Chimerix Reports Second Quarter 2020 Financial Results and Provides Operational Update
August 10 2020 - 7:00AM
Chimerix (NASDAQ: CMRX), a biopharmaceutical company focused
on accelerating the development of medicines to treat cancer and
other serious diseases, today reported financial results for the
second quarter ended June 30, 2020 and provided an operational
update.
Mike Sherman, Chief Executive Officer of Chimerix, commented,
“Our enthusiasm for the potential of dociparstat sodium (DSTAT) to
treat COVID-19 patients continues to grow as new data emerges on
the role of high mobility group box 1 (HMGB1) which has recently
been correlated with disease severity and survival. DSTAT’s
key targets include both HMGB1 and platelet factor 4 (PF4).
Inhibition of HMGB1 and PF4 with DSTAT could substantially address
the excessive inflammation and coagulation disorders observed in
these patients. We are currently enrolling our Phase 2/3 study of
DSTAT as a treatment for acute lung injury (ALI) in patients
with COVID-19 and expect to complete Phase 2 enrollment in the
fourth quarter of 2020. We have also resumed work on our DSTAT
program for the treatment of acute myeloid leukemia (AML) and now
expect site activation for the Phase 3 study to begin in early
2021.”
Mr. Sherman continued, “With the recent additions of Dr. Allen
Melemed as Chief Medical Officer and Caryn Barnett as Vice
President of Clinical Operations, we have continued to enhance our
strong leadership team. Both executives bring decades of successful
drug development expertise to Chimerix as we advance our
pipeline.”
“Importantly, we are in the midst of our rolling submission of
the New Drug Application (NDA) for the approval of brincidofovir
(BCV) as a medical countermeasure for smallpox and expect to
complete it by the end of the third quarter. The COVID-19 pandemic
has highlighted the importance of preparedness to treat future
viral outbreaks, especially those as deadly as smallpox, and we
look forward to a possible BCV regulatory approval and a potential
procurement contract for the U.S. Strategic National Stockpile
(SNS),” concluded Mr. Sherman.
Recent Highlights
- Began rolling NDA submission for the approval of BCV as a
medical countermeasure for smallpox
- Initiated enrollment in Phase 2/3 trial of DSTAT in ALI
patients with COVID-19
Expected Upcoming Milestones
- Completion of NDA submission of BCV in third quarter 2020
- Completion of enrollment of Phase 2 portion of DSTAT trial in
COVID-19 in fourth quarter of 2020
- Initiate Phase 3 AML trial in early 2021
- Potential procurement agreement for BCV prior to FDA decision
on smallpox NDA
- FDA decision on BCV smallpox NDA in 2021
- Completion of BCV drug product manufacturing to support a
potential shipment to the SNS of up to $100 million in
2021
Second Quarter 2020 Financial Results
Chimerix reported a net loss of $10.0 million, or $0.16 per
basic and diluted share, for the second quarter of 2020.
During the same period in 2019, Chimerix recorded a net loss of
$17.7 million, or $0.35 per basic and diluted share.
Revenues for the second quarter of 2020 were $1.4 million, equal
to the same period of 2019.
Research and development expenses decreased to $8.6 million for
the second quarter of 2020, compared to $13.8 million for the same
period in 2019.
General and administrative expenses decreased to $3.1 million
for the second quarter of 2020, compared to $6.3 million for the
same period in 2019.
Loss from operations was $10.3 million for the second quarter of
2020, compared to a loss from operations of $18.7 million for the
same period in 2019.
Chimerix's balance sheet at June 30, 2020, included $96 million
of capital available to fund operations, no debt and approximately
62.2 million outstanding shares of common stock. The Company
reaffirms its previous cash balance forecast of approximately $70
million at the end of 2020.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss second quarter 2020 financial results and provide a
business update today at 8:30 a.m. ET. To access the live
conference call, please dial 877-354-4056 (domestic) or
678-809-1043 (international) at least five minutes prior to the
start time and refer to conference ID 3334648.
