What changed in this filing

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Item 1A. Risk Factors

2021-11-04 compared with 2021-08-05 · 25 added, 30 removed, 1136 unchanged (5% of the section changed)

221 unchanged sentences

Undesirable side effects may be identified in clinical trials that EB Pharma may conduct in virology indications, which may negatively impact the development, commercialization or potential value of tipifarnib.

We are currently conducting a Phase 1/2 clinical trial to evaluate KO-539 in relapsed or refractory AML.

We are currently conducting the Phase 1b portion of our Phase 1/2 clinical trial to evaluate KO-539 in relapsed or refractory AML.

Any observed, drug-related side effects could affect the ability of patients to tolerate potentially therapeutically effective doses of the drug, which in turn could affect patient recruitment or the ability of enrolled patients to complete the clinical trial or result in potential product liability claims.

148 unchanged sentences

We rely, and expect to continue to rely, on third parties for the manufacture of clinical supplies of tipifarnib and KO-539 for preclinical and clinical testing.

We will rely on third parties as well for commercial manufacture if any of our product candidates receive marketing approval.

We expect to rely on third parties as well for commercial manufacture if any of our product candidates receive marketing approval.

This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

170 unchanged sentences

Further, prior to the U.S.

Supreme Court ruling on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021 and will remain open through August 15, 2021.

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

17 unchanged sentences

On November 20, 2020, CMS issued an interim final rule implementing President Trump’s Most Favored Nation executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021.

On December 28, 2020, the United States District Court in Northern California issued a nationwide preliminary injunction against implementation of the interim final rule.

On January 13, 2021, in a separate lawsuit brought by industry groups in the U.S.

District of Maryland, the government defendants entered a joint motion to stay litigation on the condition that the government would not appeal the preliminary injunction granted in the U.S.

District Court for the Northern District of California and that performance for any final regulation stemming from the Most Favored Nation Model interim final rule shall not commence earlier than 60 days after publication of that regulation in the Federal Register.

Additionally, based on a recent executive order, the Biden administration expressed its intent to pursue certain policy initiatives to reduce drug prices .

As a result of litigation challenging the Most Favored Nation Model , on August 10, 2021, CMS published a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule .

In July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs.

In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue to advance these principles.

In addition, Congress is considering drug pricing as part of the budget reconciliation process .

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

21 unchanged sentences

We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against

potential liabilities.

We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

14 unchanged sentences

In addition, the U.S.

PTO issued us patents directed to the treatment of HRAS mutant HNSCC with a farnesyl transferase inhibitor and corresponding patents have been issued in a number of foreign jurisdictions, including Europe.

PTO and several foreign jurisdictions also issued us patents directed to the method of treatment of AITL with tipifarnib and the method of treatment of CXCL12-expressing PTCL or AML with tipifarnib, as well as patents directed to the method of treatment of AITL, and the method of treatment of CXCL12-expressing PTCL or AML with a farnesyl transferase inhibitor.

33 unchanged sentences

As a result, our current business plans are dependent upon our satisfaction of certain conditions to the maintenance of the Janssen agreement and the rights we license under it and our other in-license agreements.

The Janssen license agreement and the University of Michigan license agreement each provide that we are subject to diligence obligations relating to the commercialization and development of the respective product candidates, milestone payments, royalty payments and other obligations.

If we fail to comply with any of the conditions or obligations or otherwise breach the terms of our license agreement with Janssen, University of Michigan or any of our other license agreements or license agreements we may enter into on which our business or product candidates are dependent, Janssen, University of Michigan or other licensors may have the right to terminate the applicable agreement in whole or in part and thereby extinguish our rights to the licensed technology and intellectual property and/or any rights we have acquired to develop and commercialize certain product candidates.

The loss of the rights licensed to us under our license agreement with Janssen, University of Michigan or our other license agreements or any future license agreement that we may enter granting us rights on which our business or product candidates are dependent, would eliminate our ability to further develop the applicable product candidates and would materially harm our business, prospects, financial condition and results of operations.

The Janssen license agreement and the University of Michigan license agreement each provides that we are subject to diligence obligations relating to the commercialization and development of the respective product candidates, milestone payments, royalty payments and other obligations.

If we fail to comply with any of the conditions or obligations or otherwise breach the terms of our license agreement with Janssen, or University of Michigan, or any of our other license agreements or license agreements we may enter into on which our business or product candidates are dependent, Janssen, University of Michigan or other licensors may have the right to terminate the applicable agreement in whole or in part and thereby extinguish our rights to the licensed technology and intellectual property and/or any rights we have acquired to develop and commercialize certain product candidates.

The loss of the rights licensed to us under our license agreement with Janssen, or University of Michigan, or our other license agreements or any future license agreement that we may enter granting us rights on which our business or product candidates are dependent, would eliminate our ability to further develop the applicable product candidates and would materially harm our business, prospects, financial condition and results of operations.

