These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Kalvista Pharmaceuticals (KALV), 3,111% surge in interest
- PolarityTE (PTE), 1,863% surge in interest
- Kala Pharmaceuticals (KALA), 700% surge in interest
- Tracon Pharmaceuticals (TCON), 525% surge in interest
- Innate Pharma (IPHA), 379% surge in interest
Pipeline and key clinical candidates for these companies:
KalVista Pharmaceuticals is focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a portfolio of small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema, or HAE, and diabetic macular edema, or DME. KalVista is developing sebetralstat as an oral on-demand therapy for HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program "represents a new generation of therapies that may further improve treatment for people living with HAE," the company says. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.
PolarityTE is developing regenerative tissue products. PolarityTE’s first regenerative tissue product is SkinTE. PolarityTE has an open investigational new drug application for SkinTE with the FDA and is now pursuing the first of two pivotal studies on SkinTE needed to support a biologics license application, or BLA. SkinTE is available for investigational use only.
Kala is dedicated to the research, development and commercialization of therapies for rare diseases of the eye. Kala’s lead product candidate, KPI-012, is in clinical development for the treatment of persistent corneal epithelial defect, or PCED, a rare disease of impaired corneal healing, which has received orphan drug designation from the FDA. Kala is also targeting the potential development of KPI-012 for the treatment of Partial Limbal Stem Cell Deficiency and ocular manifestations of moderate-to-severe Sjögren’s and plans to initiate preclinical studies to evaluate the utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease.
Tracon is advancing a pipeline of novel targeted cancer therapeutics and seeks to partner with other life science companies. The company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. Tracon has said it believes it "can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent."
Innate Pharma is focused on a pipeline of antibodies that it says includes "several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need." Innate calls itself "a pioneer in the understanding of Natural Killer cell biology" that "has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering."
Recent news on these stocks:
December 27
KalVista Pharmaceuticals announced that it has entered into a subscription agreement with institutional investors to sell, in a registered direct offering, an aggregate of 9.484M shares of common stock at a price of $6.00 per share and 182K prefunded warrants at a price of $5.99 for total gross proceeds of approximately $58M, before deducting estimated offering expenses. The offering is expected to close on December 28, subject to the satisfaction of customary closing conditions. The company intends to use the proceeds of this $58M offering to fund clinical trials, commercial sales development, research, working capital, capital expenditures and other general corporate purposes. With the financing, combined with the company’s existing cash balance and anticipated receipts as of October 31, KalVista now expects to be able to fund operations into 2025.
PolarityTE announced that it signed a non-binding letter of intent, LOI, with Michael Brauser for him to make an offer to acquire 100% of the outstanding equity interests of the company at a proposed offering price of $1.03 per common share, which would be paid entirely in cash.
Kala Pharmaceuticals announced that the FDA has accepted an investigational new drug application for the company’s lead product candidate, KPI-012, a human mesenchymal stem cell secretome, initially in development for the treatment of persistent corneal epithelial defect, or PCED. The Phase 2b clinical trial will be a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution compared to vehicle when dosed topically four times per day (QID) for 56 days. The trial is expected to enroll approximately 90 adult patients with PCED, and the primary endpoint of the trial will be complete healing of the PCED as measured by corneal fluorescein staining. Kala expects to initiate enrollment in the trial in the first quarter of 2023 and expects to report topline data in the first quarter of 2024. If the results are positive, Kala believes this trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application (BLA) to the FDA.
Tracon Pharmaceuticals announced entry into an up to $30M non-recourse financing agreement. $3.5M will be funded before December 31, 2022. The additional $26.5M, or a lesser amount based on the amount awarded, will be available subject to the award exceeding a threshold and satisfaction of other conditions set forth in the agreement, with 25% of the total being available to be funded after award announcement and the remainder available over a multi-year period. "This non-dilutive funding provides for upfront capital along with potential post-award financing, so we may realize the value of a potential arbitration award once issued. We look forward to the announcement of the arbitration award that is expected in the first quarter of 2023," said Charles Theuer, Tracon’s CEO.
About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 15-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.
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