∎ |
otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA. |
∎ |
Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is: |
∎ |
a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or |
∎ |
a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor, |
∎ |
to an institutional investor or to a relevant person, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA; |
∎ |
where no consideration is or will be given for the transfer; |
∎ |
where the transfer is by operation of law; |
∎ |
as specified in Section 276(7) of the SFA; or |
∎ |
as specified in Regulation 37A of the Securities and Futures (Offers of Investments) (Securities and Securities-based Derivatives Contracts) Regulations 2018. |
Page |
||||
Audited Consolidated Financial Statements |
||||
F-2 |
||||
F-3 |
||||
F-4 |
||||
F-5 |
||||
F-6 |
||||
F-7 |
||||
Interim Condensed Consolidated Financial Statements (Unaudited) |
||||
F-27 |
||||
F-28 |
||||
F-29 |
||||
F-31 |
||||
F-32 |
December 31, |
||||||||
2019 |
2020 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash |
$ | $ | ||||||
Prepaid expenses and other current assets |
||||||||
Total current assets |
||||||||
Property and equipment, net |
||||||||
Other assets |
– | |||||||
Total assets |
$ | $ | ||||||
Liabilities, redeemable convertible preferred stock and stockholders’ deficit |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued liabilities |
||||||||
Redeemable convertible preferred stock warrant liabilities |
||||||||
Short-term debt |
– | |||||||
Total current liabilities |
||||||||
Long-term debt |
– | |||||||
Total liabilities |
||||||||
Commitments and contingencies (Note 5) |
||||||||
Redeemable convertible preferred stock, $ |
||||||||
Stockholders’ deficit: |
||||||||
Common stock, $ |
– | |||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Total stockholders’ deficit |
( |
) | ( |
) | ||||
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit |
$ | $ | ||||||
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Operating expenses: |
||||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
Total operating expenses |
||||||||
Loss from operations |
( |
) | ( |
) | ||||
Interest income (expense), net |
( |
) | ||||||
Other expense, net |
( |
) | ( |
) | ||||
Loss before income taxes |
( |
) | ( |
) | ||||
Provision for income taxes |
( |
) | ( |
) | ||||
Net loss and comprehensive loss |
( |
) | ( |
) | ||||
Accretion on redeemable convertible preferred stock |
( |
) | ( |
) | ||||
Net loss attributable to common stockholders |
$ | ( |
) | $ | ( |
) | ||
Net loss per share attributable to common stockholders, basic and diluted |
$ | ( |
) | $ | ( |
) | ||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
||||||||
Redeemable Convertible Preferred Stock |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Total Stockholders’ Deficit |
||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||
Balance—December 31, 2018 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Accretion to redemption value on redeemable convertible preferred stock |
– | – | – | ( |
) |
– | ( |
) | ||||||||||||||||||||||||||||
Stock-based compensation expense |
– | – | – | – | – | |||||||||||||||||||||||||||||||
Issuance of common stock upon the exercise of stock options |
– | – | – | – | ||||||||||||||||||||||||||||||||
Net loss and comprehensive loss |
– | – | – | – | – | ( |
) |
( |
) | |||||||||||||||||||||||||||
Balance—December 31, 2019 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Accretion to redemption value on redeemable convertible preferred stock |
– | – | – | ( |
) |
– | ( |
) | ||||||||||||||||||||||||||||
Stock-based compensation expense |
– | – | – | – | – | |||||||||||||||||||||||||||||||
Issuance of common stock upon the exercise of stock options |
– | – | – |
– | ||||||||||||||||||||||||||||||||
Issuance of Series A-2 redeemable convertible preferred stock upon exercise of Series A-2 warrants |
– | – | – | – | – | |||||||||||||||||||||||||||||||
Issuance of Series B redeemable convertible preferred stock upon exercise of Series B warrants |
– | – | – | – | – | |||||||||||||||||||||||||||||||
