Delaware (State or other jurisdiction of incorporation or organization) | | | 2834 (Primary Standard Industrial Classification Code Number) | | | 82-4566526 (I.R.S. Employer Identification Number) |
Tony Jeffries Miranda Biven Jennifer Knapp Wilson Sonsini Goodrich & Rosati Professional Corporation 650 Page Mill Road Palo Alto, CA 94304 (650) 493-9300 | | | Mark Meltz Chief Operating Officer and General Counsel Kinnate Biopharma Inc. 11975 El Camino Real, Suite 101 San Diego, CA 92130 (858) 299-4699 | | | Charles Kim Jonie Kondracki Dave Peinsipp Cooley LLP 4401 Eastgate Mall San Diego, CA 92121 (858) 550-6000 |
| | | | Accelerated filer | | | ☐ | ||
Large accelerated filer | | | ☐ | | | Smaller reporting company | | | ☒ |
Non-accelerated filer | | | ☒ | | | Emerging growth company | | | ☒ |
Title of Each Class of Securities to be Registered | | | Amount to be Registered | | | Proposed Maximum Offering Price Per Share(2) | | | Proposed Maximum Aggregate Offering Price(1)(2) | | | Amount of Registration Fee(3) |
Common Stock $0.0001 par value | | | 13,225,000 | | | $19.00 | | | $251,275,000 | | | $27,415 |
(1) | Includes offering price of the 1,725,000 additional shares of common stock that the underwriters have the option to purchase. |
(2) | Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(a) under the Securities Act of 1933, as amended. |
(3) | The Registration previously paid $22,584 in connection with the previous filings of the Registration Statement. |
| | Per Share | | | Total | |
| | | | |||
Initial public offering price | | | $ | | | $ |
Underwriting discounts and commissions(1) | | | $ | | | $ |
Proceeds, before expenses, to Kinnate Biopharma Inc. | | | $ | | | $ |
(1) | See the section titled “Underwriting” for a description of the compensation payable to the underwriters. |
Goldman Sachs & Co. LLC | | | SVB Leerink | | | Piper Sandler |
Wedbush PacGrow |
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• | Structure-based drug discovery. Through our integrated biology and chemistry approach led by experts in small molecule kinase inhibitors, we identify compounds with a high probability of success in inhibiting selective kinase targets. |
• | Translational research. We employ a biomarker-driven approach to predict and increase the likelihood of therapeutic response to our product candidates in patients. |
• | Patient-driven precision medicine. Capitalizing on next-generation sequencing technologies and guidance from leaders at experienced precision medicine cancer centers, we define emerging patient populations for our product candidates. |
• | those with cancers that harbor known oncogenic drivers with no currently available targeted therapies; |
• | those with genomically well-characterized tumors that have intrinsic resistance to currently available treatments (non-responders); and |
• | those whose tumors have acquired resistance over the course of therapy to currently available treatments. |
• | define emerging patient populations; |
• | demonstrate selective in vitro and in vivo activity and define dose-exposure pharmacodynamic relationships in clinically relevant models; |
• | test prioritized compounds against specific mutations and fusions; |
• | investigate mechanism of action—the specific biochemical interaction through which a drug substance produces its pharmacological effect—to support the refinement of strategies for patient selection and patient stratification for both monotherapy and rationale combinations; and |
• | develop biomarker-based development strategies that will drive patient selection in our clinical programs. |
• | Rapidly advance the development of our lead targeted therapy RAF and FGFR candidates. |
• | Develop a pipeline of product candidates focused on overcoming the limitations of current targeted oncology therapeutics. |
• | Increase our probability of clinical success by prioritizing known oncogenic drivers for development and incorporating biomarkers into preclinical and clinical development. |
• | Leverage our existing relationships, collaborations and experience to efficiently develop and expand our product portfolio. |
• | Maximize the clinical impact and value of our portfolio. |
• | Precision oncology and kinase inhibitor experts who have held leadership positions at four of the top global oncology companies: Amgen Inc., AstraZeneca plc, Novartis AG, and Pfizer Inc. Our team includes one of the inventors of Inlyta (axitinib), Lorbrena (lorlatinib) and Xalkori (crizotinib), the research co-lead for LXH254 and the translational co-lead for PLX8394. Our team members have also been involved with the development of Mektovi (binimetinib), Cabometyx (cabozantinib), Tabrecta (capmatinib), Zykadia (ceritinib), Braftovi (encorafenib), Rozlytrek (entrectinib) and EGF816. |
• | Functional experts across domains such as biomarkers and toxicology who have developed their expertise at companies including AstraZeneca plc, Exelixis, Inc., GRAIL, Inc., Puma Biotechnology, Inc. and WuXi NextCODE Genomics USA, Inc. (now known as Genuity Science, Inc.). |
• | Senior leaders with a track record of success who have built and operated drug development businesses from research and development to commercial-stage operations at companies including Audentes Therapeutics, Inc., Biogen Inc., Novartis AG, PaxVax, Inc. (now part of Emergent BioSolutions Inc.), and Quanticel Pharmaceuticals, Inc. |
• | We are very early in our development efforts, have a limited operating history, have not initiated or completed any clinical trials, have no products approved for commercial sale and have not generated any revenue, which may make it difficult for investors to evaluate our current business and likelihood of success and viability. |
• | We have incurred significant net losses in each period since our inception, and we expect to continue to incur significant net losses for the foreseeable future. |
• | Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve our objectives relating to the discovery, development and commercialization of our product candidates. |
• | Even if this offering is successful, we will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate one or more of our research and drug development programs, future commercialization efforts, product development or other operations. |
• | We are very early in our development efforts and are substantially dependent on our RAF and FGFR programs. If we are unable to advance any product candidates from our RAF or FGFR programs through preclinical and clinical development, obtain regulatory approval and ultimately commercialize such product candidates, or experience significant delays in doing so, our business will be materially harmed. |
• | Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization. |
• | Our discovery and preclinical development activities are focused on the development of targeted therapeutics for patients with genomically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs is novel and may never lead to approved or marketable products. |
• | The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, European Medicines Agency (EMA) or other comparable foreign regulatory authorities. |
• | In addition to our RAF and FGFR programs, our prospects depend in part upon discovering, developing and commercializing product candidates from our CDK12 and other research programs, which may fail in development or suffer delays that adversely affect their commercial viability. |
• | Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and expand our Kinnate Discovery Engine to build a pipeline of product candidates with commercial value. |
• | The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval of our product candidates, we will be unable to generate product revenue and our business will be substantially harmed. |
• | We have no experience as a company in conducting clinical trials. |
• | The COVID-19 pandemic could adversely impact our business, including our planned clinical trials and ongoing and planned preclinical studies. |
• | We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do. |
• | Our success depends on our ability to protect our intellectual property and our proprietary technologies. |
• | 5,700,154 shares of common stock issuable upon the exercise of options outstanding as of September 30, 2020 with a weighted-average exercise price of $3.08 per share; |
• | 546,759 shares of common stock issuable upon the exercise of options granted after September 30, 2020 with a weighted-average exercise price of $8.39 per share; |
• | 1,117,217 shares of common stock reserved for future issuance under our 2018 Equity Incentive Plan, as amended, as of September 30, 2020, which shares will be added to the shares to be reserved for future issuance under our 2020 Equity Incentive Plan (2020 Plan); |
• | 5,218,000 shares of common stock reserved for future issuance under our 2020 Plan (which does not give effect to the grant of 121,503 shares of common stock issuable upon the exercise of stock options which will be granted, as of the effective date of the registration statement of which this prospectus forms a part, under our 2020 Plan, at an exercise price equal to the initial public offering price of our common stock), which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, as well as any automatic increases in the number of shares of common stock reserved for future issuance under this plan; and |
• | 435,000 shares of common stock reserved for future issuance under our 2020 Employee Stock Purchase Plan (2020 ESPP), which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, as well as any automatic increases in the number of shares of common stock reserved for future issuance under this plan. |
• | a 1-for-1.23453 reverse stock split of our capital stock, which was effected on November 25, 2020; |
• | no exercise of the outstanding options referred to above; |
• | no exercise by the underwriters of their option to purchase 1,725,000 additional shares of common stock from us in this offering; |
• | the automatic conversion of all outstanding shares of our convertible preferred stock as of September 30, 2020 into an aggregate of 25,778,437 shares of our common stock immediately prior to the completion of this offering; and |
• | the filing and effectiveness of our amended and restated certificate of incorporation and the adoption of our amended and restated bylaws, each of which will occur immediately prior to the completion of this offering. |
| | Period from January 4, 2018 (inception) through December 31, 2018 | | | Year Ended December 31, 2019 | | | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |||||||
| | | | | | (unaudited) | ||||||
| | (in thousands, except share and per share amounts) | ||||||||||
Statements of Operations Data: | | | | | | | | | ||||
Operating expenses: | | | | | | | | | ||||
Research and development (includes related party amounts of $1,454, $2,301, $1,551, and $0, respectively) | | | $5,675 | | | $8,955 | | | $5,896 | | | $17,261 |
General and administrative (includes related party amounts of $1,600, $2,609, $1,827, and $92, respectively) | | | 1,955 | | | 3,057 | | | 2,131 | | | 5,021 |
Total operating expenses | | | 7,630 | | | 12,012 | | | 8,027 | | | 22,282 |
Loss from operations | | | (7,630) | | | (12,012) | | | (8,027) | | | (22,282) |
Other income: | | | | | | | | | ||||
Interest income | | | — | | | 43 | | | — | | | 228 |
Total other income | | | — | | | 43 | | | — | | | 228 |
Net loss and comprehensive loss | | | $(7,630) | | | $(11,969) | | | $(8,027) | | | $(22,054) |
Gain on extinguishment of Series A convertible preferred stock | | | — | | | 2,031 | | | 2,031 | | | — |
Net loss attributable to common stockholders | | | $(7,630) | | | $(9,938) | | | $(5,996) | | | $(22,054) |
Weighted-average shares outstanding, basic and diluted | | | 3,648,367 | | | 3,659,456 | | | 3,659,283 | | | 3,709,020 |
Net loss attributable to common stockholders per share, basic and diluted | | | $(2.09) | | | $(2.72) | | | $(1.64) | | | $(5.95) |
Pro forma weighted-average shares outstanding, basic and diluted (unaudited) | | | | | 10,800,776 | | | | | 23,282,725 | ||
Pro forma net loss attributable to common stockholders per share, basic and diluted (unaudited) | | | | | $(0.92) | | | | | $(0.95) |
| | As of September 30, 2020 | |||||||
| | Actual | | | Pro Forma(1) | | | Pro Forma As Adjusted(2)(3) | |
| | (unaudited) | |||||||
| | (in thousands) | |||||||
Balance Sheet Data: | | | | | | | |||
Cash and cash equivalents | | | $156,859 | | | $156,859 | | | $351,845 |
Working capital(4) | | | 150,780 | | | 150,780 | | | 345,766 |
Total assets | | | 159,197 | | | 159,197 | | | 354,183 |
Current liabilities | | | 6,699 | | | 6,699 | | | 6,699 |
Total liabilities | | | 6,699 | | | 6,699 | | | 6,699 |
Convertible preferred stock | | | 190,835 | | | — | | | — |
Accumulated deficit | | | (39,622) | | | (39,622) | | | (39,622) |
Total stockholders’ equity (deficit) | | | (38,337) | | | 152,498 | | | 347,484 |
(1) | The pro forma balance sheet data gives effect to the automatic conversion of all outstanding shares of our convertible preferred stock into an aggregate of 25,778,437 shares of our common stock which will occur immediately prior to the completion of this offering, resulting in an aggregate of 29,527,219 outstanding shares of our common stock. |
(2) | The pro forma as adjusted column in the balance sheet data table above gives effect to (i) the pro forma adjustments described in footnote (1) above and (ii) the issuance and sale of 11,500,000 shares of common stock in this offering at the assumed initial public offering price of $18.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
(3) | Each $1.00 increase or decrease in the assumed initial public offering price of $18.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, the pro forma as adjusted amount of each of our cash and cash equivalents, working capital, total assets and stockholders’ equity (deficit) by $10.7 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of shares offered by us at the assumed initial public offering price would increase or decrease, as applicable, each of our cash and cash equivalents, working capital, total assets, and stockholders’ equity (deficit) by $17.2 million. The pro forma as adjusted information set forth above is illustrative only and will depend on the actual initial public offering price and other terms of this offering determined at pricing. |
(4) | We define working capital as current assets less current liabilities. See our financial statements appearing elsewhere in this prospectus for further details regarding our current assets and current liabilities. |
• | successful and timely completion of preclinical and clinical development of product candidates from our RAF and FGFR programs, our CDK12 and other research programs, and any other future programs; |
• | establishing and maintaining relationships with contract research organizations (CROs) and clinical sites for the clinical development of product candidates from our RAF and FGFR programs, our CDK12 and other research programs, and any other future programs; |
• | timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development; |
• | developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale; |
• | establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved; |
• | successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; |
• | a continued acceptable safety profile following any marketing approval of our product candidates; |
• | commercial acceptance of our product candidates by patients, the medical community and third-party payors; |
• | satisfying any required post-marketing approval commitments to applicable regulatory authorities; |
• | identifying, assessing and developing new product candidates; |
• | obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |
• | defending against third-party interference or infringement claims, if any; |
• | entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
• | obtaining coverage and adequate reimbursement by third-party payors for our product candidates; |
• | addressing any competing therapies and technological and market developments; and |
• | attracting, hiring and retaining qualified personnel. |
• | successful and timely completion of preclinical studies; |
• | approval of INDs for our planned clinical trials and future clinical trials; |
• | addressing any potential delays resulting from factors related to the COVID-19 pandemic; |
• | successful initiation and completion of clinical trials; |
• | successful and timely patient selection and enrollment in and completion of clinical trials; |
• | maintaining and establishing relationships with CROs and clinical sites for the clinical development of our product candidates both in the United States and internationally; |
• | the frequency and severity of adverse events in clinical trials; |
• | demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any comparable foreign regulatory authority for marketing approval; |
• | the timely receipt of marketing approvals from applicable regulatory authorities; |
• | the timely identification, development and approval of companion diagnostic tests, if required; |
• | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |
• | the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of our product candidates; |
• | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |
• | the protection of our rights in our intellectual property portfolio; |
• | the successful launch of commercial sales following any marketing approval; |
• | a continued acceptable safety profile following any marketing approval; |
• | commercial acceptance by patients, the medical community and third-party payors; and |
• | our ability to compete with other therapies. |
• | failure of our product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy; |
• | receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; |
• | negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research and/or drug development programs; |
• | the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated; |
• | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks; |
• | the cost of clinical trials of our product candidates being greater than anticipated; |
• | the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and |
• | regulators revising the requirements for approving our product candidates. |
• | generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials; |
• | addressing any delays resulting from factors related to the COVID-19 pandemic; |
• | obtaining regulatory permission to initiate clinical trials; |
• | contracting with the necessary parties to conduct clinical trials; |
• | successful enrollment of patients in, and the completion of, clinical trials on a timely basis; |
• | the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and |
• | adverse events in clinical trials. |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
• | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; |
• | the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for our product candidates; and |
• | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | size and nature of the patient population; |
• | severity of the disease under investigation; |
• | availability and efficacy of approved drugs for the disease under investigation; |
• | patient eligibility criteria for the trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have biomarker-driven patient eligibility criteria; |
• | perceived risks and benefits of the product candidate under study; |
• | clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other product candidates being investigated for the indications we are investigating; |
• | clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials; |
• | patient referral practices of physicians; |
• | the ability to monitor patients adequately during and after treatment; |
• | proximity and availability of clinical trial sites for prospective patients; and |
• | the risk that patients enrolled in clinical trials will drop out of the trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials. |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | delays or difficulties in enrolling and retaining patients in any clinical trials, particularly elderly subjects, who are at a higher risk of severe illness or death from COVID-19; |
• | difficulties interpreting data from our clinical trials due to the possible effects of COVID-19 on patients; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others; |
• | interruption or delays in the operations of the FDA, EMA or other regulatory authorities, which may impact review and approval timelines; |
• | limitations in resources that would otherwise be focused on the conduct of our business, our preclinical studies or our clinical trials, including because of sickness or the desire to avoid contact with large groups of people or as a result of government-imposed “shelter in place” or similar working restrictions; |
• | interruptions, difficulties or delays arising in our existing operations and company culture as a result of all of our employees working remotely, including those hired during the COVID-19 pandemic; |
• | delays in receiving approval from regulatory authorities to initiate our clinical trials; |
• | delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies; |
• | interruption in global freight and shipping that may affect the transport of clinical trial materials, such as investigational drug product to be used in our clinical trials; |
• | changes in regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are to be conducted, or to discontinue the clinical trials altogether, or which may result in unexpected costs; |
• | delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and |
• | refusal of the FDA, EMA or other regulatory authorities to accept data from clinical trials in affected geographies outside of their respective jurisdictions. |
• | the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments; |
• | the timing of market introduction of the product candidate as well as competitive products; |
• | the clinical indications for which a product candidate is approved; |
• | restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products; |
• | the potential and perceived advantages of our product candidates over alternative treatments; |
• | the cost of treatment in relation to alternative treatments; |
• | the availability of coverage and adequate reimbursement by third-party payors, including government authorities; |
• | the availability of an approved product candidate for use as a combination therapy; |
• | relative convenience and ease of administration; |
• | the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests; |
• | the effectiveness of sales and marketing efforts; |
• | unfavorable publicity relating to our product candidates; and |
• | the approval of other new therapies for the same indications. |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
• | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use; |
• | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval; |
• | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials; |
• | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
• | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | delays in or the rejection of product approvals; |
• | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
• | restrictions on the products, manufacturers or manufacturing process; |
• | warning or untitled letters; |
• | civil and criminal penalties; |
• | injunctions; |
• | suspension or withdrawal of regulatory approvals; |
• | product seizures, detentions or import bans; |
• | voluntary or mandatory product recalls and publicity requirements; |
• | total or partial suspension of production; |
• | imposition of restrictions on operations, including costly new manufacturing requirements; |
• | revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; |
• | imposition of a REMS, which may include distribution or use restrictions; and |
• | requirements to conduct additional post-market clinical trials to assess the safety of the product. |
• | the demand for our product candidates, if we obtain regulatory approval; |
• | our ability to set a price that we believe is fair for our products; |
• | our ability to obtain coverage and reimbursement approval for a product; |
• | our ability to generate revenue and achieve or maintain profitability; |
• | the level of taxes that we are required to pay; and |
• | the availability of capital. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute |
• | federal civil and criminal false claims laws, including the FCA, which can be enforced through civil “qui tam” or “whistleblower” actions, and civil monetary penalty laws, impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent; knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the federal civil FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; |
• | HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (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, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information as well as their covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; |
• | the federal Physician Payments Sunshine Act, created under the ACA and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include payments and transfers of value made and ownership interests held during the previous year to certain non-physician providers such as physician assistants and nurse practitioners; and |
• | analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by |
• | identifying, recruiting, integrating, maintaining, retaining and motivating our current and additional employees; |
• | managing our internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory agencies’ review process for our RAF and FGFR programs and our other product candidates, while complying with any contractual obligations to contractors and other third parties; |
• | managing increasing operational and managerial complexity; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being more costly than obtaining approval in the United States; |
• | foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from nonclinical studies or clinical trials; |
• | approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; |
• | impact of the COVID-19 pandemic on our ability to produce our product candidates and conduct clinical trials in foreign countries; |
• | unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with legal requirements applicable to privacy, data protection, information security and other matters; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; |
• | difficulties staffing and managing foreign operations; |
• | complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | potential liability under the FCPA or comparable foreign regulations; |
• | challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geo-political actions, including war and terrorism, trade policies, treaties and tariffs. |
• | the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; |
• | patent applications may not result in any patents being issued; |
• | patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; |
• | our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates; |
• | there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and |
• | countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates. |
• | others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license; |
• | we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that we own or license; |
• | we or our future licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
• | it is possible that the pending patent applications we own or license will not lead to issued patents; |
• | issued patents that we own or license may be held invalid or unenforceable, as a result of legal challenges by our competitors; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; |
• | the patents of others may have an adverse effect on our business; and |
• | we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property. |
• | result in costly litigation that may cause negative publicity; |
• | divert the time and attention of our technical personnel and management; |
• | cause development delays; |
• | prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law; |
• | require us to develop non-infringing technology, which may not be possible on a cost-effective basis; |
• | subject us to significant liability to third parties; or |
• | require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | our right to sublicense patents and other rights to third parties; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | our right to transfer or assign the license; |
• | the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners; and |
• | the priority of invention of patented technology. |
• | the failure of the third party to manufacture our product candidates according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them; |
• | the reduction or termination of production or deliveries by suppliers, or the raising or prices or renegotiation of terms; |
• | the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us; |
• | the breach by the third-party contractors of our agreements with them; |
• | the failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs; |
• | the breach by the third-party contractors of our agreements with them; |
• | the failure of the third party to manufacture our product candidates according to our specifications; |
• | the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; |
• | clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and |
• | the misappropriation of our proprietary information, including our trade secrets and know-how. |
• | increased operating expenses and cash requirements; |
• | the assumption of additional indebtedness or contingent liabilities; |
• | the issuance of our equity securities; |
• | assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel; |
• | the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition; |
• | retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships; |
• | risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and |
• | our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs. |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected; |
• | collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization |
• | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
• | collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely |
• | to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
• | a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; |
• | we may grant exclusive rights to our collaborators that would prevent us from collaborating with others; |
• | collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; |
• | disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources; |
• | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; |
• | collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; |
• | collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates; |
• | collaborators may own or co-own intellectual property covering our products or product candidates that result from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and |
• | a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. |
• | the timing and results of INDs, preclinical studies and clinical trials of our product candidates or those of our competitors; |
• | the success of competitive products or announcements by potential competitors of their product development efforts; |
• | regulatory actions with respect to our products or product candidates or our competitors’ products or product candidates; |
• | actual or anticipated changes in our growth rate relative to our competitors; |
• | regulatory or legal developments in the United States and other countries; |
• | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
• | the recruitment or departure of key personnel; |
• | announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments; |
• | actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | market conditions in the pharmaceutical and biotechnology sector; |
• | changes in the structure of healthcare payment systems; |
• | share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; |
• | announcement or expectation of additional financing efforts; |
• | sales of our common stock by us, our insiders or our other stockholders; |
• | expiration of market stand-off or lock-up agreements; |
• | the impact of any natural disasters or public health emergencies, such as the COVID-19 pandemic; and |
• | general economic, political, industry and market conditions, including the presidential election in the United States in 2020. |
• | the timing and cost of, and level of investment in, research and development activities relating to our programs, which will change from time to time; |
• | our ability to enroll patients in clinical trials and the timing of enrollment; |
• | the cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements, the quantity of production and the terms of our agreements with manufacturers; |
• | expenditures that we will or may incur to acquire or develop additional product candidates and technologies or other assets; |
• | the timing and outcomes of preclinical studies and clinical trials for product candidates from our RAF and FGFR programs, and any product candidates from our research programs, or competing product candidates; |
• | the need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated; |
• | competition from existing and potential future products that compete with our RAF or FGFR programs or any of our research programs, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners; |
• | any delays in regulatory review or approval of product candidates from our RAF or FGFR programs, or any of our research programs; |
• | the level of demand for any of our product candidates, if approved, which may fluctuate significantly and be difficult to predict; |
• | the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future products that compete with our RAF or FGFR programs, or any of our research programs; |
• | our ability to commercialize product candidates from our RAF or FGFR programs, or any of our research programs, if approved, inside and outside of the United States, either independently or working with third parties; |
• | our ability to establish and maintain collaborations, licensing or other arrangements; |
• | our ability to adequately support future growth; |
• | potential unforeseen business disruptions that increase our costs or expenses; |
• | future accounting pronouncements or changes in our accounting policies; and |
• | the changing and volatile global economic and political environment. |
• | being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in this prospectus; |
• | not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (Sarbanes-Oxley Act); |
• | not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; |
• | reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements; and |
• | exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved. |
• | 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; |
• | authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a “poison pill”); |
• | 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; |
• | authorize our board of directors to amend the bylaws; |
• | 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; and |
• | require a super-majority vote of stockholders to amend some provisions described above. |
• | any derivative action or proceeding brought on our behalf; |
• | any action asserting a claim of breach of fiduciary duty; |
• | any action asserting a claim against us arising under the DGCL, our amended- and restated certificate of incorporation or our amended and restated bylaws; and |
• | any action asserting a claim against us that is governed by the internal-affairs doctrine. |
• | the ability of our preclinical studies and planned clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
