UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported)
(Exact name of Registrant as specified in its charter)
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(Address of principal executive offices) (Zip code)
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(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Preferred Share Purchase Rights |
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The (The Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Chief Medical Officer
On November 2, 2020, DURECT Corporation (the “Company”) appointed Norman L. Sussman, MD FAASLD, age 68, as its Chief Medical Officer. Dr. Sussman has extensive clinical experience and expertise in the liver disease field and brings over 30 years of clinical research and development experience in academia and industry. He joins DURECT from Baylor College of Medicine, where he was an Associate Professor of Medicine and Surgery. Dr. Sussman has been a faculty member of Baylor College of Medicine intermittently since 1985. During this time, he has served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman has also had leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke’s Medical Center.
Dr. Sussman received his MBBCh from the University of the Witwatersrand in Johannesburg, South Africa. He then completed his residency at St. Louis University Hospital and his post-doctoral fellowship at Washington University. He is Board Certified in Internal Medicine, Gastroenterology, and Transplant Hepatology. Dr. Sussman is also a Fellow of the American Association of the Study of Liver Disease, which is a designation that recognizes his superior level of professional achievement in the field of hepatology.
In connection with his appointment, the Company and Dr. Sussman entered into an offer letter (the “Offer Letter”). Pursuant to the Offer Letter, Dr. Sussman will receive a base salary of $400,000 annually. Dr. Sussman is eligible to receive an annual bonus equal to 40% of his base salary (pro-rated for 2020). In connection with the start of his employment, Dr. Sussman was provided with a relocation allowance of $250,000, less applicable income and employment taxes (partially refundable if his employment is terminated for cause (as defined in the Company’s Change of Control Policy). He will also be granted a stock option to purchase 200,000 shares of the Company’s common stock that will vest over a four-year period with a one-year cliff. Additionally, Dr. Sussman will be granted a stock option to purchase 50,000 shares of the Company’s common stock which will vest immediately upon the first FDA approval of a DUR-928 New Drug Application. Dr. Sussman is eligible to participate in the Company’s employee benefit plans on the same basis as generally made available to other employees of the Company, and he will enter into the Company’s standard form of indemnification agreement for the Company’s officers and directors. Dr. Sussman’s stock option awards will be subject to the terms of the Company’s Change of Control Policy, which provides for certain vesting and severance benefits for officers in the event of termination in connection with a change of control.
The foregoing description of the Offer Letter is not complete and is qualified in its entirety by reference to the full text of the Offer Letter which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
On November 2, 2020, DURECT issued a press release attached hereto as Exhibit 99.1 and incorporated herein by reference relating to the appointment described above.
There are no family relationships between Dr. Sussman and any director or officer of the Company and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
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Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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10.1* |
Offer letter between Norman L. Sussman and DURECT Corporation dated October 12, 2020 |
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99.1 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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* Management contract or compensatory plan or arrangement.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DURECT Corporation |
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Date: November 2, 2020 |
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By: |
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/s/ James E. Brown |
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James E. Brown President and Chief Executive Officer
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Exhibit 10.1
October 12, 2020
Norman L Sussman, MD FAASLD
Via electronic delivery
Dear Norman:
It is a pleasure to confirm the offer extended to you to join DURECT Corporation, located at 10260 Bubb Road, Cupertino, California, 95014, as Chief Medical Officer, reporting directly to the Chief Executive Officer. We would like your start date to be November 2, 2020, but will depend on when you successfully complete a pre-employment drug screening and background verification. As an exempt, regular employee, your starting semi-monthly salary will be $16,666.67, which equates to $400,000.00 on an annual basis. In addition, within 30 days following your commencement of employment, you will be granted an option to purchase 200,000 shares of DURECT Common Stock. The vesting associated with these options are as follows: Stock options shall vest as to one-fourth (1/4) of the total shares subject to the option on the one-year anniversary of the date of grant and as to one-sixteenth (1/16) of the total shares subject to the option at the end of each three-month period following the one-year anniversary of the grant. The per share exercise price for these options will be the fair market value of DURECT Corporation’s Common Stock on the date of the grant of the options.
Additionally, within 30 days following your commencement of employment, you will be granted an option to purchase 50,000 shares of DURECT Common Stock to be vested immediately upon the first FDA approval of a DUR-928 New Drug Application (NDA). The per share exercise price for these options will be the fair market value of DURECT Corporation’s Common Stock on the date of the grant of the options. You will be eligible for annual equity grants commensurate with your position as Chief Medical Officer beginning calendar year 2021.
