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
January 10, 2018
Date of Report (Date of earliest event reported)
Chimerix, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-35867 | 33-0903395 | ||
(State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) | ||
of incorporation) | ||||
2505 Meridian Parkway, Suite 100 Durham, NC | 27713 | |
(Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (919) 806-1074
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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)) | |
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 7.01 Regulation FD Disclosure.
Attached hereto as Exhibit 99.1 and incorporated herein by reference is a corporate update presentation to be utilized by Chimerix, Inc. at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, California.
The information in this Item 7.01 and the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 7.01 and the attached Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Forward-Looking Statements
Statements contained in, or incorporated by reference into, this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in our filings with the Securities and Exchange Commission, including without limitation our most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits |
Exhibit No. | Description | |
99.1 | ||
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.
Chimerix, Inc. | |||
Dated: January 10, 2018 | |||
By: | /s/ Timothy W. Trost | ||
Timothy W. Trost | |||
Senior Vice President, Chief Financial Officer and Corporate Secretary | |||
J.P. MORGAN HEALTHCARE CONFERENCE
M. MICHELLE BERREY, MD, MPH
PRESIDENT AND CEO
JANUARY 2018
2
Forward-Looking Statements
These slides and the accompanying oral presentation contain forward-looking statements and information
within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks,
uncertainties and other factors, including the possibility that there may not be a viable continued
development path for brincidofovir, that any clinical trials we may conduct will not demonstrate adequate
efficacy and safety of brincidofovir, that the FDA and other regulatory authorities may not approve
brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have
significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In
addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory
authorities. Similar risks and uncertainties apply to our development of CMX521. These risks, uncertainties
and other factors could cause actual results to differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks
are described in detail in Chimerix's Quarterly Report on Form 10-Q for the quarter ended September 30,
2017 and other documents subsequently filed with or furnished to the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information currently available to Chimerix, and
Chimerix assumes no obligation to update any such forward-looking statements.
3
Why Are We Excited About 2018?
AdAPT trial of short-course oral BCV for adenovirus enrolling and data
expected in 2019; if positive, data should support first regulatory approval
Lack of GI side-effects with multiple doses of IV BCV supports progression to
Phase 2 patient studies in 2018, leading to potential studies in prevention and
treatment of multiple viruses including AdV, CMV, and BKV in 2019
Regulatory submissions for marketing approval of oral BCV for smallpox are
planned for 2019
CMX521, the first direct-acting antiviral specific for norovirus, is now in clinical
stage development
We have patent protection through 2034 and sufficient capital to progress oral
BCV to value-generating data and/or procurement contracts
4
Data-Rich 2018 and 2019 Ahead of Regulatory Decisions
Oral BCV
Adenovirus
Enrolling AdAPT
AdVance Data
Enrolling AdAPT
Adult
AdAPT Data
Smallpox Pivotal mouse study
Pivotal mouse study
Supportive rabbit
study
MAA submission
NDA submission
IV BCV
Adenovirus
and CMV
Initiate Phase 2 in
patients
Phase 2 in patients Initiate MVP pivotal
trial
Compound Indication 1H 2018 2H 2018 2019
CMX521
Treatment of
Chronic
Norovirus Ph 1 single dose
study
Ph 1 multiple dose
study
Norovirus: Challenge
/ Proof-of-Concept
trial
Prevention of
Norovirus
Outbreaks
5
CMRX: Developing Solutions for Immunocompromised Patients
Experienced and committed management team with successful track records
