Neoleukin Therapeutics Announces Second Quarter 2020 Financial Results & Provides Corporate Update
Neoleukin Therapeutics (NASDAQ: NLTX) reported a net loss of $9.7 million for Q2 2020 compared to breakeven in Q2 2019, largely due to increased R&D expenses related to its lead candidate NL-201. The company completed a follow-on offering raising $71.4 million to support its clinical plans. NL-201, an IL-2 and IL-15 agonist, is set for IND submission in Q4 2020. Preclinical data shows NL-201 effectively stimulates cancer-fighting cells, with potential benefits across various cancers. Neoleukin's cash position stood at $129.6 million as of June 30, 2020, expected to fund operations through 2023.
- Raised $71.4 million from a follow-on offering.
- Anticipation of IND submission for NL-201 in Q4 2020.
- Promising preclinical data showing NL-201's effectiveness against various cancers.
- Net loss of $9.7 million in Q2 2020, a significant increase from prior year.
- Increased R&D expenses of $4.8 million in Q2 2020, up from $2.0 million in Q2 2019.
- NL-201 IND submission anticipated during fourth quarter of 2020
- Recent financing raises
$71.4M in net proceeds to enable broad NL-201 clinical plan and product pipeline development into 2023 - Company to host Conference Call Today, August 12, 2020 at 1:30 p.m. Pacific / 4:30 p.m. Eastern
SEATTLE, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced financial results for the second quarter ending June 30, 2020 and a midyear corporate update.
“All of the preclinical activities for NL-201 are substantially complete, and we are excited to be moving towards our first clinical trial in patients with advanced solid tumors,” said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. “To our knowledge, this will be the first fully de novo protein to enter clinical testing and has the potential to improve outcomes for patients with a wide variety of cancers. Additionally, our research group continues to advance future pipeline programs and to broaden the de novo protein design platform, some of which was highlighted during the recent AACR-II Conference.”
Recent Updates
NL-201 Development
In June, Neoleukin announced the presentation of preclinical data on its lead immunotherapy candidate NL-201, an IL-2 and IL-15 agonist, and applications of its de novo protein design platform at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.
Key findings include the ability of NL-201 to potently stimulate and expand key cancer-killing cells and induce robust and durable antitumor activity across many tumor types as well as encouraging immunogenicity data in non-human primates. New data highlights the ability of NL-201 to stimulate and expand CD8+ and NK cells at very low doses with minimal impact on immunosuppressive regulatory T cells. Additionally, low incidence of immunogenicity was observed following five weekly doses of NL-201 in non-human primates.
Neoleukin remains focused on its efforts to support an Investigational New Drug (IND) Application for its lead therapeutic, NL-201, anticipated during the fourth quarter of 2020, and is working with key vendors to finalize all activities and study reports. At this time, Neoleukin does not expect a delay due to COVID-19 but acknowledges the potential exists for this timing to be impacted.
Other Applications of De Novo Protein Design Presented at AACR Virtual Meeting
Research presented highlights a conditional activation approach – de novo split technology – demonstrating that de novo proteins can be divided into two inactive pieces that regain the ability to bind receptors when co-located in the tumor microenvironment. This split approach to conditional activation may increase the therapeutic index and offers the potential to create next-generation de novo therapeutics.
Additional research demonstrated that NL-201 and targeted variants may improve outcomes when combined with CAR-T cells in vivo in lymphoma and solid tumor models.
De Novo Protein Design for Coronavirus
In the past several months, Neoleukin scientists developed NL-CVX1, a fully de novo ACE2 decoy that binds to the SARS-CoV2 spike protein and neutralizes viral infection of mammalian cells in vitro. This protein is highly stable, was designed to be resilient to viral mutation, and has the potential for local administration to treat and/or prevent infection. The early results of this discovery research were recently posted on the public access website bioRxiv.org.
Board Appointment
In June, Neoleukin announced the appointment of Erin Lavelle to the Company’s Board of Directors. Ms. Lavelle has more than 20 years of strategic and operational leadership experience in the biopharmaceutical industry. Ms. Lavelle started her career in Merrill Lynch’s Investment Banking group, spent 15 years at Amgen, and most recently served as Chief Operating Officer for Alder Biopharmaceuticals, Inc.