A live audio webcast of the call will also be available on the
Investors section of Chimerix’s website, www.chimerix.com. An
archived webcast will be available on the Chimerix website
approximately two hours after the event.
About Chimerix
Chimerix is a development-stage biopharmaceutical company
dedicated to accelerating the advancement of innovative medicines
that make a meaningful impact in the lives of patients living with
cancer and other serious diseases. Its two clinical-stage drug
candidates are dociparstat sodium (DSTAT) and brincidofovir
(BCV).
DSTAT is a potential first-in-class glycosaminoglycan compound
derived from porcine heparin that, compared to commercially
available forms of heparin, may be dosed at higher levels without
associated bleeding-related complications. DSTAT is being
studied in a Phase 2/3 trial to assess safety and efficacy in
adults with acute lung injury with underlying COVID-19.
Inhibition of HMGB1 may be a primary anti-inflammatory target for
DSTAT. HMGB1 induces downstream proinflammatory cytokines,
including but not limited to, IL-6, TNF-α, monocyte chemoattractant
protein-1 (MCP-1) and macrophage inflammatory protein-1α (MIP-1α),
all of which are elevated in COVID-19. DSTAT also binds to
and inhibits the activity of PF4 which appears to play a
significant role in the coagulation disorders observed in severe
COVID-19.
A Phase 3 trial protocol to study DSTAT in acute myeloid
leukemia has been agreed to with the US Food and Drug
Administration (FDA) and site activation is expected in early
2021. BCV is an antiviral drug candidate in development as a
medical countermeasure for smallpox. For further information,
please visit the Chimerix website, www.chimerix.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Forward-looking
statements include those relating to, among other things, the
mechanism of action of DSTAT and its potential in ALI patients with
COVID-19; Chimerix’s ability to develop DSTAT, including the
ongoing Phase 2/3 clinical trial for DSTAT as a potential treatment
for ALI associated with COVID-19, and the site activation of the
Phase 3 clinical trial for DSTAT for the treatment of AML;
Chimerix’s ability to submit and/or obtain regulatory approvals for
DSTAT and BCV; and the timing and receipt of a potential
procurement contract for BCV in smallpox. Among the factors and
risks that could cause actual results to differ materially from
those indicated in the forward-looking statements are risks that
DSTAT may not achieve the endpoints in its clinical trials;
risks that DSTAT and BCV may not obtain regulatory approval from
the FDA or such approval may be delayed or conditioned; risks that
development activities related to DSTAT may not be completed on
time or at all; risks associated with entering in to a
procurement agreement for BCV on expected terms in a timely
manner or at all; Chimerix’s reliance on a sole source third-party
manufacturer for drug supply; risks that ongoing or future trials
may not be successful or replicate previous trial results, or may
not be predictive of real-world results or of results in subsequent
trials; risks and uncertainties relating to competitive products
and technological changes that may limit demand for our drugs;
risks that our drugs may be precluded from commercialization by the
proprietary rights of third parties; and additional risks set forth
in the Company's filings with the Securities and Exchange
Commission. These forward-looking statements represent the
Company's judgment as of the date of this release. The Company
disclaims, however, any intent or obligation to update these
forward-looking statements.