Net loss and comprehensive loss |
– | – | – | – | – | ( |
) |
( |
) | |||||||||||||||||||||||||||
Balance—December 31, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
||||||||
Stock-based compensation |
||||||||
Change in fair value of redeemable convertible preferr e d stock warrant liabilities |
||||||||
Amortization of debt discount |
– | |||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ||||||
Other assets |
( |
) | ||||||
Accounts payable |
||||||||
Accrued liabilities |
( |
) | ||||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Purchases of property and equipment |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Proceeds from issuance of common stock upon exercise of stock options |
||||||||
Proceeds from issuance of debt |
– | |||||||
Proceeds from issuance of redeemable convertible preferred stock upon the exercise of redeemable convertible preferred stock warrants |
– | |||||||
Proceeds from Paycheck Protection Program loan |
– | |||||||
Repayment of Paycheck Protection Program loan |
– | ( |
) | |||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
|
|
|
|
|||||
Net decrease in cash |
( |
) | ( |
) | ||||
Cash—Beginning of period |
||||||||
|
|
|
|
|||||
Cash—End of period |
$ | $ | ||||||
|
|
|
|
|||||
Supplemental disclosures of cash flow information: |
||||||||
Recognition of fair value of warrants issued in connection with issuance of debt |
$ | – | $ | |||||
|
|
|
|
|||||
Property and equipment included in accounts payable and accrued liabilities |
$ | $ | ||||||
|
|
|
|
|||||
Reclassification of redeemable convertible preferred stock warrant liability to redeemable convertible preferred stock upon exercise of warrants |
$ | — | $ | |||||
|
|
|
|
1. |
Organization and Description of Business |
Liquidity |
and Capital Resources |
2. |
Summary of Significant Accounting Policies |
Basis |
of Presentation and Consolidation |
Segments |
Cash |
Concentration |
of Credit Risk |
Other |
Assets |
Property |
and Equipment, Net |
Impairment |
of Long-Lived Assets |
Fair |
Value Measurement |
Redeemable |
Convertible Preferred Stock Warrant Liabilities |
Leases |
Research |
and Development |
Advance |
Payments for Research and Development Services and Accruals |
General |
and Administrative Costs |
Stock-Based |
Compensation |
Income |
Taxes |
Net |
Loss Per Share Attributable to Common Stockholders |
Comprehensive |
Loss |
Recent |
Accounting Pronouncements |
Recently |
Adopted Pronouncements |
3. |
Fair Value Measurements |
December 31, 2019 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock warrant liabilities |
$ | $ | $ | $ | ||||||||||||
Total financial liabilities |
$ | $ | $ | $ | ||||||||||||
December 31, 2020 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock warrant liabilities |
$ | $ | $ | $ | ||||||||||||
Total financial liabilities |
$ | $ | $ | $ | ||||||||||||
December 31, |
||||||||
2019 |
2020 |
|||||||
Beginning balance |
$ | $ | ||||||
Losses from changes in fair value |
||||||||
Exercise of warrants |
( |
) | ||||||
Issuance of warrants |
||||||||
Ending balance |
$ | $ | ||||||
4. |
Balance Sheet Components |
Prepaid |
Expenses and Other Current Assets |
December 31, |
||||||||
2019 |
2020 |
|||||||
Refundable clinical deposits |
$ | $ | ||||||
Tax refund receivable |
||||||||
Refundable security deposit |
||||||||
Prepaid insurance |
||||||||
Other prepaids and current assets |
||||||||
Total prepaid expenses and other current assets |
$ | $ | ||||||
Property |
and Equipment, Net |
December 31, |
||||||||
2019 |
2020 |
|||||||
Laboratory and platform equipment |
$ | $ | ||||||
Furniture and office equipment |
||||||||
Leasehold improvements |
||||||||
Construction in progress |
||||||||
Total property and equipment, gross |
||||||||
Less: accumulated depreciation and amortization |
( |
) | ( |
) | ||||
Total property and equipment, net |
$ | $ | ||||||
Accrued |
Liabilities |
December 31, |
||||||||
2019 |
2020 |
|||||||
Accrued professional services |
$ | $ | ||||||
Accrued compensation |
||||||||
Accrued other liabilities |
||||||||
