Wall Street’s enthusiasm ran high for Cambridge, Mass.-based Black Diamond Therapeutics Inc. (BDT), shares of which (NASDAQ:BDTX) closed 108% higher at $39.48, after the company priced its upsized IPO of about 10.5 million shares at $19 each, for gross proceeds of about $201 million.
As recently as December, the company pulled down $85 million in a series C financing. BDT’s lead product candidates target oncogenic driver mutations of the ErbB kinases in EGFR and HER2. At the time, the firm noted that it had raised $194 million thus far. With the IPO, which first set sights on 8.9 million shares in the range of $16 to $18 each, the picture grows even brighter.
BDT plans to start a combined phase I/II trial of its most advanced candidate, BDTX-189, in the first half of 2020. Continuing to expand are earlier-stage research programs and the Mutation-Allostery-Pharmacology (MAP) platform, which the company deploys to identify oncogenic mutations. BDT initially operated in stealth mode from New York and from Versant Venture’s Basel, Switzerland-based Ridgeline Discovery Engine.
BDTX-189 was designed to inhibit a family of oncogenic proteins defined by mutations which occur outside the adenosine triphosphate site, i.e., noncanonical mutations. They occur across a range of tumor types that affect EGFR and HER2. The drug spares normal wild-type EGFR, which should improve toxicity over other ErbB kinase inhibitors. The IND for BDTX-189 was submitted in November, and the FDA gave its blessing the following month.
For the years ended Dec. 31, 2017, and 2018, BDT reported net losses of $4.6 million and $8.9 million, respectively. For the nine months ended Sept. 30, 2019, the firm chalked a net loss of $25.4 million, and as of the same date, BDT’s accumulated deficit totaled $41.1 million. The company had cash and cash equivalents of $78.7 million.
Ahead for BDT lie the identification of a lead product candidate and IND-enabling studies in the company’s glioblastoma program, according to SEC paperwork. “We have no experience as a company in conducting clinical trials,” the IPO filing notes in its section on risks. “In part because of this lack of experience, we cannot be certain that our ongoing preclinical studies will be completed on time or if the planned preclinical studies and clinical trials will begin or be completed on time, if at all.”
In the planned open-label experiment with BDTX-189, the company will examine the safety profile and establish the recommended phase II dose in patients with bladder cancer, endometrial cancer, breast cancer, gastric cancer, colon cancer and non-small-cell lung cancer, as well as other solid tumors. The phase I portion is expected to enroll up to 84 patients with solid tumors that have alterations likely to be associated with antitumor activity based on preclinical studies, as well as some patients with the targeted genetic mutations. “The phase I portion may have to evaluate different dosing schedules if the pharmacokinetic or safety data suggest once-daily dosing is suboptimal,” BDT said, which could delay the start of the phase II portion, expected to enroll up to 100 patients with the targeted mutations to evaluate efficacy as determined by objective response rate.
The IPO includes a 30-day option for underwriters to buy up to about 1.5 million more shares. J.P. Morgan Securities LLC, Jefferies LLC, and Cowen and Co. LLC, are acting as joint book-running managers, with Canaccord Genuity LLC serving as lead manager.
Annovis still trading above pricing
Still holding its own after pricing its IPO on Jan. 28 is Berwyn, Pa.-based Annovis Bio Inc., which set its offering of 2 million shares at $6 each, for gross proceeds of $12 million. Annovis granted the underwriters a 45-day option to purchase up to an additional 300,000 shares. Shares (NYSE:ANVS), which jumped to $9.59 on its first day of trading, dropped to $7.01, down $2.58, or 27% on Jan. 30. Thinkequity, a division of Fordham Financial Management Inc., acted as sole book-running manager.
Previously known as QR Pharma Inc., Annovis changed its name in June 2019. The company is developing therapies for the treatment of Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative conditions. ANVS-401 is the company’s lead compound, in the works for AD, its orphan indication AD and dementia in Down syndrome (AD-DS), and PD. It’s being pursued in those areas because in preclinical studies the candidate normalized axonal transport by inhibiting the neurotoxic proteins that kill nerve cells. The drug has been shown in human and animal studies to lower APP/Aβ, tau/phospho-tau and α-synuclein, the neurotoxic proteins that impair axonal transport and lead to inflammation and cell death, Annovis said. The compound was tested in three phase I trials that showed it to be well-tolerated. A phase IIa proof-of-concept study is ongoing in AD patients and the company plans to commence a second phase IIa study in PD patients.
“The industry has encountered challenges in targeting specifically one or the other neurotoxic protein, be it APP, tau or aSYN, indicating that targeting one neurotoxic protein alone does not change the course of neurodegeneration,” Annovis acknowledged in an SEC filing. “Our goal is to develop a disease-modifying drug for patients with neurodegeneration by leveraging our clinical and animal evidence in inhibiting at least the three most relevant neurotoxic proteins. We believe that we are the only company developing a clinical-stage proof-of-concept drug for AD-DS, AD and PD that inhibits more than one neurotoxic protein, and has a mechanism of action designed to restore nerve cell axonal and synaptic activity.”