NextCure Reports Second Quarter 2020 Financial Results
“Despite our recent announcement that we did not see sufficient clinical activity required for advancement in our initial non-small cell lung cancer and ovarian cancer Phase 2 cohorts, we remain encouraged about the NC318 single agent activity we have seen in patients with both non-small cell lung and head and neck cancers. We are working diligently in hopes of better understanding Siglec-15 biology and evaluating biomarkers that may provide a focused path forward. We anticipate having more information by the end of this year,” said Michael Richman, NextCure’s president and chief executive officer. “We recently initiated the Phase 1 portion of a Phase 1/2 clinical trial of NC410, our second product candidate, and expect to have initial clinical data for that trial in the second half of 2021. We remain highly committed to our goal of bringing novel immunomedicines to patients and remain focused on advancing our current clinical and preclinical programs.”
Business Highlights and upcoming milestones
- Observed one confirmed partial response in head and neck squamous cell carcinoma (HNSCC), and advanced this indication to the stage 2 portion of the Simon 2-stage trial of NC318.
- Continued enrolling new patients in the HNSCC and triple-negative breast cancer cohorts of the NC318 monotherapy trial.
- Reported initial biomarker data from the Phase 1 portion of the NC318 Phase 1/2 monotherapy clinical trial at the virtual
American Society of Clinical OncologyAnnual Meeting.
- Initiated the Phase 1 portion of a Phase 1/2 clinical trial for NC410.
Financial Results for Quarter Ended
- Cash, cash equivalents and marketable securities as of
June 30, 2020were $309.3 million, compared to $334.6 millionas of December 31, 2019. The decrease of $25.3 millionprimarily reflects cash used to fund operations of $23.0 millionand cash used to purchase fixed assets of $4.3 million.
- Research and development expenses were
$11.1 millionfor the quarter ended June 30, 2020, as compared to $7.6 millionfor the quarter ended June 30, 2019. The increases primarily reflect an increase in headcount, clinical research costs for NC318 and NC410, and expenses for lab supplies and services for NC318, NC410, our other early stage programs and discovery activities.
- General and administrative expenses were
$4.7 millionfor the quarter ended June 30, 2020, as compared to $2.7 millionfor the quarter ended June 30, 2019. The increase was primarily related to increases in personnel-related costs due to an increase in headcount, as well as increases in professional fees and insurance costs in connection with becoming a publicly traded company.
- There was no revenue recognized in the quarter ended
June 30, 2020as compared to $1.4 millionin the quarter ended June 30, 2019. Revenue generated in the prior year quarter was from our former research and development agreement with Eli Lilly.
- Net loss was
$14.5 millionfor the quarter ended June 30, 2020, as compared to $8.2 millionfor the quarter ended June 30, 2019. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount.
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15.
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and dendritic cell activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and dendritic cell activity.
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share amounts)
|Three Months Ended||Six Months Ended|
|Revenue from research and development arrangement||$||—||$||1,402||$||22,378||$||2,759|
|Research and development||11,130||7,643||21,708||14,156|
|General and administrative||4,671||2,714||8,259||4,373|
|Total operating expenses||15,801||10,357||29,967||18,529|
|Loss from operations||(15,801||)||(8,955||)||(7,589||)||(15,770||)|
|Other income, net||1,293||734||2,814||1,394|
|Loss per share:|
|Net loss per common share—basic and diluted||$||(0.53||)||$||(0.61||)||$||(0.17||)||$||(1.92||)|
|Weighted average number of common shares—basic and diluted||27,518,129||13,498,393||27,512,528||7,472,298|
|Unrealized gain on marketable securities||2,478||—||1,935||—|
|Total comprehensive loss||$||(12,030||)||$||(8,221||)||$||(2,840||)||$||(14,376||)|
CONDENSED BALANCE SHEETS
(unaudited, in thousands, except share and per share amounts)
|Cash and cash equivalents||$||25,050||$||34,091|
|Prepaid expenses and other current assets||4,029||3,684|
|Total current assets||315,070||339,995|
|Property and equipment, net||14,831||12,090|
|Liabilities, Preferred Stock and Stockholders’ Equity|
|Deferred rent, current portion||142||215|
|Term loan, current portion||1,667||1,667|
|Deferred revenue, current portion||—||6,428|
|Total current liabilities||8,362||15,042|
|Deferred rent, net of current portion||571||359|
|Term loan, net of current portion||2,639||3,333|
|Deferred revenue, net of current portion||—||15,950|
|Preferred stock, par value of
|Common stock, par value of
|Additional paid-in capital||405,763||402,529|
|Accumulated other comprehensive income (loss)||1,935||(38||)|
|Total stockholders’ equity||321,917||321,484|
|Total liabilities, preferred stock and stockholders’ equity||$||333,489||$||356,168|
Timothy Mayer, Ph.D. NextCure, Inc.Chief Operating Officer (240) 762-6486 [email protected] Media Inquiries Shai Biran, Ph.D. MacDougall (781) 235-3060 [email protected]