• | the timing, progress and results of preclinical studies and planned clinical trials for our current product candidates and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the studies or trials will become available, and our research and development programs; |
• | the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs and final FDA approval of our current product candidates and any other future product candidates; |
• | the timing, scope or likelihood of foreign regulatory filings and approvals; |
• | our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies; |
• | our manufacturing, commercialization, and marketing capabilities and strategy; |
• | our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; |
• | the need to hire additional personnel and our ability to attract and retain such personnel; |
• | the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; |
• | our expectations regarding the approval and use of our product candidates in combination with other drugs; |
• | our competitive position and the success of competing therapies that are or may become available; |
• | our estimates of the number of patients that we will enroll in our clinical trials; |
• | the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates; |
• | our ability to obtain and maintain regulatory approval of our product candidates; |
• | our plans relating to the further development of our product candidates, including additional indications we may pursue; |
• | existing regulations and regulatory developments in the United States, Europe and other jurisdictions; |
• | our expectations regarding the impact of the COVID-19 pandemic on our business; |
• | our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; |
• | our continued reliance on third parties to conduct additional preclinical studies and planned clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; |
• | our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
• | the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved; |
• | the rate and degree of market acceptance and clinical utility of our current product candidates and other product candidates we may develop; |
• | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
• | our financial performance; |
• | the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; |
• | the impact of laws and regulations; |
• | our expectations regarding the period during which we will remain an emerging growth company under the JOBS Act; and |
• | our anticipated use of our existing resources and the net proceeds from this offering. |
• | approximately $110.0 million to fund the continued development of our RAF program, including: |
○ | approximately $50.0 million to initiate and complete our planned Phase 1 clinical trial of our most advanced product candidate, KIN002787, |
○ | approximately $40.0 million in preparations for additional clinical trials of KIN002787, including manufacturing costs and preparation of regulatory filings, and |
○ | approximately $20.0 million to fund the continued development of other product candidates in our RAF program; |
• | approximately $55.0 million to fund the continued development of our KIN003 program evaluating FGFR inhibitor candidates through the nomination of a lead product candidate, completion of IND-enabling studies for such product candidate, and initiation and completion of our planned Phase 1 clinical trial for such product candidate; and |
• | the remaining amounts to fund the continued development of our other research programs, as well as for working capital and other general corporate purposes. |
• | on an actual basis; |
• | on a pro forma basis to reflect (i) the automatic conversion of all outstanding shares of our convertible preferred stock into an aggregate of 25,778,437 shares of common stock immediately prior to the completion of this offering and (ii) the filing and effectiveness of our amended and restated certificate of incorporation, which will occur immediately prior to the completion of this offering; and |
• | on a pro forma as adjusted basis to reflect (i) the pro forma adjustments set forth above and (ii) our issuance and sale of 11,500,000 shares of common stock in this offering at the assumed initial public offering price of $18.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
| | As of September 30, 2020 | |||||||
| | Actual | | | Pro Forma | | | Pro Forma As Adjusted(1) | |
| | (unaudited) | |||||||
| | (in thousands, except per share amounts) | |||||||
Cash and cash equivalents | | | $156,859 | | | $156,859 | | | $351,845 |
Convertible preferred stock, $0.0001 par value per share; 25,750,721 shares authorized, 25,750,698 shares issued and outstanding, actual; no shares authorized, issued or outstanding, pro forma and pro forma as adjusted | | | $190,835 | | | $— | | | $— |
Stockholders’ equity (deficit): | | | | | | | |||
Preferred stock, $0.0001 par value per share; no shares authorized, issued and outstanding, actual; 200,000,000 shares authorized, no shares issued and outstanding, pro forma and pro forma as adjusted | | | — | | | — | | | — |
Common stock, $0.0001 par value per share; 38,071,168 shares authorized, 3,777,997 shares issued and 3,748,782 outstanding, actual; 1,000,000,000 shares authorized, 29,527,219 shares issued and outstanding, pro forma; 1,000,000,000 shares authorized, 41,027,219 shares issued and outstanding, pro forma as adjusted | | | — | | | 3 | | | 4 |
Additional paid-in capital | | | 1,360 | | | 192,192 | | | 387,177 |
Treasury stock at cost, 29,215 shares of common stock | | | (75) | | | (75) | | | (75) |
Accumulated deficit | | | (39,622) | | | (39,622) | | | (39,622) |
Total stockholders’ equity (deficit) | | | (38,337) | | | 152,498 | | | 347,484 |
Total capitalization | | | $152,498 | | | $152,498 | | | $347,484 |
(1) | Each $1.00 increase or decrease in the assumed initial public offering price of $18.50 per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease, as applicable, each of our pro forma as adjusted cash and cash equivalents, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization by approximately $10.7 million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of shares of common stock offered by us would increase or decrease, as applicable, each of our pro forma as adjusted cash and cash |
• | 5,700,154 shares of common stock issuable upon the exercise of options outstanding as of September 30, 2020, with a weighted-average exercise price of $3.08 per share; |
• | 546,759 shares of common stock issuable upon the exercise of options granted after September 30, 2020, with a weighted-average exercise price of $8.39 per share; |
• | 1,117,217 shares of common stock for future issuance under our 2018 Equity Incentive Plan, as amended (2018 Plan), as of September 30, 2020, which shares will be added to the shares to be reserved for future issuance under our 2020 Equity Incentive Plan (2020 Plan); |
• | 5,218,000 shares of common stock reserved for future issuance under our 2020 Plan (which does not give effect to the grant of 121,503 shares of common stock issuable upon the exercise of stock options which will be granted, as of the effective date of the registration statement of which this prospectus forms a part, under our 2020 Plan, at an exercise price equal to the initial public offering price of our common stock), which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, as well as any automatic increases in the number of shares of common stock reserved for future issuance under this plan; and |
• | 435,000 shares of common stock reserved for future issuance under our 2020 Employee Stock Purchase Plan (2020 ESPP), which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, as well as any automatic increases in the number of shares of common stock reserved for future issuance under this plan. |
Assumed initial public offering price per share | | | | | $18.50 | |
Historical net tangible book value (deficit) per share as of September 30, 2020 | | | $(10.23) | | | |
Pro forma increase in net tangible book value per share as of September 30, 2020 | | | 15.39 | | | |
Pro forma net tangible book value per share as of September 30, 2020 | | | 5.16 | | | |
Increase in pro forma net tangible book value per share attributable to investors purchasing shares of common stock in this offering | | | 3.31 | | | |
Pro forma as adjusted net tangible book value per share | | | | | 8.47 | |
Dilution per share to investors participating in this offering | | | | | $10.03 |
| | Shares Purchased | | | Total Consideration | | | Weighted- Average Price Per Share | |||||||
| | Number | | | Percent | | | Amount | | | Percent | | |||
Existing stockholders before this offering | | | 29,527,219 | | | 72.0% | | | $190,835,000 | | | 47.3% | | | $6.46 |
Investors purchasing shares in this offering | | | 11,500,000 | | | 28.0% | | | 212,750,000 | | | 52.7% | | | $18.50 |
Total | | | 41,027,219 | | | 100.0% | | | $403,585,000 | | | 100.0% | | |
• | 5,700,154 shares of common stock issuable upon the exercise of options outstanding as of September 30, 2020, with a weighted-average exercise price of $3.08 per share; |
• | 546,759 shares of common stock issuable upon the exercise of options granted after September 30, 2020, with a weighted-average exercise price of $8.39 per share; |
• | 1,117,217 shares of common stock for future issuance under our 2018 Plan as of September 30, 2020, which shares will be added to the shares to be reserved for future issuance under our 2020 Plan; |
• | 5,218,000 shares of common stock reserved for future issuance under our 2020 Plan (which does not give effect to the grant of 121,503 shares of common stock issuable upon the exercise of stock options which will be granted, as of the effective date of the registration statement of which this prospectus forms a part, under our 2020 Plan, at an exercise price equal to the initial public offering price of our common stock), which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, as well as any automatic increases in the number of shares of common stock reserved for future issuance under this plan; and |
• | 435,000 shares of common stock reserved for future issuance under our 2020 ESPP, which will become effective on the business day immediately prior to the date of effectiveness of the registration statement of which this prospectus forms a part, as well as any automatic increases in the number of shares of common stock reserved for future issuance under this plan. |
| | Period from January 4, 2018 (inception) through December 31, 2018 | | | Year Ended December 31, 2019 | | | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |||||||
| | | | | | (unaudited) | ||||||
| | (in thousands, except share and per share amounts) | ||||||||||
Statements of Operations Data: | | | | | | | | | ||||
Operating expenses: | | | | | | | | | ||||
Research and development (includes related party amounts of $1,454, $2,301, $1,551 and $0, respectively) | | | $5,675 | | | $8,955 | | | $5,896 | | | $17,261 |
General and administrative (includes related party amounts of $1,600, $2,609, $1,827 and $92, respectively) | | | 1,955 | | | 3,057 | | | 2,131 | | | 5,021 |
Total operating expenses | | | 7,630 | | | 12,012 | | | 8,027 | | | 22,282 |
Loss from operations | | | (7,630) | | | (12,012) | | | (8,027) | | | (22,282) |
Other income: | | | | | | | | | ||||
Interest income | | | — | | | 43 | | | — | | | 228 |
Total other income | | | — | | | 43 | | | — | | | 228 |
Net loss and comprehensive loss | | | $(7,630) | | | $(11,969) | | | $(8,027) | | | $(22,054) |
Gain on extinguishment of Series A convertible preferred stock | | | — | | | 2,031 | | | 2,031 | | | — |
Net loss attributable to common stockholders | | | $(7,630) | | | $(9,938) | | | $(5,996) | | | $(22,054) |
Weighted-average shares outstanding, basic and diluted | | | 3,648,367 | | | 3,659,456 | | | 3,659,283 | | | 3,709,020 |
Net loss attributable to common stockholders per share, basic and diluted | | | $(2.09) | | | $(2.72) | | | $(1.64) | | | $(5.95) |
Pro forma weighted-average shares outstanding, basic and diluted (unaudited) | | | | | 10,800,776 | | | | | 23,282,725 | ||
Pro forma net loss attributable to common stockholders per share, basic and diluted (unaudited) | | | | | $(0.92) | | | | | $(0.95) |
| | As of December 31, | | | As of September 30, 2020 | ||||
| | 2018 | | | 2019 | | |||
| | | | | | (unaudited) | |||
| | (in thousands) | |||||||
Balance Sheet Data: | | | | | | | |||
Cash and cash equivalents | | | $6,999 | | | $76,453 | | | $156,859 |
Working capital(1) | | | 7,610 | | | 75,506 | | | 150,780 |
Total assets | | | 8,077 | | | 77,605 | | | 159,197 |
Current liabilities | | | 467 | | | 1,945 | | | 6,699 |
Total liabilities | | | 467 | | | 1,945 | | | 6,699 |
Convertible preferred stock | | | — | | | 93,146 | | | 190,835 |
Accumulated deficit | | | (7,630) | | | (17,568) | | | (39,622) |
Total stockholders’ equity (deficit) | | | 7,610 | | | (17,486) | | | (38,337) |
(1) | We define working capital as current assets less current liabilities. See our financial statements appearing elsewhere in this prospectus for further details regarding our current assets and current liabilities. |
• | advance our RAF and FGFR programs from discovery and preclinical development into and through clinical development; |
• | advance the development of our other small molecule research programs, including our CDK12 inhibitor; |
• | expand our pipeline of product candidates through our own product discovery and development efforts; |
• | seek to discover and develop additional product candidates; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs; |
• | implement operational, financial and management systems; |
• | attract, hire and retain additional clinical, scientific, management and administrative personnel; |
• | maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and |
• | operate as a public company. |
• | expenses incurred in connection with the discovery and preclinical development of our product candidates, including under agreements with third parties, such as consultants and CROs; |
• | the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and CMOs; and |
• | costs associated with consultants for chemistry, manufacturing and controls (CMC) development, regulatory, statistics and other services. |
• | for 2020, employee-related expenses, including salaries and benefits, travel and stock-based compensation expense for employees engaged in research and development functions; and |
• | for 2019, research and development services provided by FSC and stock-based compensation expense. |
• | the timing and progress of preclinical and clinical development activities; |
• | the number and scope of preclinical and clinical programs we decide to pursue; |
• | our ability to maintain our current research and development programs and to establish new ones; |
• | establishing an appropriate safety profile with IND-enabling toxicology studies; |
• | successful patient enrollment in, and the initiation and completion of, clinical trials; |
• | per subject trial costs; |
• | the number of trials required for regulatory approval; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible subjects and initial clinical trials; |
• | the number of subjects that participate in the trials; |
• | 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 successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities; |
• | the receipt of regulatory approvals from applicable regulatory authorities; |
• | the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities; |
• | the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party; |
• | obtaining and retaining research and development personnel; |
• | establishing commercial manufacturing capabilities or making arrangements with CMOs; |
• | development and timely delivery of commercial-grade drug formulations that can be used in our planned clinical trials and for commercial launch; and |
• | obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights. |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
| | (in thousands) | ||||
Operating expenses: | | | | | ||
Research and development (includes related party amounts of $1,551 and $0, respectively) | | | $5,896 | | | $17,261 |
General and administrative (includes related party amounts of $1,827 and $92, respectively) | | | 2,131 | | | 5,021 |
Total operating expenses | | | 8,027 | | | 22,282 |
Loss from operations | | | (8,027) | | | (22,282) |
Other Income: | | | | | ||
Interest income | | | — | | | 228 |
Total other income | | | — | | | 228 |
Net loss and comprehensive loss | | | $(8,027) | | | $(22,054) |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
| | (in thousands) | ||||
External expenses: | | | | | ||
Lead programs(1) | | | $2,777 | | | $11,785 |
Other programs and other unallocated costs | | | 1,568 | | | 2,082 |
Total external expenses | | | 4,345 | | | 13,867 |
Internal expenses | | | 1,551 | | | 3,394 |
Total research and development expenses | | | $5,896 | | | $17,261 |
(1) | For the periods presented, consists of our RAF and FGFR programs. |
| | For the Period January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
| | (in thousands) | ||||
Operating expenses: | | | | | ||
Research and development (includes related party amounts of $1,454 and $2,301, respectively) | | | $5,675 | | | $8,955 |
General and administrative (includes related party amounts of $1,600 and $2,609, respectively) | | | 1,955 | | | 3,057 |
Total operating expenses | | | 7,630 | | | 12,012 |
Loss from operations | | | (7,630) | | | (12,012) |
Other Income: | | | | | ||
Interest income | | | — | | | 43 |
Total other income | | | — | | | 43 |
Net loss and comprehensive loss | | | $(7,630) | | | $(11,969) |
| | For the Period January 4,2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
| | (in thousands) | ||||
External expenses: | | | | | ||
Lead programs(1) | | | $378 | | | $4,500 |
Other programs and other unallocated costs | | | 3,806 | | | 2,120 |
Total external expenses | | | 4,184 | | | 6,620 |
Internal expenses | | | 1,491 | | | 2,335 |
Total research and development expenses | | | $5,675 | | | $8,955 |
