GlobeNewswire Inc | Aug 10, 2020 07:00AM EDT

August 10, 2020

Completion of BCV NDA Rolling Submission Planned for Third Quarter 2020

Currently Enrolling Phase 2/3 Study of DSTAT in Patients with COVID-19;Phase 2 Enrollment Completion Expected in Fourth Quarter

Startup Activities for DSTAT Phase 3 AML Study Initiated;Site Activation Expected Early 2021

Conference Call at8:30 a.m. ETToday

DURHAM, N.C., Aug. 10, 2020 (GLOBE NEWSWIRE) -- 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. DSTATs 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) inpatients 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 millionin 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 Chimerixs website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.

AboutChimerix

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-, monocyte chemoattractant protein-1 (MCP-1) and macrophage inflammatory protein-1 (MIP-1), 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; Chimerixs 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; Chimerixs 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; Chimerixs 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 theSecurities 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 919 972-7115ir@chimerix.com

Will OConnor Stern Investor Relations212-362-1200will@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 338 540 depreciationOperating 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, 62 62 respectively 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? $ 101,673 $ 119,376 equity

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 8,578 13,827 17,527 27,342 development General and 3,110 6,312 6,315 13,998 administrative Total operating 11,688 20,139 23,842 41,340 expenses Loss from (10,286 ) (18,701 ) (21,199 ) (37,546 ) operationsOther income: Interest income and 270 1,051 763 2,203 other, net Net loss (10,016 ) (17,650 ) (20,436 ) (35,343 ) Other comprehensive loss: Unrealized gain on 141 77 95 217 debt investments, net Comprehensive $ (9,875 ) $ (17,573 ) $ (20,341 ) $ (35,126 ) lossPer share information: Net loss, basic and $ (0.16 ) $ (0.35 ) $ (0.33 ) $ (0.69 ) diluted Weighted-average shares outstanding, basic and 62,042,778 51,130,104 61,892,407 51,009,935 diluted