Biotech Alert: Searches spiking for these stocks today

Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:

• Kala Pharmaceuticals (KALA), 4,653% surge in interest
• Rubius Therapeutics (RUBY), 1,229% surge in interest
• Minerva Neuroscience (NERV), 1,081% surge in interest
• Jounce Therapeutics (JNCE), 947% surge in interest
• Hoth Therapeutics (HOTH), 739% surge in interest

Pipeline and key clinical candidates for these companies:

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.

Rubius Therapeutics is a biopharmaceutical company developing "an entirely new class of cellular medicines" called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases.

Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system, or CNS, diseases. Minerva’s portfolio of compounds includes roluperidone, or MIN-101, in clinical development for negative symptoms of schizophrenia, and MIN-301 for Parkinson’s disease.

Jounce Therapeutics is a clinical-stage immunotherapy company that currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its discovery engine based on its Translational Science Platform. Jounce’s highest priority program, JTX-8064, is a LILRB2 receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. JTX-8064 is currently being investigated alone and in combination with pimivalimab, Jounce’s internal PD-1 inhibitor, in one monotherapy and eight indication-specific combination therapy cohorts in the Phase 1/2 INNATE trial and is currently enrolling patients with advanced solid tumors in the Phase 2 portion of the study. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce’s broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to GS-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences (GILD).

Hoth Therapeutics refers to itself as "a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing." Hoth "collaborates and partners with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options," the company states.

Recent news on these stocks:

December 29

Hoth Therapeutics announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 2M shares of its common stock and warrants to purchase up to an aggregate of 2.5M shares of common stock, at a purchase price of $5.00 per share and accompanying warrant in a private placement priced at-the-market under Nasdaq rules. The gross proceeds to the company from the private placement are expected to be $10M, before deducting the placement agent’s fees and other offering expenses payable by the company. The private placement is expected to close on or about January 3, 2023, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement.

December 28

Minerva Neurosciences announced that, following the Type A meeting held on November 30, the FDA has confirmed that the refuse to file letter dated October 14 remains in effect in respect of the company’s New Drug Application, or NDA, for roluperidone for the treatment of negative symptoms in patients with schizophrenia.

December 27

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.

Gilead Sciences (GILD) and Jounce Therapeutics "amended their existing license agreement for GS-1811, enabling Gilead to buy out remaining contingent payments potentially due under the license agreement executed in August 2020. As part of the transaction, certain operational obligations of the parties related to GS-1811, an anti-CCR8 antibody, set forth in the license agreement have also been terminated. Gilead will acquire certain related intellectual property, including all outstanding rights of Jounce to GS-1811, pursuant to the transaction agreement. GS-1811, a potentially first-in-class immunotherapy, is designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells in the tumor microenvironment and is currently in Phase 1 clinical development as a possible treatment for patients with solid tumors. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission, Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with Jounce to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.04. Jounce will no longer be entitled to receive the remaining contingent payments of up to $645M in milestones and high single-digit to mid-teens royalties based upon worldwide sales under the original license agreement."

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.

Keywords: biotech, biotech sector, biotech alert, investingchannel, XBI, SPDR S&P Biotech ETF