On Target Laboratories Secures $30 Million for Commercialization of CYTALUX® (pafolacianine) injection

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Nov 16, 2023, 08:00 ET

Funding will allow the company to bring novel technology that illuminates lung and ovarian cancer during surgery to more patients

WEST LAFAYETTE, Ind., Nov. 16, 2023 /PRNewswire/ -- On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, today announced the completion of a $30 million Series C financing. This significant investment will play a pivotal role in accelerating the commercialization of the company's novel compound, CYTALUX, the only FDA approved molecular imaging agent that illuminates lung and ovarian cancer as an adjunct during surgery, enabling surgeons to detect more cancer for resection.

"This investment empowers us to accelerate the commercialization of our novel technology, further solidifying our position at the forefront of intraoperative molecular imaging," said Ben Lundgren, President and CEO of On Target Laboratories. "This financing is another vote of confidence in our mission to illuminate cancer intraoperatively so it can be removed completely."

The funding was backed by new and existing investors H.I.G. Capital, The Hurvis Group, Johnson & Johnson Innovation – JJDC, Inc., Pension Fund of the Christian Church, 3B Future Health Fund, Elevate Ventures, and Olympus Innovation Ventures.

"On Target Laboratories is at the forefront of a new wave of fluorescent agents that are game changers for surgical imaging," said Nacho Abia, Chief Strategy Officer at Olympus. "The ability of CYTALUX to illuminate lung and ovarian cancer during surgery is a stellar example of what we describe at Olympus as 'making the invisible visible'."

This infusion of capital will enable On Target Laboratories to expedite the commercial launch of CYTALUX and amplify its market presence, ultimately benefiting patients and healthcare providers across the United States.

"This financing serves as a testament to the strength of On Target Laboratories' technology, especially in light of the complexities posed by the current financial landscape," said Gwen Watanabe, Managing Director of H.I.G. BioHealth Partners and On Target Laboratories Board Member. "We are delighted to see the support from both private equity and strategic investors as we introduce CYTALUX to the cancer community."

In August, On Target Laboratories announced that the Centers for Medicare & Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for CYTALUX use in ovarian and lung cancer surgery. Under NTAP, CMS will provide hospitals with additional payment of up to 65 percent of the average cost of CYTALUX, which is expected to expand access of the technology to more patients.

The closing of this funding round closely coincides with Stryker's recent introduction of the 1788 Platform, the only minimally invasive surgical camera currently cleared for use with CYTALUX. The convergence of Series C financing, NTAP reimbursement, and the nationwide rollout of this visualization solution creates a unique opportunity for On Target to expedite the expansion of CYTALUX.

About On Target Laboratories, Inc.

On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX, the company's first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information visit www.ontargetlabs.com and www.cytalux.com.

What is CYTALUX?
CYTALUX is an FDA approved prescription medication that is given prior to surgery to adult patients who have ovarian cancer or known or suspected cancer in the lung. It helps surgeons visualize ovarian and lung cancer lesions during surgery.

Important Safety Information
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, allergic reaction, elevation in blood pressure, indigestion, and chest discomfort were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.

Risk of Misinterpretation
Errors may occur with the use of CYTALUX. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Pregnancy
CYTALUX may cause fetal harm when administered to a pregnant woman. There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Contact your healthcare provider with a known or suspected pregnancy.

Folate Supplementation Usage
Folic acid may reduce the detection of cancerous tissue with CYTALUX. Patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX.

Adverse Reactions
The most common side effects of CYTALUX reported in clinical trials were nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), allergic reaction (2%), elevation in blood pressure (1%), indigestion (1%), and chest discomfort (1%) during administration.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CYTALUX. For more information, ask your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See full Prescribing Information for more details.

SOURCE On Target Laboratories, Inc.