Biotech Alert: Searches spiking for these stocks today

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

• XTL Biopharmaceuticals (XTLB), 14,267% surge in interest
• Hoth Therapeutics (HOTH), 4,717% surge in interest
• Crinetics Pharmaceuticals (CRNX), 803% surge in interest
• Cerus Corp (CERS), 653% surge in interest
• Brainstorm Cell (BCLI), 552% surge in interest
• BioNTech (BNTX), 299% surge in interest
• Atossa Genetics (ATOS), 290% surge in interest
• Atreca (BCEL), 246% surge in interest
• Chimerix (CMRX), 222% surge in interest
• Seelos Therapeutics (SEEL), 207% surge in interest

Pipeline and key clinical candidates for these companies:

XTL is an IP portfolio company that has intellectual property surrounding hCDR1 for the treatment of Lupus disease and Sjögren’s Syndrom and has decided to explore collaboration with a strategic partner in order to execute the clinical trials. In parallel, the company is actively looking to expand and identify additional IP based assets.

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 stated.

Crinetics Pharmaceuticals is focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Paltusotine, an investigational, oral somatostatin receptor type 2 agonist, is in Phase 3 clinical development for acromegaly and Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics has demonstrated pharmacologic proof-of-concept in Phase 1 clinical studies for CRN04777, an investigational, oral somatostatin receptor type 5 agonist in development for congenital hyperinsulinism, and for CRN04894, an investigational, oral ACTH antagonist in development for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH.

Cerus Corporation is dedicated to “safeguarding the world’s blood supply and aims to become the preeminent global blood products company,” it has said. The company develops and supplies technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and “remains the only pathogen reduction system with both CE Mark and FDA approval for these two blood components,” Cerus states. Also in the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

BioNTech is “pioneering novel therapies for cancer and other serious diseases.” BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab (GMAB), Sanofi (SNY), Genentech, a member of the Roche Group (RHHBY), Regeneron (REGN), Genevant, Fosun Pharma, and Pfizer (PFE).

Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

Atreca is a biopharmaceutical company developing novel antibody-based therapeutics generated by its differentiated discovery platform, with a focus on antibody-drug conjugates. Atreca’s platform “allows access to an unexplored landscape in oncology through the identification of unique antibody-target pairs generated by the human immune system during an active immune response against tumors,” the company states. These antibodies provide the basis for “a pipeline of first-in-class oncology programs,” led by APN-497444, an ADC targeting a novel tumor glycan, in addition to MAM01/ATRC-501, a clinical candidate licensed to the Bill & Melinda Gates Medical Research Institute for the prevention of malaria, the company says.

Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma.

Seelos Therapeutics is focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system, or CNS, disorders and other rare diseases. The company’s portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior in Major Depressive Disorder, amyotrophic lateral sclerosis, or ALS, and spinocerebellar ataxia, or SCA, as well as early-stage programs in Huntington’s disease, Alzheimer’s disease, and Parkinson’s disease.

Recent news on these stocks:

March 21

Atossa Therapeutics announced on Tuesday that the pre-menopausal, Estrogen Receptor positive, or ER+ / Human Epidermal Growth Factor Receptor 2 negative, breast cancer patient who received neoadjuvant and adjuvant-endoxifen therapy under an FDA-approved “expanded access” program has completed five years of treatment. As of the date of this press release, the patient remains cancer-free and has reported no significant safety or tolerability issues over the course of her treatment. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. In late 2018, a 51-year-old premenopausal woman was diagnosed with a moderately differentiated invasive ductal breast carcinoma with the most frequently reported subtype: ER+, PR+, and HER2-. The initial diagnostic biopsy demonstrated that 90% of the tumor cells were ER+ and 20% expressed Ki-67, a tumor proliferation antigen. Pharmacogenomics analysis showed a CYP2D6 genotype of CYP2D6*4/*4, a nonfunctioning variant, suggesting tamoxifen would be a poor treatment option. Other than breast cancer, the patient had no comorbidities and took no medications. Her family history was strong for osteoporosis, a contraindication for aromatase inhibitor treatment. Neoadjuvant treatment is given in the window of time between the diagnosis and the primary treatment, which in the case of locally advanced breast cancer is surgery. The intent of neoadjuvant therapy is to slow the growth of the cancer or even shrink the cancer prior to surgery. The goal of this treatment is to help increase the effectiveness of surgery, and it has also been shown to reduce the likelihood that the cancer returns. The FDA authorized a single-patient study under its Expanded Access or compassionate use program for this woman to receive 4 mg/day oral (Z)-endoxifen for 20 days before surgery. Following surgery, her physician recommended adjuvant therapy but, like many women, she was not a candidate for tamoxifen due to her low liver enzyme activity. She also did not want to take drugs to suppress her ovarian function and go into early menopause, which meant aromatase inhibitors were not an option. Given the strong and rapid response to (Z)-endoxifen, it was recommended that she continue taking (Z)-endoxifen. This led to an additional compassionate use authorization by the FDA to allow this patient to continue taking 4 mg/day (Z)-endoxifen in the adjuvant setting. She has now completed five years of daily (Z)-endoxifen. As of the date of this press release, she has not had a recurrence of breast cancer or a new cancer in the contralateral breast, as assessed by clinical examination and mammography. Additionally, the treatment has been well tolerated, and there were no vasomotor symptoms commonly associated with tamoxifen. Under the FDA Expanded Access IND program, the use of Atossa’s proprietary (Z)-endoxifen is restricted to this patient only.