(1) | For the periods presented, consists of our RAF and FGFR programs. |
• | advance our RAF and FGFR programs from discovery and preclinical development into and through clinical development; |
• | advance the development of our other small molecule research programs, including our CDK12 inhibitor; |
• | expand our pipeline of product candidates through our own product discovery and development efforts; |
• | seek to discover and develop additional product candidates; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs; |
• | implement operational, financial and management systems; |
• | attract, hire and retain additional clinical, scientific, management and administrative personnel; |
• | maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and |
• | operate as a public company. |
• | the scope, timing, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials; |
• | the scope, timing, progress, results and costs of researching and developing other product candidates that we may pursue; |
• | the costs, timing and outcome of regulatory review of our product candidates; |
• | the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval; |
• | the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch; |
• | the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval; |
• | the cost and timing of attracting, hiring and retaining skilled personnel to support our operations and continued growth; |
• | the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; |
• | our ability to establish and maintain collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties on favorable terms, if at all; |
• | the extent to which we acquire or in-license other product candidates and technologies, if any; |
• | the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any; and |
• | the costs associated with operating as a public company. |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
| | (in thousands) | ||||
Net cash used in operating activities | | | $(7,180) | | | $(16,405) |
Net cash used in investing activities | | | — | | | (359) |
Net cash provided by financing activities | | | 5,930 | | | 97,170 |
Net (decrease) increase in cash and cash equivalents | | | $(1,250) | | | $80,406 |
| | Period from January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
| | (in thousands) | ||||
Net cash used in operating activities | | | $(8,202) | | | $(10,526) |
Net cash provided by financing activities | | | 15,201 | | | 79,980 |
Net increase in cash and cash equivalents | | | $6,999 | | | $69,454 |
• | Fair Value of Common Stock—See the subsection titled “—Determination of the Fair Value of Common Stock” below. |
• | Expected Term—We have opted to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option, which is generally 10 years. |
• | Expected Volatility—Due to our limited operating history and a lack of company-specific historical and implied volatility data, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. We will continue to apply this process until a sufficient amount of historical information regarding the volatility of our own stock price becomes available. |
• | Risk-Free Interest Rate—The risk-free interest rates used are based on the U.S. Treasury yield in effect at the time of grant for zero-coupon U.S. treasury notes with maturities approximately equal to the expected term of the stock options. |
• | Expected Dividend—To date, we have not issued any dividends and do not expect to issue dividends over the life of the options and therefore have estimated the dividend yield to be zero. |
• | Probability-Weighted Expected Return Method. The probability-weighted expected return method (PWERM) is a scenario-based analysis that estimates the fair value of common stock based upon an analysis of future values for the business, assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns considering each of the possible forecasted outcomes as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at a non-marketable indication of value for the common stock. |
• | Option Pricing Method. Under the option pricing method (OPM), shares are valued by creating a series of call options, representing the present value of the expected future returns to the stockholders, with exercise prices based on the liquidation preferences and conversion terms of each equity class. The estimated fair values of the preferred and common stock are inferred by analyzing these options. |
• | Hybrid Return Method. The Hybrid Return Method is a blended approach using aspects of both the PWERM and OPM, in which the equity value in one of the scenarios is calculated using an OPM. |
• | the prices at which we sold shares of our convertible preferred stock to outside investors in arms-length transactions, and the superior rights, preferences and privileges of the preferred stock relative to our common stock at the time of each grant; |
• | the progress of our research and development programs, including their stage of development, and our business strategy; |
• | external market and other conditions affecting the biotechnology industry, and trends within the biotechnology industry; |
• | our financial position, including cash on hand, and our historical and forecasted performance and operating results; |
• | the lack of an active public market for our common stock; |
• | the likelihood of achieving a liquidity event for our securityholders, such as an initial public offering or a sale of our company, taking into consideration prevailing market conditions; |
• | the hiring of key personnel and the experience of management; and |
• | the analysis of initial public offerings and the market performance of peer companies in the biopharmaceutical industry, as well as completed mergers and acquisitions of peer companies. |
• | Structure-based drug discovery. Through our integrated biology and chemistry approach led by experts in small molecule kinase inhibitors, we identify compounds with a high probability of success in inhibiting selective kinase targets. |
• | Translational research. We employ a biomarker-driven approach to predict and increase the likelihood of therapeutic response to our product candidates in patients. |
• | Patient-driven precision medicine. Capitalizing on next-generation sequencing (NGS) technologies and guidance from leaders at experienced precision medicine cancer centers, we define emerging patient populations for our product candidates. |
• | Rapidly advance the development of our lead targeted therapy RAF and FGFR candidates. Our lead product candidates are designed to address clinically validated cancer targets in patient populations with limited treatment options. Our candidates are designed to address either Class II and Class III BRAF mutations or FGFR2 and FGFR3 genomic alterations. We believe that these small molecule candidates offer the potential for substantial clinical benefit when administered as monotherapy. Additionally, because of their enhanced pharmacological properties, we believe there may be future opportunities for combination therapy development. We anticipate filing an IND for KIN002787 with the FDA in the first half of 2021 and, subject to such submission taking effect, initiating a Phase 1 clinical trial in 2021. We plan to nominate a lead product candidate in our KIN003 program in 2021, file an IND with the FDA in the first half of 2022 and, subject to such submission taking effect, initiate a Phase 1 clinical trial in the first half of 2022. |
• | Develop a pipeline of product candidates focused on overcoming the limitations of current targeted oncology therapeutics. Currently, it is estimated that only 10% of all patients with advanced or metastatic cancer today are eligible for commercially available small molecule kinase inhibitors. Additionally, up to half of these patients may not respond to these treatments and up to half of those who do initially respond may develop resistance. Ultimately, it is estimated that only 2% to 3% of patients with advanced or metastatic cancer will have durable responses to currently available targeted therapeutics. We are therefore focused on developing drugs that can: |
○ | Target known oncogenic drivers (e.g., Class II or Class III BRAF mutations) in selected cancer types that are not currently addressed by approved therapies. Our BRAF-targeting small molecule kinase inhibitors exemplify this strategy. The successful development and FDA approval of three BRAF-targeted kinase inhibitor drugs for use in Class I BRAF mutations establishes BRAF as a validated cancer drug target. |
○ | Overcome acquired resistance mutations to existing targeted therapies, potentially improving the durability of response. For example, in our FGFR program we seek to develop targeted therapies that cover initial genomic alterations and preemptively address acquired resistance mutations that arise with current targeted therapies. |
○ | Treat non-responders to currently approved therapies where advancements in next generation sequencing have identified, and will continue to reveal, genomic drivers of intrinsic resistance. We expect to develop our CDK12 inhibitor and future programs that will target mechanisms of intrinsic resistance. |
• | Increase our probability of clinical success by prioritizing known oncogenic drivers for development and incorporating biomarkers into preclinical and clinical development. Typically, drug development carries high attrition rates from the preclinical stage through FDA approval, with some studies showing that only approximately 10% of the candidates entering Phase 1 trials are ultimately approved. We aim to improve the probability of clinical success through several approaches: |
○ | Targeting known oncogenic drivers. We attempt to select targets for drug development that behave as oncogenic drivers, which increases the likelihood of seeing objective measures of tumor responses early in clinical development. If we are successful in inhibiting these targets with our product candidates, we may increase the likelihood of achieving tumor responses. This approach has been successful for kinase inhibitors designed to treat patients with oncogenic alterations in lung cancer, melanoma, leukemia and other types of cancer. |
○ | Developing small molecule kinase inhibitors. Small molecule kinase inhibitors are a proven modality that has demonstrated success in the past with multiple currently approved drugs across many solid tumor and hematologic malignancy indications. By testing our molecules against in vitro and in vivo models utilized by prior approved drugs, we believe we can efficiently benchmark and optimize our compounds. |
○ | Incorporating biomarkers into our preclinical and clinical development. By evaluating a wide range of biomarkers in our preclinical studies and our human clinical trials, we can more rapidly determine patient populations that may or may not respond to our candidates. Continuing to use biomarkers in clinical trials allows us to potentially select defined patient populations that may demonstrate a stronger benefit and thereby ultimately increase our probability of success. |
• | Leverage our existing relationships, collaborations and experience to efficiently develop and expand our product portfolio. Our team has extensive experience in identifying, discovering, developing and commercializing innovative cancer therapeutics. We are combining this broad oncology expertise with a network of collaborators to further develop our existing pipeline as well as to identify new research and development opportunities. We have established deep collaborations with leaders, with whom we have advisory agreements, at experienced precision medicine cancer centers and research institutions, including Massachusetts General Hospital Cancer Center, with whom we have a sponsored research agreement, Memorial Sloan Kettering Cancer Center and Moores Cancer Center at UCSD. These collaborations allow us to explore the mechanistic understanding of the biology of our targets and sensitivity and resistance to our molecules. We have also leveraged our relationships to build a network of global external partners to advance our pipeline. For example, we have service agreements with academic and industrial partners who contribute highly enabling technologies and services that include: (1) over 60 medicinal chemists at leading CROs, (2) bioinformatics support for our translational research efforts, (3) crystallography and biophysical assay platforms to enable structure-based drug discovery, (4) biochemical and cell-based assays to guide lead generation and optimization, and (5) patient-derived organoid and xenograft models to translate our findings to the clinical setting. We utilize these collaborations and partnerships in many aspects of preclinical development for our pipeline of candidates and anticipate further utilizing them in our clinical development efforts. Additionally, these collaborations and partnerships may allow us to accelerate identification of new opportunities, including new patient populations we may target to understand emerging mechanisms of resistance. |
• | Maximize the clinical impact and value of our portfolio. We retain full global development and commercialization rights to our pipeline of candidates. We intend to build an integrated biopharmaceutical company that will manage all aspects of product development and commercialization globally. We may seek to develop rational combination therapy strategies among products within our own portfolio, while also maximizing portfolio value through selective co-development and/or commercialization collaborations. |
• | Structure-based drug discovery. Through our integrated biology and chemistry approach led by experts in small molecule kinase inhibitors, we identify compounds with a high probability of success in inhibiting selective kinase targets. |
• | Translational research. We employ a biomarker-driven approach to predict and increase the likelihood of therapeutic response to our product candidates in patients. |
• | Patient-driven precision medicine. Capitalizing on NGS technologies and guidance from leaders at experienced precision medicine cancer centers, we define emerging patient populations for our product candidates. |
• | Precision oncology and kinase inhibitor experts who have held leadership positions at four of the top global oncology companies: Amgen Inc., AstraZeneca plc, Novartis AG, and Pfizer Inc. Our team includes one of the inventors of Inlyta (axitinib), Lorbrena (lorlatinib) and Xalkori (crizotinib), the research co-lead for LXH254 and the translational co-lead for PLX8394. Our team members have also been involved with the development of Mektovi (binimetinib), Cabometyx (cabozantinib), Tabrecta (capmatinib), Zykadia (ceritinib), Braftovi (encorafenib), Rozlytrek (entrectinib) and EGF816. |
• | Functional experts across domains such as biomarkers and toxicology who have developed their expertise at companies including AstraZeneca plc, Exelixis, Inc., GRAIL, Inc., Puma Biotechnology, Inc. and WuXi NextCODE Genomics USA, Inc. (now known as Genuity Science, Inc.). |
• | Senior leaders with a track record of success who have built and operated drug development businesses from research and development to commercial-stage operations at companies including Audentes Therapeutics, Inc., Biogen Inc., Novartis AG, PaxVax, Inc. (now part of Emergent BioSolutions Inc.), and Quanticel Pharmaceuticals, Inc. |
• | Keith Flaherty, M.D., Director of Clinical Research at the Massachusetts General Hospital Cancer Center, and Professor of Medicine at Harvard Medical School. Dr. Flaherty was a co-founder of Loxo Oncology, Inc. and is on our board of directors. |
• | Ryan Corcoran, M.D., Ph.D., Director of the Gastrointestinal Cancer Center Program, Scientific Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School. |
• | Ezra Cohen, M.D., Co-Director of the San Diego Center for Precision Immunotherapy, Assistant Director for Translational Science, and head of the Solid Tumor Therapeutics research program at Moores Cancer Center at UCSD. |
• | Luis Alberto Diaz, Jr., M.D., Head of the Division of Solid Tumor Oncology, Grayer Family Chair, at Memorial Sloan Kettering Cancer Center. |
• | Andrew Lowy, M.D., Professor of Surgery, Chief of the Division of Surgical Oncology and Clinical Director for Cancer Surgery at Moores Cancer Center at UCSD. |
• | John Iafrate, M.D., Professor of Pathology at Harvard Medical School and Director of the Center for Integrated Diagnostics at the Massachusetts General Hospital Cancer Center. |
• | those with cancers that harbor known oncogenic drivers with no currently available targeted therapies; |
• | those with genomically well-characterized tumors that have intrinsic resistance to currently available treatments (non-responders); and |
• | those whose tumors have acquired resistance over the course of therapy to currently available treatments. |
• | define emerging patient populations; |
• | demonstrate selective in vitro and in vivo activity and define dose-exposure pharmacodynamic (PD) relationships in clinically relevant models; |
• | test prioritized compounds against specific mutations and fusions; |
• | investigate mechanism of action—the specific biochemical interaction through which a drug substance produces its pharmacological effect—to support the refinement of strategies for patient selection and patient stratification for both monotherapy and rationale combinations; and |
• | develop biomarker-based development strategies that will drive patient selection in our clinical programs. |
• | Class I: BRAF mutations where BRAF monomers activate the MAPK signaling pathway. |
• | Class II: BRAF mutations that generate BRAF homodimers, where two BRAF molecules combine, which are RAS-independent and activate the MAPK pathway. These are frequently the result of point mutations, indels or gene fusions, in which the kinase domain of BRAF is aberrantly joined to a partner gene. |
• | Class III: BRAF mutations with minimal kinase activity that induce BRAF’s dimerization to other RAF kinase family members (e.g., ARAF or CRAF), creating a RAF heterodimer with enhanced affinity to activated RAS and increased enzymatic activity and downstream signaling. |