Accrued construction in progress |
||||||||
Total accrued liabilities |
$ | $ | ||||||
5. |
Commitments and Contingencies |
Legal |
Proceedings |
Indemnifications |
COVID-19 |
6. |
Debt |
Payroll |
Protection Program |
Term |
Loan |
December 31, 2020 |
||||
Face value of term loan |
$ | |||
Final payment |
||||
Unamortized debt discount associated with final payment, issuance date warrant fair value, and financing costs |
( |
) | ||
Total debt, net |
||||
Less: short-term debt |
||||
Long-term debt |
$ | |||
7. |
Redeemable Convertible Preferred Stock Warrant Liabilities |
Number of shares as of December 31, |
Exercise Price |
Expiration |
||||||||||||||
Exercisable into: |
2019 |
2020 |
||||||||||||||
Series A-2 redeemable convertible preferred stock |
$ | |||||||||||||||
Series B redeemable convertible preferred stock |
||||||||||||||||
Series C-1 redeemable convertible preferred stock |
||||||||||||||||
Series D redeemable convertible preferred stock |
||||||||||||||||
Total |
||||||||||||||||
8. |
Redeemable Convertible Preferred Stock |
Redeemable Convertible Preferred Stock |
Shares Authorized |
Shares Issued and Outstanding |
Carrying Value at December 31, 2019 |
Aggregate Liquidation Preference |
||||||||||||
Series A-1 |
$ | $ | ||||||||||||||
Series A-2 |
||||||||||||||||
Series B |
||||||||||||||||
Series C-1 |
||||||||||||||||
Series C-2 |
||||||||||||||||
Series C-3 |
||||||||||||||||
Series D |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | ||||||||||||||
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Stock |
Shares Authorized |
Shares Issued and Outstanding |
Carrying Value at December 31, 2020 |
Aggregate Liquidation Preference |
||||||||||||
Series A-1 |
$ | $ | ||||||||||||||
Series A-2 |
||||||||||||||||
Series B |
||||||||||||||||
Series C-1 |
||||||||||||||||
Series C-2 |
||||||||||||||||
Series C-3 |
||||||||||||||||
Series D |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | ||||||||||||||
|
|
|
|
|
|
|
|
Conversion |
Rights |
Dividends |
Liquidation |
Redemption |
Voting |
Rights |
Classification |
9. |
Common Stock |
December 31, |
||||||||
2019 |
2020 |
|||||||
Stock incentive plans |
||||||||
Redeemable convertible preferred stock |
||||||||
Redeemable convertible preferred stock warrants |
||||||||
Total |
||||||||
10. |
Stock Incentive Plan |
2008 |
Plan |
2018 |
Plan |
Stock |
Option Activity |
Options Outstanding |
||||||||||||||||||||
Shares Available for Grant |
Number of Options |
Weighted- Average Exercise Price |
Remaining Contractual Term (Years) |
Aggregate Intrinsic Value |
||||||||||||||||
Balance—December 31, 2019 |
$ | $ | ||||||||||||||||||
Authorized |
– | – | ||||||||||||||||||
Granted |
( |
) | $ | |||||||||||||||||
Exercised |
( |
) | $ | |||||||||||||||||
Cancelled |
( |
) | $ | |||||||||||||||||
Balance—December 31, 2020 |
$ | $ | ||||||||||||||||||
Exercisable—December 31, 2020 |
$ | $ | ||||||||||||||||||
Stock-Based |
Compensation Expense |
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
Total stock-based compensation expense |
$ | $ | ||||||
Year Ended December 31, | ||||
2019 |
2020 | |||
Expected term (in years) |
||||
Expected volatility |
||||
Risk-free interest rate |
||||
Expected dividends |
– % |
– % |
11. |
Income Taxes |
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Domestic |
$ | ( |
) | $ | ( |
) | ||
Foreign |
||||||||
Total loss before provision for income tax |
$ | ( |
) | $ | ( |
) | ||
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Current: |
||||||||
Federal |
$ | – | $ | |||||
State |
||||||||
Foreign |
– | |||||||
Total current tax expense |
$ | $ | ||||||
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Tax provision at U.S. statutory rate |
$ | ( |
) | $ | ( |
) | ||
Permanent differences |
||||||||
Change in valuation allowance |
||||||||
Research and development credits |
( |
) | ( |
) | ||||
Other |
( |
) | ||||||
Provision for income taxes |
$ | $ | ||||||
December 31, |
||||||||
2019 |
2020 |
|||||||
Deferred tax assets: |
||||||||
Net operating losses |
$ | $ | ||||||
Research and development and other tax credits |