DURECT will provide you with a relocation allowance of $250,000.00, less applicable income and employment taxes withheld. DURECT will reimburse you for eligible expenses you incur up to a maximum of the amount of the relocation allowance. Eligible expenses will include (1) commute travel to and from DURECT’s offices in California, including airfare to and from California from Texas prior to your moving to California; (2) rent or hotel, rental car, etc. incurred when you travel to California to work at DURECT’s offices in California prior to your moving to California; and (3) expenses related to relocating from your home in Texas to California (or purchasing, leasing or renting a second home in California) such as travel to look at homes, moving expenses, rent, down payment on a home or condominium, mortgage payments, etc. Any amount of such expenses you incur above the relocation allowance amount will not be reimbursed by DURECT. For clarity, business travel on behalf of the company will be reimbursed separately according to DURECT’s travel policy and will not count against the relocation allowance. As a condition of
DURECT Corporation | 10260 Bubb Road | Cupertino, CA 95014 | 408.777.1417CONFIDENTIAL
receiving the relocation allowance, you agree that if you voluntarily terminate your employment (other than as a result of your death, disability or constructive termination as defined in the Change of Control policy) during the first two years with DURECT Corporation, or if your employment is terminated by DURECT Corporation for cause (as defined in the Change of Control policy), you agree that you will repay a pro-rated portion of your reimbursed eligible expenses back to the company. The prorated portion to be repaid will be calculated by multiplying the amount of reimbursed eligible expenses (only those expenses listed under eligible expenses (3) above) by a fraction, the numerator of which will be equal to twenty-four minus the number of full months you were employed since your start date, and the denominator of which is twenty-four. You will be responsible for any income and employment taxes incurred as a result of DURECT reimbursing you for these eligible expenses.
You will be eligible for the equivalent annual bonus that all other Chief-level employees of the Company are eligible for, which is currently 40% of your annual base salary, with a breakdown of 95% based on corporate and 5% from personal objectives. This bonus will be subject to pro-ration based on your start date.
In addition, your option awards will be subject to the terms of the Company’s change of control policy, which provides for certain vesting and severance benefits for Vice Presidents and above in the event of a qualifying termination of employment in connection with or within twenty-four months following a change in control.
Benefits
Effective the first of the month following your start date, you will be eligible to participate in the benefits enjoyed by an indefinite term employee, including medical, dental, vision, life and disability insurances. You will be eligible for paid holidays, vacation accrual, and sick leave. You may elect to participate in the 401(k) savings plan, the Employee Stock Purchase Plan, and a Section 125 Cafeteria Plan according to the terms and conditions governing participation in the plans. If the terms and conditions governing any such benefit plan differ from any provision of
this letter, the plan documents containing these terms and conditions will govern and take precedence. The Company agrees to pay your reasonable legal expenses incurred in the negotiation of this agreement.
This offer is contingent upon successful completion of a background investigation and pre-employment drug screening test due to the fact that DURECT is engaged in the development and manufacture of pharmaceutical products, including controlled substances. Your representing agency, Spencer Stuart, will conduct your background investigation. As for your pre-employment drug screening test, you will be notified by Justifacts Credential Verification, Inc. and given instruction on how to complete the drug check verification. This must be completed and returned prior to your start date.
Authorization to Work
Federal regulations require that you establish your identity and authorization to work in this country, so this offer is necessarily contingent upon such proof. Enclosed is a description of the
DURECT Corporation | 10260 Bubb Road | Cupertino, CA 95014 | 408.777.1417CONFIDENTIAL
original documents you will be required to bring on your first day of work, at which time we will meet with you to examine the original documents and ask that you complete the required “INS” form in our presence.
Agreements
The enclosed “Confidential Information and Invention Assignment Agreement” must be signed by you before you start your first day of work. Please sign both copies of the Agreement and return one copy. You may retain the duplicate for your records.
Your employment at DURECT is for an unspecified period of time and your relationship with the Company is and shall continue to be at-will, as defined under applicable law, meaning that either you or DURECT may terminate your employment relationship at any time for any reason or no reason, with or without notice.
