Viridian Therapeutics, Inc.DE false 0001590750 0001590750 2024-01-03 2024-01-03

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 3, 2024

 

 

 

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VIRIDIAN THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36483   47-1187261

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

221 Crescent Street, Suite 401

Waltham, MA

  02453
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 272-4600

N/A

(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:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

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:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.01 par value   VRDN   The Nasdaq Stock Market LLC

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. ☐

 

 

 


Item 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Departure of Chief Medical Officer

On January 3, 2024, after discussions with Viridian Therapeutics, Inc. (the “Company”) regarding his future plans, Dr. Barrett Katz, age 74, transitioned to a consulting role and ceased to serve as Chief Medical Officer of the Company. He is succeeded in the role by Dr. Thomas Ciulla, the Company’s former Chief Development Officer.

The Company entered into a separation agreement (the “Separation Agreement”) with Dr. Katz on January 3, 2024 (the “Separation Date”). Pursuant to the terms of the Separation Agreement, Dr. Katz will be entitled to receive the following severance benefits: (i) continued payment of his current annual base salary for a period of 52 weeks following the Separation Date in the amount of $502,228, (ii) a one-time payment equal to 105% of his target annual performance bonus amount in the amount of $210,935.76, (iii) an additional one-time payment equal to 100% of his target annual performance bonus amount in the amount of $200,891.20, (iv) immediate vesting of all stock options and equity awards subject to time-based vesting that were previously made to Dr. Katz outstanding as of January 18, 2021 that would have otherwise vested based on continued employment for a period of 12 months following the Separation Date and (v) a one-time payment of Dr. Katz’s COBRA or other healthcare payments in the amount of $24,000. The payment of the foregoing benefits under the Separation Agreement is conditioned upon the general release of claims in favor of the Company included in the Separation Agreement becoming effective and non-revocable.

Dr. Katz will continue to serve as a consultant to the Company pursuant to a consulting agreement between him and the Company (the “Consulting Agreement”) dated January 3, 2024, for up to one year, unless earlier terminated by either party or extended by mutual written agreement. In exchange for providing consulting services under the Consulting Agreement, Dr. Katz will receive a consulting fee of $10,000 per month during the term of the Consulting Agreement. Pursuant to the terms of the Consulting Agreement, on January 4, 2024, Dr. Katz was also awarded an option to purchase up to 67,500 shares of the Company’s common stock, par value $0.01 per share, at an exercise price of $22.00 per share (the closing stock price on the date of grant). This option will vest in full on January 1, 2025 subject to (i) his continuous engagement with the Company and (ii) the Consulting Agreement not having been earlier terminated.

Appointment of Chief Medical Officer

The Board of Directors of the Company appointed Dr. Thomas Ciulla, formerly the Company’s Chief Development Officer since February 2023, as Chief Medical Officer of the Company effective January 3, 2024.

Dr. Ciulla, age 59, previously served as Chief Medical Officer and Chief Development Officer at Clearside Bio (“Clearside”) from October 2018 to February 2023, where he guided preclinical and clinical development, supported a New Drug Application to the first U.S. Food and Drug Administration (“FDA”) approval of a suprachoroidal therapy, led an Investigational New Drug submission with development of a new clinical program and successful Phase 1/2 trial and oversaw medical and professional affairs. Prior to Clearside, Dr. Ciulla served in a Vice President role as Medical Strategy Lead-Ophthalmology at Spark Therapeutics from August 2017 to October 2018, where he defined and led medical strategy to support development and commercialization of the first FDA-approved gene therapy for a genetic disease. He previously served as Vice President, Clinical Strategy at Ophthotech Corporation (now Iveric Bio, Inc.) from January 2016 to August 2017.

Before launching his executive management career, Dr. Ciulla co-directed the retina service and ocular angiogenesis research lab at Indiana University School of Medicine, the largest U.S. medical school. He remains a volunteer Clinical Professor at the university and is a Fellow of the American Society of Retina Specialists, member of the American Society of Gene and Cell Therapy, Association for Research in Vision and Ophthalmology, Macula Society, Retina Society and the American Academy of Ophthalmology.