||||||||
Other |
||||||||
Gross deferred tax assets |
||||||||
Less valuation allowance |
( |
) | ( |
) | ||||
Total deferred tax assets |
– | |||||||
Deferred tax liabilities: |
||||||||
Fixed assets |
( |
) | – | |||||
Gross deferred tax liabilities |
( |
) | – | |||||
Net deferred tax asset |
$ | – | $ | |||||
Balance as of December 31, 2018 |
$ | |||
Increases related to prior year tax positions |
||||
Increases related to current year tax positions |
||||
|
|
|||
Balance as of December 31, 2019 |
||||
Increases related to prior year tax positions |
||||
Increases related to current year tax positions |
||||
|
|
|||
Balance as of December 31, 2020 |
$ | |||
|
|
12. |
Defined Contribution Plan |
13. |
Net Loss Per Share Attributable to Common Stockholders |
Year Ended December 31, |
||||||||
2019 |
2020 |
|||||||
Redeemable convertible preferred stock on an as-converted basis |
||||||||
Redeemable convertible preferred stock warrants on an as-converted basis |
||||||||
Stock options to purchase common stock |
||||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
14. |
Subsequent Events |
a) | In March 2021, the Company issued convertible promissory notes to various investors for an aggregate amount of $ 90 % of the price per share. |
b) | In the first quarter of 2021, the Company granted |
c) | In April 2021, the Company’s board of directors and stockholders approved an amendment to the Company’s certificate of incorporation to effect a reverse split of shares of the Company’s common stock on an |
June 30, 2021 |
December 31, 2020 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Prepaid expenses and other current assets |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Property and equipment, net |
||||||||
Other assets |
||||||||
|
|
|
|
|||||
Total assets |
$ | $ | ||||||
|
|
|
|
|||||
Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued liabilities |
||||||||
Current portion of term debt |
— | |||||||
Redeemable convertible preferred stock warrant liabilities |
— | |||||||
|
|
|
|
|||||
Total current liabilities |
$ | $ | ||||||
|
|
|
|
|||||
Convertible notes at fair value |
— | |||||||
Long-term debt |
||||||||
|
|
|
|
|||||
Total liabilities |
$ | $ | ||||||
|
|
|
|
|||||
Commitments and contingencies (Note 5) |
||||||||
Redeemable convertible preferred stock, $ |
$ | $ | ||||||
Stockholders’ equity (deficit): |
||||||||
Preferred stock, $ |
||||||||
Common stock, $ e ctively |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total stockholders’ equity (deficit) |
$ | $ | ( |
) | ||||
|
|
|
|
|||||
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
$ | $ | ||||||
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
Total operating expenses |
||||||||||||||||
Loss from operations |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Other (expense) income, net |
( |
) | ( |
) | ||||||||||||
Loss before income taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Provision (benefit) for income taxes |
( |
) | ||||||||||||||
Net loss and comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Accretion on redeemable convertible preferred stock |
||||||||||||||||
Net loss attributable to common stockholders |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Net loss per share attributable to common stockholders, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
||||||||||||||||
Redeemable Convertible Preferred Stock |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Total Stockholders’ Equity (Deficit) |
||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||
Balance — December 31, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Accretion to redemption value on redeemable convertible preferred stock |
— | — | — | ( |
) |
— | ( |
) | ||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Issuance of common stock upon the exercise of stock options |
— | — | — | — | ||||||||||||||||||||||||||||||||
Net loss and comprehensive loss |
— | — | — | — | — | ( |
) |
( |
) | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance — March 31, 2021 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Proceeds from initial public offering, net of underwriters’ discounts and commissions of $ |
— | — | — | |||||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of warrants for cash |
— | — | — | |||||||||||||||||||||||||||||||||
Issuance of common stock upon net exercise of warrants upon initial public offering |
— | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock upon exchange of Avenue warrant |
— | |||||||||||||||||||||||||||||||||||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||
Conversion of convertible notes into common st o ck at initial public offering |
— | — | — | |||||||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Issuance of common stock upon the exercise of stock options |
— | — | — | — | ||||||||||||||||||||||||||||||||
Net loss and comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance — June 30, 2021 |
$ | $ | $ | $ | ( |
) | $ | |||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Stock |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Total Stockholders’ Equity (Deficit) |
||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
|||||||||||||||||||||||||||||||||
Balance — December 31, 2019 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Accretion to redemption value on redeemable convertible preferred stock |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Issuance of common stock upon the exercise of stock options |
— | — | — | — | ||||||||||||||||||||||||||||||||
Net loss and comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||
Balance — March 31, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Accretion to redemption value on redeemable convertible preferred stock |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||||
Stock-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Issuance of Series A-2 redeemable convertible preferred stock upon the exercise of preferred warrants |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Net loss and comprehensive loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||
Balance — June 30, 2020 |
$ | $ | $ | $ | ( |
) | $ | ( |
) | |||||||||||||||||||||||||||
Six Months Ended June 30, |
||||||||
2021 |
2020 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
||||||||
Stock-based compensation |
||||||||
Change in fair value of redeemable convertible preferred stock warrant liabilities |
( |
) | ||||||
Change in fair value of convertible notes |
– | |||||||
Noncash interest |
– | |||||||
Amortization of debt discount |
– | |||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
( |
) | ( |
) | ||||
Other assets |
( |
) | ||||||
Accounts payable |
||||||||
Accrued liabilities |
( |
) | ||||||
Net cash used in operating activities |
$ | ( |
) | $ | ( |
) | ||
Cash flows from investing activities: |
||||||||
Purchases of property and equipment |
( |
) | ( |
) | ||||
Net cash used in investing activities |
$ | ( |
) | $ | ( |
) | ||
Cash flows from financing activities: |
||||||||
Proceeds from initial public offering, net of issuance costs |
– | |||||||
Proceeds from the issuance of convertible notes |
– | |||||||
Proceeds from exercise of redeemable convertible preferred stock warrants |
||||||||
Proceeds from issuance of common stock upon exercise of stock options |
||||||||
Net cash provided by financing activities |
$ | $ | ||||||
Net increase (decrease) in cash |
( |
) | ||||||
Cash — Beginning of period |
||||||||
Cash — End of period |
$ | $ | ||||||
Supplemental disclosures of cash flow information: |
||||||||
Accretion to redemption value on redeemable convertible preferred stock |
$ | $ | ||||||
Conversion of redeemable convertible preferred stock upon initial public offering |
– | |||||||
Issuance of common stock upon exchange / exercise of redeemable convertible preferred stock warrants upon initial public offering |
– | |||||||
Conversion of convertible notes into common stock upon initial public offering |
– | |||||||
Purchase of property and equipment included in accounts payable and accrued liabilities |
$ | $ |
1. |
Organization and Description of Business |