developing significant antiviral drugs and first-in-indication commercial launches
Lead compound brincidofovir has broad-spectrum antiviral activity
– Short-course oral BCV in late-stage development for treatment of smallpox and adenovirus
– New IV BCV formulation for prevention of serious viral infections in transplant recipients
and treatment of viral diseases in the growing immunocompromised patient population
Proprietary lipid-conjugate technology has led to two clinical-stage compounds
– Brincidofovir (CMX001, BCV) and CMX157, licensed to ContraVir
CMX521: newest investigational compound for norovirus
– Developed from Chimerix Chemical Library
– First clinical dosing began in December 2017
6
Brincidofovir: Broad Spectrum Antiviral For dsDNA Viruses
Viral Family Virus BCV Cidofovir Maribavir Letermovir Ganciclovir* Foscarnet Acyclovir
Herpes
Cytomegalovirus 0.001 0.4 0.31 0.005 3.8 50-800 >200
Epstein-Barr Virus 0.03 65.6 0.63 >10 0.9 <500 6.2
Human Herpesvirus 6 0.003 2.7 Inactive >10 5.8 16 10
Human Herpesvirus 8 0.02 2.6 Inactive ― 8.9 177 >100
Herpes Simplex Virus 1 0.01 3.0 Inactive >10 0.7 92-95 3.8
Herpes Simplex Virus 2 0.02 6.5 Inactive >10 2.5 91-96 4.4
Varicella Zoster Virus 0.0004 0.5 Inactive >10 1.3 39.8 3.6
Adenovirus Adenovirus (AdV-B7) 0.02 1.3 ― >10 4.5-33 Inactive >100
Polyoma
BK Virus (BKV) 0.13 115 ― ― >200 Inactive >200
JC Virus (JCV) 0.045 >0.1 ― ― ― Inactive ―
Papilloma Human Papillomavirus 17 716 ― ― Inactive ― Inactive
Pox
Variola 0.1 27 ― ― ― ― ―
Vaccinia 0.8 46 ― ― >392 Inactive >144
Potency expressed as EC50 = concentration in µM required to reduce viral replication by 50% in vitro; “―” indicates no data.
*Valganciclovir is rapidly converted to ganciclovir in vivo; ganciclovir is the relevant compound for cell activity studies.
Source: Data are compiled from multiple sources and include multiple materials and methodologies.
7
AdAPT Now Enrolling – Data Expected in 2019
2017 2018 2019 2020
AdAPT
DATA
Oral BCV
for AdV
All timelines are estimated
AdAPT Adult
Study being conducted in US, UK and EU
Short-course oral treatment for acute life-threatening adenovirus infections
– Potent antiviral with high barrier to resistance
– Rapid reduction of AdV viral load in blood and other compartments
– Short-course treatment minimizes risk of side effects
Follow up Period
Potential Treatment Period
Potential Treatment Period
8
AdAPT: Adenovirus after Allogeneic Pediatric Transplantation
Open label, comparative study of oral BCV vs. standard of care (SoC) in AdV viremia
– Pediatric T-cell depleted allo-HCT recipients during first 100 days of HCT
Short-course therapy: “Treat-to-clear” paradigm
– BCV or SoC administered until AdV is cleared from plasma
Primary endpoint: AdV viral burden over 16 weeks
– Agreed by CHMP and FDA
Study size: N=141 to be randomized 2:1 to oral BCV or local standard of care
Oral BCV BIW
Standard of Care
n=94
16 8 Week
0
4 12
n=47
24 36
Follow up Period
9
Maximizing the Probability of Success for AdAPT
Study design incorporates key learnings for oral brincidofovir:
– Includes highest risk patients: pediatric recipients of T-cell depleted HCT prior to immune
reconstitution
– Short-course oral BCV therapy begun within the first three weeks of adenoviremia
• Rapidly clears virus
• Minimizes side effects
– Primary endpoint is AdV burden over time, the most sensitive measure to differentiate the
antiviral effect of oral BCV from SoC
– >90% power to show superiority of brincidofovir to local SoC
– Open-label study – randomized but not blinded
Study sites are experienced with BCV, prospectively monitor for AdV and
have expertise in treating AdV infections in high-risk patient populations
Rapid Antiviral Effect of Oral Brincidofovir vs Local SOC*
Oral BCV
from AdVise
3 yr old pt
41 days post-TCD
HCT
Local Standard of
Care (SoC) from
AdVance
2 yr old pt
19 days post-HCT
21 mo, Campath, 19d post HCT
4 2 8 12 0 16
WEEK
-4 0
-4
4 2 8 12 16
WEEK
Detection of AdV in the blood
after transplant predicts rapid
progression to AdV disease
and death in high-risk
transplant recipients
Oral BCV has demonstrated
rapid clearance of AdV viremia
BCV does not require immune
reconstitution to provide viral
load reductions
Average Viral Load =
4.40 log10 copies/mL
†
Average Viral Load =