Follow-On Offering
In July, Neoleukin closed a public offering of approximately 3.2 million shares of common stock and pre-funded warrants to purchase 1.7 million shares of common stock with an exercise price of
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled
Based upon our current operating plan, and following the completion of the July follow-on offering, Neoleukin believes that its cash-on-hand will be sufficient to fund operations into 2023.
R&D Expenses: Research and development expenses for the second quarter of 2020 increased to
G&A Expenses: General and administrative expenses for the second quarter of 2020 increased to
Net Loss: Net loss for the second quarter of 2020 was
Conference Call Information
Neoleukin will host a conference call today to provide a second quarter corporate update and review financials. Details are as follows:
Date: August 12, 2020
Time: 1:30 p.m. Pacific / 4:30 p.m. Eastern
Toll-free: (866) 357-7878
International: (315) 625-3088
Conference ID: 5862564
Webcast URL: http://investor.neoleukin.com/events
The archived audio webcast with slides will be available on the Investor Relations section of the Neoleukin website approximately two hours after the event and will be available for replay for at least 30 days after the event.
About Neoleukin Therapeutics, Inc.
Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. Neoleukin’s lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to improve tolerability and activity by eliminating the alpha receptor binding interface. For more information, please visit the Neoleukin website: www.neoleukin.com.
Safe Harbor / Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, planned development activities and timelines, use and adequacy of cash reserves and the potential benefits of the company’s product candidates and platform. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Examples of such forward-looking statements include but are not limited to statements regarding the therapeutic properties and potential of the company’s de novo protein design technology and statements regarding the impact of COVID-19 on the company’s ongoing and planned clinical trials. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the company’s cash forecasts, the company’s ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, the timing and results of preclinical and clinical trials, the timing of announcements and updates relating to the company’s clinical trials and related data market conditions and further impacts of COVID-19, that could cause actual results to differ materially from what Neoleukin expects. Further information on potential risk factors that could affect Neoleukin’s business and its financial results are detailed under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Neoleukin undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts:
Media
Julie Rathbun
206-769-9219
jrathbun@neoleukin.com
Investors
Solebury Trout
Brian Korb
646-378-2923
bkorb@troutgroup.com
NEOLEUKIN THERAPEUTICS INC.
Condensed consolidated balance sheet data
(Unaudited)
(In thousands of U.S. dollars)
| JUNE 30, 2020 | DECEMBER 31, 2019 | ||||
| Assets | |||||
| Cash and cash equivalents | $ | 129,596 | $ | 143,093 | |
| Other current assets | 1,401 | 503 | |||
| Other non-current assets | 14,327 | 3,427 | |||
| Total assets | $ | 145,324 | $ | 147,023 | |
| Liabilities | |||||
| Current liabilities | $ | 6,320 | $ | 4,743 | |
| Non-current liabilities | 10,305 | 593 | |||
| Total liabilities | 16,625 | 5,336 | |||
| Stockholders’ equity | 128,699 | 141,687 | |||
| Total liabilities and stockholders' equity | $ | 145,324 | $ | 147,023 | |
NEOLEUKIN THERAPEUTICS, INC.
Condensed consolidated statements of operations
(Unaudited)
(In thousands of U.S. dollars, except per share and share amounts)
| THREE MONTHS ENDED JUNE 30, | SIX MONTHS ENDED JUNE 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 4,843 | $ | (1,995 | ) | $ | 10,341 | $ | (1,891 | ) | |||||
| General and administrative | 4,926 | 2,423 | 8,499 | 4,978 | |||||||||||
| Total operating expenses | 9,769 | 428 | 18,840 | 3,087 | |||||||||||
| Other income, net | 23 | 427 | 452 | 878 | |||||||||||
| Net loss | $ | (9,746 | ) | $ | (1 | ) | $ | (18,388 | ) | $ | (2,209 | ) | |||
| Net loss per common stock – basic and diluted | $ | (0.20 | ) | $ | - | $ | (0.37 | ) | $ | (0.09 | ) | ||||
| Basic and diluted weighted average number of common stock outstanding | 49,392,533 | 23,537,368 | 49,280,492 | 23,537,368 | |||||||||||
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