Dr. Ciulla has held numerous leadership roles in clinical research, including principal investigator, medical monitor, and member of scientific advisory, data safety monitoring or writing committees in more than 100 national clinical trials. He has served on journal editorial boards, edited several textbooks, presented at more than 200 conferences, and co-authored more than 300 publications. Dr. Ciulla graduated from Harvard College and UCSF School of Medicine, followed by an internship and residency at Harvard Medical School and a fellowship at Tufts Medical School. He also earned an M.B.A. from Indiana University’s Kelley School of Business, specializing in the business of medicine.


Item 7.01

Regulation FD Disclosure.

On January 8, 2024, the Company issued a press release announcing (i) that it will present the Company’s key 2024 corporate priorities at the 42nd Annual J.P. Morgan Healthcare Conference, (ii) the appointment of Dr. Ciulla as the Company’s Chief Medical Officer and (iii) certain other corporate updates.

A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit Number    Exhibit Description
99.1    Press release, dated January 8, 2024
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


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.

 

    Viridian Therapeutics, Inc.
Date: January 8, 2024     By:  

/s/ Stephen Mahoney

      Stephen Mahoney
      President, Chief Executive Officer, and Director

Exhibit 99.1

 

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Viridian Therapeutics to Present Key 2024 Corporate Priorities at J.P. Morgan Healthcare Conference

- VRDN-001 topline clinical results for THRIVE and THRIVE-2 on track for mid-2024 and year-end 2024 in patients with active and chronic thyroid eye disease (TED), respectively -

- Subcutaneous VRDN-003 pivotal study in TED anticipated to start in mid-2024, pending alignment with regulatory authorities -

- Anti-neonatal Fc receptor (FcRn) portfolio progressing as planned with VRDN-006 IND anticipated by year-end 2024 and VRDN-008 data in non-human primates in 2H 2024 -

- Tom Ciulla, M.D., M.B.A. promoted to Chief Medical Officer to succeed Barrett Katz, M.D., M.B.A. -

WALTHAM, Mass.—January 8, 2024—Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that President and Chief Executive Officer, Steve Mahoney, will discuss the company’s progress at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

As part of Viridian’s presentation at the J.P. Morgan Healthcare Conference, Mr. Mahoney will provide key updates on the company’s anti-insulin-like growth factor 1 receptor (IGF-1R) programs in thyroid eye disease (TED) and its programs targeting FcRn. Viridian aims to build a world-class portfolio in TED with a differentiated and fast-to-market lead asset in VRDN-001, which is delivered intravenously, and a potential best-in-class asset, VRDN-003, which is designed to be self-administered subcutaneously at home as an infrequent and low-volume injection. In addition to TED, the company is also developing a novel portfolio of FcRn inhibitors with VRDN-006, an Fc fragment, and VRDN-008, which is engineered to have an extended half-life with the goal to prolong immunoglobulin G (IgG) suppression.

“2024 is poised to be a year with major catalysts for Viridian as we advance VRDN-001 towards topline data in two global Phase 3 studies in active and chronic TED, expected by the middle and end of the year, respectively,” said Mr. Mahoney. “In addition, we were thrilled by the positive data that exceeded our expectations from our healthy volunteer studies in December 2023 that led to the selection of VRDN-003 as our potential best-in-class subcutaneous program. We plan to initiate the VRDN-003 pivotal program in mid-2024, pending alignment with regulatory authorities, as we aim to decrease the treatment burden on patients and their families living with TED. We are equally excited by the progress in our FcRn portfolio. We look forward to submitting an Investigational New Drug Application (IND) for VRDN-006 by the end of the year and providing additional details on VRDN-008 in the second half of the year.”

Thyroid Eye Disease Portfolio: VRDN-001 and VRDN-003

Intravenous VRDN-001

Viridian’s lead product candidate, VRDN-001, is a monoclonal antibody that acts as a full antagonist of IGF-1R, a clinically and commercially validated target for TED that has current US annual revenues close to $2 billion. Viridian is currently evaluating VRDN-001 in two global Phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose treatment arm of VRDN-001, dosed three weeks apart, to placebo. This five-dose VRDN-001 regimen features fewer infusions and a shorter time per infusion compared to the currently marketed IGF-1R inhibitor. The company expects to report THRIVE and THRIVE-2 data in the middle of 2024 and by year end 2024, respectively.

