InSitu Biologics Raises $2 Million to Advance Non-Opioid Pain Therapy AnestaGel into Clinical Trials
VCBeat (WeChat Official Account: vcbeat) has learned that InSitu Biologics, an emerging biotechnology company headquartered in Minnesota, USA, has raised over $2 million from the public through a Regulation A+ offering. The company is projected to raise $10 million by 2019.
In the fourth quarter of 2017, InSitu Biologics raised over $400,000 in funding. In the second quarter of 2018, InSitu Biologics announced the launch of a Reg A+ fundraising campaign.
On July 17, 2018, InSitu Biologics received approval from the U.S. Securities and Exchange Commission (SEC) for a financing qualification allowing it to raise up to $10 million. Reportedly, InSitu Biologics will use these funds to further advance its non-opioid drug candidates into clinical trials.
Since the announcement of this fundraising round, InSitu Biologics has sold out three classes of SEC-compliant shares. Currently, InSitu Biologics has suspended its listing. To better reflect the company’s significant achievements and business development, InSitu Biologics is poised to submit a new valuation and pricing assessment report to the SEC.
InSitu Biologics is an emerging biotechnology company. Under the leadership of President and CEO James Segermark, InSitu Biologics has launched a novel non-opioid analgesic named AnestaGel. Preclinical studies have demonstrated that AnestaGel provides sustained, long-lasting pain relief and has been shown to be effective for postoperative regional pain management following surgical procedures such as fracture repair, cosmetic surgery, hip/knee arthroplasty, and hernia repair.
Currently, pain management remains a critical need in intraoperative and postoperative patient care. Generally, local anesthetics are commonly used to alleviate pain, but their duration of action is limited. Furthermore, while opioids are effective for pain treatment, they carry risks such as high potential for addiction. In the United States, an average of 115 people die from opioid overdoses each day.
AnestaGel, a preclinical-stage analgesic developed by InSitu Biologics, is composed of bupivacaine and delivers a biocompatible gel over 72–96 hours to anesthetize patient tissues and nerves, thereby providing pain relief for three days or longer.
Unlike other analgesics, AnestaGel acts specifically on targeted areas within the patient’s body without distributing to other regions, and is readily metabolized (based on preclinical trial results), making it an effective non-opioid alternative for managing surgical pain.
Prior to this funding round, InSitu Biologics published peer-reviewed preclinical research in the Journal of Pain Research, which found that AnestaGel possesses the following characteristics:
Compared with industry-leading liposomal sustained-release drugs, the duration of action can be extended by 300%;
Nerve block lasting more than 72 hours (24–48 hours for lipid-based formulations);
Carries eight times more analgesic than liposome-based drugs while remaining non-toxic.
“The development of non-addictive, non-opioid analgesics lags far behind research in other disease areas,” said James Segermark, President and CEO of InSitu Biologics. “Addiction often begins with postoperative pain management, and there are currently few non-opioid options to address this issue. Therefore, our investors clearly understand that we need to drive change.”
Reg A+ is an alternative to traditional initial public offerings (IPOs), making it easier for small startups in the United States or Canada to raise capital.
To encourage the development of small businesses, the U.S. Congress passed the Jumpstart Our Business Startups (JOBS) Act in 2012, aiming to support the growth and employment of small enterprises by lowering regulatory barriers for companies seeking to go public and allowing them to have more private shareholders.
In 2015, Title IV of the JOBS Act went into effect, allowing small startups to raise capital from the public and offer equity in addition to accredited investors.
Prior to conducting a small-scale IPO, the issuing company must submit an offering memorandum to the U.S. Securities and Exchange Commission (SEC) and obtain qualification certification. Thereafter, it may raise capital from the public by issuing company stock, with a maximum fundraising cap of $50 million within a 12-month period.
Furthermore, issuing companies can also combine public funds with private capital from venture investors through Reg A+ to create larger-scale fundraising campaigns.