March 20

XTL Biopharmaceuticals announced that it has entered into a binding term sheet with The Social Proxy, a web data company. Pursuant to the term sheet, the company will acquire all of the issued and outstanding share capital of Social Proxy on a fully diluted basis in exchange for the issuance by the company to the shareholders of the Social Proxy, by way of a private placement, such number of ADS’s of the company, representing immediately after such issuance, 44.6% of the issued and outstanding share capital of the company and the payment of $430,000 to the shareholders of the Social Proxy. The proposed transaction is part of the company’s strategy to expand its assets portfolio with high potential assets. In order to support the company’s financial needs and in order to complete the transaction, the company has secured a commitment of an investment at an amount of $1.5M through a private placement to be consummated upon the closing of the transaction.

BioNTech reported Q4 EPS EUR 1.90 vs. EUR 9.26 last year, and reported Q4 revenue EUR 1.48B vs. EUR 4.28B last year. “2023 was another year of good performance for BioNTech. We have maintained our leading position in the COVID-19 vaccine market which lays the foundation for establishing a sustainable respiratory vaccines business. In oncology, we have strengthened our core competencies by entering into several partnerships and have made numerous clinical advances. Today, our oncology pipeline encompasses multiple candidates in mid- and late-stage clinical development, including investigational ADCs, mRNA vaccines and innovative immunotherapies,” said Prof. Ugur Sahin, M.D., CEO. “Our goal is to achieve product approvals in ten oncological indications by 2030 and with this improve the treatment options for patients around the globe.” BioNTech said it sees FY24 revenue EUR 2.5B-EUR 3.1B.

March 19

Hoth Therapeutics unveiled “positive” pre-clinical research involving HT-ALZ, an Alzheimer’s disease therapeutic. HT-ALZ combats neuroinflammation and cognitive deficits associated with Alzheimer’s Disease. By antagonizing the NK1 receptor, HT-ALZ reduces soluble Abeta levels in the brain’s interstitial fluid and diminishes anxiety-like behavior and enhances cognitive function in preclinical models. The research presents evidence of HT-ALZ’s capacity to improve memory tasks related to the hippocampus and sensorimotor gating. While the effects on plaque deposition and Abeta levels were inconclusive, the treatment’s cognitive benefits suggest that HT-ALZ’s mode of action may involve a reduction in brain inflammation, thereby improving cognitive outcomes for Alzheimer’s patients. Hoth Therapeutics remains committed to further research and development of HT-ALZ, including analyses of its effects on microglial activation and brain inflammation.

Cerus announced topline results for ReCePI, a Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells transfused to complex cardiac surgery patients. The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury, or AKI, following transfusion of study RBCs. AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery. In transfused subjects, by modified intent to treat the incidence of AKI was 29.3% for INTERCEPT RBC recipients compared to 28% for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14%. The safety endpoint of the proportion of patients with any related treatment-emergent adverse events, or TEAEs, within 28 days of last transfusion was not significantly different for INTERCEPT RBCs compared to conventional RBCs. There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs. The trial’s independent Data Safety and Monitoring Board, or DSMB, evaluated these patients and was supportive of continued transfusion, having found no adverse health effects from trial transfusions. This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs. Cerus plans to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular premarket approval, or PMA, submission. Cerus anticipates initiating a modular PMA application to the FDA in the second half of 2025, with the final PMA module submission planned for the second half of 2026, upon the anticipated completion of the RedeS clinical trial. Data from preclinical studies, manufacturing information, previously reported Phase 1 and Phase 2 clinical trials in the U.S., and the successfully completed Phase 3 clinical trials in the EU will be included in the modular PMA submission. Cerus expects the data from the ReCePI clinical trial to be presented at upcoming medical conferences as well as to be submitted for peer reviewed publication.

Crinetics Pharmaceuticals announced positive topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of oral, once-daily investigational paltusotine for the treatment of acromegaly, a serious rare disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. PATHFNDR-2 was a 24-week treatment period followed by an optional open-label extension study evaluating paltusotine in 111 participants with acromegaly who were not pharmacologically treated. The study met statistical significance on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 level less than or equal to 1.0 times the upper limit of normal vs. those taking placebo. All secondary endpoints also met statistical significance. In PATHFNDR-2, paltusotine was generally well-tolerated and no serious adverse events were reported in participants treated with paltusotine. The PATHFNDR Program consists of two Phase 3 double-blind, placebo-controlled studies. Crinetics believes these studies could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from standard of care.

Seelos Therapeutics provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. The company plans to request a meeting with the FDA to discuss potential next steps for the programThe study was designed to evaluate SLS-005, a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy, in decreasing the slope of the ALS Functional Rating Scale and separation from placebo in Function and Mortality in an all-comers population of Persons with ALS. While the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set, by showing a 13% improvement in Function and Mortality with an 88% success probability, vs. the pre-specified 98%, it showed a potential signal of efficacy in a pre-specified subgroup. In the pre-specified subgroup of PALS treated with SLS-005, without Relyvrio, the top-line data favored SLS-005 versus placebo in efficacy measures in the Efficacy Relyvrio Free data set, including: a 22% improvement in slope of change in ALSFRS-R assessment adjusted for mortality, with an 89% success probability, at 24 weeks the rate of decline in ALSFRS-R slope also favored the SLS-005 treatment group versus placebo over 6 months; a 25% slowing of Slow Vital Capacity decline versus placebo at 24 weeks. Seelos plans to run additional analyses, including biomarkers of neurodegeneration, neurofilament light chain, exploratory efficacy results, subgroups and post-hoc analyses. SLS-005 was generally well-tolerated and comparable to placebo in safety. There was an imbalance of deaths/death equivalents observed in the study, with more events seen in the SLS-005 group compared to placebo, all were considered unrelated to the study drug.

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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 20-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.