THRIVE and THRIVE-2 data will look to confirm the Phase 2 data Viridian reported throughout 2022 and 2023. In all dose cohorts of a Phase 2 clinical trial, intravenous VRDN-001 was shown to improve the signs and symptoms of TED at six weeks in patients with active and chronic disease after two infusions. VRDN-001 was also well-tolerated.


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Subcutaneous VRDN-003

In December 2023, the company selected VRDN-003 as the potential best-in-class subcutaneous anti-IGF-1R program for pivotal development in TED following positive data in a Phase 1 clinical trial in healthy volunteers. VRDN-003 has the same binding domain as its parent molecule, VRDN-001, and was engineered to have a longer half-life. VRDN-003 is designed to maintain the clinical response of VRDN-001 IV while increasing patient convenience.

The Phase 1 clinical study showed VRDN-003 to have a prolonged half-life of 40-50 days, which is four to five times that of its parent molecule, VRDN-001. Because VRDN-001 and VRDN-003 are nearly identical antibodies, the company expects VRDN-003 to have similar clinical responses at the exposure levels of VRDN-001 that led to robust clinical activity in its Phase 2 clinical study in TED. Further, pharmacokinetic modeling of VRDN-003 predicted that dosing regimens as long as every 8 weeks would achieve or exceed VRDN-001 exposure levels that were clinically meaningful. Based on these results, the company expects to initiate a global pivotal program with VRDN-003 in mid-2024, with planned trials in both active and chronic TED patients, pending alignment with regulatory authorities.

Anti-FcRn Portfolio: VRDN-006 and VRDN-008

In October 2023, consistent with Viridian’s vision to develop the next generation of best-in-class products for severe autoimmune and rare diseases, the company unveiled a portfolio of engineered FcRn inhibitors, VRDN-006 and VRDN-008. FcRn inhibitors have the potential to treat a broad array of autoimmune diseases, representing a significant commercial market opportunity. Viridian’s multi-pronged engineering approach has resulted in a portfolio of FcRn-targeting molecules that leverage the clinically and commercially validated mechanism of FcRn inhibition while potentially addressing the limitations of current agents such as incomplete IgG suppression and needed improvements in safety.

VRDN-006 is a highly-selective Fc fragment. In non-human primates, VRDN-006 showed specificity for blocking FcRn-IgG interactions while showing no decreases in albumin or increases in low-density lipoprotein (LDL) levels. VRDN-008 is a novel, first-in-class FcRn inhibitor that aims to pair IgG suppression with extended half-life technology. VRDN-008, with its extended half-life, has the potential to more deeply and durably suppress IgG as compared to existing anti-FcRn therapies and pipeline candidates. VRDN-006 and VRDN-008 are both designed to be convenient, self-administered, subcutaneous products.

Summary of Anticipated 2024 Key Program Milestones

Thyroid eye disease (TED) Portfolio

 

   

Mid-2024

 

   

THRIVE Phase 3 trial topline results in active TED for VRDN-001 IV

 

   

Initiate subcutaneous pivotal program for VRDN-003, pending regulatory alignment

 

   

Year End 2024

 

   

THRIVE-2 Phase 3 trial topline results in chronic TED for VRDN-001 IV

Anti-FcRn Portfolio

 

   

2H 2024

 

   

IND submission for VRDN-006 by year end

 

   

VRDN-008 NHP data


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Corporate Updates

Today, the company announced the promotion of Dr. Thomas Ciulla to Chief Medical Officer to succeed Dr. Barrett Katz. Dr. Katz will continue to work with Viridian as a consultant to the company. Dr. Ciulla joined Viridian in early 2023 as Chief Development Officer, where he has been leading the clinical development efforts for all programs. Dr. Ciulla has held numerous leadership roles in medical and clinical development and research, including serving most recently as Chief Medical Officer and Chief Development officer of Clearside Bio prior to joining Viridian.