CONTACT:Investor Relations: Michelle LaSpaluto
919 972-7115 ir@chimerix.com
Will O’Connor Stern Investor Relations212-362-1200
will@sternir.com
Media:David SchullRusso
Partners858-717-2310David.Schull@russopartnersllc.com
CHIMERIX,
INC. |
|
CONSOLIDATED
BALANCE SHEETS |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
53,501 |
|
|
$ |
16,901 |
|
|
|
Short-term investments, available-for-sale |
|
|
42,449 |
|
|
|
96,574 |
|
|
|
Accounts receivable |
|
|
367 |
|
|
|
1,233 |
|
|
|
Prepaid expenses and other current assets |
|
|
2,578 |
|
|
|
3,385 |
|
|
|
|
Total current assets |
|
|
98,895 |
|
|
|
118,093 |
|
|
Property and equipment, net of accumulated depreciation |
|
|
338 |
|
|
|
540 |
|
|
Operating lease right-of-use assets |
|
|
2,414 |
|
|
|
709 |
|
|
Other long-term assets |
|
|
26 |
|
|
|
34 |
|
|
|
|
|
Total
assets |
|
$ |
101,673 |
|
|
$ |
119,376 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,425 |
|
|
$ |
2,398 |
|
|
|
Accrued liabilities |
|
|
4,811 |
|
|
|
6,830 |
|
|
|
|
Total current liabilities |
|
|
6,236 |
|
|
|
9,228 |
|
|
Lease-related obligations |
|
|
2,302 |
|
|
|
196 |
|
|
|
|
|
Total
liabilities |
|
|
8,538 |
|
|
|
9,424 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
June 30, 2020 and |
|
|
|
|
|
|
|
December 31, 2019; no shares issued and outstanding as of June 30,
2020 and |
|
|
|
|
|
|
|
December 31, 2019; |
|
|
— |
|
|
|
— |
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
June 30, 2020 and |
|
|
|
|
|
|
December 31, 2019; 62,172,418 and 61,590,013 shares issued and
outstanding as of |
|
|
|
|
|
|
June 30, 2020 and December 31, 2019, respectively |
|
|
62 |
|
|
|
62 |
|
|
|
Additional paid-in capital |
|
|
782,217 |
|
|
|
778,693 |
|
|
|
Accumulated other comprehensive gain, net |
|
|
130 |
|
|
|
35 |
|
|
|
Accumulated deficit |
|
|
(689,274 |
) |
|
|
(668,838 |
) |
|
|
|
Total stockholders’ equity |
|
|
93,135 |
|
|
|
109,952 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
101,673 |
|
|
$ |
119,376 |
|
|
|
|
|
|
|
|
|
|
|
CHIMERIX,
INC. |
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
Contract revenue |
|
$ |
1,396 |
|
|
$ |
1,438 |
|
|
$ |
2,567 |
|
|
$ |
3,794 |
|
|
|
Licensing revenue |
|
|
6 |
|
|
|
- |
|
|
|
76 |
|
|
|
- |
|
|
|
|
Total revenues |
|
|
1,402 |
|
|
|
1,438 |
|
|
|
2,643 |
|
|
|
3,794 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,578 |
|
|
|
13,827 |
|
|
|
17,527 |
|
|
|
27,342 |
|
|
|
General and administrative |
|
|
3,110 |
|
|
|
6,312 |
|
|
|
6,315 |
|
|
|
13,998 |
|
|
|
|
Total operating expenses |
|
|
11,688 |
|
|
|
20,139 |
|
|
|
23,842 |
|
|
|
41,340 |
|
|
|
|
|
Loss from operations |
|
|
(10,286 |
) |
|
|
(18,701 |
) |
|
|
(21,199 |
) |
|
|
(37,546 |
) |
|
Other income: |
|
|
|
|
|
|
|
|
|
|
Interest income and other, net |
|
|
270 |
|
|
|
1,051 |
|
|
|
763 |
|
|
|
2,203 |
|
|
|
|
|
|
Net
loss |
|
|
(10,016 |
) |
|
|
(17,650 |
) |
|
|
(20,436 |
) |
|
|
(35,343 |
) |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Unrealized gain on debt investments, net |
|
|
141 |
|
|
|
77 |
|
|
|
95 |
|
|
|
217 |
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(9,875 |
) |
|
$ |
(17,573 |
) |
|
$ |
(20,341 |
) |
|
$ |
(35,126 |
) |
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
Net loss, basic and diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.69 |
) |
|
|
Weighted-average shares outstanding, basic and diluted |
|
62,042,778 |
|
|
|
51,130,104 |
|
|
|
61,892,407 |
|
|
|
51,009,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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