SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
May 6, 2021
Date of Report (Date of earliest event reported)
(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
|(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))|
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, par value $0.001 per share||CMRX||The Nasdaq Global 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. ¨
Item 2.02 Results of Operations and Financial Condition.
On May 6, 2021, we announced our financial results for the first quarter ended March 31, 2021 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 2.02 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 2.02 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.
|Item 9.01||Financial Statements and Exhibits.|
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: May 6, 2021|| || |
| || ||By:||/s/ Michael T. Andriole|
| || || ||Michael T. Andriole|
| || || ||Chief Business and Financial Officer|
Chimerix Reports First Quarter 2021 Financial Results and Provides Operational Update
– BCV PDUFA Date Set for July 7 and ONC201 Blinded Independent Central Review Expected in Second Half of 2021 –
– DSTAT COVID 19 Trial Advances to Cohort 3 at Higher Dose –
– Conference Call at 8:30 a.m. ET Today –
DURHAM, NC, May 6, 2021 -- 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 first quarter ended March 31, 2021 and provided an operational update.
“As we continue execution toward important milestones in the second half of this year, we are also positioning the company for the next phase of growth. This is highlighted by the recent appointment of Vicki Vakiener who brings extensive commercial and oncology experience to our Board of Directors,” said Mike Sherman, Chief Executive Officer of Chimerix.
“We look forward to our July 7th Prescription Drug User Fee Act (PDUFA) date for BCV as a medical countermeasure for smallpox. We responded to the Small Business Sources Sought Notice (SSN) issued in late March by Biomedical Advanced Research and Development Authority (BARDA), which is another formal step toward a potential procurement contract. We also remain on track to have the blinded independent central review for ONC201 in the second half of 2021. This response data, and other important measures of clinical benefit and safety, may form the basis for an NDA submission seeking accelerated approval of ONC201 for patients with H3 K27M-mutant glioma. In addition, we continue important development of DSTAT in both the Phase 3 DASH AML and Phase 2 COVID-19 trials,” continued Mr. Sherman.
BCV for Smallpox
In late March 2021, BARDA issued an SSN seeking information on availabilities and capabilities for procuring, stockpiling, and investing in the development of FDA-approved smallpox antiviral(s) with alternative mechanism(s) of action to TPOXX®. Chimerix responded to the SSN with information on our relevant capabilities, experience and interest. Chimerix remains on pace to deliver initial quantities of BCV under a potential stockpile agreement as early as a few months after FDA approval, if received.
DSTAT for Acute Lung Injury Patients with COVID-19
Chimerix today reported partial data from the second cohort of the ongoing Phase 2 study of DSTAT for COVID-19 patients, as the biomarker analysis is not yet available. In the second cohort, based on a switch to 2:1 randomization, eight patients were randomized to receive a 4mg/kg bolus dose of DSTAT followed by a continuous infusion of 0.325mg/kg/hour (as opposed to 0.25mg/kg/hr in cohort one), and four patients were randomized to receive placebo. The trial enrolled patients with either NIAID 3 (more severe at baseline) or NIAID 4 (less severe at baseline) disease. None of the patients treated with placebo entered the trial with the more severe disease while two DSTAT patients were identified with
more severe disease at baseline. One patient randomized to DSTAT required transfer to the ICU within 24 hours of admission, along with discontinuation of DSTAT due to prohibited concomitant medications and died after the day 28 endpoint. One patient randomized to placebo withdrew consent before treatment. All remaining seven patients receiving DSTAT and three patients receiving placebo recovered by day 28. As with the first cohort, the ability to gain insight into efficacy signals in this cohort is limited due to the small sample size and random demographic imbalances. Supportive biomarker analysis will be performed as those results are available. The Data Safety Monitoring Board recommended advancing to cohort three, which will include approximately 50 patients, at the higher cohort two dose.
DSTAT for AML
Chimerix recently began enrolling patients in the Phase 3 Dociparstat in AML with Standard Chemotherapy (DASH AML) study of DSTAT for the treatment of AML. The multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of DSTAT in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly-diagnosed AML patients. Chimerix expects to unblind data following enrollment of the first 80 evaluable patients in this study to assess complete response rates and minimal residual disease rates between the study arm and the control arm. This analysis is expected to take place in 2022.
Imipridones and ONC201
In January, Chimerix announced the acquisition of Oncoceutics, Inc., a privately-held, clinical-stage biotechnology company developing imipridones, a novel class of small molecule anti-cancer compounds. Oncoceutics’ lead product candidate, ONC201, has been shown in clinical testing to selectively induce cell death in multiple cancer types. Final analysis of results from the registration cohort of 50 patients in clinical trials for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected in the second half of this year.
In addition, Phase 1 clinical trials for ONC206, the second product candidate in Oncoceutics’ pipeline, were recently initiated and IND-enabling work for a third imipridone candidate, ONC212, is ongoing.
In January, Chimerix closed an underwritten public offering of 13.5 million shares of common stock. The net proceeds to Chimerix from the offering, after deducting underwriting discounts and commissions and other offering expenses, were $107.8 million.
In April 2021, Vicki Vakiener was appointed to the Company’s board of directors. Ms. Vakiener currently serves as Chief Commercial Officer of Epizyme, Inc., where she leads the company’s commercial efforts and has overseen the successful launch of tazemetostat in two indications. During her more than 20 years of experience in oncology, Ms. Vakiener has held positions of leadership across Johnson & Johnson’s pharmaceuticals and diagnostics businesses.
Expected 2021 Milestones
•FDA PDUFA action date set for July 7, 2021 for BCV smallpox NDA.
•Potential procurement agreement for BCV around the time of FDA decision on smallpox NDA, if favorable.
• Completion of Phase 2 trial of DSTAT in COVID-19 related ALI.
• Completion of BCV drug product manufacturing to support potential shipments to the SNS of up to $100 million.
• Blinded independent central review of 50-subject registration cohort of ONC201 in recurrent H3 K27M-mutant glioma.
First Quarter 2021 Financial Results
Chimerix reported a net loss of $97.4 million, or $1.21 per basic and diluted share, for the first quarter of 2021. During the same period in 2020, Chimerix recorded a net loss of $10.4 million, or $0.17 per basic and diluted share.
Revenues for the first quarter of 2021 increased to $1.4 million, compared to $1.2 million for the same period in 2020.
Research and development expenses increased to $11.9 million for the first quarter of 2021, compared to $8.9 million for the same period in 2020.
General and administrative expenses increased to $4.1 million for the first quarter of 2021, compared to $3.2 million for the same period in 2020.
Chimerix recorded acquired in-process research and development expenses of $82.9 million for the first quarter of 2021 related to the acquisition of Oncoceutics, Inc.
Loss from operations was $97.5 million for the first quarter of 2021, compared to a loss from operations of $10.9 million for the same period in 2020.
Chimerix's balance sheet at March 31, 2021 included $152.5 million of capital available to fund operations, $14.0 million in a note payable related to the Oncoceutics transaction, and approximately 86.2 million outstanding shares of common stock.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss first quarter 2021 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 5156727.
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.
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. Our three most advanced clinical-stage development programs are BCV, ONC201 and DSTAT. BCV is an antiviral drug candidate developed as a potential medical countermeasure for smallpox and is currently under review for regulatory approval in the United States. ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected later this year. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia and as a potential treatment for acute lung injury in hospitalized COVID-19 patients.
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 timing of the confirmatory response rate assessment for ONC201; the sufficiency of the data from the current Phase 2 clinical trial of ONC201 to support accelerated regulatory approval; the
anticipated benefits of Chimerix’s acquisition of Oncoceutics; the completion of a Phase 3 study in acute myeloid leukemia with DSTAT; Chimerix’s ability to obtain regulatory approval for its clinical candidates, including DSTAT, ONC201 and BCV; and Chimerix’s ability to enter into a procurement agreement for the sale of BCV to the SNS. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the current Phase 2 clinical trial data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of Oncoceutics may not be realized; BCV may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that Chimerix will not obtain a procurement contract for BCV in smallpox 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.
Stern Investor Relations
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| ||March 31, 2021||December 31, 2020|
|ASSETS|| || |
|Current assets:|| || |
|Cash and cash equivalents||$||32,080 ||$||46,989 |
|Short-term investments, available-for-sale||112,898 ||31,973 |
|Accounts receivable||482 ||340 |
|Prepaid expenses and other current assets||2,677 ||2,356 |
|Total current assets||148,137 ||81,658 |
|Long-term investments||7,548 ||— |
|Property and equipment, net of accumulated depreciation||218 ||214 |
|Operating lease right-of-use assets||2,717 ||2,825 |
|Other long-term assets||29 ||26 |
|Total assets||$||158,649 ||$||84,723 |
|LIABILITIES AND STOCKHOLDERS' EQUITY|| || |
|Current liabilities:|| || |
|Accounts payable||$||2,181 ||$||1,283 |
|Accrued liabilities||6,067 ||7,250 |
|Note payable||14,000 ||— |
|Total current liabilities||22,248 ||8,533 |
|Lease-related obligations||2,752 ||2,814 |
|Total liabilities||25,000 ||11,347 |
|Stockholders’ equity:|| || |
|Preferred stock, $0.001 par value, 10,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020||— ||— |
|Common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; 86,208,279 and 62,816,039 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively||86 ||63 |
|Additional paid-in capital||943,381 ||785,673 |
|Accumulated other comprehensive loss, net||(43)||— |
|Total stockholders’ equity||133,649 ||73,376 |
|Total liabilities and stockholders’ equity||$||158,649 ||$||84,723 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Three Months Ended March 31,|
|Contract and grant revenue||$||1,433 ||$||1,171 |
|Licensing revenue||2 ||70 |
|Total revenues||1,435 ||1,241 |
|Operating expenses:|| || |
|Research and development||11,862 ||8,949 |
|General and administrative||4,136 ||3,205 |
|Acquired in-process research and development||82,890 ||— |
|Total operating expenses||98,888 ||12,154 |
|Loss from operations||(97,453)||(10,913)|
|Interest income and other, net||38 ||493 |
|Other comprehensive loss:|| || |
|Unrealized loss on debt investments, net||(43)||(46)|
|Per share information:|| || |
|Net loss, basic and diluted||$||(1.21)||$||(0.17)|
|Weighted-average shares outstanding, basic and diluted||80,204,094 ||61,742,035 |