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: 

• HCW Biologics (HCWB), 9,600% surge in interest
• GH Research (GHRS), 4,613% surge in interest
• Invivyd (IVVD), 2,621% surge in interest
• Kairos Pharma (KAPA), 720% surge in interest
• BriaCell Therapeutics (BCTX), 640% surge in interest
• Annovis Bio (ANVS), 394% surge in interest
• Calidi Biotherapeutics (CLDI), 182% surge in interest
• atai Life Sciences (ATAI), 166% surge in interest
• SeaStar Medical (ICU), 106% surge in interest

Pipeline and key clinical candidates for these companies:

HCW Biologics is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. 

GH Research is a clinical-stage biopharmaceutical company that says it is “dedicated to transforming the lives of patients by developing a practice-changing treatment in depression.” GH Research’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression.

Invivyd is a biopharmaceutical company that says it is “devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2.” In March 2024, Invivyd received emergency use authorization from the FDA for a monoclonal antibody in its pipeline of innovative antibody candidates.

Kairos Pharma says it is “at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer.” lead candidate ENV105 is an antibody that targets CD105-a protein identified as a key driver of resistance to various cancer treatments. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to “transform cancer care,” the company states.

Annovis is a late-stage clinical drug platform company “pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease,” the company states.

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are “designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety,” the company states.

atai is a clinical-stage biopharmaceutical company that says it is “aiming to transform the treatment of mental health disorders.”

SeaStar Medical is a commercial-stage therapeutic medical technology company that says it is “redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs.” The company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.

Recent news on these stocks:

February 5

Invivyd announced a strategic partnership with professional football coach Jim Harbaugh to raise awareness about the ongoing short and potential long-term risks of COVID-19 to the broad population and especially people who are immunocompromised, and encourage people to learn more about their potential options. This collaboration will highlight Coach Harbaugh in live and social media initiatives. “As a long-time coach, I want players on the field, fans in the stands, and friends and family gathering to enjoy the game. But, COVID-19 has and continues to sideline many people,” said Harbaugh. “While COVID-19 may seem like old news to some, many Americans continue to get sick, are hospitalized, and are dying from COVID-19, despite many of us having been vaccinated. The extent of damage to our bodies in the long-term is still unknown. The good news is for many there are options other than vaccines and people are encouraged to visit www.expandtheiroptions.com to learn more.”

Annovis Bio announced that the first two patients have been entered into the Phase 3 study evaluating buntanetap in early AD. “The launch of our highly anticipated AD study is a significant milestone in advancing buntanetap toward market approval and addressing the unmet medical need of millions of patients. Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis.

February 3

HCW Biologics announced that it has received clearance of its Investigational New Drug Application, IND, from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. HCW9302 is an injectable, first-in-kind interleukin 2 fusion protein complex constructed using the Company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL-2alphabetagamma receptors predominantly expressed on regulatory T cells, thereby activating and expanding Treg cells that can suppress unwanted immune and inflammatory responses.

GH Research reported the primary endpoint was met in a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001, an inhalable mebufotenin product candidate, in patients with treatment-resistant depression. GH001 led to a significant reduction from baseline of -15.2 points in Montgomery-Asberg Depression Rating Scale total score on Day 8, compared with +0.3 points in the placebo group. All secondary endpoints in the trial were met, with results consistent with the primary endpoint. Treatment with GH001 led to clinically and statistically significant improvements on the CGI-S and HAM-A scales and the Q-LES-Q-SF Questionnaire on Day 8, compared with placebo.

BriaCell Therapeutics announces an unprecedented clinical response including resolution of a lung metastasis with stable disease elsewhere. This patient is the first metastatic breast cancer patient treated with Bria-OTS. Bria-OTS is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study in metastatic recurrent breast cancer. Bria-OTS represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT which is currently in a pivotal Phase 3 study for metastatic breast cancer. A 78-year-old woman with metastatic breast cancer had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere.

January 31

SeaStar Medical Holding has entered into a securities purchase agreement with a single institutional investor for the issuance and sale of an aggregate of 3.53M shares of its common stock in a registered direct offering. In a concurrent private placement, the company also agreed to issue and sell to the investor warrants to purchase up to an aggregate of 3.53M shares common stock. The combined offering price for each share of common stock and accompanying warrants is $1.70. The closing of the offering is expected to occur on or about February 3, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $6M. SeaStar Medical intends to use the net proceeds of this offering for general corporate purposes, which may include additions to working capital and capital expenditures. H.C. Wainwright & Co. is acting as the exclusive financial advisor to SeaStar Medical in connection with the offering.

January 28

Calidi Biotherapeutics announced that its ending cash balance at December 31, 2024 was approximately $9.6M. Due to Calidi’s bolstered cash balance and success in recent fundraising, including proceeds resulting from its At-The-Market Offering Agreement, Calidi terminated its Standby Equity Purchase Agreement with YA II PN, an affiliate of Yorkville Advisors, effective January 23, 2025. In the fourth quarter of 2024, Calidi secured $9.5M in gross proceeds, before deducting expenses, through two public offerings, supplemented by $2M from warrant exercises and $3.1M from its ATM facility. In January 2025, Calidi announced another public offering that raised an additional $4.25M in gross proceeds, before deducting expenses. These public offerings have bolstered Calidi’s cash position, and together with the availability of the ATM facility, positioned it to meet its capital needs without relying on the SEPA framework.

atai Life Sciences announced topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe alcohol use disorder. BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time. The results showed that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, induced meaningful and sustained reduction in alcohol use and heavy drinking days in patients with moderate to severe AUD out to 12 weeks. The 12-week Phase 2a open-label study enrolled 12 patients with moderate to severe AUD and evaluated the safety, tolerability, pharmacodynamic effects and impact on alcohol use of a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy. The results demonstrated meaningful and sustained reductions in alcohol use following a single dose of BPL-003: Mean number of alcohol units consumed per day decreased from 9.3 units to 2.2 units at Week 12; Mean percentage of HDDs, defined as consuming seven or more units of alcohol per day for women and nine or more units of alcohol per day for men, declined from 56% to 13% at Week 12; Mean number of abstinent days increased from 33% to 81% at Week 12; 50% of the patients remained completely abstinent through the 12-week study; BPL-003 was shown to be well-tolerated with adverse events being reported as mild or moderate and there were no serious or severe adverse events reported. Most patients were assessed as ready for discharge within approximately two hours. Beckley Psytech plans to evaluate future development options for BPL-003 in substance use disorders and anticipates reporting additional clinical data from this study in publications and conferences in 2025.

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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.