• | inhibit RAF across both sides of the RAF dimer, which enables populations beyond Class I mutations to be targeted; |
• | enable large drug exposures in vivo for BRAF mutant target coverage while avoiding pathway rebound; and |
• | target Class II and Class III BRAF mutations, which has been enabled by technological advances and increased access to genomic profiling. |
• | Part A: Dose Escalation: Patients with advanced or metastatic solid tumors bearing any BRAF Class I, Class II or Class III mutation (including NSCLC, melanoma and other solid tumors) will be sequentially enrolled in cohorts of 1 to 3 patients each to receive oral KIN002787 monotherapy. |
• | Part B: Dose Expansion: Patients with advanced or metastatic solid tumors bearing either a Class II or Class III BRAF mutation (including NSCLC, melanoma and other solid tumors, but excluding Class I mutation-driven cancers) will be sequentially enrolled in one of a number of cohorts defined by disease or biomarker of up to 20 to 30 patients per cohort to receive oral KIN002787 as a single anti-cancer agent. |
• | a Phase 1 trial design that incorporates both sequential dose escalation and dose expansion phases; |
• | enrollment of patient populations with molecularly-defined FGFR2- or FGFR3-alteration driven cancers; and |
• | expansion into a number of cohorts defined by disease or biomarker. |
• | significantly augment the clinical benefits of PARP inhibitors, chemotherapeutic agents and ICIs in the subset of these cancer patients who are currently eligible to be treated with these drugs; and |
• | therapeutically sensitize cancers from expanded populations of OC, mCRPC and TNBC patients who are not currently eligible to receive PARP inhibitors or ICIs, and who yet may gain substantial benefit from combination therapy with either PARP inhibitors, conventional chemotherapies, or an ICI agent. |
• | approximately 62% of all BRAF-mutated lung cancers; |
• | approximately 21% of all BRAF-mutated melanomas; and |
• | approximately 18% of all BRAF-mutated CRCs. |
• | define emerging patient populations; |
• | demonstrate selective in vitro and in vivo activity and define dose-exposure pharmacodynamic relationships in clinically relevant models; |
• | test prioritized compounds against specific mutations and fusions; |
• | investigate mechanism of action—the specific biochemical interaction through which a drug substance produces its pharmacological effect—to support the refinement of strategies for patient selection and patient stratification for both monotherapy and rationale combinations; and |
• | develop biomarker-based development strategies that will drive patient selection in our clinical programs. |
• | Keith Flaherty, M.D., Director of Clinical Research at the Massachusetts General Hospital Cancer Center, and Professor of Medicine at Harvard Medical School. Dr. Flaherty was a co-founder of Loxo Oncology, Inc. and is on our board of directors. |
• | Ryan Corcoran, M.D., Ph.D., Director of the Gastrointestinal Cancer Center Program, Scientific Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School. |
• | Ezra Cohen, M.D., Co-Director of the San Diego Center for Precision Immunotherapy, Assistant Director for Translational Science, and head of the Solid Tumor Therapeutics research program at Moores Cancer Center at UCSD. |
• | Luis Alberto Diaz, Jr., M.D., Head of the Division of Solid Tumor Oncology, Grayer Family Chair, at Memorial Sloan Kettering Cancer Center. |
• | Andrew Lowy, M.D., Professor of Surgery, Chief of the Division of Surgical Oncology and Clinical Director for Cancer Surgery at Moores Cancer Center at UCSD. |
• | John Iafrate, M.D., Professor of Pathology at Harvard Medical School and Director of the Center for Integrated Diagnostics at the Massachusetts General Hospital Cancer Center. |
• | completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP; |
• | submission to the FDA of an IND, which must become effective before human clinical trials may begin; |
• | approval by an independent IRB, or ethics committee at each clinical trial site before each trial may be initiated; |
• | performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice (GCP) requirements and other clinical trial-related regulations to establish substantial evidence of the safety and efficacy of the investigational product for each proposed indication; |
• | submission to the FDA of an NDA after completion of all pivotal trials; |
• | determination by the FDA within 60 days of its receipt of an NDA to accept the filing for substantive review; |
• | satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements assuring that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |
• | potential FDA audit of the preclinical study and/or clinical trial sites that generated the data in support of the NDA filing; |
• | FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States; and |
• | compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (REMS), and the potential requirement to conduct post-approval studies. |
• | Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, tolerability and safety of the drug. |
• | Phase 2 clinical trials involve studies in disease-affected patients to determine the dose and dosing schedule required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. |
• | Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use and its safety in use, and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing. |
• | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market, or product recalls; |
• | fines, warning letters, or holds on post-approval clinical studies; |
• | refusal of the FDA to approve pending applications or supplements to approved applications; |
• | suspension or revocation of product approvals; |
• | product seizure or detention; |
• | refusal to permit the import or export of products; and |
• | injunctions or the imposition of civil or criminal penalties. |
• | The federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. Moreover, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act. |
• | The federal false claims, including the civil False Claims Act that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government, and/or impose exclusions from federal health care programs and/or penalties for parties who engage in such prohibited conduct. |
• | The Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations also impose obligations on covered entities such as health |
• | The federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to Centers for Medicare & Medicaid Services (CMS) information regarding certain payments and other transfers of value to physicians, as defined by such law, and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members; additionally, President Trump signed into law in 2018 the “Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act” which, under the provision entitled “Fighting the Opioid Epidemic with Sunshine,” in part, extends the reporting and transparency requirements for physicians under the Physician Payments Sunshine Act to physician assistants, nurse practitioners, and other mid-level practitioners, with reporting requirements going into effect in 2022 for payments made in 2021. |
• | Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and require the registration of their sales representatives, state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
• | The Community MA is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP), of the EMA, and is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU. |
• | National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member States through the Mutual Recognition Procedure. If the product has not received a National MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as the Reference Member State (RMS). The competent authority of the RMS prepares a draft assessment report, a draft summary of the product characteristics (SOPC), and a draft of the labeling and package leaflet, which are sent to the other Member States (referred to as the Member States Concerned) for their approval. If the Member States Concerned raise no objections, based on a potential serious risk to public health, to the assessment, SOPC, labeling or packaging proposed by the RMS, the product is subsequently granted a national MA in all the Member States (i.e., in the RMS and the Member States Concerned). |
Name | | | Age | | | Position |
Executive Officers: | | | | | ||
Nima Farzan | | | 44 | | | President, Chief Executive Officer and Director |
Mark Meltz | | | 47 | | | Chief Operating Officer, General Counsel, Treasurer and Secretary |
Eric Murphy, Ph.D. | | | 45 | | | Chief Scientific Officer |
Richard Williams, MBBS, Ph.D. | | | 52 | | | Chief Medical Officer |
Non-Employee Directors: | | | | | ||
Dean Mitchell(2)(3) | | | 64 | | | Chair and Director |
Melissa Epperly(1) | | | 43 | | | Director |
Keith Flaherty, M.D.(3) | | | 50 | | | Director |
Carl Gordon, Ph.D.(1)(2) | | | 55 | | | Director |
Stephen Kaldor, Ph.D. | | | 58 | | | Director |
Michael Rome, Ph.D.(1)(3) | | | 36 | | | Director |
Laurie Smaldone Alsup, M.D.(3) | | | 66 | | | Director |
Jim Tananbaum, M.D.(2) | | | 57 | | | Director |
(1) | Member of the audit committee |
(2) | Member of the compensation committee |
(3) | Member of the corporate governance and nominating committee |
• | the Class I directors will be Carl Gordon, Ph.D., Stephen Kaldor, Ph.D., and Jim Tananbaum, M.D., and their terms will expire at the annual meeting of stockholders to be held in 2021; |
• | the Class II directors will be Laurie Smaldone Alsup, M.D., Melissa Epperly, and Michael Rome, Ph.D., and their terms will expire at the annual meeting of stockholders to be held in 2022; and |
• | the Class III directors will be Nima Farzan, Keith Flaherty, M.D., and Dean Mitchell, and their terms will expire at the annual meeting of stockholders to be held in 2023. |
• | select and hire the independent registered public accounting firm to audit our financial statements; |
• | help to ensure the independence and performance of the independent registered public accounting firm; |
• | approve audit and non-audit services and fees; |
• | review financial statements and discuss with management and the independent registered public accounting firm our annual audited and quarterly financial statements, the results of the independent audit and the quarterly reviews and the reports and certifications regarding internal controls over financial reporting and disclosure controls; |
• | prepare the audit committee report that the SEC requires to be included in our annual proxy statement; |
• | review reports and communications from the independent registered public accounting firm; |
• | review the adequacy and effectiveness of our internal controls and disclosure controls and procedure; |
• | review our policies on risk assessment and risk management; |
• | review and monitor conflicts of interest situations, and approve or prohibit any involvement in matters that may involve a conflict of interest or taking of a corporate opportunity; |
• | review related party transactions; and |
• | establish and oversee procedures for the receipt, retention and treatment of accounting related complaints and the confidential submission by our employees of concerns regarding questionable accounting or auditing matters. |
• | oversee our overall compensation philosophy and compensation policies, plans and benefit programs; |
• | review and approve compensation for our executive officers and directors; |
• | prepare the compensation committee report that the SEC will require to be included in our annual proxy statement; and |
• | administer our equity compensation plans. |
• | identify, evaluate and make recommendations to our board of directors regarding nominees for election to our board of directors and its committees; |
• | consider and make recommendations to our board of directors regarding the composition of our board of directors and its committees; |
• | review developments in corporate governance practices; |
• | evaluate the adequacy of our corporate governance practices and reporting; and |
• | evaluate the performance of our board of directors and of individual directors. |
Name | | | Fees Earned or Paid in Cash ($) | | | Option Awards ($) | | | Total ($) |
Melissa Epperly | | | — | | | — | | | — |
Keith Flaherty, M.D. | | | 41,250 | | | — | | | 41,250 |
Carl Gordon, Ph.D. | | | — | | | — | | | — |
Dean Mitchell | | | — | | | — | | | — |
Michael Rome, Ph.D. | | | — | | | — | | | — |
Laurie Smaldone Alsup, M.D. | | | — | | | — | | | — |
Jim Tananbaum, M.D. | | | — | | | — | | | — |
Board Chair: | | | $30,000 |
Audit Committee Chair: | | | $15,000 |
Audit Committee Member: | | | $7,500 |
Compensation Committee Chair: | | | $10,000 |
Compensation Committee Member: | | | $5,000 |
Nominating and Corporate Governance Committee Chair: | | | $8,000 |
Nominating and Corporate Governance Committee Member: | | | $4,000 |
• | Stephen Kaldor, Ph.D., a current member of our board of directors and former President and Chief Executive Officer; and |
• | Eric Murphy, Ph.D., our Chief Scientific Officer. |
Name and Principal Position | | | Year | | | Salary ($) | | | Bonus ($) | | | Option Awards ($) | | | All Other Compensation ($) | | | Total ($) |
Stephen Kaldor, Ph.D. Director and former President and Chief Executive Officer | | | 2019 | | | 336,156 | | | 67,275 | | | — | | | 1,481 | | | 404,912 |
Eric Murphy, Ph.D. Chief Scientific Officer | | | 2019 | | | 336,156 | | | 67,275 | | | — | | | 344 | | | 403,776 |
| | | | Option Awards | | | Stock Awards | ||||||||||||||
Name | | | Grant Date(1) | | | Number of Securities Underlying Unexercised Options Exercisable (#) | | | Number of Securities Underlying Unexercised Options Unexercisable (#) | | | Option Exercise Price ($)(2) | | | Option Expiration Date | | | Number of Shares of Stock that Have Not Vested (#) | | | Market Value of Shares of Stock that Have Not Vested ($)(3) |
Stephen Kaldor, Ph.D. | | | — | | | — | | | — | | | — | | | — | | | — | | | — |
Eric Murphy, Ph.D. | | | — | | | — | | | — | | | — | | | — | | | — | | | — |
• | a lump-sum payment equal to 9 months (or 12 months in the case of Mr. Farzan) of the executive officer’s annual base salary as in effect immediately prior to such termination (or if such termination is due to a resignation for good reason based on a material reduction in base salary, then as in effect immediately prior to the reduction); |
• | payment of premiums for coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (COBRA), for the executive officer and his eligible dependents, if any, for up to 9 months (or 12 months in the case of Mr. Farzan); |
• | in the case of Messrs. Farzan and Meltz and Dr. Williams, vesting acceleration of any outstanding company equity award that would have otherwise vested had the executive officer remained employed for another 12 months (in the case of Mr. Farzan) or 9 months (in the case of Mr. Meltz and Dr. Williams); and |
• | in the case of Dr. Murphy, a lump sum payment equal to the pro-rated portion of Dr. Murphy’s target bonus for the year of termination based on the number of days in such year for which Dr. Murphy is employed by, or provided service to, us. |
• | a lump-sum payment equal to 12 months (or 18 months in the case of Mr. Farzan) of the executive officer’s annual base salary as in effect immediately prior to such termination (or if such termination is due to a resignation for good reason based on a material reduction in base salary, then as in effect immediately prior to the reduction) or if greater, at the level in effect immediately prior to the change in control based on the number of days in such year for which Dr. Murphy is employed by, or provided service to, us; |
• | a lump-sum payment equal to the sum of (x) 100% (or 150% in the case of Mr. Farzan) of the executive officer’s target annual bonus as in effect for the fiscal year in which such termination occurs or if greater, at the level in effect, immediately prior to the change in control, plus (y) a pro-rated portion of the executive officer’s target bonus for the year in which the change of control occurs; |
• | payment of premiums for coverage under COBRA for the executive officer and the executive officer’s eligible dependents, if any, for up to 12 months (or 18 months in the case of Mr. Farzan); and |
• | 100% accelerated vesting and exercisability of all company equity awards with service-based vesting (but that are not subject to performance-based vesting) that are outstanding and unvested as of the date of the qualifying termination. |
• | 4,348,000 shares; |
• | five percent (5%) of the outstanding shares of our common stock as of the last day of the immediately preceding fiscal year; or |
• | such other amount as our board of directors may determine. |
• | 870,000 shares; |
• | one percent (1%) of the outstanding shares of our common stock as of the last day of the immediately preceding fiscal year; or |
• | such other amount as the administrator may determine. |
• | immediately after the grant would own capital stock and/or hold outstanding options to purchase such stock possessing 5% or more of the total combined voting power or value of all classes of capital stock of ours or of any parent or subsidiary of ours; or |
• | holds rights to purchase shares of our common stock under all employee stock purchase plans of ours or any parent or subsidiary of ours that accrue at a rate that exceeds $25,000 worth of shares of our common stock for each calendar year in which such rights are outstanding at any time. |
• | any breach of the director’s duty of loyalty to us or to our stockholders; |
• | acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; |
• | unlawful payment of dividends or unlawful stock repurchases or redemptions; and |
• | any transaction from which the director derived an improper personal benefit. |
• | we have been or are to be a participant; |
• | the amount involved exceeded or exceeds $120,000; and |