Please indicate that these terms and conditions are acceptable and confirm your acceptance of this offer by signing and dating the original of this letter and returning it by October 14, 2020. You may retain a duplicate for your records.
Congratulations on your offer to join DURECT Corporation; we look forward to working with you. Please do not hesitate to call me directly at (408) 777-1419 if you have any questions.
Sincerely,
/s/ James E. Brown, President & CEO
James E. Brown
President and Chief Executive Officer
JEB/bs
Enclosures
Understood and accepted:
Signature /s/ Norman L. Sussman, MD, FAASLDDate12-Oct-2020
Norman Sussman, MD FAASLD
DURECT Corporation | 10260 Bubb Road | Cupertino, CA 95014 | 408.777.1417CONFIDENTIAL
Exhibit 99.1
DURECT Corporation Appoints Dr. Norman Sussman as Chief Medical Officer
CUPERTINO, Calif., November 2, 2020/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a biopharmaceutical company focused on the development of treatments for acute organ injury and chronic liver diseases, today announced it has appointed Norman Sussman, M.D. as its Chief Medical Officer, effective immediately. In this new role, Dr. Sussman will oversee the clinical development of DURECT’s pipeline including multiple indications for its lead investigational drug candidate DUR-928.
“We are excited to welcome Dr. Sussman as our Chief Medical Officer as we continue to advance DUR-928 through clinical development for the treatment of alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), and other indications,” stated James E. Brown, D.V.M., President and Chief Executive Officer of DURECT. “Dr. Sussman is a renowned hepatologist with a proven track record in clinical research of liver diseases. We believe he will provide critical support in advancing our clinical programs and we look forward to his contributions.”
Dr. Sussman commented, “I am delighted to be joining DURECT at this exciting time for the company as it prepares to initiate dosing in a potentially pivotal Phase 2b trial in AH and continues to advance clinical programs for other indications involving acute organ injury and chronic liver diseases. DUR-928 is an epigenetic regulator with a unique mechanism of action that has potential to transform the treatment of these diseases. I look forward to leveraging my clinical experience as I join a talented and dedicated team at DURECT working to bring desperately needed, potentially life-saving therapies to patients with no good therapeutic options.”
Dr. Sussman has extensive clinical experience and expertise in the liver disease field and brings over 30 years of clinical research and development experience in academia and industry. He joins DURECT from Baylor College of Medicine, where he was an Associate Professor of Medicine and Surgery. Dr. Sussman has been a faculty member of Baylor College of Medicine intermittently since 1985. During this time, he has served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman has also had leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke’s Medical Center.
Dr. Sussman received his MBBCh from the University of the Witwatersrand in Johannesburg, South Africa. He then completed his residency at St. Louis University Hospital and his post-doctoral fellowship at Washington University. He is Board Certified in Internal Medicine, Gastroenterology, and Transplant Hepatology. Dr. Sussman is also a Fellow of the American Association of the Study of Liver Disease, which is a designation that recognizes his superior level of professional achievement in the field of hepatology.
About DURECT Corporation
DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DURECT’s lead candidate, DUR-928 is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique
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mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. This drug candidate is in Phase 2 development for the treatment of alcoholic hepatitis (AH) and the treatment of COVID-19 patients with acute liver or kidney injury as well as Phase 1 development for the treatment of nonalcoholic steatohepatitis (NASH). DURECT’s proprietary drug delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (bupivacaine sustained-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking Statement
The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life saving potential of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company’s other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 4, 2020 under the heading “Risk Factors.”
NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.
Corporate ContactMedia Contact
Mike Arenberg Alison Chen
DURECTLifeSci Communications
Chief Financial Officer+1-646-876-4932
+1-408-346-1052achen@lifescicomms.com
mike.arenberg@durect.com
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Document and Entity Information |
Nov. 02, 2020 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Nov. 02, 2020 |
Title of 12(b) Security | Common Stock $0.0001 par value per share |
Security Exchange Name | NASDAQ |
Trading Symbol | DRRX |
Entity Registrant Name | DURECT CORP |
Entity Central Index Key | 0001082038 |
Entity Emerging Growth Company | false |
Entity File Number | 000-31615 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 94-3297098 |
Entity Address, Address Line One | 10260 Bubb Road |
Entity Address, City or Town | Cupertino |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 95014 |
City Area Code | 408 |
Local Phone Number | 777-1417 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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