Initial |
Public Offering |
Reverse |
Stock Split |
Liquidity |
and Capital Resources |
2. |
Summary of Significant Accounting Policies |
Basis |
of Presentation and Consolidation |
Reclassifications |
Use |
of Estimates |
Segments |
Cash |
Concentration |
of Credit Risk |
Fair |
Value Measurement |
Convertible |
Notes |
Deferred |
Offering Costs |
Redeemable |
Convertible Preferred Stock Warrant Liabilities |
Research |
and Development |
Advance |
Payments for Research and Development Services and Accruals |
Stock-Based |
Compensation |
Net |
Loss Per Share Attributable to Common Stockholders |
Comprehensive |
Loss |
Recent |
Accounting Pronouncements |
Recently |
Adopted Pronouncements |
3. |
Fair Value Measurements |
December 31, 2020 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
Liabilities: |
||||||||||||||||
Redeemable convertible preferred stock warrant liabilities |
$ | $ | $ | $ | ||||||||||||
Total financial liabilities |
$ | $ | $ | $ | ||||||||||||
Beginning balance as of December 31, 2020 |
||||
Losses from changes in fair value |
||||
Settlement upon IPO |
( |
) | ||
Ending balance as of June 30, 2021 |
$ | |||
Beginning balance as of December 31, 2020 |
$ | |||
Issuance of convertible notes |
||||
Interest |
||||
Losses from changes in fair value |
||||
Conversion upon IPO |
( |
) | ||
Ending balance as of June 30, 2021 |
$ | |||
4. |
Balance Sheet Components |
Prepaid |
Expenses and Other Current Assets |
June 30, 2021 |
December 31, 2020 |
|||||||
Refundable clinical deposits |
$ | $ | ||||||
Tax refund receivable |
||||||||
Prepaid insurance |
||||||||
Other prepaids and current assets |
||||||||
Total prepaid expenses and other current assets |
$ | $ | ||||||
Accrued |
Liabilities |
June 30, 2021 |
December 31, 2020 |
|||||||
Accrued professional services |
$ | $ | ||||||
Accrued compensation |
||||||||
Accrued other liabilities |
||||||||
Accrued construction in progress |
||||||||
Total accrued liabilities |
$ | $ | ||||||
5. |
Commitments and Contingencies |
Operating |
Leases |
Legal |
Proceedings |
Indemnifications |
COVID-19 |
6. |
Debt |
Term |
Loan |
June 30, 2021 |
December 31, 2020 |
|||||||
Face value of term loan |
$ | $ | ||||||
Final payment |
||||||||
Unamortized debt discount associated with final payment, issuance date warrant fair value, and financing costs |
( |
) | ( |
) | ||||
Total debt, net |
$ | $ | ||||||
Less: short-term debt |
||||||||
Long-term debt |
$ | $ | ||||||
Convertible |
Promissory Notes |
7. |
Redeemable Convertible Preferred Stock Warrant Liabilities |
Number of shares as of |
Exercise Price |
Expiration |
||||||||||||||
Exercisable into: |
June 30, 2021 |
December 31, 2020 |
||||||||||||||
Series A-2 redeemable convertible preferred stock |
$ | |||||||||||||||
Series C-1 redeemable convertible preferred stock |
||||||||||||||||
Series D redeemable convertible preferred stock |
||||||||||||||||
Total |
||||||||||||||||
8. |
Redeemable Convertible Preferred Stock |
Redeemable Convertible Preferred Stock |
Shares Authorized |
Shares Issued and Outstanding |
Carrying Value at December 31, 2020 |
Aggregate Liquidation Preference |
||||||||||||
Series A-1 |
$ | $ | ||||||||||||||
Series A-2 |
||||||||||||||||
Series B |
||||||||||||||||
Series C-1 |
||||||||||||||||
Series C-2 |
||||||||||||||||
Series C-3 |
||||||||||||||||
Series D |
||||||||||||||||
Total |
$ | $ | ||||||||||||||
Classification |
9. |
Common Stock |
June 30, 2021 |
December 31, 2020 |
|||||||
Stock incentive plans |
||||||||
Redeemable convertible preferred stock |
||||||||
Convertible notes |
||||||||
Redeemable convertible preferred stock warrants |
||||||||
Total |
||||||||
10. |
Stock Incentive Plan |
2021 |
Equity Incentive Plan |
2008 |
Plan |
2018 |
Plan |
Stock |
Option Activity |
Options Outstanding |
||||||||||||||||||||
Shares Available for Grant |
Number of Options |
Weighted -Average Exercise Price |
Remaining Contractual Term (Years) |
Aggregate Intrinsic Value |
||||||||||||||||
Balance—December 31, 2020 |
$ | $ | ||||||||||||||||||
Authorized |
– | |||||||||||||||||||