• | any of our directors, executive officers or holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person sharing the household with, any of these individuals or entities, had or will have a direct or indirect material interest. |
Investor | | | Shares of Series A Convertible Preferred Stock | | | Total Series A Convertible Preferred Stock Purchase Price |
Eshelman Ventures, LLC(1) | | | 1,586,295 | | | $3,916,664 |
Foresite Capital Fund IV, L.P.(2) | | | 5,568,917 | | | $13,749,997 |
(1) | Eshelman Ventures, LLC was a holder of more than 5% of our outstanding capital stock prior to its sale in July 2020 to other of our existing stockholders of all shares of our capital stock held by Eshelman Ventures, LLC. Fred Eshelman is the founder and principal of Eshelman Ventures, LLC and had sole voting and dispositive power with respect to such shares prior to such sale. |
Investor | | | Shares of Series A Convertible Preferred Stock |
Eshelman Ventures, LLC(1) | | | 151,879 |
Foresite Capital Fund IV, L.P.(2) | | | 455,638 |
(1) | Eshelman Ventures, LLC was a holder of more than 5% of our outstanding capital stock prior to its sale in July 2020 to other of our existing stockholders of all shares of our capital stock held by Eshelman Ventures, LLC. Fred Eshelman is the founder and principal of Eshelman Ventures, LLC and had sole voting and dispositive power with respect to such shares prior to such sale. |
(2) | Michael Rome, Ph.D., is a member of our board of directors and a Managing Director of Foresite Capital. Jim Tananbaum, M.D., is a member of our board of directors and CEO and Managing Director of Foresite Capital. Additional details regarding this stockholder and its equity holdings, including the identities of the natural persons who exercise voting and dispositive power with respect to its shares, are provided in this prospectus under the section titled “Principal Stockholders.” |
Investor | | | Shares of Series B Convertible Preferred Stock | | | Total Series B Convertible Preferred Stock Purchase Price |
Eshelman Ventures, LLC(1) | | | 325,676 | | | $2,499,997 |
Foresite Capital Fund IV, L.P.(2)(3) | | | 2,605,419 | | | $19,999,998 |
Nextech V Oncology S.C.S., SICAV-SIF(3) | | | 2,214,606 | | | $17,000,000 |
OrbiMed Private Investments VII, LP(3)(4) | | | 2,605,419 | | | $19,999,998 |
Vida Ventures, LLC(3) | | | 1,954,064 | | | $14,999,999 |
(1) | Eshelman Ventures, LLC was a holder of more than 5% of our outstanding capital stock prior to its sale in July 2020 to other of our existing stockholders of all shares of our capital stock held by Eshelman Ventures, LLC. Fred Eshelman is the founder and principal of Eshelman Ventures, LLC and had sole voting and dispositive power with respect to such shares prior to such sale. |
(2) | Michael Rome, Ph.D., is a member of our board of directors and a Managing Director of Foresite Capital. Jim Tananbaum, M.D., is a member of our board of directors and CEO and Managing Director of Foresite Capital. |
(3) | Additional details regarding this stockholder and its equity holdings, including the identities of the natural persons who exercise voting and dispositive power with respect to its shares, are provided in this prospectus under the section titled “Principal Stockholders.” |
(4) | Carl Gordon, Ph.D., a member of our board of directors, is a Founding Partner and Co-Head of Global Private Equity at OrbiMed Advisors, LLC. |
Investor | | | Shares of Series C Convertible Preferred Stock | | | Total Series C Convertible Preferred Stock Purchase Price |
Entities affiliated with Foresite Capital(1)(2) | | | 350,726 | | | $4,149,719 |
Nextech V Oncology S.C.S., SICAV-SIF(2) | | | 121,511 | | | $1,437,696 |
Entities affiliated with OrbiMed Advisors(2)(3) | | | 142,953 | | | $1,691,394 |
Entities affiliated with RA Capital Management, L.P.(2) | | | 2,958,143 | | | $34,999,992 |
Vida Ventures, LLC(2) | | | 107,211 | | | $1,268,500 |
(1) | Michael Rome, Ph.D., is a member of our board of directors and a Managing Director of Foresite Capital. Jim Tananbaum, M.D., is a member of our board of directors and CEO and Managing Director of Foresite Capital. |
(2) | Additional details regarding this stockholder and its equity holdings, including the identities of the natural persons who exercise voting and dispositive power with respect to its shares, are provided in this prospectus under the section titled “Principal Stockholders.” |
(3) | Carl Gordon, Ph.D., a member of our board of directors, is a Founding Partner and Co-Head of Global Private Equity at OrbiMed Advisors, LLC. |
• | each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our common stock; |
• | each of the named executive officers; |
• | each of our directors; and |
• | all of our current executive officers and directors as a group. |
| | Shares Beneficially Owned Prior to this Offering | | | Shares Beneficially Owned After this Offering | |||||||
Name of Beneficial Owner | | | Shares | | | Percentage | | | Shares | | | Percentage |
5% and Greater Stockholders: | | | | | | | | | ||||
Entities affiliated with Foresite Capital(1) | | | 9,838,311 | | | 33.15% | | | 9,838,311 | | | 23.89% |
Entities affiliated with OrbiMed(2) | | | 3,097,929 | | | 10.44% | | | 3,097,929 | | | 7.52% |
Entities affiliated with RA Capital Management(3) | | | 2,968,052 | | | 10.00% | | | 2,968,052 | | | 7.21% |
Nextech V Oncology S.C.S., SICAV-SIF(4) | | | 2,633,243 | | | 8.87% | | | 2,633,243 | | | 6.40% |
Vida Ventures, LLC(5) | | | 2,323,433 | | | 7.83% | | | 2,323,433 | | | 5.64% |
Stephen Kaldor, Ph.D.(6) | | | 1,822,414 | | | 6.10% | | | 1,822,414 | | | 4.40% |
Eric Murphy, Ph.D.(7) | | | 1,615,826 | | | 5.44% | | | 1,615,826 | | | 3.92% |
| | | | | | | | |||||
Named Executive Officers and Directors: | | | | | | | | | ||||
Nima Farzan(8) | | | 1,281,642 | | | 4.14% | | | 1,281,642 | | | 3.02% |
Eric Murphy, Ph.D.(7) | | | 1,615,826 | | | 5.44% | | | 1,615,826 | | | 3.92% |
Dean Mitchell(9) | | | 25,313 | | | * | | | 25,313 | | | * |
Melissa Epperly(10) | | | 5,062 | | | * | | | 5,062 | | | * |
Keith Flaherty, M.D.(11) | | | 73,290 | | | * | | | 73,290 | | | * |
Carl Gordon, Ph.D.(12) | | | 3,097,929 | | | 10.44% | | | 3,097,929 | | | 7.52% |
Stephen Kaldor, Ph.D.(6) | | | 1,822,414 | | | 6.10% | | | 1,822,414 | | | 4.40% |
Michael Rome, Ph.D.(13) | | | — | | | — | | | — | | | — |
Laurie Smaldone Alsup, M.D.(14) | | | 12,656 | | | * | | | 12,656 | | | * |
Jim Tananbaum, M.D.(15) | | | 9,838,311 | | | 33.15% | | | 9,838,311 | | | 23.89% |
All current executive officers and directors as a group (12 persons)(16) | | | 18,156,951 | | | 57.46% | | | 18,156,951 | | | 42.13% |
* | Represents beneficial ownership of less than 1% of the outstanding shares of our common stock. |
(1) | Consists of (i) 9,171,643 shares of capital stock held by Foresite Capital Fund IV, LP (Fund IV), (ii) 500,001 shares of capital stock held by Foresite Capital Fund V, LP (Fund V), and (iii) 166,667 shares of capital stock held by Foresite Capital Opportunity Fund V, L.P. (Opportunity Fund V), each on an as-converted to common stock basis. Jim Tananbaum, M.D., is a member of our board of directors and CEO and Managing Director of Foresite Capital. Foresite Capital Management IV, LLC (FCM IV) is the general partner of Fund IV and may be deemed to have sole voting and dispositive power over the shares held by Fund IV; Foresite Capital Management V, LLC (FCM V) is the general partner of Fund V and may be deemed to have sole voting and dispositive power over the shares held by Fund V; and Foresite Capital Opportunity Management V, LLC (FCOM V) is the general partner of Opportunity Fund V and may be deemed to have sole voting and dispositive power over the shares held by Opportunity Fund V. Dr. Tananbaum, in his capacity as managing member of FCM IV, FCM V, and FCOM V, may be deemed to have sole voting and dispositive power over all of such shares. Dr. Tananbaum disclaims beneficial ownership of the shares held by Fund IV, Fund V, and Opportunity Fund V except to the extent of his pecuniary interest therein, if any. The address of Dr. Tananbaum and each of the entities listed above is 600 Montgomery Street, Suite 4500, San Francisco, CA 94111. |
(2) | Consists of (i) 3,013,330 shares of capital stock held by OrbiMed Private Investments VII, LP (OPI VII) and (ii) 84,599 shares of capital stock held by OrbiMed Genesis Master Fund, L.P. (Genesis), each on an as-converted to common stock basis. OrbiMed Capital GP VII LLC (OrbiMed GP VII) is the general partner of OPI VII and OrbiMed Advisors LLC (OrbiMed Advisors) is the managing member of OrbiMed GP VII. By virtue of such relationships, OrbiMed GP VII and OrbiMed Advisors may be deemed to have voting power and investment power over the securities held by OPI VII and as a result, may be deemed to have beneficial ownership over such securities. OrbiMed Genesis GP LLC (Genesis GP) is the general partner of Genesis. OrbiMed is the managing member of Genesis GP. By virtue of such relationships, Genesis GP and OrbiMed Advisors may be deemed to have voting and investment power over the securities held by Genesis and as a result, may be deemed to have beneficial ownership over such securities. OrbiMed Advisors exercises voting and investment power through a management committee comprised of Carl L. Gordon, Ph.D., Sven H. Borho, and Jonathan T. Silverstein, each of whom disclaims beneficial ownership of the shares held by OPI VII and Genesis. The address of each of the individuals and entities listed above is 601 Lexington Avenue, 54th Floor, New York, NY 10022. |
(3) | Consists of (i) 2,006,199 shares of capital stock held by RA Capital Healthcare Fund, L.P. (RA Capital Healthcare Fund), (ii) 742,013 shares of capital stock held by RA Capital Nexus Fund, L.P. (RA Capital Nexus Fund and, together with RA Capital Healthcare Fund, the Funds) and (iii) 219,840 shares of capital stock held by a separately managed account (the Account), each on an as-converted to common stock basis. RA Capital Management, L.P. (Adviser) is the investment manager for the Funds and the Account. The general partner of the Adviser is RA Capital Management GP, LLC (GP Adviser), of which Dr. Peter Kolchinsky and Mr. Rajeev Shah are the managing members. The Adviser, the Adviser GP, Dr. Kolchinsky, and Mr. Shah may be deemed indirect beneficial owners of the shares held by the Funds and the Account. The Advisor, the Advisor GP, Dr. Kolchinsky, and Mr. Shah disclaim beneficial ownership of all applicable shares except to the extent of their actual pecuniary interest therein. The address of each of the individuals and entities listed above is 200 Berkeley Street, 18th Floor, Boston, MA 02116. |
(4) | Consists of 2,633,243 shares of capital stock held by Nextech V Oncology S.C.S. SICAV-SIF (Nextech V), on an as-converted to common stock basis. Nextech Invest Ltd. is a managing member of Nextech V. Nextech V GP S.A.R.L (Nextech V GP) is the general partner of Nextech V. Philippe Detournay, Dalia Bleyer and Thomas Lips are managers of Nextech V GP. Each of Mr. Detournay, Ms. Bleyer, and Mr. Lips exercise investment and voting control over the shares held by Nextech V. Each of Mr. Detournay, Ms. Bleyer, and Mr. Lips disclaim beneficial ownership over the shares held by Nextech V, except to the extent of their respective pecuniary interest therein, if any. The address of each of the individuals and entities listed above is 8, Rue Lou Hemmer, L-1748 Senningerberg, Grand Duchy of Luxembourg. |
(5) | Consists of 2,323,433 shares of capital stock held by Vida Ventures, LLC (Vida), on an as-converted to common stock basis. VV Manager, LLC (VV Manager) is a managing member of Vida. Arjun Goyal, Fred Cohen, Arie Belldegrun, Leonard Potter and Stefan Vitorovic are also managing members of VV Manager. Arjun Goyal, Fred Cohen, Arie Belldegrun, Leonard Potter and Stefan Vitorovic exercise investment and voting control over the shares held by Vida. Each of Arjun Goyal, Fred Cohen, Arie Belldegrun, Leonard Potter and Stefan Vitorovic disclaim beneficial ownership of the shares held by Vida, except to the extent of their pecuniary interest therein, if any. The address of each of the individuals and entities listed above is 40 Broad Street, Suite 201, Boston, MA 02109. |
(6) | Consists of (i) 1,615,826 shares of capital stock held by Dr. Kaldor and (ii) 206,588 shares subject to options held by Dr. Kaldor exercisable within 60 days of November 21, 2020. |
(7) | Represents shares of capital stock held by Dr. Murphy. |
(8) | Represents shares subject to options held by Mr. Farzan, all of which are exercisable and none of which are vested within 60 days of October 31, 2020. |
(9) | Represents shares subject to options held by Mr. Mitchell exercisable within 60 days of November 21, 2020. |
(10) | Represents shares subject to options held by Ms. Epperly exercisable within 60 days of November 21, 2020. |
(11) | Consists of (i) 66,377 shares of capital stock held by Dr. Flaherty and (ii) 6,913 shares subject to options held by Dr. Flaherty exercisable within 60 days of November 21, 2020. |
(12) | Consists of the shares described in footnote (3) above. Dr. Gordon disclaims beneficial ownership of such shares except to the extent of his pecuniary interest therein, if any. |
(13) | Dr. Rome has no voting or investment control over the shares held by entities affiliated with Foresite Capital that are included in footnote (1) above. |
(14) | Represents shares subject to options held by Dr. Smaldone Alsup exercisable within 60 days of November 21, 2020. |
(15) | Consists of the shares described in footnote (1) above. Dr. Tananbaum disclaims beneficial ownership of such shares except to the extent of his pecuniary interest therein, if any. |
(16) | Consists of (i) 16,234,269 shares beneficially owned by our current executive officers and directors as of November 21, 2020 and (ii) 1,922,682 shares subject to options exercisable within 60 days of November 21, 2020, of which 256,532 are vested as of such date. |
• | no shares will be eligible for sale on the date of this prospectus; and |
• | 29,527,219 shares will be eligible for sale upon expiration of the lock-up agreements and market stand-off provisions described below, following the date that is 180 days after the date of this prospectus. |
• | 1% of the number of shares of our capital stock then outstanding, which will equal 410,272 shares immediately after the completion of this offering, assuming no exercise by the underwriters of their option to purchase additional shares; or |
• | the average weekly trading volume of our common stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale. |
• | banks, insurance companies, regulated investment companies, real estate investment trusts or other financial institutions; |
• | tax-exempt organizations; |
• | pension plans and tax-qualified retirement plans; |
• | controlled foreign corporations, passive foreign investment companies and corporations that accumulate earnings to avoid U.S. federal income tax; |
• | brokers or dealers in securities or currencies; |
• | traders in securities that elect to use a mark-to-market method of accounting for their securities holdings; |
• | persons that own, or are deemed to own, more than 5% of our capital stock (except to the extent specifically set forth below); |
• | certain former citizens or long-term residents of the United States; |
• | partnerships (or entities or arrangements classified as such for U.S. federal income tax purposes), other pass-through entities, and investors therein; |
• | persons who hold our common stock as a position in a hedging transaction, “straddle,” “conversion transaction” or other risk reduction transaction; |
• | persons who hold or receive our common stock pursuant to the exercise of any option or otherwise as compensation; |
• | persons subject to special tax accounting rules as a result of any item of gross income with respect to our common stock being taken into account in an “applicable financial statement” as defined in Section 451(b) of the Code; |
• | persons who do not hold our common stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment); or |
• | persons deemed to sell our common stock under the constructive sale provisions of the Code. |
• | an individual who is a citizen or resident of the United States; |
• | a corporation or other entity taxable as a corporation created or organized in the United States or under the laws of the United States or any political subdivision thereof, or otherwise treated as such for U.S. federal income tax purposes; |
• | an estate whose income is subject to U.S. federal income tax regardless of its source; or |
• | a trust (i) whose administration is subject to the primary supervision of a U.S. court and that has one or more U.S. persons who have the authority to control all substantial decisions of the trust or (ii) that has made a valid election under applicable Treasury Regulations to be treated as a U.S. person. |
• | the gain is effectively connected with your conduct of a U.S. trade or business (and, if an applicable income tax treaty so provides, the gain is attributable to a permanent establishment or fixed base maintained by you in the United States); |
• | you are an individual who is present in the United States for a period or periods aggregating 183 days or more during the calendar year in which the sale or disposition occurs and certain other conditions are met; or |
• | our common stock constitutes a United States real property interest by reason of our status as a “United States real property holding corporation” (USRPHC), for U.S. federal income tax purposes at any time within the shorter of the five-year period preceding your disposition of, or your holding period for, our common stock, unless our common stock is regularly traded on an established securities market and you hold no more than 5% of our outstanding common stock, directly, indirectly and constructively, at all times, during the shorter of the five-year period ending on the date of the taxable disposition or your holding period for our common stock. |