2.03 log10 copies/mL
†
*Local standard-of-care may include reduction of
immunosuppressants or off-label IV cidofovir
† Lower limit of detection: 2 log copied/mL
10
11
Regulatory Acceptance of AdV Viral Load as a Surrogate
Endpoint for Pivotal Studies
AdAPT was designed with European regulators; positive data should support full or
conditional approval
FDA has recently announced CMV viremia as an acceptable surrogate endpoint for pivotal
CMV studies; viremia without statistically significant mortality sets an important precedent for
anticipated discussions on results from AdAPT
We are working with international experts to build similar substantial evidence in support of
AdV viral load as an acceptable surrogate endpoint for pivotal studies
– European Group for Blood and Marrow Transplant (EBMT) plans to publish ID Working Group
position paper with state-of-the-art screening and treatment recommendations for the diagnosis
and treatment of adenovirus after HCT
– AdVance: multiple abstracts planned for EBMT March 2018 that demonstrate the correlation of
AdV viral burden with risk of mortality
– Multiple independent analyses from transplant centers across Europe and the US show a strong
correlation of AdV viral load, disease and mortality
Early development work shows great promise for the IV formulation
12
IV BCV: Fulfilling the Potential of Brincidofovir
IV BCV delivers uniform exposure
to key organs
IV BCV delivers more drug to
difficult-to-reach compartments,
especially the brain
IV BCV profile may allow for both
treatment and prevention of DNA
viral infection
Does not over-expose gut which should
allow for long-term tolerability
Supports evaluation of IV BCV for viral
brain infections, such as HHV6
encephalitis or JC virus
Potential for once-weekly dosing and
improved tolerability could allow for
broader use in multiple viruses
13
IV BCV: Multiple-Ascending Dose Study Demonstrates Improved
GI Tolerability
Multiple Ascending Dose (MAD) Study Design:
– IV BCV 10 mg twice-weekly (BIW), 20 mg once-weekly (QW) for 4 doses
– No dose-limiting clinical adverse events
– No diarrhea with IV BCV 10 mg twice-weekly
• IV BCV 10 mg provided plasma drug levels equivalent to oral BCV 100 mg
which demonstrated antiviral activity in prior studies
Phase 2 IV BCV patient studies starting in 1H 2018
– Demonstrate PK and tolerability of multiple doses in adult HCT recipients
– Evaluate relationship between dose and change-from-baseline in AdV in blood and stool
– Data expected 2H 2018 to inform dose & dosing regimen for MVP-Peds study of multi-
viral prevention
Multiviral Protection in Peds
and Adult Allo-HCT
BKV Treatment in Allo-HCT and SOT
Other Uses of IV BCV in DNA Viral Infections
14
Building Full Potential Value for Oral and IV Brincidofovir –
“Land and Expand”
Pediatric & Adult Allo-HCT Recipients Treatment
Pediatric & Adult Auto HCT and SOT Recipients Treatment
Immunocompromised AdV Patients Treatment
“Other” AdV Patients Treatment
AdV
EXPAND
Via Lifecycle
Management &
Clinical Development
LAND
Pediatric & Adult Allo-HCT Recipients
Prevention
Pediatric & Adult Allo-HCT
and SOT Recipients Treatment
TBD
15
Anticipated Brincidofovir Milestones and Regulatory Decisions
Phase 2 IV BCV data to support dose-selection for MVP pivotal trial
IV BCV offers the promise of longer term dosing with improved tolerability
2017 2018 2022
MVP DATA
2019 2020
IV BCV for
Multi-Viral
Prevention
IV BCV
SAD
IV BCV
MAD IV BCV Ph 2
in adult HCT
with AdV
All timelines are estimated
2021
AdAPT DATA
Oral BCV
for AdV
16
Brincidofovir: Oral Antiviral With Demonstrated Activity
Against Smallpox
Oral BCV has demonstrated survival benefit in two animal models of fatal
orthopoxvirus infections:
Rabbitpox virus model replicates human smallpox pathophysiology: asymptomatic
infection, illness, and death
– 100% survival demonstrated in animals that received immediate treatment with
brincidofovir
– Delayed treatment in 24 or 48 hrs resulted 93% survival
Mouse pox infection (ectromelia) replicates the respiratory infection route of human
smallpox infection
– Pivotal study to be conducted in 2018
Smallpox: Highest Bioweapon Threat
17
“The next epidemic could originate on the computer screen of a terrorist intent on using
genetic engineering to create a synthetic version of the smallpox virus...”