Granted |
( |
) | ||||||||||||||||||
Exercised |
– | ( |
) | |||||||||||||||||
Cancelled |
( |
) | ||||||||||||||||||
Balance—June 30, 2021 |
$ | $ | ||||||||||||||||||
Exercisable—June 30, 2021 |
– | $ | $ | |||||||||||||||||
Stock-Based |
Compensation Expense |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
General and administrative |
$ | $ | $ | $ | ||||||||||||
Research and development |
||||||||||||||||
Total stock-based compensation expense |
$ | $ | $ | $ | ||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, | |||||||
2021 |
2020 |
2021 |
2020 | |||||
Expected term (in years) |
||||||||
Expected volatility |
||||||||
Risk-free interest rate |
||||||||
Expected dividends |
11. |
Income Taxes |
12. |
Defined Contribution Plan |
13. |
Net Loss Per Share Attributable to Common Stockholders |
Six Months Ended June 30, |
||||||||
2021 |
2020 |
|||||||
Redeemable convertible preferred stock on an as-converted basis |
||||||||
Redeemable convertible preferred stock warrants on an as-converted basis |
||||||||
Convertible notes on an as-converted basis |
||||||||
Stock options to purchase common stock |
||||||||
Total |
||||||||
14. |
Subsequent Events |
Cowen |
Guggenheim Securities |
Amount Paid or To Be Paid |
||||
SEC registration fee |
$ | 7,020 | ||
FINRA filing fee |
10,152 | |||
Printing and engraving expenses |
150,000 | |||
Legal fees and expenses |
400,000 | |||
Accounting fees and expenses |
175,000 | |||
Transfer agent and registrar fees and expenses |
5,000 | |||
Miscellaneous expenses |
12,828 | |||
|
|
|||
Total |
$ | 760,000 | ||
|
|
∎ |
any breach of the director’s duty of loyalty to the registrant or its stockholders; |
∎ |
acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; |
∎ |
under Section 174 of the DGCL (regarding unlawful dividends and stock purchases); or |
∎ |
any transaction from which the director derived an improper personal benefit. |
∎ |
the registrant is required to indemnify its directors and executive officers to the fullest extent permitted by the DGCL, subject to limited exceptions; |
∎ |
the registrant may indemnify its other employees and agents as set forth in the DGCL; |
∎ |
the registrant is required to advance expenses, as incurred, to its directors and executive officers in connection with a legal proceeding to the fullest extent permitted by the DGCL, subject to limited exceptions; and |
∎ |
the rights conferred in the restated bylaws are not exclusive. |
Exhibit Number |
Description |
Form |
File No. |
Exhibit |
Filing Date |
Filed/Furnished Herewith | ||||||
1.1 | Form of Underwriting Agreement. | X | ||||||||||
3.1 | Restated Certificate of Incorporation. | 10-Q |
001-40353 |
3.1 | June 7, 2021 | |||||||
3.2 | Restated Bylaws. | 10-Q |
001-40353 |
3.2 | June 7, 2021 | |||||||
4.1 | Form of Registrant’s Common Stock Certificate. | S-1/A |
333-254999 |
4.1 | April 19, 2021 | |||||||
4.2 | Amended and Restated Investors’ Rights Agreement, dated December 4, 2018, by and among the registrant and certain of its stockholders. | S-1 |
333-254999 |
4.2 | April 2, 2021 | |||||||
4.3 | Form of 2021 Convertible Promissory Note. | S-1 |
333-254999 |
4.3 | April 2, 2021 |
^ | Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request. |
IMPEL NEUROPHARMA, INC. | ||
By: |
/s/ Adrian Adams | |
Adrian Adams Chief Executive Officer |
Signature |
Title |
Date | ||
/s/ Adrian Adams Adrian Adams |
Chief Executive Officer and Director (Principal Executive Officer) |
September 7, 2021 | ||
/s/ John Leaman, M.D. John Leaman, M.D. |
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
September 7, 2021 | ||
/s/ David Allison, Ph.D. David Allison, Ph.D. |
Director | September 7, 2021 | ||
/s/ Timothy S. Nelson Timothy S. Nelson |
Director | September 7, 2021 | ||
/s/ H. Stewart Parker H. Stewart Parker |
Director | September 7, 2021 |
Signature |
Title |
Date | ||
/s/ Ali Satvat Ali Satvat |
Director | September 7, 2021 | ||
/s/ Mahendra G. Shah, Ph.D. Mahendra G. Shah, Ph.D. |
Director | September 7, 2021 | ||
/s/ Diane Wilfong Diane Wilfong |
Director | September 7, 2021 |