Underwriters | | | Number of Shares |
Goldman Sachs & Co. LLC | | | |
SVB Leerink LLC | | | |
Piper Sandler & Co. | | | |
Wedbush Securities Inc. | | | |
Total | | | 11,500,000 |
| | No Exercise | | | Full Exercise | |
Per Share | | | $ | | | $ |
Total | | | $ | | | $ |
(i) | to any legal entity which is a qualified investor as defined under the Prospectus Regulation; |
(ii) | to fewer than 150 natural or legal persons (other than qualified investors as defined under the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or |
(iii) | in any other circumstances falling within Article 1(4) of the Prospectus Regulation, |
(i) | it has only communicated or caused to be communicated and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and Markets Act 2000 (as amended, the FSMA)) received by it in connection with the issue or sale of the shares in circumstances in which Section 21(1) of the FSMA does not apply to the company; and |
(ii) | it has complied and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to the shares in, from or otherwise involving the United Kingdom. |
| | Page | |
Audited Financial Statements: | | | |
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Unaudited Interim Condensed Financial Statements: | | | |
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| | December 31, | ||||
| | 2018 | | | 2019 | |
Assets | | | | | ||
Current assets: | | | | | ||
Cash and cash equivalents | | | $ 6,999 | | | $76,453 |
Related party receivables, net (See Note 8) | | | 1,078 | | | 973 |
Prepaid expenses | | | — | | | 25 |
Total current assets | | | 8,077 | | | 77,451 |
Property and equipment | | | — | | | 154 |
Total assets | | | $8,077 | | | $77,605 |
| | | | |||
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit) | | | | | ||
Current liabilities: | | | | | ||
Accounts payable | | | $442 | | | $956 |
Accrued expenses | | | 25 | | | 989 |
Total current liabilities | | | 467 | | | 1,945 |
Commitments and contingencies (See Note 10) | | | | | ||
Convertible preferred stock: | | | | | ||
Series A convertible preferred stock, $0.0001 par value; 7,762,733 shares authorized at December 31, 2019; 7,762,727 shares issued and outstanding at December 31, 2019; aggregate liquidation preference of $19,167 at December 31, 2019 | | | — | | | 18,942 |
Series B convertible preferred stock, $0.0001 par value; 0 and 9,705,185 shares authorized, 0 and 9,705,182 shares issued and outstanding at December 31, 2018 and 2019, respectively; aggregate liquidation preference of $74,500 at December 31, 2019 | | | — | | | 74,204 |
Stockholders’ equity (deficit): | | | | | ||
Series A convertible preferred stock, $0.0001 par value; 5,670,174 shares authorized at December 31, 2018; 3,715,445 shares issued and outstanding at December 31, 2018 | | | — | | | — |
Common stock, $0.0001 par value; 16,200,497 and 26,914,696 shares authorized at December 31, 2018 and 2019, respectively; 3,659,283 and 3,665,020 shares issued and outstanding at December 31, 2018 and 2019, respectively | | | — | | | — |
Additional paid-in capital | | | 15,240 | | | 82 |
Accumulated deficit | | | (7,630) | | | (17,568) |
Total stockholders’ equity (deficit) | | | 7,610 | | | (17,486) |
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | | | $8,077 | | | $77,605 |
| | For the Period January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
Operating expenses: | | | | | ||
Research and development (includes related party amounts of $1,454 and $2,301, respectively) | | | $5,675 | | | $8,955 |
General and administrative (includes related party amounts of $1,600 and $2,609, respectively) | | | 1,955 | | | 3,057 |
Total operating expenses | | | 7,630 | | | 12,012 |
Loss from operations | | | (7,630) | | | (12,012) |
Other income: | | | | | ||
Interest income | | | — | | | 43 |
Total other income | | | — | | | 43 |
Net loss and comprehensive loss | | | $(7,630) | | | $(11,969) |
Gain on extinguishment of Series A convertible preferred stock | | | — | | | 2,031 |
Net loss attributable to common stockholders | | | $(7,630) | | | $(9,938) |
Weighted-average shares outstanding, basic and diluted | | | 3,648,367 | | | 3,659,456 |
Net loss attributable to common stockholders per share, basic and diluted | | | $(2.09) | | | $(2.72) |
Pro forma weighted-average shares outstanding, basic and diluted (unaudited) | | | | | 10,800,776 | |
Pro forma net loss attributable to common stockholders per share, basic and diluted (unaudited) | | | | | $(0.92) |
| | Series A Convertible Preferred Stock | | | Series B Convertible Preferred Stock | | | Series A Convertible Preferred Stock | | | Common Stock | | | Additional Paid-in Capital | | | Accumulated Deficit | | | Total Stockholders’ Equity (Deficit) | |||||||||||||
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | | |||||||||
Balance at January 4, 2018 (Inception) | | | — | | | $— | | | — | | | $— | | | — | | | $— | | | — | | | $ — | | | $— | | | $— | | | $— |
Issuance of common stock | | | — | | | — | | | — | | | — | | | — | | | — | | | 3,645,108 | | | — | | | — | | | — | | | — |
Issuance of Series A convertible preferred stock, net of issuance costs of $136 | | | — | | | — | | | — | | | — | | | 3,715,445 | | | — | | | — | | | — | | | 15,198 | | | — | | | 15,198 |
Stock-based compensation expense | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 39 | | | — | | | 39 |
Exercise of stock options | | | — | | | — | | | — | | | — | | | — | | | — | | | 14,175 | | | — | | | 3 | | | — | | | 3 |
Net loss | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (7,630) | | | (7,630) |
Balance at December 31, 2018 | | | — | | | — | | | — | | | — | | | 3,715,445 | | | | | 3,659,283 | | | — | | | 15,240 | | | (7,630) | | | 7,610 | |
Issuance of Series A convertible preferred stock in merger | | | — | | | — | | | — | | | — | | | 1,617,208 | | | — | | | — | | | — | | | — | | | — | | | — |
Extinguishment of Series A convertible preferred stock | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (2,031) | | | 2,031 | | | — |
Issuance of Series A convertible preferred stock, net of issuance costs of $225 | | | — | | | — | | | — | | | — | | | 2,430,074 | | | — | | | — | | | — | | | 5,775 | | | — | | | 5,775 |
Issuance of Series B convertible preferred stock, net of issuance costs of $296 | | | — | | | — | | | 9,705,182 | | | 74,204 | | | — | | | — | | | — | | | — | | | — | | | — | | | — |
Reclassification of Series A convertible preferred stock from permanent equity to mezzanine equity | | | 7,762,727 | | | 18,942 | | | — | | | — | | | (7,762,727) | | | — | | | — | | | — | | | (18,942) | | | — | | | (18,942) |
Stock-based compensation expense | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 39 | | | — | | | 39 |
Exercise of stock options | | | — | | | — | | | — | | | — | | | — | | | — | | | 5,737 | | | — | | | 1 | | | — | | | 1 |
Net loss | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (11,969) | | | (11,969) |
Balance at December 31, 2019 | | | 7,762,727 | | | $18,942 | | | 9,705,182 | | | $74,204 | | | — | | | $ — | | | 3,665,020 | | | $— | | | $82 | | | $(17,568) | | | $(17,486) |
| | For the Period January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
Cash flows from operating activities: | | | | | ||
Net loss | | | $(7,630) | | | $(11,969) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | ||
Stock-based compensation expense | | | 39 | | | 39 |
Changes in operating assets and liabilities: | | | | | ||
Related party receivables, net | | | (1,078) | | | (49) |
Prepaid expenses | | | — | | | (25) |
Accounts payable and accrued expenses | | | 467 | | | 1,478 |
Net cash used in operating activities | | | (8,202) | | | (10,526) |
| | | | |||
Cash flows from financing activities: | | | | | ||
Proceeds from issuance of Series A convertible preferred stock, net of issuance costs | | | 15,198 | | | 5,775 |
Proceeds from issuance of Series B convertible preferred stock, net of issuance costs | | | — | | | 74,204 |
Proceeds from stock option exercises | | | 3 | | | 1 |
Net cash provided by financing activities | | | 15,201 | | | 79,980 |
Net increase in cash and cash equivalents | | | 6,999 | | | 69,454 |
Cash and cash equivalents at the beginning of the period | | | — | | | 6,999 |
Cash and cash equivalents at the end of the year | | | $6,999 | | | $76,453 |
| | | | |||
Supplemental non-cash investing activity: | | | | | ||
Property and equipment included in related party receivables, net | | | $— | | | $154 |
Organization and Basis of Presentation |
a) | Organization and Nature of Operations |
b) | Basis of Presentation |
2) | Summary of Significant Accounting Policies |
a) | Use of Estimates |
b) | Concentration of Credit Risk |
c) | Fair Value of Financials Instruments |
d) | Cash and Cash Equivalents |
e) | Property and Equipment |
| | Estimated Useful Lives (in years) | |
Furniture and fixtures | | | 3-10 |
Computers and equipment | | | 3-5 |
Computer software | | | 3-5 |
f) | Impairment of Property and Equipment |
g) | Research and Development |
h) | Commitments and Contingencies |
i) | Income Taxes |
j) | Stock-Based Compensation |
k) | Common Stock Valuation |
l) | Deferred Offering Costs |
m) | Comprehensive Loss |
n) | Net Loss Per Share |
| | For the Period January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
Numerator | | | | | ||
Net loss and comprehensive loss | | | $(7,630) | | | $(11,969) |
Gain on extinguishment of Series A convertible preferred stock | | | — | | | 2,031 |
Net loss attributable to common stockholders | | | $(7,630) | | | $(9,938) |
Denominator | | | | | ||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | | | 3,648,367 | | | 3,659,456 |
Net loss attributable to common stockholders per share, basic and diluted | | | $(2.09) | | | $(2.72) |
| | As of December 31, | ||||
| | 2018 | | | 2019 | |
Options to purchase common stock | | | 1,344,635 | | | 1,385,304 |
Convertible preferred stock | | | 3,715,445 | | | 17,467,909 |
Total | | | 5,060,080 | | | 18,853,213 |
o) | Unaudited Pro Forma Net Loss Per Share |
| | Year Ended December 31, 2019 | |
Numerator | | | |
Net loss attributable to common stockholders | | | $(9,938) |
Denominator | | | |
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | | | 3,659,456 |
Adjust: Assumed weighted-average effect of conversion of convertible preferred stock | | | 7,141,320 |
Weighted-average shares outstanding used in computing pro forma net loss per share, basic and diluted | | | 10,800,776 |
Pro forma net loss per share, basic and diluted | | | $(0.92) |
p) | Recently Issued Accounting Standards |
3) | Property and Equipment |
| | December 31, | ||||
| | 2018 | | | 2019 | |
Furniture and fixtures | | | $ — | | | $72 |
Computers and equipment | | | — | | | 48 |
Computer software | | | — | | | 34 |
Total | | | $— | | | $154 |
4) | Accrued Expenses |
| | December 31, | ||||
| | 2018 | | | 2019 | |
Accrued research and development | | | $ — | | | $681 |
Accrued legal fees | | | — | | | 217 |
Accrued audit fees | | | — | | | 66 |
Other accruals | | | 25 | | | 25 |
Total | | | $25 | | | $989 |
5) | Fair Value Measurements |
Level 1: | Observable inputs such as quoted prices in active markets; |
Level 2: | Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and |
Level 3: | Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
6) | Stockholders’ Equity |
a) | Convertible Preferred Stock |
1) | Dividends |
2) | Preference on Liquidation |
3) | Conversion Rights |
4) | Redemption Rights |
5) | Voting |
b) | Common Stock |
| | As of December 31, | ||||
| | 2018 | | | 2019 | |
Convertible preferred stock | | | 3,715,445 | | | 17,467,909 |
Common stock options granted and outstanding | | | 1,344,635 | | | 1,385,304 |
Common stock reserved for future option grants | | | 261,240 | | | 3,114,593 |
Total common stock reserved for future issuance | | | 5,321,320 | | | 21,967,806 |
7) | Stock-Based Compensation |
| | Options | | | Weighted- Average Exercise Price | | | Weighted-Average Remaining Contractual Term (in years) | | | Aggregate Intrinsic Value (in thousands) | |
Outstanding at January 1, 2019 | | | 1,344,635 | | | $0.18 | | | 9.5 | | | |
Granted | | | 137,703 | | | 0.34 | | | 9.7 | | | |
Forfeited | | | (91,297) | | | 0.24 | | | 9.1 | | | |
Exercised | | | (5,737) | | | 0.18 | | | 8.5 | | | |
Outstanding at December 31, 2019 | | | 1,385,304 | | | $0.19 | | | 8.6 | | | $3,295 |
Exercisable at December 31, 2019 | | | 352,190 | | | $0.19 | | | 8.6 | | | $838 |
| | As of December 31 | ||||
| | 2018 | | | 2019 | |
Expected term (in years) | | | 10 | | | 10 |
Expected volatility | | | 110.5 - 110.7% | | | 95.9 - 98.7% |
Risk-free interest rate | | | 2.90 - 2.99% | | | 1.80 - 2.64% |
Expected dividend | | | 0% | | | 0% |
8) | Related Party Transactions |
a) | Management Service Agreement with Fount Therapeutics, LLC and Fount Service Corp. |
| | For the Period January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
FTL included in research and development | | | $— | | | $— |
FTL included in general and administrative | | | 617 | | | 841 |
Total FTL related party expense | | | 617 | | | 841 |
| | | | |||
FSC included in research and development | | | 1,454 | | | 2,301 |
FSC included in general and administrative | | | 983 | | | 1,768 |
Total FSC related party expense | | | 2,437 | | | 4,069 |
Total related party expenses | | | $3,054 | | | $4,910 |
| | As of December 31, | ||||
| | 2018 | | | 2019 | |
FTL related party receivables | | | $1,750 | | | $250 |
FTL related party payables | | | (1,315) | | | (20) |
FTL related party receivables, net | | | 435 | | | 230 |
| | | | |||
FSC related party receivables | | | 6,000 | | | 2,283 |
FSC related party payables | | | (5,357) | | | (1,540) |
FSC related party receivables, net | | | 643 | | | 743 |
Total related party receivables, net | | | $1,078 | | | $973 |
b) | Management Services Agreement with Subveho, LLC |
9) | Income Taxes |
| | For the Period January 4, 2018 (Inception) through December 31, 2018 | | | Year Ended December 31, 2019 | |
Income taxes computed at the statutory rate | | | $(1,602) | | | $(2,513) |
State income taxes, net of federal benefit | | | (532) | | | (825) |
Permanent items | | | 4 | | | 25 |
Stock-based compensation | | | — | | | 2 |
Change in valuation allowance | | | 2,130 | | | 3,311 |
Provision for income taxes | | | $— | | | $— |
| | As of December 31, | ||||
| | 2018 | | | 2019 | |
Deferred tax assets: | | | | | ||
Net operating loss carryforward | | | $2,093 | | | $5,404 |
Accruals and other | | | 37 | | | 37 |
Gross deferred tax assets: | | | 2,130 | | | 5,441 |
Less valuation allowance | | | (2,130) | | | (5,441) |
Total deferred tax assets | | | — | | | — |
Deferred tax liabilities: | | | | | ||
Fixed assets | | | — | | | — |
Net deferred tax assets | | | $— | | | $— |
10) | Commitments and Contingencies |
11) | Subsequent Events |
| | December 31, 2019 | | | September 30, 2020 | | | Pro Forma As of September 30, 2020 | |
| | | | (unaudited) | |||||
Assets | | | | | | | |||
Current assets: | | | | | | | |||
Cash and cash equivalents | | | $76,453 | | | $156,859 | | | |
Related party receivables, net (See Note 8) | | | 973 | | | — | | | |
Prepaid expenses | | | 25 | | | 620 | | | |
Total current assets | | | 77,451 | | | 157,479 | | | — |
Property and equipment | | | 154 | | | 316 | | | |
Deferred offering costs | | | — | | | 1,347 | | | |
Other assets | | | — | | | 55 | | | |
Total assets | | | $77,605 | | | $159,197 | | | $— |
Liabilities, Convertible Preferred Stock and Stockholders' (Deficit) Equity | | | | | | | |||
Current liabilities: | | | | | | | |||
Accounts payable | | | $956 | | | $2,328 | | | |
Accrued expenses | | | 989 | | | 4,371 | | | |
Total current liabilities | | | 1,945 | | | 6,699 | | | — |
Commitments and contingencies (See Note 9) | | | | | | | |||
Convertible preferred stock: | | | | | | | |||
Series A convertible preferred stock, $0.0001 par value; 7,762,733 shares authorized, 7,762,727 shares issued and outstanding at December 31, 2019 and September 30, 2020, respectively; aggregate liquidation preference of $19,167 at September 30, 2020, no shares issued and outstanding, pro forma | | | 18,942 | | | 18,942 | | | — |
Series B convertible preferred stock, $0.0001 par value; 9,705,185 shares authorized, 9,705,182 shares issued and outstanding at December 31, 2019 and September 30, 2020, respectively; aggregate liquidation preference of $74,500 at September 30, 2020, no shares issued and outstanding, pro forma | | | 74,204 | | | 74,187 | | | — |
Series C convertible preferred stock, $0.0001 par value; 0 and 8,282,803 shares authorized at December 31, 2019 and September 30, 2020, respectively; 0 and 8,282,789 shares issued and outstanding at December 31, 2019 and September 30, 2020, respectively; aggregate liquidation preference of $98,000 at September 30, 2020, no shares issued and outstanding, pro forma | | | — | | | 97,706 | | | — |
Stockholders’ (deficit) equity: | | | | | | | |||
Common stock, $0.0001 par value; 26,914,696 and 38,071,168 shares authorized at December 31, 2019 and September 30, 2020, respectively; 3,665,020 and 3,777,997 shares issued at December 31, 2019 and September 30, 2020, respectively; 3,665,020 and 3,748,782 shares outstanding at December 31, 2019 and September 30, 2020, respectively; 29,527,219 shares issued and outstanding, pro forma | | | — | | | — | | | 3 |
Additional paid—in capital | | | 82 | | | 1,360 | | | 192,192 |
Treasury stock at cost, 0 and 29,215 shares of common stock at December 31, 2019 and September 30, 2020, respectively | | | — | | | (75) | | | (75) |
Accumulated deficit | | | (17,568) | | | (39,622) | | | (39,622) |
Total stockholders’ (deficit) equity | | | (17,486) | | | (38,337) | | | 152,498 |
Total liabilities, convertible preferred stock and stockholders’ (deficit) equity | | | $77,605 | | | $159,197 | | |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
| | | | |||
Operating expenses: | | | | | ||
Research and development (includes related party amounts of $1,551 and $0, respectively) | | | $5,896 | | | $17,261 |
General and administrative (includes related party amounts of $1,827 and $92, respectively) | | | 2,131 | | | 5,021 |