Disputes may arise regarding intellectual property subject to, and any of our rights and obligations under, any license or other strategic agreement, including:

85 unchanged sentences

Presently we have rights to intellectual property under an exclusive license from Janssen to develop tipifarnib in all fields other than virology, an exclusive worldwide license from the University of Michigan for all therapeutic indications for KO-539 and other compounds in our menin-KMT2A program and an exclusive worldwide license from Memorial Sloan Kettering Cancer Center to a patent family pertaining to a method of use of tipifarnib.

Because our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of our business

may depend in part on our ability to acquire, in-license or use these proprietary rights.

Because our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of our business may depend

in part on our ability to acquire, in-license or use these proprietary rights.

Additionally, a companion diagnostic may require that we or a third-party collaborator developing the diagnostic acquire proprietary rights held by third parties, which may not be available.

82 unchanged sentences

That competitor has received Fast Track Designation from the FDA.

If that competitor is able to advance their clinical program more quickly than ours, our commercial opportunity for KO-539 could be reduced.

If any competitor is able to advance their clinical program more quickly than ours, our commercial opportunity for KO-539 could be reduced.

Our commercial opportunity also could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop alone or in combination with other drugs or biologics.

65 unchanged sentences

We currently have a limited number of employees, are highly dependent on our Chief Executive Officer and our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

We are a clinical-stage company with a limited operating history, and, as of June 30, 2021, we had 111 full-time employees.

We are a clinical-stage company with a limited operating history, and, as of September 30, 2021, we had 116 full-time employees.

We are highly dependent on the expertise of Troy E.

48 unchanged sentences

Our common stock has been listed on the Nasdaq Global Select Market, or Nasdaq, under the symbol “KURA” since November 5, 2015.

The high and low price per share of our common stock as reported by Nasdaq during the period from November 5, 2015 through June 30, 2021, were $43.00 and $2.50, respectively .

The high and low price per share of our common stock as reported by Nasdaq during the period from November 5, 2015 through September 30, 2021, were $43.00 and $2.50, respectively .

We cannot predict the extent to which investor interest in our company will sustain an active trading market on Nasdaq or any other exchange in the future.

5 unchanged sentences

The market for our common stock could fluctuate substantially due to a variety of factors, some of which may be beyond our control.

In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include:

In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Quarterly Report, these factors include:

the product candidates we seek to pursue, and our ability to obtain rights to develop, commercialize and market those product candidates;

69 unchanged sentences

Pursuant to our Amended and Restated 2014 Equity Incentive Plan, or 2014 Plan, we are authorized to grant equity awards consisting of shares of our common stock to our employees, directors and consultants.

As of June 30, 2021, we had 1,316,828 shares of common stock reserved for future issuance under the 2014 Plan, options to purchase up to an aggregate of 6,779,809 shares of common stock outstanding and 182,256 unvested restricted stock units outstanding.

As of September 30, 2021, we had 1,172,524 shares of common stock reserved for future issuance under the 2014 Plan, options to purchase up to an aggregate of 6,735,278 shares of common stock outstanding and 162,456 unvested restricted stock units outstanding.

The number of shares available for future grant under the 2014 Plan will automatically increase on January 1 of each year through January 1, 2025 by 4% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year.

1 unchanged sentence

In addition, we may grant or provide for the grant of rights to purchase shares of our common stock pursuant to our 2015 Employee Stock Purchase Plan , or ESPP.

As of June 30, 2021, we had 144,285 shares of common stock reserved for future issuance under the ESPP.

The number of shares of our common stock reserved for issuance under the ESPP will automatically increase on January 1 of each calendar year through January 1, 2025 by the lesser of 1% of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year and 2,000,000 shares, subject to the ability of our

board of directors to take action to reduce the size of the increase in any given year.

As of September 30, 2021, we had 144,285 shares of common stock reserved for future issuance under the ESPP.

ability of our board of directors to take action to reduce the size of the increase in any given year.

In December 20 20 , the board of directors elected not to automatically increase the number of shares of our common stock reserved for issuance under the ESPP in 202 1 .

In addition, a warrant to purchase up to 33,988 shares of our common stock at an exercise price of $3.31 per share was outstanding as of June 30, 2021 .

In addition, a warrant to purchase up to 33,988 shares of our common stock at an exercise price of $3.31 per share was outstanding as of September 30, 2021 .

Any future grants of options, warrants or other securities exercisable or convertible into our common stock, or the exercise or conversion of such shares, and any sales of such shares in the market, could have an adverse effect on the market price of our common stock.

106 unchanged sentences

(Exhibit 4.3)

Lease Agreement, dated May 11, 2021, by and between the Registrant and BP3-SD5 5510 Morehouse Drive LLC.

First Amendment to Amended and Restated Executive Employment Agreement, effective as of June 30, 2021, by and between the Registrant and Bridget Martell .

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

8 unchanged sentences

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.INS).

Indicates management contract or compensatory plan.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

1 unchanged sentence

A Delaware corporation

August 5, 2021

November 4, 2021

Wilson, Ph.D., J.D.

2 unchanged sentences

(Principal Executive Officer)

August 5, 2021

November 4, 2021

/s/ Marc Grasso, M.D.

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors