NextCure Reports Third Quarter 2019 Financial Results
“NextCure has made important clinical and operational progress toward realizing our long-term vision of developing novel immunomedicines for patients who do not respond to standard treatments or existing immunotherapies,” said
- Presented clinical data from the Phase 1 portion of the NC318 Phase 1/2 Clinical Trial at the 34th Annual Meeting of
- Initiated the Phase 2 portion of the ongoing Phase 1/2 clinical trial of NC318.
Timothy Mayer, Ph.D. to Chief Operating Officer.
- Continued research activities under our collaboration agreement with
Eli Lilly and Company(“Lilly”).
- Remain on track to submit an investigational new drug application to the
U.S. Food and Drug Administrationfor our second product candidate, NC410, in the first quarter of 2020. NC410 is a novel immunomedicine designed to block immune suppression mediated by an immune modulator called Leukocyte‑Associated Immunoglobulin‑like Receptor 1, or LAIR‑1.
Financial Results for Quarter Ended
- Cash, cash equivalents, and marketable securities as of
September 30, 2019were $184.1 million, compared to $135.2 millionas of December 31, 2018. This increase primarily reflects net proceeds from our IPO of $77.0 million, partially offset by cash used to fund operations of $25.6 million.
- Revenue was
$1.6 millionand $4.3 millionfor the three and nine months ended September 30, 2019, respectively. We had no revenue in 2018. Revenue to date has been generated from the Lilly agreement.
- Research and development expenses were
$8.7 millionand $22.8 millionfor the three and nine months ended September 30, 2019, respectively, as compared to $4.9 millionand $13.5 millionfor the three and nine months ended September 30, 2018, respectively. The increases primarily reflect an increase in headcount, NC318 clinical research costs, lab supplies and services for NC318 and our other early stage programs and discovery activities, as well as a one-time license payment in connection with our IPO in the quarter ended June 30, 2019.
- General and administrative expenses were
$2.6 millionand $7.0 millionfor the three and nine months ended September 30, 2019, respectively as compared to $0.9 millionand $2.6 millionfor the three and nine months ended September 30, 2018, respectively. The increase was primarily related to increases in professional fees and insurance costs in connection with becoming a publicly traded company, as well as increases in personnel-related costs and an unrestricted gift to an academic lab in the prior quarter.
- Net loss was
$8.4 millionand $22.8 millionfor the three and nine months ended September 30, 2019, respectively, as compared to $5.7 millionand $15.9 millionfor the three and nine months ended September 30, 2018, respectively.
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15.
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity.
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share amounts)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Revenue from research and development arrangement||$||1,583||$||—||$||4,342||$||—|
|Research and development||8,663||4,895||22,819||13,539|
|General and administrative||2,622||925||6,995||2,590|
|Total operating expenses||11,285||5,820||29,814||16,129|
|Loss from operations||(9,702||)||(5,820||)||(25,472||)||(16,129||)|
|Other income, net||1,268||110||2,662||192|
|Net loss per common share—basic and diluted||$||(0.37||)||$||(4.17||)||$||(1.81||)||$||(11.64||)|
|Weighted average number of common shares —basic and diluted||22,715,567||1,369,212||12,609,219||1,369,212|
|Unrealized loss on marketable securities||(58||)||—||(58||)||—|
|Total comprehensive loss||$||(8,492||)||$||(5,710||)||$||(22,868||)||$||(15,937||)|
CONDENSED BALANCE SHEETS
(unaudited, in thousands, except share and per share amounts)
|September 30,||December 31,|
|Cash and cash equivalents||$||9,935||$||135,173|
|Prepaid expenses and other current assets||3,777||152|
|Total current assets||189,148||135,785|
|Property and equipment, net||12,031||11,407|
|Liabilities, Preferred Stock and Stockholders’ Equity (Deficit)|
|Deferred rent, current portion||—||28|
|Term loan, current portion||1,250||387|
|Deferred revenue, current portion||6,199||4,989|
|Total current liabilities||12,607||10,298|
|Deferred rent, net of current portion||434||242|
|Term loan, net of current portion||3,750||73|
|Deferred revenue, net of current portion||17,684||21,736|
|Commitments and contingencies|
|Redeemable preferred stock:|
|Series A Preferred Stock, par value of $0.001 per share; 0 and 68,181,819 shares authorized, issued and outstanding at September 30, 2019 and December 31, 2018, respectively||—||71,000|
|Series B Preferred Stock, par value $0.001 per share; 0 and 56,828,852 shares authorized at September 30, 2019 and December 31, 2018, respectively, 0 and 56,828,851 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||—||91,223|
|Total redeemable preferred stock||—||162,223|
|Stockholders’ equity (deficit):|
|Preferred stock, par value of $0.001 per share; 10,000,000 and 0 shares authorized at September 30, 2019 and December 31, 2018. No shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||—||—|
|Common stock, par value of $0.001 per share; 100,000,000 and 158,745,671 shares authorized at September 30, 2019 and December 31, 2018, respectively, 22,739,345, and 1,374,812 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively||23||1|
|Additional paid-in capital||240,791||352|
|Accumulated other comprehensive loss||(58)||—|
|Total stockholders’ equity (deficit)||170,649||(46,944)|
|Total liabilities, preferred stock and stockholders’ equity (deficit)||$||205,124||$||147,628|
Timothy Mayer, Ph.D. NextCure, Inc.Chief Operating Officer (240) 762-6486 IR@nextcure.com Media Inquiries Shai Biran, Ph.D. MacDougall (781) 235-3060 NextCure@macbiocom.com