Total operating expenses | | | 8,027 | | | 22,282 |
Loss from operations | | | (8,027) | | | (22,282) |
Other income: | | | | | ||
Interest income | | | — | | | 228 |
Total other income | | | — | | | 228 |
Net loss and comprehensive loss | | | $(8,027) | | | $(22,054) |
Gain on extinguishment of Series A convertible preferred stock | | | 2,031 | | | — |
Net loss attributable to common stockholders | | | $(5,996) | | | $(22,054) |
Weighted-average shares outstanding, basic and diluted | | | 3,659,283 | | | 3,709,020 |
Net loss attributable to common stockholders per share, basic and diluted | | | $(1.64) | | | $(5.95) |
Pro forma weighted-average shares outstanding, basic and diluted | | | | | 23,282,725 | |
Pro forma net loss attributable to common stockholders per share, basic and diluted | | | | | $(0.95) |
| | Series A Convertible Preferred Stock | | | Series B Convertible Preferred Stock | | | Series C Convertible Preferred Stock | | | Series A Convertible Preferred Stock | | | Common Stock | | | Additional Paid-in Capital | | | Accumulated Deficit | | | Treasury Stock | | | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||
| | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amount | | | Shares | | | Amounts | | | Shares | | | Amount | | |||||||||
Balance at January 1, 2019 | | | — | | | $— | | | — | | | $— | | | — | | | $— | | | 3,715,445 | | | $— | | | 3,659,283 | | | $— | | | $15,240 | | | $(7,630) | | | — | | | $— | | | 7,610 |
Issuance of Series A convertible preferred stock in merger | | | — | | | — | | | — | | | — | | | — | | | — | | | 1,617,208 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — |
Extinguishment of Series A convertible preferred stock | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (2,031) | | | 2,031 | | | — | | | — | | | — |
Issuance of Series A convertible preferred stock, net of issuance costs of $163 | | | — | | | — | | | — | | | — | | | — | | | — | | | 2,430,074 | | | — | | | — | | | — | | | 5,930 | | | — | | | — | | | — | | | 5,930 |
Net loss | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (8,027) | | | — | | | — | | | (8,027) |
Balance at September 30, 2019 | | | — | | | $— | | | — | | | $— | | | — | | | $— | | | 7,762,727 | | | $— | | | 3,659,283 | | | $— | | | $19,139 | | | $(13,626) | | | — | | | $— | | | $5,513 |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ||||||||||||||||
Balance at January 1, 2020 | | | 7,762,727 | | | $18,942 | | | 9,705,182 | | | $74,204 | | | — | | | $— | | | — | | | $— | | | 3,665,020 | | | $— | | | $82 | | | $(17,568) | | | — | | | $— | | | (17,486) |
Series B convertible preferred stock issuance costs | | | — | | | — | | | — | | | (17) | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — |
Issuance of Series C convertible preferred stock, net of issuance costs of $294 | | | — | | | — | | | — | | | — | | | 8,282,789 | | | 97,706 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — |
Stock-based compensation expense | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 1,252 | | | — | | | — | | | — | | | 1,252 |
Exercise of stock options | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 112,977 | | | — | | | 26 | | | — | | | — | | | — | | | 26 |
Treasury stock | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (29,215) | | | (75) | | | (75) |
Net loss | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (22,054) | | | — | | | — | | | (22,054) |
Balance at September 30, 2020 | | | 7,762,727 | | | $18,942 | | | 9,705,182 | | | $74,187 | | | 8,282,789 | | | $97,706 | | | — | | | $— | | | 3,777,997 | | | $— | | | $1,360 | | | $(39,622) | | | (29,215) | | | $(75) | | | $(38,337) |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
Cash flows from operating activities: | | | | | ||
Net loss | | | $(8,027) | | | $(22,054) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | ||
Stock-based compensation expense | | | — | | | 1,252 |
Depreciation expense | | | — | | | 59 |
Changes in operating assets and liabilities: | | | | | ||
Related party receivables, net | | | 422 | | | 1,127 |
Prepaid expenses and other assets | | | — | | | (650) |
Accounts payable and accrued expenses | | | 425 | | | 3,861 |
Net cash used in operating activities | | | (7,180) | | | (16,405) |
Cash flows from investing activities: | | | | | ||
Purchases of property and equipment | | | — | | | (359) |
Net cash used in investing activities | | | — | | | (359) |
Cash flows from financing activities: | | | | | ||
Proceeds from issuance of Series A convertible preferred stock, net of issuance costs | | | 5,930 | | | — |
Series B convertible preferred stock issuance costs | | | — | | | (17) |
Proceeds from issuance of Series C convertible preferred stock, net of issuance costs | | | — | | | 97,706 |
Payment of deferred offering costs | | | — | | | (470) |
Purchase of treasury stock | | | — | | | (75) |
Proceeds from stock option exercises | | | — | | | 26 |
Net cash provided by financing activities | | | 5,930 | | | 97,170 |
Net (decrease) increase in cash and cash equivalents | | | (1,250) | | | 80,406 |
Cash and cash equivalents at the beginning of the period | | | 6,999 | | | 76,453 |
Cash and cash equivalents at the end of the period | | | $5,749 | | | $156,859 |
Supplemental non-cash investing and financing activity: | | | | | ||
Property and equipment included in accounts payable and accrued expenses | | | $— | | | $16 |
Deferred offering costs included in accounts payable and accrued expenses | | | $— | | | $876 |
1) | Organization and Basis of Presentation |
a) | Organization and Nature of Operations |
b) | Basis of Presentation |
2) | Summary of Significant Accounting Policies |
a) | Unaudited Interim Financial Information |
b) | Deferred Offering Costs |
3) | Property and Equipment |
| | December 31, 2019 | | | September 30, 2020 | |
Furniture and fixtures | | | $72 | | | $72 |
Computers and equipment | | | 48 | | | 199 |
Computer software | | | 34 | | | 104 |
Total property and equipment | | | 154 | | | 375 |
Accumulated depreciation | | | — | | | (59) |
Total property and equipment, net | | | $154 | | | $316 |
4) | Accrued Expenses |
| | December 31, 2019 | | | September 30, 2020 | |
Accrued research and development | | | $681 | | | $2,476 |
Accrued legal fees | | | 217 | | | 848 |
Accrued audit fees | | | 66 | | | 116 |
Accrued payroll and related expenses | | | — | | | 739 |
Other accruals | | | 25 | | | 192 |
Total | | | $989 | | | $4,371 |
5) | Fair Value Measurements |
Level 1: | Observable inputs such as quoted prices in active markets; |
Level 2: | Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and |
Level 3: | Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
6) | Stockholders’ Equity |
a) | Convertible Preferred Stock |
1) | Dividends |
2) | Preference on Liquidation |
3) | Conversion Rights |
4) | Redemption Rights |
5) | Voting |
b) | Common Stock |
| | December 31, 2019 | | | September 30, 2020 | |
Convertible preferred stock | | | 17,467,909 | | | 25,778,437 |
Common stock options granted and outstanding | | | 1,385,304 | | | 5,700,154 |
Common stock reserved for future option grants | | | 3,114,593 | | | 1,117,217 |
Total common stock reserved for future issuance | | | 21,967,806 | | | 32,595,808 |
7) | Stock-Based Compensation |
| | Options | | | Weighted- Average Exercise Price | | | Weighted- Average Remaining Contractual Term (in years) | | | Aggregate Intrinsic Value (in thousands) | |
Outstanding at January 1, 2020 | | | 1,385,304 | | | $0.19 | | | 8.6 | | | |
Granted | | | 5,120,823 | | | 3.41 | | | 9.6 | | | |
Forfeited | | | (692,996) | | | 0.18 | | | 7.8 | | | |
Exercised | | | (112,977) | | | 0.23 | | | 7.9 | | | |
Outstanding at September 30, 2020 | | | 5,700,154 | | | $3.08 | | | 9.4 | | | $30,261 |
Exercisable at September 30, 2020 | | | 574,970 | | | $1.25 | | | 8.6 | | | $4,103 |
| | As of September 30, | ||||
| | 2019 | | | 2020 | |
Stock price | | | $0.18 - $0.34 | | | $2.57 - $5.63 |
Expected term (in years) | | | 10 | | | 6 - 7 |
Expected volatility | | | 95.9 - 98.7% | | | 87.5 - 89.2% |
Risk-free interest rate | | | 1.80 - 2.64% | | | 0.37 - 1.57% |
Expected dividend | | | 0% | | | 0% |
8) | Related Party Transactions |
a) | Management Services Agreement with Fount Therapeutics, LLC and Fount Service Corp. |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
FTL included in research and development | | | $— | | | $— |
FTL included in general and administrative | | | 627 | | | 80 |
Total FTL related party expense | | | 627 | | | 80 |
| | | | |||
FSC included in research and development | | | 1,551 | | | — |
FSC included in general and administrative | | | 1,200 | | | 12 |
Total FSC related party expense | | | 2,751 | | | 12 |
Total related party expenses | | | $3,378 | | | $92 |
| | December 31, 2019 | | | September 30, 2020 | |
FTL related party receivables | | | $250 | | | $— |
FTL related party payables | | | (20) | | | — |
FTL related party receivables, net | | | 230 | | | — |
| | | | |||
FSC related party receivables | | | 2,283 | | | — |
FSC related party payables | | | (1,540) | | | — |
FSC related party receivables, net | | | 743 | | | — |
Total related party receivables, net | | | $973 | | | $— |
b) | Management Services Agreement with Subveho, LLC |
9) | Commitments and Contingencies |
10) | Net Loss and Pro Forma Net Loss Per Share |
a) | Net Loss per Share |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
Numerator | | | | | ||
Net loss and comprehensive loss | | | $(8,027) | | | $(22,054) |
Gain on extinguishment of Series A convertible preferred stock | | | 2,031 | | | — |
Net loss attributable to common stockholders | | | $(5,996) | | | $(22,054) |
Denominator | | | | | ||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | | | 3,659,283 | | | 3,709,020 |
Net loss attributable to common stockholders per share, basic and diluted | | | $(1.64) | | | $(5.95) |
| | Nine Months Ended September 30, | ||||
| | 2019 | | | 2020 | |
Options to purchase common stock | | | 1,427,661 | | | 5,700,154 |
Convertible preferred stock | | | 7,762,727 | | | 25,778,437 |
Total | | | 9,190,388 | | | 31,478,591 |
b) | Pro Forma Net Loss Per Share |
| | Nine Months Ended September 30, 2020 | |
Numerator | | | |
Net loss attributable to common stockholders | | | $(22,054) |
Denominator | | | |
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | | | 3,709,020 |
Adjust: Assumed weighted-average effect of conversion of convertible preferred stock | | | 19,573,705 |
Weighted-average shares outstanding used in computing pro forma net loss per share, basic and diluted | | | 23,282,725 |
Pro forma net loss per share, basic and diluted | | | $(0.95) |
11) | Subsequent Events |
Goldman Sachs & Co. LLC | | | SVB Leerink | | | Piper Sandler |
| | | | |||
| | Wedbush PacGrow | | |
Item 13. | Other Expenses of Issuance and Distribution |
| | Amount Paid or to Be Paid | |
SEC registration fee | | | $27,415 |
FINRA filing fee | | | 38,192 |
Nasdaq listing fee | | | 210,000 |
Printing and engraving expenses | | | 175,000 |
Legal fees and expenses | | | 1,650,000 |
Accounting fees and expenses | | | 442,000 |
Transfer agent and registrar fees | | | 4,000 |
Miscellaneous expenses | | | 325,393 |
Total | | | $2,872,000 |
Item 14. | Indemnification of Directors and Officers |
Item 15. | Recent Sales Of Unregistered Securities |
(1) | In March 2018, June 2018 and October 2018, we issued and sold an aggregate of 2,826,970 shares of our Series A convertible preferred stock at a purchase price of $4.1269 per share for an aggregate purchase price of $11.7 million. |
(2) | In April 2019, we entered into an amended and restated Series A Preferred Stock Purchase Agreement pursuant to (i) which the number of shares issued in such 2018 financings was amended and restated to a new total of 4,725,138 and (ii) we issued and sold an additional 2,430,074 shares of our Series A convertible preferred stock at an updated purchase price of $2.47 per share for an aggregate purchase price of $6.0 million. |
(3) | In April 2019, we entered into an Agreement and Plan of Merger with Immanate Therapeutics Inc. (Immanate), pursuant to which we acquired Immanate in exchange for the issuance of 607,517 shares of our Series A convertible preferred stock. At the effective time of the merger, |
(3) | In December 2019, we issued and sold 9,705,182 shares of our Series B convertible preferred stock at a purchase price of $7.6763 per share for an aggregate purchase price of $74.5 million. |
(4) | In July and August 2020, we issued and sold 8,282,789 shares of our Series C convertible preferred stock at a purchase price of $11.8317 per share for an aggregate purchase price of $98.0 million. These shares are convertible into an aggregate of 8,310,528 shares of common stock. |
(5) | From the Company’s inception in January 2018 through December 2, 2020, we granted stock options to purchase an aggregate of 7,164,094 shares of common stock upon the exercise of options under our 2018 Plan at exercise prices per share ranging from $0.18 to $8.39, for an aggregate exercise price of approximately $22.3 million. |
(6) | From the Company’s inception in January 2018 through December 2, 2020, we issued and sold to certain employees and other service providers of ours an aggregate of 298,831 shares of common stock upon the exercise of options under our 2018 Plan at exercise prices per share ranging from $0.18 to $5.63, for an aggregate exercise price of approximately $119,139. |
Item 16. | Exhibit and Financial Statement Schedules |
(a) | Exhibits. |
(b) | Financial Statement Schedules. |
Item 17. | Undertakings |
(1) | For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act of 1933 shall be deemed to be part of this registration statement as of the time it was declared effective. |
(2) | For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
Exhibit number | | | Description |
| | Form of Underwriting Agreement. | |
| | Amended and Restated Certificate of Incorporation of the Registrant, as amended, as currently in effect. | |
| | Form of Amended and Restated Certificate of Incorporation of the Registrant, to be in effect upon the completion of this offering. | |
| | Bylaws of the Registrant, as currently in effect. | |
| | Form of Amended and Restated Bylaws of the Registrant, to be in effect upon the completion of this offering. | |
| | Amended and Restated Investors’ Rights Agreement by and among the Registrant and certain of its stockholders, dated August 24, 2020. | |
| | Specimen common stock certificate of the Registrant. | |
| | Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation. | |
| | Form of Indemnification Agreement between the Registrant and each of its directors and executive officers. | |
| | 2018 Equity Incentive Plan, as amended, and forms of agreement thereunder. | |
| | 2020 Equity Incentive Plan and forms of agreements thereunder, to be in effect upon the completion of this offering. | |
| | 2020 Employee Stock Purchase Plan and forms of agreements thereunder, to be in effect upon the completion of this offering. | |
| | Employment Letter between the Registrant and Nima Farzan. | |
| | Employment Letter between the Registrant and Mark Meltz. | |
| | Employment Letter between the Registrant and Eric Murphy, Ph.D. | |
| | Employment Letter between the Registrant and Richard Williams, MBBS, Ph.D. | |
| | Executive Incentive Compensation Plan. | |
| | Change in Control and Severance Agreement between the Registrant and Nima Farzan. | |
| | Change in Control and Severance Agreement between the Registrant and Mark Meltz. | |
| | Change in Control and Severance Agreement between the Registrant and Eric Murphy, Ph.D. | |
| | Change in Control and Severance Agreement between the Registrant and Richard Williams, MBBS, Ph.D. | |
| | Outside Director Compensation Policy. | |
| | Office Lease between the Registrant and Realty Income Properties 14, LLC, dated May 2, 2018, as amended by Amendment Number One dated May 5, 2020 and Amendment Number Two dated August 26, 2020, and the consent and assignment related thereto. | |
| | Amendment Number Three to Office Lease between the Registrant and Realty Income Properties 14, LLC, dated November 16, 2020. | |
| | Consent of KPMG LLP, Independent Registered Public Accounting Firm. | |
| | Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation (included in Exhibit 5.1). | |
| | Power of Attorney (see page II-6 to Form S-1 filed November 13, 2020). |
^ | Previously filed |
+ | Indicated management contract or compensatory plan. |
| | KINNATE BIOPHARMA INC. | ||||
| | | | |||
| | By: | | | /s/ Nima Farzan | |
| | | | Nima Farzan President and Chief Executive Officer |
Signature | | | Title | | | Date |
/s/ Nima Farzan | | | President, Chief Executive Officer and Director (Principal Executive Officer) | | | December 2, 2020 |
Nima Farzan | | |||||
/s/ Mark Meltz | | | Chief Operating Officer and General Counsel (Principal Financial and Accounting Officer) | | | December 2, 2020 |
Mark Meltz | | |||||
* | | | Chair of the Board | | | December 2, 2020 |
Dean Mitchell | | |||||
* | | | Director | | | December 2, 2020 |
Melissa Epperly | | |||||
* | | | Director | | | December 2, 2020 |
Keith Flaherty, M.D. | | |||||
* | | | Director | | | December 2, 2020 |
Carl Gordon, Ph.D. | | |||||
* | | | Director | | | December 2, 2020 |
Stephen Kaldor, Ph.D. | | |||||
* | | | Director | | | December 2, 2020 |
Michael Rome, Ph.D. | | |||||
* | | | Director | | | December 2, 2020 |
Laurie Smaldone Alsup, M.D. | | |||||
* | | | Director | | | December 2, 2020 |
Jim Tananbaum, M.D. | |
*By: | | | /s/ Nima Farzan | | | |
Nima Farzan, Attorney-in-fact | | |
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Wilson Sonsini Goodrich & Rosati
Professional Corporation
650 Page Mill Road
Palo Alto, California 94304-1050 o: 650.493.9300
f: 650.493.6811 |
Very truly yours,
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/s/ Wilson Sonsini Goodrich & Rosati
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WILSON SONSINI GOODRICH & ROSATI
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Professional Corporation
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