- Bill Gates, Munich, April 2017
UN Bioweapons Conference Confirms Global Concern
Chimerix sponsored a smallpox
symposium in December 2017
at UN Biological Weapons
Convention in Geneva
– Threats from synthetic biology,
undeclared smallpox stockpiles
– Role of antivirals as medical
countermeasures
Interest level exceeded
expectations
– Over 100 government agency
attachés attended
18
19
Expedited EU Submission Supported for Brincidofovir
EMA marketing approval generally precedes procurement discussions in EU
– Marketing Approval in EU can be cross-referenced for international procurement
contracts outside the EU
Formal Scientific Advice was requested from the CHMP regarding required
elements for a European marketing application for smallpox
– Animal Efficacy Studies conducted for brincidofovir include a pivotal rabbitpox
study which demonstrated 100% survival in animals treated at the time of
confirmed infection compared with <50% survival in placebo animals (p<0.001)
– Application would include data from over 50 studies in the supportive mousepox
efficacy model
EMA responded that data from completed studies are sufficient for MAA
submission: preparations are underway
20
Second Animal Model of Orthopoxvirus for US Submission
2017 2018 2019 2020
Oral BCV
for smallpox
Mouse Efficacy
Study
All timelines are estimated
DATA
Supportive
Rabbit
Study
Plan to initiate pivotal mouse study and supportive rabbit study in 2018
Data could support filing in US for smallpox in 2019
CMX521: The First Specific Antiviral for Norovirus
As a nucleoside selected from the Chimerix Chemical Library, CMX521:
– targets the polymerase, an enzyme essential for viral replication
– targets a portion of the virus that remains consistent across diverse strains
– has demonstrated in vitro antiviral activity against all norovirus genotypes tested
First subject was dosed in December 2017, data anticipated in 2018
– Intestinal biopsies will determine intracellular drug levels for the target cells
– Drug levels in intestinal cells that achieve effective in vitro concentrations could de-risk
program
~700 million cases of norovirus each year
Tremendous economic toll: >$60 billion/yr
21
22
Treatment Target is the Gut Epithelia
Norovirus replicates in epithelium of the gut
May need to target only cells
represented by yellow highlight
Without
CMX521
CMX521
3 hrs before
virus
CMX521 at
time of
virus
In vitro, efficacious levels of active antiviral reached at 2-4 hours after drug exposure
Active antiviral half-life is 24 hours: suggests once-daily dosing
CMX521 Decreases
Norovirus >90% in vitro
Two Distinct Norovirus Opportunities
Treatment of Chronic Norovirus
– Increasingly recognized in
immunocompromised patients:
• Stem cell transplant recipients
• Solid organ transplant recipients
• Other immunocompromised patients
including those on biologics
– Asymptomatic shedders who increase
public health risks
• Food handlers, healthcare workers
Prevention of Norovirus Outbreaks
– At-risk individuals who have been
exposed to a confirmed case of
norovirus
– Individuals who may be at risk due to a
local outbreak without confirmed
exposure
– Individuals who elect to or need to be
protected from a potential outbreak
23
24
CMRX: Building A Pipeline of Solutions for Patients at Risk of
Serious Viral Infections
2017 2018 2021
MVP / pivotal DATA
2019 2020
IV BCV for
Multi-Viral
Prevention
2022
AdAPT DATA
Oral BCV
for AdV
CMX521
SAD/MAD
CMX521
POC
CMX521 Treatment
of Norovirus
CMX521 Prevention
of Norovirus
Outbreaks
DATA
CMX521 for
Norovirus
Oral BCV
for smallpox
Mouse Efficacy
Study
DATA
AdAPT Adult
IV BCV Ph 2 in
adult HCT with
AdV
25
CMRX: Four Active Clinical Programs in 2018
Program Indication Pre-clinical Phase 1 Phase 2 Phase 3 Status
Anticipated
Approval
Short-course
Oral BCV
AdV Treatment
AdAPT
enrolling 2021
Smallpox
Animal Rule
models
progressing
2020
IV BCV
Multi-viral
Prevention
Ph 2 in
patients
2018
2022
CMX521 Norovirus
SAD/MAD in
2018
2023
Chimerix remains well-capitalized with $241M at the end of 3Q 2017
Patent protection into 2034 for brincidofovir, and 2036 for CMX521