“Dr. Ciulla has been an integral part of the Viridian team throughout his tenure and will continue to lead our clinical development efforts as Chief Medical Officer,” said Mr. Mahoney. “We are grateful to Dr. Katz for his years of dedicated service to Viridian and look forward to working with him as an advisor to the company.”

Notice of Inducement Grant

Today Viridian announced that a majority of the independent directors serving on the Compensation Committee of the company’s Board of Directors approved the grant of non-qualified stock options to an employee to purchase up to 62,000 shares of the company’s common stock (the “Inducement Grant”) on January 2, 2024 (the “Grant Date”). The Inducement Grant has been granted outside of the company’s Amended and Restated 2016 Equity Incentive Plan (the “Plan”) but remains subject to the terms and conditions of such Plan. The Inducement Grant was granted as an inducement material to this individual entering into employment with Viridian in accordance with Nasdaq Listing Rule 5635(c)(4).

The Inducement Grant has an exercise price per share that is equal to the closing price of Viridian’s common stock on the Grant Date. The Inducement Grant will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s start date, and thereafter the remainder of the shares vest in 36 equal monthly installments, subject to the employee’s continued employment with Viridian through the applicable vesting dates.

About Viridian Therapeutics

Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting two global Phase 3 clinical trials (THRIVE and THRIVE-2) to evaluate the safety and efficacy of VRDN-001 in patients with active and chronic TED. Viridian’s goal is to advance VRDN-001 as a best-in-class IV therapy followed by VRDN-003 as a first- and best-in-class subcutaneous therapy for the treatment of TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit http://www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations,


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and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical and clinical development of Viridian’s product candidates VRDN-001, VRDN-003, VRDN-006 and VRDN-008; anticipated start dates of studies; alignment with regulatory authorities and anticipated regulatory submissions; enrollment in Viridian’s clinical studies, including the THRIVE and THRIVE-2 Phase 3 clinical studies; upcoming milestones and anticipated data results, including topline results; that THRIVE and THRIVE-2 data will look to confirm the Phase 2 data Viridian reported throughout 2022 and 2023; the potential utility, efficacy, potency, safety, clinical benefits, clinical response and convenience of VRDN-001, VRDN-003, VRDN-006 and VRDN-008; Viridian’s product candidates potentially being best-in-class; that because VRDN-001 and VRDN-003 are nearly identical antibodies, the company expects VRDN-003 to have similar clinical responses at the exposure levels of VRDN-001 that led to robust clinical activity in a Phase 2 clinical study in TED; that pharmacokinetic modeling of VRDN-003 predicts that dosing regimens as long as every 8 weeks would achieve or exceed the same VRDN-001 exposure levels that were clinically meaningful; the time to market and commercial viability of Viridian’s product candidates; and potential dosing schedules trial designs. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response and convenience of Viridian’s product candidates; the relationship between the results from the positive data from completed or ongoing clinical trials and the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, pre-clinical and clinical development programs; trial protocols for ongoing clinical trials; expectations regarding the timing for regulatory filings; expectations regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations; our financial position and its projected cash runway; our future operating results and financial performance; Viridian’s intellectual property position; the timing of pre-clinical and clinical trial activities and reporting results from same, including those risks set forth under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 13, 2023 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Contact:

Louisa Stone, 617-272-4604

Manager, Investor Relations

IR@viridiantherapeutics.com

Source: Viridian Therapeutics, Inc.

v3.23.4
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Jan. 03, 2024
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Entity Registrant Name Viridian Therapeutics, Inc.DE
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Entity Central Index Key 0001590750
Document Type 8-K
Document Period End Date Jan. 03, 2024
Entity Incorporation State Country Code DE
Entity File Number 001-36483
Entity Tax Identification Number 47-1187261
Entity Address, Address Line One 221 Crescent Street
Entity Address, Address Line Two Suite 401
Entity Address, City or Town Waltham
Entity Address, State or Province MA
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City Area Code (617)
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Security 12b Title Common Stock, $0.01 par value
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Entity Emerging Growth Company false

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