The Nasdaq has been a hopping place this year, with new biotechs adding their symbol to the ticker every week and others flooding the market with more stock. Every time positive trial data is reported or a nod from the FDA comes through, stock prices soar.
TG Therapeutics is a great example of one company who’s gone from zero to hero on the exchange this year, and is still undervalued according to some experts. TGTX shares exploded in 2020, starting the year at less than $11 and coming in today at $51.55, a 371% increase.
Cashing in on their pipeline’s anticipated success, the New York-based biopharma is in the midst of a public offering of 6.32M shares of common stock at $43.50 a piece. Gross proceeds are expected to be around $275M before expenses.
TG recently announced positive topline results from two of their global Phase III clinical trials for relapsing forms of MS. In the two trials, patients receiving TG’s ublituximab had a reduced annualized relapse rate (ARR) of 60% and 50% less than the patients treated with Sanofi’s current approved treatment aubagio.
Both trials were conducted under an SPA, Special Protocol Assessment agreement with the FDA to ensure the trial design would fit the bill when presented to regulators for approval. With that in mind, experts anticipate a high probability of FDA approval for ublituximab in the coming year.
Another TG lead candidate umbralisib is already under review by the FDA for accelerated approval for patients with marginal zone lymphoma in patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies.
At the ASH annual meeting, TG CEO Michael Weiss stated, “Data presented today supported our current NDA for umbralisib monotherapy, and we continue to work towards our PDUFA goal date of February 15, 2021 for MZL and June 15, 2021 for FL. Additionally, we plan to complete our BLA/NDA submission for the U2 combination in CLL in the first half of 2021.”
Seeing the success other life science companies are finding on the Nasdaq has newcomer BioAtla gearing up for their IPO. Trading today, the biopharma company is offering 10.5M shares at $18 apiece with a goal of $189M in proceeds. This is a 38% increase in funding over their initial proposal of 9.4M shares ranging $15-17.
Based in San Diego, BioAtla is developing a novel class of specific and selective antibody-based therapeutics. The company’s “conditionally active biologics” only activate when they detect proximity to a tumor, thereby reducing systemic toxicity.
Funds from this raise will be used to propel lead program BA3011 through two Phase II studies – one for the treatment of soft tissue and bone sarcoma and the other for NSCLC patients. Another chunk of change will go towards BA3021 to propel it through Phase II trials for NSCLC and melanoma.
BioAtla has partnered with a couple big names, most notably global player BeiGene, a Chinese biotech focused on molecularly-targeted and immuno-oncology cancer therapeutics since 2019. The partnership’s candidate, BA3074 is gearing up for a Phase I dose escalation trial to be initiated in 2021.